HRSA Audit – Survivors or Casualties? September 18, 2017 HRSA Audit – Survivors or Casualties?

HRSA Audit Paul Limberis, RPh, Pharmacy Manager University of Colorado Hemophilia Center Dan Dalton, RPh, Program Manager UNC Hemophilia Treatment Center Pharmacy

HTC – HRSA Audit Process As we have learned, HRSA is undertaking additional program integrity measures related to participation in the 340B Drug Pricing Program to ensure compliance with program requirements. This session will help explain the process of notification of an audit, preparation tips, the auditing process, & final reports.

HRSA Audit Process Notification Data Request Assembling the information for the auditor(s). Conference Call Day of Audit Final Report – Audit Findings

HRSA Audit Notification Notification sent to Authorizing Official & The Primary Contact Per 42 USC256b(a)(5)(C), HRSA has the authority to perform audits of a covered entity’s compliance with 340Program requirements. HRSA has contracted with the Bizzell Group, LLC to perform the audits of covered entities. Basics of the audit process

340B Program Audit Obtain an understanding of the entity’s policies, procedures & drug distribution system Review the entity’s eligibility status, including GPO prohibition as appropriate. Review drug procurement & distribution to determine whether the entity provided 340B drugs to appropriate patients as defined by Section 340B(2)(5)(B) of the PHSA. Determine whether the entity properly prevented duplicate discounts as required by Section 340B(a)(5)(A) of the PHSA.

The Bizzell Group Requests & Preparation Call Enclosed lockable working space for up to 3 staff. Internet access for 3 computers. Access to telephone, fax, & photo copier. Parking for up to two vehicles. Access to all financial, transactional documents & patient information related to the 340B Program. Introductory call with the Bizzell Group – account administrator & the auditor(s). Explanation of the audit process, date set, & download of information requested prior to audit.

Next Comes the Data Request Secure portal through NIH set up by Bizzell for the CE to download data. Each category may have up to 12 different data elements requested.

Organizing the Data Request by Category Policies & procedures Medicare cost report 340B drug orders or prescriptions Proof of employment, contracts, credentialing List of CE’s wholesalers & 340B drugs Listing of contract pharmacies Copy of any self-disclosures made to OPA List of all accounts A list of all clinics & locations Listing of all Medicaid & NPI numbers For hospitals Notice of Grant Award

1. Policies & Procedures CE registrations/recertification – 340B database up-to-date Description of procurement process Prevention of GPO violations as applicable Definition of covered outpatient drugs & any exceptions CE’s process for conducting oversight of its contract pharmacy(ies) 340B inventory accounting including replenishment/accumulation (NDC matching) Prevention of diversion at CE & contract pharmacy Mechanism to prevent duplicate discounts (carve-in or carve-out) When & how CE would self-disclose & definition of material breach

2. Medicare Cost Report Most recently filed Medicare cost report & trial balance documentation if applicable.

3. 340B Drug Orders or Prescriptions Listing of all 340B orders/prescriptions during 6 month sampling period – electronic format to include: Unique identifying number – Rx number Drug/Product name/NDC Acquisition price Type of account the drug was purchased through & associated 340B ID number Quantity issued Patient ID number Payer (Medicaid) Ordering provider

3. 340B Drug Orders or Prescriptions – Cont. Location site the 340B drug was administered/ordered/prescribed. Whether the drug was dispensed or used, reversed, or returned to stock. Description of the 340B Universe – narrative describing the methodology by which data was gathered & any limitations or exclusions. A sample of these prescriptions will be selected for testing while the audit team is on site. Individual records will need to be available in either electronic or paper format

4. Employment, contracts and credentialing verification CE should be prepared to show the auditor proof of employment, contract or credentialing for providers during the audit

5. Listing of wholesalers & 340B drug purchase orders A listing of CE’s wholesalers and 340B drug purchase orders made between dates of selected time frame, including price paid.

6. Contract Pharmacies A listing of contract pharmacies utilized & the current contracts individually identifying each contract pharmacy.

7. Self-disclosures A copy of any self-disclosures made to the OPA since the beginning of the audit timeframe.

8. Purchasing Accounts & Listing of Clinics/Locations A listing of all accounts used to purchase drugs for the parent & off-site outpatient facilities, including locations dispensing or distributing 340B drugs & a description of the applicable pricing (340B, GPO, WAC, CSOS, Other)

9. A List of all Clinics & Locations A listing of all clinics & locations where health care services are provided to individuals for which the CE deems itself responsible for the health care services provided for purposes of meeting 340B eligibility

10. Medicaid billing & NPI numbers A listing of all Medicaid billing numbers & NPI numbers utilized to bill Medicaid for 340B Drugs

11. Hospitals For hospitals – if the hospital has a contract with state or local government to provide healthcare services to low income individuals, provide a copy of that contract Hospitals

12. For Grantees For grantees (Ryan Whites, CHCs, FQHCs, FQHCLAs, FPs, STDs, TBs, HTCs) – provide Notice of Grant Award (NGA) or sub-grantee documentation.

Day of Audit Opening conference with Auditor Introductions with team Tour of Facility/Pharmacy Office Set up with computers & screens. Audit of selected charts Identified PHS sales Patient eligibility Drug-NDC Related NDC to purchase/account North Carolina – Scanned requested documents Delivery confirmation Work order (detailing NDC, units, etc.) Original Prescription Denver - Replenishment Model – PHS Reconciliation Report

Day of Audit – Cont. Exit Review

Post Audit – Additional Requests North Carolina – No additional requests Denver – Requested NGA of Sub-Award – Existing award ended 5/31/2017. New award not received.

Final Report - Findings Chapel Hill On-site audit: 5/24/2017 Final report received: 9/11/2017 Diversion: Each sampled prescription met all patient eligibility requirements. HRSA found no evidence of diversion Duplicate discount: HRSA Medicaid Exclusion File correctly reflects UNC’s billing practices with respect to Medicaid billing Finding 1: Incorrect 340B database record Finding 2: UNC’s written contract pharmacy agreement listed information inconsistent with 340B database record UNC must submit a CAP (corrective action plan) regardless if UNC is currently compliant Area for Improvement: HRSA recommends UNC review and update comprehensive written 340B Program policies & procedures

Final Report - Findings Denver – official HRSA OPA notification received 9/1/2017 Diversion - Each sampled prescription met all patient eligibility requirements. HRSA found no evidence of diversion Duplicate Discounts – HRSA Medicaid Exclusion File correctly reflects UCHC’s billing practices with respect to Medicaid billing

Final Report – Cont. Denver Our Sub-Award end date was 5/31/2017. The Audit was 6/20/2017. The new Sub-Award has yet to be approved & noticed. Finding 1 – THE PERFECT TIMING OF A STORM! During the audit, HRSA found that UCHC failed to meet eligibility requirements as required by section 340B(a)(5)(G) of the PHSA, which constitutes an audit finding. At the time of audit, UCHC was unable to provide the new grant & therefore fails to meet this eligibility requirement. OPA will remove UCHC from the 340B program no sooner than 30 days. UCHC will not be removed from the 340B program, if UCHC can demonstrate to HRSA it is currently in compliance with a receipt of grant. Due to ineligibility, UCHC is liable for repayment to manufacturers for any 340B drugs dispensed or prescriptions deemed 340B eligible which originated from UCHC, while in violation of the eligibility requirement, June 1, 2017 to present.