This article was written as a preparatory document to assist health plans and Pharmacy Benefit Managers in the Medicare Part D marketplace prepare for upcoming changes related to the 2019 opioid policies discussed in the Final Call Letter released April 2, 2018.
It’s no secret that the opioid epidemic has impacted our society, and this discussion is no longer a topic reserved for health administrators and clinicians. On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released the Final Call Letter (Call Letter) for 2019.1 A significant portion of the Call Letter focuses on the crisis and how Medicare Part D Plan Sponsors will be charged to address it, specifically around opioid overutilization management.
CMS’ discussion regarding opioids begins on page 234 of the Call Letter, titled: Part D Opioid Overutilization Policy. They group their 2019 policies into six sections:
1. Opioid naïve patients
2. High-risk opioid users
3. Chronic opioid users
4. Care coordination edit of 90 morphine milligram equivalents (MME) per day
5. Opioid users taking duplicate or key potentiator drugs
6. Quality measures
As discussed by CMS, these policies are closely aligned with the attributes of the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain — United States, 2016.2 CMS recommends Plan Sponsors be familiar with the CDC Guideline (Guideline) and how it should be used to build clinical programs. This article will review each of the six policies individually and how they tie to the Guideline, recognizing some key areas within each of these six policies that Plan Sponsors can use to assist with planning as we approach the 2019 plan year. We divided our recommendations into three categories: Clinical, Operational, and Compliance.
Policy No. 1: Opioid Naïve Patients
CMS expects all Part D Plan Sponsors to implement a hard safety edit to limit initial opioid prescription fills for the treatment of acute pain to no more than a 7-day supply.3
Clinical: Coverage Determination and Appeal (CDA) volume increases are likely. Using current utilization data statistics, Plan Sponsors should evaluate the number of Opioid Naïve Patients they have serviced and the frequency with which they have led to CDA. Added volume will likely impact CDA departments, and therefore staffing evaluations should occur to account for turnaround time requirements. Attention to CDC Recommendation No. 64 should be considered when developing parameters around this initiative.
Operational: This is going to be a highly technical function that will rely on strong coordination with your Pharmacy Benefit Manager (PBM) to ensure that the adjudication logic accomplishes shorter-day supply increments, captures the correct medications, and accurately identifies applicable patients (Opioid naïve, excluding hospice and long-term care patients). Consideration also needs to be made for Transition Fill logic and other Drug Utilization Review parameters that are embedded in the adjudication system.
For Medicare Advantage Prescription Drug Plans (MA-PDs), Provider Network teams should be educated about these edits so that they can communicate to prescribers about upcoming changes in dispensing logic and assist with prescribing parameters and references to the CDC Guideline upon which these efforts are based.
Data analytics should perpetually identify prescribers that are prescribing greater than 7-day supplies so Plan Sponsors can work with them on reducing quantities.
Coordination with other aspects of the company that may interface with prescribers, pharmacies, and patients should also be considered, especially pharmacy network departments that work directly with pharmacies. CMS expects sponsors to allow pharmacists to communicate this information through the Plan Sponsor’s help desk or through override codes for plan authorization. CMS also expects Sponsors’ network pharmacies and customer-service representatives to be adequately trained on these edits.5
Compliance: As discussed above, there is reliance upon the PBM to administer this logic through the adjudication system. The PBM most often serves as a First Tier, Downstream or Related Entity (FDR), and thus Plan Sponsors will need to ensure that oversight is being administered, audited, and monitored accordingly. These new provisions will likely require new Policies and Procedures (P&Ps), which may include P&Ps from your PBM, other FDRs (example: Prior Authorization vendor), and internal practices.
CMS discusses Plan Sponsors engagement with the Overutilization Monitoring System (OMS) to manage for high-risk opioid users. The OMS retrospectively identifies those beneficiaries considered at significant risk (using high levels of opioids from multiple prescribers and pharmacies). Sponsors then review these cases and perform case management with the beneficiaries’ prescribers.6 CMS further discusses how plans must “implement the Comprehensive Addiction and Recovery Act of 2016 (CARA) in 2019 and integrate those policies with the OMS process.”7 CARA8 outlines the process in which plans will be able to “limit at-risk beneficiaries’ coverage for frequently abused drugs to certain prescribers and pharmacies (‘lock-in’) and apply beneficiary-specific point-of-sale claim edits.”9 CMS discusses monitoring of potentiator drugs such as gabapentinoids, benzodiazepines, muscle relaxants, and other sedatives.
