	CMS Delegated Monitoring of Beneficiaries who Receive Opioid Prescriptions to Plan Sponsors, but Did Not Have Sufficient Information on Those Most at Risk for Harm

		CMS Delegated Monitoring of Individual Beneficiaries’ Opioid Prescriptions to Plan Sponsors

Our October 2017 report found that CMS provided guidance to Medicare  Part D plan sponsors on how they should monitor opioid overutilization  problems among Part D beneficiaries. At the time of our review, the OMS  considered beneficiaries to be at a high risk of opioid overuse when they  met all three of the following criteria:  1.  received a total daily MED greater than 120 mg for 90 consecutive  2.  received opioid prescriptions from four or more health care providers  in the previous 12 months, and  3.  received opioids from four or more pharmacies in the previous 12  months. According to CMS officials, the agency also  expected plan sponsors to share any information with CMS on  beneficiaries that they identified through their own DUR systems. However, the agency  did not have comparable information on most beneficiaries who receive  high doses of opioids—regardless of the number of providers and  pharmacies used—and who therefore may be at risk for harm, according  to CDC’s 2016 guidelines. Based on the CDC guidelines, outreach to Part D plan sponsors, and  CMS analyses of Part D data, CMS has revised its current OMS criteria to  include more at-risk beneficiaries beginning in 2018. Based on 2015 data, CMS found that 33,223 beneficiaries would have  met these revised criteria. While the revised criteria would help identify  beneficiaries who CMS determined are at the highest risk of opioid  misuse and therefore may need case management by plan sponsors,  they did not provide information on the total number of Part D  beneficiaries who may be at risk of harm. 1.) Because neither the OMS criteria nor the  patient safety measures included all beneficiaries potentially at risk of  harm from high opioid doses, we recommended that CMS should gather  information over time on the total number of beneficiaries 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. HHS  concurred with our recommendation. CMS Oversees Providers through its Contractor and Plan Sponsors, but Efforts Did Not Specifically Monitor Opioid Prescriptions

Our October 2017 report found that CMS oversees providers who  prescribe opioids to Medicare Part D beneficiaries through its contractor,  NBI MEDIC, and the Part D plan sponsors. CMS  required NBI MEDIC to identify providers who prescribe high amounts  of Schedule II drugs, which include but are not limited to opioids. CMS’s guidance focused broadly on prescription drugs, and did not  specifically address opioids. CMS’s oversight actions focused broadly on Schedule  II drugs rather than specifically on opioids. As a result, we recommended that CMS require NBI MEDIC to  gather separate data on providers who prescribe high amounts of opioids. In addition, our 2017 report found that CMS also lacked key information  necessary for oversight of opioid prescribing, because it did not require  plan sponsors to report to NBI MEDIC or CMS cases of fraud, waste, and  abuse; cases of overprescribing; or any actions taken against providers. Plan sponsors collected information on cases of fraud, waste, and abuse,  and could choose to report this information to NBI MEDIC or CMS. In our report, we recommended that CMS require plan  sponsors to report on investigations and other actions taken related to  providers who prescribe high amounts of opioids. Conclusions

In conclusion, a large number of Medicare Part D beneficiaries use  potentially harmful levels of prescription opioids, and reducing the  inappropriate prescribing of these drugs has been a key part of CMS’s  strategy to decrease the risk of opioid use disorder, overdoses, and  deaths. Despite working to identify and decrease egregious opioid use  behavior—such as doctor shopping—among Medicare Part D  beneficiaries, CMS lacked the necessary information to effectively  determine the full number of beneficiaries at risk of harm, as well as other  information that could help CMS assess whether its efforts to reduce  opioid overprescribing are effective.
Why GAO Did This Study

Misuse of prescription opioids can lead to overdose and death. Medicare and Medicaid, two of the nation's largest health care programs, provide prescription drug coverage that can include opioids. GAO and others have reported on inappropriate activities and risks associated with these prescriptions.
This statement is based on GAO's October 2017 report (GAO-18-15) and discusses (1) CMS oversight of Medicare beneficiaries who receive opioid prescriptions under Part D, and (2) CMS oversight of providers who prescribe opioids to Medicare Part D beneficiaries. For the October 2017 report, 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

In October 2017, GAO found that the Centers for Medicare & Medicaid Services (CMS) provided guidance on the monitoring of Medicare beneficiaries who received opioid prescriptions to plan sponsors—private organizations that implement the Medicare drug benefit, Part D—but it lacked information on most beneficiaries at risk of harm from opioid use. Specifically, GAO found that
CMS provided guidance to plan sponsors on how they should monitor opioid overutilization among Medicare Part D beneficiaries, and required them to implement drug utilization review systems that use criteria similar to CMS's. Prior to 2018, the agency's criteria focused on beneficiaries who did all the following: (1) received prescriptions of high doses of opioids, (2) received prescriptions from four or more providers, and (3) filled prescriptions at four or more pharmacies. According to CMS, this approach focused actions on beneficiaries the agency determined to have the highest risk of harm. For 2018, CMS revised the criteria to include more at-risk beneficiaries.
CMS's criteria, including recent revisions, did not provide sufficient information about the larger population of potentially at-risk beneficiaries. CMS estimated that, in 2015, 727,016 beneficiaries would have received high doses of opioids regardless of the number of providers or pharmacies, but only 33,223 would have met its revised criteria. In 2016, CMS began to collect information on some of these beneficiaries using a higher dosage threshold for opioid use. However, based on Centers for Disease Control and Prevention guidelines, CMS's approach also missed some who could be at risk of harm. As a result, CMS had limited information to assess progress against the goals of the Medicare and Medicaid programs' Opioid Misuse Strategy, which includes activities to reduce risk of harm to beneficiaries.
CMS provided oversight on prescribing of drugs at high risk of abuse through a variety of projects, but did not analyze data specifically on opioids. According to CMS officials, CMS and plan sponsors identified providers who prescribed 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 did not identify providers who may be inappropriately prescribing large amounts of opioids separately from other drugs, and did not require plan sponsors to report actions they take when they identified such providers. As a result, CMS lacked 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

In the October 2017 report, GAO made three recommendations 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 and in this statement.