Schedule

• State laws (ban v. non-ban states)
• Cross-state practice
• GME requirements
• Options for going out of state
• Research impact/Confidentiality concerns
• University concerns (faculty practice/employee health insurance/student health)

• Legal and risk issues for clinical trial sites in decentralized clinical trials
• The overlap of telemedicine and remote research—prescribing and state licensure
• Considerations when studying digital tools or incorporating digital tools into clinical trials
• Data privacy and security concerns
• Legal’s role in DEI issues in research
• Hot topics from FDA

• How and why stakeholders, including the government, faculty and administrative leadership, are increasingly expecting AMC counsel to support the translation of discoveries into new therapies, vaccines, devices and diagnostics
• The legal and policy issues, including but not limited to COI, that must be navigated by AMC counsel
• Case studies of successful innovation within an AMC
• Specific suggestions for AMC lawyers when dealing with faculty, companies, and research administrators

This session will briefly review recent high-profile prosecutions of health care professionals, with an eye to what lessons they hold for counsel whose hospital and health system clients may someday face similar situations. Among other things, we will discuss:

• Considerations in indemnifying and defending the professional in question
• Whether, when and how the institution may assert applicable privileges (including the medical quality improvement/peer review privilege) to protect documents from production in discovery
• Crisis Management considerations, media communications and efforts to mitigate potential for reputational damage
• Managing expectations of key stakeholders, including the Governing Board, the public, high profile donors, regulatory and accrediting bodies, and law enforcement
• Interplay of professional regulatory and licensing processes with criminal investigative processes
• Advising clients with respect to internal and external communications, and the impact those communications may have on assertions of privilege (including the attorney-client privilege)

• Academic medical centers and teaching hospitals have long relied on the practice of scheduling overlapping surgeries. The practice provides several benefits, including maximizing patient access to care, enhancing physician efficiency, increasing the utilization of operating suites, and facilitating the progressive autonomy of residents and fellows. We will provide an overview of the practice and applicable regulatory authority, including CMS regulations as well as industry guidance
• Although overlapping surgery practices can have multiple positive impacts, government enforcement actions and media scrutiny in this area has increased considerably in the last seven years following a dramatic Boston Globe article regarding Massachusetts General Hospital’s overlapping surgery practices. There have been several significant False Claims Act investigations, settlements, and Office of Inspector General self-disclosures in this area in the last few years which we will discuss
• We will offer unique, first hand perspectives regarding overlapping surgery investigations and internal reviews. In addition to covering legal issues, we will also address challenges and opportunities when reviewing claims and conducting data analysis
• We will also cover proactive compliance strategies for hospitals to mitigate potential risks including with respect to compliance controls, internal audits, policies and practices, training for employees and staff members, and enhancements to informed consent procedures and forms

• Different types of clinical research collaborations, e.g biorepositories, learning health systems
• The legal frameworks that may apply to these collaborations
• How the purpose and scope of collaboration impacts contracting terms and compliance requirements
• How to mitigate risk when collaborations involve multinational parties, both academic and for-profit
• Implications for intellectual property development and attribution
• Sample checklists responsive to legal and regulatory challenges in multinational collaborative projects

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?

• What is health equity?
• Is health equity a check off or an institutional commitment in your community and local hospitals?
• Why is health equity a healthcare quality imperative?
• The new Joint Commission standards on health equity which are effective on January 1, 2023

• Whistleblower focus on NIH grant fraud, overlapping surgery cases, GME fraud issues
• Experienced health care Fraud defense counsel will facilitate a discussion with a leading whistleblower lawyer about the types of issues being brought by whistleblowers, as well as a discussion of how to mitigate exposure through proactive compliance in these subject matter areas
• Pandemic-related enforcement issues such as reporting of compliance with pandemic funding sources, quality of care issues, as well as telehealth errors and overutilization
• Traditional enforcement areas that still remain a focus such as physician arrangements under Stark/AKS, opioid and other drug prescribing patterns, and more traditional billing and coding schemes
• Risk mitigation strategies to be discussed are the types of actions by defendants that are pushing people to become whistleblowers, corporate culture, and thoughts on how to create effective compliance programs to reduce risks

