The Senate Finance Committee on Thursday released a bipartisan-supported discussion draft bill that aims to increase mental health access and improve mental health workforce shortages.

The draft bill proposes to fill the gap in mental healthcare worker shortages by funding training for 400 additional Medicare Graduate Medical Education psychiatric slots for residencies per year beginning Oct. 1, 2024. Over a decade, 4,000 psychiatric residencies would be supported by the funding, according to the bill.

The legislation comes as the Biden Administration aims to tackle the country’s worsening mental health crisis. Exacerbated by the COVID-19 pandemic, almost 53 million Americans in 2020 reported being effected by mental illness, according to the HHS. In March, Biden signaled a need for parity in coverage for physical and mental health during his State of the Union speech after the House held a series of hearings outlining the country’s mental health crisis earlier in the year.

This week, the HHS announced a roadmap to incorporate mental healthcare services more broadly into the U.S. healthcare system.

In addition to boosting the mental health workforce, the legislation also proposes to grant Medicare coverage for marriage therapists, family therapists and licensed professional counselors. For the first time, it would also allow licensed clinical social workers to bill Medicare for behavioral assessments and intervention services starting Jan. 1, 2024.

The legislation would increase bonus payments given by Medicare’s Health Professional Shortage Area program to psychiatrists who practice in shortage areas. It also allows non-physician providers, like clinical social workers and psychologists, to receive the shortage bonuses.

Hospitals would also be allowed to give evidence-pased therapeutic programs for their own healthcare workers to address worker burnout under an exception to Stark Law proposed by the legislation. Stark Law prohibits physicians from referring patients for services payable by Medicare or Medicaid to other physicians that they have a financial relationship with.

A federal judge unsealed his opinion on Wednesday in the case that allows UnitedHealth Group to buy Change Healthcare in a $13 billion deal that expands the healthcare giant’s reach in the sector.

Judge Carl Nichols said each step of the DOJ’s arguments had “serious flaws” and that it relied on “speculation” rather than real-world evidence to prove its antitrust claims.

The most serious flaws were failing to prove that UnitedHealth is likely to misuse Change Healthcare’s data to advantage the company, a move that would ultimately chill innovation among rivals, Nichols, a former President Donald Trump appointee, said.

The 58-page document details Nichols’ reasoning behind his Monday order that ruled against the Department of Justice’s bid to block the deal from moving forward over antitrust concerns that it would harm patients and UnitedHealth’s rivals.

Nichols’ opinion was initially placed under seal to protect potentially competitively sensitive information. A redacted version was later made available on the public docket, explaining Nichols rationale for siding with UnitedHealth.

After a thorough trial that lasted more than two weeks, included more than two dozen witnesses and tallied more than 1,000 exhibits, the DOJ failed to prove the transaction is likely to substantially lessen competition, Nichols said in his opinion.

UnitedHealth announced last year that it had inked a deal to buy Change Healthcare, which would provide a key opportunity to leverage insights from billions of healthcare claims, the two said.

Healthcare providers use Change’s technology to submit claims to health insurers, who also use the technology to evaluate and process these claims. The DOJ sued to stop the purchase in February.

The case hinged on how the acquisition would affect two technologies that are vital to processing payments for medical services.

In one of its claims, the DOJ argued UnitedHealth’s purchase of Change Healthcare would create a monopoly of what’s known as first-pass claims editing solutions. The technology allows insurers to process millions of claims per day by applying a payer’s coverage policies or “edits” to a claim, quickly determining whether it should be covered.

Change Healthcare’s technology, ClaimsXten, controls nearly 70% of the market for first-pass claims editing.

The DOJ argued the combination with UnitedHealth would unite the two leaders of the space, giving the pair a 90% market share and eliminate head-to-head competitors.

To alleviate regulatory concerns, UnitedHealth agreed to divest ClaimsXten to a private equity group TPG Capital.

But the DOJ argued that ClaimsXten would be less competitive if purchased by TPG.

Nichols disagreed. The divestiture will maintain and may even improve the firm’s “competitive edge,” Nichols said. A key executive and 375 other people will continue working with ClaimsXten as part of the divestiture, he added.

In its second argument, the DOJ claimed the acquisition would give UnitedHealth access to competitively sensitive data that passes through Change and that UnitedHealth would misuse it by mining rival insurers’ strategies and practices.

