Health Care Counsel

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

Health Care Counsel
False Claims Act, Federal Exchanges, Payer Disputes & Reimbursement
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Supreme Court Unlikely to Adopt Automatic-Dismissal Rule for Violations of False Claims Act’s Seal Requirement

On November 1, 2016, the Supreme Court heard argument in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby, a False Claims Act case in which the defendant sought dismissal of a qui tam action after the whistleblower violated the FCA’s seal requirement, 31 U.S.C. § 3730(b)(2), and publicly disclosed the complaint. See the oral-argument transcript here.
 
Based on the Justices’ questions at oral argument, the Supreme Court seems likely to adopt a flexible discretionary test that allows district courts to fashion appropriate sanctions for the whistleblower’s, also known as the relator, violation of the FCA’s seal requirement—rather than the bright-line “automatic dismissal” rule proposed by State Farm.
 
Procedural History
 

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Prescription Drug Pricing & Government Price Reporting
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CMS Issues Proposed Notice Announcing Changes to NDRA

Today, CMS issued a notice announcing changes that would be made to the Medicaid National Drug Rebate Agreement (NDRA). The government’s release about the changes that were published to Medicaid.gov can be found here:

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Home Health Care, Hospices and Palliative Care, Hospitals and Acute Care, Long Term Care
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The Broadening Definition of Elder Abuse

* 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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Department of Justice Developments, False Claims Act, Payer Disputes & Reimbursement, Prescription Drug Pricing & Government Price Reporting
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Mylan Agrees to $465 Million Settlement with DOJ Over EpiPen Medicaid Drug Rebate Reporting Classification
Mylan recently announced a $465 million settlement with the US Department of Justice and other government agencies regarding the company’s covered outpatient drug (COD) classification of its EpiPen (and EpiPen, Jr.),  an epinephrine auto-injector, under the Medicaid Drug Rebate Program (MDRP).  

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Office of Inspector General Developments
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Compliance Today Features Article by Arent Fox Health Care Attorneys on OIG’s Revised Exclusion Criteria

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.

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Affordable Care Act
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What the Election Means for Affordable Care Act

What Happened?
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:

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HIPAA / Health Privacy & Security
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Are Fitness Apps Fit for Privacy Protection?

* 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.

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Office of Inspector General Developments
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OIG Means It When It Says It: Kindred Healthcare, Inc. Pays Record Penalty For Violating CIA

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. 

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Office of Inspector General Developments, Prescription Drug Pricing & Government Price Reporting, Product Coverage & Payment, Wholesaler & Pharmacy Benefits Compliance
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Is the Discount Safe Harbor No Longer “Safe?”

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.

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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.