Title 42
SECTION 414.507
414.507 Payment for clinical diagnostic laboratory tests.
§ 414.507 Payment for clinical diagnostic laboratory tests.(a) General rule. Except as provided in paragraph (d) of this section, and §§ 414.508 and 414.522, the payment rate for a CDLT furnished on or after January 1, 2018, is equal to the weighted median for the test, as calculated under paragraph (b) of this section. Each payment rate will be in effect for a period of one calendar year for ADLTs and three calendar years for all other CDLTs, until the year following the next data collection period.
(b) Methodology. For each test under paragraph (a) of this section for which applicable information is reported, the weighted median is calculated by arraying the distribution of all private payor rates, weighted by the volume for each payor and each laboratory.
(c) The payment amounts established under this section are not subject to any adjustment, such as geographic, budget neutrality, annual update, or other adjustment.
(d) Phase-in of payment reductions. For years 2018 through 2024, the payment rates established under this section for each CDLT that is not a new ADLT or new CDLT, may not be reduced by more than the following amounts for -
(1) 2018 - 10 percent of the national limitation amount for the test in 2017.
(2) 2019 - 10 percent of the payment rate established in 2018.
(3) 2020 - 10 percent of the payment rate established in 2019.
(4) 2021 - 0.0 percent of the payment rate established in 2020.
(5) 2022 - 15 percent of the payment rate established in 2021.
(6) 2023 - 15 percent of the payment rate established in 2022.
(7) 2024 - 15 percent of the payment rate established in 2023.
(e) There is no administrative or judicial review under sections 1869 and 1878 of the Social Security Act, or otherwise, of the payment rates established under this subpart.
(f) Effective April 1, 2014, the nominal fee that would otherwise apply for a sample collected from an individual in a Skilled Nursing Facility (SNF) or by a laboratory on behalf of a Home Health Agency (HHA) is $5.
(g) For a CDLT for which CMS receives no applicable information, payment is made based on the crosswalking or gapfilling methods described in § 414.508(b)(1) and (2).
(h) For ADLTs that are furnished between April 1, 2014 and December 31, 2017, payment is based on the crosswalking or gapfilling methods described in § 414.508(a).
[81 FR 41099, June 23, 2016, as amended at 85 FR 85028, Dec. 28, 2020]