Are Your Patients Running Out of Supplies for Their Continuous Glucose Monitor?

Pharmacies often struggle with audits for DMEPOS items. The Medicare Part B/DMEPOS billing model is a complex maze of units, codes and documentation requirements that are very different from billing traditional prescription drugs. This model produces high error rates and recoupments across the country. You must have a strong understanding of these differences to prevent audit recoupment. This article discusses how to bill supplies for Continuous Glucose Monitors (CGMs).

PAAS Tips:

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  • When a CGM Receiver/Monitor code of K0554 is covered, the related supply “allowance” code K0553 is also covered
  • A monthly supply allowance includes all supply items needed for the patient to use the non-adjunctive CGM. These supply items may include transmitters, sensors, batteries, strips, lancets, and control solution for a Blood Glucose Monitor (BGM)
  • Use the following steps to prevent patients from running out of supplies before month end
    • Only bill 1 unit of service (UOS) for HCPCS code K0553 per month
    • 1 UOS equals 1 month’s supply no matter if 28, 29, 30 or 31 days in the month
    • If using a FreeStyle Libre, providing 2 (14-day) sensor packs will leave the patient short on days 29, 30 or 31
    • The following example from the Medicare Learning Network®  is a way to ensure the patient has enough supplies per calendar month
      • April – 30 calendar days: Provide 3 sensors (42-day supply)
      • May – 31 calendar days: Proved 2 sensors (28-day supply) since the patient should have 12 days remaining from the previous month
      • June – 30 calendar days: Provide 2 sensors (28-day supply) since the patient should have 9 days remaining from the previous month
    • Pharmacy will need to dispense 3 (14-day) sensors twice per calendar year
    • Check with patients often to see what supplies they need and send enough to meet the next month’s supply need
    • Remember, Medicare pays a bundled rate for the 1 UOS each month so you are still getting paid for the two extra sensors provider through the year. See the July 2021 Newsline article, Are You Billing Continuous Glucose Monitors Correctly?

Updated COVID-19 Vaccine Attestations Plus Resource and Billing Chart on PAAS Member Portal

On March 29, 2022, the CDC and FDA issued press releases to provide updated COVID-19 vaccine recommendations. In addition to the primary series and initial booster dose, they authorized an additional mRNA booster dose for people over the age of 50 and for certain immunocompromised individuals. The additional booster dose can be given if at least 4 months have passed since the patient received their first booster dose.

Keeping track of which patients are eligible, when they are eligible, and having documentation to confirm their eligibility can be a tiresome task with the constantly revised recommendations. PAAS National® has continued to update the COVID-19 Vaccine Self-Attestation form in an effort to streamline the COVID-19 vaccination screening process for pharmacies. There is a self-attestation form for immunocompromised patients obtaining an additional dose to complete their primary series and a form for patients obtaining a booster dose. Each form conveniently displays eligibility criteria including patient age, a sample list of qualifying patient conditions, and appropriate dosing intervals, and provides links to additional resources.

In addition to the self-attestation form, the COVID-19 Vaccine Resource & Billing Chart has also been updated to reflect the newest recommendations for a second booster and information on the new Moderna COVID-19 vaccine to be used only for booster doses (NDC 80777-0275-XX). The Moderna COVID-19 vaccine vials with a dark blue cap and label with a purple border are to be used only for booster doses and require 0.5 mL for the 50 mcg dose as opposed to the original Moderna COVID-19 vaccine vials with a red cap and label with a light blue border (NDC 80777-0273-XX) which require only 0.25 mL for the 50 mcg booster dose.

We recommend frequently checking the COVID-19 Resources tab on the PAAS Member Portal for the most up-to-date self-attestation forms, COVID-19 Vaccine Resource & Billing chart, and COVID-19 PBM Concessions document. Additionally, thank you to those pharmacies who have forwarded us PBM communications regarding the pandemic and COVID-19 waivers. We appreciate your time and efforts and would like to remind pharmacies to continue to forward those PBM notifications to PAAS as they may be valuable for future audits.

PAAS Tips:

  • Maintain proof of eligibility for patients receiving a COVID-19 vaccine
  • Ensure your COVID-19 vaccines claims are audit ready
    • Review the March 2022 Newsline article, Best Practices for Vaccine Documentation for additional guidance
    • Upon audit, provide the patient self-attestation form along with the vaccine hardcopy or placeholder hardcopy (if working off the PREP Act or standing order) and the vaccine administration record
  • To date, NCPDP has not released additional guidance regarding Submission Clarification Codes (SCC) for the additional booster dose; therefore, continue using SCC 10

Excluded Individual Creates Chaos for A Pharmacy IF Not Caught Right Away!

PAAS National®’s Fraud, Waste and Abuse & HIPAA Compliance Program monitors the Office of the Inspector General (OIG) and General Services Administration (GSA) lists daily for our members, even though the requirement is monthly. The program allows members to print exclusion list checks and stores this documentation electronically. PBMs will often request this proof of exclusion checks during an audit. PAAS Audit Assistance members can see our September 2021 Newsline article, OIG and GSA Exclusion Checking – Are You Compliant?.

Recently PAAS identified an excluded individual as an exact match through our proprietary exclusion checking offered by the Fraud, Waste & Abuse and HIPAA Compliance Program. The Pharmacist-in-Charge was called immediately. PAAS’s quick actions prevented this excluded individual from working in the pharmacy, saving the owner a lot of heaches – fines and additional repercussions.

  • What is an excluded individual?
    • An excluded individual has been identified by the OIG and/or the GSA as a person who is not allowed to be involved with any acts or services that are associated with Federal healthcare payments (Medicare or Medicaid). This includes ordering, prescribing, fulfilling orders, or providing services.
  • What causes an individual to become excluded?
    • Conviction of a crime related to federal healthcare programs, patient abuse or neglect, felony conviction related to controlled substances, participating in other healthcare fraud, defaulting on health education loan, or other reasons.
    • See more information on the OIG website
  • What are the consequences of hiring an excluded individual?
    • Hiring an excluded individual is a direct violation of Medicare Part D contracts
    • Items or services involving an excluded individual in any way cannot receive reimbursement from Medicare or Medicaid.
    • The pharmacy may be required to pay up to $10,000 each claim that the excluded individual was involved in as well as up to three times the damages incurred from these claims.
    • A pharmacy owner and pharmacist employee recently agreed to pay $250,000 to resolve False Claims Act liability related to employing an excluded individual

PAAS Tips:

  • The pharmacy Compliance Officer should screen every individual for OIG and GSA exclusions prior to hire, monthly thereafter, or in accordance with state laws. This includes:
  • These exclusion list searches should be documented and retained for 10 years.
  • Enter the hired person’s name into the exclusion review system exactly as it appears on their state or federally issued form of identification in order to ensure integrity of the check
    • Keep in mind, excluding individuals often try to hide their identity by changing their name or using a different name – don’t take a chance.

On-Demand Webinar: Compliance Issues, HIPAA Enforcement and Audit Risks with COVID-19

On April 7, 2022 PAAS National® hosted Compliance Issues, HIPAA Enforcement and Audit Risks with COVID-19 webinar. PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Member Portal.

This webinar reviews:

  • Compliance Program Requirements (and why it matters to community pharmacies)
  • HIPAA Enforcement/Action
  • COVID-19 Vaccine Audit Risks (updated)
  • OTC COVID-19 Tests Audit Risks (and Medicare B guidance)
  • Onsite Audit Preparation

Yes, OTC COVID-19 Tests Can Be Audited!

Dispensing OTC COVID-19 tests is widespread through community pharmacies. Pharmacies must be aware that submitting claims to PBMs for these tests opens the window for auditing. Ensuring you have procedures in place to accurately purchase, bill and dispense these home tests is imperative. While the dollar amount of these claims does not seem audit worthy, PBMs will be checking for Fraud, Waste and Abuse and contract violations.

PAAS National® has created a COVID-19 Resources section for our members on the PAAS Member Portal. Here you can find the Patient Request and Attestation for OTC COVID-19 Test Billing and Frequently Asked Questions. These documents have been created for our members to help answer questions and ease the documentation burden so pharmacies can save time and be audit ready.

Recently, a PAAS member received an audit request and results for an invoice audit targeting OTC COVID-19 tests. The audit was for a very short time frame and the PBM had already contacted patients to verify what manufacturer and quantity of tests the patient had received. Only tests that have been authorized by the FDA should be billed and dispensed. You can find a list of approved tests here.

PAAS Tips:

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Medi-Span® Generic Product Identifier

Health Information Technology vendors in the pharmacy industry utilize large drug compendia databases to manage electronic drug files so that electronic transactions are all “speaking the same language”. The two largest databases are Medi-Span® and First Databank.

These compendia have hundreds of datapoints for every drug product in the marketplace and some of these datapoints may be subject to frequent changes (e.g., pricing fields such as AWP, WAC, NADAC, etc.) while others are static (e.g., unit of measure).

Drug wholesalers (e.g., McKesson) and Pharmacy Software Management Systems (e.g., PioneerRx) rely on these drug compendia to build out their platforms and regularly update pricing files.

