PCORI's Budget Doubles in 2014

According to a Congressional Quarterly article published on the Commonwealth Fund's website, the 2014 budget for the Patient-Centered Outcomes Research Institute (PCORI) will increase from $320 million in 2013 to $650 million next year because of a surcharge on Medicare premiums and premiums charged by commercial insurers and employer plan sponsors under the health law. Some of the money will focus on product-to-product comparisons, according to a new analysis by the California Healthcare Institute. But most of it won't, instead paying for studies on how to improve teamwork among doctors, for example, or the ways in which doctors communicate with patients about potential treatments. Insiders refer to such approaches as "systems interventions."

That differs from the original vision many promoters of comparative effectiveness research had for the field—one in which studies would be focused predominantly on investigating which drug, device or other treatment worked best for a particular condition. The two fields—treatment comparisons and system interventions—can work hand in hand. However, the full funding of PCORI in 2014 is a development most observers haven't noticed when they discuss the big changes coming next year under the health law. But it's an important one, analysts say.

IRS Revises Form 720 to Provide for Payment of PCORI Fee

The Internal Revenue Service has posted revised instructions for Tax Form 720 with important information for plan sponsors regarding how to submit the PCORI fee.

Form 720 is the form that must be used by employers and issuers to report their annual fee liability under new Internal Revenue Code (Code) Sections 4975 and 4976, as added by the Affordable Care Act (ACA), which generally require issuers and employers to pay a per capita fee to help fund the Patient-Centered Outcomes Research Institute (PCORI) Trust Fund. The fee is required to be reported annually on the second-quarter Form 720 and paid by its due date of July 31.

The ACA established PCORI to conduct research to evaluate and compare the clinical effectiveness, risks and benefits of medical treatments, services, procedures, drugs or other items or strategies that treat, manage, diagnose or prevent illness or injury. The fee is imposed on issuers of health insurance policies for each policy year ending on or after October 1, 2012, and before October 1, 2019, and plan sponsors of applicable self-insured health plans for each plan year ending on or after October 1, 2012, and before October 1, 2019. The fee is two dollars (one dollar in the case of policy years ending before October 1, 2013) multiplied by “the average number of lives covered under the policy.” For policy years ending on or after October 1, 2014, the fee is increased based on increases in the projected per capita amount of National Health Expenditures.

PCORI Opportunity: Apply to Sit on an Advisory Panel

The Patient-Centered Outcomes Research Institute has announced a new opportunity for patients, caregivers, clinicians, researchers, other healthcare stakeholders, and the general public to help advance its scientific and engagement work - the establishment of the first four PCORI Advisory Panels. These panels will help to advance research efforts in the following areas:

• Assessment of Prevention, Diagnosis, and Treatment Options 
• Improving Healthcare Systems 
• Addressing Disparities 
• Patient Engagement 

The panels, which will have 12 to 21 members each, will assist PCORI staff, the Board of Governors, and the Methodology Committee in a number of ways, including helping to model full and meaningful patient and stakeholder engagement efforts and refine and prioritize specific research questions. They will also provide additional scientific or technical expertise as well as input on other questions that may arise relevant to PCORI's mission and work.

Further information on desired qualifications and time requirements can be found in the Frequently Asked Questions section of the PCORI website.  Applications can be submitted online until 5:00 p.m. ET, Monday, March 4.

Panelists will be selected based on experience, background, ability to contribute to the scope of work described in the panel charters, and commitment to advancing PCORI's mission. Additional PCORI Advisory Panels will be established over time, as and when needed. This is a good opportunity for employers, who are providing half of the funding for PCORI through a per-covered-life fee, to be involved in the work of the Institute and to ensure that the employer voice is represented.

New Funding Opportunity Announcement from PCORI

The online application system is now open for business for Cycle III funding for PCORI Funding Announcements (PFAs) issued under the first four of the five National Priorities for Research. There are three funding cycles each year for all of our PFAs.

These PFAs correspond to the following national priority areas:

• Assessment of Prevention, Diagnosis, and Treatment Options - for projects that address critical decisions that patients, their caregivers and clinicians face with too little information. 
• Improving Healthcare Systems - for projects that address critical decisions that face health care systems, the patients and caregivers who rely on them, and the clinicians who work within them. 
• Communication and Dissemination - for projects that address critical elements in the communication and dissemination process among patients, their caregivers and clinicians. 
• Addressing Disparities - for projects that will inform the choice of strategies to eliminate disparities. 

All of the PCORI funding announcements have been recently updated.  As discussed previously on NBCH member calls, PCORI funding at this stage still seems to be aimed primarily at more traditional researchers, but we are still exploring ways to ensure that the employer voice can be heard.

You can learn more about all future funding milestones and access application materials, including our revised Application Guidelines, in the PCORI Application Center.

For any questions please contact us at pfa@pcori.org.

Treasury Department Releases Final Regulation on PCORI Trust Fund

This final regulation implements and provides guidance on the fees imposed by the Affordable Care Act on issuers of certain health insurance policies and plan sponsors of certain self-insured health plans to fund the Patient-Centered Outcomes Research Trust Fund.

Section 6301 of the ACA amended the Internal Revenue Code by adding new section 9511 to establish the Patient-Centered Outcomes Research Trust Fund (the "Trust Fund"), which is the funding source for the Institute. Section 6301 of the ACA also added new Code sections 4375, 4376, and 4377 to provide a funding source for the Trust Fund that is to be financed, in part, by fees to be paid by issuers of specified health insurance policies and sponsors of applicable self-insured health plans.

Section 4375 imposes a fee on an issuer of a specified health insurance policy for each policy year ending on or after October 1, 2012, and before October 1, 2019. The fee is two dollars (one dollar in the case of policy years ending before October 1, 2013) multiplied by the average number of lives covered under the policy. For policy years ending on or after October 1, 2014, the fee is increased based on increases in the projected per capita amount of National Health Expenditures. The fee imposed by section 4375(a) shall be paid by the issuer of the policy, and the regulation defines a specified health insurance policy as any accident or health insurance policy (including a policy under a group health plan) issued with respect to individuals residing in the United States.

PCORI Patient Engagement Workshop Webcast Information

The Patient-Centered Outcomes Research Institute (PCORI) is providing a free webcast for the plenary sessions of its patient engagement workshop, "Transforming Patient-Centered Research: Building Partnerships and Promising Models," October 27-28. The workshop is designed to help PCORI build a patient-centered research community. Workshop participants will help PCORI establish procedures for identifying research questions, reviewing research proposals for funding, and ensuring patient participation throughout the research process. It is the first in a series of workshops aimed at bringing PCORI's vision for patient and stakeholder engagement to life.

Because in-person attendance at the workshop is limited and full, following an open application process, PCORI is providing three opportunities for all patients and healthcare community members to be a part of the process and provide input on the workshop's five topics: 

1. Identifying and Selecting Research Questions 
2. Reviewing Research Proposals for Funding 
3. Matching Patients and Stakeholders with Researchers 
4. Disseminating Research to the Community 
5. Evaluating PCORI's Patient and Stakeholder Engagement Programs 

To take part, you can:
Watch a live webcast of workshop plenary sessions:
Saturday, October 27, 8:30 a.m.-11:00 a.m. ET
Sunday, October 28, 8:00 a.m.-12:30 p.m. ET

Visit pcori.org to access the webcast, view the workshop agenda, read more about the workshop topics and get to know our presenters and facilitators. We look forward to your participation and feedback as we build a patient-centered research community.

PCORI Announces Second Cycle of Funding Opportunties

The Patient-Centered Outcomes Research Institute (PCORI) has announced a second funding cycle for four out of the five areas outlined in the National Priorities for Research and Research Agenda: communication and dissemination; improving health care systems; assessment of prevention, diagnosis, and treatment options; and addressing disparities. PCORI will release an additional funding announcement this fall for the fifth focus area: accelerating patient-centered and methodological research.

PCORI will fund up to $96 million in awards. PCORI anticipates funding approximately 54 contracts totaling up to $48 million for projects related to assessment of prevention, diagnosis, and treatment options; approximately 27 contracts totaling up to $24 million for projects related to improving health care systems; approximately 14 contracting totaling up to $12 million for projects related to communication and dissemination; and approximately 14 contracts totaling up to $12 million for projects related to addressing disparities. Direct projects costs may total up to $500,000 per year and project periods may be up to three years. Eligible applicants include IRS-recognized private sector research organizations (non-profit and for-profit) and public sector research organizations (universities, colleges, hospitals, laboratories, health care systems, and units of state and local governments). Foreign and non-domestic organization components may also be eligible and should consult PCORI’s application guidelines for more information.

Letters of intent are due October 15, 2012 and applications are due December 17, 2012. PCORI will hold informational webinars between October and November of 2012. More information about the funding opportunities is on the PCORI website.

PCORI Announces Pilot Projects Program Awards Recipients, Research Topics

The Patient-Centered Outcomes Research Institute (PCORI) has announced the approval of 50 research funding awards, totaling $30 million over two years, through its Pilot Projects Program, which will address a broad range of questions about methods for engaging patients in the health research and dissemination process.

“These projects will improve our understanding of how to conduct research and disseminate research findings in ways that are more responsive to the needs of patients and the health care community,” said PCORI Executive Director Joe Selby, MD, MPH. “We are excited to have approved funding for 50 projects nationwide, led by creative and innovative researchers. Their work will help us establish a foundation for patient-centered research that will give patients, caregivers and clinicians the information and tools they need every day.”

The Pilot Projects were selected by PCORI‘s Board of Governors through a competitive, multi-stage review process. Proposals were evaluated for their scientific merit and rigor and fit within the eight areas of interest outlined in the pilot projects announcement. All awards have been approved pending completion of a business review and a formal award agreement with PCORI.

“The impressive volume of high-quality funding applications we received persuaded us to expand the program beyond its original scope to ensure we are capturing as much valuable information as possible to support our patient-centered research efforts,” said PCORI Board of Governors member Christine Goertz, DC, PhD, who led the Pilot Projects Program effort. “The Pilot Projects will allow PCORI to learn more about evidence-based methods and strategies, with an emphasis on effectively involving patients in the entire research process, from the selection of research topics to the dissemination of results.”

Awards, approved for research institutions in 24 states and the District of Columbia, include those for projects designed to develop a range of tools and techniques aimed at improving patient-centered care and decision-making; create new patient-centered care measures; and improve delivery of patient-centered counseling and care in various health care settings.

PCORI Amends its Research Agenda

The board of the Patient-Centered Outcomes Research Institute has voted to amend PCORI's draft research agenda in response to 15 major themes that emerged from more than 450 public comments on its proposed agenda, released in February. NBCH was among the organizations providing comments. The board did not recommend any changes in the quasi-governmental agency's National Priorities for Research, saying the public comments did not identify significant gaps in the five proposed priorities. PCORI plans to incorporate the revisions and vote on the final agenda and national priorities next month. The board also approved $30 million in funding over two years for a slate of 50 pilot projects that will address a broad range of questions about methods for engaging patients in various aspects of the research and dissemination process. Once the research agenda is finalized, PCORI plans to distribute $120 million of research funding by the end of the year.  According to the statute that establishes PCORI, about half of its funding comes from $2-per-covered-life assessments on employers, both insured and self-insured.