Category: Laws & Regulations

Laws & Regulations

91 More Reports of Death in Philips Recall-Related Reporting

The FDA updated its safety communication on the Philips’ recall to include reporting of medical device reports received from August 1 to October 31, 2022.

Laws & Regulations

Federal Infant Sleep Products Safety Standard Takes Effect

The new Safety Standard for Infant Sleep Products makes it unlawful to sell non-compliant infant sleep products and applies to products manufactured on or after June 23.

Laws & Regulations

FDA Proposes Philips Offer Refunds as Option in CPAP Recall

Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price.

FDA

Connecticut Attorney General Urges FDA to Expedite Philips CPAP Replacement

AG William Tong has called on the company to provide replacement machines, reimbursement, and repair guidance.

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Updating Medicare Coverage for Sleep Apnea, Hypoventilation Syndromes, & More: Panel Takes Step Toward Fixing Outdated National Coverage Determinations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

VA Employee Steals $1.9 Million Worth of CPAP Equipment

Kevin Rumph Jr. used his government-issued purchase card to make unauthorized purchases of CPAP supplies from a supplier in Alabama.

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.