Tag: Safe harbor

HHS Releases Long-Awaited Proposed Rules Related to AKS, Stark, CMP Laws for Value-Based and Coordinated Care Arrangements

The U.S. Department of Health and Human Services (HHS) announced today the release of two long-awaited proposed rules to “modernize and clarify” federal laws relevant to value-based and patient coordinated care programs. As previously discussed, these proposed rules are part of HHS’ Regulatory Sprint to Coordinated Care and arise from […]

OIG Seeks Comments to Anti-Kickback Statute and Beneficiary Inducements CMP Related to ‘Patient Centered Care’

The Health and Human Services (HHS) Office of Inspector General (OIG) published today a request for information (RFI) seeking ways in which it might modify or add new safe harbors to the federal Anti-Kickback Statute (AKS) and exceptions to the definition of “remuneration” in the beneficiary inducement provision of the Civil […]

Cooley Alerts | No More Safe Harbor: What Should Life Sciences and Biotech Companies Be Doing to Transfer Data to the US?

Source: Cooley LLP | Media | Alerts | No More Safe Harbor: What Should Life Sciences and Biotech Companies Be Doing to Transfer Data to the US?

OIG Solicits Input for Anti-Kickback Statute Safe Harbor Regulations and Special Fraud Alerts

The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Federal Register notice last week soliciting proposals and recommendations for developing new and/or modifying existing safe harbor provisions for the federal Anti-Kickback Statute (AKS) in accordance with section 14 of the Medicare and Medicaid Patient and Program Protection […]