Medical devices are subject to numerous regulations and an intensive approval process to verify their safety for patient use–but what about the software that powers these devices? How secure is the software that operates insulin pumps or pacemakers? In addition to the requirement that medical device software meet general Food […]
Health Law Alert
New Focus on Immediate Jeopardy: Revisions to Appendix Q
Appendix Q to the State Operations Manual sets out surveyor guidance regarding Immediate Jeopardy findings. The revised guidance published by CMS in a Quality, Safety and Oversight Memo on March 5, 2019, includes a “Core” Appendix Q applicable to all provider and supplier types. Two subparts, applicable to nursing homes […]
Case Law Update: The Iowa Supreme Court Bars Dentists from Recovering Denied Reimbursement Claims for Covered Services from Medicaid Patients
On February 8, 2019, the Iowa Supreme Court, in Colwell v. Iowa Department of Human Services1 , limited dentists’ billing rights under Iowa Medicaid (“Medicaid”) by concluding that dentists cannot charge Medicaid patients when the managed care organization (“MCO”) denies reimbursement for covered services. In 2014, Iowa’s Medicaid expansion program […]
EEO-1 Filing Deadline Extended
On February 1, 2019, the EEOC announced its extension of the EEO-1 filing deadline to May 31, 2019. The EEO-1 survey must be filed annually by private employers with 100 or more employees, and by federal contractors with 50 or more employees and a federal contract/subcontract in excess of $50,000. […]
Patient Access Makes Headlines (Again)
The Healthcare Information and Management Systems Society (“HIMSS”) conference took place earlier this month. During his session at the conference, OCR Director Roger Severino announced a new enforcement initiative emphasizing compliance with patients’ rights of access to their health information. When asked to comment on this announcement, an HHS spokesperson […]