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CMS meeting to cut rates for non-mail diabetes supplies draws industry criticism

BY Michael Johnsen

ALEXANDRIA, Va. — The Centers for Medicare and Medicaid Services on Monday hosted a public meeting to entertain a controversial payment adjustment — called "inherent reasonableness" — in reimbursing for non-mail-order diabetes supplies.

According to published reports, CMS’ authority to make payment adjustments was finalized in 2005 and can be invoked if existing reimbursements are deemed to be grossly excessive. The action comes out of the competitive bidding process for mail order, which resulted in prices more than two times lower than those for diabetic supplies sold at retail establishments.

"Although we recognize that there are pricing differences between mail-order and non-mail order diabetic testing supplies because of the delivery methods for these supplies, information about the prices of mail-order diabetic testing supplies can inform the analysis of prices for non-mail order diabetic testing supplies because several key cost components are identical for both, such as product acquisition costs and administrative costs, including claims processing and paperwork costs," the agency stated in the Federal Register in announcing the public meeting last month.

"Rather than phasing in non-mail-order diabetic testing supplies under the competitive bidding program at this time, we are considering an alternative for adjusting the payment amounts for non-mail-order diabetic testing supplies in the short term using information obtained from the local Round One Rebid competitions for mail-order supplies and other pricing information to establish special payment limits for non-mail-order diabetic testing supplies," the agency continued. "We believe that this alternative would allow beneficiaries the greatest degree of choice in deciding where to obtain their non-mail-order diabetic testing supplies as suppliers would not have to be awarded contracts to continue furnishing these items to Medicare beneficiaries."

“Community pharmacists are indispensable to helping combat diabetes, whether it is the counseling they offer, the medications they dispense, the lifestyle modification classes they provide or the wide variety of testing supplies they carry,” stated Bill Popomaronis, VP LTC/HHC/NIPCO for the National Community Pharmacists Association, during the meeting this morning. “However, that dynamic will be harmed if these small business pharmacies are forced to walk away from a pricing structure for diabetic testing supplies that only a large self-warehousing chain pharmacy or mail-order supplier can make work.” He warned the policy would produce financially unsustainable reimbursement cuts for independent community pharmacies.

The policy comes on the heels of other impediments to selling diabetes testing supplies under Medicare Part B, as CMS has proposed "burdensome and expensive requirements" while working with a secondary payer to receive slow reimbursements, Popomaronis added.

In his testimony, Popomaronis detailed the concerns that come with the “inherent reasonableness” standard, which, according to an NCPA press statement, include:

  • Reimbursement reductions that are financially unsustainable because small pharmacies cannot purchase the supplies in bulk like the large chains or mail-order suppliers;

  • A lack of evidence that the fee schedule is grossly excessive as compared with the cost to independent pharmacies to purchase these supplies;

  • The misguided notion by CMS that savings and success for diabetic patients necessarily means driving down per unit costs, which may be contrary to the integrated care models being promoted by healthcare systems in the public and private sector; and

  • A failure to acknowledge the money CMS wastes on mail-order diabetes testing supplies that are shipped, as demonstrated by the large amount of unused prescription drugs generated by mail-order supplies in the One Year Implementation Update to Round 1, and further confirmed by CMS’ own Jonathan Blum, who suggested the competitive bidding program decrease in utilization of mail-order diabetes testing supplies could lead one to infer that community pharmacies could serve patients better than mail order.


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Study: Long-term use of linagliptin among Type 2 diabetics is effective

BY Allison Cerra

NEW YORK — Extended use of the oral DPP-4 inhibitor linagliptin to lower blood-glucose levels by Type 2 diabetes patients is effective, according to a new study.

A team of eight researchers — four of which work for drug maker Boehringer Ingelheim — examined 2,121 Type 2 diabetes patients that had taken part in four previous 24-week randomized, double-blind, placebo-controlled trials in order to monitor them for a further 78 weeks. The participants who took part in the extended trial came from 231 sites in 32 countries.

In an effort to measure the effective of linagliptin as a monotherapy or in combination with other selected oral antidiabetic medications, subjects who had previously received linagliptin (1,532) continued to do so and those who had received the placebo during the earlier trials (589) also were given the drug during the 78-week trial extension. Linagliptin was administered orally once a day in all cases, either on its own, or in combination with metformin or metformin plus a sulphonylurea or pioglitazone.

"Initial 24-week trials showed that linagliptin, either on its own or with other glucose-lowering agents, was effective in improving glycaemic control without weight gain or an independent increased risk of hypoglycemia," said co-author David Owens, professor emeritus and the Centre for Endocrinology and Diabetes Sciences at Cardiff University in Wales. "Linagliptin works by blocking the action of DPP-4, an enzyme that destroys the hormone GLP-1, which helps the body produce more insulin when it is needed."

The researchers found that long-term treatment with linagliptin was well-tolerated with no change in the safety profile observed during the extension study. Those that received linagliptin in the previous studies saw a reduction of 0.8% in their HbA1C levels. Additionally, sustained long-term glycemic control was maintained for up to 102 weeks with either linagliptin monotherapy or linagliptin in combination with other oral glucose-lowering agents. The study findings were published in the International Journal of Clinical Practice.

"Findings from the 78-week open-label extension involving 2,121 people with Type 2 diabetes demonstrate sustained glycemic control for up to 102 weeks treatment duration," Owens said. "They also provide evidence that supports the efficacy and tolerability profile seen in previously reported 24-week studies. Therefore this extension study shows that linagliptin is an effective and well tolerated therapy for the long-term management of Type 2 diabetes."


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Pharmacists, retail clinicians have role to play in stopping pertussis epidemic

BY Alaric DeArment

WHAT IT MEANS AND WHY IT’S IMPORTANT — With pertussis rising at alarming rates across the country, now is a better time than ever for pharmacists to step in and do their part to quash the epidemic.

(THE NEWS: "CDC: National pertussis rates are on the rise." For the full story, click here.)

Pertussis, also known as whooping cough, once was a deadly scourge for children in the United States, but vaccinations have long helped keep it under control. Now, states like Washington are seeing rates reminiscent of the 1940s.

This has prompted efforts to curb the epidemic on the part of health authorities and retail pharmacy chains, but one important link that’s often missing is getting adults vaccinated. According to a Harris Interactive survey conducted in May 2012 on behalf of the Sounds of Pertussis Campaign, a joint initiative by March of Dimes and Sanofi Pasteur, most parents aren’t asking adults close to their children to get adult whooping cough booster vaccines.

While the survey found that 83% of parents with children ages 2 years and younger considered vaccination important for adults in contact with infants and young children, only 19% reported asking friends and family in close contact with their children to get an adult pertussis vaccination. And according to the Centers for Disease Control and Prevention, only about 10% of adults reported receiving an adult pertussis vaccine.

This is an area in which pharmacists and retail clinicians can be especially helpful, given their accessibility to the broader community. Because most retail pharmacists can now deliver vaccinations, they can prominently advertise pertussis vaccinations in stores and urge customers to get them. The Harris Interactive poll found that 61% of parents said they would feel awkward asking a family member or caregiver to get an adult pertussis vaccine, but pharmacists carry more authority on matters related to health, and they may have an easier time talking adults into getting vaccinated.

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