On March 13, 2020, the Secretary of the Department of Health & Human Services (HHS) authorized waivers under Section 1135 of the Social Security Act to relax certain administrative rules to ease burdens on Medicare providers and suppliers to more easily provide care during the COVID-19 pandemic. The “1135 blanket waivers” include, among other things, waiving the enrollment fee for Medicare B Providers for those pharmacies that want to provide COVID-19 testing and the requirement to obtain patient signatures for proof of delivery for DME Supplies such as diabetic test strips. These waivers are retroactive to March 1, 2020 and are effective until the end of the emergency declaration.
On April 6, 2020, CMS issued Interim Final Rules with Comment (CMS-1744-IFC & CMS-5531-IFC) and the DME Medicare Administrative Contractors (MACs) issued bulletins in late May explaining that suppliers must include a “CR” modifier and include a narrative of “COVID-19” for claims where patient signatures were not obtained as proof of delivery. Claims that do not include the modifier and narrative may be subject to denial.
Here is an excerpt from the DME MAC joint bulletin:
‘Suppliers should continue to use the appropriate modifiers, including the KX modifier where applicable, for all HCPCS codes included in the NCDs and LCDs listed above. In addition, the CR modifier (CATASTROPHE/DISASTER RELATED) should be added to the HCPCS code(s) billed. Finally, suppliers are instructed to enter “COVID-19” in the NTE 2400 (line note) or NTE 2300 (claim note) segments of the American National Standard Institute (ANSI X12) format or field 390-BM of the National Council for Prescription Drug Program (NCPDP) format. These abbreviations may also be used in Item 19 of the CMS-1500 claim form.’
If your pharmacy dispensed DMEPOS items and did not obtain a patient signature as proof of delivery on or after March 1, 2020, then you must include
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this CR modifier and COVID-19 narrative.
If you have already dispensed claims without this CR modifier and COVID-19 narrative, then you should file a reopening with the DME MAC to ensure that these claims are not subject to audit recoupments in the future. If you are unable to file a reopening and subsequently have claim denials during an audit, you will still have the full appeal process available.
PAAS has reached out to both DME MACs and they have confirmed that pharmacies should submit reopenings to adjust the necessary claims to include both the CR modifier and a narrative stating “COVID-19”.
PAAS Tips:
- We suggest that pharmacies contact their DME claims processor (such as Change Healthcare, EZ DME, or OmniSYS) for technical support on how to include the CR modifier on appropriate claims
- Pharmacies should contact their local DME MAC (CGS or Noridian) for assistance with filing claim reopenings
- Reopenings may be available by telephone, in writing or electronically on the DME MAC portal
- Reopenings may be completed within one year of claim submission
- CGS Jurisdiction B (844-240-7490), Jurisdiction C (866-813-7878)
- Noridian Jurisdiction A (866-419-9458), Jurisdiction D (877-320-0390)
- For more information, you can review:
Nine Pharmacists Charged in $12 Million Fraud Related to Invoice Shortages
Nine pharmacists were recently indicted on felony charges in a $12.1 million health care fraud scheme according to a June 17, 2020 U.S. Department of Justice press release. The licensed pharmacists and pharmacy owners in Detroit and southern Ohio are alleged to have billed Medicare, Medicaid and Blue Cross Blue Shield for medications that were neither purchased nor dispensed, resulting in invoice shortages. Additionally, they are alleged to have provided kickbacks to prescribers, waived patient copays and billed claims for medications purportedly dispensed to beneficiaries after their death.
Headlines like these are the fuel that PBMs use to ramp up invoice audits. While these examples represent a very small minority of pharmacists, they tarnish the reputation of independent pharmacies nationwide.
PAAS Tips:Join today!
- Review your purchasing, billing and documentation procedures to ensure that you are prepared should the inevitable invoice audit happen at your pharmacy
- Consider performing a mock audit as discussed in the January 2020 article Self-Audit Series #12: Invoice Audit to identify any discrepancies now which will provide your pharmacy the opportunity to fix the problem prior to an official audit
- Notify PAAS immediately of any invoice audit so that we can help guide you through a comprehensive response
Foot Bath Prescriptions – MedImpact is Now the Fifth PBM Investigating
PAAS National® has alerted members through several Newsline articles of an increase in audits with Prime Therapeutics®, Caremark®, OptumRx® and Express Scripts® investigating foot bath prescriptions. MedImpact® has now jumped on the wagon as well. Topical products and injectables are commonly flagged for high quantities and dollar amounts. PBMs speculate these items are being used off-label due to the large quantities dispensed; and commonly seen in foot bath treatments.
