Healthcare Regulatory & Compliance Summit 2026 Recap

Firm Publication

Bass, Berry & Sims hosted its second annual Healthcare Regulatory & Compliance Summit on March 4. Our attorneys were joined by panelists from Wayspring, Dartmouth Health, FHP Strategies, Pinnacle Healthcare Consulting, HAP, and Mosaic Health.

The Summit welcomed in-house counsel, compliance officers, and C-suite executives from across the healthcare industry to the firm’s office at Nashville Yards.

The Healthcare Regulatory Year in Review

Anna Grizzle and Travis Lloyd, Members at Bass, Berry & Sims, provided a comprehensive overview of the significant regulatory shifts affecting the healthcare industry over the past year. Against the backdrop of the new administration’s policy priorities—including the Make America Healthy Again (MAHA) initiative, vaccine policy reforms, gender affirming care restrictions, Medicaid cuts under the One Big Beautiful Bill Act (OBBBA), and substantial federal workforce reductions—the session examined four key areas of regulatory development that demand the attention of healthcare stakeholders. These included the Rural Health Transformation Program, new Centers for Medicare & Medicaid Services (CMS) fraud and abuse initiatives, key payment rule updates, and healthcare fraud enforcement.

The Rural Health Transformation Program, established under OBBBA, represents a substantial $50 billion investment over five years aimed at improving care and health outcomes in rural communities. The program allocates funding to states based on both approval of a request for funding and factors such as ruralness, state policies, and application quality, with strategic goals spanning MAHA, sustainable access, workforce development, innovative care, and technology innovation. Following an aggressive timeline with applications opening in September 2025 and awards granted in December 2025, Texas and Alaska emerged as the largest funding recipients—Texas for its rural telehealth and artificial intelligence (AI) initiatives and Alaska for its transition to a value-based payment model. CMS monitoring of these programs commenced in the first quarter of 2026.

On the fraud and abuse front, CMS has adopted an increasingly aggressive posture, shifting its approach from “pay and chase” to “prevent and detect” through initiatives such as the Wasteful and Inappropriate Service Reduction (WISeR) model, which requires prior authorization for 17 service categories susceptible to fraud and utilizes private sector AI partners across six pilot states. CMS has also announced plans to accelerate Risk Adjustment Data Validation (RADV) audits for plan years 2018 through 2024; and has implemented a nationwide moratorium on Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) enrollment and launched the Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative seeking stakeholder input on fraud prevention strategies. Regarding payment rules, notable updates include expansion of the ambulatory surgery center (ASC) covered procedures list, a three-year phase-out of the inpatient-only list beginning in calendar year 2026, permanent adoption of virtual direct supervision, and significant changes to skin substitute reimbursement methodology. The session also highlighted ongoing site-neutral payment developments and new provider-based attestation requirements under the Consolidated Appropriations Act of 2026.

Healthcare fraud enforcement reached record levels in fiscal year 2025, with $6.9 billion in civil fraud recoveries—83% of which stemmed from healthcare matters. The renewed Department of Justice (DOJ)-Department of Health and Human Services (HHS) False Claims Act (FCA) Working Group has prioritized Medicare Advantage and pharmaceutical enforcement, while criminal actions have targeted telemedicine fraud, opioid prescribing schemes, and wound care abuses, resulting in $14.7 billion in identified false claims and charges against 324 defendants across 50 federal districts. Given the particular focus on skin substitutes, wound care providers should prioritize compliance in this area and ensure all documentation meets requirements. The session noted significant legal developments, including the constitutional challenge to FCA qui tam provisions in Zafirov v. Florida Medical Associates, which, if upheld, would potentially change the landscape of fraud and abuse enforcement, as well as new compliance guidance, including the first Medicare Advantage-specific compliance program guidance in over 26 years.

The speakers concluded by emphasizing that while new administration priorities have emerged, traditional enforcement areas remain a focus, and stakeholders should expect sustained attention on Medicare Advantage, site-neutral payment policies, and price transparency initiatives.

Tips & Tricks in Evaluating and Implementing Value-Based Care Arrangements

Danielle Sloane, Member at Bass Berry & Sims, and Alice Heywood, Chief Legal Officer at Wayspring, presented on the evolving healthcare landscape and value-based care arrangements under the current administration’s initiatives. The presentation was based on their upcoming content to be released in the Health Law Handbook, 2026 Edition.

Danielle and Alice talked about how the OIG’s finalized rules helped to modernize the Stark Law, Anti-Kickback Statute, and Civil Monetary Penalties Law as part of HHS’s “regulatory sprint to coordinated care,” aiming to enable value-based care, improve technology infrastructure, and encourage innovation. Despite political changes, momentum toward value-based care has continued, with CMS maintaining its goal of placing all Medicare beneficiaries in value-based arrangements by 2030. Recent federal initiatives—including the Trump administration’s “MAHA” agenda and new CMS Innovation Center strategies—reinforce a long-term commitment to prevention, wellness, reduced acute care use, and greater care coordination.

Value-based care has also expanded across commercial markets. While Medicare Advantage continues to lead, commercial risk-based models surpassed Medicaid in 2023, driven by employer interest and payer investment. Major insurers and health systems are increasingly participating through direct investments, partnerships, or launching their own health plans, signaling that value-based care is becoming a standard feature of the healthcare landscape.

For providers, success in value-based care requires improving outcomes while managing costs, negotiating complex payer agreements, and making upfront investments in technology, data analytics, and care coordination. Many organizations now have greater experience and comfort with these models, and even those that previously hesitated are entering the space—either by choice or mandate—making readiness to evaluate and negotiate value-based arrangements essential for most healthcare stakeholders.

To read the full content Danielle and Alice provided for the Health Law Handbook, 2026 Edition, click here.

Hot Topics in Academic Medical Centers

Audrey Wilson, Deputy General Counsel at Dartmouth Health, and Scott Shanker and Audrey Anderson, Member and Counsel at Bass, Berry & Sims, respectively, provided an overview of the significant regulatory challenges impacting academic medical centers (AMCs). The speakers offered their thoughts on how to navigate the especially complex healthcare regulatory landscape in which AMCs operate, with special focus on AMCs’ increased involvement in hospital acquisitions and physician alignment.

The panelists discussed the factors that separate AMCs from other healthcare provider systems, and how there is inconsistency under federal and state laws in even defining the terms “academic medical center” or “faculty practice plan,” resulting in reliance on the academic medical Center exception under the Stark Law. Throughout the presentation, the speakers emphasized the uniqueness of AMCs, emphasizing varying governance structures, academic missions, and medical innovation, while balancing teaching, clinical and research performed by AMC physicians.

The speakers discussed regulatory considerations relating to physician compensation, with federal healthcare fraud and abuse laws in general, and the Stark Law in particular, being of note. The speakers touched on the importance of a fair market value (FMV) payment to physicians that does not take into account the volume or value of referrals (or other business generated). In determining FMV, credible valuation data needs to be memorialized and ongoing monitoring of compensation is necessary to ensure compliance. The speakers also discussed joint ventures at AMCs, along with the strategic rationale driving these types of arrangements. The speakers analyzed potential issues relating to board representation, voting rights, reserved powers, physician clinical committees, financial risk, and joint research outcomes and publications.

Research and grant compliance at AMCs is a hot button topic, as this area requires significant financial commitment and compliance with scientific and ethical standards. In this part of the presentation, the speakers described this highly complex regulatory environment, which intersects with a multitude of legal issues including the Common Rule and human subject protections, Food and Drug Administration (FDA) regulations for clinical trials, Institutional Review Board (IRB) approvals, National Institutes of Health (NIH) grant applications, and healthcare fraud and abuse considerations.

The presentation concluded with an overview, conducted by Audrey Anderson, of several executive orders issued during the first year of the Trump administration pertaining to gender affirming care as well as diversity, equity, and inclusion related grants and initiatives at AMCs.

Health Policy Fireside Chat: What to Expect from Congress and the Trump Administration in the Year Ahead

Bill Mathias, Member at Bass, Berry & Sims, engaged in a fireside chat with Colin Roskey, Principal at FHP Strategies, former Deputy Assistant Secretary at HHS, and former Senate Finance Committee Counsel under Senator Charles Grassley (R-IA). Bill asked Colin a series of questions about the current healthcare policy landscape in Washington.

Colin provided insights into the recent Texas primary elections and their implications for health policy in Congress. Bill and Colin also discussed the Trump administration’s healthcare policy efforts, with a heavy focus on lowering prescription drug prices and aggressive waste, fraud, and abuse enforcement. Bill and Colin highlighted the recent healthcare legislative changes that were included in the Consolidated Appropriations Act, which included, among other things, reforms to pharmacy benefit manager practices and a two-year extension of telehealth waivers. Colin addressed the site-neutral payment policy, noting that new requirements for off-campus hospital outpatient departments may signal further site-neutral payment reforms despite resistance from hospital groups. Colin also discussed the 340B Drug Pricing Program and questioned whether there was time in this election year for a bipartisan group of senators to make legislative changes to contract pharmacy arrangements and patient eligibility definitions.

Valuations in Value-Based Care: Strategies and Practical Considerations

Justin Brown, Member at Bass, Berry & Sims, and Curtis Bernstein, Partner at Pinnacle Healthcare Consulting, explored valuations of value-based care compensation models, including model design and development. In practical terms, value-based compensation should reward objectively verifiable, attributable improvements in quality and cost, or discrete activities reasonably designed to produce those improvements, using methodologies that are legally sound and supported by data-driven valuations. Through real-world examples, they highlighted the core features of several value-based care compensation models and the valuation and legal underpinnings of each.

Value-based care compensation models, like conventional compensation models, must be rooted in substance. Compensation should be tied to objectively measurable, attributable improvements—or activities designed to achieve improvements in quality and cost. The legal and compliance architecture should be designed into the model from the outset, as the model’s validity rests on its design. This architecture may take the form of a value-based enterprise (VBE) model that uses the value-based exceptions to the Stark Law and, if available, the value-based safe harbors to the Anti-Kickback Statute or the outcomes-based payments safe harbor.

The analytical framework for valuation is anchored in five interlocking concepts. Economic substance requires clarity about what is being improved and the financial effects of the improvement. Measure integrity demands objective, reviewable metrics within the physician’s control. Savings validity tests, whether reductions in spending or penalties, are real and quantifiable against credible benchmarks. Risk and accountability align payments with realized gains and withhold compensation absent performance. Proportionality ensures compensation is tied to value-based care contributions, while avoiding improper payments driven by the volume or value of referrals. Applying these concepts yields models that are both performance-oriented and data-driven.

Justin and Curtis offered several real-world illustrations. A quality incentive program for employed physicians, for example, can pair a conventional, productivity-based model with a defined quality bonus pool governed by individual and team scorecards. Process measures, such as adherence to clinical pathways and closing referral loops to improve care coordination, can incentivize specific activities designed to improve performance. Process measures are generally valued based on incremental time, effort, and resources, while avoiding double payment for routine duties. Outcome measures – such as readmissions, total cost of care, and patient-reported outcome measures – are valued using benchmarks, often with quality gates and minimum thresholds, and payment contingent on achievement.

An episode-based incentive program for hospitals and both employed and independent physicians, for example, can target high-expense, high-volume procedures in orthopedics and cardiology. The program can establish a historical cost baseline, measure performance against that baseline, and calculate the resulting savings pool. A clinical efficiency program can scale this approach across inpatient services, using diagnosis-related group cost benchmarking and percentile modeling to set credible targets and quantifying revenue at risk under the Hospital Readmissions Reduction Program, Hospital-Acquired Condition Reduction Program, Hospital Value-Based Purchasing Program, and other programs or arrangements to create a legitimate performance pool. Under both programs, the pool can be allocated among participants by measuring who contributed, and the extent to which they contributed, to the savings, often by applying quality thresholds and risk adjustments to allocate savings in proportion to documented contributions to quality and cost improvement.

In the end, Justin and Curtis emphasized that, although there are myriad ways to develop and implement value-based care compensation models, the keys to a data-driven valuation that support a legally compliant program should be grounded in economic substance, measure integrity, savings validity, risk and accountability, and proportionality. Applying this framework helps create a value-based care compensation model that is not only legally but also financially sound.

The Evolving Compliance Playbook for Medicare Advantage: What Plans and Providers Must Know

Dawn Perez-Slavinski, Member at Bass, Berry & Sims, and Nike Otuyelu, Chief Compliance Officer at Health Alliance Plan, led an informative presentation on emerging and ongoing compliance issues for Medicare Advantage Plans and Providers, discussing important takeaways from the recently released 2026 Medicare Advantage Industry Segment-Specific Compliance Program Guidance (MA ICPG).

Attendees heard important insights into emerging issues for Medicare Advantage compliance, including those related to risk adjustment, marketing and enrollment, and use of AI tools.

Dawn discussed:

  • The Office of Inspector General’s (OIG) focus on access to care – including provider network adequacy; accurate provider directories; and use emerging technology, such as AI utilization review tools – in coverage determinations. Dawn stated that plans should consider appropriate monitoring and auditing to identify and correct patterns of inappropriate denials or delays in care.
  • The continued OIG focus on marketing and enrollment activities. She stated that what OIG views as improper compensation and incentive structures were receiving increased scrutiny from both CMS and OIG. Dawn also discussed the OIG’s emphasis on enrollment structures that result in beneficiaries being enrolled in plans misaligned with their needs, as well as on industry practices that create inequitable competitive advantages for large plans over smaller regional plans.
  • The increasing complexity of Medicare Advantage, including the exponential increase in plans’ use of third-party vendors and supporting services. Dawn discussed how OIG views third-party vendors, leading to increased risk for Medicare Advantage plans absent appropriate plan oversight. The panelists discussed the importance of the systems a plan has in place for reporting obligations and escalation from a third party to the plan. Potential mitigation efforts include thorough training, attestation, and robust monitoring.
  • The increased complexity of Medicare Advantage ownership, including vertical integration, and the increased focus on investors in the space. Dawn discussed how OIG has become more sophisticated and aware of new entrants (including private equity firms) and OIG’s expectation that these new players gain familiarity with healthcare compliance issues.

Nike discussed:

  • Increased enforcement priority in risk adjustment due to the current administration’s priority on keeping costs down and reducing fraud, waste, and abuse. Improper diagnosis codes are a key area of focus for OIG, both in the compliance guidance and in recent enforcement actions. She stated that a primary area of focus is unsupported diagnoses arising from in-home assessments, and that OIG has flagged certain codes, such as those for heart attack and stroke, as increased risk for abuse. The panelists discussed recent OIG settlements related to unsupported diagnosis codes with payouts in the tens to hundreds of millions of dollar range. Nike also discussed mitigation efforts, including monitoring vendor and downstream coding activities, analyzing data trends in coding, and keeping strong oversight of providers to prevent unsupported coding practices from arising.
  • Increased sophistication and importance of quality of care and metric compliance in the new guidance compared to the prior 1999 guidance. She stated that risks include biased and inaccurate quality measure data, focusing on Star ratings and Quality Bonus Program payments that carry increased scrutiny, and failing to provide medically necessary services. Nike discussed key steps to risk mitigation in this area, including reviewing data to ensure accuracy and performing thorough credentialing evaluations on providers.
  • With respect to new corporate structures arising in the Medicare Advantage context, Nike stated that it is important that an organization’s compliance officer has access to the decision makers and that all new entrants to the Medicare Advantage space receive proper training and guidance on compliance risks.

This session concluded with key takeaways for Medicare Advantage plans when considering how their compliance program is structured and maintained, and expectations on enforcement risks in the Medicare Advantage space going forward.

On the OIG side:

  • The MA ICPG is much more detailed than the prior 1999 guidance. Regulators are becoming more sophisticated. OIG follows the money and understands the Medicare Advantage space and financial arrangements.
  • The scope of the compliance guidance has broadened; for example, investors are called out specifically in the guidance.
  • OIG does not prohibit the use of AI in Medicare Advantage Plan activities but maintains a measured skepticism towards technology.

On the industry side:

  • Consider revisiting the OIG’s seven elements of an effective compliance program, accounting for new tools and vendors that have entered the space.
  • Shore up contractual arrangements, as needed, especially as it relates to bonus and incentive payments.
  • Consider retraining where needed, including for third-party vendors.
  • Focus compliance program oversight on relationships most likely to increase government spending or result in patient harm.
  • Monitor for future rulemaking, especially on AI, marketing and enrollment, and risk adjustment. Make sure your partners understand compliance issues and revisit your program frequently and with new guidance in mind.

The Compliance Frontline: Evaluating Risk and Resilience

LeToia (LT) Crozier, Chief Compliance Officer at Mosaic Health, joined Krista Cooper and Lauren Gaffney, Members at Bass, Berry & Sims, to discuss how healthcare organizations can evaluate risk and build resilience through effective compliance programs. The panelists emphasized that while identifying risk is essential, true organizational strength lies in how an organization responds when something goes wrong.

In evaluating an effective compliance program, the panelists noted that the DOJ continues to prioritize board accountability, compliance program evolution, and oversight and implementation of data analytics and AI. The HHS-OIG’s focus areas – continuous monitoring, risk-based auditing, chief compliance officer independence, and board engagement – were also highlighted as key benchmarks for organizational readiness. LT communicated the importance of framing risks in the context of the organization’s specific business operations and communicating effectively with leadership.

The panelists also discussed compliance considerations in the deal context, noting that the quality of earnings does not necessarily equate to the quality of a compliance program. Due diligence should assess billing analytics, compensation alignment, state transaction review requirements, AI-driven revenue systems, and post-close integration planning. LT and Krista addressed post-acquisition integration, both advocating for advanced preparation and quick action on risks identified in due diligence so that buyers can operate the business compliantly from day one.

From an operational standpoint, the panelists stressed that compliance officers must deeply understand their organization’s specific business operations to effectively assess risk. Practical implementation steps include adopting enterprise risk management frameworks, developing targeted Key Risk Indicators tailored to the organization’s unique risk profile, and eliminating senseless policies in favor of focused, business-specific guidance. Increasingly, compliance officers must address the rapidly evolving risks associated with AI by implementing structures for AI governance and algorithmic accountability. Organizations should ask where AI is being used, who audits outputs, who tracks overrides, whether vendors are held accountable, and whether bias is monitored. The panelists also emphasized that compliance programs should not be treated as static checklists but as adaptable frameworks that evolve in response to changing regulations and emerging risks like AI.

The session concluded with a case study illustrating post-acquisition compliance challenges. In walking through the case study, LT advised that organizations facing compliance issues should immediately stop the risk-generating practice, engage legal counsel to assess exposure, consider reporting obligations, and document all remediation efforts to demonstrate a commitment to compliance improvement.

The session’s overarching takeaway was clear: static risk assessments are obsolete, and resilient compliance programs must be dynamic and data driven. The most effective compliance programs are adaptable frameworks that evolve in response to changing regulations and emerging risks like AI.

Conclusion

The 2026 Summit highlighted the importance of staying attuned to the rapidly evolving demands of regulatory compliance and ensuring that healthcare organizations approach novel issues thoughtfully and thoroughly. If you have any questions, please do not hesitate to contact our attorneys.

Bass, Berry & Sims thanks everyone who attended this year’s Summit. We look forward to hosting the event again next year.

Related Professionals
Related Services
Firm Publication

Bass, Berry & Sims hosted its second annual Healthcare Regulatory & Compliance Summit on March 4. Our attorneys were joined by panelists from Wayspring, Dartmouth Health, FHP Strategies, Pinnacle Healthcare Consulting, HAP, and Mosaic Health.

The Summit welcomed in-house counsel, compliance officers, and C-suite executives from across the healthcare industry to the firm’s office at Nashville Yards.

The Healthcare Regulatory Year in Review

Anna Grizzle and Travis Lloyd, Members at Bass, Berry & Sims, provided a comprehensive overview of the significant regulatory shifts affecting the healthcare industry over the past year. Against the backdrop of the new administration’s policy priorities—including the Make America Healthy Again (MAHA) initiative, vaccine policy reforms, gender affirming care restrictions, Medicaid cuts under the One Big Beautiful Bill Act (OBBBA), and substantial federal workforce reductions—the session examined four key areas of regulatory development that demand the attention of healthcare stakeholders. These included the Rural Health Transformation Program, new Centers for Medicare & Medicaid Services (CMS) fraud and abuse initiatives, key payment rule updates, and healthcare fraud enforcement.

The Rural Health Transformation Program, established under OBBBA, represents a substantial $50 billion investment over five years aimed at improving care and health outcomes in rural communities. The program allocates funding to states based on both approval of a request for funding and factors such as ruralness, state policies, and application quality, with strategic goals spanning MAHA, sustainable access, workforce development, innovative care, and technology innovation. Following an aggressive timeline with applications opening in September 2025 and awards granted in December 2025, Texas and Alaska emerged as the largest funding recipients—Texas for its rural telehealth and artificial intelligence (AI) initiatives and Alaska for its transition to a value-based payment model. CMS monitoring of these programs commenced in the first quarter of 2026.

On the fraud and abuse front, CMS has adopted an increasingly aggressive posture, shifting its approach from “pay and chase” to “prevent and detect” through initiatives such as the Wasteful and Inappropriate Service Reduction (WISeR) model, which requires prior authorization for 17 service categories susceptible to fraud and utilizes private sector AI partners across six pilot states. CMS has also announced plans to accelerate Risk Adjustment Data Validation (RADV) audits for plan years 2018 through 2024; and has implemented a nationwide moratorium on Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) enrollment and launched the Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative seeking stakeholder input on fraud prevention strategies. Regarding payment rules, notable updates include expansion of the ambulatory surgery center (ASC) covered procedures list, a three-year phase-out of the inpatient-only list beginning in calendar year 2026, permanent adoption of virtual direct supervision, and significant changes to skin substitute reimbursement methodology. The session also highlighted ongoing site-neutral payment developments and new provider-based attestation requirements under the Consolidated Appropriations Act of 2026.

Healthcare fraud enforcement reached record levels in fiscal year 2025, with $6.9 billion in civil fraud recoveries—83% of which stemmed from healthcare matters. The renewed Department of Justice (DOJ)-Department of Health and Human Services (HHS) False Claims Act (FCA) Working Group has prioritized Medicare Advantage and pharmaceutical enforcement, while criminal actions have targeted telemedicine fraud, opioid prescribing schemes, and wound care abuses, resulting in $14.7 billion in identified false claims and charges against 324 defendants across 50 federal districts. Given the particular focus on skin substitutes, wound care providers should prioritize compliance in this area and ensure all documentation meets requirements. The session noted significant legal developments, including the constitutional challenge to FCA qui tam provisions in Zafirov v. Florida Medical Associates, which, if upheld, would potentially change the landscape of fraud and abuse enforcement, as well as new compliance guidance, including the first Medicare Advantage-specific compliance program guidance in over 26 years.

The speakers concluded by emphasizing that while new administration priorities have emerged, traditional enforcement areas remain a focus, and stakeholders should expect sustained attention on Medicare Advantage, site-neutral payment policies, and price transparency initiatives.

Tips & Tricks in Evaluating and Implementing Value-Based Care Arrangements

Danielle Sloane, Member at Bass Berry & Sims, and Alice Heywood, Chief Legal Officer at Wayspring, presented on the evolving healthcare landscape and value-based care arrangements under the current administration’s initiatives. The presentation was based on their upcoming content to be released in the Health Law Handbook, 2026 Edition.

Danielle and Alice talked about how the OIG’s finalized rules helped to modernize the Stark Law, Anti-Kickback Statute, and Civil Monetary Penalties Law as part of HHS’s “regulatory sprint to coordinated care,” aiming to enable value-based care, improve technology infrastructure, and encourage innovation. Despite political changes, momentum toward value-based care has continued, with CMS maintaining its goal of placing all Medicare beneficiaries in value-based arrangements by 2030. Recent federal initiatives—including the Trump administration’s “MAHA” agenda and new CMS Innovation Center strategies—reinforce a long-term commitment to prevention, wellness, reduced acute care use, and greater care coordination.

Value-based care has also expanded across commercial markets. While Medicare Advantage continues to lead, commercial risk-based models surpassed Medicaid in 2023, driven by employer interest and payer investment. Major insurers and health systems are increasingly participating through direct investments, partnerships, or launching their own health plans, signaling that value-based care is becoming a standard feature of the healthcare landscape.

For providers, success in value-based care requires improving outcomes while managing costs, negotiating complex payer agreements, and making upfront investments in technology, data analytics, and care coordination. Many organizations now have greater experience and comfort with these models, and even those that previously hesitated are entering the space—either by choice or mandate—making readiness to evaluate and negotiate value-based arrangements essential for most healthcare stakeholders.

To read the full content Danielle and Alice provided for the Health Law Handbook, 2026 Edition, click here.

Hot Topics in Academic Medical Centers

Audrey Wilson, Deputy General Counsel at Dartmouth Health, and Scott Shanker and Audrey Anderson, Member and Counsel at Bass, Berry & Sims, respectively, provided an overview of the significant regulatory challenges impacting academic medical centers (AMCs). The speakers offered their thoughts on how to navigate the especially complex healthcare regulatory landscape in which AMCs operate, with special focus on AMCs’ increased involvement in hospital acquisitions and physician alignment.

The panelists discussed the factors that separate AMCs from other healthcare provider systems, and how there is inconsistency under federal and state laws in even defining the terms “academic medical center” or “faculty practice plan,” resulting in reliance on the academic medical Center exception under the Stark Law. Throughout the presentation, the speakers emphasized the uniqueness of AMCs, emphasizing varying governance structures, academic missions, and medical innovation, while balancing teaching, clinical and research performed by AMC physicians.

The speakers discussed regulatory considerations relating to physician compensation, with federal healthcare fraud and abuse laws in general, and the Stark Law in particular, being of note. The speakers touched on the importance of a fair market value (FMV) payment to physicians that does not take into account the volume or value of referrals (or other business generated). In determining FMV, credible valuation data needs to be memorialized and ongoing monitoring of compensation is necessary to ensure compliance. The speakers also discussed joint ventures at AMCs, along with the strategic rationale driving these types of arrangements. The speakers analyzed potential issues relating to board representation, voting rights, reserved powers, physician clinical committees, financial risk, and joint research outcomes and publications.

Research and grant compliance at AMCs is a hot button topic, as this area requires significant financial commitment and compliance with scientific and ethical standards. In this part of the presentation, the speakers described this highly complex regulatory environment, which intersects with a multitude of legal issues including the Common Rule and human subject protections, Food and Drug Administration (FDA) regulations for clinical trials, Institutional Review Board (IRB) approvals, National Institutes of Health (NIH) grant applications, and healthcare fraud and abuse considerations.

The presentation concluded with an overview, conducted by Audrey Anderson, of several executive orders issued during the first year of the Trump administration pertaining to gender affirming care as well as diversity, equity, and inclusion related grants and initiatives at AMCs.

Health Policy Fireside Chat: What to Expect from Congress and the Trump Administration in the Year Ahead

Bill Mathias, Member at Bass, Berry & Sims, engaged in a fireside chat with Colin Roskey, Principal at FHP Strategies, former Deputy Assistant Secretary at HHS, and former Senate Finance Committee Counsel under Senator Charles Grassley (R-IA). Bill asked Colin a series of questions about the current healthcare policy landscape in Washington.

Colin provided insights into the recent Texas primary elections and their implications for health policy in Congress. Bill and Colin also discussed the Trump administration’s healthcare policy efforts, with a heavy focus on lowering prescription drug prices and aggressive waste, fraud, and abuse enforcement. Bill and Colin highlighted the recent healthcare legislative changes that were included in the Consolidated Appropriations Act, which included, among other things, reforms to pharmacy benefit manager practices and a two-year extension of telehealth waivers. Colin addressed the site-neutral payment policy, noting that new requirements for off-campus hospital outpatient departments may signal further site-neutral payment reforms despite resistance from hospital groups. Colin also discussed the 340B Drug Pricing Program and questioned whether there was time in this election year for a bipartisan group of senators to make legislative changes to contract pharmacy arrangements and patient eligibility definitions.

Valuations in Value-Based Care: Strategies and Practical Considerations

Justin Brown, Member at Bass, Berry & Sims, and Curtis Bernstein, Partner at Pinnacle Healthcare Consulting, explored valuations of value-based care compensation models, including model design and development. In practical terms, value-based compensation should reward objectively verifiable, attributable improvements in quality and cost, or discrete activities reasonably designed to produce those improvements, using methodologies that are legally sound and supported by data-driven valuations. Through real-world examples, they highlighted the core features of several value-based care compensation models and the valuation and legal underpinnings of each.

Value-based care compensation models, like conventional compensation models, must be rooted in substance. Compensation should be tied to objectively measurable, attributable improvements—or activities designed to achieve improvements in quality and cost. The legal and compliance architecture should be designed into the model from the outset, as the model’s validity rests on its design. This architecture may take the form of a value-based enterprise (VBE) model that uses the value-based exceptions to the Stark Law and, if available, the value-based safe harbors to the Anti-Kickback Statute or the outcomes-based payments safe harbor.

The analytical framework for valuation is anchored in five interlocking concepts. Economic substance requires clarity about what is being improved and the financial effects of the improvement. Measure integrity demands objective, reviewable metrics within the physician’s control. Savings validity tests, whether reductions in spending or penalties, are real and quantifiable against credible benchmarks. Risk and accountability align payments with realized gains and withhold compensation absent performance. Proportionality ensures compensation is tied to value-based care contributions, while avoiding improper payments driven by the volume or value of referrals. Applying these concepts yields models that are both performance-oriented and data-driven.

Justin and Curtis offered several real-world illustrations. A quality incentive program for employed physicians, for example, can pair a conventional, productivity-based model with a defined quality bonus pool governed by individual and team scorecards. Process measures, such as adherence to clinical pathways and closing referral loops to improve care coordination, can incentivize specific activities designed to improve performance. Process measures are generally valued based on incremental time, effort, and resources, while avoiding double payment for routine duties. Outcome measures – such as readmissions, total cost of care, and patient-reported outcome measures – are valued using benchmarks, often with quality gates and minimum thresholds, and payment contingent on achievement.

An episode-based incentive program for hospitals and both employed and independent physicians, for example, can target high-expense, high-volume procedures in orthopedics and cardiology. The program can establish a historical cost baseline, measure performance against that baseline, and calculate the resulting savings pool. A clinical efficiency program can scale this approach across inpatient services, using diagnosis-related group cost benchmarking and percentile modeling to set credible targets and quantifying revenue at risk under the Hospital Readmissions Reduction Program, Hospital-Acquired Condition Reduction Program, Hospital Value-Based Purchasing Program, and other programs or arrangements to create a legitimate performance pool. Under both programs, the pool can be allocated among participants by measuring who contributed, and the extent to which they contributed, to the savings, often by applying quality thresholds and risk adjustments to allocate savings in proportion to documented contributions to quality and cost improvement.

In the end, Justin and Curtis emphasized that, although there are myriad ways to develop and implement value-based care compensation models, the keys to a data-driven valuation that support a legally compliant program should be grounded in economic substance, measure integrity, savings validity, risk and accountability, and proportionality. Applying this framework helps create a value-based care compensation model that is not only legally but also financially sound.

The Evolving Compliance Playbook for Medicare Advantage: What Plans and Providers Must Know

Dawn Perez-Slavinski, Member at Bass, Berry & Sims, and Nike Otuyelu, Chief Compliance Officer at Health Alliance Plan, led an informative presentation on emerging and ongoing compliance issues for Medicare Advantage Plans and Providers, discussing important takeaways from the recently released 2026 Medicare Advantage Industry Segment-Specific Compliance Program Guidance (MA ICPG).

Attendees heard important insights into emerging issues for Medicare Advantage compliance, including those related to risk adjustment, marketing and enrollment, and use of AI tools.

Dawn discussed:

  • The Office of Inspector General’s (OIG) focus on access to care – including provider network adequacy; accurate provider directories; and use emerging technology, such as AI utilization review tools – in coverage determinations. Dawn stated that plans should consider appropriate monitoring and auditing to identify and correct patterns of inappropriate denials or delays in care.
  • The continued OIG focus on marketing and enrollment activities. She stated that what OIG views as improper compensation and incentive structures were receiving increased scrutiny from both CMS and OIG. Dawn also discussed the OIG’s emphasis on enrollment structures that result in beneficiaries being enrolled in plans misaligned with their needs, as well as on industry practices that create inequitable competitive advantages for large plans over smaller regional plans.
  • The increasing complexity of Medicare Advantage, including the exponential increase in plans’ use of third-party vendors and supporting services. Dawn discussed how OIG views third-party vendors, leading to increased risk for Medicare Advantage plans absent appropriate plan oversight. The panelists discussed the importance of the systems a plan has in place for reporting obligations and escalation from a third party to the plan. Potential mitigation efforts include thorough training, attestation, and robust monitoring.
  • The increased complexity of Medicare Advantage ownership, including vertical integration, and the increased focus on investors in the space. Dawn discussed how OIG has become more sophisticated and aware of new entrants (including private equity firms) and OIG’s expectation that these new players gain familiarity with healthcare compliance issues.

Nike discussed:

  • Increased enforcement priority in risk adjustment due to the current administration’s priority on keeping costs down and reducing fraud, waste, and abuse. Improper diagnosis codes are a key area of focus for OIG, both in the compliance guidance and in recent enforcement actions. She stated that a primary area of focus is unsupported diagnoses arising from in-home assessments, and that OIG has flagged certain codes, such as those for heart attack and stroke, as increased risk for abuse. The panelists discussed recent OIG settlements related to unsupported diagnosis codes with payouts in the tens to hundreds of millions of dollar range. Nike also discussed mitigation efforts, including monitoring vendor and downstream coding activities, analyzing data trends in coding, and keeping strong oversight of providers to prevent unsupported coding practices from arising.
  • Increased sophistication and importance of quality of care and metric compliance in the new guidance compared to the prior 1999 guidance. She stated that risks include biased and inaccurate quality measure data, focusing on Star ratings and Quality Bonus Program payments that carry increased scrutiny, and failing to provide medically necessary services. Nike discussed key steps to risk mitigation in this area, including reviewing data to ensure accuracy and performing thorough credentialing evaluations on providers.
  • With respect to new corporate structures arising in the Medicare Advantage context, Nike stated that it is important that an organization’s compliance officer has access to the decision makers and that all new entrants to the Medicare Advantage space receive proper training and guidance on compliance risks.

This session concluded with key takeaways for Medicare Advantage plans when considering how their compliance program is structured and maintained, and expectations on enforcement risks in the Medicare Advantage space going forward.

On the OIG side:

  • The MA ICPG is much more detailed than the prior 1999 guidance. Regulators are becoming more sophisticated. OIG follows the money and understands the Medicare Advantage space and financial arrangements.
  • The scope of the compliance guidance has broadened; for example, investors are called out specifically in the guidance.
  • OIG does not prohibit the use of AI in Medicare Advantage Plan activities but maintains a measured skepticism towards technology.

On the industry side:

  • Consider revisiting the OIG’s seven elements of an effective compliance program, accounting for new tools and vendors that have entered the space.
  • Shore up contractual arrangements, as needed, especially as it relates to bonus and incentive payments.
  • Consider retraining where needed, including for third-party vendors.
  • Focus compliance program oversight on relationships most likely to increase government spending or result in patient harm.
  • Monitor for future rulemaking, especially on AI, marketing and enrollment, and risk adjustment. Make sure your partners understand compliance issues and revisit your program frequently and with new guidance in mind.

The Compliance Frontline: Evaluating Risk and Resilience

LeToia (LT) Crozier, Chief Compliance Officer at Mosaic Health, joined Krista Cooper and Lauren Gaffney, Members at Bass, Berry & Sims, to discuss how healthcare organizations can evaluate risk and build resilience through effective compliance programs. The panelists emphasized that while identifying risk is essential, true organizational strength lies in how an organization responds when something goes wrong.

In evaluating an effective compliance program, the panelists noted that the DOJ continues to prioritize board accountability, compliance program evolution, and oversight and implementation of data analytics and AI. The HHS-OIG’s focus areas – continuous monitoring, risk-based auditing, chief compliance officer independence, and board engagement – were also highlighted as key benchmarks for organizational readiness. LT communicated the importance of framing risks in the context of the organization’s specific business operations and communicating effectively with leadership.

The panelists also discussed compliance considerations in the deal context, noting that the quality of earnings does not necessarily equate to the quality of a compliance program. Due diligence should assess billing analytics, compensation alignment, state transaction review requirements, AI-driven revenue systems, and post-close integration planning. LT and Krista addressed post-acquisition integration, both advocating for advanced preparation and quick action on risks identified in due diligence so that buyers can operate the business compliantly from day one.

From an operational standpoint, the panelists stressed that compliance officers must deeply understand their organization’s specific business operations to effectively assess risk. Practical implementation steps include adopting enterprise risk management frameworks, developing targeted Key Risk Indicators tailored to the organization’s unique risk profile, and eliminating senseless policies in favor of focused, business-specific guidance. Increasingly, compliance officers must address the rapidly evolving risks associated with AI by implementing structures for AI governance and algorithmic accountability. Organizations should ask where AI is being used, who audits outputs, who tracks overrides, whether vendors are held accountable, and whether bias is monitored. The panelists also emphasized that compliance programs should not be treated as static checklists but as adaptable frameworks that evolve in response to changing regulations and emerging risks like AI.

The session concluded with a case study illustrating post-acquisition compliance challenges. In walking through the case study, LT advised that organizations facing compliance issues should immediately stop the risk-generating practice, engage legal counsel to assess exposure, consider reporting obligations, and document all remediation efforts to demonstrate a commitment to compliance improvement.

The session’s overarching takeaway was clear: static risk assessments are obsolete, and resilient compliance programs must be dynamic and data driven. The most effective compliance programs are adaptable frameworks that evolve in response to changing regulations and emerging risks like AI.

Conclusion

The 2026 Summit highlighted the importance of staying attuned to the rapidly evolving demands of regulatory compliance and ensuring that healthcare organizations approach novel issues thoughtfully and thoroughly. If you have any questions, please do not hesitate to contact our attorneys.

Bass, Berry & Sims thanks everyone who attended this year’s Summit. We look forward to hosting the event again next year.

In Case You Missed It: