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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Report: Oklahoma may reverse-switch PSE law

BY Michael Johnsen

OKLAHOMA CITY According to an Associated Press report published Thursday, Oklahoma may join California in considering the reverse-switch of pseudoephedrine, making the common decongestant available only with a doctor’s prescription, in an effort to stem methamphetamine production.

Oklahoma arrests for methamphetamine production have risen sharply over the past 18 months, peaking in April when 37 cases involving a total of 74 defendants were filed in state district court, according to the report.

Rep. Lucky Lamons, D-Tulsa, Okla., announced plans to introduce the reverse-switch legislation in  2010.

Both the Oklahoma Pharmacists Association and the Consumer Healthcare Products Association oppose the proposed measure, arguing that the are policies in place, if enforced, would effectively stem meth production while still maintaining legitimate access to the cold medicine.

Similar to California and in Missouri, CHPA has offered to fund a state-wide electronic logging system that would enable law enforcement to track people attempting to purchase more than their legal limit in PSE products in real time.

Oregon is currently the only state that requires a prescription for pseudoephedrine products.

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