Daniel B. Moskowitz

The FDA would have broad public support for a behind-the-counter (BTC) classification for drugs. According to the results of a telephone survey conducted by Leo J. Shapiro & Associates, 67% of respondents said they would welcome the convenience of obtaining a drug without a prescription and after counseling by a pharmacist, even while they recognize that their insurance plan would not cover the cost of the BTC medication.

The FDA does not allow pharmaceutical manufacturers to promote unapproved uses of their products, saying that evidence of success with additional indications can be given to physicians only if they request it. But the agency is on the verge of amending that rule to make it much easier for pharmaceutical companies to promote such prescribing.

In response to recommendations from the Government Accountability Office (GAO), the Centers for Medicare & Medicaid Services (CMS) says it is cracking down on insurers that offer private fee-for-service (PFFS) plans under the Medicare Advantage (MA) program.

Former Senate Majority Leader Thomas A. Daschle (D, SD) will become the nation’s health care policy czar with enormous influence on health care policy and reform. In addition to being named secretary of the vast 65,000-employee Department of Health & Human Services (HHS)-home of the FDA, the Centers for Medicare & Medicaid Services (CMS), and the NIH-

The federal government has less authority to set Medicare drug reimbursement prices than officials at the Centers for Medicare & Medicaid Services (CMS) had thought, according to a ruling by Judge Henry H. Kennedy Jr of the US District Court in Washington, DC, in a case (Hays v Leavitt [1:08-cv-01032-HHK]) filed by a person with chronic obstructive pulmonary disease. The patient, Ilene Hays, had received a prescription for DuoNeb, a combination inhalation drug made by Mylan’s Dey subsidiary.

A report from the Government Accountability Office (GAO) has led to new questions about the way health care for seniors covered under Medicare Advantage (MA) plans is paid for-and has prompted Centers for Medicare & Medicaid Services (CMS) acting administrator Kerry N. Weems to promise to collect more data from plans.

As more high-cost biologic drugs become part of standard care, the FDA has been under pressure to devise a way to allow generic versions of biologics to reach the market. Although competing industry interests have made it difficult for the agency and Congress to agree on such an approach, 2008 may be the year when that changes.

A proposal by the Centers for Medicare & Medicaid Services (CMS) published in the January 8 issue of the Federal Register would allow stand-alone Part D plans to offer reduced premiums to enrollees with limited incomes and resources-a rule intended to give such enrollees in each Medicare prescription drug benefit region at least 5 options with no monthly premium.

Sponsors of Part D plans are pressuring the Centers for Medicare & Medicaid Services (CMS) to shift its stand on e-prescribing, from encouraging physicians to voluntarily adopt the practice to mandating that they adopt it. "The time is now to require e-prescribing in Medicare. The only realistic way to rapidly accelerate adoption of e-prescribing is to require physicians to use the technology in Medicare," according to a statement released by the Pharmaceutical Care Management Association (PCMA). However, the AMA opposes such a mandate unless it includes federal grants or tax credits to help physicians pay for the necessary technology.