_________________________________________________ 

August 27, 2010 

The Honorable Kathleen Sebelius 

Secretary 

Department of Health and Human Services 

200 Independence Avenue, SW 

Washington, DC 20201 

RE: OCIIO-9994-IFC 

The Honorable Hilda Solis 

Secretary 

Department of Labor 

200 Constitution Avenue, NW 

Washington, DC 20210 

RE: RIN 1210–AB43 

The Honorable Douglas Shulman 

Commissioner 

Internal Revenue Service 

1111 Constitution Ave NW, 

Washington, DC 20224 

RE: REG–120399–10 

Dear Secretary Sebelius, Secretary Solis, and Commissioner Shulman: 

On behalf of the Cystic Fibrosis Foundation and 30,000 patients with CF across the 

country, I am pleased to submit the following comments on the interim final rules 

regarding preexisting condition exclusions, lifetime and annual limits, rescissions, and 

patient protections. We applaud the Departments of Health and Human Services, Labor, 

and Treasury for their timely issuance of interim final regulations implementing critical 

provisions of the Patient Protection and Affordable Care Act. We agree with the 

departments that the interim final rules at hand are particularly important because they 

implement provisions of the Affordable Care Act that offer protections to many with 

chronic and serious health conditions who require significant medical care, make large 

expenditures for care, and encounter special risk of loss of insurance coverage. 

________________________________________________________________________ 

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
We commend the departments for a clear and forceful description of the benefits of these 

interim final rules, including 1) reductions in mortality and morbidity, 2) reduction in 

medical risk, 3) improved workplace productivity, and 4) reductions in uncompensated 

care and resulting cost-shifting. 

We recommend several modifications of the regulations. While discussed in greater detail 

below, these modifications include extending the minimum annual and lifetime limits, 

increasing them for each year of the three-year phased transition to 2014, when annual 

limits will be prohibited; clarification of the protections against rescissions of benefits 

that will be afforded consumers and additional protections to consumers who find 

themselves in the position of suffering a rescission of employer-sponsored coverage due 

to action by the plan sponsor; additional demonstrations and pilot projects to test and 

evaluate case management and care coordination for those with chronic and serious 

illnesses. 

We urge a continued strong emphasis on consumer education about the Affordable Care 

Act, to ensure that consumers take appropriate advantage of the law’s protections and 

benefits. 

Those with cystic fibrosis (CF) and their families will be clear beneficiaries of these 

benefits, as described below. 

Preexisting Condition Exclusions 

Those with CF and their families are at substantial risk of being uninsured as a result of 

the application of preexisting condition exclusions. Those with CF who experience gaps 

– which may be for extended periods of time – in coverage may forgo critical health care 

and experience significant deterioration in lung function and overall health status as a 

result. The impact on their own health and the overall cost to the health care system for 

care delayed may be great. The extension of dependent coverage in the Affordable Care 

Act offers special promise to young adults with CF who have previously found 

themselves confronting loss of insurance coverage at a time when they were seeking to 

become self-supporting and enter the workforce. The extension of preexisting condition 

protections to those under age 19 enrolled in certain plans and policies will also provide 

some relief to families with young children and teenagers with CF. 

The commentary to the interim final rule explains that the extension of preexisting 

condition limits will not apply to individual policies that enjoy grandfathered status. The 

departments recommend that a parent with a child who is excluded from coverage under 

a grandfathered individual plan consider terminating the existing plan and purchasing a 

new individual plan that would be subject to the preexisting condition rules. Families 

with a child with CF have by necessity become sophisticated health care consumers and 

purchasers of health insurance coverage. However, the Affordable Care Act imposes 

new regulatory requirements and important patient protections that will not be 

immediately understood by CF families and others. We urge that the Departments 

continue their aggressive public education efforts regarding the Affordable Care Act, to 
be complemented by the efforts of many states, to ensure that consumers are aware of all 

opportunities to improve their access to affordable health care, such as the purchase of 

new coverage through an individual plan. 

We note that the commentary to the rules also identifies a population of children whose 

parents are offered employer-sponsored insurance but are unable to afford that insurance. 

