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Subject:   Federal Guideline, if Enacted, Would Coerce Human Subjects into Clinical Trials Without Informed Consent
Date:   2005-05-25

The Centers for Medicare and Medicaid Services has published draft guidance for Coverage with Evidence Development (CED) that would require Medicare beneficiaries to enroll in research as a condition of coverage for certain new technologies or drugs. The draft guidance violates basic principles of informed consent. (1)

It appears that some Medicare beneficiaries are compelled to participate as a condition of coverage for Implantable Cardiac Defibrillators, anti-cancer and cardiovascular drugs. This violates the fundamental ethical principle that subjects must give voluntary informed consent: while the wealthy can choose to forego coverage rather than enroll, finances and fear of death constrain the decision of those with fewer resources.

On page 3, the draft guidance states the following:

The service is delivered in the context of specific data being collected. Coverage may be limited to providers who participate in and beneficiaries who are enrolled into a defined prospective data collection activity, when this data collection activity constitutes part of the evidence required to ensure the item or service provided to that patient is reasonable and necessary.

We find this recent statement by Dr. Stephen Hammill, MD to CMS about the ICD registry profoundly troubling:

It would be quite unfortunate to have the informed consent process become a major stumbling block to entering patients and thus preventing patients from receiving primary prevention ICD therapy and being followed in the registry. (2)

We disagree that the fundamental ethical principle requiring subjects give informed consent to participate in research is a stumbling block.

We disagree that the requirement for IRB approval of human research is an unresolved issue. Medicare regulations explicitly require compliance with federal regulations for the protection of human subjects as a condition of coverage. If this is a registry, IRB approval is required. Yet it cannot be a registry because CMS requires enrollment as a condition of coverage, and does so to determine whether ICDs will benefit certain patients. This constitutes research. In addition we point out that Dr. Sean Tunis and Dr. Mark McLellan, head of CMS, discussed ICD clinical trial participation as a condition of coverage in the New England Journal of Medicine in February, 2005. (3)

CIRCARE asks that CMS take notice of the consequences to Medicare beneficiaries as a result of guidelines that conflict with federal regulations for the protection of research subjects. We respectfully suggest CMS consult with the Office for Human Research Protections in this matter, and we ask that CMS clarify the draft guidance document on Coverage with Evidence Development (CED) before moving forward.

This guidance and putting into practice what's proposed raise serious concerns for the rights and welfare of research subjects – who are also called human beings. The Nuremberg Code, The Belmont Report, and The Common Rule all unequivocally state that voluntary informed consent of the subject is essential. We reject the idea that seriously ill patients compelled to become research subjects as a condition of Medicare coverage could give voluntary informed consent.

Elizabeth Woeckner MA, CIRCARE Board of Directors,

Michael A. Susko MS, President, CIRCARE
(410) 499-4895

Paul Gelsinger, Vice President, CIRCARE

Adil Shamoo, CIRCARE Co-Founder


1. Centers for Medicare and Medicaid Services. Draft Guidance for the Public, Industry, and CMS Staff: Factors CMS Considers in Making a Determination of Coverage with Evidence Development. Centers for Medicare and Medicaid Services web site. Available at:   http://www.cms.hhs.gov/coverage/download/guidanceced.pdf. April 7, 2005. Accessibility verified December 12, 2005.

2. Hammill S. Heart Rhythm Society written remarks to the CMS Council on Technology and Innovation. Centers for Medicare and Medicaid Services web site. Available at:   http://www.cms.hhs.gov/providers/cti/odfcomments214.pdf. February 14, 2005. Accessibility verified December 12, 2005.

3. McClellan MB and Tunis SR. Medicare Coverage of ICDs. N Engl J Med. 2005; 352:222-224. January 20, 2005.


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<a href="http://www.circare.org/im/im25May2005.htm">Federal Guideline, if Enacted, Would Coerce Human Subjects into Clinical Trials Without Informed Consent</a>. CIRCARE InfoMail (2005-05-25)

Last Updated: 2005-12-12

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