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

This Week in 340B: October 4 – 12, 2023

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: 340B Covered Entity

  • In a case involving a 340B covered entity’s termination from the 340B program, the court granted the covered entity’s temporary restraining order.
  • In a case involving the definition of “patient,” HHS filed its reply brief in support of its cross-motion for summary judgment, and an amicus curiae brief was filed.

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




Top Takeaways | Employer Market Perspective

In this session, McDermott Will & Emery Partner Patrick Healy moderated a panel that examined the expansion of value-based care in the employer market. We summarize the panel’s insights on how stakeholders can successfully implement value-based models in the employer market.

Session panelists included:

  • Mark Miller, Chief Commercial Officer, Wildflower Health
  • Simeon Niles, Vice President of Health Care Innovation, Morgan Health
  • Carl Landry III, Director, Healthcare Strategy, Guidehouse

Top takeaways included:

  1. Motivated by the unsustainable increase in healthcare spending and new consolidation and joint ventures among providers and health insurers, there is an accelerated need for solutions in the employer market. If the employer market does not self-regulate, the market fears that regulators will step in.
  2. Regarding the relationship between employers with self-funded plans and third-party administrators (especially those owned by health insurers), there is confidence that third-party administrators’ historical relationships with employers will generate more turnkey programs producing easier-to-integrate value-based care models.
  3. There is a particular emphasis on how smaller employers will utilize employee data and implement value-based care models in comparison to jumbo employers.
  4. Significant interest in the jumbo-employer market is met with limited adoption and penetration of value-based care models when compared to the Medicare/Medicaid space. It is unclear whether these challenges are due to structural issues in the employer market limiting the pace of adoption. Such structural issues include employers as individual purchasers of coverage (as opposed to aggregate bulk purchasers); associated pools of covered lives too small for providers to take risk; [...]

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This Week in 340B: September 27 – October 3, 2023

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: 340B Covered Entity

  • The Ninth Circuit granted the prime vendor program appellee’s request for an extension to file its appellee brief.
  • A 340B Covered Entity filed suit against HHS, alleging it was improperly removed from the 340B Program.
  • Defendants in a qui tam action filed a Motion to Dismiss, which will be heard by the District Court for the Central District of California in December 2023.
  • The plaintiff in a case aiming to invalidate a state law governing contract pharmacy arrangements filed a First Amended Complaint.

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




HHS, DOL and Treasury Issue a Proposed Rule Increasing Federal IDR Fees

On September 20, 2023, the US Departments of Health and Human Services (HHS), Labor (DOL) and the Treasury (collectively, the departments) issued a proposed rule related to the No Surprises Act’s (NSA’s) federal independent dispute resolution (IDR) process. The proposed rule would amend existing regulations to provide that the two fees associated with the IDR process—the administrative fee amount charged by the departments, and the ranges for the IDR entity fees for single and batched determinations—be established by the departments through notice and comment rulemaking. The proposed rule outlines the methodology for calculating the fees and proposes the fees/fee ranges for disputes initiated on or after January 1, 2024. The proposal comes in response to a court order in the recent Texas Medical Association (TMA IV) case, which requires the departments to establish such fees through formal rulemaking.

IN DEPTH

ADMINISTRATIVE FEE TO INCREASE TO $150

The NSA’s nonrefundable IDR administrative fee is paid by both parties to cover the cost of their participation in the IDR process. For 2022, the administrative fee was $50 per party. The fee was expected to remain the same for 2023. However, in December 2022, the departments issued revised guidance increasing the fee from $50 to $350 for 2023. Plaintiffs in TMA IV challenged the increase as being unlawfully issued via guidance. The US District Court for the Eastern District of Texas agreed and vacated the portion of the guidance that increased the fee.

In light of the court’s order, the [...]

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Top Takeaways | PPM, ASC and Health System Collaborations and Innovation

In this moderated session, panelists discuss how physician practice management companies (PPMs), ambulatory surgery centers (ASCs) and health systems are both competing and collaborating in the evolving healthcare environment.

Session panelists included:

  • Lexa Heinz, Vice President, Iron Path Capital
  • Chris Kehres, Chief Growth Officer, executive vice president of finance, GI Alliance
  • Andy McCawley, Chief Development Officer, United Surgery Partners International
  • Gary Ruff, Vice President, Ambulatory Surgery Centers, CHRISTUS Health
  • Moderator: Jay Greathouse, Partner, McDermott Will & Emery

Top takeaways included:

  1. Physicians are looking for three key items: (1) partnerships with ASC operators or health systems that can bring higher and/or better rates, (2) assistance with recruitment that ensures older physicians will get their buyout at retirement and younger physicians are not saddled with operations or debt of a center, and (3) management responsibility for ensuring that centers are operating efficiently.
  2. Since the COVID-19 pandemic, health system partners are being more proactive versus reactive to volume leaving a hospital setting. For example, more health system partners are willing to have employed physicians invest in its surgery centers and are using it as a recruitment and retention tool for employed physicians.
  3. Physician consolidation is helpful because it creates more value in the form of higher rates or ancillaries, which are income drivers, and assists with recruitment. Physician consolidation also is helpful in expanding geographic footprints, as a larger practice may be present in multiple markets.
  4. Certificate of need (CON) requirements are a big challenge to bringing health systems into [...]

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