A commitment by CMS to redefine predisposition and predictive genetic tests as diagnostic lab tests could improve coverage of the technology, according to a ¹ SACGHS draft document.

The move would eliminate genetic tests from being defined as "screening tests," which are excluded from Medicare coverage unless mandated by Congress.

CMS could implement the policy either through a rulemaking process or a national coverage decision specifying that "genetic tests, in the presence of a strong family history of disease, are considered to be diagnostic tests," the report suggests.

However, the draft document, which was authored by staff of the Secretary's Advisory Committee on Genetics, Health & Society, acknowledges that "a compelling case for the uniqueness of genetic tests would need to be made to confine the applicability of these changes to genetic tests."

The draft cites CMS' focus on disease management, particularly in implementing the Medicare Modernization Act, as evidence that the agency could be receptive to an increased focus on prevention.

SACGHS has highlighted inadequate genetic test reimbursement as a major hurdle to widespread genetic test dissemination (² Also see "Genetic Test Reimbursement Issues Get Top Billing On SACGHS Priority List" - Medtech Insight, 8 March, 2004., p. 6).

SACGHS will discuss the draft report and make recommendations at its June 14 meeting in Bethesda, Md. The document proposes a variety of policy options, which the committee may elect to adopt. Public comments are due June 8.

Another policy option for improving genetic test reimbursement could be to task an HHS expert panel with clarifying and standardizing the evidentiary requirements needed to qualify for coverage, according to the draft.

While Medicare and private payors would not be required to adopt the guidelines, doing so "could have a far-reaching impact" on the coverage decision-making process for genetic technologies.

The report contends that the BlueCross BlueShield Association's Technology Evaluation Center (TEC) evidence guidance, which calls for "well-designed and well-conducted investigations" and technologies that "alter health outcomes," is "purposefully vague and ambiguous."

The TEC evidence criteria fail to identify how many genetic tests should be required to demonstrate clinical utility, the SACGHS draft says. In addition, it is unclear whether a genetic test that provides emotional relief should be considered an alteration of health outcomes, according to the report.

Genetic tests, as preventive services, can diagnose individuals at high risk for a disease before symptoms develop and allow them to minimize the severity of symptoms, resulting in future cost savings.

While Medicare and private payors do not explicitly factor cost into coverage decisions, the document suggests that considering future cost savings would add to the evidence supporting genetic test coverage.

"As long as cost is not explicitly considered in coverage decisions, making an argument for coverage of genetic technologies and services will remain challenging," the draft notes.

The document stresses, however, that payors must consider limited resources and should hesitate to pay for genetic tests with no available therapeutic options.

Since genetic tests often are used to inform reproductive choices and because most hereditary diseases occur before age 65, the report notes it may be preferable for private insurers - and not Medicare - to take the lead in determining coverage.

The draft also suggests that the CPT editorial panel could develop CPT code modifiers to permit more specific disease and gene identification for molecular diagnostic tests.

If codes inadequately describe the service being provided, providers often reject the claim even if the service would have been covered with more complete information. Genetic tests could become underused in cases where claims are repeatedly denied.

SACGHS also issued draft resolutions on direct-to-consumer marketing of genetic technologies and genetics education and training and a draft report describing the SACGHS priority-setting process.

SACGHS Plans To Develop Genetic Test Reimbursement Recommendations

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