Good news! The Public Readiness and Emergency Act (PREP Act) did not expire at the end of this year, according to a declaration published on December 11, 2024, by the U.S. Health and Human Services (HHS). The declaration has extended the authority for pharmacists, pharmacy interns and pharmacy technicians to administer vaccines and test patients for COVID-19 through December 31, 2029.
Per HHS Secretary Xavier Becerra, “COVID-19 continues to present a credible risk of a future public health emergency…Continued coverage under the PREP Act, as provided in this Declaration, is intended to prepare for and mitigate the credible risk presented by COVID-19. This includes extending the time period for PREP Act coverage for licensed pharmacists, pharmacy interns, and qualified technicians, which allows for continued access by the recipient Population to Covered Countermeasures that are COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests”.
Included in the amended Declaration, Secretary Becerra recognizes the impact that pharmacies have had in mitigating the effects of the PHE, asserting “As stated in prior amendments to this Declaration, licensed pharmacists, pharmacy interns and qualified pharmacy technicians are well positioned to provide continued access to Covered Countermeasures, particularly in certain areas or for certain populations that have too few primary-care providers or that are otherwise medically underserved. As of 2022, nearly 90 percent of Americans lived within five miles of a community pharmacy. During the COVID-19 pandemic, the majority of Americans have received their COVID-19 vaccines and tests from a pharmacy. In addition, continued access by the Population to seasonal influenza vaccines mitigates risks that seasonal influenza infections, in conjunction with COVID-19 infections, could overwhelm healthcare providers.”
For more details on the extension of the PREP Act, you can read the published declaration on the Federal Register. Due to this extension, the November 2024 Third Amendment to the PREP Act Expiring Soon! is now outdated.
PAAS Tips:
- Review our September 2024 Newsline Article, Flu Shot Season – Are You Prepared? for a recap on what documentation is needed for a successful audit on your vaccine prescriptions
Unique Eyedrop Calculation Challenges
Pharmacy social media platforms host passionate discussions on the correct way to bill days’ supply for eyedrops almost every week. Do you use 15 drops/mL, 20 drops/mL, or something else? As it turns out, the “right answer” depends on the PBM you are billing and if the eyedrop is a solution or a suspension. Sound complicated? PAAS National® has a one-page chart and an app for that!
To make matters worse, there are some unique situations where using the PBM guidance is not relevant.
For example, some manufacturers have specific guidance for drops/mL due to a viscosity and drop size difference (e.g., Miebo® [272 drops/3 mL], Vevye® [200 drops/2 mL], and Vyzulta® [81 drops/2.5 mL]), and you should calculate the days’ supply based on the manufacturers’ guidance.
Additionally, some eyedrops have a specific beyond use date in Section 16 Storage and Handling of the product labeling (e.g., AzaSite® [14 days], Rocklatan® [42 days], Rhopressa® [42 days], Vyzulta® [56 days], Xalatan® [42 days]) and cannot have a days’ supply greater than the beyond use date. Do not assume that all eyedrops have a beyond use date of 28 days. This is NOT true in most cases.
If a prescriber indicates that patient should discard the eyedrop after using it for ’X’ number of days, this must be explicitly spelled out in the directions to the patient. For example, eye drops that are to be used in the right eye for two weeks after surgery then discarded for a new bottle to be used for the left eye should clearly indicate this in the directions before billing a 14-day supply. If multiple package sizes of the product exist, use the smallest bottle closest to the treatment duration as possible. The PBM will not pay for a patient to discard the remainder of a 15 mL bottle when a 5 mL bottle would have sufficed.
PAAS Tips:
Best Practices for Out-of-Stock Medications
PAAS National® analysts continue to see pharmacies struggle with invoice audits, which are most frequently performed by Caremark® and OptumRx®.
Most PBMs perform invoice audits on an aggregated basis and total all claims billed to their particular PBM over an entire date range (e.g. 12 months). The totals of each NDC billed are then compared against the pharmacy’s purchases from authorized wholesalers over a similar period. If a pharmacy has an “inventory shortage”, it is commonly explained by a missing wholesaler purchase file, wrong NDC billed, purchases from an unauthorized wholesaler, or even product on the shelf prior to the date range.
Occasionally, pharmacies have shortages due to a claim being billed at the end of an audit date range for a medication that the pharmacy has not ordered/stocked before. If this out-of-stock claim falls inside the audit date range but the date of invoice falls outside (after) the date range, this can create a mathematical shortage. These situations are generally rare but can create issues for pharmacies undergoing an invoice audit.
