GoodRx Shares Consumer Data

GoodRx, the website and app that has a seemingly endless TV marketing budget, has been sharing their consumer data with Facebook, Google, and others according to a recent article by Consumer Reports. During testing, Consumer Reports found that, “a company could infer highly intimate details about GoodRx users suffering from serious chronic conditions and make educated guesses about their sexual orientation.”

One company that GoodRx has shared consumer information with is Braze, a marketing firm, which claims that the data they collect is only used to target GoodRx users with information and not shared broadly with other advertising companies. GoodRx states Braze is used to send email or text reminders when a consumer is running low on their medication. Another company, Branch, claims it uses GoodRx data to make sure links work correctly in the mobile app.

According to Consumer Reports, both Facebook and Google have denied that they use prescription information to target consumers with ads, especially based on sensitive information like a person’s personal health information. However, Consumer Report’s Digital Lab observed sensitive information being passed to these companies and believes the app and website could be redesigned to prevent it from happening.

The big questions are: Is this legal? Doesn’t HIPAA apply?

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The short answers are yes, it is legal, and HIPAA does not apply to “direct-to-consumer” websites and apps. According to a February 2016 Office for Civil Rights (OCR) guidance on health apps, HIPAA “only covers health plans, health care clearinghouses, and most health care providers. If you work for one of these entities, and as part of your job you are creating an app that involves the use or disclosure of identifiable health information, the entity (and you, as a member of its workforce) must protect that information in compliance with the HIPAA Rules.”

Because GoodRx is a private company with no doctors or hospitals involved, it does not have to protect the health data a consumer gives it. Many consumers would be surprised to hear about this, although it is good to remember that if a service is free, the real product is the consumer and his or her data, and how a company shares consumer data is usually located in the fine print.

Shortly after the Consumer Report’s article came out, GoodRx posted a statement apologizing for the Facebook advertising in particular and vowing to “do better.” They also stated they would appoint a new VP of Data Privacy, make it possible for consumers to opt-out from cookies and tracking, and allow consumers to delete their data.

Auditors Targeting Ladder Schedule II Prescriptions

PAAS has been seeing an increase in audits for ‘laddered’ controlled substance prescriptions. A ladder prescription is a Schedule II controlled substance written as multiple prescriptions issued on the same date. This allows for fewer prescriber office visits where refills are not allowed by DEA regulations. They are commonly written for routine ADHD and pain medications.

The DEA has specific regulations for the issuance of multiple prescriptions for Schedule 2 controlled substances in 21 CFR §1306.12. The requirements include:

  • Each prescription must be for a legitimate medical purpose
  • Prescriptions may be for a total of up to a 90-day supply
  • Prescriptions must have written instructions indicating the earliest date each prescription may be filled
    • Except the first prescription if intended to be filled immediately
  • Prescriber determines that issuing multiple prescriptions does not increase risk of diversion or abuse
  • Prescriptions must comply with any additional state laws or regulations

PAAS Tips:

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  • Make sure that multiple prescriptions do not exceed a 90-day supply
    • Most common is 3 x 30-day supply prescriptions
    • 6 x 15-day supply may be allowed
    • Cannot do 4 x 30-day supply or 3 x 31-day supply
  • Ensure that all prescriptions have the same issue or written date
    • This must be the date that the prescriber signed or issued the prescriptions
  • Written date must be accurately entered into the prescription claim
    • Do not use the ‘Fill on’ date as the written date
    • Entering the wrong date can lead to Wrong Hard Copy or Invalid Written Date discrepancies. It may also result in a claim being filled past the normal expiration date
  • Ensure that at least the 2nd and 3rd prescriptions have the ‘Fill on’ or dispense date clearly indicated
    • Must be an actual date
    • ‘Fill 30 days after xx/xx/xx’ is NOT accepted
  • Ensure that all DEA required elements are present on the front face of the prescription
    • Patient name and address
    • Prescriber name, address, and DEA
  • Follow all state requirements for dispensing Schedule 2 controlled substances:
    • Prescription expiration after written
      • Varies from 7-90 days after written date
    • Supervising physician information for mid-level practitioners
      • May require supervisor’s name, address, phone, NPI, and/or DEA
    • What can be changed or clarified on a Schedule 2 prescription
      • DEA no longer allows changes to a Schedule 2 prescription unless specifically allowed by state regulations
      • Verify with your State Board of Pharmacy

