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Congress

April 26, 2007 | Daily News

Senate Finance Committee Chair Max Baucus (D-MT) is crafting a bill to inject more transparency into the Medicaid 1115 waiver process, Inside CMS has learned. A GOP aide said the committee's top Republican, Sen. Charles Grassley (IA), "shares an interest" in revamping the process.

April 25, 2007 | Daily News

Senate Finance Committee Chair Max Baucus (D-MT) has indicated that future war supplemental bills will remain the vehicle for an SCHIP shortfall fix if the White House follows through on its pledge to veto the initial version of the bill next week over issues unrelated to the children's health insurance language.

April 25, 2007 | Daily News

OSHA announced yesterday it will start inspecting microwave popcorn makers where workers face the highest risk of exposure to a chemical linked to "popcorn lung disease," but was immediately criticized by key Democrats and unions for not taking more aggressive steps to prevent worker exposure to diacetyl.

April 25, 2007 | Daily News

Sen. Orrin Hatch (R-UT) wants to introduce next week stand-alone biogenerics legislation requiring clinical trials for follow-on biologics and giving brand biopharmaceuticals market protections similar to those in Europe -- and is hinting at user fees. Hatch said Wednesday (April 25) he would like to introduce the bill before an omnibus FDA reform/user fee bill hits the Senate floor, but a Hatch staffer said several health committee members would vote against the FDA bill were it amended with biogenerics.

April 25, 2007 | Daily News

Congress stripped from a war supplemental amendment on Monday night language that would have increased the amount of rebates drug makers give to state Medicaid programs and agreed to extend Wisconsin's SeniorCare program -- currently on CMS' chopping block -- for two-and-a-half years.

April 24, 2007 | Daily News

Democratic lawmakers are resuming their press to expand services for the most high-cost and chronically ill beneficiaries covered under Medicare. House Energy & Commerce member Gene Green (D-TX) and Senate Finance member Blanche Lincoln (D-AR) are working on a modified version of legislation they introduced last Congress that would allow Medicare reimbursement for geriatric assessments and chronic care management.

The bills are a variation on a theme of treatment pushed by President Clinton, called Primary Care Case Management, proposed during his first term in office.

April 24, 2007 | Daily News

House appropriators last week blasted a provision of the 2008 White House budget proposal that would eliminate funding for a health program targeting urban-dwelling Native Americans, indicating they will push legislation to prevent the cuts if necessary.

Under the president's proposal, the Urban Indian Health Program (UIHP), which will receive nearly $33 million in fiscal 2007, would get no federal funding in fiscal 2008.

April 24, 2007 | Daily News

A House Energy and Commerce lawmaker is drafting legislation giving FDA authority to recall food, fine companies, mandate food safety standards similar to those imposed on the meat industry, and treat bacteria such as E. coli and salmonella as "adulterants" under food law.

Rep. Jay Inslee (D-WA) mentioned the bill during a House Energy and Commerce oversight subcommittee hearing Tuesday (April 24) on food safety. FDA officials did not testify, but FDA Office of Regulatory Affairs officials will testify at a second food safety hearing in May.

April 24, 2007 | Daily News

An aide to Sen. Charles Grassley (IA) said Tuesday the Finance Committee's top GOP member does not support a compromise provision included in the emergency war supplemental bill that would delay by one year CMS' controversial rule cutting back state Medicaid payments. The comments came a day after Sen. Richard Durbin (D-IL), who was pushing for a two-year delay, said he struck a one-year compromise with Grassley, who had advocated a six-month postponement.

April 23, 2007 | Daily News

Three House Democrats late last week introduced a bill giving FDA new authority to approve biogenerics, but wrote the bill in such a way as to hamstring the agency's ability to use such authority while also ratcheting back what FDA can approve under current law.

April 23, 2007 | Daily News

Editors' Note: The original online version of this story said Sen. Charles Grassley was part of the deal reached with conferees, based on information Inside CMS received from Sen. Richard Durbin. Durbin later clarified that he had merely suggested to Baucus that Grassley be a part of the negotiation process and had actually never personally met with the Iowa senator or his staff. Grassley aides confirm he was not involved in the compromise, and still objects to the amendment (see related story).

April 20, 2007 | Daily News

Senate Finance Committee members Gordon Smith (R-OR) and Jeff Bingaman (D-NM) last week dropped several pieces of legislation that aim to hike the number of low-income seniors enrolled in Medicare Part D.

April 20, 2007 | Daily News

Senate Aging Committee Ranking Republican Gordon Smith (OR) Wednesday asked the Congressional Research Service to conduct a 50-state survey to help Congress determine what role the federal government, states and industry should play in regulating pharmacy compounding of so-called "bioidentical" hormones. He also called for stronger enforcement by FDA and the Federal Trade Commission of compounders that continue to make health claims and market bioidenticals.

April 20, 2007 | Daily News

The Senate health committee tucked into the FDA reform bill it passed this week a measure subjecting state-legalized medical marijuana to FDA regulations. However, a group supporting medical marijuana says the legislation may not be enforceable.

Sen. Tom Coburn (R-OK) offered the measure as an amendment during mark-up of the FDA reform/drug user fee bill. Many Democrats objected, but enough voted for it to pass.

April 20, 2007 | Daily News

House and Senate leaders will meet Monday (April 23) to hash out differences surrounding their emergency 2007 spending bills -- including approximately $750 million to plug SCHIP deficits this year -- but observers are already looking further ahead, as a promised presidential veto leaves in question how Democrats will move the legislation before states are forced to dip into Medicaid or cut kids' coverage.

April 19, 2007 | Daily News

Several amendments by GOP members to narrow the scope of proposed FDA's authorities failed or were withdrawn during a marathon Senate health committee markup of sweeping FDA reform and user fee legislation Wednesday (April 18). The amendments, or new versions of them, are likely to reemerge during the upcoming Senate floor debate.

April 19, 2007 | Daily News

Senate health committee Chair Edward Kennedy (D-MA) is working to strike a deal on biogenerics legislation before the FDA reform/drug user fee bill is taken up by the full Senate. Kennedy circulated a draft bill late last week but failed to gain support from the committee's top GOP member prior to Wednesday's mark-up of the FDA Revitalization Act (S. 1082).

April 18, 2007 | Daily News

Now that Democrats in both chambers have passed budget plans with language allowing up to $50 billion to reauthorize SCHIP, the next sticking point in the debate seems destined to revolve around who exactly should be covered under the popular program, which will sunset at the end of September without legislative action.

April 18, 2007 | Daily News

Contentious Senate legislation that would have allowed the government to negotiate lower drug prices under Medicare Part D failed on a procedural vote Wednesday morning, garnering only 55 of the 60 votes needed to avert a GOP filibuster threat. Future Senate action on the issue is in doubt, with Senate Majority Leader Harry Reid (D-NV) Tuesday (April 17) blaming Republicans for protecting the pharmaceutical and insurance industries, though key lawmakers have vowed the fight is far from over.

April 18, 2007 | Daily News

The Senate health committee Wednesday (April 18) passed an FDA reform/user fee bill that no longer requires risk evaluation and mitigation strategies (REMS) for all drug applications. The committee-passed bill also gives FDA more authority to force drug label changes than did an earlier draft, requires that drug approval documents be published, requires more clinical trials be registered, changes pediatric exclusivity measures, includes medical device user fees and adds $50 million annually in drug fees to pay for REMS.

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