PRIOR PRINTER'S NO. 679

PRINTER'S NO.  2541

  

THE GENERAL ASSEMBLY OF PENNSYLVANIA

  

HOUSE BILL

 

No.

620

Session of

2009

  

  

INTRODUCED BY CURRY, GRUCELA, DeLUCA, ARGALL, BARRAR, BELFANTI, BEYER, BISHOP, BRENNAN, BROWN, BUXTON, CALTAGIRONE, CLYMER, COHEN, D. COSTA, P. COSTA, CREIGHTON, DALEY, DALLY, DERMODY, DeWEESE, DiGIROLAMO, DONATUCCI, FABRIZIO, FLECK, FRANKEL, FREEMAN, GEIST, GEORGE, GERBER, GIBBONS, GINGRICH, GOODMAN, GRELL, HALUSKA, HARHAI, HARKINS, HARPER, HENNESSEY, HESS, JOSEPHS, KESSLER, KILLION, KIRKLAND, KORTZ, KULA, MAHER, MANN, MARKOSEK, MARSICO, McCALL, McILVAINE SMITH, MELIO, MICOZZIE, MILNE, MUNDY, MURT, MYERS, D. O'BRIEN, M. O'BRIEN, O'NEILL, PARKER, PHILLIPS, READSHAW, REICHLEY, ROCK, ROHRER, ROSS, SAMUELSON, SANTONI, SCAVELLO, SCHRODER, SHAPIRO, SIPTROTH, K. SMITH, SOLOBAY, SONNEY, STEVENSON, J. TAYLOR, R. TAYLOR, TRUE, VULAKOVICH, WALKO, WANSACZ, WATSON, WILLIAMS, YOUNGBLOOD, SABATINA, HORNAMAN, STERN, VEREB, CIVERA, J. EVANS, RAPP, MILLER, QUINN, GERGELY, PRESTON, KOTIK, MAHONEY, CHRISTIANA, McGEEHAN, GODSHALL, MAJOR, DAY, BOYLE, BRIGGS, MOUL, BEAR, BRADFORD, PETRI, OBERLANDER, TALLMAN, STURLA, HARHART AND CRUZ, FEBRUARY 26, 2009

  

  

AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES, AUGUST 4, 2009   

  

  

  

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:

 


1

(1)  Hemophilia is a rare, hereditary bleeding disorder

2

affecting at least 1,700 individuals in this Commonwealth. It

3

is a chronic, lifelong, incurable disease.

4

(2)  Until the 1970s, persons afflicted with severe

5

hemophilia suffered from uncontrollable internal bleeding,

6

crippling orthopedic deformities and a diminished lifespan.

7

(3)  The scientific discovery of highly purified blood

8

clotting factors has enabled many persons with hemophilia the

9

opportunity to lead normal lives free of pain and crippling

10

arthritis.

11

(4)  The blood clotting factors are expensive and must be

12

injected intravenously several times per week, but this

13

medicine can be administered in the patient's home, the

14

preferred method of treatment.

15

(5)  In addition to blood clotting factors, patients

16

require expert, specialized medical care at a regional

17

hemophilia treatment program affiliated with a hospital.

18

(6)  The purpose of this act is to establish a standard

19

of care so that patients with severe bleeding disorders can

20

receive necessary and appropriate medical care.

21

Section 3.  Definitions.

22

The following words and phrases when used in this act shall

23

have the meanings given to them in this section unless the

24

context clearly indicates otherwise:

25

"340B program."  An outpatient pharmacy licensed by the

26

Commonwealth to dispense blood clotting products and which is

27

conditionally or fully designated as a covered entity under the

28

Veterans Health Care Act of 1992 (Public Law 102-585, 106 Stat.

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4943), which enacted section 340B of the Public Health Service

30

Act (58 Stat. 682, 42 U.S.C. § 256b).

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1

"Ancillary infusion equipment and supplies."  The equipment

2

and supplies required to infuse a blood clotting product into a

3

human vein, including, but not limited to, syringes, needles,

4

sterile gauze and alcohol swabs, tourniquets, medical tape,

5

sharps or equivalent biohazard waste containers and cold

6

compression packs.

7

"Bleeding disorder."  A medical condition characterized by a

8

severe deficiency or absence of one or more essential blood

9

clotting proteins in the human blood, often called factors,

10

including all forms of hemophilia, von Willebrand disease and

11

other bleeding disorders which result in uncontrollable bleeding

12

or abnormal blood clotting.

