BILL ANALYSIS Ó ------------------------------------------------------------ |SENATE RULES COMMITTEE | AB 389| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ 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, CONTINUED AB 389 Page 2 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 : CONTINUED AB 389 Page 3 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 CONTINUED AB 389 Page 4 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 CONTINUED AB 389 Page 5 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 CONTINUED AB 389 Page 6 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 CONTINUED AB 389 Page 7 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 CONTINUED AB 389 Page 8 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 **** END **** CONTINUED