COVID-19 Vaccine: Are You Prepared to Administer?

Healthcare providers will play a key role when a COVID-19 vaccine becomes available. CMS has issued a set of toolkits for providers, states and insurers to help in preparation of administering the vaccine when it becomes available. Medicare has provided these resources to help increase the number of providers that can administer the vaccine and ensure ample reimbursement for administration. They have also made it clear to Medicaid and private insurers their responsibility to cover the cost of the vaccine at no charge to the patient.

If you are not a Medicare enrolled provider then you need to enroll as a mass immunizer or other provider type to be able to bill for administering the vaccine. Please review the toolkits to see if your pharmacy needs to update your provider type. The toolkits explain how a pharmacy can enroll and discusses the Medicare coding structure and reimbursement strategy.

Medicare has established administration payment rates for the 2-dose series at $16.94 for the initial dose, and $28.39 for the final dose – incentivizing pharmacies and other providers to make sure the patient comes back for the second dose.

PAAS Tips: 

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  • Read the enrollment section of the toolkit to see if your pharmacy needs to take any current action
  • You can enroll as a mass immunizer over the phone – call your MAC-specific enrollment hotline
  • CMS will update the toolkits as new information becomes available
  • Make sure your pharmacy is prepared and educated on billing and administering the COVID-19 vaccine

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FDA Guidance on Insulin Pens Puzzling

On October 13, 2020, the U.S. Food and Drug Administration issued a statement looking to clarify the intent of the November 2019 label revisions for insulin pens. The updated labeling contained “Dispense in this sealed carton” on insulin pen boxes and Section 16.2 of the package inserts state: “Dispense in the original sealed carton with the enclosed Instructions for Use.” PAAS National® Members should be familiar with our February Urgent Email Alert and subsequent Newsline articles in March and April.

Looking to get further clarity into the rationale for the labeling change, PAAS had submitted a Freedom of Information Act request to the FDA. In response, PAAS learned

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that a Tracked Safety Issue was opened for insulin pens back in June of 2018. Congruently, the clarification from this October recognizes the following concerns when breaking insulin pen boxes: medication errors (including wrong drug/dose resulting in hyper/hypoglycemia), missed doses, complaints of possible tampering, and dispensing without the Instructions for Use.

The October letter goes on to the following:

  1. Insulin pens are approved to be dispensed in their original sealed cartons
  2. Insulin pens are not labeled for dispensing as individual units
  3. Sealed cartons of insulin pens are intended to be dispensed to a single patient
  4. Each carton is sealed, with the intent to alert health care professionals and patients when it has been opened, individual insulin pens within the cartons do not have their own sealed package. The carton labeling and sealed packaging are important for both health care professionals and patients.
  5. The cartons help health care professional and patients differentiate between the insulin pens

However, to the bewilderment of many, the FDA also stated the following:

  1. The FDA claims the November 2019 revisions stated that health care professionals should dispense the pens to a single patient in the original sealed carton (note should, not must)
  2. The FDA understands there are situations where health care professionals may choose to dispense individual pens (outside of the carton), not in accordance with FDA-approved labeling, based on their own professional judgement
  3. Health care professionals should consider the known risks of dispensing individual pens, and incorporate additional safety measures (e.g. adding tamper-indicator tape, providing the Instructions for Use, and labeling individual pens for individual patient use)

So, what does this all mean for community pharmacies? More of the status quo – don’t break the box. While the FDA may “understand” and permit dispensing of individual pens on an exception basis, payers (and PBMs) may not. PAAS often sees PBMs hold pharmacies accountable for FDA labeling requirements (e.g. dispense in the original container medications). Moreover, pharmacists could incur additional liability by choosing to go against FDA labeling requirements despite warnings from the FDA.

PAAS Tips:

  • Pharmacies should always try to first bill an accurate days’ supply based on the prescribed quantity– many insurers have accommodated days’ supply limits well in excess of 90 days
  • If plan limits are exceeded follow the guidance below:
    • Multiple cartons – reduce the # of cartons and corresponding days’ supply until the claim will adjudicate. Document Insurance Limits Quantity (e.g. ILQ = 30 days) on the hard copy.
    • Single carton (in order of preference):
      • Call the PBM help desk and request an override
      • If no override is available, adjust the days’ supply to the Plan Limit

Members can view our eNewsline in the member portal for additional PAAS Tips.

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Foot Bath Prescriptions – MedImpact is Now the Fifth PBM Investigating

PAAS National® has alerted members through several Newsline articles of an increase in audits with Prime Therapeutics®, Caremark®, OptumRx® and Express Scripts® investigating foot bath prescriptions. MedImpact® has now jumped on the wagon as well. Topical products and injectables are commonly flagged for high quantities and dollar amounts. PBMs speculate these items are being used off-label due to the large quantities dispensed; and commonly seen in foot bath treatments.

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Prime Therapeutics® sent out a 2019 Newsletter stating the dilution of drug products in a foot bath changes the concentration and is thereby considered off-label as this has not been studied or supported to be effective. They require pharmacies to obtain clinical evidence to support the efficacy and safety of dispensing these products in foot baths.

Caremark® sent out provider manual updates for 2020 prohibiting the dispensing of high quantities or high volumes of drugs within a certain category (e.g. topical or dermatological products). Caremark® will monitor claims monthly and if a pharmacy bills 25% or more (in number of claims or dollars) of items on the aberrant product list, the pharmacy will be in a breach of contract. This list can be found on the Caremark Pharmacy Portal.

OptumRx® will mark foot bath prescriptions with a discrepancy code of CLN = no documentation to denote clinical appropriateness was validated.

Express Scripts® has sent out investigative letters referencing section 7.1 of the provider agreement. The pharmacy must respond by completing responses to questions in a letter.

Now, MedImpact® is issuing results with full recoupments on medications used in a foot bath. Their comments are: “Quantity and directions for use of drug appear to be for use in a foot bath. No clinical documentation or evidence exists to substantiate the clinical appropriateness of using this drug in a foot bath. CMS, in collaboration with the I-MEDIC, indicates Topical products are not the standard of care in treatment of foot infections such as diabetic ulcers, and could be actively harmful to the healing process. Further, the purported indications of use of these combinations used in this manner, may not be medically accepted indications (MAIs) and are, at best, investigative and experimental treatments.”

PAAS Tips:

  • Be aware that many PBMs are flagging high quantities of topical and injectable medications
  • Medicare Part D does not pay for off-label use
  • A claim for medication used in a foot bath may seem like a clean claim at adjudication, but it does not guarantee payment
  • PAAS advises against billing for topical or injectable products used in a foot bath without sufficient clinical evidence

BEWARE: Virtual On-Site Audits Are Coming!

If you haven’t already noticed, most of the PBMs have resumed auditing practices and started issuing on-site audits the first week of August; however, these are not the on-site audits that you are used to. To practice social distancing and protect your staff (and theirs) most PBMs and audit companies have revised these audits as “virtual” and borrowed some elements from traditional desk and on-site audits to create a new Frankenstein’s monster that shifts a large burden onto pharmacies.

While each PBM/audit company has their own unique nuances for these virtual audits, here are some general trends.

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Elements from traditional on-site audit method:

  1. You will be asked to respond to a host of compliance questions about your pharmacy operations – only by telephone instead of face to face. PAAS can help with the nuances for each PBM.
  2. The comprehensive On-Site Credentialing Guidelines tool available under the “Tools & Aids” portion of the PAAS National® Member Portal can also help prepare you.
  3. Most pharmacies report that these calls are about 20 minutes in length.
  4. The auditor may want to see numerous licenses and certificates to ensure that your pharmacy is following contractual requirements. Since they can’t visually observe these on your premises, you will need to submit copies.
  5. The auditor may want to see the physical layout of your pharmacy including consultation area, sink, refrigerator, compounding lab, parking lot and pharmacy robot. Again, since they won’t be at your pharmacy, they will expect you to take photographs.

Elements from traditional desk audit method:

  1. You will be asked to submit copies of prescriptions and signature logs via fax, mail or electronic portal – in some cases your documentation deadline is before the phone interview, while in others it may be after.
  2. Sample sizes tend to mirror onsite audits and could exceed 120 prescriptions and 100+ signature logs!
  3. Some PBMs have provided up to 45 days to respond to accommodate for larger sample sizes.

PAAS Tips:
  • Notify PAAS if you receive a virtual audit notice so that we can help guide you through the process from start to finish
    • It is best to send us all pages of your audit notice before you start retrieving any documents; we will guide you through what to pull (and what you do not need to pull)
  • If you are a PAAS National® Fraud, Waste, & Abuse and HIPAA Compliance Program member, you currently have trial access to the PAAS Vault – a license tracking tool that can keep all your certificates and licenses in one place, easily accessible and at your fingertips. Make sure to check it out on the PAAS Member Portal

Ozempic®– Bill It Right!

Ozempic® is an injectable used to improve glycemic control in adults with type 2 diabetes mellitus and is available as 2 mg in a 1.5 mL (1.34 mg/mL) pre-filled, disposable pen injector. Chart available on our eNewsline.

Ozempic® is dosed once weekly. The starting dose is 0.25 mg once weekly for 4 weeks, then increasing to 0.5 mg once weekly. If additional blood sugar control is needed after at least 4 weeks at 0.5 mg , the dosage may be increased to 1 mg once weekly. Due to the confusing billing units (mL) and titration schedule, billing can be challenging. Based on how each patient responds to treatment and their goals, there are a few different clinical scenarios that may occur following the initial 4 weeks on 0.25 mg. See our eNewsline for three patient scenarios.

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PAAS Tips: 

  • The NCPDP billing unit is “mL” so the 1-pen box is billed as 1.5 mL and the 2-pen box is billed as 3 mL
  • Submitted days’ supply should be in weekly increments based on the calculations
  • After first use, the pens can be stored at room temperature for 56 days

Defense Health Agency Money Grab for 2015 Prescriptions Involves Over 300 Pharmacies

June delivered a bombshell for over 300 pharmacies when Express Scripts recouped payment for TRICARE prescriptions dating back to 2015. These recoupments occurred before pharmacies were even notified, leaving many struggling to make payroll and pay wholesalers – in the middle of a Pandemic.

This was not your garden-variety audit, but rather an investigation of the pharmacies by the Defense Health Agency, Office of Program Integrity (DHA-PI). Pharmacies were not requested to produce any documentation in advance of the recoupments. This enforcement action was a result of DHA-PI’s inability to establish a valid patient-prescriber relationship (PPR), deeming the prescriptions written by these prescribers invalid.

Primarily hormone replacement therapy compounds, these prescriptions are not the pain and scar cream prescriptions that were wrought with fraud during that time (many averaging just $40/claim). Due to the absence of a billable office visit from the prescriber in the preceding year, DHA-PI concluded that a valid PPR did not exist – dismissing several plausible explanations. Most prescribers were local to the pharmacy and were prescribing non-compounding medication as well (which are not currently recouped). The lack of due process with this investigation is alarming and should concern all pharmacies.

The same week of the original notice, PAAS National® spoke with Express Scripts and DHA-PI to obtain additional details and help chart a course of appeal. We hosted a live webinar (available on the PAAS Portal) to share information and educate pharmacies on what was taking place. Keeping our members informed on the most up to date information as it becomes available to fight these recoupments is our priority. Partnering with NCPA and the Alliance for Compounding Pharmacies (APC), we continue to advocate and have conversations with DHA-PI and ESI; last occurring July 15, 2020.

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While the statement of patient-prescriber relationship is not often brought up during audits, Express Scripts did add information to Section 10, the TRICARE portion of their Provider Manual in 2017. Section 10.1.14 of the manual states it is the pharmacy’s responsibility to validate the patient-prescriber relationship if the prescriber is from outside the immediate retail pharmacy service area. Notably, pharmacies may also not be aware that TRICARE’s Return to Stock Policy is 10 days, which differs from Express Scripts 13-day policy. Having a separate section in the Express Scripts Provider Manual for TRICARE can make it very easy for pharmacies to overlook. PAAS encourages all pharmacies to take a closer look at Section 10 for TRICARE requirements.

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Authorized Distributors for Diabetic Test Strips

Invoice audits focusing on diabetic test strips are common in the PBM world. PAAS National® believes the PBMs and manufacturers have two purposes for requesting these invoice audits. They are checking for inappropriate billing practices (wrong NDC) and inappropriate sources of inventory (unauthorized distributor).

The newest audit PAAS has seen is coming from manufacturers of test strips that offer rebate contracts with pharmacies for Medicare/Medicaid claims. These audits are very similar to other PBM invoice audits, in that they request invoices from authorized distributors for test strips dispensed during the specified timeframe. Since the manufacturer knows the number of rebates paid, they can easily identify potential shortages. Pharmacies without a valid explanation will be required to repay their rebates and will potentially lose their ability to purchase Medicare/Medicaid-only test strips.

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Caremark® and Express Scripts® require test strips to be purchased directly from the manufacturer or from authorized distributors only. Manufacturer rebate agreements also have these same requirements. Purchasing diabetic test strips from unauthorized distributors puts your pharmacy at risk of audit recoupments, violation of provider agreements and possible network termination.

PAAS Tips:

  • Try to purchase test strips from one approved wholesaler
  • Be sure all strip claims are run for the correct NDC and pack size
  • Self-audit 5-10 claims at regular intervals for internal review

PAAS Audit Assistance members can view the full article on our eNewsline.

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Medicare Part B Requires a Claim Modifier If You Are Not Collecting Patient Signatures!

On March 13, 2020, the Secretary of the Department of Health & Human Services (HHS) authorized waivers under Section 1135 of the Social Security Act to relax certain administrative rules to ease burdens on Medicare providers and suppliers to more easily provide care during the COVID-19 pandemic. The “1135 blanket waivers” include, among other things, waiving the enrollment fee for Medicare B Providers for those pharmacies that want to provide COVID-19 testing and the requirement to obtain patient signatures for proof of delivery for DME Supplies such as diabetic test strips. These waivers are retroactive to March 1, 2020 and are effective until the end of the emergency declaration.

On April 6, 2020, CMS issued Interim Final Rules with Comment (CMS-1744-IFC & CMS-5531-IFC) and the DME Medicare Administrative Contractors (MACs) issued bulletins in late May explaining that suppliers must include a “CR” modifier and include a narrative of “COVID-19” for claims where patient signatures were not obtained as proof of delivery. Claims that do not include the modifier and narrative may be subject to denial.

Here is an excerpt from the DME MAC joint bulletin:

‘Suppliers should continue to use the appropriate modifiers, including the KX modifier where applicable, for all HCPCS codes included in the NCDs and LCDs listed above. In addition, the CR modifier (CATASTROPHE/DISASTER RELATED) should be added to the HCPCS code(s) billed. Finally, suppliers are instructed to enter “COVID-19” in the NTE 2400 (line note) or NTE 2300 (claim note) segments of the American National Standard Institute (ANSI X12) format or field 390-BM of the National Council for Prescription Drug Program (NCPDP) format. These abbreviations may also be used in Item 19 of the CMS-1500 claim form.’

If your pharmacy dispensed DMEPOS items and did not obtain a patient signature as proof of delivery on or after March 1, 2020, then you must include

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this CR modifier and COVID-19 narrative.

If you have already dispensed claims without this CR modifier and COVID-19 narrative, then you should file a reopening with the DME MAC to ensure that these claims are not subject to audit recoupments in the future. If you are unable to file a reopening and subsequently have claim denials during an audit, you will still have the full appeal process available.

PAAS has reached out to both DME MACs and they have confirmed that pharmacies should submit reopenings to adjust the necessary claims to include both the CR modifier and a narrative stating “COVID-19”.

PAAS Tips:

  • We suggest that pharmacies contact their DME claims processor (such as Change Healthcare, EZ DME, or OmniSYS) for technical support on how to include the CR modifier on appropriate claims
  • Pharmacies should contact their local DME MAC (CGS or Noridian) for assistance with filing claim reopenings
    • Reopenings may be available by telephone, in writing or electronically on the DME MAC portal
    • Reopenings may be completed within one year of claim submission
    • CGS Jurisdiction B (844-240-7490), Jurisdiction C (866-813-7878)
    • Noridian Jurisdiction A (866-419-9458), Jurisdiction D (877-320-0390)
  • For more information, you can review:

COVID-19 Audit Considerations Follow-Up

On April 3, 2020, PAAS National® sent an urgent email alert to all members discussing COVID-19 audit considerations. This email came as a result of our desire to help pharmacies on the frontlines of this pandemic.

If you did not receive our email, please see the COVID-19 Audit  Considerations memo for useful audit tips and guidance to avoid pitfalls. Emails were sent to the email addresses we have on file for your pharmacy and primary contact person. If your pharmacy missed the communication, please call or email us to update your account.

PAAS wants you to stay informed of PBM requirements to help keep your staff, patients, and business safe. Since mid-March, we have been advocating for and tracking reductions, and outright waivers, of specific PBM requirements, most notably:

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  1. Proof of Delivery Requirements (“signature logs”)
  2. Mail/Delivery Restrictions
  3. PBM Overrides
  4. Audit Postponements/Suspensions
  5. State of Emergency/Executive Orders

The pandemic is extremely fluid, with changing dynamics and daily updates from PBMs. We have analyzed over 40 PBM communications in the last couple of weeks (just looking at national plans), and it’s vital that pharmacies be vigilant on the fine print.

PBMs will continue to use any technical discrepancy to deny claims on an audit, and these temporary waivers only increase the likelihood that pharmacies will face recoupments. PBMs will be auditing this time period, specifically looking to recoup high dollar claims without supporting documentation – in FULL.

Be careful of waiver/concession expiration dates – there will be no leeway when it comes to auditing these claims after the fact. Pay close attention to PBM communications and save our summary chart link of current concessions; you’ll want to keep a close eye on changes.

Caremark Enforcement: Aberrant Quantities & Volumes

PAAS is starting to see Caremark enforce their new policy about Aberrant Quantities and Volume that we first wrote about in a December 2019 article Important: Caremark Provider Manual Updates for 2020!. These notifications state that pharmacies have breached the Provider Agreement and the pharmacy is receiving a formal breach notice as a warning.

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Caremark updated the Provider Agreement in November 2019 (effective January 1, 2020) to require pharmacies to dispense less than 25% of claims (by claim count or dollar amount) of select medications they consider to be at high risk for Fraud, Waste or Abuse. Exceeding this 25% threshold is deemed “aberrant” dispensing. Caremark states they will monitor pharmacies on a monthly basis and if you violate the 25% threshold after receiving a breach notice, you will be subject to claim recoupment and/or network termination.

While The Aberrant Drug List is unique to Caremark, all PBMs are auditing for these types of medications. PAAS has seen numerous examples of pharmacies losing claims during audits for soliciting prescriptions of these “special” dosage strengths. We advise pharmacies to be extremely cautious about this type of dispensing as it echoes the issue of repacking NDCs at inflated AWPs from the mid-2000s.

PAAS Tips:

  • The Aberrant Drug List was updated March 6, 2020
  • Current list is available on Caremark’s Pharmacy Portal at https://rxservices.cvscaremark.com