Example #1 – The pharmacy receives a script for Lantus Solostar® (DAW 1) from the prescriber.
Since the script was flagged “Dispense as written” by the prescriber, the pharmacy must dispense the prescribed reference product, Lantus Solostar® and should utilized DAW 1 in field 408-D8 on the claim.
Example #2 – The pharmacy received a script for Lantus Solostar® (DAW 0) from the prescriber.
Since Lantus Solostar® has an authorized interchangeable biologic (Semglee®), and both Lantus Solostar® and Semglee® have interchangeable unbranded biologics there are some additional considerations that must be made before determining the proper item to bill:
(1) State regulations regarding the substitution of interchangeable biologic agents. Many states require the least expensive biologic agent to be dispensed. To find a link to your applicable state regulation, you may reference the Cardinal Health website. This may mean looking at your inventory to see what you have in stock and trying to bill the least expensive product first, then following the PBM claim messaging if the claim rejects.
a. If the interchangeable biosimilar is dispensed instead of the reference product, DAW 0 is appropriate.
b. If the reference product is dispensed, due to a formulary preference, DAW 9 would be appropriate.
(2) Patient Preference. Though the prescriber allows for substitution, the patient may prefer to stay with the reference product prescribed, in this case that would be Lantus Solostar®. DAW 2 would be appropriate for this claim.
Example #3 – The pharmacy received a script for Semglee®, the interchangeable biosimilar for Lantus Solostar®, (DAW 1) from the prescriber.
Since the script was flagged “Dispense as Written” by the prescriber, the pharmacy must bill Semglee® as prescribed and a DAW 1 would be appropriate on this claim.
Example #4 – The pharmacy received a script for Semglee®, the interchangeable biosimilar for Lantus Solostar®, (DAW 0) from the prescriber.
If the claim is billed for Semglee®, DAW 0 would be appropriate. If instead the patient wishes to be on (or stay on) Lantus Solostar®, then DAW 2 should be used on the claim for Lantus Solostar®. If Semglee® is not available from your supplier and Lantus Solostar® is available, DAW 8 could be utilized when billing the claim for Lantus Solostar® to signify that the interchangeable biosimilar was unavailable from your wholesaler—for this scenario, be sure to keep record to prove Semglee® was unavailable in the event the claim is audited. This could be a copy of an invoice showing Semglee® was out of stock, or a screen shot of your wholesaler’s website showing it was unavailable.
Example #5 – The pharmacy received a script for insulin glargine 100 units/mL (DAW 0) from the prescriber.
Insulin glargine encompasses several different insulin products, include reference products Lantus Solostar® and its unbranded equivalent, Semglee® and its unbranded equivalent, Basaglar®, and RezvoglarTM. Pharmacy staff should consider clinical context, patient history, formulary preference, and cost of the medication when determining the correct product to bill and may need to contact the prescriber’s office for additional clarification. If Lantus Solostar® (the reference product) is billed due to formulary preference, a DAW 9 would be appropriate and if Lantus Solostar® was billed due to the patient requesting brand, DAW 2 would be appropriate. If an interchangeable biosimilar was billed, DAW 0 would be appropriate.
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DMEPOS Mini-Series #5 – Surgical Dressings
Per CMS, for the 2020 reporting period, the improper payment rate for surgical dressings was 67.3% representing $194.9 million. CMS indicated 82.4% of improper payments were due to insufficient documentation. Additional errors were no documentation (1.9%), medical necessity (1.7%), incorrect coding (1.9%) and other (12.2%). Pharmacies need to ensure that the clinical information in the patient’s records proves the dressings are reasonable and necessary as well as what type and quantity of dressing(s) they qualified for. Use the helpful tips and links below to be prepared in case of an audit on surgical dressings.
