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:
- Network Connected Medical Device Security
- Insider Data Loss
- Loss or Theft of Equipment and Data
- Ransomware
- 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.
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 …
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:
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.
PAAS Tips:
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:
The 2022 Annual Report to Congress on Breaches of Unsecured Protected Health Information had several key takeaways as well:
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:
Access the recorded webinar
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:
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:
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:
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:
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:
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:
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!