Facing Potential Disciplinary Action? PBMs Require Notification!

It can be a very stressful time for a pharmacy when they, or an employee, are being investigated by a regulatory body (e.g., Board of Pharmacy, Office of Inspector General (OIG) or Drug Enforcement Agency). It will likely not be the first thing on your mind to notify contracted PBMs. Consider

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paraphrased language from the OptumRx Provider Manual:

  • OptumRx is partnered with NCPDP for credentialing—all pharmacies are required to maintain Part 1 and Part 2 of their profile with NCPDP
    • Credentialing documentation must be provided within 48 hours if requested
    • Re-credentialing occurs every 3 years
  • OptumRx must be notified within 7 days, in writing, and include information regarding the agency who is conducting the investigation, if:
    • The Pharmacy Providers license/permit is in jeopardy of being suspended or revoked
    • The Pharmacy Provider receives notice of any proceedings which may lead to disciplinary action
    • Any disciplinary action is taken against the Pharmacy Provider or employees, including but not limited action taken by a Board of Pharmacy, OIG, GSA, law enforcement or other regulatory body
    • There is a subpoena of records related to Covered Prescription Services or the Pharmacy Providers business conduct
    • Seizure by law enforcement of the Pharmacy Providers prescription records, computer systems, financial records, accounts, or real property
  • Failure to report to OptumRx can result in immediate termination or suspension from the network

It’s important to note that OptumRx is requiring notification even if no disciplinary action was taken against the pharmacy or the employee. Every PBM may have different requirements, but the major PBMs require some sort of notification. Be sure to review a copy of the Provider Manual if you are unaware of the regulations regarding this issue.

These situations often arise after re-credentialing as PBMs are reviewing the credentials of pharmacy employees. PAAS National® has successfully assisted pharmacies facing Network Termination due to a failure to notify. Notify PAAS right away if you’ve received a Letter of Warning (Contract Violation) leading to a breach of the Provider Agreement.

AmerisourceBergen ThoughtSpot 2021: Navigating Pharmacy Audits Amidst a Pandemic

Pharmacy audits continue to morph as Pharmacy Benefit Managers (PBMs) develop new methods to recoup prescription claims. Understanding the many facets of the audit process, including triggers, trends, and prevention strategies will enable your pharmacy to be more successful in an audit situation.

On Tuesday, August 3, 2021 from 2:00-3:30 p.m. EST, Trent Thiede, President at PAAS National® and Tracie Acosta, Manager of Provider Network Quality Compliance from Elevate Provider Network will be virtually presenting Navigating Pharmacy Audits Amidst a Pandemic in an online CE webinar at the AmerisourceBergen ThoughtSpot 2021.

Time will also be spent discussing the unique challenges immunizations, 340B claims, compounds, and LTC prescriptions present on audits. Takeaways from this session include:

For catching this webinar session and more, visit the ThoughtSpot 2021 website: https://www.wearegnp.com/thoughtspot2021

Announcing the new PAASNational.com

After many months of hard work and dedication from our team, we are pleased to announce that on June 22, 2021 we launched the new PAAS National® website paasnational.com.

The primary goal of the redesign was to create a valuable, mobile friendly resource for visitors to access information on PAAS Audit Assistance and Fraud, Waste & Abuse/HIPAA Compliance services and keep up-to-date on news and events. Visitors can also easily view the different membership offerings at https://paasnational.com/buy-now/.

PAAS members have access to the PAAS member portal by clicking the “Member Login” button in the upper right hand corner of the screen to unlock the resources available with their specific membership type, which may include: audit assistance, proactive tips, on-site credentialing tools, days’ supply charts, COVID-19 resources, recorded webinars, guidance on filling and billing prescriptions, policy and procedure manual, risk analysis, FWA/HIPAA training, OIG & GSA exclusion list checking and more.

The website also includes member testimonials and audit assistance results. We love hearing from our members at info@paasnational.com and we have made it easier to refer a friend: https://paasnational.com/refer-a-friend/

We hope you enjoy the new website! For any suggestions, questions or comments please contact us: https://paasnational.com/contact/

Celebrating 1 Year of License Tracking with the PAAS Vault

This month at PAAS National® we celebrate one year of the launch of the PAAS Vault. This product was developed to help pharmacies access their important documents easily, and safely store them securely in one central location. Available to you at your fingertips 24/7 to assist in reducing the stress of having to search for each document.

