Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and 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. Covered benefits under the Medi-Cal program include the purchase of prescribed drugs, subject to the Medi-Cal List of Contract Drugs and utilization controls.

This bill, which would be known as the Patient Access to Prescribed Epilepsy Treatments Act, would subject, to the extent permitted by federal law, the denial of coverage by a Medi-Cal managed care plan of any drug in the seizure or epilepsy therapeutic drug class prescribed by a Medi-Cal beneficiarys treating provider to an urgent appeal process, as specified, if the treating provider demonstrates that in his or her reasonable, professional judgment, the drug is medically necessary and consistent with specified federal rules and regulations, and the drug is not on the Medi-Cal managed care plan formulary.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and 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. Covered benefits under the Medi-Cal program include the purchase of prescribed drugs, subject to the Medi-Cal List of Contract Drugs and utilization controls.

This bill, which would be known as the Patient Access to Prescribed Epilepsy Treatments Act, would subject, to the extent permitted by federal law, the denial of coverage by a Medi-Cal managed care plan of any drug in the seizure or epilepsy therapeutic drug class prescribed by a Medi-Cal beneficiarys treating provider to an automatic urgent appeal process, as specified, if the treating provider demonstrates that in his or her reasonable, professional judgment, the drug is medically necessary and consistent with specified federal rules and regulations, and the drug is not on the Medi-Cal managed care plan formulary.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and 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. Covered benefits under the Medi-Cal program include the purchase of prescribed drugs, subject to the Medi-Cal List of Contract Drugs and utilization controls.

This bill, which would be known as the Patient Access to Prescribed Epilepsy Treatments Act, would require, subject, to the extent permitted by federal law, that any drug in the seizure or epilepsy therapeutic drug class would be a covered benefit under the Medi-Cal program. The bill would require a Medi-Cal managed care plan to provide coverage for these drugs, regardless of whether the drug is on the plans formulary, the denial of coverage by a Medi-Cal managed care plan of any drug in the seizure or epilepsy therapeutic drug class prescribed by a Medi-Cal beneficiarys treating provider to an automatic urgent appeal process, as specified, if the treating provider demonstrates that in his or her reasonable, professional judgment, the drug is medically necessary, necessary and consistent with specified federal rules and regulations, and the drug is not on the Medi-Cal managed care plan formulary, and consistent with specified federal rules and regulations, under which circumstances the beneficiary would be entitled to an automatic urgent appeal, as defined. formulary.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and 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. Covered benefits under the Medi-Cal program include the purchase of prescribed drugs, subject to the Medi-Cal List of Contract Drugs and utilization controls.

This bill, which would be known as the Patient Access to Prescribed Epilepsy Treatments Act, would require, to the extent permitted by federal law, that any drug in the seizure or epilepsy therapeutic drug class would be a covered benefit under the Medi-Cal program. The bill would require a Medi-Cal managed care plan to provide coverage for these drugs, regardless of whether the drug is on the plans formulary, if the treating provider demonstrates that, that in his or her reasonable, professional judgment, the drug is medically necessary, not on the Medi-Cal managed care plan formulary, and consistent with specified federal rules and regulations. If the managed care plan elects not to cover a drug described in the bill, the drug would be deemed a noncapitated benefit not reimbursed by the managed care plan, which would be available on a fee-for-service basis, and the plans contracted rate would be reduced to reflect the cost to the state of providing the benefit to the patient, as specified. This bill would declare the intent of the Legislature that a prescribers reasonable, professional judgment prevail in prescribing the drugs described in the bill to Medi-Cal patients. regulations, under which circumstances the beneficiary would be entitled to an automatic urgent appeal, as defined.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and 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. Covered benefits under the Medi-Cal program include the purchase of prescribed drugs, subject to the Medi-Cal List of Contract Drugs and utilization controls. Existing law provides that it is the intent of the Legislature to provide, to the extent practicable, for health care for those aged and other persons who lack sufficient annual income to meet the costs of health care, and whose other assets are so limited that their application toward the costs of care would jeopardize the persons or familys future minimum self-maintenance and security.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and 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 that it is the intent of the Legislature to provide, to the extent practicable, for health care for those aged and other persons who lack sufficient annual income to meet the costs of health care, and whose other assets are so limited that their application toward the costs of care would jeopardize the persons or familys future minimum self-maintenance and security.

This bill would make technical, nonsubstantive changes to those provisions.

GOVERNOR'S VETO

GV Bill Id:AB 68

Author:(Waldron)

As Enrolled Ver:September 8, 2015

2/3 vote

Original Committee Reference: HEALTH

SUMMARY: Establishes that a beneficiary has a right to an urgent appeal process of a Medi-Cal managed care plan's denial of a drug used in the treatment of seizures and epilepsy and is a drug approved by the federal Food and Drug Administration for the treatment of seizures and epilepsy.

The Senate amendments clarify that an urgent appeal process must be requested orally or in writing by a beneficiary or treatment provider with the consent of the beneficiary.

EXISTING LAW:

1. Requires states, under the federal Medicaid law, to have a drug use review program for covered outpatient prescription drugs, to ensure drugs are appropriate, medically necessary, and not likely to result in adverse medical effects. Federal law requires the program to assess data on drug use against predetermined standards, consistent with specified factors, including compendia.

2. Provides a schedule of benefits provided in the Medi-Cal program, including prescription drug benefits.

3. Authorizes the Department of Health Care Services (DHCS) to establish utilization controls for any Medi-Cal services as long as the controls are reasonably related to the purpose of establishing them. Allows the utilization controls include prior authorization, pre- and post-service audits, limitations on the number of services and review pursuant to professional standards.

FISCAL EFFECT: According to the Senate Appropriations Committee, likely one-time costs of up to $150,000 to make administrative changes by DHCS, likely minor costs to monitor Medi-Cal managed care plan compliance with the bill's requirements by DHCS, and an unknown impact on the cost to provide prescription drugs by Medi-Cal managed care plans.

COMMENTS: The author argues this bill is a reasonable plan to stabilize those with life-threatening conditions by ensuring a timely appeal if there is a denial by a managed care plan. The author notes those who can afford private insurance plans have doctors who may have more time to work through the existing pre-authorization processes to attain a higher tier drug for their patients, however, those in vulnerable low-income situations are seeing their doctors most likely in clinics, where doctors are short on time and do not have the resources to follow-up on preauthorization appeals. The author concludes this bill levels the playing field for access to medically necessary drugs for low income patients with serious, chronic or life threatening conditions by granting them the right to an urgent appeal.

Medi-Cal is one of the largest drug purchasers in the state. The program spends about $4 billion on prescription drugs, including indirect expenditures through payment to managed care plans and direct expenditures in fee for service and for prescription drugs that are "carved out" of managed care. Carved out means that the state pays directly for the drug rather than indirectly through a capitated or fixed rate payment to a Medi-Cal managed care plan.

Facing significantly rising costs, the federal and state governments have grappled with various cost control measures. California, to help manage costs, has established a formulary for the fee-for service program. The formulary is not binding on Medi-Cal managed care plans, each of which creates their own formulary. A variety of utilization tools also are used. These include limiting prescriptions to six per month, although many beneficiaries receive more but only after a prior authorization has been approved. Frequent and high cost prescription drug users can be identified and case management interventions can be used if appropriate to reduce drug costs.

Epilepsy is a chronic disorder, the hallmark of which is recurrent, unprovoked seizures. Many people with epilepsy have more than one type of seizure and may have other symptoms of neurological problems as well. Although the symptoms of a seizure may affect any part of the body, the electrical events that produce the symptoms occur in the brain. The location of that event, how it spreads and how much of the brain is affected, and how long it lasts all have profound effects. These factors determine the character of a seizure and its impact on the individual. Having seizures and epilepsy can affect one's safety, relationships, work, driving and so much more. How epilepsy is perceived or how people are treated can become a bigger problem than the seizures.

Anti-epileptic drugs (AEDs) are the main form of treatment for people with epilepsy. And up to 70% people with epilepsy could have their seizures completely controlled with AEDs. There are around 25 AEDs used to treat seizures, and different AEDs work for different seizures.

Supporters note, on a prior version of the bill, that epilepsy is a serious medical condition that produces seizures and one seizure can have significant consequences, including head injury limitations in driving or employment, hospitalization and sudden unexpected death. They argue that failure to effectively manage epilepsy and prevent breakthrough seizures results in higher costs to the Medi-Cal program and society through increased hospitalizations, relapses and deteriorating conditions which necessitate additional and expensive care.

There is no known opposition to this bill.

GOVERNOR'S VETO MESSAGE:

This bill would grant a Medi-Cal beneficiary the right to an urgent appeal when a Medi-Cal managed care plan denies coverage for a drug prescribed for the treatment of epilepsy.

The health plans are already required to have effective up-to-date drug formularies and expedited appeal processes to cover situations when health care services, including epilepsy drugs, are denied. I believe establishing a separate urgent appeal for this specific medical condition is unnecessary.

Analysis Prepared by: Patty Rodgers / HEALTH / (916) 319-2097 FN: 0002489

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 68

Author:(Waldron)

As Amended Ver:August 18, 2015

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Establishes that a beneficiary has a right to an urgent appeal process of a Medi-Cal managed care plan's denial of a drug used in the treatment of seizures and epilepsy and is a drug approved by the federal Food and Drug Administration for the treatment of seizures and epilepsy.

The Senate amendments clarify that an urgent appeal process must be requested orally or in writing by a beneficiary or treatment provider with the consent of the beneficiary.

EXISTING LAW:

1. Requires states, under the federal Medicaid law, to have a drug use review program for covered outpatient prescription drugs, to ensure drugs are appropriate, medically necessary, and not likely to result in adverse medical effects. Federal law requires the program to assess data on drug use against predetermined standards, consistent with specified factors, including compendia.

2. Provides a schedule of benefits provided in the Medi-Cal program, including prescription drug benefits.

3. Authorizes the Department of Health Care Services (DHCS) to establish utilization controls for any Medi-Cal services as long as the controls are reasonably related to the purpose of establishing them. Allows the utilization controls include prior authorization, pre- and post-service audits, limitations on the number of services and review pursuant to professional standards.

FISCAL EFFECT: According to the Senate Appropriations Committee, likely one-time costs of up to $150,000 to make administrative changes by DHCS, likely minor costs to monitor Medi-Cal managed care plan compliance with the bill's requirements by DHCS, and an unknown impact on the cost to provide prescription drugs by Medi-Cal managed care plans.

COMMENTS: The author argues this bill is a reasonable plan to stabilize those with life-threatening conditions by ensuring a timely appeal if there is a denial by a managed care plan. The author notes those who can afford private insurance plans have doctors who may have more time to work through the existing pre-authorization processes to attain a higher tier drug for their patients, however, those in vulnerable low-income situations are seeing their doctors most likely in clinics, where doctors are short on time and do not have the resources to follow-up on preauthorization appeals. The author concludes this bill levels the playing field for access to medically necessary drugs for low income patients with serious, chronic or life threatening conditions by granting them the right to an urgent appeal.

Medi-Cal is one of the largest drug purchasers in the state. The program spends about $4 billion on prescription drugs, including indirect expenditures through payment to managed care plans and direct expenditures in fee for service and for prescription drugs that are "carved out" of managed care. Carved out means that the state pays directly for the drug rather than indirectly through a capitated or fixed rate payment to a Medi-Cal managed care plan.

Facing significantly rising costs, the federal and state governments have grappled with various cost control measures. California, to help manage costs, has established a formulary for the fee-for service program. The formulary is not binding on Medi-Cal managed care plans, each of which creates their own formulary. A variety of utilization tools also are used. These include limiting prescriptions to six per month, although many beneficiaries receive more but only after a prior authorization has been approved. Frequent and high cost prescription drug users can be identified and case management interventions can be used if appropriate to reduce drug costs.

Epilepsy is a chronic disorder, the hallmark of which is recurrent, unprovoked seizures. Many people with epilepsy have more than one type of seizure and may have other symptoms of neurological problems as well. Although the symptoms of a seizure may affect any part of the body, the electrical events that produce the symptoms occur in the brain. The location of that event, how it spreads and how much of the brain is affected, and how long it lasts all have profound effects. These factors determine the character of a seizure and its impact on the individual. Having seizures and epilepsy can affect one's safety, relationships, work, driving and so much more. How epilepsy is perceived or how people are treated can become a bigger problem than the seizures.

Anti-epileptic drugs (AEDs) are the main form of treatment for people with epilepsy. And up to 70% people with epilepsy could have their seizures completely controlled with AEDs. There are around 25 AEDs used to treat seizures, and different AEDs work for different seizures.

Supporters note, on a prior version of the bill, that epilepsy is a serious medical condition that produces seizures and one seizure can have significant consequences, including head injury limitations in driving or employment, hospitalization and sudden unexpected death. They argue that failure to effectively manage epilepsy and prevent breakthrough seizures results in higher costs to the Medi-Cal program and society through increased hospitalizations, relapses and deteriorating conditions which necessitate additional and expensive care.

There is no known opposition to this bill.

Analysis Prepared by: Roger Dunstan / HEALTH / (916) 319-2097 FN: 0001881

 THIRD READING  

Bill No: AB 68

Author: Waldron (R)

Amended: 8/18/15 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 9-0, 7/15/15

AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen, Pan, Roth, Wolk

SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/27/15

AYES: Lara, Bates, Beall, Hill, Leyva, Mendoza, Nielsen

ASSEMBLY FLOOR: 78-0, 6/3/15 - See last page for vote

SUBJECT: Medi-Cal

SOURCE: Author

DIGEST: This bill requires a Medi-Cal beneficiary to be entitled to an automatic urgent appeal, as defined, when a Medi-Cal managed care plan denies coverage for a drug prescribed for the treatment of seizures and epilepsy that is approved by the Food and Drug Administration (FDA) for the use in the treatment of seizures and epilepsy if the patient’s treating provider demonstrates that in his or her reasonable, professional judgment, the drug is medically necessary and consistent with FDA labeling and use rules and regulations, as supported in at least one of the official compendia, and the drug is not on the formulary of the Medi-Cal managed care plan.

ANALYSIS:

Existing law:

1. Establishes the Medi-Cal program, administered by the Department of Health Care Services (DHCS), under which basic health care services are provided to qualified low-income persons.
   
   

2. Requires the mandatory enrollment of specified Medi-Cal beneficiaries into Medi-Cal managed care plans.

3. Requires a Medi-Cal managed care plan that has prescription drugs as one of its benefits and that enters into a contract with DHCS to ensure the timely and efficient processing of authorization requests for drugs, when prescribed for plan enrollees, that are covered under the terms of the plan’s contract with DHCS and which require prior authorization from the plan, by providing both of the following:

1. A response within 24 hours or one business day to a request for prior authorization made by telephone or other telecommunication device.

2. The dispensing of at least a 72-hour supply of a covered outpatient drug in an emergency situation.

2. Requires, pursuant to regulation, Medi-Cal applicants or beneficiaries to have the right to a state hearing (known as a “fair hearing”) if dissatisfied with any action or inaction of the county department, DHCS or any person or organization acting in behalf of the county or DHCS relating to Medi-Cal eligibility or benefits.
   
   

3. Requires health plans licensed under the Knox-Keene Act (Medi-Cal plans, with the exception of county organized health systems and PACE (Program of All-inclusive Care for the Elderly) plans are required to be Knox-Keene licensed) to do all of the following:
   
   

   1. Establish and maintain a grievance system approved by the Department of Managed Health Care, under which enrollees may submit their grievances to the plan. Requires an expedited plan review of grievances for cases involving an imminent and serious threat to the health of the patient, including, but not limited to, severe pain, potential loss of life, limb, or major bodily function;

2. Maintain an expeditious sprocess by which prescribing providers may obtain authorization for a medically necessary non-formulary prescription drug; and,

3. Provide an enrollee with the opportunity to seek an independent medical review whenever health care services have been denied, modified, or delayed by the plan, or by one of its contracting providers, if the decision was based in whole or in part on a finding that the proposed health care services are not medically necessary.

This bill:

1. Requires, to the extent permitted by federal law, if any drug used in the treatment of seizures and epilepsy is prescribed by a Medi-Cal beneficiary’s treating provider for the treatment of seizures and epilepsy, and coverage for that prescribed drug is denied by a Medi-Cal managed care plan in which the beneficiary is enrolled, that denial to be reviewed in accordance with the requirements of this bill.

2. Makes the denial by a Medi-Cal managed care plan of a drug prescribed for the treatment of seizures and epilepsy and approved by the FDA for the use in the treatment of seizures and epilepsy subject to an urgent appeal process established by this bill, if:

1. The treating provider demonstrates, consistent with federal law, that in his or her reasonable, professional judgment, the drug is medically necessary and consistent with the FDA’s labeling and use rules and regulations, as supported in at least one of the official compendia identified in federal Medicaid law; and,

2. The drug is not on the formulary for the Medi-Cal managed care plan.

3. Requires a Medi-Cal beneficiary to be entitled to an urgent appeal in a case in which a plan denies coverage for a drug prescribed for the treatment of seizures and epilepsy and approved by the federal FDA for the use in the treatment of seizures and epilepsy. Requires an urgent appeal to be resolved by the plan within 24 hours after the plan receives the request. Requires the 24-hour period to be in addition to any time prescribed by federal law.

4. Defines an “urgent appeal” as an appeal in which the beneficiary, or treatment provider with the consent of the beneficiary, requests an urgent appeal either orally or in writing.
   
   

5. States legislative intent that a Medi-Cal beneficiary have prompt access to medically necessary drugs for use in the treatment of seizures and epilepsy that have been approved by the FDA for use in the treatment of seizures or epilepsy, including drugs that are not on the formulary of a Medi-Cal managed care plan or that are subject to prior authorization.

Comments

1. Author’s statement. According to the author, epilepsy is life-threatening and the first treatment is typically the best chance to get the disease under control. Formularies and step-therapy programs are not always sufficient to treat certain vulnerable populations. New pharmaceuticals and treatments are emerging rapidly, while insurance formularies do not have the capacity to keep up. In the meantime, patient care is being affected and individuals are losing access to receive the best pharmaceuticals that may control their condition sooner rather than later. Current formulary restrictions have multiple appeals processes patients have to go through. Step therapy correspondingly delays the patient from obtaining the most suitable drug combinations for their case.
   
   

2. Background on epilepsy. According to the Centers for Disease Control and Prevention, epilepsy is a disorder of the brain that causes seizures. These seizures are not caused by a temporary underlying medical condition such as a high fever. Epilepsy can affect people in very different ways as there are many causes and many different kinds of seizures. Some people may have multiple types of seizures or other medical conditions in addition to epilepsy. These factors play a major role in determining both the severity of the person’s condition and the impact it has on his or her life. The way a seizure looks depends on the type of seizure a person is experiencing. Some seizures can look like staring spells. Other seizures can cause a person to collapse, shake, and become unaware of what is going on around them. Epilepsy can be caused by different conditions that affect a person's brain. For two in three people, the cause of epilepsy is unknown. Some causes include stroke, brain tumor, traumatic brain injury or head injury or central nervous infection. A person with epilepsy is not contagious and cannot give epilepsy to another person. According to the latest estimates, about 1.8% of adults aged 18 years or older have had a diagnosis of epilepsy or seizure disorder.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee:

1. Likely one-time costs of up to $150,000 to make administrative changes by DHCS (General Fund and federal funds). DHCS indicates that it would need to update existing regulations, managed care plan contracts, Notice of Action forms, and appeals reporting templates.

2. Likely minor costs to monitor Medi-Cal managed care plan compliance with this bill’s requirements by DHCS.

3. Unknown impact on the cost to provide prescription drugs by Medi-Cal managed care plans (General Fund and federal funds). Managed care plans create drug formularies as a way to control costs, by selecting low cost drugs and by increasing their bargaining power with drug companies. By creating a new appeals process to provide increased access to drugs that are not on Medi-Cal manage care plans’ drug formularies, this bill may increase patient access to more expensive drugs and/or reduce the managed care plans’ ability to negotiate discounts and rebates with drug manufacturers. The extent to which this will increase spending on prescription drugs is unknown.

SUPPORT: (Verified 8/28/15)

American Federation of State, County and Municipal Employees, AFL-CIO

Association of Regional Center Agencies

Biocom

California Chronic Care Coalition

California Healthcare Institute

California Life Sciences Association

Child Neurology Foundation

Disability Rights California

Epilepsy California

Sunovion Pharmaceuticals

OPPOSITION: (Verified 8/28/15)

California Association of Health Plans

ARGUMENTS IN SUPPORT: Epilepsy California writes in support that for the majority of people living with epilepsy, anti-epilepsy medications (anticonvulsants) are the most common and most cost effective treatment for controlling and/or reducing seizures. But there is no “one-size fits all” treatment option for epilepsy, and the response to epilepsy medications can be different for each person. Physicians must be able to use their reasonable, professional judgment to prescribe FDA-approved medications that are best for each patient, and patients must gain timely access to these medications without enduring a lengthy appeal process. Epilepsy California writes that timely access to the most appropriate medications to control their seizures will go a long way to reduce Medi-Cal patients’ admissions for emergency room intervention.

Sunovion Pharmaceuticals writes in support that this bill will help ensure patient access to medically necessary treatment and care for seizures and epilepsy and establishes a clear policy that will translate across all managed care plans and help ensure that Medi-Cal patients have equal access to drugs best suited to treat this serious condition. Sunovion writes that without access to medically necessary medications, patients are subjected to uncoordinated and inappropriate treatment patterns often leading to non-adherence and ultimately hospitalization. Sunovion states that numerous studies have found that limiting access to treatment options for epilepsy does not reduce overall health care costs. Studies have shown that the primary driver of direct costs associated with epilepsy treatment are attributed to medical costs rather than anti-epileptic drug costs. Sunovion writes that maintaining seizure control requires careful evaluation and monitoring by the physician and patient, and physicians treating epilepsy must be able to prescribe drugs that are best for each patient, based on independent clinical judgment, and this bill establishes a policy where a prescriber's reasonable professional judgment has the opportunity to prevail when prescribing a product for such a serious condition. This bill will help ensure patients in the Medi-Cal program will be able to promptly access the most effective treatment – generic or branded - for epilepsy and seizures, by ensuring that patient needs prevail over “one size fits all” approaches to medication management.

ARGUMENTS IN OPPOSITION: The California Association of Health Plans (CAHP) writes it is opposed unless amended to this bill. CAHP argues this bill allows for an enrollee to request an expedited appeal process; however, no additional information regarding the enrollee is required to be submitted by the physician. In order to appropriately and effectively re-evaluate the use of the non-formulary drug, health plans require additional supporting documentation from the physician. CAHP states the absence of additional supporting documentation during the expedited review deflates the integrity of the expedited review process because pharmacy managers will not have any new and relevant supporting documentation. CAHP concludes that, in order for health plans to vigorously review non-formulary requests, additional information must be required from physicians.

ASSEMBLY FLOOR: 78-0, 6/3/15

AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins

NO VOTE RECORDED: Jones-Sawyer, Thurmond

Prepared by: Scott Bain / HEALTH /

8/31/15 8:33:21

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 68 (Waldron) - Medi-Cal

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

AB 68 would entitle Medi-Cal beneficiaries to an urgent appeal when a Medi-Cal managed care plan denies coverage for a drug prescribed to treat seizures or epilepsy because the drug is not on the managed care plan’s drug formulary.

Fiscal Impact:

• Likely one-time costs of up to $150,000 to make administrative changes by the Department of Health Care Services (General Fund and federal funds). The Department indicates that it would need to update existing regulations, managed care plan contracts, Notice of Action forms, and appeals reporting templates.

• Likely minor costs to monitor Medi-Cal managed care plan compliance with the bill’s requirements by the Department of Health Care Services.

• Unknown impact on the cost to provide prescription drugs by Medi-Cal managed care plans (General Fund and federal funds). Managed care plans create drug formularies as a way to control costs, by selecting low cost drugs and by increasing their bargaining power with drug companies. By creating a new appeals process to provide increased access to drugs that are not on Medi-Cal manage care plans’ drug formularies, the bill may increase patient access to more expensive drugs and/or reduce the managed care plans’ ability to negotiate discounts and rebates with drug manufacturers. The extent to which this will increase spending on prescription drugs is unknown.

Background:

The Medi-Cal program is a health care program for low-income individuals and families who meet defined eligibility requirements. Medi-Cal coordinates and directs the delivery of health care services to approximately 12 million qualified individuals, including low-income families, seniors and persons with disabilities, children in families with low-incomes or in foster care, pregnant women, low-income people with specific diseases, and, as of January 1, 2014, due to the Affordable Care Act, childless adults up to 138% of the federal poverty level.

About 80% of Medi-Cal beneficiaries are enrolled in Medi-Cal managed care plans. Medi-Cal managed care plans are required by federal and state law and contracts with the Department of Health Care Services to cover medically necessary prescription drugs. In general, Medi-Cal managed care plans are required to provide coverage for each mechanism of action sub-class within all major therapeutic categories of prescription drugs. In other words, Medi-Cal managed care plans must provide coverage for at least one type of drug in each category for specific uses. Medi-Cal managed care plans are not required to cover every single FDA approved drug for each approved use. Medi-Cal managed care plans, like most managed care plans, use a variety of methods to control the cost of providing prescription drug coverage. Medi-Cal managed care plans use drug formularies, in which the plan lists the specific drugs that are covered for specific conditions. By developing a drug formulary, the managed care plan can select lower cost drugs in specific categories and/or increase the plan’s ability to negotiate discounts or rebates with drug companies in exchange for listing a specific drug on the formulary. Similarly, Medi-Cal managed care plans may use a prior authorization process for certain, high cost drugs or may require beneficiaries to try less expensive drugs before being given access to more expensive drugs (referred to as “step therapy” or “fail first protocols”).

Under current law and contracts with the Department, Medi-Cal managed care plans and the state have several appeals processes in place to allow Medi-Cal beneficiaries to contest a decision by a Medi-Cal managed care plan. For example, a dissatisfied beneficiary can file a grievance with the managed care plan, request a fair hearing from the Department, or can file a grievance with the Department of Managed Health Care (for Medi-Cal managed care plans regulated by that department, which does not include most county operated health systems).

Proposed Law:

AB 68 would entitle Medi-Cal beneficiaries to an urgent appeal when a Medi-Cal managed care plan denies coverage for a drug prescribed to treat seizures or epilepsy because the drug is not on the managed care plan’s drug formulary. An urgent appeal could be requested by the beneficiary or the prescribing provider on the beneficiary’s behalf. The bill would require the Medi-Cal managed care plan to resolve the appeal within 24 hours.

Related Legislation:

• AB 73 (Waldron) would have required a drug from one of four classes to be covered by Medi-Cal if the drug was not on a Medi-Cal managed care plan’s formulary. That bill was held on the Assembly Appropriations Committee’s Suspense File.

• AB 339 (Gordon) would make several changes to existing law regarding prescription drug coverage and cost sharing for patients. That bill is on this committee’s Suspense File.

• AB 374 (Nazarian) would prohibit health plans or insurers from using step therapy or fail first protocols to beneficiaries who have made an override request. That bill is on this committee’s Suspense File.

• AB 1162 (Holden) would require tobacco cessation services to be a covered benefit in the Medi-Cal program. That bill is on this committee’s Suspense File.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 68

SUBJECT: Medi-Cal.

SUMMARY:

Requires a Medi-Cal beneficiary to be entitled to an automatic urgent appeal, as defined, when a Medi-Cal managed care plan denies coverage for a drug prescribed for the treatment of seizures and epilepsy that is approved by the Food and Drug Administration (FDA) for the use in the treatment of seizures and epilepsy if the patient’s treating provider demonstrates that in his or her reasonable, professional judgment, the drug is medically necessary and consistent with FDA labeling and use rules and regulations, as supported in at least one of the official compendia, and the drug is not on the formulary of the Medi-Cal managed care plan.

Existing law:

1. Establishes the Medi-Cal program, administered by the Department of Health Care Services (DHCS), under which basic health care services are provided to qualified low-income persons.
   
   

2. Requires the mandatory enrollment of specified Medi-Cal beneficiaries into Medi-Cal managed care plans.

3. Requires a Medi-Cal managed care plan that has prescription drugs as one of its benefits and that enters into a contract with DHCS to ensure the timely and efficient processing of authorization requests for drugs, when prescribed for plan enrollees, that are covered under the terms of the plan’s contract with DHCS and which require prior authorization from the plan, by providing both of the following:

   1. A response within 24 hours or one business day to a request for prior authorization made by telephone or other telecommunication device.

   2. The dispensing of at least a 72-hour supply of a covered outpatient drug in an emergency situation.

4. Requires, pursuant to regulation, Medi-Cal applicants or beneficiaries to have the right to a state hearing (known as a “fair hearing”) if dissatisfied with any action or inaction of the county department, DHCS or any person or organization acting in behalf of the county or DHCS relating to Medi-Cal eligibility or benefits.
   
   

5. Requires each Medi-Cal beneficiary to be informed in writing, at the time of application to Requires health plans licensed under the Knox-Keene Act (Medi-Cal plans, with the exception of county organized health systems [COHS] and PACE plans are required to be Knox-Keene licensed) to do all of the following:
   
   

   1. Establish and maintain a grievance system approved by the Department of Managed Health Care (DMHC), under which enrollees may submit their grievances to the plan. Requires an expedited plan review of grievances for cases involving an imminent and serious threat to the health of the patient, including, but not limited to, severe pain, potential loss of life, limb, or major bodily function;

   2. Maintain an expeditious process by which prescribing providers may obtain authorization for a medically necessary non-formulary prescription drug; and,

   3. Provide an enrollee with the opportunity to seek an independent medical review (IMR) whenever health care services have been denied, modified, or delayed by the plan, or by one of its contracting providers, if the decision was based in whole or in part on a finding that the proposed health care services are not medically necessary.

This bill:

1. Requires, to the extent permitted by federal law, if any drug used in the treatment of seizures and epilepsy is prescribed by a Medi-Cal beneficiary’s treating provider for the treatment of seizures and epilepsy, and coverage for that prescribed drug is denied by a Medi-Cal managed care plan in which the beneficiary is enrolled, that denial to be reviewed in accordance with this bill.

2. Requires the denial by a Medi-Cal managed care plan of a drug prescribed for the treatment of seizures and epilepsy that is approved by the FDA for the use in the treatment of seizures and epilepsy to be subject to the automatic urgent appeal process, if:

1. The treating provider demonstrates, consistent with federal law, that in his or her reasonable, professional judgment, the drug is medically necessary and consistent with the federal FDA’s labeling and use rules and regulations, as supported in at least one of the official compendia; and,

2. The drug is not on the formulary for the Medi-Cal managed care plan.

3. Requires a Medi-Cal beneficiary to be entitled to an automatic urgent appeal in a case in which a plan denies coverage for a drug prescribed for the treatment of seizures and epilepsy and approved by the FDA for the use in the treatment of seizures and epilepsy.

4. Defines an “automatic urgent appeal” as an appeal in which the Medi-Cal managed care plan immediately notifies DHCS of the denial of coverage, and the beneficiary is not required to take any further action.

5. Requires an automatic urgent appeal to be resolved within 48 hours after denial by the plan. Requires the 48-hour period to be in addition to any time prescribed by federal law.

6. States legislative intent that a Medi-Cal beneficiary have prompt access to medically necessary drugs for use in the treatment of seizures and epilepsy that have been approved by the FDA for use in the treatment of seizures or epilepsy, including drugs that are not on the formulary of a Medi-Cal managed care plan or that are subject to prior authorization. Requires this bill be known as the “Patient Access to Prescribed Epilepsy Treatments Act.”

FISCAL EFFECT:

According to the Assembly Appropriations Committee, unknown, likely minor, potential increased administrative costs for the fee-for-service Medi-Cal, and cost pressure to managed care, for an additional number of appeals.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, epilepsy is life-threatening and the first treatment is typically the best chance to get the disease under control. Formularies and step-therapy programs are not always sufficient to treat certain vulnerable populations. New pharmaceuticals and treatments are emerging rapidly, while insurance formularies do not have the capacity to keep up. In the meantime, patient care is being affected and individuals are losing access to receive the best pharmaceuticals that may control their condition sooner rather than later. Current formulary restrictions have multiple appeals processes patients have to go through. Step therapy correspondingly delays the patient from obtaining the most suitable drug combinations for their case.
   
   

2. Background on epilepsy. According to the Centers for Disease Control and Prevention, epilepsy is a disorder of the brain that causes seizures. These seizures are not caused by a temporary underlying medical condition such as a high fever. Epilepsy can affect people in very different ways as there are many causes and many different kinds of seizures. Some people may have multiple types of seizures or other medical conditions in addition to epilepsy. These factors play a major role in determining both the severity of the person’s condition and the impact it has on his or her life. The way a seizure looks depends on the type of seizure a person is experiencing. Some seizures can look like staring spells. Other seizures can cause a person to collapse, shake, and become unaware of what is going on around them. Epilepsy can be caused by different conditions that affect a person's brain. For two in three people, the cause of epilepsy is unknown. Some causes include stroke, brain tumor, traumatic brain injury or head injury or central nervous infection. A person with epilepsy is not contagious and cannot give epilepsy to another person. According to the latest estimates, about 1.8% of adults aged 18 years or older have had a diagnosis of epilepsy or seizure disorder.
   
   

3. Prescription drug coverage and appeal rights in managed care. The 2015-16 DHCS budget assumes average monthly enrollment in Medi-Cal of 12.4 million individuals, of whom 9.5 million individuals, or 76.6%, will enroll in Medi-Cal managed care plans. By contract, Medi-Cal managed care plans are required to cover prescription drugs except for those drugs which are “carved out” and reimbursed through fee-for-service (FFS) Medi-Cal (“carved out” drugs are typically costly). Plans are contractually required to submit to DHCS a complete formulary, and to report changes to the formulary to DHCS upon request and on an annual basis. A plan’s formulary is required to be “comparable” to the Medi-Cal FFS list of contract drugs, with “comparable” defined as the plan’s formulary must contain drugs which represent each mechanism of action sub-class within all major therapeutic categories of prescription drugs included in the Medi-Cal FFS List of Contract Drugs. Medi-Cal managed care plans (and their contracting pharmacy benefit managers) use formularies, prior authorization and utilization controls to control costs, ensure appropriate utilization and obtain rebates from drug manufacturers. Medi-Cal managed care plans are required to meet state law, federal law and contractual provisions relating to prescription drug coverage and appeal rights. This includes an expedited process for the plan grievance process for cases involving an imminent and serious threat to the health of the enrollee, and through the Department of Social Services (DSS) fair hearing process.
   
   

4. Related legislation. AB 73 (Waldron), would have required a drug from one of four classes of drugs to be covered by Medi-Cal if the treating provider demonstrates, that in his or her reasonable, professional judgment, the drug is medically necessary and consistent with the FDA’s labeling and use rules and regulations, and the drug is not on the formulary for the Medi-Cal managed care plan. AB 73 was held on the Assembly Appropriations Committee Suspense File.
   
   

AB 339 (Gordon) requires health plans and health insurers that provide coverage for outpatient prescription drugs to demonstrate that their formularies do not discourage the enrollment of individuals with health conditions. Requires for combination drug treatments that include antiretrovirals, coverage of a single-tablet that is as effective as a multitablet regimen unless a plan or insurer can demonstrate that the multitablet regimen is clinically equally or more effective and more likely to result in adherence to a drug regimen.  Requires individual market formulary coverage to be the same or comparable to formularies maintained in the group market. Places in state law, federal requirements related to prior authorization response times, pharmacy and therapeutics committees, access to in-network retail pharmacies, standardized formulary requirements. Applies step therapy requirements to health insurers that are currently applicable to health plans through state regulations. Places in state law formulary tier requirements similar but slightly different than those required of health plans and insurers participating in Covered California and copayment caps of $250 for a supply of up to 30 days for an individual prescription, as specified, consistent with those adopted by Covered California. AB 339 is scheduled to be heard in the Senate Health Committee on July 15, 2015.

AB 374 (Nazarian) prohibits a health plan or insurer that provides coverage for medications pursuant to a step therapy or fail-first protocol from applying that requirement to a patient who has made a step therapy override determination request if, in the professional judgment of the prescribing provider, the step therapy or fail-first requirement would be medically inappropriate for that patient, as specified. AB 374 is scheduled to be heard in the Senate Health Committee on July 15, 2015.

AB 1162 (Holden), requires tobacco cessation services to be a covered benefit under the Medi-Cal program. Requires the benefit to include unlimited quit attempts with no required break between attempts, at least four tobacco cessation counseling sessions per quit attempt, and a 90-day treatment regimen of any prescription or over-the-counter medication approved by the federal Food and Drug Administration for tobacco cessation that was covered under the Medi-Cal program as of January 1, 2015. Prohibits tobacco cessation medication coverage for drugs covered under Medi-Cal as of January 1, 2015, from being subject to any barriers, requirements, or restrictions, including, but not limited to, prior authorization. AB 1162 is in the Senate Appropriations Committee.

5. Prior legislation. AB 889 (Frazier, 2013), would have prohibited plans and health insurers from requiring a patient to try and fail on two medications before allowing the patient access to the medication originally prescribed by the patient's medical provider. AB 889 was held on the Suspense File of the Senate Appropriations Committee.
   
   

AB 369 (Huffman, 2012), would have prohibited health plans and insurers that restrict medications for the treatment of pain from requiring a patient to try and fail on more than two pain medications before allowing the patient access to the pain medication, or generically equivalent drug, prescribed by the provider. The Governor vetoed AB 369 because it did not strike “the right balance between physician discretion and health plan or insurer oversight. A doctor's judgment and a health plan's clinical protocols both have a role in ensuring the prudent prescribing of pain medications. Independent medical reviews are available to resolve differences in clinical judgment when they occur, even on an expedited basis. If current law does not suffice - and I am not certain that it doesn't, any limitations on the practice of “step therapy” should better reflect a health plan or insurer's legitimate role in determining the allowable steps.”

AB 1826 (Huffman, 2010), would have required plans and health insurers that cover outpatient prescription drug benefits to provide coverage for a drug that has been prescribed for the treatment of pain. AB 1826 would have prohibited health plans and insurers from requiring the subscriber or enrollee to first use an alternative prescription drug or an over-the-counter drug, as specified. AB 1826 was held on the Suspense File of the Senate Appropriations Committee.

AB 1144 (Price, 2009), would have required plans and health insurers that provide prescription drug benefits to submit written reports about step therapy each year to DMHC and CDI. AB 1144 was held on the Suspense File of the Assembly Appropriations Committee.

6. Support. Epilepsy California writes in support that for the majority of people living with epilepsy, anti-epilepsy medications (anticonvulsants) are the most common and most cost effective treatment for controlling and/or reducing seizures. But there is no “one-size fits all” treatment option for epilepsy, and the response to epilepsy medications can be different for each person. Physicians must be able to use their reasonable, professional judgment to prescribe FDA-approved medications that are best for each patient, and patients must gain timely access to these medications without enduring a lengthy appeal process. Epilepsy California writes that timely access to the most appropriate medications to control their seizures will go a long way to reduce Medi-Cal patients’ admissions for emergency room intervention.

Sunovion Pharmaceuticals (Sunovion) writes in support that this measure will help ensure patient access to medically necessary treatment and care for seizures and epilepsy and establishes a clear policy that will translate across all managed care plans and help ensure that Medi-Cal patients have equal access to drugs best suited to treat this serious condition. Sunovion writes that without access to medically necessary medications, patients are subjected to uncoordinated and inappropriate treatment patterns often leading to non-adherence and ultimately hospitalization. Sunovion states that numerous studies have found that limiting access to treatment options for epilepsy does not reduce overall health care costs. Studies have shown that the primary driver of direct costs associated with epilepsy treatment are attributed to medical costs rather than anti-epileptic drug costs. Sunovion writes that maintaining seizure control requires careful evaluation and monitoring by the physician and patient, and physicians treating epilepsy must be able to prescribe drugs that are best for each patient, based on independent clinical judgment, and this bill would establish a policy where a prescriber's reasonable professional judgment has the opportunity to prevail when prescribing a product for such a serious condition. This measure will help ensure patients in the Medi-Cal program will be able to promptly access the most effective treatment – generic or branded - for epilepsy and seizures, by ensuring that patient needs prevail over “one size fits all” approaches to medication management.

7. Oppose unless amended. The California Association of Health Plans (CAHP) writes it is opposed unless amended to this bill. CAHP states this bill allows for an expedited appeal process; however, no additional information regarding the enrollee is required to be submitted by the physician. CAHP states that, in order to appropriate and effectively re-evaluate the use of the non-formulary drug, health plans require additional supporting documentation from the physician. The absence of additional supporting documentation during the expedited review deflates the integrity of the expedited review process because pharmacy managers will not have any new and relevant supporting documentation. CAHP concludes that, in order for health plans to vigorously review non-formulary requests additional information must be required from physicians.
   
   

8. Policy issues.

   1. Automatic urgent appeal and 48 hour timeframe. Medi-Cal beneficiaries can appeal a Knox-Keene licensed health plan denial by filing a grievance with the plan or by filing a fair hearing request. The grievance process includes an expedited process for a case involving an imminent and serious threat to the health of the enrollee (known as an urgent grievance). Plans are required to provide a written statement to DMHC and the complainant on the disposition or pending status of the urgent grievance within three calendar days of receipt of the grievance by the Plan. In addition, enrollees can appeal urgent grievances directly to DMHC.
      
      Medi-Cal managed care plans which require prior authorization for prescription drugs are required to provide a response within 24 hours or one business day to a request for prior authorization made by telephone or other telecommunication device. In addition, Medi-Cal managed care plans are required to provide for the dispensing of at least a 72-hour supply of a covered outpatient drug in an emergency situation.

This bill has a 48-hour timeframe. In addition, under the current appeals process, the burden is on the patient to appeal the decision. Under this bill, when a drug has been prescribed for the treatment of seizures and epilepsy that is approved by the federal FDA for use in the treatment of seizures and epilepsy that is denied by a plan, there would be an automatic appeal.

The automatic appeal would benefit Medi-Cal beneficiaries in that they would be relieved of the burden of filing grievances and appeals. The author’s office indicates the reason for this provision is that, for a patient with epilepsy who is potentially experiencing breakthrough seizures resulting from impeded access to medically necessary medication, none of the current appeal options is timely following the denial by the plan. In addition, the author indicates this bill is focused on unique and critical disease states that are not like other medical conditions because a breakthrough epileptic seizure can have significant psychosocial and physical consequences in employment, driving, and could lead to injury. However, the automatic appeal approach raises several policy questions, including:

1. Is there evidence the existing Medi-Cal appeal mechanisms for the denial of prescription medication are inadequate to warrant an automatic appeal as this bill proposes?

2. Should an automatic appeal only apply to FDA-approved drugs for the treatment of seizures and epilepsy?

3. If drug denials are subject to an automatic appeal, how does this affect Medi-Cal managed care plan cost control measures?
   
   

1. Entity making decision on the appeal unclear. Under this bill, if a plan denies coverage for an FDA-approved drug prescribed for the treatment of seizures and epilepsy, the beneficiary is entitled to an automatic urgent appeal. The “automatic urgent appeal” means the plan must immediately notify DHCS of the denial of coverage, and the beneficiary is not required to take any further action. An automatic urgent appeal is required to be resolved within 48 hours after denial by the plan. While DHCS is required to be notified of the denial, it is unclear if the entity making the determination on the automatic urgent appeal is DHCS or the plan. DHCS does not have an automatic urgent appeal mechanism for Medi-Cal managed care denials, and Medi-Cal fair hearing appeals are handled by DSS. Amendments are needed to clarify this provision.

SUPPORT AND OPPOSITION:

Support: American Federation of State, County and Municipal Employees, AFL-CIO

Association of Regional Center Agencies

Biocom

California Chronic Care Coalition

California Healthcare Institute

California Life Sciences Association

Child Neurology Foundation

Disability Rights California

Epilepsy California

Sunovion Pharmaceuticals

Oppose: California Association of Health Plans (unless amended)

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 68

Author:(Waldron)

As Amended Ver:June 1, 2015

Majority vote

SUMMARY: Establishes that a beneficiary has a right to an urgent appeal process of a Medi-Cal managed care plan's denial of a drug used in the treatment of seizures and epilepsy and is a drug approved by the federal Food and Drug Administration for the treatment of seizures and epilepsy.

EXISTING LAW:

1. Requires states, under the federal Medicaid law, to have a drug use review program for covered outpatient prescription drugs, to ensure drugs are appropriate, medically necessary, and not likely to result in adverse medical effects. Federal law requires the program to assess data on drug use against predetermined standards, consistent with specified factors, including compendia.

2. Provides a schedule of benefits provided in the Medi-Cal program, including prescription drug benefits.

3. Authorizes the Department of Health Care Services to establish utilization controls for any Medi-Cal services as long as the controls are reasonably related to the purpose of establishing them. Allows the utilization controls include prior authorization, pre- and post-service audits, limitations on the number of services and review pursuant to professional standards.

FISCAL EFFECT: According to the Assembly Appropriations Committee, unknown, likely minor, potential increased administrative costs for the fee-for-service Medi-Cal, and cost pressure to managed care, for an additional number of appeals.

COMMENTS: The author argues this bill is a reasonable plan to stabilize those with life-threatening conditions by ensuring a timely appeal if there is a denial by a managed care plan. The author notes those who can afford private insurance plans have doctors who may have more time to work through the existing pre-authorization processes to attain a higher tier drug for their patients, however, those in vulnerable low-income situations are seeing their doctors most likely in clinics, where doctors are short on time and do not have the resources to follow-up on preauthorization appeals. The author concludes this bill levels the playing field for access to medically necessary drugs for low income patients with serious, chronic or life threatening conditions by granting them the right to an urgent appeal.

Medi-Cal is one of the largest drug purchasers in the state. The program spends about $4 billion on prescription drugs, including indirect expenditures through payment to managed care plans and direct expenditures in fee for service and for prescription drugs that are "carved out" of managed care. Carved out means that the state pays directly for the drug rather than indirectly through a capitated or fixed rate payment to a Medi-Cal managed care plan.

Facing significantly rising costs, the federal and state governments have grappled with various cost control measures. California, to help manage costs, has established a formulary for the fee-for service program. The formulary is not binding on Medi-Cal managed care plans, each of which creates their own formulary. A variety of utilization tools also are used. These include limiting prescriptions to six per month, although many beneficiaries receive more but only after a prior authorization has been approved. Frequent and high cost prescription drug users can be identified and case management interventions can be used if appropriate to reduce drug costs.

Epilepsy is a chronic disorder, the hallmark of which is recurrent, unprovoked seizures. Many people with epilepsy have more than one type of seizure and may have other symptoms of neurological problems as well. Although the symptoms of a seizure may affect any part of the body, the electrical events that produce the symptoms occur in the brain. The location of that event, how it spreads and how much of the brain is affected, and how long it lasts all have profound effects. These factors determine the character of a seizure and its impact on the individual. Having seizures and epilepsy can affect one's safety, relationships, work, driving and so much more. How epilepsy is perceived or how people are treated can become a bigger problem than the seizures.

Anti-epileptic drugs (AEDs) are the main form of treatment for people with epilepsy. And up to 70% people with epilepsy could have their seizures completely controlled with AEDs. There are around 25 AEDs used to treat seizures, and different AEDs work for different seizures.

Supporters note, on a prior version of this bill, that epilepsy is a serious medical condition that produces seizures and one seizure can have significant consequences, including head injury, limitations in driving or employment, hospitalization and sudden unexpected death. They argue that failure to effectively manage epilepsy and prevent breakthrough seizures results in higher costs to the Medi-Cal program and society through increased hospitalizations, relapses and deteriorating conditions which necessitate additional and expensive care.

There is no known opposition to this bill.

Analysis Prepared by: Roger Dunstan / HEALTH / (916) 319-2097 FN: 0000833

Date of Hearing: May 20, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

ABPCA Bill Id:AB 68

Author:(Waldron) – As Amended Ver:April 30, 2015

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill specifies access requirements for drugs used in the treatment of seizures and epilepsy. Specifically, this bill:

1. Requires if any drug used in the treatment of seizures and epilepsy prescribed by a Medi-Cal beneficiary’s provider to be covered in the Medi-Cal program.

2. Requires coverage of such drugs if a provider demonstrates in his or her reasonable professional judgment, the drug is medically necessary, and it is consistent with the federal Food and Drug Administration (FDA) labeling and use rules and regulations as described in at least one of the official compendia named in federal law.

3. Creates an automatic urgent appeal process.

FISCAL EFFECT:

1. Unknown costs and potential lost revenues, ranging from zero cost if this bill had no impact on the provision of pharmaceuticals in Medi-Cal, to hundreds of thousands of dollars annually (GF/federal) if the policy was implemented more liberally to allow greater prescriber control. Cost could vary dramatically depending on how this policy was operationalized.

For example, if stricter limits were placed on a managed care plan's ability to conduct utilization review, there could be significant cost pressure on Medi-Cal managed care rates for pharmaceutical benefits. This bill could lead to increased Medi-Cal costs in several ways: higher prices for drugs, reduced revenue from federal and state-negotiated rebates, and reduced revenue from the state's managed care tax if drugs were carved out of managed care.

Finally, the marketplace dynamics for various drug classes, prescriber behavior, and how pharmaceutical manufacturers respond to the market conditions created by this bill would also influence long-term costs.

2. Unknown, likely minor, potential increased administrative costs for the fee-for-service (FFS) Medi-Cal, and cost pressure to managed care, for an additional number of appeals.

3. Unknown offsetting cost savings, to the extent the bill is implemented robustly, in individual cases where prescribers' chosen medication prevents other medical complications. Such offsets, if any, would likely be a small percentage of increased costs.

COMMENTS:

1. Purpose. According to the author, this bill strengthens the doctor and patient relationship by legislating that a doctor's professional and reasonable judgment prevails, for purposes of epilepsy drugs within the Medi-Cal program.

2. Background. Drug benefits are provided through the FFS Medi-Cal delivery system, and through managed care. Managed care enrollees generally get their drugs through their managed care plan, which often subcontracts with a pharmaceutical benefits manager for provision of the drug benefit. Some drugs are carved out of managed care and only offered through the FFS system. Both managed care plans and the state maintain separate lists of preferred drugs, or formularies, and impose utilization controls on drugs not contained on the formulary. The most common controls include prior authorization (a request to a plan for coverage of a drug, which must be approved in order to fill a prescription) and step therapy (where the patient must try a different, often less expensive or more proven, drug before being prescribed the drug of choice). Utilization controls function in a variety of ways but are generally designed to impose friction between the prescribing of a drug and the filling of a prescription, offering the health plan the ability to examine cost-effectiveness and clinical appropriateness.

This bill would require FFS Medi-Cal and managed care plans to cover epilepsy drugs (anticonvulsants) for which a prescriber prescribes a drug in a manner consisted with FDA guidelines for use of the drug, and for which the prescriber demonstrates reasonable professional judgment that the drug is medically necessary.

3. Current Protections. Plans, and FFS Medi-Cal, are required to pay for all drugs deemed medically necessary, regardless of the formulary. Patients can contest denials of service through various means, including the state fair hearing/grievance process and through independent medical review. 2013 data indicates there were an estimated 550 annual state fair hearings held specific to prescription drug issues, out of a total of 5.8 million managed care enrollees, a rate of about one in 10,500 enrollees.

4. Clinical and Cost Concerns for Anticonvulsants. The fact this bill only applies to drugs listed on a compendia offers some protection against clinically inappropriate prescribing, but compendia also include various grades of evidence. Off-label use may be supported by compendia. According to individuals with expertise in managing pharmacy benefits, anticonvulsants are marketed and often used for conditions other than epilepsy and seizure disorders. The bulk of utilization review for anticonvulsants is directed to off-label use. In addition, a number of new drugs are in the development pipeline at this time, meaning costs for this category are projected to grow.

5. Support. Biotechnology firms and the California Chronic Care Coalition support this bill, noting individuals who require specific medications are forced to wait while they and their physicians are forced to wade through red tape and sometimes are forced to suffer with inadequate or contraindicated medications.

6. Opposition. The California Association of Health Plans (CAHP) opposes this bill, arguing it minimizes the role of care coordination plans employ to investigate safer alternatives and to help identify appropriate and inappropriate prescribing.

7. Staff Comments. This bill addresses an inherent tension between the state's interest in cost-effective provision of health care services and clinical oversight, and a prescriber's professional judgment on what will be optimal for each of his or her patients. The essential questions are whether these opposing concerns are appropriately balanced, and whether current policies and practices result in patient harm and the denial of needed care in a timely way.

Under current law, the state, health plans, and pharmaceutical benefit managers attempt to balance the medical needs of the patient and prescriber preferences with the provision of affordable benefits that meet clinical standards of appropriate care. In so doing, utilization review controls, such as prior authorization and step therapy, are employed. Prior authorization, for example, is not only employed to contain costs, but to allow a clinical review to ensure medication is prescribed appropriately and to allow consideration of safer alternatives. In some instances, inappropriate prescribing can be identified. Staff notes a policy favoring a prescriber's judgment may help certain patients in individual cases, but also has a potential for unintended consequences that could increase costs without providing a benefit to patients. For example, it may remove safeguards that prevent overprescribing or inappropriate prescribing.

