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2023 Compliatric Webinar Series - 340B Recertification and Audit Changes

Watch the Webinar Here: https://compliatric.com/340b-recertification-and-audit-changes/ Compliatric is excited to host the second of a two part 340B webinar series, presented by Ryan DiGiovanni, an Apexus Certified Expert (ACE) Pharmacist, President of EPL Health, and 340B Program Manager, Rush University Medical Center. This webinar will outline requirements and updates covered entities should be made aware of heading into annual recertification, as well as highlight key changes to HRSA’s audit data submission and review process.

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340B Recertification & Audit
Changes/Tips
Ryan DiGiovanni, PharmD, 340B ACE
ryan_digiovanni@rush.edu
Disclosures
• No conflict of interest
• Information provided should not be construed as legal advice.
Bio
Ryan DiGiovanni – PharmD, 340B ACE
Founder - EPL Health
• Build and support 340B compliance & operations for
covered entities (CE)
• Entities we serve: FQHC, FQHC-LA, DSH, CAH, RW
Clinics
340B Manager- Rush University Health System
• 2 Disproportionate Share Hospital (DSH)
• 1 Hemophilia Treatment Center (HTC)
• 700+ Contract Pharmacy
• 3 Third Party Administrators
340B Satellite Office
340B
Coordinator
Expansion &
Growth
All Vendor
Management
Compliance &
Audit
Consolidated
Reporting
Agenda
+ Hot Topics
+ Audit Trends & Readiness
+ 340B Data Request Review
Poll
1. What entity type are you?
a. Hospital
b. Grantee
2. What do we want to spend most of our time on?
a. 340B Hot Topics & HRSA Audit Impact
b. Annual Recertification
c. HRSA Audit Data Request List
Hot Topics: Timeline of Events
2019
Guidances Not Legally Binding
Trump Administration issued an executive
order (Federal Register, 84 Fed. Reg.
55235-55238 Oct 15, 2019) that rendered
guidance documents published by federal
agencies as non-binding and not legally
enforceable.
Manufacturer Restrictions Begin
Effective July 1, 2020, Eli Lilly
announces it will no longer sell
Cialis at 340B ceiling prices to
covered entities through contract
pharmacy arrangements
2020
2020
HRSA Loosens Audit Findings
The Government Accountability Office (GAO)
issues report, stating HRSA began to relax its
auditing standards, only issuing findings
non-compliance that are directly related to
340B Program Statute.
2022
Genesis v. Azar Appeal
Genesis appeal argued HRSA audit findings were
based on interpretation of ‘patient’ defined in guidance,
contradicting the plain language of the law and
overextended HRSA’s enforcement capability
HRSA ultimately reinstated Genesis in the 340B
Program, voided its audit, and the district court
dismissed the lawsuit.
2023
1st Ruling in favor of Manufacturers
U.S. Court of Appeals for the 3rd Circuit rule in favor
of Sanofi-Aventis U.S. v. HHS et al. Not required to
provide 340B price at contract pharmacy. Cases
raising similar legal questions are pending in the
District of Columbia and 7th Circuits.
Ad

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2023 Compliatric Webinar Series - 340B Recertification and Audit Changes

  • 1. 340B Recertification & Audit Changes/Tips Ryan DiGiovanni, PharmD, 340B ACE ryan_digiovanni@rush.edu
  • 2. Disclosures • No conflict of interest • Information provided should not be construed as legal advice.
  • 3. Bio Ryan DiGiovanni – PharmD, 340B ACE Founder - EPL Health • Build and support 340B compliance & operations for covered entities (CE) • Entities we serve: FQHC, FQHC-LA, DSH, CAH, RW Clinics 340B Manager- Rush University Health System • 2 Disproportionate Share Hospital (DSH) • 1 Hemophilia Treatment Center (HTC) • 700+ Contract Pharmacy • 3 Third Party Administrators 340B Satellite Office 340B Coordinator Expansion & Growth All Vendor Management Compliance & Audit Consolidated Reporting
  • 4. Agenda + Hot Topics + Audit Trends & Readiness + 340B Data Request Review
  • 5. Poll 1. What entity type are you? a. Hospital b. Grantee 2. What do we want to spend most of our time on? a. 340B Hot Topics & HRSA Audit Impact b. Annual Recertification c. HRSA Audit Data Request List
  • 6. Hot Topics: Timeline of Events 2019 Guidances Not Legally Binding Trump Administration issued an executive order (Federal Register, 84 Fed. Reg. 55235-55238 Oct 15, 2019) that rendered guidance documents published by federal agencies as non-binding and not legally enforceable. Manufacturer Restrictions Begin Effective July 1, 2020, Eli Lilly announces it will no longer sell Cialis at 340B ceiling prices to covered entities through contract pharmacy arrangements 2020 2020 HRSA Loosens Audit Findings The Government Accountability Office (GAO) issues report, stating HRSA began to relax its auditing standards, only issuing findings non-compliance that are directly related to 340B Program Statute. 2022 Genesis v. Azar Appeal Genesis appeal argued HRSA audit findings were based on interpretation of ‘patient’ defined in guidance, contradicting the plain language of the law and overextended HRSA’s enforcement capability HRSA ultimately reinstated Genesis in the 340B Program, voided its audit, and the district court dismissed the lawsuit. 2023 1st Ruling in favor of Manufacturers U.S. Court of Appeals for the 3rd Circuit rule in favor of Sanofi-Aventis U.S. v. HHS et al. Not required to provide 340B price at contract pharmacy. Cases raising similar legal questions are pending in the District of Columbia and 7th Circuits.
  • 7. Hot Topics: Genesis V Agar & Guidance on Patient Definition Diversion
  • 8. Hot Topics: Op-Ed ❖ Background/Discussion Currently, HRSA’s authority is limited only to program statutes and regulations* - Mega-guidance and other common guidelines (i.e. Patient Definition) are not enforceable findings during a HRSA audit* ❖ Tips/Warnings - May drive greater attention to enforceable laws/regulations. Recommend special attention to specific aspects of program: - Accuracy/Eligibility information in OPAIS database - Recertification/Registration - Policy & Procedure - annual review and update - Duplicate Discount Prevention - Medicaid Exclusion File, State Policy - Maintained auditable records - Compliance with HRSA Audit - *based on presentation date 02/21/2023. Statements outlined are opinion based and/or subject to change
  • 10. Recertification - General ❖ Background/Discussion - Annual recertification is mandatory for 340B covered entities - Authorizing Official & Primary Contact get email notifications ❖ Requirements - Must ensure all information is accurate and up to date - Must update and attest before recertification window ends - ONLY AO can Attest (PC can update/make changes) Entity Type Recertification Window FQHCs & Most Grantee January 30, 2023 - February 27, 2023 Hospitals Summer 2023 Title X family planning clinics, STD, TB clinics No dates yet
  • 11. Recertification - General ❖ Tips/Warnings - Have MCR/Grant documents ready for upload - Verify addresses match on eligibility forms to OPAIS - Ensure each registered site is still operational/eligible - Grantees: falls under scope of grant - Hospitals: outpatient charges/expenses on MCR lines 50-118* - Have you Medicaid billing numbers and/or NPI numbers ready - Ensure contact information for AO and PC is correct ❖ Tools/References - Get help: - ApexusAnswers@340bpvp.com - 888-340-2787 - Online Resources: - Recertifying a CE *FAQ ID: 4301. HRSA 340B FAQ Search (340bpvp.com)
  • 12. Start Session Go to links provided in Autorizing Official (AO) or Primary Contact (PC) email. Sign in to HRSA 340B OPAIS database (Office of Pharmacy Affairs 340B OPAIS (hrsa.gov)) to start. Recertification tasks will appear in My Dashboard section under ‘My Task’ tab’. Click on ‘Recertification’ Summary Page The recertification summary page will outline items for you that must be updated, and items that should be reviewed. “Update” = required, “Review” = Recommended. Read these then hit ‘Continue AO Signs & Attests After all information is updated and reviewed, the Authorizing Official must check the attestation box, and ‘Submit’ Go Through Each Tab - Go through each tab Qualification Info, Attachments Info, Medicaid Billing, Parent/Child. - Read any ‘update’ or ‘review’ messages. - Click the Edit link to review the details pages and make necessary updates.
  • 13. Recertification - Uploading Attachments ❖ Background/Discussion - This is usually the biggest issue requiring additional follow up from HRSA ❖ Tips/Warnings - Only Microsoft Excel (xlsx) and Adobe PDF formats are allowed. - File size is limited to 50MB. - Files must not be password protected. - Number of uploaded files must not exceed 10 files per submission ❖ Tools/References - ApexusAnswers@340bpvp.com - 888-340-2787 - Uploading Documents
  • 14. Recertification - Cost Report - If you change the entity's Qualification Information during recertification or if the most recent cost report is out of date, the system will prompt you to upload updated supporting documentation from the latest Medicare cost report. - If you change the entity’s Filing Date, and if the Filing Date is more than 5 months and 5 days after the Cost Reporting Period end date then the system will display a warning message and require you to upload the signed/dated Worksheet S from your latest filed Medicare Cost Report.
  • 15. Changing AO - Recertification The current AO or PC may submit an AO change request. Only an AO change can be requested in a Change Request when the entity is undergoing recertification. On the Covered Entity Details page, type the email address for the new AO and click the Search button.
  • 16. Medicaid - Recertification This information is used to populate the medicaid exclusion file ‘At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices? Yes = Carve-in, No = Carve out Duplicates cannot be created because upon the save in the Edit Medicaid and NPI Info by State pop-up window, the duplicates will be ignored. However, if duplicates already exist, it is up to the AO and PC to correct them either by associating each duplicated number with a different State or removing the duplicates from the current State.
  • 18. HRSA Audit Agenda What to Expect: Introductions – Consider one person to coordinate if remote Scripted Reason for Audit Agenda timing will vary Auditor will review housekeeping items that may still need to be uploaded Begin with a general overview of program and auditor questions Sampling, Transaction Testing, Provider Review, Claim Review Follow Up On Any Outstanding Items Closing
  • 19. HRSA Selection Criteria Maximum number of random samples selected is 56 28 samples from largest universe If any universe is 300 or less there will never be more than 10% 5 samples are judgmental which will always come from the largest dataset ❖ Background/Discussion Since 2020, HRSA has implemented consistent data sampling practices:
  • 20. Provider Administered Drugs Sample • Time of Dispense or Administration • Patient Status • Drug Order and Dose • Provider Name - If Health Care Professional Stance utilized, show documentation to substantiate care • Location – If not from an eligible location, demonstrate the continuum of care via primary care visit or referral documentation. • Payer
  • 21. Retail Claims Drug Sample • Date of Visit to Substantiate Care • Location Where Prescription Was Written • Prescription Order • Medication Present in Med list • Medication Present in Provider Documentation • Referral Origination and Care Note Back (if applicable, best practice) • Payer – If in-House Retail and FFS Medicaid will want to see clarification codes
  • 22. Billing Claim Form Review ❖ Background/Discussion If carving-in Medicaid, expect auditor to review billing - Will need to verify NPI-UB04 Box 56 & CMS 1500 Box 33 - Confirmation of any state modifiers ❖ Requirements - Only required to upload Medicaid FFS claim
  • 24. 340B Audit Data Request List ❖ Background/Discussion Reviewed and updated beginning of every fiscal year ❖ Requirements/New Information 1. Policy & Procedures 2. Eligibility 3. 340B Universe for Sample Period 4. Provider List 5. Purchasing 6. Contract Pharmacy 7. Entity-Owned Pharmacy 8. Self-Disclosures 9. Medicaid Billing 10. Re-audit ❖ Tips/Warnings ❖ Tools/References - 340B Data Request List Sample pdf
  • 25. 1. Policies & Procedures ❖ Background/Discussion - All CE’s: loosened eligibility of providers, locations and acceptable patient records during public health emergency - Hospitals: Definition of eligible site when location is not on the MCR yet or for special circumstance ❖ Requirement - Policy & Procedures must reflect the covered entities eligible location definition, provider and record-keeping requirements to allow for this ❖ Tips/Warnings - Ensure P&P’s updated to provide entity this wiggle room - Auditor may ask about emergency activations of locations within sampling period ❖ Tools/References - HRSA FAQ ID: 4301 - Public Health Emergency Considerations
  • 26. 2.B. Eligibility - Hospitals ❖ Background/Discussion - More transparency of site eligibility when reviewing sample data ❖ Requirement New in FY23: Section 2B - Include all applicable Medicare Cost Reports - Most recently filed MCR for the start of the audit period; - MCR used at the time of the last recertification; and - MCR filed since the start of the sample period through the date of audit - The encrypted signature on Worksheet S must be provided with all MCRs -
  • 27. 2.G. Eligibility - Hospitals ❖ New Requirements 2.C - Item G Added FY21 - The 340B ID - Name of each offsite outpatient facility as identified on OPAIS - Address of the off-site outpatient facility - Worksheets A & C: Line Number and Cost Center Description - Trial balance name and department code/account - The location code or shorthand used to identify the site in the electronic health record (EHR) - Indicate if 340B drugs are utilized during encounters at the site -
  • 28. 2.E. Eligibility - Hospitals ❖ Background/Discussion HRSA wants hospital eligibility documents to be easier to decipher ❖ New Requirements 2.E. Hospitals Requiring Contract with State or Local Government - New FY22: must highlight the following in the contract: ■ Provision whereby indigent care provided by Hospital ■ Name of Hospital and Government Agency ■ Signatures of Hospital and Government Agency ■ Effective Dates of the Contract Private non-profit and hospitals granted government powers must prove non-profit status documentation. - IRS Form 990, Hospital Charter, Articles of incorporation, Bylaws, 501(c)(3)
  • 29. 2. Eligibility - Grantees ❖ Background/Discussion - Auditor will likely go through services provided at each associated clinic during an opening conference. - Crosswalks create bridge to cipher eligible locations listed on OPAIS to EHR record locations to Billing/Shipping Locations - Will make for seamless preparation and audit ❖ Requirements - Notice of Grant Award and/or sub grantee documentation - EHB Forms 5A and 5B. 5C is not on list but have available as well. - EHB Crosswalk – Include a list of locations where health care services are provided for which the grantee deems itself responsible ❖ Tips/Warnings Creating EHB Crosswalk: 1. Start with OPAIS extract 2. Crosswalk each associated site’s physical address, verify they match the EHB 3. Add bill to and ship to columns and populate with appropriate addresses 4. Add location code or shorthand to identify the site in the health record 5. Include additional columns to indicate if actively purchasing 340B drugs and add billing numbers if carving in Medicaid. ❖ Tools/References - Apexus Sample Data Request - 340B Crosswalk - Basic Template
  • 30. 3.A. Universe & Program Narrative ❖ Requirements 3.A: Not New - Include a narrative describing the methodology and system or software used to gather the data: note any limitations, exclusions, and inclusions (e.g., reversals, direct purchases, etc.) Universe Methodology/System/ Software Report Name(s) Notes Mixed Use Mixed Use TPA Includes Reversals and direct purchases, explain limitations, or any exclusions Child Site EHR or TPA In-House Rx TPA Contract Rx TPA
  • 31. 3.A. Universe & Program Narrative ❖ New Requirements 3A. - Define each area of service on the spreadsheet(s) with column headings name and indicate which area the spreadsheet represents ❖ Tips/Warnings Copy the column headers and add into the program narrative Create a key for abbreviations and/or unknown terms - For example: - CSN = Contact Serial Number = Unique Patient ID - MRN = Medical Record Number - ESN = Encounter Serial Number
  • 32. 3.A. Universe & Program Narrative ❖ Tips/Warnings - Review ALL data prior to upload - Remove non-covered outpatient drugs - exclude limiting definition drugs (vaccines), orphan drugs - pvp-value added drugs (use pvp price file for this) - Only report data elements that have been asked for - REMOVE PHI (just Rx number, MRN, or tracking number) - BUT Keep copies of original records on file for better cross-walking during audit period
  • 33. 4. Provider List ❖ Requirements - Name - NPI - Employment type (Employed, Resident, Contract) - Start Date - End Date ❖ Tips/Warnings - Create ‘Type 2’ dimension- table to address any potential gaps in employment and/or change in employment type - Be prepared to show the auditor proof of employment, contract, or credentialing for providers during the onsite/remote audit Provider Map ID First Name Last Name NPI Employment Type Start Date End Date isActive 1 John Doe 1234564789 Dedicated 1/1/2010 3/1/2015 N 2 John Doe 1234564789 Contracted 3/2/2015 Y
  • 34. 5. Purchasing Docs ❖ Requirements - List all accounts – for all universes – including if applicable (340B, GPO, WAC, CSOS) by 340B ID - Include wholesaler name - Include a column for bill to and ship to which will assist in OPAIS address verification - Provide Invoice example for each account – embed or list corresponding file name - Provide all purchases (340B ONLY) - embed or list corresponding spreadsheet name ❖ Tips/Warnings - Update on a rolling 6-month basis to be in HRSA audit ready state - Create ‘Type 2’ dimension- table to address any potential gaps in employment and/or change in employment type
  • 35. 5. Purchasing Crosswalk Example Clinic / Hospital / Retail Account Location 340B ID Ship To Address Bill To Address ACCOUN T # DESIGNATI ON WHOLESALE R Invoice Name Reference Purchasing Record Off-Site Clinic CE Physicians Group HRSA ID 336 S. Jefferson 113 W. Hickory XYZ 340B Add Name 5.B. HRSA ID Invoice 7805XXX 5.C. HRSA ID Wholesaler Purchasing Record Off-Site Clinic CE Physicians Group HRSA ID 336 S. Jefferson 113 W. Hickory XYZ GPO Add Name 5.B. HRSA ID Invoice 387XXXXX NA Hospital CE Hospital HRSA ID 113 W. Hickory Street 113 W. Hickory XYZ GPO Add Name 5.B. Mixed Use GPO Invoice 995XXXXX NA Hospital CE Hospital HRSA ID 113 W. Hickory Street 113 W. Hickory XYZ 340B Add Name 5.B. HRSA ID 340B Invoice 3087XXXXXX 5.C. HRSA ID Wholesaler Purchasing Record
  • 36. 6A. Contract Pharmacy Crosswalk ❖ New Requirements - 6.A. must disclose whether pharmacy is being used by the covered entity - 6.C. Provide last Independent Audit of Contract Pharmacies - 6.D. Provide supporting documentation of internal contract pharmacy audits during start of sample period through date of audit. ❖ Tips/Warnings - Create ‘Type 2’ dimension- table 1. Can use OPAIS Extract of all contact pharmacies to get you started and minimize to the following columns: - 340B ID, Pharmacy Name, Address 1, Address 2, City, State, Zip, Contract Approval Date 2. Then add the following additional columns: - TPA, Pay on: Dispense or Replenishment, True Up Terms, Utilized or Not Utilized, Wholesaler, Account Number, Invoice, Contract Name
  • 37. CONTRACT PHARMACY CROSSWALK EXAMPLE 340 B ID Retail Account Location Address Contract Approval Date TPA Pay on True Up Active Wholesaler Account # Invoice Name Contract Name HRS A ID Contract Pharmacy Uptown Drug Store N Bus hwy date from extract Macro Replenis hment 180 Utilized Cardinal XYZ or 123 CAHXXXXXX-00 copy of invoice List contract file name when first registered or embed copy HRS A ID Contract Pharmacy Drug Stores on the Boulevard S BLVD Ste A date from extract Macro Replenis hment 180 Utilized Cardinal XYZ or 124 CAHXXXXXX-00 copy of invoice List contract file name when first registered HRS A ID Contract Pharmacy Walgreens #0XYZ S BLVD date from extract Walgree ns Dispens e 60 Utilized Amerisource XYZ or 126 CAHXXXXXX-00 Walgreens copy of invoice List contract file name when first registered HRS A ID Contract Pharmacy PHY S Jefferso n date from extract ScriptPr o Dispens e 60 Utilized Amerisource XYZ or 127 CAHXXXXXX-00 Walgreens copy of invoice List contract file name when first registered HRS A ID Contract Pharmacy Walmart 001 Grand Ave date from extract Macro Replenis hment 180 Utilized McKesson XYZ or 128 CAHXXXXXX-00 Walmart Invoice_AXXXXX List contract file name when first registered HRS A ID Contract Pharmacy Walmart 005 Range RD date from extract Macro Replenis hment 180 Not Utilized McKesson XYZ or 130 Not Utilized List contract file name when first registered if in audit window, if not list term date or NA
  • 38. 7. Entity-Owned Pharmacies ❖ New Requirements Provide a list of pharmacies, other than contract pharmacies utilized during the start of the sample period through the audit start date. - Pharmacy name and address - Whether pharmacy is located within a registered off-site facility/grant-associated Site Type of pharmacy (Retail/Community, Infusion, Specialty, Compounding, Mixed-Use) - Documentation to demonstrate ownership - Pharmacy license, Business license, Certificate of liability insurance, or Listing of pharmacy on the CEs grant or MCR and corresponding trial balance ❖ Tips/Warnings - Also adding in OPAIS Pharmacy ID, OPAIS Contract ID, Pharmacy NPI number would provide more efficient tracking and reference ID columns. - Can use these columns for Xlookup/Vlookup functions to audit pharmacy dispensing data across all pharmacies/TPAs. ❖ Tools/References 340B Crosswalk - Basic Template
  • 39. 9. Medicaid Documents ❖ Requirements - Provide Medicaid FFS billing document for each covered entity site (340B ID) that carves in - Every NPI, every Medicaid number, for EVERY 340B ID 340B ID State State Requirements NPI(s) State assigned Medicaid number(s) Medicaid FFS Claim Form CAH12345-00 MN UD 123 XYZ [Embedded document] CAH12345-01 MN UD 1234 XYZ [Embedded document] CAH12345-02 MN UD 12345 XYZ [Embedded document]
  • 40. Key Takeaway - 340B DRL - 340B Program Narrative, with data methodology table, and column header crosswalk - Location Crosswalk - Purchasing Crosswalk - Contract Pharmacy Crosswalk - Medicaid Crosswalk
  • 42. 340B News: Genesis v Agar Genesis Healthcare Inc. v Alex Azar: Genesis, an FQHC, removed from 340B program after 340B audit findings of Diversion. (qualified rx’s as 340B eligible from ‘non-eligible locations’) Bullet Points: • After being removed from 340B, Genesis filed suite that argued that the audit findings, which were based on adherence to HRSA’s interpretation of ‘patient’ defined in guidance, contradict the plain language of the law and overextended HRSA’s enforcement capability • HRSA ultimately reinstated Genesis in the 340B Program, voided its audit, and the district court dismissed the lawsuit. • Genesis has since appealed the dismissal, pressing the court for a declaratory judgment that the 340B patient definition issued through guidance is illegal. Oral arguments for the appellate case were heard in March 2022. Historical perspective regarding the case: • In 2019, the Trump Administration issued an executive order (Federal Register, 84 Fed. Reg. 55235-55238 Oct 15, 2019) that rendered guidance documents published by federal agencies as non-binding and not legally enforceable. • Mfg have taken advantage by restricting 340B drugs through contract pharmacy channels, as outlined in non-binding guidance • The Government Accountability Office (GAO) issued a report in December 2020 on HRSA’s efforts to oversee CE compliance with 340B Program requirements. The report noted that, starting in the fall of 2019, HRSA began to relax its auditing standards by which it would only issue findings for areas of non-compliance that are directly related to requirements stipulated in the 340B Program statute. • 340B Statute: https://www.hrsa.gov/sites/default/files/hrsa/rural-health/phs-act-section-340b.pdf
  • 43. 340B News: Genesis v Agar Conclusion: Broadening the patient definition may provide CEs with significant value in terms of 340B savings optimization, and may be permissible according to law, given the lack of specificity of “patient definition” outlined in 340B Program statute and regulations. Considerations: • Elements of case are directly applied to grantee, not a hospital • Current HRSA audit standards reflect the agency’s limited enforcement authority, HOWEVER, these standards could evolve should they receive rule-making authority and/or the ability to enforce 340B Program guidance. Potential Next Steps: • Assess for scenarios where a “continuum of care” relationship may apply • Review non-reimbursable hospital departments (e.g., Line 190 clinics) that may be integral to the CE. • Quantify the financial impact of broadening the Patient definition • Ensure any modifications to patient definition are clearly articulated in policies and procedures.