CMS proposes new TCET pathway for Medicare coverage of breakthrough devices

The Centers for Medicare & Medicaid Services (CMS) is proposing the new Transitional Coverage for Emerging Technologies (TCET) pathway for breakthrough devices to secure Medicare coverage.

The voluntary program would expedite Medicare coverage for new medtech innovations, offering an estimated three to five years of transitional coverage. CMS repealed a similar program, Medicare Coverage of Innovative Technology (MCIT), in 2021, citing concerns that it may have covered devices without adequate evidence.

The new TCET proposal “supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population,” CMS said in a statement.

CMS will be taking public comment on the notice for 60 days after publication. The notice is scheduled for publication on June 27, 2023.

CMS is currently seeking public comment on new guidance on evidence…

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Olympus applauds CMS move to expand access to colonoscopies

Olympus says CMS recently took a significant step forward to boost colorectal cancer care in the U.S.

CMS, on Nov. 1, announced that it will eliminate Medicare cost-sharing for a follow-up colonoscopy after an at-home stool test returns a positive result. Defining such colonoscopies as preventative services means that Medicare beneficiaries will no longer have out-of-pocket costs for both tests.

Medicare has also reduced the minimum age for colorectal cancer screening from 50 to 45 years.

“These rule changes represent a significant step toward improving colorectal cancer care and expanding access to preventive screenings,” said Paul Skodny, executive director of Global Health Economics & Market Access at Olympus Corp. of America.

“The American Society for Gastrointestinal Endoscopy (ASGE) considers colonoscopy the gold standard for screening, but the procedure may not be readily available to everyone. That’s why it̵…

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Rewalk Robotics seeks reimbursement wins

Rewalk Robotics (Nasdaq: RWLK) today reported its third-quarter revenues were half what they were a year before, with losses widening.

However, the robotic exoskeletons company is seeking to advance its technology through reimbursement wins in the U.S. and Germany.

Early this month, Rewalk submitted its first case to Medicare Administrative Contractors (MACs) for coverage and reimbursement of the company’s exoskeleton for Medicare beneficiaries. The company announced in September that CMS was giving MACs the discretion to cover the exoskeleton.

In addition, the German Federal Social Court will hold a hearing on Nov. 10 to review whether an exoskeleton medical device should be classified as directly or indirectly compensating for the lost function of individuals with spinal cord injuries or paraplegia.

On top of the efforts to secure more reimbursements for the Rewalk robotic exoskeleton, the company had repurchased $900,000 of its stock as o…

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iRhythm stock up on positive news out of CMS

iRhythm Technologies (Nasdaq:IRTC)  stock soared today on positive reimbursement news out of CMS as the agency makes 2023 fee schedule proposals.

Truist analysts yesterday evening pointed to CMS proposing a national coverage determination (NCD) of $229 for the ZioXT wearable cardiac monitor. When incorporating the geographic physician payment adjustments, the analysts thought the actual payment over time to reach over $280.

“We think investors in recent weeks were even potentially bracing for a rate lower than [around] $230, and thus this rate level should serve as a clearing event,” said Truist analysts David Rescott, Richard Newitter and Samuel Brodovsky.

A final CMS rule for fiscal year 2023 is expected around November, according to the analysts.

IRTC shares up more than 22% to $140.99 apiece in midday trading today. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — …

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How the CMS decision to limit Aduhelm coverage could impact Medicare pricing

Since winning approval for the Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq: BIIB) has faced a punishing string of setbacks. As a result, the company’s share price is currently trading near $200 per share — less than half of its $414.71 peak on June 10, 2021.

In April 2022, the Centers for Medicare & Medicaid Services (CMS) dealt one of the most punishing blows to Aduhelm’s future by limiting coverage for the drug to clinical trial participants.

The CMS decision was “certainly an unusual action from CMS,” said Corey Metzman, chief operating officer and co-founder of Chapter, a data-driven digital Medicare advisor. Typically, CMS grants Medicare coverage to FDA-approved drugs. “What was unique about [Aduhelm] is that it went through the accelerated approval process.”

Another wrinkle is that the drug failed to win the backing of the FDA’s Peripheral and Central Nervous System Drugs A…

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Analysts say high payor coverage, increased CGM adoption bodes well for Abbott, Dexcom

Left: Abbott’s FreeStyle Libre CGM system. Right: Dexcom’s G6 CGM. [Images from Abbott and Dexcom, respectively]Analysts have suggested that companies like Abbott (NYSE:ABT) and Dexcom (Nasdaq:DXCM) may benefit from expected reimbursement progress.

BTIG hosted a conference call with North Shore Medical Center (Salem, Massachusetts) Medical Director Dr. Gary Cohen and Healthcare Analytics, LLC analyst and consultant Dr. Joshua Cohen, with the two experts offering insight into prescriber and patient interest in continuous glucose monitors (CGMs) among type 2 diabetes non-intensive insulin therapy (T2 NIIT) patients.

