Health Care Counsel

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

Health Care Counsel
Pharmaceutical & Device Compliance
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Chemical & Life Sciences Litigation: Year In Review

As in previous years, 2016 brought us a combination of both expected and unexpected holdings by the Supreme Court and the Federal Circuit.

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ERISA
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The Ninth Circuit Speaks on Health Care Providers’ ERISA Rights

A recent decision from the Ninth Circuit Court of Appeals in DB Healthcare, LLC v. Blue Cross Blue Shield of Arizona, Inc., No. 14-16518, 2017 WL 1075050 (9th Cir. Mar. 22, 2017) reaffirms that health care providers are not health plan “beneficiaries” with the ability to sue under ERISA. Health care providers may sue under ERISA’s civil enforcement provisions only when armed with robust assignments of benefits and rights from patients and where the governing Plan documents do not prohibit assignments.
 

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Stark Law
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CMS Announces New Rules for Stark Self-Disclosures

On March 28, 2017, the Centers for Medicare and Medicaid Services (CMS) posted a revised Voluntary Self-Referral (Stark) Disclosure Protocol (SRDP), which replaces the prior version of the protocol. Under the Affordable Care Act (ACA), providers generally must return overpayments within 60 days after identification (the 60 Day Rule), and the SRDP is one of the primary tools that providers can use to return overpayments caused by an actual or potential violation of the Stark Law. The revised protocol now requires information to be submitted on detailed Disclosure,  Physician Information, and Financial Analysis Worksheet forms, along with a Certification. A supplemental cover letter is optional.

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HIPAA / Health Privacy & Security
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California Privacy Law Poses Challenge for External Peer Review of Outpatient Psychotherapists

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

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HIPAA / Health Privacy & Security
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From the Source: Senior Advisor Provides Valuable Insight Into Office For Civil Rights’ Plans

On March 27, 2017, Rachel Yount attended the Health Care Compliance Association’s Compliance Institute 2017, where Illiana Peters, a senior advisor at Health and Human Services, Office for Civil Rights (“OCR”), provided an “OCR Enforcement Update.”

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HIPAA / Health Privacy & Security
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The Fourth Circuit Holds That The Mere Threat of Future Harm Is Insufficient to Confer Standing On Victims of a Data Breach

A recent decision from the Fourth Circuit Court of Appeals in Beck v. McDonald, 848 F.3d 262 (4th Cir. 2017), adds to the list of circuit courts of appeal that have held that that the mere threat of future harm resulting from a data breach, without more, is insufficient to satisfy the injury-in-fact requirement for Article III standing.

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Pharmaceutical & Device Compliance, Prescription Drug Pricing & Government Price Reporting, Wholesaler & Pharmacy Benefits Compliance
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Implementation and Enforcement of 340B Final Rule Delayed

In a Federal Register notice scheduled to be published on March 20, 2017, the Health Resources and Services Administration (HRSA) announced that it will delay the effective date of the January 5, 2017 final rule (the Final Rule) that provided guidance on the calculation of drug ceiling prices and the imposition of civil monetary penalties on certain drug manufacturers participating in the 340B Drug Pricing Program. Arent Fox’s Health Care Counsel Blog previously featured an analysis of the Final Rule, which can be found here

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Compliance Program Development & Counseling
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Future of Biotech: National Academies Committee Report Scans the Horizon

In a report released on March 9, 2017, a National Academies of Sciences, Engineering, and Medicine committee concluded that the bioeconomy is growing rapidly and the US regulatory system needs to provide a balanced approach to the many competing interests that will arise in the face of the expansion. The Committee also noted that regulators should be prepared for a broad array of new types of biotechnology products.

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HIPAA / Health Privacy & Security
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Regulation from Across the Pond: GDPR’s Implications for United States Health Care Organizations

What’s New?

In May 2018 - merely 14 months from now - the European Union’s (EU) General Data Protection Regulation (GDPR) will go into effect. Organizations established in the European Economic Area (EEA) are subject to the GDPR and must abide by its rules with respect to the collection, processing, and transfer of personal data. And as we explained last year, health care and other organizations not established in the EEA that collect or process European personal data (by offering goods or services to individuals in the EEA or monitoring their behavior) are also subject to the GDPR - a controversial extraterritorial reach.

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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.