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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.


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.

Valley National Bank/Trulieve Loan: A Big Step Out of the Shadows

In a late December press release, Trulieve announced that it had secured a $71.5 million commercial bank loan. In addition to the amount of the loan, which may be the largest commercial bank loan to date to a cannabis company, the release prominently identified Valley Bank and featured both a quote from Valley’s Senior Vice President, John Myers, and a description of the Bank’s service platform and commitment to the cannabis industry.

The End of Non-Competes? The Impact It Will Have on the Healthcare Industry

On January 5, 2023, the Federal Trade Commission (“FTC”) announced a proposed rule that, if enacted, will ban employers from entering into non-compete clauses with workers (the “Rule”), and the Rule would void existing non-compete agreements. In their Notice, the FTC stated that if the Rule were to go into effect, they estimate the overall earnings of employees in the United States could increase by $250 billion to $296 billion per year. The Rule would also require employers to rescind non-competes that they had already entered into with their workers. For purposes of the Rule, the FTC has defined “worker” to also include any employees, interns, volunteers, and contractors.”