Health Antitrust Archives - HEALTH & LIFE SCIENCES NEWS

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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FTC to Look Closely at Competition between Biologics and Biosimilars and Patent Protection Strategies of Branded Manufacturers

by Louise Aberg and McDermott Will & Emery | Jul 24, 2018 | FDA, Health Antitrust

WHAT HAPPENED

On July 18, 2018, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb delivered a speech at The Brookings Institution in Washington, DC, discussing how to bolster competition from biosimilars while maintaining innovation.

The Commissioner noted the absence of true competition among biologics from biosimilar products in the United States, similarly to what the country experienced 30 years ago with respect to generics. The Commissioner said that this situation is caused, in part, by what he views as anticompetitive practices implemented by branded manufacturers, such as:

Rebating schemes in which drug manufacturers bundle discounts to health insurers and employers across different pharmaceutical products;
Multi-year contracts granting important rebates to payors, often entered into right before the entry of a biosimilar on the market;
Volume-based rebates;
Tying rebates, i.e., when rebates are offered if a product is bought together with a biologic;
Patent thickets, i.e., when branded manufacturers’ own dense portfolios of overlapping intellectual property rights cover biologics; and
Bundling biologics with other products, i.e., when a product is sold together with a biologic.

The Commissioner then introduced a plan (Biosimilars Action Plan) intended to apply some of the lessons learned by the FDA with respect to generic drugs to accelerate competition from biosimilars. He presented the four core action items of the Plan:

Improve the efficiency of biosimilars and of the approval process;
Maximize scientific and regulatory clarity for companies developing biosimilars;
Develop communications to improve understanding of biosimilars among [...]

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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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