AB 1739: Medi-Cal: allergy testing.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2016-08-25
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 and funded by federal Medicaid Program provisions. Existing law provides for a schedule of benefits under the Medi-Cal program, and authorizes the use of utilization controls, including prior authorization, that may be applied to those covered benefits and that are reviewed for, among other things, medical necessity. Under the Medi-Cal program, a service is medically necessary or a medical necessity when it is reasonable and necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain.
This bill would require the standard of coverage and medical necessity for allergy tests to be consistent with specified consensus standards and recommendations and peer-reviewed medical literature pertaining to the utilization of modern serologic-specific IgE tests. The bill would require the department to update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
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 and funded by federal Medicaid Program provisions. Existing law provides for a schedule of benefits under the Medi-Cal program, and authorizes the use of utilization controls, including prior authorization, that may be applied to those covered benefits and that are reviewed for, among other things, medical necessity. Under the Medi-Cal program, a service is medically necessary or a medical necessity when it is reasonable and necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain.
This bill would require the department to treat serologic-specific IgE allergy tests and percutaneous skin allergy tests as equivalent in their clinical efficacy for confirming the existence of an allergy in a patient, and to provide the same standard of coverage for either test for those individuals with a medical history consistent with specified conditions. standard of coverage and medical necessity for allergy tests to be consistent with specified consensus standards and recommendations and peer-reviewed medical literature pertaining to the utilization of modern serologic-specific IgE tests. The bill would require the department to update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
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 and funded by federal Medicaid Program provisions. Existing law provides for a schedule of benefits under the Medi-Cal program, and authorizes the use of utilization controls, including prior authorization, that may be applied to those covered benefits and that are reviewed for, among other things, medical necessity. Under the Medi-Cal program, a service is medically necessary or a medical necessity when it is reasonable and necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain.
This bill would require the department to treat serologic-specific IgE allergy tests and percutaneous skin allergy tests as equivalent in their sensitivity and accuracy clinical efficacy for confirming the existence of an allergy in a patient, and to provide the same standard of coverage for either test for those individuals with a medical history consistent with specified conditions. The bill would require the department to update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
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 and funded by federal Medicaid Program provisions. Existing law provides for a schedule of benefits under the Medi-Cal program, and authorizes the use of utilization controls, including prior authorization, that may be applied to those covered benefits and that are reviewed for, among other things, medical necessity. Under the Medi-Cal program, a service is medically necessary or a medical necessity when it is reasonable and necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain.
This bill would require the department to treat serologic-specific IgE allergy tests and percutaneous skin allergy tests as equivalent in their sensitivity and accuracy for confirming the existence of an allergy in a patient, and to treat those tests as medically necessary provide the same standard of coverage for either test for those individuals with a medical history consistent with specified conditions. The bill would require the department to update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
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 and funded by federal Medicaid Program provisions. Existing law provides for a schedule of benefits under the Medi-Cal program, and authorizes the use of utilization controls, including prior authorization, that may be applied to those covered benefits and that are reviewed for, among other things, medical necessity. Under the Medi-Cal program, a service is medically necessary or a medical necessity when it is reasonable and necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain.
This bill would require the department to treat serologic-specific IgE allergy tests and percutaneous skin allergy tests as equivalent in their sensitivity and accuracy for confirming the existence of an allergy in a patient, and to treat those tests as medically necessary for those individuals with a medical history consistent with specified conditions. The bill would require the department to update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
Existing law requires all electric utilities to develop a standard contract or tariff providing for net energy metering, and to make this contract available to eligible customer generators, upon request, except as provided. Existing law requires the Public Utilities Commission to complete a study by October 1, 2013, to determine who benefits from, and who bears the economic burden, if any, of the net energy metering program, and to determine the extent to which each class of ratepayers and each region of the state receiving service under the net energy metering program is paying the full cost of the services provided to them by electrical corporations, and the extent to which those customers pay their share of the costs of public purpose programs. Existing law requires the commission to report the results of the study to the Legislature within 30 days of its completion.
This bill would make a nonsubstantive change to this provision.
Existing law requires all electric utilities to develop a standard contract or tariff providing for net energy metering, and to make this contract available to eligible customer generators, upon request, except as provided. Existing law requires the Public Utilities Commission to complete a study by October 1, 2013, to determine who benefits from, and who bears the economic burden, if any, of the net energy metering program, and to determine the extent to which each class of ratepayers and each region of the state receiving service under the net energy metering program is paying the full cost of the services provided to them by electrical corporations, and the extent to which those customers pay their share of the costs of public purpose programs. Existing law requires the commission to report the results of the study to the Legislature within 30 days of its completion.
This bill would make a nonsubstantive change to this provision.
(a)The standard of coverage and medical necessity for allergy tests shall be consistent with consensus standards and recommendations in clinical guidelines from the National Institutes of Health, Clinical and Laboratory Standards Institute, and the most current peer-reviewed medical literature pertaining to the utilization of modern serologic-specific IgE tests.
(b)The department shall update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
(a)The department shall treat serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in their clinical efficacy, and shall provide the same standard of coverage for either test for those individuals with a medical history consistent with any of the following: standard of coverage and medical necessity for allergy tests shall be consistent with consensus standards and recommendations in clinical guidelines from the National Institutes of Health, Clinical and Laboratory Standards Institute, and the most current peer-reviewed medical literature pertaining to the utilization of modern serologic-specific IgE tests.
(1)An inhalant allergy.
(2)A food allergy.
(3)Hymenoptera venom allergy or an allergy to stinging insects.
(4)Allergic bronchopulmonary aspergillosis (ABPA).
(5)Certain parasitic diseases.
(6)Allergies to specific drugs.
(b)The department shall update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
(a)The department shall treat serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in terms of their sensitivity and accuracy, their clinical efficacy, and shall provide the same standard of coverage for either test for those individuals with a medical history consistent with any of the following:
(1)An inhalant allergy.
(2)A food allergy.
(3)Hymenoptera venom allergy or an allergy to stinging insects.
(4)Allergic bronchopulmonary aspergillosis (ABPA).
(5)Certain parasitic diseases.
(6)Allergies to specific drugs.
(b)The department shall update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
The Legislature finds and declares all of the following:
(a)Historically, allergies were diagnosed by an allergist who used a percutaneous, or skin-prick, test to infect the skin of a patient with varying allergens for the purpose of determining the patients reaction to those allergens. This procedure required the patient to be referred by his or her primary care physician to an allergist, and required the patient to undergo a series of pricks to his or her skin.
(b)Advances in blood testing technology using serologic-specific IgE quantitative testing allow a patient to be diagnosed without a referral to a specialist.
(c)Professional literature and guidance from the National Heart, Lung, and Blood Institute at the National Institutes of Health has determined that blood tests and skin tests for allergies are equal in their diagnostic value, and that blood testing is preferred in the case of testing for food allergies.
(d)Private health care insurance plans recognize the professional literature and guidelines regarding the efficacy of blood testing and cover blood testing for the diagnosis of allergies.
(e)Medi-Cal does not cover blood testing for allergies in the same manner as private health care insurance.
(f)Fee-for-service Medi-Cal patients are not receiving the same level of care as patients with private health insurance coverage. Due to an insufficient number of allergists available to diagnose and treat Medi-Cal patients, the diagnosis of many patients covered by Medi-Cal is delayed or never occurs.
(g)Medi-Cal coverage decisions must be based on the latest and most current medical literature and studies.
SEC. 2.SECTION 1.Section 14133.75 is added to the Welfare and Institutions Code, to read:14133.75.(a)The department shall treat serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in terms of their sensitivity and accuracy, and shall treat them as medically necessary provide the same standard of coverage for either test for those individuals with a medical history consistent with any of the following:
(1)An inhalant allergy.
