On July 19, 2007, the Centers for Medicare and Medicaid Services (CMS) issued the proposed decision memorandum regarding its clinical trial policy (CTP) national coverage determination (NCD) that was promised in its final decision notice of July 9 (see “CMS Revised Clinical Trial Policy Preserves the Status Quo, but Changes May Be Afoot,” Health Update, Hogan & Hartson, 07.12.2007, http://www.hhlaw.com/newsstand/pubDetail.aspx?publication=3150). While it has the virtue of allowing providers to self-certify that their clinical trials meet CMS’s 13 coverage criteria, this NCD apparently would still withdraw coverage for “usual patient care” items and services in trials that do not meet the criteria. The NCD thus would provide a path to coverage of items and services provided as part of clinical trials, but it would create new regulatory requirements to obtain such coverage, even for “usual patient care” that would otherwise be covered. The proposed NCD may be viewed in its entirety at http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=210 , and CMS will accept public comments until August 18.


The original CTP NCD, issued by CMS (then known as the Health Care Financing Administration, or HCFA) in 2000, states that Medicare will cover routine patient costs in qualifying clinical trials. Under the CTP NCD, certain trials funded or required by certain federal government agencies are deemed to be “qualifying,” and other trials would be eligible to qualify through a separate process that was never implemented. In July 2006, CMS announced that it was reconsidering this policy and sought public comments on ten issues related to the policy. As part of its reconsideration of the policy, CMS convened a meeting the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) in December 2006, and subsequently issued a draft decision memorandum to revise the CTP NCD in April 2007. The proposed decision would have added definitions of key terms and revised standards for coverage of clinical trials. Apparently in response to Hogan & Hartson and other stakeholders’ concerns about the proposal, CMS issued a final decision memorandum on July 9, 2007 that mostly preserved the status quo. In that memorandum, however, CMS announced that it intended to amend its clinical trial and claims processing policies “so that they are clear and consistent.” The July 19 proposed decision memorandum is the follow-up to that stated intent.

The Proposed Decision Memorandum Imposes New Requirements for Coverage of “Usual Patient Care” if it is Furnished to a Medicare Patient Enrolled in a Clinical Trial

In the proposed decision memorandum, CMS abandons the distinction between “Medicare specific” and other clinical trial criteria, in favor of a list of thirteen criteria that must be met in order for items and services furnished as part of a clinical trial to be paid by Medicare. The NCD makes clear that it would apply to coverage even of routine “usual patient care” items and services that would otherwise be covered without regard to satisfying the thirteen criteria. Apart from certain non-interventional studies devoted simply to data collection, and to studies covered under the investigational device exemption regulations, the NCD would apply to all clinical studies involving Medicare patients. No longer would government-funded or FDA-mandated trials be “deemed” to qualify: all trials would have to satisfy the thirteen criteria.

CMS proposes that study sponsors/principal investigators be allowed to self-certify that their trials meet the thirteen criteria, and states that it will only review self-certification for completeness—not for accuracy. However, the NCD also states that the CMS Chief Medical Officer may deny coverage if he or she determines that the trial does not meet the criteria, or if patient safety is threatened. It is not clear what if any legal process CMS intends to allow providers and sponsors to challenge such decisions. In addition, this new certification requirement would expose those filing the required certifications, or “causing” such certifications to be filed, to false claims/false statement risks on sometimes subjective criteria, such as whether the study does not “unjustifiably” duplicate existing studies. In addition to these risks, some of the criteria—such as those requiring discussion of subpopulations and requiring public release of results—may be objectionable to some trial sponsors.

Next Steps

Comments on the proposed decision memorandum must be filed with CMS by August 18, 2007. As we have previously argued to CMS, we continue to believe that the agency lacks the legal authority to withdraw otherwise available Medicare coverage for “usual patient care” and impose these additional criteria for Medicare payment for such care. Stakeholders who have concerns with the mandatory nature of the proposed coverage criteria—particularly as they would create new coverage hurdles for routine “usual patient care” items and services—or who wish to comment on some other aspect of the proposed NCD, should be cognizant of this filing deadline. Please let us know if we can be of any assistance.