Dear Health Care Provider:

Thank you for your participation in Medicare and the services you and your colleagues provide to more than 55 million people with Medicare. You are integral to our work at the Centers for Medicare & Medicaid Services (CMS) to combat the opioid epidemic.

We recently published an opioids roadmap at https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Opioid-epidemic-roadmap.pdf outlining our efforts to address this issue of national concern. In this roadmap, we detail our three-pronged approach, focusing in on preventing new cases of opioid use disorder, treating patients who have opioid use disorders, and using data from across the country to target prevention and treatment activities.

CMS is working with the U.S. Department of Health and Human Services (HHS) to encourage health care providers to co-prescribe naloxone to certain at-risk patients who use opioids. We are also strengthening Medicare drug plan policies to promote care coordination and safe use of prescription opioids, and encouraging health care providers to promote a range of safe and effective pain treatments, including courses of action other than opioids.

Co-prescribing Naloxone

HHS issued guidance at https://www.hhs.gov/opioids/sites/default/files/2018-12/naloxone-coprescribing-guidance.pdf and recommended a set of indications for naloxone prescriptions. As a provider, you can have important conversations with your patients about pain management, and opioid safety. You can help expand naloxone access and awareness by co-prescribing naloxone for certain patients who get opioids for pain management and who may be at-risk for an opioid overdose. In concert with standing pharmacy orders, pharmacist prescriptive authority, and other naloxone laws, regulations and policies, your action can help ensure your high-risk patients have naloxone more readily available to them, and, when needed, to their families and caregivers.

New Medicare Part D Opioid Policies

CMS recently finalized new policies for Medicare drug plans, effective January 1, 2019. The policies broaden our partnership with providers to address the opioid crisis while maintaining access to needed medications. It’s very important you understand the new policies to minimize additional burden on you and your patients. It is also critical in avoiding adverse and unintended impacts on your patients’ access to prescribed opioids.

Our approach centers on increasing communication tools to improve safety, especially as we process opioid prescriptions. The new policies include improved safety alerts (pharmacy claim edits) when a patient fills an opioid prescription at a pharmacy, and drug management programs to help coordinate care for patients with high-risk opioid use, such as those receiving high levels of opioids from multiple prescribers and/or pharmacies.

Detailed training materials about these new policies are available:

• A Prescriber’s Guide to the New Medicare Part D Opioid Overutilization Policies for 2019: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE18016.pdf.

• Information for Prescribers, such as slide deck and tip sheet: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/RxUtilization.html

Starting January 1, 2019, Medicare drug plans will employ the following safety alerts at the pharmacy:

• 7 day supply limit for opioid naïve patients: This is a policy to limit an initial opioid prescription supply to 7 days or less until the pharmacy gets an override from the plan for Medicare patients who have not recently filled an opioid prescription (e.g., within 60 days). The pharmacist can fill part of the initial prescription (e.g., a 7 day supply) per state and federal regulations. If a prescriber writes another prescription for the remainder of the days-supply, or any subsequent prescriptions, those prescriptions are not subject to the 7 day supply limit because the patient is no longer considered opioid naïve.

However, if a prescriber believes that an opioid naïve patient will initially need more than a 7 day supply initially, the prescriber can contact the plan to request a coverage determination on behalf of the patient attesting to the medical need for a supply greater than 7 days. The prescriber can also request an expedited or standard coverage determination in advance of prescribing an opioid.

• Opioid care coordination alert: This is an alert for pharmacists to review when the patient’s cumulative morphine milligram equivalents (MME) reaches 90 mg or greater per day across all opioid prescriptions. Some plans use this alert only when the patient uses multiple opioid prescribers and/or opioid dispensing pharmacies.

