Genetic Testing

H.R.493, S.358, the “Genetic Information Nondiscrimination Act of 2007,” would prohibit employers and insurers from misusing personnel genetic information.  This AACC-supported measure was signed into P.L. 110-233 by President Bush on May 21, 2008.

H.R.977, the “Genomic Research and Accessibility Act,” would ban the patenting of genetic materials.  The bill is prospective and does not apply to those patents already in existence.  The bill is sponsored by Representative Xavier Becerra (D-CA).  Similar legislation was introduced by former Representative Lynn Rivers (D-MI) in 2002.

S.736, the “Laboratory Test Improvement Act,” would increase federal oversight of laboratory developed tests (LDTs). If enacted, laboratories performing LDTs would need to register with the FDA, demonstrate the tests are comparable to other cleared or approved tests and submit information on the analytical and clinical validity of each LDT.  AACC has written to Senator Edward Kennedy (D-MA), the sponsor of the measure, to express its concerns about the bill.

S.976, the “Genomics and Personalized Medicine Act of 2007,” would expand and accelerate genomics research and lay the foundation for possible regulation of laboratory-developed tests.  The bill is sponsored by Senator Barak Obama (D-IL), who is a member of the HELP Committee, which has jurisdiction over this measure.  AACC has written to Senator Obama expressing reservations about the measure. 

H.R.6498, the Genomics and Personalized Medicine Act of 2008,” is the companion bill to Senator Obama’s measure.  The bill, sponsored by Rep. Patrick Kennedy (D-RI), would create a public registry for all genetic LDTs, promote ‘reasonable’ reimbursement rates for genetic tests and provide incentives for developing companion tests.  AACC is currently reviewing the measure.

S.605, the “Allied Health Professions Reinvestment Act,” would increase federal funding for allied health education and training, including medical technology programs. Supported by AACC and a number of other laboratory organizations, this legislation attempts to reverse the growing shortage of medical technologists, medical technicians, and other laboratory personnel. S.605 is sponsored by Senator Maria Cantwell (D-WA).

H.R.325, the “Standards to Provide Educational Achievement for Kids (SPEAK) Act,” would develop and promote voluntary math and science educational standards for students from kindergarten through grade 12.  This legislation is sponsored by Rep. Vernon Ehlers (R-MI).  AACC has endorsed the measure.

S.224, the “Standards to Provide Educational Achievement for Kids (SPEAK) Act,” introduced by Senator Chris Dodd (D-CT), would develop and promote voluntary math and science educational standards for students from kindergarten through grade 12.  AACC has endorsed the bill.

H.R.1634 & S.634, the “Newborn Screening Saves Lives Act,” would provide additional federal funds to educate parents and health care providers about newborn screening, improve follow-up care for infants with an illness detected through newborn screening, and help states expand and improve their newborn screening programs. This AACC endorsed measure was signed into P.L.110-204 by President Bush on April 24, 2008.

H.R.477, S.999, the “Stroke Treatment and Ongoing Prevention (STOP) Act,” would promote strategies to improve public awareness of the condition and reduce its incidence.  Currently, more than 700,000 American suffer a new or recurrent stroke and 150,000 die of the disease.  The House passed the H.R.477, introduced by Rep. Chip Pickering (R-MS), on May 27, 2007. The Senate has not yet taken action on S.999, sponsored by Senator Thad Cochran (R-MS). 

H.R.1321, the “Medicare Advanced Laboratory Diagnostics Act of 2007,” would refine the Medicare clinical laboratory fee schedule by requiring CMS to develop a new gap-fill process and establishing a demonstration project to evaluate a new Medicare payment system for molecular diagnostic tests.  Rep. Bobby Rush (D-IL) is the sponsor of the bill. 

H.R.1501, the “Medicare Laboratory Services Access Act of 2007,” would increase the Medicare laboratory specimen collection fee from $3.00 to $6.07. The fee, initially set in 1984, has never been updated in 23 years.   AACC has endorsed the measure, which is sponsored by Rep. Phil English (R-PA).

H.R.6761, the “Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008,” would create a negotiated rulemaking committee to redesign and modernize the laboratory payment system.  Rep. Bart Stupak (D-MI) is the sponsor of the bill.  AACC is currently reviewing the measure. 

S.3408, the Comparative Effectiveness Research of 2008,” would create a public-private entity to set national comparative research priorities, as well as allocate $500 million for evidence-based research over the next ten years.  Senator Max Baucus is the bill’s sponsor.  AACC has endorsed the legislation.