HOPE COUNSELING AND FAMILY THERAPY, INC.

www.hopecounselingtherapist.com

4100 E. Jurupa Street Suite 108 

Ontario, CA 91761 

Phone 909-561-5466 

Fax 909-463-1327 

5/26/2009 

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.”

I am a Licensed Marriage and Family Therapy and Psycho‐physiologist and own a mental health practice

servicing over two hundred adults and children monthly. I have been in full time practice for more than

9 years, working with children and adults with neurodevelopmental and neuropsychiatric problems. I

have presented on numerous topics in psychology at national and international conferences for Autism

and ADHD. I am a strong advocate of evidence based practice and pursue this comprehensively in the

clinic I own.

I summarize the relevant research on all forms of treatment available for the particular problem a client

presents 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.

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

metaanalyses

• 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:

y ‘‘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.

y ‘‘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.

y ‘‘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.

y ‘‘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:

y ADHD

y Autism spectrum disorders

y Substance abuse/addictions

y Generalized anxiety disorder

y Obsessive compulsive disorder

y PTSD

y Phobias

y Panic disorder

y Major depression

y Bipolar disorder

y Conduct disorder

y Traumatic brain injury

y Reading disabilities

y Reactive attachment disorder

y Schizophrenia

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‐analyses 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.

Cordially,

Jamie L. Juarez, Ph.D. Candidate, LMFT

President of Hope Counseling and Family Therapy, Inc.