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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.

VaccineFinder and MedFinder Updates for Pharmacies

2020-09-02T10:40:44-05:00September 1st, 2020|Categories: Immunizations|Tags: , |

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 locatinghealth@healthmap.org 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.

Pharmacy Profession asked to help recruit volunteers to participate in COVID-19 vaccine clinical trials

2020-09-02T14:11:51-05:00August 28th, 2020|Categories: COVID-19, Public/Community Health|

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.

FAQ:  https://www.coronaviruspreventionnetwork.org/clinical-studies-faq/

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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!

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

Four Things You Need to Know About the ESI/Tricare Clawback

2020-07-30T15:55:32-05:00June 29th, 2020|Categories: Compliance, Regulatory Issues|Tags: , , |

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:

  1. 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.
  1. 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.
  1. 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.
  1. 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.

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.

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