The new coronavirus dominated news headlines this year. But what were the biggest health care stories of the year? Advisory Board experts round up their top picks for the year—including three that are not related to Covid-19.

• The first (and second) Covid-19 vaccine is authorized
• The ones digit: The human cost of the new coronavirus
• Joe Biden defeats Donald Trump to become the 46th US president
• The telehealth explosion
• Health care confronted disparities that we can no longer afford to ignore
• Systemness is front and center as hospitals rethink bed capacity
• A new era of site-of-care shifts
• The health care "heroes"
• The Affordable Care Act goes to the Supreme Court (again)
• The health care supply chain fell short
• FDA evaluated a flurry of old and new therapies to treat Covid-19
• New regulation seeks to end information blocking

The first (and second) Covid-19 vaccine is authorized.

By Brandi Greenberg, Vice President, Life Sciences and Ecosystem Research

It's hard to think of a bigger story of 2020 than the coronavirus vaccine. With the entire world watching, pharmaceutical companies revolutionized the vaccine development process, and less than a year later we have not one—but two authorized vaccine's that demonstrated well over 90% efficacy in Phase III trials. This can only be described as a remarkable scientific achievement.

Pfizer and BioNTech's mRNA-based Covid-19 vaccine demonstrated 95% efficacy in Phase 3 trials that enrolled over 43,000 participants. Efficacy hardly varied across age, gender, racial, and ethnic groups. FDA issued its Emergency Use Authorization (EUA) on December 11, and Northwell Health vaccinated the first American (outside of trials) on December 14. In the coming weeks, we anticipate at least 10 million people will receive two doses of the Pfizer vaccine; that's only about half of what we need to vaccinate our current population of front-line health care workers as well as nursing home staff and residents (24 million people total), but it's a good start.

Just released: The U.S. Covid-19 vaccination scenario planning guide

And there's more good news ahead. Moderna's mRNA vaccine, which appears at least as safe and effective as Pfizer's candidate, received FDA authorization on Friday. That means we have two authorized vaccines before end of year, further accelerating our effort to vaccinate that first group of 24 million at-risk individuals. Meanwhile, Johnson & Johnson, Astra Zeneca/Oxford, and Novavax all expect results from their own Phase 3 vaccine trials some time in Q1 of 2021. If those trial results are positive, that not only increases the supply but also diversifies the type of vaccines available to meet the needs of different populations.

But, alas, the Herculean efforts to vaccinate our national (let alone global) population have only just begun. Ironically, the scientific innovation is only step one on our journey to herd immunity. For a successful rollout of the Covid-19 vaccines, pharmaceutical manufacturers must work with governments, production sites, sub-component suppliers (e.g., glass vials), transportation services, distributors, health systems, frontline caregivers, pharmacists, and public health officials to safely and efficiently administer these vaccines around the globe. But that's not all. Manufacturers and health care providers also must:

• Meticulously manage every step of the supply chain to ensure adequate temperature control;

• Disseminate the vaccines to both urban and rural populations, minimizing delays and waste;

• Work with federal, state, and local governments to allocate appropriate amounts of product and communicate transparently about priority groups;

• Track every vaccination to ensure every patient getting a first dose gets the right second dose at the right time;

• Continue gathering data on safety and efficacy, especially for children under 16 and pregnant women; and

• Educate and engage communities to address misinformation and legacy medical mistrust.

While many seem focused on where this train may run off the rails, I'm choosing to focus on hope and my belief that human ingenuity and collaboration will help us surmount these upcoming challenges just as they helped us surmount the scientific ones.

The ones digit: The human cost of the new coronavirus

By Ben Umansky, Expert Partner, Research

Milestones make headlines. The daily case count in the United States first exceeded 100 on March 8. It first surpassed 1,000 only a week later, on March 15. Eight days onward, March 23, over 10,000 cases were reported. The first peak of daily cases occurred on April 6, with over 42,000 cases. Recovery in the Northeast gave way to by spikes in the Sun Belt, and July saw a second peak at over 75,000 daily cases. Daily deaths also rose and fell during the undulating waves of infections, with peaks in late April and again in August lagging those in case counts.