Get the full story at our sister site, Drug Delivery Business News.

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Japan approves expanded reimbursement coverage for Abbott’s FreeStyle Libre CGM

Abbott’s FreeStyle Libre 14 day continuous glucose monitoring system [Image courtesy of Abbott]Abbott (NYSE:ABT) announced today that it received expanded reimbursement coverage in Japan for the FreeStyle Libre system.

Japan’s Ministry of Health, Labour and Welfare approved the expansion for the continuous glucose monitoring (CGM) system to include all people with diabetes who use insulin at least once per day.

Get the full story at our sister site, Drug Delivery Business News.

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Inspire Medical Systems says reimbursement questions cleared up at CMS

Inspire Medical Systems (NYSE: INSP) says CMS has answered some questions about how it will reimburse its implantable sleep apnea treatment device.

The Golden Valley, Minnesota–based company announced on November 10 that CMS has published updated addendum files for the 2022 ambulatory surgery center payment system.

The update included an assigned device offset percentage and final payment rate for new CPT code 64582 — already approved by the AMA CPT Editorial Panel for closed-loop hypoglossal nerve stimulation.

The updated files reflect the national average ASC reimbursement rate for CPT code 64582 of $24,828.64 — versus an initial proposal to peg it at roughly $17,000. The new rate goes into effect on January 1, 2022.

SVB Leerink Research analysts previously noted on November 2 that a CMS final rule published after market close still showed a roughly $17,000 reimbursement range, though Inspire Medical Systems management pointed out CMS commentary…

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CMS delays shift to new payment model for chronic kidney disease treatments

CMS will now wait until Jan. 1, 2022 to start its Kidney Care Choices model, meant to shift the way the U.S. treats chronic kidney disease.

The new payment model was supposed to start on Jan. 1 of this year, but health providers are still grappling with the COVID-19 pandemic.

The new model could have a major effect on dialysis treatment providers including DaVita Healthcare (NYSE:DVA) and Fresenius Medical Care (NYSE:FMS; ETR:FRE). Baxter (NYSE:BAX) meanwhile announced in 2019 that it was investing in technologies to support the effort.

The new model’s roots go back to former President Donald Trump’s 2019 executive order to emphasize transplants and home hemodialysis over in-clinic treatment. End-stage renal disease is one of the few conditions in the United States where there is already a single-payer system, thanks to a law signed by President Richard Nixon in 1972.

The Kidney Care Choices (KCC) model would provide strong financial i…

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EmblemHealth to provide coverage for Senseonics’ Eversense CGM

Senseonics (NYSE:SENS) announced that EmblemHealth is now providing coverage for its Eversense continuous glucose monitoring system.

Germantown, Md.-based Senseonics said in a news release that the immediately effective decision adds to the number of payers writing the Eversense system into their CGM coverage policies and paying for the healthcare provider’s time for the in-office sensor placement.

EmblemHealth, which operates in New York, New Jersey and Connecticut, expands access to approximately 2.9 million residents across the three states with the addition of Eversense to its 2021 CGM policy.

Eversense features a fluorescence-based upper-arm sensor, a smart transmitter worn over the sensor and a mobile app for displaying glucose values, trends and alerts. The system also includes a smart transmitter that provides discreet on-body vibratory alerts and can be removed, recharged and re-attached without discarding the sensor.

“We are excite…

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The top 5 MassDevice stories of the week — September 4, 2020

Medtronic (NYSE:MDT) and a major development involving medtech reimbursement dominated medical device industry news over the past week.

As the week closes out, there’s also a trending story on MassDevice that includes good news: Abbott (NYSE:ABT) is reportedly hiring 2,000 new employees in Illinois to increase manufacturing for its rapid COVID-19 test.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. FDA approves Medtronic MiniMed 770G insulin pump for young children

The FDA has approved the Medtronic MiniMed 770G  hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years. The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose mon…

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Insightec wins Medicare coverage for incisionless neurosurgery platform

Insightec announced today that it has secured complete Medicare coverage across the U.S. for its MR-guided focused ultrasound treatment of medication-refractory essential tremor.

The coverage comes roughly four years since the Tirat Carmel, Israel–based company won FDA approval for the technology.

Insightec officials said compelling clinical evidence and support from physicians, specialty societies and patients enabled the company to achieve coverage in the final two Medicare jurisdictions. The company has worked closely with the seven Local Medicare Administrative Contractors over the past 18 months.

“Complete Medicare coverage is a significant milestone for Insightec and brings the incisionless treatment option to millions of people,” Dr. Maurice R. Ferré, Insightec’s CEO, said in a news release. “This is the critical next step in our mission to make focused ultrasound a standard of care to improve the lives of people living wit…

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