Beginning in 2019, high daily dose opioid prescriptions may become even harder to obtain. Here’s what you need to know.
Last February, when the Trump administration announced new restrictions on opioid prescriptions covered by Medicare, the plan drew strong criticism from patients and physicians across the country. The proposed rule, which would have required insurer approval of prescriptions totaling 90 or more morphine milligram equivalents (MME) per day, generated nearly 1,400 online comments and they were overwhelmingly negative.
“The 90 MME hard edit guidance was strongly opposed by nearly all stakeholder groups for a variety of reasons,” the Centers for Medicare and Medicaid Services (CMS) noted two months later, in April 2018. “Physician groups opposed the forcible/non-consensual dose reductions due to the risks for patients of abrupt discontinuation and rapid taper of high dose opioid use. Similarly, we received hundreds of letters from patients who have taken opioids for long periods of time and are afraid of being forced to abruptly reduce or discontinue their medication regimens with sometimes extremely adverse outcomes, including depression, loss of function, quality of life, and suicide.”
In response to the backlash, CMS changed the rule to require consultation between pharmacists and prescribers (a “soft edit”) instead of approval by insurers (a “hard edit”). That regulation, which takes effect on January 1, 2019, and does not apply to cancer patients or people in hospices or nursing homes, in theory provides more flexibility for chronic pain patients who reach or exceed the 90 MME threshold. But in practice, pain experts say, the new requirement, which CMS describes as “a tailored approach” to “address chronic opioid overuse,” is likely to further discourage prescriptions at or above 90 MME, even when they are medically justified.
The 90 MME limit, which comes from the opioid prescribing guidelines published by the US Centers for Disease Control and Prevention in 2016, is scientifically problematic for several reasons. It assumes that analgesic effect corresponds to overdose risk and that different opioids can be reliably compared to each other based on fixed ratios. It ignores numerous factors that affect how a patient responds to a given dose of a particular opioid, including obvious considerations such as the patient’s weight, treatment history, and pain intensity as well as subtler ones such as interactions with other drugs (which can suppress or amplify an opioid’s effects) and genetically determined differences in enzyme production and opioid receptors.
It is not even safe to assume that two physicians, or a physician and a pharmacist, will agree about whether a patient has reached the 90-MME threshold. Research by clinical pharmacist Jeffrey Fudin, PharmD, who specializesin pain management at the Stratton VA Medical Center in Albany, New York, and serves as PPM’s Editor-at-Large, has shown wide variation in MME estimates between medical professionals and online calculators. “There’s no consensus guideline,” says Dr. Fudin. “You can go to three different sources and get three different morphine milligram equivalents.” So the first problem patients may encounter under the new Medicare rule is that “a pharmacist’s calculation might be different from the physician’s calculation.”
The next problem is that the newly required discussion between the pharmacist and the physician may not be easy to arrange, especially if a patient is trying to fill a prescription after office hours or when the doctor is busy. “If it takes a day or two to get that prescription approved, that patient may go through withdrawal,” says Dr. Fudin. “Once the pharmacist gets approval, they don’t have to call every month. So at least the first time the patient should see if they can get the prescription early so this can all get ironed out.” Fudin says some doctors are willing to write prescriptions as many as five days early, but that practice would also have to be allowed by the pharmacy and the insurer.
Lynn Webster, MD, a former president of the American Academy of Pain Medicine and current vice president of Scientific Affairs at PRA Health Sciences, says advance notice to pharmacists also can help. If the doctor lets the pharmacist know that a patient on a higher dose will be coming in, that he considers the dose medically appropriate, and that the pharmacist can call if he has any questions, Webster says, that exchange might even qualify as the consultation required by Medicare.
Dr. Fudin suggests that doctors prepare for possible gaps in medication by prescribing clonidine or lofexidine, which “will prevent, or significantly lessen, the withdrawal symptoms,” when taken as directed. Patients may be able to avoid that problem by forgoing Medicare coverage and paying for their medication out of pocket, assuming the pharmacist is willing to fill the prescription. That could cost as much as $800 for a month’s supply of a brand-name drug that’s still under patent, although the price could be less than $100 for something like generic hydrocodone.
The expense might be reimbursed by the insurer once the pharmacist has talked to the prescriber. Then again, insurers may impose their own requirements for opioid prescriptions, as they are permitted to do under Medicare regulations. Patients also should be cognizant of limits set by state law. For example, see the information provided by the National Conference for State Legislatures, or refer to pharmacy policies shared online by drugstore chains like CVS and Walmart.
Drs. Fudin and Webster both think the new CMS rule will have a noticeable impact on prescribing practices. Doctors undeterred by the soft edit may nevertheless switch to less expensive medications, which may be less effective or more easily abused, to reduce the burden on patients who end up paying out of pocket. Other doctors may decide to taper patients down below 90 MME, something that is already happening in response to the CDC guidelines, which are officially optional but have become increasingly mandatory as they are incorporated into laws, regulations, and insurance rules.
“This is such a hassle for both the prescriber and for the pharmacist,” says Dr. Webster, “that they don’t want to trigger some event that’s going to cost them money and time, so they'll just keep the patients below 90 MME. It places the physician and the pharmacist in a confrontational position, and the patient is going to be the real loser, because neither of them wants to be in a confrontation. They’ll basically abandon the patient’s needs. As with most of the policies to date, the people in pain who really suffer are the ones who are paying the price for the illegal use of the drugs that have been diverted.”
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