The Honorable Kathleen Sebelius July 12, 2010

Secretary,

Department of Health and Human Services

200 Independence Avenue, S.W. 

Washington, DC 20201

Re: OCIIO-9991-IFC; Group Health Plans and Health Insurance Coverage Relating to 

Status as a Grandfathered Health Plan Under the Patient Protection and Affordable 

Care Act 

Dear Secretary Sebelius, 

On behalf of American Society of Clinical Oncology (ASCO), I am pleased to submit 

these comments in response to the interim final rule issued in the Federal Register

entitled, “Group Health Plans and Health Insurance Coverage Relating to Status as a 

Grandfathered Health Plan Under the Patient Protection and Affordable Care Act” 

(OCIIO-9991-IFC). With more than 28,000 members, ASCO is the leading medical 

society for specialists involved in cancer treatment and research. We commend the 

Departments of Health and Human Services, Labor and the Treasury for developing 

this interim final rule, which provides clarification regarding the status of 

grandfathered health plans. 

Health plans should be encouraged to enhance the scope of covered benefits 

whenever possible, and ASCO strongly agrees with the Departments that health plans 

should not lose grandfathered status as a result of adding benefits to an existing 

grandfathered plan. We support the language in the preamble of the interim final rule 

that states, “These interim final regulations will generally permit, for example, plans 

and issuers to make voluntary changes to increase benefits, to conform to required 

legal changes, and to adopt voluntarily other consumer protections in the Affordable 

Care Act.” We urge the Departments to highlight this important clarification in all 

notices and guidance documents, emphasizing the desirability of voluntarily adopting 

consumer protections that will become mandatory for non-grandfathered plans, such 

as the coverage of the routine costs associated with clinical trials. This will help ensure 

that plans can continue to meet the changing needs of their participants, which is 

especially important during this period of rapid innovation in the field of medicine. 

ASCO also commends the Departments for affirming that health plans will lose 

grandfathered status if the plans eliminate all or substantially all benefits to diagnose 

or treat a particular disease or condition. Because of the potential that health plans 

might employ undesirable cost-cutting strategies, ASCO recommends that the 

Departments describe scenarios in which this safeguard would be triggered to protect
The Honorable Kathleen Sebelius

July 12, 2010

consumers with cancer. Specifically, we urge the Departments to include the following examples: 

• If a health plan eliminates coverage for the routine costs associated with clinical trials.

(This addition will also benefit consumers with other life-threatening diseases.)

• If a health plan eliminates coverage for evidence-based, off label usage of drugs and 

biologics for anticancer regimens. 

• If drugs or biologics that are part of an evidence-based anticancer regimen are either 

removed from a health plan formulary or moved to a different payment tier, thus 

increasing a patient’s copayment responsibility.

• If a health plan institutes more restrictive limits to the number of chemotherapy 

treatments or hospital admissions that a patient with cancer can receive.

• If a patient’s physician (who is participating in a preferred provider network) has agreed 

to use insurer-designated treatment pathways and the patient is denied coverage for an 

indicated pharmaceutical agent because it is not on the pathway but would otherwise 

have been covered by the plan. 

In the case of individuals with cancer, meaningful access to cancer care requires coverage of the routine 

medical costs associated with participation in clinical research, which is otherwise required under the 

new law. As you are aware, clinical trials provide important options for the treatment of individuals with 

cancer and other life-threatening diseases and promote advancement in scientific discovery and 

knowledge. In fact, such coverage does not significantly impact the premiums or aggregate costs of 

providing health insurance. 

We encourage the Departments to take steps to urge grandfathered plans to voluntarily provide 

coverage for clinical trial participation. The Departments can do this by issuing public statements on the 

topic and by adding “clinical trials coverage” as a point of comparison on the website

(www.healthcare.gov) the Department is developing to enable consumers to compare health plans.

ASCO also encourages HHS to issue additional guidance regarding how health plans will be monitored 

for breeches that would cause a plan’s loss of grandfathered status. This guidance should indicate how 

patients and providers can report coverage concerns. A transparent and efficient reporting and review 

process will ensure that health plans are held accountable. The reporting should not overly burden 

patients and providers. 

ASCO notes that many health plans do not have a transparent mechanism of articulating specific 

services that are covered by the plan. This may present challenges in determining what coverage was in 

effect on March 23, 2010. ASCO recommends that language be added to the rule indicating that when 

coverage documentation is ambiguous, the Department will determine what services must be covered 

based on past patterns of coverage and a reasonable interpretation of the plan’s documents. 

* * * *
The Honorable Kathleen Sebelius

July 12, 2010

We appreciate the important collaboration and efforts by the Departments of Health and Human 

Services, Labor and the Treasury to address these important issues. Overall, we commend this interim 

final rule and encourage you to contact Shelagh Foster, ASCO’s Director of Government Relations 

(shelagh.foster@asco.org or 571-483-1612) if you have any questions or would like to discuss these 

comments in greater detail.

Thank you for your consideration,

George W. Sledge, Jr., MD

President

American Society of Clinical Oncology

GWS:ab