Claim Processing
1. Will PBMs allow claims with a days’ supply greater than 90?
Many pharmacies report that claims will successfully process for greater than 90 days. Pharmacies should always start by submitting an accurate days’ supply for a full box and follow plan messaging, See Can You Bill It As 30 Days? for additional guidance.
2. Why is my reimbursement going down?
We suspect that pharmacies are processing more insulin pen claims for extended day’s supply (> 30 days). PBM contracts have more aggressive rates for extended days’ supply dispensing. Pharmacies may consider contacting their PSAO or the PBM to try to opt out of these networks. Submitting a false days’ supply (e.g. 30 days) when the product should really last 90 days, and the plan allows 90 days, is a contractual violation and would probably be considered fraudulent.
LTC Pharmacy
3. Does this apply to LTC practice?
Yes, FDA-approved labeling applies to all practice settings and pay types.
Audits
4. Will PBMs issue written guidance such as fax memos or update Provider Manuals?
There was no explicit guidance issued subsequent to the Walgreens’ DOJ decision, but most PBMs were quick to audit claims and enforce. We continue to encourage various audit departments to provide clear expectations on audit policies. On March 20, OptumRx sent a one-page memo entitled “Accurate Billing for Insulin Pens” confirming the FDA labeling update and reminding Network Pharmacies how to correctly submit claims. In particular, Optum states:
- Pharmacy Provider must request an override through the pharmacy help desk when rejected for plan limits and dispensing in the smallest commercially available package size (typically 15 mL per carton).
- If an override is not available and the days’ supply is altered, pharmacies must ensure the refill interval is based on the actual days’ supply, not the submitted days’ supply (or risk audit recoupments).
PAAS is not aware of additional PBM guidance; and much like MAC pricing, the more vague and opaque policies are, the more broadly they can be applied to benefit the PBM.
Smartphones Put Pharmacies at Risk for Inappropriate PHI Disclosures
PAAS National®’s Fraud, Waste, and Abuse and HIPAA compliance program updates for 2020 included a new section: 11.11.5 Audio, Video, and Social Media (see our February article FWA/HIPAA Compliance Program Changes for 2020). Smartphone utilization has, unfortunately, become pervasive with patient interactions. Patients on their phone while trying to consult on new medications, or a patient snapchatting a friend while waiting for their prescription to be filled is all too common.
Pharmacies need to developJoin today!
- Confirm your HIPAA compliance program is staying relevant
- Ensure employees are adequately trained on HIPAA to mitigate risk (see our eNewsline for an OCR fine that cost a provider $10,000)
- Compliance programs offered through an entity affiliation may not be the best choice to protect your pharmacy.
and enforce a policy to mitigate inappropriate protected health information (PHI) disclosure risk given the tendency for patients to have their phone accessible at the pharmacy counter and in the patient waiting area. It is the pharmacy’s responsibility to safeguard the PHI of patients, which can include audio/video recordings by someone other than the patient. Staff awareness and training become a critical component to enforcing these policies and handling them with tact.
Discovering a PHI breach occurred through an audio/video recording needs to be documented appropriately and handled swiftly. A patient, or customer, who obtains another patient’s PHI through inappropriate methods [in the pharmacy] should be banned from the pharmacy and, if PHI was posted on social media, requested to remove the offending content. Should they refuse or fail to act promptly, reaching out to the social media platform to request removal of the offending breach would be prudent. These efforts need to be documented thoroughly in an incident report.
See the full list of 2020 FWA/HIPAA changes with additional updates on the PAAS Portal. PAAS works tirelessly to keep you one step ahead of the game and in compliance.
PAAS Tips:
PAAS Audit Assistance members can view the full article on our eNewsline.
COVID-19 Audit Considerations Follow-Up
On April 3, 2020, PAAS National® sent an urgent email alert to all members discussing COVID-19 audit considerations. This email came as a result of our desire to help pharmacies on the frontlines of this pandemic.
If you did not receive our email, please see the COVID-19 Audit Considerations memo for useful audit tips and guidance to avoid pitfalls. Emails were sent to the email addresses we have on file for your pharmacy and primary contact person. If your pharmacy missed the communication, please call or email us to update your account.