From our members:

“We are a small ma/pa shop. We renewed the PAAS Vault as we can see how easy it is for renewals during that time of the year.”

“Our pharmacy was previously in the need of a better way to track the expiration of our licenses, certificates, insurance, contracts, etc. The PAAS vault provided us the ability to have one web-based platform that was able to house the necessary documents needed to maintain compliance as well as track upcoming expiration dates. The trial has been very valuable. It has allowed me to play around with the features of this new service and see first-hand the benefit it provides to our compliance program. The part I like best is that I can attach physical documents as well as enter expiration dates where I can quickly see on the dashboard page upcoming expirations that need to be addressed. I would like to be able to use this service in an expanded way in the future. For example being able to store payer audit documents/findings, board of pharmacy inspection reports, and payer contracts for easy retrieval.”

“Going to be really useful. I forgot to renew one and that shouldn’t happen now with the [PAAS] Vault program. About 2/3 of the way done entering info. I really like the reminders, so nothing slips through the cracks. Great safety net.”

“We like the [PAAS] Vault and having everything at your finger tips and easily accessible. It is an easy application, easy to upload files, reminders auto send out and will save alot of last minute scrambling and headaches.”

“Keep track of licenses, as we currently just have reminders set-up on our calendar. The trial has been valuable to us, which is an add-on for FWAC members at $99/year after the trial period.”

PAAS National® FWA/HIPAA Compliance members that have added the PAAS Vault can upload, retrieve, and print their documents fast and easy with just a few clicks. With the custom alerts and reminders, the PAAS Vault makes it is easy to know when these documents need renewing as well.

Let us know if you have any questions or concerns on how to use the PAAS Vault. Compliance Officers and Administrators can also refer to the PAAS Vault User Guide found on the Help page of the PAAS Portal.

Not a PAAS FWA/HIPAA compliance member? Contact us today at (608) 873-1342 or info@paasnational.com and save $120 by combining services with PAAS Audit Assistance.

Webinar: Thriving Against PBM Audits – Audit Trends and PBM Tactics

On June 23, 2021 PAAS National® hosted Thriving Against PBM Audits – Audit Trends and PBM Tactics webinar. PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Member Portal.

This webinar reviews:

  • Audit trends across the United States
  • New and persistent ways PBMs are recouping money from community pharmacies, including:
    1. COVID Vaccine Audits
    2. Off-label COVID Treatments
    3. Prescription Requirements
    4. Diabetic Testing Supplies
    5. Insulin Pens

COVID-19 Vaccine Billing Guidance (April Update)

PAAS National® has seen a few COVID-19 vaccine audits since pharmacies began billing and administering within the last few months. This article contains some reminders and updates from our January 2021 Newsline COVID-19 Vaccine Billing Guidance. As a general rule, vaccine claims are lower risk for PBM audit; however, audits are always possible, and you should be prepared with good documentation. PAAS highly recommends creating a placeholder “prescription” with all required elements for your records – many pharmacies already do this when billing for other vaccines under protocol. Additionally, it will be necessary to document the administration through a vaccine administration record as well as provide the patient with an Emergency Use Authorization (EUA) fact sheet (in place of a vaccine information sheet). Be sure to submit the correct quantity, days’ supply, SCC code and CPT code depending on which vaccine you are administering. Please see the chart below for a reference.

The coverage for COVID-19 vaccine may be under the pharmacy benefit (via NCPDP standard) or the medical benefit (via CPT codes). Here is a summary of billing information known to PAAS:

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Pharmacy Benefit* Medical Benefit
Vaccine NDC-11 Billing Quantity & Units Days’
Supply
Dose 1 Dose 2 CPT Codes Dose 1 Dose 2
Pfizer-BioNTech1 59267-1000-01 0.3 mL 1 SCC-02 to indicate “first dose” SCC-06 to indicate “final dose” 91300 0001A 0002A
Moderna2 80777-0273-10 0.5 mL 1 91301 0011A 0012A
Janssen3 59676-0580-05 0.5 mL 1 N/A 91303 0031A single-dose N/A

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(1) Pfizer BioNTech vaccine has a package size of 1.8 mL and will deliver 6 doses of 0.3 mL

(2) Moderna vaccine has a package size of 5 mL and will deliver 10 doses of 0.5 mL

(3) Janssen vaccine has a package size of 2.5 mL and will deliver 5 doses of 0.5 mL

*NCPDP also recommends that pharmacy claims will need to submit the following for ZERO-COST vaccines:

