As HIPAA-regulated entities anxiously await the commencement of the Phase II HIPAA audit program, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has issued a report critical of the Office for Civil Rights’ (OCR) HIPAA enforcement performance, effectively giving OCR “something to prove.” The report, released on September … Read more
The U.S. Department of Justice (DOJ) issued a
Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained a preliminary injunction that prevents the Agency from bringing misbranding charges against the company for making truthful statements to doctors about off-label … Read more
Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained a preliminary injunction that prevents the Agency from bringing misbranding charges against the company for making truthful statements to doctors about off-label … Read more
On July 7th, the House introduced much anticipated bipartisan telehealth legislation. The Medicare Telehealth Parity Act of 2015, introduced by Representative Mike Thompson (D-CA) and co-sponsored by Representatives Gregg Harper (R-MS), Diane Black (R-TN), and Peter Welch (D-VT), would gradually increase the scope of telehealth services covered by Medicare and addresses many of the current limitations … Read more
Recently, South Carolina U.S. District Judge Joseph Anderson, Jr. issued an opinion in which he struggled with how to handle a non-intervened qui tam brought under the Federal False Claims Act (FCA). In his opinion, Judge Anderson requested that the United States Court of Appeals take an interlocutory appeal to determine two issues: The extent of the government’s right … Read more
A tip from a local Denver news outlet lead to a compliance review, investigation and ultimately a resolution agreement between the Department of Health and Human Services’ Office for Civil Rights (“OCR”) and Denver-based Cornell Prescription Pharmacy (“CPP”). On January 11, 2012, 9 News, the Denver NBC news affiliate, reported to OCR that certain patient information was being disposed … Read more
Yesterday the Office of Inspector General for the Department of Health and Human Services (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory and a physician practice could potentially generate prohibited remuneration under the Anti-Kickback Statute and also subject the laboratory to certain administrative sanctions. Notably, the OIG also … Read more
Mother Nature claimed another victim this week. The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program. But with another winter storm aimed at Washington, the hearing was cancelled. The cancellation came after witnesses had submitted their written testimony to subcommittee … Read more
Last week, the Texas Medical Board issued a proposed rule (the “Rule”) clarifying that physicians must perform a face-to-face or in-person physical examination of a patient prior to issuing a prescription or risk sanctions for unprofessional conduct. The Rule states that a physician cannot prescribe any drug “without first establishing a defined physician-patient relationship,” which includes, among … Read more