Tag: 2023 News

While consumer VR remains a niche product and a massive money-burning venture for Meta CEO Mark Zuckerberg, CNBC reports that the technology is proving to be valuable in certain corners of health care. Kettering Health Dayton is one of dozens of health systems in the U.S. working with emerging technologies like VR as one tool for helping doctors to train on and treat patients.

Just days before assisting in his first major shoulder-replacement surgery last year, Dr. Jake Shine strapped on a virtual reality headset and got to work. As a third-year orthopedics resident at Kettering Health Dayton in Ohio, Shine was standing in the medical center’s designated VR lab with his attending physician, who would oversee the procedure.

Both doctors were wearing Meta Quest 2 headsets as they walked through a 3D simulation of the surgery. The procedure, called a reverse total shoulder arthroplasty, can last around two hours and requires surgeons to carefully navigate around neurovascular structures and the lungs.

For its orthopedics program, Kettering Health Dayton uses software developed by PrecisionOS, a company that builds VR modules for training surgeons, medical residents and medical device representatives. PrecisionOS co-founder and CEO, Dr. Danny Goel, said the company has nearly 80 customers across the globe.

Orthopedics residents at the University of Rochester also use PrecisionOS. Dr. Richard Miller, a retired professor at the university, said the software is “sophisticated” and “very realistic,” especially as a way to learn the steps of a procedure. He finds it so compelling that he’s been actively helping the orthopedics department implement the technology even though he retired three years ago.

Jan Herzhoff, Elsevier Health’s president, is quoted as saying that her company’s Complete HeartX mixed reality offering ”will help prepare medical students for clinical practice by using hyper-realistic 3D models and animations that help them understand and visualize medical issues, such as ventricular fibrillation, and how to apply their knowledge with patients.”

To date, one of the primary applications of VR in health care has been targeted at pain treatment.

“It’s very hard to keep track of pain when you’re in a fantastical cyberdelic world,” said Dr. Brennan Spiegel, director of health services research at Cedars-Sinai in Los Angeles. Spiegel said that when someone is injured, there is both a physical and an emotional component to their pain. Those signals are sent to two different parts of the brain, and VR can serve to tamp down the signals in both regions. “It’s training people how to modify their spotlight of attention so they can swing it away from the painful experiences,” Spiegel said. “Not just the physical, but the emotional experiences.”

Spiegel said Cedars-Sinai is preparing to launch a virtual platform to help people with gastrointestinal issues like Crohn’s disease, celiac disease or acid reflux, as well as others for anxiety, addiction and perimenopausal health.

The technology has also attracted the attention of the U.S. Department of Veterans Affairs, which is using extended reality at more than 160 facilities to help patients with pain management, behavioral therapy and both physical and cognitive rehabilitation. Caitlin Rawlins, the immersive program manager at the VA, said there are currently more than 40 separate use cases for the technology across the agency’s different sites. The VA first introduced extended reality in a limited capacity around 2015, and has found more opportunities to put it to use as the technology has improved.

“I’ve seen it change a whole lot,” Rawlins told CNBC in an interview. “The first virtual reality headset that I used was this big clunky headset that had all these wires it had to be connected to a laptop to function.”

Rawlins said what drew her to extended reality was seeing the immediate response from patients. She recalled the first time she watched a patient use VR. He was a man in his 80s who had just undergone knee replacement surgery. The pain was so severe that opioids didn’t help, Rawlins said.

After mere minutes in VR, he told Rawlins he couldn’t feel the pain in his leg anymore.

″Just using that for a simple 30-minute session can mean the difference between excruciating pain, unable to do the exercises and the ambulation that they need to, to actually get up and move and get ready to go home,” she said.

The Coalition to Protect Access to Care – what Politico reports as “an amalgam of monied health care interests that includes representatives for doctors, hospitals, health plans and other key players,”-  has filed paperwork to put a November 2024 ballot measure before voters, that would make permanent a tax on health plans and funnel the revenue to certain parts of the health safety net.

The coalition has until March or April to collect 546,651 signatures to qualify for the November ballot, and they’re already a few weeks behind other initiatives.

The coalition that secured a $36 billion tax deal to pump more money into Medi-Cal last June, that followed months of private negotiations between bitter industry rivals, state lawmakers and the governor’s office.wants to make it harder for future administrations to spend that revenue elsewhere.

