EHR Safe Harbor Permanent -
The existing electronic health records items and services Safe Harbor in 42 CFR Section 1001.952(y) was amended by deleting the sunset provision, thereby making the protection permanent....more
On December 2, 2020, the Department of Health and Human Services (HHS), the Office of Inspector General (OIG) and the Center for Medicare and Medicaid Services (CMS) will jointly publish the final regulations first proposed...more
Attached is a PDF issued by CMS regarding blanket waivers of the Stark Law in order to allow physicians and hospitals to adjust 18 different potential financial relationships in order to deal with the COVID-19 emergency. The...more
While we are waiting for final disposition of the AKS Safe Harbors and Stark Exceptions proposed in October of 2019, since the comment period expired December 31, 2019 and final rules have not been issued, I thought we should...more
3/6/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Exceptions ,
Fair Market Value ,
Hospitals ,
Medicare ,
Physicians ,
Proposed Rules ,
Safe Harbors ,
Stark Law
As another part of the Regulatory Sprint to Coordinated Care, OIG proposed revisions to the existing EHR Anti-Kickback Safe Harbor and added a cybersecurity component.
The initial EHR Safe Harbor was developed in response...more
On October 22, 2019, CMS and OIG (Office of Inspector General) released new proposed rules regarding Stark Law Exceptions and Anti-Kickback Safe Harbors in response to what has universally been christened as the “Regulatory...more
11/7/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Exceptions ,
Health Care Providers ,
OIG ,
Physicians ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
HHS has long admitted that the Anti-Kickback Statute (AKS) and the Stark law have not evolved to keep pace with the transition to value based care. In June of 2018, HHS issued an RFI seeking additional information and HHS...more
“Eliminating Kick-Backs and Recovery Act of 2018” (EKRA) is a part of a group of laws recently passed by Congress to expand the law enforcement spectrum available to fight the opioid epidemic. EKRA is part of approximately 70...more
In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. The full text of these proposal and CMS comments and explanations is available below....more
In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. Over the next few days, I will post comment on what I consider the most significant new...more
Cooper v. Pottstown Hospital is another case where a dissatisfied party is attempting to use the federal Anti-Kickback Statute or the Stark Law in litigation arising out of the contracts to which they were willing parties at...more
In OIG Advisory Opinion 14-06, the Office of Inspector General (OIG) concluded that payment by a specialty pharmacy to a retail pharmacy on a “per-fill” basis for services provided by the retail pharmacy could violate the...more
There has been significantly enhanced scrutiny of financial relationships between referring physicians by both the Office of Inspector General (OIG) and Pennsylvania authorities....more
A new OIG Advisory Opinion 13-15, the OIG has resurrected the issue of whether awarding exclusive contracts to hospital based providers involves remuneration in exchange for referrals, because it grants the opportunity for...more