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Congress

April 30, 2007 | Daily News

Democratic lawmakers introduced companion OSHA reform legislation in the House and Senate late last week that would extend OSHA protections to all workers, including federal, state and local public employees as well as flight attendants and state correctional officers; hike penalties and allow for felony charges to be brought for willful OSHA violations resulting in a worker's death; update whistleblower protections; require the Labor Department to investigate all deaths or serious injuries; and require employers pay for personal protective equipment.

April 30, 2007 | Daily News

The Senate has so far failed to limit debate on FDA reform/user fee legislation, opening the door to a flood of amendments that could drag out the debate for a week, industry sources say. Senators are still trying to reach a "unanimous consent" agreement, a former Senate staffer says, which could be used to limit the number of amendments each side gets to offer. The full Senate began debating the bill Monday (April 30).

April 27, 2007 | Daily News

As the clock winds down for the dozen or more states facing SCHIP funding shortfalls -- and money to close the gap riding on the unlikely approval of the Iraq and Afghanistan war supplemental -- a trio of influential senators have set their sights forward on a bold plan to reauthorize and expand the program by doubling the amount of covered children in 10 years. To do this, the senators say they will tap expanded cigarette taxes and overpayments to Medicare Advantage plans.

April 27, 2007 | Daily News

The Senate Republican sponsor of drug safety legislation is working with Senate health committee GOP members on a new version of the bill's key provision -- its post-market risk management measure -- and the compromise may be included in the bill or as a GOP amendment on the floor, a source says.

April 27, 2007 | Daily News

The full Senate is expected to vote on a FDA reform/user fee bill next week that closely resembles the version passed by the health committee, including the likely absence of a biogenerics measure, sources following the debate say. During last week's health committee mark up of S. 1082, many amendments were withdrawn with promises of compromise before floor debate, but committee leaders are reluctant to change much given that the committee comfortably passed the bill 15 to 6.

April 27, 2007 | Daily News

Senate health committee chair Edward Kennedy (D-MA) is circulating a new draft of his biogenerics legislation that is more favorable to generic drug makers and insurance companies than earlier discussion drafts by lowering the standard for substituting follow-on biologics for brand biopharmaceuticals.

Kennedy previously had circulated at least two drafts. One outlined specific market exclusivity, the other, which came later, left the exclusivity period blank.

April 26, 2007 | Daily News

Sens. Russ Feingold (D-WI) and Lindsey Graham (R-SC) launched an effort this week to cover the nation's uninsured by using a few states as laboratories from which to conduct a broad spectrum of experimental reforms, including the adoption of state-based health savings accounts -- popular among conservatives -- and expansions of SCHIP and Medicaid programs, favored by liberals. The senators say the bill will de-politicize a highly charged partisan issue by letting evidence, not rhetoric, lead the debate.

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.

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