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. The agency includes  this guidance in its annual letters to plan sponsors, known as call letters;  it also provided a supplemental memo to plan sponsors in 2012. Among  other things, these guidance documents instructed plan sponsors to  implement a retrospective drug utilization review (DUR) system to monitor  beneficiary utilization starting in 2013. As part of the DUR systems,  CMS requires plan sponsors to have methods to identify beneficiaries  who are potentially overusing specific drugs or groups of drugs, including  opioids. Also in 2013, CMS created the Overutilization Monitoring System (OMS),  which outlines criteria to identify beneficiaries with high-risk use of opioids  and to oversee sponsors’ compliance with CMS’s opioid overutilization  policy. Plan sponsors may use the OMS criteria for their DUR systems,  but they have some flexibility to develop their own targeting criteria within  CMS guidance. 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. The criteria excluded beneficiaries with a cancer diagnosis and those in  hospice care, for whom higher doses of opioids may be appropriate. Through the OMS, CMS generates quarterly reports that list beneficiaries  who meet all of the criteria and who are identified as high-risk, and then  distributes the reports to the plan sponsors. Plan sponsors are expected  to review the list of identified beneficiaries, determine appropriate action,  and then respond to CMS with information on their actions within 30 days.  According to CMS officials, the agency also expects that plan sponsors  will share any information with CMS on beneficiaries that they identify  through their own DUR systems. We found that some actions plan  sponsors may take include Case management. Case management may include an attempt to  improve coordination issues, and often involves provider outreach,  whereby the plan sponsor will contact the providers associated with  the beneficiary to let them know that the beneficiary is receiving high  levels of opioids and may be at risk of harm. Beneficiary-specific point-of-sale (POS) edits. Beneficiary-specific  POS edits are restrictions that limit these beneficiaries to certain  opioids and amounts. Pharmacists receive a message when a  beneficiary attempts to fill a prescription that exceeds the limit in place  for that beneficiary. Formulary-level POS edits. These edits alert providers who may not  have been aware that their patients are receiving high levels of  opioids from other doctors. Referrals for investigation. According to the six plan sponsors we  interviewed, the referrals can be made to CMS’s National Benefit  Integrity Medicare Drug Integrity Contractor (NBI MEDIC), which is  responsible for identifying and investigating potential Part D fraud,  waste, and abuse, or to the plan sponsor’s own internal investigative  unit, if they have one. After investigating a particular case, they may  refer the case to the HHS-OIG or a law enforcement agency,  according to CMS, NBI MEDIC, and one plan sponsor. Based on CMS’s use of the OMS and the actions taken by plan sponsors,  CMS reported a 61 percent decrease from calendar years 2011 through  2016 in the number of beneficiaries meeting the OMS criteria of high  risk—from 29,404 to 11,594 beneficiaries—which agency officials  consider an indication of success toward its goal of decreasing opioid use  disorder. In addition, we found that CMS relies on separate patient safety  measures developed and maintained by the Pharmacy Quality Alliance to  assess how well Part D plan sponsors are monitoring beneficiaries and  taking appropriate actions. In 2016, CMS started tracking plan sponsors’  performance on three patient safety measures that are directly related to  opioids. The three measures are similar to the OMS criteria in that they  identify beneficiaries with high dosages of opioids (120 mg MED),  beneficiaries that use opioids from multiple providers and pharmacies,  and beneficiaries that do both. However, one difference between these  approaches is that the patient safety measures separately identify  beneficiaries who fulfill each criterion individually. 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. These guidelines note that long-term use of high doses of  opioids—those above a MED of 90 mg per day—are associated with  significant risk of harm and should be avoided if possible. 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. The new OMS  criteria define a high user as having an average daily MED greater than  90 mg for any duration, and who receives opioids from four or more  providers and four or more pharmacies, or from six or more providers  regardless of the number of pharmacies, for the prior 6 months. Based  on 2015 data, CMS found that 33,223 beneficiaries would have met these  revised criteria. 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, OMS will not  provide information on the total number of Part D beneficiaries who may  also be at risk of harm. In developing the revised criteria, CMS conducted  a one-time analysis that estimated there were 727,016 beneficiaries with  an average MED of 90 mg or more, for any length of time during a 6  month measurement period in 2015, regardless of the number of  providers or pharmacies used. 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.  However, CMS officials told us that the agency does not keep track of the  total number of these beneficiaries, and does not have plans to do so as  part of OMS. (See fig. 1.) We also found that in 2016, CMS began to gather information from its  patient safety measures on the number of beneficiaries who use more  than 120 mg MED of opioids for 90 days or longer, regardless of the  number of providers and pharmacies. The patient safety measures  identified 285,119 such beneficiaries—counted as member-years—in  2016. However, this information does not include all at-risk  beneficiaries, because the threshold is more lenient than indicated in  CDC guidelines and CMS’s new OMS criteria. 