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*

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

Are You Documenting DUR and Submission Clarification Codes?

PAAS National® is continuing to see Express Scripts (ESI) and Tricare flag claims for audit where clinical drug utilization review (DUR) or submission clarification codes (SCC), were submitted. Prime Therapeutics, now processed by ESI, has now joined in. Recoupments are happening due to “No DUR documentation” or “No SCC documentation.” Pharmacies that fail to show documentation of the support codes used on the prescription are facing recoupment.

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Dispensing pharmacists must use professional judgement when receiving a point-of-sale reject. If choosing to dispense a medication using an override code, it is imperative that supporting documentation be placed on the prescription to support its utilization. This documentation should contain detailed information with dates, names, titles, and discussions that took place if patients, or prescribers, were consulted. Lack of this documentation can lead to recoupment.

Most common SCCs subject to audit (as defined by NCPDP) are:

Please click here to view all 37 NCPDP Submission Clarification Codes and their corresponding definitions. There are additional codes found in the link that pertain to LTC billing, compounds and 340B. Drug utilization review codes can be found as follows: Reason for Service Code, Professional Service Code (NCPDP 440-E5) and Result of Service Code.

PAAS Tips:

  • Make sure all documentation is made on the original prescription or with an electronic note that can be retrieved upon audit request
  • Clinical notations should contain all four elements: date, name and title of person you spoke with, what was discussed and initials/name of pharmacy personnel that made the call
  • Be sure any notations made on previous prescriptions are carried forward to new prescriptions if you are using this as supporting information
  • Documentation should clearly support specific override code(s) submitted
  • Specific information to support vacation supplies and lost medication is recommended
    • For example: date of request, number of days patient will be gone, or amount of medication lost
  • Professional service code “M0” will require consultation with prescriber and appropriate documentation

Webinar: 340B Contract Pharmacy Considerations for 2021

PAAS National® is hosting a webinar on Wednesday, March 3 from 2:00-2:45 p.m. CST

We look forward to you joining us as President of PAAS National®, Trenton Thiede, PharmD, MBA:

  • Reviews 340B audit risk
  • Looks at Medicaid considerations with 340B
  • Reviews the 340B claim identification and submission requirements
  • Discusses the two-tier (aka discriminatory) pricing model
  • Explores a recent PBM communication released on February 24, 2021

Bring your questions, we will do our best to allow some time for Q&A at the end of the webinar.

PAAS Audit Assistance members will have access to a recording on the member portal if you are unable to attend the live event.

Reminder first step to using your audit assistance with PAAS National® is when you receive an audit notice call PAAS 608.873.1342 to get a case set-up then email info@paasnational.com or fax 608.873.4009 in your audit notice.

Our all-inclusive audit assistance membership means there are no hidden fees or limits to the audit assistance you can receive. We are here to help you!

Not a member? Join today!

FDA Requests Updated Product Labeling on Insulin Pens

Stop Breaking Insulin Pen Boxes

The pharmacy industry has long debated whether one box of insulin pens is considered “unbreakable”. The debate appeared to be settled January 22nd, 2019 when the U.S. Department of Justice issued a press release stating Walgreens agreed to a $209 million fraud settlement with the federal government regarding its billing and dispensing of insulin pens to Medicaid, Medicare Part D and TRICARE patients. Prior to the settlement, Walgreens’ policy was to not dispense any insulin pens in quantities less than one full box, forcing their staff to falsely understate the days’ supply on thousands of claims. They then enrolled many of these patients on its refill reminder program, causing patients to get early refills. The government labeled that billing activity as
widespread FRAUD and required Walgreens to enter into a Corporate Integrity Agreement with the Office of the Inspector General. Consequently, both Walgreens and CVS have been breaking insulin pen boxes when appropriate. Read the full urgent member alert here.

Caremark Manufacturer Coupon Policy

PAAS National® continues to see pharmacies suffer full recoupment on claims that are processed to coupons and copay cards in violation of Caremark’s policy found in section 3.03.03 of the 2020 Pharmacy Provider Manual. Violations are considered [by Caremark] to be an inappropriate waiver of patient pay amounts and could result in additional sanctions, including termination.

As defined in the current Provider Manual: “Pharmaceutical Manufacturer Coupon” means any item or mechanism, including but not limited to, paper coupons, copay cards, e-vouchers, mail-in rebates, and electronic coupon codes funded by a manufacturer, repackager, or supplier of pharmaceutical, chemical, or compounding products, that reduces the portion of the Patient Pay Amount that an Eligible Person is required to pay for a Covered Item.

Manufacturer coupons may be accepted if:

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  1. Pharmacy complies with all the terms and conditions specific to the coupon – including prohibitions on using for federally funded programs such as Medicare, Medicaid, and TRICARE
  2. The coupon is applied by your pharmacy location and not a hub
  3. The item is NOT a compound drug, 510(k) cleared medical device or Medical Food
  4. The item falls into one of the following categories:

a. Approved as a brand (NDA) or generic (ANDA) drug and published in the FDA Orange Book

b. Approved under a Biologics License Application (BLA) and published in the FDA Purple Book

c. Over-the-Counter (OTC) item marketed under an official final OTC monograph

d. Grandfathered drug marketed before 1938 or 1962, or is otherwise considered Generally Recognized as Safe and Effective (GRASE) by the FDA

PAAS Tips:

  • Pharmacies typically run afoul of Caremark with products sourced from secondary distributors identified as dietary supplements, medical foods or medical devices
    • These are typically products with large patient copays
  • Don’t assume that a product is “FDA approved” just because it has an NDC number
  • Use the following websites to determine FDA marketing status
    • FDA Orange Book
    • FDA Purple Book
    • DailyMed
  • If you are ever in doubt about a product, call PAAS at 608-873-1342 so that we can help you identify whether it will be a problem
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Mid-Level Practitioners and Their Supervising Physicians– Documentation Required?

PAAS National® has seen a recent uptick in the number of prescriptions being found discrepant for missing the supervising physician when written by a mid-level practitioner (e.g. physician assistant or nurse practitioner). Laws pertaining to mid-level practitioners are specific to each state and may differ between physician assistants and nurse practitioners. Because these regulations may be found through the Board of Medicine or Board of Nursing, pharmacies are not always aware of the requirements to make a valid prescription. In particular, many states require the name of the supervising physician be present on the prescription hard copy.

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PAAS Tips:

  • Check your state’s laws regarding what is required for a valid prescription, including those through the Board of Pharmacy, Board of Medicine and Board of Nursing
    • Physician assistants and nurse practitioners may have separate requirements under the Boards of Medicine and Nursing
  • Check with your software vendor to see if the supervising physician is being transmitted by the doctor’s office but not pulling forward on an electronic prescription
    • There may be a “short” and “long” version of the electronic prescription that can be printed
  • If a supervising doctor is required on a prescription but not present, call the prescriber’s office to find out who the supervisor is and note the name on the prescription

PAAS National® is committed to serving your needs and helping you reduce audit risk.

Upon receiving notification for an audit or results, contact us so we can assist you throughout the audit process

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PBM Enforcement of Return to Stock Policies

PAAS National® wrote an article in our April 2020 Newsline regarding PBMs Enforcing Return to Stock Policies. A PBM will recoup a claim in full if a medication is picked up after their required return to stock timeframes listed in the respective provider manuals. The provider manual may reference these as “unclaimed prescriptions.” Pharmacies should have a policy and procedure in place to only allow medications to remain in the will call bins for the shortest outlined time – 10 days. If your pharmacy has PAAS National®’s Fraud, Waste & Abuse and HIPAA Compliance (FWAC) program, a return to stock policy is available to you, including a log to help you document and complete this task (see section 4.1.1 Unclaimed Prescriptions and Appendix B – Unclaimed Prescription Reversal Log).

Major PBM Return to Stock Timeframes:

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Calendar Business
10 days 13 days 14 days 10 days 15 days
MeridianRx
Serve You Rx
TRICARE		 Express
Scripts		 Aetna
Caremark
Elixir
MagellanRx
MedImpact
Navitus
OptumRx
Prime Therapeutics		 Southern
Scripts		 Humana

PAAS Tips:

  • Pharmacies should not leave prescriptions in the will call bins for more than 10 days to comply with the shortest return to stock timeline of 10 days per MeridianRx, Serve You Rx and TRICARE.
  • These return to stock timelines also apply to completions (aka “partial fills”) left in the will call bins
  • PBM return to stock policies are still required to be met during the COVID-19 pandemic
  • LTC prescriptions are not exempt from these return to stock policies
  • If you are a FWAC member and change your procedure for returning medications to stock, be sure to have your admin or compliance officer update section 4.1.1 of your Policy and Procedure manual
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