PCORI approves $70M for patient-centered research

What is the most effective way to treat chronic migraines while preventing medication overuse? Would motivational text messages from a doctor’s office help diabetes patients better manage their conditions? What is the optimal dose of aspirin to prevent heart attacks and strokes? The answers to those questions may soon be available, thanks to the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors, which approved $70 million in awards for nine, patient-centered research projects for various conditions ranging from asthma to breast cancer.


PCORI is an independent, non-profit organization established by section 6301 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). It funds research to provide patients, caregivers, and clinicians with information to make better-informed health care decisions. PCORI has dedicated over $1.2 billion to research funding.

Pragmatic Clinical Studies

Five of the research projects were awarded funding as part of PCORI’s initiative to support pragmatic clinical studies (pragmatic studies), which are aimed at producing results that are relevant to a broader range of patients and care settings and that are easy to adopt. The studies are conducted in more routine clinical settings rather than in specialized research centers and use study participants that are similar to typical patients.

All of the pragmatic studies work with national advocacy organizations, professional associations, payers, and other key stakeholders to design and implement their studies so as to speed up the dissemination and application of the results.

Breast Cancer

One of the newly approved pragmatic studies will compare treatment options for individuals diagnosed with ductal carcinoma in situ (DCIS), which is an early stage, localized type of breast cancer. The study will examine whether women who undergo active surveillance have the same invasive cancer rate as those who undergo traditional treatments, such as surgery and radiation. It will also compare the mastectomy rate, survival endpoints, and quality of life endpoints between the two groups.

Chronic Migraines

Another study seeks to find an effective treatment for sufferers of chronic migraines who overuse their medication. The study will look at two methods of treatment, and determine whether an early discontinuation of overused medication combined with migraine prophylactic therapy is more effective than continuing the overused medication during the therapy.

“We’re strongly committed to supporting large-scale projects that will provide patients and those who care for them with the useful, authoritative evidence they need to make the better-informed health and health care decisions,” said PCORI Executive Director Joe Selby, MD, MPH.

Clinical Data Research Networks

PCORI also awarded $6.7 million to three Clinical Data Research Networks (CDRNs) that are members of PCORnet, which is the organization’s initiative to establish a national, patient-centered clinical research network. The award will help the CDRNs study how population-targeted health policies and interventions impact complications, risks, and disparities relating to type II diabetes. The projects will be part of the new, Natural Experiments Network (NEN), which is collaboration between PCORI, the Centers for Disease Control and Prevention, and the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The research projects are aimed at assisting policy makers and community leaders prioritize policies so as to prevent diabetes.

Additional Studies

The PCORI Board also approved $5.2 million in funding for a study that will examine whether motivational text messages or diabetes wellness coaches more effectively assist African-American patients in managing uncontrolled diabetes.

A study that seeks to identify the optimal dose of aspirin to prevent heart attacks and strokes in heart disease patients also received $3.8 million. The award will fund expanded trial activities and will recruit patients who have no Internet access. It is estimated that finding optimal aspirin doses could save thousands of lives.

PCORI notes that all of the awards were approved pending review by its staff and the issuance of formal award contracts.

Dual eligible demonstrations huge undertaking, but may show promise

Coordinating care for beneficiaries who are eligible for both Medicare and Medicaid (dual eligibles) can be challenging and demand a significant amount of state resources. Reports released by CMS that evaluated the implementation of its Financial Alignment Initiative demonstrations in various states and in Washington’s health home managed fee-for-service model revealed the unexpected challenges states faced in attempting to improve care coordination across the two complex and distinct health care programs. However, the reports also indicate that Washington’s demonstration shows initial promise in significantly reducing Medicare costs.

Multi-state Demonstrations

CMS contracted with RTI International to review the first six months of implementation of dual eligible demonstrations in California, Illinois, Massachusetts, Minnesota, Ohio, Virginia, and Washington. The demonstrations arose from CMS’ Financial Alignment Initiative, which was created to test integrated care and financing models for dual eligibles. The goals of the demonstrations were to develop person-centered care delivery models that would integrate medical, behavioral health, and long-term services and supports (LTSS) for dual eligibles and address the current challenges associated with care coordination between Medicare and Medicaid.

