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Health care industry take note: Current enforcement trends

| Nov 7, 2018 | Stark Law/Anti-Kickback Statutes |

The health care industry is heavily regulated. Various laws and court cases impact the practices of drug manufacturers, physicians, nursing homes and others in the medical field. Those that are part of this field are wise to stay abreast of changes that could impact their profession.

Three specific enforcement trends noticed in recent months include:

  • Review the merit of cases. Earlier this year, the DOJ released a memo encouraging prosecutors to avoid meritless Federal False Claims Act (FCA) cases. The memorandum provided a list of factors for prosecutors to consider when determining if the DOJ should pursue the case, or seek dismissal. This memo could shift things within the DOJ and help stymie the recent increase in qui tam cases.
  • State and feds continue to focus on opioid crisis. The DOJ continues its crackdown on those who violate the law and aid the current opioid crisis. The $150 million minimum settlement between Subsys and the government a prime example. The agency has pursued cases against large, corporate drug manufacturers as well as individual physicians that were accused of prescribing pain medications without medical necessity.
  • Stark Law and value-based care. Calls to change the strict rules of the Stark Law continue. One motivating push for change is the fact that providers are moving towards a value-based care model of health care. This law has repeatedly served as an obstacle, resulting in the wrongful prosecution of medical professionals attempting to implement this change. The United States Department of Health and Human Services (HHS) has stated it would “sprint” to coordinated care to help address these regulatory issues and further “the government’s interest in paying for quality over quantity” when it comes to medical care services.

These enforcement trends could result in serious changes to health care law. As such, it is wise to keep up to date with these trends and any resulting changes and adjust your practice accordingly.

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