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|USPTO Extends Deadline to Comment on Subject Matter Eligibility Analysis|
Antoinette F. Konski; Foley & Lardner LLP;
July 7, 2014, previously published on June 26, 2014Yesterday at BIO’s session entitled “Patent-Eligibility from the Trenches: Practical Implications of the Supreme Court’s Prometheus (Mayo) and Myriad Decisions” a panel of experts and an engaged audience discussed the controversial USPTO “Guidance for Determining...
|OIG Warns of Anti-kickback Statute Violations in Laboratory Payments to Referring Physicians|
McDonald Hopkins LLC;
July 4, 2014, previously published on June 30, 2014On June 25, 2014, the Office of Inspector General (OIG) issued a special fraud alert entitled “Laboratory Payments to Referring Physicians” which deals specifically with laboratories paying compensation to physicians and group practices for blood specimen collection, processing and...
|A “Virtual Merger” is Underway between Chicago-Area Alexian Brothers Health System and Adventist Midwest Health|
Eric A. Klein; Sheppard, Mullin, Richter & Hampton LLP;
July 4, 2014, previously published on June 25, 2014Chicago-area Alexian Brothers Health System and Adventist Midwest Health signed a non-binding letter of intent to form a joint operating company, a collaboration commonly referred to as a virtual merger. As Alexian brings five hospitals to the agreement and Adventist brings four, the health systems...
|Is the DOJ FCPA Enforcement Hegemony Dead?|
Alexandra M. Gorman, Michael K. Loucks; Skadden, Arps, Slate, Meagher & Flom LLP;
July 3, 2014, previously published on June 26, 2014For nearly 15 years, the United States has had the worldwide corruption enforcement stage to itself, reaping billions of dollars in fines and settlement payments from companies that have acknowledged engaging in bribery in foreign countries. That monopoly, however, may soon end. In a report...
|First-Half Activity Energizes US Capital Markets in 2014|
David J. Goldschmidt, Stacy J. Kanter, Phyllis G. Korff, Michael J. Zeidel; Skadden, Arps, Slate, Meagher & Flom LLP;
July 3, 2014, previously published on June 26, 2014The U.S. equity and debt markets experienced a strong first half of the year. In the first quarter, the U.S. IPO market was the busiest since 2000, more than doubling the number of IPOs from the same period last year. The second quarter was nearly as active, bringing the year-to-date total to 134...
|An Update from the Federal Trade Commission|
Helen J. Kim, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
July 2, 2014, previously published on June 24, 2014The interplay between the Affordable Care Act (ACA), Accountable Care Organizations (ACOs), and antitrust has been a matter of great moment for several years. It has been an issue in litigation such as the Federal Trade Commission’s (FTC) St. Luke’s case. Recently, in a conference,...
|Time Running Out to File Comments on OIG Proposed Rulemaking That Gives OIG Limitless Time to Exclude Providers|
Laura F. Laemmle-Weidenfeld, Heather M. O'Shea, Stephen G. Sozio, Heidi Ann Wendel; Jones Day;
July 1, 2014, previously published on June 24, 2014Statutes of limitation serve an essential purpose in ensuring that claims are timely pursued before evidence becomes stale, and that parties can manage their affairs without a cloud of potential liability hanging over them indefinitely. These purposes apply with particular force in the context of...
|FDA Issues Draft Guidance for Medical Device Data Systems|
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
July 1, 2014, previously published on June 2014On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance to inform manufacturers, distributors, and other entities that FDA does not intend to enforce compliance with the agency’s 2011 regulations governing medical device data systems (MDDS) subject to 21 CFR...
|Government Announces Upcoming HIPAA Audits of Business Associates|
Ray Quinney Nebeker P.C.;
June 30, 2014, previously published on June 25, 2014In the February 24, 2014 Federal Register, the Health and Human Services Office of Civil Rights (“OCR”) announced its plans to survey between 550 and 800 entities during the summer of 2014, preparatory to future OCR audits. OCR further clarified in an April 2014 presentation its...
|Governor Scott Signs Bill Outlawing Six Synthetic Drugs|
June 30, 2014, previously published on June 24, 2014On June 16, 2014, Governor Rick Scott signed into law a bill that outlawed six synthetic drugs. These drugs included four synthetic cannabinoids sold as herbal or incense products, including one marketed as "Crazy Clown," and two hallucinogens. "Crazy Clown" has been reported to...