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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 Medical Board Releases New Telehealth Rules

On Tuesday, February 21, 2023, the State Medical Board of Ohio released its final telehealth rules to implement Ohio’s telehealth statute (O.R.C. 4743.09) for physicians, physician assistants, dieticians, respiratory care professionals and genetic counselors. Ohio’s advanced practice registered nurses (“APRNs”) should also take note of these rules. While the Medical Board does not govern APRNs directly, those APRNs who are required to have a collaborating physician and standard care arrangement (namely nurse practitioners, certified nurse midwives, and clinical nurse specialists) are still affected by the rules. Generally, if an APRN’s collaborating physician is limited in their practice, then the APRN will also be limited.

The End of the Public Health Emergency is (Finally) Here

The COVID-19 Public Health Emergency (“PHE”) that has been in effect for over three years is finally slated to end on May 11, 2023.[1] With the end of the PHE will come many changes for healthcare providers to be aware of; however, some changes may not come until much later.

Multi-340B Contract Pharmacy Locations on the Brink? The Third Circuit’s Ruling Gives a Hint.

The 340B drug discount program requires pharmaceutical manufacturers to offer to sell their products at significant discounts to safety net providers called “covered entities.” In 1996, the Health Resources and Services Administration (HRSA) issued guidance authorizing covered entities to enter into a contract pharmacy arrangement with a single third-party contract pharmacy, to which the manufacturer would ship 340B medications but bill the covered entity. In 2010, HRSA issued revised guidance permitting covered entities to enter into an unlimited number of contract pharmacy arrangements.

Five Opportunities for Operations and Compliance Excellence in 2023

With the holidays behind us and the rest of the year ahead, now is the perfect time to get your operational/compliance house in order! Though your list might be a mile (or an inch) long, here are five places to start.

The Pregnant Workers Fairness Act - What Employers Need to Know

Effective June 27, 2023, the Pregnant Workers Fairness Act (PWFA) will require employers with at least 15 employees to provide reasonable accommodations for qualified employees with pregnancy-related restrictions unless doing so would impose an undue hardship on the employer.