AB 447: Medi-Cal: covered benefits: continuous glucose monitors.
- Session Year: 2017-2018
- House: Assembly
- Latest Version Date: 2017-09-13
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed by, and funded pursuant to, federal Medicaid program provisions. Existing law provides for a schedule of covered benefits under the Medi-Cal program. Existing law also generally requires pharmaceutical manufacturers to provide to the department a state rebate for certain drug products that have been added to the list of Medi-Cal contract drugs, that are approved for the treatment of acquired immunodeficiency syndrome (AIDS), or an AIDS-related condition, or cancer, and that are reimbursed through the Medi-Cal outpatient fee-for-service drug program, as specified.
This bill would, to the extent that federal financial participation is available and any necessary federal approvals have been obtained, add continuous glucose monitors and related supplies required for use with those monitors to the schedule of benefits under the Medi-Cal program for the treatment of diabetes mellitus type 1 and diabetes mellitus type 2 when medically necessary, subject to utilization controls. The bill would also authorize the department to require the manufacturer of a continuous glucose monitor to enter into a rebate agreement with the department.
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed by, and funded pursuant to, federal Medicaid program provisions. Existing law provides for a schedule of covered benefits under the Medi-Cal program. Existing law also generally requires pharmaceutical manufacturers to provide to the department a state rebate for certain drug products that have been added to the list of Medi-Cal contract drugs, that are approved for the treatment of acquired immunodeficiency syndrome (AIDS), or an AIDS-related condition, or cancer, and that are reimbursed through the Medi-Cal outpatient fee-for-service drug program, as specified.
This bill would, to the extent that federal financial participation is available and any necessary federal approvals have been obtained, add continuous glucose monitors and related supplies required for use with those monitors to the schedule of benefits under the Medi-Cal program for the treatment of diabetes mellitus type 1 and diabetes mellitus type 2 when medically necessary, subject to utilization controls. The bill would also authorize the department to require the manufacturer of a continuous glucose monitor to enter into a rebate agreement with the department.
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed by, and funded pursuant to, federal Medicaid program provisions. Existing law provides for a schedule of covered benefits under the Medi-Cal program.
This bill would, to the extent that federal financial participation is available and any necessary federal approvals have been obtained, add continuous glucose monitors and related supplies required for use with those monitors to the schedule of benefits under the Medi-Cal program for the treatment of diabetes mellitus type 1 and diabetes mellitus type 2 when medically necessary and when specified criteria are met. necessary, subject to utilization controls.
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed by, and funded pursuant to, federal Medicaid Program program provisions. Existing law provides for a schedule of covered benefits under the Medi-Cal program.
This bill would, to the extent that federal financial participation is available and any necessary federal approvals have been obtained, add continuous glucose monitors that are medically necessary for the management and treatment of diabetes and related supplies required for use with those monitors to the schedule of benefits under the Medi-Cal program. program for the treatment of diabetes mellitus type 1 and diabetes mellitus type 2 when medically necessary and when specified criteria are met.
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed by, and funded pursuant to, federal Medicaid Program provisions. Existing law provides for a schedule of covered benefits under the Medi-Cal program.
This bill would, to the extent that federal financial participation is available and any necessary federal approvals have been obtained, add continuous glucose monitors that are medically necessary for the management and treatment of diabetes to the schedule of benefits under the Medi-Cal program.
The following is the schedule of benefits under this chapter:
(a)Outpatient services are covered as follows:
Physician, hospital or clinic outpatient, surgical center, respiratory care, optometric, chiropractic, psychology, podiatric, occupational therapy, physical therapy, speech therapy, audiology, acupuncture to the extent federal matching funds are provided for acupuncture, and services of persons rendering treatment by prayer or healing by spiritual means in the practice of any church or religious denomination insofar as these can be encompassed by federal participation under an approved plan, subject to utilization controls.
(b)(1)Inpatient hospital services, including, but not limited to, physician and podiatric services, physical therapy, and occupational therapy, are covered subject to utilization controls.
(2)For Medi-Cal fee-for-service beneficiaries, emergency services and care that are necessary for the treatment of an emergency medical condition and medical care directly related to the emergency medical condition. This paragraph shall not be construed to change the obligation of Medi-Cal managed care plans to provide emergency services and care. For the purposes of this paragraph, emergency services and care and emergency medical condition shall have the same meanings as those terms are defined in Section 1317.1 of the Health and Safety Code.
(c)Nursing facility services, subacute care services, and services provided by any category of intermediate care facility for the developmentally disabled, including podiatry, physician, nurse practitioner services, and prescribed drugs, as described in subdivision (d), are covered subject to utilization controls. Respiratory care, physical therapy, occupational therapy, speech therapy, and audiology services for patients in nursing facilities and any category of intermediate care facility for the developmentally disabled are covered subject to utilization controls.
(d)(1)Purchase of prescribed drugs is covered subject to the Medi-Cal List of Contract Drugs and utilization controls.
(2)Purchase of drugs used to treat erectile dysfunction or any off-label uses of those drugs are covered only to the extent that federal financial participation is available.
(3)(A)To the extent required by federal law, the purchase of outpatient prescribed drugs, for which the prescription is executed by a prescriber in written, nonelectronic form on or after April 1, 2008, is covered only when executed on a tamper resistant prescription form. The implementation of this paragraph shall conform to the guidance issued by the federal Centers for Medicare and Medicaid Services but shall not conflict with state statutes on the characteristics of tamper resistant prescriptions for controlled substances, including Section 11162.1 of the Health and Safety Code. The department shall provide providers and beneficiaries with as much flexibility in implementing these rules as allowed by the federal government. The department shall notify and consult with appropriate stakeholders in implementing, interpreting, or making specific this paragraph.
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instructions without taking regulatory action.
(4)(A)(i)For the purposes of this paragraph, nonlegend has the same meaning as defined in subdivision (a) of Section 14105.45.
(ii)Nonlegend acetaminophen-containing products, with the exception of childrens acetaminophen-containing products, selected by the department are not covered benefits.
(iii)Nonlegend cough and cold products selected by the department are not covered benefits. This clause shall be implemented on the first day of the first calendar month following 90 days after the effective date of the act that added this clause, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(iv)Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from clauses (ii) and (iii).
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instruction without taking regulatory action.
(e)Outpatient dialysis services and home hemodialysis services, including physician services, medical supplies, drugs, and equipment required for dialysis, are covered, subject to utilization controls.
(f)Anesthesiologist services when provided as part of an outpatient medical procedure, nurse anesthetist services when rendered in an inpatient or outpatient setting under conditions set forth by the director, outpatient laboratory services, and X-ray services are covered, subject to utilization controls. Nothing in this subdivision shall be construed to require prior authorization for anesthesiologist services provided as part of an outpatient medical procedure or for portable X-ray services in a nursing facility or any category of intermediate care facility for the developmentally disabled.
(g)Blood and blood derivatives are covered.
(h)(1)Emergency and essential diagnostic and restorative dental services, except for orthodontic, fixed bridgework, and partial dentures that are not necessary for balance of a complete artificial denture, are covered, subject to utilization controls. The utilization controls shall allow emergency and essential diagnostic and restorative dental services and prostheses that are necessary to prevent a significant disability or to replace previously furnished prostheses that are lost or destroyed due to circumstances beyond the beneficiarys control. Notwithstanding the foregoing, the director may by regulation provide for certain fixed artificial dentures necessary for obtaining employment or for medical conditions that preclude the use of removable dental prostheses, and for orthodontic services in cleft palate deformities administered by the departments California Children Services Program.
(2)For persons 21 years of age or older, the services specified in paragraph (1) shall be provided subject to the following conditions:
(A)Periodontal treatment is not a benefit.
(B)Endodontic therapy is not a benefit except for vital pulpotomy.
(C)Laboratory processed crowns are not a benefit.
(D)Removable prosthetics shall be a benefit only for patients as a requirement for employment.
(E)The director may, by regulation, provide for the provision of fixed artificial dentures that are necessary for medical conditions that preclude the use of removable dental prostheses.
(F)Notwithstanding the conditions specified in subparagraphs (A) to (E), inclusive, the department may approve services for persons with special medical disorders subject to utilization review.
(3)Paragraph (2) shall become inoperative July 1, 1995.
(i)Medical transportation is covered, subject to utilization controls.
(j)Home health care services are covered, subject to utilization controls.
(k)Prosthetic and orthotic devices and eyeglasses are covered, subject to utilization controls. Utilization controls shall allow replacement of prosthetic and orthotic devices and eyeglasses necessary because of loss or destruction due to circumstances beyond the beneficiarys control. Frame styles for eyeglasses replaced pursuant to this subdivision shall not change more than once every two years, unless the department so directs.
Orthopedic and conventional shoes are covered when provided by a prosthetic and orthotic supplier on the prescription of a physician and when at least one of the shoes will be attached to a prosthesis or brace, subject to utilization controls. Modification of stock conventional or orthopedic shoes when medically indicated, is covered subject to utilization controls. When there is a clearly established medical need that cannot be satisfied by the modification of stock conventional or orthopedic shoes, custom-made orthopedic shoes are covered, subject to utilization controls.
Therapeutic shoes and inserts are covered when provided to beneficiaries with a diagnosis of diabetes, subject to utilization controls, to the extent that federal financial participation is available.
(l)Hearing aids are covered, subject to utilization controls. Utilization controls shall allow replacement of hearing aids necessary because of loss or destruction due to circumstances beyond the beneficiarys control.
(m)Durable medical equipment and medical supplies are covered, subject to utilization controls. The utilization controls shall allow the replacement of durable medical equipment and medical supplies when necessary because of loss or destruction due to circumstances beyond the beneficiarys control. The utilization controls shall allow authorization of durable medical equipment needed to assist a disabled beneficiary in caring for a child for whom the disabled beneficiary is a parent, stepparent, foster parent, or legal guardian, subject to the availability of federal financial participation. The department shall adopt emergency regulations to define and establish criteria for assistive durable medical equipment in accordance with the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code).
(n)Family planning services are covered, subject to utilization controls. However, for Medi-Cal managed care plans, any utilization controls shall be subject to Section 1367.25 of the Health and Safety Code.
(o)Inpatient intensive rehabilitation hospital services, including respiratory rehabilitation services, in a general acute care hospital are covered, subject to utilization controls, when either of the following criteria are met:
(1)A patient with a permanent disability or severe impairment requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to develop function beyond the limited amount that would occur in the normal course of recovery.
(2)A patient with a chronic or progressive disease requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to maintain the patients present functional level as long as possible.
(p)(1)Adult day health care is covered in accordance with Chapter 8.7 (commencing with Section 14520).
(2)Commencing 30 days after the effective date of the act that added this paragraph, and notwithstanding the number of days previously approved through a treatment authorization request, adult day health care is covered for a maximum of three days per week.
(3)As provided in accordance with paragraph (4), adult day health care is covered for a maximum of five days per week.
(4)As of the date that the director makes the declaration described in subdivision (g) of Section 14525.1, paragraph (2) shall become inoperative and paragraph (3) shall become operative.
(q)(1)Application of fluoride, or other appropriate fluoride treatment as defined by the department, and other prophylaxis treatment for children 17 years of age and under are covered.
(2)All dental hygiene services provided by a registered dental hygienist, registered dental hygienist in extended functions, and registered dental hygienist in alternative practice licensed pursuant to Sections 1753, 1917, 1918, and 1922 of the Business and Professions Code may be covered as long as they are within the scope of Denti-Cal benefits and they are necessary services provided by a registered dental hygienist, registered dental hygienist in extended functions, or registered dental hygienist in alternative practice.
(r)(1)Paramedic services performed by a city, county, or special district, or pursuant to a contract with a city, county, or special district, and pursuant to a program established under former Article 3 (commencing with Section 1480) of Chapter 2.5 of Division 2 of the Health and Safety Code by a paramedic certified pursuant to that article, and consisting of defibrillation and those services specified in subdivision (3) of former Section 1482 of the article.
(2)All providers enrolled under this subdivision shall satisfy all applicable statutory and regulatory requirements for becoming a Medi-Cal provider.
(3)This subdivision shall be implemented only to the extent funding is available under Section 14106.6.
(s)In-home medical care services are covered when medically appropriate and subject to utilization controls, for beneficiaries who would otherwise require care for an extended period of time in an acute care hospital at a cost higher than in-home medical care services. The director shall have the authority under this section to contract with organizations qualified to provide in-home medical care services to those persons. These services may be provided to patients placed in shared or congregate living arrangements, if a home setting is not medically appropriate or available to the beneficiary. As used in this section, in-home medical care service includes utility bills directly attributable to continuous, 24-hour operation of life-sustaining medical equipment, to the extent that federal financial participation is available.
As used in this subdivision, in-home medical care services include, but are not limited to:
(1)Level-of-care and cost-of-care evaluations.
(2)Expenses, directly attributable to home care activities, for materials.
(3)Physician fees for home visits.
(4)Expenses directly attributable to home care activities for shelter and modification to shelter.
(5)Expenses directly attributable to additional costs of special diets, including tube feeding.
(6)Medically related personal services.
(7)Home nursing education.
(8)Emergency maintenance repair.
(9)Home health agency personnel benefits that permit coverage of care during periods when regular personnel are on vacation or using sick leave.
(10)All services needed to maintain antiseptic conditions at stoma or shunt sites on the body.
(11)Emergency and nonemergency medical transportation.
(12)Medical supplies.
(13)Medical equipment, including, but not limited to, scales, gurneys, and equipment racks suitable for paralyzed patients.
(14)Utility use directly attributable to the requirements of home care activities that are in addition to normal utility use.
(15)Special drugs and medications.
(16)Home health agency supervision of visiting staff that is medically necessary, but not included in the home health agency rate.
(17)Therapy services.
(18)Household appliances and household utensil costs directly attributable to home care activities.
(19)Modification of medical equipment for home use.
(20)Training and orientation for use of life-support systems, including, but not limited to, support of respiratory functions.
(21)Respiratory care practitioner services as defined in Sections 3702 and 3703 of the Business and Professions Code, subject to prescription by a physician and surgeon.
Beneficiaries receiving in-home medical care services are entitled to the full range of services within the Medi-Cal scope of benefits as defined by this section, subject to medical necessity and applicable utilization control. Services provided pursuant to this subdivision, which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with a home- and community-based services waiver.
(t)Home- and community-based services approved by the United States Department of Health and Human Services are covered to the extent that federal financial participation is available for those services under the state plan or waivers granted in accordance with Section 1315 or 1396n of Title 42 of the United States Code. The director may seek waivers for any or all home- and community-based services approvable under Section 1315 or 1396n of Title 42 of the United States Code. Coverage for those services shall be limited by the terms, conditions, and duration of the federal waivers.
(u)Comprehensive perinatal services, as provided through an agreement with a health care provider designated in Section 14134.5 and meeting the standards developed by the department pursuant to Section 14134.5, subject to utilization controls.
The department shall seek any federal waivers necessary to implement the provisions of this subdivision. The provisions for which appropriate federal waivers cannot be obtained shall not be implemented. Provisions for which waivers are obtained or for which waivers are not required shall be implemented notwithstanding any inability to obtain federal waivers for the other provisions. No provision of this subdivision shall be implemented unless matching funds from Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code are available.
(v)Early and periodic screening, diagnosis, and treatment for any individual under 21 years of age is covered, consistent with the requirements of Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code.
(w)Hospice service which is Medicare-certified hospice service is covered, subject to utilization controls. Coverage shall be available only to the extent that no additional net program costs are incurred.
(x)When a claim for treatment provided to a beneficiary includes both services that are authorized and reimbursable under this chapter, and services that are not reimbursable under this chapter, that portion of the claim for the treatment and services authorized and reimbursable under this chapter shall be payable.
(y)Home- and community-based services approved by the United States Department of Health and Human Services for beneficiaries with a diagnosis of AIDS or ARC, who require intermediate care or a higher level of care.
Services provided pursuant to a waiver obtained from the Secretary of the United States Department of Health and Human Services pursuant to this subdivision, and which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with the waiver, and subject to the terms, conditions, and duration of the waiver. These services shall be provided to individual beneficiaries in accordance with the clients needs as identified in the plan of care, and subject to medical necessity and applicable utilization control.
The director may under this section contract with organizations qualified to provide, directly or by subcontract, services provided for in this subdivision to eligible beneficiaries. Contracts or agreements entered into pursuant to this division shall not be subject to the Public Contract Code.
(z)Respiratory care when provided in organized health care systems as defined in Section 3701 of the Business and Professions Code, and as an in-home medical service as outlined in subdivision (s).
(aa)(1)There is hereby established in the department, a program to provide comprehensive clinical family planning services to any person who has a family income at or below 200 percent of the federal poverty level, as revised annually, and who is eligible to receive these services pursuant to the waiver identified in paragraph (2). This program shall be known as the Family Planning, Access, Care, and Treatment (Family PACT) Program.
(2)The department shall seek a waiver in accordance with Section 1315 of Title 42 of the United States Code, or a state plan amendment adopted in accordance with Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code, which was added to Section 1396a of Title 42 of the United States Code by Section 2303(a)(2) of the federal Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), for a program to provide comprehensive clinical family planning services as described in paragraph (8). Under the waiver, the program shall be operated only in accordance with the waiver and the statutes and regulations in paragraph (4) and subject to the terms, conditions, and duration of the waiver. Under the state plan amendment, which shall replace the waiver and shall be known as the Family PACT successor state plan amendment, the program shall be operated only in accordance with this subdivision and the statutes and regulations in paragraph (4). The state shall use the standards and processes imposed by the state on January 1, 2007, including the application of an eligibility discount factor to the extent required by the federal Centers for Medicare and Medicaid Services, for purposes of determining eligibility as permitted under Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code. To the extent that federal financial participation is available, the program shall continue to conduct education, outreach, enrollment, service delivery, and evaluation services as specified under the waiver. The services shall be provided under the program only if the waiver and, when applicable, the successor state plan amendment are approved by the federal Centers for Medicare and Medicaid Services and only to the extent that federal financial participation is available for the services. Nothing in this section shall prohibit the department from seeking the Family PACT successor state plan amendment during the operation of the waiver.
(3)Solely for the purposes of the waiver or Family PACT successor state plan amendment and notwithstanding any other law, the collection and use of an individuals social security number shall be necessary only to the extent required by federal law.
(4)Sections 14105.3 to 14105.39, inclusive, 14107.11, 24005, and 24013, and any regulations adopted under these statutes shall apply to the program provided for under this subdivision. No other provision of law under the Medi-Cal program or the State-Only Family Planning Program shall apply to the program provided for under this subdivision.
(5)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement, without taking regulatory action, the provisions of the waiver after its approval by the federal Centers for Medicare and Medicaid Services and the provisions of this section by means of an all-county letter or similar instruction to providers. Thereafter, the department shall adopt regulations to implement this section and the approved waiver in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Beginning six months after the effective date of the act adding this subdivision, the department shall provide a status report to the Legislature on a semiannual basis until regulations have been adopted.
(6)In the event that the Department of Finance determines that the program operated under the authority of the waiver described in paragraph (2) or the Family PACT successor state plan amendment is no longer cost effective, this subdivision shall become inoperative on the first day of the first month following the issuance of a 30-day notification of that determination in writing by the Department of Finance to the chairperson in each house that considers appropriations, the chairpersons of the committees, and the appropriate subcommittees in each house that considers the State Budget, and the Chairperson of the Joint Legislative Budget Committee.
(7)If this subdivision ceases to be operative, all persons who have received or are eligible to receive comprehensive clinical family planning services pursuant to the waiver described in paragraph (2) shall receive family planning services under the Medi-Cal program pursuant to subdivision (n) if they are otherwise eligible for Medi-Cal with no share of cost, or shall receive comprehensive clinical family planning services under the program established in Division 24 (commencing with Section 24000) either if they are eligible for Medi-Cal with a share of cost or if they are otherwise eligible under Section 24003.
(8)For purposes of this subdivision, comprehensive clinical family planning services means the process of establishing objectives for the number and spacing of children, and selecting the means by which those objectives may be achieved. These means include a broad range of acceptable and effective methods and services to limit or enhance fertility, including contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, natural family planning, abstinence methods, and basic, limited fertility management. Comprehensive clinical family planning services include, but are not limited to, preconception counseling, maternal and fetal health counseling, general reproductive health care, including diagnosis and treatment of infections and conditions, including cancer, that threaten reproductive capability, medical family planning treatment and procedures, including supplies and followup, and informational, counseling, and educational services. Comprehensive clinical family planning services shall not include abortion, pregnancy testing solely for the purposes of referral for abortion or services ancillary to abortions, or pregnancy care that is not incident to the diagnosis of pregnancy. Comprehensive clinical family planning services shall be subject to utilization control and include all of the following:
(A)Family planning related services and male and female sterilization. Family planning services for men and women shall include emergency services and services for complications directly related to the contraceptive method, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, and followup, consultation, and referral services, as indicated, which may require treatment authorization requests.
(B)All United States Department of Agriculture, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies that are in keeping with current standards of practice and from which the individual may choose.
(C)Culturally and linguistically appropriate health education and counseling services, including informed consent, that include all of the following:
(i)Psychosocial and medical aspects of contraception.
(ii)Sexuality.
(iii)Fertility.
(iv)Pregnancy.
(v)Parenthood.
(vi)Infertility.
(vii)Reproductive health care.
(viii)Preconception and nutrition counseling.
(ix)Prevention and treatment of sexually transmitted infection.
(x)Use of contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies.
(xi)Possible contraceptive consequences and followup.
(xii)Interpersonal communication and negotiation of relationships to assist individuals and couples in effective contraceptive method use and planning families.
(D)A comprehensive health history, updated at the next periodic visit (between 11 and 24 months after initial examination) that includes a complete obstetrical history, gynecological history, contraceptive history, personal medical history, health risk factors, and family health history, including genetic or hereditary conditions.
(E)A complete physical examination on initial and subsequent periodic visits.
(F)Services, drugs, devices, and supplies deemed by the federal Centers for Medicare and Medicaid Services to be appropriate for inclusion in the program.
(9)In order to maximize the availability of federal financial participation under this subdivision, the director shall have the discretion to implement the Family PACT successor state plan amendment retroactively to July 1, 2010.
(ab)(1)Purchase of prescribed enteral nutrition products is covered, subject to the Medi-Cal list of enteral nutrition products and utilization controls.
(2)Purchase of enteral nutrition products is limited to those products to be administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube. Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from this paragraph.
(3)Notwithstanding paragraph (2), the department may deem an enteral nutrition product, not administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube, a benefit for patients with diagnoses, including, but not limited to, malabsorption and inborn errors of metabolism, if the product has been shown to be neither investigational nor experimental when used as part of a therapeutic regimen to prevent serious disability or death.
(4)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement the amendments to this subdivision made by the act that added this paragraph by means of all-county letters, provider bulletins, or similar instructions, without taking regulatory action.
(5)The amendments made to this subdivision by the act that added this paragraph shall be implemented June 1, 2011, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(ac)Diabetic testing supplies are covered when provided by a pharmacy, subject to utilization controls.
(ad)(1)Nonmedical transportation is covered, subject to utilization controls and permissible time and distance standards, for a beneficiary to obtain covered Medi-Cal services.
(2)(A)(i)Nonmedical transportation includes, at a minimum, round trip transportation for a beneficiary to obtain covered Medi-Cal services by passenger car, taxicab, or any other form of public or private conveyance, and mileage reimbursement when conveyance is in a private vehicle arranged by the beneficiary and not through a transportation broker, bus passes, taxi vouchers, or train tickets.
(ii)Nonmedical transportation does not include the transportation of sick, injured, invalid, convalescent, infirm, or otherwise incapacitated beneficiaries by ambulances, litter vans, or wheelchair vans licensed, operated, and equipped in accordance with state and local statutes, ordinances, or regulations.
(B)Nonmedical transportation shall be provided for a beneficiary who can attest in a manner to be specified by the department that other currently available resources have been reasonably exhausted. For beneficiaries enrolled in a managed care plan, nonmedical transportation shall be provided by the beneficiarys managed care plan. For Medi-Cal fee-for-service beneficiaries, the department shall provide nonmedical transportation when those services are not available to the beneficiary under Sections 14132.44 and 14132.47.
(3)Nonmedical transportation shall be provided in a form and manner that is accessible, in terms of physical and geographic accessibility, for the beneficiary and consistent with applicable state and federal disability rights laws.
(4)It is the intent of the Legislature in enacting this subdivision to affirm the requirement under Section 431.53 of Title 42 of the Code of Federal Regulations, in which the department is required to provide necessary transportation, including nonmedical transportation, for recipients to and from covered services. This subdivision shall not be interpreted to add a new benefit to the Medi-Cal program.
(5)The department shall seek any federal approvals that may be required to implement this subdivision, including, but not limited to, approval of revisions to the existing state plan that the department determines are necessary to implement this subdivision.
(6)This subdivision shall be implemented only to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained.
(7)Prior to the effective date of any necessary federal approvals, nonmedical transportation was not a Medi-Cal managed care benefit with the exception of when provided as an Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) service.
(8)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department, without taking any further regulatory action, shall implement, interpret, or make specific this subdivision by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions until the time regulations are adopted. By July 1, 2018, the department shall adopt regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Commencing January 1, 2018, and notwithstanding Section 10231.5 of the Government Code, the department shall provide a status report to the Legislature on a semiannual basis, in compliance with Section 9795 of the Government Code, until regulations have been adopted.