Stop Breaking Insulin Pen Boxes

PAAS National® sent out an URGENT Email Alert February 18, 2020 regarding the FDA’s involvement in the breaking of insulin pen boxes. The pharmacy industry has long debated whether one box of insulin pens is considered “unbreakable”. The debate appeared to be settled January 22nd, 2019 when the U.S. Department of Justice issued a press release stating Walgreens agreed to a $209 million fraud settlement with the federal government regarding its billing and dispensing of insulin pens to Medicaid, Medicare Part D and TRICARE patients. Prior to the settlement, Walgreens’ policy was to not dispense any insulin pens in quantities less than one full box, forcing their staff to falsely understate the days’ supply on thousands of claims. They then enrolled many of these patients on its refill reminder program, causing patients to get early refills. The government labeled that billing activity as widespread FRAUD and required Walgreens to enter into a Corporate Integrity Agreement with the Office of the Inspector General. Consequently, both Walgreens and CVS have been breaking insulin pen boxes when appropriate.

Since that time, PAAS has seen OptumRx, Express Scripts, Humana, Prime Therapeutics, and EnvisionRx dramatically increase their audit recoupments on insulin pens being dispensed that exceed plan limits.

To complicate the matter, the FDA got involved June 20th, 2019 when it sent a “Safety-Related Supplement Request” to Eli Lilly, Sanofi, and Novo Nordisk requesting:
      “…updates to the Prescribing Information (PI) and carton labeling to specify that pens be dispensed in the original sealed carton…”

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Consequently, the manufacturers submitted supplemental new drug applications (sNDAs) to update the information accordingly and on November 15, 2019 the FDA published updated labeling. PAAS National® has been in correspondence with the FDA and manufacturers to better understand the June 20th request (and ensuing conversations on October 10th between the FDA and manufacturers). We are presently awaiting a Freedom Of Information Act (FOIA) request through the FDA to gain further clarity. Conjecture leads us to believe it’s related to a lack of Patient Instructions for Use being provided in the carton, or a possible increase in reported medication dispensing errors.

Regardless, it is important to note that PBMs are aware and will likely enforce the revised standard during audits (i.e. do not break insulin pen boxes). PAAS just received audit results where the PBM expected insulin pen boxes to have been broken between 1/22/2019-11/15/2019, and post-11/15/2019 they are expecting full insulin pen boxes to be dispensed. The absurdity is not lost on PAAS, but PBMs will use anything they can to deny paying claims – especially high dollar insulin claims.

Updated Section 16.2 of the package insert, and the exterior carton, will now state to dispense in the original sealed carton. Your supply chain and inventory management will dictate when you start seeing the revised product labeling, if you haven’t already.

16.2 Storage

Dispense in the original sealed carton with the enclosed Instructions for Use.

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PAAS has been able to confirm ALL insulin pen products on our Insulin Medication Chart have updated product labeling on the Carton and in Section 16.2 (with the exception of Insulin Lispro (AG) and Novolog Cartridges). This includes combination products, Soliqua® and Xultophy®. We have not seen any revisions with GLP-1 Receptor Agonist products (e.g. Victoza, Trulicity, etc).

