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AB-389 Bleeding disorders.(2011-2012)

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AB389:v93#DOCUMENT

Assembly Bill No. 389
CHAPTER 75

An act to add Article 5 (commencing with Section 125286.10) to Chapter 2 of Part 5 of Division 106 of the Health and Safety Code, relating to genetic diseases.

[ Approved by Governor  July 10, 2012. Filed with Secretary of State  July 10, 2012. ]

LEGISLATIVE COUNSEL'S DIGEST


AB 389, Mitchell. Bleeding disorders.
Existing law, the Holden-Moscone-Garamendi Genetically Handicapped Person’s Program, requires the Director of Health Care Services to establish and administer a program for the medical care of persons with genetically handicapping conditions, including hemophilia.
This bill would impose specified requirements on providers of blood clotting products for home use, as described, whose products are used for the treatment and prevention of symptoms associated with bleeding disorders, including all forms of hemophilia. This bill would require the California State Board of Pharmacy to administer and enforce these provisions.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Article 5 (commencing with Section 125286.10) is added to Chapter 2 of Part 5 of Division 106 of the Health and Safety Code, to read:
Article  5. Standards of Service for Providers of Blood Clotting Products for Home Use Act

125286.10.
 This article shall be known, and may be cited, as the Standards of Service for Providers of Blood Clotting Products for Home Use Act.

125286.15.
 The Legislature hereby finds and declares all of the following:
(a) Hemophilia is a rare, hereditary, bleeding disorder affecting at least 4,000 persons in California and is a chronic, lifelong, and incurable, but treatable, disease.
(b) Von Willebrand disease is a human bleeding disorder caused by a hereditary deficiency or abnormality of the von Willebrand factor in human blood, which is a protein that helps clot blood. Von Willebrand disease is a chronic, lifelong, incurable, but treatable, disease affecting at least 360,000 Californians.
(c) Until the 1970s, people with severe hemophilia suffered from uncontrollable internal bleeding, crippling orthopedic deformities, and a shortened lifespan. More recently, the production of highly purified blood clotting factors has provided people with hemophilia and other bleeding disorders the opportunity to lead normal lives, free of pain and crippling arthritis.
(d) The preferred method of treatment of hemophilia today is intravenous injection, or infusion, of prescription blood clotting products several times per week, along with case management and specialized medical care at a federally designated regional hemophilia treatment center.
(e) Pharmacies and other entities specializing in the delivery of blood clotting products and related equipment, supplies, and services for home use form a growing enterprise in California.
(f) Timely access to federally designated regional hemophilia centers and appropriate products and services in the home, including infusion of blood clotting products and related equipment, and supplies and services for persons with hemophilia and other bleeding disorders, reduces mortality and bleeding-related hospitalizations according to the federal Centers for Disease Control and Prevention and the Medical and Scientific Advisory Council of the National Hemophilia Foundation.
(g) Eligible persons with hemophilia or other bleeding disorders may receive treatment through the Genetically Handicapped Persons Program, the California Children’s Services Program, and the Medi-Cal program.
(h) For the benefit of persons with hemophilia or other bleeding disorders, the purposes of this article are to do the following:
(1) Establish standards of service for entities that deliver blood clotting products and related equipment, supplies, and services for home use.
(2) Promote access to a full range of essential, cost-effective, lifesaving, blood clotting products and related equipment, supplies, and high-quality services for home use for persons with hemophilia and other bleeding disorders.

125286.20.
 Unless the context otherwise requires, the following definitions shall apply for purposes of this article:
(a) “Assay” means 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” means 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” means 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, without treatment, result in uncontrollable bleeding or abnormal blood clotting.
(d) “Blood clotting product” means an intravenously administered medicine manufactured from human plasma or recombinant biotechnology techniques, approved for distribution by the federal Food and Drug Administration, that is used for the treatment and prevention of symptoms associated with bleeding disorders. Blood clotting products include, but are not limited to, factor VII, factor VIIa, factor VIII, and factor IX products, von Willebrand factor products, bypass products for patients with inhibitors, and activated prothrombin complex concentrates.
(e) “Emergency” means care as defined in Section 1317.1.
(f) “Hemophilia” means 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” means a facility for the treatment of bleeding disorders, including, but not limited to, hemophilia, that receives funding specifically for the treatment of patients with bleeding disorders from federal government sources, including, but not limited to, the federal Centers for Disease Control and Prevention and the federal Health Resources and Services Administration (HRSA) of the United States Department of Health and Human Services.
(h) “Home use” means infusion or other use of a blood clotting product in a place other than a state-recognized hemophilia treatment center or other clinical setting. Places where home use occurs include, without limitation, a home or other nonclinical setting.
(i) “Patient” means a person needing a blood clotting product for home use.
(j) (1) “Provider of blood clotting products for home use” means all the following pharmacies, except as described in Section 125286.35, 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.
(2) The providers described in this subdivision shall include a health care service plan and all its affiliated providers if the health care service plan exclusively contracts with a single medical group in a specified geographic area to provide professional services to its enrollees.

125286.25.
 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 to accurately follow the instructions of the prescribing physician and ensure high-quality service for the patient and the medical and psychosocial management thereof, including, but not limited to, home therapy.
(b) Have access to a provider with sufficient clinical experience providing services to persons with bleeding disorders that enables the provider to know when patients have an appropriate supply of clotting factor on hand and about proper storage and 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 emergencies, acknowledge all telephone calls within one hour or less, and have access to knowledgeable pharmacy staffing on call 24 hours a day, to initiate emergency requests for clotting factors.
(d) Have the ability to obtain all brands of blood clotting products approved by the federal Food and Drug Administration in multiple assay ranges (low, medium, and high, as applicable) and vial sizes, including products manufactured from human plasma and those manufactured with recombinant biotechnology techniques, provided manufacturer supply exists and payer authorization is obtained.
(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 (PI).
(g) Upon receiving approved authorization for a nonemergency prescription, provided manufacturer supply exists, 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.
(h) Upon receiving approved authorization to dispense a prescription for an emergency situation, provided manufacturer supply exists, deliver prescribed blood products, ancillary infusion equipment and supplies, and medications 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.
(i) Provide patients who have ordered their products with a designated contact telephone number for reporting problems with a delivery and respond to these calls within a reasonable time period.
(j) Provide patients with notification of Class 1 and Class 2 recalls and withdrawals of blood clotting products and ancillary infusion equipment within 24 hours of the provider of blood clotting products for home use receiving notification and participate in the National Patient Notification System for blood clotting product recalls.
(k) Provide language interpretive services over the telephone or in person, as needed by the patient.
(l) Have a detailed plan for meeting the requirements of this article in the event of a natural or manmade disaster or other disruption of normal business operations.
(m) Provide appropriate and necessary recordkeeping and documentation as required by state and federal law and retain copies of the patient’s prescriptions.
(n) Comply with the privacy and confidentiality requirements of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).

125286.30.
 The California State Board of Pharmacy shall administer and enforce this article.

125286.35.
 Nothing in this article shall apply to either hospital pharmacies or health system pharmacies that dispense blood clotting products due only to emergency, urgent care, or inpatient encounters, or if an inpatient is discharged with a supply of blood clotting products for home use.