On July 10, 2006, CMS opened a reconsideration of its national coverage determination on clinical trials. The purpose of the reconsideration is to further refine the policy to rename it the Clinical Research Policy (CRP). to address several ambiguities, including the link between the CRP and the Coverage with Evidence Development concept, and the authority to allow the Agency to pay for the costs of limited investigational items. Further information is available at http://www.cms.hhs.gov/ClinicalTrialPolicies/
NCA for Clinical Trial Policy (CAG-00071R). Available from http://www.cms.hhs.gov/mcd/viewnca.asp?from=ncd&nca_id=186
NCA Tracking Sheet for Clinical Trial Policy (CAG-00071R). Available from http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=186
Public Comments on Clinical Trial Policy (CAG-00071R). Available from http://www.cms.hhs.gov/determinationprocess/downloads/id186.pdf
Electronically Submitted Public Comments on Clinical Trial Policy (CAG-00071R). Available from https://www.cms.hhs.gov/mcd/viewpubliccomments.asp?id=&cov_id=&state_id=&list_type=&goto=viewpubliccomment&nca_id=186
Related: CMS Announces Reconsideration of Clinical Trial Billing Policy. McDermott Newsletters. McDermott, Will & Emery. 2006-07-25. Available from http://www.mwe.com/index.cfm/fuseaction/publications.nldetail/object_id/0302e6a2-2547-48cc-a820-0b28a3a96bb1.cfm
The following are selected highlights from Medicare's Final National Coverage Decision on Clinical Trials.
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.
Source: Final National Coverage Decision on Clinical Trials. Medicare Coverage, Clinical Trials, Centers for Medicare and Medicaid Services. Accessed on 2005-09-02 at: http://www.cms.hhs.gov/ClinicalTrialPolicies/Downloads/finalnationalcoverage.pdf
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 or intervention.
Medical devices are another matter. Ask point blank who is expected to pay for the device and how much; if your co-insurance (Medigap) is expected to cover the cost, confirm it with them. Inspect the consent form carefully to make sure you understand whether or not there is any cost to you. To avoid unpleasant surprises, unless the consent form contains an explicit statement like There is no cost to you if you decide to enroll in this trial,
it's prudent to ask if you'll be expected to pay anything and how much. Ask for clarification of costs if they aren't clearly spelled out in the consent form. You shouldn't feel shy about asking for clarification because federal regulations require this information be disclosed during the process of informed consent and documented in the consent form. What's more, the regulations require this information be provided to you in such a way that you understand it. Put differently, if you don't understand something or if information is missing, it's the researchers' fault, not yours.
If you're thinking about enrolling in research, read AARP's articles for seniors considering research participation:
8 Questions to Ask Before You Sign up for a Clinical Trial. AARP Bulletin Online. June, 2003. Accessed on 2006-11-02 at http://www.aarp.org/bulletin/yourhealth/Articles/a2004-10-18-8questions_clinicaltrials.html
Assessing the Risks, Benefits of Clinical Trials. Beth Baker. AARP Bulletin Online. June, 2003. Accessed on 2006-11-02 at http://www.aarp.org/bulletin/yourhealth/Articles/a2003-07-11-clinicaltrials.html
The National Cancer Institute (NCI) has a free brochure for Medicare beneficiaries considering research participation. Overall this is a very good straightforward source of answers to basic questions about clinical research participation. NCI should be commended for providing information that people can read and comprehend without a pile of dictionaries.
We take serious exception, however, to the 2nd item in the list of suggested questions prospective research subjects should ask prior to enrollment. In question No. 2 (page 4), NCI suggests you ask How will it help me?
With all due respect to NCI, this is misleading because it implies there is data to suggest that enrolling in research will help your medical condition. In reality the purpose of the clinical trial is to determine if the research intervention is beneficial for you. The over-arching purpose of research is to extend general knowledge: if clinical trial participation cures or otherwise ameliorates your medical condition, while it's nice, it's also incidental. Put differently, the purpose of a clinical trial is not to provide direct medical benefit to research subjects.
The NCI Medicare brochure can be downloaded at: http://www.cancer.gov/PDF/cfdd0c36-eb4e-466b-8c78-d18a4f8ac91a/ifyouhavecancer.pdf
If you prefer you can order it by mail here:
Centers for Medicare and Medicaid Services Clinical Trial Coverage Policies Main Page. Available from http://www.cms.hhs.gov/ClinicalTrialPolicies/
Medicare Fact Sheets. The Kaiser Family Foundation Medicare Policy Project. Available from http://www.kff.org/medicare/factsheets.cfm
Last Updated: 2006-11-07
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