By KIM BELLARD

Perhaps you’ve heard about the controversial Alabama Supreme Court ruling about in-vitro fertilization (IVF), in which the court declared that frozen embryos were people. The court stated that it has long held that “unborn children are ‘children,’” with Chief Justice Tom Parker – more on him later – opining in a concurring opinion:

Human life cannot be wrongfully destroyed without incurring the wrath of a holy God, who views the destruction of His image as an affront to Himself. Even before birth, all human beings bear the image of God, and their lives cannot be destroyed without effacing his glory.

Seriously.

Many people have already weighed in on this decision and its implications, but I couldn’t resist taking some pleasure in seeing “pro-life” advocates tying themselves in knots trying to explain why, when they legislated that life begins at conception, they didn’t mean this kind of conception and that kind of life.

John Oliver was typically on point, noting that the Alabama ruling was “wrong for a whole bunch of reasons. Mainly, if you freeze an embryo it’s fine. If you freeze a person, you have some explaining to do.”

The case in question wasn’t specifically about IVF, nor did the ruling explicitly outlaw it. It was a case about a patient who removed stored embryos and accidentally dropped them, and the couples whose embryos were destroyed wanted to hold that patient liable under the Wrongful Death of a Minor Act. The court said they could. Note, though, that neither the patient nor the clinic was being charged with murder or manslaughter…yet.

Although the Alabama Attorney General has already indicated he won’t prosecute IVF patients or clinicians, the ruling has had a chilling effect on fertility clinics in the states, with The University of Alabama at Birmingham health system and others indicating they were putting a pause on IVF treatments.

Justice Parker has long been known as something of a theocrat; as The New York Times wrote:

Since he was first elected to the nine-member court in 2004, and in his legal career before it, he has shown no reticence about expressing how his Christian beliefs have profoundly shaped his understanding of the law and his approach to it as a lawyer and judge.

His concurring opinion claimed: the state constitution had adopted a “theologically-based view of the sanctity of life.” Alabama is not alone. Kelly Baden, the vice president for public policy at the Guttmacher Institute, told BBC: “We do see that many elected officials and judges alike are often coming at this debate from a highly religious lens.”

Speaker Johnson has said:

The separation of church and state is a misnomer. People misunderstand it. Of course, it comes from a phrase that was in a letter that Jefferson wrote. It’s not in the Constitution. And what he was explaining is they did not want the government to encroach upon the church — not that they didn’t want principles of faith to have influence on our public life. It’s exactly the opposite.

And here we are.

Many Republicans are backtracking on the ruling.

Alabama Republican Governor Kay Ivey said she was “working on a solution.” Alabama legislators are already working on bills to protect IVF, clarifying that in vitro fertilization doesn’t count, with life only beginning when implanted in a uterus. Oh, OK, then.

Presumed Republican presidential nominee Donald Trump says he “strongly” supports IVF, and Republican Speaker of the House Mike Johnson said: “I believe the life of every single child has inestimable dignity and value. That is why I support IVF treatment, which has been a blessing for many moms and dads who have struggled with fertility,” Alabama Senator Tommy Tuberville somewhat hilariously managed to somehow both support the ruling and the need for IVF.

Eric Johnston, president of the Alabama Pro-Life Coalition, admitted:

It’s a win philosophically for the pro-life movement because it carries on the pro-life recognition of unborn life. But you get into a very difficult situation, where you have this medical procedure that’s accepted by most people, and then how do you deal with it? That’s the dilemma… But I think the pro-life community in general supports IVF, and I’ve known and worked with many people who have had children via IVF. And at the same time, they think abortion is wrong. This issue is so different from abortion, but it has to do with life.

The trouble is, red states are scrambling all over themselves passing ever-more restrictive abortion laws, with the “life begins at conception” mantra, and, despite what Speaker Johnson and other House Republicans say now, 125 of them have cosponsored the Life at Conception Act that makes no exception for IVF.

Gosh, who could have guessed IVF would be impacted by all this?  Well, anyone who thought about it for a half second.

Although IVF only accounts for about 2% of births, it has been around for decades. An untold number of embryos are routinely stored (frozen) and, in some cases, destroyed. Now people like Republican Governor Greg Abbott would have us believe IVF is taking us all by surprise:

These are very complex issues where I’m not sure everybody has really thought about what all the potential problems are and as a result, no one really knows what the potential answers are. And I think you’re going to see states across the country come together grappling with these issues and coming up with solutions.

Once a fetus or an embryo is a person, what rights do they have, when do they qualify for tax credits/welfare/child support, and how do their rights compare to other people? As Jacob Holmes suggested in the Alabama Political Reporter: “Imagine you are in an in vitro fertilization clinic that is on fire, and you have time to save only 100 frozen embryos or a single 2-year-old child.” Do you save the most “lives,” or the only one actually breathing?

I know what I’d do.

I would be remiss if I didn’t note that Alabama has the third highest infant mortality rate in the U.S. (thank you, Arkansas and Mississippi!), and that it was one of 15 (red) states that is rejecting federal funds to help feed hungry children doing the summer (Alabama has some 500,000 such children).  

Evidently, unborn or frozen “people” matter more than live ones.

—————

These are, I admit, complex ethical issues, but trying to legislate them, especially from the standpoint of one particular religious point-of-view, is only going to lead to more outcomes like we’re seeing in Alabama. Democracy demands that we do better to listen than to tell.

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor

Participatory Medicine is a movement in which patients, caregivers and healthcare professionals actively collaborate and encourage one another as full partners in healthcare. 

The Society for Participatory Medicine with the support of our sponsor NRC Health Presents A Creative Learning Exchange(CLE): Community Health Access and Equity

Date: October 20, 2022 Time: 12:00 noon – 4:00pm (Lunch Is Included for In-Person)

Location: Brown Advisory, 100 High Street, 9th Floor, Boston, MA 02110

For more details and to REGISTER TODAY click here.

The Society for Participatory Medicine believes that the culture of healthcare is not benefiting everyone equally and needs to change. And healthcare won’t get better until healthcare culture gets better. We want to drive this change by enabling collaboration, education, information sharing, and communication among patients, caregivers, and health care professionals. Join the movement! 

This Creative Learning Exchange, in-person and online hybrid event, will be highly interactive and participatory, using a ‘Neighbors at Each Table’ approach to engaging you in facilitated discussion and brainstorming. 

These discussions will focus on applying the Participatory Medicine Manifesto behaviors in culturally and racially diverse communities to enable access and equity in care. Your ideas, insights and solutions that emerge will be curated by SPM to build a toolkit of participatory medicine guidelines. These will be shared with you and through SPM’s social networks, website and blog. 

For more details and to REGISTER TODAY click here.

Thank you to our series sponsor NRC Health. Thanks to Massachusetts General Hospital Equity & Community Health for sponsoring the meal. Thanks for Brown Advisory for proving the venue & AV.

Hospital consolidation has risen to the top of the health policy stack. David Dranove and Lawton Burns argued in their recent Big Med:  Megaproviders and the High Cost of Health Care in America (Univ of Chicago Press, 2021) that hospital consolidation has produced neither cost savings from “economies of scale” nor measurable quality improvements expected from better care co-ordination. As a consequence, the Biden administration has targeted the health care industry for enhanced and more vigilant anti-trust enforcement.

However, as we discussed in a 2021 posting in Health Affairs, these large, complex health enterprises played a vital role in the societal response to the once-in-a-century COVID crisis. Multi-hospital health systems were one of the only pieces of societal infrastructure that actually exceeded expectations in the COVID crisis. These systems demonstrated that they are capable of producing, rapidly and on demand, demonstrable social benefit.

Exemplary health system performance during COVID begs an important question: how do we maximize the social benefits of these complex enterprises once the stubborn foe of COVID has been vanquished? How do we think conceptually about how systems produce those benefits and how should they fully achieve their potential for the society as a whole?

Origins of Hospital Consolidation

In 1980, the US hospital industry (excluding federal, psych and rehab facilities) was a $77 billion business comprised of roughly 5,900 community hospitals. It was already significantly consolidated at that time; roughly a third of hospitals were owned or managed by health systems, perhaps a half of those by investor-owned chains. Forty years later, there were 700 fewer facilities generating about $1.2 trillion in revenues (roughly a fourfold growth in real dollar revenues since 1980), and more than 70% of hospitals were part of systems. 

It is important to acknowledge here that hundreds more hospitals, many in rural health shortage areas or in inner cities, would have closed had they not been rescued by larger systems. Given that a large fraction of the hospitals that remain independent are tiny critical access facilities that are marginal candidates for mergers with larger enterprises, the bulk of hospital consolidation is likely behind us. Future consolidation is likely not to be of individual hospitals, but of smaller systems that are not certain they can remain independent. 

Today’s multi-billion dollar health systems like Intermountain Healthcare, Geisinger, Penn Medicine and Sentara are far more than merely roll-ups of formerly independent hospitals. They also employ directly or indirectly more than 40% of the nation’s practicing physicians, according to the AMA Physician Practice Benchmark Survey. They have also deployed 179 provider-sponsored health plans enrolling more than 13 million people (Milliman Torch Insight, personal communication 23 Sept, 2021). They operate extensive ambulatory facilities ranging from emergency and urgent care to surgical facilities to rehabilitation and physical therapy, in addition to psychiatric and long-term care facilities and programs.

Health Systems Didn’t Just “Happen”; Federal Health Policy Actively Catalyzed their Formation

Though many in the health policy world attribute hospital consolidation and integration to empire-building and positioning relative to health insurers, federal health policy played a catalytic role in fostering hospital consolidation and integration of physician practices and health insurance. In the fifty years since the HMO Act of 1973, hospitals and other providers have been actively encouraged by federal health policy to assume economic responsibility for the total cost of care, something they cannot do as isolated single hospitals.

• Managed Competition. Under the Paul Ellwood/Alain Enthoven/Jackson Hole Group vision of managed competition, a fragmented care system comprised of individual hospitals and autonomous physicians would be replaced by a limited number of Kaiser-like capitated integrated delivery systems serving regions and competing on price (e.g. premium/PMPM).  This vision of a consolidated health system assuming population risk has been the holy grail of US health policy for five full decades, embraced by Republican and Democratic policy advocates alike. For hospitals to remain independent was to risk being isolated and commoditized by larger enterprises, either insurer- or provider-sponsored. This fear of isolation resulted in waves of hospital consolidation during the late 1970s and 1980s in anticipation of a health care marketplace populated by regional integrated delivery networks.   

• Clinton Health Reforms. Under the proposed Clinton reforms in the early 1990’s, hospitals would only have access to revenues through capitated health payment from the anticipated regional purchasing alliances and could contract to be paid directly if they were capable of bearing and managing population risk. Otherwise, hospitals would have become isolated subcontractors whose offerings would have been commoditized by those who accepted population-based payment. Even though the Clinton reforms faltered, a large wave of hospital mergers and integration activity in the mid-1990’s anticipated their passage. 

• HITech and the ACA. In the wake of President Obama’s 2009 Hitch Act, White House technocrats actively encouraged hospitals to absorb their physicians’ practices as a vehicle for facilitating the adoption of electronic health records. Similarly, the ACA’s payment reform initiatives, particularly the centerpiece Shared Savings (ACO) Program, relied upon on the ability of health enterprises to reach and manage the care of large populations as a bridge to a fully capitated future, spurring yet another wave of hospital consolidation.

Integration of Care and Financing has Failed to Achieve Ambitious Social Goals

The fact that health systems have struggled to integrate insurance financing into their care operations has left a legacy of at best partial integration. According to business historians, the core strategic idea at the root of these policy proposals was flawed; health insurance and care delivery are very different businesses, in some ways diametrically opposed to one another.  

Hospital enterprises owning a health insurance business are thus engaged in unrelated diversification, a strategy that has long since lost favor in the business world due to poor returns on the investment. Robert Burns and colleagues found that the greater the investment in this type of diversification, the larger a health system’s losses. As we have argued elsewhere, Kaiser’s success looks increasingly like a one-off example. More than 80% of Kaiser’s enrollment remains in its originating Pacific Coast markets where it originated more than 70 years ago. 

And despite more than a decade long federal push for “value-based” payment and tens of billions invested by health systems in consulting and infrastructure, by 2020, capitated payment accounted for a scant 1.7% of median hospital revenues and risk-based payment (e.g. two-sided ACO-style risk) only 1.1%. Neither revenue source has grown measurably since 2014 (Moody’s Investor Service, 9 Sept 21). Almost 50 years after the HMO Act of 1973, in only a few communities in the country (Pittsburgh, San Diego and Portland) do at least two integrated delivery systems compete for health plan enrollment. 

Realistically, the Ellwood/Enthoven vision of a care system reorganized into risk bearing IDNs is not going to happen in the US. Yet the hospital and physician consolidation catalyzed by that vision has left most metropolitan areas with a few dominant health systems with undeniable market power in their commercial transactions with health insurer. This market dominance and observed pricing power has led to an increasing policy hostility towards health system scale, with commercial prices being used as the singular measure of performance.

Meanwhile, other large corporate actors have appeared that seek to integrate care across regions without owning hospitals. The two largest enterprises in the US health system, each exceeding $250 billion in annual revenues, do not own a single hospital. They are UnitedHealth Group and CVS/Aetna, diversified health insurers with impressive arrays of primary and ambulatory health services as well as pharmacy benefits management and operations and in CVS/Aetna’s case, a nationwide chain of retail pharmacies. How one pays or regulates these vast non-hospital enterprises, just two of which accounted for more than 13% of US health spending in 2020, in a way that maximizes societal benefit is a conversation that has not even begun.

How to Think about Measuring Social Benefit from Large Health Systems

It is not clear to us that having a highly fragmented health system with thousands of actors each covering a piece of our health needs and competing aggressively on unit price is in the society’s best interests.  A comprehensive conceptual framework for assessing the social contribution of complex health systems—hospital-centric or not—is needed. Fortunately, Donald Berwick did exactly such a thing in 2008 by proposing what he called the Triple Aim. While Berwick meant it to represent achievable goals for health systems, we think it is also valuable as a societal benefit framework measured across a region.

Berwick later added a fourth Aim, improving the work experience of clinicians, in recognition of the challenges of professional burnout and stress, which have been dramatically heightened by the COVID crisis.

 In applying Berwick’s formulation, it is not whether a system exceeds a certain numeric threshold of market concentration, but how the merged entity affects its communities’ health and welfare after the attorneys and consultants go home that really matters.

More specifically, a health system’s societal contribution should be evaluated based upon:

1. Its ability to reduce per capita care costs in the populations they serve
2. Its ability to reduce errors and increase measured patient satisfaction by improving the care experience.   
3. Its ability to improve population health in their communities, especially by attacking and ameliorating social determinants of health.
4. Its ability to engage clinicians and improve their practice efficiency and satisfaction. 

Let’s discuss each of these and consider the ramifications for social benefit.

1. Per Capita Cost Reduction

Traditional anti-trust enforcement has focused on commercial price behavior as the measure of social impact of a merger. Yet modern systems offer thousands of products, each of which has a unique charge structure spread across multiple payers. Systems also differ markedly in the degree to which they serve government funded patients whose insurers (e.g. Medicare and Medicaid) pay less than the fully loaded cost of care, and thus rely on commercial insurance markups to offset these losses.    

However, the communities they serve generate health costs summed across all the people who live in a given region. Berwick believed that reducing per capita medical expense for the community as a whole was the highest and best use of health systems, whether or not they were paid for all those patients on a capitated basis. Since it is not realistic to expect that we will convert all provider payments to capitation, health systems will have to manage the tension between per incident payment for services and overall population level reductions in health expense. The burden of proof will lie in evaluating the specific mechanisms systems use to reduce per capita expense.

These mechanisms could include the use of targeted comprehensive primary care aimed at older and chronically ill individuals, including the use of “extensivists”—primary care physicians and advanced practice nurses that reach out into the home and workplace to manage health risks proactively, the development of palliative care models for patients with advanced illness, employing digital/telehealth services that target not only chronic illness but also various forms of addiction, particularly to food, alcohol and opiates, telehealth tools that improve adherence to risk-reducing medications like statin drugs, vaccines and the use of predictive analytics, disease registries, and “hot spotting” of vulnerably co-morbid patients, among many other promising innovations.

North Carolina’s Novant Health has used community health workers who assess high utilizer patients for social determinants in their home, shelter, or location of choice. They connect patients to a variety of trusted community partners, addressing food, housing, workforce development and transportation barriers

The result: a 33% reduction in ED utilization, a 40% increase in medication adherence, and a 21% reduction in PHQ-9 score (measuring anxiety and depression).  According to Novant Health CEO Carl Armato, the most consistent piece of feedback from CHW patients is gratitude that someone took time to listen to and address their needs–they consistently report a remarkable patient experience.

Simply focusing on commercial prices as a metric of performance of health systems misses any recognition of the market context these systems operate in such as neighborhood poverty, racial and economic inequity, payer mix and disease burden and thus fails to address the financial viability and sustainability of these enterprises. How many large health systems, particularly Academic Health Centers, would survive in the face of an arbitrary Medicare-related price ceiling for commercial payment?   

We advocate a more nuanced assessment of economic contribution that balances an examination of per capita cost with the overall financial performance of health systems[1]. Since community wide per capita spending is difficult to capture, per capita Medicare spending would be a more easily accessible proxy measure.

2. Improving Safety and the Patient Experience

Health system consolidation should lead to systematic improvements in the patient experience. COVID clearly showed that larger health care organizations with significant IT systems and technical staffs were better able to scale up telehealth operations to compensate for the loss of in-person elective and emergency care and to sustain telehealth use when elective care resumed. The ability to stand up command centers and manage health resources (ICU beds, emergency rooms, clinical staffing and related support services) across a metropolitan area or region cannot be achieved by a large number of competing, freestanding facilities. 

The ability to create condition-specific care plans that envelop and extend complex care episodes (e.g. joint replacement, cardiac nerve ablation, etc) is enhanced by having multi-disciplinary clinical teams supported by data analytics and IT systems. Similarly, the ability to identify defects in clinical and administrative processes that expose patients to risk and to wasted time and cost is enhanced by having a larger base of participating clinicians. 

Pre-COVID, many health systems were building “digital front doors” to their care systems, using smartphone apps, call centers and digital health access to smooth entry into and passage through their care systems. Larger systems created by mergers have not only enhanced clout with regional clinicians but also with health insurers that should be used to bring down patient bills.  

These improvements should be measurable through improved HCAHPS ratings and rising net promoter scores. Similarly, reduced clinical errors and improved clinical productivity are measurable and should be discoverable by patients and community members.

3. Improving Population Health through Addressing Social Determinants

In his “Poverty and the Myths of Health Reform,” the late Dr. Richard (Buz) Cooper persuaded us that the most important intervening variable in the widely observed variation in hospital and specialty use from community to community was not the supply of specialists and hospital beds, but rather the prevalence of poverty—the main social determinant of health.  Homelessness, food insecurity, broken families, unemployment, health illiteracy all stem from poverty, and generate both avoidable illness and costs.

These conditions cannot be ameliorated by health systems, or “competition” between isolated pieces of the care system, because they ultimately originate in our culture and society. The United States has grossly underinvested in the social care needed to ameliorate these conditions. These underlying social conditions that drive a lot of “unnecessary” health care use cannot be ameliorated through the core businesses of health systems, but rather through their collaboration with other entities with community wide reach, as well as neighboring public health systems—the very kind of collaboration we saw across the country during COVID.  

There are many examples of this type of collaboration:

1. California’s public health collaborative to attack and reduce maternal mortality, in which hospitals played a decisive role. This multi-year collaboration succeeded in reducing maternal mortality by more than half to rates comparable to western Europe, with concomitant reductions in PICU stays, infection-driven lengthy hospital stays, etc.

• Blue Zone Collaboratives. These collaboratives focus on specific neighborhoods or districts, and identify gaps in access to food, housing, public safety and social/human services that, when ameliorated, contribute to lengthening life expectancy in the geography chose. Health systems are key actors in most of the 56 projects currently underway.

• Mental Health Collaborations. In many communities, both public and private mental hospitals have closed, and services for those in mental health crisis have been absorbed, with predictable results, by local law enforcement. In metropolitan Seattle, health systems that normally compete for patients—MultiCare and CHI Franciscan Healthcare—collaborated to build a $41 million 120 bed inpatient psychiatric facility
   
• Addressing Homelessness. Numerous health systems (including Kaiser Permanente, Promedica, Truman Health, etc. ) have moved to create living spaces for homeless people in their communities, which has vastly simplified bringing community-based services and job opportunities to them.

Many health systems are engaging community partners in addressing income inequality, unemployment, educational opportunity, food insecurity, homelessness and racism. Some health systems such as Promedica in Ohio and Novant Health in the Carolinas are making upstream investments in housing and social services and to act as “anchor institutions” for community development. Other systems such as Ohio Health and Inova Health focus on their core clinical mission but embrace partnerships with community organizations. 

Novant Health has created a program for “Expanding Opportunity through Education”—investing in education programs with students of color and economically-disadvantaged communities where there are significant disparities in college readiness rates. Individuals who do not graduate high school are more likely to report suffering from at least one chronic health condition—asthma, diabetes, heart disease.  

Under new CEO Dr. Stephen Jones, Virginia’s Inova Health System has a partnership model for community engagement. Inova established twenty care clinics in zip codes of need based on data and community input with over 100,000 visits in 2021. Realizing the effects of what Jones terms “social drivers of health” the Inova Cares Clinics house Community Health Workers embedded in the neighborhoods to build trusting relationships, as well as pantries to address food insecurities. In addition, in partnership with local Title I schools and non-profits, Inova is working to create career journeys for students. Inova also supports 30 community organizations through health equity grants totaling $1M to leverage relationships for real impact in the community.

The normative expectation should be that because larger health systems serve larger populations, and therefore are exposed to larger community risk factors and needs, they can and should be expected to devote resources and talent to addressing them. The existing approach to evaluation of community benefits (as in the IRS definitions and the requirements under the Affordable Care Act) are sorely in need of re-examination to account more fully the range of initiatives being pursued.   

4. Improving Care Giver Experience

One area where large health systems have struggled is in improving the working lives and professional satisfaction of its caregiving workforce. COVID clearly demonstrated how much stress and pressure in health systems devolves onto front line care givers. While large health systems were ultimately able to procure the PPE needed to make their jobs safer, they were less effective in ameliorating the stress at the root of care during this crisis. Being highly dependent on an aging workforce, health systems face huge staffing gaps in the wake of COVID as burned-out baby-boom vintage doctors and nurses retire or transition to other, less stressful work roles.

Health system leaders are acutely aware that their clinical workforce are “spent” after more than two years of delivering front line care in a pandemic, increasingly to unvaccinated  and often hostile or violent patients. It has become a strategic imperative that health systems respond effectively in acknowledging and managing the mental health problems of their clinical workforce. Failing to acknowledge this problem has resulted in avoidable shortages in clinical staffing, and excessive reliance on mandatory overtime and temporary clinical workers or travelling nurses.

Clinician engagement is an important precondition for improving clinical quality and reducing medical errors. Large health systems have fewer excuses for not having worker sensitive (as opposed to litigation sensitive) human resource policies. Workforce satisfaction is easily measured through physician and staff engagement surveys.

Conclusion

We do not propose this performance framework as a regulatory guide for state or federal authorities. Rather it is presented as a voluntary alternative for managements and Boards seeking to demonstrate the community benefits created by their institutions.   

At their best, large health systems can deliver sophisticated, complex care to their communities. But they can also play a key role with community partners in addressing the social determinants of health, thus reducing per capita health cost. Large multi-billion health systems are here to stay. The conversation about how to enhance the health systems’ benefits to their communities, which have been so vital during COVID, has barely begun.   

Jeff Goldsmith is President, Health Futures Inc & Ian Morrison is the former President of Institute for the Future. One of them is America’s best known health futures, but we’re not sure which!

Acknowledgements

This essay has benefitted greatly from review, comments and examples provided by colleagues. In particular, we would like to thank health system CEOs and health policy experts Nancy Agee, Carl Armato, Carmela Coyle, Stephen Jones MD, Chip Kahn, Stephen Markovich MD, Tom Priselac and Michael Gentry.

[1] Nancy Kane, Robert Berenson and colleagues have pointed out that the financial performance of health systems differs materially based on their resource position, payer mix and other variables, and proposed a financial performance evaluation framework  based on audited financial reports to account for these differences .  The same is true of the geographical areas served by systems; those which serve communities like the Bronx or South Central Los Angeles face greater challenges than those serving suburban communities. Adding socio-economic domains based on geography to the Kane/Berenson framework would facilitate “apples to apples” comparisons of potential social benefit created by systems. 

Policies|Techies|VCs: What’s Next For Health Care? is the conference bringing together the CEOs of the next generation of virtual & real-life care delivery, and all the permutations thereof. You can register here or learn how to sponsor.

This is a big week. We are one week out and we’ve started pre-recording a few sessions and they’ve been fascinating. Keynotes include government officials from the 3 most important agencies for digital health –Pauline Lapin (CMS), Micky Tripathi (ONC) & Bakul Patel (FDA). But wait there’s more! Keynotes from techies Glen Tullman (Transcarent), Sean Lane (Olive), Jonathan Bush (Zus Health), Jeff Dachis (One Drop) & Andrew Dudum (Hims & Hers). And we’re not forgetting the VCs sprinkled through the program, with a keynote from Andreesen Horowitz’s Julie Yoo.

Please look at the agenda for 20 power-packed panels and over 100 speakers – and then sign up!

Shout out to our sponsors – This week we welcome new Gold sponsor data privacy company Skyflow and new Silver sponsor Amwell. Thanks to both of them for supporting the conference. They join Avaneer Health (our Platinum sponsor) & exclusive Agency sponsor 120/80. Sliver sponsors are Transcarent & Lark . More sponsors are Aetion. Merck GHIF, Crossover Health, Zus Health, Newtopia, Aetion & Big Health! Many of them will have sessions you can catch on the web site.

It’s going to be a great conference–no need to leave your seat as it’s happening virtually September 7-10. Register here!! — Matthew Holt

Rosemarie Day has been a long time health care consultant and operator, most prominently as the COO of the Massachusetts Health Connector–the first real state exchange that was created as part of Romneycare (which with a few twists later became Obamacare!) Following the 2017 Women’s March, Rosemarie decided to write her own book, Marching Towards Coverage. It’s really four books in one. A personal patient & caregiver journal; a history of the slow march towards universal health care; a policy document; and a primer on how to become an activist. All in less than 200 pages! For the November THCB Book Club Jessica DaMassa and Matthew Holt talked with Rosemarie about what we can all do to really get to better health care for everyone.

By VINCE KURAITIS and DEVEN McGRAW

Two years ago we wouldn’t have believed it — the U.S. Congress is considering broad privacy and data protection legislation in 2019. There is some bipartisan support and a strong possibility that legislation will be passed. Two recent articles in The Washington Post and AP News will help you get up to speed.

Federal privacy legislation would have a huge impact on all healthcare stakeholders, including patients.  Here’s an overview of the ground we’ll cover in this post:

• Why Now?
• Six Key Issues for Healthcare
• What’s Next?

We are aware of at least 5 proposed Congressional bills and 16 Privacy Frameworks/Principles. These are listed in the Appendix below; please feel free to update these lists in your comments.  In this post we’ll focus on providing background and describing issues. In a future post we will compare and contrast specific legislative proposals.

Why Now?

A number of factors have contributed to bringing the privacy issue to the near boiling point:

Techlash and Surveillance Capitalism. Facebook scandals, Cambridge Analytica, Russian election interference, tech addiction, data breaches — all have contributed to the techlash against Silicon Valley giants and have raised growing calls for regulation.

A central theme is the growing public understanding of how personal data has been harvested. In a recent Blis survey, 63% of consumers responded that they were “more aware” of how personal data is used by companies versus a year ago.

The crescendo of criticisms is only getting louder. Harvard Law professor Shoshana Zuboff’s recently published book The Age of Surveillance Capitalism takes techlash to new levels. She writes: “Surveillance capitalists soon discovered that they could use these data not only to know our behavior but also to shape it.”

European Regulations. Europe now has the world’s strongest privacy and data protection regulation. The EU General Data Protection Regulation (GDPR) came into force in May 2018.

State Regulation.  The California Consumer Privacy Act (CCPA), which goes into effect in January 2020 and is modeled after GDPR, has broad reach and has large companies that collect health (or health-related) information scrambling for federal relief.  The State of Washington and others appear to be following suit.

Tech companies are realizing that the status quo is not an option. The United States does not have a comprehensive federal data protection law. Instead, the U.S. legislative framework for privacy and information security consists of multiple laws that regulate the private sector primarily on a sector-by-sector basis, with multiple regulatory authorities dedicated to oversight.

Six Key Issues for Healthcare

What provisions are likely to be included in a new federal privacy law? The Information Technology and Innovation Foundation (ITIF) recently released a report that lists 30 possible components of privacy laws (see the callout box).

Information Technology & Innovation Foundation, https://itif.org/publications/2019/01/14/grand-bargain-data-privacy-legislation-america

The ITIF report provides explanations of each of these components. We’ll reference many of them in our list of six issues that we think will be particularly important for patients and other healthcare stakeholders:

• Is There Federal Preemption of State Legislation?
• Is All or Part of HIPAA Rescinded?
• How Are Interests ACROSS Stakeholder Groups Addressed?
• How Are Interests WITHIN Stakeholders Groups Addressed?
• How are Next Generation Technologies Addressed?
• How Will New Privacy Legislation be Enforced?

Let’s look at these individually.

1) Is There Federal Preemption of State Legislation?

This promises to be a contentious issue. A simple way to look at this — is federal law a floor or a ceiling for consumer rights?

Tech companies are fearful of unharmonized legislation passed in U.S. states and countries across the world. They would prefer to see one federal law that prohibits states from passing their own laws. Global companies would prefer to see one federal law that is in harmony with GDPR.

Fearful of weak federal legislation, consumer advocates at least initially will prefer to see federal legislation that continues to allow states to pass stronger laws. 16 privacy groups submitted a letter to Congress supporting strong state privacy laws and opposing federal preemption.

This opposition to federal preemption could soften when considering federal legislation that would provide strong consumer protections.

2) Is All or Part of HIPAA Rescinded?

HIPAA (the Health Insurance Portability and Accountability Act privacy, security and breach notification regulations) does not protect all health related data — it only covers health information in the hands of HIPAA-covered entities (primarily care providers, health plans, and healthcare clearinghouses) and their business associates (contractors who collect health information to perform services on a covered entity’s behalf). It does NOT protect health information in the hands of entities not specifically covered by HIPAA.  For example, HIPAA does not cover health information in consumer-facing apps.  HIPAA also does not apply to data that has been de-identified (rendered very low risk of re-identification).

How might federal privacy legislation affect HIPAA? That’s something of a wildcard for now. It’s possible that privacy legislation could expand HIPAA-like protections to non-HIPAA data, or it’s possible that federal legislation could perpetuate loopholes in not providing specific protections for health-related data.

Some are calling for a GDPR-like law that covers all personal data and eliminating all sector specific privacy laws.  In the interests of achieving a uniform, national privacy scheme, the ITIF Report specifically recommends rescinding HIPAA:

…federal privacy legislation should create a common set of federal protections for all types of data. This will mean removing duplicative or conflicting rules. To accomplish this, federal privacy legislation should sunset other sector-specific privacy laws, such as GLBA, HIPAA, and the Family Educational Rights and Privacy Act (FERPA), and bring the industries covered by those rules under a single federal data privacy law.

3) How Are Interests ACROSS Stakeholder Groups Addressed?

In the broadest sense, privacy legislation will be about meeting interests of consumers/patients vs. those of technology companies. Many tech companies increasingly are recognizing the need to reestablish and maintain consumer trust — and that this requires clearly delineated, transparent, and auditable practices.  But companies and consumers/patients are likely to disagree on exactly how to build and maintain that trust.

Components of privacy legislation that will be of most interest to consumers/patients relate to personal control over data:

• Data portability
• Rights to correct/rectify errors
• Rights to delete certain types of data
• Consents to data sharing and use
• Requirements that data is used only for specified purposes
• Limitations on secondary uses of data
• Time limits to data retention
• Requirements to gather/use/share as little data as possible
• Data security
• De-identification of data
• A private right of action for violations

Components of privacy legislation that will be of most interest to tech companies and many healthcare incumbents include:

• Harmonization of requirements across states and across countries (see the discussion on preemption above)
• Minimizing compliance costs
• Freedom to innovate
• Few limitations on data gathering/use/sharing
• Limiting penalties and private rights of action

4) How Are Interests WITHIN Stakeholders Groups Addressed?

Within major stakeholders in the HIPAA ecosystem there are dividing points of view. We’ll share a few examples.

Even those who advocate for a stronger federal law differ in their preferences:

Privacy maximalists will prefer the most stringent protection of consumer data. They will prefer to give individual patients as much control as possible in how their data is shared and used. “We’d like to see laws that require data to be gathered only for specific purposes, that these specific purposes be spelled out to patients, that patients must specifically consent to gathering and sharing of data, that data not be used beyond purposes specified, and that certain types of data be deleted after a specified time period.”

