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Senate Legislation Would Streamline Complex Test Billing

NEW YORK (GenomeWeb News) – A bill was introduced into the US Senate yesterday that would make it possible for labs offering genetic and pharmacogenomic tests to bill Medicare directly.

The Patient Access to Critical Lab Tests Act (S. 1220), introduced Tuesday by Senator Arlen Specter (D – Pa.) and co-sponsored by Senator Ron Wyden (D – Ore.) proposes changing a section of the Social Security Act language concerning tests conducted on patient samples in order to allow specialized testing companies to bill Medicare rather than submitting a bill to a hospital, which would then bill Medicare.

The change would cut out a middle step in the billing that "discourage[s] hospitals from ordering revolutionary tests" such as pharmacogenomic and genetic tests, according to the Coalition for 21st Century Medicine, an advocacy group for new diagnostic technologies.

The act, which is a companion bill to one introduced in the House of Representatives in March, would benefit independent laboratories that develop and perform certain qualifying genetic, genomic or proteomic tests and cancer chemosensitivity assays," the coalition said.

"This bill will increase access to advanced diagnostic testing and allow the integration of genetics and genomics into medicine, in a 21st century paradigm, supplanting the archaic system that predates the maturing field of diagnostics available today," Sharon Terry, president and CEO of Genetic Alliance, said in a statement. "It’s about time we get hospitals out of the middle, and understand that medicine is about health, and requires innovation in process, products and delivery of services."

The House bill (HR 1699), introduced by Jason Altmire (D – Pa.), is aimed directly at making pharmacogenomic, genetic, and other complex diagnostic testing technologies more readily accessible to doctors.

The rule change would affect complex diagnostic tests that analyze DNA, RNA, chromosomes, proteins, or metabolites. These could include tests for gene expression, genotype, SNPs, chromosomal changes, cell response, and biochemical changes. However, it would not cover tests based on flow cytometry, immunohistochemistry, enzyme assays, or immunoassays.

The bill was written for tests developed and performed by labs that are independent of the hospital from which the specimen was collected.

According to the Altmire bill, "Genetic and molecular laboratory testing are the new cornerstones of high-quality, cost-effective preventative medicine." The bill states that personalized medicine "offers the promise of smarter, more effective, and safer care," and that some of the "most encouraging personalized medicine developments involve highly specialized laboratory tests."

The bill also blames "outdated Medicare regulations" for "obstructing access" to new diagnostics and predictive tests and "discouraging investments in development of new tests." The House bill calls for improved regulations that would encourage new testing technologies, and states that Medicare policies need to be written to "promote development of and access to" these complex tests.

The Specter version of the bill, which has not yet been posted by the Congressional Record, may contain differences from the House version in how it defines covered complex diagnostic tests, a spokesman for the Coalition for 21st Century Medicine told GenomeWeb Daily News, but it was not immediately clear what those changes entail.

Officials from Specter's office were not immediately available for comment.

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