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Author: Dickinson Wright

3 Dickinson Wright Attorneys Named in DBusiness Magazine’s 2018 Top Lawyers for Healthcare Law

Dickinson Wright PLLC is pleased to announce that 3 of the firm’s attorneys have been included in DBusiness Magazine’s 2018 Top Lawyers for Healthcare Law. The DBusiness Magazine’s 2018 Top Lawyers honors the leading lawyers in the Southeast Michigan region. Below is the list of Dickinson Wright attorneys named Top Lawyers: Gregory W. Moore (Member, Troy), co-chairs Dickinson Wright’s Behavioral Health Care Practice Group along with his partner Russell A. Kolsrud. Mr. Moore has been a practicing health care attorney since 1991. During his entire career, he has focused on representing and counseling providers of all types and sizes across all existing and developing segments of the industry. He has been recognized as a thought leader and innovator when it comes to the integration of behavioral and physical health care. With 25 years of experience serving clients in the industry, his practice covers the full spectrum of regulatory, transactional, and litigation services. Greg may be reached at 248-433-7268. Rose J. Willis (Member, Troy), practice focuses on healthcare regulatory, transactional and corporate law in her representation of healthcare providers and suppliers and other current or prospective participants in the healthcare industry. Rose regularly counsels healthcare industry clients on matters regarding Entity governance documents such as Bylaws, Operating Agreements, Shareholder Agreements, Buy-Sell Agreements and Deferred Compensation Agreements, HIPAA privacy and security laws, Mergers and acquisitions involving physician practices and hospitals, Stark, Anti-Kickback and other federal...

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Prescription for Fraud: Government Enforcement Activities in Compounding Pharmacies

On October 18, 2017, a Mississippi physician was charged with health care fraud for writing prescriptions for medically unnecessary compounded medications. This is the latest – though certainly not the last – example of the Department of Justice’s efforts to combat fraud within the TRICARE program. From California to Florida, federal prosecutors have charged physicians, pharmacists and sales representatives with illegal kickback schemes, health care offenses, wire fraud, Controlled Substances Act offenses and False Claims Act violations. This article provides a brief overview of the problem, examines the Government’s response, and offers suggestions for pharmacies and prescribing physicians to avoid getting caught up in these schemes. What is Compounding? Compounding is a process whereby a pharmacist or physician “combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of the individual patient.” Compounded prescriptions are not commercially available from a pharmaceutical company. Instead, they are made for the patient at the pharmacy. There are several reasons a compounded prescription may be needed. For example, a patient may need a particular strength, or perhaps a patient needs the medication in liquid form instead of a pill. At one time, nearly all prescriptions were compounded. This declined significantly with the growth of mass drug manufacturing in the 1960s. Compounding is typically expensive, as it requires time and specialized training and equipment to create the medication....

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Blessings in Disguise: Hidden Opportunities in Health Care Bankruptcies

In 2016 alone, 21 hospitals were closed across the United States because of unsustainable financial performance1, and the trend has continued with 7 additional hospitals and 18 other hospital departments closing in just the first half of 20172. Financial challenges facing many entities in the health care industry are not limited to hospitals, or even a particular geographic region. From surgery centers to family practice groups, behavioral health providers to nursing homes, rural, urban, for-profit and non-profit alike, numerous health care organizations are struggling to survive as the health care industry undergoes a metamorphic shift in economics and operations. The financial struggles of these health care organizations have continued despite a long history of industry growth far in excess of the broader rate of national economic growth. For example in 2016, spending on health care increased 6.2 percent3, while the rate of growth across all industries increased by only 1.5 percent4. While the myriad of changes to the health care industry over the past 10 years, in the form of a regulatory, financial reimbursement, technology, and patient demographics, have no doubt contributed to the challenges facing the health care industry, they do not in and of themselves, explain why, in an industry that is still growing four times faster than the rest of the economy, so many health care organizations are facing such daunting financial distress. The answer most...

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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 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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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.