DEPARTMENT OF HEALTH & HUMAN SERVICES 
CENTERS for MEDICARE & MEDICAID SERVICES 
7500 Security Boulevard, Mail Stop S2-14-26 
Baltimore, Maryland 21244-1850 
Center for Medicaid and CHIP Services 
CMCS Informational Bulletin 
DATE:   August 5, 2019 
FROM:  Calder Lynch, Acting Deputy Administrator and 
Director Center for Medicaid and CHIP Services  
SUBJECT:  State Guidance for Implementation of Medicaid Drug Utilization Review (DUR) 
provisions included in Section 1004 of the Substance Use-Disorder Prevention that 
Promotes Opioid Recovery and Treatment   for Patients and Communities Act (P.L. 
115-271) 
This guidance provides information to the states concerning implementation of the new Medicaid 
Drug Utilization Review (DUR) provisions that were included in Section 1004 of the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, 
also referred to as the SUPPORT for Patients and Communities Act or the SUPPORT Act,1 that 
are designed to reduce opioid related fraud, misuse and abuse.  This document addresses the 
required implementation of these provisions, including requirements regarding opioid prescription 
claim  reviews  at  the  point  of  sale  (POS)  and  retrospective  reviews;  the  monitoring  and 
management of antipsychotic medication in children; identification of processes to detect fraud 
and abuse; and mandatory DUR report updates, as well as requirements for Medicaid Managed 
Care Organizations (MCOs).2  This guidance also describes the components of the State Plan 
Amendment (SPA) that each state must submit by December 31, 2019, in order to comply with 
these new requirements.  
BACKGROUND 
Section 1927(g) of the Social Security Act (the Act) requires each state to develop a DUR program 
targeted, in part, at reducing clinical abuse and misuse of prescription drugs covered under the 
1 https://www.congress.gov/115/bills/hr6/BILLS-115hr6enr.pdf   
2 Although the text of the provisions added by the SUPPORT for Patients and Communities Act (and therefore, this 
guidance) addresses only MCOs in the managed care context, CMS encourages states to act consistently in imposing 
the new requirements on all managed care plans  with regards to the new responsibilities added by the SUPPORT 
Act.  States may include Prepaid Ambulatory Health Plans (PAHP) and Prepaid Inpatient Health Plans (PIHP) when 
implementing SUPPORT for Patients and Communities Act updates. CMS intends to consider future rulemaking to 
implement the requirements of the SUPPORT for Patients and Communities Act discussed in this Bulletin 
uniformly for all Medicaid managed care plans.  States Medicaid Program.  In implementing these requirements, CMS regulations at 42 CFR 
456.703(e)3,4 require that the state assess drug use information against predetermined standards.  
Pursuant to 42 CFR 456.703(e), these predetermined standards may be developed directly by the 
state or its contractor, obtained by the state through commercial vendors of DUR services, obtained 
by the state from independent organizations, or any combination of these means.  Thus, in 
administering their DUR programs, states have had the flexibility to use standards that may best 
fit their Medicaid programs and patient populations. 
Consistent with section 1927(g)(3)(D) of the Act, CMS requires each State Medicaid Program to 
submit to CMS an annual report on the operation of its Medicaid DUR fee-for-service (FFS) 
program, including information on prescribing patterns, cost savings generated by the states DUR 
program, and the states DUR programs overall operations, including any new or innovative 
practices.  Additionally,  438.3(s)(4) and (5) require any MCO, PIHP or PAHP that covers 
covered outpatient drugs to operate a DUR program that complies with section 1927(g) and 42 
CFR 456, subpart K and to submit detailed information about its DUR program activities to the 
state.  CMS has compiled state Medicaid DUR annual reports since 1995 and has published them 
on Medicaid.gov since 2010.  As part of its 2019 DUR report for Federal Fiscal Year (FFY) 2018 
data, CMS is collecting from states using managed care plans the same DUR data that states report 
on FFS plans.  See 42 C.F.R.  438.3(s).  
The recently-enacted SUPPORT for Patients and Communities Act includes measures to combat 
the opioid crisis in part by reducing opioid abuse and misuse by advancing treatment and recovery 
initiatives, improving prevention, protecting communities, and bolstering efforts to fight deadly 
illicit synthetic drugs.  There are several Medicaid-related DUR provisions contained within 
Section 1004 of the SUPPORT for Patients and Communities Act with respect to FFS and MCO 
pharmacy  programs.    These  provisions  establish  drug  review  and  utilization  standards  to 
supplement existing requirements under Section 1927(g) of the Act, in an effort to reduce opioid-
related fraud, abuse and misuse.  State implementation of these strategies is required by October 
1, 2019, and the Secretary is required to report to Congress starting with information from states 
