Anti-Kickback Statute Medicare

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
News & Analysis as of

Drug Companies and Charitable Patient Foundations

Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more

The Department of Justice Ups the Ante: Per Claim Penalties for False Claims Act and Anti-Kickback Statute Violations Nearly...

On June 30, 2016, the Department of Justice (“DOJ”) published an interim file rule that dramatically increases the per claim penalties for violations of the False Claims Act (“FCA”) and the Anti-Kickback Statute (“AKS”) among...more

The Physician’s Self-Referral Law – Are Changes Finally Coming?

The Physician Self-Referral Law, also known as the Stark law, prohibits a physician from referring federal health care program patients for “designated health services” to an entity in which the physician (or an immediate...more

Check Up on Healthcare Fraud Prosecutions

Chief compliance officers face an overwhelming level of risk in the healthcare sector. I do not mean to belittle the risks of corruption, AML, sanctions and other risks typically associated with global companies. Healthcare...more

Are Changes to the Stark Law on the Way?

Congress has acknowledged that the Stark law is standing in the way of the healthcare industry's transition to alternative, value-based payment models, and in turn, meaningful reform may soon be on the horizon. Last...more

Department of Justice Imposes Almost 100% Increase in Minimum and Maximum Monetary Penalties Under FCA

On June 30, 2016, the U.S. Department of Justice (“DOJ”) announced an interim final rule almost doubling per-claim penalties under the False Claims Act (“FCA”). The FCA still imposes treble damages for government losses in...more

Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty

The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached...more

Senate Finance Committee Examines Repeal of the Stark Law

A new report suggests that the Stark law is obsolete in new payment models. On June 30, the US Senate Committee on Finance (the Committee) released the report Why Stark, Why Now? Suggestions to Improve the Stark Law to...more

OIG Delivers Home Care a One – Two Punch: Release of Report and Alert on Home Health Fraud Highlights Increased OIG Scrutiny of...

On June 22, 2016, the Office of Inspector General (“OIG”) issued two communications that underscore its continued focus on fraud in home health care, along with the role of physicians as “gate keepers” in authorizing...more

Where’s the Crime in Providing Free Medical Care?

Can it be a crime to provide free medical care? That’s the question presented by a post-conviction motion by the so-called King of Nursing Homes, Dr. V. Kuchipudi. Dr. K was convicted on nine counts of violating the...more

Compliance Reminder — DOJ Announces Largest Healthcare Fraud Takedown

On Wednesday, June 22, 2016, the DOJ announced the largest nationwide heath care fraud takedown in history, which resulted in criminal and civil charges against 301 individuals for alleged participation in health care fraud...more

Legal Issues Associated with Multi-Provider Alternative Payment Model

Since the passage of the Affordable Care Act (ACA), both federal and state policies have promoted the adoption of alternative payment models (APMs), providing financial incentives for groups of providers to improve care...more

OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Yet Again, OIG Approves Medigap Policy Contracts with Preferred Hospital Network

On March 11, 2016, the U.S. Department of Health & Human Service, Office of the Inspector General (OIG) issued an advisory opinion approving the use of a preferred hospital network as part of Medicare Supplemental Health...more

AGG Food and Drug Newsletter - March 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

OIG Approves Charitable Program Providing Financial Assistance for MRIs in Advisory Opinion 15-14

On November 13, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-14. The Arrangement at issue is a charitable program designed to assist financially needy...more

OIG Issues (Another) Favorable Advisory Opinion Regarding Medigap/Preferred Hospital Network Arrangement in Advisory Opinion 16-01

On January 7, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 16-01, approving yet another insurer’s proposed contract with a preferred hospital network. The...more

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: December 2015

Trends & Analysis - We have identified 24 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of the 24 cases, five were filed within the past year, seven were filed in 2014, three...more

OIG Policy Statement Outlines Conditions Under Which Hospitals May Waive Beneficiary Copayments for Outpatient Self-Administered...

The OIG has issued a policy statement clarifying the conditions under which hospitals may discount or waive Medicare beneficiary copayment amounts for self-administered drugs (SADs) received in outpatient settings without...more

Limited Modifications in Final ACO Fraud and Abuse Waivers Most Notably Include Cut of Gainsharing CMP Waiver

Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more

CMS and OIG Issue Final ACO Waivers

On Thursday, October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) jointly issued a rule (the “Final Rule”) to finalize five (5) waivers of certain fraud and abuse...more

Millennium Health to Pay $256 million in False Claims Act Settlement

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

OIG Issues Favorable Opinion Giving Green Light To Health System’s Shuttle Service

The Office of Inspector General (OIG) recently issued another advisory opinion on free patient transportation (OIG Adv. Op. No. 15-13, dated October 21, 2015). In the opinion, the OIG addresses whether providing patients a...more

CMS/OIG Finalize Fraud Authority Waivers for Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program...

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized a rule designed to “remove legal and regulatory barriers that can impede care coordination in furtherance of the...more

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