Centers for Medicare and Medicaid Services (CMS) is proposing a limit on the amount of opioids a physician can prescribe to a patient. This limitation, that may take effect on Jan.1, 2019, would be unrelated to the patient's past experience or need. It would render pharmacists unable to fill prescriptions that CMS has defined as “high” or long-term dosages unless an appeal is approved.

CMS defines long-term opioid therapy as opioid use for more than 90 consecutive days and high-dose usage as at least 90 mg morphine equivalent dosage (MED) per day. However, this definition has never received substantial scientific support.

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The history of dose investigation shows that opinions about what constitutes the appropriate amount of opioids have changed through the years. To begin, a paper published 15 years ago in the

New England Journal of Medicine

suggested most people do not benefit from opioids administered above 180 mg per day. This article ignited a heated debate. However, it focused on efficacy, not the risk of overdose or addiction at higher doses.

Four years later, guidelines created in Washington State from a different set of factors suggested 120 mg as a daily ceiling dose (that figure was subsequently lowered to 90 mg MED). However, this team later published a paper stating dose was not a significant factor for overdoses, but concomitant sedative-hypnotics such as benzodiazepines and muscle-relaxants were common in most overdoses.

In 2009, the joint guideline of the American Pain Society and American Academy of Pain Medicine performed a scientific review of the literature and arrived at 200 mg per day as a typical dose. Any number above that would be considered a “high" dose.

The creators of this guideline write, “Theoretically, opioids have no maximum or ceiling dose, but there is little evidence to guide safe and effective prescribing at higher doses, and there is no standardized definition for what constitutes a 'high' dose. By panel consensus, a reasonable definition for high dose opioid therapy is >200 mg daily of oral morphine (or equivalent), based on maximum opioid doses studied in randomized trials.”

The point is that the CMS proposal does not consider the variable factors other than dose that affects the incidence of overdose deaths. It assumes there is one dosage that is correct for all patients, and that number is immutable.

A study found that in the absence of benzodiazepines, the risk of death from an opioid overdose does not substantially increase until the dose exceeds 200 mg MED. Preventing overdose requires vigilance in prescribing at all dose levels as well as knowledge of the drivers of overdose, such as dangerous drug combinations, that are independent of dose.

In setting goals for opioid dose reductions, CMS may influence other payers to create similar restrictions on prescriptions. Some insurers would likely welcome the intervention. However, the result will likely be involuntary dose reductions that may be enforced without regard to individual condition or a physician's recommendation.

Doctors fear the consequences of making a different therapeutic decision than the prescriptive directives of government agencies. They see their colleagues being pursued by the DEA for prescribing high doses of medications. Some of their colleagues have retired; others have been held responsible for patients' overdoses and have been incarcerated.

Therefore, many of them are abandoning patients on higher doses, forcing them into discontinuation or drastic reduction of doses. The unintended consequence is that some patients may turn to street drugs and expose themselves to the dangers of illicit drugs and the criminal justice system. Other patients may choose suicide over unmanaged pain.

Despite the CMS's claim, the proposal does not set a standard of care; a de facto standard of care will bleed into legal and regulatory proceedings for prescribing an opioid. Any deviation will threaten a doctor’s ability to practice medicine. The needs of the patients will not be taken into consideration.

The CMS dose ceilings will lead to coverage and reimbursement restrictions imposed outside the chronic pain population. Currently, state laws built on federal agency guidelines are beginning to interfere with the delivery of palliative, cancer, and end-of-life care. Minnesota requires Medicaid patients above 120 mg MED to go through pre-authorization.

This places a burden on patients and providers that results in barriers to care for patients who are at the end of life or who have life-limiting illnesses. Thus, the practice of individualized medicine is at risk of curtailment through policies crafted with heavy input from entities with a financial interest in dictating treatment coverage options and limitations.

CMS writes, “Lower [quality measurement] scores demonstrate less long term, high-dose opioid prescribing, resulting in a lower likelihood of adverse events associated with opioid use and, thus, higher quality care.”

On the contrary, there is evidence that a decline in opioid prescribing over the past five years has coincided with a surge of overdose deaths. Furthermore, the risk for suicides of patients left without sufficient pain relief or support during opioid discontinuation or dose reduction is real.

Finally, such actions will not reduce opioid deaths related to heroin and illicit fentanyl which is the source of most overdose deaths. In fact the opposite effect may occur. People in pain may be pushed to illicit channels causing more deaths. Solutions that are not aimed at the true current cause of overdose deaths will more likely lead to unfortunate and preventable sad outcomes.

Lynn R. Webster, MD is a vice president of scientific affairs for PRA Health Sciences and consults with Pharma. He is a former president of the American Academy of Pain Medicine. Webster is the author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.” You can find him on Twitter: @LynnRWebsterMD.