We have not yet reached the third peaks.

Other measures and statistics make headlines, too. Total cases, by definition, only rise—one million in April, ten million in November. Because even small percentages of large numbers grow large themselves, the death count has mounted as well. Tests administered, patients admitted, ICU beds filled and capacity limits breached—all these measures and more describe our aggregate experience.

But this is not only a story of aggregates. The 16,987,911 Americans who have contracted Covid-19 by December 17—and the 309,880 Americans who have died—did so one by one by one. It is their individual experiences, more than any headline or bar chart, that are the story. We may grow inured to the relentless recitation of statistics, but the ones digit shakes us from indifference. Our "it's real" moments came not from government statistics crossing arbitrary thresholds, but from hearing real names. Tom Hanks. John Prine. President Trump. A neighbor. A parent.

That 309,880 have died and not 309,879 is a specific, individualized tragedy felt at this moment by a real family and real friends. That the figure is not 309,881 is a triumph of medicine, of science, of social distancing, and, surely, a bit of luck.

The ones digit asks us to remember that for as much as we have shared this year, every experience is unique. It also asks us to remember those whom a lack of access or testing left uncounted. Statistics, no matter how many significant figures, point us toward truth, but they do not equal it.

Joe Biden defeats Donald Trump to become the 46th US president

By Christopher Kerns, Vice President, Executive Insights

What a difference a decade makes. Ten years ago, the passage of the Affordable Care Act (ACA) proved to be an electoral disaster for Democrats in the following midterm elections. Eight years later, with the most unpopular and divisive aspects of the law effectively repealed (the individual mandate chief among them), protecting the ACA's most popular provisions—protections for pre-existing conditions in particular—became a rallying cry for former Vice President Joe Biden's ultimately successful campaign to unseat President Trump.

As HHS and CMS continue to evolve Medicare's value-based care programs, Biden's appointees will have the option to build upon President Trump's increasingly physician-led options that accelerate site-of-care shifts to lower-cost settings, or offer a big-tent approach that encourages more providers and health plans to participate. Those options, of course, aren't mutually exclusive.

But more important, the stage is now set for a debate on future expansion of coverage. The president-elect faces an uphill battle in Congress (regardless of who controls the Senate) to enact some his party's once-radical ideas: a public option as an alternative for Medicaid expansion, plus a lowered Medicare eligibility age. But by taking control of the federal government's Covid-19 response, the Biden administration will be given an ideal test case for expanding the government's role in health care and coverage. The next several months will be critical. Success could be used as a rallying cry for even more government expansion—maybe even a drive for Medicare-for-all. But bungling the effort will give the GOP an opening to put forth a different vision for ensuring full coverage (increasingly viewed by the public as a worthy goal) using a mix of public and private levers.

Either way, we'll be watching. And I expect to have a very long night of edits the night of January 3, the day of the Georgia Senate runoff elections.

The telehealth explosion

By John League, Senior Consultant, Health Care IT Advisor, and Jordan Angers, Senior Analyst, Health Care IT Advisor

The explosion of telehealth utilization during Covid-19 transformed health care delivery and provided the industry with long-awaited data points to measure the quality of telehealth. Pre-Covid-19, telehealth accounted for only about 0.1% of all visits annually. Even telehealth's biggest advocates had a hard time finding data to prove telehealth's value. And even though volumes have fallen from their peak levels in April and May, they're hovering at about 15% of all visits. That's an enormous shift–going from virtually no telehealth visits to thousands of visits a day–but the data and experience gained are even more valuable to help determine how well telehealth works across different use cases.

Telehealth has proved to be one of the most versatile tools in health care. Because telehealth was the only option for care when in-person care was limited or stopped completely, providers got creative with delivering care virtually. Over the past ten months, telehealth acted as:

• A triage tool: Tele-triage methods kept the "worried well" and mild Covid cases out of the hospital and gave providers time to prep for high-risk cases.

