Updated PAAS National® Dispense In Original Container Chart

Dispensing medications outside of FDA packaging requirements may put your claims at risk of recoupment. Medications sensitive to light and/or moisture may require pharmacies to dispense the medication in the original container. Product testing by the manufacturer will determine if this is required. This information will be listed in the product labeling section How Supplied/Storage and Handling. Because manufacturers submit this language to the FDA for approval, be aware there are inconsistencies in how this information appears for different products. Pharmacies can access this information from the package insert or the FDA’s DailyMed website (https://dailymed.nlm.nih.gov/dailymed/).

Prescription claims submitted to PBMs for an NDC that is required to be dispensed in the original container are an easy target for recoupment when the dispensed quantity does not match the package size. Pharmacies that cycle fill medications or service LTC facilities must be aware of these packaging requirements and dispense appropriately as well.

PAAS National® offers our members a chart of medications with special packaging requirements, see the Tools & Aids section of the PAAS Member Portal.

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The three additions to our chart include:

  1. Carafate® (Sucralfate) 1gm/10mL Suspension
  2. Rybelsus® 3 mg, 7 mg and 14 mg tablets
  3. Tabrecta 150 mg and 200 mg tablets

PAAS Tips:

  • Utilize the PAAS National® Dispense In Original Container Chart, by printing and posting the updated copy in your pharmacy
  • Consider adding special shelf tags to these medications to warn staff of their packaging requirements
  • Obtain authorization from prescribers if quantity prescribed is less than what the package size is
  • Self-audit claims that fall under these guidelines to ensure you are dispensing appropriately

HIPAA Guidance Regarding COVID-19 Vaccination Status in the Workplace

On September 30th, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) released guidance regarding the Health Insurance Portability and Accountability Act (HIPAA) of 1996 Privacy Rule and its application to the workplace, specifically discussing the disclosure and request of COVID-19 vaccination status.

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The Privacy Rule (45 CFR Parts 160 and 164) applies specifically to covered entities (CEs), such as health plans, health care clearinghouses, and health care providers who maintain or transmit individually identifiable health information, called “protected health information (PHI).” The Privacy Rule does not regulate a CE’s or its business associates’ (BA) ability to request the vaccination status of an individual, it regulates how the CE and BAs use and disclose the PHI obtained. The Rule expressly states that a member of the CE’s workforce is not considered a BA and the rule does not prohibit an employer from requesting the vaccination status of its employees, a patient, or a visitor and the Rule does not limit an individual from disclosing their own information to another person. In other words, even though a pharmacy is considered a CE and staff must abide by the Privacy Rule daily when utilizing and disclosing PHI, when the pharmacy is acting in its capacity as an employer the Rule does not regulate its ability to ask employees, customers, or patients about their vaccination status. The employee, customer, or patient might believe they do not have to share this information per HIPAA; however, that is not a valid assertion since HIPAA does not regulate or prohibit an individual from sharing their own information. Outside of HIPAA, there may be other applicable state or federal laws which could overlap HIPAA regulations – refer to your healthcare attorney for additional clarifications.

Additionally, the Privacy Rule does not dictate what information can be requested of its employees as a condition of employment. Even the federal equal employment opportunity laws do not prevent an employer from requiring staff to be vaccinated before entering the workplace, as long as reasonable accommodations are made per the Americans with Disabilities Act (ADA). If an employer maintains confirmation or proof of vaccination, the ADA requires those records be stored separately from the individual’s personnel file. Furthermore, an employer can require each member of its workforce to sign a HIPAA authorization to obtain proof of vaccination directly from a covered health care provider and an employer may require its workforce to disclose their vaccination status to a patient, if asked.

