The first step is to make note of any reject messages received when processing for the correct days’ supply. For example, if the insurance limits the quantity to a 30 days’ supply, write “ILQ 30” on the prescription. Then reduce the quantity, if possible, and rebill the claim with the adjusted [accurate] days’ supply based on the revised quantity. Reduce the quantity further if the claim still rejects, until you reach the smallest unbreakable package size.

If the smallest unbreakable package size still does not go through with an accurate day’s supply:

1. PBMs may provide claim reject messaging to prompt submission of “SCC 10” to allow the true day supply for accurate refill intervals, reimbursement and copays. Document use of this on the prescription.
2. Call the PBM helpdesk and request an override – document on the prescription if approved or denied.
3. If no smaller package size exists and PBM can’t (or won’t) issue an override, most PBMs will allow the smallest package to be billed for the maximum days’ supply identified in the original reject message.

If the above process is used, and you processed the claim with an adjusted [inaccurate] days’ supply, you are at risk for early refills because the PBM adjudication logic will allow you to submit a refill claim when the utilization threshold is met based on the previous days’ supply adjudicated, not the actual days’ supply. PBMs still require the pharmacy to monitor utilization and only refill when appropriate based off the accurate [calculated] days’ supply and not the adjudicated days’ supply. Remember, the claim rejection for “refill too soon” will not be appropriately triggered when the pharmacy is forced to bill a smaller days’ supply than the true calculated day’s supply. To help avoid this, PAAS National^® suggests documenting the actual days’ supply in the directions for use (e.g., “actual days’ supply=37”) so that it prints on the label to alert staff and patients of the appropriate refill intervals.

Another situation pharmacies run into is when the accurate days’ supply is rejected due to exceeding the plan limit for a maximum daily dose.

For example, a prescription written for OxyContin^® 30 mg, quantity 90, with directions to “take one tablet 3x daily” may receive a rejection for “Maximum two tablets per day.”

In this situation, pharmacies should not reduce the quantity to 60 tablets for a 30-day supply (this would be considered bypassing the plan limit). Instead, pharmacies should pay close attention to any messages given on how to resolve the rejection, including calling the PBM help desk for an override or getting a prior authorization started with the prescriber. Alternatively, the prescriber could decide to change the dose or prescribe an alternative medication.

What if the prescriber refuses to obtain a prior authorization or change the prescription to a clinically appropriate dose? Can the claim be split-billed? PAAS National^® highly recommends against split billing or processing a claim as cash to circumvent a plan limit or prior authorization requirement. A doctor who refuses to obtain a prior authorization or change the medication/dose could be a red flag for diversion with controlled substances. Most plan limits are put in place based on appropriate clinical use and bypassing them can lead to easy recoupments for PBMs. Pharmacists have a corresponding responsibility to ensure that prescriptions are for legitimate medical purposes, especially for controlled substances.

PAAS Tips:

• Always bill an accurate days’ supply based on the directions first; many PBMS have overrides in place for the smallest package sizes
• Only follow the ILQ process above if you are dispensing the smallest unbreakable package size
• Billing a 30-day supply on two boxes of insulin that should last 50 days is not appropriate. Instead, you must resubmit one box for 25 days if the plan limit is 30 days
• Include a notation on the patient label to help notify patients and pharmacy staff of the true days’ supply
• Check with your software vendor to see if additional days’ supply fields are available for internal tracking
• Avoid med sync or cycle fill programs for products whose correct days’ supply cannot be submitted for the smallest single package size
• Educate all pharmacy staff to identify rejection messages and how to properly resolve them
• Any DUR verifications, especially if using “M0” (prescriber consulted) to override the DUR, should have supporting documentation on the prescription or within retrievable electronic records
• Do not split bill rejected claims
• Charging the patient cash often leads to complaints [from the patient to an employer or PBM] and can be considered non-compliance with the provider manual and lead to remediation, including potential network termination
• If you have exhausted all plan options (including pursuing PAs and/or alternative therapies) and the patient insists on paying cash for the full prescription, be sure that you document authorization from the patient that they desire to pay the full cost and will not seek reimbursement from the insurance.
•  Review our Can You Bill It As 30 Days? document under Proactive Tips on the Member Portal

After the days’ supply has been adjusted, some of the subsequent [refilled] claims may be flagged as early refills – which result in a full chargeback. Now, if the interval between two fill dates is appropriate (i.e., not refilled early – typically 75% utilization of an accurate days’ supply for OptumRx^®), OptumRx^® will still look to chargeback any additional copay(s) that would have been incurred when the correct days’ supply was submitted (up to the plan limit for the actual days’ supply).

Here is an example where the patient has a $40 copay per 30 days billed:

Prescription is written for Symbicort^® 80 mcg retail package size of 10.2 grams with directions of 1 puff twice a day. Symbicort^® 80 mcg contains 120 puffs and therefore the calculated days’ supply would be 60. If the pharmacy accidently billed for a 30 days’ supply instead of 60 and the Symbicort^® was refilled monthly, OptumRx^® will flag every other fill as a refill too soon (2Z) and chargeback the full amount. On the dates of service flagged as invalid days’ supply only (1N), OptumRx^® will chargeback an additional copay that would have incurred had the pharmacy billed the claim correctly (assuming the plan didn’t limit the days’ supply to 30).

Fill date	Days’ supply Pharmacy billed	OptumRx® adjusts to correct days’ supply	Discrepancy Code *	Chargeback
02/07/2024	30	60	1N	$40.00 (copay)
03/05/2024	30	60	2Z, 1N	$235.29
04/08/2024	30	60	1N	$40.00 (copay)
05/17/2024	30	60	2Z, 1N	$235.29

*1N – invalid days’ supply

*2Z – refill too soon

PAAS Tips:

• Insulin, inhalers, topical medications, and eye drops are frequently flagged for refill too soon or overbilled quantity
• Always submit claims with an accurate days’ supply first; many PBMs now have built-in overrides in place for smallest package sizes
• If plan limit is 30 days, then follow PAAS’ Can You Bill It As 30 Days?  
• Include a notation on the patient label to help notify the patient and pharmacy staff of the true days’ supply
• Check with your software vendor to see if additional days’ supply fields are available for internal tracking
• Avoid med sync or cycle fill programs for products whose correct days’ supply cannot be submitted for the smallest single package size
• The updated Audit Violation and Discrepancy Description for 1N can be found in the OptumRx Provider Manual on page 147
• Be proactive and utilize the PAAS Rx Days’ Supply Calculator. Download the app for a free 7-day trial ($5.99/year thereafter) by visiting the Apple App Store or Android Google Play Store, or check out the website at PAASNational.com/app
• Read more on What to Do (and Not Do) When Your Days’ Supply is Rejected in this month’s Newsline article

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.