Are You Prepared to Prove TIRF REMS Program Compliance?

The purpose of the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Program is “to mitigate the misuse, abuse, addiction, overdose, and serious complications due to medication errors with the use of TIRF medicines.” If your pharmacy dispenses Actiq®, Fentora®, Subsys®, or other medications which fall under the TIRF program, now is a good time to evaluate your compliance with all TIRF REMS requirements. The program has strict standards for all stakeholders involved with TIRF products including program administrators, wholesalers, prescribers, pharmacies and patients. Annually, the program administrators must audit all certified outpatient pharmacies who ordered at least one shipment of a TIRF medication in the preceding 12 months, up to 400 pharmacies.

PAAS National® analysts have seen audits recently conducted by Compliance Architects®, a company which offers many services including FDA risk management and compliance consulting. The audits have consisted of a short online survey followed by a self-scheduled virtual meeting. During the audit process, pharmacies are expected to share copies of various program-related documents such as:

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A key factor to successfully completing the audit is being able to provide robust policies and procedures which meet all program requirements. Whether you’re reviewing your current policies and procedures, or find yourself without this key compliance element, reviewing the Pharmacy Education document found online under the Pharmacy page of the TIRF REMS Access Program website is a good starting point. Mirroring each section from the Pharmacy Education document in your own policy and procedure can help ensure all compliance elements are captured.

If your pharmacy is found to be non-compliant, the type and severity of the offense determines the reprimand (which may consist of a corrective and preventative action plan, continued monitoring for compliance or potentially deactivation from the TIRF REMS program). A copy of the TIRF REMS Non-Compliance Protocol can be found on the Access Program website.

PAAS Tips:

  • All pharmacies dispensing TIRF REMS medication must have an Authorized Representative who successfully completed the TIRF REMS Pharmacy Knowledge Assessment, submitted the Pharmacy Enrollment Form and attested to following all program requirements.
  • Ensure all staff involved in the ordering, inventory management and dispensing of TIRF REMS medications have been trained by the pharmacy’s Authorized Representative.
  • The pharmacy must re-enroll and successfully complete the enrollment requirements every two years. The PAAS Vault can be utilized to store your enrollment forms and proof of training to ensure they are readily accessible for an audit. For more information on the PAAS Vault call 608-873-1342.
  • Have robust written policies and procedures which outline how your pharmacy will meet all program requirements including, but not limited to:
    • Checking for changes in a patient’s medication use and opioid tolerance
    • Documenting the patient’s around-the-clock opioid medication and RDA
    • Verifying the prescriber and the patient are enrolled in the TIRF REMS Program
    • Providing the patient with the product-specific Medication Guide and counseling
    • Reporting adverse events
    • Prohibiting the distribution, transfer, loaning or selling of TIRF medicines to other providers
  • For access to the full FDA TIRF REMS program information, access the FDA REMS online database

COVID-19 Oral Therapeutics Antiviral Billing Guidance

Two oral products have received Emergency Use Authorization for the treatment of COVID-19 infection – PaxlovidTM (Pfizer) and Molnupiravir (Merck). Both products are a 5-day course and are only authorized for dispensing pursuant to a patient-specific prescription or delegated collaborative practice agreement. Unfortunately, the FDA did not authorize independent prescribing by pharmacists.

Like the COVID-19 vaccines, oral therapeutics are purchased by the federal/state government and distributed to pharmacies at no cost. However, oral therapeutics are in very limited supply and only available to pharmacies that are part of the Federal Retail Pharmacy Program or directly from state health departments. Also, similar to the COVID-19 vaccine, oral therapeutics must be dispensed with no cost to the patient.

Billing

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Here are some excerpts from NCPDP Emergency Preparedness Guidance on billing for free product:

  • Ingredient Cost Submitted (NCPDP field 409-D9) of “$0.00” (you may need to use “$0.01”)
  • Basis of Cost Determination (423-DN) of “15”
  • Dispensing Fee Submitted (412-DC), submit your typical fee that you otherwise would for any other claim (e.g., $12.00)
  • Professional Service Code (440-E5) of “PE” due to extra consultation needed with these products
  • Incentive Amount Submitted (438-E3), submit additional fee associated with professional service code
Drug NDC Quantity Common Dosing Common Day Supply
PaxlovidTM 300 mg-100 mg tablet 00069-1085-30 30

20*

 3 tablets BID x 5 days

2 tablets BID x 5 days (renal)*

 5
Molnupiravir 200 mg capsule 00006-5055-06 40

*Renal dose adjustment for eGFR <60 but ≥ 30 mL/min

Reimbursement

While Medicare has covered COVID-19 vaccines under the Part B (medical) benefit, the oral therapeutics are a Part D (pharmacy) covered benefit. Medicare has not required plan sponsors to pay a dispensing fee, but instead “encourages” a dispensing fee. Commercial payers and Medicaid programs are expected to cover oral therapeutics under the pharmacy benefit and dispensing fee reimbursement may vary. The government has not required payers to cover oral products at all pharmacies and normal in-network limitations may apply.

Thus far, it appears that Part D Plans/PBMs are NOT providing reasonable reimbursement to pharmacies as evidenced by NCPA’s letter to CMS on January 18, 2022.

PAAS Tips:

New OTC COVID-19 Resources for Community Pharmacies

On February 2, PAAS National® announced new COVID-19 resources for PAAS Audit Assistance members to aid in billing commercial third-parties for OTC COVID-19 tests.

Members can access these tools, day supply charts, on demand webinars and more by logging into the PAAS Member Portal.

Not a member but interested in accessing COVID-19 tools available to you, click here. For member only tools call (608) 873-1342 to join today!

Caremark® Expands “Aberrant” Language & Restricts Bulk Purchases

As mentioned in PAAS’ December 2021 Newsline article about PBM provider manual updates, Caremark® traditionally mails a paper hardcopy of their full provider manual on even years, and only amendments on odd years. With 2022 being an even year, contracted pharmacies should have received a full paper copy of the 2022 provider manual.

In the 2020 Caremark® Provider Manual, section 3.02.03 was dedicated to explaining a provider’s obligation to not dispense aberrant quantities and volumes. Pharmacies are likely aware of the aberrant products list and Caremark’s arbitrary threshold of 25% (by dollar amount or number of Caremark® claims) which pharmacies were not allowed to exceed. Found within the same section in the 2022 manual, “Aberrant Quantities and Volumes” has been expanded and retitled to “Aberrant Practices and Trends”. The updated section title encompasses the five aberrant practices and trends for which Caremark® providers must not engage. In regards to the aberrant quantities and volume restrictions, Caremark® added language which goes beyond billing.

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Though the language in the manual was recently added, Caremark® has pursued these additional “aberrant practices” in the past. PAAS National® analysts have assisted pharmacies with audits which targeted claims billed for higher-cost medications (medications which had less expensive, more widely prescribed, equivalents from within the same therapeutic class). Caremark® has targeted pharmacies suspected of “fishing” for medications with the highest possible reimbursement rate, a practice which may easily trigger an audit due to the rapid adjudication and subsequent reversal of various medications within the same therapeutic class. These practices are formally listed as activities which may lead to claim chargebacks, Caremark® enforced remedies, and even contract termination.

Another section to be familiar with is section 8.05 which discusses bulk purchases. Anyone who has been through an invoice audit knows the importance of having enough purchased quantity (quantity “in”) to cover all the claims billed (quantity “out”) during the specified audit date range. Invoices from outside the audit date range may or may not be accepted depending on how far outside the audited date range the additional invoices are from and depending on the PBM. The 2022 Caremark® Provider Manual states that invoices from the audit date range, plus an additional 30 days prior to the listed range, must have sufficient product to cover all claims billed within the specified range. Caremark® states they will not count purchases from more than 30 days outside the audit date range toward product “in” unless the pharmacy previously notified Caremark® of these “bulk purchases” first by sending written request via mail within seven days prior to the purchase and Caremark® responds with a written approval. The postal address to which these requests must be sent can be found within section 8.05. The ridiculous process and audacity for such an anticompetitive policy is not lost on PAAS. We suspect there will be legal challenges to this language in the future. In the meantime, be cognizant of the requirement and consider flooding Caremark with “bulk purchase” requests.

PAAS Tips:

  • Familiarize yourself with the aberrant practices and trends Caremark® lays out within section 3.02.03 of their provider manual
    • Consider proactively adjust pharmacy practices (if necessary) to decrease the risk of an audit and potential contract termination
      • It is more difficult to adapt your business after a breach notice has been issued without further violating the Provider Agreement
    • Pharmacies must have a valid prescription for every claim billed; do not bill “test” claims
      • Different medications billed/reversed in quick succession with the same prescription number are an easy red flag for PBMs and auditors
    • Avoid unnecessary therapeutic substitutions to higher cost, less frequently prescribed, medications
    • If a substitution to a higher-costing medication is warranted, consider documenting the rationale
    • Refer to the full, paper copy of the manual or log in to the Caremark® Pharmacy Provider website (click on Document Library and scroll down until you find the 2022 manual) to read the complete text from the sections referenced above
    • If your pharmacy receives a breach notification, immediately send it to PAAS for guidance
  • Bulk purchases (i.e., purchases for a quantity covering more than a 30 day’ supply) may not count toward product “in” for a Caremark® invoice audit unless Caremark® first approves the pharmacy’s written request

Transfer Prescriptions Continue to Be Targeted

Transferred prescriptions remain a common audit target, and pharmacies are facing recoupments due to missing information. Without having all required elements set in place by your state’s Board of Pharmacy, these claims are at risk of full recoupment by PBMs. Transferred prescriptions are easily identified and audited by the PBM due to the origin code.

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Pharmacies receiving a faxed document from another pharmacy for a transfer must ensure all transfer requirements are included. If any requirements are missing (e.g., including the word “transfer” in some cases), the pharmacy must verify and add the information. Relying on another pharmacy to include all transfer requirements is extremely risky and could result in audit recoupments. Be aware, some states require transferred prescriptions be “reduced to writing.” PBMs like Humana have recouped claims in these states when a faxed form was used.

When PBMs like Humana, OptumRx, and Elixir flag a transferred prescription discrepant, they not only go after that claim, but all the refills under that prescription as well. Very quickly a small error can result in thousands of dollars facing recoupment.

Another way transferred prescriptions present audit risk is the invalid entry of the written date. If the receiving pharmacy fails to enter the actual written date of the prescription, the pharmacy could potentially refill past expiration. Make sure your staff is aware of the importance of entering accurate dates. PBMs are also flagging transferred insulin prescriptions if the quantity does not indicate a unit of measure (i.e., mL, pens, boxes or units).

PAAS Tips:

  • Check your state’s Board of Pharmacy transfer requirements and have printed for reference
  • Educate all staff on your state’s prescription transfer requirements
  • Pre-printed prescription pads with all your state’s transfer requirements can be very beneficial
  • Pharmacies using an internal transfer screen to capture the requirements must include this during an audit
  • See the Newsline’s Self-Audit Series #6 for monitoring your transfers internally

