Medication synchronization (med sync) programs are common across pharmacies and yield many benefits. Patients can request it to manage medication better and reduce the number of trips needed to the pharmacy. Patient adherence increases and pharmacies can keep tighter control over inventory while having more efficient workflow.
NCPA promotes the improved adherence and quality of care through med sync programs. They call it a “once a month appointment day” for patients enrolled, saying pharmacist-patient dialogue increases with more time to focus on additional patient care services.
NCPA collaborated with the Arkansas Pharmacists Association to conduct a study measuring the impact of med sync programs on medication adherence and persistence across 82 independently owned pharmacies. The workflow tool was provided to the pharmacies by PrescribeWellness operating on 13 pharmacy management systems. Over 8,000 patients enrolled for this year-long retrospective cohort study. The key findings state that med sync patients are over 2.5 times more likely to be adherent to medications and 21% less likely to discontinue drug therapy. For more details, see the Study Overview and Full Report.
It’s a win all around – until it poses a waste or abuse issue. PBM audit algorithms are made to seek out fraud, waste, and abuse. PBMs will flag pharmacies for audit if claims are billed particularly early every month; for example, every 23 days on a 30 day’s supply.
PAAS National® recommends …
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having patients opt in for med sync with a signature that can be produced under audit, ideally with annual reverification. This way the pharmacy has evidence to support the patient requested enrollment. This enrollment should also include guidance on how a patient may ‘opt-out’. Med sync best practices also include a phone call [preferably documented] every month to affirm the refills needed prior to dispensing. Cycling the refills at ≥ 90% utilization can also help lower your risk of audit triggers from PBM algorithms that look closer at 75% utilization. Avoid putting bulk items on med sync, such as inhalers, insulin, eye drops or topicals. Med sync also shouldn’t apply to prescriptions written for as needed purposes or controlled substances.
PAAS Tips:
- State pharmacy regulations may prohibit automatic refill programs or require additional documentation
- Payer restrictions may apply for programs such as Medicare Part B/D and Medicaid
- Automatic mailing and delivery of prescriptions often have additional requirements
- Read Getting in Sync from NCPA’s America’s Pharmacist February 2024
- See also the Pharmacy Operations Manual for SimplifyMyMeds® from NCPA February 2018
FDA Approves First Rapid-Acting Insulin Biosimilar: MerilogTM (insulin aspart-szjj)
On February 14, 2025, the FDA approved the first rapid-acting insulin biosimilar, MerilogTM (insulin aspart-szjj) manufactured by Sanofi Aventis. MerilogTM is expected to reach the U.S. market in July 2025 and will require prescriber approval before pharmacies can substitute for other insulin aspart products such as Fiasp® or NovoLog®.
MerilogTM is the third insulin biosimilar approved by FDA (along with RezvoglarTM and Semglee®).
PAAS Tips:
Audit and Appeal Due Dates: Stay Ahead of the Clock with These Essential Tips
Pharmacy practice often revolves around meeting tight deadlines. Prioritizing can become challenging when you’re focused on providing prompt service to waiting patients or rushing to meet inventory ordering deadlines, all while managing your daily tasks. It’s tempting to push aside a PBM audit request, or its results, to tackle more immediate responsibilities. Unfortunately, neglecting audit or appeal due dates can lead to significant, and unnecessary, financial losses to the PBMs.
One of PAAS National®’s top priorities is helping pharmacies navigate the audit process successfully from start to finish. Remember to engage PAAS early by submitting your audit notice or audit results as soon as you receive them. Discussing your audit notice or results with your assigned analyst early can help you avoid unnecessary work when putting documentation together. This can also eliminate providing unnecessary information to auditors.
A great way to begin is by establishing a workflow process when audits are received. The following tips can assist you with a more efficient and effective audit outcome.
Step 1: Audit Notice or Audit Results Received
Step 2: Prepare your Documents
Prescription Documents
Signature/Delivery Requests
Proof of Copay Collection
Step 3: Submitting your Audit
Step 4: Audit Outcome
Audit Results and Appeal
PAAS Tips:
Mailing Prescriptions? How to Ensure Audit Success
While some pharmacies make mailing prescriptions a regular practice, others may only do so on a case-by-case basis. PBMs require signature logs to prove that a patient received their medication in a timely manner, but how is proof obtained when the patient is not standing in front of you at the pharmacy counter?
PBMs will require proof of delivery that contains information clearly showing what was in the package delivered. Most PBMs require a link between the delivery confirmation (via a tracking number) and the prescription record to show which prescription was being delivered. There should also be a patient signature or tracking detail from the carrier showing the date and location where the medication was ultimately received.
Notably, not all PBM agreements allow the mailing of prescriptions, while others may restrict mailing to a percentage. Humana and OptumRx typically prohibit mailing under retail agreements, and OptumRx further restricts delivery to within 100 miles by W-2 pharmacy employees. Caremark only allows up to 20% of their claims to be mailed.
Another consideration for pharmacies is ensuring you are licensed in any state you are mailing to. Many states have laws that require pharmacies to obtain a non-resident license to ship, mail, deliver, or dispense prescription medications into their states. Auditors look for these [expensive] claims to take advantage of well-meaning pharmacies who may not know of these requirements. Pharmacies located on state borders making deliveries into another state may also run into this problem as well.
PAAS Tips:
Audit Considerations for Med Sync Programs
Medication synchronization (med sync) programs are common across pharmacies and yield many benefits. Patients can request it to manage medication better and reduce the number of trips needed to the pharmacy. Patient adherence increases and pharmacies can keep tighter control over inventory while having more efficient workflow.
NCPA promotes the improved adherence and quality of care through med sync programs. They call it a “once a month appointment day” for patients enrolled, saying pharmacist-patient dialogue increases with more time to focus on additional patient care services.
NCPA collaborated with the Arkansas Pharmacists Association to conduct a study measuring the impact of med sync programs on medication adherence and persistence across 82 independently owned pharmacies. The workflow tool was provided to the pharmacies by PrescribeWellness operating on 13 pharmacy management systems. Over 8,000 patients enrolled for this year-long retrospective cohort study. The key findings state that med sync patients are over 2.5 times more likely to be adherent to medications and 21% less likely to discontinue drug therapy. For more details, see the Study Overview and Full Report.
It’s a win all around – until it poses a waste or abuse issue. PBM audit algorithms are made to seek out fraud, waste, and abuse. PBMs will flag pharmacies for audit if claims are billed particularly early every month; for example, every 23 days on a 30 day’s supply.
PAAS National® recommends …
having patients opt in for med sync with a signature that can be produced under audit, ideally with annual reverification. This way the pharmacy has evidence to support the patient requested enrollment. This enrollment should also include guidance on how a patient may ‘opt-out’. Med sync best practices also include a phone call [preferably documented] every month to affirm the refills needed prior to dispensing. Cycling the refills at ≥ 90% utilization can also help lower your risk of audit triggers from PBM algorithms that look closer at 75% utilization. Avoid putting bulk items on med sync, such as inhalers, insulin, eye drops or topicals. Med sync also shouldn’t apply to prescriptions written for as needed purposes or controlled substances.
PAAS Tips:
Respiratory Syncytial Virus (RSV) – What You Need to Know
There are currently three FDA-approved Respiratory Syncytial Virus (RSV) vaccines available for individuals at risk of severe illness from a respiratory virus. Please review the chart for helpful billing tips and the additional information below as to which RSV vaccine is appropriate to give to an eligible individual.
*Also available in 5 and 10 kit packages **Also available in a pack of 10 pre-filled syringes
The CDC recommends a single dose of any FDA licensed RSV vaccine be given to all adults ages 75 and older and adults who are between the ages of 60 and 74 who have an increased risk of severe RSV. The conditions that increase the risk of severe RSV can be found on the CDC website. The CDC also recommends pregnant women receive a dose of the maternal RSV vaccine (Abrysvo®) during weeks 32 through 36 of their pregnancy sometime between September through January. To prevent severe RSV in infants, it is recommended that the mother receive the maternal RSV vaccination or the infant receive the vaccination with RSV monoclonal antibody.
PAAS Tips:
Medicare Part A vs Part D Billing Risks – How to Protect Your Claims
Pharmacies continue to receive PBM audit notices for claim recoupments where the [allegedly] improper Medicare coverage was billed. Medicare Part A helps cover hospital, skilled nursing facility (SNF), and hospice care stays. Medicare coverage status is typically linked to the patient’s admission and discharge dates from a Part A stay.
When a patient is covered under a Part A stay, the facility providing the stay is typically paid a per diem for the medications, supplies, and services needed during the coverage period. This means that Medicare Part D cannot (and will not) be responsible for claims billed during that time. Unfortunately, PBMs typically do not have the information at the point of sale to stop these claims from being billed inappropriately, leaving pharmacies scrambling upon retrospective review/audit.
PAAS Tips:
Changing Pharmacy Management Software? Don’t Neglect Record Retention!
When updating or changing pharmacy management software systems, pharmacies may be presented with different options to archive the files from the software they will no longer be using. While it may not seem worth the extra cost now, ensuring that you are able to retrieve appropriate data for old claims is crucial to avoiding costly audit results in the future.
Does the option you are selecting ensure you’ll be able to easily retrieve and provide copies of any required information? Prescriptions, claim data billed to the insurance, signature logs, proof of copay collection and invoice records are all items that a pharmacy would need to be able to access whenever needed. Not only for auditing purposes, but to stay within contractual record keeping requirements as well. Medicare Part D rules require all records to be retrievable for 10 years, plus the current contract year; while Commercial plans, Medicaid, state, and federal requirements can all range from 2 to 7 years.
If you can produce documentation from your old system – great! Will the details pass an audit? Ensuring that prescriptions and other documentation from an old system have all necessary elements and are not missing things like unit of measure, clinical notes, or the pickup date on a signature log is important and can save a pharmacy from having to appeal. This is also a consideration when acquiring another pharmacy’s records. Be aware of potential audit hazards with newly acquired records. Origin codes, state transfer requirements and clear links to original prescriptions should be considered during the acquisition process.
PAAS Tips:
Verify Day’s Supply on CeQur Simplicity Meal-Time Insulin Patch
CeQur SimplicityTM is a meal-time insulin patch approved for use in adult patients (over the age of 21) with Type 2 Diabetes and can replace up to 12 meal-time insulin doses. The patch delivers rapid-acting insulin in 2-unit doses through a flexible cannula by depressing two buttons, one on each side of the patch.
This patch was originally cleared by the FDA for a 3-day wear time and could replace up to 9 meal-time insulin doses. According to the manufacturer’s website, the FDA cleared an extension in mid-2024, allowing the wear time to increase from three days to four.
PAAS Tips:
Updated Form Expiration 12/31/2027 – Medicare Drug Coverage and Your Rights Notice
The CMS-10147 Form, also known as the Medicare Drug Coverage and Your Rights Notice, must be distributed to Medicare Part D beneficiaries when a prescription is not covered at the point-of-sale. This notice informs beneficiaries about their right to contact their Part D plan to request a coverage determination, including an exception. The distribution of the CMS-10147 form is a requirement for all pharmacies, including mail order, specialty and LTC. While documentation is not required confirming distribution of the CMS-10147, your pharmacy should have a policy and procedure in place addressing how and when the form is being distributed to patients. PBM field auditors have been known to ask questions about your process and may ask to see a copy of the form to ensure you have the most up-to-date version.
On 02/11/2025, CMS issued a memo to announce the availability of a renewed Medicare Drug Coverage and Your Rights (CMS-10147) “Pharmacy Notice”. While there were no major changes made to the form, the Office of Management and Budget (OMB) approved a new expiration date for OMB Control # 0938-0975. The new expiration date is 12/31/2027.
PAAS Tips:
Forteo® Package Size Update – Compendia Adjustment Expected April 1, 2025
As previously reported by PAAS National® in our December 2024 Newsline article, the FDA revised the product labeling for Forteo® (teriparatide injection) and its generics to accurately reflect the amount of drug delivered to the patient and not the overfill existing in the pen injector delivery device (from a 600 mcg/2.4 mL pen to a 560 mcg/2.24 mL pen). Despite this adjustment, the NCPDP billing quantity and unit still reflected the previous 2.4 mL measure.
Because this change was due to a label correction, the FDA is not requiring the manufacturers to change the NDC number or recall the boxes labeled as 600 mcg/2.4 mL. The manufacturers will simply relabel the products to reflect 560 mcg/2.24 mL instead. While the newly labeled products were expected to enter the marketplace in February 2025, the metric quantity is not expected to be updated in the drug data compendia until April, giving the compendia time to accurately prepare for this change.
This may cause some pharmacies confusion if they have already received the 2.24 mL labeled products but can only bill one pen as 2.4 mL. What should pharmacies do if this happens? PAAS still recommends …
you verify how your software currently bills Forteo® and its generics. Make sure that when submitting a claim, the metric quantity aligns with what is displayed in your software system’s compendia and that the correct cost for one pen is included in your transmission. Once the compendia updates the metric quantity to 2.24 mL, ensure your drug file is updated to accurately reflect your cost for one pen accordingly.
PAAS Tips: