After reading this article you should understand what a multi-language insert is, why it must be provided, and when you are required to hand it out.
What is a multi-language insert (MLI)?
You have likely seen a MLI if you have received any written communication from your health plan. The document will offer free interpreter services along with a phone number to call to ask questions about your health or drug plan.
Specific details about what a MLI must contain can be found in 42 CFR § 423.2267(e)(33), “This is a standardized communications material which states, ‘We have free interpreter services to answer any questions you may have about our health or drug plan. To get an interpreter, just call us at [1-xxx-xxx-xxxx]. Someone who speaks [language] can help you. This is a free service.’ in the following languages: Spanish, Chinese, Tagalog, French, Vietnamese, German, Korean, Russian, Arabic, Italian, Portuguese, French Creole, Polish, Hindi, and Japanese.”
Why must a multi-language insert be provided?
Notification of this requirement was published on May 9, 2022 in the Federal Register, 87 FR 27704. According to the notice, 12.2 percent of persons aged 65 and older speak a language other than English in their home. The multi-language insert is meant to inform individuals that free interpreter services are available to them. This helps ensure that all patients are provided equal access to care across all patient populations. For more information about providing equal access, contact PAAS National® at (608) 873-1342 to learn more about our Cultural Competency and Linguistically Appropriate Services using the PAAS CARE Model.
When must a multi-language insert be handed out?
According to 87 FR 27704, the insert must be handed out “whenever a Medicare beneficiary is provided a CMS required material.” Lists of CMS-required materials can be found under 42 CFR§ 422.2267(e) and 42 CFR § 423.2267(e). Pharmacies would be directly impacted by 42 CFR § 423.2267(e)(21) – “Medicare Prescription Drug Coverage and Your Rights. This is a standardized communications material used to convey a beneficiary’s appeal rights when a drug cannot be filled at point-of-sale.” Since pharmacies are required to hand out the Medicare Prescription Drug Coverage and Your Rights form (CMS 10147), a CMS-required document, the MLI must be provided concurrently.
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- Auditors often confirm pharmacies are distributing the current version of CMS 10147 to Medicare beneficiaries, as required, and now they may look for the MLI as well (Elixir has explicitly stated that they will review this during onsite audits)
- There is no requirement for pharmacies to document the distribution of the MLI
- The phone number on each MLI is PBM-specific; if a MLI is not automatically generated by your software system with a populated phone number, we suggest utilizing the numbers below (TTY numbers are for people who have hearing loss or speech impairment which makes using a regular telephone difficult; conversations are typed instead of vocalized):
- For additional details regarding MLI, refer to 42 CFR§ 422.2267(e) and 42 CFR § 423.2267(e)
Are Your Delivery/Signature Logs PBM Compliant for 2023?
A common component of a pharmacy audit request is the delivery/signature log. Delivery/signature logs are used to prove the patient received their medication and that they received it within the PBM return to stock timeframe. PAAS Audit Assistance members can refer to the PBM Return to Stock Chart on the PAAS National® Member Portal for a list of the major PBMs and their return to stock time frame allowances.
PAAS often sees delivery/signature logs flagged for having a pre-printed delivery date. Several PBMs do not accept these logs because they may not represent the actual delivery date. Here is an example:
Recent Elixir results state, per the Elixir pharmacy manual, “Receipt submitted states “Delivery.” Unless the prescription delivery is through a common courier, an electronic or manual signature should be recorded at time of delivery by the member or designated member representative. For deliveries, the date delivered cannot be pre-printed by the pharmacy.”
Some software systems allow a pharmacy to “scan out” a prescription and flag it for delivery. The driver can take this date/time stamped point of sale receipt (that notates delivery) to the patient’s address and have them sign. PAAS also sees many LTC facility delivery manifests containing a pre-printed date on the document. An auditor is not going to accept/assume the delivery took place the same day as the pre-printed date and will likely flag these logs as invalid. The pharmacy needs to provide documentation of when the delivery took place by having the patient, or representative, date their signature upon delivery. Consider adding a blank line for a handwritten date next to the signature line that can be completed upon delivery.
