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PRINTER'S NO. 3910
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2364
Session of
2015
INTRODUCED BY MICCARELLI, ROZZI, READSHAW, HEFFLEY, YOUNGBLOOD
AND BARRAR, SEPTEMBER 23, 2016
REFERRED TO COMMITTEE ON HEALTH, SEPTEMBER 23, 2016
AN ACT
Providing a standard of care for the treatment of persons with
bleeding disorders.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Short title.
This act shall be known and may be cited as the Hemophilia
Standards of Care Act.
Section 2. Declaration of policy.
The General Assembly finds and declares as follows:
(1) Hemophilia is a rare, hereditary bleeding disorder
affecting at least 1,700 individuals in this Commonwealth. It
is a chronic, lifelong, incurable disease.
(2) Until the 1970s, persons afflicted with severe
hemophilia suffered from uncontrollable internal bleeding,
crippling orthopedic deformities and a diminished lifespan.
(3) The scientific discovery of highly purified blood
clotting factors has enabled many persons with hemophilia the
opportunity to lead normal lives free of pain and crippling
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arthritis.
(4) The blood clotting factors are expensive and must be
injected intravenously several times per week, but this
medicine can be administered in the patient's home, the
preferred method of treatment.
(5) In addition to blood clotting factors, patients
require expert, specialized medical care at a regional
hemophilia treatment program affiliated with a hospital.
(6) The purpose of this act is to establish a standard
of care so that patients with severe bleeding disorders can
receive necessary and appropriate medical care.
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"340B program." An outpatient pharmacy licensed by the
Commonwealth to dispense blood clotting products that is
conditionally or fully designated as a covered entity under the
Veterans Health Care Act of 1992 (Public Law 102-585, 106 Stat.
4943), which enacted section 340B of the Public Health Service
Act (58 Stat. 682, 42 U.S.C. ยง 256b).
"Ancillary infusion equipment and supplies." The equipment
and supplies required to infuse a blood clotting product into a
human vein, including, but not limited to, syringes, needles,
sterile gauze and alcohol swabs, tourniquets, medical tape,
sharps or equivalent biohazard waste containers and cold
compression packs.
"Bleeding disorder." A medical condition characterized by a
severe deficiency or absence of one or more essential blood
clotting proteins in the human blood, often called factors,
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including all forms of hemophilia, von Willebrand disease and
other bleeding disorders which result in uncontrollable bleeding
or abnormal blood clotting.
"Blood clotting product." An intravenously administered
medicine manufactured from human plasma or recombinant
biotechnology techniques, approved for distribution by the Food
and Drug Administration and which is used for the treatment and
prevention of symptoms associated with bleeding disorders. The
term includes, but is not limited to:
(1) Factor VIIa, Factor VIII and Factor IX products.
(2) Von Willebrand Factor products.
(3) Prothrombin complex concentrates.
(4) Activated prothrombin complex concentrates.
(5) Other products approved by the FDA for the treatment
of bleeding disorders and associated inhibitors.
"Clinical coagulation laboratory." A laboratory affiliated
with a State-funded hemophilia program which is able to diagnose
bleeding disorders and perform specialized coagulation studies
of human blood for patients with bleeding disorders.
"Covered person." An individual who is entitled to receive
health care benefits or coverage from a health care insurer.
"Department." The Department of Health of the Commonwealth.
"Drug formulary." A schedule of prescription drugs or
preferred therapeutic agents, including blood clotting products,
approved for use by a health care insurer or its agent, which
will be covered and dispensed through participating pharmacies.
"FDA." The United States Food and Drug Administration.
"Full-service home care provider." A vendor and provider of
blood clotting products, ancillary infusion equipment, home
nursing services and patient assistance for the management of
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bleeding disorders in the home setting, as described in section
5.
"Health care insurer." An entity that issues an individual
or a group health insurance policy.
"Health insurance policy."
(1) An individual or group health insurance policy,
subscriber contract, certificate or plan that provides
medical or health care coverage by a health care facility or
licensed health care provider and is offered by or is
governed under this act or any of the following:
(i) The act of May 17, 1921 (P.L.682, No.284), known
as The Insurance Company Law of 1921.
(ii) The act of December 29, 1972 (P.L.1701, No.
364), known as the Health Maintenance Organization Act.
(iii) The act of May 18, 1976 (P.L.123, No.54),
known as the Individual Accident and Sickness Insurance
Minimum Standards Act.
(iv) 40 Pa.C.S. Ch. 61 (relating to hospital plan
corporations).
(v) 40 Pa.C.S. Ch. 63 (relating to professional
health services plan corporations).
(2) The term does not include any of the following types
of insurance, alone or in combination with each other:
(i) Hospital indemnity.
(ii) Accident only policies.
(iii) Specified disease policies.
(iv) Disability income policies.
(v) Dental plans.
(vi) Vision plans.
(vii) CHAMPUS supplement.
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(viii) Long-term care policies.
(ix) Other limited benefit plans.
"Hemophilia." A human bleeding disorder caused by a
hereditary deficiency of the Factor VIII, Factor IX or Factor XI
blood clotting protein in human blood.
"Home nursing services." Specialized nursing care provided
in the home setting to assist a patient in the reconstitution
and administration of blood clotting products.
"Invasive uterine surgical procedure." Any procedure
performed by a physician licensed in this Commonwealth that
involves the insertion of a surgical instrument into the human
uterus, including, but not limited to, the performance of a
hysterectomy or uterine ablation.
"Menorrhagia." Excessive uterine or menstrual bleeding.
"Participating pharmacy or provider." A pharmacy or other
entity that enters into an agreement with a health care insurer
to dispense blood clotting products, ancillary infusion
equipment and supplies to individuals with bleeding disorders.
"Policy." A written document or contract that provides
health care coverage and health care benefits for a covered
person.
"Prescription" or "prescription drug." A drug or a blood
clotting product dispensed by order of a health care provider
with prescriptive authority under the laws of this Commonwealth.
"State-funded hemophilia program." A facility and program
for the treatment of bleeding disorders that receive funding
from the Commonwealth as part of the Hemophilia Program
administered by the Department of Health.
"von Willebrand disease." A human bleeding disorder caused
by a hereditary deficiency or abnormality of the von Willebrand
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Factor in human blood.
Section 4. Coverage.
(a) Products.--A health care insurer shall contract with
pharmacies that will provide blood clotting products as
prescribed by the covered person's treating physician. The
pharmacies may not make any substitutions of blood clotting
products without the prior approval of the treating physician.
(b) Payments.--
(1) A health care insurer shall provide payment for all
FDA-approved brands of blood clotting products in multiple
assay ranges, low, medium and high, as applicable, including
products manufactured from human plasma and those
manufactured with recombinant biotechnology techniques.
(2) A health care insurer shall provide payment for
blood clotting products as prescribed by the treating
physician for in-patient care, out-patient care and the home
treatment of bleeding disorders.
(c) Drug formulary.--If a health care insurer has a drug
formulary, including a formulary relating to specialty
pharmaceutical therapies, all FDA-approved blood clotting
products shall be included in the formulary.
(d) Preauthorization.--If a health care insurer requires
preapproval or preauthorization of a prescription for blood
clotting products prior to the dispensing of the products,
preapproval or preauthorization shall be completed within 24
hours or one business day, whichever is later. However, if the
circumstances are deemed urgent by the treating physician, then
preapproval or preauthorization shall be administered upon the
request of the treating physician.
(e) Ancillary infusion equipment.--When dispensing blood
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clotting products to individuals with bleeding disorders in this
Commonwealth, a pharmacy shall supply ancillary infusion
equipment sufficient to prepare and infuse the quantity of blood
clotting product being dispensed.
Section 5. Providers of products and services.
(a) Choice of providers.--A health care insurer shall
provide to a covered person a choice of at least three full-
service home care providers, each of which must do all of the
following:
(1) Supplies blood clotting products and home nursing
services as prescribed by the covered person's treating
physician and does not make any substitutions of blood
clotting products without the prior approval of the treating
physician.
(2) Supplies all FDA-approved brands of blood clotting
products in multiple assay ranges, low, medium and high, as
applicable, including products manufactured from human plasma
and those manufactured with recombinant biotechnology
techniques.
(3) Supplies all needed ancillary infusion equipment and
supplies.
(4) Provides directly or through a reliable third-party
agency home nursing services, whenever the services are
prescribed and deemed necessary by the treating physician.
(5) Upon receiving a prescription, sends in a single
shipment the prescribed blood clotting products and ancillary
infusion equipment to the covered person within three
business days.
(6) Provides a pharmacist on call, available at all
times to fill prescriptions for blood clotting products.
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(7) Provides appropriate and necessary recordkeeping and
documentation.
(8) Provides administrative assistance for covered
persons to obtain payment for blood clotting products,
ancillary infusion equipment and home nursing services.
(9) Provides covered persons, upon request, with
information about the anticipated out-of-pocket costs for
blood clotting products, ancillary infusion equipment and
services that are not otherwise paid for by the health care
insurer.
(10) Provides patient notification of recalls and
withdrawals of blood clotting products and ancillary infusion
equipment as soon as practical.
(11) Provides sharps containers or the equivalent for
the removal and disposal of medical waste.
(b) Using other providers.--A patient with hemophilia may
obtain blood clotting products and ancillary infusion equipment
from any other participating pharmacy or provider and from the
340B program affiliated with the patient's State-funded
hemophilia program.
Section 6. State-funded hemophilia programs.
A health care insurer shall provide coverage for the
following services provided to persons with bleeding disorders
by a State-funded hemophilia program:
(1) Physician services.
(2) Blood clotting products, if available, from a 340B
program or similar program associated with a State-funded
hemophilia program.
(3) Clinical laboratory services at a hospital with a
State-funded hemophilia program when a covered person's
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treating physician determines that the use of the hospital's
clinical coagulation laboratory is medically necessary for
the screening, diagnosis, provisional diagnosis and treatment
of bleeding disorders or suspected bleeding disorders. The
term medically necessary includes, but is not limited to,
circumstances deemed urgent by the treating physician.
Section 7. Medical screening.
(a) Required screening.--A physician licensed in this
Commonwealth to provide obstetrical and gynecological services
shall request a medical screening for von Willebrand disease and
other bleeding disorders prior to advising an individual that an
invasive uterine surgical procedure is the most appropriate
treatment for menorrhagia.
(b) Place of screening.--The medical screening referenced in
subsection (a) shall be performed at a clinical coagulation
laboratory associated with a State-funded hemophilia program.
(c) Coverage for screening.--A health care insurer shall
provide coverage for the medical screening required under
subsection (a), including, but not limited to, physician's fees
and diagnostic laboratory services.
Section 8. Enforcement.
(a) Duties of department.--The department shall ensure
compliance with this act. The department may require health care
insurers or providers under this act to provide it with records,
documents and other information, including credentialing plans,
provider contracts and network adequacy data, necessary for it
to investigate the health care insurer's or provider's
compliance with this act.
(b) Potential violations.--The department shall investigate
potential violations of the act based upon information provided
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to it by covered persons, providers and other sources in order
to ensure compliance with this act.
(c) Civil penalty.--The department may impose a civil
penalty of up to $5,000 for a violation of this act.
(d) Injunctions.--The department may maintain an action in
the name of the Commonwealth for an injunction to prohibit any
activity that violates the provisions of this act.
(e) Plan of correction.--The department may require a health
care insurer or provider to develop and adhere to a plan of
correction approved by the department. The department shall
monitor compliance with the plan of correction.
(f) Regulations.--The department may adopt regulations to
carry out the provisions of this act.
Section 9. Applicability.
This act shall apply to new contracts and contract renewals
entered into 90 days after the effective date of this act. All
health care insurers shall comply with the provisions of this
act.
Section 10. Effective date.
This act shall take effect in 90 days.
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