BILL NUMBER: AB 389 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY MARCH 15, 2011
AMENDED IN ASSEMBLY MARCH 7, 2011
INTRODUCED BY Assembly Member Mitchell
(Principal coauthor: Senator Pavley)
FEBRUARY 14, 2011
An act to amend Section 2191 of the Business and Professions Code,
and to add Article 5 (commencing with Section 125286.10) to Chapter
2 of Part 5 of Division 106 of the Health and Safety Code, relating
to genetic diseases.
LEGISLATIVE COUNSEL'S DIGEST
AB 389, as amended, Mitchell. Bleeding disorders.
Existing law, the Holden-Moscone-Garamendi Genetically Handicapped
Person's Program, requires the Director of Health Care Services to
establish and administer a program for the medical care of persons
with genetically handicapping conditions, including hemophilia.
This bill would impose specified requirements on providers of
blood clotting products for home use, as described, whose products
are used for the treatment and prevention of symptoms associated with
bleeding disorders, including all forms of hemophilia. This bill
would require the California State Board of Pharmacy to administer
and enforce these provisions.
Existing law requires the Division of Licensing of the Medical
Board of California to establish continuing education requirements
for physicians and surgeons.
This bill would require the division to consider including a
course on bleeding disorders, as specified, in determining its
continuing education requirements.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 2191 of the Business and Professions Code is
amended to read:
2191. (a) In determining its continuing education requirements,
the Division of Licensing shall consider including a course in human
sexuality as defined in Section 2090 and nutrition to be taken by
those licensees whose practices may require knowledge in those areas.
(b) The division shall consider including a course in child abuse
detection and treatment to be taken by those licensees whose
practices are of a nature that there is a likelihood of contact with
abused or neglected children.
(c) The division shall consider including a course in acupuncture
to be taken by those licensees whose practices may require knowledge
in the area of acupuncture and whose education has not included
instruction in acupuncture.
(d) The division shall encourage every physician and surgeon to
take nutrition as part of his or her continuing education,
particularly a physician and surgeon involved in primary care.
(e) The division shall consider including a course in elder abuse
detection and treatment to be taken by those licensees whose
practices are of a nature that there is a likelihood of contact with
abused or neglected persons 65 years of age and older.
(f) In determining its continuing education requirements, the
division shall consider including a course in the early detection and
treatment of substance abusing pregnant women to be taken by those
licensees whose practices are of a nature that there is a likelihood
of contact with these women.
(g) In determining its continuing education requirements, the
division shall consider including a course in the special care needs
of drug addicted infants to be taken by those licensees whose
practices are of a nature that there is a likelihood of contact with
these infants.
(h) In determining its continuing education requirements, the
division shall consider including a course providing training and
guidelines on how to routinely screen for signs exhibited by abused
women, particularly for physicians and surgeons in emergency,
surgical, primary care, pediatric, prenatal, and mental health
settings. In the event the division establishes a requirement for
continuing education coursework in spousal or partner abuse detection
or treatment, that requirement shall be met by each licensee within
no more than four years from the date the requirement is imposed.
(i) In determining its continuing education requirements, the
division shall consider including a course in the special care needs
of individuals and their families facing end-of-life issues,
including, but not limited to, all of the following:
(1) Pain and symptom management.
(2) The psycho-social psychosocial
dynamics of death.
(3) Dying and bereavement.
(4) Hospice care.
(j) In determining its continuation education requirements, the
division shall give its highest priority to considering a course on
pain management.
(k) In determining its continuing education requirements, the
division shall consider including a course on bleeding disorders,
with particular emphasis on von Willebrand disease using the latest
treatment guidelines adopted by the National Heart, Lung, and Blood
Institute.
SEC. 2. Article 5 (commencing with Section 125286.10) is added to
Chapter 2 of Part 5 of Division 106 of the Health and Safety Code, to
read:
Article 5. Standards of Service for Providers of Blood
Clotting Products for Home Use Act
125286.10. This article shall be known, and may be cited, as the
Standards of Service for Providers of Blood Clotting Products for
Home Use Act.
125286.15. The Legislature hereby finds and declares all of the
following:
(a) Hemophilia is a rare, hereditary, bleeding disorder affecting
at least 4,000 persons in California and is a chronic, lifelong, and
incurable, but treatable, disease.
