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Final 21st Century Cures Act Scheduled for House Vote This Week

November 28, 2016
by Heather Landi
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The U.S. House of Representatives is scheduled to vote Wednesday on the 21st Century Cures Act, a $6.3 billion package of medical innovation bills that now includes $4.8 billion to the National Institutes of Health as well as $1 billion in state grants to fight opioid abuse.

House and Senate health committee leaders released a final version of the legislation over the holiday weekend, on Friday, Nov. 25th. A section-by-section summary of the bill can be found here.

As previously reported by Healthcare Informatics, there had been concerns that the legislation would not pass during the lame duck session of Congress as Democrats on the House Energy and Commerce Committee wanted the bill to include policies to address high drug prices. Additionally, finding a way to pay for new mandatory funding for medical research at NIH has been an obstacle as well.

Healthcare stakeholders have touted the health IT provisions of the bill, particularly regarding the Food and Drug Administration’s oversight of the sector, as well as encouraging interoperability of electronic health records (EHRs) and patient access to health data, and discouraging information blocking.  

In a statement, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Chairman Lamar Alexander (R-TN) said,It is time to vote on 21st Century Cures, mental health legislation, and help fund the fight against opioid abuse. The House vote on Wednesday will be an extraordinary opportunity to help almost every American family. It will advance President Obama’s personalized medicine initiative, Vice-President Biden’s cancer moonshot, Alzheimer’s research and move many treatments and cures more rapidly and safely through the regulatory process and into doctors’ offices. It will address the needs of the one in five adult Americans who suffer mental illness.”

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“What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day. And it is critical to remember that passing 21st Century Cures is the best way to ensure some of this funding occurs immediately in Fiscal 2017,” Upton and Alexander said in the statement.

Senate Majority leader Mitch McConnell has described the Cures bill as "the most important legislation Congress will consider this year” and said that, after the House acts, the Senate will act before the end of December.   

Matthew Weinstock, spokesperson for the College of Healthcare Information Management Executives (CHIME), said in a statement that while CHIME members are still reviewing the bill, he praised “improvements in language surrounding transparency, security, interoperability and usability of certified health IT.” Additionally, he stated, “We are encouraged by language that would instruct HHS [U.S. Department of Health and Human Services] to examine, and, hopefully reduce, the reporting burden on providers.”

Earlier this year, CHIME launched its $1 million National Patient ID Challenge and Weinstock also noted the language in the bill specifically requiring the Government Accountability Office (GAO) to conduct a study, within one year of the bill’s passage, on methods for securely matching patient records to the correct patient.

“We are pleased to see that the bill retained language instructing GAO to investigate and report on patient matching. We’d prefer a shorter timeframe for GAO to come back to Congress, but believe that this represents a growing recognition that we must address the serious issues of patient identification and patient matching,” he said. “While patient ID and patient matching are slightly different topics, we are very encouraged that lawmakers and policymakers are paying attention and looking for solutions.”

Here is a breakdown of the health IT-related provisions of the 21st Century Cures Act:

Innovation Projects and State Responses to Opioid Abuse

The legislation will provide $4.8 billion to NIH, including: $1.4 billion for President Obama’s Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease; $1.8 billion for Vice President Biden’s "Cancer Moonshot” to speed research; and $1.6 billion for the BRAIN initiative to improve research into diseases like Alzheimer's and speed diagnosis and treatment.

The legislation also included $500 million to the Food and Drug Administration (FDA) over 10 years with the aim of moving drugs and medical devices to patients more quickly. And the bill provides $1 billion over two years for grants to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs (PDMPs).

EHR Requirements and Interoperability

In a section titled “Delivery,” the bill has many health IT-related provisions, including instructing the Secretary of HHS to work with healthcare providers, payers and vendors to reduce regulatory and administrative burdens relating to the use of electronic health records. The bill instructs HHS to develop a strategy for meeting this goal within one year of the legislation’s passage.

The bill also authorizes $15 million for ONC’s certification process to improve interoperability and fight information blocking. The legislation would establish a grant program to create an unbiased reporting system to engage stakeholders and gather information about EHR usability, interoperability, and security to help providers better choose EHR products.

The legislation defines interoperability as “health information technology that enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user and allows for complete access, exchange, and use of all electronically accessible health information for authorized users,” and “does not constitute information blocking.”

With regard to certification for EHR developers, under the bill, developers will be required to attest that they will use open application programming interfaces (APIs), have successfully tested the real-world use of the technology for interoperability and will not take any action that is constituted as information blocking or restricts communication.

And, the bill calls for ONC, working with the National Institute for Standards and Technology (NIST), to develop a voluntary model framework and common agreement for the secure exchange of health information. Within six months of the bill’s passage, ONC must work with public and private stakeholders to develop or support a trusted exchange framework for exchange between health information networks. And, the bill calls for ONC, within a year, to publish the trusted exchange framework and common agreement, and ONC also is instructed to publish the names of networks that use the trust framework.

Within two years of the bill’s passage, ONC must create a digital health care provider directory to facilitate exchange.

Additionally, under the legislation ONC would be allowed to create a voluntary EHR certification program for medical specialties for which no certified technology exists, such as pediatrics. And, the bill’s provisions would exclude ambulatory surgical centers from meaningful use penalties for three years or until ONC creates an EHR certification program for them.

HIT Advisory Committee – Under the 21st Century Cures bill, the separate HIT Policy and Standards Advisory Committees within ONC would be consolidated into one HIT Advisory Committee to specifically address issues related to interoperability, privacy, and security.

Information Blocking – The bill defines information blocking as “a practice that is likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information.” And, the bill authors provided examples, such as “practices that restrict authorized access, exchange or use of such information for treatment and other permitted purposes such as transitions between certified health information technologies,” and “implementing health information technology in nonstandard ways that are likely to increase the complexity or burden of accessing, exchanging or using electronic health information.”

The bill would establish authority for the HHS Office of the Inspector General to investigate claims of information blocking and assign penalties for practices found to be interfering with the lawful sharing of EHRs. Organizations that are found to have committed information blocking face civil monetary penalties up to $1 million.

Leveraging EHRs to improve patient care – The bill encourages the exchange of health information between registries and electronic health record systems. Additionally, the bill adds developers of health information technology to patient safety organizations to help improve the safety of HIT products for patients.

 

Medical Devices and Software

According to a press release about the bill, provisions in the bill will help bring drugs and devices to market more quickly and at less cost by making needed reforms to the FDA, including: expedited review for breakthrough devices, increased patient involvement in the drug approval process, a streamlined review process for combination products that are both a drug and device, and freedom from red tape for software like Fitbit or calorie counting apps. The bill clarifies that technology software such as EHRs and clinical decision support tools are exempted from FDA regulation.

 


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Allscripts Sells its Netsmart Stake to GI Partners, TA Associates

December 10, 2018
by Rajiv Leventhal, Managing Editor
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Just a few months after Allscripts said it would be selling its majority stake in Netsmart, the health IT company announced today that private equity firm GI Partners, along with TA Associates, will be acquiring the stake held in Netsmart.

In 2016 Allscripts acquired Kansas City-based Netsmart for $950 million in a joint venture with middle-market private equity firm GI Partners, with Allscripts controlling 51 percent of the company. With that deal, Allscripts contributed its homecare business to Netsmart, in exchange for the largest ownership stake in the company which has now become the largest technology company exclusively dedicated to behavioral health, human services and post-acute care, officials have noted.

Now, this transaction represents an additional investment for GI Partners over its initial stake acquired in April 2016, and results in majority ownership of Netsmart by GI Partners.

According to reports, it is expected that this sale transaction will yield Allscripts net after-tax proceeds of approximately $525 million or approximately $3 per fully diluted share.

Founded 50 years ago, Netsmart is a provider of software and technology solutions designed especially for the health and human services and post-acute sectors, enabling mission-critical clinical and business processes including electronic health records (EHRs), population health, billing, analytics and health information exchange, its officials say.

According to the company’s executives, “Since GI Partners' investment in 2016, Netsmart has experienced considerable growth through product innovation and multiple strategic acquisitions. During this time, Netsmart launched myUnity, [a] multi-tenant SaaS platform serving the entire post-acute care continuum, and successfully completed strategic acquisitions in human services and post-acute care technology. Over the same period, Netsmart has added 150,000 users and over 5,000 organizations to its platform.”

On the 2018 Healthcare Informatics 100, a list of the top 100 health IT vendors in the U.S. by revenue, Allscripts ranked 10th with a self-reported health IT revenue of $1.8 billion. Netsmart, meanwhile, ranked 44th with a self-reported revenue of $319 million.

According to reports, Allscripts plans to use the net after-tax proceeds to repay long-term debt, invest in other growing areas of its business, and to opportunistically repurchase its outstanding common stock.

The transaction is expected to be completed this month.

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Study Links Stress from Using EHRs to Physician Burnout

December 7, 2018
by Heather Landi, Associate Editor
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More than a third of primary care physicians reported all three measures of EHR-related stress
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Physician burnout continues to be a significant issue in the healthcare and healthcare IT industries, and at the same time, electronic health records (EHRs) are consistently cited as a top burnout factor for physicians.

A commonly referenced study published in the Annals of Internal Medicine in 2016 found that for every hour physicians provide direct clinical face time to patients, nearly two additional hours are spent on EHR and desk work within the clinic day.

Findings from a new study published this week in the Journal of the American Medical Informatics Association indicates that stress from using EHRs is associated with burnout, particularly for primary care doctors, such as pediatricians, family medicine physicians and general internists.

Common causes of EHR-related stress include too little time for documentation, time spent at home managing records and EHR user interfaces that are not intuitive to the physicians who use them, according to the study, based on responses from 4,200 practicing physicians.

“You don't want your doctor to be burned out or frustrated by the technology that stands between you and them,” Rebekah Gardner, M.D., an associate professor of medicine at Brown University's Warren Alpert Medical School, and lead author of the study, said in a statement. “In this paper, we show that EHR stress is associated with burnout, even after controlling for a lot of different demographic and practice characteristics. Quantitatively, physicians who have identified these stressors are more likely to be burned out than physicians who haven't."

The Rhode Island Department of Health surveys practicing physicians in Rhode Island every two years about how they use health information technology, as part of a legislative mandate to publicly report health care quality data. In 2017, the research team included questions about health information technology-related stress and specifically EHR-related stress.

Of the almost 4,200 practicing physicians in the state, 43 percent responded, and the respondents were representative of the overall population. Almost all of the doctors used EHRs (91 percent) and of these, 70 percent reported at least one measure of EHR-related stress.

Measures included agreeing that EHRs add to the frustration of their day, spending moderate to excessive amounts of time on EHRs while they were at home and reporting insufficient time for documentation while at work.

Many prior studies have looked into the factors that contribute to burnout in health care, Gardner said. Besides health information technology, these factors include chaotic work environments, productivity pressures, lack of autonomy and a misalignment between the doctors' values and the values they perceive the leaders of their organizations hold.

Prior research has shown that patients of burned-out physicians experience more errors and unnecessary tests, said Gardner, who also is a senior medical scientist at Healthcentric Advisors.

In this latest study, researchers found that doctors with insufficient time for documentation while at work had 2.8 times the odds of burnout symptoms compared to doctors without that pressure. The other two measures had roughly twice the odds of burnout symptoms.

The researchers also found that EHR-related stress is dependent on the physician's specialty.

More than a third of primary care physicians reported all three measures of EHR-related stress -- including general internists (39.5 percent), family medicine physicians (37 percent) and pediatricians (33.6 percent). Many dermatologists (36.4 percent) also reported all three measures of EHR-related stress.

On the other hand, less than 10 percent of anesthesiologists, radiologists and hospital medicine specialists reported all three measures of EHR-related stress.

While family medicine physicians (35.7 percent) and dermatologists (34.6 percent) reported the highest levels of burnout, in keeping with their high levels of EHR-related stress, hospital medicine specialists came in third at 30.8 percent. Gardner suspects that other factors, such as a chaotic work environment, contribute to their rates of burnout.

"To me, it's a signal to health care organizations that if they're going to 'fix' burnout, one solution is not going to work for all physicians in their organization," Gardner said. "They need to look at the physicians by specialty and make sure that if they are looking for a technology-related solution, then that's really the problem in their group."

However, for those doctors who do have a lot of EHR-related stress, health care administrators could work to streamline the documentation expectations or adopt policies where work-related email and EHR access is discouraged during vacation, Gardner said.

Making the user interface for EHRs more intuitive could address some stress, Gardner noted; however, when the research team analyzed the results by the three most common EHR systems in the state, none of them were associated with increased burnout.

Earlier research found that using medical scribes was associated with lower rates of burnout, but this study did not confirm that association. In the paper, the study authors suggest that perhaps medical scribes address the burden of documentation, but not other time-consuming EHR tasks such as inbox management.

 

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HHS Studying Modernization of Indian Health Services’ IT Platform

November 29, 2018
by David Raths, Contributing Editor
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Options include updating the Resource and Patient Management System technology stack or acquiring commercial solutions

With so much focus on the modernization of health IT systems at the Veteran’s Administration and Department of Defense, there has been less attention paid to decisions that have to be made about IT systems in the Indian Health Service. But now the HHS Office of the Chief Technology Officer has funded a one-year project to study IHS’ options.

The study will explore options for modernizing IHS’ solutions, either by updating the Resource and Patient Management System (RPMS) technology stack, acquiring commercial off-the-shelf (COTS) solutions, or a combination of the two. One of the people involved in the analysis is Theresa Cullen, M.D., M.S., associate director of global health informatics at the Regenstrief Institute. Perhaps no one has more experience or a better perspective on RPMS than Dr. Cullen, who served as the CIO for Indian Health Service and as the Chief Medical Information Officer for the Veterans Health Administration

During a webinar put on by the Open Source Electronic Health Record Alliance (OSEHERA), Dr. Cullen described the scope of the project. “The goal is to look at the current state of RPMS EHR and other components with an eye to modernization. Can it be modernized to meet the near term and future needs of communities served by IHS? We are engaged with tribally operated and urban sites. Whatever decisions or recommendations are made will include their voice.”

The size and complexity of the IHS highlights the importance of the technology decision. It provides direct and purchased care to American Indian and Alaska Native people (2.2 million lives) from 573 federally recognized tribes in 37 states. Its budget was $5.5 billion for fiscal 2018 appropriations, plus third-party collections of $1.02 billion at IHS sites in fiscal 2017. The IHS also faces considerable cost constraints, Dr. Cullen noted, adding that by comparison that the VA’s population is four times greater but its budget is 15 times greater.

RPMS, created in 1984, is in use at all of IHS’ federally operated facilities, as well as most tribally operated and urban Indian health programs. It has more than 100 components, including clinical, practice management and administrative applications.

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About 20 to 30 percent of RPMS code originates in the VA’s VistA. Many VA applications (Laboratory, Pharmacy) have been extensively modified to meet IHS requirements. But Dr. Cullen mentioned that IHS has developed numerous applications independently of VA to address IHS-specific mission and business needs (child health, public/population health, revenue cycle).

Because the VA announced in 2017 it would sundown VistA and transition to Cerner, the assessment team is working under the assumption that the IHS has only about 10 years to figure out what it will do about the parts of RPMS that still derive from VistA. And RPMS, like VistA, resides in an architecture that is growing outdated.

The committee is setting up a community of practice to allow stakeholders to share technology needs, best practices and ways forward. One question is how to define modernization and how IHS can get there. The idea is to assess the potential for the existing capabilities developed for the needs of Indian country over the past few decades to be brought into a modern technology architecture. The technology assessment limited to RPMS, Dr. Cullen noted. “We are not looking at COTS [commercial off the shelf] products or open source. We are assessing the potential for existing capabilities to be brought into “a modern technology architecture.”

Part of the webinar involved asking attendees for their ideas for what a modernized technology stack for RPMS would look like, what development and transitional challenges could be expected, and any comparable efforts that could inform the work of the technical assessment team.

 

 

 


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