Firms Should Be Proactive in Planning for New Medicare Pricing Disclosure Rule

Pharmaceutical firms have yet to fully understand the implications of the Medicare Rx drug benefit, say experts who urge drugmakers to develop compliance strategies around the new regulations requiring the disclosure of drug pricing.

Under the Medicare Modernization Act (MMA), prescription drug plan (PDP) sponsors -- which will implement the Rx benefit starting in 2006 -- must provide both beneficiaries and the Centers for Medicare & Medicaid Services with access to the negotiated prices they obtained from manufacturers.

The pricing disclosure regulation, from the government's perspective, will encourage the prudent purchasing of drugs, and ensure the lowest available prices are passed along to Medicare beneficiaries, said Keith Korenchuk, a partner with the law firm McGuireWoods.

Both PDP sponsors and drug manufacturers must deal with this "very important concept" in the MMA's final regulations, he told a recent FDAnews audioconference. There is going to be close scrutiny of pricing levels and concessions, and how they get passed through to beneficiaries and the Medicare program, Korenchuk said.

For an audio CD recording and written transcript of the audioconference, "Medicare Part D for Drugmakers: New Requirements, New Risks, New Markets," contact FDAnews at (888) 838-5578 or http://www.fdanews.com/wbi/tapelibrary/545-1.html (http://www.fdanews.com/wbi/tapelibrary/545-1.html).