Moderna Inc. (MRNA) shares dove more than 5% in after-hours trading Thursday, after the company announced that a study into a flu vaccine candidate failed to reach one of its goals. The company said that the candidate accomplished superiority in two goals and non-inferiority in another, but did not reach the non-inferiority standard on the other goal of the study. "While we did not achieve non-inferiority for the Influenza B strains which are more frequent in younger populations, we have already updated the vaccine that we believe could improve immune responses against Influenza B and will seek to quickly confirm those improvements in an upcoming clinical study thanks to the agility of our mRNA platform," Moderna President Stephen Hoge said in a statement. Moderna shares are up 13.5% in the past 12 months, as the S&P 500 index has declined 7.3%.
Thursday, February 16, 2023
Iveric: Priority Review for Avacincaptad Pegol for Treatment of Geographic Atrophy
IVERIC bio, Inc. (Nasdaq: ISEE) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for avacincaptad pegol (ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of August 19, 2023. The company also announced that, at this time, the FDA has not identified any potential review issues and the FDA is not currently planning to hold an Advisory Committee meeting for ACP.
https://finance.yahoo.com/news/iveric-bio-announces-fda-accepts-210100180.html
CMS halts, recalls billing arbitration decisions after Texas court vacates guidance
The Centers for Medicare & Medicaid Services have instructed arbitrators for out-of-network payment disputes to pause and recall certain payment determinations due to a recent court decision striking down key parts of the agency’s surprise billing regulations.
CMS said in a Friday notice that its departments “are in the process of evaluating and updating” implementation of the Federal Independent Dispute Resolution process to be consistent with a Feb. 6 ruling from the U.S. District Court for the Eastern District of Texas.
The court agreed with the provider plaintiff, the Texas Medical Association, that CMS once again went against the congressional intent of 2020’s No Surprises Act.
The law banning surprise medical bills went into effect at the top of 2022, though CMS has now been forced to amend arbitration—its process for settling payment disputes between providers and payers—for a second time.
Specifically, rules released by CMS outlining how an independent third party should choose between the amounts proposed by each side were successfully contested in court by providers for too heavily weighing on the qualified payment amount, which favors payers.
“[CMS’ final rule released in Aug. 2022] continues to place a thumb on the scale for the QPA by requiring arbitrators to begin with the QPA and then imposing restrictions on the non-QPA factors that appear nowhere in the statute,” Judge Jeremy Kernodle wrote in last week’s decision.
The summary judgment granted by Kernodle vacated certain portions of the rule and remanded it back to CMS.
As a result, CMS instructed arbitrators on Friday to immediately stop issuing new payment determinations until further guidance is available. Further, arbitrators should recall any payment determinations that were issued after Feb. 6, the date of Kernodle’s decision, CMS wrote.
Other parts of the dispute resolution process remain fair game for arbitrators as they await additional direction from CMS, the agency wrote.
The court’s decision to send back arbitration guidelines for a second time was welcomed by the hospital industry. Melinda Hatton, general counsel for the American Hospital Association, said in a statement last week that her group hopes CMS will now “work with hospitals and health systems to implement the fair process Congress intended.”
The Texas Medical Association, meanwhile, has other issues with the administration’s implementation of the No Surprises Act, having recently filed another lawsuit challenging increases to the administrative fees charged when a provider or payer initiates an arbitration dispute.
Doximity beta version of ChatGPT for docs aims to streamline administrative paperwork
The internet is buzzing with news about ChatGPT, an artificial intelligence large language model developed by OpenAI, and its potential uses in medical practice and education.
Doximity, a digital platform for medical professionals, rolled out a beta version of a ChatGPT tool for doctors that helps streamline some of their time-consuming administrative tasks, such as drafting and faxing preauthorization and appeal letters to insurers.
The open beta site, called DocsGPT.com, is an integration with ChatGPT that works with Doximity’s free fax service, said Jeffrey Tangney, Doximity co-founder and CEO, during the company's fiscal 2023 third-quarter earnings call Thursday.
The company worked with doctors to fine-tune the product, he said.
Doximity engineers began working on the beta site over the holidays, Tangney said, and the tool was announced this week during the earnings call.
"Like many others, we are very excited about the potential applications of generative AI in health care. We know how busy physicians are and recognize that administrative burden is a leading contributor to burnout. Our mission is to help physicians be more productive so they can focus on what matters the most—spending more time with their patients," Nate Gross, M.D., co-founder and chief strategy officer at Doximity, told Fierce Healthcare via email.
