2024 Self-Audit Series #3: Invoice Audits

The number of invoice audits continues to rise from Medicaid, and PBMs, across the board. This investigational audit is a way to potentially identify false or phantom claims. Auditors will reconcile the claims billed by a pharmacy during a certain timeframe, with the purchases made. This process ensures the pharmacy had inventory on hand to dispense for the claims they billed. Many PBMs, including OptumRx®, Elixir®, and Express Scripts® request pharmacies provide a full dispensing history for further reconciliation.

Some inventory audits are frequently combined with a desk audit. PBMs like Caremark request a high number of prescriptions, signature logs, and proof of copay collection. The amount of data a pharmacy is required to provide can be very overwhelming and time consuming. Performing internal, “mock audits” may help you be better prepared when receiving an invoice audit request.

Pharmacies must be diligent in following PBM requirements for purchasing. Audit recoupments can easily reach hundreds of thousands of dollars when invalid purchases are not accepted.

PAAS Tips:

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  •  Wholesaler:
    • Keep a running list of wholesalers you are purchasing prescription and over-the-counter (OTC) items billed as prescriptions
    • Vet each wholesaler to ensure they meet PBM requirements and can provide pedigrees in accordance with FDA Track and Trace Law
    • Each wholesaler must meet state licensing requirements
  • PBM Specific:
    • OptumRx requires National Association of Boards of Pharmacy (NABP) Drug Distributer Accreditation, formerly known as VAWD
    • Caremark and Express Scripts require all diabetic supplies be purchased from an “authorized distributor”
    • Caremark requires notification and approval of any bulk purchasing the pharmacy makes
    • Caremark auditors now require original invoices for any pharmacy-to-pharmacy transfer, including MatchRx and Rxeed
    • General:
      • Keep copies of all invoices and proof of purchases for 10 years as required by Medicare Part D retention requirements
      • Adhere to Return to Stock policy and be sure claims are reversed appropriately
      • Be sure the NDC you billed is the same as the NDC you are dispensing
      • For tips on performing a self-audit, see our January 2020 Newsline, Self-Audit Series #12: Invoice Audits

2024 DMEPOS Series #3: Ostomy Supplies

Many pharmacies struggle with DMEPOS audits due to the complexity in medical billing and the onerous documentation requirements. Medicare Part B suppliers need to be able to produce all the required documentation if audited, and make sure all documentation meets Medicare Part B standards. This DMEPOS series is intended to help you understand these complexities and gather the needed documents.

In particular, you should be able to show the following if audited on ostomy supplies:

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  • Standard Written Order (SWO)
  • Medical Records
    • Beneficiary must have a surgical created opening (stoma) to divert urine or fecal matter outside the body
    • The location, construction and skin condition surrounding the stoma must be discussed in the medical record
    • Diagnosis must be documented in the medical record as well as submitted on the claim for coverage consideration
    • Diagnosis driven by the type of ostomy the beneficiary has:
      • Colostomy – opening into the colon (large intestine)
      • Ileostomy – opening into abdominal wall (small intestine)
      • Urostomy – opening into abdominal wall that connects to urinary tract
    • Continued medical need can be verified by:
      • Initial medical need being met, the ongoing need for ostomy supplies is assumed to be met.
      • The beneficiary meeting the medical guidelines, no further documentation is required
    • Covered diagnoses can be found in the Local Coverage Determination (LCD) and Policy Article
  • Proof of Delivery
  • Proof of Refill Request and Affirmative Response
    • Required if delivered or mailed

Other considerations include:

  • Ostomy supplies are not separately payable when in a covered home health stay
  • Barrier (also known as a Wafer or Faceplate) – protects skin from stoma output and keeps the pouch in place
    • Solid barrier
    • Liquid barrier – liquid OR spray and individual wipes OR swabs may be used but not both
  • Pouches – can be one-piece or two-piece
  • Tape and adhesive – an AU (Item furnished in conjunction with a urological, ostomy, or tracheostomy supply) modifier code must be billed for tape and adhesive
  • If a continent stoma:
    • use only one type of supply per day
    • can be a stoma cap, stoma plug, stoma absorptive cover or gauze pads
  • Quantity of supplies needed depends on the type of stoma, condition of skin surface, location, and construction

PAAS Tips:


