Health Care Counsel

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

Health Care Counsel
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The New Partnership Audit Rules—When to Amend Your Partnership or LLC Agreement

The new partnership tax audit rules enacted by Congress on November 2, 2015 could have a dramatic impact on partnerships and their partners (including limited liability companies taxed as partnerships (“LLCs”) and their members). The new rules will apply to audits of tax returns for tax years beginning after December 31, 2017.
 
The “tax matters partner” provision found in virtually all partnership and LLC operating agreements will not work for tax years when the new partnership audit rules will automatically apply. Thus, this provision will have to be amended at some point. The only question is when.  Partnerships and LLCs should not wait until the commencement of an audit to amend their partnership or operating agreements.

Executive Summary
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Pharmaceutical & Device Compliance
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Sellers Beware: California Adopts New Proposition 65 Warning Requirements

On August 31, 2016, California took a long-awaited step in publishing new major changes to the Proposition 65 warning regulations; the first of such amendments in more than a decade. The wholesale changes completely alter the “safe harbor” warning rules, creating a new set of obstacles for companies offering products or operating facilities in California. Although the new regulations are intended to increase clarity and decrease litigation, they may actually have the opposite effect. 
 

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Anti-Kickback Statute, Stark Law
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Strafford Live CLE Webinar: OIG and CMS Voluntary Self Disclosures – Weighing the Risks and Rewards of Self Reporting

Please join Arent Fox associate Sam Cohen on Thursday, September 15, from 1:00-2:30 PM Eastern for a Strafford live CLE webinar titled OIG and CMS Voluntary Self Disclosures: Weighing the Risks and Rewards of Self Reporting.

About this CLE Webinar
Counsel to health care providers must understand the potential tools for resolving Stark law or Anti-Kickback Statute violations. The options have never been so varied as they are now, with each pathway presenting its own advantages and disadvantages. There is also the challenge of navigating these pathways and their peculiar requirements and measures. This webinar will provide guidance to health care counsel on the OIG’s SDP and settlements under CMS’ SRDP. The webinar will also outline guidance for evaluating the risks and rewards of disclosing potential violations.

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Pharmaceutical & Device Compliance, Prescription Drug Pricing & Government Price Reporting
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Vermont Publishes First List of Pharmaceuticals for Transparency Reporting

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports. The list is available on the Vermont Office of Attorney General website. Prescribed forms are available for reporting there as well. Reports are due on or before October 1, 2016.

To download the Drug List Per Act 165, click here.

To download the Drug Manufacturer Instructions, click here.

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Anti-Kickback Statute, False Claims Act, HIPAA / Health Privacy & Security, Stark Law
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Needing to Adjust: DOJ and HHS Announce Steep Increases to FCA, Stark Law, Anti-Kickback Statute, and EMTALA Penalties

Life science companies, health care providers, and government contractors will be at risk for significantly larger penalties due to substantial increases to False Claims Act (FCA) penalties and civil monetary penalties (CMPs). These penalty increases cover a broad range of health care violations, including the Stark Law, the Anti-Kickback Statute, the Emergency Medical Treatment and Labor Act (EMTALA) and the Health Insurance Portability and Accountability Act (HIPAA). The Department of Justice (DOJ) and the Department of Health and Human Services (HHS) recently announced these “adjustments” to account for inflation – in one case, accounting for more than 40 years of inflation. In particular, the new FCA penalties are nearly double, and CMPs for both the Stark Law and the Anti-Kickback Statute have increased approximately fifty percent.

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False Claims Act
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AHLA Educational Call: Implications of Escobar - Credentialing and Peer Review Compliance Issues and Risks

Please join Arent Fox partner Erin Muellenberg on Friday, September 16, from 1:30-2:30 PM Eastern for an AHLA educational call on the Implications of Escobar: Credentialing and Peer Review Compliance Issues and Risks. 

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HIPAA / Health Privacy & Security
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2016 Survey of Data Breach Notification Statutes

Every state and territory in the US, except Alabama, New Mexico, and South Dakota, have data breach notification statutes, and most of them apply to any person, business, or government agency that acquires, owns, or licenses computerized data that includes personal identifiable information of individuals who reside within that jurisdiction.

This survey focuses on the data breach notification statutes of the states and territories within the US, and should be a useful tool and guide for data security planning and response purposes.

To view and download the full survey, click here
 

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It’s About Time: The California Board of Registered Nursing Proposes the First Updates to Nurse Practitioner Regulations in 30 Years

Earlier this month, the California Board of Registered Nursing (BRN) proposed significant changes to regulations affecting nurse practitioners (NP) practicing in the state. Although the changes do not affect the NP scope of practice, they do reflect an attempt to modernize the BRN’s regulatory approach toward NP certification. The public may send written comments on the proposed changes to the BRN by September 19, 2016. The BRN also will hold a public hearing on the proposed amendments on September 19, 2016, at 9:00 a.m., in Sacramento. 

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Affordable Care Act
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New Dispute Resolution Process Finally Proposed for 340B Program: Abundant Opportunity for Comment by Stakeholders

On August 12, 2016, the Health Resources and Services Administration published a proposed rule setting forth the requirements and procedures of the administrative dispute resolution process applicable to all covered entities and drug manufacturers participating in the 340B Drug Pricing Program. Comments on the Proposed Rule are due on or before October 11, 2016.
 

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Affordable Care Act
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EVENT: The Future of the Affordable Care Act After the 2016 Elections

Please join Arent Fox LLP on Friday, September 16th, for an engaging program where Arent Fox counsel Lanhee Chen and senior government relations director Sonja Nesbit will discuss the fate of the Affordable Care Act given the current political environment and the upcoming presidential election. This will be an interactive discussion between our two health policy authorities who will present different ideas and perspectives on the future of this important and oft-debated piece of legislation.

About the Panel

Lanhee Chen

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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.