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.

Medicare 52

Medicare Medicare Compliance FDA 52

CMS.gov

APRIL 15, 2019

Administrator, Centers for Medicare & Medicaid Services. The SSAs visit and survey every Medicare and Medicaid participating nursing home in the nation at least annually to ensure they are meeting CMS’ health and safety requirements as well as state licensure requirements. Ensuring Safety and Quality in America’s Nursing Homes.

Nursing Homes 51

Nursing Homes Nurses Compliance Medicare 51

Healthcare IT News - Telehealth

MARCH 18, 2022

Companies like Pear Therapeutics, Limbix, Applied VR and Click Therapeutics are treating people with clinically validated and FDA-approved (or pending) digital interventions. Compared with Medicare or other populations, Medicaid patients often have more complex social determinants of health and can cycle in and out of beneficiary status.

Medicaid 198

Medicaid Medicaid COVID-19 Telemedicine 198

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.

FDA 98

FDA Licensing Hospitals Medicaid 98

C&M Health Law

JANUARY 25, 2023

Telehealth Section 4113 of the Act extends certain Medicare telehealth flexibilities that were allowed during the COVID-19 PHE for two years, through 2024. The section ensures that telehealth flexibilities under Medicare are extended for two years, regardless of the status of the PHE.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Hall Render

MARCH 16, 2022

The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. On Tuesday, March 15, 2022, President Biden signed into law the Consolidated Appropriations Act of 2022 ( H.R.

COVID-19 40

COVID-19 Medicare Medicare FDA 40

Drug & Device Law

DECEMBER 29, 2023

2023) (rejecting any express anti-preemption presumption in Medicare case) ( here ); Baker v. Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105