Last Month in Oncology with Dr. Bishal Gyawali: April 2019

Last Month in Oncology with Dr. Bishal Gyawali: April 2019


Keynote speech on the JAVELIN not going far enough to improve survival

The treatment landscape for metastatic renal-cell carcinoma has changed dramatically with the introduction of immunotherapies. Unfortunately though, we are promoting combinations over single agents without having much idea of added benefit of each drug. This is an important issue because when we combine two drugs, the only thing we are certain of are the added toxicities. PD-1 inhibitor nivolumab had improved OS when given in second line, however nivolumab was tested in combination with ipilimumab (not as a nivolumab monotherapy) in the first line trial. Now, pembrolizumab and avelumab have followed suit, although their combination partner was axitinib – a VEGF inhibitor. The control arm was sunitinib for both of the trials of pembrolizumab plus axitinib (KEYNOTE 426) and avelumab plus axitinib (Javelin 101). This is a little surprising because we are testing A B versus C, where both A and B haven’t been approved for the given setting – axitinib was approved for RCC in second line. Both these combinations improved PFS versus sunitinib but only the pembrolizumab combination has shown improved OS. However, I have doubts about the contribution of axitinib to these results. What would the outcome be if pembrolizumab alone is followed by sunitinib in second line? It is important to note that only one third of patients who discontinued sunitinib received PD-1 inhibitor subsequently in the KEYNOTE 426 trial. The important question for patients and clinicians would be to consider a survival difference had most of these patients received a PD-1 inhibitor subsequently. As for avelumab, the JAVELIN trial hasn’t reached as far as pembrolizumab and nivolumab have reached: The OS benchmark – so let’s reserve this combination until we see that benefit.

Have we successfully landed on the COMET?

We should remember that this combo-mania with PD-1/PD-L1 inhibitors may also backfire. Previously, the RCTs of nivolumab and pembrolizumab combos were halted in multiple myeloma for higher deaths in the combo arms. Another RCT IMblaze 370 also reports that atezolizumab, alone or in combination with cobimetinib, failed to improve survival versus regorafenib in patients with metastatic colorectal cancer.  This time again A B failed versus C although C in itself is a drug with very marginal benefits in this setting. Also, I don’t understand testing A plus B combo when both A and B are unapproved for the disease.

SABR-COMET was an open label phase 2 RCT which tested if the use of stereotactic ablative radiation therapy (SABR) in the treatment of oligometastases (up to 5) improved survival. Among 99 patients randomised 2:1 to SABR plus standard care or standard care alone, the median OS was found to have improved dramatically by 13 months in the SABR group (41 v 28m, HR 0.57, p = 0.090). The authors conclude appropriately that “Phase 3 trials are needed to conclusively show an overall survival benefit.” I have no criticism against this study. However, I have criticism against some top experts claiming that this trial is already practice changing. No, this is a phase 2 trial whose objective was to determine if this intervention was worth testing in a phase 3.  The trial is positive, so the appropriate conclusion is “let’s test this in a phase 3 trial”, not “let’s change practice today”. It is also worth noting that the intervention had a 4.5 percent treatment-related mortality rate! We should never jump to conclusions, and kudos to the authors for concluding appropriately in the report of this public-funded RCT.

You may want to imagine how a similar RCT may have been published had it been an industry-sponsored drug trial. Well, you don’t need to imagine hard because we already have an example. In this partially industry-funded phase 2 RCT of regorafenib in 42 patients with relapsed metastatic osteosarcoma, the conclusion reads: “Regorafenib should be considered a treatment option for patients with relapsed metastatic osteosarcoma”. Guess what the results were to enable such a conclusion? The gain in PFS (primary endpoint) was less than 2 months. And the OS is in fact…wait for it…less in the regorafenib arm than the placebo arm by more than 2 months with a hazard ratio of 1.26 (95% CI, 0.51-3.13)! Can you now see how bias creeps in even in high-profile journals? SABR-COMET, a public-funded randomised phase 2 of 99 patients with both an OS endpoint and an OS difference of more than a year concludes (appropriately) that we should test the intervention in a phase 3 trial, while an industry-funded phase 2 RCT of a drug in only 42 patients with a PFS primary endpoint concludes that the drug should be considered a treatment option, despite the benefit in PFS being less than 2 months – but the detriment in OS (although not significant) being more than 2 months. I’m puzzled by the need to sugarcoat these results, especially on the background of olaratumab’s recent failure to improve OS in phase 3 despite showing improved OS in phase 2 in patients with soft tissue sarcoma. Speaking of conclusions based on phase 2 trials, a trial reports that “administration of nab-paclitaxel plus gemcitabine-cisplatin may prolong survival vs administration of gemcitabine-cisplatin alone for the treatment of advanced biliary cancers”. You, like me, may be wondering why test nab-paclitaxel instead of the much cheaper paclitaxel. Well, this trial was funded by Celgene. So it may not come as a surprise to you at all that this was a single arm trial and that “versus” in the previous statement was comparison to historical controls. Thankfully though, they are testing this in a phase 3 RCT.

