Policy & Compliance

Expert Analysis

• CMS' New 'Breakthrough' Device Policy Shows Little Promise

  

  The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.

• A Preview Of AI Priorities Under The Next President

  

  For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.

• Managing Community Health Needs Assessments: A Checklist

  Excerpt from Practical Guidance

  

  To guide nonprofit hospitals and health systems through their required community health needs assessment every three years, this checklist outlines the steps for 12 phases of the process.

• Pa. Health Employers Must Prep For Noncompete Restrictions

  

  Newly enacted legislation in Pennsylvania prohibits certain noncompete covenants for healthcare practitioners in the state beginning next year, creating compliance challenges that both employers and employees should be aware of, say attorneys at Buchanan Ingersoll.

• FTC Focus: What Access To Patent Settlements Would Mean

  

  Settling parties should adopt a series of practice tips, including specifying rationales to support specific terms, as the Federal Trade Commission seeks to expand its access to settlements before the Patent Trial and Appeal Board, say Shannon McGowan and David Munkittrick at Proskauer.

• Agencies Should Reward Corporate Cyber Victim Cooperation

  

  The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.

• Strategies To Defend Against Healthcare Nuclear Verdicts

  

  The healthcare industry is increasingly the target of megaclaims, particularly those alleging medical malpractice, but attorneys representing providers can use a few tools to push back on flimsy litigation and reduce the likelihood of a nuclear verdict, says LaMar Jost at Wheeler Trigg.

• What Drug Cos. Must Know About NY Price Transparency Law

  

  Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.

• Whistleblowers Must Note 5 Key Differences Of DOJ Program

  

  The U.S. Department of Justice’s recently unveiled whistleblower awards program diverges in key ways from similar programs at other agencies, and individuals must weigh these differences and look first to programs with stronger, proven protections before blowing the whistle, say Stephen Kohn and Geoff Schweller at Kohn Kohn.

• The Licensure Landscape For Psychedelics Manufacturers

  

  As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.

• OSHA Workplace Violence Citation Highlights Mitigation Steps

  

  The Occupational Safety and Health Administration's recent citation against behavioral health company Circles of Care sheds light on the enforcement risks companies may face for failing to prevent workplace violence, and is a reminder of the concrete steps that can help improve workplace safety, say attorneys at Benesch.

• When Banks Unknowingly Become HIPAA Biz Associates

  

  There appears to be significant confusion regarding the application of the Health Insurance Portability and Accountability Act to financial institutions when serving healthcare-related clients, so these institutions should consider undertaking several steps as a starting point in the effort to achieve compliance, say attorneys at Vorys.

• The Regulatory Headwinds Facing Lab-Developed Tests

  

  Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.