(2)A food allergy.
(3)Hymenoptera venom allergy or an allergy to stinging insects.
(4)Allergic bronchopulmonary aspergillosis (ABPA).
(5)Certain parasitic diseases.
(6)Allergies to specific drugs.
(b)The department shall update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
The Legislature finds and declares all of the following:
(a)Historically, allergies were diagnosed by an allergist who used a percutaneous, or skin-prick, test to infect the skin of a patient with varying allergens for the purpose of determining the patients reaction to those allergens. This procedure required the patient to be referred by his or her primary care physician to an allergist, and required the patient to undergo a series of pricks to his or her skin.
(b)Advances in blood testing technology using serologic-specific IgE quantitative testing allow a patient to be diagnosed without a referral to a specialist.
(c)Professional literature and guidance from the National Heart, Lung, and Blood Institute at the National Institutes of Health has determined that blood tests and skin tests for allergies are equal in their diagnostic value, and that blood testing is preferred in the case of testing for food allergies.
(d)Private health care insurance plans recognize the professional literature and guidelines regarding the efficacy of blood testing and cover blood testing for the diagnosis of allergies.
(e)Medi-Cal does not cover blood testing for allergies in the same manner as private health care insurance.
(f)Fee-for-service Medi-Cal patients are not receiving the same level of care as patients with private health insurance coverage. Due to an insufficient number of allergists available to diagnose and treat Medi-Cal patients, the diagnosis of many patients covered by Medi-Cal is delayed or never occurs.
(g)Medi-Cal coverage decisions must be based on the latest and most current medical literature and studies.
SEC. 2.Section 14133.75 is added to the Welfare and Institutions Code, to read:14133.75.(a)The department shall treat serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in terms of their sensitivity and accuracy, and shall treat them as medically necessary for those individuals with a medical history consistent with any of the following:
(1)An inhalant allergy.
(2)A food allergy.
(3)Hymenoptera venom allergy or an allergy to stinging insects.
(4)Allergic bronchopulmonary aspergillosis (ABPA).
(5)Certain parasitic diseases.
(6)Allergies to specific drugs.
(b)The department shall update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
SECTION 1.Section 2827.3 of the Public Utilities Code is amended to read:2827.3.(a)By October 1, 2013, the commission shall complete a study to determine who benefits from, and who bears the economic burden, if any, of, the net energy metering program authorized pursuant to Section 2827, and to determine the extent to which each class of ratepayers and each region of the state receiving service under the net energy metering program is paying the full cost of the services provided to them by electrical corporations, and the extent to which those customers pay their share of the costs of public purpose programs. In evaluating program costs and benefits for purposes of the study, the commission shall consider all electricity generated by renewable electric generating systems, including the electricity used onsite to reduce a customers consumption of electricity that otherwise would be supplied through the electrical grid, as well as the electrical output that is being fed back to the electrical grid for which the customer receives credit or net surplus electricity compensation under net energy metering. The study shall quantify the costs and benefits of net energy metering to participants and nonparticipants and shall further disaggregate the results by utility, customer class, and household income groups within the residential class. The study shall further gather and present data on the income distribution of residential net energy metering participants. In order to assess the costs and benefits at various levels of net energy metering implementation, the study shall be conducted using multiple net energy metering penetration scenarios, including, at a minimum, the capacity needed to reach the solar photovoltaic goals of the California Solar Initiative pursuant to Section 25780 of the Public Resources Code, and the estimated net energy metering capacity under the 5-percent minimum requirement of paragraphs (1) and (4) of subdivision (c) of Section 2827.
(b)(1)The commission shall report the results of the study to the Legislature within 30 days of the studys completion.
(2)The report shall be submitted in compliance with Section 9795 of the Government Code.
(3)Pursuant to Section 10231.5 of the Government Code, this section is repealed on July 1, 2017.
(a)By October 1, 2013, the commission shall complete a study to determine who benefits from, and who bears the economic burden, if any, of, the net energy metering program authorized pursuant to Section 2827, and to determine the extent to which each class of ratepayers and each region of the state receiving service under the net energy metering program is paying the full cost of the services provided to them by electrical corporations, and the extent to which those customers pay their share of the costs of public purpose programs. In evaluating program costs and benefits for purposes of the study, the commission shall consider all electricity generated by renewable electric generating systems, including the electricity used onsite to reduce a customers consumption of electricity that otherwise would be supplied through the electrical grid, as well as the electrical output that is being fed back to the electrical grid for which the customer receives credit or net surplus electricity compensation under net energy metering. The study shall quantify the costs and benefits of net energy metering to participants and nonparticipants and shall further disaggregate the results by utility, customer class, and household income groups within the residential class. The study shall further gather and present data on the income distribution of residential net energy metering participants. In order to assess the costs and benefits at various levels of net energy metering implementation, the study shall be conducted using multiple net energy metering penetration scenarios, including, at a minimum, the capacity needed to reach the solar photovoltaic goals of the California Solar Initiative pursuant to Section 25780 of the Public Resources Code, and the estimated net energy metering capacity under the 5-percent minimum requirement of paragraphs (1) and (4) of subdivision (c) of Section 2827.
(b)(1)The commission shall report the results of the study to the Legislature within 30 days of its the studys completion.
(2)The report shall be submitted in compliance with Section 9795 of the Government Code.
(3)Pursuant to Section 10231.5 of the Government Code, this section is repealed on July 1, 2017.
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Date
|
Status
|
|---|---|
| Jun 2, 2016 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on HEALTH. |
| Aug 30, 2016 | Enrolled and presented to the Governor at 4 p.m. |
| Aug 23, 2016 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 80. Noes 0. Page 6159.). |
| Aug 23, 2016 | Senate amendments concurred in. To Engrossing and Enrolling. |
| Aug 19, 2016 | In Assembly. Concurrence in Senate amendments pending. May be considered on or after August 21 pursuant to Assembly Rule 77. |
| Aug 18, 2016 | Read third time. Passed. Ordered to the Assembly. (Ayes 36. Noes 0.). |
| Aug 18, 2016 | Read third time. Passed. Ordered to the Assembly. (Ayes 36. Noes 0. Page 5134.). |
| Aug 18, 2016 | Read third time. Passed. Ordered to the Assembly. |
| Aug 15, 2016 | Read second time. Ordered to third reading. |
| Aug 11, 2016 | From committee: Do pass. (Ayes 7. Noes 0.) (August 11). |
| Aug 8, 2016 | Referred to APPR. suspense file. |
| Aug 2, 2016 | Read second time and amended. Re-referred to Com. on APPR. |
| Aug 1, 2016 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 8. Noes 0.) (June 29). |
| Jun 9, 2016 | In committee: Set, first hearing. Hearing canceled at the request of author. |
| Feb 1, 2016 | Read first time. To print. |
| May 12, 2016 | Referred to Com. on HEALTH. |
| May 5, 2016 | Read third time. Passed. Ordered to the Senate. (Ayes 79. Noes 0. Page 4684.) |
| May 5, 2016 | Read third time. Passed. Ordered to the Senate. |
| May 5, 2016 | In Senate. Read first time. To Com. on RLS. for assignment. |
| Apr 28, 2016 | Read second time. Ordered to Consent Calendar. |
| Apr 27, 2016 | From committee: Do pass. To Consent Calendar. (Ayes 19. Noes 0.) (April 27). |
| Apr 20, 2016 | Re-referred to Com. on APPR. |
| Apr 19, 2016 | Read second time and amended. |
| Apr 18, 2016 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 18. Noes 0.) (April 12). |
| Mar 17, 2016 | Re-referred to Com. on HEALTH. |
| Mar 16, 2016 | From committee chair, with author's amendments: Amend, and re-refer to Com. on HEALTH. Read second time and amended. |
| Mar 14, 2016 | Referred to Com. on HEALTH. |
| Feb 2, 2016 | From printer. May be heard in committee March 3. |
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Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 23, 2016 | AB 1739 WALDRON Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Aug 18, 2016 | Assembly 3rd Reading AB1739 Waldron By Pan | Senate Floor |
Passed |
|
| Aug 11, 2016 | Do pass | Senate Standing Committee on Appropriations |
Passed |
|
| Aug 8, 2016 | Placed on suspense file | Senate Standing Committee on Appropriations |
Passed |
|
| Jun 29, 2016 | Do pass as amended, but first amend, and re-refer to the Committee on [Appropriations] | Senate Standing Committee on Health |
Passed |
|
| May 5, 2016 | AB 1739 WALDRON Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| Apr 27, 2016 | Do pass. To Consent Calendar. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 12, 2016 | 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 Federation Of State, County And Municipal Employees, Afl-Cio | ** Support | Aug 18, 2016 |
| California Health+ Advocates | ** Support | Aug 18, 2016 |
| California Life Sciences Association | ** Support | Aug 18, 2016 |
| Department Of Finance | ** Against | Aug 18, 2016 |
| Department of Health Care Services | ** Against | Aug 18, 2016 |
| Miller Children's Hospital | ** Support | Apr 12, 2016 |
| One individual | ** Support | Aug 18, 2016 |
| Phadia Us Inc., A Part Of Thermo Fisher Scientific | * Support | Jun 29, 2016 |
| Sansum Clinic | * Support | Jun 29, 2016 |
| Thermo-Fisher Scientific | ** Support | Aug 18, 2016 |
| University of California San Diego | * Support | Jun 29, 2016 |
GOVERNOR'S VETO
GV Bill Id:AB 1739
Author:(Waldron)
As Enrolled Ver:August 30, 2016
2/3 vote
ASSEMBLY: | 79-0 | (May 5, 2016) | SENATE: | 36-0 | (August 18, 2016) |
ASSEMBLY: | 80-0 | (August 23, 2016) |
Original Committee Reference: HEALTH
SUMMARY: Requires the standard of coverage and medical necessity for allergy tests to be consistent with consensus standards and recommendations in clinical guidelines from the National Institutes of Health, Clinical and Laboratory Standards Institute, and the most current peer-reviewed medical literature pertaining to the utilization of modern serologic-specific immunoglobulin E (IgE) tests, as specified.
FISCAL EFFECT: According to the Senate Appropriations Committee, likely increased Medi-Cal costs in the hundreds of thousands per year (General Fund and federal funds). The fiscal impact of the bill is subject to some uncertainty. Department of Healthcare Services (DHCS) indicates that under the bill it would likely change its current policy that limits the number of allergen units in a blood test from the current limit of 24 to the current limit for skin tests of 65. It is not clear to what extent physicians ordering blood tests would actually increase the number of units per test. However, because the per unit cost of blood tests is considerably higher than the per unit costs for skin tests, any increase in the number of units per test would increase state costs. For comparison, the cost difference between the current maximum number of units for blood tests and the maximum number of units allowed for skin tests (at current utilization rates) would be about $1 million per year.
COMMENTS: According to the author, this bill ensures that Medi-Cal patients with allergies receive the same level of care as private health insurance patients based on nationally recognized professional guidelines. Under existing coverage and payment policies for fee-for-service Med- Cal patients, allergy testing using an IgE blood test is not treated equally with percutaneous skin testing for allergies. If a primary care physician wishes to diagnose allergies, a referral to a specialist for skin testing is allowed. However, if the primary care physician wishes to order a blood test to diagnose allergies without a referral, the physician must document a contraindication to skin testing for the blood test to be ordered. This bill will ensure that primary care doctors are able to diagnose allergies without referral to a specialist and will therefore save Medi-Cal patients the time and effort it takes to find, make an appointment and see one of the limited number of specialists who accept Medi-Cal patients. The author believes this will further save the Medi-Cal system money by reducing the costs associated with referrals to specialists.
Asthma is a chronic inflammatory disease of the airways. Asthma is widespread; in California an estimated 2.5 million adults have asthma along with about 700,000 children. It is one of the most common chronic diseases of childhood. The exact cause of asthma is unknown and it cannot be cured. Asthma can be controlled with self-management education, appropriate medical care, and avoiding exposure to environmental triggers. Allergen exposure is a significant trigger that can worsen symptoms for many patients with asthma.
Food allergies are an immune-based disease that has become a serious health concern in the United States. A recent study estimates that food allergy affects 5% of children under the age of five years and 4% of teens and adults, and its prevalence appears to be on the increase. The symptoms of this disease can range from mild to severe and, in rare cases, can lead to anaphylaxis, a severe and potentially life-threatening allergic reaction. There are no therapies available to prevent or cure food allergies. The only prevention option for the patient is to avoid the food allergen.
How best to determine what those allergens are, and how Medi-Cal coverage policy should approach this issue, was the subject of an August 12, 2014, Assembly Health Committee informational hearing, Medi-Cal: When Reimbursement Policies Interfere with the Standard of Care. Subsequent to the hearing, on May 15, 2015, Medi-Cal removed the requirement that laboratories submit documentation of medical necessity with claims for IgE testing reimbursement. However, limitations on Medi-Cal coverage for IgE which did not apply to skin testing remain.
Anthem Health Insurance and Kaiser Permanente both cover allergy blood tests and skin tests equivalently. According to information requested by the Committee and provided by the sponsor, two of six Medicare claims processing contractors (representing 20 states) treat blood tests and skin test equivalently, the others currently do not. The sponsor states that it has embarked on an educational campaign with the other four contractors.
In a December 2010 report of the National Institute of Allergy and Infectious Diseases (NIAID) sponsored expert panel entitled Guidelines for the Diagnosis and Management of Food Allergy in the U.S., published in the Journal of Allergy and Clinical Immunology, it is stated that both IgE blood tests and skin tests are safe and useful for identifying food allergies. In a February 2010 article in the Journal of Allergy and Clinical Immunology from Johns Hopkins School of Medicine entitled Clinical Laboratory Assessment of Immediate-type Hypersensitivity it is stated that: "For food and respiratory allergy, IgE antibody as detected in the serum by using current autoanalyzer technology and in the skin by using the epicutaneous test are considered equivalent as confirmatory tests in terms of their sensitivity and accuracy." In a supplement to the March 2008 issue of the Annals of Allergy, Asthma, & Immunology entitled Allergy Diagnostic Testing: An Updated Practice Parameter, it is stated that: "There are no clinical scenarios in which immunoassays for allergen specific IgE can be considered either absolutely indicated or contraindicated. There are some situations in which immunoassays may be preferable to skin testing for the diagnostic evaluation of patients."
I am returning Assembly Bill 1739 without my signature.
This bill codifies a specific standard for allergy testing in Medi-Cal.
The Department of Health Care Services already has authority to set allergy testing standards and will be updating them later this year. When it does so, the Department should not be limited, as this bill requires, to considering just the guidelines from National Institutes of Health.
Analysis Prepared by: Paula Villescaz / HEALTH / (916) 319-2097 FN: 0005067
CONCURRENCE IN SENATE AMENDMENTS
CSA1 Bill Id:AB 1739
Author:(Waldron)
As Amended Ver:August 2, 2016
Majority vote
ASSEMBLY: | 79-0 | (May 5, 2016) | SENATE: | 36-0 | (August 18, 2016) |
Original Committee Reference: HEALTH
SUMMARY: Requires the Department of Health Care Services (DHCS), in the evaluation of patients for allergy under fee-for-service Medi-Cal, to treat serologic-specific IgE tests and skin tests as equivalent confirmatory tests.
