Docket: EBSA-2009-0010 

The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 

Comment On: EBSA-2009-0010-0409 

Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and 

Addiction Equity Act of 2008 

Document: EBSA-2009-0010-DRAFT-0630 

Comment on FR Doc # 2010-2167 

Submitter Information 

General Comment 

April 29, 2010 

Submitted via Federal eRulemaking Portal: http://www.regulations.gov 

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 

PUBLIC SUBMISSION

As of: April 30, 2010 

Received: April 29, 2010 

Status: Pending_Post 

Tracking No. 80ae3e8d 

Comments Due: May 03, 2010

Submission Type: Web

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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. 

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.” 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 outof-pocket 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 

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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 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” 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-ofnetwork, outpatient in-network, outpatient out-of-network, 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 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 

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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 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, 

Michael E. Zakaras, P.h.D. 

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