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© 2020 PYA, P.C.
WE ARE AN INDEPENDENT MEMBER OF HLB—THE GLOBAL ADVISORY AND ACCOUNTING NETWORK
Remote Compliance:
Maintaining Effectiveness During Crisis
HCCA Richmond Regional Healthcare
Compliance Conference
December 11, 2020
Presented by:
Lori Foley, CMA, CHC®, PHR, SHRM-CP
Kristen Davidson, MHA, CCEP-I®, CHC®, CPHQ, RHIA®
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Agenda
1. Identifying and Prioritizing Risk During a Crisis
2. Managing Compliance Programs and People Remotely
3. More with Less – The Effects of Furloughs and Layoffs
on Compliance
4. Questions and Group Discussion
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Identifying and Prioritizing Risk During a Crisis
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The Compliance Officer
In the Age of COVID-19
• Changed and/or relaxed regulatory and legal requirements are
creating confusion
• Active participant in decision making regarding the use of various
pandemic disaster relief tools
• Must establish a process to report, track, document, and follow-up
on all procedural changes
• Serve as the guardian of the crucial repository of information
necessary to validate waivers, exceptions, etc.
• Often the primary source of regulatory information for the
organization
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• Compliance is now fully engaged in managing the day-to-day
COVID-19 firefighting.
• Compliance teams need to quickly pivot and consider the risks and
challenges created by these rapid and radical changes.
• It is imperative for Compliance to perform a risk assessment in order
to quickly understand the new circumstances and address the risks.
• Compliance must manage the changing risks through expedited actions:
• Seeking relief from regulators
• Updating policies and internal controls
• Properly escalating issues
• Compliance professionals must pull together teams and relevant
information for informed conversations about new and emerging risks.
The New Normal
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Fraud, Waste, and Abuse
Relief Funding Top Fraud Schemes
Free COVID-19 Testing
Whistleblowers
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https://oig.hhs.gov/about-oig/strategic-plan/COVID-OIG-Strategic-Plan.pdf
OIG Strategic Plan
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OIG Strategic Plan Goals
✓ Assist in and support ongoing COVID-19 response efforts, while maintaining independence
✓ Fight fraud and scams that endanger HHS beneficiaries and the public Round II –$20 billion
✓ Assess the impacts of HHS programs on the health and safety of beneficiaries and the public
Goal 1: Protect People
✓ Prevent, detect, and remedy waste or misspending of COVID-19 response and recovery funds
✓ Fight fraud and abuse that diverts COVID-19 funding from intended purposes or exploits emergency flexibilities granted to health and human services providers
Goal 2: Protect Funds
✓ Protect the security and integrity of IT systems and health technology
Goal 3: Protect Infrastructure
✓ Support the effectiveness of federal, state, and local COVID-19 response and recovery efforts
✓ Leverage successful practices and lessons learned to strengthen HHS programs for the future
Goal 4: Promote Effectiveness
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FOOD & DRUG ADMIN
SUSTANCE ABUSE/MENTAL HEALTH SERVICES ADMIN
HEALTH & HUMAN SERVICES (HHS)
HEALTH RESOURCES & SERVICES ADMIN
OFFICE OF THE SECRETARY (OS)
CENTERS FOR DISEASE CONTROL (CDC)
ASST SEC PREPAREDNESS & RESPONSE
ACF/CDC/HHS
OS, CDC, HEALTH RESOURCES & SERVICES ADMIN
INDIAN HEALTH SERVICES
ADMIN FOR CHILDREN & FAMILIES (ACF)
CENTERS FOR MEDICARE & MEDICAID
OIG COVID-Related Workplans
as of 11/30/20
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• Infection Control at Home Health Agencies During the COVID-19
Pandemic
• Audit of Medicare Payments for Inpatient Discharges Billed by
Hospitals for Beneficiaries Diagnosed With COVID-19
• Audit of CARES Act Provider Relief Funds—General and Targeted
Distributions to Hospitals
• Infection Control and Emergency Preparedness at Dialysis Centers
During the COVID-19 Pandemic
• A Review of Medicare Data To Understand Hospital Utilization During
COVID-19
CMS Focused Workplans
Note: Represents reviews conducted by Office of Audit Services;
additional reviews are conducted by Office of Evaluation and Inspections
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• End Stage Renal Disease Networks' Responsibilities During COVID-19
• Medicaid: Expedited Provider Enrollment During COVID-19 Emergency
• Centers for Medicare & Medicaid Services and States Implement Policy
Modifications To Ensure That Medicaid Beneficiaries Continue To
Receive Prescriptions
• Medicaid—Telehealth Expansion During COVID-19 Emergency
• Audit of Nursing Homes' Reporting of COVID-19 Information Under
CMS's New Requirements
CMS Focused Workplans
Note: Represents reviews conducted by Office of Audit Services;
additional reviews are conducted by Office of Evaluation and Inspections
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• Audit of Nursing Home Infection Prevention and Control Program
Deficiencies
• CMS's Internal Controls Over Hospital Preparedness for Emerging
Infectious Disease Epidemics Such as Coronavirus Disease 2019
• Medicaid-Audit of Health and Safety Standards at Individual Supported
Living Facilities
• Health and Safety Standards in Social Services for Adults
• Medicaid Nursing Home Life Safety and Emergency Preparedness
Reviews
CMS Focused Workplans
Note: Represents reviews conducted by Office of Audit Services;
additional reviews are conducted by Office of Evaluation and Inspections
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• Considerations
• Paycheck Protection Program
• Medicare Accelerated and
Advance Payments
• CARES Act Provider Relief Fund
• FEMA Assistance
• State relief programs
• Each of these programs
has specific eligibility and
performance requirements,
including attestation and
documentation requirements.
Federal and State Assistance
Ensure the organization can demonstrate that it satisfies all eligibility requirements prior to application to any assistance program.
Action
Understand all conditions for use of funds, develop processes to ensure compliance with same.
Action
Develop and execute processes to track and document all fund uses.Action
Ensure completeness and accuracy of all reports submitted regarding use of funds; ensure timely and appropriate response to any queries from same.
Action
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• Considerations
• Privacy/security breaches
• Unauthorized use/disclosure
of PHI
• 42 CFR Part 2 Program (Part
2) – Substance Use Disorder
(SUD) Confidentiality and
Disclosure policies
HIPAA
Ensure a hospital’s documented process is in place to demonstrate that certain sharing of protected health information (PHI) outside of the HIPAA Privacy Rule requirements is applied to situations which required conditions.
Action
Ensure the use of a HIPAA-compliant communication, transmission, and social media solution and application of best practices that protect critical information and safeguard patient privacy.
Action
Thoroughly document and report any breach investigation within 60 days of discovery. Complete documentation and root cause analysis of a breach should also support attempts to prevent, control, and respond to the spread of COVID-19.
Action
Develop or update organizational processes to ensure the provisions of the CARES Act for 42 CFR Part 2 SUD information are in place.
Routinely audit use and disclosure of Part 2 information to ensure that the CARES Act provisions have been appropriately implemented.
Action
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• Considerations
• Numerous Section 1135 blanket
waivers of specific regulatory
requirements to ease
administrative burden
• Interim Final Rule easing other
requirements
• https://www.cms.gov/about-
cms/emergency-preparedness-
response-operations/current-
emergencies/coronavirus-
waivers
CMS Waivers and Flexibilities
Ensure managers are aware of those waivers and flexibilities applicable to their operations.
Action
Develop policies for documenting use of the waivers when changing established operations.
Action
Develop process for unwinding arrangements dependent upon waivers and flexibilities following the end of the COVID-19 PHE.
Action
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• Considerations
• Organization must have adequate
emergency disaster protocols
• Waiver Considerations
• CMS waivers address the
requirement to develop and
implement emergency
preparedness policies and
procedures for surge sites at
hospitals and Critical Access
Hospitals (CAHs).
• This addresses the current
requirements for a communication
plan that includes all staff, entities
providing services under the
arrangement, patients’ physicians,
other hospitals and CAHs, and
volunteers.
