Washington Editor
WASHINGTON - A bill to prohibit employers and insurance companies from discriminating because of an individual's genetic makeup is continuing to move through the House of Representatives, with an Energy and Commerce subcommittee approving it last week.
That's the latest hurdle for the legislation, which has always stalled in the past. Still, the measure must clear three panels before it reaches a floor vote in the House. Already the Education and Labor Committee has approved it, and the recent subcommittee endorsement would seem to signal pending success before the Energy and Commerce Committee. Action before the Ways and Means Committee has yet to begin.
The bill, the "Genetic Information Nondiscrimination Act," or H.R. 493, was introduced by Rep. Louise Slaughter (D-N.Y.). It establishes protections against using someone's genetic information in making decisions about health coverage or jobs.
Advocates such as Francis Collins, director of the National Human Genome Research Institute, have testified that without such protections the full potential of genomic research and personalized medicine may never be realized.
A companion bill sponsored by Sen. Olympia Snowe (R-Maine), S. 358, cleared the Senate's Health, Education, Labor and Pension Committee in January. Sharon Terry, president and CEO of the Genetic Alliance, said the Senate is soon expected to bring it to the floor for a vote. Twice before, in 2003 and 2005, the Senate has unanimously passed it, but the House has never voted on the matter.
This year's progress in the House represents a reversal of previous years, when opposition from large employer groups held up any advances. Of note, President Bush has voiced his support for such legislation.
CMS Looking Into EPO Usage
The Centers for Medicare & Medicaid Services (CMS) last week said it would review all Medicare policies on erythropoiesis-stimulating agents in the wake of the FDA's new black box warnings on the anti-anemia products, and encourage physicians to take the warnings into account when prescribing them.
In addition, CMS is continuing to review its erythropoietin monitoring policy for end-stage renal disease patients who undergo dialysis and has opened a national coverage analysis on the use of the drugs - Aranesp, Epogen and Procrit - for conditions other than end-stage renal disease, a first step toward issuing a national coverage determination.
Those drugs are approved to treat anemia in chronic kidney failure patients and cancer patients whose anemia is caused by chemotherapy, as well as HIV patients using zidovudine and to reduce the number of transfusions in patients scheduled for major surgery, except heart surgery.
The FDA's Oncologic Drugs Advisory Committee is meeting May 10 to further discuss EPO drug issues.
New Bill Aimed At SOX Reform
New legislation has been introduced to reform certain provisions of Section 404 of the Sarbanes-Oxley Act to make compliance more efficient, reducing some of the financial burdens on small- to mid-cap businesses in attesting to the soundness of their internal control functions.
Called the "Compete Act of 2007," or H.R. 1508, its primary sponsor is Rep. Gregory Meeks (D-N.Y.). It seems to follow proposed changes from the SEC, which late last year suggested that auditing standards should be eased for such companies, which have for some time called for scaled reforms to Section 404.
Companion legislation, S. 869, has been introduced by Sen. Jim DeMint (R-S.C.).