  1. Professional Service Code (440-E5) of “MA” (Medication Administered)
  2. Ingredient Cost Submitted (409-D9) of $0.00 or $0.01
  3. Incentive Amount Submitted (438-E3) to request payment for administration
    • Effective on March 15, 2021, the Medicare Part B payment rate for immunizers will be $40 to administer each dose of a COVID-19 vaccine
    • The exact payment rate for administering a COVID-19 vaccine can depend on the type of entity that provides the service and will be geographically adjusted based on where the service is provided.
  4. Basis of Cost Determination (423-DN) of “15” (free product or no associated cost)

PAAS Tips:

COVID-19 Vaccine Billing Guidance

The light at the end of the tunnel is approaching as Operation Warp Speed delivered COVID-19 vaccines to healthcare workers and LTC residents in December 2020. There will certainly be bumps in the road, supply chain delays and allocations, which means that most patients will not be able to receive COVID-19 vaccines until mid- to late 2021.

The federal government has pre-paid for millions of vaccine doses and will be distributing them to health care providers at no cost, which means that when government-supplied vaccine becomes available at community pharmacies, you will not have to pay to acquire it. For vaccine doses supplied by the federal government, pharmacies may NOT charge patients for the vaccine itself, but may bill payers for the administration. The federal government has mandated coverage under Medicare Part B, Medicaid and Commercial insurance with no out-of-pocket costs to patients. The CARES Act also provides for reimbursement for uninsured patients through the Health Resources & Services Administration (HRSA).

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Payer Coverage and Billing Considerations
Medicare Part B
  • PHARMACY must enroll as Part B Provider (either as supplier type Pharmacy or Mass Immunizer)
  • Two-dose vaccine administration reimbursement = 1st dose $16.94, 2nd dose $28.39
  • Single-dose vaccine administration reimbursement = $28.39
Medicaid
  • May be covered under pharmacy or medical
  • All programs required to cover – FFS and Medicaid MCO
  • Reimbursement will vary
Commercial
  • May be covered under pharmacy or medical
  • Payers MUST cover it for both in-network AND out-of-network providers
  • Reimbursement will vary
Uninsured
  • Pharmacies may bill HRSA – managed by “OptumPay” (must be contracted) – not the same as OptumRx

The coverage for COVID-19 vaccine may be under the pharmacy benefit (via NCPDP standard) or the medical benefit (via CPT codes). Here is a summary of billing information known to PAAS National® as of December 23, 2020.

Vaccine NDC-11 Billing Quantity Days’ Supply Dose 1 Dose 2
Pfizer BioNTech 59267-1000-01 0.3 mL 1 SCC-02 to indicate “first dose” SCC-06 to indicate “final dose”
Moderna 80777-0273-10 0.5 mL 1

NCPDP also recommends that pharmacy claims will need to submit the following for ZERO-COST vaccines:

  1. Professional Service Code (440-E5) of “MA” (Medication Administered)
  2. Ingredient Cost Submitted (409-D9) of $0.00 or $0.01
  3. Incentive Amount Submitted (438-E3) to request payment for administration (e.g., $16.94 or $28.39)
  4. Basis of Cost Determination (423-DN) of “15” (free product or no associated cost)

*New guidance sent 3/15/2021 and updated article published 4/2/2021, available to members in the PAAS Portal*

FWA and HIPAA Compliance with Job Shadows and Interns

Students performing a job shadow or internship in the pharmacy need proper FWA/HIPAA training and preparation to be behind the pharmacy counter or you are inviting headaches into your operations (and potential legal complications).

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Ensure all students entering the professional area of the pharmacy have received proper HIPAA training. They will undoubtedly be exposed to Protected Health Information (PHI) and must know the proper policies and procedures to prevent a breach. Private information about friends, classmates, relatives, or other community members may be learned and this information could be tempting to share with others. By completing HIPAA training prior to exposure to PHI, the students will have a better understanding of the problem with disclosing PHI, including the civil monetary penalties and criminal consequences.

Pharmacy students completing their internship typically spend more time in the pharmacy than someone job shadowing. Interns assisting with daily operations such as billing, filling, counseling, and other professional services, must also complete FWA training. Though their time with your pharmacy may be temporary, these students have access to many of the same pharmacy operations as regular employees. The potential to oversee or partake in wasteful practices, diversion, or other fraudulent activities exists and FWA training must be completed. PAAS National® also recommends completing exclusion checks for interns against both the Office of Inspector General (OIG) and General Services Administration (GSA) lists.

