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HHS Proposes to Review Its Regulations Every Ten Years

On November 4, 2020, the Department of Health and Human Services (“HHS”) proposed a new rule that would require HHS to review many of its regulations every ten years. HHS proposed the new rule pursuant to the Regulatory Flexibility Act (“RFA”), which was enacted under President Carter in 1980. Under the proposed rule, every ten years, HHS would review a regulation to determine whether it is still needed, whether it is having the appropriate impacts, and whether it ought to be revised or rescinded. Regulations that are not timely reviewed would expire.

Nearly all regulations would undergo a two-step review. HHS would first determine whether the RFA applies to a regulation by assessing whether they have a significant economic impact on a substantial number of small entities. If the RFA applies, HHS will then conduct a more detailed review of the regulation and consider: (1) the continued need for the rule, (2) complaints about it, (3) the rule’s complexity, (4) the extent to which it duplicates or conflicts with other rules, and (5) whether technological, economic, and legal changes favor amending or rescinding the rule. Public comments will be accepted as part of this review process.

The following regulations will not be subject to this review: regulations that are jointly issued with other agencies, regulations that legally cannot be rescinded, and regulations issued with respect to a military or foreign affairs function or addressed solely to internal management or personnel matters. Regulations that affect the regulations of other agencies will be reviewed in conjunction with those agencies.

Any rules that are more than ten years old at the time the final rule is implemented will be reviewed within two years. HHS estimates that approximately 2,480 rules fall into this category. HHS also estimates that the total costs of the review will be between $10 and $26 million over ten years.  It remains to be seen whether this increase in review activity will lead to meaningful reduction or optimization of HHS regulations, and whether more frequent reviews and revisions of regulations will lead to increased uncertainty and costs. These concerns may be especially present during the initial two years. However, these concerns are likely to recede over time because reviews are only conducted every ten years and would allow public comment on burdensome or ineffective regulations. Public comments on portions of the proposed rule itself will close December 4, 2020, while public comment on portions pertaining the Medicare will close January 4, 2021.

For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in Medicare and Medicaid policies. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or

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