BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date:July 6, 2011 |Bill No:AB | | |389 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Curren D. Price, Jr., Chair Bill No: AB 389Author:Mitchell As Amended:March 30, 2011 Fiscal:Yes SUBJECT: Bleeding disorders. SUMMARY: Establishes standards for the proper storage and delivery of blood clotting factor, a prescribed biologic, and other related equipment and supplies for home usage by people with hemophilia or other bleeding disorders. NOTE : This bill was heard in the Senate Committee on Health on June 22, 2011 and passed 8-0. Existing law: 1) Provides for the practice of pharmacy and the licensing and regulation of pharmacies, and pharmacists by the Board of Pharmacy (Board) within the Department of Consumer Affairs (DCA). 2) Specifies certain requirements regarding the 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 administer drugs and biologics pursuant to a prescriber's order. 4) Prohibits pharmacies from leaving, picking up from, accepting, or delivering prescriptions to 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. AB 389 Page 2 5) Creates the Holden-Moscone-Garamendi Genetically Handicapped Person's Program, which requires the Director of Health Services to establish and administer a program for the medical care of persons with genetically handicapping conditions, including hemophilia. This bill: 1)Creates the Standards of Service for Providers of Blood Clotting Products for Home Use Act (Act). 2) Establishes findings and declarations about bleeding disorders and treatment for bleeding disorders. 3) Specifies that the purposes of the Act is to establish standards of service for providers of blood clotting supplies and promoting access to a full range of essential blood clotting products and equipment for use at home by people with hemophilia and other bleeding disorders. 4) Applies definitions for the purpose of this Act, specifically: a) "Assay" as the amount of a particular constituent of a mixture or of the biological or pharmacological potency of a drug. b) "Ancillary infusion equipment and supplies" as the equipment and supplies required to infuse a blood clotting product into a human vein, including, but not limited to, syringes, needles, sterile gauze, field pads, gloves, alcohol swabs, numbing creams, tourniquets, medical tape, sharps or equivalent biohazard waste containers, and cold compression packs. c) "Bleeding disorder" as a medical condition characterized by a deficiency or absence of one or more essential blood clotting proteins in the human blood, often called "factors," including all forms of hemophilia and other bleeding disorders that result in uncontrollable bleeding or abnormal blood clotting without treatment. d) "Blood clotting product" as an intravenously administered medicine manufactured from human plasma or recombinant biotechnology techniques, approved for distribution by the federal Food and Drug Administration (FDA), that is used for the treatment and prevention of symptoms associated with bleeding disorders. e) "Emergency" as a situation in which a prudent layperson could AB 389 Page 3 reasonably believe that the consumer's condition requires immediate medical attention. f) "Hemophilia" as a human bleeding disorder caused by a hereditary deficiency of the Factors I, II, V, VIII, IX, XI, XII, or XIII blood clotting protein in human blood. g) "Hemophilia treatment center" as a facility for the treatment of bleeding disorders, including, but not limited to, hemophilia, that receives funding from federal government sources. h) "Home nursing services" as specialized nursing care provided in the home setting to assist a patient in the reconstitution and administration of blood clotting products. i) "Home use" as infusion or other use of a blood clotting product in a place other than a state-recognized hemophilia treatment center, including a home or physician's office. j) "Patient" as a person needing a blood clotting product for home use. aa) "Provider of blood clotting products for home use" as including but not limited to any hospital pharmacies, health system pharmacies, pharmacies affiliated with hemophilia treatment centers, specialty home care pharmacies, and retail pharmacies that provide blood clotting products for home use. Allows these providers to offer home nursing services for persons with bleeding disorders. Specifies that a health care service plan and all its affiliated providers are included as providers. 