The Privacy Rule does prohibit a CE and their BAs from using or disclosing an individual’s medical records, including vaccination status, to an individual’s employer or other entity unless the individual approves the request in advance, or the release pertains to treatment, payment, or other healthcare operations (TPO). Unless the individual has restricted the release of their PHI, the pharmacy can share the individual’s vaccination status with entities such as the individual’s primary care provider, their insurance company, and the state immunization database without the patient’s consent. For disclosure to an entity outside TPO, patients must first approve the release of their protected information (including vaccination history). Be sure to keep all HIPAA-related documentation for a minimum of six years.

PAAS Tips:

  • PAAS Fraud, Waste and Abuse and HIPAA Compliance members, refer to section 10.5 of your Policy and Procedure Manual for additional information regarding the use and disclosure of PHI and Appendix B for the Request to Access or Release Protected Health Information form.
  • Refer to the OCR’s guidance document for additional scenarios, including vaccine records maintained by schools, disclosure to public health authorities, and hospitals releasing PHI relating to an employee’s vaccination status (including documented side effects of the vaccine) to an employer.

Accepting Gifts Can Be an FWA Violation

The U.S. Department of Justice issued a press release on September 30, 2021, outlining that a former public official accepted “gratuities” (aka gifts or kickbacks) in exchange for referring business to a specific outside vendor. The employee was sentenced to eight months in federal prison and required to pay almost $8,000 in restitution.

According to the press release, David Laufer worked at Walter Reed Medical Center and was the Chief of the Prosthetics and Orthotics Department. Mr. Laufer reportedly accepted thousands of dollars in cash and other gifts such as airline tickets, lodging and entertainment tickets from Pinnacle Orthopedic Services in exchange for steering business from 2012 to 2016. Mr. Laufer repeatedly hid these outside compensations from his employer despite being required to complete annual Confidential Financial Disclosure Forms intended to identify and deter this type of activity. Mr. Laufer also denied receiving any benefits from Pinnacle during interviews with federal agents as part of a corruption investigation at Walter Reed.

The press release makes it very clear that Mr. Laufer was fully aware that his activity was wrong and made multiple explicit attempts to avoid detection. Despite the efforts of his employer to prevent (through disclosure forms) and detect (through investigation) this bad actor was able to break the rules.

Just think how bad things would have been had his employer (the federal government) not had certain FWA prevention/detection elements in place.

PAAS Fraud, Waste & Abuse and HIPAA Compliance members have an electronic Code of Conduct, Business Ethics and Conflicts of Interest Policy that employees must sign annually as well as a policy about Receiving Gifts and Entertainment-Conflicts in Section 3.2.2 of the FWAC/HIPAA Policy and Procedure Manual.

PAAS Tips:

  • PAAS FWA/HIPAA members can review Policy & Procedure Questionnaire #5 and #6 to ensure their Receiving Gifts or Entertainment Policy is current
  • Pharmacies that do not utilize the PAAS FWAC/HIPAA program should evaluate their existing policies to ensure they are robust

Telemedicine Audits: Are Your Prescriptions Legitimate?

During the Public Health Emergency, telemedicine has become a convenient, and much more common, way for patients to communicate with their healthcare team; especially when patients and healthcare facilities are wary of in-person appointments. Unfortunately, telemedicine also continues to be an easy target for bad actors, with pharmacies being caught in the middle.

In August, Prime Therapeutics reported that telemedicine schemes contributed to a 60% increase in reported false claims during 2020. In one investigation, Prime pointed to a pharmacy’s use of “high-risk, low-value” products that allowed a pharmacy to transmit $300K in their first month of doing such business. This pharmacy was terminated from the network, reported to the Board of Pharmacy and Department of Insurance, and had funds recouped.

Another example is the DEA’s announced criminal charges in a September 17, 2021 press release against 138 defendants across 31 federal districts for alleged participation in fraud schemes including $1.1 billion in telemedicine fraud. Court documents noted that telemedicine executives paid doctors and nurse practitioners to order unnecessary equipment, tests, and pain medications either without having any patient interaction or after a simple phone call with the patient whom they had never met or saw for a medical purpose. Fraudulent claims were then submitted to Medicare and other government insurers, including for telehealth consultations that did not happen in the way they were represented to the insurers. Profits made off these schemes were found to have been spent on luxury items like yachts, vehicles, and real estate.

How does a pharmacy avoid the bad actors in telemedicine and still help their legitimate patients? Background research may be necessary to understand whether prescriptions were generated from a real patient-prescriber relationship and are medically necessary. The following items should be considered before dispensing any telemedicine prescription.

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Prescription:

  • Does the prescription conform to all state and federal laws?
  • Is the prescription a template form?
    • Is every prescription for the same drug, quantity, directions, and refills regardless of a patient’s individual treatment needs?
    • Are the drugs listed all high-cost products and/or have clinically appropriate lower cost alternatives?
    • Does the prescription include substitution cascades or overly broad substitution allowances without consultation with the prescriber needed?
    • Forms with pharmacy branding can lead to problems with patient steering/patient choice laws.
  • How many items are prescribed?
  • Why did the prescription come to your pharmacy?
    • Is this a regular patient of yours?
    • Was the patient referred to your pharmacy by the prescriber?
    • Is there an intermediary routing the prescription to you like a marketing company or a pharmacy that never fills prescriptions but only transfers them out?
  • How did the prescription come to your pharmacy?
    • Facsimile? E-prescription?
    • Transfer?
    • Email/Drop Box are red flags

Patient:

  • Is this a regular patient?
    • If not, where is their regular pharmacy?
    • Why did their prescription come to you?
  • Are you filling all the patient’s medications or just the telemedicine ones?
  • Did the patient request the medication be filled?
    • Some PBMs are requiring proof that the patient requested a medication be filled in the form of a documented conversation with the patient by the pharmacy.
  • Why is the patient utilizing telemedicine?
    • Is the patient in a rural area with little access to healthcare?
    • Is the patient being treated by a specialist not available locally?
    • Online surveys or telemarketing calls are a red flag.
  • Is there a legitimate patient/prescriber relationship?
    • Does the patient regularly see this prescriber?
    • Does the patient live in the same area where the prescriber’s office is located?
    • Would you be able to obtain medical records to validate this relationship?

Prescriber:

  • Is this the patient’s regular prescriber or healthcare system?
  • Is there a legitimate patient/prescriber relationship (see above) and could you prove it if asked?
  • Is the prescriber licensed in the state where the patient resides?
  • Is the medication prescribed within the prescriber’s scope of practice?
  • How were healthcare services provided?
    • Video chat?
    • Simple telephone call?
  • Who paid the prescriber for the telemedicine encounter/visit?
    • Patient or health plan?
    • If the pharmacy or a marketing company paid for the visit, this could be seen as an illegal kickback.

Further exemplified by the US Department of Health and Human Services-Office of Inspector General report issued October 18, 2021, 84% of Medicare beneficiaries who received telehealth services had an established relationship with the provider prior to the telehealth visit.

Finally, if your pharmacy does fill prescriptions for telemedicine, and you determine the prescriptions are legitimate, you also need to follow any state Boards of Pharmacy pertaining to mailing or delivery of prescriptions. This includes confirming if your pharmacy needs to be licensed in a state other than your own that you may be shipping medications to and within PBM contractual limits that may prohibit mailing or delivery outside a certain mile radius of your pharmacy.

LIVE WEBINAR NOV. 18: PBM FWA Trends and COVID-19 Vaccine Audit Risks

Join President of PAAS National®, Trenton Thiede, PharmD, MBA for a LIVE webinar “PBM FWA Trends and COVID-19 Vaccine Audit Risks” on November 18, 2021 from 2-2:30pm CT as he discusses:

  • Who We Are and How We Help
  • PBM Fraud, Waste and Abuse (FWA) Trends
  • COVID-19 Vaccine Audit Risks
    • Documentation Requirements
    • Additional Doses for Immunocompromised
    • Booster Doses for qualified patients
    • Medicare at-home patients
  • Pandemic related PBM waivers/concessions

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.

PREP Act Ninth Amendment – Overview and Audit Guidance for Subcutaneous REGEN-COV

The ninth amendment to the Public Readiness and Emergency Preparedness (PREP) Act was published in the Federal Register on September 14th, 2021, which granted pharmacists the authority to order and administer COVID-19 therapeutics and qualified pharmacy technicians and pharmacy interns to administer COVID-19 therapeutics under the supervision of a pharmacist. The PREP Act only covers COVID-19 therapeutics by subcutaneous, intramuscular, or oral administration—therefore, IV infusion would not be covered under this amendment.

At the time of publishing, only one COVID-19 therapeutic is available for administration under the ninth amendment of the PREP Act. The co-formulated solution, REGEN-COVTM, qualifies because it has FDA emergency use authorization (EUA) for administration via subcutaneous injection in addition to IV infusion. REGEN-COVTM contains two monoclonal antibodies (mAbs), casirivimab and imdevimab, and is authorized for the treatment of certain patients with COVID-19 and for post-exposure prophylaxis in eligible patients.1,2

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proved Use1,2 Coverage Criteria1,2,3,4 Dosage1,2,5
Treatment of COVID-19

ICD-10 Code

U07.1

ALL MUST APPLY:

  • Mild-to-moderate COVID-19 symptoms within 10 days of onset without requiring hospitalization or oxygen supplementation due to COVID-19 (or requiring more oxygen than baseline)
  • Adult or pediatric patient (≥ 12 years old and ≥ 40 kg)
  • Positive results of direct SARS-CoV-2 viral testing
  • High risk for progressing to severe COVID-19, including hospitalization or death
600 mg casirivimab + 600 mg imdevimab

IV infusion is preferred, but subcutaneous injection is authorized when infusion is not feasible or would delay treatment.

Post-Exposure Prophylaxis

ICD-10 Code

Z20.822

ALL MUST APPLY:

  • Adult or pediatric patient (≥ 12 years old and

≥ 40 kg)

  • High risk for progressing to severe COVID-19, including hospitalization or death
  • Not fully vaccinated -OR- not expected to fully respond to vaccine (i.e. immunocompromised)
  • Had close contact with an infected individual per CDC criteria -OR- is at high risk for exposure to an infected individual due to infection in other individuals in same institutional setting
INITIAL EXPOSURE

600 mg casirivimab + 600 mg imdevimab

REPEAT EXPOSURE

Patients with repeat exposure expected to last more than one month may receive additional doses once every 4 weeks for the duration of the ongoing risk

300 mg of casirivimab + 300 mg of imdevimab

1FDA EUA for REGEN-COVTM, September 9, 2021. https://www.fda.gov/media/145610/download. (Accessed September 13, 2021).

2FDA Fact Sheet for Health Care Providers EUA of REGEN-COVTM (casirivimab and imdevimab). September 2021. https://www.fda.gov/media/145611/download.  (Accessed October 12, 2021).

3NIH Anti-SARS-CoV-2 Monoclonal Antibodies Treatment Guidelines. August 4, 2021. https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/. (Accessed September 27, 2021).

4Close Contact per CDC criteria:  https://www.cdc.gov/coronavirus/2019-ncov/php/contact-tracing/contact-tracing-plan/appendix.html#contact. (Accessed September 29, 2021).

5REGEN-COVTM: Subcutaneous Injection Instructions for Healthcare Providers COMBATCOVID.HHS.gov. July 28, 2021. https://www.phe.gov/emergency/events/COVID19/therapeutics/Documents/REGEN-COV-SubQ-FactSheet-July2021-508.pdf?utm_medium=email&utm_source=govdelivery. (Accessed October 12, 2021).

High-Risk Conditions1,2,3
  • Older age (e.g., age ≥65 years old)
  • Obesity or being overweight (adult with BMI >25 kg/m2, or if age 12-17, BMI ≥85th percentile for age and gender based on CDC growth charts)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Cardiovascular disease (including congenital heart disease or hypertension)
  • Chronic lung diseases (e.g., COPD, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
  • Sickle cell disease
  • Neurodevelopmental disorders (e.g., cerebral palsy)
  • Conditions with medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies)
  • Having a medical-related technological dependence (e.g., tracheostomy, gastrostomy, positive pressure ventilation [not related to COVID-19])
  • Other conditions/risk factors making the patient high risk for severe COVID-19 (e.g., race, ethnicity) – health care providers should consider the benefit-risk of treatment for each patient

*Additional conditions can be found on the CDC’s COVID-19 Underlying Conditions or People with Certain Medical Conditions webpage

1FDA Fact Sheet for Health Care Providers EUA of REGEN-COVTM (casirivimab and imdevimab). September 2021. https://www.fda.gov/media/145611/download.  (Accessed October 12, 2021).

2CDC. COVID-19 Underlying Medical Conditions. May 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. (Accessed October 12, 2021).

2CDC. COVID-19 People with Certain Medical Conditions. Aug 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. (Accessed October 13, 2021).

When billing REGEN-COVTM, request reimbursement only for the administration fee (aka incentive amount) since the therapeutic agent is provided to the pharmacy at no cost by the federal government. To bill Medicare, the pharmacy must be enrolled as a Part B provider and utilize a medical billing intermediary. For claims billed to plans other than Part B, REGEN-COVTM may or may not be covered by either the pharmacy or medical benefit and cost-sharing is possible. Based on guidance from CMS, below are the billing codes for REGEN-COVTM (NDC 61755-0039-01; 10 mL vial).

sage of casirivimab + imdevimab Medicare Benefit
Drug HCPCS Code Administration HCPCS Code Administration Code Description Incentive Amount*
600 mg + 600 mg

(1,200 mg total)

Q0244 M0243 Outpatient initial SubQ injection and post-administration monitoring $450
600 mg + 600 mg

(1,200 mg total)

Q0244 M0244 Home or residence initial SubQ injection and post-administration monitoring in the home or residence $750
300 mg + 300 mg

(600 mg total)

Q0240 M0240 Outpatient subsequent repeat doses SubQ injection and post-administration monitoring $450
300 mg + 300 mg

(600 mg total)

Q0240 M0241 Home or residence subsequent repeat doses SubQ injection and post-administration monitoring in the home or residence $750

*This rate covers the administration fee plus the minimum required 1-hour post-injection clinical observation period

PAAS Tips: 

  • Robust documentation is extremely important – be audit-ready by having all the following for each claim:
  1. A placeholder hardcopy
  2. Confirmation of the patient’s eligibility with a signed attestation (COVID-19 treatment also requires valid test results)
  3. An administration log signed and dated by the patient, pharmacist, and staff who administered the therapeutic agent

Stark Law and Anti-Kickback Violations –Indictments Handed Down for Medically Unnecessary Claims

According to a September 17, 2021 press release from the Department of Justice (DOJ), a podiatrist was indicted for defrauding Medicare and Medicaid “by prescribing and dispensing medically unnecessary foot bath medications.” The podiatrist owned a foot clinic along with several in-house pharmacies. When the doctor wrote prescriptions, which were subsequently filled at an in-house pharmacy, he benefited financially from the “drug cocktail” prescribed – the higher the price of the cocktail, the higher the profit for the podiatrist. The article explains the “cocktails included capsules, creams, and powders that were not indicated to be dissolved in water and some of which were not water soluble.” To illustrate how expensive these “medically unnecessary” prescriptions were, over one year, Medicare paid the pharmacy over $18,000 for a single patient’s claims. The podiatrist faces up to 50 years in prison for his scheme to defraud Medicare and Medicaid.