Under this bill, the ease and convenience of the process to document medical necessity, and how much it deviates from the state's current process, would have a direct impact on drug utilization and costs. For example, if the very act of prescribing a drug that meets the FDA's labeling and use requirements is deemed adequate to meet medical necessity, there would likely be large utilization and cost impacts. To the extent additional controls are put in, it would have a lesser effect on utilization and cost.

8. Suggested Amendments. This bill was amended in Health committee to specify it applies to anticonvulsants only when used for treating seizure disorders. However, it does so by reference to intent language and should be clarified. Additionally, the author indicates the bill is simply intended to speed up the prior authorization review process to allow more prompt access to prescribed medications. If this is the case, and if the turnaround time is indeed unacceptable, staff suggests removing provisions related to coverage, medical necessity, and provider judgment altogether, and instead amend the bill to address the state FFS program and managed care contractual requirements related to timeline for prior authorization. Since medically necessary drugs are already covered pursuant to existing law and regulations, provided the prescriber demonstrates medical necessity in the required manner, addressing the timeline should be adequate to accomplish the intent.

9. Related Legislation.

1. AB 73 (Waldron), also being heard today, is similar to this bill and applies to four drug classes, including anticonvulsants.

2. AB 374 (Nazarian), pending on the Suspense File of this committee, specifies requirements with which health plan step therapy regimens must comply.

10. Prior Legislation.

1. AB 1814 (Waldron) of 2014 was similar to AB 73 and was held on this committee's Suspense File.

2. AB 889 (Frazier) of 2013 prohibited a health plan from requiring an enrollee to try and fail on more than two medications before allowing the enrollee access to the medication, or generically equivalent drug, as specified. This bill was held on the Senate Appropriations Committee suspense file.

3. AB 369 (Huffman) of 2012 would have prohibited carriers that restrict medications for the treatment of pain, pursuant to step therapy or fail-first protocol, from requiring a patient to try and fail on more than two pain medications before allowing the patient access to the pain medication, or generically equivalent drug, as defined, prescribed by the prescribing provider, as defined. AB 369 was vetoed by Governor Brown, who stated it did not strike the right balance between physician discretion and health plan or insurer oversight.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 21, 2015

ASSEMBLY COMMITTEE ON HEALTH

Rob Bonta, Chair

ABPCA Bill Id:AB 68

Author:(Waldron) – As Amended Ver:March 26, 2015

SUBJECT: Medi-Cal.

SUMMARY: Establishes that a prescriber’s reasonable professional judgment prevails over the policies and utilization controls of the Medi-Cal program, including the utilization controls of a Medi-Cal managed care plan, in prescribing a pharmaceutical that is in the seizure or epilepsy drug class. Specifically, this bill:

1. Requires any drug from the seizure or epilepsy drug class prescribed by a Medi-Cal beneficiary’s provider, the drug is to be covered in the Medi-Cal program.

2. Requires a Medi-Cal managed care plan to cover a seizure or epilepsy drug class if prescribed by a beneficiary's provider. Requires the provider to demonstrate reasonable professional judgment and that the drug is medically necessary and consistent with the federal Food and Drug Administration (FDA) labeling and use rules and regulations as described in at least one of the official compendia named in federal law.

3. Provides that if a Medi-Cal managed care plan chooses not to cover the specified drugs, the drugs are to be excluded from the plan's financial responsibility and covered on a fee-for-service basis and the plan's contracted rate shall be reduced accordingly.

EXISTING LAW:

1. Establishes in federal law the federal Medicaid program to provide comprehensive health benefits to low income persons.

2. Establishes the Medi-Cal program as California’s Medicaid program.

3. Requires states, under the federal Medicaid law, to have a drug use review program for covered outpatient prescription drugs, to ensure drugs are appropriate, medically necessary, and not likely to result in adverse medical effects. Federal law requires the program to assess data on drug use against predetermined standards, consistent with specified factors, including compendia.

4. Provides a schedule of benefits provided in the Medi-Cal program, including prescription drug benefits.

5. Authorizes the Department of Health Care Services (DHCS) to establish utilization controls for any Medi-Cal services as long as the controls are reasonably related to the purpose of establishing them. Allows the utilization controls include prior authorization, pre- and post-service audits, limitations on the number of services and review pursuant to professional standards.
   
   

6. Provides that any prescription drug approved by the FDA for the treatment of AIDS or an AIDS-related condition is automatically approved for placement on the contract list of Medi-Cal drugs. Allows the DHCS to apply utilization controls and conditions placement on the contract list on the manufacturer signing a rebate agreement with the federal Centers for Medicare and Medicaid Services (CMS).

7. Provides that any prescription drug approved by the FDA for the treatment of cancer is automatically approved for placement on the contract list of Medi-Cal drugs. Conditions placement on the contract list on the manufacturer signing a rebate agreement with CMS.

8. Excludes from managed care, by administrative guidance of DHCS, specified prescription drugs including those for HIV/AIDS and antipsychotics.

FISCAL EFFECT: This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, this bill, the Patient Access to Prescribed Epilepsy Treatments Act, strengthens the doctor and patient relationship by legislating that a doctor's professional and reasonable judgment prevails exclusively for epilepsy and seizure medications, to ensure patient access to these treatments. This bill, would require, to the extent permitted by federal law, that any drug in the seizure or epilepsy therapeutic drug class would be a covered benefit under the Medi-Cal program, more people move onto Medi-Cal managed care plans, we are essentially growing a two-tier system of healthcare. The author notes that current formulary restrictions have multiple appeals processes patients have to go through and step therapy correspondingly delays the patient from obtaining the most suitable drug combinations for their case. The author argues this bill is a reasonable plan to stabilize those with life-threatening conditions by ensuring access to care and protecting the doctor/patient relationship for low income individuals. The author notes those who can afford private insurance plans have doctors who may have more time to work through the existing pre-authorization processes to attain a higher tier drug for their patients, however, those in vulnerable low-income situations are seeing their doctors most likely in clinics, where doctors are short on time and do not have the resources to follow-up on preauthorization appeals. The author concludes this bill levels the playing field for access to medically necessary drugs for low income patients with serious, chronic or life threatening conditions by shortening the pre-authorization process for Medi-Cal doctors.

2. MEDICAID BACKGROUND. Medicaid is a federal-state program that pays for medical assistance for low-income individuals and families. Although pharmacy coverage is an optional benefit under federal Medicaid law, all states currently cover outpatient prescription drugs for all categorically eligible individuals and most other enrollees in their Medicaid programs.
   
   Most state Medicaid programs have adopted preferred drug lists (PDL, also called formularies), making any medication not deemed preferred subject to prior authorization. States use prior authorization, in conjunction with a PDL, to encourage the prescribing of the most clinically appropriate and cost-effective drug within a specific therapeutic drug category. Under federal law, non-preferred products must be made available through a review process that must provide a response within 24 hours and allow for a 72-hour supply of the drug in emergency situations. The complexity of the prior authorization process determines the extent to which it encourages trials of preferred medications first (i.e., step therapy).
   
   Step therapy requirements under Medicaid programs vary by state and by the prescribed drug or medical condition. Some states have broad step therapy requirements for program participants. For example, Pennsylvania has step therapy requirements for a wide variety of drugs, including protein pump inhibitors, anticonvulsants, anti-depressants, and others. Other states have narrower requirements. Georgia requires insureds to fail on two older forms of antipsychotic medications before receiving newer antipsychotic agents. Indiana has a step therapy requirement for anti-hypertensives (i.e., drugs used to address high blood pressure).
   
   According to the federal CMS, a compendium is a listing of FDA-approved drugs and biologics. A compendium includes a summary of the pharmacologic characteristics of each drug or biological, and may include information on dosage as well as recommended or endorsed uses in specific diseases. A recent change in federal law allows the Secretary of the federal Department of Health and Human Services to revise the statutory list of compendia as appropriate for identifying medical accepted indications for drugs used in an anti-cancer chemotherapeutic regimen in Medicare. Federal regulations establish a process for listing compendia for determining medically accepted uses of drugs in anti-cancer treatment, including a formal written request for changes to the list of compendia, publishing the list of the requests and soliciting public comment, considering the compendium’s attainment of the Medicare coverage advisory committee’s recommended desirable characteristics of compendia, and considering the compendium’s grading of evidence. Federal Medicaid law requires a drug use review program. The program is required to assess data on drug use against pre-determined standards, consistent with peer-reviewed medical literature and three statutorily listed compendia.

3. PRESCRIPTION DRUGS IN MEDI-CAL. Medi-Cal is one of the largest drug purchasers in the state. The program spends about $4 billion on prescription drugs, including indirect expenditures through payment to managed care plans and direct expenditures in fee for service and for prescription drugs that are “carved out” of managed care. Carved out means that the state pays directly for the drug rather than indirectly through a capitated or fixed rate payment to a Medi-Cal managed care plan.
   
