BILL ANALYSIS
SB 971
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Date of Hearing: June 29, 2010
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 971 (Pavley) - As Amended: June 23, 2010
SENATE VOTE : 34-0
SUBJECT : Bleeding disorders: blood clotting products.
SUMMARY : Establishes requirements for entities providing blood
clotting products for home use (providers) to treat hemophilia
and other bleeding disorders; designates the Board of Pharmacy
(Board) to administer and enforce these provisions.
Specifically, this bill :
1)Requires providers 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 and the medical and psychosocial management
thereof, including, but not limited to, home therapy;
b) Have access to a provider with sufficient clinical
experience providing services to persons 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;
d) Have the ability to obtain all brands of blood clotting
products approved by the federal Food and Drug
Administration (FDA) in multiple assay ranges (low, medium,
and high, as applicable) 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.
e) Supply all necessary ancillary infusion equipment and
supplies with each prescription, as needed;
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f) 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 (PI);
g) Provide home nursing services, as determined by the
treating physician, either directly or through a qualified
third party with experience in treating bleeding disorders
and coordinate pharmacy services with the third party when
one is used to provide home nursing services;
h) Ship the prescribed blood clotting products and
ancillary infusion equipment and supplies to the patient
within two business days or less upon receiving approved
authorization for a nonemergency prescription, provided
manufacturer supply exists;
i) Deliver prescribed blood products, ancillary infusion
equipment and supplies, medications, and home nursing
services to the patient within 12 hours 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 upon receiving approved
authorization to dispense a prescription for an emergency
situation, provided manufacturer supply exists;
j) 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;
aa) 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;
bb) Provide patients with notification of Class 1 and Class
2 recalls and withdrawals of blood clotting products and
ancillary infusion equipment within 24 hours of the
provider of blood clotting products for home use receiving
notification and participate in the National Patient
Notification System for blood clotting product recalls;
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cc) Provide language interpretive services over the phone or
in person, as needed by the patient;
dd) 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;
ee) Provide the patient with a sharps container and
instructions as to how to dispose of the medical waste
sharps; however, the provider shall not be liable for any
acts or omissions of the patient in the handling and
disposal of medical waste;
ff) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and
retain copies of the patient's prescriptions; and,
gg) Comply with the privacy and confidentiality requirements
of the Health Insurance Portability and Accountability Act
of 1996.
2)Requires the Board to administer and enforce this bill.
3)Permits providers to provide home nursing services for persons
with bleeding disorders, and requires them to include a health
care service plan and all its affiliated providers, if the
health care service plan exclusively contracts with a single
medical group in a specified geographic area to provide
professional services to its enrollees.
4)Prohibits any provisions of this bill from applying to either
hospital pharmacies or health system pharmacies that dispense
blood clotting products due only to emergency, urgent care, or
inpatient encounters, or if an inpatient is discharged with a
supply of blood clotting products for home use.
5)Defines the following terms:
a) "Assay" means 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" means the
equipment and supplies required to infuse a blood clotting
product into a human vein, including, but not limited to,
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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" means 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" means an intravenously
administered medicine manufactured from human plasma or
recombinant biotechnology techniques, approved for
distribution by the federal FDA, that is used for the
treatment and prevention of symptoms associated with
bleeding disorders. Blood clotting products include, but
are not limited to, Factor VII, Factor VIIa, Factor VIII,
and Factor IX products, von Willebrand Factor products,
bypass products for patients with inhibitors, and activated
prothrombin complex concentrates;
e) "Emergency care" means medical screening, examination,
and evaluation by a physician, or, to the extent permitted
by applicable law, by other appropriate personnel under the
supervision of a physician, to determine if an emergency
medical condition or active labor exists and, if it does,
the care, treatment, and surgery by a physician necessary
to relieve or eliminate the emergency medical condition,
within the capability of the facility;
f) "Hemophilia" means 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;
g) "Hemophilia treatment center" means a facility for the
treatment of bleeding disorders, including, but not limited
to, hemophilia, that receives funding specifically for the
treatment of patients with bleeding disorders from federal
government sources, including, but not limited to, the
federal Centers for Disease Control and Prevention and the
federal Health Resources and Services Administration of the
United States Department of Health and Human Services;
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h) "Home nursing services" means specialized nursing care
provided in the home setting to assist a patient in the
reconstitution and administration of blood clotting
products;
i) "Home use" means infusion or other use of a blood
clotting product in a place other than a state-recognized
hemophilia treatment center or other clinical setting,
including, without limitation, a home or other nonclinical
setting;
j) "Patient" means a person needing a blood clotting
product for home use; and,
aa) "Provider of blood clotting products for home use"
(provider) means all the following pharmacies, except as
specified, that dispense blood clotting factors for home
use:
i) Hospital pharmacies;
ii) Health system pharmacies;
iii) Pharmacies affiliated with hemophilia treatment
centers;
iv) Specialty home care pharmacies; and,
v) Retail pharmacies.
