FAQS ABOUT AFFORDABLE CARE ACT 
IMPLEMENTATION PART 34 AND MENTAL 
HEALTH AND SUBSTANCE USE DISORDER 
PARITY IMPLEMENTATION  
 
October 27, 2016  
 
Set out below are additional Frequently Asked Questions (FAQs) regarding implementation of 
the market reform provisions of the Affordable Care Act and the Paul Wellstone and Pete 
Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), as amended by 
the Affordable Care Act. These FAQs have been prepared jointly by the Departments of Labor 
(DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments).  
Like previously issued FAQs (available at www.dol.gov/ebsa/healthreform/index.html and 
www.cms.gov/cciio/resources/fact-sheets-and-faqs/index.html), these FAQs answer questions 
from stakeholders to help people understand the laws and benefit from them, as intended.  These 
FAQs also contain two separate requests for comments, as described below. 
 
Coverage of Preventive Services under the Affordable Care Act 
 
Public Health Service Act (PHS Act) section 2713 and its implementing regulations relating to 
coverage of preventive services1 require non-grandfathered group health plans and health 
insurance coverage offered in the individual or group market to cover without the imposition of 
any cost-sharing requirements, the following items or services: 
 
  Evidence-based items or services that have in effect a rating of A or B in the current 
recommendations of the United States Preventive Services Task Force (USPSTF) with 
respect to the individual involved, except for the recommendations of the USPSTF 
regarding breast cancer screening, mammography, and prevention issued in or around 
November 2009, which are not considered in effect for this purpose;2  
  Immunizations for routine use in children, adolescents, and adults that have in effect a 
recommendation from the Advisory Committee on Immunization Practices (ACIP) of the 
Centers for Disease Control and Prevention (CDC) with respect to the individual 
involved;  
  With respect to infants, children, and adolescents, evidence-informed preventive care and 
screenings provided for in comprehensive guidelines supported by the Health Resources 
and Services Administration (HRSA); and  
                                                            
1 See 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, 45 CFR 147.130. 
2 The USPSTF published updated breast cancer screening recommendations in January 2016. However, section 229 
of the Consolidated Omnibus Appropriations Act, 2016 requires that for purposes of PHS Act section 2713, 
USPSTF recommendations relating to breast cancer screening, mammography, and prevention issued before 2009 
remain in effect until January 1, 2018. Pub. L. 114-113.    With respect to women, evidence-informed preventive care and screenings provided for 
in comprehensive guidelines supported by HRSA, to the extent not included in certain 
recommendations of the USPSTF.3 
 
Coverage of Tobacco Cessation Interventions, Including Request for Comments 
 
In 2009, the USPSTF recommended with an A rating tobacco cessation interventions for 
non-pregnant adults who use tobacco.  On May 2, 2014, the Departments provided a safe harbor 
in FAQs stating that the Departments will consider plans and issuers to be in compliance with the 
requirement to cover tobacco use counseling and interventions based on the 2009 USPSTF 
recommendation, if for example, the plan or issuer covers without cost sharing: (1) screening for 
tobacco use; and (2) for those who use tobacco products, at least two tobacco cessation attempts 
per year.  For this purpose, covering a cessation attempt includes coverage for:  (i) four tobacco 
cessation counseling sessions of at least 10 minutes each (including telephone counseling, group 
counseling and individual counseling) without prior authorization; and (ii) all Food and Drug 
Administration (FDA)-approved tobacco cessation medications (including both prescription and 
over-the-counter medications) for a 90-day treatment regimen when prescribed by a health care 
provider, without prior authorization.4   
 
Q1:  The USPSTF updated its recommendation for tobacco cessation interventions on 
September 22, 2015.  Did the USPSTF recommendation for tobacco cessation for non-
pregnant adults change? 
Yes.  On September 22, 2015, the USPSTF extended its recommendation for non-pregnant adults 
and recommended with an A rating that clinicians ask all adults about tobacco use, advise 
them to stop using tobacco, and provide both behavioral interventions and FDA-approved 
pharmacotherapy for cessation to adults who use tobacco.  The Final Recommendation 
Statement states that [b]oth intervention types (pharmacotherapy and behavioral interventions) 
are effective and recommended; combinations of interventions are most effective, and all should 
be offered. 
 
