PHE for COVID-19 Ending May 11, 2023: Pharmacy and Audit Ramifications

On January 30, 2023, President Biden’s administration announced that both the national emergency and public health emergency (PHE) for COVID-19 would be ending on May 11, 2023. This will have far-reaching implications for everyone in healthcare, including pharmacy.

Audits

While the PBMs took a break from auditing pharmacies in the early days of the pandemic, most gradually started up again by the end of 2020. They started with desk audits and slowly added back in larger virtual audits to take the place of the onsite audits. Most recently, PBMs have reinstated onsite audits. If you feel like you have been seeing more audits, it is likely because you are.

  • January 2023, PAAS helped with 969 audits. A 30% increase year over year!

PBMs also made concessions in other audit areas due to the COVID-19 pandemic, including relaxed restrictions on mailing and delivery to patients during the PHE. They also made concessions allowing pharmacies to dispense prescriptions without obtaining a signature from the patient. While some PBMs and payors have already reinstated signature requirements, PAAS National® expects both of these situations to return to pre-pandemic requirements no later than May 11, 2023.

PREP Act

Some Public Health and Emergency Preparedness (PREP) Act authorities will end May 11, 2023, unless made permanent through state legislation. Check with your Board of Pharmacy and/or state pharmacy association to see what will still be allowed in your state. Requirements relevant to pharmacies that will be ending include coverage with no cost share for at-home COVID-19 tests/testing related-services for patients with Medicare, Medicare Advantage, and commercial insurance. Commercial insurers will also no longer be required to cover eight OTC tests per month. Health plans will no longer be required to reimburse out-of-network providers for tests/testing-related services, or cover vaccines for COVID-19 without cost-sharing when provided by out-of-network providers. They will also no longer be required to reimburse these vaccines at a “reasonable” rate.

It is difficult to know how the different health plans will handle these changes. Patients have grown accustomed to not paying any cost-share amount for these items. Adding cost-share may add to vaccine hesitancy concerns or hinder a patient’s ability to continue receiving COVID-19 vaccines and tests. Pharmacies will be on the front lines again helping patients navigate changing coverages.

PAAS Tips:

  • We recommend pharmacies start collecting signatures from patients for prescription pick-ups on or before May 11, 2023, if you have not already.
  • PAAS Audit Assistance members can review the February 2023 Newsline article, Are Your Delivery/Signature Logs PBM Compliant for 2023?
  • Check your state’s legislation to see what PREP Act authorities have been made permanent in your state.

Levemir® FlexPen® is Replacing the Levemir® FlexTouch®

Novo Nordisk® discontinued manufacturing the Levemir® FlexTouch® in early February 2023. The FlexTouch® will be distributed until stock is depleted and is being replaced with the FlexPen®. Please see the charts below for changes between the FlexTouch® and the FlexPen®.

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Levemir® FlexTouch® New! Levemir® FlexPen®
Changes
NDC 00169-6438-10 00169-6432-10
Pen Needle NovoFine® or NovoTwist® NovoFine® or NovoFine® Plus
Max # of units per single injection Up to 80 units Up to 60 units
Remains the Same
Type of Insulin Insulin detemir Insulin detemir
Manufactured 3 mL single patient use prefilled pen 3 mL single patient use prefilled pen
Unbreakable package size 5 x 3 mL pens 5 x 3 mL pens
How units are dialed Dialed in 1-unit increments Dialed in 1-unit increments
AWP $554.65 $554.65
# of units needed to prime each pen prior to use 2 units 2 units

PAAS Tips:

  • Due to the different features and functions on how to use
    • Review the new instructions for the Levemir FlexPen®
    • Get an updated prescription to minimize disruption to patient care

To Sign, or Not to Sign, the OptumRx® Recoupment Waiver … That Is the Question

If your pharmacy has recently been through an OptumRx® desk audit, you may have come across the OptumRx Provider Intent Form – Recoupment Waiver. This one-page form accompanies initial audit results and if signed, gives OptumRx® even greater power over the pharmacy. A signature on the form indicates the following:

There is no apparent benefit to the pharmacy by signing this form. Additionally, signing and agreeing to the preliminary audit findings could be construed as the pharmacy’s admission of wrongdoing. Only OptumRx® would benefit from this waiver and PAAS National® does not feel it is in the best interest of pharmacies to sign.

If you have additional questions or concerns regarding audit preparation, the audit appeal process, or safe billing and filling strategies, the PAAS team is here to guide you. Give us a call (608) 873-1342, email info@paasnational.com or submit a question online through the PAAS Member Portal.

