Articles and Blogs

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

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. 

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 filed…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 to…Read More

On July 10, 2013, the Wisconsin Supreme Court released its decision in Dane County v. Sheila W., 2013 WI 63 (per curiam), in which it affirmed the Court of Appeals’ dismissal of the case because the issues were rendered moot, or no longer in controversy, by the expiration of the underlying order appointing a temporary guardian…Read More

Late in the day on July 2, 2013, the Obama Administration announced via two blog posts that it will provide a one-year delay to the implementation of significant aspects of the Affordable Care Act (“ACA”) affecting employers.  This delay applies to: (1) the ACA’s new health care coverage reporting requirements applicable to employers, insurers and/or…Read More