Published 1/1/2008

Second Look: Reimbursement & Regulation

If you missed these news items the first time around, AAOS Now gives you a second chance to review them. Links are available online at www.aaos.org/now. Headline News Now, the AAOS thrice-weekly, online update of news of interest to orthopaedic surgeons, brings you the latest on clinical, socioeconomic, and political issues, as well as important announcements from AAOS.

FDA takes steps to increase committee transparency
The FDA has issued several draft-guidance documents containing proposals for changing the agency’s advisory-committee processes to increase transparency and reduce conflicts of interest. Recommendations include simultaneous voting by advisory-committee members, with immediate announcement of vote results, followed by public disclosure of vote results. Advisory-committee members must also publicly disclose conflicts of interest for which a waiver is granted. Disclosure and waiver templates have been redesigned to be clearer and easier for the general public to understand. The proposed changes are in accordance with recommendations from the US Institute of Medicine.

CMS postpones part of Stark III
According to Modern Healthcare (free site registration required), the US Centers for Medicare and Medicaid Services (CMS) plans to delay implementation of a portion of the Stark-law prohibitions against physician self-referral. The final rule will go into effect on Dec. 4, 2007, as planned, with the exception of the “stand-in-the-shoes” provision as it applies to academic medical centers and not-for-profit healthcare systems, which will be granted a reprieve of 1 year. The new rule tightens an exception applied to indirect financial relationships between physicians and hospitals through which they refer patients for certain services reimbursed by Medicare. Under the new rule, the physicians would be considered to stand in the shoes of their practice. The reprieve was prompted by comments arguing that restructuring support payments that are routine in faculty-practice plans and not-for-profit systems would have placed an undue strain on some facilities struggling to meet the other requirements of Stark.

HHS Secretary wants to tie reimbursement to EMRs
According to the Associated Press, “US physicians should be required to adopt electronic record keeping if they want to avoid the 10.1 percent reduction in Medicare reimbursement scheduled for 2008,” said US Secretary of Health and Human Services Mike Leavitt on December 3. “In my view,” Leavitt said, “any new bill should require physicians to implement health-information technology that meets department standards in order to be eligible for higher payments from Medicare.” Supporters of electronic medical record (EMR) adoption contend that EMRs will reduce medical errors and cut costs through increased efficiency. Upfront costs for EMR systems can run from $20,000 to $40,000 in a small practice.

The AAOS has an educational initiative on EMRs available through the Academy’s online Practice Management Center (member login required). A free copy of the EMR primer and a free podcast are among the resources available on the site.

Supreme Court looks at medical-device liability
According to the New York Times, the US Supreme Court is reviewing a case that could determine whether the manufacturer of a medical device can be held accountable for the failure of that device if it has been granted FDA approval. At issue is a balloon catheter that burst during an angioplasty. Two federal courts previously dismissed the suit, saying that FDA approval precluded the imposition of liability under state law. A lawyer for the manufacturer argues that allowing the suit to continue could “discourage the marketing of products that might save our lives.” Another expert counters that a preliminary judgment of safety and effectiveness should not relieve a manufacturer of the obligation to make a device better and safer.