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Congress

May 08, 2007 | Daily News

House Democrats are preparing legislation that may work as an incentive for beneficiaries to couple traditional Medicare with a supplemental benefit such as Medigap, a supporter of Medicare Advantage (MA) payment cuts says. At a May 3 Ways & Means Committee hearing, lawmakers also pushed various proposals to eliminate the Part D late-enrollment penalty, modify the low-income subsidy (LIS) asset test and streamline applications for state-federal health programs.

May 08, 2007 | Daily News

CMS and the Social Security Administration (SSA) have created several work groups that are expected to finalize recommendations this summer on how to improve Medicare-related data transfers between the two agencies. The move comes as Congress is stepping up oversight after a series of glitches affecting Part D and low-income subsidy (LIS) enrollees.

May 08, 2007 | Daily News

Consumer advocates are unhappy with changes to consumer drug advertising restrictions negotiated in an amendment to the FDA bill the Senate is debating on the floor. The amendment scraps earlier language that would have let FDA impose 2-year moratoriums on drug ads and in exchange lets FDA require safety information as part of consumer ads -- but consumer advocates say the new requirement may be hard to implement.

May 07, 2007 | Daily News

The Senate Monday (April 7) put off until Tuesday or later in the week a final vote on a revised FDA reform bill that includes a compromise on citizen petition restrictions and scraps an earlier proposal to let FDA impose a two-year moratorium on consumer drug advertising. Before ending debate Monday senators voted to allow drug imports but with a major caveat that effectively kills the prospect of such imports: the HHS secretary would have to certify drug reimportation is safe.

May 07, 2007 | Daily News

BOSTON--Former FDA head Mark McClellan praised biogenerics legislation proposed by several House Oversight and Government Reform Committee members that is seen as largely favorable to the innovator biopharmaceutical industry. Two retired healthcare lawmakers -- former Ways & Means Chair Bill Thomas (R-CA) and former Louisiana senator John Breaux -- agreed the bill lends to a positive discussion about creating an FDA approval pathway for follow-on-biologics.

May 07, 2007 | Daily News

CMS issued guidance late last month emphasizing no hospital participating in Medicare can rely on dialing 911 to transfer patients in an emergency. The guidance follows a congressional investigation into the agency's oversight of a Texas specialty hospital that called 911 when a patient went into respiratory arrest and later died. Senate Finance Committee leaders applaud the guidance as a good first step, but specialty hospitals object to the blanket exemption.

May 04, 2007 | Daily News

A bipartisan team of Congress members, backed by a highly diverse and influential group of stakeholders, introduced a wide-ranging SCHIP reauthorization bill on Thursday that relies on public and private initiatives to expand and streamline the program. The Healthy Kids Act, authored by House Ways & Means Committee members Rahm Emanuel (D-IL) and Jim Ramstad (R-MN), and co-sponsored by several well-placed colleagues, would appropriate $60 billion over five years to the popular State Children's Health Insurance Program (SCHIP).

May 04, 2007 | Daily News

House Energy & Commerce health subcommittee Chair Frank Pallone (D-NJ) is holding talks with Rep. Bobby Rush (D-IL) on ways to tweak Rush's bill banning most payoffs brand drug companies use to thwart generic competition, a source close to Rush said Thursday (May 3). At issue is whether a brand drug company should be allowed to pay a generic drug company to keep its generic off the market, thereby also keeping other generics off the market.

May 04, 2007 | Daily News

Democratic Sen. Hillary Clinton (NY) said Friday (May 4) Congress should let FDA charge user fees to inspect food processors and storage facilities. Such fees are not included in a food safety amendment attached Wednesday to the Senate FDA reform bill, and would be opposed by a key House food safety advocate.

May 04, 2007 | Daily News

Senate Finance leaders are again debating what course to take on a controversial CMS Medicaid state payment rule now that President Bush has vetoed the war supplemental bill which would have delayed the rule by one year. The last-minute Medicaid rider was agreed to by Finance Chair Max Baucus (D-MT) but hotly opposed by top GOP committee member Charles Grassley (R-IA), who loudly complained that appropriators had poached Finance turf.

May 03, 2007 | Daily News

Former FDA commissioners told House lawmakers Tuesday (May 1) FDA should renegotiate treaties with other countries, particularly China, to ensure their food inspection standards are up to par with U.S. requirements and also improve domestic food safety oversight. Current food agreements are inadequate in light of recent reports of human and pet food contamination, two of the former commissioners said.

May 03, 2007 | Daily News

Senate Finance Committee lawmakers took a first step Wednesday (May 2) toward reforming smaller aspects of the Medicare Part D program in a hearing that highlighted widely reported pharmacy issues and data transfer problems. The committee will continue the debate next week with representatives of CMS, the Social Security Administration (SSA) and Government Accountability Office (GAO) slated to testify.

May 02, 2007 | Daily News

Senators Wednesday (May 2) voted unanimously to attach to the FDA reform bill a compromise food safety measure that would require food and pet-food processors to report suspected contamination to FDA, give agency inspectors easier access to company records during inspections, and make FDA write processing and ingredient standards for pet food. The compromise does not let FDA mandate food recalls, sidestepping an earlier push by key Democrats to give the agency such authority.

May 02, 2007 | Daily News

The Senate health committee will mark up biogenerics legislation June 13 and attach it later to the omnibus FDA reform bill during conference with the House, lawmakers said Wednesday. Although senators could not hammer out a compromise in time to amend the FDA Revitalization Act during floor debate, they put a "placeholder" in the bill so they could include it later.

May 02, 2007 | Daily News

The Senate will pick up debate on the FDA reform bill Thursday morning with a drug importation amendment, which if passed could draw a presidential veto to the entire bill (see related story).

On Wednesday lawmakers added food safety legislation to the omnibus FDA bill and promised to work a biogenerics measure for inclusion during conference (see related stories). Senators are still trying to compromise on a drug consumer advertising measure in the bill, which lawmakers say is the main hold up.

May 01, 2007 | Daily News

Health committee leaders made some significant last-minute changes to the FDA reform bill they brought to the Senate floor Monday -- including changes that further restrict FDA's authority to require risk mitigation plans for drugs, water down advertising restrictions, and waive restricted distribution plans for biodefense products. But outstanding issues remain, key sources say, and the bill is a moving target as lawmakers continue to work out compromises.

May 01, 2007 | Daily News

The White House signaled to lawmakers Monday (April 30) the president would veto the FDA reform/user feel bill if drug reimportation language is added, and would strongly oppose the addition of follow-on biologics to the FDA bill being debated on the Senate floor. The administration also urged lawmakers to scrap the bill's drug advertising restrictions and raised continued concerns with its risk management requirements.

April 30, 2007 | Daily News

A group of pediatric disease advocates is calling on Congress to restore permanent pediatric research requirements in the FDA reform/user fee bill during Senate floor debate this week. The advocates are upset the bill that passed the health committee did not include language in an earlier draft that would have eliminated the "sunset" language in a pediatric research law.

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).

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