HHS Lays Out Regulatory Schedule

HDM Breaking News, May 11, 2009

The Department of Health and Human Services has published its semi-annual regulatory agenda, showing actions the department intends to take in coming months.

The agenda was comparatively light when last published in November as the Bush Administration was winding down; it remains light as the Obama Administration gears up.

Under the new agenda, a proposed rule to require electronic submission to the Food and Drug Administration of clinical trial data in standardized formats remains on track for September 2009. A publication date for the long-delayed final rule for adopting standard electronic claims attachments remains to be determined. HHS published the proposed attachments rule in September 2005.

Proposed rules making changes to prospective payment systems for 2010 covering hospital inpatient and long-term care, hospital outpatient and ambulatory surgical centers, and skilled nursing facilities are expected within the next two months. Revisions to payment policies under the physician fee schedule for 2010 also are expected in that timeframe. However, deadlines for anticipated actions are not always accurate.

At last month's HIMSS Conference in Chicago, David Hunt, M.D., CMO in the office of health I.T. adoption in the office of the national coordinator for health information technology, said the coming Medicare payment rules could start to clarify what "meaningful use" of electronic health records means. Or those rules could be "vehicles" for publishing proposed definitions, he added. Another option is the proposed definitions could be published in a separate rule.

The HHS semi-annual regulatory agenda is available in the May 11 Federal Register at gpoaccess.gov/fr/index.html.

--Joseph Goedert

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