Will COVID-19 accelerate or put the brakes on the move toward value-based payment? Christopher Chen, M.D., CEO of Miami-based ChenMed, says doctors will embrace value over volume as layoffs and work reductions hit hospitals and medical practices that depend on fee for service. Others expect a tendency to hit the pause button as payers and practices sort through the uncertainty stirred up by the pandemic.

Here are snapshots of four current value-based efforts:

of Massachusetts’ Alternative Quality Contract:

Lauded as one of the earliest and most successful value-based care programs in the country, the Blue Cross Blue Shield of Massachusetts Alternative Quality Contract (AQC) sets a global budget for patient care. In the now-familiar arrangement seen with ACOs, providers receive a percentage of the “savings” if they deliver care below budget and pay out losses if they exceed the budget.

“The program is a pioneer in encouraging providers to treat the whole person — the medical, behavioral and social needs of patients,” says Maria Perrin, chief growth officer of HMS, a population health and healthcare payment company in Irving, Texas. Perrin points to the 2019 study by Zirui Song, M.D., Ph.D., and colleagues AQC saved, on average, $461 per year per member. The study covered an 8-year period from 2009 to 2016.

The AQC was launched in 2009 as a development project by the Massachusetts Blues plan and providers in Massachusetts, a state with a recent history of experimentation and innovation in healthcare coverage and payment. The 2006 law that expanded healthcare coverage in Massachusetts —so-called Romneycare — was a forerunner of the ACA. The AQC program, which is itself a prototype for ACOs, now has more than 80% of Massachusetts providers participating.

“While the results of many value-based care programs are still developing and, in some cases, such as with CMS’ Hospital Readmissions Reduction Program, highly debated, the AQC is an example of a very successful VBC (value-based care) program with clear benefits,” Perrin says. “The AQC was also ahead of trends in recognizing the need for integrated care, addressing medical, behavioral and social determinants. Further, the structure of the AQC is one that does not require regulatory or legislative actions, so it can be adopted by other health plans and health systems with relative ease.”

2. Hospital Readmissions Reduction Program

The CMS Hospital Readmissions Reduction Program is a Medicare value-based program focused on reducing post-discharge readmission rates. Started in 2012 as part of the ACA, the program imposes financial penalties on hospitals with higher-than-expected readmission rates. Last year, 2,583 of 3,129 hospitals, or 83%, were penalized under the program. The penalty, which varies with the readmission rate, is collected by lowering the Medicare payment to hospitals. According to Kaiser Health News, the lower payments will cost the hospitals, collectively, $563 million during the 2020 government fiscal year.

Hospitals have objected to the readmissions program. But John E. Morrone, a partner in the healthcare department of Frier Levitt, explains that the program is intended to connect reimbursement to quality hospital care, prudent discharge planning and better coordination of care with post-discharge providers. The program is limited to several condition and procedures, including acute myocardial infarction, chronic obstructive pulmonary disease, coronary artery bypass surgery and total knee and hip replacements. “Those diagnoses lend themselves to frequent readmission due to poor discharge planning and/or poor post-discharge compliance with drug regimen, physical therapy and behavior modification (such as diet and exercise),” says Morrone. Conversely, he notes, multidisciplinary programs, chronic care management and remote patient monitoring are effective approaches to those conditions and procedures.

Moreover, there is good evidence that some relatively straightforward interventions are associated with fewer readmissions. For example, heart failure patients who are prescribed an ACE inhibitor or an angiotensin receptor blocker when they are discharged from hospital have lower readmission rates than those who don’t get such a prescription.

3. Oncology Care Model and its successor, Oncology Care First

The Oncology Care Model (OCM) is CMS’ most important value-based care payment program in oncology, and it is scheduled to be followed in 2022 by a successor program, the Oncology Care First (OCF) Model. Started in 2016, OCM is a voluntary program that CMS says currently includes 138 practices, down from close to 200 several years ago, and 10 payers. As with many value-based payment arrangements, the practices participating in OCM can earn shared savings if they beat certain financial benchmarks; downside risk, which involves paying a penalty if spending exceeds the target but also a chance at greater shared savings, is an option. The participating practices are also paid a Monthly Enhanced Oncology Services (MEOS) payment of $160 per patient for care coordination and other “care transformation” improvements, such as giving patients around-the-clock access to a clinician who has ready access to their medical services and some patient navigation services.

OCF nudges oncology payment further along toward capitation by combining payment for evaluation and management services and drug administration with the MEOS payment into a single prospective payment. CMS incorporated some other changes into OCF that are generally seen as advantageous to oncology practices, such as considering adjustments for expensive new therapies on a cancer-by-cancer basis instead of grouping them together.

OCM has received mixed reviews, but an evaluation of its first three performance periods that came out in May was quite damning. It found that OCM showed no overall effect on per-episode payments (the modest $145 per-episode decrease was not statistically significant) and little evidence that the program incentives led to less low-value care (some combination of higher expense and poorer outcomes) and more high-value care (lower expense, better outcomes). Moreover, during the first two pay periods, OCM ended up costing the Medicare program money because the small decline in per-episode payment was offset by what it paid out in MEOS payments and performance-based bonuses for beating the financial benchmarks.

Christopher J. Kutner, a partner at New York State law firm Rivkin Radler who represents managed care organizations and physician groups, says commercial payers want to expand value-based models to better predict the cost of care. But he also points out claim systems were designed for fee-for-service reimbursement. “It’s a drastic change and challenging for payers and providers to operate on a bundled case rate or episodic payment structure.”

“Success hinges on oncologists being incentivized and enabled to deliver high-quality care alongside measurable cost savings,” Kutner adds. “Cancer care is extremely expensive, so I am encouraged that there are some emerging opportunities that stakeholders must examine in order to realize value in today’s oncology reimbursement models.”

Between 30% to 40% of hospital inpatients (with or without diabetes) require insulin therapy during their stay. And despite its impact on health outcomes and the fact that it is largely preventable, hypoglycemia remains a very common occurrence. A study published by the Office of Inspector General shows that hypoglycemia is the third most common adverse drug event among Medicare patients.

Robby Booth, senior vice president of research and development and founder of Glytec, a company that sells insulin-dosing technology, says the new CMS hypoglycemia measure will gain a lot of buzz as the industry shifts more toward value-based care models.

“The program is designed to incentivize safer insulin management practices for hospitalized patients in order to reduce the incidence of insulin overdoses and hypoglycemia, which has a significant impact on the quality and cost of care,” Booth says. “The new CMS hypoglycemia measure (will) address these troubling statistics by incentivizing hospitals to implement clinical workflows that reduce the likelihood of hypoglycemia events.”

The measure hasn’t gone into effect yet, but it is in the final approval stages. The program is a stand-alone measure, but Booth expects that it will be followed up by another measure focused on hyperglycemia.

The program requires health systems to report severe hypoglycemia rates that are tied to a bonus payment. If the health systems don’t track the data, they lose the additional money.

“The agency will eventually use the collected data to establish a penalty for hospitals that report high levels of hypoglycemic events, which could add up to millions depending on the size of the health system,” Booth says.

®, is a freelance writer based in the Washington, D.C., area.

Articles

The work of moving away from fee for service is in progress. The results so far? Mixed.

Are we there yet? A look at 4 value-based care programs

Real-world evidence (RWE) is a buzzword, and there’s nothing that American healthcare likes more than the zzzzz of a good buzzword.

But the buzz of RWE has some substance to it. RWE research is changing how medications and medical devices are approved and paid for. It’s nipping at the heels of the randomized clinical trial that remains the standard by which all medical research is judged. And RWE proponents are covetously eyeing the mountains of data that patient Fitbits, Apple watches and other devices could produce.

Last year Pfizer used RWE to win expanded approval for its breast cancer drug Ibrance (palbociclib), adding male breast cancer treatment as an indication. The FDA accepted the analysis of data from electronic health records (EHRs) and medical databases as proof of Ibrance’s efficacy. The growing acceptance of RWE is due, in part, to former FDA commissioner Scott Gottlieb, M.D., who welcomed using data from outside of clinical trials.

Over the past four years, Jeff Morgan, a managing director at Deloitte Consulting LLP, has seen a significant increase in RWE in life sciences. Morgan, who leads Deloitte’s RWE unit, called ConvergeHealth, sees it as part of a trend of people becoming more engaged in their healthcare and the data associated with it. “There [are] a lot more patient data available than ever [before].”

RWE may have some financial advantages for drug developers. Traditional research, anchored in clinical trials, is becoming increasingly expensive. A study published in the March 3, 2020, issue of 

 investigated the costs of developing 63 of 355 new therapeutic drugs and biologic agents that the FDA approved between 2009 and 2018. The researchers calculated that the research cost per product was $985 million, a figure that includes expenditures on failed trials. Experts debate estimates such as those, and there are always questions about which costs should be included. But no one would question that drug development is an expensive proposition.

Proponents of RWE say it will yield information that is both more targeted and more thorough than the evidence that clinical trials can provide. But that doesn’t mean RWE research is easy to do — or inexpensive, notwithstanding the relative cost of the randomized trial. What’s more, EHRs and insurance claims may contain a wealth of information, but neither are designed for medical research. And if wearable devices were to live up to merely half of their hype, even more data would come pouring into the mix. Collecting, organizing and understanding data requires skill, time and money, and many current computer systems just aren’t up to dealing with that data firehose.

Today RWE is predominantly used by the pharmaceutical industry to help demonstrate a product’s effectiveness to both prescribers and payers when it is used outside a controlled clinical trial. Patients who are enrolled in clinical trials of a drug may differ from those who are prescribed a medication after it has been on the market, notes Morgan. Those patients are often older than the study participants, and they tend to have more comorbidities.

RWE has been used for trial design, trial recruitment and marketing insights, says Dan Riskin, M.D., CEO of Verantos, an RWE technology company in Menlo Park, California. “None of these uses makes clinical assertions, saying one drug is better than another,” or that treatment with drug A will result in 20% better outcomes, he says. He considers the use of RWE to make clinical assertions as an “advanced use” case, when investigators pull data from multiple sources including EHR unstructured data, wearables, and the like. Advanced RWE might be used to expand indications and provide evidence-based results for use in value-based care, says Riskin, whose company provides these types of services.

A 2018 McKinsey & Co. report on RWE said that pharmaceutical companies have entered a second phase of RWE research that involves using it in a more integrated fashion. Companies have created centralized RWE teams that are often situated in their medical affairs departments. But McKinsey said there is still a problem in the industry of RWE expertise being scattered throughout the companies.

In addition to companies wanting other methods to prove safety and efficacy, payers are eyeing RWE because of drug costs. “The pressure to demonstrate the value of the product is of the highest importance,” says Morgan. “We will see a transformation in the reimbursement model from the traditional price-per-pill model. We’re seeing a lot of adoption and experimentation of value-based pricing.” And RWE research is critical to value-based pricing because it reveals the outcomes a drug produces once it is “in the wild” and on the market, in contrast to the tightly controlled environment of a clinical trial.Many value-based contracts hinge on whether there is a significant difference between the results a drug produced in clinical trials and those it produces in a particular payer’s population.

The amount of data that can be collected on patients is exploding. In some cases, the quality of the analysis is not keeping pace with the quantity of the data. It was simpler with “old school” RWE that relied on claims data, which Riskin says have their virtues. They’re readily available, and the databases include millions of people. But, he says, “[The data are] not very accurate. [They’re] not very rich.”

The FDA made great strides in collaborating with industry to arrive at an understanding of quality RWE. “If you look at their most recent framework in RWE, data validity, it’s trying to get at what is believable,” Riskin says. It’s a difficult task, he continues, one that requires “rich” data sources that include the narrative sections of doctor reports, representing what he says are 80% of the EHRs. According to Riskin, some large oncology companies are including that narrative data. “It’s rich information but it’s an expensive version of RWE.” The data must be moved and extracted, enriched and then tested for accuracy.

Although medical records data aggregators aren’t new, says Morgan, “we’re seeing a lot of experimentation with unstructured data and how you curate that.” Data curation includes machine learning and natural language processing to extract data from the written or typed narrative. Some organizations hire armies of human abstractors to manually abstract the data, he says. “There is no perfect solution.”

Better data access and formatting would be welcome, but each data set does what it’s supposed to do, says Riskin. “Claims data is perfectly situated for decisions on claims reimbursement. It’s not designed to help someone run a study,” he says. Doctor narratives are intended to be a quick reference to the patient’s important problems and what has been done to address them. A researcher would want to know more about the patient’s medical conditions, what was prescribed or tried before, and the doctor’s thought process for choosing one treatment over another.

Data are often messy, but those with expertise in knowing how to control for certain parameters or conditions can arrive at some accurate inferences, Morgan says. But there are plenty of pitfalls. Riskin points to standardized data fields, such as checked boxes, as an example. Consider when patients with cancer or heart failure are asked whether they smoke. If only 10% of smokers accurately mark the box for positive smoking status, is it fair to treat these boxes as valid data, Riskin asks. “I’ve seen entire models made on that one field where an engineer thought it was (accurate) because they checked the box.” But peer reviewed articles show that for conditions such as cancer and heart failure, the rate of filling out that box correctly is less than 50%.

Each type of medical information provides a piece of the puzzle. Morgan says there’s growing interest among RWE researchers in finding ways to link the data sources at the patient level by, for example, matching up claims data and health records that would weave together clinical and economic information. Those links can also be to national registries and patient-reported outcomes. “This is a situation where advanced RWE has a lot of room to grow,” says Riskin. With so much information available, it has to be done the right way, with a high-quality protocol, institutional review board approval when necessary, and compliance with patient privacy rules.

The FDA is still working on its guidance for RWE. A 2018 framework established some ways to evaluate RWE in support of new drug indications or post-approval study requirements, but the agency expects to issue a more complete guidance for RWE in the next year, says Riskin. The guidance will, no doubt, be influential in setting expectations for RWE. Still, researchers, drugmakers, clinicians and payers will probably be battling it out over RWE and the quality of the evidence it produces. Making those assessments may start from the perspective of evaluating studies of variable quality, and determining what is believable and what isn’t, according to Riskin. “(Verantos) put a stake in the ground to decide what we think is believable,” he says of his company. “We are very happy that regulators are now involved. They make it their business to determine what is believable.” For Verantos, a quality RWE study has a protocol measuring data accuracy and ensuring minimum requirements for that accurate measurement. With that, “you can create a high-quality study. You will have to do a lot to achieve that.”

RWE research may vary with the study’s objective. “The FDA’s term is ‘fit for purpose.’ It means that depending on the purpose, that determines what the validity of the data is to be,” says Riskin, noting that the data required for marketing insights are not the same as those required for regulatory purposes.

In the next few years, Morgan anticipates a massive shift in use. “There is great promise in these data, which can drive efficiencies in research and development. We can design trials that are more patient-centric, to decrease the burden on patients.”

In addition to EHRs, the data for RWE research will come from daily at-home measurements, such as heart and respiration rates. “It’s just going to help start answering questions that a few years ago you couldn’t answer,” Morgan says. Instead of an EHR providing specific patient information a dozen times a year, or less, at visits, the information could be streaming daily. That will strain current information systems; most are not yet set up to receive this data volume. Healthcare organizations will need to move from on-premise legacy systems to cloud systems.

As cloud-based platforms are continually adopted, the data will be analyzed by more than just data scientists, says Morgan. He explains that data analytics are being democratized by increasingly accessible technology, allowing more stakeholders to work with them.

The future involves providing therapies targeted for an individual’s situation. If a 45-year-old woman has hypertension and a history of diabetes, “I want to know what works well for other people like her,” Riskin says. That may be in the future, but that’s where this is heading, he says.

Can data mined from EHRs match that from the gold standard, randomized clinical trials? 

Real-World Evidence: A Reality Check

About six million Americans are currently living with Alzheimer’s disease, and it is now the sixth leading cause of death in the U.S. According to several estimates, the number of Americans living with the condition will almost double by 2050, partly because of the demographic bulge of baby boomers entering their oldest years.

Andrea Pfeifer, Ph.D., CEO and co-founder of AC Immune, a Swiss biotech company that has several Alzheimer’s treatments in development, says dementia is one of the greatest challenges in healthcare.

“Globally, there is a new case of dementia every three seconds, adding up to around 50 million people worldwide, and the global cost of dementia stands at about $1 trillion — and we still don’t have an effective treatment or cure.”

By some accounts, the cupboard is bare because Alzheimer’s researchers have been going after the wrong target. For years, the prevailing theory about the disease has implicated accumulation of beta amyloid plaques in the brain as a primary cause. But agents targeting beta amyloid have fizzled in clinical trials. Researchers — and drug developers — have been forced to reconsider the hypothesis.

Mesfin Tegenu, M.S., R.Ph., president of PerformRx, a PBM in Philadelphia owned by AmeriHealth Caritas, says researchers are now eyeing other targets for treatment. “One such target is the tau protein, which is believed to be integral in the formation of (neurofibrillary) tangles seen in the brains of individuals with Alzheimer’s disease,” he says. The “tauists” have been debating “beta amyloidians” for decades, and beta amyloidians have had the upper hand until recently, particularly with respect to treatments that made it into clinical trials. But there is new interest in tau as a target and in February of this year, 650 people attended Tau2020 in Washington, D.C., a global conference devoted to “taupathies.”

But the turn to tau hasn’t meant a complete about-face on beta amyloid. In fact, the most-watched Alzheimer’s agent right now is Biogen’s aducanumab, a monoclonal antibody that targets beta amyloid. Despite some negative trial results, which Biogen interprets differently, the Boston-based company has forged ahead with seeking FDA approval for aducanumab. And the agency has put aducanumab in its “priority review” approval category, so there should be a decision on whether it is approved or not in March 2021.

Biogen’s aducanumab push is occurring against a backdrop of disappointing news this year about monoclonal antibodies that target beta amyloid. Most conspicuously, investigators announced that solanezumab, a monoclonal antibody, had faltered in a late-phase trial. Results showed no improvement in patients in a composite score of four different cognitive tests.

Gantenerumab, an antibody designed to degrade beta amyloid plaques, was tested in the same trial as solanezumab and, like solanezumab, it also didn’t pass muster with respect to the primary outcome of improved results on cognitive tests. However, other results suggested it still has some promise, and patients in the original trial were invited to participate in an continuing open-label extension.

Jeffrey L. Cummings, M.D., Sc.D., a research professor at the University of Nevada School of Integrated Health Sciences, Las Vegas, and director of the Chambers-Grundy Center for Transformative Neuroscience, says that Alzheimer’s clinical trials over the past five years have shown a “progressive emphasis” on targets other than beta amyloid, including inflammation, synapse and neuronal protection, and vascular factors. Cummings also notes a marked growth in repurposed agents.

Pfeifer, at AC Immune, highlighted semorinemab, an anti-tau antibody that her company is developing in partnership with Genentech, when discussing the products her company has in its pipeline. 

“Tau protein is mostly present in neurons and functions as a component of the cytoskeleton inside the cells and is involved in axonal transport,” Pfeifer explains. “Misfolded tau protein aggregates in AD and other tau-related neurodegenerative diseases (for example, progressive supranuclear palsy, frontotemporal dementia and others). The progression of tau pathology throughout the brain is closely associated with the onset and progression of cognitive decline, underscoring the importance of tau-targeted therapies.”

 and after earlier version of this story appeared in the September print issue of the publication, AC Immune and Genentech announced negative results from a high-profile phase 2 trial of semorinemab called the Tauriel Phase 2 trial. The drug failed to meet its primary endpoint and two secondary endpoints, according to an 

dated September 23. The headlines about the drug described it as a flop and cast tau as another off-base target. "Blocking tau appears to be just as fruitless as clearing amyloid buildup when it comes to helping Alzheimer's disease patients," was the first line of the 

 story about the semorinemab results.  Pfeifer was quoted in the prepared statements as saying the news was "surprising and disappointing," but she also spoke of the company's diversified approach to Alzheimer's.

The beta amyloid versus tau divisions may be fading. Pfeifer says opinion leaders in Alzheimer’s have started to float the idea that combination therapies are going to be needed in much the same way they are used to treat HIV, cancer and other diseases.

“We think this will be the case in Alzheimer’s as well because it is a complex disease with many contributing and potentially causal factors,” said Pfeifer in the interview with 

 before the semorinemab phase 2 results came out. “As such, it may be difficult for a drug with a mechanism of action focused on a single part of the disease process, such as beta-amyloid plaques, to make a meaningful impact, especially in symptomatic patients.”

“This is excellent news for everyone involved in Alzheimer’s research, and hence for AC Immune—every new piece of data we build up as an industry is important for informing the search for a successful treatment,” she continued.

Pfeifer sees another development on the horizon: Precision medicine to properly diagnose and treat neurodegenerative diseases, including Alzheimer’s disease. Her company is actively pursuing positron-emission tomography (PET) tracers against multiple relevant targets, including alpha-synuclein and TDP-43, as well as tau.

