Business of Audiology

Protocol Variations

  • Real Ear Protocols theme: personal preference in choosing how to implement targets and adjustments.

  • Protocol Variation 2: Test signal intensity variations

    • Soft input: 50-55dB

    • Moderate input: 60-65dB

    • Loud input:75-80dB

    • Start with soft input; band adjustments before channel adjustments recommended; some clinicians use targets at 50, 65, 80dB targets depend on chosen input levels.

  • Protocol Variation: Increased Efficiency

    • Step 1: Present a 55dB SpeechMap signal; adjust soft channel until LTASS matches prescriptive targets (DSL, NAL-NL2, Audibility targets).

    • Step 2: Present a 75dB SpeechMap signal; adjust loud channel until LTASS matches prescriptive targets.

    • Step 3: Present a65dB SpeechMap signal; response recorded with no adjustment; based on prior adjustments, no further changes needed.

Medicare Reimbursement & Medical Necessity

  • Medicare reimbursement overview

    • Covered: diagnostic evaluations, reevaluations, assessments of medication/surgery effects, and diagnostic analysis of cochlear/brainstem implants; programming and periodic analyses after implantation are covered when medically necessary.

    • Non-covered: diagnostic or rehabilitative services performed solely to prescribe, fit, or modify prescription air-conduction hearing aids.

  • What is medical necessity?

    • Title XVIII, Sec. 1862(a)(1)(A): payment only for items/services that are reasonable and necessary for diagnosis or treatment or to improve functioning of a malformed body member.

  • What constitutes medical necessity?

    • Services not for patient/practitioner convenience.

    • Must be necessary based on diagnosis or symptoms.

    • Re-evaluation for suspected changes in hearing, tinnitus, or balance; evaluation to investigate cause of a disorder; evaluation to determine treatment effects.

    • Reevaluation to follow changes due to comorbidities that place patient at risk (examples: Menière’s disease, otosclerosis, autoimmune inner ear disease, ototoxicity, etc.).

Rules for Orders & Reimbursement

  • Physician’s order requirements

    • Generally required for audiology services in all settings.

    • Order can be written, telephone, or electronic communications from treating physician/practitioner.

    • Exception: 42 CFR 410.32(a)(4) allows once-per-12-month access to certain non-acute tests directly furnished by audiologists without an order.

  • Who can provide an order when needed?

    • Certified Nurse Midwives, Clinical Nurse Specialists, Clinical Psychologists, Clinical Social Workers, Interns/Residents/Fellows, Nurse Practitioners, Physician Assistants, Physicians (MD/DO), Dentists, Podiatrists, Optometrists.

  • When a test is specifically ordered by CPT descriptor

    • If a physician/non-physician practitioner orders a specific diagnostic test, only that test may be performed on that order.

    • If no specific tests are named, the audiologist may select the appropriate battery of tests.

  • Will a physician’s order guarantee reimbursement?

    • Not guaranteed; payment depends on the test’s medical necessity and the test’s purpose for diagnostic information, not the ordering person.

  • Advance Beneficiary Notice (ABN)

    • Issued when Medicare may not cover a service/item; informs patient they may be financially responsible if denied.

    • Legally required for non-covered services; protects patient rights and allows informed decisions.

Providers, Eligibility, and Student Involvement

  • Who can be reimbursed for audiology services?

    • Qualified audiologists (master’s or doctoral in audiology; licensed) or, where allowed by state law, physicians/non-physician practitioners.

  • Other personnel and reimbursement

    • Audiology services may not be reimbursed when performed by aides/technicians/others not meeting 1861(ll)(3).

    • Hearing Instrument Specialists (HIS) generally not reimbursed as they may lack required licensing.

  • Audiology students and Medicare

    • Medicare contractors generally do not pay for services requiring an audiologist’s skills if performed by AuD students or unqualified individuals.

    • AuD 4th-year students with provisional state licenses still must hold a master’s/doctorate; otherwise not billable.

  • AuD students’ billing with supervision

    • 100% direct supervision is required during Part B Medicare testing.

    • Preceptor’s NPI may be used for billing when the preceptor interacts with patient; student may assist in report writing.

Billing Codes: CPT-4 & HCPCS for Amplification

  • CPT-4 vs HCPCS overview

    • CPT-4: 5-digit codes, must align with ICD-10; often billable to Medicare/private payers; typically stronger for equivalence with services.

    • HCPCS (V-codes): Describe amplification services; Medicare often restricts reimbursement, but private insurers may reimburse.

  • Key codes (examples)

    • 92592/92593 – Hearing aid check, monaural/binaural; often paired with fitting/checking services (V5011).

    • 92594/92595 – Electroacoustic evaluation, monaural; device modifications (V5014).

    • Repair/modification: V5299.

    • Earmold impression: V5275; Earmold custom: V5264; Earmold (disposable/domEs): V5265; for mono/binaural devices: V5030–V5060 (mono) and V5120–V5267 (binaural).

    • Device style/signal processing: V5171–V5181; CROS: V5211–V5221; BiCROS: V5266.

    • Batteries: per unit (e.g., one battery per unit).

  • HCPCS dispensing codes

    • V5090, V5110, V5160, V5241, V5200, V5240, etc., for various dispensing services and fittings.

Supplier Categories, Eligibility, and Student Involvement

  • Medicare supplier category: audiology diagnostic services (other diagnostic tests); routine/annual studies typically not covered.

  • Who can be reimbursed? Audiologists with proper licensure; physicians/non-physician practitioners where allowed.

  • Students and Medicare: supervision requirements; billing under preceptor’s NPI when supervised; otherwise not billable.

OTC Regulation, FDA Pathways, and Pediatric Safeguards

  • FDA pathways for acquiring hearing aids

    • OTC Prescription Hearing Aid, Self-fitting OTC, and Hearables/Personal Sound Amplifying Devices (PSAD).

    • FDA-regulated devices are for individuals with hearing loss; FDA-regulated but not for normal-hearing individuals include HATs and some consumer devices.

  • FDA device classifications

    • Class I: OTC devices; earmold kits; Prescription A/C devices.

    • Class II: Self-fitting OTC; Prescription devices with wireless tech; B/C devices; HATs.

    • Class III: Cochlear implants.

  • 2022 changes and pediatric considerations

    • Medical referral “red flags” became ethical duties rather than mandated regulations.

    • For patients under 18, medical evaluation by a physician is mandatory and non-waivable.

  • Counseling and informed consent in OTC landscape

    • Audiologists must counsel on OTC vs prescription devices, discuss medical red flags, and document recommendations and patient decisions.

OTC Options, Counseling, and State Regulation Highlights

  • OTC option considerations

    • Best choice depends on professional evaluation and patient needs; counsel on benefits/risks of OTC vs prescription.

  • Arizona-specific regulations

    • State statutes define dispensing roles and labeling; note the FDA OTC rule and required bill of sale language including audio switch (telecoil) information and state programs for assistive devices.

  • Essential patient information and labeling requirements

    • Bill of sale must include device details, serial number, condition (new/used/rebuilt), and licensing information; notify about audio switch and relevant programs.

Pricing Models: Bundled vs Unbundled

  • Bundled pricing model

    • Patient pays upfront for device plus all included services for a defined period; visits often included at no extra charge.

    • Pros: simple for budgeting; easier revenue forecasting.

    • Cons: may obscure true service value; potential to undercharge for services.

  • Unbundled pricing model (itemized services)

    • Services priced separately from device; patient pays for services as used (e.g., fitting, verification, follow-ups).

    • Pros: transparency; supports consumer choice; easier to compare across providers; helps justify professional value.

    • Cons: more complex billing; requires clear service definitions.

  • Hybrid and packaged approaches

    • Common packages: Basic, Standard, Premium; differ in service breadth and duration.

    • Wake Forest model suggestions align codes with services: candidacy evaluation, earmold impressions, communication needs assessments, speech-in-noise tests, etc.

Sample Fee Structures and Packages

  • Sample amplification fee schedule components

    • Initial Evaluation (time-based): e.g., 1 hour; rate example.

    • Functional & Communication Needs Assessment (CNCNA): time-based; includes candidacy discussions and reporting.

    • Programming and Care/Use Instructions: device programming; patient education.

    • Trial-period adjustments and follow-ups: adjustments and verifications.

    • In-office repair and Aural Rehabilitation sessions.

    • Device selection consultations.

  • Device cost packaging examples

    • Basic Package: device cost + essential services for a defined period; example time estimate and pricing.

    • Standard Package: device cost + broader services (e.g., unlimited visits for a defined period).

    • Premium Package: device cost + extensive long-term support (more follow-ups, extended warranty, aural rehab).

  • Unbundled model examples

    • Audi Assist: device cost + orientation + verification; lower overall cost for some patients.

    • Mid/High tiers: more features like extensive verification, programming, and support.

Verification, Fitting, and Post-Fitting Coding

  • Verification CPT-4 and HCPCS codes for fitting/verification

    • 9X07X: Hearing aid fitting services (device analysis, programming, verification, counseling, orientation, training) incl. aid as applicable; first 60 minutes.

    • 9X08X: Additional minutes; 9X09X: Post-fitting follow-up (fit confirmation, benefit validation, device performance); 9X10X: Additional minutes.

  • Verification CPT-4 codes (new verification suite)

    • 9X11X: Behavioral verification (aided thresholds, functional gain, speech in noise).

    • 9X12X: Probe-microphone verification.

    • 9X13X: Electroacoustic analysis verification.

    • 9X14X: Hearing assistive device fitting (FM, DM, etc.).

    • 92596: Verification of attenuation devices (REOR).

  • Fitting verification HCPCS codes

    • V5011: Fitting/orientation/checking of hearing aid.

    • V5020: Conformity evaluation (probe microphone verification, RECD, functional gain, etc.).

Practical Takeaways for Exam Review

  • CMS billing regulations for audiology hinge on medical necessity and proper documentation of diagnostic value.

  • Distinguish bundled vs unbundled pricing; know how to justify service charges independently of device price.

  • Be familiar with common CPT-4/HCPCS codes used in amplification services and what each covers (fitting, verification, candidacy, device selection, etc.).

  • OTC vs prescription: know the FDA pathways, regulation levels, and counseling obligations for clinicians.

  • Arizona-specific considerations include licensing, labeling, and bill-of-sale requirements when dispensing hearing devices.

  • Always document medical red flags and provide informed consent, especially with OTC devices becoming more accessible.

Critical Concepts to Remember

  • CMS billing regulations related to audiology require medical necessity and appropriate testing to support diagnostic and treatment decisions.

  • Differentiate bundled pricing from itemized unbundling; understand when each is appropriate and how it affects patient decision-making.

  • CPT-4 and HCPCS codes are essential for reimbursement; keep track of which codes correspond to evaluation, fitting, verification, and device-related services.

  • Stay aware of regulatory changes around OTC hearing aids, especially for minors and the requirement for medical evaluation when necessary.

  • In states like Arizona, ensure compliance with state-specific dispensing rules and labeling requirements, including audio switch information.