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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.


Telehealth Flexibility Updates: HIPAA, DEA, and CMS

The Covid-19 Public Health Emergency (PHE) officially ended on May 11, 2023. But what does that mean for telehealth, a field that expanded exponentially during the PHE? Fortunately, many of the flexibilities will remain intact, at least temporarily. This client alert presents a brief overview of the timelines that providers need to follow, but for a more comprehensive review of telehealth flexibilities and when they will end

WEBINAR SERIES RECAP | Ending the Public Health Emergency + Post-Pandemic Check-Up

Some may take the position that the rest of the country already returned to a new “normal” following the COVID-19 pandemic.  But healthcare providers continue to implement COVID protocols and navigate the ever-changing healthcare regulations at both the federal and state levels.  It is important for healthcare providers to take time for a “Healthcare Check-Up” with the start of 2023 and the ending of the Public Health Emergency (“PHE”).

Sharp Rise in False Claims Act Cases - Navigating the FCA Waters

Recently, on April 18, 2023, the United States Supreme Court heard arguments regarding the FCA’s scienter, or mental state, requirement. To prove violation of the FCA, the statute requires that a defendant “knowingly” file false claims for payment. The term “knowingly” is defined within the statute to mean a person that acts with actual knowledge, deliberate ignorance, or reckless disregard. Circuit courts are split on how to interpret and apply the knowledge element of the FCA, and based on the Supreme Court’s decision, there will be a large impact on healthcare defendants and their businesses as well as anyone who contracts with, or receives money from, a federal program. A broader interpretation of the FCA would unnecessarily target and stifle healthcare, and other businesses, for simple errors in daily operations. This goes against the intended application of the FCA, which was to prevent fraudulent activity.

Areas of Opportunity in Columbus: Highlights from the Columbus Opportunity Summit

On April 27, 2023 Columbus Business First held its annual Columbus Opportunity Summit, bringing together business and economic development leaders to provide an update on how Central Ohio is preparing for expected growth in the coming years, an issue heightened by the arrival of Intel at its 1,000 acre site in Licking County, just outside of Columbus. The site will be home to two new chip factories with room to grow to a total of eight factories and is a $20 Billion investment.

BREAKING: Biden Administration Has Officially Ended the Two Remaining COVID Vaccine Mandates

As of May 1, 2023, the Biden Administration has officially ended the two remaining COVID vaccine mandates: (1) the Federal Contractor Mandate, and (2) the CMS Healthcare Provider Vaccine Mandate.