News & Analysis as of

Advisory Opinions

OIG Rescinds Advisory Opinion Due to Requestor’s Failure to Disclose Information

On November 28, 2017, the Office of Inspector General (OIG) rescinded advisory opinion 06-04, in which it had previously determined that a charity’s (Requestor) proposal to provide assistance to financially needy Medicare...more

OIG Rescinds Advisory Opinion

by Holland & Knight LLP on

The Department of Health and Human Services Office of Inspector General (the OIG), on November 28, 2017, issued a Rescission Letter terminating Advisory Opinion Number 06-04 (Advisory Opinion 06-04). In Advisory Opinion...more

OIG Advisory Opinion 17-06: Another Medigap/PHO Arrangement Approved

by Baker Ober Health Law on

Advisory Opinion 17-06 joins a long list of opinions approving arrangements between a Medicare Supplemental Health Insurance (Medigap) insurer and a preferred hospital organization (PHO). While this advisory opinion does not...more

FTC Advisory Opinion Says Hospital’s Proposed Prescription Program for Affiliated Entity Employees is Exempt from Robinson-Patman...

by Foley & Lardner LLP on

On November 7, 2017, the Federal Trade Commission (FTC) released an advisory opinion confirming that a non-profit hospital in New York may sell discounted prescription drugs to the employees of an affiliated medical practice...more

Pa.L.C.B. Issues Guidance on Decorative Bottles in a Licensed Establishment

The Pennsylvania Liquor Control Board issued an Advisory Opinion regarding a licensee’s use of empty liquor or wine bottles as decoration in their restaurant. The inquiry came from a Pennsylvania licensee who requested a...more

CMS Advisory Opinion 2017-01 Approves Pop-up Alerts to Physicians Through Online Laboratory Portal

by Baker Ober Health Law on

A clinical laboratory has received a green light from CMS to offer pop-up notifications alerting physicians of various potential issues (Laboratory Alerts) through its web-based portal for ordering and reporting results of...more

CFTC’s Enforcement Division Announces New Focus on Self-Reporting

Upon discovering a potential violation, a company is often faced with the dilemma of whether to self-report the incident to its regulator or attempt to deal with the incident through exclusively internal means. On September...more

CFTC’s Updated Enforcement Advisory Attempts To Shift Incentives In Favor Of Self-Reporting And Full Cooperation

On September 25, 2017, the Division of Enforcement (Division) of the US Commodity Futures Trading Commission (Commission) issued an “Updated Advisory On Self Reporting And Full Cooperation.” The Enforcement Advisory was...more

OIG Approves (Yet) Another Medigap/PHO Arrangement in Advisory Opinion 17-04

by Baker Ober Health Law on

With Advisory Opinion 17-04, issued August 24, 2017, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) adds to the ever-growing number of favorable advisory opinions regarding an agreement...more

Pharmacy Chain's Benefit Program Gets OIG Approval in Advisory Opinion 17-05

by Baker Ober Health Law on

The OIG approved a retail pharmacy chain's proposal to expand its benefit program, which allows participating federal health care program beneficiaries to receive discounts and other benefits when purchasing certain products...more

Binary Options And Securities Regulation

by Allen Matkins on

Recently, the North American Securities Administrators Association (NASAA) updated and expanded its 2015 advisory warning investors about online binary option schemes. NASAA offers the following explanation of “binary...more

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

by Baker Ober Health Law on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

OIG issues Advisory Opinion on a Retail Pharmacy’s Paid Membership Program Which Includes Federal Health Care Program...

by Dorsey & Whitney LLP on

On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes...more

Sale of Fractional Aircraft Shares Not Taxable Under New York Law

by Benesch on

New York’s Department of Taxation and Finance recently released an Advisory Opinion concluding that the sale of fractional aircraft shares are not taxable under state law. New York tax law imposes sales and use tax on retail...more

New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

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

Steps for Limiting Liability as Local Counsel

by Dentons on

Many litigators have either sought or served as local counsel at least once in their careers. Litigators with national practices may work with local counsel more often than not. Those with niche practices based in specialized...more

EU Court confirms EU competence on wide range of trade areas in opinion on EU-Singapore FTA

by White & Case LLP on

Following the Advocate General's related advisory opinion in December 2016, the Court of Justice of the EU (CJEU) has delivered its Opinion (2/15) on the EU-Singapore FTA. While the Court's Opinion confirms that the EU alone...more

Louisiana Insurance Regulator Confirms Innovator-Friendly Approach to Anti-Rebating

The practice of rebating has long been prohibited in nearly every state across the country. Despite this long-standing and widespread prohibition, the full scope of services that are and are not permissible under each state’s...more

Healthcare Law Update: March 2017

by Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals - On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more

"CFTC’s Enforcement Division Issues New Advisories on Cooperation"

On January 19, 2017, the U.S. Commodity Futures Trading Commission’s Division of Enforcement issued two new enforcement advisories outlining the factors the division will consider in evaluating cooperation in the agency’s...more

A Cloud on the Horizon? Attorneys’ Obligations when Using a Third-Party’s Cloud-Based Services

When we think of clouds, we likely picture cumulus, stratus, and cirrus ones, not the type of “cloud” that holds data and software. The latter type of cloud is generally controlled by a third-party service provider and is...more

Worker Classification in Massachusetts: Uber Drives Attention to Employees vs. Contractors

by Bowditch & Dewey on

Uber Technologies, Inc. continues to fight claims all over the world that it should treat drivers it matches with passengers as employees rather than independent contractors. Since the business of on-demand employment is...more

EU Court's Advocate General delivers opinion on EU-Singapore FTA

by White & Case LLP on

An Advocate General of the Court of Justice of the EU (CJEU) has delivered an advisory opinion on the EU-Singapore FTA. In this opinion – which is non-binding on the Court, but would normally influence its decision – AG...more

OIG Approves Another Medigap/Preferred Hospital Network Arrangement in Advisory Opinion 16-11

by Baker Ober Health Law on

On November 3, 2016, the OIG issued another favorable Advisory Opinion, No. 16–11, regarding an agreement between a Medigap insurer and preferred hospital network. The OIG has issued several opinions regarding similar...more

New Anti-Kickback Safe Harbors

by Roetzel & Andress on

On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et...more

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