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
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Supreme Court Declines to Adopt Automatic-Dismissal Rule for Violations of False Claims Act’s Seal Requirement

On December 6, 2016, the Supreme Court determined in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby that violation of the statutorily mandated seal requirement, 31 U.S.C. § 3730(b)(2), in a qui tam False Claims Act case does not automatically require dismissal, but instead the district court has discretion to determine the appropriate sanction under the circumstances – whether it be dismissal or a less severe sanction. See here for Arent Fox’s past coverage of the case.
 

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Affordable Care Act
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Sonja Nesbit Published in AHLA Weekly

Arent Fox’s Senior Government Relations Director Sonja Nesbit was recently published in American Health Lawyers Association (AHLA) Weekly in an article titled “The Outlook on Repealing and Replacing the ACA.” In the article, Sonja addresses the recent presidential election and the future of the Affordable Care Act (ACA).

To read the AHLA article, click here

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Anti-Kickback Statute, Office of Inspector General Developments
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New Final Regulations Provide Overdue Guidance on Permissible Arrangements Between Providers, Financial Relief for Patients

Over two years after proposing rules for comment, the Office of Inspector General for the Department of Health and Human Services (OIG) just published a final rule which revises and adds new safe harbors to the Anti-Kickback Statute (AKS) and amends the definition of “remuneration” under the Civil Monetary Penalty (CMP) rules. The change to the definition provides for exceptions to the prohibition of the offer or transfer of certain Medicare beneficiary inducements tied to their choice of provider for covered health care items or services. 

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Affordable Care Act
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AHA and FAH Send Joint Letter to Congressional Leaders on ACA Reform

On December 6, 2016, the American Hospital Association (AHA) and the Federation of American Hospitals (FAH), the two leading national hospital associations, sent a joint letter to Speaker of the House Paul Ryan and Senate Majority Leader Mitch McConnell about Congress’s approach to the ACA after President-elect Trump takes office. Both groups are essentially asking for protection from cuts in reimbursement that might take place in the process of repealing, replacing, or reforming the law. To read the joint letter, click here.

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Medicare Part D, Prescription Drug Pricing & Government Price Reporting
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The Drug Pricing Conundrum Explained

Counsel Lanhee Chen recently authored “The Drug Pricing Conundrum Explained” for RealClear Health. The article describes the recent significant discussions on drug pricing and the reality that employers, pharmacy benefit managers (PBMs), and health plans are working to ensure a competitive marketplace and hold down costs for consumers. Lanhee states that the US continues to be a center for pharmaceutical innovation and a leading source of new cures that improve human quality of life and longevity. “While some are calling for additional regulatory or legislative action to deal with drug costs, this only threatens innovation while interfering with a marketplace that is already holding down costs and ensuring broad access to the therapies and cures that Americans need,” concludes Lanhee.

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False Claims Act, Fraud & Abuse Compliance, Office of Inspector General Developments
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OIG 2017 Work Plan Lists New Enforcement Priorities
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published its Work Plan for fiscal year 2017 (2017 Work Plan), which furnishes key guidance to providers and suppliers (collectively referred to here as “providers”) and others doing business in the health care industry on the agency’s enforcement priorities for the upcoming year. Any issue that appears on the 2017 Work Plan likely will be subject to additional government scrutiny and thus creates the potential for increased exposure. As a result, providers should ensure that their compliance work plans and scheduled audit activities take into account the pertinent risk areas that have been identified by the OIG.
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False Claims Act, Pharmaceutical & Device Compliance
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US Attorney Announces Kickback and False Claims Act Settlement with Device Manufacturer BioTelmetry/MedNet

The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the company’s cardiac monitoring services.  

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Prescription Drug Pricing & Government Price Reporting
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FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements, which is available here. In this document, FDA sets forth the Agency’s expectations for parties involved in contract drug manufacturing, specifically that they delineate—in written quality agreements—each party’s roles and responsibilities to ensure compliance with FDA’s current good manufacturing practice (CGMP) requirements. The guidance applies to commercial manufacturing of human and veterinary drugs, certain combination products, biological and biotechnology products, finished products, active pharmaceutical ingredients, excipients, in-process materials and drug constituents of combination drug/device products.

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California Approves First-In-The-Nation Regulation Specifically Addressing the Threat of Workplace Violence in Healthcare Facilities

Recently, the California Division of Occupational Safety & Health Standards Board approved a new safety standard designed to provide comprehensive regulatory protections for workers exposed to workplace violence in healthcare settings. The standard, which was sponsored by several labor unions, will require covered healthcare providers to develop workplace violence prevention plans, training programs, and recordkeeping procedures to track certain incidents of workplace violence. 
 

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Prescription Drug Pricing & Government Price Reporting
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FDA Announcement on Guidance for Industry, Generic Drug User Fee Amendments of 2012

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments, available here

The revised guidance finalizes the section of the document that pertains to user fees. (Note that FDA announced GDUFA user fees for fiscal year 2017 for Abbreviated New Drug Applications, Prior Approval Supplements, Drug Master Files, and facilities earlier this year (81 Fed. Reg. 49,225, July 27, 2016).) Questions and answers related to self-identification, review of generic drug submissions, and inspections and compliance, which appeared in earlier versions of this GDUFA Q&A guidance, will be updated and addressed in a separately issued final guidance.  

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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.