Prime Therapeutics
® sent out a 2019 Newsletter stating the dilution of drug products in a foot bath changes the concentration and is thereby considered off-label as this has not been studied or supported to be effective. They require pharmacies to obtain clinical evidence to support the efficacy and safety of dispensing these products in foot baths.
Caremark® sent out provider manual updates for 2020 prohibiting the dispensing of high quantities or high volumes of drugs within a certain category (e.g. topical or dermatological products). Caremark® will monitor claims monthly and if a pharmacy bills 25% or more (in number of claims or dollars) of items on the aberrant product list, the pharmacy will be in a breach of contract. This list can be found on the Caremark Pharmacy Portal.
OptumRx® will mark foot bath prescriptions with a discrepancy code of CLN = no documentation to denote clinical appropriateness was validated.
Express Scripts® has sent out investigative letters referencing section 7.1 of the provider agreement. The pharmacy must respond by completing responses to questions in a letter.
Now, MedImpact® is issuing results with full recoupments on medications used in a foot bath. Their comments are: “Quantity and directions for use of drug appear to be for use in a foot bath. No clinical documentation or evidence exists to substantiate the clinical appropriateness of using this drug in a foot bath. CMS, in collaboration with the I-MEDIC, indicates Topical products are not the standard of care in treatment of foot infections such as diabetic ulcers, and could be actively harmful to the healing process. Further, the purported indications of use of these combinations used in this manner, may not be medically accepted indications (MAIs) and are, at best, investigative and experimental treatments.”
PAAS Tips:
- Be aware that many PBMs are flagging high quantities of topical and injectable medications
- Medicare Part D does not pay for off-label use
- A claim for medication used in a foot bath may seem like a clean claim at adjudication, but it does not guarantee payment
- PAAS advises against billing for topical or injectable products used in a foot bath without sufficient clinical evidence
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
Foot Bath Prescriptions – MedImpact is Now the Fifth PBM Investigating
PAAS National® has alerted members through several Newsline articles of an increase in audits with Prime Therapeutics®, Caremark®, OptumRx® and Express Scripts® investigating foot bath prescriptions. MedImpact® has now jumped on the wagon as well. Topical products and injectables are commonly flagged for high quantities and dollar amounts. PBMs speculate these items are being used off-label due to the large quantities dispensed; and commonly seen in foot bath treatments.
Caremark® sent out provider manual updates for 2020 prohibiting the dispensing of high quantities or high volumes of drugs within a certain category (e.g. topical or dermatological products). Caremark® will monitor claims monthly and if a pharmacy bills 25% or more (in number of claims or dollars) of items on the aberrant product list, the pharmacy will be in a breach of contract. This list can be found on the Caremark Pharmacy Portal.
OptumRx® will mark foot bath prescriptions with a discrepancy code of CLN = no documentation to denote clinical appropriateness was validated.
Express Scripts® has sent out investigative letters referencing section 7.1 of the provider agreement. The pharmacy must respond by completing responses to questions in a letter.
Now, MedImpact® is issuing results with full recoupments on medications used in a foot bath. Their comments are: “Quantity and directions for use of drug appear to be for use in a foot bath. No clinical documentation or evidence exists to substantiate the clinical appropriateness of using this drug in a foot bath. CMS, in collaboration with the I-MEDIC, indicates Topical products are not the standard of care in treatment of foot infections such as diabetic ulcers, and could be actively harmful to the healing process. Further, the purported indications of use of these combinations used in this manner, may not be medically accepted indications (MAIs) and are, at best, investigative and experimental treatments.”
PAAS Tips:
BEWARE: Virtual On-Site Audits Are Coming!
If you haven’t already noticed, most of the PBMs have resumed auditing practices and started issuing on-site audits the first week of August; however, these are not the on-site audits that you are used to. To practice social distancing and protect your staff (and theirs) most PBMs and audit companies have revised these audits as “virtual” and borrowed some elements from traditional desk and on-site audits to create a new Frankenstein’s monster that shifts a large burden onto pharmacies.
While each PBM/audit company has their own unique nuances for these virtual audits, here are some general trends.
Elements from traditional on-site audit method:
Elements from traditional desk audit method: