Compliance

2026 ACA Annual Conference & Expo: Pharmacy Education, Innovation & Growth in New Orleans

2026-08-26T11:09:49-05:00August 26th, 2026|Categories: Continuing Education, AI+technologies, Business, Community Pharmacy, Compliance, compounding, Hormones, networking, Pharmacy Law, Pharmacy Practice, Professional Development, Professional Growth, Regulatory Issues|Tags: , , , , , , , , , , , , , , , , , |

New Orleans is calling! Join pharmacy professionals from across the country for the 2026 American College of Apothecaries Annual Conference & Expo, September 24–26, 2026, at the Royal Sonesta New Orleans.

This year’s conference brings together 10 contact hours (1.0 CEU) of continuing education, timely pharmacy topics, practical strategies, industry resources, and valuable opportunities to connect with colleagues and exhibitors—all in the heart of New Orleans.

Whether you’re focused on strengthening patient care, navigating today’s regulatory environment, expanding your compounding knowledge, or finding new ways to grow your pharmacy, the 2026 ACA Annual Conference & Expo offers education and ideas you can take back to your practice.

Education for Today’s Pharmacy Practice

Hear from experienced pharmacy professionals and industry experts on topics affecting pharmacy practice today, including:

  • FDA guidance and compounding compliance
  • Sterile and nonsterile compounding facility design
  • Peptides and the evolving compounding landscape
  • Hormone health and progesterone therapy
  • Drug-induced nutrient depletion
  • Federal and state pharmacy law and regulatory updates
  • Pharmacy financing and acquisitions
  • Social media strategies for independent pharmacies
  • Artificial intelligence and ethical pharmacy practice

The program combines clinical education, regulatory and compliance updates, compounding, technology, and business development, giving attendees the opportunity to explore multiple areas of pharmacy practice in one conference.

More Than Continuing Education

The ACA Annual Conference & Expo is also an opportunity to step away from the day-to-day routine, exchange ideas with other pharmacy professionals, build new relationships, and discover products, services, and resources that can support your practice.

Spend time with pharmacists, pharmacy owners, pharmacy technicians, compounding professionals, exhibitors, and other healthcare professionals who understand the opportunities and challenges facing pharmacy today.

Your Conference Registration Includes

  • 10 contact hours (1.0 CEU) of continuing education for eligible attendees
  • Thursday evening Cocktail Reception
  • Welcome Dinner, Board Installation & Fellow Induction
  • Conference meals
  • Exhibitor experiences and access to participating exhibitors
  • Networking opportunities throughout the conference

Stay at the Royal Sonesta New Orleans

Make the most of your conference experience by staying where the action is! The Royal Sonesta New Orleans, host hotel for the 2026 ACA Annual Conference & Expo, places attendees in the heart of New Orleans’ historic French Quarter.

Located on Bourbon Street, the Royal Sonesta offers convenient access to conference activities while putting you within walking distance of the dining, music, culture, and attractions that make New Orleans such a memorable destination.

ROYAL SONESTA NEW ORLEANS
300 Bourbon Street
New Orleans, LA 70130

Hotel Reservations

The official ACA room block deadline has passed. However, attendees who still need hotel accommodations are encouraged to contact Susan Decker, ACA Director of Conferences, to inquire about current room availability and whether the ACA conference rate may still be available.

Susan Decker, ACA Director of Conferences
Phone: 434-989-5938
Email: susan@acainfo.org

Hotel availability and rates are not guaranteed and are subject to availability at the time of booking.

Planning to attend? We encourage you to make your hotel arrangements as soon as possible.

Meet Us in New Orleans

Set in the French Quarter at the Royal Sonesta New Orleans, this year’s conference gives you the opportunity to invest in your professional development while connecting with the pharmacy community in one of the country’s most distinctive destinations.

Come ready to learn, connect, exchange ideas, and discover new opportunities for your pharmacy and your career.

