Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services reported in a recent edition of the Federal Register that it may suspend implementation of the interim final rule that would govern durable medical equipment (DME) bidding (Medical Device Daily, Feb. 17, 2009) in response to an executive order from the Obama administration, which suspended any executive branch activity pending review.

In yesterday's Federal Register, the agency indicates that the interim final rule (IFR) will indeed be suspended for 60 days, until April 18. Industry has indicated its ire that the publication of the IFR earlier this year fails to observe the 18-month moratorium Congress intended to impose on the program via the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008, but another question looms; whether Congress will act to scuttle DME bidding altogether.

Congress may not be inclined to utterly ignore the problem with DME fraud and abuse, especially given reports of tens of millions of dollars bilked by various scammers, not to mention concerns on the part of the Medicare Payment Advisory Commission about the waste in the program (MDD, Sept. 8, 2008), but remarks by a number of congressional Democrats indicate some hostility to the program itself.

In a hearing conducted May 6, 2008, Rep. Pete Stark (D-California), chairman of the health subcommittee for the House Ways and Means Committee, said it might be"simpler and much fairer" for CMS to reduce reimbursement amounts and to require all providers to undergo certification in lieu of a bidding program. According to Michael Reinemer of the American Association for Homecare (AAHomecare; Arlington, Virginia), Rep. Heath Shuler (D-North Carolina), was on record last week as suggesting that CMS"just scrap the program and start over."

Congress has heard routinely from the DME provider industry. One of the latest communiques came from Tyler Wilson, president of AAHomecare, who penned a Feb. 12 letter to Acting CMS Administrator Charlene Frizzera, which states that the passage of MIPPA was seen as having suspended the program until at least January 2010.

Wilson also states that the review process for bids used by CMS last year "lacked rules or guidelines, apparently leaving the decision-making to the contractor's discretion." He also made the case that industry's understanding of the 18-month suspension of the program"was so widespread in the days leading up to its enactment that we were surprised when CMS published the IFR."

Staffers for Stark and Sen. Chuck Grassley were unable to comment for the record.

Sibelius seen as likely HHS pick

The Obama administration is into the second round of nominees for the position of Secretary of Health and Human Services, and Kansas Gov. Kathleen Sibelius, a Democrat, is the object of rumors that she will run the vetting gauntlet next.

Sibelius has credentials where healthcare issues are concerned, given the eight years she served as the state's insurance commissioner and another six years running Kansas' state Medicaid program. She is widely seen as working very effectively across political divides.

Her success may or may not be assured, assuming she is nominated, but absent any financial imbroglios, she seems an almost sure bet.

Also on tap at HHS is the FDA commissioner position, a slot generally believed to hinge on the appointment of the HHS job. On the other hand, more bad news about drugs and food could override that sequence. The peanut salmonella problem and the recent disclosure that Raptiva (efalizumab), a treatment for severe placque psoriasis, has been linked to as many as four incidents of progressive multifocal leukoencephalopathy in the U.S. and Europe, puts a sense of urgency in the search for an FDA commissioner.

Baltimore Health Commissioner Joshua Sharfstein and Margaret Hamburg are frequently touted as the prime candidates. Hamburg served in a policy advisory role in the Clinton administration and as a health commissioner for New York City. The name of Steve Nissen, MD, a cardiologist at the Cleveland Clinic (Cleveland) and a frequent critic of FDA's regulation of the drug industry, seems to have dropped from view where the FDA post is concerned.

CVS to pay $2.25M over trash

CVS Caremark (Woonsocket, Rhode Island) recently learned the hard way that standard operating procedures matter in healthcare, even for pharmacy operations. The company has agreed to pay $2.25 million to settle charges that employees were disposing of pill bottles with patient labels in dumpsters. The Feb. 18 announcement by the Federal Trade Commission also noted that employees had trashed information such as medication instruction sheets, pharmacy order information, employment applications, payroll data, and credit card and insurance card information (MDD, Feb. 19, 2009).

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