Pharmacy Law Blog

MARCH 13, 2018

The federal judge refused the dismissal on the grounds that the government had sufficiently backed its allegations against both the company and its owner. The government had also adequately backed its allegations that RS knew it had been overpaid but had made no attempt to refund the difference to Tricare, according to the judge.

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Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] Medical Device Regulations. Healthcare Laws.

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Verisys

NOVEMBER 14, 2023

A healthcare facility’s accountability and overall reputation are dependent upon rigorous credentialing processes compliant with governing regulatory bodies, such as the National Committee for Quality Assurance. Verisys’ owned and maintained Fraud Abuse Control Information System (FACIS) is a provider data supersource.

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Verisys

JANUARY 18, 2022

A healthcare facility’s accountability and overall reputation are dependent upon rigorous credentialing processes compliant with governing regulatory bodies, such as the National Committee for Quality Assurance. Verisys’ owned and maintained Fraud Abuse Control Information System (FACIS) is a provider data supersource.

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Licensing Medicaid Medicaid Governance 52

Drug & Device Law

MARCH 3, 2022

have dockets heavy on administrative cases and other cases involving the functioning of the federal government and light on product liability cases. 12-cv-734, 2013 WL 1739580 (D.D.C. March 21, 2013). With more than eight years on the federal bench, that is not many decisions. Part of that may be that the D.D.C. Even the D.C.

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Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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Drug & Device Law

NOVEMBER 28, 2022

2013) (Painter); McClellan v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). 2019) (Augustine); In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. II) , 341 F. 3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co. ,

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