Pharmacies receiving a faxed document from another pharmacy for a transfer must ensure all transfer requirements are included. If any requirements are missing (e.g., including the word “transfer” in some cases), the pharmacy must verify and add the information. Relying on another pharmacy to include all transfer requirements is extremely risky and could result in audit recoupments. Be aware, some states require transferred prescriptions be “reduced to writing.” PBMs like Humana have recouped claims in these states when a faxed form was used.
When PBMs like Humana, OptumRx, and Elixir flag a transferred prescription discrepant, they not only go after that claim, but all the refills under that prescription as well. Very quickly a small error can result in thousands of dollars facing recoupment.
Another way transferred prescriptions present audit risk is the invalid entry of the written date. If the receiving pharmacy fails to enter the actual written date of the prescription, the pharmacy could potentially refill past expiration. Make sure your staff is aware of the importance of entering accurate dates. PBMs are also flagging transferred insulin prescriptions if the quantity does not indicate a unit of measure (i.e., mL, pens, boxes or units).
PAAS Tips:
- Check your state’s Board of Pharmacy transfer requirements and have printed for reference
- Educate all staff on your state’s prescription transfer requirements
- Pre-printed prescription pads with all your state’s transfer requirements can be very beneficial
- Pharmacies using an internal transfer screen to capture the requirements must include this during an audit
- See the Newsline’s Self-Audit Series #6 for monitoring your transfers internally
Humana Compliance Requirements – Training and Exclusion Checks Are Not Enough
PAAS National® analysts have received several questions regarding Humana’s 2022 Notice of Program Requirements. Humana’s Compliance Policy for Contracted Healthcare Providers explicitly states pharmacies must have a compliance program that meets the seven elements outline by CMS, including written policies, procedures and standards of conduct. Per the 2022 Pharmacy Compliance Education and Training Requirements FAQs: “Humana reserves the right to request documentation (e.g., policies and tracking records) confirming that your organization has an effective compliance program that meets the requirements outlined in the Compliance Policy and Standards of Conduct.”
PAAS’ Fraud, Waste & Abuse and HIPAA Compliance program keeps members compliant beyond training and exclusion checking. Since 2009, the program was designed to meet these CMS requirements, with the full support of our expert staff – pharmacists just like you, with years of experience helping community pharmacies with FWA and HIPAA compliance.
If you aren’t a member of FWA/HIPAA and are interested in saving $126 on your membership, please contact PAAS at (608) 873-1342 to become an Elite member.
PAAS Tips:
Self-Audit Series #13: Diabetic Test Strips
The 2020 National Diabetes Statistics Report, analyzed data through 2018 and found that there are over 34 million Americans with diabetes (approximately 1 in 10 Americans). Additionally, there are 88 million Americans with prediabetes (approximately 1 in 4 Americans). Based off this data, there are more than 120 million people in the United States that are living with diabetes or prediabetes. Due to the high volume of claims for diabetic test strips, they continue to receive significant attention during third-party audits. Follow the tips below to be prepared if you get an audit.
Purchasing Requirements
Billing
Additional Newsline Article References for Self-Audit
Are You Prepared to Prove TIRF REMS Program Compliance?
The purpose of the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Program is “to mitigate the misuse, abuse, addiction, overdose, and serious complications due to medication errors with the use of TIRF medicines.” If your pharmacy dispenses Actiq®, Fentora®, Subsys®, or other medications which fall under the TIRF program, now is a good time to evaluate your compliance with all TIRF REMS requirements. The program has strict standards for all stakeholders involved with TIRF products including program administrators, wholesalers, prescribers, pharmacies and patients. Annually, the program administrators must audit all certified outpatient pharmacies who ordered at least one shipment of a TIRF medication in the preceding 12 months, up to 400 pharmacies.
PAAS National® analysts have seen audits recently conducted by Compliance Architects®, a company which offers many services including FDA risk management and compliance consulting. The audits have consisted of a short online survey followed by a self-scheduled virtual meeting. During the audit process, pharmacies are expected to share copies of various program-related documents such as:
A key factor to successfully completing the audit is being able to provide robust policies and procedures which meet all program requirements. Whether you’re reviewing your current policies and procedures, or find yourself without this key compliance element, reviewing the Pharmacy Education document found online under the Pharmacy page of the TIRF REMS Access Program website is a good starting point. Mirroring each section from the Pharmacy Education document in your own policy and procedure can help ensure all compliance elements are captured.
If your pharmacy is found to be non-compliant, the type and severity of the offense determines the reprimand (which may consist of a corrective and preventative action plan, continued monitoring for compliance or potentially deactivation from the TIRF REMS program). A copy of the TIRF REMS Non-Compliance Protocol can be found on the Access Program website.
PAAS Tips:
COVID-19 Oral Therapeutics Antiviral Billing Guidance
Two oral products have received Emergency Use Authorization for the treatment of COVID-19 infection – PaxlovidTM (Pfizer) and Molnupiravir (Merck). Both products are a 5-day course and are only authorized for dispensing pursuant to a patient-specific prescription or delegated collaborative practice agreement. Unfortunately, the FDA did not authorize independent prescribing by pharmacists.
Like the COVID-19 vaccines, oral therapeutics are purchased by the federal/state government and distributed to pharmacies at no cost. However, oral therapeutics are in very limited supply and only available to pharmacies that are part of the Federal Retail Pharmacy Program or directly from state health departments. Also, similar to the COVID-19 vaccine, oral therapeutics must be dispensed with no cost to the patient.
Billing
20*
2 tablets BID x 5 days (renal)*
*Renal dose adjustment for eGFR <60 but ≥ 30 mL/min
Reimbursement
While Medicare has covered COVID-19 vaccines under the Part B (medical) benefit, the oral therapeutics are a Part D (pharmacy) covered benefit. Medicare has not required plan sponsors to pay a dispensing fee, but instead “encourages” a dispensing fee. Commercial payers and Medicaid programs are expected to cover oral therapeutics under the pharmacy benefit and dispensing fee reimbursement may vary. The government has not required payers to cover oral products at all pharmacies and normal in-network limitations may apply.
Thus far, it appears that Part D Plans/PBMs are NOT providing reasonable reimbursement to pharmacies as evidenced by NCPA’s letter to CMS on January 18, 2022.
PAAS Tips:
New OTC COVID-19 Resources for Community Pharmacies
On February 2, PAAS National® announced new COVID-19 resources for PAAS Audit Assistance members to aid in billing commercial third-parties for OTC COVID-19 tests.
Members can access these tools, day supply charts, on demand webinars and more by logging into the PAAS Member Portal.
Not a member but interested in accessing COVID-19 tools available to you, click here. For member only tools call (608) 873-1342 to join today!
Caremark® Expands “Aberrant” Language & Restricts Bulk Purchases
As mentioned in PAAS’ December 2021 Newsline article about PBM provider manual updates, Caremark® traditionally mails a paper hardcopy of their full provider manual on even years, and only amendments on odd years. With 2022 being an even year, contracted pharmacies should have received a full paper copy of the 2022 provider manual.
In the 2020 Caremark® Provider Manual, section 3.02.03 was dedicated to explaining a provider’s obligation to not dispense aberrant quantities and volumes. Pharmacies are likely aware of the aberrant products list and Caremark’s arbitrary threshold of 25% (by dollar amount or number of Caremark® claims) which pharmacies were not allowed to exceed. Found within the same section in the 2022 manual, “Aberrant Quantities and Volumes” has been expanded and retitled to “Aberrant Practices and Trends”. The updated section title encompasses the five aberrant practices and trends for which Caremark® providers must not engage. In regards to the aberrant quantities and volume restrictions, Caremark® added language which goes beyond billing.
Though the language in the manual was recently added, Caremark® has pursued these additional “aberrant practices” in the past. PAAS National® analysts have assisted pharmacies with audits which targeted claims billed for higher-cost medications (medications which had less expensive, more widely prescribed, equivalents from within the same therapeutic class). Caremark® has targeted pharmacies suspected of “fishing” for medications with the highest possible reimbursement rate, a practice which may easily trigger an audit due to the rapid adjudication and subsequent reversal of various medications within the same therapeutic class. These practices are formally listed as activities which may lead to claim chargebacks, Caremark® enforced remedies, and even contract termination.
Another section to be familiar with is section 8.05 which discusses bulk purchases. Anyone who has been through an invoice audit knows the importance of having enough purchased quantity (quantity “in”) to cover all the claims billed (quantity “out”) during the specified audit date range. Invoices from outside the audit date range may or may not be accepted depending on how far outside the audited date range the additional invoices are from and depending on the PBM. The 2022 Caremark® Provider Manual states that invoices from the audit date range, plus an additional 30 days prior to the listed range, must have sufficient product to cover all claims billed within the specified range. Caremark® states they will not count purchases from more than 30 days outside the audit date range toward product “in” unless the pharmacy previously notified Caremark® of these “bulk purchases” first by sending written request via mail within seven days prior to the purchase and Caremark® responds with a written approval. The postal address to which these requests must be sent can be found within section 8.05. The ridiculous process and audacity for such an anticompetitive policy is not lost on PAAS. We suspect there will be legal challenges to this language in the future. In the meantime, be cognizant of the requirement and consider flooding Caremark with “bulk purchase” requests.
