Health Care Counsel

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

Health Care Counsel
Fraud & Abuse Compliance, Media Mention
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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.

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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.

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HIPAA / Health Privacy & Security
webinar
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

About this Webinar
This webinar will walk through privacy and security laws commonly overlooked by health care organizations. Topics covered include: The Gramm-Leach-Bliley Act; PCI Compliance; FTC Guidance; Applicable State Laws; and EU General Data Protection Regulation. We will provide useful information for assessing when these laws apply, as well as tips and practical guidance for compliance.

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HIPAA / Health Privacy & Security
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At PrivacyCon, Researchers Discuss Today’s New Technologies, Highlight Not-So-New Privacy and Security Issues

What’s New?

On January 12, 2017, the Federal Trade Commission (FTC) held its second PrivacyCon conference. PrivacyCon brings together researchers, academics, industry representatives, consumer advocates, and government regulators, to discuss the latest research and trends related to consumer privacy and data security. This year’s PrivacyCon featured presentations from academics and technology researchers covering the following five main areas: (1) the Internet of Things (IoT) and Big Data; (2) mobile privacy; (3) consumer privacy expectations; (4) online behavioral advertising; and (5) information security. FTC Chairwoman Edith Ramirez, who is stepping down effective February 10, 2017, opened the conference with the myriad of ways consumer data is collected, asking if the risks associated with data collection outweigh the benefits.

Why Should You Care?

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Pharmaceutical & Device Compliance
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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. It provides the agency’s recommendations for timing and design of abuse-related studies, the types of studies that should be included in an abuse potential assessment submitted as part of a new drug application (NDA), and provides general recommendations for consulting with FDA about abuse potential assessment during the drug development process.

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Medical Device Compliance, Pharmaceutical & Device Compliance, Prescription Drug Pricing & Government Price Reporting
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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 to payors, formulary committees, and “other similar entities with knowledge and expertise in the area of health care economic analysis.” What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved. 

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E-Health
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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

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Long Term Care
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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

The use of binding arbitration provisions in healthcare facility admission agreements, particularly those involving nursing facilities, has generated controversy for many years. A new rule recently finalized by the Centers for Medicare and Medicaid Services (CMS) would prohibit the use of such provisions and bar Medicare reimbursement to any nursing facility continuing to include binding arbitration provisions in its admission agreement after November 28, 2016. A recent federal court decision, however, has effectively put a hold on the enforcement of that rule – at least, for now. 

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HIPAA / Health Privacy & Security
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Life’s a Breach - Sitting on that HIPAA Breach Notification Could Burn You

What’s the News?

On January 9, 2017, Presence Health agreed to settle with the U.S. Department of Health and Human Services (HHS) potential violations under the Breach Notification Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This is HHS’ first enforcement action against a covered entity that reported a breach, but did not do so timely.

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E-Health, HIPAA / Health Privacy & Security
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FTC Arms Businesses and Consumers Against Ransomware

Ransomware is a living-nightmare for the health care industry, with attacks or threats of attacks increasing and the consequences potentially devastating to patients and businesses. The Federal Trade Commission recently issued guidance for both businesses and consumers on defending against ransomware, which Arent Fox attorneys Sarah Bruno, Eva Pulliam, and Lourdes Turrecha analyze in the article below.

What’s the News?

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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.