Healthcare Law Blog

SEPTEMBER 28, 2023

The Centers for Medicare & Medicaid Services (“CMS”) released the final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”) on January 30, 2023. This bargain is codified in the statutory mandate of 42 U.S.C. 1395w-23(a)(1)(C)(i) “to ensure actuarial equivalence.”

Medicare 52

Medicare Medicare Overpayments Overpayment 52

Healthcare Law Blog

JANUARY 26, 2023

Medicaid and Medicare The Balanced Budget Act of 1997, Public Law 105–33, 111 Stat. The Medicaid and Medicare statutes also contain conscience provisions related to the performance of advanced directives, religious nonmedical healthcare providers and their patients.

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ACA Medicaid Medicaid Compliance 105

Health Law Advisor

AUGUST 10, 2023

In the last couple of years, each Fall, FDA has been updating a list of machine learning applications in health care that the agency has cleared or otherwise approved. [1] Although that regulation was published in 2011, FDA still uses it as the foundation for determining whether an organization qualifies as an MDDS manufacturer.

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FDA Licensing Hospitals Medicaid 98

Drug & Device Law

NOVEMBER 9, 2023

552 (2011); Thompson v. The FDA’s chief concern about off-label communications from manufacturers has less to do with the safety of such uses − many of which are medical standard of care and Medicare reimbursable − than with the agency’s own bureaucratic imperative. E.g. , Sorrell v. IMS Health Inc. , Caronia , 703 F.3d

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FDA Health Insurance Nurses Medicare 64

Drug & Device Law

JANUARY 30, 2023

280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Bartlett , 570 U.S. Levine , 555 U.S. citation in PLIVA, Inc.

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FDA Fraud Governance Medicare 72