Healthfirst home IVIG coverage update

Medicare Part B Coverage Criteria (Chapter 15)

Covered Categories (enumeration)

Covered services under Medicare Part B include the following categories when reasonable and necessary:

Part B covered categories: Physician services (including surgery, consultation, office and institutional calls, and services and supplies furnished incident to a physician's professional service); outpatient hospital services furnished incident to physician services; outpatient diagnostic services furnished by a hospital; outpatient physical therapy, occupational therapy, and speech-language pathology services; diagnostic x-ray tests, laboratory tests, and other diagnostic tests; x-ray, radium, and radioactive isotope therapy; surgical dressings, splints, casts, and devices for reduction of fractures and dislocations; rental or purchase of durable medical equipment for use in the patient’s home; ambulance service; prosthetic devices (other than dental); braces and artificial limbs/eyes including adjustments, repairs, and replacements; certain home dialysis supplies; Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) services; Ambulatory Surgical Center (ASC) services; screening mammography, pap smears and pelvic exams, glaucoma screening, influenza, pneumococcal, hepatitis B, and COVID-19 vaccines; colorectal screening; bone mass measurements; diabetes self-management services; prostate screening; and home health visits after all covered Part A visits have been used.

See Pub. 100-02, Chap.15 §10 for enumerated list.

Date of Incurred Expense

Rules for date of incurred expense

General incurred date rule: For items and services other than surgery and childbirth, Part B expenses are incurred on the date the beneficiary received the item or service, regardless of when it was paid for or ordered.

Pub.100-02, Chap.15 §20.

Surgery and childbirth incurred date: All expenses for surgical and obstetrical care (including preoperative/prenatal and post-operative/postnatal services) billed by the surgeon/obstetrician as a package or itemized by that physician or clinic are considered incurred on the date of surgery or delivery; services by other physicians are considered incurred when performed.

Pub.100-02, Chap.15 §20.1.

Infertility Treatment

Infertility coverage

Infertility coverage: Reasonable and necessary services associated with treatment for infertility are covered under Medicare; infertility is defined as a condition sufficiently at variance with usual health to warrant treatment.

Pub.100-02, Chap.15 §20.B.

Custom-made Items Ordered but Not Furnished

Custom-made durable medical equipment ordered but not furnished

Situations allowing payment: Payment may be made based on the supplier's expenses if a custom-made item was ordered but not furnished because the beneficiary died, the order was canceled by the beneficiary, or the beneficiary's condition changed and the item was no longer reasonable and necessary; the expense is considered incurred on the date the beneficiary died or the supplier learned of the cancellation or change.

Pub.100-02, Chap.15 §20.3.A.

Determination of allowed amount: The allowed amount is based on services furnished and materials used up to the date the supplier learned of death, cancellation, or change; the appropriate A/B MAC or DME MAC determines services performed and allowable amount taking into account any salvage value; a supplier breach may preclude payment.

Pub.100-02, Chap.15 §20.3.B.

Care Plan Oversight (CPO) — Initial and ongoing

Covered when ALL of the following are met

CPO coverage criteria: 1. Beneficiary requires complex or multidisciplinary care modalities requiring ongoing physician involvement in the plan of care; 2. CPO furnished during period beneficiary receiving Medicare-covered home health agency (HHA) or hospice services; 3. Physician who bills CPO signed the home health or hospice plan of care; 4. Physician furnished at least 30 minutes of care plan oversight within the calendar month claimed (time by physician's nurse or consultations with nurse do not count); 5. Time included in discharge management codes (99238-99239, 99217) not countable toward the 30-minute threshold on same day unless separately documented after physical discharge; 6. Physician provided a covered physician service requiring a face-to-face encounter within 6 months prior to first CPO service (only E/M services qualify); 7. CPO billed is not routine post-operative care within global surgical period billed by the physician; 8. If beneficiary receiving HHA services, physician did not have significant financial/contractual interest in the HHA; hospice-employed physicians should not bill CPO; 9. The physician who bills CPO furnished the services; 10. Services provided incident to a physician's service do not qualify as CPO and do not count toward the 30-minute requirement; 11. Physician is not billing the ESRD capitation payment for same beneficiary in same month; 12. Physician must document services furnished and date and length of time in patient's record. >= 30 minutes/month

All listed conditions required for coverage per Pub.100-02, Chap.15 §F.

Concurrent Care

Covered when ALL of the following are met

Concurrent care criteria: 1. More than one physician renders services more extensive than consultative services during a period of time; 2. Each physician must play an active role in the patient's treatment because of multiple medical conditions or need for diverse specialized services; 3. A/B MAC determines whether the patient's condition warrants more than one attending physician and whether each physician's individual services are reasonable and necessary; 4. Services must not duplicate each other and must be reasonable in frequency and duration; 5. For hospital admission services by two physicians on same day, differing levels of difficulty and prior contact may justify payment to both if necessary; 6. If roles are unclear, A/B MAC should request clarification and documentation of the role each physician played.

Pub.100-02, Chap.15 §D.

Concurrent care by same specialty: Concurrent care by physicians in the same specialty or subspecialty may be covered if circumstances necessitate distinct active roles (e.g., one physician treats an unusual aspect of the specialty); otherwise uncommon.

Pub.100-02, Chap.15 §D.

Consultation billing rules

Billing guidance

Consultation billing: As of January 1, 2010, CMS no longer recognizes CPT consultation codes for Medicare payment (99241-99245 and 99251-99255) except inpatient telehealth consultation HCPCS G-codes; providers should bill appropriate new or established patient office/outpatient visit CPT codes or appropriate hospital/nursing facility care codes and follow telehealth reporting instructions.

Pub.100-02, Chap.15 §B.

Teaching physician services

Teaching physician payment conditions

Teaching physician presence: To pay a teaching physician under Part B, the teaching physician must be present during the key portion of a service rendered by a resident; if a resident conducts a visit without teaching physician presence, the teaching physician must repeat key portions and document them. Medical record must contain signed or countersigned notes showing physician review and visits at critical times.

