Articles and Blogs

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

Hall Render is pleased to announce attorney Mark Dahlby has been appointed to the Food and Drug Law Institute’s Medical Devices Committee.  The committee advises FDLI staff in formulating and implementing policies and strategies consistent with FDLI’s mission, relating to programs and publications of interest to the medical devices industries. Dahlby has also recently... 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

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. ... 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

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... 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,... READ MORE

CMS Releases Hospital Outpatient Rule On July 8, CMS published a proposed rule for the hospital outpatient and ambulatory surgical center payment systems and the electronic health records incentive program.  Under the proposed rule, total hospital outpatient payments under Medicare are projected to increase next year by nearly $4.4 billion, or 9.5% over 2013.  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