[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1579 Introduced in House (IH)]







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.
    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 1995''.

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

    (a) Requirement.--
            (1) License 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.
            (2) Licensing procedure.--No State shall license a person 
        to provide (or arrange for the provision of) home infusion 
        therapy services unless the State finds that the person meets 
        the standards for licensing established under this section.
            (3) Exception.--Paragraph (1) shall not apply in the case 
        of an individual providing home infusion therapy services 
        without compensation for himself or herself or for a family or 
        household member.
    (b) Standards.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this Act referred to as the ``Secretary'') 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;
                    (J) is certified to be a home health agency for 
                purposes of title XVIII of the Social Security Act or 
                meets the requirements to be so certified; and
                    (K) meets such other requirements as the Secretary 
                may determine are necessary (i) to assure the safe and 
                effective provision of home infusion therapy services, 
                and (ii) 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.
    (c) Enforcement.--
            (1) Providers.--Any person who provides (or arranges for 
        the provision of) home infusion therapy services in violation 
        of subsection (a)(1) is subject to a civil money penalty (in an 
        amount specified by the Secretary, but not to exceed $10,000) 
        for each such violation. The Secretary may file an action to 
        enjoin persons from violating subsection (a)(1).
            (2) States.--The Secretary shall establish a process for 
        determining whether or not a State is complying with the 
        requirement of subsection (a)(2). Before determining that a 
        State has not established a licensing system that complies with 
        such requirement, the Secretary shall provide the State with 
        notice and opportunity to respond and correct any deficiencies 
        identified by the Secretary.
    (d) Authorization of Appropriations; State Grants; Licensing 
Fees.--
            (1) Authorization of appropriations.--There are authorized 
        to be appropriated to the Secretary such amounts as may be 
        necessary for the Secretary to carry out this section.
            (2) Startup grants.--The Secretary is authorized to make 
        grants to States in order to enable those States initially to 
        establish the licensing system required under subsection 
        (a)(2).
            (3) Licensing fees.--Nothing in this Act shall be construed 
        as preventing a State from requiring payment of a fee from a 
        provider as a condition of licensing under subsection (a)(1) in 
        order to reimburse the State for the costs of operating the 
        licensing system provided under subsection (a)(2).

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) 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. STUDY OF MEDICARE IN-HOME COVERAGE OF CERTAIN INFUSION THERAPY 
              SERVICES.

    (a) In General.--The Secretary shall conduct a study of the 
feasibility and economic impact of covering under part B of title XVIII 
of the Social Security Act on an in-home basis those infusion therapy 
services that would otherwise be covered under part A of such title.
    (b) Report.--The Secretary shall submit to Congress, by not later 
than one year after the date of the enactment of this Act, a report on 
the study conducted under subsection (a). Such report shall include 
such recommendations respecting coverage of home infusion therapy 
services under part B of title XVIII of the Social Security Act as the 
Secretary deems appropriate.

SEC. 6. EFFECTIVE DATES.

    (a) Licensing Requirement.--
            (1) In general.--Except as provided in paragraph (2), 
        section 2(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 
        Services issues final regulations to carry out such section by 
        such date.
            (2) Exception where state legislation required.--In the 
        case of a State which the Secretary determines requires State 
        legislation (other than legislation appropriating funds) in 
        order for the State to provide for the licensing required under 
        section 2(a)(2), section 2(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 3 shall apply to referrals 
made after December 31, 1995.
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