The epidemic of opioid-related deaths sweeping the country has lawmakers and regulators in Washington, D.C., and state capitals scrambling for answers. And while doctors generally welcome the attention to the crisis, many also fear that the solutions being proposed and enacted will do more harm than good.
The concern among physicians and public health and pain management experts is that laws and regulations designed to limit use of prescription narcotics, however well-intentioned, are yet another constraint on doctors’ ability to treat patients as they think best.
Worse, they say, some of the limitations on prescribing could result in patients turning to heroin or buying the medications on the street. And because heroin in particular now is often laced with fentanyl and other synthetic painkillers, doing so astronomically increases the risk of death.
Balancing needs of patients versus the community
While opioid-related deaths have been rising for well over a decade, government efforts to address the crisis only got underway in earnest in 2016. That’s when the CDC issued its comprehensive “Guideline for Prescribing Opioids for Comprehensive Pain,” and President Obama signed into law the “Comprehensive Addiction and Recovery Act of 2016.”
Opposition to new CMS Rule
The most recent action aimed at reducing opioid use occurred in April of this year, when CMS approved a rule denying coverage (with some exceptions) for Medicare Part D beneficiaries whose total daily opioid dose exceeds 90 morphine milligram equivalents (MMEs).
The rule also limits coverage for patients receiving opioids for the first time to a seven-day supply, with no exceptions.
Bureaucrats making rules for medical treatment “with no exceptions” would override ethical medical treatment in some cases.
All these anti-opioid hysterics making these restrictive rules about pain treatment have clearly never suffered prolonged pain themselves.
The rule generated significant opposition from physicians and pain experts, dozens of whom signed a letter stating, among other objections,
- that the policy isn’t consistent with the CDC guideline, and
- it doesn’t include any metrics for evaluating the rule’s impact on patient health or access to care.
Among the letter’s signatories was Thomas Tape, MD, MACP, professor of internal medicine at the University of Nebraska Medical Center, and a member of the core group of experts that advised the CDC in developing its opioid guidelines.
When even the guideline creators oppose these new rules, it seems this would sow some doubt in the minds of the rule makers.
But, no, they just double down as they always have in their drug-war: the less effective a DEA policy is, the more money they throw at enforcing it, with no regard for the collateral damage it wreaks on our society.
And they are never held accountable.
“I’m a firm believer of guidelines in terms of information to physicians regarding the hazards of high-dose opioid prescribing,” Tape explains. “But at the same time, physicians need to be allowed to exercise their clinical judgement about the appropriate course of therapy for a particular patient without interference from governmental entities, because there are so many exceptions to any general rule.”
I want to grab this guy and yell at him, “How could you not have realized that the guideline you were writing would be codified into laws?”
How can such a smart guy be so stupid not be suspicious when all the folks working on an opioid guideline for *pain* medication were addiction-ologists, without any pain specialists involved and mostly in secret.
Tape, who maintains a clinical practice, distinguishes between what he calls “legacy patients”—those who have been on high doses of opioids for months or years—and patients who’ve been prescribed opioids more recently and are still on relatively low doses.
One of the goals of the CDC guideline and subsequent laws and regulations, he says, is to ensure that patients in the latter group don’t become part of the high-dose group.
“But we also have to recognize there are no easy answers for dealing with that high-dose legacy group,” he adds.
“You can’t just make the problem go away by saying we won’t pay for that kind of [high-dose] prescribing anymore, because that throws patients into a state of withdrawal.”
At least he has one thing intelligent to say.
Like Tape, Schwartzstein believes that getting patients off opioids, or just lowering their dosages, is a difficult process that has to be tailored to each patient’s needs.
“My primary goal is to manage chronic pain so that people can be as functional as possible, so I don’t take opioid pills away from people just for the sake of taking them away.
Hurrah! Here’s a doctor who still practices “real” medicine for his patients, treating them as the complex individuals they are instead of just numbers (milligrams of opioids) on a spreadsheet.
It’s all based on an individual assessment between myself and the patient,” he says.
That’s easy to say, but all the new rules based on the CDC guideline eliminate exactly the kind of individualized treatment he mentions.
Growing ‘opioid phobia’
For Dan Glatt, MD, an internist in Burlingame, Calif., specializing in pain and addiction medicine, obstacles to prescribing opioids have come not from any new laws or regulations, but from payers.
He cites the case of two patients who’ve been stable on their medications for several years, but whose insurance (which they get through their spouses who both work for the same employer) recently began limiting its opioid coverage to 90 MME per day, far less than the patients had been using.
I still don’t understand how supposedly intelligent people think that standardized doses for such a drug as opiods is appropriate.
