HHS’S New Anti-Discrimination Regulation Proposal Explained – Part 2

By Keith C. Dennen This is the second part in a two-part series about the HHS’s proposed anti-discrimination regulations Gender Identity. Another area addressed in the regulations is “gender identity,” which refers to an individual’s “internal sense of gender, which may be different from that individual’s sex assigned at birth.” The proposed regulations seek to …

HHS’S New Anti-Discrimination Regulation Proposal, Explained

By Keith C. Dennen This is the first part in a two-part series about the HHS’s proposed anti-discrimination regulations. In September, the Department of Health and Human Services (HHS) released proposed anti-discrimination regulations that, if adopted, change the playing field in which physicians and other healthcare providers practice. These regulations are significant because: They apply …

New CMS Proposed Rule Provides Who/What/When for Clinical Laboratory Reporting Requirements Starting January 1, 2016

By Rose Willis Clinical laboratories will see significant changes to their Medicare payments for clinical diagnostic laboratory tests (CDLTs) starting January 1, 2017, but the basis for new payment rates will come from “applicable data” reported by “applicable clinical laboratories” starting January 1, 2016. Failure to report data will subject the applicable laboratory to Civil …

OIG Fraud Alert Regarding Physician Compensation Arrangements: What You Need to Know

By Jessica L. Russell On June 9, 2015, the Department of Health and Human Services’ Office of the Inspector General (“OIG”) issued a new fraud alert regarding physician compensation arrangements, with a particular emphasis on medical director arrangements. The OIG urged physicians to “carefully consider the terms and conditions of medical directorships and other compensation …

Qui Tam Lawsuits and the Statute of Limitations

By Keith C. Dennen In Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter, 575 U.S. ___) (2015), Justice Alito stated “[t]he False Claims Act’s qui tam provisions present many interpretive challenges.” Lawyers and judges who struggle with those challenges understand the truth of that statement. The United States Supreme Court recently …

Responding to Subpoenas and Other Requests for Personal Health Information: Take Them at Face Value

By Billee Ward Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from a variety of sources on a daily basis. Such requests can range from informal requests made during the course of conversation with a patient or family member, to written requests or demands served by law enforcement personnel …

Iowa Supreme Court Affirms Ruling for Health Insurer in Antitrust Dispute

By James M. Burns In late February, the Iowa Supreme Court affirmed a lower court ruling in Mueller v. Wellmark, ending a seven year battle over whether the health insurer’s agreement with employers operating “self-funded” insurance plans to provide the same rate concessions obtained from providers by Wellmark to these plans constituted a per se …

HHS Issues Proposed Rule for Stage 3 of EHR Incentive Program

By Jessica Russell On March 30, 2015, the Department of Health and Human Services (“HHS”) published its proposed rule for Stage 3 the Electronic Health Record Incentive Program (the “EHR Program”). The EHR Program is a three stage program that provides incentive payments to eligible professionals and eligible hospitals and critical access hospitals (“CAHs”) (collectively, …

Legal and Regulatory Landscape for Mobile Health Technologies

By Brian Balow Mobile health (mHealth) technologies continue to expand in application and implementation. Over the past decade, the breadth of these technologies has grown from the creation of healthcare-directed websites (think WebMD) to implanted medical devices that constantly transmit and receive information (sometimes on a device-to-device basis). If you are either a provider or …