```

[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 1967 Introduced in Senate (IS)]

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Sarah Weber Home Infusion Consumer 
Protection Act of 1994''.

SEC. 2. LICENSING OF PROVIDERS OF HOME INFUSION THERAPY SERVICES.

    (a) Requirement.--No person shall provide (or arrange for the 
provision of) home infusion therapy services in a State unless the 
person is licensed by the State in accordance with this section to 
provide (or arrange for the provision of) such services. No State shall 
license such a person unless the State finds that the person meets the 
standards for licensing established under this section.
    (b) Standards.--
            (1) In general.--The Secretary of Health and Human Services 
        shall establish standards for the licensing of persons 
        providing (or arranging for the provision of) home infusion 
        therapy services consistent with this subsection.
            (2) Supervision.--A person licensed under this section 
        shall only provide (or arrange for the provision of) home 
        infusion therapy services to an individual who is under the 
        care of a physician and under a plan established and 
        periodically reviewed by a physician.
            (3) Provider qualifications.--A person shall not be 
        licensed consistent with this section unless the person--
                    (A) has been determined to be capable of providing, 
                or arranging for the provision of, home infusion 
                therapy services;
                    (B) maintains clinical records on all individuals 
                for whom the person provides (or arranges for the 
                provision of) such services;
                    (C) adheres to written protocols and policies with 
                respect to the provision (or arrangement for the 
                provision) of services;
                    (D) makes services available (as needed) 7 days a 
                week on a 24-hour basis;
                    (E) coordinates all home infusion therapy services 
                with the patient's physician;
                    (F) conducts a quality assessment and assurance 
                program, including drug regimen review and coordination 
                of patient care;
                    (G) assures that only trained (or licensed if 
                necessary) personnel provide infusion products (and any 
                other service for which training is required to safely 
                provide the service);
                    (H) assumes responsibility for the quality of 
                services provided by others under arrangements with 
                such person;
                    (I) establishes appropriate protocols and explains 
                such protocols clearly to patients before the 
                initiation of a treatment plan; and
                    (J) meets such other requirements as the Secretary 
                may determine are necessary (A) to assure the safe and 
                effective provision of home infusion therapy services, 
                and (B) respecting the quality of the provision of such 
                services and the charges for such services.
        A protocol referred to in subparagraph (I) shall include a 
        provision for appropriate notification of individuals receiving 
        home infusion therapy services in the event of the cancellation 
        of the provision of those services.
            (4) Fee.--A person shall not be licensed consistent with 
        this section unless the person assures that charges for the 
        provision of home infusion therapy services by the person (or 
        under arrangements made by the person) shall not exceed such a 
        fee as the Secretary by regulation may establish to assure that 
        the charge for such services is reasonably related to the 
        services actually provided.
    (c) Enforcement.--Compliance with the requirements of subsection 
(a) shall be enforced under the Federal Trade Commission Act by the 
Secretary of Health and Human Services. A violation of any such 
requirement shall constitute an unfair or deceptive act or practice in 
commerce in violation of section 5(a) of the Federal Trade Commission 
Act and shall be subject to enforcement under section 5(b) of such Act 
irrespective of whether the person who committed such violation is 
engaged in commerce or meets any other jurisdictional test in such Act. 
The Secretary shall have such procedural, investigative, and 
enforcement powers in enforcing compliance with such requirements and 
may require the filing of reports, the production of documents, and the 
appearance of witnesses as though the applicable terms of such Act were 
part of this section.

SEC. 3. LIMITATION ON PHYSICIAN REFERRALS.

    (a) General Rule.--Except as provided in this section, if a 
physician (or an immediate family member of such physician) has a 
financial relationship with an entity described in section 1877(a)(2) 
of the Social Security Act, then the physician may not make a referral 
to the entity for the furnishing of home infusion therapy services.
    (b) Incorporation of Medicare Physician Ownership and Referral 
Provisions.--The provisions of subsections (b) through (h) of section 
1877 of the Social Security Act (other than subsections (f) and (g)(1)) 
shall apply with respect to subsection (a) of this section in the same 
manner as they apply to section 1877(a) of such Act. In applying the 
previous sentence, any reference to a ``designated health service'' is 
deemed to be a reference to home infusion therapy services.
    (c) Additional Exception for Compensation Arrangement for 
Management of Patient and Coordination of Care.--In applying subsection 
(b), in addition to the exceptions described in section 1877(e) of the 
Social Security Act, payment of reasonable compensation to a physician 
for the management of patient and coordination of care shall not be 
considered to be a compensation arrangement described in section 
1877(a)(2)(B) of such Act.
    (d) Treatment of Prescription as a Referral.--In applying 
subsection (b) and in addition to section 1877(h)(5) of the Social 
Security Act, the prescription of a drug to be administered through 
home infusion constitutes a ``referral'' by a ``referring physician''.

SEC. 4. HOME INFUSION THERAPY SERVICES DEFINED.

    For purposes of this Act, the term ``home infusion therapy 
services'' means the nursing, pharmacy, and related services, including 
medical supplies, intravenous fluids, delivery, and equipment, required 
for the provision of therapeutic agents to patients by parenteral 
administration, including intravenous, intra-arterial, subcutaneous, 
epidural, intrathecal, intramuscular, and peritoneal infusion, by an 
enteral feeding tube for the purpose of improving or maintaining an 
individual's health condition in the individual's residence.

SEC. 5. EFFECTIVE DATES.

    (a) Licensing Requirement.--
            (1) In general.--Except as provided in paragraph (2), 
        section 3(a) shall apply to home infusion therapy services 
        provided on or after the first day of the first month that 
        begins more than 90 days after the date of the enactment of 
        this Act, without regard to whether or not the Secretary of 
        Health and Human Services issues final regulations to carry out 
        such section have been promulgated by such date.
            (2) State legislation.--In the case of a State which the 
        Secretary of Health and Human Services determines requires 
        State legislation (other than legislation appropriating funds) 
        in order for the State to provide for the licensing required 
        under section 3(a), section 3(a) shall not apply in the State 
        for home infusion therapy services provided before the first 
        day of the first calendar quarter beginning after the close of 
        the first regular session of the State legislature that begins 
        after the date of the enactment of this Act. For purposes of 
        the previous sentence, in the case of a State that has a 2-year 
        legislative session, each year of such session shall be deemed 
        to be a separate regular session of the State legislature.
    (b) Limitation on Referrals.--Section 4 shall apply to referrals 
made after December 31, 1994.

                                 <all>
```