The battle surrounds the California Managed Care Organization (MCO) tax. An MCO provider tax is a federally allowable Medicaid funding mechanism whereby a taxis imposed by states on health care services where the burden of the tax falls mostly on providers, such as a tax on managed care plans per members served. Provider taxes have become an integral source of financing for Medicaid nationwide.

In California the MCO tax has existed for nearly 20 years and been enacted by both Democratic and Republican governors. Recently AB 115 (Chapter 348, Statutes of 2019) and SB 78 (Chapter 38, Statutes of 2019) authorized a successor MCO tax from July 1, 2019, through December 31, 2022, similar to the 2016 MCO Tax. SB 78 (Chapter 33, Statutes of 2013) extended the MCO tax sunset date from June 30, 2011, to June 30, 2013.

California “taxes” MCOs, and uses the revenue to draw down federal matching funds to support the Medi-Cal program. Specifically, California:
– 1.Imposes a tax on all managed care plans per members served in a prior year.
– – a.The tax varies for Medi-Cal managed care plans compared to non-Medi-Cal managed plans or other managed care plans as seen in proposed budgetlanguage.
– – b.The fee also has tiers based on the number of members served by the managed care plan. Some tiers have no fee and some tiers cap the number of members the fee applies to in that tier.
– 2.Runs several “tests” based on federal rules to ensure the tax structure meets all federal requirements.
– 3.Increases the rates the state pays to Medi-Cal managed care plans to account for thetax. As such, there is no net impact to Medi-Cal managed care plans.
– 4.Uses the collected funds to secure a federal match to support the Medi-Cal program,which results in a General Fund gain.

According to the article in Politico, the last three times California levied this tax on health plans, it used the money to balance the budget during economic downturns. But after the Coalition entered the negotiations earlier this year, which led to the June 2023 agreement, and for the first time, much of the revenue stayed in the health care system, especially in Medi-Cal. – in a year when the state faces a $32 billion budget deficit.

That deal raised rates for primary care, OBGYN care and specialty mental health care and set aside money to cover such costs as emergency room physicians and ambulance services. The new ballot initiative preserves those priorities and adds more, like money for community health workers, specialty dental services, prescription drugs and some clinician and dentist loan repayments.

The ballot initiative sets out a spending plan that hews fairly closely to the priorities laid out in June’s iteration of the tax, which expires in 2026. It assumes that the tax will bring in around $4.3 billion when it’s renewed in 2027.

“We need to make sure that this is permanent and will last beyond the next several years and become something that providers and patients can count on for decades to come,” said Dustin Corcoran, CEO of the California Medical Association and chair of the coalition behind the initiative. “We don’t know what future administrations may or may not do.”

The ballot measure would make the MCO tax that expired on December 31, 2022, and then renewed by the negotiated outcome by industry rivals in June 2023, which will now otherwise expire in 2026 permanent. Any future changes would have to be approved by voters, making it harder for the state to update how it spends the revenue. The tax will be levied on California Managed Care Organizations (MCOs) who will no doubt pass those costs on to the price of ultimately paid on behalf of participants in one of the MCO organizations.  

CMS has indicated they will be issuing new MCO Tax guidelines that will be more restrictive no later than 2026.

The Alamitos Bay Yacht Club in Long Beach hired Brian Ranger as a maintenance worker. He helped the club with its fleet by painting, cleaning, maintaining, repairing, unloading, and mooring vessels.

One day, Ranger used a hoist to lower a club boat into navigable waters. He stepped from the dock onto its bow, fell, was hurt, and applied for workers’ compensation. Then he sued the club in state court on federal claims of negligence and unseaworthiness.

The trial court sustained the club’s final demurrer to the second amended complaint. The trial court ruled there was no admiralty jurisdiction.

The California Court of Appeal affirmed the trial court decision in the published case of Ranger v. Alamitos Bay Yacht Club -B315302 (September 2023).

Congress enacted the Longshoremen’s and Harbor Workers’ Compensation Act of March 4, 1927, which established a workers’ compensation program for “any person engaged in maritime employment.” The 1972 amendments extended the coverage of the Longshore Act but created uncertainty about the boundaries of that extension.

Congress later learned the 1972 law had created “a general confusion as to whether or not the Longshore Act applies.” The rules of coverage became a prolific generator of litigation. In 1984, Congress responded by introducing a degree of clarity: Congress sharpened the Longshore Act’s focus to exclude employees who, although they happened to work on or next to navigable waters, lacked a sufficient nexus to maritime navigation and commerce.