• A method of care continuity: Virtual visits and remote patient monitoring helped patients continue non-Covid-19 related care without risking exposure in hospital settings.

• A means to extend capacity: Remote care allowed quarantined clinicians to continue providing care and remote patient monitoring allowed physicians to monitor hundreds of patients in e-ICUs without doing physical rounds.

• An alternative to personal protective equipment (PPE): Virtual care limited direct patient-physician interaction and protected clinicians from additional exposure. It also reserved limited PPE supplies as physicians didn't need to suit up in new PPE every time a patient required attention.

Even more promising, the change in tele-behavioral health utilization makes clear that telehealth isn't simply an emergency substitute for in-person care. Even as telehealth volumes plateaued at 17% of all specialty visits, behavioral health remains at peak levels of utilization, with telehealth accounting for just under 65% of all psychiatry visits. Behavioral health lends itself to virtual modalities because there's no need for physical touch and early research suggests that patients feel as comfortable, or even more comfortable, using virtual modalities to connect with health care providers. Telehealth also provides much needed capacity in the behavioral health space. Even before the pandemic, demand for behavioral health was much higher than supply and the pandemic only increased that imbalance.

If 2020 was the long-awaited tipping point for telehealth, it's important to use the lessons learned and available data to sustain progress in 2021. To move forward, there are two major challenges to address:

1. For many organizations, Covid-19 forced them to rapidly scale up telehealth programs, resulting in a patchwork of point solutions that are insufficient for integrating telehealth across the care continuum. Sustained adoption depends on providing an experience that is convenient for patients and fits clinicians' workflows.
2. We also must deal with the "digital divide," meaning the potential for new technologies to exacerbate existing disparities in health care. Without proper implementation designs and policy considerations, there's a risk that the lack of broadband service and digital literacy will prevent telehealth's value from extending to the populations that would benefit the most from it.

Health care confronted disparities that we can no longer afford to ignore

By Karl Whitemarsh, Consultant, Care Delivery 

2020 saw a long-overdue reckoning for racial equity across most major industries. The wave of activism for racial justice in the wake of the killing of George Floyd sharpened the focus on issues of race and racism in society, a focus that went far beyond policing practices. Health care was no exception, with organizations rightfully placed under the microscope as a result of the long-standing legacy of racism in health care settings, experienced by both patients and staff alike.

Amidst this context, Covid-19 shined a harsh spotlight on persistent health disparities, many of which were present long before the pandemic's arrival. As demographic data for Covid-19 cases became available earlier this year, a troublingly consistent trend emerged, with different manifestations seen around the world. Non-dominant racial and ethnic groups experience higher positivity, hospitalization, and mortality rates than the general population. In the United States, communities with lower socio-economic status—for whom access to preventive health care, social distancing, and telework options are more difficult—have been hit particularly hard. Especially historically marginalized identity groups, like Black and Latino communities.

As we look to 2021, the mandate is clear: Health system leaders must elevate health equity to a true organizational priority; on par with staff engagement, clinical quality, and financial stability.  

Health care leaders at all levels, but especially the C-suite, need to take an honest look inward and assess how their organization has managed, or failed, to make equity a priority to date. Consider the following dimensions required to achieve this (and use this tool to assess your current level of maturity on each dimension:

• Governance: To what extent do we have a leadership structure to set organizational health equity strategy?

• Social needs and community outreach: To what extent are we addressing community-wide social determinants of health and their root causes?

• Data collection: To what extent do we collect quantitative and qualitative patient data to improve care and support identification of disparities at the population level?

• Data analysis: To what extent do we analyze our data to identify health disparities in our patient population?

• Goals: To what extent do we set measurable goals for reducing disparities?

• Staff knowledge, skills, and attitude: To what extent do we provide comprehensive skill-building training for our staff?

• Culturally sensitive care delivery: To what extent are we providing culturally sensitive care to every patient who enters our system?

• Workforce diversity, equity and inclusion: To what extent do we employ people from our community and build a workforce and organizational culture that reflects our patient population?

Perhaps for the first time, health care leaders are opening their eyes to how the industry has perpetuated inequality and are actively working to undo this. To be inclusive employers, and leaders in reducing disparities in order to achieve a more equitable system.

Systemness is front and center as hospitals rethink bed capacity

By Rob Lazerow, Managing Director, Executive Insights

From my perspective working with hospital and health system executives, the story of the year is the shortage of hospital beds—and ICU beds in particular—that the nation is experiencing in the latest wave of the Covid-19 pandemic.

Covid-19 first emerged regionally, and hospitals that were pushed to the brink could often call on those in less hard-hit areas for staffing and equipment support. But this latest wave is affecting most of the country at once. And as 2020 ends, we can now quantify just how little of our inpatient capacity remains open.

According to a New York Times analysis of data that HHS released in early December, more than a third of Americans now live in areas where fewer than 15% of ICU beds are available. Roughly 10% of Americans live in areas where ICU beds are either completely or nearly full. And this is poised to worsen as we set new records for both single-day and 7-day average hospital admissions. These statistics are daunting, and I hope leaders have seen our latest collection of resources for withstanding a surge of Covid cases.  

While the current wave is our most challenging one yet, we've seen hospitals and health systems across the country rise to the challenge this past year. As we head into 2021, there are three takeaways leaders should internalize moving forward:

1. We've witnessed unprecedented systemness within organizations and cooperation across them. Hospital and health system leaders, physicians, nurses, and an army of other frontline health care heroes worked together tirelessly to expand and protect capacity. Leadership teams made rapid, enterprise-wide decisions. They pivoted quickly to pause elective procedures, repurpose space, stand up virtual and home-based care models, and flex staff and supplies across systems and even states. I sincerely hope this commitment to systemness and collaboration remains after the pandemic abates.

    

2. We were fortunate to enter the pandemic with extra bed capacity. Prior to the pandemic, we had plenty of conversations about the challenge of maintaining excess hospital beds. As of 2017, average occupancy was roughly 64%, well below most other industrialized nations. As it turned out, those lower occupancy rates helped us avoid widespread use of field hospitals that have been constructed across the year. So far, hospitals in most areas have largely had the built-in capacity to absorb surges—and hopefully that continues in the New Year.

    

3. Beds are only one part of the capacity conversation. Even if hospitals entered 2020 with extra beds, the ability to treat patients during the pandemic requires the trifecta of beds, clinicians, and personal protective equipment (PPE). Although access to PPE has largely stabilized, finding sufficient clinical staff—especially nurses, doctors, and respiratory therapists—has become a critical challenge.

One thing is clear, 2020 has fundamentally changed the conversation around hospital capacity in the United States.We’ll need to ensure our health system can flex capacity to meet future surges, and hopefully we’ll have greater tolerance—even appreciation—for some slack in the system.

A new era of site-of-care shifts

By Shay Pratt, Vice President, Research and Megan Director, Expert Partner, Research

Site of care shifts are not new, and yet each year it feels like there is a different reason why this topic should top the list of stories for the year. For some time, the narrative was around technology and treatment innovations allowing for less invasive procedures and shorter lengths of stay. In recent years, however, purchasers have largely driven this shift through tactics like site-neutral payments and steerage, recognizing the huge cost savings opportunities of outpatient and ambulatory care.

With this backdrop, coming into 2020 we thought the biggest story of the year for site-of-care shifts would be the new addition of PCI to the ASC covered procedure list. The groundwork for shifting care off the hospital campus and even to patients' homes was theoretically there, but the urgency was not.

