% Deb Lee Gould, MEd, Director
~ —=—— MCAD Parent and Grief Consultant
Grief Support for Bereaved Parents and
Families

PO Box 54

m Hj rt Okemos, MI 48805-0054
Fa ily Suppo Office/Cell: 517.381.1940
1 F, idation Group Fax: 866.290.5206

Family Support trowp Email: deb@fodsupport.org
! fodsuy Website: www.fodsupport.org
* rfodsupport.org Federal Tax ID # 83-0471342

Board of Directors August 16, 2010
Deb Lee Gould, MEd
| FOD Parent, Director, and President

: Daniel R Gould, PhD

| FOD Parent and Treasurer Office of Consumer Information and Insurance Oversight
' Mary Lingle Department of Health and Human Services
FOD Parent, Webmaster, and Secretary Attention: OCIO-9994-IFC
~~——Honorary Diréctors— ~~~ ~ Mailstop C4-26-05 " —~ * ae ~
Kevin Gould, MCAD Adult 7500 Security Boulevard
Brian Gould, MCAD Sibling Baltimore, MD 21244-1850
Board of Medical Advisors
Charles R Roe, MD Re: File Code OCIIO-9994-IFC
Consultant :
Dallas, TX
Mark Korson, MD Dear Sir or Madam:
Tufts-New England Medical Center
Boston, MA

we . A hi
Jerry Vockley, MD, PhD The FOD (Fatty Oxidation Disorders) Family Support Group appreciates this

Children’s Hospital of Pittsburgh opportunity to comment on the Interim Final Rule with Request for
Pittsburgh, PA Comments entitled “Patient Protection and Affordable Care Act;
Stephen G Kahler, MD Requirements for Group Health Plans and Health insurance Issuers Under the
University of Arkansas for , ‘ ott ae
Medical Sciences Patient Protection and Affordable Care Act Relating to Preexisting Condition
Little Rock, AR Exclusions, Lifetime and Annual Limits, Rescissions, and Patient Protections”
Gary Siskin, MD 1
Albany Medical College (Final Rule and Proposed Rule).
Albany, NY
Andrew Morris, PhD, FRCPCH The FOD Group’s Mission is to connect and network with FOD Families and
Royal Manchester Children’s Hospital Professionals around the world and to provide emotional/grief support,

Manchester, UK

Family Stories, practical information about living with these disorders, and
Arnold Strauss, MD
__ Cincinnati Children's Research.Foundation. .. Medical Updates to inform families of new developments in screening, __
_ Cincinnati, OH diagnosis, research and ‘treatment. We also advocate for issues that directly
Barb Marriage, PhD, RD affect our Families, such as health care and insurance costs.
Ross Metabolics/Abbott Nutrition
Columbus, OH
Jahice Fletcher, MD, FRACP, FRCPA Our comments on the Interim Final Rule with Comments are focused on
Women and Children’s Hospital annual limits and the definition of “essential health benefits.”
North Adelaide, Australia
James Gibson, MD, PhD
Specially for Children
Austin, TX
. ‘The FOD Family Support Group is an all Volunteer Family-based Group and a tax-exempt S01¢3 Non-Profit Corporation

jonations are tax-deductible
‘Thank you to all that have donated over the years so that we may continue to provide our support and information to Families and interested professionals around the world.
Donations help with copying and postage costs, phone calls to new FOD Families (US and abroad), website fees, Conference costs,
‘as well as to provide for grants for future clinical and research activities by our FOD professionals.
Please make US checks out to: FOD Family Support Group and Mail to: PO Box 54 Okemos, MI 48805-0054
2 THANK YOU from ALL of us!



bee

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 may have exceptional medical needs and incur costs that exceed
the limits you outline in this Interim Final Rule. When these persons exceed their annual
limit, they often cannot afford life sustaining medical care. Persons with rare diseases
then find themselves 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. We have had several Families in that situation! Therefore, we ask that
you utilize your discretion to establish higher annual limits for persons with rare genetic
disorders.

Essential Health Benefits

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

Lifetime and annual limits apply to “essential health benefits” only. The Interim Firial
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 rare
genetic and metabolic disorders may 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 these services and items critical
to the medical management of persons with rare genetic disorders 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’Sécretary 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 anv questions regarding these comments.

Sincerely, Deb Lee Gould, MEd Director { Dataly Samed by Deb Lee Gould MEd, ~
FOD Family Support Group} ow. cneDeb Lee Gould, Md, Director,
‘deb@fodsupportorg

‘o=F00 Family Support Group, ou,
Okemon, MI —einallsdebefodsupport.org, US

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Deb Lee Gould, MEd
Director, FOD Family Support Group