So that I am not always a taker but sometimes a giver: this is from my August issue. And if you absolutely can't read it I can send you a PDF of the whole thing.

CMS Clinical Trials Policy Revised Again;
Research Community Still Seeks Changes

The research compliance community is awaiting anxiously the results of a second go-round of revisions to the policy under which universities and others can bill Medicare for services provided to beneficiaries enrolled in clinical trials. Proper billing can bring in millions to the academic research community, but improper billing can lead to unwanted scrutiny by the Office of Inspector General and the Department of Justice.

On April 10, 2007, the Centers for Medicare & Medicaid Services, which runs Medicare, issued a proposed update to its 2000 clinical trials policy, and, following a 30-day comment period, was scheduled on July 10 to release the final policy.

But to the shock of many, CMS instead issued a final policy containing a tiny revision to the old policy and nine days later issued an entirely new proposed policy, or the mouthful that it called the "Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy, Renamed the Clinical Research Policy." CMS policies are formally called National Coverage Determinations. October 17 is the date on which CMS is scheduled to issue the final version of this second reconsideration.

According to comments made by Steve Purrough, CMS director of Medicare's coverage and analysis group, at an "open door forum" the agency held on the issue last month, this is also the date the policy will go into effect. But, it seems the new and improved proposed policy has engendered even more controversy and opposition than the original.

Deemed Status' Is Eliminated

Under the old policy, put in place under President Clinton, Medicare pays for certain items and services provided to beneficiaries enrolled in trials under certain conditions. Simplified, this means that trials that are federally funded, such as by the National Institutes of Health, or approved by the Food and Drug Administration or another federal agency, are already deemed to qualify as those that could receive payments for Medicare beneficiaries.

CMS said it wanted to update this policy to be more current and expand coverage in ways that it hoped would encourage more beneficiaries to enroll in a trial (see RRC April 2007, p. 8).

According to the July 19 second reconsideration proposal, "CMS received many comments stating that it appeared that the April 10, 2007 proposed decision would limit privately funded trials that were being paid prior to the announcement of that policy. This concern was based on an interpretation that the 2000 Clinical Trial Policy established a second path to Medicare coverage of items and services within federally funded trials, but did not restrict or otherwise affect Medicare coverage under privately funded trials."

"Because of this apparent confusion concerning the applicability of the 2000 NCD," CMS said, “we are proposing to set forth the scope of the policy by defining '“clinical research”' and renaming the overall NCD to include all clinical research. We are further proposing to replace the requirements for qualifying clinical trials with new standards that ensure that coverage for Medicare beneficiaries participating in research studies is consistent across all types of studies, including federally funded and privately funded trials."

CMS further described the purpose of the second reconsideration, saying, "We are also proposing to define the items or services that would be covered in qualifying clinical research to maintain consistency across the Medicare program (and making clear that coverage does not include administrative costs of the clinical research). In addition to ensuring consistency of wording, we are proposing a process that will allow study sponsors/principal investigators to certify to CMS that their study meets the standards described in this policy. This modification will ensure that all qualifying clinical research studies, whether publicly funded or privately funded, will be eligible for coverage under the final NCD."

Under the new draft, CMS said, it will cover "usual patient care for beneficiaries enrolled in clinical research studies in which the study sponsor/principal investigator has certified to CMS that the standards in this policy have been met."

Sponsors, Investigators Must Send CMS a Letter

CMS proposes that "study sponsors/principal investigators" would "send a letter to CMS describing the scope and nature of the clinical research, discussing each of the standards in this policy, and certifying that all standards in this policy have been met."

The following are the standards that have to be certified as having been met:
1. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants' health outcomes.
2. The research study 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.
3. The research study does not unjustifiably duplicate existing studies.
4. The research study design is appropriate to answer the research question being asked in the study.
5. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
6. The research study is in compliance with all applicable  federal regulations concerning the protection of human subjects found at 45 CFR Part 46. If a study is FDA-regulated, it also must be in compliance with 21 CFR Parts 50 and 56.
7. All aspects of the research study are conducted according to the appropriate standards of scientific integrity.
8. The research study has a written protocol that clearly addresses, or incorporates by reference, the Medicare standards.
9. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Studies of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life-threatening as defined in 21 CFR § 312.81(a) and the patient has no other viable treatment options.
10. The clinical research study is registered on the ClinicalTrials.gov website site by the study sponsor/principal investigator prior to the enrollment of the first study subject.
11. The research study protocol specifies the method and timing of public release of all pre-specified outcomes to be measured, including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer-reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors. However, a full report of the outcomes must be made public no later than three years after the end of data collection.
12. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
13. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability, or Medicaid eligibility.

Standards Prompts Many Questions

CMS is accepting comments on this proposed NCD until August 18. Most organizations that represent the research compliance community, including the Association of American Medical Colleges, develop their comment letters with input from their membership and send them to an agency on the comment date. RRC went to press before the comment period ended.

But RRC has learned through interviews with leaders in the research community that there are many objections to, at a minimum, the use of the standards, as well as the loss of deemed status.

As such, research groups may ask CMS to:

Retain the "deemed" status for federally funded studies:

Eliminate the publication within a certain amount of time requirement, as it will be difficult to know when data collection is done, and moreover, it requires certification of a “future” event.;

Allow a transition period between the issue and effective dates. During this transition period, perhaps as long as six months, researchers want the prerogative to choose which policy they will utilize (the 2000 one or the revised NCD);

Explain the term "existing studies" in the third standard to clarify how much research must be done on this before a study can be undertaken.  Organizations do not want to commit scarce funds and time to perform extensive literature or other searches to be in compliance with this standard.

Define what is meant by "scientific integrity" in the seventh standard. A common assumption might be that universities could refer to regulations overseen by the Office of Research Integrity, but CMS has not specified any agency as a reference point. ORI no longer even calls the issue "scientific" but "research" integrity.

Elaborate on who is supposed to know, and how, whether any subjects have yet been enrolled in order to meet the requirement that the trial first be registered. This could be a big problem for multicenter trials.

Clarify the misunderstandings in the 2000 policy for trials that are already ongoing.

Expert: Get Ready Now to Comply

It is unclear to what extent CMS can or will make changes in this latest draft NCD. It is difficult to imagine that the agency would issue a third reconsideration, but the extent of the objections over the second one may force it to look closely at how to proceed.

Regardless of what CMS may change from the second proposed NCD to the final, experts are recommending that compliance officers and investigators begin to plan now for how they might meet the standards and requirements.

"Investigators will need to be trained, and you should start thinking about that now," warned Debbie McAllister, an attorney and consultant in Willow Springs, Ill, who advises universities and academic medical centers on compliance with government programs, including Medicare.

"October 17th isn't that long away. I am also suggesting that my clients determine who in their institution is going to police this, who is going to make sure that these things get done. Their IRBs, which are always overworked, may be one place to start. The grants and contracts offices are definitely going to have to be involved," added McAllister, of Willow Springs, Ill.
Links: www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=210 and http://debbiemcallister.com/index.html (double click on items)




Kind regards,
Theresa Defino
Editor
AIS Report on Research Compliance
www.reportonresearchcompliance.com
xxxxxx@aol.com
301.738.3721



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