To amend title XVIII of the Social Security Act to provide for coverage of home infusion drug therapies under the Medicare Program.

Summary: Medicare Home Infusion Therapy Act of 2001 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to provide for coverage of home infusion drug therapy services.

SECTION 1. SHORT TITLE; PURPOSES.

    (a) Short Title.--This Act may be cited as the ``Medicare Home 
Infusion Therapy Act of 2001''.
    (b) Purpose.--The purposes of this Act are to ensure that medicare 
beneficiaries--
            (1) have the choice of receiving infusion drug therapies in 
        the home when clinically appropriate rather than in an 
        inpatient setting; and
            (2) are receiving high quality, safe, and efficient care 
        with respect to home infusion drug therapies.

SEC. 2. COVERAGE OF AND PAYMENT FOR HOME INFUSION DRUG THERAPY 
              SERVICES.

    (a) Coverage.--
            (1) In general.--Section 1861(s) of the Social Security Act 
        (42 U.S.C. 1395x(s)) is amended--
                    (A) in the second sentence, by redesignating 
                paragraphs (16) and (17) as clauses (i) and (ii); and
                    (B) in the first sentence--
                            (i) by striking ``and'' at the end of 
                        paragraph (14);
                            (ii) by striking the period at the end of 
                        paragraph (15) and inserting ``; and''; and
                            (iii) by adding after paragraph (15) the 
                        following new paragraph:
            ``(16) home infusion drug therapy services (as defined in 
        subsection (ww).''.
            (2) Conforming amendments.--Sections 1864(a) 1902(a)(9)(C), 
        and 1915(a)(1)(B)(ii)(I) of such Act (42 U.S.C. 1395aa(a), 
        1396a(a)(9)(C), and 1396n(a)(1)(B)(ii)(I)) are each amended by 
        striking ``paragraphs (16) and (17)'' each place it appears and 
        inserting ``clauses (i) and (ii) of the second sentence''.
    (b) Home Infusion Drug Therapy Defined.--Section 1861 of such Act 
(42 U.S.C. 1395x), as amended by sections 102 and 105 of the Medicare, 
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 
(114 Stat. 2763A-468, 471), as enacted into law by section 1(a)(6) of 
Public Law 106-554, is amended by adding at the end the following new 
subsection:

