We begin by commending HHS, CMS, and ONC for skillfully addressing the pro-competitive and innovative essentials in crafting this Rule and the related materials. However, regulatory capture threatens to derail effective implementation of the rule unless HHS takes further action on the standards.
Regulatory capture in Wikipedia begins:
“Regulatory capture is a form of government failure which occurs when a regulatory agency, created to act in the public interest, instead advances the commercial or political concerns of special interest groups that dominate the industry or sector it is charged with regulating. When regulatory capture occurs, the interests of firms, organizations, or political groups are prioritized over the interests of the public, leading to a net loss for society. Government agencies suffering regulatory capture are called “captured agencies.” (end of Wikipedia quotation.)
The extent to which HHS has allowed itself to be influenced by special interests is not the subject of this comment. This comment is just about how HHS and the Federal Health Architecture can act to more effectively implement the sense of Congress in the 21st Century Cures Act.
TEFCA will succeed where previous national health information exchange efforts have failed only if it puts patients’ and families’, and/or their fiduciary agents, in control of health technology. This is the only path to restore trust in physicians, and to ensure accurate and complete data for treatment and research.
As physicians and patient advocates, we seek a longitudinal health record, patient-centered in the sense of being independent of any particular institution. An independent health record is also essential to enhancing competition and innovation for health services. TEFCA Draft 2 is the latest in a decade of starts down the path to an independent longitudinal health record, but it still fails to deal with the problems of consent, patient matching, and regulatory capture essential for a national-scale network. Our comments on regulatory capture will be filed separately.
We strongly support the importance in Draft 2 of Open APIs, Push, and a relationship locator service. We also strongly support expanding the scope to a wider range of data sources, beyond just HIPAA covered entities in order to better serve the real-world needs of patients and families.
However, Draft 2 still includes design practices such as the lack of patient transparency, lack of informed consent, and a core design based on involuntary surveillance. This institution-centered design barely works at a community level and leaves out many key real-world participants. It is wishful thinking to believe that it will work with expanded participant scope and on a national scale.
Electronic health records (EHRs) are a polarizing issue in health reform. In their current form, they are frustrating to many physicians and have failed to support cost improvements. The current round of federal intervention is proposed rulemaking pursuant to the 21st Century Cures Act calls for penalties for “information blocking” and for technology that physicians and patients could use “without special effort.”
The proposed rules are over one thousand pages of technical jargon that aims to govern how one machine communicates with another when the content of the communication is personal and very valuable information about an individual. Healthcare is a challenging and unique industry when it comes to interoperability. Hospitals spend lavishly on EHRs and pursue information blocking as a means to manipulate the physicians and patients who might otherwise bypass the hospital on the way to health reform. The result is a broken market where physicians and patients directly control trillions of dollars in spending but have virtually zero market power over the technology that hospitals and payers operate as information brokers.
What follows below are comments by Patient Privacy Rights on the proposed rule. The common thread of our comments is the need to treat patients and physicians, not the data brokers, as the real stakeholders.
Comments to the ONC Rule
Overview: 21st Century health care innovation, policy, and practice is increasingly dependent on personal information. This is obvious with respect to machine learning and risk adjustment, but personal information is now central to the competitive strategy for most of the health care economy, clinical as well as research. ONC’s drafting of this rule reflects the importance of competition to innovation and cost containment.
Far more attention has been devoted to the ways in which
industry consolidation has driven up health costs than to proposals on how to
remedy the situation. But the introduction of Medicare for All and Medicare for
More bills—however dim their short-term prospects are—has changed the terms of
the debate. It is time to think about how we can eliminate the market power of health
systems without causing harmful dislocations in health care and the economy.
Before we get to that, here are the main facts about
consolidation: As a handful of health insurers have become dominant in many
markets, health systems have done likewise in order to maintain or improve
their negotiating positions. That has proved to be an effective strategy in
many cases. Even dominant health plans cannot do without the largest hospital
systems in their areas, especially when they employ many of the local
physicians.
According to a Kaufman Hall report, 90 hospital and health system deals were publicly announced in 2018. This was a decline from the 115 deals unveiled in 2017, but the average size in the revenue of sellers hit a high of $409 million.
The biggest provider mergers are staggering in scale. In February 2019, for example, Catholic Health Initiatives and Dignity Health formed a new organization called CommonSpirit Health, which has 142 hospitals, 150,000 employees and nearly $30 billion in revenues. The union of Chicago-based Advocate Health Care and Wisconsin’s Aurora Health Care in April 2018 created a giant with 27 hospitals and $11 billion in revenues. A month later, Atrium Health (formerly Carolinas Healthcare System) joined with Wake Forest Baptist Health to form a system with 49 hospitals and combined revenues of $7.5 billion.
The
Office of the National Coordinator (ONC) and the Centers for Medicare and
Medicaid (CMS) have proposed final rules on
interoperability, data blocking, and other activities as part of implementing
the 21st Century Cures Act. In this series, we will explore ideas
behind the rules, why they are necessary and the expected impact. Given that
these are complex and controversial topics are open to interpretation, we
invite readers to respond
with their own ideas, corrections and opinions.
Interventions to Address Market Failures
Many of the rules proposed
by CMS and ONC are evidence-based interventions aimed at critical problems that
market forces have failed to address. One example of market failure is the long-standing inability for health care
providers and insurance companies to find a way to exchange patient data. Each
has critical data the other needs and would benefit from sharing. And, as CMS
noted, health plans are in a “unique position to provide enrollees a complete
picture of their clams and encounter data.” Despite that, technical and
financial issues, as well as a general air of distrust from decades of haggling
over reimbursement, have prevented robust data exchange. Remarkably, this happens
in integrated delivery systems which, in theory, provide tight alignment between
payers and providers in a unified organization.
With so much attention
focused on requirements for health IT companies like EHR vendors and providers,
it is easy to miss the huge impact that the new rules is likely to have for
payers. But make no mistake, if implemented as proposed, these rules will have
a profound impact on the patient’s ability to gather and direct the use of
their personal health information (PHI). They will also lead to reduced
fragmentation and more complete data sets for payers and providers alike.
Overview of Proposed CMS Rules on Information
Sharing and Interoperability
The proposed CMS rules
affect payers, providers, and patients stating that they:
Require payers to make
patient health information available electronically through a standardized,
open application programming interface (API)
Promote data exchange
between payers and participation in health information exchange networks
Require payers to provide
additional resources on EHR, privacy, and security
Require providers to comply
with new electronic notification requirements
Require states to better
coordinate care for Medicare-Medicaid dually eligible beneficiaries by
submitting buy-in data to CMS daily
Publicly disclose when
providers inappropriately restrict the flow of information to other health care providers and payers
Today the notion that health is a preferred state of being, rather than a set of disconnected functions or services, is increasingly being embraced. A recent JAMA article promoted a health measurement system called the “flourishing index” focused on 6 key domains: happiness and life satisfaction, physical and mental health, meaning and purpose, character and virtue, close social relationships, and financial and material security.
Dr.
Gro Brundtland, former director-general of the World Health Organization, wrote
in the World Health Report 2000 that
“The objective of good health is twofold – goodness and fairness;
goodness being the best attainable average level; and fairness, the smallest
feasible differences among individuals and groups.”
In
the age of Trump, with forced separation of immigrant mothers and children,
criminalization of abortion, and purposeful obstruction of enhanced access to
health care for vulnerable populations, it becomes impossible to ignore a
significant modern-day truism. Health is profoundly political.
Health is a collection of resources unequally distributed in society. Health’s “social determinants” such as housing, income, and employment, are critical to the accomplishment of individual, family, and community well being and are themselves politically determined.
Apparently, podcasts are new, all the rage and minting billionaires every day! So, of course, THCB had to have its own podcast, and here it is: HardCore Health
Now I’ve been doing “podcasts” (otherwise known as audio or video interviews) on THCB since before people actually had iPods (remember those, kids?). But apparently these days any punter can do an interview, call it a podcast and shove it up on Spotify. Hardcore Health is going to be a little bit different…
Hardcore Health will feature multiple guests, topics, and interludes brought to you by many co-hosts starting off with Jessica DaMassa and me. We’ll embed some (familiar) tidbits into the show including: Health in 2 Point 00, THCB Spotlights, and the WTF Health Show as well as some newer segments, including banter sessions between guests & rant sessions from health care experts. This first episode features Brian Kalis, Accenture’s “post” Digital Health expert & Niko Skievaski from Redox, and a little more.
I hope you enjoy our first episode below!
Matthew Holt is the founder and publisher of The Health Care Blog and still writes regularly for the site.
