June Health Policy Update


Patient Engagement: The CHRONIC Care Act, CMMI, and the Future

Tony Coelho
Former Congressman and Chairman
Partnership to Improve Patient Care

“Nothing about us without us.”

This mantra – popularized by disability rights groups in the early 1980s, and adopted since by patient advocates across the spectrum – manifests a call for patient engagement in all facets of healthcare policymaking.

I, along with many other advocates, have expressed concern in recent months as we’ve witnessed Congress propose wide-ranging reforms to the healthcare system with little input from the people the system is intended to serve. Regardless of the future of the Affordable Care Act, however, the shift towards “value” in driving healthcare decisions will continue unabated. Patients must be at the center of value-based decisions, or they will again be left at the margins.

I will not shy from voicing concern when I think policymakers (Republican or Democrat) are leaving out the patient – but I will also give credit where it is due. While a tremendous amount of work remains to be done, policymakers took two steps recently that show progress is possible. One was approval by the Senate Finance Committee of the CHRONIC Care Act, a bipartisan bill (yes, they still exist!) whose success is attributable to significant stakeholder engagement and that, if enacted, will help to meet real patient needs.

We’ve also cheered regulators’ increasing responsiveness to the needs of patients. For example, the Department of Health and Human Services (HHS) recently signaled a small but important step in the right direction when they announced the creation of a patient ombudsman to help promote patient perspectives in Medicare’s shift towards alternative payment models (APMs). The new Alternative Payment Models Beneficiary Ombudsman will play an essential role in helping Medicare beneficiaries understand and navigate new “value-based” payment models developed through the Center for Medicare and Medicaid Innovation (CMMI).

While each of these respective developments are important – and should be applauded by the patient community – they represent only pieces of the systematic reforms that should be advanced to ensure that the definition of “value” in Medicare prioritizes providing “value” to the patient. This principle is particularly important as policymakers move quickly to develop policies that are fundamentally changing how “value” is defined.

With that in mind, there are several concrete steps policymakers could take to ensure that the patient remains at the center of value-based care. For example, Congress or the new leadership at HHS should act to create an infrastructure for patient engagement within CMMI to help ensure new payment models are aligned with care that patients value. Patients could provide guidance to the Innovation Center in identifying key areas that would benefit from patient input, including APM development, model design features that will promote effective patient engagement, and metrics by which to assess the success of these efforts.

Further, to maintain accountability, CMMI should note where they have incorporated stakeholder feedback when finalizing demonstration programs, and be required to provide a rationale for instances in which stakeholder feedback has not been incorporated. Also, rulemaking and public comment opportunities should include information about how a proposal is incentivizing high-quality patient-centered care. This will help to give patients and other stakeholders an opportunity to shape CMMI’s work. Generally speaking, the agency could also benefit from greater patient input as part of its quality measures plan and the development of measures that focus on health outcomes that matter to patients with chronic disease.

Our diseases, conditions, and disabilities may differ. We each may have distinct treatment preferences, risk profiles, genetic predispositions, and priorities for recovery. Yet we share the goal of getting care that is tailored to our individual characteristics, needs, and preferred outcomes.

Regardless of what happens in Washington, health care will continue shifting to pay for care based on value. But will it pay for care that we, as patients and people with disabilities, value? Only if we make our voices heard.

Open Advocacy Opportunities

  • To read about the establishment of the FDA Office of Patient Affairs and submit comments on the docket, click here.
  • To nominate a qualified candidate to participate in the FDA Patient Representative Program, click here.
  • To learn about the FDA CDRH Advocacy Committee and nominate a qualified candidate, click here.


European Liver Patients’ Association (ELPA)

ELPA, in collaboration with the World Hepatitis Alliance and The Israeli Organization for Liver Health, released a documentary film titled Hep C - From Hell to Hope. The film chronicles the lives of patients suffering from hepatitis C, the global difficulties in hepatitis C treatment, and the policies both in place and still needed to help those affected by the disease. To watch the film, click here.

World Health Organization (WHO)

As part of “Ten years in public health 2007-2017”, WHO published an online report titled “Viral hepatitis: a hidden killer gains visibility.” The publication includes information on viral hepatitis, clinical management, vaccines, challenges faced, strategies for elimination, treatment guidelines, and additional resources. Read the publication here.

Canadian Liver Foundation (CLF)

CLF published a press release explaining the adverse consequences of new, more limited screening guidelines for hepatitis C in Canada. The article states that the screening guidelines, which recommend not testing adults unless they have identifiable risk factors, will lead to avoidable deaths and massive health care costs. Citing CDC data and recommendations, CLF issued its own recommendations that the screening guidelines include a widened bracket of ages for adult testing. This would allow for a 77% diagnosis rate, cutting down the major medical issues patients face as a result of living with undiagnosed hepatitis C. To read the full press release, click here.


Food and Drug Administration (FDA)

In late April, the FDA expanded the approved use of Stivarga to treat liver cancer patients who had been previously treated with the medication sorafenib. This is an important development in liver cancer treatment as Stivarga is the first new FDA-approved liver cancer treatment in over a decade. To read the press announcement and learn more about Stivarga and its clinical trials, click here.

U.S. Department of Health and Human Services (HHS)

The National Viral Hepatitis Action Plan 2017-2020 outlines actions to fight viral hepatitis in the United States. There are four main goals that HHS hopes to achieve by 2020: prevent new infection, decrease death rates while improving the health of those who suffer from viral hepatitis, reduce disparities in viral hepatitis health, and to focus on the implementation of viral hepatitis activities. To read the plan and its visions, goals, strategies, and indicators, click here.

Centers for Disease Control and Prevention (CDC)

CDC issued a press release titled “New Hepatitis C Infections Nearly Tripled over Five Years.” Recent surveillance reports state that the number of new hepatitis C infections have hit a 15-year high, and that more than half of the people with the disease are living undiagnosed. The press release states the extreme need for new policies and guidelines for screening, treatment, and prevention. To read the full press release, click here.


Patient-Centered Outcomes Research Institute (PCORI)

PCORI recently released several updated standards for guiding methods used in patient-centered outcomes research (PCOR). The newest version of the PCORI Methodology Standards includes updates on data analysis, data inclusion, and data network and selection procedures. The PCORI Methodology Standards is a resource outlining the minimum requirements for valid PCOR research. To learn more about the PCORI Methodology Standards and to read the updates, click here.


Pipeline to Proposal Awards Tier A Pre-Engagement/Community Projects. Funds available from PCORI: $50,000. Application deadline: June 30, 2017.

HIV and Hepatitis B Co-Infection: Advancing HBV Functional Cure through Clinical Research. Funds available from NIH: $200,000. Application deadline: May 7, 2020.

Mechanisms of Disparities in Chronic Liver Diseases and Cancer. Funds available from NIH: $200,000. Application deadlines: May 22, 2017, April 4, 2018, or April 4, 2019.



Senate Working Group on Healthcare Reform:

  • Majority Leader Mitch McConnell of Kentucky
  • Sen. John Cornyn of Texas
  • Sen. John Thune of South Dakota
  • Sen. John Barrasso of Wyoming
  • Chairman Lamar Alexander of Tennessee
  • Budget Chairman Mike Enzi of Wyoming
  • Finance Chairman Orrin Hatch of Utah
  • Sen. Ted Cruz of Texas
  • Sen. Mike Lee of Utah
  • Sen. Tom Cotton of Arkansas
  • Sen. Cory Gardner of Colorado
  • Sen. Rob Portman of Ohio
  • Sen. Pat Toomey of Pennsylvania