[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5435 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 5435

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 10, 2014

  Mr. Engel (for himself, Mr. Tiberi, Mr. Larson of Connecticut, Mr. 
Harper, Mr. Meehan, Ms. Pingree of Maine, and Mr. Peterson) introduced 
 the following bill; which was referred to the Committee on Energy and 
  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 amend title XVIII of the Social Security Act to provide for the 
   coverage of home as a site of care for 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 Site of Care 
Act of 2014''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) The Medicare fee-for-service program covers infusion 
        therapy in the hospital, skilled nursing facility, physician 
        office, and hospital outpatient department, but does not cover 
        the full range of services for the provision of infusion 
        therapies in a patient's home.
            (2) The Medicare program is presently the only major health 
        care payer in the United States that does not provide 
        comprehensive coverage of home infusion therapy.
            (3) As a result of the Medicare program not providing for 
        comprehensive coverage of home infusion therapy, many Medicare 
        beneficiaries are unable to obtain infusion therapy in the most 
        cost-effective and convenient setting of their home, and 
        physicians are deprived of the ability to select the best site 
        of care for their patients.
            (4) The Medicare program is paying for institutional care 
        for the provision of infusion therapy in many instances when 
        such institutional care could be avoided if the Medicare 
        program provided coverage for home infusion therapy.
            (5) The Government Accountability Office found in a 2010 
        report that home infusion therapy is utilized widely by private 
        payers providing health insurance coverage for individuals 
        enrolled under such coverage and that such private payers 
        generally are satisfied with the quality of care and the 
        savings they achieve through avoided institutionalizations.
            (6) A recent study has reported a potential savings for 
        Medicare if infusion therapies were covered in the home site of 
        care.

SEC. 3. 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 inserting ``and'' at the end of subparagraph 
                (FF); and
                    (C) by inserting 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 items and 
services described in paragraph (2) furnished to an individual, who is 
under the care of a physician, which are provided by a qualified home 
infusion therapy supplier 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 and in coordination with the 
provision of covered infusion drugs under part D. The Secretary shall 
establish such standards 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.
    ``(2) The items and services described in this paragraph are the 
following:
            ``(A) Professional services, including nursing services 
        (other than nursing services covered as home health 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).
            ``(B) Other items and services the Secretary determines 
        appropriate to administer infusion drug therapies to an 
        individual safely and effectively in the home.
    ``(3) For purposes of this subsection:
            ``(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 supplier' 
        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 United States 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.
    ``(4) A qualified home infusion therapy supplier may subcontract 
with a pharmacy, physician, provider, or supplier to meet the 
requirements of paragraph (3)(B).''.
    (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.--
            ``(1) In general.--The Secretary shall determine a per diem 
        schedule for payment for the professional services (including 
        nursing services), supplies, and equipment described in section 
        1861(iii)(2)(A) for each infusion therapy type that reflects 
        the reasonable costs which must be incurred by efficiently and 
        economically operated qualified home infusion therapy suppliers 
        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(iii)(1) and to assure that Medicare beneficiaries have 
        reasonable access to such therapy.
            ``(2) Considerations.--In developing the per diem schedule 
        under this subsection, the Secretary shall consider recent 
        credible studies about the costs of providing infusion therapy 
        in the home, consult with home infusion therapy suppliers, 
        consider payment amounts established by Medicare Advantage 
        plans and private payers for home infusion therapy, and, if 
        necessary, conduct a statistically valid national market 
        analysis involving the costs of administering infusion drugs 
        and of providing professional services necessary for the drugs' 
        administration.
            ``(3) Annual updates.--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. The Secretary may modify the per diem schedule 
        with respect to beneficiaries who qualify for home infusion 
        therapy services under section 1861(iii)(1) but who receive 
        nursing services as home health services.''.
    (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 the Social Security 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 supplier''.
            (3) Exclusion from durable medical equipment and home 
        health services.--Section 1861 of the Social Security Act (42 
        U.S.C. 1395x) is amended--
                    (A) in subsection (m)(5)--
                            (i) by striking ``and'' before ``durable 
                        medical equipment'' and inserting a comma; and
                            (ii) by inserting before the semicolon at 
                        the end the following: ``, 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(a) of the Social Security Act (42 
        U.S.C. 1395bb(a)) apply to the accreditation of qualified home 
        infusion therapy suppliers in the same way as they apply to 
        other suppliers.

SEC. 4. MEDICARE COVERAGE OF HOME INFUSION DRUGS.

    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 after 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 or injection, and may include a drug used for catheter 
        maintenance and declotting, a drug contained in a device, 
        additives including but not limited to vitamins, minerals, 
        solutions, and diluents, and other components used in the 
        provision of home infusion therapy.''.

SEC. 5. 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 to avoid the filing of duplicative or 
otherwise improper claims. Specifically, the Secretary shall ensure 
that--
            (1) the benefit is practical and workable with minimal 
        administrative burden for beneficiaries, qualified home 
        infusion therapy suppliers, 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--
                    (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 Medicare Advantage 
                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) except as otherwise provided in this section, 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) Report.--Not later than January 1, 2018, the Comptroller 
General of the United States shall submit a report to Congress on 
Medicare beneficiary access to home infusion therapy. Such report shall 
specifically address whether the objectives specified in subsection (a) 
have been met and shall make recommendations to Congress and the 
Secretary of Health and Human Services on how to improve the benefit 
and better ensure that Medicare beneficiaries have timely and 
appropriate access to infusion therapy in their homes.

SEC. 6. EFFECTIVE DATE.

    The amendments made by this Act shall apply to home infusion 
therapy furnished on or after January 1, 2015.
                                 <all>