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Convincing CMS to Reimburse Whole-Genome Sequencing Will be 'Challenging,' Official Says


By Bernadette Toner

Recent comments from a Medicare official indicate the Centers for Medicare & Medicaid Services has no plans to consider reimbursement for whole-genome sequencing-based tests any time soon.

The College of American Pathologists' Statline newsletter last month reported that Jeffrey Roche, head of the CMS Office of Clinical Standards and Quality Coverage and Analysis, described whole-genome sequencing as "probably something that CMS would never cover."

Roche made his comments at an Oct. 5 briefing on personalized medicine in Washington, DC, sponsored by Health Affairs and the Center for the Study of the Presidency and Congress.

In a follow-up statement that CMS provided for Clinical Sequencing News, Roche said that he regretted his choice of the word "never" with regard to the potential reimbursement timeline. "I should have said that I expected it would be very, very challenging to collect and analyze enough information to convince CMS that whole-genome sequencing should be covered by Medicare because of its value in helping physicians make patient care decisions."

Roche noted that his comments were "in the context of CMS' policy on coverage decisions, which depend on evidence that whole-genome sequencing actually makes a difference in patient outcomes."

Improved, clinically meaningful outcomes are "required for almost any new item or service seeking Medicare coverage," he said.

According to Roche's presentation slides for the briefing, which CMS provided for CSN, specific challenges that personalized medicine poses for Medicare coverage include the "effect of numerous genes in many diseases;" "deciding which genetic variants are deleterious and worth testing for, which are harmless, and which are uninformative;" and the question of whether physicians "understand how to use genetic and genomic tests for individuals."

Roche added that he doesn't believe that CMS "has made any exception for genetic testing to its usual policy about requiring evidence for coverage."

CMS did not provide further details about the agency's position on whole-genome sequencing.

While it may be some time before Medicare covers whole-genome sequencing-based tests, several developers in the clinical sequencing market have had some success in securing reimbursement from private payors for whole-genome and multi-gene tests based on next-generation sequencing.

Sequenom, for example, said last week that it has secured reimbursement for its sequencing-based MaterniT21 Down syndrome test from several undisclosed payors (see story, this issue). Likewise, two insurance companies have agreed to cover the Medical College of Wisconsin's clinical whole-genome sequencing program for children with rare, undiagnosed diseases (CSN 8/24/2011).

In addition, researchers at the Radboud University Nijmegen Medical Center in the Netherlands are conducting a 500-person pilot program designed to demonstrate that reimbursing for exome sequencing is more cost-effective than single-gene tests.

As part of the pilot project, Dutch insurance companies are reimbursing the test for €1,500 ($2,071) per patient (CSN 10/19/2011).

Have topics you'd like to see covered in Clinical Sequencing News? Contact the editor at btoner [at] genomeweb [.] com.

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