II

103D CONGRESS

2D SESSION S. 1967

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

IN THE SENATE OF THE UNITED STATES

MARCH 24 (legislative day, FEBRUARY 22), 1994

Mr. METZENBAUM introduced the following bill; which was read twice and

referred to the Committee on Labor and Human Resources

A BILL

To require providers of home infusion therapy services to

be licensed.

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

10 in a State unless the person is licensed by the State in

11 accordance with this section to provide (or arrange for the
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1 provision of) such services. No State shall license such a

2 person unless the State finds that the person meets the

3 standards for licensing established under this section.

4 (b) STANDARDS.—

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

6 Human Services shall establish standards for the li7 censing of persons providing (or arranging for the

8 provision of) home infusion therapy services consist9 ent with this subsection.

10 (2) SUPERVISION.—A person licensed under

11 this section shall only provide (or arrange for the

12 provision of) home infusion therapy services to an

13 individual who is under the care of a physician and

14 under a plan established and periodically reviewed

15 by a physician.

16 (3) PROVIDER QUALIFICATIONS.—A person

17 shall not be licensed consistent with this section un18 less the person—

19 (A) has been determined to be capable of

20 providing, or arranging for the provision of,

21 home infusion therapy services;

22 (B) maintains clinical records on all indi23 viduals for whom the person provides (or ar24 ranges for the provision of) such services;
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1 (C) adheres to written protocols and poli2 cies with respect to the provision (or arrange3 ment for the provision) of services;

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

5 days a week on a 24-hour basis;

6 (E) coordinates all home infusion therapy

7 services with the patient’s physician;

8 (F) conducts a quality assessment and as9 surance program, including drug regimen re10 view and coordination of patient care;

11 (G) assures that only trained (or licensed

12 if necessary) personnel provide infusion prod13 ucts (and any other service for which training

14 is required to safely provide the service);

15 (H) assumes responsibility for the quality

16 of services provided by others under arrange17 ments with such person;

18 (I) establishes appropriate protocols and

19 explains such protocols clearly to patients be20 fore the initiation of a treatment plan; and

21 (J) meets such other requirements as the

22 Secretary may determine are necessary (A) to

23 assure the safe and effective provision of home

24 infusion therapy services, and (B) respecting
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1 the quality of the provision of such services and

2 the charges for such services.

3 A protocol referred to in subparagraph (I) shall in4 clude a provision for appropriate notification of indi5 viduals receiving home infusion therapy services in

6 the event of the cancellation of the provision of those

7 services.

8 (4) FEE.—A person shall not be licensed con9 sistent with this section unless the person assures

10 that charges for the provision of home infusion ther11 apy services by the person (or under arrangements

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

13 the Secretary by regulation may establish to assure

14 that the charge for such services is reasonably relat15 ed to the services actually provided.

16 (c) ENFORCEMENT.—Compliance with the require17 ments of subsection (a) shall be enforced under the Fed18 eral Trade Commission Act by the Secretary of Health

19 and Human Services. A violation of any such requirement

20 shall constitute an unfair or deceptive act or practice in

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

22 Commission Act and shall be subject to enforcement under

23 section 5(b) of such Act irrespective of whether the person

24 who committed such violation is engaged in commerce or

25 meets any other jurisdictional test in such Act. The Sec-
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1 retary shall have such procedural, investigative, and en2 forcement powers in enforcing compliance with such re3 quirements and may require the filing of reports, the pro4 duction of documents, and the appearance of witnesses as

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

6 section.

7 SEC. 3. LIMITATION ON PHYSICIAN REFERRALS.

8 (a) GENERAL RULE.—Except as provided in this sec9 tion, if a physician (or an immediate family member of

10 such physician) has a financial relationship with an entity

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

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

13 for the furnishing of home infusion therapy services.

14 (b) INCORPORATION OF MEDICARE PHYSICIAN OWN15 ERSHIP AND REFERRAL PROVISIONS.—The provisions of

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

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

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

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

20 In applying the previous sentence, any reference to a ‘‘des21 ignated health service’’ is deemed to be a reference to

22 home infusion therapy services.

23 (c) ADDITIONAL EXCEPTION FOR COMPENSATION

24 ARRANGEMENT FOR MANAGEMENT OF PATIENT AND CO25 ORDINATION OF CARE.—In applying subsection (b), in ad-
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1 dition to the exceptions described in section 1877(e) of the

2 Social Security Act, payment of reasonable compensation

3 to a physician for the management of patient and coordi4 nation of care shall not be considered to be a compensation

5 arrangement described in section 1877(a)(2)(B) of such

6 Act.

7 (d) TREATMENT OF PRESCRIPTION AS A REFER8 RAL.—In applying subsection (b) and in addition to sec9 tion 1877(h)(5) of the Social Security Act, the prescrip10 tion of a drug to be administered through home infusion

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

12 SEC. 4. HOME INFUSION THERAPY SERVICES DEFINED.

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

14 therapy services’’ means the nursing, pharmacy, and relat15 ed services, including medical supplies, intravenous fluids,

16 delivery, and equipment, required for the provision of

17 therapeutic agents to patients by parenteral administra18 tion, including intravenous, intra-arterial, subcutaneous,

19 epidural, intrathecal, intramuscular, and peritoneal infu20 sion, by an enteral feeding tube for the purpose of improv21 ing or maintaining an individual’s health condition in the

22 individual’s residence.

23 SEC. 5. EFFECTIVE DATES.

24 (a) LICENSING REQUIREMENT.—
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1 (1) IN GENERAL.—Except as provided in para2 graph (2), section 3(a) shall apply to home infusion

3 therapy services provided on or after the first day of

4 the first month that begins more than 90 days after

5 the date of the enactment of this Act, without re6 gard to whether or not the Secretary of Health and

7 Human Services issues final regulations to carry out

8 such section have been promulgated by such date.

9 (2) STATE LEGISLATION.—In the case of a

10 State which the Secretary of Health and Human

11 Services determines requires State legislation (other

12 than legislation appropriating funds) in order for the

13 State to provide for the licensing required under sec14 tion 3(a), section 3(a) shall not apply in the State

15 for home infusion therapy services provided before

16 the first day of the first calendar quarter beginning

17 after the close of the first regular session of the

18 State legislature that begins after the date of the en19 actment of this Act. For purposes of the previous

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

21 legislative session, each year of such session shall be

22 deemed to be a separate regular session of the State

23 legislature.

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

25 apply to referrals made after December 31, 1994.
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