I

104TH CONGRESS

1ST SESSION H. R. 1579

To require providers of home infusion therapy services to be licensed and

to limit physician referrals for home infusion therapy services in which

the physician has a financial interest.

IN THE HOUSE OF REPRESENTATIVES

MAY 9, 1995

Mr. BROWN of Ohio introduced the following bill; which was referred to the

Committee on Commerce, and in addition to the Committee on Ways and

Means, for a period to be subsequently determined by the Speaker, in

each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL

To require providers of home infusion therapy services to

be licensed and to limit physician referrals for home

infusion therapy services in which the physician has a

financial interest.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Sarah Weber Home

5 Infusion Consumer Protection Act of 1995’’.
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1 SEC. 2. LICENSING OF PROVIDERS OF HOME INFUSION

2 THERAPY SERVICES.

3 (a) REQUIREMENT.—

4 (1) LICENSE REQUIREMENT.—No person shall

5 provide (or arrange for the provision of) home infu6 sion therapy services in a State unless the person is

7 licensed by the State in accordance with this section

8 to provide (or arrange for the provision of) such

9 services.

10 (2) LICENSING PROCEDURE.—No State shall li11 cense a person to provide (or arrange for the provi12 sion of) home infusion therapy services unless the

13 State finds that the person meets the standards for

14 licensing established under this section.

15 (3) EXCEPTION.—Paragraph (1) shall not

16 apply in the case of an individual providing home in17 fusion therapy services without compensation for

18 himself or herself or for a family or household mem19 ber.

20 (b) STANDARDS.—

21 (1) IN GENERAL.—The Secretary of Health and

22 Human Services (in this Act referred to as the ‘‘Sec23 retary’’) shall establish standards for the licensing of

24 persons providing (or arranging for the provision of)

25 home infusion therapy services consistent with this

26 subsection.
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1 (2) SUPERVISION.—A person licensed under

2 this section shall only provide (or arrange for the

3 provision of) home infusion therapy services to an

4 individual who is under the care of a physician and

5 under a plan established and periodically reviewed

6 by a physician.

7 (3) PROVIDER QUALIFICATIONS.—A person

8 shall not be licensed consistent with this section un9 less the person—

10 (A) has been determined to be capable of

11 providing, or arranging for the provision of,

12 home infusion therapy services;

13 (B) maintains clinical records on all indi14 viduals for whom the person provides (or ar15 ranges for the provision of) such services;

16 (C) adheres to written protocols and poli17 cies with respect to the provision (or arrange18 ment for the provision) of services;

19 (D) makes services available (as needed) 7

20 days a week on a 24-hour basis;

21 (E) coordinates all home infusion therapy

22 services with the patient’s physician;

23 (F) conducts a quality assessment and as24 surance program, including drug regimen re25 view and coordination of patient care;
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1 (G) assures that only trained (or licensed

2 if necessary) personnel provide infusion prod3 ucts (and any other service for which training

4 is required to safely provide the service);

5 (H) assumes responsibility for the quality

6 of services provided by others under arrange7 ments with such person;

8 (I) establishes appropriate protocols and

9 explains such protocols clearly to patients be10 fore the initiation of a treatment plan;

11 (J) is certified to be a home health agency

12 for purposes of title XVIII of the Social Secu13 rity Act or meets the requirements to be so cer14 tified; and

15 (K) meets such other requirements as the

16 Secretary may determine are necessary (i) to

17 assure the safe and effective provision of home

18 infusion therapy services, and (ii) respecting the

19 quality of the provision of such services and the

20 charges for such services.

21 A protocol referred to in subparagraph (I) shall in22 clude a provision for appropriate notification of indi23 viduals receiving home infusion therapy services in

24 the event of the cancellation of the provision of those

25 services.
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1 (c) ENFORCEMENT.—

2 (1) PROVIDERS.—Any person who provides (or

3 arranges for the provision of) home infusion therapy

4 services in violation of subsection (a)(1) is subject to

5 a civil money penalty (in an amount specified by the

6 Secretary, but not to exceed $10,000) for each such

7 violation. The Secretary may file an action to enjoin

8 persons from violating subsection (a)(1).

9 (2) STATES.—The Secretary shall establish a

10 process for determining whether or not a State is

11 complying with the requirement of subsection (a)(2).

12 Before determining that a State has not established

13 a licensing system that complies with such require14 ment, the Secretary shall provide the State with no15 tice and opportunity to respond and correct any defi16 ciencies identified by the Secretary.

