MOORESTOWN, N.J., November 16, 2020 — Tabula Rasa HealthCare (Nasdaq: TRHC), a healthcare technology company advancing the field of medication safety, announces today a strategic alliance with the American College of Apothecaries (ACA). ACA, a national pharmacy organization dedicated to the advancement of professional practice in independent community pharmacy through entrepreneurship, will provide its members the ability to license TRHC’s medication safety software, MedWise™ and the opportunity to become MedWise Certified Advisors™ through TRHC.
“Partnering with Tabula Rasa HealthCare provides our members with access to innovative technologies, like MedWise, that will help them improve medication safety in patients who have a high burden of disease and complex medication regimens.” said ACA Executive Vice President/CEO Susan Bartlemay, RPh, FACA, FAPhA. “Our collaboration with TRHC furthers ACA’s commitment to providing exemplary pharmacy resources to community pharmacists.”
TRHC’s MedWise software provides science-based, actionable clinical intelligence to pharmacists, including a patient’s MedWise Risk Score™ (MRS). The MRS calculation uses active medication ingredients of a patient’s complete medication list, including over-the-counter supplements to predict the risk of medication problems and adverse drug events (ADEs). A published study, involving nearly 2,000 patients, found that a lower MRS correlated with fewer adverse drug events, emergency department visits, hospitalizations, and lower medical costs.
“As a former President of ACA, I understand how vital innovation and new technologies are in keeping community pharmacists at the top of their profession,” states TRHC Chairman and CEO Calvin H. Knowlton, PhD. “ Offering ACA members a way to identify high risk patients, and the opportunity to become certified MedWise Advisor™ is just the beginning of how our partnership will help improve medication safety in patients who are at risk for adverse drug events, due to their complex medication regimens.”
About Tabula Rasa HealthCare
Tabula Rasa HealthCare (TRHC) provides medication safety solutions empowering healthcare professionals to optimize medication regimens and reduce medication-related risk, specifically targeting adverse drug events. Utilizing its proprietary medication decision science technology, MedWise™, TRHC improves patient outcomes, reduces hospitalizations, and lowers healthcare costs. Additionally, TRHC offers an extensive clinical telepharmacy network across the U.S. Our suite of solutions are trusted by health plans and pharmacies nationwide to help drive value-based payment results. For more information, visit TRHC.com
About the American College of Apothecaries
For 80 years, the American College of Apothecaries (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.
This press release includes forward-looking statements that we believe to be reasonable as of today’s date, including statements regarding Medication Risk Mitigation technology. Such statements are identified by use of the words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “should,” and similar expressions. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the need to innovate and provide useful products and services; risks related to changing healthcare and other applicable regulations; increasing consolidation in the healthcare industry; managing our growth effectively; our ability to adequately protect our intellectual property; and the other risk factors set forth from time to time in our filings with the SEC, including those factors discussed under the caption “Risk Factors” in our most recent annual report on Form 10-K, filed with the SEC on March 2, 2020, and in subsequent reports filed with or furnished to the SEC, copies of which are available free of charge within the Investor Relations section of the TRHC website ir.trhc.com or upon request from our Investor Relations Department. Any forward-looking statement speaks only as of the date on which it was made. TRHC assumes no obligation and does not intend to update these forward-looking statements, except as required by law, to reflect events or circumstances occurring after today’s date.
ACA Fellows and Members have exclusive access to a 20% discount to the MedWise™ Decision Support Program. Click below to take advantage of this opportunity, and to elevate your pharmacy workflow through one-of-a-kind, science-based decision support tools.
On Pharmacy Technician Day we celebrate the important role that pharmacy technicians play in assuring patient health and safety and as an integral part of the pharmacy team. Thank you for your hard work and for all that you contribute—on the front lines and behind the scenes—to improve the pharmacy community.
Meet a few of our ACA, ACVP, and PPHI Pharmacy Technician Members below.
Pharmacy Regulatory Specialist | Integrated Medical Systems – IMS
ACA & ACVP Member since 2014
Changing life circumstances brought me to work at my very first pharmacy as a clerk and then technician. I decided very quickly that I wanted to know more and challenged myself to get my CPhT by the next testing date which was in 48 days. It was one of the hardest things I had to do but it left me eager to learn more! Soon my pharmacist realized my passion was perhaps too big for inside the pharmacy, so he sent me out to market a few days a week which led to new position as the Director of Marketing for Allenhill Pharmacy and Medical Supply. I attended marketing training and eventually was asked to up speak myself at a conference for the American College of Veterinary Pharmacists!
Since leaving Allenhill, I went on to become the Director of Marketing and Sales for a large pharmacy program and spoke at several national conferences regarding marketing your compounding business. I was then hired by the American College of Apothecaries and the American College of Veterinary Pharmacists where I oversaw the complete renovation of and directed the compounding training programs. I also assisted in running their Veterinary Compounding Conference. I moved on from there to work as a Director of Compounding for a local pharmacy and then became a Cleanroom Product Consultant for MSD, McKesson. In 2020 I joined Integrated Medical Systems – IMS, serving as the Pharmacy Regulatory Specialist to assist clients in tailored product selection and overall compliance.
There are no limitations to what you can do with your career as a pharmacy technician. Find your passion and see where it takes you.
Erin Michael, MBA, MS, CPhT
Director of Outside Sales | PCCA
ACA Member since 2019
I started working in pharmacy at the young age of 15. It was a community pharmacy in Encino, California, that had a video department and large gift department in addition to the pharmacy. I will never forget the relationship the pharmacist had with our patients and the difference the services we offered made in their lives. I was always interested in math and science, and I was blessed to work under such an amazing pharmacist. He was definitely an influence in my decision to pursue pharmacy as a career. He shared everything there was to know about pharmacy and before I knew it, I was counting pills, typing prescriptions, and interacting with doctors and patients.
After graduating high school (at 16 years old), I moved to Northern California to start college with a focus on pre-pharmacy. Unfortunately, life got in the way, and I had to take some time away from school to work full time. I applied for a position at the local pharmacy in Eureka, California, but what I found was that since I had moved, the Board of Pharmacy had implemented the registration process for pharmacy technicians. I had experience “teching” but now I needed to fulfill the requirements in order to get registered. After achieving that, I moved on and was one of the first groups of technicians in the country to be certified by the Pharmacy Technician Certification Board. I became a test question writer for the Certification Exam and tutored other fellow technicians who wanted become certified like me.
In 1996, I was introduced to compounding and fell in love. As someone who loves to cook, it felt very natural, and I instantly saw how we could help hospice patients, children with autism, and even dogs and cats. It was so rewarding, and I loved everything I was doing, but I wanted more. My boss was a CPhA member, and as I was researching to see if the Association would benefit me, I started looking at our Local Association and was instrumental in reviving it, oftentimes gathering fifty pharmacists and technicians for CE dinners and association meetings. I continued my advocacy in CPhA serving as Academy of Pharmacy Technicians (APT) Chair, APT Board of Trustees member, and on numerous other committees. Protecting and advancing the profession is a passion of mine, and I am so proud to say I am a pharmacy technician. While I never returned to complete my pharmacy degree, I did go back to get an MBA and an MS. Because of my love for compounding, I have moved on from working in the pharmacy to helping other community pharmacies add compounding to their practice and showing them how they can help patients through customized medications. I am active at the state and national level and most recently was elected to the Alliance for Pharmacy Compounding Board of Directors, a national alliance that protects the compounding profession.
The pharmacy world has changed a lot in twenty-five years, and technicians are a vital part of that world. We have continued to gain responsibility year after year, and I am excited for the future. I encourage not just technicians but everyone in pharmacy to get involved. It takes a village, and we need everyone’s help to continue to advance and protect the pharmacy profession. I am PROUD to be a Pharmacy Technician and encourage you to get involved. Be proud and remember your voice matters!
Becoming a pharmacy technician was one of the best decisions I have made. At the time I was going to school and viewed a pharmacy technician position as an interesting job to learn more and make a little extra money for tuition. Fortunately in school I was going straight for the money, History and French Literature.
As a new technician I learned an incredible amount from our two founding pharmacists, Salvador DeLaCruz and Sandra Sheppard. As much as I learned about pharmacy, I also learned about life. Salvador and Sandra taught the importance of hard work and taking care of our patients. They also taught me a lot about the art and science of compounding.
That was over 20 years ago and although many things have changed, the importance of hard work and taking care of our patients have not. Although I still have my active pharmacy technician license, I am now privileged to work with a team of over 100 talented pharmacy professionals at MedQuest Pharmacy in North Salt Lake, UT.
My role as CEO has changed to be a mixture between the head cheerleader and the water boy in order to make sure our team has the resources and support to be successful. We have a culture of everyone being focused on quality and compliance, regardless of their position. We have also expanded that focus to include advocacy and have had the privilege of meeting with many of our elected representatives here in Utah and in Washington, DC to build awareness about the importance of compounding and allow them to see it up close.
As a lifelong learner, I continued my formal education and training and look fondly upon the days of listen to Salvador and Sandra share life lessons. I also feel very privileged to learn from our licensed pharmacy technicians, pharmacists, support staff and other professionals on a daily basis. The greatest reward is to see the feedback from our patients and the significant difference we make in their lives.
Women Pharmacist Day, October 12, 2020, is a wonderful opportunity to recognize those women who have made – and continue to make – contributions to pharmacy practice and our patients’ lives.
I decided that I wanted to become a pharmacist when I was in high school in the 1970s. I thought that this would be a good, flexible career for a woman, especially if I wanted to have a family. I was going to be the hometown girl working in the only pharmacy in my small hometown of New Palestine, Indiana. I never would have imagined the pathways that opened for me when I graduated from Purdue University School of Pharmacy and Pharmaceutical Sciences.
While I was at Purdue, I learned about a relatively new specialty —nuclear pharmacy. I was totally fascinated by it. I did a summer internship in it and worked for a year as a nuclear pharmacist. As in many cases, “the grass is always greener on the other side” and it turned out to be a very demanding career. Although I did enjoy the work, it was not a good fit for my plans of being married and raising a family.
I then went back to my original plan of working in a retail pharmacy. I am a “people” person and liked the interaction with customers. The job did turn into very long hours and it interfered with other interests. One of my Kappa Epsilon Fraternity sisters recruited me into the hospital pharmacy setting. Hospital pharmacy opened a lot of doors for me. There were a variety of options that I could do in a hospital – working in the outpatient pharmacy, working on the units, working in the central pharmacy, and homecare, but the area that really called to me was compounding. It was a huge lab with different gadgets and tools that I had never used or seen anywhere else. The pharmacist was always working with the clinical pharmacists and medical staff to come up with unique treatment options for patients. We were connected with the Indiana University School of Medicine and Riley Hospital for Children, so compounding was not only a specialized area, but a necessity because of our unique patient populations.
When the compounding pharmacist retired, I eagerly applied for the position and I have been the compounding pharmacist for the entire health-system since 1993. I absolutely love what I do, despite some of the administrative drama in hospitals, and it has opened more doors for me. After 15 years, I went back online, to get my PharmD through the University of Florida. To graduate, I had to do a project and I chose a project to counsel patients and/or their caregivers about their compounded medications and helped them to find pharmacies to compound them after discharge. I published my study in the International Journal for Pharmaceutical Compounding (IJPC) which was a new publication at the time and was asked to be a feature author for hospital topics. Wow! I didn’t see that one coming. I loved writing in high school and college, but never expected to use those skills to become a professional writer as well as a pharmacist.
My published articles have opened other doors too. I have been invited to give presentations all over the world. I am also now giving live continuing education presentations, as well as developing written CEs. I have traveled to places that I never would have thought possible. I have been asked to be a contributing author for pharmacy and medical textbooks. I even wrote and published my own book, Compounding Guide for Ophthalmic Preparations.
Because of my commitment to compounding and my growing reputation as an expert compounding pharmacist, I have been able to get involved in a lot of unique opportunities. During this time, I also went back to school again to get my Masters from the University of Florida in Pharmaceutical Policies and Outcomes. I served one and a half cycles on the USP Expert Committee on Compounding. I am currently serving on an advisory committee for the Indiana State Board of Pharmacy to help revise and write the compounding regulations for the state of Indiana. I have also been selected to serve on the FDA PCAC committee for the next three years.
I am and have always been actively involved in my pharmacy fraternity, Kappa Epsilon. I became an officer at the local level and eventually became the President of the state alumni chapter. I eventually became involved nationally and served on the Grand Council. The “behind-the-scenes” bug had bitten me. As a member and eventually a full fellow of ASHP, I have served on several national committees and presented at the annual and Mid-year meetings. When I joined IACP, I soon ran for to become a member of the Board of Directors, serving 2 terms. Later, I was asked to join ACA as a full fellow and found myself again running to serve on the Board of Directors. Any organization that I have joined, I just don’t want to pay my dues and sit back – I WANT TO BE ACTIVELY INVOLVED.
My activities and involvement have also gotten me through the darkest time of my life – losing my son, Daniel, to suicide in 2018. I was running for Vice President of ACA at the time and I almost quit everything. You never recover from losing a child, especially under unnatural circumstances, and for a while I was a little lost, but now I have a different perspective on life. I want to continue to be involved in all of my interests, enjoy life, spend time with my friends, colleagues and family, and do everything to the best of my ability. You never know what tomorrow will bring. I am looking forward to serving all of you as your ACA President in 2021!
Linda F McElhiney, PharmD, RPh, MSP, FACA, FAPC, FASHP, DPLA
Team Lead Compounding Pharmacist
Indiana University Health
Vice-President, Board of Directors
American College of Apothecaries
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.
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.
VaccineFinder and MedFinder now offer flexible methods for pharmacies to update their vaccine and antiviral drug supply through both automated and manual reporting options.
The VaccineFinder website and platform have been upgraded and participating pharmacies can now update supply estimates for routine adult and child vaccines, and any travel vaccines that they carry.
Having timely and accurate information available in these applications will be especially important this influenza season, and CDC wants to ensure pharmacies are well represented so that people can find them to get their flu vaccine or fill their antiviral drug prescription.
Attached are provider factsheets, which share details on how these systems work and how to enroll. The VaccineFinder team will also host a series of information and training webinars for interested and participating providers (dates below). Pharmacies can register using the links below, and email email@example.com with any questions.
NOTE: Pharmacy entities with multiple practice sites (chains, pharmacy networks, etc) are able to combine data for all their sites into one CSV file and upload onto the Locating Health provider portal. Alternatively, if they have the capability to setup a centralized data feed for reporting, HealthMap’s technical team can work with these sites to automate this process. The attached files include the CSV file template and import documentation that outlines the process in detail. The webinars scheduled in September will also demonstrate these processes and provide the opportunity for Q&A.
The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health (NIH) to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the networks to address the pressing need for vaccines and monoclonal antibodies (mAbs) against SARS-CoV-2.
The network is seeking the assistance of pharmacists and pharmacy personnel to inform the public of the opportunity to participate in the clinical trials. More information and the link to volunteer can be found at the COVID-19 Prevent Network website.
There are materials available to pharmacists that can be used to share with patients, communities, family and friends. A special referral code (RXRX) has been created for individuals to include when signing up that identifies pharmacy as the source of referral and demonstrate pharmacy’s impact.
The development and release of effective vaccines against COVID-19 is dependent upon recruiting sufficient numbers of individuals to participate in the vaccine clinical trials, especially individuals within these targeted demographics:
People with underlying medical conditions
People with greater chances of exposure at their job
People who live or work in elder-care facilities
People over age 65
People who work in jails or prisons
People from racial and ethnic groups that have been impacted in greater numbers by the epidemic, such as African Americans, Latinx, and Native Americans
Individuals interested in volunteering complete a short online survey that includes some personal questions and entry into a registry. The purpose of the screening registry is to create a list of potential volunteers who want to take part in current or future COVID-19 prevention clinical trials. Individuals must be 18 years or older to participate. Participation is voluntary.
COVID-19 prevention study participants will be compensated for their time. COVID-19 prevention study participants CANNOT get infected with SARS-CoV-2 or get COVID-19 illness from the study vaccine.
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.
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.
By Ernest P. Gates Jr., Dennis Lyons, Gary McCrory and Paul O’Connor
[ June 29, 2020] Compounding pharmacies across our nation have opened their mail this month to find an unpleasant surprise: Express Scripts, Inc. (ESI), on behalf of the Department of Defense and Tricare, the health care program for the military, is seeking to recoup claims it paid for certain compounded medications provided to its members in 2015 – yes, that is five years ago.
ESI is specifically interested in claims for compounded medications prescribed by physicians when there is no record that the patient had an office visit with the physician. Tricare was the subject over the last several years of substantial fraud driven by illegal marketing enterprises that sent compounded medications to veterans who never requested them, and billed the insurer many millions of dollars for these unwanted and unneeded medications.
Tricare is clearly trying to clean up its operations and recoup payments made to these criminal enterprises, however, this effort is also impacting hard-working compounding pharmacists who make an honest living serving patients with needs that cannot be met by commercially manufactured preparations.
If you have received the ESI letter, here are four important things to know:
Take the letter seriously. We have heard from several pharmacists who were not planning to respond, and we have told them to not respond would be a mistake. Their thinking was that they did nothing wrong and to respond would create a precedent that would mean responding to an avalanche of subsequent requests from ESI and other PBMs. A non-response will only result in further efforts by ESI to recoup the funds and could create unwanted legal problems and even the possibility of a criminal investigation or prosecution.
You need help. This effort by ESI is not the place where you quickly compose an email, count to three, and hit “send.” Unfortunately, we are hearing of cases where this has happened. We advise all of our clients to engage an attorney to draft the response and to consider using a consultant to not only review the calculations, but to work collaboratively with your attorney to provide a comprehensive and forceful response. To do otherwise might be like trying to put toothpaste back into the tube.
Scrutinize ESI’s math. It would be wrong to assume that ESI’s calculations are correct. ESI may be including the copayment in their calculations or recovering “spread pricing” – the difference between what the pharmacy is paid and the actual amount billed to their clients. Each prescription’s paid amount should be reviewed. Your submission and payment records are the best resource to validate your submission. Prescription records should be thoroughly reviewed. For instance, if a key element was left off of the face of the prescription, such as the prescriber’s DEA number, but the script was prescribed by a physician known to the patient, ESI may include the prescription in its recoupment.
This is not an audit; it is an investigation. It is important to not think of this process as an audit. Audits are relatively routine matters: records are reviewed and reconciled, findings are presented and then you respond and potentially reach a resolution. ESI has made clear that this is an investigation that could lead to criminal charges. Tricare is operated with public funds, so charges will carry additional weight and will be harder to defend. America’s active military and veterans rightfully hold an exalted place in our national firmament and those alleged to be profiting from their service will confront major challenges.
The ESI clawback is only for 2015 and only for Tricare claims, and it is quite possible – likely, even – that ESI will also undertake recovery processes for claims paid between 2016 and today and claims paid on behalf of other ESI clients, and it is important to get this response right.
ESI has set a response deadline of June 30 to those pharmacies it is targeting. There is no time to waste.
Ernest P. Gates Jr. is a pharmacist and is president & CEO of Gates Healthcare Associates, a consulting firm with expertise in pharmacy operations, audits and regulations, as well as PBM operations. Dennis Lyons, Gary McCrory and Paul O’Connor are associates at the firm. Gates Healthcare Associates is not a law firm and does not provide legal representation.
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