Audit Issue: Patient or Prescriber Denials of Prescriptions

PAAS National® analysts have seen numerous PBM audit results where pharmacies had recoupments related to patient or prescriber denials of medications. Pharmacies are able to appeal by obtaining signed statements to overturn the denials.

In certain instances, such as investigations, PBMs are reaching out to both patients and prescribers to validate pharmacy claims. Presumably, PBM auditors/investigators are independently collecting evidence to ensure that “the stories match” to determine if pharmacies are acting in good faith. Unfortunately, they typically presume guilt until proven innocent.

Patients may be sent official letters from PBMs asking various questions detailing the interaction with your pharmacy. Here are some common questions that letters may include:

  1. Did you receive the following prescriptions?
  2. Did you authorize the pharmacy to refill the following prescriptions?
  3. Did you pay the copay?
  4. Did the pharmacy offer you a discount on your copay?
  5. How did you receive the following prescriptions (in-person, delivery, mail)?

Some patients may not remember the details of a prescription from years ago, or be scared to answer incorrectly, and decide to not respond. If a patient fails to respond to such a request, this non-response may be deemed a denial, and thus the pharmacy is presumed guilty.

Additionally, PBMs are reaching out to prescribers to determine if prescriptions were authorized to confirm legitimacy. Like patient denials, a non-response from a prescriber’s office paints the pharmacy as guilty (even if you have a date/time stamped electronic prescription – absurd!). Other issues that may come up include prescriber moving practices, retiring or if the pharmacy accidentally billed the claim under the wrong prescriber’s NPI.

If you receive audit results that include recoupments for patient or prescriber denials, consider the tips listed below to help you in your response.

PAAS Tips:

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  • Send audit results to PAAS for assistance in developing an appeal strategy
    • The foundation of an appeal will include signed statements from patients or prescribers to overturn the findings
    • Each PBM has unique requirements for such statements, make sure you understand the fine print
  • It is important to consider documentation already in your possession that can help support your case such as prescriptions or signature logs
  • It is helpful to understand if denials are passive (respondent did not respond) or active (respondent actively denied)

Insulin for a Pump – Medicare B or Medicare D?

PAAS National® analysts are frequently asked how insulin for a pump should be billed for Medicare eligible patients. Incorrect billing has caused very high dollar recoupments for some pharmacies. Be sure you know how to correctly bill your patients’ insulin.

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Insulin pumps currently fall under two categories, durable (tubed) or disposable (tubeless). Medicare coverage for insulin used in a pump will be determined by what type of pump the patient is using. Two examples of disposable or tubeless insulin pumps are the Omnipod® and the V-Go®. Because patients are required to discard and replace the insulin reservoirs, this categorizes them as disposable. Medicare Part D would cover insulin used in these types of insulin pumps.

Pharmacies must be mindful when dispensing insulin vials for Medicare eligible patients. Medicare Part D plans will not reject insulin claims, so you must monitor these closely. Not every prescription will state if it is used in a pump. Patients not receiving insulin syringes to use with insulin vials could indicate a pump is being used. PAAS recommends asking patients for confirmation of injecting or using in a pump prior to dispensing. See Billing the Correct Insulin for Use in a Pump in this month’s Newsline for types of insulin covered/not covered when used in a pump.

PAAS Tips:

  • When receiving a prescription for insulin vials PAAS recommends the following:
    • Identify if patient is Medicare eligible
    • Check if patient is injecting insulin, or if it is being used in a pump
    • Identify what type of insulin pump the patient is using, durable or disposable
      • If durable, was pump covered by Part B?
    • Self-audit prescriptions for insulin vials to ensure billing was done correctly
    • Contact PAAS National®® for additional questions regarding insulin for a pump

Caremark Complex Compounds

PAAS National® analysts have recently worked with multiple pharmacies that received Compound Contract Violation notices from Caremark stating that the pharmacy must cease and desist submitting claims for “complex compounds” and reverse claims provided on an attached list. Letters state that failure to comply could result in network termination. In one instance, the notice was labeled “Second notice” and referred to a previously issued “First notice” reportedly issued in 2020, however the pharmacy had no record of the prior notice.

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In each case, pharmacies reported that the claims were all non-sterile compounds, many of which were oral suspensions made with crushed tablets or topical creams made with bulk powders. Additionally, pharmacies stated that claims were paid at point-of-sale with no reject messages or need for overrides or prior authorizations.

Caremark’s definition of “complex compounds” is not included in the notices sent to pharmacies, nor does it appear in the Pharmacy Provider Manual. Additionally, it is not related to the Level of Effort value submitted. PAAS first saw the definition provided in an Addendum to Caremark Provider Agreement Compounding: Limited Scope of Pharmacy Services in 2014 and was presented at the time as shown below:

‘A non-complex compound is compound that is not complex, and a “complex compound” is defined as a compound that meets any one of the following three (3) elements:

(1) a mixture of chemicals that involve bulk chemicals (API), aliquots, or dissolutions of tablets and/or capsules;

(2) the route of administration does not remain in accordance with FDA-approved labeling/indications for each ingredient contained within the compound; or

(3) requires specialized equipment (unguator, ointment mill, etc.), training, or gowning or requires special environmental conditions to protect pharmacy staff and public.’

PAAS Tips:

  • See Section 2.02 of the 2022 Caremark Provider Manual for more details on becoming a complex compound provider for Caremark
  • Contact Caremark at CompoundApplicationTeam@CVSHealth.com to request authorization to bill complex compounds
  • It is unclear how serious Caremark is about this issue based on the issuance of multiple notices over many years without consequences and no hard rejections at point-of-sale

Cash Copay Collection

Numerous PBMs are conducting audits and asking for proof of copay collection. This is relatively easy to respond to (albeit annoying) when patients have paid by check or credit card as there is a “paper trail” of the financial transaction. PAAS National® analysts have seen some pharmacies struggle to provide evidence of cash transactions as they do not have sophisticated point-of-sale systems that record the method of payment or they lack consistent cash handling policies and procedures, or both.

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Of particular concern recently has been Caremark, who requires that pharmacies provide bank deposit slips as evidence of cash copays (the final step in the “paper trail” evidence). While, clearly, individual bills received from a patient at the register cannot be linked to a particular transaction, Caremark may be suspicious of large copays paid in cash and will demand to see bank deposit slips that exceed (in the aggregate) the amount of the individual copay.

If your pharmacy cannot provide sufficient evidence of copay collection, then PBMs may recoup claims during audit and potentially terminate your pharmacy agreement.

Consider the PAAS tips below to strengthen your cash handling procedures where needed.

PAAS Tips:

  • Don’t wait for an audit, with Proof of Copay Collection requirements, to upgrade to an integrated Point-Of-Sale system. Benefits may include:
    • Creation of itemized sales receipts with date and time of sale, individual items sold, dollar amount of each item (e.g. copay) and method of payment received
    • Additional features often include:
      • Incorporate electronic signatures as proof of dispensing and acknowledgement of HIPAA notice of privacy practices
      • Link to OTC inventory levels for reporting and automatic reorder points
      • Link to pharmacy dispensing software to update a work queue, mark prescriptions as “sold” or even hard-stop prescriptions if trying to sell a certain number of days after fill date (may prevent dispensing beyond PBM return-to-stock window)
      • Query transactions such as when responding to a PBM audit or if a customer disputes payment amount or receipt of a medication at a later date
    • Develop or revise cash handling policies that include:
      • Making deposits to the bank at regular intervals (e.g., weekly)
      • Avoid taking money out of the register to run the business (e.g., buying stamps, staff lunch, etc.)
      • Balance the register at the end of every business day
        • Breakdown cash by denomination and document for comparison against the next deposit
        • Leave a set minimum amount for open of next business day
        • Additional funds should go into a safe until the next scheduled bank deposit
        • If you have a point-of-sale system, it should be able to reconcile every transaction of the day to ensure you have the right amounts on-hand and identify any lost payments or theft

Small Differences Between Prescription Directions and Patient Label Can Lead to BIG Recoupments

PAAS National® recommends attention to detail when it comes to typing directions for patient labels. Many PBMs require the patient label directions match the prescription directions exactly, or a pharmacy may face recoupment for a “misfilled” prescription.

Errors on the patient label can range from simple typos to dosing errors. Even seemingly innocuous additions to the patient label (e.g., a diagnosis code or time of administration) can lead to potential audit discrepancies when added without prescriber approval (or documentation). If the prescription directions are clarified with the prescriber’s office, make sure to add a clinical note and update the patient label. See our November 2020 article Are Your Pancreatic Enzyme Prescriptions Audit Ready? for a common issue between the prescription directions and patient label.

