_________________________________________________

August 16, 2010 

Office of Consumer Information 

 And Insurance Oversight 

Department of Health and Human Services 

Attention: OCIIO-9991-IFC 

Post Office Box 8016 

Baltimore, MD 21244-1850 

RE: OCIIO-9991-IFC 

Dear Sir or Madam: 

The Cystic Fibrosis Foundation appreciates the opportunity to comment on the interim 

final rules for health plans to retain grandfathered status under the Patient Protection and 

Affordable Care Act. We offer recommendations for modifications in the regulations 

that would respond to the needs of individuals with genetic diseases that pose serious 

health challenges and require complex daily care. 

In establishing grandfathered health plans and making them subject to some but not all of 

the statute’s reforms, the Affordable Care Act “balances its objective of preserving the 

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

the quality of health coverage.” In drafting the implementing regulations, the 

Departments of Health and Human Services, Labor, and Treasury confronted a 

significant challenge in providing plan sponsors and issuers flexibility to avoid premium 

increases while at the same time achieving the goal of ensuring that individuals who like 

their healthcare can keep it. We think the regulations significantly achieve that balance, 

but we would recommend some modifications. 

Prohibition against Eliminating Benefits for a Particular Condition and Prohibition 

Against Eliminating Any Element of Care 

We strongly support the rule that would prevent a plan from eliminating benefits for any 

particular condition. The preamble to the interim final rule gives the example of a plan 

eliminating all benefits for cystic fibrosis as an action that would result in loss of 

grandfathered status. We applaud the recognition in the rule of the burden that would be 

borne by those who are diagnosed with and being treated for orphan diseases if plans 

could eliminate benefits for such diseases. The language of the rule clearly establishes 

that such action would trigger loss of grandfathered status. 

Another critical part of the rule is that provision establishing that plans would use lose 

grandfathered status by eliminating benefits for any element of treatment for a condition. 

The treatment of cystic fibrosis is multi-disciplinary and includes management of many 

separate and distinct symptoms of the disease. Curtailing access to any part of the 
management of cystic fibrosis could be devastating to the health care of those living with 

and managing the disease. 

 

Impact of permissible increases in cost-sharing amounts 

We understand that the departments were attempting to provide sponsors and issuers 

flexibility by allowing them in the initial year under the rule to increase fixed-amount 

copayments by either 15 percent plus medical inflation or five dollars increased by 

inflation. However, these increases in deductibles, copayments, or out-of-pocket 

maximums would represent a substantial financial burden for those with chronic 

illnesses. Individuals would face a daily and monthly problem in managing the cost of 

care and related out-of-pocket expenditures and might also face a burden in terms of 

increased annual out-of-pocket maximums. We recommend a reduction in the percentage 

increase that would be permitted, above medical inflation. 

Notice to consumers regarding the protections provided by grandfathered plans 

The departments indicate that grandfathered plans will be required to inform participants 

and beneficiaries that the plan or coverage is “grandfathered” and must provide contact 

information for questions and complaints. The departments also ask for guidance about 

possible improvements in the language provided to consumers. 

We recommend that the notice to consumers include details about the protections in the 

Affordable Care Act that are not applicable to grandfathered plans, the protections of the 

Act that are applicable to grandfathered plans, and the standards that grandfathered plans 

must meet to maintain such status. This is a significant amount of detail for consumers, 

but we think it is a necessary part of the broad educational effort that the departments 

have undertaken to clarify the scope of the Affordable Care Act. 

Changes to prescription drug forumulary 

The departments seek specific input regarding the inclusion of changes to a prescription 

drug formulary on the list of changes that might cause loss of grandfathered status. We 

recommend that the departments define the scope of changes in a prescription drug 

formulary that would trigger loss of grandfathered status. For individuals with CF, the 

exclusion of specific drugs or categories or classes of drugs or the employment of 

aggressive formulary management tools might cause the plan to be altered to a degree 

that it would no longer represent the “healthcare the consumer wishes to keep.” If a plan 

were allowed to add categories or classes of drugs to formulary specialty tiers, those 

drugs might be beyond the reach of consumers. 

Changes to a plan’s provider network 

For individuals with CF, access to specialists with significant experience and training in 

CF care and continuity of care are critical to good outcomes. If plans are allowed to 

retain their grandfathered status while still making substantial changes in their provider 

network, those with CF may find that they no longer have access to the health care 

professionals with expertise in their disease. In the difficult balancing that the 

departments are undertaking, flexibility for plans and issuers is balanced against access to 

care and maintenance of quality care. However, by failing to address the issue of the 

provider network changes that grandfathered plans will be permitted to make, the 
departments have abandoned their attention to quality for those with serious and lifethreatening illnesses that require specialty care of high quality on a daily basis. 

********** 

The departments are to be commended for developing solid, workable, and flexible 

standards for health plans and insurance plans to meet in order to retain their 

grandfathered status. Although significant effort has been made to achieve balance in the 

approach to grandfathered plans, we urge some changes to ensure that grandfathered 

plans are offering consumers the health care that they wish to keep. We would 

recommend more modest allowable increases in fixed-amount copayments, limits on 

changes to the provider network or prescription drug formulary, and more aggressive 

notice to consumers regarding grandfathered plans. 

Sincerely, 

 

Robert J. Beall, Ph.D. 

President and Chief Executive Officer 

National Office 

6931 Arlington Road Bethesda, Maryland 20814 

(301) 951-4422 (800) FIGHT CF Fax: (301) 951-6378 Internet: www.cff.org E-mail: info@cff.org