Dem bill to hold platforms accountable for misinformation during health crises

 Democratic Sens. Amy Klobuchar (Minn.) and Ben Ray Luján (N.M.) introduced a bill Thursday that aims to hold tech companies accountable for spreading health misinformation as the federal government continues to push for Americans to get COVID-19 vaccines. 

The bill would create an exception to a part of a controversial bill, known as Section 230 of the Communications Decency Act, that provides tech companies a legal liability shield over content posted by third parties. The proposal would create an exception for platforms that have algorithms that promote health misinformation related to an existing public health emergency.

“The coronavirus pandemic has shown us how lethal misinformation can be and it is our responsibility to take action,” Klobuchar said in a statement. 

The bill is not Klobuchar’s first proposal that aims to reform Section 230. Earlier this year she introduced a bill that would remove some of the protections provided to platforms by allowing users who face cyberstalking, targeted harassment and discrimination to seek legal action against the platforms. 

The new proposal, dubbed the Health Misinformation Act, would also direct the Department of Health and Human Services to issue guidelines as to what constitutes health misinformation. 

The proposal will likely face a rocky path forward, with lawmakers largely divided along party lines over how to reform Section 230. 

It may also be difficult for users even if the shield were lifted in such cases to successfully sue platforms over health misinformation. This is not illegal, as opposed to reform measures that would allow for cases against the tech companies over posts including child pornography or defamatory statements. 

But the bill could still send an important signal to the tech giants, according to Paul Barrett, the deputy director of the NYU Stern Center for Business and Human Rights

“The potential benefit of the Klobuchar-Lujan bill is not that it would lead to a flood of litigation. It would still be very difficult to win a lawsuit against Facebook or Twitter. Instead, the potential benefit would be the unmistakable signal the law would send that the social media platforms must stop amplifying public health misinformation,” Barrett said in a statement.

The bill also indicates Democrats are not backing down from pressing tech companies to address COVID-19 misinformation. 

“As COVID-19 cases rise among the unvaccinated, so has the amount of misinformation surrounding vaccines on social media. Lives are at stake,” Luján said in a statement. 

The push comes just a week after the surgeon general released an advisory calling the spread of coronavirus misinformation an “urgent threat.” The advisory in part urged social media platforms to take greater action to combat the spread of false information about the virus and vaccines. 

Following the advisory, President Biden got into a heated back-and-forth with Facebook after the president accused the platform of “killing people.” He later walked back the comments but urged the platforms to still take action to combat misinformation. 

Facebook has defended its policies put in place to combat the spread of coronavirus misinformation, despite urging for more action from Democrats and advocacy groups. 

The social media giant has boasted that it has connected “more than 2 billion people” with authoritative information about COVID-19 and vaccines, and that more than 3.3 million Americans have used its vaccine finder tool.

The CEO of the Center for Countering Digital Hate (CCDH), which released a report earlier this year about the spread of anti-vaccine misinformation, cheered the Democrats' bill.

“This bill gives a pathway to restitution for harm caused by a failure to act on clear, extraordinary national public health threats such as Covid. Given platforms already claim they are doing this, they shouldn’t fear this legislation. Any trepidation they feel is entirely because of their failure to live up to the standards and expectations they claim to adhere to,” CCDH CEO Imran Ahmed said in a statement.

But the CEO of tech industry group Chamber of Progress, which lists Facebook, Twitter and Google among its corporate partners, said Democrats “would regret” making such reform if a Republican administration took office.

“We all want less misinformation online, but this approach would turn future Republican presidents into the speech police,” Chamber of Progress CEO Adam Kovacevich said in a statement.

“When President Ron DeSantis' HHS Secretary deems pro-choice and transgender speech 'misinformation,' Democrats would regret this,” Kovacevich added, referring to the Florida governor who is seen as a potential GOP presidential candidate in the next election.

https://thehill.com/policy/technology/564395-klobuchar-bill-would-hold-online-platforms-accountable-for-misinformation

Miss. AG asks Supreme Court to overturn Roe v Wade

 Mississippi’s attorney general urged the Supreme Court in a Thursday brief to overrule Roe v. Wade next term when the justices review Mississippi’s ban on virtually all abortions after 15 weeks of pregnancy.

Calling the court’s precedent on abortion “egregiously wrong,” Attorney General Lynn Fitch (R) explicitly set the dispute over Mississippi’s restrictive law on a collision course with the landmark 1973 decision in Roe that first articulated the constitutional right to abortion.

“This Court should overrule Roe and Casey,” Fitch wrote, referring also to the court’s 1992 decision in Planned Parenthood v. Casey. “Roe and Casey are egregiously wrong. They have proven hopelessly unworkable. … And nothing but a full break from those cases can stem the harms they have caused.”

Supreme Court precedent tracing back to Roe prohibits states from banning abortion before fetal viability, which occurs around 24 weeks. The Mississippi law to be reviewed during the court’s upcoming term, which begins in October, creates only narrow exceptions from its 15-week ban. 

“The court cannot uphold this law in Mississippi without overturning Roe’s core holding,” Nancy Northup, president of the Center for Reproductive Rights, told reporters in May when the court took up the case. “The stakes here are extraordinarily high.”

The Mississippi restriction, passed in 2018, is just one of hundreds of abortion measure state legislatures passed in recent years, many with the explicit goal of overturning Roe v. Wade. This year alone, lawmakers in 46 states have introduced more than 500 abortion restrictions, according to an April analysis from the Guttmacher Institute. Of those, more than 60 measures have been enacted.

Abortion rights advocates have warned that overturning Roe would have a cascading effect at the state level, where anti-abortion activists have been carefully preparing for just such a contingency amid the Supreme Court’s conservative shift over recent years.

A decision in the case, Dobbs v. Jackson Women's Health Organization, is expected in summer 2022.

https://thehill.com/regulation/court-battles/564436-mississippis-attorney-general-asks-supreme-court-to-overturn-roe-v

FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain

 

• FDA has called for new powers and more funding to improve its ability to prevent medical device shortages.
• Janet Woodcock, the acting FDA commissioner, said in a Wednesday statement the pandemic "exposed great weaknesses in the medical device supply chain" that the U.S. needs to resolve to ensure it is better prepared for future crises.
• In addition to $21.6 million for a shortage prevention program, part of the agency's fiscal year 2022 budget request, Woodcock wants Congress to give FDA "expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage."

Woodcock's statement setting out the need for more money and powers comes a day after giving testimony to the Senate Committee on Health, Education, Labor, and Pensions. At that meeting, Woodcock described the work FDA did to ensure the supply of medical devices during the pandemic. 

The volume of COVID-19 emergency use authorization requests for medical devices quickly rose to "two orders of magnitude" higher than the peak of any previous public health emergency, Woodcock said in the hearing testimony. To help manage the workload, FDA revised its EUA review processes to "incorporate the latest information on device availability and shortages."

The changes led FDA to prioritize devices that could help address significant shortages. 

Woodcock hailed areas she thinks FDA did well, such as the awards of EUAs to 13 decontamination systems for personal protective equipment to ease supply constraints on face masks and other devices needed to protect healthcare professionals from the coronavirus.

Yet, Woodcock also sees opportunities to improve the response to future crises.  

"The pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices. To ensure the U.S. is properly prepared now, and in the future, we must take action to secure our medical device supply chain, including related materials, parts, and components. The FDA recognizes that this will take resources and expanded authority," Woodcock wrote in the blog post.

The acting FDA commissioner cited differences between FDA's powers related to drugs and devices to make the case for expanded authority. "The temporal limitation and tie to public health emergencies for manufacturers to submit device shortage notifications puts the FDA behind in responding to early signs of supply constraints or a potential shortage," she noted.

COVID-19 outbreaks abroad meant the U.S. experienced supply disruptions before facing its own public health emergency.

FDA wants the power to obtain supply disruption notifications for critical devices whenever there is the potential for a shortage, regardless of whether the U.S. faces a public health emergency.

The agency also wants notifications to include "production volume information to help facilitate conducting fuller oversight of supply chain disruptions," Woodcock said, and to have the power to make manufacturers develop and share risk management plans.

Under Woodcock, FDA is also seeking money for a Resilient Supply Chain and Shortages Prevention Program. The program is intended to equip FDA to prevent and mitigate supply chain interruptions using approaches such as predictive modeling and early signal detection.

https://www.healthcaredive.com/news/fda-seeks-funds-powers-to-fix-great-weaknesses-in-medical-device-supply/603806/

Oncology group presses CMS to roll back payment cuts, changes to controversial pay model

 A top oncology group is calling on the Biden administration to halt a 22% reduction in payments for high-grade radiation treatments and $160 million in cuts proposed for a mandatory payment model.

The American Society for Radiation Oncology (ASTRO) released a statement Tuesday decrying the proposals in the Physician Fee Schedule released last week and changes to the Radiation Oncology Model outlined in the Hospital Outpatient Prospective Payment System rule released on Monday. The group said that the cuts are harmful for radiation oncologists especially in light of the pandemic.

“Access to life-saving cancer treatments will suffer, and the viability of clinics already reeling from the pandemic will be at considerable risk if these proposals are finalized,” said Thomas J. Eichler, chair of ASTRO, in a statement Tuesday.

The group warned about a series of changes to the payment methodology associated with the model, which aims to reimburse hospital outpatient sites and physician group practices that include freestanding radiation therapy centers for total episodes of care. The model will make site-neutral, prospective payments for certain radiation therapy services and treatments.

The payments are split into professional and technical components. The professional payment is intended to reimburse providers for the services made by a physician, and the technical payment is for those not furnished by a physician.

But ASTRO charged that the Centers for Medicare & Medicaid Services has set the payment methodology to be too punitive.

The agency is proposing to set the discount factors for model participants at 3.5% for the professional component and 4.5% for the technical component. The model originally had the discount factor of 3.57% for professionals and 4.75% for the technical component.

The discount factor is the percentage where CMS “reduces an episode payment amount, reserves savings for Medicare and reduces beneficiary cost-sharing,” according to a fact sheet on the model.

ASTRO believes the discount factor is set too high, especially in context with other models.

“Other payment models that [the Center for Medicare & Medicaid Innovation] released has included risk factors or discounts that are significantly less,” said Anne Hubbard, director of health policy for ASTRO, in an interview with Fierce Healthcare.

Another issue is that the model is mandatory and “has never been tested,” Hubbard added. “Practices automatically have payments withheld, 3% on practice side and 1% on technical side associated with quality measure performance.”

The Physician Fee Schedule also called for a cut to high-value radiation treatments by as much as 22%, ASTRO said.

Hubbard noted that the cuts are coming at a point when radiation oncology services are down 8% due to the pandemic.

“You are talking about some pretty serious cuts on practices that have been through significant reductions resulting from a public health emergency that everybody is struggling through,” she said.

ASTRO has been a staunch opponent of the model, which Hubbard said doesn’t fully comprehend the costs that radiation oncologists face.

“Our practices have high capital costs,” Hubbard said. “This model because of these cuts doesn't recognize that those capital costs are not variable. They are there regardless of patient volumes or what have you. There is no way to recognize the fact that for some specialties there is limited amount of variable cost to decrease to generate savings for Medicare.”

Congress in a spending bill last year pushed back the start date of the model from July 1, 2021, to Jan. 1, 2022.

Hubbard said that the organization is considering another push to CMS and Congress for modifications to the model.

https://www.fiercehealthcare.com/payer/oncology-group-presses-cms-to-roll-back-payment-cuts-changes-to-controversial-payment-model

Merck taps Evidation to use apps, wearables to detect early stages of Alzheimer's

 Merck has tapped Evidation to explore whether data collected from smartphone apps and wearables can help to diagnose Alzheimer’s disease early.

