K1035 — Molecular diagnostic test reader, nonprescription self-administered and self-collected use, fda approved, authorized or cleared
K1035 is a HCPCS Level II code for molecular diagnostic test reader, nonprescription self-administered and self-collected use, fda approved, authorized or cleared. It belongs to the Durable Medical Equipment (DME MAC Temporary) section. Whether Medicare pays it depends on the coverage rule below.
Medicare coverage: Carrier judgment
Coverage is decided by your Medicare contractor, not by national policy. Whether this is paid depends on the LCD for your jurisdiction and on what the documentation supports.
From the coverage field of the CMS Alpha-Numeric HCPCS File, release 2026Q3-Jul. This states Medicare’s position on the code, not on your particular claim.
Medically Unlikely Edits — units per day
The most units of K1035 Medicare will pay on one date of service. Bill more on a single line and it is denied. The limit is not the same in every setting, so the row that matters is the one matching the claim you are building.
- practitioner
- 1 unit MAI 3 — Date of Service Edit: Clinical · Nature of Equipment
- outpatient
- 1 unit MAI 3 — Date of Service Edit: Clinical · Nature of Equipment
- DME supplier
- 1 unit MAI 3 — Date of Service Edit: Clinical · Nature of Equipment
The adjudication indicator decides whether exceeding the limit is worth appealing at all: MAI 1 is a line edit you can support with documentation, MAI 3 is a date-of-service edit that is also appealable, and MAI 2 is absolute — no documentation overrides it. CMS MUE 2026Q3.
The CMS record for K1035
- Long descriptor
- Molecular diagnostic test reader, nonprescription self-administered and self-collected use, fda approved, authorized or cleared
- Short descriptor
- Mol diag reader self-admn
- Added
- April 1, 2023
- BETOS
- Z2
- Pricing indicator
- 00 — Not priced by Part B
The official wording. This is what the code means.
CMS's 28-character form, which is what shows up on a remittance advice.
When CMS introduced the code.
Berenson-Eggers Type of Service — CMS's own analytic grouping.
Service not separately priced by Part B — not covered, bundled into another service, or used by Part A only.
Codes adjacent to K1035
HCPCS has no hierarchy — related items simply sit next to each other in the numbering. If K1035 is not quite right, the correct code is very often within a few positions of it.
- K1027Oral device/appliance used to reduce upper airway collapsibility, without fixed mechanical hinge, custom fabricated, includes fitting and adjustment
- K1028Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by phone applicationterminated
- K1029Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by phone application, 90-day supplyterminated
- K1030External recharging system for battery (internal) for use with implanted cardiac contractility modulation generator, replacement only
- K1031Non-pneumatic compression controller without calibrated gradient pressureterminated
- K1032Non-pneumatic sequential compression garment, full legterminated
- K1033Non-pneumatic sequential compression garment, half legterminated
- K1034Provision of covid-19 test, nonprescription self-administered and self-collected use, fda approved, authorized or cleared, one test count
- K1036Supplies and accessories (e.g., transducer) for low frequency ultrasonic diathermy treatment device, per month
- K1037Docking station for use with oral device/appliance used to reduce upper airway collapsibility
- L0112Cranial cervical orthosis, congenital torticollis type, with or without soft interface material, adjustable range of motion joint, custom fabricated
- L0113Cranial cervical orthosis, torticollis type, with or without joint, with or without soft interface material, prefabricated, includes fitting and adjustment
- L0120Cervical, flexible, non-adjustable, prefabricated, off-the-shelf (foam collar)
- L0130Cervical, flexible, thermoplastic collar, molded to patient
- L0140Cervical, semi-rigid, adjustable (plastic collar)
- L0150Cervical, semi-rigid, adjustable molded chin cup (plastic collar with mandibular/occipital piece)
Questions about K1035
What is HCPCS code K1035?
K1035 is a HCPCS Level II code for molecular diagnostic test reader, nonprescription self-administered and self-collected use, fda approved, authorized or cleared. It sits in the Durable Medical Equipment (DME MAC Temporary) section.
Does Medicare cover K1035?
The CMS HCPCS file marks K1035 as "Carrier judgment". Coverage is decided by your Medicare contractor, not by national policy. Whether this is paid depends on the LCD for your jurisdiction and on what the documentation supports.