BILL ANALYSIS
SB 971
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Date of Hearing: June 22, 2010
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 971 (Pavley) - As Amended: June 15, 2010
SENATE VOTE : 34-0
SUBJECT : Bleeding disorders: blood clotting products.
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 essential, cost effective,
lifesaving, 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
(FDA), 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.
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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 FDA, 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;
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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
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 Board of Pharmacy (Board) to administer and
enforce the requirements of this bill.
EXISTING LAW :
1)Establishes the Board within the Department of Consumer
Affairs to regulate the practice of pharmacy and the licensing
of pharmacies and pharmacists.
2)Specifies certain requirements regarding the proper storage,
handling, dispensing, and disposal of drugs, staff training
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protocols, drug and supply inventory, labeling, and
maintenance of patient confidentiality.
3)Allows pharmacists to perform certain procedures under
specified conditions, including, among other things,
administering drugs and biologics, such as blood clotting
products, by injection, pursuant to a prescriber's order.
4)Prohibits pharmacies from leaving, picking up, accepting, or
delivering prescriptions to any place not licensed as a retail
pharmacy, including a patient's residence or workplace, or a
licensed health facility, with certain exceptions, as
specified.
5)Establishes the Genetically Handicapped Persons Program
(GHPP), administered by the Department of Health Care Services
(DHCS), to provide for the medical care of adults with certain
genetic diseases, including hemophilia.
6)Establishes the FDA to regulate the manufacture of
pharmaceuticals derived from blood and blood components, such
as blood clotting products, including establishing standards
for those products for shipping, storage, and delivery,
inspecting the products, approving them for use by patients,
and recalling products that may be defective or potentially
harmful.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL : 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 notes that the
preferred method of treatment for hemophilia is intravenous
injection or infusion of prescribed blood clotting products,
along with case management and specialized medical care at a
federally designated regional hemophilia treatment center
(HTC). 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
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represent a growing segment of providers in California but
there are currently no formal standards of service in
California to regulate them. The author asserts that this
bill is intended to establish critical life-saving standards
in law for the benefit of people with hemophilia and other
bleeding disorders while ensuring that the current cost
effective model of care is maintained for future generations.
2)BLEEDING DISORDERS . Hemophilia is a rare, hereditary bleeding
disorder affecting approximately 4,000, mostly male,
Californians. It is a chronic, lifelong, incurable yet
treatable disease marked by the absence blood proteins, called
clotting factors, that work to stop bleeding. Lack of
clotting factor causes hemophiliacs to bleed for longer
periods of time and generally results in internal bleeding,
primarily in muscles and joints. Without treatment,
hemophilia can cause pain, severe joint damage, disability,
and early death. Von Willebrand disease is another bleeding
disorder caused by a deficiency or defect of a blood clotting
protein called von Willebrand factor. It is considered less
severe than hemophilia and is estimated to affect 360,000
Californians.
3)BLOOD CLOTTING PRODUCTS . Hemophilia and other bleeding
disorders are treated by replacing the missing clotting factor
in the blood through injections of additional blood clotting
factors into the bloodstream. Clotting factors used to treat
hemophilia are approved by the FDA and can only be used with a
prescription. Clotting factors are found in whole blood,
plasma, and recombinant factors, which are made in a
laboratory and do not involve human blood products. A number
of blood clotting products, made by a variety of
pharmaceutical manufacturers, may be prescribed to temporarily
replace the missing clotting factors in order to prevent or
contain bleeding episodes. Proper administration of blood
clotting products requires the use of ancillary supplies and
equipment, including syringes, tourniquets, gauze, and alcohol
swabs. Blood clotting products are generally expensive, and
require special storage and handling as they are sensitive to
extreme exposure to light.
4)PUBLIC PROGRAMS . As of July 1, 2010, pharmacies providing
blood clotting factors to patients in the Medi-Cal Program,
the California Children's Services Program, and GHPP must sign
contracts with the state indicating that they agree to meet
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standards similar to the standards set forth in this bill.
According to information from DHCS, 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, 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.
5)HTCs . In 1974 Congress authorized the national network of
HTCs to provide access to comprehensive specialized care for
individuals with bleeding disorders. HTCs use
interdisciplinary teams with specialized training that include
hematologists, pediatricians, nurses, social workers, physical
therapists, orthopedists, and dentists, to provide case
management services and coordinate care with primary care
providers and specialists, such as genetic counselors and
obstetrician/gynecologists. About 90% of severe hemophilia
patients seen at HTCs self-infuse their clotting factors and
HTCs specialize in patient education on self-care. HTCs
operate in accordance with goals established by the U.S.
Department of Health and Human Services Maternal and Child
Health Bureau, and the Centers for Disease Control and
Prevention (CDC), as well as standards established by the
National Hemophilia Foundation. There are 11 HTCs throughout
California primarily affiliated with university-based
hospitals, including the Lucile Packard Children's Hospital of
Stanford, and the University of California Medical Centers at
Davis, San Diego, and San Francisco. The CDC reports that the
care provided at HTCs significantly improves the prevention of
complications for persons with bleeding disorders; mortality
rates are 40% lower among patients who use HTCs compared to
those who do not.
6)SPECIALIZED PHARMACIES . Many blood clotting product providers
in the state are specialty care pharmacies. These pharmacies
specialize in providing treatments and supplies to individuals
with particular chronic diseases. Generally, they focus their
services on targeted patient populations, rather than the
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needs of the general public. Specialty care pharmacies are
subject to the same statutory and regulatory requirements as
traditional pharmacies, but they do not need to meet
additional licensing requirements in order to provide their
specialized services. These types of pharmacies usually ship
or deliver blood clotting products to the homes of individuals
with hemophilia and other clotting disorders and, when
necessary, they provide or arrange for nursing services to
patients who need assistance with infusing the blood factor
products.
7)PRIOR LEGISLATION .
a) SB 1594 (Steinberg) of 2008 would have imposed
requirements on providers of blood clotting products for
home use that are used to treat hemophilia and other
bleeding disorders. SB 1594 died on the Senate
Appropriations Committee Suspense File.
b) AB 2408 (Negrete McLeod), Chapter 777, Statutes of 2007,
revises the scope of professional practice for pharmacists
to include authorization for pharmacists to administer
drugs and biologics by injection pursuant to a prescriber's
order.
8)SUPPORT . 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 California Medical Association writes that many
pharmacies and other entities specializing in the delivery of
these products for home use are not licensed by the state or
located at HTCs and this bill will ensure that all providers
of these products are subject to the same quality and service
standards that will benefit consumers. Herndon Pharmacy, a
specialty care pharmacy, states that this bill accomplishes
the goal of making sure that HTCs and specialty care
pharmacies that provide blood clotting factors store it
properly and have sufficient supplies available to patients at
any given time. CSL Behring, a maker of plasma-derived and
recombinant therapies, writes that individuals with blood
disorders need to receive timely access to the full range of
blood clotting therapies and the standards specified in this
bill will help make treatment for these patients
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cost-effective and reduce mortality and bleeding-related
hospitalization. Finally, 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.
9)OPPOSITION . 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 notes that whenever a new FDA approved
pharmaceutical proves to be superior in safety and efficacy to
what is on Kaiser's formulary, the new proven pharmaceutical
is added. 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 due to be included in applicable Medi-Cal contracts.
10)DOUBLE REFERRAL . This bill is double referred. Should it
pass this committee, it will be referred to the Assembly
Committee on Business, Professions and Consumer Protection.
REGISTERED SUPPORT / OPPOSITION :
Support
Hemophilia Council of California (sponsor)
California Medical Association
CSL Behring
Federal Hemophilia Treatment Center - Region IX
Grifols Inc.
Herndon Pharmacy
National Hemophilia Foundation
Plasma Protein Therapeutics Association
Opposition
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Kaiser Permanente
Department of Consumer Affairs
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097