April 29, 2010 

Office of Health Plan Standards and Compliance Assistance 

Employee Benefits Security Administration 

Department of Labor 

200 Constitution Avenue, NW 

Washington, DC 20210 

Attention: RIN 1210-AB30 

Centers for Medicare and Medicaid Services 

Department of Health and Human Services 

200 Independence Avenue, SW 

Washington, DC 20201 

Attention: CMS--4140—IFC 

Internal Revenue Service 

Department of the Treasury 

1111 Constitution Avenue, NW 

Washington, DC 20224 

Attention: REG-120692-09 

Re: Interim Final Rules under the Paul Wellstone and Pete Domenici Mental Health 

Parity and Addiction Equity Act of 2008; Final Rule 

To Whom It May Concern: 

I appreciate the opportunity to comment on the Interim Final Rules under the 

Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity 

Act of 2008 (MHPAEA), published in the February 2, 2010 Federal Register. 

The following comments on specific provisions in the regulations will help 

strengthen consumer protections and ensure that the implementing regulations 

reflect Congress’ intent to prohibit discriminatory limits on mental health and 

substance use conditions by employer-sponsored and other group health plans. 

Non Quantitative Treatment Limitations

In enacting the MHPAEA, Congress made clear that the goal of this new law was 

to remedy the long history of employers and insurers not providing comparable 

coverage for mental health and substance use conditions relative to the medical 

and surgical benefits they provide.1

 

1 United States House of Representatives, Committee on Education and Labor, House of Representatives 

Report No. 110-374, pt. 2 at 12 (2007). 
2

Higher co-payments, deductibles, and other cost-sharing requirements, as well as 

restrictions on the number of outpatient visits and inpatient days covered are 

only the most obvious examples of discriminatory treatment of mental health 

and substance use care. The provisions in the interim final rules describing non 

quantitative treatment limits respond to the evidence indicating mental health 

and substance use benefits have historically been much more strictly managed 

than medical and surgical benefits in ways that, were they to continue, would 

circumvent congressional intent and objectives explicitly delineated in the new 

law. 

As the interim final rules explain, the examples of the types of treatment 

limitations and financial requirements included in the statutory provisions are 

illustrative and should not be interpreted as the only treatment limitations and 

financial requirements to which parity applies under the new law. Use of the 

term “includes” in the definitions of “financial requirement” and “treatment 

limitation” makes this point clear. 

Treatment limitations are defined in the statute as including “limits on the 

frequency of treatment, number of visits, days of coverage, or other similar limits 

on the scope or duration of treatment.” 2 The non quantitative treatment 

limitations outlined in the interim final rules, including -- medical necessity 

standards, formulary design, standards for participation in provider networks, 

methods for determining usual, customary and reasonable charges, fail first and 

step therapy requirements, and exclusions based on failure to complete a course 

of treatment -- clearly fit within this category. This list of examples includes 

some of the most common methods used by health plans to inequitably limit 

mental health and substance use disorder services. 

I strongly support the provisions in the new rules clarifying that prior 

authorization requirements, fail first policies and step therapy requirements, will 

be subject to the protections of parity. Equally important for ensuring equitable 

coverage of mental health and substance use disorder benefits is requiring 

comparable standards for determining medical necessity or appropriateness as 

included in the interim final rules. 

I also strongly support applying parity to standards for provider networks 

including reimbursement rates. Offering a disproportionately limited network of 

providers for mental health and substance use disorder services compared to 

medical or surgical care undoubtedly results in inequitable limitations on 

treatment and higher financial requirements in the form of higher out-of-pocket 

 

2

See Employee Retirement Income Security Act of 1974 § 712(a)(3)(B)(iii); Public Health Service Act § 

2705(a)(3)(B)(iii); Internal Revenue Code of 1986 § 9812(a)(3)(B)(iii). 
3

costs resulting from the greater likelihood of having to go to an out-of-network 

provider. 

The regulations should require that plans provide information to consumers 

regarding the relative availability of in-network and out-of-network providers 

for each of the medical specialties in order to evaluate the adequacy of the 

networks and their equivalence. 

I also strongly support the application of parity to prohibit plans from requiring 

individuals to exhaust an employee assistance program (EAP) benefit before 

being eligible for mental health/substance use disorder benefits. Using EAPs to 

impede access only to other mental health or substance use benefits clearly 

constitutes an inequitable treatment limitation and should not be permitted. 

In addition, the standards used for determining whether a treatment is 

experimental or investigative should also be comparable and not more 

stringently applied to mental health and substance use benefits as specified in 

the interim final rules. Formulary designs and methods for determining usual, 

customary, and reasonable charges also clearly fall within the definition of 

treatment limitations and must be subject to the new parity requirements as a 

result. 

Applying the Parity Requirement to Non Quantitative Treatment Limitations

In light of the more complex task of applying parity to the non quantitative 

treatment limitations, I appreciate the additional test delineated in the parity 

regulations to specify that any processes, strategies, evidentiary standards or 

other factors used in applying these non quantitative treatment limits must be 

comparable to and applied no more stringently for mental health and substance 

use conditions than for medical and surgical benefits except to the extent that 

recognized clinically appropriate standards may permit a difference. 

I do, however, urge the agencies to provide further guidance on what is meant 

by “recognized standards of care” so as to prevent this exception from becoming 

an unmanageable loophole in this critical requirement. 

Furthermore, the statute clearly requires that all treatment limitations applicable 

to mental health or substance use benefits must be “no more restrictive than the 

predominant treatment limitations applied to substantially all medical and 

surgical benefits covered by the plan”. I urge the agencies to clarify in the 

regulations how to apply the “substantially all” and “predominant” standards to 

non quantitative treatment limitations. Without this additional clarification, 

health plans may take a highly restrictive non quantitative treatment limitation 
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that only applies to a small minority of medical/surgical benefits and apply that 

highly restrictive limitation to the majority of mental health and substance use 

disorder benefits. 

Separate Deductibles

I strongly support the provision in the interim final rules prohibiting separately 

accumulating financial requirements – including deductibles and quantitative 

treatment limits. Separate deductibles, even if they are set at equal levels, do not 

impose an equal burden on individuals with mental health or substance use 

conditions but instead an additional burden. Separately accumulating deductibles 

represent the type of discriminatory practice disadvantaging individuals in need 

of mental health or substance use treatment that Congress meant to remedy with 

enactment of MHPAEA. 

 

Moreover, the provisions in the statute prohibiting “separate cost-sharing 

requirements that are applicable only with respect to mental health or substance 

use disorder benefits”3 clearly provide statutory authority for prohibiting separate

deductibles. 

Whether and How MHPAEA Addresses Scope of Services

Comprehensive and thoughtful implementation of the parity requirement has 

led the agencies to require classification of benefits into six classes (i.e., inpatient 

in-network, inpatient out-of-network, outpatient in-network, outpatient out-ofnetwork, emergency care, and prescription drugs) to facilitate analysis of 

treatment limitations and financial requirements for comparable types of care. 

The resulting requirement that mental health and substance use condition 

services must be provided across a set of benefit classes comparable to the 

benefits provided for medical/surgical care does represent a scope of services or 

continuum of care that plans must provide on an equitable basis under the new 

parity law. 

As recognized in the interim final rules, standards for determining whether a 

service is medically necessary or too experimental are primary means of limiting 

the scope or duration of treatment and as such must be administered in an 

equitable manner in order to comply with the new parity law. Application of 

these standards certainly results in coverage of a certain scope of services or 

continuum of care. The regulations should specify that application of the parity 

requirements to treatment limitations, including medical necessity and 

evidentiary standards, should result in a scope of service for mental health and 

 

3 e.g., sec 712 of ERISA, subsection (a)(3)(A)(i)
5

substance use disorders that is comparable to a medical/surgical continuum of 

care. 

Need for Further Clarification on Disclosure Requirements Regarding Medical 

Necessity and Coverage Denials

With regard to medical necessity, the regulations should— 

 Set timeframes for disclosure of medical necessity criteria; 

 Include a detailed description of appeal and enforcement mechanisms 

with the disclosure of the medical necessity criteria; 

 Clarify that disclosure of the criteria used to make medical necessity 

determinations must include the standards used to determine medical 

necessity judgments (e.g., standard of practice, strength of the evidence 

base, definition of medical conditions); and 

 Make available to beneficiaries, upon request, the standards used to assess 

medical necessity for medical and surgical benefits. 

With regard to coverage denials, I am pleased to see the new parity regulations 

incorporate the requirements from the regulations under Employee Retirement 

Income Security Act (ERISA) directing, for example, that disclosure of reasons 

for denial must be automatic and free of charge, set timeframes for these 

disclosures, and outline the process for appealing coverage determinations. I 

urge the agencies to extend this requirement to all plans (not just ERISA plans) 

instead of merely recommending that all plans comply with these requirements. 

Need for Further Clarification on Cost Exemption

The regulations should clarify that assessment of whether a plan qualifies for a 

cost exemption must be determined on a retrospective basis and based on real 

experience with increased cost instead of hypothetical costs. 

The regulations should provide guidance on the evidence that would be required 

to attribute any cost increase to the provision of equitable services as opposed to 

other market conditions. 

Defining Mental Health and Substance Use Disorder Benefits

I also support steps taken in the interim final rules to prevent plans from 

misclassifying mental health or substance use disorder benefits in order to avoid 
6

having to comply with the parity law. Requiring that mental health and 

substance use disorder benefits must be defined in accordance with generally 

recognized independent standards of current medical practice (including the 

Diagnostic and Statistical Manual of Mental Disorders, the International 

Classification of Diseases and state guidelines) should help to prevent any 

attempts to undermine application of the critical consumer protections called for 

by the parity law. 

Generalist v. Specialist Classifications

In addition, I support the provision in the preamble to the interim final rules 

directing that separate classifications of generalists and specialists will not be 

permitted in determining the predominant financial requirement (e.g., co-pays or 

co-insurance) for medical and surgical benefits compared to mental health and 

substance use disorder benefits. This important component to the parity analysis 

will again help improve access to mental health care and addiction treatment by 

keeping co-pay and co-insurance levels comparable to general health care 

providers. I note that this direction to plans not to classify mental health and 

substance use provider in a group of specialty providers was only discussed in 

the preamble but not included in the actual regulations. I urge you to include 

this important provision in the interim final rules. 

 

Thank you for your consideration of my views. 

Sincerely, 

Maureen Boyle