text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Quality Cancer Care Preservation 
  Act''.
  
  SEC. 2. MEDICARE PAYMENT FOR DRUGS AND BIOLOGICALS.
  
      (a) In General.--Section 1842(o)(1) of the Social Security Act (42 
  U.S.C. 1395u(o)(1)) is amended by striking ``95 percent of the average 
  wholesale price'' and inserting ``the payment amount specified in 
  section 1834(n)(2)''.
      (b) Determination of Payment Amount.--Section 1834 of such Act (42 
  U.S.C. 1395m) is amended by adding at the end the following new 
  subsection:
      ``(n) Payment for Drugs and Biologicals.--
              ``(1) Reports by manufacturers.--
                      ``(A) In general.--Every drug manufacturer shall 
                  report to the Secretary, in the manner prescribed in 
                  this paragraph, its average sales price (as defined in 
                  subparagraph (B)) in the United States during each 
                  calendar quarter for drugs and biologicals covered 
                  under this part.
                      ``(B) Definitions.--For purposes of this 
                  subsection--
                              ``(i) the term `manufacturer' means, with 
                          respect to a drug or biological, the entity 
                          identified by the Labeler Code portion of the 
                          National Drug Code of such drug or biological; 
                          and
                              ``(ii) the term `average sales price' means 
                          the weighted average of all final sales prices 
                          to all purchasers, excluding sales specified in 
                          subparagraph (C).
                  In determining such average sales prices, such prices 
                  shall be net of volume discounts, chargebacks, short-
                  dated product discounts, free goods contingent on 
                  purchases, rebates (other than those made or authorized 
                  under section 1927), and all other price concessions 
                  that result in a reduction of the ultimate cost to the 
                  purchaser.
                      ``(C) Consideration in calculation of average sales 
                  prices.--The calculation of average sales price under 
                  this subsection shall not include--
                              ``(i) prices that are excluded from the 
                          calculation of `best price' under section 
                          1927(c)(1)(C);
                              ``(ii) prices offered to entities that are 
                          considered under subparagraph (B)(i) to be the 
                          manufacturers of the drugs or biologicals 
                          involved;
                              ``(iii) prices offered by a manufacturer to 
                          a hospital, nursing facility, hospice, or 
                          health maintenance organization;
                              ``(iv) prices to governmental entities; and
                              ``(v) nominal prices offered to bona fide 
                          charitable organizations.
                      ``(D) Quarterly reports.--Each manufacturer shall 
                  submit the report required by subparagraph (A) to the 
                  Secretary by electronic means no later than 30 days 
                  after the end of a calendar quarter with respect to 
                  sales that occurred during such quarter. The Secretary 
                  shall prescribe the format and other requirements for 
                  the report.
                      ``(E) Enforcement.--
                              ``(i) Failure to timely report.--The 
                          Secretary may impose a civil monetary penalty 
                          in an amount not to exceed $100,000 on a 
                          manufacturer that fails to provide the 
                          information required under this paragraph on a 
                          timely basis and in the manner required.
                              ``(ii) False information.--For each item of 
                          false information, the Secretary may impose a 
                          civil money penalty in an amount not to exceed 
                          $100,000 on a manufacturer that knowingly 
                          provides false information under this 
                          paragraph.
                              ``(iii) Manner of imposition of civil 
                          monetary penalties.--The provisions in section 
                          1128A (other than subsections (a) and (b)) 
                          shall apply to a civil monetary penalty under 
                          this subparagraph in the same manner as such 
                          provisions apply to a penalty or proceeding 
                          under section 1128A(a).
                      ``(F) Confidentiality of information.--
                  Notwithstanding any other provision of law, information 
                  disclosed by manufacturers under this paragraph is 
                  confidential and shall not be disclosed by the 
                  Secretary in any form other than as specifically 
                  authorized by this subsection.
              ``(2) Calculation of payment amount.--
                      ``(A) In general.--Except as otherwise provided in 
                  this paragraph, the payment amount for a drug or 
                  biological furnished during a calendar quarter shall be 
                  120 percent of the average sales price of the drug or 
                  biological for the second preceding calendar quarter as 
  determined under paragraph (1).
                      ``(B) Methodology.--In determining payment amounts 
                  under subparagraph (A), the Secretary may, in the 
                  Secretary's discretion, use either the average sales 
                  price for each drug or biological by specific drug or 
                  biological, or a cumulative average sales price based 
                  on sales data for all versions of a multiple-source 
                  drug that the Secretary, acting through the Food and 
                  Drug Administration, has determined are therapeutically 
                  equivalent (as evidenced by `A' ratings in the 
                  publication Approved Drug Products with Therapeutic 
                  Equivalence Evaluations).
                      ``(C) Increase to reflect additional costs 
                  attributable to state and local taxes.--In the case of 
                  a drug or biological that was subject to a State or 
                  local sales tax or gross receipts tax when administered 
                  or dispensed, the payment amount determined under 
                  subparagraph (A) shall be increased by the amount of 
                  such tax paid with respect to such drug or biological.
                      ``(D) Substitution of higher payment amount.--If a 
                  physician's, supplier's, or any other person's claim 
                  for payment for services under this Act documents that 
                  the price paid for a drug or biological was greater 
                  than the payment amount determined under subparagraph 
                  (A), the actual amount paid shall be substituted for 
                  the payment amount determined under subparagraph (A), 
                  unless the Secretary determines that the actual amount 
                  paid was unreasonable under the circumstances.
                      ``(E) Increase for bad debt and certain other 
                  costs.--Upon the submission of supporting information, 
                  the Secretary shall make an additional payment to a 
                  physician or supplier to cover--
                              ``(i) uncollectible deductibles and 
                          coinsurance due from Medicare beneficiaries 
                          with respect to drugs and biologicals furnished 
                          to such beneficiaries; and
                              ``(ii) costs incurred in procuring and 
                          billing for drugs and biologicals furnished to 
                          Medicare beneficiaries.''.
  
  SEC. 3. MEDICARE PAYMENT FOR DRUG ADMINISTRATION SERVICES.
  
      (a) General.--The Secretary of Health and Human Services (hereafter 
  in this Act referred to as ``the Secretary'') shall revise the practice 
  expense relative value units for drug administration services for years 
  beginning with the year 2005 in accordance with this section. For 
  purposes of this section, ``drug administration services'' includes 
  chemotherapy administration services, therapeutic and diagnostic 
  infusions and injections, and such other services as the Secretary 
  specifies.
      (b) Direct Costs Equal to 100 Percent of CPEP Estimates.--Using the 
  information, including estimates of clinical staff time, developed in 
  the clinical practice expert panel process, including refinements by 
  American Medical Association committees, the Secretary shall estimate 
  the costs of the nursing and other clinical staff, supplies, and 
  procedure-specific equipment (exceeding a cost specified by the 
  Secretary) used in furnishing each type of drug administration service. 
  The Secretary shall utilize without revision the minutes of clinical 
  staff time determined in such process. The Secretary shall convert the 
  information from such process to estimated costs by applying the most 
  current available data on staff salary, supply, and equipment costs, 
  and such costs shall be updated to 2005 based on estimated changes in 
  prices since the date of such data.
      (c) Total Practice Expenses.--The Secretary shall estimate the 
  total practice expenses of each drug administration service by assuming 
  that the direct costs for the service determined under subsection (b) 
  are 33.2 percent of such total practice expenses.
      (d) Conversion to Relative Value Units.--The Secretary shall 
  convert the total practice expenses determined under subsection (c) to 
  practice expense relative value units for each drug administration 
  service by dividing such expenses by the conversion factor that will be 
  in effect for the physician fee schedule for 2005. The relative value 
  units as so determined shall be used in determining the fee schedule 
  amounts paid for drug administration services under section 1848 of the 
  Social Security Act (42 U.S.C. 1395w-4).
      (e) Updates.--For years after 2005, the relative values determined 
  under subsection (d) shall continue in effect except that the Secretary 
  shall revise them as necessary to maintain their accuracy, provided 
  that such revisions are consistent with the methodology set forth in 
  this section.
      (f) Multiple Pushes.--In establishing the payment amounts under 
  this section, the Secretary shall establish the payment amount for 
  intravenous chemotherapy administration by push technique based on the 
  administration of a single drug. The Secretary shall make the same 
  payment for each additional drug administered by push technique during 
  the same encounter, except to the extent that the Secretary finds that 
  the cost of administering additional drugs is less than the cost of 
  administering the first drug.
  
  SEC. 4. PAYMENTS FOR CHEMOTHERAPY SUPPORT SERVICES.
  
      (a) General.--Beginning in the year 2005, the Secretary shall 
  recognize and make payments under section 1848 of the Social Security 
  Act (42 U.S.C. 1395w-4) for chemotherapy support services furnished 
  incident to physicians' services. For the purposes of this section, 
  ``chemotherapy support services'' are services furnished by the staff 
  of physicians to patients undergoing treatment for cancer that were not 
  included in the computation of clinical staff costs under section 3(b). 
  Such services include social worker services, nutrition counseling, 
  psychosocial services, and similar services.
      (b) Direct Costs.--The Secretary shall estimate the cost of the 
  salary and benefits of staff furnishing chemotherapy support services 
  as they are provided in oncology practices that furnish these services 
  to cancer patients in a manner that is considered to be high quality 
  care. The estimate shall be based on the weekly cost of such services 
  per patient receiving chemotherapy.
      (c) Total Costs.--The Secretary shall estimate the total practice 
  expenses of chemotherapy support services by assuming that the direct 
  costs for the service determined under subsection (b) are 33.2 percent 
  of such total practice expenses.
      (d) Conversion to Relative Value Units.--The Secretary shall 
  convert the total practice expenses determined under subsection (c) to 
  practice expense relative value units for chemotherapy support services 
  by dividing such expenses by the conversion factor that will be in 
  effect for the physician fee schedule for 2005. The relative value 
  units as so determined shall be used in determining the fee schedule 
  amounts paid for chemotherapy support services under such section 1848.
      (e) Updates.--For the years after 2005, the relative values 
  determined under subsection (d) shall continue in effect except that 
  the Secretary shall revise them as necessary to maintain their 
  accuracy, provided that such revisions are consistent with the 
  methodology set forth in this section.
  
  SEC. 5. CANCER THERAPY MANAGEMENT SERVICES.
  
      The Secretary shall recognize and establish a payment amount for 
  the service of cancer therapy management to account for the greater 
  pre-service and post-service work associated with visits and 
  consultations conducted by physicians treating cancer patients compared 
  to typical visits and consultations. The payment amount may vary by the 
  level and type of the related visit or consultation.
  
  SEC. 6. OTHER SERVICES WITHOUT PHYSICIAN WORK RELATIVE VALUE UNITS.
  
      The Secretary shall develop a revised methodology for determining 
  the payment amounts for services that are paid under the fee schedule 
  established by section 1848 of the Social Security Act (42 U.S.C. 
  1395w-4) and that do not have physician work relative value units, 
  including radiation oncology services. Such methodology shall result in 
  payment amounts that fully cover the costs of furnishing such services. 
  Until such time as the methodology for such services is revised and 
  implemented, all such services shall be protected from further payment 
  cuts due to factors such as shifts in utilization or removal of any one 
  specialty's services that are paid under the fee schedule established 
  by such section 1848 and that do not have physician work relative value 
  units.
  
  SEC. 7. PHYSICIAN SUPERVISION OF SERVICES.
  
      Section 1834 of the Social Security Act (42 U.S.C. 1395m), as 
  amended by section 2, is further amended by adding at the end the 
  following new subsection:
      ``(o) Supervision Requirements.--If the Secretary requires direct 
  supervision of a service by a physician, that supervision requirement 
  may be fulfilled by one or more physicians other than the physician who 
  ordered the service. If the supervising physician is different from the 
  ordering physician for a particular service, the ordering physician may 
  nevertheless bill for such service provided that the medical records 
  for the service involved identify the supervising physician or 
  physicians.''.
  
  SEC. 8. REPORT TO CONGRESS.
  
      No later than April 1, 2004, the Secretary shall submit to Congress 
  a report on the payment amounts that are projected to be adopted under 
  sections 2, 3, 4, and 5 of this Act.
  
  SEC. 9. INSTITUTE OF MEDICINE STUDY.
  
      (a) General.--The Secretary of Health and Human Services shall 
  request the Institute of Medicine to conduct the study described in 
  this section.
      (b) Baseline Study.--The first phase of the study shall include the 
  following objectives:
              (1) An assessment of the extent to which the current 
          Medicare payment system, prior to implementation of the 
          amendments made by this Act, facilitates appropriate access to 
          care by cancer patients in the various treatment settings.
              (2) The identification of the comprehensive range of 
          services furnished to cancer patients in the outpatient 
          setting, including support services such as psychosocial 
          services and counseling, and recommendations regarding the 
          types of services that ought to be furnished to Medicare 
          patients with cancer.
              (3) A discussion of the practice standards necessary to 
          assure the safe provision of services to cancer patients.
              (4) An analysis of the extent to which the current Medicare 
          payment system supports the role of nurses in the provision of 
          oncology services and recommendations for any necessary 
          improvements in the payment system in that respect.
              (5) The development of a framework for assessing how the 
          amendments made by this act affect the provision of care to 
          Medicare patients with cancer in the various treatment 
          settings.
      (c) Second Phase of Study.--After the implementation of the 
  amendments made by this Act, the study shall determine whether and how 
  those amendments affected the provision of care to Medicare patients 
  with cancer.
      (d) Consultation.--The Institute of Medicine shall consult with the 
  National Cancer Policy Board and organizations representing cancer 
  patients and survivors, oncologists, oncology nurses, social workers, 
  cancer centers, and other healthcare professionals who treat cancer 
  patients in planning and carrying out this study.
      (e) Due Dates.--
              (1) The study required by subsection (b) shall be submitted 
          to the Congress and the Secretary of Health and Human Services 
          no later than June 30, 2004.
              (2) The study required by subsection (c) shall be submitted 
          to the Congress and the Secretary of Health and Human Services 
          no later than December 31, 2006.
  
  SEC. 10. EFFECTIVE DATES.
  
      (a) General.--Except as provided in this section, the provisions of 
  this Act shall apply to drugs, biologicals, and services furnished on 
  or after January 1, 2005.
      (b) Reports From Manufacturers.--The first report by manufacturers 
  required by the provisions of section 2 shall be submitted no later 
  than October 30, 2004, with respect to sales that occurred in the 
  quarter ending September 30, 2004.
      (c) Supervision of Services.--The amendment made by section 7 shall 
  be effective upon enactment.
      (d) Services Other Than Drug Administration.--The Secretary shall 
  implement the requirements of section 6 no later than January 1, 2005.
target: Quality Cancer Care Preservation Act - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act (SSA) to revise the payment amount for covered drugs and biologicals furnished during a calendar quarter that are not paid on a cost or prospective payment basis. Changes such amount from 95 percent of the average wholesale price to 120 percent of the average sales price of the drug or biological for the second preceding calendar quarter. Requires drug manufacturers to report average sales prices each calendar quarter for covered drugs and biologicals.Directs the Secretary of Health and Human Services to: (1) revise the practice expense relative value units for drug administration services (including chemotherapy administration services) in accordance with this Act to determine the units to be used in determining the fee schedule amounts paid for drug administration services under the Medicare program; (2) recognize and make payments under Medicare for chemotherapy support services furnished incident to physicians' services; (3) recognize and establish a payment amount for the service of cancer therapy management to account for the greater pre-service and post-service work associated with visits and consultations conducted by physicians treating cancer patients compared to typical visits and consultations; and (4) develop a revised methodology for determining the payment amounts for services that are paid under the Medicare fee schedule and that do not have physician work relative value units, including radiation oncology services.Amends SSA title XVIII to provide that if the Secretary requires direct supervision of a service by a physician, that supervision requirement may be fulfilled by one or more physicians other than the physician who ordered the service.
feat_title: A bill to amend title XVIII of the Social Security Act and otherwise revise the Medicare Program to reform the method of paying for covered drugs, drug administration services, and chemotherapy support services.