(b) Von Willebrand disease is a human bleeding disorder caused by
a hereditary deficiency or abnormality of the von Willebrand factor
in human blood, which is a protein that helps clot blood. Von
Willebrand disease is a chronic, lifelong, incurable, but treatable,
disease affecting at least 360,000 Californians.
(c) Until the 1970s, people with severe hemophilia suffered from
uncontrollable internal bleeding, crippling orthopedic deformities,
and a shortened lifespan. More recently, the production of highly
purified blood clotting factors has provided people with hemophilia
and other bleeding disorders the opportunity to lead normal lives,
free of pain and crippling arthritis.
(d) The preferred method of treatment of hemophilia today is
intravenous injection, or infusion, of prescription blood clotting
products several times per week, along with case management and
specialized medical care at a federally designated regional
hemophilia treatment center.
(e) Pharmacies and other entities specializing in the delivery of
blood clotting products and related equipment, supplies, and services
for home use form a growing enterprise in California.
(f) Timely access to federally designated regional hemophilia
centers and appropriate products and services in the home, including
infusion of blood clotting products and related equipment, and
supplies and services for persons with hemophilia and other bleeding
disorders, reduces mortality and bleeding-related hospitalizations
according to the federal Centers for Disease Control and Prevention
and the Medical and Scientific Advisory Council of the National
Hemophilia Foundation.
(g) Eligible persons with hemophilia or other bleeding disorders
may receive treatment through the Genetically Handicapped Persons
Program, the California Children's Services Program, and the Medi-Cal
program.
(h) For the benefit of persons with hemophilia or other bleeding
disorders, the purposes of this article are to do the following:
(1) Establish standards of service for entities that deliver blood
clotting products and related equipment, supplies, and services for
home use.
(2) Promote access to a full range of essential, cost-effective,
lifesaving, blood clotting products and related equipment, supplies,
and high-quality services for home use for persons with hemophilia
and other bleeding disorders.
125286.20. Unless the context otherwise requires, the following
definitions shall apply for purposes of this article:
(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, 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, without
treatment, result in uncontrollable bleeding or abnormal blood
clotting.
(d) "Blood clotting product" means an intravenously administered
medicine manufactured from human plasma or recombinant biotechnology
techniques, approved for distribution by the federal Food and Drug
Administration, 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" means care as defined in Section 1317.1.
(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 (HRSA) of the United States Department of Health and
Human Services.
(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. Places where home use occurs
include, without limitation, a home or other nonclinical setting.
(j) "Patient" means a person needing a blood clotting product for
home use.
(k) (1) "Provider of blood clotting products for home use" means
all the following pharmacies, except as described in Section
125286.35, that dispense blood clotting factors for home use:
(A) Hospital pharmacies.
(B) Health system pharmacies.
(C) Pharmacies affiliated with hemophilia treatment centers.
(D) Specialty home care pharmacies.
(E) Retail pharmacies.
(2) The providers described in this subdivision may also provide
home nursing services for persons with bleeding disorders.
(3) The providers described in this subdivision shall 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.
125286.25. 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 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) Maintain 24-hour on-call service seven days a week for every
day of the year, adequately screen telephone calls for emergencies,
acknowledge all telephone calls within one hour or less, and 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 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.
(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) When home nursing services are necessary, as determined by the
treating physician, provide these services 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) Upon receiving approved authorization for a nonemergency
prescription, provided manufacturer supply exists, ship the
prescribed blood clotting products and ancillary infusion equipment
and supplies to the patient within two business days or less for
established and new patients.
(i) Upon receiving approved authorization to dispense a
prescription for an emergency situation, provided manufacturer supply
exists, 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.
(j) Provide patients who have ordered their products with a
designated contact telephone number for reporting problems with a
delivery and respond to these calls within a reasonable time period.
(k) 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.
(l) Provide language interpretive services over the phone
telephone or in person, as needed by the
patient.
(m) Have a detailed plan for meeting the requirements of this
article in the event of a natural or manmade disaster or other
disruption of normal business operations.
(n) Provide the patient with a sharps container and instructions
on how to dispose of medical waste sharps. However, the provider of
blood clotting products shall not be liable for any acts or omissions
of the patient in the handling and disposal of medical waste.
(o)
(n) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and retain copies
of the patient's prescriptions.
(p)
(o) Comply with the privacy and confidentiality
requirements of the federal Health Insurance Portability and
Accountability Act of 1996 (HIPAA).
125286.30. The California State Board of Pharmacy shall
administer and enforce this article.
125286.35. Nothing in this article shall apply 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.