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    v1.0.28
    OpenPayerBilling CodesComponents, Accessories and SuppliesHCPCS hcpcs-k1035-molecular-diagnostic-self-test-reader
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    HCPCS Level II K1035: Molecular Diagnostic Test Reader, Self-Administered

    HCPCS Level II code K1035 describes an FDA-authorized molecular diagnostic test reader intended for nonprescription, self-administered and self-collected use; the service is a molecular diagnostic device reading service supporting at-home specimen collection and interpretation, with the typical site of service being patient self-collection and testing in the home or other non-clinical settings.

    For related coverage guidance, see recent payer policy updates: Interferential Stimulation Devices (for home use), Durable Medical Equipment (DME): Tumor Treating Fields (Alternating Electric Field Therapy) Medical Guideline, Durable Medical Equipment (DME): Bone Growth Stimulators Medical Guideline.

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    Table of contents

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    Clinical & Coding Specifications

    Clinical Context

    A typical patient is an adult receiving an FDA-authorized, over-the-counter molecular diagnostic test for self-collection and self-administration at home to detect a respiratory pathogen (for example, SARS-CoV-2 or influenza). The patient obtains the test from a retail pharmacy or is provided the device by a clinic. The workflow begins with the patient reviewing manufacturer instructions, performing a nasal or saliva self-collection, running the assay in the approved reader device, and receiving an on-device result. The patient may report results to their primary care clinician or an occupational health office for return-to-work decisions. If a positive result is obtained, the clinician documents the result in the medical record and may order confirmatory laboratory-based molecular testing or initiate clinical management and isolation guidance. Typical sites of service include home/self-care, retail pharmacy, and occasionally outpatient primary care or urgent care when device demonstration or supervised self-collection is required.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    87428Infectious agent antigen detection by immunoassay technique, multiple-step method; SARS-CoV-2 (Coronavirus), amplified probe techniqueMay be used for laboratory-based molecular amplification testing when a confirmatory test is ordered after a positive home molecular reader result.
    87635Infectious agent detection by nucleic acid (DNA or RNA); SARS-CoV-2, amplified probe techniqueCommonly used for high-complexity PCR confirmation of positive or indeterminate results from a self-administered molecular reader.
    87804Infectious agent detection by nucleic acid (DNA or RNA); multiple organisms via multiplex amplified probe techniqueUsed when a multiplex respiratory pathogen panel is ordered following a positive or symptomatic result from the self-test.
    99000Handling and/or conveyance of specimen for transfer from physician's office to a laboratoryUsed when a specimen collected at a clinic for confirmatory testing is transported to a reference laboratory.
    99051Services provided in the evening, weekend, or holiday (surcharge)May be applied when clinician time for test counseling or result interpretation occurs outside regular office hours.

    Related Modifiers

    8 rows

    ModifierDescriptionWhen to Use
    22Modifier –22 (Increased Procedural Services) is used when a reported procedure is substantially more extensive than normally required. The CPT Manual and CMS state it may be appended only when the…- When to use: Append modifier -22 to a procedural CPT code when the service performed is substantially more extensive than the usual service described by that code — i.e., the procedure required…
    23Modifier -23 (Unusual Anesthesia) is used on anesthesia service CPT codes when a procedure that normally requires no anesthesia or only local anesthesia must be performed under general anesthesia…- Use modifier -23 only on anesthesia CPT codes (00100–01999) when a procedure that normally requires no anesthesia or only local anesthesia must be performed under general anesthesia because of…
    52Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
    53Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
    54Modifier ‑54 (“Surgical care only”) is appended to a CPT surgical procedure when the reporting surgeon performs the intraoperative (surgical) component but does not furnish the preoperative and/or…- Use modifier -54 when the reporting surgeon provided only the intraoperative (surgical) component of a procedure and preoperative and/or postoperative management has been or will be provided by…
    55Modifier –55 indicates the billing provider furnished only postoperative management for a procedure that has a global surgical period. According to AAPC, this modifier is appended to the same CPT…- Use modifier -55 when billing the same CPT surgical code that has a 10- or 90-day global period and you, as a provider other than the original surgeon, furnished ONLY postoperative management (no…
    56Modifier ‑56 indicates the reporting provider furnished only the preoperative management for a surgical procedure and did not perform the intraoperative or postoperative care. It is used in…- Use Modifier -56 when a provider performs only the preoperative management in a split‑care situation (one physician manages preop care while a different physician performs the intraoperative…
    62Modifier 62 indicates that two surgeons function as co‑surgeons, each performing distinct parts of the same primary surgical procedure. It is appended to the primary procedure code (and any…- Use modifier -62 when two surgeons act as co‑surgeons (both primary surgeons) on a single definitive primary procedure, each performing distinct parts of the same surgical procedure (append -62 to…

    Related Provider Taxonomies

    8 rows

    Taxonomy CodeSpecialtyNotes
    207Q00000XFamily Medicine PhysicianFamily Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
    207R00000XInternal Medicine PhysicianA physician who provides long-term, comprehensive care in the office and the hospital, managing both common and complex illness of adolescents, adults…
    208D00000XGeneral Practice PhysicianA physician who specializes in the general practice of diagnosing, treating, and managing patients with a variety of illnesses and conditions.
    363L00000XNurse Practitioner(1) A registered nurse provider with a graduate degree in nursing prepared for advanced practice involving independent and interdependent decision mak…
    363A00000XPhysician AssistantA physician assistant is a person who has successfully completed an accredited education program for physician assistant, is licensed by the state and…
    2278P1005XPulmonary Rehabilitation Certified Respiratory TherapistThe respiratory therapist can assist the chronic pulmonary patient in returning to an optimal role in society by providing an effective program. It i…
    2865C1500XDeactivated - Military Hospital
    335U00000XOrgan Procurement OrganizationA federally designated organization that works with hospital personnel in retrieval of organs for transplantation. The federal government designates a…

    Related ICD-10-CM Codes

    28 rows

    ICD-10-CM CodeDescription
    B34.2Coronavirus infection, unspecified
    B34.9Viral infection, unspecified
    B97.29Other coronavirus as the cause of diseases classified elsewhere
    J00Acute nasopharyngitis [common cold]
    J02.9Acute pharyngitis, unspecified
    J06.9Acute upper respiratory infection, unspecified
    J10.1Influenza due to other identified influenza virus with other respiratory manifestations
    J11.1Influenza due to unidentified influenza virus with other respiratory manifestations
    J12.9Viral pneumonia, unspecified
    J18.9Pneumonia, unspecified organism

    Showing 1–10 of 28

    Related Payer Policy Updates

    Specialty: Durable Medical Equipment (DME)1 / 2

    5 rows

    PolicyPayerEffective Date
    Interferential Stimulation Devices (for home use)Moda Health2026-10-01
    Durable Medical Equipment (DME): Tumor Treating Fields (Alternating Electric Field Therapy) Medical GuidelineWPS Health Insurance2026-10-01
    Durable Medical Equipment (DME): Bone Growth Stimulators Medical GuidelineWPS Health Insurance2026-10-01
    General Durable Medical Equipment (DME) Medical GuidelineWPS Health Insurance2026-10-01
    Prior Authorization for Durable Medical Equipment (DME)Blue Cross Blue Shield - Rhode Island2026-10-01

    Related Codes

    HCPCS-K1004-LOW-FREQUENCY-ULTRASONIC-DIATHERMY-HOME-DEVICE

    HCPCS Level II K1004: Low-Frequency Ultrasonic Diathermy for Home Use

    HCPCS-K1005-DISPOSABLE-BREAST-MILK-COLLECTION-STORAGE-BAG

    HCPCS K1005: Disposable Breast Milk Collection and Storage Bag

    HCPCS-K1006-HOME-SUCTION-PUMP-URINE-MANAGEMENT

    HCPCS Level II K1006: Home Suction Pump for External Urine Management

    HCPCS-K1007-POWERED-BILATERAL-LOWER-EXTREMITY-ORTHOSIS

    HCPCS K1007: Bilateral Powered Hip/Knee/Ankle/Foot Device

    HCPCS-K1009-SPEECH-VOLUME-MODULATION-SYSTEM

    HCPCS K1009: Speech Volume Modulation System

    HCPCS-K1010-INDWELLING-INTRAURETHRAL-DRAINAGE-DEVICE-REPLACEMENT

    HCPCS K1010: Indwelling Intraurethral Drainage Device with Valve, Replacement Only

    HCPCS-K1011-ACTIVATION-DEVICE-INTRAURETHRAL-DRAINAGE-VALVE-REPLACEMENT

    HCPCS K1011: Activation Device for Intraurethral Drainage Valve, Replacement Only

    HCPCS-K1012-CHARGER-BASE-INTRAURETHRAL-ACTIVATION-DEVICE-REPLACEMENT

    HCPCS Level II K1012: Charger and Base Station for Intraurethral Activation Device, Replacement Only

    HCPCS-K1013-ENEMA-TUBE-REPLACEMENT

    HCPCS Level II K1013: Enema Tube, Replacement Only

    HCPCS-K1014-ENDOSKELETAL-KNEE-SHIN-4-BAR-FLUID-CONTROL

    HCPCS K1014: Endoskeletal Knee-Shin System, Multiaxial, Fluid Swing/Stance Control

    Showing 1–10 of 32

    Frequently Asked Questions

    References

    1. 1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
    2. 2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
    3. 3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.
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