PAAS Tips:

  • Pharmacies should always try to first bill an accurate days’ supply based on the prescribed quantity– many insurers have accommodated days’ supply limits well in excess of 90 days
  • If plan limits are exceeded follow the guidance below:
    • Multiple cartons – reduce the # of cartons and corresponding days’ supply until the claim will adjudicate. Document Insurance Limits Quantity (e.g. ILQ = 30 days) on the hard copy.
    • Single carton (in order of preference):
      • Call the help desk and request an override
      • If no override is available, adjust the days’ supply to the Plan Limit
      • Best practice: note the actual days’ supply in the patient sig – and make patients/staff aware of the process
      • Do NOT refill the product early. When overriding the accurate days’ supply to meet plan limits, pharmacies can no longer rely on adjudication to properly reject claims that are refill too soon. All PBMs (including Caremark) will recoup for early refills on an audit. Since the original claim was rejected with an accurate days’ supply, PBMs know the actual day’s supply and will be looking for pharmacies that refill it earlier than allowed.
  • Open boxes in inventory – PAAS recommends using up any open boxes as soon as possible prior to transitioning. Be sure to include a Patient Instructions for Use.


PAAS Audit Assistance members can visit our Tools & Aids to find updated versions of our popular tip sheets:

  1. Can You Bill It As 30 Days?
  2. Insulin Medication and Injectable Diabetic Medication Charts
  3. Diabetic Injectables FAQs

Auditors Scrutinize Printed Electronic Prescriptions!

PAAS has observed audit results from Humana where electronic prescriptions are marked as invalid (INVP) due to missing electronic elements. Humana results have stated “Hard copy provided does not contain an electronic physician’s signature, SPI number, Transaction Number, or Message ID.”  Software systems often have multiple ways to print an electronic prescription. When a pharmacy prints an electronic prescription for audit purposes, be aware of the electronic prescription requirements and ensure they are present.

PAAS Tips:

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  • Be proactive and self-audit your electronic prescriptions to make sure required elements are present on the printed copy
    • SPI = Prescriber’s Surescripts Provider ID number
    • Message ID or Transaction ID number = assigned to each e-prescription by the prescriber’s application when it is written
    • Date and Time Stamp
    • Electronic Signature
  • Contact your software vendor if any of the above elements do not show up on a copy of your electronic prescription
  • Make sure your electronic prescription copies are valid for audit purposes to help avoid recoupments

OptumRx/SCIO Targeting Part B Drugs & Supplies

In the most recent round of OptumRx/SCIO desk audits, PAAS is seeing audits for test strips, insulin used in a pump, nebulizer solutions, immunosuppressants, chemotherapy medications, and vaccines. If the patient is Medicare-eligible and meets Medicare requirements, these claims should be billed to Medicare Part B. If the pharmacy is processing under a Medicare Advantage plan (Part C), they are required to cover everything that is covered by Part A, B and sometimes D. Some plans require that all drugs and supplies be billed to the prescription benefit and they will process them under either B or D as appropriate. Other plans may require that you bill Part B drugs and supplies to the medical benefit and only Part D to the prescription benefit.

Why do these potential Medicare B claims go through the Part D plan at the point of sale? 

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Medicare has directed the plan sponsors to cover all claims at point of sale to prevent any delay in patient care. Section 20.2 in Chapter 6 of the Medicare Prescription Drug Benefit Manual states “Part D sponsors generally may use either PA requirements or a ‘pay and chase’ approach to determine whether payment for drugs may be made under Part D.” All health care providers should be knowledgeable about Medicare coverage prior to providing services or items to Medicare beneficiaries. CMS expects that pharmacies know Medicare coverage requirements so they can anticipate payment denial. Section 20.2.2 in Chapter 6 discusses the expectations of Part D sponsors to perform due diligence in Medicare A/B vs D coverage.

PAAS Tips:

  • Pharmacies should be aware of drug classes typically billed to Medicare B
  • Determine if patient is Medicare eligible
  • Contact the equipment supplier to verify if they are billing Part B for supplies, if so, then the drugs should be billed to Part B
  • If billing a Part C plan, confirm with the plan on how to bill
  • Pay close attention to any soft reject messages and do not override just to get a claim paid

Caremark Strictly Enforces Coupon Policy

Caremark Strictly Enforces Coupon Policy

CVS Caremark first updated their policy on the use of manufacturer coupons in May of 2017 and again in September of 2018. Pharmacies continue to suffer full recoupment of claims that were processed to coupons and copay cards in violation of Caremark’s policy. Caremark considers violations to be inappropriate waivers of patient pay amounts, and could result in additional sanctions, including termination.

As defined in the current Provider Manual: “Pharmaceutical Manufacturer Coupon” means any item or mechanism, including but not limited to, paper coupons, copay cards, e-vouchers, mail-in rebates, and electronic coupon codes funded by a manufacturer, repackager, or supplier of pharmaceutical, chemical, or compounding products, that reduces the portion of the Patient Pay Amount that an Eligible Person is required to pay for a Covered Item.

Caremark prohibits the use of any coupon for:

  1. Compounds;
  2. Federal health benefit programs, including Medicare, Medicaid, and TRICARE;
  3. Dietary supplements, devices, and any drug NOT approved by the FDA under a New Drug Application (NDA), Abbreviated NDA (ANDA), Biologic License Application (BLA), OTC Monograph, or otherwise Generally Recognized as Safe and Effective (GRASE);
  4. Certain programs identified by Caremark as being suspect include: Affordable Medication Solutions, RetainRx and Phoenix PBM.

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PAAS Tips:

  • Avoid using any type of coupon, rebate, or discount for unapproved drugs, dietary supplements, or medical devices
    • Vitamins and dietary supplements
    • Topical creams, emollients, lotions, and ointments that do not contain approved drug products
    • Saliva substitutes
  • Caremark’s definition includes programs that are provided by wholesalers and repackagers, not just manufacturers
  • Never use a program that is directly or indirectly funded by the pharmacy. These programs are schemes used to mask illegal waiver of copays and are considered fraudulent
  • Be cautious with any claim that has a copay greater than $100. High copays are intended to discourage patients from using non-formulary or non-preferred products and plans may require proof of copay collection and/or secondary processing information.
  • Be cautious with products that are not stocked by primary wholesalers; they are often unapproved products
  • Having an NDC does not indicate FDA approval. Check your pharmacy or wholesaler database for the FDA Marketing Category, NDA, ANDA, or BLA number. See NDC Number Does NOT Mean “FDA Approved” from September 2018 issue for more details.

Note: First DataBank (FDB) recently updated their database to list dietary supplements differently than approved drug products.

With USP <795> and <797> on Hiatus, Time to Focus on USP <800>

On September 23rd, USP announced they were postponing the official dates of the revised General Chapters <795> and <797> (and <825> – radiopharmaceuticals). Stakeholders submitted appeals and have now requested further review by an appointed panel. In question are Beyond Use Dating requirements and Alternate Technology Provisions. According to the USP Bylaws, the panel will meet within 90 days. If the standard is upheld, the date for conformance will be reestablished with at least a six-month notice.

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USP <800> is not subject to any pending appeals and will become official December 1st, 2019. Many facets of USP <800> are intertwined with compounding (<795>/<797>), so the General Chapter will be considered informational and not compendially applicable at this time.

With rare exception, all pharmacies will be responsible for meeting USP standards in General Chapter <800> Hazardous Drugs – Handling in the Healthcare Settings. If your pharmacy plans to prepare compounded prescriptions with Hazardous Drugs (HDs), then you must comply with all elements of the standard, including the extensive containment requirements. If your pharmacy does not plan to compound with HDs but has HDs in inventory (as all traditional pharmacies do), then your responsibilities are greatly reduced, but there are still aspects of USP <800> you must comply with.

USP developed General Chapter <800> to address a public health need to protect healthcare personnel from HDs. Both acute and chronic health issues can arise from improper handling or exposure to HDs. HD handling is not new. The National Institute of Occupational Safety and Health (NIOSH) first published a list of HDs in 2004 and the Occupational Safety and Health Administration (OSHA) first published guidelines for HD handling in 1986 (originally only cytotoxic [antineoplastic] drugs).

Various states have adopted USP <800> into law as they feel it’s the best practice to prevent employee, and public, harm. However, regardless of whether a state has specifically enacted USP <800>, all pharmacies should have robust policies and procedures to handle HDs. OSHA was established to ensure safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education and assistance.

The following statement was taken from OSHA’s website regarding HDs:

“Institutions should have formal written programs to manage hazards. Such programs should include training, exposure assessment, emergency procedures for spills, policies for managing staff with reproductive concerns, and most importantly, ways to ensure that the institution is adhering to critical national standards.

Although OSHA has no explicit standard, USP 800 focuses explicitly on protecting workers from exposures to hazardous drugs. It, and USP 797, represent professionally expected requirements in healthcare that incorporate national consensus standards on infrastructure maintenance (ASTM).”

OSHA also makes available guidance on Controlling Occupational Exposure to Hazardous Drugs. They have the authority, and resources, to enforce USP <800> for the welfare and safety of pharmacy employees.

PAAS Tips:

  • Where to start (not all inclusive):
    • Review Applicable USP Chapters
    • Download NIOSH HD list
    • Establish a qualified/trained individual to be responsible for developing and implementing appropriate standard operating procedures
    • Complete an Assessment of Risk for all HDs that are dispensed in the pharmacy. NCPA has made a template available for consideration.
    • Obtain Safety Data Sheets for all Hazardous Chemicals
  • If you have HDs from the NIOSH list in your inventory that in are in final dosage forms and do not require further manipulation (other than counting or repackaging – unless specified by manufacturer) you may not need to follow all the containment requirements of USP <800>, but should consider the following
    • Tablets and capsules may not pose a significant risk of direct occupational exposure; however, dust from tablets/capsules may present a risk of exposure by skin contact or inhalation
    • If you do not perform an assessment of risk, all HDs must be handled with containment strategies defined in USP <800>
    • Counting or repackaging of HDs must be done carefully. Clean equipment (e.g. counting trays and spatulas) should be dedicated for use with HDs and should be decontaminated after every use.
    • Tablet and capsule forms of antineoplastic HDs must not be placed in automated counting or packaging machines, which subject them to stress and may create powdered contaminants.
    • Splitting HD tablets (e.g. Warfarin 1 mg) is considered manipulation and should only be done if a pharmacy is in full compliance with USP <800>
  • If you plan to compound under USP <795> or <797> using HDs, you must fully comply with USP <800>.

Disputing Humana’s Bogus $5 Administrative Fees

By now, most pharmacies are probably aware of Humana’s $5 administrative fees to correct, what other plans consider, educational discrepancies. We commonly see these fees assessed for incorrect prescriber (for legend drugs), invalid days’ supply, and incorrect origin code. State audit laws have been ineffective at protecting pharmacies from these clerical errors as Humana classifies these takebacks as “Administrative Fees”, not recoupments on the initial claim.

What should your pharmacy do when assessed a $5 fee?

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First, check the claims to make sure Humana is valid in their assertion. PAAS has recently seen numerous audit results where the auditor made a mistake on days’ supply, which was subsequently overturned. Auditors are not immune to mistakes with origin codes or prescribers, either.

Reviewing these fees are easy to do and should not be overlooked on appeal. These fees apply to the original fill and all refills, so a prescription with 12 fills can have $60 in fees. These fees are in addition to any discrepancy Humana may be assessing on a claim; which could lead to > 100% recoupment! PAAS recommends you dispute all recoupments, big or small.

PAAS Tips: 

  • Invalid Days’ Supply: Check the math to make sure the auditor did not make a mistake.
  • Wrong Origin Code: Double check the origin code that you billed. Does Humana’s assessment make sense?
  • Incorrect Doctor: Check the NPI billed. Is your system set up to correctly link the doctor’s name with their NPI?
  • If you find a mistake, use the Humana Corrected Values Form (CVF) to appeal the fee. This CVF should have been included with the result materials.

Remember to send your results to PAAS to have the best chance during appeal!

Split Billing Opioid Prescriptions

PAAS has received numerous questions related to split-billing opioid prescriptions to insurance and cash. The current state of the opioid crisis has made these claims targets for audit recovery and DEA scrutiny.

PAAS recommends …

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against split billing or processing a claim as cash to circumvent a plan limit or prior authorization requirement. Most limits are based on appropriate clinical use. Bypassing these edits for opioids can lead to overdoses, diversion, and even death. Especially for controlled substances, pharmacists have a corresponding responsibility to ensure that prescriptions are for a legitimate medical purpose 21 CFR 1306.04(a).

PAAS Tips:

  • PBMs will monitor and flag claims that are rejected for plan limits and reprocessed with changed quantity and/or days’ supply
    • Claims will be recovered in full if billed with the wrong days’ supply and exceed plan limits
    • For example, Oxycontin 30 mg #90 1 po TID, plan limit 2/day: billing #60 as 30 days’ supply is incorrect for TID dosing and will likely be recovered in full
  • PBMs may have access to state prescription drug monitoring programs (PDMPs) to look for cash claims
    • Charging the patient cash can be considered non-compliance with the provider manual and could lead to remediation, including potential network termination
    • If you have exhausted all plan options and the patient insists on paying cash for the full prescription, be sure that you document authorization from the patient that they are willing to pay the full cost and will not seek reimbursement from the insurance. This may protect you from accusations of non-compliance.
  • Multiple transactions on the PDMP may raise red-flags for state and DEA agents as a possible diversion
  • Always call for an override or prior authorization. Most edits can be overridden with appropriate clinical documentation
  • Obtaining prior authorization can often resolve the problem for six months to a year
  • Prescribers that are unwilling to obtain prior authorization or to change the prescription to a clinically appropriate dose may be a red-flag for diversion
  • Don’t be afraid to enlist the patient’s help. Having them file a complaint with their insurance can help expediate the PA approval process. 

Prime Recovering Claims on Drug Substitutions

PAAS has seen Prime Therapeutics recover claims for the following reasons:

  1. FCD: “The pharmacy has submitted this claim or series of claims multiple times using a different drug throughout the claim submission.”
  2. FCR: “The pharmacy has submitted this claim or series of claims incorrectly. If submitted correctly, this claim, or series of claims would have rejected and required a prior authorization review.”
  3. FCP: Prior Authorization – “The pharmacy has submitted this claim or series of claims inappropriately in order to obtain an approved prior authorization.”

Inappropriate Billing Practices are discussed in the Prime Provider Manual, Section 2 and Unacceptable Billing Practices are found in Section 6. Here are a few examples:

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  • Inappropriate application of therapeutic interchange protocols – A participating pharmacy dispensing a different covered medication than prescribed without obtaining and documenting the Prescriber’s consent prior to dispensing and without informing the Covered Person of the substitution
  • Phishing to identify a drug that is covered (i.e., a Participating Pharmacy submits a claim for one drug, receives a reject or reverses the claim and then resubmits for a new drug within a short period of time)
  • Billing high cost products when lower cost alternative products are available
  • Billing for drugs that the Prescriber did not order
  • Billing for drugs where the Covered person and the Prescriber do not have a valid patient-prescriber relationship
  • Billing for drugs where the Pharmacy does not have a valid prescription order
  • Billing for a therapeutic interchange medication without contacting the Prescriber before the claim is submitted to confirm the interchange
  • Billing for prescriptions during posted business hours when the Pharmacy is not physically open
  • Billing for prescriptions in order to bypass the POS edits or messaging

PAAS Tips:

  • Do not bill test claims – always bill pursuant to an actual prescription. Should a patient request their prescription back, make sure to retain a copy for your records.
  • Do not bill a claim for a drug that has not been authorized by the physician
  • Always follow POS reject messages – do not bypass plan limits or prior authorization requests, including changing quantity, days’ supply, or price
  • If the prescriber is authorizing a change in the medication, it is ideal (for their corresponding records and yours) to have the prescriber send a new prescription to the pharmacy
  • Review the Prime Provider Manual for best billing practices and the discrepancy code table
  • PAAS National® recommends against the use of template or pre-printed prescription forms with broad substitution protocols or cascades. See May 2019 Newsline article Pre-Printed Prescription Forms Put You at Risk.