Health Care Counsel Blog

On December 30, 2014, the Department of Health and Human Services Office of Inspector General (OIG) published its annual solicitation for the development and/or modification of safe harbor provisions under the Federal Anti-Kickback Statute.

The Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 14-11 addressing a charitable foundation’s request to provide cost-sharing assistance to financially needy patients diagnosed with either Crohn’s disease or ulcerative colitis.

It will be interesting to see if the Rule survives the judicial, and perhaps even legislative, challenges it may face. If you have any questions about the Rule, please contact the authors of this post or the Arent Fox professional who handles your matters.

On November 20, 2014, the US Department of Justice (DOJ) reported that False Claims Act recoveries from civil settlements and judgments in Fiscal Year 2014 (ending September 30) reached a record $5.69 billion.

In a decision that is good news for California hospitals, the California Court of Appeal invalidated class certification when a San Diego-based hospital system proved that the only way to determine the members of an uninsured patient class was to review more than 120,000 patient records.

The government’s recent and ongoing emphasis on eliminating health care fraud, waste and abuse appears likely to increase criminal prosecutions.

The 2014 midterm Congressional elections have resulted in a significant wave of victories for the Republican Party that confers new majority status in the US Senate and expands the majority in the US House of Representatives.

On October 23, 2014, we sponsored a webinar about the escalating cybercrime threat to the health care industry, with analysis of some of the legal issues and suggestions on how to prepare for such an attack.

In an effort to encourage hospitals to take advantage of the 68 percent settlement offer for previously denied inpatient claims, [1] the Centers for Medicare and Medicaid Services (CMS) recently announced a new procedure.

Health care organizations are increasingly under attack from cybercriminals seeking to gain access to confidential data and to Internet connected medical devices. Health care cybercrime is a reality. Are you prepared?

The Seventh Circuit Court of Appeals recently affirmed a lower court’s conclusion that a doctor in a service corporation was actually an employer, and thus could not bring a claim under federal discrimination statutes based upon her termination

As part of a case we continue to follow, in which the US Department of Justice (DOJ) intervened in a False Claims Act (FCA) suit against Continuum Health Partners and Mount Sinai Health System, the defendant hospital system recently filed a motion to dismiss the DOJ’s complaint-in-intervention.

Representatives for the Centers for Medicare and Medicaid Services (CMS) held a conference call on October 9, 2014 to address ongoing questions and clarify the requirements for hospitals that want to settle the inpatient-status claims whose denials they have appealed.

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

The exposure frequently arises because physicians bargain hard for the highest possible level of compensation, and the government (or a whistleblower) later alleges that the compensation exceeds fair market value or is not commercially reasonable.

The Department of Health and Human Services Office of Inspector General (OIG) released a proposed rule adding new safe harbor provisions to the Federal Anti-Kickback Statute (AKS) and expanding exceptions to the Beneficiary Inducement Civil Monetary Penalty Statute (Proposed Rule).

The Centers for Medicare & Medicaid Services (CMS) announced plans to reopen and extend the deadline for eligible professionals and eligible hospitals to submit a hardship exception application for not demonstrating “Meaningful Use” of Certified Electronic Health Record Technology (CEHRT).

The Centers for Medicare and Medicaid Services (CMS) recently announced a policy allowing acute care and critical access hospitals to settle inpatient-status claims currently on appeal in exchange for a partial payment equal to 68 percent of the claims’ net allowable amount.

The Study determined that the annual cost of an MET comprising a nurse, respiratory therapist, and ICU fellow, with concurrent patient care responsibilities independent of MET duties, was equivalent to the cost savings associated with a reduction of about 3.5 patient deterioration events per year.

On September 30, 2014, the US Court of Appeals for the Ninth Circuit unanimously held that the first-in-the-nation Safe Drug Disposal Ordinance passed by Alameda County, California is constitutional.

On September 25, 2014, Law360 published an article by Arent Fox partner Peter R. Zeidenberg that addresses just that type of DOJ statement.

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.