                                                            
3 Womens Preventive Services: Required Health Plan Coverage Guidelines (HRSA Guidelines) were adopted and 
released on August 1, 2011, based on recommendations developed by the National Academy of Medicine (formerly 
Institute of Medicine). Womens preventive services recommended therein are required to be covered without cost 
sharing for plan years (or, in the individual market, policy years) beginning on or after August 1, 2012. Under the 
HRSA Womens Preventive Services Guidelines, group health plans established or maintained by religious 
employers (and group health insurance coverage provided in connection with such plans) are exempt from the 
requirement to cover contraceptive services under section 2713 of the PHS Act, as incorporated into the Employee 
Retirement Income Security Act (ERISA) and the Internal Revenue Code (the Code). 45 CFR 147.131(a). 
Additionally, accommodations for religious objections to contraception are available to group health plans 
established or maintained by certain eligible organizations (and group health insurance coverage provided in 
connection with such plans), as well as student health insurance coverage arranged by eligible organizations, with 
respect to the contraceptive coverage requirement. 
4 See Frequently Asked Questions about Affordable Care Act Implementation, Part XII, Q&A-5, available at 
https://www.dol.gov/ebsa/faqs/faq-aca19.html and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/aca_implementation_faqs19.html.   
2 
  The Final Recommendation Statement provides additional detail on individual, group, and 
telephone behavioral interventions.  It also describes the seven FDA-approved over-the-counter 
(OTC) and prescription medications for treating tobacco dependence that are now available.   
These include three types of OTC nicotine replacement products (transdermal nicotine patches, 
nicotine lozenges, and nicotine gum), two prescription-only nicotine replacement products 
(nicotine inhaler or nasal spray (Nicotrol)); and prescription-only bupropion hydrochloride 
sustained release (Zyban or generic)5 and varenicline tartrate (Chantix), which do not contain 
nicotine.6  
  
Since the issuance of the updated recommendation, stakeholders have asked the Departments to 
clarify what items and services must be provided without cost sharing to comply with the 
updated recommendation, applicable for plan years (in the individual market, policy years) 
beginning on or after one year from the date of issuance of the updated recommendation (in this 
case, plan years or policy years beginning on or after September 22, 2016). The Departments are 
seeking comments in advance of providing future guidance.  Specifically, the Departments seek 
comment on: 
 
a)  Whether all seven categories of FDA-approved pharmacotherapy interventions must be 
covered without cost sharing when prescribed by a health care provider or whether plans 
and issuers may use reasonable medical management techniques to determine which 
specific categories of FDA-approved pharmacotherapy interventions will be covered 
without cost sharing.  
 
b)  Whether plans and issuers may use reasonable medical management techniques to: 
i.  Limit the number of quit attempts per year or the duration of the interventions 
prescribed;7  
ii.  Manage the categories of FDA-approved pharmacotherapy interventions that 
may be covered without cost sharing when used in combination; or  
                                                            
5 Although Wellbutrin SR is not indicated for smoking cessation treatment, it contains the same active ingredient 
as Zyban. 
6 See Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy 
Interventions available at 
http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/tobacco-use-in-adults-and-
pregnant-women-counseling-and-interventions1. 
7 The use of reasonable medical management for benefit determinations regarding tobacco cessation 
pharmacotherapy and behavioral interventions is distinct from rules applicable to wellness programs, which require, 
among other things, that individuals eligible for the program must be given the opportunity to qualify for the reward 
under the program at least once per year.  With respect to tobacco cessation wellness programs with an initial 
outcome-based standard that an individual not use tobacco, a reasonable alternative standard for obtaining the 
reward (or a waiver of the otherwise applicable standard) must be made available for any individual who does not 
meet the initial standard based on the measurement, test, or screening.  An individual who meets the reasonable 
alternative standard is then entitled to the reward for that year, regardless of whether the individual stops using 
tobacco.  For each subsequent year, the program must again provide the individual with an opportunity to qualify for 
the reward by either meeting the initial outcome-based standard (that is, not using tobacco), or meeting a reasonable 
alternative standard, which may be the same or different than the reasonable alternative standard offered in previous 
years, regardless of whether the individual stops using tobacco. Plans and issuers cannot fail to offer a reasonable 
alternative standard in subsequent years because the individual did not cease using tobacco in past attempts to quit. 
26 CFR 54.9802-1(f)(4); 29 CFR 2590.702(f)(4); 45 CFR 146.121(f)(4) and 147.110. 
3 
  iii.  Limit the types of behavioral interventions that are covered without cost sharing.   
 
This request for comment seeks input to inform any future guidance on tobacco cessation 
coverage.  It does not supplement or clarify the USPSTF recommendation, and plans and issuers 
must offer coverage consistent with the specific recommendation made by the USPSTF. 
 
Please send comments to marketreform@cms.hhs.gov by January 3, 2017.  All comments will be 
shared among the Departments. 
 
Mental Health Parity and Addiction Equity Act of 2008  
 
Generally, the Mental Health Parity and Addiction Equity Act of 2008 requires that the financial 
requirements and treatment limitations imposed on mental health and substance use disorder 
(MH/SUD) benefits cannot be more restrictive than the predominant financial requirements and 
treatment limitations that apply to substantially all medical and surgical benefits.   
 
Disclosures with Respect to MH/SUD Benefits, Including Request for Comments 
 
The Departments have issued multiple rounds of guidance to address disclosure obligations 
under MHPAEA and other laws. The statutory MHPAEA provisions and implementing 
regulations expressly provide that a plan or issuer must disclose the criteria for medical necessity 
determinations with respect to MH/SUD benefits to any current or potential participant, 
beneficiary, or contracting provider upon request and the reason for any denial of reimbursement 
or payment for services with respect to MH/SUD benefits to the participant or beneficiary. 
However, the Departments recognize that additional information regarding medical/surgical 
benefits is necessary to perform the required MHPAEA analyses.8 Accordingly, the Departments 
have clarified in previous regulations and guidance the breadth of disclosure required, as well as 
which documents participants, beneficiaries, and their authorized representatives have a right to 
receive (and generally may find helpful) under MHPAEA, ERISA,9 and the Affordable Care 
Act.10 For example, under ERISA, plans are required to provide participants, upon request, with 
                                                            
