HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring critical business and legal issues across the healthcare and life sciences industries
HEALTH & LIFE SCIENCES NEWS
Exploring critical business and legal issues across the healthcare and life sciences industries
Life Sciences
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Key takeaways from the Life Sciences Investment Forum 2025

by | Dec 2, 2025 | ,

On November 13, 2025, the Life Sciences Investment Forum brought together more than 180 leaders in the life sciences investment community for a day of dynamic conversations and strategic insights. Top decision-makers shared emerging trends and opportunities, how they’re navigating market headwinds, and what they expect for the industry in 2026 and beyond. Below are four takeaways from the discussions.

  1. Growth is the dominant narrative and the key valuation driver

Across biopharma, private equity (PE), and public markets, growth was repeatedly emphasized as the most important factor for valuation, fundraising, and multiple expansion.

  • Large-cap pharma has driven most recent market value expansion, fueled by demand for large-population therapies (e.g., GLP-1s).
  • Investors expect outsized returns for companies with predictable, rapid top-line growth.
  • “Keep your eye on the top line” emerged as the #1 message to investors heading into 2026.
  1. Structural headwinds are mounting: Policy, pricing pressure, and healthcare costs

Regulation – not science – will be the primary gating factor in investment decisions over the next 12 to 24 months:

  • Healthcare spending outpacing gross domestic product (GDP) is pushing pressure for cost controls.
  • Most Favored Nation (MFN) pricing, drug price negotiations, and reimbursement shifts are creating real concern for biotech P&Ls, driving the need for tight forecasting and clean data.
  • As transitions at the US Food and Drug Administration (FDA) are affecting predictability, companies must plan for worst-case regulatory scenarios and establish multiple backup plans.
  1. Early-stage is [...]

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CMS Issues FAQs to Aid Pharmacies in Preparing for Medicare Part B Coverage of PrEP Medications

by , , and | Jun 26, 2024 | , ,

As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under Medicare Part B. In response to questions from stakeholders, CMS released FAQs on June 25, 2024, to guide pharmacies through certain enrollment and billing intricacies.

Specifically, pharmacies are instructed that no new Medicare enrollment is needed if pharmacies are already enrolled in Medicare as a Part B pharmacy or a durable medical equipment, prosthetic, orthotics and supplies (DMEPOS) supplier. However, if the pharmacy is not currently enrolled in Medicare, they should consider enrolling as a Part B pharmacy rather than a DMEPOS supplier so that they are not subject to the supplier standards, accreditation and surety bond requirements.

CMS also provides pharmacies with appropriate ICD-10 CM diagnosis codes and J-codes to include with claims and instructs pharmacies that the date the drug is picked up or mailed should be entered as the date of service. Finally, recognizing that some pharmacies will fill orders for injectable PrEP to be administered by qualified practitioners, pharmacies may include a claim for the supplying fee along with a claim for the drug where appropriate. CMS anticipates that the final NCD will be posted and effective in late September 2024. The NCD is expected to be similar to the proposed NCD published on July 12, 2023.



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CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

by , , and | Apr 25, 2024 |

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS did not announce any coverage changes in the fact sheet but is providing advance information to avoid any possible disruptions to beneficiaries should the NCD be issued.

We are closely monitoring this issue and will provide further updates regarding the coverage details and additional guidance in the NCD once it is issued.

Under the proposed NCD, PrEP drugs (which may be covered under Medicare Part D and subject to beneficiary cost-sharing obligations) would be transitioned to Medicare Part B, with no beneficiary cost-sharing obligations. CMS also proposes to cover HIV screening tests and counseling visits under Medicare Part B. This would be consistent with most commercial health insurance and Medicaid plans, which, under the Affordable Care Act, must cover PrEP drugs (oral or injectable), laboratory tests and related clinical visits without cost sharing when prescribed by a healthcare provider.

If the proposed change for PrEP drugs occurs, pharmacies will need to be enrolled in Medicare Part B as either a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) supplier (CMS-855S) or as a Part B pharmacy supplier (CMS-855B). Pharmacies not already enrolled should consider doing so in preparation for the final NCD, as Part B coverage will be effective at the time the final NCD is posted. Pharmacies enrolled in Part B with the provider type [...]

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McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Hospitals and Health Systems Forum

by | Jan 13, 2022 | , ,

A series of panels co-hosted by EY and McDermott Will & Emery during the 2022 J.P. Morgan Healthcare Conference examined how hospitals and health systems continue to weather the pandemic. Leaders from the health system perspective looked at heightened cost pressures, resource strains and demands for better technology experiences, as well as innovative and collaborative responses to challenges. Policy experts spoke to the needs of providers, the antitrust landscape, and what Congress and the Biden administration might try to accomplish in the year ahead.



Below are the top takeaways for McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Hospitals and Health System Forum

Download the PDF here.

LACKING LABOR
Speaking about the current state of the pandemic, H. Mallory Caldwell, US health leader at EY, reflected on the earlier days of the pandemic. At that time, the common sentiment among health system leaders was that the arrival of a vaccine would upend the trajectory of the virus. However, availability of the vaccine hasn’t fulfilled that expectation, and the effects of COVID case waves have been reflected in health systems, specifically with increases in deferred elective procedures. Still, health services are hovering around pre-pandemic levels. The major crisis health systems are confronting is staffing. Although healthcare generally builds in a 3% wage inflation, in light of the “great resignation,” Caldwell said it is costing hospitals and health systems three [...]

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McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Life Sciences Investment Forum

by | Jan 10, 2022 | ,

Despite offering one of the lowest total deal values on record, 2021 was an active M&A year. Due to the strong capital markets, a seller’s market continued, creating additional urgency for biopharma companies to accelerate their partnership agendas, especially to access new modalities that are likely to be the cornerstone of future growth. The past year also put the MedTech industry in a position of strength. With record levels of firepower, transformational M&A is still a possibility. Yet with soaring valuations in the sector and the ready availability of capital through booming VC, IPO and SPAC markets, MedTechs, too, need a creative approach to dealmaking strategy if they are to secure future growth.

During the Life Sciences Investment Forum, two panels addressed the above topics. First, biopharma leaders discussed the current state of innovation and how companies can use dealmaking to access new products and/or technologies in 2022. Then, M&A leaders from MedTech organizations and private equity firms shared insights and best practices for their 2022 plans.

M&A FirePower: BioPharma




M&A FirePower: MedTech




Below are the top takeaways for McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Life Sciences Investment Forum

Download the PDF here.

THE INNOVATION IMPERATIVE
The explosion in new therapeutic modalities like mRNA or cell therapy is [...]

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Five Reasons You Can’t Miss HPE New York 2021

by | Sep 29, 2021 | , , , , , ,

McDermott’s signature HPE New York event is right around the corner on October 15, 2021. This year more than ever, it’s a must-attend for private equity investors, healthcare executives, lenders, consultants and leaders across the industry.

Here are the top five reasons you don’t want to miss this exclusive event:

  • To help you navigate the current market’s unprecedented deal volumes and stiff competition, we’ll equip you with the latest analysis of the hottest investment sectors and game-changing deal strategies.
  • We’ve gathered the best and brightest minds in healthcare private equity to share their real-world insights into today’s market and the trends shaping tomorrow’s opportunities. Click here to view our roster of elite speakers.
  • Early risers have an opportunity to start their day right with our bonus Big Bankers Breakfast Discussion, where leading investment bankers will examine the current state of play and the dealmaking outlook for 2022.
  • This premier event is ultra-convenient. In light of ongoing safety and logistics challenges posed by COVID-19, we’re simplifying matters by streaming this year’s event right to your personal computer or device.
  • Registration is complimentary. In response to those continued challenges around COVID-19, we’re happy to offer complimentary registration this year and hope many of you are able to join us for this timely slate of sessions.

We look forward to virtually welcoming you to HPE New York in just a couple weeks. Click here to register today.



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Investing in Global Healthcare

by , , , , , , and | Jun 10, 2021 | , , ,

Today’s global healthcare marketplace is marked by unprecedented transformation. This presents both challenges and opportunity to today’s market participants. We know how important it is to structure cross-border investments and transactions to account for complex and ever-shifting regulations.

Within this dynamic environment, our health lawyers wield a deep knowledge of how healthcare services, medical technology and pharmaceuticals are delivered around the world, and how the laws that affect those entities and that help drive action are creating the market of tomorrow.

Bringing this experience and commercial focus together we are proud to present the Global Guide to Investing in Healthcare. Our one-stop resource is here to guide you through the healthcare systems of key jurisdictions, helping you to explore the regulation and provision of healthcare services, merger and foreign investment control, anticipated changes in healthcare and life sciences law, and much more.

Click here to visit our interactive report, and start exploring the opportunities and challenges for your business today.



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Regulatory Disputes With HHS: When to Negotiate and When to Litigate

by | Apr 9, 2021 | ,

For healthcare and life sciences companies, regulatory disputes with the US Department of Health and Human Services (HHS) and its operating divisions can present significant economic and reputational risks. Efficient resolution of such disputes is always preferable and requires a thorough grasp of both the law and the institutional relationships among the relevant HHS operating divisions, other parts of the Executive Branch, and agency personnel. When a company cannot reach an efficient resolution through negotiation and litigation is the only option, the company must vindicate its rights in a principled way that mitigates reputation risks.

In this webinar, McDermott partners Brian R. Stimson and Brian J. Malkin draw on their backgrounds with HHS and the US Food and Drug Administration, respectively, to help in-house healthcare and life sciences lawyers successfully navigate regulatory disputes with HHS and its operating divisions. Read on for select highlights from this insightful discussion.

  1. The Administrative Procedure Act (APA) sets out the operating principles around which HHS is organized and gives litigators a lens through which they can assess agency efforts to implement policy. Among other things, the APA defines the parameters and procedures for bringing an action against the agency.
  2. Stakeholders generally have the best chance of successfully litigating under the APA when they can challenge an agency action as contrary to the law. “Once you veer into the agency’s deference in interpreting the law, or the agency’s deference in administering a statute, it becomes very difficult under the APA to prevail, because the [...]

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340B in 2021: What Covered Entities and Their Partners Need to Know Now

by | Mar 31, 2021 | ,

Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of Health & Human Services (HHS) and Health Resources & Services Administration (HRSA) leadership may lead to changes in 340B Program policy, but the ongoing conflicts, particularly around contract pharmacies, will not likely be resolved quickly.

In this webinar, we discussed the current issues affecting 340B Program stakeholders, the tools (and their limitations) that may be employed by stakeholders and government agencies to resolve those issues, and what covered entities can expect in future developments affecting the 340B Program.

  1. Covered entities will likely be unable to resolve contract pharmacy issues quickly through either the current litigation or the ADR panels. While there are a number of pending cases related to the 340B Program, litigation can be inherently slow process. The Administrative Dispute Resolution (ADR) Final Rule that was published in December 2020 was recently enjoined and additional injunctions may follow. While HHS appears to be moving forward with operationalizing the ADR process, the ADR Panel members who would hear the disputes remain under review by the Biden Administration. If and when the ADR panels are finally implemented, decisions of those panels may be litigated too.
  2. Covered entities should review and monitor their state Medicaid program’s billing requirements for 340B drugs. State Medicaid programs must have a mechanism to identify 340B drugs when required to exclude them from [...]

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McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health Systems: Legal and Financial Trends

by | Feb 10, 2021 | , ,

Leading professionals Gary Burke (Partner, Forensics, EY), Sandy DiVarco, and Jennifer Geetter (Partners, McDermott Will & Emery), Mike J. India (Managing Director, EY-Parthenon) and Matthew Weiss, MD (EY-Parthenon Managing Director, Health care, Ernst & Young LLP) discussed critical legal, regulatory and financial trends facing hospitals and health systems with moderator, Charlie Buck (Partner, McDermott Will & Emery).

Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System: Legal and Financial Trends, click here to access the full webinar.

Access the PDF here.

LONG TERM CHANGES TO REGULATORY RESTRICTIONS
Many regulatory requirements were relaxed in respond to the COVID-19 public health emergency. There has been much discussion regarding the extent to which these restrictions will “snap back” after the end of the public health emergency, because the public health emergency has highlighted the value of certain delivery models.
“I think there is going to be streamlining in some of these regulatory structures. So when we look at what’s going to be durable, hopefully we will see changes in the process that will make it easier for hospitals and other providers to respond and to remain on top of things,” said Sandy DiVarco, Partner, McDermott Will & Emery. [...]

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