BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      



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          |SENATE RULES COMMITTEE            |                   AB 389|
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                                 THIRD READING


          Bill No:  AB 389
          Author:   Mitchell (D), et al.
          Amended:  3/30/11 in Assembly
          Vote:     21

           
           SENATE HEALTH COMMITTEE  :  8-0, 6/22/11
          AYES:  Hernandez, Strickland, Alquist, Anderson, Blakeslee, 
            De León, DeSaulnier, Wolk
          NO VOTE RECORDED:  Rubio

           SENATE BUSINESS, PROF. & ECON. DEVELOP. COMM.  :  8-0, 7/6/11
          AYES:  Price, Emmerson, Corbett, Correa, Hernandez, Negrete 
            McLeod, Vargas, Walters
          NO VOTE RECORDED:  Wyland

           SENATE APPROPRIATIONS COMMITTEE  :  Senate Rule 28.8

           ASSEMBLY FLOOR  :  78-0, 4/28/11 - See last page for vote


           SUBJECT  :    Bleeding disorders

           SOURCE  :     Hemophilia council of California


           DIGEST  :    This bill establishes requirements for providers 
          of blood clotting products for home use to treat hemophilia 
          and other bleeding disorders.

           ANALYSIS  :    Existing federal law requires the U.S. Food 
          and Drug Administration (FDA) to regulate the manufacture 
          of pharmaceuticals derived from blood and blood components, 
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          such as blood clotting products, including establishing 
          standards for those products for shipping, storage, and 
          delivery, inspecting the products, approving them for use 
          by patients, and recalling products that may be defective 
          or potentially harmful. 

           Existing state law  :

          1. Establishes various state programs, administered by the 
             Department of Health Care Services (DHCS), that provide 
             medical care for persons with certain genetically based 
             diseases, such as the Genetically Handicapped Person's 
             Program (GHPP).  GHPP provides medical care for 
             qualified adults with genetically handicapping 
             conditions, including hemophilia. Another program, the 
             California Children's Services Program (CCS), provides 
             health care for qualified children with various 
             diseases, including hemophilia or other bleeding 
             disorders.

          2. Requires pharmacies to be licensed by the California 
             Board of Pharmacy.  Requires that California pharmacies 
             meet specified statutory and regulatory requirements, 
             including those relating to proper storage, handling, 
             dispensing, and disposal of drugs, staff training 
             protocols, drug and supply inventory, labeling, and 
             maintenance of patient confidentiality.   

          3. Authorizes pharmacists to perform specified procedures, 
             in accordance with procedures developed by physicians 
             and health facility administrators, including ordering 
             or performing routine drug therapy-related patient 
             assessments, ordering laboratory tests, initiating or 
             adjusting a patient's drug regimen, and administering 
             drugs and biologics, such as blood clotting products, by 
             injection, pursuant to a prescriber's order.
            
          Existing state regulation prohibits pharmacies from 
          leaving, picking up, accepting, or delivering prescriptions 
          to or from any place not licensed as a retail pharmacy, 
          with certain exceptions, including a patient's residence or 
          workplace, or a licensed health facility, as specified. 

           This bill  :

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          1. Establishes the Standards of Service for Providers of 
             Blood Clotting Products for Home Use Act.

          2. Requires that providers of blood clotting products for 
             home use must: 

             A.    Have sufficient knowledge and understanding of 
                bleeding disorders and have access to sufficient 
                clinical expertise in providing services to persons 
                with bleeding disorders in order to assess the 
                adequacy of patients' supplies of clotting factor 
                and to properly store and refrigerate products.

             B.    Have 24-hour access to knowledgeable pharmacy 
                staff in order to fill emergency requests for 
                clotting factors. Also have on-call service 
                available 24 hours a day to handle emergency 
                requests for clotting factor, maintain on-call 
                services all day, every day of the year, screen 
                calls for emergencies, and respond to all calls 
                within one hour.  

             C.    Be able to obtain all brands of FDA-approved 
                clotting products in multiple ranges and sizes and 
                supply all necessary ancillary infusion equipment 
                and supplies with each prescription.

             D.    Store, ship, and deliver products in accordance 
                with the product's approved package insert and 
                state and federally mandated standards.

             E.    Provide home nursing services directly or 
                through a qualified third party as necessary and 
                determined by the treating physician.

             F.    Ship nonemergency prescription clotting products 
                and ancillary equipment within two business days 
                upon authorization, provided the manufacturer 
                supply exists.  Deliver clotting products, 
                medications, equipment and home nursing services 
                within 12 hours for patients living within 100 
                miles of a major airport and within 1 day for other 
                patients, upon authorization and provided the 

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                manufacturer supply exists.  Provide patients with 
                a contact number for reporting problems with their 
                delivery, and respond to calls within a reasonable 
                time period.

             G.    Alert patients to specified classes of recalls 
                and withdrawals of blood clotting products and 
                ancillary equipment, and participate in the 
                National Patient Notification System for product 
                recalls.

             H.    Provide language translation services as needed 
                by the patient.

             I.    Have a detailed plan for meeting these 
                requirements in the event of a natural disaster or 
                other disruption of normal business operations.

             J.    Comply with federal and state recordkeeping and 
                documentation requirements and federal privacy and 
                confidentiality requirements.

          3. Defines "provider of blood clotting products" as all of 
             the following pharmacies that dispense blood clotting 
             factors for home use: 

             A.    Hospital pharmacies.

             B.    Health system pharmacies.

             C.    Pharmacies affiliated with hemophilia treatment 
                centers.

             D.    Specialty home care pharmacies.

             E.    Retail pharmacies.

          4. Defines "provider of blood clotting product" to also 
             include a health care service plan and its affiliated 
             providers if the plan exclusively contracts with a 
             single medical group in a specific geographic area to 
             provide services to its enrollees.  

          5. Clarifies that providers of blood clotting products may 

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             provide home nursing services for persons with bleeding 
             disorders.

          6. Requires the state Board of Pharmacy to enforce this 
             bill's provisions.

          7. Establishes various definitions for purposes of this 
             bill.

          8. Makes various legislative findings and declarations 
             relating to establishing standards of service for 
             entities that deliver blood clotting products for home 
             use and promoting timely access to a full range of 
             essential, cost-effective, lifesaving blood clotting 
             products and high-quality services for home use for 
             persons with hemophilia and other bleeding disorders.

           Background  

           Blood clotting products  .  According to the National 
          Hemophilia Council, bleeding disorders may occur 
          spontaneously or after mild to severe trauma.  These 
          bleeding disorders are treated by replacing the missing 
          clotting factor in the blood by injecting additional blood 
          clotting factors into the bloodstream.  The timing and 
          severity of bleeding episodes are unpredictable, even for 
          patients on regularly scheduled treatment; thus providers 
          of clotting factor concentrates must be able to effectively 
          respond to varying frequency and dosing needs. 

          Clotting factors used to treat hemophilia are FDA-approved, 
          and may only be used with a prescription.  Clotting factors 
          may be found in whole blood, plasma, and recombinant 
          factors, which are made in a laboratory and do not use 
          human blood products.  A variety of blood clotting 
          products, produced by various pharmaceutical manufactures, 
          can be prescribed to temporarily replace the missing 
          clotting factors in order to prevent or correct bleeding 
          episodes.  To properly administer blood clotting factors, 
          patients must often use ancillary supplies and equipment, 
          such as syringes, tourniquets, gauze, and alcohol swabs.

          Blood clotting products are generally expensive, and 
          require special handling.  They should generally be stored 

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          at certain temperatures, and are sensitive to extreme 
          exposure to light.

           Hemophilia treatment centers (HTCs)  .  HTCs provide 
          comprehensive diagnostic and treatment services for 
          individuals with hemophilia and other bleeding disorders, 
          through interdisciplinary teams that include hematologists, 
          nurses, social workers, physical therapists, and 
          orthopedists.  HTCs provide patient education on self-care, 
          and approximately 90 percent of severe hemophilia patients 
          seen at HTCs self-infuse their clotting factors. HTCs are 
          federally funded, and provide care in accordance with goals 
          established by the U.S. Department of Health and Human 
          Services Maternal and Child Health Bureau, and the Centers 
          for Disease Control and Prevention, as well as standards 
          established by the National Hemophilia Foundation.  HTCs in 
          California don't directly dispense clotting factor, but 
          through the 340B federal drug pricing program, they have 
          contracts with outside pharmacies to distribute/dispense 
          clotting factor to patients in the home setting.
           
