Schedule

Prior to kicking off the Physicians and Hospitals Law Institute, AHLA will be holding an In-House Counsel Think Tank. This is a guided conversation with practicing in-house counsel discussing the many challenges confronted in business today. The focus of the discussion will be centered around:

• Legal department challenges of demonstrating value to the organization and doing more with less
• Effective outside counsel management
• Operational challenges of difficult patient discharges
• Responding to violence in the workplace
• Employees facing potential criminal liability arising from work duties

Promising to be more entertaining than watching paint dry, our newly reorganized panel (welcome, Cindy Wisner), will cover key developments over the past year and identify industry and enforcement trends. Highlights include:
 

• Post-Dobbs fallout 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
• The rise of telemedicine and its survival past the end of the Public Health Emergency
• Health Care Transactions (from hot trends, to record number of bankruptcies, to private equity, to tax issues, to new antitrust theories)
• Hot HIT developments (cyber-attacks, information blocking and interoperability, OCR enforcement, and new state laws)
• The Surprising first year of No Surprises
• Updates on price transparency and drug prices
• Reimbursement trends and 340B
• And much more!

• Health equity in the health care provider setting
• Laws and policies that shape health outcomes
• Health equity frameworks and implementation strategies for hospitals and physicians
• Best practices and health system examples

• The prior year’s court cases, regulatory actions, and other developments of note for physician and other healthcare transaction reviews
• Our opinion of the top ten issues of concern and what counsel, compliance officers, and consultants need to know about them
• A recap of the major issues of the past decade and how they compare to the past year, including recurring themes and what has changed or remained the same
• Our outlook, tips, and takeaways for navigating trouble spots efficiently and effectively in 2023

AMCs and hospital systems are increasingly being approached to share huge volumes of clinical data, biospecimens, and genomics sequencing data derived from those biospecimens with a variety of partners, including pharmaceutical companies, biotech companies, AI and machine-learning companies, and other collaborative research partners. This will be a masters-level program that will cover the following topics:
 

• What are best practices for handling identifiable and de-identified data in these transactions in a manner that complies with HIPAA and state privacy laws?
• What special protections are warranted for genomics data given the evolving state genetic privacy laws and the sensitivity of this information?
• What research compliance issues are presented through structuring these deals as collaborative research efforts?
• What are particularly challenging business issues presented by these deals, such as structuring equity investments, warrants and other compensation for engagement in these collaborations?
• What IP issues are presented in these deals?

• Examples of financial relationships between attorney and health care client
• Ethical rules impacting financial relationships with clients
• Judicial and regulatory oversight
• Hypotheticals
• Lessons learned and recommendations

• Common uses of chronic care management (CCM), transitional care management (TCM), remote physiologic monitoring (RPM), and remote therapeutic monitoring (RTM)
• Medicare reimbursement standards and issues for care CCM, TCM, RPM, and RTM
• Structures for collaborations among health care providers, practitioners, IT/digital health vendors, consultants, clinical staffing companies, and management companies
• Contracting considerations in structuring collaborative care management, RPM, and RTM arrangements
• Compliance concerns relating to care management, RPM, and RTM

To kick off the session, speakers will provide a brief overview of the key drivers for health policy in the United States and the policy process. They will then dive into current health policy issues, challenges and considerations facing stakeholders in the health care ecosystem, including hospitals, health systems and physicians. Throughout this session, speakers will provide case studies for how you may advocate for policies that benefit your clients. Attendees will leave understanding:

• Key drivers for health policy in the United States
• Health policy issues and considerations currently in play and the impact they have on hospitals, health systems, and physicians
• Ways in which attorneys can influence policy on behalf of their clients

• Data universe
• Data movement, processing, and retention
• Legal and regulatory authority; liability for providers and other actors
• Patient and provider initiated sharing of PHI
• Case examples

• Antitrust refresher
• Top 10 antitrust issues for a health care GC or Generalist
• Update from DC: Navigating today’s changing landscape
• Ask me anything–Lightning Round

Health systems are in the process of digital transformation and are using a combination of internally developed, jointly developed (e.g. with third parties through joint ventures and pilot programs) and commercially available technologies. Each of these approaches can present regulatory issues and operational challenges, particularly if the technologies have a patient-facing component, including:
 

• Vendor evaluation and engagement processes
• Privacy and security of health information
• Compliance with Medicare Conditions of Participation and The Joint Commission standards
• Patient and consumer rights
• Human research requirements–drawing the line between research and product evaluation
• Interoperability of technologies
• FDA regulation of developed software
• Relationships that implicate fraud and abuse laws
• Risk management and appropriate clinical review of digital tools offered to patients
• Diversity, inclusion, and health equity considerations

The program–featuring experienced government, defense, and relator’s counsel–will spotlight select False Claims Act investigations, litigations, and settlements pertinent to hospitals and physicians in 2022. The panel will focus on sharing practical tips for handling these matters and will also address expectations for enforcement priorities and risk areas in 2023. Topics include:
 

• Recap of focus areas of enforcement specific to physicians and hospitals in 2022
• Recent settlements, judicial decisions and regulatory changes that may impact False Claims Act enforcement in 2023
• Insights and practical tips, using “real world” examples, for handling both investigations and FCA litigation
• Risk and compliance areas for 2023

• The Private Equity Business Model
• Why are private equity firms interested in medicine?
• The typical terms of a Private Equity Deal
• Regulatory issues presented by private equity deals
• Legal traps and how to avoid them
• What does the influx of private equity mean for physicians and other health care providers?
• Practical advice and tips in advising clients

• Case study of a deal gone awry including next steps for growth, potential self-disclosures, repayments and claims
• The Morning After: Escrows, R&W Insurance, root cause analysis, audits, and policies and procedures
• Collateral Damage: How to handle employees, contractors, and vendors that may have been caught up in the issue
• Post Mortem: Avoiding missteps through contract review, security assessments, billing trend assessments, and coding and documentation review
• Lessons learned from successes and fiascos, actionable pointers, and a few tools to make it all work

• Role of Advance Practice Providers (APPs) on the medical staff, including physician oversight, credentialing, and privileges
• Can APPs be members of a medical staff equal to physicians • Limitations on APPs by State law
• Federal Regulations and their intersection with State Boards of Nursing and Physicians
• Identify Fraud and Abuse/Stark risks when utilizing hospital-employed (or independent) APPs to support inpatient service lines (including surgical service lines)
• Pro Fee Billing by APPs and physicians who share a patient (within the same group or not)
• Practical tips, "do's and don'ts" for optimizing operational and patient care goals and limiting compliance risk

• The Information Blocking Rule: Requirements and exceptions
• Compliance with the IB Rule was not intended to eliminate information protection
• Why most organizations are still not compliant with the IB Rule
• The impact of the October 6, 2022 compliance date
• Where it is at and what it means

• The prior year’s court cases, regulatory actions, and other developments of note for physician and other healthcare transaction reviews
• Our opinion of the top ten issues of concern and what counsel, compliance officers, and consultants need to know about them
• A recap of the major issues of the past decade and how they compare to the past year, including recurring themes and what has changed or remained the same
• Our outlook, tips, and takeaways for navigating trouble spots efficiently and effectively in 2023

• Antitrust refresher
• Top 10 antitrust issues for a health care GC or Generalist
• Update from DC: Navigating today’s changing landscape
• Ask me anything–Lightning Round

Health systems are in the process of digital transformation and are using a combination of internally developed, jointly developed (e.g. with third parties through joint ventures and pilot programs) and commercially available technologies. Each of these approaches can present regulatory issues and operational challenges, particularly if the technologies have a patient-facing component, including:
 

• Vendor evaluation and engagement processes
• Privacy and security of health information
• Compliance with Medicare Conditions of Participation and The Joint Commission standards
• Patient and consumer rights
• Human research requirements–drawing the line between research and product evaluation
• Interoperability of technologies
• FDA regulation of developed software
• Relationships that implicate fraud and abuse laws
• Risk management and appropriate clinical review of digital tools offered to patients
• Diversity, inclusion, and health equity considerations

The program–featuring experienced government, defense, and relator’s counsel–will spotlight select False Claims Act investigations, litigations, and settlements pertinent to hospitals and physicians in 2022. The panel will focus on sharing practical tips for handling these matters and will also address expectations for enforcement priorities and risk areas in 2023. Topics include:
 

• Recap of focus areas of enforcement specific to physicians and hospitals in 2022
• Recent settlements, judicial decisions and regulatory changes that may impact False Claims Act enforcement in 2023
• Insights and practical tips, using “real world” examples, for handling both investigations and FCA litigation
• Risk and compliance areas for 2023

This session will provide an overview of latest developments in the legal landscape for providers of mental health and substance use disorder treatment. Specifically:
 

• Summary of significant changes for BH providers in the 2023 Medicare Physician Fee Schedule
• Telehealth changes for BH providers
• Latest in medication assisted treatment for opioid use disorders
• Emerging issues (e.g., psychedelics, digital health
• Deal landscape: PE, JV, other hot transaction models

• Alternatives to self-reporting: Compliant Stark Resolutions
• Value based arrangements and issues where you can fall outside of compliance
• Fair market value and commercial reasonableness issues–defensibility is the issue

• The drug purchasing eco-system, both for self-administered retail drugs and for infused specialty drugs
• The changes in the laws regarding Medicare payment and how that will affect hospital bottom lines
• Update on CMS’s implementation of the Supreme Court decision on reimbursement of 340B purchased drugs and next steps
• The status of the 340B contract pharmacy litigation and next steps
• Opportunities to partner with drug manufacturers for value-based arrangements

• The bases for risk from quality failures: From COPs, to quality reporting, P4P, VBA-VBE and more
• Types of quality failures that could lead to ‘fraud’: From waste, to EMTALA, mis-utilization, medical necessity, QIO review, false reporting, to implied false claims
• Penalties including termination, exclusions, CMPs, CIAs
• Specific advice the government offers and what it means
• What to do
• This presentation has information for hospitals and physicians as well as some information even for SNFs

• The rules of the road–understanding bylaws’ fair hearing provisions
• Too much or just enough–should you really present that witness or document?
• It drives me crazy when they do that–how to make friends (or at least avoid making enemies)
• Dealing with surprises–if you’ve seen one, you’ve seen one Peer-review hearings are high-stakes events for both the physician and the facility, with reputations and livelihoods on the line. This session will examine key issues, common problems, and practice pointers from the perspectives of both advocate counsel and hearing officer. Whether your practice currently involves either of these roles or you are considering adding them to the services you offer, knowing what the other lawyers in the room know can help maximize your effectiveness.

Health lawyers and stakeholders who are tasked with ensuring Hospital-Physician transactions are effective, successful, compliant, and defensible have a checklist of items to consider. This session is intended to provide a practical guide to what items should be on your checklist, including updates for recent volatility in market and legal landscape. Hypothetical examples will be presented to illustrate how to address common issues with checklist items. Some examples of recent checklist items we will cover (with examples) include:
 

• Shortage of physicians–how to handle shortages and corresponding spikes in fair market value compensation rates
• Patient volume fluctuations–is your transaction prepared for normal and abnormal swings in patient volumes
• MPFS changes–how does this impact compensation rates and compliance
• Stark and AKS changes–what are the practical must do’s to comply with the regulatory changes
• Value-based incentives–how to ensure these are effective and compliant
• Telehealth–how to ensure agreements reflect what is really happening and remain compliant

• Examples of financial relationships between attorney and health care client
• Ethical rules impacting financial relationships with clients
• Judicial and regulatory oversight
• Hypotheticals
• Lessons learned and recommendations

• The bases for risk from quality failures: From COPs, to quality reporting, P4P, VBA-VBE and more
• Types of quality failures that could lead to ‘fraud’: From waste, to EMTALA, mis-utilization, medical necessity, QIO review, false reporting, to implied false claims
• Penalties including termination, exclusions, CMPs, CIAs
• Specific advice the government offers and what it means
• What to do
• This presentation has information for hospitals and physicians as well as some information even for SNFs

• Common uses of chronic care management (CCM), transitional care management (TCM), remote physiologic monitoring (RPM), and remote therapeutic monitoring (RTM)
• Medicare reimbursement standards and issues for care CCM, TCM, RPM, and RTM
• Structures for collaborations among health care providers, practitioners, IT/digital health vendors, consultants, clinical staffing companies, and management companies
• Contracting considerations in structuring collaborative care management, RPM, and RTM arrangements
• Compliance concerns relating to care management, RPM, and RTM

• Role of Advance Practice Providers (APPs) on the medical staff, including physician oversight, credentialing, and privileges
• Can APPs be members of a medical staff equal to physicians • Limitations on APPs by State law
• Federal Regulations and their intersection with State Boards of Nursing and Physicians
• Identify Fraud and Abuse/Stark risks when utilizing hospital-employed (or independent) APPs to support inpatient service lines (including surgical service lines)
• Pro Fee Billing by APPs and physicians who share a patient (within the same group or not)
• Practical tips, "do's and don'ts" for optimizing operational and patient care goals and limiting compliance risk

• Alternatives to self-reporting: Compliant Stark Resolutions
• Value based arrangements and issues where you can fall outside of compliance
• Fair market value and commercial reasonableness issues–defensibility is the issue

• The Information Blocking Rule: Requirements and exceptions
• Compliance with the IB Rule was not intended to eliminate information protection
• Why most organizations are still not compliant with the IB Rule
• The impact of the October 6, 2022 compliance date
• Where it is at and what it means

• The drug purchasing eco-system, both for self-administered retail drugs and for infused specialty drugs
• The changes in the laws regarding Medicare payment and how that will affect hospital bottom lines
• Update on CMS’s implementation of the Supreme Court decision on reimbursement of 340B purchased drugs and next steps
• The status of the 340B contract pharmacy litigation and next steps
• Opportunities to partner with drug manufacturers for value-based arrangements

Health lawyers and stakeholders who are tasked with ensuring Hospital-Physician transactions are effective, successful, compliant, and defensible have a checklist of items to consider. This session is intended to provide a practical guide to what items should be on your checklist, including updates for recent volatility in market and legal landscape. Hypothetical examples will be presented to illustrate how to address common issues with checklist items. Some examples of recent checklist items we will cover (with examples) include:
 

• Shortage of physicians–how to handle shortages and corresponding spikes in fair market value compensation rates
• Patient volume fluctuations–is your transaction prepared for normal and abnormal swings in patient volumes
• MPFS changes–how does this impact compensation rates and compliance
• Stark and AKS changes–what are the practical must do’s to comply with the regulatory changes
• Value-based incentives–how to ensure these are effective and compliant
• Telehealth–how to ensure agreements reflect what is really happening and remain compliant