National

PKU

Alliance

P.0. Box 501 * Tomahawk, WI 54487-0501 » Phone: 715-437-0477 ® Fax: 715-453-7670 »* www.npkua.org x

August 17, 2010

Office of Consumer Information and Insurance Oversight

Department of Health and Human Services

Attention: OCIIO-9994-IFC

Mailstop C4-26-05

7500 Security Boulevard

Baltimore,-MD°21244=1850° ~— Serres ere nms aaa

File Code OCIIO-9994-IFC
Dear Sir or Madam:

The National PKU Alliance appreciates this opportunity to comment on the Interim Final Rule
with Request for Comments entitled “Patient Protection and Affordable Care Act; Requirements
for Group Health Plans and Health Insurance Issuers Under the Patient Protection and
Affordable Care Act Relating to Preexisting Condition Exclusions, Lifetime and-Annual Limits,
Rescissions; and Patiéent-Protections” (Final Rule and Proposed? Rule). H Wa Phd!

The National PKU ‘Alliance i is a 4501 (¢)3- non-profit organization. We have a ‘dusal mission:
improve the daily lives of those individuals and families affected by PKU and accelerate the
timeline for a cure by investing in targeted research.

Our comments on the Interim Final Rule with Comments are focused on annual limits and the
definition of “essential health benefits’.

Annual limits

Recommendation: The Secretary of HHS should use its authority | to establish higher
minimum annual limits for persons with rare genetic disorders.

We are pleased that the Agency has established minimum individual annual benefits, and that

- the dollar amounts increase over the timeframe of 2010-2014. Persons with rare genetic

disorders, such as PKU, may have exceptional medical needs and incur costs that exceed the
limits you outline in this Interim Firial Rule. When these persons exceed their annual limit, they
often.cannot afford life sustaining medical care. Persons with rare diseases then find ‘
themselves i in untenable situations- in that their pre-existing condition makes it impossible to
switch insurers ‘or go without care in order to qualify for the temporary high risk pool. Therefore,
we ask that you utilize your discretion to establish higher-annual limits for persons: with rare:
genetic disorders. ”

research | education | support | advocacy



Essential Health Benefits ss

Recommendation: The Secretary of HHS should establish a transparent process ands +
establish a meaningful definition of “essential health benefits.”

Lifetime and annual limits apply to ‘essential health benefits” only. The Interim Final Rule states,
“These interim final regulations define “essential health benefits” by cross-reference to section
1302(b) of the Affordable Care Act and applicable regulations. Regulations under section
1302(b) have not yet been issued.” Section 1302(b) permits the Secretary to establish “at least”
the categories specified in the Act. We urge the Secretary to establish a transparent process to
define “essential health benefits” and promptly establish its definition of “essential health
benefits”.

-The standard of.care,-and often-the.only-available-treatment for persons-with-metabolic
disorders include services and items that would only be covered under an expanded definition
of “essential health benefits.” We welcome the opportunity to engage in dialog with HHS to
ensure that the medical foods that are essential to treat PKU and similar inborn errors are
metabolism are considered “essential health benefits” subject to the array of protections under
the Accountable Care Act.

In summary, the Accountable Care Act provides the foundation for health care access for all
Americans. We ask the Secretary to be mindful and use its discretion to ensure the needs of
persons with rare genetic disorders are protected in its implementation of this important law.

Please do not hesitate to contact us with any questions regarding these comments. .

Sincerely, .

[highend rm

Christine S. Brown
Executive Director

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