BILL ANALYSIS �
AB 389
Page 1
Date of Hearing: April 5, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 389 (Mitchell) - As Amended: March 30, 2011
SUBJECT : Bleeding disorders.
SUMMARY : Prescribes requirements governing entities that
provide blood clotting products for home use in the treatment of
hemophilia and other bleeding disorders and charges the Board of
Pharmacy (Board) with administering and enforcing these
provisions. Specifically, this bill :
1)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.
2)Establishes various definitions for purposes of this bill.
Defines "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 disorders.
3)Defines "provider of blood clotting products" as all of the
following pharmacies that dispense blood clotting factors for
home use:
a) Hospital and health system pharmacies, except those that
dispense blood clotting products due only to emergency,
urgent care, or inpatient encounters, or discharge an
inpatient with a supply of blood clotting products for home
use;
b) Pharmacies affiliated with hemophilia treatment centers;
c) Specialty home care pharmacies; and,
d) Retail pharmacies.
4)Clarifies that providers in 3) above may provide home nursing
AB 389
Page 2
services for persons with bleeding disorders.
5)Requires the providers in 3) above to include a health care
service plan and all its affiliated providers if the plan
exclusively contracts with a single medical group in a
specified geographic area to provide professional services to
its enrollees.
6)Requires each provider 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, as specified;
b) Have access to a provider with sufficient clinical
experience serving people 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, 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;
d) Have the ability to obtain all brands of blood clotting
products approved by the FDA, as specified, provided
manufacturer supply exists and payer authorization is
obtained;
e) Supply all necessary ancillary infusion equipment and
supplies with each prescription, as needed;
f) Store and ship, or otherwise deliver, all blood clotting
products in conformity with all state and federally
mandated standards, as specified;
g) Provide home nursing services either directly or through
a qualified third party with experience in treating
bleeding disorders, when deemed necessary by the treating
physician, and coordinate pharmacy services with the third
party provider;
AB 389
Page 3
h) Adhere to various shipping and delivery requirements for
blood clotting products and ancillary infusion equipment
upon receiving approved authorization for nonemergency and
emergency prescriptions, provided manufacturer supply
exists, as specified;
i) 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;
j) Notify patients of federal recalls and withdrawals of
blood clotting products and ancillary infusion equipment
within 24 hours of the provider receiving notification and
participate in the National Patient Notification System for
blood clotting product recalls;
aa) Provide language interpretive services over the phone or
in person, as needed by the patient;
bb) 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;
cc) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and
retain copies of the patient's prescriptions; and,
dd) Comply with the privacy and confidentiality requirements
of the Health Insurance Portability and Accountability Act
of 1996.
7)Directs the Board to administer and enforce the requirements
of this bill.
EXISTING LAW :
1)Establishes the Board within the Department of Consumer
Affairs 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
AB 389
Page 4
maintenance of patient confidentiality.
3)Allows pharmacists to perform certain procedures under
specified conditions, including, among other things,
administering drugs and biologics, such as blood clotting
products, by injection, pursuant to a prescriber's order.
4)Prohibits pharmacies from leaving, picking up, accepting, or
delivering prescriptions to any place not licensed as a retail
pharmacy, including a patient's residence or workplace, or a
licensed health facility, with certain exceptions, as
specified.
5)Establishes the Genetically Handicapped Persons Program
(GHPP), administered by the Department of Health Care Services
(DHCS), to provide for the medical care of adults with certain
genetic diseases, including hemophilia.
6)Establishes the 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.
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, people with
hemophilia, von Willebrand disease, and other bleeding
disorders often need to receive intravenous injection or
infusion of lifesaving prescription blood clotting factor
products several times a week. Most patients use these
products at home. The author notes that, currently,
pharmacies that provide clotting factor to patients on state
programs, such as Medi-Cal and GHPP, must comply with
standards that are included in written contracts with the
State. The author points out that these standards are not
established for pharmacy providers with patients on private
insurance, and, as a result, these patients have endured some
difficulties in receiving their products. This bill will
ensure that there are standards in state law to govern the
AB 389
Page 5
proper storage and delivery of blood clotting products for
private pay patients.