That’s no different than assigning standard doses of insulin to diabetics, which also vary widely in their need for this medication.
Now, Glatt says, the patients are having to pay out-of-pocket for their pain medications.
In addition, Glatt notes that a growing number of physicians in his region now refer patients to him out of what he calls “opioid phobia.”
“Docs who were prescribing now are afraid to because they don’t want to show up on a list or think the DEA is going to show up at their door,” he says. “They either want a blessing from me because they know I treat addiction and pain, or they just don’t want to take care of these patients anymore, even though the patient’s doing fine and has been stable on their meds for years.”
This shows how utterly these rules are divorced from treating patients as individuals.
Like many specialists in addiction medicine, Glatt believes the solution to the opioid crisis lies in devoting more resources to helping addicts and keeping outside interference to a minimum.
This is the real solution to our “crisis”, which is one of addiction in general.
Burdens on practice
Georgia, where internist Sandra Fryhofer, MD, MACP practices, recently enacted several laws aimed at curbing opioid abuse.
The law allows practices to assign up to two staff members to check the PDMP, thereby relieving physicians of some of the time required. Even so, “It’s going to be a burden because everyone is already busy in a small primary care office,” she says, adding that the process would be easier if the PDMP could be integrated into electronic health records.
The Medical Association of Georgia also lobbied unsuccessfully for a law that would have required commercial insurers in the state to provide coverage for opioid addiction treatments and opioid alternative treatments for patients.
It’s still cheaper to pay out-of-pocket for pain medication that try “alternative” approaches, like acupuncture and chiropractic, that require ongoing appointments to maintain the benefits.
“All these things are ways that we could keep from having to give patients pain pills,” she says.
Fryhofer adds that the law’s failure is emblematic of a larger problem:
Too few lawmakers, regulators and payers involved in trying to solve the opioid crisis truly understand its complexities or the resources the effort requires.
That’s because they’ve been flooded with misinformation put out by the anti-opioid zealots.
Tips for opioid prescribing
With all the legislative and regulatory efforts to reduce opioid use, can primary care doctors still prescribe the medications without running afoul of the law? The answer is “yes,” but experts caution that it takes work.
This is the bottom line: all these new regulations keep sqeezing doctors when they already have little “spare” time to handle all the paperwork and phone calls.
This is another insidious method of decreasing prescribing: place so many administrative burdens on opioids and threaten doctors with “enforcement” by the DEA if they prescribe “too many” (which is decided by the DEA, not a medical professional).
“If you choose to prescribe opioids for patients, the most important thing is to have properly documented records,” says Dan Glatt, MD, an internist and partner in a pain and addiction practice in Burlingame, Calif.
Anna Lembke, MD, medical director for addiction medicine at the Stanford University School of Medicine, also stresses the importance of documentation, along with determining if the patient has a history of addiction or substance abuse.
The case for outside intervention
Anna Lembke, MD, knows that where government regulation of opioid prescribing is concerned, she is an outlier.
Lembke thinks that reducing opioid use requires intervention by legislators and other outsiders.
For this alone, I would argue that she cannot be a professional doctor. Real doctors always treat each individual according to their individual background and individual needs.
No government can legislate standards for what treatment patients truly need and still call it “medical care” – this is something only a doctor working with each individual patient can determine.
Lembke’s willingness to accept government-imposed limits on opioid prescribing is based on the need to counter what she calls “perverse incentives” in the nation’s healthcare system to overprescribe the medications
Among these incentives, she says, is the influence that pharmaceutical manufacturers have wielded, and continue to wield, over organizations and agencies meant to protect patients and advocate on their behalf.
She points to a March 2018 draft report to the director of the National Institutes of Health recommending, among other actions, that the institute no longer accept funding for public/private partnerships from pharmaceutical companies involved in opioid-related litigation.
The growing number of physicians leaving private practice to work for hospital systems creates another reason for doctors to overprescribe opioids, she says.
Still another factor favoring opioid prescribing, Lembke says, is Americans’ attitude towards pain. “In general, I think the cultural trend is toward the belief that any amount of pain is too much,” she says.
That is exactly wrong: The attitude Lembke describes would only be held by what our culture thinks are sissies and wimps.
Americans believe you should “suck it up” – pain patients are told that all the time.
And while that attitude stems from a variety of causes, the pharmaceutical industry promotes it. “Their attitude is, ‘If you’re experiencing any pain, you have an illness and your doctor has a responsibility to treat that,’” she says.
No, this isn’t an attitude problem, it’s apublic health problem that’s not being addressed. Our treatment of pain is so poor that Human Rights Watch is Investigating U.S. Pain Treatment.