One Medical lays out potential risks ahead of IPO

The primary care startup filed for an initial public offering shortly after the New Year.

One Medical, a primary care clinic startup based in San Francisco, kicked off 2020 by filing for an initial public offering (IPO) and detailing its forward-looking opportunities and risks.

The company is a direct primary care provider that currently services around 400,000 members across nine markets, with plans to expand to three additional markets this year, according to its filing.

The company also reported $212.6 million in net revenue at the end of 2019, though losses from operations totaled $45 million. In October, CNBC reported that One Medical was valued at $1.5 billion during its latest financing round last year.

One Medical is backed by major investors, including the Carlyle Group and Alphabet. Google, which is a subsidiary to Alphabet, is an enterprise client that accounted for 10% of One Medical’s total revenue in 2018.

The company is the latest Silicon Valley–based company planning to go public with a specific aim to make a play in the healthcare industry. Last year, Uber, Lyft, and Slack all debuted on Wall Street with plans to disrupt healthcare.

In S-1 filings, companies must provide a comprehensive overview of business operations, including any potential risk factors to the enterprise as it prepares to be publicly traded.

One of the most immediate risks facing One Medical is the need to recruit and retain quality primary care providers.

While One Medical expects to have expanded opportunities as a public entity with a growth strategy, the company predicts increased competition for a key component of its business model.

The company stated that it expects insurers and private equity firms to acquire providers or employ physicians in markets where One Medical operates.

The emphasis by One Medical on acquiring quality care providers is likely to draw the attention of hospital and health system executives as both directly compete for the same talent pool.

The company acknowledged the need to effectively recruit and retain physicians but also noted that maintaining these relationships might be negatively impacted by outside factors. These include changes to federal reimbursement rates among other “pressures on healthcare providers.”

Below are some additional risks laid out in One Medical’s S-1 as the company moves forward with its plan to go public.

REVENUE AT RISK IF VOLUME OF MEMBERS WITH PRIVATE HEALTH COVERAGE, SPECIFICALLY EMPLOYER-SPONSORED PLANS, DECLINES

As fewer employers opt to self-insure and proposed healthcare reforms aim to drastically change or outright eliminate employer-sponsored health coverage, One Medical faces financial challenges.

“The resulting loss in members may also decrease the fees we receive under our contracts with health network partners as fewer members engage in their healthcare networks,” the company said. “Were this to occur, there is no guarantee that we would be able to compensate for the loss in revenue derived from enterprise clients and health network partners by increasing retail member acquisition.”

GROWTH OPPORTUNITIES “SUBSTANTIALLY DEPENDENT” ON STRATEGIC PARTNERSHIPS WITH THIRD-PARTY PARTNERS

The company noted that it is crucial to meet third-party partner expectations since One Medical continues to “substantially depend” on its external clients.

The business model relies on satisfying partner expectations, the company said, and avoiding situations that might result in contracts being amended or terminated.

During the first nine months of 2019, almost 30% of One Medical’s net revenue came from partnership revenue. Most of those proceeds were the result of contracts with health network partners, the company said, including HMOs.

“If we are unable to successfully continue our strategic relationships with our health network partners, on terms favorable to us or at all, or if we do not successfully contract with health network partners in new jurisdictions, our business and results of operations could be harmed,” the company said.

Beyond the material impact partners have on the bottom line, One Medical stated in its S-1 filing that third-party vendors host and maintain the company’s technology platform.

MUST ABIDE BY HIPAA REGULATIONS AND USE PATIENT HEALTH INFORMATION (PHI) CAREFULLY

Much like other Silicon Valley companies going public with healthcare ambitions, abiding by regulations to protect PHI is key for One Medical’s success.

The company noted that compliance with state and federal health privacy laws, most notably HIPAA, could cause One Medical to incur “substantial costs.”

Failing to abide by HIPAA regulations or suffering from a data breach would negatively impact the organization’s bottom line, the S-1 read. However, One Medical also anticipates additional PHI laws enacted at the state and municipal level going forward, specifically referencing the California Consumer Privacy Act of 2018.

