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Rx Drugs

January 06, 2004 | Daily News

CMS has substantially lengthened the time it will require drug manufacturers to retain their Medicaid drug rebate pricing records following pressure from state and congressional officials who argued that the agency's planned three-year limit would hamper Medicaid fraud investigations.

January 05, 2004 | Daily News

A trade association representing state pharmacy boards has teamed up with a pharmacy group and the U.S. Pharmacopeia (USP) to create a program that would accredit compounding pharmacies that meet certain quality standards. Along with compounding, the National Association of Boards of Pharmacy will focus its efforts in 2004 on curbing counterfeit drugs and responding to states' efforts to reimport Canadian drugs.

January 05, 2004 | Daily News

Drug producers and patient advocates have begun lobbying CMS to cover specific cancer and multiple sclerosis drugs under a two-year demonstration program that must come under a $500 million budget cap.

The Medicare reform law mandates the program under Section 641, but does not specify which drugs or treatments will be covered, although cancer and multiple sclerosis are targeted for coverage until the full drug benefit takes effect in 2006. CMS has to implement the demonstration within 90 days of the law's Dec. 8, 2003, enactment.

January 05, 2004 | Daily News

A federal court has overturned FDA's decision that generic drug company Torpharm must share 180-day market exclusivity for its generic version of Paxil (paroxetine), and is blocking the agency from approving any competing generic version of the drug until Torpharm's 180-day exclusivity expires in March. The judge said FDA's view that Torpharm and other generic drug firms should share exclusivity because they all were the first to challenge different innovator patents violates the Food, Drug and Cosmetic Act.

December 31, 2003 | Daily News

The recent Medicare law's reform of drug reimbursement, regional physician rates, and physician updates will add $1 billion to Medicare's 2004 outlays, according to a CMS rule released today (Dec. 31).

December 30, 2003 | Daily News

In the wake of landmark passage of a Medicare prescription drug benefit, AARP is now turning its attention to holding down drug costs, earmarking reimportation and evidence-based drug selection as key mechanisms it plans to work on this year.

December 30, 2003 | Daily News

Two of the Senate's swing votes on the Medicare bill have asked the General Accounting Office (GAO) to keep tabs on pharmaceutical drug prices so as to monitor the effect of price hikes on the purchasing power of the new discount card and on the cost of the future drug benefit.

December 22, 2003 | Daily News

Medicare conferees included language in a manager's statement accompanying the Medicare reform bill stating that retiree plans can scale back benefits for Medicare-eligible beneficiaries, even though AARP successfully killed legislative language specifically allowing such differential treatment.

December 22, 2003 | Daily News

Physicians stand to reap significant federal financial help and potential bonus payments from Medicare Advantage plans if they adopt the electronic prescribing approach laid out in the new Medicare drug law.

December 19, 2003 | Daily News

On the eve of his departure, CMS Administrator Tom Scully said keeping good agency staff is critical to the successful implementation of the massive Medicare bill passed into law this month.

"I think the staff is great but I just hope we can keep the people around to get it done. I think there are a lot of good people here and if we keep the people we have and hire some more good ones I think it's do-able, but it's a hell of a lot of work," he told Inside CMS.

December 18, 2003 | Daily News

Canadians, as well as the Japanese and most Europeans, actually pay slightly more than Americans for brand-name and generic drugs when per capita incomes are taken into consideration, according to a study by the University of Pennsylvania comparing average drug prices among nine representative countries.

Such findings could make it difficult for FDA Commissioner Mark McClellan to argue that other countries should back off drug price controls and pay more of their fair share -- a position McClellan has adopted lately in his public speeches.

December 18, 2003 | Daily News

Two of the House authors of the newly enacted Medicare prescription drug benefit are seeking to refute criticism that the legislation does not allow insurers to cover gaps in coverage, but a manager's statement accompanying the legislation acknowledges the financing structure provides a disincentive for drug plans to close the coverage gap.

December 18, 2003 | Daily News

Boston Mayor Thomas Menino (D) is threatening to go ahead with a program to reimport drugs from Canada for city employees if FDA does not come up with a plan to allow for reimportation within six months. On Thursday (Dec. 18) Menino urged FDA officials to set up an advisory board to advise the HHS secretary on reimportation issues. Menino plans to follow up with the agency within 60 days.

Menino says the advisory board could help the HHS secretary with the study on reimportation required under the Medicare law.

December 18, 2003 | Daily News

The Congressional Budget Office (CBO) has downgraded its projections of the ability of future Medicare prescription drug plans to contain drug costs because of provisions in the newly enacted law outlining beneficiary rights to appeal formularies, requiring drug plan and manufacturer disclosure of drug price concessions and reducing the risk borne by drug plans.

December 17, 2003 | Daily News

A drug industry representative contends that FDA will lose its credibility and authority if the agency does not stop states and cities from reimporting prescription drugs from Canada. The representative slammed states for insisting on reimportation as a solution for high drug prices and said their plans are not a long-term solution.

Reimportation is a gimmick and its supporters are engaging in political gamesmanship, the representative charged.

December 17, 2003 | Daily News

Vermont, one of the latest entrants into the prescription drug reimportation debate, is seeking FDA's approval to reimport cheaper prescription drugs from Canada for the state's employees. Under the state's proposed program, Canadian doctors would rewrite drug prescriptions as Canadian prescriptions after reviewing the patient's medical history. Licensed Canadian pharmacies could then fill these prescriptions and mail the drugs back to the patient in the United States.

December 16, 2003 | Daily News

Still struggling with a negative fiscal outlook, states are worried Medicare's new drug benefit could diminish their pharmaceutical purchasing power under Medicaid -- one of the states' major tools in their battle to lower prescription drug prices.

December 15, 2003 | Daily News

Technical corrections to the mammoth Medicare bill President Bush recently signed into law are unlikely to take place next year, according to GOP congressional aides.

Many industry sources and observers are widely speculating that a technical amendment package will be pursued next year, but GOP aides are downplaying the possibility. "We think there's got to be a year cooling off period at least," one Republican source aide, adding that it is premature to talk of a technical corrections bill so soon after the legislation was passed.

December 15, 2003 | Daily News

The decision by Medicare conferees not to subsidize certain state pharmaceutical assistance programs for delivering the Medicare drug benefit means state governments will likely have to push seniors to sign up for a confusing new Medicare drug plan even if they are enrolled in state programs that provide superior benefits.

The recently passed bill will allow state programs to "wrap-around" the gaps in the Medicare drug benefit, amounting to significant savings for the costly state programs -- assuming that seniors will switch over to it.

December 12, 2003 | Daily News

Key Democrats in the House and Senate who have opposed reimportation in the past are now pushing a more restrictive alternative that would allow reimportation from Canadian exporters inspected and certified by FDA. The move splits Sen. Edward Kennedy (D-MA) and Rep. John Dingell (D-MI) from Senate Minority Leader Tom Daschel (D-SD) and other Democrats who are pushing for broader reimportation.

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