"We had an opportunity to speak with a number of physicians and a very familiar use case quickly bubbled up: doctors still handle a lot of paperwork and much of it is still sent via fax machines," he said.
At least 70% of healthcare providers still exchange medical information by fax, according to federal officials.
Using the free open beta site, doctors who are Doximity members can fax letters directly to insurers with the company's digital fax service. The site features a growing library of best medical prompts where the AI-based writing assistant has been trained on healthcare-specific prose.
Examples of medical prompts on the site include drafts of letters to insurance companies to get prior authorization for medications and other services, appeal denials, medical disability letters, post-procedure instructions for patients and even treatment instructions for children with asthma written as a rhyme in the style of Dr. Seuss.
The library of prompts ranges from clinical correspondence to progress notes to patient education to help doctors with charting and to draft communications to colleagues and patients.
Many of the initial prompts available on DocsGPT.com are based on real-world feedback from Doximity's physician members, Gross said.
"From appealing an insurance denial for a patient with a chronic condition to referring a patient to a specialist for further evaluation, there are many tasks that DocsGPT can help streamline with fewer disruptions to physicians’ clinical workflow," he said.
Doximity, which claims to have more than 80% of doctors on its network, has been working on a number of innovations to assist physicians. The company announced it is integrating with scheduling automation leader Calendly to help physicians schedule appointments with colleagues.
The company posted strong third-quarter results despite macroeconomic headwinds. But the company's stock slumped Friday, dropping 14% as investors were disappointed in Doximity's forecast. For the quarter, Doximity's revenue grew 18% to reach $115.3 million. The company reported quarterly earnings of 22 cents per share, beating Wall Street estimates of 17 cents per share.
However, Doximity executives said the company encountered unexpected delays in the approval of some of its vertical video products, which are subject to medical legal reviews. This will result in a 2% hit to its full-year revenue guidance.
The company reined in its full-year revenue guidance. For fiscal 2023, Doximity now expects revenue in a range of $417.7 million to $418.7 million, down from $424 million to $432 million. For the fourth quarter, the company expects revenue to reach $109.6 million to $110.6 million revenue, and, for fiscal year 2024, its revenue outlook stands at more than $500 million compared to $122.2 million and $523.6 million estimated by analysts, respectively.
ChatGPT launched last November, and many doctors already have been testing it out to see whether the AI-based chatbot could help with the tasks that doctors need to do regularly.
At the end of November, Clifford Stermer, M.D., a rheumatologist, demonstrated in a TikTok video how ChatGPT could save time with insurance denials, and the video went viral as it was widely shared on other social media sites.
However, many physicians and researchers have cautioned that the technology has major limitations, specifically that medical citations are often inaccurate, as Stermer explains in this updated TikTok video. ChatGPT can pull primary and secondary references from the medical literature and include these in letters to insurance companies, but the bot has been known to make up references, doctors say.
On the DocsGPT beta site, Doximity notes to physician users that "the letter content is AI-generated" and suggests that doctors "make sure to review and ensure accuracy" of the letter before it is submitted.
To use the fax service, Doximity members draft a letter using ChatGPT and then log into the company's HIPAA-compliant portal where they can review and edit AI-generated responses before they send the digital fax, Gross said.
"This means they can adjust the response to ensure accuracy and even add in patient information securely," Gross said via email.
Gross called the technology "very promising," but noted it's not without errors and "should still be approached judiciously."
"We aim to enable physicians to test and use this technology, so they can ultimately help ensure the best applications in a healthcare context," he noted.
David Canes, M.D., a urologist with Lahey Hospital and Medical Center in Burlington, Massachusetts, has tweeted and blogged about how he's used ChatGPT. He noted in his blog that time is a doctor's most valuable asset.
"The crux of the burnout problem, in my view, is that doctors have lost control over their time," he wrote, while providing extensive examples of how using the AI chatbot can help with day-to-day tasks.
Doctors still handle a lot of actual paperwork, and, in today’s healthcare system, much of it is still sent via fax and doctors often call this "scut work."
"By integrating DocsGPT with our free fax service, we hope to help medical professionals 'cut the scut'," Gross said.
During the earnings call, Tangney said early use of DocsGPT has been "promising."
"An oncologist from Ohio called DocsGPT a 'game changer' after it drafted an appeal letter for a cancer patient with a heart condition. The insurer got the fax and approved within the hour, allowing the patient to receive a non-generic medication with fewer cardiac side effects," the CEO told investors during the earnings call.
"Obviously, DocsGPT is just a small test project. But more broadly, we're enthused about AI's potential to streamline workflows across our entire platform," Tangney said.
