Transcript 340 B Audit

340B Audit Experience
Todd Karpinski, PharmD, MS, FASHP
Chief Pharmacy Officer
Froedtert & Medical College of Wisconsin
Objectives
• Outline the preparatory process for the 340B HRSA
audit
• Discuss the two day, on-site visit:
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Areas of focus
Discussion points during the audit process
Issues identified during the audit
Recommendations from the auditors
• Provide “tips” and “lessons learned” from the overall
audit process
Froedtert Hospital
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550 bed academic medical center
24,000 annual admissions
>140,000 patient days
Disproportionate share hospital
– 17.25% (FY2012)
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Affiliated with Medical College of Wisconsin
Only Level I trauma center in Southeastern Wisconsin
Major referral center: 40 specialties and subspecialties
>220 Pharmacy FTE’s
• Administration, Pharmacists, Technicians, EPIC® team
How do we support the intent of the 340B program?
Froedtert Hospital’s community benefit framework is to improve the quality of life in the communities we
serve through health care programs and services that are measureable, accessible and culturally appropriate;
recognizing the greatest impact is in Milwaukee’s underserved, urban population.
The Setting:
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U.S. 2010 Census: Milwaukee is #4 in poverty among the nation’s cities
In Milwaukee County, 30% are on Medicaid and 15% are uninsured
Our Investments in 2011:
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$34 million uncompensated care
$41 million in government shortfalls
Over 10,000 patient accounts adjusted for charity care
$400,000 annual support to FQHC’s and a $2 million pledge for capital support
Over $58 million in health professions education, including college and high school
scholarships / internships for underrepresented students
Community Benefit from Pharmacy
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Charity Care
Medication Management Home Delivery
Diabetes Smart Start Program
Medication Collection Program
Sharps Collection Program
Medication Repository
Discharge Program (implemented 9/2011)
Ambulatory Care pharmacists
Blood pressure cuffs (Newly Transplanted Patients)
Froedtert Hospital 340B
Timeline
2012
1995
Enrollment in 340B
2008
Expansion of Ambulatory Clinics
Contract Pharmacy
Cancer Center Growth
AUDIT
1999
2011
Expansion in Outpatient Pharmacy
Expansion of Infusion
Contract Pharmacy - Background
• On September 5th, 2010, HRSA published new guidelines
stating covered entities would no longer be limited to the
number of contract pharmacies.
• Entities partner with outside pharmacies to connect
qualifying patients with 340B medications
– Identification via shared patient and provider data
– Inventory via "Bill To - Ship To” wholesale
arrangements
• Entity-Contract Pharmacy relationship types :
– Direct Contracting with Pharmacy
– Contracting through 340B vendor with Pharmacy
Contract Pharmacy - Reinvest
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Inventory compliance technician
Patient assistance programs
Indigent care fund
Ambulatory care pharmacists dedicated to
transitions of care
Notification of the Audit
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June 18th , 2012 - Receive HRSA audit
notification via email
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Assess compliance of the covered
entity
1. Is eligible to participate in the 340B
Program
2. Has sold or provided 340B covered
drugs to persons who are not eligible
patients
3. Has the proper controls in place to
prevent and detect instances of
diversion and duplicate discounts.
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HRSA audit will include (at a
minimum)
1. Review of the facility’s policies,
procedures and processes that
pertain to 340B medications
2. Verification of internal controls in
place to prevent diversion and
duplicate discounts;
3. Testing, on a sample basis,
transactions that pertain to 340B
medications.
What did we do to prepare?
• Formed Froedtert Hospital 340B Team:
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Legal
Corporate Compliance
Finance Leadership
Pharmacy Leadership
• Scheduled weekly meetings within pharmacy
• Reached out to other colleagues/organizations
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SNPHA
Other 340B audited institutions
Wholesaler partner
Apexus
What did we do to prepare?
1. Apexus Self-Assessment Gap Analysis
What did we do to prepare?
2. Identified “Gaps” and divided workload
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Created stoplight report to establish deadlines and
track progress
Data Request
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Eight unique data elements were requested
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Policies and procedures
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Froedtert Hospital’s Medicare Cost Report
340B Drug Orders or Prescriptions Report of all 340B orders/prescriptions issued between
1/1/12 and 6/30/12
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Purchasing, Ordering, Invoice Processing, Inventory, 340B replenishment, Medicaid billing, contract
pharmacy
Unique identifying number, drug name, acquisition price, quantity, patient id, payer, and provider
Contact with the State Medicaid Prescription Drug Program
Listing of providers eligible to write 340B prescriptions
Current 340B pharmaceutical inventory listing including the most recent physical inventory
count and reconciliation
Report of all 340B drug purchase orders made between January 1, 2012 and June 30, 2012,
including price paid
Listing of contract pharmacies utilized, and the current contracts
Submitted data within one week of receiving the request
The Audit - Day 1
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Kick-off meeting
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Attendees: Pharmacy, Legal, Corporate
Compliance, Finance
Overview of Froedtert Hospital
Review of the audit visit
Tour of Pharmacies
– Outpatient pharmacies
– Day Hospital
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65 orders randomly selected for
on-site review
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5 orders from high cost medications
10 orders from contract pharmacies
20 orders from outpatient pharmacies
30 orders from HOD areas
Accumulators
Purchasing via Rx Works
The Audit – Day 1
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Retail/Contract Pharmacy Orders (30 total)
– Reviewed specific data fields for each order:
• Patient eligibility via electronic system? (Epic)
– Date of the prescription match the visit date?
– Patient have multiple visits?
• Provider eligibility?
– Reference to the Provider list
The Audit – Day 2
HOD Orders (35 total)
The Audit – Day 2
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Contract Pharmacy questions
Central Pharmacy Tour
Duplicate Discounts – Medicaid
Policy / Procedure Review
Provider Eligibility
Outstanding Items
Days After the Visit
Final Report from HRSA
How do we Maintain Compliance???
• In FY2012, one FTE technician was approved to
maintain 340B compliance by conducting internal
audits
– Responsibilities include:
• Conduct quarterly audits of contract pharmacies
• Evaluate and implement cost savings opportunities
• Coordinate purchasing for split inventory within internal
pharmacies
• Conduct self-audits of 340B pharmacy operations on a
quarterly basis
How do we Maintain Compliance???
• Audit 1: Compliance Validation
– Confirm presence of all covered entities and accuracy
of information; verify contact information including
phone and email information, Medicaid exclusion
information and ship to / bill to information. This
must include signoff by finance and legal.
– Completed annually
How do we Maintain Compliance???
• Audit 2: Prescription Eligibility Review
– Review 15 of the most expensive and 10 of the least
expensive (penny priced) dispenses within each of
the 340B eligible outpatient pharmacies. Review will
consist of verifying patient eligibility and provider
eligibility. Any variances are corrected and
documented on the 340B audit report
– Completed daily
How do we Maintain Compliance???
• Audit 3: Physician Data Base Maintenance
– Perform a monthly assessment of the accuracy of the
prescriber database to ensure proper designation. Any
variances are corrected and documented on the 340B Audit
Report.
• Audit 4: Accumulated Against Purchased (5 drugs)
– Verify that the correct quantity is purchased on the 340B
accounts based on the quantity that was processed in the
accumulator.
– Completed monthly
How do we Maintain Compliance???
• Audit 5: Purchasing Volume Analysis
– Purchasing volume for each account is reviewed to
ensure purchases have been made on the correct
account. Significant changes in purchase volume
are reviewed for appropriateness. Any variance are
corrected, using credit and rebill if necessary, and
documented on the 340B Audit Report.
– Monitor WAC / GPO / 340b spend
How do we Maintain Compliance???
• Audit 6: HOD Mixed Use – ED patients Admitted
vs. Not Admitted
– Review 25 patients from mixed use areas which the
splitting software for 340B drug purchase. Check
status to ensure patient status was Outpatient and
eligible for 340B purchase. Any variances are
corrected and documented on the 340B Audit Report.
– Completed monthly
How do we Maintain Compliance???
• Audit 7: Accumulator vs. Expected
– Verify accuracy of NDCs in the accumulator.
Compare accumulator expected purchases,
actual purchases, wholesaler purchases, and
proper account ordering.
– Complete monthly
How do we Maintain Compliance with
Contract Pharmacy???
• Audit 1: Patient Eligibility
– From the vendor’s report, choose 20 patients to audit. Select patients
who are filling the prescription for the first time. Select patients that have
multiple first fills prescriptions written by different prescribers. Verify
each patient in EPIC to ensure visit was completed by an eligible provider.
– Completed daily
• Audit 2: Hardcopy Prescription Request
– Request 20 prescription hardcopies from vendor. Verify patient and
provider eligibility. Verify that dispenses were accumulated appropriately.
– Completed monthly
How do we Maintain Compliance with
Contract Pharmacy???
• Audit 3: Vendor Prescriber Audit
– Evaluate each provider used to dispense 340B eligible prescriptions
for inclusion on eligible provider list. Eligibility is based on NPI
number.
– Updated provider eligibility list is sent each month
– Completed monthly
Hot button 340B issues
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GPO exclusion
Continued Audit preparedness
Employee prescriptions
Contract pharmacy
Lessons Learned
• Understand!
– Work with national organizations
– Network with other covered entities
– Utilize internal resources
• Be proactive!
– Review and understand Polices & Procedures
– Review audit process with key stakeholders
• Stay engaged!
– Continue to measure and test compliance
Questions?