stay informed about these changes. CMS released two helpful guidance documents: the PrEP for HIV National Coverage Determination (NCD) Technical Frequently Asked Questions for Pharmacies and the Fact Sheet: Medicare Part B Coverage of Pre-exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention. Below is a summary of the guidance provided in these two CMS documents.

First, the pharmacy must be enrolled as a Part B pharmacy supplier or as a DMEPOS supplier to bill Medicare Part B for HIV PrEP medications. If your pharmacy is not currently enrolled as a supplier, but you wish to take the steps to become enrolled, CMS recommends enrolling as a Part B pharmacy supplier since there is a “lower burden of enrollment” and revalidation does not occur as frequently for a Part B pharmacy supplier compared to a DMEPOS supplier. More information about enrollment can be found by going to the PrEP for HIV & Related Preventative Services CMS webpage and clicking on “How Do I Enroll”.

Second, pharmacies must submit a valid diagnosis code (ICD-10) on the HIV PrEP claim. Below is a table of diagnosis codes that may be appropriate.

Diagnosis Code Description	Diagnosis Code
Encounter for HIV PrEP	Z29.81
Encounter for screening for HIV	Z11.4
Increased risk factors reported	Z11.4, Z29.81, Z20.6, Z20.2, Z11.3 (plus many more)

Third, the following are expectations of the dispensing pharmacy:

1. Have and maintain the order from the ordering physician or non-physician practitioner.
2. Obtain the diagnosis code from the ordering practitioner.
3. Have and maintain proof of delivery (i.e., a signed receipt or some other indication the item was dispensed to the beneficiary).
4. The date the claim is billed should match the date of dispensing, defined as the date the drug is picked up from the pharmacy or date drug is mailed.
5. Bill either a 30, 60, or 90 days’ supply and bill the appropriate corresponding HCPCS code.
6. No modifiers are required on the HIV PrEP claims (see PAAS Tips for 340B claims).

HIV PrEP Medication (Billed on Drug Fee Claim)				Pharmacy Supply “Dispensing” Fee
HCPCS Code	Description	Proprietary Name		HCPCS Code	Description
J0799	HIV PrEP, FDA approved
J0750	Emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (oral)   Or, “HIV prep ftc/tdf 200/300 mg”	Truvada®		Q0516     Q0517     Q0518	Oral drug, per 30-days     Oral drug, per 60-days     Oral drug, per 90-days
J0751	Emtricitabine 200 mg + tenofovir alafenamide 25 mg (oral)   Or, “HIV prep, ftc/taf 200/25 mg”	Descovy®
J0739	Cabotegravir 1 mg injection   Or, “Injection, cabotegravir, 1 mg”	Apretude		Q0519   Q0520	Injectable drug, per 30-days   Injectable drug, per 60-days

Fourth, “the supply fee must be billed on the same claim as the PrEP for HIV drug”. This means, the pharmacy will bill the drug fee as well as the supply (“dispensing”) fee; both claims should be billed with the same date of service, diagnosis code, place of service, etcetera. If your pharmacy utilizes a Medicare Part B billing intermediary, the dispensing fee claim will likely be taken care of by the intermediary on behalf of the pharmacy. If the PrEP drug (e.g., cabotegravir) is being delivered to a medical practice for administration, the date of service billed should match the date of service delivered to the medical office. The medical office would then bill Medicare separately for the administration fee once they administer the medication to the patient. The date of service on the administration fee claim from the medical practice does not have to match the date of service on the pharmacy’s drug and supply fee claims.

Fifth, Medicare Part B claims must be submitted with the name and NPI number of the enrolled ordering/referring practitioner and the name and NPI of that practitioner must appear in the CMS Order and Referring dataset. Since pharmacists do not currently appear in this dataset, they are not eligible for ordering PrEP drugs for payment under Medicare Part B. Therefore, “if a pharmacist, under state scope of practice laws, furnishes counseling, injects a PrEP drug or orders PrEP, those series cannot be paid directly to the pharmacy and the drugs cannot be paid by Medicare Part B. Pharmacists may provide, when all conditions are met, service as auxiliary personnel “incident to” a physician’s or other practitioner’s service in certain settings. The incident to regulations require supervision by a physician or other practitioner, and such services would be billed by the supervising physician or practitioner.” Additional information about “incident to” services can be found under 42 CFR §§410.26 and 410.227 or visit the Incident To Services & Supplies CMS webpage.

PAAS Tips:

• Ensure these HIV PrEP medications are returned with a $0 copay from in-network pharmacies as of September 30, 2024
• Pharmacies not enrolled as a DMEPOS supplier or Medicare Part B Pharmacy supplier can refer individuals to 1-800-MEDICARE (1-800-633-4227) and they can assist the individual with finding another pharmacy where they can receive their PrEP
  • Mail order pharmacies may be available
  • Teletypewriter (TTY) users can call 1-877-486-2048
• Pharmacies enrolled with Medicare Part B solely with a “mass immunization” provider type will need to enroll as a provider type “pharmacy” before they can bill Medicare Part B for HIV PrEP
• These same antiretroviral drugs may also be used for the treatment of HIV and (when using for treatment, not prevention) should continue to be billed to Medicare Part D
• For a patient with a Medicare Advantage plan, bill their Advantage plan (not their original Medicare Part B red/white/blue card) and watch the returned patient co-pay; if it is not $0, the pharmacy may not be contracted with the Advantage plan for medical billing (even if the pharmacy is contracted for pharmacy billing)
• PrEP claims which are 340B eligible do require a modifier on the claim, either “JG” (drug or biological acquired with 340B drug pricing discount, reported for information purposes) or “TB” (drug or biological acquired with 340B drug pricing discount, reported for information purposes for select entities); for more information on 340B modifiers, refer to the March 2023 Medicare Learning Network bullet

that the correct quantity cannot be determined without the proper UOM being present. To combat the discrepancy, pharmacies may need to obtain a letter from the prescriber to substantiate what the pharmacy billed was indeed the correct quantity. These letters are often difficult to obtain, especially when claims are several years old, prescribers have relocated, or your pharmacy doesn’t have a working relationship with the office.

If your pharmacy receives a prescription without a UOM, or a UOM that is ambiguous, PAAS recommends contacting the prescriber for clarification and documenting with a clinical note.

Examples:

1. You receive a prescription for Lantus^® Solostar^® pens, quantity 15, UOM “unspecified.”
   1. Did the prescriber intend for the prescription to be written as 15 mL, 15 pens, or 15 boxes?
2. You receive a prescription for Combigan^® solution, quantity 1, UOM “bottle.”
   1. Did the prescriber intend for the 5 mL, 10 mL, or 15 mL bottle?
3. You receive a prescription for Trelegy Ellipta, quantity 1, UOM “inhaler.”
   1. At first glance, this may seem like an acceptable prescription. However, Trelegy comes in two sizes. Did the prescriber intend for the 60 each retail package or the 28 each institutional size package? “Each” is the proper UOM per NCPDP guidelines.
4. You receive a prescription for Trelegy Ellipta, quantity 1, UOM “each.”
   1. The correct billing unit is “each,” but the quantity should either be 60 for the retail package or 28 for the institutional package. Third party auditors will often flag the “1 each” combination – contact the prescriber to avoid ambiguity.

The following table shows the medications PAAS typically sees UOM troubles with and the typical billing units that should be used:

Drug Type	Correct Billing Unit	UOM Needing Clarification
Eye Drops	mL, each*	bottle
Injectables	mL, each*	kit
Nasal Inhalers	mL, gm, each*	inhaler
Oral Inhalers	gm, each*	inhaler
Insulin	mL	each
Topicals	mL, gm	tube

*The “each” UOM may need to be clarified if the quantity doesn’t correspond to an “each” unit of measure (e.g., 10 each on an eye drop likely indicates 10 mL vs 10 bottles of 10 mL)

When in doubt, clarify the prescription. Do not leave the UOM interpretation to a third-party auditor who has no reason to give you the benefit of the doubt and every reason to interpret it to their advantage.

PAAS Tips:

• Ambiguous or missing UOM should be clarified with the prescriber with a clinical note added to the prescription before dispensing
• The best quantity clarification will contain the actual billing unit per NCPDP for the drug, leaving no room for misinterpretation
• Clinical notes should contain the date, name and title of who you spoke with, summary of discussion, and your initials
• Pay close attention to electronic prescription quantities which have the biggest potential for incorrect or “unspecified” UOM
• Other prescription origins (written, fax, and transfer) may need clarification for missing UOM
• Notating UOM on all telephone orders would be considered best practice
• Some PBMs may consider a quantity of “1” to be the smallest package size; therefore, clarify the quantity with the prescriber if dispensing a larger size

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. Some PBMs have started to use this data for reimbursement formulas on commercial and Medicare Part D claims as well (e.g., Capital Rx).

CMS has contracted with Myers & Stauffer, LC (a professional accounting firm) to conduct these retail pricing surveys. Outpatient 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. However, this may change with a newly introduced bill, Drug Pricing Transparency in Medicaid Act of 2023 (H.R. 1613). If passed, this bill would make the surveys mandatory for pharmacies and simultaneously include updates to ban spread pricing in State Medicaid Plans. NCPA has a summary “one-pager” on H.R. 1613 that pharmacies can share with their legislators here.

PAAS Tips:

• 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 the NADAC helpdesk, operated by Myers and Stauffer, at (855) 457-5264 or survey@mslcrps.com if you have additional questions about the survey