The Centers for Medicare & Medicaid Services (CMS) has stated its goals to improve access to prevention, treatment, and recovery support services to prevent the health, social, and economic consequences associated with opioid misuse and addiction and to enable individuals to achieve long-term recovery. CMS published its five-point strategy1:
- Better addiction prevention, treatment, and recovery services
- Better pain management
- Better data
- Better targeting of overdose reversing drugs
- Better research
As part of its initiatives related to pain management, CMS published Part I of the 2020 Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part D Payment Policies (the 2020 Advance Notice) on December 20, 2018.2
CMS began reporting measures related to pain management in the patient safety reports for 2018. The measures included concurrent use of opioids and benzodiazepines, polypharmacy use of multiple anticholinergic medications in older adults, and polypharmacy use of multiple central nervous system-active medications in older adults. CMS plans to add these measures to its display page for 2021 (using 2019 data) and 2022 (using 2020 data).3
CMS is proposing several new policies for 2020 that are designed to assist Medicare plan sponsors in preventing and limiting opioid overuse.1 The policies are designed to encourage Medicare Advantage (MA) plans to offer supplemental benefits. The benefits would include medically approved non-opioid pain management and complementary treatment, such as peer support services, to facilitate recovery and to navigate healthcare resources, chiropractic services, acupuncture, and therapeutic massage furnished by a state-licensed massage therapist. The massage must be ordered by a physician or medical professional to be considered primarily health related and not primarily for the comfort or relaxation of the patient. The non-opioid management item or service must treat or ameliorate the impact of the injury or illness (e.g., pain, stiffness, and loss of range of motion).
The policies are also intended to encourage Medicare Part D sponsors to offer lower cost-sharing for opioid reversal agents such as naloxone. CMS strongly encourages Part D sponsors, at a minimum, to place naloxone products on the plans’ generic formulary tiers and to place them on a formulary tier with zero or low cost-sharing for plans using such a formulary model3. CMS states benefit designs that inappropriately restrict naloxone access to products for beneficiaries for whom the drug is clinically appropriate will not be approved.6
CMS also encourages the co-prescribing of naloxone with opioid prescriptions to beneficiaries who are at increased risk for opioid overdose. CMS wants plan sponsors to ensure authorizations are in place for beneficiaries who are more susceptible to opioid associated harm. CMS is also prompting plan sponsors to provide patient-specific pharmacy messaging to alert pharmacists to provide naloxone to at-risk beneficiaries taking opioids in states that allow for standing naloxone orders.2
Consistent with these goals, MA organizations are eligible for bonus payments from CMS so long as the organizations meet the quality standards under the Star Ratings program. In connection with pain management, CMS is proposing changes to the Star Ratings program to advance opioid-related measures. CMS currently includes on its display page three measures showing use of opioids at high doses and from multiple providers. CMS proposes additional separate display measures related to the use of opioids at high dosages and from multiple providers and another measure related to the concurrent use of opioids and benzodiazepines. CMS expects to consider these measures for inclusion in the 2023 Star Ratings based on 2021 data.4
Gorman Health Group recommends adopting a strategy for the management of opioid utilization that embraces the spirit of CMS policy for the prevention of abuse, safe, effective pain management, and multiple treatment options for at-risk members. To accomplish this goal, integrating clinical pharmacy, data analytics, case management, and the medical director within the plan for an end-to-end strategy is essential.
Better Case Management
Case managers have the expertise and knowledge to assess individual needs, identify treatments, and provide education to the patient and family system. Since an opioid addiction is complicated by life-or-death consequences, a comprehensive and timely approach is essential.
One of the strongest rationales for case management in opioid addiction evaluation and treatment may be that care managers consolidate a single point of contact for clients who receive services across multiple agencies. This reduces a haphazard communication structure and increases the potential for success.
Case managers function well as the point person to gather information from professional assessments, identify social determinants impacting addiction treatment, seek community support and housing for the addict once treatment has completed, and function as a resource for the entire interdisciplinary team.
Each of these strategies is part of a multi-step approach and requires the integration of a team of committed professionals aimed at positively impacting repercussions in the community and in the family.
Pharmacy Benefit Managers (PBMs)
PBMs can use several approaches to improve the
safe use of prescription opioids. First, PBMs utilize “formulary controls” to
guide patients and prescribers toward the safest, most cost-effective
medications and cover these drugs at lower member cost-sharing to encourage
their use. The degree to which PBMs have effectively deployed these programs
with a priority towards maximizing the safe use of opioids leaves additional
opportunities for improvement. Some products, such as extended-release
hydrocodone, promethazine with codeine syrup, and carisoprodol have been
excluded from some formularies due to concerns about the potential for
non-medical use. The ultimate goal of formulary design should be to ensure
safe, cost-effective therapy and better quality of care, consistent with the Centers
for Disease Control’s (CDC’s) “Guideline for Prescribing Opioids for Chronic
Pain” across the spectrum.
Better Data Management
In addition to formulary design, PBMs employ utilization management programs such as concurrent drug utilization review, prior authorization, precertification, and quantity limits to reduce non-medical use and diversion.
Many PBMs also perform prescription claims reviews using software algorithms to identify prescribers, pharmacies, or patients who may be using opioids unsafely or else potential fraudulently prescribing, dispensing, or using opioids. Since PBM surveillance criteria are proprietary, little is known regarding their validity such as how closely they are associated with opioid-related injuries, deaths, healthcare use, or spending. However, analytics identifying at-risk members is often delayed and sometimes unactionable.
Plans should partner with their PBM to develop more timely and specific data based on the plan’s demographics to develop more creative and effective options for data management.
Better Policy Guidelines
CDC released its clinical use guidelines for the use of opioids for patients, prescribers, and pharmacies. As a starting point, plans should consider adopting these practice guidelines as a foundation for developing its own opioid management strategy. Use of safety limits for safe dosing of opioids, a clearly defined pathway to case management referrals, and defined care plans for at-risk opioid users, including escalation steps for treatment and ongoing maintenance programs that include alternatives to medication-assisted treatment plans, are the tools for a successful program.
Plan sponsor strategy for improving the safe use of prescription opioids addresses the following topics:
- Optimizing prescription drug monitoring programs
- Standardizing clinical use guidelines
- Standardized treatment guidelines for opioid use disorders
- Improving surveillance
- Implementing innovative engineering strategies
- Engaging patients and case managers
- Engaging PBMs and pharmacies
- Improving naloxone access and use
- Combating stigma
CMS is balancing the goals of improvement in the quality of care for patients needing pain management with the public health crisis arising from overuse or misuse of opioids and treatment of new cases of opioid use disorder. In furtherance of these goals, CMS continues to compel Medicare plans to adopt policies and practices designed to monitor and control opioid use while at the same time making appropriate medication available to vulnerable populations suffering from chronic pain. CMS’ policies in this area are still developing, as shown by the new display measures CMS is implementing in connection with the Star Ratings program. All these actions by CMS are part of a long-term strategy to address the pain management needs of Medicare enrollees5.
- CMS. Part II of advance notice of methodological changes for calendar year (CY) 2020 for Medicare Advantage (MA) capitation rates, Part C and Part D payment policies and 2020 draft call letter 2000, p. 186. www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/ Downloads/Advance2020Part2.pdf. Accessed February 21, 2019. In addition, on December 28, 2018, the U.S. Department of Health and Human Services (HHS) Pain Management Best Practices Inter-Agency Task Force issued a draft report calling for individualized patient-centered pain management; comments are to be received by April 1, 2019. HHS press release: Pain Management Task Force calls for patient-centered approach to improve treatment of pain, December 28, 2018, 83 Fed. Reg. 67729, December 31, 2018.
- CMS. Fact sheet: 2020 Medicare Advantage and Part D Advance Notice Part II and Draft Call Letter. www.cms.gov/newsroom/fact-sheets/2020-medicare-advantage-and-part-d-advance-notice-part-ii-and-draft-call-letter. Accessed February 14, 2019.
- CMS. Part II of 2020 Advance Notice, pp. 135-136.
- CMS. Part II of 2020 Advance Notice, pp. 175, 187. CMS. Fact sheet: 2020 Medicare Advantage and Part D Advance Notice Part II and Draft Call Letter. In addition, the National Council for Prescription Drug Programs (NCPDP) Telecommunication Standard D.0 was adopted by HHS for certain retail pharmacy transactions under the Health Insurance Portability and Accountability Act, as amended (HIPAA). Recently, HHS has proposed to adopt a modification to NCPDP D.0 by requiring the use of the “quantity prescribed” (460-ET) field for retail pharmacy transactions pertaining to Schedule II drugs. The modification is structured so that covered entities can distinguish whether a prescription is a partial fill or a refill in HIPAA retail pharmacy transactions. The modification also is intended to ensure that information is available to help prevent impermissible refills of Schedule II drugs. 84 Fed. Reg. 633, January 31, 2019. www.federalregister.gov/documents/2019/01/31/2019-00554/ administrative-simplification-modification-of-the-requirements-for-the-use-of-health-insurance. Accessed February 22, 2019.
- CMS. Medicare offers improved access to high-quality health coverage choices in 2018. www.cms.gov/newsroom/press-releases/medicare-offers-improved-access-high-quality-health-coverage-choices-2018. Accessed February 21, 2019. CMS. Part II of 2020 Advance Notice, pp. 135-136. Display measures published on CMS.gov are not part of the Star Ratings. The display measures may include measures that are transitioned from inclusion in the Star Ratings, new measures being tested before inclusion in the Star Ratings, or measures displayed solely for informational purposes. CMS, Part II of 2020 Advance Notice, p. 127. In addition, the National Committee for Quality Assurance is exploring the development of new measures assessing the use of non-opioid therapies (both pharmacologic and non-pharmacologic) for pain to manage care of patients with chronic pain. Id. at 140.
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