when entering the amount prescribed into a pharmacy management system, being careful not to change the amount prescribed to match the quantity being dispensed, unless authorized to do so. Auditors look at the overall quantity authorized by the prescriber, including refills. When the amount dispensed by the pharmacy over the life of the prescription exceeds this, that will result in “unauthorized refills” or “excessive quantity billed”.

Many states allow pharmacists to increase the dispensed quantity on a non-controlled prescription without contacting the prescriber for authorization (e.g., 1 month with 2 refills can be dispensed as 3 months with no refills). Pharmacy management systems also help track the total quantity prescribed to prevent pharmacies from these types of discrepancies, but they’re only as good as the data being inputted.

Pharmacies that dispense insulin pens in the unopened (sealed) carton (which PAAS recommends) can fall into the trap of over dispensing what the prescriber has approved. When a prescription is written for a quantity less than the smallest package size (i.e., 15 mL for insulin pen boxes), any increased amount must be authorized by the prescriber or be taken out of the total refill quantity (in states that allow accelerated/consolidated refills).

 Here is an example: Tresiba^® 100 unit/mL written for 6 mL with 2 refills

1. Pharmacy dispenses a full box (15 mL) to follow FDA guidelines
2. Prescription is refilled 2 additional times
3. Total amount prescribed is 6 mL x 3 = 18 mL
4. Total amount dispensed is 15 mL x 3 = 45 mL
5. Without a complete clinical note authorizing the increase in quantity to 45 mL, the pharmacy over dispensed by 27 mL

Insulin pens are not the only prescriptions to watch, other medications that are dispensed according to package size can also be at risk. See our Dispense in Original Container Chart for medications that may fall into this category.

PAAS Tips:

• Discuss how your pharmacy handles quantity changes with staff, so it is done consistently
• When contacting the prescriber about changing quantities or refills, be sure you document with a complete clinical notation. See our December 2023 Newsline article, Insufficient/Missing Clinical Notes Yield Audit Recoupments
• Be sure your transferred prescription refills are entered appropriately. See our June 2022 Newsline article, Best Practice for Entering Transfers with Partial Refills Remaining
• Self-audit claims by running reports for high-risk products to ensure they have been dispensed appropriately

an Authorized Generic of Zituvio^® and may be substituted at the pharmacy level without prescriber approval. Please note that pharmacies may not substitute sitagliptin for Januvia^®, nor can they substitute Zituvio^® for Januvia^® unless the prescriber approves, and this is documented with a clinical note.

Here is an excerpt from the FDA website explaining Authorized Generics:

“An authorized generic drug is the same as the brand-name drug but does not use the brand name on the label. In addition, an authorized generic version of a tablet or capsule may have a different color or marking. Because an authorized generic drug is marketed under the brand name drug’s New Drug Application (NDA), it is not listed in FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). An authorized generic is considered to be therapeutically equivalent to its brand-name drug because it is the same drug.”

Here is a comparison table to help pharmacies understand the differences, note the matching FDA application numbers of Zituvio^® and sitagliptin.

Product	Strengths Available	NDC	Manufacturer	FDA Application Number	Marketing Category
Januvia®	25 mg 50 mg 100 mg	00006-0221-xx 00006-0112-xx 00006-0277-xx	Merck Sharp & Dohme LLC	021995	NDA
Zituvio®	25 mg 50 mg 100 mg	70710-1240-03 70710-1241-03 70710-1242-03	Zydus Pharmaceuticals	211566	NDA
Sitagliptin	25 mg 50 mg 100 mg	70710-1899-xx 70710-1900-xx 70710-1901-xx	Zydus Pharmaceuticals	211566	NDA Authorized Generic

NDCs with “xx” have multiple pack sizes

PAAS Tips:

• Authorized generics are NOT separately listed in FDA Orange Book
• If you are ever in doubt about product substitution, call the PAAS team for assistance

• Standard Written Order (SWO)
• Signed and dated Certifying Physician Statement specifying the beneficiary meets all the following:
  • Certifying Physician is an M.D. (Medical Doctor) or D.O. (Doctor of Osteopathy)
  • Has diabetes
  • Has one of the following conditions:
    • Previous amputation of the other foot, or part of either foot, or
    • History of previous foot ulceration of either foot, or
    • History of pre-ulcerative calluses of either foot, or
    • Peripheral neuropathy with evidence of callus formation of either foot, or
    • Foot deformity of either foot, or
    • Poor circulation in either foot
  • Is being treated under a comprehensive plan of care for his/her diabetes, and needs diabetic shoes
  • The certification statement was signed on or after the date of the in-person visit and within 3 months prior to delivery of the shoes/inserts
• Medical Records
  • Evaluation was performed by the Certifying Physician, or entity meeting the “Incident to” requirements or a Nurse Practitioner (NP) enrolled in Primary Care First (PCF)
  • Evaluation was performed and/or reviewed by the Certifying Physician prior to completion of the Statement of Certifying Physician
  • Visit to document the qualifying foot condition occurred within 6 months prior to delivery
• Supplier Evaluation documenting that the beneficiary has one or more of the qualifying conditions listed above
  • An examination of the beneficiary’s feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications
  • Measurements of the beneficiary’s feet
  • For custom molded shoes and inserts, information regarding taking impressions, making casts, or obtaining CAD-CAM images of the beneficiary’s feet that will be used in creating positive models of the feet
• Supplier Assessment of Fit
  • Must occur at the time of in-person delivery
  • Supplier must conduct an objective assessment of the fit of the shoes and inserts while the beneficiary is wearing them and document the results
    • For Example: no slippage of heals when walking, ample toe room, feet are supported by heel counter, inserts make contact with patient’s feet and fit inside the shoe properly
  • A beneficiary’s subjective statement regarding the fit does not meet this criterion as they may have neuropathy which prevents them from feeling if there is any rubbing or pinching
• Proof of Delivery

PAAS Tips:

• A new Certification Statement is required for a shoe, insert or modification provided more than one year from the most recent Certification Statement on file
• A new order is not required for the replacement of an insert or modification within one year of the order on file. However, the supplier’s records should document the reason for the replacement
• A new order is required for the replacement of any shoe
• Review documentation checklist for Jurisdiction A and D
• Review documentation checklist for Jurisdiction B and C
• Review the Therapeutic Shoes for Person with Diabetes LCD
• Review the following Newsline articles for additional information:
  • August 2023, Standard Written Order and Medicare Part B Audit Risks – New Guidance

Search the Newsline archive for keyword “DMEPOS series” to read previous articles in this series. If you have any questions on accessing the Member Portal, or need help adding employees so they have access, please contact us and our staff can assist you.

1. Quantity
   1. NCPDP billing unit is mL, therefore the prescriber should be ordering the quantity as 3 mL, 6 mL, or 9 mL
   2. If ordered as a quantity of 1 kit or 1 unspecified, PBMs will mark the claim discrepant
2. Unit of Measure (UOM)
   1. If the UOM is missing, “unspecified,” or written for a UOM other than mL, it will lead to a discrepancy upon audit
3. Directions
   1. Prescribers should include how many mg are being used per week in the directions.
      1. Prescribers may erroneously write directions in mL vs mg
      2. Pharmacies may input directions incorrectly as mL vs mg
4. Prescribing
   1. Be sure the prescription is written for a strength that matches the dose being prescribed
      1. Example – prescription written for dosage that does not align with the product ordered
         1. Prescriber wrote for Ozempic^® 2 mg pen, but the directions indicate to use 1 mg weekly
   2. Prescribers often write for the 0.25 mg once weekly dosing with no titration. The recommended dosage of the manufacturer product label (section 2.2) states:
      • • Initiate Ozempic^® with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. The 0.25 mg dosage is intended for treatment initiation and is not effective for glycemic control.
        • After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
        • If additional glycemic control is needed after at least 4 weeks on the 0.5 mg dosage, the dosage may be increased to 1 mg once weekly.
        • If additional glycemic control is needed after at least 4 weeks on the 1 mg dosage, the dosage may be increased to 2 mg once weekly. The maximum recommended dosage is 2 mg once weekly.
5. Off-label use
   1. Ozempic^® is FDA approved for Type II diabetes (T2D). If prescribing for anything other than T2D, it could be considered off-label and flagged for recoupment by the PBM, especially for Medicare and Medicaid plans as they do not pay for off-label use and Medicare Part D, by law, does not cover weight loss drugs.

PAAS Tips:

• Review the following Newsline articles for additional information:
  • August 2023, Considerations With Ozempic 0.25 mg Weekly
  • May 2023, Ozempic Package Size Change
  • May 2023, Best Practices for Dispensing GLP-1 Medications and Reducing Recoupment Risk
  • September 2021, Electronic Prescriptions – Quantity Unit of Measure