Articles and Blogs

Executive Summary In an interesting Medicare Integrity Program case examining conflicting provisions 42 U.S.C. § 1395ddd(f)(3)  and 42 U.S.C. § 1395kk(a) (the “Medicare Statute”), the U.S. Court of Appeals for the D.C. Circuit (the “Court”) upheld a decision of a federal district court, concluding that the Secretary of the Department of Health and Human Services... READ MORE

In 2007, the majority of physicians responding to an American Society for Dermatologic Surgery (“ASDS”) survey reported that the number of patients they were treating for complications caused by non-physicians was increasing.  These complications frequently involved burns caused by the improper use of lasers, scarring caused by chemical peels, hyperpigmentation caused by laser hair... READ MORE

Executive Summary On July 23, 2013, the Health Resources and Services Administration (“HRSA”) released a long-awaited final rule clarifying the scope of the 340B Program’s “Orphan Drug” exclusion, which was established as part of final reconciliation under the Patient Protection and Affordable Care Act. 340B Program participating hospitals subject to this Final Rule include free-standing... READ MORE

Executive Summary In a case of first impression, Council for Urological Interests v. Sebelius, D.D.C., No. 1:09-cv-0546, 5/24/13, the federal district court for the District of Columbia (the “Court”) interpreted certain 2008 changes to the Stark regulations having far-reaching effects on “under arrangements” contracts between hospitals and physician-owned service providers.  The Court held  that... READ MORE

Two recent federal court decisions have changed the landscape of off-label prescription drug marketing by pharmaceutical companies.  While providers may prescribe U.S. Food and Drug Administration (“FDA”)-approved drugs for off-label uses, pharmaceutical companies and their representatives are prohibited from promoting the use of FDA-approved drugs off-label as the Federal Drug and Cosmetic Act (“FDCA”)... READ MORE

Executive Summary On June 27, 2013, the Department of Health and Human Services Office of Inspector General (“OIG”) posted advisory opinion 13-06 (“AO”) in which it considered whether a proposal by a licensed offeror of Medigap policies to indirectly contract with hospitals for discounts on otherwise applicable Medicare inpatient deductibles for its policyholders and... READ MORE

On July 11, 2013, the Department of Health and Human Services (“HHS”) announced that it reached a settlement with a large national health insurance company (“Company”) stemming from alleged violations under the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule. The HHS Office for Civil Rights (“OCR”) initiated its investigation after the Company... READ MORE

On June 6, 2013, the United States District Court of the Northern District of Indiana granted a motion for summary judgment for an Indiana hospital, holding the Indiana Peer Review Statute grants immunity in the earliest stages of an initial (or “pre-peer review”) investigation and during communications regarding physician credentialing. This case provides reassurance... READ MORE

Executive Summary On June 13, 2013, the Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 13-03 (“AO”), in which it considered whether a clinical laboratory’s proposal to contract with physician practices to enable the practices to provide clinical lab services to their non-federal health care program beneficiaries only,... READ MORE

On June 13, 2013, the Department of Health and Human Services (“HHS”) announced that it reached a settlement with a California medical center (“Medical Center”) stemming from alleged violations under the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule. The settlement follows an investigation by the HHS Office for Civil Rights (“OCR”) that... READ MORE