On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 23-12, approving a physician-owned hospital’s offer to redeem over a two-year period the...more
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services recently posted Advisory Opinion 22-20, approving an acute care hospital’s arrangement under which its employed nurse practitioners...more
As previous False Claims Act (FCA) Fundamentals posts have discussed, the FCA, 31 U.S.C. § 3729, et seq., can be triggered by submitting claims tied to violations of certain federal statutes. This post will explain the basics...more
Hospitals and Other Providers Should Make Sure Any Items or Services of Value That They Provide to Their Referring Physicians To Alleviate Burnout Comply With the Stark Law - Amidst the ongoing labor market shortages and...more
Report on Medicare Compliance 30, no. 4 (February 1, 2021) - Saint Peter’s University Hospital and New Brunswick Cardiac Cath Lab LLC in New Jersey have agreed to pay $3.04 million to settle a civil monetary penalty case...more
As part of its recent rulemaking process, the Centers for Medicare and Medicaid Services (CMS) finalized a new exception to the Physician Self-Referral Law (the Stark Law) to protect arrangements where limited remuneration is...more
CMS made impactful changes to the Federal physician self-referral law’s (i.e., Stark Law’s) regulations in its Final Rule that were effective January 19, 2021 (with the exception of the changes to 42 C.F.R. § 411.352(i) that...more
The Situation: On November 20, 2020, the Centers for Medicare & Medicaid Services ("CMS") released the long-awaited final rule to modernize and clarify the Stark Law. As part of this final rule, CMS reviewed stakeholder...more
As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations. To recap, our team provided an overview of...more
In November 2020, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) each issued long-awaited final rules that modernize and change the Stark...more
As promised, our team has been studying the two final rules published by the Department of Health & Human Services (HHS) (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services...more
CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...more
The COVID-19 pandemic has led to urgent changes to how and where healthcare services are delivered. These changes could require expedited entry into new or modified arrangements for the delivery of essential healthcare goods...more
The Centers for Medicare & Medicaid Services (CMS) issued Blanket Waivers of certain requirements of the Physician Self-Referral Law (Stark Law). The purpose for the Blanket Waivers is to provide the flexibility providers...more
The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or market value...more
The Centers for Medicare & Medicaid Services and the Office of Inspector General recently released notices of proposed rulemaking relating to the Stark Law and the Anti-Kickback Statute. We break down the new proposed...more
On October 9, 2019, the Centers for Medicare and Medicare Services (CMS) released proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law), including a new proposed exception for limited...more
As part of the long-awaited proposed changes “to modernize and clarify” the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) released on October 9, 2019, the Centers for Medicare and Medicaid...more
On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services Office of Inspector General (HHS-OIG) issued long-awaited proposed changes “to modernize and clarify the...more
Bingham v. HCA, Inc., a recent Eleventh Circuit case, highlights the centrality of fair market value to Anti-Kickback Statute (AKS) analyses. This decision is significant for several reasons and we expect to see Bingham cited...more
On December 17, 2018, the Department of Justice (DOJ) moved to dismiss 11 False Claims Act (FCA) cases brought by whistleblowers against pharmaceutical manufacturers and their commercial outsourcing vendors, alleging that...more
There are many health care financial arrangements where one entity has a financial obligation to another, with whom it either does business directly, or to which it makes referrals, and that obligation is either past due or...more
The Ethics in Patient Referrals Act (“Stark”) prevents hospitals from paying employed or contracted physicians in the same way that physicians are or were paid by independent physician groups. Specifically, physician groups...more
The Centers for Medicare & Medicaid Services (CMS) issued a rare advisory opinion (CMS-AO-2017-1) under the Stark Law (Section 1877 of the Social Security Act, codified at 42 U.S.C. § 1395) earlier this fall, addressing a...more
A clinical laboratory has received a green light from CMS to offer pop-up notifications alerting physicians of various potential issues (Laboratory Alerts) through its web-based portal for ordering and reporting results of...more