BILL ANALYSIS
SB 971
Page 1
SENATE THIRD READING
SB 971 (Pavley)
As Amended August 9, 2010
Majority vote
SENATE VOTE :34-0
HEALTH 19-0 BUSINESS & PROFESSIONS 11-0
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|Ayes:|Monning, Fletcher, |Ayes:|Hayashi, Conway, Eng, |
| |Ammiano, Carter, Conway, | |Hernandez, Hill, Ma, |
| |De La Torre, De Leon, | |Nava, Niello, Ruskin, |
| |Eng, Gaines, Hayashi, | |Smyth, Nestande |
| |Hernandez, Jones, Bonnie | | |
| |Lowenthal, Nava, | | |
| |V. Manuel Perez, Salas, | | |
| |Smyth, Audra Strickland, | | |
| |Gilmore | | |
| | | | |
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APPROPRIATIONS 17-0
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|Ayes:|Fuentes, Conway, |
| |Bradford, |
| |Charles Calderon, Coto, |
| |Davis, |
| |De Leon, Gatto, Hall, |
| |Harkey, Miller, Nielsen, |
| |Norby, Skinner, Solorio, |
| |Torlakson, Torrico |
| | |
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SUMMARY : 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.
Specifically, 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
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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 centers;
c) Specialty home care pharmacies; and,
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
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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 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;
aa) Provide language interpretive services over the phone or
in person, as needed by the patient;
bb) Have a detailed plan for meeting the requirements of
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this bill in the event of a natural or manmade disaster or
other disruption of normal business operations;
cc) Properly collect, remove, and dispose of medical waste
in accordance with current law governing medical waste;
dd) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and
retain copies of the patient's prescriptions; and,
ee) Comply with the privacy and confidentiality requirements
of the Health Insurance Portability and Accountability Act
of 1996.
5)Directs the California Board of Pharmacy (Board) to administer
and enforce the requirements of this bill.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, minor absorbable workload to the Board to provide
oversight related to requirements established by this bill
COMMENTS : According to the author, this bill will impose
statewide standards for the proper storage and delivery of blood
clotting factor, a prescribed biologic that is infused several
times per week by people with hemophilia and other bleeding
disorders. The author states that pharmacies and other entities
specializing in the delivery of blood clotting products and
related equipment, supplies, and services for home use represent
a growing segment of providers in California but there are
currently no formal standards of service in California to
regulate them.
As of July 1, 2010, pharmacies providing blood clotting factors
to patients in the Medi-Cal Program, the California Children's
Services Program, and the Genetically Handicapped Persons
Program must sign contracts with the state indicating that they
agree to meet standards similar to the standards set forth in
this bill. According to information from the Department of
Health Care Services, these specialty contracts for blood factor
products require participating providers to meet various
performance obligations with regard to pharmacy provider staff
knowledge; storage, handling, and delivery of clotting factor
concentrates and ancillary supplies; processing of prescription
orders; hours of operation and access to staff; and,
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recordkeeping, billing, and product recalls. The author
contends that this bill will ensure that the standards in these
contracts are codified in statute to ensure that pharmacies have
proper safeguards in place to provide for the safety and
well-being of publicly- and privately-insured patients in
California who have hemophilia or other bleeding disorders.
Providers, manufacturers of blood clotting products, and patient
advocacy groups support this bill because it would establish
crucial standards of care for health care entities that deliver
blood factor products to people with hemophilia and other
life-threatening blood disorders in the home setting. The
sponsor of this bill, the Hemophilia Council of California
points out that the state has a long history of ensuring that
patients have access to care delivered by medical professionals
with vast experience treating bleeding disorders and this bill
will ensure that patients get the same high quality care and
service from pharmacy providers.
Kaiser Permanente opposes this bill because it would set a
precedent to make all products available for all chronic care
patients, such as diabetics and asthmatics, for example. Kaiser
adds that its physicians have the ability, independent of health
plan approval, to prescribe off the formulary if they feel it is
in the best interest of the patient. The Department of Consumer
Affairs also objects to this bill, arguing that it is unclear
what problem this bill seeks to remedy given that it is the
Department's understanding that, at present, the general level
of service and care received by bleeding disorder patients is
high; and, furthermore, the bulk of the provisions of this bill
are already included in applicable Medi-Cal contracts.
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097
FN: 0005901