With an eye toward accelerating breakthroughs in AI, tech giant Microsoft announced in January a “multiyear, multibillion dollar” investment into ChatGPT maker OpenAI. The investment is rumored to be as much as $10 billion.
Microsoft executives have hinted about potential uses for artificial-intelligence-powered language models in healthcare. Junaid Bajwa, chief medical scientist at Microsoft Research, told Analytics India Magazine that he sees ChatGPT as an answer to "solving various challenges in healthcare, offering more specific, personalized, and result-backed healthcare solutions, treatments, and consultations."
Last year, Microsoft bought voice technology company Nuance Communications for $19.7 billion. Nuance is considered a pioneer in speech recognition and artificial intelligence technology used in healthcare.
The hype about ChatGPT and its future in healthcare reached a fever pitch in December when an paper, published on medRxiv, found that the chatbot was capable of passing the U.S. Medical Licensing Exam. The peer-reviewed study published on Feb. 9 in the journal PLOS Digital Health. While no one is expecting the technology to replace doctors or nurses, it does demonstrate the potential for a tool like ChatGPT to help with administrative tasks or with diagnostics and treatment plans.
Gross emphasized that Doximity is developing DocsGPT with extensive input from physicians.
"DocsGPT is still in its very early stages, and that is by design. Too often physicians are not given a seat at the table in product development and new technologies designed to help them simply miss the mark. We know from over a decade of working side-by-side with physicians that our best ideas often come directly from them," he said.
He added, "We can’t wait to see where this technology leads us, but we still have a long way to go. As you might expect, the 'AI bar' is even higher in healthcare than it is in many other fields. To get this right, we must have the right partners and that includes physicians."
According to Doximity executives, several physicians have suggested that DocsGPT could save them and their staff up to two hours a day by streamlining administrative work they would otherwise have to do manually. "With a growing physician shortage issue and an aging population, we think the longer-term implications here could be significant. This type of feedback is very consistent with Doximity’s overarching goal—helping doctors be more productive so they can provide better care for their patients," Gross said.
In addition to insurance approvals, DocsGPT could be used to quickly generate templates for common administrative and documentation tasks, summarize and analyze medical articles or prepare study materials for medical students, Gross noted.
In response to a question from an investor about potentially monetizing the DocsGPT service, Tangney said it was a possibility down the road.
"You just think of all of those letters that need to be sent back and forth between insurers and providers, and we'd really love to help them out with that. It's really had a lot of warm accolades in a pretty short period of time," he said.
Medicare Advantage plans more likely to deny inpatient claims
The number of inpatient claims denied by payers is on the rise, with Medicare Advantage (MA) plans rejecting more claims than any other type of coverage, according to a new analysis.
Analysts at Crowe LLP, a global public accounting, consulting and technology firm, dug into claims data from 1,700 hospitals that use its Revenue Cycle Analytics tool and found that while traditional Medicare is one of the most straightforward payer categories for determining the appropriate level of care, MA plans use more restrictive methodology common in commercial plans.
Across all types of payers, the inpatient claim denial rate ticked up in 2022, representing 4.2% of billed inpatient dollars. That is an increase of 18.5% compared to 2021. Through November 2022, MA plans specifically denied 5.8% of inpatient claims based on level-of-care restrictions, compared to 3.7% for all other payer categories.
“Given the immense popularity of these plans, healthcare providers will have to adjust their clinical operations and should ensure their revenue cycle and care management teams are in alignment on which denied claims should be prioritized when managing appeals," Colleen Hall, managing principal of the healthcare group at Crowe, said in a release.
Providers were also more likely to write off reimbursements from MA plans, according to the analysis. When the researchers isolated the MA population, they found that providers wrote off 8.5% of inpatient revenue through November, compared to 4.7% in 2021.
Through November 2022, providers wrote off 5.9% of their inpatient revenue as unable to be collected, up 64% from 3.6% of inpatient revenue in 2021.
The Crowe team recommends that providers looking to buck this trend home in on preventive care and track data on which payers are responsible for the most claims denials with the goal of working with them to resolve these challenges. Keeping patients in the loop so they're aware of the status of their medical bills is also crucial, the analysts said in the report.
“One step that providers can take to try to prevent these reimbursement issues is to implement a physician adviser program to verify patient status and allow for peer-to-peer reviews to be completed when payors offer them,” said Hall. “This could help alleviate the administrative burden placed on them to defend the level of care, so hospitals can allocate more of their resources to caring for their patients.”