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Process for Dealing with a Patient HIPAA Complaint
Anyone can file a complaint if they feel their rights under the HIPAA Privacy, Security, or Breach Rules have been violated. They can file a complaint with the covered entity or business associate involved, or with the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (the OCR). The HHS.gov website has a full page dedicated to filing a complaint and is one of the first listings to appear if someone performs an internet search for “filing a HIPAA complaint”.
Appropriately handling the patient’s complaint by taking it seriously, investigating, and responding may help decrease the risk of the OCR launching an investigation into your pharmacy. Additionally, if an investigation does occur, following the steps listed below can help ensure that your pharmacy would have all the required information documented to prove you handled the situation pursuant to the HIPAA Rules.
Steps to follow if a patient believes their HIPAA rights have been violated:
If HIPAA Rule violations are found during an OCR investigation, the pharmacy can be forced to pay civil money penalties and can even be held accountable for an employee’s failure to adhere to company HIPAA policies and procedures. Additionally, individuals accessing or utilizing protected health information inappropriately can be charged civil money penalties or even face criminal charges (and jail time!) for violating the HIPAA Rules.
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Express Scripts Validating 340B Claim Eligibility
PAAS continues to see members receiving emails from Express Scripts (ESI) requesting pharmacies to “Please Review Your 340B Eligible Claims”. ESI’s goal is to verify manufacturer rebate eligibility and states “your claims reimbursement, network participation, and network status are not affected by a claim’s status as 340B-eligible or whether you respond”.
While seemingly haphazard in claim selection and frequency, Express Scripts is attempting to identify a subset of claim(s) that were initially processed as not 340B-eligible, but in actuality may have been dispensed/reimbursed as 340B. From communication with members, PAAS can see the algorithm ESI is using is far from perfect. Conjecture leads us to believe they are using the HRSA OPAIS website to look at providers and pharmacies, then targeting high dollar brand medications.
If the pharmacy agrees that the claims were 340B claims, no action is required and Express Scripts will reprocess the claim(s). If the pharmacy believes the claims were correctly adjudicated as non-340B eligible, the pharmacy should respond within 10 business days by emailing 340bclaims@express-scripts.com to refute Express Script’s conclusion.
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Update to PAAS’ Onsite Credentialing Guidelines
PAAS National® has created an Onsite Credentialing Guidelines, an extensive checklist to assist PAAS members with scheduled and/or unexpected visits from PBM auditors. Unannounced visits can catch pharmacy staff off guard when the Pharmacist-in-Charge (PIC) is not present. Be sure you are reviewing and advising your staff on the information included on this checklist so they are prepared.
There was an 11% increase in reported onsite audits over the past two years. PAAS takes pride in staying up to date on ever changing trends in pharmacy. Keeping our members informed on PBM inquiries during the credentialing process, or an onsite visit, is one of our priorities. We recently added the following updates to our Onsite Credentialing Guidelines:
Interested in having a customized FWA/HIPAA Compliance program? Contact PAAS to get started today! info@paasnational.com or 608-873-1342.
Audit Risk: Pre-Printed Prescription Forms
At a time when the workday seems to be growing ever more hectic, prescribers and pharmacies may find pre-printed prescription forms convenient; especially for medications which are frequently utilized by a prescriber for treatment. Many PBMs prohibit pre-printed prescription form use for various reasons. Forms created by the pharmacy for the prescriber are concerning because it could appear the pharmacy is soliciting prescriptions or attempting to steer the patient to their pharmacy, particularly if the pharmacy’s name and branding (logo) are pre-printed on the form. Concerns that the forms are not specific enough for each individual patient need with the same quantity, refill number, and directions can also come up.
PAAS National® has seen pre-printed prescription forms considered invalid when they have cascading or overly broad substitutions. For example, if a topical medication is not covered, the form states the prescriber allows the pharmacy to substitute the next topical medication on the form and so on until one is covered. These medications tend to be more expensive than an alternative the plan may prefer and are a red flag for audit when the pharmacy is seen transmitting claims, reversing them, and billing a different product in rapid succession. Many PBM provider manuals have now added language requiring pharmacies to have a verbal conversation with the prescriber before making any substitutions, which would need to be proven with a clinical note documented on the prescription.
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Why Does Billing the Correct Origin Code Matter?