Privacy balancers will point out tradeoffs among components of privacy and will weigh costs and benefits. “We recognize that health data has significant potential to advance medicine and science; thus researchers and conductors of clinical trials need reasonable access to large sets of patient data.” (See the discussion in the next section)

Healthcare providers also are unlikely to have uniform views of privacy legislation. Some likely will welcome strengthened privacy protections. “We’re truly working to make our health system more ‘patient centric’. Specifying patient rights to data will help us to protect our patients and to carry out their wishes about how their data is shared and used.”

Other providers who might view data in medical records as “theirs” might prefer the status quo. “The ambiguities about ownership of medical information work to our advantage. We treat medical data as if it’s ‘ours’ and we see that it’s to our competitive advantage to do so.”

Health plans may be more likely to have consistent positions, supporting provisions that impose privacy rules on entities currently outside the HIPAA coverage bubble but preferring to continue to be governed by HIPAA versus being covered by new, less familiar rules. “HIPAA works just fine to protect information collected by health plans, but there should be a level playing field for all companies collecting health information.”

In the tech world, some companies have embraced surprisingly strong views favoring consumer protections:

Apple CEO Tim Cook: “We all deserve control over our digital lives. That’s why we must rein in the data brokers….Consumers shouldn’t have to tolerate another year of companies irresponsibly amassing huge user profiles, data breaches that seem out of control and the vanishing ability to control our own digital lives.”

Microsoft CEO Satya Nadella: I am hopeful that in the United States we will have something that’s along the same lines [as European GDPR regulations]. In fact, I hope that the world over we all converge on a common standard.”

Salesforce CEO Marc Benioff:

Benioff at #WEF19 ‘Facebook and Twitter need to change their CEO’s and their boards. Why dont they get on a stage and say: Im sorry, we are now going to put trust first?’ pic.twitter.com/cGBJQNN6A5

— Marietje Schaake (@MarietjeSchaake) January 24, 2019

These are just a few examples. However, it is unclear whether these strong commitments translate into support for a strong federal privacy law.

5) How are Next Generation Technologies Addressed?

Next generation technologies such as artificial intelligence, machine learning and analytics offer alluring promises of advancements in medicine and healthcare. Law professors Price and Cohen describe some of the potential:

Big data enables more powerful evaluations of health care quality and efficiency, which then can be used to promote care improvement. Currently, much care remains relatively untracked and underanalyzed; amid persistent evidence of ineffective treatment, substantial waste, and medical error, understanding what works and what doesn’t is crucial to systemic improvement.

Regulations often lag the capabilities of new technologies. As we mentioned in the introductory section, there are also significant concerns relating to techlash and surveillance capitalism. But these next generation technologies raise issues of discrimination and fairness which are related to but go beyond privacy concerns – for example, use of big data to make health care resource allocation decisions that exacerbate racial and ethnic disparities in care.

Some of the issues we see relating to potential privacy legislation include:

• Will data that are de-identified or anonymized (and how those terms are defined) remain more widely available for big data uses?
• Will the legislation address discrimination, or will we be left with merely the protections of GINA, the Americans with Disabilities Act, and the Affordable Care Act, all of which have loopholes?
• Does the legislation deal with the potential for bias in next generation technologies, such as by requiring fairness and/or transparency in the algorithms used to make decisions about individuals and/or populations?

6) How Will New Privacy Legislation be Enforced?

Here are some key questions to consider:

What agency or agencies will have authority to enforce health related aspects of new privacy legislation? Likely candidates include the Federal Trade Commission (FTC), the Office of Civil Rights (OCR) within Health and Human Services (HHS), or perhaps a newly created agency.

What amount and types of resources will be available to enforce new legislation?

Will the enforcing agency have ongoing rulemaking authority to address gaps in legislation and/or new technologies or industry practices?

Will patients be given a private right of action, i.e., the right to take companies to court?

Will state attorneys general and agencies be permitted to investigate and enforce violations of federal rules?

What’s Next?

Privacy legislation debates likely will become highly visible in 2019. A recent Harris/Finn poll found that “privacy of data” was the #1 issue that American companies should address, with 65% of respondents indicating it was “very important”.

The list of 30 components of privacy legislation speaks to the complexity of issued involved, and it also highlights many opportunities for compromise.

The ITIF Report described Congress’ key task as being “to balance competing goals such as consumer privacy, free speech, productivity, U.S. economic competitiveness, and innovation.”

This won’t be an easy task and we expect that it will take a while to play out. It might take longer than one year to develop Federal privacy legislation. It’s also possible that privacy legislation could become an important issue in the 2020 election.

We encourage you to pay attention, and to keep this important issue on your radar!

APPENDICES

Proposed and Pending Bills

Senator Rubio

Senator Wyden

Senators Blumenthal/Moran

Senator Schatz

Senators Klobuchar/Kennedy

Frameworks/Principles

Access Now

BSA The Software Alliance

Business Roundtable

Center for Democracy & Technology

Center for Digital Democracy

Computer & Communications Industry Association

Electronic Frontier Foundation

Electronic Privacy Information Center

Future of Privacy Forum

Google

Information Accountability Foundation

Information Technology Industry Council

Intel

Internet Association

The App Association

U.S. Chamber of Commerce

Vince Kuraitis, JD/MBA (@VinceKuraitis) is an independent healthcare strategy consultant with over 30 years’ experience across 150+ healthcare organizations. He blogs at e-CareManagement.com.

Deven McGraw , JD, MPH, LLM (@healthprivacy) is the General Counsel and Chief Regulatory Officer at Ciitizen (and former official at OCR and ONC). She blogs at ciitizen.com.

By MATTHEW HOLT

Those of you paying attention for the past few days might have noticed on the one hand a sense of optimism and unity as Barrack H. Obama, somewhat somberly, began his presidency.

Meanwhile, over the past few weeks the fur has been flying among the electrons on THCB while some very knowledgeable and opinionated health care wonks and geeks have been battling it out about what exactly we should be doing in terms of federal health care IT spending.

Given that even among you smart THCB readers this may be all a little perplexing, I’m going to try to try to make what I hope are some elucidating comments to put this argument in context. I’m doing this partly because I’m perplexed too, but also because I think that there is some hope for a middle road.

First the basics: As sometime THCB contributor & uber-CIO John Halamka makes clear in this excellent post about The Greatest Healthcare IT Generation, some $20 billion of the soon to be passed “spend it as fast as you can” stimulus package is going to be targeted towards health care IT. Now, that’s by no means the biggest part of the $800 billion or so package, and it’s not even the biggest part of the health care spending in the bill. Nearly $87 billion or so is going to support Medicaid, although that will mostly will be replacing cuts being forced on states.

Let’s be clear, the stimulus package’s main role is to stop the patient from bleeding out and will probably need to be joined by a bank restructuring the likes of which we’ve never seen. Health care is a sideshow, but $20 billion is still $20 billion, and given that the current health IT market is only between $20 and $30 billion annually, it’s a huge potential increase for the industry.

This spending is separate from any larger health care reform proposed by Obama, even though it appears that such a reform package is fairly likely to appear in Congress as soon as Daschle, Baucus and Kennedy get their ducks in a row. And of course, most of the issues that divide THCB’s various commentators on health IT are rooted in problems that only a major reform can solve. And realistically even those most optimistic about the prospects for reform don’t believe that the Obama/Daschle/Baucus plan will get at the core problems of the U.S. health care system any time soon.

The underlying problems: American health care has two linked and intertwined problems. First, (and it is first) due to America’s unique political history, most of the pain of dealing with increasing health costs is deposited on a poor (or soon to be poor) and relatively powerless minority of the population—the sick who are uninsured and underinsured. No one is really responsible for their financial well being, nor is any entity forced to make their cost of care equal to that of the rest of society. So the health care system has reacted rationally over the years by increasing what it charges the majority, and not worrying too much about that minority even as it grows. Every other rational country instead distributes that cost evenly by putting (more or less) everyone in the same financial pool, and puts someone (usually the government) in charge of the total cost of the system to society. The US is different, as it’s the only place where for the players in the system doing more means getting more absolutely. Everywhere else, the rest of society stops the health care system arbitrarily grabbing more resources.

The process whereby the health care system grabs more and more in the US comes mainly via an incredibly strong supplier community that has political control over the large share of spending that is government funded, and economic control over the main providers of private spending—employers. Of course it may not feel that way to the suppliers in the system but the numbers (share of GDP going to health care more than doubling over 30 years) don’t lie.

This leads to the second problem: The mechanism of that provider control is a payment system that encourages piece work, acute care, fixing rather than prevention, specialization over primary care, and—not least—big hospitals over community based clinics. Now as Atul Gawande points out in the New Yorker this week, it’s not as if every other country does exactly the opposite, but the scale by which we’ve tipped over here is unprecedented. And multitudes of articles on THCB over the years prove it out, and show that it’s very hard to change that status quo.

This starts to get us back to IT. The first significant use of IT in health care in the US was in large hospitals primarily aimed at accounting (and billing) for piece work. Eventually most large and many smaller hospitals began to extend their IT capabilities to automate other aspects of their activity, but even among the most sophisticated, the role of IT supported rather than transformed the way they delivered care. The goal of the hospital is after all for the hospital to thrive and prosper, not for the community to improve the care it gets at a lower cost. This has continued as IT investment has picked up, especially since 2003, and of course it’s been reflected in the stock price and profitability of the winners in health IT, notably Cerner and Epic.

Some other countries were introducing more clinically-based IT into their health care systems over the 1990s, and they tended to place it where their systems were focused—which tended to mean in primary care. The three Ns (Norway, Netherlands, New Zealand) along with the Danes & the Brits were close to 100% EMR use in office based primary care by the early 2000s. The UK was able to use this to actually track what its primary care docs were doing, and started paying them bonuses for doing the “right thing” in terms of prevention and evidence based medicine. But note that the IT was shoe-horned into a system which was by and large doing that already. It did not change the core way care was delivered. In fact in the UK the links between primary care (GPs) and specialty care (hospitals) are still by and large absent—despite a huge budgeted (and not fully spent) investment in Healthcare IT that exceeds what’s in the current US stimulus package for a country 1/5^th the population! The astute observer will also notice that several countries that don’t have EMRs in universal use among physicians, notably France and Germany, also have pretty well regarded health care systems.

So it’s a pretty fair assumption that IT use in health care will reflect the system it’s put into, rather than transform it to something completely different.

So why all the aggro? Since the Obama win and the recession made the stimulus a certainty and health care IT’s inclusion in it a reality, THCB has been the venue for a series of articles in the form of Open Letters to the Obama Administration by David Kibbe & Brian Klepper, a defense of the proposed spending by John Halamka, an analysis of the perversion of administrative simplification under HIPAA by interested parties (clearinghouses) from Rick Peters, all culminating in a declaration that Health IT is in fact ready, just add $20 billion, by Mark Leavitt yesterday. This argument has by no means been confined to THCB, and in fact this latest discussion was started mostly in a series in Health Affairs, in which Carol Diamond and Clay Shirky accused the current health IT establishment of “magical thinking”, while somewhat surprisingly Microsoft—which sells a lot more in copies of Windows and Office to hospitals than health care tools to consumers or small practices—in the person of its health care leader Peter Neupert suggested that we should take a pause before hitting the “buy” key, and spend money on outcomes not on technology for its own sake. And enfant terrible Jonathan Bush is warning anyone who’ll listen that we’ll be locking in place outmoded technology.

Essentially the argument comes down to two things (Warning—gross generalizations ahead!). I liken this to the common truism that dogs attach themselves to people while cats attach themselves to places

Outcomes vs. technology: The Kibbe/Klepper/Peters/Neupert/Bush faction (the dogs)assumes that we need to change the incentives in the system, and then IT will naturally follow—and the current embryonic decision support systems will flourish quickly. But that current clinical systems aren’t good enough to invest in mostly because current results from EMR installations are very disappointing.

Although they discuss incentives (and most of the $20 billion will probably be aligned with some P4P measures), the cats’ (Leavitt/Halamka/Kolodner) view is closer to the thought that if you get the appropriate clinical technology (essentially in-patient and outpatient EMRs) into the hands of clinicians, then they’ll figure out what to do with it, and eventually the government can pay them according to how well they do it. (Halamka is a bit more open about this also being an IT public works scheme).

Patients vs. facilities: There’s also a more philosophical bias which harkens back to the difference between American and European health care systems, but not in the way you might think. The dog faction is in general primarily in favor of light-weight tools (and standards) that allow for innovation and service of the consumer patient by primary care teams (that’s the European part). The recent emergence of Web-based tools and patient communities that allow patients to apply self-service techniques and easy communication with teams of providers (yes, yes, that’s Health 2.0) are for them the keys to enabling better care. These tools are relatively cheap (and flexible) and mirror the SaaS trends in the rest of technology. (Think Gmail vs Outlook).

The cats’ view is closer to the opinion that the real work in American health care happens in big hospital systems, and that the key is to get everyone connected to their core clinical systems. Hence the concern with standardizing on products and private networks (RHIOs) rather than allowing a mass of anarchic applications out on the Internet which are more likely to “mash-up” together.

What about the biases? There have been plenty of accusations of bias and self-interest on these pages, and it’s worth quickly looking at it. For example, Jonathan Bush believes he’s riding a wave towards a SaaS future, whereas most of his competitors are still MUMPS-based client sever technologies—he fears the $20bn will be used to subsidize SUVs in a world where AthenaHealth is selling the Prius. Mark Leavitt, while on loan to the Chairman of CCHIT is the former CEO of MedicaLogic (now the core of GE’s Centricity EMR product) and a former HIMSS official. Most people in health care think of HIMSS as a vendor promotion association. Halamka of course is part of a very large AMC and the chair of the HITSP standards organization which tends to favor larger systems, whereas Kibbe is well know for his work promoting the lighter weight CCR standard and his involvement in the American Academy of Family Physicians—long the orphans of our specialty dominated medical culture. I also suspect that Kibbe’s recent criticisms of the EMR haven’t exactly helped his chance of receiving consulting dollars from the major HIT vendors, but he is also involved in consulting with smaller companies that stand to benefit from the emergence of new models of care. And of course Brian Klepper and I are involved in Health 2.0 (together in a consulting venture and me as co-founder of a conference).

However, I perhaps naively choose to believe that everyone involved is motivated more by their cultural takes on what’s important for health care, than their desire to put a hand-out for the $20 billion. I think that these same positions would have been taken by the same people 6 months ago when the bailout was yet a twinkle in Obama’s eye.

So in change, can we find unity? So despite the fierce words and the grave differences of opinion, can cats and dogs live together in harmony? I think that in the spirit of Obama’s first days in power we can find some unity. At the same time we need to be realistic about what comes next.

First, we need to get rid of the notion that IT is going to transform our health care system. To transform healthcare we need to get real health reform right. Obama is not doing IT any favors by imposing that pressure on its use—the dogs are correct here.

Second, we are not immediately going to move away from an acute care, large system-focused health care environment. Any change towards overall more consumer-focused health management will continue to be slower than some of us might like. So getting those acute care facilities that are not at BIDMC or InterMountain levels of technology readiness in better shape can’t hurt.

Third, despite all the harsh words, as the bill now stands, most of the $20 billion will reward actions with some form of P4P. If the folks at HHS & CMS who will be responsible for crafting the incentive structures hear a more unified voice from the assorted commentators, geeks, cats & dogs arguing over here, we’ll likely get more incentives rewarding better process and less direction on particular technologies—which will be a good thing.

Fourth, there’s an underlying concern among the dogs that in the cat view (which is more clearly the “establishment view”) the patient is lost. Yet I still see Leavitt and the others from the establishment keen to bridge the gap to patients with connectivity tools and to give them control over their data in PHRs. And I don’t believe anyone is suggesting that we halt the rapid development in the ability of patients to manage themselves, and communicate with each other and clinicians, which is at the heart of Health 2.0.

So I have hope that, while the health IT part of the bailout will not be the ultimate cure for our health care system, it will help in many ways all over the system. I also hope that while there won’t be complete consensus both cats and dogs will agree that it should fit some core basic principles so that in years to come we’ll judge that this money was wisely spent.

Of course I’ll be reserving judgment at least till the bill makes it out of committee, and probably until we see exactly how CMS wants to spend the money!

Matthew Holt is to Founder of THCB. Follow him at @boltyboy. This piece was originally published in 2009. Read it here.

We need to design a system of health care that optimally meets the country’s needs while also being affordable and socially acceptable. Clinicians should be at the center of this debate if care delivery is to be designed in a way that puts quality of care before financial gain.

