LIVE WEBINAR MAY 4th: Audit Preparation for the End of the Public Health Emergency

Join President of PAAS National®, Trenton Thiede, PharmD, MBA for a LIVE webinar “Audit Preparation for the End of the Public Health Emergency ” on May 4, 2023 from 2-2:45pm CT as he discusses:

  • The anticipated Amendment to the Declaration under the PREP Act
  • Onsite audit preparations
  • Audit considerations with mailing and delivery medication
  • Elements for compliant delivery/signature logs
  • New Continuous Glucose Monitor (CGM) requirements that will affect Medicare B patients

We will allow for some Q&A at the end of the webinar. If you would like to submit questions prior to the webinar, please click here.

PAAS Audit Assistance members will have access to a recording on the PAAS Member Portal if they are unable to attend the live event.

REGISTER TODAY!

Best Practices: Medication Delivery

With the Public Health Emergency (PHE) for COVID-19 ending May 11, 2023, a return to pre-pandemic requirements for proving patient receipt of medications is anticipated. Many pharmacies have gotten into the habit of leaving medications at the door or in the mailbox for patients over the last three years and noting “Impacted by COVID-19” in place of a signature. Unfortunately, some pharmacies have run into problems with this procedure during audits due to patients deny ordering and/or receiving these medications. In some instances, the patient passed before the medications were delivered.

Review the PAAS Tips below to see what pharmacies can do to avoid audit problems when delivering medications.

PAAS Tips:

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  • Always obtain and document patient consent prior to delivery of any auto-refilled or synchronized medications and provide a minimum of two reminders before each fill. See Automatic Mailing for Part D Patients from our September 2022 Newsline.
  • Coordinate the delivery when the patient or a representative would be home to accept the delivery.
  • Use extra caution when delivering medications for controlled substances, especially if outside the norm or being requested by a different family member.
  • Do not leave medication at the door or in the mailbox without obtaining a signature.
  • Without getting a patient signature, you do not know if the patient actually received their medication.
  • A picture of the package at the front door does not prove what was inside the package, nor does it prove where the package was delivered without a geotag on the picture.
  • If the pharmacy and patient have agreed to the risks of leaving a package in a mailbox or at the front door, the pharmacy should include a PAAS Trifold Mailer with a detailed description of the medications delivered for the patient (recipient) to complete and mail back.
  • Signature logs for delivery should also include a handwritten date received.
  • Auditors interpret preprinted dates as the date the delivery manifest was generated, not necessarily the date of actual receipt by the patient.
  • Point of sale (POS) signature logs for delivery must be monitored to ensure the actual date of receipt is recorded. Work with your software vendor to know your system’s capabilities.
  • OptumRx only allows delivery by W-2 employees.
  • If delivering out of state, make sure you hold a non-resident pharmacy license for that state.
  • Read the February 2023 Newsline article, Are Your Delivery/Signature Logs PBM Compliant for 2023? for more information.

Prepare Yourselves! Onsite Audits Are Coming in Strong

Health and Human Services (HHS) is planning for the public health emergency (PHE) to expire on May 11, 2023 and PBM auditors are in full swing of resuming their onsite visits. Onsite audits have always been the most aggressive and highest risk to community pharmacies. PAAS National® saw a 300% increase in onsite audits in just the 3rd Quarter of 2022 and they continue to be on the rise! PAAS analysts have years of experience helping our members navigate through preparation for an onsite audit. We are available to assist you throughout your audit process starting with, How to Prepare for an Onsite Audit.

Your PAAS analyst can provide pre-audit consultations, helpful tips and tools, reminders on state law requirements, and discuss current PBM trends. Our Onsite Credentialing Guidelines document has been created specifically to help pharmacies be ready for questions the auditor may ask during their visit. This tool is updated frequently to provide members the most up to date information along with providing PAAS National® FWA/HIPAA Compliance members reference to locate specific policies in their customized FWA/HIPAA Compliance Policy & Procedure Manual.

PAAS Tips:

Contact PAAS National® (608) 873-1342 today to get your customized FWA/HIPAA compliance program! Or schedule a service overview of the program to see why it was designed to meet CMS’ seven core elements required to adopt and implement an effective compliance program.

