Schedule

• Health Equity and Access Post-Dobbs and patient care issues (EMTALA and clinical research updates)

• False Claims Act case law and settlements (key cases and enforcement trends)

• Stark and Anti-kickback developments

• Telemedicine updates and impact of expiration of state license waivers

• Health Care Transactions (from hot trends, to record number of bankruptcies, to private equity, to tax issues, to new antitrust theories)

• Hot HIT developments (artificial intelligence, cyber-attacks, information blocking and interoperability, OCR enforcement, and state laws)

• Price transparency enforcement and drug prices litigation

• Reimbursement trends and 340B

• And much more!

• Is the expansion of the role of Private Equity in the health care industry a positive or a negative?

  • Pros

  • Cons

• Why is the government focusing on PE investments in health care?

• What factors increase the risk of government scrutiny of PE role in health care enterprise?

• What types of actions/investments by PE are likely to garner media attention?

• Antitrust scrutiny of PE investments in health care

Academic medical centers are facing a growing interest in unionization among residents and trainees. What’s driving this and what can institutions do to address this trend? Join Trecia Moore to analyze the trend and provide tips to address and protect against potential unionization.

This session will explore how financial pressures and changing market dynamics are forcing players in healthcare to rethink the physician enterprise in order to be competitive in new economic and strategic climates. The growing momentum for value-based care and the impact of complex payor negotiations is driving hospitals and physicians towards varying degrees of collaboration and integration. This presentation will highlight provider alignment models, and examine how academic medical centers, community hospitals and physicians can work together to remain competitive, meet financial objectives, and position themselves in light of new market disruptors.  The program will also focus on how value-based payment models and new technologies are redefining the traditional physician enterprise.

• An illustrated discussion of the drug distribution chain and the hospital’s role therein

• The Medicare program’s implementation of drug reimbursement reductions resulting from the Inflation Reduction Act

• Update on the resolution of the Supreme Court decision reversing CMS 340B underpayments, both with respect to Medicare fee for service, as well as strategies for dealing with MA plans

• State and Federal legislation and litigation affecting 340B utilization

• Considerations for health systems as employers seeking to control their own drug spends

This session will bring differing perspectives from in-house counsel for the health care entity, outside counsel for the medical staff, and counsel for the physician under peer review to provide the audience with insights through interactive discussion of hypotheticals touching on the following topics:

• How to approach and work with physicians and medical staffs when wellness or health issues arise due to new or increased complaints, expressed concerns from colleagues, or trending data showing the need for a potential slow down of practice

• Best practices for the hospital, medical staff, and physician when participating in collegial interventions and investigations and discussion of the NPDB’s updated guidance regarding when an investigation begins and reporting requirements for resignation while under or to avoid investigation

• Options for avoiding the fair hearing process, including strong medical staff bylaws language and using experienced counsel to come to a reasonable resolution

• Key items to know when the fair hearing is unavoidable to promote a fair and efficient process for the physician and the medical staff

• Recent trends in health care contracting, including payer-provider, employees, vendors, and more 

• Effective contracting and litigation strategies to help reduce litigation costs, including terms to streamline the dispute resolution process

• High-risk areas of litigation for hospitals and medical groups

• The litigation management tools and strategies used by in-house attorneys to control costs

• Digital health and AI industry regulators and applicable laws

• AI in health care–what’s going on and where is regulation of AI headed? 

  • President Biden’s Executive Order and the role of HHS

  • ONC’s finalization of rule to increase algorithm transparency

• Legal risk areas for digital health and AI, including privacy, corporate practice of medicine, fraud and abuse, and FDA regulation of medical devices

• Recent developments in digital health and AI, including enforcement actions and regulatory guidance 

  • HHS OIG Special Fraud Alert on Telehealth

  • FTC actions regarding AI

  • FDA actions regarding AI

This session will discuss Stark/AKS issues that arise in hospital/physician arrangements. In particular, we will address:

• Employment and Professional Service Agreements (including common compensation models and warnings provided by recent settlements)

• Transfer of funds between components of an AMC and the indirect compensation analysis under the Stark Law

• Joint ventures involving hospitals and physicians

• Physician recruitment agreements

• Trends, practices, and tips across roles in disputes between physicians/health systems and payers, particularly in navigating the provider/hospital services agreements

• Highlighted opportunities for improved positioning from multiple perspectives—provider, payer, arbitrator, and expert—when resolving such disputes

• How to (1) anticipate such disputes, (2) establish robust processes for evidence preparation for such disputes, and (3) efficiently navigate such disputes

• Typical contractual clauses in dispute and explore the stages of the disputes

• The presentation is aimed to equip the audience with a comprehensive understanding of how to navigate and strategically approach provider/payer disputes in the current landscape

• Merger policy – what’s new and what’s not for health care providers

• Withdrawal of the Health Care Guidelines

• Proposed rule on non-compete agreements in employment contracts

• Private equity – why the hostility?

