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Health IT

A new health IT partnership aims to improve clinical data quality and thereby increase the volume of data available for care quality measurement.

The partnership will combine Chicago-based Apervita and Farmington, Connecticut-based Diameter Health’s expertise to provide payers, providers and other healthcare stakeholders with access to clean clinical data for value-based care delivery, said Rick Howard, Apervita’s chief product officer, in an email.

“The healthcare industry has no shortage of data, but the way it’s leveraged continues to be a challenge for both quality measurement and for supporting value-based contracts,” he said.

Apervita provides stakeholders with the infrastructure necessary to develop value-based care models.

Per the new partnership, the company’s quality measurement and value optimization solutions will leverage Diameter Health’s Fusion engine to clean healthcare data in multiple formats, including clinical, claims, behavioral health and laboratory data, Howard explained.

The clean data can be used to glean performance insights that are needed to develop value-based contracts between providers and payers.

Diameter Health’s technology ingests raw — that is, poorly formed, unstructured or incorrectly coded — health information from EHRs, labs and aggregators, and automatically normalizes, re-organizes, deduplicates and summarizes the data, said a Diameter Health spokesperson in an email. The technology identifies data quality errors early in the ingestion process, which makes data sharing more efficient.

“We are thrilled to be a critical and foundational component to Apervita’s platform by delivering clean, normalized, and enriched multi-source clinical data to their customers, empowering providers, payers and other healthcare stakeholders to improve quality and deliver value,” said Eric Rosow, CEO of Diameter Health, in a news release.

Healthcare data is proliferating as the industry becomes more digitized. Telehealth and remote patient monitoring services, in particular, grew exponentially amid the Covid-19 pandemic. And the data generated by these services also grew.

In addition, wearable health technology, like glucose monitors and the Apple Watch, are becoming more widely used to track patient diagnostics and encourage patient engagement, Howard said. This provides even more data for the healthcare industry to contend with.

“As the volume of healthcare data continues to grow, so will the need to have technology that normalizes the data so that it can be used to support quality measurement, value-based contracts and analytics,” he said.

Photo: Dmitrii_Guzhanin, Getty Images

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The Covid-19 pandemic has affected every sector of our society and requires coordinating a broad coalition of assets to contain it. The response includes multiple federal and state government agencies, thousands of hospitals, and a broad swath of commercial manufacturing capabilities and supply chains. We saw this coordination and collaboration early on with personal protective equipment and ventilators, and we see it again as we ramp up vaccine distribution.

To coordinate an effective response, it is critical to integrate disparate data types from multiple domains and sources, something that has been a long-standing challenge in health care. Obstacles include government agency budget structures that don’t incentivize data sharing and legacy databases that create barriers to data integration. The commercial sector also brings the challenges of competition and proprietary systems. Even seemingly simple questions, such as how many ICU beds are available in a community, are maddeningly difficult to answer in near real time. While well-branded and user-friendly websites provide impressive updates on case counts, emergency operation centers have found it challenging to integrate that data with bed availability, hospitalization projections, work force data, supply chain data, mitigation interventions, social determinants of health, and other key data elements that allow for effective planning and response.

In addition to the public health challenges, new care delivery models have underscored the need to better integrate data to deliver care for chronic diseases. The pandemic has accelerated the adoption and use of telehealth. But again, tools, sensors, apps, and devices are often deployed on disparate data platforms that make it cumbersome for patients and providers to integrate data in a meaningful fashion.

The pandemic illustrates the need for better data integration to improve management of this crises as it continues to impede the everyday care of patients.

Lessons learned from defense and intelligence communities
The health industry lags behind other commercial sectors in its adoption of data management and open-source innovations. The health community can learn a great deal about data management from defense and intelligence agencies, which must integrate vast amounts of data from disparate systems to create a common operating picture to support life and death decisions for warfighters.

The 9/11 attacks demonstrated that data gaps can be deadly. The 9/11 Commission Report revealed that information that could have prevented this tragedy was scattered across several different intelligence agencies’ databases. Following the Commission’s critique, the intelligence agencies adopted low schema data “lakes” that could accommodate multiple “streams and rivers” of disparate data and allow for easier integration. Think of these data systems as giant spreadsheets, with each cell containing an entry item. With automated meta-tagging, each cell of information can be correlated with any other item of data to reveal patterns that would otherwise have gone undetected. These data platforms also enabled the accumulation of massive data stores that optimize advanced analytics and artificial intelligence. Intelligence agencies also benefited from security protections at the individual cell level that enhanced data security, an important feature to consider as health information increasingly comes under cyberattack.

