Congress routinely conducts hearings, initiates reports and enacts legislation of interest to clinical laboratories.  AACC actively participates in this process, meeting with congressional staff, attending hearings, and providing organizational and grassroots input on issues of concern to the association and the field.  Please check back periodically to learn about legislative measures of interest to the laboratory community introduced during the 112th Congress.

Key Legislation Introduced in 112th Congress

H.R. 436, the Protect Medical Innovation Act, introduced by Rep. Erik Paulsen (R-MN) (Senate companion, S.17, introduced by Senator Orrin Hatch (R-UT). The bill would repeal the $20 billion medical device excise tax in the 2010 health care reform law.

H.R. 452, The Medicare protection and Affordable Care Act, introduced by Rep. Phil Roe (R-TN). The legislation would repeal the health care reform statue that created the new Independent Payment Advisory Board (IPAB). Under the statute, the IPAB would be authorized to make cuts to Medicare if health care spending exceeded specified targets, but does not allow the legislative branch to prevent or curtail these cuts. AACC has endorsed this legislation.

H.R.3203, the Novel Device Regulatory Relief Act of 2011, introduced by Rep. Brian Bilbray (R-CA). The legislation would streamline the FDA medical device regulation process to make it easier for a manufacturer to submit a de novo petition. AACC has endorsed this legislation.

H.R.3207, Modernizing Laboratory Test Standards for Patients Act, introduced by Rep. Michael Burgess, MD (R-TX). H.R.3207 shifts sole responsibility for overseeing laboratory developed tests (LDTs) from the FDA to CMS. The bill would also create a new regulatory structure for LDTs under CLIA’88, including the introduction of new laboratory user fees.

S.660, Patient Act of 2011, introduced by Senator Jon Kyl (R-AZ). The bill protect patients by prohibiting the sole use of comparative effectiveness research (CER) to deny patient coverage of Medicare or Medicaid programs and to ensure CER accounts for differences in patient responses and preferences among subpopulations.

S. 1251, Medicare and Medicaid Fighting Fraud and Abuse to Save Taxpayer Dollars Act, introduced by Senators Tom Carper (D-DE) and Tom Coburn (R-OK). S. 1251 would give the federal government additional tools to fight waste and fraud in major health care programs, it would enact stronger penalties for Medicare fraud; help states identify and prevent Medicaid overpayments and deploy newest technologies to identify and prevent fraud.