As of this publication, recoupments on type 2 diabetes mellitus (T2DM) GLP-1 agonists due to off-label indication use, defined as anything other than being used as an adjunct therapy for adults with T2DM, is nominal. Elixir communicated via their Pharmacy Audit Whisperer from April 2023 that Ozempic® and MounjaroTM being used for an indication of obesity or weight loss would not be covered and they have pursued recoupment of such claims. Caremark has been sending notices to pharmacies dispensing GLP-1 agonist at a volume identified as an outlier in their region. We’ve also seen OptumRx/EXL Health flag Ozempic® for off-label use. Notably, PAAS is aware of nine state Medicaid programs that were negotiating prices for Wegovy® earlier this year.
Despite the de minimis recoupments seen thus far, PBMs and insurance companies have put out communications advising pharmacies they reserve the right to report suspected improper dispensing practices to federal or state agencies, which may result in an additional level of scrutiny placed on pharmacies. As it states in Section 10.6 – “Medically-Accepted Indication” of the Medicare Part D Manual, “Part D sponsors are responsible for ensuring that covered Part D drugs are prescribed for medically-accepted indications using the tools and data available to them to make such determinations.” Therefore, according to this guideline, Medicare Part D may pay for a GLP-1 agonists prescribed for its appropriate indication but will not pay for a GLP-1 agonist with an indication that does not match the patient’s intended use. In addition to being mindful of the CMS billing guidelines, pharmacies must be mindful of individual PBM’s expectations for billing practices. Some PBM’s have explicit language in their Provider Manuals that define “clean claims” as one that is used for a medically accepted indication or outlines “appropriate dispensing practices”, both alluding to claims that are for medically accepted indications. Yet pharmacies have processed prescriptions for off-label use without issue. If Medicare Part D states they will not pay for off label use, then why are these claims to go through without issue? If commercial plans state they will only cover medication for certain indications, why not put diagnosis restrictions in place to stop claims from going through at the point of adjudication? We know that PBMs have highly intricate algorithms that can focus in on prescription specifications; why aren’t they targeting GLP-1 agonists being used off-label on audits? One could speculate due to the vast amount of administration fees and rebates they are currently reaping there isn’t a reason to impose their regulation at this time, but these claims may be in the PBM’s crosshairs in the coming years. After all, audits typically target claims from previous years and PBMs do not mind using a “pay and chase” approach because they can just withhold future payments.
Beyond audits originating from PBMs for off-label use, manufacturers can cause trouble as well. Eli Lilly and Novo Nordisk have sued medi-spas, clinics, and compounding pharmacies over counterfeit versions of their GLP-1 agonists.
Ultimately, we urge you to consider the following when deciding how to handle adjudicating GLP-1 agonist prescriptions for off-label use: “How much do you trust the PBM to act favorably to your pharmacy – now and in the future?” While the future of GLP-1 agonist audits is obscure, our guidance remains conservative – tread cautiously.
PAAS Tips:
- When diagnosis codes are known, be sure the prescription is written for the appropriate GLP-1
- If you are dispensing MounjaroTM for weight loss, best practice would be to contact the prescriber for a new prescription for ZepboundTM
- Refresh yourself on PAAS’ suggested workflow when approaching GLP-1 agonist claims, outlined in the May 2023 Newsline article, Best Practices for Dispensing GLP-1 Medications and Reducing Recoupment Risk
Zepbound (tirzepatide) Means Decreased Audit Risk…Right?
On November 3, 2023, Eli-Lilly was granted the highly anticipated weight loss indication on their tirzepatide injection, ZepboundTM. ZepboundTM is indicated as an adjunctive therapy for adults with a body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) plus at least one weight-related comorbidity, such as type 2 diabetes mellitus, dyslipidemia, or hypertension – the same indication as Wegovy® and Saxenda®. Although this is an exciting advancement in the realm of GLP-1 agonist prescribing, PAAS National® would like to take this opportunity to update our members on what PBM trends we have seen thus far, draw attention to the guidelines laid out by PBMs and regulations in which we can rely on, and give our thoughts on the current audit situation in the hopes of allowing you to make the most informed business decision.
As of this publication, recoupments on type 2 diabetes mellitus (T2DM) GLP-1 agonists due to off-label indication use, defined as anything other than being used as an adjunct therapy for adults with T2DM, is nominal. Elixir communicated via their Pharmacy Audit Whisperer from April 2023 that Ozempic® and MounjaroTM being used for an indication of obesity or weight loss would not be covered and they have pursued recoupment of such claims. Caremark has been sending notices to pharmacies dispensing GLP-1 agonist at a volume identified as an outlier in their region. We’ve also seen OptumRx/EXL Health flag Ozempic® for off-label use. Notably, PAAS is aware of nine state Medicaid programs that were negotiating prices for Wegovy® earlier this year.