5)Provides that each provider of blood clotting products for home use shall meet all of the following requirements: a) Have sufficient knowledge and understanding of bleeding disorders and the medical and psychological management thereof, including, but not limited to, home therapy. b) Have access to a provider with sufficient clinical experience serving people with bleeding disorders so he or she knows when patients have an appropriate supply of clotting factor on hand and knows about proper refrigeration of clotting factors. c) Maintain 24-hour on-call service seven days a week for every day of the year, adequately screen telephone calls for AB 389 Page 4 emergencies, acknowledge all telephone calls within one hour or less and have access to knowledgeable pharmacy staff on call 24 hours a day in the event of need to provide emergency clotting factors. d) Have the ability to obtain all brands of blood clotting products approved by the FDA in multiple assay and vial sizes, including products manufactured from human plasma and those manufactured with recombinant biotechnology techniques, provided manufacturer supply exists and payer authorization is approved. e) Supply all necessary ancillary infusion equipment and supplies with each prescription, as needed. f) Store and ship, or otherwise deliver, all blood clotting products in conformity with all state and federally mandated standards, including, but not limited to, the standards set forth in the product's approved package insert. g) When home nursing services are prescribed by the treating physician, to offer these services either directly or through a qualified third party with experience in infusing bleeding disorders and coordinate pharmacy services with the third party when one is used to provide home nursing services. h) Upon receiving approved authorization for a non-emergency prescription, provided manufacturer supply exists, to ship the prescribed blood clotting products and ancillary infusion equipment and supplies to the patient within two business days or less for established and new patients. i) Upon receiving approved authorization to dispense a prescription for an emergency situation, provided manufacturer supply exists, to deliver prescribed blood products, ancillary infusion equipment and supplies, medications, and home nursing services to the patient within 12 hours for patients living within 100 miles of a major metropolitan airport, and within one day for patients living more than 100 miles from a major metropolitan airport. j) Provide patients who have ordered their products a designated contact phone number for reporting problems with a delivery and respond to these calls within a reasonable time period. aa) Provide patients notification of Class 1 and Class 2 recalls AB 389 Page 5 and withdrawals of blood clotting products and ancillary infusion equipment within 24 hours of the provider receiving notification and requires providers to participate in the National Patient Notification System for blood clotting product recalls. bb) Provide language translation services, over the phone or in person, as needed by the consumer. cc) Have a detailed plan for meeting their requirements in the event of a natural or manmade disaster or other disruption of normal business operations. dd) Provide appropriate and necessary recordkeeping and documentation as required by state and federal law and retain copies of the patient's prescriptions. ee) Comply with the privacy and confidentiality requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 6)Requires the Board to enforce and administer the provisions of the Act. 7)Clarifies that the Act does not apply to hospital pharmacies or health system pharmacies that dispense blood clotting products for emergency, urgent care, or inpatient encounters, or if an inpatient is discharged with a supply of blood clotting products for home use. FISCAL EFFECT: According to the Assembly Committee on Appropriations analysis dated April 13, 2011, this bill will result in minor absorbable workload to the California Board of Pharmacy to provide oversight related to requirements the bill establishes. COMMENTS: 1. Purpose. This bill is sponsored by the Hemophilia Council of California (Sponsor). According to the Author and Sponsor, there are currently no standards of service in state law governing the proper storage and delivery of blood clotting products and this bill will protect the health of people with coagulation disorders who use these products at home. 2. Background. According to information provided by the Sponsors, hemophilia is a rare, hereditary bleeding disorder affecting close to 17,000 people in the United States, about 4,000 of which live in California. Von Willebrand disease, another bleeding disorder, AB 389 Page 6 affects about 360,000 Californians. People born with hemophilia have little or no clotting factor, the protein needed for normal blood clotting. Until the 1970s, people with severe hemophilia suffered from uncontrollable internal bleeding, orthopedic deformities and a shortened lifespan. Recent inventions and production of highly purified blood clotting factors have helped give additional quality of life to those living with bleeding diseases. Factor products on the market today are usually free from previous risks like HIV and hepatitis as a result of contaminated material. Bleeding diseases are not curable but are treatable, often through intraveneous (IV) injection or infusion of prescription blood clotting products several times per week. A variety of blood clotting