U.S. Department  of  Health and  Human Services 
Office of  Inspector  General
Data Snapshot
June  2021,  OEI-BL-20-00260 
SAMHSA Is Missing  Opportunities To Better  Monitor Access to 
Medication-Assisted  Treatment  Through  the  Buprenorphine  Waiver 
Program  
What OIG Did 
Combating  the opioid  crisis by expanding treatment  services 
Key Takeaway 
is a key priority for the Substance Abuse and Mental  Health 
Services Administration (SAMHSA).1 The Buprenorphine 
The data  reported  to  SAMHSA  indicated  
Waiver Programone of SAMHSAs primary initiatives to  
that providers who  were waivered at  the  
address this priorityauthorizes 90,000 providers to  provide 
highest  patient  level  treated  an average of  
medication-assisted treatment  (MAT)  to patients with opioid  
116 MAT patients eachfar below the 
use disorder.2  However, SAMHSA  does not  know  how  many 
limit of  275 patients.  However, less than a 
total  patients actually receive MAT  through the program 
quarter of  the providers who  were 
because it  does not  collect  this information from all  enrolled  
required to  submit  data  on their patient  
providers. 
caseloads actually did so.  Although 
SAMHSA  collects these data to monitor 
Instead, SAMHSA  requires a  subset of  waivered  providers 
provider compliance, the agency has 
those authorized  to treat the maximum number of patients 
exercised its discretion and  not  taken 
allowed  by law  (i.e., 275)to  annually report  the number of 
enforcement  actions to improve reporting.  
patients to  whom they provided  MAT.3 The primary purpose 
OIG believes that  these data  have benefits 
of this annual  reporting requirement  is to  allow SAMHSA to  
beyond compliance and  enforcement.  
monitor providers  compliance with additional requirements 
in place for providers authorized  at this 275-patient limit.  
We recommend that  SAMHSA develop 
However, because these data  constitute the only such 
methods to  better measure access to MAT  
information that SAMHSA  collects from waivered providers, 
via waivered  providers.  As policymakers 
OIG used the data  to  examine the waiver programs success 
consider changes to  the waiver program, it  
in a broader  goalexpanding  access to  treatment. Although 
will  be critical to have valid  data on the 
they represent  only a  small  percentage of waivered providers, 
number of  patients accessing  MAT.  With 
the 6,000  providers approved  at the maximum patient  level  
improved data, SAMHSA  could better do 
are important  for access to  MAT, because they are permitted 
the following:  understand  providers MAT 
to treat a  much greater patient load and often specialize in 
prescribing practices; monitor trends in the 
addiction treatment. 
number of  MAT patients being served; 
identify geographic areas where patients 
In this data  snapshot, we examined how  many providers 
with opioid  use disorder remain 
submitted  the required  annual  report  during  2019.  For the 
underserved; and target  where to  deploy 
latest  month with complete data (June 2019), we examined 
its training and technical  assistance 
the number of  MAT patients whom providers reported 
resources.  SAMHSA concurred with this 
treating and whether providers located  in counties with a  
recommendation. 
high need  for MAT  services treated  more patients on average 
than providers located  outside of  these areas.4 
SAMHSA  Is Missing Opportunities  To Better  Monitor  Access  to MAT  Through the Buprenorphine  Waiver Program  1  Results 
In 2019, 77 percent of  providers did not submit required  data to  SAMHSA regarding the number  
of  MAT patients they  served 
  Of the 4,546  providers subject  to  reporting  requirements during  2019, 
77 percent  (3,512  providers)  did not  submit data  to  SAMHSA.5 
  SAMHSA staff  told us  that SAMHSA uses  the  data it does receive to  
inform its MAT policies and  to assess how  localities are performing  in 
the waiver program. 
  Although SAMHSA  sends reminders to  providers when their annual  
reports are due, it  has opted to exercise its enforcement  discretion and  
not take any actions when providers do not comply with reporting  
requirements. 
  SAMHSA  says that  it is electing not  to  enforce the reporting 
requirements because the opioid  crisis is a public health emergency,  
and it does not  want  to  disrupt  patients access to MAT  services by 
rescinding the patient-limit authorization for providers who  fail to   Source: OIG analysis of  data  from the Buprenorphine  
meet administrative requirements.  Waiver  Notification System  (BWNS), 2020. 
Providers who  reported data  to  SAMHSA treated  an  average of  116 MAT  patientsfar  below the 
275-patient limit 
  Nationwide, 66,217  patients received  buprenorphine for MAT from 
the 568  providers who reported  data to SAMHSA  for June  2019 
(the latest  month for which complete data were available).6 
  Although authorized  to  treat  up to  275 MAT patients each, these 
providers each treated  116 patients,  on average, during June 2019. 
  Twenty-nine percent of providers treated fewer than 70 patients. 
In contrast, only 13 percent  (77 providers)  treated at or near the 
275-patient limit  (i.e., 208 or more patients). 
  These results are consistent  with prior studies indicating  that  
providers waivered to treat at the highest  level  were,  on average, 
treating roughly 100 MAT  patients each and that few were treating  
at  or near the 275-patient limit.7, 8 
  An individual  provider who  treats far less than 275  patients
possibly to focus on providing quality care to fewer patients 
Source: OIG  analysis of BWNS  data,  2020. 
does not necessarily indicate a  problem.  
Note: Total  sums to less  than  100 percent because  of  rounding. 
  However, the large proportion of  providers doing  soespecially in 
the midst  of  an opioid  crisisraises overall concerns about 
patients  access to  MAT. 
According  to the limited data  available, providers located  in high-need  counties treated  more 
MAT  patients than  providers located elsewhere 
  In a prior study, we identified 1,119  counties (36 percent  of  U.S. counties)  that  had indicators of  high 
need for MAT  services, according  to  2016  public health data.9 
  Among  the 568 providers who reported  June 2019  data to SAMHSA,  46 percent  were in high-need 
counties.   
  Providers in high-need counties reported  treating  more MAT patients on average than providers in other 
counties127 patients versus 107  patients,  respectively.  
  In high-need counties, 44 percent  of  providers treated  in the upper half  of  the 275-patient limit  (i.e., 139 to  
275 patients), compared  to 32 percent of providers in other counties. 
SAMHSA  Is Missing Opportunities  To Better  Monitor  Access  to MAT  Through the Buprenorphine  Waiver Program  2  Why this Matters 
Access to  MAT  is essential  in addressing the high rates of  opioid  addiction and  overdose mortality.10,  11 
However, many individuals seeking  treatment  face challenges in finding providers who prescribe  MAT  
medications; in obtaining adequate insurance coverage for treatment services; and  in accessing  quality 
legitimate care.12  Periodic independent  studies have indicated  that  access to  MAT  via the Buprenorphine 
Waiver Program is limited  by providers who  treat  substantially fewer patients than their waivers permit and  
also by geographic disparities in where these providers are located.1316  Providers reported  a range of  barriers 
that may limit  their participation, including  regulatory constraints (e.g., monitoring  whether the patient limit  
has been exceeded); constraints from insurance payors (e.g., inadequate reimbursement rates, prior 
authorization requirements); lack of time  for new  patients; lack  of  training or experience working  with patients 
with addiction; lack  of  patient access to mental health and  psychosocial  support services; and  stigmas related  
to addiction  and MAT.1723 
Over the  20-year history of  the waiver program, SAMHSA  and congressional policymakers have  addressed  the  
persistent  problem of  inadequate patient access to MAT  by continually modifying  the waiver program to  
encourage more provider participation.  For example, Congress has twice raised  the patient-limit  levels for 
providers and  also  expanded the  types of  providers (e.g., nurse practitioners, physician assistants) who  qualify 
for waivers.24-27  During  the COVID-19 public health emergency, SAMHSA  and the Drug  Enforcement  Agency 
(DEA)  eased restrictions so that  patients could  receive MAT  via telemedicine.28, 29  Further, in April 2021,  
SAMHSA  exempted  providers who  treat  up to  30 MAT patients from training  requirements and from a  
mandate to  offer MAT patients counseling and psychosocial  services.30  Additionally, members of  Congress 
have reintroduced  bipartisan proposals that  would  eliminate the waiver program altogether, so that  any 
provider with prescribing  privileges could provide MAT.31 
Despite these ongoing  efforts to  increase patient access, SAMHSA  remains hard-pressed to  monitor how  many 
patients are actually served  by the  waiver program and  to identify unmet needsmuch less address the more 
difficult  issue  of  ensuring  quality care.  SAMHSA  does not collect data on the number of  patients served  by 
most waivered  providers (i.e.,  those authorized  at the 30-and 100-patient limit  levels).  Therefore,  its only 
consistent source of  patient  access information is from the annual  reports submitted by providers authorized  
to  treat  up to 275 patients.   However, because  three-quarters of  these providers did  not  submit the required  
data, SAMHSAs ability to use this information for any purpose is extremely limited. 
As the Department  of  Health and  Human Services and  policymakers consider additional  changes to  the waiver 
program, it will  be criticalat  a minimumfor any new  proposals to  address the need for valid data  on the 
number of  patients accessing  MAT services. In the absence of  such data, SAMHSA  will not  have reliable 
information to evaluate how  changes in buprenorphine policy affect  patient access to MAT.  For example,  
telemedicine holds promise for addressing longstanding  geographic disparities in the availability of  waivered  
providers, but  without  more valid  data, SAMHSA  will  not know  whether easing  telemedicine restrictions 
succeeded in expanding  patients  access. 
