By Ronald Chapman II

The Impact of the 2016 CDC Guidelines

For the last six years state regulators, federal prosecutors, insurers and other stakeholders in the healthcare space have propped up the 2016 Guideline for Prescribing Opioids as a new standard of care for opioid prescribing. Paid government expert witnesses have clambered to witness stands across the country to exalt the guidelines as a new de-facto standard of care and to heavily criticize doctors in failing to rigidly apply dosage thresholds, risk assessments, urine drug screen monitoring policies and the like. The impact was widespread, creating a wave of “pain refugees” - legitimate pain patients cast aside by doctors who were unwilling (or unable) to accept the risk of federal prosecution needed to maintain proper pain management of their patient population.

Defense attorneys representing physicians in opioid prescribing prosecutions were left to wrangle a new federal standard for prescribing opioids as prosecutors were quick to misapply the guidelines to gain an edge in heavy handed criminal prosecutions against physicians whose only crime was compassion for their patients and an unwillingness to cede to the CDC’s take on the sacred practice of medicine.

After a wave of popular support brought about by physician advocacy groups such as “Don’t Punish Pain” and “Doctors of Courage”, as well as widely publicized rebukes by even the AMA - the guidelines began to buckle under their own weight. On the heals of a new public health emergency brought about by the widespread dismantling of the physician patient relationship in opioid prescribing- the CDC finally decided to correct course.

Changes in the 2022 Opioid Prescribing Proposed Guidelines

And now, six years later - the CDC “Clinical Practice Guideline for Prescribing Opioids” are changing.

The only question is whether the CDC will claw back the dangerous guidelines of the past that have subjected prescribers to unnecessary scrutiny, unwarranted criminal prosecution, and confusion surrounding their duty to treat patients. The proposed guideline was posted for public comment recently and the American Medical Association released its comment on April 11, 2022 with a firm statement to the CDC - “you didn’t go far enough”. Physicians subjected to federal scrutiny through criminal prosecution, DEA sanction, or civil monetary penalty action may find refuge in the newly proposed guidelines and the AMA’s harsh rebuke of the previously adopted 2016 CDC Guidelines. But more can be done.

The new proposed guideline makes three critical changes intended to un-ring the bell that so deeply impacted the United States pain population. First, the proposed guidelines do away with the 2016 recommended dosage and day limits for appropriate prescribing. Second, the newly proposed guideline emphasizes patient-physician shared decision-making instead of the rigid application of standards called for in the prior guideline that turned physicians into detectives instead of caregivers. Third, the CDC acknowledged that the prior guidelines were widely misapplied and incorporated into state regulations, PBM audits, insurance policies, federal prosecutions, and DEA administrative hearings.

The AMA’s Reaction

Many will see the newly proposed CDC guidelines as a step in the right direction. But the AMA wants the CDC to go one step further and demands that the CDC to urge “all relevant state, national and federal stakeholders, including legislatures, regulators, health plans, pharmacy chains, and pharmacy benefit companies to remove all vestiges of inflexible numeric thresholds based on the 2016 Guideline”. The AMA also urges the CDC to “undertake a national marketing and communications campaign to make clear to the general public, law enforcement, and all health care professionals that the final CDC 2022 Guideline should not be a replacement for clinical judgment or individualized, person-centered care.”

In the words of the AMA - “this would help restore the balance in pain care to show that opioid therapy is a legitimate form of treatment”.

The AMA also believes that the CDC needs to go further in order to help remove the stigma of opioid therapy for all patients. The AMA recognized that the 2016 Guidelines created widespread stigma of pain patients. Pharmacies abruptly cut off patients receiving opiates if their dosage was deemed too high, providers did the same when there was any sign of aberrant behavior, and diagnostic tools such as urine drug tests became a deciding factor in whether a patient would receive care. The AMA wants that stigma to end immediately because it recognizes the impact on the vulnerable pain community.

Where Do We Go From Here

Physicians are still being prosecuted for their prescribing decisions. Pain patients are still being “cut off” by their risk adverse providers for any slight sign of aberrant behavior. State regulators, insurance companies, Medicare, and PBMs still apply dosage limits to what they believe is “appropriate care”. The stain of the 2016 guidelines will not be immediately reversed even if the new proposed guidelines take effect. Prosecutors will continue to put “expert” witnesses on the stand and claim that the principles in the 2016 guidelines are longstanding principles ingrained into the practice of medicine in an attempt to hold providers accountable for failing to adhere to their subjective standard.

For now, the best avenue of relief is through the courts, administrative bodies, and tribunals securing individual victories on behalf of providers subjected to scrutiny for their failure to adhere to guidelines that are now severely in question - if not completely rebuked. When the new proposed guidelines come out, we must prevent their admission in cases against physicians and if an expert dare apply the guidelines against a particular physician the jury must know that these guidelines are not a replacement for patient centered care and shared decision making.

And widespread relief in the courts may be on its way as the Supreme Court prepares its decision in Ruan v. United States.