BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 971
S
AUTHOR: Pavley
B
AMENDED: April 7, 2010
HEARING DATE: April 14, 2010
9
REFERRAL Business, Professions and Economic
Development 7
CONSULTANT:
1
Orr/
SUBJECT
Bleeding disorders: blood clotting products
SUMMARY
Establishes standards of service and storage for entities
that deliver blood clotting products and related equipment
and supplies for home usage to people with hemophilia and
other bleeding disorders. Requires the Board of Pharmacy
to administer and enforce these standards.
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
medical care for persons with certain genetically based
diseases, such as the Genetically Handicapped Person's
Continued---
STAFF ANALYSIS OF SENATE BILL 971 (Pavley) Page 2
Program (GHPP). GHPP provides medical care for qualified
adults with genetically handicapping conditions, including
hemophilia. Another such 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. California pharmacies must 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. Existing law 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. Institutes the
following requirements for providers of blood clotting
products for home use:
1. Have sufficient knowledge and understanding of
bleeding disorders, have sufficient clinical
expertise, and ensure the same of customer service
staff.
2. Have an on-call pharmacist or staff 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. Provide
customers with a contact number for reporting
problems with their delivery, and respond to
STAFF ANALYSIS OF SENATE BILL 971 (Pavley) Page 3
problems immediately.
3. Maintain adequate stocks of clotting products
and ancillary infusion equipment, such as syringes
and tourniquets, and must supply all brands of
approved clotting products in multiple sizes and
amounts, provided manufacturer supply exists and
payer authorization is approved. Providers are
excluded from making substitutions of clotting
products or amounts.
4. Store, ship, and deliver products in accordance
with the product's approved package insert and state
and federally mandated standards, and ensure
nonemergency prescriptions are sent within two
business days of the approved authorization for the
request. Ensure that emergency prescriptions are
delivered to patients within 12 hours if the patient
lives within 100 miles of a major metropolitan
airport, and within one day for patients living
outside that radius.
5. Ensure the qualifications of the prescribed
home nursing services rendered or arranged by the
provider.
6. Alert patients to recalls and withdrawals of
blood clotting products and ancillary equipment, and
participate in the National Patient Notification
System for product recalls.
7. Provide language translation services as needed
by the customer.
8. Have a detailed plan for meeting these
requirements in the event of a natural disaster or
other disruption of normal business operations.
9. Provide for collection, removal and disposal of
hazardous waste.
10. Inform customers of their payment
responsibilities, including copays, deductibles and
coinsurance payments, and provide customers with
copies of billing invoices, and retain copies of
their prescriptions.
11. Comply with federal and state recordkeeping and
documentation requirements, and federal privacy and
confidentiality requirements.
Defines provider of blood clotting product for home use as
a seller or provider of blood clotting products, ancillary
infusion equipment, home nursing services and patient
assistance for the management of bleeding disorders for
STAFF ANALYSIS OF SENATE BILL 971 (Pavley) Page 4
home use. This would include specialty homecare care
pharmacies and hemophilia treatment centers that contract
with outside pharmacies. This also includes health system
pharmacies, hospital pharmacies, and retail pharmacies.
Requires prescribing physicians to name specific blood
clotting products when issuing prescriptions.
Requires the state Board of Pharmacy to enforce these
provisions.
Establishes various other definitions in the context of the
bill, and makes findings and declarations regarding
hemophilia and other bleeding disorders. Establishes that
the purpose of the article is to establish standards of
service for entities that deliver blood clotting products
and related equipment, supplies and services for home use,
and promote access to equipment, supplies and services for
home use for persons with hemophilia and other bleeding
disorders.
FISCAL IMPACT
This bill has not been analyzed by a fiscal committee.
BACKGROUND AND DISCUSSION
According to the author, there are currently no standards
in state law governing the proper storage and delivery of
blood clotting products and clotting factor, a prescribed
biologic that is infused several times per week by people
with hemophilia and other bleeding disorders. The intent of
this bill is to place standards in state law for the proper
storage and delivery of blood clotting factor and other
related equipment and supplies for home usage. The author
believes it is critical to place life-saving standards in
law for the benefit of people with hemophilia and other
bleeding disorders, as well as to maintain the current
cost-effective model of care for future generations.
Hemophilia and other bleeding disorders
Hemophilia is a genetically inherited bleeding disorder
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
STAFF ANALYSIS OF SENATE BILL 971 (Pavley) Page 5
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.