The time to study metastatic cancer survivorship was yesterday

In one of the most poignant pieces on cancer survivorship written by two cancer survivors, we realise how the oncology community has forgotten the needs to address quality of life issues of metastatic cancer survivors in our enthusiastic quest of chasing marginal gains in oncology. The authors poignantly describe the various issues including hope, financial toxicity, psychosocial needs, caregiver issues etc. that trouble metastatic cancer survivors. Although we can be proud that we now have millions of cancer survivors living long term, we can’t continue to ignore their issues in research and clinical practice. The best time to study metastatic cancer survivorship was yesterday, the next best time is today.

Let me take a selfie

Is it ok to provide full approval to cancer drugs on the basis of non-inferiority trials especially if these drugs don’t offer any other benefits such as ease of administration, lower cost etc to justify the non-inferiority design? I discuss these issues on the background of recent approval of lenvatinib in hepatocellular cancer based on non-inferiority trial in a JAMA Oncology viewpointwritten with Dr. Aaron Kesselheim.

Dr. Gyawali is a research fellow at Program On Regulation, Therapeutics And Law (PORTAL) at Brigham and Women’s Hospital/Harvard Medical School. The opinions expressed herein are his own. This post originally appeared on ecancer here.

THCB Spotlights | Accenture: Brian Kalis, Managing Director of Digital Health

THCB Spotlights | Accenture: Brian Kalis, Managing Director of Digital Health

Accenture’s Brian Kalis, catches us up to speed on some of the survey work and analysis the consulting giant has been working on. In particular, Accenture is seeing a generational divide amongst Baby Boomers & the Millennials/Generation Z’s, the latter of which want to consume health care in both traditional & non-traditional ways – a hybrid of technology and older models of care.

For more watch Matthew’s interview with Brian above.

One Physician’s Frustrations of Practicing Amidst the CHIPHIT Complex and Implications for the Future of the U.S. Healthcare System

One Physician’s Frustrations of Practicing Amidst the CHIPHIT Complex and Implications for the Future of the U.S. Healthcare System


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.

If the consolidated healthcare institutions want to maximize the
probability of improving our healthcare system, they should encourage their
physicians to innovate, they must abandon their drive toward practice
uniformity and they need to defer all practice related decisions, including the
selection and design of information technology tools, to the professional
judgment of the relevant healthcare

Insurance Companies

Health Insurance companies tell their patients which primary care
physician and specialists they may consult. For many patients, lifetime
continuity of care is no longer possible and is a cause for anxiety for some
elderly and chronically ill patients.

Insurance companies tell physicians which tests they may order and which medications they may prescribe. As a result of the restrictive formularies, physicians are not infrequently required to use an “approved” medication even if they believe the patient would be better served with a non-formulary alternative. While it is possible to “appeal” for an exemption, many physicians have been so beaten down by serial and irrational denials that they have changed their practice patterns against their own professional judgement.

Several years ago I needed to obtain an emergency head CT scan for a patient who had “the worse headache of my life.” As the CT required a “prior approval,” I called the
insurance company and was told the CT was “not indicated.” I explain to the insurance company
representative (who lacked the clinical training to make such a decision) that
if the insurance company did not approve the CT scan, I would send the patient
to the ER where the insurance company will incur both the cost of an ER visit
and the cost of an emergent head CT scan. The insurance company representative
said, “OK, order the CT
scan and if it is abnormal we will pay for it.” One can only experience events like
this so many times before one becomes disillusioned and reluctant to engage
with insurance companies.

While many have assumed that some health insurance companies have prioritized  their own financial bottom line ahead of the healthcare needs and fiduciary obligations to their patients, this illegal business model was definitively illuminated by Judge Spero’s ruling in Wit v. United Behavioral Health.

Pharmaceutical Companies and Pharmacy Benefit Managers
The pharmaceutical industry has blocked the expiration of patents on
brand-name medications thus delaying the creation of inexpensive generics.

They have used legal loop-holes to acquire inexpensive generics and turned them into non-generics, which allows them to increase the price orders of magnitude. URL Pharma converted colchicine to a non-generic medication and then increased the price by more than 5,000%.

The pharmacy benefit managers (PBM) aggregate the purchasing power of multiple insurance companies giving them the market strength to (theoretically) lower drug prices. Nevertheless, the cost of medications continue to increase faster than the rate of inflation and health policy experts have begun to implicate the PBMs as a contributing factor to the high cost of pharmaceutical agents. For example, the price of a vial of Lantus insulin has increased 300% in the last decade despite the fact that it is exactly the same medicine which is being sold in the same container.

Health Information Technology Companies

The electronic health record (EHR) vendors have inserted themselves in the middle of the exam room and now have an inappropriate amount of influence on the interaction between a patient and their physician. In the exam room, physicians have to “click” on clinically irrelevant buttons in the EHR. The poor design of EHRs force physicians to spend two hours entering data into the EHR, much of it clinically irrelevant, for every hour of face-to-face patient care, a massively inappropriate use of a physician’s skill set.

While there have been successful EHR implementations, sadly, that is not
universally the case. EHRs do have an important role in our health care system
but they are not the panacea the EHR vendors claim. They are simply one tool of
many which can help physicians, if properly designed, to provide care to their

As a result of my decades long experience creating an EHR, I am certain
that EHRs would be far more useful to physicians if the person who has the
ultimate authority over all EHR design/implementation decisions:

  1. is required to use the EHR on a daily basis
  2. has deep knowledge about clinical medicine
  3. has some experience in computer programming
  4. has an in-depth understanding about information technology and
  5. is committed to evidence based medicine while acknowledging its

Physician Burnout

The accumulation of the aforementioned assaults on the physician’s professional judgement has resulted in “physician burnout,” which is “a long-term stress reaction characterized by depersonalization, including cynical or negative attitudes toward patients, emotional exhaustion, a feeling of decreased personal achievement and a lack of empathy for patients.” It is a prime cause of physicians prematurely ending their clinical careers, reduces the quality of healthcare provided and increases patient mortality. I know several physicians who had previously committed large amounts of time trying to improve their healthcare system but have since withdrawn their involvement because “nothing ever changes.”

Dangers of the CHIPHIT Complex
The CHIPHIT complex, in conjunction with the Federal Government, have
created a healthcare system which undervalues direct patient care and
overvalues clinically irrelevant documentation. They institute roadblocks which
thwart physician innovation and adversely impact our ability to provide
healthcare. They are the cause of physician burnout and the reason many
physicians, nurses, pharmacists and CMOs (personal anecdote) are dissatisfied
with the current design of our healthcare system.

In President Eisenhower’s farewell address, he said “We must guard
against the acquisition of unwarranted influence … by the military-industrial
complex…” The U.S. healthcare system rivals the size of the
military-industrial complex and the CHIPHIT complex already has an
inappropriate amount of influence over our healthcare system. If we choose to
ignore this precedent, our healthcare system will continue to be dominated by
the CHIPHIT complex for many decades into the future and that will prevent us
from obtaining the healthcare system we need.

The primary goal of the CHIPHIT complex is to maximize their revenue, as
it should be in a free market economy. If we want their primary goal to be the
optimization of our healthcare system then the laws which govern the CHIPHIT
complex must be changed – an unlikely outcome in today’s political climate.

As the CHIPHIT complex is incapable of building the healthcare system we
need, we must look beyond the CHIPHIT complex for a mechanism to repair our
defective healthcare system.

A Potential (Partial) Solution

Fortunately, there is objective data which shows us how to solve some of our healthcare system’s failures. As was discussed in the 2014 Robert Wood Johnson Foundation report “Time to Act: Investing in the Health of Our Children and Communities,” “The key to better health does not lie primarily in more effective health care.” We need to move healthcare out of our healthcare institutions and into the communities that need help. We must invest in our youth, in those who are educationally, socially and economically disadvantaged. In doing so we will reduce the prevalence of obesity, cigarette use, other unhealthy behaviors and societal inequities which disproportionately afflict segments of our society and drive up healthcare and avoidable social expenditures. This model has already been implemented in other countries and is objectively more effective than our current healthcare system.

If we hope to have the healthcare system we need, society must redirect resources away from the CHIPHIT complex and into the hands of those who unambiguously prioritize a holistic, high quality, low cost and egalitarian healthcare system.

Hayward Zwerling is a practicing physician who has created ComChart EMR.

Private Health Insurance Organizations Shouldn’t Dictate Quality of Care

Private Health Insurance Organizations Shouldn’t Dictate Quality of Care


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.

In another case, Brian Callister, Associate Professor of Internal Medicine at the University of Nevada, made a request to transfer two high-risk patients to local hospitals in California and Oregon for procedures not performed at his hospital. In both situations, the insurance companies denied the transfer requests as the procedures would have been too costly. Instead, they suggested physician-assisted suicide, which would have been covered through the insurance.

The American Journal of Public Health recently published results from a study that found that an average of 45,000 annual deaths are associated with lack of health insurance coverage. In March of 2009, Billy Koehler died from cardiac arrest after the batteries died in his heart defibrillator. After being laid off, Billy lost his healthcare coverage. He was then denied coverage from several private insurance companies because of his pre-existing condition. eTaking a step in the right direction, the Affordable Care Act made it so that health insurance companies couldn’t refuse coverage to patients based on pre-existing conditions ( Moving forward, under the new Presidential Administration, several states seek to remove pre-existing condition protection in the Affordable Care Act.

Taking a moment to look at look at both sides, we can’t place all the blame on health insurance companies, as there have been several fraudulent claims sent in by providers and healthcare organizations. In July of 2018, Health Quest and Putnam Health Center (two New York-based health systems) were forced to pay the federal government $14.7 million to settle a healthcare fraud case for submitting ineligible and inflated claims. Health insurance companies have always informed patients they are able to appeal denied claims or coverage requests through the proper channels within company. Unfortunately, it’s not a simple task, as many patients are often bounced back and forth between departments and administrative staff with no answers in sight.  

Some individuals may think it’s best to simply go without healthcare coverage and take their chances. However, a recent study conducted at Harvard Medical School and Cambridge Health Alliance, found that uninsured, working-age Americans have a 40% higher risk of death than their insured counterparts. Instead, I suggest we adapt a version of the universal healthcare model. Many individuals have expressed concerns about the pitfalls of this plan, which include significantly long wait times to see a healthcare provider. I propose we use this plan as an outline and work to make it fit our American healthcare system—because our current system just isn’t working.

It’s unfortunate that, as of 2017, our nation’s healthcare spending increased to about 3.5 trillion, yet patients are not able to receive lifesaving treatment. Access to affordable healthcare coverage to receive quality care shouldn’t be a pipe dream of public health professionals.

Lynly Jeanlouis is a Quality Improvement Healthcare Professional working in Manhattan.

A Millennial Doctor’s Experience with Industrial Medicine

A Millennial Doctor’s Experience with Industrial Medicine


A survey of 200 physicians under the age of 35 showed that 56% reported unhappiness with the current state of medicine. That number didn’t seem surprising to me at first. I was not particularly “happy” at the time of reading this survey either.

I’ve aspired to become an
oncologist for as long as I can remember. In oncology, despite my inability to
cure, I can always try to heal. I form connections with patients and their
families as they embark on a journey that is quite often their last. I learn
from my patients as much as, and at times more than, they learn from me.

But all of this is overshadowed by
a sense of heaviness that I frequently encounter as I enter the clinic room. That
sense of heaviness hits when a patient tells me of the time when they were placed
on a “brief hold” for more than half an hour in order to reach someone to get a
prescription refilled or reschedule an appointment. Or when their insurance refused
to cover the drug that I had prescribed to them. It is when I hear that clinic
visits or treatments are not scheduled due to insurance authorization delays. Or
when I’m asked about the cost of drugs and end up having to explain how nobody
really knows.

By the time I hear these stories,
the “allotted time” for the clinic visit is coming to an end. The emotional
burden and physical symptoms of my patient’s cancer diagnosis or chemotherapy
side effects often not adequately addressed.

I recall Jessica, a violinist who
has lived with metastatic breast cancer for 4 years, and whose disease has
progressed after multiple lines of chemotherapy. She was hospitalized with a
malignant pleural effusion that impaired her ability to breathe while playing
the violin. I discussed with her the option of enrolling on a clinical trial
after leaving the hospital.

“I am so glad you have clinical
trials here,” she replied ecstatically. “I’ve been asking about research
studies all over the state”.

The days went by and she had not
been scheduled to start on the investigational agent. “Why the delay?” I asked.
“We are awaiting authorization from her insurance company”, was the reply I

A couple of weeks later, Jessica’s pleural
effusion recurred and she started developing pain related to her bone
metastases. She underwent a pleurodesis procedure to prevent re-accumulation of
fluid. By then, her functional status had deteriorated substantially. She was no
longer eligible to participate in the clinical trial and decided to pursue
hospice care. She died several weeks later.

These stories are not uncommon. I have
seen many patients whose treatments are delayed because of administrative
barriers. In this example, and many others, the health system did not have the patient’s
care as their primary concern; a system that is algorithm-driven and blind to individual
human needs.

But at the other end of these
stories are the physicians. I will never forget Jessica, and countless others
who suffered because of a system that does not care about the individual. These
stories linger and create a sense of despondency with the medical system in
which I practice.

But why is this the reality of
medicine now? The short answer is because we surrendered our autonomy as
physicians and allowed administrators and third-party payers to take over. Industrial
healthcare was then born; a system that is designed and developed to deliver services
to patients while achieving maximum returns on investment for all parties
involved except the patients. Multiple stakeholders are involved, and each has
a goal of profiting off of the patient’s illness. During this industrial expansion,
the system has done two things. First, it limited physician autonomy –
checklists were created, time for clinic visits or procedures restricted, and
practice standardized.  Second, it left
patients with a full time job to attempt and navigate countless barriers in
order to maintain and/or improve their health. If you are reading this and have
ever been a patient, you will know exactly what I mean.

This relationship between physician
autonomy and patient care is the core of the medical profession, and it seems
to be the most severely damaged aspect of our current system. Take the
following example; oncologists are pressured to see 20-25 patients with
cancer/day. This limited time available for each patient makes difficult
conversations about prognosis even harder. In many cases, these physicians have
minimal control of their own schedule. The net result is decreased physician satisfaction
with their job when they have only 10-15 minutes with each patient, and by the
same token, patients rarely have a good understanding of their illness. And
yet, I have received emails that contain words such as “operational
efficiencies”, but have never received emails that contain words such as “kind
care” or “non-rushed care”.

Physicians functioning within a box eventually become dehumanized. Terms such as “provider” and “consumer” are commonly thrown around. And in the process, I find that physicians are questioning their purpose. Doctors and nurses are occupied with checklists to the point that they start seeing patients as objects; a room number or a diagnosis. “How is room 307 doing?” is a common question on rounds.

In the last decade, terms such as
“burnout” have become popular. Burnout is a manifestation of these aforementioned
ills. And instead of solving the root cause of the problem, physicians are
blamed and the burden placed on them to become more resilient. I find myself
commonly adjusting to mandates and rules rather than having a say in their
creation, implementation, or, dare I say, their elimination.

As I approach the end of my
fellowship and the beginning of my career as an oncologist, I think about how I
can make this experience better for myself and for my patients. Technology has
introduced methods for safer practice including medication reconciliation,
checking and rechecking orders, but folks who have no horse in the race are
harnessing this technology. Physicians on the frontlines who know what works
for them and for their patients are not involved in the design and implementation
of these technologies. Take the electronic medical record (EMR) for example; a
Twitter account  (@EPICEMRparody) was
recently created as a parody of the realities of clicking away on a screen
while the patient is sitting in the background. How did we get to that?

What seems obvious to me is that neither
patients nor the physicians are at the center of the equation. In order to
really care for patients, the system has to adjust to the patient and
physician’s needs, and not the other way around. It has to provide more
autonomy for physicians. Simultaneously, the system has to alleviate the burden
on patients. To minimize the time they spend interacting with the healthcare
system so they can live their lives instead of having their lives revolve around
their illness. These strategies have to start by putting humans first, and
genuinely caring. It means keeping open minds and ears to ideas. It means less

As things stand, physician turnover and replacement is increasing, and burnout has become the norm. Patient’s distrust in the healthcare system and physicians is at all-time high. In order to reestablish our purpose and the patient’s trust in us, we as both physicians and patients have to speak up. This is my attempt at speaking up.