This challenge is too important to be left to politicians and policymakers. There is an urgent need for clinicians to step up, lead the debate and design a new future for health care. Placing professional responsibility for health outcomes in the hands of clinicians, rather than bureaucrats or insurance companies with vested interests, must be an ambition for all of us. We need to find the formula that meets the needs of the patients and communities we serve. A sincere collective effort by committed clinicians to design an effective system will lead to a health care system that has a democratic mandate and the appropriate focus on optimizing the outcomes patients and society need.

As clinicians enter the debate, they should keep three things in mind.

Promote the leadership role of clinicians

We need to help politicians and policymakers recognize the role of clinical leaders in shaping a transformed but effective health care system. Clinicians must redefine the debate so that it focuses first and foremost on patients and health outcomes. Cost effective care can and should be a byproduct of optimal care. Accomplishing this will provide a strong common purpose for efforts to address the challenges of designing outcome-based funding structures and improving access to care.

Explain appropriate levels of care

Clinicians must inform both policymakers and the wider public about appropriate levels of care and the appropriate venues of care. A disproportionate focus on the treatment of acute illness and injury, which consumes by far the most resources, will not serve our country well. Primary care accounts for most of the health care that is delivered in the United States. There are nearly 1 billion visits made to physicians’ offices every year in the United States, but there are fewer than 40 million hospital stays. We need to pursue every opportunity to direct care to the lowest cost venue of care that can effectively address a patient’s needs.

Adopt a data-driven approach to care

Any system must be driven by data, focused on outcomes, and designed to deliver the appropriate level and type of care. The current hospital-centric, overly referral-based system often leads to unnecessary referrals and an over reliance on the most expensive diagnostic tests and treatments. It also ignores other major determinants of health. Health problems related to lifestyle, such as obesity, smoking, substance abuse and diabetes will not be solved by more hospitals but rather through access to primary care physicians, innovations in public health, and lessons from the emerging discipline of behavioral modification.

The best outcomes can be achieved only when the system itself is healthy and built on real partnerships between patients and clinicians. Building a health care system centered on clinical professionalism and responsibility is the only way to achieve such partnerships and to ensure that all patients are well served.

Thanks to some pioneering individuals and organizations such as the Mayo Clinic, Virginia Mason, M.D. Anderson, Partners Healthcare, Texas Children’s Hospital, Kaiser and many others, we can now see enough of the future of health care to have a sense of what it will be. And it is exciting. Empowering. Better for patients and communities. The new ideas, vision, tools and methods capable of supporting meaningful change are falling into place.

A frequent companion of challenges is adversity. As hard as it is, one can view adversity as a privilege and an opportunity. During times of great change and adversity, we cannot control circumstances, but we can change how we view them. We need to lean into the adversity. Many involved in the healthcare profession need to see a glimpse of the future, understand their role in it and be sustained by a sense of hope. It is our responsibility — and privilege — to offer this to them.

In a 1913 speech, Sir William Osler said, “To have lived through a revolution, to have seen a new birth of science, a new dispensation of health, reorganized medical schools, remodeled hospitals, a new outlook for humanity, is an opportunity not given to every generation.”  To paraphrase Sir William’s message, we have an opportunity to witness a new birth of science, a new dispensation of health, a remodeled health system and a new outlook for humanity. Indeed, this is not an opportunity given to every generation. But it has been given to us. It is our revolution.

John Haughom, MD, former senior vice president of clinical quality, safety and IT for PeaceHealth, is a senior advisor to Health Catalyst and the author of “Healthcare: A Better Way. The New Era of Opportunity.”

There is a consensus that measuring performance can be instrumental in improving value in U.S. health care. In particular clinical areas, such as cardiac and intensive care, measurement has been associated with important improvements in providers’ use of evidence-based strategies and patients’ health outcomes over the past two decades. Perhaps most important, measures have altered the culture of health care delivery for the better, with a growing acceptance that clinical practice can and should be objectively assessed.

Nevertheless, as we argue in the full-length version of this paper, substantial shortcomings in the quality of U.S. health care persist. Furthermore, the growth of performance measurement has been accompanied by increasing concerns about the scientific rigor, transparency, and limitations of available measure sets, and how measures should be used to provide proper incentives to improve performance.

The challenge is to recognize current limitations in how measures are used in order to build a much stronger infrastructure to support the goals of increased accountability, more informed patient choice, and quality improvement. In the following paper, we offer seven policy recommendations for achieving the potential of performance measurement.

1. Decisively move from measuring processes to outcomes.

There is growing interest in relying more on outcome measures and less on process measures, since outcome measures better reflect what patients and providers are interested in. Yet establishing valid outcome measures poses substantial challenges—including the need to riskadjust results to account for patients’ baseline health status and risk factors, assure data validity, recognize surveillance bias, and use sufficiently large sample sizes to permit correct inferences about performance.

Read more.

2. Use quality measures strategically, adopting other quality improvement approaches where measures fall short.

While working to develop a broad set of outcome measures that can be the basis for attaining the goals of public accountability and information for consumer choice, Medicare should ensure that the use of performance measures supports quality improvement efforts to address important deficiencies in how care is provided, not only to Medicare beneficiaries but to all Americans. CMS’ current focus on reducing preventable rehospitalizations within 30 days of discharge represents a timely, strategic use of performance measurement to address an evident problem where there are demonstrated approaches to achieve successful improvement [6]. Read more.

3. Measure quality at the level of the organization, rather than the clinician.

Historically, the physician has been viewed as the leader of medicine, with responsibility for the care and outcomes of patients; in iconic photographs and paintings, the physician is seen as a lone, heroic figure. However, this focus on the individual is flawed for most measures of quality and presents substantial technical challenges. In recommending a focus on measuring outcomes rather than care processes, we consider surveys or other approaches to obtaining the perspectives of patients on the care they receive to be an essential component of such outcomes. Read more.

4. Measure patient experience with care and patient-reported outcomes as ends in themselves.

Performance measurement has too often been plagued by inordinate focus on technical aspects of clinical care—ordering a particular test or prescribing from a class of medication—such that the patient’s perspective of the care received may be totally ignored. Quality measure data should not only be technically correct, but should be organized such that their dissemination is a resource to aid in quality improvement activities. Read more.

5. Use measurement to promote the concept of the rapid-learning health care system.

Initiatives to promote performance measurement need to be accompanied by support to improve care. As such, quality measurement should be viewed as just one component of a learning health care system that also includes advancing the science of quality improvement, building providers’ capacity to improve care, transparently reporting performance, and creating formal accountability systems. Read more.

6. Invest in the basic science of measurement development and applications, including an emphasis on anticipating and preventing unintended adverse consequences.

The unfortunate reality is that there is no body of expertise with responsibility for addressing the science of performance measurement. The National Quality Forum (NQF) comes closest, and while it addresses some scientific issues when deciding whether to endorse a proposed measure, NQF is not mandated to explore broader issues to advance the science of measure development, nor does it have the financial support or structure to do so. Read more.

7. Task a single entity with defining standards for measuring and reporting quality and cost data, similar to the role the Securities and Exchange Commission (SEC) serves for the reporting of corporate financial data, to improve the validity, comparability, and transparency of publicly reported health care quality data.

There is a plethora of health care quality data being pushed out to the public, yet no rules to assure the accuracy of what is being presented publicly. The health care industry lacks standards for how valid a quality measure should be before it is used in public reporting or pay-for-performance initiatives, although some standards have been proposed. Read more.

Conclusion

The interest in promoting a health care system that rewards performance needs to be balanced with the practical challenges faced when measuring performance. Improvement requires substantial investments in the underlying science of measurement, greater care in communicating measurement results, greater attention to the role of measures in quality improvement efforts, and using performance data in more strategic ways. The adoption of flawed measurement approaches that do not accurately discriminate between providers can undermine professional and public support for provider accountability, reward indiscriminately, and divert attention from more appropriate and productive quality improvement efforts.

Robert A. Berenson, MD is an institute fellow at the Urban Institute.

Peter J. Pronovost, MD, PhD is the director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins, as well as Johns Hopkins Medicine’s senior vice president for patient safety and quality.

Harlan M. Krumholz, MD, is the director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation, director of the Robert Wood Johnson Foundation Clinical Scholars program at Yale University, and the Harold H. Hines, Jr. professor of cardiology, investigative medicine, and public health.

The authors thank Lawrence Casalino, MD, PhD, chief of the Division of Outcomes and Effectiveness Research and an associate professor at Weill Cornell Medical College, and Andrea Ducas, MPH and Anne Weiss, MPP of the Robert Wood Johnson Foundation for their helpful comments on this paper. This research was funded by the Robert Wood Johnson Foundation, where the report was originally published.

