Medmarc Blog (blog.medmarc.com)
Centers for Medicare & Medicaid Services (CMS) (2)
CMS Adds Administrator, Hits Pause on MCIT
CMS Adds Administrator, Hits Pause on MCIT The Center for Medicare & Medicaid Services has a new administrator, Chiquita Brooks-LaSure, signaling an end to a leadership void at an agency that is...
CMS Suspends MCIT Start Date
The Centers for Medicare & Medicaid Services has suspended the effective date for the proposed Medicare coverage program for FDA-designated breakthrough devices, temporarily reversing a program...
FDA Releases Action Plan for AI | Medmarc
The FDA announced an action plan for artificial intelligence in mid-January, which comes across largely as a follow-up to a discussion paper the agency posted in April 2019. The plan lays out a...
HHS Announces Delayed HIT Compliance Deadlines
The Department of Health and Human Services has responded to concerns about compliance dates for healthcare IT with an interim final rule that relaxes those deadlines by nearly half a year....
FDA Closes EUA Program to Lab-Developed Tests
The question of whether the FDA has the authority to regulate lab-developed tests (LDTs) boiled into plain view in August when the Department of Health and Human Services directed the agency to...
CMS Floats Coverage Policy for Breakthrough Devices
The Centers for Medicare & Medicaid Services recently unveiled a new plan to offer four years of Medicare coverage for any medical devices cleared or approved through the FDA’s breakthrough...
Churn at Justice as Drug Pricing Rule Falters Again
Bipartisan supporters of drug pricing transparency in the U.S. absorbed another blow when an appeals court rejected the Trump administration’s drug price transparency rule as lacking statutory...
ONC, CMS Delay Compliance Dates for EHR Interoperability
The COVID-19 pandemic has incurred a number of regulatory casualties in recent weeks, and the final rules for electronic health records (EHRs) promulgated earlier this year are two of the...