First Step in Getting Help with an Audit

Oh no! You just received an audit, now what? Your first step is to get the audit notice to PAAS National® – the sooner that we are part of your team, the more benefit we can bring. Our all-inclusive membership means there are no hidden fees or limits to the audit assistance you can receive.

Make PAAS part of your audit process, every time. Review the 4 Steps to Using your PAAS Audit Assistance on the PAAS Member Portal for audit assistance members under Proactive Tips.

One of the best ways to get started is to create a workflow process when audits are received. Too many dollars are lost to PBMs due to missed deadlines or incomplete documentation – don’t let this happen to you. By putting a few simple steps in place, you can avoid costly mistakes in the future.

PAAS Tips:

Are Your Delivery/Signature Logs PBM Compliant for 2023?

A common component of a pharmacy audit request is the delivery/signature log. Delivery/signature logs are used to prove the patient received their medication and that they received it within the PBM return to stock timeframe. PAAS Audit Assistance members can refer to the PBM Return to Stock Chart on the PAAS National® Member Portal for a list of the major PBMs and their return to stock time frame allowances.

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PAAS often sees delivery/signature logs flagged for having a pre-printed delivery date. Several PBMs do not accept these logs because they may not represent the actual delivery date. Here is an example:

Recent Elixir results state, per the Elixir pharmacy manual, “Receipt submitted states “Delivery.” Unless the prescription delivery is through a common courier, an electronic or manual signature should be recorded at time of delivery by the member or designated member representative. For deliveries, the date delivered cannot be pre-printed by the pharmacy.”

Some software systems allow a pharmacy to “scan out” a prescription and flag it for delivery. The driver can take this date/time stamped point of sale receipt (that notates delivery) to the patient’s address and have them sign. PAAS also sees many LTC facility delivery manifests containing a pre-printed date on the document. An auditor is not going to accept/assume the delivery took place the same day as the pre-printed date and will likely flag these logs as invalid. The pharmacy needs to provide documentation of when the delivery took place by having the patient, or representative, date their signature upon delivery. Consider adding a blank line for a handwritten date next to the signature line that can be completed upon delivery.

PAAS Tips:

  • PBM Return to Stock requirements apply to retail and LTC pharmacies
  • A complete delivery/signature log 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 patient, or the signature of representative who accepted the delivery, or indication of COVID-19 if appropriate
  • If Mailing:
    • The COVID-19 pandemic had many PBMs make concessions to allow mailing during the Public Health Emergency (PHE). Keep up to date on concession expirations by downloading our COVID-19 PBM/Payers Concessions Chart 
    • The current COVID-19 PHE will expire 5/11/2023. See our article in next month’s Newsline for further considerations/implications.
    • If you are mailing out of state, be sure to check that state’s Board of Pharmacy to see if there are licensing requirements
    • PBMs that allow mailing will require proof that the patient received the medication and what was in the package
      • A tracking number linked to the prescription record along with tracking detail from the carrier showing the medication was delivered is traditionally sufficient
    • Be familiar with automatic mailing requirements for Part D patients, review the September 2022 Newsline article,  Automatic Mailing for Part D Patients
    • Read the November 2022 Newsline article, Yes, LTC Delivery Manifests ARE Needed!
    • The PAAS Trifold Signature Log Mailer is available for use on the PAAS Member Portal
  • If Medicare B DMEPOS Proof of delivery:
    • For in store pick-ups, the delivery date (date received) must match the date of service
    • For items delivered via a shipping service or mail, the date of service can be either the shipping date or delivery date
    • Read the June 2021 Newsline article, DMEPOS Proof of Delivery and Refill Request Requirements
  • Pharmacies using manual signature logs may want to consider ordering the PAAS National® Signature Logbook
  • Consult with your software vendor on updating your delivery/signature logs to include a signature date

Express Scripts Validating 340B Claim Eligibility

PAAS continues to see members receiving emails from Express Scripts (ESI) requesting pharmacies to “Please Review Your 340B Eligible Claims”.  ESI’s goal is to verify manufacturer rebate eligibility and states “your claims reimbursement, network participation, and network status are not affected by a claim’s status as 340B-eligible or whether you respond”.

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While seemingly haphazard in claim selection and frequency, Express Scripts is attempting to identify a subset of claim(s) that were initially processed as not 340B-eligible, but in actuality may have been dispensed/reimbursed as 340B. From communication with members, PAAS can see the algorithm ESI is using is far from perfect. Conjecture leads us to believe they are using the HRSA OPAIS website to look at providers and pharmacies, then targeting high dollar brand medications.

If the pharmacy agrees that the claims were 340B claims, no action is required and Express Scripts will reprocess the claim(s). If the pharmacy believes the claims were correctly adjudicated as non-340B eligible, the pharmacy should respond within 10 business days by emailing 340bclaims@express-scripts.com to refute Express Script’s conclusion.

PAAS Tips:

  • View PAAS’ webinar 340B Contract Pharmacy Considerations for 2021, which was based on ESI’s 340B Provider Manual changes
  • If your pharmacy is a 340B contracted pharmacy, follow up with your 340B administrator to ensure you have access to claims level detail
  • If the claim did not meet 340B criteria (e.g., ineligible provider, patient, or Medicaid eligibility) be sure to refute ESI’s findings with documentation

Update to PAAS’ Onsite Credentialing Guidelines

PAAS National® has created an Onsite Credentialing Guidelines, an extensive checklist to assist PAAS members with scheduled and/or unexpected visits from PBM auditors. Unannounced visits can catch pharmacy staff off guard when the Pharmacist-in-Charge (PIC) is not present. Be sure you are reviewing and advising your staff on the information included on this checklist so they are prepared.

There was an 11% increase in reported onsite audits over the past two years. PAAS takes pride in staying up to date on ever changing trends in pharmacy. Keeping our members informed on PBM inquiries during the credentialing process, or an onsite visit, is one of our priorities. We recently added the following updates to our Onsite Credentialing Guidelines:

  • Emergency Supply – Federal law requires Medicaid to provide at least a 72-hour supply of a covered drug to Medicaid patients in an emergency situation when prior authorization is pending as per 42 US Code 1396r-8(d)(5)(B). Pharmacists should use their professional judgement regarding whether there is an immediate need. See your state Medicaid agency for details on billing “emergency supply”.
  • Out of Stock Medication – Pharmacies must develop and follow procedures to ensure patients have timely access to prescribed medications. This may include ordering medication for next business day, transferring prescription to another pharmacy or contacting prescriber to obtain a prescription for an alternative therapy.
  • CMS 10147 – As of January 1, 2023, pharmacies must also include a Multi-Language Insert pursuant to CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F) published May 9, 2022. There is no requirement for pharmacies to document the distribution of the notice. Auditors may confirm that pharmacies are distributing the current version of the CMS 10147 and multi-language insert to beneficiaries. PAAS Audit Assistance members can see this month’s Newsline article, Multi-Language Insert Must Be Provided to Medicare Beneficiaries as of January 1, 2023.

Interested in having a customized FWA/HIPAA Compliance program? Contact PAAS to get started today! info@paasnational.com or 608-873-1342.

Audit Risk: Pre-Printed Prescription Forms

At a time when the workday seems to be growing ever more hectic, prescribers and pharmacies may find pre-printed prescription forms convenient; especially for medications which are frequently utilized by a prescriber for treatment. Many PBMs prohibit pre-printed prescription form use for various reasons. Forms created by the pharmacy for the prescriber are concerning because it could appear the pharmacy is soliciting prescriptions or attempting to steer the patient to their pharmacy, particularly if the pharmacy’s name and branding (logo) are pre-printed on the form. Concerns that the forms are not specific enough for each individual patient need with the same quantity, refill number, and directions can also come up.

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PAAS National® has seen pre-printed prescription forms considered invalid when they have cascading or overly broad substitutions. For example, if a topical medication is not covered, the form states the prescriber allows the pharmacy to substitute the next topical medication on the form and so on until one is covered. These medications tend to be more expensive than an alternative the plan may prefer and are a red flag for audit when the pharmacy is seen transmitting claims, reversing them, and billing a different product in rapid succession. Many PBM provider manuals have now added language requiring pharmacies to have a verbal conversation with the prescriber before making any substitutions, which would need to be proven with a clinical note documented on the prescription.

PAAS Tips:

  • Check the provider manual of the PBMs that you are billing to see if they prohibit the use of pre-printed forms. Currently, Elixir, Prime Therapeutics, CVS/Caremark, and Express Scripts all contain language about pre-printed forms and/or inappropriate therapeutic substitutions.
  • Clinical notes should contain the date, name and title of who you spoke with, summary of what was discussed, and pharmacy employee initials.
  • Pre-printed prescription forms with high-cost medications and/or cascading substitution could be a red flag and require further scrutiny.
  • Prescriptions should be specific to an individual patient’s needs and not generalized.
  • Eliminate the use of pre-printed prescription forms
    • Placeholder prescriptions for pharmacy-initiated dispensings (e.g., vaccines, OTC COVID-19 tests) has not been a concern

Why Does Billing the Correct Origin Code Matter?

Pharmacies are required to enter an origin code on claims to indicate where the prescription came from or “originated.” By definition, an origin code cannot change and should remain billed as how the pharmacy originally received the prescription from the prescriber, even when clarifications of that prescription are done by telephone.

Why does billing the correct origin code matter?

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In general, origin code errors are educational with a few exceptions. Humana will charge a $5 penalty fee for an incorrect origin code being billed when discovered on audit. This will be for the original claim and each refill also billed incorrectly (e.g., original fill plus 11 refills = $60 recoupment). If a telephone order is sent in for audit when billed with a different origin code, some auditors will assume the pharmacy could not find the “original” prescription and simply wrote one up. Auditors will mark the claim discrepant until the pharmacy can produce the prescription with the correct origin code or obtain a prescriber statement. Additionally, with Medicare Part D now requiring electronic prescribing of controlled substances (EPCS), CMS will rely on the origin code (initiated by the pharmacy) in the Prescription Drug Event (PDE) data to determine if physicians are adhering to the requirements.

NCPDP defines origin code values as follows:

CODE DESCRIPTION
0 Not Known
1 Written – Prescription obtained via paper.
2 Telephone – Prescription obtained via oral instructions or interactive voice response using a phone.
3 Electronic – Prescription obtained via SCRIPT or HL7 Standard transactions, or electronically within closed systems.
4 Facsimile – Prescription obtained via transmission using a fax machine.
5 Pharmacy – This value is used to cover any situation where a new Rx number needs to be created from an existing valid prescription such as traditional transfers, intrachain transfers, file buys, software upgrades/migrations, and any reason necessary to “give it a new number.” This value is also the appropriate value for “Pharmacy dispensing” when applicable such as BTC (behind the counter), Plan B, established protocols, pharmacists authority to prescribe etc.

Here are questions PAAS National® has frequently answered:

Question 1: If a pharmacy calls a prescriber to clarify a written prescription, or a change is needed, does the origin code become a “2” for Telephone?

Answer: No, the NCPDP Telecommunication FAQ section 3.1.5.3 states, “Because the prescription was received via written form the Prescription Origin Code is 1 and will remain a 1 throughout the life of the prescription number.” The same would be true if received by any other origin.

Question 2: If a prescriber sends a prescription electronically, but the pharmacy is not electronically-prescribing enabled or if there is a transmission error, and the intermediary drops the prescription to a fax, what origin code is used?

Answer: Per NCPDP, “Because the prescription was received at the pharmacy via fax the Prescription Origin Code is 4 and will remain a 4 throughout the life of the prescription number.”

Question 3: What origin code is used for a standard written authorization or protocol for services and products like, vaccines or Narcan®?

Answer: The NCPDP definition for protocols is Prescription Origin Code of “5” since the prescription is created by the pharmacy in these cases.

PAAS Tips:

  • Always bill the correct origin code to avoid potential recoupment.
  • The origin code remains the same through the life of the prescription.
  • Too many incorrect origin code discrepancies can lead to more frequent audits.
  • See the NCPCP Telecommunication Version D and Above Questions, Answers and Editorial Updates document for more information and scenarios.

Medicare Caps Copay for Insulin at $35 per Month

As most of you (and your Medicare patients) have undoubtedly noticed, Medicare has applied a $35 per month cap on copays for insulin prescriptions ($105 for a 3-month supply) for years 2023-2025. For 2026 and beyond, copays will be capped at the lesser of $35 or 25% of the negotiated price.

Section 11406 of the Inflation Reduction Act of 2022 implemented this cap for Medicare Part D and Medicare Advantage patients effective January 1, 2023, while Section 11407 requires implementation for Medicare B covered insulin as of July 1, 2023.

Plan Sponsors have a 90-day grace period to implement these copay caps and any excess copays calculated at adjudication must be refunded by the plan.

PAAS Tips:

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  • The definition of “one month” varies by plans
  • Pharmacies should collect the full copay amount as per online adjudication and advise patients that the plan will refund patients for any amounts in excess of $35 per month
  • Pharmacies should be extra diligent when calculating days’ supply and make sure you have mathematical instructions that support the days’ supply adjudicated
  • See the Insulin Medication chart and Can You Bill It As 30 Days? tool on the PAAS Member Portal for additional guidance
  • The CMS has created the following resources for Medicare patients
    • 7 Things to Know about Medicare Insulin Costs
    • Frequently Asked Questions About Medicare Insulin Cost-Sharing Changes in the Prescription Drug Law