The opioid crisis reached a new level of concern this month when President Donald Trump responded to recommendations from a White House panel chaired by New Jersey Gov. Chris Christie (R) to declare it a national emergency. As the number of opioid-related deaths surged from 19,000 in 2014 to 22,000 in 2015, insurers and pharmacy benefit managers (PBMs) have in the last couple of years been rolling out comprehensive opioid management programs for a variety of patient populations. But addressing this issue in an elderly population demands a nuanced approach as well as adherence to numerous Medicare program requirements, and Medicare Advantage and Part D sponsors are likely to adopt more prudent policies within CMS guidelines in the coming years.

“Typically, there are less members on higher doses in the Medicare population than we see in other populations. [But] there tends to be a higher percentage of chronic treatment among those on therapy,” remarks Mesfin Tegenu, R.Ph., president of PerformRx, LLC, a wholly owned PBM subsidiary of the AmeriHealth Caritas Family of Companies that recently unveiled a Medicare-specific strategy as part of its broader opioid management solution for 2018. “The biggest difference in managing the programs for Medicare populations is making sure that we follow all the CMS guidelines. Our programs are designed to meet all the requirements.”

MAOs Tighten Opioid Management

CMS in 2013 signaled its heightened expectations for Part D sponsors to address opioid overuse when it began issuing reports through the Overutilization Monitoring System (OMS) that identify Medicare beneficiaries with potential opioid or acetaminophen overutilization issues. Plans are expected to address the overuse through various improved drug utilization review controls. That policy resulted in a 61% drop in the number of Part D enrollees identified as potentially very high risk opioid overutilizers from 2011 through 2016 (see “Table: OMS Part D Potential Opioid Overutilization Rates” below).

But the launch of the OMS focused on members with the highest risk of adverse events, and CMS has encouraged plans to develop and refine their own internal criteria. The overuse criteria initially used in the OMS was for opioids with a cumulative daily morphine equivalent dose (MED) exceeding 120 mg for at least 90 days with more than three prescribers and more than three pharmacies contributing to their opioid claims during the most recent 12 months. CMS in the final 2018 Call Letter for MA and Part D plans revised that criteria by shortening the measurement period to six months and established that a patient’s average daily MED must exceed 90 mg for any duration and the beneficiary must have received opioids from more than three prescribers and more than three pharmacies or from more than five prescribers regardless of the number of opioid-dispensing pharmacies. Beneficiaries with cancer or in hospice will continue to be excluded from the review criteria.

Beginning in 2017, sponsors were expected to implement additional hard or soft formulary-level safety edits for opioids based on a specified cumulative MED. CMS for 2018 had proposed the implementation of only hard edits, but after receiving numerous comments expressing concerns about access, member disruption, operations and other issues impacting plans and prescribers, the agency opted to not finalize that proposal and instead recommended that sponsors continue using thresholds of greater than 90 mg MED for soft edits and 200 mg MED or more for hard edits as per 2017 guidance.

Tegenu tells AIS Health that PerformRx’s internal criteria for identifying potentially impacted beneficiaries is stricter than what CMS has outlined, which often results in the PBM identifying potential overutilizers before they are flagged in OMS reports. For 2018, PerformRx has designed a protocol to support its Part D clients that includes three key features:

New starts exceeding a 200 mg MED will be stopped at the point of sale (hard edit) for prior authorizations. Exceptions will be made in situations such as cancer diagnoses and hospice care.

Selected high-potency opioids will require a coverage determination.

Prior to 2018, PerformRx will contact potentially impacted beneficiaries who are in plans that choose to implement the protocol to determine dose appropriateness and potentially change prescribing patterns, thereby minimizing the impact when the edit becomes effective.

Tegenu says the Medicare-specific strategy was established in response to concerns about rising opioid misuse among an elderly population as well as the CMS recommendations. “We had seen instances where patients with a lower MED were not being captured by the criteria outlined by CMS,” he explains. “Through our own impact reports, we determined that it would be beneficial to drop the MED count to 90 Morphine Milligram Equivalents (MME) for our Opioid Management Program (OMP) to capture members earlier on.”

Meanwhile, PerformRx for its other populations will make stricter recommendations such as denying all opioid prescriptions exceeding a specific quantity and day supply limit that were not written by exempt providers (e.g., oncologists, hospice physicians) at the point of sale and allowing only a five-day supply of opioid therapy for less than 90 MME at the point of sale for new starts. Tegenu says the OMP was launched in July and that 35% of its managed Medicaid clients have already chosen to adopt it, while most of its Part D clients have also decided to roll it out.

Highmark Addresses Pain-Depression Ties

While MA and Part D sponsors are barred from sharing specifics about their benefit designs for 2018, several tell AIS Health they are considering more Medicare-specific opioid strategies. Highmark Inc., which recently received an award from the Drug Enforcement Agency for its assistance during narcotic investigations, is looking at initiatives for MA members aimed at addressing opioid misuse and dependence, according to a spokesperson. The Pennsylvania-based insurer also has programs in place that target physician prescribing patterns, and as part of providing physicians with support for members managing pain and patients demanding these drugs, takes steps to inform them of potential doctor and pharmacy shopping.

Additionally, Highmark is seeking to connect pain and mental health issues commonly affecting seniors (e.g., grief-based depression) by using a company called Quartet to scan claims data for potential behavioral health issues, says the spokesperson. Quartet then works with the MA member’s doctor to speed referrals into mental health therapy (bypassing long wait times) and enhances communication between primary care physicians and therapists.

Aetna Inc., which offers numerous initiatives to address opioid misuse across its member population, also has a multifaceted approach to addressing the issue among Medicare beneficiaries that includes:

The use of formulary and utilization management tools to promote appropriate therapy choices. Aetna Medicare’s limitations help to promote appropriate dosing and avoid extra doses of medication, says the insurer.

Starting in 2017 and continuing in 2018, Aetna Medicare will utilize soft edit messaging at the point of sale regarding high-dose opioid MED across multiple prescriptions. This soft edit creates the alert at the point of sale for the decision to then be made by the pharmacist in consultation with the prescriber.

Aetna also has pharmacists, technicians and investigators reviewing Aetna data for outlier behaviors in physician prescribing, pharmacy filling patterns and high utilization at a member level.

Likewise, western New York insurer Independent Health has Medicare-specific strategies outside of its broader protocols, such as a soft edit to stop a claim exceeding 120 mg MED at the point of sale that can be resolved by the pharmacist if deemed appropriate. If the MED is 200 mg or higher, that is a hard edit, meaning it is rejected at the point of sale and requires prescriber documentation, which is in line with CMS guidance. When asked about the difference between monitoring potential opioid overuse among seniors vs. a non-Medicare population, Vice President of Pharmacy Services Martin Burruano remarks, “It’s really the nature of the patient population, being more sensitive to the side effects of certain drugs, especially drugs that have many side effects such as drowsiness, dizziness, etc. So we want to try to control that as much as we can by limiting the dosing [of opioids].”

Independent Health also conducts retrospective reviews on a quarterly basis and has its own criteria for identifying potential overutilizers: two different prescribers and two different pharmacies, as opposed to CMS’s longstanding policy of three and three. Additionally, the MA sponsor has therapeutic duplication edits in place, monitors acetaminophen doses so that anything containing more than 4 grams a day is rejected at the point of sale and requires the pharmacist to contact the plan, and offers continuing education programs for providers that are specific to opioid drug management. “We also monitor concurrent opioid and benzodiazepine use, and we don’t block those at the point of sale because we can’t for Medicare, but we perform retrospective reviews and then do outreach to physicians about using that combination concurrently,” adds Burruano.

Also helping to lower opioid utilization in New York are separate state laws that require physicians to check a central database to see if an opioid prescription has been written for a patient by another prescriber and a seven-day first-fill limit on narcotics. Even though the latter policy is for non-Medicare patients, Burruano says it has flowed over to MA because it has become part of physicians’ prescribing practices.

OMS Part D Potential Opioid Overutilization Rates, 2011 – 2016

OMS Part D Potential Opioid Overutilization Rates, 2011 – 2016

*Includes partial year inactive contracts; hospice and cancer patients are excluded from utilizer and potential overutilizer counts. For these opioid utilization comparisons, CMS used Overutilization Monitoring System (OMS) methodology and prescription drug event (PDE) TAP Data processed with cut-off dates in early January of the following year.

SOURCE: CMS, final 2018 Call Letter for Medicare Advantage and Part D plans, published April 3, 2017.