Medicare Not Enforcing Clinical Indications for Certain DMEPOS Categories During the COVID-19 PHE

On January 31, 2020, the Secretary of the Department of Health and Human Services (HHS) declared a public health emergency (PHE) throughout the United States due to the COVID-19 outbreak. On March 13, 2020, HHS authorized many waivers and modifications regarding Medicare Part B and DMEPOS claims to help prevent gaps in access to care for patients affected by the PHE. Please see below for some waivers and modifications to Medicare Part B and DMEPOS claims that may pertain to your pharmacy if you are a DMEPOS supplier.

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  • The COVID-19 FAQs on Medicare Fee-for-Services Billing has a list of Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs) whose clinical indications are not being enforced during the PHE
  • Two of the many LCDs listed are nebulizers and continuous glucose monitors
  • If there is proof of medical necessity, these items can be billed to Medicare even if the beneficiary does NOT meet all clinical indications
  • If all the coverage criteria are NOT met during the PHE, then those claims must be billed with the “Catastrophe/Disaster related” (CR) modifier attached to the HCPCS code and “COVID-19” narrative to avoid a denial as previously discussed in July 2020 Newsline article Medicare Part B Requires a Claim Modifier if You Are Not Collecting Patient Signatures!
  • It is likely that CMS will come up with an audit plan for DME MACs and other contractors to audit claims billed with a CR modifier
  • Pharmacies using CR modifiers on large volumes of claims could be targeted
  • In addition to the LCD/NCD waivers, the following waivers are also in effect until the end of the PHE
    • Waiver of face-to-face requirements
    • Waiver of proof of delivery signature requirements
    • Replacement of lost, damaged, or destroyed items that cannot be restored
    • Flexibility with telehealth services
    • Verbal orders
  • Pharmacies should use waivers sparingly as the PHE declines
  • Perform a self-audit on your DMEPOS claims (see Self-Audit Series #14: DMEPOS items) – if you find a claim billed due to a waiver and forgot to add the CR modifier, go online, and submit a reopening request to add the CR modifier to the HCPCS code and “COVID-19” narrative
  • If a claim gets audited and is missing the CR modifier, the pharmacy can request a redetermination to add the CR modifier to the HCPCS code and “COVID-19” narrative
  • Many contractors are refraining from auditing pandemic related claims due to waivers, so pharmacies are seeing increased audits on other DME categories that do not have waivers in place such as surgical dressings, urological supplies, ostomy supplies and more
  • To submit a reopening or redetermination request, follow the guidance from your DME MAC

Best Practices for Vaccine Documentation

Without question, vaccine claims are on the rise! Consequently, PAAS National® analysts have recently seen an increased number of PBM audits for these claims. Consider a few best practices to reduce your risk of audit recoupments:

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Billing

Quantity – Submit the correct NCPDP billing unit of each (EA) or milliliter (mL) based on vaccine product

Day Supply – NCPDP recommends that all vaccine claims be submitted as a 1-day supply

Origin Code

  • Submit the origin code in accordance with how you received the prescription
    • 1 – written, prescription obtained via paper.
    • 2 – telephone, prescription obtained via oral instructions or interactive voice response using a phone.
    • 3 – electronic, prescription obtained via SCRIPT or HL7 Standard transactions, or electronically within closed systems.
    • 4 – facsimile, prescription obtained via transmission use a fax machine.
    • 5 – pharmacy, this value is used to cover any situation where a new Rx number needs to be created from an existing valid prescription such as traditional transfers, intrachain transfers, file buys, software upgrades/migrations, and any reason necessary to “give it a new number. This value is also the appropriate value for “Pharmacy dispensing” when applicable such as BTC (behind the counter), Plan B, established protocols, pharmacists’ authority to prescribe, etc.
  • Note that codes 1-4 represent patient-specific prescriptions while code 5 covers various other situations

Prescriber ID

  • Submit the NPI of the prescriber
  • This would be the prescriber of a patient-specific prescription or standing protocol
  • This would be the pharmacist Type 1 NPI (individual) as per state law where pharmacists have prescribing authority or when ordered under PREP Act declaration during COVID-19 pandemic

Documentation

Item Comments Requested in audits
Authority to Administer
  • You may have a patient-specific prescription with all elements required by state law
  • You may have a standing protocol or collaborative practice agreement
  • For situations where you are administering pursuant to a protocol, CPA or PREP Act declaration, PAAS recommends creating a “placeholder prescription” with all normal prescription elements for your files
 Yes
Screening Checklist Not requested by PBMs, however should retain for your records No
Vaccine Administration Record (VAR) Must document every administration (required by law)