PAAS Tips:
West Virginia Community Pharmacists: Are you prepared?
There is a new Health Care Fraud Strike Force focused on uncovering fraud, waste and abuse in West Virginia.
The January 18th Department of Justice press release announced the launching of the Mountaineer Health Care Fraud Strike Force. At their first gathering they discussed fraudulent billing patterns and identified new targets. They plan to engage providers and insurers to recognize and report health care fraud.
Don’t miss your opportunity to be proactive and stay informed with PAAS Audit Assistance and the best FWA/HIPAA compliance program available, customized for community pharmacies.
Avoid being caught off-guard — one pharmacy recently paid $196,929 for self-reporting an employee that should have been excluded from participation!
“A pharmacy without the compliance program does not have their bases covered and required work finished. I can sleep at night knowing this program keeps me protected and on task.”
Transfer Prescriptions Continue to Be Targeted
Transferred prescriptions remain a common audit target, and pharmacies are facing recoupments due to missing information. Without having all required elements set in place by your state’s Board of Pharmacy, these claims are at risk of full recoupment by PBMs. Transferred prescriptions are easily identified and audited by the PBM due to the origin code.
Pharmacies receiving a faxed document from another pharmacy for a transfer must ensure all transfer requirements are included. If any requirements are missing (e.g., including the word “transfer” in some cases), the pharmacy must verify and add the information. Relying on another pharmacy to include all transfer requirements is extremely risky and could result in audit recoupments. Be aware, some states require transferred prescriptions be “reduced to writing.” PBMs like Humana have recouped claims in these states when a faxed form was used.
When PBMs like Humana, OptumRx, and Elixir flag a transferred prescription discrepant, they not only go after that claim, but all the refills under that prescription as well. Very quickly a small error can result in thousands of dollars facing recoupment.
Another way transferred prescriptions present audit risk is the invalid entry of the written date. If the receiving pharmacy fails to enter the actual written date of the prescription, the pharmacy could potentially refill past expiration. Make sure your staff is aware of the importance of entering accurate dates. PBMs are also flagging transferred insulin prescriptions if the quantity does not indicate a unit of measure (i.e., mL, pens, boxes or units).
PAAS Tips:
Self-Audit Series #12: Invoice Audits
PBMs have dramatically increased the number of invoice audits conducted and some pharmacies continue to be at risk for significant financial recoupments and contract terminations. It is not uncommon for invoice audit results to exceed six figures. To reduce the risk of your pharmacy having problems during a PBM invoice audit, consider performing a mock audit on your practice. The PBM is simply comparing the “ins” and “outs” of your pharmacy inventory for a specific period. If your “ins” are less than your “outs” for the PBM auditing, they conclude you have a shortage and will initiate recoupment. The “ins” are your acquisitions, or purchases, from wholesalers, manufacturers, trade shows or other pharmacies (note: there is no accounting for inventory on-hand). The “outs” are the claims that you billed to the PBM conducting the audit as well as any returns. The PBM already has the billed claims for the defined window, so when they initiate the invoice audit, they’re typically just in need of your purchasing history. Several PBMs, including OptumRx®, Elixir®, and Express Scripts® may even require the pharmacy to submit a full dispensing history for further reconciliation. Follow the tips below to reduce the risk of your pharmacy having problems during a PBM invoice audit.
PAAS Tips:
Common Claim Denials for Medicare Part B
In the PAAS National® August 2019 Newsline article, Medicare Part B/DMEPOS Audits – Who are All These Contractors?, we explained that Medicare and Medicaid use a number of audit contractors to perform medical review audits on pharmacies. The three main contractors PAAS sees carrying out these audits are: DME Medicare Administrative Contractors (MACs), Recovery Audit Contractors (RACs) and Supplemental Medical Review Contractors (SMRCs).
Many of the denied claims are due to not meeting medical necessity, frequency limitations, lacking supporting medical records and even basic coding mistakes. See PAAS Tips for links on billing specific DMEPOS items and required documentation for Medicare Part B claims.
PAAS Tips: