The Miles & Stockbridge Health Care Practice Group hosted its inaugural Hot Topics in Health Care Law seminar last month for clients from Maryland and beyond. Miles & Stockbridge health care lawyers kicked off the seminar with a year in review, which covered topics including recent appellate cases and legislation impacting health care, consolidation in the health care market, the current state of Medicare telehealth rules, website tracking technologies and HIPAA breaches and enforcement.

The seminar finished with an engaging panel discussion, with four leaders in the health industry speaking about challenges and opportunities facing the health care community in 2024. Panelists Tom Kleinhanzl, president and CEO of Frederick Health and the current chair of the Maryland Hospital Association’s Board of Trustees; Jeanette Cross, managing director at Berkeley Research Group and a go-to consultant on Maryland hospital rate reimbursement; Clorinda Walley, president of Good Days, a national charitable patient assistance organization helping patients with chronic illness; and Cliff Nelson, CEO of PsychoGeriatric Services, a large behavioral health practice, illustrated how tackling the very hard issues in health care — such as how to provide equitable access to quality care in a cost-effective yet fiscally responsible manner — will require collaboration with like-minded partners from different spheres of the health care industry.

Year in Review

Chris Dean kicked off the 2023 Year in Review by examining Maryland appellate decisions impacting health care. Chris discussed various cases, including In re Sulerzyski, Baltimore Cotton Duck, LLC v. Ins. Comm’r of Maryland, and Romeka v. RadAmerica II, LLC. There were many takeaways from these cases, including that Maryland state courts remain a good forum for Medicaid disputes, health insurance co-ops created under the Affordable Care Act of 2010 were largely unsuccessful, especially outside of rural areas, and when it comes to whistleblower actions, the timeline matters.

Chris also discussed Maryland legislation from 2023 impacting health care, including the increase to the 9-8-8 behavioral health hotline trust fund, the Maryland Department of Health’s application for Substance Abuse and Mental Health Services Administration (SAMHSA) grant funding for a SAMHSA demonstration project and the establishment of a behavioral health value-based purchasing pilot program.

Chris ended his portion by giving an update on various programs within the Centers for Medicare and Medicaid Services (CMS) Innovation Center (also known as CMMI).

Leslie Cumber next presented on consolidation in the health care market and the government’s response, including the new merger guidelines released in December by the Department of Justice and the Federal Trade Commission. The guidelines identify the procedures and enforcement practices that the government uses when investigating a transaction and whether that transaction violates the antitrust laws. Importantly, the new guidelines lower the threshold used to evaluate whether a transaction triggers a rebuttable presumption that it may substantially lessen competition or create a monopoly. Additionally, the new guidelines seem to rely on legal theories that are less proven, such as finding that a firm may violate various antitrust laws if it engages in an anticompetitive pattern of multiple small acquisitions, regardless of whether any individual acquisition would violate the antitrust laws.

Leslie also gave an overview of the Medicare telehealth flexibilities that have been extended beyond the public health emergency. For example, CMS extended the relaxation of the Medicare telehealth originating site rules through the end of this year. This means that providers can continue to be reimbursed for telehealth services provided to Medicare beneficiaries who are at home through Dec. 31. Similarly, providers can continue to prescribe controlled substances to new patients through telehealth through the end of this year.

Finally, Celia Van Lenten covered updates coming out of the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR). According to OCR guidance, when a website analytics vendor deploys tracking technology, such as pixels or cookies, on a health care provider’s website and has access to identifying information about website users, such as IP address, that information is protected health information (PHI), and the disclosure of PHI to the vendor is subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). OCR has taken a very expansive view of the meaning of PHI in this context, which has spurred health care providers to assess and, in many cases, modify their use of website tracking technologies. OCR’s guidance is currently being challenged in federal litigation.

Celia also gave an overview of recent OCR HIPAA enforcement actions. Most allegations of noncompliance centered around violations of the HIPAA Security Rule and not having the foundational elements of an up-to-date, enterprise-wide HIPAA security risk analysis and risk management plan, which is an area that many health care companies could improve upon. Celia wrapped up her remarks by reporting that HIPAA breaches reached record highs in 2023, with 733 reports of “large” breaches impacting over 134 million individuals.

The Panel

The panel discussion, moderated by Molly Ferraioli and Lisa Keenan, was a lively exchange on the challenges and opportunities facing the health care industry.

Even though the panelists represent various sectors of the health care market, they were aligned in many of their top challenges from the past year, particularly as it relates to the labor shortage and the economic strain caused by hiring, training and retaining a workforce.

Jeanette Cross and Tom Kleinhanzl discussed the strengths and weaknesses of Maryland’s current Total Cost of Care Model in addressing the challenges hospitals have been facing, including in light of CMMI’s new total cost of care model, known as the “Advancing All-Payer Health Equity Approaches and Development” (AHEAD) model. This discussion was particularly timely, as the Maryland Department of Health and the Health Services Cost Review Commission are currently evaluating whether to apply to participate in the AHEAD model. A key component of the AHEAD model will be an even stronger commitment to health equity to reduce health disparities and improve population health.

Among her many insightful comments, Clorinda Walley discussed efforts at the federal level to lower the cost of prescription drugs for Medicare beneficiaries, although she argued that the law does not go far enough to tackle the systemic problem of rising prescription drug prices. Cliff Nelson spoke earnestly about the economic challenges facing the behavioral health space, including those arising out of increasing provider costs, and how indexing Medicare reimbursement to inflation could solve at least some of those challenges.

For more information and access to presentation materials, please visit the event site.

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