DEA: Drug cartels using Snapchat, other social media to target children
Lawmakers on Wednesday discussed how Mexican cartels are using social media as a “superhighway of drugs” to bring fentanyl to the U.S.
Experts called for a change in tech companies after the U.S. Drug Enforcement Administration said these cartels are targeting young Americans through social media platforms, fueling the fentanyl epidemic.
“The cartels understand that if someone dies from taking their deadly fentanyl, that there are 100 million other users on Snapchat that they can sell their drugs to,” said DEA administrator Anne Milgram, testifying before the Senate Foreign Relations Committee.
In her testimony, Milgram specifically named the Sinaloa and Jalisco cartels as being responsible for the U.S. fentanyl crisis, asking for Mexico’s cooperation in dismantling secret labs in their country.
“The cartels are sophisticated now in realizing that they don’t necessarily need to have people standing on street corners pushing their drugs,” said former FBI agent Stuart Kaplan.
“They can hide behind the social media platforms in a very secure and discreet way and push their drugs out to our younger generation, and almost do it with the immunity of no enforcement whatsoever.”
Kaplan explained that Snapchat stands out from other social media platforms because its messages are designed to disappear.
“I have two children, they both have smartphones. You will not find Snapchat on either one of their devices,” said Kaplan.
Amy Neville, whose 14-year-old son died after overdosing on a fentanyl-laced pill, says Snapchat was her son’s gateway to the drug and that the company needs to allow more transparency to hold them accountable.
Neville is now sharing her son’s story and trying to raise awareness.
“I believe Alexander may have known this drug dealer prior to his death, and they definitely connected through Snapchat. It was an easy way to order up some drugs for Alex and experiment, and it was super easy for this drug dealer to come right to our home and deliver them.”
Snapchat responded to the increased scrutiny, outlining their use of technology to help them find and shut down dealers’ accounts.
In a statement, a Snapchat spokesperson said, “We will continue to do everything we can to tackle this epidemic, including by working with other tech companies, public health agencies, law enforcement, families and nonprofits.”
Rubio, Banks introduce measure to ban some transgender people from military service
Top Republicans in the Senate and House introduced new legislation on Thursday that would ban some transgender people from serving in the military, reviving a similar policy that was enacted under the Trump administration.
The Ensuring Military Readiness Act, sponsored by Sen. Marco Rubio (R-Fla.), would disqualify Americans who identify as transgender, have a history of gender dysphoria or who have undergone gender reassignment surgery.
The legislation would force the Defense Secretary to issue an updated policy within 90 days of the bill’s enactment into law.
Exceptions include those who have been “stable in their biological sex” for 36 months prior to joining the military, meaning they no longer have a desire to transition and are not struggling with their mental health, and active military members who remain deployable according to their biological sex retention standards.
Active service members who have gender dysphoria on the date of the legislation’s enactment, as well as transgender people without a history of gender dysphoria, would be eligible to serve only under their biological sex.
Rubio said the military “has strict standards for who can and cannot qualify to serve,” comparing it to Americans with peanut allergies who are rejected from service.
“Biden has turned our military into a woke social experiment. It is a stupid way to go about protecting our nation,” Rubio said in a statement. “We need to spend more time thinking about how to counter threats like China, Russia, and North Korea and less time thinking about pronouns.”
Former President Trump announced a ban on transgender troops in 2017, the year he took office.
An official policy went into effect in 2019 barring troops from transitioning and requiring them to match their biological sex, leading to an outcry from human rights activists and LGBT organizations.
In January 2021, one of President Biden’s first actions was to repeal Trump’s policy, allowing those who identify as transgender to openly service in the military.
Defense Secretary Lloyd Austin praised Biden’s decision at the time, calling it the “smart thing to do.”
“I believe we accomplish that mission more effectively when we represent all our fellow citizens,” Austin said in a statement at the time. “I also believe we should avail ourselves of the best possible talent in our population, regardless of gender identity.”
In the House, Rep. Jim Banks (R-Ind.), the chairman of the House Armed Services Subcommittee on Military Personnel, will introduce companion legislation to Rubio’s bill.
Banks on Thursday disagreed with the Biden administration, saying the “military holds recruits to stringent medical standards for a reason.”
“The Biden administration’s special carveout for those suffering from gender dysphoria was purely political,” Banks said in a statement.
The proposed legislation would also require the Defense Enrollment Eligibility Reporting System, a database on service members, to require military personnel to identify with their biological sex.
Multiple LGBT rights organizations, including GLAAD, have repeatedly decried Republican-led efforts to restrict transgenders from serving in the military, calling them baseless attacks not rooted in fact.