OTC COVID-19 Test Prescribing Authority

Some pharmacies are wondering if they are allowed to continue prescribing OTC COVID-19 tests. The eleventh amendment to the Public Readiness and Emergency Preparedness Act (PREP Act) was issued on May 12, 2023 and extends PREP Act coverage through December 31, 2024 to allow licensed pharmacists to order and administer COVID-19 countermeasures including COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests.

Coverage for OTC COVID-19 tests varies by payer. See summary below:

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  • Medicare Part B coverage ceased as of May 12, 2023
  • Medicare Advantage plans may cover and pay for OTC COVID-19 tests as an added benefit
  • Medicaid coverage should continue through September 30, 2024
  • Commercial insurance coverage will vary; however, plans are not required to cover after May 11, 2023

PAAS Tips:

  • The eleventh amendment to PREP Act extends pharmacist prescribing authority through end of 2024
  • Point-of-sale edits should be relied upon to understand if OTC product is covered
  • Only dispense OTC COVID-19 tests upon patient request – do not autofill
  • Ensure you retain documentation of patient request using PAAS’ Attestation form

PAAS Battles MedImpact for DAW 0 Reimbursement on Semglee®

MedImpact sent a memo to network pharmacies dated May 22, 2023, with the subject line Semglee-YFGN (Preferred U-100 Long Acting Insulin). For their participating Medicare Part D plans, MedImpact requested pharmacies to dispense Semglee® (YFGN) at the brand reimbursement. Other insulin glargine products were considered non-formulary with a claim rejection response. The memo goes on to indicate that this ‘brand’ claim must be submitted with a DAW of 9 to get correctly reimbursed, meaning pharmacies that use a default DAW 0 could be incorrectly paid!

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Over the past several months, PAAS National® has been chiding the MedImpact Clinical Services team about this reimbursement decision and the correct biosimilar terminology and DAW utilization.

As pharmacies may be aware, Semglee® (YFGN) is not a brand, but an interchangeable biosimilar. As such, it does not require a DAW code and requiring a DAW 9 for Semglee® (YFGN) would be incorrect according to NCPDP guidance.

NCPDP description of a DAW 0:

This is the field default value that is appropriately used for prescriptions for single source brand, single biologic, cobranded/co-licensed, generic or interchangeable biosimilar products. DAW 0 is not appropriate for a multi-source branded product with available generic(s) or for a reference product with interchangeable biosimilar(s).

NCPDP description of a DAW 9:

This value is used when the prescriber has indicated, in a manner specified by prevailing law, that generic or interchangeable biosimilar substitution is permitted, but the plan’s formulary requests the brand or reference product. This situation can occur when the prescriber writes the prescription using either the brand, reference product, generic or interchangeable biosimilar name and the product is available from multiple sources.

While MedImpact considers Semglee® (YFGN) a brand for reimbursement purposes, it is classified by the FDA as an interchangeable biosimilar. The DAW code definitions (pasted above) from NCPDP state that DAW 0 would be appropriate. Pharmacies should not be negatively impacted financially for failing to use the DAW 9 code. This is not consistent with the industry and is an inappropriate use of DAW 9. DAW 9 states that an interchangeable biosimilar is permitted, but the Plan wants a brand or reference product. Semglee® is not a reference product in this definition (in reference to biologic drugs), Lantus would be.

After months of back and forth, PAAS was just informed by MedImpact that at the end of August, the POS message referencing DAW 9 for Semglee® (YFGN) was removed from all 2023 and 2024 Part D formularies. They are removing all messaging related to DAW 9 for insulin glargine and referencing “Please Dispense Brand for Generic Copay” with no requirement for a DAW 9 reference.

Your membership in PAAS helps us continue to advocate and fight for fair treatment of independent pharmacies.

Use As Directed – What is Your Attack Plan?

The top audit discrepancy year after year is invalid days’ supply or refill too soon – which are essentially the same issue. Submitting prescription claims with an accurate days’ supply is often the responsibility of a pharmacy technician doing data entry, while pharmacists are focused on clinical accuracy and may not be paying attention to this “clerical” issue. It is important that all pharmacy staff members (technicians and pharmacists) understand the audit implications of submitting an incorrect days’ supply and how each staff member can contribute to success. With that in mind, the pharmacy team can develop an attack plan to be both accurate and consistent.

First, understand …

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that the submission of an accurate days’ supply is important for appropriate claims adjudication and impacts patient copay, pharmacy reimbursement, and PBM refill edits. While PBMs require pharmacies to submit an accurate days’ supply, it may be helpful to think of these implications – knowing why helps pharmacy staff understand the importance and may help justify spending the extra time (where appropriate).

Second, staff must be trained how to perform the mathematical calculations. How would your staff estimate the days’ supply for an insulin or topical cream prescription with a sig of “use as directed”? If each staff member gives you a different answer, then you have an audit problem waiting to happen. In general, days’ supply is simply the total quantity dispensed divided by the daily (or weekly, monthly) dose. Data entry staff should perform the calculations and document, while dispensing technicians and/or verifying pharmacists can double check those calculations for accuracy.

Third, you must have a plan for how to address certain dosage forms where the basic calculation does not come so easily. Common examples include topical creams, vaginal creams, insulin, diabetic test strips, bowel prep kits, migraine meds, starter kits and pancreatic enzymes.

  • If a prescription sig reads “use as directed”, then you don’t have enough information and must contact the prescriber’s office for more information and make a clinical note
  • If a days’ supply is not calculable, consider a maximum daily dose for insulin, test strips and pancreatic enzymes
  • Migraine meds may require an estimated number of headaches per month
  • Starter kits should be confirmed “as directed on package”
  • Confirm dosing for bowel prep kits – remember products generally have a beyond use date of 48 hours upon reconstitution
  • Use the manufacturer dosing calculator for Santyl
  • Leverage PAAS’ days’ supply charts available on the PAAS Portal for insulin, topicals, eye drops, nasal inhalers and oral inhalers

PBM auditors will expect that any clarifications regarding instructions for use end up on the dispensing label to communicate instructions to patients – see this month’s article Auditor’s Latest Trick for Flagging “Misfilled” Prescriptions.

PAAS Tips:

  • Do not rely on the days’ supply field on e-prescriptions alone as it is often incorrect and would not satisfy an auditor (you might even consider the pros versus cons of having e-prescription days’ supply field auto-populate)
  • Make sure that dispensing technicians and verifying pharmacists can “see” the days’ supply during verification, whether performing on screen or reviewing printed “back tags”
  • Consider performing small “self-audits” to spot check your team for accuracy and consistency
  • If you cannot mathematically estimate the days’ supply (with an equation), then an auditor will consider the prescription to be essentially “use as directed” and require more information

$32 Million Kickback Scheme Involving Medicare and TRICARE

According to an August 18, 2023 press release from the U.S. Attorney’s Office, District of New Jersey, a former president of a pharmacy business pleaded guilty to a scheme that violated the Federal Anti-Kickback statute. For a little over 3 years, this individual engaged in fraudulent activity by paying marketing companies to direct prescriptions for expensive medications with high reimbursement to his pharmacies. The marketing companies would identify Medicare and TRICARE beneficiaries and convince them over a recorded phone call to try expensive creams and migraine medications. Then they forwarded these recorded phone calls with a pre-printed prescription pad for the medications with high margins to telemedicine companies. For every beneficiary referred for a prescription, the marketing company would provide a kickback and the telemedicine company would pay the doctors to approve the prescriptions. These prescriptions were then filled at the pharmacies in which they had a kickback agreement. The pharmacies received payment and sent part of each reimbursement to the marketing companies as a kickback. This scheme caused a loss of over $32 million dollars billed to Medicare, TRICARE, and other federal health benefit programs. This violation of the Anti-Kickback Statute has a potential penalty of five years in prison and a maximum fine of $250,000, or twice the gross gain or loss that occurred, whichever is greatest.

Ensure your pharmacy has a robust Fraud, Waste, and Abuse Compliance Program in place for employees to understand the repercussions of violating laws and regulations such as the False Claims Act and the Anti-Kickback laws. Contact PAAS National® for more information on our comprehensive program that is easy to set-up, web based and customized for your pharmacy.

PAAS National® Announces USP 800 Compliance Program

PAAS National® is excited to announce the USP 800 Compliance Program for community pharmacies. Developed by community pharmacists, PAAS brings you a community pharmacy tailored approach to USP 800 operational needs.

“Empowering community pharmacies with best-in-class, web-based programs to ensure employee safety and maintain pharmaceutical standards are at the forefront of our priorities. Compliance with USP 800 reinforces our commitment to community pharmacies in reducing their liability while improving patient safety and upholding the highest industry standards in handling hazardous drugs,” stated Carmen Fusselman, Vice President at PAAS National®. “PAAS will provide you with the information necessary to implement a fully functional USP 800 Compliance Program with the least necessary interruption to your day-to-day business.”

The PAAS USP 800 Compliance Program will reduce a pharmacy’s exposure to hazardous drugs through physical processes, written policies and training to ensure compliance with USP 800.

If you would like more information about PAAS USP 800 Compliance Program, please visit paasnational.com/usp800 or contact PAAS National® at (608) 873-1342 or info@paasnational.com.

Breyna™ – The First FDA Approved Symbicort® Generic With a 0.1 Gram Problem

Breyna™, like Symbicort® is approved as a maintenance therapy for people with COPD and for asthma patients ages 6 and older. For Breyna™ to become a regular generic, the manufacturer (Viatris) had to submit an Abbreviated New Drug Application (ANDA) to the FDA. Viatris had to prove that Breyna™ is comparable to Symbicort® in dosage form, strength, route, quality, performance characteristics, and intended use. Below is a chart comparing Symbicort®, its authorized generic and the new “regular” generic Breyna™ (also known as an ANDA generic).

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Product NDC Labeler FDA Application Number Package

Size (gm)

 Source
Symbicort® 80-4.5 MCG 00186-0372-20 AstraZeneca 021929 10.2 Brand
Budesonide-Formoterol Fumarate 80-4.5 MCG 00310-7372-20 Prasco 021929 10.2 Authorized Generic
Breyna™ 80-4.5 MCG 00378-7502-32 Mylan 211699 10.3 ANDA Generic
Symbicort® 160-4.5 MCG 00186-0370-20 AstraZeneca 021929 10.2 Brand
Budesonide-Formoterol Fumarate 160-4.5 MCG 00310-7370-20 Prasco 021929 10.2 Authorized Generic
Breyna™ 160-4.5 MCG 00378-7503-32 Mylan 211699 10.3 ANDA Generic

PAAS Tips:

  • The Breyna™ inhaler comes in a package size of 10.3 gm, which is different than Symbicort® and its authorized generic that come in a package size of 10.2 gm
    • PAAS would recommend the pharmacy obtain a new prescription for Breyna™ due to the different package sizing. If a prescriber writes for Symbicort® 10.2 gm, one inhaler with 5 refills, a total of 61.2 gm was authorized. If a pharmacy bills and dispenses all 6 fills using the Breyna™ NDC, this would be 61.8 gm total. If audited, a PBM could recoup the last claim due to dispensing an overbilled quantity that was not authorized.
  • See our updated Inhaler Chart on the PAAS Portal
  • What is an Authorized Generic?
    • An authorized generic is the exact same drug product as the brand, including both active and inactive ingredients
    • It is often made in the same facility and on the same equipment as the brand with the generic name on the label instead of the brand name, and sold at a lower price
    • Note that the FDA approval numbers are the same for the brand and the authorized generic
    • Considered to be therapeutically equivalent to its brand-name drug because it is the same drug
  • What is a Regular Generic (ANDA)?
    • An ANDA generic is the same brand-name drug in active ingredients, conditions of use, dosage form, strength, route and for the most part labeling, but may have certain minor differences such as inactive ingredients
    • Typically developed and made by a company other than the company that makes the brand-name drug.
    • Has a different FDA application number than the brand name and authorized generic
    • Must confirm bioequivalence to the brand name
  • See the FDA website for additional discussion on Authorized Generics