Tau may be enjoying a star turn, but Pfeifer says the concept that anti-beta amyloid therapies are most effective in the early stage of the disease, and, in particular, in preclinical AD, is still a valid one.

Her company has several active anti-beta amyloid projects, including an anti-beta amyloid antibody, called crenezumab, and an anti-beta amyloid vaccine, called ACI-24. The re-analyses and potential approval of aducanumab could potentially be highly relevant for those products and the beta amyloid approach in general, notes Pfeifer.

“We will have to wait and see how the FDA responds to Biogen’s filing,” she says.

The negative results from the phase 2 trial of semorinemab were reported after this story was published in our September print issue. This version was edited afterward to include information about that trial. 

Negative results for semorinemab have deflated some of the hopes for a tau as a target, although a winning strategy Alzheimer's may involve hitting several targets at once, including tau.

Alzheimer’s Research Shifting to Tau as a Target

COVID-19 is certainly important. But oncologists, people with cancer, and complex ecosystem of cancer care in the U.S. are grappling with other important issues as well — reimbursement, distorted incentives, the implications of the massive amount of data that is available, and, of course, high costs and prices. Below are thoughts from five experts on these challenges and how they might be met.

Oncologists hired New Century Health in Brea, California, to help them navigate the CMS Oncology Care Model and other new ways of paying for cancer care. This gave the company’s chief medical officer, Andrew Hertler, M.D., FACP, a front-row seat in the struggle to bring value-based care to organized oncology, which he views as being a long time coming.

“Today’s fee-for-service oncology business model misaligns incentives by rewarding practices for keeping margins and service volumes high — even when it’s wasteful — rather than for optimizing patient outcomes,” he says. “While discussions of drug pricing dominate the cost- control conversation, we as practitioners have been abdicating responsibility and missing the opportunity to address cancer’s financial toxicity.” The term “financial toxicity” was coined to describe the health effects that high out-of-pocket costs can have on patients if they skip treatment, as well as the financial distress itself as they go through their life savings to cover their treatment costs.

In 2018, spending on cancer drugs in the U.S. reached $57 billion, double the total from 2013. The average cost of a new cancer drug was $150,000 in 2017. Under the buy-and-bill system used in Medicare Part B, CMS pays physicians the average sales price (ASP) of a drug, plus a markup, which had been traditionally been set at 6% but is now 4.3%. It is a common critique of buy-and-bill that it creates an incentive to prescribe more expensive drugs (or, at the very least, that it removes any incentive to prescribe less expensive ones) because the markup is a percentage of that higher cost. Moreover, some physicians and hospital outpatient departments get drugs below the ASP.

Hertler says that some of the expensive oncology drugs, old and new, are true game changers that have extended lives by many years. “But oncology is also rife with examples of therapies that dramatically increase the costs to our healthcare system while bringing relatively minor improvements,” he says.

“If you’re among the two additional individuals in every 100 who benefit, it’s a winning proposition,” Hertler continues. “But on a population level, however, the costs to our healthcare system and to society can be significant if we routinely make this decision for all cancers.”

That is why, in his opinion, continuing this reimbursement model of rewarding the selection of more expensive, less efficacious drugs is not sustainable or acceptable, and if unchecked will ultimately limit patient access to care.

New Century Health and Hertler see clinical pathways as a way to deal with drug costs. “These care pathways guide oncologists in their selection of treatment regimens based on the latest clinical data and help prioritize the most effective treatments with the fewest side effects and lowest cost,” says Hertler, who also talks about the need to engage oncologists and keep them involved. “Taken together, this approach is key for allowing oncology practices to take costs into their own hands and drive savings and improvements across the patient journey,” he says.

Jeff Patton, M.D., CEO of OneOncology, believes the biggest issue facing oncology is the high cost of specialty drugs.

“It’s unsustainable for patients, physicians, employers and even health plans,” says Patton, who was named CEO of the large specialty network headquartered in Nashville, Tennessee, in May. “Even when community oncologists don’t bill for their work, the cost of therapies causes too much financial toxicity for patients and difficult decisions about coverage and value for employers and plans.” Also, says Patton, an analysis by OneOncology showed that the high cost of specialty drugs “poses challenges” for practices in value-based care arrangements, such as the CMS’ Oncology Care Model.

Patton says drugmakers could fix the problem of high prices with more rational pricing — or Congress should give CMS the power to negotiate prices.

Dane Dickson, M.D., a practicing oncologist and CEO and founder of Taproot Health in Salt Lake City says oncologists are being asked to do so much more with so much less.

“Decreasing reimbursement, increasing regulations, endless payer requirements and difficulties accessing needed drugs — not to mention the challenges of COVID-19 — are critical problems on their own,” he says. “As oncologists, our priority has always been to patients. How can we provide excellent care for today’s patients, plus participate in valuable cancer research initiatives to help the patients of tomorrow, when reimbursement is being slashed and administrative burdens are outrageous?”

Dickson believes the real-world data that clinics generate can become a powerful method of advancing cancer research and provide financial resources to clinics.

“But (these) data (have) to be organized and shared to have the greatest value,” he says. “Data (are) a commodity worth billions of dollars, yet many oncology clinics ignore this potential revenue stream and may allow it to be siphoned off by others. Oncology clinics need transparent solutions to empower them to collect and share quality data.”

Speaking of data, Dickson pointed to its ownership and patient consent as another trouble spot in oncology. Should patients be asked before their data are taken and sold for private gain? Should clinics have transparent control over the data they are generating?

“Currently, most of the real-world data being provided to third parties is being done without patient consent,” he says. “Some patients may have agreed to a vague disclaimer in any of the endless forms they have to sign before receiving care, but this is not informed consent by any stretch.”

This issue is further complicated by genetic-testing data, which could easily identify patients, especially those with rare cancers.

“The right thing to do is ask patients and clinics if we can collect, organize and transparently share data, so all parties know how their information is being used,” Dickson says.

According to Claire F. Verschraegen, M.D., director of the Division of Medical Oncology at The Ohio State University College of Medicine, even although oncology is seeing the approval of many new drugs, there’s a need to simplify clinical trials. There are a lot of new approvals for new drugs in oncology, and the complexity of the approval process is still challenging. “I feel like we’ve created a monster of administration when we run clinical trials,” she says.

For example, a randomized phase 3 trial may be conducted worldwide at hundreds of sites. Verschraegen believes fewer sites are needed. She also says researchers could pare down the amount of data they are collecting. “If the goal of the study is to measure these 10 items, why are we recording all the things that happen that may have no bearing on the study? Why don’t we just focus on the essentials?” she asks. “I think we should come up with an international reorganization of how we run clinical trials to make them more efficient.”

COVID-19 is certainly important. But oncologists, people with cancer, and complex ecosystem of cancer care in the U.S. are grappling with other important issues such as reimbursement, distorted incentives, the implications of the massive amount of data that is available, and, of course, high costs and prices. Included are thoughts from five experts on these challenges and how they might be met.

5 Changes That Should be Made in Oncology

Martin Moll, J.D., advises medical practices of all shapes and sizes in his role as founder and advisor at Breakaway Bookkeeping & Advising. When the topic of price transparency comes up, he immediately points out a fundamental problem.

“If you talk about price transparency, it actually requires transparency,” he said. “And at the end of the day, that’s the hard part for doctors, because they actually don’t know what things cost.”

Typically, doctors don’t calculate the individual costs of services, he said. Instead, they tend to add up their overall expenses and reimbursements and declare it a success if they end up in the black. Price transparency is another item on the miles-long list in healthcare for which the saying is far easier than the doing. Nearly two decades after the introduction of health savings accounts and high-deductible health plans and a full decade after the Patient Protection and Affordable Care Act (ACA), which required hospitals to publish their chargemasters, it’s more idea than actuality.

As an idea, price transparency is easy to grasp because it is so familiar to people living in an economy fueled by consumer spending. For decades, U.S. healthcare has been paid for primarily by third parties, insurers and public payers, and that makes people heedless of cost and not especially interested in shopping for less expensive care. But, the theory goes, if Americans knew the price of healthcare services 

 had to pay a substantial share of the cost, they would be more inclined to shop around, and expensive American healthcare would benefit from a healthy dose of market competition.

But pulling the curtain back on prices isn’t so easy. Despite efforts from presidents on both sides of the political aisle, healthcare prices remain obscure, confusing or both.

In November 2019, President Donald Trump signed an executive order that translated into two new price-transparency rules, one governing hospitals and the other, health plans. Both are scheduled to take effect next year. The hospital rule would require hospitals to make public their rates under negotiated agreements with insurers, as well as how much they are willing to accept in cash payments from patients for particular services. For 300 common “shoppable services,” hospitals would need to make such data available in a consumer-friendly format rather than merely a machine-readable file.

For insurers, the “transparency in coverage” rule would require them to provide cost-sharing information to members, including estimates for covered items and procedures. They would also need to publicly disclose negotiated rates for in-network providers and allowed amounts for out-of-network providers. According to CMS Administrator Seema Verma, the rules would give consumers the information they need to make practical and informed healthcare decisions — and more. “Today’s rules usher in a new era that upends the status quo to empower patients and put them first,” she said in a press release.

But the hospital rule quicky became ensnared in court challenges by the American Hospital Association. In June, a federal district judge ruled in favor of the administration and against the hospital association, referencing the argument that patients who know about prices will put pressure on providers to lower costs. The hospital association said it will appeal the decision. The insurance rule had yet to be finalized as of this summer; once it has been, there is little doubt that it too will face legal challenges.

Katie Keith, J.D., M.P.H., a healthcare consultant who blogs about the ACA for 

, said these rules are deeply unpopular among insurers and hospitals. “I don’t think anyone in the industry wants their prices — their negotiated rates — to be public,” she says. Brian Blase, Ph.D., a former Trump health administration official who was influential in developing price transparency polices, said in a recent 

 blog that hospitals aim to maximize profits and they oppose price transparency because they believe it will reduce those profits.

Other Trump administration attempts at price transparency have also become bogged down. A 2019 executive order that would have required drug companies to disclose the wholesale acquisition costs of drugs in advertisements was blocked after a court ruling that the Department of Health & Human Services did not have the authority to compel such disclosures. In response, the president began calling on Congress for a bipartisan drug price transparency bill. A number of members have been working on such bills, but so far no major proposal has made it to the president’s desk.

Although the administration has moved to trim regulations in a number of different industries, Keith said healthcare is one area in which Trump has pushed to add new consumer-friendly regulations, even when that has meant going to war with industry. “They have really doubled down on interoperability too,” she says. “It’s not quite the same thing as transparency, but it’s kind of that same concept that they want patients to have access to (information).”

Eric Ellsworth, M.S., MBA, director of health data strategy at Consumers’ Checkbook says many of the current forms of healthcare price transparency are not meaningful to consumers. For instance, although some insurance sites give estimates of costs, he says, “you still can’t really take that to the bank. You can’t do anything with that. It’s just sort of an awareness tool.”

In response to the proposed insurance rule, American’s Health Insurance Plans (AHIP), the main trade group for the health insurance industry, submitted a 57-page comment in which they assert that transparency could end up harming consumers. “It will undermine competitive negotiations and push healthcare prices higher — not lower — for patients, consumers and taxpayers,” wrote Matthew Eyles, M.S., AHIP president and CEO. The group argues that if a hospital suddenly found out it was receiving less than a competing hospital for the same procedure, it would demand a higher price. AHIP also criticizes the scope of the transparency, arguing that the rule should focus only on “shoppable” services.

Moll notes that although hospitals are better than smaller medical practices at putting price tags on services, those prices don’t necessarily translate into the cost of the service alone. Hospitals can have drastically different prices on similar services, in part, because they have unreimbursed costs, such as indigent care, that they must account for through billing for reimbursed procedures. The cost of the unit care is almost irrelevant, he says, because hospitals are focused on their overall hospital margin. Moll says there’s currently a gap between reimbursement and value. He described a scenario in which an orthopedic surgeon has significantly lower readmission rates. That surgeon may save the payer money but usually has had little luck convincing insurers to recognize such that with a higher reimbursement rates.

Ellsworth believes the fundamentals of the healthcare marketplace will need to be adjusted before price transparency works the kind of consumer empowerment magic that its proponents envision. He sees the episode-based payment models as a step in the right direction because they give providers an incentive to control costs. Such payment models would also help consumers to see their care for a particular medical problem as a unit, he notes. By choosing between packages of transparently priced treatment options, consumers could make informed decisions about what they are truly want to pay for , says Ellsworth. “People have to get a little more used to defining their own goals,” he says.

Keith says asking consumers to make decisions based on cost effectiveness might be a bridge too far. However, she believes that having price data publicly available could help improve the healthcare system in other ways by, for example, aiding cost-effectiveness research.“I don’t buy that it’s effective at the individual consumer level,” she said. “But for the system, I think it could be really valuable.”

Jared Kaltwasser is a healthcare reporter based in Iowa.

The Trump administration’s attempts at pulling back the curtain have ended up in court.

For Price Transparency, the Outlook is Murky

Is it fair to say that leadership in today’s healthcare environment is more challenging than ever?

The COVID-19 pandemic has tested every healthcare executive’s ability to adjust — and adjust again. From mid-March through summer and now early fall, the ups and downs of the outbreak have occurred at a furious, unpredictable cadence. The only certainty has been more uncertainty.

The following experts cited both new skills and new reasons to pursue older proficiencies. Although they made their statements before the oubreak of COVID-19, the insights they shared became more relevant than ever.

“Leaders are constantly observed and modeled,” says Darnell Dent, CEO of Dent Advisory Services and member of the 

® editorial advisory board. Closed-minded, top-down leaders cannot hide, especially now. They are judged by what they say and don’t say and what they do and don’t do. And when a leader is not visible, misinformation will spread.

As a result, healthcare executives need to be transparent in a way that is more real than ever. For important decisions, they should involve more, not fewer stakeholders. True collaboration makes for greater alignment, better decisions and better execution. “Executives don’t have to give up their power to make the ultimate decision,” says Dent, but they need to keep in mind that leadership is a team, not an individual, sport.

Sometimes transparency means saying, and doing, things that make people unhappy or uncomfortable. Executives need to be careful about overcommitting and overpromising. They have to be willing to say no to requests they cannot fulfill, and then be clear about the reasons why.

“Whenever there are three or more emails in a chain, it’s time to talk,” advises Virginia Calega, M.D., vice president of medical affairs for facilitated health networks at Independence Blue Cross in Philadelphia, who is also a member of the 

® editorial advisory board. “The richness of conversation helps avoid misunderstandings,” she says. In today’s social media–fueled world, it’s easy to mistake the quantity of our communication for quality. Of course, COVID-19 has put a premium on video conferencing and real-time talk, be it through Microsoft Teams or Skype — or the old-fashioned cell phone.

Does this mean that C-suite executives need to talk to everyone who has a problem or raises an issue? Of course not. “Middle management is still necessary to prioritize and direct the flow of information up and down the chain of command,” says Don Hall, M.P.H., principal of DeltaSigma LLC and member of this publication’s editorial advisory board.

“You’ve got to be informed on what’s happening in your market,” adds Hall. Critical information — emphasis on critical — must be allowed to flow quickly from the front line of an organization to the top. Hall likens the ideal flow of information within an organization to the body’s nervous system. “You may not actively think about your toes, but when you hit them against something, your body sends a distinct message!”

“Healthcare executives need to consider the ‘what-ifs’ seriously,” says Sherry Rohlfing, who is a principal at DeltaSigma with Hall. Whether it’s the latest twist and turn of COVID-19, an unexpected competitor, or a disruptive technology, change doesn’t call ahead and make an appointment. It’s there, at your door.

But you don’t need to be caught flat footed. “Leaders need to look within their organizations to find and appoint others to research and prepare for these changes, should they occur,” says Rohlfing.

Leaders should strive to make the right decisions (of course) but also be prepared to be wrong. “You need to save yourself from being the emperor who has no clothes,” says Dent. “People in your organization must feel free to tell you both bad (and good) news.” With some notable exceptions in some very high places, gone are the days of being the last to acknowledge a wrong decision.

“You need to learn to appreciate people who do not think like you,” says Donald Pirc, vice president of managed care at Promedica Health System in Toledo, Ohio. Building teams of like-minded people results in weak teams, without different points of views, expertise and experience. Attempting to clone one member, regardless of performance, results in a weak team. Leaders of all levels can play to their strengths when they are not imitating others. And often, varying skills and ideas are required to maximize a team’s results.

Dent recalls his transition from Marine Corps officer to corporate America. “One of the first things my mentor told me is that, here in the corporate world, you can no longer simply issue orders and expect them to be followed.” Collaboration, vertically and horizontally, and between organizations, is essential.

When leaders democratize the flow of ideas, they can receive them fresh, from unexpected places. “Not only can frontline employees warn you of what’s coming, but they’re sometimes the best source for understanding what’s happening right now,” says Hall.

“Many well-meaning leaders of insurance companies are physicians who received limited training in behavioral health,” says Sam D. Toney, M.D., a psychiatrist and healthcare consultant in Tampa, Florida.Part of the problem is discordant measurement. “One measures a patient’s LDL with blood work. The severity of major depression is measured using patient feedback,” says Toney.

So, how can providers and payers work to offer behavioral services in a cost-effective way? “With the extensive data sets we have today, we can correlate the risk between physical and behavioral conditions,” comments Toney. “We can see, for example, how a patient’s level of depression affects their adherence to diabetes care.”

“I believe that everyone has the best intentions, which is to help people get and stay healthy,” says Calega. “However, ours is a complex business, especially when it comes to ensuring people get the right care at the right time in the right setting.”

Cost containment may seem to run counter to delivering the best care; it often looks that way to outsiders. But many times, just the opposite is true. “Higher-cost care tends to result in lower-quality outcomes,” says Hall. More visits and tests and can be a sign of a treatment path gone awry.

Data and their analysis can help strike a balance between cost control and good outcomes. “The data we collect through our value-based contracts and share with our providers help us to explore problem areas and collaboratively design programs to address potential solutions,” says Calega.

“Many healthcare executives grow comfortable with their current system of compensation,”says Dent. In some cases, they have figured out how to maximize their current system for personal gain. Plus, as Dent notes, “every organization has a certain level of inertia.”

Instead of fighting value-based payment, Dent adds, healthcare executives need to pause and ask themselves, “How do I get that done?” The answer to this question again requires transparency and collaboration.

Chris Pawar is a medical writer based in Cleveland, Ohio.

The COVID-19 pandemic has tested every healthcare executive’s ability to adjust — and adjust again. From mid-March through summer and now early fall, the ups and downs of the outbreak have occurred at a furious, unpredictable cadence. 

7 Skills Healthcare Executives Need to Succeed

With COVID-19 still leaving many Americans wary of going to the doctor’s office for in-person care, large drugstore chains and retailers are seeing an opportunity for new patients for their in-store health clinics. The clinics are “a one-stop shop” where patients can see a healthcare provider, get help managing chronic conditions, pick up medications and have laboratory tests done, says Kulleni Gebreyes, a principal and physician leader at Deloitte. She says retail clinics haven’t seen a drop in patient volumes since the outbreak began in mid-March. Physician groups, including the American Academy of Family Physicians and the American College of Physicians, have put out policy statements expressing reservations about the clinics possibly undercutting primary care, but retail clinics are now an established part of American healthcare delivery.

The competition is heating up among the retailers. Walgreens Boots Alliance announced in July that it was planning to open 500 to 700 offices inside its stores over the next five years in partnership with VillageMD. Walmart opened two additional Walmart Health clinics in June, giving it four in the South. These Walmart clinics offer dental, vision and behavioral care, fitness programs and assistance with health insurance issues, as well as medical services. And, clearly, Walmart is bringing its low-prices game to healthcare: A price list on Walmart’s website shows a price of $40 for an office visit, $25 for a dental exam with X-rays and $60 for a therapy session for new patients. “Walmart is committed to making healthcare more affordable and accessible for customers in the communities we serve,” Marilee McInnis, a company spokesperson, said in an email.

One of the virtues of the retail clinics is the price transparency, a sharp contrast to the blanket of obscurity that cloaks price in most parts of the U.S. healthcare system (see page 28). Retail clinics allow patients to “clearly see upfront” the cost of care, Gebreyes says, and the retail clinic cost is often two to three times lower than more typical providers. That cost difference may loom large now with millions of Americans being laid off and losing employer-based healthcare insurance, which tends to be more generous in Medicaid or ACA exchange plan coverage.

Walgreens’ deal with VillageMD put the drugstore chain in more direct competition with CVS Health, which pioneered the retail clinic with its MinuteClinics and now has ambitious plans for its HealthHUBs, designed to provide services to manage chronic conditions. CVS says it has plans to have 1,500 HealthHUBs operating by the end of 2021. In its first-quarter earnings call, the company said it had almost 100 locations in 17 states up and running in April, but the conversion of more stores had been put on hold because of COVID-19.

Walgreens and VillageMD say they expect to have clinics in more than 30 markets, with more than half located in underserved areas as designated by the Department of Health & Human Services. After a first phase of five years, hundreds of facilities will be added, the companies say. The offices will be located inside existing Walgreens locations, with most taking up about 3,300 square feet, an area approximately three-quarters of the size of a basketball court. Some will be as large as 9,000 square feet. During the first five years, VillageMD is expected to recruit more than 3,600 primary care providers. Walgreens pharmacists will be part of a patient’s care team.

The two companies tested the in-store primary care offices at five Houston-area Walgreens starting in November. “This rollout is a major advancement of one of Walgreens Boots Alliance’s four key strategic priorities, creating neighborhood health destinations,” Stefano Pessina, executive vice chairman and CEO of Walgreens Boots Alliance, said in the press release. As part of the deal, Walgreens is investing $1 billion in VillageMD over three years, and when the deal is complete, the pharmacy giant will hold a 30% stake in the company.

Last year, Walgreens seemed to be in partial retreat from the in-store healthcare clinic market. In October, the company announced it was shuttering the 150 clinics that it operated on its own. But partnership seems to be the company’s strategy. Walgreens has 230 clinics that are run in conjunction with local health systems that provide acute medical care, a spokesperson said in an email. The company also has 14 primary care locations, including five senior-focused clinics operated with Humana. Four are in the Kansas City area and one is in South Carolina, and the companies are evaluating new locations for expansion.

Walmart hasn’t said how many more of its Walmart Health centers are in the works, but McInnis said expansion is planned.

Although many of the current generation of retail clinics only provide urgent care for minor acute issues such as strep throat or an ear infection, or routine care such as vaccinations, others have higher ambitions and can play an important role in helping patients manage chronic conditions, Gebreyes says.

If someone has diabetes, for example, they can come to a retail clinic and get the medication and supplies they need, along with foods to help them eat healthily, she explains. Some have a greeter at the door who helps patients navigate the clinic and the services available, says Gebreyes. “(They) respond very positively to it.” The convenience factor also works in favor of the retail clinics. According to CVS Health, the company has more than 9,900 retail locations and more than 1,000 MinuteClinics. Walgreens says it has more than 9,000 drugstores.

James Beem, managing director of global healthcare intelligence at J.D. Power, says patients appreciate the opportunity retail clinics give them to consult with healthcare providers. Patients say that often at doctor’s offices they are “rushed in and out without enough time to converse.” (Some might notice the irony of MinuteClinics giving patients more time.)

Whereas telehealth has taken off during the pandemic, many patients are hesitant to get in-person care, but “(they) still want to be able to have face-to-face consultations and be examined without a digital interface,” says Beem. Now that CVS owns Aetna, the insurer may steer patients with chronic conditions to HealthHUBs, making CVS Health “100% responsible for patient care and outcomes,” notes Beem.

One possible drawback to receiving care at a retail clinic is the lack of integration of your medical information into your core medical record, Gebreyes says. And there is concern that because of their accessibility and affordability, retail clinics could drive up unnecessary utilization of services, she says.

The next frontier in retail clinics could be behavioral healthcare, such as that offered by Walmart, Gebreyes says. An ongoing shortage of mental healthcare providers, combined with the stress many people are feeling because of the pandemic and the rocky economy, are overtaxing behavioral health services. And even if patients can get appointments with a mental healthcare provider, they may be reluctant to visit one in person. “People don’t have great access to behavioral healthcare,” Gebreyes says. “Retail clinics can be a great place for stigma-free care.”

Susan Ladika is an independent journalist in Tampa, Florida, who writes about healthcare and business.

CVS Health, Walgreens and Walmart are pushing ahead with ambitious plans for in-store clinics and doctor’s offices.

Healthcare goes retail 

COVID-19 has seemingly reached into every corner of American healthcare, with new procedures, regulations and safety precautions required to keep patients and caregivers safe and protected from the virus.

Wearing masks and social distancing are crucial, but these low-tech strategies are hardly new; versions were used during the 1918 flu pandemic.

Videoconferencing has become part of everyday life, and telehealth, which was stuck in the doldrums for years, has taken flight.

Biotechnology firms are turning to old and new technologies to conduct research, ramp up testing, and develop and test vaccine candidates. Behind the scenes, recruitment platforms have been deployed to fill positions with trained healthcare professional, and robots are assisting in medical development and deliveries to cut down on human contact.

Here is a list of 10 technologies that have been part of the response to the COVID-19 pandemic:

Healthcare tech has supported communitywide contact tracing and digital COVID-19 risk assessments. Adam Sabloff, founder and CEO of VirtualHealth, a New York City healthcare software and care management company, led a team that developed a screener survey to help identify patients who may have contracted COVID-19 or are at risk of infection.

The Transformation of Value-Based Care, its Future After COVID and the Election

“The pandemic has increased the need for our healthcare system to adopt a more proactive care model, an approach that is all about anticipating patients’ needs before an emergency (and costly) healthcare event,” Sabloff says.

Russ Thomas, CEO of Availity, a healthcare information network company headquartered in Jacksonville, Florida, says technology has been indispensable during the pandemic, accelerating automation of clunky, manual processes.

Providers and payers have long used electronic transactions to process claims and other data, but several processes still rely heavily on phone calls, paper or fax machines, according to Thomas. “When COVID-19 forced staff to work remotely, both providers and payers had to quickly adopt other means of communication. Fortunately, technology already existed for sending secure electronic attachments and automating prior authorization.”

A silver lining of the pandemic is that it forced the sector to accelerate use of these tools, according to Thomas. Technology enabled the consolidation of policies and procedures into a central location for ease of use by providers, he says. Moreover, with so many people working remotely, these same technologies helped providers send relevant documentation and information to payers electronically.

Robert L. Quigley, M.D., senior vice president and regional medical director of International SOS, a risk mitigation firm, notes that one of the strongest technological tools in the fight against COVID-19 is artificial intelligence (AI) and the capability to analyze enormous amounts of data. “AI can be used to evaluate a large number of patients’ medical records at once to identify which (patients) are (at) highest risk and should receive treatment first,” he says.

Remote surveillance of patients on ventilators

Some hospitals are using remote surveillance to effectively monitor COVID-19 patients on ventilators and protect care teams. Chris Gutmann, executive director of information technology (IT) for Yale New Haven Health, describes how this large healthcare system in Connecticut remotely monitors patients on ventilators at its five hospitals.

“The VPS (ventilated patient surveillance) workstation helps staff remotely see and hear the ventilators in the nontraditional ICU settings of the pandemic,” he says. The workstation analyzes livestreaming data from ventilators and makes it available to the health system’s tele-ICU group. “It escalates emergent clinically actionable events to respiratory therapists, pulmonologists and intensivists,” Gutmann says. Remote surveillance helps protect front-line workers from unnecessary exposure to infection and reduces the use of personal protective equipment (PPE).