(9)This subdivision shall not be implemented until July 1, 2017.
(ae)(1)Continuous glucose monitors and related supplies required for use with those monitors are covered for the treatment of diabetes mellitus when medically necessary, subject to utilization controls. The department may require the manufacturer of a continuous glucose monitor to enter into a rebate agreement with the department.
(2)This subdivision shall be implemented only to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
The following is the schedule of benefits under this chapter:
(a)Outpatient services are covered as follows:
Physician, hospital or clinic outpatient, surgical center, respiratory care, optometric, chiropractic, psychology, podiatric, occupational therapy, physical therapy, speech therapy, audiology, acupuncture to the extent federal matching funds are provided for acupuncture, and services of persons rendering treatment by prayer or healing by spiritual means in the practice of any church or religious denomination insofar as these can be encompassed by federal participation under an approved plan, subject to utilization controls.
(b)(1)Inpatient hospital services, including, but not limited to, physician and podiatric services, physical therapy, and occupational therapy, are covered subject to utilization controls.
(2)For Medi-Cal fee-for-service beneficiaries, emergency services and care that are necessary for the treatment of an emergency medical condition and medical care directly related to the emergency medical condition. This paragraph shall not be construed to change the obligation of Medi-Cal managed care plans to provide emergency services and care. For the purposes of this paragraph, emergency services and care and emergency medical condition shall have the same meanings as those terms are defined in Section 1317.1 of the Health and Safety Code.
(c)Nursing facility services, subacute care services, and services provided by any category of intermediate care facility for the developmentally disabled, including podiatry, physician, nurse practitioner services, and prescribed drugs, as described in subdivision (d), are covered subject to utilization controls. Respiratory care, physical therapy, occupational therapy, speech therapy, and audiology services for patients in nursing facilities and any category of intermediate care facility for the developmentally disabled are covered subject to utilization controls.
(d)(1)Purchase of prescribed drugs is covered subject to the Medi-Cal List of Contract Drugs and utilization controls.
(2)Purchase of drugs used to treat erectile dysfunction or any off-label uses of those drugs are covered only to the extent that federal financial participation is available.
(3)(A)To the extent required by federal law, the purchase of outpatient prescribed drugs, for which the prescription is executed by a prescriber in written, nonelectronic form on or after April 1, 2008, is covered only when executed on a tamper resistant prescription form. The implementation of this paragraph shall conform to the guidance issued by the federal Centers for Medicare and Medicaid Services but shall not conflict with state statutes on the characteristics of tamper resistant prescriptions for controlled substances, including Section 11162.1 of the Health and Safety Code. The department shall provide providers and beneficiaries with as much flexibility in implementing these rules as allowed by the federal government. The department shall notify and consult with appropriate stakeholders in implementing, interpreting, or making specific this paragraph.
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instructions without taking regulatory action.
(4)(A)(i)For the purposes of this paragraph, nonlegend has the same meaning as defined in subdivision (a) of Section 14105.45.
(ii)Nonlegend acetaminophen-containing products, with the exception of childrens acetaminophen-containing products, selected by the department are not covered benefits.
(iii)Nonlegend cough and cold products selected by the department are not covered benefits. This clause shall be implemented on the first day of the first calendar month following 90 days after the effective date of the act that added this clause, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(iv)Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from clauses (ii) and (iii).
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instruction without taking regulatory action.
(e)Outpatient dialysis services and home hemodialysis services, including physician services, medical supplies, drugs, and equipment required for dialysis, are covered, subject to utilization controls.
(f)Anesthesiologist services when provided as part of an outpatient medical procedure, nurse anesthetist services when rendered in an inpatient or outpatient setting under conditions set forth by the director, outpatient laboratory services, and X-ray services are covered, subject to utilization controls. Nothing in this subdivision shall be construed to require prior authorization for anesthesiologist services provided as part of an outpatient medical procedure or for portable X-ray services in a nursing facility or any category of intermediate care facility for the developmentally disabled.
(g)Blood and blood derivatives are covered.
(h)(1)Emergency and essential diagnostic and restorative dental services, except for orthodontic, fixed bridgework, and partial dentures that are not necessary for balance of a complete artificial denture, are covered, subject to utilization controls. The utilization controls shall allow emergency and essential diagnostic and restorative dental services and prostheses that are necessary to prevent a significant disability or to replace previously furnished prostheses that are lost or destroyed due to circumstances beyond the beneficiarys control. Notwithstanding the foregoing, the director may by regulation provide for certain fixed artificial dentures necessary for obtaining employment or for medical conditions that preclude the use of removable dental prostheses, and for orthodontic services in cleft palate deformities administered by the departments California Children Services Program.
(2)For persons 21 years of age or older, the services specified in paragraph (1) shall be provided subject to the following conditions:
(A)Periodontal treatment is not a benefit.
(B)Endodontic therapy is not a benefit except for vital pulpotomy.
(C)Laboratory processed crowns are not a benefit.
(D)Removable prosthetics shall be a benefit only for patients as a requirement for employment.
(E)The director may, by regulation, provide for the provision of fixed artificial dentures that are necessary for medical conditions that preclude the use of removable dental prostheses.
(F)Notwithstanding the conditions specified in subparagraphs (A) to (E), inclusive, the department may approve services for persons with special medical disorders subject to utilization review.
(3)Paragraph (2) shall become inoperative July 1, 1995.
(i)Medical transportation is covered, subject to utilization controls.
(j)Home health care services are covered, subject to utilization controls.
(k)Prosthetic and orthotic devices and eyeglasses are covered, subject to utilization controls. Utilization controls shall allow replacement of prosthetic and orthotic devices and eyeglasses necessary because of loss or destruction due to circumstances beyond the beneficiarys control. Frame styles for eyeglasses replaced pursuant to this subdivision shall not change more than once every two years, unless the department so directs.
Orthopedic and conventional shoes are covered when provided by a prosthetic and orthotic supplier on the prescription of a physician and when at least one of the shoes will be attached to a prosthesis or brace, subject to utilization controls. Modification of stock conventional or orthopedic shoes when medically indicated, is covered subject to utilization controls. When there is a clearly established medical need that cannot be satisfied by the modification of stock conventional or orthopedic shoes, custom-made orthopedic shoes are covered, subject to utilization controls.
Therapeutic shoes and inserts are covered when provided to beneficiaries with a diagnosis of diabetes, subject to utilization controls, to the extent that federal financial participation is available.
(l)Hearing aids are covered, subject to utilization controls. Utilization controls shall allow replacement of hearing aids necessary because of loss or destruction due to circumstances beyond the beneficiarys control.
(m)Durable medical equipment and medical supplies are covered, subject to utilization controls. The utilization controls shall allow the replacement of durable medical equipment and medical supplies when necessary because of loss or destruction due to circumstances beyond the beneficiarys control. The utilization controls shall allow authorization of durable medical equipment needed to assist a disabled beneficiary in caring for a child for whom the disabled beneficiary is a parent, stepparent, foster parent, or legal guardian, subject to the availability of federal financial participation. The department shall adopt emergency regulations to define and establish criteria for assistive durable medical equipment in accordance with the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code).
(n)Family planning services are covered, subject to utilization controls. However, for Medi-Cal managed care plans, any utilization controls shall be subject to Section 1367.25 of the Health and Safety Code.
(o)Inpatient intensive rehabilitation hospital services, including respiratory rehabilitation services, in a general acute care hospital are covered, subject to utilization controls, when either of the following criteria are met:
(1)A patient with a permanent disability or severe impairment requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to develop function beyond the limited amount that would occur in the normal course of recovery.
(2)A patient with a chronic or progressive disease requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to maintain the patients present functional level as long as possible.
(p)(1)Adult day health care is covered in accordance with Chapter 8.7 (commencing with Section 14520).
(2)Commencing 30 days after the effective date of the act that added this paragraph, and notwithstanding the number of days previously approved through a treatment authorization request, adult day health care is covered for a maximum of three days per week.
(3)As provided in accordance with paragraph (4), adult day health care is covered for a maximum of five days per week.
(4)As of the date that the director makes the declaration described in subdivision (g) of Section 14525.1, paragraph (2) shall become inoperative and paragraph (3) shall become operative.
(q)(1)Application of fluoride, or other appropriate fluoride treatment as defined by the department, and other prophylaxis treatment for children 17 years of age and under are covered.
(2)All dental hygiene services provided by a registered dental hygienist, registered dental hygienist in extended functions, and registered dental hygienist in alternative practice licensed pursuant to Sections 1753, 1917, 1918, and 1922 of the Business and Professions Code may be covered as long as they are within the scope of Denti-Cal benefits and they are necessary services provided by a registered dental hygienist, registered dental hygienist in extended functions, or registered dental hygienist in alternative practice.
(r)(1)Paramedic services performed by a city, county, or special district, or pursuant to a contract with a city, county, or special district, and pursuant to a program established under former Article 3 (commencing with Section 1480) of Chapter 2.5 of Division 2 of the Health and Safety Code by a paramedic certified pursuant to that article, and consisting of defibrillation and those services specified in subdivision (3) of former Section 1482 of the article.
(2)All providers enrolled under this subdivision shall satisfy all applicable statutory and regulatory requirements for becoming a Medi-Cal provider.
(3)This subdivision shall be implemented only to the extent funding is available under Section 14106.6.
(s)In-home medical care services are covered when medically appropriate and subject to utilization controls, for beneficiaries who would otherwise require care for an extended period of time in an acute care hospital at a cost higher than in-home medical care services. The director shall have the authority under this section to contract with organizations qualified to provide in-home medical care services to those persons. These services may be provided to patients placed in shared or congregate living arrangements, if a home setting is not medically appropriate or available to the beneficiary. As used in this section, in-home medical care service includes utility bills directly attributable to continuous, 24-hour operation of life-sustaining medical equipment, to the extent that federal financial participation is available.
As used in this subdivision, in-home medical care services include, but are not limited to:
(1)Level-of-care and cost-of-care evaluations.
(2)Expenses, directly attributable to home care activities, for materials.
(3)Physician fees for home visits.
(4)Expenses directly attributable to home care activities for shelter and modification to shelter.
(5)Expenses directly attributable to additional costs of special diets, including tube feeding.
(6)Medically related personal services.
(7)Home nursing education.
(8)Emergency maintenance repair.
(9)Home health agency personnel benefits that permit coverage of care during periods when regular personnel are on vacation or using sick leave.
(10)All services needed to maintain antiseptic conditions at stoma or shunt sites on the body.
(11)Emergency and nonemergency medical transportation.
(12)Medical supplies.
(13)Medical equipment, including, but not limited to, scales, gurneys, and equipment racks suitable for paralyzed patients.
(14)Utility use directly attributable to the requirements of home care activities that are in addition to normal utility use.
(15)Special drugs and medications.
(16)Home health agency supervision of visiting staff that is medically necessary, but not included in the home health agency rate.
(17)Therapy services.
(18)Household appliances and household utensil costs directly attributable to home care activities.
(19)Modification of medical equipment for home use.
(20)Training and orientation for use of life-support systems, including, but not limited to, support of respiratory functions.
(21)Respiratory care practitioner services as defined in Sections 3702 and 3703 of the Business and Professions Code, subject to prescription by a physician and surgeon.
Beneficiaries receiving in-home medical care services are entitled to the full range of services within the Medi-Cal scope of benefits as defined by this section, subject to medical necessity and applicable utilization control. Services provided pursuant to this subdivision, which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with a home- and community-based services waiver.
(t)Home- and community-based services approved by the United States Department of Health and Human Services are covered to the extent that federal financial participation is available for those services under the state plan or waivers granted in accordance with Section 1315 or 1396n of Title 42 of the United States Code. The director may seek waivers for any or all home- and community-based services approvable under Section 1315 or 1396n of Title 42 of the United States Code. Coverage for those services shall be limited by the terms, conditions, and duration of the federal waivers.
(u)Comprehensive perinatal services, as provided through an agreement with a health care provider designated in Section 14134.5 and meeting the standards developed by the department pursuant to Section 14134.5, subject to utilization controls.
The department shall seek any federal waivers necessary to implement the provisions of this subdivision. The provisions for which appropriate federal waivers cannot be obtained shall not be implemented. Provisions for which waivers are obtained or for which waivers are not required shall be implemented notwithstanding any inability to obtain federal waivers for the other provisions. No provision of this subdivision shall be implemented unless matching funds from Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code are available.
(v)Early and periodic screening, diagnosis, and treatment for any individual under 21 years of age is covered, consistent with the requirements of Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code.
(w)Hospice service which is Medicare-certified hospice service is covered, subject to utilization controls. Coverage shall be available only to the extent that no additional net program costs are incurred.
(x)When a claim for treatment provided to a beneficiary includes both services that are authorized and reimbursable under this chapter, and services that are not reimbursable under this chapter, that portion of the claim for the treatment and services authorized and reimbursable under this chapter shall be payable.
(y)Home- and community-based services approved by the United States Department of Health and Human Services for beneficiaries with a diagnosis of AIDS or ARC, who require intermediate care or a higher level of care.
Services provided pursuant to a waiver obtained from the Secretary of the United States Department of Health and Human Services pursuant to this subdivision, and which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with the waiver, and subject to the terms, conditions, and duration of the waiver. These services shall be provided to individual beneficiaries in accordance with the clients needs as identified in the plan of care, and subject to medical necessity and applicable utilization control.
The director may under this section contract with organizations qualified to provide, directly or by subcontract, services provided for in this subdivision to eligible beneficiaries. Contracts or agreements entered into pursuant to this division shall not be subject to the Public Contract Code.
(z)Respiratory care when provided in organized health care systems as defined in Section 3701 of the Business and Professions Code, and as an in-home medical service as outlined in subdivision (s).
(aa)(1)There is hereby established in the department, a program to provide comprehensive clinical family planning services to any person who has a family income at or below 200 percent of the federal poverty level, as revised annually, and who is eligible to receive these services pursuant to the waiver identified in paragraph (2). This program shall be known as the Family Planning, Access, Care, and Treatment (Family PACT) Program.
(2)The department shall seek a waiver in accordance with Section 1315 of Title 42 of the United States Code, or a state plan amendment adopted in accordance with Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code, which was added to Section 1396a of Title 42 of the United States Code by Section 2303(a)(2) of the federal Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), for a program to provide comprehensive clinical family planning services as described in paragraph (8). Under the waiver, the program shall be operated only in accordance with the waiver and the statutes and regulations in paragraph (4) and subject to the terms, conditions, and duration of the waiver. Under the state plan amendment, which shall replace the waiver and shall be known as the Family PACT successor state plan amendment, the program shall be operated only in accordance with this subdivision and the statutes and regulations in paragraph (4). The state shall use the standards and processes imposed by the state on January 1, 2007, including the application of an eligibility discount factor to the extent required by the federal Centers for Medicare and Medicaid Services, for purposes of determining eligibility as permitted under Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code. To the extent that federal financial participation is available, the program shall continue to conduct education, outreach, enrollment, service delivery, and evaluation services as specified under the waiver. The services shall be provided under the program only if the waiver and, when applicable, the successor state plan amendment are approved by the federal Centers for Medicare and Medicaid Services and only to the extent that federal financial participation is available for the services. Nothing in this section shall prohibit the department from seeking the Family PACT successor state plan amendment during the operation of the waiver.
(3)Solely for the purposes of the waiver or Family PACT successor state plan amendment and notwithstanding any other law, the collection and use of an individuals social security number shall be necessary only to the extent required by federal law.
(4)Sections 14105.3 to 14105.39, inclusive, 14107.11, 24005, and 24013, and any regulations adopted under these statutes shall apply to the program provided for under this subdivision. No other provision of law under the Medi-Cal program or the State-Only Family Planning Program shall apply to the program provided for under this subdivision.
(5)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement, without taking regulatory action, the provisions of the waiver after its approval by the federal Centers for Medicare and Medicaid Services and the provisions of this section by means of an all-county letter or similar instruction to providers. Thereafter, the department shall adopt regulations to implement this section and the approved waiver in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Beginning six months after the effective date of the act adding this subdivision, the department shall provide a status report to the Legislature on a semiannual basis until regulations have been adopted.
(6)In the event that the Department of Finance determines that the program operated under the authority of the waiver described in paragraph (2) or the Family PACT successor state plan amendment is no longer cost effective, this subdivision shall become inoperative on the first day of the first month following the issuance of a 30-day notification of that determination in writing by the Department of Finance to the chairperson in each house that considers appropriations, the chairpersons of the committees, and the appropriate subcommittees in each house that considers the State Budget, and the Chairperson of the Joint Legislative Budget Committee.
(7)If this subdivision ceases to be operative, all persons who have received or are eligible to receive comprehensive clinical family planning services pursuant to the waiver described in paragraph (2) shall receive family planning services under the Medi-Cal program pursuant to subdivision (n) if they are otherwise eligible for Medi-Cal with no share of cost, or shall receive comprehensive clinical family planning services under the program established in Division 24 (commencing with Section 24000) either if they are eligible for Medi-Cal with a share of cost or if they are otherwise eligible under Section 24003.
(8)For purposes of this subdivision, comprehensive clinical family planning services means the process of establishing objectives for the number and spacing of children, and selecting the means by which those objectives may be achieved. These means include a broad range of acceptable and effective methods and services to limit or enhance fertility, including contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, natural family planning, abstinence methods, and basic, limited fertility management. Comprehensive clinical family planning services include, but are not limited to, preconception counseling, maternal and fetal health counseling, general reproductive health care, including diagnosis and treatment of infections and conditions, including cancer, that threaten reproductive capability, medical family planning treatment and procedures, including supplies and followup, and informational, counseling, and educational services. Comprehensive clinical family planning services shall not include abortion, pregnancy testing solely for the purposes of referral for abortion or services ancillary to abortions, or pregnancy care that is not incident to the diagnosis of pregnancy. Comprehensive clinical family planning services shall be subject to utilization control and include all of the following:
(A)Family planning related services and male and female sterilization. Family planning services for men and women shall include emergency services and services for complications directly related to the contraceptive method, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, and followup, consultation, and referral services, as indicated, which may require treatment authorization requests.
(B)All United States Department of Agriculture, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies that are in keeping with current standards of practice and from which the individual may choose.
(C)Culturally and linguistically appropriate health education and counseling services, including informed consent, that include all of the following:
(i)Psychosocial and medical aspects of contraception.
(ii)Sexuality.
(iii)Fertility.
(iv)Pregnancy.
(v)Parenthood.
(vi)Infertility.
(vii)Reproductive health care.
(viii)Preconception and nutrition counseling.
(ix)Prevention and treatment of sexually transmitted infection.
(x)Use of contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies.
(xi)Possible contraceptive consequences and followup.
(xii)Interpersonal communication and negotiation of relationships to assist individuals and couples in effective contraceptive method use and planning families.
(D)A comprehensive health history, updated at the next periodic visit (between 11 and 24 months after initial examination) that includes a complete obstetrical history, gynecological history, contraceptive history, personal medical history, health risk factors, and family health history, including genetic or hereditary conditions.
(E)A complete physical examination on initial and subsequent periodic visits.
(F)Services, drugs, devices, and supplies deemed by the federal Centers for Medicare and Medicaid Services to be appropriate for inclusion in the program.
(9)In order to maximize the availability of federal financial participation under this subdivision, the director shall have the discretion to implement the Family PACT successor state plan amendment retroactively to July 1, 2010.
(ab)(1)Purchase of prescribed enteral nutrition products is covered, subject to the Medi-Cal list of enteral nutrition products and utilization controls.
(2)Purchase of enteral nutrition products is limited to those products to be administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube. Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from this paragraph.
(3)Notwithstanding paragraph (2), the department may deem an enteral nutrition product, not administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube, a benefit for patients with diagnoses, including, but not limited to, malabsorption and inborn errors of metabolism, if the product has been shown to be neither investigational nor experimental when used as part of a therapeutic regimen to prevent serious disability or death.
(4)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement the amendments to this subdivision made by the act that added this paragraph by means of all-county letters, provider bulletins, or similar instructions, without taking regulatory action.
(5)The amendments made to this subdivision by the act that added this paragraph shall be implemented June 1, 2011, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(ac)Diabetic testing supplies are covered when provided by a pharmacy, subject to utilization controls.
(ad)(1)Nonmedical transportation is covered, subject to utilization controls and permissible time and distance standards, for a beneficiary to obtain covered Medi-Cal services.
(2)(A)(i)Nonmedical transportation includes, at a minimum, round trip transportation for a beneficiary to obtain covered Medi-Cal services by passenger car, taxicab, or any other form of public or private conveyance, and mileage reimbursement when conveyance is in a private vehicle arranged by the beneficiary and not through a transportation broker, bus passes, taxi vouchers, or train tickets.
(ii)Nonmedical transportation does not include the transportation of sick, injured, invalid, convalescent, infirm, or otherwise incapacitated beneficiaries by ambulances, litter vans, or wheelchair vans licensed, operated, and equipped in accordance with state and local statutes, ordinances, or regulations.
(B)Nonmedical transportation shall be provided for a beneficiary who can attest in a manner to be specified by the department that other currently available resources have been reasonably exhausted. For beneficiaries enrolled in a managed care plan, nonmedical transportation shall be provided by the beneficiarys managed care plan. For Medi-Cal fee-for-service beneficiaries, the department shall provide nonmedical transportation when those services are not available to the beneficiary under Sections 14132.44 and 14132.47.
(3)Nonmedical transportation shall be provided in a form and manner that is accessible, in terms of physical and geographic accessibility, for the beneficiary and consistent with applicable state and federal disability rights laws.
(4)It is the intent of the Legislature in enacting this subdivision to affirm the requirement under Section 431.53 of Title 42 of the Code of Federal Regulations, in which the department is required to provide necessary transportation, including nonmedical transportation, for recipients to and from covered services. This subdivision shall not be interpreted to add a new benefit to the Medi-Cal program.
(5)The department shall seek any federal approvals that may be required to implement this subdivision, including, but not limited to, approval of revisions to the existing state plan that the department determines are necessary to implement this subdivision.
(6)This subdivision shall be implemented only to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained.
(7)Prior to the effective date of any necessary federal approvals, nonmedical transportation was not a Medi-Cal managed care benefit with the exception of when provided as an Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) service.
(8)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department, without taking any further regulatory action, shall implement, interpret, or make specific this subdivision by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions until the time regulations are adopted. By July 1, 2018, the department shall adopt regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Commencing January 1, 2018, and notwithstanding Section 10231.5 of the Government Code, the department shall provide a status report to the Legislature on a semiannual basis, in compliance with Section 9795 of the Government Code, until regulations have been adopted.
(9)This subdivision shall not be implemented until July 1, 2017.
(ae)(1)Continuous glucose monitors and related supplies required for use with those monitors are covered for the treatment of diabetes mellitus when medically necessary, subject to utilization controls. The department may require the manufacturer of a continuous glucose monitor to enter into a rebate agreement with the department.
(2)This subdivision shall be implemented only to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
The following is the schedule of benefits under this chapter:
(a)Outpatient services are covered as follows:
Physician, hospital or clinic outpatient, surgical center, respiratory care, optometric, chiropractic, psychology, podiatric, occupational therapy, physical therapy, speech therapy, audiology, acupuncture to the extent federal matching funds are provided for acupuncture, and services of persons rendering treatment by prayer or healing by spiritual means in the practice of any church or religious denomination insofar as these can be encompassed by federal participation under an approved plan, subject to utilization controls.
(b)(1)Inpatient hospital services, including, but not limited to, physician and podiatric services, physical therapy, and occupational therapy, are covered subject to utilization controls.
(2)For Medi-Cal fee-for-service beneficiaries, emergency services and care that are necessary for the treatment of an emergency medical condition and medical care directly related to the emergency medical condition. This paragraph shall not be construed to change the obligation of Medi-Cal managed care plans to provide emergency services and care. For the purposes of this paragraph, emergency services and care and emergency medical condition shall have the same meanings as those terms are defined in Section 1317.1 of the Health and Safety Code.
(c)Nursing facility services, subacute care services, and services provided by any category of intermediate care facility for the developmentally disabled, including podiatry, physician, nurse practitioner services, and prescribed drugs, as described in subdivision (d), are covered subject to utilization controls. Respiratory care, physical therapy, occupational therapy, speech therapy, and audiology services for patients in nursing facilities and any category of intermediate care facility for the developmentally disabled are covered subject to utilization controls.
(d)(1)Purchase of prescribed drugs is covered subject to the Medi-Cal List of Contract Drugs and utilization controls.
(2)Purchase of drugs used to treat erectile dysfunction or any off-label uses of those drugs are covered only to the extent that federal financial participation is available.
(3)(A)To the extent required by federal law, the purchase of outpatient prescribed drugs, for which the prescription is executed by a prescriber in written, nonelectronic form on or after April 1, 2008, is covered only when executed on a tamper resistant prescription form. The implementation of this paragraph shall conform to the guidance issued by the federal Centers for Medicare and Medicaid Services but shall not conflict with state statutes on the characteristics of tamper resistant prescriptions for controlled substances, including Section 11162.1 of the Health and Safety Code. The department shall provide providers and beneficiaries with as much flexibility in implementing these rules as allowed by the federal government. The department shall notify and consult with appropriate stakeholders in implementing, interpreting, or making specific this paragraph.
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instructions without taking regulatory action.
(4)(A)(i)For the purposes of this paragraph, nonlegend has the same meaning as defined in subdivision (a) of Section 14105.45.
(ii)Nonlegend acetaminophen-containing products, with the exception of childrens acetaminophen-containing products, selected by the department are not covered benefits.
(iii)Nonlegend cough and cold products selected by the department are not covered benefits. This clause shall be implemented on the first day of the first calendar month following 90 days after the effective date of the act that added this clause, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(iv)Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from clauses (ii) and (iii).
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instruction without taking regulatory action.
(e)Outpatient dialysis services and home hemodialysis services, including physician services, medical supplies, drugs, and equipment required for dialysis, are covered, subject to utilization controls.
(f)Anesthesiologist services when provided as part of an outpatient medical procedure, nurse anesthetist services when rendered in an inpatient or outpatient setting under conditions set forth by the director, outpatient laboratory services, and X-ray services are covered, subject to utilization controls. Nothing in this subdivision shall be construed to require prior authorization for anesthesiologist services provided as part of an outpatient medical procedure or for portable X-ray services in a nursing facility or any category of intermediate care facility for the developmentally disabled.
(g)Blood and blood derivatives are covered.
(h)(1)Emergency and essential diagnostic and restorative dental services, except for orthodontic, fixed bridgework, and partial dentures that are not necessary for balance of a complete artificial denture, are covered, subject to utilization controls. The utilization controls shall allow emergency and essential diagnostic and restorative dental services and prostheses that are necessary to prevent a significant disability or to replace previously furnished prostheses that are lost or destroyed due to circumstances beyond the beneficiarys control. Notwithstanding the foregoing, the director may by regulation provide for certain fixed artificial dentures necessary for obtaining employment or for medical conditions that preclude the use of removable dental prostheses, and for orthodontic services in cleft palate deformities administered by the departments California Children Services Program.
(2)For persons 21 years of age or older, the services specified in paragraph (1) shall be provided subject to the following conditions:
(A)Periodontal treatment is not a benefit.
(B)Endodontic therapy is not a benefit except for vital pulpotomy.
(C)Laboratory processed crowns are not a benefit.
(D)Removable prosthetics shall be a benefit only for patients as a requirement for employment.
(E)The director may, by regulation, provide for the provision of fixed artificial dentures that are necessary for medical conditions that preclude the use of removable dental prostheses.
(F)Notwithstanding the conditions specified in subparagraphs (A) to (E), inclusive, the department may approve services for persons with special medical disorders subject to utilization review.
(3)Paragraph (2) shall become inoperative July 1, 1995.
(i)Medical transportation is covered, subject to utilization controls.
(j)Home health care services are covered, subject to utilization controls.
(k)Prosthetic and orthotic devices and eyeglasses are covered, subject to utilization controls. Utilization controls shall allow replacement of prosthetic and orthotic devices and eyeglasses necessary because of loss or destruction due to circumstances beyond the beneficiarys control. Frame styles for eyeglasses replaced pursuant to this subdivision shall not change more than once every two years, unless the department so directs.
Orthopedic and conventional shoes are covered when provided by a prosthetic and orthotic supplier on the prescription of a physician and when at least one of the shoes will be attached to a prosthesis or brace, subject to utilization controls. Modification of stock conventional or orthopedic shoes when medically indicated, is covered subject to utilization controls. When there is a clearly established medical need that cannot be satisfied by the modification of stock conventional or orthopedic shoes, custom-made orthopedic shoes are covered, subject to utilization controls.
Therapeutic shoes and inserts are covered when provided to beneficiaries with a diagnosis of diabetes, subject to utilization controls, to the extent that federal financial participation is available.
(l)Hearing aids are covered, subject to utilization controls. Utilization controls shall allow replacement of hearing aids necessary because of loss or destruction due to circumstances beyond the beneficiarys control.
(m)Durable medical equipment and medical supplies are covered, subject to utilization controls. The utilization controls shall allow the replacement of durable medical equipment and medical supplies when necessary because of loss or destruction due to circumstances beyond the beneficiarys control. The utilization controls shall allow authorization of durable medical equipment needed to assist a disabled beneficiary in caring for a child for whom the disabled beneficiary is a parent, stepparent, foster parent, or legal guardian, subject to the availability of federal financial participation. The department shall adopt emergency regulations to define and establish criteria for assistive durable medical equipment in accordance with the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code).
(n)Family planning services are covered, subject to utilization controls. However, for Medi-Cal managed care plans, any utilization controls shall be subject to Section 1367.25 of the Health and Safety Code.
(o)Inpatient intensive rehabilitation hospital services, including respiratory rehabilitation services, in a general acute care hospital are covered, subject to utilization controls, when either of the following criteria are met:
(1)A patient with a permanent disability or severe impairment requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to develop function beyond the limited amount that would occur in the normal course of recovery.
(2)A patient with a chronic or progressive disease requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to maintain the patients present functional level as long as possible.
(p)(1)Adult day health care is covered in accordance with Chapter 8.7 (commencing with Section 14520).
(2)Commencing 30 days after the effective date of the act that added this paragraph, and notwithstanding the number of days previously approved through a treatment authorization request, adult day health care is covered for a maximum of three days per week.
(3)As provided in accordance with paragraph (4), adult day health care is covered for a maximum of five days per week.
(4)As of the date that the director makes the declaration described in subdivision (g) of Section 14525.1, paragraph (2) shall become inoperative and paragraph (3) shall become operative.
(q)(1)Application of fluoride, or other appropriate fluoride treatment as defined by the department, and other prophylaxis treatment for children 17 years of age and under are covered.
(2)All dental hygiene services provided by a registered dental hygienist, registered dental hygienist in extended functions, and registered dental hygienist in alternative practice licensed pursuant to Sections 1753, 1917, 1918, and 1922 of the Business and Professions Code may be covered as long as they are within the scope of Denti-Cal benefits and they are necessary services provided by a registered dental hygienist, registered dental hygienist in extended functions, or registered dental hygienist in alternative practice.
(r)(1)Paramedic services performed by a city, county, or special district, or pursuant to a contract with a city, county, or special district, and pursuant to a program established under former Article 3 (commencing with Section 1480) of Chapter 2.5 of Division 2 of the Health and Safety Code by a paramedic certified pursuant to that article, and consisting of defibrillation and those services specified in subdivision (3) of former Section 1482 of the article.
(2)All providers enrolled under this subdivision shall satisfy all applicable statutory and regulatory requirements for becoming a Medi-Cal provider.
(3)This subdivision shall be implemented only to the extent funding is available under Section 14106.6.
(s)In-home medical care services are covered when medically appropriate and subject to utilization controls, for beneficiaries who would otherwise require care for an extended period of time in an acute care hospital at a cost higher than in-home medical care services. The director shall have the authority under this section to contract with organizations qualified to provide in-home medical care services to those persons. These services may be provided to patients placed in shared or congregate living arrangements, if a home setting is not medically appropriate or available to the beneficiary. As used in this section, in-home medical care service includes utility bills directly attributable to continuous, 24-hour operation of life-sustaining medical equipment, to the extent that federal financial participation is available.
As used in this subdivision, in-home medical care services include, but are not limited to:
(1)Level-of-care and cost-of-care evaluations.
(2)Expenses, directly attributable to home care activities, for materials.
(3)Physician fees for home visits.
(4)Expenses directly attributable to home care activities for shelter and modification to shelter.
(5)Expenses directly attributable to additional costs of special diets, including tube feeding.
(6)Medically related personal services.
(7)Home nursing education.
(8)Emergency maintenance repair.
(9)Home health agency personnel benefits that permit coverage of care during periods when regular personnel are on vacation or using sick leave.
(10)All services needed to maintain antiseptic conditions at stoma or shunt sites on the body.
(11)Emergency and nonemergency medical transportation.
(12)Medical supplies.
(13)Medical equipment, including, but not limited to, scales, gurneys, and equipment racks suitable for paralyzed patients.
(14)Utility use directly attributable to the requirements of home care activities that are in addition to normal utility use.
(15)Special drugs and medications.
(16)Home health agency supervision of visiting staff that is medically necessary, but not included in the home health agency rate.
(17)Therapy services.
(18)Household appliances and household utensil costs directly attributable to home care activities.
(19)Modification of medical equipment for home use.
(20)Training and orientation for use of life-support systems, including, but not limited to, support of respiratory functions.
(21)Respiratory care practitioner services as defined in Sections 3702 and 3703 of the Business and Professions Code, subject to prescription by a physician and surgeon.
Beneficiaries receiving in-home medical care services are entitled to the full range of services within the Medi-Cal scope of benefits as defined by this section, subject to medical necessity and applicable utilization control. Services provided pursuant to this subdivision, which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with a home- and community-based services waiver.
(t)Home- and community-based services approved by the United States Department of Health and Human Services are covered to the extent that federal financial participation is available for those services under the state plan or waivers granted in accordance with Section 1315 or 1396n of Title 42 of the United States Code. The director may seek waivers for any or all home- and community-based services approvable under Section 1315 or 1396n of Title 42 of the United States Code. Coverage for those services shall be limited by the terms, conditions, and duration of the federal waivers.
(u)Comprehensive perinatal services, as provided through an agreement with a health care provider designated in Section 14134.5 and meeting the standards developed by the department pursuant to Section 14134.5, subject to utilization controls.
The department shall seek any federal waivers necessary to implement the provisions of this subdivision. The provisions for which appropriate federal waivers cannot be obtained shall not be implemented. Provisions for which waivers are obtained or for which waivers are not required shall be implemented notwithstanding any inability to obtain federal waivers for the other provisions. No provision of this subdivision shall be implemented unless matching funds from Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code are available.
(v)Early and periodic screening, diagnosis, and treatment for any individual under 21 years of age is covered, consistent with the requirements of Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code.
(w)Hospice service which is Medicare-certified hospice service is covered, subject to utilization controls. Coverage shall be available only to the extent that no additional net program costs are incurred.
(x)When a claim for treatment provided to a beneficiary includes both services that are authorized and reimbursable under this chapter, and services that are not reimbursable under this chapter, that portion of the claim for the treatment and services authorized and reimbursable under this chapter shall be payable.
(y)Home- and community-based services approved by the United States Department of Health and Human Services for beneficiaries with a diagnosis of AIDS or ARC, who require intermediate care or a higher level of care.
Services provided pursuant to a waiver obtained from the Secretary of the United States Department of Health and Human Services pursuant to this subdivision, and which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with the waiver, and subject to the terms, conditions, and duration of the waiver. These services shall be provided to individual beneficiaries in accordance with the clients needs as identified in the plan of care, and subject to medical necessity and applicable utilization control.
The director may under this section contract with organizations qualified to provide, directly or by subcontract, services provided for in this subdivision to eligible beneficiaries. Contracts or agreements entered into pursuant to this division shall not be subject to the Public Contract Code.
(z)Respiratory care when provided in organized health care systems as defined in Section 3701 of the Business and Professions Code, and as an in-home medical service as outlined in subdivision (s).
(aa)(1)There is hereby established in the department, a program to provide comprehensive clinical family planning services to any person who has a family income at or below 200 percent of the federal poverty level, as revised annually, and who is eligible to receive these services pursuant to the waiver identified in paragraph (2). This program shall be known as the Family Planning, Access, Care, and Treatment (Family PACT) Program.
(2)The department shall seek a waiver in accordance with Section 1315 of Title 42 of the United States Code, or a state plan amendment adopted in accordance with Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code, which was added to Section 1396a of Title 42 of the United States Code by Section 2303(a)(2) of the federal Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), for a program to provide comprehensive clinical family planning services as described in paragraph (8). Under the waiver, the program shall be operated only in accordance with the waiver and the statutes and regulations in paragraph (4) and subject to the terms, conditions, and duration of the waiver. Under the state plan amendment, which shall replace the waiver and shall be known as the Family PACT successor state plan amendment, the program shall be operated only in accordance with this subdivision and the statutes and regulations in paragraph (4). The state shall use the standards and processes imposed by the state on January 1, 2007, including the application of an eligibility discount factor to the extent required by the federal Centers for Medicare and Medicaid Services, for purposes of determining eligibility as permitted under Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code. To the extent that federal financial participation is available, the program shall continue to conduct education, outreach, enrollment, service delivery, and evaluation services as specified under the waiver. The services shall be provided under the program only if the waiver and, when applicable, the successor state plan amendment are approved by the federal Centers for Medicare and Medicaid Services and only to the extent that federal financial participation is available for the services. Nothing in this section shall prohibit the department from seeking the Family PACT successor state plan amendment during the operation of the waiver.
(3)Solely for the purposes of the waiver or Family PACT successor state plan amendment and notwithstanding any other law, the collection and use of an individuals social security number shall be necessary only to the extent required by federal law.
(4)Sections 14105.3 to 14105.39, inclusive, 14107.11, 24005, and 24013, and any regulations adopted under these statutes shall apply to the program provided for under this subdivision. No other provision of law under the Medi-Cal program or the State-Only Family Planning Program shall apply to the program provided for under this subdivision.
(5)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement, without taking regulatory action, the provisions of the waiver after its approval by the federal Centers for Medicare and Medicaid Services and the provisions of this section by means of an all-county letter or similar instruction to providers. Thereafter, the department shall adopt regulations to implement this section and the approved waiver in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Beginning six months after the effective date of the act adding this subdivision, the department shall provide a status report to the Legislature on a semiannual basis until regulations have been adopted.
(6)In the event that the Department of Finance determines that the program operated under the authority of the waiver described in paragraph (2) or the Family PACT successor state plan amendment is no longer cost effective, this subdivision shall become inoperative on the first day of the first month following the issuance of a 30-day notification of that determination in writing by the Department of Finance to the chairperson in each house that considers appropriations, the chairpersons of the committees, and the appropriate subcommittees in each house that considers the State Budget, and the Chairperson of the Joint Legislative Budget Committee.
(7)If this subdivision ceases to be operative, all persons who have received or are eligible to receive comprehensive clinical family planning services pursuant to the waiver described in paragraph (2) shall receive family planning services under the Medi-Cal program pursuant to subdivision (n) if they are otherwise eligible for Medi-Cal with no share of cost, or shall receive comprehensive clinical family planning services under the program established in Division 24 (commencing with Section 24000) either if they are eligible for Medi-Cal with a share of cost or if they are otherwise eligible under Section 24003.
(8)For purposes of this subdivision, comprehensive clinical family planning services means the process of establishing objectives for the number and spacing of children, and selecting the means by which those objectives may be achieved. These means include a broad range of acceptable and effective methods and services to limit or enhance fertility, including contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, natural family planning, abstinence methods, and basic, limited fertility management. Comprehensive clinical family planning services include, but are not limited to, preconception counseling, maternal and fetal health counseling, general reproductive health care, including diagnosis and treatment of infections and conditions, including cancer, that threaten reproductive capability, medical family planning treatment and procedures, including supplies and followup, and informational, counseling, and educational services. Comprehensive clinical family planning services shall not include abortion, pregnancy testing solely for the purposes of referral for abortion or services ancillary to abortions, or pregnancy care that is not incident to the diagnosis of pregnancy. Comprehensive clinical family planning services shall be subject to utilization control and include all of the following:
(A)Family planning related services and male and female sterilization. Family planning services for men and women shall include emergency services and services for complications directly related to the contraceptive method, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, and followup, consultation, and referral services, as indicated, which may require treatment authorization requests.
(B)All United States Department of Agriculture, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies that are in keeping with current standards of practice and from which the individual may choose.
(C)Culturally and linguistically appropriate health education and counseling services, including informed consent, that include all of the following:
(i)Psychosocial and medical aspects of contraception.
(ii)Sexuality.
(iii)Fertility.
(iv)Pregnancy.
(v)Parenthood.
(vi)Infertility.
(vii)Reproductive health care.
(viii)Preconception and nutrition counseling.
(ix)Prevention and treatment of sexually transmitted infection.
(x)Use of contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies.
(xi)Possible contraceptive consequences and followup.
(xii)Interpersonal communication and negotiation of relationships to assist individuals and couples in effective contraceptive method use and planning families.
(D)A comprehensive health history, updated at the next periodic visit (between 11 and 24 months after initial examination) that includes a complete obstetrical history, gynecological history, contraceptive history, personal medical history, health risk factors, and family health history, including genetic or hereditary conditions.
(E)A complete physical examination on initial and subsequent periodic visits.
(F)Services, drugs, devices, and supplies deemed by the federal Centers for Medicare and Medicaid Services to be appropriate for inclusion in the program.
(9)In order to maximize the availability of federal financial participation under this subdivision, the director shall have the discretion to implement the Family PACT successor state plan amendment retroactively to July 1, 2010.
(ab)(1)Purchase of prescribed enteral nutrition products is covered, subject to the Medi-Cal list of enteral nutrition products and utilization controls.
(2)Purchase of enteral nutrition products is limited to those products to be administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube. Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from this paragraph.
(3)Notwithstanding paragraph (2), the department may deem an enteral nutrition product, not administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube, a benefit for patients with diagnoses, including, but not limited to, malabsorption and inborn errors of metabolism, if the product has been shown to be neither investigational nor experimental when used as part of a therapeutic regimen to prevent serious disability or death.
(4)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement the amendments to this subdivision made by the act that added this paragraph by means of all-county letters, provider bulletins, or similar instructions, without taking regulatory action.
(5)The amendments made to this subdivision by the act that added this paragraph shall be implemented June 1, 2011, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(ac)Diabetic testing supplies are covered when provided by a pharmacy, subject to utilization controls.
(ad)(1)Nonmedical transportation is covered, subject to utilization controls and permissible time and distance standards, for a beneficiary to obtain covered Medi-Cal services.
(2)(A)(i)Nonmedical transportation includes, at a minimum, round trip transportation for a beneficiary to obtain covered Medi-Cal services by passenger car, taxicab, or any other form of public or private conveyance, and mileage reimbursement when conveyance is in a private vehicle arranged by the beneficiary and not through a transportation broker, bus passes, taxi vouchers, or train tickets.
(ii)Nonmedical transportation does not include the transportation of sick, injured, invalid, convalescent, infirm, or otherwise incapacitated beneficiaries by ambulances, litter vans, or wheelchair vans licensed, operated, and equipped in accordance with state and local statutes, ordinances, or regulations.
(B)Nonmedical transportation shall be provided for a beneficiary who can attest in a manner to be specified by the department that other currently available resources have been reasonably exhausted. For beneficiaries enrolled in a managed care plan, nonmedical transportation shall be provided by the beneficiarys managed care plan. For Medi-Cal fee-for-service beneficiaries, the department shall provide nonmedical transportation when those services are not available to the beneficiary under Sections 14132.44 and 14132.47.
(3)Nonmedical transportation shall be provided in a form and manner that is accessible, in terms of physical and geographic accessibility, for the beneficiary and consistent with applicable state and federal disability rights laws.
(4)It is the intent of the Legislature in enacting this subdivision to affirm the requirement under Section 431.53 of Title 42 of the Code of Federal Regulations, in which the department is required to provide necessary transportation, including nonmedical transportation, for recipients to and from covered services. This subdivision shall not be interpreted to add a new benefit to the Medi-Cal program.
(5)The department shall seek any federal approvals that may be required to implement this subdivision, including, but not limited to, approval of revisions to the existing state plan that the department determines are necessary to implement this subdivision.
(6)This subdivision shall be implemented only to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained.
(7)Prior to the effective date of any necessary federal approvals, nonmedical transportation was not a Medi-Cal managed care benefit with the exception of when provided as an Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) service.
(8)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department, without taking any further regulatory action, shall implement, interpret, or make specific this subdivision by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions until the time regulations are adopted. By July 1, 2018, the department shall adopt regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Commencing January 1, 2018, and notwithstanding Section 10231.5 of the Government Code, the department shall provide a status report to the Legislature on a semiannual basis, in compliance with Section 9795 of the Government Code, until regulations have been adopted.
(9)This subdivision shall not be implemented until July 1, 2017.
(ae)(1)Continuous glucose monitors and related supplies required for use with those monitors are covered for the treatment of diabetes mellitus type 1 when medically necessary and when all of the following criteria are satisfied: necessary, subject to utilization controls.
(A)The beneficiary is insulin-treated with multiple daily injections of insulin or a continuous subcutaneous insulin infusion pump.(B)The beneficiarys insulin treatment regimen requires frequent adjustment.(2)Continuous glucose monitors and related supplies required for use with those monitors are covered for treatment of diabetes mellitus type 2 when medically necessary and when all of the following criteria are satisfied:(A)The beneficiary is insulin-treated with multiple daily injections of insulin or a continuous subcutaneous insulin infusion with hypoglycemia unawareness.(B)The beneficiary has been using a home blood glucose monitor and performing frequent blood glucose monitor testing four or more times per day.(C)The beneficiarys insulin treatment regimen requires frequent adjustment. (3)(2)This subdivision shall be implemented only to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
The following is the schedule of benefits under this chapter:
(a)Outpatient services are covered as follows:
Physician, hospital or clinic outpatient, surgical center, respiratory care, optometric, chiropractic, psychology, podiatric, occupational therapy, physical therapy, speech therapy, audiology, acupuncture to the extent federal matching funds are provided for acupuncture, and services of persons rendering treatment by prayer or healing by spiritual means in the practice of any church or religious denomination insofar as these can be encompassed by federal participation under an approved plan, subject to utilization controls.
(b)(1)Inpatient hospital services, including, but not limited to, physician and podiatric services, physical therapy therapy, and occupational therapy, are covered subject to utilization controls.
(2)For Medi-Cal fee-for-service beneficiaries, emergency services and care that are necessary for the treatment of an emergency medical condition and medical care directly related to the emergency medical condition. This paragraph shall not be construed to change the obligation of Medi-Cal managed care plans to provide emergency services and care. For the purposes of this paragraph, emergency services and care and emergency medical condition shall have the same meanings as those terms are defined in Section 1317.1 of the Health and Safety Code.
(c)Nursing facility services, subacute care services, and services provided by any category of intermediate care facility for the developmentally disabled, including podiatry, physician, nurse practitioner services, and prescribed drugs, as described in subdivision (d), are covered subject to utilization controls. Respiratory care, physical therapy, occupational therapy, speech therapy, and audiology services for patients in nursing facilities and any category of intermediate care facility for the developmentally disabled are covered subject to utilization controls.
(d)(1)Purchase of prescribed drugs is covered subject to the Medi-Cal List of Contract Drugs and utilization controls.
(2)Purchase of drugs used to treat erectile dysfunction or any off-label uses of those drugs are covered only to the extent that federal financial participation is available.
(3)(A)To the extent required by federal law, the purchase of outpatient prescribed drugs, for which the prescription is executed by a prescriber in written, nonelectronic form on or after April 1, 2008, is covered only when executed on a tamper resistant prescription form. The implementation of this paragraph shall conform to the guidance issued by the federal Centers for Medicare and Medicaid Services but shall not conflict with state statutes on the characteristics of tamper resistant prescriptions for controlled substances, including Section 11162.1 of the Health and Safety Code. The department shall provide providers and beneficiaries with as much flexibility in implementing these rules as allowed by the federal government. The department shall notify and consult with appropriate stakeholders in implementing, interpreting, or making specific this paragraph.
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instructions without taking regulatory action.
(4)(A)(i)For the purposes of this paragraph, nonlegend has the same meaning as defined in subdivision (a) of Section 14105.45.
(ii)Nonlegend acetaminophen-containing products, with the exception of childrens acetaminophen-containing products, selected by the department are not covered benefits.
(iii)Nonlegend cough and cold products selected by the department are not covered benefits. This clause shall be implemented on the first day of the first calendar month following 90 days after the effective date of the act that added this clause, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(iv)Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from clauses (ii) and (iii).
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instruction without taking regulatory action.
(e)Outpatient dialysis services and home hemodialysis services, including physician services, medical supplies, drugs, and equipment required for dialysis, are covered, subject to utilization controls.
(f)Anesthesiologist services when provided as part of an outpatient medical procedure, nurse anesthetist services when rendered in an inpatient or outpatient setting under conditions set forth by the director, outpatient laboratory services, and X-ray services are covered, subject to utilization controls. Nothing in this subdivision shall be construed to require prior authorization for anesthesiologist services provided as part of an outpatient medical procedure or for portable X-ray services in a nursing facility or any category of intermediate care facility for the developmentally disabled.
(g)Blood and blood derivatives are covered.
(h)(1)Emergency and essential diagnostic and restorative dental services, except for orthodontic, fixed bridgework, and partial dentures that are not necessary for balance of a complete artificial denture, are covered, subject to utilization controls. The utilization controls shall allow emergency and essential diagnostic and restorative dental services and prostheses that are necessary to prevent a significant disability or to replace previously furnished prostheses that are lost or destroyed due to circumstances beyond the beneficiarys control. Notwithstanding the foregoing, the director may by regulation provide for certain fixed artificial dentures necessary for obtaining employment or for medical conditions that preclude the use of removable dental prostheses, and for orthodontic services in cleft palate deformities administered by the departments California Children Services Program.
(2)For persons 21 years of age or older, the services specified in paragraph (1) shall be provided subject to the following conditions:
(A)Periodontal treatment is not a benefit.
(B)Endodontic therapy is not a benefit except for vital pulpotomy.
(C)Laboratory processed crowns are not a benefit.
(D)Removable prosthetics shall be a benefit only for patients as a requirement for employment.