Audit Preparedness in Long-Term Care Claims: Implementing Proactive Measures

The practice of LTC pharmacy is different – look no farther than the dichotomy between prescriptions and orders. While state laws may be vague or unclear, resulting in pharmacists using professional judgement, PBMs have their own requirements. Do PBM Provider Manuals (and auditors) view LTC differently? The answer may surprise you—not as much as one may think and following the “LTC is different” mindset may lead to a lot of extra work (or recoupments) if you find yourself with an audit. Insufficient documentation for Long-Term Care (LTC) prescription claims is a topic PAAS National® analysts cover frequently during audit preparation consultations with members operating combo shop pharmacies and/or closed door LTC pharmacies. Our analysts are experts in understanding the documentation requirements for both retail and LTC claims and want you to be comfortable and confident in your documentation as well. One reference tool the PAAS analyst will utilize when educating pharmacies …

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is the publicly available Humana Guidelines for LTC. As found in the Humana reference, pharmacies should be prepared to provide the following information for LTC claims (which can be applied broadly to most PBMs):

  1. Prescription hardcopy requirements
    1. Patient name
    2. Date of issuance
    3. Name of the drug
    4. Strength of the drug
    5. Dosage form of the drug (if applicable)
    6. Directions for use
    7. Documented duration of therapy (e.g., number of refills, clear start and stop dates, duration of therapy written by prescriber)
    8. Prescriber’s DEA number (if applicable)
    9. Prescriber’s printed name and signature
  2. Signature log requirements
    1. Patient name
    2. Date of service
    3. Prescription number(s)
    4. Facility name
    5. Date of delivery to facility (handwritten)
    6. Signature of individual who accepted delivery at the facility

Apart from the facility name and the small nuances with duration of therapy, the elements above should look very familiar as they are the same elements prescriptions for retail claims should have. Other similarities between retail and LTC requirements include:

  • Must dispense within the PBM’s return to stock window
  • Must not delivery prior to billing
  • Must have appropriate documentation for override codes utilized for successful claim adjudication
  • The 11-digit NDC billed must match all 11 digits of the NDC dispensed
  • Proof of copay collection (or attempts to collect) is required
  • The directions must be specific to allow for the days’ supply to be mathematically calculated and accurately billed (following the Can You Bill It as 30 Days?, where applicable)

While daily operations and workflow in a closed-door LTC pharmacy may be vastly different from that of a retail pharmacy, the pharmacy still has the same requirement to provide proof of a valid prescription, proof of dispensing, proof of copay collection, and proof of sufficient inventory. Failing to have sufficient documentation could mean claim recoupment, accusations of fraud, waste, or abuse, and (potentially) contract termination.

PAAS Tips:

V-Go® All-In-One Insulin Delivery Patch

The V-Go® all-in-one insulin delivery patch is a disposable device approved for use in patients with Type 2 diabetes. Because it is “disposable” and not “durable”, it is covered under Medicare Part D (rather than Part B). The device comes in three different strengths that deliver a basal dose of 20 units, 30 units, or 40 units of rapid acting U-100 insulin (such as Humalog® or Novolog®) per 24 hours. Additionally, each device can deliver up to 36 units of on-demand bolus insulin for mealtimes (in 2-unit increments). Prescribers will need to issue two separate prescriptions for patients – the prescription for #30 V-Go® devices to last one month and a prescription for the rapid acting U-100 insulin to put into the devices (typically 20-30 mL).

According to the instructions for patient use, patients must fill each device completely each day and each device holds slightly more than it can actually deliver. The amount of insulin each device can hold is referred to by the manufacturer as the Minimum System Daily Insulin Requirement and the amount of insulin each device can deliver is referred to as the Minimum Reservoir Dosing Capacity.

The table below summarizes each device and provides an estimated day supply to bill based on the number of vials of insulin and the amount of insulin used to fill each device.

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V-Go® Device Billing Quantity Minimum Reservoir Dosing Capacity Minimum System Daily Insulin Requirement Estimated Days’ Supply of Insulin
10 mL 20 mL 30 mL
V-Go® 20 30 EA 0.56 mL (56 units) 0.65 mL (65 units) 15 days 30 days 46 days
V-Go® 30 30 EA 0.66 mL (66 units) 0.75 mL (75 units) 13 days 26 days 40 days
V-Go® 40 30 EA 0.76 mL (76 units) 0.85 mL (85 units) 11 days 23 days 35 days

PAAS Tips:

  • Be careful to submit the correct days’ supply based on the amount of insulin each device can hold and not the amount it can deliver
  • There may be situations where billing greater than a 30 days’ supply will result in a higher copay or different pharmacy reimbursement – remember to always submit the correct days’ supply unless the PBM helpdesk advises differently (and be sure to document a clinical note)
  • See our Considerations for Billing Insulin Vials: Medicare Part B vs Part D resource for more information about disposable, and durable, pump billing

The Alarming Toll of HIPAA Breaches: Over 41 Million Individuals Affected in 2022

Each year, the Health and Human Services Office for Civil Rights (OCR) composes detailed reports on HIPAA compliance and breaches of unsecured Protected Health Information (PHI) and delivers them to Congress. The latest report is that of events from the 2022 calendar year. These reports can teach us about weaknesses in the HIPAA policies and procedures of other entities, the most common types of threats from malicious actors, and help educate staff on identifying vulnerabilities in the pharmacy’s safeguards during their next Risk Analysis.

Here are a few of the key takeaways from the 2022 Annual Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance:

  • There was a 17% increase in the number of HIPAA complaints received from 2018 to 2022
  • There was a 107% increase in the number of large breaches reported from 2018 to 2022
  • OCR was able to resolve 87% of the complaints before initiating an investigation; pre-investigation closures could have resulted because:
    • The complaint was against an entity not covered by the HIPAA Rules
    • Allegations were about conduct that did not violate the HIPAA Rules
    • Complaints were untimely because they were not filed within 180 days of when the individual submitting the complaint knew or should have known about the act or omission that was the subject of their complaint
  • OCR completed 846 compliance reviews, of which 80% of the entities had to take corrective action or pay a civil money penalty
    • OCR may open a compliance review investigation “based on an event or incident brought to OCR’s attention, such as through the media, referrals from other agencies, or based upon patterns identified through multiple complaints alleging the same or similar violations against the same entity
    • OCR initiated 676 compliance reviews that did not arise from complaints but were instead initiated by OCR after a breach report was filed. Of that 626 of these stemmed from breach reports affecting 500 or more individuals, 2 were from breach reports affecting less than 500 individuals, and 48 were brought to OCR’s attention by other means

The 2022 Annual Report to Congress on Breaches of Unsecured Protected Health Information had several key takeaways as well:

  • OCR received 626 notifications of breaches affecting 500 or more individuals
    • The total number of individuals affected by those breaches was approximately 41.7 million
    • 68% of these breaches were from health care providers, 19% from business associates, 13% from health plans, and <1% from health care clearinghouses
    • 74% of these breaches were reportedly due to hacking/IT incident of electronic equipment or a network service, 19% from unauthorized access or disclosure of records, 4% theft, <1% from a loss of electronic media or paper records containing PHI, and <1% was from improper disposal
    • The PHI was most commonly from network servers (58%), but also from email (22%), paper records (6%), electronic medical records (6%), desktop computer (4%), other portable electronic devices (3%), laptop computer (2%), and other (<1%)
  • The largest breach in 2022 was an incident where hackers utilized ransomware to compromise the servers of a healthcare provider with PHI on them, which affected over 3.3 million individuals
  • Other hacking/IT incidents included the use of malware, phishing, and the posting of PHI to public websites
  • Remedial actions often included:
    • Implementing multi-factor authentication for remote access
    • Revising policies and procedures
    • Training/retraining staff that handle PHI
    • Adopting encryption technologies
    • Imposing sanctions on workforce members who violated policies and procedures regarding the proper handling of PHI
    • Performing a new risk analysis

According to OCR, “There is a continued need for regulated entities to improve compliance with HIPAA Rules. In particular, the Security Rule standards and implementation of specifications of risk analysis, risk management, information system activity review, audit controls, response and reporting, and person or entity authentication were areas identified as needing improvement in 2022 OCR breach investigations.”

If you are not sure where to start, contact PAAS National® (608) 873-1342 for more information on PAAS’ FWA/HIPAA Compliance Program that is easy to set-up, web-based and customized for your pharmacy.

On-demand webinar: Cybersecurity Considerations for Pharmacies

On May 8, 2024 PAAS National® hosted “Cybersecurity Considerations for Pharmacies” webinar.

In a world where threats lurk around every digital corner, safeguarding sensitive information has never been more crucial. Recent events, such as the Change Healthcare cyberattack, serve as stark reminders of the pressing need for robust cybersecurity measures. In pharmacies, where compliance with regulations like HIPAA are of great importance, the stakes are higher than ever.

President of PAAS National®, Trent Thiede, discussed:

  • The importance of cybersecurity in pharmacy
  • The top threats facing healthcare cybersecurity
  • Components, and importance, of a HIPAA Security Risk Analysis

Access the recorded webinar

  • PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Member Portal.
  • PAAS FWA/HIPAA Compliance members also have access to this webinar under Resources upon logging into the Portal.

Distribution Required: Medicare Prescription Drug Coverage and Your Rights (CMS-10147)

When a pharmacy receives a rejection for a claim not being covered by Medicare Part D, the pharmacy must provide the patient with the CMS-10147 form, also known as the Medicare Prescription Drug Coverage and Your Rights. All pharmacies, including mail order, specialty, and LTC, must arrange for this form to be distributed to the patient. The notice instructs enrollees about their right to contact their Part D plan to request a coverage determination, including an exception.

While documentation is not required when distributing the CMS-10147, your pharmacy should have a policy and procedure in place addressing how and when the form is being distributed to patients. PBM field auditors may ask you questions about your process and will possibly want to see a copy of your form to ensure you have the most up-to-date version.

PAAS Tips:

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  • Download the current version of the Medicare Prescription Drug Coverage and Your Rights (Form CMS-10147) at https://www.cms.gov/medicare/appeals-grievances/prescription-drug/plan-sponsor-notices-documents
    • The zip file includes copies of the notice in both English and Spanish, along with accompanying instructions
  • PAAS FWA/HIPAA Compliance Program members should review section 4.5 of their PAAS National® FWA/HIPAA Policy and Procedure manual
  • NCPDP reject code 569 requires distribution of the form and should state “Provide Notice: Medicare Prescription Drug Coverage and Your Rights”
  • The CMS-10147 form must be distributed even if you obtain an alternative therapy or medication
  • Obtaining a prior authorization does not waive the distribution requirement
  • Check with your pharmacy software vendor to see if the program can automatically print a copy of the CMS-10147 when required

Introducing PAAS Cybersecurity Training

In a world where threats lurk around every digital corner, safeguarding sensitive information has never been more crucial. Recent events, such as the Change Healthcare cyberattack, serve as stark reminders of the pressing need for robust cybersecurity measures. In pharmacies, where compliance with regulations like HIPAA are of great importance, the stakes are higher than ever.

PAAS National® is excited to announce the launching of a new training series to FWA/HIPAA Compliance Program members: PAAS Cybersecurity Training. This comprehensive training series, provided at no extra cost, represents a proactive step towards mitigating risks and fostering a culture of security awareness among pharmacy staff.

Comprising of five modules, each tailored to address specific cybersecurity challenges, PAAS’ training empowers employees with knowledge and best practices to hinder potential threats related to:

  1. Network Connected Medical Device Security
  2. Insider Data Loss
  3. Loss or Theft of Equipment and Data
  4. Ransomware
  5. Social Engineering

PAAS’ unique approach to training ensures its content resonates with all pharmacy staff. PAAS’ Cybersecurity Training will have the same look and feel that FWA/HIPAA compliance members are familiar with.

It’s important to recognize that cybersecurity is not a one-size-fits-all endeavor. The dynamic nature of threats necessitates continual adaptation and vigilance, tailored to the unique circumstances of each organization. While our training equips participants with essential knowledge, it does not provide foolproof safeguards.

We encourage FWA/HIPAA Compliance members to complement this training by reviewing their HIPAA Security Risk Analysis regularly, ensuring it remains current and aligned with evolving natural, human and environmental threats.

Are You Prepared for a Spravato® Audit?

Spravato® is a Schedule III controlled substance delivered via intranasal spray, used in conjunction with an oral antidepressant, to address treatment-resistant depression in adults. It is a part of the Risk Evaluation and Mitigation Strategies (REMS) Program, necessitating, dispensing and administration exclusively in a REMS-certified healthcare setting. The FDA mandates specific requirements to mitigate the risks of serious adverse effects stemming from sedation, dissociation, and the potential for abuse and misuse.

Prescribed for weekly or bi-weekly use, a single Spravato® claim can cost you thousands of dollars. PAAS National® has seen audits with full claim recoupments being requested as a result of missing dosage and frequency instructions, as well as incomplete dispensing records. To minimize the risk of a Spravato® claim being recouped during an audit, consider the following PAAS tips:

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  • Review the REMS program requirements for Spravato®
  • Validate the prescription contains:
    • A specific quantity (NCPDP billing unit is 2 EACH or 3 each referring to the number of devices)
      • Each nasal spray device delivers two sprays containing a total of 28 mg of Spravato® (esketamine)
    • How much to administer
    • How often to administer
    • Patient address, prescriber address, phone number and DEA # need to be present on a controlled prescription
  • Neither the prescriber nor the pharmacy should use a default SIG – it MUST have a specific dose and frequency
  • The days’ supply should be based on the treatment regimen
  • Spravato® is intended for the patient to administer under the supervision of a healthcare professional
  • Ensure proper documentation of dispensing to a certified healthcare setting occurs. The delivery log MUST contain the following elements:
    • Patient name, dose, number of devices dispensed and the date of dispensing
    • Name, address and phone number of the prescriber’s office
    • Printed name, title, signature, and date of the representative receiving the order
  • See our November 2019 Newsline article, Spravato® – Watch the Billing! for proper billing information, including package size and billing units

Why Do You Need a HIPAA Risk Analysis? Ask Change Healthcare…

If you have not been affected by the Change Healthcare cyberattack, you have no doubt heard about the sinister actions of the ALPHV Blackcat ransomware gang and the resulting chaos from their February data breach they caused. At the time of this article, the details of the Change Healthcare attack are still widely unknown to the public but two things are certain… (1) the attack should serve as a cautionary tale to all entities handling electronic protected health information (ePHI) and (2) it is a perfect reminder that a HIPAA Risk Analysis is a critical component to the security of your sensitive data.

A Risk Analysis is an accurate and thorough assessment of the potential threats, vulnerabilities and the associated risks to the confidentiality, integrity and availability of ePHI. According to the Guidance on Risk Analysis webpage from the U.S. Department of Health and Human Services (HHS), “All e-PHI created, received, maintained or transmitted by an organization is subject to the Security Rule. The Security Rule requires entities to evaluate risks and vulnerabilities in their environments and to implement reasonable and appropriate security measures to protect against reasonably anticipated threats or hazards to the security or integrity of e-PHI. Risk analysis is the first step in that process.”

The Office for Civil Rights (OCR) is responsible for enforcing federal HIPAA Rules and investigating complaints and violations. In many prior OCR investigations, pharmacies and other healthcare entities settling potential HIPAA violations are often cited with failure to perform an accurate and thorough risk analysis. Since HHS considers a risk analysis to be “the first step” in complying with the HIPAA Security Rule, OCR anticipates that a failure to complete the risk analysis will undoubtedly lead to other insufficiencies and a probable hefty monetary settlement.

As stated in the March 5, 2024 press release from HHS regarding the Change Healthcare cyberattack, “This incident is a reminder of the interconnectedness of the domestic health care ecosystem and of the urgency of strengthening cybersecurity resiliency across the ecosystem.” Take steps now to evaluate and strengthen the security and integrity of your ePHI!

PAAS Tips:

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  • A new risk analysis should be conducted at least annually, or whenever there is a significant change to the information systems or security policies and procedures
    • Deploying new computer equipment (i.e., anything that houses ePHI) or installing a new gate are situations that require updates to your risk analysis
  • Keep all documentation related to HIPAA for a minimum of six years after the last effective date
  • For more information from HHS regarding the Change Healthcare cyberattack and the coordinated efforts and flexibilities in place, refer to their March 5, 2024 press release
  • Check out the newly released HHS voluntary performance goals to enhance cybersecurity in the health sector and their new gateway website developed to increase accessibility and awareness of cybersecurity information and resources from HHS and other federal agencies
  • Feeling overwhelmed? Don’t know where to start? If your pharmacy does not currently have the PAAS FWA & HIPAA Compliance Program, we suggest scheduling a services overview to obtain additional information. The compliance program includes a custom HIPAA Risk Analysis. It is in your best interest to identify threats, and corresponding vulnerabilities associated with those threats, so you can develop reasonable safeguards, where practicable.