Bar Association Says Change Medicare Law to Cover Predictive Tests

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By John T. Aquino

Congress should change the definition of “medical necessity” to include tests that predict illnesses before they occur, the policy-making body of the American Bar Association said Feb. 6.

The ABA House of Delegates adopted a resolution at the midyear meeting in Miami to change the 50-year-old language of the Social Security Act so that it no longer excludes the predictive genomic testing that is the cornerstone of precision medicine.

The resolution would amend Section 1862(a)(1) of the Social Security Act (42 U.S.C. 1395y) that now says Medicare may not pay for any expenses that aren’t reasonable and necessary for the diagnosis or treatment of illness or to improve the functioning of a malformed part of the body. The ABA resolution would revise the definition, incorporating components such as the concept of testing for future illnesses using genomic medicine and interventions to prevent or mitigate against those illnesses or injuries. The resolution also urges the executive branch of government to adopt similar regulations.

“The importance of the ABA resolution is that it goes on the record,” John E. Steiner Jr., attorney, consultant and former associate general counsel and chief compliance and privacy officer for Cancer Treatment Centers of America, told Bloomberg BNA in a Feb. 6 phone interview. He noted there is a history of attempts to expand the statutory language concerning medical necessity based on various policy reasons. “The reason here is the growth of precision medicine,” Steiner said.

Definition of ‘Prognosis’ Added

The wording of the resolution is as follows: “That the American Bar Association urges Congress to amend Section 1862(a)(1) of the Social 2 Security Act (42 U.S.C. 1395y) and urges the Executive Branch to adopt regulations that broaden the scope of Medicare coverage by allowing for coverage for items and services that are reasonable and necessary: (a) for the diagnosis, prognosis or treatment of current or future conditions, illnesses, or injuries; or (b) to improve the functioning of a malformed or impaired body member or function; or (c) to mitigate against the future onset or severity of any prognosticated illness, injury or condition, taking into account supporting scientific evidence and evidence-based recommendations supporting their use.”

The resolution further said the American Bar Association urges Congress to define “prognosis” as forecasting the likelihood of or probable course of any current or future illness, injury or condition.

The House of Delegates made additions and no deletions to the resolution as proposed, adding the language on the executive branch adopting similar regulations, the need to take into account scientific evidence and evidence-based recommendations and the definition of prognosis.

Hopes for Commercial Spillover

The ABA resolution report by the ABA Health Law Section says it is the hope of its authors that the recommended language change in the statute “will also spill over to the commercial market,” noting that a major limiting factor to insurers covering predictive testing is the lack of industry standardization.

While a particular commercial insurer may be willing to invest in genetic testing and mitigating actionable therapies across insured populations to reduce the likelihood of future diseases, it may be reluctant to do so unless its enrolled lives stay with it over the long term, the resolution says.

“This is why a change in Medicare’s definition of medical necessity matters,” the report says. “As the government’s role in healthcare continues to grow, the lines between public payors and private payors have blurred.“More and more private payors base their coverage and reimbursement rates for services on what CMS [Centers for Medicare and Medicaid Services] defines as reimbursable under Medicare. Consequently, if Medicare adopts reimbursement methodologies that pay for prognostic tests and actionable therapies, it is our hope that more commercial insurers will follow.”

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

The adopted resolution is at http://src.bna.com/l0E

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