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.

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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CMS repealed the Medicare Coverage of Innovative Technology (MCIT) program last year but promised to explore other options to improve the coverage process for access to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…

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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…

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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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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 …

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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…

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CMS will limit coverage of Aduhelm to people in clinical trials

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab).

Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval and, about a week later, nonprofit watchdog group Public Citizen called for high-profile resignations for FDA officials as a result of the approval.

In August 2021, the HHS Office of Inspector General announced that it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug.

Yesterday’s CMS policy stated that Aduhelm and any future monoclonal antibodies directed against amyloid approved by the FDA will be covered by Medicare under coverage with evidence development (CED). CMS will, as part of the decision, provide enhanced acces…

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Medtronic announces recent reimbursement wins for CGMs in a number of geographies

The Medtronic MiniMed 780G system. [Image from Medtronic]Medtronic (NYSE:MDT) announced today that reimbursement for its CGMs has been expanded or initiated across a number of countries.

Earlier this month, the Ontario, Canada provincial government announced a comprehensive reimbursement program for continuous glucose monitoring (CGM) for eligible residents who have type 1 diabetes, adding to a similar program for those with type 1 diabetes under 18 years old in Alberta, Canada.

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Pear Therapeutics advances in efforts to get CMS to cover prescription digital therapeutics

Pear Therapeutics (NSDQ:PEAR) announced that the Centers for Medicare & Medicaid Services (CMS) established new coding relevant to its prescription digital therapeutics (PDTs).

CMS established a new Level II Healthcare Common Procedure Coding System (HCPCS) code to describe prescription digital behavioral therapy — FDA-cleared — per course of treatment, which extends to PDTs including Pear’s reSET, reSET-O and Somryst.

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CMS puts final nail in MCIT payment proposal for breakthrough devices

The U.S. Centers for Medicare & Medicaid Services (CMS) rescinded the Medicare Coverage of Innovative Technology (MCIT) and definition of “Reasonable and Necessary” final rule today.

CMS said it intends to explore ways to improve the coverage process for better access to innovative and beneficial medical devices, including a process for the Medicare program to cover new technologies based on scientifically sound clinical evidence and health and safety protections.

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CMS puts final nail in MCIT payment proposal for breakthrough devices

The U.S. Centers for Medicare & Medicaid Services (CMS) rescinded the Medicare Coverage of Innovative Technology (MCIT) and definition of “Reasonable and Necessary” final rule today.

CMS said it intends to explore ways to improve the coverage process for better access to innovative and beneficial medical devices, including a process for the Medicare program to cover new technologies based on scientifically sound clinical evidence and health and safety protections.

“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” CMS Administrator Chiquita Brooks-LaSure said in a news release. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”

The rule would have authorized government payments for medical devices designated as breakthroughs…

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Senators urge CMS to create payment program for breakthrough devices

Ten U.S. senators are calling on the U.S. Centers for Medicare & Medicaid Services (CMS) to create a new rule allowing government payments for medical devices designated as breakthroughs by the FDA.

CMS said in September that it would not move forward with the Medicare Coverage for Innovative Technologies (MCIT) rule, citing safety concerns for Medicare patients.

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