Why Compliance Should Care About the War on Opioids

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By Margaret C. Scavotto, JD, CHC
President, Management Performance Associates
Scott T. Gima
Executive Vice President and Chief Operating Officer
We have an opioid problem

In the United States, 134 opioid-related deaths occur daily. In 2016, more than 60,000 Americans died from drug overdoses, and two-thirds of those deaths were opioid related. Fentanyl is now responsible for more overdose deaths (28.8%) than heroin. And, three out of four new heroin users first misuse prescription opioids.

In 2017, almost one-third of Medicare Part D beneficiaries received opioids. About 460,000 beneficiaries received high amounts of opioids; 71,000 beneficiaries were at serious risk of misuse or overdose; and almost 300 prescribers had questionable prescribing. Everyone agrees our country has an opioid problem.

Not surprisingly, in 2017, the U.S. Department of Health and Human Services declared the opioid epidemic a public health emergency. In March 2018, the President of the United States announced the Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand, which gave the DOJ more resources to prosecute opioid fraud and abuse. In November 2018, the OIG identified “Reducing inappropriate prescribing and misuse of opioids” as its #1 Management & Performance Challenge.

Our nation’s concern about rising opioid misuse has been met with an increase in opioid-related criminal charges. Here are some common trends in enforcement, with corresponding compliance risks and suggestions for how to respond to them.

OPIOID COMPLIANCE RISK: DIVERSION

Nurse steals opioids from patients. An Illinois nurse who stole opioid patches from terminally ill nursing home residents pleaded guilty to resident burglary. The nurse, who was off-duty at the time of the theft, faces up to 15 years in prison.

Nurse charged with taking a hospice patient’s morphine sulfateA Massachusetts licensed practical nurse (LPN) was charged with drug tampering. The LPN “tampered with three bottles of morphine sulfate prescribed to a hospice patient. In an attempt to avoid detection, she replaced the extracted medication with another liquid,” lowering the potency of the drug to only 4-29%.

While these examples of are individuals facing criminal charges, organizations can also face consequences. For example, Effingham Health System entered a $4.1 million settlement to resolve allegations that it failed to “provide effective controls and procedures to guard against theft and loss of controlled substances, leading to a significant diversion of opioids, and failing to timely report the suspected diversion to” the DEA.

What you can do:
  1. For patients taking pain medication, nurses must document pain relief. Inadequate pain relief could be a sign of narcotic diversion.
  2. Review and enforce all narcotics-related polices. Fairly and objectively investigate and enforce policies.
  3. Make sure end-of-shift narcotic counts are conducted regularly by two nurses.
  4. All narcotic wastage must be witnessed by two nurses.
  5. Monitor narcotic ordering patterns to verify ordering reflects actual medication usage.
  6. Nurses need to confirm placement of narcotic patches every shift. Patches must include application date, time and initials of the nurse who applied the patch.
  7. Train management and staff on signs and symptoms of opioid use as well as withdrawal symptoms.

opioid use symptoms

OPIOID COMPLIANCE RISK: FORGED PRESCRIPTIONS

Unlicensed nurse practitioner indicted for prescribing AdderallA nurse practitioner with a suspended license was indicted for writing prescriptions for Adderall. He faces 20 years in prison and/or a $1,000,000 fine.

What you can do: verify licensure

Verify licensure for all new hires and licensed contractors, including temporary and agency staff. Never rely on documentation provided by employees or contractors – always independently verify. Some software programs will verify licensure status every 24 hours to further minimize your risk.

OPIOID COMPLIANCE RISK: DOCTORS IMPROPERLY PRESCRIBING

Doctors arrested for selling opioidsOne physician was charged with conspiring to unlawfully dispense controlled substances, after he provided more than 1,000 oxycodone prescriptions for no legitimate medical purpose – in exchange for cash. Another physician is accused of recruiting Medicare and Medicaid beneficiaries for oxycodone and oxycontin prescriptions.

Doctor sentenced for fictional office visitsThe doctor billed Medicare for face-to-face office visits for patients who did not visit her office. Instead, patient family members came to the doctor’s office, where they received prescriptions for Schedule II controlled substances such as oxycodone. The doctor also falsified her medical records to make it look like patients had been present for an office visit. The doctor was sentenced to six months in prison, will forfeit her medical license, and will be permanently excluded from Medicare and Medicaid.

Physician assistant paid to prescribeA physician assistant (PA) was convicted for taking kickbacks in exchange for prescribing fentanyl spray. The PA wrote more than 750 prescriptions for the spray – while being paid almost $50,000 by the drug manufacturer to speak at events.

And in April 2019, the OIG announced The Appalachian Prescription Opioid Surge Takedown, the largest opioid takedown in law enforcement history: sixty individuals were charged for illegally prescribing and distributing opioids and other narcotics, or healthcare fraud. Fifty-three medical professionals were charged. The takedown involved 350,000 controlled substance prescriptions and more than 32 million pills.

What you can do: screen your providers

Conduct background checks. Every month, the OIG posts multiple press releases of opioid-related criminal enforcement like the examples cited above. Examples like these should show up on a criminal background check. Make sure criminal background checks are conducted prior to hiring – without fail—and implement an audit process to verify that background checks are completed with 100% accuracy.

Find your excluded providersEnsure employee screening procedures include monthly excluded provider screens, which identify (among other things) felony and misdemeanor convictions related to controlled substances; and license revocation, suspension or surrender.

The OIG can exclude providers from Federal health care program participation if they are convicted of certain crimes, which include felonies and misdemeanors related to controlled substances connected to the healthcare industry. In the 2018 National Health Care Fraud Takedown, the OIG excluded 587 individuals based on opioid diversion and abuse. Conducting these monthly screens is expected by the OIG, and will help you identify individuals with prior criminal activity related to controlled substances as soon as possible.

For example, the OIG used this authority to exclude Dr. Adam Duer indefinitely after he allegedly prescribed “clearly excessive amounts of controlled substances,” for non-medical and medical purposes. Dr. Duer surrendered his license to California while he was being investigated for unprofessional conduct and gross negligence related to his controlled substance prescribing practices.

The bottom line

Many of your patients will be part of our nation’s opioid problem – and some of your employees might be too. Your compliance program needs to be part of the solution.