Docket: CMS-2009-0040 

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

Comment On: CMS-2009-0040-0048 

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

Addiction Equity Act of 2008 

Document: CMS-2009-0040-DRAFT-0116 

PA 

Submitter Information 

Name: Elisabeth Houtsmuller 

Address: 

Lansdale PA, PA, 19446 

Organization: Hayes Inc. 

General Comment 

We appreciate the opportunity to comment on the regulations for the Paul Wellstone and Pete 

Domenici Mental Health Parity and Addiction Equity Act of 2008. 

• We propose that health plans be required to use objective evidence-based assessments of the 

safety, efficacy, and comparative effectiveness of diagnostic tools and treatments to support 

conclusions about medical necessity, fail-first and step therapy protocols and standards of care, 

and in developing coverage policies for mental and behavioral health tests and treatments. 

• We propose that health plans be required to use assessments performed by an independent 

outside party in order to prevent a situation in which plans may circumvent the intent of the law 

by using internal panels or consultants that are not independent. 

Please see also the attached file. 

Sincerely, 

Elisabeth J. Houtsmuller, Ph.D. 

Susan A. Levine, DVM, Ph.D. 

Hayes, Inc. 

PUBLIC SUBMISSION 

As of: May 04, 2010 

Received: May 03, 2010 

Status: Draft 

Category: Private Industry - Health Care

Tracking No. 80ae5f1d 

Comments Due: May 03, 2010 

Submission Type: Web

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Attachments 

CMS-2009-0040-DRAFT-0116.1: PA

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Transforming Healthcare with Evidence 

May 3, 2010 

Centers for Medicare & Medicaid Services 

Department of Health and Human Services, Attention: CMS-4140-IFC 

File Code: CMS-4140-IFC 

Dear Sir or Madam, 

We appreciate the opportunity to comment on the regulations for the Paul Wellstone and Pete Domenici 

Mental Health Parity and Addiction Equity Act of 2008. 

Hayes Inc. is an independent health technology research and consulting company that performs unbiased, 

evidence-based comparative assessments of a wide variety of medical and mental health technologies. 

Hayes is dedicated to promoting the use of evidence in decision making, policy development, and clinical 

practice, with the goal of improving health outcomes for all patients. Our worldwide clients include 

hospitals, healthcare systems, government agencies, employers, and managed care organizations. 

Hayes has developed a strong Mental and Behavioral Health division focused on comparative 

assessments of treatments and diagnostic tools for mental health and substance use disorders. Hayes has 

evaluated over 50 mental health and substance use disorder treatments and/or diagnostic treatments. 

These comparative effectiveness assessments are based on a comprehensive and critical review of the best 

available scientific evidence by a team of analysts with extensive expertise evaluating diagnostic tools 

and treatments for mental health and substance use disorders. 

We are hopeful that the elimination of differences in coverage between mental and substance abuse 

conditions and medical health conditions will realize Congress’ intent to improve patient access to 

appropriate mental health and substance use disorder services. We wish to comment on the cost 

containment measures that may be used and the process that should guide them. 

Under the new law, cost containment measures such as medical necessity criteria, fail first policies and 

step therapy protocols can be applied to addiction and mental health benefits as long as they are applied 

no more stringently than to the plan’s medical benefits, except to the extent that recognized clinically 

appropriate standards of care may permit a difference. 

The definition of ‘medical necessity’ and of specific fail-first and step therapy policies and the conditions 

under which these may apply will be key factors in the implementation of the law according to Congress’ 

intent. The process of defining these concepts is complicated by factors such as the controversy regarding 

the diagnosis of some mental health conditions (e.g., pediatric bipolar disorder) and the availability of 

multiple treatments for specific conditions (e.g., alcohol addiction, depression). Similarly, ‘recognized 

clinically appropriate standards of care’ is subject to interpretation. The process of defining these 

concepts should be transparent, objective, consistent, and based on scientific evidence. A specific 

concern in this respect is that while pharmaceutical treatments are often marketed aggressively to both 

patients and providers, psychosocial treatments, which can be equally effective for many mental and 

substance use disorders, are not typically supported by such marketing efforts. Therefore, it is essential 

that all diagnostic and treatment options be evaluated based on the best available scientific evidence, 

rather than expert opinion or industry-provided information, which can introduce bias. 
 We propose that health plans be required to use objective evidence-based assessments of the 

safety, efficacy, and comparative effectiveness of diagnostic tools and treatments to support 

conclusions about medical necessity, fail-first and step therapy protocols and standards of care, 

and in developing coverage policies for mental and behavioral health tests and treatments. 

 We propose that health plans be required to use assessments performed by an independent outside 

party in order to prevent a situation in which plans may circumvent the intent of the law by using 

internal panels or consultants that are not independent. 

We thank the Departments of Labor, Health and Human Services and Treasury for the opportunity to 

share our comments and concerns, and hope they are helpful for the successful implementation of this 

important law. Please let us know if you have any questions or if we can be of further assistance. 

Sincerely, 

Elisabeth J. Houtsmuller, Ph.D. 

Director, Mental and Behavioral Health Programs, Managing Editor 

Susan A. Levine, DVM, Ph.D. 

Vice President, Health Technology Research and Consulting, Editor-in-Chief 

Hayes, Inc.