PRESCRIPTION OPIOIDS

Medicare Should Expand 

Oversight Efforts to 

Reduce the Risk of Harm

Statement of Elizabeth H. Curda, Director, Health Care

Testimony 

Before the Subcommittee on Oversight, 

Committee on Ways and Means, House 

of Representatives

For Release on Delivery 

Expected at 10:00 a.m. ET

Wednesday, January 17, 2018

GAO-18-336T

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-18-336T, a testimony 

before the Subcommittee on Oversight, 

Committee on Ways and Means, House of 

Representatives

January 17, 2018

PRESCRIPTION OPIOIDS

Medicare Should Expand Oversight Efforts to Reduce 

the Risk of Harm

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 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.

View GAO-18-336T. For more information, 

contact Elizabeth H. Curda at (202) 512-7114 

or curdae@gao.gov.

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 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.
Letter

Page 1 GAO-18-336T 

Chairman Jenkins, Ranking Member Lewis, and Members of the 

Subcommittee:

I am pleased to be here to discuss our recently released report on 

oversight of opioid prescribing in the Medicare program.1 Misuse of 

prescription opioids, which are used to treat both acute and chronic pain, 

has become a serious public health problem for the U.S. population, 

including Medicare beneficiaries. The Centers for Disease Control and 

Prevention (CDC) reported that from 1999 to 2013 the rate of drug 

poisoning deaths from prescription opioids nearly quadrupled from 1.4 to 

5.1 per 100,000 people.2 In addition, the Department of Health and 

Human Services (HHS) Office of Inspector General (HHS-OIG) reported 

that 14.4 million people (about one-third) who participate in Medicare Part 

D received at least one prescription for opioids in 2016, and that Part D 

spending for opioids in 2016 was almost $4.1 billion.3 GAO and the HHSOIG have previously reported on inappropriate activities that can be 

associated with such prescriptions, including “doctor shopping” to receive 

multiple opioid prescriptions from different providers; the diversion of 

prescription drugs for uses other than what was intended; and 

questionable prescribing practices by providers, including those in 

Medicare.4

 1

See GAO, Prescription Opioids: Medicare Needs to Expand Oversight Efforts to Reduce 

the Risk of Harm, GAO-18-15 (Washington, D.C.: Oct. 6, 2017).

2

Department of Health and Human Services, Centers for Disease Control and Prevention, 

Rates of Deaths from Drug Poisoning and Drug Poisoning Involving Opioid Analgesics—

United States, 1999-2013, Morbidity and Mortality Weekly Report, vol. 64, no. 1, (Atlanta, 

Ga.: Jan. 16, 2015).

3

Department of Health and Human Services Office of Inspector General, Opioids in 

Medicare Part D: Concerns about Extreme Use and Questionable Prescribing, OE-02-17-

00250 (July 2017). Medicare is a federal health insurance program for people age 65 and 

older, individuals under age 65 with certain disabilities, and individuals diagnosed with 

end-stage renal disease. Since 2006, Medicare Part D has offered voluntary prescription 

drug coverage through stand-alone prescription drug plans or through Medicare 

Advantage prescription drug plans, which combine medical and prescription drug benefits.

4

See GAO, Medicare Part D: Instances of Questionable Access to Prescription Drugs, 

GAO-11-699 (Washington, D.C.: Sept. 6, 2011); and Medicare Program Integrity: CMS 

Pursues Many Practices to Address Prescription Drug Fraud, Waste, and Abuse, 

GAO-15-66 (Washington, D.C.: Oct. 24, 2014). See also Department of Health and 

Human Services, Office of Inspector General, High Part D Spending on Opioids and 

Substantial Growth in Compounded Drugs Raise Concerns, OEI-02-16-0029 (June 2016).

