Podcast: A Deep Dive into LTC Audits with Trent Thiede

Trent Thiede, President of PAAS National® and host of Amplify Long-Term Care Pharmacy Podcast, Frances Nahas talk all things pharmacy audits, from transitions of care to the complicated (and necessary) role PBMs play. Tune in to learn surprising insight of LTC audits to take your long-term care program to the next level.

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PAAS Defends Community Pharmacies by Engaging DME Medicare Administrative Contractor CGS

In our August Newsline Standard Written Order and Medicare Part B Audit Risks – New Guidance, we shared a few examples some of our members are having on audit results regarding their Standard Written Order (SWO). Beyond writing the Newsline, PAAS National® also reached out and engaged nurse medical reviewers with CGS about our concerns on the three topics below.

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Issue #1: DME MACs state corrections on an SWO must be signed off by prescriber

  • Chapter 5.2.2 of the Medicare Program Integrity Manual states: “While the SWO has a limited number of required order elements, suppliers/providers are permitted to add elements that may provide clarity for issues such as length of need, frequency of use, dosage form/strength, refills frequency, etc. This additional information shall be corroborated by information in the medical record”
    • Section 5.2.2 does not state the prescriber must sign off on any additions or corrections to an SWO. This goes against standard pharmacy practice and conflicts with CMS guidance.

Issue #2: While refills are not a required element on the SWO, if the practitioner writes for refills, they will be honored exactly as specified regardless of the quantity dispensed

  • Medicare allows the initial fill and as many times subsequently for the exact refills indicated on the prescription after which the prescription would be considered expired
  • Example: A pharmacy receives an order for a 90-days supply, plus three refills (i.e., a full year’s worth of medication). If the pharmacy can only bill for one month at a time (Medicare requirement on most DMEPOS items), the pharmacy can only fill off this SWO for a total of 4 fills (likely 120 days), regardless of the total quantity written. Additional fills would be considered unauthorized refills and ineligible for reimbursement, despite standard pharmacy practice.
    • The DME MACs were unable to provide PAAS a citation or reference for their interpretation, stating they do not have the sophistication to track total quantity prescribed over the life of an SWO

Issue #3: OmniSYS memo – “An important Update About Medicare Part B Insulin Coinsurance Reductions and Deductible Waivers” when using insulin in a pump

  • Section 11407 of the Inflation Reduction Act – The purpose of this Change Request (CR) is to implement the Medicare Part B deductible, which is waived for insulin furnished through an item of durable medical equipment and limits the beneficiary coinsurance for a month’s supply of insulin not to exceed $35. The supplier payment is to be adjusted “as necessary” so that Medicare pays for the rest of the amount for the month’s supply of insulin.
  • As of July 1, 2023, suppliers billing between a 31 to 89-day supply or greater than a 90-day supply will continue to encounter days’ supply rejections.
  • OmniSYS will automatically add the new JL or JK modifiers to claims billed as a 90-day supply
    • PAAS’s concern is that the claims processor is rejecting claims with a days’ supply of 31-89, interpreting the MLN literally for the JK and JL modifiers, which does not make sense for insulin being used in a pump. Rarely would the days’ supply work out perfectly to 30 or 90.

While the meeting with the nurse medical reviewers from both jurisdictions B and C at CGS was fruitless, we were able to escalate our concerns to the medical directors at CGS jurisdictions B and C. The directors were very open to discussion and receptive with our concerns regarding the SWO and OmniSYS issues discussed above. The directors have promised to forward our differing interpretations of section 5.2.2 to the CMS division of medical review and update us on any additional CMS guidance. PAAS will keep our members informed as things develop.

Best Practices for Billing Vaginal Creams to Avoid Recoupment

PAAS National® analysts frequently receive questions regarding the proper billing of creams and ointments, an easy audit target for PBMs. This article focuses on vaginal creams due to their high cost, lack of sufficient instructions for use and plan limits that cause pharmacies problems. When a PBM auditor sees a claim for Premarin® or Estrace® vaginal cream, they see dollar signs and often take back 100% recoupment on not just one fill, but multiple refills. To help reduce the risk of an audit recoupment, please review the table and PAAS Tips below.

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Product Package Size Applicator Measurements
Estrace® (estradiol) 0.01% vaginal cream 42.5 grams 1 to 4 grams (1 gram increments)
Premarin® (conjugated estrogens) vaginal cream 30 grams 0.5 to 2 grams (0.5 gram increments)

Here is an example prescription:

  1. Premarin® vaginal cream, quantity: 30 gram, sig: 1 gram vaginally three times weekly
  2. 30 gram ÷ 3 gram per week = 10 weeks or 70-day supply
  3. Don’t assume plan max of 30 days, try to bill as 70-day supply as per estimate
  4. If plan limit is 30 days, then follow the “ILQ process”
  5. Suggest sig on dispensing label of ‘Use 1 gram vaginally three times weekly (70 days)’ to alert patient and pharmacy staff of how long the dispensed product should last

PAAS Tips:

  • PBMs look for calculable instructions (e.g., grams per application or max grams per week/month)
  • Instructions for “pea-sized amount” or “X number of inches” are not sufficient for audit purposes
  • Ensure an accurate days’ supply is submitted on claims – many PBMs will allow > 90 days for these products due to normal utilization
  • These vaginal creams only come in one package size and instructions rarely support a days’ supply of 30
  • Do NOT default the days’ supply to 30
  • See PAAS’ Can You Bill as 30 Days? resource on the PAAS Member Portal (paasnational.com) for step-by-step guidance on the “Insurance Limits Quantity” (ILQ) process
  • Vaginal creams should be treated as “refill on demand” only and NOT included on LTC cycle fill or retail medication synchronization programs
  • Self-audit your vaginal creams for accurate days’ supply and appropriate instructions – refer to our June 2021 Newsline article, Self-Audit Series #5: Topical Prescriptions

PAAS Pit Stop: On-Demand Webinars

Over the last three years, PAAS National®’s President, Trent Thiede, has presented on-demand webinars, ranging from 15 to 45 minutes, to ensure our members gain the knowledge needed to avoid audits, stay abreast on the latest topics in the pharmacy world, and provide information on the more difficult topics in an easy-to-understand manner. During the live events, members are able to ask questions on the topics presented.

PAAS understands the busy and unpredictable nature of your day-to-day pharmacy practice, so we are happy to offer the recorded webinars on the PAAS Portal. It’s a great tool for training and developing staff, as well as keeping up with hot topics in the industry. If you have questions while watching the on-demand webinar, contact PAAS and we’ll be glad to assist.

PAAS strives to pick webinar topics that are relevant to our members, if you have suggestions, please contact us.

PAAS Webinars:

Ransomware Attacks – Is Your Data Protected?

Safeguarding electronic Protected Health Information (ePHI) is as important for a big Fortune 1000 company as it is for independent pharmacies. The HIPAA Security Rule was designed to be flexible to accommodate providers of different sizes and with varying scopes of practice; therefore, the size of your pharmacy does not matter…the Security Rule still applies. That means administrative, technical and physical safeguards are all required to protect patient information.

A recent breach at PharMerica Corporation should serve as a reminder to reassess your pharmacy’s own safeguards to help decrease the risk of a successful malicious cyberattack. According to the PharMerica breach notification posted online in the Maine Attorney General Data Breach Notifications database, the breach affected over 5.1 million people. The attack occurred between March 12 and March 13, 2023 and was discovered on March 21, 2023. A sample of PharMerica’s breach notification letter explained that hackers gained access to patient records including “name, address, date of birth, Social Security number, medications, and health insurance information”. A ransomware gang claimed to be behind the attack and when PharMerica did not pay the ransom to buy back their stolen data, the information was published online.

Administrative safeguards such as firewalls, anti-virus software, log-in monitoring and password management are just several examples of methods to protect ePHI. Here are several questions to consider about your own program:

  • What array of methods does your pharmacy use to safeguard your ePHI?
  • Have you evaluated your vulnerabilities lately?
  • Have new/different threats been identified that require consideration for additional safeguards to be implemented?

PAAS Tips:

  • At least once a year, the Security Officer should perform a thorough assessment of the potential threats, vulnerabilities and the associated risks to the confidentiality, integrity and availability of ePHI
  • Develop and implement policies and procedures to safeguard ePHI
  • PAAS National® Fraud, Waste & Abuse and HIPAA Compliance Program members should review their Policy & Procedure Manual for additional guidance on safeguards; specifically, Section 11 – HIPAA Security and Other Administrative Simplifications and should perform a Risk Analysis at least annually

Automatic Prescription Refill Concerns

Many pharmacies use an automatic refill process to streamline the labor needed to fill prescriptions. Patients tend to have better adherence to taking their maintenance medications when automatically refilled, and inventory management can be smoother as well.

Unfortunately, automatic refills can also lead to waste or abuse if not managed properly.

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This is why many state Medicaid plans do not allow automatic refills for their patients. MO HealthNet was just the latest Medicaid plan to prohibit automatic refills citing the following observations:

  • Participants receiving medications that were discontinued months prior;
  • Multiple strengths of the same medication when the prescriber changed doses but the pharmacy continued to autofill both;
  • Multiple products in the same drug class when the prescriber changes medications, but the pharmacy fills the old and the new medication; and
  • Pharmacies filling “as needed” medications each month, including migraine medications, rescue inhalers, and COVID tests, among others.

Unfortunately, PAAS National® has assisted with audits where the PBM is requesting proof of refill request. They required pharmacies to have a system in place to document that a patient requested a refill and note the date of request. Some of these audits were for Medicaid plans, some were simply audits where the patient had denied requesting the medication be filled possibly due to the patient misunderstanding the request by the PBM. In these cases, it is up to the pharmacy to prove that they filled the medication in accordance with a patient’s wishes.

PAAS Tips:

  • Be aware, state pharmacy regulations may prohibit, or require additional documentation for, automatic refill programs
  • Medicare B requires Proof of Refill Request for supplies that are mailed and delivered, to confirm patient need and proof of exhaustion for previous supplies
    • Contact PAAS if you need a template
  • Avoid putting bulk items like inhalers, insulin, eye drops or topicals on med sync
  • Do not put “as needed” or controlled substance medications on med sync
  • Ensure the refill interval is at ≥ 90% utilization
  • If employing a med sync program, review our August 2022 Newsline article, Medication Synchronization: Possible Concerns
  • Read the September 2022 Newsline article, Automatic Mailing for Part D Patients, for more information

NADAC Survey: What is It and Do I Need to Respond?

Pharmacies that receive a National Average Drug Acquisition Cost (NADAC) Survey frequently contact PAAS National® for information and guidance. While this survey remains voluntary, pharmacies may want to take a minute to understand what the survey is about.

The Affordable Care Act required that Medicaid programs shift pharmacy reimbursement to an acquisition cost-based model. CMS Final Rule (CMS-2345-FC) set a compliance date for State Medicaid Programs to be effective no later than April 1, 2017.

The NADAC file was created to provide pricing files for state Medicaid agencies to utilize when creating their acquisition cost-based pricing methods for Fee-for-service (FFS) Medicaid plans.

CMS has contracted Myers & Stauffer, LC to conduct these retail pricing surveys. Out-patient pharmacies are randomly selected to receive these surveys, requesting invoices for purchases made over a one-month period. The data collected from these invoices are used to update the NADAC file on a weekly basis.

Again, these surveys are currently voluntary, and pharmacies are under no obligation to respond. This however may change with a newly introduced bill, Drug Pricing Transparency in Medicaid Act of 2023 (H.R. 1613). If passed, this bill would not only make the surveys mandatory for pharmacies to respond but includes many updates to ban spread pricing in State Medicaid Plans. PAAS will keep you informed if, and when this bill passes.

PAAS Tips:

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  • NADAC files are published monthly here
  • Consider responding if you are being paid below your cost on Medicaid claims; your actual costs can be added to the survey data
  • Pharmacies may want to consider requesting a Non-Disclosure Agreement from Myers & Stauffer LC
  • Steps to take with your documents if responding
    • Print “Confidential” on each invoice page
    • Only include the documents requested, no PHI should be included
  • Contact Myers & Stauffer LC helpdesk with any additional questions (855) 457-5264

Caremark Invoice Audits – Pharmacy to Pharmacy Purchases

PAAS National® continues to see PBM audits increase as we get further out from the formal end of the COVID-19 Public Health Emergency. One disturbing trend is the number of invoice audits, particularly from Caremark. Oftentimes, Caremark will conduct a “combination” audit where they request copies of prescriptions and signature logs (a traditional desk audit) along with a request for pharmacy invoices that generally cover a 12-month period.

These audits are very large in size and scope, and we have noticed a new twist in enforcement on the invoice audits. Caremark outlines pharmacy network requirements for purchase invoices in the Pharmacy Provider Manual Section 8.05. Caremark states the following,

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For those Covered Items received from other pharmacies, where permitted by and consistent with Law, Provider must obtain and maintain the entire Transaction Statement, Transaction History, and Transaction Information from the selling entities.

This mandate exceeds the federal DSCSA requirements that would otherwise allow pharmacies to make purchases from other pharmacies on an occasional basis under a “specific patient need” exception and NOT require communication of the 3Ts, comprised of Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS). PAAS strongly opposes this requirement and will work with pharmacies to vigorously appeal any such invoice audit discrepancies.

Many pharmacies shop around for the lowest cost of goods and have purchased products from other pharmacies under DSCSA’s specific patient need exemption. Remember that this exemption is intended to permit occasional (not routine) purchases to avert patient harm due to supply chain shortages, as patients may be harmed by not getting access to prescribed therapies. Pharmacies with higher volumes of these purchases may be accused of purchasing outside of the specific patient need exemption and buying for general stock, which is not in compliance with DSCSA. Purchasing from other pharmacies can introduce risk that product obtained is illegitimate and could cause patient harm.

