I

103D CONGRESS

2D SESSION H. R. 4128

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

to limit physician referrals for services in which the physician has a

financial interest.

IN THE HOUSE OF REPRESENTATIVES

MARCH 24, 1994

Mr. BROWN of Ohio (for himself, Mr. DINGELL, Mr. WAXMAN, and Mr.

STOKES) introduced the following bill; which was referred jointly to the

Committees on Energy and Commerce and Ways and Means

A BILL

To require providers of home infusion therapy services to

be licensed and to limit physician referrals for 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 1994’’.

6 SEC. 2. LICENSING OF PROVIDERS OF HOME INFUSION

7 THERAPY SERVICES.

8 (a) REQUIREMENT.—No person shall provide (or ar9 range for the provision of) home infusion therapy services
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1 in a State unless the person is licensed by the State in

2 accordance with this section to provide (or arrange for the

3 provision of) such services. No State shall license such a

4 person unless the State finds that the person meets the

5 standards for licensing established under this section.

6 (b) STANDARDS.—

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

8 Human Services shall establish standards for the li9 censing of persons providing (or arranging for the

10 provision of) home infusion therapy services consist11 ent with this subsection.

12 (2) SUPERVISION.—A person licensed under

13 this section shall only provide (or arrange for the

14 provision of) home infusion therapy services to an

15 individual who is under the care of a physician and

16 under a plan established and periodically reviewed

17 by a physician.

18 (3) PROVIDER QUALIFICATIONS.—A person

19 shall not be licensed consistent with this section un20 less the person—

21 (A) has been determined to be capable of

22 providing, or arranging for the provision of,

23 home infusion therapy services;
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1 (B) maintains clinical records on all indi2 viduals for whom the person provides (or ar3 ranges for the provision of) such services;

4 (C) adheres to written protocols and poli5 cies with respect to the provision (or arrange6 ment for the provision) of services;

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

8 days a week on a 24-hour basis;

9 (E) coordinates all home infusion therapy

10 services with the patient’s physician;

11 (F) conducts a quality assessment and as12 surance program, including drug regimen re13 view and coordination of patient care;

14 (G) assures that only trained (or licensed

15 if necessary) personnel provide infusion prod16 ucts (and any other service for which training

17 is required to safely provide the service);

18 (H) assumes responsibility for the quality

19 of services provided by others under arrange20 ments with such person;

21 (I) establishes appropriate protocols and

22 explains such protocols clearly to patients be23 fore the initiation of a treatment plan; and

24 (J) meets such other requirements as the

25 Secretary may determine are necessary (A) to
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1 assure the safe and effective provision of home

2 infusion therapy services, and (B) respecting

3 the quality of the provision of such services and

4 the charges for such services.

5 A protocol referred to in subparagraph (I) shall in6 clude a provision for appropriate notification of indi7 viduals receiving home infusion therapy services in

8 the event of the cancellation of the provision of those

9 services.

10 (4) FEE.—A person shall not be licensed con11 sistent with this section unless the person assures

12 that charges for the provision of home infusion ther13 apy services by the person (or under arrangements

14 made by the person) shall not exceed such a fee as

15 the Secretary by regulation may establish to assure

16 that the charge for such services is reasonably

17 related to the services actually provided.

18 (c) ENFORCEMENT.—Compliance with the require19 ments of subsection (a) shall be enforced under the Fed20 eral Trade Commission Act by the Secretary of Health

21 and Human Services. A violation of any such requirement

22 shall constitute an unfair or deceptive act or practice in

23 commerce in violation of section 5(a) of the Federal Trade

24 Commission Act and shall be subject to enforcement under

25 section 5(b) of such Act irrespective of whether the person
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1 who committed such violation is engaged in commerce or

2 meets any other jurisdictional test in such Act. The Sec3 retary shall have such procedural, investigative, and en4 forcement powers in enforcing compliance with such re5 quirements and may require the filing of reports, the pro6 duction of documents, and the appearance of witnesses as

7 though the applicable terms of such Act were part of this

8 section.

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. EFFECTIVE DATES.

18 (a) LICENSING REQUIREMENT.—

19 (1) IN GENERAL.—Except as provided in para20 graph (2), section 3(a) shall apply to home infusion

21 therapy services provided on or after the first day of

22 the first month that begins more than 90 days after

23 the date of the enactment of this Act, without re24 gard to whether or not the Secretary of Health and
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1 Human Services issues final regulations to carry out

2 such section have been promulgated by such date.

3 (2) In the case of a State which the Secretary

4 of Health and Human Services determines requires

5 State legislation (other than legislation appropriat6 ing funds) in order for the State to provide for the

7 licensing required under section 3(a), section 3(a)

8 shall not apply in the State for home infusion ther9 apy services provided before the first day of the first

10 calendar quarter beginning after the close of the

11 first regular session of the State legislature that be12 gins after the date of the enactment of this Act. For

13 purposes of the previous sentence, in the case of a

14 State that has a 2-year legislative session, each year

15 of such session shall be deemed to be a separate reg16 ular session of the State legislature.

17 (b) LIMITATION ON REFERRALS.—Section 4 shall

18 apply to referrals made after December 31, 1994.

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