A Medical Device Daily

Sen. Chuck Grassley (R-Iowa) reportedly has sent a letter to the Government Accountability Office requesting an investigation of how not-for-profit hospitals comply with laws that require them to provide community benefits in exchange for tax-exempt status and other tax breaks.

Grassley asked GAO to investigate what community benefit standards states have established, as well as those established by the Internal Revenue Service, and what guidelines hospitals use to interpret the community benefit standard. In addition, Grassley requested that GAO examine hospital executives' and board members' compensation and the extent to which they are involved with for-profit business ventures with the not-for-profit hospitals.

The investigation is part of a series of hearings on charities and the breaks they receive under the tax code.

Grassley said that because of the "generous" tax breaks that non-profit hospitals received, there was a need to better understand how these hospitals are fulfilling the mandate for providing public service. He said that this is especially important with increasing discussion of medical care to the uninsured.

Blunt-tip needle use urged

The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (Atlanta) have published a Safety and Health Information Bulletin (SHIB) recommending broad use of blunt-tip needles designed to protect surgical personnel from needle stick injuries while using suture needles.

The SHIB is available on the OSHA Web site at:

http://www.osha.gov/dts/shib/shib032307.html and on the NIOSH Web site at:

http://www.cdc.gov/niosh/docs/2007-132.

The sites present evidence of the effectiveness of blunt-tip needles in decreasing injuries and emphasize OSHA's requirement to use appropriate, available and effective safer medical devices.

Sharp-tip suture needles are the leading source of penetrating injuries to surgical personnel, causing 51%-71% of these incidents.

Edwin Foulke Jr., assistant secretary of labor for OSHA, said in a statement, "We strongly encourage the use of blunt-tip suture needles when feasible and appropriate to reduce this risk."

"The effectiveness of blunt-tip suture needles for preventing needle stick injuries has been widely reported," said John Howard, MD, director of NIOSH. "We are pleased to partner with OSHA in offering guidance to protect the safety and health of medical professionals."

The American College of Surgeons (ACS) issued a statement in 2005 supporting the use of blunt-tip suture needles where clinically appropriate. This statement has been endorsed by the six organizations that, along with the ACS, make up the Council on Surgical and Perioperative Safety.

CMS revises clinical trial coverage rules

The Centers for Medicare & Medicaid Services (CMS) has reported proposed revisions to the Clinical Trial Policy national coverage determination (NCD) related to certain items and services for Medicare beneficiaries involved in clinical trials.

"This new decision will signal our continued support to provide access to services for beneficiaries by facilitating participation in the full range of qualified, scientifically sound research projects," said CMS Acting Administrator Leslie Norwalk.

In developing the revised clinical trial policy, CMS convened the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) last December. The MedCAC proposed several recommendations, subsequently reviewed by a federal panel led by the Agency for Healthcare Research and Quality (AHRQ). In addition to AHRQ, the federal panel included representatives from CMS, FDA, CDC, HRSA and the NIH.

The new rules include:

  • Renaming the policy as the Clinical Research Policy;
  • Adding FDA post-approval studies and coverage with evidence development (CED) to studies that would qualify under this policy;
  • Requiring all studies to be registered on the NIH ClinicalTrials.gov website before enrollment begins;
  • Requiring studies to publish their results;
  • Paying for investigational clinical services if they are covered by Medicare outside the trial or required under a CED through the NCD process;
  • and expanding the "deeming" agencies to all Department of Health and Human Services agencies, the Veterans Administration, or the Department of Defense. Deeming agencies are agencies that can "deem" whether a trial has met the general standards outlined in the policy.

"This proposed Clinical Research Policy exemplifies the Agency's commitment to providing access to services for beneficiaries by encouraging the conduct of research studies that add to the knowledge base about the efficient, appropriate, effective, and cost-effective use of products and technologies in the Medicare population, thus improving the quality of care that Medicare beneficiaries receive," Norwalk said.

The proposed NCD opens a 30-day comment period. CMS will review all the public comments and suggestions received and incorporate them into a final NCD. CMS will publish the final NCD no later than sixty days after the end of the comment period. The revised policy will be effective with the publication of the final NCD.

Details of the policy are available at the CMS website: www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186.