The high cost, low quality and systemic inequities of the U.S. healthcare system have been the impetus for its redesign. Our healthcare system is now controlled by Consolidated Healthcare institutions, Insurance companies, Pharmaceutical companies and Health Information Technology companies (CHIPHIT complex). The CHIPHIT complex, along with the Federal Government, will create and control our future healthcare system. Ominously missing from this list are independent healthcare policy experts, independent healthcare providers and members of the general public.
Historical precedents have demonstrated that the CHIPHIT complex is
incapable of creating the healthcare system we need.
Thus, if we hope to build a low cost, high quality, egalitarian
healthcare system, physicians and their professional organizations must take an
emphatic stand against the CHIPHIT complex today.
Consolidated Healthcare Institutions
There are innumerable mandates which make running a small medical practice very difficult. As a result, many younger physicians will no longer attempt to start a new medical practice and existing profitable practices, which are looking to off- load their regulatory burdens, are being acquired by large healthcare institutions and private equity firms.
While these consolidated healthcare institutions vocalize their desire
to improve our healthcare system, many enforce a uniformity on the practice
environment which belies the reality of patient care; that there is no “best” practice model, nor are there
information technology tools which work well for all physicians. This imposed
uniformity stifles physician innovation, which is a necessary precondition to
improve our healthcare system.
Health insurance companies are standing
in the way of many patients receiving affordable, quality healthcare. Insurance
companies have been denying patient claims for medical care, all while increasing
monthly premiums for most Americans. Many of the nation’s largest healthcare payers
are private “for-profit” companies that are focused on generating profits
through the healthcare system. Through a rigorous approval/denial system, health
insurance companies can dictate the type care patients receive. In some cases,
this has resulted in patients foregoing life-saving treatments or procedures.
In 2014, Aetna, one of the nation’s leading healthcare companies, denied coverage to Oklahoma native Orrana Cunningham, who had stage 4 nasopharyngeal cancer near her brain stem. Her doctors suggested she undergo proton beam therapy, which is a targeted form of radiation that can pinpoint tumor cells, resulting in a decrease risk of potential blindness and other radiation side effects. Aetna found the study too experimental and denied coverage, which resulted in Orrana’s death. Aetna was forced to pay the Cunningham family $25.5 million.
In December of 2007, Cigna Healthcare, the largest healthcare payer in Philadelphia, denied coverage for Nataline Sarkisyan’s liver transplant. Natalie was diagnosed with leukemia and had recently received a bone marrow transplant from her brother, which caused complications to her liver. A specialist at UCLA requested she undergo a liver transplant, which is an expensive procedure that would result in a lengthy inpatient hospital stay for recovery. Cigna denied the procedure as they felt it was “too experimental and outside the scope of coverage”. They later reversed the decision, but Nataline passed away hours later at the University of California, Los Angeles Medical Center.
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking, and other activities as part of implementing the 21st Century Cures Act. In this series, we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions. In part five of this series, we look at how competition unlocks innovation, and how the proposed rules may disrupt the balance between innovation, intellectual property (IP), and supporting business models.
____________
The recent publication of proposed rules by ONC and CMS set off a flurry of activity. In anticipation of their implementation, the health care industry is wrestling with many questions around business models. What practices inhibit competition and innovation? How do we balance the need for competition while protecting legitimate intellectual property rights? How can vendors ensure profit growth when pricing is heavily regulated? In this article, we will examine how competition unlocks innovation and the possible disruptions the proposed rules may bring for innovation, intellectual property (IP) and supporting business models.
Unlocking Innovation
via Competition
In most markets, innovation is driven forward by competition. Businesses compete on equal footing, and their investment in R&D drives innovation forward. Innovation in health care has been dramatically outpaced by other markets, leading to an urgent need for both disruptive and evolutionary innovation.
What is inhibiting health care innovation? The rules identify a combination of tactics employed in health care that restrict the free flow of clinical data, such as:
NDAs
Confidentiality Clauses
Hold-harmless Agreements
Licensing Language
These tactics slow innovation by contributing to an
environment where stakeholders resist pushing the boundaries — often because
they are contractually obligated not
to. The legislation and proposed rules are designed to address the ongoing
failure of the market to resolve these conflicts.
As the rules are finalized, we will continue to monitor whether
the ONC defines these practices as innovation stifling and how they will
implement regulations — both carrot and stick — to move the industry forward.
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