by Tracie Acosta, CPh, Published March 11, 2022 by Pharmacy Times
In recent years, the auditing process has evolved into a full-blown investigation, often requiring pharmacies to submit hundreds of pages of documentation
Compliance audits launched by pharmacy benefit managers (PBMs) have long been a cause of frustration for pharmacies, especially independent community pharmacies with limited manpower and resources compared to large chains. This challenge has only magnified since the onset of the COVID-19 pandemic in early 2020.
PBMs have adapted their practices by switching to virtual audits, leaving them with the ability to review more claims than ever before. As a result, pharmacies that are juggling the chaos of audit documentation, vaccine distribution, prescription refills, and a plethora of other responsibilities stand to lose. It’s no wonder that the average audit in 2020 cost pharmacies $23,978, which is 35% more than the annual average over the previous 5 years, according to the pharmacy audit assistance service, PAAS National.
Traditionally, a PBM would simply check that the pharmacy received a valid prescription, dispensed the proper amount according to the prescription, and submitted a claim for the correct amount dispensed. But in recent years, the auditing process has evolved into a full-blown investigation, often requiring pharmacies to submit hundreds of pages of documentation—and auditors can even use minor clerical errors as excuses to deny payments.
As pharmacy compliance audits grow in sophistication, it’s up to pharmacies to remain diligent in monitoring their operations, especially the following aspects of their operations in 2022. Here are some tips for getting ahead of and managing audits in the year ahead.
Continue to read the full article here.
Billing OTC COVID-19 Tests Brings New Struggles and Opportunities
In addition to the free COVID-19 testing sites nationwide and COVID-19 tests that can be acquired through the federally-established website COVIDTests.gov, private health insurances are required to cover at-home rapid COVID-19 tests at no cost to consumers. As of January 15, 2022, pharmacies are capable of billing up to eight at-home COVID-19 tests per covered individual per month. Along with this opportunity brings about new struggles surrounding how to properly bill an individual’s insurance. Utilizing PBM communications, and guidance published surrounding at-home COVID-19 test billing, PAAS National® created additional resources to assist in proper billing and documentation requirements that PBMs may require.
PAAS recommends pharmacies have retrievable documentation when billing at-home COVID-19 tests through your pharmacy system. In addition, PBMs such as Prime Therapeutics and Express Scripts have communicated their billing requirements for at-home COVID-19 tests. PAAS developed the Commercially Insured Patient Request and Attestation for OTC COVID-19 Test Billing document to assist with future audits pertaining to billing a patient’s insurance for the testing supplies.
The Commercially Insured OTC COVID-19 Tests Frequently Asked Questions (FAQ) document answers many questions pharmacies may have surrounding how to go about billing the at-home tests, such as if a prescription is needed to bill for an OTC COVID-19 test or who the prescriber will be if a pharmacy initiates a prescription vs. when a pharmacy does not initiate a prescription. The FAQ document also includes a list of known authorized tests which are covered under the OTC Emergency Use Authorization (EUA), albeit not a fully comprehensive list. As stated by NCPA on February 1, 2022, there have been type 1 consumer recalls on at-home tests falsely alleging to be authorized by the FDA. When placing an order for OTC COVID-19 tests, properly vet the distributor and the product to ensure the at-home tests being ordered are an authorized FDA test.
All PAAS produced COVID-19 materials can now be conveniently located under the COVID-19 Resources page on the PAAS Portal. As additional information is released pertaining to at-home COVID test billing practices and other COVID-related topics, periodically visit the portal for the most up-to-date resources.
Four Tips for Navigating Pharmacy Compliance Audits in 2022
by Tracie Acosta, CPh, Published March 11, 2022 by Pharmacy Times
In recent years, the auditing process has evolved into a full-blown investigation, often requiring pharmacies to submit hundreds of pages of documentation
Compliance audits launched by pharmacy benefit managers (PBMs) have long been a cause of frustration for pharmacies, especially independent community pharmacies with limited manpower and resources compared to large chains. This challenge has only magnified since the onset of the COVID-19 pandemic in early 2020.
PBMs have adapted their practices by switching to virtual audits, leaving them with the ability to review more claims than ever before. As a result, pharmacies that are juggling the chaos of audit documentation, vaccine distribution, prescription refills, and a plethora of other responsibilities stand to lose. It’s no wonder that the average audit in 2020 cost pharmacies $23,978, which is 35% more than the annual average over the previous 5 years, according to the pharmacy audit assistance service, PAAS National.
Traditionally, a PBM would simply check that the pharmacy received a valid prescription, dispensed the proper amount according to the prescription, and submitted a claim for the correct amount dispensed. But in recent years, the auditing process has evolved into a full-blown investigation, often requiring pharmacies to submit hundreds of pages of documentation—and auditors can even use minor clerical errors as excuses to deny payments.
As pharmacy compliance audits grow in sophistication, it’s up to pharmacies to remain diligent in monitoring their operations, especially the following aspects of their operations in 2022. Here are some tips for getting ahead of and managing audits in the year ahead.
Continue to read the full article here.
Top 3 PAAS eNewsline Exclusive Articles
Your monthly printed Newsline is only a fraction of the content. PAAS Audit Assistance members can log in to the PAAS Portal each month to view the full Newsline edition with audit prevention tips and timely information on PBM audit tactics.
PAAS Audit Assistance member can explore additional eNewsline articles on the PAAS Member Portal.
PAAS Audit Assistance Admins can also add employees to the Portal so that their whole staff has access to the eNewsline.
Keep your employees informed to increase engagement and lower audit results!
Top 10 PAAS National Articles of 2021
PAAS Audit Assistance members receive a monthly newsletter with new audit tactics and prevention tips. The printed newsletter, PAAS National® Newsline is only a fraction of the content that we put out each month as members have access to additional content online in the Member Portal, in addition to an archive of articles.
The top 10 Newsline articles for 2021 include:
PAAS Audit Assistance Admins can also keep their employees informed to increase engagement and lower audit results by adding employees to the Portal so that their whole staff has access to the eNewsline.
Caremark® Turns Up the Heat on Proof of Copay Collection Requests
PAAS National® is seeing a rising number of Caremark® audits requesting proof of copay collection. This requested information may be included in a desk, virtual onsite, or invoice audit. The number of claims requested can range from just a few claims to all dates of fill for several prescriptions.
Having a Point-of-Sale (POS) system may be sufficient for providing proof of copay collection; however, PAAS analysts have seen Caremark® requiring additional documentation to show evidence of payment collection. Providing bank deposits (cash transactions), front and back copies of cancelled checks, and credit card receipts may be necessary.
In addition to proof of copay collection, Caremark® has been known to ask pharmacies to include their policies regarding copay collection and financial hardship, including what documentation is required to determine patient’s financial hardship (i.e., tax returns or approved waiver application). PAAS Fraud, Waste and Abuse and HIPAA Compliance members can reference Section 4.1.5 of their Policy and Procedure Manual for their copay collection policy.
While pharmacies may not be required to collect copays for Medicaid prescriptions, attempts to collect must be made, documented and only waived on a case-by-case basis.
Pharmacies using house charge accounts face additional challenges. Providing itemized invoices showing payments made on the account will likely be required. Written policies and procedures should be in place if charge accounts are used and may be necessary to submit to the PBM.
Secondary payor information (and/or payment) may be necessary when coupons or discount cards are used. Caremark Provider Manual, Section 3.03.03 addresses the use of coupons and other programs. Remember that Medicare, Medicaid and TRICARE prohibit the use of manufacturer coupons and discount programs.
Pharmacies not able to provide sufficient evidence of copay collection not only face full recoupment of claims, but could face termination of contract and risk Fraud, Waste, and Abuse investigations and charges linked to the False Claims Act.
PAAS Tips:
Contact PAAS National® at (608) 873-1342 or visit our website, paasnational.com/buy-now for more information on adding our FWA/HIPAA compliance program.
2022 Fraud, Waste & Abuse and HIPAA Compliance Program Updates
PAAS National® continuously monitors legislative and regulatory changes that may impact your Fraud, Waste & Abuse and HIPAA Compliance Program. We keep a close eye on enforcement from the Department of Justice and Office for Civil Rights to help ensure the program meets interpretative standards. Furthermore, PAAS works to keep pace with Pharmacy Benefit Managers as they continue to add credentialing requirements that can be extremely difficult and a significant nuisance to independent pharmacies.
The PAAS National® FWA/HIPAA Compliance Program has implemented changes to ensure pharmacies continue to have a robust program in place. PAAS FWA/HIPAA compliance members can login to the member portal to view the 2022 FWAC and HIPAA Updates.
Administrators should review all Compliance tasks (located in the left-hand navigation on the PAAS Member Portal) at least annually to keep the program up-to-date and in compliance. Section 2.6 Updates of Policies and Procedures of your manual contains information on maintaining open lines of communication and the distribution of changes.
Contact us TODAY at (608) 873-1342 or info@paasnational.com and add FWA/HIPAA for a discounted rate.
“We have been with PAAS for many years and added the FWAC/HIPAA material to our membership and as a compliance officer, I’ve never been more pleased with the program. If you have already made the best choice to have PAAS in your corner, then continue with the best for your FWAC/HIPAA needs.” – Member since 2010 from North Carolina
“PAAS National® Fraud, Waste, Abuse and Compliance educational sessions are unsurpassed. The PAAS National® Policy and Procedure manual that you create for your pharmacy is a must for all pharmacies to have for their staff. All of this keeps your pharmacy up to date with current pharmacy procedures and operations and ensure proper pharmacy practices going forward.” – Member since 2021 from New York
“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.” – Member since 2009 from Iowa
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: