By MATTHEW HOLT

I am dipping into two rumbling controversies that probably only data nerds and chronic care management nerds care about, but as ever they reveal quite a bit about who has power and how the truth can get obfuscated in American health care. 

This piece is about the data nerds but hopefully will help non-nerds understand why this matters. (You’ll have to wait for the one about diabetes & chronic care).

Think about data as a precious resource that drives economies, and then you’ll understand why there’s conflict.

A little history. Back in 1996 a law was passed that was supposed to make it easy to move your health insurance from employer to employer. It was called HIPAA (the first 3 letters stand for Health Insurance Portability–you didn’t know that, did you!). And no it didn’t help make insurance portable.

The “Accountability” (the 1st A, the second one stands for “Act”) part was basically a bunch of admin simplification standards for electronic forms insurers had been asking for. A bunch of privacy legislation got jammed in there too. One part of the “privacy” idea was that you, the patient, were supposed to be able to get a copy of your health data when you asked. As Regina Holliday pointed out in her art and story (73 cents), decades later you couldn’t.

Meanwhile, over the last 30 years America’s venerable community and parochial hospitals merged into large health systems, mostly to be able to stick it to insurers and employers on price. Blake Madden put out a chart of 91 health systems with more than $1bn in revenue this week and there are about 22 with over $10bn in revenue and a bunch more above $5bn. You don’t need me to remind you that many of those systems are guilty with extreme prejudice of monopolistic price gouging, screwing over their clinicians, suing poor people, managing huge hedge funds, and paying dozens of executives like they’re playing for the soon to be ex-Oakland A’s. A few got LA Dodgers’ style money. More than 15 years since Regina picked up her paintbrush to complain about her husband Fred’s treatment and the lack of access to his records, suffice it to say that many big health systems don’t engender much in the way of trust. 

Meanwhile almost all of those systems, which already get 55-65% of their revenue from the taxpayer, received additional huge public subsidies to install electronic medical records which both pissed off their physicians and made several EMR vendors rich. One vendor, Epic Systems, became so wealthy that it has an office complex modeled after a theme park, including an 11,000 seat underground theater that looks like something from a 70’s sci-fi movie. Epic has also been criticized for monopolistic practices and related behavior, in particular limiting what its ex-employees could do and what its users could publicly complain about. Fortune’s Seth Joseph has been hammering away at them, to little avail as its software now manages 45%+ of all encounters with that number still increasing. (Northwell, Intermountain & UPMC are three huge health systems that recently tossed previous vendors to get on Epic).

Meanwhile some regulations did get passed about what was required from those who got those huge public subsidies and they have actually had some effect. The money from the 2009 HITECH act was spent mostly in the 2011-14 period and by the mid teens most hospitals and doctors had EMRs. There was a lot of talk about data exchange between providers but not much action. However, there were three major national networks set up, one mostly working with Epic and its clients called Carequality. Epic meanwhile had pretty successfully set up a client to client exchange called Care Everywhere (remember that).

Then, mostly driven by Joe Biden when he was VP, in 2016 Congress passed the 21st Century Cures Act which among many other things basically said that providers had to make data available in a modern format (i.e. via API). ONC, the bit of HHS that manages this stuff, eventually came up with some regulations and by the early 2020’s data access became real across a series of national networks. However, the access was restricted to data needed for “treatment” even though the law promised several other reasons to get health data.

As you might guess, a bunch of things then happened. First a series of VC-backed tech companies got created that basically extract data from hospital APIs in part via those national networks. These are commonly called “on-ramp” companies. Second, a bunch of companies started trying to use that data for a number of purposes, most ostensibly to deliver services to patients and play with their data outside those 91 big hospital systems.

Which brings us to the last couple of weeks. It became publicly known among the health data nerd crowd that one of the onramp companies, Particle Health, had been cut off from the Carequality Network and thus couldn’t provide its clients with data.

The supposed reason was that they were getting data without a “treatment” reason.

Now if you really want to understand all this in detail, go read Brendan Keeler’s excellent piece “Epic v Particle”. Basically Particle cried foul and unusually both Michael Marchant, a UC Davis Health employee & the Chair of the big health systems on the ”Care Everywhere Committee” (remember that from earlier?) and then Epic itself responded. Particle’s founder Troy Bannister in a linkedin post and an official release from Particle said that they had not received notice or any evidence of what they’d done wrong. Michael said they had. I started quoting the Dire Straits line “two men say they’re Jesus, one of them must be wrong.” (FD. Troy was briefly an intern at Health 2.0 long, long ago).

Then Epic publicly released a letter to its clients explaining that, contrary to what Troy & Particle said, it had been discussing this with Particle for months and had had several meetings before and after it cut them off. So unless Particle’s legal counsel was parsing its words very very carefully, they knew Epic and its clients were unhappy, and it was unlikely Troy was Jesus. Michael might still be, of course. (Update: as of 4/15/23 Particle says only some feeds were cut off not all of them as Epic suggested)

In the letter Epic named 4 companies who were using Particle’s data in a way it didn’t like– Reveleer and MDPortals (who are one not two companies as they merged in 2023 before this issue started), Novellia and Integritort. 

So what do they do with the data. Reveleer says that “leveraging our AI-enabled platform with NLP and MDPortals’ sophisticated interoperability allows us to deliver providers a pre-encounter clinical summary of patients within their EHR workflow at the point of care.” Sounds like treatment to me. But Reveleer also does analysis for health plans. You can see why hospitals might not like them.

Novellia is a PHR company, presumably using “treatment” to enable consumers to access their data to manage their own care. This was EXACTLY what Joe Biden wanted the 21st  Century Cures Act to give patients the right to do and what Epic CEO Judy Faulkner told him he shouldn’t want (depending exactly who you believe about that conversation). But it’s probably not a particular “treatment” under HIPAA, because who believes patients can treat themselves or need to know about their own data anyway? (I’ll just lock you all in a room with Dave deBronkart, Susannah Fox and Regina Holliday if you want the real answer). This is apparently the line where ONC folded in its ruling to the vested interests that providers (and their EMR vendors) didn’t have to provide data to patient requests.

Finally, Integritort does sound like it’s looking for records so it (or its law firm customers) can sue someone for bad treatment (or as it turns out defend them for it). Is that “treatment” under the HIPAA definition?  Almost certainly not. On the other hand, do the providers cutting them off have a vested interest in making sure no outside expert can review what they’ve been up to? I think we all know the answer to that question. 

But anyway it looks like Particle switched off Integritort’s access to Carequality on March 22nd before Particle was entirely switched off by Carequality sometime around April 1.

What is not answered in the letter is why, if Carequality can identify who these records are going to, it needed to switch all Particle’s access off. Additionally, you would think that Particle’s path of least resistance would be to cut off the named clients Epic/Carequality was concerned about and try to sort through things while keeping its system running–which it seems it did with Integritort. Whatever happened, instead of this negotiation continuing behind the scenes, we all got to witness a major power play–with clearly Epic & its big customers winning for now.

I think most people who are interested in getting access to data for patients are all agreed on the need for new “paths” which were already defined in the regulations but not implemented, and also presumably for agreed standards (with associated liability) of “know your customer laws” for the onramps like Particle to make sure that the clients using them are doing the right things vis a vis confirming patient identity et al. 

Slight digression: I am confused about why identity proofing is such a big deal. In recent weeks I have had to prove my identity for the IRS, for a credit union, and for the TSA. Not to mention for lots of other websites. There are companies like IDme, Clear and many others that do exactly this. I don’t see anything so specific about health care that is different from credit cards, bank accounts, airport safety, etc. Why can those agencies/organizations access all that data online but for some reason it’s a bridge too far for health care?

However you can see where the fault lines are being drawn. There are a lot of organizations, many backed by rich VCs or huge quasi-tech corporations, that think they can do a much better job of caring for Americans than the current incumbents do. (Whether they can or not is another matter, but remember we are spending 18% of GDP when everyone else spends 10-12%). Those organizations, which include huge health plans, tech cos, retail clinics, startup virtual care clinics, and a whole lot more, need data. Not everything they or the intermediaries they do will fit the “treatment” definition the current holders of that data want to use. On the other hand, the current incumbents and their vendors are extremely uninterested in any changes to their business model.

Data may be the new oil but, like oil, data needs refining to power economies and power health care services. We spent much of the last century fighting about access to oil, and we’re going to spend a lot of this one fighting about data. Health care will be no exception.

Matthew Holt is the publisher of The Health Care Blog

By ROSEMARIE DAY and DAVID W. JOHNSON,

The Affordable Care Act (ACA) survived its third challenge at the Supreme Court on June 18, 2021, by a 7-2 vote, signaling that Obamacare is here to stay. With a divided Congress and a Biden administration challenged by multiple urgencies, there is little hope for national legislation to address healthcare’s access, cost, and quality deficiencies comprehensively. 

Despite this lack of dramatic progress or sweeping change at the federal level, reformers need not lose hope. Quietly, state-based marketplaces are making health insurance provision more accessible, affordable and effective. 

A Biden Administration’s executive order signed in January 2021, reopened the federal health insurance marketplace to individuals seeking to purchase or modify health insurance policies. The fifteen state-based marketplaces (SBMs) followed suit by enacting their own versions of this special enrollment period.

The Administration’s $1.9 trillion American Rescue Plan, enacted on March 11, 2021, includes a narrow but powerful provision that temporarily grants premium subsidies to higher-income Americans and reduces premium costs for lower-income Americans.  The “Build Back Better Act” currently moving through the House of Representatives would make these subsidies permanent. It would also provide funding for more experimentation with state-based health insurance affordability programs.

These new policies align with measures undertaken by many SBMs during the past eight years to improve the quality, affordability, and marketability of their health insurance offerings. In this decentralized, real-world way, SBMs have operated as experimental policy laboratories to assess programming modifications for stabilizing local markets, expanding consumer choice, increasing access to vital healthcare services, and lowering premiums. 

Successful SBM innovations have demonstrated that insurance marketplaces can adapt and thrive by responding to consumer preferences. By expanding to more states, adopting proven remedies, and more effectively overseeing plan sponsors, SBMs can provide even more Americans with access to the affordable health and wellness services they need.

THE EVOLUTION OF STATE-BASED MARKETPLACES

Enacted in 2010, the ACA introduced guidelines and provided start-up funding for SBMs. The legislation’s aim was to create affordable health insurance options that Americans lacking health insurance coverage could purchase on market-based exchanges.

Inspired by Massachusetts healthcare reform (aka “Romneycare”), the framework built on non-ACA purchasing cooperatives offering “small group” health insurance plans. The new marketplaces enabled individual consumers to purchase ACA-compliant health insurance coverage online. The ACA also provided income-based subsidies for qualified enrollees. 

The ACA’s designers believed that most states would develop their own marketplaces. They established HealthCare.gov, a federally operated alternative, to provide access to ACA plans in states that chose not to create SBMs. 

Political resistance impeded the widespread adoption of SBMs at the outset. Yet, SBMs have not only thrived in the years since they are now poised to expand. Kentucky, Maine, and New Mexico are launching their own state-run marketplaces this fall for operation in Plan Year 2022. Others, including Virginia, will likely follow. 

Source data:  Kaiser Family Foundation  https://www.kff.org/health-reform/state-indicator/state-health-insurance-marketplace-types/?activeTab=map&currentTimeframe=0&selectedDistributions=marketplace-type&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D

SBMs operate as marketplaces for insurers to compete in offering plans that meet ACA-regulated standards. SBMs also promote enrollment, pool risk to lower premiums, and facilitate comparison shopping.

A CRITICAL SAFETY NET

Including HealthCare.gov, 12 million consumers have enrolled in market-based plans for the calendar year 2021, an increase of 600,000 from 2020. Over 3.8 million of the 12 million enrolled through SBMs. The vast majority of enrollees (including 88% of the consumers enrolled through HealthCare.gov) receive some financial assistance in the form of subsidies.

Despite the increased enrollment, more than 30 million Americans remain uninsured and 43.4% of the population has inadequate health insurance coverage. The number of uninsured people in America declined significantly with the implementation of the ACA in 2014, then began to rise in 2017 as the Trump Administration reduced support for enrollment. 

The pandemic-related economic shutdown seemed likely to balloon the ranks of the uninsured. Instead, employer-based coverage largely held and many who found themselves suddenly uninsured secured coverage through Medicaid or marketplace health plans. 

The extension of the open enrollment period and the enhanced subsidies have facilitated enrollment in SBMs and HealthCare.gov this year. For an estimated one million people, marketplace health plans provided a critical safety net.

CONTINUED GROWTH & IMPROVEMENT

Despite the charged political debate since the ACA’s passage, SBMs have shown great promise and resilience. Many SBMs have adopted targeted solutions to make health plan premiums more attractive and affordable. Some have enabled consumers to shop and compare plans more easily. Others have included reinsurance, enhanced subsidies, and/or individual mandates that strengthen the risk pool and help to reduce prices.

Different approaches among states can lead to drastic differences in the affordability and attractiveness of health plan offerings. Minnesota’s decision to offer reinsurance to insurers with health plans on its SBM lowered its 2021 monthly benchmark rate to $292. Across the state line in Wisconsin, the monthly benchmark rate jumped to $782. The 2021 national average benchmark premium is $443 per month.

Analysts, administrators, and policymakers are studying these different approaches to better understand the factors influencing the elasticity of demand in state and federal marketplaces. The results can be striking. 

One study showed that the existence of individual mandates in state-based marketplaces increases the likelihood that individuals will purchase health insurance policies, regardless of financial penalties.  Other studies confirm that individual tolerance for higher premiums increases with a greater perceived need for health insurance, as occurs with factors such as poor health and older age. Such priorities increase demand for health insurance and reduce price elasticity. 

That said, a standardized menu of affordable options increases consumer sensitivity to price. States can adopt an evidence-based approach by using this type of knowledge to tweak program offerings and make them more attractive to marketplace consumers. 

SBMs monitor each other’s strategies closely, often adopting innovations appropriate to local needs. By using an evidence-based approach, they can make their offerings even stronger. Progress will also stimulate interest in other states for developing their own marketplaces. As noted above, SBMs’ collective success has already influenced several traditionally red and purple states, including Kentucky, Maine, New Mexico, and Virginia, that are now implementing their own SBMs.

With political headwinds now turning into tailwinds, SBMs are finding it easier to enact modest but practical structural improvements that can make their marketplaces even more robust and attractive. Growth will continue as more product offerings come to SBMs, consumers gain more choices, value-driven transactions increase, health outcomes improve and system-wide costs decrease.

CONCLUSION: LOCAL SOLUTIONS ADVANCING MEANINGFUL REFORM

The ACA gives states the flexibility to implement SBMs and encourage private sector participation. The federal government is responsible for establishing coverage standards, financing subsidies, and operating the HealthCare.gov platform. But it faces some challenges when it comes to innovating.

By contrast, states can be nimble. They can tailor program offerings to meet market demands and dynamics. Factors influencing program design could also include the state’s urban/rural mix, the size of its employer base, the payer mix, social determinants of health, demographics, and cultural attributes. This ability to accommodate market preferences and other factors validates the federalist approach that the ACA takes in granting SBM program design to the states.

This flexibility avoids the “one-size-fits-all” approach incorporated within the federally run marketplace. By tailoring their SBMs to local circumstances, the states have become vital engines of experimentation and innovation for advancing the overall effectiveness of the nation’s healthcare marketplaces.

With enhanced program design and expansion to more states, along with support from the Build Back Better Act, SBMs are well-positioned to serve as a catalyst for meaningful healthcare reform. Not all progress is revolutionary. As SBMs have demonstrated, evolutionary improvements in benefit design, enrollee engagement, risk management, and outreach enable millions of American consumers to gain affordable access to high-quality care.

For additional detail, please see a summary of these and many other state actions to support access to health insurance coverage from the Commonwealth Fund:  https://www.commonwealthfund.org/publications/maps-and-interactives/2021/sep/what-your-state-doing-affect-access-adequate-health?redirect_source=/publications/maps-and-interactives/2021/mar/what-your-state-doing-affect-access-adequate-health 

Rosemarie Day is the founder and CEO of Day Health Strategies (www.dayhealthstrategies.com), a consulting firm dedicated to transforming the US healthcare system.

David Johnson is the CEO of 4sight Health, a thought leadership and advisory company working at the intersection of strategy, economics, innovation, and capital formation.

