BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                     SB 447


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          Date of Hearing:  July 7, 2015


                            ASSEMBLY COMMITTEE ON HEALTH


                                  Rob Bonta, Chair


          SB  
          447 (Allen) - As Amended June 1, 2015


          SENATE VOTE:  27-4


          SUBJECT:  Medi-Cal: clinics: drugs and supplies.


          SUMMARY:  Revises the Medi-Cal and Family Planning, Access,  
          Care, and Treatment (Family PACT) reimbursement formula for  
          drugs and supplies dispensed by specified clinics.   
          Specifically, this bill:  

          1)Defines "cost" as the sum of the actual acquisition cost of a  
            drug or supply plus a clinic dispensing fee, for the purposes  
            of reimbursement by the Department of Health Care Services  
            (DHCS) to specified clinics for drugs and supplies covered  
            under the Medi-Cal program and Family PACT Waiver Program.  

          2)Requires the actual acquisition cost of a drug or supply to be  
            calculated at least once a year.  



          3)Defines the clinic dispensing fee as the difference between  
            the actual acquisition cost of a drug or supply and the  
            Medi-Cal reimbursement rate.  Removes caps to clinic  
            dispensing fees.








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          4)Requires the reimbursement provided by DHCS to be equal to the  
            amount billed or the Medi-Cal reimbursement rate, whichever is  
            less.



          5)Clarifies that clinics designated as federally qualified  
            health centers and rural health clinics are authorized to bill  
            and be reimbursed upon electing to be reimbursed for  
            pharmaceutical goods and services on a fee-for-service basis  
            that are specifically delivered through their dispensaries.



          EXISTING LAW:



          1)Establishes the Medi-Cal program under the direction of DHCS  
            to provide low-income qualifying individuals health care and a  
            uniform schedule of benefits.

          2)Establishes the Family PACT program under the direction of the  
            Office of Family Planning to provide eligible low-income  
            individuals comprehensive family planning services.



          3)Requires licensed community clinics, free clinics, and  
            intermittent clinics (clinics) to bill and be reimbursed for  
            drugs and supplies covered under the Medi-Cal program and  
            Family PACT Waiver Program at either cost or the clinic's  
            usual charge made to the general public, whichever is less.











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          4)Defines "cost" as both of the following:


             a)   An amount equal to the sum of the actual acquisition  
               cost of a drug or supply plus a clinic dispensing fee which  
               does not exceed $12 per billing unit, as defined; and,
             b)   The actual acquisition cost for that drug plus a clinic  
               dispensing fee, not to exceed $17 per prescription, for a  
               take-home drug that is dispensed for use by the patient  
               within a specific timeframe of five days or less from the  
               date medically indicated.



          5)Requires the reimbursement to be the Medi-Cal reimbursement  
            rate or the amount billed, whichever is less, and for  
            reimbursement to not exceed the net cost of these drugs or  
            supplies when provided by retail pharmacies under the Medi-Cal  
            program.

          6)Prohibits DHCS from subjecting a clinic to reimbursement  
            reductions based on a clinic's usual charge to the general  
            public, if a clinic either:  a) furnishes services free of  
            charge; b) furnishes services at a nominal charge, as defined  
            by federal law; or, c) can demonstrate, upon request, that it  
            serves primarily low-income patients, and its customary  
            practice is to charge patients based on their ability to pay.



          7)Authorizes clinics designated as federally qualified health  
            centers or rural health clinics to bill and be reimbursed if  
            they choose to be reimbursed for pharmaceutical goods and  
            services on a fee-for-service basis.



          8)Requires a clinic that is eligible to, but has not chosen to,  
            utilize drugs purchase under the federal drug discount program  








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            (340B Discount Drug Program) for its Medi-Cal patients, to  
            provide notification to the federal Health Resources and  
            Services Administration's Office of Pharmacy Affairs that it  
            is using non-340B drugs for its Medi-Cal patients in the  
            manner and to the extent required by federal law.



