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Congress

May 23, 2007 | Daily News

An agreement worked out between congressional Democrats and the White House on the war supplemental spending bill retains earlier language pushed by Majority Whip Sen. Richard Durbin (D-IL) slapping a moratorium on two CMS Medicaid rules, congressional insiders indicated Wednesday (May 23).

May 23, 2007 | Daily News

The House is gearing up to cut Medicare payments to Medicare Advantage plans, specifically targeting private fee-for-service plans, according to a key House lawmaker who is armed with ready-made endorsements from organized medicine and hospital groups who support the move. Rep. Pete Stark (D-CA), the Ways & Means health subcommittee chair, said Tuesday (May 21) these MA plans are at the "top of the list" of stakeholders who are slated for Medicare payment reductions, set to be handed down sometime next month.

May 23, 2007 | Daily News

FDA would not have identified heart problems associated with Avandia earlier had the drug safety measures in the Senate FDA Revitalization Act been in place, according to a New England Journal of Medicine (NEJM) editorial published this week -- an assertion one of the bill's authors refutes.

May 22, 2007 | Daily News

An aide to Finance Committee Chair Max Baucus (D-MT) said Tuesday (May 22) the lawmaker is working to keep in the Senate's evolving rewrite of the war supplemental bill a provision allocating $650 million in funding to cover a projected shortfall in the State Children's Health Insurance Program (SCHIP). Capitulating to White House objections, Democrats had dropped a number of domestic provisions from the supplemental, and earlier reports indicated SCHIP might be among them.

May 21, 2007 | Daily News

The Infectious Diseases Society of America is lobbying the House to strengthen a measure on antibiotic resistance included in the FDA bill passed by the Senate, an IDSA source says. IDSA wants a section on "single enantiomers" to apply to antimicrobials so such products can get five years of market exclusivity, and wants to reauthorize a defunct antimicrobial task force.

May 21, 2007 | Daily News

Gearing up for a Tuesday showdown with congressional critics of Medicare Advantage (MA) plans, CMS officials defended the controversial program Monday (May 21), citing the additional benefits offered to vulnerable populations and the coordination of care available for patients with multiple chronic illnesses.

Critics of the program contend the highly subsidized program does more to benefit insurers than patients, and a number of key Democrats are eyeing an end to the federal subsidies as a method to pay for other Medicare-related legislation this year.

May 21, 2007 | Daily News

As Congress weighs changes at FDA, the agency is in hot water again for taking its time to warn the public about the safety of a drug -- this time for not more quickly warning that Avandia may cause heart attacks in diabetes patients. Congressional investigators were after FDA to do more to alert patients about the popular diabetes drug well before the New England Journal of Medicine Monday (May 21) published a study on Avandia's risks.

May 18, 2007 | Daily News

Some industry lobbyists are worried a provision in the Senate FDA bill that uses sales figures to cut the market protection incentive afforded drug makers that do pediatric research could set a precedent for other types of "exclusivities."

The lobbyists hope the House will revisit the provision when it drafts its version of the bill passed by the Senate last week. S. 1082 includes provisions authorizing the collection of user fees and pediatric research laws, as well as other provisions on drug safety, food safety, clinical trial registries and drug patent reforms.

May 17, 2007 | Daily News

Senate drug safety maverick Charles Grassley (R-IA) is pointing to FDA's alleged slowness in getting safety data on widely prescribed anti-anemia drugs in his latest bid to get FDA the power to demand drug companies hand over certain study data. Grassley says time is of the essence, as the Senate has already passed its FDA reform bill but the House has yet to act on what may be Congress' only attempt at reforming the agency for years.

May 17, 2007 | Daily News

Key House lawmakers this week offered support to community pharmacists who descended onto Capitol Hill to push several Medicaid and Medicare proposals. But it remains unclear whether Democratic leaders will use a catch-all health reform bill later this year to define how CMS should calculate drug-specific average manufacturer prices (AMPs) or simply delay the implementation of a related CMS regulation that is expected to slash Medicaid reimbursements to pharmacists.