   Drug spending has declined dramatically with the federal government taking greater financial responsibility with the advent of Medicare Part D drug coverage. California used to pay the prescription drug costs of dual eligibles, those individuals who were on Medi-Cal and Medicare. However, the spending on the remainder of beneficiaries has continued to rise at a rapid rate.
   
   Facing significantly rising costs, the federal and state governments have grappled with various cost control measures. California, to help manage costs, has established a formulary for the fee-for service program. The formulary is not binding on Medi-Cal managed care plans, each of which creates their own formulary. A variety of utilization tools also are used. These include limiting prescriptions to six per month, although many beneficiaries receive more but only after a prior authorization has been approved. Frequent and high cost prescription drug users can be identified and case management interventions can be used if appropriate to reduce drug costs.
   
   Another tool to help reign in the high costs of prescription drugs are the rebate programs. The federal government collects a rebate from prescription drug manufacturers. Manufacturers must pay a rebate to the federal government or Medicaid will not cover their prescription drug. California has been a national leader in the drug rebate program, being one of the first states to negotiate with manufacturers a “supplemental rebate” program. The program is so named because the rebate is a supplement to the federal rebate program. Manufacturers must agree to pay the state to have their prescription drug placed on a preferred drug list which usually means the drugs are available without prior authorization. At one time the state received over a billion dollars annually in net revenues through supplemental rebates. The implementation of Part D has led to significant decreases. In addition, with the increase in managed care, the state no longer bears the direct cost of paying for prescription drugs so supplemental rebates have declined more.
   
   

4. EPILEPSY AND SEIZURES. Epilepsy is a chronic disorder, the hallmark of which is recurrent, unprovoked seizures. Many people with epilepsy have more than one type of seizure and may have other symptoms of neurological problems as well. Although the symptoms of a seizure may affect any part of the body, the electrical events that produce the symptoms occur in the brain. The location of that event, how it spreads and how much of the brain is affected, and how long it lasts all have profound effects. These factors determine the character of a seizure and its impact on the individual. Having seizures and epilepsy can affect one's safety, relationships, work, driving and so much more. How epilepsy is perceived or how people are treated can become a bigger problem than the seizures.
   
   Anti-epileptic drugs (AEDs) are the main form of treatment for people with epilepsy. And up to 70% people with epilepsy could have their seizures completely controlled with AEDs. There are around 25 AEDs used to treat seizures, and different AEDs work for different seizures.
   
   Besides epilepsy there are a variety of conditions and substances can trigger seizures. Common causes include congenital abnormalities of the brain, illicit drug use, fever, brain tumors and metabolic imbalances, such as high levels of glucose or sodium. Although epilepsy is a common cause of seizures, most people who have a seizure have one that is caused by a reason other than epilepsy.
   
   

5. DRUG CLASSES. A drug class is a group of drugs that have something in common. They are similar in some way, but they are not identical. A drug also belongs to one or more drug classes. Drugs can be in a class with other drugs for several reasons:
   
   

   1. The drugs are related by their chemical structure;
      
      

   2. The drugs work in the same way; or,
      
      

   3. The drugs are used for the same purpose.

Drug class grouping then are fairly narrow. Drugs from a variety of classes are used to treat epilepsy and seizures.

6. NEW YORK PROVIDER PREVAILS LAW. In 2011, New York changed the process by which 4 million Medicaid recipients obtain prescription drug coverage. The pharmacy benefit was “carved in” to managed care instead of a fee for service program. This change resulted in patients losing many protections and has led to confusion, lack of uniformity in coverage.
   
   Patient advocates, health care providers and many members of the New York State Legislature began fighting to restore certain patient protections. Those protections including a comprehensive drug formulary, standardization of drug benefits, and maintaining the prescriber’s authority to decide what medicine a patient needs, frequently referred to as “prescriber prevails” In 2012, the advocacy effort resulted in restoration of “prescriber prevails” for atypical antipsychotics in the 2012-2013 Executive Budget (effective January 1, 2013). Later in 2013, the prescriber prevails provision was restored for all drug classes.
   
   

7. SUPPORT. Supporters note that epilepsy is a serious medical condition that produces seizures and one seizure can have significant consequences, including head injury limitations in driving or employment, hospitalization and sudden unexpected death. They argue that failure to effectively manage epilepsy and prevent breakthrough seizures results in higher costs to the Medi-Cal program and society through increased hospitalizations, relapses and deteriorating conditions which necessitate additional and expensive care. They conclude that the goal of treating an in individual with epilepsy is to have no seizures and no side effects and limiting availability of medications appears to be a simple way of controlling costs of patient care. Supporters conclude this approach potentially jeopardizes both efficacy and safety.

8. OPPOSITION. Health Access California opposes this bill because the approach in this bill eliminates the ability of the Medi-Cal program to bargain over drugs costs. They point out that since 1999 California has had a Medi-Cal formulary which has saved the state literally billions of dollars while providing consumers the drugs they need. Health Access also argues that the bill goes too far in its reliance on physician judgment as the sole determinant of what a patient needs, particularly in an environment in which Pharmaceutical manufacturers continue to engage in aggressive marketing of their products. Health Access also points out that under current law, the consumer has the right to medically necessary prescriptions. The California Association of Health Plans opposes AB 68 because it interferes with prior authorization. They argue that plans use prior authorization in conjunction with formulary management to encourage prescribing the most clinically appropriate and cost-effective drugs within specific therapeutic drug categories.

9. RELATED LEGISLATION. AB 73 (Waldron) of 2015, establishes that a prescriber’s reasonable professional judgment prevails over the policies and utilization controls of the Medi-Cal program, including the utilization controls of a Medi-Cal managed care plan, in prescribing a pharmaceutical from specified therapeutic drug classes. AB 73 is pending in this Committee.
   
   
   

10. PREVIOUS LEGISLATION.

    1. AB 1814 (Waldron) of 2014 was very similar to AB 73. AB 1814 was held on the Assembly Appropriations Suspense file.

2. AB 889 (Frazier) of 2013 prohibits a health plan from requiring an enrollee to try and fail on more than two medications before allowing the enrollee access to the medication, or generically equivalent drug, as specified. This bill was held on the Senate Appropriations Committee suspense file.

3. AB 369 (Huffman) of 2012 would have prohibited carriers that restrict medications for the treatment of pain, pursuant to step therapy or fail-first protocol, from requiring a patient to try and fail on more than two pain medications before allowing the patient access to the pain medication, or generically equivalent drug, as defined, prescribed by the prescribing provider, as defined. AB 369 was vetoed by Governor Brown, who stated:

While I sympathize with the author's good intentions, I am not convinced that this bill strikes the right balance between physician discretion and health plan or insurer oversight. A doctor's judgment and a health plan's clinical protocols both have a role in ensuring the prudent prescribing of pain medications. Independent medical reviews are available to resolve differences in clinical judgment when they occur, even on an expedited basis.

4. AB 1826 (Huffman) of 2010 would have required an insurer or health plan that covers prescription drug benefits to provide coverage for a drug that has been prescribed for the treatment of pain without first requiring the enrollee or insured to use an alternative drug or product. AB 1826 died on the Senate Appropriations Committee Suspense File.

11. POLICY COMMENT. This bill is among several that institute a policy of provider prevails as a way of easing patient's access to medications they believe are preferred. Bypassing the utilization controls of the plan, they may result in significant additional costs for the plan and perhaps for a patient. Epilepsy is a very serious condition and the possible impacts from seizures are significant and potentially life-threatening. An alternative approach the committee may want to consider is an expedited review by the plan, perhaps something along the lines of an automatic urgent appeal to be resolved within 48 hours.

12. PROPOSED AMENDMENT. The bill uses the term, “epilepsy and seizure therapeutic drug class.” This description encompasses many drugs and drug classes, including pharmaceuticals which have uses beyond the treatment of epilepsy and seizures. For example, anticonvulsants, or antiseizure medications, an important class of drugs for the treatment of epilepsy are increasingly used to treat bipolar disorder because of their effectiveness as a mood stabilizer. Given the language of the bill, a prescription to treat bipolar disorder with an anticonvulsant would be subject to the provisions of the prescriber prevailing over a plan’s formulary or other utilization controls. A mood stabilizer from another class of drugs would not be, which could distort prescribing decisions. Similarly valium would be subject to the prescriber prevailing regardless of the reason prescription was written because it can be prescribed as an anticonvulsant for seizure therapy, even though it is frequently prescribed as an antianxiety drug. So a person being prescribed valium by their physician would not be a decision subject to utilization controls, regardless if the prescription was for epilepsy or anxiety, but a person prescribed an antidepressant for anxiety would be subject to the plan’s utilization controls.

If the author’s intent is to ease access for those people being treated for epilepsy, the bill should be changed and wherever the term “if any drug in the seizure or epilepsy therapeutic drug class” should be replaced with “if any drug is used in the treatment of epilepsy.

REGISTERED SUPPORT / OPPOSITION:

Support

Child Neurology Foundation

Biocom

California Healthcare Institute

Sunovion Pharmaceuticals

Opposition

California Association of Health Plans
Health Access California

Analysis Prepared by: Roger Dunstan / HEALTH / (916) 319-2097