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:
- See Caremark® 2022 Provider Manual for additional information regarding copay collection:
- 3.03.03 (coupons)
- 3.03.04 (proof of payment)
- 3.03.08 (waivers)
- 3.03.09 (financial hardship)
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:
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.”