42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.

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There are 2 Updates appearing in the Federal Register for 42 CFR 414. View below or at eCFR (GPOAccess)
§ 414.508 Payment for a new clinical diagnostic laboratory test.
For a new clinical diagnostic laboratory test that is assigned a new or substantially revised code on or after January 1, 2005, CMS determines the payment amount based on either of the following:
(a) Crosswalking. Crosswalking is used if it is determined that a new test is comparable to an existing test, multiple existing test codes, or a portion of an existing test code.
(1) CMS assigns to the new test code, the local fee schedule amounts and national limitation amount of the existing test.
(2) Payment for the new test code is made at the lesser of the local fee schedule amount or the national limitation amount.
(b) Gapfilling. Gapfilling is used when no comparable existing test is available.
(1) In the first year, carrier-specific amounts are established for the new test code using the following sources of information to determine gapfill amounts, if available:
(i) Charges for the test and routine discounts to charges;
(ii) Resources required to perform the test;
(iii) Payment amounts determined by other payers; and
(iv) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
(2) In the second year, the test code is paid at the national limitation amount, which is the median of the carrier-specific amounts.
(3) For a new test for which a new or substantially revised HCPCS code was assigned on or before December 31, 2007, after the first year of gapfilling, CMS determines whether the carrier-specific amounts will pay for the test appropriately. If CMS determines that the carrier-specific amounts will not pay for the test appropriately, CMS may crosswalk the test.
[71 FR 69786, Dec. 1, 2006, as amended at 72 FR 66401, Nov. 27, 2007]

Title 42 published on 2014-10-01

The following are only the Rules published in the Federal Register after the published date of Title 42.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-11-13; vol. 79 # 219 - Thursday, November 13, 2014
    1. 79 FR 67548 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Final rule with comment period.
      Effective date: The provisions of this final rule are effective on January 1, 2015, with the exception of amendments to parts 412, 413, and 495 which are effective October 31, 2014. Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 30, 2014. Compliance date: The compliance date for new data collection requirements in § 403.904(c)(8) is January 1, 2016.
      42 CFR Parts 403, 405, 410, 411, 412, 413, 414, 425, 489, 495, and 498

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United States Code
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Title 42 published on 2014-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR 414 after this date.

  • 2014-11-13; vol. 79 # 219 - Thursday, November 13, 2014
    1. 79 FR 67548 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Final rule with comment period.
      Effective date: The provisions of this final rule are effective on January 1, 2015, with the exception of amendments to parts 412, 413, and 495 which are effective October 31, 2014. Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 30, 2014. Compliance date: The compliance date for new data collection requirements in § 403.904(c)(8) is January 1, 2016.
      42 CFR Parts 403, 405, 410, 411, 412, 413, 414, 425, 489, 495, and 498