HEALTH

Efforts to combat Medicare fraud draw mixed signals from indies, PBMs

BY Jim Frederick

WASHINGTON The independent pharmacy and pharmacy benefit management industries both praised new efforts by Congress and the Obama administration to end the fraudulent and abusive billing practices that plague Medicare and Medicaid and cost U.S. taxpayers tens of billions of dollars. But their recommendations for combating the problem are as different as their approaches to the pharmaceutical market.

The Centers for Medicare & Medicaid Services proposed new regulations to help prevent what the agency said is $55 billion in annual improper payments to providers and health plans. In a related development, the House Energy and Commerce Subcommittee on Health is looking at ways to attack the problem, and held a hearing Thursday titled, “Cutting Fraud, Waste and Abuse in Medicare and Medicaid.”

The National Community Pharmacists Association weighed in with a statement to the House panel that accused the pharmacy benefit management industry of responsibility for much of the abuse, which the group attributed to a “past record of alleged systematic chicanery.”

In its statement, the independent pharmacy lobby reminded lawmakers of numerous allegations of fraud by major PBMs, as well as “misrepresentation to plans, patients and providers; improper therapeutic solutions; unjust enrichment through secret kickback schemes; and failure to meet ethical and safety standards.” The group urged Congress to pass legislation “to rein in the waste being generated by the business practices of pharmacy benefit managers under Medicare and Medicaid,” and to increase the transparency of PBM audit practices.

Not surprisingly, the response from the Pharmaceutical Care Management Association, the main PBM industry advocacy group, was markedly different. Responding to new proposed regulations from CMS to combat fraud and abuse, PCMA president and CEO Mark Merritt said the government’s focus should be on preventing abuse rather than on pursuing wrongdoers after the fact for fraudulent billing practices. “Pharmacy benefit managers agree that prevention, not ‘pay and chase,’ is the key to fighting fraud,” Merritt noted. “Unfortunately, some public policies undermine the fight against fraud by requiring payers to include pharmacies in their networks that have been banned from federal programs.”

Merritt also reiterated PCMA’s call for legislation to eliminate legislative “prompt-pay” requirements that force pharmacy benefit plans to quickly pay prescription claims, raising again a major source of friction between the PBM and retail pharmacy industries. Policies that require payers to “accelerate payments,” PCMA’s leader charged, leave “less time to detect and prevent fraudulent Medicare claims before payments are made.”

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HEALTH

FDA approves multiple sclerosis drug Gilenya

BY Alaric DeArment

SILVER SPRING, Md. The Food and Drug Administration has approved a drug for reducing relapses in patients with multiple sclerosis.

 

The FDA announced Wednesday the approval of Swiss drug maker Novartis’ Gilenia (fingolimod) capsules, saying it was the first oral drug that can slow the progression of disability in patients with MS and offered an alternative to injected drugs.

 

 

Around 400,000 people in the United States and 2.1 million worldwide have MS, according to the National Multiple Sclerosis Society.

 

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Novartis’ Cushing’s disease drug shows promising results in trial

BY Alaric DeArment

EAST HANOVER, N.J. Swiss drug maker Novartis said its investigational drug is the first to show promise in a late-stage clinical trial for Cushing’s disease, a potentially fatal hormonal disorder.

 

Novartis announced Wednesday that the drug SOM230 (pasireotide) had reduced cortisol levels in patients with Cushing’s disease. The disease results from a benign pituitary tumor that causes the adrenal glands to produce excess cortisol. This can lead to metabolic and cardiovascular problems and death. Results will be presented at the 14th congress of the European Neuroendocrine Association.

 

 

“There is a critical need for a medical treatment for people with Cushing’s disease because currently available options, such as surgery or radiotherapy, are ultimately not effective for many of the patients who suffer from this debilitating disease,” said William Ludlam, director of the Seattle Pituitary Center at the Swedish Neuroscience Institute in Seattle. “The results of this study suggest that pasireotide may help patients achieve biochemical control of their Cushing’s disease and its symptoms by directly targeting the pituitary tumor that triggers excess cortisol production.”

 

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