Schedule

• A brief history of the Medicaid program and its program objectives

• The statutory requirements for Medicaid programs

• Different state approaches to Medicaid

• The role of managed care in the Medicaid program

• The future of the Medicaid program

• Reimbursement systems applicable to Part A and B providers

• Conditions of participation and payment required to participate in Part A and B

• Governance and structure: CMS, ROs (and the transition to PEOGs), and MACs

• Provider enrollment and certification

• How Part A and B interplay with transactions

• Congressional legislation, agency guidance and key compliance resources

This session will provide an update on key Medicare and Medicaid reimbursement and policy changes that occurred during 2023, including the following:

• New or expanded policy initiatives, such as efforts to advance health equity across various reimbursement programs, expand access to behavioral health care, implementation of Medicare’s Drug Price Negotiation Program, continued expansion of telehealth coverage, CMS’ proposal to pay providers to train informal caregivers and increased funding and expansion of coverage for substance use disorder treatment

• New reimbursement programs, including New Dementia Care Model, New Oncology Care Model, Making Care Primary Model, changes to the ACO REACH Model, efforts to expand participation in the Medicare Shared Savings Program and extension of the Medicare Advantage Value-Based Insurance Design program

• Key hospital, physician and other federal provider / supplier payment rules from the 2024 rulemaking cycle, as well as the mental health parity proposed rule, implementation of the Medicaid Services Investment and Accountability Act of 2019, changes to Medicare Advantage and efforts to remedy underpayments in the 340b drug discount program

• Developments in enforcement, including efforts to crack down on improper reimbursement for genetic tests, oversight of Covid-19 Public Health Emergency relief funds and improper payment for opioid use disorder treatment

• Continued efforts to increase transparency in health care, including update on implementation and enforcement of the No Surprises Act, proposed rule to expand and standardize hospitals’ price transparency obligations and current legislative initiatives such as the Modernizing and Ensuring PBM Accountability Act, the Providers/Payers COMPETE Act and the Health Care Price Transparency Act

• OIG Medicare and Medicaid oversight initiatives

• OIG’s recently released General Compliance Program Guidance (GCPG)

• Review of significant OIG civil and administrative enforcement actions, compliance measures, and description of future trends

Health policy will figure prominently in the presidential and congressional election. President Biden and Congress will seek to define and differentiate their positions by advancing health policy changes, and they may even align on some impactful on a few matters. This session will identify anticipated federal Medicare and Medicaid policy changes in 2024 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

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.)

• 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

• Recent litigation involving rulemaking and the authority of informal guidance

• Comparative Overview Critical Differences Based on Site/Organization Type

  • Medicare GME Payment Mechanics

  • Teaching Physician Billing Rules vs GME Payment Rules

  • Hospitals vs Non-Hospital Sites

  • GME Payment to Urban vs Rural Hospitals and Entities

• Focus on New Opportunities and Recent Changes

  • Background – policy aim/workforce impact

  • Background on the Rural Training Track (RTT) program before the CAA, 2021

  • Updates on the new RTP program/affiliation agreements

  • Other opportunities arising out of legislation or litigation

• Key Considerations in Planning for and Operating GME Programs

  • Community support

  • Wage index issues

  • Interplay with HRSA planning grants: RRPD and RRPD-TA

With over 72% of the Medicaid population enrolled in comprehensive Medicaid managed care organizations (MCOs), network participation agreements and corresponding business relationships with MCOs are a significant component of managed care operations. This session will discuss issues specific to Medicaid managed care from the payer and provider perspective, including:

• Reimbursement        

• Key Contracting considerations

• Alternative Payment Models and Value Based Arrangements

• Unique Provider Sponsored Health Plans

• Navigating the regulatory complexity

• Updated Compliance Tools and Resources from CMS

• Updates on co-location for hospitals

• Facility survey considerations

• Case studies of common co-location scenarios under the new guidance

• Has a change of ownership 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

• Alphabet Soup—Medicare Advantage Organization and Part D Sponsor Plan Types: HMO, PPO, EGWP, SNP, DSNP, ISNP, CSNP, MMP

• CMS contracting—Licensure, service area, network adequacy, application, bid, renewal, consolidation, termination

• Delivering benefits—required basic benefits, permitted supplemental benefits, value-based insurance design

• Getting paid—capitation, premium, quality bonus payment, low-income subsidy, risk adjustment, risk corridors, reinsurance, data reporting

• Provider-based terminology

• Advantages and disadvantages of provider-based status

• Qualifying for provider-based status

• Rules on enrollment, billing, and reimbursement

• Related issues: Under arrangements / implications for cccess to 340B drugs / co-location

• The complex structure of a teaching hospital with employed and non-employed researchers

• The responsibilities of the different parties

• The potential liabilities of the different parties

• How much control is right for your organization?

• The new cost report listings required by Transmittal 18 and the common pitfalls obtaining the necessary patient information

• The new additional S-10 Worksheet (Part I and Part II) and future Uncompensated Care payment implications

• The S-10 audit process and review common findings during the latest round of nationwide audits

• CMS’s retroactive ‘final action” on part C days in the DSH calculation for pre-10/1/2013 periods and challenges to it

• Latest developments on resolution of pending Section 1115 waiver day appeals and new prospective rule restricting waiver days in the DSH calculation

• D.C. Circuit decisions in Advocate Christ and Pomona on days counted as “entitled” in the SSI fraction

• Medicare Enrollment Basics

• Updates to Medicare Provider Enrollment Regulations

• Common Pitfalls for Medicare Provider 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 and False Claims Act case law

• Inpatient and outpatient hospital payment update

• New technology add-on payment changes

• Wage index issues

• Disproportionate share and uncompensated care

• 340B litigation update

• Remote Outpatient Therapy, Diabetes Self-Management Training and Medical Nutrition Therapy

• Intensive outpatient services

• Hospital transparency data

• Telehealth/digital

  • Distinction between digital vs virtual (asynchronous–collecting info v synchronous–real-time)

  • Stakeholders analysis / why important

• Post-Public Health Emergency (PHE) landscape for tele/digital health

  • Extension of copay and deductible waivers

  • Will these waivers become permanent?

  • CMS reimbursement post-PHE

  • Stakeholders analysis / why important

• Rural Access to Care (thru Tele/digital health methods)

  • Coding

  • How would CMS pay

  • Stakeholders analysis / why important

• RTM, RPM, and what’s next?

  • RTM (behavior; therapeutics; preventive/wellness; general medicine codes; likely physical therapists/clinical psych/speech-language pathologists/occupational therapists, etc);

  • RPM (monitoring; evaluation/management codes by physicians/qualified health care providers)

  • Wellness model vs treatment model

  • Stakeholders analysis / why important

• Liability Risk

  • Prescription medications, GLP-1s, C2

  • State/jurisdictional variance of telehealth requirements

• 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

• Golden Oldies

• Current Hits and Events

• Enduring Enforcement Trends

• Some “Grace Notes”

• What are health related social needs (HRSN)?

• How is CMS encouraging State Medicaid programs to address HRSN?

• What are the different options Medicaid agencies can pursue?

• What are the parameters for receiving federal funding?

• Recent Intensification of Regulatory Requirements and Operational Challenges for Medicare Plans

  • Changes to coverage criteria and prior authorization requirements

  • Translation requirements

  • Behavioral health network adequacy

  • Forecast of challenges ahead for 2025

• Medicare Part C and Part D oversight and enforcement trends

  • Prior authorization audits

  • Program audits

  • Risk adjustment landscape

  • Plans in the policy and enforcement crosshairs: Congress, DOJ, OIG, CMS, and Federal Courts

• Contract pharmacy

• Patient definition

• Billing Medicare and Medicaid for 340B drugs

• Legislation outlook- state and federal

Medicaid is a program jointly financed by the federal government and the states. The financing rules that specify how the federal government will and will not match the non-federal share is a case study in federalism and has shaped the Medicaid program’s structure. This session focuses on Medicaid financing issues, including but not limited to the bulleted items below.

• Federal Financial Participation and the Federal Medical Assistance Percentage

• Permissible sources of the non-federal share

• Disputes and ambiguities regarding intergovernmental transfers and provider taxes

• Provider Tax waivers and hold harmless issues

The Medicare program is governed by voluminous statutes, regulations, and sub-regulatory guidance that potentially carry payment implications for various items and services. The federal Overpayments Statute (SSA § 1128J(d)) and its implementing regulations and CMS guidance impose certain obligations on providers and suppliers to affirmatively report and refund identified overpayments. Several significant federal court cases have drawn some important boundaries around what kinds of program rules and requirements potentially can result in Medicare overpayments. This presentation will explore risks and obligations under the federal Overpayments Statute and, derivatively, the FCA. The presentation will assume familiarity with the federal Overpayments Statute, regulations, and guidance. We will discuss recent case law and key concepts and considerations through overpayment scenarios and case studies.

• The 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

• Criteria for identifying Medicare “conditions of payment” capable of triggering overpayments, as distinct from “conditions of participation” and other program rules

• Supreme Court decisions, Kisor, Allina, SuperValu and Safeway, etc., that inform providers’ thinking about potential overpayments

• Federal court cases applying the Escobar “materiality” standard

• Practical strategies and real-life examples for resolving potential overpayment situations

• Historical context of Chevron

• Implications of Chevron decision on courts’ review of CMS’s regulations

• Case law trajectory leading the Court to accept review of the Loper case

• Possible outcomes of Loper and implications for healthcare providers

• The courts’ analytical framework where only “subregulatory guidance” is at issue

Leveraging the perspective and experience of both a private practice litigator and a DOJ litigator, this session will cover:

• The past year’s significant Federal court decisions affecting Medicare reimbursement, as well as the underlying agency actions

• Issues particularly pertinent to Medicare litigation such as jurisdiction, scope of the administrative record, substantive and procedural challenges, and remedies

• What recent decisions tell us about the strengths and weaknesses of ongoing Medicare reimbursement appeals

• Potential areas of future Medicare litigation implicated by the past year’s developments

• 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 and False Claims Act case law

• Lifecycle of Medicare claim appeals from initial determination through judicial review

• Update from the Medicare Appeals Council

• Practice tips on Medicare claim appeals

• Case Example – Complex Overpayment

• Special Issues

• Modernizing the administration and operation of Medicaid managed care

  • Overall state trends to shift populations into managed care

  • 2016, 2017, and 2020 rulemakings; proposed (and potentially final) 2023-24 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 overhaul of Evaluation and Management (E/M) visits has been completed and split/shared visits, telemedicine, and remote services guidelines are in transition. How do we ensure we have interpreted and implemented the new guidelines appropriately? We will provide an overview of the recent E/M changes and highlights from the 2024 MPFS Final Rule.

• Gain an understanding of the history of E/M and Split/Shared visit rules

• The compliance risks associated with recent CPT and MPFS E/M changes.

• Anticipate the impact of the changes on physician compensation and patient flow

• Contemplate how the 2024 MPFS Final Rule gives insight on what to expect going forward from CMS

A slew of recent guidance from the DOJ related to the value of cooperation in DOJ criminal investigations has changed the compliance landscape and raised the stakes of operating an effective compliance program. More importantly, it has changed the landscape for internal compliance activities and how such activities should be conducted and documented. This panel will deal with the ethical responsibility and attorney client privilege risks and opportunities for in-house and outside counsel, and attorneys working as compliance officers in conducting internal investigations and in reviewing and improving compliance programs:

• 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 and when to assert privilege over compliance program activities

• Strategies for avoiding Conflicts of Interest, and ensuring the client’s interests are paramount

• How to determine and define “clients”

• How to effectively maneuver through landmines in communications in and around the compliance program, including communications regarding deficiencies and remediation, investigation findings and response, and involvement of non-legal outside entities

• What considerations should companies evaluate when deciding whether compliance activity should be conducted under privilege, or be left subject to potential disclosure?

• The complex structure of a teaching hospital with employed and non-employed researchers

• The responsibilities of the different parties

• The potential liabilities of the different parties

• How much control is right for your organization?

This session will look at the administrative enforcement tools available to OIG and CMS - how they differ and how they can each be used in response to compliance failures. We will include a case study involving a physician who is facing consequences in addition to, or parallel with, a DOJ investigation.

• OIG exclusion and CMP authorities

• CMS billing privileges revocations and reenrollment bars

• The CMS Preclusion List

• Non-HHS consequences linked to OIG/CMS actions, e.g., commercial plan credentialing and NPDB

• Potential Medicare Overpayment Liabilities

• Using hypothetical scenarios, this advanced-level presentation will provide new insight into some of the “basic” concepts fundamental to the physician self-referral law

• Connecting the dots between various pieces of governmental guidance, the speakers will explore topics including remuneration, referrals, and “one-off” issues that can prove challenging to ensuring compliance with the physician self-referral law

• The speakers welcome your questions in advance of the panel, and will do their best to incorporate them into the presentation

• The history and current developments involving the growing trend to shift patient care for acute illnesses into the home

• Efforts at the federal and state level to enable patients to undergo increasingly acute treatment in their home environment, including CMS waiver programs, state accommodations, and areas of opportunity for growth

• Challenges unique to this care model, including:

  • Reimbursement for services delivered in the home

  • Facility and professional licensure considerations

  • Enrollment, credentialing, and participation

  • Coordination of the comprehensive delivery of health care at home across providers

• A look to the future of home-based acute health care services, and what it might mean for patients, new market entrants, and institutional providers over the coming years

• Updated Compliance Tools and Resources from CMS

• Updates on co-location for hospitals

• Facility survey considerations

• Case studies of common co-location scenarios under the new guidance

• The new cost report listings required by Transmittal 18 and the common pitfalls obtaining the necessary patient information

• The new additional S-10 Worksheet (Part I and Part II) and future Uncompensated Care payment implications

• The S-10 audit process and review common findings during the latest round of nationwide audits

• CMS’s retroactive ‘final action” on part C days in the DSH calculation for pre-10/1/2013 periods and challenges to it

• Latest developments on resolution of pending Section 1115 waiver day appeals and new prospective rule restricting waiver days in the DSH calculation

• D.C. Circuit decisions in Advocate Christ and Pomona on days counted as “entitled” in the SSI fraction

This session will highlight key efforts to advance the priorities of the CMS Frameworks for Health Equity and Advancing Health Care in Rural, Tribal, and Geographically Isolated Communities including:

• Disparities in Medicare Advantage associated with dual eligibility or eligibility for a low-income subsidy and disability; disparities in health care in Medicare Advantage by race, ethnicity, and sex, and rural-urban disparities in Medicare

• FY23 activities including rural emergency hospital designation, postpartum coverage expansion, and innovative models

• Medicare hospital quality reporting programs

• Medicare coverage and payment for services to address health and social needs

• State Section 1115 and Section 1915 demonstration projects to advance health equity

• How Medicare and Medicaid reimburse Rural Health Clinics (RHCs)

• How the Medicare final rules affect both RHCs and FQHCs

• How Medicare and Medicaid reimburse Federally Qualified Health Centers (FQHCs)

• 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

• Comparative Overview Critical Differences Based on Site/Organization Type

  • Medicare GME Payment Mechanics

  • Teaching Physician Billing Rules vs GME Payment Rules

  • Hospitals vs Non-Hospital Sites

  • GME Payment to Urban vs Rural Hospitals and Entities

• Focus on New Opportunities and Recent Changes

  • Background – policy aim/workforce impact

  • Background on the Rural Training Track (RTT) program before the CAA, 2021

  • Updates on the new RTP program/affiliation agreements

  • Other opportunities arising out of legislation or litigation

• Key Considerations in Planning for and Operating GME Programs

  • Community support

  • Wage index issues

  • Interplay with HRSA planning grants: RRPD and RRPD-TA

With over 72% of the Medicaid population enrolled in comprehensive Medicaid managed care organizations (MCOs), network participation agreements and corresponding business relationships with MCOs are a significant component of managed care operations. This session will discuss issues specific to Medicaid managed care from the payer and provider perspective, including:

• Reimbursement        

• Key Contracting considerations

• Alternative Payment Models and Value Based Arrangements

• Unique Provider Sponsored Health Plans

• Navigating the regulatory complexity

• Provider-based terminology

• Advantages and disadvantages of provider-based status

• Qualifying for provider-based status

• Rules on enrollment, billing, and reimbursement

• Related issues: Under arrangements / implications for cccess to 340B drugs / co-location

The panel will be comprised of the Medicaid Directors from Maryland, Kentucky and Indiana and moderated by Michael Cook, former Chair of the Board that oversees Virginia’s Medicaid program. This session will discuss:

• How the Medicaid program is changing in each State and nationally

• Innovative features of each State's Medicaid program and respond to attendee questions potentially addressing such issues as social determinants of health care (SODH), health equity, managed care organizations, the opioid crisis, the Medicaid winddown, behavioral health, expansion, APMs, long term care and home and community-based care, and 1332 and 1115 waivers

• If and how COVID is still affecting their various programs, e.g. staffing shortages, and potentially what lessons have they learned and the actions the state is taking to prepare for future pandemics

• The Stark Law VBE rules

• The Antikickback VBE rules

• Why do we need to understand VBE - the transition from volume-to-value and how to use the VBE rules (with a few examples)

• How creating a VBE can be a good strategy and can significantly reduce risk

• History and trends in Medicare Advantage (MA) enrollment compared to the decline in traditional (fee-for-service (FFS)) Medicare

• Potential hospital payment differences for care provided to FFS and MA enrollees, and how MA data in the hospital cost report influences key reimbursement drivers

• Contracting language to address payment disposition and final reimbursement reconciliations

• Current and projected trends in litigation involving MA impacts to hospital cost report payment issues

• Inpatient and outpatient hospital payment update

• New technology add-on payment changes

• Wage index issues

• Disproportionate share and uncompensated care

• 340B litigation update

• Remote Outpatient Therapy, Diabetes Self-Management Training and Medical Nutrition Therapy

• Intensive outpatient services

• Hospital transparency data

Leveraging the perspective and experience of both a private practice litigator and a DOJ litigator, this session will cover:

• The past year’s significant Federal court decisions affecting Medicare reimbursement, as well as the underlying agency actions

• Issues particularly pertinent to Medicare litigation such as jurisdiction, scope of the administrative record, substantive and procedural challenges, and remedies

• What recent decisions tell us about the strengths and weaknesses of ongoing Medicare reimbursement appeals

• Potential areas of future Medicare litigation implicated by the past year’s developments

• On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA)—the law’s “Prescription Drug Pricing Reform” provisions represent the most significant changes to Medicare payment for drugs and biologicals in decades

  • Among other provisions, the law authorizes the Medicare program to negotiate prices for certain Medicare-covered drugs, and requires manufacturers that raise their drug prices faster than the rate of inflation to pay a rebate to Medicare and reduces Part B coinsurance for these drugs for people with Medicare

  • The law also contains several other provisions intended to reduce out-of-pocket expenditures for Medicare beneficiaries for drugs and certain vaccines.

• CMS’ ongoing implementation of the IRA’s Prescription Drug Pricing Reform provisions a year and a half post-enactment

• The key statutory provisions, timelines, and the steps CMS has taken to implement them to date, with a primary focus on the drug price negotiation provisions

• Legal considerations for pharmaceutical companies and providers as a result of the changes under the IRA, and how those changes will affect patients in the coming years

• OH CDMS overview and up-dates

• Jurisdictional, procedural, and case management concerns

• Avoiding pitfalls and applying best practices before the Board

• Emerging trends

• Golden Oldies

• Current Hits and Events

• Enduring Enforcement Trends

• Some “Grace Notes”

• What are health related social needs (HRSN)?

• How is CMS encouraging State Medicaid programs to address HRSN?

• What are the different options Medicaid agencies can pursue?

• What are the parameters for receiving federal funding?

The Medicare program is governed by voluminous statutes, regulations, and sub-regulatory guidance that potentially carry payment implications for various items and services. The federal Overpayments Statute (SSA § 1128J(d)) and its implementing regulations and CMS guidance impose certain obligations on providers and suppliers to affirmatively report and refund identified overpayments. Several significant federal court cases have drawn some important boundaries around what kinds of program rules and requirements potentially can result in Medicare overpayments. This presentation will explore risks and obligations under the federal Overpayments Statute and, derivatively, the FCA. The presentation will assume familiarity with the federal Overpayments Statute, regulations, and guidance. We will discuss recent case law and key concepts and considerations through overpayment scenarios and case studies.

• The 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

• Criteria for identifying Medicare “conditions of payment” capable of triggering overpayments, as distinct from “conditions of participation” and other program rules

• Supreme Court decisions, Kisor, Allina, SuperValu and Safeway, etc., that inform providers’ thinking about potential overpayments

• Federal court cases applying the Escobar “materiality” standard

• Practical strategies and real-life examples for resolving potential overpayment situations

• Historical context of Chevron

• Implications of Chevron decision on courts’ review of CMS’s regulations

• Case law trajectory leading the Court to accept review of the Loper case

• Possible outcomes of Loper and implications for healthcare providers

• The courts’ analytical framework where only “subregulatory guidance” is at issue

• The Stark Law VBE rules

• The Antikickback VBE rules

• Why do we need to understand VBE - the transition from volume-to-value and how to use the VBE rules (with a few examples)

• How creating a VBE can be a good strategy and can significantly reduce risk

• History and trends in Medicare Advantage (MA) enrollment compared to the decline in traditional (fee-for-service (FFS)) Medicare

• Potential hospital payment differences for care provided to FFS and MA enrollees, and how MA data in the hospital cost report influences key reimbursement drivers

• Contracting language to address payment disposition and final reimbursement reconciliations

• Current and projected trends in litigation involving MA impacts to hospital cost report payment issues

• Telehealth/digital

  • Distinction between digital vs virtual (asynchronous–collecting info v synchronous–real-time)

  • Stakeholders analysis / why important

• Post-Public Health Emergency (PHE) landscape for tele/digital health

  • Extension of copay and deductible waivers

  • Will these waivers become permanent?

  • CMS reimbursement post-PHE

  • Stakeholders analysis / why important

• Rural Access to Care (thru Tele/digital health methods)

  • Coding

  • How would CMS pay

  • Stakeholders analysis / why important

• RTM, RPM, and what’s next?

  • RTM (behavior; therapeutics; preventive/wellness; general medicine codes; likely physical therapists/clinical psych/speech-language pathologists/occupational therapists, etc);

  • RPM (monitoring; evaluation/management codes by physicians/qualified health care providers)

  • Wellness model vs treatment model

  • Stakeholders analysis / why important

• Liability Risk

  • Prescription medications, GLP-1s, C2

  • State/jurisdictional variance of telehealth requirements

• Contract pharmacy

• Patient definition

• Billing Medicare and Medicaid for 340B drugs

• Legislation outlook- state and federal

A slew of recent guidance from the DOJ related to the value of cooperation in DOJ criminal investigations has changed the compliance landscape and raised the stakes of operating an effective compliance program. More importantly, it has changed the landscape for internal compliance activities and how such activities should be conducted and documented. This panel will deal with the ethical responsibility and attorney client privilege risks and opportunities for in-house and outside counsel, and attorneys working as compliance officers in conducting internal investigations and in reviewing and improving compliance programs:

• 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 and when to assert privilege over compliance program activities

• Strategies for avoiding Conflicts of Interest, and ensuring the client’s interests are paramount

• How to determine and define “clients”

• How to effectively maneuver through landmines in communications in and around the compliance program, including communications regarding deficiencies and remediation, investigation findings and response, and involvement of non-legal outside entities

• What considerations should companies evaluate when deciding whether compliance activity should be conducted under privilege, or be left subject to potential disclosure?

• The history and current developments involving the growing trend to shift patient care for acute illnesses into the home

• Efforts at the federal and state level to enable patients to undergo increasingly acute treatment in their home environment, including CMS waiver programs, state accommodations, and areas of opportunity for growth

• Challenges unique to this care model, including:

  • Reimbursement for services delivered in the home

  • Facility and professional licensure considerations

  • Enrollment, credentialing, and participation

  • Coordination of the comprehensive delivery of health care at home across providers

• A look to the future of home-based acute health care services, and what it might mean for patients, new market entrants, and institutional providers over the coming years