PHARMACY

Pharmacy exemption from DME requirements gains momentum as groups pressure Congress to act

BY Michael Johnsen

ALEXANDRIA, Va. An influential small business advocacy group and several respected healthcare associations have joined the National Community Pharmacists Association in urging Congress to exempt community pharmacies from the Oct. 1 accreditation and surety bond requirements needed to continue providing durable medical equipment, prosthetics, orthotics and supplies to Medicare patients, the NCPA announced Tuesday.

The National Federation of Independent Business, National Rural Health Association, American Association of Diabetes Educators and the Diabetes Access to Care Coalition have each sent letters to the Senate and House committees of jurisdiction supporting accreditation exemption bills, specifically, S. 511, introduced by Sens. Jon Tester, D-Mont., and Sam Brownback, R-Kan., and H.R. 616, introduced by Reps. Marion Berry, D-Ark., and Jerry Moran, R-Kan. The surety bond exemption bills are S. 956, introduced by Sens. Tester and Pat Roberts, R-Kan., and H.R. 1970, introduced by Reps. Zach Space, D-Ohio, and Jo Ann Emerson, R-Mo.

In other positive developments, House Democratic leaders included similar provisions in their health care reform bill H.R. 3200, America’s Affordable Health Care Choice of 2009. And key U.S. lawmakers have written to the Centers for Medicare and Medicaid Services asking that pharmacies be exempted.

“The DME accreditation and surety bond requirement deadlines are fast approaching, and for patients who depend on supplies such as diabetes test strips this is problematic,” stated Bruce Roberts, NCPA EVP and CEO. “The reason is many community pharmacies might stop selling these supplies, which compliment the medications patients get from their stores. In underserved communities the ensuing access problems could be even more acute. We appreciate the House’s inclusion of exemption language in H.R. 3200, and hope the Senate Finance Committee will act similarly when they unveil their health care reform bill.”

“There is strength in numbers, and the various organizations supporting DME exemptions clearly indicate the policy must change,” commented Holly Whitcomb Henry, NCPA president and a Seattle pharmacy owner. “From the National Federation of Independent Business to the National Rural Health Association the message is clear: Congress must act to ensure patients can access medical supplies at their local pharmacies.”

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PHARMACY

Taro files patent infringement suit against three companies

BY Alaric DeArment

HAWTHORNE, N.Y. An Israeli generic drug maker has sued three other companies, alleging patent infringement.

Taro Pharmaceutical Industries announced Monday that it had filed suit in the U.S. District Court for the District of New Jersey against Synerx Pharma, DPT Labs and Karalex Pharma, alleging infringement of U.S. Patent No. 7,560,445. The patent covers Taro’s Ovide (malathion) lotion in the 0.5% strength, a treatment for head lice.

Taro said the defendants’ generic versions of the drug infringed its patent, and it’s seeking injunctive relief and damages.

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News article calls Mylan’s quality control into question; company responds

BY Alaric DeArment

PITTSBURGH A news article published over the weekend calling generic drug maker Mylan’s manufacturing into question has drawn a response from the company.

The Pittsburgh Post-Gazette reported Sunday that workers at the company’s Morgantown, W.Va., plant overrode drug quality controls required by the government by ignoring and deleting computer warnings of possible drug quality or equipment problems, based on a confidential internal report obtained by the newspaper’s reporters that called it a “pervasive” problem. Normally the warnings, known as “red screens,” require production to halt until a quality-control agent can investigate the matter.

The company responded by saying in a statement Monday that the Post-Gazette article was based on anonymous sources, improperly obtained documents and third-party commentary.

“Our customers and stakeholders can rest assured that whenever there is even the slightest departure from [a standard operating procedure], it will be dealt with immediately and effectively,” the company said in a statement. “This issue had no impact on the quality of our product.”

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