This 90 MME threshold identifies potentially high risk patients who may benefit from closer monitoring and care coordination. It is cited in the Centers for Disease Control and Prevention (CDC) Guideline (https://www.cdc.gov/drugoverdose/prescribing/guideline.html) as the level above which primary care prescribers should generally avoid. This is not a prescribing limit. In reviewing the alert, the pharmacist may contact the prescriber to confirm medical need for the higher MME. The pharmacist may talk with the prescriber about other opioid prescribers or increasing level (MME) of opioids. After that discussion to confirm intent, the pharmacist can fill the prescription.

The prescriber who writes the prescription will trigger the alert and a pharmacist will contact the prescriber even if that prescription itself is below the 90 MME threshold. Once a pharmacist consults with a prescriber on a patient’s prescription for a plan year, the prescriber will not be contacted on every opioid prescription written for the same patient after that unless the plan implements further restrictions.

The new CMS policies also include drug management programs to encourage care coordination and safe use of opioids as required by the Comprehensive Addiction and Recovery Act of 2016. Starting in 2019, for patients who could potentially abuse or misuse prescription drugs - including opioids and benzodiazepines - a Medicare drug plan will contact prescribers through case management to review patients’ total utilization pattern of frequently abused drugs and discuss the following coverage limitation tools:

• Requiring the patient to get these medications from a specified prescriber and/or pharmacy, or

• Implementing an individualized point of sale edit that limits the amount the drug plan covers for these medications.

Medicare drug plans identify potential at-risk patients by their opioid use which involve multiple doctors and pharmacies. After the plan conducts case management with prescribers and before implementing any coverage limitation tools, the Medicare plan will notify your patients in writing. Plans must make reasonable efforts to send the prescriber a copy of the letter.

Prescribers and patients can respond to the notice within 30 days. After this 30 day time period, if the plan determines based on its review that the patient is at-risk and implements a limitation, the plan must send the patient a second written notice confirming the specific limitation and its duration.

If the plan decides to limit coverage under a drug management program, the patient and their prescriber have the right to appeal the plan’s decision. The patient or prescriber should contact the plan for additional information on how to appeal.

Promoting a range of safe and effective pain treatments

Opioids are one tool to help your patients with chronic pain. You may also want to consider other treatments when you discuss options with your patients. Medicare covers a variety of services to treat pain. Medicare covers some services across the country, including physical therapy, individual and group therapy, behavioral health integration services, psychiatric collaborative care services and electrical nerve stimulation. Local coverage of additional services may vary somewhat by jurisdiction; you can find detailed information, related coding information, and any restrictions on our website at https://www.cms.gov/medicare-coverage-database/indexes/national-and-local-indexes.aspx along with a searchable database https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx.

• Medicare also covers care management services to give patients medical care and care coordination services that can help manage their medical condition(s). Information about Chronic Care Management, Behavioral Health Integration, and Transitional Care Management at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.

• Medicare’s Initial Preventive Physical Exam and subsequent Annual Wellness Visits give you other opportunities to discuss your patients’ general health issues including pain, and review and promote options for pain treatment. See more information about coverage of these services at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE18004.pdf.

• There are community programs to help your Medicare patients manage their pain and other chronic conditions. Find out how to access these programs through Area Agencies on Aging and other community-based organizations at: https://eldercare.acl.gov/Public/Index.aspx.

• CMS has dedicated quality improvement contractors to work with you and community organizations to improve health care safety and reduce opioid related adverse events in every state with the Quality Innovation Network Quality Improvement Organizations (QIN-QIOs https://qioprogram.org/locate-your-qio) , and the Hospital Improvement and Innovation Network (HII https://partnershipforpatients.cms.gov/wherepartnershipsareinaction/wherepartnershipsareinaction.html #HIIN).

CMS is committed to exploring and offering viable options to address the opioid crisis, sharing information on the data we collect with other agencies and organizations, and protecting our beneficiaries and communities affected by the crisis. Together, we can make progress in addressing many aspects of the opioid epidemic. For questions on CMS opioid policies, please see our available resources at: https://www.cms.gov/about-cms/story-page/opioid-misuse-resources.html#provider.