On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable by Medicare. Although the majority of telehealth waivers enacted during the COVID-19 public health emergency (the “PHE”) are set to expire at the end of 2024 in the absence of legislative action, CMS has proposed to leave certain key flexibilities in place, including the allowance for physicians and other practitioners to furnish remote “direct supervision” through their immediate availability via audio-video technology.
Continue Reading Key Telehealth Updates in the CY 2025 Physician Fee Schedule Proposed Rule

The U.S. has long had a shortage of physicians in various practice areas. The shortage is even more pronounced in rural areas. International medical graduates (IMG’s) who come to the U.S. to complete a residency in a specialty area primarily come to the U.S. on J-1 visas. By statute, any physician who enters the U.S. on a J-1 must return home for 2 years before applying for H-1B status or permanent residency.
Continue Reading Having Trouble Recruiting Physicians? The Conrad 30 Window is Opening Soon

In an era where artificial intelligence (AI) is reshaping landscapes in the healthcare industry and beyond, understanding the governance of AI technologies is paramount for organizations seeking to utilize AI systems and tools. AI governance encompasses the policies, practices, and frameworks that guide the responsible development, deployment, and operation of AI systems and tools within an organization. By adhering to established governance principles and frameworks, organizations can ensure their AI initiatives align with ethical standards and applicable law, respect human rights, and contribute positively to society. Various international organizations have set forth AI governance principles that provide organizations with a…
Continue Reading Navigating the Complex Landscape of AI Governance: Principles and Frameworks for Responsible Innovation

California’s Office of Health Care Affordability (OHCA) has officially approved amendments (“Amendments”) to the cost and market impact review (CMIR) regulations, effective August 22, 2024. Most significantly, these Amendments expand the scope of health care entities (HCEs) subject to a CMIR, among other notable changes discussed below.
Continue Reading Update: OHCA Approves Amendments to Cost and Market Impact Review (CMIR) Regulations

On August 21, 2024, Sheppard Mullin’s Healthy AI team conducted a CLE webinar on what hospitals, health systems and provider organizations should consider in building an artificial intelligence (“AI”) governance program. As they discussed, key elements of an AI governance program include: (1) an AI governance committee, (2) AI policies and procedures, (3) AI training, and (4) AI auditing and monitoring. These components of an AI governance program will help healthcare organizations embrace the complexities of AI use in healthcare by establishing appropriate guardrails and systematic practices to encourage its safe, ethical, and effective use. This post reviews each of the…
Continue Reading Key Elements of an AI Governance Program in Healthcare

An April 2024 independent[1] report (“Report”) analyzed the results of the first four years following implementation of the Maryland Total Cost of Care Model (the “TCOC Model”), finding that between 2019 and 2022 (the “TCOC Measuring Period”), the TCOC Model reduced Medicare spending, hospital admissions, and health disparities. CMS also distributed a summary of the Report’s findings.
Continue Reading Attention Maryland Providers: Are You Availing Yourselves of Regulatory Flexibilities under the TCOC Model?

As artificial intelligence (AI) continues to transform the healthcare industry, hospitals, health systems, and provider organizations are increasingly recognizing the need for effective AI governance. But what exactly is AI governance, and why is it so crucial for healthcare organizations?
Continue Reading Building a Robust AI Governance Program in Healthcare

The IRS is underway with conducting audits of 35 Section 501(c)(3) tax-exempt hospitals, with a particular focus on “community benefit,” as the IRS announced in June 2024. Targeted hospitals appear to be those who reported low community benefit percentages on their IRS Form 990.
Continue Reading IRS Audits & Ongoing Scrutiny of Nonprofit Hospitals – Key Background & Action Steps

With technology rapidly evolving and jurisdictions appearing blurred, it is increasingly important to be mindful of data flow and use. This is particularly true where patient data is being accessed by offshore subcontractors.
Continue Reading Do You Catch Our Drift? Navigating the Waters of Offshoring and Patient Data

On August 2, 2024, the United States Fifth Circuit affirmed the rulings in the No Surprises Act litigation brought by the Texas Medical Association and other plaintiffs[1] challenging the August 2022 Final Rule that has been issued by the Departments of Labor, Treasury, and Health and Human Services (the “Departments”) that applied to the Independent Dispute Resolution (“IDR”) process created by the No Surprises Act (the “Act”).[2]…
Continue Reading No Surprises Here – Providers Win Again in No Surprises Act TMA II Litigation Vacating Independent Dispute Resolution Rule

On July 18, 2024, the Massachusetts Senate passed S. 2871, An Act Enhancing the Health Care Market Review Process (the Bill), to increase oversight of healthcare transactions involving private equity firms, real estate investment trusts, and management services organizations (MSOs). The Bill is another example of the increasing trend towards curbing private equity influence in health care, as highlighted in our previous blog series on California’s Assembly Bill 3129.[1] In Massachusetts, 51% of all healthcare provider transactions in the past decade have involved private equity firms,[2] and the Bill targets such involvement with the goals of expanding…
Continue Reading Massachusetts Senate Passes Bill to Increase Oversight of Private Equity Healthcare Transactions

On July 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (“Proposed Rule”) in which it outlined proposed amendments to the suspension provisions and deadlines for reporting and returning Medicare Part A and Part B overpayments, and stated that it is continuing its review and evaluation of previously proposed changes to existing overpayment regulations.
Continue Reading CMS Proposes to Amend Overpayment Rule-Questions Remain Regarding How the Rule Will be Implemented Should CMS Adopt the False Claims Act’s “Reckless Disregard or Deliberate Ignorance” Standard

On June 27, 2024, the U.S. Supreme Court dismissed Idaho v. United States on procedural grounds and sent the case back to the Ninth Circuit. By doing so, the Supreme Court reinstated the preliminary injunction issued by the district court and temporarily allows abortions to be performed when necessary to preserve the health of the pregnant woman. Mike Moyle, et al., v. United States, No. 23-726, and Idaho v. United States, No. 23-727. However, by failing to rule on the merits of the case and the core question of whether the Emergency Medical Treatment and Labor Act (EMTALA)…
Continue Reading SCOTUS Punts on EMTALA Preemption Question