AIHC

NOVEMBER 29, 2023

As more and more potential and real fraud, waste, and abuse was uncovered in the FFS arena, it was also discovered that patient outcomes were less than stellar. We recommend reading Leadership in a Value-Based Care (VBC) Environment in addition to this article. Please note that accuracy of data collection is critical.

Medicare 59

Medicare Medicare Medicaid Medicaid 59

AIHC

NOVEMBER 29, 2023

As more and more potential and real fraud, waste, and abuse was uncovered in the FFS arena, it was also discovered that patient outcomes were less than stellar. We recommend reading Leadership in a Value-Based Care (VBC) Environment in addition to this article. Please note that accuracy of data collection is critical.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” The ASR program was initially open to regulated manufacturers of twelve device categories; Intravascular (I.V.) 312 (2008).

FDA 59

FDA Fraud Governance Compliance 59

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Albrecht , 139 S.

FDA 72

FDA Fraud Governance Medicare 72