fiscal year 2020 DUR reports. 
DISCUSSION 
Section 1004 of the SUPPORT for Patients and Communities Act requires states to implement 
minimum opioid standards within their FFS and managed care programs.  Through amendments 
to Section 1902 of the Act, Section 1004 of the SUPPORT for Patients and Communities Act 
requires States to implement safety edits and claims review automated process[es].  CMS 
interprets safety edits to refer to a prospective drug review, of the sort defined in section 
1927(g)(2)(A) of the Act.  These safety edits provide for a prospective DUR review for each 
prescription identifying potential problems at point of sale (POS) to engage both patients and 
prescribers about possible opioid abuse and overdose risk at the time of dispensing.  The POS 
3 With respect to a managed care organization, prepaid inpatient health plan, or prepaid ambulatory health plan that 
provides covered outpatient drugs, see 42 CFR 438.3(s)(4) and (5). 
4 42 CFR 456.703(e). GovInfo, October, 2018. www.govinfo.gov/content/pkg/CFR-2018-title42-vol4/pdf/CFR-
2018-title42-vol4-sec456-703.pdf  
2  prospective safety edits provide real-time information prior to the prescription being dispensed to 
the patients.  When a safety edit is triggered, the pharmacist receives an alert and may be required 
to take further action to resolve the alert before the prescription can be dispensed.5  A claims 
review automated process, which we interpret to refer to a retrospective drug use review of the 
sort defined in section 1927(g)(2)(B) of the Act, provides for additional examination of claims data 
to identify patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care.  
These retrospective claims reviews give healthcare providers access to information relevant to the 
items and services they furnish to beneficiaries, and better enable and encourage prescribers and 
dispensers to minimize opioid risk in their patients, such as avoiding duplicate prescriptions. 
CMS encourages states to develop prospective and retrospective DUR reviews that are consistent 
with medical practice patterns in the state to help meet the health care needs of the Medicaid patient 
population.  In doing so, CMS encourages states to utilize, for example, the 2016 Centers for 
Disease Control and Prevention (CDC) Guideline for primary care practitioners on prescribing 
opioids in outpatient settings for chronic pain.   Translation and support materials related to the 
CDC Guideline are also available. 
The SUPPORT for Patients and Communities Act requires State Medicaid Programs to have in 
place the following:  
I.Claims Review Requirements
1. Safety Edits Including Early, Duplicate, and Quantity Limits:  The SUPPORT for
Patients and Communities Act requires states to have in place prospective safety edits (as
specified by the state) for subsequent fills for opioids and a claims review automated
process (as designed and implemented by the state) that indicates when an individual
enrolled under the State plan (or under a waiver of the State plan) is prescribed a subsequent
fill of opioids in excess of any limitation that may be identified by the state.6  State-
identified limitations should include restrictions on duplicate fills, early fills, and drug
quantity limitations.
The use of multiple opioids is associated with a higher risk of mortality, with mortality risk
increasing  in  direct  relation  to  the  number  of  opioids  prescribed  concurrently.  7,8
Beneficiaries who receive multiple opioids may lack coordinated care and be at higher risk
for opioid overdose.9
5 Prada, Sergio. (2019). Comparing the Medicaid Prospective Drug Utilization Review Program Cost-Savings 
Methods Used by State Agencies in 2015 and 2016. American Health and Drug Benefits. 12. 7-12.  
6 Section 1902(oo)(1)(A)(i)(I) of the Act, as added by section 1004 of the SUPPORT for Patients and Communities 
Act. 
7 Ray WA, Chung CP, Murray KT, Hall K, Stein CM. Prescription of Long-Acting Opioids and Mortality in Patients 
with Chronic Noncancer Pain. JAMA. 2016 Jun 14; 315(22):2415-23. 
8 Baumblatt JA, Wiedeman C, Dunn JR, Schaffner W, et al. High-risk use by patients prescribed opioids for pain 
and its role in overdose deaths. JAMA Intern Med. 2014 May; 174(5):796-801. 
9 Bonnie, Richard J., et al. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits 
and Risks of Prescription Opioid Use. The National Academies Press, 2017. 
3  2.  Maximum  Daily  Morphine  Milligram  Equivalents  (MME)  Safety  Edits:  The 
SUPPORT for Patients and Communities Act requires prospective safety edits (as specified 
by the state) on maximum MMEs that can be prescribed to an individual enrolled under 
the State plan (or under a waiver of the State plan) for treatment of chronic pain and a 
claims review automated process (as designed and implemented by the state) that indicates 
when  an  individual  enrolled  under  the  plan  (or  waiver)  is  prescribed  the  morphine 
equivalent for such treatment in excess of the maximum MME dose limitation identified 
by the state.10 
  
