May 2009

On May 28, 2009, the HHS Office of the National Coordinator for Health Information Technology (ONC) published a notice announcing a draft description of a program establishing regional extension centers to assist providers seeking to adopt and become meaningful users of health information technology, as required under the American Recovery and Reinvestment Act of 2009

Today CMS announced the general timeline for the next round of DMEPOS competitive bidding program:

Spring 2009

  • CMS Begins a Pre-Bidding Supplier Awareness Campaign
  • Program Advisory And Oversight Committee (PAOC) Meeting on June 4, 2009

Summer 2009

  • CMS Announces the Bidding Schedule and the Schedule of Supplier Education Events
  • CMS Begins Bidder Education Campaign

On May 27, 2009, the Food and Drug Administration (FDA) published a notice soliciting comments on a draft guidance document entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.”   The draft guidance proposes to use a “reasonable consumer” standard, similar to the Federal Trade Commission’s standard, for assessing whether advertisements are misleading, a

On May 20, 2009, Attorney General Holder and HHS Secretary Sebelius announced the creation of a new interagency effort, the Health Care Fraud Prevention and Enforcement Action Team (HEAT), to combat Medicare fraud. The HEAT team will include senior officials from Department of Justice (DOJ) and HHS who will build upon existing programs to combat

On May 20, 2009, CMS issued an updated educational article on DMEPOS supplier accreditation requirements to provide information for suppliers who choose not to become accredited. CMS notes that a DMEPOS supplier’s Medicare Part B billing privileges will be revoked on or after October 1, 2009 if the supplier fails to obtain accreditation or a

On May 26, 2009, the Federal Comparative Effectiveness Research Coordination Council announced that it is seeking comment on its draft definition of comparative effectiveness research and its draft prioritization criteria for comparative effectiveness research and investments. With regard to prioritization, the Council proposes to use the following criteria for determining “scientifically meritorious research and investments” 

CMS has released a draft version of the Minimum Data Set (MDS) 3.0 resident assessment instrument item set for nursing home residents. The final version is scheduled for publication in October 2009. In the May 12, 2009 proposed skilled nursing facility prospective payment rule, CMS has proposed requiring Medicare skilled nursing facilities and Medicaid nursing

The FDA has issued final guidance regarding formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research (note that the guidance does not apply to abbreviated new drug applications). 

The FDA has released a compliance guidance entitled “Labeling OTC Human Drug Products; Small Entity Compliance Guide.” The document, which finalizes draft guidance published in December 2004, is intended to help small businesses better understand and comply with the agency’s over- the-counter (OTC) labeling requirements and to prepare new labeling.

On May 20, 2009, the President signed into law the Fraud Enforcement and Recovery Act of 2009, which includes significant changes to the federal False Claims Act (FCA). Among other things, the new law expands the scope of FCA liability, provide for new investigative tools, and make it easier for qui tam relators to bring

The HHS Office of Inspector General (OIG) reports that in 2006, Medicare inappropriately paid a total net $178 million (out of $466 million) for chiropractic services that reviewers determined to be maintenance therapy, miscoded, or undocumented. The OIG recommends that CMS take a number of steps to address continuing vulnerabilities in this area, including implementing a