Pub.100-02, Chap.15 §30.2.

Payment for custom-made items not furnished

Payment for incomplete custom items

Allowed payment circumstances: If a custom-made item was ordered but not furnished because beneficiary died, canceled the order, or the beneficiary's condition changed making the item no longer reasonable and necessary, payment can be made based on the supplier's expenses incurred up to the date the supplier learned of the death/cancellation/change; the A/B MAC or DME MAC determines the allowable amount considering services performed, materials used, and salvage value; supplier breach may preclude payment.

Pub.100-02, Chap.15 §20.3.

Coverage for Interns and Residents

Services furnished by interns and residents are covered according to where and how training costs are borne and program scope:

Provider services within approved training program: Medical and surgical services furnished by interns and residents within the scope of an approved training program are covered as provider services where the hospital or provider incurs all or substantially all training costs; where the provider does not incur such costs and services are performed by a licensed physician, services are payable under Part B by the A/B MAC.

Pub.100-02, Chap.15 §A.

Moonlighting Coverage Criteria

Moonlighting (services outside scope of training) covered as physician services when ALL criteria below are met:

Moonlighting physician service criteria: (1) Services are identifiable physician services requiring in-person physician performance and contributing to diagnosis or treatment; (2) Intern/resident is fully licensed to practice in the state where services are performed; (3) Services can be separately identified from those required by the training program. When met, services are considered furnished as physician services rather than intern/resident services.

Pub.100-02, Chap.15 §B.

Optometry and IOL Study Coverage

Optometrist and IOL investigational study coverage rules:

Optometrist coverage: A doctor of optometry is considered a physician for services they are authorized to perform under State law; services must be medically reasonable and necessary and meet applicable coverage requirements.

Pub.100-02, Chap.15 §30.4.

IOL FDA-monitored study rule: All eye care services related to an FDA-monitored intraocular lens (IOL) investigation must be provided by the investigator (implanting ophthalmologist) or a practitioner who provides services under the investigator's direction or supervision and who has an agreement to report patient information to the investigator; services furnished by others during the investigation are not covered unless unrelated to the investigation.

Pub.100-02, Chap.15 §30.4.A.

Chiropractic Coverage and Exclusions

Chiropractic coverage limits:

Chiropractic covered service: Coverage extends only to treatment by manual manipulation of the spine to correct a subluxation when legal in the State; other services furnished or ordered by chiropractors (including most diagnostic or therapeutic services) are not covered and there is no separate payment for manual devices used in manipulation.

Pub.100-02, Chap.15 §30.5.

Maintenance therapy exclusion: Chiropractic maintenance therapy—treatment intended to prevent disease, promote health, prolong quality of life, or maintain/prevent deterioration when further clinical improvement cannot reasonably be expected—is not medically reasonable or necessary and is not payable.

Pub.100-02, Chap.15 §30.5.B.

Opt-Out / Private Contract Rules

Opt-out and private contract coverage stance:

Opt-out effect: Physicians/practitioners who opt out are not required to submit claims and are excluded from Medicare limits on charges; services furnished under valid private contracts are not covered services and no Medicare payment will be made for such services.

Pub.100-02, Chap.15 §40 and §40.2.

ABN vs opt-out: Non-opt-out providers must submit claims or use an Advance Beneficiary Notice (ABN) when appropriate; opt-out physicians must not use ABNs and must use private contracts meeting §40.8 requirements; affidavits filed on/after 2015-06-16 automatically renew every 2 years unless cancelled per rules.

Pub.100-02, Chap.15 §40.2 and §40.8.

IHS Part B Billing

Indian Health Service (IHS) billing allowances:

IHS billing eligibility: Section 1880 provides exceptions allowing certain Indian Health Service and tribally operated outpatient facilities to bill Medicare for Part B services; a specified list of Part B items and services may be billed during a defined 5-year period beginning January 1, 2005 (including DME, prosthetics/orthotics, drugs, clinical lab services, ambulance services, and screening/preventive services not already covered).

Pub.100-02, Chap.15 §30.6 and §30.6.1.

Opt-Out Effect and Private Contract Requirements

Covered (i.e., allowed) when ALL of the following are met:

Valid Opt-Out Affidavit: Physician/practitioner has a valid opt-out affidavit filed with relevant MAC(s) that meets §40.9 requirements (written, signed, contains identifying information, acknowledges private-contract-only treatment except emergency/urgent care, and other specified elements); affidavits signed on or after 2015-06-16 automatically renew every 2 years unless cancelled in writing at least 30 days before the next opt-out period.affidavit filed; contains required elements

Pub.100-02, Chap.15 §40.9 and §40.2.

Private Contract in Place: A written private contract meeting §40.8 requirements is signed by beneficiary (or legal representative) and physician/practitioner and provided to the beneficiary prior to services; provider must retain original signed contracts for the duration of each 2-year opt-out period and make them available to CMS upon request.contract signed and provided pre-service

Pub.100-02, Chap.15 §40.8 and §40.6.

Exceptions and Payments to Beneficiary

Medicare payment to beneficiary may occur under specific conditions (ANY of the following):

Emergency/Urgent Care Without Private Contract: Emergency or urgent care services furnished by an opt-out physician/practitioner to a beneficiary with whom the provider has not signed a private contract may be billed and paid under emergency/urgent care rules; provider must submit claim with appropriate modifier and may not charge more than the Medicare limiting charge or applicable assignment rules.emergency/urgent care

Pub.100-02, Chap.15 §40.5 and §40.28.

Provider Failed to Contract: If an opt-out physician/practitioner failed to privately contract for non-emergency/urgent services furnished, beneficiary-submitted claims may be paid if the MAC determines no private contract existed and timelines are met (e.g., services furnished no later than 15 days after MAC notice); if provider fails to respond to MAC's request within 45 days, MAC may pay beneficiary based on nonparticipating rates and follow §40.11 procedures.no private contract; notice timelines

Pub.100-02, Chap.15 §40.6 and §40.11.

