Section 1. PURPOSE

This notice requests public comments on the implementation of provisions of the Patient Protection and Affordable Care Act, P.L. 111–148, (Affordable Care Act) to fund comparative clinical effectiveness research relating to patient-centered outcomes. The Affordable Care Act includes provisions that promote research to evaluate and compare health outcomes and the clinical effectiveness, risks, and benefits of medical treatments, services, procedures, drugs, and other strategies or items that treat, manage, diagnose, or prevent illness or injury.

As required by the Affordable Care Act, a nonprofit corporation - the Patient-Centered Outcomes Research Institute (Institute) - was established to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing comparative clinical effectiveness research. The Affordable Care Act provides that the Institute will not be an agency or establishment of the United States Government, and will be funded by a Patient-Centered Outcomes Research Trust Fund (Trust Fund). The Trust Fund, in turn, is to be funded in part by fees to be paid by issuers of health insurance policies and sponsors of self-insured health plans.

The Department of the Treasury (Treasury) and the Internal Revenue Service (Service) intend to publish proposed regulations implementing and providing guidance on the statutory requirements applicable to issuers and plan sponsors that pay those fees. To inform the development of the proposed regulations, this notice invites comments on how the fees should be determined and paid, including comments on several possible rules, safe harbors, and issues outlined below. Accordingly, while

this notice does not provide guidance, it describes potential guidance that Treasury and the Service expect to propose to implement the new fees and seeks comments on this potential guidance.