Safe Harbors Anti-Kickback Statute

News & Analysis as of

Don’t Discount the Government’s Recent Statement of Interest in False Claims Act Case

On August 8, 2016, the U.S. government filed a Statement of Interest in an ongoing False Claims Act (FCA)/Anti-Kickback Statute (AKS) case, U.S. ex rel. Herman v. Coloplast Corp., No. 1:11-cv-12131 (D....more

Hospital/Physician Leases Compliance Checklist

LEGAL REQUIREMENTS: A "no" answer to any of the following questions may mean your lease is out of compliance with applicable laws. Is the lease in writing? Is the lease signed by both parties? Does it...more

OIG Issues Favorable Advisory Opinion Regarding Wholly Owned GPO Arrangement

The U.S. Department of Health and Human Services Office of Inspector General (OIG) on May 9, 2016, issued Advisory Opinion 16-06, finding a sufficiently low level of risk in a group purchasing organization (GPO) arrangement...more

OIG Issues Favorable Advisory Opinion Regarding Proposed Ownership Structure of Group Purchasing Organization

On May 2, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) issued a favorable advisory opinion regarding a proposed arrangement, under which a group purchasing organization (GPO)...more

OIG Approves Another Medigap/Preferred Hospital Network in Advisory Opinion 16-04

On April 18th, the OIG issued a new favorable Advisory Opinion, No. 16–04, regarding an agreement between a Medigap insurer and preferred hospital network. The opinion tracked other, similar opinions in favorably addressing...more

Solicitation of New Safe Harbors and Special Fraud Alerts

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently announced its annual solicitation of proposals and recommendations for developing new, and modifying existing, safe harbor provisions...more

HHS OIG Invites Suggestions for New Fraud Alerts, Anti-Kickback Safe Harbors

On December 23, 2015, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published its annual notice soliciting recommendations for new or modified, safe harbor provisions under the...more

OIG Issues Fall 2015 Semiannual Report to Congress

The HHS Office of Inspector General (OIG) has issued its Semiannual Report to Congress covering April 1 – September 30, 2015. The report summarizes significant OIG audits, investigations, and enforcement activities during...more

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

OIG Alert Shows Increased Concern over Data Blocking

In a report to Congress last April, the Office of the National Coordinator for Health Technology addressed the growing issue of data blocking. Data blocking occurs when some person or entity knowingly and unreasonably...more

HHS OIG “Reminder” about Information Blocking & the Federal Anti-Kickback Statute

The HHS Office of Inspector General (OIG) recently released a “Policy Reminder” on how “information blocking” — defined by HHS as knowingly and unreasonably interfering with the exchange or use of electronic health...more

Office Of Inspector General Issues Policy Reminder On Information Blocking And The Federal Anti-Kickback Statue

The federal anti-kickback statute (42 USC § 1320a-7b(b), the “Statute”) prohibits individuals and entities from receiving or soliciting any remuneration for the referral of services reimbursable under any federal health care...more

OIG issues Alert to “remind” providers that information blocking may affect safe harbor protection

On October 6, 2015, the Office of Inspector General (OIG) of the Department of Health and Human Services issued OIG Policy Reminder: Information Blocking and the Federal Anti-Kickback Statute, which “reminds” providers that...more

The “Other” Safe Harbor: OIG Warns Healthcare Providers and Vendors Against Information Blocking and Federal Anti-Kickback...

For those of us who work in the privacy and security space this past week has been a whirlwind with focus on the ramifications of the European Court of Justice (ECJ) decision invalidating the EU-U.S. Safe Harbor Agreement....more

OIG Warns Information Blocking May Affect Safe Harbor Protection

In an alert published October 6, 2015, the OIG reminded the public that “information blocking”—generally described as individuals or entities knowingly and unreasonably interfering with the exchange or use of electronic...more

Giving Your Physician Agreements a Check-Up

On June 9, 2015, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a fraud alert regarding physician compensation relationships and potential liability for illegal kickbacks under the...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Ninth Circuit Finds CFPB Interpretation of RESPA Provision Not Entitled to Deference

On August 24, 2015, the Ninth Circuit found that the CFPB’s interpretation offered in an amicus brief of 12 U.S.C. § 2607(c)(2) of the Real Estate Settlement Procedures Act (RESPA) was not entitled to Chevron deference...more

OIG Approves Lease of Employees to Psych Hospital

On July 28 the Office of Inspector General (OIG) of Health & Human Services gave its blessing to a health system’s lease of employees to a related psychiatric system. Under the arrangement the system would also provide...more

21st Century Cures Act – Provisions Relating to Digital Health: Interoperability and Information Blocking

On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the “bill”) by a vote of 344-77. In addition to increasing medical research funding and expediting the process of making breakthrough...more

Cooperative Hospital Service Organizations: A Hospital Joint Venture Option

Cooperative Hospital Service Organizations (CHSOs) are organizations that are available for hospitals considering certain types of joint ventures with other hospitals. If the terms for their use strictly meet the regulatory...more

Health Law Pulse - January 2015

In This Issue: - Connecticut Supreme Court Rules State Does Not Recognize Mature Minor Doctrine - OIG Issues Advisory Opinion Permitting Copayment Assistance - CMS Announces Recovery Audit Program...more

What You Need To Know About the AKS Proposed Local Transportation Safe Harbor

On October 3, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule to expand the safe harbors and make other modifications applicable to the federal...more

OIG Soliciting New Anti-Kickback Safe Harbor Suggestions

In the December 30, 2014 Federal Register, the OIG solicited comments on potential new or modified safe harbors under the federal Anti-Kickback Statute. Comments are due by March 2, 2015, and the OIG requested that any...more

Blog: HHS OIG Releases Annual Solicitation for New and Modified Anti-Kickback Safe Harbors and for New Special Fraud Alerts

On December 29, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released its annual solicitation (the “Solicitation”) for proposals and recommendations for developing new and modifying...more

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