Health Law Advisor
AUGUST 10, 2023
But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.
Bill of Health
MARCH 28, 2023
government has a “paid-up license to practice or have practiced for or on behalf of the United States” the invention “throughout the world” ( 35 U.S.C. 202(c)(4) ), and separately, the right to force the licensing of the invention to one or more third parties, for any use, if the funding agency finds the action necessary.
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HIT Consultant
NOVEMBER 24, 2022
First, let’s examine the new regulatory framework the FDA established. – Prescription hearing aids will require a consumer to have a prescription for a hearing aid from a physician, audiologist or a licensed hearing instrument specialist. These OTC hearing aids do not require a prescription. . million U.S.
Innovaare Compliance
JANUARY 15, 2024
The Prescription Drug Program, commonly known as Medicare Part D, is undergoing significant transformations in 2025 due to the Inflation Reduction Act (IRA) of 2022. Medicare Part D will have three (3) phases instead of four (4) – Deductible, Initial Coverage Phase and Catastrophic Phase. generics) in the catastrophic phase.
Innovaare Compliance
OCTOBER 6, 2022
Annual Election Period (AEP) is about two weeks away when Medicare Advantage Prescription Drug Plans (MAPD) will be signing up new enrollees by the thousands. According to the Centers for Medicare & Medicaid Services (CMS), enrollment in MAPD keeps rising. In 2022, 48% of all eligible Medicare beneficiaries are enrolled in MAPD.
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).
Verisys
NOVEMBER 30, 2022
organizations that receive any funds from Medicare, Medicaid, TRICARE, or other federal programs cannot afford to employ individuals or entities excluded from even one program. License Verification & Monitoring. OIG, SAM DEA, GSA, FDA. Medicare opt out. Medicare and Medicaid Opt-Outs. Credentialing.
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