HEALTH

Pharmacy groups praise delay of DME accreditation deadline

BY Michael Johnsen

ALEXANDRIA, Va. Both the National Community Pharmacists Association and the National Association of Chain Drug Stores recently praised Senate and House action to extend durable medical equipment accreditation Medicare deadlines for pharmacies.

H.R. 3663 was introduced by Reps. Zach Space, D-Ohio, and Lee Terry, R-Neb., and passed the House by voice vote last week. The Senate then passed the House bill by unanimous consent on Monday.

The Medicare accreditation deadline was extended through the end of the year from a prior deadline of Sept. 30.

“In the debate over healthcare reform legislation, NACDS continues to advocate for an exemption for pharmacy from this accreditation requirement, as well as from the surety bond requirement – exemptions that have been afforded to other healthcare providers,” stated NACDS president and CEO Steven Anderson.

Stated Bruce Roberts, NCPA EVP and CEO, “The Senate acted wisely to ensure seniors can continue purchasing essential medical supplies from their community pharmacies. Without it, thousands of independent community pharmacies would be forced to stop supplying diabetes testing supplies and other products to their patients.”

If signed into law by President Obama, H.R. 3663 would delay the Centers for Medicare and Medicaid Services deadline for pharmacies to obtain accreditation in order to furnish DME products, like diabetes testing supplies, to Medicare beneficiaries. Both the House and Senate have included provisions to exempt pharmacies from the accreditation requirement in their versions of health reform legislation.

According to NCPA, the DME accreditation requirements have proved to be onerous, expensive and duplicative for community pharmacists, who already must meet state licensing requirements. Pharmacists have not been associated with the fraud targeted by the regulations, NCPA argued, but are the only health care providers not yet exempted. For these reasons, securing an exemption for community pharmacies has been a top legislative priority for NCPA.

In addition to the legislation, 54 members of Congress also wrote a letter to acting CMS administrator Charlene Frizzera, requesting an immediate delay of the DME accreditation and $50,000 surety bond requirements for community pharmacies. The letter was led by Reps. Space, Marion Berry, D-Ark., Jo Ann Emerson R-Mo., and Jerry Moran, R-Kan..

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NPA testifies against illegal steroids

BY DSN STAFF

NEW YORK Here’s the breakdown: Two government officials representing the Food and Drug Administration and the Drug Enforcement Agency joined Travis Tygart of the U.S. Anti-Doping Agency (the body responsible for keeping performance-enhancing drugs out of U.S. Olympic athletes), Daniel Fabricant of the Natural Products Association and Richard Kingham, a litigator specialized in food/drug law, before a panel of senators — less to inform the Senate around the problem of steroids sold as dietary supplements, and more to be grilled by those senators as to why those products are actually on any market.

 

The senators were Sens. Orrin Hatch, R-Utah, and Arlen Specter, D-Pa., who played a sort of good cop/bad cop routine. Hatch was the good cop, at least as the dietary supplement industry goes, as he defended the legislation governing the regulation of dietary supplements that he helped draft some 15 years ago. Specter played the bad cop — questioning the regulatory priorities of the two governing bodies present, while raising the thought of adding more regulations to the FDA and/or DEA already-underutilized toolbox.

 

Following the hearing, dietary supplements emerged as the unwilling participants in all of this talk around performance enhancing supplements. You almost had to wonder why Fabricant was present, except to politely remind everyone that the dietary supplement manufacturers who actually distribute product through mass-channel retailers actually fought for (as in not against) such additional regulations as certified good manufacturing practices or mandated serious adverse event reports, and as such are not likely to field illegal products.

At stake in all of this is whether or not legitimate dietary supplement players ought to seek premarket approval, a condition that if ever really implemented, would decimate any future innovation in the almost $6 billion mass-channel business (according to the latest Nielsen Company figures). It’s also a condition that wouldn’t actually do much to pull those steroid drugs masquerading as supplements off the market, unless you expect those well-respected criminals to actually file an NSA (new supplement application) that contained ingredients that would not only land their consumers in the hospital, but would also land them in jail if ever actually discovered in the trunks of their cars.

The alternative, proposed by Hatch, is to place more resources behind enforcement of the laws on the book, as opposed to creating new laws that would more likely cripple legitimate manufacturers as actually inhibit outliers from selling steroids.

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GNC seeks competitive edge with new store format

BY DSN STAFF

NEW YORK GNC is taking its boutique-style specialty shop to a whole new level, especially as it starts folding in product lines not normally part of a specialty supplement shop’s repertoire — yoga, pet supplements, probiotics, homeopathic health remedies, natural skin care, natural oral care and a wider assortment of arguably commodity-type supplement offerings, such as multivitamins and such popular health supplements as vitamin D or fish oil.

 

You’ve got to wonder, though, how much GNC’s relationship with Rite Aid is playing a part in all of this. GNC now has some 10 years under its belt in its partnership with Rite Aid, which means some 10 years of gleaning insights on how Rite Aid has successfully positioned that GNC store-within-a-store concept as a more profitable supplement center and a true point-of-differentiation.

 

It’s also been about two years since one of the Rite Aid executives who helped develop and nurture that GNC/Rite Aid concept in the beginning has been at the helm at GNC aspresident and chief merchandising and marketing officer. “GNC has a very unique position in the market,” Beth Kaplan told Drug Store News soon after she joined GNC. “GNC’s initial DNA is built around vitamins and supplements,” she said then, not just diet aids and sports nutrition.

It’s certainly a smart play — it’s more reflective of today’s healthcare mood as politicians continue to debate how to best infuse a cost-saving well-care sentiment in healthcare reform over the sick-care model that exists today. And it de-emphasizes perhaps the two more controversial categories GNC is currently best-known for — weight loss diet aids and sport nutrition supplements. They’re not abandoning those segments of course — it’s still going to occupy half the store’s footprint after all — and nor should they. They’re legitimate businesses when marketed and merchandised responsibly. But the fact remains that both weight loss and  sports nutritionals are under greater scrutiny with today’s more-aggressive Food and Drug Administration and the controversy surrounding performance-enhancing drugs being illegally marketed as supplements — the subject, in fact, of a Congressional hearing held just last week.

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