Most PBMs have language that states the date of service must reflect the date the prescription is “prepared/readied for dispensing”, which they can argue isn’t possible without the drug on-hand. OptumRx, Horizon NJ Health, and NJ Medicaid take the language in their Provider Manuals (or Agreements) even further, indicating that pharmacies are required to have product in stock prior to even submitting a claim for the drug product. This requirement is highly impractical as pharmacies cannot afford to stock every medication that exists and do not know if a prescribed medication is even covered (or if patient even wants it) until after the claim is billed. Pharmacies should consider reversing claims for high cost, out-of-stock medications and rebilling them after the product has been ordered and is on-hand to reduce audit liability.
PAAS Tips:
If you’re not a member of PAAS’ FWA/HIPAA compliance program, contact us today at (608) 873-1342 or info@paasnational.com to add the program for a discounted rate.
Oral-Only ESRD Drugs Removed from Medicare Part D Coverage in 2025
Starting January 1, 2025, Medicare Part D no longer covers “oral-only” medications used for patients with end-stage renal disease (ESRD) undergoing dialysis treatment. This mainly impacts payment of phosphate binders such as PhosLo® (calcium acetate) and Renvela® (sevelamer carbonate), as well as Xphozah® (tenapor).
When used for ESRD patients, these oral-only medications will now be covered by Medicare Part B under the ESRD Prospective Payment System (PPS) bundled payment to dialysis facilities and should NOT be billed by pharmacies to a Medicare patient’s Part D plan (pharmacies will also not be able to bill Medicare B). If pharmacies are looking to continuing dispensing these medications, advanced coordination with dialysis facilities will be required to ensure pharmacies receive reimbursement.
Part D claims may reject with the following NCPDP reject codes:
If Part D claims do not reject and pharmacy bills Part D incorrectly, then there will likely be future coordination of benefit (COB) “audits” where the Part D plan recoups the pharmacy payment, leaving the pharmacy to reconcile with the dialysis facility after the fact. PAAS National® already sees these types of retroactive, COB audits when claims were billed to Part D but “should have” been billed to Part A for patients residing in a nursing home on a covered stay.
Phosphate binders remain coverable under Part D for other medically accepted indications for patients not on dialysis for ESRD. Pharmacies may want to obtain (and document) diagnosis codes to support these claims.
Numerous organizations, including NCPA, the American Society of Consultant Pharmacists (ASCP), and the American Society of Nephrology (ASN) provided feedback to CMS that this change in payment policy will negatively affect patients as many dialysis facilities do not have an in-house pharmacy and may supply these medications without the expertise of a pharmacist.
PAAS Tips:
The HIPAA Hot Seat: What You Need to Know About the “2024 Privacy Rule” and Reproductive Health Care
The 2022 Dobbs v. Jackson Women’s Health Organization ruling, which overturned Roe V. Wade, prompted modifications to the Privacy Rule (45 CFR Parts 160 and 164). The Biden-Harris administration, partially through President Biden’s Executive Order (EO) 14076, aimed to better protect information related to reproductive health care, to bolster patient-provider confidentiality, and promote trust between patients and their health care providers. Subsequent to EO 14076, the HIPAA Privacy Rule was updated to limit the circumstances in which the use or disclosure of PHI related to reproductive health care is permitted. The final rule (“2024 Privacy Rule”) became effective June 25, 2024, with compliance enforcement effective December 23, 2024; except for the requirement to update the covered entity’s Notice of Privacy Practices which is delayed until February 16, 2026.
The 2024 Privacy Rule strengthens privacy protections by prohibiting the use or disclosure of PHI by a covered entity (e.g., pharmacy), or business associate, for either of the following activities:
Under this rule, the prohibition applies where a covered entity or business associate has reasonably determined that one or more of the conditions exists:
The Final Rule includes a presumption that the reproductive health care provided by a person other than the covered entity (e.g., pharmacy), or business associate, receiving the request was lawful. In such cases, the reproductive health care is presumed to be lawful under the circumstances in which it was provided unless one of the following conditions are met:
To implement the prohibition, the Final Rule requires a covered entity (e.g., pharmacy), or business associate, when it receives a request for PHI potentially related to reproductive health care, to obtain a signed attestation that the use or disclosure is not for a prohibited purpose. This attestation requirement applies when the request is for PHI for any of the following:
The requirement to obtain a signed attestation gives a covered entity (e.g., pharmacy), or business associate, a way of obtaining written representations from persons requesting PHI that their requests are not for a prohibited purpose. Additionally, the attestation includes language that federal law prohibits any individual from improperly obtaining PHI and that knowingly, and in violation of HIPAA, obtaining PHI under false pretenses or disclosing the PHI to another person can result in criminal penalties. A covered entity receiving a PHI request related to reproductive health care should evaluate the request and all available data and circumstances surrounding the request to make a reasonable determination to substantiate the validity of the request.
