PRINTER'S NO. 1308
No. 1030 Session of 2007
INTRODUCED BY LOGAN, MUSTO, TARTAGLIONE, MELLOW, RHOADES,
O'PAKE, BROWNE, LAVALLE, COSTA, WONDERLING, ORIE, KITCHEN,
FONTANA, WASHINGTON AND GORDNER, JULY 14, 2007
REFERRED TO PUBLIC HEALTH AND WELFARE, JULY 14, 2007
AN ACT
1 Providing a standard of care for the treatment of persons with
2 bleeding disorders.
3 The General Assembly of the Commonwealth of Pennsylvania
4 hereby enacts as follows:
5 Section 1. Short title.
6 This act shall be known and may be cited as the Hemophilia
7 Standards of Care Act.
8 Section 2. Declaration of policy.
9 The General Assembly finds and declares as follows:
10 (1) Hemophilia is a rare, hereditary bleeding disorder
11 affecting at least 1,700 individuals in this Commonwealth. It
12 is a chronic, lifelong, incurable disease.
13 (2) Until the 1970s, persons afflicted with severe
14 hemophilia suffered from uncontrollable internal bleeding,
15 crippling orthopedic deformities and a diminished lifespan.
16 (3) The scientific discovery of highly purified blood
17 clotting factors has enabled many persons with hemophilia the
1 opportunity to lead normal lives free of pain and crippling
2 arthritis.
3 (4) The blood clotting factors are expensive and must be
4 injected intravenously several times per week, but this
5 medicine can be administered in the patient's home, the
6 preferred method of treatment.
7 (5) In addition to blood clotting factors, patients
8 require expert, specialized medical care at a regional
9 hemophilia treatment program affiliated with a hospital.
10 (6) The purpose of this act is to establish a standard
11 of care so that patients with severe bleeding disorders can
12 receive necessary and appropriate medical care.
13 Section 3. Definitions.
14 The following words and phrases when used in this act shall
15 have the meanings given to them in this section unless the
16 context clearly indicates otherwise:
17 "340B program." An outpatient pharmacy licensed by the
18 Commonwealth to dispense blood clotting products and which is
19 conditionally or fully designated as a covered entity under the
20 Veterans Health Care Act of 1992 (Public Law 102-585, 106 Stat.
21 4943), which enacted section 340B of the Public Health Service
22 Act (58 Stat. 682, 42 U.S.C. § 256b).
23 "Ancillary infusion equipment and supplies." The equipment
24 and supplies required to infuse a blood clotting product into a
25 human vein, including, but not limited to, syringes, needles,
26 sterile gauze and alcohol swabs, tourniquets, medical tape,
27 sharps or equivalent biohazard waste containers and cold
28 compression packs.
29 "Bleeding disorder." A medical condition characterized by a
30 severe deficiency or absence of one or more essential blood
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1 clotting proteins in the human blood, often called factors,
2 including all forms of hemophilia, von Willebrand disease and
3 other bleeding disorders which result in uncontrollable bleeding
4 or abnormal blood clotting.
5 "Blood clotting product." An intravenously administered
6 medicine manufactured from human plasma or recombinant
7 biotechnology techniques, approved for distribution by the Food
8 and Drug Administration and which is used for the treatment and
9 prevention of symptoms associated with bleeding disorders. The
10 term includes, but is not limited to:
11 (1) Factor VIIa, Factor VIII and Factor IX products.
12 (2) Von Willebrand Factor products.
13 (3) Prothrombin complex concentrates.
14 (4) Activated prothrombin complex concentrates.
15 (5) Other products approved by the FDA for the treatment
16 of bleeding disorders and associated inhibitors.
17 "Clinical coagulation laboratory." A laboratory affiliated
18 with a State-recognized hemophilia program which is able to
19 diagnose bleeding disorders and perform specialized coagulation
20 studies of human blood for patients with bleeding disorders.
21 "Covered person." An individual who is entitled to receive
22 health care benefits or coverage from a health care insurer.
23 "Department." The Department of Health of the Commonwealth.
24 "Drug formulary." A schedule of prescription drugs or
25 preferred therapeutic agents, including blood clotting products,
26 approved for use by a health care insurer or its agent, which
27 will be covered and dispensed through participating pharmacies.
28 "FDA." The United States Food and Drug Administration.
29 "Full-service home care pharmacy." A vendor or provider of
30 blood clotting products, ancillary infusion equipment, home
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1 nursing services and patient assistance for the management of
2 bleeding disorders in the home setting that does the following:
3 (1) Supplies blood clotting products and home nursing
4 services as prescribed by the covered person's treating
5 physician and does not make any substitutions of blood
6 clotting products without the prior approval of the treating
7 physician.
8 (2) Supplies all FDA-approved brands of blood clotting
9 products in multiple assay ranges, low, medium and high, as
10 applicable, including products manufactured from human plasma
11 and those manufactured with recombinant biotechnology
12 techniques.
13 (3) Supplies all needed ancillary infusion equipment and
14 supplies.
15 (4) Provides directly or through a reliable third-party
16 agency home nursing services, whenever the services are
17 prescribed and deemed necessary by the treating physician.
18 (5) Upon receiving a prescription, ships the prescribed
19 blood clotting products and ancillary infusion equipment to
20 the covered person within three business days.
21 (6) Provides a pharmacist on call, available at all
22 times to fill prescriptions for blood clotting products.
23 (7) Provides appropriate and necessary recordkeeping and
24 documentation.
25 (8) Provides administrative assistance for covered
26 persons to obtain payment for blood clotting products,
27 ancillary infusion equipment and home nursing services.
28 (9) Provides covered persons, upon request, with
29 information about the anticipated out-of-pocket costs for
30 blood clotting products, ancillary infusion equipment and
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1 services that are not otherwise paid for by the health care
2 insurer.
3 (10) Provides patient notification of recalls and
4 withdrawals of blood clotting products and ancillary infusion
5 equipment as soon as practical.
6 (11) Provides sharps containers or the equivalent for
7 the removal and disposal of medical waste.
8 (12) Is certified by the Department of Health.
9 "Health care insurer." An entity that issues an individual
10 or a group health insurance policy.
11 "Health insurance policy."
12 (1) An individual or group health insurance policy,
13 subscriber contract, certificate or plan which provides
14 medical or health care coverage by a health care facility or
15 licensed health care provider and which is offered by or is
16 governed under this act or any of the following:
17 (i) The act of May 17, 1921 (P.L.682, No.284), known
18 as The Insurance Company Law of 1921.
19 (ii) The act of December 29, 1972 (P.L.1701,
20 No.364), known as the Health Maintenance Organization
21 Act.
22 (iii) The act of May 18, 1976 (P.L.123, No.54),
23 known as the Individual Accident and Sickness Insurance
24 Minimum Standards Act.
25 (iv) 40 Pa.C.S. Ch. 61 (relating to hospital plan
26 corporations).
27 (v) 40 Pa.C.S. Ch. 63 (relating to professional
28 health services plan corporations).
29 (2) The term does not include any of the following types
30 of insurance, alone or in combination with each other:
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1 (i) Hospital indemnity.
2 (ii) Accident only policies.
3 (iii) Specified disease policies.
4 (iv) Disability income policies.
5 (v) Dental plans.
6 (vi) Vision plans.
7 (vii) CHAMPUS supplement.
8 (viii) Long-term care policies.
9 (ix) Other limited benefit plans.
10 "Hemophilia." A human bleeding disorder caused by a
11 hereditary deficiency of the Factor VIII, Factor IX or Factor XI
12 blood clotting protein in human blood.
13 "Home nursing services." Specialized nursing care provided
14 in the home setting to assist a patient in the reconstitution
15 and administration of blood clotting products.
16 "Invasive uterine surgical procedure." Any procedure
17 performed by a physician licensed in this Commonwealth that
18 involves the insertion of a surgical instrument into the human
19 uterus, including, but not limited to, the performance of a
20 hysterectomy or uterine ablation.
21 "Menorrhagia." Excessive uterine or menstrual bleeding.
22 "Participating pharmacy." An entity which enters into an
23 agreement with a health care insurer to dispense blood clotting
24 products, ancillary infusion equipment and supplies to
25 individuals with bleeding disorders.
26 "Pharmacy." A full-service home care pharmacy, a mail-order
27 pharmacy, 340B program or other dispensing pharmacy that is
28 licensed by the Commonwealth to dispense blood clotting
29 products, ancillary infusion equipment and, in the case of full-
30 service home care pharmacies, home nursing services.
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1 "Policy." A written document or contract that provides
2 health care coverage and health care benefits for a covered
3 person.
4 "Prescription" or "prescription drug." A drug or a blood
5 clotting product dispensed by order of a health care provider
6 with prescriptive authority under the laws of this Commonwealth.
