Audit | PAAS National

PBM Prescription Validation Requests Rose Nearly 20% in 2022!

Prescription Validation Requests (also known as claim reviews) are becoming a more frequent occurrence with many PBMs. In 2022, PAAS saw an 18% increase year over year. Some of the reasons these claims get flagged include:

High dollar claims
High quantity to days’ supply ratios
NDC package size mismatched to quantity billed

While these requests are a nuisance, they can work to the pharmacy’s benefit. With the PBM looking at the claim prospectively (before payment is received), pharmacies can avoid incorrectly refilling medication if an error is detected. Conversely, if a pharmacy is not prompted to correct an error (when one exists) and the claim is refilled over the course of a year, the financial recoupments can be much greater upon audit. The frustration comes in when these claim reviews are repetitious, and false positives (i.e., no billing errors) – creating work for the pharmacy without the need for claim correction.

Below is a chart of the various PBMs conducting these prospective reviews and the details/nuances associated with each. OptumRx/EXL^® makes up the majority of these pre-claim reviews that members report to PAAS. OptumRx defines the Prescription Validation Request (PVR) in their pharmacy manual as follows:

Administrator conducts limited scope prescription validation reviews for quality assurance purposes (“PVRs”), which are distinct from and are not considered audits. PVRs are utilized to verify the accuracy and validity of prescription claim submissions. Claims are monitored daily for appropriateness and potential billing errors and selected for review prior to payment. Network Pharmacy Providers are typically contacted via fax or email and asked to provide photocopies of specific documents and records related to its claims submitted to Administrator.

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PBM	Title of Request	Days to Respond	Targeted Claims
Caremark^®	Concurrent Claim Review	3	Compounds, non-FDA approved products, injections
Express Scripts^®	Claims for Investigative Review	5	CII’s
Humana^®	Pharmacy Claim Validation Request	3 business	Potentially misbilled claims (Unusual quantity and days’ supply combination)
MagellanRx/Conduent	Claim Check verification review	7	High dollar (Emgality^®, insulin)
MedImpact	Pre-pay Claim Review	3 business	Potential billing errors (Unusual quantity and days’ supply, incorrect DAW code)
OptumRx/EXL^®	Validation Request	14 business	High dollar (Humira^®, Enbrel^®, insulin, inhalers)
Prime Therapeutics	Initial Documentation Request	2	High-dose insulin

While PBMs have fancy names for these requests, make no mistake: if it looks like an audit, you must submit documentation like an audit, and you get results (and recoupments) like an audit, it is an audit!

PAAS Tips:

Send the validation review request to PAAS National^® right away as these can often have short deadlines
- Include a copy of the prescription and your backtag for the date of service in question so that we can verify claim billing
Most requests do NOT require a signature log, but PAAS will confirm if required after reviewing your audit notice.
Often, these claims are very recent and sometimes have not even left the pharmacy
A response is required even if claim has been reversed
If a claim is recent (within) 30 days, and there is a billing error, the pharmacy can often correct the claim (if applicable)
If the PBM finds the claim to be accurately billed, the pharmacy will not receive any “results”
Even though these requests are not typically labeled as an “audit”, PAAS has seen PBMs deny payment on the claim and/or issue “results”
If the pharmacy received what looks like “results,” send to PAAS for guidance. The “results” may list an estimated overpayment amount which is often a consequence of external auditing entities not having real time claims access

XDEA Numbers Have Been NiXed…but Not the Training

When you are preparing for an audit, a PAAS National^® analyst has likely told you to ensure a prescriber’s Drug Addiction Treatment Act (DATA) 2000 Waiver ID, or XDEA number, is included on prescriptions for medications used to treat opioid use disorder along with their regular DEA number. Effective December 29, 2022, the date the Consolidated Appropriations Act of 2023 (“The Act”) was signed, the need for prescribers to have XDEA numbers to prescribe such medications has been eliminated.

Subsequently, on January 12, 2023, the DEA released an informational document. In it, they state their support regarding the policy reform, stating, “At DEA, our goal is simple: we want medication for opioid use disorder to be readily and safely available to anyone in the country who needs it [and] the elimination of the X-Waiver will increase access to buprenorphine for those in need.” The document goes on to state “going forward, all prescriptions for buprenorphine only require a standard DEA registration number” but cautions that state laws and regulations still apply.

The Substance Abuse and Mental Health Services Administration (SAMHSA) echoes the DEA’s sentiment, stating “all practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe buprenorphine for Opioid Use Disorder in their practice if permitted by applicable state law…”

Despite the X-Waiver no longer being mandatory, the Act did enact a new training requirement. In Chapter 6 of the Act is Section 1263 entitled “Requiring Prescribers of Controlled Substances to Complete Training”. It discusses ways to meet training requirements, such as prescribers completing no less than 8 hours of training on the treatment and management of patients with Opioid Use Disorder in a variety of settings. Currently, DEA and SAMHSA are working together to implement the new training requirement and state that this requirement will not go into effect until June 2023.

PAAS Tips:

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PBMs and third-party payors are often mute on these topics, leaving pharmacies guessing on appropriate actions (and corresponding audit risk)
- Comply with state and federal requirements for controlled substances
- For prescriptions written prior to 12/29/2022, ensure the XDEA number is present on the prescription
- If the pharmacy is filling/refilling a prescription written prior to 12/29/2022 and the provider did not have an XDEA number at the time, the prescription would likely be considered invalid by PBMs (and the DEA), and PAAS would suggest [conservatively] to get a new order from the provider

Beware: Caremark is Monitoring High Quantity Utilization and Atypical Dispensing Habits

Beyond traditional desktop, on-site, investigational or invoice audits, Caremark performs various compliance reviews. These compliance reviews may include:

Concurrent Claim Reviews (PAAS Audit Assistance members can see PBM Prescription Validation Requests Rose Nearly 20% in 2022 the February 2023 Newsline)
Medicare/Medicaid Claims Review
Telephone or Fax Inquires
Aberrant Practices and Trends (typically via a Breach Notification Letter)
Rx Claim Review

PAAS National^® has recently reviewed a second round of these Rx Claim Review notices from members. While new for Caremark, PAAS has identified multiple versions of the letter primarily focusing on two areas of concern:

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Dispensed quantities of medications that are significantly higher than the average fill size
1. Primarily seen with Diclofenac Gel 1%, Lidocaine 3% cream, Ketoconazole 2% cream and diabetic testing supplies (i.e., lancets, needles, strips, and syringes)
Atypical dispensing activity (e.g., disparate prescriber to pharmacy ratio)
1. Primarily seen with Duexis^® and Pennsaid^®

The brief, and poorly worded, letter states the pharmacy should evaluate the claims in question and consider whether the dispensing of these medications is appropriate. It concludes with “your cooperation is appreciated and will greatly assist us in our review”. Due to the ambiguous direction, pharmacies are unsure if they need to respond or provide any additional information or documentation to Caremark.

PAAS Tips:

The notices PAAS has reviewed do not require a formal response
Caremark wants the pharmacy to evaluate the claims
- For claims listed as having a high quantity utilization, pharmacy can verify the quantity and days’ supply dispensed for appropriateness
- For claims listed as having atypical dispensing habits, pharmacy should validate the claims are billed under the correct prescriber, that there is a valid physician-patient relationship, and that the prescriptions are not being solicited
Every pharmacy’s situation is different and PAAS can help provide perspective and next steps
See Caremark Expands “Aberrant” Language & Restricts Bulk Purchases from February 2022 Newsline for additional information on Aberrant Practices and Trends

Valid Prescriber/Patient Relationships and Marketing Concerns

With the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) recent focus on telemedicine fraud, pharmacies may be wondering what their obligations are when determining a prescription’s authenticity – especially when it comes to whether a valid prescriber/patient relationship exists. Many PBMs, including Express Scripts, TRICARE, CVS Caremark, and OptumRx all have language in their provider manuals placing the responsibility on the pharmacy of ensuring a valid prescriber/patient relationship exists.

How can you determine if a prescriber/patient relationship is valid? Questions you may ask to verify this are:

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Does the patient regularly see this prescriber?
Does the patient live in the same area where the prescriber’s office is located?
Would you be able to obtain medical records to validate this relationship if needed?
Can you confirm the patient is aware of and requested the prescription?

Along with telemedicine, PBMs are also concerned about marketing practices of pharmacies. The provider manuals for Express Scripts, TRICARE, CVS Caremark, OptumRx, and Elixir all contain language surrounding what is not allowed and some, like Express Scripts, are known for using investigational audits to ensure compliance.

