Responsibilities of Medicare Part D Plan Sponsors, CMS, and NBI MEDIC

Medicare Part D plan sponsors are private organizations, such as health  insurance companies and pharmacy benefit managers, contracted by  CMS to provide outpatient drug benefit plans to Medicare beneficiaries. In 2013,  CMS implemented the Medicare Part D opioid overutilization policy  intended to improve medication safety. CMS uses criteria in the OMS to identify high- risk use of opioids. CMS Delegates Monitoring of Beneficiaries who Receive Opioid Prescriptions to Plan Sponsors, but Does Not Have Sufficient Information on Most Beneficiaries at Risk for Harm CMS Delegates Monitoring of Individual Beneficiaries’ Opioid Prescriptions to Plan Sponsors

CMS provides guidance to plan sponsors on how they should monitor  opioid overutilization problems among Part D beneficiaries. 2. 3. CMS has goals to reduce the  risk of opioid use disorders, overdoses, inappropriate prescribing, and  drug diversion in its Opioid Misuse Strategy, but OMS does not track the  number of beneficiaries with prescriptions for high doses of opioids unless  those beneficiaries are also receiving them both from four or more  providers and from four or more pharmacies; and agency officials told us  that CMS has no plans for OMS to begin doing so. According to CMS officials, the revised OMS criteria, like the current  criteria, are intended to identify the beneficiaries it determined are at the  greatest risk of harm: those who may lack coordinated care as a result of  using multiple pharmacies and providers. While the revised criteria will help identify beneficiaries who CMS  determined are at the highest risk of opioid misuse and therefore may  need case management by plan sponsors, they will not provide  information on most Part D beneficiaries who may also be at risk of harm. CMS estimated that  33,223 beneficiaries would have met its revised criteria based on 2015  data, which is a much smaller number than the estimated 727,016  beneficiaries at risk of harm from opioids. 1.) CMS Oversees Providers through its Contractor and Plan Sponsors, but Efforts Do Not Specifically Monitor Opioid Prescriptions CMS’s Contractor and Plan Sponsors Seek to Identify Inappropriate Prescribing of Drugs with High Potential for Abuse, Including Opioids NBI MEDIC’s Data Analyses to Identify Outlier Providers

CMS oversees providers who prescribe opioids to Medicare Part D  beneficiaries through its contractor, NBI MEDIC, and the Part D plan  sponsors. CMS’s guidance focuses broadly  on prescription drugs, and does not specifically address opioids. Plan sponsors  collect information on cases of fraud, waste, and abuse, and can choose  to report this information to NBI MEDIC or CMS. Conclusions

A large number of Medicare Part D beneficiaries use prescription opioids,  and reducing the inappropriate prescribing of these drugs is a key part of  CMS’s strategy to decrease the risk of opioid use disorder, overdoses,  and deaths. CMS directs NBI MEDIC to focus its analyses on providers  who prescribe any drugs with a high risk of abuse, but NBI MEDIC does  not specifically track those providers who prescribe opioids. Absent  opioid-specific monitoring, CMS cannot assess whether its efforts to  reduce opioid overprescribing are effective, or if opioid prescribing  patterns are changing over time. The Administrator of CMS should gather information over time on the  number of beneficiaries at risk of harm from opioids, including those  who receive high opioid morphine equivalent doses regardless of the  number of pharmacies or providers, as part of assessing progress  over time in reaching the agency’s goals related to reducing opioid  use. (Recommendation 2)
The Administrator of CMS should require plan sponsors to report to  CMS on investigations and other actions taken related to providers  who prescribe high amounts of opioids. HHS did not concur with our recommendation that CMS require plan  sponsors to report on investigations and other actions taken related to  providers who prescribe high amounts of opioids. Due to the importance of this information, we continue to  believe that CMS should require plan sponsors to report on the  actions they take.
Why GAO Did This Study

Misuse of prescription opioids can lead to overdose and death. In 2016, over 14 million Medicare Part D beneficiaries received opioid prescriptions, and spending for opioids was almost $4.1 billion. GAO and others have reported on inappropriate activities and risks associated with these prescriptions, such as receiving multiple opioid prescriptions from different providers.
GAO was asked to describe what is known about CMS’s oversight of Medicare Part D opioid use and prescribing. This report examines (1) CMS oversight of beneficiaries who receive opioid prescriptions under Part D, and (2) CMS oversight of providers who prescribe opioids to Medicare Part D beneficiaries.GAO reviewed CMS opioid utilization and prescriber data, CMS guidance for plan sponsors, and CMS’s strategy to prevent opioid misuse. GAO also interviewed CMS officials, the six largest Part D plan sponsors, and 12 national associations selected to represent insurance plans, pharmacy benefit managers, physicians, patients, and regulatory and law enforcement authorities.

What GAO Found

The Centers for Medicare & Medicaid Services (CMS) provides guidance on the monitoring of Medicare beneficiaries who receive opioid prescriptions to plan sponsors—private organizations that implement the Medicare drug benefit, Part D—but lacks information on most beneficiaries at risk of harm.
CMS provides plan sponsors guidance on how they should monitor opioid overutilization among Medicare Part D beneficiaries and requires them to implement drug utilization review systems that use criteria similar to CMS's. CMS's criteria focus on beneficiaries who (1) receive prescriptions of high doses of opioids, (2) receive prescriptions from four or more providers, and (3) fill the prescriptions at four or more pharmacies. According to CMS officials, this approach allows plan sponsors to focus their actions on those beneficiaries it determined to have the highest risk of harm from opioid use.
CMS’s criteria, including recent revisions, do not provide sufficient information about the larger population of potentially at-risk beneficiaries. CMS estimates that while 33,223 beneficiaries would have met the revised criteria in 2015, 727,016 would have received high doses of opioids regardless of the number of providers or pharmacies. In 2016, CMS began to collect information on some of these beneficiaries using a higher dosage threshold for opioid use. This approach misses some who could be at risk of harm, based on Centers for Disease Control and Prevention guidelines. As a result, CMS is limited in its ability to assess progress toward meeting the broader goals of its Opioid Misuse Strategy, which includes activities to reduce the risk of harm from opioid use.
CMS Estimates of 2015 Part D Beneficiaries with High Opioid Doses and Those Who Would Have Met Revised Overutilization Monitoring Criteria
CMS oversees the prescribing of drugs at high risk of abuse through a variety of projects, but does not analyze data specifically on opioids. According to CMS officials, CMS and plan sponsors identify providers who prescribe large amounts of drugs with a high risk of abuse, and those suspected of fraud or abuse may be referred to law enforcement. However, GAO found that CMS does not identify providers who may be inappropriately prescribing large amounts of opioids separately from other drugs, and does not require plan sponsors to report actions they take when they identify such providers. As a result, CMS is lacking information that it could use to assess how opioid prescribing patterns are changing over time, and whether its efforts to reduce harm are effective.

What GAO Recommends

GAO recommends that CMS (1) gather information on the full number of at-risk beneficiaries receiving high doses of opioids, (2) identify providers who prescribe high amounts of opioids, and (3) require plan sponsors to report to CMS on actions related to providers who inappropriately prescribe opioids. HHS concurred with the first two recommendations, but not with the third. GAO continues to believe the recommendation is valid, as discussed in the report.