The departments make clear that the interim rules do not address the issue of affordability 

of coverage, meaning that some will remain outside the insurance market because of 

inability to purchase employer-sponsored insurance. We understand that addressing this 

issue is outside the scope of the interim final rules, but we appreciate the 

acknowledgement by the departments of those whose insurance needs will not be 

addressed immediately by the Affordable Care Act or the interim final rules. 

Annual and Lifetime Limits 

We understand the need to balance individuals’ access to essential health benefits against 

the potential for premium increases for all plans and policies in developing the three-year 

phased approach to restricted annual limits. However, we have concerns about the 

minimum limits that are included in the interim final rule. For the policy or plan years 

beginning on or after September 23, 2010, but before September 23, 2011, the minimum 

limit is $750,000. This is a limit that may be reached by individuals with CF in any year 

when they must be hospitalized for pulmonary exacerbations of CF as well as by those 

with CF who have lung transplants. The minimum limits for 2011-2012 and 2012-2013, 

although greater, might also be reached by a small number of those with CF. 

We admit that the number of individuals reaching the minimum limits established by the 

interim final rule will be small. As the Departments recognize throughout the 

commentary to the rules, the benefits of the protections outlined in the rules are enjoyed 

by a relatively limited population. As a result, the cost of the benefits – and the potential 

impact on premiums – will also be limited. 

Because of the limited overall fiscal impact associated with such a change, we urge the 

Departments to reconsider the minimum limits, increasing them for each year of the 

three-year phased transition to 2014, when annual limits will be prohibited. 

Rescissions of Coverage 

We are pleased that the interim final rules clarify the protections against rescissions of 

benefits that will be afforded consumers and define the actions that might trigger 

rescissions. The interim rules make clear that rescissions would be permitted only if 

there was fraud or an intentional misrepresentation of material fact. The commentary 

provides examples that further explain the grounds for rescissions. 

According to language in the preamble, an individual consumer might be at risk for 

rescission on the basis of an action by a plan sponsor. The preamble states, “Thus, if a 

plan sponsor seeks coverage from an issuer for an entire employment-based group and 

makes representations, for example, regarding the prior claims experience of the group, 
the standards of these interim final regulations would also apply.” Individuals with CF 

who were included in such an employment-based group might find themselves without 

access to insurance coverage at an affordable price. It seems that the only protections 

available to such individual would be thirty days’ notice of the rescission and the 

possibility of seeking coverage in the individual market. However, such coverage may 

not be readily affordable. 

We understand that any misrepresentation by the employer would relate to the contractual 

relationship between the sponsor and issuer and that the language of the Affordable Care 

Act related to intentional misrepresentation of material fact is relevant. We urge that the 

departments consider whether there is any option, consistent with the Affordable Care 

Act, for providing protections to consumers who find themselves in the position of 

suffering a rescission of employer-sponsored coverage due to action by the plan sponsor. 

Patient Protections Related to Choice of Physicians 

We are pleased that the Affordable Care Act and the interim final rules protect the rights 

of patients to designate a primary care physician who participates in the plan, choose a 

pediatrician as a primary care physician, and access emergency services at in-network 

rates. The departments make a strong case for these patient protections, citing the 

positive impact of designating a primary care physician on quality of care, patient 

compliance with care, and coordination of all elements of care. The benefits related to 

patient choice of physician and care coordination are very strong, and we encourage 

additional demonstrations and pilot projects to test and evaluate case management and 

care coordination for those with chronic and serious illnesses. The CF Foundation has a 

strong clinical care network supported by practice guidelines and routine reporting of 

patient outcomes in a readily accessible patient care registry. These efforts have 

supported significant quality improvements in CF care and should be expanded and 

replicated in other chronic disease areas. We believe the Affordable Care Act creates the 

opportunity for experimentation in health care delivery and urge that this opportunity be 

seized. 

***** 

We commend the departments for the interim final rules, which offer important 

protections to individuals with serious illnesses who require significant health care and 

have substantial health care expenses. 

Sincerely, 

 

 

Robert J. Beall, Ph.D. 

President and Chief Executive Officer