The intelligence community also embraced open source tools and open architectures for these data systems. Open source allows the rapid development of new tools at lower cost. Open architectures avoid costly and stagnating vendor lock, and it enables the adoption of new best-in-class tools and capabilities as they are often developed by small niche firms and start-ups

While novel 15 years ago, many of these innovations have been avidly adopted in the commercial sector. However, the same cannot be said for the health domain. That said, there are notable exceptions that are bright spots on the health care landscape.

Advana: Uniting disparate systems and users on a common platform
Advana, a Department of Defense (DoD) data platform, pulls together more than 200 business systems across the DoD and makes data discoverable, understandable, accessible, and usable for advanced analytics for more than 17,000 users across the Army, Navy, and Air Force who need to make decisions about mission readiness, contracts, supply chain logistics and more. The platform has helped the DoD coordinate its Covid-19 response by enabling the easy integration of a wide range of data, including case, bed, supply chain, readiness, and financial data, to inform critical health care decisions. The open architecture platform supports multiple projection models and analytic tools, which allows the DoD to validate findings in a way that would not have been feasible with a single approach.

Advana faced many of the data integration obstacles familiar to health care IT leaders: non-standard interfaces, duplicate data and systems, legacy technologies, and a history of different units pulling their own data for decision making. To integrate disparate data from spreadsheets, application programming interface (APIs), database dumps, and data warehouses from across the enterprise, Advana streams data feeds, automatically categorizing, tagging, and transforming them into a common data model to improve enterprise level analytics.

Preparing for the next health crisis
The value of big data in health care is clear but unless we can integrate and correlate disparate types of data, we can’t realize the benefits. The data challenges of the Covid-19 response illustrate this issue. The seams between government agencies, health systems, and departments within the same organization create chronic barriers to data sharing. Few organizations manage more data than the defense and intelligence agencies, and as with health care, their decisions often have life and death consequences. For critical decisions, they have developed effective strategies to create a common operating picture through robust data integration. As we continue to respond to this pandemic and prepare for the next crisis, the health care community should learn from these mission critical organizations.

Editor’s Note – The author is a Department of Defense consultant.

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The journey toward achieving interoperability in healthcare needs to now move beyond data exchange, and instead, focus on data management.

This is the opinion of a panel of experts who gathered at the all-virtual Health Datapalooza and National Health Policy Conference Thursday to discuss one of healthcare’s most hotly debated concepts: interoperability.

The healthcare industry has come a long way with regard to interoperability, especially with the new rules proposed by the Department of Health and Human Services, set to take effect April 5. These rules aim to provide patients with unprecedented access to their data.

But the healthcare problems of today require solutions that support data management, and not just data exchange, said Claudia Williams, CEO of California-based Manifest MedEX, at the Health Datapalooza conference.

The industry has focused on enabling the basic exchange of health records between providers and made great progress, but the connective tissue that enables data management — including matching and cleaning data — is lacking, she said. And it’s the smaller providers that are being left behind.

“In California, a slim share of the health delivery systems, mostly the big health systems, have hundreds of people doing this work, and safety net providers and small Medicaid plans and others really are stuck with just being able to pile up CCDAs [consolidated clinical document architecture] or maybe not even process CCDAs at all,” she said.

There needs to be policies and strategies enacted at the state and federal levels to create an infrastructure that has more to do with the management of data than with health record exchange, Williams said.

While policy actions are necessary, there also needs to be more alignment between the needs of the providers on the ground and the health IT technology and capabilities available today, said Dr. Farzad Mostashari, CEO of Bethesda, Maryland-based Aledade, during the panel discussion.

Through Aledade, which operates accountable care organizations in partnership with more than 800 primary care practices, Mostashari has experienced that disconnect firsthand.

“What EHRs do today have nothing to do with what I need,” he said. “Well, not nothing, but they really don’t fill the thermometer of what I need to do for population health.”

It is costing Aledade millions to map, match and translate EHR data, he added.

Looking ahead, care quality measurement needs to be automated within the EHR and providers should get free access to information that is already mapped in accordance with data standards, Mostashari said.

The technical tools needed to push interoperability forward already exist, but the regulatory landscape needs to catch up, said Donald Trigg, president of North Kansas City, Missouri-based Cerner, during the session.

The government is now both the biggest healthcare regulator in the country and the biggest payer. This means it is in a unique position to use health IT certification and provider reimbursement to help create the interoperability architecture that is necessary for the coming decade, Trigg said.

“I’m still an optimist,” he said. “And I think that Covid and this administration will be an accelerant for the next wave of meaningful data exchange.”

Trigg’s advice for the new administration’s HHS is to tackle the inter-agency complexity that exists at the federal level.

