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:

Would Your Spravato® Documentation PAAS an Audit?

Spravato® is a Schedule III controlled substance intranasal spray used in conjunction with an oral antidepressant for treatment-resistant depression in adults. It is part of the Risk Evaluation and Mitigation Strategy (REMS) Program and can only be dispensed and administered to patients in a REMS certified healthcare setting due to the risks of sedation, misuse, and abuse. PAAS National® alerted members in a February 2021 Newsline article How to Avoid Spravato® Audit Recoupments that we have seen attempted audit recoupments for Spravato® due to the pharmacy being unable to provide record of shipment received and dispensing information (including patient name, dose, number of devices, and date dispensed) per REMS guidelines. PBMs currently auditing Spravato® prescriptions include Elixir, MedImpact, Humana and Pharmacy Data Management, Inc. (PDMI.)

PAAS Tips:

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  • Pharmacies that dispense Spravato® must:
    • Become certified: Have an authorized representative complete the certification process and monitor compliance with the REMS Program
    • Have policies and procedures in place to verify that a healthcare setting is also certified in the REMS Program prior to dispensing Spravato®
    • Be sure to train pharmacy staff that Spravato® can only be dispensed to a certified healthcare setting
    • Maintain records for proof of pharmacy employee training and that policies and procedures are in place and being followed
    • Maintain records of all shipments of Spravato® received and dispensing information including patient name, dose, number of devices dispensed and the date of the dispensing
    • Ensure proper documentation of dispensing to a certified healthcare setting occurs:
      • Need the name, address, and phone number of the doctor’s office
      • Need the printed name, title, signature, and date of the representative receiving the order
      • Need patient name, dose, number of devices dispensed and the date of the dispensing
    • Maintain records of all deliveries of Spravato®
  • Spravato® is intended for the patient to administer under the supervision of a healthcare professional
  • See our November 2019 Newsline article, Spravato® – Watch the Billing!,  for proper billing information, including package size and billing units

Webinar: PBM FWA Trends and COVID-19 Vaccine Audit Risks

On November 18, 2021 PAAS National® hosted PBM FWA Trends and COVID-19 Vaccine Audit Risks webinar. PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Portal.

This webinar reviews:

  • PBM Fraud, Waste and Abuse (FWA) Trends
  • COVID-19 Vaccine Audit Risks
    • Documentation Requirements
    • Additional Doses for Immunocompromised
    • Booster Doses for qualified patients
    • Medicare at-home patients
  • Pandemic related PBM waivers/concessions

Don’t Jump the Gun: Refill Too Soon Recoupments

Pharmacies know the importance of billing accurate days’ supply on prescriptions; however, there may be circumstances that can make this challenging. Medications that only come in one size or an unbreakable package may exceed what the patient will use during the plan limit timeframe. Claims dispensed for a plan limit, but the true day’s supply is greater, are an easy target for refilling too soon.

Pharmacies must be diligent in monitoring refills for claims submitted for a plan limit but will last the patient longer. The PBM only sees the days’ supply submitted on the claim. Once a prescription is audited, the directions for use will reveal the true days’ supply.

These claims are an easy target for audit as the PBM already received the initial/rejected claim days’ supply (suspected as the true days’ supply) and a subsequent claim with a shortened days’ supply (to meet plan limits). Based on this information, the PBM will audit subsequent refill too soon occurrences with a high margin of success.

Examples of prescriptions that pharmacies may need to dispense over the plan limit

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include insulin, inhalers, eye drops, topicals and diabetic test strips. Since many of these come in one size and are considered an unbreakable package, the pharmacy may be forced to submit as a plan limit.

Here is an example of a pharmacy putting claims at risk for refilling too soon:

  • Prescription for 1 box of insulin pens with instructions that would last 34 days
  • Pharmacy ran the claim for the plan max of 30 days
  • Pharmacy refilled the prescription 23 days later
  • PBM paid claim because the adjudicated claim indicated a 30 days’ supply
  • Percentage of use of the actual days’ supply was only 68%

As you can see, adjusting the days’ supply by 4 days (to meet the plan limit) put a claim in jeopardy of refilling too soon.