PAAS FWA/HIPAA Compliance members can easily add students to your employee list in the PAAS Member Portal to give them access to the FWA/HIPAA online training modules and automatically receive daily OIG and GSA exclusion checks when the student’s profile is created.

PAAS Tips:

  • Before entering the professional service area of the pharmacy all students should complete HIPAA training
  • All interns should also receive FWA training
  • All interns should be checked against the OIG and GSA exclusion lists before entry into the pharmacy and at least monthly thereafter
  • Students performing a job shadow should have direct supervision
  • Check with your board of pharmacy for the required oversight of pharmacy student interns
  • PAAS FWA/HIPAA Compliance members should modify the student’s “termination date” when their rotation through your pharmacy ends to remove them from your list of active employees

Contact PAAS National® at (608) 873-1342 or info@paasnational.com for assistance regarding student access to the portal or to become an FWA/HIPAA Compliance member.

Pitfalls of Transferred Prescriptions

Transferred prescriptions are at high risk for audit recoupments. Every element required by state regulations is one additional pitfall that PBMs utilize to try and recoup on claims. These prescriptions are easily identified due to their origin code. The NCPDP Telecommunication Version D section 3.1.4 explains that an origin code of 5 is utilized for any pharmacy created prescription, which includes when pharmacists have authority to prescribe, when dispensing off a protocol and for prescriptions transferred in.

PAAS National® analysts frequently see audit results with recoupments for:

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  • Missing transfer elements – always double check your transferred prescriptions against your state’s transfer requirements to avoid these recoupments. Contact PAAS (608) 873-1342 or info@paasnational.com if you need assistance obtaining a copy.
  • Original written date – claims may be flagged as invalid when the written date is input incorrectly as the transfer date. Additionally, entering an incorrect written date could cause the pharmacy to accidently dispense the medication after the legal expiration date.
  • Central file – pharmacies that share a central file appear to be the newest pitfall with transferred scripts. Prescription data is maintained on one system for pharmacies under common ownership and the software allows for seamless sharing of information. This makes prescription transfers more efficient as the data is visible by all pharmacies on the shared system and a prescription can be pulled to a new location with a few keystrokes. Pharmacies have seen hefty recoupments during audits for missing transfer information by not providing sufficient data to show all transferred elements or common ownership and proof of a central file. PAAS has successfully assisted pharmacies facing recoupment for this issue and have already saved these members over $230,000.

PAAS Tips:

  • Review state transfer regulations
    • Ensure staff involved in taking, giving, and billing transferred prescriptions are familiar with the required elements of a valid transfer in your state
    • Create transfer Rx blanks with all required elements
  • Routinely perform a self-audit for prescriptions with an origin code of 5 and check hardcopies for accuracy

Updated Dispense in Original Container Chart

Medications that are required to be dispensed in their original container continue to appear in audits. Billing for a quantity that is not divisible by the full bottle size is a red flag to the PBM and, unfortunately, easily recoupable. Many of these products are sensitive to light/moisture or have only been studied under storage in their original container; thus, removing them from the original package may cause stability and potency issues. Product labeling can be obtained from the FDA’s DailyMed website, which was referenced by PAAS National® to update the Dispense in Original Container chart under the Tools & Aids section of the PAAS member portal.

For example, PAAS analysts have seen an increase in

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questions regarding Truvada® for HIV post-exposure prophylaxis (PEP). Prescribers are issuing scripts for 28 days to follow the PEP treatment guidelines by the CDC, but one of the drugs included in the CDC 28-day PEP treatment regimen is Truvada®, which comes in 30-count bottles with labeling to “dispense only in original container.” PAAS cannot recommend dispensing outside of FDA guidelines and advises the pharmacy to obtain authorization from the prescriber to dispense the full bottle.

Additionally, pharmacies dispensing to nursing homes or providing medication packaging to patients in the retail pharmacy setting must also follow the FDA guidelines to dispense in the original container.

PAAS Tips:

  • Print and display a copy of the PAAS National® Dispense in Original Container chart near the billing station
  • Place labels on the shelf by products required to be dispensed in their original container
  • Only bill these products for quantities divisible by the full bottle size to decrease audit risk
  • If necessary, contact the prescriber for authorization to change the prescribed quantity to facilitate dispensing in the original container and document the change with a clinical note
  • Contact PAAS with concerns or for further clarifications