What  OIG Recommends 
To ensure access to  MAT, SAMHSA  should:  
Develop  comprehensive methods  and  measures  to assess  access to MAT  via waivered  providers 
SAMHSA currently collects data  from waivered  providers for compliance and  enforcement  purposes.  We 
recommend  that  SAMHSA  expand the way it  uses data  to  also measure performance on an overarching  agency 
goalcombating  the opioid  crisis through the expansion of  treatment  services. In the regulations 
implementing  the reporting  requirement, SAMHSA  noted its need  to balance program oversight  with reducing  
the burden on providers participating  in the  program.32  Minimizing  burden is important  because the 
buprenorphine waiver program is completely voluntary and  does not  directly reimburse providers for MAT  
services, meaning that  SAMHSA  has few  incentives at its disposal to encourage  providers compliance with 
SAMHSA  Is Missing Opportunities  To Better  Monitor  Access  to MAT  Through the Buprenorphine  Waiver Program  3  program requirements.  OIG recognizes that although SAMHSA  would  be permitted to revoke the  275-patient  
limit authorization for the  three-quarters of providers who fail to report, doing so  would  undermine SAMHSAs 
goal  of  increasing patient  access to  MAT during the overdose epidemic.  
Given the competing  demands of  ensuring  compliance with reporting  requirements and maintaining  patient  
access, SAMHSA should  consider alternative methods for assessing  whether the agency is achieving  its goal of  
increasing access to  MAT.   Rather than relying on individual providers to  report  data,  SAMHSA  could  develop 
its own capacity to collect and  analyze existing  administrative data  from other sources to monitor access to  
MAT.  This approach aligns with the Foundations for Evidence-Based  Policymaking  Act of  2018, which requires 
Federal agencies to securely use data that the government already collects to better inform policy decisions 
and also encourages data-sharing  between agencies.33 In January 2021, SAMHSA announced it  was working  
with interagency partners to  examine ways to increase access to buprenorphine, reduce overdose rates, and 
save lives.34 In undertaking  this effort, SAMHSA  should also review available sources of  data  on patient  access,  
identify ways to improve the quality of  its data, and  increase its use  of  relevant  data  in ongoing  agency 
decision-making.  For example, SAMHSA  could partner with other stakeholders addressing  the opioid  crisis, 
such as the Centers for Disease Control  and  Prevention (CDC),  the Centers for Medicare and  Medicaid  Services, 
and  Prescription Drug Monitoring  Programs (PDMPs),  potentially linking  its own data on waivered providers to  
data  collected  by these others.  Alternatively, instead of  accessing data  from the 54 State-specific PDMPs, 
SAMHSA  could purchase commercial  prescribing  data to obtain nationwide data on trends in buprenorphine 
prescribing. With improved data, SAMHSA  could better understand providers  buprenorphine prescribing 
practices; monitor trends in the number of  MAT patients being served; identify geographic areas where 
patients with opioid  use disorder remain underserved; and  target where to deploy its training and  technical  
assistance resources.  
Agency Comments and  OIG  Response 
SAMHSA  concurred  with this recommendation and  stated  that data on patient access to MAT  would  be useful.  
However, SAMHSA  stated that  it  has neither statutory obligation nor authority under the  applicable  waiver 
statutory scheme to  collect  waivered  provider information for the purpose of  assessing  access to  MAT.  While 
OIG agrees that  SAMHSA  has no  statutory obligation to  collect  such information for this purpose, OIG 
disagrees that  SAMHSA  is precluded  from doing  so.  SAMHSAs organic statute35 gives it  broad  authority to  
analyze data  to assess and  improve access to  waivered  MAT providers.   Moreover, SAMHSA  and congressional  
policymakers are considering  further changes to  the program to  increase access (e.g., easing telehealth 
requirements, reducing training  requirements for providers, eliminating the waiver altogether)making the 
need  for valid comprehensive data  on patient access to  MAT even more pressing. 
SAMHSA  stated  that to fully understand access to buprenorphine,  it  is important  to capture data on the 
prescribing practices of  providers in regular primary care, community health, and emergency room settings, in 
addition to the addiction specialists with 275-patient  limit waivers.  OIG  agrees and  in our recommendation, we 
suggested  several  possible  ways to gather such information.   We recognize that SAMHSA  may ultimately 
determine that some suggestions are not feasible (e.g., gathering  data from multiple  State-specific PDMPs) or 
are expensive (e.g.,  purchasing  commercial data).  Therefore, we recommended that  SAMHSA should  conduct 
a thorough review of  the available sources of  data  on patient access and determine which sources provide 
relevant, feasibly obtainable, and high-quality information on patient access to MAT.  Such a  review  could be 
part  of  SAMHSAs new interagency work  group on increasing access to buprenorphine, so  that  the  work  group 
has reliable data both to inform its deliberations on additional  program changes and  to monitor the 
subsequent  effects on patient access.  
Our recommendation also  provides a  way for SAMHSA to  decrease regulatory burdens for practitioners, which 
SAMHSA  noted  it has been under pressure to  do.  If SAMHSA  developed its own capacity to  collect  and  use 
existing  administrative data  to  monitor access to  MAT, it  could  reduce the need  for individual  providers to  
report such data. Lastly, although SAMHSA collects data  on MAT  access through its grant  programs, it  is 
unlikely that  these data  would  fully capture the number of  patients treated  by waivered  providers, who  work  
primarily in health care settings and do  not receive SAMHSA  grant funding. 
SAMHSA  Is Missing Opportunities  To Better  Monitor  Access  to MAT  Through the Buprenorphine  Waiver Program  4  Methodology 
Scope 
This analysis focused on 4,546  providers participating  in SAMHSAs Buprenorphine Waiver Program who  were 
authorized  to treat up to 275 patients concurrently in 2019.   Providers waivered  at lower patient-limit levels  
(i.e., 30 or 100 patients) were excluded  from this review  because  SAMHSA  does not collect comparable 
information from these providers.  The study also  excluded buprenorphine  prescribed  for other purposes (e.g., 
pain management)  and  in other settings (e.g.,  opioid treatment programs). 
Data Sources 
Buprenorphine Waiver Notification System (BWNS).  SAMHSA  collects and stores buprenorphine waiver 
applicant  information in the BWNS.  This system includes data  on each applicants address, the patient-limit  
level  at which the applicant  was authorized, and the year of  waiver approval.  The BWNS also includes the 
information that providers at the 275-patient  limit  report  annually to SAMHSA.   Each provider reports the 
number of  patients to  whom the provider prescribed or dispensed  MAT medications during each of  the 
preceding  12 months (e.g., 71 patients in April, 103  in May, and  99 in June).  SAMHSA  receives these reports on 
a rolling basis throughout  the year, because each providers report  is due within 30 days of  the anniversary of  
when the provider was originally approved  at the 275-patient level.  
When we received  BWNS data  in June 2020, 6,137  total  providers were waivered  at the 275-patient  limit.  Of  
these, 4,546  providers were required  to report  data  to  SAMHSA  at some point  during 2019.   The remaining  
1,591  providers had  been more recently authorized  at  the 275-patient limit  level and  therefore had  not  yet  
reached  their 1-year anniversary and  thereby the deadline to send  the annual report  to SAMHSA.  
Because providers report  the aggregate number of  MAT patients per month (rather than the annual total  
number of  patients they treated), our patient-level analyses compared  prescribing across providers during  a  
single monthJune 2019.   We selected  June 2019  because it  was the most recent month for which complete 
data  should  have already been reported  to  SAMHSA.  Of  the 4,546  providers who reported data  to  SAMHSA at 
some point  in 2019,  568 reported  data  about  their MAT  prescribing  for the month of  June 2019.    
High-Need  Counties Identified  by  OIG. In OIGs  prior report, we identified  a list  of  1,119  counties (constituting  
36 percent of U.S. counties)  that had  high needs for MAT  services.36  We used  three public health data  
measures to identify these counties:  2016  drug  overdose mortality data,37 2016  opioid  prescribing rates from 
retail pharmacies,38 and 20122014  prevalence rates of  nonmedical  use of  pain relievers.39  If  a county had high 
rates (i.e., greater than the 60th percentile of  the distribution)  for at  least  two  of  the three measures of  opioid  
misuse and  abuse, we designated it as having a high need  for MAT services. 
Interview With SAMHSA  Staff.  We interviewed  SAMHSA staff about how the agency currently uses the data  
from the annual  reports submitted by providers at the 275-patient  limit, and  about whether SAMHSA uses any 
additional  data  to  assess access to  MAT through the Buprenorphine Waiver Program.  We also asked  how 
SAMHSA  monitors providers  compliance  with reporting  requirements and whether it  has taken enforcement  
actions against noncompliant  providers. 
Data Analysis 
Providers  Compliance  With Reporting Requirements. We used  BWNS data  to  calculate the number of  providers 
who reported to  SAMHSA within 30 days of their 1-year anniversary of  being approved  at  the 275-patient limit,  
as required.  We excluded providers who  had  been at  the 275-patient  limit  for less than 1 year, because they 
were not yet  required  to report  to SAMHSA. 
Patients Receiving MAT Medications. For the latest  month with complete data  (i.e., June 2019), we calculated the 
nationwide total  and average number of  patients treated  by providers at the 275-patient  limit.  We also 
SAMHSA  Is Missing Opportunities  To Better  Monitor  Access  to MAT  Through the Buprenorphine  Waiver Program  5  calculated the shares of  providers who were treating the following  proportions of the 275-patient limit:   
25 percent  or less (169 patients),  2650 percent  (70138 patients), 5175 percent  (139207 patients),  and  
76 percent  or more (208275  patients).  We determined how  many providers were at or near their patient-
treating capacity (i.e., treating at  least  250 patients, which is over 90 percent of the 275-patient limit).  
Waivered  Providers  Location in High-Need Counties. We compared  each providers county as listed  in the 
BWNS to the  list of  high-need  counties that we identified in our prior study.  For those providers with multiple  
addresses listed  in the BWNS, we selected  the county associated  with the most recent  information that  the 
provider had submitted  to SAMHSA.  We determined  whether providers located  in high-need counties 
reported  treating  more MAT patients than providers in other counties.  
Limitations 
This study relied  on self-reported  data  submitted  by waivered  providers.  We did not  verify the accuracy of  the 
information submitted.  Additionally, to  identify counties with high needs for MAT  services, we used  2014  and  
2016  public health data (the latest  available data  at  the time of our prior report); these  data may no  longer 
reflect  current  county needs in all cases. 
