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August 6, 2010

Jay Angoff, Director

Office of Consumer Information and Insurance Oversight

Department of Health and Human Services

Attention: OCIIO-9991-IFC

P.O. Box 8016

Baltimore, MD 21244-1850

RE: Comments on Interim Final Rules for Group Health Plans and Health 

Insurance Coverage Relating to Status as Grandfathered Health Plan under the 

Patient Protection and Affordable Care Act

Dear Director Angoff:

The National Organization for Rare Disorders (NORD), and the American Plasma 

Users Coalition (A-PLUS) are pleased to submit comments on the Interim Final Rules for 

Group Health Plans and Health Insurance Coverage Relating to Status as Grandfathered 

Health Plan under the Patient Protection and Affordable Care Act (“Affordable Care Act”), 

which was published in the Federal Register (Vol. 75, No. 116) on June 17, 2010.

NORD was founded in 1983 to advocate for the enactment of the Orphan Drug Act, 

and remains the leading advocate for the 30 million patients with the estimated 7,000 

known rare diseases. The A-PLUS is a coalition of national patient organizations created to 

address the unique needs of over 125, 000 patients with rare diseases that use life-saving 

plasma protein therapies.

We appreciate the efforts of the Office of Consumer Information and Insurance 

Oversight (OCIIO) to provide guidance on the definition and limits of a grandfathered 

health plan. As you are aware, the Affordable Care Act provides that certain group health 

plans and health insurance coverage existing as of March 23, 2010 (the date of enactment) 

are only subject to certain insurance reform provisions. We are very pleased that the 

Affordable Care Act applies the insurance reform provisions related to lifetime and annual 

limits, preexisting condition exclusion, and rescissions to grandfathered health plans. 

NORD and A-PLUS support the conditions set forth in the interim final rule that limit 

a health insurance plan’s ability to maintain grandfather status. We support the rights of 

patients to maintain their existing coverage. However, health insurers should not be 
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permitted to abuse the exemption for grandfathered health plans to avoid critical insurance 

reforms. We believe the interim final rules strikes a proper balance between preserving 

the ability to maintain existing coverage with the goals of expanding access to and 

improving the quality of health coverage. 

We are pleased to offer our suggestions and comments on the following provisions in 

the rules:

1. Annual Limits

The interim final rules set restrictions on the imposition of new or modified annual 

limits by a plan, or group or individual health insurance coverage. NORD and A-PLUS 

strongly support these restrictions which limit the ability of plans and coverage to impose 

or modify annual limits based on whether they imposed annual limits and/or lifetime limits 

prior to the enactment of the Affordable Care Act. 

As you are aware, lifetime limits are eliminated for plans years beginning on or after 

September 23, 2010, while annual limits are not eliminated until January 1, 2014. Due to 

the delay in the elimination of annual limits, we are concerned that insurers will impose or 

decrease such limits to compensate for the elimination of lifetime limits. The restrictions 

set forth in the rules are an important step in prohibiting this practice.

2. Disclosure of Grandfather Status

Under the interim final rules, a plan or health insurance coverage must include a 

statement in any plan materials provided to a participant or beneficiary describing benefits 

that the plan or coverage believes it is a grandfathered plan. The model language provided 

in the rules does not require plans to list and describe each consumer protection that: (i) 

does not apply because of the grandfather exemption, or (ii) does apply regardless of the 

grandfather exemption.

NORD and A-PLUS strongly believe that plans and health insurance coverage should list 

and describe each consumer protection affected by its grandfather status. The majority of 

Americans are unaware of all the consumer protections in the Affordable Care Act. 

According to a Kaiser Family Foundation Health Tracking Poll (conducted April 9-14, 

2010), 55 percent of Americans feel “confused” about health reform, and 56 percent say 

they don’t yet have enough information to understand how health reform will affect them 

personally1. Given the critical importance of consumer protections, particularly for 

patients with rare disorders, plans should be required to list and describe all the applicable 

and non-applicable consumer protections in their statements.

NORD and A-PLUS suggest that the model language list all consumer protections that 

either apply or do not apply to grandfathered plans. For example, in addition to noting that 

the Employee Benefits Security Administration (EBSA) website has a table summarizing 

 1 See http://www.kff.org/kaiserpolls/8067.cfm.
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which protections do and do not apply to grandfathered health plans, we recommend 

including the EBSA table or the table drafted by the National Association of Insurance 

Commissioners (NAIC) (see attached) in the model language.

3. Prescription Drug Formulary

In addition to the changes identified in the rules which would cause a plan or health 

insurance coverage to no longer be considered a grandfathered health plan, we support the 

loss of grandfather status if a plan sponsor or issuer should make changes to the 

prescription drug formulary.

Patients with rare diseases who rely on orphan drugs and/or biologics are sometimes 

temporarily or permanently denied access to orphan drugs and/or biologics because plans 

tend to exclude them from drug formularies due to low demand and/or high cost. Orphan 

drugs and/or biologics that treat patients with rare diseases often represent the first or 

only effective treatment for an individual with a rare disease. 

Changes, such as removal of an orphan drug and/or biologic, from a plan’s 

prescription drug formulary can have a drastic impact on rare disease patients who rely on 

life-saving medications. These changes constitute the type of substantial change to overall 

benefit design that should cause a plan or coverage to lose its grandfathered status.

Thank you for the opportunity to submit comments. We look forward to working with 

you on the implementation of the Affordable Care Act, and ensuring that patients with rare 

disorders have access to quality, affordable health care.

For additional information, please contact Diane Edquist Dorman, NORD Vice President 

for Public Policy (ddorman@rarediseases.org) or Kisa Carter, HFA Public Policy Director 

(k.carter@hemophiliafed.org). 

Sincerely,

American Plasma Users Coalition2

National Organization for Rare Disorders

 2 American Plasma Users Coalition (A-PLUS) membership includes: Alpha-1 Association, Alpha-1 

Foundation, Committee of Ten Thousand, GBS/CIDP Foundation International, Hemophilia Federation of 

America, Immune Deficiency Foundation, Jeffrey Modell Foundation, National Hemophilia Foundation, 

Patient Services Incorporated