Medi-Span® uses a proprietary14-digit hierarchy system called Generic Product Identifier (GPI) to organize drug products at seven levels including drug group, class, subclass, base, name, dose form, and dose strength. Unfortunately, this hierarchy does not include information about FDA therapeutic equivalency which may lead pharmacies to come to the wrong conclusion about which products may, or may not, be substituted without prescriber approval.

Wholesaler online ordering systems and Pharmacy Software that rely on GPI hierarchy alone may yield both false positives (imply that products may be substituted) and false negatives (imply that products may not be substituted).

Examples that may cause problems include:

  1. BX rated generics
  2. Albuterol sulfate inhalers
  3. Insulin glargine products (Lantus®, Basaglar®, Semglee®)

The best resources to determine if products may be substituted without prescriber approval are the FDA Orange Book and Purple Book.

PAAS Tips:

  • Review FDA Orange Book or Purple Book for information about equivalency and interchangeability
  • Call PAAS National® at (608) 873-1342 if you are unclear if products may be substituted without prescriber approval
  • Find more details about Medi-Span® GPI here

Audit Issue: Patient or Prescriber Denials of Prescriptions

PAAS National® analysts have seen numerous PBM audit results where pharmacies had recoupments related to patient or prescriber denials of medications. Pharmacies are able to appeal by obtaining signed statements to overturn the denials.

In certain instances, such as investigations, PBMs are reaching out to both patients and prescribers to validate pharmacy claims. Presumably, PBM auditors/investigators are independently collecting evidence to ensure that “the stories match” to determine if pharmacies are acting in good faith. Unfortunately, they typically presume guilt until proven innocent.

Patients may be sent official letters from PBMs asking various questions detailing the interaction with your pharmacy. Here are some common questions that letters may include:

  1. Did you receive the following prescriptions?
  2. Did you authorize the pharmacy to refill the following prescriptions?
  3. Did you pay the copay?
  4. Did the pharmacy offer you a discount on your copay?
  5. How did you receive the following prescriptions (in-person, delivery, mail)?

Some patients may not remember the details of a prescription from years ago, or be scared to answer incorrectly, and decide to not respond. If a patient fails to respond to such a request, this non-response may be deemed a denial, and thus the pharmacy is presumed guilty.

Additionally, PBMs are reaching out to prescribers to determine if prescriptions were authorized to confirm legitimacy. Like patient denials, a non-response from a prescriber’s office paints the pharmacy as guilty (even if you have a date/time stamped electronic prescription – absurd!). Other issues that may come up include prescriber moving practices, retiring or if the pharmacy accidentally billed the claim under the wrong prescriber’s NPI.

If you receive audit results that include recoupments for patient or prescriber denials, consider the tips listed below to help you in your response.

PAAS Tips:

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  • Send audit results to PAAS for assistance in developing an appeal strategy
    • The foundation of an appeal will include signed statements from patients or prescribers to overturn the findings
    • Each PBM has unique requirements for such statements, make sure you understand the fine print
  • It is important to consider documentation already in your possession that can help support your case such as prescriptions or signature logs
  • It is helpful to understand if denials are passive (respondent did not respond) or active (respondent actively denied)

Insulin for a Pump – Medicare B or Medicare D?

PAAS National® analysts are frequently asked how insulin for a pump should be billed for Medicare eligible patients. Incorrect billing has caused very high dollar recoupments for some pharmacies. Be sure you know how to correctly bill your patients’ insulin.

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Insulin pumps currently fall under two categories, durable (tubed) or disposable (tubeless). Medicare coverage for insulin used in a pump will be determined by what type of pump the patient is using. Two examples of disposable or tubeless insulin pumps are the Omnipod® and the V-Go®. Because patients are required to discard and replace the insulin reservoirs, this categorizes them as disposable. Medicare Part D would cover insulin used in these types of insulin pumps.

Pharmacies must be mindful when dispensing insulin vials for Medicare eligible patients. Medicare Part D plans will not reject insulin claims, so you must monitor these closely. Not every prescription will state if it is used in a pump. Patients not receiving insulin syringes to use with insulin vials could indicate a pump is being used. PAAS recommends asking patients for confirmation of injecting or using in a pump prior to dispensing. See Billing the Correct Insulin for Use in a Pump in this month’s Newsline for types of insulin covered/not covered when used in a pump.

PAAS Tips:

  • When receiving a prescription for insulin vials PAAS recommends the following:
    • Identify if patient is Medicare eligible
    • Check if patient is injecting insulin, or if it is being used in a pump
    • Identify what type of insulin pump the patient is using, durable or disposable
      • If durable, was pump covered by Part B?
    • Self-audit prescriptions for insulin vials to ensure billing was done correctly
    • Contact PAAS National®® for additional questions regarding insulin for a pump

Caremark Complex Compounds

PAAS National® analysts have recently worked with multiple pharmacies that received Compound Contract Violation notices from Caremark stating that the pharmacy must cease and desist submitting claims for “complex compounds” and reverse claims provided on an attached list. Letters state that failure to comply could result in network termination. In one instance, the notice was labeled “Second notice” and referred to a previously issued “First notice” reportedly issued in 2020, however the pharmacy had no record of the prior notice.

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In each case, pharmacies reported that the claims were all non-sterile compounds, many of which were oral suspensions made with crushed tablets or topical creams made with bulk powders. Additionally, pharmacies stated that claims were paid at point-of-sale with no reject messages or need for overrides or prior authorizations.

Caremark’s definition of “complex compounds” is not included in the notices sent to pharmacies, nor does it appear in the Pharmacy Provider Manual. Additionally, it is not related to the Level of Effort value submitted. PAAS first saw the definition provided in an Addendum to Caremark Provider Agreement Compounding: Limited Scope of Pharmacy Services in 2014 and was presented at the time as shown below:

‘A non-complex compound is compound that is not complex, and a “complex compound” is defined as a compound that meets any one of the following three (3) elements:

(1) a mixture of chemicals that involve bulk chemicals (API), aliquots, or dissolutions of tablets and/or capsules;

(2) the route of administration does not remain in accordance with FDA-approved labeling/indications for each ingredient contained within the compound; or

(3) requires specialized equipment (unguator, ointment mill, etc.), training, or gowning or requires special environmental conditions to protect pharmacy staff and public.’

PAAS Tips:

  • See Section 2.02 of the 2022 Caremark Provider Manual for more details on becoming a complex compound provider for Caremark
  • Contact Caremark at CompoundApplicationTeam@CVSHealth.com to request authorization to bill complex compounds
  • It is unclear how serious Caremark is about this issue based on the issuance of multiple notices over many years without consequences and no hard rejections at point-of-sale

Cash Copay Collection

Numerous PBMs are conducting audits and asking for proof of copay collection. This is relatively easy to respond to (albeit annoying) when patients have paid by check or credit card as there is a “paper trail” of the financial transaction. PAAS National® analysts have seen some pharmacies struggle to provide evidence of cash transactions as they do not have sophisticated point-of-sale systems that record the method of payment or they lack consistent cash handling policies and procedures, or both.

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Of particular concern recently has been Caremark, who requires that pharmacies provide bank deposit slips as evidence of cash copays (the final step in the “paper trail” evidence). While, clearly, individual bills received from a patient at the register cannot be linked to a particular transaction, Caremark may be suspicious of large copays paid in cash and will demand to see bank deposit slips that exceed (in the aggregate) the amount of the individual copay.

If your pharmacy cannot provide sufficient evidence of copay collection, then PBMs may recoup claims during audit and potentially terminate your pharmacy agreement.

Consider the PAAS tips below to strengthen your cash handling procedures where needed.

PAAS Tips:

  • Don’t wait for an audit, with Proof of Copay Collection requirements, to upgrade to an integrated Point-Of-Sale system. Benefits may include:
    • Creation of itemized sales receipts with date and time of sale, individual items sold, dollar amount of each item (e.g. copay) and method of payment received
    • Additional features often include:
      • Incorporate electronic signatures as proof of dispensing and acknowledgement of HIPAA notice of privacy practices
      • Link to OTC inventory levels for reporting and automatic reorder points
      • Link to pharmacy dispensing software to update a work queue, mark prescriptions as “sold” or even hard-stop prescriptions if trying to sell a certain number of days after fill date (may prevent dispensing beyond PBM return-to-stock window)
      • Query transactions such as when responding to a PBM audit or if a customer disputes payment amount or receipt of a medication at a later date
    • Develop or revise cash handling policies that include:
      • Making deposits to the bank at regular intervals (e.g., weekly)
      • Avoid taking money out of the register to run the business (e.g., buying stamps, staff lunch, etc.)
      • Balance the register at the end of every business day
        • Breakdown cash by denomination and document for comparison against the next deposit
        • Leave a set minimum amount for open of next business day
        • Additional funds should go into a safe until the next scheduled bank deposit
        • If you have a point-of-sale system, it should be able to reconcile every transaction of the day to ensure you have the right amounts on-hand and identify any lost payments or theft