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- Required Documentation for all DMEPOS items, see our April 2021 Newsline for more details
- Standard Written Order (SWO)
- Proof of refill request
- Proof of delivery
- Medical Records
- Coverage Criteria for Surgical Dressings
- Medical records must support the surgical dressings are required for one of the following:
- Treatment of a wound caused by, or treated by, a surgical procedure, OR used after debridement of a wound
- Initial wound evaluation must include:
- Type, location, number, and size of qualifying wounds (L x W and depth)
- Amount of drainage
- Frequency of dressing change
- Ongoing wound evaluation (weekly or monthly)
- Specific dressing coverage criteria (in addition to meeting the criteria for qualifying wound)
- A new order is needed at least every 3 months for each qualified dressing dispensed, OR sooner if quantity required increases
- Modifiers (A1-A9) to indicate the number of wounds on which the dressing is being applied
- If using A9, must also submit actual number of wounds being treated in narrative on electronic claim
- Please reference the following helpful links for more detail when billing for surgical dressings:
- Surgical Dressings Local Coverage Determination (LCD)
- Surgical Dressings Policy Article
- Documentation Checklist for Surgical Dressings
- Surgical Dressings FAQs
Trudhesa™ Nasal Spray for the Treatment of Migraines
Migraine relief medications are frequently monitored and flagged for audit due to high cost, quantities submitted, days’ supply and/or frequency of refills. Trudhesa™ 4 mg/mL nasal spray was FDA approved on September 3, 2021. It is indicated for the acute treatment of migraine with or without aura in adults. While Migranal® and Trudhesa™ are both nasal sprays containing dihydroergotamine, Trudhesa™ is the newer form made to reach the bloodstream more quickly by being absorbed better through the nose. Pharmacies often struggle on billing Trudhesa™, due to some specific dosing and administration guidelines. Please see below for guidance on how to properly bill for this migraine relief medication.
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- Trudhesa™ is for nasal administration only
- Supplied as a package of four single-dose units (NDC# 77530-0725-04)
- Each single-dose unit contains a 1 mL vial and an intranasal delivery device
- Each device must be assembled and primed with exactly four sprays prior to use
- The purpose of priming is to bring the medicine to the tip of the spray nozzle. You may or may not see liquid or spray come out of the nozzle during each priming pump
- Each 1 mL vial contains 2 sprays (one dose) after the four priming sprays
- NCPDP billing unit is mL – one package containing the four units is billed as 4 mL
- There are a total of 4 doses or 8 sprays in each 4 x 1 mL package
- A complete dose is 2 sprays, 1 spray in each nostril
- If prescribed, the dose can be repeated at least one hour after the first dose
- If an additional dose is needed, a new unit must be opened and prepared
- Use or discard within 8 hours after vial has been opened or product has been assembled
- Do not use more than two doses of Trudhesa™ within 24 hours or three doses within 7 days
- If written for more than one package of 4 mL, it is best to have a notation from the physician as to the number of headaches the patient has per week or month to support billing multiple packages
- See our updated Nasal Spray Chart on the PAAS Member portal for additional guidance on billing
- See the December 2021 Newsline article, Self-Audit Series #11 – Migraine Prescriptions for further reference
- Call PAAS (608) 873-1342 with questions on how to bill Trudhesa™
NCPDP Updates DAW Code Definitions to Encompass Interchangeable Biosimilars
In the August 2022 version of the National Council for Prescription Drug Programs (NCPDP) Telecommunication Version D and Above Questions, Answers and Editorial Updates, there is new guidance in section 3.1.3 regarding interchangeable biosimilar products and Dispense As Written (DAW)/Product Selection Code (408-D8) field in anticipation of the DAW code definition updates which should go into effect October 15, 2023. With more interchangeable biosimilar products set to hit the market later this year, it is important to understand how to appropriately use these DAW codes to prevent future audit issues.
Section 3.1.3 of the NCPDP document starts by outlining the FDA definitions of a biosimilar product, interchangeable product, and reference product. It goes on to state that when a prescriber indicates DAW 1 on a prescription, substitution of the product as written is not appropriate and when the prescriber does not indicate DAW 1 on a script, DAW 0 or DAW 2-9 could be appropriate. The chart below was included in the NCPDP document to aid pharmacies in determining appropriate DAW codes to bill.
Substitution Not Allowed
While this chart is useful, you may be asking yourself – What does this all mean?! Let us go through several examples.Join today!
