National Coverage Determination Requests Should Be Cost Blind – Cancer Rep

The Centers for Medicare & Medicaid Services should initiate national coverage determinations irrespective of cost, the Association of Community Cancer Centers said.

We "encourage the agency to dedicate its resources to addressing [access] concerns regardless of the item or the service cost," ACCC Policy & Government Senior Director Deborah Walter said during an open door forum.

"I think CMS appears to initiate NCDs, including the colorectal [cancer off-label] NCD, primarily out of concern for the cost of the item or service," she said.

The meeting was held to discuss the March 9 release of several documents including a ¹ draft guidance clarifying the factors that lead CMS to open an NCD.

A number of stakeholders have requested that CMS take steps to make the NCD process more transparent.

"We believe that CMS should provide more opportunity for transparency and public participation in the NCD process....I would like to recommend that in the future you all provide more information about the issues under review to help stakeholders monitor and participate in the NCD process up front," Walter said.

AdvaMed Associate VP-Payment & Policy Teresa Lee suggested that every item being considered for an NCD be posted on the website, along "with reasons for proceeding nationally."

The guidance states that the agency may list topics it is considering opening up for an internal NCD review on its website.

While publishing all potential NCDs would allow stakeholders to be more involved in the process, it also would serve to prevent manufacturers from being surprised by a national coverage review in instances where their competitor submits a request prematurely.

In comments on CMS' proposal for coverage of off-label uses for colorectal cancer drugs, the Pharmaceutical Research & Manufacturers of America and the Biotechnology Industry Organization both called for broader discussions of the agency's decision making (² (Also see "PhRMA Proposes New Compendia To Guide Off-Label Rx Coverage" - Pink Sheet, 10 Jan, 2005.), p. 17).

The guidance enumerates factors the agency considers in opening an internally-generated NCD including instances where it is necessary to clarify local coverage policies that are inconsistent or conflict with one another.

A national approach would also be taken in cases where local variation "is causing significant disparities in the care available to Medicare beneficiaries that are unlikely to be addressed effectively through provider training and education, or through the local coverage process," the document explains.

The language falls in line with CMS' authority under the Medicare Modernization Act to promote consistency of local coverage determinations.

CMS also may generate an internal request for an NCD when program integrity concerns have been raised, such as variation in billing practices, or when new evidence becomes available suggesting changes are warranted.

In addition, internal requests might be initiated when "significant questions about the safety, effectiveness, or obsolescence of currently covered" technologies are at issue.

Concerning new technologies, CMS may open a new NCD when "the health technology represents a substantial clinical advance and is likely to result in a significant health benefit if it diffuses more rapidly to all patients for whom it is indicated," the document states.

The agency also may meet with beneficiary groups, professional bodies and manufacturers to gauge whether to open an internal NCD.

CMS is soliciting comments on its criteria for opening an NCD, including "ways in which further useful details of the criteria could be specified."

Furthermore, the agency requests comments on "the most effective consultative process for alerting interested parties to potential NCD openings under consideration and for eliciting their input, keeping in mind resource limitations."

For external requests, the agency urges applicants to set up a preliminary meeting with CMS' coverage & analysis group staff to review data and to discuss any additional information needed for the review. Clinical trial protocols, if relevant, should be submitted.

The agency is requesting comments on how to make the interactive process in NCD development occur as efficiently as possible.

The other draft guidances issued by the agency explain the agency's criteria for referring an NCD to an external technology assessment review or the Medicare Coverage Advisory Committee.

According to the ³ tech assessment draft guidance, the agency will seek outside assistance when an extensive body of evidence is available and when formulating appropriate questions is difficult due to conflicting medical literature.

The guidance also stipulates that CMS will solicit an external tech assessment when the agency does not possess the clinical expertise to conduct the review, when specialized methods such as decision-modeling and meta-analysis are needed and when the decision will be referred to MCAC.

CMS will also request a tech assessment when timely agency review is not possible or extra unpublished, non-proprietary data could be gathered and evaluated.

CMS is seeking input on how stakeholders can assist in developing questions for external tech assessments and MCAC review, while still meeting NCD timelines.

"Getting those questions formulated is the most important part of the tech assessment and the MCAC process, and if we do that with a lot of public input, we are unsure as to how we are going to meet our [nine-month] timelines," CMS Coverage & Analysis Director Steve Phurrough said.

According to the ⁴ MCAC draft guidance, national coverage determinations will be referred to the advisory committee in cases where the topic is controversial or when published studies have failed to address policy questions, contain substantial methodological flaws or show conflicting results

An NCD will also be referred to the MCAC in cases where the agency would like further expert review of the methods used in the tech assessment.

Additionally, the advisory committee will convene in instances where CMS would like additional public input on a technology's net health outcomes where varying interpretations exist; when widespread use of a technology could significantly affect the Medicare program; and when the agency could benefit from patient advocacy input and broader societal perspectives.

The ACCC believes the agency should accept stakeholder input on whether to use either the MCAC or an external tech assessment in conjunction with an NCD.

"CMS should also make its decisions regarding these reviews more transparent, particularly when CMS proposes to use an NCD to gather evidence about an item or service," Walter said.

The document is intended to incorporate MCAC's evolving role from evaluating specific requests to "predicting some of those issues we think may result in an NCD in the future and asking MCAC to comment on the evidence," Phurrough noted.

Supporting the push for transparency, AdvaMed's Lee stressed that if MCAC will be used "to engage the public on matters of controversy, it should consider means to promote increased public dialogue and consideration at MCAC meetings."

She added that "current MCAC processes are tailored towards evidence evaluation in full public view, not broad public participation."

Comments on the guidance are due May 8. Because of the one-day notice stakeholders were given to review the documents before the forum, relatively few stakeholders presented at the open door forum. Over 320 stakeholders listened in, however.

The agency also plans to release a draft guidance on its nascent policy of linking coverage to data collection later this month (⁵ (Also see "CMS Developing Guidance On Coverage Decisions For Clinical Trials" - Pink Sheet, 17 Jan, 2005.), p. 12).

A guidance on how CMS reviews evidence for determining whether or not a product or service is reasonable and necessary and a guidance on sector-specific documents are in development.