Because Congress has not yet passed a permanent exemption for pharmacies from DME accreditation requirements, the Centers for Medicare & Medicaid Services says it will start sending revocation notices after Feb. 12 to pharmacies that are not yet fully accredited or in the accreditation process. For pharmacies that are in the accreditation process, they have until March 1 to get their accreditation done and submitted to CMS.

Pharmacies that have sent in a surety bond, but will not have their accreditation finished by March 1 or have elected not to be accredited, must make sure they have "stepped down" from selling DME supplies (using an 855S application) or voluntarily terminate from the program by Feb. 12.

If you sent in an 855S in late September or early October to "step down," you may have to send in a "step down" application again to the National Supply Center. CMS may not have processed that application because of the 3-month accreditation extension that was granted. If a pharmacy "steps down," it will take less time to get back into the program than if CMS revokes a pharmacy's billing number. If an unaccredited pharmacy's DME billing number is revoked, however, the pharmacy will not be able to get back into the program for another year according to CMS. NCPA continues to work with Congressional leadership to pass an extension or permanent exemption, and hopes that will happen in the very near future.

But it does not appear likely it will happen before all the requirements listed above go into effect.

By Bruce Roberts, RPh, Executive VP and CEO
National Community Pharmacists Association

We're been getting widespread anecdotal reports for weeks now that independents can't get generic Valtrex (valacyclovir) through wholesalers, but the mega-chains are buying it directly from Ranbaxy, the manufacturer. (If you have evidence of this, please send it to me).

We were growing so concerned that we wrote to Ranbaxy officials this past Dec. 17 to protest any effort to put large chains first and freeze out independents. Several wholesalers of varying size told NCPA they don't have access to valacyclovir at all. So it's possible that Ranbaxy has, in fact, struck direct-to-pharmacy deals with some large chains. Many of you may remember that the company employed the same strategy for selling its generic version of Augmentin some years ago.

Ranbaxy certainly is no stranger to more recent controversy. In late December, the FDA chided the company over its manufacturing practices and, in 2008, the agency blocked Ranbaxy from importing 30 different generics.

For more than six weeks, all we got from Ranbaxy about our letter was silence. Last week we tried again, and this week our friends at the Pharmacists Society of the State of New York, Inc. (PSSNY) also contacted Ranbaxy, India's largest pharmaceutical manufacturer in which Japanese drug maker Daiichi Sankyo owns a controlling stake.

A couple of days ago, Ranbaxy finally, belatedly responded to our letters. The company cited a shortage of raw materials, including the active pharmaceutical ingredient, as the primary factor behind its inability to meet customer demands during the 180-day exclusivity period it was awarded by the FDA for being the first generic drug application approved. (I think it's noteworthy that the FDA does not have valacyclovir on its official list of drugs in short supply. The list will cite a lack of raw materials if that is a reason for a shortage.)

Ranbaxy's response pointedly did not address whether the company struck a direct-to-large-chain distribution deal. Its answers also indicated a lack of awareness that, for some U.S. patients, an independent community pharmacy is the only health care provider for many miles around.

We are exploring several legal, regulatory, and legislative routes to address this unfair situation that really hits patients and payers and pharmacies. That's who we're going to bat for.

Another point is that the PBMs know full well what's going on. They should allow independents to bill for the brand if a generic is not available to them. 

North Texas

972.523.2064