A Documentation Checklist for Continuous Glucose Monitor Claims

For any item to be covered by Medicare B, there must be clinical documentation to support the covered diagnosis, prove it is reasonable and necessary for treatment and meet all other Medicare requirements. While the Local Coverage Determination (LCD) outlines billing and documentation requirements specific to each DMEPOS item, and the DME MACs created documentation checklists for each DMEPOS item, they tend to be verbose and difficult to read. Additionally, during the COVID-19 PHE, CMS expressed enforcement discretion on clinical indications for Continuous Glucose Monitors (CGM). Prescribers, and pharmacies, only needed to make sure the medical record reflected the equipment furnished to patients was reasonable and necessary. The LCD for CGMs was updated 3/2/2023 with an effective date of 4/16/2023, although the enforcement discretion seemingly coincides with the end of the PHE on 5/12/2023. The CGM checklist listed below can help suppliers in adhering to all of Medicare rules in simplified terms.

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  • CGM Initial Coverage Requirements – to be eligible for coverage of a CGM and related supplies, the beneficiary must meet all of the following initial coverage criteria (1) – (5);
  1. The beneficiary must have diabetes mellitus
  2. The beneficiary’s treating practitioner has concluded that the beneficiary or their caregiver has sufficient training using the CGM prescribed as evidenced by providing a prescription for the CGM
  3. The CGM is prescribed in accordance with FDA indications for use
  4. The beneficiary for whom a CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:
    1. The beneficiary is insulin treated
    2. The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following:
      1. Recurrent (more than one) level 2 hypoglycemic events (glucose <54 mg/dL (3.0 mmol/L)) that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or,
      2. A history of one level 3 hypoglycemic event (glucose <54 mg/dL (3.0 mmol/L)) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia
    3. Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person or Medicare-approved telehealth visit with the beneficiary to evaluate their diabetes control and determined that criteria (1)-(4) above are met.
  • CGM Continued Coverage Requirements – every six (6) months following the initial prescription for the CGM, the treating practitioner must have an in-person or Medicare-approved telehealth visit with the beneficiary to document compliance to their CGM and diabetes treatment plan.

If any of the initial coverage criteria (1)-(5), or the continued coverage criteria are not met, the CGM and related supply allowance will be denied. Claims for a Blood Glucose Monitor (BGM) and their related supplies that are billed in addition to a non-adjunctive CGM and supply allowance, will also be denied.

  • Medical Records

For a beneficiary who exceeds the usual utilization amounts of BGM supplies, there must be adequate information in their medical record to determine that:

  1. Treating practitioner has had an in-person or Medicare-approved telehealth visit to evaluate the management of diabetes
  2. The specific quantities of supplies ordered are reasonable and necessary
  3. Narrative statement that documents the frequency at which the beneficiary is testing or a copy of their testing logs

Medical records must support criteria (1-4) above regarding CGM initial coverage and (4B) – document the beneficiary has a history of problematic hypoglycemia consistent with one of the following pathways to coverage:

  1. Beneficiaries with non-insulin treated diabetes and a history of recurrent (more than one) level 2 hypoglycemic events
    1. The treating practitioner must document at least one of the following in the medical record for each event:
      1. The glucose values for the qualifying event(s) (glucose <54 mg/dL (3.0 mmol/L)); or, Classification of the hypoglycemic episode(s) as level 2 event(s); or,
      2. Incorporate a copy of the beneficiary’s BGM testing log into the medical record reflecting the specific qualifying events (glucose <54 mg/dL (3.0 mmol/L)); and,
    2. Documentation of more than one previous medication adjustment and/or modification to the treatment plan (such as raising A1c targets) prior to the most recent level two event
    1. Beneficiaries with non-insulin treated diabetes and a history of at least one level 3 hypoglycemic event
      1. The treating practitioner must document at least one of the following in the medical record:
        1. The glucose value for the qualifying event (glucose <54 mg/dL (3.0 mmol/L)); or,
        2. Classification of the hypoglycemic episode as level 3 event; or,
        3. Incorporate a copy of the beneficiary’s BGM testing log into the medical record reflecting the specific qualifying event (glucose < 54mg/dL (3.0 mmol/L)); and,
      1. An indication in the medical record that the beneficiary required third party assistance for treatment.

Whether an in-person or Medicare-approved telehealth visit, the medical record must support the beneficiary continues to adhere to their diabetes treatment plan and use of the CGM device.

Express Scripts Provider Manual – 2023 Updates

All PBMs update their Provider Manuals at regular intervals and Express Scripts (ESI) is no exception. Express Scripts released an updated version of their Provider Manual in January 2023 and provided a “summation of changes” document for network pharmacies that provides a brief description of the changes and where in the Provider Manual the change occurred. Here are important changes that may impact audits:

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  1. Section 5.2 Compliance Checks (revised)
    1. ESI has modified the items that may be requested during a Compliance Check
    2. ESI performs “compliance checks” which are unannounced onsite audits that involve observations of pharmacy to ensure compliance with the contract as well as laws, rules and other regulations. These visits do not include review of prescriptions but notably do review “other pharmacy records” like written policies and procedures and FWA compliance documentation. We have also seen auditors request to see your refrigerator, will-call bins and inventory stock shelves.
  2. Section 5.4 Overbilled Quantity discrepancy (revised)
    1. ESI has modified the definition of the “Overbilled Quantity” discrepancy.
    2. An example of an overbilled quantity could be submitting an incorrect day supply to circumvent a ‘needs prior authorization’ reject message.
    3. A recent audit example was a prescription for diabetic test strips quantity #200 and sig of test 10 times daily and claim rejects when billed as a 20-day supply so pharmacy changes to a 30-day supply to get a paid claim rather than pursue prior authorization.
  3. Section 5.11 Copay Collection (revised)
    1. ESI has added additional language under the Copayment Collection section to specify that they may request check copies, credit card transaction records and point of sale receipts to confirm copay collection.
  4. Section 5.11 Prior Authorization (revised)
    1. Pharmacies that provide assistance to prescribers in completing prior authorizations must have written authorization on file and this documentation is subject to audit review.
  5. Section 5.11 Valid Claim Submission (new)
    1. ESI has added this new section that spells out pharmacy responsibility to ensure that all claims information submitted is accurate and complete and only submitted in accordance with a valid prescription. Claims submitted without a prescription (e.g. “test claims”) may result in recoupment or network termination.
  6. Section 5.12 Fraud, Waste, and Abuse Investigations of Network Providers (new) and Section 5.13 Dispute Resolution for Fraud, Waste, and Abuse Investigations of Network Providers (new)
    1. ESI has added these new sections to differentiate “investigations” from “audits”
    2. PAAS National® often sees multiple rounds of document requests before investigations are concluded
    3. Investigations often include inventory evaluations and outreach to patients or prescribers to corroborate information gathered directly from pharmacy
    4. Pharmacies may appeal final results within 30 days
    5. State audit laws may be more easily circumvented when reviews are labeled as investigations rather than audits

PAAS Tips:

Black Market HIV Medications Are Not Worth the Savings!

According to a statement released by the U.S Attorney’s Office in the Southern District of New York, five individuals were arrested the morning of March 2, 2023 as a result of defrauding government insurance plans, including Medicaid and manipulating low-income individuals out of their HIV medications from July 2020 through February 2023. This resulted in $15 million worth of illegitimate payments to the pharmacy from government insurance plans. Instead of purchasing the HIV medications through accredited distributors, the pharmacy opted to buy HIV medications from the black market, totaling over $6 million worth of purchases.

In the fraud scheme, an individual sold the black-market HIV medications to a pharmacy store owner with two pharmacy locations in Bronx, New York. He subsequently dispensed the black-market medication to patients with HIV in addition to submitting fraudulent insurance claims for profit. The other three indicted individuals were employed by the pharmacy and assisted the pharmacy owner in paying illegal kickbacks to incentivize patients to use their pharmacy for their HIV medications. To make matters worse, the pharmacy team encouraged patients to sell their HIV medications back to the pharmacy, foregoing the treatment meant to control their HIV infections. The five individuals are looking at time in prison varying from 27 to 47 years if sentenced to the maximum.

Although this is a case that shows blatant intent of actions, the basis still applies:

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  • Properly vet your wholesalers
    • Utilize NABP’s website to check for Drug Distributor Accreditation
    • Review the FDA’s website to see which wholesalers are licensed by your state
    • Be familiar with the Drug Supply Chain Security Act, or the Track and Trace law, and ensure your pharmacy utilizes wholesalers who can provide pedigrees
    • Get additional tips in the following Newsline articles pertaining to vetting wholesalers and distributors
    • Ensure claims are being adjudicated in accordance with a prescription
    • Have your pharmacy team complete their Fraud, Waste, and Abuse Training annually to ensure your team appreciates the repercussions of fraud, waste and/or abuse of medications

PAAS’ Fraud, Waste & Abuse and HIPAA Compliance program keeps members compliant beyond training and exclusion checking. If you aren’t a member of FWA/HIPAA and are interested in saving $129 on your membership, please contact PAAS at (608) 873-1342.

Be On the Lookout for Prescription Reversal Requests from Humana

Humana periodically performs retrospective claim reviews. If upon review Humana determines a claim was billed in error (i.e., after the Humana coverage was terminated), the pharmacy will get a prescription reversal letter. The reversal letter will include a claim detail report listing the claims and dates of service for member(s) who no longer had coverage with Humana at the time the claims were billed. Please see the PAAS Tips below for guidance on what steps to take if your pharmacy receives one of these prescription reversal requests.

PAAS Tips:

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  • Do NOT reverse the claim prior to performing an investigation
  • Make a good faith effort to call the patient and see if they have other insurance
    • If yes, try to rebill the claim with the insurance information provided by the patient
    • Only if the new claim is paid in full should the pharmacy reverse the original Humana claim and sign the form to send back to Humana
    • If the patient does not have other coverage for that date of service, or the pharmacy gets a rejection when trying to bill the new coverage, send a note to Humana per the guidance provided in the letter. You can also include a print screen of the rejection
  • Do not sign the claim detail report as Humana may interpret your signature as an approval to reverse the claim
  • Push back that the claim was adjudicated at the point of sale. If Humana would have had the coverage termination date populated correctly, the claim would’ve rejected at that time
  • Reiterate that you do NOT give Humana authorization to reverse the claim(s) in question
  • Write up a statement that the pharmacy made a good faith effort to contact the patient for additional coverage on that date(s) of service and the pharmacy should not be held liable for Humana’s error

Nuedexta® National Audit: A Tale of Medically Accepted Indications

PAAS National® stresses the importance of medications being prescribed for a medically accepted indication (MAI), particularly for Medicare, Medicaid and Tricare, as this carries an audit risk that is difficult to overturn on appeal. Nuedexta®, a medication approved for the treatment of Pseudobulbar Affect, or PBA, underwent a national audit conducted by Centers for Medicare & Medicaid Services (CMS) and Plan Program Integrity Medicare Drug Integrity Contractor (PPI MEDIC). PBA disorder is a neurological condition that results in an individual experiencing “emotional lability”. However, the FDA chose to use a more specific definition of PBA when determining Nuedexta®’s MAI. According to Section 1 – “Indications and Usage” in the package insert, it states “PBA occurs secondary to a variety of otherwise unrelated neurologic conditions…” and is a “specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.”

CMS’ desire to conduct a national audit was substantiated by the fact that in September 2019, Avanir Pharmaceuticals, Inc., the manufacturer of Nuedexta®, paid over $95 million to the Department of Justice (DOJ) to resolve allegations of kickbacks and false or misleading marketing efforts that lead to long-term care patients being prescribed Nuedexta® outside of the MAI. Therefore, the goal of the Nuedexta® National Audit was to assess for fraud, waste, and abuse associated with the medication in addition to the risk the medication poses if not used in a clinically supported manner.

From January 1, 2019 through December 31, 2020, select plan sponsors were asked to submit prescription drug event (PDE) documentation that would substantiate their coverage of Nuedexta®. According to the results, CMS agreed with most of the prior authorization parameters put in place by plan sponsors. In the instances that documentation was improper, CMS had plan sponsors address their process that resulted in Nuedexta® being covered inappropriately, such as relying on patients’ historical medical claims or information from prior coverage requests instead of clarifying Nuedexta®’s intended use with prescribers or denying prior authorization requests on the basis of non-MAI uses. In conclusion, CMS is requesting all plan sponsors to evaluate their coverage and payment of Nuedexta® based on their formulary and utilization management edits in place, to prevent Nuedexta® from being used outside of its MAI.

PAAS Tips:

  • Be mindful of a medication’s indication for patients on government sponsored health plans to ensure you are lowering your risk for audit
  • Use pharmacist drug utilization reviews to your advantage to ensure medication is being used properly. Do not disregard or bypass system flags without due diligence.

Discount/Cash Cards Are Disruptors in the Industry

NCPA Multiple Locations Conference Panel Discussion Part 1 of 2

On February 25, 2023, President of PAAS National®, Trent Thiede, had the privilege of participating in a Panel Discussion entitled Marketplace Prescription Dynamics Sure to Shape Your Business Strategies. While traversing several different topic areas, there are two core issues that are important for PAAS members: discount/cash cards and biosimilar adoption in 2023.

IQVIA published a white paper entitled Pharmacy Discount Card Utilization and Impact in August of 2022 with several interesting findings. Among them, discount card utilization has grown to 5.4% of all pharmacy adjudications in 2021, a 63% increase over 2017 – of which “Not So GoodRx” now represents 46%. Only 9% of discount card transactions are for branded products. For Medicare patients, nearly 1 in 5 (19%) used a discount card. Commercial patients were 12%, but that doubled to 24% for those with an observed deductible. Cash paying patients represented 56% of all patients, and 52% of transactions.

While the discount card growth has been remarkable, what makes them disruptors in the industry has been their impact on the traditional PBM model. Discount cards have been effective at undermining the perceived benefit that PBMs are supposed to provide (i.e., why is GoodRx able to offer a better price on my prescriptions than my insurance).  Additionally, patients’ out of pocket costs are typically not captured when they use discount cards unless a patient is going to submit claims on their own (in addition to gaps in adherence metrics and other quality measures). In response, Express Scripts announced a partnership with GoodRx to include a “lesser of” logic when processing prescription claims through their Price Assure program. Not to be outdone, OptumRx launched Price Edge which will review direct-to-consumer prescription drug prices and offer members the lowest available price. Comically, OptumRx said they currently offer the best price to their members about 90% of the time, meaning 10% of the time patients are getting a raw deal. Both of these programs are automatically including these drug purchases into member’s deductibles going forward.

Pharmacies know that discount cards are really just another form of spread pricing, benefiting the discount card provider and PBM. GoodRx reports that it earns 15% of the patient’s total retail prescription cost, and that doesn’t include a fee for the PBM processor. Interestingly, GoodRx had disclosed that Kroger had accounted for only 5% of participating pharmacies, but nearly 25% of prescription transaction revenue. How could it have been that high? As a chain, Kroger was more likely dutiful in their utilization and/or promotion of GoodRx for patients. Most independents despise GoodRx and will create work arounds to avoid utilizing the card (e.g., with aggressive cash pricing or price-matching). Pharmacies should always be careful not to jeopardize their usual and customary. With the integration from these new programs by the PBMs, bypassing discount cards will likely no longer be an option for insured patients. The impact on BER, GER and even DIR fees for 2023, and beyond, are not clear.

Speaking of jeopardizing your Usual & Customary pricing, Amazon’s RxPass should be a flop. If you haven’t heard or read about it, Amazon is offering their Prime members “eligible medications for one flat, low monthly fee of $5, and have them delivered free of charge”. Patients with Medicare, Medicaid, or located in one of the seven states they exclude are not eligible to participate. The broader question is how long it will take the DOJ and HHS-OIG to enforce the U&C issue that has already played out with Walgreens (and many others). PAAS previously illuminated the $60 million settlement with the Prescription Savings Club in a March 2019 Newsline: AVOID “Discount Clubs” for Cash Patients. That same DOJ announcement also discussed the infamous Insulin Pen Box Settlement for $200 million. Amazon clearly missed this settlement, as the PillPack subsidiary paid a $5.79 million settlement in May 2022 for the same insulin pen dispensing practices.

Stay tuned for our second core issue from the NCPA MLC panel discussion in the April 2023 Newsline where we’ll discuss biosimilar adoption, insurance coverage and audit risks.

Not-So-GoodRx Reprimanded $1.5 million for Sharing Consumers’ Information

The article GoodRx Shares Consumer Data appeared in the April 2020 Newsline, which pertained to GoodRx sharing their consumers’ data with various platforms, including Facebook and Google. Key information from the article include:

  • Both Facebook and Google denied utilizing information, specifically personal health information, obtained from GoodRx to target ads to mutual consumers.
  • Despite Facebook and Google’s claims, GoodRx did issue an apology for their role they played in sharing consumer information to the platforms and vowed to “do better”
  • Since GoodRx is “a private company with no doctors or hospitals involved, it does not have to protect the health data a consumer gives it”

One could speculate that GoodRx was hoping this would be the end of the ordeal. However, it was not.

For the first time, the Federal Trade Commission (FTC) has enforced the Health Breach Notification Rule, due to “GoodRx Holdings Inc…failing to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google, and other companies.” Pending federal court approval, the Proposed Order will include numerous provisions that GoodRx will need to follow, including:

  • Prohibited from sharing user health data with applicable third parties for advertising purposes
  • Require user consent for sharing health information outside of advertising purposes
  • Implement a privacy program which includes safeguards from unauthorized access to user data
  • Mandatory outreach to third parties requesting consumer health data be deleted and disclose information about the breach of their health information and FTC’s legal action to consumers
  • Limit the amount of time consumers’ health information will be retained
  • Make available to the public how long their information will be retained, what information is collected, and why the information collected is necessary
  • Pay a civil penalty of $1.5 million due to “sharing sensitive personal health information for years with advertising companies and platforms -contrary to its privacy promises…”.

As alluded to above, GoodRx is not a HIPAA covered entity and therefore not legally bound to the same notification rules as covered entities. As such, patients should be made aware of this if they choose to upload information into GoodRx’s app or website or request that a pharmacy submit claims information to GoodRx. Patients can refer to  GoodRx’s updated “Privacy Policy” for more information.