Health Law Highlights

Concurrent Call Coverage: Key Considerations for a Compliant Structure

Summary of article from VMG Health, by Holden Godat, CVA, Taylor Harville, Trent Fritzsche:

Concurrent call coverage, where a physician provides on-call services to multiple locations or specialties simultaneously, is increasingly being adopted due to a significant shortage of physicians and the growing demand for healthcare services. This approach aims to distribute work evenly and assure sufficient patient care. However, it brings about challenges in setting fair market value physician compensation, which needs to consider factors such as the burden of call, required specialty, physician availability, and sources of compensation. Each of these factors requires careful consideration to avoid overpayment and ensure regulatory compliance. Given the complexity and increased regulatory scrutiny, it is recommended to obtain third-party fair market value guidance for structuring compliant concurrent call coverage arrangements.

Health Law Highlights

“Stark” Differences: DOJ’s Renewed Focus on Stand-Alone Stark Law Violations

From Arnold & Porter, by Murad Hussain, Allison W. Shuren, Loreli (Lori) Wright:

The Department of Justice (DOJ) has recently increased enforcement of the False Claims Act (FCA) based on the Stark Law, also known as the Physician Self-Referral Law. This law focuses on financial relationships between physicians and health care entities, particularly when compensation exceeds fair market value (FMV) or varies with the volume or value of referrals. Violations of Stark Law can lead to FCA claims, requiring less proof than Anti-Kickback Statute (AKS)-based FCA claims. This trend has been evident in a series of new FCA enforcement actions and resolutions involving large health care providers since early 2023.

Health Law Highlights

Fair Market Value and Commercial Reasonableness Considerations Amid CMS Radiopharmaceutical Reimbursement Challenges

From VMG Health, by Carla Zarazua, Preston Edison, and James Tekippe, CFA:

Radiopharmaceutical drugs (RPs) are crucial for diagnosing and treating diseases. However, the current pricing structure by the Centers for Medicare and Medicaid Services (CMS) places a financial strain on hospitals and health systems and potentially restricts patient access to these vital resources. The existing CMS payment structure categorizes diagnostic RPs as supplies, bundling their cost into the overall procedure rate, causing a disconnect between the cost of acquiring RPs and the reimbursement received, particularly for high-cost drugs. 

The CMS encourages hospitals to use cost-effective resources while ensuring patient care. A temporary exception allows for separate pricing for new and high-cost drugs for two to three years, but this is a finite period. The current pricing model may force hospitals to limit the use of high-cost or newer RPs, potentially leading to suboptimal patient care and stifling innovation in drug development.

In response to these challenges, the CMS proposed five alternative payment models in 2024, including paying separately for diagnostic RPs with per-day costs above a certain threshold, restructuring the ambulatory payment classification (APC), and adopting codes that incorporate the disease state being diagnosed. Stakeholders, including the Medical Imaging & Technology Alliance (MITAS) and the American College of Radiology (ACR), advocate for separate payment for diagnostic RPs based on the average sales price (ASP) + 6% methodology.

However, the CMS has not yet decided on a new reimbursement structure for RPs, leaving hospitals to navigate the financial implications of using these drugs. To remain compliant with fair market value (FMV) and commercial reasonableness (CR), hospitals need to review and negotiate vendor agreements, document the necessity of higher-priced drugs, and establish a process for deciding which RPs to use.

In conclusion, while awaiting a resolution from the CMS, hospitals and health systems must proactively develop compliance protocols and negotiate agreements to minimize the financial impact and ensure optimal patient care. The proposed changes to the reimbursement structure for RPs represent a significant step towards addressing the economic challenges faced by healthcare providers and improving patient access to essential diagnostic and therapeutic resources.

Health Law Highlights

Inside the Healthcare Industry: The Growing Importance of Intellectual Property Valuations

From J.S. Held, by Magi Curtis, Noor Al-Banna, Greg Campanella:

Healthcare and life sciences companies are increasingly recognizing the importance of Intellectual Property (IP) in their strategic growth initiatives, investments, and licensing of data. A study by Ocean Tomo found that approximately 90% of the value of companies in the S&P 500 comes from intangible assets, such as brands, technology, patents, data, and software. This has led to two major trends in the healthcare industry.

Healthcare organizations are also becoming more thoughtful in managing their IP. They are using IP analysis not just for accessing capital, but also to provide a baseline for management to understand the incremental value generated by different strategic approaches. The rise of AI platform development technology in healthcare, life sciences, and medical device industries is another trend that is accelerating. However, healthcare organizations need to be cautious about regulatory issues around AI use and the data it’s trained on.

Data is a significant IP asset that healthcare organizations can leverage. Anonymized information and technical data related to processes, procedures, and methodologies can be licensed or sold to healthcare technology, life science, and medical device companies. This data can also be used to train AI platforms, adding further value. However, healthcare organizations need to be aware of the potential costs and dangers related to the use of this data.

Healthcare organizations need to recognize the value of their brands and negotiate license fees for their use in joint ventures and partnerships. This can be achieved by establishing a rate card, a price list for the use of an organization’s name for a specific type of service. The earnings from these license fees can be reinvested into the system, research, and more.

Health Law Highlights

How Post-Transaction Physician Compensation Structure Affects Fair Market Value of Physician Practices

From VMG Health, by Dylan Alexander, CVA and Gerrit Elzinga, CVA:

As of January 2024, there are over 338,000 physician group practices in the U.S. The compensation structure for shareholder physicians, which often changes during business transactions, plays a significant role in the valuation of a practice. Higher post-transaction physician compensation typically results in a lower valuation for the practice due to less available earnings. 

Physician compensation can take multiple forms, including salaries, benefits and payroll taxes, discretionary expenses, and other forms of compensation such as profit sharing and distributions. The compensation levels vary from practice to practice and are a vital factor in determining the earnings available for transactions.

The profitability of a practice, which influences the available compensation, is determined by factors such as physician productivity, reimbursement rates, ancillary service offerings, and effective use of mid-level providers. Expense management is also critical, as practices with high operating expenses are less profitable.

Three main valuation methods are used for physician practices: income approach, market approach, and cost approach. Both the income and market approaches are sensitive to the level and structure of physician compensation. Lower compensation levels can increase projected free cash flows and the earnings multiple, thus increasing the practice’s valuation. However, compensation should align with market levels to avoid sustainability risks.

Physician practices have the autonomy to determine their service offerings, providers, and compensation structures. Understanding the relationship between post-transaction physician compensation and the fair market value of a practice is crucial for both buyers and sellers, as it significantly impacts the practice’s valuation.

Health Law Highlights

Up and Up and Up: Accounting for Supply Cost Inflation in Due Diligence

From VMG Health, by Johnny Zizzi, CPA, and Melissa Hoelting, CPA:

  • Inflation-Adjusted Financial Analysis: In periods of high inflation, traditional financial metrics may not accurately depict a company’s performance. It is essential to adjust financial analysis for inflation, especially in the healthcare sector where supply costs have been significantly rising. Businesses must assess their ability to maintain profitability and manage costs in the face of these increases.
  • Cash to Accrual Impacts: Converting financial statements from cash to accrual accounting can significantly impact the quality of earnings, particularly when dealing with supply cost inflation. This process becomes more complex with rising costs, necessitating a financial due diligence team to ensure accurate and comprehensive analysis.
  • Robust Forecasting and Scenario Analysis: Given the uncertainties around inflation and supply chain disruptions, robust forecasting and scenario analysis are crucial for businesses to proactively manage the financial impact of rising costs. This approach can help companies adjust pricing strategies, negotiate better contracts, and implement cost-cutting measures to maintain profitability.
  • Net Working Capital Analysis: High inflation impacts a company’s balance sheet, affecting both assets and liabilities. Advisors must align the timing of cash flows associated with assets and liabilities to mitigate liquidity risks stemming from supply cost inflation. Transactions may shift towards a shorter lookback period to set the price/earnings-to-growth (PEG) in times of rising prices.
  • Conclusion: In the dynamic world of healthcare M&A, understanding historical spend normalization, cash-to-accrual conversions, and the impact of supply cost inflation is critical. The rise in inflation places a significant level of complexity on financial due diligence, highlighting the need for inflation-adjusted financial analysis, transition from cash to accrual accounting, robust forecasting, and vigilant net working capital management.
Health Law Highlights

Labs Take Note New OIG Opinion Highlights That Fair Market Value Per Test Payments Can Still Violate the Anti-Kickback Statute Publications

From Bass, Berry & Sims, by Jennifer E. Michael & Danielle M. Sloane:

  • The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, wherein the OIG reiterated its longstanding position that carving out federal health care program (FHCP) business from an arrangement does not insulate the arrangement from Anti-Kickback Statute liability.
  • The arrangement would involve laboratories that conduct both the Technical Component (TC), preparing the slides, and the Professional Component (PC), interpreting the slides.
  • The Requestor would pay fair market value (FMV) for the TC services from other labs, provide the PC, and then bill commercial insurance for both the TC and PC services. The commercial insurance policies allowed this practice.
  • The arrangement would not involve any service reimbursable by FHCP, but the Requestor did expect the labs to refer FHCP services outside of this arrangement.
  • The Requestor admitted the arrangement was not commercially reasonable because it could provide TC services itself for less than FMV.
  • Despite the FMV payment and FHCP business carve-out, OIG determined that the arrangement could increase the likelihood that the labs or their referring physicians would order federally reimbursable services from Requestor.
  • Citing its Special Fraud Alert on Laboratory Payments to Referring Physicians, OIG reiterated that the Anti-Kickback Statute is violated if even one purpose of the payment is to induce referrals of FHCP business, regardless of whether that payment is FMV.
  • Finally, the proposed arrangement in Advisory Opinion 23-06 failed to meet a safe harbor only because Requestor effectively certified that the arrangement was not commercially reasonable.
Health Law Highlights

HHS-OIG Says Anatomic Pathology Lab’s Purchased Service Arrangement Could Violate Anti-Kickback Statute

From Barnes & Thornburg, LLP, by Jason D. Schultz, Anne B. Compton-Brown, Mary Elizabeth “Lizzie” Ford:

  • U.S. Department of Health and Human Services issued an unfavorable opinion addressing an anatomic pathology laboratory that purchases services at fair market value from other labs, and bills commercial payors for such services
  • Even though the proposed arrangement carved out services reimbursed by Federal healthcare programs, the agency determined the arrangement posed a risk of fraud and abuse under the Anti-Kickback Statute
  • The opinion reiterates the HHS-OIG’s long-standing position against arrangements that “carve out” Federal healthcare program business, but still result in increased referrals of Federal healthcare program business outside of the arrangement