This Week: Congress averts government shutdown by passing two-week extension for Continuing Resolution, pushing the funding issues to Dec. 21.


Bipartisan, Bicameral Legislators Unveil FDA-Inspired Bill Regulating Diagnostic Tests

On Dec. 6, bipartisan House and Senate members released draft legislation for the Food and Drug Administration (FDA) to regulate in vitro clinical tests, including test kits and laboratory-developed tests (LDTs). The draft legislation resembles a legislative proposal put forward by the FDA in August.

The bill establishes a precertification program for lower-risk tests, where the FDA could establish standard validity requirements for non-novel, lower-risk tests. Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) and Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced the bill, prioritizing the legislation in the 116th Congress.


Grassley, Wyden Introduce “The Right Rebate Act”

On Dec. 4, the incoming Senate Finance Committee chair Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) introduced “The Right Rebate Act of 2018,” a bill to recoup Medicaid rebates from drug companies that misclassify drugs. Grassley and Wyden’s new bill would give HHS more power to recoup the full amount lost if companies misclassify their products in the future. It also would give HHS the ability to directly modify a drug’s classification, which HHS cannot currently do. The legislation is based on recent events related to the misclassification of a popular anti-allergy medicine as a generic instead of a brand-name product. That incorrect classification allowed the manufacturer to pay smaller rebates to states and government programs.

The bill also would let the government fine companies up to twice the amount in rebates they avoid by misclassifying brand drugs as generics, allow the Centers for Medicare and Medicaid Services (CMS) to suspend Medicaid coverage of drugs that companies refuse to reclassify and give the CMS power to force classification changes.

Read more about healthcare policy on the McGuireWoods Consulting website.