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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…

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.

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

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.

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

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The U.S. Centers for Medicare & Medicaid Services (CMS) rescinded the Medicare Coverage of Innovative Technology (MCIT) and definition of “Reasonable and Necessary” final rule today.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

Get the full story at our sister site, Medical Design & Outsourcing.

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…

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.

Get the full story at our sister site, Medical Design & Outsourcing.

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.

In a Nov. 5 letter, the bipartisan group of lawmakers — U.S. Sens. Michael Bennet, John Barrasso, Marsha Blackburn Bill Cassidy, Maggie Hassan, Mark Kelly, Ben Sasse, Jeanne Shaheen, Kyrsten Sinema and Todd Young — urged CMS Administrator Chiquita Brooks-LaSure to propose a new rule.

“We understand that CMS proposed repealing the existing rule after experts raised concerns about operationalization and patient benefit during the comment process,” the letter read. “CMS should address these concerns and move forward with a pathway for coverage that allows for collection of ap…

How direct-to-patient can impact pharma supply chains

Image courtesy of Pexels

In the wake of COVID-19, telemedicine has become the only means for delivering patient care for many physician groups. As healthcare providers adapted to treating patients virtually, patients likewise adapted to disrupted routines. For those dependent on prescription medication to treat or manage a medical condition, “going to the pharmacy” was an errand replaced by curbside pickup, delivery service or mail order.

Necessity is the mother of adoption

With no other options, the physician-patient interaction went digital after years of discussion about the promise of telehealth. CMS approval of pilot hospital-at-home programs accelerated adoption further. These alternative care sites kept patients free from the risks of hospital-acquired infections and reserved empty beds for possible surges. Program results largely demonstrated that unchanged patient outcomes outside of the hospital se…

CMS aborts launch of MCIT payment program for breakthrough devices

CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.

CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar yesterday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”

Get the full story at our sister site, Medical Design & Outsourcing.

CMS aborts launch of MCIT payment program for breakthrough devices

CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.

CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar on Wednesday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”

CMS created the MCIT pathway in the last days of the Trump Administration, and it was among a host of regulations the Biden Administration immediately put on hold for further consideration.

“While the rule tried to address stakeholder concerns about accelerating coverage of new devices, significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population as well as the benefit or risks of these devices with respect to use in the Medicare population…

Medicare evaluating Aduhelm coverage while Democrats ask Biogen for documents
While CMS is mulling potential coverage of the Alzheimer’s drug, Democrats are seeking information on the approv

As Medicare officials review evidence about Biogen’s (NSDQ:BIIB) Aduhelm (aducanumab) to determine if and how it will cover the drug, two high-level House Democrats are asking Biogen about its dealings with FDA.

Yesterday, Carolyn Maloney (D-N.Y.) and Frank Pallone, Jr. (D-N.J.) sent a letter to Biogen CEO Michel Vounatsos asking for details about the company’s communications with FDA staff before it filed a Biologics License Application for aducanumab. Maloney chairs the House Committee on Oversight and Reform, while Pallone chairs the House Committee on Energy and Commerce.

The House isn’t alone in its push for such information regarding the drug, which could cost patients $56,000 annually in out-of-pocket expense. Acting FDA Commissioner Dr. Janet Woodcock recently asked the Office of Inspector General to launch an independent review of the agency’s dealings with Biogen during the Aduhelm approval process.

Public Citizen recently filed a letter to C…

Senate confirms new CMS leader

The U.S. Senate today confirmed President Joe Biden’s selection to lead CMS, Chiquita Brooks-Lasure, with a 55-44 vote in favor.

Brooks-Lasure will be the first Black woman to hold the position, according to Senate Majority Leader Chuck Schumer (D-N.Y.) on Twitter. She previously served in the U.S. Dept. of Health and Human Services during the Obama administration, during which time she helped to implement the Affordable Care Act, which she will now oversee as the Biden administration seeks to expand it.

Get the full story at our sister site, MassDevice.