Patients on clinical trials have had a problematic history with insurance carriers. President Clinton signed an executive memorandum in 2000, “authorize[ing Medicare] payment for routine patient care costs. . .and costs due to medical complications associated with participation in clinical trials.” Under this memorandum, the clinical trial services that qualify for coverage include those that have therapeutic intent and are “deemed” trials. Those trials that are automatically qualified include:
Trials funded by federal agencies or their centers or cooperative groups;
Trials conducted under an investigational new drug application (IND); and
Drug trials that are IND-exempt.
Covered routine costs of a qualified trial included all items and services that are otherwise generally available to Medicare beneficiaries including:
those provided absent a clinical trial (e.g., conventional care);
those required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent);
those required for the clinically appropriate monitoring of the effects of the investigational item or service, or the prevention of complications; and
those needed for reasonable and necessary care, for the diagnosis or treatment of complications.
Services not covered include:
The investigational item or service itself;
Items and services:
for which there is no Medicare benefit category or that are statutorily excluded,
furnished solely to satisfy data collection and analysis,
customarily provided by research sponsor,
provided solely to determine eligibility
Recently, the Centers for Medicare and Medicaid Services (CMS) released a proposed revised national coverage decision for the Clinical Trial Policy. ASH has sent comments to CMS regarding some of the important changes in the proposed NCD .
These new proposals (in italics), followed by ASH’s comments, include:
ASH believes in the peer-review publication process to verify the scientific legitimacy of the results. However, the timeline for the public release of a study in a peer-reviewed journal is difficult to determine because of the peer review process itself. In addition to peer-reviewed publications, we suggest that an alternative mechanism for sharing of information would be a summary paragraph linked to ClinicalTrials.gov.
“The research study protocol contains a discussion of how the results will generalize to the Medicare population to infer whether Medicare patients may benefit from the intervention.”ASH believes that a Medicare beneficiary eligible for the study, even though he/she may be in the minority, should not be denied coverage for standard of care items because the study did not meet this proposed standard. ASH proposes amending the proposed standard to allow the researcher to state the reasons why a particular study may not be generalizeable to the entire Medicare population.
ASH commented that institutions that have received the new NIH Clinical Translational Science Award should be given delegated authority to deem studies.
There are many additional issues that are detailed in the ASH comment letter. Members of the Committee on Government Affairs, the Committee on Practice, and the Executive Committee helped draft the ASH comment letter. We will now wait to see how CMS responds.
