The 2019 Opioid Regulations

In October 2017, Acting Health and Human Services (HHS) Secretary Eric D. Hargan issued a statement declaring a nationwide public health emergency regarding the opioid crisis.¹ The opioid epidemic in America has become a top priority in efforts to prevent opioid overuse.

Opioids are a drug class that includes heroin, oxycodone, hydrocodone, codeine, morphine, fentanyl, and many other prescription pain relievers. These medications can carry serious risks, like addiction, overdose, and even death.

The U.S. Department of Health and Human Services (HHS) reported that more than 42,000 people died from overdoses involving opioids and estimated 40% of opioid overdose deaths involved a prescription opioid.²

New Medicare Part D Opioid Overutilization Policies

To help you use prescription opioid pain medications more safely, the Centers for Medicare and Medicaid Services (CMS) has recently introduced new regulations in the Medicare part D prescription drug program. Using recommendations made by Centers for Disease Control and Prevention (CDC) on prescribing opioids for pain, CMS developed new safety measures. Here are some key points that are crucial to understand:

1. New Opioid Users: Your Medicare drug plan and pharmacist will do safety reviews of your opioid pain medications when you fill a prescription. If you are a new opioid user, you may be limited to a 7 day supply or less. The hope is to reduce the risk of longer-term opioid misuse through closer management of opioid naïve patients.² This policy will affect Medicare patients who have not filled an opioid prescription within the past 60 days and will prevent pharmacies from filling a new opioid prescription exceeding a 7 days supply.²
2. Limited Opioid Amount: During the safety review, your pharmacist will also look for potentially unsafe opioid amounts and drug-drug interactions that may increase your risk of overdose. If your pharmacist decides that your total opioid prescription dose is not safe, the plan may limit your coverage of these drugs. This alert will identify patients that may benefit from closer monitoring and care coordination and encourage doctors to educate patients about opioid overdose risk and prevention.³
3. High-Risk Opioid Users: This new regulation allows Medicare drug plans to implement a drug management program (DMP) that limits access to opioids and benzodiazepines (used for anxiety and sleep) for patients at high risk of opioid abuse.³ High risk patients will need to obtain their opioids from specified doctors or pharmacies. Before Medicare places you in a DMP, it will notify you by letter. The goal of this program is to identify potential at-risk patients and provide better care coordination for safer use of opioids and benzodiazepines.³

Opioid Policy Exclusions

The new opioid regulations do not apply to patients with cancer, those who get hospice, palliative, or end-of-life care, or who live in a long-term care facility. Also, patients who use the medication-assisted treatment (MAT) program will not be impacted by these new policy changes.²

About 115 patients die every day from an opioid overdose. Because opioid addiction is driving this epidemic, the hope is that these new regulations will reduce the negative impacts of the epidemic on Americans.⁴ If you suffer from severe or long-term pain, talk with your doctor about all your pain treatment options including whether taking an opioid is appropriate for you. There may be other ways to manage your pain with less risks.

Resources:

1. HHS Acting Secretary Declares Public Health Emergency to Address National Opioid Crisis https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html
2. A Prescriber’s Guide to the New Medicare Part D Opioid Overutilization Polices for 2019. Centers for Medicare and Medicaid Services. https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/RxUtilization.html. Accessed January 20, 2019.
3. CY 2019 Final Call letter. Centers for Medicare and Medicaid Services. https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf. Accessed January 20, 2019.
4. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep. 2016;65:1-49, available at http://dx.doi.org/10.15585/mmwr.rr6501e1.