Recent 3.9 Million HIPAA Settlement Over Improper Disclosure of Research Participant PHI Highlights Need for HIPAA Compliance

On March 17, 2016, the Department of Health and Human Services Office for Civil Rights (OCR) announced a $3.9 million settlement with Feinstein Institute for Medical Research for potential violations of the HIPAA Security Rules. OCR began an investigation after Feinstein filed a breach report indicating that a laptop computer containing electronic protected health information (ePHI) of approximately 13,000 patients and research participants was stolen from an employee’s car. The ePHI at issue included research participant names, dates of birth,… Read More >

When is an Overpayment Identified?

The Affordable Care Act (“ACA”) amended the False Claims Act (FCA) “reverse false claims” provision to include an obligation that providers report and return any overpayment within 60 days of identification.  However, the ACA did not define identification which has caused considerable confusion among health care providers. In the recent whistleblower/false claims case of Kane v. Healthfirst, Inc., a federal district court judge has defined the term very narrowly, to mean that the overpayment is identified when the provider is… Read More >

Recent CMS Guidance Clarifies Physician Face-to-Face Home Health Certification Responsibilities

In MLN Matters Number MM9119 issued on April 10, 2015, CMS published manual updates to the physician certification and recertification requirements for home health care.  CMS stated that it is putting the following three changes to the face-to-face requirements in place: Elimination of the narrative requirement. The date and attestation of the physician’s face-to-face encounter will still be required and there must be supporting documentation in the physician’s or post-acute provider’s medical records. If an HHA claim is denied the… Read More >

2 Laboratories Pay $48.5 Million to Settle Anti-Kickback Claims

According to a recent Department of Justice press release, two cardiovascular testing laboratories – Health Diagnostic Laboratories (“HDL”) and Singulex – recently entered into a settlement agreement for a combined $48.5 million.   The settlements resolve a qui tam complaint which alleged that HDL and Singulex violated state and federal anti-kickback statutes and false claims acts and submitted claims to government and private insurers for “medically unnecessary” services. The settlement was the result of a whistleblower lawsuit which alleged that the… Read More >