CDR May 20th, 2024

CDR May 20th, 2024

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical PAP for Rare Disorders

According to healthcare attorneys Brian Carey , Samuel Hoff , and Ross Margulies of Foley Hoag LLP , the OIG recently issued a favorable advisory opinion for a charitable patient assistance program (PAP) focused on rare disorders, notable for its support by a single pharmaceutical manufacturer donor. This opinion, AO 24-02, carries a time limit, expiring two years after the full implementation of the Medicare Part D benefit redesign established through the Inflation Reduction Act of 2022. OIG responded favorably due to factors including the limited scope of assistance, safeguards against potential abuse, and patient eligibility criteria based on financial need rather than drug selection.

Brian Carey advises a wide range of life sciences companies and healthcare providers on federal legal, regulatory, and legislative policy matters impacting novel technologies. Samuel Hoff’s practice is focused on compliance issues and the business of healthcare, with a particular emphasis on management service and other business arrangements between clinical and non-clinical entities. Ross Margulies focuses his practice on complex Federal and state healthcare and life sciences legal and regulatory matters, with a special expertise in Medicare and Medicaid law.

Link: https://bit.ly/3wHCqBu

DOJ Releases COVID-19 Fraud Enforcement Task Force Report

Healthcare lawyers Jane T. Haviland and Abdie Santiago of the Mintz law firm recently wrote an article regarding the recently issued 2024 COVID-19 Fraud Enforcement Task Force report (CFETF). Their article highlights the CFETF’s successful prosecutions and enforcement actions in securing over $1.4 billion in seizures and forfeitures.

Proposed legislation, including a comprehensive anti-fraud proposal and bipartisan efforts to extend statutes of limitations, aims to bolster pandemic fraud investigations by providing additional resources and support to investigative agencies. Without such measures, there's concern that investigators may struggle to effectively address the growing complexity of pandemic-related fraud schemes, potentially hindering the prosecution of cases. To see their complete article, go here: ?https://bit.ly/3V8MLQc

Jane Haviland’s law practice focuses primarily on healthcare enforcement defense. Abdie Santiago represents life sciences and health care companies in a broad spectrum of regulatory, fraud and abuse, and transactional matters.

Average Starting Physician Salaries Increase by 8%

As shown in the table below, the average starting salaries in 2023 for 10 different physician specialties compared to 2022 increased, on average, 8%, per AMN Healthcare’s 2023 Review of Physician and Advanced Practitioner Recruiting Incentives report.

What Factors Affect Physician Salary?

The AMN report discusses three main factors that influence physician salary: specialty demand, geographic location, and experience level. Physicians with a higher level of experience and those with a specialty in greater demand can expect higher salaries. Physicians who practice in major metropolitan areas or rural areas can also expect higher salaries, which account for the increased cost of living and increased demand, respectively.

Future Outlook for Physician Earnings

Per AMN Healthcare, in 2024, various factors, such as telehealth trends, COVID-19's influence, and legislative shifts, are set to impact physician salaries. The integration of artificial intelligence (AI) and emphasis on value-based care may reshape compensation discussions, although direct patient care remains irreplaceable. Legislation targeting healthcare provider burnout and shortages could lead to higher compensation to retain and recruit vital medical professionals.

Link: https://bit.ly/3QSWnMD

Charles Oppenheim Talks About Latest Start Law Trends and Developments

Charles Oppenheim of the Hooper, Lundy & Bookman, P.C. healthcare law firm was interviewed by Joe Wolfe (Health Care Attorney at Hall Render) of Hall Render in AHLA’s Speaking of Health podcast. The speakers delved into key trends and interpretations of the physician self-referral law, or Stark Law, aiming to untangle its complexities. Oppenheim, a seasoned healthcare lawyer, highlights the evolution of Stark Law over the years and the necessity for frequent updates. The law's aim to prevent financial arrangements from influencing medical decisions and patient care was emphasized, highlighting the intricate process of analyzing Stark Law exceptions and regulations. The recent regulatory reforms in 2021 are noted for bringing flexibility and clarity to the law's application.

Link: https://bit.ly/3WMBZQY

Healthcare Private Equity Deal Spotlight

Rubin Pusha III , Erin Drummy , Colleen Powers , and Joseph (Joe) Kahn of Hall Render summarized the highlights of some recent PE healthcare deals:

  • WindRose Health Investors acquired SubjectWell, a Texas-based patient access marketplace linking clinical trial sponsors with patients.
  • Iron Path Capital facilitated Capital Pain Institute's acquisition of the Pain Care Surgery Center, enhancing their capabilities in advanced procedures.
  • Cardiovascular Associates of America, backed by Webster Equity Partners, acquired Atria Heart, expanding its presence with 14 physicians in Arizona.
  • Clayton, Dubilier & Rice partnered with Elevance Health to develop a joint primary care model, merging Elevance's Carelon Health division with CD&R's portfolio companies.
  • Knox Lane acquired a majority stake in All Star Healthcare Solutions, a Florida-based locum tenens staffing firm.
  • Blue Owl Capital is in talks to acquire a minority stake in Linden Capital Partners, a Chicago-based PE firm with investments across various healthcare segments.

For more details, please visit this link: https://bit.ly/44NAXq2

Kickbacks to Physicians Disguised as Rent Payments ?

The OIG recently announced a $2.5 million settlement under the False Claims Act with a diagnostic testing facility. The facility, Balance Diagnostics USA, LLC, located in Cedarhurst, New York, was found guilty of offering kickbacks to physicians and medical practices through deceptive "rent payments" to ensure patient referrals, contravening the federal Anti-Kickback Statute (AKS). For more information, please visit the link below.

https://bit.ly/3ysaFgQ

Potential Challenges Arise for Behavioral Health Deals with New State Legislation

State governments are increasingly scrutinizing healthcare dealmaking, especially in the behavioral health industry. Around a dozen states have enacted disclosure and review laws, leading to increased costs and complexities for operators in these states. These laws prolong deal timelines and require involvement from various professionals, such as attorneys and bankers, who bill based on time. The expansion of these laws emphasizes the importance of local legal expertise in navigating state-specific regulations. While some see these laws as necessary for transparency and competition, others anticipate potential legal challenges and industry pushback. Paul Gomez , co-chair of the behavioral health practice at Polsinelli , notes that investors and operators with specialized expertise or investment focus will be less dissuaded by these laws as they pursue a narrower set of assets. The proliferation of such laws may influence investment decisions, directing attention away from states with stringent regulations.

Link: https://bit.ly/3K9RICf

DOJ Introduces Task Force on Health Care Monopolies and Collusion

Catherine Behnke of King & Spalding reports that the DOJ has announced the establishment of the HCMC Task Force, a dedicated initiative that aims to address monopolies and collusion in the healthcare sector. This task force, led by Assistant Attorney General Jonathan Kanter and overseen by Katrina Rouse, is committed to lowering costs, improving quality, and enhancing accessibility for the public. The HCMC Task Force will investigate various issues, such as payer-provider consolidation, medical billing, and healthcare IT services, with the goal of holding bad actors accountable and fostering competition and innovation in the healthcare industry. Link: https://bit.ly/3wJNJt0


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