Capital Bluecross Medicare Part B Coverage Update

Covered Categories

Covered Part B services include the following categories and are subject to reasonable and necessary determination:

Part B covered categories: Physician services (including surgery, consultation, office and institutional calls), outpatient hospital services incident to physician services, outpatient diagnostic services, outpatient therapy services (PT/OT/SLP), diagnostic x-ray/laboratory/other diagnostic tests, x-ray/radium/isotope therapy, surgical dressings/splints/casts, rental or purchase of durable medical equipment for home use, ambulance, prosthetic devices (excluding dental), braces and artificial limbs (including adjustments/repairs/replacements), certain medical supplies for home dialysis, RHC/FQHC services, ASC services, screening and preventive services (mammography, pap/pelvic, glaucoma, colorectal screening), vaccines (influenza, pneumococcal, hepatitis B, COVID-19), bone mass measurements, diabetes self-management services, prostate screening, and home health visits after Part A benefits exhausted.

List synthesized from Chapter 15 SMI provisions (see cited chunks).

Date of Incurred Expense

Timing of when Part B expenses are considered incurred:

General rule: Part B expenses for items and services (other than surgery and childbirth) are incurred on the date the beneficiary received the item or service, regardless of payment or order date.

See surgery/childbirth package rules for exceptions.

Surgery and childbirth exception: For surgical procedures and childbirth, all services included in the surgical/obstetrical package (preoperative/prenatal, intraoperative, and post-operative/postnatal services) are considered incurred on the date of surgery or delivery; services by other physicians are incurred on the date they were performed.

Applies whether billed as package or itemized.

Coverage and opt-out criteria

Covered when ALL of the following are met (unless exception described):

Optometrist services: Doctor of optometry services are covered when authorized under State law, medically reasonable and necessary, and meet applicable coverage requirements.

See optometrist provisions.

IOL investigational services: Eye care services related to FDA‑monitored investigational intraocular lens (IOL) studies must be furnished by the implanting ophthalmologist investigator or by a practitioner acting at the investigator's direction/supervision with agreement to report patient information to the investigator; services by others that are related to the investigation are not covered.

Special coverage rules for investigational IOLs.

Chiropractic scope: Coverage for chiropractors is limited to manual manipulation of the spine to correct a subluxation where legal; other diagnostic or therapeutic services furnished or ordered by chiropractors are not covered.

Chiropractor credentialing and x‑ray documentation referenced.

When Medicare May Pay Beneficiary for Opt-Out Provider Services

Covered claims/payments to beneficiaries when ANY of the following apply:

Medicare payment to beneficiary for opt‑out practitioner services: Medicare may pay a beneficiary for services of an opt‑out physician/practitioner if: (a) the services were emergency or urgent care furnished to a beneficiary with whom the practitioner has not previously entered into a private contract; OR (b) the practitioner failed to privately contract for non‑emergency/non‑urgent services furnished no later than 15 days after MAC notice of opt‑out (subject to contractor review).15 days

Contractor must contact opt‑out practitioner to ascertain existence of private contract and may request the private contract copy before denying beneficiary claim.

Effect of MAC Notice and 15-day Rule

Post‑notice payment rule: If a beneficiary did not enter into a private contract and did not receive notice from the A/B MAC that the physician/practitioner opted out, Medicare may pay for non‑emergency/non‑urgent services furnished before the earlier of (a) the beneficiary receiving an opt‑out private contract or (b) 15 days after the MAC's notice; services furnished more than 15 days after MAC notice or when a private contract exists are not payable by Medicare.15 days

If practitioner fails to provide a copy of private contract within 45 days of MAC request, MAC must pay beneficiary as for a nonparticipating practitioner and notify beneficiary regarding future payments.

Nullification and Sanctions for Improper/Maintenance Failures

Nullification for improper opt‑out: If a physician/practitioner fails to properly opt‑out (e.g., private contracts predate the required affidavit or affidavits not filed per §40.9), the attempted opt‑out is nullified, all private contracts for that 2‑year period are void, and the practitioner must submit claims to Medicare; nonparticipating limiting charge rules apply.

Practitioner may not bill or collect except applicable deductible/coinsurance until remedies applied.

Sanctions for failure to maintain opt‑out: If practitioner fails to maintain opt‑out (knowingly submits claims or receives Medicare payment, fails to enter/retain valid private contracts, or violates emergency/urgent billing rules), the contractor will notify the practitioner and if good‑faith remediation is not demonstrated within 45 days, nullify contracts, nullify opt‑out, require claim submission, apply limiting charge provisions for remainder of opt‑out period, and prohibit re‑opting out until period ends.45 days

Remedies may apply retroactively to date of first violation if discovered later.

Private Contract Mandatory Elements

Private contracts must meet ALL of the following:

Written and readable: Contract must be in writing, printed in legible type large enough for beneficiary to read, and signed by both beneficiary (or legal representative) and physician/practitioner.

Original signed contract must be retained by practitioner for duration of each 2‑year opt‑out period and made available to CMS.

Required statements and acknowledgements: Contract must state whether practitioner is excluded under specified sections of the Act; state beneficiary accepts full payment responsibility and waives Medicare claims; state Medicare limits do not apply to practitioner charges; state beneficiary agrees not to submit claim to Medicare; state that Medicare payment will not be made for services furnished under the contract; inform beneficiary of right to obtain Medicare‑covered services from non‑opt‑out providers; state expected effective and expiration dates of the 2‑year opt‑out period; and explain Medigap implications.

Contract must not be entered into during emergency/urgent care and must be provided to beneficiary before services are furnished (photocopy permissible).

Retention and filing: Contract must be retained with original signatures by the physician/practitioner for the duration of the current 2‑year opt‑out period, be made available to CMS upon request, and be entered into for each 2‑year opt‑out period.

Opt-out Affidavit Filing and Renewal

Affidavit automatic renewal and contents: Affidavits filed on or after June 16, 2015, automatically renew every 2 years unless practitioner cancels automatic renewal in writing at least 30 days before the next period; affidavits signed before June 16, 2015, expire after 2 years and require renewal within 30 days after expiration to extend opt‑out. A valid affidavit must be written, signed, include full identifying information (name, address, phone, NPI or TIN), state commitment to provide services only via private contracts (except emergency/urgent care), acknowledge termination of Part B participation agreement if applicable, and be filed with all MACs with jurisdiction.30 days

Initial 2‑year opt‑out period begins on affidavit signature date if filed within 10 days after signing first private contract.

Opt-Out Scope

Covered status and scope of opt-out

Scope of opt‑out election: Opt‑out applies to all Medicare‑covered items and services furnished by the physician/practitioner; private contracts cannot be limited to some covered services and not others (opt‑out covers lab, DMEPOS incident to professional services, and all covered items/services the practitioner furnishes).

Opt‑out election is nationwide for the practitioner and must be implemented via private contracts for each beneficiary except for emergency/urgent care exceptions.

Participation and Payment Effects

Effect on participation and payment

Participation status and payment rates: Participating physicians who validly opt out must file affidavits at least 30 days before a quarter start to have the opt‑out effective at quarter start; participating status terminates on the affidavit effective date. Services before the effective date are paid at participating rates; services on/after the opt‑out date are paid at nonparticipating rates (nonparticipating rate equals 95% of participating physician payment amount).30 days

Medicare contractor must update participating status at quarter boundaries.

Emergency/Urgent Care Coverage

Emergency and urgent care exceptions — covered when specific conditions are met

Emergency/urgent care by opt‑out practitioners: When an opt‑out physician/practitioner furnishes emergency or urgent care to a beneficiary with whom they have no private contract, the practitioner must submit a Medicare claim with appropriate HCPCS code and the GJ modifier; practitioner may collect no more than the Medicare limiting charge (physician) or only deductible/coinsurance if taking assignment (practitioner). Failure to submit the GJ modifier will cause denial to enable beneficiary appeal.

Covered until beneficiary no longer needs emergency/urgent care; follow‑up non‑urgent care requires private contract or referral to non‑opt‑out provider.

Claims Handling and Enforcement

Contractor actions on improperly filed or beneficiary‑filed claims

Claims handling and enforcement: For wrongly filed claims, contractors must hold claims in suspense, request practitioner response, and if confirmed filed in error, deny and notify beneficiary that they are responsible. If no response or willful failure to maintain opt‑out, contractor must notify practitioner that effects in §40.11 apply (nullify opt‑out/contracts, require claim submission, apply limiting charge rules) and proceed with appropriate enforcement actions. If beneficiary appeals alleging no private contract, contractor must request a copy of the private contract and, absent an acceptable contract, pay the beneficiary and proceed.

Contractor timelines and development letter procedures apply.

Emergency/Urgent Care by Opt-Out Providers

Covered when ALL of the following are met

Opt‑out emergency/urgent coverage conditions: Service furnished by an opt‑out physician/practitioner who has not entered into a private contract with the beneficiary; situation meets CMS definition of emergency or urgent care; claim submitted with appropriate HCPCS modifier(s) (e.g., GJ); practitioner collects no more than Medicare limiting charge (or deductible/coinsurance if taking assignment).

GJ modifier required; omission triggers denial to allow beneficiary appeal.

Medicare Part B Drugs and Biologicals

Covered when ALL of the following are met

Part B drugs and biologicals general criteria: Drugs/biologicals meet statutory definition and compendia/hospital committee criteria; are not usually self‑administered by patients for the indication; meet incident‑to coverage requirements where applicable; route of administration is medically reasonable and necessary; and use is reasonable and necessary for diagnosis/treatment per accepted standards of medical practice.

A/B MACs determine self‑administration status and appropriateness of injectable versus oral forms.

Coverage and incident-to criteria

Covered only when drugs and administration meet incident‑to and reasonable/necessary criteria; excluded when usually self‑administered by Medicare beneficiaries.

Incident‑to coverage core requirements: To be covered as incident‑to a physician's service, an FDA‑approved drug/biological must: (1) be a form not usually self‑administered; (2) be furnished by a physician; and (3) be administered by the physician or auxiliary personnel under the physician's personal (direct) supervision. The charge for the drug must be included in the physician's bill and represent an expense to the physician.

See 50.3 incident‑to requirements.

Route and self‑administration presumptions: Absent evidence, IV and IM drugs are presumed not usually self‑administered; subcutaneous drugs are presumed usually self‑administered. Factors such as acute condition, frequency of administration, and indication‑specific usage weights inform determinations; 'usually' means >50% of Medicare beneficiaries' use.>50%

MACs must make per‑indication determinations and weighted overall decisions.

FDA approval requirement:

Approved Use of Drug

Covered when ALL of the following are met

Labeled (FDA‑approved) drug use: The drug/biological is FDA‑approved for marketing and was injected on or after the FDA approval date; the use is reasonable and necessary for the individual patient; and all other applicable coverage requirements are met. The MAC will obtain satisfactory evidence of FDA approval when needed.

Acceptable evidence of approval includes FDA approval letter, FDA product listings, manufacturer's package insert, or FDA website information.

Unlabeled/Off‑Label Use

Covered when ANY of the following evidentiary conditions are met and MAC determines the use medically accepted

Off‑label / unlabeled use acceptance: Off‑label use may be covered if the MAC determines the use is medically accepted based on support from major compendia (e.g., NCCN, AHFS‑DI, DrugDex, Clinical Pharmacology, Lexi‑Drugs) or by peer‑reviewed medical literature and accepted standards of practice; for anti‑cancer regimens, compendia or peer‑reviewed literature support may be required and evaluated case‑by‑case.compendia listing or peer‑reviewed evidence

Contractor may request compendia citations or peer‑reviewed literature from treating physician.

Pneumococcal Vaccine Coverage

Pneumococcal vaccine coverage rules (selected highlights)

Routine pneumococcal series for adults ≥65 and at‑risk adults 19‑64: Adults ≥65 who have not previously received a pneumococcal conjugate vaccine should receive one dose of PCV20 or PCV15; if PCV15 is used it should be followed by PPSV23 per interval guidance. Adults 19‑64 with specified risk factors should receive PCV20 or PCV15 (if PCV15 used, follow with PPSV23). Clinical risk groups and sequencing intervals are specified by ACIP guidance.

When PCV15 is used, recommended interval to PPSV23 is ≥1 year for routine cases; minimum 8 weeks may be used for certain high‑risk/immunocompromised groups.

Special prior vaccination histories: For adults with prior PPSV23 or combined PCV13+PPSV23 histories, CMS provides specific guidance on whether PCV20 or PPSV23 is recommended and required intervals (e.g., ≥1 year after PPSV23 to give PCV; shared clinical decision‑making and ≥5 years intervals apply in certain prior series scenarios).

Providers may rely on patient history when records are unavailable.

In‑Home Vaccine Administration Payment

Additional in‑home payment may be made when ALL of the following apply

In‑home vaccine administration payment conditions: Sole purpose of the home visit is administration of one or more preventive Part B vaccines; the patient has difficulty leaving home or faces barriers to vaccination outside the home; the home is not an institution; and the furnisher documents the patient's clinical status or barriers in the medical record. Only one additional in‑home payment is allowed per patient per home visit even if multiple vaccines are administered; each vaccine still receives its own administration payment.

Applies to pneumococcal, influenza, hepatitis B, and COVID‑19 vaccines under specified effective dates.

Antigens

Antigens prepared for a particular patient may be covered when ALL of the following are met

Patient‑specific antigen coverage: Antigens must be prepared by an MD/DO for a particular patient after physician examination with a determined treatment plan and dosage regimen; antigens must be administered per the plan by a physician or a properly instructed person under physician supervision. A reasonable supply is not more than a 12‑month supply prepared for that patient.12‑month supply

Purpose of supply limit is to preserve antigen potency.

Part B Vaccine Coverage

Covered when the specified beneficiary risk/status and furnishing requirements are met

Hepatitis B vaccine coverage: Hepatitis B vaccine and administration are covered for beneficiaries at high or intermediate risk as identified (including ESRD patients, certain institutionalized individuals, household contacts of HBV carriers, illicit injectable drug users, persons with diabetes, and specified occupational groups), except when laboratory evidence documents prior immunity.

ESRD patients have separate administration payment handling.

Influenza vaccine coverage: Influenza vaccine and administration are covered when furnished in compliance with state law by any provider or entity with a supplier number; typically once per flu season; physician order not required.

Beneficiary may receive vaccine upon request without physician order.

COVID‑19 vaccine coverage: COVID‑19 vaccines and administration are covered when furnished in compliance with state law by any provider or entity with a supplier number; coverage effective dates and payment details are available via CMS vaccine pricing resources; physician order not required.

Coverage criteria

Covered when ALL of the following are met (separate branches for off‑label anti‑cancer use and immunosuppressive/EPO coverage):

Off‑label anti‑cancer drug use: FDA‑approved anti‑cancer drugs used off‑label in a chemotherapeutic regimen are covered when the off‑label indication is medically accepted, supported by listed compendia or peer‑reviewed medical literature; contractors may request compendia or literature evidence and will evaluate relevance of patient/regimen/outcomes and study quality.compendia listing or peer‑reviewed evidence

Compendia list includes AHFS‑DI, NCCN, DrugDex, Clinical Pharmacology, Lexi‑Drugs with specified supportive ratings.

Acceptable compendia: Uses supported by AHFS‑DI, NCCN Drugs & Biologics Compendium, Micromedex DrugDex, Clinical Pharmacology, or Lexi‑Drugs (with specified supportive ratings) are considered medically accepted for anti‑cancer off‑label coverage.compendium‑specific ratings

Absence of narrative is neither supportive nor non‑supportive.

EPO coverage (home and dialysis facility)

Covered when ALL of the following are met for dialysis patients using EPO at home or in facility:

Setting: EPO is administered in the renal dialysis facility or self‑administered in the home by a competent dialysis patient or caregiver; payment under 'incident to' is not allowed when administered in the dialysis facility.

Office setting receives administration charge only for non‑ESRD patients.

Patient care plan and monitoring: A current care plan must exist for monitoring home EPO including diet/fluid review, medication review for iron supplementation, ongoing hematocrit and iron store evaluations, dialysis prescription reevaluation, physician/facility follow‑up on blood tests (patient log), patient training on hypotension/hypertension signs, and discontinuance criteria for uncontrolled hypertension.

Copy maintained by backup facility for Method II patients.

Preselection monitoring: Measure hematocrit/hemoglobin, serum iron, transferrin saturation, serum ferritin, and blood pressure prior to selection for home EPO.

Laboratory and vitals required before initiation.

Oral anti-cancer drug Part B coverage

Oral anti-cancer drugs are covered under Part B when ALL of the following are met:

Oral anti‑cancer drug coverage criteria: Drug is prescribed by a licensed physician/practitioner; is FDA‑approved; has the same active ingredients and is used for the same indications as a covered non‑self‑administrable anti‑cancer agent (same chemical/generic name per Orange Book/PDR/compendia); and use is reasonable and necessary for the individual patient.

Unlabeled uses are allowed if same as non‑self‑administrable version and medically necessary.

Oral anti-emetic coverage

Covered when ALL of the following are met:

Oral anti‑emetic coverage: Oral anti‑emetic is FDA‑approved for anti‑emetic use; is administered by the treating physician or per a physician's written order as part of a chemotherapy regimen; is initiated within 2 hours of chemotherapy administration and supply does not exceed 48 hours from that time; and is used as a full therapeutic replacement for the IV anti‑emetic that would otherwise be administered.Initiate within 2 hours; supply ≤48 hours

IV anti‑emetics may be covered when patient fails oral therapy.

Home hemophilia clotting factors

Covered when ALL of the following are met:

Home hemophilia clotting factors: Patient has factor VIII or IX deficiency or von Willebrand's disease; patient is competent to use clotting factors to control bleeding without medical supervision; quantity covered based on contractor‑developed historical utilization profile for each patient with adjustments for extraordinary events or changing needs.

Competence to self‑administer is required for home coverage.

Home IVIG coverage

Covered when ALL of the following are met:

Home IVIG coverage: Patient has a diagnosed primary immune deficiency disease (ICD‑10 codes listed); IVIG is administered in the patient's home and the physician determines home administration is medically appropriate; CMS permanent bundled payment to a DME supplier applies for home IVIG items and services furnished on or after 1/1/2024.

Pump may or may not be included; pump not covered under the bundled home IVIG payment.

Standard Incident-to Coverage

Covered when ALL of the following are met:

Incident‑to general requirements: Services/supplies furnished incident to a physician's professional service must be an integral, incidental part of the physician's personal professional service; commonly rendered without charge or included in the physician's bill; commonly furnished in physician offices or clinics; and furnished by the physician or by auxiliary personnel under the physician's direct personal supervision. The charge for the service/supply must represent an expense to the billing physician/legal entity.

Direct personal supervision and reassignment relationship requirements apply.

Nonphysician Practitioner Incident-to Conditions

For nonphysician practitioners acting as auxiliary personnel:

Nonphysician practitioner incident‑to conditions: Nonphysician practitioners (e.g., PAs, NPs, CNSs) may have services covered as incident to a physician's services only if all incident‑to requirements are met: services must be integral to the physician's service, initiated by physician, performed under direct physician supervision (physician physically present in office suite and immediately available), and reflect ongoing physician active participation and management of the course of treatment.

Even if state law permits independent performance, incident‑to coverage requires physician initiation and direct supervision.

Homebound/General Supervision Exception

Homebound/medically underserved exception (general supervision):

Homebound general supervision exception core: Patient must be homebound; service must be an integral part of the physician's service and ordered by the physician; service may be performed under general (not direct) physician supervision with maintained contact and physician retaining professional responsibility; services must be included in the physician/clinic bill and represent an expense to the billing entity; services must be reasonable and necessary.

Direct supervision requirement is not applicable to listed intermittent services when criteria are met.

Allowed intermittent services under general supervision: Examples include injections, venipuncture, EKGs, therapeutic exercises, catheter insertion/sterile irrigation, dressing changes, NG tube replacement, fecal impaction removal including enemas, sputum collection, paraffin bath therapy, and teaching/training for ostomy/tracheostomy/diabetic foot care/blood pressure monitoring, when performed under the homebound exception criteria.

These services are covered under relaxed supervision when all homebound exception criteria are satisfied.

Sleep Clinic Diagnostic Coverage

Diagnostic tests in sleep disorder clinics are covered when ALL of the following are met:

Sleep clinic diagnostic coverage criteria: (1) Clinic is affiliated with a hospital or under physician direction/control (testing may be covered even without direct physician supervision); (2) patient referred by attending physician and clinic maintains attending physician's orders; (3) need for diagnostic testing is confirmed by medical evidence (physician exams, lab tests); (4) patient has symptoms/complaints of a covered sleep condition (narcolepsy, sleep apnea, parasomnia, impotence in limited cases); and (5) number of testing sessions limited to customary amounts unless persuasive medical evidence justifies additional tests.see ordinary session limits

Duplicative diagnostic testing that repeats prior pertinent testing is not covered.

Not Covered: Polysomnography for Chronic Insomnia

Polysomnography for chronic insomnia: Polysomnography in a sleep disorder clinic for chronic insomnia is not covered because evidence does not show diagnostic utility or improved clinical outcomes; this use is not reasonable and necessary.N/A

Explicit noncoverage under §1862(a)(1)(A).

Supervision Requirements

Supervision for diagnostic tests: Diagnostic tests payable under the physician fee schedule must be furnished under the appropriate level of supervision by a physician or, to the extent authorized by scope of practice and State law, by an NP, CNS, CNM, CRNA, or PA. Supervision levels (general, direct, personal) are defined and numeric levels are assigned to CPT/HCPCS codes in the MPFS RVU file. Services furnished without required supervision are not reasonable and necessary.N/A

Some exceptions apply for qualified psychologists and audiologists.

Independent Laboratory Home/Institution Visits

Independent laboratory home/institution visit criteria: An independent laboratory visit to obtain a specimen is covered when: (A) the patient is confined to home (homebound) and specimen collection requires technician skills (e.g., venipuncture), OR (B) the patient's place of residence is an institution that does not perform venipuncture and the patient is confined to that facility and facility lacks qualified on‑duty personnel. Specimen pickup services not requiring technician skill (e.g., urine) are not considered medically necessary for a visit.

Applies to independent laboratories only.

Psychological and Neuropsychological Testing

Psychological/neuropsychological testing coverage: Psychological and neuropsychological diagnostic tests are covered under §1861(s)(3); technician/computer CPT codes reflect site‑of‑service payment differentials and are not payable as 'incident to.' Supervision exceptions allow a clinical psychologist or physician to provide general supervision for these diagnostic tests; NPs/CNSs/PAs follow their respective benefit supervision/collaboration rules when personally performing tests.

Payment and supervision distinctions outlined; CPT code guidance applies.

Venipuncture at Place of Residence that is an Institution

Independent laboratory venipuncture at a non‑hospital facility is medically necessary only when ALL of the following are met:

Institutional venipuncture criteria: (a) The patient was confined to the facility; and (b) The facility did not have on‑duty personnel qualified to perform venipuncture. When facility personnel obtain and prepare specimens for pickup, the laboratory's pickup service is not separately necessary.

Applies to independent laboratories only and does not expand 'incident to' coverage.

Covered Reasons for Audiology Diagnostic Testing

Audiology diagnostic tests are covered when performed for the purpose of obtaining information necessary for physician's diagnostic evaluation or to determine appropriate medical/surgical treatment, and when ANY of the following clinical reasons apply:

Appropriate reasons for audiology testing: Evaluation of suspected change in hearing/tinnitus/balance; evaluation of cause of hearing/tinnitus/balance disorders; determination of effect of medication, surgery, or other treatment; reevaluation of progressive or fluctuating conditions; failure of a screening test; diagnostic analysis/programming of cochlear or brainstem implants; testing before and periodically after auditory prosthetic implantation; testing related to signs/symptoms referred by a physician.

Coverage determined by reason for test rather than diagnosis alone; tests ordered without physician/NPP order are not covered.

Provider Qualifications and Supervision

Who may furnish or bill diagnostic tests and what supervision is required:

Provider qualifications and supervision rules: Clinical psychologists or physicians may provide general supervision for diagnostic psychological/neuropsychological tests; NPs/CNSs performing such tests must do so in collaboration with a physician; PAs perform under general physician supervision. Qualified audiologists may furnish audiology services as authorized by State law and are excepted from physician supervision when personally furnishing tests. When a physician orders a technician to perform an audiology test, the technician must work under direct physician supervision and perform only the specified test.

Documentation and credential verification requirements for providers apply.

Conditions for Coverage (BMM)

Covered when ALL of the following are met:

BMM general conditions: 1) Ordered by the treating physician or qualified nonphysician practitioner after evaluation; 2) Performed under appropriate physician supervision; 3) Reasonable and necessary for diagnosing/treating a beneficiary who meets eligibility conditions; 4) For monitoring response to FDA‑approved osteoporosis drug therapy, performed with dual‑energy x‑ray absorptiometry (axial skeleton); 5) Confirmatory BMMs must be dual‑energy axial if initial BMM was not dual‑energy axial.

Frequency and beneficiary eligibility criteria are specified separately.

Eligible Beneficiaries

Beneficiaries who may be covered (at least one required):

Eligible beneficiary categories: 1) Woman determined estrogen‑deficient and at clinical risk for osteoporosis; 2) Individual with vertebral abnormalities on x‑ray indicative of osteoporosis/osteopenia/fracture; 3) Individual receiving or expecting ≥5.0 mg prednisone equivalent per day for >3 months; 4) Individual with primary hyperparathyroidism; 5) Individual being monitored for response to FDA‑approved osteoporosis drug therapy.

Meeting at least one condition qualifies beneficiary for covered BMM.

Testing Facility Furnishing Additional Tests Without New Order

Testing facility may furnish additional diagnostic tests without a new order only when ALL of the following are met:

Criteria to perform additional tests without new order: (1) The testing center performs the diagnostic test ordered by the treating physician/practitioner; (2) The interpreting physician determines and documents that, because of an abnormal result of the performed test, an additional diagnostic test is medically necessary; (3) Delaying performance of the additional test would adversely affect beneficiary care; (4) The result is communicated to and used by the treating physician/practitioner in treatment; and (5) The interpreting physician documents in the report why additional testing was done.

Applies when testing facility cannot reach the treating physician and documents attempts.

Interpreting Physician Determination of Different Test

If an interpreting physician determines the ordered diagnostic radiology test is clinically inappropriate or suboptimal:

New order required before performing different test: The interpreting physician/testing facility may not perform an unordered diagnostic test until a new order from the treating physician/practitioner has been received; similarly, if the ordered test result is normal but a different test is believed appropriate, a new order is required prior to performing the unordered test.

Ensures treating physician authorizes change in diagnostic testing plan.

Surgical/Cytopathology Exception

Pathologist may perform additional tests without a specific request when ALL of the following are true:

Surgical/cytopathology exception criteria: (1) Additional tests are medically necessary to complete an accurate diagnosis; (2) Results are communicated to and used by the treating physician/practitioner in the patient's treatment; and (3) The pathologist documents in the report why additional testing was done.

Applies to independent or hospital pathologists furnishing pathology services for non‑inpatient/outpatient beneficiaries when no specific additional tests were requested.

Payment for services under Medicare Part B is not allowed when the same services are payable under Part A (for example, when expenses were used to satisfy a Part A deductible or coinsurance). If a service qualifies for payment under Part A, it should not be billed to Part B.

For FDA‑monitored investigational intraocular lens (IOL) studies, all eye care services related to the investigation must be furnished by the implanting ophthalmologist investigator or by a practitioner providing services under the investigator’s direction or supervision with an agreement to report patient information to the investigator. Services furnished by others that are related to the investigation are not covered.

An opt‑out physician/practitioner is not required to execute a private contract for items or services that are categorically excluded from Medicare coverage. Private contracts are required only for items or services that are, or may be, covered by Medicare.

Items or services that Medicare categorically does not cover (for example, hearing aids) do not require a private contract when furnished to beneficiaries; Medicare claims filing rules and limits on charges do not apply to such categorically noncovered items.

Medicare Part B generally excludes drugs that are usually self‑administered by the patient (for example, most oral drugs, suppositories, and topical medications). There are statutory exceptions (e.g., blood‑clotting factors, certain immunosuppressive drugs, erythropoietin for dialysis patients, specified oral anti‑cancer drugs and certain anti‑emetics).

Drugs intended for continued use at home or routine chronic oral medications, and medicines not integral to a procedure, are not treated as Part B injectable supplies; such outpatient drugs given for continued home use are typically not covered as Part B supplies.

Preventive immunizations that are not directly related to treatment of an injury or direct exposure are excluded from Part B coverage (examples: routine smallpox, polio, diphtheria), except for specific vaccines such as pneumococcal, hepatitis B, influenza, and COVID‑19 which have separate coverage rules.

Compendia and evidence categories that do not support off‑label coverage include indications listed as Category 3 in NCCN or Class III in DrugDex, narratives judged 'not supportive' in AHFS‑DI or Clinical Pharmacology, or entries in Lexi‑Drugs listed as 'Use: Unsupported'. The absence of narrative is considered neither supportive nor non‑supportive.

Erythropoietin (EPO) coverage for non‑ESRD uses must meet separate §50 requirements; however, for dialysis patients EPO is covered when administered in the renal dialysis facility or self‑administered in the home by a competent patient or caregiver who meets program conditions. Separately, oral anti‑cancer drug coverage under Part B is permitted only when statutory and policy criteria for oral anti‑cancer drugs are satisfied.

Services furnished under the homebound/general‑supervision exception are not intended to substitute for home health services; when a participating Home Health Agency (HHA) is available to provide needed skilled services on a timely basis, physician/clinic provision of those services may be subject to postpayment review and denial.

Polysomnography performed for the diagnosis of chronic insomnia in a sleep disorder clinic is explicitly not covered because it is not considered reasonable and necessary under §1862(a)(1)(A).

Medicare does not pay audiologists for therapeutic services such as vestibular treatment, auditory rehabilitation, auditory processing therapy, or canalith repositioning; these services are not payable as audiology services under the statutory definition.

Audiology diagnostic testing is payable only when ordered by a physician (or applicable NPP) for purposes of the physician’s diagnostic evaluation or to determine appropriate medical/surgical treatment. Tests performed without a physician or applicable NPP order are not covered.

The following bone mass measurement modalities are explicitly noncovered and considered not reasonable and necessary under §1862(a)(1)(A): single‑photon absorptiometry and dual‑photon absorptiometry.

Procedures that require physician‑level medical judgment, fluoroscopy, contrast media administration, injections, special technical competency, or special equipment are not appropriate to provide under portable/office arrangements and, where such skills or equipment are required, the service should not be furnished in a typical office setting.

When an interpreting physician determines an ordered diagnostic radiology test is clinically inappropriate or suboptimal and a different test is required, the interpreting physician/testing facility may not perform that unordered test until a new order from the treating physician/practitioner has been received. Separately, testing facilities may furnish additional tests without a new order only when specified criteria are met, including documentation that delay would adversely affect care and that results will be used by the treating physician.

If a testing facility performs an additional diagnostic radiology test that was not ordered, it risks noncoverage; the facility must obtain a new order from the treating physician before performing the unordered test.

If a supplier breaches a contract to make a custom device (for example, an unexcused failure to deliver within the contract timeframe), Medicare may refuse payment for work or materials expended on that item.

Chiropractic maintenance therapy—care intended to prevent disease, promote health, or maintain a chronic condition when further clinical improvement is not expected—is not medically reasonable or necessary and therefore is not payable under Medicare.

When a drug is available in both oral and injectable forms, the injectable route must be medically reasonable and necessary compared with the oral route; injectable formulations are not covered if parenteral administration is not indicated by standard medical practice (for example, when oral therapy is accepted and effective).

Drugs excluded because they are usually self‑administered are considered a benefit category denial rather than a medical‑necessity denial; an Advance Beneficiary Notice (ABN) is not applicable to this exclusion and providers may bill beneficiaries when appropriate.

Examples of medications that would be considered not reasonable and necessary include drugs given for general good rather than treatment of a particular illness (e.g., vitamins), parenteral medications when an oral route is the accepted standard, and medications given at excessive frequency or duration beyond accepted practice; when determined not reasonable and necessary, both drug and administration charges are excluded.

Contractors may deny coverage for off‑label uses when peer‑reviewed medical literature or CMS/FDA/compendia determinations demonstrate that the off‑label use is not safe or effective. Uses identified by CMS or the FDA as not indicated, or uses listed as unsupported in the recognized compendia, are noncovered.

Preoperative use of Procrit (erythropoietin) is generally considered a preventive service and not covered, except in narrowly defined situations where an A/B MAC (B) determines it reasonable and necessary (for example, select hip/knee surgery patients meeting listed criteria).

Supplies or services that are not commonly furnished in a physician's office or that are not medically appropriate to provide in the office setting are not covered under the incident‑to provision and should not be billed as such.

Duplicative diagnostic testing that repeats prior pertinent testing whose results remain pertinent is not medically necessary and not covered. In addition, polysomnography for chronic insomnia is explicitly noncovered.

Audiology diagnostic tests furnished without an order from a physician or an applicable nonphysician practitioner (NPP) are not covered and therefore are subject to denial; when ordered, the reason for the test must be documented in the order or medical record.

Provider Obligations, Billing Rules, and Denial Risks

Billing Rule

Emergency/Urgent Care Claim Filing (GJ modifier required)

For emergency or urgent care furnished by an opt‑out physician/practitioner to a beneficiary with whom the provider has not previously entered into a private contract, the provider must submit a completed Medicare claim on behalf of the beneficiary and include the GJ modifier to indicate the service was emergency/urgent care by an opt‑out provider. Failure to submit the GJ modifier may cause the contractor to deny the claim and prevent the beneficiary from appealing.

Use GJ = Opt‑out physician/practitioner EMERGENCY OR URGENT SERVICES modifier
If GJ is missing the claim may be denied
If emergency care transitions to non‑urgent follow‑up, provider must ask beneficiary to sign a private contract for subsequent care

Documentation Required

Off‑label Anti‑cancer Drug Coverage — documentation required

Off‑label uses of FDA‑approved anti‑cancer drugs may be covered when the treating physician documents that the use is a medically accepted indication supported by one or more of the listed compendia or by peer‑reviewed medical literature. Contractors may request compendia citations or peer‑reviewed literature from the treating physician when assessing coverage.

Supported compendia include AHFS‑DI, NCCN, DrugDex, Clinical Pharmacology, and Lexi‑Drugs
Uses categorized as unsupported/not indicated in the listed compendia are not medically accepted
Contractor may maintain subscriptions or request supporting documentation from treating physician

Billing Rule

BMM ordering, supervision, and frequency

Bone mass measurements (BMM) must be ordered by the treating physician or qualified NPP and performed under the appropriate level of physician supervision. Frequency limits apply (screening BMM once every 2 years) but more frequent testing may be paid when medically necessary. Non‑covered modalities (e.g., single photon, dual photon) must not be billed.

Order must come from treating physician or qualified NPP
Testing must be performed under required physician supervision per 42 CFR 410.32(b)
Screening BMM paid once every 2 years (>=23 months since prior) unless medical necessity justifies more frequent testing
Single photon and dual photon absorptiometry are noncovered

Note

Claims Processing and NCD Note

Follow Medicare Claims Processing Manual Chapter 13, §140 for payment methodology, HCPCS coding, and summary notice/remittance advice messages related to BMM and related claims. Refer to the NCD process for national coverage guidance when applicable.

See Pub. 100‑04, Medicare Claims Processing Manual, Chapter 13, §140 for billing instructions
Use NCDs and CMS guidance when national determinations apply

Documentation Required

IOL study coverage limitation

All eye care services related to an FDA‑monitored investigational intraocular lens (IOL) must be provided by the investigator (implanting ophthalmologist) or by a practitioner acting at the investigator's direction or under the investigator's supervision and who has an agreement to report patient information to the investigator. Services not related to the investigation are not covered during the investigational period when furnished by other providers.

Investigator or supervised practitioner must furnish study‑related eye care
Practitioners assisting the investigator must agree to report patient information to the investigator
Services not related to the IOL investigation furnished by others are not covered during the investigation

Billing Rule

Claims submitted by a beneficiary for services of an opt‑out provider

When a beneficiary submits a claim for services furnished by an opt‑out physician/practitioner, the contractor must contact the opt‑out provider to determine whether a valid private contract exists. If the provider does not produce a valid private contract and no prior notice was given, Medicare may pay the beneficiary for non‑emergency services furnished no later than 15 days after the MAC's opt‑out notice. If the provider does not respond within 45 days to a request for the private contract, the contractor must pay the beneficiary as a nonparticipating provider for that service and notify the beneficiary of limitations going forward.

Contractor must request copy of private contract before denying beneficiary claim
If no private contract and provider failed to notify beneficiary, payment may be made for services furnished <=15 days after contractor's opt‑out notice
If provider fails to respond within 45 days, contractor pays beneficiary as nonparticipating provider for that service

Denial Risk

Claims submitted for services by an opt‑out provider — denial and notice rules

Claims submitted by or for services furnished by an opt‑out physician/practitioner are generally denied unless emergency/urgent exception or other narrow exceptions apply. The contractor must use specific remittance and MSN language when denying such claims and follow procedures for investigation when multiple beneficiary‑filed claims suggest problems with private contracts.

If claim submitted by opt‑out provider, contractor denies and sends provider remittance and beneficiary MSN per §40.38/§40.39
Beneficiary‑filed claims get MSN #21.20
Repeated beneficiary submissions trigger contractor investigation to verify private contracts

Denial Risk

Triggers for denial — common denial risk conditions

Denial triggers include: services usually self‑administered (>50% of Medicare users) when billed incident to; drugs without FDA marketing approval; injectable route used when oral route is standard and adequate; excessive frequency or duration beyond accepted practice; and services lacking required supervision, orders, or documentation. Noncovered or unsafe off‑label uses identified by CMS/FDA or compendia may also trigger denials.

Drug considered 'usually self‑administered' (>50%) — excluded from Part B coverage
Injectable route not reasonable/necessary when oral form is effective
Excessive frequency/duration beyond accepted standards leads to exclusion of entire charge
Drugs without FDA approval are denied unless CMS instructs otherwise
Services furnished without required supervision, order, or documentation may be denied

Billing Rule

Interpreting Physician Cannot Perform Unordered Test

If the interpreting physician at a testing facility determines that the ordered diagnostic test is clinically inappropriate and a different or additional test is required, the facility may not perform the unordered test until a new order from the treating physician/practitioner is received. Exceptions apply only when the testing facility documents attempts to reach the treating physician and criteria for emergency additional testing are met.

Interpreting physician cannot perform unordered test without new order from treating physician
If the treating physician cannot be reached, testing facility may perform additional test only when all §80.6.3 criteria are documented
Testing facility must document contact attempts and rationale in the medical record

Billing Rule

Claims should show HCPCS codes and from/to dates

Claims must show HCPCS codes and service dates on the CMS‑1500 (HCPCS codes and from/to dates) or HCFA/CMS‑1450 (UB‑04) outpatient claim (HCPCS code and date of service) as applicable. Ensure HCPCS modifiers (e.g., GJ) are included when required.

CMS‑1500: show HCPCS codes and from/to dates of service
CMS‑1450 (UB‑04) outpatient claim: show HCPCS code and date of service
Include required HCPCS modifiers (e.g., GJ for opt‑out emergency/urgent claims)

Documentation Required

Physician/practitioner must retain original orders and medical evidence

Treating physicians/practitioners must retain original orders and relevant medical evidence in the patient's record. For diagnostic testing, the facility must maintain the attending physician's orders and supporting medical evidence so the MAC can determine medical necessity during review.

Orders may be written, telephone (documented by both parties), or electronic; telephone orders must be documented by physician/office and testing facility
Testing facility must retain attending physician orders and supporting medical evidence for diagnostic tests

Documentation Required

Supporting evidence for off‑label anti‑cancer use — contractor may request documentation

When assessing off‑label anti‑cancer drug claims, contractors may request supporting evidence such as compendia citations or peer‑reviewed literature from the treating physician. The contractor will consider the listed compendia and peer‑reviewed publications to determine whether the off‑label use is a medically accepted indication.

Contractor may request compendia excerpts or peer‑reviewed articles from treating physician
Medically accepted off‑label use is supported by listed compendia or peer‑reviewed literature
A use listed as 'unsupported' or 'not indicated' in the compendia is not medically accepted

Documentation Required

The reason for the audiology test must be documented

Diagnostic audiology tests require a physician (or NPP) order. The reason for the audiology test must be documented on the order, the audiology report, or elsewhere in the medical record. Records supporting the reason for testing must be available for MAC review on request.

Order must state the reason for the test (on the order, report, or medical record)
If testing performed without a physician order, it is not covered even if pathology is found
Testing records must support medical necessity and be available for MAC review

Documentation Required

Anti‑emetic escalation — IV anti‑emetics after oral therapy failure

If a patient fails oral anti‑emetic therapy during chemotherapy, IV anti‑emetics may be covered when medically necessary. Oral anti‑emetics not FDA‑approved as such and used adjunctively are not covered under this benefit.

IV anti‑emetics may be covered when patient fails adequate oral therapy
Oral drugs not FDA‑approved as anti‑emetics used adjunctively to chemotherapy are not covered under Part B anti‑emetic benefit

Key Definitions

Physician services — definition and criteria

Definition — Physician servicesProfessional services performed by a physician, including diagnosis, therapy, surgery, consultation, and care plan oversight; covered when the physician renders the service.

Visualization ruleA service may be considered a physician's service when the physician examines the patient in person or can visualize some aspect of the patient's condition without a third person's judgment (e.g., via x-rays, EKG, EEG, tissue samples).

Permitted locationsPhysician services are covered if provided within the United States and may be performed in a home, office, institution, or at the scene of an accident.

Physician service definition — in-person exam or visualization rule

In‑person exam or visualization ruleA service qualifies as a physician's service when the physician either examines the patient in person or is able to visualize an aspect of the patient's condition (e.g., x-ray, EKG, EEG, tissue sample) without a third person's judgment.

Example of visualizationInterpretation by a physician of an ECG or EEG transmitted electronically (not via verbal description) is a covered physician service.

Coverage requirementThe physician must render the service for it to be covered under Medicare Part B.

Adjunct and core IOL studies — definitions and differences

Core IOL studyA traditional, well‑controlled clinical investigation with full record keeping and reporting requirements.

Adjunct IOL studyAn extended distribution phase with limited safety data compiled; may be an extension of the core study or the only investigation type for that lens.

Coverage limitationAll eye care services related to an investigational IOL must be provided by the implanting investigator or practitioners under the investigator's supervision with reporting agreement; services by others related to the investigation are not covered.

Maintenance therapy (chiropractic) — definition used for coverage decisions

Maintenance therapy (chiropractic) definitionTreatment intended to prevent disease, promote health, or maintain/prevent deterioration of a chronic condition where further clinical improvement is not expected; considered supportive rather than corrective.

Coverage impactChiropractic maintenance therapy is not considered medically reasonable or necessary and is not payable by Medicare.

Claim indication guidanceSee policy §240.1.3 for how to indicate on a claim whether a treatment is maintenance or not.

Private contract — definition for opt-out agreements

Private contract definitionA written agreement between a Medicare beneficiary and a physician/practitioner who has opted out of Medicare for two years, under which the beneficiary agrees to forgo Medicare payment and pay the provider directly.

Opt-out linkagePrivate contracts are effective only when the physician/practitioner has filed a valid opt-out affidavit; the opt‑out period is two years from the affidavit date unless terminated earlier.

Effect on beneficiary rightsA beneficiary who signs a private contract may still receive services from other non‑opt‑out providers who bill Medicare.

Opt-out period / automatic renewal — standard 2-year opt-out and renewal rules

Standard opt‑out periodThe standard opt‑out period is two years from the date the affidavit is signed; affidavits filed on/after June 16, 2015 automatically renew every two years unless cancelled.

Renewal/cancellation timingA physician/practitioner must cancel automatic extension in writing at least 30 days before the next period to prevent renewal; affidavits signed before June 16, 2015 expire after two years and require timely renewal filing.

Filing requirementA valid opt‑out affidavit must be filed with all A/B MACs who have jurisdiction over claims the physician/practitioner would otherwise file with Medicare.

Opt-out — definition and requirement for private contract

Opt-out definitionAn election by a physician/practitioner to be outside Medicare for all covered items and services they furnish; requires use of private contracts for covered services and prohibits submitting Medicare claims except for emergency/urgent care.

Scope of opt-outOpt‑out applies to professional services and to items/supplies incident to those services (including lab and DMEPOS) provided by the opting physician/practitioner.

Noncovered items exceptionPrivate contracts are not required for items that are categorically not covered by Medicare (e.g., hearing aids); Medicare rules do not apply to such items.

GJ modifier — definition and usage

GJ modifier definitionThe national HCPCS modifier 'GJ' indicates emergency or urgent care services furnished by an opt‑out physician/practitioner to a beneficiary who does not have a private contract and must be included on the claim.

Denial risk for missing modifierIf the GJ modifier is not submitted on an emergency/urgent claim by an opt‑out provider, the contractor must deny the claim so the beneficiary can appeal.

Claim submission obligationOpt‑out physicians furnishing such services must submit a completed Medicare claim with appropriate HCPCS codes and modifiers on behalf of the beneficiary.

Urgent Care Services — definition and 12-hour timeframe

Urgent Care Services definitionUrgent care services are those furnished within 12 hours in order to avoid the likely onset of an emergency medical condition; care needed within a relatively short period to avoid adverse consequences.

Relation to emergency servicesUrgent care is distinct from emergency care but covered under opt‑out exceptions when provided within the 12‑hour timeframe.

Operational exampleIf a beneficiary cannot find another provider within 12 hours and needs care to avoid adverse outcomes, the situation qualifies as urgent care.

Administered — clarifies meaning relative to supervision

'Administered' clarification'Administered' refers only to the physical process by which a drug enters the patient's body and does not refer to the level of supervision during administration.

Examples of routesInjectable routes (including IV) are typical candidates for 'administered' under incident‑to provisions; oral/topical/suppositories are generally considered self‑administered.

Implication for coverageThe term distinguishes physical administration from supervisory responsibilities for payment and coverage determinations.

Administered (duplicate) — definition reiteration

Meaning reiterated'Administered' denotes the physical process by which the drug enters the patient's body and does not indicate physician supervision during the act.

Coverage noteThis clarification informs incident‑to assessments and the usual‑self‑administered determinations.

Routes presumedIV and IM routes are presumed not usually self‑administered absent evidence to the contrary.

Usually — >50% threshold definition for 'usually self-administered'

'Usually' threshold definition'Usually' means more than 50% of the time among Medicare beneficiaries using the drug; determinations are made per indication and weighted by usage across indications.

Weighted assessment processA/B MACs determine usual self‑administration separately per indication and then compute a weighted average to reach an overall determination for the drug.

Data limitations guidanceWhen reliable statistics are unavailable, CMS provides guidance for MAC consideration; but determinations must reflect actual usage patterns.

Acute condition — definition and scheduled injection course length

Acute condition definitionAn acute condition begins over a short time period, is likely short in duration, and/or has a short finite course; scheduled injections lasting less than 2 weeks are considered acute.

Relevance to self‑administrationAcute treatment courses are factored into determinations of whether a drug is usually self‑administered.

Evidence sourcesFDA approval language, package inserts, and drug compendia may support characterization as acute.

By the patient — clarifies population for self-administration determinations

'By the patient' populationRefers to Medicare beneficiaries as a collective whole; caregivers and inpatient administrations are excluded when assessing self‑administration prevalence.

Assessment scopeMACs base determinations on outpatient use among beneficiaries and ignore inpatient administrations when calculating usual self‑administration.

Exclusion of caregiversInstances where caregivers administer on behalf of beneficiaries are not counted as 'by the patient' administrations.

Unlabeled (off-label) use — definition and coverage potential when supported

Unlabeled/off‑label use definitionUse of an FDA‑approved drug for an indication not on the official FDA‑approved label; may be covered if the MAC determines the use is medically accepted based on major compendia, authoritative literature, or accepted practice.

Evidence for coverageMACs consider major compendia and peer‑reviewed medical literature; for anti‑cancer regimens, compendia or peer‑reviewed support may be requested from the treating physician.

Case‑by‑case determinationsDecisions are made by the MAC on a case‑by‑case basis taking into account compendia, literature, and accepted standards of practice.

Regimen — anti-cancer regimen definition

Regimen definitionA regimen is a combination of anti‑cancer agents clinically recognized for the treatment of a specific type of cancer.

Context for off‑label coverageOff‑label uses in an anti‑cancer regimen are evaluated with regard to regimen composition, compendia listings, and peer‑reviewed evidence.

Regimen (duplicate) — regimen definition duplicate

Regimen (duplicate)Combination of anti‑cancer agents clinically recognized for treatment of a specific cancer type; used as a unit for assessing off‑label acceptance in oncology.

Use in MAC reviewContractors may require compendia or literature to support off‑label regimen components and indications.

Medically accepted indication (by compendia) — compendia-based acceptance definition

Medically accepted indication (compendia)A use identified as Category 1 or 2A in NCCN, Class I/IIa/IIb in DrugDex, supportive narrative in AHFS‑DI or Clinical Pharmacology, or Lexi‑Drugs 'Use: Off‑Label' with Evidence Level A is considered medically accepted by compendia.

Negative compendia indicatorsA use listed as NCCN Category 3, DrugDex Class III, or narrative 'not supportive' in AHFS/Clinical Pharmacology, or Lexi‑Drugs 'Use: Unsupported' is not medically accepted.

EPO (Erythropoietin) — definition and covered uses

EPO definitionEPO is a biologically engineered protein that stimulates bone marrow to produce red blood cells; covered for treatment of anemia in chronic renal failure patients on dialysis.

Coverage settingsCovered when administered in the renal dialysis facility or self‑administered at home by a competent dialysis patient/caregiver meeting program conditions.

Non‑ESRD noteNon‑ESRD uses of EPO (e.g., chemotherapy‑induced anemia) must meet separate §50 requirements.

Home IVIG — definition and permanent payment change notice

Home IVIG definitionIntravenous immune globulin (IVIG) is an FDA‑approved pooled plasma derivative administered in the home for treatment of primary immune deficiency diseases; covered when a patient has a listed primary immunodeficiency and the physician deems home administration appropriate.

Permanent payment changeCMS established a permanent bundled payment to a DME supplier for home IVIG items and services effective for infusions on or after January 1, 2024.

Noninstitutional setting — definition for incident-to services

Noninstitutional setting definitionAll settings other than a hospital or skilled nursing facility; services furnished incident to a physician's services in these settings are subject to incident‑to rules unless covered under their own benefit category.

Implication for incident‑toDiagnostic tests and vaccines have their own benefit categories and need not meet incident‑to requirements when paid under those categories.

Homebound — two-element definition for homebound status

Homebound two‑element definitionA patient is 'homebound' when (1) due to illness/injury they need supportive devices, special transportation, or assistance to leave home, or leaving is medically contraindicated; and (2) there is a normal inability to leave home and leaving requires a considerable and taxing effort (with infrequent/short absences allowed).

Examples and allowancesInfrequent or short absences for medical treatment or special events do not negate homebound status; absences for outpatient dialysis or chemo are acceptable.

Homebound (short) — alternate homebound definition note

Homebound (short) summaryLeaving home must require considerable and taxing effort; occasional short nonmedical absences (e.g., barber) do not negate homebound status.

Clinical examplesPatients paralyzed from stroke in wheelchair, blind or senile requiring assistance, or late‑stage neurodegenerative disease are typical homebound examples.

General/Direct/Personal supervision — supervision level definitions

General supervisionPhysician overall direction not required to be physically present; physician must be available as defined by regulation.

Direct supervisionPhysician (or other supervising practitioner) must be present in the office suite and immediately available during the procedure.

Personal supervisionPhysician must be in attendance in the room during the performance of the procedure.

Audiology services — definition of audiology services

Audiology services definitionHearing and balance assessment services furnished by a qualified audiologist as legally authorized by State law; treated as 'other diagnostic tests' under section 1861(s)(3).

Scope examplesIncludes audiological/vestibular system tests, auditory processing, tinnitus assessment, and diagnostic programming of certain prosthetic devices.

Supervision exceptionAudiology services are excepted from physician supervision when personally furnished by a qualified audiologist per regulation.

Independently Practicing Psychologist (IPP) — definition and qualification

Independently Practicing Psychologist (IPP)A psychologist licensed or certified to practice in the State who renders services on their own responsibility, treats their own patients, and can bill directly and retain fees; MACs verify credentials in licensure states.

Verification sourcesMACs may use state licensing agencies, APA directory, state associations, or direct contact to verify qualifications where required.

Bone Mass Measurement (BMM) — BMM definition and scope

BMM definitionBone Mass Measurement (BMM) is a radiologic, radioisotopic, or other procedure performed to identify bone mass, detect bone loss, or determine bone quality; performed with FDA‑cleared densitometers or sonometer systems and includes physician interpretation.

Noncovered modalitiesSingle‑photon and dual‑photon absorptiometry are explicitly noncovered BMM methods.

Qualified Audiologist — qualification definition (degree/licensure/alternative pathways)

Qualified audiologist requirementsIndividual with a master's or doctoral degree in audiology and licensed where required; in non‑licensure States, alternative supervised practicum (350 hours), ≥9 months supervised full‑time experience post‑degree, and passing a national exam are required.

MAC determination roleWhen unclear, MAC determines whether qualifications are met and whether the service requires an audiologist's skills.

Diagnostic Test — definition scope

Diagnostic test scope'Diagnostic test' includes all diagnostic x‑ray tests, diagnostic laboratory tests, and other diagnostic tests furnished to a beneficiary.

Payment categorizationDiagnostic tests are governed by their own coverage requirements and supervision rules distinct from incident‑to provisions when applicable.

Treating Physician — definition used for orders and interpretation

Treating physician definitionA physician who furnishes a consultation or treats a beneficiary for a specific medical problem and uses diagnostic test results in management of that problem; radiologists performing therapeutic interventional procedures may be treating physicians.

Role in orders and interpretationTreating physician's orders and use of results are central to testing facility obligations and additional test rules.

Treating Practitioner — NPP definition for orders and treatment roles

Treating practitioner definitionA treating practitioner is an NPP (NP, CNS, or PA) who, pursuant to State law, furnishes consultation or treatment and uses diagnostic test results in management of a beneficiary's specific medical problem.

Ordering authorityTreating practitioners may order diagnostic tests within their state scope and the orders must be documented per testing facility rules.

Testing Facility — definition of facility types furnishing diagnostic tests

Testing facility definitionA testing facility is a Medicare provider or supplier that furnishes diagnostic tests and may include a physician/group, laboratory, or an independent diagnostic testing facility (IDTF).

Facility obligationsTesting facilities must follow rules for additional testing without new order, documentation, and communication with treating physician when applicable.

Order — permitted forms of an order (written, telephone, electronic) and documentation expectations

Permitted order formsAn order may be written (hand‑delivered, mailed, or faxed), telephoned, or sent electronically by the treating physician/practitioner; signatures are not required for many diagnostic test orders but intent must be documented.

Telephone order documentationIf an order is given by telephone, both the treating physician/practitioner (or office) and the testing facility must document the telephone call in their respective medical records.

Conditional ordersAn order may conditionally request an additional test if the initial test yields a certain value; testing facility must document and follow rules for performing additional tests without a new order when criteria are met.

CMS-1500	Claim form showing HCPCS codes and from/to dates of service
CMS-1450	Outpatient claim form showing HCPCS code and date of service
99241-99245	CPT consultation codes (no longer recognized by CMS for Medicare payment as of 1/1/2010)
99251-99255	CPT consultation codes (no longer recognized by CMS for Medicare payment as of 1/1/2010)
G-telehealth consultation G-codes	Inpatient telehealth consultation HCPCS G-codes (recognized)

G11.3	Diagnosis code listed for primary immune deficiency disease
D80.0	Diagnosis code listed for primary immune deficiency disease
D80.2	Diagnosis code listed for primary immune deficiency disease
D80.3	Diagnosis code listed for primary immune deficiency disease
D80.4	Diagnosis code listed for primary immune deficiency disease
D80.5	Diagnosis code listed for primary immune deficiency disease
D80.6	Diagnosis code listed for primary immune deficiency disease
D80.7	Diagnosis code listed for primary immune deficiency disease
D81.0	Diagnosis code listed for primary immune deficiency disease
D81.1	Diagnosis code listed for primary immune deficiency disease

95828	Multiple sleep latency test (narcolepsy naps) — referenced
95805	Sleep study EEG montage — referenced
95807	Polysomnogram; may be used for sleep apnea/parasomnia — referenced
95810	Polysomnogram with CPAP titration or extended — referenced
95822	Sleep study EEG with scoring — referenced
54250	Nocturnal penile tumescence testing — referenced

96102	Psychological testing by technician — referenced
96103	Psychological testing by computer — referenced
96119	Neuropsychological testing by technician — referenced
96120	Neuropsychological testing by computer — referenced

96101	Psychological test administration by technician/computer - practice expense included
96102	Psychological test administered by physician/CP (new technician/computer code referenced)
96103	Psychological test administered by physician/CP (new technician/computer code referenced)
96105	Psychological test code usable by PTs/OTs/SLPs (sometimes therapy codes)
96110	Psychological test code usable by PTs/OTs/SLPs (sometimes therapy codes)
96111	Psychological test code usable by PTs/OTs/SLPs (sometimes therapy codes)
96116	Neuropsychological test code
96118	Neuropsychological test code (tech/computer counterpart to 96119/96120)
96119	Neuropsychological test administered by physician/CP (new technician/computer code referenced)
96120	Neuropsychological test administered by physician/CP (new technician/computer code referenced)

OpenPayer

Covered Medical and Other Health Services (Chapter 15)

Coverage Criteria and Medical Necessity Rules

Relevant Codes, Modifiers, and Numeric Rules

Provider Obligations, Billing Rules, and Denial Risks

Background and Scope

Key Definitions