Bill Text: CA SB971 | 2009-2010 | Regular Session | Amended
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Bleeding disorders: blood clotting products.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Vetoed) 2010-09-29 - In Senate. To unfinished business. (Veto) [SB971 Detail]
Download: California-2009-SB971-Amended.html
Bill Title: Bleeding disorders: blood clotting products.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Vetoed) 2010-09-29 - In Senate. To unfinished business. (Veto) [SB971 Detail]
Download: California-2009-SB971-Amended.html
BILL NUMBER: SB 971 AMENDED
BILL TEXT
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.
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) "Assay" means the amount of a particular constituent of a
mixture or of the biological or pharmacological potency of a drug.
(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.
(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.
(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.
(5) "Consumer" means a person needing a blood clotting product for
home use.
(6)
(5) "Emergency" means a situation in which a prudent
layperson could reasonably believe that the consumer's
patient's condition requires immediate medical
attention.
(7)
(6) "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.
(8)
(7) "Hemophilia treatment center" means a facility for
the treatment of bleeding disorders, including, but not limited to,
hemophilia, that receives funding 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.
(9)
(8) "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.
(10)
(9) "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 other nonclinical setting.
(10) "Patient" means a person needing a blood clotting product 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 patient 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
patient 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) 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) Supply all necessary ancillary infusion equipment and supplies
with each prescription, as needed.
(g) Maintain adequate stocks of blood clotting products and
ancillary infusion equipment and supplies.
(h)
(g) 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).
(i)
(h) 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.
(j)
(i) 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 consumer
patient within two business days or less for established
and new consumers patients .
(k)
(j) 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 consumer 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.
(l)
(k) Maintain 24-hour on call service seven days a week
for every day of the year, adequately screen phone calls for
emergencies, and respond to acknowledge
all phone calls within one hour or less.
(m) Provide consumers
(l) 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.
(n)
(m) 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.
(o) Provide language translation services over the phone or in
person, as needed by the consumer.
(n) Provide language interpretive services over the phone or in
person, as needed by the patient.
(p)
(o) 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.
(q)
(p) 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.
(r) 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.
(s) Provide consumers with a copy of all billing invoices.
(t)
(q) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and retain copies
of the patient's prescriptions.
(u)
(r) 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.
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