This safety edit must include a MME threshold amount to meet the statutory requirement, 
which may assist in identifying patients at potentially high clinical risk who may benefit 
from closer monitoring and care coordination.11  
 
3.  Concurrent  Utilization  Alerts:    The  SUPPORT  for  Patients  and  Communities  Act 
requires  states  to  have  an  automated  process  for  claims  review  (as  designed  and 
implemented by the state) that monitors when an individual enrolled under the State plan 
(or  under  a  waiver  of  the  State  plan)  is  concurrently  prescribed  opioids  and 
benzodiazepines or opioids and antipsychotics.12  
 
Clinically, through the use of retrospective automated claim reviews, concurrent use of 
opioids  and  benzodiazepines  and/or  opioids  and  antipsychotics,  as  well  as  potential 
complications  resulting  from  other  medications  concurrently  being  prescribed  with 
opioids, can be reduced.  States are reminded that the requirement for a retrospective 
automated  claims  review  added  by  section  1004  of  the  SUPPORT  for  Patients  and 
Communities Act does not preclude the State from also establishing a prospective safety 
edit system to provide additional information to patients and providers at the POS about 
concurrent utilization alerts.13 
 
  Opioid and Benzodiazepines Concurrent Fill Reviews: In 2016, the Food and Drug 
Administration  (FDA)  added  a  boxed  warning  to  prescription  opioid  analgesics, 
opioid-containing cough products, and benzodiazepines with information about the 
serious risks associated with using these medications concurrently.14  This review will 
alert providers when these drugs have been prescribed concurrently to assist in avoiding 
and mitigating these associated risks. 
                                                 
10 Section 1902(oo)(1)(A)(i)(II) of the Act, as added by section 1004 of the SUPPORT for Patients and 
Communities Act. 
11 Staff, News. CDC Clarifies Opioid Guideline Dosage Thresholds. AAFP Home, 12 Jan. 2018, 
www.aafp.org/news/health-of-the-public/20180112cdcopioidclarify.html  
12 Section 1902(oo)(1)(A)(i)(III) of the Act, as added by section 1004 of the SUPPORT for Patients and 
Communities Act. 
13 See Section 1902(oo)(1)(A)(iii) of the Act, as added by section 1004 of the SUPPORT for Patients and 
Communities Act. 
14 Office of the Commissioner. Press Announcements - FDA Requires Strong Warnings for Opioid Analgesics, 
Prescription Opioid Cough Products, and Benzodiazepine Labeling Related to Serious Risks and Death from 
Combined Use. U S Food and Drug Administration Home Page, Office of the Commissioner, 
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518697.htm  
4 
   
  Opioid and Antipsychotic Concurrent Fill Reviews: This alert is supported by the 
FDAs warning of increased risk of respiratory and Central Nervous System (CNS) 
depression with concurrent use of opioid and CNS depressants such as antipsychotics 
or  sedatives,  including  extreme  sleepiness,  slowed  or  difficult  breathing, 
unresponsiveness  or  the  possibility  that  death  can  occur.15    Patients  concurrently 
prescribed opioid and antipsychotic drugs benefit from increased coordination of care. 
Additionally, improving treatment of comorbid mental health disorders is an important 
consideration when trying to reduce the overall negative impacts of opioid use disorders, 
and the treatment of pain.  This review will encourage coordination of care for patients 
taking antipsychotic and opioid medication concurrently.  
 
Permitted Exclusions:  The above described safety edits and claims review requirements added 
by section 1004 of the SUPPORT for Patients And Communities Act to subsection 1902(oo) of 
the Act do not apply with respect to individuals who are receiving hospice or palliative care; 
receiving treatment for cancer;  residents of a long-term care facility, a facility described in section 
1905(d) of the Act, or of another facility for which frequently abused drugs are dispensed for 
residents through a contact with a single pharmacy; or other individuals the state elects to treat as 
exempted from such requirements.16  States are expected to develop specifications that will exclude 
these beneficiaries from all of the opioid review activities outlined above. 
 
When implementing these requirements, CMS encourages states to offer education and training 
and to provide consistent messaging across all healthcare providers.  Education and training of all 
providers  on  new  opioid  provisions  will  help  minimize  workflow  disruption  and  ensure 
beneficiaries have access to their medications in a timely manner.  In order to avoid abrupt opioid 
withdrawal, prior authorization may be necessary for patients who will need clinical intervention 
to taper off high doses of opioids to minimize potential symptoms of withdrawal and manage their  
treatment regimen, while encouraging pain treatment using non-pharmacologic therapies and non-
opioid medications, where appropriate.  CMS recognizes that patients who are on opioid-based 
MAT drugs should continue their therapy without disruption.  In this regard, states may at their 
discretion include these drugs in their DUR programs when clinically appropriate.  
 
II. Program to Monitor Antipsychotic Medications by Children 
 
The state must have in place a program (as designed and implemented by the state), to monitor 
and manage the appropriate use of antipsychotic medications by children enrolled under the State 
plan (or under a waiver of the State plan).17  Additionally the state must submit, annually as part 
of the DUR report under section 1927(g)(3)(D) of the Act, information on activities carried out 
under this program for individuals not more than the age of 18 years old generally, and children 
in foster care specifically.  
                                                 
15 Center for Drug Evaluation and Research. Drug Safety and Availability - FDA Drug Safety Communication: 
FDA Warns about Serious Risks and Death When Combining Opioid Pain or Cough Medicines with 
Benzodiazepines; Requires Its Strongest Warning. U S Food and Drug Administration Home Page, Center for 
Drug Evaluation and Research, https://www.fda.gov/downloads/Drugs/DrugSafety/UCM518672.pdf 
16 Section 1902(oo)(3) of the Act, as added by section 1004 of the SUPPORT for Patients and Communities Act. 
17 Section 1902(oo)(1)(B) of the Act, as added by section 1004 of the SUPPORT for Patients and Communities Act. 
5 
   
III. Fraud and Abuse Identification Requirements  
 
The state must have in place a process (as designed and implemented by the state) that identifies 
potential fraud or abuse of controlled substances by individuals enrolled under the State plan (or 
under a waiver of the State plan), health care providers prescribing drugs to individuals so enrolled, 
and pharmacies dispensing drugs to individuals so enrolled.18  Lock in programs19 and prescription 
drug monitoring programs20 play an important role in detecting and preventing opioid-related 
fraud and abuse.  Data analytics can help to determine the extent to which beneficiaries are 
prescribed high amounts of opioids, identify beneficiaries who may be at serious risk of opioid 
misuse or overdose, and identify prescribers with questionable opioid prescribing patterns with 
respect to these beneficiaries.21  
 
IV. Managed Care Organization Requirements  
 
Each Medicaid MCO within a state must operate a DUR program that complies with the above 
specified requirements.22  Furthermore, states must include these DUR provisions in managed care 
contracts with MCOs by October 1, 2019.  CMS encourages states to consider including similar 
requirements in PIHP and PAHP contracts. 
 
Consistent with section 1902(oo)(1)(A)(ii) of the Act, as added by the SUPPORT for Patients and 
Communities Act, states also must ensure that their contract with an MCO requires that the 
contracted entity has in place, for individuals eligible for medical assistance under the State plan 
(or waiver of the State plan) who are enrolled with the entity, subject to the exemptions for 
individuals described above, safety edits, claims review automated processes, a program to 
monitor antipsychotic medications in children, and fraud and abuse identification requirements, as 
described above. 
 
STATE PLAN AMENDMENT (SPA) REQUIREMENTS 
 
Section. 1004 of the SUPPORT for Patients and Communities Act amends section 1902(a) of the 
Social Security Act to include a new paragraph (85), requiring the State  plan to provide that the 
state is in compliance with the new drug review and utilization requirements set forth in section 
1902(oo) of the Act.  States are required to submit an amendment to their State plan for CMS 
review and approval for implementation of these DUR requirements. 
 
Section 1004 of the SUPPORT for Patients and Communities Act also requires all states to 
implement these requirements by October 1, 2019, and to submit an amendment to their State plan 
no later than December 31, 2019 in order to describe how the state addresses these provisions in 
                                                 
18 Section 1902(oo)(1)(C) of the Act, as added by section 1004 of the SUPPORT for Patients and Communities Act. 
19 Pharmacy Lock-In Programs Slated For Expanded Use. OPEN MINDS, www.openminds.com/market-
intelligence/executive-briefings/pharmacy-lock-programs-slated-expanded-use/  
20 Office of National Drug Control Policy. Prescription Drug Monitoring Program. Prescription Drug Monitoring 
Program, April, 2011. https://www.ncjrs.gov/pdffiles1/ondcp/pdmp.pdf  
21 Beaton, Thomas. Preventing Provider Fraud through Health IT, Data Analytics. HealthPayerIntelligence, 5 Oct. 
2018, https://healthpayerintelligence.com/news/preventing-provider-fraud-through-health-it-data-analytics 
22 H.R. 6. 24 Oct. 2018, www.congress.gov/115/bills/hr6/BILLS-115hr6enr.pdf . Page 17. 
6 
  the State plan.  States are also expected to give appropriate tribal notification, as required, if 
applicable.  
 