Caremark® sent out provider manual updates for 2020 prohibiting the dispensing of high quantities or high volumes of drugs within a certain category (e.g. topical or dermatological products). Caremark® will monitor claims monthly and if a pharmacy bills 25% or more (in number of claims or dollars) of items on the aberrant product list, the pharmacy will be in a breach of contract. This list can be found on the Caremark Pharmacy Portal.
OptumRx® will mark foot bath prescriptions with a discrepancy code of CLN = no documentation to denote clinical appropriateness was validated.
Express Scripts® has sent out investigative letters referencing section 7.1 of the provider agreement. The pharmacy must respond by completing responses to questions in a letter.
Now, MedImpact® is issuing results with full recoupments on medications used in a foot bath. Their comments are: “Quantity and directions for use of drug appear to be for use in a foot bath. No clinical documentation or evidence exists to substantiate the clinical appropriateness of using this drug in a foot bath. CMS, in collaboration with the I-MEDIC, indicates Topical products are not the standard of care in treatment of foot infections such as diabetic ulcers, and could be actively harmful to the healing process. Further, the purported indications of use of these combinations used in this manner, may not be medically accepted indications (MAIs) and are, at best, investigative and experimental treatments.”
PAAS Tips:
BEWARE: Virtual On-Site Audits Are Coming!
If you haven’t already noticed, most of the PBMs have resumed auditing practices and started issuing on-site audits the first week of August; however, these are not the on-site audits that you are used to. To practice social distancing and protect your staff (and theirs) most PBMs and audit companies have revised these audits as “virtual” and borrowed some elements from traditional desk and on-site audits to create a new Frankenstein’s monster that shifts a large burden onto pharmacies.
While each PBM/audit company has their own unique nuances for these virtual audits, here are some general trends.
Elements from traditional on-site audit method:
Elements from traditional desk audit method:
Ozempic®– Bill It Right!
Ozempic® is an injectable used to improve glycemic control in adults with type 2 diabetes mellitus and is available as 2 mg in a 1.5 mL (1.34 mg/mL) pre-filled, disposable pen injector. Chart available on our eNewsline.
Ozempic® is dosed once weekly. The starting dose is 0.25 mg once weekly for 4 weeks, then increasing to 0.5 mg once weekly. If additional blood sugar control is needed after at least 4 weeks at 0.5 mg , the dosage may be increased to 1 mg once weekly. Due to the confusing billing units (mL) and titration schedule, billing can be challenging. Based on how each patient responds to treatment and their goals, there are a few different clinical scenarios that may occur following the initial 4 weeks on 0.25 mg. See our eNewsline for three patient scenarios.
PAAS Tips:
Defense Health Agency Money Grab for 2015 Prescriptions Involves Over 300 Pharmacies
June delivered a bombshell for over 300 pharmacies when Express Scripts recouped payment for TRICARE prescriptions dating back to 2015. These recoupments occurred before pharmacies were even notified, leaving many struggling to make payroll and pay wholesalers – in the middle of a Pandemic.
This was not your garden-variety audit, but rather an investigation of the pharmacies by the Defense Health Agency, Office of Program Integrity (DHA-PI). Pharmacies were not requested to produce any documentation in advance of the recoupments. This enforcement action was a result of DHA-PI’s inability to establish a valid patient-prescriber relationship (PPR), deeming the prescriptions written by these prescribers invalid.
Primarily hormone replacement therapy compounds, these prescriptions are not the pain and scar cream prescriptions that were wrought with fraud during that time (many averaging just $40/claim). Due to the absence of a billable office visit from the prescriber in the preceding year, DHA-PI concluded that a valid PPR did not exist – dismissing several plausible explanations. Most prescribers were local to the pharmacy and were prescribing non-compounding medication as well (which are not currently recouped). The lack of due process with this investigation is alarming and should concern all pharmacies.
The same week of the original notice, PAAS National® spoke with Express Scripts and DHA-PI to obtain additional details and help chart a course of appeal. We hosted a live webinar (available on the PAAS Portal) to share information and educate pharmacies on what was taking place. Keeping our members informed on the most up to date information as it becomes available to fight these recoupments is our priority. Partnering with NCPA and the Alliance for Compounding Pharmacies (APC), we continue to advocate and have conversations with DHA-PI and ESI; last occurring July 15, 2020.
While the statement of patient-prescriber relationship is not often brought up during audits, Express Scripts did add information to Section 10, the TRICARE portion of their Provider Manual in 2017. Section 10.1.14 of the manual states it is the pharmacy’s responsibility to validate the patient-prescriber relationship if the prescriber is from outside the immediate retail pharmacy service area. Notably, pharmacies may also not be aware that TRICARE’s Return to Stock Policy is 10 days, which differs from Express Scripts 13-day policy. Having a separate section in the Express Scripts Provider Manual for TRICARE can make it very easy for pharmacies to overlook. PAAS encourages all pharmacies to take a closer look at Section 10 for TRICARE requirements.
Authorized Distributors for Diabetic Test Strips
Invoice audits focusing on diabetic test strips are common in the PBM world. PAAS National® believes the PBMs and manufacturers have two purposes for requesting these invoice audits. They are checking for inappropriate billing practices (wrong NDC) and inappropriate sources of inventory (unauthorized distributor).
The newest audit PAAS has seen is coming from manufacturers of test strips that offer rebate contracts with pharmacies for Medicare/Medicaid claims. These audits are very similar to other PBM invoice audits, in that they request invoices from authorized distributors for test strips dispensed during the specified timeframe. Since the manufacturer knows the number of rebates paid, they can easily identify potential shortages. Pharmacies without a valid explanation will be required to repay their rebates and will potentially lose their ability to purchase Medicare/Medicaid-only test strips.
Caremark® and Express Scripts® require test strips to be purchased directly from the manufacturer or from authorized distributors only. Manufacturer rebate agreements also have these same requirements. Purchasing diabetic test strips from unauthorized distributors puts your pharmacy at risk of audit recoupments, violation of provider agreements and possible network termination.
PAAS Tips:
PAAS Audit Assistance members can view the full article on our eNewsline.
Medicare Part B Requires a Claim Modifier If You Are Not Collecting Patient Signatures!
On March 13, 2020, the Secretary of the Department of Health & Human Services (HHS) authorized waivers under Section 1135 of the Social Security Act to relax certain administrative rules to ease burdens on Medicare providers and suppliers to more easily provide care during the COVID-19 pandemic. The “1135 blanket waivers” include, among other things, waiving the enrollment fee for Medicare B Providers for those pharmacies that want to provide COVID-19 testing and the requirement to obtain patient signatures for proof of delivery for DME Supplies such as diabetic test strips. These waivers are retroactive to March 1, 2020 and are effective until the end of the emergency declaration.
On April 6, 2020, CMS issued Interim Final Rules with Comment (CMS-1744-IFC & CMS-5531-IFC) and the DME Medicare Administrative Contractors (MACs) issued bulletins in late May explaining that suppliers must include a “CR” modifier and include a narrative of “COVID-19” for claims where patient signatures were not obtained as proof of delivery. Claims that do not include the modifier and narrative may be subject to denial.
Here is an excerpt from the DME MAC joint bulletin:
‘Suppliers should continue to use the appropriate modifiers, including the KX modifier where applicable, for all HCPCS codes included in the NCDs and LCDs listed above. In addition, the CR modifier (CATASTROPHE/DISASTER RELATED) should be added to the HCPCS code(s) billed. Finally, suppliers are instructed to enter “COVID-19” in the NTE 2400 (line note) or NTE 2300 (claim note) segments of the American National Standard Institute (ANSI X12) format or field 390-BM of the National Council for Prescription Drug Program (NCPDP) format. These abbreviations may also be used in Item 19 of the CMS-1500 claim form.’
If your pharmacy dispensed DMEPOS items and did not obtain a patient signature as proof of delivery on or after March 1, 2020, then you must include
If you have already dispensed claims without this CR modifier and COVID-19 narrative, then you should file a reopening with the DME MAC to ensure that these claims are not subject to audit recoupments in the future. If you are unable to file a reopening and subsequently have claim denials during an audit, you will still have the full appeal process available.
PAAS has reached out to both DME MACs and they have confirmed that pharmacies should submit reopenings to adjust the necessary claims to include both the CR modifier and a narrative stating “COVID-19”.
PAAS Tips:
Smartphones Put Pharmacies at Risk for Inappropriate PHI Disclosures
PAAS National®’s Fraud, Waste, and Abuse and HIPAA compliance program updates for 2020 included a new section: 11.11.5 Audio, Video, and Social Media (see our February article FWA/HIPAA Compliance Program Changes for 2020). Smartphone utilization has, unfortunately, become pervasive with patient interactions. Patients on their phone while trying to consult on new medications, or a patient snapchatting a friend while waiting for their prescription to be filled is all too common.
Pharmacies need to developJoin today!
- Confirm your HIPAA compliance program is staying relevant
- Ensure employees are adequately trained on HIPAA to mitigate risk (see our eNewsline for an OCR fine that cost a provider $10,000)
- Compliance programs offered through an entity affiliation may not be the best choice to protect your pharmacy.
and enforce a policy to mitigate inappropriate protected health information (PHI) disclosure risk given the tendency for patients to have their phone accessible at the pharmacy counter and in the patient waiting area. It is the pharmacy’s responsibility to safeguard the PHI of patients, which can include audio/video recordings by someone other than the patient. Staff awareness and training become a critical component to enforcing these policies and handling them with tact.
Discovering a PHI breach occurred through an audio/video recording needs to be documented appropriately and handled swiftly. A patient, or customer, who obtains another patient’s PHI through inappropriate methods [in the pharmacy] should be banned from the pharmacy and, if PHI was posted on social media, requested to remove the offending content. Should they refuse or fail to act promptly, reaching out to the social media platform to request removal of the offending breach would be prudent. These efforts need to be documented thoroughly in an incident report.
See the full list of 2020 FWA/HIPAA changes with additional updates on the PAAS Portal. PAAS works tirelessly to keep you one step ahead of the game and in compliance.
PAAS Tips:
PAAS Audit Assistance members can view the full article on our eNewsline.
COVID-19 Audit Considerations Follow-Up
On April 3, 2020, PAAS National® sent an urgent email alert to all members discussing COVID-19 audit considerations. This email came as a result of our desire to help pharmacies on the frontlines of this pandemic.
If you did not receive our email, please see the COVID-19 Audit Considerations memo for useful audit tips and guidance to avoid pitfalls. Emails were sent to the email addresses we have on file for your pharmacy and primary contact person. If your pharmacy missed the communication, please call or email us to update your account.
PAAS wants you to stay informed of PBM requirements to help keep your staff, patients, and business safe. Since mid-March, we have been advocating for and tracking reductions, and outright waivers, of specific PBM requirements, most notably:
The pandemic is extremely fluid, with changing dynamics and daily updates from PBMs. We have analyzed over 40 PBM communications in the last couple of weeks (just looking at national plans), and it’s vital that pharmacies be vigilant on the fine print.
PBMs will continue to use any technical discrepancy to deny claims on an audit, and these temporary waivers only increase the likelihood that pharmacies will face recoupments. PBMs will be auditing this time period, specifically looking to recoup high dollar claims without supporting documentation – in FULL.
Be careful of waiver/concession expiration dates – there will be no leeway when it comes to auditing these claims after the fact. Pay close attention to PBM communications and save our summary chart link of current concessions; you’ll want to keep a close eye on changes.
Caremark Enforcement: Aberrant Quantities & Volumes
PAAS is starting to see Caremark enforce their new policy about Aberrant Quantities and Volume that we first wrote about in a December 2019 article Important: Caremark Provider Manual Updates for 2020!. These notifications state that pharmacies have breached the Provider Agreement and the pharmacy is receiving a formal breach notice as a warning.Join today!
- The Aberrant Drug List was updated March 6, 2020
- Current list is available on Caremark’s Pharmacy Portal at https://rxservices.cvscaremark.com
Caremark updated the Provider Agreement in November 2019 (effective January 1, 2020) to require pharmacies to dispense less than 25% of claims (by claim count or dollar amount) of select medications they consider to be at high risk for Fraud, Waste or Abuse. Exceeding this 25% threshold is deemed “aberrant” dispensing. Caremark states they will monitor pharmacies on a monthly basis and if you violate the 25% threshold after receiving a breach notice, you will be subject to claim recoupment and/or network termination.
While The Aberrant Drug List is unique to Caremark, all PBMs are auditing for these types of medications. PAAS has seen numerous examples of pharmacies losing claims during audits for soliciting prescriptions of these “special” dosage strengths. We advise pharmacies to be extremely cautious about this type of dispensing as it echoes the issue of repacking NDCs at inflated AWPs from the mid-2000s.
PAAS Tips: