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 is now outdated.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
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.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
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 …
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
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.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
2025 PAAS Fraud, Waste & Abuse and HIPAA Compliance Program Updates
PAAS National®® continuously monitors legislative and regulatory changes that may impact your Fraud, Waste & Abuse and HIPAA Compliance Program. We keep a close eye on enforcement from the Department of Justice, Office of Inspector General, State Attorney Generals, and Office for Civil Rights to help ensure the program meets interpretative standards. Furthermore, PAAS works to keep pace with Pharmacy Benefit Managers as they continue to add credentialing requirements that can be extremely difficult, and a significant nuisance, to independent pharmacies.
PAAS has implemented changes to ensure pharmacies continue to have a robust program in place. PAAS FWA/HIPAA compliance program members can login to the member portal to view the 2025 FWAC and HIPAA Updates. This year’s updates included a procedure for CMS-10882 (Medicare Prescription Payment Plan), PHI safeguard considerations for Remote/Hybrid work, enhancements to the required HIPAA Security Risk Analysis, Pharmacy-to-Pharmacy Inventory Transfer Log, and a policy and procedure related to the 2024 Privacy Rule (request to access or release PHI potentially related to reproductive health).
Administrators should review all Compliance tasks (located in the left-hand navigation on the PAAS Member Portal) at least annually to keep the program up-to-date and in compliance. Section 2.6 Updates of Policies and Procedures of your manual contains information on maintaining open lines of communication and the distribution of changes.
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.
Billing Ozempic® 0.25 mg Weekly as Maintenance – What PBMs Say
PAAS National® continues to see GLP-1 medications as a high audit target. Recall the FDA-approved initial dosing for Ozempic® is 0.25 mg injected subcutaneously once weekly for four weeks, followed by 0.5 mg once weekly (see section 2.2 of product labeling). However, pharmacies often see prescribers write for Ozempic® 0.25 mg weekly dose as maintenance. While …
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Compound Supplier Medisca Pays $21.75 Million Over Inflated AWPs
The Department of Justice recently announced that Medisca Inc. will pay $21.75 million to settle allegations of fraud involving inflated Average Wholesale Prices (AWPs) for two ingredients used in compound prescriptions – resveratrol and mometasone furoate. The government alleges that the scheme caused pharmacies to submit false claims to federal healthcare programs, including TRICARE and the Department of Labor’s Office of Workers’ Compensation Programs.
Medisca reported highly inflated AWPs to price listing agencies, increasing reimbursements for its customers and creating massive profit spreads. For example:
These inflated prices incentivized pharmacies to use Medisca’s ingredients, over competitor products, leading to fraudulent billing that overcharged federal programs by thousands per prescription.
The case was brought under the False Claims Act (FCA) by a qui tam relator (a Texas pharmacist) who will receive $3.4 million of the settlement. The settlement underscores the government’s commitment to combating healthcare fraud and protecting taxpayer funds.
The investigation involved collaboration between the Justice Department’s Civil Division, U.S. Attorneys’ Offices in Texas, and federal investigative agencies such as the Defense Criminal Investigative Service (DCIS) and U.S. Postal Service Office of Inspector General.
The government filed similar complaints against other compound ingredient suppliers in 2019 and 2021.
PAAS Tips:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Optimizing Prescriber Statements: Best Practices and Tips
Prescriber statements have become one of the most valuable tools a pharmacy can use when needing to appeal claims found to be discrepant for a variety of reasons. They commonly take the form of a letter written by the prescriber to the PBM confirming, clarifying, or validating a prescription filled by your pharmacy. While every PBM has their own requirements, PAAS National® analysts have compiled a list of the typically required elements below.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
CMS Updates HIV PrEP Supply Fee Code, Effective 01/01/2025
In December 2024, PAAS National® brought you the Medicare Part B Coverage of HIV PrEP Newsline article which provided an in-depth look into appropriately billing HIV PrEP medications to Medicare Part B. The original shift from billing these medications from Medicare Part D to Part B was effective just a few months ago (September 30, 2024, to be precise), and CMS has already instituted a change to the supply fee HCPCS billing code.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
2024-2025 Self-Audit Series #11: Controlled Substance Prescriptions
The opioid epidemic continues to make controlled substance prescriptions an increased focus for PBM audits. The potential for fraud, diversion, overdoses, and abuse remains high and pharmacies must stay vigilant when dispensing these prescriptions.
Due to federal and state requirements, controlled substance prescriptions have an increased risk of audit discrepancies. When found discrepant, PBMs typically cite as “law violations”, which are very difficult to overturn on audit appeal. Taking time to look over controlled prescriptions closely could prevent audit recoupment. Be sure to share the following tips with your pharmacy staff:
PAAS Tips:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips: