PRINTER'S NO. 1608
No. 1187 Session of 1997
INTRODUCED BY SERAFINI, GEIST, E. Z. TAYLOR, MELIO, TIGUE,
YOUNGBLOOD, BOSCOLA, WASHINGTON AND DeLUCA, APRIL 29, 1997
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
APRIL 29, 1997
AN ACT
1 Amending the act of June 13, 1967 (P.L.31, No.21), entitled "An
2 act to consolidate, editorially revise, and codify the public
3 welfare laws of the Commonwealth," providing for home
4 intravenous drug therapy services.
5 The General Assembly of the Commonwealth of Pennsylvania
6 hereby enacts as follows:
7 Section 1. The act of June 13, 1967 (P.L.31, No.21), known
8 as the Public Welfare Code, is amended by adding a section to
9 read:
10 Section 443.7. Home Intravenous Drug Therapy Services.--(a)
11 Reimbursement for home intravenous drug therapy services shall
12 not exceed an amount equal to the lesser of the qualified
13 provider's usual and customary charges for these services or the
14 reimbursement schedule established under subsection (b) when
15 determined medically necessary by the department. A
16 reimbursement schedule established under this section shall be
17 on a per diem basis. Service per diem rates shall include the
18 following:
1 (1) Pharmacy sterile compounding fees.
2 (2) Intravenous pole, infusion pumps and pump cassettes.
3 (3) All required intravenous supplies, such as syringes,
4 tubing and catheter-care kits.
5 (4) Any other related services necessary for home
6 intravenous drug services.
7 (b) The department shall establish a reimbursement schedule
8 for the following:
9 (1) Home intravenous antibiotics.
10 (2) Chemotherapy.
11 (3) Pain management.
12 (4) Total parenteral nutrition.
13 (5) Other home intravenous therapies.
14 (c) Reimbursement shall be the average wholesale cost of
15 drug and solution plus a service per diem not exceeding the
16 fortieth percentile of average daily medical assistance per diem
17 to Commonwealth hospitals or the usual and customary
18 reimbursement, whichever is lower.
19 (d) The referring physician prescribing the home intravenous
20 therapy shall be reimbursed payment for certain clinical
21 management services determined by the department. The schedule
22 of physician fees for these services shall not exceed on a per
23 diem basis the fortieth percentile of average reimbursement fees
24 paid to physicians for Commonwealth hospital visits or the usual
25 and customary reimbursement, whichever is lower.
26 (e) Except as provided in subsection (f), no payment for
27 home intravenous drug therapy services shall be made to any
28 qualified provider in which a physician or a physician's
29 immediate family member has an ownership interest in the
30 provider or in any situation where the physician receives
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1 compensation from the provider to induce referrals. This section
2 shall not be construed to apply to a referring physician whose
3 only ownership or financial relationship with the provider is an
4 uncompensated officer or director of the provider.
5 (f) Subsection (e) does not apply if:
6 (1) The ownership interest is the ownership of stock which
7 is traded over a publicly regulated exchange and was purchased
8 on terms generally available to the public.
9 (2) The compensation is reasonably related to items or
10 services actually provided by the physician and does not vary in
11 proportion to the number of referrals made by the referring
12 physicians, but such exception does not apply to compensation
13 provided for direct patient care services.
14 (g) No payment may be made under this act for home
15 intravenous drug therapy service which is provided in violation
16 of this act.
17 (h) No person or entity shall sell intravenous drugs in this
18 Commonwealth or deliver the same into this Commonwealth through
19 United States mail or a private carrier unless licensed by the
20 State Board of Pharmacy.
21 (i) The provisions of this act shall not be deemed to grant
22 the State Board of Pharmacy any authority to regulate the
23 practice of nursing in this Commonwealth.
24 (j) As used in this section:
25 "Home intravenous drug therapy services" means the items and
26 services furnished to an individual who is under the care of a
27 physician in a place of residence used as the individual's home,
28 by a qualified home intravenous drug therapy provider and under
29 a plan established and periodically reviewed by a physician. The
30 term includes pharmacy and related services, including medical
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1 supplies, intravenous fluids and equipment used in administering
2 intravenous fluid, as are necessary to safely and effectively
3 conduct an intravenously administered drug regimen.
4 "Qualified provider" means any entity that the State Board of
5 Pharmacy determines meets the following requirements:
6 (1) The entity is capable of providing home intravenous drug
7 therapy services.
8 (2) The entity maintains clinical records on all patients.
9 (3) The entity adheres to the appropriate written protocols
10 and policies with respect to the provision of items and
11 services.
12 (4) The entity makes services available as needed seven days
13 a week on a twenty-four-hour basis.
14 (5) The entity coordinates all services with the patient's
15 physician.
16 (6) The entity conducts a quality assessment and assurance
17 program, including drug regimen review and coordination of
18 patient care.
19 (7) The entity is licensed by the State Board of Pharmacy.
20 (8) The entity provides sterile compounding of intravenous
21 drugs in an atmosphere which contains less than one thousand
22 particles five-tenths of a micron or larger in diameter per
23 cubic foot of air and positive air flow. Clean air hoods must be
24 certified at least annually.
25 (9) The entity performs stringent quality control
26 procedures, including complete sterile compounding records of
27 drug lot number, expiration date, quantity used and copy of the
28 label attached to the final compounded product.
29 (10) The entity maintains patient records as to frequency of
30 nursing visits, certificate of medical necessity from the
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1 attending physician, progress reports on the patient and a
2 patient care plan.
3 (11) The entity meets such other requirements the State
4 Board of Pharmacy may determine are necessary to assure the safe
5 and effective provision of home intravenous drug therapy
6 services and the efficient administration of home intravenous
7 drug therapy.
8 "Referring physician" means, with respect to providing home
9 intravenous drug therapy services to an individual, a physician
10 who:
11 (1) Prescribed the home intravenous drug for which the
12 services are to be provided.
13 (2) Established the plan of care for such services.
14 Section 2. All acts and parts of acts are repealed insofar
15 as they are inconsistent with this act.
16 Section 3. This act shall take effect in 60 days.
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