The Centers for Medicare & Medicaid Services (CMS) opened the national coverage determination (NCD) on FDG-PET for a limited-scope reconsideration on May 8, to consider broadening national coverage--without coverage with evidence development (CED) restrictions--for the staging of cervical cancer. The requestors said that CMS may find it appropriate to exclude coverage for cervical cancer diagnosis, "since this disorder is initially diagnosed by biopsy."
The requestors are:
- Bruce E. Hillner, MD, department of internal medicine, Virginia Commonwealth University;
- R. Edward Coleman, MD, vice-chairman, department of radiology director, division of nuclear medicine, Duke University School of Medicine;
- Anthony F. Shields, MD, PhD, professor of medicine and oncology, Karmanos Cancer Institute; and
- Barry A. Siegel, MD, chief, division of nuclear medicine, Mallinckrodt Institute of Radiology.
FDG-PET is currently covered nationally when it is used by the beneficiary's physician to guide the subsequent management of cervical cancer in women who have undergone anticancer treatment. It is also nationally covered for some uses in cervical cancer patients who have not yet received anticancer treatment. FDG-PET imaging is covered as an adjunct test for detecting pre-treatment metastasis in newly diagnosed cervical cancers following conventional imaging that is negative for extra-pelvic metastasis, according to SNM.
Medicare coverage of all other uses of FDG-PET related to cervical cancer is restricted to beneficiaries who are enrolled in a prospective clinical study under a CED program, such as the 2009 National Oncology PET Registry (NOPR).
"Through NOPR and other published studies in recent years, significant clinical evidence supporting the inclusion of expanded PET coverage for cervical cancer has been developed.... We thus believe that the continuing exclusion of cervical cancer coverage of PET for this subset of patients with newly diagnosed disease was likely unintentional, since the new NCD was designed to establish a consistent general coverage framework for similar cancers and similar clinical oncology decisions, and to obviate cancer-by-cancer coverage determinations across every family of related cancers," the requestors wrote.
They suggested the language be changed to state: "FDG-PET is covered for the staging of cervical cancer in beneficiaries who have a histopathologic diagnosis of cervical cancer established by biopsy; and FDG-PET is not covered for the diagnosis of cervical cancer."
The agency is accepting public comment until June 7. A proposed decision memo is expected by Nov. 8 and a final decision by Feb. 6, 2010.