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. 
Acknowledgments 
Heather Barton, a Deputy Regional  Inspector General,  served  as the team leader for this study, and  Tori Lawson 
served  as an analyst.  Other OIG  staff  who  provided  support  include Bahar Adili  and  Christine Moritz.  This 
report  was prepared  under the direction of  David Tawes, Regional  Inspector General  for Evaluation and  
Inspections in the Baltimore regional  office, and  Louise Schoggen, Assistant Regional  Inspector General. 
To  obtain additional information concerning  this report or to  obtain copies, contact  the Office of  
Public Affairs  at  Public.Affairs@oig.hhs.gov.  
SAMHSA  Is Missing Opportunities  To Better  Monitor  Access  to MAT  Through the Buprenorphine  Waiver Program  6  Endnotes 
1.  SAMHSA.  Strategic Plan  FY2019   FY2023.   Available at: https://www.samhsa.gov/about-us/strategic-plan-
fy2019-fy2023. 
2.  The waiver program is intended to increase access to  MAT by authorizing  qualified  providers to prescribe 
buprenorphine to patients in office settings (e.g., primary care practices, community health centers,  
treatment centers)rather than limiting  MAT services to  specialized  opioid treatment  programs.  
3.  42 CFR  8.635.  The purpose of  the reporting  requirements is to  help the Department  of  Health and  
Human Services assess  provider compliance with the additional  responsibilities (i.e., ensuring that  patients 
receive the full  array of services that constitute evidenced-based  MAT) of  providers authorized  to treat up 
to  275 patients.   In addition to  reporting  their monthly caseloads of  MAT patients, these waivered  providers 
also report  the number of  MAT patients who  were referred  to  behavioral  health services and describe the 
features of  their diversion control  plan. 
4.  OIG, Geographic  Disparities  Affect  Access  to  Buprenorphine  Services for Opioid Use Disorder, OEI-12-17-
00240,  January 2020.  In this report, OIG classified a  county as high need for MAT  services if  it  had  high 
rates (e.g., greater than the 60th percentile of  the  distribution)  on at least  two  of  the following  measures:  
2016  drug  overdose mortality data, 2016  opioid prescribing rates from retail  pharmacies, and  20122014  
prevalence rates of  nonmedical  use of  pain relievers. 
5.  Among  the 6,137  total  providers who  were waivered  at the 275-patient  limit, only 4,546  were subject to  
annual  reporting  requirements in 2019.  The remaining  1,591  providers had  received their waivers more 
recently and had not  yet reached  their 1-year anniversary dates,  which were when their annual reports 
would  be due to SAMHSA. 
6.  Among the 1,034  total providers who reported data  to  SAMHSA during  2019, only 568  reported  the 
number of  MAT patients they treated  during June 2019  (the latest month with complete data). 
7.  Jones, Christopher and  McCance-Katz, Elinore F. Characteristics and  Prescribing Practices of  Clinicians 
Recently Waivered  to  Prescribe Buprenorphine for the Treatment of  Opioid  Use Disorder.  Addiction. 2018  
Mar; 114: 471482. 
8.  Duncan,  Alexandra; Anderman,  Jared; Deseran, Travis;  Reynolds,  Ian;  and Stein, Bradley.  Monthly Patient  
Volumes of  Buprenorphine-Waivered  Clinicians in the US.   JAMA  Network Open. 2020 Aug; 3(8):e2014045. 
9.  OIG, Geographic  Disparities  Affect  Access  to Buprenorphine  Services for Opioid Use Disorder, OEI-12-17-
00240,  January 2020.  In this report,  OIG classified a  county as high need for MAT  services if  it  had  high 
rates (e.g., greater than the 60th percentile of  the  distribution)  on at least  two  of  the following  measures:  
2016  drug  overdose mortality data, 2016  opioid prescribing rates from retail  pharmacies, and  20122014  
prevalence rates of  nonmedical  use of  pain relievers. 
10. U.S.  Department  of  Health and Human Services, Facing  Addiction  in America:  The Surgeon  Generals  
Spotlight on Opioids, September 2018.   Available  at  
https://addiction.surgeongeneral.gov/sites/default/files/surgeon-generals-report.pdf. 
11. World  Health Organization, Guidelines  for the  Psychosocially Assisted Pharmacological  Treatment  of Opioid  
Dependence, 2009.  Available at  
http://www.who.int/substance_abuse/activities/treatment_opioid_dependence/en/. 
12. U.S. Government  Accountability Office, Laws, Regulations,  and Other  Factors Can  Affect Medication-Assisted  
Treatment Access, September 2016. 
13. Duncan,  Alexandra; Anderman,  Jared; Deseran, Travis;  Reynolds,  Ian;  and Stein, Bradley.  Monthly Patient  
Volumes of  Buprenorphine-Waivered  Clinicians in the US.  JAMA  Network Open. 2020 Aug; 3(8):e2014045. 
