What a Month!

For the past two weeks I, and many others, have been reviewing and preparing presentations on the finalized and long (very long) awaited CMS and ONC interoperability regulations. For the past two weeks I, and millions of others, have also been dealing with the existential and practical implications of the COVID-19 pandemic. What a month, and it is not over.

I’ve been planning on blogging on these rules for months and here we are. I’m glad that I have waited a couple of weeks to write this, to be able to reflect on what I have read and learned from colleagues.

So first, on March 9, both ONC and CMS released (but have not yet formally published in the Federal Register) these two major regulations. This blog will focus on the ONC rule.

I’m obsessed with the need for better and more nuanced health policy making. And with this rule from ONC and several actions by HHS in response to the pandemic, we see excellent examples of how to do policy better.

For COVID-19, I’ll point to some of the rapid and powerful HHS actions on telehealth. At Secretary Azar’s direction, CMS has relaxed long standing payment restrictions, allowing more clinicians to provide telehealth services to more patients. And powerfully, the HHS Office of Civil Rights (OCR) announced enforcement discretion for HIPAA privacy and security constraints on telehealth services, such as remote audio or video services for patients.

I ‘ve seen firsthand how rapidly these simple changes have transformed care delivery. For example, my wife, a clinical psychologist, is now providing remote psychotherapy from our home, increasing the safety of her patients, her colleagues, and herself. The OCR announcement was last Tuesday, she and her department chair made the decision the next day, and she “saw” her first remote patients Friday. Fast!

This kind of change is the classic pareto opportunity, grasping the small lever (the 20%) that moves the world 80% of where it needs to go. It is a simple policy change that can be rapidly understood and acted on by health care organizations and administrators, by clinicians, and by patients, with no need for webinars, seminars, lawyers, consultants, or expensive new technology. Facetime and Zoom, along with laptops, tablets and smart phones, are more than up to the task.

Now, to the ONC final rule. First, ONC emphasizes its continuing commitment to the goals of this rule:

It has been three years since the Cures Act was enacted and information blocking remains a serious concern. This final rule includes provisions that will address information blocking and cannot be further delayed.

We have taken multiple actions to address some expressed concerns regarding the timing of the Conditions and Maintenance of Certification requirements as well as the comprehensiveness of the information blocking proposals.

We continue to receive complaints and reports alleging information blocking from a wide range of stakeholders.

Second, ONC made many changes in response to comments. As someone who helped develop several comments that they received, I was struck by the degree to which the ONC rule writers called out comments with a high level of completeness and specificity, responded thoughtfully and in detail, and made important changes reflecting the central themes of these comments. Overall, my senses is that ONC, from its most senior levels on down, took very seriously the need to address comments and to reduce identified challenges and burdens; certainly not to zero but still, to a significant degree.

What were some of the major changes and their implications?

• ONC pushed out some compliance deadlines:
  
  • Compliance for information blocking provisions is now 6 months after Final Rule publication and only after a companion rule on civil monetary penalty (CMP) enforcement is finalized by the HHS Office of the Inspector General (OIG);
  • Most Conditions of Certification take effect six months after publication; and
  • EHR export capability is moved out to 36 months after publication.
• ONC simplified the definition of the interoperability elements that are the subject of potential information blocking.
• ONC made a small revision to the definition of developer of certified health IT, excluding providers who self-develop for their own use from being defined as a developer for purposes of information blocking enforcement.
• Notably, ONC combined and narrowed the HIE and HIN actor categories, creating one category and clarifying that the definition does not unintentionally cover “essentially bilateral exchanges” in which an intermediary is performing a service on behalf of one entity in providing EHI to one or more entities and no “actual exchange” among all entities; it notes that this narrower definition should “clearly exclude entities that might have been included under proposed definitions (e.g., social networks, ISPs, and technology that solely facilitates exchange of information among patients and family members) and in public discussion, excludes traditional claims clearinghouses functions.
• ONC substantially narrowed the definition of Electronic Health Information (EHII), defined it as the finalized US Core Data for Interoperability (USCDI) v. 1 data elements for the first 24 months after rule publication and then as electric Protected Health Information (HIPAA ePHI) in a (HIPAA) Designated Record Set.
• ONC retained the general definition of information blocking practices and did not change the many examples of such practices from the proposed rule, while adding some additional focused examples, responding to comments.
• ONC finalized the USCDI largely as proposed, with a few revisions and an implementation period for certification of 24 months after rule publication.
• ONC simplified the definitions of EHI access, exchange, and use, while retaining the intent from the proposed rule (e.g., “write” access remains part of “use” even if it is not part of the finalized API certification criteria).
• ONC significantly revised the “reasonable and necessary exceptions”:
  
