Automatic Prescription Refill Concerns

Many pharmacies use an automatic refill process to streamline the labor needed to fill prescriptions. Patients tend to have better adherence to taking their maintenance medications when automatically refilled, and inventory management can be smoother as well.

Unfortunately, automatic refills can also lead to waste or abuse if not managed properly.

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This is why many state Medicaid plans do not allow automatic refills for their patients. MO HealthNet was just the latest Medicaid plan to prohibit automatic refills citing the following observations:

  • Participants receiving medications that were discontinued months prior;
  • Multiple strengths of the same medication when the prescriber changed doses but the pharmacy continued to autofill both;
  • Multiple products in the same drug class when the prescriber changes medications, but the pharmacy fills the old and the new medication; and
  • Pharmacies filling “as needed” medications each month, including migraine medications, rescue inhalers, and COVID tests, among others.

Unfortunately, PAAS National® has assisted with audits where the PBM is requesting proof of refill request. They required pharmacies to have a system in place to document that a patient requested a refill and note the date of request. Some of these audits were for Medicaid plans, some were simply audits where the patient had denied requesting the medication be filled possibly due to the patient misunderstanding the request by the PBM. In these cases, it is up to the pharmacy to prove that they filled the medication in accordance with a patient’s wishes.

PAAS Tips:

  • Be aware, state pharmacy regulations may prohibit, or require additional documentation for, automatic refill programs
  • Medicare B requires Proof of Refill Request for supplies that are mailed and delivered, to confirm patient need and proof of exhaustion for previous supplies
    • Contact PAAS if you need a template
  • Avoid putting bulk items like inhalers, insulin, eye drops or topicals on med sync
  • Do not put “as needed” or controlled substance medications on med sync
  • Ensure the refill interval is at ≥ 90% utilization
  • If employing a med sync program, review our August 2022 Newsline article, Medication Synchronization: Possible Concerns
  • Read the September 2022 Newsline article, Automatic Mailing for Part D Patients, for more information

NADAC Survey: What is It and Do I Need to Respond?

Pharmacies that receive a National Average Drug Acquisition Cost (NADAC) Survey frequently contact PAAS National® for information and guidance. While this survey remains voluntary, pharmacies may want to take a minute to understand what the survey is about.

The Affordable Care Act required that Medicaid programs shift pharmacy reimbursement to an acquisition cost-based model. CMS Final Rule (CMS-2345-FC) set a compliance date for State Medicaid Programs to be effective no later than April 1, 2017.

The NADAC file was created to provide pricing files for state Medicaid agencies to utilize when creating their acquisition cost-based pricing methods for Fee-for-service (FFS) Medicaid plans.

CMS has contracted Myers & Stauffer, LC to conduct these retail pricing surveys. Out-patient pharmacies are randomly selected to receive these surveys, requesting invoices for purchases made over a one-month period. The data collected from these invoices are used to update the NADAC file on a weekly basis.

Again, these surveys are currently voluntary, and pharmacies are under no obligation to respond. This however may change with a newly introduced bill, Drug Pricing Transparency in Medicaid Act of 2023 (H.R. 1613). If passed, this bill would not only make the surveys mandatory for pharmacies to respond but includes many updates to ban spread pricing in State Medicaid Plans. PAAS will keep you informed if, and when this bill passes.

PAAS Tips:

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  • NADAC files are published monthly here
  • Consider responding if you are being paid below your cost on Medicaid claims; your actual costs can be added to the survey data
  • Pharmacies may want to consider requesting a Non-Disclosure Agreement from Myers & Stauffer LC
  • Steps to take with your documents if responding
    • Print “Confidential” on each invoice page
    • Only include the documents requested, no PHI should be included
  • Contact Myers & Stauffer LC helpdesk with any additional questions (855) 457-5264

Caremark Invoice Audits – Pharmacy to Pharmacy Purchases

PAAS National® continues to see PBM audits increase as we get further out from the formal end of the COVID-19 Public Health Emergency. One disturbing trend is the number of invoice audits, particularly from Caremark. Oftentimes, Caremark will conduct a “combination” audit where they request copies of prescriptions and signature logs (a traditional desk audit) along with a request for pharmacy invoices that generally cover a 12-month period.

