Medicare Coverage of Clinical Trials

Draft

new It appears that Medicare has a new policy whereby beneficiaries seeking reimbursement for certain drugs, especially expensive drugs, will be required to enroll in clinical trials as a condition for reimbursement. To the extent that reimbursement might constitute coercion, this policy may be flawed; at minimum, clarification is necessary. For now, beneficiaries should consult with their licensed primary care physician to determine if enrollment in a clinical trial is in their best medical interest. The New York Times article below provides some rudimentary information about the policy.

Medicare Covers New Treatments With a Catch
Gina Kolata, The New York Times, 2004-11-05
URL: http://www.nytimes.com/2004/11/05/health/05medicare.html?pagewanted=print&position= [requires free registration required]

As of 2000-09-19, Medicare beneficiaries are eligible for coverage or reimbursement if they choose to participate in clinical trials, subject to specific restrictions. Roughly speaking, provided the clinical trial meets Medicare's requirements (some of which follow below), beneficiaries can expect coverage or reimbursement of everything Medicare would usually provide for except for the cost of investigational drugs, devices, or interventions. Don't panic about this exclusion: many, if not most, of the trials Medicare will pay for don't charge research subjects for the investigational drug, device, or intervention. Be sure to ask about this if it isn't clear from the informed consent.

These are selected highlights from the CMS Final National Coverage Decision on Clinical Trials; please consult the Center for Medicare Services at the links below for comprehensive information.

Requirements for Medicare Coverage of Routine Costs
Any clinical trial receiving Medicare coverage of routine costs must meet the following three requirements:

The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent.
Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.

The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs. Clinical trials also should have the following desirable characteristics; however, some trials, as described below, are presumed to meet these characteristics and are automatically qualified to receive Medicare coverage:

The principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes;
The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use;
The trial does not unjustifiably duplicate existing studies;
The trial design is appropriate to answer the research question being asked in the trial;
The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;
The trial is in compliance with Federal regulations relating to the protection of human subjects; and
All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

Medicare will cover the routine costs of qualifying trials that either have been deemed to be automatically qualified or have certified that they meet the qualifying criteria unless CMS's Chief Clinical Officer subsequently finds that a clinical trial does not meet the qualifying criteria or jeopardizes the safety or welfare of Medicare beneficiaries.

Should CMS find that a trial's principal investigator misrepresented that the trial met the necessary qualifying criteria in order to gain Medicare coverage of routine costs, Medicare coverage of the routine costs would be denied under 1862(a)(1)(E) of the Act. In the case of such a denial, the Medicare beneficiaries enrolled in the trial would not be held liable (i.e., would be held harmless from collection) for the costs consistent with the provisions of 1879, 1842(l), or 1834(j)(4) of the Act, as applicable. Where appropriate, the billing providers would be held liable for the costs and fraud investigations of the billing providers and the trial's principal investigator may be pursued.

Read more:
Final National Coverage Decision on Clinical Trials Medicare Coverage, Clinical Trials, Centers for Medicare and Medicaid Services
Medicare Coverage Routine Costs of Beneficiaries in Clinical Trials HCFA Fact Sheet 19 September 2000 pdf icon

Get more Information:
Medicare Coverage of Clinical Trials Centers for Medicare and Medicaid Services

You should be clear about what this does and does not do: Coverage of clinical trial participation may constitute a benefit in that it offers access to drugs or devices which may have been unavailable to Medicare beneficiaries or might have been unaffordable. Clinical trial participation may or may not be beneficial for you. While everyone hopes a trial will show that the test article is safe and effective, or safer and more effective than the comparator, not all trials do. A number of trials demonstrate that the test drug or device is less effective or produces more adverse effects. Try to keep in mind that the purpose of a clinical trial is to prove (or disprove) the null hypothesis — e.g., that drug A is safe and effective, or safer and more effective than the comparator. The purpose of a clinical trial is not to provide you a medical benefit: if that happens, while it's nice, it's incidental. Put differently, the goal of research is to increase general knowledge, not make you better. If you're considering research participation, remember that the person best qualified to help you decide whether or not to enroll in a clinical trial is your primary care physician.

It's worth remembering that Medicare reimbursement or coverage does not mitigate the inevitable risk of research participation. And just like the sections of the Code of Federal Regulations that apply to federally funded research and research with products regulated by the FDA, the Medicare regulations do not create any rights for Medicare recipients who enroll in Medicare reimbursable clinical trials. By setting out these guidelines, Medicare is describing conditions for reimbursement. And while it's surely welcome that these conditions meet some notable ethical guidelines, if you are injured or killed by accident, misconduct, stupidity, or fraud, these regulations do not confer any right to redress upon you or your survivors. Rather they grant Medicare a remedy, namely to seek return of funds paid for your participation in research that did not comply with the guidelines for reimbursement (e.g., the clinical trial failed to comply with The Common Rule or FDA regulations). Since Medicare uses the False Claims Act, with its unpleasant triple damages, to recoup funds paid out upon submission of claims that are discovered to be false, the protection of your rights and welfare as a clinical trial participant depends, in part, on the idea that the threat of prosecution might scare clinical investigators into complying with The Common Rule or FDA regulations. Whether or not this amounts to meaningful protection of human beings in research is anyone's guess, but it's certainly better than nothing.

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Last Updated: 2004-11-05