Specialty Pharmacy Paying the Price: $20 Million Settlement for Kickbacks and Copay Waivers

A September 30, 2023, Department of Justice press release outlined a recent settlement between the U.S. government and a specialty pharmacy based in Delaware. The pharmacy agreed to pay a settlement of $20 million to resolve allegations that they violated the False Claims Act and the Anti-Kickback Statute by paying kickbacks to patients in the form of routinely waived copayments and to physicians in exchange for providing patient referrals.

The government alleged that from August 2015 through May 2020, the pharmacy routinely waived copays for Medicare and TRICARE patients, regardless of any financial hardship need, to induce them to fill prescriptions at the pharmacy. Additional allegations include kickbacks to prescribers such as gifts, dinners, and free administrative and clinical support services to induce patient referrals to the pharmacy. The prescribers involved knowingly solicited and accepted the remuneration and have settled separately.

Two former employees, who acted as whistleblowers under a qui tam lawsuit to report these abuses to the government, will receive over $4 million as part of the settlement.

Make sure your pharmacy staff has implemented a robust set of FWA policies and procedures, including discussion of Anti-Kickback Statute, and are completing annual training on healthcare fraud, waste, and abuse. Protect your pharmacy by enrolling in the PAAS National® FWA/HIPAA Compliance Program today. Call us at (608) 873-1342 to get started.

You’ve Got Mail! Post-COVID-19 Mailing & Delivery Considerations

After three years of a Public Health Emergency (PHE) due to COVID-19, the Department of Health and Human Services (HHS) allowed the PHE to expire May 11, 2023. With the end of the PHE came the end of most PBM concessions, including those made in relation to mailing and delivery of medications. Therefore, re-training staff on the importance of adhering to PBMs’ signature, mailing, and delivery requirements will help curtail audit risk.

The remainder of this article will focus on adherent mailing and delivery practices.

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The largest PBMs (Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics, MedImpact), allow for delivery of prescriptions. However, OptumRx will only allow W-2 employees of the pharmacy to complete deliveries within a 100-mile radius of the pharmacy, prohibiting delivery of their medications via a contracted delivery service. Pharmacies who utilize a contracted delivery services (versus a common carrier like UPS, FedEx or USPS) must exercise due diligence to ensure they are HIPAA compliant and have undergone Fraud, Waste, & Abuse annual training in addition to being checked on the OIG & GSA exclusion lists.

PBMs are more restrictive with allowing prescriptions to be mailed. Caremark will allow mailing for up to 20% of the monthly claims submitted under their “Retail Pharmacy” definition. Anecdotally, Express Scripts has some degree of tolerance for mailing; however, it varies by situation (e.g., distance, drugs being dispensed and frequency). Humana, who usually completely restricts mailing prescriptions, is allowing their PHE concession on mailing prescriptions to continue until January 1, 2024. Consider this during open enrollment or put a plan in place to set patient expectations come 2024, if necessary.

PAAS Tips:

  • Check your state Medicaid requirements, as they may have had differing concession end dates
  • If your pharmacy is mailing out of state, check that state’s Board of Pharmacy for any licensing requirements
  • Be mindful with automatic mailing requirements, see September 2023 Newsline article, Automatic Prescription Refill Concerns
  • If you are seeking a compliance program that has exclusion checks, annual FWA/HIPAA training, and a one location where you can download all certificates and signatures at your fingertips, call PAAS (608) 873-1342 to add PAAS’ FWA/HIPAA Compliance Program. It’s more than training and exclusion checks – Attest with Confidence!

3…2…1…The Countdown is On to Complete Annual Fraud, Waste & Abuse Training

It is that glorious time of year again! Time for staff to be occupied not only with the daily activities of billing and filling medications, but also occupied with cough/cold/flu season, vaccine administration, answering Medicare Part D open enrollment questions, and holiday closures. Now is the time to ensure staff complete their annual Fraud, Waste & Abuse and HIPAA Compliance training since the December 31st deadline will be here before we know it!

Employees who are involved with filling, billing, dispensing or delivery of Medicare and/or Medicaid prescriptions are required to be trained within 30 days of hire (per PBM requirements) and at least annually thereafter. Per CMS Chapter 9.50.3, training and education for employees does include the CEO and senior administrators or managers. Relief pharmacists, students, interns, job shadows, and delivery drivers also need training. The training must cover FWA and General Compliance topics and must include details outlining your pharmacy’s specific policies and procedures of how you prevent, detect, and correct FWA.