Self-Audit Series #12: Invoice Audits

PBMs have dramatically increased the number of invoice audits conducted and some pharmacies continue to be at risk for significant financial recoupments and contract terminations. It is not uncommon for invoice audit results to exceed six figures. To reduce the risk of your pharmacy having problems during a PBM invoice audit, consider performing a mock audit on your practice. The PBM is simply comparing the “ins” and “outs” of your pharmacy inventory for a specific period. If your “ins” are less than your “outs” for the PBM auditing, they conclude you have a shortage and will initiate recoupment. The “ins” are your acquisitions, or purchases, from wholesalers, manufacturers, trade shows or other pharmacies (note: there is no accounting for inventory on-hand). The “outs” are the claims that you billed to the PBM conducting the audit as well as any returns. The PBM already has the billed claims for the defined window, so when they initiate the invoice audit, they’re typically just in need of your purchasing history. Several PBMs, including OptumRx®, Elixir®, and Express Scripts® may even require the pharmacy to submit a full dispensing history for further reconciliation. Follow the tips below to reduce the risk of your pharmacy having problems during a PBM invoice audit.

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PAAS Tips:

  • Create and maintain a list of all wholesalers from who you purchased prescription, over-the-counter (OTC) and supply items that are billed to third parties
  • Verify that wholesalers are licensed in your state, National Association of Boards of Pharmacy (NABP)  Drug Distributor accredited, and can provide pedigrees in accordance with FDA Track and Trace Law
    • OptumRx requires network pharmacies source both prescription and OTC products from a supplier that is a licensed drug wholesaler in your state AND meets accreditation
    • Caremark and Express Scripts both require network pharmacies only purchase diabetic supplies from suppliers that are identified as “authorized distributors” by the manufacturers. Please refer to the July 2021 Newsline article, Life Scan Hires Law Firm to Pursue Pharmacies Purchasing from Unauthorized Distributors for manufacturer links to their authorized distributor lists.
  • Bulk purchases made outside the invoice audit date range are not always accepted by the PBM to account for additional inventory
    • CVS Caremark’s 2022 Provider Manual explicitly calls out bulk purchases of more than 30 days of inventory need to be preapproved, in writing [PAAS views the requirement as absurd and strongly opposes it]
  • Limit or eliminate the amount of inventory acquired from other pharmacies
    • If you must purchase inventory from another pharmacy, be aware of Drug Supply Chain Security Act (DSCSA) exceptions and keep good records of inventory acquisition, including proof of payment
  • Retain access to invoices and proof of payment for 10 years to coincide with Medicare Part D record retention requirements
  • Bill accurate NDC on all claims – all 11 digits are important
  • Bill accurate quantity on all claims – call PAAS National® (608) 873-1342 if unsure about billing unit or package size
  • Check your will-call bins to ensure that you are adhering to your Return to Stock (RTS) Policy, reverse any claims that are exceeding PBM limits
  • Verify that pharmacy management software has products marked as “active” only if you have physical product on the shelf to reduce data entry errors
  • Read the Self-Audit Series #12: Invoice Audit  Newsline article from January 2020 on how to perform a self-audit on invoices
  • See our Self-Audit Mindset document available on our portal for additional guidance

Common Claim Denials for Medicare Part B

In the PAAS National® August 2019 Newsline article, Medicare Part B/DMEPOS Audits – Who are All These Contractors?, we explained that Medicare and Medicaid use a number of audit contractors to perform medical review audits on pharmacies. The three main contractors PAAS sees carrying out these audits are: DME Medicare Administrative Contractors (MACs), Recovery Audit Contractors (RACs) and Supplemental Medical Review Contractors (SMRCs).

Many of the denied claims are due to not meeting medical necessity, frequency limitations, lacking supporting medical records and even basic coding mistakes. See PAAS Tips for links on billing specific DMEPOS items and required documentation for Medicare Part B claims.

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  • General reasons for claim denials on any audit:
    • Date of service and date of delivery do not match
    • Missing proof of refill request
    • Medical records are not signed by the physician
  • Glucose Meter Testing strips
    • Patient is testing outside guidelines and medical records do not support a valid reason why
    • No testing logs to prove patient is testing outside guidelines
    • Wrong modifier attached to claim based on insulin-dependent and non-insulin dependent
  • Immunosuppressive drugs
    • Not a covered transplant = must be kidney, heart, liver, bone marrow/stem cell, lung, intestinal and pancreas (limited situations)
    • Transplant was not performed in a Medicare approved facility
    • Missing transplant date and/or location
    • Patient was not enrolled in Medicare A at the time of transplant
  • Therapeutic Shoes
    • Missing medical records all together
    • Medical records do not support one or more of the qualifying conditions listed on the certifying statement
    • Missing in-person evaluation of the patient’s feet conducted by the supplier prior to ordering including measurements and deformities
    • Foot examination performed by the supplier does not contain an objective in-person assessment of the patient wearing the shoes/inserts

PAAS Tips:

Manipulating Quantity or Days’ Supply to Bypass Plan Limits Will Cost You

Plan limit rejections are intended to help control costs, provide clinical edits, and assist pharmacies in ensuring patient safety. When an initial claim adjudication is rejected for exceeding plan limits (e.g., Max Quantity Limit or Quantity vs Time Limit), pharmacies need to proceed with caution. An order entry technician that subsequently rebills for a different quantity [and same days’ supply] or the same quantity [and different days’ supply] than originally submitted, is asking for that prescription to be audited. PBM analytics assume the original adjudication was submitted and rejected [accurately] and when a subsequent claim [typically within seconds] has an altered quantity or days’ supply, it’s suspected that the manipulation was done [inappropriately] to get a paid claim. How should pharmacies proceed?

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When rejections like these happen, pharmacies need to pay close attention to any messages given on how to resolve the rejection, including calling the PBM help desk for an override or getting a prior authorization started with the prescriber. The prescriber could also decide to change the dose or prescribe an alternative medication.

Some examples of the INCORRECT way to handle rejections that have led to audits and recoupments:

  1. Test strips, #350 strips, with directions to “use up to 9x daily as needed.” The pharmacy received a rejection stating the plan only covers up to 8x daily. The claim was reprocessed for #350 strips for an incorrect 44-day supply resulting in potential recoupment for bypassing the plan limit.
  2. Oxycontin 30 mg, #90 tablets, with directions to “take 1 tablet 3x daily.” Plan limit rejection received for “Maximum 2 tablets per day”. The pharmacy reduced the quantity to #60 tablets and billed an incorrect 30-day supply resulting in potential recoupment for bypassing the plan limit.

What happens if a prescriber refuses to obtain a prior authorization or change the prescription to a clinically appropriate dose? Can the claim be split-billed? PAAS National® recommends against split billing or processing a claim as cash to circumvent a plan limit or prior authorization requirement. A doctor who refuses to obtain a prior authorization or change the dose could be a red flag for diversion with controlled substances. Remember that most plan limits are put in place based on appropriate clinical use and bypassing them can lead to overdoses, diversion, and/or death. Pharmacists have a corresponding responsibility to ensure that prescriptions are for legitimate medical purposes, especially for controlled substances (21 CFR 1306.04(a)).

PAAS Tips:

  • Always bill for the accurate days’ supply based on the quantity and the directions given on the prescription
  • Educate all pharmacy staff to identify rejection messages, how to properly resolve them, and to never purposely input the incorrect days’ supply or quantity to get a paid claim
  • Obtaining a prior authorization can often resolve the problem for six months to a year
    • Alternatively, the prescriber could send a new prescription [or verbally authorize] for a clinically appropriate dose or change in medication
    • Prescribers that are unwilling to obtain prior authorization or to change the prescription to a clinically appropriate dose may be a red flag for diversion with controlled substances
  • You may need to call the PBM help desk for assistance processing a claim or obtaining a proper override
  • Any DUR verifications, especially if using “M0” (prescriber consulted) to override the DUR, should have supporting documentation on the prescription or within retrievable electronic records
    • Use a proper clinical note when speaking with the prescriber’s office or help desk which includes the date, name and title of who you spoke with, what was discussed, and pharmacy staff initials
  • Do not split bill rejected claims
    • Charging the patient cash often leads to complaints [from the patient to an employer or PBM] and can be considered non-compliance with the provider manual and lead to remediation, including potential network termination
    • If you have exhausted all plan options and the patient insists on paying cash for the full prescription, be sure that you document authorization from the patient that they desire to pay the full cost and will not seek reimbursement from the insurance. This may protect you from accusations of non-compliance
  • Don’t be afraid to enlist the patient’s help. Having them file a complaint with their insurance can help expediate the prior authorization approval process

Bill It Right: V-Go® Insulin Delivery Device and Rapid Acting Insulin Vials

The Valeritas V-Go® Insulin Delivery Device (V-Go®), a disposable insulin delivery device, can be challenging to bill properly. Filling an order for V-Go® requires two separate prescriptions – the V-Go® delivery device and the rapid-acting insulin to be used within the V-Go® system.

Each box of V-Go® contains 30 single-use devices, each to be used over a 24-hour period and subsequently disposed of. Therefore, a single box should be billed as “30 each” for a 30-day supply. Due to the device being single-use only, it does not meet the Medicare Part B DME requirement of ability for repeated use and therefore should be billed as part of a patient’s Medicare Part D plan. V-Go® is a basal-bolus insulin delivery device, meaning it is able to deliver both a continuous basal level of insulin over a 24-hour period in addition to bolus dosing for meals. It comes in three dosing selections based off the basal level of insulin the patient requires – 20 units/24 hours (V-Go® 20), 30 units/24 hours (V-Go® 30), and 40 units/24 hours (V-Go® 40) – plus a maximum of an additional 36 units to be used for bolus dosing, dosed in 2-unit increments. In addition, the manufacturer requires each V-Go® be filled to capacity and after 24 hours what insulin is left in the device must be disposed of. Due to the maximum amount of units each device can hold and the inability to salvage any leftover insulin in the V-Go® delivery system after 24 hours, it calls for the prescriber to meticulously determine which V-Go® device is most appropriate for the patient.

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The second prescription to consider is the insulin to be used along with the V-Go® system. Both insulin lispro injection (Humalog® U-100) and insulin aspart injection (Novolog® 100 units/mL) have been tested and approved for use within V-Go® delivery devices. Note that concentrated insulins and insulin pens are not designed for use with the V-Go® delivery system. As previously stated, each of the three V-Go® dosing selections have different maximum insulin units the device can provide each day, and since the reservoir must be filled to its maximum capacity, that maximum number of units should be used in calculating the correct days’ supply. For example, 1 vial of insulin (1000 units) used in a V-Go® 20 device, divided by a maximum 56 units per day (1000/56), equates to a 17 days’ supply. The chart below depicts additional device and vial combinations:

V-Go® Device Max Insulin Units Delivered Per Day Estimated Days’ Supply
1 vial 2 vials 3 vials
V-Go® 20 56 units 17 35 53
V-Go® 30 66 units 15 30 45
V-Go® 40 76 units 13 26 3

When determining the proper amount of vials to dispense, follow the guidance provided in the Can You Bill It As 30 Days? and Diabetic Injectables FAQ documents, found on PAAS Member Portal located on the Tools and Aids page, to ensure proper billing practices in case of audit.

PAAS Tips:

  • Per package labeling, V-Go® is to be dispensed as one kit and is unable to be broken
  • If a patient reports either a V-Go® or EZ Fill device is missing or damaged, replacement items may be requested from a V-Go® Customer Care Representative at 1-866-881-1209
  • For additional information pertaining to V-Go® billing, see the February 2019 Newsline article, Bill It Right! V-Go® Insulin Delivery Device and Insulin Vials

Top Medications Flagged for Unauthorized Substitutions

PAAS National® analysts have repeatedly seen auditors targeting claims with potentially undocumented substitution issues. They hope to find inappropriate substitutions which may result in recoupment of the claim. To decrease the risk of these recoupments, and better understand where the issue stems, let’s start with a bit of background information.

Since 1938, when a company seeks authorization for a new (non-biologic) drug, they must compile enough evidence for the U.S. Food and Drug Administration (FDA) to determine if the product will be approved for sale in the United States—this packet of information is referred to as the New Drug Application (NDA). Generally, the drug with the NDA becomes the reference listed drug (RLD, or brand-name) product. The RLD is what other companies’ reference when seeking approval for their equivalent product (or generic) through the Abbreviated New Drug Application (ANDA). The ANDA must provide the FDA with evidence that the product is equivalent to the FDA-identified RLD and must show in vivo bioequivalence to the reference standard (RS) drug product. The FDA usually selects one RS and generally it is the RLD, but in some cases they are different.  If the FDA has enough evidence to establish equivalency, when the ANDA generic is approved, it will be given an “AB” rating. Each ANDA must list a single RLD to which it is being compared and if the FDA did not set the RLD, an ANDA applicant must ask the Office of Generic Drugs to designate one. When different RLDs are utilized for the same drug product of the same strength by different companies on their ANDA, it creates the need for a three-character Therapeutic Equivalency (TE) code (e.g., AB1, AB2, AB3, etc.). Only drug products with the same three-character TE code which are listed under the same active ingredient heading can be freely substituted for each other, plus the authorized generic, unless prohibited by state regulation. Be aware that authorized generics do not appear in the Orange Book and are not evaluated by the FDA for an equivalency rating because they are the same products as their RLD, or brand-name drug, however, they do not use the brand name.

If, at this time, the FDA considers a product to not be therapeutically equivalent, it will assign it a “B” rating. Claims at risk for recoupment include those where the prescription was issued for a specific RLD (brand-name) but filled with a non-matching TE code product or those filled with a B-rated product. The FDA Orange Book can be accessed online and may be utilized to confirm equivalency for non-biologic drug products to prevent these recoupments.

Anyone unfamiliar with the Orange Book can read the Preface which contains very detailed explanations of how to use the book as well as the meaning of each code. Included is an example of the three-character TE code system using nifedipine. Adalat® CC and Procardia XL® extended-release tablets are both listed under the same active ingredient (nifedipine) heading. Adalat® CC is designated AB1 and Procardia XL® AB2. ANDA generics approved with Adalat® CC listed as the RLD would receive an AB1 rating, and those approved with the RLD Procardia XL®, AB2. To substitute an AB1-coded generic nifedipine extended-release tablet for Procardia XL® without contacting the prescriber would be inappropriate and the claim could face recoupment if audited.

Based on the observations of PAAS analysts, the following table contains the most common products incorrectly substituted with non-AB rated products, and subsequently flagged upon audit:

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Active Ingredient Heading Dosage Form Possible Equivalency Codes Most Commonly Flagged Medications due to Undocumented Substitution PAAS Newsline Articles with Additional Info
Albuterol HFA aerosol inhaler AB1, AB2, BX Proventil®, ProAir®, Ventolin®, non-equivalent generic albuterol June 2020 – First AB-Rated Generic for Proventil® Approved
Epinephrine Autoinjector AB, BX EpiPen®, non-equivalent generic epinephrine
Isotretinoin Capsule AB1, AB2 ClaravisTM, Amnesteem®, Myorisan®, ZenataneTM, Absorica®, non-equivalent generic isotretinoin May 2021 – iPLEDGE® Requirements and Isotretinoin Therapeutic Equivalence Products Reminder
Methylphenidate ER tablets & ER capsules AB, AB1, AB2, AB3, BX Concerta®, Methylin ER, Ritalin LA®, Metadate CD®, Aptensio XRTM, non-equivalent generic methylphenidate ER November 2020 – Best Practices for Methylphenidate ER Substitution

PAAS Tips: