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

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

Our October 2017 report found that CMS provides guidance to Medicare  Part D plan sponsors on how the plan sponsors 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 providers in the  previous 12 months, and  3.  received opioids from four or more pharmacies in the previous 12  months. CMS Does Not Have Sufficient Information on Most Beneficiaries Potentially at Risk for Harm

Our October 2017 report also found that while CMS tracks the total  number of beneficiaries who meet all three OMS criteria as part of its  opioid overutilization oversight across the Part D program, it does 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  guidelines. Based  on 2015 data, CMS found that 33,223 beneficiaries would have met these  revised criteria. These beneficiaries may be at risk of harm  from opioids, according to CDC guidelines, and therefore tracking the  total number of these beneficiaries over time could help CMS to  determine whether it is making progress toward meeting the goals  specified in its Opioid Misuse Strategy to reduce the risk of opioid use  disorders, overdoses, inappropriate prescribing, and drug diversion. 1.) Because neither the OMS  criteria nor the patient safety measures include 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 Do 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 requires  NBI MEDIC to identify providers who prescribe high amounts of  Schedule II drugs, which include but are not limited to opioids. CMS’s guidance focuses broadly on prescription drugs, and does not  specifically address opioids. CMS’s oversight actions focus 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. This would allow CMS to better identify those providers who are  inappropriately and potentially fraudulently overprescribing opioids. Plan  sponsors collect information on cases of fraud, waste, and abuse, and  can 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. Due to the importance of this  information for achieving the agency’s goals, we continue to believe that  CMS should require plan sponsors to report on the actions they take to  reduce overprescribing. - - - - -  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 is a key part of CMS’s strategy to  decrease the risk of opioid use disorder, overdoses, and deaths.
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.
This statement is based on GAO's October 2017 report (GAO-18-15) and discusses (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. 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

The Centers for Medicare & Medicaid Services (CMS), within the Department of Health and Human Services (HHS), 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 from opioid use.
CMS provides guidance to plan sponsors 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 focused on beneficiaries who do all the following: (1) receive prescriptions of high doses of opioids, (2) receive prescriptions from four or more providers, and (3) fill 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.
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 for the Medicare and Medicaid programs, which includes activities to reduce the risk of harm to beneficiaries from opioid use.
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

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.