Despite the de minimis recoupments seen thus far, PBMs and insurance companies have put out communications advising pharmacies they reserve the right to report suspected improper dispensing practices to federal or state agencies, which may result in an additional level of scrutiny placed on pharmacies. As it states in Section 10.6 – “Medically-Accepted Indication” of the Medicare Part D Manual, “Part D sponsors are responsible for ensuring that covered Part D drugs are prescribed for medically-accepted indications using the tools and data available to them to make such determinations.” Therefore, according to this guideline, Medicare Part D may pay for a GLP-1 agonists prescribed for its appropriate indication but will not pay for a GLP-1 agonist with an indication that does not match the patient’s intended use. In addition to being mindful of the CMS billing guidelines, pharmacies must be mindful of individual PBM’s expectations for billing practices. Some PBM’s have explicit language in their Provider Manuals that define “clean claims” as one that is used for a medically accepted indication or outlines “appropriate dispensing practices”, both alluding to claims that are for medically accepted indications. Yet pharmacies have processed prescriptions for off-label use without issue. If Medicare Part D states they will not pay for off label use, then why are these claims to go through without issue? If commercial plans state they will only cover medication for certain indications, why not put diagnosis restrictions in place to stop claims from going through at the point of adjudication? We know that PBMs have highly intricate algorithms that can focus in on prescription specifications; why aren’t they targeting GLP-1 agonists being used off-label on audits? One could speculate due to the vast amount of administration fees and rebates they are currently reaping there isn’t a reason to impose their regulation at this time, but these claims may be in the PBM’s crosshairs in the coming years. After all, audits typically target claims from previous years and PBMs do not mind using a “pay and chase” approach because they can just withhold future payments.
Beyond audits originating from PBMs for off-label use, manufacturers can cause trouble as well. Eli Lilly and Novo Nordisk have sued medi-spas, clinics, and compounding pharmacies over counterfeit versions of their GLP-1 agonists.
Ultimately, we urge you to consider the following when deciding how to handle adjudicating GLP-1 agonist prescriptions for off-label use: “How much do you trust the PBM to act favorably to your pharmacy – now and in the future?” While the future of GLP-1 agonist audits is obscure, our guidance remains conservative – tread cautiously.
PAAS Tips:
Unveiling a Multi-Million Dollar Fraud and Kickback Scheme
According to an August 18, 2023 press release from the Department of Justice (DOJ), a pharmacy operations manager and some co-conspirators have pled guilty to committing healthcare fraud and to paying illegal kickbacks for Medicare and Medicaid claims that were never dispensed to patients. The two pharmacies in New Jersey and New York, now closed, operated as “specialty pharmacies” processing expensive medications to treat Hepatitis C, Crohn’s disease, and rheumatoid arthritis.
The pharmacies in question obtained retail contracts with several PBMs, which allowed them to receive payment for the specialty medication claims that were falsely billed. In order to increase the number of prescriptions being filled, bribes were paid to doctors and their staff to steer prescriptions to their pharmacies. Some of the bribes were expensive meals, cash, checks, wire transfers and paying an employee to work inside a doctor’s office. While the pharmacies usually dispensed the initial prescriptions to the patients, they billed for refills of these same medications without ever dispensing them to the patients.
For five years, the pharmacies received tens of millions of dollars for claim reimbursement from Medicare, Medicaid and private insurances that were not only never dispensed, but never even ordered from their wholesaler. The PBMs began to investigate by conducting routine audits for these “specialty pharmacies.” One of the co-conspirators told employees to falsify records by forging shipping documents to make it appear as if the medications were being shipped to the patient when they were not. The conspiracy to commit healthcare fraud has a maximum sentence of ten years in prison and the conspiracy to pay illegal kickbacks has a maximum of five years in prison. Both counts face a $250,000 fine, or twice the gross gain or loss from the offence, whichever is greatest.
Ensure your pharmacy has a robust Fraud, Waste and Abuse Compliance Program in place for employees to understand the repercussions of violating laws and regulations such as the False Claims Act and the Anti-Kickback laws. Contact PAAS National® (608) 873-1342 for more information on PAAS’ FWA/HIPAA Compliance Program that is easy to set-up, web based and customized for your pharmacy.
