Advisory Opinions

News & Analysis as of

OIG Tightens Requirements of Prior Favorable Advisory Opinion on Charity Patient Assistance Program for Cancer Drugs

On December 7, 2015, OIG posted a modification adding additional strictures to a prior favorable Advisory Opinion (No. 07-11) regarding a charity’s operation of a patient assistance program (PAP) to provide financial...more

FDIC Advisory Letter on Loan Participations

On November 6th, the FDIC issued an advisory letter discussing risk management practices that FDIC-supervised banks should implement with regards to purchased loans and loan participations. While the FDIC acknowledges the...more

Gaming Legal News: Volume 8, Number 21: Nevada’s Live Entertainment Tax For Events On Gaming Properties Takes Final Form

The Nevada Gaming Control Board (Board) has finalized its changes to the state’s Live Entertainment Tax (LET) assessed on gaming licensees, as mandated by the Nevada Legislature. (We originally reported on the Legislature’s...more

OIG Authorizes Arrangement to Pay for MRI Services

On November 20, 2015, OIG issued a favorable advisory opinion, Advisory Opinion No. 15-14, regarding a charitable organization’s arrangement to pay for magnetic resonance imaging (MRI) services for patients afflicted with a...more

Is There A State Role For Binary Option Regulation?

The North American State Securities Administrators Association (NASAA) recently warned investors about the risks of investing in binary options. While NASAA asserts that many binary trading platforms are “unregulated or are...more

OIG Approves Health System's Complimentary Transportation Program

Recognizing that a narrowly tailored complimentary transportation program may pose minimal risk of fraud and abuse, the OIG posted favorable Advisory Opinion No. 15-13 on October 21, 2015. The Opinion approves an integrated...more

Advisory Opinion: Free van shuttle services to medical facilities

On October 21, 2015 the Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 15-13. This Opinion relates to a request for Advisory Opinion about a plan to offer free van shuttle...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

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

Is Safe Harbor Still Safe? U.S. Companies Face Challenges Ahead on the EU Privacy Horizon

Pursuant to European Commission Decision 2000/520, United States–based companies may freely process the personal data of European Union citizens, provided that those companies adhere to the principles and frequently asked...more

OIG Approves Home Health Provider's Free Introductory Visit Policy

On August 6, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a for-profit home health provider’s policy to offer free introductory visits to...more

OIG Issues Advisory Opinion No. 15-12: Free Home Health Provider Visits Do Not Violate Anti-Kickback Statute

The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a new advisory opinion finding that free introductory visits (the “Introductory Visits”) for patients offered by a home health...more

OIG Issues Advisory Opinion Regarding Pharmaceutical Manufacturers’ Program to Provide Free Limited Drugs to Beneficiaries When...

On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more

OIG Issues Two Favorable Advisory Opinions

OIG recently issued two favorable advisory opinions. On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria...more

ESMA Confirms Renewal of Short Selling Ban by Greek HCMC and Market Making Exemption

On August 3, the European Securities and Markets Authority (ESMA) issued an official opinion (Opinion), agreeing to renew for a further four weeks the emergency short selling prohibition originally imposed by the Hellenic...more

OIG Issues Favorable Advisory Opinion Regarding Employee Lease Arrangement Between Related Entities

Reviewing an arrangement involving the lease of employees and other operational and management services between a health system and its related psychiatric hospital, the OIG issued a favorable advisory opinion, Advisory...more

OIG Issues Favorable Advisory Opinion of Hospital Leasing Arrangement

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees...more

FCC Open Internet Advisory Procedures - Possibilities and Potential Pitfalls

As we head into this long holiday weekend, the FCC gives us something to think about. To seek guidance or not to seek guidance, that is the question. Today, the FCC released its Open Internet Advisory Opinion Procedures....more

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

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