BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 389|
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THIRD READING
Bill No: AB 389
Author: Mitchell (D), et al.
Amended: 3/30/11 in Assembly
Vote: 21
SENATE HEALTH COMMITTEE : 8-0, 6/22/11
AYES: Hernandez, Strickland, Alquist, Anderson, Blakeslee,
De León, DeSaulnier, Wolk
NO VOTE RECORDED: Rubio
SENATE BUSINESS, PROF. & ECON. DEVELOP. COMM. : 8-0, 7/6/11
AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete
McLeod, Vargas, Walters
NO VOTE RECORDED: Wyland
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : 78-0, 4/28/11 - See last page for vote
SUBJECT : Bleeding disorders
SOURCE : Hemophilia council of California
DIGEST : This bill establishes requirements for providers
of blood clotting products for home use to treat hemophilia
and other bleeding disorders.
ANALYSIS : Existing federal law requires the U.S. Food
and Drug Administration (FDA) to regulate the manufacture
of pharmaceuticals derived from blood and blood components,
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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.
Existing state law :
1. Establishes various state programs, administered by the
Department of Health Care Services (DHCS), that provide
medical care for persons with certain genetically based
diseases, such as the Genetically Handicapped Person's
Program (GHPP). GHPP provides medical care for
qualified adults with genetically handicapping
conditions, including hemophilia. Another program, the
California Children's Services Program (CCS), provides
health care for qualified children with various
diseases, including hemophilia or other bleeding
disorders.
2. Requires pharmacies to be licensed by the California
Board of Pharmacy. Requires that California pharmacies
meet specified statutory and regulatory requirements,
including those relating to 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 perform specified procedures,
in accordance with procedures developed by physicians
and health facility administrators, including ordering
or performing routine drug therapy-related patient
assessments, ordering laboratory tests, initiating or
adjusting a patient's drug regimen, and administering
drugs and biologics, such as blood clotting products, by
injection, pursuant to a prescriber's order.
Existing state regulation prohibits pharmacies from
leaving, picking up, accepting, or delivering prescriptions
to or from 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.
This bill :
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1. Establishes the Standards of Service for Providers of
Blood Clotting Products for Home Use Act.
2. Requires that providers of blood clotting products for
home use must:
A. Have sufficient knowledge and understanding of
bleeding disorders and have access to sufficient
clinical expertise in providing services to persons
with bleeding disorders in order to assess the
adequacy of patients' supplies of clotting factor
and to properly store and refrigerate products.
B. Have 24-hour access to knowledgeable pharmacy
staff in order to fill emergency requests for
clotting factors. Also have on-call service
available 24 hours a day to handle emergency
requests for clotting factor, maintain on-call
services all day, every day of the year, screen
calls for emergencies, and respond to all calls
within one hour.
C. Be able to obtain all brands of FDA-approved
clotting products in multiple ranges and sizes and
supply all necessary ancillary infusion equipment
and supplies with each prescription.
D. Store, ship, and deliver products in accordance
with the product's approved package insert and
state and federally mandated standards.
E. Provide home nursing services directly or
through a qualified third party as necessary and
determined by the treating physician.
F. Ship nonemergency prescription clotting products
and ancillary equipment within two business days
upon authorization, provided the manufacturer
supply exists. Deliver clotting products,
medications, equipment and home nursing services
within 12 hours for patients living within 100
miles of a major airport and within 1 day for other
patients, upon authorization and provided the
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manufacturer supply exists. Provide patients with
a contact number for reporting problems with their
delivery, and respond to calls within a reasonable
time period.
G. Alert patients to specified classes of recalls
and withdrawals of blood clotting products and
ancillary equipment, and participate in the
National Patient Notification System for product
recalls.
H. Provide language translation services as needed
by the patient.
I. Have a detailed plan for meeting these
requirements in the event of a natural disaster or
other disruption of normal business operations.
J. Comply with federal and state recordkeeping and
documentation requirements and federal privacy and
confidentiality requirements.
3. Defines "provider of blood clotting products" as all of
the following pharmacies that dispense blood clotting
factors for home use:
A. Hospital pharmacies.
B. Health system pharmacies.
C. Pharmacies affiliated with hemophilia treatment
centers.
D. Specialty home care pharmacies.
E. Retail pharmacies.
4. Defines "provider of blood clotting product" to also
include a health care service plan and its affiliated
providers if the plan exclusively contracts with a
single medical group in a specific geographic area to
provide services to its enrollees.
5. Clarifies that providers of blood clotting products may
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provide home nursing services for persons with bleeding
disorders.
6. Requires the state Board of Pharmacy to enforce this
bill's provisions.
7. Establishes various definitions for purposes of this
bill.
8. 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.
Background
Blood clotting products . According to the National
Hemophilia Council, bleeding disorders may occur
spontaneously or after mild to severe trauma. These
bleeding disorders are treated by replacing the missing
clotting factor in the blood by injecting additional blood
clotting factors into the bloodstream. The timing and
severity of bleeding episodes are unpredictable, even for
patients on regularly scheduled treatment; thus providers
of clotting factor concentrates must be able to effectively
respond to varying frequency and dosing needs.
Clotting factors used to treat hemophilia are FDA-approved,
and may only be used with a prescription. Clotting factors
may be found in whole blood, plasma, and recombinant
factors, which are made in a laboratory and do not use
human blood products. 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. They should generally be stored
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at certain temperatures, and are sensitive to extreme
exposure to light.
Hemophilia treatment centers (HTCs) . HTCs provide
comprehensive diagnostic and treatment services for
individuals with hemophilia and other bleeding disorders,
through interdisciplinary teams that include hematologists,
nurses, social workers, physical therapists, and
orthopedists. HTCs provide patient education on self-care,
and approximately 90 percent of severe hemophilia patients
seen at HTCs self-infuse their clotting factors. HTCs are
federally funded, and provide care 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, as well as standards
established by the National Hemophilia Foundation. HTCs in
California don't directly dispense clotting factor, but
through the 340B federal drug pricing program, they have
contracts with outside pharmacies to distribute/dispense
clotting factor to patients in the home setting.
Specialty care pharmacies . Many blood clotting product
providers in California are considered specialty care
pharmacies. These pharmacies specialize in the provision
of treatments and supplies to individuals with specific
chronic diseases. They generally concentrate their
services on their target patient population, rather than
providing services that meet the needs of the general
public. Specialty care pharmacies must comply with all
statutory and regulatory requirements as traditional
pharmacies, but do not need to meet additional licensing
requirements in order to provide their specialty services.
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.
Medi-Cal contracting requirement . As of July 1, 2010,
providers supplying blood clotting factors to patients in
Medi-Cal, CCS, and the GHPP must sign contracts with the
state indicating that they agree to meet standards similar
to the standards set forth in this bill. According to
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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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 8/15/11)
Hemophilia Council of CA (source)
Baxter Healthcare
California Academy of Family Physicians
California Medical Association
California Pharmacists Association
California Society of Health System Pharmacists
Community Healthcare Services
CSL Behring
DLA Piper
DRG Pharmacy LLC
Federal Hemophilia Treatment Centers Region XI
Grifols, Inc.
Hemophilia Foundation of Northern California
Herndon Pharmacy
Meyer Family Cellars
National Cornerstone Healthcare Services, Inc.
Pfizer
Red Chip Enterprises
Talecris Biotherapeutics
UC Davis Medical Center
Walgreens
ARGUMENTS IN SUPPORT : The Hemophilia Council of
California and the University of California at Davis,
Hemophilia Treatment Center claim that with the production
of highly purified blood clotting factors, people with
hemophilia have the opportunity to lead normal lives, free
of pain and crippling arthritis. For most people with
these bleeding disorders, this necessitates intravenous
injection or infusion of prescription blood clotting
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products several times a week, generally at home. This
bill establishes crucial standards of service for
pharmacies that deliver these blood clotting products to
people with hemophilia and other life-threatening bleeding
disorders in the home setting.
CSL Behring believes it is essential that people with
bleeding disorders receive timely access to the full range
of blood clotting therapies. When patients do not receive
optimal services from providers, there is potential for
painful and sometimes crippling injury to the joints and
organs. CSL Behring asserts that the recommendations and
standards established by the National Hemophilia Foundation
and set forth in this bill are cost- effective and reduce
mortality and bleeding-related hospitalization.
ASSEMBLY FLOOR :
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall, Bill
Berryhill, Block, Blumenfield, Bonilla, Bradford,
Brownley, Buchanan, Butler, Charles Calderon, Campos,
Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson,
Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani,
Galgiani, Garrick, Gatto, Gordon, Grove, Hagman,
Halderman, Hall, Harkey, Hayashi, Roger Hernández, Hill,
Huber, Hueso, Huffman, Jeffries, Jones, Knight, Lara,
Logue, Bonnie Lowenthal, Ma, Mansoor, Mendoza, Miller,
Mitchell, Monning, Morrell, Nestande, Nielsen, Norby,
Olsen, Pan, Perea, V. Manuel Pérez, Portantino, Silva,
Skinner, Smyth, Solorio, Swanson, Torres, Valadao,
Wagner, Wieckowski, Williams, Yamada, John A. Pérez
NO VOTE RECORDED: Gorell, Vacancy
CTW:do 8/16/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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