Talal Hilal is a graduating hematology/oncology fellow at the Mayo Clinic in Arizona. He will be joining the hematology faculty at the University of Mississippi this summer, with a focus on lymphoproliferative disorders.

THCB Spotlights|Deven McGraw, CRO of Ciitizen

THCB Spotlights|Deven McGraw, CRO of Ciitizen

Deven McGraw is one of America’s best known health privacy lawyers, including a stint at HHS running the Office of Civil Rights. But now she’s a cool startup kid living in Silicon Valley and is the Chief Regulatory Officer at Ciitizen. Ciitizen is focusing on helping people collecting, organizing, and securely sharing their personal health data to improve their care, and was founded by Anil Sethi who previously founded Glimpse and sold it to Apple (where it is now the core of Apple’s Health records product).

For more details, watch Matthew’s interview with Deven below.

ONC & CMS Proposed Rules – Part 5: Business Models

ONC & CMS Proposed Rules – Part 5: Business Models
Grant Barrick
Dave Levin


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.

Protecting IP &

Health IT (HIT) companies must be able to protect their intellectual property (IP). And, the proposed rules agree. There are four general areas of IP:

  • Patents
  • Trade Secrets
  • Copyrights
  • Trademarks

How can health IT (HIT) companies compete and protect their IP
if we open the marketplace? The goal of the rules is to define what is
reasonable in IP protection and limit the tactics discussed above, saying:

…a developer is not permitted to prohibit or restrict
communications under the guise of copyright protection (or under the guise of a
confidentiality or non-disclosure obligation) when the communication in
question makes a use of the copyright material in a way that would qualify that
use as a “fair use.”

The rules seek a balance between the need for free-flowing
clinical data and IP protection. Further, the rules recognize that HIT
companies should be able to generate profits.

There are two different pathways to profitability:

  1. The ability to be profitable through pricing.
  2. The exploration of new business models that
    maximize profits.

While they extend the definition of information blocking to include, “any fee that is likely to interfere with the access, exchange, or use of EHI.” They also acknowledge the potential negative impact on innovation. They go on to note that vendors can charge fees, but the fees must be tied to actual costs. This is intended to promote competition and the free flow of clinical data while also minimizing opportunistic pricing (“rent seeking”) and ensuring reasonable vendor profitability.

It is a good first step that guarantees HIT vendors a profit
while encouraging clinical data exchange. However, it may not allow HIT vendors
the opportunity to earn the profits needed to invest in R&D, which is
necessary to promote innovation. HIT vendors may need to embrace new business

The Benefits of
Innovation in Other Sectors

Apple has defined the business model for the new millennium. They embrace an open model, where developers can freely (within the confines of terms and limitations) exchange data and it has flourished. Their App Store revenue has grown by 28% in recent years, outpacing the rest of the company despite lowering developer fees in 2016. This example shows that an open environment can help revenue growth. Moreover, if lower pricing means greater access to participation–the more open the environment is, the faster it can grow.

In moving to a more open environment, the market will have
access to far more data and insights, which is the goal of the proposed rules. Imagine
the analytics and insights an electronic health record (EHR) could give their customers
and developer partners, providing further value and strengthening all
relationships in the industry.

Or, look at Airbnb as a disrupter in the hospitality industry. They proved you can be successful without owning property — having more listings than the five largest hotel brands combined.

In health care, we can compare this to clinical data
ownership. It belongs to who it belongs to, and they can do with it as they
please. However, by enabling the marketplace, you make room for dramatic growth.

Next Steps for Health

The proposed rules have raised a lot of questions around
business models, innovation, and profitability. It will be interesting to see
how much-needed competition will impact innovation in health care and the role
free-flowing clinical data will play on that innovation. And, how these changes
will take place while guaranteeing the rights of HIT vendors to protect IP and

However, the proposed rules help us understand what the limitations and guide rails will be. If HIT looks outside of health care for inspiration, we may find that the open exchange of clinical data and healthy profits are possible while protecting IP.

Dave Levin, MD is co-founder and Chief Medical Officer for Sansoro Health where he focuses on bringing true interoperability to health care. Dave is a nationally recognized speaker, author and the former CMIO for the Cleveland Clinic.

Grant Barrick is the VP Marketing at Sansoro Health with decades of experience in guiding growth for health care companies in core and adjacent markets. He’s served in executive roles at 3M, MinuteClinic, Wolters Kluwer Health and ProVation. 