Pharmacies are required to enter an origin code on claims to indicate where the prescription came from or “originated.” By definition, an origin code cannot change and should remain billed as how the pharmacy originally received the prescription from the prescriber, even when clarifications of that prescription are done by telephone.
Why does billing the correct origin code matter?
NCPDP defines origin code values as follows:
Here are questions PAAS National® has frequently answered:
Question 1: If a pharmacy calls a prescriber to clarify a written prescription, or a change is needed, does the origin code become a “2” for Telephone?
Answer: No, the NCPDP Telecommunication FAQ section 3.1.5.3 states, “Because the prescription was received via written form the Prescription Origin Code is 1 and will remain a 1 throughout the life of the prescription number.” The same would be true if received by any other origin.
Question 2: If a prescriber sends a prescription electronically, but the pharmacy is not electronically-prescribing enabled or if there is a transmission error, and the intermediary drops the prescription to a fax, what origin code is used?
Answer: Per NCPDP, “Because the prescription was received at the pharmacy via fax the Prescription Origin Code is 4 and will remain a 4 throughout the life of the prescription number.”
Question 3: What origin code is used for a standard written authorization or protocol for services and products like, vaccines or Narcan®?
Answer: The NCPDP definition for protocols is Prescription Origin Code of “5” since the prescription is created by the pharmacy in these cases.
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Medicare Caps Copay for Insulin at $35 per Month
As most of you (and your Medicare patients) have undoubtedly noticed, Medicare has applied a $35 per month cap on copays for insulin prescriptions ($105 for a 3-month supply) for years 2023-2025. For 2026 and beyond, copays will be capped at the lesser of $35 or 25% of the negotiated price.
Section 11406 of the Inflation Reduction Act of 2022 implemented this cap for Medicare Part D and Medicare Advantage patients effective January 1, 2023, while Section 11407 requires implementation for Medicare B covered insulin as of July 1, 2023.
Plan Sponsors have a 90-day grace period to implement these copay caps and any excess copays calculated at adjudication must be refunded by the plan.
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- The definition of “one month” varies by plans
- Pharmacies should collect the full copay amount as per online adjudication and advise patients that the plan will refund patients for any amounts in excess of $35 per month
- Pharmacies should be extra diligent when calculating days’ supply and make sure you have mathematical instructions that support the days’ supply adjudicated
- See the Insulin Medication chart and Can You Bill It As 30 Days? tool on the PAAS Member Portal for additional guidance
- The CMS has created the following resources for Medicare patients
- 7 Things to Know about Medicare Insulin Costs
- Frequently Asked Questions About Medicare Insulin Cost-Sharing Changes in the Prescription Drug Law
Multi-Language Insert Must Be Provided to Medicare Beneficiaries as of January 1, 2023
After reading this article you should understand what a multi-language insert is, why it must be provided, and when you are required to hand it out.
What is a multi-language insert (MLI)?
You have likely seen a MLI if you have received any written communication from your health plan. The document will offer free interpreter services along with a phone number to call to ask questions about your health or drug plan.
Specific details about what a MLI must contain can be found in 42 CFR § 423.2267(e)(33), “This is a standardized communications material which states, ‘We have free interpreter services to answer any questions you may have about our health or drug plan. To get an interpreter, just call us at [1-xxx-xxx-xxxx]. Someone who speaks [language] can help you. This is a free service.’ in the following languages: Spanish, Chinese, Tagalog, French, Vietnamese, German, Korean, Russian, Arabic, Italian, Portuguese, French Creole, Polish, Hindi, and Japanese.”
Why must a multi-language insert be provided?
Notification of this requirement was published on May 9, 2022 in the Federal Register, 87 FR 27704. According to the notice, 12.2 percent of persons aged 65 and older speak a language other than English in their home. The multi-language insert is meant to inform individuals that free interpreter services are available to them. This helps ensure that all patients are provided equal access to care across all patient populations. For more information about providing equal access, contact PAAS National® at (608) 873-1342 to learn more about our Cultural Competency and Linguistically Appropriate Services using the PAAS CARE Model.
When must a multi-language insert be handed out?