8 See Code section 9812(a)(4), ERISA section 712(a)(4); PHS Act section 2726(a)(4).  See also 26 CFR 54.9812-
1(d); 29 CFR 2590.712(d); 45 CFR 146.136(d) and 147.160. 
9 ERISAs general disclosure obligation in section 104(b) and the accompanying disclosure regulation at 29 CFR 
2520.104b-1 provide that, for plans subject to ERISA, instruments under which the plan is established or operated 
must generally be furnished to plan participants within 30 days of request. 
10 See Code sections 9812(a)(4) and 9815; ERISA sections 104(b), 502(c), 503, 712(a)(4) and 715; PHS Act 
sections 2726(a)(4) and 2719; See also 26 CFR 54.9812-1(d)(3) and 54.9815-2719; 29 CFR 2520.104b-1, 2560.503-
1, 2590.712(d)(3) and 2590.715-2719; 45 CFR 146.136(d)(3), 147.136 and 147.160; See also 78 FR 68240, 68247 
(Nov. 13, 2013);  See also Affordable Care Implementation FAQs, Part V, Q&A-10, available at 
https://www.dol.gov/ebsa/faqs/faq-aca5.html and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/aca_implementation_faqs5.html; See also Affordable Care Act Implementation FAQs, Part XVII, Q&A-8, 
available at https://www.dol.gov/ebsa/faqs/faq-aca17.html and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-
and-FAQs/aca_implementation_faqs17.html; See also Affordable Care Act Implementation FAQs, Part XXIX, 
Q&A-12 and 13, available at https://www.dol.gov/ebsa/faqs/faq-aca29.html and 
https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-XXIX.pdf; See also 
Affordable Care Implementation FAQs, Part 31, Q&A-9, available at https://www.dol.gov/ebsa/faqs/faq-aca31.html 
and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf.    
4 
  information about the processes, strategies, evidentiary standards, and other factors used to apply 
a nonquantitative treatment limitation (NQTL)11 with respect to medical/surgical benefits and 
MH/SUD benefits under the plan.  
 
The Departments continue to receive questions and suggestions regarding disclosures with 
respect to NQTLs.  The comments include requests from various stakeholders for model forms 
that group health plan participants, beneficiaries, covered individuals in the individual market, or 
persons acting on their behalf could use to request relevant disclosures.  Commenters have also 
requested guidance on other ways in which disclosures, or the process for requesting disclosures, 
could be more uniform, streamlined, or otherwise simplified.   
 
In addition, the Departments have received requests to explore ways to encourage uniformity 
among State reviews of issuers compliance with the NQTL standards. Various stakeholders 
have stated that model forms to report NQTL information will help facilitate uniform 
implementation and enforcement of MHPAEA, and relieve some complexity that MHPAEA 
compliance poses for health insurance issuers operating in multiple States. Furthermore, other 
stakeholders have highlighted that the use of such model forms may also benefit consumers, as 
the consumers will be entitled to request the analysis performed to complete the model forms.   
 
Accordingly, the Departments request specific comments on: 
 
a)  Whether issuance of model forms that could be used by participants and their 
representatives to request information with respect to various NQTLs would be 
helpful and, if so, what content the model forms should include.  For example, is 
there a specific list of documents, relating to specific NQTLs, that a participant or his 
or her representative should request?   
 
b)  Do different types of NQTLs require different model forms?  For example, should 
there be separate model forms for specific information about medical necessity 
criteria, fail-first policies, formulary design, or the plans method for determining 
usual, customary, or reasonable charges?  Should there be a separate model form for 
plan participants and other individuals to request the plans analysis of its MHPAEA 
compliance? 
 
c)  Whether issuance of model forms that could be used by States as part of their review 
would be helpful and, if so, what content should the model form include? For 
example, what specific content should the form include to assist the States in 
determining compliance with the NQTL standards?  Should the form focus on 
specific classifications or categories of services? Should the form request information 
on particular NQTLs? 
 
                                                            
11 For more information on NQTLs, see the discussion below under the heading, Nonquantitative Treatment 
Limitations. 
5 
  d)  What other steps can the Departments take to improve the scope and quality of 
disclosures or simplify or otherwise improve processes for requesting disclosures 
under existing law in connection with MH/SUD benefits? 
 
e)  Are there specific steps that could be taken to improve State market conduct 
examinations and/or Federal oversight of compliance by plans and issuers? 
 
Please send comments to e-ohpsca-mhpaea-disclosure@dol.gov by January 3, 2017.  All 
comments will be shared among the Departments.   
 
Q2:  After having a MH/SUD benefit denied by my plan, Ive asked my plan for documents  
to show whether the plan is treating MH/SUD benefits differently than medical/surgical 
benefits, and I havent received them (or I dont know how to interpret them).  Is there a 
government agency that can help?   
 