The pandemic made our assumptions look quaint in retrospect. With the onset of the pandemic and widespread shutdowns, the abrupt changes to health care utilization was unprecedented (we hesitate to say unprecedented, but honestly, we can't remember another time like this). This involved everything from a weeks-long shutdown of scheduled and elective procedures across the country to preserve PPE to a massive upswing in virtual care and the sudden realization that many health care services could actually be provided at home.

Once we gave the green light to elective services again, we entered phase 2 of the volume shift. Yet this phase in no way resembled a return to pre-pandemic care. In fact, this is where site-of-care shifts became an even more powerful—and strategic—tool to offer care to patients safely and efficiently. Organizations worked with amazing creativity to figure out how to bring patients back for necessary care while avoiding exposure, much of which involved off-site options.

Across the pandemic thus far, providers have had to figure out how to deliver care to all the patients with "expected" conditions alongside patients with Covid-19—and they have. This is a major accomplishment for hospitals, health systems, and the entire ecosystem that should not be understated or forgotten.

But now it's time for phase 3: determining what the future landscape should look like in where care will be delivered. This is one of our big tests for 2021, as our experiences this year have opened up more options, adding complexity as well as opportunity. There are a handful of site-of-care shifts to think through:

• Inpatient care shifting to hospital outpatient care: Of course, this has been underway for over ten years. But what gets lost is that payers, particularly Medicare, continued to enact policies and changes that further encourage outpatient shift during the pandemic, such as elimination of the inpatient only list.

• Hospital outpatient care to freestanding sites: The pandemic taught patients and payers the valuable flexibility of ASCs and other off-campus sites for patient convenience and cost savings. While payers may have rested on primarily a cost argument when trying to shift services to ASCs in the past, they now have a safety, capacity, and access argument as well.

• Inpatient, outpatient, and post-acute care to the home setting: The pandemic has also opened our eyes to the full range of services that could potentially shift to home, spanning the care continuum. We have heard a growing interest in hospital-at-home, SNF-at-home, physical therapy-at-home, and home infusion models in recent months, which are likely to have staying power beyond the public health emergency.

• The shift to virtual care: This is one of the most significant evolutions we’ll face in 2021. Leaders from across the organization will need to partner to answer critical questions like what services should be done virtually, how do we effectively embed these into provider workflows and patient care, and what will the reimbursement landscape look like.

As we look ahead to 2021, site-of-care shifts are no longer just a factor of technological innovation and payer pressure. Providing care in the most appropriate and accessible location has become a demand across the industry. From patients wanting lower-cost, more accessible, and safe care options. From physicians who want the same for their patients and have recognized the utility of virtual or home care when integrated properly. From the entire industry, which has recognized that we can do this—we just did this under enormous pressure and little time to prepare. So, 2021 is where the rubber hits the road.

The health care "heroes"

By Rachel Woods, Expert Partner, Executive Insights and Anne Herleth, Senior Consultant, Clinical Best Practice Collaborative

It's impossible to reflect on 2020 without acknowledging the incredible resilience of the clinical workforce—one that has been sprinting a marathon for 10+ months.

Covid-19 put unprecedented strain on the clinical workforce in both hours worked and emotional well-being. Physicians and nurses showed incredible flexibility, providing care whenever, wherever, and however it was needed. And they often did this under less than ideal conditions. Beyond the Covid-19 frontlines, staff pivoted again and again to adopt new safety protocols or technological innovations, or dealt with uncertainty while sidelined by cancelled electives. The bottom line is: the entire workforce has been under more stress this year than perhaps ever before.

And the consequences of this year will impact the workforce in 2021 and beyond. We're seeing higher rates of burnout, trauma, and PTSD than we've ever seen before. Whether it stems from anxiety and fear around personal safety to ethical issues and moral distress. Not to mention the impact of Covid-19 care itself, and the toll of watching patients and colleagues die virtually alone, with clinicians being the only hand to hold.