- See PAAS’ on-demand webinar: Understanding Interchangeability with Prescription Biologics (recorded 8/17/22)
- Remember to have visible documentation for all claims billed with a DAW code other than zero to support the use of the medication dispensed and DAW code utilized on the claim
- Refer to the “interchangeable” column on the Insulin Medication Chart and the Biologic Injectable Medication Chart located on the PAAS Member Portal, to find FDA-approved interchangeable biologic agents
- Utilize the FDA Purple Book – a searchable, online database of biologic products (remember to look for matching card colors which signify interchangeability)
Example #1 – The pharmacy receives a script for Lantus Solostar® (DAW 1) from the prescriber.
Since the script was flagged “Dispense as written” by the prescriber, the pharmacy must dispense the prescribed reference product, Lantus Solostar® and should utilized DAW 1 in field 408-D8 on the claim.
Example #2 – The pharmacy received a script for Lantus Solostar® (DAW 0) from the prescriber.
Since Lantus Solostar® has an authorized interchangeable biologic (Semglee®), and both Lantus Solostar® and Semglee® have interchangeable unbranded biologics there are some additional considerations that must be made before determining the proper item to bill:
(1) State regulations regarding the substitution of interchangeable biologic agents. Many states require the least expensive biologic agent to be dispensed. To find a link to your applicable state regulation, you may reference the Cardinal Health website. This may mean looking at your inventory to see what you have in stock and trying to bill the least expensive product first, then following the PBM claim messaging if the claim rejects.
a. If the interchangeable biosimilar is dispensed instead of the reference product, DAW 0 is appropriate.
b. If the reference product is dispensed, due to a formulary preference, DAW 9 would be appropriate.
(2) Patient Preference. Though the prescriber allows for substitution, the patient may prefer to stay with the reference product prescribed, in this case that would be Lantus Solostar®. DAW 2 would be appropriate for this claim.
Example #3 – The pharmacy received a script for Semglee®, the interchangeable biosimilar for Lantus Solostar®, (DAW 1) from the prescriber.
Since the script was flagged “Dispense as Written” by the prescriber, the pharmacy must bill Semglee® as prescribed and a DAW 1 would be appropriate on this claim.
Example #4 – The pharmacy received a script for Semglee®, the interchangeable biosimilar for Lantus Solostar®, (DAW 0) from the prescriber.
If the claim is billed for Semglee®, DAW 0 would be appropriate. If instead the patient wishes to be on (or stay on) Lantus Solostar®, then DAW 2 should be used on the claim for Lantus Solostar®. If Semglee® is not available from your supplier and Lantus Solostar® is available, DAW 8 could be utilized when billing the claim for Lantus Solostar® to signify that the interchangeable biosimilar was unavailable from your wholesaler—for this scenario, be sure to keep record to prove Semglee® was unavailable in the event the claim is audited. This could be a copy of an invoice showing Semglee® was out of stock, or a screen shot of your wholesaler’s website showing it was unavailable.
Example #5 – The pharmacy received a script for insulin glargine 100 units/mL (DAW 0) from the prescriber.
Insulin glargine encompasses several different insulin products, include reference products Lantus Solostar® and its unbranded equivalent, Semglee® and its unbranded equivalent, Basaglar®, and RezvoglarTM. Pharmacy staff should consider clinical context, patient history, formulary preference, and cost of the medication when determining the correct product to bill and may need to contact the prescriber’s office for additional clarification. If Lantus Solostar® (the reference product) is billed due to formulary preference, a DAW 9 would be appropriate and if Lantus Solostar® was billed due to the patient requesting brand, DAW 2 would be appropriate. If an interchangeable biosimilar was billed, DAW 0 would be appropriate.
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Medicare Part D Long-Term Institutionalized (LTI) Resident Report
PAAS National® recently assisted numerous pharmacies that received an email communication from Express Scripts stating the pharmacy had inappropriately billed Part D claims while patients were in a qualified Part A stay. The communication cited CMS’s LTI Resident Report as the reason for the conclusion of erroneous payments.
