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.

Proof of Copay Collection – Secondary Payers Hidden in Plain Sight

If your pharmacy has not had to deal with proof of copay collection on an audit, your time is coming. More frequently, PBM auditors are comparing the copay amount on a point-of-sale receipt against the copay the PBMs expect based on the plan design and claim adjudicated. Copays are used by insurers to make patients aware of the cost of their medications and incentivize them to try less expensive alternatives. Waiving or discounting copays (unless permitted by law) or placing copays on a house account (with no intent to collect) are all fraudulent actions and may put your contract at risk.

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PAAS National® analysts are here to walk you through the documentation required to prove the pharmacy collected the copay. It is very important to show that the full copay amount was collected to avoid any accusations of fraudulent activity. Sometimes, it is very straightforward (e.g., the claim had one payer and the returned copay was collected via credit card payment, which is evidenced by providing a copy of the point-of-sale receipt); however, it is not always that simple. When a secondary payer modifies the copay, this causes the point-of-sale receipt to have an amount less than what the primary payer would expect. Identifying a secondary payer is often easy when it is Medicaid, a second insurance plan, or a manufacturer coupon, but one secondary payer is often overlooked – the eVoucher. This type of copay reduction is a discount applied during adjudication by your switch and is usually from the product’s manufacturer.

It is not always obvious to pharmacy staff when an eVoucher is applied, but if a PBM auditor asks for proof of copay collection, it will be obvious to them that the copay collected does not match the copay they expect. It is critical that pharmacies check claim data for this “hidden” secondary payer when proof of copayment collection is requested so evidence of how much the eVoucher lowered the copay can be provided to the PBM auditor. Information about how much the eVoucher covered may be found in the returned adjudication message (possibly found under the Electronic Data Interchange [Received] in your pharmacy software system).

If you would like to speak to an analyst about proof of copay collection concerns, call (608) 873-1342, email info@paasnational.com or submit a question online through the PAAS Member Portal.

PAAS Tips:

  • It is critical to provide PBM auditors with all the information related to proof of copay collection – this may include:
    • register or point-of-sale receipts
    • secondary payer coordination of benefits screen print
    • secondary payer plan information (e.g., BIN, PCN, ID, group number)
    • eVoucher data
    • payment information which may include the last four digits of the credit card used to pay the copay, a copy of the front and back of the patient’s check used to pay the copay and deposited at your bank, or even cash deposit slips to show copay paid in cash was fully collected
  • PAAS FWA/HIPAA compliance members can refer to Section 4.1.5 of their Policy and Procedure manual
    • This includes language for non-routine waivers for cost-sharing amounts imposed under a federal health care program
  • For additional information on proof of copay collection, review the following Newsline articles:

LTC Is Different … Do Auditors Agree?

PAAS National® analysts frequently assist pharmacies that service LTC facilities. Not only does PAAS work with many combo shops, but we also service numerous closed-door LTC pharmacies. The pharmacies servicing Skilled Nursing Facilities (SNFs) often struggle to provide the appropriate documentation that auditors look for. It is important to know most PBMs follow similar requirements for both retail and LTC during the audit process.

Three audit flags PAAS analysts frequently see for LTC pharmacies:

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  1. Missing a valid order/prescription (consider reviewing Humana Guidelines for LTC)
    1. Patient Name
    2. Date of issuance
    3. Name of the Drug
    4. Strength of the Drug
    5. Dosage form of drug (if applicable)
    6. Directions for Use

Some of more common items that are missed or a concern to refresh pharmacy staff on are:

    1. Quantity
    2. Duration of Therapy (number of refills or clear start/stop dates, or a disclaimer regarding duration)
    3. Missing DEA Elements on Controlled Substances
    4. Prescriber’s printed name and signature on the physician order
  1. Billing and dispensing at inappropriate times
    1. Delivering prior to Billing
    2. Delivering outside the PBM’s Return to Stock window
  1. Insufficient documentation for signature/delivery logs
    1. Patient name
    2. Prescription number(s)
    3. Date filled or fill number
    4. Date of delivery to facility – cannot be pre-printed
    5. Facility name and address
    6. Signature and date of representative accepting delivery
    7. Proof that full amount billed was received

While standard for retail pharmacies, those servicing LTC facilities may fall short. Pharmacies should consider putting procedures in place to mitigate these issues during the audit process. Trying to obtain this information at the time of the audit, or appealing post-audit, can be very difficult and time consuming.