Yes. Depending on the type of plan you have, there may be more than one government agency, 
including both Federal and State agencies, that can help you to obtain documents or understand 
the information you receive. There is a now a Parity Consumer Web Portal that can connect you 
to the appropriate agency to help you.  You can use www.hhs.gov/mental-health-and-addiction-
insurance-help to identify the agency that can help you.  While different Federal and State 
agencies may be responsible for providing oversight for and assistance with respect to different 
plans, the agencies work together to ensure that any MHPAEA violations are corrected.12 
 
In addition, if your plan is a non-grandfathered individual or group health plan and your claim 
for benefits has been denied for a reason that involves medical judgment (including if you have 
been denied a benefit and you are challenging the plans or issuers compliance with respect to 
parity in the application of its medical management techniques), you can seek external review 
after exhausting your internal appeals.13  This gives you the right to review of your claim by an 
independent review organization, without deference to the decision of your plan or issuer. This 
review will determine whether the plans or issuers decision was correct.  Your plan or issuer 
will be required to accept a favorable decision for you by the independent review organization.  
 
General information regarding MHPAEAs requirements is also available on the web at 
https://www.dol.gov/ebsa/mentalhealthparity/index.html and 
https://www.cms.gov/cciio/programs-and-initiatives/other-insurance-
protections/mhpaea_factsheet.html.  
 
                                                            
12 In fiscal years 2011 through 2015, the DOL conducted 1,515 investigations of private-sector employment-based 
health plans, and answered 1,079 customer service inquiries, related to MHPAEA. States have primary enforcement 
responsibility with respect to health insurance issuers. If a State does not have authority to enforce or does not act in 
the areas of its responsibility, HHS may enforce directly. HHS also has direct enforcement authority over non-
Federal governmental plans (those sponsored by State and local government employers). 
13 See 26 CFR 54.9815-2719(d)(1)(i)(A), 29 CFR 2590.715-2719(d)(1)(i)(A), and 45 CFR 147.136(d)(1)(i)(A), 
providing that a plans or issuers determination of whether it is complying with the MHPAEAs NQTL provisions 
involves medical judgment and, therefore, related adverse benefit determinations are eligible for external review. 
6 
  Financial Requirements and Quantitative Treatment Limitations  
   
A financial requirement (such as a copayment or coinsurance) or quantitative treatment 
limitation (such as a day or visit limit)14 is considered to apply to substantially all 
medical/surgical benefits in a classification if it applies to at least 2/3 of all medical/surgical 
benefits in the classification.  If it does not apply to at least 2/3 of medical/surgical benefits, it 
cannot be applied to MH/SUD benefits in that classification. If it does apply to at least 2/3 of 
medical/surgical benefits, the level (such as 80% or 70% coinsurance) of the quantitative limit 
that may be applied to MH/SUD benefits in a classification may not be more restrictive than the 
predominant level that applies to medical/surgical benefits (defined as the level that applies to 
more than one half of medical/surgical benefits subject to the limitation in the classification).  In 
performing these calculations, the determination of the portion of medical/surgical benefits 
subject to the quantitative limit is based on the dollar amount of all plan payments for 
medical/surgical benefits in the classification expected to be paid under the plan for the plan 
year. The MHPAEA regulations provide that any reasonable method may be used to determine 
the dollar amount of all plan payments for the substantially all and predominant analyses.15   
 
Q3:  If a group health plan or health insurance issuer does not have sufficient claims data 
to do either the MHPAEA substantially all or predominant analyses, what data can the 
plan or issuer use to conduct the analyses? 
 
In general, if a group health plan or issuer has sufficient claims data for a reasonable projection 
of future claims costs for the substantially all or predominant analyses as described above, such 
claims data should be used for these analyses.  An issuers or third party administrators broader 
book of business should not be used for the analysis, as the broader book of business includes 
many plans that may have benefit designs that bear little resemblance to the specific group health 
plan for which the MHPAEA analysis is being conducted.  In certain circumstances, however, 
there may be insufficient reliable claims data for a group health plan, in which case the analyses 
will require utilizing reasonable data from outside the group health plan.   
 
Under the Departments MHPAEA regulations, group health plans and issuers must use a 
reasonable method for the substantially all and predominant analyses, which includes using 
reasonable data to produce reasonable projections.  Group health plans and issuers should not use 
claims data from an issuers or third party administrators entire book of business in an 
unreasonable manner to calculate the amount of a particular group health plans or issuers 
payments under MHPAEA.  A plan or issuer must always use appropriate and sufficient data to 
perform the analysis in compliance with applicable Actuarial Standards of Practice.  For 
example, if there is not enough claims data, a group health plan significantly changed its benefit 
package, a group health plan experienced a significant workforce change that would impact 
claims costs, or a group health plan (or the plan design) is new, using only group health plan data 
also may be unreasonable. 
 