• How and why stakeholders, including the government, faculty and administrative leadership, are increasingly expecting AMC counsel to support the translation of discoveries into new therapies, vaccines, devices and diagnostics
• The legal and policy issues, including but not limited to COI, that must be navigated by AMC counsel
• Case studies of successful innovation within an AMC
• Specific suggestions for AMC lawyers when dealing with faculty, companies, and research administrators

• In the drive to improve performance, hospital networks increasingly seek to engage a range of legacy physician cultures, compensation models, funds flow plans, patient populations, and site locations
• Clinical service is increasing for AMC faculty while teaching duties are expanding to traditionally clinical settings. Meanwhile, academic subspecialties are seen as a resource for disparate, smaller clinical sites
• The compensation arrangements in a AMC/Community physician health system are much more than simply cash compensation to physicians and typically touch on a wide range of clinical, administrative and operational issues
• Focus on the compensation complexities that surface when hybridizing AMC, clinical entities, and medical groups, as well as the necessary cultural, governance, contracting, and funds flows considerations that need to emerge to adequately meet stakeholders’ needs

• AMC telehealth compliance issue spotting
• The telehealth regulatory framework: What was temporarily in place, what is in place currently, and what we anticipate will be in place for the long haul
• Reimbursement considerations–Medicare, Medicaid, Commercial
• Professional board considerations–licensure, scope of practice, supervision with a focus on a state-by-state analysis
• HIPAA and privacy considerations
• Fraud and abuse considerations
• Telehealth and virtual care hot topics and operational considerations for AMCs

• Considerations in indemnifying and defending the professional in question
• Whether, when and how the institution may assert applicable privileges (including the medical quality improvement/peer review privilege) to protect documents from production in discovery
• Crisis Management considerations, media communications and efforts to mitigate potential for reputational damage
• Managing expectations of key stakeholders, including the Governing Board, the public, high profile donors, regulatory and accrediting bodies, and law enforcement
• Interplay of professional regulatory and licensing processes with criminal investigative processes
• Advising clients with respect to internal and external communications, and the impact those communications may have on assertions of privilege (including the attorney-client privilege)

• 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

• AMC telehealth compliance issue spotting
• The telehealth regulatory framework: What was temporarily in place, what is in place currently, and what we anticipate will be in place for the long haul
• Reimbursement considerations–Medicare, Medicaid, Commercial
• Professional board considerations–licensure, scope of practice, supervision with a focus on a state-by-state analysis
• HIPAA and privacy considerations
• Fraud and abuse considerations
• Telehealth and virtual care hot topics and operational considerations for AMCs

• Examples of Financial Relationships between Attorney and Healthcare Client
• Ethical Rules Impacting Financial Relationships with Clients
• Judicial and Regulatory Oversight
• Hypotheticals
• Lessons Learned and Recommendations

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?

• Whistleblower focus on NIH grant fraud, overlapping surgery cases, GME fraud issues
• Experienced health care Fraud defense counsel will facilitate a discussion with a leading whistleblower lawyer about the types of issues being brought by whistleblowers, as well as a discussion of how to mitigate exposure through proactive compliance in these subject matter areas
• Pandemic-related enforcement issues such as reporting of compliance with pandemic funding sources, quality of care issues, as well as telehealth errors and overutilization
• Traditional enforcement areas that still remain a focus such as physician arrangements under Stark/AKS, opioid and other drug prescribing patterns, and more traditional billing and coding schemes
• Risk mitigation strategies to be discussed are the types of actions by defendants that are pushing people to become whistleblowers, corporate culture, and thoughts on how to create effective compliance programs to reduce risks