          FISCAL EFFECT:  According to the Senate Appropriations  
          Committee, increased annual costs of at least $6 million  
          (General Fund (GF)) and $19 million (federal funds) per year to  
          pay increased reimbursement rates for drugs covered by Medi-Cal.  
           Would modify the existing statutory limits on Medi-Cal  
          reimbursement for drugs dispensed by certain clinics.  In doing  
          so, this bill will increase the payment rates by the state for  
          certain drugs.  The cost estimates above are based on 2013-14  
          expenditures for contraceptive drugs and drugs covered under the  
          Medi-Cal and Family PACT program for contraceptive drugs and  
          drugs related to family-planning services.  Because this bill  
          does not specifically limit the increased reimbursement to those  
          types of drugs, it is possible that actual costs could be lager.  
           Minor administrative costs to revise existing payment rules and  
          procedures by DHCS (GF and federal funds).





          COMMENTS:


          1)PURPOSE OF THIS BILL.  According to the author, California's  
            1152 community health clinics offer a unique option for  
            low-income patients to receive quality, affordable medical  
            care.  The author contends clinics that dispense medication  
            onsite provide the additional convenience of allowing patients  
            to leave their health care provider with medication in hand.   
            The author maintains that this has led to improved access to  
            health care and better patient health outcomes.  The author  








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            explains the current billing system the clinics must use is  
            overly complex and leads to numerous billing errors which  
            require staff resources for both the clinics and the state.   
            The author states these errors can take months to resolve and  
            chronically deny clinics the fees to which they are entitled.

            The author points to existing law, stating community clinics  
            are currently allowed to receive a dispensing fee in addition  
            to the purchasing cost of the medications they dispense to  
            Medi-Cal and Family PACT patients, which enables and  
            encourages clinics to dispense medication onsite.  The author  
            states the original intent of the statutes related to clinic  
            dispensing fees was for clinics to recover the cost of storing  
            and dispensing the drugs and to provide clinics with funds to  
            either expand services or increase the number of patients they  
            could serve.  The author contends further clarity is needed to  
            define cost in existing law; in some cases clinics are only  
            reimbursed for the purchasing cost of a drug and without any  
            additional funds to cover the overhead needed to store the  
            drug or pay a provider to dispense it to patients.  The author  
            concludes this bill will clarify the obligation of DHCS to  
            provide a reasonable dispensing fee and specifically set that  
            fee.


            
          2)BACKGROUND.  

             a)   Physician-administered drugs.  A  
               physician-administered drug is any covered outpatient  
               drug provided or administered to a recipient, and  
               billed by a provider other than a pharmacy.  Such  
               providers include, but are not limited to, physician  
               offices, clinics, and hospitals.  A covered outpatient  
               drug is broadly defined as a drug that may be dispensed  
               only upon prescription, and is approved for safety and  
               effectiveness as a prescription drug under the Federal  
               Food, Drug and Cosmetic Act.  Physician-administered  
               drugs include both injectable and non-injectable drugs.  








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               AB 2151 (Jackson), Chapter 2051, Statutes of 2004,  
               provided a dispensing fee through Medi-Cal and Family  
               PACT for physician-administered drugs dispensed by a  
               community clinic, a free clinic or an intermittent  
               clinic.  Prior to the enactment of AB 2151, Medi-Cal  
               regulations prohibited a dispensing fee or mark-up for  
               take-home drugs dispensed by a clinic.  The  
               reimbursement provisions of AB 2151 were modified the  
               following year by AB 77 (Frommer), Chapter 503,  
               Statutes of 2005.  Drugs reimbursed under these  
               provisions are typically birth control medication (oral  
               contraception, emergency contraception and birth  
               control patches and rings) and antibiotics.



             b)   340B drug pricing program.  The 340B Drug Pricing  
               Program is a federal program that requires drug  
               manufacturers to provide outpatient drugs to eligible  
               health care organizations/covered entities at  
               significantly reduced prices.  The 340B Program enables  
               covered entities to stretch federal resources as far as  
               possible, reaching more eligible patients and providing  
               more comprehensive services.  The program provides  
               access to reduced price prescription drugs to over  
               16,869 health care facilities (as of October 2011)  
               certified by the U.S. Department of Health and Human  
               Services as covered entities.  These clinics, centers,  
               and hospitals in turn serve more than 10 million people  
               in all 50 states, plus commonwealths and territories.



             c)   Clinic reimbursements.  Under existing law, clinics  
               bill at the lower of cost or the usual charge to the  
               public.  "Cost" is defined to include a maximum  
               dispensing fee amount per unit of $12 (an example of a  








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               unit would be calendar month's supply).  There is a  
               separate maximum dispensing fee amount of $17 for  
               emergency contraception. 



             Existing law also requires DHCS to reimburse at the lower  
               of the amount billed or the Medi-Cal reimbursement  
               rate, except that reimbursement cannot exceed the net  
               cost of these drugs or supplies when provided by retail  
               pharmacies under the Medi-Cal program.  The sponsor of  
               this bill (Planned Parenthood Affiliates of California  
               PPAC)) indicates this bill deletes the reference to the  
               retail pharmacy cap as DHCS has not implemented this  
               cap.  The acquisition cost can vary by the type of  
               clinic purchasing (for example, some clinics may  
               receive volume discounts from drug manufacturers).   
               Dispensing fees vary by the type of drug or supply, but  
               not by type of clinic.  Under this bill, the clinic  
               dispensing fee is defined as the difference between the  
               actual acquisition cost of a drug or supply and the  
               Medi-Cal reimbursement rate.

          3)SUPPORT.  PPAC, the sponsor of this bill, state this bill will  
            streamline the process that community clinics use to bill and  
            be reimbursed for medications that are dispensed onsite.  The  
            sponsor maintains the current reimbursement process is  
            complicated and often takes month or years to complete,  
            leaving Planned Parenthood health clinics with millions of  
            dollars in outstanding reimbursements owed to them.  The  
            sponsor contends that maintaining a reimbursement system that  
            denies clinics a reasonable dispensing fee undermines the  
            ability of clinics to provide quality, low cost care to  
            patients who need it.  The sponsor concludes this bill will  
            simplify the existing reimbursement system by setting the  
            dispensing fee at the difference between the acquisition cost  
            and the Medi-Cal reimbursement rate, allowing clinics to bill  
            and be reimbursed at one rate.
          








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            Supporters of this bill state California's community clinics  
            and health centers offer a unique option for low-income  
            patients to receive quality, affordable medical care.   
            Supporters contend clinics that dispense medication onsite  
            provide patients with the added convenience of leaving their  
            health care provider with their medication in hand, which  
            removes barriers to care, increases access to care, and  
            improves health outcomes.  Supporters state this bill will  
            help provide consistent and equitable reimbursement to clinics  
            for the health care services they provide, and reduce the  
            administrative burden clinics face when dispensing medication.



          4)PREVIOUS LEGISLATION.

             a)   AB 2340 (Garcia) of 2014 was gutted and amended last  
               year in the Senate Health Committee with the contents of  
               the introduced version of this bill, but was never heard.

             b)   SB 77 revises the reimbursement formulary for federally  
               qualified health centers and rural health clinics.



             c)   AB 2151 establishes the reimbursement formulary for  
               community care clinics, free clinics, and intermittent  
               clinics that dispense prescription drugs in the Medi-Cal  
               and Family PACT program, including a dispensing fee for  
               physician-administered drugs.



          REGISTERED SUPPORT / OPPOSITION:




          Support








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          Planned Parenthood Affiliates of California (sponsor)


          California Primary Care Association


          Community Action Fund of Planned Parenthood of Orange and San  
          Bernardino Counties
          Community Clinic Association of Los Angeles
          Planned Parenthood Action Fund of the Pacific Southwest
          Planned Parenthood Action Fund of Santa Barbara, Ventura, and  
          San Luis Obispo Counties, Inc.
          Planned Parenthood Advocacy Project Los Angeles County
          Planned Parenthood Mar Monte 
          Planned Parenthood Northern California Action Fund
          Planned Parenthood Pasadena and San Gabriel Valley
          
          Opposition


          


          None on file.




          Analysis Prepared by:An-Chi Tsou / HEALTH / (916)  
          319-2097















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