BILL ANALYSIS
------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 971|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
------------------------------------------------------------
THIRD READING
Bill No: SB 971
Author: Pavley (D)
Amended: 6/1/10
Vote: 21
SENATE HEALTH COMMITTEE : 9-0, 4/14/10
AYES: Alquist, Strickland, Aanestad, Cedillo, Cox, Leno,
Negrete McLeod, Pavley, Romero
SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 8-0, 4/19/10
AYES: Negrete McLeod, Wyland, Aanestad, Calderon, Correa,
Oropeza, Walters, Yee
NO VOTE RECORDED: Florez
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Genetic disease services: bleeding disorders:
blood clotting
products
SOURCE : Hemophilia Council of California
DIGEST : This bill establishes standards for the proper
storage and delivery of blood clotting factor, a prescribed
biologic, and other related equipment and supplies for home
usage by people with hemophilia or other bleeding
disorders.
Senate Floor Amendments of 6/1/10 (1) remove the
requirement for pharmacies to collect all billing
CONTINUED
SB 971
Page
2
information to patients up front and provide patients with
a copy of all billing invoices up front, (2) remove a
requirement that pharmacies maintain adequate stocks of
blood clotting products and ancillary infusion equipment
and supplies, in response to concerns that the term
"adequate" is unclear and difficult to define, (3) clarify
that the standards for blood clotting products only apply
to pharmacies, (4) remove a requirement that pharmacies
respond to all phone calls about blood clotting products
within one hour or less, and instead allows pharmacies to
acknowledge all phone calls within one or less, and (5)
make clarifying changes.
ANALYSIS :
Existing law:
1. Provides for the practice of pharmacy and the licensing
and regulation of pharmacies, and pharmacists by the
Board of Pharmacy (Board) within the Department of
Consumer Affairs.
2. Specifies certain requirements regarding the 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 administer drugs and biologics
pursuant to a prescriber's order.
4. Prohibits pharmacies from leaving, picking up from,
accepting, or delivering prescriptions to 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.
5. Creates the Holden-Moscone-Garamendi Genetically
Handicapped Person's Program, which requires the
Director of the Department of Health Care Services to
establish and administer a program for the medical care
of persons with genetically handicapping conditions,
including hemophilia.
This bill:
CONTINUED
SB 971
Page
3
1. Creates the Standards of Service for Providers of Blood
Clotting Products for Home Use Act (Act).
2. Establishes findings and declarations about bleeding
disorders and treatment for bleeding disorders.
3. Specifies that the purposes of the Act is to establish
standards of service for providers of blood clotting
supplies and promoting access to a full range of
essential blood clotting products and equipment for use
at home by people with hemophilia and other bleeding
disorders.
4. Applies definitions for the purpose of this Act,
specifically:
A. "Assay" as the amount of a particular constituent
of a mixture or of the biological or pharmacological
potency of a drug.
B. "Ancillary infusion equipment and supplies" as the
equipment and supplies required to infuse a blood
clotting product into a human vein, including, but
not limited to, syringes, needles, sterile gauze,
field pads, gloves, alcohol swabs, numbing creams,
tourniquets, medical tape, sharps or equivalent
biohazard waste containers, and cold compression
packs.
C. "Bleeding disorder" as a medical condition
characterized by a deficiency or absence of one or
more essential blood clotting proteins in the human
blood, often called "factors," including all forms of
hemophilia and other bleeding disorders that result
in uncontrollable bleeding or abnormal blood clotting
without treatment.
D. "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
CONTINUED
SB 971
Page
4
disorders.
E. "Patient" as a person needing a blood clotting
product for home use.
F. "Emergency" as a situation in which a prudent
layperson could reasonably believe that the
consumer's condition requires immediate medical
attention.
G. "Hemophilia" as a human bleeding disorder caused
by a hereditary deficiency of the Factors I, II, V,
VIII, IX, XI, XII, or XIII blood clotting protein in
human blood.
H. "Hemophilia treatment center" as a facility for
the treatment of bleeding disorders, including, but
not limited to, hemophilia, that receives funding
from federal government sources.
I. "Home nursing services" as specialized nursing
care provided in the home setting to assist a patient
in the reconstitution and administration of blood
clotting products
J. "Home use" as infusion or other use of a blood
clotting product in a place other than a
state-recognized hemophilia treatment center,
including a home or other non-clinical setting.
K. "Provider of blood clotting products for home use"
as a provider of blood clotting products and
ancillary infusion equipment for home use and
consumer assistance, including home nursing services
for persons with bleeding disorders, for the
management of bleeding disorders.
2. Provides that each provider of blood clotting products
for home use shall 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
CONTINUED
SB 971
Page
5
high-quality service for the consumer and the medical
and psychological management thereof, including, but
not limited to, home therapy.
B. Have sufficient clinical experience serving people
with bleeding disorders and have sufficient
non-clinical understanding of bleeding disorders so
he/she knows when patients have an appropriate supply
of clotting factor on hand and knows about proper
refrigeration of clotting factors.
C. Ensure that customer service staff the
requirements of #A and #B above.
D. Have knowledgeable pharmacy staff on call 24 hours
a day in the event of need to provide emergency
clotting factors.
E. Have the ability to approve all brands of blood
clotting products approved by the FDA in multiple
assay and vial sizes, including products manufactured
from human plasma and those manufactured with
recombinant biotechnology techniques, provided
manufacturer supply exists and payer authorization is
obtained.
F. Supply all necessary ancillary infusion equipment
and supplies with each prescription, as needed.
G. Maintain adequate stocks of blood clotting
products and ancillary infusion equipment and
supplies.
H. Store and ship, or otherwise deliver, all blood
clotting products in conformity with all state and
federally mandated standards, including, but not
limited to, the standards set forth in the product's
approved package insert.
I. When home nursing services are prescribed by the
treating physician, to offer these services either
directly or through a qualified third party with
experience in infusing bleeding disorders and
coordinate pharmacy services with the third party
CONTINUED
SB 971
Page
6
when one is used to provide home nursing services.
J. Upon receiving approved authorization for a
non-emergency prescription, to ship the prescribed
blood clotting products and ancillary infusion
equipment and supplies to the consumer within two
business days for established customers and three
business days for new customers.
K. Upon receiving approved authorization to dispense
a prescription for an emergency situation, to deliver
prescribed blood products, ancillary infusion
equipment and supplies, medications, and home nursing
services to the consumer within 12 hours after
receipt of the prescription for patients living
within 100 miles of a major metropolitan airport, and
within one day for patients living more than 100
miles from a major metropolitan airport.
L. 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.
M. Provide consumers who have ordered their products
a designated contact phone number for reporting
problems with a delivery and respond to these calls
immediately.
N. Provide patients notification of recalls and
withdrawals of blood clotting products and ancillary
infusion equipment within 24 hours and requires
providers to participate in the National Patient
Notification System for blood clotting product
recalls.
O. Provide language translation services, both over
the phone and in person, as needed by the consumer.
P. Have a detailed plan for fulfilling their
requirements in the event of a natural or manmade
disaster or other disruption of normal business
operations.
CONTINUED
SB 971
Page
7
Q. Provide for proper collection, removal, and
disposal of hazardous waste pursuant to state and
federal law, including, but not limited to, sharps
containers for the removal and disposal of medical
waste.
R. Clearly inform a consumer of his/her co-pay,
deductible, and coinsurance payment responsibilities
initially and when changed by the consumer's
insurance, health plan, or other third-party payer.
S. Provide consumers with a copy of all billing
invoices.
T. Provide appropriate and necessary recordkeeping
and documentation as required by state and federal
law and retain copies of the patient's prescriptions.
U. Comply with the privacy and confidentiality
requirements of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA).
3. Requires the Board to enforce and administer the
provisions of the article.
Background
According to information provided by the bill's sponsor,
hemophilia is a rare, hereditary bleeding disorder
affecting close to 17,000 people in the United States,
approximately 4,000 of whom live in California. Von
Willebrand disease, another bleeding disorder, affects
approximately 360,000 Californians. People born with
hemophilia have little or no clotting factor, the protein
needed for normal blood clotting. Until the 1970s, people
with severe hemophilia suffered from uncontrollable
internal bleeding, orthopedic deformities and a shortened
lifespan. Recent inventions and production of highly
purified blood clotting factors have helped give additional
quality of life to those living with bleeding diseases.
Factor products on the market today are usually free from
previous risks like HIV and hepatitis as a result of
contaminated material.
CONTINUED
SB 971
Page
8
Bleeding diseases are not curable but are treatable, often
through intravenous (IV) injection or infusion of
prescription blood clotting products several times per
week. 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, including storage at certain temperatures, and
sensitivity to extreme exposure to light. The Centers for
Disease Control (CDC) recommends timely access to
hemophilia treatment and the products and services related
to that treatment.
Treatment is available to people with hemophilia and others
suffering bleeding disorders at federally funded Hemophilia
Treatment Centers (HTCs) or by prescription at pharmacies
licensed in the state. The CDC reports that patients
treated at HTCs significantly reduce their morbidity and
mortality. There are over 140 HTCs in the nation which
provide both diagnostic and treatment services to people
with hemophilia and other bleeding disorders, combining the
efforts of physicians, nurses, social workers, physical
therapists, orthopedists and dentists to comprehensively
serve patients.
In California, many blood clotting product providers are
specialty care pharmacies. While these pharmacies may
specialize in the provision of treatments and supplies to
individuals with specific chronic diseases, they are not
licensed according to different standards than other
pharmacies. 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.
Various other states including California have attempted to
establish standards for blood clotting products, including
Massachusetts, Missouri, Pennsylvania and New Jersey. New
CONTINUED
SB 971
Page
9
Jersey enacted that state's "Standards of Care in
Hemophilia Homecare Law" that was enacted in 2000. The
primary issue was a requirement by insurers that people
with hemophilia worked with certain home care companies
with which they had contracts. The Hemophilia Association
of New Jersey found that often times, not all home care
companies were familiar with hemophilia care, needs, and
complications. New Jersey now requires all insurance
carriers that provide coverage for the home treatment of
hemophilia to contract with home care providers that comply
with certain minimum standards of care developed by their
Department of Health and Senior Services, in consultation
with the Hemophilia Association.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 5/17/10) (prior version of the bill)
Hemophilia Council of California (source)
California Medical Association
CSL Behring
Federal Hemophilia Treatment Center - Region IX
Grifols
Herndon Pharmacy
National Hemophilia Foundation
Plasma Protein Therapeutics Association
UCSF Hemophilia Treatment Center
OPPOSITION : (Verified 5/17/10) (prior version of the
bill)
California Children's Hospital Association
California Hospital Association
California Pharmacists Association
Kaiser Permanente Medical Program
ARGUMENTS IN SUPPORT : According to the author and the
bill's sponsor, the Hemophilia Council of California, there
are currently no standards of service in state law
governing the proper storage and delivery of blood clotting
products and this bill will protect the health of people
with coagulation disorders who use these products at home.
The sponsor cites, as a need for a state standard, a recent
CONTINUED
SB 971
Page
10
situation in which a northern California pharmacy delivered
clotting factor product to a patient and left it on their
doorstep where the product subsequently spoiled in the
heat. The author and sponsor also note that pharmacies and
other entities specializing in the delivery of blood
clotting products for home use form a growing segment in
California and standards will "benefit people with
hemophilia and other bleeding disorders, as well as
maintain the current cost effective model for care for
future generations." The sponsor also states that
California needs to have equal standards for all companies
distributing clotting factor in order to protect people
with bleeding disorders from companies that may not
properly store or distribute clotting factor.
ARGUMENTS IN OPPOSITION : The California Pharmacists
Association has an "oppose unless amended" position on this
bill because of a number of provisions that are
"problematic for the smaller pharmacies that dispense blood
factor and other medications" to those with bleeding
diseases. "If these requirements were imposed on the
smaller pharmacies serving those with Hemophilia, most
would be forced to discontinue providing these products."
CTW:mw 6/1/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****
CONTINUED