Healthcare Law Blog

MAY 16, 2022

On April 29, 2022 , the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”). With a few exceptions, the Final Rule is a wholesale codification of the proposed rule.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

SQA

MAY 24, 2023

The objective is to reinforce actions for the prevention and control of diseases such as dengue and chikungunya, arboviruses transmitted by the Aedes aegypti mosquito. For this, it is necessary to maintain regular active surveillance and vector control so that the risk of disease transmission is reduced.

FDA 40

FDA Licensing Governance Compliance 40

SQA

DECEMBER 16, 2022

SQA Regulatory Surveillance Summary for September and October 2022. This guidance will help applicants interpret how to implement Essential Principles of Medical Device Safety and Performance using information that was issued in March 2020. Agência Nacional de Vigilância Sanitária (ANVISA). CMDE Announcement No. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

Hall Render

AUGUST 12, 2022

On July 15, 2022, the Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) announced its resolution of eleven separate investigations against covered entities for violations of the individual’s right of access under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

HIPAA 74

HIPAA Compliance Licensing Regulatory Compliance 74

Health Law Advisor

AUGUST 10, 2023

In that regard, last September, FDA issued a final guidance on when and how FDA regulates Clinical Decision Support, or CDS, software tools because FDA considers them to be a medical device under FDA’s jurisdiction. [2] That said, it is equally important that federal regulation not duplicate state regulation of the practice of medicine.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

OCTOBER 18, 2022

SQA Regulatory Surveillance Summary for July and August 2022. The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. Health Canada.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Healthcare Law Blog

NOVEMBER 13, 2023

The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars. Below is a summary of some of the Proposed Rule’s key changes.

Medicare 59

Medicare Medicare Medicaid Medicaid 59

SQA

FEBRUARY 26, 2024

The products found, subject to retention and seizure, were retained by the Federal Revenue Service. The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. and Biometik Indústria e Comércio de Cosméticos.

FDA 52

FDA Compliance COVID-19 Public Health 52