Advisory Opinions

News & Analysis as of

OIG Advisory Opinion 15-07: An Indicator of Clinical Trial Copayment Change?

“You scratch my back, I scratch yours” arrangements are common in business transactions. These agreements are risky in the healthcare space, however, with the potential to implicate civil and criminal sanctions. Whether...more

OIG Approves Charitable Organization's Patient Assistance Program

On May 28, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a charitable organization’s proposal to provide financial assistance to individuals with...more

OIG Approves Subsidies to Medicare Beneficiaries Provided by a Clinical Research Study

On May 28, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a medical device manufacturer’s proposed arrangement to provide subsidies to certain...more

New York Issues Tax Advisory Opinion Regarding Cloud Computing Product

The new guidance addresses the New York sales and use tax treatment of cloud computing services. Background - On April 14, the New York State Department of Taxation and Finance (the Department) issued Advisory...more

Four Things You Should Know about New York State’s Recent Advisory Opinion on the Taxation of Software as a Service (“SaaS”)

On May 15, 2015, the New York State Department of Taxation and Finance released Advisory Opinion TSB-A-15(2)S which concluded that sales of certain cloud computing services are not subject to New York State sales and use tax....more

Four Things You Should Know About New York's Recent Advisory Opinion on the Taxation of SaaS

On May 15, 2015, the New York Department of Taxation and Finance determined in Advisory Opinion TSB-A-15(2)S that the sale of certain cloud computing services were not subject to New York State sales and use tax. The Advisory...more

OIG Issues Unfavorable Advisory Opinion on Proposal for Exclusive Laboratory Services Arrangements

On March 25, 2015, the U.S. HHS Office of Inspector General (OIG) released an unfavorable Advisory Opinion in which it found that it could potentially impose administrative sanctions and exercise its permissive exclusion...more

CFTC Issues Advisory on Ownership and Control Reporting

The Division of Market Oversight (DMO) and Division of Swap Dealer and Intermediary Oversight (DSIO) of the Commodity Futures Trading Commission have issued an advisory on ownership and control reporting (OCR) for futures...more

OIG Warns Lab “Pull-Through” Arrangements May Be Illegal

In an important advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (OIG) gave a thumbs-down to a proposed clinical laboratory “pull-through” arrangement even though the patients in...more

OIG Advises that Exclusive Lab Referral Arrangement May be a Kickback

The Department of Health and Human Services Office of Inspector General (OIG) released an advisory opinion (No. 15-04) today that states a proposed arrangement to provide free laboratory tests for certain patients of...more

ITC Pilot Program to Expedite Rulings on Whether Exclusion Orders Cover Redesigns and New Products

On February 24, 2015, the ITC announced a new pilot program to decide whether redesigns or new products are covered by ITC exclusion orders. The announced goal of the program is to test the use of expedited procedures for the...more

Excluded Individual Not Precluded from Payment for Pre-exclusion Services

In Advisory Opinion 15-02 [PDF], issued February 9, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) looked favorably on the Requestor’s inquiry as to whether receipt of Federal health...more

Legal Ethics and Social Media: What Pre-Litigation Advice May an Attorney Provide to His or Her Client?

When meeting with your client about a matter that will likely result in litigation, what advice can you give your client about privacy settings and removal of information from social media in the pre-litigation setting? The...more

OIG Advisory Opinion Sheds Light on Preventive Care Exception

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued an advisory opinion approving an arrangement whereby a licensed entity providing services under a state program for...more

OIG Approves Free Diapers and Playpen in Connection with Medicaid Program Promoting Pre- and Post-Natal Care

On January 26, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving an entity’s practice of advertising and providing free diapers and free portable...more

OIG Approves Nonprofit Foundation's Proposed Copayment Assistance Program

On January 5, 2015, the OIG posted a favorable advisory opinion, OIG Advisory Opinion 14-11, regarding a 501(c)(3) charitable foundation’s (Foundation) proposal to establish a patient assistance program that would provide...more

FCPA Compliance and Ethics Report-Episode 121-FCPA Year in Review, Part II [Video]

In this episode I review the two Opinion Releases, Esquenazi court decision, DOJ communications via speeches on FCPA enforcement. I end with a look at 2015. ...more

Appeals Court Vacates DOL Rule Authorizing Use of Skill-Based Private Wage Surveys in H-2B Temporary Labor Certification...

On December 5, 2014, a panel of the U.S. Court of Appeals for the Third Circuit issued an opinion vacating the Department of Labor (DOL) regulation and related guidance memorandum authorizing DOL, at the request of the...more

No Sanctions for Basic Life Support Service Provider

The Office of Inspector General (OIG) recently issued Advisory Opinion 14-09 [PDF] and concluded that a town that uses tax revenues to cover out-of-pocket expenses owed for basic life support (BLS) emergency ambulance...more

Higher FCPA risks for mergers and acquisitions? Opinion Release 14-02 and your growing business – three steps

The Department of Justice has announced that it would take “no action” against a multinational corporation in connection with its acquisition of a foreign corporation with significant record-keeping deficiencies and a history...more

Tax Court Approves Use of Predictive Coding During ESI Discovery

On September 17, 2014, the U.S. Tax Court issued its first opinion regarding the discovery of electronically stored information (ESI). In Dynamo Holdings, Ltd. vs. Commissioner, 143 T.C. No. 9 (Sept. 17, 2014), the Tax Court...more

FinCEN's Busy August Yields Noteworthy Anti-Money Laundering Developments

August was a busy month for the U.S. Department of the Treasury's Financial Crimes Enforcement Network (FinCEN). Among other initiatives, FinCEN issued its long-awaited proposed regulations on customer due diligence (CDD)...more

OIG Okays Medigap Insurer’s Arrangement for Discount on Inpatient Deductibles

Last Monday the Office of Inspector General (OIG) of Health & Human Services posted an advisory opinion (No. 14-07) allowing a Medigap insurance company to strike a deal with hospitals for discounts—even waivers—of the...more

OIG Rejects Specialty Pharmacy Request to Pay “Per-Fill” Payents to Retail Pharmacies

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

Comments on SBA's Proposed Rule Regarding Advisory Small Business Size Decisions

Re: Comments on Proposed Rule Regarding Advisory Small Business Size Decisions RIN: 3245-AG59, Docket Number: SBA-2014-7 - Dear Mr. Koppel: We are writing to submit comments regarding the U.S. Small Business...more

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