On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a particular item or service is “reasonable and necessary” under section 1862(a)(1)(A) of the Social Security Act (SSA) and sets the stage for commercial insurance coverage to be considered in assessing such coverage in prescribed circumstances. In addition, the final rule establishes a “Medicare Coverage of Innovative Technology” (MCIT) pathway, which is a voluntary and expedited mechanism to obtain national Medicare coverage for medical devices designated with “breakthrough” device status by the Food and Drug Administration (FDA).
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January 13, 2021
On Wednesday, the Centers for Medicare and Medicaid Services (CMS) posted the final rule and amendments to the Code of Federal Regulations regarding the new Medicare Coverage of Innovative Technology (MCIT) pathway. The final rule becomes effective March 15 and establishes an optional pathway that medical device manufacturers and medical facilities can use to seek payment coverage of new and cutting-edge devices more quickly than the current processes allow.
Under the current division of responsibilities, the Food and Drug Administration (FDA) reviews new medical devices for efficacy and safety for use by all patients. These determinations include any restrictions on use, both for safety purposes and intended use. However, a determination from the FDA that a product is safe and effective to use for a person who qualifies for Medicare coverage does not mean that the device automatically is approved for Medicare coverage and payment. Devices ha
Home / Top News / Renalytix Commends HHS/CMS on Finalization of MCIT Rule to Provide National Medicare Coverage for FDA Breakthrough Devices and Diagnostics
Renalytix Commends HHS/CMS on Finalization of MCIT Rule to Provide National Medicare Coverage for FDA Breakthrough Devices and Diagnostics
Creates Pathway for Beneficiary Access to KidneyIntelX for Medicare Beneficiary Kidney Disease Populations
NEW YORK, Jan. 13, 2021 (GLOBE NEWSWIRE) The Centers for Medicaid & Medicare (CMS) announced the establishment of the Medicare Coverage of Innovative Technology (MCIT) pathway (
RIN: 0938-AT88), to provide a coverage pathway for Medicare beneficiaries nationwide to have faster access to new, innovative medical devices and diagnostic tests designated under the Breakthrough Device review program and with market authorization by the U.S. Food and Drug Administration (FDA). Under MCIT, national Medicare coverage can become effective on the date of FDA approval or clearance of a breakthr
About RenalytixAI RenalytixAI (LSE: RENX) (NASDAQ: RNLX) is a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. The Company s lead product is KidneyIntelX.com (visit www.kidneyintelx.com ) which is being designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit www.renalytixai.com Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the potential for KidneyIntelX to receive regula
The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed "breakthrough devices." The new coverage process would enable seniors to get access to these devices more quickly, but some provider and payer groups are concerned that this could cause patient harm.