According to 87 FR 27704, the insert must be handed out “whenever a Medicare beneficiary is provided a CMS required material.” Lists of CMS-required materials can be found under 42 CFR§ 422.2267(e) and 42 CFR § 423.2267(e). Pharmacies would be directly impacted by 42 CFR § 423.2267(e)(21) – “Medicare Prescription Drug Coverage and Your Rights. This is a standardized communications material used to convey a beneficiary’s appeal rights when a drug cannot be filled at point-of-sale.” Since pharmacies are required to hand out the Medicare Prescription Drug Coverage and Your Rights form (CMS 10147), a CMS-required document, the MLI must be provided concurrently.
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- Auditors often confirm pharmacies are distributing the current version of CMS 10147 to Medicare beneficiaries, as required, and now they may look for the MLI as well (Elixir has explicitly stated that they will review this during onsite audits)
- There is no requirement for pharmacies to document the distribution of the MLI
- The phone number on each MLI is PBM-specific; if a MLI is not automatically generated by your software system with a populated phone number, we suggest utilizing the numbers below (TTY numbers are for people who have hearing loss or speech impairment which makes using a regular telephone difficult; conversations are typed instead of vocalized):
- Caremark – General Customer Care from their Contact Us webpage, 1-800-552-8159 (TTY: 711)
- Elixir – From their MLI memo issued November 16, 2022 which included a full MLI insert, or from their Language Support webpage, 1-800-361-4542
- Express Scripts® – Medicare Members, 1-866-529-4917 (TTY users call 800-899-2114)
- Humana – 1-877-320-1235 (TTYL 711)
- Independence Blue Cross – Based on their Non-Discrimination Notice and Multi-Language Insert webpage, 1-800-275-2583 (TTY: 711)
- OptumRx® – From their Language Assistance Services webpage, “please call the toll-free number on your member ID card,” or call the OptumRx® customer service 1-800-356-3477
- For additional details regarding MLI, refer to 42 CFR§ 422.2267(e) and 42 CFR § 423.2267(e)
Ozempic and Mounjaro Prescriptions – Between a Rock and a Hard Place
Many pharmacies continue to receive new prescriptions from patients eager to start on therapy for Ozempic® and MounjaroTM. Oftentimes, these patients are hopeful and excited to start on this long-term therapy to help manage their underlying indication and may quickly become upset and confrontational with your staff if they are told “we don’t have this in stock”, “this medication requires a prior authorization” or “I don’t think this is covered by your insurance unless you have type 2 diabetes”.
Glucagon-like peptide-1 (GLP-1) receptor agonists like Ozempic® and MounjaroTM have recently gone viral on social media and are the hottest craze in Hollywood for a very desirable side effect – weight loss. As a result, many prescribers have prescribed them “off-label” for indications such as weight loss, pre-diabetes and metabolic syndrome, despite having been only FDA approved for type 2 diabetes. While off-label prescribing is common and perfectly acceptable in medical practice, pharmacies become stuck not knowing whether a patient’s insurance company pays for these medications in the absence of a type 2 diabetes diagnosis. Pharmacies report that many patients are presenting these prescriptions after having previously received prescriptions for Saxenda® or Wegovy® (that were not covered by insurance) or having been turned away by other pharmacies.
Some Payors have implemented Utilization Management tools such as Prior Authorization or Diagnosis Restriction to confirm why the patient is using the medication before paying (or denying) the claims – in these situations the pharmacy should be much less concerned.
When claims for GLP-1 medications pay at point-of-sale without any utilization management, PBMs may still expect pharmacies to “police” these medications and be able to accurately tell patients that the drug is covered or not covered (PAAS Audit Assistance members can see Mounjaro Off-Label Use for Weight Loss Spells T-R-O-U-B-L-E from November 2022). Inevitably, this puts pharmacy staff between a rock and a hard place when patients are using medications off-label.
Understandably, pharmacies have a difficult time determining if an individual patient’s insurance company will approve coverage for a GLP-1 medication for conditions other than type 2 diabetes. Researching plan benefits is often an exercise in futility, and PBM help desks are unlikely to have the clinical expertise.
The risk of a future PBM audit looms and it would be easy for a crooked PBM to pay the claim now, audit the pharmacy later and argue that “you (the pharmacy) should have known that we (the PBM) only cover this drug for type 2 diabetes”. Is this fair? Absolutely not, but when was the last time PBM audits were fair?
Consider these audit discrepancies from MedImpact:
While these claims were not related to Ozempic® or MounjaroTM, they easily could have been. With vertical integration amongst PBMs and Health Insurers, it’s easy to see how data could flow amongst them to identify off-label drug utilization; and with an annual treatment cost of nearly $12K per year, payors are going to look to reduce its utilization.
Dispensing these medications, when you can even get them in stock, is very complicated based on the large sticker price, the risk of audit and the immediate backlash you may face from patients and local prescribers if you say “no” or even “let’s try to figure this out”.
PAAS wants to help you and your patients get access to prescribed therapies and we recognize that refusing to fill prescriptions is not good for business or customer satisfaction. While there is not a one-size-fits-all approach, here are some best practice suggestions to keep your pharmacy safe from audit and create the fewest waves with parties involved.
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PBM Prescription Validation Requests Rose Nearly 20% in 2022!
Prescription Validation Requests (also known as claim reviews) are becoming a more frequent occurrence with many PBMs. In 2022, PAAS saw an 18% increase year over year. Some of the reasons these claims get flagged include:
While these requests are a nuisance, they can work to the pharmacy’s benefit. With the PBM looking at the claim prospectively (before payment is received), pharmacies can avoid incorrectly refilling medication if an error is detected. Conversely, if a pharmacy is not prompted to correct an error (when one exists) and the claim is refilled over the course of a year, the financial recoupments can be much greater upon audit. The frustration comes in when these claim reviews are repetitious, and false positives (i.e., no billing errors) – creating work for the pharmacy without the need for claim correction.
Below is a chart of the various PBMs conducting these prospective reviews and the details/nuances associated with each. OptumRx/EXL® makes up the majority of these pre-claim reviews that members report to PAAS. OptumRx defines the Prescription Validation Request (PVR) in their pharmacy manual as follows:
Administrator conducts limited scope prescription validation reviews for quality assurance purposes (“PVRs”), which are distinct from and are not considered audits. PVRs are utilized to verify the accuracy and validity of prescription claim submissions. Claims are monitored daily for appropriateness and potential billing errors and selected for review prior to payment. Network Pharmacy Providers are typically contacted via fax or email and asked to provide photocopies of specific documents and records related to its claims submitted to Administrator.Join today!
PBM
Title of Request
Days to Respond
Targeted Claims
Caremark®
Concurrent Claim Review
3
Compounds, non-FDA approved products, injections
Express Scripts®
Claims for Investigative Review
5
CII’s
Humana®
Pharmacy Claim Validation Request
3 business
Potentially misbilled claims
MagellanRx/Conduent
Claim Check verification review
7
High dollar (Emgality ®, insulin)
MedImpact
Pre-pay Claim Review
3 business
Potential billing errors
OptumRx/EXL®
Validation Request
14 business
High dollar (Humira®, Enbrel®, insulin, inhalers)
Prime Therapeutics
Initial Documentation Request
2
High-dose insulin
- Send the validation review request to PAAS National® right away as these can often have short deadlines
- Include a copy of the prescription and your backtag for the date of service in question so that we can verify claim billing
- Most requests do NOT require a signature log, but PAAS will confirm if required after reviewing your audit notice.
- Often, these claims are very recent and sometimes have not even left the pharmacy
- A response is required even if claim has been reversed
- If a claim is recent (within) 30 days, and there is a billing error, the pharmacy can often correct the claim (if applicable)
- If the PBM finds the claim to be accurately billed, the pharmacy will not receive any “results”
- Even though these requests are not typically labeled as an “audit”, PAAS has seen PBMs deny payment on the claim and/or issue “results”
- If the pharmacy received what looks like “results,” send to PAAS for guidance. The “results” may list an estimated overpayment amount which is often a consequence of external auditing entities not having real time claims access
(Unusual quantity and days’ supply combination)
(Unusual quantity and days’ supply, incorrect DAW code)
While PBMs have fancy names for these requests, make no mistake: if it looks like an audit, you must submit documentation like an audit, and you get results (and recoupments) like an audit, it is an audit!
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