Are you compliant with USP 800? While USP 800 became official on December 1, 2019, it was informational only and not compendially applicable. With the recent updates to USP 795, Nonsterile Compounding and USP 797, Sterile Compounding in November 2022, USP 800 was effective as of November 1, 2023.
USP 800 is not just for compounding pharmacies as it defines the quality standards for the safe handling of hazardous drugs in all healthcare settings, with the goal to minimize exposure to healthcare personnel, the patients in your pharmacy, and to the environment.
You might still be asking, does my pharmacy need a USP 800 program?
The answer is yes! All healthcare settings, including community pharmacies, should now have a “handling of hazardous drugs” program in place and while, USP itself is not an auditing entity, there are other agencies that may audit including OSHA, EPA and most likely State Boards of Pharmacy, many of which have already committed to doing so. The safe handling of hazardous drugs is now considered a “standard of practice” so implementation is essential to protect the health and safety of your employees.
Are you struggling with the multitude of requirements?
This isn’t one of those “throw it together in an afternoon” type of programs. PAAS can help! PAAS’ customized USP 800 Compliance Program provides:
- A detailed Program Guide walking you through everything from the why to the how
- Annual web-based training to keep the team up to date including a quiz to assess competency
- A USP 800 Compliance Program Policy & Procedure manual tailored to the unique needs of your pharmacy with minimum interruption to workflow
- An easy-to-use Assessment of Risk (AoR) tool to help you create custom containment strategies for each drug and its unique dosage form.
Call (608) 873-1342 to sign up for PAAS’ USP 800 Compliance Program and you can immediately get started on setting up your program in hours, not days!
Albuterol HFA Inhaler Substitution Refresh
There have been many new albuterol HFA NDCs released since the June 2020 article, First AB-Rated Generic for Proventil® HFA Approved, and since albuterol inhaler substitutions require an extra level of consideration due to not all NDCs being equivalent, a refreshed chart was in order.
The chart below shows albuterol products grouped into their respective Therapeutic Equivalence (TE) Code category – AB1, AB2, or BX. As a reminder, substitution can occur at the pharmacy level if the substitution involves two therapeutically equivalent products and is allowed per state law.
Example: AB1 inhaler 6.7 gm Proventil® would be able to be substituted for AB1 inhaler 6.7 gm Sandoz albuterol HFA.
If a substitution to a non-equivalent is required, it would be necessary to contact the prescriber and make a corresponding clinical note documenting the conversation.
Example: Prescription written for AB1 inhaler 6.7 gm Proventil® but PBM rejects claim stating an AB2 inhaler such as 8.5 gm Lupin Pharmaceuticals albuterol HFA is required.
Refer to the article linked above for examples of how to handle substitutions based on how a prescription is written.
USP 800 – The Struggle is Real…
Are you compliant with USP 800? While USP 800 became official on December 1, 2019, it was informational only and not compendially applicable. With the recent updates to USP 795, Nonsterile Compounding and USP 797, Sterile Compounding in November 2022, USP 800 was effective as of November 1, 2023.
USP 800 is not just for compounding pharmacies as it defines the quality standards for the safe handling of hazardous drugs in all healthcare settings, with the goal to minimize exposure to healthcare personnel, the patients in your pharmacy, and to the environment.
You might still be asking, does my pharmacy need a USP 800 program?
The answer is yes! All healthcare settings, including community pharmacies, should now have a “handling of hazardous drugs” program in place and while, USP itself is not an auditing entity, there are other agencies that may audit including OSHA, EPA and most likely State Boards of Pharmacy, many of which have already committed to doing so. The safe handling of hazardous drugs is now considered a “standard of practice” so implementation is essential to protect the health and safety of your employees.
Are you struggling with the multitude of requirements?
This isn’t one of those “throw it together in an afternoon” type of programs. PAAS can help! PAAS’ customized USP 800 Compliance Program provides:
Call (608) 873-1342 to sign up for PAAS’ USP 800 Compliance Program and you can immediately get started on setting up your program in hours, not days!
Specialty Pharmacy Paying the Price: $20 Million Settlement for Kickbacks and Copay Waivers
A September 30, 2023, Department of Justice press release outlined a recent settlement between the U.S. government and a specialty pharmacy based in Delaware. The pharmacy agreed to pay a settlement of $20 million to resolve allegations that they violated the False Claims Act and the Anti-Kickback Statute by paying kickbacks to patients in the form of routinely waived copayments and to physicians in exchange for providing patient referrals.
The government alleged that from August 2015 through May 2020, the pharmacy routinely waived copays for Medicare and TRICARE patients, regardless of any financial hardship need, to induce them to fill prescriptions at the pharmacy. Additional allegations include kickbacks to prescribers such as gifts, dinners, and free administrative and clinical support services to induce patient referrals to the pharmacy. The prescribers involved knowingly solicited and accepted the remuneration and have settled separately.
Two former employees, who acted as whistleblowers under a qui tam lawsuit to report these abuses to the government, will receive over $4 million as part of the settlement.
Make sure your pharmacy staff has implemented a robust set of FWA policies and procedures, including discussion of Anti-Kickback Statute, and are completing annual training on healthcare fraud, waste, and abuse. Protect your pharmacy by enrolling in the PAAS National® FWA/HIPAA Compliance Program today. Call us at (608) 873-1342 to get started.
You’ve Got Mail! Post-COVID-19 Mailing & Delivery Considerations
After three years of a Public Health Emergency (PHE) due to COVID-19, the Department of Health and Human Services (HHS) allowed the PHE to expire May 11, 2023. With the end of the PHE came the end of most PBM concessions, including those made in relation to mailing and delivery of medications. Therefore, re-training staff on the importance of adhering to PBMs’ signature, mailing, and delivery requirements will help curtail audit risk.
The remainder of this article will focus on adherent mailing and delivery practices.
PBMs are more restrictive with allowing prescriptions to be mailed. Caremark will allow mailing for up to 20% of the monthly claims submitted under their “Retail Pharmacy” definition. Anecdotally, Express Scripts has some degree of tolerance for mailing; however, it varies by situation (e.g., distance, drugs being dispensed and frequency). Humana, who usually completely restricts mailing prescriptions, is allowing their PHE concession on mailing prescriptions to continue until January 1, 2024. Consider this during open enrollment or put a plan in place to set patient expectations come 2024, if necessary.
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3…2…1…The Countdown is On to Complete Annual Fraud, Waste & Abuse Training
It is that glorious time of year again! Time for staff to be occupied not only with the daily activities of billing and filling medications, but also occupied with cough/cold/flu season, vaccine administration, answering Medicare Part D open enrollment questions, and holiday closures. Now is the time to ensure staff complete their annual Fraud, Waste & Abuse and HIPAA Compliance training since the December 31st deadline will be here before we know it!
Employees who are involved with filling, billing, dispensing or delivery of Medicare and/or Medicaid prescriptions are required to be trained within 30 days of hire (per PBM requirements) and at least annually thereafter. Per CMS Chapter 9.50.3, training and education for employees does include the CEO and senior administrators or managers. Relief pharmacists, students, interns, job shadows, and delivery drivers also need training. The training must cover FWA and General Compliance topics and must include details outlining your pharmacy’s specific policies and procedures of how you prevent, detect, and correct FWA.
Current PAAS National® FWA/HIPAA Compliance Program members can meet annual training requirements through the PAAS Member Portal. A few important things to note:
If you are unsure of all the necessary requirements, contact PAAS at (608) 873-1342 today for more information on our comprehensive, and customized, FWA/HIPAA Compliance Program.
Fair Access for All: The Proposed Rule’s Potential to Strengthen Anti-Discrimination in Pharmacies
The Biden-Harris Administration is continuing to bolster the importance of equal access to health care and human services for individuals with disabilities through a new proposed rule. The Discrimination on the Basis of Disability in Programs or Activities rule will update and clarify the obligations stated in the original Section 504 of the Rehabilitation Act of 1973, enacted almost fifty years ago. Under Section 504, individuals with disabilities are afforded equal access to any federally funded program or activity and cannot be discriminated against due to their disability. Within the article released by the HHS Press Office on September 7, 2023, it states that the COVID-19 pandemic “shone a spotlight” on areas of discrimination, such as individuals being refused medical treatment due to their disability, inability to access medical equipment and websites, and being forced to receive treatments only in institutional settings. As a result, the Administration for Community Living along with the Office for Civil Rights suggested the following changes be made to the current implementation of Section 504:
It is becoming increasingly apparent that cultural competency and the ability to provide equivalent services across all patient populations is imperative. The first step to adhering to this new standard of care is ensuring staff has undergone Cultural Competency Training. Login to the PAAS Member Portal to view the on-demand webinar “Does My Pharmacy Really Need Cultural Competency Training?” for additional information.
Call PAAS National® (608) 873-1342 to add PAAS’ Cultural Competency Training to your membership.
Advances in Respiratory Syncytial Virus (RSV) Prevention
There are two RSV vaccines FDA-approved for people ages 60 years and older – AbrysvoTM and Arexvy®.
CDC recommends that adults ages 60 years and older may receive RSV vaccination, using shared clinical decision-making (SCDM). This means that health care providers (including pharmacists) should talk to these individuals about whether RSV vaccination is appropriate for them.
Because of the SCDM workflow, the immunization action coalition (immunize.org) has not created a standing order template or screening checklist.
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Biosimilar Advancements: Understanding the Latest Updates on Humira® with Cyltezo® and Abrilada™
At the time our April 2023 Newsline article Biosimilar Adoption for Humira® in 2023 was published, eight FDA biosimilars for Humira had been approved, and five more were pending approval. As of June, three additional biosimilars are in the market and three are still pending FDA approval. In October, Abrilada™ was granted FDA approval as an interchangeable biosimilar. Now, Abrilada™ along with Cyltezo® are the only two biosimilars that are interchangeable with Humira® without the intervention of the prescribing physician, depending on state pharmacy laws. The chart below
FDA Approved
Ingelheim
Pending Approval
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Audit Target: Linzess® Prescriptions
PAAS National® analysts have noticed an increase in audits targeting Linzess®. Linzess® is a focus of PBM audits not only because of the high cost, but also the manufacturer dispensing requirements. Not following FDA approved guidelines when dispensing this medication will likely result in full recoupment.
Allergan, the manufacturer of Linzess®, has not provided evidence to the FDA for the safety and efficacy of this medication outside the original container. PAAS has reached out to Allergan looking for additional stability information to appeal audit recoupments; however, they have only confirmed the current requirements. Pharmacies can visit DailyMed for medication information, including How Supplied/Storage and Handling requirements under Section 16 of the drug label information.
While Linzess® is not the only medication required to be dispensed in the original container, it is frequently prescribed for patients in long-term care and for those who have medications in compliance packaging. Unfortunately, there are no exceptions for these situations, and the original container must be given.
Billing Linzess® for quantities other than increments of 30 capsules will make the claim an easy audit target for any PBM to identify the medication was not dispensed in the original container. This is true for many other medications with specific dispensing requirements as well. PAAS has created our Dispense in Original Container Chart, based on the medications we frequently see audited. You can find this and many other Day Supply Charts and Proactive Tips available on the PAAS Member Portal.
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NEW PAAS Resource – Printable Signature Logbook
Many pharmacies have made the switch to electronic signature log capture, but paper signature logs have not gone away. Some pharmacies choose to maintain all signature logs through a paper log but those with an electronic signature capture system may still find themselves with the need for a paper signature log. Common reasons for paper logs include:
To aid our member pharmacies in having appropriate documentation on their paper signature logs, PAAS National® is now offering a free printable signature book. To access this new tool, log onto the PAAS Portal, visit the Forms tab then download and the 400+ page Signature Logbook. Send the pdf to your local print shop and have them create a bound book. The form includes a place to document the date filled, acceptance or refusal of a consultation, prescription number, third party program, date picked up, signature, and more!
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