products, produced by various pharmaceutical manufactures, can be prescribed so as 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, including storage at certain temperatures, and sensitivity to extreme exposure to light. The Centers for Disease Control (CDC) recommends timely access to hemophilia treatment and the products and services related to that treatment. Treatment is available to people with hemophilia and others suffering bleeding disorders at federally funded Hemophilia Treatment Centers (HTCs) or by prescription at pharmacies licensed in the state. The CDC reports that patients treated at HTCs significantly reduce their morbidity and mortality. There are over 140 HTCs in the nation which provide both diagnostic and treatment services to people with hemophilia and other bleeding disorders, combining the efforts of physicians, nurses, social workers, physical therapists, orthopedists and dentists to comprehensively serve patients. In California, many blood clotting product providers are specialty care pharmacies. While these pharmacies may specialize in the provision of treatments and supplies to individuals with specific chronic diseases, they are not licensed according to different standards than other pharmacies. 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. AB 389 Page 7 Various other states including California have attempted to establish standards for blood clotting products, including Massachusetts, Missouri, Pennsylvania and New Jersey. New Jersey enacted that state's "Standards of Care in Hemophilia Homecare Law" that was enacted in 2000. The primary issue was a requirement by insurers that people with hemophilia worked with certain home care companies with which they had contracts. The Hemophilia Association of New Jersey found that often times, not all home care companies were familiar with hemophilia care, needs, and complications. New Jersey now requires all insurance carriers that provide coverage for the home treatment of hemophilia to contract with home care providers that comply with certain minimum standards of care developed by their Department of Health & Senior Services, in consultation with the Hemophilia Association. Sponsors cite, as a need for a state standard, a recent situation in which a Northern California pharmacy delivered clotting factor product to a patient and left it on their doorstep where the product subsequently spoiled in the heat. The Author and Sponsor also note that pharmacies and other entities specializing in the delivery of blood clotting products for home use form a growing segment in California and standards will "benefit people with hemophilia and other bleeding disorders, as well as maintain the current cost effective model for care for future generations." The Sponsor also states that California needs to have equal standards for all companies distributing clotting factor in order to protect people with bleeding disorders from companies that may not properly store or distribute clotting factor. 3. Prior Similar Legislation. SB 971 (Pavley) of 2010, and SB 1594 (Steinberg) of 2008, were also almost identical to this bill. The bills stemmed from conversations between the Hemophilia Council of California and pharmacies that distribute blood clotting products for home use. SB 971 was vetoed by the Governor and SB 1594 was held in the Senate Committee on Appropriations. 4. Arguments in Support. Supporters like the California Medical Association and the California Society of Health-System Pharmacists believe that this bill will establish important standards for the storage and delivery of highly sensitive medication while also promoting access to cost effective, life-saving, products and related equipment. Baxter Healthcare , a global medical products and services company in support of universal standards for clotting products, indicates that due to the sensitivity of the blood clotting medication and related products, "suboptimal treatment may AB 389 Page 8 even lead to uncontrolled internal bleeding, crippling joint malfunction, and chronic pain." Taleeris Biotherapeutics , a producer of biological therapies from blood plasma, also support this bill, stating that they heartily agree with the bill's objective of standardizing the pharmacy requirement of serving both publicly-supported and private pay individuals needing clotting products. SUPPORT AND OPPOSITION: Support: Hemophilia Council of California (Sponsor) Baxter Healthcare California Medical Association California Pharmacists Association California Society of Health-System Pharmacists Community Healthcare Services CSL Behring Federal Hemophilia Treatment Centers, Region IX Grifols Hemophilia Foundation of Northern California Meyer Family Cellars National Cornerstone Healthcare Services Inc. Pfizer Plasma Protein Therapeutics Association Taleeris Biotherapeutics University of California, Davis Medical Center Walgreens Numerous individual pharmacies and individuals Opposition: None received as of June 28, 2011. Consultant:Sarah Mason