CMS Issues New Regulations Aimed at Identifying and Limiting Potential Opioid Abuse

By Sidney Wong  |  April 12, 2018

On April 2, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a final rule which updated regulations for Medicare Advantage Plans (MAP) and Medicare Part D programs. The primary focus of the updates is to provide to MAP and Part D plans additional guidelines and tools to target the nation’s growing opioid epidemic.

These new regulations expand Medicare’s ability to identify medication misuse and establish point of sale controls. For example, on or after January 1, 2019, Part D plans will be empowered through the Comprehensive Addiction and Recovery Act (CARA) to establish drug management programs for beneficiaries at risk of abusing medications. Part of the framework provided in the final rule guides the Part D plan sponsors to analyze specific triggers, such as medication dosage or multiple prescribers to identify misuse. Once misuse is determined, Part D plans can designate an individual as an “at risk” beneficiary and limit or “lock in” the beneficiary’s access to frequently abused drugs to specific providers and pharmacies. The existing Part D overutilization guidelines and monitoring system will be codified and integrated into the drug utilization program provisions.

As part of this initiative, CMS indicated that it intends to designate all opioids, except Buprenorphine for medication assisted treatment, on the list of frequency abused drugs. Furthermore, benzodiazepines will also be designated as a frequently abused drug based on its concurrent use with opioids, but it will remain excluded from the 2019 clinical guidelines. Going forward, Medicare will keep and publish an updated list of frequently abused drugs for the Part D drug management programs.

It is too early to tell whether and how these new regulations may affect CMS’ methodology for calculating and approving prescription treatment in a Workers’ Compensation Medicare Set-Aside (WCMSA). Currently, CMS’ standard policy is to include all indicated Medicare covered medication priced at the most recent dosage and frequency for the full life expectancy of an individual. Notably, other attempts by the Federal government to address the opioid epidemic, such as the 2016 release of the Centers for Disease Control and Prevention’s (CDC) opioid guidelines, have not influenced CMS’ WCMSA prescription policy. Hopefully, since the new regulations require Part D programs to consider medication overutilization and abuse as part of its coverage and drug management programs, CMS will also factor in similar considerations when calculating and approving future treatment in a WCMSA.

ISO Claims Partners will continue to monitor these regulations as they are implemented and what impact they may have regarding WCMSAs.

If you have any questions regarding WCMSAs or the present topic please do not hesitate to contact Sid Wong, assistant vice president of Policy via phone at 978.825.8262 or via e-mail Sidney.Wong@verisk.com.


Sidney Wong

Sidney Wong is the assistant vice president of policy at ISO Claims Partners, where he provides the highest level of client services—with a focus on meeting the needs of clients through ISO’s products and services. He is also responsible for assisting clients with effectively navigating Medicare compliance issues.