CMS understands it may take time for states to implement these new strategies.  The October 1, 
2019 date should give states sufficient time to update systems if not already implemented and to 
document processes, policies and procedures in order to address these new requirements.  
 
Required Provisions to include in State Plans:  
 
In its State plan submission, each state should provide a description of how it currently supports 
or is implementing and providing oversight for the new requirements added by Section 1004 of 
the  SUPPORT  for  Patients  and  Communities  Act  in  the  pharmacy  coverage  pages  (3.1  A 
(Categorically Needy) and, if applicable, 3.1 B (Medically Needy)).  States do not have to list 
specific numbers or quantities in the SPA for the safety edits (e.g. 100 MME quantity limitation, 
do  not  refill  until  75%  used,  etc.),  as  these  could  change  from  time  to  time  based  on 
considerations including updated clinical guidelines.  However, CMS will review each states 
safety edits annually upon submission of the states report required under section 1927(g)(3)(D) 
of the Act to assess the consistency of the states safety edits with current medical best practices, 
for example, as informed by the  current CDC opioid guideline.  Therefore, CMS requests that 
each state address the provisions below in the states SPA submission, in the following order:  
 
1.  Claims Review Limitations:  Describe the opioid related prospective POS safety edits and 
retrospective reviews the state has in place to address: duplicate fill and early fill alerts, 
quantity limits,  dosage  limits,  and MME limitations.  Additionally, describe  concurrent 
utilization reviews for opioids and benzodiazepines or opioids and antipsychotics.  Describe 
all actions for these reviews that will occur. 
 
2.  Program to Monitor Antipsychotic Medications by Children:  Describe the program the 
state uses to monitor and manage utilization of antipsychotic medications in children and foster 
children.  Describe the actions that the state will take based on the monitoring undertaken in 
the program.  
 
3.  Fraud and Abuse Identification:  Describe the state program in place to identify and address 
fraud and abuse.  Describe the actions that the state will take based on the programs findings.  
 
4.  Medicaid Managed Care Organizations Requirements: Specifications regarding MCOs do 
not have to appear on the State plans pharmacy pages, as these pages apply to FFS populations 
only.  However, states should confirm that they have updated their contracts with MCOs to 
comply with the requirements applicable to MCOs as added by section 1004 of the SUPPORT 
for Patients and Communities Act. (Beginning in October 2019, the SUPPORT for Patients 
and Communities Act requires each MCO also be compliant with utilizing safety edits relating 
to subsequent fills of opioids, MME limitations, and concurrent prescribing of opioids and 
benzodiazepines and opioids and antipsychotics.   Additionally, as a reminder, the state is 
required to modify the MCOs contracts regarding these new DUR requirements in order to 
be in compliance by October 1, 2019.)  
 
7 
  Availability of Enhanced Federal Matching Funds 
Under 42 CFR 433.112(a), CMS provides 90 percent enhanced federal financial participation 
(FFP) for Medicaid technology investments for design, development, installation, or  enhancement 
of mechanized claims processing and information retrieval systems, provided they meet specified 
requirements.  Such expenditures to meet the new requirements of section 1004 of the SUPPORT 
for Patients and Communities Act may qualify for this enhanced matching rate.  States should also 
review SMD # 18-006, Leveraging Medicaid Technology to Address the Opioid Crisis, to 
consider if there are complementary efforts around technology that could assist with states efforts. 
Also, states should review section 5042 of the SUPPORT for Patients and Communities Act and 
consider if there are opportunities to acquire technologies which complement these efforts or 
further promote interoperability and data sharing.  These can all be funded through an approved 
Advanced Planning Document (APD) provided the requirements of 42 CFR part 433, subpart C 
and all other applicable requirements are met.23 
CMS looks forward to continuing to work together with the states to implement DUR provisions 
within Section 1004 of the SUPPORT for Patients and Communities Act.  Questions can be 
submitted through the CMS DUR resource mailbox at CMSDUR@cms.hhs.gov.  
23 Medicaid.gov. https://www.medicaid.gov/federal-policy-guidance/downloads/smd18005.pdf 
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