Schedule

• Medicare governance and structure–CMS, MACs, and private health plans under Parts A through D
• Beneficiary enrollment, coverage and benefits under Parts A through D
• Provider enrollment and certification under Parts A and B
• Private health plan application and selection under Parts C and D
• Conditions of participation and payment for Parts A and B
• Managed care regulation and payment under Parts C and D
• Transactions, demonstrations, and contracting
• Congressional legislation, agency guidance and key compliance resources

This session will review significant Medicare and Medicaid reimbursement changes in 2022, including:

• Trends in Graduate Medical Education
• CARES Act audits and enforcement
• New initiatives supporting rural health providers
• The evolution of behavioral health coverage
• Medicare Advantage changes
• A status update on the appeals process
• Developments in value-based payment models, including health equity initiatives
• HHS provisions in the 2023 Consolidated Appropriations Act and other reimbursement/enforcement developments

• How the Medicaid program is changing in each of the panelist’s states and nationally
• Innovative features of the particular State's Medicaid program potentially addressing such items as social determinants of health care (SDOH), health equity, managed care organizations, the opioid crisis, behavioral health, expansion, APMs, long term care and home and community-based care, and 1332 and 1115 waivers
• How COVID is affecting each of the panelists’ state programs, including most specifically the “Medicaid wind down,” and potentially what lessons have they learned and the actions the state is taking to prepare for future pandemics

• OIG Medicare and Medicaid oversight initiatives
• Industry guidance and expiration of the COVID-19 Public Health Emergency Declaration
• Review of significant OIG civil and administrative enforcement actions, compliance measures, and description of future trends

• How has CMS’s role as a regulator changed given the growth in the Medicare Advantage over the past five years? Does it alter the focus of the agency away from the annual payment rules (IPPS, OPPS, MPFS, etc.) and toward greater oversight of MA plans?
• How is CMS balancing the benefits of an smooth transition out of the PHE with beneficiary expectations for access to services (e.g., telehealth) that may no longer be covered or available?
• The Inflation Reduction Act includes the first major efforts by Congress to allow Medicare to negotiation drug prices. How does CMS anticipate that this will affect Medicare beneficiary drug costs, as well as access to drugs subject to negotiation? What other tools does CMS currently have to address the rising costs of drugs and other health care costs?
• How is CMS incorporating principles of Health Equity into the PHE “off-ramp,” for example, as it relates to access to services for underserved communities that were facilitated by PHE flexibilities (e.g., telehealth, hospital at home)?

President Biden presided over some of the most significant health policy changes in recent memory. As a new Congress begins, explore their health policy objectives, and learn what the President still desires to accomplish in the last two years of his first term.  This session will identify anticipated federal Medicare and Medicaid policy changes in 2023 and beyond, and assess how those changes could affect client strategies, budgets and transactions. Top priorities include:

• Hospital, physician and other provider payments
• Telehealth expansions and waivers
• Surprise billing regulations
• Affordable Care Act expansion
• Medicaid waivers
• Drug pricing

• A brief history of the Medicaid program and its program objectives
• The statutory requirements for Medicaid programs
• The ongoing and critical impact of the Medicaid program during the COVID-19 pandemic
• Different state approaches to Medicaid
• The future of the Medicaid program

The Medicare Cost Report continues to be the foundation upon which so much of a provider's reimbursement is built and remains a critical concern for most providers. As a result, it also serves as the basis for many of the regulatory and litigation issues health lawyers regularly face.  This session will provide a basic overview of the hospital cost report (Form 2552) intended for those not familiar with the form.  In this session, we will discuss the flow of the report, a fundamental understanding of cost-based reimbursement calculations, and important schedules containing key information.

• Cost report forms, filings, and deadlines
• Cost report schedules and flow
• Overhead step-down and cost-based reimbursement
• Cost Report Schedules Containing Key Information (Settlement, Wage Index, UC DSH, Financial Statements, etc.)

