Paralyzed Man Walks Again Via Thought-Controlled Implants

A paralyzed man has regained the ability to walk smoothly using only his thoughts for the first time, researchers said on Wednesday, thanks to two implants that restored communication between brain and spinal cord.

The patient Gert-Jan, who did not want to reveal his surname, said the breakthrough had given him "a freedom that I did not have" before.

The 40-year-old Dutchman has been paralyzed in his legs for more than a decade after suffering a spinal cord injury during a bicycle accident.

But using a new system he can now walk "naturally", take on difficult terrain and even climb stairs, according to a study published in the journal Nature.

The advance is the result of more than a decade of work by a team of researchers in France and Switzerland.

he advance is the result of more than a decade of work by a team of researchers in France and Switzerland.

Last year the team showed that a spinal cord implant—which sends electrical pulses to stimulate movement in leg muscles—had allowed three paralyzed patients to walk again.

But they needed to press a button to move their legs each time.

Gert-Jan, who also has the spinal implant, said this made it difficult to get into the rhythm of taking a "natural step".

'Digital Bridge'
The latest research combines the spinal implant with new technology called a brain-computer interface, which is implanted above the part of the brain that controls leg movement.

The interface uses algorithms based on artificial intelligence methods to decode brain recordings in real time, the researchers said.

This allows the interface, which was designed by researchers at France's Atomic Energy Commission (CEA), to work out how the patient wants to move their legs at any moment.

The data is transmitted to the spinal cord implant via a portable device that fits in a walker or small backpack, allowing patients to get around without help from others.

The two implants build what the researchers call a "digital bridge" to cross the disconnect between the spinal cord and brain that was created during Gert-Jan's accident.

"Now I can just do what I want—when I decide to make a step the stimulation will kick in as soon as I think about it," Gert-Jan said.

After undergoing invasive surgery twice to implant both devices, it has "been a long journey to get here," he told a press conference in the Swiss city of Lausanne.

But among other changes, he is now able to stand at a bar again with friends while having a beer.

"This simple pleasure represents a significant change in my life," he said in a statement.

'Radically Different'
Gregoire Courtine, a neuroscientist at Switzerland's Ecole Polytechnique Federale de Lausanne and a study co-author, said it was "radically different" from what had been accomplished before.

"Previous patients walked with a lot of effort—now one just needs to think about walking to take a step," he told a press conference in the Swiss city of Lausanne.

There was another positive sign: following six months of training, Gert-Jan recovered some sensory perception and motor skills that he had lost in the accident.

He was even able to walk with crutches when the "digital bridge" was turned off.

Guillaume Charvet, a researcher at France's CEA, told AFP this suggests "that the establishment of a link between the brain and spinal cord would promote a reorganization of the neuronal networks" at the site of the injury.

So when could this technology be available to paralyzed people around the world? Charvet cautioned it will take "many more years of research" to get to that point.

But the team are already preparing a trial to study whether this technology can restore function in arms and hands.

They also hope it could apply to other problems such as paralysis caused by stroke.

More information: Grégoire Courtine, Walking naturally after spinal cord injury using a brain–spine interface, Nature (2023). DOI: 10.1038/s41586-023-06094-5www.nature.com/articles/s41586-023-06094-5

Journal information: Nature 

 

CMS Listens to APTA, Reverses Course, OKs Hospital Use of Telehealth Post-PHE

APTA

Though many questions still remain, the U.S. Centers for Medicare & Medicaid Services has offered one answer on the use of telehealth in facility settings now that the public health emergency has ended: For hospital-based facilities, it's a go. The announcement is a major reversal from CMS' earlier position against use of telehealth in that setting.

The clarification, provided late Friday afternoon, can be found in a CMS FAQ document available online (see question 21). Essentially, the agency responded to advocacy by APTA and other organizations and now says that hospitals can bill Medicare for services provided via telehealth until the end of 2023. Previously, CMS had suggested any setting that used a UBO4 claim form — the form used by most hospitals — was excluded from billing for telehealth after the end of the public health emergency.

While a welcome development, the reversal only addresses a portion of the settings in which the fate of telehealth remains unresolved: CMS has yet to address similar questions about skilled nursing facilities, home health agencies, and rehab agencies. APTA met with representatives from the U.S. Department of Health and Human Services last week to press for resolution, who indicated that not all guidance may be produced quickly.

APTA continues to monitor the issue and will provide updates as available. The association's call for a resolution to the problem has been reinforced through a statement signed by coalition of organizations.

 

Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) Staff Vaccination Requirements

On November 5, 2021, the U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (CMS-3415-IFC) requiring Medicare and Medicaid-certified providers and suppliers to ensure that their staff were fully vaccinated for COVID-19 (i.e., obtain the primary vaccination series), which was a critical step to protect patients. On April 10, 2023, the President signed legislation that ended the COVID-19 national emergency. On May 11, 2023, the COVID-19 public health emergency is expected to expire. In light of these developments and comments received on the interim final rule, CMS will soon end the requirement that covered providers and suppliers establish policies and procedures for staff vaccination. CMS will share more details regarding ending this requirement at the anticipated end of the public health emergency. We continue to remind everyone that the strongest protection from COVID-19 is the vaccine. Therefore, CMS urges everyone to stay up to date with your COVID-19 vaccine.

Emergency Preparedness: Training and Testing Program Exemption

The following information supersedes the previously issued QSO-20-41-ALL-REVISED memo for all certified providers/suppliers. CMS regulations for Emergency Preparedness (EP) require the provider/supplier to conduct exercises to test their EP plan to ensure that it works and that staff are trained appropriately about their roles and the provider/supplier’s processes. During or after an actual emergency, the EP regulations allow for a one-year exemption from the requirement that the provider/supplier perform testing exercises. The exemption only applies to the next required full-scale exercise (not the exercise of choice), based on the 12-month exercise cycle. The cycle is determined by the provider/supplier (e.g., calendar, fiscal or another 12- month timeframe). The exemption only applies when a provider/supplier activates its emergency preparedness program for an emergency event.

 

Updates to Coverage for COVID-19 Tests

The COVID-19 Public Health Emergency is to end on May 11, 2023. The ending of the Public Health Emergency may impact an individual’s coverage of COVID-19 tests. We encourage you to know these changes and share the New Consumer Fact Sheet on COVID-19 tests.

Consumer Fact Sheets:

Before May 11, 2023

If you have any type of health insurance, you can get up to eight over-the-counter tests per month with no out-of-pocket costs. Over-the-counter tests are available in most pharmacies and may also be available online for delivery.

After May 11, 2023

Laboratory tests for COVID-19 that are ordered by your provider will still be covered with no out-of-pocket costs for people with Medicare. Over-the-counter tests will still be available, but there may be out-of-pocket costs. Coverage of over-the-counter tests may vary by your insurance type, as described below.

What does this mean for Medicare Beneficiaries?

Generally, Medicare doesn’t cover or pay for over-the counter products. The demonstration that has allowed us to offer coverage for COVID-19 over-the-counter tests at no cost ends on May 11, 2023.

However, if you are enrolled in Medicare Part B, you will continue to have coverage with no out-of-pocket costs for appropriate laboratory-based COVID-19 PCR and antigen tests, when a provider orders them (such as drive-through PCR and antigen testing or testing in a provider’s office).

If you are enrolled in a Medicare Advantage plan, you may have more access to tests depending on your benefits. Check with your plan.

What does this mean for people with Medicaid or Children’s Health Insurance Program?

If you have coverage through Medicaid or the Children’s Health Insurance Program, you will have access to COVID-19 over-the-counter and laboratory testing through September 30, 2024. After that date, coverage of testing may vary by state.

What does this mean for people with Private Insurance?

If you have private insurance, coverage will vary depending on your health plan. However, private plans won’t be required by federal law to cover over-the counter and laboratory-based COVID-19 tests after May 11, 2023.

If your insurance chooses to cover COVID-19 testing, they may require cost sharing, prior authorization, or other forms of medical management.

 

Medicare Advantage Enrollment Officially Crosses 50% of Beneficiaries: KFF

Fierce Healthcare | By Paige Minemyer
 
It's official: Medicare Advantage (MA) enrollment accounts for just over half of all Medicare beneficiaries, according to a new analysis from the Kaiser Family Foundation.
 
KFF researchers analyzed data from the Centers for Medicare & Medicaid Services and found that 30.19 million of the 59.82 million people enrolled in Medicare as of January 2023 were in an MA plan, the first time the program has crossed 50% of all Medicare enrollment.
 
Medicare Advantage has grown at a steady clip since its inception. Enrollment in private Medicare plans accounted for just 19% of the program in 2007, according to KFF. By 2019, enrollment had doubled to 39%.
 
"Enrollment in Medicare Advantage has increased dramatically in recent years," the KFF analysts wrote. "The growth in enrollment is due to a number of factors, including the attraction of extra benefits offered by most plans, such as vision, hearing, and dental services, and the potential for lower out-of-pocket spending, particularly compared to traditional Medicare without supplemental coverage."
 
In addition, MA coverage is attractive to many as it provides a one-stop shop for beneficiaries, since they will not need to shop separately for Part D coverage or supplemental plans, the researchers added.
 
The rapid growth has made MA a central focus for insurers, who generate significant profit in this space. Enrollment nationally is dominated by UnitedHealthcare and Humana.
 
That expansion has also led to far greater scrutiny on how insurers are managing the program along with concern that they're pocketing excessive dollars as MA grows. There is also a dearth of data on how MA compares to traditional Medicare in managing equity challenges and reaching underserved patient populations, the KFF researchers said.
 
Critics are also concerned about utilization management in the program, and the KFF report said that in 2021 alone MA members submitted 35 million requests for prior authorization.
 
"As the role of Medicare Advantage grows, so will interest in understanding how well the program serves the increasingly diverse group of enrollees who receive their Medicare coverage from private insurers," the KFF researchers said.

 
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