There is no denying the fact that there is an opioid crisis plaguing America. There are many reports on how it affects the health outcomes of those addicted, and the strain they put on the US healthcare system. It is an epidemic affecting every age group. According to one report, nearly 12 million Medicare beneficiaries received at least one prescription for an opioid painkiller last year at a cost of $4.1 billion. There are many measures being taken by CMS, the state legislatures, and the federal government to curb this crisis. However, some measures might have unintended consequences when it comes to Medicare Part D patients and painkillers.

Centers for Medicare & Medicaid Services adopted a policy in 2013 for Medicare Part D plan sponsors to implement enhanced drug utilization review. This plan hopes to curb overutilization, which is defined as a use of opioids with a cumulative daily morphine equivalent dose exceeding 120 mg for at least 90 consecutive days. CMS has developed a comprehensive morphine equivalent dose (MED) approach to assist Part D sponsors in identifying high risk beneficiaries. Beneficiaries who are dispensed opioids that exceed 120 mg of cumulative MED for at least 90 consecutive days, and whose opioid prescriptions are associated with more than 3 prescribers and more than 3 pharmacies are identified as high-risk beneficiaries (potential opioid overutilizers).

The Overutilization Monitoring System (OMS) is the tool designed and implemented by CMS in July 2013 to oversee sponsors’ compliance with CMS’ opioid overutilization policy. Through the OMS, Part D sponsors are provided quarterly reports on high risk beneficiaries and are required to provide CMS with the outcome of their review of each case. The CDC notes that improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose from these drugs.

In the 2016 Call Letter, CMS noted that three opioid overutilization measures were in development by the Pharmacy Quality Alliance. CMS further stated that if these measures were endorsed by the PQA prior to the 2017 bid deadline in June 2016 that they may be adopted as future display measures or alternatively be used in the Overutilization Monitoring System (OMS). CMS expects sponsors who adjudicate pharmacy claims at Point of Sale to implement formulary-level cumulative MED Point of Sale edits effective January 1, 2017. PQA’s three opioid measures examine multi-provider, high dosage opioid use among individuals 18 years and older, without cancer, and not in hospice care.

Here is a breakdown of PQA’s opioid measures: Measure 1 (Opioid High Dosage): The proportion of individuals receiving prescriptions for opioids with a daily dosage greater than 120 mg morphine equivalent dose for 90 consecutive days or longer.

Measure 2 (Multiple Prescribers and Multiple Pharmacies): The proportion of individuals receiving prescriptions for opioids from four (4) or more prescribers AND four (4) or more pharmacies.

Measure 3 (Multi-Provider, High Dosage): The proportion of individuals receiving prescriptions for opioids with a daily dosage greater than 120 mg morphine equivalent dose (MED) for 90 consecutive days or longer, AND who received opioid prescriptions from four (4) or more prescribers AND four (4) or more pharmacies.

What could this mean for pharmacies and Medicare beneficiaries? If these reports begin to have an impact on sponsors and formularies, pharmacies around the country could be put into difficult situations later on. If this category of high risk beneficiary has an impact on a pharmacy’s Star Rating, it may create a myriad of problems. These newly categorized high risk beneficiaries could wind up increasing DIR Fees. This in turn could make certain pharmacies less motivated to continue serving these high risk patients, which would also be a costly decision. Either way, it could be a financially precarious situation for pharmacists.

Fortunately, CMS is not recommending the addition of these measures to the Star Ratings at this time due to concerns about the current lack of clinical guidelines regarding the use of opioids to treat chronic, non-cancer pain and pending additional analysis on diagnosis data sources, such as newly available encounter data for Medicare Part C and resolving timing issues of RAPS file updates, which are used to identify exclusions for certain cancer conditions. Research has shown that 50% of older adults who live on their own and 75-85% of the elderly in care facilities suffer from chronic pain, and any interference with providing care to these patients can have serious consequences. Pharmacists may be reticent to fill all prescriptions, or formularies may prevent patients from filling multiple opioid prescriptions even if they are covered in the patient’s current Medicare plan. It has the potential of being a really tricky situation leaving pharmacists caught in the middle between plans, CMS, and the needs of their patients. Although this is not an issue that will affect American pharmacies in 2017, it is something to be aware of as the opioid epidemic continues to expand.