          Specialty care pharmacies  .  Many blood clotting product 
          providers in California are considered specialty care 
          pharmacies.  These pharmacies specialize in the provision 
          of treatments and supplies to individuals with specific 
          chronic diseases.  They generally concentrate their 
          services on their target patient population, rather than 
          providing services that meet the needs of the general 
          public.  Specialty care pharmacies must comply with all 
          statutory and regulatory requirements as traditional 
          pharmacies, but do not need to meet additional licensing 
          requirements in order to provide their specialty services. 
           
           Specialty pharmacies often ship or deliver blood clotting 
          products to the homes of individuals with hemophilia, and 
          other bleeding disorders, and when necessary, provide or 
          arrange for nursing services to patients who may need 
          assistance with infusion of the blood clotting products.

           Medi-Cal contracting requirement  .  As of July 1, 2010, 
          providers supplying blood clotting factors to patients in 
          Medi-Cal, CCS, and the GHPP must sign contracts with the 
          state indicating that they agree to meet standards similar 
          to the standards set forth in this bill.  According to 

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          information from DHCS, these specialty contracts for blood 
          factor products require participating providers to meet 
          various performance obligations with regard to pharmacy 
          provider staff knowledge; storage, handling, and delivery 
          of clotting factor concentrates and ancillary supplies; 
          processing of prescription orders; hours of operation and 
          access to staff; and recordkeeping, billing, and product 
          recalls.     

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

           SUPPORT  :   (Verified  8/15/11)

          Hemophilia Council of CA (source)
          Baxter Healthcare
          California Academy of Family Physicians
          California Medical Association
          California Pharmacists Association
          California Society of Health System Pharmacists
          Community Healthcare Services
          CSL Behring
          DLA Piper
          DRG Pharmacy LLC
          Federal Hemophilia Treatment Centers Region XI
          Grifols, Inc.
          Hemophilia Foundation of Northern California
          Herndon Pharmacy
          Meyer Family Cellars
          National Cornerstone Healthcare Services, Inc.
          Pfizer
          Red Chip Enterprises
          Talecris Biotherapeutics
          UC Davis Medical Center
          Walgreens

           ARGUMENTS IN SUPPORT  :    The Hemophilia Council of 
          California and the University of California at Davis, 
          Hemophilia Treatment Center claim that with the production 
          of highly purified blood clotting factors, people with 
          hemophilia have the opportunity to lead normal lives, free 
          of pain and crippling arthritis.  For most people with 
          these bleeding disorders, this necessitates intravenous 
          injection or infusion of prescription blood clotting 

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          products several times a week, generally at home.  This 
          bill establishes crucial standards of service for 
          pharmacies that deliver these blood clotting products to 
          people with hemophilia and other life-threatening bleeding 
          disorders in the home setting.  

          CSL Behring believes it is essential that people with 
          bleeding disorders receive timely access to the full range 
          of blood clotting therapies. When patients do not receive 
          optimal services from providers, there is potential for 
          painful and sometimes crippling injury to the joints and 
          organs.  CSL Behring asserts that the recommendations and 
          standards established by the National Hemophilia Foundation 
          and set forth in this bill are cost- effective and reduce 
          mortality and bleeding-related hospitalization.


           ASSEMBLY FLOOR  : 
          AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall, Bill 
            Berryhill, Block, Blumenfield, Bonilla, Bradford, 
            Brownley, Buchanan, Butler, Charles Calderon, Campos, 
            Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson, 
            Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani, 
            Galgiani, Garrick, Gatto, Gordon, Grove, Hagman, 
            Halderman, Hall, Harkey, Hayashi, Roger Hernández, Hill, 
            Huber, Hueso, Huffman, Jeffries, Jones, Knight, Lara, 
            Logue, Bonnie Lowenthal, Ma, Mansoor, Mendoza, Miller, 
            Mitchell, Monning, Morrell, Nestande, Nielsen, Norby, 
            Olsen, Pan, Perea, V. Manuel Pérez, Portantino, Silva, 
            Skinner, Smyth, Solorio, Swanson, Torres, Valadao, 
            Wagner, Wieckowski, Williams, Yamada, John A. Pérez
          NO VOTE RECORDED: Gorell, Vacancy


          CTW:do  8/16/11   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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