• 340B contract pharmacy litigation
• 340B patient eligibility and related litigation
• Fraud and abuse issues in 340B
• Medicare Part B payments to 340B hospitals

• Revised more flexible guidance from CMS
• Staffing and contracted services
• Space and emergency services
• Survey considerations
• Case studies of common co-location scenarios under the new guidance

• Medicare payment fundamentals for direct graduate medical education and indirect medical education
• Follow-up on CMS’s implementation of GME-related sections of Consolidated Appropriations Act
• CMS’s final rule following the Hershey fellows penalty decision and remaining open questions
• Remaining concerns with inadvertent establishment of a per-resident amount

• Primer on medical coding systems (ICD-10, CPT, and HCPCS)
• How medical coding impacts CMS payment to providers
• Summary of 2023 CPT code updates, including revisions to evaluation and management (E/M) codes and the new artificial intelligence taxonomy
• Impact of innovative medical technologies on coding systems and CMS payment policies

• Analysis and implications of the Talevski case in the U.S. Supreme Court on private enforcement of the Medicaid Act
• Significant litigation involving Medicaid waivers and supplemental payments
• Medicaid managed care litigation, including the authority to implement Medicaid managed care programs, the oversight of those programs, contracting, and provider relations
• Important cases regarding Medicaid benefits

• Medicare provider-based rules and case law
• Reasons for seeking provider-based status
• Typical challenges to achieving provider-based status
• Interplay with other Medicare requirements (e.g., co-location, under arrangements

• Medicare DSH and S-10 charity care
• Bad debt
• Medical education (GME/IME and NAHE)
• Outlier
• Miscellaneous other cost report worksheet changes

• In-depth explanation of the Medicare claims appeals process, how an appeal is initiated, and what to expect at each stage
• Strategic approaches to consider and implement when appealing overpayment demands and claim denials
• OMHA agency overview, return to 90-day processing, and ALJ practical tips from Chief Administrative Law Judge Allen
• Appellant and counsel tips for navigating a 90-day appeal processing timeframe

• Medicare enrollment basics
• Common pitfalls for Medicare Enrollment
• Enrollment considerations for transactions
• Navigating various state Medicaid requirements

• Recent developments in CMS’s program integrity efforts
• Recent priorities and developments in HHS-OIG enforcement efforts
• Recent priorities and developments in DOJ civil and criminal enforcement

• OIG’s Oversight of MA
• Recent OIG audits and evaluations
• Fraud Risk Areas

• Alert 23- what it means to you
• OH CDMS overview and updates
• Avoiding pitfalls and applying best practices before the Board

• Cell and gene therapies
• Orphan disease drugs
• Value-Based purchasing

This presentation will cover the challenges providers and litigants face when pursuing Medicare appeals, including appeals that involve statistical extrapolation by the Government. The presentation will cover:

• Methods in case preparation
• Challenges in the appeal process, including due process challenges and navigating the government's participation
• Digesting statistical strategy
• Reliability of medical review

• Final CY 2023 REH Conditions of Participation
• REH payment policy and example analyses
• Update of the process for transitioning to REH
• State legislative actions
• Current challenges, questions, concerns of the REH program

• Revised more flexible guidance from CMS
• Staffing and contracted services
• Space and emergency services
• Survey considerations
• Case studies of common co-location scenarios under the new guidance

• CMS has set a bold goal of having all Medicare fee-for-service beneficiaries in a care relationship with accountability for quality and total cost of care by 2030, while simultaneously advancing health equity
• Using examples from the Medicare Shared Savings Program, the ACO REACH Model, and state-based ACO initiatives, this session will focus on new policies designed to achieve these lofty aims by:
  • Increasing participation among safety-net and rural providers and entities new to ACO initiatives, while creating incentives for existing participants to continue their model participation
  • Reducing disincentives to provide robust care to historically underserved populations, and more strategically targeting high-risk populations to reduce health disparities
• Establishing innovative care delivery pathways while better aligning payment incentives with efficient, high-quality care
• The session will then discuss the legal, operational, and business case considerations of these new policies for ACO initiative participants, leveraging lessons learned from the Vermont Medicare ACO Initiative

When Congress established the Medicare Part D program as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”), Congress expanded and adopted the existing express preemption provision for the Medicare Advantage (“MA”) program into the new Part D benefit. Prior to the MMA, Medicare’s express preemption provision required a conflict preemption standard for most state laws, but provided that an enumerated list of fields of state regulation were preempted regardless of whether a state law was inconsistent with the federal requirement. The MMA eliminated the conflict requirement, and created a single all-encompassing clause that makes clear that state laws regulating MA and Part D plans are presumed preempted unless they fall into specified exceptions for state licensing laws and laws regulating plan solvency.

In the past few years, there has been an increase in states attempting to apply state regulations to MA and Part D plans. These regulations affect critical aspects of the Part D benefit, including areas that are subject to extensive federal regulation, including the amount a plan reimburses a pharmacy for a prescription drug, cost-sharing amounts, the inclusion of pharmacies in a plan’s network, and the distribution of plan materials to beneficiaries. Federal district courts and courts of appeal have been inconsistent in how they apply the Medicare express preemption standard, and the Supreme Court has yet to directly address the issue.

• Basic legal structure of the express preemption provision in MA and Part D, how the preemption standard evolved with the adoption of the MMA in 2003, and how courts have historically applied this statutory standard. Regulatory guidance from CMS on what the agency understands to be the scope of MA Part D preemption
• Current issues in MA and Part D Preemption: Recent efforts by states to regulate MA and Part D plans with a focus on state regulations of PBMs. How courts have evaluated recent legal challenges asserting that state PBM regulations are preempted by MA and Part D, and the resulting landscape from inconsistent court decisions
• New Trends and Looking Forward: Various trends in state laws that could implicate MA and Part D preemption, and whether we expect future clarity from courts on the scope of preemption

Address recent trends in Medicaid demonstration projects, including:

• Section 1115 flexibilities and requirements
• Litigation arising out of Trump Administration waivers
• New programmatic and financial flexibility
  • Health-Related Social Needs
  • Funding for Designated State Health Programs
  • Justice-Involved Populations
  • Continuous Eligibility
• New conditions
  • Payment adequacy
  • Budget neutrality “sub-caps”
  • Monitoring and evaluation

• Definition and taxonomy of supplemental payments
• Medicaid disproportionate share hospital (DSH)
• Medicaid non-DSH supplemental payments
• Medicaid managed care directed payments
• Medicaid waiver payments, including uncompensated care payments and quality and equity pools
• Medicaid financing (IGTs, CPEs, and provider taxes)

• Has a change of ownership (CHOW) occurred: CHOW situations and non-CHOW situations
• Benefits and burdens of accepting v. rejecting automatic assignment of the Medicare provider agreement
• Successor liability v. revenue gaps
• Change of ownership considerations for non-certified entities
• Medicare Enrollment and Notification Requirements related to CHOWs and changes of ownership
• Medicaid CHOW considerations

• Discuss attorney-client privilege issues that counsel in the health care and life sciences industries face on a regular basis when dealing both with investigations and litigation
• Practical tips about how assertions of privilege are dealt with both during investigations and in litigation
• Conflicts that arise as the result of the General Counsel’s working relationship with other members of the “C-suite”
• How to determine and define “clients”
• How to effectively maneuver through landmines in situations where there are communication issues between members of the C-suite and the board of directors
• How to handle privilege issues in the context of investigations and litigations
• When should the results of the investigation be subject to disclosure?

• Medicare payment fundamentals for direct graduate medical education and indirect medical education
• Follow-up on CMS’s implementation of GME-related sections of Consolidated Appropriations Act
• CMS’s final rule following the Hershey fellows penalty decision and remaining open questions
• Remaining concerns with inadvertent establishment of a per-resident amount

• Medicare provider-based rules and case law
• Reasons for seeking provider-based status
• Typical challenges to achieving provider-based status
• Interplay with other Medicare requirements (e.g., co-location, under arrangements

Building on foundations provided in the Medicaid Supplemental Payments and Financing primer session, we will discuss:

• Medicaid payment innovations, including directed payments and 1115 waiver-based payments
• Legislative changes to Medicaid DSH-eligible costs and upcoming allotment cuts
• Recent non-federal share financing issues, including CMS interpretation of provider tax rules
• Technical implications of federal spending limits
• The impact caused by the termination of certain COVID-19 measures

• Provide new insight into some of the “basic” concepts fundamental to the physician self-referral law using hypothetical scenarios
• Connect the dots between various pieces of governmental guidance, explore topics including remuneration, referrals, and “one-off” issues that can prove challenging to ensuring compliance with the physician self-referral law

Increased use of non-physician practitioners (NPPs) and clinical staff to provide medical care services has led to a myriad of rules related to supervising and billing for such services. An ongoing source of confusion has been identifying the circumstances and applicable requirements for physicians to bill for services performed with NPPs, clinical staff, or medical residents in various settings. This session will provide an in depth look at various complex regulations and considerations, including:

• Split/shared billing, including overview of recent regulatory changes
• Incident-to billing, including overview of recent regulatory changes for certain services
• Teaching physician billing for services performed with residents, the Primary Care Exception, and overlapping surgery requirements
• Determining physician compensation for supervisory services, including FMV and regulatory considerations

• The distribution of the $178 billion Provider Relief Fund
• The internal controls that were in-place prior to payments being distributed
• The current and future activities to ensure compliance with terms and conditions of the program
• Best practices for recipients within the reporting and auditing processes

• Explanation of OIG Authorities
• Hypothetical case studies
• Defense bar perspectives

• How Medicare and Medicaid reimburse Rural Health Clinics (RHCs)
• How Medicare and Medicaid reimburse Federally Qualified Health Centers (FQHCs)
• The most current reimbursement updates for both RHCs and FQHCs under Medicare & Medicaid
• How RHCs are adapting to the new reimbursement rules under the Medicare Modernization Act
• Specific states that are using an alternative payment methodology (APM) to reimburse FQHCs
• How clinics are employing strategies to increase both Medicare & Medicaid reimbursement

• Past year’s significant Medicare reimbursement decisions issued by the federal courts, including two Supreme Court decisions, as well as review of the relevant agency decisions at issue
• Litigation topics including: Jurisdiction; scope of the administrative record; substantive and procedural challenges (e.g., notice and opportunity to comment, contrary to law, and arbitrary and capricious); and remedies (e.g., remand orders and injunctions)
• Potential areas of future Medicare litigation implicated by the past year’s developments
• How courts and the agency have addressed the full spectrum of issues that might be applicable in Medicare litigation, thus giving attendees a better understanding of the strengths and weaknesses of ongoing reimbursement issues

• Modernizing the administration and operation of Medicaid managed care
  • Overall state trends to shift populations into managed care
  • 2016, 2017, and 2020 rulemakings; potential 2023 rulemaking
• Fiscal accountability in Medicaid managed care (capitation/risk adjustment, medical loss ratio, value based payments, directed payments)
• Provider relations (network v. non-network providers, out-of-network reimbursement, network adequacy, contracting issues)
• Social health and continuity of care (case management, care coordination, social determinants of health, in lieu of services, and other updates)

• Medicare DSH and S-10 charity care
• Bad debt
• Medical education (GME/IME and NAHE)
• Outlier
• Miscellaneous other cost report worksheet changes

• Roles of CMS, FDA, CDC and state agencies in regulating clinical lab industry
• The VALID Act and its implications for laboratory developed testing
• Ongoing PAMA obligations, including changes made in 2023 Consolidated Appropriations Act
• 2022 CMS Final Rule on laboratory proficiency testing, including application of anti-referral standards to waived tests
• Clinical lab enforcement activities in 2022-2023, including EKRA , FCA and AKS

• The recent CMS proposed rule abandoning the “reasonable diligence” standard and changing the definition of when a provider is deemed to have “identified” an overpayment under the Overpayment Statute
• The criteria for identifying Medicare “conditions of payment” capable of triggering overpayments, as distinct from “conditions of participation” and other program rules
• How Supreme Court decisions, Kisor v. Wilkie and Allina Health Services, and pending cases, SuperValu and Safeway, inform providers’ thinking about potential overpayments
• How federal courts have applied the Escobar “materiality” standard over the past year in the Medicare overpayments and FCA contexts
• Specific overpayment scenarios and case studies

• The two Medicare coverage rules called “incident to.” The criteria in non-facility (e.g., physician office/clinic settings) versus criteria for facility settings such as hospitals
• Implications for non-physician practitioners working in these respective settings and how answers to questions change based on the employing entity
• An explanation of billing and payment implications including split/shared E/M services
• Anti-kickback and Stark implications by applying the rules to various scenarios

• 340B Contract Pharmacy Litigation
• 340B Patient Eligibility and Related Litigation
• Fraud and Abuse Issues in 340B
• Medicare Part B Payments to 340B Hospitals

• The distribution of the $178 billion Provider Relief Fund
• The internal controls that were in-place prior to payments being distributed
• The current and future activities to ensure compliance with terms and conditions of the program
• Best practices for recipients within the reporting and auditing processes

• Introduction of Board members
• Board decisions
• Jurisdiction
• Hearings
• Case inventory
• Board initiatives
• Board Rules and mandatory electronic filing
• Evaluation of decision process
• Observations from the Board

• Challenges providers and litigants face when pursuing Medicare appeals, including appeals that involve statistical extrapolation by the Government.
• Methods in case preparation
• Challenges in the Appeal Process, including due process challenges and navigating the Government's participation
• Digesting Statistical Strategy
• Reliability of Medical Review

• Final CY 2023 REH Conditions of Participation
• REH Payment Policy and example analyses
• Update of the process for transitioning to REH
• State Legislative Actions
• Current challenges, questions, concerns of the REH program

• Recent developments in CMS’s program integrity efforts
• Recent priorities and developments in HHS-OIG enforcement efforts
• Recent priorities and developments in DOJ civil and criminal enforcement

• OIG’s Oversight of MA
• Recent OIG audits and evaluations
• Fraud Risk Areas

When Congress established the Medicare Part D program as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”), Congress expanded and adopted the existing express preemption provision for the Medicare Advantage (“MA”) program into the new Part D benefit. Prior to the MMA, Medicare’s express preemption provision required a conflict preemption standard for most state laws, but provided that an enumerated list of fields of state regulation were preempted regardless of whether a state law was inconsistent with the federal requirement. The MMA eliminated the conflict requirement, and created a single all-encompassing clause that makes clear that state laws regulating MA and Part D plans are presumed preempted unless they fall into specified exceptions for state licensing laws and laws regulating plan solvency.

In the past few years, there has been an increase in states attempting to apply state regulations to MA and Part D plans. These regulations affect critical aspects of the Part D benefit, including areas that are subject to extensive federal regulation, including the amount a plan reimburses a pharmacy for a prescription drug, cost-sharing amounts, the inclusion of pharmacies in a plan’s network, and the distribution of plan materials to beneficiaries. Federal district courts and courts of appeal have been inconsistent in how they apply the Medicare express preemption standard, and the Supreme Court has yet to directly address the issue.

• Basic legal structure of the express preemption provision in MA and Part D, how the preemption standard evolved with the adoption of the MMA in 2003, and how courts have historically applied this statutory standard. Regulatory guidance from CMS on what the agency understands to be the scope of MA Part D preemption
• Current issues in MA and Part D Preemption: Recent efforts by states to regulate MA and Part D plans with a focus on state regulations of PBMs. How courts have evaluated recent legal challenges asserting that state PBM regulations are preempted by MA and Part D, and the resulting landscape from inconsistent court decisions
• New Trends and Looking Forward: Various trends in state laws that could implicate MA and Part D preemption, and whether we expect future clarity from courts on the scope of preemption

Address recent trends in Medicaid demonstration projects, including:

• Section 1115 flexibilities and requirements
• Litigation arising out of Trump Administration waivers
• New programmatic and financial flexibility
  • Health-Related Social Needs
  • Funding for Designated State Health Programs
  • Justice-Involved Populations
  • Continuous Eligibility
• New conditions
  • Payment adequacy
  • Budget neutrality “sub-caps”
  • Monitoring and evaluation

• Discuss attorney-client privilege issues that counsel in the health care and life sciences industries face on a regular basis when dealing both with investigations and litigation
• Practical tips about how assertions of privilege are dealt with both during investigations and in litigation
• Conflicts that arise as the result of the General Counsel’s working relationship with other members of the “C-suite”
• How to determine and define “clients”
• How to effectively maneuver through landmines in situations where there are communication issues between members of the C-suite and the board of directors
• How to handle privilege issues in the context of investigations and litigations
• When should the results of the investigation be subject to disclosure?

Increased use of non-physician practitioners (NPPs) and clinical staff to provide medical care services has led to a myriad of rules related to supervising and billing for such services. An ongoing source of confusion has been identifying the circumstances and applicable requirements for physicians to bill for services performed with NPPs, clinical staff, or medical residents in various settings. This session will provide an in depth look at various complex regulations and considerations, including:

• Split/shared billing, including overview of recent regulatory changes
• Incident-to billing, including overview of recent regulatory changes for certain services
• Teaching physician billing for services performed with residents, the Primary Care Exception, and overlapping surgery requirements
• Determining physician compensation for supervisory services, including FMV and regulatory considerations

• Modernizing the administration and operation of Medicaid managed care
  • Overall state trends to shift populations into managed care
  • 2016, 2017, and 2020 rulemakings; potential 2023 rulemaking
• Fiscal accountability in Medicaid managed care (capitation/risk adjustment, medical loss ratio, value based payments, directed payments)
• Provider relations (network v. non-network providers, out-of-network reimbursement, network adequacy, contracting issues)
• Social health and continuity of care (case management, care coordination, social determinants of health, in lieu of services, and other updates)

• The two Medicare coverage rules called “incident to.” The criteria in non-facility (e.g., physician office/clinic settings) versus criteria for facility settings such as hospitals
• Implications for non-physician practitioners working in these respective settings and how answers to questions change based on the employing entity
• An explanation of billing and payment implications including split/shared E/M services
• Anti-kickback and Stark implications by applying the rules to various scenarios