BILL NUMBER: SB 971 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JUNE 15, 2010
AMENDED IN SENATE MAY 28, 2010
AMENDED IN SENATE MAY 12, 2010
AMENDED IN SENATE MAY 3, 2010
AMENDED IN SENATE APRIL 21, 2010
AMENDED IN SENATE APRIL 7, 2010
INTRODUCED BY Senator Pavley
FEBRUARY 8, 2010
An act to add Article 5 (commencing with Section 125286.1) to
Chapter 2 of Part 5 of Division 106 of the Health and Safety Code,
relating to genetic disease services.
LEGISLATIVE COUNSEL'S DIGEST
SB 971, as amended, Pavley. Bleeding disorders: blood clotting
products.
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.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Article 5 (commencing with Section 125286.1) 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
125286.1. This article shall be known, and may be cited, as the
Standards of Service for Providers of Blood Clotting Products for
Home Use Act.
125286.2. 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 have provided people with hemophilia
and other bleeding disorders with 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. All
of these entities are licensed by the state or are located at
federally designated regional hemophilia treatment centers, or both.
(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,
and is extremely cost effective, 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
Medi-Cal the Medi-Cal program . Access to
quality blood clotting products for home use and related equipment,
supplies, and services for people with hemophilia or other bleeding
disorders promotes cost containment in each of these publicly funded
programs as well as in the health insurance and health care
industries more generally.
(h) For the benefit of persons with hemophilia or other bleeding
disorders, as well as for cost containment in health care, 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.
125286.3. (a) Unless the
context otherwise requires, the following definitions shall apply for
purposes of this article:
(1)
(a) "Assay" means the amount of a particular constituent
of a mixture or of the biological or pharmacological potency of a
drug.
(2)
(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.
(3)
(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
result in uncontrollable bleeding or abnormal blood clotting without
treatment.
(4)
(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.
(5) "Emergency" means a situation in which a prudent layperson
could reasonably believe that the patient's condition requires
immediate medical attention.
(e) "Emergency" means care as defined in Section 1317.1.
(6)
(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.
(7)
(g) "Hemophilia treatment center" means a facility for
the treatment of bleeding disorders, including, but not limited to,
hemophilia, that receives funding specifica lly 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.
(8)
(h) "Home nursing services" means specialized nursing
care provided in the home setting to assist a patient in the
reconstitution and administration of blood clotting products.
(9)
(i) "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.
(10)
(j) "Patient" means a person needing a blood clotting
product for home use.
(b) (1) For purposes of this article, a "provider
(k) (1) "Provider
of blood clotting products for home use" shall be a
provider of blood clotting products and ancillary infusion equipment
for home use and patient assistance for the management of bleeding
disorders and may include, but is not limited to, any of the
following: means all the following pharmacies, except
as described in Section 125286.6, 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 may also provide
home nursing services for persons with bleeding disorders.
(3) 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.
125286.4. 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
and a sufficient nonclinical understanding of 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) Ensure that its customer service staff meets the requirements
of subdivisions (a) and (b).
(d) Have
(c) Have access to knowledgeable
pharmacy staffing on call 24 hours a day, to initiate emergency
requests for clotting factors.
(e)
(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.
(f)
(e) Supply all necessary ancillary infusion equipment
and supplies with each prescription, as needed.
(g)
(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).
(h)
(g) When home nursing services are prescribed
necessary, as determined by the treating
physician, provide these services either directly or through a
qualified third party with experience in infusing
treating bleeding disorders and coordinate pharmacy
services with the third party when one is used to provide home
nursing services.
(i)
(h) 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.
(j)
(i) 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, 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.
(k)
(j) Maintain 24-hour on call service seven days a week
for every day of the year, adequately screen phone calls for
emergencies, and acknowledge all phone calls within one hour or less.
(l)
(k) Provide patients who have ordered their products
with a designated contact phone number for reporting problems with a
delivery and respond to these calls immediately
within a reasonable time period .
(m)
(l) 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.
(n)
(m) Provide language interpretive services over the
phone or in person, as needed by the patient.
(o)
(n) 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.
(p)
(o) Provide for proper collection, removal, and
disposal of hazardous waste pursuant to state and federal
law, including, but not limited to, sharps containers for the removal
and disposal of medical waste. medical waste pursuant
to the Medical Waste Management Act (Part 14 (commencing with
Section 117600) of Division 104).
(q)
(p) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and retain copies
of the patient's prescriptions.
(r)
(q) Comply with the privacy and confidentiality
requirements of the Health Insurance Portability and Accountability
Act of 1996 (HIPAA).
125286.5. The California State Board of Pharmacy shall administer
and enforce this article.
125286.6. 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.