In the Compliance Today article, “OIG’s revised exclusion criteria: Reducing the risk,” Arent Fox Health Care partner and leader of the DC practice Linda Baumann and Health Care associates Samuel Cohen and Hillary Stemple discuss the updated criteria that the US Department of Health and Human Services Office of Inspector General (OIG) will consider when deciding whether to exercise its permissive exclusion authority. The law gives the OIG discretion to exclude individuals or entities from participation in federal health care programs on numerous grounds, and such exclusion is often referred to as a financial “death sentence.” In addition to describing the new features in the OIG guidance, including the risk factors that the OIG is likely to consider in making the exclusion determination, the article provides guidance on steps that may help reduce the risk of exclusion.
On September 16, Arent Fox LLP hosted an interactive discussion featuring two of our health policy authorities on what the health care community can expect for the Affordable Care Act following November’s election.
What You Should Know
The hour-long conversation touched on a number of important topics. The key takeaways included:
* The following article was originally published by Healthcare Informatics. To read it on the Healthcare Informatics website, click here.
Healthcare professionals who are in a position to recommend the use of fitness apps need to be aware that patients’ personal data can be used in ways that HIPAA would prohibit and that will surprise patients who are trying to be smart about fitness in a smartphone world.
Kindred Healthcare, Inc., the country’s largest provider of post-acute care, recently paid over $3 million for violating its Corporate Integrity Agreement (CIA.) The $3 million penalty is the largest issued for a violation of a CIA to date, and is a strong reminder from the Office of the Inspector General (OIG) to the industry that CIAs are not to be ignored.
In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment in United States ex rel. Banigan v.
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.
We would be glad to discuss your particular situation. We recommend the following:
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.
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.
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.
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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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.