Articles and Blogs

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 cancer…Read More

Committee Releases New Doc Fix Draft On July 18, the House Energy and Commerce Committee released an updated framework to replace Medicare’s physician payment system.  The framework represents the first draft proposal to include Democrats’ names, including the ranking member Rep. Henry Waxman (D-CA) and Subcommittee on Health ranking member Frank Pallone (D-NJ).  The Subcommittee on…Read More

A question that employers very often face is whether an employee who leaves employment is entitled to be paid their accrued vacation pay.   The answer is:  it depends.  Courts in Indiana have addressed the vacation pay question for decades. But now, for the first time, the Indiana Supreme Court has spoken with clarity by expressing…Read More

As we get further into the 2013 Atlantic hurricane season and experience more severe weather and wildfires, now is the time to review and refresh your IT disaster recovery plans and business continuity plans.  The Federal Emergency Management Agency Ready website and U.S. Department of Health and Human Services HRSA website provide example business continuity…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 the…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”) prohibits…Read More

On July 12, 2013, CMS issued S&C: 13-46-ALL regarding changes for State Survey Agency (“SA”) obtaining OCR information from providers seeking initial enrollment in the Medicare program or for providers undergoing a change of ownership (“CHOW”).  In the past, the SAs would send the provider an OCR clearance request with the initial Medicare enrollment packet.  The…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 provide…Read More

Expanded access to health coverage for employees and other individuals under the Affordable Care Act (“ACA”) is set to take effect in January of 2014.  However, employers should be aware that certain provisions of the Act require more immediate action on their part.  More specifically, employers are required to provide notice to employees of tax…Read More

Early this month, a Treasury official announced in a blog that the Obama Administration would delay implementation of certain health care coverage reporting requirements and the “pay or play” shared responsibility payments under the Affordable Care Act (“ACA”).  (See July 3, 2013 Hall Render blog post “Obama Administration Takes Its Foot off the Gas Pedal, Announces…Read More