Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel
event
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

This unique conference is dedicated to equipping your medical staff team with the most current skills, tools, and information to navigate challenging issues and provide effective leadership. This year’s conference will address recent legal and regulatory updates, and explore significant new laws and court decisions impacting medical staffs. We will also cover recent trends in medical staff litigation and explore the post-election impact of the new president and congress on the health care industry.

Planned Sessions Include:

Continue Reading →
Compliance Program Development & Counseling, HIPAA / Health Privacy & Security, Hospitals and Acute Care
alert
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).

Continue Reading →
Office of Inspector General Developments, Prescription Drug Pricing & Government Price Reporting
alert
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. The portfolio features planned work, completed reports, industry guidance, and enforcement actions.”  

Continue Reading →
False Claims Act
alert
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. The government alleged that Baxter submitted false claims for a drug sold to the Department of Veterans Affairs and Department of Defense, as well as reimbursed by the Medicare and Medicaid programs, because the drug was “adulterated,” given Baxter’s alleged violations of the Federal Food, Drug, and Cosmetic Act’s (FDCA) current good manufacturing practice (cGMP) requirements – but not because of any impact on the drug itself.

Continue Reading →
HIPAA / Health Privacy & Security
alert
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. New IT agreements should cover the risks, and existing agreements should be reviewed to determine whether they still provide the necessary protection.

Continue Reading →
Home Health Care, Hospices and Palliative Care, Hospitals and Acute Care
webinar
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.

As you might know, the California Division of Occupational Safety & Health Standards Board recently approved a new safety standard designed to provide comprehensive regulatory protections for workers exposed to workplace violence in health care settings. The standard, which was sponsored by several labor unions, will require covered health care providers to develop workplace violence prevention plans, training programs, conduct safety and security assessments, and recordkeeping procedures to track certain incidents of workplace violence.

Continue Reading →
Home Health Care, Hospices and Palliative Care, Hospitals and Acute Care, Litigation & Alternative Dispute Resolution, Long Term Care
alert
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. Hold-Weiss will focus on regulatory, transactional, and litigation matters for health care providers, primarily hospices, home health agencies, skilled nursing facilities, and assisted living facilities.

Continue Reading →
alert
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 executive order on January 30, 2017 requiring agencies and executive departments to “identify at least two existing regulations to be repealed” whenever they propose or promulgate a new regulation.

Continue Reading →
Fraud & Abuse Compliance, Media Mention
alert
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. The rule withdrawal followed a January 30 executive order from President Trump calling for the elimination of two regulations for every new regulation. Ms. Baumann noted that the “two-for-one” order decreases the likelihood that many new fraud and abuse regulations will be issued in the near future.

Continue Reading →
alert
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. Days later, on January 30, President Trump signed an executive order that requires agencies to repeal at least two pre-existing regulations for every new regulation issued. These actions signal the start of the Trump Administration’s efforts to scale back and eliminate some of President Obama’s key regulatory initiatives, and to reduce the compliance costs stemming from regulations going forward.

Continue Reading →

Pages

SUBSCRIBE

Add the Arent Fox Health Care Law blog to your RSS feed reader.

Arent Fox In Your Inbox
To subscribe to Arent Fox Alerts and other news, click here.

ABOUT ARENT FOX LLP

Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.