CLINICAL DIAGNOSTIC LABORATORY TESTS.

SEC. 4064. CLINICAL DIAGNOSTIC LABORATORY TESTS. (a) Limitation on Changes in Fee Schedules.— (1) 3-month freeze in fee schedules.— Notwithstanding any other provision of law, any change in the fee schedules for clinical laboratory diagnostic laboratory tests under part B of title XVIII of such Act which would have become effective for tests furnished on or after January 1, 1988, shall not be effective for tests furnished during the 3-month period beginning on January 1, 1988. (2) No cpi increase in 1988.— Notwithstanding any other provision of law, the Secretary of Health and Human Services shall not adjust the fee schedules established under section 1833(h) of the Social Security Act for 1988 to take into account any increase in the consumer price index. (b) Fee Schedules and Payment Limits.— (1) Rebasing of fee schedules for certain automated and similar tests.— Section 1833(h)(2) of the Social Security Act (42 U.S.C. 13951(h)(2)) is amended by adding at the end the following: “In establishing fee schedules under the first sentence of this paragraph with respect to automated tests and tests (other than cytopathology tests) which before July 1, 1984, the Secretary made subject to a limit based on lowest charge levels under the sixth sentence of section 1842(b)(3) performed after March 31, 1988, the Secretary shall reduce by 8.3 percent the fee schedules otherwise established for 1988.”. (2) Nationwide payment limits.— Section 1833(h)(4)(B) of such Act is amended— (A) in clause (i), by striking “January” and inserting “April”, and (B) by amending clause (ii) to read as follows: “(ii) March 31, 1988, and so long as a fee schedule for the test has not been established on a nationwide basis, is equal to the median of all the fee schedules established for that test for that laboratory setting under paragraph (1).”. (3) Effective dates.— The amendments made by paragraphs (1) and (2) shall apply with respect to services furnished on or after April 1, 1988. (4) GAO study of fee schedules.— The Comptroller General shall conduct a study of the level of the fee schedules established for clinical diagnostic laboratory services under section 1833(h)(2) of the Social Security Act to determine, based on the costs of, and revenues received for, such tests the appropriateness of such schedules. The Comptroller General shall report to the Congress on the results of such study by not later than January 1, 1990. Suppliers of such tests which fail to provide the Comptroller General with reasonable access to necessary records to carry out the study under this paragraph are subject101 STAT. 1330–111 to exclusion from the medicare program under section 1128(a) of the Social Security Act. (c) Limitation on Application of 2 Percent Hospital Lab Differential.— Section 1833(h)(2) of such Act is amended by striking “hospital laboratory” and inserting “laboratory in a sole community hospital”. (d) Intermediate Sanctions.— (1) Part B of title XVIII of such Act is amended by adding at the end thereof the following new section: “intermediate sanctions for providers of clinical diagnostic laboratory tests35b35bCopy read “tests” ”. “Sec. 1846. (a) If the Secretary determines that any provider or clinical laboratory certified for participation under this title no longer substantially meets the conditions of participation specified under this title with respect to the provision of clinical diagnostic laboratory tests under this part, the Secretary may (for a period not to exceed one year) impose intermediate sanctions developed pursuant to subsection (b), in lieu of canceling immediately the certification of the provider or clinical laboratory. “(b) (1) The Secretary shall develop and implement— “(A) a range of intermediate sanctions to apply to providers or certified clinical laboratories under the conditions described in subsection (a), and “(B) appropriate procedures for appealing determinations relating to the imposition of such sanctions. “(2) (A) The intermediate sanctions developed under paragraph (1) shall include— “(i) directed plans of correction, “(ii) civil fines and penalties, “(iii) payment for the costs of onsite monitoring by an agency responsible for conducting certification surveys, and “(iv) suspension of all or part of the payments to which a provider or certified clinical laboratory would otherwise be entitled under this title with respect to clinical diagnostic laboratory tests provided on or after the date in which the Secretary determines that intermediate sanctions should be imposed pursuant to subsection (a).3636Subparagraphs “ ‘(i)”, “ ‘(ii)”, “ ‘(iii)”, and “ ‘(iv)” indented incorrectly. “(B) The sanctions specified in subparagraph (A) are in addition to sanctions otherwise available under State or Federal law. “(3) The Secretary shall develop and implement specific procedures with respect to when and how each of the intermediate sanctions developed under paragraph (1) is to be applied, the amounts of any fines, and the severity of each of these penalties. Such procedures shall be designed so as to minimize the time between identification of violations and imposition of these sanctions and shall provide for the imposition of incrementally more severe fines for repeated or uncorrected deficiencies.”. (2) The amendment made by paragraph (1) shall become effective on January 1, 1990. (e) State Certification of High-Volume Physician Office Labs.— (1) Section 1861(s) of such Act (42 U.S.C. 1395x(s)) is amended, in the sentence following paragraph (11), by inserting “a labora-101 STAT. 1330–112tory not independent of a physician’s office that has a volume of clinical diagnostic laboratory tests exceeding 5,000 per year” after “physician’s office,”. (2) The amendment made by paragraph (1) shall apply to diagnostic tests performed on or after January 1, 1990.