Medicare … would now refuse to pay for long-term, high-dose prescriptions; a rule to that effect is expected to be approved on April 2. Some medical experts have praised the regulation as a check on addiction.
But the proposal has also drawn a broad and clamorous blowback from many people who would be directly affected by it, including patients with chronic pain, primary care doctors and experts in pain management and addiction medicine.
Lawmakers should be concerned when the “medical professionals” that will be affected and charged with implementing this new “medical rule” are vehemently opposing it.
Critics say the rule would inject the government into the doctor-patient relationship and could throw patients who lost access to the drugs into withdrawal or even provoke them to buy dangerous street drugs.
Although the number of opioid prescriptions has been declining since 2011, they noted, the rate of overdoses attributed to the painkillers and, increasingly, illegal fentanyl and heroin, has escalated.
“The decision to taper opioids should be based on whether the benefits for pain and function outweigh the harm for that patient,” said Dr. Joanna L. Starrels, an opioid researcher and associate professor at Albert Einstein College of Medicine.
She gives three valid scientific reasons:
- “That takes a lot of clinical judgment.
- It’s individualized and nuanced.
- We can’t codify it with an arbitrary threshold.”
Of course, politicians are ignorant of the repercussions of their politically ambitious legilation, but medical professionals know better than to impose arbitrary thresholds for medications (or treatments), but the public is clamoring for the government to “fix” the “opioid” crisis.
The rule means Medicare would deny coverage for more than seven days of prescriptions equivalent to 90 milligrams or more of morphine daily, except for patients with cancer or in hospice. (Morphine equivalent is a standard way of measuring opioid potency.)
Inconvenient fact: there is NO DIFFERENCE between cancer and non-cancer pain
The Centers for Medicare and Medicaid Services estimates that about 1.6 million patients currently have prescriptions at or above those levels. The rule, if approved as expected at the end of a required comment and review period, would take effect on Jan. 1, 2019.
Dr. Stefan G. Kertesz, who teaches addiction medicine at the University of Alabama at Birmingham, submitted a letter in opposition, signed by 220 professors in academic medicine, experts in addiction treatment and pain management, and patient advocacy groups.
His patients include formerly homeless veterans, many of whom have a constellation of physical and mental health challenges, and struggle with opioid dependence.
First, we send them to be shot, then we bring them back home and deny them pain relief. (Many violent injuries don’t completely heal and will generate pain the rest of the victim’s life)
For them, he said, tapering opioids does not equate with health improvement; on the contrary, he said, some patients contemplate suicide at the prospect of suddenly being plunged into withdrawal.
“A lot of the opioid dose escalation between 2006 and 2011 was terribly ill advised,” Dr. Kertesz said. “But every week I’m trying to mitigate the trauma that results when patients are taken off opioids by clinicians who feel scared. There are superb doctors who taper as part of a consensual process that involves setting up a true care plan. But this isn’t it.”
If the rule takes effect, Mark Zobrosky’s experience could be a harbinger for many patients. Mr. Zobrosky, 63, who lives in the North Carolina Piedmont, takes opioids for back pain, which persists despite five surgeries and innumerable alternative treatments.
He has an implanted spinal cord stimulator that sandpapers the edge off agony, and has broken four molars from grinding because of pain, he said. He receives Medicare as a result of his disability, including a private plan that pays for his drugs.
He submits to random urine tests and brings his opioids to his doctor to be counted every month. To prepare for mandatory reductions, his doctor has tapered him down to a daily dose equivalent of about 200 milligrams of morphine.
(Mr. Zobrosky has a large frame; doctors say that opioid tolerance depends on many factors — one person’s 30 milligrams is another person’s 90.)
According to a draft of the rule, when a high-dose prescription is rejected, a doctor can appeal, asserting medical necessity — although there is no guarantee that the secondary insurer covering the drugs under Medicare would relent. A pharmacist may fill a one-time, emergency seven-day supply.
Opponents of the new limit say that doctors are already overwhelmed with time-consuming paperwork and that many will simply throw up their hands and stop prescribing the drugs altogether
A delay or denial would put chronic pain patients — or those with inflammatory joint diseases, complex shrapnel injuries or sickle cell disease — at risk of precipitous withdrawal and resurgence of pain, doctors said.
The Medicare proposal relies on guidelines from the Centers for Disease Control and Prevention that say doctors should not increase an opioid to a dose that is the equivalent of 90 milligrams of morphine.
The guideline says NO such thing.
Above 90MME doctors are only supposed to hesitate and be more cautious.
But experts say that Medicare misread the recommendations —
How one government agency can “misread” such a critical document and then suggest legislation dependent upon this misreading is beyond me.
the C.D.C.’s 90-milligram red flag is for
- patients in acute pain who are just starting opioid therapy,
- NOT patients with chronic pain who have been taking opioids long-term.
The acute pain patient, the guidelines say, should first be offered treatments like acetaminophen or ibuprofen.
Dr. Erin E. Krebs recently released a comprehensive study showing that patients with severe knee pain and back pain who took opioid alternatives did just as well, if not better, than those who took opioids
Nonetheless, she and seven others who worked on the C.D.C. guidelines signed the letter opposing the Medicare rule.
There’s much significance when the lead researcher of a study used to vilify opioid therapy for chronic pain signs a document condemning opioids dose limits.
It’s clear to her and many other doctors that the study was misconstrued, misinterpreted, and misapplied.
“My concern is that our results could be used to justify aggressive tapering or immediate discontinuation in patients, and that could harm people — even if opioids have no benefit for their pain,” said Dr. Krebs, an associate professor of medicine at the University of Minnesota.
“Even if we walk away from using opioids for back and knee pain, we can’t walk away from patients who have been treated with opioids for years or even decades now,” she added. “We have created a double tragedy for these people.”
Several experts have debunked the NSAIDs vs Opioid study:
- Is New Opioid Study Based on Junk Science?
- Advil Just as Effective as Opioids?
- Real World Study or Reality Show
- Sometimes the Journal of the AMA Gets It Wrong
- Stefan Kertesz Responds to Opioid vs NSAID Trial
And some interesting findings are hidden in this report:
…and proves that opioids:
- are effective long-term,
- are not very addictive and
- don’t have intolerable side effects.