Remove category agency-information
article thumbnail

HHS Issues Proposed Rule to Provide Clarity on Rights of Conscience in Healthcare

Healthcare Law Blog

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.

ACA 105
article thumbnail

Medicare Advantage RADV Audit Final Rule Challenged in Court

Healthcare Law Blog

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. The Final Rule therefore violates the APA’s requirement for the Defendants to put forth reasoned agency decision-making.

article thumbnail

FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

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.

FDA 98