BILL ANALYSIS Ó AB 369 Page 1 Date of Hearing: May 4, 2011 ASSEMBLY COMMITTEE ON APPROPRIATIONS Felipe Fuentes, Chair AB 369 (Huffman) - As Introduced: February 14, 2011 Policy Committee: HealthVote:13-5 Urgency: No State Mandated Local Program: Yes Reimbursable: No SUMMARY This bill prohibits health plans and health insurers from requiring a patient to try and fail on more than two pain medications before allowing the patient access to the pain medication, or its generic equivalent, prescribed by his or her physician. In addition, this bill grants the prescribing physician control over the duration of any fail-first trials, and allows the physician to prescribe the desired medication without further authorization from the plan or insurer once two trials have been conducted. FISCAL EFFECT 1)Negligible state fiscal effect associated with the mandate to cover the prescribed medication after two fail-first trials. According to the California Health Benefits Review Program (CHBRP), there is insufficient information to estimate a change in utilization or cost for enrollees whose prescribed medications may be subject to a fail-first protocol not compliant with this bill. Most medications are not subject to fail-first protocols and, for those that are, the majority of protocols appear to already be compliant with this bill. 2)Likely minor, if any, state fiscal impact associated with other provisions of the bill that allow physicians to control the duration of trials and streamline the plan's authorization process. CHBRP did not assess the fiscal impact of these provisions. 3)Federal regulations implementing the federal health reform AB 369 Page 2 law, the Patient Protection and Affordable Care Act (ACA) may impact the cost of this bill. Under current law, beginning in 2014 states will be liable for any additional cost related to state-level benefit mandates on plans offered through new health insurance exchanges that go beyond minimum federal requirements. At this time, it is unknown whether this bill might impose future state costs. COMMENTS 1)Rationale . According to the author, in order to reduce their costs and improve their profit margins, many health plans use step therapy or "fail first" policies which forces patients to try several alternative medications, which in some cases include over-the-counter medicines, before they are permitted to get the medication that their physician ordered. The author contends the duration of these step therapy protocols is left up to the insurance company or health plan and can last months. The author asserts that step therapy forces chronic pain patients to endure unnecessary physical and emotional suffering. 2)Fail-First Protocols . Proponents of fail-first protocols assert that it protects the health and safety of patients, as well as reduces health care spending, by ensuring that the most cost-effective and safest treatment is attempted first and that more costly and risky therapies are used only if necessary. Fail-first protocols are commonly used for certain higher-cost medications or medications with a shorter history of safety and effectiveness than the first-line alternatives. CHBRP's analysis indicates that health plans and insurers are extremely varied in their use of fail-first protocols for pain medication. For example, some enrollees affected by this bill have benefit coverage that is not subject to any fail-first protocol, and no single pain medication is subject to a fail-first protocol on every insurer's list. Some of the pain medications identified by CHBRP that require the use of fail-first protocols are controlled substances that the federal Drug Enforcement Agency (DEA) has determined have a high potential for abuse, although many are not. CHBRP also indicates fail-first protocols generally permit exceptions for intolerable side effects or contraindications. AB 369 Page 3 3)Mandates and the Affordable Care Act . The ACA creates new state-run health insurance exchanges that will likely provide coverage to millions of Californians, and requires that health plans offered through an exchange cover certain categories of benefits, called Essential Health Benefits (EHBs). The Secretary of Health and Human Services (HSS) is expected to publish guidance later in 2011 and 2012 that will further define these categories. These definitions will have important fiscal implications for the state. The ACA specifies that if states require plans in the exchange to offer additional benefits that go beyond the defined EHBs, then states must pay the additional cost related to those mandates. At this time, there are a number of outstanding questions related to how federally defined EHBs will interact with state-level benefit mandates. The ACA provisions related to EHB are silent on whether health plans offered through the exchange may use step therapy and fail-first protocols. Therefore, any potential future state cost impact from this mandate would be unknown until the design of EHBs, and the methodology used to determine state liability associated with state-level benefit mandates, are made clear. 1)Prior Legislation . AB 1826 (Huffman) in 2010 prohibited the use of fail-first protocols for pain medication altogether, instead of restricting the number of trials to two. CHBRP's analysis of AB 1826 indicated a Medi-Cal cost of approximately $10 million and increased premiums in the private market of $11 million. AB 1826 was held on the Suspense file of the Senate Appropriations Committee. 2)Other Mandates in the Current Session . There are fourteen health mandates that were introduced this year, including AB 369. Other mandates in the current session include: a) AB 72 (Eng): Acupuncture b) AB 137 (Portantino): Mammography c) AB 154 (Beall): Mental Health Services d) AB 171 (Beall): Autism e) AB 185 (Hernández): Maternity Services f) AB 310 (Ma): Prescription Drugs g) AB 369 (Huffman): Pain Prescriptions h) AB 428 (Portantino): Fertility Preservation i) AB 652 (Mitchell): Child Health Assessments AB 369 Page 4 j) AB 1000 (Perea): Cancer Treatment aa) SB 136 (Yee): Tobacco Cessation bb) SB 155 (Evans): Maternity Services cc) SB 173 (Simitian): Mammograms dd) SB 255 (Pavley): Breast Cancer Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081