NYLAG Submits Comments on proposed CMS "Sunset" Regulation - Rule Adopted January 8, 2021

JAN 8, 2021 Update - The Trump Administration adopted a final rule - PDF  finalizing, with some changes, the proposed rule that NYLAG and many other organizations commented on, described below.  

In its last days, the Trump Administration is continuing to try to sabotage the incoming Administration by tying the hands of new agency leadership and rolling back longstanding regulations.   The US Dept. of Health & Human Services (HHS) has proposed a "sunset regulation" that would retroactively impose a mandatory expiration date on an estimated 18,000 duly promulgated regulations for programs ranging from Medicaid and Medicare to the FDA and CDC. Even long-standing rules would be automatically rescinded unless they survive a complex process of assessment and review. Programs like Medicaid and the Children’s Health Insurance Program (CHIP) could be devastated if important regulations are arbitrarily rescinded.  NYLAG has joined the National Health Law Program and other organizations in submitting comments, pushing back against this unlawful and ill-conceived proposal designed to sabotage HHS safety net programs.

See NYLAG comments on propsed rule

See National Health Law Program comments on proposed rule

 HHS' announcement of the final rule  

HHS states:
"...All HHS regulations, with certain exceptions  will be subject to a two-step review: 1) assessing whether they have a significant economic impact on a substantial number of small entities, the standard set out under the RFA; and, if it qualifies for review under the RFA, 2) a more detailed review that will consider, as prescribed in the RFA, (i) the continued need for the rule, (ii) complaints about it, (iii) the rule’s complexity, (iv) the extent to which it duplicates or conflicts with other rules, and (v) whether technological, economic, and legal changes favor amending or rescinding the rule.
Rules issued by an HHS component that are more than ten years old need to be reviewed within five calendar years of the effective date of this final rule, making the effective date of considerable substantive significance because it starts the clock for reviews. By providing five calendar years from the effective date, rather than two as proposed, private entities have over five years to become accustomed to, and participate in, the review process.

What are the key differences between the proposed and final rule?
The final rule (1) extends from two years to five years the deadline for assessing and reviewing regulations that are more than 10 years old, (2) allows the Secretary to extend the review deadline one time per regulation by up to one year, (3) exempts certain device, food, and OTC drug-specific regulations, (4) exempts the annual Notice of Benefit and Payment Parameters update rules, (5) requires the Department to announce in the Federal Register (not just on the HHS website) each month which new assessments and reviews it has begun, and (6) allows the public to comment on assessments and reviews via the regular Regulations.gov procedures.

FOR MORE INFORMATION

To learn more, check out these blogs posts from Georgetown Health Policy Institute Center for Children & Families and the Center for Budget and Policy Priorities.

****************************************************************************************

See other recent comments NYLAG has submitted:



08 Jan, 2021
NYLAG Submits Comments on proposed CMS "Sunset" Regulation - Rule Adopted January 8, 2021
http://www.wnylc.com/health/news/88/