Failure to Properly Opt-Out or Maintain Opt-Out

When ANY listed failures occur, the following consequences apply

Failures Defined: Failing to file required affidavit(s) or filing private contracts prior to affidavit, submitting claims or receiving Medicare payment during opt-out, failing to enter or retain valid private contracts, failing to comply with emergency/urgent billing rules, or other failures defined in §40.10–§40.11 constitute failure to properly opt out or to maintain opt-out.any listed failure

Pub.100-02, Chap.15 §40.10–§40.11.

Consequences include nullification of attempted opt-out and private contracts, requirement to submit claims to Medicare for covered services, application of limiting charge provisions (115% for nonparticipating physicians where applicable), prohibition on billing or collecting from beneficiary except deductible/coinsurance, and potential denial of payment; provider has 45 days to demonstrate good faith after contractor notice before effects apply.nullification effective per notice timelines

Pub.100-02, Chap.15 §40.10–§40.11.

Opt-out applicability, contractor actions, and recordkeeping

Covered/operative rules and conditions

Opt-out scope and effect: An opt-out applies to all Medicare-covered items and services furnished by that physician/practitioner; private contracts must meet §40.8 requirements; suppliers (DMEPOS, labs, IDTFs) cannot opt out; opt-out providers may not submit claims for covered services except emergency/urgent care provided to beneficiaries without a private contract.

Pub.100-02, Chap.15 §40.2, §40.18.

Participating to Opt-Out timing: Participating physicians must file affidavit at least 30 days before the next calendar quarter to have opt-out effective on that quarter start; affidavits effective on/after 2015-06-16 auto-renew every 2 years unless cancelled in writing at least 30 days prior to next period.30 days

Pub.100-02, Chap.15 §40.2 and §40.14.

Failure-to-maintain response: When contractor identifies potential failure to maintain opt-out, it must notify the physician, request explanation and resolution within 45 days, and may hold claims in suspense until response; if no satisfactory response, apply §40.11 consequences.

Opt-out physician/practitioner coverage criteria

Covered only in limited circumstances (emergency or urgent care) and subject to conditions:

Emergency/Urgent Care Coverage: Services furnished by an opt-out physician/practitioner to a beneficiary with whom the provider has not signed a private contract in an emergency or urgent care situation are covered; the opt-out provider must submit a Medicare claim using the appropriate HCPCS modifier (e.g., GJ) and may charge no more than the Medicare limiting charge or applicable assignment rules.

Pub.100-02, Chap.15 §40.28 and §40.31.

When NOT covered: Services furnished by an opt-out physician/practitioner under a private contract are not payable by Medicare and claims must be denied; follow-up non-urgent care after emergency/urgent visit requires a private contract for further treatment to be noncovered.

Pub.100-02, Chap.15 §40.28 and §40.94.

Post-emergency follow-up: Once beneficiary no longer needs emergency/urgent care, follow-up care is not payable by Medicare unless a private contract was not entered; provider must ask beneficiary to sign a private contract for non-urgent follow-up or refer to Medicare provider for further care billed appropriately.

Outpatient drugs and biologicals coverage

Outpatient drugs/biologicals are covered only if ALL of the following are met:

General drug coverage conditions: Drugs and biologicals must meet the statutory definition and appear in the recognized compendia or be approved for inclusion; be of a type not usually self-administered (unless statutory exception applies); meet incident-to requirements if applicable; be reasonable and necessary for diagnosis or treatment; not be excluded as noncovered immunizations; and not be determined by FDA to be less than effective.

Pub.100-02, Chap.15 §50 and §50.1.

Incident-to coverage

Covered under 'incident to' when ALL of the following are met

Incident-to coverage requirements: Drug/biological must be of a form not usually self-administered; must be furnished by a physician; must be administered by the physician or auxiliary personnel under the physician's personal supervision; and the drug charge must be included on the physician's bill and represent an expense to the physician.

Pub.100-02, Chap.15 §50.3 and §50.126.

Determination of 'usually self-administered'

A drug is considered 'usually self-administered' when the following logic applies

Usual self-administration determination: For each indication determine whether the drug is self-administered (>50% of Medicare beneficiaries for that indication); compute a weighted average across indications to make an overall determination; absent evidence, presume IV and IM drugs are not usually self-administered and SC drugs are usually self-administered, with MACs considering factors such as acute vs chronic condition and frequency of administration.>50%

Pub.100-02, Chap.15 §50.2 and §50.109–113.

Drugs treated as hospital outpatient supplies

Exceptions where usually self‑administered drugs may be covered as hospital outpatient supplies

Drugs treated as supplies: Drugs that are integral to a procedure or directly related to it (e.g., preoperative sedatives, ophthalmic drops given immediately before/during/after ophthalmic procedures, contrast media integral to imaging, topical solution for photodynamic therapy at hospital, antibiotic ointments placed at completion of procedure) may be treated as hospital outpatient supplies and billed under Part B as packaged supply costs.

Pub.100-02, Chap.15 §50.4.M.

Incident-to and Reasonable & Necessary Coverage

Covered when ALL of the following are met:

Incident-to and R&N coverage: Drug/biological is not usually self-administered; furnished by a physician; administered by the physician or auxiliary personnel under the physician's personal supervision; charge included in physician's bill and is an expense to physician; drug use is FDA-approved for the indication (or MAC determines medically accepted for off-label/compendia-supported uses); and drug is reasonable and necessary for the individual patient.

Pub.100-02, Chap.15 §50.3 and §50.4.1–129.

Unlabeled use allowance: Unlabeled (off-label) uses may be covered if the MAC determines the use is medically accepted based on major drug compendia or peer-reviewed literature; contractors may request supporting documentation from treating physicians.

Pub.100-02, Chap.15 §50.4.1 and §50.4.5.

Examples of Not Reasonable and Necessary

Medications NOT reasonable and necessary in the following categories:

Not for particular illness: Medications given for general good or welfare (e.g., vitamins) or not accepted therapies for a particular illness are excluded.

Pub.100-02, Chap.15 §50.4.3.1.

Injection method not indicated: Parenteral administration is not covered when oral administration is effective and preferred unless special medical circumstances justify injections; entire charge excluded when inappropriate.

Pub.100-02, Chap.15 §50.4.3.2.

Excessive medications: Medications exceeding accepted frequency or duration (e.g., more-than-monthly B12 injections) are not covered absent special medical circumstances.

Pub.100-02, Chap.15 §50.4.3.3.

Antigens

Covered when ALL of the following are met:

Physician-prepared antigens: Antigens prepared for a particular patient are payable if prepared by an MD/DO who examined the patient and determined a treatment plan and dosage; antigens must be administered per plan by an MD/DO or properly instructed person under physician supervision; reasonable supply is not more than a 12‑month supply prepared for the patient at any one time.<= 12 months supply

Pub.100-02, Chap.15 §50.4.4.1.

Pneumococcal Vaccine Coverage

Coverage per CMS aligned with ACIP when criteria below are met:

Pneumococcal vaccine coverage: Adults ≥65 and adults 19–64 with specified risk factors who have not previously received PCV (or history unknown) should receive 1 dose of PCV (PCV20 or PCV15); when PCV15 is used it should be followed by PPSV23 per interval guidance (PCV15→PPSV23 ≥1 year; minimum 8 weeks for certain immunocompromised/cochlear implant/CSF leak cases); prior vaccine history may be based on patient verbal history; no physician order required for coverage.intervals per ACIP guidance

Pub.100-02, Chap.15 §50.4.4.2.

Hepatitis B Vaccine Coverage

Covered for Medicare beneficiaries at high or intermediate risk when criteria met:

Hepatitis B vaccine coverage: Hepatitis B vaccine and administration are covered for beneficiaries in listed high- or intermediate-risk groups (e.g., ESRD patients, hemophiliacs receiving factor concentrates, household contacts of HBV carriers, persons with diabetes, certain healthcare workers) unless laboratory evidence indicates immunity; separate administration charge recognized for ESRD patients.

Pub.100-02, Chap.15 §50.4.4.2.B.

Influenza Vaccine Coverage

Covered when:

Influenza vaccine and its administration are covered when furnished in compliance with applicable State law by any provider or entity with a supplier number; typically administered once per flu season; no physician order required for coverage.

Pub.100-02, Chap.15 §50.4.4.2.C.

COVID-19 Vaccine Coverage and In-Home Administration Payment

Covered and additional payment possible when:

COVID-19 and related vaccine coverage: COVID-19 vaccines and their administration are covered under Part B when furnished in compliance with State law by any provider or entity with a supplier number; effective dates and payment rates published by CMS.

Pub.100-02, Chap.15 §50.4.4.2.D.

In‑home vaccine additional payment: An additional Part B payment for in‑home administration of pneumococcal, influenza, hepatitis B, or COVID‑19 vaccines may be made if the patient has difficulty leaving home or faces barriers to getting vaccinated outside the home, the sole purpose of the visit is vaccine administration, the home is not an institution, and the furnisher documents the patient's clinical status or barriers; only one additional payment per patient per home visit and no additional payment if another Medicare-covered service was provided in same home on same date.one additional payment per home visit

Pub.100-02, Chap.15 §50.4.4.2 and §50.4.4.2.3.

Additional in‑home preventive vaccine administration payment

Additional payment made if ALL of the following circumstance-based conditions are met (summary):

In‑home preventive vaccine payment conditions: 1. Patient has difficulty leaving home or faces barriers to getting vaccines outside the home (examples: needs supportive device or caregiver assistance, more susceptible to disease, generally unable to leave home or leaving requires considerable and taxing effort, or is hard-to-reach due to disability, socioeconomic, or geographic barriers); 2. The sole purpose of the visit is to administer one or more preventive vaccines; 3. The home is not an institution as defined by statute/regulation; 4. Furnisher documents in patient's medical record the clinical status or barriers; and 5. Only one additional payment allowed per patient per home visit and not allowed if another Medicare-covered service was furnished in same home on same date.

Pub.100-02, Chap.15 §50.4.4.2.3 and §50.4.4.2.3.3.

Off‑label use of FDA‑approved drugs in anti‑cancer chemotherapeutic regimens

Off‑label, medically accepted indications are covered when supported by compendia or peer‑reviewed literature under defined conditions:

Sources for medically accepted off‑label uses: An off‑label use is considered medically accepted if supported in one or more listed compendia (e.g., AHFS‑DI, NCCN, DrugDex, Clinical Pharmacology, Lexi‑Drugs with specified acceptance criteria) or by peer‑reviewed medical literature from recognized journals; contractors may use compendia subscriptions and may request supporting documentation from treating physicians.

Pub.100-02, Chap.15 §50.4.5.

Denial for compounded drugs produced in violation of FFDCA

Medicare does not pay for compounded drugs produced in violation of the Federal Food, Drug, and Cosmetic Act:

Denial conditions for compounded drugs: If FDA determines a firm is producing compounded drugs in violation of the FFDCA (e.g., mass production beyond pharmacy practice, operating as an unapproved manufacturer, producing drugs without approved NDA, misbranded or adulterated), Medicare will not pay for those drugs and will not pay for DME or prosthetic devices used to administer such drugs; A/B MACs act when notified by CMS.

Pub.100-02, Chap.15 §50.4.7.

Part B coverage criteria for immunosuppressive drugs

Immunosuppressive drugs are covered under Part B when meeting one of the enumerated conditions:

Covered immunosuppressive drugs: 1) Drug FDA‑approved with labeling indication for preventing or treating transplant rejection; OR 2) Drug FDA‑approved and determined by the DME MAC to be reasonable and necessary for preventing or treating rejection for a specific claim (MAC may consider compendia and literature); OR 3) Compounded formulation derived only from a drug described in (1) or (2) that is orally or enterally administered. Drugs covered irrespective of self-administration; antibiotics, hypertensives, and other drugs not directly related to rejection are excluded.

Pub.100-02, Chap.15 §50.5.1.

Immunosuppressive Drugs

Covered immunosuppressive drugs when ANY of the following are met:

Immunosuppressive drug coverage: 1) FDA‑approved drug with labeling indication for preventing/treating transplant rejection; 2) FDA‑approved drug determined by DME MAC to be reasonable and necessary for preventing/treating rejection; 3) Compounded oral/enteral formulation derived only from a drug in (1) or (2).

Pub.100-02, Chap.15 §50.5.1.

Erythropoietin (EPO) Home Use

Erythropoietin (EPO) for dialysis patients using EPO in the home is covered when ALL of the following are met:

Home EPO coverage: 1. A current comprehensive care plan for monitoring home EPO use is in place; 2. Patient is a dialysis patient; 3. Preselection monitoring (hematocrit/hemoglobin, iron studies) documented; 4. Hematocrit thresholds met (initiating ≤30%, continuing between 30%–36% unless exceptions documented); 5. Patient under care of responsible physician and renal dialysis facility; 6. Patient or caregiver trained and capable of injecting and aseptic technique; 7. Adequate refrigerated storage at home; 8. Physician/facility responsibilities fulfilled (protocol following label, supply limited to 2 months on hand, records maintained); 9. ESRD facility submits claims if facility provides EPO and required data elements included on claims.Hct initiating <=30%; continuing 30–36%

Pub.100-02, Chap.15 §50.5.2.1.

Oral Anti-Cancer Drugs

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

Oral anti-cancer coverage: Prescribed by an authorized practitioner; FDA‑approved; have the same active ingredients as a covered non-self‑administrable anti‑cancer drug and are used for the same indications (including unlabeled uses) as the non-self‑administrable version; and reasonable and necessary for the individual patient.

Pub.100-02, Chap.15 §A3-3112.4.B.5.

Oral Anti-Emetic Drugs

Oral anti-emetic drugs used as full replacement for IV anti-emetics in a chemotherapy regimen are covered when ALL of the following are met:

Oral anti-emetic coverage: Drug FDA‑approved as an anti‑emetic; administered by the treating physician or per written order as part of a chemotherapy regimen; initiated within 2 hours of chemotherapy administration and continued no more than 48 hours; used as a full therapeutic replacement for the IV anti‑emetic that would otherwise be administered.Initiation within 2 hours; duration ≤48 hours

Pub.100-02, Chap.15 §50.5.4.

Hemophilia Clotting Factors

Hemophilia clotting factors are covered when ALL of the following are met:

Hemophilia clotting factor coverage: Patient has diagnosis of Factor VIII deficiency, Factor IX deficiency, or Von Willebrand's disease; patient is competent to use factors without medical supervision; amount on hand is based on a historical utilization profile developed by the contractor and treating source; extraordinary events and changes in medical needs are considered for adjustments.

Pub.100-02, Chap.15 §50.5.5.

Home Intravenous Immune Globulin (IVIG)

Home IVIG is covered when ALL of the following are met:

Home IVIG coverage: Patient has a diagnosed primary immune deficiency disease (listed ICD-10 codes); IVIG is an approved pooled plasma derivative; administered in the patient's home; and the physician determines home administration is medically appropriate. CMS established a permanent bundled payment for home IVIG items and services effective 01-01-2024 to be paid to a DME supplier; pump may or may not be included and is not covered under the bundled payment.

Pub.100-02, Chap.15 §50.6.

Incident-to coverage criteria

Services and supplies furnished 'incident to' a physician's professional service are covered when ALL of the following are met:

Incident-to core requirements: Services/supplies are integral and incidental to the physician's professional service; commonly rendered without charge or included in the physician's bill; of a type commonly furnished in physician offices/clinics; furnished by the physician or auxiliary personnel under the physician's direct supervision; and represent an expense to the physician or legal entity billing for the services/supplies.

Pub.100-02, Chap.15 §60.1, §60.2 and §50.3.

Nonphysician practitioner incident-to criteria

For nonphysician practitioners to have services covered as 'incident to' a physician's service, ALL must be met:

Nonphysician practitioner incident-to requirements: Service must meet all incident-to requirements; be performed under direct supervision; there must have been an initiating direct physician service and subsequent physician involvement reflecting active management of the course of treatment; and the physician must be physically present in the same office suite and immediately available.

Pub.100-02, Chap.15 §60.2–60.3.

Homebound/general supervision criteria

Exception for homebound patients in medically underserved areas — covered when ALL of the following are met:

Homebound exception (general supervision): Patient is homebound; service is integral part of the physician's service and performed under general physician supervision by employees of the physician/clinic; services included in physician/clinic bill and represent an expense to them; services are reasonable and necessary and not otherwise available from a participating Home Health Agency in a timely manner. General supervision permits physician not to be physically present at patient's residence but requires overall supervision and contact procedures.

Pub.100-02, Chap.15 §60.4 and §60.4.1–60.4.3.

Home IVIG coverage

Home IVIG coverage and payment rules:

Home IVIG coverage criteria: Patient has a diagnosed primary immune deficiency disease; IVIG is an approved pooled plasma derivative; administered in the patient's home; physician determines home administration is medically appropriate. Permanent bundled payment for home IVIG items and services effective 01-01-2024 is paid to a DME supplier; pump is not covered under the bundle.

Pub.100-02, Chap.15 §50.6 and §50.6 (DIV FF Sec.4134).

Homebound Criteria (Criteria-Two and allowable absences)

Covered when BOTH of the following Criteria-Two conditions are met (patient must also meet one Criteria-One condition):

Criteria-Two: (1) There must exist a normal inability to leave home; AND (2) Leaving home must require a considerable and taxing effort. If patient meets one Criteria-One condition (e.g., needs supportive devices or leaving home medically contraindicated), Criteria-Two must also be satisfied.

See Pub.100-02, Chap.15 §60.4.1 Criteria-Two.

Allowed absences: Absences for receiving health care treatment (e.g., adult day centers for medical care, outpatient dialysis, outpatient chemotherapy/radiation) or infrequent/short nonmedical absences (religious services, brief drives) do not negate homebound status.

Pub.100-02, Chap.15 §60.4.1 and examples.

Sleep Disorder Clinic Diagnostic Coverage

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

Sleep clinic diagnostic coverage: (1) Clinic is hospital-affiliated or under physician direction/control; (2) Patients are referred by their attending physicians and clinic retains attending physician orders; (3) Need for diagnostic testing is confirmed by medical evidence (physician exam, lab tests). Diagnostic testing duplicative of recent pertinent testing is not covered.

Pub.100-02, Chap.15 §70 and §70.3.A–C.

Covered indications: Testing covered only for patients with symptoms/complaints of listed conditions (e.g., narcolepsy, sleep apnea, impotence under limited circumstances, parasomnias); ordinarily limited numbers of nights/naps apply and additional sessions require persuasive medical justification.

Pub.100-02, Chap.15 §70.3.B and §70.3.B.1–4 with codes 95828, 95805, 95807, 95810, 95822, 54250.

Not covered: Polysomnography for chronic insomnia is not covered as it is not reasonable and necessary based on current evidence.

Pub.100-02, Chap.15 §70.3.C.

Supervision Requirements for Diagnostic Tests

Diagnostic tests payable under the physician fee schedule must be furnished under appropriate physician supervision levels as defined:

Supervision definitions: General: procedure furnished under physician's overall direction (physician need not be present); Direct: physician present in office suite and immediately available; Personal: physician in attendance in the room. Numeric supervision levels are assigned per MPFS database and apply to CPT/HCPCS codes.

Pub.100-02, Chap.15 §80 and 42 CFR 410.32(b).

Practitioner exceptions: Nurse practitioners, clinical nurse specialists, physician assistants, and CRNAs may perform diagnostic tests under their scope of practice and state law; when they personally perform tests under §1861(s)(2)(K), the diagnostic test supervision policy under §1861(s)(3) does not apply; services furnished without required supervision are not reasonable and necessary.

Pub.100-02, Chap.15 §80.

Laboratory Services and Home Specimen Collection

Clinical laboratory services are covered when reasonable and necessary, ordered/used promptly, meet CLIA, and when home pickup is medically necessary:

Laboratory coverage: (1) Lab services must meet CLIA requirements; (2) Ordered and used promptly by treating physician or qualified NPP; (3) Tests must be reasonable and necessary under §1862(a)(1)(A).

Pub.100-02, Chap.15 §80.1.

Home specimen pickup: Independent laboratory home visit to obtain specimens is covered if patient is confined to home (homebound) and specimen collection requires the skills of a laboratory technician; specimen types requiring only a messenger (e.g., urine or sputum) are not medically necessary for a technician visit.

Pub.100-02, Chap.15 §80.1.3 and §80.1.3.1.

Independent laboratory home visit

Covered when ALL of the following are met

Homebound specimen collection criteria: Patient is confined to the home or place of residence used as home (homebound); specimen collection requires skills of a laboratory technician (not just messenger pickup).

Pub.100-02, Chap.15 §80.1.3 and §80.1.3.1.

Independent laboratory visit to institution

Covered when ALL of the following are met

Institutional visit criteria: (a) Patient was confined to the facility; and (b) The facility did not have on-duty personnel qualified to perform venipuncture. Applies to independent laboratories visiting institutions other than hospitals.

Pub.100-02, Chap.15 §80.1.3.2.

Audiology diagnostic test coverage

Covered when ANY of the following clinical reasons apply and a physician (or applicable NPP) orders testing for diagnostic evaluation or treatment planning

Reasons for audiology testing: Evaluation of suspected change in hearing/tinnitus/balance; evaluation of cause of hearing/balance disorder; determination of effect of medication/surgery/treatment; reevaluation for progressive or fluctuating conditions; failure of a screening test; diagnostic analysis/programming of cochlear or brainstem implants; testing before and after auditory prosthetic implantation; testing must be ordered by a physician or applicable NPP.

Pub.100-02, Chap.15 §80.3 and §80.3.C.

Who may perform and bill psychological/neuropsychological tests

Covered when performed by authorized provider types under supervision rules

Authorized billers: Diagnostic psychological and neuropsychological tests may be performed and billed by clinical psychologists (CPs), independently practicing psychologists (IPPs), qualified NPs, CNSs, PAs, and qualified technicians as permitted by state scope-of-practice and supervision rules; certain tests and technician/computer codes have site-of-service payment differentials and billing restrictions.

Pub.100-02, Chap.15 §80.2 and §80.2 Payment/Billing guidelines.

Beneficiaries Who May be Covered (BMM)

Covered when at least ONE of the following conditions is met and other general coverage rules apply:

BMM coverage criteria: 1) Woman determined by treating clinician to be estrogen-deficient and at clinical risk for osteoporosis; 2) Individual with vertebral abnormalities on x-ray indicative of osteoporosis/osteopenia/vertebral fracture; 3) Individual receiving or expected to receive glucocorticoid therapy equivalent to an average of ≥5.0 mg prednisone per day for >3 months; 4) Individual with primary hyperparathyroidism; 5) Individual being monitored to assess response to or efficacy of an FDA-approved osteoporosis drug therapy.at least one condition

Pub.100-02, Chap.15 §80.5.4 and §80.5.6.

Conditions for Coverage and Modality

Additional required conditions for covered BMMs:

BMM modality and supervision: Must be ordered by the treating physician or qualified nonphysician practitioner after evaluation; performed under appropriate physician supervision per 42 CFR 410.32(b); include physician interpretation; when monitoring osteoporosis drug therapy or confirming baseline, BMM must be performed with dual-energy x-ray absorptiometry of axial skeleton.