Many pharmacies reported that the data did not seem to add up as prescriptions were dispensed to either retail patients or patients that were residing in nursing homes while on “private pay” and not on a Part A stay. PAAS helped pharmacies get in touch with the appropriate CMS regional office, Part D Plan Sponsor, and an Express Scripts audit manager to challenge the findings. Within a few days Express Scripts sent additional emails to affected pharmacies notifying them that the first email was sent in error.
Background on CMS LTI Resident Report
Every calendar quarter CMS provides a list of Medicare patients that have been enrolled in a Part A skilled nursing facility stay to Part D Sponsors. This list identifies the skilled nursing facilities where the beneficiaries resided, so that Sponsors (and their PBMs) can ensure network pharmacies are available to serve these beneficiaries.
Part D Sponsors can also use this list to prevent inappropriate Part D payment of drugs covered by Medicare Part A. Sponsors, and their PBMs, can implement prospective edits to reject Part D claims at point of sale when a beneficiary is enrolled in a Part A stay, and these can be used for retrospective reviews of paid claims to identify prescriptions that should have been billed under Part A.
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- Review your procedures to communicate with skilled nursing facilities when patients are admitted, discharged, or moved to/from Part A to “Private Pay” status, to guarantee that pharmacies are billing the correct party.
- Develop agreements to bill skilled nursing facilities when claims “should have been” billed to Part A but were incorrectly billed to Part D. Payment errors are bound to happen eventually, and if pharmacies and facilities have not discussed how to handle in advance, it could be more difficult to reconcile payments later.
Automatic Mailing for Part D Patients
As a follow up to the August 2022 Newsline article, Medication Synchronization: Possible Concerns we want to remind pharmacies of some specific requirements when automatically mailing refills to Medicare Part D patients. CMS first outlined requirements for auto-shipping refills in the 2014 Call Letter and most recently made revisions in the 2020 Call Letter – these requirements were implemented in response to beneficiary complaints of receiving medications that they did not order or want and to reduce waste and unnecessary cost to both patients and taxpayers.
Here are the important points from the 2020 Call Letter:Join today!
- Automatic shipping of refills must be voluntary
- Affirmative consent is NOT required prior to shipping each refill if the pharmacy provides the following protections
- Enrollment in auto-shipping is done on a drug-by-drug basis after an initial fill
- Patients may opt-out at any time
- Pharmacy provides a minimum of two shipping reminders before each fill
- Reminders should include the name of the medication, approximate ship date, information to determine the cost-share amount and how to cancel
- Pharmacy must provide a refund for any unwanted fills
- This must occur even if the patient does not return the medication to the pharmacy
- The Call Letter requirements only apply to Medicare Part D prescriptions that are automatically shipped and do not apply to med sync prescriptions that are picked up at the pharmacy
- Caremark and Express Scripts Provider Manuals mirror the 2020 Call Letter guidance for Medicare Part D
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Navigating Rights & Responsibilities in a Post-Roe v. Wade World
With the overturning of Roe v. Wade, the U.S. Supreme Court ruling on an individual’s rights surrounding abortion, pharmacies may be left wondering how to proceed. Being aware of legislation that exists is a pertinent first step in guiding your pharmacy practice.
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a statement which first acknowledges pharmacies’ importance to the healthcare system, in part due to the accessibility to patients. As such, the statement attempts to reinform retail pharmacies of their obligation to ensure patient access to comprehensive reproductive health care without discrimination, which includes potential, current, or past pregnancy, or medical conditions related to pregnancy or childbirth. The guidance reminds pharmacies that under Section 1557 of the Affordable Care Act and Section 504 of the Rehabilitation Act of 1973, entities that accept federal funding cannot discriminate when dispensing medications, determining medication appropriateness, and/or advising patients about medication usage. In addition to the guidance given, HHS OCR also brings attention to the high, yet preventable, maternal mortality rate in the United States and reaffirmed their dedication to improving maternal health via “vigorous enforcement of our civil right laws”.
Frustratingly, this guidance puts pharmacists between states that have moved to limit abortions and the federal government – who seems committed to protecting access, despite the Supreme Court ruling.
In tandem with the above-mentioned civil rights that patients possess, healthcare entity employees also possess civil rights that OCR enforces. The Church Amendments (42 U.S.C. §300a-7) protects health care employees’ personal beliefs from being a point of discrimination in relation to employment. For example, actions taken by a health care employee cannot be discriminated against if due to their “religious beliefs or moral convictions”. That said, OCR reserves the right to assess and apply the Church Amendments on a case-by-case basis. To learn more, reference HHS’s Guidance on Nondiscrimination Protections under the Church Amendment.
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- Be knowledgeable on what state laws are in effect considering Roe v. Wade being overturned
- Obtain an understanding on exceptions to state regulations
- Many of the medications being called into question have various indications. As such, consider proper documentation of indication for use to mitigate risk
- Consider PAAS’ Cultural Competency Training to better serve your patient population
Be Prepared for Audits on Pharmacist-Prescribed Paxlovid
The FDA released a statement on July 6, 2022, which expanded the Emergency Use Authorization (EUA) of PaxlovidTM (nirmatrelvir and ritonavir) “to authorize state-licensed pharmacists to prescribe PaxlovidTM to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of PaxlovidTM.” As pharmacies across the country are gaining access to this anti-viral COVID-19 therapeutic agent, it is important to understand the specifications of the EUA and verify your pharmacy has a process in place to capture and maintain documentation supporting the validity of the claim, in the event these claims are audited. Think to yourself, would an auditor have irrefutable evidence that this patient qualified for treatment and that the pharmacist-prescribed PaxlovidTM was provided pursuant to EUA guidelines?Join today!
Patient Qualifications
EUA Limitations for Pharmacists to Prescribe PaxlovidTM
Additional Documentation to Maintain
Must meet ALL:
Must meet ALL:
PAAS National® analysts suggest ALL of the following:
- Limitations on authorized use of PaxlovidTM:
- Not authorized for the treatment of patients requiring hospitalization due to severe COVID-19
- Not authorized for pre-exposure or post-exposure prophylaxis to prevent COVID-19
- Not authorized for use longer than five consecutive days
- Kidney and liver function, as well as the patient’s current list of medications, must be assessed to determine if PaxlovidTM is an appropriate therapy for the patient and if the dose needs to be reduced
- For additional details refer to the:
- July 6, 2022, Emergency Use Authorization for Paxlovid
- Fact Sheet for Healthcare Providers: EUA for PaxlovidTM
- Fact Sheet for Patients, Parents, and Caregivers: EUA of PAXLOVIDTM for COVID-19
- List of medical conditions and factors associated with increased risk for progression to severe COVID-19 as per the CDC
· ≥ 12 years old
· ≥ 88 pounds (40 kg)
· Positive SARS-CoV-2 viral testing
· Symptom onset was within ≤ 5 days
· Mild-to-moderate coronavirus disease
· At high risk for progression to severe COVID-19, including hospitalization or death
· Sufficient medical records < 12 months old or consultation with health care provider to assess renal (kidney) function
· Sufficient medical records < 12 months old or consultation with health care provider to assess hepatic (liver) function
· Sufficient information is available (via access to health records, patient reporting of medical history, or consultation with health care provider) to obtain a medication list to check for potential drug interactions
· Patient-specific placeholder hardcopy referencing the pharmacist’s authority to prescribe (e.g., EUA and PREP Act, standing order, or collaborative agreement, etc.) and details of the prescription
· Proof patient met all qualifications
· Proof pharmacist verified kidney function, liver function, and had sufficient information to assess potential drug interactions
· Vaccine administration record
· Date/version of the Fact Sheet for Patients, Parents, and Caregivers EUA of PaxlovidTM for COVID-19 that was given
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Be Audit Ready! Clinical Notes and Annotations: What Documentation is Essential for Audit?
Many pharmacies receive hundreds of prescriptions every day, and inevitably, some of those prescriptions will contain errors, omissions, or just be confusing enough to require clarification with the prescriber’s office. When these situations occur, make sure you have good documentation of the conversation with the prescriber’s office to successfully pass an audit that may occur years later.
Documentation that should be included in any clinical note are as follows:
This documentation should either be noted directly on the prescription or within your dispensing software. For clinical notes on controlled substance prescriptions received electronically, the clinical note must be made and retained electronically per 21 CFR 1311.200(f). Any notations made must be visible to the auditor at the time of audit.
Clarifications to a prescription should be made prior to dispensing. PAAS National® has seen clinical notes invalidated when the pharmacy prints an image of a prescription for audit that shows the printed date, then proceeds to hand-write a clinical note on the prescription with a date prior to the printed date of that prescription. The auditor assumes the pharmacy “made up” the clinical note after the audit notice was issued and will expect the pharmacy to prove the clinical note was valid on appeal.
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A Day in the Life of a PAAS National Analyst – Audits, Billing Questions and FWA/HIPAA support
With over 200 years of combined pharmacy experience and over 50 years of dedicated audit assistance experience, this PAAS National® analyst team is the best in the industry.
The PAAS Analyst team is made up of five pharmacists and three certified pharmacy technicians. Their job day in and day out is to be a member’s resource in:
Answering filling and billing questions
PAAS provides proactive education – a guiding light steering community pharmacies from trouble. Keep in mind the prescription claims you submit today may be the subject of an audit conducted a year or two from now. Audit-proof your pharmacy today, bill it correctly, and avoid future recoupments. PAAS can provide information on new wrinkles and requirements to safely bill a prescription.
FWA/HIPAA compliance guidance
PAAS Fraud, Waste & Abuse and HIPAA Compliance program members can get guidance to help avoid being caught off guard. Having a HIPAA expert on your side to navigate through the turbulent waters of a data breach or internal fraud investigation can help ensure that all appropriate steps are taken, and deadlines are not missed.
Preparing you for on-site and virtual audits
If you receive notification, your first step is to get the audit notice to PAAS. Your all-inclusive membership means there are no hidden fees or limits to the number of audits we provide assistance on. After receiving your notice, a PAAS Analyst will reach out to you within 2 business days for a customized, pre-audit consultation to guide you on next steps. PAAS is here to support you! Make PAAS part of your audit process, every time.
Review your prescriptions for desk audits
When reviewing prescriptions in preparation for an audit, it is helpful to reference the self-audit tool. Every prescription has required information that needs to appear on the original hard copy. Ask a PAAS analyst for assistance with your next audit to confirm you have the required information. If you receive an audit notification, your first step is to get the audit notice to PAAS.
Work with you on your audit appeals
Our team members are highly trained experts, here to help you! Even though it is best to involve PAAS from the very beginning with audits big or small, we provide guidance regardless, and will guide you through an appeal to help give you the best chance at favorable results.
Could You Be Giving Vaginal Creams Away for Free?
PAAS National® analysts continue to see claims for Premarin® and Estrace® creams being audited and recouped. Pharmacies not calculating the accurate days’ supply are in jeopardy of refilling too soon. These early refills will be taken back during audit which means the pharmacy is basically handing the medication out for free.
Since these vaginal creams only come in one package size, instructions rarely support the days’ supply to be 30. This makes your claims easy targets if you are consistently defaulting the days’ supply. Software default fields, plan limits, or data entry errors should all be reviewed to ensure you have safeguards in place to prevent losing these claims.
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- 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
- For a pea-sized amount, work with prescribers to clarify if 0.25 grams would be appropriate (half of a finger-tip unit)
- Clarify any instructions that do not provide enough information to accurately calculate days’ supply
- See our June 2021 Newsline article, Self-Audit Series #5: Topical Prescriptions
- Always submit an accurate days’ supply first, as many plans now have overrides for exceeding plan limits
- Refer to our Can You Bill It As 30 Days? in our Tools & Aids section if plan limits are exceeded
- Self-audit your vaginal creams for accurate days’ supply and appropriate instructions
- Vaginal creams are not recommended to be part of a patient’s med sync program – refill upon request only