Centers for Medicare and Medicaid Services (CMS) Archives

Ekso Bionics earns Medicare win for exoskeleton tech

The Indego Personal exoskeleton. [Image from Ekso Bionics]Ekso Bionics (Nasdaq:EKSO) announced that the Centers for Medicare & Medicaid Services (CMS) proposed a payment level for its exoskeleton.

The Pricing, Data Analysis, and Coding (PDAC) contractor completed its review of the Ekso Indego Personal, approving the use of Healthcare Common Procedure Coding System (HCPCS) Code K1007 to bill Medicare for the device. CMS proposed a payment level of $94,617 for devices under this code. Ekso expects CMS to announce the pricing in February 2024 before the anticipated effective date of April 1, 2024.

Ekso Indego Personal is a modular, lightweight and portable exoskeleton that people can use in most home and community environments. The device features an advanced gait mode for users to reach faster walking speeds, reaching new levels of independence.

This marks the latest reimbursement win for exoskeleton technology. Starting on Jan. 1, 2024, CMS will cover ex…

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…

Myomo prices $4.4M offering, scores reimbursement win

[Image courtesy of Myomo]Myomo (NYSE:MYO) announced today that it priced a “reasonable best efforts” public offering worth proceeds of approximately $4.4 million.

Boston-based Myomo’s offering includes more than 7.3 million shares of common stock priced at 60¢ per share. The company expects to close the offering on or about Aug. 29, 2023, subject to customary conditions.

Myomo develops wearable medical robotic technologies. These offer improved arm and hand function for those suffering from neurological disorders and upper limb paralysis.

The company plans to use proceeds for general corporate purposes, according to a news release. That may include working capital and capital expenditures, R&D expenses and sales and marketing activities.

Earlier this year, the Centers for Medicare and Medicaid Services (CMS) announced a new proposed rule that could benefit Myomo. It would classify the company’s technology as a brace, enabl…

Abbott FreeStyle Libre 3 reader is now available, covered by Medicare

The FreeStyle Libre 3 reader with the sensor and smartphone. [Image courtesy of Abbott]Abbott (NYSE: ABT) + has made its FreeStyle Libre 3 reader available in the U.S., enabling people on Medicare to access the system.

The FreeStyle Libre 3 reader pairs with the company’s latest continuous glucose monitor (CGM) sensor, cleared by the FDA last year. The addressable market for the sensor keeps growing, with massive coverage expansions all around the globe.

A Medicare coverage update kicked in this past spring, expanding access to the sensor. This modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

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

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…

ReWalk Robotics, Myomo to benefit from new proposed Medicare classifications

The MyoPro (left) and Personal Exoskeleton (right) could benefit from a proposed Medicare ruling. [Images from ReWalk Robotics and Myomo]A new proposed rule from the Centers for Medicare and Medicaid Services (CMS) could benefit companies like ReWalk Robotics (Nasdaq:RWLK) and Myomo (NYSE:MYO).

The proposed rule would establish a new regulatory definition of “brace.” In Myomo’s case, it aims to classify the L8701 and L8702 HCPCS codes as “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.

CMS released the proposal on June 30.

How ReWalk Robotics benefits from the proposed Medicare ruling

ReWalk said in a news release that it “applauds” the CMS proposal, which includes personal exoskeletons in the Medicare benefit category for…

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.

New CMS codes for angina detection, tracking benefit Neovasc

The Neovasc Reducer (Image from Neovasc)

Neovasc (Nasdaq:NVCN) announced today the Centers for Medicare and Medicaid Services (CMS) developed favorable new codes.

The new codes cover the diagnosis and tracking of refractory angina. Neovasc develops the Reducer system for reducing angina symptoms in those with refractory angina.

According to a news release, the codes will be utilized in the current, 10th revision of the International Statistical Classification of Diseases and Related Health Problems Clinical Modification (“ICD-10-CM”). The update will be made effective Oct. 1, 2022.

In total, CMS created nine new refractory angina codes. The primary code (I20.2) includes eight supplemental codes describing the condition in combination with various conditions pertaining to atherosclerosis, or hardening of the heart’s arteries.

Neovasc said the codes will help clinicians identify and accurately diagnose patients with refractory angina. Dr. Tim Henry,…

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 — …