Pulling Care Out of Hospital—By Phone, Ambulance, and Good Ol’ House Calls.

Pulling Care Out of Hospital—By Phone, Ambulance, and Good Ol’ House Calls.


In the 20th century, hospitals completed their
transformation from the hospice-like institutions of the Middle Ages, into
large, gleaming centers of advanced medical expertise and technology that save
and improve lives every day. But an unintended consequence of hospitals’
dazzling capabilities is a staggering cost burden that’s proving toxic to the
American economy.

Today, hospital care accounts for approximately 33% of the US’ $3.5 trillion annual health care expenditures, according to CMS. The drivers of hospital costs are complex and hard to tackle, including (but not limited to) market consolidation that enables price hikes, heavy administrative burdens, expensive technology and patient usage patterns.

In The Innovator’s Prescription, Clayton Christensen et al. explained another important driver of high hospital care costs: conflation under one roof of business models designed to address very different needs—such as the need for diagnosis of unique, complex conditions and experimental treatments, versus that for highly standardized services (for instance, some surgical procedures). This common phenomenon makes optimization of either business model very difficult, and thus drives up overhead costs.

One solution to this seemingly intractable
problem is to make home and community the default locations for care, where in
many circumstances it can be provided less expensively, more conveniently, and
more effectively than in a hospital. Fortunately, business model innovation
toward this end is gaining traction.

Nemours Care Connect, a pediatric telemedicine program run by Nemours Children’s Health System’s Center for Health Delivery and Innovation, is one promising example. Available in seven states, the service links patients with clinicians via smartphone or laptop, (24 hours a day, 7 days per week) for virtual consultations concerning acute, chronic and post-surgical issues. As reported by Modern Healthcare, in a peer-reviewed study of the program conducted by Nemours using data from 1,000 patient visits between 2015 and 2017, 27% of parents said that they would have taken their child to an Emergency Department (ED) had the telehealth service not been available. Thus, the study estimates, the service saved the Florida health system more than $100 million in pediatric ED costs during that period.

The Centers for Medicare and Medicaid Services (CMS) is also promoting home- and community-centered care models, with programs like the new Emergency Triage, Treat and Transport (ET3) payment model.

people who could receive appropriate care at home or in the community call for
an ambulance to the ED because they don’t have awareness of, or access to,
other options; or someone calls an ambulance to the ED for them when they are
incapacitated. The ET3 model aims to address that by paying participating
ambulance suppliers and providers to take Medicare beneficiaries who call 911
to the most appropriate care site, whether the ED, a primary care provider or
an urgent care center; or to treat them on scene, supported by a qualified
health practitioner and telehealth as required. The agency hopes the program
will improve quality and reduce costs by helping patients access safe and
appropriate care, at the right time and place.

Finally, in an interesting reversal of the 20th century movement to centralize care in hospitals, home-based care is making a come-back. The Home Centered Care Institute (HCCI) was founded in 2014 to train and mentor physicians in providing high-quality primary care to chronically ill, medically complex and home-bound patients in their own homes; and leading institutions like The Cleveland Clinic and University of California at San Francisco have partnered with HCCI to help.

CMS is also supporting the trend with the Independence at Home demonstration project, an innovative service-delivery and payment-incentive model designed to improve quality of care and life for chronically ill patients, and reduce the need for expensive, institutional care. Approximately 10,000 chronically ill Medicare patients receive comprehensive primary care at home through the program, and it has driven over $50 million in care cost savings over three years.

As evidenced by the abovementioned programs, innovators across sectors are driving this shift in care locus from hospital to home and community, indicating broad understanding of its potential benefits, and great determination to realize them. But the shift poses great challenges for traditional hospitals that aren’t prepared for it, and might therefore resist it; and there’s still much work to do in developing and optimizing business models that enable the right care, at the right time, in the right place. Let’s hope the evolution happens faster than that of the hospital did.

Rebecca Fogg is a senior research fellow at the Clayton Christensen Institute, where she studies business model innovation in health care delivery, including new approaches to population health management and person-centered care.

THCB Spotlights:

THCB Spotlights: is a population health company that helps providers and insurers in their transition to a value-based care model. Arcadia is working with several of the Blues, Cigna, Beth Israel, and more. While it started as a consulting firm, in recent years Arcadia has raised over $40m from Merck, GE, and other corporate venture funds.

Listen to Matthew Holt’s interview with Sean Carroll, CEO of below.