As the new Congress returns to Washington, already itching for a fight over the repeal of all or parts of President Obama's health care reform law, federal agencies have been busy issuing regulations to implement parts of the primary reform legislation, the Patient Protection and Affordable Care Act (PPACA). According to a December 10, 2010, report issued by the Congressional Research Service, as of December 7, 2010, federal agencies have issued 18 of the nearly 40 regulations that are either specifically required by PPACA or are permitted by the law.

The vast majority of these regulations were issued in final form, without public comment, taking advantage of an exception under federal law to the normal requirement of “notice and public comment” before a rule can become final. That exception permits the issuance of final rules, with a post-effective-date public comment period, where “good cause” exists for issuing a final rule without prior public comment or notice. Where regulations are issued without the chance for prior public comment, they are known as “interim final rules” but are final nonetheless, unless the implementing agency, based upon post-effective-date public comments, elects to modify the rule. The Congressional Research Service report candidly admits that the likelihood an “interim final rule” issued without prior public comment will later be modified is much smaller than if the rule had been issued as a “proposed” rule with prior public comment.

Only a handful of the 18 regulations issued under PPACA to date are specifically required by the law. The rest were simply “permitted,” or the agency charged with implementing that part of PPACA has asserted that the law gave them authority to issue regulations, evidencing the enormous scope of the statute.

Some of the more important regulations issued under PPACA to date include regulations:

At the same time, states are busy determining what changes in statutes or regulations will be necessary, or are simply permitted, to implement various state obligations under PPACA. In North Carolina, the N.C. Institute of Medicine has developed a number of task forces looking at various aspects of health care delivery in the context of the health care reform law, including fraud and abuse, workforce issues, payment, and clinical issues, among others. These task forces will eventually make recommendations to the N.C. Department of Health and Human Services, the N.C. Department of Insurance, and other state agencies about statutory revisions, rule changes or policy changes they view as necessary to implement PPACA in North Carolina or as permitted under the law. Members of Poyner Spruill's Health Law Section currently sit on several of these IOM task forces.

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