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Health Law Advisor Blog

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Unpacking Averages: Violations Found in Medical Device Warning Letters

USA - June 1 2022 Most companies want to avoid FDA Warning Letters. To help medical device companies identify violations that might lead to a warning letter, this post…

No Surprises Act Update - New IDR Guidance

USA - April 21 2022 On April 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued new guidance on the Independent Dispute Resolution (IDR) process…

CMS Ending Numerous COVID-19 Blanket Waivers for SNFs, Inpatient Hospice, ICF/IIDs, and ESRD Facilities

USA - April 8 2022 On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued guidance terminating numerous blanket waivers applicable to skilled…

HHS OCR Issues Annual HIPAA Reports to Congress

USA - April 8 2022 The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently submitted two reports to Congress setting forth the HIPAA…

Unpacking Averages: Connecting Published Clinical Trials with FDA Drug Approvals

USA - March 1 2022 I recommend against relying on any data I provide in today’s post. I hope the data are at least somewhat accurate. But they are not nearly as…

Federal District Court Vacates QPA Rebuttable Presumption Provisions of No Surprises Act Regulations

USA - February 28 2022 On February 23, 2022, in the case captioned Texas Med. Ass’n v. U.S. Dep’t of Health & Human Servs., No. 6:21-cv-00425-JDK (E.D. Tex.), the U.S…

Cookies Resulting in Cross Border Transfers of Personal Data to the United States Draw Scrutiny from European Data Privacy Regulators

European Union, USA - February 28 2022 Recent decisions from the European Union (EU) have placed renewed focus on the use of common cookies used on ecommerce and other websites used by…

CMS Releases No Surprises Act State Enforcement Letters

USA - February 15 2022 During a National Stakeholder Call on January 18, 2022, Ellen Montz—Deputy Administrator and Director of the Center for Consumer Information and…

CMS Discontinues Prior Guidance on Visitation Restrictions and Rescinds COVID-19 Focus Infection Control Survey Procedures

USA - February 11 2022 On February 4, 2022, the Centers for Medicare and Medicaid Services (CMS) issued important updated guidance in a memo (QSO-21-08-NLTC) regarding how…

Unpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects

USA - February 1 2022 The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to…