Category: Laws & Regulations

Laws & Regulations

FDA Authorizes Importation of Tentatively-Approved Narcolepsy Drug

The authorization allows the company to shorten the time to product availability following an anticipated final approval decision from the FDA.

Laws & Regulations

Signifier Receives FDA Nod to Remove Certain Contraindications for eXciteOSA

The FDA approved Signifier’s request to remove certain contraindications for its daytime sleep apnea therapy device, a “milestone” approval Signifier says will allow greater patient reach.

Laws & Regulations

Additional Recall for Certain Philips BiPAP Devices

Philips Respironics recalls more devices but the BiPAP recall is unrelated to the PE-PUR foam issue.

FDA

FDA Approves Nyxoah Genio 2.1 For Use in DREAM Pivotal Study for Obstructive Sleep Apnea

Genio 2.1’s upgrades are entirely related to the external components of the Genio system, as the implantable stimulator remains unchanged.

Patient Rights, Privacy

State Settles With Former University of Iowa Secretary Fired for Sleeping at Work

The Gazette: Peggy Waters reported being diagnosed with sleep apnea in 2014 while working at the university.

Medicare & Medicaid

Updating Medicare Coverage for Sleep Apnea, Hypoventilation Syndromes, & More: Panel Takes Step Toward Fixing Outdated National Coverage Determinations

Lifesaving equipment is being denied payment because of rigid criteria in local coverage determinations and existing coverage provided by CMS is not reflective of rapidly evolving technology in the field.

Fraud & Malpractice

Hospital System that ‘Falsely Diagnosed’ Sleep Apnea to Pay $1M Settlement

Cincinnati.com: The US Attorney's Office alleges that Mercy Health made medically unnecessary claims for machines used to treat sleep apnea.

Financial

European Commission Fines Teva & Cephalon for Delaying Entry of Generic Modafinil

The commission investigation has found that for several years, this “pay-for-delay” agreement eliminated Teva as a competitor and allowed Cephalon to continue charging high prices even if the main modafinil patent had long expired.

Commercial Transportation

Audit: Washington Metro Not Properly Tracking Operator Fatigue & Medical Issues

Washington Post: A Washington Metrorail Safety Commission report finds that Metro needs to ensure that operators take enough days off to stay alert, while getting tested and treated for medical issues such as sleep apnea.