14. Thomas, Cindy P.; Doyle,  Erin;  Kreiner, Peter W.;  Jones, Christopher M.; Dubenitz, Joel; Horan, Alexis; and 
Stein, Bradley D. Prescribing  Patterns of  Buprenorphine Waivered  Physicians.   Drug and Alcohol  
Dependence, 2017 (181). 
15. OIG, Geographic  Disparities  Affect  Access  to Buprenorphine  Services for Opioid Use Disorder, OEI-12-17-
00240, January 2020. 
SAMHSA  Is Missing Opportunities  To Better  Monitor  Access  to MAT  Through the Buprenorphine  Waiver Program  7  16. Andrilla, C. Holly A.; Moore, Tessa  E.; Patterson,  Davis G.; and  Larson,  Eric H.  Geographic Distribution of 
Providers with a DEA  Waiver to Prescribe Buprenorphine for the Treatment  of  Opioid Use Disorder: A 5-
Year Update.   The  Journal of Rural  Health, 2018.
17. GAO,  Laws,  Regulations,  and Other  Factors Can Affect Medication-Assisted Treatment Access, September
2016.  
18. Huhn, Andrew  S. and Dunn, Kelly, E.  Why Arent Physicians Prescribing More Buprenorphine?   Journal of
Substance Abuse Treatment, 2017. 
19. Kermack, Andrea; Flannery, Mara; Tofighi, Babak; McNeely, Jennifer; and Lee, Joshua D. Buprenorphine 
Prescribing Practice Trends and Attitudes Among  New York  Providers.   Journal of  Substance Abuse
Treatment, 2017. 
20. Arfken, Cynthia  L;  Johanson, Chris-Ellen; di  Menze, Salvatore; and  Schuster, Charles R. Expanding 
Treatment Capacity for Opioid  Dependence with Office-Based  Treatment with Buprenorphine: National 
Surveys of  Physicians.   Journal of Substance Abuse Treatment, 2010.
21. DeFlavio, JR; Rolin,  SA; Nordstrom, BR;  and  Kazal, LA.  Analysis of  Barriers to Adoption of  Buprenorphine
Maintenance Therapy by Family Physicians.   Rural and Remote Health, 2015.
22. Hutchinson,  Eliza; Catlin, Mary; Andrilla, C. Holly A.; Baldwin, Laura-Mae; and  Rosenblatt, Roger A. Barriers
to  Primary Care Physicians Prescribing  Buprenorphine.   Annals of Family  Medicine, March/April  2014.  
23. Suzuki, Joji; Connery, Hilary S.; Ellison,  T. V.;  and  Renner, J. A. Preliminary Survey of  Office-Based Opioid
Treatment Practices and  Attitudes Among  Psychiatrists Never Receiving  Buprenorphine Training to Those
Who Received Training  During  Residency.   The American Journal on  Addictions, 2014.
24. Section 1102  of  the Office  of  National  Drug  Control  Policy Reauthorization Act of  2006,  P.L. No. 109-469
(Dec. 29, 2006)
25. 81 Fed. Reg. 44712  (July 8, 2016) 
26. Section 303(a)  of  the Comprehensive Addiction and Recovery Act  (CARA), amending section 303(g)(2) of 
the Controlled  Substances Act 
27. Section 303(g)(2)(G)(iii)(II)  of  the Controlled  Substances Act, as amended  by section 3201(c)  of  the
SUPPORT for Patients and Communities Act.
28. SAMHSA,  Frequently  Asked  Questions: Provision  of Methadone and Buprenorphine for the  Treatment  of
Opioid  Use  Disorder in the COVID-19 Emergency. Available at:
https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
29. DEA,  March 31,  2020  Letter to  DEA  Qualifying Practitioners.  Available at:
https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Final)%20+Esign.pdf.
30. 86 Fed. Reg.  22439  (April  28, 2021).
31. Diamond,  Dan. Lawmakers urge Biden to back opioid-treatment  measure.  Washington Post, February 9,
2021.   Available at: https://www.washingtonpost.com/health/2021/02/09/lawmakers-urge-biden-back-
opioid-treatment-measure/.   
32. 81 Fed. Reg.  66191, 66192 (September 2,  2016);  81 Fed. Reg. 44711, 44738 (July 8, 2016).
33. Foundations for Evidence-Based  Policymaking  Act of 2018,  P.L. No. 115-435 (enacted  Jan. 14,  2019).
34. SAMHSA, Statement Regarding  the X-Waiver (January 25, 2021). Available at:
https://www.samhsa.gov/sites/default/files/statement-regarding-xwaiver.pdf.
35. 42 U.S.C.  290aa(d).
36. OIG, Geographic  Disparities  Affect  Access  to  Buprenorphine  Services for Opioid Use Disorder, OEI-12-17-
00240, January 2020.
SAMHSA  Is Missing Opportunities  To Better  Monitor  Access  to MAT  Through the Buprenorphine  Waiver Program  8  37. We used  all drug  overdose mortality in this report  rather than opioid-specific overdose mortality.  Drug-
specific deaths (e.g.,  the type of opioid  that caused  the overdose)  are  not routinely reported  across all  U.S. 
jurisdictions, therefore, opioid-specific overdose mortality rates potentially underestimate the number of 
actual  opioid  overdose deaths.  Instead, CDC staff  recommended  using  the drug overdose mortality rates
as an indicator of need  for opioid use disorder treatment services.  We  obtained 2016  county-level data 
from CDC. 
38. CDC,  U.S. Prescribing Maps. Available at  https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html.  IQVIA 
(formerly QuintilesIMS)  Transactional Data  Warehouse (TDW) 20062016  is the source for all prescribing 
data.
39. SAMHSA,  Substate  Estimates  of Substance Use  and Mental Illness  from the  20122014  NSDUH: Results and
Detailed Tables.  Available at  https://www.samhsa.gov/samhsa-data-outcomes-quality/major-data-
collections/state-reports-NSDUH/2012-2014-substate-reports.    
SAMHSA  Is Missing Opportunities  To Better  Monitor  Access  to MAT  Through the Buprenorphine  Waiver Program  9  AGENCY COMMENTS
5600 Fishers Lane  Rockville, MD 20857 
www.samhsa.gov  1-877-SAMHSA-7 (1-877-726-4727) 
 
April 22, 2021 
TO:  Suzanne Murrin 
Deputy Inspector General for Evaluation and Inspections 
Department of Health and Human Services Office of Inspector General 
FROM:  Tom Coderre   
Acting Assistant Secretary for Mental Health and Substance Use 
SUBJECT:   OIG Draft Data Snapshot: SAMHSA Lacks Adequate Data to Monitor Access to 
Medication Assisted Treatment Through the Buprenorphine Waiver Program, OEI-BL-20-
00260 
The Substance Abuse and Mental Health Services Administration (SAMHSA) has reviewed the 
subject document and concurs with the recommendations.  SAMHSA offers the attached 
comments for consideration.   
Tom Coderre 
Attachments 
Behavioral Health is Essential to Health  Prevention Works  Treatment is Effective  People Recover 
SAMHSA Is Missing Opportunities To Better Monitor Access to MAT Through the Buprenorphine Waiver Program         10 GENERAL COMMENTS FROM THE SUBSTANCE ABUSE AND MENTAL HEALTH 
SERVICES ADMINISTRATION ON THE OFFICE OF INSPECTOR GENERALS 
DRAFT DATA SNAPSHOT REPORT ENTITLED SAMHSA LACKS ADEQUATE 
DATA TO MONITOR ACCESS TO MEDICATION ASSISTED TREATMENT 
THROUGHTHE BUPRENORPHINE WAIVER PROGRAM, OEI-BL-20-00260  
Overarching Comments:  
The Substance Abuse and Mental Health Services Administration (SAMHSA) appreciates the 
opportunity from the Office of Inspector General (OIG) to review and comment on this report. 
SAMHSA would like to note that monitoring of controlled substances is part of the mission of 
the Drug Enforcement Administration (DEA). The DEA is mandated to enforce the controlled 
substances laws and regulations of the United States. The mission of the Center for Substance 
Abuse Treatment (CSAT) within SAMHSA is to promote community-based substance abuse 
treatment and recovery services for individuals and families in every community.  SAMHSA in 
concert with the DEA already work collaboratively to grant practitioners the DATA 2000 
waiver, but further data about prescribing practices is not readily available at either agency.  
Further, SAMHSA does not have the permission or authority to access the secure DEA 
databases.  
The purpose of the Data Waiver program is to certify that the provider has proper licensing, 
training, and DEA registration.  SAMHSA is not obligated to collect waivered practitioner data 
for those with 30 and 100 patient limits. SAMHSA does not have the authority to require 
practitioners at these levels to provide this information. Providers with 275-level waivers are 
prescribing for the smallest proportion of clients, serving less than 800,000 clients (from OIG 
report), whereas providers with 30 or 100-level waivers have the capacity to serve over 4 million 
clients.  To fully understand access to buprenorphine, it would be important to capture data on 
the prescribing practices of providers in regular primary care, community health, and emergency 
room settings, in addition to the addiction specialists with 275-waivers. This aggregated data 
would provide a complete picture of MAT prescribing in the United States.  
The OIG report states that SAMHSA could also partner with others addressing the opioid crisis, 
such as the Centers for Disease Control and Prevention (CDC) and Prescription Drug Monitoring 
Programs (PDMPs), potentially linking its own data on waivered providers to data collected by 
these others. However, this may be problematic as provisions within the application for the 
SAMHSAs Buprenorphine Waiver Program waiver specify conditions where data can be 
disclosed. This activity would most likely not be a permissible disclosure. PDMP databases are 
state specific and patient centered, and with varied electronic platforms, making interfacing on a 
large scale not feasible. Also accessing PDMP records of individual patients or providers would 
be outside SAMHSAs regulatory authority and scope. The information SAMHSA collects as a 
result of the waiver process is protected by the Privacy Act, thus there are restrictions on how 
SAMHSA can disclose this information. For instance: SAMHSA can only check other data 
sources for the purposes of identifying prescribing over the patient limit as per 42 CFR 8.635 (d). 