PAAS Tips:
If you’re not a member of PAAS’ FWA/HIPAA compliance program, contact us today at (608) 873-1342 or info@paasnational.com to add the program for a discounted rate.
2024-2025 Self-Audit Series #12: Electronic Prescriptions
This month’s article will wrap up the 2024-2025 Self-Audit Series. Our focus for this article is electronic prescriptions and their potential audit risks. Electronic prescriptions have solved some problems (e.g., indecipherable handwriting), but have also created new problems. By focusing on the following tips when reviewing your electronic prescriptions, you can help prevent significant recoupments.
Be sure any clarifications are clearly documented with these four elements: date, name and title of who you spoke with, what was clarified, initials of who made the call. This information must be accessible to the auditor upon audit.
PAAS Tips:
Caremark Bulk Purchase Notification
Did you make any “bulk purchases” of inventory in December 2024? If so, then you must act now to protect against a Caremark invoice audit that could happen in 2026!
Remember that a future invoice audit from Caremark could cover purchases made between 02/01/2025 – 01/31/2026 which means that any purchases made during December 2024 will NOT be credited unless you provide notification to Caremark within 21 days after the purchase.
Section 8.05 of the Caremark Provider Manual outlines the requirement to provide notification of these bulk purchases for audit purposes – you must notify Caremark via mail or email as outlined below:
Email: PharmacyAudit@CVSHealth.com
Mail:
CVS Caremark
Attn: Bulk Purchase Notification, MC 020
9501 E. Shea Boulevard
Scottsdale, AZ 85260
Pharmacies do not need to include cost information when submitting. Some pharmacies have received a notification back stating that their purchase was “routine in nature” and would not be considered a bulk purchase, but PAAS would encourage pharmacies to continually inundated/notify Caremark and document these responses as they could become relevant (and useful) in an audit situation.
PAAS Tips:
PREP Act Extended Through 2029!
Good news! The Public Readiness and Emergency Act (PREP Act) did not expire at the end of this year, according to a declaration published on December 11, 2024, by the U.S. Health and Human Services (HHS). The declaration has extended the authority for pharmacists, pharmacy interns and pharmacy technicians to administer vaccines and test patients for COVID-19 through December 31, 2029.
Per HHS Secretary Xavier Becerra, “COVID-19 continues to present a credible risk of a future public health emergency…Continued coverage under the PREP Act, as provided in this Declaration, is intended to prepare for and mitigate the credible risk presented by COVID-19. This includes extending the time period for PREP Act coverage for licensed pharmacists, pharmacy interns, and qualified technicians, which allows for continued access by the recipient Population to Covered Countermeasures that are COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests”.
Included in the amended Declaration, Secretary Becerra recognizes the impact that pharmacies have had in mitigating the effects of the PHE, asserting “As stated in prior amendments to this Declaration, licensed pharmacists, pharmacy interns and qualified pharmacy technicians are well positioned to provide continued access to Covered Countermeasures, particularly in certain areas or for certain populations that have too few primary-care providers or that are otherwise medically underserved. As of 2022, nearly 90 percent of Americans lived within five miles of a community pharmacy. During the COVID-19 pandemic, the majority of Americans have received their COVID-19 vaccines and tests from a pharmacy. In addition, continued access by the Population to seasonal influenza vaccines mitigates risks that seasonal influenza infections, in conjunction with COVID-19 infections, could overwhelm healthcare providers.”
For more details on the extension of the PREP Act, you can read the published declaration on the Federal Register. Due to this extension, the November 2024 Third Amendment to the PREP Act Expiring Soon! is now outdated.
PAAS Tips:
Are You Willing to Risk Recoupment for Missing DUR and SCC Documentation?