Coordination between agencies like the HHS, Federal Trade Commission and Food and Drug Administration is necessary. This means, it will be important to create clarity around the inter-agency landscape and data management so that the healthcare industry can innovate and do more, Trigg said.

Photo: LeoWolfert, Getty Images

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The Covid-19 pandemic spurred the use of technology, but with growing use comes new challenges.

Southfield, Michigan-based Beaumont Health experienced this firsthand at the end of January, when an unknown user took advantage of an Epic scheduling tool vulnerability. But the incident served as a teachable moment, with the system quickly working to safeguard its vaccine scheduling process, said Beaumont Health Chief Information Officer Hans Keil in a phone interview.

The user publicly shared a link to the scheduling module for the clinic providing Covid-19 vaccines. This allowed 2,700 people to register for an unauthorized vaccine appointment, all of which had to be canceled.

Keil believes that the high level of demand for Covid-19 vaccine is what ultimately led to this incident.

“We had challenges with demand,” he said. “We had to triple our server capacity to be able to support the public and their high interest in getting vaccinated.”

When the vaccine rollout began, Beaumont was leveraging technology already available via its Epic EHR system. It had previously used this technology to schedule influenza vaccinations and conduct serology testing last April.

But the Epic system did not have the ability to send out randomized invitations for vaccinations, Keil said. It was important for the health system to be able to randomize that process to ensure it was administering the vaccine equitably. So, Beaumont set up that capability themselves and improved its server capacity to field the high level of demand. But that still left a gap in the process within the Epic EHR.

The vaccination scheduling process was running smoothly until the unknown user found a way to exploit that gap, short-circuit the registration and go straight to the scheduling tool, Keil said.

It was a sudden spike in traffic that alerted the health system’s IT team to the breach. The health system shut down its Covid-19 vaccination registration and scheduling services, for close to 24 hours.

Now that nearly two weeks have passed since the incident was discovered and addressed, Beaumont is focused on preventing this from happening again.

In the short term, the health system is monitoring its IT traffic and making sure every pathway coming through is legitimate, said Keil.

In addition, Epic now offers the capability to randomize vaccination invitations within their EHR. Going forward, the health system will use that capability as well as other enhancements that Epic has made to make sure it is “one individual, one ticket, one opportunity to schedule,” said Keil.

Keil does not envision any further IT issues arising in scheduling upcoming Covid-19 vaccinations. But high demand remains a concern.

“We just need to make sure that we maintain the integrity of this process and we be as fair as possible,” he said. “These tools, these platforms were never meant for this kind of demand. Epic didn’t think about that way, we didn’t think about it that way. But it’s different now.”

In some ways, the pandemic has sharpened the focus of the health system’s IT team.

Beyond the rollout, Keil and his team are thinking about how to help get the system’s surgery volumes up to help with financial recovery. This will include creating end-to-end experiences around surgery services and increasing the level of digital engagement among patients.

“You can get spread thin on lots of priorities,” Keil said. “This [public health crisis] makes it a lot more crystal clear as to what’s most important…to make a difference for the experience of patients and the financial health of the system.”

Photo: bsd555, Getty Images

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Even as the novel coronavirus was raging in the U.S. last year, providers were concurrently fighting a different scourge: hackers. 

Several major providers experienced IT incidents in 2020, including the 26-hospital Universal Health Services and University of Vermont Medical Center. Last week, Pittsburgh-based UPMC and Omaha-based Nebraska Medicine announced that they too are on the list.

It’s not just providers who are targets.

Charles J. Hilton & Associates P.C. — which provides billing-related legal services to UPMC — alerted the health system that the personal data of more than 36,000 of its patients may have been compromised due to an information security breach. The company determined that hackers had logged into several of its email accounts between April 1 and June 25. The accounts contained various types of information, including Social Security numbers, dates of birth, bank or financial account numbers, insurance information as well as information related to diagnoses, treatments and medications.

The incident did not affect UPMC’s EHR or other computer systems, and there is no evidence that the data was misused, according to a notice issued by UPMC. Charles J. Hilton & Associates is offering credit monitoring and identity protection services to all individuals whose data was impacted.

Similarly, Nebraska Medicine and the University of Nebraska Medical Center discovered that an unauthorized party gained access to its shared network between Aug. 27 and Sept. 20, 2020. The unauthorized party deployed malware and acquired copies of some patient and employee information, including names, addresses, insurance information and clinical information. The Social Security numbers of some patients were also impacted.

In all, the data breach affected approximately 219,000 individuals.

