Biosimilar Adoption for Humira in 2023

NCPA Multiple Locations Conference Panel Discussion Part 2 of 2

On February 25, 2023, President of PAAS National®, Trent Thiede, had the privilege of participating in a Panel Discussion entitled Marketplace Prescription Dynamics Sure to Shape Your Business Strategies. While traversing several different topic areas, there are two core issues that are important for PAAS members: discount/cash cards and biosimilar adoption in 2023. PAAS Audit Assistance members can see Discount/Cash Cards Are Disruptors in the Industry from our March Newsline.

While Semglee® was the first interchangeable biosimilar to market back in 2021, Humira has been grabbing attention because of its status as the pharma-GOAT: Greatest Of All Time (in terms of sales) as coined by Doug Hoey from NCPA. If you’re not familiar with the onslaught of biosimilars, reference this chart below from Cardinal Health’s biosimilar landscape overview. To summarize, there are 8 FDA approved biosimilars, and 5 more pending FDA approval. Cyltezo, which should be coming to market this summer, has been approved as an interchangeable biosimilar. Four additional products referenced are seeking interchangeability status.

FDA Approved

Product Company Estimated launch Concentration Seeking interchangeability Citrate free Latex free Needle size
Amjevita™ Amgen January 31, 2023 Low (50MG) No Yes Yes 29G Syr. / 27G Pen
Hadlima™ Organon July 1, 2023 Low (50MG) No No Yes 29G Syr. / 29G Pen
Cyltezo™ Boehringer
Ingelheim		 July 1, 2023 Low (50MG) Yes, Approved
October 18, 2021		 Yes No 27G Syr. / 27G Pen
Yusimry™ Coherus July 1, 2023 Low (50MG) No Yes Yes Unknown
Hulio™ Viatris July 31, 2023 Low (50MG) No Yes Yes 29G Syr. / 29G Pen
Hyrimoz™ Sandoz July 1, 2023 Low (50MG) No No No 27G Syr. / 27G Pen
Abrilada™ Pfizer November 20, 2023 Low (50MG) Yes Yes Yes 29G Syr. / 29G Pen
Idacio™ Fresenius Kabi September 30, 2023 Low (50MG) No Yes Yes 29G Syr. / 29G Pen

Pending Approval

Product Company Estimated launch Concentration Seeking interchangeability Citrate free Latex free Needle size
SB5-HC Organon July 1, 2023 High (100MG) Yes Yes Yes 29G Syr. / 29G Pen
AVT-02 Teva July 1, 2023 High (100MG) Yes Yes Yes Unknown
Yuflyma Celltrion July 1, 2023 High (100MG) No Yes Yes 29G Syr. / 29G Pen
ABP – 501 HC Amgen TBD High (100MG) Yes Yes No 29G Syr. / 27G Pen
Hyrimoz HCF Sandoz July 1, 2023 High (100MG) No Yes No 27G Syr. / 27G Pen

While Amjevita™ came to market in January, pharmacies need to be cognizant that it is a biosimilar but does not have interchangeability status. PAAS Audit Assistance members can see Biologic Drug Substitution in this month’s Newsline for additional information on biologic substitutions.

Biosimilar adoption relies, at least in part, on pharmacists. There was a report issued by Cardinal Health that identified > 60% of dermatologists, rheumatologists, and gastroenterologists would NOT feel comfortable prescribing a biosimilar if it did not have the interchangeability designation. Pharmacists can think of these biosimilars as alternative brands. There’s not likely to be great uptake in market share unless providers are aware and more willing to prescribe.

Additionally, OptumRx, Express Scripts and Prime Therapeutics are keeping Humira on formulary at parity with biosimilars, meaning patients won’t have a financial reason to switch. Why change to a biosimilar if you can continue to take Humira for no additional cost? Perhaps patients new to therapy could try a biosimilar first, but it seems to reason that adoption will be slow in 2023.

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  • Cyltezo is currently the only FDA approved interchangeable biosimilar for Humira (coming to market July of 2023)
  • Some large payers are keeping Humira on formulary for 2023, but other may not
    • Watch for soft-rejects alerting pharmacies to preferred biosimilars
    • PBMs may allow Humira to process, but severely underpay the claim
  • See PAAS’ Biologic Injectable Medication and Insulin Medication chart for interchangeable biosimilars
  • Use the FDA Purple Book as a resource for biosimilars and interchangeability

PerformRxSM Investigational Audits Are on the Rise

PAAS National® has recently seen a new trend with investigational audits completed by PerformRxSM. These audits are a combination of an invoice, desk, and a compliance audit. Pharmacies must obtain invoices for the requested date range, 25-60 prescriptions, signature logs and proof of copay collection for all refills.

This investigational audit also includes an extensive questionnaire. The questionnaire may have unique questions based on idiosyncrasies the PBM has identified for your pharmacy. Mailing and delivery procedures and automatic refill policies are just some of the questions pharmacies must address.

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We urge pharmacies to review their written Standard Operating Procedures (SOP) and Fraud, Waste, & Abuse Compliance Programs. Updates may be necessary to ensure your policies and procedures are compliant with current practice. The Onsite Credentialing Guidelines we have created is an excellent tool to prepare you for common questions PBMs may ask.

Remember to engage PAAS analysts early to ensure you have the most successful outcome.

PAAS Tips:

Looking for an FWA/HIPAA Compliance program? Schedule a service overview with PAAS National® today and learn how to get started on customizing your Policy and Procedure Manual. 

LifeScan Continues to Pursue Pharmacies Purchasing from Unauthorized Distributors

Test strip manufacturers sit in a unique position when it comes to monitoring nonprescription diabetic supply purchasing and dispensing. Manufacturers acquire purchase histories from authorized distributors regarding the volume of test strip products ordered by a pharmacy. Additionally, manufacturers can obtain information regarding the amount of test strip-associated rebates paid to PBMs by NCPDP number. With simple math, the manufacturer can identify when a pharmacy has not ordered diabetic test strips from a source they authorize.

This has occurred repeatedly with Lifescan, with recoupment demands last seen in 2021. Like previous communications, these letters are borderline extortionary – demanding payment in a short time and threatening to notify PBMs for non-compliance.

PAAS National® has assisted on numerous cases pertaining to test strip manufacturers (and PBMs) trying to recoup funds on the premise of pharmacies utilizing unauthorized distributors. PAAS can help your pharmacy further navigate the demand. If you’ve been contacted by LifeScan, be protected and contact PAAS (608) 873-1342 to get guidance and one-on-one support from a PAAS analyst.

LIVE WEBINAR MAY 4th: Audit Preparation for the End of the Public Health Emergency

Join President of PAAS National®, Trenton Thiede, PharmD, MBA for a LIVE webinar “Audit Preparation for the End of the Public Health Emergency ” on May 4, 2023 from 2-2:45pm CT as he discusses:

  • The anticipated Amendment to the Declaration under the PREP Act
  • Onsite audit preparations
  • Audit considerations with mailing and delivery medication
  • Elements for compliant delivery/signature logs
  • New Continuous Glucose Monitor (CGM) requirements that will affect Medicare B patients

We will allow for some Q&A at the end of the webinar. If you would like to submit questions prior to the webinar, please click here.

PAAS Audit Assistance members will have access to a recording on the PAAS Member Portal if they are unable to attend the live event.

REGISTER TODAY!

Best Practices: Medication Delivery

With the Public Health Emergency (PHE) for COVID-19 ending May 11, 2023, a return to pre-pandemic requirements for proving patient receipt of medications is anticipated. Many pharmacies have gotten into the habit of leaving medications at the door or in the mailbox for patients over the last three years and noting “Impacted by COVID-19” in place of a signature. Unfortunately, some pharmacies have run into problems with this procedure during audits due to patients deny ordering and/or receiving these medications. In some instances, the patient passed before the medications were delivered.

Review the PAAS Tips below to see what pharmacies can do to avoid audit problems when delivering medications.

PAAS Tips:

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  • Always obtain and document patient consent prior to delivery of any auto-refilled or synchronized medications and provide a minimum of two reminders before each fill. See Automatic Mailing for Part D Patients from our September 2022 Newsline.
  • Coordinate the delivery when the patient or a representative would be home to accept the delivery.
  • Use extra caution when delivering medications for controlled substances, especially if outside the norm or being requested by a different family member.
  • Do not leave medication at the door or in the mailbox without obtaining a signature.
  • Without getting a patient signature, you do not know if the patient actually received their medication.
  • A picture of the package at the front door does not prove what was inside the package, nor does it prove where the package was delivered without a geotag on the picture.
  • If the pharmacy and patient have agreed to the risks of leaving a package in a mailbox or at the front door, the pharmacy should include a PAAS Trifold Mailer with a detailed description of the medications delivered for the patient (recipient) to complete and mail back.
  • Signature logs for delivery should also include a handwritten date received.
  • Auditors interpret preprinted dates as the date the delivery manifest was generated, not necessarily the date of actual receipt by the patient.
  • Point of sale (POS) signature logs for delivery must be monitored to ensure the actual date of receipt is recorded. Work with your software vendor to know your system’s capabilities.
  • OptumRx only allows delivery by W-2 employees.
  • If delivering out of state, make sure you hold a non-resident pharmacy license for that state.
  • Read the February 2023 Newsline article, Are Your Delivery/Signature Logs PBM Compliant for 2023? for more information.

Prepare Yourselves! Onsite Audits Are Coming in Strong

Health and Human Services (HHS) is planning for the public health emergency (PHE) to expire on May 11, 2023 and PBM auditors are in full swing of resuming their onsite visits. Onsite audits have always been the most aggressive and highest risk to community pharmacies. PAAS National® saw a 300% increase in onsite audits in just the 3rd Quarter of 2022 and they continue to be on the rise! PAAS analysts have years of experience helping our members navigate through preparation for an onsite audit. We are available to assist you throughout your audit process starting with, How to Prepare for an Onsite Audit.

Your PAAS analyst can provide pre-audit consultations, helpful tips and tools, reminders on state law requirements, and discuss current PBM trends. Our Onsite Credentialing Guidelines document has been created specifically to help pharmacies be ready for questions the auditor may ask during their visit. This tool is updated frequently to provide members the most up to date information along with providing PAAS National® FWA/HIPAA Compliance members reference to locate specific policies in their customized FWA/HIPAA Compliance Policy & Procedure Manual.

PAAS Tips:

Contact PAAS National® (608) 873-1342 today to get your customized FWA/HIPAA compliance program! Or schedule a service overview of the program to see why it was designed to meet CMS’ seven core elements required to adopt and implement an effective compliance program.

A Documentation Checklist for Continuous Glucose Monitor Claims

For any item to be covered by Medicare B, there must be clinical documentation to support the covered diagnosis, prove it is reasonable and necessary for treatment and meet all other Medicare requirements. While the Local Coverage Determination (LCD) outlines billing and documentation requirements specific to each DMEPOS item, and the DME MACs created documentation checklists for each DMEPOS item, they tend to be verbose and difficult to read. Additionally, during the COVID-19 PHE, CMS expressed enforcement discretion on clinical indications for Continuous Glucose Monitors (CGM). Prescribers, and pharmacies, only needed to make sure the medical record reflected the equipment furnished to patients was reasonable and necessary. The LCD for CGMs was updated 3/2/2023 with an effective date of 4/16/2023, although the enforcement discretion seemingly coincides with the end of the PHE on 5/12/2023. The CGM checklist listed below can help suppliers in adhering to all of Medicare rules in simplified terms.

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  • CGM Initial Coverage Requirements – to be eligible for coverage of a CGM and related supplies, the beneficiary must meet all of the following initial coverage criteria (1) – (5);
  1. The beneficiary must have diabetes mellitus
  2. The beneficiary’s treating practitioner has concluded that the beneficiary or their caregiver has sufficient training using the CGM prescribed as evidenced by providing a prescription for the CGM
  3. The CGM is prescribed in accordance with FDA indications for use
  4. The beneficiary for whom a CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:
    1. The beneficiary is insulin treated
    2. The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following:
      1. Recurrent (more than one) level 2 hypoglycemic events (glucose <54 mg/dL (3.0 mmol/L)) that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or,
      2. A history of one level 3 hypoglycemic event (glucose <54 mg/dL (3.0 mmol/L)) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia
    3. Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person or Medicare-approved telehealth visit with the beneficiary to evaluate their diabetes control and determined that criteria (1)-(4) above are met.
  • CGM Continued Coverage Requirements – every six (6) months following the initial prescription for the CGM, the treating practitioner must have an in-person or Medicare-approved telehealth visit with the beneficiary to document compliance to their CGM and diabetes treatment plan.

If any of the initial coverage criteria (1)-(5), or the continued coverage criteria are not met, the CGM and related supply allowance will be denied. Claims for a Blood Glucose Monitor (BGM) and their related supplies that are billed in addition to a non-adjunctive CGM and supply allowance, will also be denied.

  • Medical Records

For a beneficiary who exceeds the usual utilization amounts of BGM supplies, there must be adequate information in their medical record to determine that:

  1. Treating practitioner has had an in-person or Medicare-approved telehealth visit to evaluate the management of diabetes
  2. The specific quantities of supplies ordered are reasonable and necessary
  3. Narrative statement that documents the frequency at which the beneficiary is testing or a copy of their testing logs

Medical records must support criteria (1-4) above regarding CGM initial coverage and (4B) – document the beneficiary has a history of problematic hypoglycemia consistent with one of the following pathways to coverage:

  1. Beneficiaries with non-insulin treated diabetes and a history of recurrent (more than one) level 2 hypoglycemic events
    1. The treating practitioner must document at least one of the following in the medical record for each event:
      1. The glucose values for the qualifying event(s) (glucose <54 mg/dL (3.0 mmol/L)); or, Classification of the hypoglycemic episode(s) as level 2 event(s); or,
      2. Incorporate a copy of the beneficiary’s BGM testing log into the medical record reflecting the specific qualifying events (glucose <54 mg/dL (3.0 mmol/L)); and,
    2. Documentation of more than one previous medication adjustment and/or modification to the treatment plan (such as raising A1c targets) prior to the most recent level two event
    1. Beneficiaries with non-insulin treated diabetes and a history of at least one level 3 hypoglycemic event
      1. The treating practitioner must document at least one of the following in the medical record:
        1. The glucose value for the qualifying event (glucose <54 mg/dL (3.0 mmol/L)); or,
        2. Classification of the hypoglycemic episode as level 3 event; or,
        3. Incorporate a copy of the beneficiary’s BGM testing log into the medical record reflecting the specific qualifying event (glucose < 54mg/dL (3.0 mmol/L)); and,
      1. An indication in the medical record that the beneficiary required third party assistance for treatment.

Whether an in-person or Medicare-approved telehealth visit, the medical record must support the beneficiary continues to adhere to their diabetes treatment plan and use of the CGM device.

Express Scripts Provider Manual – 2023 Updates

All PBMs update their Provider Manuals at regular intervals and Express Scripts (ESI) is no exception. Express Scripts released an updated version of their Provider Manual in January 2023 and provided a “summation of changes” document for network pharmacies that provides a brief description of the changes and where in the Provider Manual the change occurred. Here are important changes that may impact audits:

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  1. Section 5.2 Compliance Checks (revised)
    1. ESI has modified the items that may be requested during a Compliance Check
    2. ESI performs “compliance checks” which are unannounced onsite audits that involve observations of pharmacy to ensure compliance with the contract as well as laws, rules and other regulations. These visits do not include review of prescriptions but notably do review “other pharmacy records” like written policies and procedures and FWA compliance documentation. We have also seen auditors request to see your refrigerator, will-call bins and inventory stock shelves.
  2. Section 5.4 Overbilled Quantity discrepancy (revised)
    1. ESI has modified the definition of the “Overbilled Quantity” discrepancy.
    2. An example of an overbilled quantity could be submitting an incorrect day supply to circumvent a ‘needs prior authorization’ reject message.
    3. A recent audit example was a prescription for diabetic test strips quantity #200 and sig of test 10 times daily and claim rejects when billed as a 20-day supply so pharmacy changes to a 30-day supply to get a paid claim rather than pursue prior authorization.
  3. Section 5.11 Copay Collection (revised)
    1. ESI has added additional language under the Copayment Collection section to specify that they may request check copies, credit card transaction records and point of sale receipts to confirm copay collection.
  4. Section 5.11 Prior Authorization (revised)
    1. Pharmacies that provide assistance to prescribers in completing prior authorizations must have written authorization on file and this documentation is subject to audit review.
  5. Section 5.11 Valid Claim Submission (new)
    1. ESI has added this new section that spells out pharmacy responsibility to ensure that all claims information submitted is accurate and complete and only submitted in accordance with a valid prescription. Claims submitted without a prescription (e.g. “test claims”) may result in recoupment or network termination.
  6. Section 5.12 Fraud, Waste, and Abuse Investigations of Network Providers (new) and Section 5.13 Dispute Resolution for Fraud, Waste, and Abuse Investigations of Network Providers (new)
    1. ESI has added these new sections to differentiate “investigations” from “audits”
    2. PAAS National® often sees multiple rounds of document requests before investigations are concluded
    3. Investigations often include inventory evaluations and outreach to patients or prescribers to corroborate information gathered directly from pharmacy
    4. Pharmacies may appeal final results within 30 days
    5. State audit laws may be more easily circumvented when reviews are labeled as investigations rather than audits

PAAS Tips:

Black Market HIV Medications Are Not Worth the Savings!

According to a statement released by the U.S Attorney’s Office in the Southern District of New York, five individuals were arrested the morning of March 2, 2023 as a result of defrauding government insurance plans, including Medicaid and manipulating low-income individuals out of their HIV medications from July 2020 through February 2023. This resulted in $15 million worth of illegitimate payments to the pharmacy from government insurance plans. Instead of purchasing the HIV medications through accredited distributors, the pharmacy opted to buy HIV medications from the black market, totaling over $6 million worth of purchases.

In the fraud scheme, an individual sold the black-market HIV medications to a pharmacy store owner with two pharmacy locations in Bronx, New York. He subsequently dispensed the black-market medication to patients with HIV in addition to submitting fraudulent insurance claims for profit. The other three indicted individuals were employed by the pharmacy and assisted the pharmacy owner in paying illegal kickbacks to incentivize patients to use their pharmacy for their HIV medications. To make matters worse, the pharmacy team encouraged patients to sell their HIV medications back to the pharmacy, foregoing the treatment meant to control their HIV infections. The five individuals are looking at time in prison varying from 27 to 47 years if sentenced to the maximum.

Although this is a case that shows blatant intent of actions, the basis still applies:

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  • Properly vet your wholesalers
    • Utilize NABP’s website to check for Drug Distributor Accreditation
    • Review the FDA’s website to see which wholesalers are licensed by your state
    • Be familiar with the Drug Supply Chain Security Act, or the Track and Trace law, and ensure your pharmacy utilizes wholesalers who can provide pedigrees
    • Get additional tips in the following Newsline articles pertaining to vetting wholesalers and distributors
    • Ensure claims are being adjudicated in accordance with a prescription
    • Have your pharmacy team complete their Fraud, Waste, and Abuse Training annually to ensure your team appreciates the repercussions of fraud, waste and/or abuse of medications

PAAS’ Fraud, Waste & Abuse and HIPAA Compliance program keeps members compliant beyond training and exclusion checking. If you aren’t a member of FWA/HIPAA and are interested in saving $129 on your membership, please contact PAAS at (608) 873-1342.

Be On the Lookout for Prescription Reversal Requests from Humana

Humana periodically performs retrospective claim reviews. If upon review Humana determines a claim was billed in error (i.e., after the Humana coverage was terminated), the pharmacy will get a prescription reversal letter. The reversal letter will include a claim detail report listing the claims and dates of service for member(s) who no longer had coverage with Humana at the time the claims were billed. Please see the PAAS Tips below for guidance on what steps to take if your pharmacy receives one of these prescription reversal requests.

PAAS Tips:

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  • Do NOT reverse the claim prior to performing an investigation
  • Make a good faith effort to call the patient and see if they have other insurance
    • If yes, try to rebill the claim with the insurance information provided by the patient
    • Only if the new claim is paid in full should the pharmacy reverse the original Humana claim and sign the form to send back to Humana
    • If the patient does not have other coverage for that date of service, or the pharmacy gets a rejection when trying to bill the new coverage, send a note to Humana per the guidance provided in the letter. You can also include a print screen of the rejection
  • Do not sign the claim detail report as Humana may interpret your signature as an approval to reverse the claim
  • Push back that the claim was adjudicated at the point of sale. If Humana would have had the coverage termination date populated correctly, the claim would’ve rejected at that time
  • Reiterate that you do NOT give Humana authorization to reverse the claim(s) in question
  • Write up a statement that the pharmacy made a good faith effort to contact the patient for additional coverage on that date(s) of service and the pharmacy should not be held liable for Humana’s error