Prohibitions on certain marketing practices in these manuals include, but are not limited to:

Acquiring potential patients, either directly or from a third-party by referral, using door-to-door, telephonic or other cold-call tactics.
Obtaining the patient’s provider or billing information without the patient’s consent.
Using fraudulent, abusive, or deceptive television or internet advertisements or emails.
Contacting a patient or prescriber without a previously existing relationship.
Contacting or offering to contact a prescriber on a patient’s behalf without the patient’s express knowledge and authorization.
Obtaining a prescription from a prescriber by suggesting to a patient that the prescriber or patient’s health plan wants the patient to receive the medication without the prescriber’s knowledge and authorization.
Limiting a patient’s right to use a different pharmacy of the patient’s choice or use marketing techniques that may make a patient believe they are restricted to your pharmacy.

Pharmacies must remain vigilant and always conduct marketing practices in a manner consistent with their state laws, federal laws, and Medicare regulations and guidelines.

PAAS Tips:

Make every effort to confirm a patient authorized prescriptions coming from unusual prescribers
- Consider, amongst other things, the prescriber’s scope of practice and location to patient/pharmacy
Know your state and federal laws surrounding marketing practices
See the Medicare Communications and Marketing Guidelines for specific guidance
Develop policies and procedures surrounding marketing practices to ensure compliance
See the following Newsline articles for additional tips:
- November 2022 article, OIG Telehealth Fraud Concerns, for information on the OIG report
- November 2021 article, Telemedicine Audits: Are Your Prescriptions Legitimate?
To get started with your customizable FWA and HIPAA Compliance program contact PAAS National^® today, (608) 873-1342 or info@paasnational.com.

Natesto^® Nasal Gel Pump – Bill It Right!

Pharmacies have begun to see more prescriptions for Natesto^® (testosterone) nasal gel. Natesto^® is indicated for primary hypogonadism and hypogonadotropic hypogonadism, whether those conditions were congenital or acquired. At this time, it is not approved for age-related hypogonadism or for male patient populations less than 18 years old.

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NDC

NCPDP Billing Unit and

Package Size

Number of Actuations

in Package

Sprays Per Day

42667-5511-01

7.32 gm (Tube)

60

6

The recommended dose is 11 mg of testosterone (5.5 mg testosterone per nostril actuation) three times daily, preferably at the same time daily. Therefore, each package should be billed as a 10 days’ supply and a quantity of three packages would be dispensed for a 30 days’ supply, if prescribed as such. Despite needing to prime prior to initial use, no priming is necessary for the remainder of use and priming does not need to be factored in when computing the billed days’ supply.

PAAS Tips:

Natesto^® is a Schedule III controlled substance. Ensure the hard copy is adherent to both your state and DEA requirements
Prescription should contain specific dosing, including indicating “in each nostril”, and frequency of use
Despite the package indicating “total contents: 11 g/ dispenser”, ensure your computer system accurately reflects the proper NCPDP billing unit and package size
Reference the PAAS Nasal Inhalers chart on the PAAS Member Portal

The Ballad of Snowbirds and Audits

The winter months have many pharmacies mailing prescriptions to their snowbird patients who leave their northern nests for more hospitable climates. Pharmacies want to keep these patients happy and coming back when the weather is nicer and may look to mailing maintenance medications to them when they have migrated out of state. Although these pharmacies may think they are doing the right thing for patient care, and their business, they may also be setting themselves up for audit failure.

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Unfortunately, this does not just apply to northern states with snowbird patients. Many states now have laws that require nonresident pharmacies to obtain a license to ship, mail, deliver, or dispense prescription medications into their states. Auditors take advantage of these laws to recoup money from well-meaning pharmacies who may not even know that mailing a prescription out of state is a problem! For pharmacies situated close to the state border, delivering into a neighboring state carries the same risks. PAAS National^® has seen these claims cited as law violations with limited appeal options.

PAAS Tips:

Before mailing/delivering prescriptions out of state, it is a good idea to check with that state’s Board of Pharmacy to see if there are any licensure requirements for doing so.
Be aware of your contract obligations and which PBMs do not allow mailing of prescriptions to patients.
The COVID-19 pandemic had many PBMs make concessions to allow mailing during the Public Health Emergency (PHE). Keep up to date on concession expirations by downloading the PAAS COVID-19 PBM/Payers Concessions Chart.
Ensure you can prove, on an audit, the patient received their medication with tracking information that links to the prescription. See the January 2022 Newsline article, Mailing Prescriptions: How Do You Prove Patient Receipt?
Know the rules surrounding automatic mailing, especially for Medicare Part D patient, and review the September 2022 Newsline article, Automatic Mailing for Part D Patients, for specific information.