May 17, 2007 | Daily News

The Democrats' $2.9 trillion spending blueprint for fiscal 2008 passed both the House and Senate Thursday (May 17), authorizing up to $50 billion for SCHIP reauthorization as well as proposing a number of additional Medicare reforms that include a boost in physician payments and a kickstart to comparative effectiveness research. But the resolution is simply an outline, leaving the difficult decisions to committee leaders who will have to find offsets for any new spending they propose.

May 17, 2007 | Daily News

House Energy and Commerce health subcommittee lawmakers hinted Wednesday (May 16) they may try to add post-market safety, device reuse and pediatric research provisions when they mark up device user fee reauthorization legislation. Democrats grilled FDA on why its user fee proposal does not set aside money for post-market safety and demanded the agency immediately hand over long over-due reports on how user fees have been used in the past for post-market surveillance and third-party inspection activities.

May 15, 2007 | Daily News

Armed with new information showing Medicare Part D drug prices increased 6.8 percent over a six month period, House oversight committee Chair Henry Waxman (D-CA) is planning new hearings on the program with the hope of spurring the Senate to revitalize the Part D negotiation bill. An aide to Finance Chair Max Baucus (D-MT) said that while Part D negotiation may not be on the front-burner right now, there's still some heat on this issue.

May 14, 2007 | Daily News

The conceptual agreement for free trade agreements worked out between House Ways & Means Committee Chair Charles Rangel (D-NY) and the Bush administration would alter three key intellectual property protection provisions in pending FTAs in ways that would make it easier for generic drugs to win marketing approval.

Critics of current FTAs have charged that they favor the rights of U.S. brand-name drug makers in overseas markets at the expense of generic drug companies.

May 11, 2007 | Daily News

As the Finance Committee gets closer to a planned June markup of legislation reauthorizing the State Children's Health Insurance Program (SCHIP), a new Congressional Budget Office (CBO) report on the popular program is bringing out some philosophical differences between committee chair Max Baucus (D-MT) and top GOP member Charles Grassley (IA) over the program's relationship to private insurance.

May 10, 2007 | Daily News

The Senate Wednesday passed legislation to block brand drug makers from using "citizen petitions" to delay generic competition. The legislation, long sought by generic drug makers, was tucked into the Senate's broader FDA reform package through an amendment by Sens. Sherrod Brown (D-OH) and Debbie Stabenow (D-MI).

The amendment would require FDA to continue reviewing generic applications while a citizen petition is considered. It also would require final action on petitions within six months.

May 10, 2007 | Daily News

A bipartisan group of House lawmakers is launching a congressional task force on intravenous immune globulin (IVIG) in an effort to refocus Congress' attention on access problems outlined in a recent HHS Office of Inspector General (OIG) report. A newly formed advocacy group, meanwhile, will enter the debate at an HHS advisory panel meeting Thursday (May 10).

May 10, 2007 | Daily News

Congress will likely dial back 2008 payments to all Medicare providers, except for physicians, in order to achieve $100 billion in savings to reauthorize SCHIP and bail out physician payments, set to plummet by 10 percent next year, a key lawmaker and health care lobbyists say. House Ways & Means health subcommittee chair Pete Stark (D-CA) told Inside CMS Thursday (May 10) "there is no area that can have a full update … every area has to be reviewed," and said he hoped providers would help divvy up the cuts.

May 09, 2007 | Daily News

Sens. Norm Coleman (R-MN) and Carl Levin (D-MI) are pushing legislation that would require CMS to screen all Medicare provider payments through the Treasury Department in a bid to identify tax cheats and collect on outstanding debts by garnishing improper reimbursements. The bill arrives as Democratic leaders have stepped up efforts to close the tax gap in order to fund a number of 2008 budget priorities -- including a Medicare physician payment fix and SCHIP reauthorization -- still in search of offsets.

May 09, 2007 | Daily News

The idea of studying which devices, drugs, biologics, medical and surgical services work best is gaining momentum as a Democratic congressman Monday introduced legislation that would create a private/public funding mechanism to fund new government research and a powerful insurance group outlined a significantly different proposal that also would add cost to the equation. The moves come as Congress' Medicare Payment Advisory Commission is pushing for an independent group to tackle comparative effectiveness, and a key Democratic senator is getting ready to unveil her own proposal.

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