September 24–26, 2026
Royal Sonesta New Orleans
300 Bourbon Street | New Orleans, Louisiana

 

The 2026 ACA Annual Conference & Expo offers a total of 10 contact hours (1.0 CEU) of continuing pharmacy education for pharmacists and pharmacy technicians. See the individual activity information for specific ACPE Universal Activity Numbers (UANs), learning objectives, and credit hours. To receive ACPE credit, attendees must provide their NABP e-Profile ID and date of birth (MMDD) and complete the required activity evaluation. Continuing education credit will be submitted to CPE Monitor® following completion of all applicable requirements. Participants are encouraged to claim their credit promptly following the conference. Any unclaimed credit with a date of participation six months or older will not be eligible for processing. The American College of Apothecaries, Inc. is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Sessions carrying an ACPE Universal Activity Number are eligible for continuing pharmacy education credit as specified for each activity.

2026 Sponsors and Exhibitors

Compounding SIG Meeting: USP <795> & <800>: Powder Containment Solutions with AirClean Systems

2026-04-27T12:10:57-05:00April 27th, 2026|Categories: compounding, Community Pharmacy, Compliance, Pharmacy Practice, Public/Community Health, Quality Assurance, USP 795, USP 800|Tags: , , , , , |

Title: USP <795> & <800>: Powder Containment Solutions with AirClean Systems

Host:  Joah Sundrani
Panelists: Alanna Zow, M.S. Med. Sci., Technical Sales Specialist

Description: Learn about key USP <795> and <800> requirements for powder handling and containment. Alanna will highlight best practices for maintaining compliance, product integrity, and personnel safety, along with recommended solutions from AirClean Systems to minimize exposure and support efficient workflows.

This meeting will not offer CE. This meeting will be recorded.

This meeting is open to all Pharmacy Professionals, FREE for ACA Members, $10 for non-members, registration is required.

In addition, members of the Compounding SIG (Formerly Faculty) will have exclusive access to an online community.

Our Speaker:

Alanna Zow, M.S. Med. Sci., is a Technical Sales Specialist with AirClean Systems. She partners with customers across a diverse range of industries—including research, education, manufacturing, pharmaceuticals, and medical fields—to identify and deliver fume hood and enclosure solutions that support both process integrity and personnel safety.

Alanna holds a Bachelor of Science in Cell and Molecular Biology from the University of South Florida and a Master of Science in Medical Sciences from the University of Kentucky. Her academic background, combined with her technical expertise, enables her to effectively assess customer applications, understand key challenges, and recommend tailored solutions that align with their operational and safety requirements.

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GLP-1 & Peptide Compounding CE: Legal and Regulatory Insights for Pharmacy Professionals

2026-03-20T09:44:50-05:00February 24th, 2026|Categories: Continuing Education, Compliance, compounding, On-Demand Webinars, Pharmacy Law, Regulatory Issues, Telemedicine / Telepharmacy|Tags: , , , , , , , , , , , , , |

Missed the live webinar on March 18, 2026? It’s now available on-demand so you can access the full program whenever it fits your schedule.

Earn 1.0 hour (0.1 CEU) of continuing education credit with this on-demand webinar focused on the evolving legal and regulatory landscape surrounding compounded GLP-1s and peptides.

This program reviews key considerations for 503A pharmacies, 503B outsourcing facilities, and telehealth providers, including FDA and State Board of Pharmacy enforcement, private litigation trends, and the impact of the GLP-1 shortage ending.

Participants will gain a clearer understanding of current prescribing, compounding, and promotional practices, along with practical steps to reduce regulatory risk and maintain compliance in a rapidly changing environment.

 

Q: Who should attend this webinar?
Pharmacists and pharmacy technicians involved in compounding, compliance, or telehealth services, as well as healthcare professionals interested in GLP-1 and peptide therapies.

Q: Will I earn CE credit?
Yes. This activity provides ACPE-accredited continuing education for pharmacists and pharmacy technicians.

Stay informed on FDA enforcement, private litigation, and telehealth risks impacting compounded GLP-1s and peptides.

REGISTER HERE!

Note: It is not necessary to create a Lecture Panda account to register for this webinar.


The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 1 contact hour (0.1 CEU) of continuing education credit for pharmacists and pharmacy technicians.