Emergency Disaster Protocols
Develop or update the emergency disaster protocol to ensure it is multi-disciplinary and multi-agency.
Action
Conduct tabletop exercises to test the protocols.Action
Revise protocols as necessary to adequately address emergency disaster plans and response.
Action
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• Considerations
• The organization has a
process for the relocation of
individuals for screening at
alternative locations, as well
as the transfer of individuals
who have not been stabilized.
EMTALA Waivers
Develop and implement a documented process that meets the requirements of the EMTALA Waiver if alternative locations will be used for screening pursuant to the state’s emergency preparedness plan.
Action
Develop and implement a documented process for the transfer of an individual who has not been stabilized, if the transfer is necessitated by the circumstances of the declared federal PHEfor the COVID-19 pandemic.
Action
Document both the EMTALA Waiver activation and any patient transfers in the medical record and monitor regularly to ensure waiver requirements are met.
Action
NOTE: While a facility can inform patients of alternative treatment locations, once a patient presents to an Emergency Department (ED), EMTALA applies, and the medical screening examination must be provided at that location.
Action
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• Considerations
• The organization has a process
in place to allow for provisional
credentialing to expedite the
ability to provide necessary
patient care services.
Provider Credentialing and Licensing
Develop and implement a process for expedited credentialing, orientation, and onboarding of supplemental staff or shared staff.
Action
Ensure the organization has a policy that establishes the threshold for use and priority listing for supplemental staff (e.g., shared organizational staff, followed by similarly credentialed and licensed staff, followed by Medical Reserve Corps, etc.).
Action
WAIVER CONSIDERATION: CMS waivers address the requirement that a physician or non-physician practitioner be licensed in the state in which he/she is furnishing services.
Action
The waivers also address the application fees for prospective and revalidating institutional providers, fingerprint-based criminal background checks, and on-site visits and reviews of providers or suppliers.
Action
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• Considerations
• The organization has a process in
place to accommodate provisions
for emergency provider enrollment
in Medicare in order to meet
patient care needs.
Medicare Provider Enrollment
Secure the necessary provider information to initiate temporary billing privileges in accordance with the Medicare Provider Enrollment Relief provisions.
Action
Ensure the organization has a process in place to document all emergency provisions used during the COVID-19 crisis, and complete an enrollment application for full Medicare billing privileges once the PHE declaration is lifted.
Action
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• Stark Law Waiver Considerations
• The organization has a plan in place to
address necessary changes in physician
compensation methodology that is based
on a productivity-based compensation
formula adversely affected by
postponement of elective surgeries and
decreased outpatient visits.
• This includes preparing employment
agreements and documentation of short-
term compensation arrangements with
physicians who are hired or redeployed
to help in the medical response crisis.
• The organization has a plan in place to
evaluate appropriate application of blanket
waivers to other physician relationships
including real estate, professional service
arrangements, and non-monetary
compensation.
Physician Financial Arrangements
Prepare for rapid decision-making for physician employment issues, including compensation adjustments, retention arrangements, hiring decisions, and patient care assignment changes.
Action
Ensure that all conditions of each blanket waiver are appropriately understood and satisfied in order to rely on the resulting flexibility and relief.
Action
Ensure reliance on any waiver or modifications to any process subject to the Stark Law and Anti-Kickback Statute has appropriate approvals and supporting documentation.
Action
WAIVER CONSIDERATION: Providers may request from CMS specific individual waivers to certain requirements under Stark, but must be able to address the dissolution of these actions upon the end of the PHE.
Action
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• Considerations
• The organization has a documented
process in place to provide for the
use of staff in alternative positions,
or the use of unlicensed staff as
allowed by state statute.
• The organization has a plan in
place to accommodate a dramatic
increase in patients entering the
facilities, as well as patients
needing to cancel appointments
and procedures, all requiring
additional patient access staff,
technology, personal protective
equipment (PPE), and training.
Alternative/Additional Use of Staff
Develop and implement a process to use available staff (i.e., in alternative positions and, as state executive orders allow, by engaging unlicensed temporary staff) where needed during the emergency period.
Action
Employ a robust monitoring program related to the use of staff in such a manner to ensure proper patient care is delivered and documented.
Action
Ensure the organization’s disaster plan provides for alternative staffing for patient access, as well as adaptable technology. Additionally, develop and provide training to re-allocated staff for patient access services.
Action
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• Considerations
• The organization has processes
in place that allow non-essential
employees to work from home
and ensure that confidential and
proprietary information is
safeguarded.
Telecommuting
Ensure the organization has a plan for resources, communications, expense reimbursement, etc.
Action
Review insurance policies (e.g., employee benefits, workers compensation, cyber, etc.) to ensure appropriate and adequate coverage.
Action
Confirm IT infrastructure can support remote work and that data privacy and security is ensured with work-from-home arrangements consistent with the organization’s information security policies and procedures.
Action
Implement additional auditing of privacy and security safeguards, and regularly provide employees critical reminders.
Action
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• Considerations
• The organization has a process
in place to pause face-to-face
research activities except those
that affect the safety and well-
being of the subjects, or those
related to COVID-19.
• The organization has a process
in place to review and approve
studies and funding related to
COVID-19 research.
Research Activities
Notify the affected individuals of the required pause in current research studies involving human subjects, as deemed appropriate based on COVID-19 guidance.
Action
Ensure a process is in place to review and approve research opportunities specifically related to COVID-19.
Action
Incorporate detailed auditing of COVID-19 studies into the compliance work plan to ensure that funding sources are appropriately vetted, new research programs are based on scientific and societal needs, and the study complies with existing clinical study requirements.
Action
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• Considerations
• The organization has processes in place
to meet the expanded use of telehealth,
including appropriate documentation and
the accurate use of procedure codes,
modifiers, and place of service.
• The organization has processes in place
to facilitate appropriate billing for all
COVID-19-related treatment.
• The organization has a process in place to
meet requirements to post its cash price
for COVID-19 testing on its public website.
• The organization has processes in place
to manage a significant increase in
uncompensated care and to track costs for
delivering COVID-19-related care for the
uninsured.
• The organization has a process to ensure
“balance billing” protocols for COVID-19-
related testing and treatment are in
accordance with regulatory guidance.
Documentation, Coding, and Billing
Implement processes to accurately provide telehealth and COVID-19-related services, including documentation, coding, and billing.
Action
Develop a plan to assist patients with financial clearance to determine if they are eligible for charity, Medicaid, or other insurance.
Action
For uninsured patients, track COVID-19-related testing and treatment costs for proper billing and reimbursement under the CARES Act.
Action
Review financial assistance policies to ensure that any adjustments made during a PHE are clearly delineated both as to application and the time period for the adjustment to be in place.
Action
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• Considerations
• Given the exigent circumstances
unique to COVID-19, the OIG
indicated that certain free or
reduced rate provisions present
a low risk of fraud and abuse
under the AKS and could
improve beneficiaries’ access to
medically necessary services.
Free/Reduced Rate Services and Items
Carefully review provisions of free or reduced-rate services and items, which will fill critical gaps due to COVID-19, but could be construed as violations of AKS and potentially implicate the Beneficiary Inducements CMP.
Action
Ensure these arrangements do not take into account referral volumes, do not provide referral incentives, and do not involve any ownership interests.
Action
Ensure documentation demonstrates: 1) patient care needs are directly related to the COVID-19 PHE; 2) the time period for the arrangement is limited to the COVID-19 PHE; and 3) the provisions are not contingent on referrals that may be reimbursable in whole or in part by the federal healthcare program, either during or after the COVID-19 PHE.
Action
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• Considerations
• The organization has a process
in place to collect data on
incidents (patients, visitors, etc.)
and associated events related
to COVID-19 exposure and
treatment in the Patient Safety
Evaluation System (PSES) to
identify issues of patient safety
and quality improvement to be
evaluated under the Patient
Safety Act.
PSO Incident Reporting
Evaluate and update the PSES intake tool to ensure that appropriate COVID-19 data is collected for analysis by the PSO.
Action
Ensure events are appropriately reported and analyzed for future patient safety improvements.
Action
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• Considerations
• The organization has a process
in place to protect against
faulty/inferior/unsafe products
and services and to confirm that
products offered by vendors are
registered with the Food and
Drug Administration (FDA).
• The organization has a process
in place to document any
exceptions made to its vendor
policies and purchasing
decisions.
Vendor Due Diligence
Ensure that products are registered with the FDA, with the exception of items temporarily permitted for emergency use in healthcare by the Centers for Disease Control (CDC), i.e., industrial N95s.
Action
Document all allowed exceptions to existing vendor policies and purchasing decisions, and communicate these to administration, medical staff, nursing staff, pharmacy staff, the purchasing department, and key stakeholders.
Action
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• Considerations
• The organization has a process
in place to detect email and
marketing scams related to
COVID-19.
Email and Marketing Schemes
Ensure policies and procedures are in place to monitor, identify, and protect important systems supporting COVID-19 response efforts.
Action
Examples include a workforce trained in using caution with email attachments and avoiding social engineering and phishing scams and the verification of authenticity of electronic data received by the organization through use of malware and virus protection software.
Action
Other examples include the recognition and use of trusted sources, such as government websites, for information, rather than unknown sources purporting to provide financial, product, and services assistance.
Action
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• Considerations
• The organization has a process in
place to monitor all avenues of
regulatory guidance affecting
activities during and post-pandemic.
Monitoring Regulatory Guidance
Ensure monitoring for updates, changes and new developments has been effectively assigned, that monitoring continues, and that updates are communicated and evaluated for applicability.
Action
Guidance for other areas subject to compliance implications is also available, including:
- Swing Beds
- Interoperability Rule flexibilities
- Data sharing with state and federal officials
- Infection control considerations
- Management of elective procedures
- Extension of quality and cost report filing deadlines
Action
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Managing Compliance Programs
and People Remotely
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Rethinking Historical Approaches…
Permanently?
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Rethinking Historical Approaches
Investigate
Assess EducateCommunicate
Evaluate Test
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• Review and update key policies and procedures to incorporate new
processes and situations created by telecommuting
• Evaluate compliance training processes and materials
• Develop and incorporate education focused on remote workforce; determine
what positions require training
• Test the awareness and efficacy of hotline reporting mechanisms
• Have reports gone up or down since significant % of workforce went remote?
• Is an awareness campaign needed?
• Evaluate how to stay connected with leadership and departments,
especially since walking around and being physically present/available
for “hallway chats” is limited or not an option
• Increase monitoring and check points to evaluate whether historical
controls are still working as intended
• Does having remote employees create need for changes of key controls?
Rethinking Historical Approaches
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• Update/modify processes for handling of complaints/investigations
remotely
• Continuum of risk/scenarios that can be investigated remotely versus those
that require in-person investigation
• Evaluate investigation work steps that will require modification when
conducted virtually including
• Scheduling/conducting interviews
• Ensuring parties are in setting conducive to confidential discussions, free of
disruptions or concern of being overheard
• Determine whether interviews will be recorded and if not, how to notify interviewee
that the discussion should not be separately recorded
• Train compliance team, other key managers on specific risks/considerations
Rethinking Historical Approaches
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Rethinking Historical Approaches
• Reeducate employees on key
policies that may be compromised
by remote workers
• Privacy policies
• Data security
• Protection of proprietary information
• What can/can’t be printed
• Document destruction
• Physical safeguards of home
office/organization’s information
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• Privacy and personal information considerations:
• Review existing privacy policies to ensure the policies cover the disclosure of
PII to governmental agencies for requested emergency purposes, including
public health.
• Consider what information an organization discloses if employees or
customers have tested COVID-19 positive.
• Data protection and cybersecurity considerations:
• With many employees working from home, there are increased cybersecurity
issues or risks.
• Consider infrastructure support, remote access requirements and policies,
training, and auditing.
• COVID-19 has opened a gate to hackers using the current circumstance
for nefarious purposes.
• Send regular security reminders to all employees and other relevant personal
to be vigilant against potential cyber-scams, phishing and attack.
Data Privacy, Protection, and Security
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• Once lockdowns lift around the country, compliance teams must tailor
preventative measures for the organization to:
• Reduce risks for employees returning to the workplace; and
• Respond rapidly and effectively if an infection occurs.
• As organizations develop plans for the return of staff, compliance
teams need to help determine the arrangements ensure that necessary
health and safety standards are met while ensuring compliance with
regulations.
• CDC and state and local health departments have guidance on the
issues to consider for that strategy of returning staff to the workplace.
Returning to Work
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More with Less – The Effects of Furloughs and
Layoffs on Compliance
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Traditional Compliance Program
Challenges
• Inadequate resources
• Technology (e.g. policy management system, COI software, training software)
• Budgets
• Staffing
• Board support
• Impact
• Compliance work plan challenges
• Increased organizational risk
• Staff burnout
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COVID-19 Compliance Program
Challenges
• Similar but added complexity…
• Decreased or frozen budgets
• Staffing furloughs or layoffs
• Distraction from compliance concerns due to pressing patient care matters
• Significant increase in compliance risks that exacerbate work plan challenges
• Increased organizational risk
• Staff wearing multiple hats that may not apply to compliance
• Staff burnout/fatigue at a different level
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Decreased Resources = Reassessment
• Compliance department and work plan re-evaluation required:
• Assess current skills of active compliance work force.
• Determine realignment of departmental responsibilities.
• Re-evaluate and re-prioritize work plan items based on risk. Incorporate new
high-risk areas, shift low-risk areas to “parking lot”.
• Present the modified work plan to the Board for evaluation and approval.
• Temporary or Permanent?
• Determine anticipated length of time operating under constrained resources.
• Evaluate need for, and ability to secure, external supplemental resources to
effectively mitigate risk.
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Interim Solutions, Long-term Impacts
• Collaborate with leaders responsible
for key risk areas:
• Who have they assigned to monitor
regulatory changes, operational impacts?
• What tools are they using to stay
current?
• How are they validating, sharing
information?
• What mechanism can be established so
compliance team is kept abreast of key
activities/changes, how they’re being
identified, managed, monitored?
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Interim Solutions, Long-term Impacts
• Review workplan to develop capacity for evaluating new risk areas:
• Who has subject matter expertise to assess risk?
• What information do they need to learn?
• Evaluate how the organization’s compliance needs will evolve due to
COVID-19.
• Example: HHS Provider Relief Funds = interdepartmental approach
• Compliance team
• Regulatory programs team
• Finance team
• Internal audit team
• Operations
• Billing and collections
• Patient registration
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Interim Solutions, Long-term Impacts
• Evaluate how to supplement compliance team with additional resources
to expand bandwidth, allow “highest and best use” of remaining
resources
• Outsource review of COI
• Contract review (regulatory compliance elements)
• Revising policies and procedures
• Draw on specific SME resources
• Ensure high-risk areas are not placed on the back burner
• Corporate Integrity Agreement process, monitoring and reporting requirements
• Monitoring and refunding overpayments
• Ensuring provider relief funds are used or returned appropriately
• Due diligence activities are conducted on transactions that continue to move
forward
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Post COVID-19
• Evaluate how “compliance shuffle” worked before returning to a
pre-COVID-19 state:
• Are there tools/processes/resources that should remain as part of a
go-forward plan?
• Were there areas where the compliance department was actually more
efficient, more impactful during the strain? How can this be harnessed and
carried forward?
• Were there silos that were torn down/new collaborations created that should
be fostered for the betterment of the organization?
• Did the department employ “precision medicine” resources to get the right
skill sets (internal or external) on key areas/issues, allowing individuals to
play to their strengths and contribute differently?
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Compliance Officer’s Role
During COVID
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Image Source: Shutterstock
Questions and Group Discussion
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A T L A N T A | K A N S A S C I T Y | K N O X V I L L E | N A S H V I L L E | T A M P A
pyapc.com
800.270.9629
Thank you!
Lori FoleyCMA, CHC®, PHR, SHRM-CP
Principal
Kristen DavidsonMHA, CCEP-I®, CHC®,
CPHQ, RHIA®
Manager
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