[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3505 Introduced in Senate (IS)]







110th CONGRESS
  2d Session
                                S. 3505

  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

                           September 17, 2008

 Mrs. Lincoln (for herself, Ms. Snowe, and Mr. Isakson) 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 2008''.

SEC. 2. MEDICARE COVERAGE OF HOME INFUSION THERAPY.

    (a) In General.--Section 1861 of the Social Security Act (42 U.S.C. 
1395x), as amended by section 152(b) of the Medicare Improvements for 
Patients and Providers Act of 2008 (Public Law 110-275), is amended--
            (1) in subsection (s)(2)--
                    (A) by striking ``and'' at the end of subparagraph 
                (DD);
                    (B) by adding ``and'' at the end of subparagraph 
                (EE); and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(FF) home infusion therapy (as defined in subsection 
        (hhh)(1));''; and
            (2) by adding at the end the following new subsection:

                        ``Home Infusion Therapy

    ``(hhh)(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 
        (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 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:
    ``(n) 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(hhh)(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 quality and safety standards 
        developed under section 1861(hhh)(1) 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(hhh)(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 quality and safety 
        standards developed pursuant to this Act 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)), as amended by section 
        101(a)(2) of the Medicare Improvements for Patients and 
        Providers Act of 2008 (Public Law 110-275), is amended--
                    (A) by striking ``and'' before ``(W)''; and
                    (B) by inserting before the semicolon at the end 
                the following: ``, and (X) with respect to home 
                infusion therapy, the amounts paid shall be determined 
                under section 1834(n)''.
            (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)(1) of the Social Security Act 
(42 U.S.C. 1395w-102(e)(1)), as amended by section 182 of the Medicare 
Improvements for Patients and Providers Act of 2008 (Public Law 110-
275), 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 
after ``any dispensing fees for such drugs'' the following: ``, other 
than for an infusion drug''.

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

    (a) Objectives in Implementation.--The Secretary of Health and 
Human Services shall implement the Medicare home infusion therapy 
benefit under the amendments made by this Act in a manner that ensures 
that Medicare beneficiaries have timely and appropriate access to 
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 services 
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, MA-PD plans, and Medicare Advantage plans, and the 
        Secretary shall consider the use of consolidated claims 
        encompassing covered part D drugs and part B services, 
        supplies, and equipment under such part B to ensure the 
        efficient operation of this benefit;
            (2) any prior authorization or utilization review process 
        is expeditious, allowing Medicare beneficiaries meaningful 
        access to home infusion therapy;
            (3) medical necessity determinations for home infusion 
        therapy will be made by Medicare administrative contractors 
        under such part B and communicated to the appropriate 
        prescription drug plans and MA-PD plans 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 such 
home infusion therapy benefit and meeting the objectives specified in 
subsection (a), the Secretary shall establish an advisory panel 
comprised of qualified home infusion therapy providers and their 
representative organizations as well as representatives of the 
following to provide advice and recommendations:
            (1) Patient organizations.
            (2) Hospital discharge planners, care coordinators, or 
        social workers.
            (3) Prescription drug plan sponsors and Medicare Advantage 
        organizations.
    (c) Report.--Not later than January 1, 2011, and every 2 years 
thereafter, the Comptroller General of the United States shall submit a 
report to Congress on Medicare beneficiary access to home infusion 
therapy. Each such report shall specifically address whether the 
objectives specified in subsection (a) have been met and shall make 
recommendations to Congress and the Secretary on how to improve the 
benefit and better ensure that Medicare beneficiaries have timely and 
appropriate access to infusion therapy in their homes.

SEC. 5. EFFECTIVE DATE.

    The amendments made by this Act shall apply to home infusion 
therapy furnished on or after January 1, 2009.
                                 <all>