BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 971|
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VETO
Bill No: SB 971
Author: Pavley (D)
Amended: 8/9/10
Vote: 21
SENATE HEALTH COMMITTEE : 9-0, 4/14/10
AYES: Alquist, Strickland, Aanestad, Cedillo, Cox, Leno,
Negrete McLeod, Pavley, Romero
SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 8-0, 4/19/10
AYES: Negrete McLeod, Wyland, Aanestad, Calderon, Correa,
Oropeza, Walters, Yee
NO VOTE RECORDED: Florez
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SENATE FLOOR : 34-0, 6/2/10
AYES: Aanestad, Alquist, Ashburn, Calderon, Cedillo,
Cogdill, Corbett, Correa, Cox, Denham, DeSaulnier,
Ducheny, Dutton, Florez, Hancock, Harman, Huff, Kehoe,
Leno, Lowenthal, Negrete McLeod, Padilla, Pavley, Price,
Romero, Runner, Simitian, Steinberg, Strickland, Walters,
Wolk, Wright, Wyland, Yee
NO VOTE RECORDED: Hollingsworth, Liu, Oropeza, Wiggins,
Vacancy, Vacancy
ASSEMBLY FLOOR : 75-0, 8/16/10 - See last page for vote
SENATE FLOOR : 35-0, 8/25/10
AYES: Aanestad, Alquist, Ashburn, Blakeslee, Calderon,
Cedillo, Cogdill, Corbett, Correa, Denham, DeSaulnier,
Ducheny, Dutton, Emmerson, Florez, Hancock, Huff, Kehoe,
CONTINUED
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Leno, Liu, Lowenthal, Negrete McLeod, Padilla, Pavley,
Price, Romero, Runner, Simitian, Steinberg, Strickland,
Walters, Wolk, Wright, Wyland, Yee
NO VOTE RECORDED: Harman, Hollingsworth, Oropeza, Wiggins,
Vacancy
SUBJECT : Genetic disease services: bleeding disorders:
blood clotting
products
SOURCE : Hemophilia Council of California
DIGEST : This bill establishes requirements governing
entities that provide blood clotting products for home use
in the treatment of hemophilia and other bleeding disorders
and designates the Board of Pharmacy to administer and
enforce these provisions.
Assembly Amendments delete findings regarding
blood-clotting products for home use, clarify language
regarding the disposal of medical waste, recast
definitions, and state that providers must include a health
care service plan and its affiliated providers if the
health care service plane exclusively contracts with a
single medical group.
ANALYSIS :
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.
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.
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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.
5. Creates the Holden-Moscone-Garamendi Genetically
Handicapped Person's Program, which requires the
Director of the Department of Health Care Services to
establish and administer a program for the medical care
of persons with genetically handicapping conditions,
including hemophilia.
This bill:
1. Makes various legislative findings and declarations
relating to establishing standards of service for
entities that deliver blood clotting products for home
use and promoting timely access to a full range of blood
clotting products and high-quality services for home use
for persons with hemophilia and other bleeding
disorders.
2. Establishes various definitions for purposes of this
bill. Defines "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, that is used for the treatment and
prevention of symptoms associated with bleeding
disorders.
3. Defines "provider of blood clotting products" as all of
the following pharmacies that dispense blood clotting
factors for home use:
A. Hospital and health system pharmacies, except
those that dispense blood clotting products due only
to emergency, urgent care, or inpatient encounters,
or discharge an inpatient with a supply of blood
clotting products for home use.
B. Pharmacies affiliated with hemophilia treatment
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centers.
C. Specialty home care pharmacies.
D. Retail pharmacies.
4. Requires each provider of blood clotting products for
home use to 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, as specified.
B. Have access to a provider with sufficient clinical
experience serving people 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. Have access to knowledgeable pharmacy staffing on
call 24 hours a day, to initiate emergency requests
for clotting factors, 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.