17 (d) AUTHORIZATION OF APPROPRIATIONS; STATE

18 GRANTS; LICENSING FEES.—

19 (1) AUTHORIZATION OF APPROPRIATIONS.—

20 There are authorized to be appropriated to the Sec21 retary such amounts as may be necessary for the

22 Secretary to carry out this section.

23 (2) STARTUP GRANTS.—The Secretary is au24 thorized to make grants to States in order to enable
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1 those States initially to establish the licensing sys2 tem required under subsection (a)(2).

3 (3) LICENSING FEES.—Nothing in this Act

4 shall be construed as preventing a State from requir5 ing payment of a fee from a provider as a condition

6 of licensing under subsection (a)(1) in order to reim7 burse the State for the costs of operating the licens8 ing system provided under subsection (a)(2).

9 SEC. 3. LIMITATION ON PHYSICIAN REFERRALS.

10 (a) GENERAL RULE.—Except as provided in this sec11 tion, if a physician (or an immediate family member of

12 such physician) has a financial relationship with an entity

13 described in section 1877(a)(2) of the Social Security Act,

14 then the physician may not make a referral to the entity

15 for the furnishing of home infusion therapy services.

16 (b) INCORPORATION OF MEDICARE PHYSICIAN OWN17 ERSHIP AND REFERRAL PROVISIONS.—The provisions of

18 subsections (b) through (h) of section 1877 of the Social

19 Security Act (other than subsections (f) and (g)(1)) shall

20 apply with respect to subsection (a) of this section in the

21 same manner as they apply to section 1877(a) of such Act.

22 In applying the previous sentence, any reference to a ‘‘des23 ignated health service’’ is deemed to be a reference to

24 home infusion therapy services.
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1 (c) TREATMENT OF PRESCRIPTION AS A REFER2 RAL.—In applying subsection (b) and in addition to sec3 tion 1877(h)(5) of the Social Security Act, the prescrip4 tion of a drug to be administered through home infusion

5 constitutes a ‘‘referral’’ by a ‘‘referring physician’’.

6 SEC. 4. HOME INFUSION THERAPY SERVICES DEFINED.

7 For purposes of this Act, the term ‘‘home infusion

8 therapy services’’ means the nursing, pharmacy, and relat9 ed services, including medical supplies, intravenous fluids,

10 delivery, and equipment, required for the provision of

11 therapeutic agents to patients by parenteral administra12 tion, including intravenous, intra-arterial, subcutaneous,

13 epidural, intrathecal, intramuscular, and peritoneal infu14 sion, by an enteral feeding tube for the purpose of improv15 ing or maintaining an individual’s health condition in the

16 individual’s residence.

17 SEC. 5. STUDY OF MEDICARE IN-HOME COVERAGE OF CER18 TAIN INFUSION THERAPY SERVICES.

19 (a) IN GENERAL.—The Secretary shall conduct a

20 study of the feasibility and economic impact of covering

21 under part B of title XVIII of the Social Security Act on

22 an in-home basis those infusion therapy services that

23 would otherwise be covered under part A of such title.

24 (b) REPORT.—The Secretary shall submit to Con25 gress, by not later than one year after the date of the
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1 enactment of this Act, a report on the study conducted

2 under subsection (a). Such report shall include such rec3 ommendations respecting coverage of home infusion ther4 apy services under part B of title XVIII of the Social Se5 curity Act as the Secretary deems appropriate.

6 SEC. 6. EFFECTIVE DATES.

7 (a) LICENSING REQUIREMENT.—

8 (1) IN GENERAL.—Except as provided in para9 graph (2), section 2(a) shall apply to home infusion

10 therapy services provided on or after the first day of

11 the first month that begins more than 90 days after

12 the date of the enactment of this Act, without re13 gard to whether or not the Secretary Services issues

14 final regulations to carry out such section by such

15 date.

16 (2) EXCEPTION WHERE STATE LEGISLATION

17 REQUIRED.—In the case of a State which the Sec18 retary determines requires State legislation (other

19 than legislation appropriating funds) in order for the

20 State to provide for the licensing required under sec21 tion 2(a)(2), section 2(a) shall not apply in the State

22 for home infusion therapy services provided before

23 the first day of the first calendar quarter beginning

24 after the close of the first regular session of the

25 State legislature that begins after the date of the en-
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1 actment of this Act. For purposes of the previous

2 sentence, in the case of a State that has a 2-year

3 legislative session, each year of such session shall be

4 deemed to be a separate regular session of the State

5 legislature.

6 (b) LIMITATION ON REFERRALS.—Section 3 shall

7 apply to referrals made after December 31, 1995.

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