December 07, 2017

Policy prescriptions for opioid epidemic confusing, not always effective, experts tell ABA summit

Looking at data projected on a screen showing a steady increase in deaths from opioids culminating in 50,000 in 2016, “It’s a really depressing chart,” acknowledged Daniel Blaney-Koen, senior legislative counsel at the American Medical Association in Chicago. He was a panelist on the program “The Opioid Epidemic: Legal and Policy Considerations, held during the ABA Washington Health Law Summit,  Dec. 4-5 at the Ritz-Carlton in Washington, D.C.

Daniel Blaney-Koen, retired Judge Arthur L Burnett and T. Jeffrey Fitzgerald address the opioid epidemic during the ABA Washington Health Law Summit sponsored by the Health Law Section and Government and Public Sector Lawyers Division.

The same chart showed that starting last year, deaths from heroin and illicit fentanyl started outpacing those from opioids.

The highest number of opioid prescriptions (259 million) came in 2012. Every year since, there has been a decrease in every state, so that the total in 2016 was 215.5 million prescriptions.

Displaying a chart illustrating “massive” regional variation in prescriptions, Blaney-Koen said, “This kind of variation probably doesn’t exist for many types of medical care, but it does for opioid prescribing, and we need to understand why if we’re going to have the policy interventions and the practice interventions to actually make a difference.”

Nearly all those policy interventions have occurred in the past two or three years, and they include:

  • More than 30 states have prescription drug monitoring programs

  • More than 25 states have continuing medical education mandates

  • More than 20 states have opioid-prescribing restrictions

  • There is an increased focus on “doctor shoppers” in search of opioid prescriptions

Blaney-Koen said that when a person is flagged to law enforcement as a “doctor shopper” getting multiple opioid prescriptions, it could be an illicit pill seeker or it could just be someone with uncoordinated care. In any case, the doctor who has prescribed to this person is also flagged to law enforcement and to his/her medical board.

Despite the moves to address the epidemic, Blaney-Koen said states have largely been absent in increasing access to treatment for pain or for substance abuse.

“Unless and until the conditions and the access to treatment both for pain and for substance-use disorders significantly improve, those mortality numbers are going to increase,” he warned.

Attorney T. Jeffrey Fitzgerald of Polsinelli LLP in Denver represents health care providers and said that over the last year about two-thirds of his caseload related to opioid prescriptions. He said it takes time to digest the rapid changes in this area.

There is a wide variation in the new state laws, such as:

  • prescribing restrictions that can run from three to 14 days

  • some have dosage limit requirements

  • varying definitions of what an initial prescription is

Even though the laws regulating opioid prescriptions vary from state to state, Blaney-Koen doesn’t thing having a federal standard is necessarily the best way to go; he doesn’t think it will solve the current patchwork of policies trying to provide health care.

Fitzgerald pointed to his home state of Colorado’s new Medicaid regulations that took effect Oct. 1 as an example:

  • Reduce MME (morphine milligram equivalents) coverage to 250 MME/day, which is a “hard cap,” he said

  • First-time opioid beneficiaries are limited to an initial 7-day supply, then up to 2 refills (Prior to Oct. 1 there was no similar standard and it was left to the discretion of the physician, so this is a “quite specific and particular guideline” and applies a “one-size-fits-all remedy,” he said.)

The new regulations create conflict between the insurance coverage and the physician treatment approach and the speakers asked, who resolves that?

 “One of the most shocking things to me is across the country there is little discussion about what to do with chronic pain [vs. acute pain] patients,” Fitzgerald said.

Blaney-Koen agreed that there is increased stigmatization for those with chronic pain, and that there need to be options for them.

If a doctor wants to treat a patient in pain with non-opioid alternatives, say with physical therapy, acupuncture, yoga, etc., he said, those options are much more expensive than a prescription and might not be covered by insurance.

“This is where public policy needs to align with health care” and is one aspect of what needs to change, Blaney-Koen said.

In addition, when pain clinics shut down, what happens to the likely several hundred patients’ continuity of care? “That’s the conversation that isn’t being had,” he said.

“The stigmatization of pain is real, and patients in pain deserve the same level of compassion and comprehensive care as any other patient,” Blaney-Koen said.

Said Fitzgerald: “Treatment and access for those with a substance-use disorder must drastically increase. We know treatment works.”

Retired judge Arthur L. Burnett Sr., national executive director and vice president of administration at National African American Drug Policy Coalition, Inc. in Washington, D.C., suggested looking at the treatment military veterans are getting for PTSD and amputations, which might offer a gold standard for everyone.

Fitzgerald turned to the law enforcement aspect of the epidemic, saying they are watching:

  • Prescribing (the controlled substance must be for a “legitimate medical purpose” and “not outside the usual course of professional practice”)

  • Reporting (mandatory reporting to the DEA within one day of drug theft or significant loss)

  • Monitoring (DEA registrant must have “effective controls” in place to prevent diversion and theft).

Also playing a role in enforcement are:

  • Department of Justice – criminal and civil prosecution

  • Drug Enforcement Agency – can revoke prescription authority (for a physician, “that’s almost a death blow to your practice,” Fitzgerald said.)

  • State medical license boards, which have become more active in these issues in the last few years

  • Plaintiff’s bar – can bring medical malpractice suit for overprescribing

Fitzgerald then outlined ways doctors can reduce their legal risk:

  • Develop a written policy on how the practice treats chronic pain, using national and/or state guidelines to customize to the practice, since the standard will be different for an orthopedic practice vs. a rural family clinic

    • It should be concise, practical and readable

    • It should show significant discretion on standards
  • Do a risk assessment on the patient population and run a list of prescriptions to look for patterns

    • Identify high-risk patients

    • Analyze for potential diversion

    • Analyze for clinical care and documentation quality (ask “Do we have a hard cap that we won’t go above?” “Should we reduce our risk?” Doing this will help with compliance, he said.)

Blaney-Koen concurred, advising to start with the data and identify and analyze the outliers.

  • Have a clear process to document the basis for high-dose prescriptions

    • Automate “doing the right thing”

    • The process should ease the burden on providers

    • The process can add significant risk reductions
  • Consider additional processes to keep up with clinical and regulatory changes

  • Stay current with relevant continuing medical education or prescribing refresher courses

The speakers agreed that the solution isn’t to stop writing opioid prescriptions, because those people are still in pain will go elsewhere, and  “under-prescribing will have collateral consequences,” Fitzgerald said. He said he would prefer that doctors continue to prescribe what they believe is correct than to under prescribe.

The speakers advocated for more education for doctors on the ongoing changes in this area, and Blaney-Koen pointed to, an AMA microsite with resources for doctors and a breakdown of state regulations.

The summit was sponsored by the Health Law Section and co-sponsored by the Government and Public Sector Lawyers Division.