Docket: CMS-2009-0040 

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

Equity Act of 2008 

Comment On: CMS-2009-0040-0001 

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

Equity Act of 2008 

Document: CMS-2009-0040-DRAFT-0038 

DC 

Submitter Information 

Name: Suzanne McDonald 

Address: 

Washington, DC, 20001 

Organization: Takeda Pharmaceuticals North America, Inc. 

General Comment 

Takeda commends CMS, the Internal Revenue Service (IRS), and the Employee 

Benefits Security Administration (hereafter referred to as “agencies”) for seeking 

additional information to aid in the development of regulations implementing 

MHPAEA. Takeda submits these comments in response to issue “Number 2” in 

the agencies’ joint request for information, which asks the following: “What terms 

or provisions require additional clarification to facilitate compliance? What specific 

clarifications would be helpful?” 

In response to these requests, Takeda believes that it is important to highlight 

three issues that warrant clarification and that must be addressed to affect the 

intent of the MHPAEA: 

(1) The definition of the term “mental health benefits;” 

(2) The law’s parity standards for “financial requirements”, as applied to 

prescription medications that treat mental health conditions, including the 

antidepressant class; and 

(3) Treatment limitation provisions that are directed to quantity limits on mental 

health drugs, including the antidepressant class.

PUBLIC SUBMISSION 

As of: May 29, 2009 

Received: May 28, 2009 

Status: Draft 

Category: Drug Industry - PI010

Tracking No. 809bc865 

Comments Due: May 28, 2009

Submission Type: Web
Attachments 

CMS-2009-0040-DRAFT-0038.1: DC
TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. 

750 Ninth Street, NW Suite 575 Washington, DC 20001-4584

May 28, 2009 

Acting Administrator Charlene Frizzera 

Centers for Medicare and Medicaid Services 

Department of Health and Human Services 

Attention: CMS-4140-NC 

P.O. Box 8017 

Baltimore, MD 21244-8010 

Re: Comments on Request for Information Regarding the Paul Wellstone and Pete 

Domenici Mental Health Parity and Addiction Equity Act of 2008 [CMS-4140-NC; 

Response to Issue #2] 

Dear Acting Administrator Frizzera: 

Takeda Pharmaceuticals North America, Inc. (Takeda) appreciates the 

opportunity to submit comments to the Centers for Medicare and Medicaid Services 

(CMS) in response to its request for information regarding issues under the Paul 

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

(MHPAEA).1

 Takeda is one of the nation’s leading pharmaceutical companies and is 

committed to striving toward better health for individuals and progress in medicine by 

developing innovative pharmaceutical products. We currently market oral diabetes, 

insomnia, gastroenterology, and hyperuricemia treatments. We seek to bring new 

pharmaceutical products to patients through a pipeline that includes compounds in 

development for diabetes, psychiatric conditions such as depression, cardiovascular 

disease, oncology, gastroenterology, neurology, rheumatology and other conditions. 

Takeda commends CMS, the Internal Revenue Service (IRS), and the Employee 

Benefits Security Administration (hereafter referred to as “agencies”) for seeking 

additional information to aid in the development of regulations implementing MHPAEA. 

Takeda submits these comments in response to issue “Number 2” in the agencies’ joint 

request for information, which asks the following: “What terms or provisions require 

additional clarification to facilitate compliance? What specific clarifications would be 

helpful?” 2

 

In response to these requests, Takeda believes that it is important to highlight 

three issues that warrant clarification and that must be addressed to affect the intent of the 

MHPAEA: 

(1) The definition of the term “mental health benefits;” 

 

1

 74 Fed. Reg. 19155 (April 28, 2009). 

2

 74 Fed. Reg. 19155, 19157.
Frizzera, Acting Administrator, CMS 

5/28/2009 

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TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. 

750 Ninth Street, NW Suite 575 Washington, DC 20001-4584 

(2) The law’s parity standards for “financial requirements”, as applied to 

prescription medications that treat mental health conditions, including the 

antidepressant class; and 

(3) Treatment limitation provisions that are directed to quantity limits on mental 

health drugs, including the antidepressant class. 

1. Agencies Are Urged to Clarify the Definition of “Mental Health Benefits” in 

a Manner Which is Consistent With the Purposes of the Act 

Prescription medications have become some of the most efficacious and cost 

effective treatments for many illnesses and conditions, including mental health conditions 

such as depression or schizophrenia. Particularly due to their central role in treating 

mental health conditions, it is important that the regulations implementing MHPAEA 

spell out clearly how the law’s parity requirements apply to prescription medications 

covered by health plans. This will require that the regulations clearly define “mental 

health benefits.” In the absence of addressing this issue, the reality is that the Act may 

not achieve its intended goal of ensuring true parity for mental health benefits. This issue 

quite clearly implicates the fundamental purpose of the MHPAEA. 

