The Centers for Medicare & Medicaid Services (CMS) held a webinar on December 27, 2018, to help providers understand the new guidance for prescribing opioids to Medicare beneficiaries – and if you didn’t listen in, you missed a good one. Here is the fact sheet for reference. My first thought was, “Can’t we just leave the older citizens alone?!” Are you really going to make all these folks with aches and pains from years of hard work jump through prior authorization, exceptions, and quantity limitation hoops? Well, in short, yes, these safety initiatives are indeed needed. The impact of addiction in the elderly can be even more dangerous than in younger patients. We also cannot forget that senior citizens are not the only demographic in the Medicare population. There are many younger folks with disabilities within the benefit who have a long life ahead of them to be free of dependency or addiction.

There is also the problem of diversion. If a senior appears to keep losing her Vicodin^®, is it really she? Or is someone with access helping themselves to meds from the medicine cabinet in the bathroom? We seem to spend a lot of time and effort on “child proofing” our homes and products to keep our children safe. We should also make sure excess and unwanted controlled substances are not available to help with circumventing diversion issues.

But back to the seniors. I also think there is definite need for safety considerations. We know that opioids cause respiratory depression, drowsiness, and constipation. These can be lethal side effects for a group whose lungs may not be working well and are already primed for falls due to the effects of age on balance. Constipation, causing straining on the toilet, can be a real killer for those with cardiac ailments. Seniors are also at risk for the deleterious effects of concomitant usage of benzodiazepines and opioids. It is important to help educate beneficiaries of the harm that can be caused at the time they pick up either drug at the pharmacy. I believe the new opioid prescribing guidance, while a little more work, is a step in the right direction for safe use in seniors and prevention of diversion.

The presentation highlights hinged on a three-pronged approach to the rampant opioid abuse problem – prevention, treatment, and data utilization. I will mainly talk about prevention and the myths attached CMS endeavored to dispel. And as always, unintended consequences will be pointed out so practitioners can be ready to meet them head on should they arise. It should be noted these new guidelines will not apply to any beneficiaries residing in long-term care facilities or who are receiving hospice, cancer, or end-of-life care. Patients receiving medication assisted treatment (MAT) for dependency such as buprenorphine or methadone will also not be affected by the new guidelines.

Prevention methods are based mainly at the point of service. They include soft edits and an optional safety hard edit. Soft edits will include a seven-day supply limit for initial fills of opioid medications in the opioid naïve. Opioid naïve is defined as anyone who has not received an opioid medication within a minimum of a 60- day look-back period. CMS 2019 Medicare Part D Opioid Policies: Information for Pharmacies suggests a look-back period may generally be considered to be 60 to 90 days. This makes sense as immediate pain relief needs must be met but should not prime the patient for dependency by providing an extra supply. Another soft edit to be utilized is a flag when cumulative daily doses reach 90 morphine milligram equivalents (MME). An override may be provided by the plan if the pharmacist knows the beneficiary is part of an excluded group or if there has already been a provider consultation. When there are no previously known exclusions or provider consultations, the provider must be informed before an override edit can be used to fill such prescriptions. The consultation is important as the prescriber of the drug pushing the beneficiary over the threshold may not realize the beneficiary is receiving opioids from other providers. This offers the opportunity for earlier intervention before the MME creeps up to cause greater tolerance, dependency, and greater taper and withdrawal problems. Discussions should always be documented to include date, time, name of provider, and short note confirming prescriber’s intent for the beneficiary to receive dosage in question. Number of attempts to reach the provider should also be recorded. Two very important soft edits are the opioid/benzodiazepine use flag and duplicate long acting opioid drug usage. And finally, CMS is allowing an optional hard edit at 200 MME or greater cumulative daily dose. The combination of these safety and prevention edits will keep seniors safer and perhaps lessen diversion of these dangerous drugs.

Anytime there is a guided change in prescribing habits, practitioners may worry they are not following guidance and laws to the extent necessary. This can result in the pendulum swinging too far the other way and prescribers becoming too restrictive. CMS has taken great pains to address head-on misconceptions about the new guidelines. The first “myth” they dispel is that all beneficiaries will only be able to receive seven days of an opioid at a time. Again, this is only for opioid naïve patients. And in the case of a beneficiary needing longer therapy, perhaps from a complex surgery or other trauma, the prescriber and/or beneficiary can request a coverage determination for receipt of a longer duration of therapy. The second “myth” to be addressed is that CMS is forcing all beneficiaries to taper or lower their opioid intake below a certain threshold. There is no such intention on the part of Medicare. The intent is to have beneficiaries receive the pain therapy they need at the lowest and safest effective dose, which includes care coordination between providers and close regard for all other medications being taken at the same time. And the last “myth” is that Medicare is effectively tying the hands of prescribers when their patients may need higher dose therapy. If a patient is in need of higher dose therapy, the physician should request a coverage determination and attest the dosage is medically necessary. CMS does not want to see their beneficiaries miserable and in pain but rather have them, along with their providers, make informed decisions on effective and safe therapies.

There are always unintended consequences. Whenever I think of frail beneficiaries whose first language may not be English and then juxtapose them with “coverage determinations” and “appeals,” my mind is boggled. These beneficiaries may not have the competence or patience to effectuate these patient rights, resulting in foregoing much needed therapy. It will be important for prescribers and pharmacists to keep an extra eye out for these beneficiaries to ensure they receive the pain therapy they truly need. And let’s talk about those pharmacists and prescribers! They are both overburdened and overwhelmed by the requirements of hundreds of health plans, the dearth of time that can be devoted to an individual patient, and having to do more with less in this time of escalating healthcare costs. CMS states prescribers should make every effort to take pharmacist calls in a timely manner to prevent delays in receiving medications and to make the new guidelines work effectively. It is the desire of every medical practitioner to be able to make care coordination expeditious and efficient. We may have a ways to go, and I look forward to the continued creative thinking needed to firm up the “team” concept so all manner of practitioners can get the information they need to attend to their patients in a timely manner. There are always challenges with new programs, but I believe CMS is taking the lead in helping to lessen an opioid problem that has been growing steadily over the last 10 years.

Gorman Health Group also takes the lead in providing healthcare consulting and has a bevy of creative thinkers. We can help you logically think through and operationalize the new opioid guidelines. Contact us to get this done so our Medicare programs can be the guiding light for other commercial health plans to follow!

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