While FDA’s track and trace law (DSCSA) is not yet fully operational and many stakeholders are requesting that FDA delay enforcement (including APhA, NACDS, and NCPA), it seems that Caremark is trying to slap on an enforcement badge and bully pharmacies around in the meantime.

PAAS Tips:

  • Ensure that any pharmacy to pharmacy purchases qualify under DSCSA exemption of specific patient need
  • See December 2022 Newsline article, Pharmacy to Pharmacy Inventory Transfers – Buyer Beware! for additional discussion of risk and best practices for documenting such transactions
  • Please alert PAAS if you are subject to an invoice audit so that we can help you navigate the process as smoothly as possible

Are You Ready for Flu Shot Season? Auditors Are!

It is that time of year again; flu shot season is upon us. As busy as this season can be, we know you do not want to worry if you have all the documentation you need in case of an audit. Make it easy on yourself by ensuring you are ready now by following PAAS National®’s best practices to reduce your risk of audit recoupment.

What you will need for an audit:

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  1. Authority to administer
  • A signed order from an authorized prescriber
  • A signed protocol that is up to date and includes specific vaccination(s) to be administered or a Collaborative Practice Agreement (CPA)
  • When using a protocol or CPA, create a placeholder prescription with all prescription elements
  • In states where pharmacists have independent authority to vaccinate, create a placeholder prescription with all prescription elements
  1. Vaccination Information Statement (VIS)
  • Required to be given to patient prior to each administration
  • Be sure you have the most current VIS forms
  1. Screening Checklist
  • Not requested by PBMs, however should be retained for your records
  1. Vaccination Administration Record (VAR)
  • Date of Administration
  • Name of vaccine administered and manufacturer
  • Lot and Expiration Date of vaccine given
  • Site of administration (i.e. right arm)
  • Signature or initials and title of person administering
  • What VIS form was given
  • Date printed on the VIS
  • Date the VIS was given to the patient or parent/guardian

VAR and VIS forms, and information regarding what the CDC requires for health care providers to record, can be found on the CDC website.

PAAS Tips:

  • Check dates and vaccine types on your protocols to ensure they are up-to-date
  • Have current VIS forms printed for each vaccine you administer
  • Have VAR forms printed and educate all staff on how to complete the forms
  • All vaccines should be submitted using days’ supply of “1” per NCPDP recommendations
  • All vaccines administered via protocol should be submitted with origin code of “5” (pharmacy created) per NCPDP recommendations
  • Be sure correct metric quantity is billed
  • Keep vaccine documents stored in a system that makes access easy in case of an audit
  • When billing for vaccine clinics, DO NOT bill prior to the vaccine being administered
  • You may submit claims after the date of service, but the date of administration must be correct on the claim
  • PAAS has seen pharmacies flagged for billing claims outside regular pharmacy hours – consider billing for vaccine clinics during regular business hours

When Are Final Audit Results Not Final?

Receiving audit results with discrepancies and financial recoupments can be very discouraging. PAAS National® analysts are here to assist you through the appeal process. Audit results do not always provide all appeal options, and you don’t want to miss out on another chance if your initial appeal is denied.

Each PBM has different requirements for appealing discrepancies and different timeframes for when responses must be received. The appeal guidelines can also vary due to State audit laws. Engaging PAAS as soon as possible can make a big difference. PAAS analysts have years of experience with the audit appeal process and can provide information and recommendations to obtain the best possible outcome.

Many pharmacies give up when auditors do not accept appeal documentation and leave the fight too soon – check with your PAAS analyst to ensure you have exhausted all options. One example;

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OptumRx allows pharmacies a one-time opportunity to request a reconsideration with the Pharmacy Audit Review Committee (PARC). This committee is comprised of pharmacists and other professionals that have not previously been involved with the audit.

Here are some considerations for appealing OptumRx audits to PARC:

  1. Reconsideration is only available if pharmacy appealed initial findings
  2. Pharmacies must request an audit review form and instructions by emailing PARC@optum.com
  3. Pharmacies that are under investigation for suspected fraud, waste or abuse or appealing termination are exempt from this reconsideration
  4. Documents for reconsideration must be received within 30 calendar days of final results
  5. OptumRx Provider Manual indicates no new documentation can be submitted to PARC for review, however PAAS recommends providing everything you can as a last-ditch effort to support your claim(s)
  6. Pharmacy may have financial recoupments prior to the outcome of the PARC process
  7. Results from the PARC review can take up to 120 days
  8. Visit the OptumRx Provider Manual, Section VIII Compliance; Fraud, Waste and Abuse; General Training; Audits

PAAS Tips:

  • Engage PAAS early by sending your audits in as soon as you receive them
  • If PAAS did not assist you pre-audit, we can still assist with the appeal process
    • PAAS always wants to see your audit results, good or bad
  • Time matters, so stay on top of audit and appeal deadlines