BILL NUMBER: SB 971 AMENDED
BILL TEXT
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, 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 , except as provided .
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.
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:
(a)
(1) "Assay" means the amount of a particular
constituent of a mixture or of the biological or pharmacological
potency of a drug.
(b)
(2) "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)
(3) "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.
(d)
(4) "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)
(5) "Consumer" means a person needing a blood clotting
product for home use.
(f)
(6) "Emergency" means a situation in which a prudent
layperson could reasonably believe that the consumer's condition
requires immediate medical attention.
(g)
(7) "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.
(h)
(8) "Hemophilia treatment center" means a facility for
the treatment of bleeding disorders, including, but not limited to,
hemophilia, that receives funding from the 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.
(i)
(9) "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.
(j)
(10) "Home use" means infusion or other use of a blood
clotting product in a place other than a state-recognized hemophilia
treatment center. Places where home use occurs include, without
limitation, a home or physician physician's
office.
(k) "Provider of blood clotting products for home use" means a
seller and provider of blood clotting products, ancillary infusion
equipment, home nursing services, and patient assistance for the
management of bleeding disorders for home use.
(b) (1) For purposes of this article, a "provider of blood
clotting products for home use" shall be a provider of blood clotting
products and ancillary infusion equipment for home use and consumer
assistance for the management of bleeding disorders and may include,
but is not limited to, any of the following:
(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.
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
consumer and the medical and psychosocial management thereof,
including, but not limited to, home therapy.
(b) Have 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 refrigeration of clotting factors.
(c) Ensure that its customer service staff meets the requirements
of subdivisions (a) and (b).
(d) Have knowledgeable pharmacy staffing on call 24 hours a day,
to initiate emergency requests for clotting factors.
(e) Supply blood clotting products and home nursing services, as
prescribed by the consumer's treating physician, and, pursuant to
Section 4073 of the Business and Professions Code, not make any
substitutions of blood clotting products or assay amounts.
(f) The prescribing physician shall indicate which specific blood
clotting product is intended whenever a prescription is written.
(g) Supply 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 approved.
(h) Supply all necessary ancillary infusion equipment and supplies
with each prescription, as needed.
(i) Maintain adequate stocks of blood clotting products and
ancillary infusion equipment and supplies.
(j) 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).
(k) When home nursing services are prescribed by the treating
physician, provide 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.
(l) Upon receiving approved authorization for a nonemergency
prescription, ship the prescribed blood clotting products and
ancillary infusion equipment and supplies to the consumer within two
business days or less for established and new consumers.
(m) Upon receiving approved authorization to dispense a
prescription for an emergency situation, deliver prescribed blood
products, ancillary infusion equipment and supplies, medications, and
home nursing services to the consumer 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.
(n) Maintain 24-hour oncall on call
service seven days a week for every day of the year, adequately
screen phone calls for emergencies, and respond to all phone calls
within one hour or less.
(o) Provide consumers who have ordered their products with a
designated contact phone number for reporting problems with a
delivery and respond to these calls immediately.
(p) Provide patients with notification of recalls and withdrawals
of blood clotting products and ancillary infusion equipment within 24
hours and participate in the National Patient Notification System
for blood clotting product recalls.
(q) Provide language translation services, both over the phone and
in person, as needed by the consumer.
(r) 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.
(s) 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.
(t) Inform a consumer of his or her copay, deductible, and
coinsurance payment responsibilities initially and when changed by
the consumer's insurance, health plan, or other third-party payer.
(u) Provide consumers with a copy of all billing invoices.
(v) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and retain copies
of the patient's prescriptions.
(w) Comply with the privacy and confidentiality requirements of
the Health Insurance Portability and Accountability Act of 1996
(HIPAA).
125286.5. The (a)
Except as provided in subdivision (b), the California State
Board of Pharmacy shall administer and enforce this article.
(b) The California State Board of Pharmacy shall not administer
and enforce subdivision (f) of Section 125286.4.