The opioid crisis claims more than 100 lives a day. It’s ripping apart families from affluent suburbs to Rust Belt cities and swelling emergency rooms and county jails. But as lawmakers scramble to enhance regulations on prescription, there’s fear that a political panic might impose a cure that’s worse than the disease.
Trump entered office promising to rein in the opioid crisis by reforming health-care policies and cracking down on drug sales. Congress is meanwhile pushing aggressive law-enforcement and regulatory measures. A newly passed House bill, combining about 60 different proposals, would impose prescription limits, expand research and treatment programs, and promote alternatives to opioid medications to help stem addiction. Already, some advocates have criticized the legislation as too soft on pharmaceutical corporations, which lobby fiercely against regulations on distribution and marketing of drugs.
Yet resistance is emerging in the medical community as well, amid an ethical debate over how to restrict clinicians from over-prescription without constraining doctors too harshly at the expense of critical care.
The latest proposal to limit opioid prescription coming from Washington targets dosage standards for coverage under Medicare-related insurance. Last March, the Centers for Medicare and Medicaid Services (CMS), which administers federal Part D prescription drug plans, floated a tightened limit on dosage in Medicare insurance-payment standards, in an effort to tackle opioid overuse in a major at-risk group, aging Medicare patients. But the proposal was later walked back following public criticism, when some doctors warned that tighter restrictions could actually result in aggravated pain, addiction, or both.
One group of medical professionals published an open letter about the CMS guidelines, arguing for a more balanced approach to both safely treat chronic pain and safeguard against drug addiction. They argue that the payment rules proposed by CMS, which would limit dosage to 90 milligrams of morphine per day, could impact about 1.6 million patients. (Previously, the CMS proposed a general 200 milligram ceiling.) Under the CMS system, prescribing a dosage beyond the threshold would be blocked, pending a waiver from the insurer, which generally requires doctors to explain a patient’s exceptional circumstances, such as a particularly intense disease like terminal cancer, or hospice care.
The scale of the potential impact on patient populations, which would eclipse the half-million patients receiving high dosages under the previous standard, has made some providers alarmed about a possible secondary health-care crisis stemming from over-regulation. While there is clearly a need to control the annual cost of opioid prescriptions under Medicare, which has exceeded $4 billion, extreme regulation could lead to more catastrophic consequences by forcing patients to turn to the black market. When overly restrictive dosage limits drive patients toward illegal alternatives to prescription pills, such as street heroine or fentanyl, the result is increased overdoses, infectious disease through needle injection, and less-effective pain treatment, alongside a trend of increased incarceration for opioid-related crimes.
The more than 100 signatories of the open letter, including several experts who helped write the Centers for Disease Control guidelines on opioids, contend that, while regulating prescriptions was an important part of preventing drug abuse, a “knee-jerk” response was not the answer. “While a strong case can be made for consensual, supported opioid dose reductions for voluntary patients, no data support nonconsensual/forcible dose reductions or curtailment in otherwise stable patients,” they wrote, which could lead to doctors’ unnecessarily cutting back on prescriptions, and perhaps have the unintended effect of “emotional trauma, medical or psychiatric deterioration.”
One of the authors, Dr. Stefan Kertesz of the University of Alabama at Birmingham, noted that since late 2016, paralleling an upward trend in opioid-related deaths, there has also been anecdotal evidence among practitioners of the consequences of cutting off drug access: “many reports of pain patients subject to opioid termination who committed suicide, attacked physicians, died in withdrawal, suffered medical decline, or overdosed on illicit opioids.”
CMS has responded in recent weeks to the public criticisms by amending its proposal, allowing clinicians more flexibility in prescribing opioids. The new version recommends a more “tailored approach,” directing doctors to apply an “opioid care coordination edit” based on the 90 milligram standard. Hitting the threshold wouldn’t result in automatic blockage of payment but, rather, a process involving closer monitoring through consultation with pharmacists.
But the regulatory changes won’t resolve the underlying ethical dilemma facing doctors: dealing with the three-way pressure of regulators, ongoing and often urgent patient demands for medication, and a professional commitment to healing while doing no harm.
In a follow-up correspondence, one of the main authors of the letter, Kertesz pointed out that private insurers and states typically set their own guidelines for insurance coverage, and private insurers are free to further narrow their payment limits as a precaution. Additionally, he adds, “Private insurers are hard to scrutinize,” because payment decisions are largely outside public purview, making it difficult to assess how individual insurance plans are impacting dosage and treatment outcomes.
But incentivizing (or frightening) doctors into prescribing smaller doses only goes part of the way toward dealing with patients who are struggling with multiple crises in their lives, from poverty and depression to inadequate health insurance.
The question of how to deal humanely with opioid abuse is particularly raw in the politics of this new drug war. As the Trump administration threatens to further criminalize opioid abuse, harm-reduction activists fear that the lessons of past drug wars still haven’t been learned: To practitioners and consumer rights advocates, rampant opioid addiction is a byproduct of a broken health-care system, plagued by structural gaps in coverage, underfunded services, and inadequate regulatory oversight or research on effective pain management. Those needs can only be met through a long-term, integrated approach that balances patients’ and clinicians’ interests.
One promising case study comes from doctors with Southern California’s Kaiser-Permanente health system: Doctors have developed a more comprehensive opioid-control program that centers on working with patients to tailor treatment plans, to steer vulnerable patients away from riskier medications, and to “step down” to alternatives, by monitoring them cooperatively, not punitively, through honest dialogue.
The new House bill and the new guidelines could be a promising start for reform, but state and federal politicians remain in the grip of public opinion, fear of potential overreaction, and Big Pharma lobbyists, who still shape the congressional debate about prescription-drug policy. According to Kertesz , more honesty about the crisis is needed on all sides:
We are in the middle of a reaction to something that was both inappropriate and harmful. Opioid prescriptions were pushed recklessly, across the health system.… So what we are seeing is the reaction to that. But the reaction is simplistic. It is narrowly focused on “managing the pill” rather than careful deliberate decisions about what would protect the patients as human beings.
The treatment of addiction encompasses much more than insurance rules and computerized vetting systems at pharmacies. Doing pain relief on the cheap was how the opioid epidemic was spawned in the first place. Trying to fix it on the cheap could prove equally painful.
Editor’s Note: A previous version of the article incorrectly stated that half a million Medicare patients died of opioid overdose in 2016. In fact, 42,249 people died of overdoses involving opioids in 2016, including Medicare patients.