The 1984 statute thus carved out specific employee categories, placed them beyond the coverage of the Longshore Act, and assigned these employees to the “appropriate state compensation laws.” Among the carveouts were employees working for clubs.

Which clubs? All clubs. Initially there was disagreement between the Senate and the House of Representatives about whether the Longshore Act should exclude only employees working at nonprofit clubs. (H.R.Rep. No. 98-570, 1st Sess., p. 4 (1983) (H.R.Rep. 98-570).) The Senate wanted a broader approach but the House initially favored the narrower one. The Senate’s view prevailed: the exclusion applies to all club employees and is not limited to nonprofits.

Ranger concedes that his employer is a “club,” but then asserts that federal law preempts state law in this case.However the Court of Appeal noted that “national and state interests do not clash here. Federal and state law are in accord. For employees like Ranger, both Congress and the California legislature have replaced the fault-based regime of tort with the no-fault alternative of workers’ compensation. Both bodies have preferred the virtues of speedy, predictable, and efficient compensation for occupational accident victims like Ranger.”

Ranger counters this analysis by repeatedly stressing the importance of “uniformity” of the general maritime law. In this quest, Ranger relies on Green v. Vermilion Corp. (5th Cir. 1998) 144 F.3d 332, 334–341.

The Court of Appeal responded “We respectfully but profoundly differ with Green. We therefore also part ways with Freeze v. Lost Isle Partners (2002) 96 Cal.App.4th 45, 51-52 (Freeze), which relied on Green without adding to its analysis.”

Apart from Green and Freeze, Ranger cites cases predating 1984. However, “these authorities deal with old superseded law, not the new governing law.”

“In sum, California’s workers’ compensation law is Ranger’s exclusive remedy. Congress in 1984 decreed this state law aptly covers his situation. A core part of the state workers’ compensation bargain is that injured workers get speedy and predictable relief irrespective of fault. In return, workers are barred from suing their employers in tort. The trial court correctly dismissed Ranger’s tort suit against his employer.”

UC Davis Comprehensive Cancer Center researcher Shehnaz K. Hussain Ph.D., Sc.M. has received a $1.9 million California climate action grant to lead a study into the cancer risks facing firefighters as they battle wildfires.

The grant is funded through a partnership between the University of California and the state of California, which awarded over $80 million in research grants to help put solutions in place that directly address state climate priorities. A total of four UC Davis climate action grants were awarded.

Dr. Hussain’s research, “Exposure Assessment, Health Monitoring, and Cancer Control in Wildland Firefighters” will examine the main carcinogens and cancer risk factors for firefighters as the number of wildfires escalates with climate change.

“California’s firefighters are a climate-vulnerable group due to their heavy burden of occupational exposures related to the increased frequency and scale of wildland fires. The fires are also burning into urban areas where there are many more chemicals and other potential carcinogens that threaten the health of firefighters,” said Hussain, who is also a professor of Public Health Sciences at UC Davis.

Cancer is the leading cause of death among firefighters.

Dr. Hussain said the research will identify areas where equipment, technology, protocols, education, programs, and policy can be developed or amended to reduce exposures to carcinogens, mitigate cancer risks, and improve early detection of cancer in California’s firefighters.

One aim of this research is to capture and test carcinogenic chemicals and other compounds found in wildfire emissions. The team will also study a large group of firefighters to identify biomarkers and occupational and behavioral cancer risk factors that could be reduced in the future. Another objective is to produce stories about California firefighters dealing with cancer. Researchers plan to evaluate the ability of this peer-to-peer storytelling to enhance best practices for cancer prevention in firefighters.

Dr. Hussain will lead a team of biochemical, engineering, microbiology, environmental and occupational scientists on the research initiative. The team will include co-lead Derek Urwin, assistant adjunct professor of chemistry and biochemistry at UCLA and a career firefighter. Other members of the research team include UC Davis colleagues Sheri Belafsky, Cristina Davis, Janine LaSalle, Irva Hertz-Picciotto and Thomas Young.

The California Climate Action Seed Grants and Matching Grants will fund 38 projects that collectively involve more than 130 community, industry, tribal, and public agencies, as well as 12 University of California locations, 11 California State University campuses and two private universities.

Seed grants were awarded to 34 teams totaling $56.2 million. Four teams received matching grants totaling $26.9 million to support larger projects that could leverage additional funding from non-state sources. The $83.l million total is part of $185 million allocated by the state for UC climate initiatives advancing progress toward California’s climate goals.

CapRadio sat down with Dr. Hussain to learn a little more about her plans and how this research might help us better understand the impacts of smoke on Californians as a whole. It’s interview is available online.

The Federal Trade Commission reached a proposed consent order with Amgen Inc. to address the potential competitive harm that would result from Amgen’s $27.8 billion acquisition of Horizon Therapeutics plc. As part of a nationwide settlement of their challenge to the acquisition, the FTC and attorneys general from six states – California, Illinois, Minnesota, New York, Washington, and Wisconsin – also will dismiss the related federal court preliminary injunction action.

The California Attorney General also announced his agreement with this settlement characterizing this as “a groundbreaking settlement with Amgen, one of the world’s largest biopharmaceutical drug companies.” “The lawsuit was the FTC’s first ever challenge of a pharmaceutical merger.”

Under the proposed order, Amgen is prohibited from bundling an Amgen product with either Tepezza or Krystexxa, Horizon’s medications used to treat thyroid eye disease (TED) and chronic refractory gout (CRG), respectively. In addition, Amgen may not condition any product rebate or contract terms related to an Amgen product on the sale or positioning either one of these drugs. Amgen also is barred from using any product rebate or contract term to exclude or disadvantage any product that would compete with Tepezza or Krystexxa.

The proposed consent order resolves FTC and state charges that Amgen’s acquisition of Horizon is anticompetitive, as the deal would enable Amgen to leverage its large portfolio of blockbuster drugs to pressure insurance companies and pharmacy benefit managers into favoring Horizon’s two monopoly products – Tepezza and Krystexxa – or disadvantaging rivals to Tepezza or Krystexxa.

The proposed order also will prohibit Amgen from entering into any agreement or understanding to acquire any products or interest in any business engaged in the manufacturing or sale of any products, biosimilars, or therapeutic equivalents that treat either TED or CRG, unless it receives prior approval from the Commission.

Additionally, Amgen must seek FTC approval if it seeks to acquire any pre-commercial products that have completed FDA clinical trials to treat either thyroid eye disease or chronic refractory gout. Under the terms of the consent order, Amgen is required seek FTC such prior approval through 2032 and notify the states if it is seeking Commission approval.

All other requirements in the consent order will be effective for 15 years after it is finalized, including a requirement that Amgen submit annual compliance reports to the FTC and states. A monitor will be appointed to oversee Amgen’s compliance, and the monitor’s reports will likewise be submitted to the Commission and to the states.

The FTC’s proposed consent order, among other conditions, also requires that Amgen:

– – Submit to the monitor all contracts with payers related to the formulary coverage, placement, or positioning of Krystexxa or Tepezza in the United States within 30 days of entering into such contract.

– – Notify the monitor if either Krystexxa or Tepezza meets all three of the following conditions: 1) Krystexxa or Tepezza has been approved by the FDA for patient self-administration; 2) the self-administered version of Krystexxa or Tepezza is available on the market; and 3) the self-administered version of Krystexxa or Tepezza is otherwise eligible to be covered as a pharmacy benefit product.

– – Require, annually, that all Amgen employees with direct involvement in contracting or negotiations with payers related to the purchase, coverage, placement, or positioning of Krystexxa or Tepezza in the United States to review the consent order acknowledge in writing (including by email) that they understand and are complying with the obligations of the order.

In May 2023, the FTC filed a complaint in the U.S. District Court for the Northern District of Illinois to block the proposed transaction. In addition to alleging that the transaction would give Amgen the ability and incentive to foreclose rivals to Tepezza and Krystexxa, the complaint stated that the deal also would entrench Tepezza’s and Krystexxa’s monopoly positions in the TED and CRG markets, respectively, by substituting Amgen, with its broad and powerful portfolio of blockbuster drugs, for Horizon with its smaller portfolio, thus raising entry barriers and dissuading smaller firms from competing aggressively. This was the FTC’s first litigated challenge to a pharmaceutical merger in more than a decade.

Further details about the proposed order can be found in the analysis to aid public comment.

The Commission vote to accept the proposed consent order for public comment was 3-0, with Chair Lina M. Khan issuing a separate statement, in which she was joined by Commissioner Rebecca Kelly Slaughter and Commissioner Alvaro Bedoya.

The FTC will publish the consent agreement package in the Federal Register shortly. Instructions for filing comments appear in the published notice. Comments must be received 30 days after publication in the Federal Register. Once processed, comments will be posted on Regulations.gov.