CMS Archives - Medical Design Sourcing

CVRx scores Medicare win on outpatient Barostim payments

Barostim Neo [Image courtesy of CVRx]CVRx (Nasdaq:CVRX) announced today that the Centers for Medicare and Medicaid Services (CMS) reassigned its Barostim implant procedure.

The CMS change assigns the CVRx neuromodulation implant for procedures performed in the outpatient setting. It comes as part of the 2024 Medicare Hospital Outpatient Prospective Payment System (OPPS) final rule.

Barostim’s reassignment brings it to New Technology APC 1580, which carries an average payment amount of $45,000. The new payment takes effect on Jan. 1, 2024, the Minneapolis-based company said in a news release. This change comes after Barostim was assigned to APC5465 last year — carrying an average payment of $29,000. The change comes with a transitional pass-through payment set to expire on Dec. 31, 2023.

“We sincerely appreciate the consideration taken by CMS of the resource requirements associated with the Barostim implant procedure. We believe that reassignment to AP…

ReWalk Robotics announces solidified Medicare coverage for personal exoskeleton

ReWalk Robotics (Nasdaq:RWLK) announced that the Centers for Medicare & Medicaid Services (CMS) finalized a rule benefitting its exoskeleton technology.

Earlier this year, CMS released a proposal aiming to establish new regulatory definition of “brace.” Adding the definition of brace would expedite coverage and payment for newer technology and powered devices, according to CMS. This potentially enables faster access to the newer technologies, like those made by ReWalk and Myomo as well.

CMS released the proposal on June 30. ReWalk applauded it as it includes personal exoskeletons in the Medicare benefit category for braces. Benefits would extend to the ReWalk Personal Exoskeleton platform, which allows paralyzed patients to stand and walk.

Now, CMS has finalized the Calendar Year 2024 Home Health Prospective Payment System Rule CMS-1780 (“2024 Home Health Rule”) which solidifies the inclusion of exoskeletons in the Medicare brace benefit category. Th…

Medicare now covers new Medtronic MiniMed 780G automated insulin pump

The MiniMed 780G with Guardian 4 and a 7-day infusion set. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that Medicare now covers its new MiniMed 780G system with the Guardian 4 sensor.

Coverage for the recently FDA-approved automated insulin delivery system extends to all eligible Medicare and Medicare Advantage beneficiaries. Medtronic intends to begin processing orders immediately. The company plans to start shipments to eligible recipients with type 1 diabetes over the next few weeks.

MiniMed 780G features SmartGuard technology to eliminate the need for fingersticks. Its Meal Detection Technology provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs. Que Dallara, Medtronic Diabetes EVP and president, told Drug Delivery Business News that this feature is “a big deal.”

Medtronic also presented strong data supporting Meal Time Techno…

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…

Expanded Medicare coverage for CGM to go into effect next month

Left, the Dexcom G7. Right, the Abbott FreeStyle Libre 2. Both expect to benefit from the latest Medicare win. [Images from Dexcom and Abbott]The Centers for Medicare & Medicaid Services today published a final local coverage determination (LCD) expanding coverage for CGMs.

New, expanded coverage of continuous glucose monitors (CGMs) under Medicare go into effect in April.

CMS first published the LCD modifying coverage criteria for CGMs in October. The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia. The proposal eliminates the requirement for frequent adjustments of the patient’s insulin treatment regimen. This falls on the basis of glucose measurement testing.

The finalized version changed some language on the criteria. It amended the line saying “the beneficiary is insulin-treated with at least one daily administration of insulin” to, simply, “the beneficiary is …

Medicare to cover Dexcom G7 when it launches this week

[Image from Dexcom]Dexcom (Nasdaq:DXCM) announced today that Medicare offers coverage for its beneficiaries using the next-generation G7 CGM.

The company announced the coming U.S. launch for G7 in a Super Bowl Commercial with musician Nick Jonas last night. It’s slated to roll out on Friday, Feb. 17.

San Diego-based Dexcom met the category requirements for therapeutic continuous glucose monitor (CGM) systems set forth by CMS. This makes G7 accessible to all Medicare patients with diabetes who meet the eligibility criteria upon the Feb. 17 launch.

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

Analysts: Abbott, Dexcom to benefit from proposed CMS decision on CGMs

Left, the Dexcom G7. Right, the Abbott FreeStyle Libre 2. [Images from Dexcom and Abbott]Analysts see a new proposed local coverage determination (LCD) from CMS as a potential boost for Dexcom (Nasdaq:DXCM) and Abbott (NYSE:ABT).

The Centers for Medicare and Medicaid Services (CMS) yesterday published the LCD modifying coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Abbott and Dexcom both develop market-leading CGMs. The Dexcom G7 recently launched outside the U.S. and the company hopes for FDA clearance early next year. Meanwhile, Abbott recently announced positive data backing its FreeStyle Libre 2 system.

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

AdvaMed pushes CMS for proposed TCET pathway rule this year

The Advanced Medical Technology Association (AdvaMed) is asking the Centers for Medicare & Medicaid Services (CMS) to move fast on a new way to guarantee reimbursement for new medtech innovations.

CMS repealed the Medicare Coverage of Innovative Technology (MCIT) program last year but promised to explore other options to improve the coverage process for access to innovative and beneficial medical devices.

Now, a pathway called the Transitional Coverage for Emerging Technologies (TCET) program could take its place. CMS and medtech industry representatives have discussed the need for Medicare coverage reforms in two listening sessions (transcripts with webinar replay information are here and here).

In an Aug. 1 letter to CMS Administrator Chiquita Brooks-LaSure and Principal Deputy Administrator and COO Jon Blum, AdvaMed called on them to issue a proposed rule this year.

“We believe that CMS, in order to advance its health equity and other…

Proposed 2023 Medicare Physician Fee Schedule could have a big impact on glaucoma surgeries

[Photo by Tobias Dahlberg]

The Centers for Medicare & Medicaid Services has released its proposed Medicare Physician Fee Schedule and issued a call for feedback on the proposed rule, which would take effect Jan. 1, 2023.

Medtech analyst Ryan Zimmerman and the team at BTIG went through the 2,000-page document and identified potentially market-moving changes in two areas: surgical glaucoma and advanced wound care.

CMS proposed cuts for most surgical glaucoma procedure payment rates to physicians, with double-digit losses for tube shunt revision (down 25% from $1,032 to $774), canaloplasty (down 19.9% from $761 to $610) and canaloplasty with a stent (down 11.4% from $799 to $708), according to BTIG research.

The canalplasty rate reduction would likely hit Omni surgical system developer Sight Sciences, Zimmerman said in a BTIG report. It could also give a lift to Alcon and Glaukos, which could see…

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…

Biogen gives up seeking European approval for aducanumab

After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks.

Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021.

At that time, Biogen announced that it would fight the decision.

In April, the company notified EMA that its decision to withdraw its application was “based on interactions with the CHMP [Committee for Medicinal Products for Human Use] indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of Aduhelm (aducanumab).”

“We are thankful to the patients, caregivers and physicians that supported the re-examination process as part of the EMA review,” said Dr. Priya Singhal, head of global safety and regulatory sciences …

Alzheimer’s group files FOIA request related to CMS decision on amyloid-targeting antibodies

UsAgainstAlzheimer’s, a nonprofit organization committed to stopping Alzheimer’s disease, is hoping to get more information related to CMS’s national coverage determination related to coverage for Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and other monoclonal antibodies targeting amyloid to treat Alzheimer’s disease.

The organization has filed a Freedom of Information Act (FOIA) request for information about the decision.

UsAgainstAlzheimer’s is seeking information describing the potentially harmful impact of refusing to cover such monoclonal antibodies outside of clinical trials.

CMS announced their national coverage determination for Aduhelm and other similar future monoclonal antibodies last week.

UsAgainstAlzheimer’s concluded that CMS has denied access to millions of people in the U.S. living with Alzheimer’s.

“The National Coverage Determination is historic – and not in a good way. CMS has covered every FDA-approved drug, but now…