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-0110 

TX 

Submitter Information 

Name: Fred Newman 

Address: 

Houston, TX, 77042 

Organization: Interface EAP, Inc. 

General Comment 

RE: CMS-4140-IFC 

Please see first attachment for comments. 

Second attachment is supporting documentation.

PUBLIC 

SUBMISSION 

As of: May 04, 2010 

Received: May 03, 2010 

Status: Draft 

Category: Health Care Professional or Association - HC001

Tracking No. 80ae5e9c 

Comments Due: May 03, 2010 

Submission Type: Web

Page 1 of 1

file://C:\Documents and Settings\baum.beth.EBSADOL\Local Settings\Temp\Temporary Di... 5/5/2010
RE: CMS-4140-IFC 

If mental health parity is to achieve the goal of improving mental health treatment for the 

majority of individuals experiencing mental health issues, then it must not only allow, but 

encourage evidence-based treatment to address the lack of quality care for those patients 

receiving mental health treatment in the general medical setting. As the Interim Final 

Rules point out, many individuals are seeking care for mental health issues in the general 

medical setting, with the vast majority not receiving adequate care (more than 83 percent 

did not receive minimally adequate care per the study cited in the Rules). Apparently, the 

agencies writing the Interim Final Rules recognized this issue and included language to 

allow for variations of the restrictions imposed on nonquantitative treatment limitations 

based on clinically appropriate standards of care. Just as evidence-based medicine will 

lead to improved health and outcomes for medical procedures, the same review and plan 

designs based on clinical guidelines should be applied to mental health treatment that is 

delivered in the general medical setting. 

The attached article, “Improving Treatment Outcomes through Drug Interventions,” that 

is published in the 2nd Quarter 2010, Journal of Employee Assistance, presents a proven 

program (with a case study) for dramatically improving treatment outcomes for mental 

health treatment delivered in the general medical setting through an evidence-based 

intervention. The intervention, called the Pharmacy Intervention Protocol (PIP), utilizes 

clinically appropriate standards of care for mental health treatment that are not usually 

applied within the general medical setting. To be successful, it utilizes a financial 

motivator to motivate behavior change, just as with evidence-based review for medical 

procedures that are deemed to not be clinically appropriate. Key to note, PIP only 

focuses on patients receiving mental health treatment from non-psychiatrists, which is 

well documented to result in suboptimal care for most. Furthermore, it only targets those 

psychotropic drugs that are primarily prescribed in the general medical setting, where 

appropriate clinical guidelines are most likely not being applied. 

What needs to be clarified in the Final Rules is the procedure for a clinically proven 

intervention like PIP to be allowed under the Final Rules based on the exception that 

recognized clinically appropriate standards of care may permit a difference. PIP is 

currently improving the care and outcomes for many patients while reducing their costs 

(and the costs to their employers) as a result of applying appropriate clinical guidelines. 

Those employers are now realizing better mental health services and outcomes for many 

of their members. This is leading to reduced costs in numerous areas and those 

employers do not want to take a step back whereby many of their employees and 

dependents will once again not receive optimum care. 

The result of the creation of PIP is a proactive evidence-based population management 

program for individuals seeking mental health care in the general medical setting. 

Furthermore, numerous studies have clearly documented the lack of quality mental health 

treatment in the general medical setting (as stated in the attached article). Certainly, any 
health plan would have a review process in place for a course of medical treatment that 

studies reported less than 13 percent of patients were receiving minimally adequate care 

from a type of provider. 

Beyond parity, the bigger picture is overall healthcare reform. As the administration has 

put forth, evidence-based treatment is one of the real solutions to many of our healthcare 

problems, and mental health must be included in that process. How much is the public 

sector spending towards lack of appropriate care for mental health? How much could be 

saved in the public sector by implementing evidence-based treatment for the millions of 

individuals dealing with mental health issues? The first step is continued use of this 

solution in the private sector, and then expansion into the public sector. 
by Fred Newman

Although many people assume

that the increasing prescription

of antidepressants and certain

other psychotropic drugs is a positive

trend and reflects the fact that more

people are seeking treatment for depression and other mental health conditions,

the reality is that most mental health

patients today are receiving sub-optimal

care. As the use of these drugs has increased over the past decade, the percentage of patients with behavioral

health issues being seen by mental

health professionals has decreased, 

not increased. 

The regulations that were developed to implement the Mental Health

Parity and Addiction Equity Act of 2008

outline this problem. The regulations

reference a study that found that only

12.7 percent of individuals received

minimally adequate mental health 

treatment in general medical settings.

Unfortunately, the regulations do not

address the root cause of this problem: 

a lack of access to appropriate mental

health care in the early stages of the 

condition.

Most psychiatrists have full patient

loads and do not have the capacity to

expand their practices to handle more

patients (many are already unable to

spend the time necessary to appropriately treat the patients they currently

have). Therefore, the majority of mental

health care will continue to be provided

within general medical settings for the

foreseeable future. This will lead to or

exacerbate the following quality issues:

• Lack of quality assessments of mental

health problems;

• Lack of ongoing screenings to evaluate the effectiveness of treatments;

• Lack of medication management;

• Lack of patient education about the

condition(s) being treated;

• Lack of psychotherapy for those dealing with mental health stressors; and

• Lack of feedback to patients regarding

improvement in their condition.

Individuals who face stressors they

cannot manage will typically receive 

prescriptions for antidepressants from a

non-psychiatrist. But without combining

short-term psychotherapy with their

drug therapy, only the symptoms of 

their condition will be treated.

Moreover, because most medical

doctors receive little or no training in

psychiatry, they often are not aware of

the withdrawal symptoms associated

with stopping the use of antidepressants

too quickly. What seems like a relapse 

of a depressive disorder may in fact be a

withdrawal symptom resulting from the

patient not properly tapering (reducing

the dosage of) the drug. This can lead 

to a recommendation of long-term drug

therapy when it may not be appropriate.

THE SOLUTION? EAPS

EAPs are in a unique position to address

this lack of quality treatment. Studies

report that if patients receive appropriate

treatment within the first six months of

the onset of a depressive disorder, they

have better than a 50 percent probability

of achieving remission. If they do not

receive appropriate treatment until one

year after the onset, the odds of remission drop to less than 20 percent.

Thus, it is imperative that individuals dealing with depression engage in

screenings and treatment modifications

as soon as possible based on their medical history and scoring of symptoms.

Influencing these individuals to take

such actions requires innovative programs that encourage participation in

results-oriented treatment solutions.

My company, Interface EAP, developed such a program in 2004. The program, known as Pharmacy Intervention

Protocol (PIP),* has proven to improve

outcomes and reduce costs. The key

components of PIP are as follows:

• A two-way secure data feed to the

pharmacy benefit manager (PBM) 

to exchange drug and compliance

information;

• Filtering of drug data from the PBM,

using proprietary software;

• Outreach to potential candidates

based on filtering of drug data;

• Financial incentives involving 

drug co-pays to encourage greater

Improving Treatment Outcomes

through Drug Interventions

Many people with mental health conditions receive care in general medical 

settings. EAPs can help improve their treatment and decrease symptoms.

www.eapassn.org 2nd Quarter 2010 • Journal of Employee Assistance • 9

Fred Newman is the

founder and chief executive officer of Interface

EAP and Coordinated

Health Solutions. He previously served as chief

financial officer of a public company that owned

and managed psychiatric

hospitals. He recently completed four-plus years

on the board of the Texas Association of Benefit

Administrators (TABA) and the Benefits

Committee for the Self Insurance Institute of

America (SIIA) and was recently elected to the

board for Mental Health America of Texas.

The majority of depressed

patients receiving care

within general medical 

settings will experience

worsening symptoms.
participation;

• Telephonic screenings to determine

candidates for participation;

• Daily electronic reporting of compliance/noncompliance to the PBM;

• Outreach to and partnering with 

prescribing physicians to improve

treatment outcomes;

• Results of ongoing standardized

screenings provided to patients and

physicians;

• Educational materials provided to

patients so they better understand the

conditions for which they are being

treated;

• Recommendations for medication

management and other treatment

modifications based on screening 

outcomes and treatment history;

• Coordination with the EAP for shortterm psychotherapy when appropriate;

• Outcome reporting on quality improvement and cost savings; and

• Compliance with the Health Insurance Portability and Accountability

Act (HIPAA) and the Americans with

Disability Act (ADA) per established

legal opinions.

PIP CASE STUDY

On June 15, 2009, Interface EAP and

Aetna completed an initial outcome

study reviewing medical claims costs

across two years of data for workers covered under a self-funded health plan

provided by an Arizona hospital system.

The purpose was to evaluate overall

medical claims costs and other data

resulting from PIP.

The study looked at plan members

who filled prescriptions for predetermined target drugs, which were identified from the plan’s drug data. Every two

weeks, PIP received drug data from the

PBM (Express Scripts) through the plan

administrator (Schaller/Anderson–

Aetna). Based on defined criteria, the

drug data were filtered by Interface 

EAP to identify plan members as 

potential PIP candidates.

A financial motivator was used by

the health plan to encourage candidates

to complete a telephonic screening. If 

a plan member did not complete the

screening, his/her co-pay for this group

of drugs was doubled; if a plan member

completed the screening but chose not

to participate in PIP, his/her co-pay was

doubled. Those who completed the

screening and participated in PIP for up

to 18 months received prescriptions at

the normal co-pay level. If a member did

not complete the program, his/her copay was doubled.

Using this process, PIP identified a

compliant group and a noncompliant

group by unique member ID. The compliant group was defined as plan members who had filled a target prescription,

completed the screening, participated in

the protocol for the required time

period, and were covered by the health

plan for both 12 months prior to the

intervention date and 12 months after

the intervention date.

The noncompliant group was

defined as plan members who had filled

a target prescription but failed to complete the screening, declined participation after completing the screening, or

10 • Journal of Employee Assistance • 2nd Quarter 2010 www.eapassn.org

“A significant proportion of individuals with behavioral health problems

are treated exclusively in the general

medical setting, which has become

the de-facto mental healthcare system...significant quality problems

have been found with general medical providers’ screening, treatment,

and monitoring practices.”

“An Employer’s Guide To Behavioral

Health Services,” National Business

Group on Health, 2005

“Although access to psychotropic

medications is available due to nonpsychiatrists’ prescriptions, concerns

remain that patients still receive treatment in accordance with evidencebased guidelines, psychotherapy,

adequate medication monitoring, and

appropriate intensity of treatment.”

An article in Open Minds on

September 24, 2009, reporting on a

study in which researchers reviewed

472,173 prescriptions filled between 

August 2006 and July 2007 from

the IMS National Prescription Audit

Plus database. The researchers

reported that 79 percent of prescriptions for antidepressants were

written by non-psychiatrists and 87

percent of prescriptions for anxiolytics were written by non-psychiatrists.

“The effectiveness of a dozen popular antidepressants has been exaggerated by selective publication of

favorable results.”

“... doctors unaware of the unpublished data are making inappropriate

prescribing decisions that are not in

the best interest of their patients.”

“There is a view that these drugs are

effective all the time ... I would say

they only work 40 percent to 50 percent of the time based on reviews of

the research at the FDA.”

Excerpts from a January 17, 2008,

Wall Street Journal article regarding

a review published the same week

in The New England Journal of

Medicine.

“More Americans are being prescribed multiple psychiatric medications for use at the same time, but

most people diagnosed with recent

depression don’t get adequate treatment, according to two independent

studies published Monday.”

“Studies: Mental Ills Are Often

Overtreated Or Undertreated,” Wall

Street Journal, January 5, 2010

“There is little evidence to suggest

that (antidepressants) produce specific pharmacological benefit for the

majority of patients with less severe

acute depression,” researchers wrote.

Excerpt from a January 6, 2010,

Wall Street Journal article regarding

a study published the same week in

The New England Journal of

Medicine.

Mental Health Care: What the Media are Saying
dropped from the protocol prior to completion. Like the members of the compliant group, they must have been covered

by the health plan for both 12 months

prior to the intervention date and 12

months after the intervention date.

The intervention date was defined

as the date that a compliant group member began participating in PIP or the

date a noncompliant group member was

reported noncompliant to the PBM. For

purposes of the study, the health plan

administrator reported medical claims

data by member ID for the year prior to

the intervention date and the year after. 

For the 24-month period, the following results were reported:

• Compliant Group (142 members): 

A decrease in average annual claims

costs of $5,674 per plan member, or

a 29.4 percent overall decrease in

claims costs for the year after the

intervention date versus the year

before the intervention date.

• Noncompliant Group (272 members): An increase in average annual

claims costs of $16 per member, or a

0.1 percent overall increase in claims

costs for the year after the intervention date versus the year before the

intervention date.

In addition, the following outcomes

were reported:

• Nearly two-thirds (63 percent) of

members who had completed multiple standardized screenings scored a

reduction in their symptoms within

the first 15 months of the program.

• EAP utilization increased to an annual

average of 21 percent in the first year

of PIP. In the years before PIP was

introduced, the annual average EAP

utilization rate was 5 percent. For the

second year of PIP, annual EAP utilization was 14.8 percent, a significant increase in utilization over the

years prior to PIP.

• Drug spending for the target drugs

declined by 30 percent within 15

months of the start of PIP as calculated on a per employee, per month

(pepm) basis. Documented reduced

drug spending exceeded the pepm

cost of PIP by 59 percent.

BECOMING THE GATEWAY

It is a clinical fact that depression, if 

not properly treated, will worsen and

become more resistant to treatment.

Therefore, the majority of depressed

patients receiving care within general

medical settings will experience worsening symptoms and, once exposed to

direct consumer marketing by psychiatric facilities, will encounter more

restrictive and costly levels of care.

Expanded mental health benefits under

the new health insurance parity law 

will only magnify the cost impact to

employers.

EAPs can become the gateway to

early treatment and help reduce the

number of chronic patients. Through a

program like PIP, EAPs can use their

assessment and counseling resources to

bridge the gap in quality care.

Although the parity law regulations

generally prohibit imposing any nonquantitative treatment limits on mental

health or substance use disorders that

are not also applied to medical/surgical

benefits in the same classification, they

do allow for variations to the extent that

recognized clinically appropriate standards of care may permit a difference.

Therefore, the regulations should permit

a difference in drug plan design for PIP,

since it applies clinically appropriate

standards of care not utilized in the general medical setting to achieve significant

outcome improvements. For example,

the study presented in the regulations

reported that only 12.7 percent of individuals treated in general medical settings received minimally adequate mental health care, while 63 percent of PIP

members seeking mental health treatment in general medical settings reduced

their symptoms.

It is only logical for EAPs to evolve

into population management roles for

mental health, given the current lack of

quality treatment for so many. The total

cost of not properly treating mental

health issues extends to increased medical claims, increased disability claims,

and reduced productivity (as the regulations also report). ■

* Patent pending

www.eapassn.org 2nd Quarter 2010 • Journal of Employee Assistance • 11

*1/5 + )+3;+,3/ "4736=// (/9:9 &692:2</

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