Every day, pharmacies and their hardworking staff safeguard patients’ Protected Health Information (PHI), but breaches still occur. The June 2023 Health and Human Services Office for Civil Rights (OCR) Cybersecurity Newsletter focused on providing an insight into cybersecurity authentication and tips for building a more robust “wall” for malicious actors to encounter before a breach could occur. The OCR newsletter indicated that according to a 2023 Data Breach Investigations Report, “86% of [cyber] attacks to access an organization’s Internet-facing systems (e.g., web servers, email servers) used stolen or compromised credentials” and “robust authentication serves as the first line of defense against malicious intrusions and attacks”.
As mentioned in the OCR newsletter, the National Institute of Standards and Technology’s Digital Identity Guidelines believes that “historically, three factors form the cornerstones of authentication:
- Something you know (e.g., password, personal identification number (PIN))
- Something you have (e.g., smart ID card, security token)
- Something you are (e.g., fingerprint, facial recognition, other biometric data)”
Multi-factor authentication is a common method for ensuring the person gaining access to a system is, in fact, who they say they are. It would require one element from two different bullets listed above, such as a password plus a security token. The Cybersecurity Newsletter states that “Cyber-attacks often begin with a compromised password that is used to gain initial access to an electronic information system.” If a password is compromised through a successful phishing attempt, the second element (e.g., security token) may be enough to block unauthorized entry long enough for the Security Officer to perform an Information Systems Activity Review and identify the unusual activity and intervene.
Safeguarding PHI and being compliant with the HIPAA Security Rule is required for any entity handling PHI. The Security Rule was designed to be flexible, allowing providers with varying scopes, sizes and resources to be compliant. Whether your pharmacy has been around for 30 years or 30 days, a thorough evaluation of your HIPAA program should be done at least annually. The beauty of the PAAS National® Fraud, Waste & Abuse (FWA) and HIPAA Compliance Program, is that it mirrors the flexibility of the HIPAA Security Rule and is anything BUT a cookie-cutter program. Pharmacies perform a risk analysis upon enrolling in the program and answer questions which allows us to customize a compliance policy and procedure manual specific to your pharmacy. PAAS Analysts are always happy to discuss how the PAAS FWA/HIPAA Compliance Program is built to help you address federal regulations. Call (608) 873-1342 or visit PAASNational.com to see how you can become an FWA/HIPAA Compliance member today.
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- Current FWA/HIPAA Compliance members can
- Review sections 11.3.4 Information System Activity Review, 11.4 Workforce Security and 11.14 Access Control of the Policy and Procedure manual for more information
- See Appendix B for the Information System Activity Review Log
- Utilize the Employee Request for Access form in Appendix B to record the level of access and any keys or identification badges each employee possesses in order to perform their job duties, AND to record when the access is terminated, and keys/badges are returned
- Provide each employee with their own unique log-in credentials and ensure their HIPAA training discusses the importance of safeguarding their passwords and all keys/security badges
Standard Written Order and Medicare Part B Audit Risks – New Guidance
If you are a Medicare Part B provider, then you know how cumbersome a Medicare Part B audit can be. For most Medicare Part B audits, a pharmacy would be required to provide a valid Standard Written Order (SWO), medical records to support the diagnosis and continued need of the item, proof of delivery, and proof of refill request if mailing or delivering supplies.
This article is going to focus on the SWO. In January of 2020, CMS finalized Rule 1713 which created a unified order for all DMEPOS items. While this new SWO was designed to reduce the burden on both suppliers and providers, audit results would prove otherwise. The required elements of an SWO are:
Below are the three most common SWO discrepancies PAAS National® sees on audit results and our guidance to help prevent these discrepancies from occurring.
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Alleged Inattentiveness to Details Costs Pharmacy $70,000
The DEA was established as a federal agency to regulate drug laws and to prevent misuse and/or diversion of both controlled substance and non-controlled medications. Their effort to prevent misuse and diversion of controlled substance medications starts with pharmacies filling prescriptions based on valid hardcopies. As was the case for CVS Pharmacies in New Hampshire, red flags that the federal government believes would have alerted a pharmacist of a fraudulent prescription were ignored, resulting in an alleged 41 fraudulent prescriptions being filled for Adderall®, Ritalin®, and Xanax ®. In order to resolve the allegations, CVS agreed to pay $70,000.
This civil case against CVS came as a result of two criminal investigations into individuals who utilized a variety of CVS Pharmacies around New Hampshire to fill fraudulent prescriptions. This speaks to the importance of ensuring the prescriptions that you are filling at your pharmacies are valid and written for a valid medical purpose by a provider within their usual scope of practice.
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Considerations With Ozempic 0.25 Weekly
PAAS National® analysts receive many questions on Ozempic® relating to concerns about off label use; however, we also receive questions about what days’ supply to submit on claims – particularly for initiation dosing.
Section 2.1 of the manufacturer’s product label (available on DailyMed) lists the recommended dosage schedule based on clinical trials and includes the following titration schedule:
What happens if the prescriber wants a patient to stay on the 0.25 mg dose for longer than 4 weeks? What if the prescription simply states “inject 0.25 mg weekly”? What days’ supply should the pharmacy transmit?
If you receive a new Ozempic® prescription with instructions of 0.25 mg weekly, we suggest that pharmacies follow-up with prescribers to discuss the manufacturer recommended dosage titration and confirm if patients will be titrating the dose to 0.5 mg or 1 mg weekly, and when. If the prescriber’s office confirms that the patient should stay on the 0.25 mg weekly dose for eight weeks, then the pharmacy should submit the claim as a 56-day supply (if possible) and provide the patient with additional pen needles to accommodate all needed doses. As a reminder, pharmacies may be required to bill a claim as a 30-day supply due to plan limits – in these situations, make sure to follow the Can You Bill It As 30 Days? process to ensure that you do not refill early.
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Electronic Clinical Notes: Are They Required?
There has been some discussion in pharmacy circles about clinical notes and whether PBMs are requiring them to be electronically annotated (or if hand-written clinical notes will continue to suffice).
First, DEA rule 21 CFR 1311.200(f) states that pharmacists must make and retain annotations electronically when filling an electronic prescription.
Second, be aware that state laws may require electronic annotations. For example, New York controlled substance rules mirror the DEA language when it comes to electronic prescriptions and annotations.
Third, while PBMs may not explicitly require electronic annotations, not having date and time stamped notes in your pharmacy software may be detrimental for audit appeals. Many PBMs are giving preference, or requiring, electronic date and time stamped clinical notes to appeal certain discrepancies successfully. With a date/time stamp, the detail provides validation to the PBM that they existed at the time of dispensing.
Examples:
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Desk Audits for Worker’s Compensation Claims
PAAS National® analysts have recently seen an increase in desk audits for worker’s compensation claims, mostly performed by Script Care. There has been a high rate of fraud with worker’s compensation in the past and these claims are subject to more scrutiny.
Many states have additional laws specific to worker’s compensation and auditors have often cited prescriptions as “invalid” if prescriptions did not conform to these specific laws.
A few common audit discrepancies include:
Upon first receiving an audit contact PAAS (608) 873-1342 so that an analyst can assist you from the start of the audit for the best results.
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Auditors Crack Down on Pharmacies That Bypass Plan Limits
PAAS National® analysts want to warn pharmacies about an uptick in PBMs flagging prescriptions for bypassing plan limit rejects. These prescriptions are being marked as discrepant and face full recoupment. Share this information with your staff and ensure that claims are not unintentionally being put at risk for audit/recoupment.
When pharmacies receive a reject of plan limit or exceeds maximum daily dose, pharmacy staff must follow the plan guidelines to submit the claim appropriately. The plan sending this rejection is telling the pharmacy that the dosage is not covered without additional requirements. This could mean prior authorization, switching to a different dose, or changing to another medication.
Pharmacies that manipulate the days’ supply to bypass the rejection are putting those claims at risk of recoupment. PBMs can easily track when pharmacies run a claim, receive a reject, and immediately rebill for the same quantity but different days’ supply. This raises a red flag that the plan reject was likely not adhered to appropriately – low hanging fruit for PBM auditors.
Reducing the quantity and/or split billing prescriptions can also be an audit risk. If a reduced quantity is submitted to bypass the plan limit (e.g., to get under a dollar threshold), the claim is still in jeopardy of being recouped. Beyond circumventing a plan limit, the payor may argue it increased costs through additional refills, dispensing fees, and patient copays. One patient complaint to their plan could lead to big trouble for network pharmacies.
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Nearly 90% of Cyber Breaches are Caused by…
Every day, pharmacies and their hardworking staff safeguard patients’ Protected Health Information (PHI), but breaches still occur. The June 2023 Health and Human Services Office for Civil Rights (OCR) Cybersecurity Newsletter focused on providing an insight into cybersecurity authentication and tips for building a more robust “wall” for malicious actors to encounter before a breach could occur. The OCR newsletter indicated that according to a 2023 Data Breach Investigations Report, “86% of [cyber] attacks to access an organization’s Internet-facing systems (e.g., web servers, email servers) used stolen or compromised credentials” and “robust authentication serves as the first line of defense against malicious intrusions and attacks”.
As mentioned in the OCR newsletter, the National Institute of Standards and Technology’s Digital Identity Guidelines believes that “historically, three factors form the cornerstones of authentication:
Multi-factor authentication is a common method for ensuring the person gaining access to a system is, in fact, who they say they are. It would require one element from two different bullets listed above, such as a password plus a security token. The Cybersecurity Newsletter states that “Cyber-attacks often begin with a compromised password that is used to gain initial access to an electronic information system.” If a password is compromised through a successful phishing attempt, the second element (e.g., security token) may be enough to block unauthorized entry long enough for the Security Officer to perform an Information Systems Activity Review and identify the unusual activity and intervene.
Safeguarding PHI and being compliant with the HIPAA Security Rule is required for any entity handling PHI. The Security Rule was designed to be flexible, allowing providers with varying scopes, sizes and resources to be compliant. Whether your pharmacy has been around for 30 years or 30 days, a thorough evaluation of your HIPAA program should be done at least annually. The beauty of the PAAS National® Fraud, Waste & Abuse (FWA) and HIPAA Compliance Program, is that it mirrors the flexibility of the HIPAA Security Rule and is anything BUT a cookie-cutter program. Pharmacies perform a risk analysis upon enrolling in the program and answer questions which allows us to customize a compliance policy and procedure manual specific to your pharmacy. PAAS Analysts are always happy to discuss how the PAAS FWA/HIPAA Compliance Program is built to help you address federal regulations. Call (608) 873-1342 or visit PAASNational.com to see how you can become an FWA/HIPAA Compliance member today.
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Invoice Audits Are on the Rise – Are You Prepared for Success?
Most pharmacies have grown accustomed to desk audits and providing copies of prescriptions, signature logs, and even copay collection records to PBMs upon request. Additionally, many pharmacies can recount their most recent experience with an onsite auditor visiting their pharmacy and the numerous questions related to operations, policies & procedures, and credentialing. However, not as many pharmacies have experienced an invoice audit – the stakes are higher and honest mistakes can lead to very expensive lessons in the process.
PAAS National® analysts have helped our members navigate countless invoice audits. Our analyst team is here to assist you through the audit process from start to finish and that includes getting things done correctly long before the audit ever comes your way. Follow the tips below to have the most success.
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Billing Test Claims? It Can Cost You!
We have all been there – a prescriber calls the pharmacy to find out which prescription from a therapeutic category will be the most cost-effective for the patient. Without access to a plan formulary, the only way you can easily do this for the prescriber is to bill claims to the insurance one by one. Not only is this a time-consuming practice, it can also be costly because “test claims” are prohibited by most third-party payers.
Why would something that seems beneficial to a patient be prohibited? Unfortunately, test claims have been used by bad actors to maximize reimbursement from PBMs, often to the detriment of the plan, and even the patient. In a real-world example, a Florida pharmacy owner was recently convicted on two counts of soliciting and receiving illegal health care kickbacks and three counts of offering and paying illegal health care kickbacks. He was caught when billing test claims to maximize his reimbursement, then paying millions in kickbacks based on a percentage of the reimbursement to those willing to prescribe the most expensive drugs. He is currently awaiting sentencing which could include a maximum of 10 years in prison for each kickback count.
Another reason test claims are prohibited is because a pharmacy may forget to reverse a claim after testing it and receive payment for a prescription that does not exist, was not prescribed, purchased, or dispensed. This can financially impact the plan and can lead to mistakes and confusion for the patient regarding deductibles and coinsurance.
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MATE Training for Buprenorphine Prescribers
Historically, buprenorphine prescriptions with an indication of opioid dependence were an easy recoupment when an X-DEA number wasn’t included on the hardcopy. However, as discussed in our February 2023 Newsline article, XDEA Numbers Have Been NiXed…but Not the Training, X-DEA numbers are no longer required due to the Mainstreaming Addiction Treatment (MAT) Act, found in Section 1262 of the “Consolidated Appropriations Act of 2023”. Instead, there are now training requirements for DEA registrants before being able to prescribe buprenorphine prescriptions. Beginning on June 27, 2023, Section 1263 of the “Consolidated Appropriations Act of 2023”, the Medication Access and Training Expansion (MATE) Act, requires all new or renewing DEA registrants to have met at least one of the following requirements when submitting their DEA registration application:
How does this relate to your pharmacy?
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