PAAS National® continuously keeps close tabs on legislative and regulatory changes that may impact our members’ Fraud, Waste & Abuse and HIPAA Compliance Program. Monitoring enforcement from the Department of Justice and the Office for Civil Rights (OCR) also allows us to be aware of interpretative standards as well.
Furthermore, Pharmacy Benefit Managers (PBMs) are continuously adding and changing requirements to their credentialing process. Pharmacies need to be certain they are ready for these changes. The PAAS National® FWA/HIPAA Compliance Program has implemented changes to ensure pharmacies with our program will continue to have robust policies in place.
Does your pharmacy have a policy for Timely Submission of Claims? PAAS has increasingly become aware of this credentialing requirement. Having written policies in place will assist you with credentialing responses. PAAS FWA/HIPAA compliance members can now find this in Section 4.1.8 of their Policy and Procedure Manual.
It is also important for pharmacies to be aware of OCR’s stepped-up enforcement for Pharmacies who are not providing timely access to patient records – fines for violations have exceeded $200,000. PAAS FWA/HIPAA compliance members should review Section 10.5.1.1 of their Policy and Procedure Manual and review our January 2020 Newsline article First Two Settlements for HIPAA Right of Access Initiative by OCR.
PAAS FWA/HIPAA compliance members can login to the member portal to view the full memo of 2021 FWAC and HIPAA Updates.
With our 24/7 web-based Portal, extensive customization, and ease of use, it’s easy to see why most PAAS members use our FWA/HIPAA compliance program.
FWA and HIPAA Compliance with Job Shadows and Interns
Students performing a job shadow or internship in the pharmacy need proper FWA/HIPAA training and preparation to be behind the pharmacy counter or you are inviting headaches into your operations (and potential legal complications).
Pharmacy students completing their internship typically spend more time in the pharmacy than someone job shadowing. Interns assisting with daily operations such as billing, filling, counseling, and other professional services, must also complete FWA training. Though their time with your pharmacy may be temporary, these students have access to many of the same pharmacy operations as regular employees. The potential to oversee or partake in wasteful practices, diversion, or other fraudulent activities exists and FWA training must be completed. PAAS National® also recommends completing exclusion checks for interns against both the Office of Inspector General (OIG) and General Services Administration (GSA) lists.
PAAS FWA/HIPAA Compliance members can easily add students to your employee list in the PAAS Member Portal to give them access to the FWA/HIPAA online training modules and automatically receive daily OIG and GSA exclusion checks when the student’s profile is created.
PAAS Tips:
Contact PAAS National® at (608) 873-1342 or info@paasnational.com for assistance regarding student access to the portal or to become an FWA/HIPAA Compliance member.
Pitfalls of Transferred Prescriptions
Transferred prescriptions are at high risk for audit recoupments. Every element required by state regulations is one additional pitfall that PBMs utilize to try and recoup on claims. These prescriptions are easily identified due to their origin code. The NCPDP Telecommunication Version D section 3.1.4 explains that an origin code of 5 is utilized for any pharmacy created prescription, which includes when pharmacists have authority to prescribe, when dispensing off a protocol and for prescriptions transferred in.
PAAS National® analysts frequently see audit results with recoupments for:
PAAS Tips:
Updated Dispense in Original Container Chart
Medications that are required to be dispensed in their original container continue to appear in audits. Billing for a quantity that is not divisible by the full bottle size is a red flag to the PBM and, unfortunately, easily recoupable. Many of these products are sensitive to light/moisture or have only been studied under storage in their original container; thus, removing them from the original package may cause stability and potency issues. Product labeling can be obtained from the FDA’s DailyMed website, which was referenced by PAAS National® to update the Dispense in Original Container chart under the Tools & Aids section of the PAAS member portal.
For example, PAAS analysts have seen an increase in
Additionally, pharmacies dispensing to nursing homes or providing medication packaging to patients in the retail pharmacy setting must also follow the FDA guidelines to dispense in the original container.
PAAS Tips:
Fraud, Waste, & Abuse and HIPAA Compliance Updates for 2021
PAAS National® continuously keeps close tabs on legislative and regulatory changes that may impact our members’ Fraud, Waste & Abuse and HIPAA Compliance Program. Monitoring enforcement from the Department of Justice and the Office for Civil Rights (OCR) also allows us to be aware of interpretative standards as well.
Furthermore, Pharmacy Benefit Managers (PBMs) are continuously adding and changing requirements to their credentialing process. Pharmacies need to be certain they are ready for these changes. The PAAS National® FWA/HIPAA Compliance Program has implemented changes to ensure pharmacies with our program will continue to have robust policies in place.
Does your pharmacy have a policy for Timely Submission of Claims? PAAS has increasingly become aware of this credentialing requirement. Having written policies in place will assist you with credentialing responses. PAAS FWA/HIPAA compliance members can now find this in Section 4.1.8 of their Policy and Procedure Manual.
It is also important for pharmacies to be aware of OCR’s stepped-up enforcement for Pharmacies who are not providing timely access to patient records – fines for violations have exceeded $200,000. PAAS FWA/HIPAA compliance members should review Section 10.5.1.1 of their Policy and Procedure Manual and review our January 2020 Newsline article First Two Settlements for HIPAA Right of Access Initiative by OCR.
PAAS FWA/HIPAA compliance members can login to the member portal to view the full memo of 2021 FWAC and HIPAA Updates.
With our 24/7 web-based Portal, extensive customization, and ease of use, it’s easy to see why most PAAS members use our FWA/HIPAA compliance program.
Are You Documenting DUR and Submission Clarification Codes?
PAAS National® is continuing to see Express Scripts (ESI) and Tricare flag claims for audit where clinical drug utilization review (DUR) or submission clarification codes (SCC), were submitted. Prime Therapeutics, now processed by ESI, has now joined in. Recoupments are happening due to “No DUR documentation” or “No SCC documentation.” Pharmacies that fail to show documentation of the support codes used on the prescription are facing recoupment.
Dispensing pharmacists must use professional judgement when receiving a point-of-sale reject. If choosing to dispense a medication using an override code, it is imperative that supporting documentation be placed on the prescription to support its utilization. This documentation should contain detailed information with dates, names, titles, and discussions that took place if patients, or prescribers, were consulted. Lack of this documentation can lead to recoupment.
Most common SCCs subject to audit (as defined by NCPDP) are:
Please click here to view all 37 NCPDP Submission Clarification Codes and their corresponding definitions. There are additional codes found in the link that pertain to LTC billing, compounds and 340B. Drug utilization review codes can be found as follows: Reason for Service Code, Professional Service Code (NCPDP 440-E5) and Result of Service Code.
PAAS Tips:
340B Contract Pharmacy Claims Identification and Submission Requirements
Major PBM Updates Network Provider Manual
For 2021, a major PBM updated their provider manual regarding their position on the 340B drug discount program. Previously stating the PBM encourages Network Providers to identify 340B claims, in 2021 that language was updated to state Providers must identify the claims. This update included a March 1, 2021 effective date for processing what is called N1 (information reporting) transactions. Read the full release.
Webinar: 340B Contract Pharmacy Considerations for 2021
PAAS National® is hosting a webinar on Wednesday, March 3 from 2:00-2:45 p.m. CST
We look forward to you joining us as President of PAAS National®, Trenton Thiede, PharmD, MBA:
Bring your questions, we will do our best to allow some time for Q&A at the end of the webinar.
PAAS Audit Assistance members will have access to a recording on the member portal if you are unable to attend the live event.
Reminder first step to using your audit assistance with PAAS National® is when you receive an audit notice call PAAS 608.873.1342 to get a case set-up then email info@paasnational.com or fax 608.873.4009 in your audit notice.
Our all-inclusive audit assistance membership means there are no hidden fees or limits to the audit assistance you can receive. We are here to help you!
FDA Requests Updated Product Labeling on Insulin Pens
Stop Breaking Insulin Pen Boxes
The pharmacy industry has long debated whether one box of insulin pens is considered “unbreakable”. The debate appeared to be settled January 22nd, 2019 when the U.S. Department of Justice issued a press release stating Walgreens agreed to a $209 million fraud settlement with the federal government regarding its billing and dispensing of insulin pens to Medicaid, Medicare Part D and TRICARE patients. Prior to the settlement, Walgreens’ policy was to not dispense any insulin pens in quantities less than one full box, forcing their staff to falsely understate the days’ supply on thousands of claims. They then enrolled many of these patients on its refill reminder program, causing patients to get early refills. The government labeled that billing activity as
widespread FRAUD and required Walgreens to enter into a Corporate Integrity Agreement with the Office of the Inspector General. Consequently, both Walgreens and CVS have been breaking insulin pen boxes when appropriate. Read the full urgent member alert here.
Caremark Manufacturer Coupon Policy
PAAS National® continues to see pharmacies suffer full recoupment on claims that are processed to coupons and copay cards in violation of Caremark’s policy found in section 3.03.03 of the 2020 Pharmacy Provider Manual. Violations are considered [by Caremark] to be an inappropriate waiver of patient pay amounts and could result in additional sanctions, including termination.
As defined in the current Provider Manual: “Pharmaceutical Manufacturer Coupon” means any item or mechanism, including but not limited to, paper coupons, copay cards, e-vouchers, mail-in rebates, and electronic coupon codes funded by a manufacturer, repackager, or supplier of pharmaceutical, chemical, or compounding products, that reduces the portion of the Patient Pay Amount that an Eligible Person is required to pay for a Covered Item.
Manufacturer coupons may be accepted if:
a. Approved as a brand (NDA) or generic (ANDA) drug and published in the FDA Orange Book
b. Approved under a Biologics License Application (BLA) and published in the FDA Purple Book
c. Over-the-Counter (OTC) item marketed under an official final OTC monograph
d. Grandfathered drug marketed before 1938 or 1962, or is otherwise considered Generally Recognized as Safe and Effective (GRASE) by the FDA
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PBM Enforcement of Return to Stock Policies
PAAS National® wrote an article in our April 2020 Newsline regarding PBMs Enforcing Return to Stock Policies. A PBM will recoup a claim in full if a medication is picked up after their required return to stock timeframes listed in the respective provider manuals. The provider manual may reference these as “unclaimed prescriptions.” Pharmacies should have a policy and procedure in place to only allow medications to remain in the will call bins for the shortest outlined time – 10 days. If your pharmacy has PAAS National®’s Fraud, Waste & Abuse and HIPAA Compliance (FWAC) program, a return to stock policy is available to you, including a log to help you document and complete this task (see section 4.1.1 Unclaimed Prescriptions and Appendix B – Unclaimed Prescription Reversal Log).
Major PBM Return to Stock Timeframes:
Serve You Rx
TRICARE
Scripts
Caremark
Elixir
MagellanRx
MedImpact
Navitus
OptumRx
Prime Therapeutics
Scripts
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