BILL ANALYSIS
SB 971
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Date of Hearing: August 4, 2010
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
SB 971 (Pavley) - As Amended: June 23, 2010
Policy Committee: Health Vote: 19-0
Business & Professions 11-0
Urgency: No State Mandated Local Program:
No Reimbursable:
SUMMARY
This bill establishes uniform standards, effective July 1, 2011,
related to contracts for the storage and delivery of blood
clotting products for home use for patients with hemophilia and
related disorders that lead to uncontrolled bleeding if left
untreated. Specifically, this bill:
1)Establishes definitions for terms including bleeding disorder,
blood clotting product, and home nursing services.
2)Establishes standards for providers of blood clotting products
for home use, including clinical knowledge, and availability
of diverse FDA-approved blood clotting products.
3)Specifies the requirements in this bill do not apply to
emergency medical situations and do not apply to inpatient
hospital treatment settings.
4)Requires the California Board of Pharmacy to administer and
enforce the requirements established by this bill.
FISCAL EFFECT
1)Minor absorbable workload to the California Board of Pharmacy
to provide oversight related to requirements established by
this bill.
2)Several phrases contained in the legislative intent of this
bill address cost and budgetary issues, including assertions
about cost containment and cost-efficacy. Such terminology
creates concern with regard to confirming the accuracy of such
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statements and the risk of elevating certain diseases or
treatments over others during cycles of major budget
reductions. The author may wish to narrow intent language to
address this concern.
COMMENTS
1)Rationale . This bill is sponsored by the Hemophilia Council of
California to establish standards in state law for the proper
storage and delivery of blood clotting products. This bill
contains many similar provisions to recently implemented
regulations.
Blood clotting products refers to a variety of prescription
treatments approved by the FDA. Safe use of clotting products
requires the use of ancillary supplies and equipment,
including syringes, tourniquets, gauze, and alcohol swabs.
According to the author and sponsor, specialty care pharmacies
typically provide blood factor products and the ancillary
services. These specialized pharmacies have expertise to
handle the treatments and provide related clinical support.
Occasionally, less experienced pharmacies have failed to
provide safe and effective blood clotting-related treatments.
This bill establishes uniform statewide standards to ensure
minimum safety and quality levels are met in the future.
2)Suggested committee amendments narrow the legislative intent
language of the bill to delete phrases such as "extremely cost
effective" and "for the benefit?of cost containment".
3)Blood clotting products are used by patients with hemophilia
and related diseases such as Von Willebrand disease. More than
4,000 Californians have hemophilia and more than 350,000 have
been diagnosed with Von Willebrand disease. These diseases are
inherited, chronic, lifelong, and incurable. They cause
abnormal bleeding. The bleeding occurs because plasma in the
blood has too little of a protein that helps blood clot. Until
recent decades, these bleeding disorders led to uncontrolled
bleeding, orthopedic deformities, and death. More recently
blood factor products have provided effective treatment to
allow individuals with bleeding disorders to lead healthy and
stable lives.
4)Recent trailer bill , AB 1183 (Committee on Budget), Chapter
758, Statutes of 2008 requires pharmacies providing blood
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clotting products in the Medi-Cal Program, the California
Children's Services Program, and the Genetically Handicapped
Persons Program to agree to contracts conforming to standards
similar to those outlined in this bill. The standards include
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.
Analysis Prepared by : Mary Ader / APPR. / (916) 319-2081