New Stark and Anti-Kickback Exceptions: Just yesterday, the Department of Health and Human Services issued proposed rules that have yet to be published in the federal registry, that loosen the prohibitions in the Stark Law and Anti-Kickback Statute to include new exceptions centered on value-based arrangements. The OIG drafted the proposed rule regarding the Anti-Kickback Statute and CMS drafted the proposed rule regarding the Stark Law.
On September 27, 2019, the Food and Drug Administration (FDA) released new guidance, replacing the December 2017 guidance, regarding clinical decision support (CDS) software. The new guidance expands the scope of the agency’s control of CDS software developed for providers, patients, and caregivers and clarifies which kind of software no longer is considered to be a medical device under the law.
As technology continues to be a pervasive platform for the healthcare industry in improving patient care, the Office of Inspector General of the Department of Health and Human Services (OIG) posted Advisory Opinion 19-04 which approved a technology company’s proposal to make visible to federal health care program beneficiaries its online healthcare directory for searching and booking medical appointments and sponsored advertisements.
The debate over the methodology to calculate Disproportionate Share Hospital (DSH) reimbursement to hospitals continues. In June, we updated you on Azar v. Allina Health Services when the Supreme Court vacated an HHS policy requiring DSH hospitals to include Medicare Part C enrollees in their Medicare fraction because HHS did so without going through the notice and comment period set by the Medicare Act for a substantive legal change.
In a recent decision by the New York Court of Appeals, which is New York’s highest court, the Court held that payors can withhold amounts paid to a provider if the provider violates the corporate practice of medicine by ceding too much control to a management service organization (MSO). Andrew Carothers, M.D., P.C. v. Progressive Insurance Company, Docket No. APL-2017-00225 (2019).