Providers brace for new regulations on diabetes


Two steps forward, one and a half steps back. That's how Jim Schlicht, executive VP for government affairs and advocacy at the American Diabetes Association, described the impact of legislation and regulation on diabetes treatment.

A concerted education campaign convinced Congress to turn thumbs down on Senate Bill 1955, which would have exempted private insurers from state coverage requirements for diabetes and other chronic conditions.

An equally intense campaign failed to stop a Presidential veto of HR 810, the Stem Cell Research Enhancement Act. It would have eased restrictions that have hamstrung stem cell research in diabetes and other diseases in the United States.

"The Part D people at the Centers for Medicare & Medicaid Services don't talk to the Part B people," said John Coster, VP of policy and programs at the National Association of Chain Drug Stores. "You would think that the prescription drug benefit would dramatically improve care for diabetes, but the Part B change wipes out all the potential gains. Everybody in health care knows what to do to reduce the toll of diabetes, but politicians and regulators are slower to catch on."

CMS has not yet announced final regulations for the competitive acquisition program for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) that begins Jan. 1, 2007.

Early lists of products to be covered by DMEPOS included glucose meters and test strips. The prospect of competitive bidding on diabetes supplies raised a storm of protest from patient advocacy groups as well as pharmacists and other healthcare providers. They worry that competitive bidding will limit patient choices to a handful of the least expensive glucose meters and an equally short list of the lowest-cost test strips, which may or may not be compatible with available glucose meters.

Patients with diabetes now choose from more than 30 different glucose meters and 50 brands of test strips, according to a January 2006 report commissioned by NACDS. IMS Health sales data indicate that most patients over 65 opt for full-featured, brand-name items that are at the upper end of the price range for commercially available monitors.

Nearly two-thirds of Medicare-aged patients buy their meters and test strips from community pharmacies. The typical patient visits a pharmacy at least once a month for supplies or Rx diabetes meds, according to IMS. The pharmacy provides a single point of care with diabetes drugs, supplies, monitoring, and education.

"Diabetes supplies are part of a coordinated system of care," Coster noted. "You want to do all you can to integrate care, not fragment it. Taking diabetes supplies out of community pharmacies would fragment care."

CMS believes that 90% of current suppliers will bid to continue supplying DMEPOS, said William Popomaronis, R.Ph., VP for long-term care and home health care pharmacy services for the National Community Pharmacists Association. But an NCPA survey conducted earlier this year revealed that just 32% of community pharmacies would even bid. Even if all of the pharmacy bids were accepted, two-thirds of pharmacies now selling diabetes supplies would leave the business. Access would plummet.

"The cost just to bid is more than $2,500," Popomaronis said. "Costs for certification required by CMS under DMEPOS are anywhere from $5,000 to $15,000. That's a lot of money for a pharmacy selling test strips, meters, diabetic shoes, and self-management."

"Payers are starting to recognize that managing diabetes now saves money in the long run," Coster said. "But that's an evolutionary process, not revolutionary. Every payer has to make that realization on his or her own. A big part of our job is helping them figure that out."

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