Innovaare Compliance

JANUARY 15, 2024

2] The current Coverage Gap Discount Program (CGDP), pursuant to the Affordable Care Act 2010 , [3] will be sunset on December 31, 2024. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D.

Medicare 52

Medicare Medicare Compliance FDA 52

Hall Render

AUGUST 10, 2023

New Medical Technologies Beginning in 2025, CMS will require add-on payment applicants to have completed an FDA marketing request and provide documentation of such filing and FDA acceptance of the application by May 1 (rather than the current July 1 deadline) of the year prior to the beginning of the FY in which CMS is considering the application.

Hospitals 40

Hospitals Medicare Medicare Medicaid 40

Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Contact an EBG attorney for more information on how to stay compliant. [1] Utah Code § 58-83-306.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

HIT Consultant

MAY 31, 2023

The pharmaceutical industry has experienced a wave of accelerated consolidation since 2010. Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. million Americans.

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals FDA Telemedicine 96

C&M Health Law

JANUARY 25, 2023

For more information, or to better understand how the Act impacts your organization, please contact the professionals listed below, or your regular Crowell & Moring contact. Section 1001 of the Act delays the 4% Statutory Pay-As-You-Go Act of 2010 (PAYGO) sequester for two years, through the end of calendar year 2024.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

FDA 52

FDA Governance 52