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H.R.2195 - Medicare Home Infusion Therapy Coverage Act of 2011
To amend title XVIII of the Social Security Act to provide for the coverage of home infusion therapy under the Medicare Program.
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Mr. ENGEL (for himself, Mr. MURPHY of Pennsylvania, and Ms. BALDWIN) 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 concernedCommentsClose CommentsPermalink
SECTION 1. SHORT TITLE.
SEC. 2. FINDINGS.
(2) 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 homes.CommentsClose CommentsPermalink
(3) 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.CommentsClose CommentsPermalink
(4) The Government Accountability Office found in a 2010 report that home infusion therapy is utilized widely by private payors providing health insurance coverage for individuals enrolled under such coverage and that such private payors generally are satisfied with the quality of care and the savings they achieve through avoided institutionalizations.CommentsClose CommentsPermalink
SEC. 3. MEDICARE COVERAGE OF HOME INFUSION THERAPY.
‘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:CommentsClose CommentsPermalink
‘(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.CommentsClose CommentsPermalink
‘(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.CommentsClose CommentsPermalink
‘(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--CommentsClose CommentsPermalink
‘(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;CommentsClose CommentsPermalink
‘(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; andCommentsClose CommentsPermalink
‘(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.CommentsClose CommentsPermalink
‘(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 quality and safety standards developed under section 1861(iii)(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.CommentsClose CommentsPermalink
‘(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.’.CommentsClose CommentsPermalink
(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)’.CommentsClose CommentsPermalink
(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’.CommentsClose CommentsPermalink
(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.’.CommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
SEC. 4. MEDICARE COVERAGE OF HOME INFUSION DRUGS.
‘(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.’.CommentsClose CommentsPermalink
(b) Infusion Drug Formularies- For the first 2 years after the date of the enactment 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.CommentsClose CommentsPermalink
(c) Part D Dispensing Fees- Section 1860D-2(d)(1)(B) of the Social Security Act (
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. Specifically, the Secretary shall ensure that--CommentsClose CommentsPermalink
(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;CommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
(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 to provide advice and recommendations. Such panel shall--CommentsClose CommentsPermalink
(c) Report- Not later than January 1, 2014, 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.CommentsClose CommentsPermalink