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Is your cybersecurity upgrade FDA reportable?

In today’s marketplace, technology evolves at a rapid rate, and must adapt to changing circumstances, such as threats to cybersecurity. For device companies, some types of modifications to devices post-market - potentially...more

Deal Watch: Teva and Regeneron Announce Fasinumab Collaboration

On September 20, Teva Pharmaceutical Industries Ltd. and Regeneron Pharmaceuticals, Inc. announced an agreement to develop and commercialize fasinumab, an investigational NGF antibody currently under development by Regeneron...more

DOJ and States Challenge Health Insurer Mergers

Following more than a year of regulatory review, in late July 2016 the Department of Justice (DOJ) Antitrust Division and a number of states filed actions seeking to derail both the Anthem/Cigna and Aetna/Humana mergers. In...more

Dismissing Lawsuits Against Owners of New York Nursing Homes

There are many state and federal statutes which provide personal liability against the owners of businesses that are operated through corporate or other legal forms such as Limited Liability Company’s (“LLC’s”). One such...more

Managing the Transition to Transformation: Corporate Governance and the Transition to Transformation

McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...more

Also In The News - Health Headlines - August 2016 #4

CMS Reports ACO Savings and Improved Quality of Care – CMS issued a press release on August 25, 2016 announcing the 2015 performance year results for the Medicare Shared Savings Program and the Pioneer Accountable Care...more

Healthcare & Life Sciences Private Equity Deal Tracker: Frazier Healthcare Partners to Acquire Matrix Medical Network

Frazier Healthcare Partners will acquire a majority equity interest in Matrix Medical Network, according to a press release. Following completion of the transaction, Frazier will own a 60% equity interest, with The...more

Government Investigations - How to Respond to a Search Warrant: 10 Practical Steps

In a highly regulated industry such as health care, it’s not uncommon to be the subject of a government investigation. In-house counsel and leadership must be prepared in advance for the possibility of a search warrant being...more

Maximizing value in today's brisk healthcare M&A market

A rare confluence of factors is generating great opportunities for private equity and strategic buyers in the healthcare industry. These factors have buyers lining up at the gate, resulting in unprecedented (and often double digit) multiples and enterprise valuations, which have positioned physicians and other healthcare entrepreneurs to reap significant financial rewards.more

Increase in Funding to Med Device Startups

Despite a drop in the second quarter of 2016, medical device funding is expected to finish stronger this year than in 2015. CB Insights has released a report on the funding and deal activity within the medical device industry since 2012. CB Insights reports that “after hitting a 4-year high of $1.5 billion in the second quarter of 2014, funding to medical device startups has sobered considerably.” Funding in 2014 was elevated by a $172 million Series G round secured by California based Proteus Digital Health. Overall, the medical device industry is on track for a modest increase in deals and dollars to private companies in 2016, after seeing a decline in both in 2015.more

Finally A Clear Ruling On A Much Needed Bankruptcy Preference Defense

The United States Bankruptcy Court for the District of Delaware has finally clarified that the administrative expense claim for goods delivered post-bankruptcy filing may be set off – dollar for dollar – to reduce any open preference exposure. The decision provides the first written decision from Delaware providing authority for preference defendants with post-bankruptcy filing administrative expense claims to apply these expense claims, dollar for dollar, against any preference liability they may incur.more

Managing the Transition to Transformation: Provider/Payor Integration: 2016 Is Not the 1990s

McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery models. The goal of this series is to help organizations prepare so that they are not only competitive, but can also thrive under alternative payment models (APMs) and quality-based reimbursement models (QBRs). This article discusses the trends and considerations driving many health systems to consider developing or acquiring a provider sponsored health plans. more

Ninth Circuit: Manipulation of Risk Adjustment Data Subjects Insurers to False Claims Act Liability

The U.S. Court of Appeals for the Ninth Circuit has revived a whistleblower suit against Aetna, UnitedHealthcare and WellPoint for allegedly submitting false data for Medicare Advantage payments. Some of the nation’s largest health insurers must face a False Claims Act (FCA) suit accusing them of turning a blind eye to improper diagnoses. The unanimous Ninth Circuit opinion reversed a lower court decision to dismiss the suit.more

GSK and Verily Partnering to Form New Bioelectronic Medicine Firm

GlaxoSmithKline (GSK) announced that it is partnering with Verily Life Sciences LLC to form Galvani Bioelectronics. According to the press release, GSK and Verily will contribute IP rights and an investment of $712.7 million over seven years.more

August Antitrust Bulletin

Activist Investor Settles DOJ Premerger Notification Case for Record $11 Million - On July 12, 2016, the U.S. Department of Justice (DOJ) announced that it had reached a settlement in its landmark lawsuit against activist investor ValueAct. As previously reported, the DOJ’s complaint accused ValueAct of improperly relying on the “investment-only” exemption to the Hart-Scott-Rodino Act’s reporting requirements when it failed to report certain acquisitions of securities in connection with a proposed merger between two oilfield services companies.more

Intellectual Property in Medicine: Tailoring your Patent Strategy

In last week’s post, we covered initial considerations for physicians considering patent protection. At this point, you may be wondering why we haven’t talked about the actual patent application process. That’s because it is critical to have your overall patent strategy in place even before you file your first patent application, and that strategy must fit with your business plans. Originally published in Minnesota Physician - March, 2016.more

Chicago Pacific Founders Closes Inaugural Fund at $325 Million

Chicago Pacific Founders has announced it has closed its debut fund. The fund was oversubscribed at its $325 million hard cap.more

New N. Calif. Report Suggests High Cost of Giving Birth Linked to Increased Health System Consolidation

Childbirth is the leading indication for hospital admission in California, with roughly 500,000 deliveries in the state each year. This is particularly challenging for health plans serving Northern California, the most expensive region in the country to give birth. New research suggests that increased health system consolidation may be a factor contributing to high prices, and sheds light on considerable regional differences in costs of delivery across the US.more

Healthcare Newsletter: Volume 6, Number 1

Recent Developments in Mental Health Benefit Denials - The Mental Health Parity and Addiction Equity Act (Parity Act) requires health plans to provide the same coverage for mental health conditions as they provide for physical conditions, and that financial requirements and treatment limitations applicable to mental health and substance use disorder benefits be no more restrictive than those that apply to medical and surgical benefits. more

DOJ Seeks to Block Two Major Health Insurance Mergers

The United States Department of Justice (DOJ) is suing to block two proposed mergers between major health insurance companies, claiming that the deals violate antitrust laws and would lead to increased health care costs for patients. As noted in an earlier blog post, the merger of Aetna and Humana, as well as Anthem Inc.’s acquisition of Cigna Corp., has faced many regulatory and antitrust hurdles since being announced last year. Several key stakeholders, including California insurance Commissioner Dave Jones, have expressed concern that the aforementioned mega-deals will result in an anti-competitive insurance market. Now, the DOJ has announced that it is challenging both mergers on the grounds that they "would lead to higher health-insurance prices, reduced benefits, less innovation, and worse service for over a million Americans."more

Healthcare & Life Sciences Private Equity Deal Tracker: Warburg Pincus to Acquire Stake in Hygenia

Warburg Pincus has announced it will invest in Hygenia. Warburg Pincus, headquartered in New York, is a PE firm that takes a long-term perspective and invest in businesses at all stages of development. It invests healthcare and several other sectors.more

IRS Denial of Accountable Care Organizations Raises More Questions Than It Answers

In a recent ruling, PLR 201615022, the IRS denied tax exemption to an accountable care organization on the basis that the organization was conferring private benefit on its participating physicians by negotiating shared savings arrangements with private health insurers. The denial has some tax-exempt hospitals concerned about whether their participation in certain ACOs might jeopardize their tax exemption or result in unrelated business income tax. We do not believe such a pessimistic interpretation is warranted for at least three reasons. First, neither the facts of the case nor the analysis is presented in sufficient detail to discern exactly what position the IRS is taking in the denial ruling. Second, the governing law and prior IRS guidance support the argument that an ACO with substantial shared savings arrangements with private insurers may qualify for exempt status under the right circumstances. Third, even if an ACO does not qualify for exempt status because of substantial shared savings arrangements with private insurers, a tax-exempt hospital’s participation in such an ACO will not necessarily jeopardize its exemption or result in UBIT.more

Healthcare & Life Sciences Private Equity Deal Tracker: Thoma Bravo to Acquire Healthcare IT Security Company Imprivata for $544 million

Thoma Bravo has announced it will acquire Imprivata for approximately $544 million. Thoma Bravo, with offices in Chicago and San Francisco, is a PE firm that invests with a particular focus on application and infrastructure software and technology-enabled services.more

FCPA Compliance and Ethics Report-Episode 266, Ben Locwin on people v. systems approach to compliance programs

In this episode, I visit with Ben Locwin on the different approaches in compliance around people v. systems. more

When May Antitrust Not Stop a Health Care Combination? When a Court Decides other Federal Law May Compel It.

[The Court’s] determination reflects the healthcare world as it is, and not as the FTC wishes it to be. We find it no small irony that the same federal government under which the FTC operates has created a climate that virtually compels institutions to seek alliances such as the Hospitals intend here. Like the corner store, the community medical center is a charming but increasingly antiquated concept. It is better for the people they treat that such hospitals unite and survive rather than remain divided and wither.more

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