• Increasing state AG interest in provider mergers

• And much more

• Hospitals and corporations continue to acquire medical practices. These acquisitions were further accelerated due to COVID-19

• As a result, securing affordable and efficient hospital-based clinical coverage is even more challenging

• Financial support for and the costs to employ hospital-based coverage is a material expense for any health system

• We will share our experience and solutions when it comes to contracting with medical groups for this coverage and in employing physicians and APPs for these service lines

• Specifically, navigating pitfalls and challenges with regards to high staffing costs for physicians and APPs, rising profit margins and management fees, survey lag, volume and utilization

• Securing a cost-effective, compliant coverage does not have to be a daunting task

This session will bring differing perspectives from in-house counsel for the health care entity, outside counsel for the medical staff, and counsel for the physician under peer review to provide the audience with insights through interactive discussion of hypotheticals touching on the following topics:

• How to approach and work with physicians and medical staffs when wellness or health issues arise due to new or increased complaints, expressed concerns from colleagues, or trending data showing the need for a potential slow down of practice

• Best practices for the hospital, medical staff, and physician when participating in collegial interventions and investigations and discussion of the NPDB’s updated guidance regarding when an investigation begins and reporting requirements for resignation while under or to avoid investigation

• Options for avoiding the fair hearing process, including strong medical staff bylaws language and using experienced counsel to come to a reasonable resolution

• Key items to know when the fair hearing is unavoidable to promote a fair and efficient process for the physician and the medical staff

• Review of UPIC activity

• What is the scope of the UPIC?

• Can the UPIC really ask for all that information?

• How do you deal with a payment suspension?

• What happens after the UPIC audit?

• Legal counsel support of governance and management – Who is the client? What rules apply?

• Providing governance and management legal support in between meetings

• Board and individual Board member duties – Accreditation and legal standards

• Maintaining privilege and sharing information with management and governance

• D&O coverage and immunity – Limitations and practical considerations

• Digital health and AI industry regulators and applicable laws

• AI in health care–what’s going on and where is regulation of AI headed? 

  • President Biden’s Executive Order and the role of HHS

  • ONC’s finalization of rule to increase algorithm transparency

• Legal risk areas for digital health and AI, including privacy, corporate practice of medicine, fraud and abuse, and FDA regulation of medical devices

• Recent developments in digital health and AI, including enforcement actions and regulatory guidance 

  • HHS OIG Special Fraud Alert on Telehealth

  • FTC actions regarding AI

  • FDA actions regarding AI

This session will discuss the promises of Remote Physiological Monitoring (RPM) and Remote Therapeutic Monitoring (RTM) while explaining the regulatory and reimbursement rules approaches to overcome operational challenges, and contractual relationships with remote care delivery partners, including:

• RPM and RTM CPT codes and reimbursement rules, including a summary of current rules and the most recent changes in the 2024 Physician Fee Schedule final rule

• Use and reimbursement of telehealth when providing RPM and RTM

• Partnering with third parties, including fraud and abuse implications, supervision issues,  referral partners relationships, and contractual issues

• Use of technology in RPM and RTM, including vetting technology providers, types of devices, availability and access to broadband, and privacy & security considerations

• Use of RPM and RTM to address health equity goals and health care disparity, especially in rural areas,  and addressing low technology literacy

• Operational considerations in implementing and operating RPM/RTM, including data flows and integration challenges

• The intersection of RPM and RTM with broader patient care management services and in-person care

• Mitigating risks related to use of RPM and RTM, including documentation and overutilization concerns

• Trends, practices, and tips across roles in disputes between physicians/health systems and payers, particularly in navigating the provider/hospital services agreements

• Highlighted opportunities for improved positioning from multiple perspectives—provider, payer, arbitrator, and expert—when resolving such disputes

• How to (1) anticipate such disputes, (2) establish robust processes for evidence preparation for such disputes, and (3) efficiently navigate such disputes

• Typical contractual clauses in dispute and explore the stages of the disputes

• The presentation is aimed to equip the audience with a comprehensive understanding of how to navigate and strategically approach provider/payer disputes in the current landscape

• The use of technology beyond the EHR

• The value add of applications-including creating more efficiency and streamlining

• Providers agreeing to terms with a third parties that allow for sharing of information

• Whose legal obligation is it when the organization’s data gets shared inappropriately?

• The organization’s practical responsibilities even if a legal obligation does not exist?

• Practical ways to raise the awareness of providers

Health care now is furnished not only in the provider’s office, but also in homes, offices, and other settings. Providers often are in different locations than their patients providing both in-person care and virtual care. In this intermediate-level session, the presenters will cover:

• An overview of the key features of virtual provider networks (VPNs) and real-life examples of nursing, telehealth and ACO VPNs

• How VPNs are impacting care delivery, payer-provider relations, network adequacy, and contracting

• Development and implementation of a legally compliant structure and operations

• Some of the most common and complex issues VPNs present, including corporate practice of medicine, licensing, supervision rules, and cyber issues

• Practice pointers and practical solutions for professionals working with VPNs

This session covers best practices for drafting arbitration agreements, filing claims, and resolving cases efficiently and effectively.  We all learn from mistakes, but it's best to learn from the ones others have made!  Come join this special breakfast.

• The Lasso Way: Describe current and future regulations that govern provider arrangements and resulting implications to organization operations

• Details specific to recent enforcement actions related to the volume of cases by year and associated outcomes/settlement dollars

• Trends in recent enforcement actions relate to specialty, compensation components and methodology, and documentation compliance

• Teamwork Makes the Dream Work: Introduce the DOJ’s Health Care Fraud Unit

• The Playbook of Trust: Summarize the DOJ Corporate Compliance Priorities

• Merger policy – what’s new and what’s not for health care providers

• Withdrawal of the Health Care Guidelines

• Proposed rule on non-compete agreements in employment contracts

• Private equity – why the hostility?

• Increasing state AG interest in provider mergers

• And much more

• Is the expansion of the role of Private Equity in the health care industry a positive or a negative?

  • Pros

  • Cons

• Why is the government focusing on PE investments in health care?

• What factors increase the risk of government scrutiny of PE role in health care enterprise?

• What types of actions/investments by PE are likely to garner media attention?

• Antitrust scrutiny of PE investments in health care

• An illustrated discussion of the drug distribution chain and the hospital’s role therein

• The Medicare program’s implementation of drug reimbursement reductions resulting from the Inflation Reduction Act

• Update on the resolution of the Supreme Court decision reversing CMS 340B underpayments, both with respect to Medicare fee for service, as well as strategies for dealing with MA plans

• State and Federal legislation and litigation affecting 340B utilization

• Considerations for health systems as employers seeking to control their own drug spends

• Legal counsel support of governance and management – Who is the client? What rules apply?

• Providing governance and management legal support in between meetings

• Board and individual Board member duties – Accreditation and legal standards

• Maintaining privilege and sharing information with management and governance

• D&O coverage and immunity – Limitations and practical considerations

This session will discuss Stark/AKS issues that arise in hospital/physician arrangements. In particular, we will address:

• Employment and Professional Service Agreements (including common compensation models and warnings provided by recent settlements)

• Transfer of funds between components of an AMC and the indirect compensation analysis under the Stark Law

• Joint ventures involving hospitals and physicians

• Physician recruitment agreements

Health care now is furnished not only in the provider’s office, but also in homes, offices, and other settings. Providers often are in different locations than their patients providing both in-person care and virtual care. In this intermediate-level session, the presenters will cover:

• An overview of the key features of virtual provider networks (VPNs) and real-life examples of nursing, telehealth and ACO VPNs

• How VPNs are impacting care delivery, payer-provider relations, network adequacy, and contracting

• Development and implementation of a legally compliant structure and operations

• Some of the most common and complex issues VPNs present, including corporate practice of medicine, licensing, supervision rules, and cyber issues

• Practice pointers and practical solutions for professionals working with VPNs

• Research-intensive AMCs are now manufacturing some of the investigational medical products for use in their own clinical trials. The manufacturing involved may be relatively simple or very sophisticated, with products ranging from mobile device health applications and food flours for allergy testing to cell and gene therapies that require aseptic processing facilities

• Beyond FDA’s IND and IDE regulations, these projects are subject to FDA regulations specific to manufacturing, but the application of these manufacturing regulations to early stage (Phase I and II) clinical trials can be unclear

• The panel consists of two attorneys who have navigated these issues in the AMC and industry environments and an expert regulatory consultant and engineer who is Lead Auditor trained and regularly audits clients for compliance with FDA’s Good Manufacturing Practice (GMP) requirements, including quality systems planning and architecture and risk-based remediation

• Discuss various types of AMC manufacturing projects; the legal, insurance, business, and practical considerations involved in investigational product manufacturing; and the regulatory landscape, including FDA’s interpretation of its own manufacturing regulations in the context of academic manufacturing.  We will also touch on issues that may arise when collaborating with industry to manufacture investigational products in the AMC setting.

• Reserved time for discussion and invite questions and commentary from the audience