[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1203 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                S. 1203

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 15, 2011

Ms. Snowe (for herself, Mr. Kerry, Mr. Isakson, Ms. Klobuchar, and Mr. 
    Inouye) introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


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

    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 ``Medicare Home Infusion Therapy 
Coverage Act of 2011''.

SEC. 2. MEDICARE COVERAGE OF HOME INFUSION THERAPY.

    (a) In General.--Section 1861 of the Social Security Act (42 U.S.C. 
1395x) is amended--
            (1) in subsection (s)(2)--
                    (A) by striking ``and'' at the end of subparagraph 
                (EE);
                    (B) by adding ``and'' at the end of subparagraph 
                (FF); and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(GG) home infusion therapy (as defined in subsection 
        (iii)(1));''; and
            (2) by adding at the end the following new subsection:

                        ``Home Infusion Therapy

    ``(iii)(1) The term `home infusion therapy' means the following 
items and services furnished to an individual, who is under the care of 
a physician, which are provided by a qualified home infusion therapy 
provider under a plan (for furnishing such items and services to such 
individual) established and periodically reviewed by a physician, which 
items and services are provided in an integrated manner in the 
individual's home in conformance with uniform standards of care 
established by the Secretary (after taking into account the standards 
commonly used for home infusion therapy by Medicare Advantage plans and 
in the private sector and after consultation with all interested 
stakeholders) and in coordination with the provision of covered 
infusion drugs under part D:
            ``(A) Professional services other than nursing services 
        provided in accordance with the plan (including administrative, 
        compounding, dispensing, distribution, clinical monitoring and 
        care coordination services) and all necessary supplies and 
        equipment (including medical supplies such as sterile tubing 
        and infusion pumps, and other items and services the Secretary 
        determines appropriate) to administer infusion drug therapies 
        to an individual safely and effectively in the home.
            ``(B) Nursing services provided in accordance with the 
        plan, directly by a qualified home infusion therapy provider or 
        under arrangements with an accredited homecare organization, in 
        connection with such infusion, except that such term does not 
        include nursing services to the extent they are covered as home 
        health services.
    ``(2) For purposes of paragraph (1):
            ``(A) The term `home' means a place of residence used as an 
        individual's home and includes such other alternate settings as 
        the Secretary determines.
            ``(B) The term `qualified home infusion therapy provider' 
        means any pharmacy, physician, or other provider licensed by 
        the State in which the pharmacy, physician, or provider resides 
        or provides services, whose State authorized scope of practice 
        includes dispensing authority and that--
                    ``(i) has expertise in the preparation of 
                parenteral medications in compliance with enforceable 
                standards of the U.S. Pharmacopoeia and other 
                nationally recognized standards that regulate 
                preparation of parenteral medications as determined by 
                the Secretary and meets such standards;
                    ``(ii) provides infusion therapy to patients with 
                acute or chronic conditions requiring parenteral 
                administration of drugs and biologicals administered 
                through catheters or needles, or both, in a home; and
                    ``(iii) meets such other uniform requirements as 
                the Secretary determines are necessary to ensure the 
                safe and effective provision and administration of home 
                infusion therapy on a 7-day-a-week, 24-hour basis 
                (taking into account the standards of care for home 
                infusion therapy established by Medicare Advantage 
                plans and in the private sector), and the efficient 
                administration of the home infusion therapy benefit.
        A qualified home infusion therapy provider may subcontract with 
        a pharmacy, physician, provider, or supplier to meet the 
        requirements of this subsection.''.
    (b) Payment for Home Infusion Therapy.--Section 1834 of the Social 
Security Act (42 U.S.C. 1395m) is amended by adding at the end the 
following new subsection:
    ``(p) Payment for Home Infusion Therapy.--The payment amount under 
this part for home infusion therapy is determined as follows:
            ``(1) In general.--The Secretary shall determine a per diem 
        schedule for payment for the professional services, supplies, 
        and equipment described in section 1861(iii)(1)(A) that 
        reflects the reasonable costs which must be incurred by 
        efficiently and economically operated qualified home infusion 
        therapy providers to provide such services, supplies, and 
        equipment in conformity with applicable State and Federal laws, 
        regulations, and the uniform standards of care and other 
        uniform requirements established by the Secretary under section 
        1861(iii) and to assure that Medicare beneficiaries have 
        reasonable access to such therapy. The Secretary shall update 
        such schedule from year to year by the percentage increase in 
        the consumer price index for all urban consumers (United States 
        city average) for the 12-month period ending with June of the 
        preceding year.
            ``(2) Nursing services.--The Secretary shall develop a 
        methodology for the separate payment for nursing services 
        described in section 1861(iii)(1)(B) provided in accordance 
        with the plan under such section which reflects the reasonable 
        costs incurred in the provision of nursing services in 
        connection with infusion therapy in conformity with State and 
        Federal laws, regulations, and the uniform standards of care 
        and other uniform requirements established by the Secretary 
        under section 1861(iii) and to assure that Medicare 
        beneficiaries have reasonable access to nursing services for 
        infusion therapy. The Secretary shall update such schedule from 
        year to year by the percentage increase in the consumer price 
        index for all urban consumers (United States city average) for 
        the 12-month period ending with June of the preceding year.''.
    (c) Conforming Amendments.--
            (1) Payment reference.--Section 1833(a)(1) of the Social 
        Security Act (42 U.S.C. 13951(a)(1)) is amended--
                    (A) by striking ``and'' before ``(Z)''; and
                    (B) by inserting before the semicolon at the end 
                the following: ``, and (AA) with respect to home 
                infusion therapy, the amounts paid shall be determined 
                under section 1834(p)''.
            (2) Direct payment.--The first sentence of section 
        1842(b)(6) of such Act (42 U.S.C. 1395u(b)(6)) is amended--
                    (A) by striking ``and'' before ``(H)''; and
                    (B) by inserting before the period at the end the 
                following: ``, and (I) in the case of home infusion 
                therapy, payment shall be made to the qualified home 
                infusion therapy provider''.
            (3) Exclusion from durable medical equipment and home 
        health services.--Section 1861 of such Act (42 U.S.C. 1395x) is 
        amended--
                    (A) in subsection (m)(5), by inserting ``and 
                supplies used in the provision of home infusion 
                therapy'' after ``excluding other drugs and 
                biologicals''; and
                    (B) in subsection (n), by adding at the end the 
                following: ``Such term does not include home infusion 
                therapy, other than equipment and supplies used in the 
                provision of insulin.''.
            (4) Application of accreditation provisions.--The 
        provisions of section 1865(b) of the Social Security Act (42 
        U.S.C. 1395bb(b)) apply to the accreditation of qualified home 
        infusion therapy providers in the manner they apply to other 
        suppliers.

SEC. 3. MEDICARE COVERAGE OF HOME INFUSION DRUGS.

    (a) In General.--Section 1860D-2(e) of the Social Security Act (42 
U.S.C. 1395w-102(e)) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``or'' at the end of subparagraph 
                (A);
                    (B) by striking the comma at the end of 
                subparagraph (B) and inserting ``; or''; and
                    (C) by inserting before the flush matter following 
                subparagraph (B) the following new subparagraph:
                    ``(C) an infusion drug (as defined in paragraph 
                (5)),''; and
            (2) by adding at the end the following new paragraph:
            ``(5) Infusion drug defined.--For purposes of this part, 
        the term `infusion drug' means a parenteral drug or biological 
        administered via an intravenous, intraspinal, intra-arterial, 
        intrathecal, epidural, subcutaneous, or intramuscular access 
        device inserted into the body, and includes a drug used for 
        catheter maintenance and declotting, a drug contained in a 
        device, vitamins, intravenous solutions, diluents and minerals, 
        and other components used in the provision of home infusion 
        therapy.''.
    (b) Infusion Drug Formularies.--For the first 2 years after the 
effective date of this Act, notwithstanding any other provision of law, 
prescription drug plans and MA-PD plans under title XVIII of the Social 
Security Act shall maintain open formularies for infusion drugs (as 
defined in section 1860D-2(e)(5) of such Act, as added by subsection 
(a)). The Secretary of Health and Human Services shall request the 
United States Pharmacopeia to develop, in consultation with 
representatives of qualified home infusion therapy providers and other 
interested stakeholders, a model formulary approach for home infusion 
drugs for use by such plans after such 2-year period.
    (c) Part D Dispensing Fees.--Section 1860D-2(d)(1)(B) of the Social 
Security Act (42 U.S.C. 1395w-102(d)(1)(B)) is amended by inserting ``, 
other than for an infusion drug'' after ``any dispensing fees for such 
drugs''.

SEC. 4. ENSURING BENEFICIARY ACCESS TO HOME INFUSION THERAPY.

    (a) Objectives in Implementation.--The Secretary shall implement 
the Medicare home infusion therapy benefit in a manner that ensures 
that Medicare beneficiaries have timely and appropriate access to home 
infusion therapy in their homes and that there is rapid and seamless 
coordination between drug coverage under part D of title XVIII of the 
Social Security Act and coverage for home infusion therapy under part B 
of such title. Specifically, the Secretary shall ensure that--
            (1) the benefit is practical and workable with minimal 
        administrative burden for beneficiaries, qualified home 
        infusion therapy providers, physicians, prescription drug 
        plans, and MA plans (including MA-PD plans), and the Secretary 
        shall consider the use of consolidated claims encompassing 
        covered part D drugs and home infusion therapy to ensure the 
        efficient operation of this benefit;
            (2) any prior authorization or utilization review process 
        under such benefit is expeditious, allowing Medicare 
        beneficiaries meaningful access to home infusion therapy;
            (3) medical necessity determinations for home infusion 
        therapy will be made--
                    (A) except as provided in subparagraph (B), by 
                Medicare administrative contractors under such part B 
                and communicated to the appropriate prescription drug 
                plans; or
                    (B) in the case of an individual enrolled in a 
                Medicare Advantage plan, by the MA organization 
                offering the plan,
        and an individual may be initially qualified for coverage for 
        such benefit for a 90-day period and subsequent 90-day periods 
        thereafter;
            (4) the benefit is modeled on current private sector 
        coverage and coding for home infusion therapy; and
            (5) prescription drug plans and MA-PD plans structure their 
        formularies, utilization review protocols, and policies in a 
        manner that ensures that Medicare beneficiaries have timely and 
        appropriate access to infusion therapy in their homes.
    (b) Home Infusion Therapy Advisory Panel.--In implementing the 
Medicare home infusion therapy benefit and meeting the objectives 
specified in subsection (a), the Secretary shall establish an advisory 
panel to provide advice and recommendations. Such panel shall--
            (1) be comprised primarily of qualified home infusion 
        therapy providers and their representative organizations; and
            (2) include representatives of--
                    (A) patient organizations;
                    (B) hospital discharge planners, care coordinators, 
                or social workers; and
                    (C) PDP sponsors and MA organizations.
    (c) Report.--Not later than January 1, 2014, and every 2 years 
thereafter, the Comptroller General shall submit to Congress and the 
Secretary a report on Medicare beneficiary access to home infusion 
therapy. Each report submitted under the preceding sentence shall 
specifically address whether the objectives specified in subsection (a) 
have been met and include recommendations for Congress and the 
Secretary on how to improve the Medicare home infusion therapy benefit 
and better ensure that Medicare beneficiaries have timely and 
appropriate access to infusion therapy in their homes, together with 
recommendations for such legislation and administrative action as the 
Comptroller General determines appropriate.
    (d) Definitions.--In this section:
            (1) Comptroller general.--The term ``Comptroller General'' 
        means the Comptroller General of the United States.
            (2) Home infusion therapy.--The term ``home infusion 
        therapy'' has the meaning given such term in section 1861(iii) 
        of the Social Security Act, as added by section 2(a).
            (3) MA organization.--The term ``MA organization'' has the 
        meaning given such term in section 1859(a)(1) of such Act (42 
        U.S.C. 1395w-28(a)(1)).
            (4) MA plan.--The term ``MA plan'' has the meaning given 
        such term in section 1860D-1(a)(3)(B) of such Act (42 U.S.C. 
        1395w-101(a)(3)(B)).
            (5) MA-PD plan.--The term ``MA-PD plan'' has the meaning 
        given such term in section 1860D-1(a)(3)(C) of such Act (42 
        U.S.C. 1395w-101(a)(3)(C)).
            (6) Medicare home infusion therapy benefit.--The term 
        ``Medicare home infusion therapy benefit'' means items and 
        services furnished under the provisions of and amendments made 
        by this Act.
            (7) PDP sponsor.--The term ``PDP sponsor'' has the meaning 
        given such term in section 1860D-41(13) of the Social Security 
        Act (42 U.S.C. 1395w-151(13)).
            (8) Prescription drug plan.--The term ``prescription drug 
        plan'' has the meaning given such term in section 1860D-41(14) 
        of such Act (42 U.S.C. 1395w-151(14)).
            (9) Qualified home infusion therapy provider.--The term 
        ``qualified home infusion therapy provider'' has the meaning 
        given such term in paragraph (2)(B) of such section 1861(iii).
            (10) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

SEC. 5. EFFECTIVE DATE.

    The provisions of and amendments made by this Act shall apply to 
home infusion therapy furnished on or after January 1, 2012.
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