Include at least the following:

  1. Date of administration
  2. Vaccine manufacturer
  3. Vaccine lot number and expiration date
  4. Site of injection
  5. Name and title of the person who administered the vaccine
  6. Vaccine information statement (VIS) or EUA Fact Sheet
    • Date printed on the VIS
    • Date the VIS was given to the patient or parent/guardian
 Yes
VIS or EUA Fact Sheet Most current version must be provided prior to each administration (required by law) No

PAAS Tips:

  • Common errors found during audits are wrong quantity billed and missing VAR documentation
  • See CDC website or org for sample forms and additional resources

Billing OTC COVID-19 Tests Brings New Struggles and Opportunities

In addition to the free COVID-19 testing sites nationwide and COVID-19 tests that can be acquired through the federally-established website COVIDTests.gov, private health insurances are required to cover at-home rapid COVID-19 tests at no cost to consumers. As of January 15, 2022, pharmacies are capable of billing up to eight at-home COVID-19 tests per covered individual per month. Along with this opportunity brings about new struggles surrounding how to properly bill an individual’s insurance. Utilizing PBM communications, and guidance published surrounding at-home COVID-19 test billing, PAAS National® created additional resources to assist in proper billing and documentation requirements that PBMs may require.

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PAAS recommends pharmacies have retrievable documentation when billing at-home COVID-19 tests through your pharmacy system. In addition, PBMs such as Prime Therapeutics and Express Scripts have communicated their billing requirements for at-home COVID-19 tests. PAAS developed the Commercially Insured Patient Request and Attestation for OTC COVID-19 Test Billing document to assist with future audits pertaining to billing a patient’s insurance for the testing supplies.

The Commercially Insured OTC COVID-19 Tests Frequently Asked Questions (FAQ) document answers many questions pharmacies may have surrounding how to go about billing the at-home tests, such as if a prescription is needed to bill for an OTC COVID-19 test or who the prescriber will be if a pharmacy initiates a prescription vs. when a pharmacy does not initiate a prescription. The FAQ document also includes a list of known authorized tests which are covered under the OTC Emergency Use Authorization (EUA), albeit not a fully comprehensive list. As stated by NCPA on February 1, 2022, there have been type 1 consumer recalls on at-home tests falsely alleging to be authorized by the FDA. When placing an order for OTC COVID-19 tests, properly vet the distributor and the product to ensure the at-home tests being ordered are an authorized FDA test.

All PAAS produced COVID-19 materials can now be conveniently located under the COVID-19 Resources page on the PAAS Portal. As additional information is released pertaining to at-home COVID test billing practices and other COVID-related topics, periodically visit the portal for the most up-to-date resources.

Four Tips for Navigating Pharmacy Compliance Audits in 2022

by Tracie Acosta, CPh, Published March 11, 2022 by Pharmacy Times

In recent years, the auditing process has evolved into a full-blown investigation, often requiring pharmacies to submit hundreds of pages of documentation

Compliance audits launched by pharmacy benefit managers (PBMs) have long been a cause of frustration for pharmacies, especially independent community pharmacies with limited manpower and resources compared to large chains. This challenge has only magnified since the onset of the COVID-19 pandemic in early 2020.

PBMs have adapted their practices by switching to virtual audits, leaving them with the ability to review more claims than ever before. As a result, pharmacies that are juggling the chaos of audit documentation, vaccine distribution, prescription refills, and a plethora of other responsibilities stand to lose. It’s no wonder that the average audit in 2020 cost pharmacies $23,978, which is 35% more than the annual average over the previous 5 years, according to the pharmacy audit assistance service, PAAS National.

Traditionally, a PBM would simply check that the pharmacy received a valid prescription, dispensed the proper amount according to the prescription, and submitted a claim for the correct amount dispensed. But in recent years, the auditing process has evolved into a full-blown investigation, often requiring pharmacies to submit hundreds of pages of documentation—and auditors can even use minor clerical errors as excuses to deny payments.

As pharmacy compliance audits grow in sophistication, it’s up to pharmacies to remain diligent in monitoring their operations, especially the following aspects of their operations in 2022. Here are some tips for getting ahead of and managing audits in the year ahead.

Continue to read the full article here.

Top 3 PAAS eNewsline Exclusive Articles

Your monthly printed Newsline is only a fraction of the content. PAAS Audit Assistance members can log in to the PAAS Portal each month to view the full Newsline edition with audit prevention tips and timely information on PBM audit tactics.

PAAS Audit Assistance member can explore additional eNewsline articles on the PAAS Member Portal.

PAAS Audit Assistance Admins can also add employees to the Portal so that their whole staff has access to the eNewsline.

Keep your employees informed to increase engagement and lower audit results!

Top 10 PAAS National Articles of 2021

PAAS Audit Assistance members receive a monthly newsletter with new audit tactics and prevention tips. The printed newsletter, PAAS National® Newsline is only a fraction of the content that we put out each month as members have access to additional content online in the Member Portal, in addition to an archive of articles.

The top 10 Newsline articles for 2021 include:

  1. Audit Risk: Ivermectin Used for Treating COVID-19
  2. COVID-19 Vaccine Billing Guidance
  3. Updated Dispense in Original Container Chart
  4. Are You Documenting DUR and Submission Clarification Codes?
  5. Dispensed Quantity is Different from the Prescription – Do I Need Documentation?
  6. HHS Advisory Opinion on Contract Pharmacies Under the 340B Program
  7. COVID-19 Vaccine Administration Audit Risk (Including a New PAAS Resource)
  8. Fraud, Waste, & Abuse and HIPAA Compliance Updates for 2021
  9. “Forwarding” Unfilled Electronic Prescriptions
  10. Victoza® – One Letter Can Cost You!

PAAS Audit Assistance Admins can also keep their employees informed to increase engagement and lower audit results by adding employees to the Portal so that their whole staff has access to the eNewsline.

Caremark® Turns Up the Heat on Proof of Copay Collection Requests

PAAS National® is seeing a rising number of Caremark® audits requesting proof of copay collection. This requested information may be included in a desk, virtual onsite, or invoice audit. The number of claims requested can range from just a few claims to all dates of fill for several prescriptions.

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Having a Point-of-Sale (POS) system may be sufficient for providing proof of copay collection; however, PAAS analysts have seen Caremark® requiring additional documentation to show evidence of payment collection. Providing bank deposits (cash transactions), front and back copies of cancelled checks, and credit card receipts may be necessary.

In addition to proof of copay collection, Caremark® has been known to ask pharmacies to include their policies regarding copay collection and financial hardship, including what documentation is required to determine patient’s financial hardship (i.e., tax returns or approved waiver application). PAAS Fraud, Waste and Abuse and HIPAA Compliance members can reference Section 4.1.5 of their Policy and Procedure Manual for their copay collection policy.

While pharmacies may not be required to collect copays for Medicaid prescriptions, attempts to collect must be made, documented and only waived on a case-by-case basis.

Pharmacies using house charge accounts face additional challenges. Providing itemized invoices showing payments made on the account will likely be required. Written policies and procedures should be in place if charge accounts are used and may be necessary to submit to the PBM.

Secondary payor information (and/or payment) may be necessary when coupons or discount cards are used. Caremark Provider Manual, Section 3.03.03 addresses the use of coupons and other programs. Remember that Medicare, Medicaid and TRICARE prohibit the use of manufacturer coupons and discount programs.

Pharmacies not able to provide sufficient evidence of copay collection not only face full recoupment of claims, but could face termination of contract and risk Fraud, Waste, and Abuse investigations and charges linked to the False Claims Act.

PAAS Tips:

  • See Caremark® 2022 Provider Manual for additional information regarding copay collection:
    • 3.03.03 (coupons)
    • 3.03.04 (proof of payment)
    • 3.03.08 (waivers)
    • 3.03.09 (financial hardship)

Contact PAAS National® at (608) 873-1342 or visit our website, paasnational.com/buy-now for more information on adding our FWA/HIPAA compliance program.

2022 Fraud, Waste & Abuse and HIPAA Compliance Program Updates

PAAS National® continuously monitors legislative and regulatory changes that may impact your Fraud, Waste & Abuse and HIPAA Compliance Program. We keep a close eye on enforcement from the Department of Justice and Office for Civil Rights to help ensure the program meets interpretative standards. Furthermore, PAAS works to keep pace with Pharmacy Benefit Managers as they continue to add credentialing requirements that can be extremely difficult and a significant nuisance to independent pharmacies.

The PAAS National® FWA/HIPAA Compliance Program has implemented changes to ensure pharmacies continue to have a robust program in place. PAAS FWA/HIPAA compliance members can login to the member portal to view the 2022 FWAC and HIPAA Updates.

Administrators should review all Compliance tasks (located in the left-hand navigation on the PAAS Member Portal) at least annually to keep the program up-to-date and in compliance. Section 2.6 Updates of Policies and Procedures of your manual contains information on maintaining open lines of communication and the distribution of changes.

Contact us TODAY at (608) 873-1342 or info@paasnational.com and add FWA/HIPAA for a discounted rate.

“We have been with PAAS for many years and added the FWAC/HIPAA material to our membership and as a compliance officer, I’ve never been more pleased with the program. If you have already made the best choice to have PAAS in your corner, then continue with the best for your FWAC/HIPAA needs.” – Member since 2010 from North Carolina

“PAAS National® Fraud, Waste, Abuse and Compliance educational sessions are unsurpassed. The PAAS National® Policy and Procedure manual that you create for your pharmacy is a must for all pharmacies to have for their staff. All of this keeps your pharmacy up to date with current pharmacy procedures and operations and ensure proper pharmacy practices going forward.” – Member since 2021 from New York

“A pharmacy without the compliance program does not have their bases covered and required work finished. I can sleep at night knowing this program keeps me protected and on task.” – Member since 2009 from Iowa

Humana Compliance Requirements – Training and Exclusion Checks Are Not Enough

PAAS National® analysts have received several questions regarding Humana’s 2022 Notice of Program Requirements. Humana’s Compliance Policy for Contracted Healthcare Providers explicitly states pharmacies must have a compliance program that meets the seven elements outline by CMS, including written policies, procedures and standards of conduct. Per the 2022 Pharmacy Compliance Education and Training Requirements FAQs: “Humana reserves the right to request documentation (e.g., policies and tracking records) confirming that your organization has an effective compliance program that meets the requirements outlined in the Compliance Policy and Standards of Conduct.”

PAAS’ Fraud, Waste & Abuse and HIPAA Compliance program keeps members compliant beyond training and exclusion checking. Since 2009, the program was designed to meet these CMS requirements, with the full support of our expert staff – pharmacists just like you, with years of experience helping community pharmacies with FWA and HIPAA compliance.

If you aren’t a member of FWA/HIPAA and are interested in saving $126 on your membership, please contact PAAS at (608) 873-1342 to become an Elite member.

PAAS Tips:

    1. Members can contact PAAS (608) 873-1342 if you have any questions
    2. See December 2021 Newsline article PBM Provider Manual Updates – What You Need to Know
    3. See August 2021 Newsline article Humana Audit Program Updates

Self-Audit Series #13: Diabetic Test Strips

The 2020 National Diabetes Statistics Report, analyzed data through 2018 and found that there are over 34 million Americans with diabetes (approximately 1 in 10 Americans). Additionally, there are 88 million Americans with prediabetes (approximately 1 in 4 Americans). Based off this data, there are more than 120 million people in the United States that are living with diabetes or prediabetes. Due to the high volume of claims for diabetic test strips, they continue to receive significant attention during third-party audits. Follow the tips below to be prepared if you get an audit.

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Purchasing Requirements

  • PBM contracts require that pharmacies purchase test strips from vendors that are licensed distributors in your state
  • OptumRx® requires purchases from suppliers that have received NABP’s Drug Distributor Accreditation (DDA) (formerly known as “VAWD® Accreditation”)
  • Caremark® and Express Scripts® also require test strips to be purchased directly from the manufacturer or from authorized distributors only.
  • Consider purchasing test strips from one approved wholesaler to make things easier
  • Major test strip manufacturer’s have lists of “authorized distributers” on their websites
  • Beware of secondary wholesalers which are subsidiaries of authorized distributors who may not show up on the authorized list (e.g., River City and Masters)

Billing

  • Make sure that prescriptions have calculable instructions – use as directed is not accepted upon an audit
  • Confirm that you are billing the correct NDC – many test strips have a “retail” version and a “Medicare/Medicaid only” version
  • Verify the NDC billed is for the correct package size – do not bill the #100 count NDC if you are dispensing the #50 count box
  • Dispense only one NDC per claim – you should not dispense 1 x #100 count and 1 x #50 count to equal #150 test strips
  • Dispense the package size that is closest to the total quantity – if the prescription is for #200, dispense 2 x #100 count, not 4 x #50 count; some plans prohibit dispensing smaller packages
  • Submit the accurate days’ supply based on the quantity and instructions
  • If you are billing DMEPOS for Medicare beneficiaries, make sure that you submit the correct modifier to indicate if the patient is using insulin (KX) or not using insulin (KS)
  • Some payers may require a diagnosis code at the time of billing to support the clinical need

Additional Newsline Article References for Self-Audit