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www.compliantfqhc.com
Continuous Compliance Series- It’s not JUST an OSV Prep
COMPLIATRIC WEBINAR SERIES
Presented by : Jennifer Genua-McDaniel
jgenua@genuaconsulting.com
Contracts/Subawards (Chapter 12) and
Conflict of Interest (Chapter 13)
 This presentation is not endorsed by Management
Strategists Consulting Group (MSCG)
 This presentation is not endorsed by Health
Resources Services Administration (HRSA) or Bureau
of Primary Health Care (BPHC)
 Not employed by MSCG or BPHC
 Independent Consultant who is contracted to do
Operational Site Visits (OSV)s and Technical
Assistance (TA)
 Not intended to provide legal advice
 Continuous compliance = HRSA funding
◦ Monthly focus on various HRSA Compliance Chapters
 Do something different than just “plain, old,
boring Operational Site Visit preparation”
◦ Generative approach
 What are the requirements?
 Do we understand them?
 Can we take it to the next level and use compliance for
excellence?
 Virtual OSVs are here
 Understand the requirements and why they are
important
◦ Every month HRSA Compliance chapter requirements
presented
 Methods to maintain continuous compliance
◦ Without doing it at the last minute, or when told, “hey
we’re having an OSV in 3 months”
 How to use the requirements in everyday practice
◦ Make your Community Health Center awesome!
 Compliance:
◦ How does a health center utilize their federal funds
 Agreement through a contract or subaward
 Do you contract a substantive programmatic work
 Entire key Management team, majority of health care providers from a single
entity
 Health Center Program Compliance Manual, Contracts-(See Footnotes)
◦ Procurement procedures that reflect applicable State, local,
federal, tribal laws and regulations for procurement actions paid
for in whole or in part under the Federal award based on 45CFR
Part 75
 Cost or price analysis
 Comply with 45 CFR 75.328
 Open and fair competition and if not:
 Item is only available from a single source
 Public Emergency
 Non-competitive is authorized by HRSA
 Competition is determined to be inadequate after getting a number of
sources
 Compliance:
◦ Must oversee contractors to ensure their performance is
in accordance with terms, conditions, and compliant with
Federal requirements
◦ Must maintain financial records, supporting
documentation, etc., pertinent to the Health Center
Program for a period of 3 years from the final date of
submission to HHS
◦ Subawards (HRSA approval only)
 Subrecipient supports the Health Center’s scope of project
 Must comply with ALL HRSA Program Requirements
 Health Center must monitor the subrecipient and keep records
 Contracts
◦ Ensure your protocols have the citation to 45CFR Part
75, Subpart E: Cost Principals
◦ Appropriate supporting documentation for contracts that
used federal funds $25,000 or more:
 What was the rational for the procurement method?
 What type of contract type? Sole source? Competition?
 If a contract was rejected or selected, why?
 What was the basis for the contract type?
 Contracts
◦ What do I need to put in them??
◦ Contracts to include all contracts in scope, Column
II (remember: Column III are MOUs/MOAs)
◦ Contract requirements also within other program
requirements (list not inclusive)
 Required and Additional Services
 Clinical Staffing
 Sliding Fee
 Contracts (what HRSA requires)
◦ List of the entities involved
 Who is the contract with?
◦ List of services to be provided
 Description of services
◦ How will the health center pay for the services
 Monthly, Quarterly, Will there be an invoice?
◦ How will the service be documented in the patient
record?
 Will the contractor send a treatment plan? Will it be
documented in the health center’s health record?
 Contracts
◦ Assurances of Credentialing and Privileging
 “Provider agrees to provide Health Center with assurances that,
during the term of this contract agreement, it, and as
applicable, its individual healthcare practitioners furnishing the
services to health center patients are and will remain: 1) duly
licensed, certified and/or otherwise qualified to provide services
hereunder, with appropriate training, education and experience
in their particular field; 2) appropriately credentialed and
privileged; and 3) eligible to participate in federal health care
programs including Medicaid and Medicare”
◦ Sliding Fee Discount Program (SFDP)
 Discounts are provided in a manner that meets all Health Center
Program requirements (ex. health center applies its own sliding
fee discount to amounts owed by eligible patients; contract
contains specific sliding fee provisions; contracted services are
provided by another health center which applies a sliding fee
discount that meets structural requirements
 Contracts
◦ Monitoring contract performance
 Ensuring that the contract is being carried out
 What documents will be requested?
 What happens if there is an issue with the service provided?
◦ Data reporting expectations and intervals
 Will data will be provided to know the contract is going well?
Are you going to use invoices and cross reference payment
as a reporting expectation? What about treatment plans
received back in a certain period?
◦ Provisions for record retention and access, audit and
property management
 Who owns the record? How long do you keep medical
records? What about audits and access to records?
 How to keep this requirement compliant
◦ Create a checklist of HRSA requirements for
contracts
◦ Use the HRSA Center Self-Assessment Worksheet
for Form 5A: Services Provided
◦ https://bphc.hrsa.gov/sites/default/files/bphc/programrequirements/scope/fo
rm-5a-self-assessment-review.pdf
 PDF fillable form to add contract names
 Ensure contracts are not expired, or monitor expiry
date by using a system or a platform
 How to keep this requirement compliant
◦ Work with legal counsel for standard contract
templates to ensure other contractual language
◦ Create addendums if needed for contracts (Quest,
LabCorp, etc.)
 If addendums are added, provide the entire contract
and addendums for review during site visits
◦ Keep contracts in one place
Contracts help health centers provide services we may
not be able to offer in house
Ensure they protect the health center and provide
clarity to roles and responsibilities
Can help to avoid expensive and potential risk and
disputes
 Source: Instagram
 Compliance:
◦ Written standard of conduct covering conflict of interests
engaged in the selection, award or administration of
contract that comply with all Federal requirements
◦ No employee, officer, board member or agent of the
health center may participate in the selection or
administration of a contract supported by a federal
award if he or she has a real or apparent conflict of
interest
◦
 Compliance:
◦ Standards of Conduct:
 Continuous Compliance
◦ Things to consider:
 What is the WRITTEN process for disclosing real or apparent
conflicts?
 How does the health center inform all** of the conflict of
interest?
◦ During a site visit, there will be a review of any conflicts of
interest in the past 3 years. If there was a COI, did the
health center follow the standards of conduct, including
WRITTEN disclosure?
** This applies to employees, officers, board members, and agents**
 A conflict of interest does not mean that a
health center is out of compliance
◦ Follow the policies and procedures that your health
center has
◦ Declare and document the conflict
 Governing Board of Directors
◦ Not to be a part of the discussion or vote if there is
a conflict
◦ Documented in the meeting minutes of board
member abstaining due to conflict
 Be mindful of conflicts in the organization
◦ Sometimes it’s difficult in smaller rural areas
◦ Certain companies may have an
expertise/equipment that a health center needs
◦ Have employees sign conflict of interest statements
 Keep in Human Resource (HR) files
 A133 annual audits require Conflict of
Interest Statements signed by the Board and
Senior Team
 https://bphc.hrsa.gov/programrequirements/compliancemanual/index.
html
 Health Center Self-Assessment Worksheet for Form 5A: Services
Provided (hrsa.gov)
 https://www.healthcenterinfo.org/
 https://bphc.hrsa.gov/programrequirements/svprotocol
 MOU-vs-Contracts_FINAL_20120117.pdf (changelabsolutions.org)
 Jennifer Genua-McDaniel, BA (Hons), CHCEF
◦ Genua Consulting, LLC
◦ jgenua@genuaconsulting.com

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Compliatric continuous compliance series chapters 12 and 13

  • 1. www.compliantfqhc.com Continuous Compliance Series- It’s not JUST an OSV Prep COMPLIATRIC WEBINAR SERIES Presented by : Jennifer Genua-McDaniel jgenua@genuaconsulting.com
  • 2. Contracts/Subawards (Chapter 12) and Conflict of Interest (Chapter 13)
  • 3.
  • 4.  This presentation is not endorsed by Management Strategists Consulting Group (MSCG)  This presentation is not endorsed by Health Resources Services Administration (HRSA) or Bureau of Primary Health Care (BPHC)  Not employed by MSCG or BPHC  Independent Consultant who is contracted to do Operational Site Visits (OSV)s and Technical Assistance (TA)  Not intended to provide legal advice
  • 5.  Continuous compliance = HRSA funding ◦ Monthly focus on various HRSA Compliance Chapters  Do something different than just “plain, old, boring Operational Site Visit preparation” ◦ Generative approach  What are the requirements?  Do we understand them?  Can we take it to the next level and use compliance for excellence?  Virtual OSVs are here
  • 6.  Understand the requirements and why they are important ◦ Every month HRSA Compliance chapter requirements presented  Methods to maintain continuous compliance ◦ Without doing it at the last minute, or when told, “hey we’re having an OSV in 3 months”  How to use the requirements in everyday practice ◦ Make your Community Health Center awesome!
  • 7.  Compliance: ◦ How does a health center utilize their federal funds  Agreement through a contract or subaward  Do you contract a substantive programmatic work  Entire key Management team, majority of health care providers from a single entity  Health Center Program Compliance Manual, Contracts-(See Footnotes) ◦ Procurement procedures that reflect applicable State, local, federal, tribal laws and regulations for procurement actions paid for in whole or in part under the Federal award based on 45CFR Part 75  Cost or price analysis  Comply with 45 CFR 75.328  Open and fair competition and if not:  Item is only available from a single source  Public Emergency  Non-competitive is authorized by HRSA  Competition is determined to be inadequate after getting a number of sources
  • 8.  Compliance: ◦ Must oversee contractors to ensure their performance is in accordance with terms, conditions, and compliant with Federal requirements ◦ Must maintain financial records, supporting documentation, etc., pertinent to the Health Center Program for a period of 3 years from the final date of submission to HHS ◦ Subawards (HRSA approval only)  Subrecipient supports the Health Center’s scope of project  Must comply with ALL HRSA Program Requirements  Health Center must monitor the subrecipient and keep records
  • 9.  Contracts ◦ Ensure your protocols have the citation to 45CFR Part 75, Subpart E: Cost Principals ◦ Appropriate supporting documentation for contracts that used federal funds $25,000 or more:  What was the rational for the procurement method?  What type of contract type? Sole source? Competition?  If a contract was rejected or selected, why?  What was the basis for the contract type?
  • 10.
  • 11.  Contracts ◦ What do I need to put in them?? ◦ Contracts to include all contracts in scope, Column II (remember: Column III are MOUs/MOAs) ◦ Contract requirements also within other program requirements (list not inclusive)  Required and Additional Services  Clinical Staffing  Sliding Fee
  • 12.  Contracts (what HRSA requires) ◦ List of the entities involved  Who is the contract with? ◦ List of services to be provided  Description of services ◦ How will the health center pay for the services  Monthly, Quarterly, Will there be an invoice? ◦ How will the service be documented in the patient record?  Will the contractor send a treatment plan? Will it be documented in the health center’s health record?
  • 13.  Contracts ◦ Assurances of Credentialing and Privileging  “Provider agrees to provide Health Center with assurances that, during the term of this contract agreement, it, and as applicable, its individual healthcare practitioners furnishing the services to health center patients are and will remain: 1) duly licensed, certified and/or otherwise qualified to provide services hereunder, with appropriate training, education and experience in their particular field; 2) appropriately credentialed and privileged; and 3) eligible to participate in federal health care programs including Medicaid and Medicare” ◦ Sliding Fee Discount Program (SFDP)  Discounts are provided in a manner that meets all Health Center Program requirements (ex. health center applies its own sliding fee discount to amounts owed by eligible patients; contract contains specific sliding fee provisions; contracted services are provided by another health center which applies a sliding fee discount that meets structural requirements
  • 14.  Contracts ◦ Monitoring contract performance  Ensuring that the contract is being carried out  What documents will be requested?  What happens if there is an issue with the service provided? ◦ Data reporting expectations and intervals  Will data will be provided to know the contract is going well? Are you going to use invoices and cross reference payment as a reporting expectation? What about treatment plans received back in a certain period? ◦ Provisions for record retention and access, audit and property management  Who owns the record? How long do you keep medical records? What about audits and access to records?
  • 15.  How to keep this requirement compliant ◦ Create a checklist of HRSA requirements for contracts ◦ Use the HRSA Center Self-Assessment Worksheet for Form 5A: Services Provided ◦ https://bphc.hrsa.gov/sites/default/files/bphc/programrequirements/scope/fo rm-5a-self-assessment-review.pdf  PDF fillable form to add contract names  Ensure contracts are not expired, or monitor expiry date by using a system or a platform
  • 16.  How to keep this requirement compliant ◦ Work with legal counsel for standard contract templates to ensure other contractual language ◦ Create addendums if needed for contracts (Quest, LabCorp, etc.)  If addendums are added, provide the entire contract and addendums for review during site visits ◦ Keep contracts in one place
  • 17. Contracts help health centers provide services we may not be able to offer in house Ensure they protect the health center and provide clarity to roles and responsibilities Can help to avoid expensive and potential risk and disputes
  • 19.  Compliance: ◦ Written standard of conduct covering conflict of interests engaged in the selection, award or administration of contract that comply with all Federal requirements ◦ No employee, officer, board member or agent of the health center may participate in the selection or administration of a contract supported by a federal award if he or she has a real or apparent conflict of interest ◦
  • 21.  Continuous Compliance ◦ Things to consider:  What is the WRITTEN process for disclosing real or apparent conflicts?  How does the health center inform all** of the conflict of interest? ◦ During a site visit, there will be a review of any conflicts of interest in the past 3 years. If there was a COI, did the health center follow the standards of conduct, including WRITTEN disclosure? ** This applies to employees, officers, board members, and agents**
  • 22.  A conflict of interest does not mean that a health center is out of compliance ◦ Follow the policies and procedures that your health center has ◦ Declare and document the conflict  Governing Board of Directors ◦ Not to be a part of the discussion or vote if there is a conflict ◦ Documented in the meeting minutes of board member abstaining due to conflict
  • 23.  Be mindful of conflicts in the organization ◦ Sometimes it’s difficult in smaller rural areas ◦ Certain companies may have an expertise/equipment that a health center needs ◦ Have employees sign conflict of interest statements  Keep in Human Resource (HR) files  A133 annual audits require Conflict of Interest Statements signed by the Board and Senior Team
  • 24.  https://bphc.hrsa.gov/programrequirements/compliancemanual/index. html  Health Center Self-Assessment Worksheet for Form 5A: Services Provided (hrsa.gov)  https://www.healthcenterinfo.org/  https://bphc.hrsa.gov/programrequirements/svprotocol  MOU-vs-Contracts_FINAL_20120117.pdf (changelabsolutions.org)
  • 25.  Jennifer Genua-McDaniel, BA (Hons), CHCEF ◦ Genua Consulting, LLC ◦ jgenua@genuaconsulting.com