CMS lifts some restrictions on one study for oncology PET policy

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Volume rendering of staging 18F-FDG PET demonstrates difficulties posed in defining primary lesion dimensions on CT in presence of atelectasis.
The Centers for Medicare & Medicaid Services (CMS) has proposed to remove some restrictions for only one FDG-PET study for Medicare beneficiaries for the location and/or extent of a tumor.

The agency was asked to reconsider the April 3, 2009 National Coverage Determinations (NCD) provision at Section 220.6.17 of the NCD Manual that established an absolute frequency limitation of only one FDG-PET study for these purposes:
  • To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
  • To determine the optimal anatomic location for an invasive procedure; or
  • To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

In response, CMS said that the current absolute restriction is not supported by the available evidence and therefore proposes to amend 220.6.17 of the NCD Manual:
  • The NCD will be changed to remove the current absolute restriction of coverage to ‘only one’ FDG-PET scan to determine the location and/or extent of the tumor for the therapeutic purposes related to the initial treatment strategy as described above;
  • CMS will continue to nationally cover one FDG PET scan to determine the location and/or extent of the tumor for the therapeutic purposes related to the initial treatment strategy as described above; and
  • Local Medicare administrative contractors will have discretion to cover (or not cover) within their jurisdictions any additional FDG PET scan for the therapeutic purposes related to the initial treatment strategy as described above.

CMS said it is requesting public comments on this proposed decision memorandum pursuant to §1862(l)(3) of the Social Security Act. After considering the public comments and any additional evidence, CMS will make a final determination and issue a final decision memorandum.