Access to clinical histories at the point of care

Matthew Michela, president and CEO of Life Image, a healthcare interoperability company in suburban Boston that specializes in the sharing of images, says many healthcare institutions are using technology to reduce dependence on physically managing records, help control infection spread and increase access to important clinical data.

He cites a recent study that revealed that just 6% of patients had their health history available when they went to the hospital for COVID-19 treatment.

“Healthcare data is notoriously siloed,” Michela says, voicing a common sentiment. But delivering acute care during a pandemic puts a premium on access to a patient’s clinical history at the point of care, he notes, and the healthcare system responded to the need. “The gap in access to important clinical information was quickly recognized, and many in the industry deployed existing technology solutions to effectively exchange data with community providers or patients to better coordinate care,” he says.

New technology for rapid testing at the point of care will reduce backlogs and allow hospitals and practices to replace temperature scans with actual virus tests, says Ron Chiarello, CEO, founder and member of Alveo Technologies, a biotech company in Alameda, California, that is developing at-home tests of infectious disease, including COVID-19.

“This new technology will allow healthcare organizations to see patients basically as normal again for all the delayed, nonemergent care; get newly identified COVID cases into care faster; and save the extra PPE for treating the cases that really need it,” he says. New testing technology will also help with accurate data collection about the number of cases, says Chiarello.Researchers at Yale have reported success with a saliva-based test that they argue would eliminate the costs and the logistical bottlenecks of tests that depend on nasopharyngeal swabs. The NIH announced in late July that it was investing almost $250 million in new COVID-19 testing technologies. Using a “Shark Tank”-like approach, NIH has awarded contacts to three companies developing point-of-care tests: Mesa Biotech and Quidel, both in San Diego, and Talis Biomedical in Menlo Park, California. NIH is also investing in four companies developing lab-based tests: Ginkgo Bioworks in Boston; Helix OpCo in San Mateo, California; and Fluidigm and Mammoth Biosciences, both in South San Francisco, California. Researchers at Yale have reported success with a saliva-based test that they argue would eliminate the costs and the logistical bottlenecks of tests that depend on nasopharyngeal swabs.

Some hospitals were using ultraviolet C (UVC) light to sterilize rooms before the COVID-19 pandemic. At Anne Arundel Medical Center in Annapolis, Maryland, a robotlike device dubbed CRIS (clean rooms improved safety) emits UVC to disinfect rooms in the emergency department and intensive care unit. UVC’s antiviral and antibacterial properties are well documented, and recently published research suggests that UVC will inactivate SARS-CoV-2. The FDA has, though, expressed some reservations: “Currently there is limited published data about wavelength, dose and duration of UVC radiation required to inactivate the SARS-CoV-2 virus,” the agency says on its website. But most agency’s comments are directed at at-home UVC devices.

Justin Williams, CEO and founder of Noteworth, a digital healthcare company, says that remote technology allows monitoring of patients who are symptomatic but don’t need hospital care. “This technology not only provides key telemetry about a patient but (also) can do it asymmetrically, freeing up staff resources desperately needed in dealing with very sick patients,” he says.

Remote monitoring, which is part of his company’s platform, can also help gather data over a geographic area, giving a real-time view of disease, says Williams.

Brian Miller, CEO of Dewitt Hospital and Nursing Home in eastern Arkansas and a board member of the Arkansas Rural Health Partnership, notes that interoperable health IT makes a big difference when dealing with COVID-19, particularly in terms of data sharing.

“At the peak of the current health crisis, we finalized implementation of a cloud-based, HIPAA-compliant EHR (electronic health record) system provided by Azalea Health, which enabled us to connect our clinic and hospital to the state health information exchange to collect and securely store health data from thousands of constituents being tested at the clinic,” he says. Because of efficiency gains, physicans have been able to focus on conducting more tests, he says.

Although it falls last on this list, developing an effective vaccine would be the most important technological feat of all. HHS launched Operation Warp Speed, a partnership between government and industry. Vaccine development got off to an early start, partly because of how quickly the SARS-CoV-2 genome was sequenced. The federal government is funding late-phase trials of vaccines developed by Moderna, the partnership of Oxford University researchers and AstraZeneca, and the partnership of the German company BioNTech and Pfizer. Other companies that received funds to support vaccine development include Johnson & Johnson, Novavax, and Sanofi and GlaxoSmithKline.

A look at how technology is making a difference in the delivery of care during the pandemic.

10 ways healthcare tech is helping combat COVID-19

Transitioning to value-based care requires that healthcare system participants rethink how to deliver and compensate for healthcare. Under the current system, healthcare is delivered and paid for as incremental units of care by individual practitioners — the individual doctor’s visit, for example, or a procedure. In contrast, a value-based care system recasts the “unit” of focus as the individual patient and includes all the care that patient requires (i.e., not simply the care one provider delivers). This means that a provider must be thoughtful and clear, not only about the care they themselves deliver, but about all the up- and downstream care that others are giving to that patient. It means understanding how care affects a patient’s experience and outcome, across the full continuum of care, inside and outside of one’s particular office.

This holistic approach to care leads to the natural inclusion of a variety of providers, extending from the traditional (such as physicians, nurses and therapists) to the nontraditional (such as doulas, nutritionists and mindfulness instructors, among others). Value-based care is team-based care, and all providers must work collectively to ensure the holistic care of the patient.

But most commercial insurance companies design benefit plans within the confines of the prevailing fee-for-service methodology. Within this system, providers are reimbursed for each procedure, test and treatment, regardless of patient outcome. A low-cost or nontraditional option will generally not be considered, even if the patient would benefit, because it’s not a covered benefit and so will not be paid by the health plan. Value-based care models, on the other hand, create an opportunity to really reconsider what has the biggest impact on a patient’s outcomes, and not only what is or is not a covered benefit.

This leads to important considerations of compensation. Under value-based care, payment is based on patient outcomes and the efficient use of resources, not on any particular increment of care. Therefore, each stakeholder must understand all the care that is required and make good choices about who to work with across the continuum of care.

Consider paying for a car service. A commercial health plan paying a fee for service probably would not cover the cost of a car service to take a member to a healthcare appointment. The car service is not “care” in the traditional sense, but getting people to the doctor’s office can have a major influence on their outcomes.Under value-based care, outcomes becomes paramount. There is also new emphasis put on evidence about quality and cost-effectiveness because both quality and cost of care factor into what providers are paid. Many nontraditional practices, unlike traditional medical procedures, are low cost and high impact.

The need for collaboration and team-oriented decision-making extends beyond the continuum of providers. Payers bring valuable experience and data to the table; health plans maintain longitudinal claims data. But most health plans are large, bureaucratic-to-their-bones organizations, so the transition to value-based care payment is often slow and halting. Clinicians who approach payers with lofty ideals, but no understanding of their limitations, are likely to wind up frustrated. Likewise, technology vendors wooing payers with dazzling innovations for the care and payment system will probably be turned away if they are unable to show support of providers (preferably in the payer’s market).

Editorial piece by Managed Healthcare Executive's Editorial Advisory Board Member, Lili Brillstein. Brillstein is a nationally recognized expert on value-based care and the CEO of BCollaborative, a healthcare consulting company.

MHE September 2020