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New Executive Order regularizes process for promulgation of "significant guidance documents"

February 26, 2007

Last month, President Bush issued an Executive Order amending Executive Order 12866 on Regulatory Planning and Review.  OMB issued a Final Bulletin on Good Guidance Practices to implement the Executive Order.

The Order and Bulletin are aimed at reining in the proliferation of sub-regulatory guidance issued by federal agencies without any central review similar to the review required under E.O. 12866.

The key term in the order and bulletin is "significant guidance documents" as these are the documents that will require a closer look at OMB’s Office of Information and Regulatory Affairs ("OIRA").  OMB’s recommendation, but not requirement, is that agencies also provide advance notice to the public and solicit comment on significant guidance documents, in order to maintain a productive relationship with their regulated communities.

"Significant guidance document" is defined in part as:

a guidance document disseminated to regulated entities or the general public that, for purposes of this order, may reasonably be anticipated to . . .  [l]ead to an annual effect of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.

The recently issued and rescinded IDTF guidance certainly seems to fit within this definition.  Perhaps CMS will undertake such an approach when it reissues the IDTF guidance — which was supposed to take effect today — in some new form, as I expect it will in the not-too-distant future.

Update 4/6/07:  OIRA got a new administrator this week, courtesy of a recess appointment.  OMB Watch clearly has an axe to grind; it tags Susan Dudley as an "anti-regulatory extremis[t]."

— David Harlow 

Filed Under: CMS, Health care policy, Health Law, IDTF, Medicare

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