These audits are very large in size and scope, and we have noticed a new twist in enforcement on the invoice audits. Caremark outlines pharmacy network requirements for purchase invoices in the Pharmacy Provider Manual Section 8.05. Caremark states the following,

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For those Covered Items received from other pharmacies, where permitted by and consistent with Law, Provider must obtain and maintain the entire Transaction Statement, Transaction History, and Transaction Information from the selling entities.

This mandate exceeds the federal DSCSA requirements that would otherwise allow pharmacies to make purchases from other pharmacies on an occasional basis under a “specific patient need” exception and NOT require communication of the 3Ts, comprised of Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS). PAAS strongly opposes this requirement and will work with pharmacies to vigorously appeal any such invoice audit discrepancies.

Many pharmacies shop around for the lowest cost of goods and have purchased products from other pharmacies under DSCSA’s specific patient need exemption. Remember that this exemption is intended to permit occasional (not routine) purchases to avert patient harm due to supply chain shortages, as patients may be harmed by not getting access to prescribed therapies. Pharmacies with higher volumes of these purchases may be accused of purchasing outside of the specific patient need exemption and buying for general stock, which is not in compliance with DSCSA. Purchasing from other pharmacies can introduce risk that product obtained is illegitimate and could cause patient harm.

While FDA’s track and trace law (DSCSA) is not yet fully operational and many stakeholders are requesting that FDA delay enforcement (including APhA, NACDS, and NCPA), it seems that Caremark is trying to slap on an enforcement badge and bully pharmacies around in the meantime.

PAAS Tips:

  • Ensure that any pharmacy to pharmacy purchases qualify under DSCSA exemption of specific patient need
  • See December 2022 Newsline article, Pharmacy to Pharmacy Inventory Transfers – Buyer Beware! for additional discussion of risk and best practices for documenting such transactions
  • Please alert PAAS if you are subject to an invoice audit so that we can help you navigate the process as smoothly as possible

Are You Ready for Flu Shot Season? Auditors Are!

It is that time of year again; flu shot season is upon us. As busy as this season can be, we know you do not want to worry if you have all the documentation you need in case of an audit. Make it easy on yourself by ensuring you are ready now by following PAAS National®’s best practices to reduce your risk of audit recoupment.

What you will need for an audit:

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  1. Authority to administer
  • A signed order from an authorized prescriber
  • A signed protocol that is up to date and includes specific vaccination(s) to be administered or a Collaborative Practice Agreement (CPA)
  • When using a protocol or CPA, create a placeholder prescription with all prescription elements
  • In states where pharmacists have independent authority to vaccinate, create a placeholder prescription with all prescription elements
  1. Vaccination Information Statement (VIS)
  • Required to be given to patient prior to each administration
  • Be sure you have the most current VIS forms
  1. Screening Checklist
  • Not requested by PBMs, however should be retained for your records
  1. Vaccination Administration Record (VAR)
  • Date of Administration
  • Name of vaccine administered and manufacturer
  • Lot and Expiration Date of vaccine given
  • Site of administration (i.e. right arm)
  • Signature or initials and title of person administering
  • What VIS form was given
  • Date printed on the VIS
  • Date the VIS was given to the patient or parent/guardian

VAR and VIS forms, and information regarding what the CDC requires for health care providers to record, can be found on the CDC website.

PAAS Tips:

  • Check dates and vaccine types on your protocols to ensure they are up-to-date
  • Have current VIS forms printed for each vaccine you administer
  • Have VAR forms printed and educate all staff on how to complete the forms
  • All vaccines should be submitted using days’ supply of “1” per NCPDP recommendations
  • All vaccines administered via protocol should be submitted with origin code of “5” (pharmacy created) per NCPDP recommendations
  • Be sure correct metric quantity is billed
  • Keep vaccine documents stored in a system that makes access easy in case of an audit
  • When billing for vaccine clinics, DO NOT bill prior to the vaccine being administered
  • You may submit claims after the date of service, but the date of administration must be correct on the claim
  • PAAS has seen pharmacies flagged for billing claims outside regular pharmacy hours – consider billing for vaccine clinics during regular business hours

When Are Final Audit Results Not Final?

Receiving audit results with discrepancies and financial recoupments can be very discouraging. PAAS National® analysts are here to assist you through the appeal process. Audit results do not always provide all appeal options, and you don’t want to miss out on another chance if your initial appeal is denied.

Each PBM has different requirements for appealing discrepancies and different timeframes for when responses must be received. The appeal guidelines can also vary due to State audit laws. Engaging PAAS as soon as possible can make a big difference. PAAS analysts have years of experience with the audit appeal process and can provide information and recommendations to obtain the best possible outcome.

Many pharmacies give up when auditors do not accept appeal documentation and leave the fight too soon – check with your PAAS analyst to ensure you have exhausted all options. One example;

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OptumRx allows pharmacies a one-time opportunity to request a reconsideration with the Pharmacy Audit Review Committee (PARC). This committee is comprised of pharmacists and other professionals that have not previously been involved with the audit.

Here are some considerations for appealing OptumRx audits to PARC:

  1. Reconsideration is only available if pharmacy appealed initial findings
  2. Pharmacies must request an audit review form and instructions by emailing PARC@optum.com
  3. Pharmacies that are under investigation for suspected fraud, waste or abuse or appealing termination are exempt from this reconsideration
  4. Documents for reconsideration must be received within 30 calendar days of final results
  5. OptumRx Provider Manual indicates no new documentation can be submitted to PARC for review, however PAAS recommends providing everything you can as a last-ditch effort to support your claim(s)
  6. Pharmacy may have financial recoupments prior to the outcome of the PARC process
  7. Results from the PARC review can take up to 120 days
  8. Visit the OptumRx Provider Manual, Section VIII Compliance; Fraud, Waste and Abuse; General Training; Audits

PAAS Tips:

  • Engage PAAS early by sending your audits in as soon as you receive them
  • If PAAS did not assist you pre-audit, we can still assist with the appeal process
    • PAAS always wants to see your audit results, good or bad
  • Time matters, so stay on top of audit and appeal deadlines

Recent DEA Rule Change – Partial Fills for Schedule II Controlled Substances

The DEA recently updated the rule regarding partial fills of Schedule II (C-II) prescriptions. Pursuant to the Comprehensive Addiction and Recovery Act (CARA) of 2016, pharmacies are allowed to partial fill any C-II (e.g., stimulants, opioids, etc.) at the request of the prescriber, or the patient, as long as all the following criteria are met:

  1. Partial filling is not prohibited by State law.
  2. The prescription is written and filled in accordance with the Controlled Substance Act.
  3. The cumulative quantity dispensed from all partial fills does not exceed the total quantity prescribed.
  4. If the remaining portion of the partial C-II is filled, it must be filled no later than 30 calendar days after the written date of the prescription; except if the prescription was an emergency oral prescription, then the remaining portion must be filled no later than 72 hours after it was issued and if it cannot be completed, the pharmacy must notify the prescribing practitioner (see Long Term Care Facility (LTCF)/terminally ill exception in PAAS Tips below).

The change to 21 CFR 1306.13 (effective August 21, 2023) addresses regulatory requirements not previously addressed in CARA, such as how the prescribing practitioner should indicate the C-II should be partially filled, and how the pharmacist should record the partial fillings.

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Prescriber Requested

The DEA rule clarifies that a prescriber “must specify the quantity to be dispensed in each partial filling on the face of the written prescription, in the written record of the emergency oral prescription, or in the record for an electronic prescription”. Additionally, a pharmacist may contact the prescriber after receiving a prescription without a partial fill annotation if the pharmacist believes a partial fill is appropriate, but they do not wish to seek approval from the patient. If the prescriber authorizes the partial fill, “the pharmacist must note the following: “Authorized by Practitioner to Partial Fill,” the name of the practitioner, the date and time of the discussion, and the pharmacist’s initials”.

Patient Requested

The rule also clarifies that the patient, a parent or legal guardian of a minor (under age 18), or an adult patient’s medical power of attorney may request a partial fill. Their request to partial fill may be received via phone or by sending a signed written note to the pharmacy with a family member. “DEA does not interpret the CARA to allow any ‘assumption’ for a justification of a more limited dispensing than originally requested,” therefore, if a partial fill is desired, the request must be made for each C-II prescription. For partial fills, the pharmacist must record “(1) “The [patient, parent or legal guardian of a minor patient, or caregiver of an adult patient named in a medical power of attorney, whichever is applicable] requested partial fill on [date such request was made],” and (2) the quantity dispensed”.

When partial filling C-II prescriptions pursuant to CARA, the DEA clarified that the pharmacist must record the following elements:

  • Quantity Dispensed: On the face of the written prescription, in the written record of the emergency oral prescription, or in the record of the electronic prescription -OR- the recordkeeping for a written prescription or an emergency oral prescription can be maintained in the pharmacy’s electronic recordkeeping system
    • Caution: if the partial fill is not pursuant to the prescriber or patient’s request, but instead pursuant to the pharmacy’s inability to supply the full amount, an LTCF patient, or a terminally ill patient, then documentation must occur on the face of the written prescription, in the written record of the emergency oral prescription, or in the record of the electronic prescription
  • ALL Partial Fills: The pharmacy must have a record with “the date of each dispensing, the name or initials of the individual who dispensed the substance, and all other information required by 21 CFR 1306.22(c) for schedule III and IV prescriptions” such as:
    • drug name
    • dosage form
    • date filled/refilled
    • quantity dispensed
    • initials of dispensing pharmacist for each refill
    • total number of refills for that prescription
    • Note: For an electronic prescription, the quantity dispensed, date dispensed, and the dispenser must be linked to the electronic prescription

PAAS Tips:

  • Download, print and reference the new PAAS Tool the Partial Fill Chart for C-II Controlled Substances to guide you through the different types of partial fills, the documentation requirements and the timeline for how long you have to dispense the remaining quantity on the prescription
  • Document all requests! If the prescribing practitioner requests a partial fill of a C-II, but the patient requests a smaller amount to be partial filled, the patient’s request to partial fill must be documented in addition to the prescriber’s request
  • A patient may not request a partial fill which is larger than the partial fill quantity authorized by the prescriber
  • If a partial fill is requested by the prescriber or the patient, but the pharmacy must dispense a smaller amount due to availability of stock, the pharmacy’s need to partial fill the quantity must also be documented
  • Remember the varying length of time the remaining portion is available on a partially filled prescription:
    • Partial fill due to limited quantity: If the prescription was partial filled due to the pharmacy being unable to supply the full quantity, then the remaining balance must be dispensed within 72 hours or the remaining balance is void
    • Long Term Care Facility (LTCF) patient or a terminally ill/hospice patient: If the prescription has “LTCF” or “terminally ill”, respectively, documented then the remaining portion is valid for 60 days from the written date of the prescription
    • CARA: If the partial fill was pursuant to CARA, the remaining portion must be filled within 30 days of the written date of the prescription (Be aware of laddered C-II prescriptions, as the subsequent prescriptions issued by the practitioner may fall outside the scope of CARA if they do not fall within the 30-day window of when the prescription was originally issued)
  • Do not partial fill simply to bypass plan limits; for example, OxyContin® 40 mg tablets, 1 tablet by mouth TID; #90
    • #90 should be billed for a 30 days’ supply
    • If the plan rejects the claim stating only two tablets are allowed per day, the pharmacy should not partial fill #60 for a 30 days’ supply to circumvent the rejection
    • Instead, the pharmacy should follow up with the prescriber for a prior authorization or a change in therapy
  • Follow all applicable State requirements for controlled substances (e.g., defacing C-II, alphanumeric quantities, etc.)

Easy Audit Recoupment Prevention: Document Changes in Quantity Dispensed

When you think about preventing recoupments, ensuring the correct NDC is billed, the prescription contains calculable directions, and proper DAW or days’ supply are common focuses; and rightfully so. However, there is another element to be aware of when filling prescriptions: documenting when the dispensed quantity is different than the quantity prescribed.

Why?

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PBMs have attempted to recoup claims where the quantity dispensed was decreased or increased from the quantity prescribed when there was a lack of documentation to substantiate the change. PBMs may believe pharmacies are trying to accumulate more dispensing fees or bypass plan limits when pharmacies are dispensing a smaller days’ supply compared to what was prescribed. Conversely, if state law and/or prescriber approval allows, increasing the quantity dispensed puts the pharmacy at risk for exceeding the total amount prescribed by the doctor.

Additionally, pharmacies need to be mindful about their contractual obligations with PBMs. As discussed in the September 2022 Newsline article Prescription Quantity Changes Require Documentation, PBMs may have extended days’ supply agreements laid out in their contracts with pharmacies, requiring them to make “commercially reasonable efforts” to dispense more than 30 days’ supplies on medications. As a result, lack of documentation could lead to a situation that PBMs believe the pharmacies are violating their contracts and could end up with decreased reimbursement or required corrective action plans.

How to document?

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Fortunately, the documentation required does not need to be elaborate. A clinical note that contains “patient requests 30 days’ supply” or “medication synchronization patient” to explain the decrease in quantity dispensed should suffice. If prescriber approval is obtained and/or your individual board of pharmacy gives pharmacists the authority to increase, a clinical note with “prescriber approves 90 days’ supply” or “increased quantity per state regulation xx.xx” to explain the increase in quantity dispensed are examples of acceptable documentations.

Here are some additional considerations and PAAS Tips when changing the quantity dispensed:

Decreasing Quantity Dispensed

  • If the medication is required to be dispensed in its original container per packaging requirements, document “per manufacturer, must be dispensed in original container”
  • Changing the quantity to circumvent a plan limit or negative reimbursement are not valid reasons to dispense a quantity less than prescribed and could result in full recoupment of claims or a contract violation that may warrant further action

Increasing Quantity Dispensed

  • If your state law allows for the quantity dispensed to be increased independent of prescriber approval, document “increased to 90-day supply per state regulation xx.xx” with a date and pharmacist initials
  • If your state law requires the prescriber to be contacted for approval of an increased quantity to be dispensed, ensure you make a clear clinical notation that includes the date of the correspondence, name and title of the individual who you spoke to, message communicated, and your initials
  • Be mindful of the total quantity prescribed on prescriptions since you cannot dispense over that total amount over the life of the prescription.
    • For example, consider a prescription that was written for a quantity of 3 mL with 4 additional refills. The total quantity prescribed is 15 mL. Therefore, if your pharmacy does not break insulin boxes (which remains PAAS’ guidance at the time of this publication), you are only able to dispense the one full box with no additional refills. Pharmacies have the following options:
      • Dispense the full 15 mL and send a refill request to the prescriber for a new prescription on the next fill (assuming your state allows for the pharmacist to increase the quantity dispensed; and they have documented accordingly)
      • Contact the prescriber to verify the quantity and refills on the prescription and document on the hardcopy via a clinical note

 

 

Migraine Medications Continue to Cause Headaches

As PBMs continue to monitor claims for migraine medications, PAAS National® continues to receive questions about billing and the audit risks associated with these claims. When billing a medication to treat or prevent a migraine, pharmacies often struggle with having the correct documentation recorded for audit purposes. Submitting accurate quantities and days’ supply, along with appropriate documentation to support these claims, are the biggest issue PAAS comes across during an audit. PBMs monitor, and flag, these claims due to excessive cost, quantities submitted, days’ supply and/or frequency of refills.

PAAS Tips:

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  • Check to be sure the dosage form is present and clearly indicated whether that be an oral tablet, oral disintegrating tablet (ODT), nasal spray or subcutaneous (SQ) injection
  • Vague instructions for use such as “Use as Directed” and “as needed” should always be clarified
  • Prescriptions written for more than one package of any dosage form should have the estimated number of headaches per week or per month, per the prescriber, documented on the prescription and on the patient label. This information allows the pharmacy to calculate an accurate days’ supply when submitting the claim.
  • Pay close attention to the FDA labeling for:
    • Indications and usage – some medications are used for the treatment of a migraine and others as a preventative treatment
    • Dosage and Administration – review the recommended dose, can the patient repeat a dose, is there a maximum number of migraines that can be treated per week/month
    • Be sure to bill the appropriate days’ supply. Ex: Provider orders 16 tablets of Nurtec ODT for preventative treatment. Using 1 tablet every other day would make this a 32 days’ supply, not 30 days’ supply
  • Here are some examples:
Drug FDA approved indications/usage Recommend dose Can patient repeat the dose? Maximum daily dose Billing Unit per package
Migranal Nasal Spray Acute treatment One spray in each nostril (must prime with 4 pumps prior to each use and discard 8 hours after it is primed) Yes, 15 minutes later No more than 4 sprays (2 mg) per 24 hours.

No safety studies for doses
> 3 mg/24 hours and 4 mg/7 days.

 8 mL
Nurtec ODT tablets Acute treatment 75 mg daily No No more than 18 doses in a
30-day period		 8 each
Preventative treatment 75 mg every other day
Ubrelvy tablets Acute treatment 50 mg or 100 mg Yes, at least 2 hours after initial dose 200 mg/24 hours and no more than 8 migraines in 30-day period 10 or 16 each

Please reach out to PAAS (608) 873-1342 or info@paasnational.com with any questions on how to bill for different migraine medications so you don’t end up with a headache!

PAAS Pit Stop: The Member Portal

The PAAS Member Portal is a wealth of information and resources, whether you are part of the Audit Assistance and/or  Fraud, Waste, & Abuse and HIPAA Compliance Program. To get the most out of your membership, keep an accurate and up-to-date employee list.

Audit Assistance members: ensuring each staff member is entered into the PAAS Member Portal, along with a separate email address, allows for the entire staff to receive the monthly Newsline with current audit trends, proper filling & billing practices, hot topics, and more. They also have access to search seven years of eNewsline articles in our archive. Additionally, staff will have access to PAAS’ Tools & Resources, with billing charts, guidance documents, and on-demand webinars.

Fraud, Waste, & Abuse and HIPAA Compliance Program members: keeping your PAAS Member Portal current allows you to stay compliant. PAAS completes daily OIG & GSA exclusion checks, which goes beyond the federal expectation of exclusion checks being conducted upon hire and monthly thereafter. It allows the admin and compliance officer to generate a report reflecting when each employee last completed their FWA and HIPAA training and exclusion list check for the specific time frame being requested from the auditor.

In addition, if the auditor is looking for a specific policy or procedure, you can download your pharmacy’s customized FWA/HIPAA compliance manual and print off the corresponding pages of the policy or procedure they are requesting. For onsite audits, utilize PAAS’ onsite credentialing checklist to cross reference policy sections in your manual the auditor may ask for. This provides the auditor with much of the compliance components looked for during an audit in a fraction of the amount of paperwork and time.

PAAS Tips:

Caution with Script Care Audits

PAAS National® has seen a rise in desk audits from Script Care. While this PBM may not be familiar to some pharmacies, we would like to share specific information they have been looking for on their audits.

Prescriptions we have frequently seen flagged discrepant are:

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  • DAW Code Error
    • This plan is very specific about the appropriate terminology on the prescription per each states’ guidelines. (e.g., “Brand Medically Necessary”)
  • REMS Requirements
    • Prescriptions that do not have appropriate documentation, including REMS requirements, are frequently flagged
    • Applicable medication guides
    • See the FDA website for REMS requirements
  • Clinically Inappropriate
    • Prescriptions for off-label use and dosage or instructions that are outside FDA guidelines may require current literature to validate the prescription

Script Care does not currently have a Provider Manual; however, PAAS has been informed that they plan to release one soon.

Remember to send in any audit request upon first receiving and a PAAS analyst will be happy to assist you through the audit process. You can send in your audits by fax (608) 873-4009, email info@paasnational.com or upload to our portal available on our website under Access Services.