THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY CURRY, BARRAR, BEAR, BISHOP, BOBACK, BRADFORD, BRIGGS, V. BROWN, BUXTON, CALTAGIRONE, CLYMER, COHEN, D. COSTA, DEASY, DeLUCA, DERMODY, DeWEESE, FABRIZIO, FREEMAN, GEIST, GEORGE, GERGELY, GIBBONS, GINGRICH, GODSHALL, GRELL, HAHN, HALUSKA, HARHAI, HARHART, HENNESSEY, HESS, HORNAMAN, JOSEPHS, KAVULICH, KILLION, KORTZ, KOTIK, LONGIETTI, MAJOR, MANN, MARSICO, MILLER, MILNE, MUNDY, MURT, MYERS, M. O'BRIEN, O'NEILL, RAPP, READSHAW, REICHLEY, ROEBUCK, SCAVELLO, SONNEY, STERN, STURLA, J. TAYLOR, TOEPEL, VULAKOVICH, WATSON AND YOUNGBLOOD, FEBRUARY 14, 2011

REFERRED TO COMMITTEE ON INSURANCE, FEBRUARY 14, 2011  

AN ACT

Providing a standard of care for the treatment of persons with

bleeding disorders; and imposing a civil penalty.

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

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 and which 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. § 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,

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

bleeding disorders in the home setting, as described fully 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 which provides

medical or health care coverage by a health care facility or

licensed health care provider and which 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.

(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 "participating provider."  A

pharmacy or other entity which 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

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 shall 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 same,

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

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 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.

(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 participating 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

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.  Applicability.

This act shall apply to new contracts and contract renewals

occurring 90 days after the effective date of this act. All

health care insurers shall comply with the provisions of this

act.

Section 9.  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

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 which 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 10.  Effective date.

This act shall take effect in 90 days.