To amend title XVIII of the Social Security Act to provide for special treatment for certain drugs and biologicals under the prospective payment system for hospital outpatient department services under the Medicare Program.

February 27, 2003

Mr. SHAW 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

To amend title XVIII of the Social Security Act to provide for special treatment for certain drugs and biologicals under the prospective payment system for hospital outpatient department services 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 `Beneficiary Access to Care Act of 2003'.

SEC. 2. TREATMENT OF DRUGS AND BIOLOGICALS UNDER OUTPATIENT HOSPITAL PROSPECTIVE PAYMENT SYSTEM.

(a) SEPARATE APCS FOR MOST DRUGS AND BIOLOGICALS-

(1) IN GENERAL- Section 1833(t)(2) of the Social Security Act (42 U.S.C. 1395l(t)(2) is amended--

(A) by striking `and' at the end of subparagraph (F);

(B) striking the period at the end of subparagraph (G) and inserting `; and'; and

(C) by adding at the end the following:

`(H) the Secretary shall treat as a separate group of covered OPD services--

`(i) any drug or biological that was treated as such a group as of December 31, 2002; and

`(ii) any drug or biological that has ceased to be eligible for transitional, pass-through payments under paragraph (6) by reason of the limited period of payment specified in paragraph (6)(C)(i).'.

(2) EFFECTIVE DATE- The amendments made by paragraph (1) shall apply to items and services furnished on or after January 1, 2004.

(b) PAYMENT RATES FOR NON-PASS-THROUGH DRUGS AND BIOLOGICALS-

(1) PROGRAM PAYMENTS- Section 1833(t) of such Act (42 U.S.C. 1395l(t)) is amended--

(A) in paragraph (3), by amending subparagraph (D) to read as follows:

`(D) CALCULATION OF MEDICARE OPD FEE SCHEDULE AMOUNTS-

`(i) IN GENERAL- The Secretary shall compute a Medicare OPD fee schedule amount for each covered OPD service (or group of such services) furnished in a year, in an amount that (except as provided in clause (ii)) is equal to the product of--

`(I) the conversion factor computed under subparagraph (C) for the year, and

`(II) the relative payment weight (determined under paragraph (2)(C) or paragraph (9)(A)) for the service or group.

`(ii) SPECIAL RULES FOR 2004-

`(I) IN GENERAL- Notwithstanding clause (i), the Medicare OPD

fee schedule amount for 2004 for a drug or biological that is treated as a separate group of covered OPD services and is a single-source drug (as defined in section 1927(k)(7)(A)(iv)) or an innovator multiple source drug (as defined in section 1927(k)(7)(A)(ii)) may not be less than an amount equal to 83 percent of the average wholesale price for the drug or biological.

`(II) NO REVISION OF RELATIVE PAYMENT WEIGHTS- The relative payment weights established under paragraph (9)(A) for 2004 for groups of covered OPD services other than those to which subclause (I) applies shall not be revised to take into account the application of such subclause (I).

`(III) DEFINITION- For purposes of subclause (I), the term `multiple source drug or biological' has the meaning given to the term `multiple source drug' in section 1927(k)(7)(A)(i).';

(B) in paragraph (4)--

(i) in subparagraph (A), by striking `Secretary, as computed under paragraphs (2)(D) and (2)(E)' and inserting `Secretary (as computed under paragraphs (2)(D) and (2)(E)), except that the Medicare OPD fee schedule amount determined under paragraph (3)(D) for a drug or biological that is treated as a separate group of covered OPD services shall not be adjusted for relative differences in the cost of labor'; and

(ii) in subparagraph (B), by striking `adjusted'; and

(C) in paragraph (9), by adding at the end the following:

`(D) USE OF EXTERNAL DATA- In determining the relative payment weight for any drug or biological that is treated as a separate group of covered OPD services for any year after 2003, the Secretary shall adjust the weight otherwise determined under this paragraph with respect to the drug or biological to the extent that reliable and valid data collected and submitted by entities and organizations other than the Department of Health and Human Services (including data submitted in public comments on the proposed rule promulgated with respect to the system established under this subsection for 2004) demonstrate that such payment weight is inadequate or inaccurate. In the case of any adjustments made pursuant to the preceding sentence for 2004, the Secretary shall not revise the relative payment weights for other groups of covered OPD services for such year to take into account such adjustments, and the medicare OPD fee schedule amount determined under paragraph (3)(D) using a relative weight resulting from such an adjustment shall be subject to the minimum amount described in clause (ii)(I) of such paragraph.'.

(2) COPAYMENTS- Section 1833(t)(8)(E) of such Act (42 U.S.C. 1395l(t)(8)(E)) is amended--

(A) in the heading, by striking `OUTLIER AND PASS-THROUGH' and inserting `CERTAIN'; and

(B) by striking `paragraphs (5) and (6)' and inserting `paragraphs (3)(D)(ii), (5), and (6)'.

(3) EXCEPTIONS TO BUDGET NEUTRALITY REQUIREMENT- Section 1833(t)(9)(B) of such Act (42 U.S.C. 1395l(t)(9)(B)) is amended by adding at the end the following: `In determining the budget neutrality adjustment required by the preceding sentence, the Secretary shall not take into account--

`(i) any expenditures that would not have been made but for the application of clause (ii) of paragraph (3)(D); or

`(ii) any expenditures made by reason of an adjustment required by subparagraph (D) for 2004.'.

(c) STUDY OF PHARMACY SERVICES USED TO PROVIDE CANCER DRUG THERAPIES IN HOSPITAL OUTPATIENT SETTING-

(1) IN GENERAL- The Comptroller General of the United States shall conduct a study of payments under part B of title XVIII of the Social Security Act for pharmacy service costs and related costs that are incurred in acquiring chemotherapy and supportive care drugs and providing these therapies to cancer patients in hospital outpatient departments. The study shall--

(A) identify pharmacy costs, including the costs of storage, handling, processing, quality control, disposal, compliance with safety protocols and regulations, establishing dosage regimens that avoid drug interactions and contraindications, and pharmacy overhead;

(B) include a review of the adequacy of the current payment methodology for pharmacy service costs and related costs (including the adequacy of the cost-to-charge ratios used in such methodology); and

(C) identify any changes to that methodology that are necessary to ensure recognition of, and appropriate payment for, all of the services and functions inherent in the provision of cancer treatment in hospital outpatient settings.

(2) REPORT TO CONGRESS- Not later than 12 months after the date of enactment of this Act, the Comptroller General shall submit to Congress a report on the results of the study under paragraph (1), including any recommendations for legislation necessary to implement the changes identified under paragraph (1)(C).

END