6)Declares legislative intent.
EXISTING LAW :
1)Establishes the Board within the Department of Consumer
Affairs (DCA) 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
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,
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administering drugs and biologics, such as blood clotting
products, by injection, pursuant to a prescriber's order.
4)Establishes the Genetically Handicapped Persons Program
(GHPP), administered by the Department of Health Care
Services, to provide for the medical care of adults with
certain genetic diseases, including hemophilia.
5)Establishes the federal 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 products, approving products for use by patients,
and recalling products that may be defective or potentially
harmful.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office, "The
intent of the bill is to place standards in state law regarding
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 bill
would set standards in place for the delivery of clotting factor
and other related equipment and supplies for home usage.
"In previous years, some pharmacies have mishandled clotting
factor through improper storage and delivery - posing a health
risk to patients. This bill would ensure that pharmacies have
proper safeguards in place to ensure the safety and well-being
of patients."
Background . Hemophilia is a rare, hereditary bleeding disorder
affecting approximately 4,000, mostly male, Californians. It is
a chronic, lifelong, and incurable, but treatable disease marked
by the absence of clotting factors that stop bleeding. Lack of
clotting factor causes hemophiliacs to bleed for longer periods
of time and results in internal bleeding, primarily in muscles
and joints. Without treatment, hemophilia can cause pain,
severe joint damage, disability, and early death.
Hemophilia and other bleeding disorders are treated by replacing
the missing clotting factor in the blood. Clotting factors are
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approved by the FDA and can only be used with a prescription.
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.
Most blood clotting product providers in the state are specialty
care pharmacies. However, all pharmacies are permitted under
their license to supply such products. Specialty care
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 needs of the general public. 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, provide or arrange for nursing services to
patients who need assistance with infusing the blood factor
products. According to the bill's sponsor, there have been
incidences in the past of non-specialty pharmacies failing to
handle clotting factors appropriately.
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 agree to standards similar to
those in this bill. These requirements were adopted two years
ago as part of the State Budget. According to the Board, the
pharmacies affected by this agreement represent approximately
half of those serving California's hemophilia population.
This bill seeks to standardize the pharmacy requirements for
both public and private pay individuals needing clotting
products.
Previous 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. SB 1594 was held in the Senate Appropriations
Committee Suspense File.
Arguments in support . CSL Behring writes, "It is essential that
individuals with bleeding disorders receive timely access to the
full range of blood clotting therapies, including blood clotting
products and ancillary infusion equipment and supplies. When
patients do not receive optimal service from providers, there is
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potential for painful and sometimes crippling injury to the
joints and organs. The recommendations and standards
established by the Medical Science Advisory Council of the
National Hemophilia Foundation and set forth in this legislation
are found to be cost-effective and reduce mortality and
bleeding-related hospitalization.
Arguments in opposition . DCA writes, "[We] appreciate the
intent of this bill. However, DCA believes that an adequate
case as to why existing law is insufficient has not been made.
It is our understanding that, at present, the general level of
service and care received by bleeding disorder patients is high.
Furthermore, the bulk of the provisions of this bill are
already due to be included in applicable Medi-Cal contracts.
Therefore, DCA has not been shown what problem this bill seeks
to rectify."
REGISTERED SUPPORT / OPPOSITION :
Support
Hemophilia Council of California (sponsor)
California Medical Association
CSL Behring
Federal Hemophilia Treatment Centers/Region IX
Grifols Inc.
Herndon Healthcare, Inc.
National Hemophilia Foundation
Plasma Protein Therapeutics Association
Opposition
Department of Consumer Affairs
Analysis Prepared by : Sarah Weaver / B.,P. & C.P. / (916)
319-3301