Another problematic patient label issue PAAS frequently sees is regarding units. Consider Victoza®, which typically has directions in mg, but has often been mistyped as mL. See our January 2021 article Victoza – One Letter Can Cost You! for more detail.

PAAS Tips:

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  • Label directions should be typed exactly as they appear on the prescription and mathematically calculable for days’ supply
    • PBMs look to recoup on a prescription/label mismatch when it could cause a clinical error or if it appears that a clinical annotation was added after the prescription was dispensed
    • Adding the route of administration is typically not an issue unless the route added is incorrect (see our September 2019 article Route of Administration is Important)
  • If clarifying directions with the prescriber, the updated directions need to be included on the patient label
  • Examples of instructions that should be clarified:
    • Sliding Scale Insulin without a max daily dose, pancreatic enzymes taken with meals and snacks, and instructions to be taken “As Needed” should have a maximum daily dose
    • “Use as Directed” – per package? Off-label? See PAAS Newsline article February 2022 Use Care with Unit of Use Packages and “Use as Directed” for more information
    • Topical products should ideally contain a mathematically calculable amount to be applied per application or maximum per day. See our Topical Creams and Ointments days’ supply chart for more details
  • Diagnoses should only be included if written by the prescriber
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Billing the Correct Insulin for Use in a Pump

Insulin is a very popular audited drug category due to its complexity, frequency of use, and high cost. When used in conjunction with an insulin pump, it adds another layer of complexity.

One of the reasons insulin claims for Medicare Part D patients are commonly audited is because the PBMs can’t identify if the patient is self-administering (and Part D is responsible) or using in a pump (where Part B may be responsible) at adjudication. PBMs may isolate insulin claims if a member does not have any syringes being billed to Part D along with their insulin. The pharmacy should always verify with the patient or prescriber if insulin is being used in a pump.

Billing the wrong type of insulin for a pump can also result in large audit recoupments. See the tips below for which insulin types should, and should not, be used in an insulin pump.

PAAS Tips:

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  • Do NOT bill the following long acting, pre-mixed and concentrated insulins for use in a pump
    • Insulin pens should never be used with pumps
    • Intermediate or long-acting insulins like NPH, glargine (Basaglar®, Lantus®, Levemir®, Rezvoglar™, Semglee®, Toujeo®), Levemir®, and Tresiba®, as well as pre-mixed insulins like 70/30, 50/50, etc. should never be used with pumps
    • U-500 is not FDA approved for use in a pump
  • Appropriate Insulins for use in a pump are rapid-acting
    • Aspart – NovoLog®, Fiasp®
    • Lispro – Admelog®, Humalog®, Lyumjev®,
    • Glulisine – Apidra®
  • See September 2020 Newsline Billing Insulin for a Pump is Tricky, especially for Medicare Patients
  • See April 2022 Newsline Insulin for a Pump – Medicare B or Medicare D?

Hackers Don’t Sleep, Your PHI is At Risk! What Are Your Safeguards?

Pharmacies, big and small, may find themselves on the probing end of a hacker’s criminal scheme designed to access and steal protected health information (PHI). Recently, CVS Pharmacy, Inc., Ravkoo (affecting Amazon Web Services), and Florida-based BioPlus Specialty Pharmacy Services LLC have all been targets of malicious actors after PHI. It comes as no surprise that the U.S. Department of Health and Human Service’s Office for Civil Rights (OCR) 2022 first quarter Cybersecurity Newsletter reported an increase in cyberattacks from 2020 to 2021. According to the OCR’s report, cyberattacks and “IT incidents” accounted for 66% of breaches affecting 500 individuals or more, and according to the 2020 Data Breach Investigations Report by Verizon, over 80% of data breaches due to hacking were from weak authentication requirements.

Having safeguards in place to detect, and prevent, unauthorized users from accessing PHI and electronic PHI (ePHI) is a requirement for all covered entities as outlined in the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and clarified by the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009. Although ePHI is usually the target of cyberattacks, it is important to be aware of the potential for internal breaches as well, some of which may be the result of inadequate policies and procedures, not necessarily malicious actors. Rite Aid pharmacy chain found out the hard way that tossing medication vials with patient information into their regular trash bins was not the correct way to dispose of PHI. Rite Aid’s $1 million settlement for having insufficient internal policies and procedures for handling PHI can serve as a reminder of the importance of evaluating your own HIPAA policies and procedures. In fact, periodically reviewing your security protocols and correcting your security shortcomings is a HIPAA Security Rule requirement.

PAAS National® has a customizable Fraud, Waste & Abuse (FWA) and HIPAA Compliance Program with tools and resources to help pharmacies meet HIPAA and HITECH compliance requirements. The PAAS FWA/HIPAA Compliance Program walks members through setting up a robust compliance program which includes:

  • appointing HIPAA Privacy and Security Officers,
  • performing a Risk Analysis to identify and document threats and vulnerabilities that may impact ePHI,
  • developing administrative, technical and physical safeguards to protect ePHI,
  • developing customized HIPAA Policies and Procedures (including proper PHI disposal, security reminders, access controls, prevention of malicious software, etc.),
  • online HIPAA training and much, much more!

Having a robust HIPAA Compliance Program and an educated workforce that is fully engaged in protecting PHI can greatly reduce the risk of unauthorized access to PHI and ePHI. Don’t be the weak link and have no plan in place – it’s the law!

PAAS Tips:

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  • Review your HIPAA policies and procedures to check for appropriate administrative, technical, and physical safeguards
    • Administrative safeguards should include risk analysis, risk management, sanction policy, and information system activity review
    • Technical safeguards include access control (i.e., user identification, emergency access procedure, automatic logoff, encryption, and decryption), audit controls, ePHI integrity, person/entity authentication, and transmission security
    • Physical safeguards include facility access controls (i.e., contingency operations, facility security plan, access control and validation procedures, maintenance records), workstation use and security, and device and media controls
  • PAAS National® is here to assist you with your FWA and HIPAA Compliance needs and questions, call (608) 873-1342 today to start customizing a program for your pharmacy!

LIVE WEBINAR APRIL 7th: Compliance Issues, HIPAA Enforcement and Audit Risks with COVID-19

Join President of PAAS National®, Trenton Thiede, PharmD, MBA for a LIVE webinar “Compliance Issues, HIPAA Enforcement and Audit Risks with COVID-19” on April 7, 2022 from 2-2:45pm CT as he discusses:

  • Compliance Program Requirements (and why it matters to community pharmacies)
  • Recent HIPAA Enforcement/Action
  • COVID-19 Vaccine Audit Risks (updated)
  • OTC COVID-19 Tests Audit Risks (and Medicare B guidance)
  • Onsite Audit Preparation

We will allow for some Q&A at the end of the webinar.

SIGN UP TODAY!

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

Beware and Be Ready! In-Person Onsite Audits Are Resuming

OptumRx and Express Scripts recently sent notices to pharmacies informing them in-person onsite audits will be starting back up in April. PAAS National® has also reviewed audit notices from Caremark and MedImpact with intentions of visiting the pharmacy in person to conduct the audit. We would expect other PBMs to follow this trend as well.

COVID-19 restrictions lead PBMs to conduct their audits virtually since early 2020. Pharmacies would respond to the audit request by submitting documents in for review and having a compliance phone interview with the auditor. With COVID-19 numbers decreasing, PBMs feel now is the time to resume audits onsite.

PAAS analysts have years of experience assisting pharmacies through onsite audits. Pharmacies can receive a pre-audit consultation with an analyst, in addition to specific PBM trends, state laws that are being targeted, and many other tips that can be provided to support you through your audit. We also offer our Onsite Credentialing Guidelines located on the PAAS Member Portal, to help our members prepare for potential questions that may be asked during the auditor’s visit.

PAAS Tips:

  • Engage PAAS as soon as possible after receiving an any audit notification (including onsite)
  • Log on to the Member Portal to search past Newsline articles for safe filling and billing tips, or submit a question online
  • PAAS FWA/HIPAA Compliance members should review their compliance tasks to ensure the pharmacy is up to date
    • MedImpact is specifically looking for written policies and procedures for FWA when onsite

If you do not have a compliance program, contact PAAS today to explore the PAAS FWA/HIPAA Compliance program. Get complaint today and save $126!

Self-Audit Series #14: DMEPOS Items

Medicare Part B/DMEPOS billing and documentation rules are VERY different from most of your pharmacy claims – if you don’t have a strong grasp of these differences, or a process for handling the documentation, then you are sure to experience significant problems.