The unauthorized party did not gain access to Nebraska Medicine and University of Nebraska Medical Center’s EHR app, and there is no evidence that any of the impacted data has been used fraudulently, the organizations said. But they are providing complimentary credit monitoring and identity theft protection services to all individuals whose Social Security numbers or driver’s license numbers were accessed.

“It is an unfortunate reality of our digital age that ‘bad actors’ are a constant threat to healthcare,” said Nebraska Medicine CEO Dr. James Linder in a news release. “Every major healthcare entity faces the same challenge, and we have seen many healthcare systems, businesses, and government agencies that were impacted by a data security attack in the past six months.”

The organizations will review their networks for unauthorized activity and work to strengthen their controls, said University of Nebraska Medical Center Chancellor Dr. Jeffrey P. Gold.

As providers enter 2021, data security will remain top-of-mind as they are the most common targets for cyber criminals attacking the healthcare industry.

From January to October last year, 513 healthcare organizations reported a breach of 500-plus patient records to the Department of Health and Human Services. Of these reported breaches, 404 occurred among providers, affecting approximately 13.5 million patients.

The threat of cyber attacks targeting the healthcare industry is on the federal government’s radar as well.

Three federal agencies released a joint notice in October 2020 warning of a credible cybercrime threat to U.S. providers and asking the industry to remain vigilant.

Photo: anyaberkut, Getty Images

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interoperability

As part of our focus to highlight the confluence of healthcare and legal news, we are featuring interviews with inside counsel at life sciences and other healthcare companies. The first of these interviews features Erich Drotleff, senior counsel for Availity. As the nation’s largest health information network connecting health plans, providers and patients, Availity facilitates over 4 billion clinical, administrative, and financial transactions annually.

At Availity, Drotleff is responsible for negotiating profitable agreements, promoting company growth and profitability, minimizing business risk, ensuring legal compliance, and managing non-lawyer staff. In a phone interview with MedCity News, he weighed in on the role of data-sharing in public health, his path to an in-house role, and the benefits of bonsai gardening.

(This interview has been edited for length and clarity.)

Headshot of Erich DrotleffWhat is the most crucial issue facing health and life sciences lawyers, today, and how would you go about addressing it?

I would have to say information-sharing.

There is so much regulation on data rights, ownership, privacy, and protection that I don’t think we will be able to tap into revolutionary healthcare advancements, such as advanced data analytics using AI and machine learning, until healthcare data can be shared universally.

I know there are serious concerns centered around data privacy and its use that raise many ethical issues. And let us not forget about how truly valuable healthcare data is to hackers; the healthcare sector is one of the largest industries with nonstop data breaches. But for healthcare outcomes to truly advance, we need to have the ability to build a national “data lake” based on inputs from all  stakeholders.

Although the prior administration took steps to lower information blocking, it is still woefully inadequate in providing a meaningful use of and access to necessary healthcare data. Despite the changes initiated by ONC and CMS, too many roadblocks still exist.

The FDA just held a meeting to discuss how to manage data in the development of artificial intelligence for medical devices, and the fact is that you can’t develop anything if everyone’s going to be holding onto their data and saying: “You can’t do anything with it unless it falls within these exact three enumerations under this contract.”

I get that perspective from a company-protection standpoint. And then I get the ethical dilemma from a patient’s perspective — “it’s not your data, it’s my data, it’s about me and my body.” But we need to address it. There’s a lot of discussions around what to do but no solutions, yet. Until we solve this issue there is so much health innovation that’s just going to remain untapped.

What legal industry trends have had the greatest impact on your practice?

When the market crashed in 2008, I was a first-year associate in a small firm. I knew I wanted to go in-house while I started contemplating going to law school and becoming a lawyer as a second career.

However, I didn’t know if many in-house counsel positions were available for someone such as myself, given my prior career as a health plan contracts negotiator.

The 2008 market crash really shook up the legal industry. At law firms, second- and third- to fifth-year associate blood-letting was at an all-time high. Unemployed BigLaw associates were everywhere.

More and more companies were taking their legal work in-house and outsourced less and less once they realized how much they could save for the bottom line by bringing on full-time in-house counsel.

So I guess my first career non-legal work experience combined with a law degree and law firm experience was attractive to many employers seeking to bolster their legal department headcount.

What COVID-19-related change do you think will most impact health and life sciences legal practice, moving forward?

I think telemedicine and remote patient monitoring will continue to grow in both interest and popularity.

But as a result, a significant number of issues will arise. Patient confidentiality, data privacy and data rights, an increase in both use and development of apps, consumer-driven healthcare, and healthcare concierge services. And of course the issue of medical licensing issues across jurisdictions — which state’s medical licensing laws apply?

What is your proudest legal accomplishment (that you’re allowed to talk about)?

I would say my biggest accomplishment since graduating from law school and becoming an attorney was passing the California State Bar the first time!

But as far as during my working career, I took a position in the fall of 2014 at a newly acquired healthcare entity whose parent company had no healthcare legal leadership. My biggest success story was being a one-man legal department and building out the subsidiary so it was aligned with the parent company’s business rules while also making sure the organization was running consistently with necessary healthcare regulations.

They needed a good healthcare attorney with business acumen that understood the landscape as it applied to the healthcare industry, and I was proud to be that person.

What do you wish you could teach your younger self about health and life sciences law, before you went in-house?

That question is a bit difficult to answer since I knew from the moment that I decided to commit to prepping for applying to law school that I wanted to be an in-house counsel and bypass the law firm track.

Unfortunately, most in-house positions require some law firm experience in order to have a well-rounded in-house candidate. So I would tell my younger self to be patient and just realize that all good things take time. Even if that means working at a law firm first before getting that first in-house position.

Having spent years as a health plan contracts manager, what I learned from working at a firm was a better perspective of balancing and managing business risk.

In BigLaw practice, you do everything to ensure your client has slim-to-no risk when they enter into a transaction, but if you continue with that mentality as in-house counsel, you’ll bring the company to a screeching halt. Working at a firm, I developed that necessary understanding that every transaction has a certain risk and applied that to my existing business experience to astutely quantify that risk, evaluate the danger, and advise leadership on the path forward.

There are few business situations that are simply an obvious yes or no, from a risk analysis perspective.

In-between, you can have high return and a high level of risk but low likelihood of a bad outcome. In these cases, you can balance those perspectives and move forward having the ability to tell the organization yes, this does carry a risk, and yes, repercussions could be significant, but the likelihood of it occurring is low.

In my prior career, risk wasn’t on my radar — my marching orders were to negotiate the contracts, close the deals, and move on.

My experience in BigLaw gave me the perspective: “Oh, if this happens, the resulting outcome could be severe.” Most traditional BigLaw attorneys are very risk-averse and carry that mentality into the organization as their in-house counsel.

Historically, an organization’s legal department was often called the “Department of No.” Sometimes they get a bad rap, but I think that’s evolving.

If you could snap your fingers and have the general public understand one thing about health and life sciences, what would it be?

It would have to be for people to understand when they say “don’t let the government take over my healthcare,” that while the two largest health plans in the United States are Medicare and Medicaid, these government programs are administered by private health plans such as Humana, Anthem and United. So when I hear people say they don’t want a nationalized single payer, government-run health system, I have to laugh. Little do they know how Medicare and Medicaid are run.

What three titles would be on your Zoom bookshelf if you were interviewed by CNN?

The three titles would be: “Tribal Leadership” by Dave Logan and John King, Philip Roth’s “The Plot Against America,” and “Cultivating and Growing Bonsai,” because I am a gardener and find it incredibly therapeutic.

“Tribal Leadership” gives a good perspective of high-performing versus low-performing organizations. The authors discuss the different levels of tribal leadership. It’s all about “me,” then it’s all about “us,” and at the higher levels of organizational leadership who “wins” doesn’t matter.

“The Plot Against America” was adapted into a miniseries on HBO, but I read the book first and it had a tremendous impact on me. It’s fiction but pulls on a lot of events that occurred in the 1940s regarding the Jews being persecuted.

In the novel, Charles Lindbergh defeats FDR and serves as the henchman to protect the U.S. from Germany during the 1930s and ’40s. With what’s been going on these past four years, with how the administration allowed white supremacists to get a free pass, it’s an interesting analogy to read this fiction based on real-life events and see how it unfolded.

Bonsai falls in with my passion for gardening and plants; you’ve just got to have the space to keep them outside. If I hadn’t become a lawyer, I would have probably become the owner and operator of a small café, bookstore, garden shop and nursery.

Photo: DrAfter123, Getty Images

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interoperability

Every year at this time, it feels like the movie Groundhog’s Day for many in the payer community. New members, that can run into the tens of thousands, are onboarded. For those in care management, it’s a mad scramble to obtain patient medical histories. The amount of time, energy, and resources spent on largely manual processes continues to be exasperating.

Take Medicare, for example, where more than 840,000 baby boomers aged into the system and enrolled between 2019 and 2020. When these new members are onboarded, care management teams have a very challenging time attempting to close gaps in care. Common questions such as, “when was the last time a member had a mammogram, and what were those results?” are often difficult to answer because of healthcare’s infamous data silos that ensure patient information remains trapped.

Chronic fatigue syndrome
Payers employ teams of people whose full-time job is calling a doctor’s office, requesting information, and waiting weeks for the data to be mailed in hard copy or other physical media such as CDs —or being required to physically drive to the provider location to pick up records. The onus of collecting patient records doesn’t stop with care management.

During reporting periods for HEDIS/STARS measures or risk adjustment evaluations to set rates for plans, administrative teams must chase down records. This Herculean task often requires extra help from outside firms during the January to April crunch time. Many providers find multiple people from multiple departments from the same payer organization requesting the same type of information over and over again in a single year. The result is extraordinary expense and unnecessary fatigue in a records collection process that repeats itself every year.

Interoperability struggles
2020 was supposed to be The Year that would kick health data interoperability into high gear. The Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid (CMS) issued their highly anticipated rules that are intended to improve data interoperability and to prevent information blocking. The rules specify the interoperable data and technology standards for sharing medical records between patients, doctors and payers. The goals are to give patients greater access and control over their medical information to make better healthcare decisions and to spur the type of consumer innovation that is seen in almost every other industry except healthcare.

Those rules have been delayed twice due to difficulties with payers and providers implementing the standards; and then there was also the pandemic. While it remains to be seen if April 2021 will indeed be the effective date for compliance, and many companies are actively advocating for additional delays, one thing we do know is that neither payers nor providers are completely ready for it.

According to a recent survey by Accenture, fewer than one in five (18%) of the executives surveyed in key leadership positions at U.S. healthcare companies said they are “very familiar” with the new regulations, while 17% said they are completely unaware of it. In another survey by the eHealth Initiative, 64% of payers said their top concern is their ability to implement and maintain the application programming interfaces (APIs) that are required for patient access. This concern dwarfs the results of the next top issue by a large margin which is compliance with the rules where only 14% of payer executives said they were concerned about their ability to adhere to the interoperability laws.

This is not especially surprising given that payers have built compliance capabilities to follow the letter of the law in a heavily regulated health insurance industry. However, interactions with patients are centered around the administration of benefits while they are members. Payers have not traditionally dedicated IT resources to building and maintaining technology to directly engage patients, collect and share health information across their care journey geographically and through time longitudinally. Therefore, it’s also not especially surprising that 79% of payers said they definitely would or probably would use vendor solutions to help meet required deadlines.

Working with a Vendor
If the preferred route is to work with a health IT vendor, and all indications are that payers will need to seek outside help with at least some aspects of interoperability and patient access, here are three important things to consider:

  • Can the vendor handle advanced data? As interoperability increases, more complicated data types will be required as part of the essential health information (EHI) of a patient. Already, the newly defined U.S. Core Data for Interoperability standard expands the criteria for clinical data from its more simplistic forms such as claims data. Patients have the right to ask for and receive more advanced data such as medical imaging and digital pathology. Advanced data contains clinical data of significant value that are crucial to care delivery, chronic and complex disease management, and treatment innovation.
  • Is it a mature solution? Common concerns that I often hear is trepidation in dealing with startups without a track record on reliability, scalability, security and credibility. How do you trust that patient data is being handled with care? That is why it’s important to look for vendors with a mature solution and a track record. As an industry, we need to innovate, but we also need to be measured in our choices and not be fooled or distracted by promises of the next disruptive technology that may never be delivered. With no time to waste, the healthcare industry should rely on proven scale capabilities, even if they are not perfect, and build upon them systematically.
  • Look for “off the shelf” API tools that you can use to access medical networks such as Health Information Exchanges (HIEs) and other data networks that support common standard such as HL7 and FHIR. Payers can then plug and play these API tools to access a broad variety of clinical data such as EHR data, labs and imaging. Vendors providing tools should also provide support services for integration into your enterprise systems. Robust service agreements should provide you with comfort knowing that you have a partner to work with you throughout your data interoperability journey.

We all know the upcoming road is going to be tough and will challenge the healthcare industry to share and collaborate in a way it is unaccustomed to. One of the important lessons from Covid-19 is that, paradoxically, the long-awaited and delayed interoperability rules have proven exactly why we need better data sharing.

Photo: DrAfter123, Getty Images

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Care for chronic conditions has been severely disrupted amid the Covid-19 pandemic. To prevent further disruption, providers are increasingly partnering with IT companies.

Mount Sinai Health System and Current Health entered into one such partnership in December, with Mount Sinai implementing the company’s remote patient monitoring solution.

Their goal? To enhance care for cancer patients.