PAAS Tips:

  • Always submit claims with accurate days’ supply first, many PBMs now have built-in overrides in place for smallest package sizes
  • Use smallest package size available when days’ supply exceeds plan limit
  • See our Can You Bill It As 30 Days? under our Tools & Aids section of the PAAS Member Portal
  • Utilize our Days Supply Charts and have them easily accessible for data entry staff to assist with accurate calculations
  • Self-audit prescriptions by running internal audits on high-risk prescriptions for days’ supply and refill accuracy;  see our Self-Audit Series of articles in our archive on the PAAS Member Portal
  • Include notation on patient label to help notify patient and pharmacy staff of true days’ supply
  • Check with software vendor to see if additional days’ supply fields are available for internal tracking

Beware: Same Ingredients, Different FDA Indications

Ozempic® is an injectable diabetic medicine used to improve glycemic control in adults for type 2 diabetes management. Please see our May 2021 Newsline New Package Size Available for Ozempic® for reference on how to bill for Ozempic®. On June 4, 2021, the FDA approved a new drug treatment for chronic weight management called Wegovy™ which has the exact same ingredient – semaglutide.

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Similarly, Victoza® is also used to improve glycemic control in patients 10 years and older for type 2 diabetes and is composed of an ingredient called liraglutide. Saxenda® also contains liraglutide but is used for chronic weight management. Pharmacies need to be aware that there is an audit risk if the prescriber is ordering for off-label use.

GLP-1 Receptor Agonist Analog Name FDA Indication Goal Dose
Ozempic® semaglutide Type 2 diabetes management 0.5 mg or 1 mg weekly
Wegovy™ semaglutide Chronic weight management 2.4 mg weekly
Victoza® liraglutide Type 2 diabetes management 1.2 mg or 1.8 mg daily
Saxenda® liraglutide Chronic weight management 3 mg daily

PAAS Tips:

  • Prescribers may try to help patients get around plan exclusions for weight loss medications by prescribing Ozempic® or Victoza® at higher doses
    • FDA approved medications being used off-label like this would likely not be covered under federal programs and are subject to audit recoupment
    • Claims paid at point-of-sale do not guarantee payment
  • If a prescription is written for the Analog name, pharmacies need to confirm the diagnosis to bill the correct medication
  • These products come in multiple strengths and package sizes which would also need to be confirmed
  • Medicare Part D and Medicaid may restrict coverage of medications if the prescribed use is not for a medically accepted indication

PBM Provider Manual Updates – What You Need to Know

Pharmacy Benefit Managers (PBMs) update their provider manuals on occasion (some more frequently than others) and although the changes are applicable to the practice of all pharmacies contracted with that PBM, it can be difficult to keep track of the method by which each PBM updates their manual and where to find it.

  • Caremark – Generally they mail out a paper, hardcopy of their provider manual to contracted pharmacies every other year, on even years, and amendments on odd years. An electronic copy can also be found at the bottom of the Document Library on the pharmacy provider website (log in required).
  • Express Scripts® updates their manual and posts the newest version online in the Pharmacist Resource Center (log in required) along with an itemized list of updates. Pharmacy staff can read the itemized list if they are looking for an efficient way to access and review the updates.
  • Humana – Their provider manual is publicly accessible via the Pharmacy Manuals and Forms page of their website, which affords all pharmacies quick and easy access to the relevant information.
  • OptumRx® updates their provider manual multiples times each year. The newest being Version 4.1 which was published at the being of October 2021. The provider manual for OptumRx® is publicly available under the Manuals and Guides sections of the Health Care Professionals website. However, OptumRx® does not provide a summary of changes or a quick reference guide. Below are several significant updates from recent versions of their provider manual.

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    • Contracted pharmacies must provide language interpreter services in accordance with their state’s requirements or regulations.
    • Examples of “computer records” are now included under desktop and telephone audits and investigational reviews; these examples include electronic prescriptions (new and refill authorizations) as well as electronically stored clarifications or notes.
    • Over the course of 2021 several major additions have been made to the discrepancy code list:
      • 1P and 4B – Previously, claims billed with an invalid prescriber DEA number received these codes. Now, they will be utilized for invalid NPI number as well.
      • 2L – This discrepancy has been utilized when a script was missing documentation to validate the clinical appropriateness on a claim with possible clinical issues (gender/age/drug). Now, it will also be used for “possible high dose” claims without documentation supporting the appropriateness of the dose.
      • 3B – This will be utilized on claims with missing or invalid Risk Evaluation & Mitigation Strategies (REMS) documentation. For additional REMS information, refer to the June 2021 Newsline article Would Your REMS Prescription Pass an Audit?
      • 4Q – In states where prescriptions issued by mid-level practitioners require information regarding the supervising doctor, this code will be used if the supervisor’s information is missing.

