Health Care Counsel Blog

Under a manufacturer cost-sharing assistance or copay coupon program, the manufacturer of a brand name drug pays some or all of the copayment and/or co-insurance obligations of individuals under their health plans when they fill a prescription for the drug covered by the company’s program.

On Wednesday, September 17, 2014, Leslie Caldwell, Assistant Attorney General for the Criminal Division of the US Department of Justice (DOJ), joined the chorus of federal officials promising heightened criminal enforcement targeting those engaging in fraud against the federal government.

In the Preamble, ONC states it was driven by its goals and timeline to enhance health information exchange by making the program “more effective and less burdensome in achieving regulatory objectives,” while increasing “regulatory flexibility” and promoting further innovation.

An unfortunate trend for defendants in False Claims Act (FCA) cases is continuing as the Eighth Circuit Court of Appeals joined other federal circuit courts in lowering the pleading standards that qui tam relators (whistleblower plaintiffs) must satisfy in FCA cases.

On August 29, 2014, the United States Department of Justice filed an action against two nursing homes located in Watsonville, California for defrauding the Medicare and Medicaid programs.

Our colleagues who represent retailers, technology, and media companies recently wrote that high profile data breaches have resulted in legislative and commercial industry initiatives to better protect consumers’ financial information from data theft.

* The following alert was originally published in California Healthcare News (CHN). To read it on the CHN website, click here.

A new decision from the California Court of Appeal is a positive development for SNFs and their defense attorneys as it may eliminate the use of certain theories and tactics historically utilized in prosecuting elder abuse and negligence cases.

On July 22, 2014, the California Court of Appeal, Third Appellate District, found that patients whose confidential health information had been stolen could not sustain a class action absent an allegation that the information was actually viewed by unauthorized third parties.

On July 28, 2014, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable opinion concerning a drug manufacturer’s program to offer a certain branded drug via an online, mail order pharmacy directly to cash-paying customers at a discounted price.

On July 11, 2014, amendments designed to reform Medicare regulations that the Centers for Medicare and Medicaid Services (CMS) has identified as “unnecessary, obsolete, or excessively burdensome on health care providers and suppliers” became effective.

The DC Circuit recently held that the attorney-client privilege applies to internal investigations, even when the investigations are mandated by law and are not conducted with the sole purpose of obtaining or providing legal advice.

The threat of False Claims Act liability based on the failure to promptly return overpayments is a relatively new phenomenon.

The US Supreme Court this morning granted cert in a closely watched False Claims Act (FCA) case, Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter — a case that raises important questions about wartime suspension of the FCA’s statute of limitations.

The CMS announced this week the appointment of a Provider Relations Coordinator “to help increase program transparency and offer more efficient resolutions to providers affected by the medical review process.”

the Department of Health and Human Services Office of Inspector General (OIG) released a Supplement Specialty Advisory Bulletin entitled “Independent Charity Patient Assistance Programs”, to supplement its Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees.

The initiative, supported by Consumer Watchdog and the trial lawyer association Consumer Attorneys of California, will be assigned a proposition number in early July.

On May 7, 2014, the US Department of Health and Human Services Office of Civil Rights (OCR) announced settlements with two New York-based hospitals totaling $4.8 million for violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules.

On April 26, 2014, the Federation of State Medical Boards approved updated model guidelines addressing the use of telemedicine technology.

On April 22, 2014, the US Department of Health and Human Services Office of Civil Rights (OCR) announced settlements of close to $2 million with two health care entities for violations of the Privacy and Security Rules promulgated under the Heath Insurance Portability and Accountability Act.

In an important victory for health care providers, a federal district court in Illinois recently held that health plans may not simply unilaterally recover overpaid funds from health care providers, but rather must provide the appeal and other procedural protections required under ERISA.

A December 31 memo from Nancy Griswold, Chief Administrative Law Judge (ALJ) of the Office of Medicare Hearings and Appeals (OMHA), delivered bad news to health care providers and suppliers awaiting resolution of long-standing health care appeals.

Earlier this month, Arent Fox Health Care partner Lowell C. Brown published an article in California Healthcare News that provides insight into a key peer review case involving legal principles and individual behaviors that provide critical lessons for hospitals.

The financial impact of this increased RAC activity has grown substantially as well, both in terms of claims denials and the costs associated with responding to the RACs.

Earlier this month, Arent Fox Health Care partner Lowell C. Brown published an article in Bloomberg BNA’s Health Law Reporter that provides an overview of ways hospitals, health systems, and provider groups can manage the noted uptick in disruptive practitioner behavior.