There are many changes to Medicare over the course of the year and one of the biggest for 2019 has been the introduction of new opioid rules. The Centers for Medicare and Medicaid Services (CMS) have implemented new rules commencing in January of 2019 that govern the prescriptions of high doses of opioid pain medication.
The essential goal of these new rules is good from a moral standpoint in that they are designed to combat the overuse of opioids. These new strategies announced by the CMS are directed as “proactive steps” and apply only to recipients of Medicare’s Part D prescription drug plan and the Medicare Advantage program.
Patients in palliative care and hospice care are exempt, as are those patients involved with any “active” cancer-related pain.
There have been concerns about the changes to Medicare Part D associated with these rules, however, and many patients and physicians across the country have been vocal in their opposition. In response to this backlash, the CMS actually augmented the rules to adapt to patient concerns.
From a Hard Edit to a Soft Edit
Now, the new rules are rather complicated and the specifics of what’s changed can be explored thoroughly via the CMS website. Under the “Improving Drug Utilization Review Controls in Part D” portion of the website, users can find information about the Comprehensive Addiction and Recovery Act (CARA) and any subsequent drug management programs that could affect how pharmaceuticals are administered.
The basic gist is that these drug management programs are designed to “flag” high-risk patients, like those who take different combinations of drugs or those who have opioid-related prescriptions from more than one physician. When these patients are flagged, a “safety edit” will kick in. That “safety edit,” designed initially to activate at doses at or above 90 MME (morphine milligram equivalent), will trigger the pharmacist to contact the physician.
If the pharmacist is satisfied by his or her conversation with the physician, that safety edit can be lifted from the file and the prescription can be filled accordingly. Prior authorization can also override any safety edits on the file. According to data, this rule could impact roughly 1.6 million Medicare recipients.
Furthermore, a “hard edit” can be imposed by insurance companies for those receiving 200 MME or more of opioid-related pharmaceuticals. They can also obtain controls to send patients to only “approved” pharmacists or pharmacies and can identify patients thought to be at a “high risk” for addiction.
The CMS changed that aforementioned “edit” into a so-called soft edit, which allows greater flexibility for cancer patients and the like and makes more allowances for those at the 90 MME threshold.
Problems and Limitations
Without delving into any political distinctions, it’s important to note here that it is insurance companies and pharmacists that make the final call with respect to these prescriptions. While addressing opioid use does indeed require action, determining risk and difficulty with only cursory input from a physician seems misguided.
There is also the practicality of the matter. Having pharmacists telephone or otherwise contact doctors can turn into a rather cumbersome process in the best of times, but the logic of it does not seem sound. For this reason, many in the pain management field believe that the dosages of prescriptions may fall to just below the threshold so that those phone calls are not triggered.
While this may seem like a less than problematic solution to the problem, it could actually result in underdosing patients and undercutting the correct dosages – all to save time and complication.
Patients who do not have a dosage “approved” through this process can file an appeal or otherwise pay for the prescription out of pocket, which means that Medicare Part D is not used to cover medications. That’s good news, as it means that Medicare’s denial does not have the power to undercut the prescription itself.