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Compliance Trends-The Changing Regulatory Landscape for Opioids

April 1, 2021
April 1, 2021

Healthcare is spending a lot of time thinking about ways to strengthen the regulation of opioids. A team of content experts from HCCS, A HealthStream Company, recently attended the Health Care Compliance Association’s 2018 Enforcement Conference, where some sessions focused on measures to combat the opioid crisis.

Navigating the Changing Regulatory Landscape—Opioids

While the False Claims Act and cybersecurity are hot topics in healthcare compliance, the opioid crisis is seen as a national emergency. Nearly all the sessions presented at the conference contained some reference to the opioid crisis and its toll in the areas of addiction, loss of life – accidental overdose - and financial consequences. This presentation focused on recent enforcement actions, a physician’s perspective on opioids and legislative changes.

A Public Health Emergency

The HHS Secretary has declared a public health emergency in response to increased use and abuse of prescription opioids. Professional licensing boards, federal agencies, local law enforcement and multiple provider types are on the front lines of this serious epidemic. Investigative and enforcement actions are originating from a variety of sources under these agencies including the Opioid Fraud and Abuse Unit, Prescription Interdiction and Litigation (PIL) Task Force and data analytics.

Interesting statistics were presented as follows:

  • In the past 2 decades, sales of prescription opioids have increased 4 times.
  • Opioid-related deaths have increased 2 times in that same period.
  • Drug overdoses are the leading cause of accidental death.
  • 75% of heroin users began abusing drugs through prescription opioids.

Increasing Volume of Legal Settlements

There have been numerous settlement actions in the past two years ranging from $28,000 to $2 billion against healthcare organizations, providers and pharmacies. States attorneys general are also heavily involved in lawsuit activities including criminal prosecutions and actions by family members.

More Monitoring, More Scrutiny, More Prescription Oversight

In addition, many state legislatures are requiring providers to utilize the Prescription Drug Monitoring Programs (PDMPs) to monitor patients’ previous prescription drug use before prescribing opioids. State licensing boards are using the PDMP as part of licensure renewal by monitoring prescribers’ patterns and some states are releasing data on a providers prescribing practices to an organization’s chief medical officer or director.

Providers’ (physicians, non-physician providers, and dentists, etc.) prescribing behavior is under close scrutiny. Many providers are voluntarily surrendering their DEA numbers to avoid being subject to the increased risks of prescribing opioids. Providers are required to complete mandatory training on opioid prescribing in several states, and this number may increase.

Additional Layers of Provider Requirements for Prescribing

Alternative therapies, establishing goals for treating a patient’s pain and function, recognizing drug-seeking behavior and noting inconsistencies in patient’s symptoms are just a few of the items that providers must become aware of when providing patient care. Providers are now required to education patients on the risk of additional and overdose, as well as educate patients about other forms of pain management. These additional layers of administrative and treatment requirements are concerning to many physicians. Physicians, non-physician providers and all organizations will need to stay up-to-date on the opioid legislative actions in their respective states. There is concern that the amount of legislative and regulatory action may hamper medical decision-making.