LIVE WEBINAR AUGUST 17th: Understanding Interchangeability with Prescription Biologics

Join President of PAAS National®, Trenton Thiede, PharmD, MBA for a LIVE webinar “Understanding Interchangeability with Prescription Biologics” on August 17, 2022 from 2-2:45pm CT as he discusses:

  • The background and terminology associated with biologics
  • How to identify and recognize unbranded biologics
  • Currently approved interchangeable biologics
  • The FDA Purple Book as a resource

How to approach new biologic prescriptions

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.

SIGN UP TODAY!

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

DMEPOS Targeted Probe and Educate Program – Process Improvement Plan

There has been a sharp increase in the number of Targeted Probe and Educate Program audits on diabetic testing supplies.

DMEPOS Mini-Series #3 – Diabetic Test Strips

If you are a Medicare Part B supplier, then you have likely had an audit on diabetic test strips. Billing Medicare Part B is quite different than other payors, and consequently, can be very challenging for pharmacies. Being able to produce all the required documentation upon an audit, and making sure that the documentation meets Medicare Part B requirements, is a daunting task. Follow the tips below to be prepared in case of a test strip audit.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Standard Written Order (SWO)  

The SWO must include the following six elements:

  • Beneficiary’s name or their Medicare Beneficiary Identifier (MBI)
  • Date of the order
  • General description of the item(s) – HCPCS code, a HCPCS code narrative, or a brand name/model number
  • Quantity to be dispensed
  • Practitioner’s name or NPI
  • Practitioner’s signature
  • While frequency is no longer a required order element, the SWO does require Quantity to be Dispensed for those items where more than one (1) item is dispensed or where dispensing occurs on a periodic basis (e.g., dressings, drugs, supplies, etc.). Note also that while the SWO has a limited number of required order elements, suppliers/providers are permitted to add elements that may provide clarity for issues such as length of need, frequency of use, dosage form/strength, refills frequency, etc.

Medical Records

  • Best practice would be to obtain medical records prior to billing to ensure:
    • A covered diagnosis
    • Testing frequency
    • Continued need and use
    • Signed by the treating practitioner

Billing

  • Bill only the “Medicare/Medicaid” version of strips
  • Verify the NDC being billed is for the correct package size
  • Attach the correct modifier whether patient is on insulin (KX) or not on insulin (KS)
  • Attach the “CR” modifier (catastrophe/disaster related) and “COVID-19” in the claim narrative if any of the following apply:
    • A signature is not able to be obtained on a proof of delivery
    • Clinical indications are not met for respiratory, oxygen, infusion pump and CGM
    • There is not a face-to-face in person encounter
    • Billing more than a 30 days’ supply for immunosuppressives, oral anticancer, IVIG and enteral nutrition

Dispensing/Proof of Delivery

  • Must include the following six elements:
    • Beneficiary name
    • Delivery address
    • Detailed description of the item(s)
    • Quantity delivered
    • Date delivered
    • Signature of beneficiary or representative
  • Date of delivery should match the date of service billed

Delivering/Mailing

  • When delivering or mailing test strips to Medicare beneficiaries, the pharmacy must have a proof of refill request (PORR) from the beneficiary or their representative which includes the beneficiary’s name, representative’s name and relationship to the beneficiary, item description and quantity left on hand
  • This ensures that the patient has exhausted their current supply and that the pharmacy is not auto-filling or auto-dispensing

Advanced Beneficiary Notice (ABN)

  • If you have reason to believe the strips will not be covered by Medicare, consider obtaining a signed ABN prior to dispensing
    • This allows the transfer of financial liability back to the patient in the event the claim is denied
    • Ensure the ABN is completely and appropriately filled out with a very specific reason Medicare may deny the claim
    • The ABN must be completed and signed on or prior to the date of service

Be sure to utilize all the tools and resources available on your local DME MAC website to ensure you are compliant with Medicare’s billing and documentation rules. Below are some past Newsline articles to help you comply as well:

On-Demand Webinar: Caremark’s Bulk Purchasing Requirements and the Importance of Cultural Competency

On June 15, 2022 PAAS National® hosted Caremark’s Bulk Purchasing Requirements and the Importance of Cultural Competency webinar. PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Member Portal.

For easy viewing, we’ve split the webinar into two separate recordings.

The importance of Cultural Competency reviews:

  • Laws pertaining to Cultural Competency and Linguistically Appropriate Services
  • Enhancing patient experiences with Cultural Competency training

Caremark’s Bulk Purchasing Requirements reviews:

  • Caremark’s updates to bulk purchasing requirements
  • Purchasing scenarios that place your pharmacy at risk

New Tools Available! Biologic and Non-Biologic Injectable Medication Reference Charts

Ever wonder if you were billing the correct NDC for a Humira® prescription and had to spend precious time investigating? Or how about questioning if you were billing the correct package size for Gvoke® and had to consult multiple references just to try and figure out the answer? Perhaps you had audit on Ajovy® only to find your pharmacy facing recoupment because the auto-injector was billed but the script was written for the pre-filled syringe.

