Medicare Rule Will Create New Challenges for Chronic Pain Patients
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 confrontationtoo many chiefs and not enough Indians. 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.”
There is this old idiom … “too many chiefs and not enough Indians” which boils down to … ” in an organization, there are too many people in charge and not enough people doing the work” In the new Medicare opiate guidelines that take effect Jan 1, 2019… we have too many people who perceive that they have some sort of “professional discretion” and/or some “professional obligation”
Their decisions may be based on personal opinions or biases. Corporate policies created that may have more to do with protecting the corporation from a legal perspective (fear of the DEA) , actions taken to enhance or protect the corporate bottom line or state edicts/laws that may or may not have certain exceptions for certain pts (cancer, hospice, nursing home).
The pt may be dealing with a multiple of subjective diseases (pain, anxiety, depression) where there is no objective test to have a bench mark to reach or maintain which is considered some sort of presumed “normal level”.
We have already seen where individual healthcare professionals, corporations, states have taken the 90 odd pages of the CDC opiate dosing guidelines and find one sentence or paragraph that they are found of and make it their entire policy when dosing opiates for pts in chronic pain.
As pointed out in this article, most of the opiate conversion programs may or may not agree with each other and at best these conversion programs are “CRUDE ESTIMATES AT BEST” and apparently with the likes of the DEA who seem to believe that these conversion programs are accurate and irrefutable. What else would you expect out of agency that is made up of LAW ENFORCEMENT ?
Our country is a country of LAWS and our laws are out there with numerous INTERPRETATIONS, but opiate conversion programs and the appropriate opiate dosing to meet the needs of a pt.. should be done via a “cookie cutter formula” ?
My recommendations to pts is that it is legal by federal law – some states may have different limitations – for the prescriber to write for a 90 days supply of the pt’s opiates in December 2018 so to allow all the dust to settle before the pt needs their next new order filled. The last thing that a chronic pain pt needs is to need a fill their next controlled med Rx the first week of Jan 2019… the system is going to be full of unanswered questions and that means that when that happens.. the pt gets told – NO NOT TODAY !
Just ask any pharmacist that was around when the Part D program began in Jan 1, 2006. All too many pts timed their refills so that they would be due the first week of Jan 2006 and the Part D billing system literately FELL APART and a lot of pts were told that their new Part D insurance would not approve the payment of their meds. Personally, back then… I timed Barb’s refills for no earlier than Jan 15th, 2006 hoping that if/when the system didn’t perform as promised that there would be such an uproar by Medicare folks not getting their meds promptly paid for … that within 2 weeks … things would be straightened out… and when I went to fill Barb’s Rxs after Jan 15, 2006… the system was functioning as designed.
This time, since controlled meds are involved.. I suspect that there will be no “I will lend you a few to get you by” like there was done in 2006. You try to get your next controlled med Rx… the pt will either be told YES or NO… Consequences to the pts being told NO… will not be a concern to all those involved… they will not FEEL YOUR PAIN !
Filed under: General Problems
This is WRONG. CMS Medicare has a responsibility more so than any other Insurance…to follow Best Practices. The American Medical Association has Now Sopken out Against the very use of CDC Guidelines 90 Mg MME Opioid Dose Cutoff stating clearly this is NOT to be used as law by Payers, Insurance Companies, Doctors etc…Also the HHS Inter Agency Pain Task Force stating exact same thing…CDC Guidelines are not to be mandated as Law. Medicare has a responsibility to their beneficiaries to follow Best Practices & “Rescind” the Soft & Hard opioid dose Edits BEFORE January 2019. They implemented these “Edits” based on the very wrong, flawed, harmful & egregious CDC Guidelines that are now being advocated Against by Organizations…they need to Rescind this immediately before pain patients are being denied their medications in January, thrown into horrific withdrawals & pain & we lose more to Suicide.
That’s the trouble with GOVERNMENT HEALTHCARE vs. PRIVATE. The government givith and the gov takeith away! In private, YOU ARE THE CUSTOMER to please. In government healthcare, YOU ARE A LIABILITY. So when old Bernie gets up there singing the praises of single payer healthcare, I think how naive his followers are.
I DREAD the day I am forced to go on Medicare and might just pay the extra fee to stay on Atnea which has been fabulous.
Conchgirl, usually private insurance companies follow Medicare. But, it might take a year or two.
Almost all, if not all doctors read that federal law to apply to three separate prescriptions for Schedule Ii. The same applies to pharmacists. I do not see any insurance company paying for 90 days of a Schedule II for a chronic pain patient. Unless it is mail order. In addition many state laws will not allow it.
Your suggestion about getting the prescription early. Seems like the most helpful. That way the pharmacist will have several days to talk to the doctor.
Getting the Rx a few days early sounds like a nice idea, but (having been on medicare for several years) I haven’t found that it’s possible to get a Scheduled med early at all. maybe if one can pay out of pocket (& the idea of getting reimbursed later is just laughable)…but me & a whole lot of other CPPs can’t possibly afford it. As usual, poor folks are screwed, CPPs are screwed, & poor CPPs really oughta do like society wants & just remove themselves/ourselves from being a burden on it. Who cares if we worked for decades, gave 1000s of hours of volunteering to educating children? What have we done for it lately?