Page 2 of 4 
SAMHSA Is Missing Opportunities To Better Monitor Access to MAT Through the Buprenorphine Waiver Program         11 GENERAL COMMENTS FROM THE SUBSTANCE ABUSE AND MENTAL HEALTH 
SERVICES ADMINISTRATION ON THE OFFICE OF INSPECTOR GENERALS 
DRAFT DATA SNAPSHOT REPORT ENTITLED SAMHSA LACKS ADEQUATE 
DATA TO MONITOR ACCESS TO MEDICATION ASSISTED TREATMENT 
THROUGHTHE BUPRENORPHINE WAIVER PROGRAM, OEI-BL-20-00260  
The OIG report states that SAMHSA requires providers authorized at the 275-patient limit to 
submit data explicitly for program integrity purposesdata that could also prove useful in 
gaining insights into the number of patients receiving MAT.  However, because three-quarters of 
the providers did not provide the required data, SAMHSAs ability to use this information for 
any purpose is extremely limited. SAMHSA would contend that while the percentage of 
responders is low, the data is useful and that the response rate is similar to other physician 
surveys. 
Recommendation 1 
SAMHSA should develop comprehensive methods and measures to assess access to MAT 
via office-based providers. 
SAMHSA concurs that comprehensive methods and measures to assess access to Medication 
Assisted Treatment (MAT) via office-based providers are needed. However, SAMHSA lacks 
authority and funding to implement some of the examples set forth in the recommendation. The 
Buprenorphine Waiver Program is not designed to do this. Although the data would be useful, 
SAMHSA has no statutory requirement to collect data on the number of individuals served.  
SAMHSAs statutory obligations are limited to determining whether a practitioner is qualified 
for a waiver based on the information provided in an NOI, and to deliver that determination to 
the Attorney General.  SAMHSA has no statutory obligation nor authority under the applicable 
waiver statutory scheme to collect waivered provider information for the purpose of assessing 
access to MAT. SAMHSA will assess which recommendations and measures the agency 
currently has the authority and capacity to execute and monitor. Additionally, please note, the 
agency as a whole has been under pressure to further decrease regulatory burdens for 
practitioners as these are perceived as significant barriers to expanding access to MAT, and 
additional reporting requirements by practitioners would be contrary to the goal of expanding 
treatment access.  
SAMHSA is committed to improving treatment access and retention to address the opioid crisis.  
The agency has been working with federal and state partners and grantees while also mounting 
efforts to encourage providers to engage in office-based opioid treatment. SAMHSA is also 
committed to reducing barriers and increasing access to all FDA-approved medications for 
MAT.  These efforts are accomplished through outreach to recently waivered providers, training 
and technical assistance programs, and direct support, such as:  
 The Opioid Response Network (ORN), a large technical assistance (TA) and training
effort
 Provider Clinical Support System  Medication Assisted Treatment (PCSS-MAT) and
Provider Clinical Support System  Universities (PCSS-U), https://pcssnow.org/
 Addiction Technology Transfer Centers (ATTC)
Page 3 of 4 
SAMHSA Is Missing Opportunities To Better Monitor Access to MAT Through the Buprenorphine Waiver Program         12 GENERAL COMMENTS FROM THE SUBSTANCE ABUSE AND MENTAL HEALTH 
SERVICES ADMINISTRATION ON THE OFFICE OF INSPECTOR GENERALS 
DRAFT DATA SNAPSHOT REPORT ENTITLED SAMHSA LACKS ADEQUATE 
DATA TO MONITOR ACCESS TO MEDICATION ASSISTED TREATMENT 
THROUGHTHE BUPRENORPHINE WAIVER PROGRAM, OEI-BL-20-00260  
 Rural Opioid Technical Assistance (ROTA) Program, focusing on issues affecting rural
communities.
 Grants to states in order to address access to MAT
 State Opioid Response (SOR) Grant Program
 Tribal Opioid Response (TOR) Grant Program
 Medication Assisted Treatment  Prescription Drug and Opioid Addiction (MAT-PDOA)
Grant Program
 Substance Abuse Prevention and Treatment Block Grant (SABG)
Through these programs, SAMHSA identifies geographic areas where patients with OUD remain 
underserved and deploys training and technical assistance resources accordingly.  SAMHSA is 
also able to document expansion of MAT treatment services.   
In addition to state partners and grantees, SAMHSA will consider the recommendation that it 
might collect and analyze existing administrative data to monitor access to office-based 
treatment services through other sources.  Used in combination with SAMHSAs current Opioid 
Use Disorder (OUD)-related grants and contracts, and knowledge of providers buprenorphine 
prescribing practices, may enhance its understanding of access to MAT provided through office-
based treatment services.   
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SAMHSA Is Missing Opportunities To Better Monitor Access to MAT Through the Buprenorphine Waiver Program         13