Government officials and health law experts will address a variety of emerging health industry topics during the American Bar Association Washington Health Law Summit on Dec. 11-12 in Washington, D.C.
On Monday, Dec. 11, Melanie Fontes Rainer, director of the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) in Washington, D.C., will deliver the keynote address on the priorities OCR is tackling through rulemaking and enforcement, including reproductive health care, LGBTQ issues and cybersecurity. She will also discuss various federal civil rights protections and HIPAA authorities.
Program highlights include:
• “Supreme Court Review” — A panel of experts will discuss health law cases decided in the 2022-23 Supreme Court term, including Health and Hospital Corp. of Marion County v. Talevski, United States ex rel Schutte v. SuperValu, Inc., Polansky v. Executive Health Resources and Dubin v. United States.
• “Health Care Antitrust Legal Implications: Consolidation/Cross Market Mergers” — Two experts will examine the Biden administration’s efforts to address anti-competitive health care consolidation and key implications. Nalini Pande, managing director of Sappho Health Strategies LLC, in Arlington, Virginia, will provide the policy perspective, highlighting how we got to this point (including some of the unintended consequences of integrated business models and value-based care) and current and new mechanisms for state transactional oversight. Rohan Pai of the Federal Trade Commission in Washington, D.C., will share the government’s legal perspective, FTC guidelines, current law and future outlook.
• “Psychedelics: Clearing the New Frontier in Mental Health Therapy” — Psychedelics show promise in treating anxiety, ADHD, PTSD, depression and opioid and alcohol addiction. However, data are still limited and the DEA classification of psychedelics impedes further research. Psychedelics (psilocybin, LSD and MDMA) are Schedule 1 drugs that have “no currently accepted medical use.” This classification creates obstacles to researching their safety and efficacy as therapeutics. It also limits funding and encourages states to enact their own laws, creating inconsistency. This expert panel will explore the research to date, permitted uses and potential policy solutions.
• “Town Hall Breakfast with Leaders from the OIG Office of Counsel to the Inspector General” — This will be a discussion among Robert DeConti and Lisa Re, both assistant inspectors general for legal affairs; Susan Edwards, chief, Industry Guidance Branch; and Susan Gillin, chief, Administrative and Civil Remedies Branch, all of Washington, D.C.
• “PBMs and Hospitals Under Attack: Significant Federal and State Legislative and Regulatory Changes on the Horizon” — Pharmacy Benefit Managers (PBMs) and hospitals have been under increased scrutiny from policymakers in state capitols and Washington for their role in rising health care costs and the perceived lack of transparency. A panel of experts will discuss federal and state regulatory and legislative proposals related to the hospital and PBM industry sectors and the significant impact these proposals could have on the marketplace, including enhanced price transparency, government price controls, limitations on rebates, site-neutral payments and negotiation of prices at CMS. They will also address increasing regulation at the state level post recent SCOTUS rulings.
• “AI in Health Care: Parting the Mist to Get to Reality” — This panel will provide a broad overview of the myriad uses for artificial intelligence in health care, including how AI can affect the health care industry moving forward, what AI means exactly and how regulations will treat it. Privacy, security, practice of medicine, fraud and abuse, prescribing, FDA oversight and more are among the issues to be reconciled. A case study will be used to evaluate the legal, policy and ethical concerns when using AI in health care.
• “DOJ Health Care Fraud Enforcement Priorities and Recent Developments” — This panel of experts, including DOJ’s Jacob Foster, principal assistant chief of the Criminal Division, Fraud Section, and Andy Mao, deputy director of the Criminal Division, Fraud Section and coordinator of the Elder Justice Initiative, will discuss DOJ’s recent civil and criminal enforcement priorities and notable recent developments in its efforts to combat health care fraud. They will also discuss DOJ’s use of data analytics to identify and investigate health care fraud schemes.
For additional information on the summit, visit www.americanbar.org/groups/health_law.
