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.

PAAS Tips:

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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)

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.

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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.

  • There is not a known list of “acceptable” diagnosis codes for PBMs or Plans
  • If the PBM has not designated the particular NDC as diagnosis restricted, then any diagnosis codes (ICD-10) submitted by the pharmacy are likely not reviewed, and pharmacies should not assume the PBM used the code as part of adjudication logic to determine payment of claim

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.

  • For patients with type 2 diabetes (ICD-10 diagnosis code “E11”), pharmacies can bill insurance and follow corresponding claim adjudication logic without additional concerns.
  • However, for any other diagnosis the pharmacy should consider stating: “I don’t know if your insurance covers for indication X”.

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:

  • The diagnosis code of the corresponding medical claim does not support the billing of this medication
  • There is no corresponding medical claim to support the billing of this medication

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.

PAAS Tips:

  1. All prescriptions for GLP-1s should be verified for indication of use
    1. Check patient profile for previous use of type 2 diabetes medications as a proxy
    2. Check the prescription to see if it came with a diagnosis code
    3. Contact the prescriber to confirm indication and document a clinical note
  2. If patient has E11 type 2 diabetes mellitus, then you should have limited concerns
    1. Your pharmacy will need to determine which other diagnoses you are comfortable billing to insurance without questioning further
  3. If claim requires prior authorization or is diagnosis code restriction (regardless of patient diagnosis), follow standard processing procedures
  4. All other claims pose audit risk and the pharmacy should consider giving the patient options to proceed
    1. Explain to the patient that insurance may not cover without type 2 diabetes diagnosis
    2. If indication is for weight loss, pursue prescription for Saxenda® or Wegovy® first, as these two medications are FDA approved for weight loss
      1. Medicare Part D currently excludes coverage of weight loss agents as per CMS Prescription Drug Benefit Manual Chapter 6, section 20.1
      2. The “Treat and Reduce Obesity Act of 2021” (HR 1577) was introduced in 2021 to allow coverage of prescription drugs for treatment of obesity or weight loss, however this bill is not a law
    3. Explain that the pharmacy wants to help them get their medication, but due to the high cost (>$1,000 per month) it is important to confirm coverage, which can take time
      1. If the patient is willing to wait a few days to start therapy, pursue 4b above (if this hasn’t been explored) and encourage the patient to contact their insurance to confirm coverage for their condition. Note that the PBM help desk is unlikely to have clinical knowledge and patient (or pharmacy) would need to speak with clinical staff such as prior authorization department
  5. If you bill insurance and claims are subsequently audited, PBMs may try to recoup payment of claims if patients do not have type 2 diabetes
    1. Should this occur, PAAS is here to support you throughout the audit process with strategies and resources to fight the recoupments

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:

  • High dollar claims
  • High quantity to days’ supply ratios
  • NDC package size mismatched to quantity billed

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.

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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

(Unusual quantity and days’ supply combination)
MagellanRx/Conduent Claim Check verification review 7 High dollar (Emgality ®, insulin)
MedImpact Pre-pay Claim Review 3 business Potential billing errors

(Unusual quantity and days’ supply, incorrect DAW code)
OptumRx/EXL® Validation Request 14 business High dollar (Humira®, Enbrel®, insulin, inhalers)
Prime Therapeutics Initial Documentation Request 2 High-dose insulin

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!

PAAS Tips:

  • 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

XDEA Numbers Have Been NiXed…but Not the Training

When you are preparing for an audit, a PAAS National® analyst has likely told you to ensure a prescriber’s Drug Addiction Treatment Act (DATA) 2000 Waiver ID, or XDEA number, is included on prescriptions for medications used to treat opioid use disorder along with their regular DEA number. Effective December 29, 2022, the date the Consolidated Appropriations Act of 2023 (“The Act”) was signed, the need for prescribers to have XDEA numbers to prescribe such medications has been eliminated.

Subsequently, on January 12, 2023, the DEA released an informational document. In it, they state their support regarding the policy reform, stating, “At DEA, our goal is simple: we want medication for opioid use disorder to be readily and safely available to anyone in the country who needs it [and] the elimination of the X-Waiver will increase access to buprenorphine for those in need.” The document goes on to state “going forward, all prescriptions for buprenorphine only require a standard DEA registration number” but cautions that state laws and regulations still apply.

The Substance Abuse and Mental Health Services Administration (SAMHSA) echoes the DEA’s sentiment, stating “all practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe buprenorphine for Opioid Use Disorder in their practice if permitted by applicable state law…”

Despite the X-Waiver no longer being mandatory, the Act did enact a new training requirement. In Chapter 6 of the Act is Section 1263 entitled “Requiring Prescribers of Controlled Substances to Complete Training”. It discusses ways to meet training requirements, such as prescribers completing no less than 8 hours of training on the treatment and management of patients with Opioid Use Disorder in a variety of settings. Currently, DEA and SAMHSA are working together to implement the new training requirement and state that this requirement will not go into effect until June 2023.

PAAS Tips:

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  • PBMs and third-party payors are often mute on these topics, leaving pharmacies guessing on appropriate actions (and corresponding audit risk)
    • Comply with state and federal requirements for controlled substances
    • For prescriptions written prior to 12/29/2022, ensure the XDEA number is present on the prescription
    • If the pharmacy is filling/refilling a prescription written prior to 12/29/2022 and the provider did not have an XDEA number at the time, the prescription would likely be considered invalid by PBMs (and the DEA), and PAAS would suggest [conservatively] to get a new order from the provider

Beware: Caremark is Monitoring High Quantity Utilization and Atypical Dispensing Habits

Beyond traditional desktop, on-site, investigational or invoice audits, Caremark performs various compliance reviews. These compliance reviews may include:

PAAS National® has recently reviewed a second round of these Rx Claim Review notices from members. While new for Caremark, PAAS has identified multiple versions of the letter primarily focusing on two areas of concern:

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  1. Dispensed quantities of medications that are significantly higher than the average fill size
    1. Primarily seen with Diclofenac Gel 1%, Lidocaine 3% cream, Ketoconazole 2% cream and diabetic testing supplies (i.e., lancets, needles, strips, and syringes)
  2. Atypical dispensing activity (e.g., disparate prescriber to pharmacy ratio)
    1. Primarily seen with Duexis® and Pennsaid®

The brief, and poorly worded, letter states the pharmacy should evaluate the claims in question and consider whether the dispensing of these medications is appropriate. It concludes with “your cooperation is appreciated and will greatly assist us in our review”. Due to the ambiguous direction, pharmacies are unsure if they need to respond or provide any additional information or documentation to Caremark.

PAAS Tips:

  • The notices PAAS has reviewed do not require a formal response
  • Caremark wants the pharmacy to evaluate the claims
    • For claims listed as having a high quantity utilization, pharmacy can verify the quantity and days’ supply dispensed for appropriateness
    • For claims listed as having atypical dispensing habits, pharmacy should validate the claims are billed under the correct prescriber, that there is a valid physician-patient relationship, and that the prescriptions are not being solicited
  • Every pharmacy’s situation is different and PAAS can help provide perspective and next steps
  • See Caremark Expands “Aberrant” Language & Restricts Bulk Purchases from February 2022 Newsline for additional information on Aberrant Practices and Trends

Valid Prescriber/Patient Relationships and Marketing Concerns

With the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) recent focus on telemedicine fraud, pharmacies may be wondering what their obligations are when determining a prescription’s authenticity – especially when it comes to whether a valid prescriber/patient relationship exists. Many PBMs, including Express Scripts, TRICARE, CVS Caremark, and OptumRx all have language in their provider manuals placing the responsibility on the pharmacy of ensuring a valid prescriber/patient relationship exists.

How can you determine if a prescriber/patient relationship is valid? Questions you may ask to verify this are:

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  • Does the patient regularly see this prescriber?
  • Does the patient live in the same area where the prescriber’s office is located?
  • Would you be able to obtain medical records to validate this relationship if needed?
  • Can you confirm the patient is aware of and requested the prescription?

Along with telemedicine, PBMs are also concerned about marketing practices of pharmacies. The provider manuals for Express Scripts, TRICARE, CVS Caremark, OptumRx, and Elixir all contain language surrounding what is not allowed and some, like Express Scripts, are known for using investigational audits to ensure compliance.

Prohibitions on certain marketing practices in these manuals include, but are not limited to:

  • Acquiring potential patients, either directly or from a third-party by referral, using door-to-door, telephonic or other cold-call tactics.
  • Obtaining the patient’s provider or billing information without the patient’s consent.
  • Using fraudulent, abusive, or deceptive television or internet advertisements or emails.
  • Contacting a patient or prescriber without a previously existing relationship.
  • Contacting or offering to contact a prescriber on a patient’s behalf without the patient’s express knowledge and authorization.
  • Obtaining a prescription from a prescriber by suggesting to a patient that the prescriber or patient’s health plan wants the patient to receive the medication without the prescriber’s knowledge and authorization.
  • Limiting a patient’s right to use a different pharmacy of the patient’s choice or use marketing techniques that may make a patient believe they are restricted to your pharmacy.

Pharmacies must remain vigilant and always conduct marketing practices in a manner consistent with their state laws, federal laws, and Medicare regulations and guidelines.

PAAS Tips:

  • Make every effort to confirm a patient authorized prescriptions coming from unusual prescribers
    • Consider, amongst other things, the prescriber’s scope of practice and location to patient/pharmacy
  • Know your state and federal laws surrounding marketing practices
  • See the Medicare Communications and Marketing Guidelines for specific guidance
  • Develop policies and procedures surrounding marketing practices to ensure compliance
  • See the following Newsline articles for additional tips:
  • To get started with your customizable FWA and HIPAA Compliance program contact PAAS National® today, (608) 873-1342 or info@paasnational.com.

Top 10 PAAS National Articles of 2022

PAAS Audit Assistance members receive a monthly newsletter with new audit tactics and prevention tips. The printed newsletter, PAAS National® Newsline is only a fraction of the content that we put out each month as members have access to additional content online in the Member Portal, in addition to an archive of articles.

The top 10 Newsline articles for 2022 include:

  1. Use and Posting of Guidance Documents by DEA – What’s Changed with Controlled Substance Annotations?
  2. Mounjaro™ Off-Label Use for Weight Loss Spells T-R-O-U-B-L-E
  3. Risks when Filling a Prescription with Two NDCs
  4. Breaking Insulin Pen Boxes: Where Are We Now?
  5. Understanding Caremark’s Restrictions on Bulk Purchases
  6. When Should I Obtain a Diagnosis Code for Ozempic?
  7. Top Medications Flagged for Unauthorized Substitutions
  8. Cash Copy Collection
  9. Caremark® Expands “Aberrant” Language & Restricts Bulk Purchases
  10. COVID-19 OTC Home Test Kits Required Coverage as of January 15, 2022

Top eNewsline Exclusives: Articles that did NOT make print

PAAS Audit Assistance Admins can also keep their employees informed to increase engagement and lower audit results by adding employees to the Portal so that their whole staff has access to the eNewsline.

Natesto® Nasal Gel Pump – Bill It Right!

Pharmacies have begun to see more prescriptions for Natesto® (testosterone) nasal gel. Natesto® is indicated for primary hypogonadism and hypogonadotropic hypogonadism, whether those conditions were congenital or acquired. At this time, it is not approved for age-related hypogonadism or for male patient populations less than 18 years old.

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NDC NCPDP Billing Unit and

Package Size

 Number of Actuations

in Package

 Sprays Per Day
42667-5511-01 7.32 gm (Tube) 60 6

The recommended dose is 11 mg of testosterone (5.5 mg testosterone per nostril actuation) three times daily, preferably at the same time daily. Therefore, each package should be billed as a 10 days’ supply and a quantity of three packages would be dispensed for a 30 days’ supply, if prescribed as such. Despite needing to prime prior to initial use, no priming is necessary for the remainder of use and priming does not need to be factored in when computing the billed days’ supply.

PAAS Tips:

  • Natesto® is a Schedule III controlled substance. Ensure the hard copy is adherent to both your state and DEA requirements
  • Prescription should contain specific dosing, including indicating “in each nostril”, and frequency of use
  • Despite the package indicating “total contents: 11 g/ dispenser”, ensure your computer system accurately reflects the proper NCPDP billing unit and package size
  • Reference the PAAS Nasal Inhalers chart on the PAAS Member Portal

The Ballad of Snowbirds and Audits

The winter months have many pharmacies mailing prescriptions to their snowbird patients who leave their northern nests for more hospitable climates. Pharmacies want to keep these patients happy and coming back when the weather is nicer and may look to mailing maintenance medications to them when they have migrated out of state. Although these pharmacies may think they are doing the right thing for patient care, and their business, they may also be setting themselves up for audit failure.

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Unfortunately, this does not just apply to northern states with snowbird patients. Many states now have laws that require nonresident pharmacies to obtain a license to ship, mail, deliver, or dispense prescription medications into their states. Auditors take advantage of these laws to recoup money from well-meaning pharmacies who may not even know that mailing a prescription out of state is a problem! For pharmacies situated close to the state border, delivering into a neighboring state carries the same risks. PAAS National® has seen these claims cited as law violations with limited appeal options.

PAAS Tips:

  • Before mailing/delivering prescriptions out of state, it is a good idea to check with that state’s Board of Pharmacy to see if there are any licensure requirements for doing so.
  • Be aware of your contract obligations and which PBMs do not allow mailing of prescriptions to patients.
  • The COVID-19 pandemic had many PBMs make concessions to allow mailing during the Public Health Emergency (PHE). Keep up to date on concession expirations by downloading the PAAS COVID-19 PBM/Payers Concessions Chart.
  • Ensure you can prove, on an audit, the patient received their medication with tracking information that links to the prescription. See the January 2022 Newsline article, Mailing Prescriptions: How Do You Prove Patient Receipt?
  • Know the rules surrounding automatic mailing, especially for Medicare Part D patient, and review the September 2022 Newsline article, Automatic Mailing for Part D Patients, for specific information.

Start of New Year = Opioid Plan Rejects

PAAS National® analysts receive numerous calls at the start of the new year looking for guidance on opioid plan rejects. With the new year, many patients may be on a new Medicare Part D plan. Opioid prescriptions processed previously with no issues, may now reject at point-of-sale on the new plan.

With the opioid crisis on the rise, CMS acted in 2018 to closely monitor opioid use and safety of patients. Medicare Part D plans were required to implement opioid policies and work together with patients, prescribers, and pharmacies with this monitoring. These policies included real-time safety alerts at the pharmacy’s point-of-sale.

Here are the four Medicare Part D opioid safety alerts:

  1. Seven-day supply for opioid naïve patients
  2. Exceeding maximum dose of morphine to 90 MME (morphine milligram equivalent), including cumulative dosing
  3. Concurrent use of opioid and benzodiazepine
  4. Optional alert can be implemented by plan for cumulative opioid daily dose of 200 MME

In August of 2022, CMS through the Medical Learning Network (MLN) published A Prescriber’s Guide to Medicare Prescription Drug (Part D) Opioid Policies. This guide offers guidance to both prescribers and pharmacies for patients using opioid medications. Pharmacies should note, alerts that cannot be resolved at point-of-sale may require providing patients with a copy of the CMS-10147 Medicare Prescription Drug Coverage and Your Rights form. This form provides instructions for patient to work with their prescriber and their Medicare plan to expedite coverage for their medication.

Pharmacies have an obligation to

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follow plan alerts and guidelines for the safety of patients. Bypassing these restrictions not only put claims at risk of recoupment, but further scrutiny of your controlled substance dispensing practices. Split billing opioid prescriptions (i.e., billing part to insurance and cash payment for the remainder) is considered bypassing. When claims are not accurately billed to the Medicare D plan, proper monitoring cannot be done. PAAS does not recommend pharmacies split bill prescriptions to resolve rejects.

PAAS Tips:

  • Call plan for overrides or prior authorization when appropriate
  • Consult with prescribers about safety alerts and possible resolutions, e.g. changing medication or completing prior authorization paperwork
  • Prescribers unwilling to work with the pharmacy could be a red flag for the clinical appropriateness of their prescribing
  • PBMs can monitor and flag prescriptions that bypass plan limits
  • Charging the patient cash and not submitting claims could be considered non-compliance with the provider manual and could lead to network termination
  • Involving the patients in the resolution process may be necessary
  • See the CMS Medicare Part D Opioid Policies: Information for Pharmacists