2)BLEEDING DISORDERS . Hemophilia is a rare, hereditary bleeding
disorder affecting approximately 4,000, mostly male,
Californians. It is a chronic, lifelong, incurable yet
treatable disease marked by the absence of blood proteins,
called clotting factors, that work to stop bleeding. Lack of
clotting factor causes hemophiliacs to bleed for longer
periods of time and generally results in internal bleeding,
primarily in muscles and joints. Without treatment,
hemophilia can cause pain, severe joint damage, disability,
and early death. Von Willebrand disease is another bleeding
disorder caused by a deficiency or defect of a blood clotting
protein called von Willebrand factor. It is considered less
severe than hemophilia and is estimated to affect 360,000
Californians.
3)BLOOD CLOTTING PRODUCTS . Hemophilia and other bleeding
disorders are treated by replacing the missing clotting factor
in the blood through injections of additional blood clotting
factors into the bloodstream. Clotting factors used to treat
hemophilia are approved by the FDA and can only be used with a
prescription. Clotting factors are found in whole blood,
plasma, and recombinant factors, which are made in a
laboratory and do not involve human blood products. A number
of blood clotting products, made by a variety of
pharmaceutical manufacturers, may be prescribed to temporarily
replace the missing clotting factors in order to prevent or
contain bleeding episodes. 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 as they are sensitive to
extreme exposure to light.
4)PUBLIC PROGRAMS . As of July 1, 2010, pharmacies providing
blood clotting factors to patients in Medi-Cal, the California
Children's Services Program, 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, handling, and delivery of
AB 389
Page 6
clotting factor concentrates and ancillary supplies;
processing of prescription orders; hours of operation and
access to staff; and, recordkeeping, billing, and product
recalls. The author contends that this bill will ensure that
the standards in these contracts are codified in statute to
ensure that pharmacies have proper safeguards in place to
provide for the safety and well-being of privately-insured
patients in California who have hemophilia or other bleeding
disorders.
5)SPECIALIZED PHARMACIES . Many blood clotting product providers
in the state are specialty care pharmacies. These 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. Specialty care pharmacies are
subject to the same statutory and regulatory requirements as
traditional pharmacies, but they do not need to meet
additional licensing requirements in order to provide their
specialized services. 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, they provide or arrange for nursing services to
patients who need assistance with infusing the blood factor
products.
6)PRIOR LEGISLATION .
a) SB 971 (Pavley) of 2010, which was substantially similar
to this bill, was vetoed by Governor Schwarzenegger. In
his veto message, the Governor stated that SB 971 was
unnecessary 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.
b) 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 died on the Senate
Appropriations Committee Suspense File.
7)SUPPORT . Providers, manufacturers of blood clotting products,
and patient advocacy groups support this bill because it would
establish crucial standards of care for health care entities
AB 389
Page 7
that deliver blood factor products to people with hemophilia
and other life-threatening blood disorders in the home
setting. The sponsor of this bill, Hemophilia Council of
California, writes that it is critical to ensure that the
strict standards for the storage and delivery of blood
clotting factor currently included in state contracts are
codified in statute for both public and private paying
patients in California. Community Healthcare Services and
Walgreens state that this bill will promote access to a full
range of essential and cost effective blood clotting products
and related equipment to enable people with bleeding disorders
to lead normal lives, free of pain and crippling arthritis.
Pfizer notes in support that timely access to appropriate
blood clotting products and infusion services is extremely
cost effective and reduces mortality and bleeding-related
hospitalizations. CSL Behring and other makers of
plasma-protein therapies write that individuals with blood
disorders need to receive timely access to the full range of
blood clotting therapies and the standards specified in this
bill will help make treatment for these patients
cost-effective and reduce mortality and bleeding-related
hospitalization.
8)DOUBLE REFERRAL . This bill is double referred. It was heard
in the Assembly Committee on Business, Professions and
Consumer Protection on March 22, 2011 and passed out on a 9-0
vote.
REGISTERED SUPPORT / OPPOSITION :
Support
Hemophilia Council of California (sponsor)
Baxter Healthcare
Community Healthcare Services
CSL Behring
Federal Hemophilia Treatment Centers - Region IX
Grifols Inc.
Hemophilia Foundation Northern California
Herndon Pharmacy
National Cornerstone Health Care Services, Inc.
Pfizer
Red Chip Enterprises
Walgreens
AB 389
Page 8
Opposition
None on file.
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097