[Congressional Record Volume 155, Number 9 (Thursday, January 15, 2009)]
[Senate]
[Pages S612-S614]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. LINCOLN (for herself, Ms. Snowe, and Mr. Isakson):
  S. 254. A bill to amend title XVIII of the Social Security Act to 
provide for the coverage of home infusion therapy under the Medicare 
Program; to the Committee on Finance.
  Ms. SNOWE. Mr. President, today I am pleased to join my colleague, 
Senator Lincoln of Arkansas, to introduce the Medicare Home Infusion 
Coverage Act. As we do so, we recognize that Medicare has serious 
fiscal challenges. Currently, the Part A, Hospital, Trust Fund faces 
insolvency in 2019, when expenditures will exceed projected 
contributions and require additional taxpayer support to maintain the 
care required by our seniors and so many disabled Americans. At the 
same time, today Medicare beneficiaries struggle under the burden of 
paying nearly half of their health care costs. So the legislation we 
are re-introducing is vital to addressing the fiscal issues affecting 
Medicare.
  Many serious conditions--including some cancers and drug-resistant 
infections--require the use of infusion therapy. Such treatment 
involves the administration of medication directly into the bloodstream 
via a needle or catheter. Specialized equipment, supplies, and 
professional services--such as sterile drug compounding, care 
coordination, and patient education and monitoring--are components of 
such therapy. Infusion treatment is an extensive medical treatment 
often lasting for several hours per day over a 6-to-8 week period.
  The unfortunate fact is that under current Medicare rules, patients 
requiring infusion therapy must either bear that cost themselves or 
endure costly and unnecessary hospitalization in order to receive 
coverage--raising costs for both beneficiaries and Medicare alike. 
Current Medicare regulations authorize payment for infusion drugs, but 
do not pay for the services, equipment, and supplies necessary to 
safely provide infusion therapy in the home. Not surprisingly, even 
though home infusion therapy may cost as little as $100 a day, too few 
seniors can bear that cost.
  The result is that patients are excessively hospitalized, producing 
costs of treatment as much as 10-20 times higher than treatment in the 
home. The process may even place the patient's health in jeopardy 
because unnecessary hospitalization places individuals at risk of 
exposure to a health care-acquired infection--which may be drug 
resistant and life-threatening.
  Private health plans have long understood that home infusion therapy 
is not only less costly, but safer as well. Thus, private insurance 
coverage for home infusion therapy is common. Private plans also 
recognize that patients benefit from avoiding hospitalization. At home 
they have a familiar, comfortable environment with their family 
conveniently at hand--no small concerns when fighting a serious 
illness.
  It is clear we must change the status quo, and achieve safer, more 
cost-effective treatment. By extending coverage of infusion therapy to 
the home, we will correct this inappropriate and unnecessary gap in 
Medicare coverage and take a significant step in reducing Medicare 
costs. This legislation offers an alternative to allowing our Medicare 
beneficiaries to be overcome with health care costs that are rising 
faster than inflation by reforming care delivery to emphasize high 
quality, lower cost services.
  I hope my colleagues will join us in support of this legislation so 
we may further the goals of improving patient safety and reducing our 
escalating health care costs.
  Mr. President, I ask unanimous consent that the text of the bill to 
be printed in the Record.

[[Page S613]]

  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 254

       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 2009''.

     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 
     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:
       ``(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--

[[Page S614]]

       (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--
       (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) 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 to provide advice and recommendations. Such 
     panel shall--
       (1) be comprised primarily of qualified home infusion 
     therapy providers and their representative organizations;
       (2) also include representatives of the following:
       (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, 2012, 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, 2010.
                                 ______