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.)
Best Practices for Billing Vaginal Creams to Avoid Recoupment
PAAS National® analysts frequently receive questions regarding the proper billing of creams and ointments, an easy audit target for PBMs. This article focuses on vaginal creams due to their high cost, lack of sufficient instructions for use and plan limits that cause pharmacies problems. When a PBM auditor sees a claim for Premarin® or Estrace® vaginal cream, they see dollar signs and often take back 100% recoupment on not just one fill, but multiple refills. To help reduce the risk of an audit recoupment, please review the table and PAAS Tips below.
Here is an example prescription:
PAAS Tips:
PAAS Pit Stop: On-Demand Webinars
Over the last three years, PAAS National®’s President, Trent Thiede, has presented on-demand webinars, ranging from 15 to 45 minutes, to ensure our members gain the knowledge needed to avoid audits, stay abreast on the latest topics in the pharmacy world, and provide information on the more difficult topics in an easy-to-understand manner. During the live events, members are able to ask questions on the topics presented.
PAAS understands the busy and unpredictable nature of your day-to-day pharmacy practice, so we are happy to offer the recorded webinars on the PAAS Portal. It’s a great tool for training and developing staff, as well as keeping up with hot topics in the industry. If you have questions while watching the on-demand webinar, contact PAAS and we’ll be glad to assist.
PAAS strives to pick webinar topics that are relevant to our members, if you have suggestions, please contact us.
PAAS Webinars:
Ransomware Attacks – Is Your Data Protected?
Safeguarding electronic Protected Health Information (ePHI) is as important for a big Fortune 1000 company as it is for independent pharmacies. The HIPAA Security Rule was designed to be flexible to accommodate providers of different sizes and with varying scopes of practice; therefore, the size of your pharmacy does not matter…the Security Rule still applies. That means administrative, technical and physical safeguards are all required to protect patient information.
A recent breach at PharMerica Corporation should serve as a reminder to reassess your pharmacy’s own safeguards to help decrease the risk of a successful malicious cyberattack. According to the PharMerica breach notification posted online in the Maine Attorney General Data Breach Notifications database, the breach affected over 5.1 million people. The attack occurred between March 12 and March 13, 2023 and was discovered on March 21, 2023. A sample of PharMerica’s breach notification letter explained that hackers gained access to patient records including “name, address, date of birth, Social Security number, medications, and health insurance information”. A ransomware gang claimed to be behind the attack and when PharMerica did not pay the ransom to buy back their stolen data, the information was published online.
Administrative safeguards such as firewalls, anti-virus software, log-in monitoring and password management are just several examples of methods to protect ePHI. Here are several questions to consider about your own program:
PAAS Tips:
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.
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:
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:
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,
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:
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:
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:
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;
Here are some considerations for appealing OptumRx audits to PARC:
PAAS Tips:
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:
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.
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:
PAAS Tips:
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?
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?
Here are some additional considerations and PAAS Tips when changing the quantity dispensed:
Decreasing Quantity Dispensed
Increasing Quantity Dispensed