CANCER LEADERSHIP COUNCIL 

A PATIENT-CENTERED FORUM OF NATIONAL ADVOCACY ORGANIZATIONS 

 ADDRESSING PUBLIC POLICY ISSUES IN CANCER 

August 16, 2010 

Office of Health Plan Standards and Compliance Assistance 

Employee Benefits Security Administration 

Room N-5653 

Department of Labor 

200 Constitution Avenue, NW 

Washington, DC 20210 

RE: RIN 1210-AB42: Interim Final Rules for Group Health Plans and Health Insurance Coverage 

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

Act 

The undersigned cancer patient, provider, and research organizations appreciate the opportunity to 

comment on the interim final rules establishing the standards for status as a grandfathered health plan. 

We commend the Departments of Health and Human Services, Labor, and Treasury for balancing the 

needs of plan sponsors and consumers in the interim rules. We recommend some modifications to the 

rules, as well as the issuance of guidance documents for plan sponsors; our recommendations are 

aimed at protecting and promoting health care access and quality. 

Elimination of benefits 

We are pleased that the interim final rules establish that the elimination of “all or substantially all 

benefits to diagnose or treat particular conditions” would trigger the loss of grandfathered status for a 

group health plan or health insurance coverage. The language in paragraph (g)(1)(i) also defines the 

elimination of “benefits for any necessary element to diagnose or treat a condition” as an action that 

would compel loss of grandfathered status. 

This protection of benefits will help ensure that individuals with cancer who remain enrolled in 

grandfathered plans would have access to the same care that they had access to prior to the enactment 

of the Patient Protection and Affordable Care Act. We recommend that additional guidance be 

provided to sponsors and issuers that would clarify that cancer care is multi-disciplinary, possibly 

requiring patient access to surgery, radiation therapy, and drug treatment, including drugs, biologics, 

and immunotherapies. For some cancer patients, access to all forms of cancer treatment may be 

necessary, and at no time in the course of cancer treatment and survivorship would restricting 

availability to any form or element of cancer treatment be acceptable. 

In addition, guidance should clarify that access to cancer drugs and biologics should include access to 

off-label uses consistent with the standards in the Medicare and Medicaid programs that ensure such 

off-label uses are evidence-based. 
- 2 - 

Changes in prescription drug formulary 

The interim final rule does not define changes in the prescription drug formulary as actions that would 

result in loss of grandfathered status. However, the departments do request comment on this issue. 

We strongly urge that the rule be modified to impose limits on restrictive changes in drug formularies, 

as such changes could easily result in loss of access to a “necessary benefit” for treatment or diagnosis 

of cancer. 

Changes in the drug formulary -- whether restricting access to particular drugs or to classes or 

categories of drugs -- could block cancer patient access to necessary drugs for treatment of their 

specific diagnosis. Such changes would certainly alter the nature of the health care plan on which 

cancer patients have relied. 

The rules should also be amended to place restrictions on the use of formulary management tools, 

including the utilization of specialty tiers for certain cancer drugs and biologics. Placing cancer drugs 

on specialty tiers with significant coinsurance requirements might effectively block access to a 

“necessary element” of cancer treatment. 

The provider network 

The interim final rules also fail to address the effect of changes in the provider network on a plan’s 

grandfathered status. We recommend that limits be placed on the scope of changes that could be made 

to a plan’s provider network, or in the alternative, that health plans or insurance coverage should 

guarantee continuity of care for those receiving treatment for cancer and other serious and lifethreatening illnesses. Such rules would balance the desire of plans to retain grandfathered status and 

the needs of plan enrollees with serious and life-threatening illnesses for reliable access to high-quality 

care. 

Coverage of routine patient care costs in clinical trials 

The Affordable Care Act imposes a requirement, effective in 2014, that health plans cover the routine 

patient care costs for those enrolled in cancer clinical trials. This provision will ensure that cancer 

patients can enroll in cancer research studies, which often represent their best treatment option. This 

benefit will also encourage cancer clinical research that answers fundamental questions about the 

effectiveness of new cancer treatments and identifies quality cancer care. 

We encourage you to take action to make the Affordable Care Act clinical trials provision a 

meaningful protection for all cancer patients in advance of 2014. We urge the following actions: 

 Guidance to grandfathered plans that the option to receive care in a cancer clinical trial, 

identified by the patient and care team as an appropriate treatment choice, is a necessary 

element of cancer care and may not be eliminated as a benefit if the plan has included such 

coverage in the past. 

 Encouragement to those plans that have not provided clinical trials coverage to do so 

voluntarily. Some plans have agreed to such a coverage policy, which they see as advancing 

CONTACT: 2446 39TH STREET NW · WASHINGTON, D.C. 20007 

Phone: 202-333-4041 · www.cancerleadership.org 
- 3 - 

CONTACT: 2446 39TH STREET NW · WASHINGTON, D.C. 20007 

Phone: 202-333-4041 · www.cancerleadership.org 

the state of knowledge about cancer care and therefore useful not just to those enrolled in trials 

but to all cancer patients. Others should be encouraged to follow that example. 

 Comparison tools, on www.healthcare.gov and in other educational materials, which permit 

consumers to assess plans for their coverage of clinical trials. 

Consumer education regarding grandfathered plans 

The departments have to date done an impressive job of posting educational materials online, 

conducting educational meetings and seminars, and employing other means of providing basic 

information about the Affordable Care Act. The preamble to the interim rules requests feedback on the 

materials that grandfathered plans must provide to consumers. We recommend that these documents 

provide detail about the operation of grandfathered plans and the regulatory requirements that will 

apply to these plans. It will not be a simple task to create easily accessible consumer materials that 

explain the rather complicated regulatory structure of the Affordable Care Act. Nonetheless, we 

recommend that more detail be provided to consumers than seems to be anticipated in the interim 

rules. 

We appreciate the opportunity to comment on the interim final rules on grandfathered plan status. We 

applaud the work of the departments in developing these rules, which for the most part do an excellent 

job of balancing the needs of plan sponsors and issuers and the consumers who will rely on coverage 

through a grandfathered plan. 

Sincerely, 

Cancer Leadership Council 

American Society for Radiation Oncology 

American Society of Clinical Oncology 

Bladder Cancer Advocacy Network 

C3: Colorectal Cancer Coalition 

Cancer Support Community 

The Children's Cause for Cancer Advocacy 

Coalition of Cancer Cooperative Groups 

International Myeloma Foundation 

Lance Armstrong Foundation 

The Leukemia & Lymphoma Society 

Lymphoma Research Foundation 

Multiple Myeloma Research Foundation 

National Coalition for Cancer Survivorship 

National Lung Cancer Partnership 

National Patient Advocate Foundation 

Ovarian Cancer National Alliance 

Pancreatic Cancer Action Network 

Prevent Cancer Foundation 

Sarcoma Foundation of America 

Susan G. Komen for the Cure Advocacy Alliance 

Us TOO International Prostate Cancer Education and Support Network