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Rx Drugs

June 24, 2003 | Daily News

With the House slated to vote on Medicare reform legislation this week, Democrats in that chamber today (June 24) stepped up their opposition to the Republican-drafted plan by issuing fresh criticism that the bill would be particularly harmful for rural beneficiaries.

At a press briefing, Democrats reiterated claims that the GOP plan has "huge" coverage gaps, does not curb high drug prices, privatizes Medicare and fails to provide a guaranteed, defined set of costs and benefits -- problems which are magnified in rural areas, said House Minority Leader Nancy Pelosi (D-CA).

June 23, 2003 | Daily News

Both Senate and House Medicare reform bills would prevent CMS from applying a controversial "functional equivalency" policy to reduce Medicare reimbursement rates for drugs in the pass-through system. The move is good news for biotechnology companies, which lobbied hard for the policy shift.

The legislative move follows an unsuccessful effort by several lawmakers from both chambers of Congress to get CMS to withdraw the standard.

June 23, 2003 | Daily News

The House Ways and Means and Energy and Commerce committee leaders are negotiating over language in their Medicare bills on functional equivalence, with Energy and Commerce Committee Chairman Billy Tauzin (R-LA) seeking to permanently bar CMS from setting lower reimbursement rates for new drugs with the same therapeutic effect, a House GOP aide said today (June 23).

The Energy and Commerce Committee amended the Medicare legislation at its June 19 markup to bar CMS from applying a new functional equivalence standard to any drugs not already subject to the standard.

June 23, 2003 | Daily News

The House authors of Medicare legislation are looking to follow the Senate lead by tacking on legislation easing importation of pharmaceuticals from Canada and scaled-back legislation speeding the market entry of generic drugs, a House GOP aide said.

June 20, 2003 | Daily News

The Senate today (June 20) amended Medicare legislation to ease re-importation of cheaper pharmaceuticals from Canada, but made implementation subject to a decision by the HHS secretary, likely preventing the amendment from taking effect.

A second degree amendment offered by Majority Leader Bill Frist (R-TN) prevents the re-importation amendment from taking effect until the HHS secretary certifies that it poses no new risk to public health and safety and will significantly reduce drug prices.

June 20, 2003 | Daily News

Contrasting language on average wholesale price (AWP) reform is among the key items to be reconciled by the House Rules Committee when it takes up Medicare reform legislation next week.

The rules committee is expected to take up the Medicare bills June 25, with floor consideration tipped for the following day. Both the House Energy and Commerce and Ways and Means committees passed Medicare reform legislation this week, reporting out largely similar bills, but with some key differences.

June 19, 2003 | Daily News

Medicare reform legislation pending in the House would give a subsidy for retiree plans that provide adequate drug coverage, slightly reducing the number of retirees projected to lose coverage with the introduction of a new Medicare prescription drug benefit. A different employer subsidy plan is included in the Senate bill.

June 19, 2003 | Daily News

Physicians would have a choice of two reimbursement methodologies for outpatient drugs in a revised fix to the Average Wholesale Price (AWP) system included in the House Medicare bills being marked up this week.

Physicians can opt out of a new procurement system that uses competitive bidding from drug suppliers and instead be reimbursed according to the average manufacturers' sales price, a methodology that, unlike AWP, accounts for the rebates and discounts physicians receive when they purchase drugs.

June 19, 2003 | Daily News

House GOP lawmakers made last-minute changes to their Medicare bill to phase in the start of head-to-head competition between traditional Medicare and private plans, as the Bush Administration is taking a hands off approach to the measure it views as potentially disruptive to the bipartisan consensus needed to pass a prescription drug benefit. The Senate bill does not include the controversial competition provision.

June 19, 2003 | Daily News

The Senate today (June 19) voted 94-1 to attach legislation designed to speed generic drugs to market to a Medicare prescription drug bill. But in a separate vote, the Senate gave Democrats their second defeat in two days in their efforts to change the shape of the Medicare drug benefit.

The Senate also incorporated new protections for pharmacists already found in the House Medicare legislation.

The generic drug amendment, offered by Sen. Judd Gregg (R-NH) is based on S. 1225. The lone vote against the bill came from Sen. Orrin Hatch (R-UT).

June 18, 2003 | Daily News

The rump group of five GOP Energy and Commerce lawmakers is preparing to offer its Medicare reform proposal on the House floor next week even though elements of the plan were added to the GOP bill during committee markup yesterday (June 18), according to a source close to the group and statements made by one of its members.

June 18, 2003 | Daily News

Senate Democrats are planning to once again float a proposal to sunset the Medicare drug benefit in a bid to come up with funding to eliminate the gap in prescription drug coverage under the Senate Medicare reform bill. The proposal is one of several amendments Democrats say they intend to offer during the ongoing Senate Medicare floor debate in an attempt to improve the compromise legislation.

June 17, 2003 | Daily News

The "rump group" of five Energy and Commerce Committee Republicans has reached a deal with committee chair Billy Tauzin (R-LA) and will support committee passage of a revised version of the GOP Medicare drug benefit bill, members of the group said. Under the deal, Tauzin will include the group's prescription drug plan -- which includes low-income protections, a drug discount and debit card approach to paying for prescription drugs -- as a transitional element and then a fallback option in the GOP bill, Rep. Steve Buyer (R-IN) told Inside CMS.

June 17, 2003 | Daily News

A key Senator in the generic drug access debate says Congress should change provisions of the Senate's compromise bill that would continue the current practice of lumping patent invalidity and patent non-infringement challenges. Sen. Orrin Hatch (R-UT), an author of the 1984 drug patent law and chair of the Senate Judiciary Committee, also is upset that the compromise drug patent reform bill would retain a provision that grants the first company to file a generic drug application 180 days of market exclusivity.

June 16, 2003 | Daily News

Drug and medical device companies may have a better chance of getting product liability protections now that the House is considering attaching its medical malpractice bill to Medicare legislation, and the Congressional Budget Office (CBO) is saying the Republican's medical malpractice proposal would save the Medicare program $15 billion over 10 years, according to a congressional source.

June 13, 2003 | Daily News

Medicare reform legislation appears set for Senate passage following broad approval by the Senate Finance Committee last night, with six Democrats, including the caucus' top member, voting for the package.

The Finance Committee reported out the Prescription Drug and Medicare Improvement Act of 2003 virtually unaltered from the amended version presented earlier June 12 by Chairman Chuck Grassley (R-IA). The bill passed 16-5.

June 13, 2003 | Daily News

When it marked up drug patent reform legislation this week, the Senate health committee failed to take up an unexpected FDA recommendation that lawmakers change current law to state that a court decision would no longer start the 180-day generic drug exclusivity clock. The proposal is one of many "technical corrections" that FDA has suggested senators include in the drug patent reform bill.

June 13, 2003 | Daily News

House Ways and Means Committee Chairman Bill Thomas (R-CA) and the largest Medicare beneficiary advocacy group disagree on whether the catastrophic benefit of the House GOP Medicare reform bill constitutes "means testing."

June 13, 2003 | Daily News

Senate Democrats are planning to attach drug reimportation legislation to the Senate Medicare bill, according to Debbie Stabenow (D-MI), who tried the same thing last year. The reimportation legislation will mirror last year's bill.

In the House, Rep. Gil Gutknecht (R-MN) this week also introduced a bill to allow individuals, pharmacists and wholesalers in America buy FDA-approved drugs from FDA-approved facilities in industrialized nations. Gutknecht emphasized the importance of controlling the price of pharmaceuticals before taking up Medicare prescription drug benefit.

June 12, 2003 | Daily News

A tightly held Ways and Means Committee summary of the main GOP Medicare reform bill shows that House Republican leaders plan to craft a front-loaded prescription drug benefit to ensure that most seniors will benefit from the plan. The bill also attempts to address concerns pharmacies raised to last year's bill, includes Medicare modernizations, and would revamp the drug reimbursement system.

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