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HHS Revokes Public Comment Requirement on Certain Policy Changes

Client Alert

The U.S. Department of Health and Human Services (HHS) has announced the immediate revocation of the longstanding Richardson Waiver, a policy requiring public notice and comment on certain agency decisions involving contracts, grants, benefits, property, and public loans. This move, detailed in a March 3 policy statement by HHS Secretary Robert F. Kennedy Jr., eliminates a key mechanism for stakeholder input on agency policy shifts.

Key Policy Changes

The elimination of the Richardson Waiver means that HHS will no longer be required to allow a 60-day public comment period before finalizing policy changes related to grants and benefits. As a result, HHS will now have the ability to implement new policies much more quickly, potentially impacting Medicaid and National Institutes of Health funding rules. This change eliminates opportunities for healthcare providers and other stakeholders to weigh in on crucial policy decisions – like implementing Medicaid work requirements – before they take effect. This change does not impact Medicare, which follows separate statutory public input rules and remains subject to different procedural requirements.

Industry groups have expressed concerns that eliminating public comment could lead to less transparency and hastily implemented policies that lack sufficient vetting. Without an opportunity for public review, new regulations may be more prone to unintended consequences, creating additional burdens for states, providers, and patients.

What This Means for Healthcare Providers

Healthcare providers and other stakeholders should prepare for more rapid and potentially unpredictable policy shifts from HHS. The absence of a formal comment process means that affected entities may need to explore alternative advocacy strategies to engage with policymakers.

We will continue to monitor developments and provide updates on any significant policy changes stemming from this decision. Please contact BMD Healthcare Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com with any questions about how this may impact your organization.


Ohio Board of Pharmacy Update: Key Regulatory Changes and Proposals You Need to Know

The Ohio Board of Pharmacy (BOP) has rescinded certain OAC rules (OAC 4729:5-18-01 through 4729:5-18-06), removing regulations on office-based opioid treatment (OBOT) clinics. The rescissions took effect on June 3, 2024. The BOP also published a new rule, OAC 4729:8-5-01, which sets explicit reporting guidelines for licensed dispensaries and became effective on June 7, 2024.

LGBTQIA+ Patients and Discrimination in Healthcare

In early April, the Kaiser Family Foundation released a study outlining the challenges that LGBT adults face in the United States related to healthcare. According to the study, LGBT patients are “twice as likely as non-LGBT adults to report negative experiences while receiving health care in the last three years, including being treated unfairly or with disrespect (33% v. 15%) or having at least one of several other negative experiences with a provider (61% v. 31%), including a provider assuming something about them without asking, suggesting they were personally to blame for a health problem, ignoring a direct request or question, or refusing to prescribe needed pain medication.”

Ohio Recovery Housing Overhaul: New Standards and Certification Requirements Reshape Sober Living Spaces

Ensuring Fair Access: SB 269 Protects Affordable Medication for Low-Income Patients

SB 269, introduced on December 19, 2023, will ensure that 340B covered entities, including Federally Qualified Health Centers, Ryan White Clinics, disproportionate share hospitals, and Title X clinics, can acquire 340B drugs without facing undue restrictions or discriminatory practices from drug manufacturers and distributors. This protection is crucial for 340B covered entities to continue to provide affordable medications and comprehensive services to low-income patients.

Unveiling Ohio's Pharmacy Board Updates for Distributors, Mobile Clinics, and Controlled Substances

The Ohio Board of Pharmacy will hold a public hearing on May 28, 2024, to discuss several proposed changes and additions to Ohio Administrative Code (OAC). These changes pertain to terminal distributors of dangerous drugs (TDDDs), mobile clinics or medication units, and the classification of controlled substances.