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News Release

ESI / TRICARE Re-Initiating Recoupment Actions

2020-09-17T11:26:53-05:00September 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

ACA Welcomes New Dermatological Compounding Training Instructor, Kathleen Jackson

2020-09-04T12:46:18-05:00September 4th, 2020|Categories: compounding training, News Release|Tags: |

We are proud to announce that Kathy Jackson, RPh, PhD (HC), FAPC, has joined the ACA Faculty and will be teaching our Dermatological Compounding with Pain Management course this Fall as well as providing on-site training.

Kathy has over three decades of experience in compounding, beginning with owning and operating her own community pharmacy and later becoming a PCAB Surveyor and independent consultant. She has aided 503(a) and (b) pharmacies with FDA inspections and 483 responses.

Kathy is a fellow of IACP (now APC) and a certified sterile compounding trainer. She served two terms on the IACP board, and as the President of the IACP Foundation, as well as chair of the compounding section of the Texas Pharmacy Association. In 2015-2016, she co-authored two IJPC articles on Root Cause Analysis. In 2018, she achieved the CISC certification from Critical Point for State Board Inspectors. Kathy’s passion lies in helping pharmacies maintain compliance through self-assessment.

Kathy’s wide range of experience as a pharmacy owner, PCAB surveyor, and consultant gives her a unique perspective on the practicalities of how class attendees can implement what they’ve learned while maintaining high quality standards and compliance. We are fortunate to have her join our faculty.

Update on ESI/TRICARE Clawbacks

2020-07-09T09:35:49-05:00July 9th, 2020|Categories: Compliance, News Release, Regulatory Issues|Tags: , , |

from ACA Corporate Member, Frier Levitt, Attorneys at Law

Beginning early this year, at the request of the Defense Health Agency (“DHA”), Express Scripts, Inc. (“ESI”) sent the first wave of letters to some of the pharmacies within its network recouping on claims that had been submitted to TRICARE during the 2015 year. These letters are particularly notable, as they focus on the results of a DHA investigation – as distinct from an audit – a particularly powerful tool that permits ESI an enlargement of the limited lookback period on claims permitted in audits. In the vast majority of instances, the discrepant claims ESI has identified relate to claims submitted for compounded drugs. Though ESI’s letters reference a host of potential reasons for the recoupments, ESI’s chief concern appears to be based in allegations that medications were dispensed to patients in instances in which the requisite prescriber patient relationship did not exist.

What constitutes a valid prescriber patient relationship often varies from state to state and is very heavily dependent on the fact. Several factors can be viewed as “red flags” when assessing whether an prescriber patient relationship exists, including the location of the patient relevant to his or her prescriber, telemedicine arrangements, certain marketing arrangements, or that the prescriber did not submit claims for a patient visit on or around the time the prescription was written.

Between late May and early June, ESI sent out another wave of letters – which were dated April 7, 2020, but were not received until several weeks thereafter – initiating recoupment actions to pharmacies based on allegations of lack of prescriber patient relationship. As with the first wave of ESI letters, the letters received by pharmacies in late May and early June related to claims submitted to Tricare during the 2015 year and generally identified claims for recoupment related to compounded medications. Each of these letters broadly alleged that prescriptions had been dispensed absent a valid prescriber patient relationship; these letters provided no additional information as to the basis for these allegations, or what methodology had been employed to derive those findings.

In instances where pharmacies have formally requested administrative review, ESI has responded with another form letter, providing somewhat confusing and vague statements about what documents would be required in order to validate the prescriber patient relationship. While ESI’s response letters explicitly requested “detailed substantiation that a prescriber patient relationship existed within the 365-day period prior to the date the claim(s) were filled,” the undertones of the letters suggested that mere attestations from prescribers would not be enough to validate the prescriber patient relationship. ESI also requested that if the pharmacies were to provide medical records to demonstrate the existence of a prescriber patient relationship, they would need to additionally provide metadata or similar validating facts that substantiate the records’ creation date. In addition to this metadata request, ESI stated in the form letters that it is requiring an affidavit from prescribers and the pharmacy attesting that they understand that they are subject to criminal prosecution under federal and State law for providing false statements and medical records, a tactic we believe to be particularly abusive given the incentive it provides for prescribers – the individuals in possession of the relevant documentation – to refrain from providing any statements or information to pharmacies in need of assistance.

ESI’s most recent blast correspondence, dated June 25, 2020, states that, under the direction of DHA, ESI has suspended all further recoupment actions which were based on the lack of a prescriber patient relationship as initiated in the letters dated April 7, 2020 (but, as outlined in the letter, were intended to be dated June 1, 2020) until further notice. Via additional correspondence with our office, ESI clarified that, due to DHA’s direction to ESI to suspend the recoupment action, the 90-day time period by which to appeal the recoupment action is being stayed as of June 23, 2020 until further notice. This most recent correspondence from ESI additionally states that ESI will be “unable to answer any questions regarding this matter until DHA provides further information which will be coming in the next few weeks.”

While these new suspension letters may provide some relief to pharmacies, they leave a lot of uncertainty as to when and if the recoupment actions and the offsets will resume. Specifically, we view the statements contained within the June 25th letter, when considered in conjunction with ESI’s past actions, as a “slow down” of ESI’s recoupment efforts, tied primarily to procedural defects, rather than an abandonment or withdrawal of those efforts.

Pharmacies who have received initial recoupment letters should be on the lookout for the referenced June 25, 2020 suspension letter and should utilize this period of “stay” of the recoupment action to continue to vigilantly prepare appeals and gather the relevant documentation to combat ESI’s allegations. Moreover, ESI has, in some instances, already begun its offset for pharmacies who continue to submit claims to ESI. In many instances, this offset began before the applicable pharmacies had received ESI’s original letter initiating recoupment. We urge pharmacies to continue to monitor their remittances to determine whether the recoupment process has actually been suspended.

While these letters dated April 7, 2020 are recoupment actions, if ESI makes a determination that a prescriber patient relationship is lacking, ESI may also proceed to terminate the pharmacy from its network, which may have implications for future credentialing with pharmacy benefit managers other than ESI. Moreover, because ESI’s investigation pertains to claims submitted to TRICARE, a federal payor, pharmacies must also be mindful of the potential for False Claims Act exposure. As a result, it is of utmost important that these findings are appealed in a timely manner.

Clawbacks

National Pharmacy Organizations Unite to Take a Stand Against Racial Injustice

2020-06-08T12:05:41-05:00June 5th, 2020|Categories: News Release, Uncategorized|

June 5, 2020

Today, the American College of Apothecaries and other national pharmacy organizations published a Joint Statement to Condemn Racial Injustice and Discrimination.

As a response to recent events highlighting the deep-rooted injustices resulting from systematic racism, we join our fellow organizations in pledging to engage in intentional dialogue and action to advocate against prejudice and discrimination.

READ THE COMPLETE STATEMENT HERE

ACHC and American College of Apothecaries Promote Safety and Quality

2020-02-13T14:35:22-06:00February 13th, 2020|Categories: Administration/Management, News Release, Pharmacist Training|

Cary, NC – Accreditation Commission for Health Care (ACHC) announces the renewal of its partnership with American College of Apothecaries (ACA), an organization dedicated to advancing the entrepreneurial spirit of member pharmacists through education, innovation, mentoring, fellowship, and training.

“Both ACHC and ACA are committed to advancing safe practices and quality through education and collaboration,” said Jon Pritchett, ACHC Program Director. “ACA’s role in the original establishment of PCAB points to the visionary leadership for which they are recognized in serving their members and the industry as a whole. The renewed partnership between ACHC and ACA represents an ongoing expression of our organizations’ shared values.”

This partnership agreement also allows ACA members and Fellows to receive special pricing on ACHC’s Pharmacy Accreditation services, including services provided by the Pharmacy Compounding Accreditation Board (PCAB), and discounts on ACHCU educational resources that can help prepare ACA member pharmacies for accreditation.

“ACA’s partnership with ACHC underscores our organizations’ commitment to quality and best practices in pharmacy,” said Susan Bartlemay, RPh, FACA, FACVP, FAPhA, Executive Vice President, American College of Apothecaries.

“We are thrilled to announce that ACHC is now offering a $500 discount on accreditation services to our members. We encourage our members to continually strive to deliver the highest standards of health care as demonstrated by the ACHC programs and support them in their efforts.”

ACHC offers a broad suite of pharmacy accreditation solutions, including accreditation for Community Retail, Specialty, Sterile/Non-Sterile Compounding (PCAB), Mail Order, Infusion, and Long-Term Care services. Companies seeking to distinguish themselves within the pharmacy market also can obtain distinctions in Rare Diseases and Orphan Drugs, Oncology, Infectious Disease Specific to HIV, Nutrition Support, and Hazardous Drug Handling.

ACHC PCAB Accreditation offers programs for non-sterile (ref. USP <795>) and sterile (ref. USP <797>) compounding services. PCAB assesses the compounding process based on a specific set of standards that concentrate on the quality and consistency of compounded medications while incorporating performance improvement and ongoing compliance requirements.

ACHC is known for providing value, integrity, and the industry’s best customer service, and  is dedicated to helping providers address challenges as demand for healthcare services continues to grow.

ACHC’s flexible, educational approach makes it the provider’s choice for accreditation. ACHC assists providers throughout the accreditation process by offering access to personal account advisors, clinical and regulatory support, and program-specific educational resources. With no annual fees, ACHC offers cost-effective, competitive pricing to help providers achieve their accreditation goals.

For more information on ACHC Accreditation programs and services, or to download ACHC Accreditation Standards, visit www.achc.org, email customerservice@achc.org, or call (855) 937-2242.

For 80 years, the American College of Apothecaries (www.acainfo.org) has been dedicated to the advancement of professional practice in independent community pharmacy through education, entrepreneurship, and mentoring. The Fellows and members of ACA are committed to best practices in pharmacy and quality healthcare for their communities.

ACA offers a way for pharmacists, pharmacy technicians, marketers, and students to connect with other pharmacy professionals to discuss areas of mutual interest and strengthen individual practice. This effort is supported through webinars, on-demand continuing education (CE), compounding classes, conferences and other events. ACA’s educational programming is available to all pharmacy professions, including non-members.

For more information on the American College of Apothecaries, visit www.acainfo.org.org, email info@acainfo.org, or call (901)383-8119.

Memories of 50 Years as a Woman Pharmacist…..

2019-10-10T17:05:16-05:00October 10th, 2019|Categories: Blog, News Release|

Women Pharmacist Day, October 12, 2019, is a wonderful opportunity to recognize those women who have made – and continue to make – contributions to pharmacy practice and our patients’ lives.

Fifty years ago, I became a registered pharmacist. I’ll be honest—some days it seems like yesterday; and other days, it seems like forever ago.  Oh, the changes I have seen through the years in equipment, practice, education, and gender of pharmacists.

Changes for women, as well as pharmacy practice, are enormous.  Women are now 50% of pharmacy students, computers are the norm, and pharmacists are counseling patients.  Pharmacy practice today is nothing like 50 years ago.

When I finished pharmacy school, there were only seven women in my graduating class of 77. We hung together and most of us joined Kappa Epsilon, the women’s professional pharmacy fraternity on our campus. Today, this organization still supports women in pharmacy but has evolved with the times and welcomes men as well as women.

Upon graduation, I took a staff pharmacist position with a small chain.  At this time, retail pharmacists made the most money and most retail pharmacies were owned and operated by individual pharmacists.  In many cases, the men were paid more than the women.

Because you were a young female, everyone would always ask to see the pharmacist and then tell you that you were too young to be a pharmacist and they wanted to talk to the “man” pharmacist.  Many customers would leave rather than have a female help them (that was usually because they wanted to buy condoms which were kept behind the counter!).

Since there were few women pharmacists older than me, most of my mentors were men.  However, I attended many pharmacy meetings which afforded me the opportunity to meet many women who were “firsts” and pioneers in pharmacy who then became my mentors.  To name a few: Marjorie Coghill, Metta Lou Henderson, Joy Donaldson, Gloria Francke (first female to receive the Remington Honor Medal), Mary Lou Andersen (first female Speaker of APhA House of Delegates among other firsts), Evelyn Timmons (first female president of ACA), Mary Munson Runge (first female president of APhA), Hazel Pipkin (first female president of Texas Pharmacy Association) and many others.  Without these women and the trails they blazed, many of us women would never have reached the leadership positions that we have enjoyed through the years.

So on behalf of the American College of Apothecaries and the American College of Veterinary Pharmacists, I want to say “Thank You” to the women pharmacists who came before me and helped pave the way, to the women pharmacists who supported me in pharmacy school and the early years of my practice, to the women pharmacists who work tirelessly everyday to help improve their patients’ health and the health of our communities, to the women pharmacists who serve on the board, committees, and faculty of the American College of Apothecaries and the American College of Veterinary Pharmacists, and to the pharmacy students who will be the women pharmacists of the future.

Sincerely,

Susan Bartlemay
Susan Bartlemay, RPh, FACA, FAPhA
Executive Vice President
American College of Apothecaries  |  American College of Veterinary Pharmacists

Susie Business 2
Susan Bartlemay Executive Vice-President American College of Apothecaries American College of Veterinary Pharmacists

ACA’s Response to the Update on USP Compounding Standards

2019-09-25T14:45:00-05:00September 25th, 2019|Categories: News Release, USP 795, USP 797|

On September 23, 2019, ACA received notification that due to ongoing appeals, implementation of proposed changes to USP Chapters 795 and 797 will not occur on December 1, 2019. This is good news for compounding pharmacy: the scope of the revisions to USP Chapters 795 and 797 – and the impact that the current revisions as written would have on maintaining patients’ access to compounded medications and on the preservation of local, independent community pharmacies’ ability to continue to compound—were too great.

ACA is committed to providing compounding training that reflects the USP Chapter Standards. We are in the process of updating the curricula for our 2020 live and online courses to reflect the proposed changes as they are currently written. Once USP makes a decision to deny or remand the ongoing appeals to Chapters 795 and 797, and communicates a new implementation schedule, we will adjust our revisions and training updates accordingly on our website.

If you have any questions about ACA compounding training or the inclusion of USP Chapter Standards in our curricula, please contact us at training@acainfo.org. Click here to read the notice from USP.

Sincerely,

 

Susan Bartlemay, RPh, FACA, FAPhA
Executive Director | CEO
American College of Apothecaries

Recognize & Celebrate Pharmacy With Recognition Days

2020-01-13T10:07:16-06:00September 25th, 2019|Categories: News Release|

Professional Awareness Days are a great opportunity to show your appreciation for the hard work that your staff does every day and market your pharmacy at the same time. There are several notable dates coming up, so start planning. For your convenience, we’ve compiled some links and ideas to get you started.

Throughout the Weeks Ahead:

  • Ahead of time: post signs around your pharmacy and on your website and social media alerting your patients about the upcoming recognition day and asking them to join you in showing their appreciation to your staff
  • Include information for your patients about the many services you and your staff provide and how the profession of pharmacy helps keep them healthy
  • Make each recognition fun & be creative — take photos of the events and post online
  • Use the official hashtags for each special day
  • Use the links below to discover more ways to promote each event!

Key Dates

September 25
World Pharmacists Day
#WPD2019 #WorldPharmacistsDay

Theme:  “Safe and effective medicines for all”

The theme for 2019 aims to promote pharmacists’ crucial role in safeguarding patient safety through improving medicine’s use and reducing medication errors. Show your support with graphics and a profile frame from the International Pharmaceutical Federation (FIP).

October 1-31
American Pharmacists Month

Theme: “Pharmacists: Easy to Reach, Ready to Help”

Visit the APhM website for marketing and promotional materials to wear or display and for event ideas for your practice setting.

October 12
National Women Pharmacists Day
#WomenPharmacistDay

Celebrate the significant gains that women have made in pursuing careers in pharmacy. Honor the trailblazers who have made such progress possible and the women working in your pharmacy today. Download a toolkit of graphics and ideas from the WPD website.

October 15
Pharmacy Technicians Day
#RxTechDay

Show your appreciation to pharmacy technicians for the important role they play in your pharmacy. Recognize and celebrate their dedication and hard work.

The links above have been provided as informational resources and as tools for our members to use to promote pharmacists and pharmacy technicians.

2019 ACA Member of the Year Awarded to Marisol Lopez

2019-02-27T10:16:07-06:00February 21st, 2019|Categories: News Release|Tags: |

ST. PETE BEACH, FL, February 8, 2019: The American College of Apothecaries presented the 2018 ACA Member of the Year Award to Marisol Lopez, RPh, MPH, FACA, FACVP, of f Trujillo Alto, Puerto Rico.

The award, established in 2013, recognizes an ACA Member for exceptional accomplishment and effort in serving his or her community and promoting community pharmacy through mentoring, entrepreneurship, and education, as well as support of the ACA.   The presentation was made during the Presidents’ Banquet Friday evening, at the College’s 2019 Annual Educational Conference hosted at the Don CeSar.

Marisol Lopez excels in the field of education and mentoring as she has dedicated herself to the promotion of community pharmacy and the continued development of pharmacy professionals.

As an ACA Fellow, Lopez has served the organization through roles on the ACA Board of Directors and as a compounding training class instructor. She has been instrumental in expanding ACA’s compounding training into the Caribbean and is an outstanding teacher and mentor to class participants.

A 1990 graduate of the University of Puerto Rico (UPR) with a bachelor’s degree in Pharmaceutical Sciences, Lopez completed a Master’s degree in Public Health with a major in Public Health Administration in 2007.

Lopez works as an Adjunct Professor at the School of Pharmacy of Puerto Rico and has offered continuing education presentations for the Continuing Education Division of the School of Pharmacy, University of PR, and the Puerto Rico Pharmacists Association (Colegio de Farmaceuticos de PR). In addition, Lopez has collaborated in the development of the compounding sections of the Pharmacy Act of Puerto Rico.

In 2014, Lopez received the honor of being named the Innovative Pharmacist of the Year Excellence in Innovation Award by the Puerto Rico Pharmacist Association, sponsored by Upsher-Smith Laboratories.

At the present, Lopez is the President of International Society of Pharmaceutical Compounding (ISPhC) based in Spain, a member of the International Academy of Compounding Pharmacists (IACP) and a Fellow of the American College of Apothecaries (ACA) and the American College of Veterinary Pharmacists (ACVP).

ACA 2018 Member of the Year Marisol Lopez with 2018 Chairman of the Board Ryan Oftebro

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