A seasoned colleague recently told me that some PowerPoint presentations have no power and make no point.

But sometimes, a picture really is worth a thousand words. Or maybe — in the case of any meaningful discussion of health reform, thanks to its density and complexity — it might be worth 10,000 words. Hence our handy little exhibit.

This picture captures the 10,000 words it would require to explain with technical precision where President Obama’s Affordable Care Act fits relative to all health reform plans. It places “ObamaCare” along an ideologically scaled continuum of all serious reform options developed, debated and discarded or ignored since the 1980s.

They are all here: from the single-payer, centrally controlled models popular with those who detest corporations and the influence of money in medicine — two actual, not imagined “government takeovers of health care” — to two free market, laissez-faire models favored by those who detest regulation and the heavy hand of government in medicine.

On the far left, the federal (or provincial) government is the main insurer, owns most hospitals, and employs most doctors. This pure form of single payer seems to be supported or reviled in equal measure — especially by the nation’s physicians. As a model for nationwide reform, it is like religion — people either believe it will be health care’s Messiah, or the anti-Christ, and no one will convince them otherwise. This model is the foundation for many of the systems in Europe, and the systems in Canada, Australia, New Zealand, and Singapore. Unbeknownst to many in their care, there are actually two working systems based on this model in the U.S. today: Kaiser and the Veterans Health Administration.

The second model, Medicare-for-All, differs from the pure form of single payer by retaining the current independence of most hospitals and doctors. This model jettisons private insurance companies, while an all-encompassing Medicare program pays for covered care delivered by today’s crazy quilt of providers: large and small groups, for-profit, religious-affiliated, independent, academic, the works. This is what Medicare beneficiaries have today — except for the 27 percent who opt for Medicare Advantage plans offered by private insurers. It is supported by those who believe it would bring the relative efficiencies, fairness and low administrative costs of Medicare to all, and reviled by those who think Medicare works like hell. Because there are oceans of data to support both views, this too is ultimately a matter of secular faith: government, good; government, evil.

Next is “managed competition,” the basis for the plan proposed by President and Hillary Clinton. This model is built on the current system of multiple private insurers and providers, but highly organizes and regulates both, mandating employers and individuals to participate and requiring everyone, with or without current coverage, to give up what they have and commit to one of several competing vertical insurer/provider entities. This model is based on managed care theories developed in the ’70s and ’80s, and when proposed by the Clintons in the early ’90s, was popular with much of the Washington technocracy and vilified by conservatives.

Most Republicans and health industry critics attacked “Hillarycare” as cumbersome, over-engineered, and hyper-bureaucratic. It was destroyed in the court of public opinion by an insurer-funded TV ad campaign — “Harry & Louise” — that people remember better than any details of the plan itself. Modified versions of this model exist in Germany and Israel, and in a handful of U.S. markets (e.g., San Francisco and Portland, Oregon, sort of) with vertically integrated providers who compete with Kaiser.

To the right of “Hillarycare” is President Obama’s Patient Protection and Affordable Care Act, known as “PPACA, “the ACA,” or “Obamacare.” It retains most of the features of the current employer, insurance and provider systems, but expands all of its current dimensions by mandating that most of the uninsured participate in it, unless their incomes are low enough to qualify them for an expanded version of Medicaid.

Obamacare requires insurers to compete for customers through health insurance exchanges, deeply misunderstood and thus easily politicized creatures, as I discussed here last week. Obamacare outlaws insurers’ discrimination — and price-discrimination — against people with prior health problems. And it standardizes insurance coverage by market to focus insurer competition on price and service rather than plan design. Because Obamacare requires insurers to cover all comers — and does away with caps on those with catastrophically expensive medical situations — it is funded by mandated participation by almost everyone, either directly or through employers. It is based on principles of market competition developed by conservatives and proposed by Republicans as an alternative to Hillarycare.

To the right of Obamacare are two versions of free market models — containers for the “replacement” options crafted by or pointed to those who want to “repeal and replace” Obamacare. Both shift all purchasing decisions about coverage and plan design to individuals and insurers, believing this will reshape markets and drive efficiency in pricing and overall medical resource use. Most versions do not require anyone to purchase insurance, nor any insurer to cover anyone.

The two models differ mainly with regard to how health insurance and non-covered medical expenses are treated by the tax code. Proponents of the model on the far right believe that market distortions created by the tax deductibility of health insurance and expenses are enormous, and the extra political mile it would take to eliminate these well worth the effort in terms of marketplace correction and health system self-reform.

The first of the two models on the right actually expands the current system of tax deductibility of health insurance and direct medical expenses to individuals and the self-employed. Its architects believe this would level the playing field for insurance purchasing, ease out the distorting role of the employer from the system, and convert much of what is covered today by health insurance to health savings accounts and cash payment. The model would allow small businesses and individuals to pool together to buy whatever coverage they wanted across state-lines — the “Association Health Plans” often put forward by Republicans — a modified version of which is included in Obamacare as the “Multi-State Plans.” We have a version of this model in the US right now in miniature: dentistry.

The model on the far right also seeks to reduce the role of the employer in health care, but is structured on the belief that a better, faster way to get there is by removing the tax deductibility health care spending. Its proponents believe this would extract employers from the system in short order, convert health insurance into something resembling auto and homeowners insurance, and maximize the power of market forces to control health care spending in general. Under this model, everyone is free to purchase whatever mix of insurance and services they want and can find, from whatever organization will sell it to them, at whatever price the market yields. Modified versions of this model exist in China and India on top of threadbare single-payer systems incapable of serving the needs of their large and growing populations and emerging middle classes.

The proponents of both models on the right believe their inherent pricing efficiency would drive the marketplace to very high deductible insurance plans while converting routine medical care to a cash-and-carry system. Both models would subsidize the uninsured and others priced out of these markets with either a “premium support” or “voucher” program — two ideas that sound similar but play out very differently as health care costs increase.

The core economic reform mechanisms of the two models on the right show up every few years by newcomers to health care from the business sector, usually after a jarring personal encounter with the health care system. The latest entry is David Goldhill and his Catastrophic Care: How American Health Care Killed My Father — and How We Can Fix It. The subsidy mechanism — loaded with dangerous ammo for semantic and political branding wars over “premium support” vs. “voucher” — is the economic fulcrum in Congressman Paul Ryan’s proposal for reforming Medicare.

The above illustration of health reform plans along a political continuum reveals one of the more bitter political ironies of our time: President Obama’s health care reform law is based, for the most part, on right-of-center ideas.

This may have escaped the notice of most journalists and pundits and, for obvious reasons, the president’s legion of political opponents. But it is an odd and awkward fact for those in the trenches of health policy who care more about reforming the health care system — if only in hard-fought, belated baby steps — than they do about the purity of models, the promotion of a broader ideology, or the mud-slinging and name-calling that has come to define our national politics.

That Obamacare is a right-of-center plan, especially when viewed relative to all viable alternatives, explains why it has so little political support from either side. Liberals hate Obamacare because it is not single-payer, and feeds tens of millions of newly insured people to what they revile as a money-gobbling, profit-obsessed health insurance dragon. Conservatives hate Obamacare because it is the heavy, stupid hand of Big Government choking whatever air is left out of the current, dysfunctional health insurance market. That, or because they cannot see beyond their political rage at President Obama to recognize their own ideas at the core of his health reform plan.

Ideologically, this makes Obamacare a political orphan. And Washington, D.C., even back in the days of decorum and actual policy discussions, has never been kind to political orphans. How else to explain why the president (e.g., in his inaugural address, State of the Union speech) makes almost no mention of what could prove to be his signature domestic achievement — even as tens of thousands of Americans working for health insurers, hospitals, physician practices and other health care organizations grind away at its implementation.

Perhaps this is because Obamacare, which will affect to some unknown degree nearly one-sixth of the U.S. economy, has been reduced to a broken political piñata. Another seasoned colleague recently told me that the reason I do not understand the disconnect here is because the health reform “debate” has nothing to do with the substance of Obamacare as policy and everything to do with its politics.

Those interested in understanding where the plan fits into decades of earnest struggle with this difficult and important subject — rather than scoring political points against the president — would be well advised to consult this one PowerPoint slide.

J.D. Kleinke is a pioneering health care information entrepreneur, medical economist, author, policy expert, and business strategist.