Hemophilia treatment centers (HTCs)
HTCs provide comprehensive diagnostic and treatment
services for individuals with hemophilia and other bleeding
STAFF ANALYSIS OF SENATE BILL 971 (Pavley) Page 6
disorders, through interdisciplinary teams that include
hematologists, nurses, social workers, physical therapists,
and orthopedists. HTCs provide case management services,
and often coordinate care with primary care providers and
specialists such as dentists, genetic counselors, and
obstetrician/gynecologists. 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. In California, HTCs are primarily based at
university-based tertiary care hospitals, including the
Lucile Packard Children's Hospital of Stanford, University
of California (UC) Davis Children's Hospital, and the
Schools of Medicine at UC San Francisco and UC San Diego.
HTCs in California don't directly dispense clotting factor,
but through the 340 B federal pricing program, they have
contracts w/ 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 noted in a March 2010 Provider Bulletin, the Department
STAFF ANALYSIS OF SENATE BILL 971 (Pavley) Page 7
of Health Care Services (DHCS) has received statutory
authority to begin contracting with outpatient providers of
specialized drugs, including blood factors, in order to
meet the unique specialized care needs of the Medi-Cal
population who utilize specialty drugs. Effective July 1,
2010, DHCS will contract with "any specialty pharmacy that
will sign a contract to meet a list of performance
obligations. These include, but are not limited to,
delivery time requirements, providing patient education and
submitting quarterly and yearly reports to DHCS. Providers
who do not sign an agreement to become a provider under
these provisions will no longer be allowed to provide the
specialized drug to Medi-Cal, California Children's
Services (CCS) or Genetically Handicapped Persons Program
(GHPP) recipients."
Prior legislation
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 of the Statutes of
2007, defined 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 Plasma Protein Therapeutics Association represents
manufacturers of plasma-derived and recombinant biological
therapies, collectively known as plasma protein therapies.
They believe this bill will ensure that residents of
California affected by bleeding disorders have access to
medically appropriate care. Delayed access to clotting
factor can cause painful and crippling injury to the joints
and organs, which can lead to increased costs for
hospitals, skilled nursing and other specialty services.
Grifols, Inc, a producer of biologic therapies used to
treat bleeding disorders, claims that each product is a
distinct, sole-source product and none have generic
equivalents. They write in support of the bill, citing the
importance of preserving access to all of the life-saving
therapies available because patients respond differently to
different brands of therapy.
STAFF ANALYSIS OF SENATE BILL 971 (Pavley) Page 8
Arguments in opposition
The California Society of Health-System Pharmacists
recognizes the value of providing the proper medications in
a timely manner to individuals with hemophilia. However,
they believe this bill contains several specific provisions
that have serious consequences for pharmacists, and creates
barriers to providing quality and timely care in an
affordable manner. They believe many of the provisions of
the bill are impossible to implement because many of the
hemophilia drugs require prior approval from the health
insurer of the patient. The requirement in the bill for
providers to supply all brands of clotting factors approved
by the FDA in multiple assays and vial sizes they feel
creates undue financial burden on pharmacies and provider
organizations if they are required to have all of these
drugs in stock.
COMMENTS
1. Definition of provider. The current definition of
provider indicates that in order to be considered a
provider of blood clotting products, entities must also
provide "ancillary infusion equipment, home nursing
services, and patient assistance for the management of
bleeding disorders for home use." Not all entities
currently providing blood clotting products fulfill each
of these requirements, particularly the requirement to
provide home nursing services. A suggested amendment
would be to delete Page 5, lines 6-9 and insert the
following: "Provider of blood clotting products for home
use" includes but is not limited to any hospital
pharmacies, health system pharmacies, pharmacies
affiliated with hemophilia treatment centers, specialty
home care pharmacies, and retail pharmacies that provide
blood clotting products and ancillary infusion equipment
for home use, and patient assistance for the management
of bleeding disorders. These providers may also provide
home nursing services for persons with bleeding
disorders.
2. Clarifying amendments. There are ambiguities in some
of the bill language. The author may wish to clarify what
is meant by "sufficient knowledge and understanding of
bleeding disorders," and "sufficient clinical expertise."
STAFF ANALYSIS OF SENATE BILL 971 (Pavley) Page 9
3. Technical amendment. The requirement for physicians
to specify the type of clotting product to use may not be
enforceable by the Board of Pharmacy, because the Board
does not have jurisdiction over prescribing physicians.
Suggested amendment: Page 7, line 23, after "article"
insert "with the exception of subsection (f) of section
125286.4."
POSITIONS
Support: Hemophilia Council of California (sponsor)
California Medical Association
CSL Behring
Grifols, Inc.
Herndon 1 Pharmacy
Plasma Protein Therapeutics Association
Oppose: California Pharmacists Association
California Society of Health-System Pharmacists
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