Current Health provides a wearable device to patients, which continuously monitors their vital signs, said Chris McCann, co-founder and CEO of Current Health, in a phone interview. The data is then transmitted back to the patient’s care facility. The solution alerts clinicians if the data indicate any abnormalities or potential care issues. At this point, the clinician decides whether the issue can be managed remotely or if the patient needs to be brought into the hospital.

Over the course of the Covid-19 pandemic, cancer screenings and treatment dropped drastically, which could lead to an increase in patient death rates, researchers warned.

A study published last year in JCO Clinical Cancer Informatics shows that at the peak of the pandemic in April 2020, screenings for breast, colon, prostate and lung cancer decreased significantly as compared to the same period the year prior. In addition, the number of mastectomies performed reduced consistently from April through July of last year, and colectomies similarly reduced between April and May.

“These problems, if unmitigated, will increase cancer morbidity and mortality for years to come,” the researchers wrote.

For Mount Sinai Health System, the drops in patient volume were striking. In April of last year, New York City was the global epicenter of the pandemic, and Mount Sinai, like other hospitals in the region, had to suspend elective procedures. The health system experienced a 25% decrease in volume in its ambulatory as well as inpatient settings in April, said Dr. Cardinale Smith, chief quality officer for cancer services at Mount Sinai, in a phone interview.

Even now, patient volume is 10% lower than what it was during the same time period last year, “which indicates to us that there are people who are likely staying closer to home to receive treatment,” she said.

This reluctance on the part of patients — to either risk coming into a health facility or traveling to a facility further away from them — was one of the reasons Mount Sinai looked into remote patient monitoring solutions for oncology.

The system decided to deploy Current Health’s solution, funding the implementation through a Federal Communications Commission grant. The rollout is currently in the pilot phase.

“What I’m hoping that we will see is that this gives us another way to monitor our patients and be able…to get them into a higher level of care when needed, and otherwise be able to really treat them in place so that they feel both safe and comfortable,” Smith said. “And also, so that we don’t overwhelm a healthcare system that is already being overwhelmed.”

Another reason for implementing the remote monitoring system was the growing digital divide among patients.

Mount Sinai clinicians saw that some of their patients, including people of color and the elderly, were less likely to use telehealth services, said Smith.

Smith hopes that the solution will help them care for those patients since Current Health provides the wearable devices and tablets that the patients need. The patients are trained on the devices, which are easy to use — even for the less-than-savvy tech user, Smith said.

Similarly, the health system educated and trained their clinicians on the new solution. As it is a novel mode of cancer care delivery, they needed to make sure they answered all their clinicians’ questions and concerns, she said.

The demand for remote monitoring solutions has exploded during the pandemic. Current Health, which received Food and Drug Administration clearance for its solution at the end of 2019, soon saw an explosion in demand, McCann said. The company experienced a 400% expansion of its customer base. This includes the addition of hospital customers like Mount Sinai Health System and Boston-based Massachusetts General Hospital.

“What [remote patient monitoring] does is it expands the criteria of patients who can actually be managed at home versus within a hospital and that has been a huge asset to us as a company — particularly in the [current] moment,” McCann said.

Photo: chombosan, Getty Images

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EHR company athenahealth will pay nearly $18.3 million to resolve allegations that it violated the False Claims Act, though the company denies any wrongdoing.

The vendor engaged in an illegal kickback scheme to increase sales for its EHR platform, athenaClinicals, the Department of Justice said on Thursday. Though athenahealth denies any wrongdoing, it agreed to settle.

The Justice Department claims the company conducted three marketing programs between 2014 and 2020 that violated the False Claims Act and the Anti-Kickback Statute. 

The first involved providing free tickets and amenities to prospective and existing customers for sporting, entertainment and recreational events. These included tickets to the Masters Tournament and the Kentucky Derby. The company also provided luxury accommodations, meals and alcohol, alleges the Justice Department.

Further, athenahealth allegedly paid kickbacks to existing customers through a “lead generation” program. Customers were paid when they referred new prospective clients to the company, the Justice Department claims. They received up to $3,000 for each new client that signed up for athenahealth services.

The Justice Department’s final allegation is that athenahealth entered into deals with vendors that were discontinuing their EHR technology offerings. These deals involved the vendors referring their clients to athenahealth and getting reimbursed based on the value and volume of practices that were converted into athenahealth clients.

The settlement also resolves allegations in two whistleblowers lawsuits. The share to be awarded to the whistleblowers has not yet been determined.

“Across the country, physicians rely on electronic health records software to provide vital patient data. Kickbacks corrupt the market for healthcare services and risk jeopardizing patient safety,” said U.S. Attorney Andrew E. Lelling, in the news release. “We will aggressively pursue organizations that fail to play by the rules; EHR companies are no exception.”

