• Only bill a claim pursuant to a valid prescription on file. Billing a “test” claim or “ghost” claim is prohibited by PBMs and those claims, even if reversed, are subject to audit.
  • Failure to provide a valid hardcopy can raise red flags and lead to accusations of billing false claims

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.

GLP-1 generic name	GLP-1 brand name	Approved indication(s)
Liraglutide	Victoza®	Type 2 diabetes in adults and children 10 years or olderType 2 diabetes in adults with known heart disease
	Saxenda®	Weight loss in adults and children 12 years or older
Dulaglutide	Trulicity®	Type 2 diabetes in adults and children 10 years or olderReduce cardiovascular events in adults with type 2 diabetes with established cardiovascular disease or multiple risk factors
Semaglutide	Ozempic®	Improve glucose in adults with type 2 diabetesReduce risk of cardiovascular events in adults with type 2 diabetes with known heart disease
	Wegovy®	Reduce risk of cardiovascular events in adults with type 2 diabetes with known heart disease AND either obesity or overweightAdults and children 12 and older with obesityOverweight adults who have weight-related medical problems
Tirzepatide	Mounjaro®	Adults with type 2 diabetes to improve blood sugar
	Zepbound®	Moderate-to-severe obstructive sleep apnea in adults with obesityObesity in adultsOverweight adults who have at least 1 weight-related comorbid condition

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

Remember that a future invoice audit from Caremark could cover purchases made between 02/01/2025 – 01/31/2026 which means that any purchases made during December 2024 will NOT be credited unless you provide notification to Caremark within 21 days after the purchase.

Section 8.05 of the Caremark Provider Manual outlines the requirement to provide notification of these bulk purchases for audit purposes – you must notify Caremark via mail or email as outlined below:

1. Pharmacy NCPDP
2. Contact email address
3. Drug name
4. NDC
5. Total quantity purchased
6. Name of wholesaler used

Email:   PharmacyAudit@CVSHealth.com

Mail:    

CVS Caremark
Attn: Bulk Purchase Notification, MC 020
9501 E. Shea Boulevard
Scottsdale, AZ 85260

Pharmacies do not need to include cost information when submitting. Some pharmacies have received a notification back stating that their purchase was “routine in nature” and would not be considered a bulk purchase, but PAAS would encourage pharmacies to continually inundated/notify Caremark and document these responses as they could become relevant (and useful) in an audit situation.

PAAS Tips:

• PAAS National^®® recommends keeping record of both your submission and any responses received from Caremark in the event of a future audit.
• Watch the June 15, 2022 on-demand webinar Caremark’s Bulk Purchasing Requirements for more background information