USP 800 Compliance Program Updates: NIOSH 2024 List

USP 800 outlines the standards for healthcare providers that handle hazardous drugs, as defined by the National Institute for Occupational Safety and Health (NIOSH). Pharmacies that handle hazardous drugs (including carbamazepine, clonazepam, colchicine, and cyclosporine – these are just a few of the “C” drugs – there are over 400 unique drug/dosage forms in all that must be considered) should have a list of all hazardous drugs in their pharmacy, specific policies and procedures on how they will receive, store, and dispense these drugs, and provide staff training on specific policies and procedures. Pharmacies are also required to label the hazardous drugs to ensure staff are aware of occupational risks. Additionally, an “assessment of risk” must be performed and documented for each unique hazardous drug and dosage form to determine appropriate safety measures and minimize exposure.

NIOSH recently released the updated 2024 List of Hazardous Drugs in Healthcare Settings in December 2024. This list replaces the previously official 2016 list and must be incorporated into the USP 800 compliance programs for all healthcare entities as soon as possible.

The “2024 list” has various changes including:

  • Adding 25 drugs
  • Removing 7 drugs
  • Reducing the number of tables (from 3 to 2)
  • Reorganizing which drugs fall into the 2 tables

PAAS National®’s USP 800 Compliance Program has been updated to incorporate these changes and pharmacies utilizing the PAAS program will need to login to the Member Portal and perform the following steps to maintain compliance:

  1. Review your drug inventory for currently defined hazardous drugs using the PAAS’ Master Hazardous Drug formulary
  2. Review and finalize your Assessments of Risk and ensure staff are using these updated versions
  3. Review the updated Program Guide and print an updated Policy and Procedure Manual
  4. Educate staff about the NIOSH 2024 List changes. PAAS’ USP 800 Training module has been updated to reflect these changes, and quiz competency can be reset, if desired.

PAAS Tips:

  • Numerous entities can have oversight/enforcement of USP 800 including: state boards of pharmacy and OSHA
  • Pharmacies may be prompted to provide USP 800 policies and procedures to NCPDP during annual re-credentialing
  • USP 800 Compliance Program members should refer to the separate email communication for additional details.
  • Pharmacies interested in a turnkey USP 800 Compliance Program should review program details on the PAAS National® website or call (608) 873-1342 for additional information. Please note, the PAAS program is not intended for pharmacies that are compounding with hazardous drugs.

Keeping Your Suboxone Claims Safe from Recoupment 

As of December 29, 2022, the DEA no longer requires prescribers to include a DATA 2000 Waiver ID (commonly called an “XDEA number”) on buprenorphine prescriptions used to treat patients with opioid use disorder via the Consolidated Appropriations Act of 2023. With additional prescribers now able to issue prescriptions, and opioid dependence still plaguing America, oral buprenorphine products remain commonly used and filled by local pharmacies. 

A frequent problem that PAAS National® analysts see on audits is …

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the splitting of buprenorphine/naloxone tablets and films. The package insert explicitly states that the tablets and films should be taken whole and not to cut, chew, or swallow. Films have been approved to be administered sublingually or buccally, where tablets are only approved to be taken sublingually.

The question remains of how to handle a prescription where the prescriber writes for Suboxone® splitting films or tablets. The best practice would be to contact the prescriber and ask for a second prescription for the lower strength instead of splitting, where possible. Suboxone® films are available in 4 different strengths: 2-0.5 mg, 4-1 mg, 8-2 mg, and 12-3 mg.  Suboxone® sublingual tablets are available in 2 strengths: 2-0.5 mg and 8-2 mg. Interchanging between the Suboxone® products should only be done under prescriber supervision as the products are not bioequivalent.

PAAS Tips:

  • Prescriptions should have the patient’s address, prescriber’s address and prescriber DEA number on the hard copy
  • Verify all controlled substance state required elements are present, including but not limited to alphanumeric quantity and marked quantity checkboxes (where required)
  • Dosage form should be specified as tablets or films
  • Directions should be in full dose units
    • If smaller or larger doses are needed, a separate prescription should be issued instead of splitting/cutting tablets or films
  • Route of administration should be “buccal” (films only), “sublingual” or “under the tongue” (films and tablets)
    • Claims can be recouped for directions of “by mouth”

Medicare Billing for Insulin Pump Therapy

Pharmacies billing insulin vials for eligible Medicare patients must pay extra attention to ensure proper coverage. Since the frequency of dispensing insulin vials has greatly decreased due to the introduction of insulin pens, it is very important pharmacies take a pause and investigate how the patient is utilizing the insulin vials.

Medicare covers insulin vials both for self-administration via injections and when used in an insulin pump. When used in a pump, pharmacies must determine if Medicare Part D or Part B is appropriate. Confirming the correct billing falls on the shoulders of the pharmacy as the Medicare D plans will not reject claims at the point of sale. Incorrect billing is often not identified until months or even years down the road with limited ability for pharmacies to rebill.

PAAS National® has created a tool for pharmacies to help determine which Part of Medicare to bill. Considerations for Billing Insulin Vials: Medicare Part B vs Part D can be found on our website under Proactive Tips. Sharing this guidance with your pharmacy staff can help avoid costly recoupments.

PAAS Tips:

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  • When receiving a prescription for insulin vials, PAAS recommend verifying the following:
    • Is the patient Medicare eligible?Is the prescription for rapid-acting insulin?Is the patient receiving insulin syringes?
    • Is the patient using insulin in a pump?
  • Insulin used in a disposable (tubeless) pump does not meet Medicare Part B coverage criteria, therefore can be billed to Medicare Part D
    • Omnipod®, V-Go®, and CeQur Simplicity™ are examples of disposable insulin pumps
  • Insulin used in a durable (tubed) pump, for a patient that meets Medicare Part B coverage criteria, would be billed to Medicare Part B
  • Pharmacies that are not Medicare Part B suppliers are still required to follow these guidelines
  • Medicare Advantage Plans can be billed for insulin vials regardless of method of administration
  • Long-acting, pre-mixed or concentrated insulins are not approved to be used in insulin pumps
  • See the following Newsline articles:

Oral Inhalers – What You Need to Know About Institutional Pack Sizes

Oral inhaler prescriptions are frequently targeted for audit by PBMs because of their cost, frequent billing errors (e.g., incorrect days’ supply), or prescribing errors (e.g., non-mathematically calculable directions or incorrect written quantity). Vague written quantities can cause recoupments when multiple package sizes exist, including institutional package sizes.

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Institutional size packages primarily exist to allow pharmacies to dispense a smaller package for acute care and institutional settings. The existence of these products can cause audit discrepancies when a prescription is written for a quantity of “1 inhaler” or “1 unspecified.” Many retail pharmacies have expressed to PAAS National® that they cannot order the institutional size packages, so they assume billing one inhaler at the retail quantity is sufficient – auditors disagree. If multiple package sizes exist (including institutional size packages), an auditor will insist that they do not know what quantity the prescriber intended and require you to obtain a prescriber statement clarifying the quantity on appeal.

How can you preemptively avoid this situation? PAAS has updated our Oral Inhalers Chart to include a column for institutional size packages and their billing units. Train your technicians to look closely at the written quantity on the prescription. Does it make sense for the package size being dispensed? If the quantity is written for “1 inhaler,” is there an institutional size package or an additional package size to be considered? Clarify any incorrect, unspecified or ambiguous quantities with the prescriber and document a clinical note on the prescription prior to dispensing.

PAAS Tips:

  • Written quantities on a prescription should contain the proper billing unit of measure (UOM) per NCPDP guidelines, especially if multiple package sizes exist
  • Pay close attention to electronic prescription quantities which have the biggest potential for incorrect or “unspecified” UOM
  • Other prescription origins (written, fax, and transfer) may need clarification for missing UOM
  • Notating UOM on all telephone orders would be considered the best practice
  • Clinical notes should contain the date, the name and title of who you spoke with, a summary of your discussion, and your initials
  • Download the Oral Inhalers chart for the information on package sizes and other useful information like number of puffs per package, beyond use dates, and days’ supply calculations
  • Review our December 2024 Newsline article, 2024 Self-Audit Series #10: Nasal and Oral Inhaler Prescriptions, for more tips on audit-proofing your oral inhalers

Is Your Pharmacy Prepared for a Cyberattack?

In this episode of The Bottom Line Pharmacy Podcast, Scotty Sykes, CPA, CFP and Austin Murray sit down with Trenton Thiede, President of PAAS National®, to unpack the rising cybersecurity threats facing independent pharmacies and what owners must do to stay compliant and protected.

We dive into:

  • HIPAA compliance updates
  • AI risks, multi-factor authentication, and risk assessments
  • The growing pressure of PBM audits and the need for strong advocacy

Tune in by clicking on one of the links below:

FDA Approves First Rapid-Acting Insulin Biosimilar: MerilogTM (insulin aspart-szjj)

On February 14, 2025, the FDA approved the first rapid-acting insulin biosimilar, MerilogTM (insulin aspart-szjj) manufactured by Sanofi Aventis. MerilogTM is expected to reach the U.S. market in July 2025 and will require prescriber approval before pharmacies can substitute for other insulin aspart products such as Fiasp® or NovoLog®.

MerilogTM is the third insulin biosimilar approved by FDA (along with RezvoglarTM and Semglee®).

PAAS Tips:

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  • Review the November 2024 article, Understanding Biologic Substitutions – New Tool Available! for a refresher on terms used to describe biologic products such as reference product, biosimilar, and interchangeable
  • Remember to document prescriber approvals for substitution with a clinical note on the prescription or in your pharmacy software

Audit and Appeal Due Dates: Stay Ahead of the Clock with These Essential Tips

Pharmacy practice often revolves around meeting tight deadlines. Prioritizing can become challenging when you’re focused on providing prompt service to waiting patients or rushing to meet inventory ordering deadlines, all while managing your daily tasks. It’s tempting to push aside a PBM audit request, or its results, to tackle more immediate responsibilities. Unfortunately, neglecting audit or appeal due dates can lead to significant, and unnecessary, financial losses to the PBMs.

One of PAAS National®’s top priorities is helping pharmacies navigate the audit process successfully from start to finish. Remember to engage PAAS early by submitting your audit notice or audit results as soon as you receive them. Discussing your audit notice or results with your assigned analyst early can help you avoid unnecessary work when putting documentation together. This can also eliminate providing unnecessary information to auditors.

A great way to begin is by establishing a workflow process when audits are received. The following tips can assist you with a more efficient and effective audit outcome.

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Step 1: Audit Notice or Audit Results Received

  • Dedicate a specific area for audit documents and inform pharmacy staff of what to do when audit notices are received
  • Send your audit notice or audit results to PAAS as soon as you receive them
  • Discuss with your PAAS analyst the appropriate documents needed for response
  • Contact an auditor/PBM as soon as possible if you feel an extension may be needed
  • Set calendar reminders for audit and appeal due dates

Step 2: Prepare your Documents

  • Gather documents and organize in order of audit request
  • Always number your pages for easier reference for you, your PAAS analyst, and the auditor
  • When signature logs are requested on a separate list, keep those separate in your documents

Prescription Documents

  • While many audits request multiple dates of fill, only one prescription hardcopy is necessary for each Rx#
  • When printing electronic images of prescriptions, be sure to include any electronic clinical notations in your system for auditor to view
  • Reminder all clinical notes should include:
    • Date
    • Name and title of agent you spoke with
    • Specific information that was provided
    • Initials of pharmacy employee that made the call
  • Include any supporting documentation for DUR or SCC overrides
  • When backtags or labels are requested, these can be added to the same page as the prescription
  • Be sure backtags or labels do not cover any prescription elements
  • Keep backtags or labels in same orientation as prescription
  • Unless otherwise indicated, redact any pricing information

Signature/Delivery Requests

  • Always confirm if audit is requesting signature/delivery logs
  • Signature/delivery logs must include:
    • Rx number
    • Date of fill (or fill number)
    • Date dispensed
    • Patient/patient representative signature
  • Redact any PHI not on audit request

Proof of Copay Collection

  • Proof of copay collection is only needed when an audit specifically requests
  • Point-of-Sale transactions, register receipts, or A/R account invoices showing how payment was made may be necessary for responses
  • When secondary payors are involved, be sure to include claims data

Step 3: Submitting your Audit

  • Audit requests provide specific instructions on how to submit your documents
  • While faxing is typically an option, sending large audits this route is generally not advisable
  • Sending via secure email or uploading to a portal are the best recommendations

Step 4: Audit Outcome

  • Keep eyes open for audit results and inform staff of what to do when results are received
  • Set calendar reminder to follow up on audit status when results are not received on a timely basis
  • Remember, checking on your audit results will not change their outcome and may prevent you from missing an appeal deadline

Audit Results and Appeal

  • Audit appeals are individualized for each PBM and discrepancy
  • Review results closely for appeal deadlines as these vary per PBM
  • Involve your PAAS analyst right away as appeal documentation may take additional time and effort to obtain
  • Sending in your appeal documentation for your analyst review can be very helpful to identify any missing or incorrect information

PAAS Tips:

  • Send your audit notice or audit results to PAAS right away
  • Follow the PAAS National® guidance for Getting Help with an Audit
  • Submit audit notice, results or documents for review by uploading to our portal, faxing or emailing
  • When sending electronically, be sure to send as one aggregated file with numbered pages
  • If you send multiple attachments via fax or email, be sure each attachment is clearly labeled
  • Consult our Call Center if you need assistance with submitting your documents
  • Keep your PAAS analyst engaged on any updates or additional requests for your audit
  • Consider training additional staff to assist with your audits as a back up

Mailing Prescriptions? How to Ensure Audit Success

While some pharmacies make mailing prescriptions a regular practice, others may only do so on a case-by-case basis. PBMs require signature logs to prove that a patient received their medication in a timely manner, but how is proof obtained when the patient is not standing in front of you at the pharmacy counter?

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PBMs will require proof of delivery that contains information clearly showing what was in the package delivered. Most PBMs require a link between the delivery confirmation (via a tracking number) and the prescription record to show which prescription was being delivered. There should also be a patient signature or tracking detail from the carrier showing the date and location where the medication was ultimately received.

Notably, not all PBM agreements allow the mailing of prescriptions, while others may restrict mailing to a percentage. Humana and OptumRx typically prohibit mailing under retail agreements, and OptumRx further restricts delivery to within 100 miles by W-2 pharmacy employees. Caremark only allows up to 20% of their claims to be mailed.

Another consideration for pharmacies is ensuring you are licensed in any state you are mailing to. Many states have laws that require pharmacies to obtain a non-resident license to ship, mail, deliver, or dispense prescription medications into their states. Auditors look for these [expensive] claims to take advantage of well-meaning pharmacies who may not know of these requirements. Pharmacies located on state borders making deliveries into another state may also run into this problem as well.

PAAS Tips:

  • Have a system that links the tracking number to the prescription record to indicate the contents being shipped.
  • Print confirmation of delivery and keep it in a readily retrievable manner for audit – some carriers only keep tracking information for as little as 120 days, depending on the service used.
  • Before mailing/delivering prescriptions out of state, it is a good idea to check with that state’s Board of Pharmacy to see if there are any licensure requirements for doing so.
  • Be aware of your contract obligations and which PBMs do not allow mailing prescriptions to patients.
  • For all DMEPOS items and supplies billed to Medicare Part B, proof of refill request and an affirmative response is required to occur and be documented prior to shipment.
  • PAAS’ Proof of Refill Request and Affirmative Response for DMEPOS Items can be downloaded from our portal.
  • If you do not require signatures upon delivery, consider providing the patient with a copy of our Signature Log Trifold Mailer to sign, fold up, and mail back to the pharmacy.
  • Some PBMs, like Navitus Health Solutions, require a signature regardless of tracking information.
  • See the March 2025 Newsline article, Will Your Signature Logs Pass an Audit? for information on what auditors look for when patients pick up their medications or have them delivered.

Audit Considerations for Med Sync Programs

Medication synchronization (med sync) programs are common across pharmacies and yield many benefits. Patients can request it to manage medication better and reduce the number of trips needed to the pharmacy. Patient adherence increases and pharmacies can keep tighter control over inventory while having more efficient workflow.

NCPA promotes the improved adherence and quality of care through med sync programs. They call it a “once a month appointment day” for patients enrolled, saying pharmacist-patient dialogue increases with more time to focus on additional patient care services.

NCPA collaborated with the Arkansas Pharmacists Association to conduct a study measuring the impact of med sync programs on medication adherence and persistence across 82 independently owned pharmacies. The workflow tool was provided to the pharmacies by PrescribeWellness operating on 13 pharmacy management systems. Over 8,000 patients enrolled for this year-long retrospective cohort study. The key findings state that med sync patients are over 2.5 times more likely to be adherent to medications and 21% less likely to discontinue drug therapy. For more details, see the Study Overview and Full Report.

It’s a win all around – until it poses a waste or abuse issue. PBM audit algorithms are made to seek out fraud, waste, and abuse. PBMs will flag pharmacies for audit if claims are billed particularly early every month; for example, every 23 days on a 30 day’s supply.

PAAS National® recommends …

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having patients opt in for med sync with a signature that can be produced under audit, ideally with annual reverification. This way the pharmacy has evidence to support the patient requested enrollment. This enrollment should also include guidance on how a patient may ‘opt-out’. Med sync best practices also include a phone call [preferably documented] every month to affirm the refills needed prior to dispensing. Cycling the refills at ≥ 90% utilization can also help lower your risk of audit triggers from PBM algorithms that look closer at 75% utilization. Avoid putting bulk items on med sync, such as inhalers, insulin, eye drops or topicals. Med sync also shouldn’t apply to prescriptions written for as needed purposes or controlled substances.

PAAS Tips:

  • State pharmacy regulations may prohibit automatic refill programs or require additional documentation
  • Payer restrictions may apply for programs such as Medicare Part B/D and Medicaid
  • Automatic mailing and delivery of prescriptions often have additional requirements
  • Read Getting in Sync from NCPA’s America’s Pharmacist February 2024
    • See also the Pharmacy Operations Manual for SimplifyMyMeds® from NCPA February 2018

Respiratory Syncytial Virus (RSV) – What You Need to Know

There are currently three FDA-approved Respiratory Syncytial Virus (RSV) vaccines available for individuals at risk of severe illness from a respiratory virus. Please review the chart for helpful billing tips and the additional information below as to which RSV vaccine is appropriate to give to an eligible individual.

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Trade nameManufacturerNDCNCPDP Billing UnitSuggested Days’ SupplyTime to administer
 Abrysvo®*Pfizer00069-0344-011 EACH1 day supplyUse within 4 hours after reconstitution
   Arexvy®GSK58160-0848-11
mRESVIA®**Moderna80777-0345-900.5 MLUse within 24 hours after thawed at room temperature

*Also available in 5 and 10 kit packages       **Also available in a pack of 10 pre-filled syringes

  1. Abrysvo®
    1. 60 years of age and older
    1. Pregnant women at 32 to 36 weeks gestational age
    1. 18 – 59 years of age who are at an increased risk
  2. Arexvy®
    1. 60 years of age and older
    1. 50 through 59 years of age who are at an increased risk
  3. mResvia®
    1. 60 years of age and older

The CDC recommends a single dose of any FDA licensed RSV vaccine be given to all adults ages 75 and older and adults who are between the ages of 60 and 74 who have an increased risk of severe RSV. The conditions that increase the risk of severe RSV can be found on the CDC website. The CDC also recommends pregnant women receive a dose of the maternal RSV vaccine (Abrysvo®) during weeks 32 through 36 of their pregnancy sometime between September through January.  To prevent severe RSV in infants, it is recommended that the mother receive the maternal RSV vaccination or the infant receive the vaccination with RSV monoclonal antibody.

PAAS Tips:

  • Be cautious when billing mRESVIA® as each pre-filled syringe is billed as 0.5 mL versus the Abrysvo® and Arexvy® vials which are billed as 1 EACH
  • Medicare covers RSV vaccine under Part D
  • Pharmacists play a key role in educating high-risk patients on RSV prevention
  • Eligible patients can receive the RSV vaccine at any time, but the best time to vaccinate is late summer or early fall before RSV starts to spread
  • Like all vaccines, pharmacies should maintain documentation in case of an audit:
    • Authorization to administer, which may include a patient-specific prescription or a collaborative practice agreement (CPA)/protocol
    • Signed prescription or placeholder prescription (when using a protocol or CPA)
    • Vaccine Administration Record (VAR)
    • Screening checklist
    • Vaccine Information Statement (VIS)