February 2, 2005

Medicare Announces Final Decision on PET for Noncovered Cancers

The Centers for Medicare and Medicaid Services (CMS) has published the final decision memorandum for the National Coverage Analysis (NCA) for Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung and Testicular Cancers (CAG-00181N).

Final Decision Summary (Published January 28, 2005)

CMS has determined that there is sufficient evidence to conclude that an FDG PET scan for the detection of pre-treatment metastases (i.e., staging) in newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extra-pelvic metastasis is reasonable and necessary as an adjunct test, and CMS intends to issue a national coverage determination (NCD) for this indication.

Special Note: The NCD will contain complete coverage criteria and coding guidance. According to Stuart Caplan, CMS Lead Analyst, providers should hold claims for this service until CMS issues the NCD instructions, which should be published within the next two weeks.

For all other indications in this decision memorandum, CMS has determined that the evidence is sufficient to conclude that an FDG PET scan is reasonable and necessary only when the provider is participating in and patients are enrolled in one of the following types of prospective clinical studies:

	A clinical trial of FDG PET that meets the requirements of Food and Drug Administration (FDA) category B investigational device exemption (42 CFR 405.201) or;
	An FDG PET clinical study (i.e. PET database registry*) that is designed to collect additional information at the time of the scan to assist in patient management.

The clinical study must ensure that:

1.	Specific hypotheses are identified prospectively;
2.	Hospitals and providers are qualified to provide the FDG PET scan and interpret the results;
3.	Participating hospitals and providers report data on all enrolled patients undergoing FDG PET scans for cancer therapeutic or diagnostic indications;
4.	The data to be collected includes:
		Baseline patient characteristics
		Scan type and characteristics
		Scan results
		Results of all other imaging studies
		Facility and provider characteristics
		Information on cancer type, grade, and stage
		Long-term patient outcomes and disease management changes
		Anti-cancer treatment received
		All applicable patient confidentiality, privacy, and other Federal laws are complied with, including the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule).

In a related press release CMS also made the following statements:

The expansion in PET scan benefits makes this test available to patients when the patient and doctor participate in high quality clinical studies or submit information to a PET database. The data collected as part of this policy will help ensure that the PET information is used accurately and appropriately in patient management and will also help doctors and Medicare beneficiaries make better-informed choices about their health care.

*A working group that includes representatives from clinical oncologists, imaging organizations, academic institutions, and industry is developing the PET database (registry). Medicare coverage will become effective when the database is fully established within the next several months.

The CMS Council on Technology and Innovation will now begin to develop a draft guidance document on this policy approach in order to make the process more systematic, predictable and transparent. An open door forum on this topic will be held on Feb 14, 2005, to obtain public input on linking coverage to practical trials and databases. In addition, comments on this approach can be submitted to the CTI website (http://www.cms.hhs.gov/providers/cti). An initial draft guidance will be issued by March 31, 2005, at which time additional public feedback will be solicited.

All other previous positive national coverage determinations will remain in effect. (See Appendix A.)

All other previous national non-coverage determinations based on evidence of lack of benefit will remain in effect. (See Appendix A.)

For all other indications for which CMS currently has a non-coverage determination (see Appendix A), CMS has determined that an FDG PET scan is reasonable and necessary only when the provider is participating in and patients are enrolled in one of the prospective clinical studies described above.
 

¹ Covered nationally based on evidence of benefit. Refer to National Coverage Determination Manual for specific coverage language and limitations for each indication.
http://www.cms.hhs.gov/manuals/103_cov_determ/ncd103c1_Part4.pdf

² Non-covered nationally based on evidence of harm or no benefit.

³ Non-covered nationally based on lack of evidence sufficient to establish either benefit or harm, or no prior decision addressing this cancer.

* Monitoring = monitoring response to treatment when a change in therapy is anticipated.

The final decision memorandum for Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung and Testicular Cancers (CAG-00181N) can be found at: https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=92

The related CMS press release can be found at: http://www.cms.hhs.gov/media/press/release.asp?Counter=1337

Note: find a print-friendly version of this and other Cardinal Health PET eNews items at http://nps.cardinal.com/nps/content/nucpharm/pet/pet_serv-dev_enews-arch.asp