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Research and Regulatory, Affairs Capitol Associates, Inc.,426 C. Street NE, Washington DC 20002, md{at}capitolassociates.com

MEDICARE COVERAGE OF CLINICAL TRIALS

On June 7, 2000, President William Jefferson Clinton issued an executive memorandum which directed the Health Care Financing Administration (HCFA) to "authorize payment for routine patient care costs" of clinical trials, as well as "costs due to medical complications associated with participation in clinical trials." On August 4, 2000, HCFA issued a proposed National Coverage Decision (NCD) requesting comments from the public on the coverage decision proposal. The final NCD, issued by HCFA on September 18, 2000, went into effect on September 19, 2000.

The final NCD is a direct result of the collaborative efforts this past summer by the Department of Health and Human Services and its relevant agencies with several cancer advocacy organizations including the National Coalition of Cancer Survivorship, the Cancer Leadership Council, the American Cancer Society, the National Breast Cancer Coalition, the American Society of Clinical Oncology, and the National Coalition for Cancer Research. During a series of meetings and behind the scenes activities with several Federal agencies the structure of the NCD was hammered out to reflect the intent of the Executive Order.

The NCD is binding on all Medicare carriers, fiscal intermediaries, Peer Review Organizations, Health Maintenance Organizations, Competitive Medical Plans, Health Care Prepayment Plans, and Medicare + Choice organizations. Further, the final decision clarifies that an administrative law judge may not "disregard, set aside, or otherwise review" the coverage decision. Based upon the NCD, Medicare will cover the routine costs of qualifying clinical trials and the associated items and services used to diagnose and treat complications arising from the participation in a clinical trial. Key provisions of the NCD are outlined below.

Routine Costs
Routine costs are considered to be all the items and services available under Medicare provided in the experimental or control arm of a clinical trial with the following exceptions: the investigational item or service; any item or service necessary to solely satisfy data collection or analysis of items unrelated to clinical management of the patient; and, items and services provided by the clinical trial sponsor in the trial. Costs that will be covered under the NCD are items and services routinely provided outside of a clinical trial; items or services associated with the provision or delivery of the investigational item or service; the clinical monitoring of the investigational item or service; the prevention of complications which may arise from the investigational item or service; and, reasonable and necessary costs arising from the provision of the investigational item or service, including those necessary for the diagnosis or treatment of complications.

What Clinical Trials Are Covered under the NCD?
Specific criteria for the qualification of a clinical trial under this decision are explicitly spelled out in the NCD. In order to be covered, a clinical trial must meet specific criteria.

1. The item or service provided in the trial must fall within an existing Medicare benefit category.
   
2. The trial must have therapeutic intent and not be designed to exclusively evaluate toxicity or disease pathology. This was an issue of serious concern in the negotiations with the Administration as the cancer community felt strongly that Phase I trials should not be excluded from the NCD. It is widely believed that this criteria will enable coverage of Phase I trials.
   
3. Beneficiaries participating in clinical trials designed for therapeutic intent must have been diagnosed with the specific disease the trial is designed to evaluate; healthy volunteers will not be permitted. Clinical trials designed to evaluate diagnostic interventions can enroll healthy volunteers in the control arm of the trial.
   
4. Clinical trials, both federally supported and privately funded, are deemed to qualify automatically under the provisions of the NCD as long as they are:
   
   1. Funded by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ), the Department of Defense (DoD), the Department of Veterans Affairs (VA), and HCFA.
      
   2. Supported by centers or cooperative groups that are funded by the aforementioned federal agencies.
      
   3. Conducted under an investigational new drug application (IND) filed with and reviewed by the Food and Drug Administration, thus clinical trials sponsored by the private sector are also covered under this decision.
      
   4. Drug trials that are exempt from having an IND. These trials are deemed to automatically qualify for a provisional period.
      
   
   
5. Clinical trials that are not automatically qualified will be measured against a set of criteria established by a multi-agency Federal panel. Once this group establishes the criteria all drug trials exempt from having an IND will be subject to this qualifying or certification process on a prospective basis; the criteria will not be applied retroactively.
   

Federal Panel
The AHRQ is instructed to convene a multi-agency Federal panel to develop qualifying criteria which will be applied to a clinical trial that is not automatically deemed to qualify in order to determine its eligibility for coverage under the NCD. The agencies that will participate in this process include the NIH, FDA, CDC, DoD, and VA. The proposed NCD which was issued for public comment on August 4, 2000 did not include the FDA in this process; the final NCD does include the FDA as a participant in this process.

Medicare Clinical Trials Registry
The NCD also provides for the establishment of a Medicare clinical trials registry to assist in the administration, payment and assurance of program integrity. Principal investigators of automatically certified trials must enroll the trial in the registry once it is established. Trials that must qualify through a certification process must be enrolled after the certification process.

The announcement and subsequent implementation of the NCD demonstrates the value of sustained involvement in the legislative and public policy process by patients, advocates and researchers. The issue of Medicare reimbursement for clinical trials is a policy initiative that many organizations have been working in support of since the early 1990’s in the Congress, the Administration, and the Federal agencies. Persistent efforts have enabled older Americans, who are disproportionately affected by cancer, to have access to cutting edge therapeutic options. It is vitally important that as this policy is implemented a careful evaluation occur and an ongoing dialogue with the relevant Federal agencies be sustained to assure that the NCD stays in sync with the state-of-the art of clinical cancer research.

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