by Kristin Rowan, Editor

The Administrative Procedure Act (APA) requires that an agency public a notice of proposed rulemaking in the Federal Register; allow sufficient time for public participation via written data, views, or arguments; and then publish a final rule. Matters relating to agency management, personnel, or public property; loans, grants, benefits, or contracts; and for “good cause” are exempt from the reporting requirements. The Richardson Waiver, adopted in 1971, waived the exemption and instructed agencies to use the good cause exemption sparingly. Effective immediately, the Richardson Waiver is rescinded.

Public participation is now optional. Agencies and offices of the Department of HHS can, if desired, use the public notice and comment procedures for these matters, but are no longer required to do so. The Department will continue to follow these procedures in all circumstances in which they are required to do so.

Law firm Hogan Lovells, experts in healthcare law, wrote about the potential implications for the health care industry in a recent blog post. According to the firm, it is unclear how HHS will interpret the “benefits” portion of the exemption. HHS, and specifically CMS, currently uses the notice and comment procedure for various benefits programs, including Medicare and Medicaid. Secretary Kennedy’s statement clearly calls out the limitation in impacting any other law requiring notice and comment periods.

Hogan Lovells indicates that few if any policies written under the Medcare Act will be impacted by this change. The Medicare Act operates under additional rulemaking requirements under section 1871(a) of the SSA. Additionally, Azar v. Allina Health Services, 587 U.S. 566 (2019) confirms that Medicare rulemaking is independent from the APA. Some policies are currently exempt from the notice and comment obligations under the Medicare Act and will remain exempt.

Medicare and CHIP fall under Title XIX of the SSA, which does not contain its own notice and comment requirements separate from the APA. HHS has used the APA notice and comment rules for many of the changes made to the Medicaid program. HHS could interpret the “benefits” clause as exempting Medicaid changes from the rule. Hogan Lovells states it is currently unclear whether HHS will take this route. They also purport the courts have not ruled on whether APA excludes Medicaid from the notice and comment requirements, and may not agree with that exclusion. Until the term “benefits” is better defined, Medicaid, CHIP, the insurance exchange marketplace, and TANF, among others, may be impacted.

A notable exception to these changes is the rulemaking in the Department of Veterans Affairs as it relates to the Veterans Health Care act of 1992. This program implemented Federal contractor requirements that established pricing and contracting standards for drug manufacturers. The VA policies and rules have historically been enacted using guidance letters, avoiding the rulemaking process altogether.

There is too much that is yet unknown regarding this change to understand its full impact. There will be immediate changes, court rulings, further changes, and likely a lot of advocacy from national organizations fighting for transparency for Medicare, Medicaid, and other “benefit” programs. This will be an ongoing story and The Rowan Report will bring updates as they happen.

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Kristin Rowan has been working at The Rowan Report since 2008. She is the owner and Editor-in-chief of The Rowan Report, the industry’s most trusted source for care at home news .She also has a master’s degree in business administration and marketing and runs Girard Marketing Group, a multi-faceted boutique marketing firm specializing in content creation, social media management, and event marketing.  Connect with Kristin directly kristin@girardmarketinggroup.com or www.girardmarketinggroup.com

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