HHS OIG Data Brief    May 2020    OEI-02-19-00130 
 
Medicare Part D Beneficiaries at Serious Risk of  
Opioid Misuse or Overdose:  A Closer Look  
 
Why OIG Did This Review 
As the Nation continues to struggle with the opioid crisis, it is vital to gain a deeper understanding of 
those who are at risk of misuse or overdose.  The 2020 COVID-19 pandemic makes the need to look at this 
population even more pressing.  The National Institutes of Health recently issued a warning that individuals 
with opioid use disorder could be particularly hard hit by COVID-19, as it is a disease that attacks the lungs.  
Respiratory disease is known to increase the mortality risk among people taking opioids.1   
The Office of Inspector General (OIG) has been tracking opioid use in Medicare Part D throughout the 
opioid crisis.2  OIG identified 71,260 Part D beneficiaries at serious risk of misuse or overdose in 2017; each 
of these beneficiaries received extreme amounts of opioids or appeared to be doctor shopping.  This data 
brief provides a deeper understanding of these beneficiaries by examining their Medicare claims from 2017 
and 2018 and determining the following: their opioid amounts; the extent to which they had opioid 
overdoses; the extent to which they received naloxone through Medicare Part D; and the extent to which 
they have a diagnosis of opioid use disorder and received drugs for medication-assisted treatment (MAT 
drugs) through Part D.  This information is critical to helping the Department of Health and Human 
Services (HHS) target its efforts to combat the opioid crisis. 
What OIG Found 
  Most Part D beneficiaries at serious risk of opioid misuse or overdose in 2017 received high 
amounts of opioids the following year. 
  Fewer beneficiaries at serious risk in 2017 received extreme amounts of opioids or appeared to be 
doctor shopping the following year. 
  Eleven percent of beneficiaries at serious risk in 2017 had an overdose or adverse effect from 
an opioid in 2017 or 2018. 
  About one-quarter of beneficiaries at serious risk in 2017 received a prescription through Part D 
for naloxone, a drug that reverses opioid overdoses. 
  About half of beneficiaries at serious risk in 2017 have been diagnosed with opioid use disorder or 
other conditions related to the misuse of opioids.  
  Only 7 percent of beneficiaries at serious risk in 2017 who were diagnosed with opioid use disorder 
received MAT drugs through Part D, possibly because of challenges that beneficiaries have in 
accessing prescribers.  
See primer on page 3 for definitions of extreme amounts, high amounts, and doctor shopping. 
  What OIG Recommends 
Although opioids can be appropriate under certain circumstances, steps should be taken to mitigate the 
risk of misuse and overdose, especially when beneficiaries receive high amounts of opioids for long 
periods of time.  This data brief also demonstrates that opportunities exist for the Centers for Medicare & 
Medicaid Services (CMS) to expand its role in ensuring that beneficiaries receive treatment for opioid use 
disorder.  Although CMS is taking some significant steps, we recommend that CMS educate Part D 
beneficiaries and providers about access to MAT drugs and naloxone.  CMS concurred with our 
recommendation. 
 
       
Primer:  Beneficiaries at Serious Risk of Opioid Misuse or 
Overdose  
 
Which beneficiaries were at serious risk of opioid misuse or overdose in 
2017? 
  Those who: 
o  received extreme amounts of opioidsi.e., an average daily morphine equivalent dose* 
greater than 240 mg for 12 months during the year, or 
o  appeared to be doctor shoppingi.e., received high amounts of opioids (an average 
daily morphine equivalent dose greater than 120 mg for 3 months) and had four or more 
prescribers and four or more pharmacies during the year. 
How many beneficiaries were at serious risk in 2017?  
  71,260 beneficiaries were at serious risk in 2017.  They included:   
o  57,611 beneficiaries who received extreme amounts of opioids, and 
o  14,814 beneficiaries who appeared to be doctor shopping.** 
What are the characteristics of beneficiaries at serious risk in 2017?  
  Almost three-quarters of these beneficiaries were under the age of 65 years; many qualified 
for Medicare because they were disabled.   
  The vast majority of these beneficiaries were diagnosed with chronic pain or back pain. 
  Most also had one or more common chronic diseases or conditions, such as hypertension, 
high cholesterol, or gastroesophageal reflux disease.***   
  About two-thirds have a diagnosis related to anxiety or depression.  
  These beneficiaries are located throughout the Nation.   
 
* For an explanation of morphine equivalent dose (MED), see page 4 of this data brief. 
** In total, 1,165 beneficiaries were identified as being in both serious-risk groups in 2017.  Other Part D beneficiaries may 
also be at serious risk but do not fall into either of these groups. 
*** See Appendix A for more information about the most common diagnoses among beneficiaries at serious risk. 
 
Source:  OIG analysis of 2017 and 2018 prescription drug event records and Medicare claims, 2018 and 2019.      
RESULTS 
Four out of every five Part D beneficiaries who were at serious risk of opioid 
Most Part D 
misuse or overdose in 2017 received high amounts of opioids the following 
beneficiaries at 
year.  A total of 71,260 beneficiaries were at serious risk of opioid misuse or 
serious risk in 2017  overdose in 2017 because they received extreme amounts of opioids or 
appeared to be doctor shopping (i.e., receiving high amounts of opioids in 
received high 
addition to having four or more prescribers and four or more pharmacies).  
amounts of 
Most of these beneficiaries57,604 of 71,260also received high amounts 
opioids the  of opioids in 2018.  None of these 57,604 beneficiaries had a diagnosis of 
following year  cancer or were in hospice care.  
Each of these 57,604 beneficiaries received a high amount of opioids 
through Part D in 2018, i.e., they had an average daily morphine equivalent 
dose (MED) that exceeded 120 mg for at least 3 months during the year.  
MEDwhich is also known as morphine milligram equivalent (MME)is a 
measure that converts all the various opioids and strengths into one 
standard value.  A daily MED of 120 mg is equivalent to taking 12 tablets a 
day of Vicodin 10 mg or 16 tablets a day of Percocet 5 mg.   
Most of these beneficiaries (46,472) had opioid amounts that were twice 
that high.  These beneficiaries had an average daily MED that exceeded 
240 mg for at least 3 months during 2018.  This is equivalent to receiving 
32 tablets of Percocet 5 mg every day for 3 months.   
Although beneficiaries may receive opioids for legitimate purposes, 
receiving high amounts of opioids in multiple years raises concerns.  The 
Centers for Disease Control and Prevention (CDC) has published a guideline 
on prescribing opioids to patients with chronic pain.  This guideline 
recommends that prescribers use caution when ordering opioids at any 
dosage and avoid increasing dosages to the equivalent of 90 mg or more 
MED a day.3  For patients who are already taking high dosages of opioids, 
prescribers should offer the patients the opportunity to re-evaluate their 
continued use of these dosages, and prescribers should offer to work with 
them to taper their opioids to safer dosages.4   HHS recently issued a guide 
for clinicians on how to appropriately reduce or discontinue long-term use 
of opioids.5  The guide emphasizes that prescribers should decide based on 
the patients individual circumstances whether tapering is appropriate.    
   
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Fewer beneficiaries  Of the 71,260 beneficiaries at serious risk in 2017, a total of 57,611 received 
extreme amounts of opioids for the entire year of 2017.  This number 
at serious risk in 
decreased the following year, with 27,137 of the beneficiaries at serious risk 
2017 received 
in 2017 receiving extreme amounts of opioids for the entire year of 2018.  
extreme amounts  These beneficiaries each had an average daily MED of greater than 240 mg 
of opioids or  for all of 2018.  None of them had a diagnosis of cancer or were in hospice 
care.   
appeared to be 
doctor shopping  The number of beneficiaries who appeared to be doctor shopping 
decreased to a greater extent.  A total of 14,814 beneficiaries at serious risk 
the following year 
in 2017 appeared to be doctor shopping that year, meaning that in 2017 
they each received a high amount of opioids in addition to having four or 
more prescribers and four or more pharmacies.  The number of these 
beneficiaries meeting these strict criteria significantly decreased the 
following year, with 2,452 of the beneficiaries at serious risk in 2017 
receiving high amounts of opioids and having four or more prescribers and 
four or more pharmacies again in 2018.  
For beneficiaries at serious risk in 2017, these decreases show apparent 
progress from the efforts of HHSincluding CMS and OIGand the efforts 
of others to address the opioid crisis.  While we recognize the apparent 
progress for this group of beneficiaries, it is important to note that most of 
them continued to receive high amounts of opioids in 2018 and continued 
to face considerable risk.   
 
Eleven percent of  Eleven percent of the beneficiaries at serious risk in 2017 (8,153 of 
71,260 beneficiaries) had an overdose or an adverse effect from opioids in 
beneficiaries at 
2017 or the following year. 
serious risk in 2017 
A total of 3,320 beneficiaries at serious risk in 2017 had an overdose in 2017 
had an overdose or 
or 2018.  This is about 5 percent of the beneficiaries at serious risk in 2017.  
an adverse effect 
Overdoses occur when high doses of opioids, alone or in combination with 
from opioids    other substances, cause breathing to slow to dangerous levels or stop 
altogether.  
Beneficiaries who appeared to be doctor shopping in 2017 were more likely 
to have an overdose than those who received extreme amounts of opioids.  
Nine percent of beneficiaries who 
appeared to be doctor shopping in 
   Beneficiaries who 
2017 had an overdose in 2017 or 
appeared to be doctor 
2018, while 4 percent of beneficiaries 
shopping were even more 
who received extreme amounts of 
likely to have an overdose.  
opioids had an overdose during the 
same time.6  
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Notably, there may have been more beneficiaries who had an overdose but 
did not receive care billed to Medicare.   
An additional 4,833 beneficiaries at serious risk in 2017 had an adverse 
effect caused by an opioid during the year or 2018.  Most of these 
beneficiaries3,100 of 4,833received emergency care for these adverse 
effects.   
 
About one-quarter  A total of 16,03623 percentof the beneficiaries at serious risk in 2017 
received naloxone prescriptions through Medicare Part D in 2017 or 2018.  
of beneficiaries at 
Naloxone is a medication that can reverse the effects of an opioid overdose.  
serious risk in 2017 
When naloxone (such as the 
received a  brand-name drug Narcan) is 
    Naloxone is a safe antidote 
administered in a timely 
prescription for 
to an opioid overdose.  When 
fashion, it can save lives by 
naloxonea drug  given in time, naloxone can save 
blocking the effects of 
lives. 
that reverses opioid 
opioids and restoring normal 
overdoses  breathing.   
through Part D      
Ensuring that at-risk individuals have naloxone on hand in the event of 
an overdose is critical for reducing the number of overdose deaths.  
Accordingly, in December 2018, HHS recommended that providers strongly 
consider prescribing naloxone to patients with an increased risk of opioid 
overdose, such as those who receive higher opioid amounts and those with 
a history of overdose.7   
Beneficiaries may receive naloxone from sources other than Part D.  
Notably, most States allow for third-party prescriptions, which means that 
family members or friends of an at-risk patient can get a prescription for 
naloxone in their own names.8  In addition, a number of recent initiatives 
have increased community-based distribution of naloxone.9    
 
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About 48 percent (34,365) of the 
About half of the 
Exhibit 1.  Signs of opioid 
beneficiaries at serious risk in 2017 
beneficiaries at  use disorder can include:* 
had a diagnosis of opioid use 
serious risk in 2017  disorder or a diagnosis related to 
o often taking opioids in larger 
have been  the misuse of opioids in 2017 or 
amounts or over a longer period 
2018.   
diagnosed with 
than was intended; 
opioid use disorder  In total, 44 percent (31,468) of 
o having a persistent desire (or 
beneficiaries at serious risk in 2017 
or other conditions 
making unsuccessful efforts) to 
had a diagnosis of opioid use 
related to the  cut down or control opioid use; 
disorder.  This diagnosis indicates 
misuse of opioids  that an individual has 
o spending a great deal of time 
   a problematic pattern of opioid 
obtaining opioids, using opioids, 
use that leads to clinically 
or recovering from their effects; 
significant impairment or distress.  
Opioid use disorder is sometimes  o craving opioids; and 
referred to as opioid addiction.  
o failing to fulfill major obligations 
Patients with a diagnosis of opioid 
at work, school, or home 
use disorder may require 
because of recurrent opioid use. 
medication-assisted treatment 
(MAT), which combines  *For a complete list of signs, see Appendix B. 
medication with counseling and  Source:  Diagnostic and Statistical Manual of 
Mental Disorders: DSM-5, 2013.   
behavioral therapy.  Diagnosing 
opioid use disorder requires 
a thorough evaluation, which may include, for example, checking the 
patients history of opioid prescriptions or testing the patients urine for 
drugs.10  To receive a diagnosis, a patient must have two or more signs of 
the disorder, such as those listed in Exhibit 1.  For more information about 
the signs of opioid use disorder, see Appendix B.   
Opioid use disorder can range from mild to severe.  A diagnosis of 
moderate-to-severe opioid use disorderalso known as opioid 
dependencewas among the most common diagnoses for beneficiaries at 
serious risk in 2017.   
An additional 4 percent of beneficiaries at serious risk in 2017 
(2,897 beneficiaries) had diagnoses related to the misuse of opioids.  These 
beneficiaries did not have a diagnosis of opioid use disorder, but they had 
other concerning opioid use.  For example, a number of beneficiaries were 
diagnosed with opioid intoxication or opioid withdrawal (in the absence of 
opioid use disorder).  
 
 
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Only 7 percent of  Seven percent of beneficiaries 
Exhibit 2.  Medication-Assisted 
at serious risk in 2017 who were 
beneficiaries with  Treatment 
diagnosed with opioid use 
opioid use disorder 
disorder received a drug for  o MAT is a proven method of 
received MAT drugs  MAT through Part D.11  MAT is a  treating opioid use disorder that 
through Part D,  proven method of treating  combines medication with 
opioid use disorder and can  counseling and behavioral therapy. 
possibly because of 
prevent relapse.12  It combines 
o Part D covers two MAT drugs for 
challenges that 
medicationreferred to as 
opioid use disorder when they are 
beneficiaries have in  MAT drugswith counseling 
appropriately prescribed:  
and behavioral therapies to 
accessing 
buprenorphine and naltrexone. 
treat substance use disorders, 
prescribers  
including opioid use disorder.  
In total, 2,123 of the 31,468 beneficiaries at serious risk in 2017 who had 
opioid use disorder received MAT drugs through Part D in 2017 or 2018.   
Part D covers two medications approved for treating opioid use disorder:  
buprenorphine and naltrexone.  Buprenorphine is the MAT drug that is 
most commonly received by serious-risk beneficiaries with opioid use 
disorder.  Buprenorphine suppresses opioid withdrawal symptoms and 
relieves cravings.  In total, 2,069 of the beneficiaries at serious risk with 
opioid use disorder received 
buprenorphine through Part D           Exhibit 3.  Buprenorphine 
in 2017 or 2018.13  Only certain  Waiver Program 
healthcare practitioners may 
o  Health care providers who have 
prescribe buprenorphine for 
received a buprenorphine waiver 
MAT; see Exhibit 3 for 
from the Substance Abuse and 
information about the waiver 
Mental Health Services 
program that allows providers 
Administration (SAMHSA) are 
to prescribe buprenorphine. 
allowed to prescribe 
Naltrexone was less commonly  buprenorphine in an office-based 
used among beneficiaries at  setting. 
serious risk in 2017 with opioid 
o  The waiver program is intended to 
use disorder.14  This drug is 
increase access to quality 
reported to reduce opioid 
buprenorphine treatment from 
cravings; however, a patient 
trained providers while also 
must go through full 
preventing drug diversion. 
detoxification before beginning 
naltrexone for MAT.  In total,  o  To qualify for a waiver, providers 
84 of the beneficiaries at  must have completed approved 
serious risk with opioid use  addiction training. 
disorder received naltrexone 
o  Waivered providers are limited in 
through Part D in 2017 or 
2018.15    the number of patients they may 
treat. 
 
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The limited number of beneficiaries with opioid use disorder who received 
MAT drugs through Part D may result, in part, from beneficiaries having 
challenges in accessing providers who can prescribe buprenorphine.  
Although Part D is not the only source for MAT drugs, it is an important 
source.   
About one-quarter of beneficiaries at serious risk in 2017 who had opioid 
use disorder8,305 of the 31,468live in counties with limited to no access 
to providers who can prescribe buprenorphine for MAT.16   
Of the 8,305 beneficiaries with limited access, 1,620 live in counties with no 
healthcare providers who can prescribe buprenorphine for MAT.  The 
remaining 6,685 live in counties that have limited capacity to treat patients, 
meaning that the total number of patients that providers in these counties 
are permitted to treat is low. 
It is important to note that some beneficiaries may be receiving MAT drugs 
from other sources, such as opioid treatment programs (sometimes referred 
to as methadone clinics).  Methadone is not covered by Part D when it is 
used for MAT.17  On January 1, 2020, Medicare Part B began covering 
methadone that is provided by opioid treatment programs.    
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CONCLUSION AND RECOMMENDATION 
Gaining a deeper understanding of beneficiaries who are at serious risk of 
opioid misuse or overdose is vital to addressing the Nations opioid 
epidemic.  The need for this information has become even more critical 
given the additional danger that the respiratory illness COVID-19 presents to 
beneficiaries with opioid use disorder.  This data brief takes an in-depth 
look at 71,260 beneficiaries whom OIG identified as being at serious risk in 
2017, determining the following: their opioid amounts; the extent to which 
they had opioid overdoses; the extent to which they received naloxone 
through Medicare Part D; and the extent to which they have opioid use 
disorder and received MAT drugs through Part D. 
Most beneficiaries at serious risk in 2017 received high amounts of opioids 
in the following year.  Raising even more concern, 11 percent of beneficiaries 
at serious risk in 2017 had an overdose or an adverse effect from an opioid.  
About one-quarter of beneficiaries at serious risk in 2017 received a 
prescription for naloxonean opioid-overdose reversal drugthrough 
Part D.  About half of the beneficiaries at serious risk in 2017 have been 
diagnosed with opioid use disorder or other condition related to the misuse 
of opioids.  However, only 7 percent of beneficiaries at serious risk in 2017 
who were diagnosed with opioid use disorder received MAT drugs through 
Part D, possibly because of challenges that beneficiaries have in accessing 
prescribers.  Note that beneficiaries may receive MAT drugs or naloxone 
from sources other than Medicare.   
This data brief indicates that many beneficiaries at serious risk of misuse or 
overdose may need their care to be reassessed.  CDC recommends that for 
patients who are already taking high dosages of opioids, prescribers should 
offer the patients the opportunity to re-evaluate their continued use of 
these dosages, and prescribers should offer to work with these patients to 
taper their opioids to safer dosages.  HHS recently issued a guide for 
clinicians on how to appropriately reduce or discontinue long-term use of 
opioids.  In addition, CMS is implementing a number of new initiatives to 
address opioid overutilization and encourage coordination of care in 
Part D.18   
This data brief also demonstrates that opportunities exist for CMS to expand 
its role in ensuring that beneficiaries receive treatment for opioid use 
disorder.  CMS is taking some significant steps by implementing the 
SUPPORT for Patients and Communities Act.  In addition, CMS has taken a 
number of steps to improve access to MAT drugs and naloxone through 
Part D.19  Yet, other opportunities exist for CMS to ensure that beneficiaries 
receive treatment.  Specifically, we recommend that CMS: 
   