Start of New Year = Opioid Plan Rejects

PAAS National^® analysts receive numerous calls at the start of the new year looking for guidance on opioid plan rejects. With the new year, many patients may be on a new Medicare Part D plan. Opioid prescriptions processed previously with no issues, may now reject at point-of-sale on the new plan.

With the opioid crisis on the rise, CMS acted in 2018 to closely monitor opioid use and safety of patients. Medicare Part D plans were required to implement opioid policies and work together with patients, prescribers, and pharmacies with this monitoring. These policies included real-time safety alerts at the pharmacy’s point-of-sale.

Here are the four Medicare Part D opioid safety alerts:

Seven-day supply for opioid naïve patients
Exceeding maximum dose of morphine to 90 MME (morphine milligram equivalent), including cumulative dosing
Concurrent use of opioid and benzodiazepine
Optional alert can be implemented by plan for cumulative opioid daily dose of 200 MME

In August of 2022, CMS through the Medical Learning Network (MLN) published A Prescriber’s Guide to Medicare Prescription Drug (Part D) Opioid Policies. This guide offers guidance to both prescribers and pharmacies for patients using opioid medications. Pharmacies should note, alerts that cannot be resolved at point-of-sale may require providing patients with a copy of the CMS-10147 Medicare Prescription Drug Coverage and Your Rights form. This form provides instructions for patient to work with their prescriber and their Medicare plan to expedite coverage for their medication.

Pharmacies have an obligation to

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follow plan alerts and guidelines for the safety of patients. Bypassing these restrictions not only put claims at risk of recoupment, but further scrutiny of your controlled substance dispensing practices. Split billing opioid prescriptions (i.e., billing part to insurance and cash payment for the remainder) is considered bypassing. When claims are not accurately billed to the Medicare D plan, proper monitoring cannot be done. PAAS does not recommend pharmacies split bill prescriptions to resolve rejects.

PAAS Tips:

Call plan for overrides or prior authorization when appropriate
Consult with prescribers about safety alerts and possible resolutions, e.g. changing medication or completing prior authorization paperwork
Prescribers unwilling to work with the pharmacy could be a red flag for the clinical appropriateness of their prescribing
PBMs can monitor and flag prescriptions that bypass plan limits
Charging the patient cash and not submitting claims could be considered non-compliance with the provider manual and could lead to network termination
Involving the patients in the resolution process may be necessary
See the CMS Medicare Part D Opioid Policies: Information for Pharmacists

Update: Medicare Part D Mandatory E-Prescribing Requirements for Controlled Substances – Final Rule

In our December 2021 Newsline article, PAAS National^® alerted pharmacies to the delay in enforcement of Electronic Prescribing for Controlled Substances (EPCS) for Medicare Part D until January 1, 2023. CMS has finalized policies in the Calendar Year (CY) 2021 Physician Fee Schedule (PFS) and CY 2022 PFS Final Rule for requirements on EPCS shown in section 2003 of the SUPPORT Act. Notably, in the CY 2022 PFS final rule, CMS finalized four proposals related to EPCS:

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1. Compliance Action (Enforcement) Extension

Delayed enforcement on prescribers to no earlier than January 1, 2023
Prescribers prescribing for beneficiaries in LTC facilities were extended to January 1, 2025.

2. Electronic Prescribing Controlled Substance Percentage

At least 70 percent of a prescriber’s Schedule II-V controlled substance prescriptions must be electronically prescribed, except in cases where there is an exception or waiver in place.

3. Finalized Proposals to the Classes of Exceptions (as outlined by section 2003 of the SUPPORT Act)

For prescriptions issued where the prescriber and dispensing pharmacy are the same entity
For prescribers who issue <100 controlled substance prescriptions for Part D drugs per calendar year
Prescribers located in the geographic areas of an emergency or disaster
Prescribers who have received a CMS-approved waiver due to circumstances beyond the prescriber’s control

Note: there were no exemptions approved for prescribers issuing prescriptions to nursing facility patients (despite the delayed enforcement) nor hospice patients.

4. Limit compliance actions to sending a notice of non-compliance

During the CY 2023 if CMS believes the prescriber is violating the EPCS requirement.

The CY 2023 PFS Final Rule expands about this notice of non-compliance by clarifying two components. That CY 2023 compliance with EPCS requirements will be based on CY 2023 PDE data, that will not be evaluated until late CY 2024. Consequently, the non-compliance notice enforcement action has been extended through CY 2024. With CY 2025, CMS is planning more burdensome penalties that would apply to non-compliant prescribers.

PAAS Tips:

CMS will begin monitoring prescribers for EPCS starting in 2023 and continue through the end of 2024
If a prescriber is found to be non-compliant during the 2-year monitoring process, CMS will begin sending notices of non-compliance beginning in 2024
There are exceptions and waivers in place, noted above
Section 2003 of the SUPPORT act makes it clear that the EPCS requirement should not be construed as requiring a pharmacist to verify that a practitioner, with respect to a prescription for a covered Part D drug, has a waiver from the EPCS requirement under Part D
CMS is evaluating what the penalties will be for non-compliance and will start issuing those penalties 1/1/2025
Encourage non-compliant prescribers to register and attend the Introduction to the CMS EPCS Program Webinar hosted by CMS on January 12, 2023 from 1:00 – 2:00 pm ET to learn more information

FDA’s Guidance on Compounding Commercially Available Products in Short Supply

For various reasons, including ingredient shortages or manufacturer back orders, a pharmacist may be required to compound a commercially available product. This is currently the case for Amoxicillin Oral Powder for Suspension, as evident from the FDA’s Drug Shortage List. As a result of this shortage, the FDA released Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act which was put into effect immediately due to the urgency of the situation, stipulating their guidance as nonbinding recommendations (not legally enforceable), except in cases where there are regulatory requirements that pharmacies must meet.

Products compounded by pharmacies are not FDA-approved and must follow Section 503A of the FD&C Act. Under Section 503A, leeway is given to pharmacies in that they do not need to meet specific requirements stated in the FD&C Act, namely new drug approval or current good manufacturing practice requirements. However, pharmacies are only allowed to compound a commercially available product if

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“each drug product [is] compounded for an identified individual patient based on the receipt of a valid prescription order…approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient.” While there is some leniency for anticipatory compounding under certain circumstances, we would encourage pharmacies to review FDA’s Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry prior to doing so. Additionally, when pharmacies identify a need to compound a prescription that is written for an unavailable commercial product, pharmacies must get approval from the prescriber and make a clinical note on the prescription hardcopy.

Although the FDA memo references beta-lactams only, being mindful of this guidance is helpful with any commercially available compounded product that a pharmacy makes, including oseltamivir (Tamiflu) suspension. Tamiflu suspension is not currently listed on the FDA’s Drug Shortage List, but pharmacies nationwide have been struggling to get the product from their wholesalers. So, what are pharmacies to do in order to be best protected in case of an audit?

PAAS has received numerous prescription validation requests, specifically from Caremark, for compounded Tamiflu prescriptions, looking for proper compounding and billing practices. For good measure, consider attaching a screenshot of your wholesaler(s)’ website showing proof the commercially available product was not available on or around the date of compounding, or a copy of your purchase order reflecting a product was unavailable to be shipped. Ensure the date, NDC, drug name, and inventory outage is visible. The longer you can prove that an ongoing shortage of a product exists, the better your situation becomes in the event an audit questions the continuous need to compound. We do not believe this is necessary for products listed on the FDA’s Drug Shortage List, but documentation to that effect on the prescription would be prudent regardless.

In addition, consider the following PAAS National^® Tips when in the situation where compounding a commercially available product is necessary.

PAAS Tips:

Reference the FDA’s Drug Shortage List. If the product is listed, print off and attach to hard copy.
Reference package insert to inquire if there is a predetermined method to compound products, as seen within Tamiflu’s package insert.
Check with your state’s board of pharmacy or Medicaid to inquire if any concessions or guidance has been given regarding drug shortages.
PBMs do not pay for waste, unlike suspensions that are reconstituted. Compound the exact amount needed to complete the therapy.
Follow proper compounding billing and documentation processes, outlined in the November 2021 Newsline article, Self-Audit Series #10 – Compound Prescriptions.