But this claim rests on “speculation rather than real-world evidence,” Nichols said. He was swayed by “convincing testimony” from senior UnitedHealth executives who said it would be against the company’s practices — and risk its credibility — to share Optum’s client data to advantage the payer arm of the business, UnitedHealthcare.

The evidence produced at trial shows that “for it to be likely that the proposed acquisition would substantially lessen competition, United would have to uproot its entire business strategy and corporate culture; intentionally violate or repeal longstanding firewall policies; flout existing contractual commitments; and sacrifice significant financial and reputational interests,” Nichols said.

Dive Brief:

• The Food and Drug Administration repeatedly changed its emergency use authorization policies to address the need for COVID-19 testing, allowing problematic tests to be distributed, according to a report released Wednesday by the HHS Office of Inspector General.
• The watchdog found that the FDA made “calculated decisions” to increase test availability, which sometimes came at the expense of accuracy or sufficient validating data.
• The FDA agreed with all the OIG’s recommendations, including expanding the Center for Devices and Radiological Health’s existing device-tracking platform to facilitate FDA submissions, building formal communication channels with the lab community and creating a national testing strategy that goes beyond the EUA process.

Dive Insight:

The OIG focused its review on the early months of the pandemic, between January and May 2020, looking first at the FDA’s authorization of a test developed by the Centers for Disease Control and Prevention. No alternative to the CDC’s test existed when public health labs flagged problems with the test.

The FDA allowed modifications to the CDC’s existing EUA to address some of the problems, such as allowing commercial vendors to manufacture the CDC’s test. The CDC also dropped a component of the test that was failing for most public health labs. 

“Overall, to address the problems with the CDC test rollout, FDA used its EUA authority to an extent that it had not in previous emergency responses,” the report noted. 

“Balancing the need for test availability with test performance amidst an unprecedented pandemic was difficult for FDA to navigate. No roadmap existed to achieve that balance, so FDA made calculated decisions that prioritized testing availability,” the OIG stated in its report. “This meant that poorly performing tests reached the market, although how many were ultimately used or the impact on public health remains unknown.”

Some of the flexibilities also spilled over into commercial tests. For instance, when developers were struggling to find clinical samples to validate tests, the FDA allowed them to use contrived samples, made by “spiking” human specimens with COVID-19 material, but less accurate. The agency also allowed them to use a smaller set of patient samples.  

In late February and early March of 2020, the FDA also rolled out “notification policies,” to let developers begin distributing their tests even before they had obtained an EUA, as long as they notified the FDA and validated the tests first. By May 2020, 245 labs had said they would test under this policy. 

This had the intended effect of making tests available faster, but many tests on the market had performance problems. For instance, of 125 EUA requests for lab-developed tests, 82 had design or validation problems, the FDA found in a later analysis. 

“Weeks or months may have passed before FDA reviewed the EUA request and required a developer to correct performance problems,” the report said. 

A similar notification policy for serology tests resulted by the end of April in more than 150 of those tests being available on the market without an EUA. Some of those tests did not perform as expected, and others falsely claimed to diagnose COVID-19 or have FDA approval, leading to more scrutiny by the agency. 

The report also found that many of the companies were inexperienced. Based on the OIG’s survey of 237 test developers that engaged with the agency, most had not gone through any previous FDA approval or clearance process. 

The watchdog added that the agency has an opportunity to use this experience to better plan for and respond to future public health emergencies.

Dive Brief:

• The Texas Medical Association is suing the HHS over the final rule implementing a federal surprise billing ban, alleging the mechanisms for arbitrating payments unfairly favor insurers.
• It’s the second lawsuit in less than a year that the TMA has filed regarding the No Surprises Act. In February, a judge tossed out part of an interim rule that spelled out the arbitration process, in what was seen as a win for providers.
• The lawsuit, filed Thursday, includes two additional plaintiffs — a physician who owns part of a freestanding emergency room in Tyler, Texas, and Tyler Regional Hospital. The American Hospital Association and American Medical Association said in a statement they plan to file an amicus brief in the case.

Dive Insight:

The NSA, which went into effect in January, aims to protect patients from unexpected and costly medical bills when they unknowingly receive care from an out-of-network provider. Instead of seeking payment from the patient, providers and payers can go through an arbitration process called independent dispute resolution.

The fight between payers and providers over the IDR has been ongoing for years. As the law was being drafted, insurer lobbies pressed for a set rate instead, but providers won out. However, the rules implementing the NSA put forward a more narrow process, and provider groups are pushing back.

An interim rule called for arbiters to primarily consider the qualifying payment amount, which is the median in-network rate in the same geographic area. The TMA and others argue this was not the intent of Congress, as the law calls for taking multiple factors into account, including acuity, market share and provider experience.

The final rule, released in August, dropped the language that the medical group had objected to, but still called for arbiters to consider the QPA first and instructed them to explain their reasoning for including other measures.

“We are, once again, asking for the law to be followed as Congress intended, and for the challenged provisions to be invalidated,” TMA President Gary Floyd said. “There should be a level playing field for physicians and health care providers in payment disputes after they’ve cared for patients.”

This week, the AHA and the AMA asked for a similar lawsuit to be tossed now that the final rule is out.

Violence against physicians in emergency centers is surging, mirroring attacks against healthcare workers in general, according to a poll conducted by the American College of Emergency Physicians.

More than eight in 10 emergency physicians reported that the rate of violence in their workplaces has increased, with 45% noting a spike in incidents in the past five years, ACEP said in a survey published on Thursday. The study included responses from 2,712 physicians collected between July and August of 2022.

Alex Skog, president-elect of ACEP’s Oregon chapter, recounted an incident when “a patient’s family member with a gun holster on his hip threatened to kill me and kill my entire family after I told his father that he needed to be admitted because he had coronavirus,” he said during a call with reporters on Thursday.

“I’ve been scared for my safety as well as the safety of my family,” Skog said. “That was just not something that we were seeing three, four or five years ago.”

Recent attacks on healthcare workers have made headlines, including an incident on Tuesday where an employee at Mission Community Hospital in Los Angeles was approached in the lobby then stabbed multiple times before the assailant fled on foot, according to a press release from the Los Angeles Police Department.

In June, an Oklahoma man who blamed back pain on his surgeon brought an AR-15 rifle and opened fire at his medical office, killing the doctor and three others before taking his own life, according to news reports.

The ACEP poll found that two-thirds of physicians in emergency departments reported being assaulted in the past year alone, while more than a third said they have been assaulted on the job more than once, the survey found.

In addition, almost 70% of respondents said that COVID-19 has decreased the level of trust between patients and physicians or emergency department staff.

Workers in the healthcare and social service industries experience the highest rates of injuries caused by workplace violence and are five times more likely to get injured at work than workers overall, according to data from the Bureau of Labor Statistics. Those incidents have risen nearly every year for healthcare workers since the BLS began tracking them in 2011.

Such violence can range from verbal abuse and threats to physical violence and even homicide and no federal regulations exist directly addressing it.

ACEP and other similar groups recently have renewed their efforts for stronger regulations to protect healthcare workers from violence on the job.

ACEP has said it wants Congress to pass the Workplace Violence Prevention for Health Care and Social Service Workers Act, a Senate companion to a bill that passed the House last April with bipartisan support.

That bill would require hospitals to develop comprehensive workplace violence prevention plans mandated through the Occupational Safety and Health Administration.

ACEP also supports firmer penalties for assailants, along with other groups like the American Hospital Association. The AHA earlier this year called on the Department of Justice to take a tougher stance on violence against healthcare workers by protecting them like airline staff who have also seen more unruly passengers and violent incidents during the pandemic.

Some states also have their own laws penalizing offenders who commit violence against healthcare workers.

A lack of consequences and accountability for assailants “is unfortunately believed to be a significant contributor to the rise of violence since 2018,” Chris Kang, ACEP’s president-elect, said on the call.

COVID-19 testing startup Curative is laying off 109 employees as it pivots its focus from COVID-19 testing to its health insurance plan, according to a Worker Adjustment and Retraining Notification notice.

The company is launching a health plan in the Austin, Texas, area and will offer $0 copays and $0 deductibles after conducting baseline health visits. Curative intends to roll out the plan in additional Texas counties and eventually other states, according to a press release.

The company is making “additional adjustments taking place in staffing throughout the company based on the demand for our COVID-19 testing services and new hiring needs as we launch our new health plan in Texas,” a spokesperson said.

The baseline health visit, which must be completed within 120 days, will assess preventive health needs and aim to improve the health literacy of members.

The plan will be available to employers with 51 or more employees.

“Curative’s new health plan represents its next phase of growth and is the primary focus of the company,” according to the press release.

Health officials have noted since as early as April that COVID-19 testing demand has been decreasing.

Curative was founded in 2020 and provided 35 million COVID-19 tests and 2 million vaccines across more than 40 states during the coronavirus pandemic.