7 "State-recognized hemophilia program." A facility and
8 program for the treatment of bleeding disorders that receive
9 funding from the Commonwealth as part of the Hemophilia Program
10 administered by the Division of Child and Adult Health Services
11 in the Department of Health.
12 "von Willebrand disease." A human bleeding disorder caused
13 by a hereditary deficiency or abnormality of the von Willebrand
14 Factor in human blood.
15 Section 4. Coverage.
16 (a) Products.--A health care insurer shall contract with
17 pharmacies that will provide blood clotting products as
18 prescribed by the covered person's treating physician. The
19 pharmacies shall not make any substitutions of blood clotting
20 products without the prior approval of the treating physician.
21 (b) Payments.--
22 (1) A health care insurer shall provide payment for all
23 FDA-approved brands of blood clotting products in multiple
24 assay ranges, low, medium and high, as applicable, including
25 products manufactured from human plasma and those
26 manufactured with recombinant biotechnology techniques.
27 (2) A health care insurer shall provide payment for
28 blood clotting products as prescribed by the treating
29 physician for in-patient care, out-patient care and the home
30 treatment of bleeding disorders.
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1 (c) Drug formulary.--If a health care insurer has a drug
2 formulary, including a formulary relating to specialty
3 pharmaceutical therapies, all FDA-approved blood clotting
4 products shall be included in the formulary.
5 (d) Preauthorization.--If a health care insurer requires
6 preapproval or preauthorization of a prescription for blood
7 clotting products prior to the dispensing of the same,
8 preapproval or preauthorization shall be completed within 24
9 hours or one business day, whichever is later. However, if the
10 circumstances are deemed urgent by the treating physician, then
11 preapproval or preauthorization shall be administered upon the
12 request of the treating physician.
13 (e) Ancillary infusion equipment.--When dispensing blood
14 clotting products to individuals with bleeding disorders in this
15 Commonwealth, a pharmacy shall supply ancillary infusion
16 equipment sufficient to prepare and infuse the quantity of blood
17 clotting product being dispensed.
18 Section 5. Pharmacies.
19 (a) Choice of pharmacies.--A health care insurer shall
20 provide to a covered person a choice of at least three full-
21 service home care pharmacies which demonstrate full compliance
22 with this act.
23 (b) Using other pharmacies.--A patient with hemophilia may
24 obtain blood clotting products and ancillary infusion equipment
25 from any other participating pharmacy and from the 340B program
26 affiliated with the patient's State-recognized hemophilia
27 program.
28 (c) List of pharmacies.--The department shall compile and
29 distribute, upon request, a list of full-service home care
30 pharmacies which comply with this act.
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1 Section 6. State-recognized hemophilia programs.
2 A health care insurer shall provide coverage for the
3 following services provided to persons with bleeding disorders
4 by a State-recognized hemophilia program:
5 (1) Physician services.
6 (2) Blood clotting products, if available, from a 340B
7 program or similar program associated with a State-recognized
8 hemophilia program.
9 (3) Clinical laboratory services at a hospital with a
10 State-recognized hemophilia program when a covered person's
11 treating physician determines that the use of the hospital's
12 clinical coagulation laboratory is medically necessary for
13 the screening, diagnosis, provisional diagnosis and treatment
14 of bleeding disorders or suspected bleeding disorders. The
15 term medically necessary includes, but is not limited to,
16 circumstances deemed urgent by the treating physician.
17 Section 7. Medical screening.
18 (a) Required screening.--A physician licensed in this
19 Commonwealth to provide obstetrical and gynecological services
20 shall request a medical screening for von Willebrand disease and
21 other bleeding disorders prior to advising an individual that an
22 invasive uterine surgical procedure is the most appropriate
23 treatment for menorrhagia.
24 (b) Place of screening.--The medical screening referenced in
25 subsection (a) shall be performed at a clinical coagulation
26 laboratory associated with a State-recognized hemophilia
27 program.
28 (c) Coverage for screening.--A health care insurer shall
29 provide coverage for the medical screening required under
30 subsection (a), including, but not limited to, physician's fees
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1 and diagnostic laboratory services.
2 Section 8. Applicability.
3 All health care insurers shall comply with the provisions of
4 this act.
5 Section 9. Regulations.
6 The department may adopt regulations to carry out the
7 provisions of this act.
8 Section 10. Effective date.
9 This act shall take effect in 60 days.
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