Sources:

¹ Andrews, M. (2021, February 15). As Biden Reopens ACA ENROLLMENT, are you eligible to sign up or switch HEALTH PLANS? NPR. https://www.npr.org/sections/health-shots/2021/02/15/967366282/as-biden-reopens-aca-enrollment-are-you-eligible-to-sign-up-or-switch-health-pla. 

² Kliff, S. (2021, January 16). One sentence In Biden stimulus Plan reveals his health care approach. The New York Times. https://www.nytimes.com/2021/01/16/upshot/biden-obamacare-stimulus.html; American rescue PLAN Act funding breakdown. NACo. (2021, July 29). https://www.naco.org/resources/featured/american-rescue-plan-act-funding-breakdown  

³ HEALTH INSURANCE MARKETPLACES 2021 OPEN ENROLLMENT REPORT. CMS.gov. (n.d.). https://www.cms.gov/files/document/health-insurance-exchanges-2021-open-enrollment-report-final.pdf.    

⁴ Finegold, K., Conmy, A., Chu, R. C., Bosworth, A., & Sommers, B. D. (2021, February 11). TRENDS IN THE U.S. UNINSURED POPULATION, 2010-2020. HHS.gov. https://aspe.hhs.gov/sites/default/files/private/pdf/265041/trends-in-the-us-uninsured.pdf.   

⁵ Collins, S. R., Gunja, M. Z., & Aboulafia, G. N. (2020, August 19). U.S. health insurance coverage in 2020: A looming crisis in affordability. Health Coverage Affordability Crisis 2020 Biennial Survey | Commonwealth Fund. https://www.commonwealthfund.org/publications/issue-briefs/2020/aug/looming-crisis-health-coverage-2020-biennial. 

⁶ COVID enrollment period. ACA Signups. (n.d.). https://acasignups.net/covid-enrollment-period.   

⁷ Minemyer, P. (2021, May 24). Average benchmark premiums for ACA exchange Plans decline again IN 2021: Report. FierceHealthcare. https://www.fiercehealthcare.com/payer/average-benchmark-premiums-for-aca-exchange-plans-decline-again-2021-report#:~:text=Average%20benchmark%20premiums%20for%20plans,fell%20by%201.7%25%20for%202021. 

⁸ Saltzman, E. (2017). Demand for Health Insurance: Evidence from the California and Washington ACA Marketplaces. University of Pennsylvania Scholarly Commons. https://repository.upenn.edu/cgi/viewcontent.cgi?article=1140&context=hcmg_papers 

⁹ Abraham, J., Drake, C., Sacks, D. W., & Simon, K. I. (2017, July 24). Demand for health insurance marketplace plans was highly elastic in 2014-2015. NBER. https://www.nber.org/papers/w23597. 

¹⁰ It’s worth noting that states that establish their own marketplaces can recapture the user fee that they must pay to the federal government for participating in HealthCare.gov. This is a sizeable assessment that can save states millions of dollars. See: Schwab, R., & Volk, J. A. (2019, June 28). States looking to run their own health insurance marketplace see opportunities for funding, flexibility. States Looking to Run Own Insurance Marketplace https://www.commonwealthfund.org/blog/2019/states-looking-to-run-their-own-health-insurance-marketplace-see-opportunity.     

By MIKE MAGEE

The power to mandate vaccines was litigated and resolved over a century ago. Justice John Marshall Harlin, a favorite of current Chief Justice Roberts, penned the 7 to 2 majority opinion in 1905’s Jacobson v. Massachusetts. Its impact was epic.

In 1905, Massachusetts was one of 11 states that required compulsory vaccinations. The Rev. Henning Jacobson, a Lutheran minister, challenged the city of Cambridge, MA, which had passed a local law requiring citizens to undergo smallpox vaccination or pay a $5 fine. Jacobson and his son claimed they had previously had bad reactions to the vaccine and refused to pay the fine believing the government was denying them their due process XIV Amendment rights.

In deciding against them, Harlan wrote, “liberty for all could not exist under the operation of a principle which recognizes the right of each individual person to use his own [liberty]…” 

Of course, a state’s right to legislate compulsory public health measures does not require them to do so. In fact, as we have seen in Texas and Florida among others, they may decide to do just the opposite – declare life-saving mandates (for masks or vaccines) to be unlawful. At least 14 states have passed laws barring employer and school vaccine mandates and imposing penalties in Republican-controlled states already.  

So state powers are clearly a double-edged sword when it comes to health care. 

Questions anyone?

Does the Federal government have the power to come to the rescue? 

NO. Judgments thus far refer specifically to states’ rights. These include the 1922 decision, Zucht v. King, where the decision supported a local public school district’s right to require vaccination for admission to the school. In this decision, Judge Louis Brandeis wrote, “a state may, consistently with the federal Constitution, delegate to a municipality authority to determine under what conditions health regulations shall become operative.” 

Can the federal government forcibly require or compel you to get vaccinated in the U.S.(with exceptions for religion and disability)?  

NO.

Isn’t that what they are doing with a mandate? 

NO. A vaccine mandate means the government is “setting a condition on you returning to society or participating in a particular activity.” 

If a state doesn’t mandate masks, distancing, or vaccines and a business decides to, is that legal? 

With appropriate exceptions for religion and disability, when the intent is to protect employees and customers, legal scholars believe YES, although this remains to be adjudicated..

If a business asks me if I’m vaccinated on entry, is that a HIPAA violation? 

NO. HIPAA regulations restrict hospital and health care workers, not store clerks.

Doesn’t the First Amendment give me the right to reject vaccines?

NO. According to legal scholars: “Freedom to believe in a religion is absolute under the First Amendment. However, freedom to act in accordance with one’s religious beliefs ‘remains subject to regulation for the protection of society.’”

Didn’t the FDA “Emergency Use Authorization” require vaccine mandates? 

NO. This authorized the sale and distribution of the vaccine but did not require anyone’s use of it.

Is President Biden doing all he can, within the powers of the Executive Branch, to protect Americans from the pandemic? 

Legal expert, Georgetown Law professor Lawrence Gostin, says YES. “While states have near plenary power to protect the public’s health, the federal government’s powers are limited…(Biden) is acting fully lawfully pursuant to those powers.

1. the president “is using his executive power to order vaccinations for the federal workforce. (this includes members of the Military.) 

2. He is using his spending power through Medicaid and Medicare to ensure vaccine mandates in health care settings. 

3. And he is using the Occupational Health and Safety Act to mandate vaccinations in all businesses of 100 or more employees. All of these are comfortably within the president’s power.”

Biden could go farther and attempt, by providing financial rewards to states that mandate vaccines, or through the Commerce Claus to limit non-mandated states interstate travel, to extend compliance, but these would most certainly generate extended legal challenges. Federal Law under Title VII of the Civil Rights Act of 1964 and Title I of the Americans with Disability Act also require vaccine exemptions for religious and medical reasons to be in place. (Nationally, less than 1% have claimed these exemptions.)

As for the states, it’s a messy affair. While Texas Governor Abbott grandstands, the federal District Court in Texas in Bridges et al v. Houston Methodist Hospital refused relief for any of the 117 employees suspended and threatened with termination if they refused to get vaccinated. The decision read: plaintiffs “can freely choose to accept or refuse a COVID-19 vaccine; however, if [they] refuse, [they] will simply need to work somewhere else…Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”

In another recent case, the US Court of Appeals for the Seventh Circuit in Indiana, and the Supreme Court in an appeal, denied relief to eight Indiana University students barred from attendance because they refused to comply with mandated vaccination. Students had chosen not to apply to the university for a medical and religious exemption, which if granted would permit attendance if they wore masks.

States nationwide generally require entering students to have proof of up-to-date vaccines to prevent 11 childhood diseases.

Over a century ago, the fight over vaccines was no less heated than it is today. A New York Times editorial at the time of the Jacobson 1904 decision, tagged the dispute as  “a conflict between intelligence and ignorance, civilization and barbarism” 

On the “intelligence” side, Nearly 60 top medical organizations released a joint statement on July 22^nd in support of mandated vaccines for all health care and long-term care workers as a “logical fulfillment of the ethical commitment” to patients.

Mike Magee, MD is a Medical Historian and Health Economist and author of “Code Blue: Inside the Medical Industrial Complex.“