BILL ANALYSIS �
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 389
A
AUTHOR: Mitchell
B
AMENDED: March 30, 2011
HEARING DATE: June 22, 2011
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REFERRAL: Business, Professions and Economic
Development 8
CONSULTANT:
9
Orr
SUBJECT
Bleeding disorders
SUMMARY
Establishes requirements for providers of blood clotting
products for home use to treat hemophilia and other
bleeding disorders.
CHANGES TO EXISTING LAW
Existing federal law:
Requires the U.S. Food and Drug Administration (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.
Existing state law:
Establishes various state programs, administered by the
Department of Health Care Services (DHCS), that provide
Continued---
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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.
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.
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:
Establishes the Standards of Service for Providers of Blood
Clotting Products for Home Use Act. Requires that providers
of blood clotting products for home use must:
1) 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.
2) 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
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factor, maintain on-call services all day, every day
of the year, screen calls for emergencies, and respond
to all calls within one hour.
3) 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.
4) Store, ship, and deliver products in accordance
with the product's approved package insert and state
and federally mandated standards.
5) Provide home nursing services directly or through a
qualified third party as necessary and determined by
the treating physician.
6) 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 manufacturer supply
exists. Provide patients with a contact number for
reporting problems with their delivery, and respond to
calls within a reasonable time period.
7) 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.
8) Provide language translation services as needed by
the patient.
9) Have a detailed plan for meeting these requirements
in the event of a natural disaster or other disruption
of normal business operations.
10) Comply with federal and state recordkeeping and
documentation requirements and federal privacy and
confidentiality requirements.
Defines "provider of blood clotting products" as all of the
following pharmacies that dispense blood clotting factors
for home use:
1) Hospital pharmacies;
2) Health system pharmacies;
3) Pharmacies affiliated with hemophilia treatment
centers;
4) Specialty home care pharmacies; and
5) Retail pharmacies.
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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.
Clarifies that providers of blood clotting products may
provide home nursing services for persons with bleeding
disorders.
Requires the state Board of Pharmacy to enforce this bill's
provisions.
Establishes various definitions for purposes of this bill.
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.
FISCAL IMPACT
The Assembly Appropriations Committee analysis estimates
minor absorbable costs to the California Board of Pharmacy
to provide oversight related to the requirements
established by this bill.
BACKGROUND AND DISCUSSION
The author aims to establish standards of service for
providers that deliver blood clotting products and related
equipment, supplies, and services for home use. The author
contends this bill will promote access to a full range of
essential, cost-effective, life-saving blood clotting
products and related equipment and supplies for home use
for people who have hemophilia, von Willebrand disease, and
other bleeding disorders.
Hemophilia and other bleeding disorders
Hemophilia is a genetically inherited bleeding disorder
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that affects approximately 4,000 Californians, primarily
males. Those with hemophilia are missing or have
dysfunctional proteins in their blood, called clotting
factors, which work to stop bleeding. The lack of clotting
factor causes hemophiliacs to bleed for longer periods of
time, and generally results in internal bleeding, primarily
into muscles and joints. Without treatment, hemophilia can
cause pain, severe joint damage, disability, and early
death.
Bleeding disorders include von Willebrand disease, a blood
clotting disorder similar to hemophilia that is caused by a
deficiency or defect of a blood clotting protein called von
Willebrand factor which helps blood platelets to clot and
to seal off tears in injured blood vessels. Both men and
women are affected by von Willebrand disease, which is
generally the least severe of the clotting disorders.
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
at certain temperatures, and are sensitive to extreme
exposure to light.
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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 (CDC),
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 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,
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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.
Prior legislation
SB 971 (Pavley) of the 2009-2010 Session was substantially
similar to AB 389. AB 971 was vetoed by Governor
Schwarzenegger with the message: "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."
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.
Failed passage in Senate Appropriations Committee.
AB 2408 (Negrete-McLeod), Chapter 777, Statutes of 2007,
defines 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.
Arguments in support
The Hemophilia Council of California and the UC 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
products several times a week, generally at home. AB 389
would establish 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
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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 AB 389 are cost- effective and reduce
mortality and bleeding-related hospitalization.
PRIOR ACTIONS
Assembly Business, Professions and Consumer Protection: 9-
0
Assembly Health: 15- 3
Assembly Appropriations: 12- 3
Assembly Floor: 78- 0
POSITIONS
Support: Baxter Healthcare
California Medical Association
California Pharmacists Association
Community Healthcare Services
CSL Behring
Federal Hemophilia Treatment Centers, Region IX
Grifols Inc.
Hemophilia Council of California
Hemophilia Foundation of Northern California
Herndon Pharmacy
Hueneme Family Pharmacy
Meyer Family Cellars
National Cornerstone Healthcare Services Inc.
Pfizer Inc.
Plasma Protein Therapeutics Association
Talecris Biotherapeutics
UCD Hemophilia Treatment Center
Walgreens
Two individuals
Oppose: None received.
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