Pub.100-02, Chap.15 §80.5.4.

Covered Indications for BMM

Covered when ANY one of the following conditions is met:

BMM coverage indications: 1) Woman determined to be estrogen-deficient and at clinical risk for osteoporosis; 2) Individual with vertebral abnormalities on x-ray indicative of osteoporosis/osteopenia/vertebral fracture; 3) Individual receiving or expected to receive glucocorticoid therapy equivalent to ≥5.0 mg prednisone/day averaged over >3 months; 4) Individual with primary hyperparathyroidism; 5) Individual being monitored to assess response to or efficacy of an FDA-approved osteoporosis drug therapy.

Pub.100-02, Chap.15 §80.5.6.

Facility Furnishing Additional Tests

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

Testing facility additional test criteria: 1) The testing facility performs the originally ordered diagnostic test; 2) The interpreting physician documents that because of an abnormal result an additional diagnostic test is medically necessary; 3) Delaying the additional test would adversely affect beneficiary care; 4) The result of the additional test is communicated to and used by the treating physician/practitioner in treatment; 5) The interpreting physician documents in the report why additional testing was done and the facility documents attempts to reach the treating physician if applicable.

Pub.100-02, Chap.15 §80.6.3.

Membership dues, subscription fees, service contract charges and similar payments that entitle enrollees to services, repairs, replacements, or reduced‑cost items are not considered expenses incurred for Medicare Part B covered items or services and are not payable under Part B. Examples include ambulance memberships, insurance for replacement of prosthetic lenses, and service contracts for durable medical equipment.

Separate charges for completion of claim forms—such as charges for completing Form CMS‑1500, a statement in lieu, or an itemized bill—are not covered. Payment for completing the CMS‑1500 is considered included in the physician fee schedule amount and should not be billed separately.

Care Plan Oversight (CPO) services are not covered for patients who are residents of skilled nursing facilities, nursing home facilities, or hospitals. CPO applies only to beneficiaries under home health agency or hospice care and must meet the specific CPO coverage requirements to be payable.

A physician who is employed by a hospice, including a volunteer medical director, should not bill separately for Care Plan Oversight; payment for services of a physician employed by the hospice is included in the hospice payment and therefore not payable as separate CPO.

Medicare coverage for chiropractic services is limited to manual spinal manipulation to correct a demonstrable subluxation and only where state law authorizes the chiropractor to perform that service. All other services furnished or ordered by chiropractors are not covered, and chiropractic maintenance therapy—treatments intended to maintain or prevent deterioration when further clinical improvement is not expected—is explicitly not payable.

During FDA‑monitored investigations of intraocular lenses (IOLs), all eye care services related to the investigation must be provided by the investigator (the implanting ophthalmologist) or by practitioners furnishing services under the investigator’s direction or supervision and who have an agreement to report patient data to the investigator. Eye care services furnished by others during the investigational period are not covered unless they are unrelated to the investigation.

Provider Actions, Billing and Documentation Requirements

Billing Rule

Payment rules for custom-made items ordered but not furnished

If a custom-made item was ordered but not furnished due to the beneficiary's death, cancellation by the beneficiary, or a change in medical necessity, payment may be made based on the supplier's documented expenses (supplier invoice). The date of incurred expense is the date the supplier learned of the death, cancellation, or change in necessity. The MAC or DME MAC determines allowable amounts, considering services performed, materials used up to that date, and any salvage value. Payment to the supplier is permitted when the beneficiary cancelled for reasons other than death or condition change; if the supplier breached the agreement (e.g., failed to deliver within contract time without excuse), payment may be denied.

Expense considered incurred on date supplier learned of death/cancellation/changed condition
Allowed amount = services and materials used up to that date, minus salvage value where appropriate
Payment to supplier only if beneficiary cancelled for non‑death/non‑condition reasons
Supplier breach (unexcused failure to deliver) can trigger denial

Coding, Codes and Key Numeric Thresholds

Claim forms and HCPCS usagemixed

HCPCS	Referenced for reporting allergist services on claims (HCPCS codes and from/to dates or date of service).
Form CMS-1500	Claim form for professional services showing HCPCS codes and from/to dates of service.
Form CMS-1450	Outpatient claim form showing HCPCS code and date of service.

Referenced CPT/HCPCS codesmixed

G-codes (inpatient telehealth consultation)	HCPCS G-codes for inpatient telehealth consultation referenced as still recognized
99241-99245	CPT consultation codes referenced as no longer recognized for Medicare
99251-99255	CPT consultation codes referenced as no longer recognized for Medicare
99238-99239	Hospital discharge day management codes referenced as not countable toward CPO time if on same discharge day unless separately documented after physical discharge
99217	Discharge from observation code referenced similarly for CPO

IHS billable Part B services (per document list)mixed

Durable medical equipment	Listed as Part B services IHS facilities may bill for during the specified 5-year period
Prosthetics and orthotics	Listed as Part B services IHS facilities may bill for during the specified 5-year period
Prosthetics devices	Listed as Part B services IHS facilities may bill for during the specified 5-year period
Therapeutic shoes	Listed as Part B services IHS facilities may bill for during the specified 5-year period
Surgical dressings and splint casts	Listed as Part B services IHS facilities may bill for during the specified 5-year period
Drugs	Listed as Part B services IHS facilities may bill for during the specified 5-year period
Clinical laboratory services	Listed as Part B services IHS facilities may bill for during the specified 5-year period
Ambulance services	Listed as Part B services IHS facilities may bill for during the specified 5-year period

Opt-out emergency/urgent modifiersHCPCS

GJ	Opt-out physician/practitioner EMERGENCY OR URGENT SERVICES
54	Surgical Care Only modifier (example used with GJ to bill setting of fractured leg)
post op only modifier	Used by a Medicare physician/practitioner to bill post-op care in the global period (described in example)

Denial/remark codes for opt-out claimsmixed

Claim Adjustment Reason Code 27	Expenses incurred after coverage terminated (used at claim level with group code PR and remark code MA47)
MA47	Remittance advice remark code indicating provider opted out; patient responsible for payment
MA47 N771	Remittance advice remark code for knowingly and willfully submitted claims by opt-out provider with alert about limiting charge

Covered ICD-10 Diagnosis Codes for home IVIG (listed examples)ICD-10Covered

G11.3	Inherited ataxia (example ICD-10-CM code listed)
D80.0	Hereditary hypogammaglobulinemia
D80.2	Selective deficiency of immunoglobulin A
D80.3	Selective deficiency of immunoglobulin G
D80.4	Selective deficiency of immunoglobulin M
D80.5	Immunodeficiency with predominantly antibody defects
D80.6	Immunodeficiency with increased IgM
D80.7	Immunodeficiency with defects in B-cell maturation
D80.8	Other immunodeficiencies with predominantly antibody defects
D80.9	Immunodeficiency, unspecified

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Example ICD-10 codes for primary immunodeficiency conditions referencedICD-10

D81.1
D81.2
D81.5
D81.6
D81.7
D81.82
D81.89
D81.9
D82.0
D82.1

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Sleep study and related diagnostic codesCPT

95828	Sleep nap study (used for narcolepsy)
95805	Multiple sleep latency test (MSLT) — associated code referenced for narcolepsy
95807	Polysomnography with sleep staging
95810	Polysomnography with CPAP titration or split-night study
95822	Polysomnography for diagnostic classification (EEG/extended monitoring)
54250	Nocturnal penile tumescence testing

Covered CPT Codes (psychological & neuropsychological)CPTCovered

96101	Psychological test administered by computer or technician (see doc)
96102	Psychological test or neuropsychological test administered by physician/CP? (new tests) -- technician/computer codes referenced
96103	Psychological test administered by technician/computer (listed)
96105	Psychological test (may be performed by PT/OT/SLP as sometimes therapy)
96110	Psychological test (may be performed by PT/OT/SLP as sometimes therapy)
96111	Psychological test (may be performed by PT/OT/SLP as sometimes therapy)
96116	Neuropsychological test
96118	Neuropsychological test (technician/computer counterpart noted)
96119	Neuropsychological test administered by technician/computer (listed)
96120	Neuropsychological test administered by technician/computer (listed)

Noncovered BMM MethodsmixedNot Covered

single photon absorptiometry	Listed as noncovered BMM method
dual photon absorptiometry	Listed as noncovered BMM method

Care Plan Oversight monthly time — CPO minimum monthly time

Minimum monthly physician time>= 30 minutes of physician CPO furnished within the calendar month

Non-countable timeTime by physician's nurse or consultation with nurse does not count toward 30 minutes

Discharge day exceptionWork included in discharge day management (99238-99239) or observation discharge (99217) not countable on same discharge day unless separately documented after physical discharge

Prerequisite face-to-face encounter window for CPO — face-to-face encounter window required prior to first CPO service

Background and Policy Scope

Chapter 15 of the Medicare Benefit Policy Manual defines the scope of Medicare Part B (Supplementary Medical Insurance) and provides the framework for coverage of outpatient physician services, outpatient hospital services, durable medical equipment, prosthetics, orthotics, supplies, therapy services, preventive screenings, vaccines, and other outpatient benefits. It also clarifies when Part B expenses are considered incurred and includes special rules for events such as surgery, childbirth, infertility treatment, and custom‑made durable items.

CMS established a permanent bundled payment for home intravenous immune globulin (IVIG) items and services effective for infusions furnished on or after January 1, 2024. The bundled payment is made to a durable medical equipment supplier and covers items and services furnished in the home during a calendar day. Importantly, under this permanent bundle a pump is not covered as part of the home IVIG items and services payment.

If the Food and Drug Administration determines that a firm is producing compounded drugs in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA)—for example, by mass production beyond pharmacy practice or manufacturing without required NDA approval—Medicare will not pay for those compounded drugs. Medicare also will not pay for durable medical equipment or prosthetic devices used to administer such nonapproved or misbranded drugs once CMS notifies A/B MACs of the FDA determination.

Key Definitions

SMI (Medicare Part B) — Supplementary Medical Insurance definition

SMI definitionSupplementary Medical Insurance (SMI) — Medicare Part B coverage of specified outpatient and physician services and related supplies

Covered categories examplesIncludes physician services, outpatient hospital services, diagnostic tests, outpatient therapy, vaccines, bone mass measurements, and home health visits after Part A exhausted

ReferenceSee Pub. 100-01, Chapter 15 for detailed Part B provisions

Physician services — Definition of physician services

Physician services definitionProfessional services performed by a physician for a patient including diagnosis, therapy, surgery, consultation, and care plan oversight; the physician must render the service for coverage

Settings

Policy Changes and Revision History

2024-01-01material_changeLatest

CMS established a permanent bundled payment for home IVIG items and services to be paid to a durable medical equipment supplier for infusions furnished in the home, effective for services on or after January 1, 2024; a pump is not covered under the bundle.

2023-12-27legislative_mandate_reference

Division FF, section 4134 of the Consolidated Appropriations Act, 2023 mandated that CMS establish the permanent bundled payment for home IVIG administration in the home.

Summary of additional material changes: CMS implemented a permanent bundled home IVIG items and services payment effective January 1, 2024 as required by Division FF, section 4134 of the Consolidated Appropriations Act, 2023. The bundle is payable to a durable medical equipment supplier for items and services furnished in the home during a calendar day; inclusion of specific items (for example, a pump) is at provider discretion, but a pump is not covered under the bundled payment.

OpenPayer

Chapter 15 - Covered Medical and Other Health Services (Medicare Part B coverage criteria)

Medicare Part B Coverage Criteria (Chapter 15)

Provider Actions, Billing and Documentation Requirements

Coding, Codes and Key Numeric Thresholds

Background and Policy Scope

Key Definitions

Policy Changes and Revision History