text: SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
  
      (a) Short Title.--This Act may be cited as the ``Medicare Patient 
  IVIG Access Act of 2009''.
      (b) Table of Contents.--The table of contents of this Act is as 
  follows:
  
  Sec. 1. Short title; table of contents.
  Sec. 2. Findings.
  Sec. 3. Medicare payment for intravenous immune globulins (IVIG).
  Sec. 4. Coverage and payment of intravenous immune globulin in the 
                              home.
  Sec. 5. Collection of data and review of complexity codes for physician 
                              administration of IVIG.
  Sec. 6. Reports.
  Sec. 7. Offset.
  
  SEC. 2. FINDINGS.
  
      (a) Findings.--Congress finds the following:
              (1) The 2001 report of the Medicare Payment Advisory 
          Commission to Congress states that ``to help ensure 
          beneficiaries' access to high-quality care, Medicare payments 
          should correspond to the cost efficient providers incur in 
          furnishing this care''. Payments that do not meet this 
          objective may create barriers to access.
              (2) Intravenous immune globulin (IVIG) is a human blood 
          plasma derived product, which over the past 25 years has become 
          an invaluable therapy for many chronic conditions and 
          illnesses, including primary immunodeficiency diseases, 
          autoimmune, and neurological disorders. For many of these 
          disorders, IVIG is the most effective and viable treatment 
          available, and has dramatically improved the quality of life 
          for persons with these conditions and has become a life-saving 
          therapy for many.
              (3) The Food and Drug Administration (FDA) recognizes each 
          IVIG brand as a unique biologic. The differences in basic 
          fractionation and the addition of various modifications for 
          further purification, stabilization, and virus inactivation/
          removal yield clearly different biological products. As a 
          result, IVIG therapies are not interchangeable, with patient 
          tolerance differing from one IVIG brand to another.
              (4) The report of the Office of the Assistant Secretary for 
          Planning and Evaluation (ASPE), Department of Health and Human 
          Services (DHHS), ``Analysis of Supply, Distribution, Demand, 
          and Access Issues Associated with Immune Globulin Intravenous 
          (IGIV)'', issued in May 2007, found that IVIG manufacturing is 
          complex and requires substantial upfront cash outlay and 
          planning and takes between 7 and 12 months from plasma 
          collection at donor centers to FDA lot release.
              (5) The Medicare Prescription Drug, Improvement, and 
          Modernization Act of 2003 changed Medicare's reimbursement 
          methodology for IVIG from average wholesale price (AWP) to 
          average sales price plus 6 percent (ASP+6), effective January 
          1, 2005, for physicians, and January 1, 2006, for hospital 
          outpatient departments, thereby reducing reimbursement rates 
          paid to these providers of IVIG on behalf of Medicare 
          beneficiaries.
              (6) An Office of the Inspector General (OIG) April 2007 
          report, Intravenous Immune Globulin: Medicare Payment and 
          Availability, found that Medicare reimbursement for IVIG was 
          inadequate to cover the cost many providers must pay for the 
          product. During the third quarter of 2006, 44 percent of IVIG 
          sales to hospitals and 41 percent of sales to physicians by the 
          three largest distributors occurred at prices above Medicare 
          payment amounts.
              (7) The ASPE report notes that after the new reimbursement 
          rules for physicians were instituted in 2005, 42 percent of 
          Medicare beneficiaries who had received their IVIG treatment in 
          their physician's office at the end of 2004 were shifted to the 
          hospital outpatient setting by the beginning of 2006. This 
          shift in site of care has resulted in lack of continuity of 
          care and adverse impact on health outcomes and quality of life.
              (8) The OIG also reported that 61 percent of responding 
          physicians indicated that they had sent patients to hospitals 
          for IVIG treatment, largely because of their inability to 
          purchase IVIG at prices below the Medicare payment amounts. In 
          addition, OIG found that some physicians had stopped providing 
          IVIG to Medicare beneficiaries altogether.
              (9) The OIG's 2007 report concluded that whatever 
          improvement some providers saw in the relationship of Medicare 
          reimbursement for IVIG to prices paid during the first three 
          quarters of 2006 would be eroded if manufacturers were to 
          increase prices for IVIG in the future.
              (10) The Centers for Medicare & Medicaid Services, in 
          recognition of dislocations experienced by patients and 
          providers in obtaining IVIG since the change to the ASP+6 
          reimbursement methodology, has provided during 2006 and 2007 a 
          temporary additional payment for IVIG preadministration-related 
          services to compensate physicians and hospital outpatient 
          departments for the extra resources they have had to expend in 
          locating and obtaining appropriate IVIG products and in 
          scheduling patient infusions.
              (11) The Medicare Modernization Act of 2003 (MMA) 
          established an IVIG home infusion benefit for persons with 
          primary immunodeficiency disease (PIDD), paying only for IVIG 
          and specifically excluding coverage of items and services 
          related to administration of the product.
              (12) The ASPE report, Analysis of Supply, Distribution, 
          Demand, and Access Issues Associated with Immune Globulin 
          Intravenous (IGIV), found that Medicare's IVIG home infusion 
          benefit is not designed to reimburse for more than the cost of 
          IVIG and does not cover the cost of infusion services (for 
          example, nursing and clinical services and supplies) in the 
          home. As a consequence, the report found that home infusion 
          providers generally do not accept new PIDD patients with only 
          Medicare coverage. These limitations in service are caused by 
          health care providers--
                      (A) not being able to acquire IVIG at prices at or 
                  below the Medicare part B reimbursement level; and
                      (B) not being reimbursed for the infusion services 
                  provided by a nurse.
              (13) Physicians administering IVIG to Medicare 
          beneficiaries are reimbursed at the same low complexity level 
          as the administration of antibiotics. However the 
          administration of IVIG requires special preparation and 
          handling, involves significant patient risk, and prolonged 
          nursing time to monitor the patient during infusion.
  