 
The two companies are partnering to research whether sensor data can be used to develop digital measures to accelerate drug development for the disease.
 
The work builds on Evidation’s previous research characterizing neurodegenerative disease using data from digital sensors and apps.
 
“We know that digital measures have the potential to make visible what is currently clinically invisible. This is an important, early step towards accelerating the development of new therapies for neurodegenerative diseases, and, together with Merck, we are committed to better understanding, diagnosing, and treating Alzheimer’s Disease at its earliest detectable stages,” Deborah Kilpatrick, Co-CEO of Evidation, said in a statement.
 
Merck and Evidation will initially collect data from smartphones and wearable devices from elderly individuals with and without cognitive impairment. Researchers plan to test whether the data collected remotely can differentiate between populations and understand variability and changes across individuals and over time.

 “Advances in passive remote monitoring are providing new compelling opportunities to identify novel endpoints and digital biomarkers for Alzheimer’s disease,” said Dr. Michael Egan, vice president, Neuroscience Global Clinical Development, Merck Research Laboratories in a statement.

“This collaboration with Evidation will allow us to explore new and potentially faster ways to evaluate the potential of candidates in development for the treatment of Alzheimer’s disease,” Egan said.
 
Current scientific understanding of Alzheimer’s disease suggests that pathophysiological changes, as well as subtle changes in cognition, sensory, and motor function associated with disease onset, are initiated years before the disease is typically clinically recognized. Evidation’s past research shows that smart devices may be useful tools in detecting neurodegenerative diseases before they manifest in a clinical setting.

Launched in 2012, Evidation's platform incorporates information from more than 100 continuous data sources, including patients’ own smartphones, wearables and reported outcomes, and links them with electronic health records, insurance claims, environmental reports and the rest.

Evidation’s data platform ingests over 1 trillion data points annually, drawn from millions of participants across different disease areas, and feeds them through a virtual study design and execution engine that’s compliant with federal privacy and research regulations and good clinical practices.

The startup has worked with other life sciences companies on using sensor data for medical research. In 2019, the company, along with Eli Lilly & Co. and Apple, released initial study results that showed that a combination of consumer devices and mobile apps could potentially help spot people with mild cognitive impairment or mild dementia related to Alzheimer’s, FierceBiotech reported.

Last year, the U.S. government’s experimental medical research arm teamed up with Evidation to develop a digital means of detecting a person’s early symptoms of COVID-19. 

Earlier this year, the company banked a $153 million funding round to accelerate its work, including building out its digital Achievement program, which signs up participants for research studies from a pool of over 4 million users.

https://www.fiercehealthcare.com/digital-health/merck-taps-evidation-to-use-apps-wearables-to-detect-early-stages-alzheimer-s

Tenet Healthcare: Volumes recovery unthreatened by resurging COVID-19

 Tenet Healthcare executives shrugged off the threat of rising COVID-19 cases after another quarter of swelling profits, revenues and volumes led the for-profit system to raise its guidance for the remainder of 2021.

“The second quarter and the first half of 2021 have been better than expected on many fronts,” CEO and Executive Chairman Ron Rittenmeyer said during a Thursday morning investor call.

“Clearly the variants coupled with the unvaccinated individuals has resulted in an uptick in certain parts of the country. Our COVID inpatient numbers remain low—roughly 4% of our total cases as of now—and while we’ve seen increases in select markets, given our experience, we’re really able to manage through this like we did when we were hit with other waves earlier last year. We have sufficient [personal protective equipment] on hand, we have sufficient capacity across every market and facility and we remain vigilant of any changes that might occur,” he said.

Tenet reported $120 million in net income from continuing operations for the second quarter of 2021 ending on June 30—a 36% increase over the $88 million reported in the same quarter of 2020 and a 23% jump over the $97 million reported in the first quarter of 2021.

The company noted that its profits include $24 million in pretax COVID-19 stimulus funding during the most recent quarter. It had received $523 million in pretax stimulus grant income during the same quarter last year.

Overall net operating revenues for the latest quarter landed just shy of $5 billion. This was a roughly 36% increase over last year’s $3.6 billion and about 3% more than the almost $4.8 billion reported in 2021’s first quarter.

Net operating revenues for the company’s hospital segment were just shy of $4.1 billion for the quarter, versus almost $3.1 billion during the second quarter of 2020 and $3.9 billion in the first quarter of 2021. Ambulatory service revenues hit $664 million, up again from last year’s $368 million and the first quarter of 2021’s $646 million.   

Hospital admissions were up 13.7% compared to the same period during the prior year and, year-to-date, are just a hair higher than last year at a 0.1% increase.

This is a marked turnaround from the volumes hit Tenet suffered during the second quarter of 2020, when admissions dropped 20.3% compared to the year prior.

Tenet also reported year-over-year volume gains for its outpatient visits (70.6%), emergency room visits (35%), hospital surgeries (37%) and same-facility system-wide surgical cases for its ambulatory surgery business (68.2%).

“We are delivering a much stronger growth trajectory on the hospital side in terms of admissions and outpatient visits, ER volumes and surgeries,” Rittenmeyer said. “In particular, the higher acuity work that we have been focused on with general surgery, cardiovascular, ortho, neuro, etc., have been steadily progressing in key markets across the country.”

While the rebound in volumes has steadily increased across Tenet’s entire portfolio, some regions are rebounding from COVID-19 disruptions at a faster pace than others, the CEO said. Tenet doesn’t put out volume or earnings data for specific markets, but Rittenmeyer advised investors to consider the lockdowns and case counts of the surrounding communities for a rough idea of their progress.

“If you think about the portfolio and the markets that have opened up more quickly, you can safely assume that our performance is above average there,” he said. “And in the states that have been slower, have had more of a prolonged lockdown or have had, in some cases, more difficulties with vaccination in urban areas and things like that, they’re probably a little behind the average.”

Rittenmeyer went on to say that the month-to-month gains in patient volumes and the numbers from Tenet’s highest performing markets has the company “very confident” that its business will exceed 2019’s earnings once COVID-19 has run its course. He also noted that the company has not seen any demand for procedure cancelations from patients or physicians related to rising case counts.

Dallas-based Tenet Healthcare currently operates 65 hospitals. It employs 108,000 people across its hospitals, more than 450 other healthcare facilities and Conifer Health Solutions, its revenue cycle management and value-based care services group.

Last month Tenet announced plans to sell off five of its hospitals to Steward Health Care for $1.1 billion, a deal set to close in the third quarter of 2021. In April it wrapped up the sale of its urgent care platform to FastMed for $80 million.

Daniel Cancelmi, Tenet’s chief financial officer, noted that proceeds from the hospital divesture could be used to pay off some of the system’s debt or to secure potential growth opportunities across higher acuity service lines.

“Reinvesting in the company is our biggest objective at this point,” he said.

Looking ahead, Tenet has upped its third-quarter and full-year financial guidance for shareholders.

For the former, the company expects net operating revenues to land between $4.6 billion and $4.8 billion, which takes into account lost revenue from the divestiture of its five Florida hospitals. Income is expected to fall between $335 million and $375 million.

For the full year, Tenet is anticipating its net operating revenues to run somewhere between $19.25 billion and $19.65 billion, while net income from continuing operations is thought to land within the $681 million and $781 million range.

https://www.fiercehealthcare.com/hospitals/tenet-healthcare-ups-its-profit-to-120m-alongside-recovering-volumes-q2-2021

Google Cloud rolls out technology to map medical records data to FHIR standard

 Large tech giants are jumping into a growing interoperability solutions market as new federal regulations spur the healthcare industry to open up and share medical records data.

Google Cloud rolled out a new tool called the healthcare data engine, currently in private preview, that helps healthcare and life sciences organizations harmonize data from multiple sources, including medical records, claims, clinical trials and research data.