Less than a month later, on October 4, 2021, the DOJ released another statement regarding medically unnecessary foot soaks. In this case, a federal grand jury indicted a pharmacist for allegedly utilizing a marketing company to solicit prescriptions for “foot bath” medications, paying the marketing company kickbacks by providing a percentage of the profit gained off each prescription obtained through their service, knowingly filling prescription which were medically unnecessary, and knowingly filling prescriptions where a valid patient/provider relationship was not established. The pharmacist faces one count of health care fraud and three counts of violations of the Anti-Kickback Statute [42 U.S.C. § 1320a-7b(b)]. Willingly incentivizing prescribers or patients by directly or indirectly providing remuneration is a clear violation of the Anti-Kickback Statue which could result in exclusion from all Federal health care programs, criminal penalties, and monetary penalties including up to three times the amount of the kickback.

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Both cases are good reminders of the importance of the relationship between the patient, prescriber, and pharmacy as well as the medication itself and whether it is being used for a medically acceptable indication via the appropriate route of administration.

Being aware of the prescriber/pharmacy relationship is important due to the Physician Self-Referral Law, better known as the Stark Law. If a physician or a member of the physician’s immediate family has a financial relationship with a pharmacy and the prescriber refers a patient to that pharmacy, there is a potential violation of the Stark Law. The law also prohibits billing an item as a result of the prohibited referral. Additional information, including covered items or services and exceptions can be found on CMS.gov or within section 1877 of the Social Security Act (42 U.S.C. § 1395nn).

The relationship between the medication prescribed, the route of administration, and the indication for use should also be considered prior to dispensing. Claims billed under federally funded plans for prescriptions utilized for non-FDA approved indications and for administration by non-FDA approved routes (e.g., topical antifungal cream dissolved in a foot bath) may be subject to recoupment. These claims may be flagged due to lack of supporting evidence for use in Part D compendia. PAAS National® analysts continue to see enforcement of this policy.

PAAS Tips:

Vaccinating Outside of Approved COVID-19 Emergency Use Authorization Has Legal Ramifications

As reported in a September 27, 2021 article by the US Attorney’s Office, the owner of a pharmacy in Juana Díaz, Puerto Rico, “knowingly and willfully” administered vaccine outside of the Emergency Use Authorization (EUA) and subsequently billed Medicaid for the claims. Twenty-four children between 7-11 years of age were vaccinated with the Pfizer-BioNTech COVID-19 vaccine.  The current EUA is solely for the age group of 12-15 years of age, with patients 16 years or older FDA-approved. Pharmacies are required to follow the requirements pertaining to COVID-19 vaccine administration set forth by the FDA, which includes any EUAs in place. Due to the violations, the owner was charged with “participating in a felony conspiracy to convert government property and to commit health care fraud”, to which they plead guilty. For the guilty plea, they voluntarily forfeited their right as a provider for all federal health care programs for five years and returned the reimbursement paid to the pharmacy by the illegitimate Medicaid claims to the United States. In addition, they face up to five years in prison, a fine of up to $250,000, and three years of supervised release.

Due to the seriousness of administering COVID-19 vaccine outside of FDA guidance, this case reiterates the importance of confirming patient eligibility. Due diligence must be performed to substantiate the patient receiving a vaccine dose, including an additional “third” or booster dose. Short of obtaining the patient’s medical record, utilizing PAAS’ COVID-19 Vaccine Self Attestation document, located on the PAAS Portal under Tools & Aids for PAAS Audit Assistance members, will help support a vaccine dose was appropriately given. For more information PAAS Audit Assistance members can refer to the October 2021 Newsline article, COVID-19 Vaccine Administration Audit Risk.

MedImpact is Turning Up the Heat on FWA Investigations

PAAS National® has recently received several FWA audit results requiring the pharmacy to submit additional, and arduous, supporting documentation. Pharmacies need to be aware of the audit risks for medications with high Average Wholesale Prices (AWP) and narrow FDA approved indications (e.g., Pennsaid®). Significant time and effort must be put forth by the pharmacy, prescriber and potentially the patient, to support these claims.

MedImpact FWA audit results are requesting numerous items to support the claims submitted by the pharmacy. Important to note, these results have included many claims that were never paid by the plan. Any claim submitted to a PBM can be requested for audit, even if rejected at point of sale. Clearly these FWA audits are not focusing solely on financial recoupment, but also suspicious conduct by the pharmacy (i.e., test claims). Keep the following in mind:

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  1. Prescriptions transferred from a pharmaceutical hub are under scrutiny. Claims for high AWP medications, with an origin code of 5, are easy claims for a PBM’s algorithm to flag. MedImpact results have come back to pharmacies requesting medical records to show proof of a valid patient/prescriber relationship and to support the necessity of the medication – often difficult to obtain. The audit results have also requested proof the patient authorized or requested these transferred prescriptions be filled prior to adjudication.
  2. Patient’s medication and pharmacy history are also being tracked by MedImpact during these audits. Prescription claims for patients starting on a high AWP formulation, versus potential lower cost therapies, are requiring a prescriber attestation with justification (again, not always easy to obtain). Pharmacies filling prescriptions for the first time for a patient, and only filling these high AWP medications, have been required to provide a written explanation of how these prescriptions were obtained.

With the current public health emergency, pharmacies must be diligent in verifying the legitimacy of telemedicine prescriptions, especially for high AWP medications. See the June 2019 PAAS Newsline article, Telemedicine: Questions to Consider from an Audit Perspective for more information.

Are You Violating PBM Return to Stock Policies? (including New PAAS Chart)

PAAS National® continues to see pharmacies losing money due to violating PBM Return to Stock policies. Each PBM sets a timeframe that unclaimed prescriptions must be reversed and returned to stock. Full recoupment of the claim can occur when a PBM discovers prescriptions are dispensed to patients outside this timeframe. Staying up to date on Return to Stock requirements is imperative. PAAS has a chart available on the PAAS Member Portal (portal.paasnational.com) in our Tools & Aids section so you can stay up-to-date on these policies.

The strictest Return to Stock Policy is 10 calendar days. Pharmacies that currently have a policy for 14 days are running the risk of full claim recoupment from these specific PBMs.

Recoupments are preventable if pharmacies follow through on this very important task. PAAS Fraud, Waste & Abuse and HIPAA Compliance Program members have a customized policy in their manual.

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PAAS Tips:

  • Review and update your pharmacy policy for unclaimed prescriptions and make necessary changes to comply with strict PBM requirements, Section 4.1.1 Unclaimed Prescriptions of your PAAS FWA/HIPAA Compliance manual
    • Review and provide notice to staff of any updates/changes made to current policy.
    • Members may also refer to Appendix B of the manual for the Unclaimed Prescription Reversal Log. This is a helpful tool to assist pharmacies in completing this task.
    • Documenting when the task has been completed provides support that your pharmacy is following their FWA program.
  • Check with your software vendor on the ability to run reports to show prescriptions waiting to be picked up > 10 days
  • Software vendors may be able to set your point-of-sale system to deny the ability to sell past 10 days
  • Assign Return to Stock procedures to one person and allocate time to complete
  • See the June 2021 PAAS Newsline article, Would Your REMS Prescription Pass an Audit? for REMS dispensing and timeframe requirements
  • Be sure to review additional areas where waiting prescriptions are kept (e.g., refrigerator, special order shelf, or an overstock shelf)
  • Partial and LTC prescriptions also fall into these timeframe requirements

Not a PAAS Fraud, Waste & Abuse and HIPAA Compliance Program member? Contact PAAS today at (608) 873-1342 or info@paasnational.com and save $120 by combining services.