CMS says a provision in recently passed Medicare legislation will allow more timely national coverage of preventive services.

Sec. 101 of the Medicare Improvements for Patients and Providers Act, which became law July 15, allows CMS to use the national coverage determination (NCD) process starting in 2009 to extend coverage to preventive services that are endorsed by the U.S. Preventive Services Task Force, such as screening tests and counseling.

"The NCD process is not without its hurdles, certainly," Ted Mannen, an attorney with the Washington, D.C., office of Epstein Becker & Green observed. "But I think for a manufacturer, there is a relatively marked pathway now for seeking coverage of a preventive service."

Previously, CMS only had the statutory authority to cover services that treat or diagnose a disease; it did not have the authority to cover preventive services. Instead, Congress has had to enable coverage for individual services through specific legislation.

For example, a law passed in 2006 allows Medicare coverage of one-time ultrasound screening for abdominal aortic aneurysms in at-risk beneficiaries (¹ 'The Gray Sheet' Feb. 13, 2006, In Brief).

Other covered preventive services include mammograms, and screening for diabetes, colorectal cancer and osteoporosis.

The unpredictability of the legislative process is a major challenge to a sponsor seeking coverage for its screening test, Mannen said. Screening bills usually need a legislative vehicle and must face scoring projections of the Congressional Budget Office so policymakers may need to find offsetting savings to fund new screening coverage.

In another significant change under the new law, the agency is granted explicit authority to take into account "the relation between predicted outcomes and the expenditures for such service," an authority not granted in the statute for coverage considerations of any other type of service.

Stakeholders can be frustrated with CBO scores that are not able to take into account downstream savings, such as avoided treatments for an illness that was prevented by the screening. Manufacturers and other sponsors will now be able to provide data to CMS to make a cost-effectiveness case for a screening test.

CMS At Work On Implementation Details

A CMS spokesperson told "The Gray Sheet" it expects the Sec. 101 process will require more staff resources, but will be quicker than the congressional pathway if the evidence for a service is supportive.

The agency is considering its options for implementing the new law and will work out details "in the very near future."

"Whether or not they're really going to open the door for preventive services or sort of crack it open and look with skepticism through it and raise serious barriers ... we're going to have to see," noted Gordon Schatz, at attorney with Reed Smith in Washington, D.C.

CMS has not said if it plans to automatically open national coverage analyses for USPSTF-recommended services or if it will wait for manufacturers or other sponsors to request coverage.

Only services given a grade of A (strongly recommended) or B (recommended) by the task force may be covered under the new pathway. CMS already covers all A-rated services for adults.

CBO's estimate that Sec. 101 will cost $1.4 billion over five years and $5.9 billion over ten years is based the assumption that, over the next three years, CMS will cover services with a USPSTF rating of B if it has not already done so.

Examples of non-covered services in that category include screening for obesity and depression.

CBO expects additional services will be covered in subsequent years as the task force makes new recommendations.

"That's a pretty rigorous analysis [USPSTF] puts technologies through," said Mannen. "It is a little more predictable I think than going through Congress, [but] it's certainly not without its rigor."

- Chloe Taft (c.taft@elsevier.com)

CMS Offers New Path To Coverage For Preventive Services

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