PAAS National® now has two new reference charts available to help you and your staff with billing these unique injectable products correctly. Check out the Biologic Injectable Medication Chart and Non-Biological Injectable Medication Chart under the Tools & Aids section of the PAAS Member Portal.

PAAS Tips:

  • Utilize the Biologic Injectable Medication Chart to:
    • Determine if there is an interchangeable biologic available in the marketplace
    • Cross reference the correct NDC for medications such as Humira® and Enbrel®
    • Review the available dosage forms for medications such as Simponi® and Emgality®
    • Verify the correct NCPDP billing unit for medications such as Cimzia® and Aimovig®
  • Utilize the Non-Biological Injectable Medication Chart to:
    • Review the available dosage forms for medications such as Abilify Maintena® and Gvoke®
    • Verify the correct NCPDP billing unit for medications such as Lovenox® and Xyosted®
    • Find USP guidance for the expiration date of multi-dose vials (not otherwise indicated by the manufacturer)
  • These injectable medications carry a high audit risk; billing the correct formulation, quantity, NDC and days’ supply is not only essential to receiving the appropriate payment at time of adjudication but also necessary to successfully pass an audit
  • Check out the Tools & Aids tab on the PAAS Member Portal for additional reference charts which have been skillfully and deliberately crafted to save pharmacy staff time and money; print these and post them near the pharmacy claims processing station for easy reference

A Need for a Compliance Program – Attest with Confidence

Since 2009, PAAS National® Fraud, Waste & Abuse and HIPAA Compliance program was designed to meet the CMS requirements, with the full support of our expert staff – pharmacists and technicians just like you, with years of experience helping community pharmacies with FWA and HIPAA compliance. Don’t be fooled by offers for training and exclusion checks – work with the best compliance program available to community pharmacies!

Consider the following:

Humana’s 2022 Notice of Program Requirements

Humana’s Compliance Policy for Contracted Healthcare Providers explicitly states pharmacies must have a compliance program that meets the seven elements outlined by CMS, including written policies, procedures and standards of conduct. Per the 2022 Pharmacy Compliance Education and Training Requirements FAQs: “Humana reserves the right to request documentation (e.g., policies and tracking records) confirming that your organization has an effective compliance program that meets the requirements outlined in the Compliance Policy and Standards of Conduct.”

PerformRx Pharmacy Compliance Attestation 2022/2023

PerformRx requires attestations to the following:

The pharmacy has implemented and maintains a compliance program that is consistent, at minimum, with applicable federal and state requirements, including, but not limited to the standards set forth in 42 CFR §423.504(b)(4)(vi) and other Centers for Medicare & Medicaid Services (CMS) guidance set forth in the Medicare Part D Prescription Drug Benefit Manual.

Be proactive. Be prepared. Be protected. Ensure you have all your compliance bases met so that when you attest to having one, you can provide proof if requested for credentialing or audit.

Don’t have an FWA/HIPAA Compliance Program? Contact PAAS and receive a $126 discount when you combine services with your audit assistance. Get started today! info@paasnational.com or (608) 873-1342.

Is Your Pharmacy Ready for an Unannounced Audit?

Pharmacies are often startled with the limited amount of time a PBM offers prior to an onsite audit. However, PBM auditors, DEA agents, FDA inspectors and state Board of Pharmacy inspectors can also make unannounced visits.

Ensuring your staff members are prepared in case of an unannounced visit is essential. Since these visits occur without warning, the Pharmacist-in-Charge (PIC) and/or owner may not be working or available to assist. Keeping information in a central location and advising staff on how to handle these intimidating visits will make the process go much smoother.

PAAS National® has created a document to help pharmacies prepare for PBM visits. Located on our website, under the Tools & Aids Section, you can find our Onsite Credentialing Guidelines. This tool provides a list of frequently asked questions from auditors. The guide also includes references to the Policy and Procedure Manual for PAAS National® Fraud, Waste & Abuse and HIPAA Compliance members.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

PAAS Tips:

  • Anyone requesting access to PHI (or your professional service area) should be identified with a company issued picture ID and other validating information
    • Follow your pharmacy’s HIPAA policy for visitors. PAAS FWA/HIPAA members can document information on their Visitor’s Log located in their Policy and Procedure Manual
  • Check PAAS’ newest guide How to Be Prepared for An Onsite Audit located in our Tools & Aids Section
  • Make sure all staff are:
    • Up to date on FWA and HIPAA compliance training
    • OIG and GSA exclusion checked; required monthly, PAAS performs these checks daily for our FWA/HIPAA members and records are accessible on the PAAS Member Portal
  • Review and update your FWA/HIPAA Compliance Manual and the Onsite Credentialing Guidelines with your Compliance Officer and/or PIC
  • Keep copies of all documents requested by auditor or inspector
  • Keep copies of any documents you are requested to sign
  • Contact PAAS once your PBM visit is over as we can track this information to better serve all members based on your experience

Don’t have an FWA/HIPAA Compliance Program? Contact PAAS and receive a $126 discount when you combine services with your audit assistance. Get started today! info@paasnational.com or (608) 873-1342.

Beware: DEA and Wholesalers are Cracking Down on Controlled Substance Dispensing

Take note – the DEA is coming after pharmacies dispensing illegitimate controlled substance prescriptions. Pharmacists should all be aware of their corresponding responsibility and the need for a legitimate medical purpose when dispensing controlled substance prescriptions. A review of recent Department of Justice settlements provides guidance on some prescriptions that require additional scrutiny.

Consider the following dispensing activities to be of high risk:

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

  • Dangerous drug cocktails (e.g., opioids with benzodiazepines, muscle relaxants, and/or stimulants)
    • Often known as the ‘Holy Trinity’ on the street: opioid, benzodiazepines, and muscle relaxant
  • High opioid doses that far exceed FDA dosage guidance
  • Controlled substance prescriptions for patients traveling long distances
  • A patient who uses multiple prescribers and multiple pharmacies to fill their controlled substances
  • Suspicious prescriptions from providers who are now sanctioned by state and federal authorities
    • When a prescriber is sanctioned, the DEA will look downstream at pharmacies that ultimately dispensed medications from the prescriber
  • Providing early refills of opioid prescriptions
  • Schedule II prescriptions for opioid dependence, which is not a legitimate medical purpose

Dispensing combinations of controlled substances that have no legitimate medical purpose, are highly addictive and specifically used to create or enhance abusive and euphoric effects, is a violation of 21 CFR 1306.04(a). Pharmacists have a responsibility to ensure the appropriateness of the prescriptions they are dispensing. While turning away business is never easy, being fined and sanctioned by the DEA is a much more painful process to endure.

Consider a few DEA settlements over the last couple years:

  1. Pharmacy Agrees to Pay $1.5 million to resolve allegations it filled illegitimate controlled substance prescriptions (May 2022)
  2. Pharmacist to pay $275,000 to settle claims related to the alleged unlawful dispensing of controlled substances (including the ‘holy trinity’) (November 2021)
  3. Pharmacy, pharmacist to pay $2.1 million for dispensing illegitimate prescriptions (March 2020) Note: This settlement was the fifth prosecution of pharmacies/pharmacists affiliated with a convicted pill-mill doctor

Drug wholesalers are also pulled into the fray with their responsibility to identify and report “suspicious orders” of controlled substances. McKesson, Cardinal Health, and AmerisourceBergen have all had settlements and/or civil penalties (as high as $150 million) related to Controlled Substance Act violations. In 2019, there were felony criminal charges filed against a distributor and its executives for illegal distribution of controlled substances. Their failure to effectively oversee suspicious orders caused them to go out of business.

Consequently, wholesalers are increasing their constraints on controlled substance purchasing. There are more rigorous applications, wholesaler audits, and purchasing thresholds which cannot be exceeded. PAAS National® has also become aware of wholesalers (nearly immediately) terminating a pharmacy’s ability to purchase controlled substances. In its notice to the pharmacy, the wholesaler flagged the following practices:

  • Dispensing antagonistic combinations concurrently (benzodiazepines or opioids with amphetamines)
  • Dispensing therapeutic duplications (two benzodiazepines or two IR/ER opioids)
  • Dispensing opioids and benzodiazepines concurrently
  • Dispensing controlled substance prescriptions for prescribers with current, or historical, discipline – particularly as it relates to prescribing concerns
  • Lacking policies and procedures to ensure against the diversion of controlled substances

PAAS Tips:

  • Review the DEA Pharmacist’s Manual (updated in 2020)
  • Utilize your state’s controlled substance Prescription Drug Monitoring Program to identify early refills, polypharmacy, and multiple prescribers
  • Educate all staff on high risk dispensings

When Should I Obtain a Diagnosis Code for Ozempic?

Since Ozempic® was FDA approved December 5, 2017, PAAS National® has fielded many questions regarding dispensing this expensive injectable diabetic medication. The questions relate to dosing, calculations, billing, and off-label use. PAAS cannot overemphasize the importance of calculating the correct days’ supply. Use the chart below and prior PAAS articles to help pharmacy staff calculate the correct days’ supply.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

NDC Label Color Dose Administered Initial or Maintenance Dose Number of Pens Per Box Milligrams Per Pen Billing Quantity Per Box
00169-4132-12 Red 0.25 mg or

0.5 mg only

Initial Dose (0.25 mg) or

Maintenance Dose (0.5 mg)

1 pen 2 mg 1.5 mL
00169-4130-13 Blue 1 mg only Maintenance Dose 1 pen 4 mg 3 mL
00169-4772-12 Yellow 2 mg only Maintenance Dose 1 pen 8 mg 3 mL

Off-label use is a concern because of Wegovy™, which has the same analog name (semaglutide) as Ozempic®, but is FDA approved for weight loss. To reduce audit risk, pharmacies should be vigilant in attempting to identify when a prescriber is working around a plan exclusion or prior authorization by prescribing Ozempic® instead of Wegovy™. With the FDA’s approval of 2 mg weekly dosing for Ozempic in March 2022, this became more challenging as higher dosing is not necessarily indicative of off-label use. Keep in mind, federal programs like Medicare Part D and Medicaid do not pay for off-label use and claims billed for non-diabetic patients could be recouped. Consider obtaining a diagnosis code if any of the following apply when starting patients on Ozempic:

  • The prescription was originally written for WegovyTM
  • This is the first antidiabetic agent being prescribed for the patient
  • The prescription is written for the analog name
  • The prescription has an indication for weight loss

Pharmacies dispensing Ozempic prescriptions for weight loss may incur significant audit recoupments. Consider collaborating with prescribers to educate them on the risks to help ensure appropriate billing practices.

PAAS Tips:

  • Medicare gives preference to a “pay and chase” model when it comes to claims – they want beneficiaries to receive needed medications and will pay the claim at point-of-sale assuming the medication is being used in an FDA approved manner
  • According to the package insert for Ozempic®, 0.25 mg per week is considered the first step in the initiation of Ozempic® and would be considered a subtherapeutic dose as it is insufficient for glycemic control
  • The NCPDP billing unit for Ozempic® is “mL” however; the patient instructions are to inject “mg”
  • See November 2021 PAAS Newsline article, Beware: Same Ingredients, Different FDA Indications
  • See February 2022 PAAS Newsline article, Oh, Oh, Oh… Ozempic®
  • See March 2022 PAAS Newsline article Off-Label Use Not Covered Under Medicare Part D

Insulin Glargine (Winthrop) – Unbranded Biologic of Lantus®

Insulin glargine labeled by Winthrop U.S. came to market in May 2022, and with it a lot of additional confusion regarding pharmacy level substitution.

Keen eyed observers will notice that Winthrop is “a Sanofi company”, and that both Lantus® and insulin glargine (Winthrop) have the same Biologics Licensing Application (BLA) number BLA021081 – which makes it an “unbranded biologic” of Lantus®.

Please see a few important notes about unbranded biologics from FDA Purple Book FAQ #9:

  1. Unbranded biologics are not separately listed in FDA Purple Book
  2. Unbranded biologics are not the same as an interchangeable biosimilar
  3. Unbranded biologics are considered by FDA to be equivalent to its brand name biological product because it is the same product as the brand name biological product under the same BLA

Remember that pharmacy level substitution of a reference product is only allowed if biologic drugs are either (i) identified as interchangeable OR (ii) an unbranded biologic with the same BLA number. For biologic drugs that don’t fall into these two categories, you must obtain prescriber approval prior to substituting.

Here is a summary table of how to understand insulin glargine products:

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Prescription written as: Okay to substitute WITHOUT prescriber approval (if allowed by state law)
Lantus®

BLA 021081

Reference Product

Insulin glargine (Winthrop)

BLA 021081

Unbranded biologic

Semglee®

BLA 761201

Reference Product

Insulin glargine-yfgn (Mylan)

BLA 761201

Unbranded biologic

Basaglar®

BLA 205692

Reference Product

Lantus® Yes Yes Yes Yes No
Semglee® Yes Yes Yes Yes No
Basaglar® No No No No Yes
Insulin glargine* Yes, however consider clinical context – has patient taken one product previously?

*Treat this like a situation where prescription is written as “albuterol sulfate HFA inhaler”

PAAS Tips:

  • Unbranded biologics should be treated in the same way as an authorized generic.
  • State pharmacy laws may limit biosimilar interchangeability, but this does not apply to unbranded biologics. For information about your state laws:
  • See updated Insulin Medication Chart under the Tools & Aids section of the PAAS Member Portal