Remove category
article thumbnail

How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

First, let’s examine the new regulatory framework the FDA established. For the first time, all hearing aids will fall under two categories: prescription hearing aids and OTC hearing aids. Health plans should be on the alert for potential pitfalls arising from the new regulations. Introducing OTC hearing aids. million U.S.

FDA 98
article thumbnail

CMS “Splits the Baby” on Aduhelm—Medicare Coverage but Only with Evidence Development for Now

Health Law Advisor

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?

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

Healthcare Law Blog

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”).

article thumbnail

15 HLTH 2021 Predictions from Digital Health Executives to Watch

HIT Consultant

COVID was a wakeup call: state public health departments were unable to process test results quickly because of lack of a standard way for labs to report test results, slowing the pandemic response. So, high quality, accurate data will be an imperative for member satisfaction. via a mobile app.

article thumbnail

CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

Healthcare Law Blog

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).

article thumbnail

TAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year

Health Law Advisor

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]

FDA 52
article thumbnail

Health Provider News

Hall Render

CALIFORNIA 8 ASCs opening in Florida, California and New York A bankrupt California hospital left a health care desert. CALIFORNIA 8 ASCs opening in Florida, California and New York A bankrupt California hospital left a health care desert.