“The potential effects of this legislation are far-reaching and may require us to modify our data processing practices and policies and to incur substantial costs and expenses in an effort to comply.”

https://www.healthleadersmedia.com/finance/one-medical-lays-out-potential-risks-ahead-ipo

Hospitals may be penalized by CMS for serving disadvantaged patients

Provider organizations servicing vulnerable communities could be judged on “social factors outside of their control,” according to the study.

Hospitals that serve disadvantaged patients in vulnerable communities may be unfairly penalized by the Centers for Medicare and Medicaid Services (CMS) rating system, according to an analysis released by the University of Chicago Medicine Wednesday morning.

The study found that the CMS rating system does not account for social risk factors (SRF) and as a result, provider organizations could be judged on “social factors outside of their control.”

Researchers found that in an analysis of more than 3,600 hospitals across the country, those that provide care in neighborhoods with higher social risks achieved lower quality scores from CMS.

Hospitals are likely to be judged, and potentially penalized, based on geographic location, Elizabeth Tung, MD, MS, lead author of the study, said.

“Living in a disadvantaged community can influence health directly through social factors like substandard housing conditions, inadequate access to food or transportation, and high levels of stress due to safety concerns,” Tung said in a statement. “These factors work against well-being, so patients from these neighborhoods have more barriers to health to begin with.”

The study found that hospitals in disadvantaged neighborhoods lagged in scores for timeliness of care, largely a measure of emergency room wait times, and hospital readmissions.

However, researchers said that safety, efficiency, and effectiveness of care were “minimally affected” by SRFs.

Hospitals have criticized CMS’ Overall Hospital Quality Star Ratings since the system was put into place in 2016, often calling for major changes or elimination of the program.

Last February, the rating system was updated for the first time since 2017 and in August, CMS announced plans to “update” Star Ratings in 2021.

https://www.healthleadersmedia.com/strategy/hospitals-might-get-penalized-cms-serving-disadvantaged-patients

Improved Outcomes With Transcarotid Stenting vs Femoral Stenting

Target Audience and Goal Statement: Vascular surgeons, neuroradiologists, neurologists, neuropsychologists, cardiologists, hospitalists

The goal of this study was to compare outcomes associated with transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TF-CAS) among patients with carotid artery stenosis.

Question Addressed:

• Was the TCAR procedure associated with a lower risk of stroke and death compared with TF-CAS among patients undergoing treatment for carotid artery stenosis?

Study Synopsis and Perspective:

Every 40 seconds someone in the U.S. has a stroke. Strokes are commonly caused by atherosclerotic lesions of the carotid artery bifurcation. Two prospective randomized trials — the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the Asymptomatic Carotid Atherosclerosis Study (ACAS) — established carotid endarterectomy as the gold-standard treatment for high-grade symptomatic and asymptomatic carotid artery stenosis, respectively.

Action Points

• Transcarotid artery revascularization (TCAR) was significantly associated with a lower risk of stroke and death compared with transfemoral carotid artery stenting among patients who underwent treatment for carotid artery stenosis.
• Note that researchers did not see statistically significant differences between the two procedures for in-hospital myocardial infarction events.

TF-CAS has been used as an alternative method for patients at high surgical risk with carotid endarterectomy; however, evidence from the literature has shown that TF-CAS is associated with a higher periprocedural stroke risk versus carotid endarterectomy, especially in symptomatic and elderly patients.

Recently, a transcarotid neuroprotection system has been indicated in the U.S. in conjunction with a transcarotid stent system for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet prespecified criteria. The neuroprotection system enables the surgeon to directly access the common carotid artery in the neck and initiate high-rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the stent.

The TCAR Surveillance Project was designed to obtain more data about real-world outcomes of TCAR in comparison with carotid endarterectomy as performed by centers participating in the Vascular Quality Initiative (VQI).

In an updated exploratory analysis in JAMA, Marc Schermerhorn, MD, of Beth Israel Deaconess Medical Center in Boston, and colleagues looked at patients who underwent TCAR or TF-CAS from September 2016 (at the launch of the TCAR Surveillance Project) to April 2019.

Schermerhorn’s group compared 5,251 patients who received TCAR versus 6,640 patients who received TF-CAS; propensity score matching yielded 3,286 matched pairs for comparison (TCAR: mean age 71.7 years, 35.7% women; TF-CAS: mean age 71.6 years, 35.1% women).

TCAR was associated with significantly lower rates of in-hospital stroke and death compared with TF-CAS (1.6% vs 3.1%, relative risk [RR] 0.51, 95% CI 0.37-0.72, P<0.001), as well as the individual rates of stroke (1.3% vs 2.4%, RR 0.54, 95% CI 0.38-0.79, P=0.001) and death (0.4% vs 1.0%, RR 0.44, 95% CI 0.23-0.82, P=0.008). However, researchers did not see statistically significant differences between the two procedures for in-hospital myocardial infarction events (0.2% vs 0.3%, RR 0.70, 95% CI 0.27-1.84, P=0.47).

TF-CAS also led to more radiation (median fluoroscopy time 5 minutes vs 16 minutes, P<0.001) and more contrast used (median 30 mL vs 80 mL, P<0.001). Patients who underwent TCAR were also significantly less likely to fail CMS-recommended discharge criteria (16.4% vs 22.7% for TF-CAS, P<0.001), including length of stay greater than 2 days (13.9% vs 19.0%, P<0.001) and failed discharge home (7.3% vs 12.7%, P<0.001).

Ipsilateral stroke or death at 1 year were lower in patients who underwent TCAR versus TF-CAS (5.1% vs 9.6%, hazard ratio 0.52, 95% CI, 0.41-0.66, P<0.001), based on a separate risk-adjusted analysis looking at patients with 1-year follow-up.

Although there were no statistically significant differences in overall access site bleeding complications, TCAR was associated with higher risks of access site bleeding resulting in interventional treatment (1.3% vs 0.8%, RR 1.63, 95% CI 1.02-2.61, P=0.04).

No causal inferences were possible due to the observational study design. While 95.4% of all transcarotid procedures utilizing flow reversal performed in the U.S. were recorded in this registry, researchers stated that there was the possibility that stroke ascertainment or subject selection could be prone to bias.

In addition, transient ischemic attack was defined in the study as being based on focal neurological symptoms lasting less than 24 hours, rather than the current definition set forth by the American Heart Association and American Stroke Association. Also, 1-year follow-up had not been completed for all patients at the time of publication, but this was accounted for with Kaplan-Meier censoring. Additionally, the study may have been underpowered to detect differences for stroke rates between symptomatic and asymptomatic patients. Unmeasured confounding was also a possibility, the researchers acknowledged.

Source Reference: JAMA 2019; DOI: 10.1001/jama.2019.18441

Study Highlights and Explanation of Findings:

TCAR versus TF-CAS was significantly associated with a lower risk of stroke and death among patients who underwent treatment for carotid artery stenosis.

TCAR was developed to avoid the high-risk maneuvers associated with TF-CAS, especially “manipulation of the aortic arch to cannulate the common carotid artery and crossing the carotid lesion unprotected to deploy the embolic protection filter distally,” the researchers wrote. Following deployment, there was always the possibility that filter devices could allow passage of small emboli through or around the filter if incompletely placed in proximity to the vessel wall. The TCAR procedure bypasses the aortic arch and employs direct common carotid access and flow reversal prior to crossing the lesion. In one study, more than two-thirds (68%) of patients were anatomically eligible for the transcarotid approach, and 79% were eligible for the transfemoral approach.

The multicenter, single-group ROADSTER trial was the first study to confirm the theoretical benefits of TCAR by showing a 30-day stroke rate of 1.4% and a stroke-free survival rate of 95% at 1 year. Compared with the ROADSTER trial, the present study found a similar, but slightly lower, perioperative stroke rate of 1.2% following TCAR.

Notably, researchers did not see statistically significant differences between the two procedures for in-hospital myocardial infarction events.

“Transcarotid artery revascularization, which also uses a less invasive approach than endarterectomy, showed no significant difference in [the] perioperative myocardial infarction profile as compared with transfemoral carotid artery stenting in both asymptomatic and symptomatic patients,” they wrote.

“These benefits were found despite the higher rates of bleeding complications associated with intervention following transcarotid artery revascularization,” they added.

Last Updated January 10, 2020

Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

Primary Source

JAMA

Source Reference: Schermerhorn ML, et al “Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis” JAMA 2019; DOI: 10.1001/jama.2019.18441.

Secondary Source

MedPage Today

Source Reference: Lou N “Study: Transcarotid Stenting Has a Leg Up Over Femoral Approach” 2019.

https://www.medpagetoday.org/cardiology/pci/84281?_ga=2.236002504.831987228.1578674207-1125047970.1528569052

Bloomberg sees California as model for U.S.

Mike Bloomberg’s plan for California – export it.

The Democratic presidential candidate and former New York City mayor likes a lot of what he sees in the Golden State and thinks its efforts on climate change, gun control and criminal justice reform sets a benchmark for other states to emulate.

“I think that California can serve as a great example for the rest of this country,” Bloomberg told supporters at the opening of his Angeles headquarters.

Yes, there are problems, including homelessness, struggling public schools and scarce, costly housing. But California “is something the rest of the country looks up to,” Bloomberg said. “California has been a leader in an awful lot of things.”

His comments marked a sharp departure from views of President Donald Trump, whose administration has been in a long-running feud with the nation’s most populous state over issues from environmental protection to homelessness. Trump called California “a disgrace” last year shortly after its Democratic-controlled Legislature passed a bill that would have required presidential candidates to release their tax returns to get on the 2020 ballot, a proposal aimed squarely at the president. It was later voided in court.

Bloomberg’s visit came as part of a swing through a state that he sees as central to his hopes of winning the White House. After a late entry into the race, Bloomberg is bypassing the first four primary and caucus states and is anchoring his strategy to California and other Super Tuesday states on March 3.

His TV ads have been appearing routinely on television, attempting to connect with voters who might know little or nothing about the billionaire businessman.

With more delegates than any other state, California “has a lot of power in the nominating process,” Bloomberg noted.

https://www.washingtontimes.com/news/2020/jan/6/michael-bloomberg-sees-california-model-us/

40% of patients would switch physicians for more affordability — survey

If access to more affordable payment options were available, 2 in 5 patients would switch providers, according to a survey published by AccessOne, a patient portal.

That number is on the rise, according to the survey, which includes responses from more than 1,000 consumers. In 2018, 33 percent of individuals said the same. The survey also found 75 percent of consumers are willing to shop care prices, and 38 percent already do.

Across generations, baby boomers are less likely to switch providers if more affordable payment options are provided. Still, 55 percent of baby boomer respondents said they consider transparency on out-of-pocket costs a key part of choosing a provider.

https://www.beckershospitalreview.com/finance/40-of-patients-would-switch-physicians-for-more-affordability-survey-finds.html

How controlling fat ‘doormen’ could lead to new obesity treatments

In healthy people, fat cells take in nutrients and let out energy-supplying lipids in a finely tuned process that prevents the excessive buildup of belly fat. When this process goes wrong, however, obesity can emerge.

Scientists at Yale University have discovered a new regulator of fat transport—an enzyme they believe could be targeted with drugs to help control obesity. They described the discovery in the journal Nature Communications.

The enzyme is called O-GlcNAc transferase (OGT), and its role in maintaining a healthy metabolism has been widely reported. In 2015, for example, a Johns Hopkins University team discovered that high levels of OGT disrupt energy production in a way that leads to high blood sugar.

The new study from Yale focuses on OGT’s impact on “fat droplet sentinels,” which are molecules inside of fat cells that act like “doormen” for nutrients and fat, according to a statement from the university. The researchers discovered mice that lack the enzyme are lean and their cells burn off lipids at a faster rate than they take in carbohydrates. Mice that overexpress OGT, by contrast, take in more carbohydrates, they reported.

“The commander of this doorman makes it easier for nutrients to get in, but harder for lipids to get out,” said senior author Xiaoyong Yang, Ph.D., associate professor of comparative medicine and of cellular and molecular physiology at Yale’s medical school, in a statement.

Yale has undertaken a variety of research efforts aimed at reducing the buildup of unhealthy fat in the body. In 2018, a team at the Yale Cardiovascular Research Center published a mouse study that showed that inhibiting the VEGF-A receptor FLT1 normalized fat transport in the body and prevented weight gain.

As for OGT overexpression, it doesn’t just control the flow of nutrients and fats. It also sends signals to the brain that trigger overeating, Yang’s team previously discovered. “This makes OGT a very attractive target to pharmaceutically treat obesity,” he said.

https://www.fiercebiotech.com/research/how-controlling-fat-doormen-could-lead-to-new-obesity-treatments

U Va. plan to cut hospital readmissions picked for national AI competition

A UVA Health proposal to reduce hospital readmissions was among 25 submissions chosen – from more than 300 applications – for a national competition seeking ideas on how artificial intelligence can improve healthcare.

The UVA Health data science team will compete alongside proposals from organizations that include IBM and Mayo Clinic in the first Centers for Medicare & Medicaid Services Artificial Intelligence Health Outcomes Challenge. UVA’s project seeks to not only predict which patients are at risk for being readmitted to the hospital multiple times, but suggesting a personalized plan to prevent those readmissions.

Artificial Intelligence is a vehicle that can help drive our system to value – proven to reduce out-of-pocket costs and improve quality. It holds the potential to revolutionize healthcare: imagine a doctor being able to predict health outcomes – such as a hospital admission – and to intervene before an illness strikes. The participants in our AI Challenge demonstrate that such possibilities will soon be within reach. We congratulate the 25 innovators who have been selected to continue, and we look forward to seeing what else they have in store.”

Seema Verma, CMS Administrator

Predicting and preventing readmissions

An analysis by the UVA Health data science team developing the proposal found that 3% of patients at UVA account for 30% of readmissions within 30 days of being discharged from the hospital. Most of those return hospital visits occur within 12 months of the first admission, so being able to predict which patients are at risk for multiple readmissions is vital.

One challenge is that not all readmissions can be stopped; published research estimates that less than one-third of readmissions within 30 days of discharge from the hospital are actually preventable. For example, elderly patients are at higher risk for readmissions, but there’s nothing that can be done about a patient getting older.

Based on an analysis of data from insurance claims and electronic medical records – and building on work they have already done to reduce readmissions – the UVA Health team has identified several risk factors that can be addressed.

For example, a patient may not be taking full advantage of preventive care options, may have chronic conditions such as diabetes or may not be able to effectively manage their due to medical illiteracy or other factors. A patient’s risk for readmission may also vary based on why they are coming to the hospital. For instance, a patient with cancer coming to the hospital for a regular chemotherapy session would be at lower risk than if the same patient was admitted to the hospital with a hip fracture.

But the model doesn’t stop with identifying patients at increased risk for multiple readmissions. “The core idea of our proposal is to suggest possible interventions,” said Bommae Kim, PhD, a UVA Health senior data scientist. “For example, a patient may have dementia and can’t take care of themselves. So we may talk with a caregiver about different care options or help find other resources to help the patient.”

Refining their work

The UVA Health team has until February 2020 to submit their updated proposal to CMS. Later next year, they will learn whether they were selected as 1 of 7 finalists to compete for a $1 million grand prize. But the opportunity to build on the team’s efforts over the past five years to incorporate AI into patient care has already proved valuable.

“Just putting together the proposal is helping us accelerate our work to improve care for our patients,” said Jonathan Michel, PhD, UVA Health’s director of data science.

Source:

University of Virginia Health System

https://www.news-medical.net/news/20200111/UVA-Health-proposal-to-reduce-hospital-readmissions-selected-for-national-AI-competition.aspx