August 16, 2010

The Honorable Kathleen Sebelius 

Secretary 

U.S. Department of Health and Human Services 

Hubert H. Humphrey Building

200 Independence Avenue, SW 

Washington, DC 20201

RE: OCIIO – 9991 – IFC: Interim Final Rules for Group Health Plans and Health 

Insurance Coverage Relating to Status as a Grandfathered Health Plan

Dear Secretary Sebelius: 

National Patient Advocate Foundation (NPAF) would like to thank you for the opportunity 

to submit comments on the 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. 

NPAF is a non-profit organization dedicated to improving access to healthcare services 

through both federal and state policy reform. Our mission is to be the voice for millions of 

patients who have sought care after a diagnosis of a chronic, debilitating or life-threatening 

illness. The advocacy activities of NPAF are informed and influenced by the experience of 

patients who receive direct, sustained services from Patient Advocate Foundation (PAF), 

which provides professional case management assistance to patients. In 2009, PAF resolved 

55,384 patient cases and received four million additional inquires from patients nationally 

from all 50 states.

Changes to a Prescription Drug Formulary

NPAF would like to comment on the magnitude of changes to a prescription drug formulary 

that should result in a plan losing its grandfathered status. In 2009, almost 21 percent of 

privately insured patients contacting PAF reported pharmaceutical access/co-payment issues 

as their primary healthcare access issue. Over the years, PAF professional case managers 

have documented changes to drug formularies that result in significantly reduced 

prescription drug benefits and/or higher out-of-pocket spending on behalf of the patient. 

NPAF recommends that an insurance plan lose its grandfathered status if a patient’s out-ofpocket spending for any pharmaceutical agent increases by a cost sharing amount in excess

of medical inflation. 

A growing number of health plans are establishing specialty tiers for prescription drugs that 

treat diseases such as HIV/AIDS, cancer, and multiple sclerosis. Under the standard 

copayment structure, a patient may pay $55 for a $3,000 multiple sclerosis drug but is 

charged 25 – 33% in coinsurance under a specialty tier. Health plans should be limited in 
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their ability to create additional specialty tiers and/or their ability to move additional drugs to 

specialty tiers if they wish to maintain grandfathered status. In addition, health plans often 

use utilization management tools, such as step-therapies, prior-authorization etc., to limit 

patient access to newer, more expensive pharmaceutical agents. NPAF recommends that 

the imposition of additional utilization management tools result in a loss of grandfathered 

status. 

NPAF recognizes the interim final rule provides that plans shall cease to be grandfathered if 

the plan imposes an overall annual limit on the dollar value of benefits that was not in place 

prior to March 23, 2010. However, NPAF recommends that a plan lose grandfathered 

status if they impose an annual limit on the dollar value of prescription drug benefits which 

was not in place prior to March 23, 2010. For plans with annual limits prior to March 23, 

2010, NPAF recommends those plans shall lose grandfathered status if they decrease the 

dollar value of the annual limit. 

Elimination of Benefits

NPAF recommends that guidance should clarify that access to treatments (drugs, biologics, 

surgeries, etc) for illnesses including cancer 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.

Changes to Provider Network

NPAF recommends additional guidance in order to clarify that grandfathered plans must 

maintain a robust network of providers as required in PPACA for plans operating in the 

exchanges. Reducing the network of providers generally or limiting access to certain 

specialists should be prohibited in order for a plan to maintain grandfathered status. An 

appropriate balance among providers must be guaranteed by the grandfathered plan. 

Coverage of Routine Patient Care Costs in Clinical Trials

PPACA requires health plans to cover the routine patient care costs for those enrolled in 

cancer clinical trials beginning in 2014. NPAF urges the following actions so that the clinical 

trials provision is a meaningful protection for all cancer patients in advance of 2014:

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 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

NPAF supports the disclosure requirement for grandfathered plans that is part of the 

interim final regulations and encourages that grandfathered plans be required to list and 

describe the various consumer protections that do not apply to the plan because it is 

grandfathered. This disclosure requirement is especially important to patients with a private, 

grandfathered individual health insurance policy which is allowed under the rule to impose 

preexisting condition exclusions or other discrimination based on health status. Finally, 

NPAF recommends that a plan lose its grandfathered status is they fail to notify an enrollee 

they are approaching a benefit maximum. 
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We thank you for the opportunity to comment from the patient’s perspective on the rules 

relating to the status of grandfathered plans. We would be pleased to respond to any 

questions about our recommendations that may arise during the implementation of the 

PPACA. 

Respectfully submitted,

Nancy Davenport-Ennis

President and Chief Executive Officer