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.

LIVE Webinar: Cybersecurity Considerations for Pharmacies

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.

Join President of PAAS National®, Trent Thiede, on Wednesday, May 8, 2024 from 2:00-2:45 pm CT as he discusses:

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

We will allow for some Q&A at the end of the webinar. If you would like to submit questions prior to the webinar, please click here.

PAAS Audit Assistance and FWA/HIPAA Compliance Program members will have access to the webinar recording following the LIVE event. 

2023 Health and Human Services Language Access Plan Released: New Plan, Same Goal

Equal access to health care is far from a new topic, dating back to Title VI of the Civil Rights Act of 1964. In recent years, there has been a noticeable increase in enforcement. In November 2021, Rite Aid Corporation reached a settlement with the U.S. Attorney’s Office due to the company’s COVID-19 registration portal not being compatible with screen reader software used by some patients with disabilities and the inability to utilize the tab key when filling out the consent form for those who have issues using a mouse. Furthermore, in the July 2023 Newsline article HHS Reports Successes in Access to Meaningful Language Assistance Services, the Office for Civil Rights (OCR) relaunched the Language Access Steering Committee in October of 2022. The committee was tasked with implementing goals from the 2022 HHS Equity Plan, in part aiming to ease access to federal programs by providing language tools in an individual’s preferred language. In addition, the position of HHS Language Access Coordinator was created. They were tasked in part with updating and revising HHS’ 2013 Language Access Plan. In a November 2023 press release, HHS announced the Language Access Steering Committee issued the which prioritizes inclusivity of communication within services to the public and is applicable across every HHS agency, including the Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), and Office for Civil Rights (OCR).

The following are components of the 2023 Language Access Plan that is pertinent to the practice of pharmacy:

  • Each HHS agency will have an annual budget assessment that will be used to develop a budget request to enhance the agency’s ability to assist the LEP patient population
  • “Each HHS agency shall ensure access to timely, quality language assistance services (LAS) for individuals with limited English proficiency”
  • There is an increased focus on HHS agencies taking steps to ensure appropriate language assistance services, including face-to-face, virtual, or telephonic encounters, are being provided free of charge
  • There is a push to decrease the amount of family, community members, and/or children from being recruited as a translator in medical situations as research has shown negative health consequences. In its place, “qualified interpreters” who are able to interpret medical terms and adhere to patient ethics and confidentiality requirements
  • HHS agencies are to continually collect and share metrics including but not limited to identifying the primary channels of contact with LEP community members and “maintaining an inventory of who attended language access training”
  • “HHS agencies must take reasonable steps to ensure meaningful access to their programs…by persons with LEP, including notifying persons with LEP who are current or potential customers about the availability of language assistance at no cost”
  • The Language Access Plan acknowledges “health care and human services partners can provide agencies with qualitative and first-hand data on the needs of their current and potential individuals with LEP”

As we witness federal agencies increasing the effort put forth in battling health inequity, pharmacies will prove to be a key component in making a difference in the fight. Training staff to help provide equitable access to care, and potentially grow your business, is the first step. Inquire about PAAS’ Cultural Competency Training and Linguistically Appropriate Services and the PAAS Care ModelTM today!

New COVID-19 Booster Dose & The Final Frontier of the PREP Act

On February 28th, the CDC endorsed an additional updated 2023-2024 COVID-19 vaccine dose for adults 65 years or older due to the increased risk of serious COVID-19 outcomes in that patient population. The approval of an additional dose brings the question of what submission clarification code (SCC) may be required. Coinciding with the transition from US government supplied COVID-19 (EUA) vaccines, commercially available vaccines no longer required an SCC due to their approval as a single-dose vaccine. Now that an additional dose has been approved, it remains to be determined if payors will want an SCC. Many payors (e.g., OptumRx and Medi-Cal) still have the SCC requirements for the original series in their Provider Manuals. In addition, the American Medical Association (AMA), the entity that supplies CPT codes for medically based services, has deactivated CPT codes associated with specific COVID-19 dose vaccines (i.e., First, Second, Third, Booster).

As a reminder, the Public Readiness and Emergency Preparedness (PREP Act) was amended by Secretary Becerra for the eleventh time on May 12, 2023. As stated on the Administration for Strategic Preparedness & Response’s (ASPR) PREP Act Questions & Answers webpage, the amended PREP Act “authorize[s] pharmacists to continue to administer COVID-19 and seasonal influenza vaccines to individuals aged three and above and order and administer COVID-19 tests in accordance with an FDA license, approval, or authorization through December 31, 2024.” Ultimately, this means that under the changes made in the Eleventh Amendment of the PREP Act, there will be liability protections in place for COVID-19 vaccines and tests, along with seasonal influenza vaccines through December 31, 2024.

PAAS Tips:

  • The CDC has a useful website to determine what vaccination and dose a particular patient needs based on their vaccination history
  • Recall the billing units for COVID-19 vaccines are in mL and the correct days’ supply is 1