Schedule

• The ever-changing technology landscape: Generative AI in the practice of health law, machine learning, advance/changes in telehealth

• Economic pressures/financial distress in the US health care sector

• Health Care Employment Law Issues

• Reproductive health care and gender affirming care challenges

• Health care in underserved communities/health equity disparities and initiatives to address

• Criminal Law in Health Care: False Claims Act/Health Care Fraud, education/certification fraud, criminal liability for medical errors, etc.

• The difference between Medicare Parts A-D, including how the programs work for beneficiaries and providers/suppliers, and what coverage and reimbursement is available for items/services

• Medicare governance and structure - CMS and Medicare Contractors, and what regulations and guidance apply 

• Medicare Parts A and B Conditions of Participation and Payment

• How to enroll, maintain participation in, and get paid by Parts A and B

• Managed care and the role of eligibility, benefits, provider networks, and financing in Parts C and D

• Hot Topics in Medicare Parts A-D

• The Medicaid program and its program objectives

• Medicaid financing and governance

• Medicaid fee-for-service and Medicaid managed care

• The common “bones” of Medicaid programs and how they differ

• Fundamental issues in Medicaid (enrollment, credentialing, reimbursement, compliance)

• How to research Medicaid issues

Privacy is becoming one of the core areas for understanding in virtually all areas of health law. Privacy affects most health care policy issues, corporate transactions, business contracts, litigation, business strategy and a wide range of overall compliance issues. This session will provide a baseline for all health care professionals on key areas where health privacy law impacts the business of health care and the use of health information across our health care system.

When first introduced to health law, even the most seasoned attorneys struggle to get up to speed on the multitude of unique legal resources consulted in this area of practice. In this hands-on session, participants will research and utilize fundamental health law sources (e.g., CMS conditions of participation; state operation manuals; survey interpretive guidelines; agency work plans, budgets, and guidance; accreditation standards; deficiencies; health association policy statements; codes of ethics) in tandem with traditional legal resources (e.g., caselaw, statutes, regulations) to work through complex health care scenarios.

• Recognize the role that specific health law research sources play in responding to regulatory issues

• Conduct appropriate legal research necessary to respond to a legal and ethical issue in practice

• After consulting various legal resources, be able to recommend an appropriate course of action

• An introduction to the Physician Self-Referral Law (PSL), including its legislative and regulatory history

• Key terminology of the PSL

• Exceptions to the PSL’s prohibitions and how to use them effectively

• PSL precautions and practitioner tips

• Anti-Kickback Statute

  • Safe harbor regulations

  • Advisory opinions and other guidance

  • Enforcement and significant cases

• Eliminating Kickbacks in Recovery Act (EKRA)

• Compliance considerations

• Overview of the False Claims Act

• Recent developments and updates in False Claims Act cases and jurisprudence

• OIG Work Plan and other Compliance Issues that are targets of government investigations

• Advising clients on best practices for responding to investigations and defending against False Claims Act cases

There has been significant discussion in the legal field about sponsorship, mentorship and why both are critical to success for all attorneys. In this session, speakers will discuss the benefits of having a sponsor and mentor as an attorney practicing in a variety of settings and how each can impact an attorney’s career development. In addition, speakers will address the role of sponsors, protégés, mentors and mentees and highlight how to foster and grow these relationships. They will share their own real-life experiences of serving as sponsors, protégés, mentors and mentees.

• The differences between sponsorship and mentorship and define the roles of a sponsor, protégé, mentor and mentee

• The benefits of having both a mentor and a sponsor throughout an attorney’s career

• Guidance for attorneys to find, build and grow these relationships

• How these relationships can change and evolve over time

During this session, speakers will provide an overview of the key drivers for health policy in the United States, including increasing health care costs. They will then dive into the policy process and provide case studies for how attorneys may impact policy at the federal level throughout their careers. Speakers will also discuss current health policy issues, challenges and considerations facing stakeholders in the health care ecosystem.

• The key drivers for health policy in the United States

• The basics of the policy process and key ways in which attorneys can influence policy on behalf of their clients

• Key health policy issues and considerations currently in play and the impact they have on key health care stakeholders

This presentation will introduce attendees to some of the common health care regulatory issues that arise when advising physician practices. Topics that will be addressed include:

• The corporate practice of medicine, management services arrangements and fee structures

• Key terms in physician employment or independent contractor agreements (including term and termination, non-solicitation, non-competition, malpractice insurance, and records completion standards)

• Payer credentialing (including timelines, locums exceptions, reassignment of billing rights)

• The Stark Law and commonly used exceptions (including in-office ancillary services + group practice, bona fide employment, and lease of space/equipment)

• Federal Anti-Kickback Statute and state fee-splitting law considerations

• Use of nonphysicians in physician clinics (licensing, scope of practice, and collaboration/supervision)

• Compliance Program design and implementation considerations

• The Government's focus on Compliance Program effectiveness

• The Board's role in compliance

• Distinguishing the role of Legal and Compliance in compliance matters

Using real world hypotheticals in an interactive discussion, this panel will cover key areas that every health care lawyer should be aware of when advising a behavioral health client, including:

• The importance of integration of behavioral health in various care settings

• Licensure of behavioral health facilities and professionals

• Behavioral health privacy regulations and their relationship with HIPAA

• The Eliminating Kickbacks in Recovery Act and its relationship with healthcare fraud and abuse laws

• The impact and implementation of mental health parity and addiction equity laws

• Special considerations related to tele-behavioral health, including prescription of controlled substances

2023 brought with it a new, challenging market for health care startups: They have to meet the same lofty innovation goals with fewer resources. The natural tension between tech startup culture (move fast, break things) and health care (proceed with caution through myriad regulatory hurdles) has also grown more complex with increased regulatory and media scrutiny in the last year. The result: In-house counsel at digital health and telemedicine startups face their toughest challenge yet.

In this talk, two senior in-house health care advisors team up to share strategies for working through these challenges to set both the business and patients up for success. In-house healthcare counsel in this climate increasingly need to learn to actually hit fastballs thrown at them–to work with speed and accuracy. This session will address:

• Laying out common problems high-growth health care startups face and how to tackle them with efficiency in this new market (both in DTC and B2B spaces)

• Methods for providing actionable advice in "gray areas" (anticipating where laws will go and making risk calls)

• Methods for providing actionable advice to blended clinical + business teams

• Strategies to counsel with excellence on fewer resources

• Suggestions for addressing novel AI use cases in health care organizations

• Tips for handling privileges when working with increasingly hybrid health care business teams

This session explores the regulatory framework governing the U.S. private or commercial health insurance market and managed care arrangements.

• Commercial health insurance overview: Explaining the key concepts you need to know

• The commercial health insurance market: Breaking down the major components of the health insurance industry

• Regulation of commercial health insurance: Surveying the primary state and federal laws regulating insurance

• Managed care arrangements: Understanding the purpose of managed care and how it is regulated and delivered

• Applicable statutes, regulations, and accreditation requirements for hospital medical staffs

• Underlying legal, business and operational issues for hospital medical staffs

• Emerging issues and areas of emphasis, including:

  • Medical staff/employed physician considerations at hospitals

  • Integrating non-physician Advanced Practice Professionals

  • Information sharing

  • Trends in Medical Staff governance and oversight

  • Drafting tips and sample language for hospitals

• Difference between the Investor (PE/VC firm) and the Company/Organization it wants to invest in...scenarios will be added, who's who in the legal

• Ethics re: Representing the Board of Directors of the Company and CEO of the company

• Ethics re: Disclosures to potential PE/VC Investors whether you are in-house or outside counsel representing the Company

• Ethics of when the Investor or Company says "Make this Deal Happen"

• Telehealth, digital health, and artificial intelligence in health care

• Telehealth, digital health, and AI industry regulators and applicable laws

• Structures and models

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

• Enforcement actions, trends, and the HHS OIG Special Fraud Alert on Telehealth

• A framework for health, health equity, and health justice; the role of social and structural drivers of health

• The impact of law and policy on health equity throughout history

• Current initiatives to advance health equity; overview of resources

• Collaboration and the roles of physicians and other health care professional, hospitals/health systems, and payers

• Action steps for the legal community

Using a hypothetical health care client situation, apply fundamental learnings from other conference sessions by:

• Walking through the lifecycle of a deal from initial stages of interest through post-closing integration

• Practical guidance for addressing critical path items common in negotiations

• Best practices for addressing Stark Law and other regulatory issues identified in due diligence

• How business and regulatory issues that unfolded during the transaction process are resolved through definitive agreements and post-closing actions

• Core requirements for health care organizations to qualify as charitable under Code Section 501(c)(3)

• Restrictions on improper benefits to third parties

• Limitations on political activities, including lobbying and political campaigning

• Classification as a public charity or a private foundation—and the consequences

• Taxation of unrelated business activities

• Additional requirements for charitable hospitals under Code Section 501(r)

• Post Acute Care: What is it?

• Alphabet Soup of Post-Acute Care

• Overview of Licensure and certification

• Comparative Survey Process across industry types

• Funding mechanisms and Compliance Issues for post-acute care

• Governmental Audits and Compliance

• Fraud and Abuse concerns

• Special problems and trends impacting post-acute providers

This session explores the regulatory framework governing the U.S. private or commercial health insurance market and managed care arrangements.

• Commercial health insurance overview: Explaining the key concepts you need to know

• The commercial health insurance market: Breaking down the major components of the health insurance industry

• Regulation of commercial health insurance: Surveying the primary state and federal laws regulating insurance

• Managed care arrangements: Understanding the purpose of managed care and how it is regulated and delivered

This presentation will focus on spotting and understanding labor and employment issues. Using a series of humorous film clips, topics to be covered will include:

• Employment-at-Will and Wrongful Discharge

• Title VII, the ADA and the FMLA

• Traditional Labor Law

• Wage and Hour

• Performance Management

• Difference between the Investor (PE/VC firm) and the Company/Organization it wants to invest in...scenarios will be added, who's who in the legal

• Ethics re: Representing the Board of Directors of the Company and CEO of the company

• Ethics re: Disclosures to potential PE/VC Investors whether you are in-house or outside counsel representing the Company

• Ethics of when the Investor or Company says "Make this Deal Happen"

• Telehealth, digital health, and artificial intelligence in health care

• Telehealth, digital health, and AI industry regulators and applicable laws

• Structures and models

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

• Enforcement actions, trends, and the HHS OIG Special Fraud Alert on Telehealth

This presentation will introduce attendees to some of the common health care regulatory issues that arise when advising physician practices. Topics that will be addressed include:

• The corporate practice of medicine, management services arrangements and fee structures

• Key terms in physician employment or independent contractor agreements (including term and termination, non-solicitation, non-competition, malpractice insurance, and records completion standards)

• Payer credentialing (including timelines, locums exceptions, reassignment of billing rights)

• The Stark Law and commonly used exceptions (including in-office ancillary services + group practice, bona fide employment, and lease of space/equipment)

• Federal Anti-Kickback Statute and state fee-splitting law considerations

• Use of nonphysicians in physician clinics (licensing, scope of practice, and collaboration/supervision)

• Compliance Program design and implementation considerations

• The Government's focus on Compliance Program effectiveness

• The Board's role in compliance

• Distinguishing the role of Legal and Compliance in compliance matters