The Senate amendments require the standard of coverage and medical necessity for allergy tests to be consistent with consensus standards and recommendations in clinical guidelines from the National Institutes of Health, Clinical and Laboratory Standards Institute, and the most current peer-reviewed medical literature pertaining to the utilization of modern serologic-specific IgE tests.
FISCAL EFFECT: According to the Senate Appropriations Committee, likely increased Medi-Cal costs in the hundreds of thousands per year (General Fund and federal funds). The fiscal impact of the bill is subject to some uncertainty. DHCS indicates that under the bill it would likely change its current policy that limits the number of allergen units in a blood test from the current limit of 24 to the current limit for skin tests of 65. It is not clear to what extent physicians ordering blood tests would actually increase the number of units per test. However, because the per unit cost of blood tests is considerably higher than the per unit costs for skin tests, any increase in the number of units per test would increase state costs. For comparison, the cost difference between the current maximum number of units for blood tests and the maximum number of units allowed for skin tests (at current utilization rates) would be about $1 million per year.
COMMENTS: According to the author, this bill ensures that Medi-Cal patients with allergies receive the same level of care as private health insurance patients based on nationally recognized professional guidelines. Under existing coverage and payment policies for fee-for-service Med- Cal patients, allergy testing using an IgE blood test is not treated equally with percutaneous skin testing for allergies. If a primary care physician wishes to diagnose allergies, a referral to a specialist for skin testing is allowed. However, if the primary care physician wishes to order a blood test to diagnose allergies without a referral, the physician must document a contraindication to skin testing for the blood test to be ordered. This bill will ensure that primary care doctors are able to diagnose allergies without referral to a specialist and will therefore save Medi-Cal patients the time and effort it takes to find, make an appointment and see one of the limited number of specialists who accept Medi-Cal patients. The author believes this will further save the Medi-Cal system money by reducing the costs associated with referrals to specialists.
Asthma is a chronic inflammatory disease of the airways. Asthma is widespread; in California an estimated 2.5 million adults have asthma along with about 700,000 children. It is one of the most common chronic diseases of childhood. The exact cause of asthma is unknown and it cannot be cured. Asthma can be controlled with self-management education, appropriate medical care, and avoiding exposure to environmental triggers. Allergen exposure is a significant trigger that can worsen symptoms for many patients with asthma.
Food allergies are an immune-based disease that has become a serious health concern in the United States. A recent study estimates that food allergy affects 5% of children under the age of five years and 4% of teens and adults, and its prevalence appears to be on the increase. The symptoms of this disease can range from mild to severe and, in rare cases, can lead to anaphylaxis, a severe and potentially life-threatening allergic reaction. There are no therapies available to prevent or cure food allergies. The only prevention option for the patient is to avoid the food allergen.
How best to determine what those allergens are, and how Medi-Cal coverage policy should approach this issue, was the subject of an August 12, 2014, Assembly Health Committee informational hearing, Medi-Cal: When Reimbursement Policies Interfere with the Standard of Care. Subsequent to the hearing, on May 15, 2015, Medi-Cal removed the requirement that laboratories submit documentation of medical necessity with claims for IgE testing reimbursement. However, limitations on Medi-Cal coverage for IgE which did not apply to skin testing remain.
The current Medi-Cal Provider Manual states that coverage for allergen specific IgE must include documentation in the patient's medical record with one of the following numbered criteria:
- The patient has persistent asthma and the test is needed to determine the potential sensitivity to perennial indoor allergens to which the patient is exposed, or
- At least one of the following conditions is documented in the patient's medical record:
- Widespread skin disease
- Patients receiving medications that may confound the results of skin testing or interfere with the detection or management of anaphylaxis
- Uncooperative patients
- When the history suggests significant risk of anaphylaxis from skin testing;
- Patients undergoing work-up for major allergic reaction, including possible anaphylaxis or severe urticarial.
The provider manual also states that manual review of the claims is no longer required. Without evidence of medical necessity documented in the patient's medical record, claims billed may be denied.
In correspondence between the former Chair of the Assembly Health Committee and the Director of DHCS the former Chair expressed his concern that Medi-Cal policy, even with the changes of May 15, 2016, unnecessarily inhibits access and timely care for many Medi-Cal patients and is inconsistent with the latest science or with many policies in the commercial markets and other state Medicaid programs.
Anthem Health Insurance and Kaiser Permanente both cover allergy blood tests and skin tests equivalently. According to information requested by the Committee and provided by the sponsor, two of six Medicare claims processing contractors (representing 20 states) treat blood tests and skin test equivalently, the others currently do not. The sponsor states that it has embarked on an educational campaign with the other 4 contractors.
In a December 2010 report of the National Institute of Allergy and Infectious Diseases (NIAID) sponsored expert panel entitled Guidelines for the Diagnosis and Management of Food Allergy in the U.S., published in the Journal of Allergy and Clinical Immunology, it is stated that both IgE blood tests and skin tests are safe and useful for identifying food allergies. In a February 2010 article in the Journal of Allergy and Clinical Immunology from Johns Hopkins School of Medicine entitled Clinical Laboratory Assessment of Immediate-type Hypersensitivity it is stated that: "For food and respiratory allergy, IgE antibody as detected in the serum by using current autoanalyzer technology and in the skin by using the epicutaneous test are considered equivalent as confirmatory tests in terms of their sensitivity and accuracy." In a supplement to the March 2008 issue of the Annals of Allergy, Asthma, & Immunology entitled Allergy Diagnostic Testing: An Updated Practice Parameter, it is stated that: "There are no clinical scenarios in which immunoassays for allergen specific IgE can be considered either absolutely indicated or contraindicated. There are some situations in which immunoassays may be preferable to skin testing for the diagnostic evaluation of patients."
Thermo Fisher Scientific, the sponsor of this bill, argues that Medi-Cal's coverage policy for allergy testing is inconsistent with national guidelines, best practices, and the most recent scientific literature. Food allergy guidelines of the NIAID and the asthma guidelines of the National Heart, Lung, and Blood Institute's recognize that blood tests and skin tests are equivalent in their efficacy for diagnosing allergic sensitizations. Miller Children's Hospital in Long Beach states that updating testing guidelines will have a major positive impact on Medi-Cal patients suffering from allergies. In a perfect world, every patient suffering from an allergic disease would receive their care from a specialist. Unfortunately, allergy specialists are a very scarce resource especially for the Medi-Cal population, with unacceptably long wait times. It is not realistic for DHCS, or any payer, to rely solely on the efforts of specialists to be able to skin test every Medi-Cal patient that requires an allergy test.
Analysis Prepared by: Paula Villescaz / HEALTH / (916) 319-2097 FN: 0004158
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB 1739 |
THIRD READING
Bill No: AB 1739
Amended: 8/2/16 in Senate
SENATE HEALTH COMMITTEE: 8-0, 6/29/16
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen, Pan, Roth
NO VOTE RECORDED: Wolk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/11/16
AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen
ASSEMBLY FLOOR: 79-0, 5/5/16 (Consent) - See last page for vote
SUBJECT: Medi-Cal: allergy testing
SOURCE: Thermo-Fisher Scientifics
DIGEST: This bill requires the Medi-Cal standard of coverage and medical necessity for allergy tests to be consistent with consensus standards and recommendations in clinical guidelines from the National Institutes of Health, Clinical and Laboratory Standards Institute, and the most current peer-reviewed medical literature pertaining to the utilization of modern serologic-specific IgE tests (a type of blood test).
Existing law:
- Establishes the Medi-Cal program, which is administered by the Department of Health Care Services (DHCS), under which qualified low-income individuals receive health care services.
- Establishes a schedule of benefits under the Medi-Cal program, and authorizes the use of utilization controls, including prior authorization, that may be applied to those covered benefits and that are reviewed for, among other things, medical necessity. Physician services are a covered benefit, subject to utilization controls.
- Requires, pursuant to Medi-Cal regulation, outpatient physician services to be covered if they are medically necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain, subject to limitations.
This bill:
- Requires the Medi-Cal standard of coverage and medical necessity for allergy tests to be consistent with consensus standards and recommendations in clinical guidelines from the National Institutes of Health, Clinical and Laboratory Standards Institute, and the most current peer-reviewed medical literature pertaining to the utilization of modern serologic-specific IgE tests.
- Requires DHCS to update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
Comments
- Author’s statement. According to the author, historically, allergies were diagnosed by an allergy specialist who used a “skin-prick” test to infect the skin of a patient and waited to see what the patient reacted to. This requires a patient to be referred to an allergist by their primary care doctor and requires the patient to undergo a series of pricks to their skin. But now blood tests are equally effective in diagnosing allergies and can be ordered directly by a primary care physician without referring the patient to a specialist. Medi-Cal’s provider manual explicitly favors skin testing over blood testing by requiring a primary doctor to identify a “Contraindication” to skin testing before ordering a blood test. This is contrary to National Guidelines. Combined with too few allergy specialists, this creates an access to care problem for Medical patients who need an efficient diagnosis and treatment of allergies. This bill corrects this inequity by requiring DHCS to treat blood allergy tests and skin allergy tests as equivalent in their sensitivity and accuracy for confirming allergies. This bill also requires DHCS to update its provider bulletins to reference the most current professional literature and guidance related to allergy testing.
- Medi-Cal Manual of Criteria. Under existing law, DHCS is authorized to use utilization controls for covered Medi-Cal benefits. The DHCS Manual of Criteria sets for the procedures and codes for providers to use to bill allergy testing and desensitization. It contains the procedure codes and instructions for billing, and the medical reference for the coverage criteria. The Manual of Criteria for allergy testing and desensitization was changed by DHCS in March 2009, June 2012, April 2013, December 2014, and June 2015.
Medi-Cal coverage policy of allergy testing was the subject of an August 12, 2014 Assembly Health Committee informational hearing entitled “Medi-Cal: When Reimbursement Policies Interfere with the Standard of Care.” Subsequent to the hearing, on May 15, 2015, Medi-Cal removed the requirement that laboratories submit documentation of medical necessity with claims for IgE testing reimbursement. However, limitations on Medi-Cal coverage for IgE did not apply to skin testing remain. For example, current coverage for the allergen specific IgE test must include documentation in the patient’s medical record, with one of the following numbered criteria:
- The patient has persistent asthma and the test is needed to determine the potential sensitivity to perennial indoor allergens to which the patient is exposed;
- At least one of the following conditions is documented in the patient’s medical record:
- Widespread skin disease;
- Patients receiving medications that may confound the results of skin testing or interfere with the detection or management of anaphylaxis;
- Uncooperative patients;
- When the history suggests significant risk of anaphylaxis from skin testing; or,
- Patients undergoing work-up for major allergic reaction, including possible anaphylaxis or severe urticarial.
- Medical literature on blood and skin tests for allergies. In a February 2010 article in the Journal of Allergy and Clinical Immunology from Johns Hopkins School of Medicine entitled Clinical Laboratory Assessment of Immediate-type Hypersensitivity it is stated that: “For food and respiratory allergy, IgE antibody as detected in the serum by using current autoanalyzer technology and in the skin by using the epicutaneous test are considered equivalent as confirmatory tests in terms of their sensitivity and accuracy.”
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
According to the Senate Appropriations Committee, likely increased Medi-Cal costs in the hundreds of thousands per year (General Fund and federal funds). The fiscal impact of the bill is subject to some uncertainty. DHCS indicates that under the bill it would likely change its current policy that limits the number of allergen units in a blood test from the current limit of 24 to the current limit for skin tests of 65. It is not clear to what extent physicians ordering blood tests would actually increase the number of units per test. However, because the per unit cost of blood tests is considerably higher than the per unit costs for skin tests, any increase in the number of units per test would increase state costs. For comparison, the cost difference between the current maximum number of units for blood tests and the maximum number of units allowed for skin tests (at current utilization rates) would be about $1 million per year.
Thermo-Fisher Scientific (source)
American Federation of State, County and Municipal Employees, AFL-CIO
California Health+ Advocates
California Life Sciences Association
One individual
Department of Finance
Department of Health Care Services
ARGUMENTS IN SUPPORT: Thermo-Fisher Scientific, the sponsor of this bill, argues that Medi-Cal's coverage policy for allergy testing is inconsistent with national guidelines, best practices, and the most recent scientific literature. Food allergy guidelines of the National Institute of Allergy and Infectious Diseases and the asthma guidelines of the National Heart, Lung, and Blood Institute’s recognize that blood tests and skin tests are equivalent in their efficacy for diagnosing allergic sensitizations.
A physician from Miller Children’s Hospital in Long Beach states that updating testing guidelines will have a major positive impact on Medi-Cal patients suffering from allergies. The physician writes that, in a perfect world, every patient suffering from an allergic disease would receive their care from a specialist. Unfortunately, allergy specialists are a very scarce resource, especially for the Medi-Cal population, with unacceptably long wait times. It is not realistic for DHCS, or any payer, to rely solely on the efforts of specialists to be able to skin test every Medi-Cal patient that requires an allergy test.
The CaliforniaHealth+ Advocates (CH+A) writes in support that this bill will improve patient care, eliminate unnecessary restrictions on primary care physicians’ ability to utilize blood tests as a diagnostic tool for determining sensitivity to allergens in Medi-Cal patients, save money by ensuring timely diagnosis of allergies in Medi-Cal patients, and eliminate unnecessary referrals to an allergist for skin testing. In doing so, CH+A writes this bill eliminate unnecessary barriers to care and create greater equity across our health system.
ARGUMENTS IN OPPOSITION: The Department of Finance (DOF) writes in opposition that this bill could potentially result in increased costs in the low millions of dollars, and General Fund resources to implement these provisions are not included in the 2016 Budget Act. DOF argues this bill limits DHCS’ flexibility to form its Medi-Cal allergy testing policy according to the most appropriate clinical guidelines and consensus standards, and that DHCS already takes into account information available from the National Institutes of Health as required by this bill, but also relies on research from the American Academy of Allergy, Asthma & Immunology, and has the discretion to also consider research from other entities. DOF states DHCS already has the authority to update its provider bulletins and updates them as appropriate, so this bill is unnecessary, and DOF states it is arguable whether access problems to blood tests exist due to current policy, as nearly six times as many Medi-Cal beneficiaries received blood tests versus skin prick tests in 2015. It is unclear if conforming with the specific entities' standards for allergy testing will have any impact on access.
ASSEMBLY FLOOR: 79-0, 5/5/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
NO VOTE RECORDED: Beth Gaines
Prepared by: Scott Bain / HEALTH / (916) 651-4111
8/15/16 20:17:19
**** END ****
SENATE COMMITTEE ON
Senator Ricardo Lara, Chair
2015 - 2016 Regular Session
AB 1739 (Waldron) - Medi-Cal: allergy testing
Version: | Policy Vote: |
Urgency: | Mandate: |
Hearing Date: | Consultant: |
This bill meets the criteria for referral to the Suspense File.
Bill Summary:
AB 1739 would require the Department of Health Care services to use standards of coverage and medical necessity for allergy tests that are consistent with national clinical guidelines.
Fiscal Impact:
Likely increased Medi-Cal costs in the hundreds of thousands per year (General Fund and federal funds). The fiscal impact of the bill is subject to some uncertainty. The Department of Health Care Services indicates that under the bill it would likely change its current policy that limits the number of allergen units in a blood test from the current limit of 24 to the current limit for skin tests of 65. It is not clear to what extent physicians ordering blood tests would actually increase the number of units per test. However, because the per unit cost of blood tests is considerably higher than the per unit costs for skin tests, any increase in the number of units per test would increase state costs. For comparison, the cost difference between the current maximum number of units for blood tests and the maximum number of units allowed for skin tests (at current utilization rates) would be about $1 million per year.
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.
Under current practice in the fee-for-service Medi-Cal system, the Department of Health Care Services places certain limits on the utilization of allergy tests. Department policy limits the number of allergen units that can be included in a blood test to 24, whereas policy limits the number of units that can be included in a skin test to 65. (Utilization controls in the Medi-Cal managed care system are determined by the managed care plans.)
Proposed Law:
AB 1739 would require the Department to use standards for coverage and medical necessity for allergy tests that are consistent with consensus standards and recommendations in clinical guidelines from the National Institutes of Health, Clinical and Laboratory Standards Institute, and the most current peer-reviewed medical literature.
Staff Comments:
Medi-Cal policy does not limit the use of either blood tests or skin prick tests to specialists; primary care physicians can order either test, if medically necessary. However interpretation of those tests is often done by specialists who have more experience interpreting test results. It is not clear whether changes in the bill would substantially change the utilization of specialists to interpret test results.
Currently, there are about 6,000 IgE blood tests ordered for fee-for-service Medi-Cal beneficiaries per year, versus about 1,200 skin prick tests per year.
-- END --
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1739
AUTHOR: | Waldron | ||
VERSION: | June 2, 2016 | ||
HEARING DATE: | June 29, 2016 | ||
CONSULTANT: | Scott Bain | ||
SUBJECT: Medi-Cal: allergy testing
SUMMARY:
Requires the Department of Health Care Services, for individuals with a medical history of specified allergies, to treat serologic-specific IgE tests (a type of blood test) and skin tests as equivalent confirmatory tests in their clinical efficacy, and to provide the same standard of coverage for either test.
Existing law:
- Establishes the Medi-Cal program, which is administered by the Department of Health Care Services (DHCS), under which qualified low-income individuals receive health care services.
- Establishes a schedule of benefits under the Medi-Cal program, and authorizes the use of utilization controls, including prior authorization, that may be applied to those covered benefits and that are reviewed for, among other things, medical necessity. Physician services are a covered benefit, subject to utilization controls.
- Requires, pursuant to Medi-Cal regulation, outpatient physician services to be covered if they are medically necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain, subject to limitations.
This bill:
- Requires DHCS to treat serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in their clinical efficacy, and to provide the same standard of coverage for either test for those individuals with a medical history consistent with any of the following:
- An inhalant allergy;
- A food allergy;
- Hymenoptera venom allergy or an allergy to stinging insects;
- Allergic bronchopulmonary aspergillosis (ABPA);
- Certain parasitic diseases; or,
- Allergies to specific drugs.
- Requires DHCS to update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
FISCAL EFFECT:
According to the Assembly Appropriations Committee, uncertain, likely minor overall fiscal effect in the FFS Medi-Cal program (GF/federal). Blood testing utilization could go up, while utilization of skin tests could go down. The net effect is unknown.
PRIOR VOTES:
Assembly Floor: | 79 - 0 |
Assembly Appropriations Committee: | 19 - 0 |
Assembly Health Committee: | 18 - 0 |
COMMENTS:
- Author’s statement. According to the author, historically, allergies were diagnosed by an allergy specialist who used a “skin-prick” test to infect the skin of a patient and waited to see what the patient reacted to. This requires a patient to be referred to an allergist by their primary care doctor and requires the patient to undergo a series of pricks to their skin. But now blood tests are equally effective in diagnosing allergies and can be ordered directly by a primary care physician without referring the patient to a specialist. Medi-Cal’s provider manual explicitly favors skin testing over blood testing by requiring a primary doctor to identify a “Contraindication” to skin testing before ordering a blood test. This is contrary to National Guidelines. Combined with too few allergy specialists, this creates an access to care problem for Medical patients who need an efficient diagnosis and treatment of allergies. This bill would correct this inequity by requiring DHCS to treat blood allergy tests and skin allergy tests as equivalent in their sensitivity and accuracy for confirming allergies. This bill would also require DHCS to update its provider bulletins to reference the most current professional literature and guidance related to allergy testing.
- Medi-Cal Manual of Criteria. Under existing law, DHCS is authorized to use utilization controls for covered Medi-Cal benefits. The DHCS Manual of Criteria sets for the procedures and codes for providers to use to bill allergy testing and desensitization. It contains the procedure codes and instructions for billing, and the medical reference for the coverage criteria. The Manual of Criteria for allergy testing and desensitization was changed by DHCS in March 2009, June 2012, April 2013, December 2014, and June 2015.
Medi-Cal coverage policy of allergy testing was the subject of an August 12, 2014 Assembly Health Committee informational hearing entitled “Medi-Cal: When Reimbursement Policies Interfere with the Standard of Care.” Subsequent to the hearing, on May 15, 2015, Medi-Cal removed the requirement that laboratories submit documentation of medical necessity with claims for IgE testing reimbursement. However, limitations on Medi-Cal coverage for IgE did not apply to skin testing remain. For example, current coverage for the allergen specific IgE test must include documentation in the patient’s medical record, with one of the following numbered criteria:
- The patient has persistent asthma and the test is needed to determine the potential sensitivity to perennial indoor allergens to which the patient is exposed;
- At least one of the following conditions is documented in the patient’s medical record:
- Widespread skin disease
- Patients receiving medications that may confound the results of skin testing or interfere with the detection or management of anaphylaxis;
- Uncooperative patients;
- When the history suggests significant risk of anaphylaxis from skin testing; or,
- Patients undergoing work-up for major allergic reaction, including possible anaphylaxis or severe urticarial.
- Medical literature on blood and skin tests for allergies. In a February 2010 article in the Journal of Allergy and Clinical Immunology from Johns Hopkins School of Medicine entitled Clinical Laboratory Assessment of Immediate-type Hypersensitivity it is stated that: “For food and respiratory allergy, IgE antibody as detected in the serum by using current autoanalyzer technology and in the skin by using the epicutaneous test are considered equivalent as confirmatory tests in terms of their sensitivity and accuracy
- Support. Thermo Fisher Scientific, the sponsor of this bill, argues that Medi-Cal's coverage policy for allergy testing is inconsistent with national guidelines, best practices, and the most recent scientific literature. Food allergy guidelines of the NIAID and the asthma guidelines of the National Heart, Lung, and Blood Institute’s recognize that blood tests and skin tests are equivalent in their efficacy for diagnosing allergic sensitizations.
A physician from Miller Children’s Hospital in Long Beach states that updating testing guidelines will have a major positive impact on Medi-Cal patients suffering from allergies. The physician writes that, in a perfect world, every patient suffering from an allergic disease would receive their care from a specialist. Unfortunately, allergy specialists are a very scarce resource, especially for the Medi-Cal population, with unacceptably long wait times. It is not realistic for DHCS, or any payer, to rely solely on the efforts of specialists to be able to skin test every Medi-Cal patient that requires an allergy test.
The CaliforniaHealth+ Advocates (CH+A) writes in support that this bill will improve patient care, eliminate unnecessary restrictions on primary care physicians’ ability to utilize blood tests as a diagnostic tool for determining sensitivity to allergens in Medi-Cal patients, save money by ensuring timely diagnosis of allergies in Medi-Cal patients, and eliminate unnecessary referrals to an allergist for skin testing. In doing so, CH+A writes this bill eliminate unnecessary barriers to care and create greater equity across our health system.
- Opposition. DHCS writes in opposition that this bill will change current Medi-Cal policy and contradicts the recommendation of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI). DHCS states Medi-Cal’s allergy testing policy is based upon the AAAAI and ACAAI clinical practice guidelines that recommend the skin prick test as the preferred procedure to test for allergies, and Medi-Cal allows for IgE test when the patient’s medical condition requires another mode of testing other than skin prick. DHCS writes this bill do not reflect current practice guidelines from the leading medical associations for allergy testing, and DHCS writes that AAAAI is working on a new primer/guideline for allergy testing that it expects to publish later this year. DHCS concludes by noting that current Medi-Cal policy for ordering IgE tests does not pose a barrier to access for fee-for-service beneficiaries as DHCS data shows that more beneficiaries are receiving IgE tests than skin prick tests, and when DHCS removed manual review for IgE tests as skin prick tests, nearly six times as many beneficiaries received the IgE test as skin prick tests.
- Policy issues.
- Statutory declaration of equivalent confirmatory tests. This bill, as written, would statutorily require DHCS to declare serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in their clinical efficacy, and would require DHCS to provide the same standard of coverage. The impetus for this bill is current Medi-Cal coverage for the serologic-specific IgE tests is subject to additional criteria that existing skin allergy tests are not. Proponents cite medical literature as to why current Medi-Cal coverage is out-of-date and not consistent with other payors and current medical literature.
However, statutorily declaring two types tests as equivalent in clinical efficacy has the disadvantage of codifying a coverage standard that, even if accurate now, may not be accurate in the future if allergy testing improves. Codifying such a standard in existing law would require subsequent statutory changes if medical evidence and practice guidelines change. In addition, statutorily requiring the same standard of coverage may limit DHCS and Medi-Cal managed care plans’ ability to negotiate lower prices if the tests are of equal efficacy but the cost of a particular test is significantly higher than the other. Finally, the Legislature is generally not well equipped to evaluate the clinical efficacy of competing medical tests and procedures, as compared to peer-reviewed literature published in scientific or medical journals, national expert panels, or consensus practice guidelines.
- Coverage based on medical history. The coverage in this bill is for individuals with a medical history consistent with various allergies, including a food allergy, an allergy to venom or stinging insects, drug allergies or an inhalant allergy. However, allergy testing is typically used to strengthen a diagnosis of patients who present with allergy symptoms following a clinical history and physical examination. These individuals may or may not have a medical history consistent with allergies. In lieu of coverage based on medical history, the coverage in this bill could be based on “symptoms compatible with an allergic disorder” or words to that effect.
To address the issues in a) and b), alternative language to the language in this bill is as follows:
14133.75(a) The department shall treat serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in their clinical efficacy, and shall provide the same standard of coverage for either test for those individuals with a medical history consistent with any of the following: The department shall provide the same standard of coverage for serologic-specific IgE tests and percutaneous skin tests if peer-reviewed medical literature supports a determination that those tests are equivalent confirmatory tests in terms of their clinical efficacy. If that determination is made the department shall provide coverage for either test for a beneficiary who has symptoms consistent with any of the following:
(1) An inhalant allergy.
(2) A food allergy.
(3) Hymenoptera venom allergy or an allergy to stinging insects.
(4) Allergic bronchopulmonary aspergillosis (ABPA).
(5) Certain parasitic diseases.
(6) Allergies to specific drugs.
(7) The department shall update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing
SUPPORT AND OPPOSITION:
Support: Thermo-Fisher Scientific (sponsor)
American Federation of State, County and Municipal Employees, AFL-CIO
California Life Sciences Association
One individual
Oppose: Department of Health Care Services
-- END --
Date of Hearing: April 27, 2016
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez, Chair
ABPCA Bill Id:AB 1739
Author:(Waldron) – As Amended Ver:April 19, 2016
Policy Committee: | Health | Vote: | 18 - 0 |
|
|
Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill requires the Department of Health Care Services (DHCS), in the evaluation of patients for allergy under fee-for-service (FFS) Medi-Cal, to treat serologic-specific immunoglobulin E (IgE) tests (blood tests) and skin tests as equivalent confirmatory tests.
FISCAL EFFECT:
Uncertain, likely minor overall fiscal effect in the FFS Medi-Cal program (GF/federal). Blood testing utilization could go up, while utilization of skin tests could go down. The net effect is unknown.
COMMENTS:
- Purpose. This bill is intended to ensure that Medi-Cal patients with allergies receive timely diagnoses. Under current practice, if a primary care physician wishes to diagnose allergies, a referral to a specialist for skin testing is allowed. However, if the primary care physician wishes to order a blood test to diagnose allergies without a referral, the physician can only do so under certain circumstances. The author notes this bill will facilitate reimbursement for blood tests offered by primary care providers, which the author indicates will increase access to allergy diagnostic testing.
- Background. Allergy and asthma are prevalent in the general population. In California, an estimated 2.5 million adults have asthma along with about 700,000 children. With respect to food allergies, a recent study estimates that food allergy affects 5% of children under the age of five years and 4% of teens and adults, and its prevalence appears to be on the increase.
DHCS and other payers often translate guidelines into medical coverage specifications. Medi-Cal coverage for allergy testing aligns with 2008 guidelines issued by the American Academy of Allergy, Asthma & Immunology (AAAAI). Guidelines by other organizations, such as the National Institutes of Health, also address the effectiveness of allergy diagnostic tests. The AAAAI guidelines upon which Medi-Cal's coverage policy are based are being updated this year.
Proponents of this bill note the 2008 guidelines are out of date, and also note practical considerations that Medi-Cal patients face obtaining allergy skin testing, which requires an appointment with an allergist. Unlike skin tests, blood tests can be administered in a primary care setting.
This issue was the subject of an August 12, 2014 Assembly Health Committee informational hearing, which focused broadly on the potential for utilization controls to interfere with providing access to the standard of care, as well as specifically on reimbursement for allergy diagnostic testing. Subsequent to the hearing, on May 15, 2015, Medi-Cal removed the requirement that laboratories submit documentation of medical necessity with claims for blood test reimbursement. However, other limitations on Medi-Cal coverage for blood tests remain.
It should be noted, however, that diagnostic tests are not a slam dunk for diagnosing allergies. A 2012 article in the journal Pediatrics providing guidelines to pediatricians discusses the complexity of allergy diagnosis, and notes a detection of sensitization to an allergen through a blood test is not equivalent to a clinical diagnosis. Many children with positive tests have no clinical illness when exposed to the allergen. They indicate this limitation highlights the need for the clinician to use a detailed medical history and have knowledge of the features of the specific illness when selecting and interpreting tests. In essence, these tests require a level of training in how to interpret them in light of other relevant patient-level considerations outside of the blood test results. Because test limitations often warrant additional evaluation to confirm the role of specific allergens, the article advises a consultation with a board-certified allergist-immunologist should be considered.
- Staff Comments. Evidence-based coverage guidelines generally ensure care is provided in a manner supported by science and medical consensus. These guidelines are constantly evolving as new research is published and reviewed. This bill, as written, would statutorily dictate specific coverage parameters for certain tests, which is not common practice, and has the disadvantage of being static and less flexible to changing guidelines as well as lacking review by medical professionals. Staff also notes the clinical guidelines upon which Medi-Cal coverage is based are already in the process of being updated, raising questions of whether this bill is premature. On the other hand, if difficulty and hassle accessing allergists and receiving skin tests delay or prevent diagnosis of allergy where it would be helpful, there seems to be merit to considering the real-world impact of coverage guideline on access to timely and appropriate care in a real-world setting.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
Date of Hearing: April 12, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
ABPCA Bill Id:AB 1739
Author:(Waldron) – As Amended Ver:March 16, 2016
SUBJECT: Medi-Cal: allergy testing.
SUMMARY: Requires the Department of Health Care Services (DHCS), in the evaluation of patients for allergy under fee-for-service Medi-Cal, to treat serologic-specific IgE tests and skin tests as equivalent confirmatory tests. Specifically, this bill:
- Requires DHCS to treat serologic-specific IgE tests and percutaneous skin tests equivalent tests in terms of their sensitivity and accuracy, and to treat them as medically necessary for those individuals with a medical history consistent with any of the following:
- An inhalant allergy;
- A food allergy;
- Hymenoptera venom allergy or an allergy to stinging insects;
- Allergic bronchopulmonary aspergillosis;
- Certain parasitic diseases; and,
- Allergies to specific drugs.
- Requires DHCS to update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing.
EXISTING LAW:
- Establishes the Medi-Cal program, administered by DHCS, under which qualified low-income patients receive health care benefits. Medi-Cal is California’s version of the federal Medical program in which funding is provided by both the state and federal government.
- Provides for a schedule of benefits under the Medi-Cal program, and authorizes the use of utilization control, including prior authorization, that may be applied to those covered benefits and that are reviewed for, among, other things, medical necessity.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.
COMMENTS:
- PURPOSE OF THIS BILL. According to the author, this bill ensures that Medi-Cal patients with allergies receive the same level of care as private health insurance patients based on nationally recognized professional guidelines. Under existing coverage and payment policies for fee-for-service Med- Cal patients, allergy testing using an IgE blood test is not treated equally with percutaneous skin testing for allergies. If a primary care physician wishes to diagnose allergies, a referral to a specialist for skin testing is allowed. However, if the primary care physician wishes to order a blood test to diagnose allergies without a referral, the physician must document a contraindication to skin testing for the blood test to be ordered. This bill will ensure that primary care doctors are able to diagnose allergies without referral to a specialist and will therefore save Medi-Cal patients the time and effort it takes to find, make an appointment and see one of the limited number of specialists who accept Medi-Cal patients. The author believes this will further save the Medi-Cal system money by reducing the costs associated with referrals to specialists.
- BACKGROUND. Asthma is a chronic inflammatory disease of the airways. Asthma is widespread; in California an estimated 2.5 million adults have asthma along with about 700,000 children. It is one of the most common chronic diseases of childhood. The exact cause of asthma is unknown and it cannot be cured. Asthma can be controlled with self-management education, appropriate medical care, and avoiding exposure to environmental triggers. Allergen exposure is a significant trigger that can worsen symptoms for many patients with asthma.
Food allergies are an immune-based disease that has become a serious health concern in the United States. A recent study estimates that food allergy affects 5% of children under the age of five years and 4% of teens and adults, and its prevalence appears to be on the increase. The symptoms of this disease can range from mild to severe and, in rare cases, can lead to anaphylaxis, a severe and potentially life-threatening allergic reaction. There are no therapies available to prevent or cure food allergies. The only prevention option for the patient is to avoid the food allergen.
How best to determine what those allergens are, and how Medi-Cal coverage policy should approach this issue, was the subject of an August 12, 2014 Assembly Health Committee informational hearing, Medi-Cal: When Reimbursement Policies Interfere with the Standard of Care. Subsequent to the hearing, on May 15, 2015, Medi-Cal removed the requirement that laboratories submit documentation of medical necessity with claims for IgE testing reimbursement. However, limitations on Medi-Cal coverage for IgE which did not apply to skin testing remain.
- MEDI-CAL PROVIDER MANUAL. The current Medi-Cal Provider Manual states that coverage for allergen specific IgE must include documentation in the patient’s medical record with one of the following numbered criteria:
“1. The patient has persistent asthma and the test is needed to determine the potential sensitivity to perennial indoor allergens to which the patient is exposed, or
2. At least one of the following conditions is documented in the patient’s medical record:
• Widespread skin disease
• Patients receiving medications that may confound the results of skin testing or interfere with the detection or management of anaphylaxis
• Uncooperative patients
• When the history suggests significant risk of anaphylaxis from skin testing
• Patients undergoing work-up for major allergic reaction, including possible anaphylaxis or severe urticarial.”
The provider manual also states that manual review of the claims is no longer required. Without evidence of medical necessity documented in the patient’s medical record, claims billed may be denied.
In correspondence between the former Chair of the Assembly Health Committee and the Director of DHCS the former Chair expressed his concern that Medi-Cal policy, even with the changes of May 15, 2016, unnecessarily inhibits access and timely care for many Medi-Cal patients and is inconsistent with the latest science or with many policies in the commercial markets and other state Medicaid programs.
- IgE COVERAGE POLICY BY OTHER INSURERS. Anthem Health Insurance and Kaiser Permanente both cover allergy blood tests and skin tests equivalently. According to information requested by the Committee and provided by the sponsor, two of six Medicare claims processing contractors (representing 20 states) treat blood tests and skin test equivalently, the others currently do not. The sponsor states that it has embarked on an educational campaign with the other 4 contractors.
- MEDICAL LITERATURE. In a December 2010 report of the National Institute of Allergy and Infectious Diseases (NIAID) sponsored expert panel entitled Guidelines for the Diagnosis and Management of Food Allergy in the U.S., published in the Journal of Allergy and Clinical Immunology, it is stated that both IgE blood tests and skin tests are safe and useful for identifying food allergies. In a February 2010 article in the Journal of Allergy and Clinical Immunology from Johns Hopkins School of Medicine entitled Clinical Laboratory Assessment of Immediate-type Hypersensitivity it is stated that: “For food and respiratory allergy, IgE antibody as detected in the serum by using current autoanalyzer technology and in the skin by using the epicutaneous test are considered equivalent as confirmatory tests in terms of their sensitivity and accuracy. " In a supplement to the March 2008 issue of the Annals of Allergy, Asthma, & Immunology entitled Allergy Diagnostic Testing: An Updated Practice Parameter, it is stated that: “There are no clinical scenarios in which immunoassays for allergen specific IgE can be considered either absolutely indicated or contraindicated. There are some situations in which immunoassays may be preferable to skin testing for the diagnostic evaluation of patients.”
- SUPPORT. Thermo Fisher Scientific, the sponsor of this bill, argues that Medi-Cal's coverage policy for allergy testing is inconsistent with national guidelines, best practices, and the most recent scientific literature. Food allergy guidelines of the NIAID and the asthma guidelines of the National Heart, Lung, and Blood Institute’s recognize that blood tests and skin tests are equivalent in their efficacy for diagnosing allergic sensitizations. Miller Children’s Hospital in Long Beach states that updating testing guidelines will have a major positive impact on Medi-Cal patients suffering from allergies. In a perfect world, every patient suffering from an allergic disease would receive their care from a specialist. Unfortunately, allergy specialists are a very scarce resource especially for the Medi-Cal population, with unacceptably long wait times. It is not realistic for DHCS, or any payer, to rely solely on the efforts of specialists to be able to skin test every Medi-Cal patient that requires an allergy test.
- TECHNICAL AMENDMENT. The Committee may suggest the following amendment: On page 3, line 17-18, delete “treat them as medically necessary” and replace with “provide the same standard of coverage for either test.”
REGISTERED SUPPORT / OPPOSITION:
Support
Thermo Fisher Scientific (sponsor)
Miller Children’s Hospital
Opposition
None on file.
Analysis Prepared by: John Gilman / HEALTH / (916) 319-2097
Discussed in Hearing
Assembly Floor
Senate Floor
Senate Standing Committee on Health
Assembly Standing Committee on Health
Bill Author
Bill Co-Author(s):