D. Have the ability to obtain all brands of blood
clotting products approved by the federal Food and
Drug Administration, as specified, 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, as specified.
G. Provide home nursing services either directly or
through a qualified third party with experience in
treating bleeding disorders, when deemed necessary by
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the treating physician, and coordinate pharmacy
services with the third party provider.
H. Adhere to various shipping and delivery
requirements for blood clotting products and
ancillary infusion equipment upon receiving approved
authorization for nonemergency and emergency
prescriptions, provided manufacturer supply exists,
as specified.
I. Provide patients who have ordered their products
with a designated contact phone number for reporting
problems with a delivery and respond to these calls
within a reasonable time period.
J. Notify patients of federal recalls and withdrawals
of blood clotting products and ancillary infusion
equipment within 24 hours of the provider receiving
notification and participate in the National Patient
Notification System for blood clotting product
recalls.
K. Provide language interpretive services over the
phone or in person, as needed by the patient.
L. Have a detailed plan for meeting the requirements
of this bill in the event of a natural or manmade
disaster or other disruption of normal business
operations.
M. Properly collect, remove, and dispose of medical
waste in accordance with current law governing
medical waste.
N. Provide appropriate and necessary recordkeeping
and documentation as required by state and federal
law and retain copies of the patient's prescriptions.
O. Comply with the privacy and confidentiality
requirements of the Health Insurance Portability and
Accountability Act of 1996.
5. Directs the Board to administer and enforce the
requirements of this bill.
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Background
According to information provided by the bill's sponsor,
hemophilia is a rare, hereditary bleeding disorder
affecting close to 17,000 people in the United States,
approximately 4,000 of whom live in California. Von
Willebrand disease, another bleeding disorder, affects
approximately 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 intravenous (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 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
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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.
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 and Senior Services, in consultation
with the Hemophilia Association.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 8/25/10)
Hemophilia Council of California (source)
California Medical Association
CSL Behring
Federal Hemophilia Treatment Center - Region IX
Grifols
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Herndon Pharmacy
National Hemophilia Foundation
Plasma Protein Therapeutics Association
UCSF Hemophilia Treatment Center
ARGUMENTS IN SUPPORT : According to the author and the
bill's sponsor, the Hemophilia Council of California, 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.
The sponsor cites, 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.
GOVERNOR'S VETO MESSAGE:
"I am returning Senate Bill 971 without my signature. This
bill is unnecessary and attempts to create additional
standards that are already being adequately enforced
through other regulatory and administrative mechanisms.
Since the current standards of practice for blood clotting
products and service are already being met through state
and federal pharmacy laws, voluntary compliance and
existing state contract provisions, it is unclear what
problem this bill seeks to address. For these reasons, I
am unable to sign this bill."
ASSEMBLY FLOOR :
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AYES: Adams, Ammiano, Anderson, Arambula, Beall, Bill
Berryhill, Tom Berryhill, Block, Blumenfield, Bradford,
Brownley, Buchanan, Caballero, Carter, Chesbro, Conway,
Cook, Coto, De La Torre, De Leon, DeVore, Eng, Evans,
Feuer, Fletcher, Fong, Fuentes, Fuller, Furutani, Gaines,
Galgiani, Garrick, Gatto, Gilmore, Hagman, Hall, Harkey,
Hayashi, Hernandez, Hill, Huber, Huffman, Jeffries,
Jones, Knight, Lieu, Logue, Bonnie Lowenthal, Ma,
Mendoza, Miller, Monning, Nava, Nestande, Niello,
Nielsen, Norby, V. Manuel Perez, Portantino, Ruskin,
Salas, Saldana, Silva, Skinner, Smyth, Solorio, Audra
Strickland, Swanson, Torlakson, Torres, Torrico, Tran,
Villines, Yamada, John A. Perez
NO VOTE RECORDED: Bass, Blakeslee, Charles Calderon,
Davis, Vacancy
CTW:mw:nl 10/5/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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