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. NBI MEDIC’s data analyses to identify outlier providers. CMS requires  NBI MEDIC to identify providers who prescribe high amounts of  Schedule II drugs, which include but are not limited to opioids. Using  prescription drug data, NBI MEDIC conducts a peer comparison of  providers’ prescribing practices to identify outlier providers—the  highest prescribers of Schedule II drugs. NBI MEDIC reports the  results to CMS. NBI MEDIC’s other projects. NBI MEDIC gathers and analyzes data  on Medicare Part C and Part D, including projects using the Predictive  Learning Analytics Tracking Outcome (PLATO) system. According  to NBI MEDIC officials, these PLATO projects seek to identify  potential fraud by examining data on provider behaviors. NBI MEDIC’s investigations to identify fraud, waste, and abuse. NBI  MEDIC officials conduct investigations to assist CMS in identifying  cases of potential fraud, waste, and abuse among providers for  Medicare Part C and Part D. The investigations are prompted by  complaints from plan sponsors; suspected fraud, waste, or abuse  reported to NBI MEDIC’s call center; NBI MEDIC’s analysis of outlier  providers; or from one of its other data analysis projects. NBI MEDIC’s referrals. After identifying providers engaged in potential  fraudulent overprescribing, NBI MEDIC officials said they may refer  cases to law enforcement agencies or the HHS-OIG for further  investigation and potential prosecution. Plan sponsors’ monitoring of providers. CMS requires all plan  sponsors to adopt and implement an effective compliance program,  which must include measures to prevent, detect, and correct Part C or  Part D program noncompliance, as well as fraud, waste, and abuse.  CMS’s guidance focuses broadly on prescription drugs, and does not  specifically address opioids. Our report concluded that although these efforts provide valuable  information, CMS lacks all the information necessary to adequately  oversee opioid prescribing. CMS’s oversight actions focus broadly on  Schedule II drugs rather than specifically on opioids. For example, NBI  MEDIC’s analyses to identify outlier providers do not indicate the extent to  which they may be overprescribing opioids specifically. According to CMS  officials, they direct NBI MEDIC to focus on Schedule II drugs, because  these drugs have a high potential for abuse, whether they are opioids or  other drugs. However, without specifically identifying opioids in these  analyses—or an alternate source of data—CMS lacks data on providers  who prescribe high amounts of opioids, and therefore cannot assess  progress toward meeting its goals related to reducing opioid use, which  would be consistent with federal internal control standards. Federal  internal control standards require agencies to conduct monitoring  activities and to use quality information to achieve objectives and address  risks. 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. HHS  agreed, and noted that it intends to work with NBI MEDIC to identify  trends in outlier prescribers of opioids. Our report also found that CMS also lacks key information necessary for  oversight of opioid prescribing, because it does 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 collect information on cases of fraud, waste, and abuse, and  can choose to report this information to NBI MEDIC or CMS. While CMS  receives information from plan sponsors who voluntarily report their  actions, it does not know the full extent to which plan sponsors have  identified providers who prescribe high amounts of opioids, or the full  extent to which sponsors have taken action to reduce overprescribing.  We concluded that without this information, it is difficult for CMS to assess  progress in this area, which would be consistent with federal internal  control standards. 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. HHS did not concur  with this recommendation. HHS noted that plan sponsors have the  responsibility to detect and prevent fraud, waste, and abuse, and that  CMS reviews cases when it conducts audits. HHS also stated that it  seeks to balance requirements on plan sponsors when considering new  regulatory requirements. However, without complete reporting—such as  reporting from all plan sponsors on the actions they take to reduce  overprescribing—we believe that CMS is missing key information that  could help assess progress in this area. 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. Despite  working to identify and decrease egregious opioid use behavior—such as  doctor shopping—among Medicare Part D beneficiaries, CMS lacks 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. It is important that health care providers help patients to receive  appropriate pain treatment, including opioids, based on the consideration  of benefits and risks. Access to information on the risks that Medicare  patients face from inappropriate or poorly monitored prescriptions, as well  as information on providers who may be inappropriately prescribing  opioids, could help CMS as it works to improve care. Chairman Jenkins, Ranking Member Lewis, and Members of the  Subcommittee, this concludes my prepared statement. I would be  pleased to respond to any questions that you may have at this time. GAO Contacts and  Staff  Acknowledgements If you or your staff members have any questions concerning this  testimony, please contact me at (202) 512-7114 or CurdaE@gao.gov.  Contact points for our Office of Congressional Relations and Public  Affairs may be found on the last page of this statement. Other individuals  who made key contributions to this testimony include Will Simerl  (Assistant Director), Carolyn Feis Korman (Analyst-in-Charge), Amy  Andresen, Drew Long, Samantha Pawlak, Vikki Porter, and Emily Wilson. This is a work of the U.S. government and is not subject to copyright protection in the  United States. The published product may be reproduced and distributed in its entirety  without further permission from GAO. However, because this work may contain  copyrighted images or other material, permission from the copyright holder may be  necessary if you wish to reproduce this material separately.
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. 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.