Editors’ note: This is part two of a two-part series. Read part one here.
My late Carnegie Mellon professor, Lester Lave, studied the green energy business. One would think that his philosophy skewed liberal (and one would be right), but among his most impactful lessons at the Tepper School of Business was the “Iron Law of Government.”
It was so simple and matter of fact that it could fit on a bumper sticker (and likely has at some point): “When government gets involved, everybody loses.” (Note: This law may not apply outside the U.S., but it appears to hold true at every level of American government).
Even in united governments, Lave meant that consensus is rare and fickle. There are few areas of politics, business, medicine, and technological innovation—to name just four of life’s thorny dimensions—that are what I would call an “ethical arbitrage,” i.e., a decision with no downside. A poignant example of one is ensuring that Fire and EMS personnel, arriving to the scene of a child with special health needs in crisis, knows what those needs are prior to arrival on-scene.
There is no downside to such awareness—only upside for the patient, the family, the responders, the hospital that may eventually care for the patient, and the broader society. How many decision points are so clear? As Lave saw it, government getting involve inheres a “best fit” solution that ultimately pleases no one in full. Yes, it’s compromise—but everybody loses, at least a bit.
Occasionally, however, government’s involvement generates a return on investment of time and debate that is dramatically positive because the status quo benefits so few that almost anything is better than the current. Among these is the difficulty that patients and care providers face in gaining access to healthcare data, including and especially the risk faced by everyone—patients, their families, responders, society—that something important will be missed or delayed.
Since the HITECH Act (which bolted onto HIPAA) became law as part of the American Recovery and Reinvestment Act of 2009 (the giant federal “Stimulus Act”), healthcare systems have been navigating the question of who can share what with whom and when and why and how much must it cost to do so.
These questions—plus the special privacy provisions of 42 CFR Part 2, which govern the sharing and redaction of mental health- and substance use- related patient data—have been at the heart of interoperability challenges, and the Mobile Medical profession’s continued dismay that they frequently don’t get outcomes reported back by hospitals.
Forget that a frequent problem with the lack of data return is the lack of data to return on the hospital side…nevertheless, the question of engineering and support costs has long loomed over every discussion about adapting interfaces and workflows to share among ambulance, fire or community paramedicine services; hospital systems, clinics, and nursing facilities; the ePCR system used by each field service agency; and the electronic health record and/or regional health information exchange systems (sometimes, more than one EHR and/or HIE are in place for a single healthcare system).
Such a “clear as mud” status quo often keeps responders feeling like they cannot meaningfully participate at the healthcare table. That changed in July 2023, and it has meaningful (pun intended!) implications for the Mobile Medical profession, including Fire, EMS, Non-Emergency/Interfacility Transport, Critical Care Transport, and Community Paramedicine services.
In July 2023, the U.S. Department of Health & Human Services’ Office of the Inspector General (OIG) “released a final rule establishing the statutory penalties created by the 21st Century Cures Act information blocking requirements. The final rule does not impose new information blocking provisions. OIG incorporated regulations published by ONC as the basis for enforcing information blocking penalties. If OIG finds that an individual or entity has committed information blocking, they may be subject to up to a $1 million penalty per violation.”
The Information Blocking Final Rule begins to bulldoze the economic impediments that prevent information sharing between Mobile Medical agencies, and between Mobile Medical agencies and hospitals and health information exchanges. At least four technology systems in our profession’s ecosystem today appear to meet the federal definition of a health information exchange (HIE) or network (HIN).
According to the Code of Federal Regulations:
Health information network or health information exchange means an individual or entity that determines, controls, or has the discretion to administer any requirement, policy, or agreement that permits, enables, or requires the use of any technology or services for access, exchange, or use of electronic health information:
(1) Among more than two unaffiliated individuals or entities (other than the individual or entity to which this definition might apply) that are enabled to exchange with each other; and
(2) That is for a treatment, payment, or healthcare operations purpose, as such terms are defined in 45 CFR 164.501 regardless of whether such individuals or entities are subject to the requirements of 45 CFR parts 160 and 164.
The Information Blocking Final Rule is meant to approximate a data version of the “surprise billing” prohibition: organizations must know the costs associated with interoperability upfront, so they have the prerogative to accept them (or not). This change has a financial implication because as recently as this month—after the Final Rule was published—a Midwestern EMS agency asked for its data to be shared with its statewide health information exchange.
The agency’s ePCR vendor said it would have to present a quote to do so. The Information Blocking Final Rule lets companies charge “fees that result in a reasonable profit margin, for accessing, exchanging, or using electronic health information” in a defined set of circumstances (see below)—but such charges cannot be based on competitive factors, like trying to set up roadblocks to other companies working in a region where one vendor has historically dominated.
Agencies also can’t be charged twice. If a Mobile Medical agency is charged for a subscription to a regional interoperability service, then the hospital cannot also be charged for it. If the hospital is charged, then the Mobile Medical agency cannot be charged. “Double dipping” has been an issue for agencies across America, for years, although such tactics are no longer allowed. Agencies are encouraged to review the guidance presented via Cornell Law School’s Legal Information Institute.
Here are selections from the Final Rule:
(1) The fees an actor charges must be—
(i) Based on objective and verifiable criteria that are uniformly applied for all similarly situated classes of persons or entities and requests;
(ii) Reasonably related to the actor’s costs of providing the type of access, exchange, or use of electronic health information to, or at the request of, the person or entity to whom the fee is charged;
(iv) Based on costs not otherwise recovered for the same instance of service to a provider and third party.
(2) The fees an actor charges must not be based on—
(i) Whether the requestor or other person is a competitor, potential competitor, or will be using the electronic health information in a way that facilitates competition with the actor;
(ii) Sales, profit, revenue, or other value that the requestor or other persons derive or may derive from the access, exchange, or use of the electronic health information;
(iii) Costs the actor incurred due to the health IT being designed or implemented in a non-standard way, unless the requestor agreed to the fee associated with the non-standard design or implementation to access, exchange, or use the electronic health information;
(v) Opportunity costs unrelated to the access, exchange, or use of electronic health information; or
(b) Excluded fees condition. This exception does not apply to—
(2) A fee based in any part on the electronic access of an individual’s EHI [electronic healthcare information] by the individual, their personal representative, or another person or entity designated by the individual;
(4) A fee to export or convert data from an EHR technology that was not agreed to in writing at the time the technology was acquired.
Organizations that subscribe to any software that meets the federal definition of a health information exchange or network should get to know—upfront—the costs associated with interoperability. They can no longer to be imposed after-the-fact; cannot be used as an impediment to collaborating with other companies; and must be “reasonable” i.e., related to explainable costs.
All of which should bode well for agencies that use ePCR systems and want to make Mobile Medical interoperability a near-term reality.
More from the Author
Brave New Interoperable World: Part 1: The Black Swan Event of Fire RMS Data
The Economics of Co-Response: Designing a Sustainable Approach
The Powerful Potential for Artificial Intelligence in Mobile Medicine & Fire
