Navigating Audits – Key Information to a Successful Outcome
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Transcript of Navigating Audits – Key Information to a Successful Outcome
Navigating Audits – Key Information to a Successful Outcome
Eric Hartkopf, PharmDAudit AnalystPAAS National®
Disclosure and Conflict of Interest
I am an employee of PAAS National®, an audit assistance company.
I will not discuss off-label and/or investigational use in my presentation.
Pharmacist ObjectivesAt the conclusion of this program, the pharmacist will be able to:
1. Identify three common audit discrepancies and how to avoid them.
2. Describe prevention strategies that pharmacists can incorporate into daily workflow to decrease audit risk.
3. Discuss how pharmacists can use pharmacy management software reports to perform self-audits.
Technician ObjectivesAt the conclusion of this program, the pharmacist will be able to:1. Identify three common audit discrepancies and how to
avoid them.
2. Describe prevention strategies that pharmacy technicians can incorporate into daily workflow to decrease audit risk.
3. Discuss how pharmacy technicians can use pharmacy management software reports to perform self-audits.
Key Points and Major Takeaways
• Key Points are in bold and underlined
• Major Takeaways are in bold and red
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Why so many audits?
• Escalating Healthcare costs• Opioid Epidemic• Contractual Requirement• Fraud, Waste & Abuse• Common Billing Errors• Data Analytics/Outliers• PBM Revenue Source = $$$
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Audit Trends from 2014-2018Desk % Onsite % Central Review % Invoice* %
2014 63 27 9 12015 67 26 7 12016 74 20 4 22017 79 16 2 2
2018 (projected) 83 13 2 1
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• *Many invoice audits are “in addition to” desk/onsite audit• 5 year trend is a 52% increase in audits overall
Source: Internal data analysis
30,000 foot view
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Prescription•Do you have a prescription?•Is prescription legal/valid per
state and federal laws?
Data Entry & Filling•Did you fill and bill
accurately?
Dispensing•Do you have proof of
dispensing?•Do you have proof of copay
collection?
Other•Did you purchase enough
inventory from an appropriate source?
Common Audit Discrepancies
Prescription• Missing/Invalid Rx• Altered Rx
Data Entry• Overbilled Quantity• Refill Too Soon• Incorrect DAW code
Dispensing• Missing/Invalid
Signature Log• Dispensed > 14 days• Copay Collection
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Learning Assessment Q#1
Which of the following are common audit discrepancies?a. Missing Prescriptionb. Refill Too Soonc. No proof of dispensingd. All of the above
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Audit Algorithms ≠ Random
• Historical Billing/Documentation Errors• Day Supply• DAW
• Historical Fraud Targets• Controlled Substances – “Pill Mills”• Compounds
• Zip code analysis• Patient• Prescriber• "Telemedicine"
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Types of Audits
Desk Onsite Invoice
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Sample Audit Flow
Notification Pharmacy Submission Initial Results
Pharmacy Appeal Final Results Pharmacy
Second Appeal
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Desk Audit
• Provide copies ONLY• Review for legibility and plan compliance• Label each page with Rx #• Organize per the audit request• Make a copy for yourself• “Receive by” vs. “postmark by”• Certified Mail > Fax
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Onsite Audit – Unannounced
• Typically a “compliance” or “credentialing” audit• Validate auditor (photo ID)• Take care of your patients first!• Auditor only shown their claims and documents
(HIPAA)• Proactive outreach – educate pharmacies BEFORE
there is an FWA compliance issue
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Onsite Audit – Unannounced• Limited Rx/siglog review
(<5 each)• FWA Compliance
• ANNUAL CMS training• MONTHLY OIG/GSA exclusion
checks• P&Ps – return to stock,
partial fills, outdates on shelf
• Licensure• CMS 10147 - updated
version for use as of July 1, 2018
• HIPAA Compliance• PHI disposal
• Fridge – temperature/food• Pharmacy ownership
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Onsite Audit – Pre-Audit
• EVERY DAY IS A “PRE-AUDIT”• Review PBM Provider Manual• Self-Audits
• High risk claims (details later on)• Previous errors
• Try to make a routine task – don’t wait to start until after you get audit notice
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Onsite Audit – Pre-Audit• Notification – At least 7 days notice per audit law
• MO Audit Law – not in first 3 business days, 2-year lookback, no extrapolation
• Plan Staffing to accommodate• Plan Location – minimize disruption and PHI access• Retrieve requested documents from storage
• Masked list = Rx # 1234XX• Consult Audit Assistance Resource
Source: MO Chapter 338.600 http://revisor.mo.gov/main/OneSection.aspx?section=338.600&bid=18141&hl
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Onsite Audit – Day of Audit Overview
• Emphasis on document retrieval• Prescriptions – scans are usually fine• Don’t forget about notes in computer system (e.g. DAW,
UAD sig)• Signature logs
• Compliance elements as previously discussed• Observations of premises and workflow
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Onsite Audit – Day of Audit Process
• Validate auditor (photo ID), visitor sign-in sheet• PHARMACY STAFF pull Rx and siglogs in “plain
view”• Ask Questions• Take Notes• Exit Interview
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Invoice Audit – Overview• Increasing in frequency• Concerns about legitimate inventory
• DSCSA aka Track and Trace• Gray Market• Counterfeit• Diversion of foreign products – e.g. Abbott 2015 Lawsuit
• Total Inventory purchased vs. Inventory billed to specific PBM• Net purchases (less returns, credits)
• Aggregate time period (e.g. 12-18 months)• All NDCs vs. specific NDCs• #1 audit type to lead to Network Termination
Source: https://www.lexislegalnews.com/articles/3136
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Invoice Audit – Pre-Audit
1. Request Extension 2. Forward request to ALL
wholesalers• Request copies of what is
sent• Pricing information is NOT
necessary• More problems with
smaller wholesalers3. PBMs want files sent
directly by wholesalers
4. Each PBM considers a different grace period prior to the date range (e.g. 30-90 days)
5. Provide copies directly if:• Wholesaler is closed• Pharmacy purchases
6. Consult your Audit Assistance Resource
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Workflow Prevention Strategies – Practical Tips
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Rx Drop Off Data Entry Filling Verification Cashier
Rx Drop Off
• Verify apparent alterations• Clarify “use as directed” for insulin or topicals with
patient or prescriber• Implement Rx scanning if possible • Suggested Clinical Note Format:
1. Who you spoke with2. When you spoke with them3. What you spoke about4. Who is writing the note
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Data Entry• Verify correct NCPDP billing unit (EA, GM, ML)
• Be cautious with syringes and “kits”
• Quantity “1” = smallest package size unless confirmed otherwise
• Some products must be dispensed in original container – see NLM DailyMed for product labeling
• Day supply – estimate as per quantity and SIG, must submit accurately, call PBM helpdesk for override if smallest unbreakable package• Document calculations on prescription
• DAW codes – only submit if supported by documentationSource: NLM DailyMed (https://dailymed.nlm.nih.gov/dailymed/index.cfm)
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Filling
• Match NDC on stock bottle against billing label (including package size) using barcode technology if possible
• Confirm quantity prepared matches billing label
• If time allows spot check DAW, Day Supply, Origin Code
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Verification• Match NDC on stock bottle against billing label
(including package size) using barcode technology if possible
• Double check day supply estimate as per documented calculations• Pay close attention to insulin, topicals, eye drops, inhalers
• Verify Data Entry elements such as DAW, Day Supply, Origin Code• Suggest adding to “backslap” if doing paper verification
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Cashier (Dispensing)• Conduct Return to Stock every 10-14 days, using pharmacy
management software “workflow” if possible• Document any unique exceptions where Rx was dispensed > 14 days• If patient promises to come “next week”, then reverse/rebill/relabel
to give more time to maintain compliance• Obtain patient signature and date, implement electronic capture if
possible• If mailing, make sure that Rx # is “tied to” carrier tracking ID #• Collect Copay at dispensing, implement POS itemized
system if possible• In-house charge accounts must have good accounting practices
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Learning Assessment Q#2
Which of the following is an audit prevention strategy that a pharmacist may do on a daily basis?a. Compare day supply submitted with the prescription
documentation during prescription verificationb. Analyze all DAW claims billed over last 30 days to
ensure supporting documentation existsc. Work with software vendor to build alerts for drugs
that must be dispensed in original container
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Learning Assessment Q#3
Which of the following is NOT an audit prevention strategy that a pharmacy technician may do on a daily basis?a. Confirm use as directed instructions with patients
and document on the prescriptionb. Match NDC on stock bottle versus NDC on the
adjudicated claimc. Analyze all DAW claims billed over last 30 days to
ensure supporting documentation exists
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“Top Ten” Audit Problems1. Day Supply – Insulin2. Day Supply – Topicals3. Day Supply – Inhalers4. Day Supply – Eye drops5. DAW6. Controlled Substance Prescriptions7. E-Prescriptions8. Transfer Prescriptions9. Compound Prescriptions10.Proof of Dispensing/Copay Collection
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1. Day Supply – Insulin• 1 box of pens (15 mL)
• In general do NOT have to “break the box”
• Submit accurate DS if possible
• Do not refill early• Obtain Max Daily Dose and
add a Clinical Note
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Rx #1Insulin Lispro U-100 Pen15 mLUAD per sliding scale
7/29/18 per Kate, RN max daily dose = 30 units EEH
2. Day Supply – Topicals• Submit accurate DS if
possible• Mathematical instructions
for use• Grams per application (if one
area only)
• Max Daily Dose per MD or
expected day supply
• List of affected areas + Finger
Tip Unit (FTU) Method
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Rx #2 Calcipotriene 0.005% cream360 GMAAA BID
7/29/18 per Josie, RN affected area
= both hands and feet EEH
Finger Tip Unit (FTU) Method• 1 FTU » 0.5 gram (adult)• 1 FTU covers one hand
(front/back)
Body Surface # of FTUsHand 1
Foot 1
Arm + Hand 4 (3+1)
Leg + Foot 8 (7+1)
Buttocks 4
Trunk (front or back) 8 each
Face & Neck 2.5
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3. Day Supply – Inhalers• Submit accurate DS if possible• Do not refill early• Strategies
• Call for DS override• Add note to sig field (e.g. 60 ds)• Train staff to watch for refill
intervals
• If patient requests early assess circumstances and document
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Rx #3 Fluticasone Inhaler 110 mcg #1Sig 1 puff BID
Calculation: 120 puffs / 2 per day = 60 ds EEH, max plan limit = 30 ds
4. Day Supply – Eye Drops• Submit accurate DS if possible• In General
• 20 drop/mL for solution
• 15 drop/mL for suspension
• PBMs have their own “estimates”
• CVS/Caremark® 15
• Express Scripts® 16
• OptumRx® 15
• Document any patient factors that may impact ability to dose accurately (e.g. Parkinson)
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Rx #4 Brimonidine tartrate 0.1% Ophthalmic Solution10 mLSig 1 drop OU TID
Calculation:
PBM is CVS/Caremark® per BIN #
10 ml x 15 drop/mL = 150 drops total
150 / 6 = 25 ds
5. DAW
• Values 0-9• 0 = Default for brand and generic• 1 = Brand per Prescriber• 2 = Brand per Patient• Generally avoid 3-8• 9 = Brand per Plan• DOCUMENTATION must support
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6. Controlled SubstancesFederal Law3 elements as per 21 CFR 1306.05(a)
• Patient Address• MD Address• DEA number
State Law(s)• Where applicable
Buprenorphine/naloxone – DATA 2000 Waiver ID aka “X DEA number” in addition, not in replace of
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Rx #5 7/11/2018Homer Simpson742 Evergreen Terrace, Springfield
Buprenorphine/naloxone 8/2 mg film#601 film SL BID + 0 refills
Dr. Nick123 Main St, SpringfieldAB1234567 XB1234567
7. E-Prescriptions
• Quantity “1” = smallest package size
• DAW – default? (false positives – furosemide, fluticasone/salmeterol diskus)• Sig field vs. free text
• Day Supply• Be cautious about DS field when conflict with quantity/Sig
calculation
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8. Transfer Prescriptions• General Requirements
1. “Copy” or “Transfer”2. Transferring pharmacy info – RPh,
pharmacy, address, phone, DEA # 3. Rx info4. Rx history – Rx #, first/last fill,
original/remaining refills5. Your info – date of transfer, RPh
• State Specific• MO Breg 20 CSR 2220-2.120
• Suggest using a dedicated transfer Rx pad with all required elements
• Data Entry – original date vs. transfer date
Source: MO Breg 20 CSR 2220-2.120 https://www.sos.mo.gov/cmsimages/adrules/csr/current/20csr/20c2220-2.pdf8/27/18 41
9. Compounds
• Rx must match compound log AND Claim• NDCs• Quantities
• Ingredient strengths assumed to be “final” unless specified• E.g. in lidocaine 5% ointment
• Base QS amount – make sure software does not overbill• LOE codes 11-15
• Be careful with defaults
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10. Proof of Dispensing & Copay CollectionProof of DispensingElements
1. Rx #2. Date of Service3. Signature of
Patient/Representative
• “Mail”, “Drive Thru” or “Delivery” will NOT be sufficient
Copay Collection• Contracts require collection
WITH PROOF (limited exceptions)
• In-house charge accounts
• Manufacturer Coupons• Medicaid/Medicare• Caremark: non-FDA approved
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Self-AuditPharmacy Management Software Reports• Develop an internal “self-audit” program
• Basic = review daily dispensing logs• Sophisticated = weekly or monthly review of high risk claims
• Which claims are worth looking for proactively?• "Top Ten“• Set a minimum price threshold to reduce sample size (e.g. > $100)
• Review documentation vs. billing• Quantity, Day Supply, DAW, Prescriber ID, Origin Code, Level of
Effort, RTS Override Codes
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Corrective Action Measures
Common Discrepancy
Identified
Root Cause Evaluation
New/Revised P&PStaff Training
Self-Audit
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Learning Assessment Q#4
Which of the following is a data field that a pharmacist may review when performing a self-audit with software report?a. DAWb. Origin Codec. Day Supplyd. All of the above
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Learning Assessment Q#5
Which of the following drugs should a pharmacy technician focus on when performing a self-audit with software report?a. Insulinb. Topicalsc. Generic anti-depressantsd. Transfer Prescriptionse. A, B and Df. All of the Above
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