Members of our healthcare industry team have published two LawFlashes that may be of particular interest to hospice clients and friends of Health Law Scan, referring to recent Anti-Kickback Safe Harbor Revisions and the Consolidated Appropriations Act, 2021. Catch up on what you may have missed below.
Recent Anti-Kickback Safe Harbor Revisions: What Hospices Should Know
The US Department of Health and Human Services (HHS) Office of Inspector General’s (OIG’s) recent updates to its Anti-Kickback Statute (AKS) safe harbor rules provide additional legal protections and flexibilities, in particular with regard to value-based enterprise arrangements. While hospices have not been frequent parties to many of the burgeoning risk-based, value-based payment arrangements within the healthcare sector, with the anticipated Medicare Advantage carve-in, this will likely change. Consequently, hospices and their legal counsel are well advised to familiarize themselves with how hospices may benefit from the OIG’s revised AKS safe harbors.
For hospices, the OIG’s December 2020 Final Rule, with new and revised safe harbors effective January 19, 2021, are most significant in four areas: (1) value-based payment arrangements (for care coordination and for those where the parties have substantial downside financial risk or full financial risk); (2) outcomes-based payment arrangements; (3) arrangements for patient engagement and support to improve quality, health outcomes, and efficiency; and (4) part-time personal service arrangements.
Readers may also be interested in our LawFlash, OIG Embraces Broader Anti-Kickback Statute Safe Harbor Protection for Warranties.
Hospice: Consolidated Appropriations Act Revamps Medicare Survey and Certification Process
The Consolidated Appropriations Act, 2021, establishes hospice program Medicare survey requirements and new enforcement procedures under the Medicare program. The hospice provisions are in part a reaction to the 2019 release of a pair of inspection reports detailing the results of hospice surveys by the HHS OIG that attracted negative media attention, but that also garnered a strong response from the hospice industry as many believed the reports lacked balance and focused excessively on the negative findings associated with a small minority of hospices.
Following the OIG reports, legislation was introduced in the 116th Congress to modify the hospice survey process including the Helping our Senior Population in Comfort Environments (HOSPICE) Act, a bill generally supported by the hospice industry. Section 407 of the Consolidated Appropriations Act substantially incorporates the HOSPICE Act and makes important changes to the hospice survey and certification process, including granting Medicare the flexibility to impose financial penalties and alternative remedies for serious violations in lieu of hospice program termination.