                                                            
14 For ease of readability, such financial requirements or quantitative treatment limits are referred to in this 
document simply as quantitative limits. 
15 See 26 CFR 54.9812-1(c)(3)(i)(E); 29 CFR 2590.712(c)(3)(i)(E); and 45 CFR 146.136(c)(3)(i)(E) and 147.160. 
7 
  Accordingly, the Departments clarify that, for large group market and self-insured group health 
plans, a group health plan or issuer must consider group health plan-level claims data to perform 
the substantially all and predominant analyses and must rely on such data if it is credible to 
perform the required projections. Similarly, for small group and individual market plans, an 
issuer must consider plan-level (as opposed to the product-level) claims data to perform the 
substantially all and predominant analyses, as such terms are defined in 45 CFR 144.103, and 
must rely on such data if it is credible to perform the required projections.16  However, if an 
actuary who is subject to and meets the qualification standards for the issuance of a statement of 
actuarial opinion in regard to health plans in the United States,17 including having the necessary 
education and experience to provide the actuarial opinion, determines that a group health plan or 
issuer does not have sufficient data at the plan or product level for a reasonable projection of 
future claims costs for the substantially all or predominant analyses, the group health plan or 
issuer should utilize other reasonable claims data to make a reasonable projection to conduct 
actuarially-appropriate analyses.  Data from other similarly-structured products or plans with 
similar demographics may be utilized for the analyses if actuarially appropriate.  In addition, to 
the extent possible, the claims data should be customized to reflect the characteristics of the 
group health plan to which the substantially all and predominant analyses are being applied.     
 
As part of using a reasonable method to make these projections, plans and issuers should 
document the assumptions used in choosing a data set and making projections. Furthermore, as 
stated in the preamble to the final regulations, a plan or issuer is not required to perform the 
parity analysis each plan year unless there is a change in plan benefit design, cost-sharing 
structure, or utilization that would affect a financial requirement or treatment limitation within a 
classification (or sub-classification).18 
 
Nonquantitative Treatment Limitations 
 
MHPAEA defines treatment limitations as limits on the scope or duration of treatment, such as 
limits based on the frequency of treatment, number of visits, or days of coverage.  The 
regulations apply different tests to assess parity for two types of treatment limitations: 
quantitative treatment limitations, as discussed above, and NQTLs.     
 
With regard to any NQTL, the MHPAEA regulations provide that a plan or issuer may not 
impose an NQTL with respect to MH/SUD benefits in any classification19 unless, under the 
                                                            
16 45 CFR 144.103 generally defines product as a discrete package of health insurance coverage benefits offered 
using a particular product network type within a service area, and plan as the pairing of the health insurance 
coverage benefits under the product with a particular cost-sharing structure, provider network, and service area.  In 
this context, the term plan is not synonymous with the term group health plan. 
17 The U.S. Qualification Standards apply to members of the five U.S.-based organizations who issue Statements of 
Actuarial Opinion in the United States.  The organizations are the American Academy of Actuaries, American 
Society of Pension Professional and Actuaries College of Pension Actuaries, Casualty Actuarial Society, Conference 
of Consulting Actuaries, and Society of Actuaries. 
18 See 78 FR 68243. 
19 The six classifications of benefits are inpatient, in-network; inpatient, out-of-network; outpatient, in-network, 
outpatient, out-of-network; emergency care; and prescriptions drugs. In addition, sub-classifications are permitted 
for office visits, separate from other outpatient services, as well as for a plan or coverage with multiple network 
tiers. 26 CFR 54.9812-1(c)(2)(ii) and (c)(3)(iii);  29 CFR 2590.712(c)(2)(ii) and (c)(3)(iii); and 45 CFR 
 
8 
  terms of the plan as written and in operation, any processes, strategies, evidentiary standards, or 
other factors used in applying the NQTL to MH/SUD benefits in the classification are 
comparable to, and are applied no more stringently than, the processes, strategies, evidentiary 
standards, or other factors used in applying the limitation to medical/surgical benefits in the same 
classification.20   
 
The regulations provide an illustrative, non-exhaustive list of NQTLs that plans and issuers 
commonly use.  These NQTLs include, among other things: 
 
  Medical management standards limiting or excluding benefits based on medical necessity 
or medical appropriateness, or based on whether the treatment is experimental or 
investigative;  
  Formulary design for prescription drugs;  
  For plans with multiple network tiers (such as preferred providers and participating 
providers), network tier design;  
  Standards for provider admission to participate in a network, including reimbursement 
rates;  
  Plan methods for determining usual, customary, and reasonable charges;  
  Refusal to pay for higher-cost therapies until it can be shown that a lower-cost therapy is 
not effective (also known as fail-first policies or step therapy protocols);  
  Exclusions based on failure to complete a course of treatment; and  
  Restrictions based on geographic location, facility type, provider specialty, and other 
criteria that limit the scope or duration of benefits for services provided under the plan or 
coverage.21  
 
Other examples of NQTLs include limitations on inpatient services for situations where a 
participant is a threat to self or others, exclusions for court-ordered and involuntary holds when 
the included care would otherwise be considered medically necessary, service coding, exclusions 
for services provided by clinical social workers, network adequacy, and prior notification 
requirements.22 
 
DOL, in conjunction with HHS, released a list of example NQTLs that are subject to the parity 
requirements in Warning Signs  Plan or Policy Non-Quantitative Treatment Limitations 
(NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance.23 
These examples of NQTLs should be evaluated to determine whether or not they comply with 
parity in the context of a specific plan or coverage.  Provided the plan or issuer can demonstrate 
that, both under the terms of the plan as written and in operation, the processes, strategies, 
                                                                                                                                                                                                
