This workgroup is focused on developing the structure that our proposed privacy framework for unregulated health data will take. On our March call, the group voiced general support for moving ahead with a self-regulatory model of some kind, and therefore our April call focused on walking through a number of different self-regulatory structures.

The goal of this workgroup is to develop the content of a framework for unregulated health information. The April meetings focused on specific protections that should apply to covered data. Our upcoming meetings on May 18 and 20 will focus on exceptions to those protections. During the April meetings, the workgroup discussed on how baseline collection, use, and sharing limits of consumer health data should be addressed under the framework. There was also discussion regarding the definition developed during the March meetings. 

Dr. Michael Berlowitz, Chief of Cardiovascular Operations at the University of South Florida and Jacqueline Tomei, Quality Programs Manager, American Heart Association discuss the use of virtual care, SDOH, and data analytics to deliver care for patients with cardiovascular disease, and the rapid changes made to respond to COVID-19.

Background: Through Congressional action, the Secretary of Health and Human Services (HHS) was granted the authority to waive underlying statutory restrictions on Medicare reimbursement of telehealth services during the COVID-19 public health emergency period. The Centers for Medicare and Medicaid Services (CMS) has implemented this flexibility through the issuance of waivers, as well as an interim final rule. 

As health care facilities and provider practices look to protect their providers and patients from COVID-19, telehealth provides a safe and effective option for providers to continue to treat patients from a distance. eHI has put together this FAQ document to help those who are implementing telehealth during this period.*  

Coronavirus Testing Capacity Is Going Unused

Many U.S. labs say they can process far more tests than doctors, hospitals have ordered. 

By Brianna Abbott and  Sarah Krouse

April 29, 2020 

Many commercial and academic laboratories in the U.S. are processing coronavirus diagnostic tests far below their daily capacity, leaving tools crucial to slowing the virus’s spread unused.

Some labs across the country say they are processing less than a quarter of the diagnostic tests for Covid-19, the illness caused by the new coronavirus, they are equipped to manage. Lab executives and public-health officials blame barriers including fragmented supply chains, relatively strict test guidelines, incompatible electronic systems and a lack of centralized data on where capacity exists.

The result is a disorganized system that isn’t matching the limited testing supply with the demand, and some public-health experts are calling for national coordination to scale up quickly.

Most tests to diagnose Covid-19 involve taking a nasopharyngeal swab to collect the patient sample and then running the polymerase chain reaction, or PCR, test in a laboratory. As testing becomes one of the most hotly debated topics during the coronavirus crisis, WSJ’s Gerald F. Seib explores what role pharmacists will play in diagnosing patients. 

“We have university laboratories around this country that have the ability to run 1,000 or 3,000 tests per day, yet many of them are nowhere near capacity,” said Michael Pellini, managing partner of venture fund Section 32 and a contributor to the Rockefeller Foundation’s national Covid-19 testing action plan. “We need to make sure they’re utilized.”

Members of the American Clinical Laboratory Association, which include testing giants Quest Diagnostics and LabCorp, also aren’t receiving test orders in numbers to match their full capacity, said Julie Khani, ACLA’s president. The companies, some of which previously had backlogs of several days following an initial flood of orders, now are contacting physicians to let them know they have unused resources.

Covid-19 test access varies widely across the country, with some sites making tests available only to patients with severe symptoms and to front-line health and public-safety workers. Other sites offer tests to people with mild symptoms and all essential workers.

On Monday, the Centers for Disease Control and Prevention broadened its priority for testing, adding symptomatic first responders and people in longterm-care facilities, prisons and shelters to the top tier. The priority list for the first time includes people without symptoms, at a clinician or public-health authority’s discretion, though they aren’t the highest priority.

Many companies say widespread worker testing is part of their return-to-work plans.

Last week, the Trump administration provided governors with lists of sites with unused testing capacity. States, cities and organizations have started coordinating to expand and work through the logistical barriers.

Labs across the U.S. processed just over 1.5 million Covid-19 diagnostic tests within the past week, according to the Covid Tracking Project. But public-health authorities say the country is still far behind where it needs to be to test suspected cases, isolate them and trace their close contacts—all necessary to ease out of lockdowns safely.

With the full potential of U.S. hospital, commercial and academic labs unlocked, testing could scale from roughly 1.5 million to 3 million weekly tests within eight weeks, says Rajiv Shah, president of the Rockefeller Foundation.

But then jumping to 30 million weekly tests—the next phase in the foundation’s plan—would likely require new tech, such as quality rapid tests and at-home testing, he said. The Defense Production Act would also likely need to be invoked, according to the foundation’s report.

Limited access to basic supplies, such as swabs and chemical reagents, has plagued labs across the country for weeks, and these supply-chain issues persist. But obstacles to scaled-up testing go further to include other logistical barriers and lack of doctor and patient awareness of what’s available. Some facilities fear that if they use up their testing supply too fast, they won’t be able to get more, lab-testing officials and hospital workers say.

