Category: Daily News

The Department of Veterans Affairs said Wednesday it may resume agency-wide adoption of its new electronic health records system next summer, after it was placed on hold in April due to problems involving patient health and safety and frustration among users.

VA officials told members of Congress that introduction of the Oracle Cerner system across 166 additional hospitals could resume in 2024 if the department makes progress on several goals, including a successful rollout in March at the Captain James A. Lovell Federal Health Care Center in Illinois.

The House Veterans Affairs Committee and a House Appropriations subcommittee scheduled hearings this week to receive updates on what originally was supposed to be a $10 billion Oracle Cerner Millennium records system, now used at just five VA sites in the Pacific Northwest and Ohio.

The department is aiming to build a system that is user-friendly to staff members and veterans, has no negative impact on operations, and performs 100% of the time, Dr. Neil Evans, acting program executive director at the VA Electronic Health Record Modernization Integration Office, told members of the House Appropriations Military Construction, Veterans Affairs and Related Agencies subcommittee.

“The path to restarting is to sustain a positive trajectory. We do not need to get to perfection,” Evans said. “On those metrics to exit the reset, we need to see a positive trend improvement in productivity, improvement in user adoption and satisfaction, and improvement in the right direction with regards to technical reliability, which by the way, we’re already starting to see.”

The system was first introduced in October 2020 at the Mann-Grandstaff VA Medical Center in Spokane, Washington, and its affiliated clinics. Almost immediately, it drew criticism from medical providers for its complexity, but also led to delays in care and safety risks for patients.

Its use was expanded to the VA Walla Walla Health Care System in Washington, as well as medical centers in Columbus, Ohio, and Oregon in 2022.

In November 2022, lawmakers raised concerns that two veterans may have died as a result of the system’s complexities — one who never received a needed medication because of issues with prescription tracking in the system and another who missed a medical appointment but received no follow-up because the system didn’t properly record the skipped appointment.

Following reviews by the Government Accountability Office and the VA inspector general that found hundreds of issues with the system, VA leadership decided to halt further deployment until the problems were resolved.

The VA is working with Oracle Cerner, which also provides the electronic health records system MHS Genesis to the Defense Department, to improve operations at the sites where it is being used and to streamline the system to make it more user-friendly and not as complicated to learn.

Among the problems that must be addressed before the system goes live elsewhere, according to VA and Oracle leaders, is “change management” — alleviating the system’s frustration and complexity among users who have spent careers utilizing the VA’s current electronic medical record system, Vista.

“They can almost do [Vista] in their sleep,” Evans said. “Moving to a different system is a change, a significant change, and that change management, I think, has been one of the larger challenges.”

Nonetheless, the system is being tweaked, including 270 changes to make it easier to use, according to officials.

“The feedback around the training, the metrics, were unacceptable and frankly embarrassing,” Oracle Global Industries Executive Vice President Mike Sicilia said during the hearing. “You don’t have to learn to use many IT systems these days. It should be fairly intuitive. That said, there are specialty workflows … that do require some training, but I think you’ll see us move to a just-in-time or iterative model rather than an extended, elongated training.”

VA officials said that with a joint system that allows VA and DoD providers to view both departments’ medical records, along with roughly 90% of records at civilian hospitals, veterans are getting the benefits of a comprehensive electronic medical records program.

But lawmakers remain frustrated over the cost, which included a $1.86 billion request in the fiscal 2024 budget. “This is dangerous on two fronts: People are dying, and it’s costing taxpayers money. Not a little bit of money, a lot of money,” said Rep. Tony Gonzales, R-Texas, a retired Navy master chief petty officer.

Evans said the VA is committed to the program and will make it work. “The department is committed to moving forward as part of the federal electronic health record, in partnership with the Department of Defense. … There is value in doing this together,” Evans said.

“I sure hope so,” said Subcommittee Chairman Rep. John Carter, R-Texas. “We have been in this for a long time.”

The U.S. Department of Labor has just proposed a new rule that would strengthen protections for farm workers in the H-2A program and help prevent abuses that undermine wages and standards for all agricultural workers.

The proposed rule would add new protections for worker self-advocacy, better protect workers against retaliation, make foreign labor recruitment more transparent and enhance the department’s enforcement. This proposal builds on a final rule the department published in October 2022 that modernized key aspects of the H-2A program.

“Farm workers are vital to our farmers, our food supply and our communities,” said Acting Secretary Julie Su. “This proposed rule would strengthen protections for H-2A farm workers who are particularly vulnerable to labor abuses, empower them to advocate for fair treatment and ensure that their employment does not depress labor standards and undercut domestic farm workers. The administration is committed to protecting all workers, and this proposal would significantly advance that effort.”

The proposed rule includes:

– – Adding new protections for worker self-advocacy. The proposed rule would improve workers’ ability to advocate for better working conditions by expanding and clarifying existing anti-retaliation protections. The proposed rule would also expand workers’ rights to invite and accept guests – including labor organizations – to employer-provided housing. Additionally, for workers not protected by the National Labor Relations Act, the proposed rule would require employers to provide a list of workers to a requesting labor organization, permit workers to designate a representative to attend any meeting between a worker and the employer where the worker reasonably believes that the meeting may lead to discipline, and prohibits employers from holding captive audience meetings unless the employer provides certain information to ensure that such meetings are not coercive. The proposal would also create greater transparency for workers about their prospective employers’ stance on their right to organize freely and without interference by requiring employers seeking to hire H-2A workers to provide a certification to the Department of Labor that the employer will bargain in good faith over the terms of a proposed labor neutrality agreement with a requesting labor organization or will explain why they will not do so.
– – Clarifying when a termination is “for cause.” The proposed rule would clarify that an employer only terminates a worker “for cause” when the worker either fails to meet pre-specified productivity standards or fails to comply with employer policies after the employer applies a system of progressive discipline. The proposal would establish six conditions to terminate a worker for cause, including that the employee has been informed of, or reasonably should have known, the employer’s policy, rule or productivity standards. Clarifying the meaning of the term “for cause” in existing regulations is important because termination “for cause” generally strips affected workers of their right to be offered work hours of at least three-quarters of the contract period and right to outbound transportation. For U.S. workers, termination “for cause” also strips them of their right to be contacted for employment in the subsequent year.
– – Making foreign labor recruitment more transparent. In line with concerns expressed by workers’ rights and anti-trafficking organizations, the Government Accountability Office and the department’s Office of Inspector General, the department has found that increased transparency is necessary to help protect agricultural workers from predatory practices during the recruitment process. The proposed rule would require employers to provide a copy of all agreements with any agent or recruiter the employer engages in recruiting prospective H-2A workers to the department, regardless of whether the agent is in the U.S. or abroad. The proposed rule would also require employers to identify and disclose the name and location of anyone soliciting H-2A workers on their behalf.
– – Making wages more predictable. The proposed rule would make wages more predictable in the H-2A program by making new wage rates applicable immediately upon their publication in the Federal Register rather than weeks later. This will ensure that agriculture workers are paid the most up-to-date wages as soon as possible. The rule would also require employers who fail to provide adequate notice to workers of a delay in their start date to pay workers the applicable rate for each day that work is delayed for up to 14 days. The proposal would further require enhanced transparency for employers to communicate minimum productivity standards, applicable wage rates, overtime opportunities and delayed start dates to workers.
– – Improving workers’ access to safe transportation, including seat belts. Workers in the H-2A program often travel long distances to and from the worksite in crowded vans and buses, sometimes driven by workers who worked all day, raising grave concerns about transportation safety. The proposed rule would add a seat belt requirement to reduce these hazards. For vehicles that are required by the Department of Transportation to be manufactured with seat belts, the proposed rule would prohibit the use of any employer-provided vehicle to transport H-2A workers unless each occupant is wearing a seat belt before the vehicle is operated, except in specific circumstances.
– – Enhancing enforcement to improve program integrity. The proposed rule would increase the speed with which the debarment of any business that violates H-2A program rules becomes effective by streamlining deadlines for Office of Foreign Labor Certification integrity and Wage and Hour Division enforcement actions. The proposed rule would also make it easier for the workforce system to discontinue necessary recruitment services for employers who have failed to meet program requirements. Finally, the proposed rule would prohibit employers from holding or confiscating a worker’s passport, visa, or other immigration or government identification documents.

Upon publication in the Federal Register, the notice of proposed rulemaking will be open for public comment for 60 days. The department has provided information on sending comments, and will consider all comments received before publishing a final rule.

The Local Initiative Health Authority for Los Angeles County (L.A. Care) is a public agency that provides health insurance for low-income individuals in Los Angeles County through four health coverage programs including Medi-Cal.

Back in March 2022 LA Care was fined $55 million by the California Department of Managed Health Care and the California Department of Health Care Services for “deep-rooted, systemic failures that threaten the health and safety of its members.” The departments said their investigations were triggered by a September 2020 Los Angeles Times article that identified multiple county residents who died of their conditions following extensive delays for treatment.

And now – slightly more that one year later – the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) just announced a settlement of potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Rules with L.A. Care, the nation’s largest publicly operated health plan that provides health care benefits and coverage through state, federal, and commercial programs.

OCR enforces the HIPAA Privacy, Security, and Breach Notification Rules that set the requirements that HIPAA-regulated entities must follow to protect the privacy and security of protected health information (PHI)

The settlement concludes two OCR investigations initiated from a large breach report and a media article regarding a separate security incident.  Under the agreement, LA Care agreed to pay $1,300,000 and to implement a corrective action plan, discussed in further detail below, which identifies steps LA Care will take to resolve these potential violations of the HIPAA Security Rule and protect the security of electronic protected health information (ePHI).

“Breaches of protected health information by a HIPAA-regulated entity often reveal systemic, noncompliance with the HIPAA Rules,” said OCR Director Melanie Fontes Rainer.  “HIPAA-regulated entities need to be proactive in ensuring their compliance with the HIPAA Rules, and not wait for OCR to reveal long-standing HIPAA deficiencies.  Entities such as LA Care must protect the health information of its insureds while providing health care for the most vulnerable residents of Los Angeles County through its coverage, which includes Medicaid, Medicare, and Affordable Care Act health plans.”

The potential violations in this case included:

– – Failure to conduct an accurate and thorough risk analysis to determine risks and vulnerabilities to ePHI across the organization,
– – Failure to implement security measures sufficient to reduce risks and vulnerabilities to ePHI to a reasonable and appropriate level,
– – Failure to implement sufficient procedures to regularly review records of information system activity,
– – Failure to perform a periodic technical and nontechnical evaluation in response to environmental or operational changes affecting the security of ePHI, and
– – Failure to implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI.

OCR’s investigation found evidence of potential noncompliance with the HIPAA Privacy and Security Rules across LA Care’s organization, a serious concern given the size of this covered entity. In addition to the monetary settlement, LA Care has agreed to take the following steps under a comprehensive corrective action plan that will be monitored for three years by OCR to ensure compliance with HIPAA:

– – Conduct an accurate and thorough risk analysis to determine risks and vulnerabilities to electronic patient/system data across the organization.
– – Develop and implement a risk management plan to address identified risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI.
– – Develop, implement, and distribute policies and procedures for a risk analysis and risk management plan.
– – Report to HHS when it conducts an evaluation due to an environmental and operational change that affects the security of ePHI in LA Care’s possession or control.
– – Report to HHS within thirty (30) days when workforce members fail to comply with the HIPAA Rules.

The resolution agreement and corrective action plan may be found on the HHS website

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.