  SEC. 3. MEDICARE PAYMENT FOR INTRAVENOUS IMMUNE GLOBULINS (IVIG).
  
      (a) In General.--Section 1842(o) of the Social Security Act (42 
  U.S.C. 1395u(o)) is amended--
              (1) in paragraph (1)(E)(ii), by inserting before the period 
          the following: ``, plus an additional amount (if applicable) 
          under paragraph (7)'';
              (2) in paragraph (7), by striking ``(6)'' and inserting 
          ``(7)'' and by redesignating it as paragraph (8); and
              (3) by inserting after paragraph (6) the following new 
          paragraph:
              ``(7)(A) Not later than 6 months after the date of the 
          enactment of the Medicare Patient IVIG Access Act of 2009, the 
          Secretary shall--
                      ``(i) collect data on the differences, if any, 
                  between payments to physicians for immune globulins 
                  under paragraph (1)(E)(ii) and costs incurred by 
                  physicians for furnishing these products; and
                      ``(ii) review available data, including survey data 
                  presented by members of the IVIG community and pricing 
                  data collected by the Federal Government, on the access 
                  of individuals eligible for services under this part to 
                  immune globulins.
              ``(B) Upon completion of the review and collection of data 
          under subparagraph (A), and not later than 7 months after the 
          date of the enactment of this paragraph, the Secretary shall 
          provide, if appropriate, to physicians furnishing immune 
          globulins, a payment, in addition to the payment provided for 
          in paragraph (1)(E)(ii), for all items related to the 
          furnishing of immune globulins, in an amount that the Secretary 
          determines to be appropriate. Such payment shall continue for a 
          period of 2 years beginning on the date such additional payment 
          is first provided under this subparagraph.''.
      (b) As Part of Hospital Outpatient Services.--Section 1833(t)(14) 
  of such Act (42 U.S.C. 1395l(t)(14)) is amended--
              (1) in subparagraph (A)(iii), in the matter preceding 
          subclause (I), by striking ``subparagraph (E)'' and inserting 
          ``subparagraphs (E) and (I)''; and
              (2) by adding at the end the following new subparagraph:
                      ``(I) Additional payment for immune globulins.--
                              ``(i) Data collection and review.--Not 
                          later than 6 months after the date of the 
                          enactment of the Medicare Patient IVIG Access 
                          Act of 2009, the Secretary shall--
                                      ``(I) review available data, 
                                  including survey data presented by 
                                  members of the IVIG community and 
                                  pricing data collected by the Federal 
                                  Government, on the access of 
                                  individuals eligible for services under 
                                  this part to immune globulins; and
                                      ``(II) collect data on the 
                                  differences, if any, between payments 
                                  for immune globulins under subparagraph 
                                  (A)(iii) and costs incurred for 
                                  furnishing these products.
                              ``(ii) Additional payment authority.--Upon 
                          completion of the review and collection of data 
                          under clause (i), and not later than 7 months 
                          after the date of the enactment of this 
                          subparagraph, the Secretary shall provide, if 
                          appropriate, to hospitals furnishing immune 
                          globulins as part of a covered OPD service, a 
                          payment, in addition to the payment provided 
                          for under subparagraph (A)(iii), for all items 
                          related to the furnishing of immune globulins, 
                          in an amount that the Secretary determines to 
                          be appropriate. Such payment shall continue for 
                          a period of 2 years beginning on the date such 
                          additional payment is first provided under this 
                          clause.''.
  
  SEC. 4. COVERAGE AND PAYMENT OF INTRAVENOUS IMMUNE GLOBULIN IN THE 
                HOME.
  
      (a) Including Coverage of Administration.--Section 1861 of the 
  Social Security Act (42 U.S.C. 1395x) is amended--
              (1) in subsection (s)(2)(Z), by inserting ``and items and 
          services related to the administration of intravenous immune 
          globulin'' after ``globulin''; and
              (2) in subsection (zz), by striking ``but not including 
          items or services related to the administration of the 
          derivative,''.
      (b) Payment for Intravenous Immune Globulin Administration in the 
  Home.--Section 1842(o) of such Act (42 U.S.C. 1395u(o)), as amended by 
  section 3(a), is amended--
              (1) in paragraph (1)(E)(ii), by striking ``paragraph (7)'' 
          and inserting ``paragraph (7) or (8)'';
              (2) by redesignating paragraph (8) as paragraph (9); and
              (3) by inserting after paragraph (7) the following new 
          paragraph:
              ``(8)(A) Subject to subparagraph (B), in the case of 
          intravenous immune globulins described in section 1861(s)(2)(Z) 
          that are furnished on or after January 1, 2010, the Secretary 
          shall provide for a separate payment for items and services 
          related to the administration of such intravenous immune 
          globulins in an amount that the Secretary determines to be 
          appropriate based on a review of available published and 
          unpublished data and information, including the Study of 
          Intravenous Immune Globulin Administration Options: Safety, 
          Access, and Cost Issues conducted by the Secretary (CMS 
          Contract #500-95-0059). Such payment amount may take into 
          account the following:
                      ``(i) Pharmacy overhead and related expenses.
                      ``(ii) Patient service costs.
                      ``(iii) Supply costs.
              ``(B) The separate payment amount provided under this 
          paragraph for intravenous immune globulins furnished in 2010 or 
          a subsequent year shall be equal to the separate payment amount 
          determined under this paragraph for the previous year increased 
          by the percentage increase in the medical care component of the 
          consumer price index for all urban consumers (United States 
          city average) for the 12-month period ending with June of the 
          previous year.''.
      (c) Effective Date.--The amendments made by subsections (a) and (b) 
  shall apply to intravenous immune globulin administered on or after 
  January 1, 2010.
  
  SEC. 5. COLLECTION OF DATA AND REVIEW OF COMPLEXITY CODES FOR PHYSICIAN 
                ADMINISTRATION OF IVIG.
  
      (a) Data Collection.--The Secretary of Health and Human Services 
  may enter into a contract for the collection of data, by not later than 
  6 months after the date of the enactment of this Act, on the practice 
  of IVIG infusion, including collection of data on the complexity of 
  such infusions.
      (b) Data Review.--Not later than 6 months after the date of the 
  enactment of this Act, the Secretary shall review data collected under 
  such contract as well as data submitted by members of the medical 
  community related to the current infusion payment codes under part B of 
  title XVIII of the Social Security Act.
      (c) Modification of Codes.--Upon completion of any data collection 
  under subsection (a) and the review under subsection (b) and not later 
  than 7 months after the date of the enactment of this Act, the 
  Secretary shall--
              (1) provide notice to the appropriate Medicare 
          administrative contractors regarding which existing infusion 
          codes shall be used for purposes of IVIG reimbursement under 
          part B of title XVIII of the Social Security Act; or
              (2) submit to Congress and the RBRUS Committee (RUC) a 
          report on why an additional infusion payment code is necessary.
  
  SEC. 6. REPORTS.
  
      (a) Report by the Secretary.--Not later than 7 months after the 
  date of the enactment of this Act, the Secretary of Health and Human 
  Services shall submit a report to Congress on the following:
              (1) The results of the data collection and review conducted 
          by the Secretary under subparagraph (A) of section 1842(o)(7) 
          of the Social Security Act, as added by section 3(a), and 
          clause (i) of section 1833(t)(14)(I) of such Act, as added by 
          section 3(b).
              (2) Whether the Secretary plans to use the authority under 
          subparagraph (C) of such section 1842(o)(7) and clause (iii) of 
          such section 1833(t)(14)(I) of such Act to provide an 
          additional payment to physicians furnishing intravenous immune 
          globulins and, if the Secretary does not plan to use such 
          authority, the reasons why the payment is appropriate without 
          such an additional payment based on the data collected and 
          reviewed.
      (b) MedPAC Report.--Not later than 2 years after the date of the 
  enactment of this Act, the Medicare Payment Advisory Commission shall 
  submit a report to the Secretary and to Congress that contains the 
  following:
              (1) In the case where the Secretary has used the authority 
          under sections 1842(o)(7)(C) and 1833(t)(14)(I)(iii) of the 
          Social Security Act, as added by subsections (a) and (b), 
          respectively, of section 3 to provide an additional payment to 
          physicians furnishing intravenous immune globulins during the 
          preceding year, an analysis of whether beneficiary access to 
          intravenous immune globulins under the Medicare program under 
          title XVIII of the Social Security Act has improved as a result 
          of the Secretary's use of such authority.
              (2) An analysis of the appropriateness of implementing a 
          new methodology for payment for intravenous immune globulins 
          under part B of title XVIII of the Social Security Act (42 
          U.S.C. 1395k et seq.).
              (3) An analysis of the feasibility of reducing the lag time 
          with respect to data used to determine the average sales price 
          under section 1847A of the Social Security Act (42 U.S.C. 
          1395w-3a).
              (4) Recommendations for such legislation and administrative 
          action as the Medicare Payment Advisory Commission determines 
          appropriate.
  
  SEC. 7. OFFSET.
  
      Section 1861(n) of the Social Security Act (42 U.S.C. 1395x(n)) is 
  amended by adding at the end the following: ``Such term includes 
  disposable drug delivery systems, including elastomeric infusion pumps, 
  for the treatment of colorectal cancer.''.
target: Medicare Patient IVIG Access Act of 2009 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to direct the Secretary of Health and Human Services to collect data on the differences, if any, between: (1) payments to physicians for immune globulins using average sales price payment methodology; and (2) costs incurred by physicians for furnishing these products. Requires the Secretary also to review data on the access of eligible individuals to immune globulins.
  
  Requires the Secretary, after completion of the review, to provide, if appropriate, an additional payment to such physicians for all items related to the furnishing of immune globulins as part of hospital outpatient services.
  
  Provides for Medicare coverage of and payment for intravenous immune globulin (IVIG) administered in the home.
  
  Allows the Secretary to contract for the collection of data on the practice of IVIG infusion.
  
  Directs the Secretary to review data collected under such a contract as well as data submitted by members of the medical community related to the current infusion payment codes under part B (Supplementary Medical Insurance) of SSA title XVIII.
  
  Requires the Secretary, upon completion of any data collection and review, to: (1) notify the appropriate Medicare administrative contractors regarding which existing infusion codes shall be used for purposes of part B IVIG reimbursement; or (2) report to Congress and the RBRUS Committee (RUC) on why an additional infusion payment code is necessary.
  
  Extends the meaning of durable medical equipment to include disposable drug delivery systems, including elastomeric infusion pumps, for the treatment of colorectal cancer.
feat_title: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG).