THE

NATIONAL

COALITION

FOR
CANCER

RESEARCH

Member Organizations
Albert and Mary
Lasker Foundation

American Association
for Cancer Research

American Cancer Society, Inc

American College

of Radiology
American Society for
Therapeutic Radiology
and Oncology

American Society of
Clinical Oncology

American Society
of Hematology

Association of American
Cancer Institutes

Cancer Research
and Prevention Foundation

Cancer Treatment
Research Foundation

Candlelighters Childhood

Cancer Foundation

Coalition of Cancer
Cooperative Groups

CureSearch National
Childhood Cancer Foundation

International Cancer
Advocacy Network

August 16, 2010

U.S. Department of Labor
Office of Health Plan Standards
and Compliance Assistance
Employee Benefits Security Administration
Room N-5653
Attn: RIN1210-AB42
200 Constitution Avenue NW
Washington, DC 20210

Office of Consumer Information and Insurance Oversight
Department of Health and Human Services

Attn: OCIIO-9991-IFC

P.O. Box 8016

Baltimore, MD 21244-1850

Internal Revenue Service
CC:PA:LPD:PR (Reg-118412-10)
Room 5205

P.O. Box 7604

Ben Franklin Station

Washington DC 20004

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

Ladies and Gentlemen:

The National Coalition for Cancer Research (NCCR) is pleased to submit these
comments in response to the interim final rules 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

International Myeloma Foundation\ ot? (PPACA) (OCIIO-9991-IFC).

Kidney Cancer Association

‘he Leukemia and
Lymphoma Society

‘The Lustgarten Foundation for
Pancreatic Cancer Research

Oncology Nursing Society

Pancreatic Cancer Action Networ

PanCAN

Prostate Cancer Foundation
Radiation Research Society
Society of Nuclear Medicine

The Society of
Gynecologic Oncologists

‘The V Foundation for
Cancer Research

The NCCR is a coalition of cancer research, cancer care and lay groups, and
foundations representing cancer survivors, adults and children with cancer and
their families, cancer researchers, nurses and physicians, and cancer hospitals,
centers, clinics and specialized research institutions. The NCCR directs its efforts

jat educating public policy makers and legislators about the impact of specific

legislation on cancer research. Specifically, the NCCR advocates for Federal
legislation and regulations that will enhance and expand basic, translational and
clinical research and ensure that the infrastructure and reimbursement
mechanisms are in place to support the translation of research from the laboratory
to the bedside. The NCCR supports these goals in their broadest terms,
emphasizing national priorities essential to progress in cancer research, treatment,
early detection and prevention of cancer.

1050 K STREET, N.W. SUITE 315 WASHINGTON, D.C. 20001 (202) 442-3710 (202) 638-0604 FAX


National Coalition for Cancer Research Recommendations

The implementation of Section 2709 of the PPACA, “Coverage for Individuals Participating in
Approved Clinical Trials,” is of paramount importance to NCCR. As such, we will limit our
recommendations on the Interim Final Rules Relating to Status of a Grandfathered Health Plan
under PPACA to clinical trial coverage.

We strongly support the provisions of the Interim Final Rules that permit health plans to add
benefits to an existing grandfathered plan, or to voluntarily adopt consumer protections that will
become necessary for non-grandfathered plans, without forfeiting its grandfathered status. We
encourage the Departments to clarify and emphasize this point with respect to a plan adding
coverage of routine patient costs for clinical trial participants. We also encourage the
Department of Health and Human Services (HHS) to provide information on this topic in written
communications to consumers and by including “Coverage of Clinical Trials” as a point of
health plan comparison when consumers utilize the HHS healthcare website
(www.healthcare.gov). Furthermore, we strongly encourage the Departments to specifically state
that elimination of coverage for routine patient costs associated with clinical trial participation
would, in fact, result in the immediate loss of grandfathered status of the plan.

As you are aware, for patients with cancer and others struggling with life-threatening illnesses,
standard therapy may not be effective, and frequently the best therapies are available only
through participation in a clinical trial. Unfortunately, access to cutting-edge treatment through
clinical trials is often denied, as many health plans refuse to cover routine patient care costs on
the grounds that the care is “experimental.”

We also understand some plans that do not generally provide coverage of routine patient costs
for clinical trial participants have provided coverage of such costs on a case-by-case basis.
While we strongly encourage all health plans to voluntarily adopt the provisions of Section 2709
of PPACA, we do not believe that a plan should be ceased to be grandfathered if it provides such
coverage for individual plan participants on a case-by-case basis when such coverage is not
provided for in the plan language.

We acknowledge and appreciate the tremendous manpower and monetary costs associated with
implementation of PPACA. However, we are concerned the Interim Final Rules for
grandfathered plans do not provide adequate guidance on how such plans will be monitored to
determine initial compliance, to determine future compliance and to avoid potential abuse. We
believe it is imperative that the final regulations contain additional guidance on how the
Departments will monitor health plans and on the mechanism for adopting non-grandfathered
plan requirements if the health plans are found to be in violation. This guidance should also
include information regarding how consumers and/or providers can report potential breeches that
could cause the loss of a plan’s grandfathered status, including changes in clinical trials coverage
determinations.

Finally, we encourage the Departments to require all health plans (grandfathered and non-
grandfathered) to provide consumers with understandable, unambiguous information regarding
coverage or non-coverage of routine patient costs associated with clinical trial participation. In
order to increase the transparency of the health care system, this information regarding coverage
of clinical trials should be included with additional consumer information regarding
grandfathered health plans. Such information should include (i) a comprehensive explanation of
grandfathered plan status, (ii) information regarding actions that would trigger the loss of


grandfathered status, (iii) a listing of PPACA provisions that are and are not applicable to
grandfathered plans, including clinical trials coverage (iv) affirmatively stating that plans may
add additional consumer protection benefits without loss of grandfathered status and (v) a means
by which consumers can obtain information regarding the grandfathered status of their own
health plan.

Conclusion

While we remain concerned that even the limited grandfathering status provision of PPACA
could have the unintended consequence of undermining the overall objective of health care
reform, the National Coalition for Cancer Research agrees that the Interim Final Rules reflect the
intent of the grandfathering status provision in PPACA. We commend the Departments for their
collaborative efforts to develop the Interim Final Rules, which provide clarity to consumers,
researchers and providers regarding the status of grandfathered health plans.

At a time when more than 400 anti-cancer therapeutics are in various stages of clinical
development, it is essential to preserve and expand our nation’s robust clinical trial system. We
believe the recommendations contained within this letter will help achieve these objectives and
also provide essential information and assistance to clinical trial participants.

We thank you for the opportunity to provide these comments and respectfully request they be
given full and fair consideration as the Departments proceed with additional rulemaking
regarding group health plans and health insurance coverage relating to status as a grandfathered
health plan under the Patient Protection and Affordable Care Act.

Sincerely,

American Association for Cancer Research
American Cancer Society Cancer Action Network
American College of Radiology
American Society of Clinical Oncology
American Society of Hematology
American Society for Radiation Oncology
Association of American Cancer Institutes
Gateway for Cancer Research
Candlelighters Childhood Cancer Foundation
Coalition of Cancer Cooperative Groups
CureSearch Childhood Cancer Foundation
Friends of Cancer Research
International Cancer Advocacy Network
International Myeloma Foundation
Kidney Cancer Association
Leukemia and Lymphoma Society
The Lustgarten Foundation
Oncology Nursing Society
Pancreatic Cancer Action Network
Prevent Cancer Foundation
Prostate Cancer Foundation
Society of Gynecologic Oncologists
V Foundation for Cancer Research