Pub. L. 101-508, tit. IV, subtit. A, pt. 3, sec. 4201
PROVISIONS RELATING TO END STAGE RENAL DISEASE.
SEC. 4201. PROVISIONS RELATING TO END STAGE RENAL DISEASE. (a) Increase in Composite Rates.—Section 9335(a)(D of the Omnibus Budget Reconciliation Act of 1986, as amended by section 6203(a)(l) of the Omnibus Budget Reconciliation Act of 1989, is amended— (1) by striking “October 1, 1990,” and inserting “December 31, 1990,”; and (2) by inserting after the first sentence the following: “With respect to services furnished on or after January 1, 1991, such base rate shall be equal to the respective rate in effect as of September 30, 1990 (determined without regard to any reductions imposed pursuant to section 6201 of the Omnibus Budget Reconciliation Act of 1989), increased by $1.00.”. (b) PROPAC Study on ESRD Composite Rates.— (1) In general.— (A) Study.—The Prospective Payment Assessment Commission (in this subsection referred to as the “Commission”) shall conduct a study to determine the costs and services and profits associated with various modalities of dialysis treatments provided to end stage renal disease 104 STAT. 1388–103patients provided under title XVIII of the Social Security Act. (B) Recommendations.— Based on information collected for the study described in subparagraph (A), the Commission shall make recommendations to Congress regarding the method or methods and the levels at which the payments made for the facility component of dialysis services by providers of service and renal dialysis facilities under title XVIII of the Social Security Act should be established for dialysis services furnished during fiscal year 1993 and the methodology to be used to update such payments for subsequent fiscal years. In making recommendations concerning the appropriate methodology the Commission shall consider— (i) hemodialysis and other modalities of treatment, (ii) the appropriate services to be included in such payments, (iii) the adjustment factors to be incorporated including facility characteristics, such as hospital versus free-standing facilities, urban versus rural, size and mix of services, (iv) adjustments for labor and nonlabor costs, (v) comparative profit margins for all types of renal dialysis providers of service and renal dialysis facilities, (vi) adjustments for patient complexity, such as age, diagnosis, case mix, and pediatric services, and (vii) efficient costs related to high quality of care and positive outcomes for all treatment modalities. (2) Report.—Not later than June 1, 1992, the Commission shall submit a report to the Committee on Finance of the Senate, and the Committees on Ways and Means and Energy and Commerce of the House of Representatives on the study conducted under paragraph (1)(A) and shall include in the report the recommendations described in paragraph (1)(B), taking into account the factors described in paragraph (1)(B). (3) Annual report.—The Commission, not later than March 1 before the beginning of each fiscal year (beginning with fiscal year 1993) shall report its recommendations to the Committee on Finance of the Senate and the Committees on Ways and Means and Energy and Commerce of the House of Representatives on an appropriate change factor which should be used for updating payments for services rendered in that fiscal year. The Commission in making such report to Congress shall consider conclusions and recommendations available from the Institute of Medicine. (c) Payment Rates for Erythropoietin.— (1) In general.— Section 1881(b)(ii) of the Social Security Act (42 U.S.C. 1395rr(b)) is amended— (A) by striking “(11)” and inserting “(11)(A)”; and (B) by adding at the end the following new subparagraph: “(B) Erythropoietin, when provided to a patient determined to have end stage renal disease, shall not be included as a dialysis service for purposes of payment under any prospective payment amount or comprehensive fee established under this section, and payment for such item shall be made separately— “(i) in the case of erythropoietin provided by a physician, in accordance with section 1833; and 104 STAT. 1388–104 “(ii) in the case of erythropoietin provided by a provider of services, renal dialysis facility, or other supplier of home dialysis supplies and equipment— “(I) for erythropoietin provided during 1991, in an amount equal to $11 per thousand units (rounded to the nearest 100 units), and “(II) for erythropoietin provided during a subsequent year, in an amount determined to be appropriate by the Secretary, except that such amount may not exceed the amount determined under this clause for the previous year increased by the percentage increase (if any) in the implicit price deflator for gross national product (as published by the Department of Commerce) for the second quarter of the preceding year over the implicit price deflator for the second quarter of the second preceding year.” . (2) Effective date.—The amendments made by paragraph (1) shall apply to erythropoietin furnished on or after January 1, 1991. (d) Self-Administered Erythropoietin.— (1) Coverage.— Section 1861(s)(2) (42 U.S.C. 1395x(s)(2)) as amended by section 4156(a)(D» is amended— (A) by striking “and” at the end of subparagraph (N); (B) by adding ȁCand” at the end of subparagraph (O); and (C) by adding at the end the following new subparagraph: “(P) erythropoietin for home dialysis patients competent to use such drug without medical or other supervision with respect to the administration of such drug, subject to methods and standards established by the Secretary by regulation for the safe and effective use of such drug, and items related to the administration of such drug;”. (2) Coverage for method n patients.— Section 1881(b) (42 U.S.C. 1395rr(b)) is further amended— (A) in paragraph (1)— (B) by striking “and (B)” and inserting “(B),1818So in original. Probably should be ““(B)”,”. and”. (C) by striking “equipment.” and inserting “equipment, and (C) payments to a supplier of home dialysis supplies and equipment that is not a provider of services, a renal dialysis facility, or a physician for self-administered erythropoietin as described in section 1861(s)(2)(Q) if the Secretary finds that the patient receiving such drug from such a supplier can safely and effectively administer the drug (in accordance with the applicable methods and standards established by the Secretary pursuant to such section).”; and (3) by adding at the end of paragraph (11), as amended by subsection (c), the following new subparagraph: “(C) The amount payable to a supplier of home dialysis supplies and equipment that is not a provider of services, a renal dialysis facility, or a physician for erythropoietin shall be determined in the same manner as the amount payable to a renal dialysis facility for such item.”. (3) Effective date.—The amendments made by paragraphs (1) and (2) shall apply to items and services furnished on or after July 1, 1991.