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OIG Recommends Measures for Curbing Opioid Misuse and Fraud

January 25, 2018:

Office of Inspector General testimony before the House Committee on Ways and Means in January specified how the OIG is addressing the opioid crisis and its effects on federal health care programs. Gary Cantrell, deputy inspector general for investigations at OIG, detailed what the agency is targeting and its recommendations for further action.

The testimony comes six months after the OIG and its Medicare Strike Force partners’ 2017 National Health Care Fraud Takedown, which netted more than 120 defendants charged with prescribing and distributing opioids and other narcotics. The action also led to 295 opioid-related exclusions.

In particular, OIG seeks to address:

  • Inappropriate opioid prescriptions
  • Inadequate access to treatment for opioid-use disorder
  • Misuse of grant funds, such as the $1 billion awarded in December 2016 by the 21st Century Cures Act to states for opioid abuse treatment and prevention
  • Fraud among providers treating opioid use disorders
  • Diversion of prescription opioids and potentiator drugs

Cantrell pointed out that more than 30,000—out of 50,000—drug overdoses resulting in death in the United States in 2015 involved opioids. According to the Centers for Disease Control and Prevention, almost half of those 30,000 involved prescription opioids. Cantrell highlighted prescription drug diversion as a key contributor to these overdoses.

As far as federal health care programs go, one in three Medicare Part D beneficiaries, or 14.4 million people, were prescribed opioids in 2016. Of those, half a million received high amounts of opioids, defined as an average daily morphine-equivalent dose (MED) greater than 120 mg (equal to 12 tablets of Vicodin or 16 tablets of Percocet) for at least 3 months; the analysis excludes those with cancer or in hospice.

OIG identified 90,000 beneficiaries at “serious risk” of misusing or overdosing on opioids. These beneficiaries were either receiving high doses of opioids or they appeared to be doctor shopping. Nearly 70,000 beneficiaries had an average daily MED of more than 240 mg for the entire year of 2016. More than 20,000 not only had high amounts of opioids, but they also had four or more prescribers and four or more pharmacies filling their prescriptions. Even if these beneficiaries were not doctor shopping, the risk of uncoordinated care still raises red flags.

On the provider side, 400 prescribers had questionable billing patterns; that is, they ordered opioids for the greatest number of beneficiaries at serious risk. These 400 prescribers, 133 of whom were nurse practitioners and physician assistants, wrote more than 250,000 opioid prescriptions for serious-risk patients, totaling a Part D payout of $66.5 million. OIG notes that although some of these patients may legitimately need the medications in large amounts, the billing patterns suggest that prescribers are not checking state databases that monitor prescription drugs, they are prescribing unnecessary drugs that can be resold or used recreationally or operating pill mills (prescribing controlled substances for no medical purpose outside the scope of professional practice), or prescribers’ identification may have been stolen.

The penalties for fraudulently prescribing opioids can be severe. In one of the cases Cantrell outlined in his testimony, a physician found to have operated a pill mill out of his medical offices was sentenced to 30 years in prison and ordered to pay $5.3 million in restitution.

What’s Next

Cantrell testified that OIG is expanding its opioid audits and evaluations. It is also developing a toolkit insurers and enforcement staff can use to identify patients at risk of opioid misuse. This toolkit is scheduled to be released in 2018.

OIG made the following recommendations to the Centers for Medicare and Medicaid Services (CMS) to ensure appropriate use and prescribing of opioids:

  • Restrict certain beneficiaries to a limited number of pharmacies or providers (called “beneficiary lock-in authority”).
  • Expand drug utilization review to include drugs susceptible to fraud, waste, and abuse, such as noncontrolled substances like HIV and antipsychotic medications that are used with opioids as potentiators.
  • Require Part D plan sponsors (those who pay claims and monitor billing patterns) to report all potential fraud and abuse detected as well as any corrective actions they take in response.
  • Improve Medicaid data in the Medicaid Statistical Information System (T-MSIS) so that nationwide trends can be spotted more easily.

Provider Resources

Most providers are concerned about the long-term effects of opioid use, including patient addiction, but they also site a lack of appropriate training on how to prescribe opioids to their patients. To address this need, the Centers for Disease Control and Prevention issued “Guideline for Prescribing Opioids for Chronic Pain” in March 2016 with recommendations for providers treating pain for adult patients outside end-of-life, palliative, and cancer care. This resource is available online (https://www.cdc.gov/drugoverdose/prescribing/resources.html) and offers providers tools such as a checklist for prescribing opioids, a list of nonopioid alternatives for treating pain, suggestions on how to taper opioid dosages, an app that calculates opioid dosages, and guidance on using state prescription drug monitoring programs (PDMPs) to ascertain whether patients are being prescribed medications by other providers.

Providers are encouraged to use these resources to help guide them on ways to safely and effectively prescribe opioids. Providers’ offices should implement written protocols for prescribing opioids—for example, when considering long-term opioid therapy or reassessing therapy on a return visit, the provider or other qualified individual should automatically check the PDMP database.

Below is the CDC’s checklist for prescribing opioids long-term (more than 3 months) for adults older than 18 with chronic pain, excluding those receiving cancer, palliative, or end-of-life care.

When CONSIDERING long-term opioid therapy:

  • Set realistic goals for pain and function based on diagnosis (eg, walk around the block).
  • Check that non-opioid therapies tried and optimized.
  • Discuss benefits and risks (eg, addiction, overdose) with patient.
  • Evaluate risk of harm or misuse.
    • Discuss risk factors with patient.
    • Check prescription drug monitoring program (PDMP) data.
    • Check urine drug screen.
  • Set criteria for stopping or continuing opioids.
  • Assess baseline pain and function (eg, PEG scale).
  • Schedule initial reassessment within 1– 4 weeks.
  • Prescribe short-acting opioids using lowest dosage on product labeling; match duration to scheduled reassessment.

If RENEWING without patient visit:

  • Check that return visit is scheduled = 3 months from last visit.

When REASSESSING at return visit:

Continue opioids only after confirming clinically meaningful improvements in pain and function without significant risks or harm.

  • Assess pain and function (eg, PEG); compare results to baseline.
  • Evaluate risk of harm or misuse:
    • Observe patient for signs of over-sedation or overdose risk.
    • If yes: Taper dose
    • Check PDMP.
    • Check for opioid use disorder if indicated (e.g., difficulty controlling use).
    • If yes: Refer for treatment.
  • Check that non-opioid therapies optimized.
  • Determine whether to continue, adjust, taper, or stop opioids.
  • Calculate opioid dosage morphine milligram equivalent (MME).
  • If = 50 MME /day total (= 50 mg hydrocodone; = 33 mg oxycodone),increase frequency of follow-up; consider offering naloxone.
  • Avoid = 90 MME /day total (= 90 mg hydrocodone; = 60 mg oxycodone),or carefully justify; consider specialist referral.
  • Schedule reassessment at regular intervals (= 3 months).

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