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Keeping you afloat admidst the rising sea of regulations

Top Health Care Advisor Rachel Hold-Weiss Returns to Arent Fox

Arent Fox LLP is pleased to announce the return of health care regulatory attorney Rachel Hold-Weiss as a partner in the firm’s New York office. Ms. Hold-Weiss is re-joining Arent Fox after serving as the Associate General Counsel and Corporate Compliance Officer for the Personal-Touch Home Care companies. A welcome addition to the firm’s nationally recognized Health Care practice, Ms.

Trump’s 2-for-1 Executive Order and its Impact on FDA

On the heels of a January 20, 2017 memorandum freezing the release of any new or pending regulations until they have been reviewed and approved by Trump Administration appointees, the White House issued an

Health Fraud Rule Withdrawal May Hurt Enforcement Efforts

Partner Linda Baumann was recently quoted in the Bloomberg BNA article, “Health Fraud Rule Withdrawal May Hurt Enforcement Efforts,” appearing in both the Health Care Daily Report and the Medicare Report. The article discusses how fraud enforcement efforts in the health care industry may be hindered by the Trump Administration’s delay of a program integrity final rule that would have strengthened the government’s ability to suspend or revoke provider enrollment in Medicare and Medicaid.

Trump Administration Orders Regulatory Freeze and the Elimination of Two Pre-existing Regulations for Every New Regulation Issued

On January 20, 2017, President Trump’s Chief of Staff, Reince Priebus, issued a memorandum implementing an immediate regulatory freeze of any new or pending regulations until they have been reviewed and approved by Trump Administration appointees.

Health Care Compliance Association (HCCA) Webinar: Navigating the Rest of the Iceberg - Privacy and Security Compliance Beyond HIPAA

Please join Arent Fox partners Sarah Bruno, Jade Kelly and Matthew Mills on Tuesday, February 21 from 1:00-2:30 PM Eastern for a Health Care Compliance Association webinar titled Navigating the Rest of the Iceberg: Privacy and Security Compliance Beyond HIPAA. 

FDA Finalizes Guidance on Assessing New Drug Abuse Potential

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.

The Secret's Out: FDA Allows Drug and Device Manufacturers to Share HCEI Prior to Product Approval

Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers, describing the Agency’s expectations for drug and device manufacturers’ communication of health care economic information (HCEI) about their products t

How Millennials Will Change Health Care IT

* The following article was originally published by Healthcare Business & Technology. To read it on the Healthcare Business & Technology website, click here. 

CMS Rule Prohibiting Binding Arbitration Put on Hold

* The following article was originally published by California Healthcare News. To read it on the California Healthcare News website, click here.