HIT Consultant
NOVEMBER 24, 2022
First, let’s examine the new regulatory framework the FDA established. Health plans could, for example, consider covering OTC hearing devices as part of the hearing benefits package provided to their Medicare Advantage plan members. Health plans should be on the alert for potential pitfalls arising from the new regulations.
Health Law Advisor
JANUARY 13, 2022
The proposed decision, which is subject to public comments that are due to CMS by February 10, 2022, does not endorse nationwide Medicare coverage for these drugs. After the FDA approval, several large medical centers stated that they would not be administering Aduhelm due to concerns about its efficacy. [1]. What Happens Next?
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Healthcare Law Blog
NOVEMBER 13, 2023
On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The UM committee was established in April 2023 in the 2024 Medicare Advantage and Part D Final Rule (CMS-4201-F).
Health Law Advisor
JULY 21, 2023
On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly anticipated take on a mechanism to expedite coverage for certain devices designated by the U.S. Food and Drug Administration (FDA) as breakthrough devices. [1]
Healthcare IT News - Telehealth
JANUARY 23, 2024
Sean Brady, CEO and cofounder of Ventric Health, is doing his part to turn this problem around. He is head of the team behind a newly FDA-cleared cardiac device designed to help manage the challenges around heart failure. Please describe your newly FDA-cleared cardiac device for heart failure and discuss how it works.
Healthcare Law Blog
MARCH 17, 2022
On Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. 22-05 , relating to subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial involving medical devices (the “Proposed Arrangement”).
Redox
OCTOBER 12, 2023
These enhancements have the potential to not only reduce provider costs, but also prevent errors, advance treatments, and improve health outcomes. AI’s superpower lies in its ability to intelligently mine insights from the exponential amount of health data that is generated every second. Two states have enacted such measures.
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