Docket: EBSA-2009-0010 

Request for Information Regarding the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction 

Equity Act of 2008 

Comment On: EBSA-2009-0010-0001 

Request for Information Regarding the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction 

Equity Act of 2008 

Document: EBSA-2009-0010-DRAFT-0089 

Comment on FR Doc # E9-9629 

Submitter Information 

Name: Laurence M Hirshberg 

Address: 

38 Paine Rd 

Cumberland, RI, 02864 

Email: lhirshberg@neurodevelopmentcenter.com 

Phone: 401-351-7779 

Organization: Brown University/The NeuroDevelopment Center 

General Comment 

RE: Comments regarding Regulatory Guidance USCG-2007-27022 page 19157, II B 

specific areas 1 and 4, specifically with reference to the requirement that “the 

treatment limitations (including limits on the frequency of treatment, number of 

visits, days of coverage, or other similar limits on the scope or duration of 

treatment) applicable to such mental health or substance use disorder benefits 

are no more restrictive than the predominant treatment limitations applied to 

substantially all medical and surgical benefits covered by the plan.” 

Introduction 

I am a clinical psychologist and serve on the clinical faculty in the Department 

of Psychiatry and Human Behavior of the Brown University School of Medicine. I 

have been in full time practice for more than 20 years, working with children 

and adults with neurodevelopmental and neuropsychiatric problems. I have 

published and presented on numerous topics in psychology in journals and at 

national and international conferences. 

I am a strong advocate of evidence based practice, and pursue this 

comprehensively in the clinic I direct. I summarize the relevant research on 

all forms of treatment available for the particular problem a client presents 

PUBLIC SUBMISSION 

As of: May 26, 2009 

Received: May 24, 2009 

Status: Pending_Post 

Tracking No. 809af786 

Comments Due: May 28, 2009

Submission Type: Web
with and discuss the profile of advantages and disadvantages of each. I offer 

for every client to provide them with published reviews of the relevant 

research. I also gather treatment outcome data for every client using well 

established measures, and provide these data to the client and to all of the 

treating professionals involved with this client. So I am acutely aware of the 

importance of the evidence base in providing competent care. 

Indeed, my focus on the importance of evidence based practice has resulted in 

increasing awareness of the minimal evidence base for much of medical surgical 

practice, and of the complete absence of parity between limitations placed on 

mental health and substance abuse treatment in comparison to medical surgical 

treatment allegedly in the name of evidence based practice. 

The predominant scientific review criteria in medical surgical practice 

Much more stringent and restrictive criteria are employed in scientific review 

of mental health and substance abuse treatments than are met for the 

preponderance of medical surgical treatment. The result is an egregious 

violation of the principles of parity and equality. 

To give just one of many possible examples: The Journal of the American Medical 

Association (JAMA) recently published a review of the evidence base supporting 

the joint cardiovascular practice guidelines of the American College of 

Cardiology (ACC) and the American Heart Association (AHA). (Tricoci P, Allen J, 

Kramer J, Califf R, Smith S (2008) Scientific Evidence Underlying the ACC/AHA 

Clinical Practice Guidelines, JAMA, February 25, 2009—Vol 301, No.8 ) 

In this review, the 16 current practice guidelines that reported levels of 

scientific evidence were reviewed and the degree of scientific support for 2711 

specific practice recommendations was assessed and paced into one of three 

categories: 

• Level of evidence A: recommendation based on evidence from multiple randomized 

trials or meta-analyses 

• Level of evidence B: recommendation based on evidence from a single randomized 

trial or nonrandomized studies 

• Level of evidence C: recommendation based on expert opinion, case studies, or 

standards of care. 

The results show that only 11% of the 2711 recommendations are based on level of 

evidence A – multiple randomized trials. Of the remaining recommendations, 41% 

are based on level of evidence B – a single randomized trial or non-randomized 

studies, and 48% are based on level C – expert opinion or case studies. 

This makes it clear that at least in cardiology, medical surgical practice 

guidelines are very rarely based on the highest level of scientific evidence, 

and that the actual scientific review criteria currently in use in the 

predominant body of medical surgical practice, at least in cardiology, are less 

restrictive and include anecdotal evidence (expert opinion), case studies, 

non-randomized studies, or a single randomized trial. 

More restrictive scientific review criteria in mental health and substance abuse 

treatment 

However, virtually all health insurers employ much more restrictive criteria in 

their scientific review of treatment practices in mental health and substance 

abuse. This is a clear violation of the principle of parity and equality, since 

it results in much more severe limitations in coverage of treatment in mental 

health and substance abuse care. 

An example to contrast with the standard in cardiology: EEG biofeedback, also 

called neurofeedback. EEG biofeedback is an approach in several areas of mental 

health and substance abuse treatment that is safe, non-invasive, widely 
available, and has an ample evidence base in over thirty years of clinical 

practice and hundreds of published studies. Like the research supporting 

cardiovascular treatment, EEG biofeedback research includes randomized 

controlled studies as well as non-randomized, open trials and case studies. 

However, most insurers do not cover EEG biofeedback services, usually based on 

claims of insufficient scientific evidence of efficacy of this treatment. This 

is the case with most health insurers active in our geographic area, including 

Blue Cross Blue Shield of RI and Massachusetts, Tufts Health Plan, Harvard 

Pilgrim Health Plan, and Aetna Behavioral Health. 

This represents a limitation in coverage in mental health care that is not 

present in medical and surgical benefits, since many medical treatments that are 

routinely covered have substantially less research evidence of efficacy than 

biofeedback. In this way, more restrictive scientific review criteria are 

employed for limiting the coverage of biofeedback in mental and behavioral 

health care than those employed for review of many medical procedures. This 

appears to be a violation of the requirements of parity under MHPAEA. 

A review of the research on the efficacy of EEG biofeedback was published in 

2005 in Child and Adolescent Psychiatric Clinics of North America, a well 

respected psychiatric journal. This review employed criteria for judging the 

degree of scientific evidence of treatment efficacy that were employed by the 

American Academy of Child and Adolescent Psychiatry, the child psychiatry 

professional organization, for developing practice guidelines for the treatment 

of ADHD. These criteria specified four levels: 

• ‘‘Minimal Standards’’ [MS] are recommendations that are based on substantial 

empirical evidence (such as well-controlled, double-blind trials) or 

overwhelming clinical consensus. Minimal standards are expected to apply more 

than 95% of the time. i.e., in almost all cases. When the practitioner does not 

follow this standard in a particular case, the medical record should indicate 

the reason. 

• ‘‘Clinical Guidelines’’ [CG] are recommendations that are based on limited 

empirical evidence (such as open trials, case studies) and/or strong clinical 

consensus. Clinical guidelines apply approximately 75% of the time. These 

practices should always be considered by the clinician, but there are exceptions 

to their applications. 

• ‘‘Options’’ [OP] are practices that are acceptable but not required. There may 

be insufficient empirical evidence to support recommending these practices as 

minimal standards or clinical guidelines. In some cases they may be appropriate, 

but in other causes they should be avoided. If possible, the practice parameter 

will explain the pros and cons of these options. 

• ‘‘Not Endorsed’’ [NE] refers to practices that are known to be ineffective or 

contraindicated. 

Based on these scientific review criteria, as advanced by the chief child 

psychiatry professional organization, EEG biofeedback was considered to be meet 

the review criteria as a “clinical guideline for treatment of ADHD, seizure 

disorders, anxiety (eg, obsessive-compulsive disorder, GAD, posttraumatic stress 

disorder, phobias), depression, reading disabilities, and addictive disorders. 

This finding suggests that EBF always should be considered as an intervention 

for these disorders by the clinician. “ 

This review was published in 2005; many additional studies demonstrating the 

efficacy of EEG biofeedback have been published since that time. It is without 

question that there is a substantial research evidence base of documenting the 

effectiveness of this very safe and widely available treatment in a range of 

very difficult to treat mental and behavioral health disorders. 

Perhaps more importantly, EEG biofeedback shows substantial efficacy in many 

conditions that are quite resistant to treatment by other means. For example, 

seven studies have been completed evaluating the efficacy of EEG biofeedback for 
autism spectrum disorders. All have shown substantial benefit in social, 

emotional, and executive function, in several studies after only 20 sessions, or 

ten weeks of treatment. I have been specializing in clinical work with this 

group for more than 20 years. I have seen at very close hand virtually al of the 

treatment techniques in use. EEG biofeedback more consistently results in more 

rapid progress than any other form of intervention I know. The same is true for 

the use of EEG biofeedback in the treatment of PTSD. 

Indeed, using the scientific review criteria that predominate in 

medical/surgical practice in cardiology, EEG biofeedback meets the predominant 

criteria for treatment of the following disorders: 

• ADHD 

• Autism spectrum disorders 

• Substance abuse/addictions 

• Generalized anxiety disorder 

• Obsessive compulsive disorder 

• PTSD 

• Phobias 

• Panic disorder 

• Major depression 

• Bipolar disorder 

• Conduct disorder 

• Traumatic brain injury 

• Reading disabilities 

• Reactive attachment disorder 

• Schizophrenia 

Adequate and practical scientific review criteria 

The criteria for “gold standard” scientific research methods have increasingly 

and steadily grown stricter and more demanding. The result is that it is 

extraordinarily expensive and time consuming to conduct research that meets 

these strict standards, especially mental health and substance abuse treatment 

outcome research. 

While it is a worthy goal that treatment outcome studies attain this gold 

standard for all interventions in use, it simply is not practical. For example, 

many if not most parents of children with autism spectrum disorder recognize the 

importance of scientific research, but simply cannot afford to wait until all 

approaches are thoroughly studied with such rigorous methods. Instead they are 

willing to consider approaches that have preliminary evidence of efficacy as 

long as they are safe and have few adverse effects. 

In using this common sense, these parents are in fact supported by scientific 

evidence. It is a legitimate goal of scientific research to determine 

empirically the type of criteria that are most suitable for use in scientific 

review. The question of what type of research is needed to provide adequate 

empirical support for treatment can be answered using the scientific method. 

Some recent research of this type suggests that the increasing tendency to 

accept as adequate evidence only results from randomized controlled trials 

itself represents an opinion unsupported by the evidence base. 

Recent meta-analyzes comparing the results of observational studies versus 

randomized controlled trials to assess efficacy of medical treatment reveal that 

results from the two approaches to research are generally concordant . For 

example, analyzing data from 136 published reports of efficacy of 19 diverse 

medical treatments, Benson and Hartz concluded “In only two of the 19 analyses 

of treatment effects did the combined magnitude of the effect from the 

observational studies lie outside of the 95% confidence interval for the 

combined magnitude in the randomized controlled trials’”. (A comparison of 

observational studies and randomized, controlled trials. N. Engl. J. Med. 
342(25), 1878–1886 (2000) 

These findings suggest that in most instances, observational studies provide 

adequate data to evaluate treatment outcome. Since observational studies are 

much less costly and time consuming, scientific review criteria that are both 

adequate and practical may accept as valid evidence the outcome of less highly 

controlled observational studies. 

A clear violation of parity and equity 

Unquestionably, many if not most insurers employ more restrictive and limiting 

scientific review criteria in the evaluation of methods in mental and substance 

abuse treatment than are predominantly employed in medical and surgical 

treatment. The contrast between guidelines in cardiology and restrictions 

against EEG biofeedback is only one example. There are many others, such as 

limitations placed on psychological and neuropsychological assessment for many 

disorders. 

Empirical research suggests that these stricter standards are unnecessarily 

restrictive, since the findings of uncontrolled observational studies are 

generally concordant with findings form more controlled research. However, 

whatever standard is employed for assessing the scientific evidence, parity 

requires that the same standard is employed for mental health and substance 

abuse that is employed for most medical surgical treatments. But this is not in 

fact the case. 

Clearly, with regard to the example of EEG biofeedback, a well studied and safe 

treatment, the treatment limitations applicable to mental health or substance 

use disorder benefits are much more restrictive than the predominant treatment 

limitations applied to medical and surgical benefits covered by most plans. 

Parity requires that the same scientific review criteria be used for coverage of 

mental health and substance disorder treatment that predominate in coverage of 

medical and surgical services. However, for most insurers, EEG biofeedback is 

not a covered service, even though there is an empirical evidence-base for EEG 

biofeedback that is far stronger than that for many covered medical services. 

True parity, as envisioned in MHPAEA, will only be achieved when regulations 

require that insurers use the same scientific review criteria that are applied 

for the preponderance of medical and surgical treatments in providing and 

limiting access to mental health and substance abuse treatment. By this rule, 

EEG biofeedback should be covered. 

I strongly urge that you write and enforce regulations that require health 

insurers to use the same scientific review criteria for mental health and 

substance abuse services such as EEG biofeedback or neurofeedback that they use 

for most medical procedures. 

Thank you for your attention to this very important matter. I would be happy to 

provide documentation to support the claims made above about the level of 

evidence supporting EEG biofeedback. 

Sincerely, 

Laurence M. Hirshberg, Ph.D. 

Clinical Assistant Professor 

Department of Psychiatry and Human Behavior 

Alpert Medical School 

Brown University 

Director 
The NeuroDevelopment Center 

lhirshberg@neurodevelopmentcenter.com 

401 351 7779 

Attachments 

EBSA-2009-0010-DRAFT-0089.1: Comment on FR Doc # E9-9629