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AHA Calls for Reforms to Stark, Anti-Kickback Laws to Remove Barriers to Care Coordination

July 6, 2016
by Heather Landi
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The American Hospital Association (AHA) released a report that proposes that the Stark and Anti-Kickback laws and regulations impede hospitals’ ability to coordinate care and calls on legislators and regulators to reform these regulations in order to remove those legal barriers.

AHA shared the report, titled “Tackling Outdated Regulatory Barriers that Impede Health Care Transformation,” with Congress and the U.S. Department of Health and Human Services (HHS) in order to examine what the organization sees as barriers to transforming health care delivery created by outdated fraud and abuse laws. AHA contends that aspects of the Stark Law, which addresses physician self-referral, and the Anti-Kickback Law are impeding the types of collaborative arrangements between hospitals and physicians that are needed to transition to value-based care delivery. And, in the report, the organization also recommends how to tackle those regulatory barriers.

“The new payment models being promoted by policymakers and embraced by the hospital field create accountability for the health of a patient beyond an inpatient admission, an outpatient procedure or an office visit – a responsibility that requires hospitals, physicians and other health care providers and professionals to work as a team and with the patients they care for. Common goals, aligned incentives and a regulatory structure that supports rather than impedes those efforts are essential to success,” Melinda Reid Hatton, general counsel and senior vice president at AHA, wrote in a blog about the report.

The AHA report comes on the heels of a white paper released last week by Senate Finance Committee Chairman Orrin Hatch (R-UT) examining aspects of the Stark law that prevent healthcare providers from moving to alternative payment models. 

Healthcare stakeholders have cited the need to modernize the Stark Law as the nation pursues coordinated care as a means to improve quality and reduce costs. According to the white paper released by Sen. Hatch, the Stark law prohibits a physician from referring Medicare patients for “designated health services” (DHS) to an entity with which the physician has a financial relationship, unless an exception applies, and that regulation can impact electronic health record (EHR) access to affiliated providers and hospitals.

The AHA, in its report, cites seven regulatory barriers that need to be tackled and several of those barriers involved health IT. Specifically, AHA assets that “impractical limits on sharing EHRs and analysis tools needed to improve and coordinate care” as one major regulatory barrier.

“Under new models of payment, hospitals are financially responsible for creating an efficient care team that achieves lower costs and higher quality. The underpinning for a care team to do its best in meeting the needs of a patient—enabling him or her to achieve and maintain the best health outcome—is to have ready access to the information necessary to make informed decisions about the patient’s care,” the AHA report stated.

“The certified electronic health record (EHR) is one component of the shared infrastructure that is necessary for a well-coordinated care team. When providers across the care continuum utilize certified EHRs that are connected, all benefit from having the ability to access and use information about the patient’s condition and history that supports their role on the care team,” the AHA report authors wrote.

However, AHA contends that current rules for providing an EHR do not allow hospitals to bear the full cost; “instead, physicians must bear a portion of the costs, without regard to the contribution they otherwise make to the collaborative effort.”

And further, the AHA report authors wrote, currently there are no exceptions for a hospital to provide data analytic tools to assist physicians in making treatment decisions for patient.  These tools would enable physicians to assess data from various sources and identify clinical pathways for specific conditions, medical histories and patient populations, the AHA contends.

“Investing in needed infrastructure is a pre-condition for implementing new payment models. The Stark and Anti-Kickback Laws should be modernized to permit hospitals to subsidize the start-up costs needed to meet the objectives of these new payment models,” the AHA report authors stated.

The AHA report contends that anti-fraud laws restrict hospitals and physicians from providing assistance to patients to them recover faster after they leave the hospital, including self-monitoring digital health tools, such as scales or blood pressure cuffs.

The AHA report authors stated, “The Anti-Kickback Law also applies to a hospital’s relationship with a patient. The general prohibition on providing anything of value to ‘induce’ the purchase or order of items or services paid for by the Medicare program also applies to assistance to patients. Providing vouchers for a cab ride to an appointment, scales to monitor weight loss or cuffs to monitor blood pressure are ‘remuneration’ that could be characterized as a prohibited inducement. There is no exception in the Anti-Kickback Law protecting these patient benefits.”

To address these barriers, AHA proposes modernizing the laws, specifically recommending that Congress grant wider exemptions. “The fraud and abuse laws need to be adapted to support not hamper the new payment models. To that end, Congress should create legal safe zones to support and foster arrangements designed to achieve the goals of payment-for-value rather than volume-based programs," the AHA report authors wrote.

Further the report states, “Hospitals and physicians should not have to spend hundreds of hours or thousands of dollars in hopes of stringing together components from the existing exceptions and safe harbors or developing inefficient work-arounds to achieve the goals of alternative payment models (APMs). Nor should hospitals be limited in their ability to provide patients the full spectrum of assistance they need to recover. There should be clear and comprehensive protection for arrangements designed and implemented to meet those goals."

AHA notes that HHS has used its statutory authority to grant waivers of the Anti-Kickback, Stark and CMP Laws for participants in certain programs such the MSSP and bundled payment programs. However the current patchwork waive approach will not provide sufficient protection to providers as participation in integrated payment and delivery models increases, the AHA report authors argue.

To modernize fraud and abuse laws and remove these legal barriers, AHA recommends enacting new, comprehensive safe harbors under the Anti-Kickback law. Specifically, the new safe harbor should permit support that is financial, such as providing patients with scales to monitor weight .And, AHA proposes that reforms to the Stark Law would “refocus it on physician ownership, its original purpose, which means that compensation would be regulated exclusively under the Anti-Kickback Law.” 



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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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