Senate HELP Committee Chairman Once Again Calls for Stage 3 Delay in Latest Hearing

Sept. 16, 2015
During a Sept. 16 Senate hearing on improving care through patient access to their records, Senate HELP Chair Lamar Alexander once again made his thoughts clear about the need for a Stage 3 delay.

During a Sept. 16  Senate meeting, healthcare leaders stressed the need for better electronic health record (EHR) usability, more patient access to data, and greater interoperability. Meanwhile, during the same meeting, Sen. Lamar Alexander (R-TN), Chairman of the Senate Health Education Labor and Pensions (HELP) Committee, once again pushed for a delay of Stage 3 of the meaningful use program.

The meeting was led by Sen. Susan Collins (R-ME) and Sen. Elizabeth Warren (R-MA), who both opened with statements that expressed their desires for a more interoperable, patient-centered healthcare system. “There remains a great deal of frustration for healthcare professionals in hospitals and clinics, and most of all for patients,” Collins said, speaking to the lack of data access and data sharing. “We are seeking advice on how to improve patient access for own health records. We want insights to the challenges. The fundamental question is, how can EHRs be improved to better serve patients?”

Sen. Warren mentioned that while the Health Insurance Portability and Accountability Act (HIPAA) has set important privacy standards and made it clear that patients have a right to see their information and share it with providers, there is still a ways to go before we achieve an interoperable, consumer-friendly healthcare system. “Most medical records are digital, but there is still a huge problem—systems don’t talk to each other well,” Warren said. This lack of interoperability imposes other costs such as wasted medical tests, time and money, she noted.

Key to Wednesday’s hearing were three witness testimonies from healthcare leaders in different segments of the industry— Raj Ratwani, Ph.D., scientific director at the National Center for Human Factors in Healthcare at the Washington D.C.-based MedStar Health, and assistant professor of emergency medicine, Georgetown University School of Medicine; Kathy Giusti, founder and executive chairman, Multiple Myeloma Research Foundation (MMRF); and Eric Dishman, Intel fellow, and general manager for health and life sciences, Intel Corporation.

Ratwani, known for his research on health IT vendors’ insufficient attention to EHR usability, spoke about just that, noting that “The usability of EHRs, patient portals and personal health records remains subpar and is a significant challenge that we must overcome immediately.” Downplaying the idea that the low utilization of patient portals comes from lack of interest, Ratwani said that in most cases, portals have not been designed using methods to optimize the system’s responsiveness to patient needs. “There is overwhelming evidence that usability of health IT systems impacts patient safety, and is crucial to adoption and effective use. There is a common misunderstanding that usability is only about basic screen design such as font size, color, and layout, but a better understanding is that usability needs to support the needs of clinicians of patients,” he said.

Ratwani noted that other high-risk industries, such as aviation, defense and nuclear energy, have taken this “human factors” approach, but healthcare has been slow to do so. “Patients and clinicians are able to comprehend, reason, and gain insight from health information only when the systems work in concert with the way patients and clinicians think,” he said, adding that the three human factors which have a tremendous impact on patient use of health IT are access, functionality and information quality. “To make advancements, we must refocus certification requirements to promote true usability in the design, development and implementation of health IT, with an understanding of industry constraints; increase transparency around usability; and spur competition in the marketplace by making it easier for new vendors to develop products,” he said.

Giusti’s and Dishman’s witness testimonies included personal stories, as both have overcome near-death diseases in remarkable, persistent fashion. Giusti, now founder of the Multiple Myeloma Research Foundation, was diagnosed with the disease at age 37 at which point doctors told her it was 100 percent fatal. Working with academia, government, industry, and technology partners, the MMRF created and end-to-end system in precision medicine, Giusti said. “We built our own data bank to capture the genetic changes in myeloma patients and their responses to treatment. We made this data publically available to all scientists. We built a clinical network that has conducted 60 trials of 30 compounds,” she said. “We educate our patients so they enroll in the right trial for them. Our community has seen seven new drugs win FDA approval, with three more expected in the next year. Our patients have benefited, nearly tripling survival from the three years when I was diagnosed to nine years today.”

Giusti said with that in mind, she would discuss health IT in three ways: engaging patients, utilizing data, and accelerating cures. Eighty-five percent of patients participating in her MMRF research knew they had a portal, and 95 percent of those patients used it, she said. Regarding data integration, Giusti said she has EHRs in six different locations scattered at various centers across the country. “I have no central repository where I can aggregate, access, and store information, and make it available to my healthcare team and to researchers. The greatest efficiency will come from our ability to integrate EHRs across the vast number of specialized doctors and centers that patients now see,” she said. “This is the world of precision medicine, this is where we all need to go,” she continued. The ability to understand, integrate, and aggregate EHRs is sitting on the critical path to research. We can make things happen so much faster and more efficiently. Now it’s time to do this across all diseases. We owe this to the patients we serve.”

Meanwhile, Intel’s Dishman, a 23-year cancer survivor, and member of the President Obama’s Precision Medicine Initiative Working Group, additionally testified about patient access to data and full interoperability. “Each of us needs to work with our care teams to build care plans, with goals and accurate tracking. Each of us needs to own our health—but the healthcare systems needs to do a much better job of giving us the tools, data, and responsibility to do so,” he said.

Five years into his cancer journey, Dishman said specialists on his care team screwed up treatments that put his heart at serious risk. And when the first clinical trial ever for the particular kidney cancer they thought he had at the time came out, Dishman was not able to pull all of his data together to be eligible for the trial. More recently, Dishman was running out of options for his full kidney failure when he met a genomic startup that offered to sequence his DNA. “After half a year of shipping hard drives of data across the country between oncologists, computer scientists, and data experts, my medical team came back with a plan based on my molecular makeup,” he said. “Within months, I was miraculously cancer-free and suddenly on the path to a kidney transplant that saved my life because, for the first time in 23 years, my oncologists had real and detailed data about me as an individual to act upon.”

Dishman added that he sees four main barriers that keep patients from accessing the data that they have a right to: organizations hiding behind HIPAA; clinicians lacking the tools to do so; skeptical attitudes that patients don’t have the ability to use their own data safely; and providers, vendors, and researchers hoarding patient data to monetize it for themselves.

MU Musings

After the testimonies, several senators on the committee offered comments and asked questions to the three witnesses. Included in this was Sen. Lamar Alexander, who has been outspoken previously on the need for greater interoperability, and how information blocking is standing in the way of it. In June, Alexander led the committee’s first hearing on the meaningful use program and EHR adoption, during which he said, “To put it bluntly, physicians and doctors have said to me that they are literally "terrified" on the next implementation stage of electronic health records, called meaningful use Stage 3, because of its complexity and because of the fines that will be levied.”

Sen. Lamar Alexander

In Wednesday’s hearing, he essentially repeated those thoughts. “We should delay the making of the final rule for Stage 3 until January 1, 2017. Then, the Stage 3 requirements should be phased in at a rate that reflects how successfully the program is being implemented,” he said. “The modified rules for Stage 2 should be adopted immediately, as those will help doctors and hospitals comply with government requirements. Patients need this interoperable system, but the government, physicians, and hospitals need time to do it right. Some hospitals have told me they are terrified by the prospect of Stage 3.  It does not help patients to makes these massive changes fast and wrong.  It does help patients to do this deliberately and correctly so that hospitals and doctors embrace the changes instead of dread them,” Alexander said.

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) sent the final rules for both meaningful use Stage 3 and Stage 2 modifications to the Office of Management and Budget (OMB) for review. Despite Alexander’s and others’ push for a delay, indications are that the final rules will be signed by OMB and published in early fall.

Interestingly, Intel’s Dishman disagreed with the idea of a Stage 3 delay. “I know there is pressure from folks who want a delay. But I say, don’t delay, this is a hard transformation. We are not done with meaningful use. We might call it something else later on, but we’re still going. We need to get out and establish standards and common data models for these new types of data,” he said. “We need to be ready to understand that the complete medical record is not just what’s in the traditional EHR. Let’s keep driving towards that innovation model. It will take four to five more years to get there.” 

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