Potential HIPAA Violations Lead to $1.3 Million Settlement

According to a September 11, 2023 news release from the U.S. Department of Health and Human Services (HHS), “L.A. Care, the largest publicly operated health plan in the country paid $1,300,000 to settle” potential HIPAA Security Rule violations. The settlement comes at the end of two Office for Civil Rights (OCR) investigations into L.A. Care Health Plan (“LACHP”). One of the investigations was due to a large data breach resulting from a mailing error which caused member identification cards to be mailed to the wrong members. The other investigation stemmed from a processing error which allowed L.A. Care covered members to log into the LACHP payment portal where they could potentially view the name, address, and member identification number of another LACHP member.

In addition to the $1.3 million dollar settlement, LACHP has agreed to a comprehensive corrective action plan and three years of monitoring from OCR. They must develop and distribute HIPAA compliance policies and procedures for performing a risk analysis and risk management plan. Additionally, they must implement and adhere to their new policies and procedures.

As quoted in the HHS release, OCR Director Melanie Fontes Rainer aptly stated, “Breaches of protected health information by a HIPAA-regulated entity often reveal systemic, noncompliance with the HIPAA Rules.” She goes on to advise, “HIPAA-regulated entities need to be proactive in ensuring their compliance with the HIPAA Rules, and not wait for OCR to reveal long-standing HIPAA deficiencies.”

Follow the advice of our PAAS analyst team (and the advice of the OCR Director!), and proactively review your HIPAA program to ensure you are compliant with all the Rules before you potentially find yourself at the very expensive end of an OCR investigation.

Those of you with the PAAS National® Fraud, Waste and Abuse (FWA) & HIPAA Compliance Membership have a wealth of knowledge available at your fingertips in your Policy & Procedure (P&P) Manual. This manual is automatically generated after the Risk Analysis and P&P Questionnaire have been completed. Account administrators or officers can download a full copy of the P&P Manual for further review. Highly trained PAAS analysts are also here to answer HIPAA questions, discuss HIPAA concerns, guide you through the intricacies of breach notifications (if a breach occurs), and so much more.

If your pharmacy does not currently have the PAAS FWA & HIPAA Compliance Membership, we suggest scheduling a services overview to obtain additional information about this one-of-a-kind, customizable FWA & HIPAA program! PAAS National® – helping community pharmacies gain confidence and peace of mind. Be Proactive. Be Prepared. Be Protected.®

Calculating Days’ Supply – Pancreatic Enzymes

Auditors target pancreatic enzyme prescriptions like Creon® and Zenpep® due to high cost and ambiguous directions.

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Directions are often vague and only indicate how many capsules to be taken with meals and snacks. Pharmacies can generally assume three meals, but if the prescription does not specify how many snacks a patient is allowed, or the maximum number of capsules per day, an auditor will look to recoup for “non-specific directions.”

The solution to this problem is contacting the prescriber at the time of fill to clarify the number of snacks or the maximum daily dose and make a clinical note on the prescription. This information must also be added to the patient label to avoid possible recoupment for a “misfill” on audit.

PAAS Tips:

Albuterol HFA Inhaler Substitution Refresh

There have been many new albuterol HFA NDCs released since the June 2020 article, First AB-Rated Generic for Proventil® HFA Approved, and since albuterol inhaler substitutions require an extra level of consideration due to not all NDCs being equivalent, a refreshed chart was in order.

The chart below shows albuterol products grouped into their respective Therapeutic Equivalence (TE) Code category – AB1, AB2, or BX. As a reminder, substitution can occur at the pharmacy level if the substitution involves two therapeutically equivalent products and is allowed per state law.

Example: AB1 inhaler 6.7 gm Proventil® would be able to be substituted for AB1 inhaler 6.7 gm Sandoz albuterol HFA. 

If a substitution to a non-equivalent is required, it would be necessary to contact the prescriber and make a corresponding clinical note documenting the conversation.

Example: Prescription written for AB1 inhaler 6.7 gm Proventil® but PBM rejects claim stating an AB2 inhaler such as 8.5 gm Lupin Pharmaceuticals albuterol HFA is required. 

Refer to the article linked above for examples of how to handle substitutions based on how a prescription is written.

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Product NDC Labeler Package Size FDA Application Number Brand or Generic TE Code
Proventil® HFA 66758-0959-85 Sandoz 6.7 gm N020503 Brand AB1
Albuterol sulfate HFA 00054-0742-87 Hikma Pharm. A207085 ANDA Generic
Albuterol sulfate HFA 00781-7296-85 Sandoz N020503 NDA Authorized Generic
Albuterol sulfate HFA 69097-0142-60 Cipla A209959 Generic
Albuterol sulfate HFA 72572-0014-01 Civica A209959 Generic
Albuterol sulfate HFA 76282-0679-42 Exelan Pharm. A209959 Generic
ProAir® HFA 59310-0579-22 Teva Resp. 8.5 gm N021457 Inactive; manufacturing ceased Oct. 2022 AB2
Albuterol sulfate HFA 00093-3174-31 Teva Pharm. N021457 NDA Authorized Generic
Albuterol sulfate HFA 45802-0088-01 Padagis A203760 Generic
Albuterol sulfate HFA 68180-0963-01 Lupin Pharm. A209954 Generic
Ventolin® HFA 00173-0682-20 GSK 18 gm N020983 Brand BX
Albuterol sulfate HFA 66993-0019-68 Prasco Labs N020983 NDA Authorized Generic
ProAir RespiClick® 59310-0580-20 Teva Resp. 1 EA N205636 Single Source Brand
ProAir® Digihaler® 59310-0117-20 Teva Resp. N205636 Single Source Brand

USP 800 – The Struggle is Real…

Are you compliant with USP 800? While USP 800 became official on December 1, 2019, it was informational only and not compendially applicable. With the recent updates to USP 795, Nonsterile Compounding and USP 797, Sterile Compounding in November 2022, USP 800 was effective as of November 1, 2023.

USP 800 is not just for compounding pharmacies as it defines the quality standards for the safe handling of hazardous drugs in all healthcare settings, with the goal to minimize exposure to healthcare personnel, the patients in your pharmacy, and to the environment.

You might still be asking, does my pharmacy need a USP 800 program?

The answer is yes! All healthcare settings, including community pharmacies, should now have a “handling of hazardous drugs” program in place and while, USP itself is not an auditing entity, there are other agencies that may audit including OSHA, EPA and most likely State Boards of Pharmacy, many of which have already committed to doing so. The safe handling of hazardous drugs is now considered a “standard of practice” so implementation is essential to protect the health and safety of your employees.

Are you struggling with the multitude of requirements?

This isn’t one of those “throw it together in an afternoon” type of programs. PAAS can help! PAAS’ customized USP 800 Compliance Program provides:

  • A detailed Program Guide walking you through everything from the why to the how
  • Annual web-based training to keep the team up to date including a quiz to assess competency
  • A USP 800 Compliance Program Policy & Procedure manual tailored to the unique needs of your pharmacy with minimum interruption to workflow
  • An easy-to-use Assessment of Risk (AoR) tool to help you create custom containment strategies for each drug and its unique dosage form.

Call (608) 873-1342 to sign up for PAAS’ USP 800 Compliance Program and you can immediately get started on setting up your program in hours, not days!

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
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