Supreme Court Holds That “Pay for Delay” Pharmaceutical Patent Settlements May Violate the Antitrust Laws

By James M. Burns On June 17, the United States Supreme Court issued its highly-anticipated decision in FTC v. Actavis Inc., a case with significant implications for patent law, antitrust law and healthcare law.  The case involved a settlement of a patent infringement lawsuit brought by a branded drug manufacturer against a generic drug maker, …

FTC Commissioner Addresses Tension Between the ACA, ACOs, and Antitrust Law

By Scott Roberts In a recent speech to a healthcare trade group in Washington, Federal Trade Commissioner Julie Brill addressed an issue of concern to many in the healthcare industry – the apparent tension between the Affordable Care Act (“ACA”), Accountable Care Organizations (“ACOs”), and antitrust law. Addressing this perceived tension, Commissioner Brill sought to …

New Guidance for Healthcare Providers Regarding Screening of Employees and Contractors for “Excluded Persons”

By Rose Willis Under the Federal “Exclusions Statute,” a health care provider that arranges or contracts with a person that the provider knows or should know is an excluded person, may be subject to Civil Money Penalties (“CMP”) liability, or exclusion, if the excluded person provides services that are payable, directly or indirectly, by a …

State Efforts to Restrict Health Insurer Use of “Most Favored Nation” Clauses in Provider Contracts Continue to Multiply

By James M. Burns Over the last several years, several states have considered legislation that prohibits health insurers from including “most favored nation” clauses – provisions that guarantee the insurer is receiving as favorable a reimbursement rate from the provider as it offers any other insurer – in their provider contracts. The frequency with which …

Meier v Awaad: Extending the Physician-Patient Privilege Beyond Physicians

By Scott Roberts, Esq. In Michigan, the physician-patient privilege is a statutory privilege enacted to “protect the confidential nature of the physician-patient relationship.” While this privilege previously only extended to prevent physicians from disclosing patient information, a new Michigan Court of Appeals case seems to have changed this. In Meier v. Awaad, No. 310808 (Mich. …

FTC Seeks to Derail Hospital’s Acquisition of A Physician Practice Group on Competitive Grounds

By James M. Burns The FTC, together with the Idaho Attorney General, recently announced that they have filed an action in the United States District Court for the District of Idaho seeking to block St. Luke’s Health System from acquiring Idaho’s largest independent, multi-specialty physician practice group, Saltzer Medical Group.  In announcing the decision to …

Fraud and Abuse Concerns Regarding Physician Owned Medical Device Companies (With Application to All Physician Owned Entities)

On March 26, 2013, the United States Office of Inspector General (“OIG”) issued a Special Fraud Alert (the “Alert”) specifically addressing its longstanding fraud and abuse concerns regarding physician-owned distributorships (“PODs”) that earn revenue from the sale of implantable medical devices (including those that design and manufacture such devices under contractual arrangement) while generally noting …

Anti-Kickback Safe Harbors for Physician Groups

By Scott Roberts, Esq. The federal Anti-Kickback Statute (“AKS”) makes it unlawful to knowingly or willfully pay, offer, solicit or receive any “remuneration” in exchange for referrals of any services or items payable under a federal health care program. There are a number of “safe harbors” to this general prohibition, including safe harbors for office …

IRS Concludes EHR Incentive Payments are Income to Recipient and Reportable to IRS

By Ralph Levy, Jr. The Internal Revenue Service recently concluded that recipients of incentive payments from CMS to utilize electronic health records must include the amounts received in gross income and that CMS must report these payments to the IRS. In addition, the IRS guidance (issued in the form of a Chief Counsel Advice) gave …

FTC allows Organization Proposal to Negotiate Rates with Payors to Go Forward

By James M. Burns On February 13th, the Federal Trade Commission (“FTC”) issued an Advisory Opinion in which they indicated that they would not challenge a decision by an Oklahoma physician hospital organization (“PHO”) to negotiate rates jointly with payors as a horizontal price fixing agreement.  As explained in the Opinion, the PHO was successful …