  • Revising titles and simplifying and clarifying text;
  • Establishing a new Content and Manner exception that draws from or refines aspects of the Infeasibility, Fee, and Licensing exceptions, with a provision that fees and licensing terms mutually agreed to when an actor handles a request for EHI in the “manner requested” can reflect “market rates” and need not use or meet the Fee or Licensing exceptions (this latter change is huge and responds to many comments on the complexity and burden of the proposed fee and licensing exceptions); and
  • Removing the confusing RAND licensing model in the Licensing exception.
• For health IT certification, ONC made several final policy decisions:
  
  • Maintained use of the 2015 edition ONC certification criteria, with limited modifications;
  • Eliminated several criteria, mostly as had been proposed, because they are already well implemented in EHRs or included in the new USCDI;
  • Revised several referenced standards (e.g., specifying use of HL7® FHIR® 4.01)
  • Revised the API certification criteria; and
  • Specified that timing for some Conditions of Certification is 60 days after publication, with most at 6 months after publication

So, what should “actors” be doing as we wait for the Final Rule to be published (which could be delayed as the Administration grapples with the COVID-19 pandemic) and the various implementation periods to be completed? And, we need to consider the challenges being wrought by the pandemic, especially on provider organizations but truly, across our nation. The answer can be found by reflecting on Congress’s reasons for enacting the Cures provisions, by ONC’s intent and priority regulatory themes, and by common sense.

First, organizations that are actors or exchange data with actors, or who want to do so, should move now to set implementation and compliance plans in motion and to designate executive sponsorship for their information blocking and API efforts. Again, reality intrudes and the pandemic must be the highest priority but this rule is unlikely to go away and its focus on increased data access could help in combatting COVID-19.

Second, actors should focus sequentially and seriously on the big questions raised by the information blocking and API provisions:

• Is my organization an actor or even multiple actors?
• What interoperability elements and types of EHI do we control?
• How are these elements deployed to support current or likely requests for access, exchange or use?
• What activities do we engage in that could be considered information blocking practices?
• What exceptions will apply or be needed?
• How do we handle client and stakeholder requests for access, exchange, and use and to what extent can we reach mutually agreeable resolution of any issues, now?
• How can my organization benefit from increased data liquidity and what are the ways the I can better meet the needs of my key stakeholders who seek such liquidity?
• How can I assess and ensure that our policies for data access, exchange, and use are perceived as fair, non-discriminatory, and consistent with the spirit (and the letter) of the final policy and the eight exceptions?

You now know what ONC and the broader community are looking for. You can also expect, given the profound changes to our world from COVID-19 (and advocate for) enforcement focused on the most egregious violations. Yes, detailed compliance will matter, but for now, simply try to do, and prepare to do, the right thing. That approach will lead to satisfied stakeholders, lower compliance costs, and a more proportional response to these rules considering the massive challenges that our providers and nation are facing.

Be well.

Mark Segal, PhD, FHIMSS, Principal, Digital Health Policy Advisors, LLC. Member and Past Chair of the eHI Policy Steering Committee. March 23, 2020. Twitter @msegal111

eHI thinks Mark Segal is a super cool guy and is providing his opinions for informational purposes only. The opinions presented, do not represent those of eHealth Initiative, our members or the Foundation.

Health workers fear U.S. hospitals will become coronavirus hot spots

Doctors and nurses are increasingly worried they will become the spreaders of the coronavirus rather than the healers, as hospitals themselves become a hot spot for the pandemic.

That fear is already a reality in Italy, the global epicenter of the pandemic, where researchers have found hospitals overloaded by COVID-19 patients have become transmission points. Public health officials, like those at the World Health Organization, have increasingly warned that health care workers themselves could be vectors for the disease — accelerating its spread and undermining the ability of countries’ health systems to combat it.

The full Politico article can be viewed at this link.  

The Toughest Triage — Allocating Ventilators in a Pandemic

The COVID-19 pandemic has led to severe shortages of many essential goods and services, from hand sanitizers and N-95 masks to ICU beds and ventilators. Although rationing is not unprecedented, never before has the American public been faced with the prospect of having to ration medical goods and services on this scale.

Of all the medical care that will have to be rationed, the most problematic will be mechanical ventilation. Several countries, but not the United States, have already experienced a shortage of ventilators. Acute care hospitals in the United States currently have about 62,000 full-function ventilators and about 98,000 basic ventilators, with an additional 8900 in the Office of the Assistant Secretary for Preparedness and Response Strategic National Stockpile. The Centers for Disease Control and Prevention estimates that 2.4 million to 21 million Americans will require hospitalization during the pandemic, and the experience in Italy has been that about 10 to 25% of hospitalized patients will require ventilation, in some cases for several weeks. On the basis of these estimates, the number of patients needing ventilation could range between 1.4 and 31 patients per ventilator. Whether it will be necessary to ration ventilators will depend on the pace of the pandemic and how many patients need ventilation at the same time, but many analysts warn that the risk is high.

The full perspective can be downloaded below.  

The US health system is at the brink of operating at above capacity and healthcare organizations need clarity on how to address COVID-19 risk within their population and their community more broadly. AI has the ability to deliver intelligence that can assist national response to COVID-19 by : giving insights into which hospitals will have similar experiences and impacts; identifying expected relative risk across geographies; surface high-risk patient populations; and provide clinicians with point-of-care clinical decision support.

Please join us while we discuss some important developments in AI with real-world examples and how providers and communities can apply them to drive optimal outcomes during times like these.​

Presentation recoding, slides, and additional resources are present at the bottom of this page. 

Speakers:

Lori Tremmel Freeman

Chief Executive Officer, NACCHO​

Lori Freeman is the Chief Executive Officer (CEO) at the National Association of County and City Health Officials (NACCHO), effective May 1, 2018. Prior to joining NACCHO, Ms. Freeman served as the CEO of the Association of Maternal & Child Health Programs (AMCHP) since 2014 where she was responsible for ensuring the success of all AMCHP’s operations. ​Ms. Freeman has developed and overseen cooperative agreements and grants with a variety of government agencies and private foundations including procuring, planning, developing and implementing annual and multiyear grant proposals. Throughout her tenure in nonprofit management, she has contributed widely in senior managerial roles in strategic planning and visioning, building relationships and partnering opportunities, membership and new business development, foundation start-up and fundraising, the creation of benefits and services, use of technology to advance organizations, event turnaround, and program management.  

John Frownfelter, MD

Chief Medical Information Officer, Jvion

John is an internist and physician executive in Health Information Technology and is currently leading Jvion’s clinical strategy. With over 15 years’ leadership experience he has a broad range of expertise in systems management, care transformation and health information systems. Dr. Frownfelter has held a number of medical and medical informatics leadership positions over nearly two decades, highlighted by his role as Chief Medical Information Officer for Inpatient services at Henry Ford Health System and Chief Medical Information Officer for UnityPoint Health where he led clinical IT strategy and launched the analytics programs. Since 2015, Dr. Frownfelter has been bringing his expertise to healthcare through health IT advising to both industry and health systems. His work with Jvion has enhanced their clinical offering and their implementation effectiveness. Dr. Frownfelter has also held professorships at St. George’s University and Wayne State schools of medicine, and the University of Detroit Mercy Physician Assistant School. Dr. Frownfelter received his MD from Wayne State University School of Medicine.

Priyanka Surio

Director of Informatics, ASTHO

Ms. Surio currently serves as the Director of Data Analytics and Public Health Informatics within ASTHO’s Center for Population Health Strategies where she manages the Informatics project portfolio across ASTHO. Projects address population health issues for state and territorial health departments and include work in data linkages, disease surveillance, data partnerships for violence prevention and electronic case reporting, and building health IT/informatics and disease surveillance capacity through strategic planning and workforce development. Ms. Surio is an accomplished leader with 7+ years of experience in healthcare systems process improvement and expertise in project management, research methods, statistical analytics, and health education and policy.

John Showalter, MD

Chief Product Officer, Jvion

Dr. Showalter brings visionary thought leadership on the application of advanced information technology to improving outcomes for patients. His unique education in biomedical engineering, physiology, clinical informatics and internal medicine has allowed him to work at the intersection of those fields to positively impact patient care and health system efficiency. His work has been recognized with cross-industry awards including ComputerWorld's Premiere 100 IT Leaders and health IT awards such as the CHIME Collaboration Award. Dr. Showalter is dedicated to using his passion and knowledge to ensure that Jvion's machine has the maximum positive impact for patients.

Keeping COVID-19 from Infecting Health-Care Workers

The message is getting out: #StayHome. In this early phase of the coronavirus pandemic, with undetected cases accelerating transmission even as testing ramps up, that is critical. But there are many people whom the country needs to keep going into work—grocery cashiers, first responders, factory workers for critical businesses. Most obviously, we need health-care workers to care for the sick, even though their jobs carry the greatest risk of exposure. How do we keep them seeing patients rather than becoming patients?

The full New Yorker article can be viewed at this link.  

Coronavirus Will Have Long-Lasting Impacts on the U.S. Health Care System—And the Poorest Will Suffer Most

The worsening coronavirus epidemic in the U.S. has upended the country’s medical system. It has led to system-wide disruptions that physicians say are necessary for combatting the immediate, un-ignorable threat of COVID-19—but that may, by default, force patients who do not have coronavirus to shoulder a heavy burden. Those with chronic conditions will have to fight harder to get the care they need, not only now but also after the outbreak ends, when hospitals are left to deal with backlogs from appointments canceled en masse. Anyone with the misfortune to get into a car accident or have a heart attack during the outbreak will be at the mercy of a strained system. And in this environment, the gulf between people who can and cannot afford to spend the time and money to seek out good care will become ever-more apparent.

The full TIME article can be viewed at this link.  

Shuttered Hospitals Re-Opening Across U.S. For Coronavirus Cases

Hospitals that only recently were closed after struggling financially are now being re-opened by state and local governments to treat the sickest of patients stricken by the Coronavirus strain COVID-19.

In the south Chicago suburb of Blue Island, Ill., for example, a hospital with more than 300 beds may re-open to treat Coronavirus patients, Chicago Mayor Lori Lightfoot said Tuesday. And in California, the Orange County Board of Supervisors said this week the state is looking at re-opening the former 73-bed Saddleback Memorial Medical Center in San Clemente while 158-bed Community Hospital in Long Beach is preparing to re-open after being closed just two years ago, according to media reports.

“We have just shy of 75,000 licensed beds,” California Gov. Gavin Newsom said earlier this week of the state’s hospitals. “We need an additional 50,000 beds in our system.”

The full Forbes article can be viewed at this link.  

CVS To Waive Co-Pays For Aetna Member Coronavirus Hospitalizations

CVS Health said it will waive co-payments and related out-of-pocket cost-sharing of commercially insured Aetna members’ inpatient admissions related to the Coronavirus strain COVID-19.

The move is among the more significant thus far among health insurance companies that are expanding coverage and eliminating plan member cost-sharing for everything from doctor office visits for Coronavirus tests to telehealth consultations for screening of the disease.

The full Forbes article can be viewed at this link.  

Fair Allocation of Scarce Medical Resources in the Time of COVID-19

Governments and policy makers must do all they can to prevent the scarcity of medical resources. However, if resources do become scarce, we believe the six recommendations we delineate should be used to develop guidelines that can be applied fairly and consistently across cases. Such guidelines can ensure that individual doctors are never tasked with deciding unaided which patients receive life-saving care and which do not. Instead, we believe guidelines should be provided at a higher level of authority, both to alleviate physician burden and to ensure equal treatment. The described recommendations could shape the development of these guidelines.

Previous proposals for allocation of resources in pandemics and other settings of absolute scarcity, including our own prior research and analysis, converge on four fundamental values: maximizing the benefits produced by scarce resources, treating people equally, promoting and rewarding instrumental value, and giving priority to the worst off. Consensus exists that an individual person’s wealth should not determine who lives or dies. Although medical treatment in the United States outside pandemic contexts is often restricted to those able to pay, no proposal endorses ability-to-pay allocation in a pandemic. 

Each of these four values can be operationalized in various ways. Maximization of benefits can be understood as saving the most individual lives or as saving the most life-years by giving priority to patients likely to survive longest after treatment. Treating people equally could be attempted by random selection, such as a lottery, or by a first-come, first-served allocation. Instrumental value could be promoted by giving priority to those who can save others, or rewarded by giving priority to those who have saved others in the past. And priority to the worst off could be understood as giving priority either to the sickest or to younger people who will have lived the shortest lives if they die untreated.

The proposals for allocation discussed above also recognize that all these ethical values and ways to operationalize them are compelling. No single value is sufficient alone to determine which patients should receive scarce resources. Hence, fair allocation requires a multivalue ethical framework that can be adapted, depending on the resource and context in question.

These ethical values — maximizing benefits, treating equally, promoting and rewarding instrumental value, and giving priority to the worst off — yield six specific recommendations for allocating medical resources in the COVID-19 pandemic: maximize benefits; prioritize health workers; do not allocate on a first-come, first-served basis; be responsive to evidence; recognize research participation; and apply the same principles to all COVID-19 and non–COVID-19 patients.

The full article with recommendations from The New England Journal of Medicine can be downloaded below.  

Washington, DC – March 23, 2020 – Today, eHealth Initiative (eHI) sent a letter to Congress, signed by 21 leading digital health and health IT organizations, outlining support for certain provisions of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, as well as additional steps to combat the COVID-19 pandemic.

“Digital health, telehealth, and remote monitoring technology can help providers effectively triage and treat COVID-19 patients,” says Jennifer Covich Bordenick, Chief Executive Officer of eHI. “There is an urgent need to remove regulations and help providers scale this technology quickly.”

The letter outlines support for telehealth provisions, including increased funding, as well as provisions related to the sharing of patient health information. It asks Congress to take additional steps to support telehealth, remote patient monitoring, expand broadband for rural areas, advance patient matching, fund artificial intelligence use and testing, and provide regulatory relief for providers and hospitals.