Beyond the emotional toll, we'll continue to see clinicians leave their profession. Many left the workforce entirely due to the childcare crisis. Some have been pushed into early retirement, and others are switching roles due to safety concerns or the very reasonable need to maximize income in a struggling economy. Some gave their lives to this fight. That's left most organizations to function on crisis staffing—oftentimes without enough nurses or enough expertise to cover patient demand. That marathon we mentioned? Now imagine running in the pouring, freezing rain—barely able to move your feet fast enough.

For us, the story of 2020 will always be the story of nurses with bruises on their faces from wearing PPE all day. It will always be the story of doctors holding a dying patient's hand while wearing enough protective equipment to look like they came out of a sci-fi thriller. It's a story of suffering and of hope, but more than anything it's a story about grit. Because day in and day out, the frontline continues show up and take care of us. And with a fight that isn't over, they will continue to do that in 2021, and beyond. 

The Affordable Care Act goes to the Supreme Court (again)

By Yulan Egan, Practice Manager, Executive Insights

Ten years after the passage of the Affordable Care Act—and eight years after the ACA was (mostly) upheld in a landmark Supreme Court ruling—the law once again found its way before the highest court in the nation in 2020.

Since the case's inception in 2018, legal experts on both sides of the aisle have agreed that the plaintiffs' argument in California v. Texas is no slam dunk—and that a full invalidation of the ACA is extremely unlikely. However, the passing of Justice Ruth Bader Ginsberg in September introduced new uncertainty into the outlook for the case, and undoubtedly reshaped the final weeks of the presidential election.

The ACA was once again elevated as a central issue in an election that had become laser focused on the Covid-19 pandemic. In many ways, the uncertainty surrounding the future of the ACA allowed both President Trump and (now) President-elect Biden to return to their pre-pandemic platforms. Biden pivoted his campaign to focus heavily on protection for—and expansion of—the ACA, while Trump doubled down on the need to replace the law. While it is impossible to quantify the precise impact the ACA had on the outcome of the election, it is likely that health care was one of the top issues on voters' minds as they cast their votes.

After listening to oral arguments, which followed closely on the heels of the election, most legal experts continue to believe that full invalidation of the law remains unlikely. That said, Biden's nomination of California Attorney General Xavier Becerra—who has led the defense of the case before the Supreme Court—to the position of HHS secretary is a clear signal that the law will continue to a major issue in 2021 and beyond. And there is little doubt that President Trump has made an enduring impact on the nation’s judicial system by shifting political leanings of the Supreme Court. While this shift may not impact the outcome of California v. Texas or the future of the ACA, we will likely see its impact on other health care cases in the future. 

The health care supply chain fell short

By Nick Hula, Analyst, Life Sciences and Ecosystem Research

You know it's a crazy year when even something as typically mundane as supply chain makes national headlines for months on end. First, it was ventilator and PPE shortages, then testing supplies and Covid-19 treatment drugs. Then the cold-chain became a household term as the promise of a vaccine approached. At each turn, the pandemic quickly revealed weaknesses in the health care supply chain, and the media was quick to pounce on the failures.

As we began this research endeavor, we quickly realized this collapse was inevitable. Similar to other sectors, health care supply chains are designed for efficiency, relying on common business practices like ""just-in-time"" and ""sole-sourcing."" Together, these practices created an inflexible system unable to withstand shocks and quickly ramp up production or distribution.

But the problems go much deeper. The underlying shortcoming—and what doesn't nearly get as much press coverage—is the lack of transparency into and across the supply chain. At every step of the process, trading partners are unsure of their upstream suppliers' quantity and sourcing practices. So, the pandemic created an unforeseen shortfall of critical supplies and equipment. All the while, many health systems don't know what they already have, how much they need, or where to find more. 

With those explanations in mind, what did we learn from all of this? Contrary to its intended design, the health care supply chain isn't all that efficient. We frequently heard stories of incredible waste—organizations that didn't know how many ventilators they had or where they were located, or clinicians that kept secret stashes of PPE in the ceiling tiles. But ironically, this revelation was promising. It invalidated the false dichotomy that resiliency and efficiency always come at the other's expense. We found that by increasing visibility across the supply chain, organizations can unlock opportunities to reduce waste and increase flexibility at the same time. This could be recognizing how better demand planning can reduce overnight shipping needs or how better inventory management can help avoid buying too much capital equipment.

The health care supply chain mandate to improve transparency in coming years is a tough one, but it's full of smart people, energized to tackle a common goal—and that's a good thing.

FDA evaluated a flurry of old and new therapies to treat Covid-19

By Manasi Kapoor, Senior Director, Life Sciences and Ecosystem Research

Since the beginning of the pandemic, providers grappled with efficiently finding effective treatments for Covid patients given limited information and resources. Researchers, scientist, and providers quickly mobilized to test both new and existing therapies against Covid-19—with mixed success.

For example, FDA approved one treatment and issued several Emergency Use Authorizations (EUAs) for other drugs. In October, FDA approved remdesivir—the first (and only) drug approved to treat certain patients hospitalized with Covid-19. The FDA also issued EUAs for treatments based on early data that suggest safety and effectiveness. For instance, FDA issued EUAs for two new monoclonal antibodies from Eli Lilly and Regeneron. FDA also continued to evaluate these therapies and quickly pivoted as new guidance and data came out—as was the case with hydroxychloroquine.

Although we have yet to identify a silver-bullet treatment for Covid-19, we are now better positioned to treat Covid-19 patients than we were in March.

But our progress here is not just about the clinical interventions—it's also about how we came together as a medical and clinical community to rapidly evaluate therapies, incorporate new technologies and innovations, and share data in the hopes of finding something that worked. Here are a few things that stood out to me from this year and our efforts to identify Covid-19 therapies:

• Collaboration and data sharing to streamline clinical research and identify new therapeutic interventions. For example, the NIH partnered with 16 drug companies to coordinate, standardize, and accelerate their research on Covid-19 therapies and vaccines. We also saw large scale, international trials come to fruition to evaluate clinical interventions quickly and reliably.
• Cooperation to ensure equitable access to Covid-19 treatments globally. 18 big generic drug makers have pledged to work with a leading non-profit organization to accelerate access to Covid-19 treatments for low- and middle-income countries.

• Clinical trial re-design to rapidly evaluate effectiveness of Covid-19 therapies. Amgen and the Japanese pharmaceutical company Eisai will become the first pharma companies to test their experimental therapies in REMAP-CAP, an adaptive clinical trial that seeks to rapidly evaluate potential Covid-19 treatments using real-world evidence.

• Pharmacogenomics testing to identify targeted treatments for Covid-19. Throughout the epidemic, researchers have leveraged genomic data to understand how the virus affects different people and to identify targeted treatments accordingly. The Covid-19 Host Genetics Initiative is one forum where researchers and providers around the world can share data and insights about the relationship between genetics and Covid-19 treatments. 

New regulation seeks to end information blocking

By Ye Hoffman, Consultant, Health Care IT Advisor and Quality Reporting Roundtable, and Julia Connell, Consultant, Quality Reporting Roundtable

Just as the first wave of Covid-19 cases spiked, the Office of the National Coordinator for Health IT (ONC) released a new regulation aimed at fostering interoperability and sharing of electronic health information. The rule impacts many of the major stakeholders in health care, including providers, IT developers, and entities that provide health information exchange services. But the immediate challenges posed by Covid-19 understandably shifted resources for those who would have otherwise been focused on these rules. In response, ONC extended the timelines to comply from November 2, 2020 to April 5, 2021.

The information blocking regulations will change health care in three major ways:

• Signals a significant push toward unlocking patients' access to and ownership of their electronic health information

• Fosters health IT innovation through expanded sharing data via standards-based application programming interfaces (APIs)  

• Shifts providers' approach to data sharing policies by narrowly defining scenarios where it's appropriate to withhold patient information

Providers need to develop internal compliance policies, communicate new guidelines to frontline clinicians and staff, and revisit their approach over time. Our experts and research can help each step of the way.