August 26, 2010 

 

 Mr. Jay Angoff 

 Office of Consumer Information and Insurance Oversight 

Department of Health & Human Services 

Attention: OCIIO-9994-IFC 

P.O. Box 8016 

Baltimore, MD 21244-1850 

Electronic Submission to regulations.gov: 

Document ID HHS-OS-2010-0014-0001 

Re: Preexisting Condition Exclusions, Lifetime and Annual Limits, 

Rescissions, and Patient Protections 

Dear Mr. Angoff: 

The Bazelon Center for Mental Health Law—a national legal-advocacy 

organization representing children and adults with serious mental 

illnesses—is pleased to submit the following comments on the Interim Final 

Rules for Preexisting Condition Exclusions, Lifetime and Annual Limits, 

Rescissions, and Patient Protections under the Affordable Care Act. We 

appreciate the opportunity to provide feedback on these important 

regulations. 

General Comments

We strongly support the Departments’ efforts to provide robust regulations 

that ensure the protection of health insurance consumers, and continued 

access to high quality, affordable care. We applaud the efforts of the 

Departments to honor the intention of the Affordable Care Act to end 

discriminatory practices that too often affect consumers, including those 

with serious mental illnesses. 

Additional Comments

The Bazelon Center would like to submit additional comments on the 

following aspects of the interim final regulations: 

Civil Rights and Human Dignity 

BOARD OF TRUSTEES 

Nikki Heidepriem, Chair 

Fabiani & Company, Washington DC 

Anita L. Allen 

University of Pennsylvania Law School 

David B. Apatoff 

Arnold & Porter, Washington DC 

Eileen A. Bazelon 

Department of Psychiatry 

Medical College of Pennsylvania 

Rhonda Robinson-Beale 

OptumHealth Behavioral Solutions

Robert A. Burt 

Yale Law School 

Jacqueline Dryfoos 

New York NY

Kenneth R. Feinberg 

Feinberg Rozen, LLP, Washington DC 

Howard H. Goldman 

Department of Psychiatry 

University of Maryland School of Medicine 

Emily Hoffman 

Cleveland, Ohio

Jacki McKinney 

National Association of People of Color 

Consumer/Survivor Network 

Martha L. Minow 

Harvard Law School 

Stephen J. Morse 

University of Pennsylvania Law School 

Joseph G. Perpich 

JG Perpich LLC, Bethesda MD 

Paul Recer 

Science and medi al journalis c t 

Washington DC

Harvey Rosenthal 

New York Association 

of Psychiatric Rehabilitation Services 

Elyn R. Saks 

University of Southern California 

Gould School of Law 

W. Allen Schaffer, MD 

Bangor, ME

Cynthia M. Stinger 

Washington Group International 

Martin Tolchin 

Journalist and author, Washington DC 

Sally Zinman 

Mental Health Consultant 

Berkeley, CA 

HONORARY TRUSTEE 

Miriam Bazelon Knox 

Washington DC 

TRUSTEES EMERITI 

Mary Jane England 

Regis College 

H. Rutherford Turnbull, III 

Beach Center for Families and 

Disability, University of Kansas 

PRESIDENT & DIRECTOR 

Robert Bernstein, PhD 

Affiliations listed for informational purposes only

I. Preexisting Conditions 

II. Lifetime and Annual Limits 

III. Rescissions 

IV. Patient Protections 

1101 Fifteenth Street NW, Suite 1212, Washington DC 20005 u 202-467-5730 (voice) 202-223-0409 (fax) u www.bazelon.org 
V. Monitoring and Oversight 

Preexisting Conditions

We applaud and strongly support the interim final rules regarding preexisting condition 

exclusions. This provision is particularly important for people with serious mental illnesses, who 

often fail to qualify for coverage –particularly for individual or small-group insurance– because their 

disorder constitutes a preexisting condition, or who face lengthy waiting periods or exclusions on 

coverage for services provided for that preexisting illness. We urge the Departments to strengthen 

these regulations by broadening the definition of preexisting condition exclusions to cover additional 

forms of discrimination. These include: 

 Waiting periods in excess of 90 days should be included within the definition of 

preexisting condition exclusions. 

 Coverage exclusions of or arbitrary restrictions on benefits, especially those benefits that 

are included among the “essential health benefits” package required for some plans under 

the Affordable Care Act, should be considered as preexisting condition exclusions. We 

are particularly concerned about benefits in the area of rehabilitation and habilitation 

services and devices. 

Lifetime and Annual Limits 

We commend the Departments for including strong protections in regards to lifetime and 

unreasonable annual limits on “essential health benefits” as defined in the Affordable Care Act. 

Lifetime and annual limits often serve as a barrier to care, or lead to treatment delays and 

interruptions for beneficiaries and negatively affect continuity of care. We also believe that the 

interim final regulations could be enhanced in a number of ways. 

First, we encourage the swift promulgation of regulations that define the exact scope of services 

to be included among the essential health benefits package in order to ensure that consumers 

benefit fully from the protection from lifetime and unreasonable annual limits as intended by the 

Affordable Care Act. We welcome the provision that requires plans to make a “good faith 

effort” to comply with a reasonable interpretation of the term essential health benefits until such 

regulations are released. However, this requirement does afford plans much discretion in 

determining the scope of benefits to which the restriction on limits apply in order to demonstrate 

such an effort, and may lead to much variability in the range of benefits subject to the prohibition 

on lifetime and unreasonable annual limits among insurers and plans. We urge the Departments 

to issue additional guidance on “good faith efforts” that establishes a clear, objective definition 

of and offers examples that illustrate adherence to such efforts. Such clarification should also be 

crafted to ensure that plans include the full range of services typically needed by patients with 

chronic conditions in order to remain in compliance with the good faith requirement. 

We are also concerned that although the law bans lifetime and unreasonable annual dollar limits, 

plans are permitted to apply non-monetary limits, such as restrictions on the number of physician 

or mental health visits, or length of stay in the hospital. This is particularly problematic for 

individuals with chronic conditions who often require more frequent and intensive services. We 

urge the Departments to monitor and disseminate information to consumers on trends in the 
application of non-dollar limits. It may also be helpful to require that plans ensure that 

beneficiaries are made aware that non-monetary limits may be employed and clarify whether 

such limits apply to their plan. Similarly, we believe that consumers must be provided with 

adequate information about their benefits in order to make informed choices and benefit fully 

from their insurance coverage. Plans should, therefore, be compelled to provide clear and 

specific details to consumers regarding annual limits, such as how frequently a particular service 

can be utilized before an annual limit is reached. 

Another necessary clarification concerns the application of the prohibition on lifetime and 

unreasonable annual limits to self insured plans. Such plans need not adhere to the essential 

benefits package standards required of other plans, and, therefore, clarification is needed to 

illustrate if and how the lifetime and annual limit prohibition pertains to self-insured plans. 

Finally, we recognize and appreciate the need to include the authority of the Secretary of Health 

and Human Services to waive restrictions on annual limits if compliance would result in a 

significant decrease in access to benefits or a significant increase in premiums. We do, however, 

believe that additional consumer protections must be included to ensure that such waivers do not 

disproportionately and negatively impact specific population groups, such as those with 

disabilities or poor health status. 

Rescissions 

We applaud the inclusion of strong regulations that prohibit insurers from rescinding coverage 

except in cases of fraud or intentional misrepresentation of a material fact. We are particularly 

pleased that the regulations set a federal floor for rescissions and clarify that additional federal or 

state laws may apply in connection with the regulations if they are offer more protection for 

insurance consumers. We also urge the Departments to consider strengthening the interim final 

rules in the following ways: 

 In the case of suspected fraud or intentional misrepresentation of a material fact, we believe that 

consumers under review should be allowed adequate time to offer relevant evidence to their 

insurer, as well as be given the opportunity for an independent, third-party review of any 

rescissions. 