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Educate Part D beneficiaries and providers about access to MAT 
drugs and naloxone  
CMS plays an important role in education and awareness among 
beneficiaries and healthcare providers about treatment and coverage under 
Medicare.  CMS should determine the best strategies to increase awareness 
among beneficiaries and healthcare providers about access to MAT drugs 
under Part D and under the new changes to Medicare Part B, which covers 
opioid use disorder treatment and MAT drugs.20  For example, CMS could 
expand its outreach by enhancing its webpage for beneficiaries to 
comprehensively explain this information, including coverage of MAT drugs 
under Part B and Part D, and how to find outpatient treatment programs 
and providers who can prescribe buprenorphine.  This outreach should also 
include information about access to naloxone.  In addition, CMS could 
partner with Part D sponsors to increase awareness among Part D 
beneficiaries about access to MAT drugs and naloxone. 
Further, we encourage CMS to partner with the Substance Abuse and 
Mental Health Services Administration (SAMHSA) when developing 
strategies to educate beneficiaries and providers.  For example, CMS could 
partner with SAMHSA to provide Part D beneficiaries with information about 
the specific providers in their area who can prescribe MAT drugs.  CMS 
could also partner with SAMHSA to send letters to providers who serve Part 
D beneficiaries in areas with limited or no providers who can prescribe 
buprenorphine for MAT.  These letters could inform providers about the 
need for SAMHSA-waivered providers in their area and include instructions 
about how to become a waivered provider.   
 
 
 
 
   
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AGENCY COMMENTS AND OIG RESPONSE 
CMS concurred with our recommendation to educate Part D beneficiaries 
and providers about access to MAT drugs and naloxone.  CMS stated that it 
currently partners with Part D plan sponsors to promote awareness of 
opioid treatment and coverage options and that it will consider additional 
ways to increase awareness among beneficiaries and health care providers 
about opioid treatment and coverage options under Medicare, including 
providing additional information about coverage of MAT drugs and 
naloxone on its websites and in the Medicare & You handbook.  CMS stated 
that it will also continue to work with its partners within HHS as it develops 
strategies for educating beneficiaries and providers.  
OIG appreciates CMSs efforts to promote awareness of opioid treatment 
and coverage options.  OIG urges CMS to specifically partner with SAMHSA 
when developing additional strategies to educate beneficiaries and 
providers.   
For the full text of CMSs response, see Appendix C.  
 
   
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METHODOLOGY 
We based this data brief on an analysis of prescription drug event (PDE) 
records, Medicare Claims Data, and Part C Encounter data.  Part D sponsors 
submit a PDE record to CMS each time a drug is dispensed to a beneficiary 
enrolled in their plans.  Each record contains information about the drug 
and the beneficiary.  The National Claims History File contains claims data
including diagnosis codesfrom Medicare Parts A and B.  Part C Encounter 
Data contain medical claims dataincluding diagnosis codesfor 
beneficiaries enrolled in Medicare Advantage plans. 
This review focuses on 71,260 beneficiaries whom OIG identified as being at 
serious risk of opioid misuse or overdose in 2017.  These include 
57,611 beneficiaries who received extreme amounts of opioids and 
14,814 beneficiaries who appeared to be doctor shopping.21  We conducted 
the analyses described below for beneficiaries at serious risk.  
Opioid Amounts 
First, we determined the extent to which these beneficiaries at serious risk 
received high amounts of opioids in 2018 using CDCs MME conversion file 
and the PDE records.  CDCs MME conversion file contains information 
about each opioids drug morphine milligram equivalence.  To determine 
each beneficiarys average daily MED, we first calculated the MED for each 
opioid prescription (i.e., PDE record).22  We did this using the following 
equation: 
 
(Strength per unit)(Quantity dispensed)(MME conversion factor)
MED =  
(Days supply)
 
We then summed each beneficiarys MED for each day of the year using the 
dates of service and days supply on each PDE record.  We refer to this as 
the daily MED.   
Next, we calculated each beneficiarys average daily MED over each 90-day 
period in 2018 and for the entire year.  We excluded beneficiaries with a 
diagnosis of cancer or a hospice stay at any point in 2018 from the analysis 
of opioid amounts.23 
We then determined the proportion of the 71,260 beneficiaries who 
received a high amount of opioids in 2018, i.e., they had an average daily 
MED of greater than 120 mg for any 90-day period in 2018 and they 
received opioids for 90 days or more in 2018.  We also determined the 
proportion of 71,260 beneficiaries who had an average daily MED of greater 
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than 240 mg for any 90-day period in 2018 and the proportion who had an 
average daily MED of greater than 240 mg for the entire year of 2018.  We 
also determined the proportion of the 71,260 beneficiaries who received 
high amounts of opioids and had 4 or more prescribers and 4 or more 
pharmacies for opioids in 2018.   
Opioid Overdoses  
Next, using inpatient and outpatient claims data from the National Claims 
History File and Part C Encounter Data, we determined the extent to which 
the 71,260 beneficiaries had an opioid-related overdose in 2017 or 2018.  We 
considered a beneficiary to have had an overdose if he or she had at least 
one claim from Medicare Parts A, B, or C with a diagnosis of an opioid 
poisoning from prescription or illicit opioids.   
For the remaining beneficiaries, we determined the extent to which they had 
an adverse effect caused by opioid use in 2017 or 2018 and the extent to 
which these adverse effects were treated during an emergency care visit
i.e., an emergency room, urgent care, or trauma care visit. 
 