PAAS Tips:

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Documentation for DMEPOS items

Standard Written Order (SWO)

  • SWOs must include the following six elements:
    1. Beneficiary’s name or their Medicare Beneficiary Identifier (MBI)
    2. Date of the order must be present
    3. General description of the items – HCPCS code a HCPCS code narrative, or a brand name/model number
    4. Quantity to be dispensed
    5. Practitioner’s name or NPI
    6. Practitioner’s signature
  • Other important items to know:
    • Medicare accepts electronic, faxes and written orders. Telephone and transfer orders do NOT satisfy Medicare requirements
    • Must have SWO in your possession prior to billing claims
    • Not required to have a diagnosis code on the order; however, the correct diagnosis code is needed to appropriately bill the claim
    • As of January 2020, pharmacies may obtain and make note of verbal clarifications
  • See our January 2019 Newsline article Billing Medicare Part B – Nebulizer Drugs for requirements of a valid detailed writer order (DWO) if being audited on a claim with an order written prior to 2020

Proof of Refill Request (PORR)

  • Refill requests include the following four elements:
    1. Name of beneficiary (or representative) making the request
    2. Description of each item requested
    3. Date of refill request
    4. Quantity that beneficiary still has remaining
  • NOT required for items picked up at your pharmacy
  • PORR may not be obtained more than 14 days before exhaustion of current supply or delivered to the patient more than 10 days before exhaustion

Proof of Delivery (POD)

  • POD must include the following six elements:
    1. Beneficiary name
    2. Delivery address
    3. Detailed description of the item(s)
    4. Quantity delivered
    5. Date delivered
    6. Signature of beneficiary or representative
  • Important notes:
    • Date of delivery should match the date of service billed (there is no “return to stock” window)
    • Applies to all DMEPOS dispensing – even when picked up at pharmacy
    • Standard “signature logs” used for PBM audits generally do not satisfy requirements
    • Most common items missing on audit = delivery address, detailed description, quantity
    • Many pharmacies will add duplicate Prescription dispensing label to provide

Medical Records

  • In general, medical records should conform to the following:
    • Be created on or before the prescription order (SWO)
    • Support the underlying diagnosis or condition
    • Be signed by the treating practitioner
  • To prove “continued medical need” of ongoing supplies or rental items, medical records must be “timely” which is defined as a record in the preceding 12 months unless otherwise specified (e.g., high utilization of diabetic test strips requires medical records within previous 6 months)
  • Each DMEPOS product category requires different unique elements
  • Best practice would be to obtain records before dispensing items to patients

Billing for DMEPOS items

  • Medicare billing is based on HCPCS codes (not NDCs) and “units of service” (which varies by product)
  • Many pharmacies utilize software vendors such as OmniSYS and Change Healthcare to convert NCPDP D.0 claim information into an “837 file” that CMS claim processors recognize
  • Many DMEPOS items require “modifiers” to communicate various information
    • Example for diabetic test strip claims (A4253): ‘KS’ indicates that the patient is NOT using insulin, while ‘KX’ indicates that the patient IS using insulin
    • Example for claims billed during the public health emergency that do not meet all Medicare clinical indication requirements should be adding a ‘CR’ modifier to the claim if on or after 3/1/2020 and for the duration of the PHE – See March 2022 Newsline article Medicare not Enforcing Clinical Indications for Certain DMEPOS Categories during the PHE for more information on the ‘CR’ modifier

Dispensing for DMEPOS items

  • Must ensure that the signature date matches the date of service billed on the claim
  • Claim must be billed on the date picked up, or the date sent out for delivery
    • If the dates do not match and you identify this error on your own, you can resolve it proactively via a Reopening without having to request a formal appeal
    • If this error is discovered during an audit, pharmacies must appeal via a Redetermination. During the PHE, pharmacies are allowed to write a note to the medical reviewer asking them to adjust the date billed to match the date picked up

Be sure to utilize all the tools and resources available on your local DME MAC website to ensure you are compliant with Medicare’s billing and documentation rules.

  1. Durable Medical Equipment Medicare Administrative Contractor (DME MAC) websites
  2. Noridian Healthcare Solutions
  3. CGS® Administrators, LLC
  4. Supplier Manual
  5. Local Coverage Determinations (LCDs) that outline billing and documentation requirements that are specific for various items
  6. Documentation Checklists – these are created by the DME MACs to aid suppliers in adhering to rules
  7. Dear Physician Letters – letters written by physicians of the DME MACs that suppliers can provide to local prescribers to education them about documentation requirements
  8. Educational, on-demand webinars on a variety of topics