Letter
Page 2 GAO-18-336T 

In March 2015, HHS announced plans to make addressing opioid abuse 

a high priority through two broad goals: (1) decreasing opioid overdoses 

and overall overdose deaths, and (2) decreasing the prevalence of opioid 

use disorder.5 In 2016, CDC issued guidelines with recommendations for 

prescribing opioids in outpatient settings for chronic pain. 6 The guidelines 

recommended that providers use caution when prescribing opioids at any 

dose, carefully reassess evidence of individual benefits and risks when 

increasing opioid dosage to 50 mg morphine-equivalent dose (MED) per 

day or more, and either avoid or carefully justify dosage at 90 mg MED or 

more. CDC guidelines also noted that providers should use additional 

caution in prescribing opioids to patients aged 65 and older, because the 

drugs can accumulate in the body to toxic levels. Further, in January 

2017, the Centers for Medicare & Medicaid Services (CMS), the HHS 

agency that administers Medicare, issued its Opioid Misuse Strategy for 

the Medicaid and Medicare programs, including Medicare Part D.7 The 

strategy includes the agency’s plans to address concerns about 

beneficiary use of opioids and the prescribing of opioids by providers.

My remarks today discuss the findings and recommendations from our 

report on CMS efforts to oversee prescription opioids.8 Accordingly, this 

testimony focuses on (1) how CMS oversees beneficiaries who receive 

opioid prescriptions under Medicare Part D, and (2) how CMS oversees 

providers who prescribe opioids to Medicare Part D beneficiaries. For our 

report, we reviewed CMS opioid utilization and prescriber data, CMS 

guidance for plan sponsors, and CMS’s strategy to prevent opioid misuse. 

We also interviewed officials from CMS, the six largest Part D plan 

sponsors—private organizations, such as health insurance companies, 

 5

Department of Health and Human Services, Office of the Assistant Secretary for Planning 

and Evaluation, Opioid Abuse in the U.S. and HHS Actions to Address Opioid-Drug 

Related Overdoses and Death (Mar. 26, 2015). Opioid use disorder is defined as a 

problematic pattern of opioid use leading to clinically significant impairment or distress as 

indicated by at least 2 of 11 criteria occurring within a 12 month period. The criteria 

include taking opioids in larger amounts or over a longer period of time than was intended, 

persistent desire or unsuccessful efforts to cut down or control opioid use, or a strong 

desire or urge to use opioids. 

6

Department of Health and Human Services, Centers for Disease Control and Prevention, 

CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016, Morbidity 

and Mortality Weekly Report, vol. 65, no. 1, (Atlanta, Ga.: Mar. 18, 2016).

7

Centers for Medicare & Medicaid Services, Centers for Medicare & Medicaid Services 

(CMS) Opioid Misuse Strategy 2016 (Jan. 5, 2017).

8

See GAO-18-15.
Page 3 GAO-18-336T 

contracted by CMS to provide outpatient drug benefit plans to Medicare 

beneficiaries—and 12 national associations selected to represent 

insurance plans, pharmacy benefit managers, physicians, patients, and 

regulatory and law enforcement agencies. More detailed information on 

our objectives, scope, and methodology for that work can be found in the 

issued report. We conducted the work on which this statement is based in 

accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.

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
Page 4 GAO-18-336T 

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 2012.9 Among 

other things, these guidance documents instructed plan sponsors to 

implement a retrospective drug utilization review (DUR) system to monitor 

beneficiary utilization starting in 2013.10 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 

days,

2. received opioid prescriptions from four or more providers in the 

previous 12 months, and

 9

Centers for Medicare & Medicaid Services, Announcement of Calendar Year (CY) 2013 

Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment 

Policies and Final Call Letter, accessed December 21, 2016, 

https://www.cms.gov/Medicare/Health-Plans/HealthPlansGenInfo/Downloads/2013-CallLetter.pdf; and Centers for Medicare & Medicaid Services, Supplemental Guidance 

Related to Improving Drug Utilization Review Controls in Part D, accessed April 25, 2017, 

https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/HPMSSupplementalGuidanceRelatedtoImprovingDURcontrols.pdf.

10In addition to instructing plan sponsors to implement retrospective DUR systems, the 

guidance in the 2013 call letter includes information on other mechanisms to control 

overutilization. See https://www.cms.gov/Medicare/HealthPlans/HealthPlansGenInfo/Downloads/2013-Call-Letter.pdf. 

CMS Delegates 

Monitoring of Individual 

Beneficiaries’ Opioid 

Prescriptions to Plan 

Sponsors
Page 5 GAO-18-336T 

3. received opioids from four or more pharmacies in the previous 12 

months.11

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 

 11These criteria are in effect through 2017. CMS announced in its April 3, 2017 call letter 

the revisions to the OMS criteria that will take effect in 2018. See Announcement of 

Calendar Year (CY) 2018 Medicare Advantage Capitation Rates and Medicare Advantage 

and Part D Payment Policies and Final Call Letter and Request for Information, accessed 

April 4, 2017. https://www.cms.gov/Medicare/HealthPlans/MedicareAdvtgSpecRateStats/Downloads/Announcement2018.pdf. Some of the 

beneficiaries that meet the OMS criteria may not be using the opioids themselves, but 

rather diverting them by either giving or selling them to others.
Page 6 GAO-18-336T 

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.12 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.

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 

 12The Pharmacy Quality Alliance is a consensus-based, multi-stakeholder membership 

organization that collaboratively promotes appropriate medication use and develops 

strategies for measuring and reporting performance information related to medications. 

The alliance developed all but one of CMS’s Part D patient safety measures, and that one 

measure is not related to opioid safety. 

CMS Does Not Have 

Sufficient Information on 

Most Beneficiaries 

Potentially at Risk for 

Harm
Page 7 GAO-18-336T 

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.13 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.)

Figure 1: CMS Estimates of 2015 Part D Beneficiaries with High Opioid Doses and 

Those Who Would Have Met Revised Overutilization Monitoring Criteria

a

This number includes beneficiaries with an average opioid morphine equivalent dose of 90 

milligrams or more within a 6-month measurement period.

b

This number is an estimate of how many beneficiaries would have met CMS’s revised Overutilization 

Monitoring System (OMS) criteria. CMS calculated these totals by applying the revised OMS criteria 

to 2015 Part D data.

 13According to CMS officials, the changes are partially in response to CDC’s 2016 

guidelines. The CDC guidelines noted that patients are at risk of harm above 50 mg MED 

and that providers should generally avoid increasing dosage to more than 90 mg MED of 

opioids, regardless the number of providers or pharmacies.
Page 8 GAO-18-336T 

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 

2016.14 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.

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.15 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.16 According 

to NBI MEDIC officials, these PLATO projects seek to identify 

potential fraud by examining data on provider behaviors.

 14Patient safety measures count member-years, which account for beneficiaries who are 

enrolled in a Part D plan for only part of a year.

15Under the Controlled Substances Act, which was enacted in 1970, drugs are classified 

as controlled substances and placed into one of five schedules based on their medicinal 

value, potential for abuse, and risk of dependence. Schedule II drugs have the highest 

potential for abuse of any drugs approved for medical use. 

16Medicare Part C, also known as Medicare Advantage, is a private plan alternative to 

traditional Medicare, and covers all traditional Medicare services.

CMS Oversees 

Providers through its 

Contractor and Plan 

Sponsors, but Efforts 

Do Not Specifically 

Monitor Opioid 

Prescriptions
Page 9 GAO-18-336T 

• 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.17 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 

 17GAO, Standards for Internal Control in the Federal Government, GAO-14-704G 

(Washington, D.C.: Sept. 10, 2014). Internal controls is a process affected by an entity’s 

oversight body, management, and other personnel that provides reasonable assurance 

that the objectives of an entity will be achieved. 
Page 10 GAO-18-336T 

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.18 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 

 18According to CMS officials, the agency’s regulations currently make reporting 

inappropriate prescribing and any actions against providers voluntary for plan sponsors. 

See 42 C.F.R. § 423.504(b)(4)(vi)(G)(3).
Page 11 GAO-18-336T 

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.

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.

GAO Contacts and 

Staff 

Acknowledgements

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