PAAS wants you to stay informed of PBM requirements to help keep your staff, patients, and business safe. Since mid-March, we have been advocating for and tracking reductions, and outright waivers, of specific PBM requirements, most notably:
The pandemic is extremely fluid, with changing dynamics and daily updates from PBMs. We have analyzed over 40 PBM communications in the last couple of weeks (just looking at national plans), and it’s vital that pharmacies be vigilant on the fine print.
PBMs will continue to use any technical discrepancy to deny claims on an audit, and these temporary waivers only increase the likelihood that pharmacies will face recoupments. PBMs will be auditing this time period, specifically looking to recoup high dollar claims without supporting documentation – in FULL.
Be careful of waiver/concession expiration dates – there will be no leeway when it comes to auditing these claims after the fact. Pay close attention to PBM communications and save our summary chart link of current concessions; you’ll want to keep a close eye on changes.
Caremark Enforcement: Aberrant Quantities & Volumes
PAAS is starting to see Caremark enforce their new policy about Aberrant Quantities and Volume that we first wrote about in a December 2019 article Important: Caremark Provider Manual Updates for 2020!. These notifications state that pharmacies have breached the Provider Agreement and the pharmacy is receiving a formal breach notice as a warning.Join today!
- The Aberrant Drug List was updated March 6, 2020
- Current list is available on Caremark’s Pharmacy Portal at https://rxservices.cvscaremark.com
Caremark updated the Provider Agreement in November 2019 (effective January 1, 2020) to require pharmacies to dispense less than 25% of claims (by claim count or dollar amount) of select medications they consider to be at high risk for Fraud, Waste or Abuse. Exceeding this 25% threshold is deemed “aberrant” dispensing. Caremark states they will monitor pharmacies on a monthly basis and if you violate the 25% threshold after receiving a breach notice, you will be subject to claim recoupment and/or network termination.
While The Aberrant Drug List is unique to Caremark, all PBMs are auditing for these types of medications. PAAS has seen numerous examples of pharmacies losing claims during audits for soliciting prescriptions of these “special” dosage strengths. We advise pharmacies to be extremely cautious about this type of dispensing as it echoes the issue of repacking NDCs at inflated AWPs from the mid-2000s.
PAAS Tips:
PBMs Enforcing Return to Stock Policies
It is common practice for PBMs to recoup claims [in full] for medications being picked up after the return to stock timeframes listed in their provider manuals (also known as “unclaimed prescriptions”). Pharmacies with an integrated Point-of-Sale should look to generate a list of prescriptions near the allowed timespan for medications to be left in pick-up bins. PAAS recommends pharmacies implement a procedure to only allow medications to remain for the shortest outlined time – 10 days. If your pharmacy has PAAS National®’s Fraud, Waste & Abuse program, a return to stock policy is available to you, including a log to help you document & complete this task (see section 4.1.1 Unclaimed Prescriptions and Appendix B – Unclaimed Prescription Reversal Log).
Major PBM Return to Stock Timeframes:
Stop Breaking Insulin Pen Boxes– Your Questions Answered
On February 18, 2020, PAAS National® sent an email to all members discussing our revised recommendation: STOP breaking insulin pen boxes. This recommendation came as a result of the FDA-approved product labeling change for insulin pens; effective November 15, 2019.
If you did not receive our email, please see the Stop Breaking Insulin Pen Boxes article from our March 2020 Newsline for more details.
Since that time, we have received many questions from pharmacies regarding this important change. Here are the most common questions:Join today!
- Pharmacy Provider must request an override through the pharmacy help desk when rejected for plan limits and dispensing in the smallest commercially available package size (typically 15 mL per carton).
- If an override is not available and the days’ supply is altered, pharmacies must ensure the refill interval is based on the actual days’ supply, not the submitted days’ supply (or risk audit recoupments).
Claim Processing
1. Will PBMs allow claims with a days’ supply greater than 90?
Many pharmacies report that claims will successfully process for greater than 90 days. Pharmacies should always start by submitting an accurate days’ supply for a full box and follow plan messaging, See Can You Bill It As 30 Days? for additional guidance.
2. Why is my reimbursement going down?
We suspect that pharmacies are processing more insulin pen claims for extended day’s supply (> 30 days). PBM contracts have more aggressive rates for extended days’ supply dispensing. Pharmacies may consider contacting their PSAO or the PBM to try to opt out of these networks. Submitting a false days’ supply (e.g. 30 days) when the product should really last 90 days, and the plan allows 90 days, is a contractual violation and would probably be considered fraudulent.
LTC Pharmacy
3. Does this apply to LTC practice?
Yes, FDA-approved labeling applies to all practice settings and pay types.
Audits
4. Will PBMs issue written guidance such as fax memos or update Provider Manuals?
There was no explicit guidance issued subsequent to the Walgreens’ DOJ decision, but most PBMs were quick to audit claims and enforce. We continue to encourage various audit departments to provide clear expectations on audit policies. On March 20, OptumRx sent a one-page memo entitled “Accurate Billing for Insulin Pens” confirming the FDA labeling update and reminding Network Pharmacies how to correctly submit claims. In particular, Optum states:
PAAS is not aware of additional PBM guidance; and much like MAC pricing, the more vague and opaque policies are, the more broadly they can be applied to benefit the PBM.
Additional questions answered on the eNewsline:
PBMs Require “Cut Quantity” Documentation
Whenever a pharmacy dispenses a quantity less than what the prescriber ordered, there should be a reason documented for the “cut quantity”. PBMs want to know why the pharmacy is dispensing less than what was prescribed. There are many reasons why this could happen, but the three most common are:
PAAS has seen a few PBMs try to recoup on cut quantities if the pharmacy did not have the reason documented. PAAS Audit Assistance members can view chart of audit discrepancy codes on eNewsline.
PAAS Tips:
COVID-19 Resources
PAAS National® was proud to support you during the PHE for COVID-19 and we want to thank you for your endurance, perseverance, and service to our communities. Due to the PHE ending, resources on this page have changed. Please contact PAAS for the most up-to-date information.
COVID-19 Vaccine Self Attestation
First released 9/27/2021, last updated 8/3/2023
COVID-19 PBM Concessions
First released 5/2020, last updated 5/9/2023
COVID-19 Audit Considerations
First released 4/2020
Medicare and Commercially Insured Patient Request and Attestation for OTC COVID-19 Test Billing
Last updated 4/4/2022
Medicare and Commercially-Insured OTC COVID-19 Tests Frequently Asked Questions (FAQ)
First released 2/2/2022, last updated 4/4/2022
Webinar: PBM FWA Trends and COVID-19 Vaccine Audit Risks
Recorded: 11/18/22
We want to help you stay informed of PBM requirements to help keep your staff, patients, and business safe. The above resources were sent to our members upon the initial release, and members are the first to know any updates, as we are in a consistent evolving state and receiving daily updates from PBMs. Become a PAAS Member Today – call 608-873-1342 or online at PAASNational.com
PBMs will continue to use any technical discrepancy to deny claims on an audit, and these temporary waivers only increase the likelihood that pharmacies will face recoupments. PBMs will be auditing this time period, specifically looking to recoup high dollar claims without supporting documentation – in FULL.
GoodRx Shares Consumer Data
GoodRx, the website and app that has a seemingly endless TV marketing budget, has been sharing their consumer data with Facebook, Google, and others according to a recent article by Consumer Reports. During testing, Consumer Reports found that, “a company could infer highly intimate details about GoodRx users suffering from serious chronic conditions and make educated guesses about their sexual orientation.”
One company that GoodRx has shared consumer information with is Braze, a marketing firm, which claims that the data they collect is only used to target GoodRx users with information and not shared broadly with other advertising companies. GoodRx states Braze is used to send email or text reminders when a consumer is running low on their medication. Another company, Branch, claims it uses GoodRx data to make sure links work correctly in the mobile app.
According to Consumer Reports, both Facebook and Google have denied that they use prescription information to target consumers with ads, especially based on sensitive information like a person’s personal health information. However, Consumer Report’s Digital Lab observed sensitive information being passed to these companies and believes the app and website could be redesigned to prevent it from happening.
The big questions are: Is this legal? Doesn’t HIPAA apply?
Because GoodRx is a private company with no doctors or hospitals involved, it does not have to protect the health data a consumer gives it. Many consumers would be surprised to hear about this, although it is good to remember that if a service is free, the real product is the consumer and his or her data, and how a company shares consumer data is usually located in the fine print.
Shortly after the Consumer Report’s article came out, GoodRx posted a statement apologizing for the Facebook advertising in particular and vowing to “do better.” They also stated they would appoint a new VP of Data Privacy, make it possible for consumers to opt-out from cookies and tracking, and allow consumers to delete their data.
Auditors Targeting Ladder Schedule II Prescriptions
PAAS has been seeing an increase in audits for ‘laddered’ controlled substance prescriptions. A ladder prescription is a Schedule II controlled substance written as multiple prescriptions issued on the same date. This allows for fewer prescriber office visits where refills are not allowed by DEA regulations. They are commonly written for routine ADHD and pain medications.
The DEA has specific regulations for the issuance of multiple prescriptions for Schedule 2 controlled substances in 21 CFR §1306.12. The requirements include:
PAAS Tips:Join today!
- Make sure that multiple prescriptions do not exceed a 90-day supply
- Most common is 3 x 30-day supply prescriptions
- 6 x 15-day supply may be allowed
- Cannot do 4 x 30-day supply or 3 x 31-day supply
- Ensure that all prescriptions have the same issue or written date
- This must be the date that the prescriber signed or issued the prescriptions
- Written date must be accurately entered into the prescription claim
- Do not use the ‘Fill on’ date as the written date
- Entering the wrong date can lead to Wrong Hard Copy or Invalid Written Date discrepancies. It may also result in a claim being filled past the normal expiration date
- Ensure that at least the 2nd and 3rd prescriptions have the ‘Fill on’ or dispense date clearly indicated
- Must be an actual date
- ‘Fill 30 days after xx/xx/xx’ is NOT accepted
- Ensure that all DEA required elements are present on the front face of the prescription
- Patient name and address
- Prescriber name, address, and DEA
- Follow all state requirements for dispensing Schedule 2 controlled substances:
- Prescription expiration after written
- Varies from 7-90 days after written date
- Supervising physician information for mid-level practitioners
- May require supervisor’s name, address, phone, NPI, and/or DEA
- What can be changed or clarified on a Schedule 2 prescription
- DEA no longer allows changes to a Schedule 2 prescription unless specifically allowed by state regulations
- Verify with your State Board of Pharmacy
Stop Breaking Insulin Pen Boxes
PAAS National® sent out an URGENT Email Alert February 18, 2020 regarding the FDA’s involvement in the breaking of 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.
Since that time, PAAS has seen OptumRx, Express Scripts, Humana, Prime Therapeutics, and EnvisionRx dramatically increase their audit recoupments on insulin pens being dispensed that exceed plan limits.
To complicate the matter, the FDA got involved June 20th, 2019 when it sent a “Safety-Related Supplement Request” to Eli Lilly, Sanofi, and Novo Nordisk requesting:
“…updates to the Prescribing Information (PI) and carton labeling to specify that pens be dispensed in the original sealed carton…”
Regardless, it is important to note that PBMs are aware and will likely enforce the revised standard during audits (i.e. do not break insulin pen boxes). PAAS just received audit results where the PBM expected insulin pen boxes to have been broken between 1/22/2019-11/15/2019, and post-11/15/2019 they are expecting full insulin pen boxes to be dispensed. The absurdity is not lost on PAAS, but PBMs will use anything they can to deny paying claims – especially high dollar insulin claims.
Updated Section 16.2 of the package insert, and the exterior carton, will now state to dispense in the original sealed carton. Your supply chain and inventory management will dictate when you start seeing the revised product labeling, if you haven’t already.
16.2 Storage
Dispense in the original sealed carton with the enclosed Instructions for Use.
PAAS Tips:
PAAS Audit Assistance members can visit our Tools & Aids to find updated versions of our popular tip sheets: