Centers for Medicare and Medicaid Services (CMS) Archives - Page 2 of 4

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.

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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.

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.

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CMS expands Medicare coverage to CGMs that integrate with Medtronic insulin pumps

Medtronic (NYSE:MDT) announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) will expand coverage for CGMs.

CMS’ expanded coverage covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs and it notably covers CGMs that integrate with Medtronic insulin pumps.

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.

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…

iRhythm ‘disappointed’ with CMS final rule on wearable ECG patches

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]iRhythm Technologies (NSDQ:IRTC) issued a comment on the CMS Calendar Year 2022 Medicare Physician Fee Schedule (MPFS) Final Rule.

In the Final Rule, CMS (Centers for Medicare and Medicaid Services) did not issue national pricing and continued carrier pricing for the 2022 calendar year on Category I CPT codes 93241, 93243, 93245 and 93247 for extended external ECG (electrocardiograph) monitoring, the relevant codes for the Company’s Zio XT service.

CMS recommended a $200.15 price (the average of the 10 invoices received by CMS) for such wearable ECG patches but did not set that as the reimbursement level for 2022 as the agency awaits more stockholder feedback.

The company and other industry participants have been working with Medicare Administrative Contractors (MACs) to establish pricing for the codes. iRhythm said in a news release that it remains engaged with all parties to submit additional cost data…

Outset Medical achieves landmark Medicare approval for home dialysis system

[Image from Outset Medical]Outset Medical (NSDQ:OM) announced today that it received CMS approval for a payment adjustment on its Tablo hemodialysis system.

San Jose, California-based Outset said in a news release that it received the first-ever CMS approval for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). The decision helps encourage healthcare providers to embrace new technology that allows for patients to dialyze at home, according to Outset.

CMS recently enacted the TPNIES program to increase access to new and innovative medical technologies for end-stage renal disease (ESRD) patients. The add-on payment addresses barriers in the ESRD bundled payment system that can discourage providers from adopting new technologies on themarket.

As part of the TPNIES approval, providers will have access to supplemental reimbursement over the next two years to support patients’ use of Tablo at home.

Tablo…

Massachusetts offers Medicaid coverage for Pear Therapeutics’ digital therapeutics

Pear Therapeutics announced today that MassHealth intends to cover the company’s prescription digital therapeutics (PDTs).

MassHealth, Massachusetts’ Medicaid program, notified Pear of its plans to cover the FDA-authorized reSET and reSET-O PDTs for treating substance use disorder and opioid use disorder, respectively. The decision remains subject to certain customary conditions, including federal and state approvals as well as sufficient funding on both levels.

“We applaud MassHealth for their leadership in introducing PDTs to their Medicaid population to provide safe and effective treatment options for patients in recovery,” Pear Therapeutics president & CEO Dr. Corey McCann said in a news release. “Pear is proud to help fight addiction in Massachusetts, especially at a time when the COVID-19 pandemic is exacerbating the addiction crisis in America with national drug overdose deaths increasing by almost 30% in 2020.”

Boston-based Pear&#…

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.

Medtech gets behind breakthrough device law for seniors

Congressional Democrats and Republicans today introduced a bill to provide Medicare coverage for devices granted FDA breakthrough designation.

Sponsored by U.S. Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cárdenas (D-Calif.), Gus Bilirakis (R-Fla.), Terri Sewell (D-Ala.) and Fred Upton (R-Mich.), the Ensuring Patient Access to Critical Breakthrough Products Act would codify an effort that the Centers for Medicare and Medicaid Services (CMS) has delayed implementing with a final rule.

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