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Protecting Your Pharmacy from ​Fraudulent Electronic Prescriptions

Preventing Electronic Prescription Fraud

Recently, PAAS National has assisted pharmacies in ​dealing with fraudulent electronic prescriptions ​stemming from compromised prescriber credentials. ​Earlier this year, a significant e-prescription fraud ​incident saw criminals issuing over 18,000 fake ​prescriptions to pharmacies across 18 states within ​just five hours.

Financial Repercussions and Mitigation

Fraudulent prescriptions billed to insurance can lead ​to full recoupment during PBM audits. Pharmacies ​must cooperate with PBM audits and demonstrate ​their “due diligence” in verifying prescriptions to avoid ​being considered willing participants. To mitigate ​financial losses from PBM recoupments, pharmacies ​may need to rely on business insurance or pursue ​legal action against the fraudsters.

Proactive Measures for Prevention

While electronic prescriptions are generally safer than ​their written or telephone counterparts, they are not ​immune to criminal exploitation. Here are some ​strategies to identify fraudulent electronic ​prescriptions at your pharmacy:

1. Familiarize Yourself with the Prescriber

  • Is the prescriber new to your area?
  • Have you previously received prescriptions from ​this prescriber?
  • Is the prescribed medication within their scope ​of practice?
  • Can you verify the prescriber’s details (e.g., ​phone number, address) through public ​resources?

2. Know Your Patient

  • Is the patient new to your pharmacy?
  • Does the patient reside within your service ​area?
  • How was the prescription insurance information ​obtained?
  • Consider requiring a photo ID for prescriptions ​picked up by new patients.
  • Be cautious if all interactions are through a ​friend or family member.

3. Scrutinize the Prescription for Anomalies

  • Is the dosage regimen unusual?
  • Does the patient have a valid reason for using ​the medication?
  • Does the patient have other prescriptions from ​this prescriber? Can the patient confirm ​treatment by this prescriber?
  • Are there multiple prescriptions for high-cost ​brand medications, especially those dispensed ​in their original containers?

By implementing these measures, you can better ​safeguard your pharmacy against fraudulent electronic ​prescriptions and avoid the associated financial and ​legal repercussions.

MGMT Tips:

  • Reversing and “cashing out” discount card ​Record your due diligence efforts either on the ​prescription itself or within your pharmacy ​management software.
  • Report fraudulent prescriptions to the prescriber, ​local law enforcement, the board of ​pharmacy/medicine, and the PBM.
  • Reach out to your business insurance provider, ​as they might offer solutions to help manage ​fraud-related losses.

New Dispense as Written (DAW) Code Introduced

You’re likely familiar with DAW codes 1, 2, or 9. ​Pharmacy staff generally know that DAW 1 is used ​when the prescriber prohibits generic substitution for a ​multi-source brand, DAW 2 when the patient requests ​the brand name, and DAW 9 when the insurance plan ​prefers the brand name product. These rules also ​apply to biologic reference products, such as Lantus, ​with interchangeable biosimilars like Semglee.

However, real-world claim adjudication can be more ​complex. For example, a patient with both a ​commercial primary insurance and Medicaid as ​secondary might face conflicting preferences, with ​one payor favoring the brand and the other the ​generic.

To address such scenarios, the National Council for ​Prescription Drug Programs (NCPDP) has introduced its ​first non-numeric DAW code. The new alpha code, ​DAW A, is included in the NCPDP Telecommunication ​Version D and

Above Questions, Answers, and Editorial Updates ​(Version 65, May 2024). DAW A is used for multi-payor ​claims, indicating to one payor that another payor ​requires the multi-source brand or reference product ​(with an interchangeable biosimilar) to be dispensed.

For claims:

  • Use DAW 9 for the payor requiring the multi-source ​brand/reference product, regardless of whether it’s ​the primary or secondary payor.
  • Use DAW A for the other payor that does not ​require the multi-source brand/reference product, ​again regardless of its status as primary or ​secondary.

Using the DAW A code allows the payor that does not ​require the multi-source brand/reference product to ​either accept the claim with the associated brand ​pricing rules or reject it as 70: Product/Service Not ​Covered – Plan/Benefit Exclusion.

MGMT Tips:

Documentation: Ensure there is appropriate documentation on the hardcopy or within the prescription record to ​indicate which plan required the brand and which did not for any DAW code other than 0.

Common Scenario: When Medicaid is the secondary payor and requires the brand/reference product, but the ​primary payor does not, follow these steps:

  • Submit the claim for the generic drug using DAW 0 to the primary payor for a paid claim with a non-$0 patient ​copay.
  • Continue billing and submit the claim for the generic drug using DAW 0 to Medicaid (secondary).
  • Medicaid will reject the claim as 606-Brand Drug/Specific Labeler Code Required.
  • Reverse the claim and resubmit the multi-source brand/reference product to the primary payor with DAW 9. They ​should reject with 22: M/I DAW Code, and if the pharmacy continues and bills to Medicaid (secondary), Medicaid ​may reject the claim as 6E: M/I Other Payor Reject Code.
  • Bill the claim to the primary payor for the multi-source brand/reference product with DAW A (Multi-Payor ​Brand/Reference Product Formulary Conflict). The primary payor should accept the claim and apply brand ​pricing.
  • Continue to bill the multi-source brand/reference product to Medicaid as the secondary payor with DAW 9.

Auditors Are Attracted to Santyl® Like Insects to Light

As summer arrives, so do the bugs! ​Though mosquitos, gnats, and moths ​have little to do with Santyl® ointment, ​used for debriding chronic dermal ​ulcers and severe burns, the analogy ​of auditors flocking to Santyl® claims ​like insects to light is quite fitting.

Pharmacies submitting claims for ​Santyl® ointment should expect future ​audits. The manufacturer provides a ​specialized online calculator ​(https://Santyl.com/hcp/dosing) to ​ensure proper dosing and dispensing. ​For chronic wounds, prescriptions ​must detail the wound’s length and ​width (in centimeters) and treatment ​duration. For burns, the total body ​surface area and number of ​applications are required.

Missing these measurements flags ​prescriptions as non-calculable, ​leading to full recoupment. Auditors ​focus on these high-value claims ​because prescribers and pharmacy ​staff often omit the necessary ​details, resulting in failed audits.

Example Wound Calculation:

Wound dimensions and therapy ​duration: 6 cm x 2 cm for 30 days

Manufacturer calculator: ​Recommends 90 g tube (total 62 g ​needed)

  • 90 g tube calculation:
    • 1.78 cm = 1 g
    • 90 g x 1.78 cm/g = 160.2 cm
    • 160.2 cm / 3.6 cm per ​application = 44.5 days’ supply
  • 30 g tube calculation:
    • 3.04 cm = 1 g
    • 30 g x 3.04 cm/g = 91.2 cm
    • 91.2 cm / 6.2 cm per application ​= 14.7 days’ supply
    • Two 30 g tubes = 29.4 days’ ​supply

Another common issue with Santyl® ​ointment claims is the online ​calculator’s rounding, which can ​cause incorrect days’ supply billing. ​The calculator rounds up to the ​nearest tube size (30 or 90 grams). ​Therefore, pharmacies must ​calculate the true days’ supply to ​avoid dispensing excess ​medication.

Auditors Are Attracted to Santyl® Like Insects to Light (cont..)