146.136(c)(2)(ii) and (c)(3)(iii) and 147.160. 
20 See 26 CFR 54.9812-1(c)(4), 29 CFR 2590.712(c)(4), and 45 CFR 146.136(c)(4) and 147.160. 
21 See 26 CFR 54.9812-1(c)(4)(ii); 29 CFR 2590.712 (c)(4)(ii); and 45 CFR 146.136(c)(4)(ii) and 147.160. 
22 See also 78 FR 68240, 68246 (Nov. 13, 2013). 
23 Available at https://www.dol.gov/sites/default/files/ebsa/laws-and-regulations/laws/mental-health-parity/warning-
signs-plan-or-policy-nqtls-that-require-additional-analysis-to-determine-mhpaea-compliance.pdf and 
https://www.cms.gov/CCIIO/Resources/Regulations-and-
Guidance/Downloads/MHAPEAChecklistWarningSigns.pdf.  
9 
  evidentiary standards, or other factors used to apply an example NQTL to MH/SUD benefits in 
the classification are comparable to, and are applied no more stringently than, the processes, 
strategies, evidentiary standards, or other factors used to apply the limitation to medical/surgical 
benefits in the same classification, the NQTL would not violate MHPAEA. 
 
As noted above, the Departments regulations identify medical management standards as a type 
of NQTL.  The regulations further provide that a plan or issuer may consider a wide array of 
factors in designing medical management techniques for both MH/SUD benefits and 
medical/surgical benefits, such as cost of treatment; high cost growth; variability in cost and 
quality; elasticity of demand; provider discretion in determining diagnosis, or type or length of 
treatment; clinical efficacy of any proposed treatment or service; licensing and accreditation of 
providers; and claim types with a high percentage of fraud.24  Based on application of these or 
other factors in a comparable fashion, a medical management standard, such as a requirement to 
obtain prior authorization, may be required for some (but not all) MH/SUD benefits, as well as 
for some (but not all) medical/surgical benefits.  The NQTL analysis does not focus on whether 
the final result is the same; instead, compliance depends on parity in application of the 
underlying processes and strategies. Among other things, there should not be arbitrary or 
discriminatory differences in how a plan or issuer applies those processes and strategies to 
medical/surgical benefits as compared to MH/SUD benefits. 
 
Q4:  Prior to authorizing admission to an inpatient, in-network facility for a mental health 
condition, my group health plan requires that a plan representative examine the individual 
in person to determine whether inpatient care is medically necessary.  For all medical and 
surgical inpatient, in-network admissions, my plan also requires prior authorization but it 
is conducted over the phone without an in-person examination.  Is this in-person prior 
authorization requirement for mental health inpatient admissions permissible? 
 
No.  The plan is imposing a prior authorization NQTL more stringently with respect to inpatient 
mental health benefits than to inpatient medical/surgical benefits.  While some differences in 
prior authorization practices with respect to individual conditions or treatments might be 
permissible based on recognized clinically appropriate standards of care, the MHPAEA 
regulations do not permit a plan or issuer to apply stricter NQTLs to all benefits for mental 
health conditions in a classification than those applied to all medical/surgical benefits in the same 
classification.  In this case, in order to receive prior authorization for any inpatient, in-network 
mental health benefits, a participant must undergo an in-person examination whereas prior 
authorization may be obtained more easily and quickly over the phone for any inpatient, in-
network medical/surgical benefits.  Accordingly, the plans in-person prior authorization 
requirement for these mental health benefits does not comply with MHPAEA. 
 
Q5:  Before authorizing coverage for inpatient treatment for a substance use disorder, my 
plan requires that I first enroll in an intensive outpatient program.  My plan applies 
similar requirements to medical/surgical benefits.  However, unlike medical/surgical 
benefits for which the requirements can be satisfied by programs offered in my geographic 
area, no intensive outpatient programs are available to treat my substance use disorder in 
                                                            
24 See 78 FR 68240, 68241, 68246 (Nov. 13, 2013). 
10 
  my geographic area.  I alerted my plan that no outpatient program is available in my 
geographic area, but the plan indicated that there are no exceptions.  Is this permissible? 
 
No.  The requirement to try an intensive outpatient program before being admitted for inpatient 
treatment is a type of NQTL, often referred to as a fail-first or step-therapy requirement.  The 
Departments regulations require that a plan or insurance issuer may not impose an NQTL with 
respect to MH/SUD benefits in a benefit classification unless, under the terms of the plan as 
written and in operation, the processes, strategies, evidentiary standards, or other factors used in 
applying the NQTL are comparable and applied no more stringently with respect to MH/SUD 
benefits than with respect to medical/surgical benefits in the same classification.  
 
If a fail-first requirement that applies to MH/SUD benefits includes a condition that an individual 
cannot reasonably satisfy (in this case, a condition to first attempt an intensive outpatient 
program, although there are no programs available), and the lack of access to programs necessary 
to satisfy the requirement exists only with respect to MH/SUD benefits, then the fail-first 
requirement is, in operation, applied more stringently with respect to MH/SUD benefits than 
medical/surgical benefits. 
 