(E)The director may, by regulation, provide for the provision of fixed artificial dentures that are necessary for medical conditions that preclude the use of removable dental prostheses.
(F)Notwithstanding the conditions specified in subparagraphs (A) to (E), inclusive, the department may approve services for persons with special medical disorders subject to utilization review.
(3)Paragraph (2) shall become inoperative July 1, 1995.
(i)Medical transportation is covered, subject to utilization controls.
(j)Home health care services are covered, subject to utilization controls.
(k)Prosthetic and orthotic devices and eyeglasses are covered, subject to utilization controls. Utilization controls shall allow replacement of prosthetic and orthotic devices and eyeglasses necessary because of loss or destruction due to circumstances beyond the beneficiarys control. Frame styles for eyeglasses replaced pursuant to this subdivision shall not change more than once every two years, unless the department so directs.
Orthopedic and conventional shoes are covered when provided by a prosthetic and orthotic supplier on the prescription of a physician and when at least one of the shoes will be attached to a prosthesis or brace, subject to utilization controls. Modification of stock conventional or orthopedic shoes when medically indicated, is covered subject to utilization controls. When there is a clearly established medical need that cannot be satisfied by the modification of stock conventional or orthopedic shoes, custom-made orthopedic shoes are covered, subject to utilization controls.
Therapeutic shoes and inserts are covered when provided to beneficiaries with a diagnosis of diabetes, subject to utilization controls, to the extent that federal financial participation is available.
(l)Hearing aids are covered, subject to utilization controls. Utilization controls shall allow replacement of hearing aids necessary because of loss or destruction due to circumstances beyond the beneficiarys control.
(m)Durable medical equipment and medical supplies are covered, subject to utilization controls. The utilization controls shall allow the replacement of durable medical equipment and medical supplies when necessary because of loss or destruction due to circumstances beyond the beneficiarys control. The utilization controls shall allow authorization of durable medical equipment needed to assist a disabled beneficiary in caring for a child for whom the disabled beneficiary is a parent, stepparent, foster parent, or legal guardian, subject to the availability of federal financial participation. The department shall adopt emergency regulations to define and establish criteria for assistive durable medical equipment in accordance with the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code).
(n)Family planning services are covered, subject to utilization controls. However, for Medi-Cal managed care plans, any utilization controls shall be subject to Section 1367.25 of the Health and Safety Code.
(o)Inpatient intensive rehabilitation hospital services, including respiratory rehabilitation services, in a general acute care hospital are covered, subject to utilization controls, when either of the following criteria are met:
(1)A patient with a permanent disability or severe impairment requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to develop function beyond the limited amount that would occur in the normal course of recovery.
(2)A patient with a chronic or progressive disease requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to maintain the patients present functional level as long as possible.
(p)(1)Adult day health care is covered in accordance with Chapter 8.7 (commencing with Section 14520).
(2)Commencing 30 days after the effective date of the act that added this paragraph, and notwithstanding the number of days previously approved through a treatment authorization request, adult day health care is covered for a maximum of three days per week.
(3)As provided in accordance with paragraph (4), adult day health care is covered for a maximum of five days per week.
(4)As of the date that the director makes the declaration described in subdivision (g) of Section 14525.1, paragraph (2) shall become inoperative and paragraph (3) shall become operative.
(q)(1)Application of fluoride, or other appropriate fluoride treatment as defined by the department, and other prophylaxis treatment for children 17 years of age and under are covered.
(2)All dental hygiene services provided by a registered dental hygienist, registered dental hygienist in extended functions, and registered dental hygienist in alternative practice licensed pursuant to Sections 1753, 1917, 1918, and 1922 of the Business and Professions Code may be covered as long as they are within the scope of Denti-Cal benefits and they are necessary services provided by a registered dental hygienist, registered dental hygienist in extended functions, or registered dental hygienist in alternative practice.
(r)(1)Paramedic services performed by a city, county, or special district, or pursuant to a contract with a city, county, or special district, and pursuant to a program established under former Article 3 (commencing with Section 1480) of Chapter 2.5 of Division 2 of the Health and Safety Code by a paramedic certified pursuant to that article, and consisting of defibrillation and those services specified in subdivision (3) of former Section 1482 of the article.
(2)All providers enrolled under this subdivision shall satisfy all applicable statutory and regulatory requirements for becoming a Medi-Cal provider.
(3)This subdivision shall be implemented only to the extent funding is available under Section 14106.6.
(s)In-home medical care services are covered when medically appropriate and subject to utilization controls, for beneficiaries who would otherwise require care for an extended period of time in an acute care hospital at a cost higher than in-home medical care services. The director shall have the authority under this section to contract with organizations qualified to provide in-home medical care services to those persons. These services may be provided to patients placed in shared or congregate living arrangements, if a home setting is not medically appropriate or available to the beneficiary. As used in this section, in-home medical care service includes utility bills directly attributable to continuous, 24-hour operation of life-sustaining medical equipment, to the extent that federal financial participation is available.
As used in this subdivision, in-home medical care services include, but are not limited to:
(1)Level-of-care and cost-of-care evaluations.
(2)Expenses, directly attributable to home care activities, for materials.
(3)Physician fees for home visits.
(4)Expenses directly attributable to home care activities for shelter and modification to shelter.
(5)Expenses directly attributable to additional costs of special diets, including tube feeding.
(6)Medically related personal services.
(7)Home nursing education.
(8)Emergency maintenance repair.
(9)Home health agency personnel benefits that permit coverage of care during periods when regular personnel are on vacation or using sick leave.
(10)All services needed to maintain antiseptic conditions at stoma or shunt sites on the body.
(11)Emergency and nonemergency medical transportation.
(12)Medical supplies.
(13)Medical equipment, including, but not limited to, scales, gurneys, and equipment racks suitable for paralyzed patients.
(14)Utility use directly attributable to the requirements of home care activities that are in addition to normal utility use.
(15)Special drugs and medications.
(16)Home health agency supervision of visiting staff that is medically necessary, but not included in the home health agency rate.
(17)Therapy services.
(18)Household appliances and household utensil costs directly attributable to home care activities.
(19)Modification of medical equipment for home use.
(20)Training and orientation for use of life-support systems, including, but not limited to, support of respiratory functions.
(21)Respiratory care practitioner services as defined in Sections 3702 and 3703 of the Business and Professions Code, subject to prescription by a physician and surgeon.
Beneficiaries receiving in-home medical care services are entitled to the full range of services within the Medi-Cal scope of benefits as defined by this section, subject to medical necessity and applicable utilization control. Services provided pursuant to this subdivision, which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with a home- and community-based services waiver.
(t)Home- and community-based services approved by the United States Department of Health and Human Services are covered to the extent that federal financial participation is available for those services under the state plan or waivers granted in accordance with Section 1315 or 1396n of Title 42 of the United States Code. The director may seek waivers for any or all home- and community-based services approvable under Section 1315 or 1396n of Title 42 of the United States Code. Coverage for those services shall be limited by the terms, conditions, and duration of the federal waivers.
(u)Comprehensive perinatal services, as provided through an agreement with a health care provider designated in Section 14134.5 and meeting the standards developed by the department pursuant to Section 14134.5, subject to utilization controls.
The department shall seek any federal waivers necessary to implement the provisions of this subdivision. The provisions for which appropriate federal waivers cannot be obtained shall not be implemented. Provisions for which waivers are obtained or for which waivers are not required shall be implemented notwithstanding any inability to obtain federal waivers for the other provisions. No provision of this subdivision shall be implemented unless matching funds from Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code are available.
(v)Early and periodic screening, diagnosis, and treatment for any individual under 21 years of age is covered, consistent with the requirements of Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code.
(w)Hospice service which is Medicare-certified hospice service is covered, subject to utilization controls. Coverage shall be available only to the extent that no additional net program costs are incurred.
(x)When a claim for treatment provided to a beneficiary includes both services that are authorized and reimbursable under this chapter, and services that are not reimbursable under this chapter chapter, that portion of the claim for the treatment and services authorized and reimbursable under this chapter shall be payable.
(y)Home- and community-based services approved by the United States Department of Health and Human Services for beneficiaries with a diagnosis of AIDS or ARC, who require intermediate care or a higher level of care.
Services provided pursuant to a waiver obtained from the Secretary of the United States Department of Health and Human Services pursuant to this subdivision, and which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with the waiver, and subject to the terms, conditions, and duration of the waiver. These services shall be provided to individual beneficiaries in accordance with the clients needs as identified in the plan of care, and subject to medical necessity and applicable utilization control.
The director may under this section contract with organizations qualified to provide, directly or by subcontract, services provided for in this subdivision to eligible beneficiaries. Contracts or agreements entered into pursuant to this division shall not be subject to the Public Contract Code.
(z)Respiratory care when provided in organized health care systems as defined in Section 3701 of the Business and Professions Code, and as an in-home medical service as outlined in subdivision (s).
(aa)(1)There is hereby established in the department, a program to provide comprehensive clinical family planning services to any person who has a family income at or below 200 percent of the federal poverty level, as revised annually, and who is eligible to receive these services pursuant to the waiver identified in paragraph (2). This program shall be known as the Family Planning, Access, Care, and Treatment (Family PACT) Program.
(2)The department shall seek a waiver in accordance with Section 1315 of Title 42 of the United States Code, or a state plan amendment adopted in accordance with Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code, which was added to Section 1396a of Title 42 of the United States Code by Section 2303(a)(2) of the federal Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), for a program to provide comprehensive clinical family planning services as described in paragraph (8). Under the waiver, the program shall be operated only in accordance with the waiver and the statutes and regulations in paragraph (4) and subject to the terms, conditions, and duration of the waiver. Under the state plan amendment, which shall replace the waiver and shall be known as the Family PACT successor state plan amendment, the program shall be operated only in accordance with this subdivision and the statutes and regulations in paragraph (4). The state shall use the standards and processes imposed by the state on January 1, 2007, including the application of an eligibility discount factor to the extent required by the federal Centers for Medicare and Medicaid Services, for purposes of determining eligibility as permitted under Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code. To the extent that federal financial participation is available, the program shall continue to conduct education, outreach, enrollment, service delivery, and evaluation services as specified under the waiver. The services shall be provided under the program only if the waiver and, when applicable, the successor state plan amendment are approved by the federal Centers for Medicare and Medicaid Services and only to the extent that federal financial participation is available for the services. Nothing in this section shall prohibit the department from seeking the Family PACT successor state plan amendment during the operation of the waiver.
(3)Solely for the purposes of the waiver or Family PACT successor state plan amendment and notwithstanding any other law, the collection and use of an individuals social security number shall be necessary only to the extent required by federal law.
(4)Sections 14105.3 to 14105.39, inclusive, 14107.11, 24005, and 24013, and any regulations adopted under these statutes shall apply to the program provided for under this subdivision. No other provision of law under the Medi-Cal program or the State-Only Family Planning Program shall apply to the program provided for under this subdivision.
(5)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement, without taking regulatory action, the provisions of the waiver after its approval by the federal Centers for Medicare and Medicaid Services and the provisions of this section by means of an all-county letter or similar instruction to providers. Thereafter, the department shall adopt regulations to implement this section and the approved waiver in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Beginning six months after the effective date of the act adding this subdivision, the department shall provide a status report to the Legislature on a semiannual basis until regulations have been adopted.
(6)In the event that the Department of Finance determines that the program operated under the authority of the waiver described in paragraph (2) or the Family PACT successor state plan amendment is no longer cost effective, this subdivision shall become inoperative on the first day of the first month following the issuance of a 30-day notification of that determination in writing by the Department of Finance to the chairperson in each house that considers appropriations, the chairpersons of the committees, and the appropriate subcommittees in each house that considers the State Budget, and the Chairperson of the Joint Legislative Budget Committee.
(7)If this subdivision ceases to be operative, all persons who have received or are eligible to receive comprehensive clinical family planning services pursuant to the waiver described in paragraph (2) shall receive family planning services under the Medi-Cal program pursuant to subdivision (n) if they are otherwise eligible for Medi-Cal with no share of cost, or shall receive comprehensive clinical family planning services under the program established in Division 24 (commencing with Section 24000) either if they are eligible for Medi-Cal with a share of cost or if they are otherwise eligible under Section 24003.
(8)For purposes of this subdivision, comprehensive clinical family planning services means the process of establishing objectives for the number and spacing of children, and selecting the means by which those objectives may be achieved. These means include a broad range of acceptable and effective methods and services to limit or enhance fertility, including contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, natural family planning, abstinence methods, and basic, limited fertility management. Comprehensive clinical family planning services include, but are not limited to, preconception counseling, maternal and fetal health counseling, general reproductive health care, including diagnosis and treatment of infections and conditions, including cancer, that threaten reproductive capability, medical family planning treatment and procedures, including supplies and followup, and informational, counseling, and educational services. Comprehensive clinical family planning services shall not include abortion, pregnancy testing solely for the purposes of referral for abortion or services ancillary to abortions, or pregnancy care that is not incident to the diagnosis of pregnancy. Comprehensive clinical family planning services shall be subject to utilization control and include all of the following:
(A)Family planning related services and male and female sterilization. Family planning services for men and women shall include emergency services and services for complications directly related to the contraceptive method, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, and followup, consultation, and referral services, as indicated, which may require treatment authorization requests.
(B)All United States Department of Agriculture, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies that are in keeping with current standards of practice and from which the individual may choose.
(C)Culturally and linguistically appropriate health education and counseling services, including informed consent, that include all of the following:
(i)Psychosocial and medical aspects of contraception.
(ii)Sexuality.
(iii)Fertility.
(iv)Pregnancy.
(v)Parenthood.
(vi)Infertility.
(vii)Reproductive health care.
(viii)Preconception and nutrition counseling.
(ix)Prevention and treatment of sexually transmitted infection.
(x)Use of contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies.
(xi)Possible contraceptive consequences and followup.
(xii)Interpersonal communication and negotiation of relationships to assist individuals and couples in effective contraceptive method use and planning families.
(D)A comprehensive health history, updated at the next periodic visit (between 11 and 24 months after initial examination) that includes a complete obstetrical history, gynecological history, contraceptive history, personal medical history, health risk factors, and family health history, including genetic or hereditary conditions.
(E)A complete physical examination on initial and subsequent periodic visits.
(F)Services, drugs, devices, and supplies deemed by the federal Centers for Medicare and Medicaid Services to be appropriate for inclusion in the program.
(9)In order to maximize the availability of federal financial participation under this subdivision, the director shall have the discretion to implement the Family PACT successor state plan amendment retroactively to July 1, 2010.
(ab)(1)Purchase of prescribed enteral nutrition products is covered, subject to the Medi-Cal list of enteral nutrition products and utilization controls.
(2)Purchase of enteral nutrition products is limited to those products to be administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube. Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from this paragraph.
(3)Notwithstanding paragraph (2), the department may deem an enteral nutrition product, not administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube, a benefit for patients with diagnoses, including, but not limited to, malabsorption and inborn errors of metabolism, if the product has been shown to be neither investigational nor experimental when used as part of a therapeutic regimen to prevent serious disability or death.
(4)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement the amendments to this subdivision made by the act that added this paragraph by means of all-county letters, provider bulletins, or similar instructions, without taking regulatory action.
(5)The amendments made to this subdivision by the act that added this paragraph shall be implemented June 1, 2011, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(ac)Diabetic testing supplies are covered when provided by a pharmacy, subject to utilization controls.
(ad)(1)Nonmedical transportation is covered, subject to utilization controls and permissible time and distance standards, for a beneficiary to obtain covered Medi-Cal services.
(2)(A)(i)Nonmedical transportation includes, at a minimum, round trip transportation for a beneficiary to obtain covered Medi-Cal services by passenger car, taxicab, or any other form of public or private conveyance, and mileage reimbursement when conveyance is in a private vehicle arranged by the beneficiary and not through a transportation broker, bus passes, taxi vouchers, or train tickets.
(ii)Nonmedical transportation does not include the transportation of sick, injured, invalid, convalescent, infirm, or otherwise incapacitated beneficiaries by ambulances, litter vans, or wheelchair vans licensed, operated, and equipped in accordance with state and local statutes, ordinances, or regulations.
(B)Nonmedical transportation shall be provided for a beneficiary who can attest in a manner to be specified by the department that other currently available resources have been reasonably exhausted. For beneficiaries enrolled in a managed care plan, nonmedical transportation shall be provided by the beneficiarys managed care plan. For Medi-Cal fee-for-service beneficiaries, the department shall provide nonmedical transportation when those services are not available to the beneficiary under Sections 14132.44 and 14132.47.
(3)Nonmedical transportation shall be provided in a form and manner that is accessible, in terms of physical and geographic accessibility, for the beneficiary and consistent with applicable state and federal disability rights laws.
(4)It is the intent of the Legislature in enacting this subdivision to affirm the requirement under Section 431.53 of Title 42 of the Code of Federal Regulations, in which the department is required to provide necessary transportation, including nonmedical transportation, for recipients to and from covered services. This subdivision shall not be interpreted to add a new benefit to the Medi-Cal program.
(5)The department shall seek any federal approvals that may be required to implement this subdivision, including, but not limited to, approval of revisions to the existing state plan that the department determines are necessary to implement this subdivision.
(6)This subdivision shall be implemented only to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained.
(7)Prior to the effective date of any necessary federal approvals, nonmedical transportation was not a Medi-Cal managed care benefit with the exception of when provided as an Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) service.
(8)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department, without taking any further regulatory action, shall implement, interpret, or make specific this subdivision by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions until the time regulations are adopted. By July 1, 2018, the department shall adopt regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Commencing January 1, 2018, and notwithstanding Section 10231.5 of the Government Code, the department shall provide a status report to the Legislature on a semiannual basis, in compliance with Section 9795 of the Government Code, until regulations have been adopted.
(9)This subdivision shall not be implemented until July 1, 2017.
(ae)(1)Continuous glucose monitors are covered when medically necessary for the management and treatment of type 1 diabetes, type 2 diabetes, and gestational diabetes. and related supplies required for use with those monitors are covered for the treatment of diabetes mellitus type 1 when medically necessary and when all of the following criteria are satisfied:
(A)The beneficiary is insulin-treated with multiple daily injections of insulin or a continuous subcutaneous insulin infusion pump.
(B)The beneficiarys insulin treatment regimen requires frequent adjustment.
(2)Continuous glucose monitors and related supplies required for use with those monitors are covered for treatment of diabetes mellitus type 2 when medically necessary and when all of the following criteria are satisfied:
(A)The beneficiary is insulin-treated with multiple daily injections of insulin or a continuous subcutaneous insulin infusion with hypoglycemia unawareness.
(B)The beneficiary has been using a home blood glucose monitor and performing frequent blood glucose monitor testing four or more times per day.
(C)The beneficiarys insulin treatment regimen requires frequent adjustment.
(2)(3)This subdivision shall be implemented only to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
The following is the schedule of benefits under this chapter:
(a)Outpatient services are covered as follows:
Physician, hospital or clinic outpatient, surgical center, respiratory care, optometric, chiropractic, psychology, podiatric, occupational therapy, physical therapy, speech therapy, audiology, acupuncture to the extent federal matching funds are provided for acupuncture, and services of persons rendering treatment by prayer or healing by spiritual means in the practice of any church or religious denomination insofar as these can be encompassed by federal participation under an approved plan, subject to utilization controls.
(b)(1)Inpatient hospital services, including, but not limited to, physician and podiatric services, physical therapy and occupational therapy, are covered subject to utilization controls.
(2)For Medi-Cal fee-for-service beneficiaries, emergency services and care that are necessary for the treatment of an emergency medical condition and medical care directly related to the emergency medical condition. This paragraph shall not be construed to change the obligation of Medi-Cal managed care plans to provide emergency services and care. For the purposes of this paragraph, emergency services and care and emergency medical condition shall have the same meanings as those terms are defined in Section 1317.1 of the Health and Safety Code.
(c)Nursing facility services, subacute care services, and services provided by any category of intermediate care facility for the developmentally disabled, including podiatry, physician, nurse practitioner services, and prescribed drugs, as described in subdivision (d), are covered subject to utilization controls. Respiratory care, physical therapy, occupational therapy, speech therapy, and audiology services for patients in nursing facilities and any category of intermediate care facility for the developmentally disabled are covered subject to utilization controls.
(d)(1)Purchase of prescribed drugs is covered subject to the Medi-Cal List of Contract Drugs and utilization controls.
(2)Purchase of drugs used to treat erectile dysfunction or any off-label uses of those drugs are covered only to the extent that federal financial participation is available.
(3)(A)To the extent required by federal law, the purchase of outpatient prescribed drugs, for which the prescription is executed by a prescriber in written, nonelectronic form on or after April 1, 2008, is covered only when executed on a tamper resistant prescription form. The implementation of this paragraph shall conform to the guidance issued by the federal Centers for Medicare and Medicaid Services but shall not conflict with state statutes on the characteristics of tamper resistant prescriptions for controlled substances, including Section 11162.1 of the Health and Safety Code. The department shall provide providers and beneficiaries with as much flexibility in implementing these rules as allowed by the federal government. The department shall notify and consult with appropriate stakeholders in implementing, interpreting, or making specific this paragraph.
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instructions without taking regulatory action.
(4)(A)(i)For the purposes of this paragraph, nonlegend has the same meaning as defined in subdivision (a) of Section 14105.45.
(ii)Nonlegend acetaminophen-containing products, with the exception of childrens acetaminophen-containing products, selected by the department are not covered benefits.
(iii)Nonlegend cough and cold products selected by the department are not covered benefits. This clause shall be implemented on the first day of the first calendar month following 90 days after the effective date of the act that added this clause, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(iv)Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from clauses (ii) and (iii).
(B)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may take the actions specified in subparagraph (A) by means of a provider bulletin or notice, policy letter, or other similar instruction without taking regulatory action.
(e)Outpatient dialysis services and home hemodialysis services, including physician services, medical supplies, drugs, and equipment required for dialysis, are covered, subject to utilization controls.
(f)Anesthesiologist services when provided as part of an outpatient medical procedure, nurse anesthetist services when rendered in an inpatient or outpatient setting under conditions set forth by the director, outpatient laboratory services, and X-ray services are covered, subject to utilization controls. Nothing in this subdivision shall be construed to require prior authorization for anesthesiologist services provided as part of an outpatient medical procedure or for portable X-ray services in a nursing facility or any category of intermediate care facility for the developmentally disabled.
(g)Blood and blood derivatives are covered.
(h)(1)Emergency and essential diagnostic and restorative dental services, except for orthodontic, fixed bridgework, and partial dentures that are not necessary for balance of a complete artificial denture, are covered, subject to utilization controls. The utilization controls shall allow emergency and essential diagnostic and restorative dental services and prostheses that are necessary to prevent a significant disability or to replace previously furnished prostheses that are lost or destroyed due to circumstances beyond the beneficiarys control. Notwithstanding the foregoing, the director may by regulation provide for certain fixed artificial dentures necessary for obtaining employment or for medical conditions that preclude the use of removable dental prostheses, and for orthodontic services in cleft palate deformities administered by the departments California Children Services Program.
(2)For persons 21 years of age or older, the services specified in paragraph (1) shall be provided subject to the following conditions:
(A)Periodontal treatment is not a benefit.
(B)Endodontic therapy is not a benefit except for vital pulpotomy.
(C)Laboratory processed crowns are not a benefit.
(D)Removable prosthetics shall be a benefit only for patients as a requirement for employment.
(E)The director may, by regulation, provide for the provision of fixed artificial dentures that are necessary for medical conditions that preclude the use of removable dental prostheses.
(F)Notwithstanding the conditions specified in subparagraphs (A) to (E), inclusive, the department may approve services for persons with special medical disorders subject to utilization review.
(3)Paragraph (2) shall become inoperative July 1, 1995.
(i)Medical transportation is covered, subject to utilization controls.
(j)Home health care services are covered, subject to utilization controls.
(k)Prosthetic and orthotic devices and eyeglasses are covered, subject to utilization controls. Utilization controls shall allow replacement of prosthetic and orthotic devices and eyeglasses necessary because of loss or destruction due to circumstances beyond the beneficiarys control. Frame styles for eyeglasses replaced pursuant to this subdivision shall not change more than once every two years, unless the department so directs.
Orthopedic and conventional shoes are covered when provided by a prosthetic and orthotic supplier on the prescription of a physician and when at least one of the shoes will be attached to a prosthesis or brace, subject to utilization controls. Modification of stock conventional or orthopedic shoes when medically indicated, is covered subject to utilization controls. When there is a clearly established medical need that cannot be satisfied by the modification of stock conventional or orthopedic shoes, custom-made orthopedic shoes are covered, subject to utilization controls.
Therapeutic shoes and inserts are covered when provided to beneficiaries with a diagnosis of diabetes, subject to utilization controls, to the extent that federal financial participation is available.
(l)Hearing aids are covered, subject to utilization controls. Utilization controls shall allow replacement of hearing aids necessary because of loss or destruction due to circumstances beyond the beneficiarys control.
(m)Durable medical equipment and medical supplies are covered, subject to utilization controls. The utilization controls shall allow the replacement of durable medical equipment and medical supplies when necessary because of loss or destruction due to circumstances beyond the beneficiarys control. The utilization controls shall allow authorization of durable medical equipment needed to assist a disabled beneficiary in caring for a child for whom the disabled beneficiary is a parent, stepparent, foster parent, or legal guardian, subject to the availability of federal financial participation. The department shall adopt emergency regulations to define and establish criteria for assistive durable medical equipment in accordance with the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code).