The EHR vendor maintains it is not guilty of the allegations.

“[The company] places the highest priority on compliance with all laws and regulations governing our industry,” said a company spokesperson, who declined to be named, in an email. “While we have full confidence in our robust compliance policies and programs, we agreed to this settlement — under which we admit no wrongdoing — to put this matter behind us and move forward with our critical work on behalf of patients and healthcare providers.”

Further, two of the marketing programs were discontinued before the Justice Department investigation took place because they were not efficient or cost-effective, and the third is in the process of being shut down, she said in a phone interview. The company claims that all three programs complied with guidance from the Department of Health and Human Services.

In 2020, the Justice Department said it collected $1.8 billion from healthcare companies under the False Claims Act, down from $2.6 billion in 2019. One of the largest recoveries last year pertained to health IT developer Practice Fusion Inc., which Allscripts, a competitor of anthenahealth’s, purchased in 2018. Practice Fusion paid the Justice Department $145 million to settle allegations that Purdue Pharma paid it to tweak its EHR software to increase opioid prescriptions.

Photo: Sarinyapinngam, Getty Images 

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A coalition, comprising of health technology companies, providers and nonprofits, announced Thursday that they will establish an initiative to provide people with digital access to their Covid-19 vaccination records.

Two vaccines have so far been approved for administration in the U.S. — one developed by Pfizer and BioNTech, and the other by Moderna. The collaborative effort comes as doses of the vaccines are slowly making their way across the country, and people are figuring out what the next phase of the pandemic will look like.

That new phase will likely present unique challenges, including tracking who gets which vaccine, whether they get a one-or two-dose vaccine, where they receive their vaccine and so on, said Dr. John Halamka, president of Mayo Clinic Platform, in a phone interview. Currently, both Modera and Pfizer/BioNTech’s vaccine require two doses three to four weeks apart.

As the country thinks about opening back up and resuming to pre-pandemic levels of activity, “we [will] need a vaccine credential we can trust,” he said.

Mayo Clinic is just one of the high-profile organizations that have joined the coalition to create the Vaccination Credential Initiative. Others include Microsoft, Mitre, The Commons Project Foundation as well as EHR giants Epic and Cerner.

“We saw this as a critical opportunity to help our healthcare organizations and the world start the recovery process,” said David Bradshaw, senior vice president, consumer and employer solutions at Cerner, in an email. “We know vaccines will play a critical role in that and we wanted to be able to proactively inform and design to the specifications.”

The Vaccination Credential Initiative is developing a QR code that will enable individuals to easily provide their vaccination credentials when needed, Halamka explained.

The coalition has agreed on the standard for how the vaccine credential gets displayed in the QR code, he said. The standard was created by Josh Mandel, chief architect at Microsoft Healthcare, and is called the SMART Health Cards specification. It was developed with a short-term goal of allowing an individual to receive the Covid-19 vaccine or lab results and present these results to another party in a verifiable manner. The specification is based on the W3C Verifiable Credential — a credential that has authorship that can be cryptographically verified — and HL7 Fast Healthcare Interoperability Resources standards.

Now, the coalition needs to work on the “underlying plumbing behind it,” Halamka said. This includes figuring out how the patient gets access to the code after receiving the vaccine from whichever site they select — their doctor’s office, a Walgreens, a CVS, or any other vaccination site. Patients will have full control over their QR code and will be able to access it through any smartphone. They will have also the option of printing it out and keeping a physical copy. 

The coalition’s efforts come on the heels of a much-maligned vaccine rollout. More than 30 million doses of the Covid-19 vaccines have been distributed, but only a little over 11 million have been administered, according to data from the Centers for Disease Prevention and Control.

In an effort to speed up the process, the Trump administration announced Tuesday that it plans to release all reserves of vaccine doses that were initially held back to administer second doses, The New York Times reported. The administration also told states to begin vaccinating every individual 65 and older and people with underlying medical conditions.

Looking ahead, the incoming administration has made it clear that vaccine distribution will be an early priority, with President-elect Joe Biden saying in a speech Thursday that his relief plan will include “hundreds of billions” of dollars for a national vaccination program and public health initiatives like testing and contact tracing, NPR reported. Biden has also committed to having 100 million people vaccinated in his first 100 days.

While that goal seems ambitious, were it to be achieved, getting back to normal will require a verifiable record of people being vaccinated.

Halamka believes that coalitions like this one can have a huge impact on easing that transition.

“When I see nontraditional coalitions coming together — and that means government, academia, industry — all work[ing] together for the benefit of society, we can achieve great change,” he said.

Photo: Teka77, Getty Images

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