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.
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.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
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:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
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:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Mid-Level Practitioners and Their Supervising Physicians– Documentation Required?
PAAS National® has seen a recent uptick in the number of prescriptions being found discrepant for missing the supervising physician when written by a mid-level practitioner (e.g. physician assistant or nurse practitioner). Laws pertaining to mid-level practitioners are specific to each state and may differ between physician assistants and nurse practitioners. Because these regulations may be found through the Board of Medicine or Board of Nursing, pharmacies are not always aware of the requirements to make a valid prescription. In particular, many states require the name of the supervising physician be present on the prescription hard copy.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
PAAS National® is committed to serving your needs and helping you reduce audit risk.
FDA Guidance on Insulin Pens Puzzling
On October 13, 2020, the U.S. Food and Drug Administration issued a statement looking to clarify the intent of the November 2019 label revisions for insulin pens. The updated labeling contained “Dispense in this sealed carton” on insulin pen boxes and Section 16.2 of the package inserts state: “Dispense in the original sealed carton with the enclosed Instructions for Use.” PAAS National® Members should be familiar with our February Urgent Email Alert and subsequent Newsline articles in March and April.
Looking to get further clarity into the rationale for the labeling change, PAAS had submitted a Freedom of Information Act request to the FDA. In response, PAAS learned
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Members can view our eNewsline in the member portal for additional PAAS Tips.
COVID-19 Vaccine: Are You Prepared to Administer?
Healthcare providers will play a key role when a COVID-19 vaccine becomes available. CMS has issued a set of toolkits for providers, states and insurers to help in preparation of administering the vaccine when it becomes available. Medicare has provided these resources to help increase the number of providers that can administer the vaccine and ensure ample reimbursement for administration. They have also made it clear to Medicaid and private insurers their responsibility to cover the cost of the vaccine at no charge to the patient.
If you are not a Medicare enrolled provider then you need to enroll as a mass immunizer or other provider type to be able to bill for administering the vaccine. Please review the toolkits to see if your pharmacy needs to update your provider type. The toolkits explain how a pharmacy can enroll and discusses the Medicare coding structure and reimbursement strategy.
Medicare has established administration payment rates for the 2-dose series at $16.94 for the initial dose, and $28.39 for the final dose – incentivizing pharmacies and other providers to make sure the patient comes back for the second dose.
PAAS Tips:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips: