Full article reprinted from "The Gray Sheet" - January 26, 2009
Find out how in one of his first acts after taking office, President Obama temporarily halted issuance of regulations from all federal departments and agencies until his own appointees have signed off on the rules.
The Jan. 20 1memo, signed by Chief of Staff Rahm Emanuel, is designed to halt policies that were pushed through in the last weeks and days of the Bush administration but that don't align with Obama's platform. Many less controversial rules, including those from the Department of Health and Human Services, may also be delayed.
The memo instructs current department and agency heads not to send any new proposed or final rules to the Federal Register, and to withdraw rules that have already been sent to the Office of the Federal Register but were not yet published. Further, it asks them to "consider extending for 60 days the effective date of regulations that have been published in the Federal Register but have not yet taken effect." It offers exceptions for emergencies or "other urgent circumstances relating to health, safety, environmental, financial, or national security matters, or otherwise," as judged by Obama's Office of Management and Budget team. The freeze also does not apply to regulations subject to statutory or judicial deadlines.
One set of rules that could be impacted require the implementation of the new ICD-10 coding system for health insurance claims. Two rules (one for needed information technology standards updates and one for actual implementation of ICD-10) were issued earlier this month, but do not take effect until March. The rules lay out a plan for adoption of the almost ten-fold increase in codes by 2013 (2"The Gray Sheet" Jan. 19, 2009, In Brief).
On the FDA front, there are no major pending rules for devices, though there is potential for some efforts, such as device reclassifications, to be delayed. Balloon angioplasty catheters and digital mammography are among products for which proposed or final rules are pending on down-classification from Class III (PMA) to Class II (510(k)) (3"The Gray Sheet" June 16, 2008, p. 3).
- David Filmore
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