President gives pharmacies a delay as Medicare DME requirements loom
NEW YORK It’s like “Whack-a-Mole,” that game-arcade exercise in quick reflexes and frustration.
We’re talking, of course, about the endless policy and regulatory challenges that pop out of the federal agencies and the sausage-making of congressional legislation. What with the hurdles thrown up in front of retail pharmacy by Medicare and Medicaid reimbursement, shifting health-reform proposals, managed care, HIPAA privacy and documentation rules, controlled-substance reporting requirements, etc., a new “mole” seems to emerge almost weekly.
The latest, of course, is the pending roadblocks thrown up by the Centers for Medicare & Medicaid Services to regulate the sale of DMEPOS, otherwise known in government parlance as durable medical equipment, prosthetics, orthotics and supplies.
The new rules are a legacy of the Bush administration, but they haven’t gone away. For roughly three years, chain and independent pharmacies have fought to head off new and more stringent rules from CMS governing the sale of DMEPOS to seniors enrolled in the Medicare Part B program. As originally proposed by CMS in 2006, those rules would require retail pharmacists – unlike other health professionals – to gain certification for the right to sell and distribute supplies under Medicare Part B, including even diabetes testing strips and other products. The new rules also called for the establishment of a very expensive surety bond requirement for anyone engaged in the sale of the products.
Since the rules were first proposed, Congress has acted to ease the requirements somewhat by passing the Medicare Improvements for Patients and Providers Act, which excludes diabetes testing supplies from new competitive bidding requirements. CMS, however, responded with interim final rules aimed at effectively expanding competitive bidding to again include diabetes supplies sold at retail, and also proposed including diabetic supplies in a Medicare mail order program.
In addition, CMS issued a DMEPOS final rule that would have required pharmacies to obtain a surety bond to continue selling DMEPOS. And it isn’t cheap: the rule calls for pharmacy operators to post a $50,000 bond with CMS for every pharmacy outlet that supplies those products to Medicare patients under Part B.
Needless to say, it’s an expensive proposition, both for single-store independents struggling to stay profitable amid meager third-party prescription reimbursements, and for chains that may have to post insurance policies for every store selling diabetic supplies.
Considering the rules even include diabetic testing strips, how many of a pharmacy chain’s stores could be affected? Say, all of them?
That’s why pharmacy leaders are celebrating the enactment this week of H.R. 3663. It’s only a temporary reprieve, but the new law, signed by the president Oct. 13, shields community pharmacies from the new accreditation and bonding requirements through the end of this year.
That’s only two and a half months. Between now and then, the retail pharmacy lobby is pinning its hopes on supportive members of Congress. They must enact legislation to end, once and for all, this absurd exercise in redundant, excessive government regulation of a profession already fully licensed and qualified to supply pharmacy patients with the diabetic supplies and other health aids they need.
Actress Olympia Dukakis, husband to appear in diabetes ads
NEW YORK Passengers in New York taxis and viewers watching CNN at the airport will see actress Olympia Dukakis and her husband, Louis Zorich, talking about diabetes.
The appearance of the two actors won’t be in a movie, but in a public service announcement that’s part of drug maker Novo Nordisk’s “Ask. Screen. Know.” campaign to encourage diabetes awareness among the elderly.
FDA approves generic epilepsy treatment
PITTSBURGH Generic drug maker Mylan has received the Food and Drug Administration’s approval for its version of a drug used to treat epilepsy.
Mylan announced Thursday the approval of its topiramate sprinkle capsules in the 15-mg and 25-mg strengths. The capsules are designed to be opened and sprinkled onto soft food and are a generic version of Johnson & Johnson’s Topamax Sprinkle Capsules.
The branded version of the drug had sales of $58 million for the 12-month period ended June 30, according to IMS Health data.