Antitrust Archives - HEALTH & LIFE SCIENCES NEWS

This Week in 340B: August 30 – September 6, 2023

by Emily Jane Cook and Kelsey Reinhardt | Sep 8, 2023 | 340B

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake:

The trade association appellant in a contract pharmacy case notified the court that the government appellee began enforcement of a state law that is the subject of their pending litigation.
The State of New York filed an antitrust case against a large retail pharmacy chain.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.

Top Takeaways: Permissible Provider Collaborations During COVID-19 and Beyond

by Ashley Fischer, Katharine M. O'Connor and Stephen Wu | May 21, 2020 | Health Antitrust, Health M&A

As the healthcare industry continues to cope with the Coronavirus (COVID-19) and form strategic and short- and long-term plans, providers are faced with numerous decisions that have critical antitrust implications. Whether seeking to collaborate with competitors for pandemic response or exploring potential transactional opportunities, there are both traditional antitrust guidelines and COVID-specific developments applicable to these business decisions. We discussed these important issues on our May 20 webinar. Below are top takeaways from the program. For a deeper dive into these issues, listen to our webinar recording.

Competitor collaborations

Antitrust compliance remains an important priority in the US. While companies have been engaged in finding creative solutions to COVID-19 challenges and regulators are expressing a willingness to be more flexible in interpreting and enforcing the law, the pandemic is not a carte blanche to engage in anti-competitive activity.
Regulators are more prone to accept collaborations limited in scope to respond to COVID-19 and its aftermath, and arrangements undertaken at the behest of or in partnership with government actors. Companies should avoid high-risk conduct such as direct exchanges of competitively sensitive information.
Procompetitive agreements not relating to price, wages or market/product allocations remain possible. Companies should conduct an antitrust analysis before entering new collaborations and consider whether it would be helpful or advisable to engage with federal antitrust authorities or state governments to receive feedback.

Avoiding antitrust violations in labor markets

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2019 Hospital and Health Systems Year in Review

by McDermott Will & Emery | Feb 7, 2020 | Hospitals & Health Systems

Hospitals and health systems are facing consumer demand for innovation, the need to expand and enhance streams of revenue and the push for improved quality, all while navigating changing regulations, federal enforcement, antitrust litigation and business pressures. 2019 saw hospitals and health systems navigate these challenges and more, with valuable lessons for 2020.

This Special Report presents some of the key legal actions and trends impacting hospitals, health systems and investors in the space, along with insights on how these developments will impact organizations in 2020. We address, among other topics:

2019’s transformative regulatory changes and legislation, and the legal challenges that followed
Financial distress signals, pricing strategies and contracting practices
Collaborative Transformation at work in a variety of sectors and the increase in innovation centers
Data privacy and cybersecurity challenges impacting the healthcare space

Click here to read the full report.

Anticompetitive Conduct in Biologics – An Enforcement Priority with FTC and FDA

by Lisa P. Rumin, Jon B. Dubrow and McDermott Will & Emery | Feb 5, 2020 | FDA, Life Sciences

This blog was originally published on McDermott’s Antitrust Alert Blog.

On February 4, 2020, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) released joint guidance concerning competition for biologics, including biosimilars. The joint guidance seeks to enhance competition for biologics and reduce manufacturers’ use of false or misleading statements or promotional communications concerning the efficacy or safety of biosimilars and other biologics. This guidance appears to be part of the Trump administration’s effort to reduce the cost of medications for consumers, as it is aimed at increasing the level of competition biosimilars can offer and raising awareness of the safety and efficacy of biosimilars.

The fast-growing biologics market has become an important sector of the healthcare and pharmaceutical industry. According to the joint guidance, private insurers spent over $125 billion on biologics in 2018 alone. Biologics treat many serious conditions that often lack alternative treatment options. Although Congress enacted an abbreviated FDA-approval process for biosimilars nearly a decade ago, adoption of biosimilars has been relatively slow. The FTC and the FDA will focus on competition for biologics in hopes of improving patient access to important treatment options and curbing costs. The joint guidance highlights the agencies’ efforts to transfer recent investigatory and enforcement efforts to biologics markets.

The joint guidance sets forth goals for which the FTC and the FDA will agree to collaborate in their efforts to support adoption of biosimilars and enhance competition in biologics markets. These goals build on [...]

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Three Environmental Factors Impacting the PPM Industry and Getting Deals Done

by Jerry J. Sokol | Jul 10, 2018 | Health Antitrust, Health M&A, Health Private Equity, PPM/ASC, Reimbursement

The PPM industry is by no means immune to the ebbs and flows of a traditional marketplace. Since the consolidation bubble burst in the 1990s, PPMs have gone from practically extinct to a once-again substantial component of the health care delivery system. But with greater influence comes more pressure to respond, and adapting to today’s complex operating environment requires those in the PPM industry to ensure they are building the foundational structure needed to help practices adapt to external factors and achieve long-term success.

Here are three defining aspects of today’s complex PPM environment, as well as several important considerations to help navigate environmental uncertainties and create a better patient experience.

Physician satisfaction and expectations are changing: As millennial doctors enter the workforce, they’re driving a sea change in terms of job expectations. With better work-life balance as a top priority, many young physicians are looking to be employees rather than employers, joining an existing practice instead of starting their own. Therefore, communicating what a PPM has to offer in terms of long-term incentives, rather than short-term profit margins, will be crucial to drawing in younger doctors and building a foundation that will last into the future.
Reimbursement strategies are evolving: Payer models and expectations continue to shift. Patients are being folded into a system that’s evolving from fee-for-service to value-based reimbursement models. As of now, the federal government is the biggest source of health care reimbursements in the country, but how legislative changes to reimbursement frameworks will impact [...]

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