CMS Issues Draft Guidance on Medicare’s National Coverage Determination Process

For many years, the national coverage determination process ("NCD") followed by the Centers for Medicare and Medicaid Services ("CMS") was shrouded in secrecy, and notorious for being painstaking slow. In recent years, CMS has taken some steps to open the NCD process to the public, and to be more transparent about making NCDs.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("MMA"), however, has made significant changes to the NCD process, designed to improve it for new technology, and also make more transparent. Under Section 731 of the MMA, the Secretary of Health and Human Services ("HHS") is required to make public the factors considered in determining whether an item or service is reasonable and necessary, and to develop guidance documents.

Pursuant to these MMA provisions, on March 9, 2005, CMS published the first three drafts in a series of guidance documents entitled (i) Factors CMS Considers in Opening a National Coverage Determination; (ii) Factors CMS Considers in Referring Topics to the Medicare Coverage Advisory Committee; and (iii) Factors CMS Considers in Commissioning External Tech- nology Assessments. These draft documents are available on the CMS Web site at http://www.cms.hhs.gov/coverage/ guidance.asp. Comments on the draft guidance documents must be received by CMS no later than May 8, 2005.

CMS plans to issue additional guidance documents related to NCDs and requests assistance from the public in prioritizing topics for future guidance. Other guidance documents under development include CMS' approach in evaluating the scientific information submitted with the NCD request, and the medical and scientific information which constitutes adequate evidence to support an NCD development.

An NCD is a determination by the Secretary of the HHS regarding whether a particular item or service is covered under Medicare. CMS' Coverage and Analysis Group ("CAG"), in the Office of Clinical Standards and Quality, is responsible for the development of NCDs, which apply to Medicare beneficiaries nationwide. An NCD is binding on all Medicare contractors, Medicare Advantage (formerly Medicare+Choice) Plans, quality improvement organizations, and Administrative Law Judges.

This guidance document explains the initial step of the NCD process, and what CMS considers to be a complete, and formal request necessary to start the formal review process.

Prior to Initiation of an NCD. A party who in interested in the submission of a formal request for an NCD may contact CMS on an informal basis to seek advice on how to request an NCD, and the type of information to be submitted. CMS also encourages preliminary meetings with interested parties, either in person or by teleconference, to review, for example, the requestor 's clinical trial data and supporting documentation related to the request. During these preliminary meetings, CMS may, in turn, initially evaluate supporting documentation presented by the requestor. CMS specifically seeks comments on how to maximize the efficiency of this critical interactive process in the request for an NCD.

CMS explains that any party (e.g., manufacturers, suppliers, providers, medical professional organizations, and Medicare beneficiaries) may initiate a request for an NCD. A Medicare beneficiary who is an "aggrieved party" i.e., a Medicare beneficiary who is in need of the item or service at issue, may also request an NCD. However, an aggrieved party request is subject to more stringent statutory timeframes. In addition, CMS may itself generate a request for an NCD (e.g., when controversy exists about the clinical benefit of a procedure or device). The guidance also specifically seeks comments on (1): the criteria for requesting an NCD; and (2) the most effective process to alert interested parties to potential NCDs under consideration and to elicit their input.

What Constitutes a Complete, Formal Request for an NCD? A formal request for an NCD must: (1) be submitted electronically (unless there is good cause to submit a hard copy); (2) identify the request as a "Formal Request for an NCD"; (3) state the benefit category or categories of the Medicare program to which it applies (e.g., diagnostic tests, durable medical equipment); and (4) include adequate supporting documentation with the formal request letter.

Once CMS has determined that the request is adequately supported, it will accept the request and post the acceptance on its Web site under the list of pending coverage issues. Interested parties may monitor the status of the NCD process on the Web site and may submit comments to CMS. CMS explains that the posted tracking sheets are a "key element in making our NCD process more efficient, open, and accessible to the public".

In the course of CMS' review of an NCD request, the agency may refer the matter to the Medicare Coverage Advisory Committee ("MCAC"). The second guidance document explains the factors CMS considers to refer to the MCAC in order to obtain independent, expert advice and public input on specific clinical topics. An MCAC referral extends the timeline for completing an NCD from six months after the date of a formal request (when a MCAC referral is not required) to nine months when CMS refers a matter to the MCAC.

The MCAC does not specifically advise CMS whether to cover an item or service. Rather, it reviews medical literature, technical assessments, and other information on the clinical effectiveness of a medical item or service, and advises CMS if there is sufficient evidence to indicate that a particular item or service leads to an appropriate health outcome.

The MCAC is comprised of a maximum of 100 members appointed by the Secretary, including six nonvoting consumer representatives and six non-voting industry representatives. No more than 15 members may serve at any one meeting, including one consumer representative and one industry representative. The selection of members for a particular meeting is based on the members. experience related to the specific topic under review.

Criteria for Referral to the MCAC. CMS may refer an issue to the MCAC under various circumstances, including when: (1) the issue is the subject of a scientific, medical or public controversy; (2) the issue has the potential to have a major impact on the Medicare population or the Medicare program; and (3) existing published studies show conflicting results or contain significant potential flaws in the protocol methodology.

The MCAC Process. The MCAC conducts four to six public meetings per year, and interested parties have the opportunity to attend such meetings and present their views. CMS publishes a notice in the Federal Register approximately 30 days before each meeting. Following a presentation by CMS and public testimony, the MCAC members publicly discuss the issues. CMS posts the official transcript and executive summary on its Web site, generally, within 30 days of the meeting.

This guidance document explains the factors CMS considers when determining when to commission an external Technology Assessment ("TA") to evaluate the risks and benefits of a health care technology. In addition to the MCAC process, during the NCD process, CMS may determine that a TA is required. A TA also extends the timeline for completing NCDs. The six month timeframe for NCD decisions is extended to nine months when CMS requests a TA.

A TA provides an independent, systematic analysis of the safety, efficacy and effectiveness of a health care technology by an independent contractor. The key component is the interpretation and critical evaluation of the evidence on patients' health outcomes. The performance of a systemic review of the medical literature, therefore, forms the core of every TA.

Criteria for Requesting an External TA. CMS may request an external TA under various circumstances, including when: (1) the body of evidence to review is extensive, thereby making it difficult to complete an internal technology assessment within the statutory timeframe; (2) there are significant differences in opinion among experts concerning the relevant evidence or in the interpretation of data; and (3) the complexity of the subject requires analyses beyond the scope of CMS' staff expertise (e.g., to utilize specific review methods such as meta-analysis).

The External TA Process. CMS has an agreement with HHS' Agency for Healthcare Research and Quality ("AHRQ") to perform, as appropriate, TAs. TAs may be performed internally by AHRQ staff, may be done in collaboration with an AHRQ's evidencebased practice center, or AHRQ may utilize another qualified entity. CMS specifically requests public comments on the role stakeholders might play in the TA design, including the assessment questions to be addressed by the TA.

A final TA will generally include: (1) the final assessment questions and TA framework; (2) a summary of the literature search strategy, with a copy of the articles reviewed; (3) a "peer-review- ready" draft report; and (5) a final TA report. Requests for a TA can be tracked on the CMS Web site, and the final TA is also posted on the CMS Web site.

The ultimate goal of the coverage process is to provide Medicare beneficiaries with prompt access to new items and services that qualify for Medicare coverage, if there is a clear medical benefit. The guidance documents may help CMS to better achieve this goal by speeding the development of NCDs and providing developers of medical technology with a clearer understanding of the Medicare coverage process.

If you would like more information regarding these guidance documents or the Medicare coverage process, please contact Denise Rios Rodriguez or Mary Ellen Allen in our Los Angeles office, Lisa Acevedo or Fred Entin in our Chicago office, Chris Rossman in our Detroit office, Maria Gonzalez Knavel in our Milwaukee office, Diane Racicot in our San Diego office, Mike Scarano in our San Diego/Del Mar office, Judith Waltz in our San Francisco office, Lena Robins in our Washington, DC office, or the member of the firm who normally handles your legal matters.

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