PAAS Tips:

Proper Billing for Intermittent Use Medications

Calculating proper days’ supply on continuous use medications can be hard enough; how do PBMs and auditors view medications that are used intermittently?

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Simply put, the days’ supply billed should take into account the entire cycle, including days in which the patient will not be taking medication. Xeloda® (capecitabine), an oral chemotherapy regimen, is commonly dosed twice daily for 14 days, followed by a 7-day break. The proper days’ supply to bill is 21 days.

Some common examples seen in pharmacy, despite the lower cost and audit risk, include:

  • Birth control
  • Bisphosphonates, such as Fosamax® and Actonel®

Let’s take a commonly seen Synthroid® dosing regimen where a patient is to take medication five days a week:

#5 tablets per week x 4 weeks = #20 tablets for a 28 days’ supply

Note the days’ supply is computed in terms of number of weeks. Billing the claim for a 30 days’ supply would be incorrect. Humana would charge a $5 penalty fee for every audited prescription (and all associated refills) billed with that invalid days’ supply.

In addition to the claim with an incorrect days’ supply, there is a potential recoupment risk with subsequent fills. Billing a days’ supply shorter than the true days’ supply could cause future refills to be filled early, resulting in claims being fully recouped. Conversely, a claim billed for a days’ supply longer than the true days’ supply could lead to an erroneous “refill too soon” rejections, resulting in an interruption to a patient’s medication therapy.

If there is ever a question about whether a days’ supply is properly calculated, PAAS Audit Assistance members can call (608) -873-1342, email info@paasnational.com or submit a question online through the PAAS Member Portal. We want to help pharmacies prevent audits, so we are always happy to work with pharmacy staff to calculate the correct days’ supply prior to it being called into question in an audit.

PAAS Tips:

  • Unless explicitly stated in the directions that the medication is to be used as “extended cycling”, “continuous use”, or the like, take into account break days

Audit Trap: OptumRx’s Provider Manual Requirements

PAAS National® is starting to see more recoupments from OptumRx for missing prescription information. These recoupments stem from the provider manual requirements for prescription documentation that includes:

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  • patient full name
  • patient address
  • patient date of birth
  • prescriber full name
  • prescriber address
  • prescriber telephone number
  • other required identifiers of the prescriber (NPI, DEA, etc.)

OptumRx is stating these items are required on all prescription documentation, regardless of the way it has been created, generated, or transmitted (e.g., telephone orders).

This section of the provider manual has rarely been enforced by OptumRx until very recently. When cited for missing elements, pharmacies are not provided a pathway to appeal, even though these items may not be required by state or federal regulations. Even pharmacies who have this information visible on backtags have struggled to get it accounted for. Independence Blue Cross has also been known to cite the OptumRx provider manual for missing prescription documentation.

OptumRx is not the only PBM that has this type of language in the provider manual. Both CVS/Caremark and Express Scripts have similar language, although PAAS has not seen these sections enforced. Since provider manuals are considered extensions of your contract with the PBM, they can enforcement the requirement, absent state law prohibitions and applicability.

PAAS Tips:

  • Get into the habit of creating good documentation for prescriptions, especially telephone orders and transfers that may be handwritten.
  • Familiarize staff with provider manual requirements for prescription documentation.
  • Check your state regulations for additional prescription documentation requirements.

PHE for COVID-19 Ending May 11, 2023: Pharmacy and Audit Ramifications

On January 30, 2023, President Biden’s administration announced that both the national emergency and public health emergency (PHE) for COVID-19 would be ending on May 11, 2023. This will have far-reaching implications for everyone in healthcare, including pharmacy.

Audits

While the PBMs took a break from auditing pharmacies in the early days of the pandemic, most gradually started up again by the end of 2020. They started with desk audits and slowly added back in larger virtual audits to take the place of the onsite audits. Most recently, PBMs have reinstated onsite audits. If you feel like you have been seeing more audits, it is likely because you are.

  • January 2023, PAAS helped with 969 audits. A 30% increase year over year!

PBMs also made concessions in other audit areas due to the COVID-19 pandemic, including relaxed restrictions on mailing and delivery to patients during the PHE. They also made concessions allowing pharmacies to dispense prescriptions without obtaining a signature from the patient. While some PBMs and payors have already reinstated signature requirements, PAAS National® expects both of these situations to return to pre-pandemic requirements no later than May 11, 2023.

PREP Act

Some Public Health and Emergency Preparedness (PREP) Act authorities will end May 11, 2023, unless made permanent through state legislation. Check with your Board of Pharmacy and/or state pharmacy association to see what will still be allowed in your state. Requirements relevant to pharmacies that will be ending include coverage with no cost share for at-home COVID-19 tests/testing related-services for patients with Medicare, Medicare Advantage, and commercial insurance. Commercial insurers will also no longer be required to cover eight OTC tests per month. Health plans will no longer be required to reimburse out-of-network providers for tests/testing-related services, or cover vaccines for COVID-19 without cost-sharing when provided by out-of-network providers. They will also no longer be required to reimburse these vaccines at a “reasonable” rate.

It is difficult to know how the different health plans will handle these changes. Patients have grown accustomed to not paying any cost-share amount for these items. Adding cost-share may add to vaccine hesitancy concerns or hinder a patient’s ability to continue receiving COVID-19 vaccines and tests. Pharmacies will be on the front lines again helping patients navigate changing coverages.

PAAS Tips:

  • We recommend pharmacies start collecting signatures from patients for prescription pick-ups on or before May 11, 2023, if you have not already.
  • PAAS Audit Assistance members can review the February 2023 Newsline article, Are Your Delivery/Signature Logs PBM Compliant for 2023?
  • Check your state’s legislation to see what PREP Act authorities have been made permanent in your state.

Levemir® FlexPen® is Replacing the Levemir® FlexTouch®

Novo Nordisk® discontinued manufacturing the Levemir® FlexTouch® in early February 2023. The FlexTouch® will be distributed until stock is depleted and is being replaced with the FlexPen®. Please see the charts below for changes between the FlexTouch® and the FlexPen®.

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Levemir® FlexTouch® New! Levemir® FlexPen®
Changes
NDC 00169-6438-10 00169-6432-10
Pen Needle NovoFine® or NovoTwist® NovoFine® or NovoFine® Plus
Max # of units per single injection Up to 80 units Up to 60 units
Remains the Same
Type of Insulin Insulin detemir Insulin detemir
Manufactured 3 mL single patient use prefilled pen 3 mL single patient use prefilled pen
Unbreakable package size 5 x 3 mL pens 5 x 3 mL pens
How units are dialed Dialed in 1-unit increments Dialed in 1-unit increments
AWP $554.65 $554.65
# of units needed to prime each pen prior to use 2 units 2 units

PAAS Tips:

  • Due to the different features and functions on how to use
    • Review the new instructions for the Levemir FlexPen®
    • Get an updated prescription to minimize disruption to patient care

To Sign, or Not to Sign, the OptumRx® Recoupment Waiver … That Is the Question

If your pharmacy has recently been through an OptumRx® desk audit, you may have come across the OptumRx Provider Intent Form – Recoupment Waiver. This one-page form accompanies initial audit results and if signed, gives OptumRx® even greater power over the pharmacy. A signature on the form indicates the following:

There is no apparent benefit to the pharmacy by signing this form. Additionally, signing and agreeing to the preliminary audit findings could be construed as the pharmacy’s admission of wrongdoing. Only OptumRx® would benefit from this waiver and PAAS National® does not feel it is in the best interest of pharmacies to sign.

If you have additional questions or concerns regarding audit preparation, the audit appeal process, or safe billing and filling strategies, the PAAS team is here to guide you. Give us a call (608) 873-1342, email info@paasnational.com or submit a question online through the PAAS Member Portal.

First Step in Getting Help with an Audit

Oh no! You just received an audit, now what? Your first step is to get the audit notice to PAAS National® – the sooner that we are part of your team, the more benefit we can bring. Our all-inclusive membership means there are no hidden fees or limits to the audit assistance you can receive.

Make PAAS part of your audit process, every time. Review the 4 Steps to Using your PAAS Audit Assistance on the PAAS Member Portal for audit assistance members under Proactive Tips.

One of the best ways to get started is to create a workflow process when audits are received. Too many dollars are lost to PBMs due to missed deadlines or incomplete documentation – don’t let this happen to you. By putting a few simple steps in place, you can avoid costly mistakes in the future.

PAAS Tips:

Are Your Delivery/Signature Logs PBM Compliant for 2023?

A common component of a pharmacy audit request is the delivery/signature log. Delivery/signature logs are used to prove the patient received their medication and that they received it within the PBM return to stock timeframe. PAAS Audit Assistance members can refer to the PBM Return to Stock Chart on the PAAS National® Member Portal for a list of the major PBMs and their return to stock time frame allowances.

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PAAS often sees delivery/signature logs flagged for having a pre-printed delivery date. Several PBMs do not accept these logs because they may not represent the actual delivery date. Here is an example:

Recent Elixir results state, per the Elixir pharmacy manual, “Receipt submitted states “Delivery.” Unless the prescription delivery is through a common courier, an electronic or manual signature should be recorded at time of delivery by the member or designated member representative. For deliveries, the date delivered cannot be pre-printed by the pharmacy.”

Some software systems allow a pharmacy to “scan out” a prescription and flag it for delivery. The driver can take this date/time stamped point of sale receipt (that notates delivery) to the patient’s address and have them sign. PAAS also sees many LTC facility delivery manifests containing a pre-printed date on the document. An auditor is not going to accept/assume the delivery took place the same day as the pre-printed date and will likely flag these logs as invalid. The pharmacy needs to provide documentation of when the delivery took place by having the patient, or representative, date their signature upon delivery. Consider adding a blank line for a handwritten date next to the signature line that can be completed upon delivery.

PAAS Tips:

  • PBM Return to Stock requirements apply to retail and LTC pharmacies
  • A complete delivery/signature log should contain:
    • Patient name
    • Prescription number
    • Date filled or fill number
    • Date delivered – cannot be pre-printed
    • Delivery address – pharmacy, patient, or facility
    • Signature of patient, or the signature of representative who accepted the delivery, or indication of COVID-19 if appropriate
  • If Mailing:
    • 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 our COVID-19 PBM/Payers Concessions Chart 
    • The current COVID-19 PHE will expire 5/11/2023. See our article in next month’s Newsline for further considerations/implications.
    • If you are mailing out of state, be sure to check that state’s Board of Pharmacy to see if there are licensing requirements
    • PBMs that allow mailing will require proof that the patient received the medication and what was in the package
      • A tracking number linked to the prescription record along with tracking detail from the carrier showing the medication was delivered is traditionally sufficient
    • Be familiar with automatic mailing requirements for Part D patients, review the September 2022 Newsline article,  Automatic Mailing for Part D Patients
    • Read the November 2022 Newsline article, Yes, LTC Delivery Manifests ARE Needed!
    • The PAAS Trifold Signature Log Mailer is available for use on the PAAS Member Portal
  • If Medicare B DMEPOS Proof of delivery:
    • For in store pick-ups, the delivery date (date received) must match the date of service
    • For items delivered via a shipping service or mail, the date of service can be either the shipping date or delivery date
    • Read the June 2021 Newsline article, DMEPOS Proof of Delivery and Refill Request Requirements
  • Pharmacies using manual signature logs may want to consider ordering the PAAS National® Signature Logbook
  • Consult with your software vendor on updating your delivery/signature logs to include a signature date