Clinical: Through the combined work of OMS and CARA, Plan Sponsors will need to account for care management. For MA-PDs, this will be an increase in collaboration between pharmacy and physical health teams, particularly when managing the vulnerable Special Needs Plan population. Although PDPs will have decreased ability to work cross-functionally, all Plan Sponsors have an opportunity to consider strategies working directly with their pharmacy networks and Medication Therapy Management Programs (MTMP), CMS encourages, but does not require, sponsors to also offer MTM services to beneficiaries who meet the sponsor’s internal criteria for retrospective identification of opioid overutilization, but do not otherwise qualify for MTM. These beneficiaries may benefit from MTM services, including the CMR, targeted medication reviews, and interventions with their prescribers.10
Care management efforts should consider drugs that may not be in the beneficiary profile, such as prescription opioids obtained through other means outside of their prescriber and pharmacy and recreational drug use that could be additive to the opioid and/or potentiator drug profile.
Of interest, the OMS will begin capturing information regarding the concurrent use of opioid(s) and gabapentinoids in excess of 2,400 mg.11 The CDC Guideline lists in Recommendation 1: “Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain… Selected anticonvulsants such as pregabalin and gabapentin can improve pain in diabetic neuropathy and post-herpetic neuralgia (contextual evidence review). Pregabalin, gabapentin, and carbamazepine are FDA-approved for treatment of certain neuropathic pain conditions, and pregabalin is FDA-approved for fibromyalgia management.”12 Therefore, beneficiaries may be prescribed a gabapentinoid as a first-line agent and the dose may be increased to manage their pain. Opioids may be introduced without consideration of lowering the gabapentinoid use and lead to adverse effects. Using nonopioids as first line agents may also introduce a marker to identify individuals with potential opioid use.
An increase in care management may require an increase in personnel. Accessing your data analysis tools can provide a barometer for High Opioid Users and assist in forecasting enrollment numbers relative to staffing needs.
Operational: Through collaboration with Clinical, Operations will need data infrastructure to monitor, record, and execute care management. The storage of documentation and the delivery of clinical care plans will be critical to ensure that beneficiaries who are high risk are appropriately monitored and successful outcomes are captured.
Review of current data analytic reporting should be performed to ensure that potentiator drugs are included in the analysis, as these will be identified in OMS. Drugs such as benzodiazepines, gabapentinoids, muscle relaxants, and other sedatives create opportunities for care management consultation and possible intervention.
The “lock-in” aspects of CARA will require education and communication with pharmacies and prescribers to ensure that awareness is coordinated between all parties, while effective communication with the beneficiary is achieved. This collaboration needs to include your PBM from a functionality viewpoint and for proper messaging if a beneficiary were to go outside of the agreed upon “lock-in” parameters established.
Creating “lock-in” programs can lead to phone calls to member service centers and pharmacy help desks. Because the frequency in which a beneficiary will be “locked-in” will likely be limited, it is important that staff is refreshed on these processes to ensure that they are familiar with how to handle these inquiries.
Compliance: Expanding processes will require review of P&Ps to ensure that they adequately capture the processes used for High-Risk Opioid users. There is a large auditing and monitoring component when reviewing High-Risk Opioid users as these individuals are likely using multiple pharmacies, prescribers, and multiple opioids. Plan Sponsors should review Element VI: Effective System for Routine Monitoring, Auditing, and Identification of Compliance Risks in Chapter 9 of the Prescription Drug Benefit Manual13 to see how the guidance aligns with their current P&Ps. Within Element VI is Section 50.6.9 – Use of Data Analysis for Fraud, Waste, and Abuse (FWA) Prevention and Detection,14 which requires Plan Sponsor efforts to look for possibilities of FWA in prescribing and dispensing patterns.
Through CARA, there are many functions that will be delivered through FDRs: pharmacy networks, prescriber networks, PBM, and quite possibly MTMP, care management, and print vendors (providing communications).
CMS speaks to the real-time safety edits that have already been implemented by Plan Sponsors over 2017 and 2018 and the impacts that these soft and hard edits have made. The Draft Call Letter discusses possibilities of moving to a 90 MME hard edit with 7-day supply allowance; however, this move was not adopted for 2019.15
Clinical: Continue monitoring the impacts of hard and soft edits and their effectiveness at providing clinical safety parameters versus impeding access to medications.
Operational: Ongoing monitoring of the grievances and the Complaint Tracking Module should be used to identify when beneficiaries may be impacted by these edits. Open dialogue between these teams and the clinical department is needed to share reporting and complaints related to prescription access.
Compliance: An annual review of P&Ps related to the administration of safety related edits and adjudication logic should be performed. Ensure that these changes are accounted for in new/revised P&Ps to be aligned with the 2019 Opioid Overutilization Policies. As stated above, these functions are typically managed through the PBM, and therefore FDR provisions should be measured.
This is quite an extensive policy for 2019. It is best summarized on p. 236 of the Call Letter16:
"We expect all sponsors to implement an opioid care coordination edit at 90 MME per day. This formulary-level safety edit would trigger when a beneficiary’s cumulative MME per day across their opioid prescriptions reaches or exceeds 90 MME. In implementing this edit, sponsors should instruct the pharmacist to consult with the prescriber, document the discussion, and if the prescriber confirms intent, use an override code that specifically states that the prescriber has been consulted. Sponsors will have the flexibility to include a prescriber and/or pharmacy count in the opioid care coordination edit. Sponsors will also have the flexibility to implement hard safety edits and set the threshold at 200 MME or more and may include prescriber/pharmacy counts."
Although point of sale pharmacies are part of the current delivery model and of the handling of soft and hard edits, the 90 MME change will be a new clinical function for these pharmacists. Beneficiaries who are “reaching or exceeding 90 MME” will require the “pharmacist to consult with the prescriber, document the discussion, and receive confirmation from the prescriber.” This requirement entails significant coordination between prescriber offices and pharmacy staff independent of the Plan Sponsor.
Clinical: Similar to Policy No. 1, this effort can lead to increased CDA if point of sale pharmacies are unable to reach a prescriber and confirm the >90 MME dose for the beneficiary. Considering the difficulty of speaking directly with busy prescribers, pharmacists will have difficulty discussing the >90 MME edit, therefore potentially leading to even more CDA. Creation of these edits and working collaboratively with the Plan Sponsor PBM will be important to ensure that these edits successfully work with other clinical edits that are in place and aligned with each plan, such as quantity limits and duplicate therapy.
Operational: Considering that the administration of a care coordination edit will fall to the pharmacies at point of sale, contracts between the PBM and the pharmacies will need to be evaluated to ensure that these responsibilities are outlined thoroughly. The Pharmacy Network teams will need to ensure pharmacies are held accountable to deliver these services and correspond with prescribers when necessary. This modifies the role and responsibility of the point of sale pharmacist and can lead to increased administrative costs. These considerations should be accounted for when creating bids for 2019.
An override code will be provided to pharmacists to use upon confirming the higher doses with the prescriber.17 Processes for the application of these codes will need to be coordinated with the plan, the PBM, and pharmacies to ensure that these codes are being used appropriately. (Paying attention to out-of-network pharmacies and direct patient reimbursement processes are also in scope.) Plan Sponsors will need to understand how these edits work with Transition Fill logic and ensure that beneficiaries receive the “Medicare Prescription Drug Coverage and your Rights, CMS-10147” correspondence when they are unable to receive their medication because of the care coordination edit.
This will also weigh on the prescriber community. Calls from pharmacies will likely increase when a Care Coordination edit is in place. MA-PD plans will need to ensure that education is provided through their Provider Network teams.
Plan Sponsors will also need to prepare Call Center resources with processes and override codes that are necessary for these edits.
Data Analytic teams can use the Care Coordination edit as a flag to identify individuals to be considered for care management opportunities.
Compliance: Aside from the FDR and P&P responsibilities, there is potential for audit efforts. To ensure that pharmacists are documenting their conversations with prescribers regarding the >90 MME edit and utilizing the override code, Plan Sponsors should make it clear to pharmacies only to use the override code upon completion and documentation of the care coordination activities, and Plan Sponsors may consider auditing pharmacies’ documentation.18
Under this policy, CMS speaks to the importance that Plan Sponsors maintain or implement soft edits for concurrent use of opioids and benzodiazepines and multiple opioid use.19
Clinical: Soft edits are likely in place from 2017 and 2018 plan years. Review of these edits and drug lists should be performed to ensure that the logic is still applicable. Changes to NDCs or hierarchical designations (Medispan Generic Product Identifier or First Data Bank Formulation ID (GCN)) can alter intended results of edits in adjudication systems. Special attention was called for surrounding Medication-Assisted Treatment (MAT). When such an edit is triggered for concurrent use of opioids and buprenorphine, the soft edit should only reject the opioid prescription following the buprenorphine claim and should not impede access to buprenorphine for MAT. It is very important that a sponsor should only implement this edit if it has the technical ability to not reject buprenorphine claims.20
Operational: These edits are all driven through the adjudication system and collaboration with clinical efforts, and PBM adjudication logic needs to be in place.