Signature Required – Proving Patient Receipt

The Public Health Emergency for COVID-19 ended on May 11, 2023, and PBMs notified pharmacies that they would once again be requiring signatures for proof of patient receipt of medications. Since then, PAAS National® analysts have taken questions about what format signatures logs should take. The following tips should help your pharmacy stay compliant.

PAAS Tips:

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  • Point of sale electronic signature logs should contain:
    • Prescription number
    • Date filled or fill number
    • Date of pick-up
    • Signature of the patient or the representative who picked-up the medication for the patient
  • Delivery logs should contain:
    • Patient name
    • Prescription number
    • Date filled or fill number
    • Date delivered – cannot be pre-printed
    • Delivery address – pharmacy, patient, or facility
    • Signature of the patient or the representative who accepted the delivery
  • Check your delivery logs for a blank date field (i.e., not pre-populated) and consult with your software vendor to add a signature date field (or electronic date stamp), if needed
  • Consider using the PAAS National® Trifold Mailer if unable to get a patient signature upon delivery
  • Pharmacies using manual signature logs should consider downloading and printing the PAAS National® Signature Log Book from the “Forms” tab on the PAAS Member Portal
  • Pharmacies mailing prescriptions have additional requirements to prove receipt
  • Be aware of PBM return to stock policies by using the PAAS National® Return to Stock chart

Recent DEA Rule Change – Transferring Electronic Prescriptions for Controlled Substances for Initial Fill

The DEA published a couple rule changes recently which pharmacies need to be aware of. In the September 2023 Newsline, the updated rule regarding partial fills for controlled substances was discussed. The other recent change published in the Federal Register was titled, Transfer of Electronic Prescription for Schedules II-V Controlled Substances Between Pharmacies for Initial Filling. This rule went into effect August 28, 2023, and clarified the DEA’s previous rule on the transferring of controlled substances. Pursuant to 21 CFR § 1306.08, Electronically Prescribed Controlled Substances (EPCS) can be transferred for initial filling on a one-time basis, upon the request of the patient and all authorized refills on C-III, C-IV and C-V prescriptions are transferred along with the original prescription. All the following additional requirements must also be met:

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  1. The transfer must be communicated directly between two licensed pharmacists, which includes any person (e.g., pharmacist intern) who is authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.
  2. The prescription must remain in its electronic form with no intermediary conversion to another form (e.g., facsimile).
  3. The contents of the prescription required by 21 CFR part 1306 must be unaltered during the transmission. Any change to the data, including truncation or removal of data, will invalidate the prescription.
  4. The transfer for EPCS for initial dispensing is permissible only if allowable under existing State or other applicable law.

According to the Federal Register notice, NCPDP confirmed SCRIPT Standard Version 20177071 had the appropriate functionality to allow the electronic transfer of an EPCS. Since this SCRIPT Standard is widely used among software vendors for chain and independent pharmacies, the capability to electronically transfer these prescriptions should be available; however, pharmacies may need to talk with their vendors about activating this functionality.

When a patient requests the transfer, the receiving pharmacy must initiate the process by electronically requesting the transfer. The “transferring pharmacy” must update their records to show the prescription was transferred out and include:

  • Name, address, and DEA number of the receiving pharmacy.
  • Names of the transferring and receiving pharmacists.
  • Date of the transfer.
  • Note: The transferring pharmacy is not responsible for maintaining proof of the patient’s request to transfer the prescription.

The “receiving pharmacy” must document:

  • The word “transfer” in the electronic prescription file.
  • Name, address, and DEA number of the transferring pharmacy.
  • Names of the transferring and receiving pharmacists.
  • Date of the transfer.

The software system may pre-populate the data entry fields if the pharmacist verifies the accuracy of the information.

PAAS Tips:

  • If a paper prescription for a controlled substance is presented to the pharmacy and the pharmacy is unable to fill it, give the prescription back to the patient to take elsewhere (remember to keep a copy of the prescription and the reversed claim on file in the event of an audit to prevent accusations of phantom claims)
  • Remember to maintain all documentation related to the transfer for a minimum of two years from the date of the transfer per Federal law; longer if dictated by State law, Medicare Part D or PBM contract requirements
  • Do not partial fill a controlled substance, then transfer the remaining quantity on the prescription to another pharmacy to dispense the rest of the partial fill because there is currently no law which allows this practice; pharmacies may only transfer the whole prescription for the initial fill pursuant to 21 CFR 1306.08 or transfer a C-III, C-IV or C-V (paper, oral, or electronic) prescription to another pharmacy for the purpose of refill dispensing pursuant to 21 CFR § 1306.25

[FREE PAAS Webinar] Awareness to Action: Initiating USP 800 Compliance in Community Pharmacies

Join Vice President of PAAS National®, Carmen Fusselman, PharmD as she discusses:

  • Why your pharmacy needs a USP 800 Compliance Program for handling hazardous drugs
  • Requirements of USP 800 compliance program in community pharmacy
  • Implementing a fully functional program with the least interruption to your day-to-day business

We will allow for some Q&A at the end of the webinar. If you would like to submit questions prior to the webinar, please click here.

PAAS Audit Assistance members will have access to a recording on the PAAS Member Portal if they are unable to attend the live event.

Register Today!

Auditors’ Latest Trick for Flagging “Misfilled” Prescriptions

PAAS National® analysts are noticing more prescriptions being flagged for recoupment based on “incorrect” instructions for use on the patient label. Pharmacies and PBM auditors have very different perspectives on what a “misfilled” prescription is. PBMs will look to categorize a claim as a “misfill” if the directions on the patient label do not include all instructions (including any clarifications made with prescriber). Appealing these discrepancies successfully can be a fruitless endeavor, predicated on circumstances and PBM guidelines.

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OptumRx discrepancy is listed as 3H-Directions on prescription different from computer records. No post-dispensing validation accepted. No verbal orders/annotations accepted.

Caremark discrepancy is listed as MIF-Prescription dispensed was filled with incorrect drug, strength, directions or patient. This discrepancy does not require further documentation.

Pharmacies are often very familiar with prescribers and what they may intend to include on the prescription but don’t. This can range from a clear quantity to actual instructions for the patient. Unfortunately, pharmacies supplementing or documenting clinical notations that do not make it on to the patient’s prescription label can face recoupment as a “misfilled” prescription.

Some of the common examples PAAS analysts see are when information was clarified or confirmed with the prescriber and added to the prescription but not included on the patient label:

  • Max daily dose for insulin with sliding scale or titration
  • Number of snack and/meals for pancreatic enzymes
  • Grams per application or area applied for topical medications

Additionally, PAAS is seeing issues where the pharmacy’s backtag and label do not include the entire set of instructions (i.e., an extended sig/label). Many software vendors only allow so many characters in the instruction field and may require additional instructions to be entered/printed separately. Not providing all the instructions the patient received [upon audit] would likely result in the claim being flagged for recoupment.

PAAS Tips:

  • Verifying information with the prescriber prior to dispensing
  • Clinical notes to document clarifications should include 4 elements
    • Date/time
    • Name and title of who you speak with
    • Summary of discussion
    • Pharmacy staff initials
  • Educate all data entry staff to include information on patient label that is related to the instructions for use
  • When submitting documentation for audit, be sure the auditor is receiving all information