Because the Departments' prior guidance did not address the application of fail-first requirements 
in situations involving lack of access and may have reasonably been interpreted in an alternative 
manner, the Departments will apply this clarifying guidance for plan years (or, in the individual 
market, policy years) beginning on or after March 1, 2017. 
 
Medication Assisted Treatment for Opioid Use Disorder 
 
Medication Assisted Treatment (MAT) is the use of medication in combination with behavioral 
health services to treat substance use disorders, including opioid use disorder.  There are 
currently three medications approved by the FDA for use in detoxification or maintenance 
treatment for opioid use disorder:  (1) methadone, (2) buprenorphine, and (3) naltrexone.25  On 
April 20, 2016, the Departments issued Affordable Care Act Implementation FAQs Part 31, 
addressing, among other things, whether or not MHPAEA applies to any benefits a plan may 
offer for MAT for opioid use disorder.  The Departments reiterated that the regulations 
implementing MHPAEA define substance use disorder benefits as benefits with respect to 
items or services for substance use disorders, as defined under the terms of the plan or health 
insurance coverage and in accordance with applicable Federal and State law.  Additionally, any 
condition defined by the plan or coverage as being or as not being a substance use disorder must 
be defined consistently with generally recognized independent standards of current medical 
practice.  Opioid use disorder is a type of substance use disorder, under generally recognized 
independent standards of current medical practice, and therefore MAT is a substance use 
disorder benefit within the meaning of the term as defined by MHPAEA. 
 
                                                            
25 See Center for Substance Abuse Treatment, Medication-Assisted Treatment for Opioid Addiction in Opioid 
Treatment Programs. Substance Abuse and Mental Health Services Administration (US); 2005. (Treatment 
Improvement Protocol (TIP) Series, No. 43.) Chapter 1. Introduction. 
11 
  Q6:  My plan requires prior authorization from the plans utilization reviewer that 
buprenorphine is medically necessary for the treatment of my opioid use disorder.  The 
plan says the prior authorization requirement is imposed due to safety risks associated with 
buprenorphine. Although there are prescription drugs to treat medical/surgical conditions 
that have similar safety risks, my plan does not impose similar prior authorization 
requirements on those drugs.  Is this permissible? 
 
No.  A plan may impose an NQTL, including a prior authorization requirement for 
buprenorphine, if, under the terms of the plan as written and in operation, the processes, 
strategies, evidentiary standards, and other factors considered by the plan in implementing its 
prior authorization requirement with respect to buprenorphine to treat an opioid use disorder are 
comparable to, and applied no more stringently than, those used in applying its prior 
authorization requirement with respect to medical/surgical benefits in the prescription drug 
classification under MHPAEA.   
 
In this scenario, the plan imposes the prior authorization requirement due to stated safety 
concerns.  However, the prior authorization requirement is applied more stringently to 
buprenorphine when used to treat opioid use disorder than it is applied to prescription drugs with 
similar safety risks to treat medical/surgical conditions.  Accordingly, the plans prior 
authorization requirement on buprenorphine does not comply with MHPAEA. 
 
Q7:  My plan requires that I meet specific non-pharmacological fail-first requirements (for 
example, that I have tried counseling alone, failed at recovery, and resumed substance use) 
before it will authorize coverage for buprenorphine to treat my opioid use disorder.  While 
comparable evidentiary standards and other factors indicate that similar fail-first 
requirements could be imposed on certain prescription drugs covered by my plan for 
medical/surgical conditions, the plan does not impose fail-first requirements in these 
instances.  Is this permissible? 
 
No.  A fail-first requirement is an NQTL that must comply with the requirements of MHPAEA.  
A plan or issuer cannot impose a fail-first requirement on coverage for buprenorphine for opioid 
use disorder unless, under the terms of the plan as written and in operation, the processes, 
strategies, evidentiary standards, and other factors considered by the plan in designing and 
imposing this fail-first requirement are comparable to, and applied no more stringently than the 
processes, strategies, evidentiary standards, or other factors used in applying fail-first 
requirements to medical/surgical benefits in the prescription drug classification under MHPAEA.   
 
In this case, the plan is imposing a non-pharmacological requirement that the individual fail first 
at recovery with counseling alone before the plan will authorize coverage of benefits for 
buprenorphine.  While comparable evidentiary standards and other factors indicate that similar 
fail-first requirements could be appropriate before authorizing coverage for certain other 
prescription drugs covered by the plan for medical/surgical conditions, the plan does not in fact 
impose fail-first requirements in any of these instances.  Accordingly, the fail-first requirement 
imposed on buprenorphine is an NQTL that the plan applies more stringently to a substance use 
disorder condition than medical/surgical conditions.  This disparity violates MHPAEA. 
 
12 
  Q8:  My group health plan states that it follows nationally-recognized treatment guidelines 
for setting prior authorization requirements for prescription drugs, but requires prior 
authorization for my buprenorphine/naloxone combination at each refill (every 30 days) 
for my opioid use disorder, which is not consistent with nationally-recognized treatment 
guidelines. Is this permissible? 
 
No.  In setting the NQTL of prior authorization for the substance use disorder medication, 
buprenorphine/naloxone, a plan or issuer must apply comparable processes, strategies, 
evidentiary standards, and other factors no more stringently to buprenorphine/naloxone than 
those applied to medical/surgical medications. The plan states that it follows nationally-
recognized guidelines.  However, these guidelines,26 such as the American Society of Addiction 
Medicine (ASAM) national practice guidelines,27 do not support 30-day authorization practices 
for buprenorphine/naloxone. Furthermore, the plan does not deviate from nationally-recognized 
treatment guidelines when establishing prior authorization requirements for any prescription 
drugs to treat medical/surgical conditions.  Accordingly, although the plan asserts that its process 
of setting the NQTL of prior authorization -- following nationally-recognized treatment 
guidelines -- is comparable as written, in operation, the plans process departs from and provides 
less coverage than recommended under nationally-recognized treatment guidelines for 
buprenorphine/naloxone, in violation of MHPAEA.  
 
However, as an alternative to simply mirroring nationally-recognized treatment guidelines, many 
plans and issuers use Pharmacy and Therapeutics (P&T) committees in deciding how to cover 
prescription drugs and evaluating whether to follow or deviate from nationally-recognized 
treatment guidelines for setting the prior authorization requirements.  The Departments note that 
while the use of P&T committees to inform prior authorization requirements for prescription 
drugs in this manner may not violate MHPAEA per se, these processes must also comply with 
MHPAEAs NQTL standard in operation. For example, if the plan deviates from nationally-
recognized treatment guidelines for buprenorphine/naloxone based on P&T committee reports, 
then use of the P&T committee would be evaluated for compliance with MHPAEAs NQTL 
requirements (for example, by evaluating whether the P&T committee is comprised of 
comparable experts for MH/SUD conditions, as compared to the experts for medical/surgical 
conditions, and how such experts evaluated nationally-recognized treatment guidelines in setting 
prior authorization for medications for both MH/SUD and medical/surgical conditions).   
 
Under nationally-recognized treatment guidelines, authorization for a prescription drug intended 
for extended use to treat a chronic MH/SUD or medical/surgical condition is often appropriate at 
six or 12 months; as a result, even in a plan that uses a P&T committee to set standards, an 
authorization of buprenorphine/naloxone that is limited to 30 days could be inconsistent with 
authorization practices for chronic medical/surgical conditions.  Therefore, in such a plan, absent 
comparable restrictions on medications for medical/surgical conditions, this 30-day limit is a 
                                                            
26 A current summary of these treatment guidelines is available at: https://aspe.hhs.gov/report/review-medication-
assisted-treatment-guidelines-and-measures-opioid-and-alcohol-use.  
27 The current ASAM national practice guideline for the use of medication in the treatment of addiction involving 
opioid use is available at: www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-
national-practice-guideline-supplement.pdf. 
13 
  red flag or warning sign that the plan may be imposing an impermissible NQTL. 28  Unless 
the plan provides evidence from P&T committee reports regarding the 30-day limit to 
substantiate its compliance, the plans prior authorization requirement on buprenorphine would 
not be in compliance with MHPAEA.   
   
Court-Ordered Treatment 
 
Plans and policies may sometimes exclude coverage of court-ordered treatment.   MHPAEA 
prohibits separate treatment limitations in a plan or coverage that are applicable only with respect 
to MH/SUD benefits.29   It has come to the Departments attention that there are questions 
regarding whether exclusions for court-ordered treatment are subject to MHPAEA, and how the 
MHPAEA analysis would apply. 
 
Q9:  Is an exclusion of court-ordered treatment for substance use disorders permissible 
under MHPAEA for a plan or coverage that does not exclude court-ordered treatment for 
medical/surgical conditions? 
  
No, if the exclusion applies only to court-ordered treatment for substance use disorders.  
MHPAEA prohibits separate treatment limitations in a plan or coverage that are applicable only 
with respect to MH/SUD benefits.   
 
Alternatively, plans often apply medical necessity criteria to all treatment requests, and may do 
so in the case of court-ordered treatment for substance use disorders, if that is consistent with 
MHPAEAs parity requirements for NQTLs.  If the plan determines that court-ordered treatment 
is not medically necessary and denies a claim for benefits, then an individual would be informed 
of his or her right to appeal and request external medical necessity review, consistent with the 
Departments regulations for claims, appeals, and external review.30   
 
 
                                                            
28 For other warning signs, see the publication Warning Signs- Plan or Policy Non-Quantitative Limitations 
(NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance, available at: 
https://www.dol.gov/sites/default/files/ebsa/laws-and-regulations/laws/mental-health-parity/warning-signs-plan-or-
policy-nqtls-that-require-additional-analysis-to-determine-mhpaea-compliance.pdf and 
https://www.cms.gov/CCIIO/Resources/Regulations-and-
Guidance/Downloads/MHAPAEAChecklistWarningSigns.pdf. 
29 See ERISA section 712(a)(3)(ii); PHS Act section 2726(a)(3)(ii); Code section 9812(a)(3)(ii). 
30 See 26 CFR 54.9815-2719; 29 CFR 2590.7152719; and 45 CFR 147.136 and 147.160. 
14