The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the first of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding health care...more
6/2/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Government Agencies ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Regulatory Reform ,
Value-Based Care
The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more
The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more
1/29/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Incentives ,
Medicare ,
Organ Transplant Centers ,
Penalties ,
Regulatory Requirements ,
Value-Based Care
The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more
Under the proposed regulation, sponsors and sponsor-investigators whose planned study falls within an exemption will not be required to submit an Investigational New Drug application ("IND") or comply with IND reporting...more
The Situation: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid...more