Healthcare Regulatory

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On November 28, 2023, the California Office of Health Care Affordability (“OHCA”) submitted proposed emergency regulations (the “Regulations”) on the reporting of certain transactions involving health care entities for review by the California Office of Administrative Law, the final step in the regulation process. The final Regulations, reflecting changes in response to public comments and those proposed by the Office of Administrative Law, were released on December 18, 2023, and will apply as of January 1, 2024, to covered transactions with a proposed closing date on or after April 1, 2024. Earlier articles covered the draft regulations and revised regulations, which parallels similar reporting regulations in nine other states, including Massachusetts, Washington, and Oregon. New York is proposing similar regulations for adoption in 2024.

This article will comment on the most recent changes to the Regulations and certain practical issues that must be considered in future transactions that will be subject to the reporting regime and cost and market impact reviews (“CMIR”).

Wyoming physicians are sometimes confronted with the awkward and difficult choice of whether to bring a colleague’s potentially unprofessional, unethical, or harmful conduct to light by making a report to a hospital’s peer review committee, or even the Wyoming Board of Medicine in some circumstances. However, physicians are often unsure whether such a report is justified, and whether it is ethically or legally required. Whether a report is justified or ethically required in any particular situation is beyond the scope of this article–however, we can shed light on whether it is required by Wyoming law.

Provider Relief Fund Update

In the ever-evolving landscape of COVID-19 regulations, Texas has taken a unique stance with Senate Bill 7, which was signed into law by Texas Governor Greg Abbott on November 10, 2023. This legislation specifically addresses COVID-19 vaccination mandates in the private sector, introducing a series of measures aimed at protecting employees’ rights while balancing public health concerns.

In July of this year, the California Office of Health Care Affordability (“OHCA”) released draft regulations requiring the advance reporting of certain healthcare transactions that could affect the cost of healthcare or adversely impact the healthcare market in California. These reporting requirements implement provisions of amendments to the California Health and Safety Code enacted in 2022, which authorized OHCA to review proposed transactions and, if appropriate, undertake a detailed cost and market impact review (“CMIR”) to determine the potential impact on the health care economy of California.

On July 31, 2023, the California Office of Health Care Affordability (“OHCA”) released draft regulations concerning pre-transaction review of so-called “Material Change Transactions” as part of its legislative mandate to review transactions which could have potential impacts on the costs of health care in the State of California.  When approved, final regulations would be effective January 1, 2024. The draft regulations contemplate a dramatic expansion of state review of transactions affecting health care services.  The draft regulations are to be discussed at a public regulatory workshop to be convened by OHCA on August 15, 2023, at its Sacramento offices. OHCA will accept public comments on the draft regulations through August 31, 2023, submitted to CMIR@HCAI.CA.GOV.

Contract management has quickly and importantly developed into an area of focus for in-house counsel and business stakeholders. Effective contract management systems can increase internal accountability and decrease wait times and costs. Further, increased ownership and investment in the maintenance of contractual obligations allows for companies to better track data, including dollars spent, time spent, and results to report to key stakeholders. Given the benefits of effective contract management programs, it is unsurprising that leaders look to develop and implement their own contract management system.

Last month, The Economist published a call to action titled, “There is a worrying amount of fraud in medical research: And a worrying unwillingness to do anything about it.”[1] The article is the latest in a sequence of alarms that some clinical researchers might not be as squeaky clean as we would hope them to be. Senior DOJ officials have in turn emphasized in public remarks that investigating clinical research shortcomings is now a Justice Department priority, with the whistleblower bar following suit.

In the wake of a record number of Covid-19 cases and with flu season around the corner, Governor Tony Evers and Wisconsin Department of Health Secretary Designee Andrea Palm issued a new emergency order on October 1, 2020. Emergency Order #2 is designed to help address an anticipated surge in healthcare staffing needs.

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The hospice industry expressed collective disappointment when the Centers for Medicare & Medicaid Services declined additional time for implementing new election statement and addendum requirements. On October 1, 2020, hospices will need updated forms, processes and training to address new payment conditions. In this episode, Meg Pekarske and Andrew Brenton review the new rule’s key…

In a Policy Statement released on April 3, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced that it will exercise its enforcement discretion and not impose administrative sanctions under the federal Anti-Kickback Statute (AKS) for certain financial arrangements related to COVID-19 covered by the blanket waivers issued by the Secretary of HHS on March 30, 2020 (the Blanket Waivers). The Blanket Waivers apply to sanctions for potential violations of the federal Physician Self-Referral Law (also known as the Stark Law) with respect to specific “COVID-19 Purposes,” which Husch Blackwell summarized in a recent blog. The OIG’s Policy became effective upon release (while the Blanket Waivers are retroactively effective March 1, 2020), and will terminate upon termination of the Blanket Waivers, unless otherwise specified by the OIG.