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Author: Dickinson Wright

Department of Justice use of Parallel Proceedings

By: Kerry Harvey  Corporations and individuals engaged in a heavily regulated industry, particularly those doing business with the federal government, stand a good chance of being called upon to provide information related to a government investigation. Healthcare providers, government contractors and financial institutions immediately come to mind. The initial contact may come in a number of forms; a visit from an agent, a call from an Assistant United States Attorney (”AUSA”) or something more formal such as a Civil Investigative Demand, an administrative subpoena, or, more ominously, a grand jury subpoena. Regardless of the form, the inquiry is likely more than a fishing expedition. By the time the government makes contact, its representatives have a fixed purpose and know a great deal about the subject of the inquiry. The government may inform the subject, through one means or another, that the inquiries are related to a civil or administrative matter. If so, the subject may very well breathe a sigh of relief thinking, “At least it’s not criminal.” This may well be a false sense of security. Indeed, one should assume at least the possibility of a criminal investigation until there is conclusive evidence to the contrary. The proper response to a potential criminal investigation differs significantly from that to a matter entirely civil in nature. Failure to recognize the possibility of a concurrent criminal investigation can lead to...

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Keeping Pace in Clinical Research: The Common Rule Picks up Speed

By: Billee Lightvoet Ward, Esq. Of Counsel, Grand Rapids Office Phone:  616.336.1008 bward@dickinsonwright.com In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the technology employed to conduct the research and the nature of the research itself. As one example, increasing reliance on repositories of human biospecimens or individually identifiable health information has changed the research landscape and the associated risks and benefits. Until recently, applicable federal regulations have failed to keep pace. The Common Rule Despite the expansion and modernization of clinical research, the principle federal regulations governing protection of human subjects and ethical conduct in federally supported clinical research (the Federal Policy for the Protection of Human Subjects, generally known as the “Common Rule”), have remained largely unchanged since they went into effect in 1991. However, on September 8, 2015, sixteen federal agencies issued a Notice of Proposed Rulemaking (the “NPRM”) with the intent of clarifying the regulations and making them less burdensome on the research community while maintaining protections for clinical trial participants. The NPRM was in follow-up to an Advance Notice of Proposed Rulemaking issued in 2011 which solicited public comment on the notion of updating the Common Rule. On January 19, 2017, after fielding over 2100...

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Recent Case Serves as Reminder to Take Care in Structuring Sales of Physician Practices

By: Ralph Levy Of Counsel, Nashville Office Phone:  615.620.1733 rlevy@dickinsonwright.com Over the past few years, hospitals, health systems and practice management companies have increased their efforts to acquire physician practices. Moreover, physician groups are increasingly interested in selling their practices to these interested purchasers. The primary reasons for this trend are varied but in general are prompted by an increased focus on the delivery of medicine in a seamless integrated system by all healthcare providers. For physicians or other healthcare providers that are considering practice sales, care should be taken in structuring the sale to minimize the federal taxes payable as a result of the sale. In general, there are two choices to structure the practice sale: Stock sale – Under this sale structure, which works only if the practice is incorporated, the physicians sell stock in their professional corporation or professional association to the interested purchaser Asset sale – Under this sale method, the practice itself sells its tangible and intangible assets to the purchaser In addition to these two choices, the sale can be structured as a hybrid using a combination of these sales methods. A final and much less common option would be for a portion of the sale consideration to be paid by the purchaser to one or more selling physicians and characterized as a sale of personal goodwill. For both tax and non-tax reasons,...

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High Court Unanimously Upholds ERISA Exemption For Church-Affiliated Pension Plans

By: Kimberly J. Ruppel Member, Troy Office Phone:  248.433.7291 kruppel@dickinsonwright.com Advocate Health Care Network et al v. Stapleton et al, 581 U.S. __ (2017) In one of the recent opinions rendered by the United States Supreme Court, it was found that pension plans maintained by religiously affiliated pension plan committees were exempt from certain provisions of the Employee Retirement Income Security Act of 1974, 29 U.S.C. § 1001, et seq. (as amended) (“ERISA”). Why is this of interest? ERISA obligates employers to follow a set of rules designed to ensure plan solvency and protect plan participants. Some of these rules, particularly rules regarding pension plan design and funding, may seem more burdensome to employers than protective of employees. The outcome of this case was a blow to those seeking to hold church affiliated hospitals accountable to the same ERISA requirements as their secular counterparts. The original ERISA statute provided an exemption for “church plans”, defined as “a plan established and maintained . . . for its employees . . . by a church.” 29 U.S.C. §1002(33)(A). Congress amended the statute in 1980 in part to add a section that formed the basis of the dispute before the Court as follows: “A plan established and maintained . . . by a church . . . includes a plan maintained by an organization . . the principal purpose . . ....

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Where is your PHI Data Traveling Today?

By: Craig A. Phillips Member, Grand Rapids Office Phone: 616.336.1030email: cphillips@dickinsonwright.com With most vendors offering and pushing cloud computing solutions and offsite data backup, or guaranteeing offsite backup of data they process for you, many HIPAA covered entities and business associates are questioning whether and how they can take advantage of cloud computing while complying with regulations protecting the privacy and security of electronic protected health information. At the same time, the rise of offshore IT services, including distributed storage, by cloud data providers creates issues that most healthcare providers have not yet realized. Even if some of the issues are realized, many covered entities and their business associates do not know where their data is currently being processed, stored, or backed up. In fact, storage or processing of personal health information (“PHI”) overseas may or may not be permitted or at least require additional resources, such as additional or more detailed risk assessments. There currently are no federal regulations or statutes that prevent storing or processing PHI offshore or overseas; however, the Centers for Medicare and Medicaid Services (“CMS”), the U.S. Department of Health and Human Services (“HHS”), and the U.S. Office of Civil Rights (“OCR”) within the HHS, have all issued regulations or provided guidance that restrict storing or processing PHI offshore. In addition, there are four states that ban any Medicaid data from being stored or processed...

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Disclaimer

The Health Law Blog is published by Dickinson Wright PLLC to inform the public of important developments within the firm and practice areas. The content is informational only and does not constitute legal or professional advice. We encourage you to consult a Dickinson Wright attorney if you have specific questions or concerns relating to any of the topics covered in this blog.

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