that a Tracked Safety Issue was opened for insulin pens back in June of 2018. Congruently, the clarification from this October recognizes the following concerns when breaking insulin pen boxes: medication errors (including wrong drug/dose resulting in hyper/hypoglycemia), missed doses, complaints of possible tampering, and dispensing without the Instructions for Use.
The October letter goes on to the following:
- Insulin pens are approved to be dispensed in their original sealed cartons
- Insulin pens are not labeled for dispensing as individual units
- Sealed cartons of insulin pens are intended to be dispensed to a single patient
- Each carton is sealed, with the intent to alert health care professionals and patients when it has been opened, individual insulin pens within the cartons do not have their own sealed package. The carton labeling and sealed packaging are important for both health care professionals and patients.
- The cartons help health care professional and patients differentiate between the insulin pens
However, to the bewilderment of many, the FDA also stated the following:
- The FDA claims the November 2019 revisions stated that health care professionals should dispense the pens to a single patient in the original sealed carton (note should, not must)
- The FDA understands there are situations where health care professionals may choose to dispense individual pens (outside of the carton), not in accordance with FDA-approved labeling, based on their own professional judgement
- Health care professionals should consider the known risks of dispensing individual pens, and incorporate additional safety measures (e.g. adding tamper-indicator tape, providing the Instructions for Use, and labeling individual pens for individual patient use)
So, what does this all mean for community pharmacies? More of the status quo – don’t break the box. While the FDA may “understand” and permit dispensing of individual pens on an exception basis, payers (and PBMs) may not. PAAS often sees PBMs hold pharmacies accountable for FDA labeling requirements (e.g. dispense in the original container medications). Moreover, pharmacists could incur additional liability by choosing to go against FDA labeling requirements despite warnings from the FDA.
PAAS Tips:
- Pharmacies should always try to first bill an accurate days’ supply based on the prescribed quantity– many insurers have accommodated days’ supply limits well in excess of 90 days
- If plan limits are exceeded follow the guidance below:
- Multiple cartons – reduce the # of cartons and corresponding days’ supply until the claim will adjudicate. Document Insurance Limits Quantity (e.g. ILQ = 30 days) on the hard copy.
- Single carton (in order of preference):
- Call the PBM help desk and request an override
- If no override is available, adjust the days’ supply to the Plan Limit
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
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:
Serve You Rx
TRICARE
Scripts
Caremark
Elixir
MagellanRx
MedImpact
Navitus
OptumRx
Prime Therapeutics
Scripts
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.
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
The October letter goes on to the following:
However, to the bewilderment of many, the FDA also stated the following:
So, what does this all mean for community pharmacies? More of the status quo – don’t break the box. While the FDA may “understand” and permit dispensing of individual pens on an exception basis, payers (and PBMs) may not. PAAS often sees PBMs hold pharmacies accountable for FDA labeling requirements (e.g. dispense in the original container medications). Moreover, pharmacists could incur additional liability by choosing to go against FDA labeling requirements despite warnings from the FDA.
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:
Nine Pharmacists Charged in $12 Million Fraud Related to Invoice Shortages
Nine pharmacists were recently indicted on felony charges in a $12.1 million health care fraud scheme according to a June 17, 2020 U.S. Department of Justice press release. The licensed pharmacists and pharmacy owners in Detroit and southern Ohio are alleged to have billed Medicare, Medicaid and Blue Cross Blue Shield for medications that were neither purchased nor dispensed, resulting in invoice shortages. Additionally, they are alleged to have provided kickbacks to prescribers, waived patient copays and billed claims for medications purportedly dispensed to beneficiaries after their death.
Headlines like these are the fuel that PBMs use to ramp up invoice audits. While these examples represent a very small minority of pharmacists, they tarnish the reputation of independent pharmacies nationwide.
PAAS Tips:Join today!
- Review your purchasing, billing and documentation procedures to ensure that you are prepared should the inevitable invoice audit happen at your pharmacy
- Consider performing a mock audit as discussed in the January 2020 article Self-Audit Series #12: Invoice Audit to identify any discrepancies now which will provide your pharmacy the opportunity to fix the problem prior to an official audit
- Notify PAAS immediately of any invoice audit so that we can help guide you through a comprehensive response