Insufficient/Missing Clinical Notes Yield Audit Recoupments
PAAS National® analysts are seeing more prescriptions flagged for recoupment when insufficient or missing information is not verified with a valid clinical note. Nothing is more frustrating than having the validity of the clinical notes questioned by a PBM auditor because they are incomplete, but that is exactly what is happening!
Inevitably, pharmacies will receive prescriptions that contain missing elements or need clarification. To avoid a potential recoupment, clear documentation is essential.
PAAS recommends four elements for clinical notes:
PAAS Tips:
Auditors Become Increasingly Stringent on Quantity and Unit of Measure Appeals
You may recall the article Quantity Changes Cause Audit Appeal Trouble from the May 2023 Newsline. The article discusses how PAAS National® saw an increase in the number of discrepancies for “unauthorized” refills. Consider the excerpt,
“Unauthorized refills” are instances where a pharmacy dispenses a quantity of medication that exceeds the total written quantity of the prescription, whether that be in a single fill or over the lifetime of the prescription.
PAAS Tips:
Avoiding MedImpact Recoupments for Bypassing Plan Limits
Pharmacies receive many rejections while billing claims throughout the day. Paying attention to these rejection messages is key to avoiding audit recoupments, which may occur years later. One such rejection occurs when a pharmacy bills a claim that exceeds a plan limit. This can be due to:
Actions to consider including …
MedImpact has a history of recouping claims which have been rebilled incorrectly to bypass plan limits. PAAS National® has seen numerous audits on blood glucose test strips where a pharmacy attempted to bill the correct days’ supply, received a rejection stating they will only cover a certain number of test strips per month, then rebilled for that quantity and with a different days’ supply even though it is not mathematically correct. This makes it very easy for MedImpact to come back and audit the claim because they already saw the pharmacy put in one days’ supply, then rebilled for a new days’ supply after receiving a rejection (especially when it occurs within seconds of the first rejection). Audit results will often state, “Incorrect billing of the day supply in order to bypass system edits (or the PA process) is not acceptable. MedImpact will reverse this claim.”
These recoupments can be difficult to appeal. It is better to ensure you are entering the correct days’ supply based on the mathematical calculation of the directions and following plan rejections appropriately at the start of the claim than to try to appeal later.
PAAS Tips:
Documentation Deep Dive: Meeting Auditors’ Standards in DUR and SCC
PAAS National® frequently sees claims audited that contain a clinical drug utilization review (DUR) or submission clarification code (SCC), particularly from Express Scripts and Prime Therapeutics. Auditors are looking for proper documentation when these codes are used, but pharmacies are often unaware of what this should include.
When a claim is being processed, a DUR conflict message may appear as a warning to prevent potential patient harm. The pharmacist must be made aware of it so that they can use their professional judgement before dispensing the medication. These should not be automatically overridden without pharmacist input.
Once the pharmacist has reviewed the DUR conflict, they will determine the appropriate “professional service” and “result of service” codes. A full clinical note documenting the situation must then be recorded to prevent audit recoupment. Simply documenting the override codes used does not meet this criterion or provide the auditor with the explanation for why the override used was appropriate.
Inappropriate Documentation: HD/M0/1B
Appropriate Documentation: 01-01-2020/Verified with Dr. Jones they are aware this is a high dose/Told to fill prescription as is/Pharmacist’s initials
Claims billed with an SCC code require similar documentation. These are typically overrides done for situations like a vacation supply, lost or stolen prescription, or therapy change. The code used, the date, and the reason should be documented in these cases.
PAAS Tips:
All Pharmacies Face Medicare Part A vs Part D Billing Risks, Especially Combo Shops
Pharmacies that service long-term care (LTC) and assisted living facilities (ALF) as well as retail patients, known as “Combo Shops”, may not be aware of the potential recoupment risks from Medicare. PAAS National® wants to inform our members of these risks and how to best avoid them.
Many times, patients residing in long-term care or assisted living facilities have a temporary stay under Medicare Part A. A change in Medicare coverage status is typically linked to the patient’s admission and discharge dates from a hospital or skilled nursing facility (SNF) stay.
When a patient is covered under Part A, the facility providing the stay is paid for the medications, supplies, and services during the coverage period. This means Medicare Part D will not be responsible for claims billed during that time (Medicare won’t pay under Part A and Part D at the same time). CMS provides Part D sponsors a Long-Term Institutionalized (LTI) report on a quarterly basis. This information is utilized by the plan to identify any misbilled claims due to overlapping Part A coverage. Unfortunately, PBMs do not have the information at the point-of-sale to stop these claims from being billed inappropriately.
It is vital that pharmacies stay in constant contact with facilities prior to billing and delivering prescriptions to ensure there has not been any changes in patients’ Medicare coverage due to an admission. Medications that are delivered to facilities when a patient is “in-patient” (under a Part A stay) should be returned to the pharmacy until the Part A stay has ended. Claims can be billed once again to Part D the day after the last covered day of the Part A stay. Any sooner and the claim would face full recoupment – even if there’s only one day of overlap!
LTC and ALF claims are not the only ones at risk. Prescriptions billed for patients that are on a Part A stay (for use at home) would also fall under this risk. Families and facilities frequently request pharmacies to fill prescriptions in anticipation of discharge. This in theory is a great idea; however, if Part A has already paid for that patient on that day(s), Part D will not pay for duplicate coverage. While difficult to catch, imagine the scenario of a husband being in the hospital (under Part A) and the wife presenting to the pharmacy for prescriptions. Even if the prescriptions are routine refills, they are subject to full recoupment! If the spouse (or an authorized representative) mentions that the patient is in the hospital right now, and they’re on Medicare, you will want to ask more questions before dispensing.
PAAS Tips:
Best Practices for Financial Hardship Waivers
PAAS National® analysts have noticed an increase in PBM audits focusing on copay collection. These audits requested a copy of the pharmacies’ policies and procedures addressing copay collection and financial hardship.
In general, PBMs require that pharmacies collect copays at the point of sale and retain a “financial paper trail” to prove such collection took place. Pharmacies will be asked to provide check copies (front and back), credit card receipts with authorization numbers and bank deposit slips as evidence of receiving cash from patients. Pharmacies may also be required to provide Accounts Receivable balances and Coordination of Benefits billing information, where applicable.
If patients are unable to pay their copay and the pharmacy waives or discounts the copay due to financial hardship, then you must have a robust written policy explaining the details on how such a policy is operated.
In general, financial hardship policies should include the following:
Be aware that insufficient copay collection (or evidence thereof) is one of the leading causes of network pharmacy termination.
PAAS Tips:
PBM Audits: Letters to Patients for Prescription Verification
Pharmacies often see PBM audit letters requesting documentation to validate paid claims, but not very many see letters sent to their patients.
PBMs have increasingly conducted patient (and prescriber) verifications, in the form of letters sent, to validate claims billed by your pharmacy. These letters are often initiated as part of a PBM investigation where they are searching for fraud, waste, or abuse– if there are inconsistencies between the information provided by the pharmacy, patient, and prescriber this can be a sticky situation.
Letters to patients typically consistent of basic questions like:
Letters often include an itemized list of claims billed by the pharmacy where the questions may include:
Patients may fail to respond to these letters for a variety of reasons, including: not recognizing the PBM name (and afraid of a scam), not remembering the details (and are afraid to answer incorrectly) or not being able to respond (e.g., literacy issues or changes in address).
PAAS National® has received audits where PBMs will issue audit results to the pharmacy that include recoupments for patient denials of receipt or paying copay where the pharmacy has never been asked to provide signature logs or proof of copay collection – these unfair conclusions are drawn before the pharmacy has had a chance to provide objective evidence to defend themselves.
PAAS Tips:
Avoid the Creon® Chargeback Catastrophe by Following THIS Billing Rule
Creon® is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. Claims for these pancreatic enzymes find themselves on audits year after year, and the audit risk has just increased as …
With this change to the package labeling, pharmacies MUST be sure to bill and dispense all strengths of Creon® in quantities that correspond with a full bottle, or multiples of a full bottle. Claims billed for quantities not evenly divisible by the quantity in a full bottle are easy for a PBM’s algorithm to flag for audit. If audited, these claims will likely face a partial or full recoupment with very little chance of a successful appeal. One example of language explaining this discrepancy can be found in the Fourth Edition (Version 4.1) of the 2023 OptumRx® Provider Manual, which reads “OptumRx reserves the right to recover payment for claims dispensed outside the manufacturer’s FDA-approved storage and dispensing recommendations. Claims for products where the manufacturer’s original package is designed and intended to be dispensed to patients without repackaging due to stability and patient safety concerns, may be subject to review and recovery. Pharmacies are advised to follow FDA requirements.”
Claims billed for LTC patients or patients enrolled in a medication synchronization or medication packaging program are NOT EXEMPT from the FDA rules to store and dispense medications in their original containers. In other words, these medications should NOT be put in bubble packs, blister cards, BINGO cards, strip packaging, medication boxes, or other compliance packaging and must only be dispensed by the pharmacy in their original containers.
PAAS Tips: