Many PBMs DO NOT require a diagnosis code to be on the prescription or to submit the diagnosis code at the time of adjudication. However, it is important that the correct product is being dispensed for the proper diagnosis.

In the December 2023 Newsline, Zepbound^® (tirzepatide) Means Decreased Audit Risk…Right?, off-label uses of GLP-1 products were discussed. Medicare part D plans require that drugs are prescribed for medically accepted indications. Other PBMs have language in the Provider Manuals that define “clean claims” as one that is used for a medically accepted indication or outlines “appropriate dispensing practices”.  The chart below summarizes the current diagnoses for the approved GLP-1 products.

PAAS Tips:

• PAAS has written many Newsline articles regarding GLP-1 billing tips and recommendations – use ‘GLP-1’ in the Newsline Archive search box to pull up historical articles, and consider the articles listed below
  • Diagnosis Restricted? Documentation Required! (June 2024)
  • Best Practices for Dispensing GLP-1 Medications and Reducing Recoupment Risk (May 2023)

For example, some manufacturers have specific guidance for drops/mL due to a viscosity and drop size difference (e.g., Miebo^® [272 drops/3 mL], Vevye^® [200 drops/2 mL], and Vyzulta^® [81 drops/2.5 mL]), and you should calculate the days’ supply based on the manufacturers’ guidance.

Additionally, some eyedrops have a specific beyond use date in Section 16 Storage and Handling of the product labeling (e.g., AzaSite^® [14 days], Rocklatan^® [42 days], Rhopressa^® [42 days], Vyzulta^® [56 days], Xalatan^® [42 days]) and cannot have a days’ supply greater than the beyond use date. Do not assume that all eyedrops have a beyond use date of 28 days. This is NOT true in most cases.

If a prescriber indicates that patient should discard the eyedrop after using it for ’X’ number of days, this must be explicitly spelled out in the directions to the patient. For example, eye drops that are to be used in the right eye for two weeks after surgery then discarded for a new bottle to be used for the left eye should clearly indicate this in the directions before billing a 14-day supply. If multiple package sizes of the product exist, use the smallest bottle closest to the treatment duration as possible. The PBM will not pay for a patient to discard the remainder of a 15 mL bottle when a 5 mL bottle would have sufficed.

PAAS Tips:

• There is no industry accepted conversion for Gel or Ointment products
• Follow the individual PBM published guidelines when billing days’ supply
• OptumRx is the only PBM the explicitly states you may use treatment duration (e.g., “Use for ten days”) as the days’ supply
• The quantity prescribed should contain a unit of measure that corresponds to the billing unit; however, if written for a quantity of “1 bottle”, it should be interpreted as the smallest package size
• Login to the Member Portal under “Days’ Supply Charts” to find the most current version of PAAS’ Eye Drop Chart with major PBM drops per mL ratios
• Download the PAAS National^® Rx Days’ Supply Calculator from the App Store or Google Play
• Review the November 2024 article, 2024 Self-Audit Series #9: Eye Drop Days’ Supply for additional guidance

When used for ESRD patients, these oral-only medications will now be covered by Medicare Part B under the ESRD Prospective Payment System (PPS) bundled payment to dialysis facilities and should NOT be billed by pharmacies to a Medicare patient’s Part D plan (pharmacies will also not be able to bill Medicare B). If pharmacies are looking to continuing dispensing these medications, advanced coordination with dialysis facilities will be required to ensure pharmacies receive reimbursement.

Part D claims may reject with the following NCPDP reject codes:

• 75>Prior Authorization Required
• 569>Provide Notice: Medicare Prescription Drug Coverage and Your Rights
• A4>This product may be covered under the Medicare-B Bundled Payment to an ESRD Dialysis Facility

If Part D claims do not reject and pharmacy bills Part D incorrectly, then there will likely be future coordination of benefit (COB) “audits” where the Part D plan recoups the pharmacy payment, leaving the pharmacy to reconcile with the dialysis facility after the fact. PAAS National^® already sees these types of retroactive, COB audits when claims were billed to Part D but “should have” been billed to Part A for patients residing in a nursing home on a covered stay.

Phosphate binders remain coverable under Part D for other medically accepted indications for patients not on dialysis for ESRD. Pharmacies may want to obtain (and document) diagnosis codes to support these claims.

Numerous organizations, including NCPA, the American Society of Consultant Pharmacists (ASCP), and the American Society of Nephrology (ASN) provided feedback to CMS that this change in payment policy will negatively affect patients as many dialysis facilities do not have an in-house pharmacy and may supply these medications without the expertise of a pharmacist.

PAAS Tips:

• Educate billing staff about the likely rejects for phosphate binder medications for Part D patients
• Coordinate with dialysis facilities to ensure continuity of patient care and payment for pharmacy services

• Quantity: Unclear quantities and/or missing clear units of measure should be clarified with the prescriber’s office. Auditors look for mL, pens, boxes, or units, especially with highly targeted injectables. In addition, the quantity of “1” cannot be assumed when multiple package sizes are available.
  • See the December 2024 Newsline article, Why the Unit of Measure Matters in Audits: A Small Factor with Big Consequences
• NDC: The NDC reflected on an electronic prescription is considered “representative” according to NCPDP.  The Representative NDC Use in Electronic Prescribing Fact Sheet indicates “The representative NDCis not intended to infer specificity or preference to the embedded manufacturer/labeler”; therefore, determining which product to dispense cannot be solely based on the representative NDC, if present.
  • See the November 2024 Newsline article, Representative NDC on Electronic Prescriptions Do Not Infer Specificity for further details
• Instructions for Use
  • Ambiguous instructions should be clarified
  • Clarify when prescription appears to have two conflicting instructions
  • Check for “calculable” instructions; must be able to accurately calculate days’ supply based off instructions
  • Instructions, including clarifications, must be reflected accurately on the patient label prior to dispensing
• Days’ Supply
  • Auditors will generally not consider the days’ supply field on electronic prescriptions
  • Pharmacy must calculate days’ supply based on quantity and instructions for use
  • Use caution with a software’s default field for days’ supply as this information is frequently incorrect
  • Day’s supply must be billed accurately, bypassing days’ supply plan limits puts claims at risk of full recoupment
• DAW
  • Have documentation to support DAW codes billed other than “0”
  • Recommend confirming DAW 1 with prescriber when medication is new to patient
  • Check your state’s (and Medicaid’s) specific requirements for DAW 1 prescriptions
  • Brand name single source medications should not be billed with DAW 1 as this may increase audit risk
• Notes Field
  • Conflicting information in notes field should be clarified with the prescriber’s office
  • Be sure any additional instructions from the notes field are included on the patient label
• Failover Electronic Prescriptions
  • When electronic prescriptions fail to be transmitted, they may come through to the pharmacy’s fax machine
  • Confirm your state’s specific requirements for faxed prescriptions and call for verbal authorization, and document, when necessary
  • Explore techniques for spotting fraudulent electronic prescriptions in the July 2024 Newsline, How to Safeguard Your Pharmacy from Fraudulent Electronic Prescriptions