 

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PAAS Tips:

  • It is important to stay up to date on the requirements of each PBM you are contracted with
  • Becoming familiar with a PBMs pharmacy provider manual can help the pharmacy prevent recoupment when audited and remain proactive by ensuring pharmacy policies and procedures are in line with PBM requirements
  • If your pharmacy receives a PBM notification regarding a policy change, please forward the notice to PAAS National® via fax (608) 873-4009 or email info@paasnational.com

Bill it Right: AndroGel® Pump 88 g vs 75 g

Pharmacies have recently reported receiving telephone calls from Caremark’s audit department regarding claims for AndroGel® (testosterone) pump (and generics) related to incorrect package size billed. Pharmacies submitted 88 grams as indicated on the wholesaler ordering website and listed on the outside of the manufacturer’s packaging, but Caremark representatives stated that 75 grams is the correct package size. Pharmacies subsequently contacted PAAS National®, concerned that Caremark was trying to underpay them for these products.

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The correct billing unit as defined by NCPDP is 75 g. See further discussion below for more details.

According to the AndroGel® product labeling, Section 16 How Supplied/Storage and Handling

Each 88 g metered-dose pump is capable of dispensing 75 g of gel or 60 metered pump actuations; each pump actuation dispenses 1.25 g of gel.

Additionally, NCPDP (the organization that sets the industry standards for how drugs are billed) has posted QUIC Form Resolutions where participants such as manufacturers, payers, processors and providers can submit requests to NCPDP for discussion and clarification about certain products.

Here is the resolution from May 2011 NCPDP Workgroup 2 Meeting discussing AndroGel® Pump

Requested clarification for the billing unit quantity. At the May 2011 WG2 meeting the form was discussed. Issue: Clarification is requested regarding the billing quantity for AndroGel 1.62% metered-dose pump. The outer packaging and product label state “Total contents: 88 g.” The labels also state “Multi-dose pump capable of dispensing 60 metered pump actuations” and “each actuation delivers 1.25 g of gel.”  Based upon the latter statements, the pump is capable of delivering 75 g of gel.  Is the billing quantity 88 or 75?

Discussion: There was discussion on Androgel. There is a new strength of Androgel at 1.62 %. The label shows 88 grams but it only delivers 75 grams. The compendia have it listed differently and they need to be consistent. This product came out May 4th. It is anticipated that the compendia will coordinate the change to 75 grams at the end of the quarter. (note, subsequent to the meeting it was noted that all compendia changed the package size to 75 grams before the end of the quarter as the product was just launched).

Post WG Meeting Note: The Product Review and Billing Unit Exceptions Task Group discussed on their call of May 24th and it was agreed that 75 grams should be the package size.

PAAS Tips:

  • Wholesaler ordering websites may not list products in the same NCPDP billing unit or package size
  • A similar product that has unusual billing is CellCept® Oral Suspension (and generics) that list 175 mL on the outer packaging but only delivers 160-165 mL after reconstitution. NCPDP defines billing as 160 mL.
  • If you need help determining the appropriate billing quantity or unit of measure, please contact PAAS for assistance
    • If the patient is waiting at the pharmacy, please call PAAS at (608) 873-1342
    • If the patient is coming back at a later time, you can also send a question through the PAAS Portal under Questions? Safe Filling and Billing Advice

Update: Medicare Part D Mandatory e-Prescribing Requirements

In our February 2021 Newsline article, PAAS alerted pharmacies to the delay in enforcement of Electronic Prescriptions for Controlled Substances (EPCS) for Medicare Part D until January 1, 2022. As this new deadline approaches, CMS is once again considering extending compliance actions to January 1, 2023. While no decision on the extension has been made yet, pharmacies can find the proposed rule at https://www.federalregister.gov/documents/2021/07/23/2021-14973/medicare-program-cy-2022-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part.

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Once EPCS in Medicare Part D becomes mandatory, there are likely to be many exceptions where e-prescribing may be waived. As of January 19, 2021, sixteen states had already implemented their own EPCS requirements with twelve additional states looking to implement ECPS requirements by the end of 2021. What does this mean for pharmacy audits?

State required EPCS has been around for many years, going back as far as 2013 in New York state, and each state has laid out prescriber exceptions to the requirement, and in most cases, the pharmacy is not responsible for knowing if the prescriber has an exception in place. It is a good idea to check with your Board of Pharmacy if you are unsure of your state’s current EPCS requirements and exceptions.

Centene® – Why Are They Leaving the PBM Game?

Founded in Wisconsin in 1984, Centene started as a nonprofit Medicaid plan and grew to become the nation’s largest Medicaid managed care organization serving over 26 million managed care members. Nearly 1 in 15 people in America have services through Centene, including Medicaid, Medicare, the Health Insurance Marketplace, TRICARE, and correctional facilities.

At the end of October 2021, Centene® executives said the company would be making a $30 billion request for proposals from outside contractors to take over the pharmacy benefit manager (PBM) side of their business. The request for proposal is expected to launch in 2022 and be awarded in 2023. Estimates show PBMs make $400 billion a year nationwide, so why would Centene® decide to divest such a lucrative part of their business?

Centene® reasoned that managing pharmacy benefits was simply not among its core functions. While not stated, the entanglement in several legal battles surely plays a role. The Ohio Attorney General, Dave Yost, filed suit against Centene® in March 2021. The Attorney General accused Centene® of using multiple PBMs to perform the same functions and overbilling taxpayers tens of millions of dollars. The Ohio Medicaid plan managed by Centene®, Buckeye Health Plan™, had hired Envolve™ (a Centene® subsidiary) to handle pharmacy benefits. Envolve™ then hired Health Net™ Pharmacy Solutions (another Centene® subsidiary) which contracted with CVS Caremark®. Centene® claims CVS Caremark® only handled claims payment processing while Envolve™ did everything else, including, specialty management, data analytics, drug utilization review, and formulary management; however, CVS Caremark® contradicted this. Talk about a tangled web of PBM opaqueness!

Centene® was also accused of pocketing dispensing fees charged to the state and meant for pharmacies while these pharmacies had Medicaid reimbursement rates lower than the cost of dispensing. Centene® does not deny they pocketed $6.7 million in dispensing fees meant for pharmacies but has stated this practice was not prohibited by their contract and was entirely appropriate under their spread-pricing contract with Ohio’s Medicaid department.

While Centene® has not admitted wrongdoing, it has agreed to pay Ohio $88 million and set aside $1 billion to settle future potential suits. Kansas, Mississippi, Arkansas, Georgia, Oklahoma, New Mexico, and the District of Columbia are also taking a serious look into Centene®’s conduct.

Updated PAAS National® Dispense In Original Container Chart

Dispensing medications outside of FDA packaging requirements may put your claims at risk of recoupment. Medications sensitive to light and/or moisture may require pharmacies to dispense the medication in the original container. Product testing by the manufacturer will determine if this is required. This information will be listed in the product labeling section How Supplied/Storage and Handling. Because manufacturers submit this language to the FDA for approval, be aware there are inconsistencies in how this information appears for different products. Pharmacies can access this information from the package insert or the FDA’s DailyMed website (https://dailymed.nlm.nih.gov/dailymed/).

Prescription claims submitted to PBMs for an NDC that is required to be dispensed in the original container are an easy target for recoupment when the dispensed quantity does not match the package size. Pharmacies that cycle fill medications or service LTC facilities must be aware of these packaging requirements and dispense appropriately as well.

PAAS National® offers our members a chart of medications with special packaging requirements, see the Tools & Aids section of the PAAS Member Portal.

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The three additions to our chart include:

  1. Carafate® (Sucralfate) 1gm/10mL Suspension
  2. Rybelsus® 3 mg, 7 mg and 14 mg tablets
  3. Tabrecta™ 150 mg and 200 mg tablets

PAAS Tips:

  • Utilize the PAAS National® Dispense In Original Container Chart, by printing and posting the updated copy in your pharmacy
  • Consider adding special shelf tags to these medications to warn staff of their packaging requirements
  • Obtain authorization from prescribers if quantity prescribed is less than what the package size is
  • Self-audit claims that fall under these guidelines to ensure you are dispensing appropriately