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How CMS is Following VA’s Lead on Informed Consent

August 25, 2017
by Aaron S. Fink, M.D.
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The frequently quoted adage “the more things change, the more they stay the same” was first penned by a French journalist in 1849. Now over 150 years later, this view seems applicable to today’s healthcare environment.  By way of example, even in this time of tremendous change, the Centers for Medicare & Medicaid Services (CMS) is now addressing an issue that the Department of Veterans Affairs (VA) addressed over a decade ago.

This latest example of national policy mirroring VA practice is the Quality of Informed Consent Documents Measure, which CMS is proposing to add to its Hospital Inpatient Quality Reporting (IQR) program. In the measure’s methodology report, CMS states that “most informed consent documents do not meet a minimum patient-centered standard to support informed decision-making.” Yet as early as 2002, the VA identified concerns within its own informed consent policies and processes that parallel many of those now targeted by CMS.

At that time, in addition to recognizing the significant role the consent process plays in shared decision-making, the VA also understood its business implications—especially delays in operating room (OR) start times caused by misplaced paper consent forms. In response to those concerns, the VA launched its Electronic Support for Patient Decisions (ESPD) initiative in 2004.

Fortunately, today’s health systems can readily implement changes to address the lessons the VA learned as it examined its consent processes during the ESPD implementation. Such changes can not only meet the proposed IQR measure, but can also strengthen the commitment to shared decision-making.

Following the VA’s Example


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CMS notes that although comprehensive informed consent documents enhance patient comprehension and satisfaction, they are seldom given to patients early enough or with sufficient detail and explanation to encourage their involvement in formulating their care plans. The VA came to a similar conclusion, in part due to studies such as Hospital Informed Consent for Procedure Forms: Facilitating Quality Patient-Physician Interaction, which showed that most consent forms failed to contain the basic elements required for adequate informed consent.  As such, these forms appeared designed to authorize treatment and protect providers from liability rather than providing critical information needed to help patients make better health decisions.

Aaron S. Fink, M.D.

Mindful of such research, during its ESPD program the VA considered a software approach to support the informed consent process. The goal of this approach was to automate and standardize the informed consent process to ensure consistent provision of detailed, easy-to-understand, procedure-specific consent documents for the thousands of services and procedures performed in VA medical centers.

At the time of the ESPD program (2004), the VA’s VistA Computerized Patient Record System (CPRS) was arguably one of the best EHR infrastructures available. This system allowed the VA to deploy an automated solution for generating and documenting consents within its EHR. Obviously, since that time the nationwide proliferation of EHRs has facilitated widespread use of automated consent tools in hospitals and practices outside the VA.

Deployment of such automated consent solutions offers several critical benefits in achieving compliance with the Quality of Informed Consent Documents Measure. First, the measure requires providers to enter detailed language describing the procedure, the reason for performing the procedure, the risks, benefits and alternatives. Software that draws on a database of previously-vetted consents offers a practical solution for reproducibly generating comprehensive and legible forms (the measure proposes an additional point if the content is typed) specific to the proposed treatment.

The second way automation can aid compliance with the measure involves timing. In the proposed measure, 25 percent of the score is earned by obtaining and documenting the patient’s consent at least one day before the procedure occurs. As CMS has realized, the time consent is obtained has proved to be a crucial factor when seeking to enhance shared decision-making via informed consent. In fact, as my colleagues and I have reported, the time spent in the consent discussion is one of the most powerful predictors of patient comprehension. We found that the optimal amount of time for the conversation was 15 to 30 minutes—an amount of time that usually isn’t practical in a rushed pre-op environment.

Although the CMS measure only requires consent forms to be signed the day prior to a procedure, the VA altered its consent policies to allow the pre-operative discussion and form execution to be completed as early as 60 days prior to the procedure (subject to certain limitations). Such workflow adaptations allow providers to print documents for patients to take home so they can review and then ask questions well in advance of the day before their procedures. Thus, the VA redesigned its consent process emphasizing shared decision-making while facilitating capture and retention of the signed document.

Benefits beyond compliance

If adopted as part of the Hospital IQR Program, compliance with the Quality of Informed Consent Documents Measure should improve an organization’s star rating as well as its opportunity to recover its 2-percent Medicare holdback. As the VA found, however, improving shared decision-making through a detailed consent process also can yield other advantages, including:

Improved OR utilization: A 2013 study by Johns Hopkins University’s Department of Surgery found that in 66 percent of OR cases, signed paper consent forms were not immediately available at the time of surgery. These misplaced forms led to a delay in 14 percent of OR cases. Given the expense of running active operating suites (estimated to cost hospitals up to $60 per minute), the cumulative financial cost attributable to OR delays can be staggering.

Use of an automated consent process allows consent documents to be signed electronically during the shared decision-making discussion days or weeks before the procedure. Indeed, as noted above, the VA altered its policies to allow either physicians or physician extenders to pre-prepare forms electronically well in advance of a patient encounter without finalizing them. Then, providers could access the document from the EHR, go through it with the patient, answer any questions and obtain signatures well before the day of surgery.

Lower malpractice-related expenses: In the 11 years before the VA began its ESPD initiative, about 1.5 percent of its tort claims were primarily associated with inadequate informed consent. Although a small portion of overall VA tort claims, these cases still resulted in financial judgements of approximately $50,000 a year as well as millions of dollars in legal expenses.

Inadequate informed consent is a significant legal risk. One 2004 legal review found that even when consent is not central to the plaintiffs’ allegations, it is often leveraged as additional evidence against physicians, or “as an alternative point of attack when the case is otherwise weak.”

Clearly, detailed patient- and procedure-specific consent forms can greatly reduce liability risk. Some electronic consent tools can even generate a progress note in the EHR to document when the consent discussion occurred as well as details discussed during the encounter. At a minimum, automation at least provides date- and time-stamps (a JCAHO requirement) on easily accessible completed forms.

Fully Informed and Shared Decisions

There is one additional aspect of CMS’s informed consent quality measure that goes beyond the VA’s 2004 ESPD initiative. The measure requires providers to quantify the probability of at least one procedure-specific risk to the patient. The American College of Surgeons’ National Surgical Quality Improvement Program Surgical Risk Calculator—which provides quantitative risks for more than 1,500 surgical procedures—might offer significant assistance in this regard if amalgamated with an automated informed consent process.

While new and unusual, the quantified risk probability is another element that CMS likely hopes will transform the informed consent process from a formality into a true shared decision-making discussion. Together, physicians and patients can work toward a meaningful understanding of a procedure’s benefits and risks in a comfortable environment, ensuring that care aligns with each patient’s expectations, preferences and goals.


Aaron Fink, M.D., is professor emeritus of surgery at Emory University. He was chief of surgical service at the Atlanta VA Medical Center during the pilot program and implementation of the VA’s Electronic Support for Patient Decisions initiative.

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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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