 We also urge the Departments to consider providing plans with a standardized model 

insurance application and informational or health history questionnaire that clearly 

instructs consumers on how to fairly and accurately complete the application. To further 

strengthen such model documents, we recommend that the standard in §2715 of the ACA 

that mandates the provision of plan documentation and materials presented in a 

“culturally and linguistically appropriate manner and utilizes terminology understandable 

by the average plan enrollee,” be similarly applied to the suggested model application and 

instructions. 

Patient Protections 

We applaud the Departments for addressing key patient protections which will ensure consumer 

choice and access to care. We are particularly pleased with the provision that allows patients to 
select any primary provider that accepts their insurance. We also commend the protections that 

will ensure that parents can choose any available participating pediatrician to be their children’s 

primary care provider, and prohibit insurers from requiring a referral or prior authorization for 

obstetrical or gynecological or out of network emergency care. 

We encourage the Departments to strengthen these protections in a number of ways. First, we 

believe that primary care providers eligible to be designated by beneficiaries should be defined in 

functional terms; such a definition should not be based solely on the type of practitioner that is 

providing the care. We urge the adoption of a definition of primary care that could conceivably 

include providers of specialty care, or primary care providers who are practicing under the 

umbrella of specialty providers or practices, such as the following definition proposed by the 

Institute of Medicine (IOM): 

Primary care is the provision of integrated, accessible health care services by clinicians 

who are accountable for addressing a large majority of personal health care needs, 

developing a sustained partnership with patients, and practicing in the context of family 

and community. i

This is particularly important for people with serious mental illnesses. For m any of these 

individuals, the only routine health they receive is provided by their mental health providers in

community behavioral health settings. It will be important to clarify whether enrollees will be 

able to select a participating community behavioral health center (CBHC) as their primary care 

provider if primary care services or providers are integrated under the umbrella of the CBHC. 

Additionally, we believe that it is important to strengthen the protections relating to the provision 

of emergency care without prior authorization. We support the regulations that protect patients 

from undue cost-sharing and administrative burdens without needing prior authorization should 

they receive out-of-network emergency care, but suggest that corresponding guidance be issued 

to protect beneficiaries from similar unreasonable burdens that may result from the receipt of innetwork emergency. 

Monitoring and Oversight 

We also encourage the Departments to promulgate further guidance regarding the monitoring of 

health plans for violations of the prohibitions and restrictions set forth in these Interim Final 

Regulations. There is a great need for a strong, well-defined mechanism for enforcement and 

oversight of plans, and suggest that additional guidance be included to describe such a 

mechanism. The regulations should also clarify who may submit challenges to a plan’s 

adherence to these regulations (whether it be consumers, providers, state agencies, or advocacy 

organizations), as well as what entity will be responsible for reviewing such claims. 

We are particularly concerned about the monitoring of self-insured ERISA plans. It may prove 

especially difficult for the Department of Labor to adequately regulate and enforce applicable 

provisions in the law and regulations in the large self-insurance market. The system for reporting 

concerns and the process by which concerns will be reviewed must be further delineated to 

ensure transparency, adequate enforcement, and plan accountability. 
We thank you again for the opportunity to comment on these regulations, and appreciate your 

consideration of our proposed recommendation. We welcome the opportunity to discuss any of 

these thoughts in greater detail. Please contact Allison Wishon Siegwarth at 202-467-5730 x 113 

or allisonw@bazelon.org for additional information or further clarification. 

 

Most sincerely, 

Chris Koyanagi 

Policy Director 

 

i

 Institute of Medicine, Committee on the Future of Primary Care, Primary Care: America’s Health in a New Era 

(Washington: National Academy Press, 1996), p. 31.