Regulatory Issues

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

2026-01-05T16:29:30-06:00January 5th, 2026|Categories: Compliance, Aseptic Technique, compounding, compounding training, Continuing Education, Documentation, FDA, Medication Safety, Patient Safety, Pharmaceutical Training, Pharmacy Practice, Policies & Procedures, Quality Assurance, Regulatory Issues, SOPs, Sterile Compounding, USP 797, USP 800|Tags: , , , , , , , |

Are you ready to take sterile compounding to the next level? This 4-hour accredited CE virtual course is designed to empower you with essential knowledge and skills for excellence in aseptic processing and FDA compliance.

Why Enroll?
Sterile compounding requires precision, compliance, and the latest knowledge in regulatory standards. This course provides comprehensive training to help you stay ahead in the ever-evolving pharmaceutical landscape.

What You’ll Learn:
By the end of this engaging course, participants will be able to:
1️⃣ Master aseptic processing and terminal sterilization methods.
2️⃣ Understand release testing requirements, including visual inspections, sterility, and endotoxin testing.
3️⃣ Navigate key FDA guidance documents with confidence.
4️⃣ Ensure proper selection of components used in compounding.
5️⃣ Recognize the importance 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: 25 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.

Veterinary Compounding Essentials Course | August 14–15, 2026

2025-12-15T16:26:52-06:00December 15th, 2025|Categories: Continuing Education, Compliance, compounding, compounding training, Patient Safety, Pharmaceutical Training, Pharmacist Training, Pharmacy Practice, Pharmacy Technician, Regulatory Issues, Veterinary Compounding, Veterinary Medicine, Veterinary Toxicology|Tags: , , , , , , , |

Veterinary Compounding Essentials is a live, comprehensive training course designed for pharmacists, pharmacy technicians, and pharmacy professionals who compound medications for animal patients or are interested in expanding into veterinary compounding practice. This program provides a practical foundation in veterinary pharmacotherapy, regulatory requirements, compounding techniques, and patient safety considerations unique to non-human species.

Participants will explore the regulatory framework and professional standards that impact veterinary compounding, including prescription requirements, verification processes, and the veterinarian-client-patient relationship (VCPR). The course addresses differences among companion animals, performance animals, and food-producing animals, emphasizing how regulations and drug use vary by species and intended use.

Instruction includes veterinary drug information resources, toxicology considerations, and species-specific risks associated with drugs, excipients, flavors, and preservatives. Attendees will review common veterinary dosage forms, administration devices, and formulation considerations to support safe and effective compounding.

The program also covers calculations, hands-on compounding principles, and strategies for developing and growing a veterinary compounding practice, including communication with veterinarians and practice marketing considerations.

This course blends knowledge-based and application-based learning, offering attendees practical tools and confidence to support veterinary patients while maintaining compliance and safety.

Expand your skills in veterinary compounding and enhance patient care for animal patients with this live, comprehensive training course.

What attendees said:

  • “It was a very informative course and small class made it easy for one on one question with the instructor. The lab experience was great as we were able to make multiple formulas and learned new techniques to incorporate in compounding practice at my store. I had chance to meet other pharmacist who have similar vision as mine and shared ideas with each other to excel in business. Lunch was great on both days.”
  • “The Veterinary Compounding Essentials course provided an excellent overview of the key requirements for compounding medications for animals. The instructor was highly knowledgeable and tailored the content to meet our individual needs. The hands-on lab experience, combined with expert supervision, gave me the confidence to perform compounding independently.”
  • “This course was so fun and I enjoyed learning about everything vet pharmacy related. This course was the best decision I made to help further my compounding knowledge post graduation!”
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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/application-based program for 15 contact hours (1.5 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

Sterile Compounding Certificate Program | June 18–20, 2026

2025-12-15T16:08:04-06:00December 15th, 2025|Categories: Certificate Program, Compliance, compounding, compounding training, Continuing Education, Documentation, Hazardous drug handling, Pharmaceutical Training, Pharmacist Training, Pharmacy Law, Pharmacy Technician, Quality Assurance, Regulatory Issues, Sterile Compounding, USP 797, USP 800|Tags: , , , , , , |

The Comprehensive Sterile Compounding Certificate Program is a live, in-depth training program designed for pharmacists and pharmacy technicians involved in sterile compounding. This certificate-based course provides a structured, practice-focused review of sterile compounding standards, regulatory requirements, documentation, training, and quality systems to support safe and compliant operations.

Participants will examine the legal and regulatory framework governing sterile compounding, including applicable FDA guidance and key USP standards such as USP <797> and USP <800>. Emphasis is placed on understanding how these requirements translate into daily practice and inspection readiness.

The program includes detailed instruction on documentation, quality assurance and quality control programs, policies and procedures (SOPs), and personnel training and competency requirements. Attendees will review expectations for facility design, environmental monitoring, equipment, and workflow as they relate to sterile compounding compliance.

A focused module on hazardous drug handling addresses facility requirements, engineering controls, PPE, personnel training, and assessment of risk, with alignment to current safety and regulatory expectations.

This certificate program combines didactic instruction and application-based learning, offering attendees the opportunity to strengthen their sterile compounding knowledge while reinforcing compliance, safety, and best practices.

Advance your sterile compounding knowledge and compliance skills with this comprehensive, certificate-based training program for pharmacists and pharmacy technicians. Registration is below.

What attendees said:

  • “This class was super helpful in increasing my knowledge and technique in the lab. I highly recommend it.”
  • “It’s a great class! Anyone want to get into sterile or the ones already doing it, should really consider taking this class.”
  • “With nearly 20 years of sterile compounding practice and exposure, this course reinforced my knowledge and skills in this area. I am more confident after this course.”
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Fundamental Compounding with Pharmacy Law | March 19–21, 2026

2025-12-15T15:58:45-06:00December 15th, 2025|Categories: Continuing Education, Compliance, compounding, compounding training, Hazardous drug handling, Pharmaceutical Training, Pharmacist Training, Pharmacy Law, Pharmacy Practice, Pharmacy Technician, Regulatory Issues, USP 795, USP 800|Tags: , , , , , , |

Fundamental Compounding with Pharmacy Law is a live, multi-day compounding course designed for pharmacists, pharmacy technicians, and pharmacy professionals seeking a strong foundation in both compounding practices and regulatory compliance. This course integrates compounding principles with pharmacy law to support safe, compliant, and high-quality compounding operations.

Participants will review the regulatory framework governing pharmacy compounding, including applicable federal and state considerations and key United States Pharmacopeia (USP) standards. Emphasis is placed on documentation, quality assurance, policies and procedures, and compliance requirements essential to day-to-day compounding practice.

The course includes instruction and hands-on training in common nonsterile dosage forms, such as capsules, molded dosage forms, and topical preparations. Participants will learn proper techniques, equipment use, quality control measures, and best practices to support consistency and patient safety.

A dedicated session on hazardous drug handling addresses requirements for facilities, engineering controls, PPE, and personnel training, with alignment to applicable USP standards and safety expectations.

This program combines didactic instruction and application-based learning to reinforce compounding knowledge, regulatory awareness, and practical skills in a structured, in-person environment.

Build a strong foundation in compounding and pharmacy law with this comprehensive, live training designed for pharmacists, pharmacy technicians, and pharmacy professionals. Registration is below.

What attendees said:

  • “The ACA Fundamentals of Compounding Course was one of the best decisions I’ve made for my pharmacy. The small, hands-on setting, focus on USP 795/800, and opportunity to network with both new and experienced compounders made it invaluable. Highly recommend!”
  • “The instructor effectively highlighted important topics and used real-world examples to support learning. The small class size made it easy to ask questions and have open discussions.”
  • “The class was great. The networking with other pharmacists from different areas was great. I was immediately able to take the knowledge learned and apply it in my store.”
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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 application/certificate-based program for 21 contact hours (2.1 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

Nonsterile Compounding Home Study | 11-Hour PTCB-Recognized CE

2025-12-15T12:49:15-06:00August 20th, 2025|Categories: Continuing Education, Community Pharmacy, Compliance, compounding, compounding training, DEA, FDA, Hazardous drug handling, Home Study, Medication Safety, Patient Care, Patient Safety, Pharmaceutical Training, Pharmacist Training, Pharmacy Law, Pharmacy Practice, Pharmacy Technician, Policies & Procedures, Professional Development, Professional Growth, Regulatory Issues, SOPs, USP 795|Tags: , , , , , |

This knowledge-based, enduring home study is designed for compounding pharmacists and pharmacy technicians seeking a comprehensive foundation in nonsterile compounding practices. The program provides a broad overview of nonsterile compounding, with a strong focus on regulatory compliance, standards, dosage forms, and pharmaceutical calculations essential to safe and effective compounding.

Participants will review the regulatory landscape governing nonsterile compounding, including applicable federal and state considerations and key United States Pharmacopeia (USP) standards, with emphasis on USP <795>. The program also addresses the roles and responsibilities of compounding personnel, facility and equipment requirements, documentation, quality assurance, and patient safety considerations.

The curriculum includes in-depth discussions of the most common nonsterile dosage forms prepared by compounders, such as solutions, suspensions, topical preparations, capsules, suppositories, transdermal preparations, and tablet triturates. Each section explores formulation principles, preparation techniques, and quality control measures relevant to practice.

A dedicated pharmaceutical calculations module provides detailed explanations and practical examples to help learners develop proficiency in calculations commonly used in compounding. This module serves as a guide to reinforce accuracy, consistency, and confidence in compounding calculations.

This 11-hour knowledge-based home study is a PTCB-Recognized Education/Training Program, ensuring a quality and standardized learning experience for pharmacy technicians. The program is offered in a self-paced, text-based format and does not include a video component, allowing learners to complete the material on their own schedule.

Build a strong foundation in nonsterile compounding and strengthen your skills in compliance, dosage forms, and pharmaceutical calculations—registration is below.

What participants said:

  • “Covered all of the material in an effective manner.”
  • “Several topics were covered in detail.”
  • “I could complete the program at my own pace, which allowed me to take the time needed to fully process and understand the material.”

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 11 contact hours (1.1 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

WEBINAR: DSCSA—13 Year Implementation and 2024 Update

2025-10-31T07:41:18-05:00September 10th, 2024|Categories: Webinar, Pharmacy Law, Regulatory Issues|Tags: , , |

Date and Time of Activity
Tuesday, October 1, 2024
11 am EDT/ 10 am CDT/ 9 am  MDT/ 8 am PDT

Pharmacy professionals play a crucial role in protecting patient from drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

Enacted in 2013, DSCSA is taking over 13 years to implement. Pharmacies need to prepare for the DSCSA requirements with a November 27, 2026 FDA enforcement implementation to receive or exchange transaction information electronically and conduct package level verification. The implementation of systems to produce serialized transaction information in a readily retrievable manner and develop SOPs for regulatory or trading partner transaction data requests will take time, and pharmacies should start today, if they have not already, to ensure compliance with the new enforcement implementation date. That said, despite the DSCSCA granting an exemption for small dispensers until November 27, 2026, pharmacies should be aware of their obligations to make appropriate purchases and maintain inventory purchase information in accordance with their Pharmacy Benefit Manager (“PBM”) Provider Manuals and Agreements. PBMs continue to audit pharmacies to ensure their sourcing of inventory is valid and despite any exemption granted by the DSCSA, such audit measures are expected to continue.

Activity Description:

In this webinar, we will review the phased in implementation and provide update of 2024 and beyond.

At the completion of this activity, the participant will be able to:

  • Identify the DSCSA requirements for receiving, validating, and storing DSCSA Transaction Information (TI) and Transaction Statements (TS).
  • Describe the procedures for implementing electronic operability at the package level for traceability.
  • Identify the regulatory requirements and documentation needed for compliance with audit records, inspections, and other inquiries.
  • Explain the processes for verifying product legitimacy, including methods for quarantining, investigating, and reporting suspect products.
DSCSA - 13 Implementation and 2024 Update

Don’t miss this opportunity to improve your ability to implement best practices to protect patients from drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

Click below to register:


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.

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.

ACA WEBINAR: Legal Insights into Peptide & Semaglutide Compounding: Navigating FDA, State Boards, and Telemedicine

2025-10-31T12:26:56-05:00February 8th, 2024|Categories: compounding, Pharmacy Law, Regulatory Issues, Telemedicine / Telepharmacy|Tags: , , , |

Equip yourself with essential knowledge about the management and distribution of 503A compounded products, the intellectual property intricacies in peptide and semaglutide compounding, and understanding the FDCA and recent FDA guidance. Moreover, you will be able to assess the regulatory landscape effectively, ensuring your practices are in line with state laws and regulations.

Activity Description:

As the landscape of compounding peptides and semaglutide continues to evolve rapidly, a multitude of legal challenges and opportunities arise. This session aims to shed light on the pivotal developments and regulatory nuances in this dynamic sector. Our speakers will delve into critical topics such as the FDA’s current stance on peptide compounding, recent pronouncements from state Boards of Pharmacy, and the intricate legalities surrounding  brand manufacturers. Additionally, the webinar will explore the burgeoning realm of telemedicine and its implications for compounders, along with guidance on navigating the complexities of bulk chemical ingredients.

Legal Insights Into Peptide & Semaglutide Compounding ON DEMAND GRAPHIC

Don’t miss out on this opportunity to enhance your professional skills and understanding of semaglutide and peptide compounding!

Click below to register:

At the completion of this activity, the participant will be able to:

  • Discuss the management and distribution of 503A compounded products among DSCSA trading partners,
    encompassing transfers, dispensing, and oversight by state Boards of Pharmacy, particularly focusing on
    semaglutide and peptide compounding.
  • Evaluate the intricacies of intellectual property in peptide and semaglutide compounding and advertising.
  • Analyze the key aspects of the FDCA and recent FDA guidance on compounding peptides and semaglutide,
    including the legal trends involving compound semaglutide, manufacturer enforcement efforts, and the impact
    on telemedicine arrangements.
  • Assess the regulatory landscape by comparing state laws concerning pharmacies’ compensation and feesharing
    with prescribing physicians, within the context of compounded semaglutide and telemedicine practices.


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.

Speakers:

Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt’s Life Sciences Department. Her practice focuses on healthcare law; Food, Drug Cosmetic law; pharmacy law and regulatory issues; PBM issues; as well as pharmaceutical and medical device intellectual property including trademark, copyright, trade secret and all aspects of patent law (due diligence, prosecution, opinion work, litigation, and transactional matters). Dr. Rumore has over 15 years of law firm experience in the area of Food, Drug & Cosmetic Law and pharmaceutical intellectual property, counseling on early market opportunities for pharmaceutical clients particularly in the area of ANDA and 510K applications and all facets of Paragraph IV litigation.

Matthew J. Modafferi, Esq is a seasoned litigation and trial attorney with experience in healthcare law.  He focuses his practice on white collar defense and investigations, and complex civil litigation. As a Partner in Frier Levitt’s Healthcare and Life Sciences Litigation Department, Matthew’s practice is dedicated to representing healthcare clients in litigation matters including healthcare fraud, qui tam, and False Claims Act matters. Matthew also helps clients successfully navigate DEA inspections and investigations, state and federal OIG investigations, and government self-disclosures. Matthew previously worked as an Assistant United States Attorney in the Civil Division at the U.S. Attorney’s Office for the Eastern District of New York.  During his time as a federal prosecutor, Matthew represented the United States and its agencies in various affirmative and defensive matters, appearing before both the Eastern District of New York and the Second Circuit Court of Appeals. He successfully defended Executive Branch policies and initiatives, and prosecuted health care fraud qui tam and other False Claims Act cases.

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

Clawbacks

ACTION NEEDED NOW! Contact Your Legislators to Request Provider Status for Pharmacists Under Medicare

2020-08-14T11:29:20-05:00August 14th, 2020|Categories: Provider Status, Regulatory Issues|

Today, not yesterday, we need each of you to contact your Senators and Congressional Representatives asking them to push for Provider Status for pharmacists under Medicare.

We are almost there and COVID-19 can be the impetus to put us over the top. Think about services we as pharmacists are trained to do and could implement now if not for regulations—testing, triage, telehealth, and soon vaccinations. We are the most accessible healthcare providers and need to be allowed to practice at the top of our license. Granting pharmacists provider status under Medicare will increase access to necessary services for the most vulnerable populations, including seniors and the medically fragile.  Allowing us to receive compensation for our services will improve the overall public health of our nation.

Please contact your legislators now to request their support for provider status for pharmacists and to send them your comments. If you do not know your federal legislators or how to contact them, go to the following website: www.usa.gov/elected-officials.

Your help is needed now!

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