Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
Approaching Year End- Which holiday do you dread the most? For me, it has always been, and likely will always be, Labor Day. Of course, with each passing year, anything that I describe as “always” is less meaningful than...more
In this post, we summarize noteworthy False Claims Act (FCA) decisions so far from 2023. Each of the three circuit court opinions discussed here ruled in favor of the defendants on different aspects of the FCA: the Sixth...more
On April 27, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-08 (Advisory Opinion) in which it declined to impose sanctions against a federally qualified health center (Requestor) for an arrangement...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
The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more
On July 24, 2020, OIG issued an Advisory Opinion (AO), AO 20-04, regarding whether an arrangement where a charitable organization purchases or receives donations of unpaid medical debt from health care providers, and then...more
On July 1, 2020, OIG published an advisory opinion regarding a discount medical plan organization (DMPO). A DMPO is not an insurer but contracts with providers who agree to reduce their fees for the DMPO’s members. Under...more
On June 26, the Department of Health and Human Services Office of the Inspector General (OIG) issued Advisory Opinion No. 20-03 approving the payment by a discount medical plan organization (DMPO) of a five dollar ($5.00) fee...more
In the midst of the Coronavirus (COVID-19) pandemic, healthcare providers and suppliers will need to make decisions on how to ensure compliance with existing federal fraud and abuse laws while taking swift action to avoid...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 September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more
A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more
A recent Office of Inspector General (OIG) advisory opinion approved a proposal under which a hospital has established a caregiver center that provides or arranges for free or reduced-cost support services to caregivers in...more
In what is becoming a steady trend, the Office of Inspector General (OIG) published another favorable opinion for an arrangement seeking to implement programs that support and engage family members who are increasingly...more
Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In...more
The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more
The U.S. Senate Republicans on July 13, 2017, released an updated discussion draft of the Better Care Reconciliation Act of 2017 (BCRA), its bill to repeal and replace the Affordable Care Act (ACA). As we have outlined in a...more
The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical...more
Holland & Knight originally issued this alert in March 2017 regarding the American Health Care Act (AHCA) as it stood on that date. This client alert provides an update on the AHCA as passed by the U.S. House of...more
A relatively recent case involving buy-in terms in an ambulatory surgery center demonstrates how different valuations for referral sources and non-referral sources can be evidence of remuneration under the Medicare...more
The House Committee on Ways and Means and the House Energy and Commerce Committee released proposed legislation on March 6, 2017, to partially repeal and replace parts of the Affordable Care Act (ACA), which was signed into...more
As of January 6, 2017, final rules published by the United States Department of Health and Human Services Office of the Inspector General (the “OIG”) implementing certain exceptions to the Civil Monetary Penalty law (“CMP”)...more
The Office of Inspector General (“OIG”) of the Department of Health and Human Services has issued a final rule (“Final Rule”) adding new safe harbors to the federal anti-kickback statute, amending existing safe harbors, and...more