Pharmacies often work in a fast-paced environment with an increasing workload as we see stores closing, more transfer-ins, and higher patient demand. This results in an increased urgency to perform data entry faster, which can lead to the use of override codes to get the claim adjudicated quickly. PAAS National® is here to remind pharmacies to proceed with caution when handling clinical drug utilization reviews (DURs) and submission clarification codes (SCCs). Lack of proper documentation supporting the use of DURs and SCCs can result in audit recoupments.
DUR messages are designed as a warning to avert potential patient harm and require pharmacist intervention before proceeding. These are the more obvious DURs to spot and handle. Soft DURs can be easily overlooked but still require thorough review. For example, a DUR indicating the prescription was filled at another pharmacy should generate questions regarding current therapy or possible duplicate therapies the patient may be unaware of.
SCCs might be necessary to use when a patient is requesting a refill due to an upcoming vacation, lost or stolen medication, or a change in therapy. Some PBMs are known for auditing high dollar claims with override codes, like Express Scripts and Prime Therapeutics. Auditors are looking for documentation, including rationale on the prescription, when the override codes are used, but what does this mean? Below is an example of appropriate DUR and SCC documentation.
DUR Documentation: HD/M0/1B – Verified with Dr. Jones they are aware this is a high dose/Told to fill prescription as is/Pharmacist’s initials/date
SCC Documentation: SCC 03 – Susan is going on vacation to Italy from 01/06/2025 to 01/20/2025 & requires a vacation supply of medicine/date
Simply documenting the override codes utilized does not provide the auditor with the explanation of why it was appropriate to use. When under audit, be sure to make all clinical notes visible for the auditor. Rescan hard copies into your pharmacy software system when handwriting notes if necessary; this can help ensure the notes will not be missed when under audit.
PAAS Tips:
Vaginal Creams: Why 30 Days’ Supply Is Probably Not Appropriate
Topical medications like creams and ointments are always a target for PBMs to audit, but lurking in those topicals is a bullseye that PBMs are always aiming for – vaginal creams. Estrace® and Premarin® are easy targets due to the variety of discrepancies that could be found when auditing.
The most common error PAAS National® Analysts come across when reviewing vaginal cream prescriptions is …
related to days’ supply issues. Do the directions on the hard copy give a calculable day supply? Are there grams per application? If not, the pharmacy should clarify with the prescriber prior to dispensing and put a clinical note on the hard copy. Directions like “one application twice weekly” or “use as directed, a pea-sized amount” would also not suffice for calculable directions, as they are not specific enough, and most PBMs will not assume “pea-sized” amount is 0.25 g. PAAS recommends communicating with the provider to clarify and adding a clinical note to the hard copy. Be sure that these clarifications (frequency and/or volume) are also reflected on an updated patient label prior to dispensing.
Once you determine the prescription contains calculable directions, the next step would be to bill the accurate day supply. Pharmacies can fall into the trap of assuming a days’ supply exceeding 90 days will surely be rejected based on historical experience; therefore, a 90 days’ supply is billed to the insurance. This places the pharmacy at risk for an invalid day supply discrepancy, as well as potential refilled too soon discrepancies on subsequent refills. Unbeknownst to many pharmacies, PBMs have begun to allow accurate [>90] days’ supplies to be billed for certain types of medications, including vaginal creams. Our recommendation is to always submit a claim with the true and accurate days’ supply first. If the plan rejects the days’ supply, PAAS recommends contacting the insurance help desk for an override. If the insurance does not have an override for the day supply, document this on the hard copy and bill for the maximum day supply allowed by insurance. To prevent accidental early refills, PAAS recommends adding a note on the pharmacy label in the directions, making both staff and patients aware of the actual day supply. The more visibility the note is, the less likely an early refill will be missed.
PAAS Tips:
PBM Prescription Validation Requests – What Are They Looking At Now?
The July 2024 PAAS National® Newsline article, What’s New with Prescription Validation Requests in 2024? compared the top five drugs targeted in the first six months of 2024. The chart below shows the top drugs picked for claim reviews in the second half of 2024, and a recap of the first half of 2024.
As you can see (and probably not a surprise), Ozempic® is the top drug reviewed through all of 2024. Additionally, you can see how the PBMs shift their focus on which drugs they select to perform claim reviews on.
The top 5 comments noted by an analyst after claim review for the second half of 2024 are the same 5 from 2023:
PAAS Tips: