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Keeping you afloat amidst the rising sea of regulations

Substance Abuse Medical Record Privacy Rules Updated For The First Time in Nearly 30 Years

For the first time in nearly three decades, the Substance Abuse and Mental Health Services Administration (SAMHSA) has updated the regulations on the confidentiality of substance abuse treatment records found in 42 C.F.R. Part 2 (the Part 2 Regulations).

Medical Staff Leaders and the Law Conference 2017: San Francisco

Please join Arent Fox on Friday, March 10 from 8:00 AM - 1:00 PM Pacific for our annual half-day Medical Staff Leaders and the Law Conference being held at the Olympic Club in San Francisco.About this Arent Fox Conference

New OIG Drug Pricing and Reimbursement Portfolio Now Online

Have you been wondering what OIG has done regarding drug pricing and reimbursement since 2010? Today, OIG has made it easier to find out, posting a Drug Pricing and Reimbursement Web portfolio on its website. According to an OIG announcement, the portfolio “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs.

Your Money or Your Patients: Using IT Contracts to Protect Against Ransomware Attacks

An Austrian hotel was a recent victim of a “ransomware” computer attack that disabled its electronic room key system and locked up its own computers, and this follows ransomware attacks on hospitals. These attacks demonstrate that hospital administrators should be sure that IT agreements adequately address the risks of cyberattacks. Moreover, this important lesson applies to health care institutions as ransomware causes great harm because it locks up and makes patient and other records unavailable at the very time they are required for ongoing medical care.

Recent Drug Company Settlement Highlights Unique Theory of False Claims Act Liability: Failure to Follow Current Good Manufacturing Practices

Last month, Baxter International Inc. and Baxter Healthcare Corporation (collectively “Baxter”) settled a qui tam False Claims Act (FCA) case with the Department of Justice (DOJ) for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.

What You Need to Know: New CALOSHA Workplace Violence Rules for Health Care Facilities

Please join us for a free webinar (noon-1:00 pm PT/3:00-4:00 pm ET) designed to help health care facilities prepare for the new CALOSHA regulation that addresses the threat of workplace violence.

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

Health Counselor 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.