Archive
Wade Emmert
Can Actions Be Considered Remuneration Under the Anti-Kickback Statute?
When discussing the Anti-Kickback Statute (AKS), it’s common to say that “remuneration” can be “anything of value.” That board definition has been called into question by…
FDA to Refuse Medical Device Submissions For Cybersecurity Reasons Beginning in October
Jill McKeon, for Health IT Security: Effective immediately, the US Food and Drug Administration (FDA) will require medical device manufacturers to provide cybersecurity information in their…
FDA Cybersecurity Requirements for Medical Devices Now in Effect
From the HIPAA Journal: On Wednesday, March 29, 2023, the medical device cybersecurity requirements of the $1.7 trillion omnibus spending bill – The Consolidated Appropriations Act,…
A Federal Judge Suspends FDA’s Longtime Approval of an Abortion Pill, but Gives the Government 7 Days to Appeal
Medication abortions typically use two drugs taken together: Mifepristone and Misoprostol. This ruling only affects Mifepristone. The other drug, Misopostol, is still available, but its use…
Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation
When the public health emergency ends, so do many of the waivers that were created to facilitate healthcare during the pandemic. One such concession involves the…
OIG Expands Topics for Frequently Asked Questions
OIG has used various avenues to communicate its views on various healthcare compliance issues, such as advisory opinions, contractor self-disclosures, corporate integrity agreements, and exclusions. In…
Judge Strikes Down ACA’s Preventive Care Requirement
A Fort Worth federal judge yesterday ruled that insurers cannot be compelled under the Affordable Care Act to provide preventative care free of charge to insureds.…
The Med Spa on the Corner Is Probably Breaking the Law
Look better. Feel better. Fountain of youth promises are making med spas one of the fastest-growing segments in healthcare. Botox injections, laser hair removal, IV hydration…
Hospital to Pay False Claims Act Penalty for Allegedly Letting Unsupervised Residents Interpret X-Rays
When a healthcare provider submits claims to Medicare, they are making several implied representations: 1) the service was medicaly necessary; 2) the service was performed; and…
Two nurses sent to prison for illegal kickback scheme
Healthcare providers besides physicians can also violate the Anti-Kickback Statute. And, do not think that only physicians can make illegal refurrals. Paying anyone something of value…