BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                    AB 2115


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          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


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          |                |     |Hernández, Holden,    |                    |
          |                |     |Quirk, Santiago,      |                    |
          |                |     |Weber, Wood           |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
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          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  








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          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  








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          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