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.
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.
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.
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.
In early February, the Department of Justice’s Criminal Division, Fraud Section, published a document titled, Evaluation of Corporate Compliance Programs. A must-read for any person responsible for a compliance program, regardless of industry, the document identifies common questions that DOJ may ask when making individualized determinations about a compliance program’s effectiveness. Although DOJ points out that the publication is “neither a checklist nor a formula,” the document provides practical guidance to corporations (and their attorneys) about where DOJ will focus its compliance program inquiries. And although the publication applies only to the criminal division, it may be instructive in civil fraud matters as well.
Lack of Uniform Standards May Impact Consumer and Environmental Health
For the first time in nearly three decades, the Substance Abuse and Mental Health Services Administration (SAMHSA) has updated the regulations on the confidentiality of substance abuse treatment records found in 42 C.F.R. Part 2 (the Part 2 Regulations).
Have you been wondering what OIG has done regarding drug pricing and reimbursement since 2010? Today, OIG has made it easier to find out, posting a Drug Pricing and Reimbursement Web portfolio on its website. According to an OIG announcement, the portfolio “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs. The portfolio features planned work, completed reports, industry guidance, and enforcement actions.”
Please join Arent Fox on Friday, March 10 from 8:00 AM - 1:00 PM Pacific for our annual half-day Medical Staff Leaders and the Law Conference being held at the Olympic Club in San Francisco.
About this Arent Fox Conference
This unique conference is dedicated to equipping your medical staff team with the most current skills, tools, and information to navigate challenging issues and provide effective leadership. This year’s conference will address recent legal and regulatory updates, and explore significant new laws and court decisions impacting medical staffs. We will also cover recent trends in medical staff litigation and explore the post-election impact of the new president and congress on the health care industry.
Planned Sessions Include:
Last month, Baxter International Inc. and Baxter Healthcare Corporation (collectively “Baxter”) settled a qui tam False Claims Act (FCA) case with the Department of Justice (DOJ) for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability. The government alleged that Baxter submitted false claims for a drug sold to the Department of Veterans Affairs and Department of Defense, as well as reimbursed by the Medicare and Medicaid programs, because the drug was “adulterated,” given Baxter’s alleged violations of the Federal Food, Drug, and Cosmetic Act’s (FDCA) current good manufacturing practice (cGMP) requirements – but not because of any impact on the drug itself.
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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.