Back to School: How to Ace EpiPen® Billing and Avoid an Audit  

PAAS National® has seen an increase in prescription validation requests and audits for EpiPen® and, with back-to-school in full swing, we want all pharmacy employees to be aware of potential billing issues for this life-saving medication.

According to section 1 Indications and Usage of the FDA product labeling, “EpiPen® and EpiPen Jr® are indicated for the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.”

Emergency medications are frequently audited, and EpiPens® have their own unique set of audit issues, including:

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  1. Quantity billed
  2. EpiPen® is billed as an “each”, so a 2-pack would be billed as “2 each”
  3. If multiple boxes of EpiPens® are required at one time, it is advisable to verify with the prescriber why such a quantity is needed (e.g., one for home and one for school, one in each household, one for gym bag, school bag, and daycare, etc) and make a clinical note on the prescription
  4. Mathematically calculable directions
  5. Directions that come over as “Use as directed” should generally be clarified with the prescriber as to whether the patient is to “use as directed per package instructions” in addition to updating the patient label directions accordingly
  6. Days’ supply
  7. If a 2-pack is prescribed with directions indicating the patient may repeat the dose after a certain amount of time, billing a 1-day supply would be appropriate
  8. If a 2-pack is prescribed with directions that do not indicate a repeat dose, then a 2-day supply would be appropriate
  9. Risk of audit recoupment for incorrect days’ supply is generally limited as PBMs have more tolerance for life-saving medications that are refilled on an as needed basis (rather than scheduled). Additionally, the submission of a 1-day supply versus a 2-day supply is unlikely to impact patient copay, pharmacy reimbursement, or an early refill.
  10. Product dispensed
  11. Epinephrine has many BX-rated products to EpiPen®, and pharmacies need to obtain prescriber approval before dispensing one of these products if the prescription was written for EpiPen®
    1. Conservatively, any indication on a prescription that a prescriber intended to prescribe EpiPen® (or its AB-rated generics) should be clarified before dispensing a BX-rated generic.
  12. Prescriptions written generically as “Epinephrine (EpiPen)”, or with an NDC indicating EpiPen® (or an AB-rated generic), should be interpreted as EpiPen

Common EpiPen®/epinephrine NDCs, and their associated TE Codes, are as follows:

ProductNDCManufacturerFDA Orange Book TE CodeMarketing Category
EpiPen® 0.3 mg/0.3 mL49502-0500-02Mylan Specialty L.P.ABNDA
Epinephrine 0.3 mg/0.3 mL49502-0102-02 Mylan Specialty L.P.ABNDA Authorized Generic for EpiPen®
Epinephrine 0.3 mg/0.3 mL00093-5986-27Teva Pharmaceuticals USAABANDA
Epinephrine 0.3 mg/0.3 mL00115-1694-49Amneal PharmaceuticalsBXNDA Authorized Generic for Adrenaclick®
Epinephrine 0.3 mg/0.3 mL80425-0264-01Advanced Rx Pharmacy of TennBXNDA Authorized Generic for Adrenaclick®
Auvi-Q® 0.3 mg/0.3 mL60842-0023-01KaleoBXNDA
ProductNDCManufacturerFDA Orange Book TE CodeMarketing Category
EpiPen Jr® 0.15 mg/0.3 mL49502-0501-02 Mylan Specialty L.P.ABNDA
Epinephrine 0.15 mg/0.3 mL49502-0101-02 Mylan Specialty L.P.ABNDA Authorized Generic for EpiPen Jr®
Epinephrine 0.15 mg/0.3 mL00093-5985-27Teva Pharmaceuticals USAABANDA
Epinephrine 0.15 mg/0.3 mL63629-8801-01Bryant Ranch PrepackABANDA

PAAS Tips:

  • Clarify quantities if missing the unit of measure (each) or if the unit of measure is “unspecified”
  • Clarify directions if ambiguous or “use as directed”
  • Ensure the patient label directions match any clarification with the prescriber
    • Clinical notes should include four elements:
  • Date
  • Name and Title of who you spoke with
  • Summary of conversation
  • Pharmacy employee initials
  • Do not place emergency medications on auto-refill

The Double Threat: Ransomware Attack Followed by HIPAA Non-Compliance Settlement

Imagine getting a papercut then moments later, cleansing your hands with alcohol hand sanitizer—you can almost feel the instantaneous sting the alcohol causes in the fresh wound. Not only are you subjected to the initial affliction, but also the second round of pain from the alcohol in the wound. Now, imagine a deeper “cut” directed this time at your pharmacy. The initial barrage is a malicious ransomware attack to capture your pharmacy’s electronic protected health information (ePHI), and the secondary “sting” comes when the Office for Civil Rights (OCR) investigates the pharmacy’s policies and procedures. The pharmacy then forks over a hefty monetary settlement for HIPAA Rule non-compliance. Ouch!

A health system servicing patients in Pennsylvania, Ohio and West Virginia found themselves in this exact scenario. According to the published OCR Resolution Agreement and Corrective Action Plan, the OCR initiated a compliance review of Heritage Valley Health System (HVHS) after media reports that HVHS experienced a data security incident. The following HIPAA Security Rule non-compliance issues were identified:

  • Failure to “conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity and availability of all of its ePHI”
  • Failure to “establish and implement policies and procedures for responding to an emergency or other occurrence, such as a fire, vandalism, system failure, and natural disaster, that damages systems that contain ePHI”
  • Failure to “implement technical policies and procedures for electronic information systems that maintain ePHI to allow access only to those persons or software programs that have been granted access rights”

HVHS settled with OCR for a whopping $950,000, agreed to three years of OCR monitoring, and were required to take steps to resolve potential violations of the HIPAA Security Rule.

In addition to detailing the settlement with HVHS, OCR’s July 1, 2024 press release stated there has been a 264% increase in large breaches reported to OCR involving ransomware attack since 2018. This alarming statistic reflects the harsh reality that pharmacies, and their ePHI, are targets for criminals. Pharmacies are directly in the crosshairs of malicious actors and pharmacy owners [and employees] must take steps to safeguard their data. Not only is it the law, but it is your data, reputation, time and money on the line!

PAAS Tips:

  • Develop and implement policies and procedures to safeguard ePHI
    • For 15 years, PAAS FWA/HIPAA compliance program has been helping community pharmacies be compliant. Had HVHS implemented PAAS’ program, they would have not had the resulting non-compliance issues and resulting fines.
  • Ensure all staff handling ePHI receive training on a regular basis to understand their role in protecting ePHI and the implications of non-compliance, as well as intentional misuse (i.e., breach, fines, exclusion from Medicare/Medicaid, imprisonment, etc.)
  • At least once a year, the Security Officer should perform a thorough assessment of the potential threats, vulnerabilities and the associated risks to the confidentiality, integrity and availability of ePHI
  • PAAS’ FWA/HIPAA Compliance Program members can update their HIPAA Risk Analysis, complete HIPAA training and Cybersecurity training on the PAAS Portal

Are PBM Regulations Being Enforced by Your State? Let Your Voice Be Heard!

When PBMs violate state law, pharmacies need to scream from the mountain tops. Get the ball rolling by filing a complaint with your state regulators. As a local state representative said, “If there are no complaints, then we assume all of the regulations put forth are working great”. If you’re not sure where to start, the National Community Pharmacists Association’s (NCPA) has a webpage that provides instructions on how to file a complaint in your state.

Over the past several years, nearly every state has passed some type of PBM reform. While there have been great strides with comprehensive regulations, and court victories, this can be diminished if no complaints are reported [when laws are violated] and states are not held accountable for enforcing the laws being put in place.

You must be proactive and hold your state agency’s feet to the fire. You do that by filing complaints when the insurers/PBMs are NOT following the law. It surely does not shock any community pharmacy that PBMs willing violate these laws. The more detailed, factual-based complaints regulators receive, the more likely they are to investigate and ENFORCE the law.

Not only does failing to report violations undermine the effort that went into getting the law passed, but it also makes future PBM reform more difficult. With minimal complaints on record, legislators (and PBM lobbyists) may use that as rationale not to take up additional reform (i.e., the existing regulations are effective).   

Some of the common complaints with audits are:

  • Failure to adhere to audit timelines or limitations
  • Identifying audits as FWA or ‘investigational’ seemingly only to avoid state audit parameters
  • Auditors refusing to accept documentation
  • Inconsistent application of audit rules and guidelines
  • Recoupments for technical discrepancies

Pharmacies are often fearful of filing complaints due to the potential for PBM retaliation. Consequently, many states have included non-retaliation language in the reform. While it can understandably give pharmacy owners pause, if you’re not willing to stand up for your pharmacy, who will?

PAAS Tips:

  • Be familiar with your state PBM regulations
  • If you feel state laws have been violated – file a complaint
    • Unsure of whether an audit situation is complaint worthy? Talk with PAAS
    • Provide all necessary documentation to support (and explain) your dispute
    • Maintain thorough documentation of all pharmacy transactions and interactions relevant to the situation

PBM Audits on Ozempic®: 5 Common Discrepancies Revealed

Popularity for GLP-1 medications, like Ozempic®, continues to grow and, consequently, PAAS National® encounters these drugs on PBM audits frequently. This article outlines five common discrepancies observed in audit findings for Ozempic®.

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

PAAS Tips:


Audit Risk: Prescriber Scope of Practice and Treating Self or Family

Everyone knows that PBMs do not perform “random” audits, nor do they select “random” claims in these audits. PBMs have sophisticated algorithms to look at thousands (if not millions) of prescription claims to find abnormalities and patterns that may be indicators of fraud, waste, or abuse. Two of the not-so-sophisticated formulas include comparing prescriber specialty to the drugs prescribed and matching last names of prescriber and patient.

In addition to having PBM audit risk …

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prescriptions written by prescribers that are outside of their designated specialty, or to treat themselves or family members, pose numerous ethical, legal and professional dilemmas and must be managed carefully. These situations may occur more frequently in small towns where there are limited prescribers.

While most states allow prescribers to write prescriptions beyond their specialty and to treat themselves or family members with non-controlled medications – the boundaries of when it is appropriate rely on professional judgement and opinions of both the prescriber who writes the prescription and the pharmacist who receives it.

The American Medical Association (AMA) states that, in general, physicians should not treat themselves or members of their own families. However, the AMA recognizes that it may be acceptable in limited circumstances such as emergency situations when no other qualified physician is available or for short-term, minor problems. The AMA outlines some of the possible concerns about professional objectivity, patient autonomy, and informed consent in its policy opinion.

When the patient is an immediate family member, the physician’s personal feelings may unduly influence his or her professional medical judgment. Or the physician may fail to probe sensitive areas when taking the medical history or to perform intimate parts of the physical examination. Physicians may feel obligated to provide care for family members despite feeling uncomfortable doing so. They may also be inclined to treat problems that are beyond their expertise or training.

Similarly, patients may feel uncomfortable receiving care from a family member. A patient may be reluctant to disclose sensitive information or undergo an intimate examination when the physician is an immediate family member. This discomfort may particularly be the case when the patient is a minor child, who may not feel free to refuse care from a parent.

PAAS Tips:

  • Most states prohibit prescribers from writing controlled substances for themselves and family members, except in emergencies.
  • Prescriptions written outside of a prescriber’s specialty pose potential risk of inappropriate or ineffective treatment due to a lack of expertise.
  • Documenting your rationale when choosing to dispense (or not to dispense) these types of prescriptions may protect you from PBM entanglements.
  • Best practices to help pharmacies navigate these complex situations:
    • Evaluate each prescription individually – take into account the diagnosis, the medication, and the availability (or lack thereof) of alternative prescribers
    • Verify your state laws with respect to non-controlled medications (self-prescribing of controlled substances is generally prohibited)
    • Have clear communication with patient and prescriber about your concerns
    • Document any communications with patient and/or prescriber on the prescription or in your pharmacy management system (helpful whether you choose to fill or not fill the prescription).
    • Coordinate alternative treatment options with patient and prescriber (if you choose to not dispense)

Nondiscrimination in Health Programs and Activities – Cultural Competency Training is a Must!

Earlier this year the Office for Civil Rights (OCR) released the 2024 Final Rule under Section 1557 of the Affordable Care Act (ACA), reestablishing many of the 2020 Finale Rule protections that were removed by the prior administration. One of the noteworthy changes (or reinstated regulations) appears in 45 CFR 92.11, which requires covered entities who receive federal funding to let patients know that language assistance services and auxiliary aids and services are available if needed. The notice is to be provided in English plus at least the 15 most common languages spoken by individuals with limited English proficiency (LEP) in the United States. In addition, the notice should be provided via alternate formats for those individuals with disabilities that require auxiliary aids in order to provide equal access to services rendered by covered entities. Despite this seemingly large undertaking, OCR is giving covered entities until July 5th, 2025 to implement this requirement plus is providing sample “Notice of Availability of Language Assistance Services and Auxiliary Aids and Services” that have already been translated.

The notice is but a fraction of the overarching theme the 2024 Final Rule carries: inequality of services provided amongst federally-funded programs is not tolerated. Covered entities must urgently become mindful of their Section 1557 obligation of providing non-discriminatory services on the basis of race, color, national origin, sex, age, or disability as this has been enforced since its inception in 2020, primarily by OCR receiving and investigating discrimination grievances.

Although it may seem as though the likelihood of being in OCR’s crosshairs for a Section 1557 violation is low, by the time covered entities receive notice of an investigation for discriminatory actions, it is too late. Be proactive with Cultural Competency training to help avoid an investigation in the first place, and demonstrate that your pharmacy is making strides to provide equivalent access to care.

Pharmacies that complete cultural competency training, and have the training documented, should ensure their NCPDP profile reflects that training. Learn more about PAAS’ Cultural Competency Training here, or contact us today to add the training to your membership.

2024 National Health Care Fraud Takedown

On June 27th the U.S. Department of Justice (DOJ) issued a press release outlining a National Health Care Fraud Enforcement Action that resulted in 193 defendants charged, including doctors, nurses and pharmacists, and over $2.75 billion in false claims. This year marked the highest numbers since 2020 and included coordinated efforts by the DOJ, US attorneys’ offices, HHS Office of Inspector General, FBI, and the DEA.

Takedowns related to prescription drugs included:

  • Illegitimate distribution of Adderall® and other controlled substance stimulants via telemedicine
  • Distribution of diverted HIV medications through gray market wholesalers
  • Medically unnecessary prescriptions for compounds and foot baths
  • Submission of claims to federal payors for drugs that were not purchased or dispensed
  • Providing kickbacks to patients to fill medically unnecessary prescriptions
  • Bribing physicians with cash and entertainment to refer prescriptions

For 15 years, PAAS National®’s FWA/HIPAA compliance program has helped educate community pharmacies on federal regulations. Coupled with audit assistance and the Newsline, PAAS serves as a guiding light, steering pharmacies away from trouble and towards compliance. The FWA program not only meets CMS’ definition (and PBM requirements) of an effective compliance program, but also helps with written Policies and Procedure for credentialing.

PAAS Tips:

For more insight into these compliance issues, PAAS Audit Assistance members can consider reading the following articles (many more articles available on our eNewsline):

The Need for Clarification on Prescription Labels

Pharmacy staff frequently receive prescriptions from prescribers that lack (or are missing) complete quantities or instructions for use. Clarifying these details before dispensing can help prevent audit discrepancies. Pharmacies must document these clarifications made with the prescriber’s office utilizing a clinical note that contains all four essential elements:

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  1. Date/time of clarification
  2. Name and title of who you spoke with
  3. What information was clarified
  4. Initials of pharmacy staff that made the call

This proactive approach not only enhances accuracy but also mitigates audit risk.

PBMs like OptumRx® and Caremark® are very particular that any clarification relating to instructions for use be included on the patient’s label. Auditors that determine information is missing from the patient label have flagged these as “misfilled” prescriptions – which can be very difficult to overturn. Pharmacy staff must be diligent in updating patient labels to include any supplemental instructions that were clarified.

Additionally, OptumRx® has been flagging prescriptions that include a numeric value at the end of the instructions. Some e-prescribing systems will drop the days’ supply value at the end of the instructions for use (e.g., Take 1 tablet daily. 90). Auditors claim they cannot accurately calculate the days’ supply based off “unclear information included in the instructions”. As time consuming (and absurd) as it may seem, auditors will only be satisfied if the pharmacy took the time to contact the prescriber’s office to clarify the directions and remove the erroneous days’ supply number at the end of the directions.

PAAS National® analysts frequently see the following items flagged on audit when the clarifying clinical note does not make it on the patient label:

  • Max daily dose for insulin prescriptions with sliding scale or titration
  • Area of use for topical medications or max number of grams per application
  • Number of meals and snacks for pancreatic enzyme prescriptions

PAAS also sees issues where the backtag or label do not reflect the entire instructions for use due to an expanded sig and limit of characters being printed.

PAAS Tips:

  • Ensure all staff know the four elements of a clinical notation
  • Clarification of instructions for use MUST be reflected on the patient label
  • Be sure clinical notations are included on the prescription, or electronic notations provided to the auditor for review
  • Self-audit prescriptions frequently to ensure patient labels include supplemental information clarified

Liraglutide Injection Marks Debut as First Authorized Generic GLP-1 Product

In late June, Teva Pharmaceuticals launched the first “generic” GLP-1 (Glucagon-Like-Peptide-1) receptor agonist in the United States, known as Liraglutide injection (6 mg/mL). This authorized generic of Victoza® is a once daily noninsulin injection approved to treat type 2 diabetes in adults and children aged 10 and older. It is also approved to reduce the risk of cardiovascular events like heart attacks and stroke in adults with type 2 diabetes and heart disease.

The FDA defines an authorized generic (AG) drug as the brand name drug that is marketed without the brand name on its label. So other than not having Victoza® on the label, Liraglutide is the exact same drug product as the brand Victoza®. An AG may be marketed by the brand name drug company or another company with the brand’s permission. While it is the same as the brand name product, companies typically choose to sell the AG at a slightly lower cost than the brand.

PAAS Tips:

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  • An AG is therapeutically equivalent to its brand name drug because it is the same drug
  • An AG is marketed under the brand name drug’s NDA (New Drug Application), therefore it is not listed in the FDA Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book)
  • A pharmacy can substituted an AG for the brand name without the prescriber’s approval or a new prescription
  • Be alert that GLP-1 medications (originally approved to treat diabetes) are also FDA approved, marketed and prescribed for obesity under a different Trade Name and NDA
    • Saxenda® (Liraglutide) is FDA approved for obesity
    • AG Liraglutide injection is only approved to treat type 2 diabetes in adults and children aged 10 and older

2024 DMEPOS Series #6: Immunosuppressive Drugs for Transplant

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.

Specifically, you need to demonstrate the following in case of an audit regarding immunosuppressive drugs for transplant:

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  • Standard Written Order (SWO)
  • Medical Records
    • Type of transplant must be documented (see documentation checklists in PAAS tips for full list)
    • The drugs prescribed following the transplant
    • Date and location where transplant was performed (in a Medicare approved facility)
  • Proof of Delivery
  • Proof of Refill Request and Affirmative Response
    • Required if delivered or mailed

Coverage criteria for immunosuppressive therapy:

  • The beneficiary was enrolled in Medicare Part A at the time of the transplant.
  • The beneficiary was enrolled in Medicare Part B at the time the drugs are dispensed.
  • The drugs were furnished on or after the date of discharge from the hospital following a covered organ transplant.
    • For date of service (DOS) on or after April 3, 2019 mail-order deliveries of immunosuppressive drugs may be mailed one or two days prior to a beneficiary’s anticipated date of discharge from an inpatient facility to a qualified place of service or alternate address, such as the inpatient hospital that performed the transplant or alternative location where the beneficiary is temporarily staying (such as temporary housing). The DOS on the claim must be the date of discharge.
  • The transplant was performed at a Medicare-approved facility.
  • The dosage, frequency and route of administration conform to generally accepted medical practice and is medically necessary to prevent or treat the rejection of an organ transplant.
  • If the prescribed drug is parenteral azathioprine (J7501) or methylprednisolone (J2920, J2930), medical records confirm that the medication cannot be tolerated or absorbed if taken orally and is being self-administered by the beneficiary.

PAAS Tips:

  • Immunosuppressive drugs are only covered under Part B to maintain an organ transplant that was Medicare eligible
  • The quantity of immunosuppressive drugs dispensed is limited to a 30-day supply
  • The KX modifier must be added to the claim line(s) for the immunosuppressive drug(s) only if all of the following four requirements are met:
    • The supplier has obtained from the ordering treating practitioner the specific date of the organ transplant, and
    • The supplier is retaining this documentation of the transplant in its files, and
    • The beneficiary was enrolled in Medicare Part A, at the time of the organ transplant (whether or not Medicare paid for the transplant), and
    • The transplant date precedes the date of service on the claim
  • If all coverage criteria are not met, the GY modifier must be added to the claim line(s)
  • The diagnosis code(s) that justify the need for these items must be included on the claim
  • Download PAAS’ Proof of Refill Request and Affirmative Response form under Proactive Tips on the Member Portal where you can document the required information from the beneficiary or their caregiver if the prescription is being mailed or delivered
  • Review documentation checklist for Jurisdiction A and D
  • Review documentation checklist for Jurisdiction B and C
  • Review the Immunosuppressive Drugs LCD and Policy Article
  • Review the following Newsline articles for additional information:

PAAS Audit Assistance members can 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 at (608) 873-1342 or info@paasnational.com and our staff can assist you.