Legal and practical healthcare information.
Originally published in Michigan Healthcare Volume 39, No. 12 On December 2, 2022, the US Department of Health and Human Services (“HHS”) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a Notice of Proposed Rulemaking to modify portions of Part 2 of Title 42 of the Code of …
Continue reading “HHS Proposes Rule on Confidentiality of Substance Use Disorder Patient Records”
One year ago, in March of 2020, the Secretary of the U.S. Department of Health and Human Services (Secretary) declared that, because of the public health emergency resulting from the number of confirmed cases of 2019 Novel Coronavirus (COVID), circumstances exist to justify the authorization by the Food and Drug Administration (FDA) of emergency use …
Continue reading “FDA Authorization of COVID Vaccines – What Does it Mean?”
On June 19, 2020, the Department of Health and Human Services (“HHS”) released its final rule[i] (the “Final Rule”) revising its enforcement of Section 1557 of the Patient Protection and Affordable Care Act (“ACA”).[ii] In this rule, HHS reversed many of the requirements of the prior rule issued in 2016 (the “2016 Rule”).[iii] For example, the Final Rule …
Continue reading “Summary of Key Changes to Rules Implementing ACA Nondiscrimination Provisions”
In light of the COVID-19 pandemic, on March 30, 2020, the Secretary of the U.S. Department of Health and Human Services (the “Secretary”) released blanket waivers (the “Waivers”) under Section 1135 of the Social Security Act (the “Act”) as to certain referral-related activities that would normally result in sanctions under the Federal Physician Self-Referral Law, …
Continue reading “Stark Law and Anti-Kickback Statute Waivers for COVID-19”
You’ve probably heard that every provider’s favorite laws, the Anti-Kickback Statute and its related, strict liability counterpart, the Stark Law (formally known as the Physician Self-Referral Law), are getting a makeover from the Department of Health and Human Services (HHS). Here’s what you need to know. Quick Legal Refresher: (A) What is the Anti-Kickback Statute? …
On October 9, 2019, the U.S. Department of Health and Human Services (“HHS”) released newly proposed modifications to the safe harbor provisions for the Federal Anti-Kickback Statute. Among other proposals, HHS is proposing three substantive changes to the personal services safe harbor. Section 1128B(b) of the Social Security Act (commonly referred to as the “Anti-Kickback …
Individuals who use healthcare apps such as fitness trackers, weight loss, wellness, exercise, etc., BEWARE! A couple of recent developments have highlighted the fact that most apps are not subject to HIPAA, which means that with broadly-worded privacy policy these healthcare apps can and do readily share healthcare and other data collected by the apps …