Articles and Blogs

On August 15, 2013, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) released a report titled “Most Critical Access Hospitals Would Not Meet the Location Requirements if Required to Re-enroll in Medicare” (“Report”).  If the recommendations in the Report are fully carried out, it could cause nearly two-thirds... READ MORE

On August 14, 2013, the Department of Health and Human Services (“HHS”) announced that it reached a settlement with a not-for-profit New York health plan (“Health Plan”) stemming from alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy and Security Rules. The settlement comes after an HHS Office for Civil Rights... READ MORE

Executive Summary On August 2, 2013, the Centers for Medicare and Medicaid Services (“CMS”) displayed the acute care hospital and long-term care hospital inpatient prospective payment system final rule for fiscal year 2014 (“Final Rule”). In one provision in the Final Rule, CMS aims to provide physicians and hospitals with a clear benchmark for determining... READ MORE

This article is Part III in a five-part series of articles discussing the recently published federal Physician Payment Sunshine Act (“Sunshine Act”). This article focuses on recent updates and resources provided by the Centers for Medicare and Medicaid Services (“CMS”) to assist in Sunshine Act compliance. The first article in the series provided an... READ MORE

Executive Summary On July 1, 2013, the Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 13-07, addressing a proposed arrangement whereby a medical products manufacturer would offer tiered rebates to customers on a combination of products, some of which are reimbursable under the Federal health care programs (“Proposed... READ MORE

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