Current PAAS National® FWA/HIPAA Compliance Program members can meet annual training requirements through the PAAS Member Portal. A few important things to note:

  • All employees must complete the 2023 FWA Modules 1-4 and review/sign the Employee Compliance Training Handbook and Code of Conduct to meet training requirements.
  • If a staff member misses the December 31st deadline, 2023 training cannot be retrospectively completed.
  • Account administrators that have employees with outstanding quizzes or signatures will receive email reminders from PAAS periodically through the rest of the calendar year.

If you are unsure of all the necessary requirements, contact PAAS at (608) 873-1342 today for more information on our comprehensive, and customized, FWA/HIPAA Compliance Program.

Fair Access for All: The Proposed Rule’s Potential to Strengthen Anti-Discrimination in Pharmacies

The Biden-Harris Administration is continuing to bolster the importance of equal access to health care and human services for individuals with disabilities through a new proposed rule. The Discrimination on the Basis of Disability in Programs or Activities rule will update and clarify the obligations stated in the original Section 504 of the Rehabilitation Act of 1973, enacted almost fifty years ago. Under Section 504, individuals with disabilities are afforded equal access to any federally funded program or activity and cannot be discriminated against due to their disability. Within the article released by the HHS Press Office on September 7, 2023, it states that the COVID-19 pandemic “shone a spotlight” on areas of discrimination, such as individuals being refused medical treatment due to their disability, inability to access medical equipment and websites, and being forced to receive treatments only in institutional settings. As a result, the Administration for Community Living along with the Office for Civil Rights suggested the following changes be made to the current implementation of Section 504:

  • Decisions on medical treatments cannot be based on biases or stereotypes, such as judgements that the individual will be a burden on others or beliefs that one’s life is less valuable
  • Clarifies the obligation health care and human services must provide access for web, mobile, and kiosk to all individuals
  • Establishes enforceable standards for access to medical equipment
  • Prohibits the use of value assessment methods that determine lower value on life-extension for people with disabilities when used to determine an individual’s access to aids, benefits, and services

It is becoming increasingly apparent that cultural competency and the ability to provide equivalent services across all patient populations is imperative. The first step to adhering to this new standard of care is ensuring staff has undergone Cultural Competency Training. Login to the PAAS Member Portal to view the on-demand webinar “Does My Pharmacy Really Need Cultural Competency Training?” for additional information.

Call PAAS National® (608) 873-1342 to add PAAS’ Cultural Competency Training to your membership.

Advances in Respiratory Syncytial Virus (RSV) Prevention

There are two RSV vaccines FDA-approved for people ages 60 years and older – AbrysvoTM and Arexvy®.

Trade name Manufacturer NDC Quantity Suggested Days’ Supply Time to administer
AbrysvoTM Pfizer 00069-0344-01 1 EA 1 day supply Use within 4 hours after reconstitution
Arexvy® GSK 58160-0848-11

CDC recommends that adults ages 60 years and older may receive RSV vaccination, using shared clinical decision-making (SCDM). This means that health care providers (including pharmacists) should talk to these individuals about whether RSV vaccination is appropriate for them.

  • Most vaccines recommendations are considered routine, catch-up, and risk-based where the default decision is to “vaccinate, unless contraindicated”.
  • There are a small number of vaccines including RSV and Hepatitis B that are recommended under SCDM where there is no default.
  • The Advisory Committee on Immunization Practices (ACIP) explains how SCDM differs from routine, catch-up, and risk-based immunization recommendations here.

Because of the SCDM workflow, the immunization action coalition (immunize.org) has not created a standing order template or screening checklist.

PAAS Tips:

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  • Medicare covers RSV vaccine under Part D
  • Administration to patients less than 60 years of age is off-label, not recommended by CDC, and very high audit risk
    • Important exception: As of September 22, 2023 CDC recommends that pregnant people obtain AbrysvoTM (only) between weeks 32-36 of pregnancy to reduce risk of RSV hospitalization for babies within first six months after birth. This recommendation is not in published/printed ACIP immunization schedule as of this writing; however, is an “addendum”.
  • Like all vaccines, pharmacies should maintain proof of administration as well as authorization to administer which may include a patient-specific prescription or a collaborative practice agreement/protocol.
    • The RSV vaccine is not officially part of published ACIP immunization schedule as of this writing, so pharmacists may not have independent prescribing authority as per state law or PREP Act.
    • While PAAS has not seen audits requesting documentation of SCDM, pharmacies should consider documentation of their conversation as part of the vaccine administration record

Biosimilar Advancements: Understanding the Latest Updates on Humira® with Cyltezo® and Abrilada™

At the time our April 2023 Newsline article Biosimilar Adoption for Humira® in 2023 was published, eight FDA biosimilars for Humira had been approved, and five more were pending approval. As of June, three additional biosimilars are in the market and three are still pending FDA approval. In October, Abrilada™ was granted FDA approval as an interchangeable biosimilar. Now, Abrilada™ along with Cyltezo® are the only two biosimilars that are interchangeable with Humira® without the intervention of the prescribing physician, depending on state pharmacy laws. The chart below

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from Cardinal Health’s biosimilar landscape overview provides a convenient summary.

FDA Approved

Product Company Estimated launch Interchangeability Designation Approved Citrate free Latex free
Abrilada™ Pfizer November 2023 Yes Yes Yes
Amjevita™ Amgen January 31, 2023 No Yes Yes
Cyltezo® Boehringer
Ingelheim		 July 1, 2023 Yes Yes No
Hadlima™ Organon July 1, 2023 No No Yes
Hadlima™ Organon July 31, 2023 No Yes
Hulio® Viatris July 31, 2023 No Yes Yes
Hyrimoz® Sandoz July 1, 2023 No No No
Hyrimoz® Sandoz July 1, 2023 No Yes No
Idacio® Fresenius Kabi July 2023 No Yes Yes
Yuflyma® Celltrion July 1, 2023 No Yes Yes
Yusimry™ Coherus July 1, 2023 No Yes Yes

Pending Approval

Product Company Estimated launch Seeking interchangeability Citrate free Latex free
Amjevita™ Amgen 2024; Phase III trials Yes Yes No
AVT-02 Teva Pending FDA approval Yes Yes Yes
MYL-1401A Mylan Phase III trials

PAAS Tips:

  • Not all biosimilars are interchangeable
  • When the FDA grants an interchangeable biosimilar designation, this means the biosimilar meets additional data requirements proving patients who alternate between the reference product and the biosimilar will have the same clinical result as patients who are being treated with the reference product alone
  • Abrilada™ is expected to be in the market at the end of November 2023
    • PAAS National® will update our Biologic Injectable Medication chart when Abrilada™ available
  • Some large payers are keeping Humira® on formulary for 2023, but others may not
    • Watch for soft rejects alerting pharmacies to preferred biosimilars
    • PBMs may allow Humira® to process, but severely underpay the claim. Try to bill the interchangeable biosimilar first, watching claim adjudication logic, and then consider Humira DAW 9, as appropriate

Audit Target: Linzess® Prescriptions

PAAS National® analysts have noticed an increase in audits targeting Linzess®. Linzess® is a focus of PBM audits not only because of the high cost, but also the manufacturer dispensing requirements. Not following FDA approved guidelines when dispensing this medication will likely result in full recoupment.

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Allergan, the manufacturer of Linzess®, has not provided evidence to the FDA for the safety and efficacy of this medication outside the original container. PAAS has reached out to Allergan looking for additional stability information to appeal audit recoupments; however, they have only confirmed the current requirements. Pharmacies can visit DailyMed for medication information, including How Supplied/Storage and Handling requirements under Section 16 of the drug label information.

While Linzess® is not the only medication required to be dispensed in the original container, it is frequently prescribed for patients in long-term care and for those who have medications in compliance packaging. Unfortunately, there are no exceptions for these situations, and the original container must be given.

Billing Linzess® for quantities other than increments of 30 capsules will make the claim an easy audit target for any PBM to identify the medication was not dispensed in the original container. This is true for many other medications with specific dispensing requirements as well. PAAS has created our Dispense in Original Container Chart, based on the medications we frequently see audited. You can find this and many other Day Supply Charts and Proactive Tips available on the PAAS Member Portal.

PAAS Tips:

  • When receiving a prescription of Linzess® written for a quantity less than 30 capsules, consult with the prescriber to discuss packaging requirements and obtain authorization for an appropriate quantity
  • Check all current prescriptions for Linzess® to ensure they are being dispensed per FDA guidelines
  • Consider adding shelf tags to this medication to flag pharmacy personal of requirement
  • Check if your software vendor can create an alert when NDCs are billed for quantities not valid with package size
  • Remember the Medicare Part D “short cycle dispensing” requirement to dispense no more than a 14-day supply on brand name oral solid medications in LTC settings has an exclusion for products that must be dispensed in their original container
  • Notify and discuss with LTC facilities the packaging requirements of this medication
  • Patients with compliance packaging will need to be educated on the importance of keeping this medication in the original container
  • Self-audit claims on a weekly or monthly basis to ensure appropriate dispensing

NEW PAAS Resource – Printable Signature Logbook

Many pharmacies have made the switch to electronic signature log capture, but paper signature logs have not gone away. Some pharmacies choose to maintain all signature logs through a paper log but those with an electronic signature capture system may still find themselves with the need for a paper signature log. Common reasons for paper logs include:

  • Electronic system outage
  • Curbside pick up
  • Delivery

To aid our member pharmacies in having appropriate documentation on their paper signature logs, PAAS National® is now offering a free printable signature book. To access this new tool, log onto the PAAS Portal, visit the Forms tab then download and the 400+ page Signature Logbook. Send the pdf to your local print shop and have them create a bound book. The form includes a place to document the date filled, acceptance or refusal of a consultation, prescription number, third party program, date picked up, signature, and more!

PAAS Tips:

  • Print at least one copy of the Signature Log Book to be used in the event of a system outage
  • An order form for the PAAS National® bound signature logbook is no longer required; simply log into the PAAS Portal and download the pdf of the Signature Logbook free of charge

OTC COVID-19 Test Prescribing Authority

Some pharmacies are wondering if they are allowed to continue prescribing OTC COVID-19 tests. The eleventh amendment to the Public Readiness and Emergency Preparedness Act (PREP Act) was issued on May 12, 2023 and extends PREP Act coverage through December 31, 2024 to allow licensed pharmacists to order and administer COVID-19 countermeasures including COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests.

Coverage for OTC COVID-19 tests varies by payer. See summary below:

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  • Medicare Part B coverage ceased as of May 12, 2023
  • Medicare Advantage plans may cover and pay for OTC COVID-19 tests as an added benefit
  • Medicaid coverage should continue through September 30, 2024
  • Commercial insurance coverage will vary; however, plans are not required to cover after May 11, 2023

PAAS Tips:

  • The eleventh amendment to PREP Act extends pharmacist prescribing authority through end of 2024
  • Point-of-sale edits should be relied upon to understand if OTC product is covered
  • Only dispense OTC COVID-19 tests upon patient request – do not autofill
  • Ensure you retain documentation of patient request using PAAS’ Attestation form

PAAS Battles MedImpact for DAW 0 Reimbursement on Semglee®

MedImpact sent a memo to network pharmacies dated May 22, 2023, with the subject line Semglee-YFGN (Preferred U-100 Long Acting Insulin). For their participating Medicare Part D plans, MedImpact requested pharmacies to dispense Semglee® (YFGN) at the brand reimbursement. Other insulin glargine products were considered non-formulary with a claim rejection response. The memo goes on to indicate that this ‘brand’ claim must be submitted with a DAW of 9 to get correctly reimbursed, meaning pharmacies that use a default DAW 0 could be incorrectly paid!

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Over the past several months, PAAS National® has been chiding the MedImpact Clinical Services team about this reimbursement decision and the correct biosimilar terminology and DAW utilization.

As pharmacies may be aware, Semglee® (YFGN) is not a brand, but an interchangeable biosimilar. As such, it does not require a DAW code and requiring a DAW 9 for Semglee® (YFGN) would be incorrect according to NCPDP guidance.

NCPDP description of a DAW 0:

This is the field default value that is appropriately used for prescriptions for single source brand, single biologic, cobranded/co-licensed, generic or interchangeable biosimilar products. DAW 0 is not appropriate for a multi-source branded product with available generic(s) or for a reference product with interchangeable biosimilar(s).

NCPDP description of a DAW 9:

This value is used when the prescriber has indicated, in a manner specified by prevailing law, that generic or interchangeable biosimilar substitution is permitted, but the plan’s formulary requests the brand or reference product. This situation can occur when the prescriber writes the prescription using either the brand, reference product, generic or interchangeable biosimilar name and the product is available from multiple sources.

While MedImpact considers Semglee® (YFGN) a brand for reimbursement purposes, it is classified by the FDA as an interchangeable biosimilar. The DAW code definitions (pasted above) from NCPDP state that DAW 0 would be appropriate. Pharmacies should not be negatively impacted financially for failing to use the DAW 9 code. This is not consistent with the industry and is an inappropriate use of DAW 9. DAW 9 states that an interchangeable biosimilar is permitted, but the Plan wants a brand or reference product. Semglee® is not a reference product in this definition (in reference to biologic drugs), Lantus would be.

After months of back and forth, PAAS was just informed by MedImpact that at the end of August, the POS message referencing DAW 9 for Semglee® (YFGN) was removed from all 2023 and 2024 Part D formularies. They are removing all messaging related to DAW 9 for insulin glargine and referencing “Please Dispense Brand for Generic Copay” with no requirement for a DAW 9 reference.

Your membership in PAAS helps us continue to advocate and fight for fair treatment of independent pharmacies.