Hazardous Drug Handling Continuing Education for Pharmacy Personnel | 6-Hour PTCB-Recognized CE

2026-03-19T14:15:55-05:00February 20th, 2026|Categories: Continuing Education, Compliance, Hazardous drug handling, Home Study, Patient Safety, Pharmaceutical Training, Pharmacy Practice, Regulatory Issues, USP 800|Tags: , , , , , , , , , , , , , , , , |

Hazardous Drug Handling – Primer for Pharmacy Personnel is a 6-hour (0.6 CEUs) knowledge-based home study designed for pharmacists and pharmacy technicians who handle hazardous drugs in any practice setting.

This program reviews key requirements under USP <800>, including engineering controls, negative pressure rooms, PPE, cleaning and decontamination procedures, hazardous drug dispensing, receiving and transport, disposal requirements, medical surveillance, and wipe sampling. Participants will also review the NIOSH list and understand how to assess risk and develop compliant SOPs within their facility.

The course emphasizes practical steps to reduce occupational exposure and strengthen documentation and training practices.

This home study is PTCB-Recognized as an Education/Training Program and may help pharmacy technicians prepare for the CPhT-Adv Advanced Certification in Hazardous Drug Management.

Strengthen hazardous drug handling practices and reinforce USP <800> compliance through structured training designed to protect both patients and pharmacy personnel.

What participants said:

  • “informative, concise, and easy to comprehend.”
  • “I can take and apply this knowledge in my current pharmacy.”
  • “It was very organized and easy to follow.”

Registration is below

Note: It is not necessary to create a Lecture Panda account to register for this home study.

The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 6 contact hours (0.6 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

Canadian Non-Sterile Compounding Standards: Continuing Education for Pharmacy Professionals

2026-08-21T10:45:18-05:00February 10th, 2026|Categories: Compliance, compounding, compounding training, Continuing Education, Documentation, Home Study, Pharmaceutical Training, Pharmacy Practice, Policies & Procedures, Quality Assurance, Regulatory Issues, Risk Management, SOPs|Tags: , , , , , , , |

This 6.0-hour (0.6 CEUs) knowledge-based home study is designed for pharmacists and pharmacy technicians involved in non-sterile compounding who want a clear understanding of Canadian regulatory standards and how they apply to day-to-day practice. The course focuses on reviewing current standards and best practices used to evaluate compounding procedures, develop pharmacy protocols, and apply appropriate quality controls to support the safety and effectiveness of non-sterile preparations for both patients and staff.


Documents Covered

  • Guidance on Pharmacy Compounding of Non-Sterile Preparations

  • Model Standards for Pharmacy Compounding of Non-Sterile Preparations

  • Printable and fillable forms to support documentation and recordkeeping


Topics Covered

  • Canadian regulatory guidelines and non-sterile compounding standards

  • Identifying risks and gaps in current compounding practices

  • Requirements for different levels of non-sterile compounding

  • Facility, equipment, and documentation expectations

  • Product and preparation requirements

  • Additional considerations for Level C non-sterile compounding


Who This Home Study Is For

  • Pharmacists involved in non-sterile compounding

  • Pharmacy technicians supporting compounding activities

  • Pharmacy professionals looking for a clearer understanding of Canadian non-sterile compounding standards

Review Canadian non-sterile compounding standards and understand how regulatory expectations apply to everyday pharmacy practice. 

What participants said:

  • “This course provided a very thorough and succinct explanation of all relevant information needed to safely implement compounding into the pharmacy workflow.”
  • “The instructor very clearly explained these concepts in a well-organized manner for the audience to comprehend.”
  • “The session provided a clear overview of current guidelines, easy access to commonly used compounding resources, and practical checklists that support safe compounding practices.”

Registration is below

Note: It is not necessary to create a Lecture Panda account to register for this home study.

Important note for Canadian participants:
Participants who are not receiving ACPE credit, including Canadian learners whose provincial regulatory bodies may not accept ACPE-accredited activities, will receive a Certificate of Completion upon successful completion of the post-test and evaluation. Certificates may be downloaded for personal records. Canadian pharmacists and pharmacy technicians are encouraged to confirm with their provincial college whether ACPE-accredited activities or certificates of completion meet their continuing competency requirements.


The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 6 contact hours (0.6 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

Optimize Sterile Compounding: An ACPE-Accredited 4-Hour Virtual Course

2026-04-16T10:17:06-05:00January 5th, 2026|Categories: Compliance, Continuing Education, FDA, Pharmaceutical Training, Pharmacy Practice, Regulatory Issues, Sterile Compounding, USP 797|Tags: , , , , , , , , , , , , , , |

This 4-hour accredited virtual CE course provides pharmacists and pharmacy technicians with essential knowledge related to aseptic processing and FDA compliance in sterile compounding.

Sterile compounding requires accuracy, consistency, and an understanding of current regulatory expectations. This course reviews key principles and requirements to help participants strengthen their foundational knowledge and stay current with evolving standards.

What You’ll Learn:
By the end of this engaging course, participants will be able to:

1️⃣ Describe aseptic processing and terminal sterilization methods
2️⃣ Explain release testing requirements, including visual inspection, sterility, and endotoxin testing
3️⃣ Identify and interpret key FDA guidance documents related to sterile compounding
4️⃣ Recognize appropriate component selection for compounded preparations
5️⃣ Understand the role of certificates of analysis and perform related calculations

Who Should Attend?
Perfect for pharmacists, pharmacy technicians, and healthcare professionals involved in sterile compounding.

Strengthen sterile compounding practices and reinforce regulatory readiness through focused, practical training designed for pharmacy professionals.

Optimizing Sterile Compounding: From Aseptic Processing to FDA Compliance

Date Selection For 2026

  • This course is delivered in a live virtual classroom format.
    Maximum Class Capacity: 12 participants


The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 4 contact hours (0.4 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

2025 American College of Apothecaries Conference & Expo

2025-10-31T02:13:11-05:00April 28th, 2025|Categories: Continuing Education, ACA Fellows Benefit, Administration/Management, Community Pharmacy, Compliance, compounding, DEA, Ethics, FDA, Fellows and Members, Fellows Benefit, Member Benefits, networking, News Release, Pain Management, Patient Care, Patient Safety, Personal Development, Pharmacists, Pharmacy Law, Pharmacy Practice, Pharmacy Technicians, Preceptor/Mentor Training, Professional Development, Professional Growth, Public/Community Health, Regulatory Issues, Revenue, Risk Management, Sports Medicine, Telemedicine / Telepharmacy, USP 795, USP 797, USP 800, Veterinary Compounding, Webinar|Tags: , , , , , , |

It’s time to pack your bags and polish your business cards — the 2025 ACA Annual Conference & Expo is where independent pharmacy meets unforgettable opportunity!

📍 Memphis, TN | September 25–27, 2025

Join us at the legendary Peabody Hotel for the 2025 ACA Annual Conference & Expo — where independent pharmacy professionals come together to connect, learn, and grow.

Your registration includes:
• Continuing Education credit (except guest registration)
• Thursday Night Welcome Reception & Dinner
• All conference meals

• Full access to the exhibition hall

This is your chance to network with pharmacy leaders, discover the latest trends, and showcase your brand in a dynamic, in-person setting. With educational sessions, social events, and all meals included, this is more than a conference — it’s where pharmacy takes care of business!

Speakers Include:

Philip Cowley, PharmD
Kathy Campbell, PharmD
Jessica Beal, PharmD
Jennifer Adams, PharmD, EdD, FAPhA, FNAP
Sue Paul, RPh
L. Michelle Woosley, PharmD, MBA, CMAP

Reserve your spot today and be part of something meaningful!

2025 ACE Save The Date Rectangle
Reservations
The Peabody Memphis – The “South’s Grand Hotel”

The Peabody Memphis is legendary for its charm, elegance, gracious hospitality, and rich history. This Memphis icon, opened in 1869, is listed on the National Register of Historic Places and is world-famous for its five resident Mallard ducks, who march daily through the lobby at 11am and 5pm.

Nestled in the heart of downtown, this AAA Four-Diamond hotel offers a one-of-a-kind experience just blocks from Beale Street, the Memphis Rock ‘n Soul Museum, Fed-Ex Forum, Sun Studio, and the Orpheum Theatre.  The Peabody Memphis offers two Restaurants, two Bars, Spa, and a Deli with ice cream and desserts.

THE PEABODY MEMPHIS
149 Union Avenue, Memphis TN 38103

Group Rate: $249 plus taxes and fees
Room Block Deadline: Monday, August 25, 2025, at 5:00 pm CDT

To make your reservations, click the button below or contact Susan Decker, ACA Director of Conferences at 434-989-5938 or susan@acainfo.org.

Individuals will guarantee reservations with a credit card or deposit equal to the first night’s room and tax.

2025 Sponsors and Exhibitors

AirClean
Boiron
Gates
RX Insider
Topi CLICK
ZRT Lab

DSCSA Compliance and Supply Chain Security Continuing Education

2026-06-02T09:48:13-05:00January 22nd, 2025|Categories: Continuing Education, Compliance, FDA, On-Demand Webinars, Pharmacy Law, Professional Development, Supply Chain Management|Tags: , , , , , |

📢 Missed the Webinar? Catch it On-Demand!

Webinar Title: DSCSA – 13 Year Implementation & 2024 Update
Accreditation: 1-hour CE (0.1 CEUs) for Pharmacists & Pharmacy Technicians

The DSCSA, enacted in 2013, is nearing full implementation! This on-demand webinar covers:

✅ Key DSCSA requirements for transaction information (TI) and transaction statements (TS)
✅ Steps to implement electronic traceability at the package level
✅ Strategies to ensure compliance with regulatory audits and inspections
✅ Best practices for identifying and reporting suspect products

FDA Enforcement Deadline: November 27, 2026 – Don’t wait to start preparing!

DSCSA 13 Year Implementation & 2024 Update — Webinar Graphic

Learn how to meet these requirements and stay ahead of PBM audits. Watch now and ensure your pharmacy is ready for the future of supply chain compliance.  

Speaker:

Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt’s Life Sciences Department. She is also a registered patent attorney and leads the firm’s Intellectual property team. She has broad and in-depth healthcare and regulatory experience. Her practice focuses on intellectual property (patents, trademarks, copyrights, trade secrets) and healthcare law, Food, Drug, Device & Cosmetic law (all facets-483s to clinical trials to registrations and product approval), pharmacy law and regulatory issues, 503A/503B compounding, Board of Pharmacy (licensing and disciplinary matters), PBM audits, and DSCSA supply chain compliance. Dr. Rumore has over 25 years of health-system, pharmaceutical industry, and law firm experience in the area of Food, Drug & Cosmetic Law, and pharmaceutical intellectual property Dr. Rumore is fluent in cGMPs, GCPs, writing and reviewing Clinical Trial Agreements (CTAs), Investigator brochures, manuscripts, labeling & advertising review, NDAs, study reports, and documents for regulatory submissions. She often prepares legal memoranda on healthcare/FDA matters and conducts Mock State Board of Pharmacy and FDA inspections for compounding pharmacies. Dr. Rumore has practiced both pharmacy and law. She has actual experience as a compounding pharmacist. She regularly counsels on Section 503A and state-specific compounding requirements, assesses compounding practices for state and federal regulatory compliance, including USP 797/795/800, medical necessity documentation, advertising & promotion, reimbursement issues, infrastructure, and preparing compounding policies and procedures that provide clear guidelines, standards, and training for staff.  Previously, she was at the Director level in  Drug Regulatory Affairs/Compliance in the pharmaceutical industry and hospital pharmacy. She taught Pharmacy Law, Drug Regulatory Affairs, and Food Drug & Cosmetic Law at several New York Colleges of Pharmacy and currently teaches Food, Drug & Cosmetic Law at Maurice A. Deane School of Law at Hofstra University. She is a frequent lecturer and has over 200 publications and presentations.


The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 1.0 contact hour (0.1 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

Compounding Pharmacy: Properly Display Current Licenses, Permits

2025-10-31T18:09:19-05:00August 8th, 2023|Categories: Compliance, Administration/Management, Blog, Community Pharmacy|Tags: , , , , |

Compounding Pharmacy

PCAB Accreditation Standards require compounding pharmacies to be compliant with all federal, state, local, and nonresident licensure/permit requirements, as applicable.

Copies of current licenses and/or permits, if applicable, must be displayed within public view in a prominent location of the pharmacy and any additional locations or branches.

PCAB Standards

Standard TCRX1-A: The organization is an established entity with legal authority to operate and has a physical location with the appropriate licensure, Articles of Incorporation, or other documentation of legal authority.

The standard applies to an established entity with legal authority to operate that has the appropriate Articles of Incorporation, or other documentation, of legal authority.

Legal authority is granted to one individual, members of a Limited Liability Corporation (LLC), a Board of Directors (usually referred to as the governing body), and as allowed in state statutes for the appropriate type and structure of the organization. The entity, individual, or organization has a copy of the appropriate documentation or authorization to conduct business.

If state or applicable local law requires a license or permit, the organization posts the current copy in a prominent location in all locations/branches and/or in accordance with appropriate regulations or laws. The organization will display all licenses and/or permits required in the pharmacy operation in an area of public view:

  • Resident state board of pharmacy permit/license.
  • Nonresident board of pharmacy permit/license as required, if applicable.
  • Drug Enforcement Administration (DEA) registration.
  • State controlled substance license, if applicable.
  • Pharmacist licenses.
  • Pharmacy Technician licenses/certificates, if applicable.
  • Biohazard generator permit or appropriate contract, as required.

Tips for Compliance

  • In addition to appropriate documentation or authorization to conduct business, compounding pharmacies must post copies of all current federal, state, and local licenses and permits in a prominent location of the pharmacy and ensure they can be viewed by customers.
    • Copies of nonresident licenses/permits must also be posted by compounding pharmacies that ship medications into other states.
Megan Reed

Megan Reed, LPhT, CPhT, HDDP, Program Lead, ACHC

Megan is a Certified Pharmacy Technician (2007), who started out her career working at an internship at the CHASS Center, in Detroit, MI.  This experience solidified what she wanted to do in life, which was to help people.  She has worked in two different PCAB Accredited compounding pharmacies.   One designated a 503B Outsourcing Facility.  During that time she was in Quality Assurance, and Lead Technician roles.  Reed diversified during her 14 year career, by also working in hospital outpatient pharmacy.  She is currently the first pharmacy technician hired to work for PCAB (Pharmacy Compounding Accreditation Board).  Reed is also a member of the Pharmacy Clinical Team, at ACHC (Accreditation Commission for Health Care) in Cary, NC.  The main focus of her expertise is in non-sterile, sterile, and hazardous compounding.

Here for You

ACHC is your partner in accreditation. For more information, contact your Account Advisor, email customerservice@achc.org, or call (855) 937-2242, ext. 458.

 

Accreditation Commission for Health Care:  ACHC is excited to give ACA Fellows and Members access to special pricing options and educational resources for their nationally recognized accreditation services. Members can use their unique code to receive a $250 discount off accreditation when submitting an application online at cc.achc.org. They can also use their discount code to receive $50 off when purchasing a workbook or registering for a workshop through www.AccreditationUniversity.com.

 

ESI / TRICARE Re-Initiating Recoupment Actions

2025-11-02T16:23:21-06:00September 17th, 2020|Categories: Compliance, News Release, Regulatory Issues|Tags: , , |

from ACA Corporate Member, Frier Levitt, Attorneys at Law

Express Scripts, Inc. (“ESI”), following a period of stay in its April 7, 2020 recoupment action, has resumed its efforts to recover funds from certain pharmacies who submitted claims to TRICARE in 2015, this time, with no indication of slowing down. Specifically, compounding pharmacies subject to this recoupment action begun to receive letters dated September 1, 2020 resuming the recoupment action, specifying that ESI must receive the appeal and all supporting documentation within 90 days from the September 1, 2020 date, by November 30, 2020. However, the Defense Health Agency (“DHA”) expressed a shift in focus from its original focus on allegations pertaining to lack of patient/prescriber relationship to those pertaining to a lack of medical necessity for the claims at issue. While the focus has shifted slightly, the strategy to appeal such determinations has remained largely the same. The clock has begun ticking and DHA has made it clear that refunds to pharmacies for moneys already withheld will only be adjusted if and when the Pharmacy appeals the action, and, even then, only if the appeal is successful. It is clear that DHA and ESI are not backing away from this recoupment action and are prepared to press on, full steam ahead.

ESI Re-Initiates Recoupment Action

After a two month stay on the recoupment actions, Express Scripts, Inc. (“ESI”) began sending out letters dated September 1, 2020 stating that the new appeal deadline is set 90 days from the date of the letter, such that the appeal and all supporting documentation is now due November 30, 2020. This recoupment action was initiated by ESI on April 7, 2020 when some pharmacies received the letter recouping on claims submitted in 2015 for TRICARE beneficiaries (read more here). By mid-June, several hundred pharmacies received the same letter initiating a recoupment with a letter dated April 7, 2020. Finally, at the direction on the Defense Health Agency (“DHA”), ESI stayed the recoupment action effective June 25, 2020 until further notice (read more here).

After ESI’s letter temporarily halting the recoupment action, no further information was provided to pharmacies until August 23, 2020 when DHA responded to a series of questions sent in July by Pharmacy Audit Assistance Services National (“PAAS”). Within their responses, DHA has implemented several changes to how the recoupment action was to proceed. None of these changes, however, indicate that the allegations set forth within the initial recoupment action will be retracted – only that they have been slightly modified – nor that the moneys previously recouped will be refunded to the pharmacies. Moreover, DHA and ESI have made it clear that neither DHA nor ESI were planning to refund pharmacies for the recouped amounts unless and until the applicable pharmacy submits an appeal which successfully counters DHA and ESI’s allegations. ESI and DHI have expressed that, only then, will any adjustments be made to the moneys already withheld.

Instead, DHA re-instated the original recoupment action and switched gears from focusing on the patient-prescriber relation to focusing on the medical necessity of the claims at issue itemized within the original ESI recoupment letter dated April 7, 2020. However, this shift in focus is still grounded in DHA’s internal investigation which found that the corresponding prescribers to the prescriptions at issue allegedly did not bill TRICARE for a corresponding patient visit. While the allegation that there was a lack of medical necessity indicates a slight shift from the original recoupment allegation, ultimately the issues facing pharmacies in seeking medical records from prescribers to combat the allegations remain the same.

Amongst the documentation to be provided to refute the allegation that the prescription s were not medically necessary, DHA additionally stated in its August 23, 2020 letter that prescriber attestations, which ESI previously indicated would be insufficient to respond to the appeal, may be accepted to support the medical necessity of the prescription if the attestations clearly identify the specific patient, prescription, date of service and medical necessity of the prescription as originally prescribed. In addition to the attestations, medical records and pharmacy records will also be accepted in order to support the medical necessity of the prescriptions.

Pharmacies who have received either the initial recoupment letter or the letter suspending the recoupment action should be on the lookout for the latest correspondence from ESI dated September 1, 2020 and should use the time before the appeal deadline to gather documentation in order to support the medical necessity as well as the patient prescriber relationship. While ESI is moving forward with a recoupment action, if ESI makes the determination that claims were submitted for prescriptions lacking the requisite medical necessity, ESI may proceed to terminate the pharmacy from its network and pharmacies must be mindful of potential False Claims Act exposure because the claims at issue are claims submitted to TRICARE, a federal payor (read more here). As a result, it is of utmost important that the allegations are appealed in a timely manner.

How Frier Levitt Can Help

Frier Levitt understands the intricacies and the variety of issues that pharmacies face with these recoupment actions. If you have received an initial letter dated April 7, 2020, a suspension letter dated June 25, 2020, or a renewal letter dated September 1, 2020, we can assist you in appealing this recoupment action on behalf of your pharmacy.

Jonathan E. Levitt, Esq.
Co-Founding Member
Frier Levitt, LLC
jlevitt@frierlevitt.com
973.618.1660

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