MGMT Tips:

  1. Set Up Reminders in Pharmacy Software:
    • Flag the 30 g (NDC 50484-010-30) and 90 g (NDC 50484-010-90) tubes of Santyl® ointment in your ​pharmacy system to remind staff to check the prescription for wound length and width (in centimeters) ​and treatment duration.
  2. Document Measurements for Multiple Wounds:
    • Ensure that measurements and treatment duration are documented for each wound if more than one is ​being treated.
  3. Reevaluate Wound Measurements Periodically:
    • As therapy progresses and the wound size decreases, periodically reassess the wound measurements.
    • Contact the prescriber’s office to obtain a new prescription if the wound size changes.
    • Enter the new measurements into the Santyl® online calculator and adjust the quantity and days’ supply ​accordingly.
    • Note: The Santyl® calculators have a 30-day maximum duration to emphasize the need for regular wound ​reassessment.
  4. Treating Burns:
    • Use the Santyl® manufacturer’s online calculator exclusively for determining the appropriate quantity for ​burns.
    • Remember to back-calculate the correct days’ supply by following the outlined method

    Ensuring Audit Readiness: Key PBM Requirements for Signature Logs and ​Proof of Delivery

    A common concern for pharmacies is understanding ​the audit requirements for signature logs. This article ​outlines critical reminders and requirements that ​auditors focus on to help ensure your pharmacy is ​prepared.

    With the conclusion of the Public Health Emergency on ​May 11, 2023, PBM waivers for signature collection and ​mailing allowances were largely rescinded, except for ​Humana, which extended its mailing waiver until ​December 31, 2023. It is essential for pharmacies to ​remind all staff to collect signatures at the time of ​prescription pickup and delivery. Non-compliance ​could result in significant audit recoupments and a ​cumbersome appeals process.

    During the Public Health Emergency, both pharmacies ​and patients grew accustomed to the absence of ​signature requirements for prescription pickups and ​the convenience of mail or delivery services. However, ​it is now crucial to educate patients about their ​insurance requirements, despite the potential difficulty ​in communication.

    Major PBMs such as Caremark, Humana, OptumRx, ​and Express Scripts allow prescription deliveries, but ​with specific restrictions. These limitations are often ​found in pharmacy contract agreements rather than ​provider manuals.

    Key delivery restrictions by two of the largest PBMs ​include:

    • OptumRx: According to the Pharmacy Provider ​Manual, deliveries must be conducted by a ​pharmacy’s W-2 employee within a 100-mile ​radius. The use of common carriers, including USPS, ​is prohibited.
    • Caremark: The Pharmacy Provider Manual ​specifies that pharmacies delivering more than ​20% of monthly claims via common carriers, ​including USPS, are not classified as “Retail ​Pharmacies.”

    MGMT Tips:

    • Signature Requirement: Ensure staff collect ​signatures for all in-store pickups and deliveries.
    • Log Details: Include the date received in signature and ​delivery logs.
    • No Proxy Signatures: Staff and drivers cannot sign for ​patients.
    • Photo Evidence: Photos or “authorization” to leave ​deliveries are not accepted in PBM audits.
    • Tracking Links: Ensure prescriptions are linked to ​tracking information when using common carriers.
    • Keep Tracking Data: Maintain access to tracking ​information for audits.
    • Out-of-State Compliance: Adhere to licensure ​requirements for out-of-state deliveries.

    Audit Tactics and Tips Diabetic Test Strip Authorized Distributors

    Independent pharmacies are ​frequently receiving threatening ​letters from LifeScan and an affiliated ​law firm. These letters claim that ​pharmacies have submitted more ​claims for LifeScan’s OneTouch ​diabetic test strips to PBMs than their ​purchase history from authorized ​distributors supports. This is ​essentially a covert “invoice audit,” ​and pharmacies only become aware ​of it when they receive negative ​results.

    The letters also threaten to withhold ​rebate dollars owed to PBMs and ​inform PBMs of the pharmacy’s “non-​compliance” unless a substantial ​payment is made to resolve the issue.

    Pharmacies often seek to lower their ​costs to either make a small profit or ​minimize losses, given that PBMs ​control the selling price of insured ​claims. However, this approach can ​be problematic when trying to adhere ​to PBM contractual requirements and ​ensuring that products obtained are ​legitimate.

    Diabetic test strips, classified by the FDA as OTC medical devices, are not covered by the Drug Supply Chain ​Security Act (DSCSA). This means ​there is no requirement for a ​“pedigree” to verify that the products ​are legitimate and not stolen, ​counterfeit, or previously dispensed ​(gray market). Pharmacies must be ​cautious when sourcing products ​advertised at lower costs than their ​primary wholesaler. Manufacturers ​maintain “lists” to help supply chain ​partners like pharmacies.

    Understanding PBM requirements is ​crucial. While OptumRx does not ​explicitly require pharmacies to ​purchase test strips from authorized ​distributors, it does mandate that ​pharmacies source all products from ​vendors licensed as drug wholesalers ​in the state and accredited by NABP. ​Both Caremark and Express Scripts ​require network pharmacies to ​purchase test strips only from ​authorized distributors.

    Additionally, California and New ​Jersey have specific regulations ​regarding the purchase and ​distribution of OTC diabetic test strips.

    MGMT Tips:

    • Carefully navigate the ​intersection of state pharmacy ​regulations, PBM contract ​requirements, and ​manufacturer distribution ​channels when making ​inventory purchases. Opting ​for the lowest price might lead ​to non-compliance issues.

    Metformin HCl ER – Audit Considerations

    Metformin HCl ER is used alongside diet and exercise to improve glycemic control in adults with type 2 diabetes ​mellitus, particularly for patients who experience gastrointestinal side effects from the non-ER version. However, its ​higher cost, especially for brands like Glumetza® or Fortamet®, increases the likelihood of audits.

    Adding to the complexity, there are three distinct versions of metformin HCl ER, each with a different extended-​release mechanism. These versions are not interchangeable and have unique Therapeutic Equivalency (TE) codes, ​indicating which generic products can be substituted for specific brand names. When multiple branded versions of ​the same active ingredient, form, and route of administration exist, the FDA assigns additional identifiers such as AB, ​AB1, AB2, and AB3 to distinguish them.

    You may only dispense a generic formulation of the above if the TE code matches.

    MGMT Tips:

    • Justify High-Cost Medications: Dispensing expensive medications without lower-cost alternatives can trigger PBM ​audits. Auditors may request prescriber clarification.
    • Document Clinical Reasons: When switching a patient to metformin HCl ER due to side effects, note the rationale ​on the prescription.
    • Limit Bulk Switching: Switching many patients to metformin HCl ER may attract audits and accusations of ​solicitation.
    • Clarify Generic Prescriptions: Confirm with the prescriber which metformin HCl ER version is preferred and ​document the conversation.
    • Get Approval for TE Code Substitutions: For substitutions between versions with different TE codes, obtain and ​document prescriber approval.
    • Use FDA Orange Book: Identify TE codes using the FDA Orange Book (https://www.fda.gov/drugs/drug-approvals-​and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book).

    2024 Self-Audit Series: Topical Prescriptions

    Topical medications are prime targets for audits, ​especially given their increasing costs. A common issue ​cited is “non-calculable instructions,” meaning the PBM ​believes the pharmacy cannot accurately bill the days’ ​supply based on the prescription’s instructions. ​Pharmacies will need additional information, typically a ​prescriber’s statement, to appeal these findings.

    Pharmacies must ensure accurate billing by verifying ​prescription details. Prescriptions specifying the number ​of grams per application and frequency can be billed ​accurately. Clarify vague instructions with the prescriber ​and document this clarification both on the prescription ​and the patient’s label, as required by OptumRx.

    Do not rely on the days’ supply field in electronic ​prescriptions, as PBM auditors do not accept this. ​Prescriptions with a quantity of “1” are often flagged for ​“incomplete quantity.” Auditors require a specific quantity ​in grams, milliliters, or pumps. Thorough verification and ​documentation can help prevent audit recoupments.

    MGMT Tips:

    • Staff Training: Ensure staff are trained to review ​topical prescriptions for complete and clear ​instructions before filling.
    • Frequent Self-Audits: Regularly self-audit expensive ​topical prescriptions to confirm instructions are ​sufficient for passing audits.
    • Fill on Request Only: Dispense topical medications ​only upon patient request.
    • Detailed Clinical Notations: Clinical notes must ​include the date, the name and title of the person you ​spoke with, the details clarified, and your initials.

    Insulin for Use in a Pump – Keep Your Earnings Out of the PBM’s Pocket

    Considerations for Billing Insulin Vials: Medicare Part B vs Part D

    Metformin HCl ER is used alongside diet and exercise to improve glycemic control in adults with type 2 diabetes ​mellitus, particularly for patients who experience gastrointestinal side effects from the non-ER version. However, its ​higher cost, especially for brands like Glumetza® or Fortamet®, increases the likelihood of audits.

    Adding to the complexity, there are three distinct versions of metformin HCl ER, each with a different extended-​release mechanism. These versions are not interchangeable and have unique Therapeutic Equivalency (TE) codes, ​indicating which generic products can be substituted for specific brand names. When multiple branded versions of ​the same active ingredient, form, and route of administration exist, the FDA assigns additional identifiers such as AB, ​AB1, AB2, and AB3 to distinguish them.

    MGMT Tips:

    • Even if the pharmacy is unable to bill ​insulin to Medicare Part B, this ​determination must still be made to ​prevent chargebacks.
    • If the patient has a Medicare ​Advantage plan, the insulin should be ​billed to that plan.

    When billing insulin vials for use in a pump for Medicare-eligible patients, it’s crucial to determine whether to bill ​Medicare Part B or Part D. Follow a flowchart with four key questions to identify the correct payor.

    Insulin for Use in a Pump – Keep Your Earnings Out of the PBM’s Pocket (cont..)

    MGMT Tips:

    • Only rapid-acting insulin is FDA-approved for use in pumps.
      • Long-acting, pre-mixed, and concentrated insulins are NOT approved for use in pumps.
    • There are two types of insulin pumps:
      • Disposable (tubeless) pumps such as V-Go, Omnipod, and CeQur Simplicity™
        • These do not meet Medicare Part B requirements and should be billed to Part D.
      • Durable (tubed) pumps
        • These are covered by Medicare Part B if eligibility criteria are met.
    • When receiving a prescription for insulin vials, PAAS recommends the following steps:
      • Determine if the patient is Medicare eligible.
      • Confirm whether the prescription is for rapid-acting or long-acting insulin.
      • Verify if the patient is injecting insulin or using it in a pump.
      • Identify the type of insulin pump the patient is using (durable or disposable).
        • If it is a durable pump, ensure the patient meets Medicare Part B eligibility criteria.
    • Medicare Part D plans typically do not reject insulin claims at the point of sale, so these must be monitored.
    • Even if your pharmacy is not enrolled as a Medicare Part B supplier, you must still know how the patient is using ​their insulin, as this determines which Medicare benefit is responsible for payment.
    • Check out the Insulin Flow Chart from MGMT for further guidance.

    2024 Self-Audit Series: Topical Prescriptions

    Below is a list of drugs reviewed and analyst ​comments compiled from the first six months of 2024 ​for comparison.

    Top 5 Drugs Reviewed: 2024 (January-June) vs. 2023 ​(January-December)

    January-June 2024

    January-December 2023

    Ozempic®

    Lantus®

    Nurtec®

    Humalog®

    Mounjaro®

    Creon®

    Creon®

    Levemir®

    Ubrelvy®

    Invega®

    While Creon® remains a significant target for PBMs, the ​first half of 2024 shows a shift in focus from insulin ​claims to GLP-1s and migraine medications. This shift ​highlights the evolving trends in PBM audits. Despite ​this change, insulin claims reviews are still prevalent. ​Although they don’t appear in the top five for 2024 so ​far, Tresiba®, Humalog®, Levemir®, insulin lispro®, and ​Toujeo® closely follow Ubrelvy® in the number of claim ​reviews issued by PBMs to date.

    Top 5 Analyst Comments After Claim Reviews ​(Consistent with 2023):

    1. Document the Reason for Cut Quantity: Auditors ​need to know why the pharmacy dispensed less ​than what was prescribed.
    2. Black Out Acquisition Cost and Profit Margin on ​the Backtag.
    3. Clinical Notation Requirements:
      • Date
      • Name and title of the person you spoke with
      • Confirmation details
      • Pharmacy employee initials
    4. No Backtag/Sticker Attached: Typically requested ​by PBMs and useful for Auditors to review billing ​elements.
    5. Verify and Document Prescribed Quantity: Ensure ​the Unit of Measure (UOM) is specified and ​appropriate for the medication ordered, and make ​a clinical notation on the hard copy.

    The Impact of 28-Day Supply vs. 30-Day Supply Fills

    Navigating the world of prescriptions can be complex, particularly when understanding the nuances between ​different days’ supply schedules. For many prescriptions, the distinction between a 28-day supply and a 30-day ​supply can significantly impact your audit results.

    Weekly medications are typically prescribed to be taken once every seven days, meaning a 28-day supply ​covers four weeks of treatment.

    Monthly medications are generally prescribed to be taken once every 30 days, ensuring patients receive one ​dose per month, aligning with their treatment schedules.

    Understanding these differences is crucial as they can influence your audit outcomes.

    Examples of Correct Billing for 28-Day and 30-Day Supplies:

    Medication

    Quantity

    Dosage

    Billing

    Invega Sustenna

    234 mg/1.5 mL

    1 syringe

    234 mg intramuscularly every 4 weeks

    28-day supply

    Invega Sustenna

    234 mg/1.5 mL

    1 syringe

    234 mg intramuscularly every month

    30-day supply

    Humira 40 mg

    2 pens

    40 mg every other week

    28-day supply

    Enbrel 50 mg

    3.92 mL (4 pens)

    50 mg subcutaneously once a week

    28-day supply

    Methotrexate 2.5 mg

    32 tablets

    8 tablets on the same day each week

    28-day supply

    When audits are performed, discrepancies in the 28-day vs. 30-day supply are typically educational if there are ​no early refills or overbilled quantities. However, Humana imposes a $5.00 administrative fee (per refill) to ​correct any invalid educational days’ supply.

    MGMT Tips:

    • Always bill the precise days’ supply based on the quantity and directions provided. Contact the physician if ​any information is missing to ensure you are submitting a valid claim.
    • Do not assume the days’ supply field on an electronic prescription is correct, as it is often defaulted.
    • Ensure that the frequency on the prescription matches the instructions on the patient label.
    • Prescriptions ordered once weekly should be billed as a 28-day supply, while those ordered once monthly ​should be billed as a 30-day supply.
    •  

    Filling and Billing Tips Proper Billing of Nayzilam® and Valtoco® Nasal Sprays

    Some patients with epilepsy experience seizure clusters despite being on maintenance medications. Nayzilam ​and Valtoco are FDA-approved for the “acute treatment of intermittent, stereotypic episodes of frequent seizure ​activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern” for ​patients 12 years and older and 6 years and older, respectively. However, billing for Nayzilam and Valtoco can be ​complex, allowing PBMs to easily recoup funds if not done correctly.

    Steps for Proper Billing:

    1. Verify Prescription Details:
      • Ensure the prescription has clear directions and the correct quantity prescribed.
    2. Dosage Instructions:
      • Nayzilam:
        • Initial dose: One spray into one nostril.
        • If needed, and if directions support, an additional spray may be administered into the opposite nostril ​10 minutes after the initial dose if the patient does not respond.
      • Valtoco:
        • The number of sprays per dose depends on the prescribed strength.
        • For 5 mg and 10 mg strengths: One spray into one nostril.
        • For 15 mg and 20 mg strengths: Two sprays (one into each nostril).
        • If needed, and if directions support, a second dose may be administered at least 4 hours after the ​initial dose if the patient does not respond.
    3. Calculate Days’ Supply:
      • Determine the maximum number of episodes the patient is allowed to treat per month to accurately ​calculate the days’ supply.
      • Nayzilam:
        • No more than two doses should be used to treat a single episode.
        • It should not be used to treat more than one episode every three days, with a maximum of five ​episodes per month.
      • Valtoco:
        • No more than two doses should be used to treat a single episode.
        • It should not be used to treat more than one episode every five days, with a maximum of five episodes ​per month.

    Refer to the chart below and MGMT Tips for recommended billing guidance and other necessary prescription ​components to protect your pharmacy from audit recoupments.

    MGMT Tips:

    • If any clarifications are needed regarding the directions, include a full clinical note. This should include the date, the ​name and title of the person you spoke with, the details of the communication, and your initials.
    • Ensure that both the quantity and unit of measure are clearly indicated on the prescription. For example, “2 boxes” and “2 ​EA” will result in different billing outcomes.
    • Record the number of episodes the patient will be treating per month to ensure accurate billing and usage, paying close ​attention to refill intervals.
    • Nayzilam and Valtoco are both classified as C-IV controlled substances, requiring all elements of a valid controlled ​substance prescription on the hard copy. This includes the patient’s address, the physician’s address, and the ​physician’s DEA number.

    Medicare Part B/DMEPOS 2024 DMEPOS: Urological Supplies (Intermittent Catheters)

    Many pharmacies struggle with DMEPOS audits due to the complexity of medical billing and the stringent ​documentation requirements. Medicare Part B suppliers must be able to produce all required documentation if ​audited, ensuring it meets Medicare Part B standards. This DMEPOS series aims to help you navigate these ​complexities and gather the necessary documents.

    Key Documentation for Audits Involving Intermittent Catheters:

    1. Standard Written Order (SWO)
    2. Medical Records:
      • The beneficiary must have permanent urinary incontinence or retention.
      • “Permanent” is defined as a long and indefinite duration of at least three months.
      • The impairment is not expected to be surgically or medically corrected within three months.
      • Urological supplies are an exception to requiring proof of continued need. Once the initial medical need is ​established, ongoing need is assumed due to the permanent condition.
    3. Proof of Delivery
    4. Proof of Refill Request and Affirmative Response:
      • Required if supplies are delivered or mailed.

     

    Coverage Criteria for Intermittent Catheterization:

    • The beneficiary or caregiver must be able to perform the procedure.
    • For each episode, Medicare will cover:
      • One catheter: A4351 (straight tip) or A4352 (coudé or curved tip), and an individual pack of sterile ​lubricant A4332, OR
      • One sterile intermittent catheter kit: A4353.

     

    Sterile intermittent catheters must meet at least one of the following requirements:

    • The patient is a nursing facility resident.
    • The patient is immunosuppressed.
    • The patient has radiologically documented vesico-ureteral reflux.
    • The patient is a pregnant female with spinal cord injury and neurogenic bladder (coverage is for the duration ​of pregnancy only).
    • The patient has had at least two urinary tract infections (UTIs) within 12 months while using A4351/A4352 and ​sterile lubricant A4332.

     

    Maximum Quantity Allowance:

    • Up to 200 intermittent catheterization supplies per month for codes A4332, A4351, A4352, and A4353.

     

    By understanding and adhering to these guidelines, you can better manage your DMEPOS audits and ensure ​compliance with Medicare Part B requirements.

    MGMT Tips:

    • The medical necessity for coudé (curved-tip) catheters must be substantiated by documentation in the medical record. ​The use of coudé tip catheters, particularly for female patients, is seldom deemed reasonable and necessary.
    • Review documentation checklist for Jurisdiction A and D
    • Review documentation checklist for Jurisdiction B and C
    • Review the Urological Supplies LCD and Policy Article