It gives organizations a holistic view of patient longitudinal records, and enables advanced analytics and AI in a secure and compliant cloud environment, according to Google Cloud executives.

Data was a lifeline during the COVID-19 pandemic," Joe Corkery M.D., director of product management at Google Cloud, said during a recent call with reporters. "We can now see the full potential and vision of data interoperability."

Google Cloud developed the healthcare data engine to make it easier for healthcare and life sciences organizations to bring together their data silos to innovate and improve health outcomes, Corkery said.

The technology builds on the core capabilities Google started offering last year with its Cloud Healthcare API, a technology tool that will make it easier for health systems and providers to connect data across different sources and share those data with patients. 

The healthcare data engine can map more than 90% of Health Level 7 (HL7) v.2  messages to Fast Healthcare interoperability Resource (FHIR) standards—such as medication orders or patient updates—across leading electronic health records (EHRs) out of the box.  FHIR is the data standard specified in federal interoperability regulations.

This enables healthcare organizations to get up-and-running quickly and avoids the need to create custom tooling or services, according to executives. And bringing together siloed data enables innovation and interoperability, helping healthcare and life sciences organizations make better real-time decisions—whether it is around resource utilization, optimizing clinical trials, accelerating research, identifying high-risk patients and reducing physician burn out.

The technology also leverages Google BigQuery’s analytics and artificial intelligence to help organizations process and visualize petabytes of their own patient data, enabling a more holistic view of patients in surrounding communities and the potential to improve overall population health.

According to recent Google Cloud-commissioned research conducted by The Harris Poll, nearly 9 in 10 physicians (87%) say data interoperability should be a priority at their healthcare organizations right now, and 95% of physicians agree that access to more complete patient records helps them make diagnoses more quickly and accurately. Most physicians (90%) say they would be able to provide more personalized care for their patients if they could reduce time reviewing or updating patient records by just 5%. 

"What we see out in the market, historically organizations have relied on enterprise data warehouses to do this kind of retrospective analytics, but today's use cases need less data latency, they need to make faster sense of this proliferating data," Marianne Slight, product manager for Google Cloud Healthcare Analytics, said to reporters. 

Mayo Clinic has been working with Google Cloud to bring data in from disparate sources, harmonize it to FHIR format, and analyze it in BigQuery. By automating this process, what used to take weeks can be done in an hour, enabling Mayo Clinic’s experts to now focus on solving critical problems in health rather than managing IT resources, health system executives said.

“We were hitting a wall with our ability to innovate on-prem. By moving to the cloud we’re able to build tools more easily, at scale, in a way that takes advantage of technological advancements in security and privacy to remain at the forefront in data protection,” said Jim Buntrock, vice chair of information technology at Mayo Clinic in a statement. 

“There are so many applications of this. For example, building a ‘heads up display’ for the ICU—where moments matter—to help care teams direct their attention when and where it’s needed most. From creating better ways to care for patients remotely even after they leave the hospital to making it easier for patients to interact with us via mobile app, we’re working alongside Google Cloud to build a platform for healthcare transformation.” 

Healthcare Data Engine is being used today by healthcare organizations such as Indiana University Health. 

Google Cloud's release of the API and the healthcare data engine comes as federal policymakers are pushing the industry to open up healthcare data and share them with patients or the health apps patients choose.

Microsoft also launched a cloud service designed specifically for healthcare that helps organizations scale up digital health technologies while also providing tools to improve data interoperability, workflow efficiency, and streamline interactions, the company said. 

Amazon also recently announced the general availability of Amazon HealthLake, a tool to make it easier for healthcare organizations to search and analyze data.

And Apple rolled out a new iPhone feature that enables consumers to share health data directly to their provider’s EHR system through the Apple Health app. The key to Apple's integration with medical records software companies is the use of standard application programming interfaces (APIs) — namely, SMART on FHIR.

https://www.fiercehealthcare.com/tech/google-cloud-rolls-out-technology-to-map-medical-records-data-to-fhir-standard