(n)Family planning services are covered, subject to utilization controls. However, for Medi-Cal managed care plans, any utilization controls shall be subject to Section 1367.25 of the Health and Safety Code.
(o)Inpatient intensive rehabilitation hospital services, including respiratory rehabilitation services, in a general acute care hospital are covered, subject to utilization controls, when either of the following criteria are met:
(1)A patient with a permanent disability or severe impairment requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to develop function beyond the limited amount that would occur in the normal course of recovery.
(2)A patient with a chronic or progressive disease requires an inpatient intensive rehabilitation hospital program as described in Section 14064 to maintain the patients present functional level as long as possible.
(p)(1)Adult day health care is covered in accordance with Chapter 8.7 (commencing with Section 14520).
(2)Commencing 30 days after the effective date of the act that added this paragraph, and notwithstanding the number of days previously approved through a treatment authorization request, adult day health care is covered for a maximum of three days per week.
(3)As provided in accordance with paragraph (4), adult day health care is covered for a maximum of five days per week.
(4)As of the date that the director makes the declaration described in subdivision (g) of Section 14525.1, paragraph (2) shall become inoperative and paragraph (3) shall become operative.
(q)(1)Application of fluoride, or other appropriate fluoride treatment as defined by the department, and other prophylaxis treatment for children 17 years of age and under are covered.
(2)All dental hygiene services provided by a registered dental hygienist, registered dental hygienist in extended functions, and registered dental hygienist in alternative practice licensed pursuant to Sections 1753, 1917, 1918, and 1922 of the Business and Professions Code may be covered as long as they are within the scope of Denti-Cal benefits and they are necessary services provided by a registered dental hygienist, registered dental hygienist in extended functions, or registered dental hygienist in alternative practice.
(r)(1)Paramedic services performed by a city, county, or special district, or pursuant to a contract with a city, county, or special district, and pursuant to a program established under former Article 3 (commencing with Section 1480) of Chapter 2.5 of Division 2 of the Health and Safety Code by a paramedic certified pursuant to that article, and consisting of defibrillation and those services specified in subdivision (3) of former Section 1482 of the article.
(2)All providers enrolled under this subdivision shall satisfy all applicable statutory and regulatory requirements for becoming a Medi-Cal provider.
(3)This subdivision shall be implemented only to the extent funding is available under Section 14106.6.
(s)In-home medical care services are covered when medically appropriate and subject to utilization controls, for beneficiaries who would otherwise require care for an extended period of time in an acute care hospital at a cost higher than in-home medical care services. The director shall have the authority under this section to contract with organizations qualified to provide in-home medical care services to those persons. These services may be provided to patients placed in shared or congregate living arrangements, if a home setting is not medically appropriate or available to the beneficiary. As used in this section, in-home medical care service includes utility bills directly attributable to continuous, 24-hour operation of life-sustaining medical equipment, to the extent that federal financial participation is available.
As used in this subdivision, in-home medical care services include, but are not limited to:
(1)Level-of-care and cost-of-care evaluations.
(2)Expenses, directly attributable to home care activities, for materials.
(3)Physician fees for home visits.
(4)Expenses directly attributable to home care activities for shelter and modification to shelter.
(5)Expenses directly attributable to additional costs of special diets, including tube feeding.
(6)Medically related personal services.
(7)Home nursing education.
(8)Emergency maintenance repair.
(9)Home health agency personnel benefits that permit coverage of care during periods when regular personnel are on vacation or using sick leave.
(10)All services needed to maintain antiseptic conditions at stoma or shunt sites on the body.
(11)Emergency and nonemergency medical transportation.
(12)Medical supplies.
(13)Medical equipment, including, but not limited to, scales, gurneys, and equipment racks suitable for paralyzed patients.
(14)Utility use directly attributable to the requirements of home care activities that are in addition to normal utility use.
(15)Special drugs and medications.
(16)Home health agency supervision of visiting staff that is medically necessary, but not included in the home health agency rate.
(17)Therapy services.
(18)Household appliances and household utensil costs directly attributable to home care activities.
(19)Modification of medical equipment for home use.
(20)Training and orientation for use of life-support systems, including, but not limited to, support of respiratory functions.
(21)Respiratory care practitioner services as defined in Sections 3702 and 3703 of the Business and Professions Code, subject to prescription by a physician and surgeon.
Beneficiaries receiving in-home medical care services are entitled to the full range of services within the Medi-Cal scope of benefits as defined by this section, subject to medical necessity and applicable utilization control. Services provided pursuant to this subdivision, which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with a home- and community-based services waiver.
(t)Home- and community-based services approved by the United States Department of Health and Human Services are covered to the extent that federal financial participation is available for those services under the state plan or waivers granted in accordance with Section 1315 or 1396n of Title 42 of the United States Code. The director may seek waivers for any or all home- and community-based services approvable under Section 1315 or 1396n of Title 42 of the United States Code. Coverage for those services shall be limited by the terms, conditions, and duration of the federal waivers.
(u)Comprehensive perinatal services, as provided through an agreement with a health care provider designated in Section 14134.5 and meeting the standards developed by the department pursuant to Section 14134.5, subject to utilization controls.
The department shall seek any federal waivers necessary to implement the provisions of this subdivision. The provisions for which appropriate federal waivers cannot be obtained shall not be implemented. Provisions for which waivers are obtained or for which waivers are not required shall be implemented notwithstanding any inability to obtain federal waivers for the other provisions. No provision of this subdivision shall be implemented unless matching funds from Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code are available.
(v)Early and periodic screening, diagnosis, and treatment for any individual under 21 years of age is covered, consistent with the requirements of Subchapter XIX (commencing with Section 1396) of Chapter 7 of Title 42 of the United States Code.
(w)Hospice service which is Medicare-certified hospice service is covered, subject to utilization controls. Coverage shall be available only to the extent that no additional net program costs are incurred.
(x)When a claim for treatment provided to a beneficiary includes both services that are authorized and reimbursable under this chapter, and services that are not reimbursable under this chapter that portion of the claim for the treatment and services authorized and reimbursable under this chapter shall be payable.
(y)Home- and community-based services approved by the United States Department of Health and Human Services for beneficiaries with a diagnosis of AIDS or ARC, who require intermediate care or a higher level of care.
Services provided pursuant to a waiver obtained from the Secretary of the United States Department of Health and Human Services pursuant to this subdivision, and which are not otherwise included in the Medi-Cal schedule of benefits, shall be available only to the extent that federal financial participation for these services is available in accordance with the waiver, and subject to the terms, conditions, and duration of the waiver. These services shall be provided to individual beneficiaries in accordance with the clients needs as identified in the plan of care, and subject to medical necessity and applicable utilization control.
The director may under this section contract with organizations qualified to provide, directly or by subcontract, services provided for in this subdivision to eligible beneficiaries. Contracts or agreements entered into pursuant to this division shall not be subject to the Public Contract Code.
(z)Respiratory care when provided in organized health care systems as defined in Section 3701 of the Business and Professions Code, and as an in-home medical service as outlined in subdivision (s).
(aa)(1)There is hereby established in the department, a program to provide comprehensive clinical family planning services to any person who has a family income at or below 200 percent of the federal poverty level, as revised annually, and who is eligible to receive these services pursuant to the waiver identified in paragraph (2). This program shall be known as the Family Planning, Access, Care, and Treatment (Family PACT) Program.
(2)The department shall seek a waiver in accordance with Section 1315 of Title 42 of the United States Code, or a state plan amendment adopted in accordance with Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code, which was added to Section 1396a of Title 42 of the United States Code by Section 2303(a)(2) of the federal Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), for a program to provide comprehensive clinical family planning services as described in paragraph (8). Under the waiver, the program shall be operated only in accordance with the waiver and the statutes and regulations in paragraph (4) and subject to the terms, conditions, and duration of the waiver. Under the state plan amendment, which shall replace the waiver and shall be known as the Family PACT successor state plan amendment, the program shall be operated only in accordance with this subdivision and the statutes and regulations in paragraph (4). The state shall use the standards and processes imposed by the state on January 1, 2007, including the application of an eligibility discount factor to the extent required by the federal Centers for Medicare and Medicaid Services, for purposes of determining eligibility as permitted under Section 1396a(a)(10)(A)(ii)(XXI) of Title 42 of the United States Code. To the extent that federal financial participation is available, the program shall continue to conduct education, outreach, enrollment, service delivery, and evaluation services as specified under the waiver. The services shall be provided under the program only if the waiver and, when applicable, the successor state plan amendment are approved by the federal Centers for Medicare and Medicaid Services and only to the extent that federal financial participation is available for the services. Nothing in this section shall prohibit the department from seeking the Family PACT successor state plan amendment during the operation of the waiver.
(3)Solely for the purposes of the waiver or Family PACT successor state plan amendment and notwithstanding any other law, the collection and use of an individuals social security number shall be necessary only to the extent required by federal law.
(4)Sections 14105.3 to 14105.39, inclusive, 14107.11, 24005, and 24013, and any regulations adopted under these statutes shall apply to the program provided for under this subdivision. No other provision of law under the Medi-Cal program or the State-Only Family Planning Program shall apply to the program provided for under this subdivision.
(5)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement, without taking regulatory action, the provisions of the waiver after its approval by the federal Centers for Medicare and Medicaid Services and the provisions of this section by means of an all-county letter or similar instruction to providers. Thereafter, the department shall adopt regulations to implement this section and the approved waiver in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Beginning six months after the effective date of the act adding this subdivision, the department shall provide a status report to the Legislature on a semiannual basis until regulations have been adopted.
(6)In the event that the Department of Finance determines that the program operated under the authority of the waiver described in paragraph (2) or the Family PACT successor state plan amendment is no longer cost effective, this subdivision shall become inoperative on the first day of the first month following the issuance of a 30-day notification of that determination in writing by the Department of Finance to the chairperson in each house that considers appropriations, the chairpersons of the committees, and the appropriate subcommittees in each house that considers the State Budget, and the Chairperson of the Joint Legislative Budget Committee.
(7)If this subdivision ceases to be operative, all persons who have received or are eligible to receive comprehensive clinical family planning services pursuant to the waiver described in paragraph (2) shall receive family planning services under the Medi-Cal program pursuant to subdivision (n) if they are otherwise eligible for Medi-Cal with no share of cost, or shall receive comprehensive clinical family planning services under the program established in Division 24 (commencing with Section 24000) either if they are eligible for Medi-Cal with a share of cost or if they are otherwise eligible under Section 24003.
(8)For purposes of this subdivision, comprehensive clinical family planning services means the process of establishing objectives for the number and spacing of children, and selecting the means by which those objectives may be achieved. These means include a broad range of acceptable and effective methods and services to limit or enhance fertility, including contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, natural family planning, abstinence methods, and basic, limited fertility management. Comprehensive clinical family planning services include, but are not limited to, preconception counseling, maternal and fetal health counseling, general reproductive health care, including diagnosis and treatment of infections and conditions, including cancer, that threaten reproductive capability, medical family planning treatment and procedures, including supplies and followup, and informational, counseling, and educational services. Comprehensive clinical family planning services shall not include abortion, pregnancy testing solely for the purposes of referral for abortion or services ancillary to abortions, or pregnancy care that is not incident to the diagnosis of pregnancy. Comprehensive clinical family planning services shall be subject to utilization control and include all of the following:
(A)Family planning related services and male and female sterilization. Family planning services for men and women shall include emergency services and services for complications directly related to the contraceptive method, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies, and followup, consultation, and referral services, as indicated, which may require treatment authorization requests.
(B)All United States Department of Agriculture, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies that are in keeping with current standards of practice and from which the individual may choose.
(C)Culturally and linguistically appropriate health education and counseling services, including informed consent, that include all of the following:
(i)Psychosocial and medical aspects of contraception.
(ii)Sexuality.
(iii)Fertility.
(iv)Pregnancy.
(v)Parenthood.
(vi)Infertility.
(vii)Reproductive health care.
(viii)Preconception and nutrition counseling.
(ix)Prevention and treatment of sexually transmitted infection.
(x)Use of contraceptive methods, federal Food and Drug Administration approved contraceptive drugs, devices, and supplies.
(xi)Possible contraceptive consequences and followup.
(xii)Interpersonal communication and negotiation of relationships to assist individuals and couples in effective contraceptive method use and planning families.
(D)A comprehensive health history, updated at the next periodic visit (between 11 and 24 months after initial examination) that includes a complete obstetrical history, gynecological history, contraceptive history, personal medical history, health risk factors, and family health history, including genetic or hereditary conditions.
(E)A complete physical examination on initial and subsequent periodic visits.
(F)Services, drugs, devices, and supplies deemed by the federal Centers for Medicare and Medicaid Services to be appropriate for inclusion in the program.
(9)In order to maximize the availability of federal financial participation under this subdivision, the director shall have the discretion to implement the Family PACT successor state plan amendment retroactively to July 1, 2010.
(ab)(1)Purchase of prescribed enteral nutrition products is covered, subject to the Medi-Cal list of enteral nutrition products and utilization controls.
(2)Purchase of enteral nutrition products is limited to those products to be administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube. Beneficiaries under the Early and Periodic Screening, Diagnosis, and Treatment Program shall be exempt from this paragraph.
(3)Notwithstanding paragraph (2), the department may deem an enteral nutrition product, not administered through a feeding tube, including, but not limited to, a gastric, nasogastric, or jejunostomy tube, a benefit for patients with diagnoses, including, but not limited to, malabsorption and inborn errors of metabolism, if the product has been shown to be neither investigational nor experimental when used as part of a therapeutic regimen to prevent serious disability or death.
(4)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement the amendments to this subdivision made by the act that added this paragraph by means of all-county letters, provider bulletins, or similar instructions, without taking regulatory action.
(5)The amendments made to this subdivision by the act that added this paragraph shall be implemented June 1, 2011, or on the first day of the first calendar month following 60 days after the date the department secures all necessary federal approvals to implement this section, whichever is later.
(ac)Diabetic testing supplies are covered when provided by a pharmacy, subject to utilization controls.
(ad)(1)Nonmedical transportation is covered, subject to utilization controls and permissible time and distance standards, for a beneficiary to obtain covered Medi-Cal services.
(2)(A)(i)Nonmedical transportation includes, at a minimum, round trip transportation for a beneficiary to obtain covered Medi-Cal services by passenger car, taxicab, or any other form of public or private conveyance, and mileage reimbursement when conveyance is in a private vehicle arranged by the beneficiary and not through a transportation broker, bus passes, taxi vouchers, or train tickets.
(ii)Nonmedical transportation does not include the transportation of sick, injured, invalid, convalescent, infirm, or otherwise incapacitated beneficiaries by ambulances, litter vans, or wheelchair vans licensed, operated, and equipped in accordance with state and local statutes, ordinances, or regulations.
(B)Nonmedical transportation shall be provided for a beneficiary who can attest in a manner to be specified by the department that other currently available resources have been reasonably exhausted. For beneficiaries enrolled in a managed care plan, nonmedical transportation shall be provided by the beneficiarys managed care plan. For Medi-Cal fee-for-service beneficiaries, the department shall provide nonmedical transportation when those services are not available to the beneficiary under Sections 14132.44 and 14132.47.
(3)Nonmedical transportation shall be provided in a form and manner that is accessible, in terms of physical and geographic accessibility, for the beneficiary and consistent with applicable state and federal disability rights laws.
(4)It is the intent of the Legislature in enacting this subdivision to affirm the requirement under Section 431.53 of Title 42 of the Code of Federal Regulations, in which the department is required to provide necessary transportation, including nonmedical transportation, for recipients to and from covered services. This subdivision shall not be interpreted to add a new benefit to the Medi-Cal program.
(5)The department shall seek any federal approvals that may be required to implement this subdivision, including, but not limited to, approval of revisions to the existing state plan that the department determines are necessary to implement this subdivision.
(6)This subdivision shall be implemented only to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained.
(7)Prior to the effective date of any necessary federal approvals, nonmedical transportation was not a Medi-Cal managed care benefit with the exception of when provided as an Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) service.
(8)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department, without taking any further regulatory action, shall implement, interpret, or make specific this subdivision by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions until the time regulations are adopted. By July 1, 2018, the department shall adopt regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Commencing January 1, 2018, and notwithstanding Section 10231.5 of the Government Code, the department shall provide a status report to the Legislature on a semiannual basis, in compliance with Section 9795 of the Government Code, until regulations have been adopted.
(9)This subdivision shall not be implemented until July 1, 2017.
(ae)(1)Continuous glucose monitors are covered when medically necessary for the management and treatment of type 1 diabetes, type 2 diabetes, and gestational diabetes.
(2)This subdivision shall be implemented only to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
|
Date
|
Status
|
|---|---|
| Jan 12, 2018 | Stricken from file. |
| Jan 3, 2018 | Consideration of Governor's veto pending. |
| Oct 13, 2017 | Vetoed by Governor. |
| Sep 18, 2017 | Enrolled and presented to the Governor at 4 p.m. |
| Sep 11, 2017 | Senate amendments concurred in. To Engrossing and Enrolling. |
| Sep 6, 2017 | In Assembly. Concurrence in Senate amendments pending. May be considered on or after September 8 pursuant to Assembly Rule 77. |
| Sep 6, 2017 | Read third time. Passed. Ordered to the Assembly. |
| Sep 5, 2017 | Read second time. Ordered to third reading. |
| Sep 1, 2017 | From committee: Do pass. (Ayes 7. Noes 0.) (September 1). |
| Aug 21, 2017 | In committee: Referred to APPR. suspense file. |
| Jul 10, 2017 | Read second time and amended. Re-referred to Com. on APPR. |
| Jul 6, 2017 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 9. Noes 0.) (July 5). |
| Jun 14, 2017 | Referred to Com. on HEALTH. |
| Jun 1, 2017 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 31, 2017 | Read third time. Passed. Ordered to the Senate. (Ayes 77. Noes 0. Page 1927.) |
| May 30, 2017 | Read second time. Ordered to third reading. |
| May 26, 2017 | From committee: Amend, and do pass as amended. (Ayes 16. Noes 0.) (May 26). |
| May 10, 2017 | In committee: Set, first hearing. Referred to APPR. suspense file. |
| May 1, 2017 | Re-referred to Com. on APPR. |
| Apr 27, 2017 | Read second time and amended. |
| Apr 26, 2017 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 15. Noes 0.) (April 25). |
| Feb 27, 2017 | Referred to Com. on HEALTH. |
| Feb 14, 2017 | From printer. May be heard in committee March 16. |
| Feb 13, 2017 | Read first time. To print. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Sep 11, 2017 | AB 447 GRAY Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Sep 6, 2017 | Assembly 3rd Reading AB447 Gray et al. By Pan | Senate Floor |
Passed |
|
| Sep 1, 2017 | Do pass | Senate Standing Committee on Appropriations |
Passed |
|
| Aug 21, 2017 | Placed on suspense file | Senate Standing Committee on Appropriations |
Passed |
|
| Jul 5, 2017 | Do pass as amended, but first amend, and re-refer to the Committee on [Appropriations] | Senate Standing Committee on Health |
Passed |
|
| May 31, 2017 | AB 447 GRAY Assembly Third Reading | Assembly Floor |
Passed |
|
| May 26, 2017 | Do pass as amended. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 25, 2017 | Do pass as amended and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Health |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| American Diabetes Association | ** Support | Sep 4, 2017 |
| California Academy Of Family Physicians | ** Support | Sep 4, 2017 |
| California Academy of PAs | ** Support | Jul 3, 2017 |
| California Academy of Physician Assistants | ** Support | Sep 4, 2017 |
| California Association For Health Services At Home | ** Support | Sep 4, 2017 |
| California Association Of Health Plans | * Support | Apr 25, 2017 |
| California Health+Advocates | ** Support | Sep 4, 2017 |
| California Life Science Association | * Support | Apr 25, 2017 |
| California Medical Association | ** Support | Sep 4, 2017 |
| California Optometric Association | ** Support | Sep 4, 2017 |
| CarbDM | * Support | Apr 25, 2017 |
| Central California Alliance For Health | ** Support | Sep 4, 2017 |
| David Geffen School of Medicine at UCLA | ** Support | Apr 21, 2017 |
| Dexcom | ** Support | Sep 4, 2017 |
| Golden Valley Health Centers | ** Support | Sep 4, 2017 |
| in home supportive services advisory committee san bernardino | ** Support | Sep 4, 2017 |
| Livingston Community Health | ** Support | Sep 4, 2017 |
| Merced County Board of Supervisors | ** Support | Sep 4, 2017 |
| Several individuals | ** Support | Sep 4, 2017 |
| Stanford Health Care | ** Support | Sep 4, 2017 |
| Stanford Hospital & Clinics | * Support | Apr 25, 2017 |
| UCLA Department of Medicine, Santa Monica Diabetes Center | ** Support | Apr 21, 2017 |
| University of Southern California | * Support | Jul 5, 2017 |
| western center on law and poverty | ** Support | Sep 4, 2017 |
GOVERNOR'S VETO
GV Bill Id:AB 447
Author:(Gray)
As Enrolled Ver:September 13, 2017
2/3 vote
ASSEMBLY: | 77-0 | (May 31, 2017) | SENATE: | 38-0 | (September 6, 2017) |
ASSEMBLY: | 78-0 | (September 11, 2017) |
Original Committee Reference: HEALTH
SUMMARY: Provides Medi-Cal coverage for continuous glucose monitors (CGMs) when medically necessary for the management and treatment of diabetes mellitus, subject to utilization controls, and to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
The Senate amendments add a provision that allows the Department of Health Care Services (DHCS) to require the manufacturer of a CGM to enter into a rebate agreement with DHCS.
FISCAL EFFECT: According to the Senate Appropriations Committee,
- Projected annual costs up to $13 million per year, for coverage of continuous glucose monitors in the Medi-Cal program (General Fund (GF) and federal funds).
The California Health Benefits Review Program (CHBRP) projects that the cost to extend coverage for CGMs to those Medi-Cal managed care enrollees whose managed care plan does not currently provide coverage and to enrollees of a county organized health system plan would be about $2.1 million per year and $385,000 per year, respectively.
This analysis assumes that the per-enrollee cost to provide coverage for CGMs in the fee-for-service system is similar to the costs projected for Medi-Cal managed care and that the current utilization rate in fee-for-service Medi-Cal is currently very low and rises roughly to the same level as is projected for Medi-Cal managed care. Under those assumptions, annual fee-for-service costs would be about $10 million per year. These estimates are subject to a good deal of uncertainty, as is discussed below.
- Unknown potential for offsetting cost savings, due to avoided health care costs from the use of continuous glucose monitors (GF and federal funds).
To the extent that the use of a CGMs would result in better control of blood glucose levels, there could be a reduction in the need for additional health care services such as hospitalizations. However, according to CHBRP, "the use of CGMs [continuous glucose monitors] is associated with improved blood sugar control, but there is no or limited evidence that CGM use directly led to improved clinical outcomes, reduced emergency room or inpatient use, or cost savings when compared to the current standard of care…."
Therefore, it is unlikely that providing coverage for CGMs in Medi-Cal will result in overall cost savings that would offset the costs to provide the benefit, at the population level. For some individual Medi-Cal enrollees, it is likely that there would be improved clinical outcomes and reduced costs. The extent to which the provision of continuous glucose monitors in Medi-Cal would be a cost-effective way to provide care would depend on the utilization controls used by DHCS to target their coverage to patients most likely to benefit clinically from their use.
- One-time administrative costs, likely in the low hundreds of thousands, for DHCS to develop policies about coverage of CGMs, apply for federal approval for their coverage, and make billing system changes (GF and federal funds).
COMMENTS: According to the author, Medi-Cal's refusal to cover CGMs discriminates against the poor who are more likely to be diagnosed with diabetes and experience complications from this chronic disease. Medi-Cal now provides health care coverage for one in three Californians and 43% of the state's total diabetic population. Nearly every other health plan has chosen to cover CGMs, including Covered California, Medicare, and the Medicaid programs in 40 other states, but Medi-Cal refuses to provide coverage for a technology that is clinically proven to improve blood sugar management and reduce the odds of catastrophic consequences from poor diabetes management such as hypoglycemia, amputations, and blindness. The result is that California suffers extreme economic and racial disparities in healthcare outcomes among our diabetic population, and this disparity is particularly acute for economically disadvantaged Californians served by Medi-Cal, who currently undergo up to 10 times as many diabetes-related amputations as their non-Medi-Cal counterparts.
In addition to lab tests and self-monitoring blood glucose, patients and providers may also use CGM to help manage diabetes. Three manufacturers produce federal Food and Drug Administration approved CGMs in the U.S. (Abbott, Dexcom, and Medtronic). These waterproof monitors, also called continuous interstitial glucose monitors, use a thin plastic catheter inserted into the subcutaneous skin (fat layer) just under the skin of the arm, back, or trunk to measure the amount of glucose in the fluid around the cells, called interstitial fluid. CGMs have three components: the sensor is a plastic catheter (inserted with a needle) that is attached to the skin with adhesive tape; or integrated with an insulin pump, depending on the model; the transmitter attaches to the sensor and sends data wirelessly to the receiver; and, the receiver/display is optional and that can be worn on a belt or in a pocket (or can be a part of an insulin pump) for patients using a CGM in real time. Sensors are replaced within seven days, and transmitters must be recharged every three to 14 days. Many CGMs have software that enables patient use of smart devices or remote monitoring.
California Health Benefits Review Program (CHBRP) analysis. Approximately 10.8 million Californians will receive full-scope health insurance through Medi-Cal Managed Care plans (MCMC), County Organized Health System Managed Care (COHS) plans, and the fee-for-service (FFS) program in 2018 (28% of all Californians). The 7.8 million beneficiaries enrolled in MCMC plans have health insurance regulated by the Department of Managed Health Care (DMHC), while beneficiaries receiving health insurance through COHS plans and the FFS program have plans overseen by DHCS. If enacted, this bill would affect the health insurance of beneficiaries in MCMC plans, FFS program, and COHS plans. This bill does not impact privately funded DMHC or California Department of Insurance regulated plans or policies. Based on data from 2008 and 2013, the Centers for Disease Control and Prevention (CDC) estimates that diabetes costs Medi-Cal $3 billion annually in medical costs. For all payers across California, including Medi-Cal, the CDC estimates indirect costs for all patients with diabetes (e.g., absenteeism, presenteeism, household productivity loss, inability to work, and premature mortality) are $30 billion annually (2013) and direct medical costs are $20.4 billion (2013).
CHBRP does not estimate that per unit costs in Medi-Cal would change due to this bill. In the absence of Medi-Cal claims data or managed care fee schedule information, and because price information from FFS is not available, CHBRP calculated a likely Medi-Cal cost per unit using MarketScan data. Based upon two separate sources on the ratio of commercial, Medicare, and Medicaid fees, CHBRP determined that the cost per unit for CGM would be approximately 46% of the commercial rates seen in MarketScan data. CHBRP assumes, on average, that rate is already being paid by the managed care plans that cover CGM and the likely cost per unit post mandate would be the same, but more beneficiaries would use CGM and have it covered by their MCMC or COHS plan or the FFS program. CHBRP estimated that CGMs would cost $280 per unit, for a total of $883 annually per user. In addition, $955 is spent on average for other supplies related to diabetes management. The mandate would not change the estimated unit cost or annual cost per user, but it would increase the number of potential users due to the increase in Medi-Cal enrollees with coverage for CGMs (9.3% in MCMC and COHS, and 100% in FFS). This bill would increase total net annual expenditures by $2.1 million (0.0075% of managed care expenditures) for MCMC plans.
Enrollees would not see an increase in out-of-pocket expenditures because of the prohibition on cost sharing for low-income beneficiaries in Medi-Cal. CHBRP anticipates that MCMC and COHS plans and the FFS program would use similar prior authorization, utilization review, treatment authorization requests, and provider guidance to cover CGMs when medically necessary. Although COHS are excluded because they are not DMHC-regulated, CHBRP estimated increases in use and expenditures separately. Using the same 2015 California Health Interview Survey data used for the Medi-Cal managed care population, CHBRP estimated baseline prevalence of potential CGM users and utilization of other diabetes supplies and change post mandate. The state expenditures for Medi-Cal COHS Plans are estimated to increase by $385,000 due to 9.3% of the COHS enrollees who would gain coverage for CGM due to this bill. These impacts assume similarity (in terms of age/sex and disease prevalence, and unit cost) between beneficiaries enrolled in DMHC-plans and beneficiaries enrolled in COHS. As it is not clear how similar the circumstances of the FFS beneficiaries are to the beneficiaries enrolled in DMHC-regulated plans, CHBRP cannot estimate an impact, but presumes there would be an impact for beneficiaries receiving benefits through the FFS program.
CHBRP is unable to estimate a percent change in Medi-Cal spending in the FFS program due to lack of detailed information on the budget and overall spending. In addition, because FFS is often a transitional or temporary state for pending applicants, medically indigent beneficiaries with a share of cost, emergency Medi-Cal beneficiaries, and specific carved-out groups (like California Children's Services beneficiaries), CHBRP cannot accurately predict when beneficiaries would use these services within the year of analysis (2018). It is possible that use would occur after beneficiaries have transitioned into MCMC plans. Not every FFS group is transitioned into a managed care plan, but the complication of modeling transitions for pending applicants, retroactive claiming processes, carve-outs, and medical exceptions make it difficult to estimate the exact source of the future spending due to the mandate.
Additionally, CHBRP estimates that 90.7% of beneficiaries with MCMC coverage currently have coverage for CGMs for the treatment and management of diabetes. Conversely, 0% of beneficiaries in the FFS program have coverage for CGM for the treatment and management of diabetes.
In January 2017, the Centers for Medicare & Medicaid Services ruled therapeutic CGMs would be covered under the Durable Medical Equipment Medicare Part B benefit when "determined to be reasonable and necessary for the treatment of diabetes illness." Replacement of essential accessories for the monitor would also be covered. For Medi-Cal beneficiaries dually enrolled in Medicare (dual-eligible), Medicare is the primary payer. CHBRP assumes that cost sharing for Medicare beneficiaries using therapeutic CGMs would be covered by Medi-Cal and that Medicare beneficiaries do not have coverage for adjunctive CGMs. However, CHBRP also assumes that Medi-Cal reimbursements for CGMs are below Medicare's reimbursement, meaning Medi-Cal would not pay for a dual-eligible's cost sharing portion. Medi-Cal would be the primary payer if a dually eligible Medi-Cal/Medicare beneficiary receives a medically necessary adjunctive CGM.
I am returning Assembly Bills 391 and 447 without my signature.
These bills expand benefits in the Medi-Cal program, one for asthma preventative services and one for continuous glucose monitor medical devices. The Department of Health Care Services, however, has considerable administrative authority to make changes to benefits based upon new medical evidence and clinical guidelines. Therefore, these statutory changes are unnecessary.
Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0002486
CONCURRENCE IN SENATE AMENDMENTS
CSA1 Bill Id:AB 447
Author:(Gray)
As Amended Ver:July 10, 2017
Majority vote
ASSEMBLY: | 77-0 | (May 31, 2017) | SENATE: | 38-0 | (September 6, 2017) |
Original Committee Reference: HEALTH
SUMMARY: Provides Medi-Cal coverage for continuous glucose monitors (CGMs) when medically necessary for the management and treatment of diabetes mellitus, subject to utilization controls, and to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
The Senate amendments add a provision that allows the Department of Health Care Services (DHCS) to require the manufacturer of a CGM to enter into a rebate agreement with DHCS.
FISCAL EFFECT: According to the Senate Appropriations Committee,
- Projected annual costs up to $13 million per year, for coverage of continuous glucose monitors in the Medi-Cal program (General Fund (GF) and federal funds).
The California Health Benefits Review Program (CHBRP) projects that the cost to extend coverage for CGMs to those Medi-Cal managed care enrollees whose managed care plan does not currently provide coverage and to enrollees of a county organized health system plan would be about $2.1 million per year and $385,000 per year, respectively.
This analysis assumes that the per-enrollee cost to provide coverage for CGMs in the fee-for-service system is similar to the costs projected for Medi-Cal managed care and that the current utilization rate in fee-for-service Medi-Cal is currently very low and rises roughly to the same level as is projected for Medi-Cal managed care. Under those assumptions, annual fee-for-service costs would be about $10 million per year. These estimates are subject to a good deal of uncertainty, as is discussed below.
- Unknown potential for offsetting cost savings, due to avoided health care costs from the use of continuous glucose monitors (GF and federal funds).
To the extent that the use of a CGMs would result in better control of blood glucose levels, there could be a reduction in the need for additional health care services such as hospitalizations. However, according to CHBRP, "the use of CGMs [continuous glucose monitors] is associated with improved blood sugar control, but there is no or limited evidence that CGM use directly led to improved clinical outcomes, reduced emergency room or inpatient use, or cost savings when compared to the current standard of care…."
Therefore, it is unlikely that providing coverage for CGMs in Medi-Cal will result in overall cost savings that would offset the costs to provide the benefit, at the population level. For some individual Medi-Cal enrollees, it is likely that there would be improved clinical outcomes and reduced costs. The extent to which the provision of continuous glucose monitors in Medi-Cal would be a cost-effective way to provide care would depend on the utilization controls used by DHCS to target their coverage to patients most likely to benefit clinically from their use.
- One-time administrative costs, likely in the low hundreds of thousands, for DHCS to develop policies about coverage of CGMs, apply for federal approval for their coverage, and make billing system changes (GF and federal funds).
COMMENTS: According to the author, Medi-Cal's refusal to cover CGMs discriminates against the poor who are more likely to be diagnosed with diabetes and experience complications from this chronic disease. Medi-Cal now provides health care coverage for one in three Californians and 43% of the state's total diabetic population. Nearly every other health plan has chosen to cover CGMs, including Covered California, Medicare, and the Medicaid programs in 40 other states, but Medi-Cal refuses to provide coverage for a technology that is clinically proven to improve blood sugar management and reduce the odds of catastrophic consequences from poor diabetes management such as hypoglycemia, amputations, and blindness. The result is that California suffers extreme economic and racial disparities in healthcare outcomes among our diabetic population, and this disparity is particularly acute for economically disadvantaged Californians served by Medi-Cal, who currently undergo up to 10 times as many diabetes-related amputations as their non-Medi-Cal counterparts.
In addition to lab tests and self-monitoring blood glucose, patients and providers may also use CGM to help manage diabetes. Three manufacturers produce federal Food and Drug Administration approved CGMs in the U.S. (Abbott, Dexcom, and Medtronic). These waterproof monitors, also called continuous interstitial glucose monitors, use a thin plastic catheter inserted into the subcutaneous skin (fat layer) just under the skin of the arm, back, or trunk to measure the amount of glucose in the fluid around the cells, called interstitial fluid. CGMs have three components: the sensor is a plastic catheter (inserted with a needle) that is attached to the skin with adhesive tape; or integrated with an insulin pump, depending on the model; the transmitter attaches to the sensor and sends data wirelessly to the receiver; and, the receiver/display is optional and that can be worn on a belt or in a pocket (or can be a part of an insulin pump) for patients using a CGM in real time. Sensors are replaced within seven days, and transmitters must be recharged every three to 14 days. Many CGMs have software that enables patient use of smart devices or remote monitoring.
California Health Benefits Review Program (CHBRP) analysis. Approximately 10.8 million Californians will receive full-scope health insurance through Medi-Cal Managed Care plans (MCMC), County Organized Health System Managed Care (COHS) plans, and the fee-for-service (FFS) program in 2018 (28% of all Californians). The 7.8 million beneficiaries enrolled in MCMC plans have health insurance regulated by the Department of Managed Health Care (DMHC), while beneficiaries receiving health insurance through COHS plans and the FFS program have plans overseen by DHCS. If enacted, this bill would affect the health insurance of beneficiaries in MCMC plans, FFS program, and COHS plans. This bill does not impact privately funded DMHC or California Department of Insurance regulated plans or policies. Based on data from 2008 and 2013, the Centers for Disease Control and Prevention (CDC) estimates that diabetes costs Medi-Cal $3 billion annually in medical costs. For all payers across California, including Medi-Cal, the CDC estimates indirect costs for all patients with diabetes (e.g., absenteeism, presenteeism, household productivity loss, inability to work, and premature mortality) are $30 billion annually (2013) and direct medical costs are $20.4 billion (2013).
CHBRP does not estimate that per unit costs in Medi-Cal would change due to this bill. In the absence of Medi-Cal claims data or managed care fee schedule information, and because price information from FFS is not available, CHBRP calculated a likely Medi-Cal cost per unit using MarketScan data. Based upon two separate sources on the ratio of commercial, Medicare, and Medicaid fees, CHBRP determined that the cost per unit for CGM would be approximately 46% of the commercial rates seen in MarketScan data. CHBRP assumes, on average, that rate is already being paid by the managed care plans that cover CGM and the likely cost per unit post mandate would be the same, but more beneficiaries would use CGM and have it covered by their MCMC or COHS plan or the FFS program. CHBRP estimated that CGMs would cost $280 per unit, for a total of $883 annually per user. In addition, $955 is spent on average for other supplies related to diabetes management. The mandate would not change the estimated unit cost or annual cost per user, but it would increase the number of potential users due to the increase in Medi-Cal enrollees with coverage for CGMs (9.3% in MCMC and COHS, and 100% in FFS). This bill would increase total net annual expenditures by $2.1 million (0.0075% of managed care expenditures) for MCMC plans.
Enrollees would not see an increase in out-of-pocket expenditures because of the prohibition on cost sharing for low-income beneficiaries in Medi-Cal. CHBRP anticipates that MCMC and COHS plans and the FFS program would use similar prior authorization, utilization review, treatment authorization requests, and provider guidance to cover CGMs when medically necessary. Although COHS are excluded because they are not DMHC-regulated, CHBRP estimated increases in use and expenditures separately. Using the same 2015 California Health Interview Survey data used for the Medi-Cal managed care population, CHBRP estimated baseline prevalence of potential CGM users and utilization of other diabetes supplies and change post mandate. The state expenditures for Medi-Cal COHS Plans are estimated to increase by $385,000 due to 9.3% of the COHS enrollees who would gain coverage for CGM due to this bill. These impacts assume similarity (in terms of age/sex and disease prevalence, and unit cost) between beneficiaries enrolled in DMHC-plans and beneficiaries enrolled in COHS. As it is not clear how similar the circumstances of the FFS beneficiaries are to the beneficiaries enrolled in DMHC-regulated plans, CHBRP cannot estimate an impact, but presumes there would be an impact for beneficiaries receiving benefits through the FFS program.
CHBRP is unable to estimate a percent change in Medi-Cal spending in the FFS program due to lack of detailed information on the budget and overall spending. In addition, because FFS is often a transitional or temporary state for pending applicants, medically indigent beneficiaries with a share of cost, emergency Medi-Cal beneficiaries, and specific carved-out groups (like California Children's Services beneficiaries), CHBRP cannot accurately predict when beneficiaries would use these services within the year of analysis (2018). It is possible that use would occur after beneficiaries have transitioned into MCMC plans. Not every FFS group is transitioned into a managed care plan, but the complication of modeling transitions for pending applicants, retroactive claiming processes, carve-outs, and medical exceptions make it difficult to estimate the exact source of the future spending due to the mandate.
Additionally, CHBRP estimates that 90.7% of beneficiaries with MCMC coverage currently have coverage for CGMs for the treatment and management of diabetes. Conversely, 0% of beneficiaries in the FFS program have coverage for CGM for the treatment and management of diabetes.
In January 2017, the Centers for Medicare & Medicaid Services ruled therapeutic CGMs would be covered under the Durable Medical Equipment Medicare Part B benefit when "determined to be reasonable and necessary for the treatment of diabetes illness." Replacement of essential accessories for the monitor would also be covered. For Medi-Cal beneficiaries dually enrolled in Medicare (dual-eligible), Medicare is the primary payer. CHBRP assumes that cost sharing for Medicare beneficiaries using therapeutic CGMs would be covered by Medi-Cal and that Medicare beneficiaries do not have coverage for adjunctive CGMs. However, CHBRP also assumes that Medi-Cal reimbursements for CGMs are below Medicare's reimbursement, meaning Medi-Cal would not pay for a dual-eligible's cost sharing portion. Medi-Cal would be the primary payer if a dually eligible Medi-Cal/Medicare beneficiary receives a medically necessary adjunctive CGM.
Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0001748
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 447
:
SENATE HEALTH COMMITTEE: 9-0, 7/5/17
AYES: Hernandez, Nguyen, Atkins, Leyva, Mitchell, Monning, Newman, Nielsen, Roth
SENATE APPROPRIATIONS COMMITTEE: 7-0, 9/1/17
AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener
ASSEMBLY FLOOR: 77-0, 5/31/17 - See last page for vote
DIGEST:
This bill requires Medi-Cal to provide coverage for continuous glucose monitors and related supplies required for use with those monitors that are covered for the treatment of diabetes mellitus when medically necessary, subject to utilization controls.
Existing law:
- Establishes the Medi-Cal program, administered by Department of Health Care Services (DHCS), under which health care services are provided to qualified low-income persons.
- Establishes a schedule of benefits in Medi-Cal, which includes the following:
- Durable medical equipment and medical supplies, subject to utilization controls;
- Therapeutic shoes and inserts are covered when provided to beneficiaries with a diagnosis of diabetes, subject to utilization controls, to the extent that federal financial participation is available; and,
- Diabetic testing supplies are covered when provided by a pharmacy, subject to utilization controls.
- Prohibits Medi-Cal payment for diabetic testing supplies from exceeding the estimated acquisition cost of the item dispensed, as defined by DHCS, plus a fee equal to the maximum professional fee component used in the payment for legend generic drug types.
This bill:
- Requires Medi-Cal to provide coverage for continuous glucose monitors (CGM) and related supplies required for use with those monitors that are covered for the treatment of diabetes mellitus when medically necessary, subject to utilization controls.
- Authorizes DHCS to require the manufacturer of a CGM to enter into a rebate agreement with DHCS.
- Implements this bill only to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
Comments
- Author’s statement. According to the author, Medi-Cal’s refusal to cover CGMs discriminates against people of color and the poor who are more likely to be diagnosed with diabetes and experience complications from this chronic disease. Medi-Cal now provides health care coverage for one in three Californians and 43% of the state’s total diabetic population. Nearly every other health plan has chosen to cover continuous glucose monitors, including plans in Covered California, Medicare, and the Medicaid programs in 30 other states, but Medi-Cal refuses to provide coverage for a technology that is clinically proven to improve blood sugar management and reduce the odds of catastrophic consequences from poor diabetes management such as hypoglycemia, amputations, and blindness. The result is that Californians suffer extreme economic and racial disparities in health care outcomes among our diabetic population, and this disparity is particularly acute for economically disadvantaged Californians served by Medi-Cal, who currently undergo up to 10 times as many diabetes-related amputations as their non-Medi-Cal counterparts.
- Diabetes mellitus( DM). DM is a chronic disease with short-and long-term health effects that prevent the proper production of and/or response to insulin, a hormone that facilitates the transfer of glucose into cells to provide energy. The two primary types of diabetes affected by this bill are as follows:
- Type 1 diabetes mellitus (T1DM) is an autoimmune disease, most commonly diagnosed during childhood/adolescence that attacks and destroys the insulin-producing cells in the pancreas. In addition to dietary modifications, treatment requires lifetime use of daily insulin injections and/or an insulin pump used to replace the patient’s impaired ability to produce insulin, and attention to diet.
- Type 2 diabetes mellitus (T2DM) is most commonly diagnosed in middle-aged or older adults, although it has been increasingly diagnosed in children and adolescents. Type 2 diabetes prevents the body from properly responding to insulin (known as insulin resistance). In some cases, people with T2D M also do not make enough insulin. It is associated with obesity, genetics, and lifestyle patterns. Treatments for T2DM include diet modifications, exercise, weight loss, oral medications, non-insulin injected medications, and/or insulin depending on the severity of the disease, which progresses over time especially with inadequate treatment.
Achieving stable, healthy blood glucose levels is challenging for individuals with diabetes and has adverse health consequence in the short and long-term. On a daily basis, people with diabetes can experience swings between very high blood glucose levels (hyperglycemia) and extremely low blood glucose levels (hypoglycemia). Changes in stress, sleep, physical activity, diet, and acute illnesses contribute to hyper-and hypoglycemic events. Hyperglycemia is exhibited through increased thirst or hunger, frequent urination, headache, and fatigue. Left untreated, particularly in T1DM, it may develop into ketoacidosis where the body develops a toxic amount of ketones (toxic acids) for energy, which can lead to coma or death. Symptoms of hypoglycemia can begin as mild (e.g., anxiety, sleepiness, and tremors) and, if left untreated, escalate to serious health events such as cognitive dysfunction, seizures, coma, and death.
- Monitoring of blood glucose. Managing diabetes requires checking blood glucose levels through lab tests (HbA1c periodically ordered by health care providers) and daily patient self-monitoring blood glucose (SMBG), also known as a finger stick. HbA1c indicates a patient’s average glucose level over the last three months. The lab results are used by health care providers to inform the patient’s diabetes management plan. Patients perform SMBG tests 1 to 10 times/day to obtain “snapshot” glucose readings to help them adjust their insulin, diet, physical activity, or oral medication throughout the day and night. More frequent testing is required for insulin-dependent patients and those who have uncontrolled blood sugars, including hypoglycemia and hyperglycemia. SMBG requires the patient to prick the skin (commonly the finger for the most accurate reading) for a drop of blood, which is applied to a test strip. The strip is inserted into a handheld blood glucose monitor (glucometer) which displays a reading for the current glucose level. Optimal HbA1c is at 7% which corresponds to an average SMBG number of 154mg/dL. Blood sugars are best kept between 80 and 160 mg/dL throughout the day.
In addition to HbA1c lab tests and SMBG, patients and providers may also use continuous glucose monitors (CGM) to help manage diabetes. Three manufacturers produce FDA-approved CGMs in the U.S. (i.e., Abbott, Dexcom, and Medtronic). These waterproof monitors, also called continuous interstitial glucose monitors, use a thin plastic catheter inserted into the subcutaneous skin (fat layer) just under the skin of the arm, back, or trunk to measure the amount of glucose in the fluid around the cells, called interstitial fluid.
CGMs may be categorized as retrospective or in real time based on how often and by whom the glucose level readings are reviewed. Under the retrospective (professional) scenario, a health care provider asks the patient to wear the CGM for 72 hours (to one week) to record glucose measurements every five to 15 minutes for the duration. The patient does not see the CGM glucose levels while wearing the device. The patient returns to the provider who downloads and analyzes the retrospective data for patterns in glucose control. The provider can use this retrospective data to see when hyper-and hypoglycemia events undetected by SMBG are occurring, and to understand why a patient’s HbA1c remains uncontrolled even if SMGB results appear controlled.
Under the real-time use scenario, CGMs are worn by the patient to actively and consistently monitor glucose throughout the day and night. The patients are able to see the CGM glucose levels on their receivers (or smart phones) as the measurements are taken throughout the day and night. They also have the option to set an alarm to alert them when glucose levels go too high or too low. For real-time use, patients must move the sensor to a different place on the body at least once per week. As with data collected from a retrospective CGM, the patient and the provider can also review the detailed data to better understand the user’s glucose level patterns over time and adjust the treatment regimen accordingly.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Senate Appropriations Committee:
- Projected annual costs up to $13 million per year, for coverage of CGMs in the Medi-Cal program (General Fund and federal funds).
The California Health Benefits Review Program (CHBRP) projects that the cost to extend coverage for CGMs to those Medi-Cal managed care enrollees whose managed care plan does not currently provide coverage and to enrollees of a county organized health system plan would be about $2.1 million per year and $385,000 per year, respectively.
This analysis assumes that the per-enrollee cost to provide coverage for CGMs in the fee-for-service system is similar to the costs projected for Medi-Cal managed care and that the current utilization rate in fee-for-service Medi-Cal is currently very low and rises roughly to the same level as is projected for Medi-Cal managed care. Under those assumptions, annual fee-for-service costs would be about $10 million per year. These estimates are subject to a good deal of uncertainty, as is discussed below.
- Unknown potential for offsetting cost savings, due to avoided health care costs from the use of CGMs (General Fund and federal funds).
To the extent that the use of a CGM would result in better control of blood glucose levels, there could be a reduction in the need for additional health care services such as hospitalizations. However, according to the CHBRP, “the use of CGMs [continuous glucose monitors] is associated with improved blood sugar control, but there is no or limited evidence that CGM use directly led to improved clinical outcomes, reduced emergency room or inpatient use, or cost savings when compared to the current standard of care…”.
Therefore, it is unlikely that providing coverage for CGMs in Medi-Cal will result in overall cost savings that would offset the costs to provide the benefit, at the population level. For some individual Medi-Cal enrollees, it is likely that there would be improved clinical outcomes and reduced costs. The extent to which the provision of CGMs in Medi-Cal would be a cost-effective way to provide care would depend on the utilization controls used by DHCS to target their coverage to patients most likely to benefit clinically from their use.
- One-time administrative costs, likely in the low hundreds of thousands, for the DHCS to develop policies about coverage of continuous glucose monitors, apply for federal approval for their coverage, and make billing system changes (General Fund and federal funds).
American Diabetes Association
California Academy of Family Physicians
California Academy of Physician Assistants
California Association for Health Services at Home
California Medical Association
California Optometric Association
California Health+Advocates
Central California Alliance for Health
Dexcom
Golden Valley Health Centers
In Home Supportive Services Advisory Committee San Bernardino
Livingston Community Health
Merced County Board of Supervisors
Stanford Health Care
Western Center on Law and Poverty
Several individuals
OPPOSITION: (Verified 8/30/17)
None received
ARGUMENTS IN SUPPORT: The American Diabetes Association writes in support that most states’ Medicaid programs coverage CGM because it improves diabetes control and prevents greater costs from hospitalizations and treatment of complications. Dexcom, a manufacturer of CGM, writes in support that this bill will improve the lives of Medi-Cal enrollees living with diabetes while simultaneously assist in lowering Medi-Cal costs associated with care and treatment of diabetes. Dexcom writes that CGMs continuously monitor interstitial glucose levels and uses alarms and alerts to inform patients when blood glucose level is exceeding or falling below specified thresholds. The device helps guide disease management decisions, such as insulin dosage adjustments or dietary changes. For patients with hypoglycemia unawareness, the alarm function may be their only warning of emerging hypoglycemia. CGM systems have the ability to save the Medi-Cal program millions of dollars in hospitalizations. Each hospitalization due to hypoglycemia has an average cost of $17,652, while the average cost for a CGM device is mere fraction of that number, around $4,700. Dexcom states every major commercial plan in California currently covers CGM technologies because they recognize the value of CGMs in improving outcomes and lowering the total cost of treating diabetes. By adding CGM systems that are medically necessary for the management and treatment of diabetes to the schedule of benefits under the Medi-Cal program, Dexcom argues this bill will help to improve the lives of Medi-Cal enrollees with diabetes.
ASSEMBLY FLOOR: 77-0, 5/31/17
AYES: Acosta, Aguiar-Curry, Travis Allen, Arambula, Baker, Berman, Bigelow, Bloom, Bocanegra, Bonta, Brough, Burke, Caballero, Calderon, Cervantes, Chau, Chávez, Chen, Chiu, Chu, Cooley, Cooper, Cunningham, Dababneh, Dahle, Daly, Flora, Fong, Frazier, Friedman, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gomez, Gonzalez Fletcher, Gray, Grayson, Harper, Holden, Irwin, Jones-Sawyer, Kalra, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Quirk, Quirk-Silva, Reyes, Ridley-Thomas, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Voepel, Waldron, Weber, Wood, Rendon
NO VOTE RECORDED: Choi, Eggman, Melendez
9/4/17 12:19:14
**** END ****
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2017 - 2018 Regular Session
AB 447 (Gray) - Medi-Cal: covered benefits: continuous glucose monitors
Version: July 10, 2017 | Policy Vote: HEALTH 9 - 0 |
Urgency: No | Mandate: No |
Hearing Date: August 21, 2017 | Consultant: Brendan McCarthy |
This bill meets the criteria for referral to the Suspense File.
Bill Summary:
AB 447 would require Medi-Cal to provide coverage for continuous glucose monitors and related supplies for the treatment of diabetes mellitus.
Fiscal Impact:
- Projected annual costs up to $13 million per year, for coverage of continuous glucose monitors in the Medi-Cal program (General Fund and federal funds).
The California Health Benefits Review Program projects that the cost to extend coverage for continuous glucose monitors to those Medi-Cal managed care enrollees whose managed care plan does not currently provide coverage and to enrollees of a county organized health system plan would be about $2.1 million per year and $385,000 per year, respectively.
This analysis assumes that the per-enrollee cost to provide coverage for continuous glucose monitors in the fee-for-service system is similar to the costs projected for Medi-Cal managed care and that the current utilization rate in fee-for-service Medi-Cal is currently very low and rises roughly to the same level as is projected for Medi-Cal managed care. Under those assumptions, annual fee-for-service costs would be about $10 million per year. These estimates are subject to a good deal of uncertainty, as is discussed below.
- Unknown potential for offsetting cost savings, due to avoided health care costs from the use of continuous glucose monitors (General Fund and federal funds).
To the extent that the use of a continuous glucose monitor would result in better control of blood glucose levels, there could be a reduction in the need for additional health care services such as hospitalizations. However, according to the California Health Benefits Review Program, “the use of CGMs [continuous glucose monitors] is associated with improved blood sugar control, but there is no or limited evidence that CGM use directly led to improved clinical outcomes, reduced emergency room or inpatient use, or cost savings when compared to the current standard of care…”.
Therefore, it is unlikely that providing coverage for continuous glucose monitors in Medi-Cal will result in overall cost savings that would offset the costs to provide the benefit, at the population level. For some individual Medi-Cal enrollees, it is likely that there would be improved clinical outcomes and reduced costs. The extent to which the provision of continuous glucose monitors in Medi-Cal would be a cost-effective way to provide care would depend on the utilization controls used by the Department of Health Care Services to target their coverage to patients most likely to benefit clinically from their use.
- One-time administrative costs, likely in the low hundreds of thousands, for the Department of Health Care Services to develop policies about coverage of continuous glucose monitors, apply for federal approval for their coverage, and make billing system changes (General Fund and federal funds).
Background:
Under state and federal law, the Department of Health Care Services operates the Medi-Cal program, which provides health care coverage to low income individuals, families, and children. Medi-Cal provides coverage to childless adults and parents with household incomes up to 138% of the federal poverty level and to children with household incomes up to 266% of the federal poverty level. The federal government provides matching funds that vary from 50% to 90% of expenditures depending on the category of beneficiary.
Continuous glucose monitors allow patients with diabetes to better track their blood glucose levels. For some patients, when blood glucose levels are poorly controlled, there can be adverse health events leading to hospitalization. Short-term instances of either very high blood glucose levels (hyperglycemia) or very low blood glucose levels (hypoglycemia) can result in a variety of short-term impacts that may necessitate hospitalization. In addition, there are a number of serious health impacts associated with long-term poorly controlled blood glucose levels.
Under current law, continuous glucose monitors are not explicitly covered by Medi-Cal, although they could be covered as durable medical equipment. In practice, it seems that they have not been covered in the Medi-Cal fee-for-service system or by county organized health systems that contract to provide coverage for Medi-Cal beneficiaries. Most Medi-Cal managed care plans indicate that they do provide coverage for continuous glucose monitors. However, there are also indications that some Medi-Cal managed care plans have denied coverage on the grounds that continuous glucose monitors are not a covered benefit. Overall, there seems to be a good deal of uncertainty about whether these devices are covered by Medi-Cal, even when prescribed by a physician who has indicated that they are medically necessary.
Proposed Law:
AB 447 would require continuous glucose monitors to be a covered benefit in the Medi-Cal program, for the treatment of diabetes mellitus, when medically necessary. Coverage would be subject to utilization controls. The bill would authorize the Department to require manufacturers to provide negotiated rebates to the Department of Health Care Services. The provisions of the bill would only be implemented to the extent that federal approval has been obtained and federal financial participation is available.
Staff Comments:
As noted above, there is a good deal of uncertainty about whether continuous glucose monitors are actually covered in the Medi-Cal program. According to the Department of Health Care Services, continuous glucose monitors are a “non-covered benefit”. This means that they are not explicitly required to be covered, but that the a Medi-Cal beneficiary can receive coverage for the device, subject to Department utilization controls, if a health care provider shows that the device is medically necessary for the patient.
However, the Department has also denied coverage for the devices on the grounds that a “continuous glucose monitor is not a Medi-Cal benefit, however, even with a prior authorization request”. The ambiguity in the state’s policy towards continuous glucose monitors indicates that some enrollees are able to access the devices and other enrollees are not.
The California Health Benefits Review Program was not able to project the costs to provide coverage to the Medi-Cal fee-for-service population. The cost estimates above made by staff assume that the utilization rate for the fee-for-service population is currently close to zero and would increase to a level similar to the projected utilization rate in Medi-Cal managed care and that annual per user costs would be similar. It is important to note that there may be variations in the incidence of diabetes and other conditions that skew the overall population health of the Medi-Cal fee-for-service population relative to the managed care population. To the extent that that health status amongst the fee-for-service population is not comparable to the managed care population, fee-for-service costs (and any offsetting savings) could be higher or lower.
To the extent that Medi-Cal does provide coverage for continuous glucose monitors, the rates paid by the state directly or through Medi-Cal managed care plans are typically based on rates paid by Medicare. Generally, the state pays for durable medical equipment at not more than 80% of the Medicare rate. The federal government has indicated that it is considering substantially raising the reimbursement rate it pays for continuous glucose monitors. To the extent that it does, future state costs could be higher than is projected above.
-- END --
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 447
AUTHOR: | Gray | ||
VERSION: | May 26, 2017 | ||
HEARING DATE: | July 5, 2017 | ||
CONSULTANT: | Scott Bain | ||
SUBJECT: Medi-Cal: covered benefits: continuous glucose monitors
SUMMARY:
Requires Medi-Cal to provide coverage for continuous glucose monitors and related supplies required for use with those monitors are covered for the treatment of diabetes mellitus when medically necessary, subject to utilization controls.
Existing law:
- Establishes the Medi-Cal program, administered by Department of Health Care Services (DHCS), under which health care services are provided to qualified low-income persons.
- Establishes a schedule of benefits in Medi-Cal, which includes the following:
- Durable medical equipment and medical supplies, subject to utilization controls;
- Therapeutic shoes and inserts are covered when provided to beneficiaries with a diagnosis of diabetes, subject to utilization controls, to the extent that federal financial participation is available; and,
- Diabetic testing supplies are covered when provided by a pharmacy, subject to utilization controls.
- Prohibits Medi-Cal payment for diabetic testing supplies from exceeding exceed the estimated acquisition cost of the item dispensed, as defined by DHCS, plus a fee equal to the maximum professional fee component used in the payment for legend generic drug types.
This bill:
- Requires Medi-Cal to provide coverage for continuous glucose monitors (CGM) and related supplies required for use with those monitors are covered for the treatment of diabetes mellitus when medically necessary, subject to utilization controls.
- Implements this bill only to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
FISCAL EFFECT:
According to the Assembly Appropriations Committee:
- According to the California Health Benefits Review Program (CHBRP), Medi-Cal managed care cost pressure of $2.1 million (General Fund (GF)/federal). Although CHBRP did not estimate utilization and cost in fee-for-service (FFS) Medi-Cal, which currently doesn't cover CGMs, staff estimates FFS expenditures in a roughly similar range based on the number of individuals enrolled in FFS Medi-Cal who would receive coverage for CGMs.
- Minor and absorbable administrative costs to DHCS to update relevant provider manuals, codes, and contacts to add CMGs as a covered benefit (GF/federal).
PRIOR VOTES:
Assembly Floor: | 77 - 0 |
Assembly Appropriations Committee: | 16 - 0 |
Assembly Health Committee: | 15 - 0 |
COMMENTS:
- Author’s statement. According to the author, Medi-Cal’s refusal to cover CGMs discriminates against people of color and the poor who are more likely to be diagnosed with diabetes and experience complications from this chronic disease. Medi-Cal now provides health care coverage for one in three Californians and 43% of the state’s total diabetic population. Nearly every other health plan has chosen to cover continuous glucose monitors, including plans in Covered California, Medicare, and the Medicaid programs in 30 other states, but Medi-Cal refuses to provide coverage for a technology that is clinically proven to improve blood sugar management and reduce the odds of catastrophic consequences from poor diabetes management such as hypoglycemia, amputations, and blindness. The result is that Californians suffers extreme economic and racial disparities in health care outcomes among our diabetic population, and this disparity is particularly acute for economically disadvantaged Californians served by Medi-Cal, who currently undergo up to ten times as many diabetes-related amputations as their non-Medi-Cal counterparts.
- Diabetes mellitus. Diabetes mellitus (DM) is a chronic disease with short-and long-term health effects that prevent the proper production of and/or response to insulin, a hormone that facilitates the transfer of glucose into cells to provide energy. The two primary types of diabetes affected by this bill are as follows:
- Type 1 diabetes mellitus (T1DM) is an autoimmune disease, most commonly diagnosed during childhood/adolescence that attacks and destroys the insulin-producing cells in the pancreas. In addition to dietary modifications, treatment requires lifetime use of daily insulin injections and/or an insulin pump used to replace the patient’s impaired ability to produce insulin, and attention to diet.
- Type 2 diabetes mellitus (T2DM) is most commonly diagnosed in middle-aged or older adults, although it has been increasingly diagnosed in children and adolescents. Type 2 diabetes prevents the body from properly responding to insulin (known as insulin resistance). In some cases, people with T2D M also do not make enough insulin. It is associated with obesity, genetics, and lifestyle patterns. Treatments for T2DM include diet modifications, exercise, weight loss, oral medications, non-insulin injected medications, and/or insulin depending on the severity of the disease, which progresses over time especially with inadequate treatment.
Achieving stable, healthy blood glucose levels is challenging for individuals with diabetes and has adverse health consequence in the short and long-term. On a daily basis, people with diabetes can experience swings between very high blood glucose levels (hyperglycemia) and extremely low blood glucose levels (hypoglycemia). Changes in stress, sleep, physical activity, diet, and acute illnesses contribute to hyper-and hypoglycemic events. Hyperglycemia is exhibited through increased thirst or hunger, frequent urination, headache, and fatigue. Left untreated, particularly in T1DM, it may develop into ketoacidosis where the body develops a toxic amount of ketones (toxic acids) for energy, which can lead to coma or death. Symptoms of hypoglycemia can begin as mild (e.g., anxiety, sleepiness, and tremors) and, if left untreated, escalate to serious health events such as cognitive dysfunction, seizures, coma, and death.
Some patients (between 20% and 40% of T1DM patients and 10% of T2DM patients) are diagnosed with hypoglycemia unawareness a condition in which individuals are unable to sense dangerously low blood sugar early enough to reverse it, which puts them at high risk for severe hypoglycemic events requiring hospitalization. People with this condition are required to perform more frequent blood glucose testing than those who can feel their blood glucose levels dropping. A 2015 study estimated that among people with hypoglycemic unawareness, 2.4 to 8.1 hospitalizations occur annually among T1DM patients, and 2.1 to 5.9 hospitalizations per year among T2DM patients. Hypoglycemia unawareness occurs more frequently among those with a longer duration of diabetes, who are insulin dependent, and/or have a history of hypoglycemic events.
Long-term, time spent in hyperglycemia and frequency and severity of hyper- and hypoglycemia over a lifetime are associated with serious morbidity and mortality outcomes. In the United States, DM is the leading cause of blindness, amputations, and kidney failure, and a key contributor to stroke, heart disease, dental disease, nerve damage, and premature death due to suboptimal blood sugar control. In the long term, uncontrolled gestational DM puts pregnant women and their infants at higher risk of developing T2DM later in life. Although people with diabetes may not avoid all associated comorbidities, tightly controlled blood glucose over time may prevent, delay, or ameliorate some comorbidities.
- Monitoring of blood glucose. Managing diabetes requires checking blood glucose levels through lab tests (HbA1c periodically ordered by health care providers) and daily patient self-monitoring blood glucose (SMBG), also known as a finger stick. HbA1c indicates a patient’s average glucose level over the last three months. The lab results are used by health care providers to inform the patient’s diabetes management plan. Patients perform SMBG tests 1 to 10 times/day to obtain “snapshot” glucose readings to help them adjust their insulin, diet, physical activity, or oral medication throughout the day and night. More frequent testing is required for insulin-dependent patients and those who have uncontrolled blood sugars, including hypoglycemia and hyperglycemia. SMBG requires the patient to prick the skin (commonly the finger for the most accurate reading) for a drop of blood, which is applied to a test strip. The strip is inserted into a handheld blood glucose monitor (glucometer) which displays a reading for the current glucose level. Optimal HbA1c is at 7% which corresponds to an average SMBG number of 154mg/dL. Blood sugars are best kept between 80 and 160 mg/dL throughout the day.
In addition to HbA1c lab tests and SMBG, patients and providers may also use continuous glucose monitors (CGM) to help manage diabetes. Three manufacturers produce FDA-approved CGMs in the U.S. (i.e., Abbott, Dexcom, and Medtronic). These waterproof monitors, also called continuous interstitial glucose monitors, use a thin plastic catheter inserted into the subcutaneous skin (fat layer) just under the skin of the arm, back, or trunk to measure the amount of glucose in the fluid around the cells, called interstitial fluid.
CGMs may be categorized as retrospective or in real time based on how often and by whom the glucose level readings are reviewed. Under the retrospective (professional) scenario, a health care provider asks the patient to wear the CGM for 72 hours (to one week) to record glucose measurements every five to 15 minutes for the duration. The patient does not see the CGM glucose levels while wearing the device. The patient returns to the provider who downloads and analyzes the retrospective data for patterns in glucose control. The provider can use this retrospective data to see when hyper-and hypoglycemia events undetected by SMBG are occurring, and to understand why a patient’s HbA1c remains uncontrolled even if SMGB results appear controlled.
Under the real-time use scenario, CGMs are worn by the patient to actively and consistently monitor glucose throughout the day and night. The patients are able to see the CGM glucose levels on their receivers (or smart phones) as the measurements are taken throughout the day and night. They also have the option to set an alarm to alert them when glucose levels go too high or too low. For real-time use, patients must move the sensor to a different place on the body at least once per week. As with data collected from a retrospective CGM, the patient and the provider can also review the detailed data to better understand the user’s glucose level patterns over time and adjust the treatment regimen accordingly.
- CHBRP review. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP’s analysis of the introduced version of this measure found the following;
- Approximately 91% of beneficiaries enrolled in Medi-Cal Managed Care and COHS and 0% of those receiving benefits through the FFS program have coverage for CGMs. The California Children’s Services Program provides coverage for CGMsl;
- Utilization. Utilization of CGMs is expected to increase from 3.979 per 1,000 Medi-Cal; beneficiaries to 4.386 per 1,000 Med-Cal beneficiaries;
- Expenditures. Expenditures will increase by $2,105,000 for Medi-Cal Managed Care Plans, $385,000 for COHS, and unknown amount for the FFS program should AB 447 be enacted; and,
- Medical effectiveness. There is limited evidence that use of real-time CGMs for patients with T1DM are effective. There is a preponderance of evidence that the use of retrospective CGMs for patients with T1DM are not effective. T2DM. There is limited evidence that use of retrospective and real-time CGMs are not effective for patients with T2DM.
- Support. The American Diabetes Association writes in support that most states’ Medicaid programs coverage CGM because it improves diabetes control and prevents greater costs from hospitalizations and treatment of complications. Dexcom, a manufacturer of CGM, writes in support that this bill will improve the lives of Medi-Cal enrollees living with diabetes while simultaneously assist in lowering Medi-Cal costs associated with care and treatment of diabetes. Dexcom writes that CGMs continuously monitor interstitial glucose levels and uses alarms and alerts to inform patients when blood glucose level is exceeding or falling below specified thresholds. The device helps guide disease management decisions, such as insulin dosage adjustments or dietary changes. For patients with hypoglycemia unawareness, the alarm function may be their only warning of emerging hypoglycemia. CGM systems have the ability to save the Medi-Cal program millions of dollars in hospitalizations. Each hospitalization due to hypoglycemia has an average cost of $17,652, while the average cost for a CGM device is mere fraction of that number, around $4700. Dexcom states every major commercial plan in California currently covers CGM technologies because they recognize the value of CGMs in improving outcomes and lowering the total cost of treating diabetes. By adding CGM systems that are medically necessary for the management and treatment of diabetes to the schedule of benefits under the Medi-Cal program, Dexcom argues this bill will help to improve the lives of Medi-Cal enrollees with diabetes.
- Policy issues.
- Which CGMs should be required? Per the CHBRP analysis, there are two types of CBMs: retrospective and real time. The retrospective CGM is used by treating providers over the course of a 72 hours to a week to provide information to the provider on the patient’s blood glucose levels, while the real-time CGM provides information to the patient throughout the day and night on blood glucose levels. Should the requirement in this bill for Medi-Cal coverage be specific to the type (retrospective vs. real-time) that is required?
- Mandating coverage for a product with a limited number of manufacturers. CHBRP indicates there are three companies that produce CGMs, two of which currently offer a retrospective monitor in the US (Dexcom and Medtronic). The third (Abbott) is submitting their retrospective monitor to the FDA for approval in the near future. When state law requires coverage of a particular drug, device or supply in Medi-Cal, there is a risk to DHCS and its contracting health plans that the manufacturer will increase the price of its product because state law would continue to require coverage. In Medi-Cal fee-for-service, DHCS conditions placement of drugs on its contract drug list (similar to a formulary) on drug manufacturers entering into a rebate agreement with the state to offset the cost of the drug. Should DHCS be given authority to condition coverage of CGMs on manufacturers entering into a rebate agreement?
- Sunset? Managing diabetes requires daily patient self-monitoring blood glucose through a finger stick. The CGMs can be used in lieu of the finger stick and offers a clinical benefit to the patient in that it monitors blood glucose continuously and provides feedback to the patient. However, just as the CGM is an improvement over the finger stick method, if treatment and monitoring improve such that CGM becomes no longer accepted part of clinical practice, should be this bill have a sunset date?
SUPPORT AND OPPOSITION:
Support: American Diabetes Association
California Academy of Family Physicians
California Academy of PAs
California Association for Health Services at Home
California Medical Association
California Optometric Association
California Health+Advocates
Central California Alliance for Health
Dexcom
Golden Valley Health Centers
In Home Supportive Services Advisory Committee San Bernardino
Livingston Community Health
Merced County Board of Supervisors
Stanford Health Care
Western Center on Law and Poverty
Several individuals
Oppose: None received
-- END --
ASSEMBLY THIRD READING
ATR Bill Id:
Author:(Gray)
As Amended Ver:May 26, 2017
Majority vote
Committee | Votes | Ayes | Noes |
Health | 15-0 | Wood, Maienschein, Bonta, Burke, Gallagher, Limón, McCarty, Nazarian, Patterson, Quirk-Silva, Ridley-Thomas, Rodriguez, Santiago, Chiu, Waldron | |
Appropriations | 16-0 | Gonzalez Fletcher, Bigelow, Bloom, Bocanegra, Bonta, Brough, Calderon, McCarty, Quirk, Fong, Friedman, Gallagher, Eduardo Garcia, Gray, Muratsuchi, Reyes |
|
SUMMARY: Provides Medi-Cal coverage for continuous glucose monitors (CGMs) when medically necessary for the management and treatment of diabetes mellitus, subject to utilization controls, and to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
FISCAL EFFECT: According to the Assembly Appropriations Committee,
- According to the California Health Benefits Review Program (CHBRP), Medi- Cal managed care cost pressure of $2.1 million (general fund (GF)/federal). Although CHBRP did not estimate utilization and cost in fee-for-service (FFS) Medi-Cal, which currently doesn't cover CGMs, staff estimates FFS expenditures in a roughly similar range based on the number of individuals enrolled in FFS Medi-Cal who would receive coverage for CGMs.
- Minor and absorbable administrative costs to Department of Health Care Services (DHCS) to update relevant provider manuals, codes, and contacts to add CMGs as a covered benefit (GF/federal).
COMMENTS: According to the author, Medi-Cal's refusal to cover CGMs discriminates against the poor who are more likely to be diagnosed with diabetes and experience complications from this chronic disease. Medi-Cal now provides health care coverage for one in three Californians and 43% of the state’s total diabetic population. Nearly every other health plan has chosen to cover CGMs, including Covered California, Medicare, and the Medicaid programs in 40 other states, but Medi-Cal refuses to provide coverage for a technology that is clinically proven to improve blood sugar management and reduce the odds of catastrophic consequences from poor diabetes management such as hypoglycemia, amputations, and blindness. The result is that California suffers extreme economic and racial disparities in healthcare outcomes among our diabetic population, and this disparity is particularly acute for economically disadvantaged Californians served by Medi-Cal, who currently undergo up to 10 times as many diabetes-related amputations as their non-Medi-Cal counterparts.
In addition to lab tests and self-monitoring blood glucose, patients and providers may also use CGM to help manage diabetes. Three manufacturers produce federal Food and Drug Administration approved CGMs in the U.S. (Abbott, Dexcom, and Medtronic). These waterproof monitors, also called continuous interstitial glucose monitors, use a thin plastic catheter inserted into the subcutaneous skin (fat layer) just under the skin of the arm, back, or trunk to measure the amount of glucose in the fluid around the cells, called interstitial fluid. CGMs have three components: the sensor is a plastic catheter (inserted with a needle) that is attached to the skin with adhesive tape; or integrated with an insulin pump, depending on the model; the transmitter attaches to the sensor and sends data wirelessly to the receiver; and, the receiver/display is optional and that can be worn on a belt or in a pocket (or can be a part of an insulin pump) for patients using a CGM in real time. Sensors are replaced within seven days, and transmitters must be recharged every three to 14 days. Many CGMs have software that enables patient use of smart devices or remote monitoring.
California Health Benefits Review Program (CHBRP) analysis. Approximately 10.8 million Californians will receive full-scope health insurance through Medi-Cal Managed Care plans (MCMC), County Organized Health System Managed Care (COHS) plans, and the FFS program in 2018 (28% of all Californians). The 7.8 million beneficiaries enrolled in MCMC plans have health insurance regulated by the Department of Managed Health Care (DMHC), while beneficiaries receiving health insurance through COHS plans and the FFS program have plans overseen by DHCS. If enacted, this bill would affect the health insurance of beneficiaries in MCMC plans, FFS program, and COHS plans. This bill does not impact privately funded DMHC or California Department of Insurance regulated plans or policies. Based on data from 2008 and 2013, the Centers for Disease Control and Prevention (CDC) estimates that diabetes costs Medi-Cal $3 billion annually in medical costs. For all payers across California, including Medi-Cal, the CDC estimates indirect costs for all patients with diabetes (e.g., absenteeism, presenteeism, household productivity loss, inability to work, and premature mortality) are $30 billion annually (2013) and direct medical costs are $20.4 billion (2013). CHBRP does not estimate that per unit costs in Medi-Cal would change due to this bill. In the absence of Medi-Cal claims data or managed care fee schedule information, and because price information from FFS is not available, CHBRP calculated a likely Medi-Cal cost per unit using MarketScan data. Based upon two separate sources on the ratio of commercial, Medicare, and Medicaid fees, CHBRP determined that the cost per unit for CGM would be approximately 46% of the commercial rates seen in MarketScan data. CHBRP assumes, on average, that rate is already being paid by the managed care plans that cover CGM and the likely cost per unit post mandate would be the same, but more beneficiaries would use CGM and have it covered by their MCMC or COHS plan or the FFS program. CHBRP estimated that CGMs would cost $280 per unit, for a total of $883 annually per user. In addition, $955 is spent on average for other supplies related to diabetes management. The mandate would not change the estimated unit cost or annual cost per user, but it would increase the number of potential users due to the increase in Medi-Cal enrollees with coverage for CGMs (9.3% in MCMC and COHS, and 100% in FFS). This bill would increase total net annual expenditures by $2.1 million (0.0075% of managed care expenditures) for MCMC plans. Enrollees would not see an increase in out-of-pocket expenditures because of the prohibition on cost sharing for low-income beneficiaries in Medi-Cal. CHBRP anticipates that MCMC and COHS plans and the FFS program would use similar prior authorization, utilization review, treatment authorization requests, and provider guidance to cover CGMs when medically necessary. Although COHS are excluded because they are not DMHC-regulated, CHBRP estimated increases in use and expenditures separately. Using the same 2015 California Health Interview Survey data used for the Medi-Cal managed care population, CHBRP estimated baseline prevalence of potential CGM users and utilization of other diabetes supplies and change post mandate. The state expenditures for Medi-Cal COHS Plans are estimated to increase by $385,000 due to 9.3% of the COHS enrollees who would gain coverage for CGM due to this bill. These impacts assume similarity (in terms of age/sex and disease prevalence, and unit cost) between beneficiaries enrolled in DMHC-plans and beneficiaries enrolled in COHS. As it is not clear how similar the circumstances of the FFS beneficiaries are to the beneficiaries enrolled in DMHC-regulated plans, CHBRP cannot estimate an impact, but presumes there would be an impact for beneficiaries receiving benefits through the FFS program. CHBRP is unable to estimate a percent change in Medi-Cal spending in the FFS program due to lack of detailed information on the budget and overall spending. In addition, because FFS is often a transitional or temporary state for pending applicants, medically indigent beneficiaries with a share of cost, emergency Medi-Cal beneficiaries, and specific carved-out groups (like California Children’s Services beneficiaries), CHBRP cannot accurately predict when beneficiaries would use these services within the year of analysis (2018). It is possible that use would occur after beneficiaries have transitioned into MCMC plans. Not every FFS group is transitioned into a managed care plan, but the complication of modeling transitions for pending applicants, retroactive claiming processes, carve-outs, and medical exceptions make it difficult to estimate the exact source of the future spending due to the mandate.
Additionally, CHBRP estimates that 90.7% of beneficiaries with MCMC coverage currently have coverage for CGMs for the treatment and management of diabetes. Conversely, 0% of beneficiaries in the FFS program have coverage for CGM for the treatment and management of diabetes.
In January 2017, the Centers for Medicare & Medicaid Services ruled therapeutic CGMs would be covered under the Durable Medical Equipment Medicare Part B benefit when "determined to be reasonable and necessary for the treatment of diabetes illness." Replacement of essential accessories for the monitor would also be covered. For Medi-Cal beneficiaries dually enrolled in Medicare (dual-eligible), Medicare is the primary payer. CHBRP assumes that cost sharing for Medicare beneficiaries using therapeutic CGMs would be covered by Medi-Cal and that Medicare beneficiaries do not have coverage for adjunctive CGMs. However, CHBRP also assumes that Medi-Cal reimbursements for CGMs are below Medicare's reimbursement, meaning Medi-Cal would not pay for a dual-eligible's cost sharing portion. Medi-Cal would be the primary payer if a dually eligible Medi-Cal/Medicare beneficiary receives a medically necessary adjunctive CGM.
The California Academy of Physician Assistants state that continuous glucose monitors are an important tool for managing all types of diabetes. Dexcom writes that California can lower spending associated with diabetes by effectively managing diabetes in the Medi-Cal population. Dexcom cites a 2015 DHCS report that noted that spending associated with adult individuals treated for diabetes totaled $3.6 billion, which is approximately 14% of the spending on non-dual eligible. Western Center on Law and Poverty states that legal aid advocates cite the need for this bill as advocates report cases of MCMC plans denying clients’ requests for CGM.
The California Association of Health Plans is requesting amendments to ensure that the cost of the CGM are included in the MCMC plan rate prior to the benefit going into effect.
Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097 0000809
Date of Hearing: May 10, 2017
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez Fletcher, Chair
ABPCA Bill Id:AB 447
Author:(Gray) – As Amended Ver:April 27, 2017
Policy Committee: | Health | Vote: | 15 - 0 |
Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill requires coverage for continuous glucose monitors (CGMs) in the Medi-Cal program for enrollees with Type 1 or Type 2 diabetes who meet specified criteria, and makes implementation of the benefit contingent on federal financial participation and necessary federal approvals.
FISCAL EFFECT:
- According to the California Health Benefits Review Program (CHBRP), Medi-Cal managed care cost pressure of $2.1 million (GF/federal). Although CHBRP did not estimate utilization and cost in fee-for-service (FFS) Medi-Cal, which currently doesn't cover CGMs, staff estimates FFS expenditures in a roughly similar range based on the number of individuals enrolled in FFS Medi-Cal who would receive coverage for CGMs.
- Minor and absorbable administrative costs to Department of Health Care Services to update relevant provider manuals, codes, and contacts to add CMGs as a covered benefit (GF/federal).
COMMENTS:
- Purpose. This bill adds CGMs as a Medi-Cal covered benefit in order to align Medi-Cal with most commercial payers and ensure vulnerable patients who need these devices can access them.
- Background. Diabetes requires regular monitoring of glucose levels. The most common method is fingerstick testing, in which a small drop of blood is taken from the finger and placed on a test strip, which is measured by a handheld device called a glucometer. According to the National Institutes of Health, CGM systems, instead, use a tiny sensor inserted under the skin to check glucose levels in tissue fluid. The sensor stays in place for several days to a week and then must be replaced. A transmitter sends information about glucose levels via radio waves from the sensor to a pagerlike wireless monitor. The monitors are more expensive than traditional "fingerstick" blood glucose tests, and are not yet as widely used.
- CHBRP Report. CHBRP reports evidence of effectiveness of CGMs is strongest for real-time use by Type 1 diabetes patients, which shows clear and convincing evidence of improved glycemic control (with consistent CGM adherence). With respect to Type 2 diabetes, CHBRP reports limited evidence that real-time use of CGMs are not effective for patients with type 2 diabetes, and no evidence of effectiveness.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
Date of Hearing: April 25, 2017
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
ABPCA Bill Id:AB 447
Author:(Gray) – As Introduced Ver:February 13, 2017
SUBJECT: Medi-Cal: covered benefits: continuous glucose monitors.
SUMMARY: Provides Medi-Cal coverage for continuous glucose monitors (CGMs) when medically necessary for the management and treatment of type 1 (T1DM), type 2 (T2DM), and gestational diabetes (GDM) to the extent that federal financial participation is available and any necessary federal approvals have been obtained.
EXISTING LAW:
- Establishes the Medi-Cal Program, administered by the Department of Health Care Services (DHCS), to provide comprehensive health benefits to low-income individuals who meet specified eligibility criteria.
- Establishes a schedule of benefits under the Medi-Cal program, which includes federally required and optional Medicaid benefits, including durable medical equipment and medical supplies, subject to utilization controls and coverage of diabetic test supplies when provided by a pharmacy.
- Establishes the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act), which provides for the licensure and regulation of health care service plans by the Department of Managed Health Care (DMHC).
- Requires health care service plans to cover diabetes education, management, and treatment under the Knox-Keene Act.
- Establishes the California Children’s Services (CCS), which provides diagnostic and treatment services, medical case management, and physical and occupational therapy services to children under age 21 with CCS-eligible medical conditions and is administered as a partnership between county health departments and DHCS.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.
COMMENTS:
- PURPOSE OF THIS BILL. According to the author, Medi-Cal’s refusal to cover CGMs discriminates against people of color and the poor who are more likely to be diagnosed with diabetes and experience complications from this chronic disease. Medi-Cal now provides health care coverage for one in three Californians and 43% of the state’s total diabetic population. Nearly every other health plan has chosen to cover CGMs, including Covered California, Medicare, and the Medicaid programs in 40 other states, but Medi-Cal refuses to provide coverage for a technology that is clinically proven to improve blood sugar management and reduce the odds of catastrophic consequences from poor diabetes management such as hypoglycemia, amputations, and blindness. The result is that California suffers extreme economic and racial disparities in healthcare outcomes among our diabetic population, and this disparity is particularly acute for economically disadvantaged Californians served by Medi-Cal, who currently undergo up to 10 times as many diabetes-related amputations as their non-Medi-Cal counterparts.
- BACKGROUND. Diabetes mellitus (DM) is a chronic disease with short and long-term health effects that prevent the proper production of and/or response to insulin, a hormone that facilitates the transfer of glucose into cells to provide energy. Diabetes is one of the most common chronic conditions in California and the United States. According to the 2015 California Health Interview Survey (CHIS), about 11% of the adult Medi-Cal population has been diagnosed with diabetes, as compared with about 6% of the privately insured, adult California population. There are three primary types of diabetes: T1DM; T2DM; and, GDM.
In addition to lab tests and self-monitoring blood glucose, patients and providers may also use CGM to help manage diabetes. Three manufacturers produce federal Food and Drug Administration approved CGMs in the U.S. (Abbott, Dexcom, and Medtronic). These waterproof monitors, also called continuous interstitial glucose monitors, use a thin plastic catheter inserted into the subcutaneous skin (fat layer) just under the skin of the arm, back, or trunk to measure the amount of glucose in the fluid around the cells, called interstitial fluid. CGMs have three components: the sensor is a plastic catheter (inserted with a needle) that is attached to the skin with adhesive tape; or integrated with an insulin pump, depending on the model; the transmitter attaches to the sensor and sends data wirelessly to the receiver; and, the receiver/display is optional and that can be worn on a belt or in a pocket (or can be a part of an insulin pump) for patients using a CGM in real time. Sensors are replaced within seven days, and transmitters must be recharged every three to 14 days. Many CGMs have software that enables patient use of smart devices or remote monitoring.
- California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson), Chapter 795, Statutes of 2002, requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996. SB 125 (Hernandez), Chapter 9, Statutes of 2015, added an impact assessment on essential health benefits, and legislation that impacts health insurance benefit designs, cost sharing, premiums, and other health insurance topics. The Committee requested a CHBRP analysis on this bill which indicates the following:
- Enrollees Covered. Approximately 10.8 million Californians will receive full-scope health insurance through Medi-Cal Managed Care plans (MCMC), County Organized Health System Managed Care (COHS) plans, and the fee-for-service (FFS) program in 2018 (28% of all Californians). The 7.8 million beneficiaries enrolled in MCMC plans have health insurance regulated by the DMHC, while beneficiaries receiving health insurance through COHS plans and the FFS program have plans overseen by DHCS. If enacted, this bill would affect the health insurance of beneficiaries in MCMC plans, FFS program, and COHS plans. This bill does not impact privately funded DMHC or California Department of Insurance (CDI) regulated plans or policies.
- Impact on expenditures. Based on data from 2008 and 2013, the Centers for Disease Control and Prevention (CDC) estimates that diabetes costs Medi-Cal $3 billion annually in medical costs. For all payers across California, including Medi-Cal, the CDC estimates indirect costs for all patients with diabetes (e.g., absenteeism, presenteeism, household productivity loss, inability to work, and premature mortality) are $30 billion annually (2013) and direct medical costs are $20.4 billion (2013).
- California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson), Chapter 795, Statutes of 2002, requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996. SB 125 (Hernandez), Chapter 9, Statutes of 2015, added an impact assessment on essential health benefits, and legislation that impacts health insurance benefit designs, cost sharing, premiums, and other health insurance topics. The Committee requested a CHBRP analysis on this bill which indicates the following:
CHBRP does not estimate that per unit costs in Medi-Cal would change due to this bill. In the absence of Medi-Cal claims data or managed care fee schedule information, and because price information from FFS is not available, CHBRP calculated a likely Medi-Cal cost per unit using MarketScan data. Based upon two separate sources on the ratio of commercial, Medicare, and Medicaid fees, CHBRP determined that the cost per unit for CGM would be approximately 46% of the commercial rates seen in MarketScan data. CHBRP assumes, on average, that rate is already being paid by the managed care plans that cover CGM and the likely cost per unit post mandate would be the same, but more beneficiaries would use CGM and have it covered by their MCMC or COHS plan or the FFS program. CHBRP estimated that CGMs would cost $280 per unit, for a total of $883 annually per user. In addition, $955 is spent on average for other supplies related to diabetes management. The mandate would not change the estimated unit cost or annual cost per user, but it would increase the number of potential users due to the increase in Medi-Cal enrollees with coverage for CGMs (9.3% in MCMC and COHS, and 100% in FFS). This bill would increase total net annual expenditures by $2.1 million (0.0075% of managed care expenditures) for MCMC plans.
Enrollees would not see an increase in out-of-pocket expenditures because of the prohibition on cost sharing for low-income beneficiaries in Medi-Cal. CHBRP anticipates that MCMC and COHS plans and the FFS program would use similar prior authorization, utilization review, treatment authorization requests, and provider guidance to cover CGMs when medically necessary. Although COHS are excluded because they are not DMHC-regulated, CHBRP estimated increases in use and expenditures separately. Using the same CHIS survey data used for the Medi-Cal managed care population, CHBRP estimated baseline prevalence of potential CGM users and utilization of other diabetes supplies and change post mandate. The state expenditures for Medi-Cal COHS Plans are estimated to increase by $385,000 due to 9.3% of the COHS enrollees who would gain coverage for CGM due to this bill. These impacts assume similarity (in terms of age/sex and disease prevalence, and unit cost) between beneficiaries enrolled in DMHC-plans and beneficiaries enrolled in COHS. As it is not clear how similar the circumstances of the FFS beneficiaries are to the beneficiaries enrolled in DMHC-regulated plans, CHBRP cannot estimate an impact, but presumes there would be an impact for beneficiaries receiving benefits through the FFS program. CHBRP is unable to estimate a percent change in Medi-Cal spending in the FFS program due to lack of detailed information on the budget and overall spending. In addition, because FFS is often a transitional or temporary state for pending applicants, medically indigent beneficiaries with a share of cost, emergency Medi-Cal beneficiaries, and specific carved-out groups (like California Children’s Services beneficiaries), CHBRP cannot accurately predict when beneficiaries would use these services within the year of analysis (2018). It is possible that use would occur after beneficiaries have transitioned into MCMC plans. Not every FFS group is transitioned into a managed care plan, but the complication of modeling transitions for pending applicants, retroactive claiming processes, carve-outs, and medical exceptions make it difficult to estimate the exact source of the future spending due to the mandate.
- Essential Health Benefits (EHBs). This bill would not require coverage for a new state benefit mandate within the state-regulated private market and therefore will not exceed the definition of EHBs in California.
- Medical effectiveness. Evidence of effectiveness of CGMs is strongest for real-time use by T1DM patients, which shows clear and convincing evidence of improved glycemic control (HbA1c) (with consistent CGM adherence). Overall, there is limited evidence that use of real-time CGMs for patients with T1DM is effective. A preponderance of evidence found the use of retrospective CGMs for patients with T1DM are not effective. There is limited evidence that retrospective and real-time use of CGMs is not effective for patients with T2DM. Evidence is limited for retrospective CGM and insufficient for real-time CGM for improving glucose levels or maternal pregnancy or infant health outcomes for women with GDM.
- Benefit coverage. CHBRP estimates that 90.7% of beneficiaries with MCMC coverage currently have coverage for CGMs for the treatment and management of diabetes. Conversely, 0% of beneficiaries in the FFS program have coverage for CGM for the treatment and management of diabetes. In comparison, all of the commercial DMHC-regulated and CDI-regulated health plans in California who responded to CHBRP’s survey reported covering the use of CGM for treatment and management of diabetes. It is unclear whether CGMs are currently covered for children under age 21 enrolled in Medi-Cal through the Early Periodic Screening, Diagnostic, and Treatment (EPSDT) Program. CHBRP assumes that CGMs are covered for children according to the MCMC plan’s benefits.
At baseline, 3.979 CGMs are estimated to be used per 1,000 enrollees in Medi-Cal, regardless of the type of coverage (MCMC, COHS, or FFS). Due to the addition of CGM coverage for 9.3% of beneficiaries in Medi-Cal managed care plans, the postmandate use of CGM is estimated to be 4.386 per 1,000 beneficiaries. This represents a 10.2% increase in CGM use by MCMC plan beneficiaries due to the mandate. CHBRP estimates that use of CGMs would increase to 4.386 per 1,000 enrollees in both COHS plans and the FFS program. CHBRP is unable to separate spending for real-time or retrospective use of CGMs in the MarketScan claims data used so the two types of CGM are combined in the cost analysis. Also, despite not being able to explicitly estimate discontinuation of CGMs due to the use of claims data (which cannot capture patient discontinuation, misuse, or variation in use of the device), the utilization estimates are based upon actual experience in the commercial market (via MarketScan data), which would include these types of patient behaviors and experiences with CGM.
- Utilization. According to CHBRP, 3.979 CGMs are estimated to be used per 1,000 beneficiaries in Medi-Cal, regardless of the type of coverage (MCMC, COHS, or FFS). Due to the addition of CGM coverage for 9.3% of beneficiaries in MCMC plans, the postmandate use of CGMs is estimated to be 4.386 per 1,000 beneficiaries. This represents a 10.2% increase in CGM use by MCMC beneficiaries due to the mandate. CHBRP estimates that use of CGMs would increase to 4.386 per 1,000 enrollees in both COHS plans and the FFS program.
- Public Health. Patients most likely to benefit from use of CGMs include those over age 24 years (or selected children, teens, or young adults) who are insulin dependent and/or have hypoglycemic unawareness. In the first year postmandate, CHBRP projects that the 2,255 additional CGM users, who use the CGM consistently, would see improvements in glycemic control as compared with self-monitoring blood glucose testing alone. This estimate is supported by a preponderance of evidence that CGMs are medically effective for those insulin-dependent patients and those who are hypoglycemia unaware, and who are able to maintain adequate adherence to CGM.
In the first year postmandate, CHBRP projects a reduction in statewide disparities, increasing access to CGMs for low and middle-to-high income patients with diabetes by bringing Medi-Cal coverage of CGMs into parity with that of the privately insured population. Thus, the opportunity for better glycemic management among those low-income individuals who access and consistently use the newly covered CGMs would improve. The use of CGMs is associated with improved blood sugar control, but there is no or limited evidence that CGM use directly led to improved clinical outcomes, reduced emergency room or inpatient use, or cost savings when compared to the current standard of care (i.e., self- monitoring without CGMs) over 12 months or shorter periods of time.
- Long-term impacts. There is insufficient evidence around long-term CGM use and cost savings, and CHBRP does not anticipate differences, over time, that are different from the short-term estimates.
The impact on DM-related-comorbidities and premature mortality is unknown due to the lack of evidence regarding long-term health outcomes of CGM use. However, well-controlled blood glucose results in less DM-related comorbidity (blindness, amputations, kidney disease, etc.). Therefore, for those patients who attain good glycemic control through a CGM, these DM-related comorbidities that are known to lead to premature death could be prevented, delayed, or ameliorated.
- Other states and federal law. CHBRP is aware of at least one state Medicaid program that currently provides coverage for CGMs. Indiana Health Coverage Programs reimburses for use of retrospective and real-time CGMs for adults and children (aged seven and above) when the service is considered medically necessary, although the Provider Reference Model does not indicate whether CGMs are covered for T1DM, T2DM, or GDM. In January 2017, the Centers for Medicare & Medicaid Services (CMS) ruled therapeutic CGMs would be covered under the Durable Medical Equipment (DME) Medicare Part B benefit when “determined to be reasonable and necessary for the treatment of diabetes illness.” Replacement of essential accessories for the monitor would also be covered. For Medi-Cal beneficiaries dually enrolled in Medicare (dual-eligibles), Medicare is the primary payer. CHBRP assumes that cost sharing for Medicare beneficiaries using therapeutic CGMs would be covered by Medi-Cal and that Medicare beneficiaries do not have coverage for adjunctive CGMs. However, CHBRP also assumes that Medi-Cal reimbursements for CGMs are below Medicare’s reimbursement, meaning Medi-Cal would not pay for a dual-eligible’s cost sharing portion. Medi-Cal would be the primary payer if a dually eligible Medi-Cal/Medicare beneficiary receives a medically necessary adjunctive CGM.
- CCS. CGMs are required to be covered for children receiving coverage through CCS. As of 2017, the CCS program is operated as a FFS carve-out in most counties in California, meaning that children receiving Medi-Cal through the MCMC plans or COHS receive additional coverage for qualifying diseases or conditions through a FFS financing component that is separate from their general Medi-Cal coverage. Currently, five COHS counties are “carved-in” CCS counties: Napa, San Mateo, Santa Barbara, Solano, and Yolo. Diabetes is a CCS-qualifying disease, but management of diabetes may be done via the CCS carve-out (delivered through CCS special care centers or children's hospital providers) or through a child's assigned managed care plan or COHS coverage via a non-CCS provider.
The number of children and adults with CCS-only coverage who will obtain all diabetes care through the FFS Medi-Cal system because they have no additional Medi-Cal managed care coverage is relatively small. In 2012, there were approximately 190,500 children receiving benefits through CCS, and 4% were diagnosed with DM. Some of these children with DM could have received a CGM, either through the CCS carve out or through the MCMC plan or COHS. In either case, the CGM is a currently covered benefit. This small number of children (less than 1%) who would have had coverage in both the CCS program and their managed care or COHS plans is unlikely to have a meaningful effect on the utilization or expenditure estimates in this report. If the current level of use of CGM in the FFS carve-out is relatively high, CHBRP would be overestimating the spending on CGM due to new coverage. Given the overlap in coverage for CCS patients who obtain services partially through the FFS program and their COHS or managed care plan, it is likely that most of these enrollees are captured in the COHS and managed care plans due to their full-scope Medi-Cal coverage; CHBRP does not think an overestimate of new coverage is likely. DHCS is currently transitioning the CCS population to a “whole child model”, which would move at least 25,000 CCS enrollees into COHS “carved-in” programs during 2017. The remainder may transition from 2018 to 2021.
- SUPPORT. The California Academy of PAs state that continuous glucose monitors are an important tool for managing all types of diabetes. Dexcom writes that California can lower spending associated with diabetes by effectively managing diabetes in the Medi-Cal population. Dexcom cites a 2015 DHCS report that noted that spending associated with adult individuals treated for diabetes totaled $3.6 billion, which is approximately 14% of the spending on non-dual eligible. Western Center on Law and Poverty states that legal aid advocates cite the need for this bill as advocates report cases of MCMC plans denying clients’ requests for CGM.
- OPPOSE UNLESS AMENDED. The California Association of Health Plans is requesting amendments to ensure that the cost of the CGM are included in the MCMC plan rate prior to the benefit going into effect.
- PREVIOUS LEGISLATION. SB 64 (Solis), Chapter 540, Statutes of 1999, requires all policies and plans, except as specified, issued, amended, delivered, or renewed on and after January 1, 2000, that cover hospital, medical, or surgical expenses, to provide coverage for specified equipment and supplies for the management and treatment of diabetes as medically necessary. Also requires those policies and plans that cover prescription drugs to also include specified prescription medications for the treatment of diabetes if the items are determined to be medically necessary. Requires all policies and plans to provide self-management training, education, and medical nutrition therapy.
- AUTHOR’S AMENDMENTS. This bill requires coverage of CGMs that are medically necessary for the management and treatment of diabetes, including DM1, DM2, and GDM. The author intends to narrow this bill to apply to the following
- For treatment of DM1 when medically necessary and when all of the following criteria are satisfied:
- The beneficiary is insulin-treated with multiple daily injections of insulin or a continuous subcutaneous insulin infusion pump; and,
- The beneficiary’s insulin treatment regimen requires frequent adjustment.
- For treatment of DM2 when medically necessary and when all of the following criteria are satisfied:
- The beneficiary is insulin treated with multiple daily injections of insulin or a continuous subcutaneous insulin infusion with hypoglycemia unawareness;
- The beneficiary has been using a home blood glucose monitor and performing frequent blood glucose monitor testing four or more times a day; and,
- The beneficiary’s insulin treatment regimen requires frequent adjustment.
- For treatment of DM1 when medically necessary and when all of the following criteria are satisfied:
REGISTERED SUPPORT / OPPOSITION:
Support
David Geffen School of Medicine at UCLA
California Academy of Pas
California Academy of Family Physicians
California Association for Health Services at Home
California Life Sciences Association
California Optometric Association
Central California Alliance for Health
Dexcom
Stanford Health Care
UCLA Department of Medicine, Santa Monica Diabetes Center
University of California San Diego, Veterans Affairs Medical Center
Western Center on Law and Poverty
Opposition
None on file.
Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097
Discussed in Hearing
1MIN
Assembly Floor
5MIN
Senate Floor
1H
Senate Standing Committee on Appropriations
16MIN
Senate Standing Committee on Health
3MIN
Assembly Floor
1H
Assembly Standing Committee on Appropriations
15MIN
Assembly Standing Committee on Health
Bill Author