Data analytics should look for rejected claims due to these soft edits and identify scenarios where override codes are not used, and therefore medications are not dispensed. Plan Sponsors should work to assure that beneficiaries receive their medications and that these edits are not creating a barrier to care.
Compliance: We recommend a review of P&Ps describing pharmacy edits and any applicable FDR parameters.
Taken straight from page 236 of the Call Letter:
“CMS also uses quality measures to track trends in opioid overuse across the Medicare Part D program. To drive performance improvement among Plan Sponsors, CMS will implement technical revisions to the Pharmacy Quality Alliance (PQA) opioid overuse measures and add a new PQA measure, Concurrent Use of Opioids and Benzodiazepines.”21
CMS further discusses that monthly Patient Safety reports will continue to be distributed and that Plan Sponsors should use these to supplement their current opioid overutilization efforts.22
Clinical: Plan Sponsors should determine how they can use the Patient Safety reports within their current overutilization efforts now with the new policies presented by CMS for 2019. Additionally, review upcoming Enhancements to 2019 Star Ratings and Future Measurement Concepts to gain insight into these changes.23
Operational: Quality starts with effective data analytics to help care management teams address individuals who may be endangered by opioid overutilization. Ensuring there is close collaboration between care management teams and data analytics is significant.
Compliance: Monitoring quality can assist with identifying risks that may be threats to the Plan Sponsor. Assurance that quality is monitored and risk assessments are executed can help ensure that the Plan Sponsor and any FDRs are executing exceptional clinical quality.
As you can see, there are many common themes that are captured here to be considered to administer these new policies in 2019.
Clinical teams must consider the ramifications of new edits and how this will impact CDA, maintaining adjudication logic by updating and identifying the scope of drugs, and the increase in care management and integration with MTMP. Other considerations are evaluating how formulary design and manufacturer contracting weigh into your Plans’ strategy accounting for opioid parameters and rescue agents. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance abuse disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present.24 Clinical teams should work closely with their Pharmacy and Therapeutics (P&T) Committees; as per Chapter 6 of the Medicare Prescription Drug Benefit Manual: “The P&T committee must review for clinical appropriateness the practices and policies for formulary management activities, such as prior authorizations, step therapies, quantity limitations, generic substitutions, and other drug utilization activities that affect access. P&T committee recommendations regarding these activities are advisory only and not binding on the Part D sponsor.”25 This will ensure that they are engaged in the delivery of these programs and allow the Plan Sponsor to gather their opinions and recommendations.
Operations teams will need to evaluate how these opioid policies will impact:
Compliance teams will need to review existing P&Ps and possibly create new P&Ps to address these changes. As reviewed above, there is a large FDR component to make this a successful endeavor. Review of current auditing and monitoring programs should be evaluated and modified as required.
A successful implementation will be driven through an enterprise wide collaboration. We have discussed many different players that need to be participants to ensure that the Plan Sponsor can deliver. As healthcare providers, we all play a significant role in curbing the opioid epidemic; it is these efforts that can help ensure beneficiaries are receiving safe and effective treatment.
1 Centers for Medicare & Medicaid Services, 2019 Medicare Advantage and Part D Rate Announcement and Call Letter, April 2, 2018. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-04-02-2.html.
2 Centers for Disease Control and Prevention, CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016, 65 MMWR No. 1, March 18, 2016. https://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdf.
3 Call Letter, 235.
4 Guideline, No. 6.
5 Call Letter, 238
6 Call Letter, 235
7 Call Letter, 235
8 Public Law 114–198—JULY 22, 2016. https://www.congress.gov/114/plaws/publ198/PLAW-114publ198.pdf.
9 Call Letter, 235
10 Centers for Medicare and Medicaid Services, CY 2019 Medication Therapy Management Program Guidance and Submission Instructions, April 6, 2018.
11 Call Letter, 243
12 Guideline, 17.
13 Compliance Program Guidelines, in Prescription Drug Benefit Manual, CMS, January 11, 2013.
14 Compliance Program Guidelines, in Prescription Drug Benefit Manual, Section 50.6.9, CMS, January 11, 2013.
15 Call Letter, 246.
16 Call Letter, 236.
17 Call Letter, 247.
18 Call Letter, 247.
19 Call Letter, 251.
20 Call Letter, 252.
21 Call Letter, 236.
22 Call Letter, 253.
23 Call Letter, 121 and 252.
24 Guideline, No. 8.
25 Medicare Prescription Drug Benefit Manual. Chapter 6; Section 30.1.5. January 15, 2016.