BILL ANALYSIS Ó AB 2115 Page 1 ASSEMBLY THIRD READING AB 2115 (Wood) As Amended May 11, 2016 Majority vote ------------------------------------------------------------------ |Committee |Votes|Ayes |Noes | | | | | | | | | | | | | | | | |----------------+-----+----------------------+--------------------| |Health |19-0 |Wood, Maienschein, | | | | |Bonilla, Burke, | | | | |Campos, Chiu, | | | | |Dababneh, Gomez, | | | | | | | | | | | | | | |Roger Hernández, | | | | |Lackey, Nazarian, | | | | |Olsen, Patterson, | | | | |Ridley-Thomas, | | | | |Rodriguez, Santiago, | | | | |Steinorth, Thurmond, | | | | |Waldron | | | | | | | |----------------+-----+----------------------+--------------------| |Appropriations |14-0 |Gonzalez, Bloom, | | | | |Bonilla, Bonta, | | | | |Calderon, Daly, | | | | |Eggman, Eduardo | | | | |Garcia, Roger | | AB 2115 Page 2 | | |Hernández, Holden, | | | | |Quirk, Santiago, | | | | |Weber, Wood | | | | | | | | | | | | ------------------------------------------------------------------ SUMMARY: Requires health care service plans (health plans) and health insurers, when notifying enrollees who cease to be enrolled in health plans or insurance products about other health care coverage options, to also provide information about reduced-cost prescription drugs available through manufacturer patient assistance programs. It also requires information on locating free or reduced-cost programs for health care and prescription medications, such as through the Internet Web Site of the Office of the Patient Advocate. FISCAL EFFECT: Any impact to the Department of Managed Health Care and the California Department of Insurance is expected to be minor and absorbable. COMMENTS: This bill adds an additional disclosure to existing requirements notifying individuals, upon termination of coverage, of the availability of free or reduced prescription medicines prescription medicines through a manufacturer's patient assistance program (PAPs). The notice will also include a statement clarifying that assistance through a manufacturer's PAP does not constitute coverage under, and will not meet the requirements of the individual mandate under, the federal Patient Protection and Affordable Care Act. The Centers for Medicare and Medicaid Services note that pharmaceutical manufacturers may sponsor PAPs that provide financial assistance or drug free product (through in-kind product donations) to low income individuals to augment any AB 2115 Page 3 existing prescription drug coverage. PAPs can provide assistance to Part D enrollees and interface with Part D plans by operating "outside the Part D benefit" to ensure separateness of Part D benefits and PAP assistance. The PAP's assistance on behalf of the PAP enrollee does not count towards a Part D beneficiary's true-out-of-pocket cost (TrOOP). The calculation of TrOOP is important for determining whether an individual has reached the threshold for catastrophic coverage under the Part D benefit. A 2005 Publication of the Office of Inspector General (OIG) Special Advisory Bulletin on PAPs for Medicare Part D (Bulletin) noted that PAPs have long provided important safety net assistance to patients of limited means who do not have insurance coverage for drugs, typically serving patients with chronic illnesses and high drug costs. The OIG Bulletin noted that PAPs are structured and operated in many different ways, such as cash subsidies, free or reduced price drugs, or assistance directly to patients. Some PAPs replenish drugs furnished by pharmacies, clinics, hospitals, and other entities to eligible patients whose drugs are not covered by insurance manufacturers. The OIG Bulletin also indicated that some PAPs are affiliated with particular pharmaceutical manufacturers or independent charitable organizations without regard to any specific donor or industry interests. According to the National Conference of State Legislatures, prescription drug assistance has been a substantial and growing state interest for a number of years, generally in response to individuals who lack insurance coverage for medicines or who were not eligible for other government programs. In 1975, the first states began to authorize and fund direct subsidy programs. By 2009, a total of at least 42 states had established or authorized some type of program to provide pharmaceutical coverage or assistance; several of those are not currently operational. The subsidy programs, often termed "SPAPs," utilize state funds to pay for a portion of the drug AB 2115 Page 4 costs, usually for a defined population that meets enrollment criteria. In addition, an increasing number of states use discounts or bulk purchasing approaches that do not spend state funds for the drug purchases, identified as "Discount Programs." Since the passage of the Affordable Care Act, state legislatures have been less active on SPAP issues. This bill is supported by the biopharmaceutical industry, who indicates PAPs provide financial assistance for lifesaving drugs that otherwise may be inaccessible due to cost. Health plans and insurers oppose this bill, citing; 1) a lack of data on the effectiveness, purpose, and effect on overall drug costs; 2) concern about requiring one industry to promote the activities of another; 3) concern that promoting these programs can have the effect of driving up costs for individuals and employers purchasing health coverage; and 4) current law signed last year that already establishes strict out-of-pocket limitations on prescription drugs and shields individuals from the drugs' astronomical costs. Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0003010