13

"Blood clotting product."  An intravenously administered

14

medicine manufactured from human plasma or recombinant

15

biotechnology techniques, approved for distribution by the Food

16

and Drug Administration and which is used for the treatment and

17

prevention of symptoms associated with bleeding disorders. The

18

term includes, but is not limited to:

19

(1)  Factor VIIa, Factor VIII and Factor IX products.

20

(2)  Von Willebrand Factor products.

21

(3)  Prothrombin complex concentrates.

22

(4)  Activated prothrombin complex concentrates.

23

(5)  Other products approved by the FDA for the treatment

24

of bleeding disorders and associated inhibitors.

25

"Clinical coagulation laboratory."  A laboratory affiliated

26

with a State-recognized State-funded hemophilia program which is

<--

27

able to diagnose bleeding disorders and perform specialized

28

coagulation studies of human blood for patients with bleeding

29

disorders.

30

"Covered person."  An individual who is entitled to receive

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1

health care benefits or coverage from a health care insurer.

2

"Department."  The Department of Health of the Commonwealth.

3

"Drug formulary."  A schedule of prescription drugs or

4

preferred therapeutic agents, including blood clotting products,

5

approved for use by a health care insurer or its agent, which

6

will be covered and dispensed through participating pharmacies.

7

"FDA."  The United States Food and Drug Administration.

8

"Full-service home care pharmacy provider."  A vendor or and 

<--

9

provider of blood clotting products, ancillary infusion

10

equipment, home nursing services and patient assistance for the

11

management of bleeding disorders in the home setting that does

<--

12

the following:

13

(1)  Supplies blood clotting products and home nursing

14

services as prescribed by the covered person's treating

15

physician and does not make any substitutions of blood

16

clotting products without the prior approval of the treating

17

physician.

18

(2)  Supplies all FDA-approved brands of blood clotting

19

products in multiple assay ranges, low, medium and high, as

20

applicable, including products manufactured from human plasma

21

and those manufactured with recombinant biotechnology

22

techniques.

23

(3)  Supplies all needed ancillary infusion equipment and

24

supplies.

25

(4)  Provides directly or through a reliable third-party

26

agency home nursing services, whenever the services are

27

prescribed and deemed necessary by the treating physician.

28

(5)  Upon receiving a prescription, ships the prescribed

29

blood clotting products and ancillary infusion equipment to

30

the covered person within three business days.

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1

(6)  Provides a pharmacist on call, available at all

2

times to fill prescriptions for blood clotting products.

3

(7)  Provides appropriate and necessary recordkeeping and

4

documentation.

5

(8)  Provides administrative assistance for covered

6

persons to obtain payment for blood clotting products,

7

ancillary infusion equipment and home nursing services.

8

(9)  Provides covered persons, upon request, with

9

information about the anticipated out-of-pocket costs for

10

blood clotting products, ancillary infusion equipment and

11

services that are not otherwise paid for by the health care

12

insurer.

13

(10)  Provides patient notification of recalls and

14

withdrawals of blood clotting products and ancillary infusion

15

equipment as soon as practical.

16

(11)  Provides sharps containers or the equivalent for

17

the removal and disposal of medical waste.

18

(12)  Is certified by the Department of Health., as

<--

19

described fully in section 5.

20

"Health care insurer."  An entity that issues an individual

21

or a group health insurance policy.

22

"Health insurance policy."

23

(1)  An individual or group health insurance policy,

24

subscriber contract, certificate or plan which provides

25

medical or health care coverage by a health care facility or

26

licensed health care provider and which is offered by or is

27

governed under this act or any of the following:

28

(i)  The act of May 17, 1921 (P.L.682, No.284), known

29

as The Insurance Company Law of 1921.

30

(ii)  The act of December 29, 1972 (P.L.1701, No.

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1

364), known as the Health Maintenance Organization Act.

2

(iii)  The act of May 18, 1976 (P.L.123, No.54),

3

known as the Individual Accident and Sickness Insurance

4

Minimum Standards Act.

5

(iv)  40 Pa.C.S. Ch. 61 (relating to hospital plan

6

corporations).

7

(v)  40 Pa.C.S. Ch. 63 (relating to professional

8

health services plan corporations).

9

(2)  The term does not include any of the following types

10

of insurance, alone or in combination with each other:

11

(i)  Hospital indemnity.

12

(ii)  Accident only policies.

13

(iii)  Specified disease policies.

14

(iv)  Disability income policies.

15

(v)  Dental plans.

16

(vi)  Vision plans.

17

(vii)  CHAMPUS supplement.

18

(viii)  Long-term care policies.

19

(ix)  Other limited benefit plans.

20

"Hemophilia."  A human bleeding disorder caused by a

21

hereditary deficiency of the Factor VIII, Factor IX or Factor XI

22

blood clotting protein in human blood.

23

"Home nursing services."  Specialized nursing care provided

24

in the home setting to assist a patient in the reconstitution

25

and administration of blood clotting products.

26

"Invasive uterine surgical procedure."  Any procedure

27

performed by a physician licensed in this Commonwealth that

28

involves the insertion of a surgical instrument into the human

29

uterus, including, but not limited to, the performance of a

30

hysterectomy or uterine ablation.

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1

"Menorrhagia."  Excessive uterine or menstrual bleeding.

2

"Participating pharmacy."  An pharmacy" or "participating

<--

3

provider."  A pharmacy or other entity which enters into an

4

agreement with a health care insurer to dispense blood clotting

5

products, ancillary infusion equipment and supplies to

6

individuals with bleeding disorders.

7

"Pharmacy."  A full-service home care pharmacy, a mail-order

<--

8

pharmacy, 340B program or other dispensing pharmacy that is

9

licensed by the Commonwealth to dispense blood clotting

10

products, ancillary infusion equipment and, in the case of full-

11

service home care pharmacies, home nursing services.

12

"Policy."  A written document or contract that provides

13

health care coverage and health care benefits for a covered

14

person.

15

"Prescription" or "prescription drug."  A drug or a blood

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clotting product dispensed by order of a health care provider

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with prescriptive authority under the laws of this Commonwealth.

18

"State-recognized "State-funded hemophilia program."  A

<--

19

facility and program for the treatment of bleeding disorders

20

that receive funding from the Commonwealth as part of the

21

Hemophilia Program administered by the Division of Child and

<--

22

Adult Health Services in the Department of Health.

23

"von Willebrand disease."  A human bleeding disorder caused

24

by a hereditary deficiency or abnormality of the von Willebrand

25

Factor in human blood.

26

Section 4.  Coverage.

27

(a)  Products.--A health care insurer shall contract with

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pharmacies that will provide blood clotting products as

29

prescribed by the covered person's treating physician. The

30

pharmacies shall not make any substitutions of blood clotting

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1

products without the prior approval of the treating physician.

2

(b)  Payments.--

3

(1)  A health care insurer shall provide payment for all

4

FDA-approved brands of blood clotting products in multiple

5

assay ranges, low, medium and high, as applicable, including

6

products manufactured from human plasma and those

7

manufactured with recombinant biotechnology techniques.

8

(2)  A health care insurer shall provide payment for

9

blood clotting products as prescribed by the treating

10

physician for in-patient care, out-patient care and the home

11

treatment of bleeding disorders.

12

(c)  Drug formulary.--If a health care insurer has a drug

13

formulary, including a formulary relating to specialty

14

pharmaceutical therapies, all FDA-approved blood clotting

15

products shall be included in the formulary.

16

(d)  Preauthorization.--If a health care insurer requires

17

preapproval or preauthorization of a prescription for blood

18

clotting products prior to the dispensing of the same,

19

preapproval or preauthorization shall be completed within 24

20

hours or one business day, whichever is later. However, if the

21

circumstances are deemed urgent by the treating physician, then

22

preapproval or preauthorization shall be administered upon the

23

request of the treating physician.

24

(e)  Ancillary infusion equipment.--When dispensing blood

25

clotting products to individuals with bleeding disorders in this

26

Commonwealth, a pharmacy shall supply ancillary infusion

27

equipment sufficient to prepare and infuse the quantity of blood

28

clotting product being dispensed.

29

Section 5.  Pharmacies Providers of products and services.

<--

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(a)  Choice of pharmacies providers.--A health care insurer

<--

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1

shall provide to a covered person a choice of at least three

2

full-service home care pharmacies which demonstrate full

<--

3

compliance with this act providers, each of which must do the

<--

4

following:

5

(1)  Supplies blood clotting products and home nursing

6

services as prescribed by the covered person's treating

7

physician and does not make any substitutions of blood

8

clotting products without the prior approval of the treating

9

physician.

10

(2)  Supplies all FDA-approved brands of blood clotting

11

products in multiple assay ranges, low, medium and high, as

12

applicable, including products manufactured from human plasma

13

and those manufactured with recombinant biotechnology

14

techniques.

15

(3)  Supplies all needed ancillary infusion equipment and

16

supplies.

17

(4)  Provides directly or through a reliable third-party

18

agency home nursing services, whenever the services are

19

prescribed and deemed necessary by the treating physician.

20

(5)  Upon receiving a prescription, sends in a single

21

shipment the prescribed blood clotting products and ancillary

22

infusion equipment to the covered person within three

23

business days.

24

(6)  Provides a pharmacist on call, available at all

25

times to fill prescriptions for blood clotting products.

26

(7)  Provides appropriate and necessary recordkeeping and

27

documentation.

28

(8)  Provides administrative assistance for covered

29

persons to obtain payment for blood clotting products,

30

ancillary infusion equipment and home nursing services.

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1

(9)  Provides covered persons, upon request, with

2

information about the anticipated out-of-pocket costs for

3

blood clotting products, ancillary infusion equipment and

4

services that are not otherwise paid for by the health care

5

insurer.

6

(10)  Provides patient notification of recalls and

7

withdrawals of blood clotting products and ancillary infusion

8

equipment as soon as practical.

9

(11)  Provides sharps containers or the equivalent for

10

the removal and disposal of medical waste.

11

(b)  Using other pharmacies providers.--A patient with

<--

12

hemophilia may obtain blood clotting products and ancillary

13

infusion equipment from any other participating pharmacy or

<--

14

provider and from the 340B program affiliated with the patient's

15

State-recognized State-funded hemophilia program.

<--

16

(c)  List of pharmacies.--The department shall compile and

<--

17

distribute, upon request, a list of full-service home care

18

pharmacies which comply with this act.

19

Section 6.  State-recognized State-funded hemophilia programs.

<--

20

A health care insurer shall provide coverage for the

21

following services provided to persons with bleeding disorders

22

by a State-recognized State-funded hemophilia program:

<--

23

(1)  Physician services.

24

(2)  Blood clotting products, if available, from a 340B

25

program or similar program associated with a State-recognized 

<--

26

State-funded hemophilia program.

<--

27

(3)  Clinical laboratory services at a hospital with a

28

State-recognized State-funded hemophilia program when a

<--

29

covered person's treating physician determines that the use

30

of the hospital's clinical coagulation laboratory is

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1

medically necessary for the screening, diagnosis, provisional

2

diagnosis and treatment of bleeding disorders or suspected

3

bleeding disorders. The term medically necessary includes,

4

but is not limited to, circumstances deemed urgent by the

5

treating physician.

6

Section 7.  Medical screening.

7

(a)  Required screening.--A physician licensed in this

8

Commonwealth to provide obstetrical and gynecological services

9

shall request a medical screening for von Willebrand disease and

10

other bleeding disorders prior to advising an individual that an

11

invasive uterine surgical procedure is the most appropriate

12

treatment for menorrhagia.

13

(b)  Place of screening.--The medical screening referenced in

14

subsection (a) shall be performed at a clinical coagulation

15

laboratory associated with a State-recognized State-funded 

<--

16

hemophilia program.

17

(c)  Coverage for screening.--A health care insurer shall

18

provide coverage for the medical screening required under

19

subsection (a), including, but not limited to, physician's fees

20

and diagnostic laboratory services.

21

Section 8.  Applicability.

22

This act shall apply to new contracts and contract renewals

<--

23

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

24

health care insurers shall comply with the provisions of this

25

act.

26

Section 9.  Regulations.

<--

27

The department may adopt regulations to carry out the

28

provisions of this act.

29

Section 10.  Effective date.

30

This act shall take effect in 60 days.

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1

Section 9.  Enforcement.

<--

2

(a)  Duties of department.--The department shall ensure

3

compliance with this act. The department may require health care

4

insurers or providers under this act to provide it with records,

5

documents and other information, including credentialing plans,

6

provider contracts and network adequacy data, necessary for it

7

to investigate the health care insurer's or provider's

8

compliance with this act.

9

(b)  Potential violations.--The department shall investigate

10

potential violations of the act based upon information provided

11

to it by covered persons, providers and other sources in order

12

to ensure compliance with this act.

13

(c)  Civil penalty.--The department may impose a civil

14

penalty of up to $5,000 for a violation of this act.

15

(d)  Injunctions.--The department may maintain an action in

16

the name of the Commonwealth for an injunction to prohibit any

17

activity which violates the provisions of this act.

18

(e)  Plan of correction.--The department may require a health

19

care insurer or provider to develop and adhere to a plan of

20

correction approved by the department. The department shall

21

monitor compliance with the plan of correction.

22

(f)  Regulations.--The department may adopt regulations to

23

carry out the provisions of this act.

24

Section 10.  Effective date.

25

This act shall take effect in 90 days.

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