Miebo™ Eye Drops – What is the Days’ Supply?

Miebo™ is the first and only prescription eye drop used to treat dry eye syndrome by directly targeting tear evaporation. PAAS National® has fielded several calls regarding Miebo™ asking how to calculate the days’ supply. Per DailyMed, Miebo™ comes in a package size of 3 mL. Section 16 of the package insert states it is supplied in a multi-dose 5 mL bottle. Which measurement, 3 mL, or 5 mL, should you use to calculate the days’ supply? Miebo™ is billed as 3 mL; there are 3 mL of active ingredient in a 5 mL multi-dose bottle, presumptively to make administration easier. However, based on information from the Bausch + Lomb website, the days’ supply calculation remains complicated. Miebo™ contains only one ingredient (perfluorohexyloctane), unlike other eye drops that contain water, preservatives, and steroids. Eye drop formulations with water have a typical drop size of 30 to 50 microliters. The Miebo™ drop size is much smaller at 11 microliters, causing problems with the traditional 15 to 20 drops per mL estimate.

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Per the manufacturer, the preservative free multi-dose 3 mL bottle should give the patient a one-month supply with the normal dosing of 1 drop , in both eyes, four times a day. Approximating based on a drop size that is 1/3 -1/5 smaller, the patient should get 3 to 5 times more drops. That would be anywhere from 135 – 300 total drops, with 240 drops being required for a 30-days’ supply.

PAAS Tips:

2024 Self-Audit Series #1: Insulin Prescriptions

Starting this month, we will be refreshing our Self-Audit Series with new and updated information. Each month will focus on different prescription types and provide pharmacies with information PAAS National® analysts are currently seeing on PBM audits. These articles can be an excellent training tool for new employees, and a great refresher for all pharmacy staff, to avoid audit discrepancies.

PAAS Tips: 

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  • Dosage Form/Strength/Substitution
    • Prescription should clearly indicate vials or pens – this should not be assumed.
    • Concentration of the insulin should be clearly stated if more than one exists (e.g., U-100 vs U-500).
    • See the February 2024 Newsline, Insulin Substitution Review: Understanding Purple Book Terminology
    • Consider the pen device administrable dosing increments (0.5, 1, 2 or 5-unit increments)
    • Quantity
      • Pharmacies should never assume they know what the prescriber intended for quantity; if unclear, be sure to clarify and document appropriately.
        • Quantity of “one” is not sufficient for audit purposes and requires clarification.
      • Unit-of-measure for the quantity prescribed must identify mL, pens, boxes, or units.
      • Auditors will look at the overall quantity prescribed, so increasing to dispense a full box of pens must be authorized by the prescriber and documented, or additional quantity taken out of the refills authorized, where allowed by state law.
        • If the prescription is for 9 mL with 2 refills (and your state allows you to accelerate refills), the pharmacy can still only dispense one 15 mL box without calling the prescriber for additional authorization.
      • Instructions for Use
        • Incomplete or unclear instructions should be clarified and documented prior to dispensing.
        • Sliding scales or titration prescriptions must include a max daily dose the patient can use.
        • Patient label must match prescription instructions, including max daily dose if clarified.
      • Days’ Supply
        • Calculate days’ supply based off the directions on the prescription.
        • Follow instructions on our Can You Bill It As 30 Days? guideline if days’ supply for smallest package size (1 box for pens) exceeds plan limit.
        • Do not assume the days’ supply indicated on electronic prescriptions is correct, this field will not be taken into consideration by auditors.
        • Priming units for insulin pens are typically 2 units per injection; however, some pens require different priming units. Document priming units if used in days’ supply calculation.
        • Be mindful of expiration dates for vials and pens – days’ supply should not exceed this date.
        • Do not bypass plan limits by altering the days’ supply to get a paid claim. Follow the plan guidance and obtain a prior authorization if necessary.
      • Route of Administration
        • Insulin pens should always be self-administered.
        • Rapid-acting insulin vials may be used for injection or in an insulin pump.
  • Resource for Insulin Pens and Vials
    • PAAS National® provides members with a practical Insulin Medication Chart
      • This chart includes package size and dosage form, units/mL, total units per package and beyond use dates for pens and vials.

Continuous Glucose Monitor (CGM) Billing and Supply Allowance

CMS has issued an update on the Glucose Monitor – Policy Article effective as of January 1, 2024. A supplier now has the option to bill and dispense up to a 90-day supply for procedure codes A4238 (Adjunctive CGM) and A4239 (Non-Adjunctive CGM).

The policy article states:

“Up to a maximum of three (3) months, ninety (90) days of the supply allowance may be billed for code A4238 or A4239 to the DME MAC at a time and suppliers may not dispense more than a ninety (90) day supply.”

Below is a helpful chart to categorize the Dexcom and FreeStyle CGM products, their respective NCPDP billing units, and corresponding days’ supply.

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Product NDC NCPDP Billing Unit Day’s Supply
Dexcom G6 Receiver 08627-0091-11 1 Each Once a year
Dexcom G6 Transmitter 08627-0016-01 1 Each Every 3 months
Dexcom G6 Sensor 08627-0053-03 3 Each Every 30 days
Dexcom G7 Receiver 08627-0078-01 1 Each Once a year
Dexcom G7 Sensor 08627-0077-01 1 Each Every 10 days
FreeStyle Libre 14-day Sensor 57599-0001-01 1 Each Every 14 days
FreeStyle Libre 14-day Reader 57599-0002-00 1 Each Every 3 years
FreeStyle Libre Reader 57599-0000-21 1 Each Every 3 years

PAAS Tips:

  • When billing Medicare Part B claims for procedure codes A4238 or A4239, claims are billed as 1 unit of service (UOS) per 30 days
  • The NCPDP billing units shown in the chart above would apply to non-Medicare Part B claims
  • A CGM supply allowance includes all items necessary for the use of the device and includes, but is not limited to, CGM sensors and transmitters
    • For adjunctive CGMs , the supply allowance code (A4238), does not include supplies for a Blood Glucose Monitor (BGM.). Any required BGM supplies must be billed separately
    • For non-adjunctive CGMs, the supply allowance code (A4239), also includes a home BGM and related supplies in the bundled payment (test strips, lancets, lancing device, calibration solution, and batteries)
    • See our April 2022 Newsline, Billing Blood Glucose Test Strips for a Patient Who Utilizes a Continuous Glucose Monitor for the definitions of Adjunctive and Non-Adjunctive CGMs
  • The supplier must monitor usage and verify the beneficiary has sufficient supplies to last for each 30-day billing period
  • Utilize the CGM Supply Allowance Billing Calculator found on your DME MAC website to help determine when the next date of service can be billed
    • CGS
    • Noridian
  • Check the same/similar tool in myCGS for a complete claim history to be sure the patient has not received supplies from another supplier in the last 30 or 90 days
  • If the patient requires a replacement sensor, transmitter, or receiver due to a product failure, be sure to document and replace the item while reaching out to the manufacturer
  • Beware that any PBM, including Medicare B, will recoup or deny a claim if it is refilled too soon based on days’ supply guidelines above

Be on the Lookout for Eye Drops Requiring Extra Billing Consideration

Correctly billing eye drops requires a little extra thought and consideration, but it does not have to be a daunting task. Follow these simple steps and remember to be on the lookout for the unique eye drops listed below.

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  1. Ensure the prescription has calculable directions including which eye, or eyes, the drops are being utilized in, the frequency for which they are used, and a specified quantity (e.g., mL, bottles, vials)
  2. Calculate the days’ supply using PBM published guidelines regarding appropriate drops per milliliter; refer to the PAAS Eye Drop Guidance tool on the Member Portal for a listing of eight top PBMs and their required drops/mL
  • If a PBM does not provide published guidance, use 20 drops/mL for solutions and 15 drops/mL for suspensions and emulsions
  1. Adjust the days’ supply billed, when necessary, to account for manufacturer product labeling such as manufacturer beyond use dating (available at U.S. National Library of Medicine DailyMed website)
Medication Available Package Sizes Manufacturer Beyond Use Date
AzaSite® 1% solution 2.5 mL 14 days
Rhopressa® 0.02% solution 2.5 mL 42 days
VyzultaTM 0.024% solution 2.5 mL, 5 mL 56 days
Xalatan® 0.005% solution 2.5 mL 42 days
  1. Ensure drops available in single-use vials are calculated based on the number of vials needed per day, not drops/mL
Medication NDC Package Size Special Considerations
Restasis® 0.05% emulsion 00023-9163-30

00023-9163-60

 Carton of 30 vials

Carton of 60 vials

 The emulsion from one single-use vial is to be used immediately after opening for administration to one or both eyes; the remaining contents should be discarded immediately

Caution: Restasis® is also available in a 5.5 mL multi-dose preservative-free bottle NDC 00023-5301-05
Xiidra® 5% solution 00078-0911-12 Carton of 60 vials The solution from one single-use container is to be used immediately after opening and can be used to dose both eyes; the remaining contents should be discarded immediately
Zioptan® 0.0015% solution 82584-0609-30 Carton of 30 vials The solution from one individual vial is to be used immediately after opening for administration to one or both eyes; the remaining contents should be discarded immediately

PAAS Tips:

  • Prescriptions written for “1 bottle” are handled differently from one PBM to the next
    • Auditors will often use a vague quantity (or directions, drug formulation, etc.) to their advantage and flag the claim for recoupment
    • Avoid time-consuming appeal procedures across all PBMs by contacting the prescriber’s office and clarifying vague or ambiguous information prior to billing (i.e., quantity from “1 bottle” to number of milliliters)
  • If the treatment duration (e.g., “use for 10 days”) is less than the calculated days’ supply, submit the true calculated days’ supply
  • If discard instructions (e.g., “discard after 10 days”) are included on the prescription and it is a smaller days’ supply than the calculate days’ supply, submit the claim with a days’ supply matching the treatment duration
  • Refer to the March 2024 Newsline regarding special billing considerations for MieboTM ophthalmic solution

2024 DMEPOS Series #1: Diabetic Test Strips

Many pharmacies struggle with DMEPOS audits due to the complexity in medical billing and the onerous documentation requirements. Medicare Part B suppliers need to be able to produce all the required documentation if audited and make sure all documentation meets Medicare Part B standards. This DMEPOS series is intended to help you understand these complexities and gather the needed documents.

In particular, you should be able to show the following if audited on diabetic test strips:

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Standard Written Order (SWO):

  • Beneficiaries name OR Medicare Beneficiary Identifier (MBI)
  • The order date – this cannot be stamped
  • A detailed description of the items ordered
  • The quantity to be dispensed
  • Treating practitioner’s name OR NPI
  • Treating practitioner’s signature – this cannot be stamped

Dispensing/Proof of Delivery:

  • Beneficiary name
  • Delivery address
  • Detailed description of the item(s)
  • Quantity delivered
  • Date delivered – must match the date of service billed
  • Signature of beneficiary or representative

Delivery/Mailing:

  • When delivering or mailing test strips to Medicare beneficiaries, the pharmacy must have a proof of refill request (PORR) and affirmative response from the beneficiary or their representative including, at minimum:
  • Requestor’s name (beneficiary or authorized representative)
  • A description of each item being requested
  • Documentation of an affirmative response indicating a need for the refill
  • Includes confirmation that the beneficiary is still using the item
  • No changes have been made to the order
  • A refill is needed
  • Date of the request
  • DMEPOS items and supplies that are provided on a recurring basis must be based on prospective, not retrospective, use
  • Contact with the beneficiary, or authorized representative, must take place no sooner than 30 calendar days before the expected end of the current supply

Medical Records:

  • A covered diagnosis
  • Testing frequency (including rationale and testing logs if the patient is exceeding Medicare guidelines)
  • Continued need and use
  • Signed by the treating practitioner

Billing:

  • Bill the “Medicare/Medicaid” version of strips, when available
  • Verify the NDC being billed is for the correct package size
  • Attach the correct modifier – whether the patient is on insulin (KX) or not on insulin (KS)

PAAS Tips:

  • While refills are not a required element on the SWO, if the practitioner writes for refills, they will be honored exactly as specified regardless of the total quantity written.
  • If an order is for a 90-day supply with three refills (or 360 total days), and the patient requests a 30-day supply at a time, Medicare will only allow for the three additional fills.
    • Consider asking the prescriber to resend the SWO written for 30 days’ supply at a time plus an adjusted number of refills to avoid unauthorized refills.
  • Any corrections to an SWO must be signed and dated by the prescriber prior to submitting a claim.
  • If you call the prescriber’s office for a clarification to the order and document the clarification with a clinical note (e.g., MD clarified #30 with 11 refills is ok), that note should be counter-signed by the prescriber to validate the change. (This is not standard practice for non-DMEPOS claims, but DME MACs are enforcing this for Medicare Part B billing.)
  • Alternatively, ask the prescriber to send a new SWO with the additional information.
  • For an item that the beneficiary obtains in-person at your pharmacy, the signed delivery slip or copy of an itemized sales receipt is sufficient documentation for a refill request and affirmative response.
  • The supplier must provide the DMEPOS product no sooner than 10 calendar days before the expected end of the current supply – regardless of whether the refill is picked up in the pharmacy or delivered.
  • While obtain medical records prior to billing is rarely pragmatic, it is prudent to consider when patients are exceeding guidelines for testing (as prescribers may be unaware of requirements and subsequent Medical Records may be lacking sufficient detail for payment).
  • If you have reason to believe the strips will not be covered by Medicare, consider obtaining a signed Advance Beneficiary Notice (ABN) of Non-coverage prior to dispensing.
  • Allows the transfer of financial liability back to the patient in the event the claim is denied.
  • ABN must be completely and appropriately filled out and specify the reason Medicare may deny the claim.
  • ABN must be completed and signed on or prior to the date of service.
  • Use all the tools and resources available on your local DME MAC website to ensure you are compliant with Medicare’s billing and documentation rules.

Dosing Increments for Insulin Pens

While insulin pens allow ease and convenience for diabetic patients, they also come with increased audit risks, for a variety of reasons, including dosing.

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Prescribers are often unaware of what each insulin pen is capable of dispensing. Pharmacies must be hypervigilant of possible instructions that the insulin pen would not be able to deliver. Clinically, the patient would not be able to receive the prescribed number of units, and an audit discrepancy could be flagged. Appealing these types of discrepancies can often be very difficult.

While most insulin pens can be dialed in 1-unit increments, this is not the case for all pens. There are strengths of insulin pens that can only be dialed in 0.5-unit, 2-unit and 5-unit increments. Prior to dispensing these exceptions, the pharmacy must ensure the instructions for use are administrable with the pen prescribed. If the directions don’t coincide with the dosing increments (e.g., 57 units of Tuojeo® Max Solostar®), contact the prescriber for a correction.

Insulin Dosing Increments
Humalog® Junior KwikPen® 0.5 units
Toujeo® Max Solostar® 2 units
Tresiba® Flextouch® 200units/mL 2 units
Humulin® R U-500 KwikPen® 5 units

PAAS Tips:

  • Educate all pharmacy staff on the different insulin pens and their dosing ability
  • Contact prescribers if dosing or strength must be adjusted and add a clinical notation
    • Clinical notes should contain the date/time, person to whom the call was made (and their title), a brief summary of the discussion, and the pharmacy employee’s name/initials
    • Ensure the patient label is updated, and patients are counseled, accordingly
  • Be sure to utilize our Insulin Medication Days’ Supply Chart, available on the PAAS Member Portal, for additional insulin information

Employer Pays $4.75 Million after Employee Stole, then Sold, Protected Health Information

While HIPAA training may feel tedious and appear to be a waste of time and payroll, it’s crucial not to take shortcuts when it comes to compliance!

First, HIPAA Privacy and Security Rules were created to protect sensitive patient information and improve the quality of care patients receive. Patients should feel comfortable sharing their most private health information with healthcare providers during their examinations and treatments. If patients fear their information will not remain confidential, they are less likely to be transparent, potentially impacting the care they receive.

Second, as a Covered Entity under HIPAA, the pharmacy is responsibility to ensure staff are adequately trained and appropriate safeguards are in place to secure protected health information (PHI). Look no further than the February 6, 2024 press release from the U.S. Department of Health and Human Services Office for Civil Rights (OCR) to see how expensive brushing off your obligations to the HIPAA Security Rule can be. According to the release, Montefiore Medical Center settled with OCR for a jaw dropping sum of $4.75 million dollars for several potential violations of the HIPAA Security Rule. As outlined in the release, an employee stole the electronic PHI of 12,517 patients and sold that information to an identity theft ring. The police notified Montefiore Medical Center of the situation after they had “evidence of theft of a specific patient’s medical information”. Only after the police notified Montefiore, two years after the employee stole the data, did the Medical Center perform an internal investigation and find the breach.

During the OCR’s investigation, they found “multiple potential violations of the HIPAA Security Rule, including failures by Montefiore Medical Center to analyze and identify potential risks and vulnerabilities to protected health information, to monitor and safeguard its heath information systems’ activity, and to implement policies and procedures that record and examine activity in information systems containing or using protected health information. Without these safeguards in place, Montefiore Medical Center was unable to prevent the cyberattack or even detect the attack had happened until years later.”

Lastly, learn from Montefiore Medical Center mistakes and follow these PAAS Tips:

  • Prioritize having a comprehensive HIPAA training program
    • In place for all employees involved in the handling of PHI
    • Ensures HIPAA Rules are equally enforced across all levels of staff
    • Employees understand the importance of taking their training seriously.
    • HIPAA training should include information about civil, monetary, and criminal penalties for violations of the HIPAA Rules to reinforce the importance of compliance.
  • Review and update, no less then annually, your HIPAA Risk Analysis to ensure you have the proper safeguards in place. This is a required HIPAA form and must be retained for six years.
  • Ensure there are adequate safeguards in place to prevent and detect malicious behavior; for more information review the following Newsline articles:

If you are not sure where to start, contact PAAS National®® (608) 873-1342 for more information on PAAS’ FWA/HIPAA Compliance Program that is easy to set-up, web based and customized for your pharmacy.

Additional Audit Assistance Member Benefits

As we start 2024, keep in mind your Audit Assistance membership includes more than just assistance on audits and a monthly printed newsletter. Members have access to additional Newsline content online in the Member Portal, in addition to an archive of articles.

Plus, as a member benefit you have access to additional audit tactics and prevention tips:

PAAS Audit Assistance Administrators can keep their employees engaged and lower audit risk by adding employees to the Portal so the entire staff can access these resources and the eNewsline.

If you have any questions on accessing the Member Portal or need help adding employees, please contact us at (608) 873-1342 or info@paasnational.com and our staff can assist you.

Insulin Substitution Review: Understanding Purple Book Terminology

PAAS National® frequently gets questions about whether pharmacies may substitute various medications and if such substitutions require the approval of the prescriber. For biological products, pharmacies can refer to the FDA Purple Book to identify biosimilarity and interchangeability.

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Pharmacy level substitution of a reference product is only allowed if biologic drugs are either identified as (i) an interchangeable biosimilar OR (ii) an unbranded biologic with the same BLA number of a reference product. Importantly, unbranded biologics are NOT separately listed in the Purple Book as explained by FDA here (see FAQ #11). For biologic drugs that don’t fall into these two categories, you must obtain prescriber approval prior to substituting.

Additionally, pharmacy level substitution is regulated at the state level. If you’re unsure of your requirements, Cardinal Health has a great website to find biosimilar interchangeability laws for each state.

It is also important to understand the terminology used in the Purple Book as biologic products are not described in familiar terms like “brand”, “generic” or “AB-rated” that most pharmacy staff have been trained on. Here is a short summary of the different terms:

  1. Reference product is a single biological product approved under a 351(a) BLA.

Think of these products like brand drugs in the FDA Orange Book – they cannot be substituted for other brand drugs without prescriber approval.

  1. Biosimilar products are approved through an abbreviated BLA pathway under a 351(k) biosimilar

Think of these products like B-rated generic drugs in the FDA Orange Book – they cannot be substituted for brand drugs without prescriber approval.

  1. Interchangeable biological products are biosimilar products that have been deemed interchangeable with a reference product after going through additional switching studies and are approved under a 351(k) interchangeable 

Think of these products like A-rated generic drugs in the FDA Orange Book – they CAN be substituted for brand drugs without prescriber approval (where allowed by state law).

  1. Unbranded biologic products are NOT listed in the Purple Book but are approved under the reference product’s 351(a)

Think of these products like authorized generic drugs in the FDA Orange Book – they CAN be substituted for brand drugs without prescriber approval.

Here are some insulin examples to help understand the relationship between various products that have a similar proper name and when pharmacies can (or cannot) substitute without prescriber approval (where allowed by state law).

Insulin Glargine

Proprietary Name Proper Name BLA Number Labeler BLA Type RPh Substitute*
Lantus® Insulin glargine 021081 Sanofi 351(a) Reference product Yes
Insulin glargine Insulin glargine 021081 Winthrop Unbranded biologic Yes
Semglee® Insulin glargine-yfgn 761201 Biocon 351(k) Interchangeable Yes
Insulin glargine-yfgn Insulin glargine-yfgn 761201 Biocon Unbranded biologic Yes
RezvoglarTM Insulin glargine-aglr 761215 Eli Lilly 351(k) Interchangeable Yes
Basaglar® Insulin glargine 205692 Eli Lilly 351(a) Reference product No

*Where allowed by state law

Insulin Lispro

Proprietary Name Proper Name BLA Number Labeler BLA Type RPh Substitute*
Humalog® Insulin lispro 020563 Eli Lilly 351(a) Reference product Yes
Insulin lispro Insulin lispro 020563 Eli Lilly Unbranded biologic Yes
Admelog® Insulin lispro 209196 Sanofi 351(a) Reference product No
LyumjevTM Insulin lispro-aabc 761109 Eli Lilly 351(a) Reference product No

*Where allowed by state law

Insulin Aspart

Proprietary Name Proper Name BLA Number Labeler BLA Type RPh Substitute*
NovoLog® Insulin aspart 020986 Novo 351(a) Reference product Yes
Insulin aspart Insulin aspart 020986 Novo Unbranded biologic Yes
Fiasp® Insulin aspart 208751 Novo 351(a) Reference product No

*Where allowed by state law

PAAS Tips:

Inventory Purchase Reminders for Successful Audits

With a 29% increase in PBM audits in 2023, PAAS National® wants to help you avoid PBM scrutiny, especially when it comes to drug procurement.

PBMs conduct invoice audits to confirm pharmacies have purchased enough medication to support the claims they have billed for. This is the primary method PBMs can identify false/phantom claims, where a pharmacy is billing for medications that never get dispensed. The auditor will reconcile claims billed with invoices provided, over a certain timeframe. After the reconciliation is complete, any inventory shortages must be explained or resolved by the pharmacy, or it could result in recoupment of claims and even termination of contract if there are substantial issues.

PAAS analysts have assisted with countless invoice audits and are eager to provide helpful tips for success.

PAAS Tips:

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  • Take the proper steps to vet any wholesaler you intend to purchase from
    • Confirm they are licensed in your state
    • Check the NABP website for Accredited Drug Distributors (formerly “VAWD”)
    • Verify you have a direct contact to request invoices on a timely manner
    • Be sure wholesaler can provide Drug Supply Chain Security Act (DSCSA) information if requested
  • Diabetic test strips have unique requirements
    • OptumRx requires OTCs dispensed via prescription to be bought from a licensed wholesaler accredited by NABP
    • Caremark and Express Scripts require Authorized Distributors of the manufacturer
      • If the pricing is substantially better, they’re likely not authorized – even if they’re affiliated with one that is (i.e. McKesson-authorized; River City Pharma & Masters-not authorized)
    • Authorized Distributors can be verified at the links below
      • Abbott https://www.diabetescare.abbott/support/distributors.html
      • Ascensia https://www.ascensiadiabetes.com/ (click on “distributors” at the bottom of the page)
      • LifeScan genuineonetouch.com
      • Roche https://rxvp.accu-chek.com/welcome/adr_list
      • Trividia Health https://www.trividiahealth.com/where-to-buy/
    • Limit pharmacy to pharmacy purchases to a minimum
    • Be sure the NDC billed is the NDC dispensed, this includes package size
      • Bar code scanning is highly recommended during the filling process
    • Remember Caremark requires pharmacies to notify them of any bulk purchases
    • Verify your pharmacy is appropriately reversing claims that are not dispensed

Need assistance with an invoice audit? Engage PAAS early for information and guidance for the best possible outcome. Call (608) 873-1342 or email to info@paasnational.com