Schedule

Join AHLA’s President and EVP/CEO to hear about the State of the Association. The newly elected Fellows will be introduced. In addition, President Shorter will present the David J. Greenburg Founders Award, the Association’s highest and most prestigious award presented to an individual who has demonstrated exceptional qualities of leadership and sustained loyalty and service to AHLA throughout their career.

Gathering on the Left Coast, our speakers will strive to get it Right covering key developments over the past year as well as identifying 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
• New labor and employment challenges
• And much more!

It is 2:00am on a Sunday morning and you get a call telling you that your servers have been disabled, patient data seized, and it will cost $5 million to get it back. What do you do?

• Hear directly from General Counsels that have experienced a ransomware attack
• How did they respond to this crisis?
• What steps did they take to remain operational?
• How did they negotiate a resolution?
• What lessons were learned to better prepare yourself for an attack in the future?

• Parity provisions in the year-end Consolidated Appropriations Act, 2023
• DOL/IRS/HHS parity investigations and reports to Congress per Consolidations Appropriations Act, 2021
• Tri-Agency Parity Rulemaking/DOL self--compliance tool and efforts to provide better clarity regarding nonquantitative treatment limitations (NQTLs)
• National Association of Insurance Commissioners' work in parity space
• Case studies of examples of how lawyers can approach MHPAEA
• Legislation to expand MHPAEA to other coverage (e.g., Medicare)

• Introduction to the U.S. Food and Drug Administration (FDA), including agency organization, jurisdiction, and applicable legal authorities (e.g., FDCA, PHSA)
• How FDA regulates medical devices and pharmaceuticals (including small molecule drugs and biologics): What is the process for bringing a new product to market? Who is responsible for meeting certain pre- and post-market requirements?
• Application of foundational health regulatory principles to provider arrangements with manufacturers, such as reimbursement, fraud and abuse, antitrust and privacy / security: How do these critical concepts apply in the context of provider arrangements with the device and pharmaceutical industries?
• Provider participation in research and clinical trials: What are the roles and responsibilities of clinical investigators? What are the differences between Compassionate Use (Expanded Access) and Right to Try?
• Current hot topics, including physician development of medical devices in-house and how these activities are regulated. For example, this issue took on new importance in response to the Covid-19 pandemic and increased use by FDA of its Emergency Use Authorization (EUA) authority. However, many novel areas remain, including proliferation of 3D printing technology to build devices at the point of care as well as laboratory developed tests (LDTs) and the potential enactment of the VALID Act

• Why are health insurers and health systems entering into innovative insurance joint ventures?
• Specific benefits to each partner
• Three fundamental structures
  • Contractual JV
  • Legal Entity JV
  • Hybrid JV
• Focusing the joint venture on growth
• How value-based contracting is driving collaboration across the value chain
• Developing and aligning the incentives for each partner in the joint venture
• Redesigning the health system to focus on value-based growth

This session will explore key legal developments and provide innovative, practical tips for employers to minimize legal risks as changes in the industry and workplace are creating new discrimination, harassment and wage and hour challenges for employers. Topics will include how:

• The prevalence of remote employees has made certain Americans with Disabilities Act accommodation claims more difficult to defend, highlights wage and hour vulnerabilities, and makes off-premises, outside work-hour harassment claims the norm
• As employers rely more heavily on alternative staffing models (such as travel nurses), they are facing increased exposure for wage and hour claims such as travel time, overtime/regular rate violations for per diems, and more
• The new delivery models for health care services, such as retail health and telemedicine, are creating new challenges
• As more states permit and protect the use of medical and recreational cannabis, employers are at risk for news claims for discrimination and accommodations
• An increasing focus on diversity, equity, and inclusion in the workforce may impact an employer’s risk of being sued for discriminatory hiring or training

This course is intended for all cool cats who dig ethics; a modern jazz based primer on could I, should I would I for health lawyers. Topics covered include:

• Who is my client, Stan? Is it the Girl from Ipanema, her boss, or her board of directors?
• At Last, Etta-I can't limit the scope of my representation the way that you'd like (or can i?)
• What a Wonderful World it Would Be if you would take my advice and not tell me you plan to defraud investors, Louis
• It Don't Mean A Thing (if it ain't explained in writing, in triplicate, in our retention agreement), Duke
• Some Day My Prince Will Come, Miles ... but until then, can I represent this client?

• State Law Peer Review, PSQIA, and HCQIA Protections: What Do They Mean?
• Authority and Responsibility of Compliance v. Medical Staff
• Peer Review Documentation and Potential False Claims Act, Anti-Kickback, Stark, and Civil Monetary Penalty Claims
• Resolution Options and Recommendations

• FTC developments/proposed rulemaking
• Physician Non-compete agreements generally/policy implications
• Jurisdiction issues (certain states prohibit the use of non-compete agreements with physicians)

• FCA cases pending before Supreme Court and potential impact of those cases on FCA jurisprudence
• The extent to which whether a company has a reasonable interpretation of law provides a viable defense to an FCA action
• Latest circuit court decisions regarding the extent to which plaintiff must prove that the alleged unlawful remuneration was the cause of referral to bring a successful FCA / AKS lawsuit
• Latest FCA lawsuits discussing the level of proof plaintiff must establish to show alleged false statement or claim was material to the government’s payment decision
• When the FCA requires that companies must remit an overpayment or be held liable under the FCA

• 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
• 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

• Competitive concerns and theories of harm surrounding the so-called cross-market mergers involving health systems
• Economics and business strategies underlying vertical mergers in health care
• Interplay between competition and innovation in non-horizontal healthcare combinations and transactions
• Pending enforcement and regulatory initiatives, including recent merger challenges in health care and the awaited issuance of new merger guidelines

• This session will address one of the biggest developments in Behavioral Health for 2023–new regulations under 42 C.F.R. Part 2 (Part 2), and progress and prospects for enforcement
• The Confidentiality of Substance Use Disorder Patient Records requirements under Part 2 must be amended to incorporate groundbreaking legislation under the CURES Act more closely aligning the stringent requirements for SUD patient records with the streamlined HIPAA requirements
• Multiple unprecedented changes are in store for Part 2 including anti-discrimination provisions, loosening of protections to align more closely with HIPAA, heightened barriers for use in proceedings, and modifications to Part 2’s traditional downstream application to non-Part 2 providers and payers

• Analytic Trackers 101 and Core Marketing Principles
• A look at the data that is transmitted, including by who and how
• State and federal regulators’ specific concerns, including post-Dobbs and privacy concerns, and guidance
• Class action litigation theories of liability
• Regulatory and class action defense
• Recommendations

• Effective Clinical Decision Support (“CDS”) Tools
• Potential benefits to providers and patients
• Recent enforcement actions highlight key fraud and abuse risks
• Regulatory challenges for new and developing CDS Tools
• Common pitfalls in implementation and operation of CDS Tools

• The role of internal Legal Departments in supporting the Chief Compliance Officer’s (CCO’s) efforts in meeting the CIA’s requirements
• How to effectively use outside Legal Counsel
• The roles of the Compliance Committee and Board in supporting and overseeing the use of legal counsel
• Recommendations on when to conduct investigations under privilege
• Hypotheticals to illustrate the best way to advise clients on the effective use of Legal Counsel throughout the life of a CIA

• Introduction to AI and Health Equity
  • What is artificial intelligence and machine learning (AI/ML)
  • Health equity and the challenges of advancing health equity through the Social Determinants of Health (SDOH)
• Global Legal landscape–Representative Approaches
  • World Health Organization (WHO) AI ethics guidance
  • Developing Countries Perspective (Africa)
  • Equity/Patient Centered Approaches (Canada, Australia/New Zealand)
  • Balancing Innovation and Consumer Protection (United States)
  • Emerging Leadership in AI Regulation (European Union)
  • Different Approaches (United Kingdom, Asia)
• The Intersection of AI and Health Equity
  • The critical role of data quality and representativeness for health equity
  • AI/ML regulations that support accountability and include the voices necessary to address global health disparities

• 2021, 2022 and 2023 have seen significant antitrust activity and increased and coordinated enforcement focus by government entities in the health care field, particularly in regard to hospitals, providers, and insurers
• Both on the enforcement and private litigation side, the court and regulators provided interesting and important decisions that could impact the health care industry for years to come
• Merger decisions, including non-traditional merger challenges, and enforcement focus on competition, consolidation, and state actors all have contributed to a changed landscape
• The presentation will provide a survey of, and analysis and insight into, antitrust decisions that shaped our current antitrust landscape

• The home health and hospice focus areas identified in the OIG Work Plan
• The increased scrutiny of home health and hospice, especially the focus on new providers
• The recently implemented hospice survey enforcement actions and soon to be implemented Special Focus Program, as well as MedPac’s new project to analyze lifetime hospice length of stay
• OIG updates and recommendations with respect to hospice compliance
• Recent government enforcement examples
• Audit and compliance strategies and practice tips for home health agencies and hospices to weather through the audit, survey and enforcement storm

• New developments in the community benefit requirement. Analyze recent news articles and studies on hospital community benefits, the value of tax-exemption, the IRS’s view that community benefit activities may give rise to UBI, and ways to potentially better quantify the value of an organization’s community benefit on the Form 990
• IRS audit areas of focus based on IRS work plan and recent experience. Issues include UBI silo rules, challenging NOLs/documentation of business purpose, definition of a “trade or business” for UBI loss purposes, and ERTC claims
• Inflation Reduction Act credits, including direct pay credits available to hospitals. We will also address common structures, traps for the unwary, and state tax issues for transactions involving exempt organizations and the development of solar projects
• ESG, its impact on healthcare organizations, relation to IRC 501(r), and recent state laws on the issue
• Any major federal or state tax developments occurring between now and our presentation date

• What strategies can be adopted and used to improve the pipeline by getting more individuals of color to go to college, be interested in (and having the opportunity in) becoming a lawyer?
• What can law firms do to make sure that attorneys of color are not only hired … but actually set up for success?
• How can we better mentor and sponsor attorneys of color in their careers?
• While many corporate counsel/in-house departments are making demands of law firms to improve diversity, what and how can law firms and corporations partner together to CREATE opportunities to hire and promote diversity throughout the legal profession?
• What do organizations’ Chief Diversity Officers need in order to be successful?

• ONC will provide a brief overview of the information blocking regulations (45 Part 171), including their relationship to the HIPAA rules
• ONC will discuss information blocking guidance and/or resources issued in the past year
• ONC will discuss new information blocking proposals included in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Proposed Rule
• OIG will provide updates related to the information blocking enforcement regulations and any additional guidance or materials
• OIG will share practical information and tips about next steps related to investigations, civil monetary penalties, and settlements

• The evolution of fiduciary duties post-pandemic
• Implications of these changes
• Balancing governance and management in today's economy
• Contending with social movements and labor trends

Private equity investment in physician practices is at an all-time high and is focused on specialties that are essential to the bottom line and mission of health systems. This session examines challenges hospitals face when competing or contracting with PE and presents novel collaboration models between hospitals, private equity and physicians.

• PE deals. Brief overview of emerging PE -physician investments–and the challenges/opportunities for hospitals
• Strategic risk. Key strategic risk areas for health systems
• Regulatory traps. Re-examining existing physician–hospital arrangements when the physician group is acquired; Structuring the new financial deal
• Complex collaborations. Case studies on contracting and integration models (co-management arrangements, ASC joint ventures, service line collaborations and others)

• Telehealth state licensing and federal regulatory issues prior to, during, and after COVID-19
• Operational and ethical challenges with compliance with the letter of the law
• Practical recommendations for providers struggling to comply with the letter of the law and their ethical obligations, based on UCSF’s recommendations to physicians

This session will focus on whether and how health care providers are taking risk and the fraud and abuse related regulatory issues that come into play in structuring these arrangements. The session will go beyond the language of the value-based care Stark and Anti-kickback regulations to apply them and discuss if and how they are being utilized by health care innovators to implement value-based payment programs. It is designed for those who have read the rules but are not sure how to actually put them into use. We will address the following:

• Whether the value-based exceptions and safe harbors are being put to use, who is using them, and what practical challenges have arisen from trying to fit arrangements within the exceptions and safe harbors
• Hypotheticals addressing how these exceptions and safe harbors can be applied to real world scenarios
• Alternative alignment strategies outside of using the value-based exceptions and safe harbors
• Other regulatory issues that providers who are taking on risk are facing, such as how to get patients to engage and ways to incentivize positive behaviors within the bounds of the federal fraud and abuse laws

