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Understanding the 2025 Medicare Part D Re-design: What You Need to Know

Innovaare Compliance

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.

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States and Feds Signal Big Changes to Telehealth Prescribing

Health Law Advisor

On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). 2] Statements of Charges may be found on the Washington State Department of Health website, filed under the individual provider’s name and/or license number.

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Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards.

Doctors 52
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Court Denies Motion to Dismiss Based on Implied Preemption

Drug & Device Law

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2010 WL 894054 (N.D.

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