The review examined integrated delivery systems, enrollment, care coordination models, beneficiary safeguards, and stakeholder involvement in each of the demonstrations. Although the models and features of the demonstrations varied across the states, the review found notable similarities.

For states that adopted the capitated model, three-way contracts have been negotiated between CMS, states, and Medicare-Medicaid plans (MMPs) that create delivery models, provider networks, access and quality standards, beneficiary protections, requirements for data submissions, and payment arrangements. In order to implement the demonstrations, state officials had to entirely redesign eligibility, enrollment, and data systems so that they could effectively interface with Medicare.


The review found that fewer beneficiaries enrolled during the first six months than were previously anticipated, which may have been caused by the difficulties states experienced in locating beneficiaries and persuading them of the benefits of the service model.

Other findings

States also made significant investments in training care coordinators, providers, and MMPs about dual eligibles’ special needs. States used CMS funds to establish or enhance assistance and ombuds programs to support beneficiaries so as to facilitate informed and impartial decision making and to resolve problems. Stakeholders were found to be actively engaged in ensuring the transparency of the demonstration and to be responsive to beneficiary needs.

Resource commitments

States found that the upfront time and resource commitment that was needed to implement the demonstrations “far exceeded” their estimates, with officials reporting that they were unaware of many of the Medicare requirements. As a result, reconciling the differences between Medicare and Medicaid operations took up a significant amount of resources. At the time of publication, it is unclear whether the resource commitments will lessen as the demonstrations progress.

Washington Model

RTI also reviewed the first six quarters of Washington’s managed fee-for-service model, which uses Medicaid health homes, which were established under Section 2703 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) in an attempt to integrate care for high-cost, high-risk full-benefit Medicare-Medicaid beneficiaries. Medicaid health homes are the lead local entities in the demonstration that are responsible for care coordination and bridge care across the health care delivery systems.

Care coordinators

Beneficiaries are assigned a health home coordinator who will assist in coordinating their services. A coordinator works with beneficiaries to develop Health Action Plans (HAPs) and has access to information about the enrollee’s utilization of Medicare and Medicaid-financed services through the Predictive Risk Intelligence System (PRISM). The HAP will be used to prioritize health action goals and will set forth action needed to accomplish those goals and identify where intervention and supports are needed.


The state hired a sufficient number of health care coordinators so that it was able to offer the health home demonstration to beneficiaries in all of its 37 counties. Enrollment in the demonstration increased every quarter, with over 50 percent of eligible beneficiaries enrolled by the end of 2014.

Cost impact

Initial findings suggest that the demonstration has been successful in reducing costs. The review found substantial reductions in monthly, per-member Medicare costs that exceeded the largest monthly payments that were made for health home services. The report notes that further adjustments will be required to account for changes in Medicaid costs, but that the health home intervention has successfully lowered costs.

Quality of care

It is not yet known whether the quality of care was able to be maintained or improved while the cost savings were achieved by the Washington demonstration. However, none of the findings suggest that the demonstration is having a detrimental effect on beneficiaries or on costs. While further research will provide more information about the demonstration’s impact on utilization and quality of care, Medicare Utilization Data did show some decreases or leveling off of rates of inpatient hospitalization admissions in general and physician office visits. Other measures showed either no trend change during the demonstration period. The report notes, however, that the trends could be attributable to the fact that new demonstration entrants may have fewer health care and LTSS needs than earlier program entrants.

Continued Evaluation

RTI will continue to monitor and evaluate all of the demonstrations by collecting information on a quarterly basis and producing annual reports for each demonstration performance years, which will be posted on CMS’ website. RTI will also examine the experiences of beneficiaries, their families, and caregivers to determine whether the demonstrations meet their goals of developing person-centered delivery models. Additionally, a quantitative evaluation of quality of care, utilization, access to care, and cost will also be conducted as soon as the data is available.

Centene loses hard drives containing health information of 950,000 individuals

Health insurance company Centene Corporation (Centene) is looking for six misplaced computer hard drives that contain the personal health information of an estimated 950,000 individuals. While the lost hard drives do not include any financial or payment information, the company says that names, addresses, birthdates, social security numbers, and health information of individuals who received laboratory services from 2009 to 2015 are contained within the drives.

Internal search

Centene Chairman, President and CEO, Michael F. Neidorff, says that the company does not believe that the information was used inappropriately, but adds that it is disclosing its ongoing search for the drives, “out of abundance of caution and in transparency.” The drives were part of a data project that intended to use laboratory results to improve health outcomes.

The company is reviewing and “reinforcing” its information technology (IT) asset managing procedures and is offering free credit and health care monitoring for the individuals who are affected by the loss.


The HHS Office for Civil Rights (OCR) website does not currently reflect that Centene has reported the missing drives to that agency. The Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191) Omnibus Final Rule (78 FR 5566) requires HIPAA covered entities and business associates to notify patients of breaches unless they actually demonstrate a low probability that protected health information was compromised (45 C.F.R. sec. 164.404). For breaches involving 500 individuals or more, CEs must notify HHS at the same time that they make individual notifications; in addition, they must notify the media (45 C.F.R. sec. 164.408).

Recent breaches

In 2015, there were six breaches that affected more than a million individuals that were reported on the HHS OCR’s website. These included breaches at Anthem, which compromised the data of 78.8 million individuals, and Premera Blue Cross, which reportedly involved 11 million records. Both breaches were tied to Chinese espionage (See 5 hot topics in cybersecurity, Health Law Daily, January 7, 2016).

Health programs

Centene provides programs and services to government-sponsored health care programs, including Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP).

AMA becomes partner in Silicon Valley health care innovation company

The American Medical Association (AMA) is spending $15 million to become a founding partner of Health2047, a health care innovation company that is aimed at transforming U.S. health care within the next 30 years. Health2047 will be a standalone, for-profit company that will work with companies, physicians, and entrepreneurs to improve health care and to bridge the gap between physicians and Silicon Valley.


Health2047’s stated goals include using collaboration to create a health care system that achieves better individual health outcomes, greater physician job satisfaction, streamlined administrative operations, and partners who are rewarded for their financial investments.

Chief Executive of the AMA, James L. Madara, M.D., noted that cumbersome technology, such as electronic health records that are difficult to use and lack interoperability, often creates professional dissatisfaction by taking time away from patient interaction and is a major contributor to physician burnout. Therefore, the AMA intends to use new technology to support patient care rather than hindering it.

Innovation studio

Health2047’s Innovation Studio will be based in Silicon Valley and will develop new products and resources to improve the practice of medicine and health care delivery. Doug Given, MD, PhD, Chief Executive of Health2047 said that Silicon Valley was chosen for its high density of talent, strong venture funding environment, and because it is home to several prominent health research institutions.

Health2047 plans on collaborating with AMA content experts from various fields, including the medical, health policy, and “pragmatic practice” areas to co-develop “offerings” that will have a big impact on medical practices and the health care field.


The company intends to incorporate physician input during all stages of its projects. It will use physician testing and user feedback during development of prototypes, and it will use its access to physicians as a way to accelerate the adoption of health care solutions.

Its projects will be subject to a timeline, during which the first 30 days will be used to determine whether a project has the potential to be transformative. After 30 days, Health2047 will either invest another 60 days in the project or archive it and move on to another one. The company says that the time constraints are necessary to force teams to rapidly develop a deep understanding of the value of projects and about what aspects need to be addressed further.

Health2047 concedes that its goals seem “very conceptual” at the present, but points out that it intends to find solutions that make concrete improvements for physicians’ practices and patients in the near future.

Madara said, “Health2047’s product orientation and entrepreneurial DNA will help forge new paths and bring commercial solutions to market faster.”

Other partnerships

The investment in Health2047 is not AMA’s first foray into innovation partnerships. It previously partnered with MATTER, a health care technology incubator that is based in Chicago, which allows physicians and other industry experts to collaborate and create technologies to improve health care. MATTER is planning on launching a curriculum of 10 tracks to address the most common health care startup pitfalls.

MATTER’s Interaction Studio will be designed to simulate a health care environment by using physical and “virtual infrastructure.” Users will be able to use advanced video and audio technologies to better understand workflow and how new products and services can be used in the future health care delivery environment. Entrepreneurs will also have access to physicians through the AMA, so that they can gain input on their ideas. The partnership with MATTER will also involve educational workshops, interactive simulations, and collaboration events that are focused on optimizing physician-patient interactions.