There is currently no centralized nationwide database of testing availability for doctors to consult before sending patients for tests.

San Francisco’s Department of Public Health has the ability to process 4,300 diagnostic tests a day at three labs it works with, said Susan Philip, director of infectious-disease prevention and control at the agency. On average, only 500 tests a day are completed for city residents at those labs and others.

The reason for the gap could be that initial guidance was to restrict access to tests and has since evolved, Dr. Philip said. The city aims to use 80% to 90% of its capacity, she said, and last week announced it would expand testing for all private-sector, public and nonprofit essential workers and symptomatic residents who couldn’t get tested elsewhere.

The Michigan Department of Health and Human Services last week sent out an alert telling doctors there is unused capacity throughout the state.

NxGen MDx, a laboratory in Grand Rapids, Mich., is processing about 25% of the 7,000 coronavirus diagnostic tests it can handle a day. “The key thing now is getting the word out that the net is wider,” said Doug McIntosh, senior director of marketing.

Part of the challenge in making full use of testing capacity is the “deep fracturing of the system,” with little coordination between doctors, patients, labs and insurers, said Othman Laraki, chief executive at Color, which conducts coronavirus tests.

Most health systems have contracts with specific labs and sometimes don’t stray from them, and some insurers won’t pay reimbursement for outside labs, Dr. Pellini of the Section 32 fund said. He adds, however, that such problems are being addressed for Covid-19. Smaller labs often don’t have the purchasing power or electronic infrastructure in place to come online easily; those that do sometimes don’t have compatible systems, he said.

The University of California, San Francisco, announced Friday it would offer free test results to all 58 county public-health departments in California after setting up a new diagnostic lab. One of the biggest challenges now is the logistics of getting patient samples and information to the lab and then sending the results where they need to go, says Steve Miller, professor of laboratory medicine at UCSF.

To communicate results with some of the incompatible systems outside of the hospital, the lab faxes them. “As you can imagine, that is not a very scalable thing,” Dr. Miller said.

Unused capacity could be put to work in high-risk places like assisted-living facilities, where understanding who is sick helps inform housing and staffing choices, said David Dexter, chief executive of Sonora Quest Laboratories, in Arizona. Many facilities still don’t have easy access to testing.

Researchers have suggested that infected nursing-home staff who are asymptomatic are a likely source of infections in the facilities, which have tallied thousands of deaths from Covid-19. They have found that separating infected residents from others is difficult when many don’t show typical signs of the illness and thus don’t get tested.

The organization Mr. Dexter leads is using only 20% of its PCR test capacity, “which I think is a travesty,” he said.

Many commercial and academic laboratories in the U.S. are processing coronavirus diagnostic tests far below their daily capacity, leaving tools crucial to slowing the virus’s spread unused.

Some labs across the country say they are processing less than a quarter of the diagnostic tests for Covid-19, the illness caused by the new coronavirus, they are equipped to manage. Lab executives and public-health officials blame barriers including fragmented supply chains, relatively strict test guidelines, incompatible electronic systems and a lack of centralized data on where capacity exists.

Download full article below. 

Adverse health effects of the opioid epidemic continue to climb. Opioid-related overdose deaths reached an all-time high of 42,249 in 2016,¹ prompting President Trump to declare an opioid public health emergency in 2017. From July 2016 to September 2017, emergency department visits associated with opioid-related overdoses spiked about 30%.² Those with opioid use disorders (OUDs) face dramatically increased risk of early death, typically from overdose. Provision of evidence-based medication-assisted treatment (MAT), which can involve methadone, buprenorphine, or naltrexone, to those with OUDs has been shown to reduce the risk of death by as much as 50%.³ Yet access to MAT remains severely inadequate—notably in rural America, particularly hard hit by the epidemic. Policymakers generally agree that more widespread access to MAT is desperately needed; the question remains: how?

Prominent among strategies proposed to ramp-up MAT access is providing it via telemedicine. Telemedicine, or the remote delivery of health care using telecommunications technology, has the potential to increase access to MAT medicines and concurrent therapy in underserved, remote rural areas by providing direct-to-patient or specialty consultation services from afar. Although telemedicine to treat patients with OUDs has been piloted favorably, scaling up its provision is not as simple as connecting a patient to a provider. Rather, stakeholders must surmount considerable regulatory, logistical, and quality hurdles before telemedicine can help to mitigate the opioid epidemic.

Read more of this perspective from the Mayo Clinic below.

Our COVID-19 Federal Policy Work Group series to help craft a report with a set of recommendations to fully leverage health IT and digital health to fight COVID-19 and future public health challenges. This meeting will focused on artificial intelligence and machine learning. 

Our guest speaker was Eileen Koski, Program Director, Health Data and Insights, Center for Computational Health, IBM Research who will discuss how IBM has deployed AI in the fight against COVID-19. 

Privacy in the Time of Coronavirus

In the presence of COVID-19, the balance inherent in health information access has taken on an additional dimension: individual privacy v. public health needs. This ultimately begs the question: does patient privacy retain its importance in the time of a national health emergency?

Many in the general public are unaware that HIPAA already allows for certain disclosures of protected health information for public health purposes, even when the circumstances don’t constitute a pandemic or crisis. But in the wake of COVID-19, a number of additional adjustments to HIPAA and its enforcement have been enacted by the Office for Civil Rights (OCR) over the last couple of months, including:

• Waiving a number of sanctions and penalties applicable to hospitals, including requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care.
• A suspension in the imposition of penalties against covered health care providers for non-compliance with the HIPAA Rules in connection with the good faith provision of telehealth services, including telehealth services unrelated to COVID-19.
• Allowances for new types of testing sites that ordinarily would violate HIPAA. OCR has issued a notice of enforcement discretion for covered entities and their business associates who participate in community-based testing sites, which include mobile, drive-through, or walk-up sites that provide only COVID-19 specimen collection or testing services to the public.

Should We Worry About Relaxation of Rules?

These measures have generally been well-received, but the urgency to collect and analyze data generated by patients outside of a hospital or physician’s office (such as cell phone location data) on a massive scale to track the spread of the virus – known as “contact tracing” – has increased the amount of individual and health data being held by entities not covered by HIPAA.

This vast trove of individual data, combined with reduced legal protections, has also led to worry about how that data may be used, and by whom – both now, during the immediate crisis, and down the line, once the crisis has passed. Given the lack of federal and state legal protections for some of the COVID-19-related surveillance information being collected by, for example, Facebook, Apple and Google (not to mention a host of other apps), privacy practices and data use policies are mostly left up to corporate and institutional best practices and terms of use.

Even before COVID-19 effectively shut down the U.S. economy and became the focus of the majority of legislative efforts on Capitol Hill, momentum had been building for a new comprehensive federal privacy law governing personal data, including health data. As the aforementioned tech giants have announced their COVID-19-tracking efforts to great fanfare, privacy advocates have reignited their calls for such efforts to exist within clear and perhaps increased protections.

Many have been vocal that privacy protections and worries should take a back seat in times of national crises – that the suspension of some civil liberties is justified by the need to respond to a crisis in which scores are dying, and millions have lost their jobs. Supporters of this perspective believe that whatever policy adjustments are necessary to stem the spread of the virus, get people back to work, children back to school, and the economy reopened are worth it.  On the other side of the debate are those who make the analogy to the time after 9/11, when increased domestic surveillance efforts proved to be both widely unpopular and hard to roll back once the immediate aftermath had passed. Reducing civil liberties may be a short-term fix, but it can prove to be a dangerously slippery slope.

Given the severity and urgency of this particular public health emergency, it does seem prudent that the always-dynamic privacy balance should shift toward the “whatever it takes to address the crisis” end of the spectrum. But how aggressively should we tilt, under what conditions, and for how long?  

Some basic considerations have been put forward by a number of experts and scholars, including by a couple of members of the Privacy and Civil Liberties Oversight Board, established by the 9/11 Commission, the body that conducted the definitive investigation of the 9/11 terrorist attacks. In an op-ed in Politico, the authors considered how we can “defeat the epidemic while preserving our privacy, liberty, and way of life.” Their recommendations include balancing risk vs. benefits; establishing clear rules for how data can be collected and used, retained and shared; establishing how long any measures enacted in this time of crisis should remain in place; and prioritizing transparency in all efforts. 

We agree with these guidelines and principles, but we also realize that our national response to this debate will be, as with so many others, some mix of reactionary and proactive. The fact remains that there are no national privacy laws preventing technology-enabled contact tracing, and with state and federal governments desperately looking for quick solutions to reopen their economies, it is an unlikely environment for federal consensus privacy legislation. Even the European Union, which has stringent and far-reaching data protections, is seeing its laws tested by coronavirus response efforts.

However, the more that privacy is publicly discussed, the more accountable the government and commercial companies with which it is collaborating will be. Continued evaluation, both of the virus-response measures and their evolving value, is crucial, and eHI looks forward to engaging its members in these efforts.

Alice Leiter​​
Vice President and Senior Counsel, eHI

The LexisNexis Risk Solution data and analytics team designed the COVID-19 data set by combining proprietary data assets and models from LexisNexis Health Care with data from the Johns Hopkins University Center for Systems Science and Engineering, which includes data from WHO, CDC, and other independent sources, and data from the American Hospital Association (AHA).

The COVID-19 Data Resource Center features heat maps with insights that identify at-risk populations and correlated gaps in provider coverage. Each county is assigned a percentile rank on a scale of 0 (low-risk) to 100 (high-risk) across various parameters. The map is updated regularly to quickly address the care needs of the community.