As specified by the MHPAEA, if a health plan provides mental health benefits, key 

parity requirements include: 

1) The financial requirements for mental health or substance use disorder benefits 

may not be “more restrictive than the predominant financial requirements applied 

to substantially all medical and surgical benefits covered under the plan.” 3

 

Financial requirements are defined as including “deductibles, copayments, 

coinsurance and out-of-pocket expenses. . . ;” 4 and 

2) “The treatment limitations applicable to such mental health or substance use 

disorder benefits can be no more restrictive than the predominant treatment 

limitations applied to substantially all medical and surgical benefits.” 5

 Treatment 

limitation is defined to include “the frequency of treatment, number of visits, days 

of coverage, or other similar limits on the scope or duration of treatment.” 6

The law defines “mental health benefits,” as “benefits with respect to services for 

mental health conditions, as defined under the terms of the plan and in accordance with 

applicable Federal and State law.” (Emphasis added).

7

 Technically, this might mean that 

“mental health benefits” are those labeled as such by a health plan. However, this 

reading would not make sense because it would permit a plan to label what would 

 

3

 29 U.S.C. §1185a(a)(3)(A)(i); 42 U.S.C. §300gg-5(a)(3)(A)(i); 26 U.S.C. §9812(a)(3)(A)(i) 

4

Id at 29 U.S.C. §1185a (a)(3)(B)(i); 42 U.S.C. §300gg-5(a)(3)(B)(i); 26 U.S.C. §9812(a)(3)(B)(i) 

5

Id at 29 U.S.C. §1185a (a)(3)(A)(ii); 42 U.S.C. §300gg-5(a)(3)(A)(ii); 26 U.S.C. §9812 (a)(3)(A)(ii). 

6

Id at 29 U.S.C. §1185a (a)(3)(B)(iii); 42 U.S.C. §300gg-5(a)(3)(B)(iii); 26 U.S.C. §9812 (a)(3)(B)(iii).

7

Id at 29 U.S.C. §1185a(e)(4); 42 U.S.C. §300gg-5(e)(4); 26 U.S.C. §9812 (e)(4). 
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TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. 

750 Ninth Street, NW Suite 575 Washington, DC 20001-4584 

ordinarily be considered a mental health service as something other than a mental health 

service or benefit and thereby avoid triggering the law’s parity requirements. Likewise, a 

plan could inadvertently avoid the parity requirements by covering drugs that are used to 

treat depression or schizophrenia as part of its “pharmacy” benefit (as plans typically do) 

instead of its “mental health benefit”. This scenario is realistic because typically a 

pharmacy benefit does not differentiate between “mental health” and “medical” drugs. 

We are hopeful that CMS and the other agencies will jointly confirm that parity 

applies to drugs used to treat mental health conditions even if the health benefits are not 

labeled by the health plan as mental health benefits. These medications can be lifesaving, 

and they improve the quality of life for millions. In an effort to balance the need for 

greater clarity to properly effectuate the statute and preserve health plans’ decision 

making authority in formulary development in order to best manage the costs and 

utilization of prescription drugs, Takeda respectfully proposes the following regulatory 

definition of “mental health benefits” for the agencies’ consideration: 

The term ‘mental health benefits’ means benefits for items and services (including 

prescription drugs) that are: (1) covered by the plan, as determined under the 

terms of the plan and any applicable Federal or State law; and (2) used to treat 

mental health conditions, meaning conditions listed in the current version of the 

Diagnostic and Statistical Manual of Mental Disorders (DSM). 

We believe this definition makes clear that health plans retain the right to 

determine which, if any, mental health conditions they will cover, while clarifying that 

coverage of certain conditions, identified by reference to a well-recognized list of mental 

health conditions, is subject to the parity requirements of the Act (regardless of whether a 

plan calls the coverage a mental health benefit). At the very least, a definition must 

recognize that medication is the front line treatment to address mental illness, including 

depression, and that “items and services” should similarly extend to mental health drugs 

in the broader definition of “mental health benefits.” 

2. Agencies Should Provide Guidance on the Application and Calculation of 

Financial Parity 

The MHPAEA provides greater access to mental health treatments and services

by eliminating discriminatory cost sharing practices for many Americans already 

struggling with high health care costs. With passage of the bill, Congress has sent the 

message that those who suffer from mental illness are on equal footing with those who 

suffer from other health conditions and that it is necessary to protect their benefits.

To ensure that these mental health treatments are truly attainable, we urge the 

agencies to provide additional clarification and guidance on the application of the 

financial parity requirement to prescription drugs, as it remains unclear how the 
Frizzera, Acting Administrator, CMS 

5/28/2009 

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TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. 

750 Ninth Street, NW Suite 575 Washington, DC 20001-4584 

predominant” financial requirement is determined and/or calculated.8 For example, it is 

not clear whether, in the case of medications, the “predominant” co-pay would be based 

on the single most common co-pay for “medical or “surgical” benefits (and whether 

“medical” or “surgical” benefits would include prescription drugs that are used for 

purposes other than mental health) even if that meant mental health drugs ended up with 

a different co-pay than other drugs, or whether a plan would pick the most common copay that applied to medications used for purposes other than mental health. One 

approach that would meet the statutory goals and be administratively simple to effectuate 

might be to specify that the most common medical and surgical co-pay would be that for 

a visit to a physician’s office, or (alternatively) the most common co-pay for prescription 

drugs for purposes other than mental health. 

3. Agencies Should Provide Guidance on the Application of the Statute’s 

Treatment Limitation Provisions to Quantity Limits on Mental Health Drugs 

MHPAEA requires plans or coverage to ensure that the treatment limitations 

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.9 “Treatment limitations” include “limits on the 

frequency of treatment, number of visits, days of coverage, or other similar limits on the 

scope or duration of treatment.” 10 Thus, it would be helpful if the agencies make clear in 

the regulations that the treatment limitations subject to the parity requirements include 

quantity limitations on prescription drugs used for mental health conditions. 

Our research shows that quantity limits are a significant concern because 55 

percent of all plans in 2008 covering brand name anti-depressants used quantity limits. 

These limitations can have devastating consequences for people already stabilized on 

mental health medications. Further, studies have shown that current utilization 

management strategies may significantly increase costs of other services (e.g., emergency 

room visits, hospitalizations, costs associated with suicidal or violent ideation or 

behavior, and homelessness) for this population, and that limits on the number or dosing 

of medications may be problematic for this population.

11 Additionally, patients with 

more severe depressive or anxiety symptoms are significantly more likely to experience 

problems accessing clinically indicated medications or are subject to more adverse events 

when utilization management tools are employed. Our data show that compared to 2008, 

 

8

 The regulation only notes that a financial or treatment limit is considered “predominant” if it is “the most 

common or frequent” type of limit or treatment, providing the agencies with clear authority to issue a

regulation reflective of our recommendation. 74 Fed. Reg. 19156. 

9

 29 U.S.C. §1185a (a)(3)(A)(ii); 42 U.S.C. §300gg-5(a)(3)(A)(ii); 26 U.S.C. §9812 (a)(3)(A)(ii). 

10 Id at 29 U.S.C. §1185a (a)(3)(B)(iii); 42 U.S.C. §300gg-5(a)(3)(B)(iii); 26 U.S.C. §9812 (a)(3)(B)(iii) 

11 American Psychological Association, “Facts about Suicide in Older Adults,” available at 

http://www.apa.org/ppo/issues/oldersuicidefact.html. See also Joyce C. West, Joyce, Wilk, Joshua, et al.: 

Medication Access and Continuity: The Experiences of Dual-Eligible Psychiatric Patients During the First 

4 Months of the Medicare Prescription Drug Benefit. Am J Psychiatry 2007; 164:789–796. 
Frizzera, Acting Administrator, CMS 

5/28/2009 

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TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. 

750 Ninth Street, NW Suite 575 Washington, DC 20001-4584 

in 2009, an even greater percentage of plans will apply quantity limits to select drugs. To 

that end, we urge the agencies to ensure that the same parity requirements for quantity 

limits apply equally to prescription drugs, as it would for medical/surgical services. 

Summary 

Takeda appreciates the opportunity to submit comments in response to provisions 

that require additional clarification to facilitate compliance. In particular, we believe that 

greater clarification is needed on the definition of “mental health benefits.” Without an 

adequate definition, patients could potentially experience limits on the quantity, 

frequency or duration of treatment. Takeda also urges the agencies’ for additional 

clarification and guidance on the application of the financial parity requirement to 

prescription drugs, as it remains unclear how the “predominant” financial requirement is 

determined and/or calculated. Without added clarification, it could result in potentially 

higher co-payments for mental health treatments compared to medical/surgical benefits. 

Finally, we request guidance on the application of the statute’s treatment limitation 

provisions to quantity limits on mental health drugs in order to ensure that these 

utilization tools are not inadvertently used to discriminate against patients with mental 

illness, including depression. 

* * * 

Thank you for your consideration. If you have any questions or require further 

information, please contact me at (224) 554-5647. 

Sincerely, 

Suzanne McDonald 

VP Government and External Affairs