The panel will discuss best practices in managing health care disputes before litigation and during litigation in ADR and the courts. The audience will gain insights from experienced in-house and outside counsel on the following topics:

• Choosing outside counsel and when to bring them into a dispute
• Tools for managing outside counsel including setting expectations, timeliness discipline, and effective communication
• Budgeting and Alternative Fee Structures
• Defining the “Win” or best outcome
• Choosing the forum: ADR v. Courts
• Mitigating the risk of litigation
• Meeting expectations of in-house counsel’s business client
• Tips for drafting ADR clauses that mitigate risk and reduce cost
• Tools to reduce costs during litigation
• Dealing with pattern litigation and difficult opposing counsel
• What makes the in-house-outside relationship different in health care (e.g., challenges with confidentiality, importance of maintaining relationships, regulatory oversight)

• The Dobbs decision, Pre-Roe “Zombie” laws and trigger bans, and the status of State and Federal Law
• EMTALA, Federal Preemption and Guidance, and State Challenges
• Hospitals’ emergency room response to pregnancy complications post-Dobbs including pending litigation
• Medical/legal ethics in emergency settings, transfers, and other considerations

This session will assess the state of health information sharing across the industry more than 2 years after the initial information blocking compliance date, 8 months after the scope of regulated data under the Cures Act Final Rule expanded to all Electronic Health Information, and 2 months after the publication of a new proposed interoperability rule from the HHS Office of the National Coordinator for Health IT. Typically, we think of these regulations through a compliance lens, but these rules also promote the sharing of standardized data in ways that accelerate and enable digital health strategies. Presented by both in-house and outside counsel, this session will address a range of cutting-edge digital health topics, including:

• Understanding USCDI (US Core Data for Interoperability), EHI (Electronic Health Information), APIs, FHIR, and information blocking and what this means for the availability and use of healthcare data, including an overview of proposed changes to the information blocking rules
• Data sharing and marketplace strategies to facilitate interoperability in a trusted, secure, consumer-centric environment
• Opportunities, risks, and mitigation strategies when advising on APIs, apps, and services that “write back” into the electronic health record

This session will explore key legal developments and provide innovative, practical tips for employers to minimize legal risks as changes in the industry and workplace are creating new discrimination, harassment and wage and hour challenges for employers. Topics will include how:

• The prevalence of remote employees has made certain Americans with Disabilities Act accommodation claims more difficult to defend, highlights wage and hour vulnerabilities, and makes off-premises, outside work-hour harassment claims the norm
• As employers rely more heavily on alternative staffing models (such as travel nurses), they are facing increased exposure for wage and hour claims such as travel time, overtime/regular rate violations for per diems, and more
• The new delivery models for health care services, such as retail health and telemedicine, are creating new challenges
• As more states permit and protect the use of medical and recreational cannabis, employers are at risk for news claims for discrimination and accommodations
• An increasing focus on diversity, equity, and inclusion in the workforce may impact an employer’s risk of being sued for discriminatory hiring or training

• State Law Peer Review, PSQIA, and HCQIA Protections: What Do They Mean?
• Authority and Responsibility of Compliance v. Medical Staff
• Peer Review Documentation and Potential False Claims Act, Anti-Kickback, Stark, and Civil Monetary Penalty Claims
• Resolution Options and Recommendations

• This session will address one of the biggest developments in Behavioral Health for 2023–new regulations under 42 C.F.R. Part 2 (Part 2), and progress and prospects for enforcement
• The Confidentiality of Substance Use Disorder Patient Records requirements under Part 2 must be amended to incorporate groundbreaking legislation under the CURES Act more closely aligning the stringent requirements for SUD patient records with the streamlined HIPAA requirements
• Multiple unprecedented changes are in store for Part 2 including anti-discrimination provisions, loosening of protections to align more closely with HIPAA, heightened barriers for use in proceedings, and modifications to Part 2’s traditional downstream application to non-Part 2 providers and payers

• Situations which often result in facility-initiated resident discharge by SNF and AL facilities
• Valid and invalid bases for facility-initiated SNF and AL resident discharges
• What it means to specifically comply with notice and procedural requirements for facility-initiated SNF and AL resident discharges
• Potential strategies to overcome the special problem of difficult SNF and AL facility-initiated resident discharges
• Issues surrounding the "nuclear option" when SNF and AL residents holdover after valid facility-initiated discharge procedures
• Hospital discharge planning: Understanding safe discharge
• Considering options when there is no safe discharge available in the hospital setting
• Transfer and discharges from hospital swing beds
• Liaising between acute and long term care

• A personal story of recovery
• Understanding the biology of stress: What it does to our minds and bodies
• Alcohol and the legal profession: Changing the culture
• What resilient lawyers do differently

Partnerships and joint ventures are an important source of revenue and innovation for many health care organizations, particularly in areas of emerging technology. Our panelists will share insights from their backgrounds in business, valuation, and law and discuss how to best position your joint ventures for success. Topics will include:

• Identifying opportunities for partnership
• Developing and implementing joint ventures
• Enhancing the value of your services
• Valuing unique factors specific to joint ventures
• Discounting for control and marketability
• Remembering key legal tips and tricks, particularly in for-profit and nonprofit joint ventures

• The landscape for future enforcement actions is postured to be aggressive
• There are multiple factors contributing to this, including:
  • A backlog of investigations delayed by COVID
  • A series of investigations inspired by COVID (testing, PPP, etc.)
  • Investigations prompted by the need to recover funds in the aftermath of COVID
• Preparation can minimize and even avoid some of the consequences
• Unmanaged investigations can destabilize health care entities

• Evolution of federal and state laws and regulations from June 2022-June 2023 (e.g., state laws, personhood laws, fetal heartbeat laws, shield laws, telemedicine abortion, FDA, federal abortion law, path to the Supreme Court, etc.)
• Experiences from different stakeholders, including hospitals/health systems, physicians/physician groups, reproductive providers/services, investors, innovators, digital health including FemTech, privacy, health equity
• Application of specific Model Rules of Professional Conduct for lawyers (e.g., Rules 1.2, 1.4, 1.13, 1.16, 2.1 and 2.3) to hypothetical case studies
• Impact of Dobbs on the health industry as a whole, other legislation & the future of women’s health as the conversation evolves from anti-abortion [if anti-abortion is too “strong”, we could replace with reproductive rights] to government involvement in our healthcare decisions
• How the midterm elections have influenced the issues and the potential effect on the 2024 elections

• 2021, 2022 and 2023 have seen significant antitrust activity and increased and coordinated enforcement focus by government entities in the health care field, particularly in regard to hospitals, providers, and insurers
• Both on the enforcement and private litigation side, the court and regulators provided interesting and important decisions that could impact the health care industry for years to come
• Merger decisions, including non-traditional merger challenges, and enforcement focus on competition, consolidation, and state actors all have contributed to a changed landscape
• The presentation will provide a survey of, and analysis and insight into, antitrust decisions that shaped our current antitrust landscape

Insights from a panel of health care attorneys across transactional, antitrust, and regulatory disciplines will include current and anticipated systemic challenges facing the industry. Topics discussed include:

• Balancing heightened anti-trust enforcement with securing meaningful strategic partnerships
• Approaches for consideration as health care entities maneuver transactional competition within the bounds of regulation
• Impact of state health care transaction review laws
• Effects of reimbursement constraints and rising costs that continue to challenge providers
• Affiliation trends and challenges including when they are not successful

The scale and pace of recent transactions confirm that, more than ever, health care data has substantial value to those seeking to discover, improve, and target therapies. Data-driven partnerships are bringing together health care providers and data aggregators, IT analytics vendors, life sciences firms, genomic testing companies, and other innovators in the health care space. We address key challenges for these transactions including:

• Managing increasingly complex deal structures such as consortium models and those involving genomic data
• Addressing compliance with myriad federal and state laws and regulations that may come into play and govern permissible activities of any health care data transaction
• Valuing the data, IP, services, and equity that may be exchanged in these transactions
• Ensuring that pricing is compliant with fair market value considerations

Incorporating defense, government enforcement, and relator bar perspectives, we will address common payor and provider compliance problems related to Medicare Advantage plans and how to prevent these problems from escalating into higher risk audit and compliance issues or full-blown False Claims Act government investigations. More specifically, we will discuss:

• The latest government enforcement trends relating to MA Risk Adjustment
• Ensuring the accuracy, completeness, and truthfulness of diagnosis data submitted to CMS
• Pitfalls to avoid when conducting chart reviews and health risk assessments
• Safeguards to ensure successful collaboration between MA plans, providers, and downstream entities
• Compliance issues on the horizon given the latest regulatory developments, such as utilization review and sales and marketing practices

• Interesting fraud and abuse developments from various perspectives: an attorney representing industry clients, DOJ, and OIG
• Recent priorities and developments in DOJ civil enforcement
• Updates regarding HHS-OIG’s oversight, enforcement, and guidance efforts

Private equity investment in physician practices is at an all-time high and is focused on specialties that are essential to the bottom line and mission of health systems. This session examines challenges hospitals face when competing or contracting with PE and presents novel collaboration models between hospitals, private equity and physicians.

• PE deals. Brief overview of emerging PE -physician investments–and the challenges/opportunities for hospitals
• Strategic risk. Key strategic risk areas for health systems
• Regulatory traps. Re-examining existing physician–hospital arrangements when the physician group is acquired; Structuring the new financial deal
• Complex collaborations. Case studies on contracting and integration models (co-management arrangements, ASC joint ventures, service line collaborations and others)

• Telehealth state licensing and federal regulatory issues prior to, during, and after COVID-19
• Operational and ethical challenges with compliance with the letter of the law
• Practical recommendations for providers struggling to comply with the letter of the law and their ethical obligations, based on UCSF’s recommendations to physicians

This session will focus on whether and how health care providers are taking risk and the fraud and abuse related regulatory issues that come into play in structuring these arrangements. The session will go beyond the language of the value-based care Stark and Anti-kickback regulations to apply them and discuss if and how they are being utilized by health care innovators to implement value-based payment programs. It is designed for those who have read the rules but are not sure how to actually put them into use. We will address the following:

• Whether the value-based exceptions and safe harbors are being put to use, who is using them, and what practical challenges have arisen from trying to fit arrangements within the exceptions and safe harbors
• Hypotheticals addressing how these exceptions and safe harbors can be applied to real world scenarios
• Alternative alignment strategies outside of using the value-based exceptions and safe harbors
• Other regulatory issues that providers who are taking on risk are facing, such as how to get patients to engage and ways to incentivize positive behaviors within the bounds of the federal fraud and abuse laws

• Salary, bonus, and other benefits components of total compensation
• Deferred compensation strategies
• Split-dollar arrangements: Choosing the right strategy and avoiding mistakes in plan design
• Executive bonus strategies and pitfalls
• Non-compensation ideas including sabbaticals
• Challenges in reasonable compensation analysis
• Effective governance strategies for oversight and negotiation

• RPM/RTM Overview–description of services, reimbursement principles, and care models
• RPM/RTM Arrangements–Description of possible arrangements including common contractual provisions
• RPM/RTM Compliance issues–Fraud and abuse and other compliance issues
• RPM/RTM arrangements and the new Anti-Kickback Safe Harbor for patient support tools under a value-based enterprise

The United States is transitioning to a value-based, transparent, interoperable care delivery and financing system. That transition has implications for long-standing managed care practices and processes of prior authorization in the commercial and government program coverage markets.

• How is Congress evolving requirements and expectations for prior authorization (e.g., H.R. 3173 (Improving Seniors Timely Access to Care Act))?
• How is DHHS evolving requirements and expectations for prior authorization?
• How are States evolving requirements and expectations for prior authorization?
• How are industry participants evolving requirements and expectations for prior authorization?
• What do these changing prior authorization requirements and expectations mean for payers, providers and their vendors?

This course is intended for all cool cats who dig ethics; a modern jazz based primer on could I, should I would I for health lawyers. Topics covered include:

• Who is my client, Stan? Is it the Girl from Ipanema, her boss, or her board of directors?
• At Last, Etta-I can't limit the scope of my representation the way that you'd like (or can i?)
• What a Wonderful World it Would Be if you would take my advice and not tell me you plan to defraud investors, Louis
• It Don't Mean A Thing (if it ain't explained in writing, in triplicate, in our retention agreement), Duke
• Some Day My Prince Will Come, Miles ... but until then, can I represent this client?

• 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
• 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 home health and hospice focus areas identified in the OIG Work Plan
• The increased scrutiny of home health and hospice, especially the focus on new providers
• The recently implemented hospice survey enforcement actions and soon to be implemented Special Focus Program, as well as MedPac’s new project to analyze lifetime hospice length of stay
• OIG updates and recommendations with respect to hospice compliance
• Recent government enforcement examples
• Audit and compliance strategies and practice tips for home health agencies and hospices to weather through the audit, survey and enforcement storm

• What is health equity?
• Why is health equity a health care quality imperative?
• Discussion of the importance of Board, CEO & GC as leaders in advancing health equity
• Discussion of The Joint Commission Health Care Equity standards
• What are social determinants of health and how do they relate to health equity?
• What are the regulatory issues that may impact the social determinants of health?
• How are health care organization addressing social determinants of health?

• Federal regulatory compliance framework for analyzing the effective and permissible way to utilize mid-level providers, e.g., NPs, PAs to support inpatient service lines
• There are Fraud and Abuse/Stark risks, which means inherent FCA risks, when things go awry
• Mid-Level support for surgical services, particularly because of Medicare global surgical package, present specific challenges
• Survey of settlements and case law
• Practical tips, "do's and don'ts" for optimizing operational and patient care goals and limiting compliance risk

• ONC will provide a brief overview of the information blocking regulations (45 Part 171), including their relationship to the HIPAA rules
• ONC will discuss information blocking guidance and/or resources issued in the past year
• ONC will discuss new information blocking proposals included in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Proposed Rule
• OIG will provide updates related to the information blocking enforcement regulations and any additional guidance or materials
• OIG will share practical information and tips about next steps related to investigations, civil monetary penalties, and settlements

• The evolution of fiduciary duties post-pandemic
• Implications of these changes
• Balancing governance and management in today's economy
• Contending with social movements and labor trends

Incorporating defense, government enforcement, and relator bar perspectives, we will address common payor and provider compliance problems related to Medicare Advantage plans and how to prevent these problems from escalating into higher risk audit and compliance issues or full-blown False Claims Act government investigations. More specifically, we will discuss:

• The latest government enforcement trends relating to MA Risk Adjustment
• Ensuring the accuracy, completeness, and truthfulness of diagnosis data submitted to CMS
• Pitfalls to avoid when conducting chart reviews and health risk assessments
• Safeguards to ensure successful collaboration between MA plans, providers, and downstream entities
• Compliance issues on the horizon given the latest regulatory developments, such as utilization review and sales and marketing practices

• Interesting fraud and abuse developments from various perspectives: an attorney representing industry clients, DOJ, and OIG
• Recent priorities and developments in DOJ civil enforcement
• Updates regarding HHS-OIG’s oversight, enforcement, and guidance efforts

• Why are health insurers and health systems entering into innovative insurance joint ventures?
• Specific benefits to each partner
• Three fundamental structures
  • Contractual JV
  • Legal Entity JV
  • Hybrid JV
• Focusing the joint venture on growth
• How value-based contracting is driving collaboration across the value chain
• Developing and aligning the incentives for each partner in the joint venture
• Redesigning the health system to focus on value-based growth

• Competitive concerns and theories of harm surrounding the so-called cross-market mergers involving health systems
• Economics and business strategies underlying vertical mergers in health care
• Interplay between competition and innovation in non-horizontal healthcare combinations and transactions
• Pending enforcement and regulatory initiatives, including recent merger challenges in health care and the awaited issuance of new merger guidelines

• Analytic Trackers 101 and Core Marketing Principles
• A look at the data that is transmitted, including by who and how
• State and federal regulators’ specific concerns, including post-Dobbs and privacy concerns, and guidance
• Class action litigation theories of liability
• Regulatory and class action defense
• Recommendations

• Introduction to AI and Health Equity
  • What is artificial intelligence and machine learning (AI/ML)
  • Health equity and the challenges of advancing health equity through the Social Determinants of Health (SDOH)
• Global Legal landscape–Representative Approaches
  • World Health Organization (WHO) AI ethics guidance
  • Developing Countries Perspective (Africa)
  • Equity/Patient Centered Approaches (Canada, Australia/New Zealand)
  • Balancing Innovation and Consumer Protection (United States)
  • Emerging Leadership in AI Regulation (European Union)
  • Different Approaches (United Kingdom, Asia)
• The Intersection of AI and Health Equity
  • The critical role of data quality and representativeness for health equity
  • AI/ML regulations that support accountability and include the voices necessary to address global health disparities

Join and participate in an advanced discussion of:

• The medical staff’s evolution in light of increased physician employment and use of exclusive contracts and physician groups
• The medical staff’s role in response to large acquisitions and increased trend toward unified medical staffs
• Disappearing community hospitals
• Privileging and credentialing lessons learned from COVID
• The two paths of HR and the medical staff peer review process

This session will assess the state of health information sharing across the industry more than 2 years after the initial information blocking compliance date, 8 months after the scope of regulated data under the Cures Act Final Rule expanded to all Electronic Health Information, and 2 months after the publication of a new proposed interoperability rule from the HHS Office of the National Coordinator for Health IT. Typically, we think of these regulations through a compliance lens, but these rules also promote the sharing of standardized data in ways that accelerate and enable digital health strategies. Presented by both in-house and outside counsel, this session will address a range of cutting-edge digital health topics, including:

• Understanding USCDI (US Core Data for Interoperability), EHI (Electronic Health Information), APIs, FHIR, and information blocking and what this means for the availability and use of healthcare data, including an overview of proposed changes to the information blocking rules
• Data sharing and marketplace strategies to facilitate interoperability in a trusted, secure, consumer-centric environment
• Opportunities, risks, and mitigation strategies when advising on APIs, apps, and services that “write back” into the electronic health record

Partnerships and joint ventures are an important source of revenue and innovation for many health care organizations, particularly in areas of emerging technology. Our panelists will share insights from their backgrounds in business, valuation, and law and discuss how to best position your joint ventures for success. Topics will include:

• Identifying opportunities for partnership
• Developing and implementing joint ventures
• Enhancing the value of your services
• Valuing unique factors specific to joint ventures
• Discounting for control and marketability
• Remembering key legal tips and tricks, particularly in for-profit and nonprofit joint ventures

• The landscape for future enforcement actions is postured to be aggressive
• There are multiple factors contributing to this, including:
  • A backlog of investigations delayed by COVID
  • A series of investigations inspired by COVID (testing, PPP, etc.)
  • Investigations prompted by the need to recover funds in the aftermath of COVID
• Preparation can minimize and even avoid some of the consequences
• Unmanaged investigations can destabilize health care entities

• Evolution of federal and state laws and regulations from June 2022-June 2023 (e.g., state laws, personhood laws, fetal heartbeat laws, shield laws, telemedicine abortion, FDA, federal abortion law, path to the Supreme Court, etc.)
• Experiences from different stakeholders, including hospitals/health systems, physicians/physician groups, reproductive providers/services, investors, innovators, digital health including FemTech, privacy, health equity
• Application of specific Model Rules of Professional Conduct for lawyers (e.g., Rules 1.2, 1.4, 1.13, 1.16, 2.1 and 2.3) to hypothetical case studies
• Impact of Dobbs on the health industry as a whole, other legislation & the future of women’s health as the conversation evolves from anti-abortion [if anti-abortion is too “strong”, we could replace with reproductive rights] to government involvement in our healthcare decisions
• How the midterm elections have influenced the issues and the potential effect on the 2024 elections

The United States is transitioning to a value-based, transparent, interoperable care delivery and financing system. That transition has implications for long-standing managed care practices and processes of prior authorization in the commercial and government program coverage markets.

• How is Congress evolving requirements and expectations for prior authorization (e.g., H.R. 3173 (Improving Seniors Timely Access to Care Act))?
• How is DHHS evolving requirements and expectations for prior authorization?
• How are States evolving requirements and expectations for prior authorization?
• How are industry participants evolving requirements and expectations for prior authorization?
• What do these changing prior authorization requirements and expectations mean for payers, providers and their vendors?