 The ICD-10 diagnosis codes contain specific codes for adverse effect(s) 
from opioids.  We included the codes for adverse effects related to both 
prescription and illicit opioids. 
Naloxone 
We determined the number of beneficiaries at serious risk who received 
naloxonea drug used to reverse opioid overdosesthrough Part D in 
2017 or 2018.  We based this analysis on the PDE records.    
Opioid Use Disorder or Conditions Related to Opioid Misuse  
We then analyzed the data from National Claims History File and Part C 
Encounter Data to determine the extent to which the 71,260 beneficiaries 
had a diagnosis of opioid use disorder or other conditions related to opioid 
misuse in 2017 or 2018.   
Specifically, we calculated the number of beneficiaries with a diagnosis of 
opioid use disorder.  We considered a beneficiary to have opioid use 
disorder if he or she had a diagnosis code categorized as opioid abuse 
(F11.1) or opioid dependence (F11.2).24 
For the beneficiaries who did not have a diagnosis of opioid use disorder, 
we determined the number who had a diagnosis related to the misuse of 
opioids, such as opioid intoxication, or other opioid related disorders.25 
Lastly, we identified the most common diagnoses overall for these 
beneficiaries.26 
Drugs for Medication-Assisted Treatment 
Using the PDE records, we determined the extent to which the 
31,468 beneficiaries who had a diagnosis of opioid use disorder received 
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MAT drugs through Part D for opioid use disorder in 2017 or 2018.  
Specifically, we determined the number and proportion of beneficiaries who 
received buprenorphine indicated for the treatment of opioid use disorder 
or naltrexone indicated for the treatment of opioid use disorder.27  
Next, using data from the OIG data brief Geographic Disparities Affect Access 
to Buprenorphine Services for Opioid Use Disorder (OEI-12-17-00240), we 
determined the proportion of beneficiaries with opioid use disorder who 
lived in counties with no or low capacity to provide buprenorphine for 
MAT.28    
Limitations  
This study is based on an analysis of Medicare claims data, Part C Encounter 
data, and PDE records.  Beneficiaries in this analysis may have received 
additional services or drugs through other payers, such as Medicaid.  For 
example, beneficiaries may have received methadone in an opioid 
treatment program that is not included in this analysis.  
 
Standards  We conducted this study in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General on 
Integrity and Efficiency. 
 
 
   
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APPENDIX A:  COMMON DIAGNOSES 
Exhibit A-1:  Most Beneficiaries at Serious Risk in 2017 Had Diagnoses of Chronic Pain or Back 
Pain; Many Also Had One or More Common Chronic Diseases or Conditions. 
Number of 
ICD-10-CM  Serious-Risk 
Description   Percentage 
Code  Beneficiaries 
With Diagnosis 
I10  Essential (primary) hypertension  52,587  74% 
G89.29  Other chronic pain  51,841  73% 
M54.5  Low back pain  51,031  72% 
G89.4  Chronic pain syndrome  47,160  66% 
F41.9  Anxiety disorder, unspecified  35,404  50% 
E78.5  Hyperlipidemia, unspecified (high cholesterol)  34,953  49% 
K21.9  Gastroesophageal reflux disease without esophagitis (GERD)  33,029  46% 
F32.9  Major depressive disorder, single episode, unspecified  30,864  43% 
M54.2  Cervicalgia (neck pain)  29,712  42% 
Note:  Beneficiaries may have more than one diagnosis. 
S ource:  OIG analysis of 2017 and 2018 Medicare claims data, 2019. 
 
   
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APPENDIX B:  OPIOID USE DISORDER 
Exhibit B-1: Diagnostic Criteria for Opioid Use Disorder* 
 
1.  Opioids are often taken in larger amounts or over a longer period than was intended. 
2.  There is a persistent desire or unsuccessful efforts to cut down or control opioid use. 
3.  A great deal of time is spent in activities necessary to obtain the opioid, use the opioid, or recover 
from its effects. 
4.  Craving, or a strong desire or urge to use opioids. 
5.  Recurrent opioid use resulting in a failure to fulfill major role obligations at work, school, or home. 
6.  Continued opioid use despite having persistent or recurrent social or interpersonal problems caused 
or exacerbated by the effects of opioids. 
7.  Important social, occupational, or recreational activities are given up or reduced because of opioid 
use. 
8.  Recurrent opioid use in situations in which it is physically hazardous. 
9.  Continued opioid use despite knowledge of having a persistent or recurrent physical or 
psychological problem that is likely to have been caused or exacerbated by the substance. 
10. Tolerance, as defined by either of the following: 
o  A need for markedly increased amounts of opioids to achieve intoxication or desired effect. 
o  A markedly diminished effect with continued use of the same amount of opioid. 
11.  Withdrawal, as manifested by either of the following: 
o  The characteristic of opioid withdrawal syndrome. 
o  Opioids (or a closely related substance) are taken to relieve or avoid withdrawal symptoms. 
 
* For a diagnosis of opioid use disorder, at least 2 of the 12 criteria should be observed within a 12-month period.  The presence of 2 or 3 
symptoms is considered mild opioid use disorder.  The presence of 4 or 5 symptoms is considered moderate opioid use disorder.  Six or more 
symptoms is considered severe opioid use disorder.  There are some exceptions for considering tolerance and withdrawal as critical for opioid 
use disorder if the beneficiary is under appropriate medical supervision.  
Source:  Diagnostic and Statistical Manual of Mental Disorders: DSM-5, 2013. 
 
 
   
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APPENDIX C:  AGENCY COMMENTS 
 
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ACKNOWLEDGMENTS 
Miriam Anderson served as the team leader for this study.  Other Office of 
Evaluation and Inspections staff from the New York regional office who 
conducted the study include Margaret Himmelright and Jason Kwong.  
Office of Evaluation and Inspections staff who provided support include 
Adam Freeman, Christine Moritz, and Michael Novello.  We would also like 
to acknowledge the contributions of other Office of Inspector General staff, 
including Robert Gibbons, Lauren McNulty, and Jessica Swanstrom.  
This report was prepared under the direction of Jodi Nudelman, Regional 
Inspector General for Evaluation and Inspections in the New York regional 
office, and Nancy Harrison and Meridith Seife, Deputy Regional Inspectors 
General.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To obtain additional information concerning this report or to obtain copies, 
contact the Office of Public Affairs at Public.Affairs@oig.hhs.gov.   
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ENDNOTES
 
1 National Institutes of Health, National Institute on Drug Abuse, COVID-19:  Potential Implications for Individuals with 
Substance Abuse Disorders, April 6, 2020.  Accessed at https://www.drugabuse.gov/about-nida/noras-
blog/2020/04/covid-19-potential-implications-individuals-substance-use-disorders on April 9, 2020. 
2 OIG, Opioid Use Decreased in Medicare Part D, While Medication-Assisted Treatment Increased, OEI-02-19-00390, 
July 2019.  OIG, Opioid Use in Medicare Part D Remains Concerning, OEI-02-18-00220, June 2018.  OIG, Opioids in 
Medicare Part D: Concerns About Extreme Use and Questionable Prescribing, OEI-02-17-00250, July 2017.   
3 The Centers for Disease Control and Prevention (CDC) Guideline provides recommendations for prescribing opioids 
for chronic pain outside of cancer treatment, palliative care, and end-of-life care.  It recommends that prescribers 
avoid increasing opioids to morphine equivalent dosages of greater than or equal to 90 mg a day or carefully justify 
the decision to increase to this level.  See CDC, CDC Guideline for Prescribing Opioids for Chronic Pain: United 
States, 2016. MMWR 65, no. 1, March 18, 2016, pp. 149.  Accessed at 
https://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdf on May 28, 2019.  
4 Ibid. 
5 The guide provides insights for clinicians on when and how to work with patients to taper opioids.  It also reiterates 
that under most circumstances, HHS does not recommend abrupt opioid dose reduction or discontinuation.  See 
Department of Health and Human Services, HHS Guide for Clinicians on the Appropriate Dosage Reduction or 
Discontinuation of Long-Term Opioid Analgesics, September 2019.  Accessed at 
https://www.hhs.gov/opioids/sites/default/files/2019-10/8-
Page%20version__HHS%20Guidance%20for%20Dosage%20Reduction%20or%20Discontinuation%20of%20Opioids.p
df on October 21, 2019. 
6 In total, 1,284 of the 14,814 beneficiaries who appeared to be doctor shopping in 2017 had an overdose in 2017 or 
2018.  A total of 2,097 of the 57,611 beneficiaries who received extreme amounts of opioids in 2017 had an overdose 
during the same time. 
7 HHS, HHS Recommends Prescribing or Co-Prescribing Naloxone to Patients At High Risk for an Opioid Overdose 
(December 2018).  Accessed at https://www.hhs.gov/about/news/2018/12/19/hhs-recommends-prescribing-or-co-
prescribing-naloxone-to-patients-at-high-risk-for-an-opioid-overdose.html on October 3, 2019.  Also see HHS, 
Naloxone: The Opioid Reversal Drug that Saves Lives.  Accessed at 
https://www.hhs.gov/opioids/sites/default/files/2018-12/naloxone-coprescribing-guidance.pdf on October 3, 2019.   
8 Prescription Drug Abuse Policy System, Good Samaritan Prevention Laws.  Accessed at 
http://www.pdaps.org/datasets/good-samaritan-overdose-laws-1501695153 on September 24, 2019.   
9 For example, see the Substance Abuse and Mental Health Services Administration (SAMHSA), SAMHSA is 
Announcing the Availability of Up to $4.7 Million for Improving Access to Overdose Treatment grants (April 2018).  
Accessed at https://www.samhsa.gov/newsroom/press-announcements/201804090200 on September 24, 2019. 
10 For more information about assessing a patient for opioid use disorder, see the CDC training, Module 5:  Assessing 
and Addressing Opioid Use Disorder.  Accessed at https://www.cdc.gov/drugoverdose/training/oud/ on January 9, 
2020. 
11 Part D pays for outpatient prescription drugsincluding MAT drugs.  This analysis focuses on beneficiaries with 
opioid use disorder because MAT drugs are indicated for the treatment of opioid use disorder, not for other types of 
opioid misuse. 
12 SAMHSA, Medication and Counseling Treatment.  Accessed at https://www.samhsa.gov/medication-assisted-
treatment/treatment on September 19, 2019. 
13 This includes beneficiaries who received buprenorphine indicated for MAT through Part D.   
 
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14 Naltrexone can be used for individuals with opioid use disorder or alcohol dependence.  See SAMHSA, Naltrexone.  
Accessed at https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone on September 19, 2019.    
15 Thirty of these beneficiaries received both buprenorphine and naltrexone.  
16 We identified these counties on the basis of data from a recent OIG study, Geographic Disparities Affect Access to 
Buprenorphine Services for Opioid Use Disorder, OEI-12-17-00240, January 2020. 
17 Methadone is not covered by Part D when used for the treatment of opioid use disorder because it cannot be 
dispensed for this purpose by a retail pharmacy.  However, beneficiaries may have received methadone from sources 
other than Part D, such as Medicaid.  Therefore, the total number of beneficiaries at serious risk receiving MAT drugs 
may be higher.    
18 For example, since 2019, Part D sponsors have been expected to implement care-coordination alerts at the point of 
sale when a beneficiarys total daily MED reaches or exceeds 90 mg.  Beginning in 2021, Part D sponsors will be 
required to provide a subset of beneficiaries with certain information about the treatment of pain, such as the risks of 
prolonged opioid use and coverage of nonopioid medications.  Beginning in 2022, Part D sponsors will be required 
to have drug management programs for certain at-risk beneficiaries, including those with a history of opioid 
overdose.  See CMS, Announcement of Calendar Year (CY) 2019 Medicare Advantage Capitation Rates and Medicare 
Advantage and Part D Payment Policies and Final Call Letter, April 2018.  Accessed at 
https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf on 
January 8, 2020.  Also see SUPPORT for Patients and Communities Act, P.L. No. 115-271.  Also See CMS, Proposed 
Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2021 
(CMS-4190-P), February 2020.  Accessed at https://www.regulations.gov/contentStreamer?documentId=CMS-2020-
0010-0001&contentType=pdf on February 12, 2020. 
19 For instance, CMS began scrutinizing formulary and benefit designs related to MAT drugs to ensure that plans were 
not discouraging beneficiaries with opioid use disorder from enrolling.  CMS also encourages plan sponsors to 
include at least one naloxone product on their generic or low cost-sharing tier of their formularies.  For more 
information see, CMS, Announcement of Calendar Year (CY) 2020 Medicare Advantage Capitation Rates and Medicare 
Advantage and Part D Payment Policies and Final Call Letter, April 2019.  Accessed at 
https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf on 
January 8, 2020.  
20 Notably, beginning in 2020, Medicare Part B covers methadone provided by opioid treatment programs.  See 
SUPPORT for Patients and Communities Act, P.L. No. 115-271,  2005.  Also see 84 Fed. Reg. 62568 (Nov. 15, 2019). 
21 Beneficiaries who received extreme amounts of opioids each had an average daily MED of greater than 240 mg for 
the entire year and received opioids for 360 days or more in 2017.  Beneficiaries who appeared to be doctor 
shopping each had an average daily MED greater than 120 mg for any 90-day period, received opioids for 90 or 
more days in the year, and received opioids from four or more prescribers and four or more pharmacies in 2017.  
A total of 1,165 beneficiaries were identified as being in both groups.  For more information see OIG, Opioid Use in 
Medicare Part D Remains Concerning, OEI-02-18-00220, June 2018. 
22 To ensure that we included all the opioids each beneficiary used in 2018, we included opioids dispensed in 2017 
with days of use in 2018.  This analysis also excluded PDE records for injection, intravenous, and intrathecal opioids 
because CDC does not publish MME conversion factors for these opioids.  Opioids indicated for MAT were also 
excluded from MED calculations.   
23 We identified beneficiaries with a cancer diagnosis or hospice stay by using CMSs National Claims History File and 
Part C Encounter data.  In total, 5,397 beneficiaries at serious risk of opioid misuse or overdose had a cancer 
diagnosis or hospice stay in 2018. 
24 See ICD-10 CM 2018: The Complete Official Codebook (American Medical Association). 
25 Diagnosis codes that indicate misuse are labeled opioid use (F11.9).  Ibid. 
 
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26 When identifying the most common diagnoses, we did not include diagnosis ICD-10 Z codes because they describe 
factors that influence a patients health statussuch as long-term use of the medicationor describe that a patient 
has received a health services, such as an immunization.  
27 Buprenorphine that is indicated for MAT can be formulated with or without naloxone.  We included both 
formulations in this analysis.   
28 For more information about these counties, see OIG, Geographic Disparities Affect Access to Buprenorphine Services 
for Opioid Use Disorder, OEI-12-17-00240, January 2020.  
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