                 ``Home Infusion Drug Therapy Services

    ``(ww)(1) The term `home infusion drug therapy services' means--
            ``(A) pharmacy, nursing, and related items and services 
        (including medical supplies, intravenous fluids, drugs 
        described in section 1834(n), home delivery, equipment, and 
        other items and services the Secretary determines appropriate) 
        to administer infusion drug therapies to an individual safely 
        and effectively in the home in conformance with clinical 
        standards of care established by the Secretary;
            ``(B) that are furnished by a qualified supplier via an 
        intravenous, intra-arterial or intrathecal access device 
        inserted into the body; and
            ``(C) provided under a plan of care established and 
        periodically reviewed by a physician.
    ``(2) In paragraph (1)--
            ``(A) the term `home' means a place of residence used as an 
        individual's home (or a provider of services used as the 
        individual's home if the drug is administered during a period 
        of inpatient stay for which payment is not made to the provider 
        of services under part A); and
            ``(B) the term `qualified supplier' means any entity that 
        meets such requirements as the Secretary determines are 
        necessary to ensure the safe and effective provision of home 
        infusion drug therapy services.''.
    (c) Payment.--
            (1) Establishment of fee schedule.--Section 1834 of the 
        Social Security Act (42 U.S.C. 1395l), as amended by section 
        223(b) of the Medicare, Medicaid, and SCHIP Benefits 
        Improvement and Protection Act of 2000 (114 Stat. 2763A-487), 
        as enacted into law by section 1(a)(6) of Public Law  106-554, 
is amended by adding at the end the following new subsection:
    ``(n) Home Infusion Drug Therapy Services.--
            ``(1) Establishment of fee schedule.-- The Secretary shall 
        establish by regulation before the beginning of 2002 and each 
        succeeding year a fee schedule for home infusion drug therapy 
        services for which payment is made under this part. In so 
        doing, the Secretary shall ensure the adequacy of aggregate 
        payments for the drug and nondrug components of home infusion 
        drug therapy, consistent with the requirements of paragraphs 
        (2) and (3).
            ``(2) Requirements.--The Secretary shall ensure that the 
        coverage, reimbursement, and standards for covered home 
        infusion drug therapy services adequately reflect the various 
        components of care (including the services, drugs, supplies, 
        equipment, and related costs) necessary to ensure the safe and 
        effective provision of home infusion drug therapy. In so doing, 
        the Secretary shall--
                    ``(A) take into account the definitions, 
                requirements, and clinical standards commonly used for 
                home infusion drug therapy by private health plans and 
                accrediting organizations;
                    ``(B) ensure the adequacy of the aggregate payment 
                levels for home infusion drug therapy services, without 
                regard to whether payments for drug and nondrug 
                components are bundled or partially bundled by the 
                Secretary;
                    ``(C) ensure that sufficient numbers of 
                geographically distributed and qualified home infusion 
                drug therapy providers participate in the part B 
                program so that enrolled beneficiaries have meaningful 
                access to home infusion drug therapy services provided 
                in accordance with the established quality of care 
                standards; and
                    ``(D) consult with providers and trade associations 
                specializing in home infusion drug therapy.
            ``(3) Publication of list of covered home infusion drugs.--
        Not later than January 1, 2002 (and quarterly thereafter), the 
        Secretary shall publish a list of the drugs, and indications 
        for such drugs, that are covered home infusion drugs, with 
        respect to which home infusion drug therapy may be provided 
        under this title. This list shall include the following:
                    ``(A) All intravenous antibiotic drugs unless the 
                Secretary has determined for a specific drug and 
                indication that the drug cannot generally be 
                administered safely and effectively in a home setting.
                    ``(B) All infusion drug therapies requiring an 
                external infusion pump for safe and effective 
                administration that were, as of June 30, 2001, covered 
                by reason of 1861(s)(6).
                    ``(C) Parenterally administered blood-derived 
                products.
                    ``(D) Any other infusion drug for which the 
                Secretary has determined that, with respect to a 
                specific drug or the indication to which the drug is 
                applied, the drug can be administered safely and 
                effectively in the home (as defined in section 
                1861(ww)(2)(A).''.
            (2) Conforming amendments.--(A) Section 1833(a)(1) of such 
        Act (42 U.S.C. 1395l(1)), as amended by sections 105(c) and 
        223(c) of the Medicare, Medicaid, and SCHIP Benefits 
        Improvement and Protection Act of 2000 (114 Stat. 2763A-YYY472, 
        489), as enacted into law by section 1(a)(6) of Public Law 106-
        554, is amended--
                    (i) by striking ``and (U)'' and inserting ``(U)''; 
                and
                    (ii) by inserting before the semicolon at the end 
                the following: ``, and (V) with respect to home 
                infusion drug therapy services (as defined in section 
                1861(ww)(1)), the amounts paid shall be 80 percent of 
                the lesser of the actual charge or the amount 
                determined under the fee schedule established under 
                section 1834(n)''.
            (B) The first sentence of section 1862(a) of such Act (42 
        U.S.C. 1395y(a)) is amended--
                    (i) by striking ``or'' at the end of paragraph 
                (20);
                    (ii) by striking the period at the end of paragraph 
                (21) and inserting ``; or''; and
                    (iii) by inserting after paragraph (21) the 
                following new paragraph:
            ``(22) in the case of home infusion drug therapy services 
        under section 1861(ww)--
                    ``(A) that are not furnished in the home (as 
                defined in paragraph (2)(A) of that section;
                    ``(B) that do not meet the standards of clinical 
                care established by the Secretary;
                    ``(C) that include drugs not listed under section 
                1834(n)(3);
                    ``(D) that are items and services other than items 
                and services that Secretary determines appropriate 
                under that section; and
                    ``(E) for which payment may be made under this 
                title other than under section 1833(a)(1)(V).''.
    (d) Exclusion From Definition of Durable Medical Equipment.--
Section 1861(n) of such Act (42 U.S.C. 1395x(n)) is amended by adding 
at the end the following: ``Such term does not include home infusion 
drug therapy services (as defined in subsection (ww)).''.
    (e) Effective Date.--The amendments made by this section shall 
apply to items and services furnished on or after January 1, 2002. The 
Secretary shall publish a rule under this subsection in the Federal 
Register by not later than the January 1, 2002. Such rule shall be 
effective and final immediately on an interim basis, but is subject to 
change and revision after public notice and opportunity for a period 
(of not less than 60 days) for public comment.