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

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Governs Medicare Part B coverage categories, rules for when Part B expenses are considered incurred, and specific provisions for items and services (e.g., surgery/childbirth, custom-made durable items). Affects providers billing Medicare Part B and suppliers of covered items.

Policy Summary

PayerHealthfirst

PolicyChapter 15 - Covered Medical and Other Health Services

Policy CodePolicy N/A

Change TypeMaterial — payment bundle added for home IVIG

Effective DateN/A

Next Review DateN/A

Key ActionDocument and bill home IVIG as a permanent bundled payment to a durable medical equipment supplier per guidance for infusions on/after 01-01-2024.

SourceLink

POLICY UPDATE CHANGES

Permanent bundled payment for home IVIG items and services effective for home IVIG infusions furnished on or after January 1, 2024.

15Chapter

50+Sections listed

1/1/2024Home IVIG change

30 minCPO monthly threshold

6 monthsCPO face-to-face window

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

Policy Summary

PayerHealthfirst

PolicyChapter 15 - Covered Medical and Other Health Services

Policy CodePolicy N/A

Change TypeMaterial — payment bundle added for home IVIG

Effective DateN/A

Next Review DateN/A

Key ActionDocument and bill home IVIG as a permanent bundled payment to a durable medical equipment supplier per guidance for infusions on/after 01-01-2024.

SourceLink

On This Page

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.

Scope of Private Contract: The private contract applies to all Medicare-covered items and services the opt-out physician/practitioner furnishes during the opt-out period (except emergency/urgent care to beneficiaries without a private contract); services furnished under compliant private contracts are not covered by Medicare.applies to Medicare-covered services

Pub.100-02, Chap.15 §40.2 and §40.5.

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.45 days

Pub.100-02, Chap.15 §40.11 and §40.12.

Administrative recordkeeping: Contractor must maintain opt-out physician data (name, TIN/NPI, opt-out effective and end/cancellation dates, automatic renewal date for affidavits on/after 6/16/2015) and notify NSC and Medicare Advantage plans of opt-out identities.

Pub.100-02, Chap.15 §40.27 and §40.37.

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.

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

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

Billing Rule

ABN and opt‑out claim submission

When an ABN is used, follow the beneficiary's written directive about whether a claim should be submitted to Medicare. Non‑opt‑out providers must submit claims for items/services that are, or may be, covered unless the beneficiary validly refuses via ABN. Opt‑out providers must not use ABNs (they use private contracts instead) except for emergency/urgent care.

ABN documents beneficiary choice on claim submission — providers must follow it
Non‑opt‑out providers: mandatory claim submission applies unless beneficiary directs otherwise via ABN
Opt‑out providers: do not use ABNs; use private contracts except emergency/urgent care

Prior Authorization

Affidavit filing and renewal

Opt‑out affidavits must be filed in writing with all MACs where the physician/practitioner would have filed claims. Affidavits signed on or after June 16, 2015, automatically renew every 2 years. Providers who do not want automatic renewal must notify all contractors they filed with in writing at least 30 days before the next opt‑out period. Affidavits signed before June 16, 2015, expire 2 years after the effective date and must be renewed within 30 days after expiration to extend.

File affidavit in writing with each MAC where claims would have been filed
Affidavits signed on/after 2015‑06‑16 automatically renew every 2 years
To cancel automatic renewal: notify all contractors in writing ≥30 days before next opt‑out period
Affidavits before 2015‑06‑16 expire after 2 years and require timely renewal

Documentation Required

Identification and enrollment requirements for opt‑out providers

Providers who opt out but have not enrolled (no NPI) must include their TIN on the opt‑out affidavit. Contractors must annotate provider files with opt‑out status and may obtain additional identifying info (license, address, etc.) from affidavits or external sources. An opt‑out ordering/certifying physician must have an NPI to order/certify services for Medicare; contractors must notify providers to obtain an NPI if needed.

If no NPI exists, include TIN on affidavit
Medicare contractor annotates in‑house provider file with opt‑out status
If needed for ordering/certifying, physician must obtain and report a valid NPI

Billing Rule

Emergency/urgent care claim submission by opt‑out providers

When an opt‑out physician/practitioner furnishes emergency or urgent care to a beneficiary without a private contract, the provider must submit a Medicare claim using the GJ modifier (and other appropriate modifiers) to indicate emergency/urgent care by an opt‑out provider. If the GJ modifier is not used, the contractor must deny the claim so the beneficiary can appeal.

Use GJ modifier on claims for emergency/urgent services by an opt‑out physician/practitioner
If GJ is omitted, contractor will deny claim to permit beneficiary appeal
Provider may not charge more than limiting charge (physician) or applicable deductible/coinsurance (practitioner) in these cases

Documentation Required

Bone Mass Measurement ordering, frequency, and noncovered methods

Bone mass measurements (BMM) must be ordered by the treating physician or qualified NPP after evaluation and documentation of need. Medicare covers screening BMM once every 2 years (≥23 months since prior). Monitoring BMM to assess response to FDA‑approved osteoporosis therapy must use dual‑energy x‑ray absorptiometry (axial skeleton). Noncovered BMM methods (e.g., single photon absorptiometry, dual photon absorptiometry) are not payable.

Order by treating physician or qualified NPP; document evaluation and rationale
Screening BMM frequency: once every 2 years (≥23 months)
Monitoring during osteoporosis drug therapy: use DXA (axial skeleton)
Noncovered methods include single photon absorptiometry and dual photon absorptiometry

Denial Risk

Failure to submit a claim within 1 year — consequences

If a provider or supplier fails to submit a claim on behalf of a beneficiary for a covered Part B service within 1 year of providing the service, or repeatedly and knowingly charges over applicable limits, they may be subject to civil monetary penalties and referral to OIG. Mandatory claim submission rules cannot be negotiated away except for valid opt‑out arrangements.

Failure to submit claim within 1 year may trigger civil monetary penalties (sections 1848(g)(1) and (3))
Repeated, knowing overcharges can lead to penalties and OIG referral
Exceptions exist only for properly executed opt‑out/private contract situations

Denial Risk

Denial triggers for services by opt‑out providers

Services furnished by a physician or practitioner who has opted out are not covered by Medicare and claims including such services on or after the opt‑out effective date must be identified and denied, except as allowed under §40.6 (limited beneficiary payments and emergency/urgent care rules). Contractors must have systems to automatically identify opt‑out providers and deny payment when appropriate.

Medicare makes no payments to opt‑out providers for services on/after opt‑out effective date (except emergency/urgent care)
Claims with opt‑out provider items/dates must be identified and denied unless §40.6 exceptions apply
Contractors must ensure systems flag opt‑out providers to prevent improper payment

Note

Oral anti‑emetic coverage requirements and exclusions

Oral anti‑emetic drugs are covered only when FDA‑approved as anti‑emetics and used as a full therapeutic replacement for IV anti‑emetics in a chemotherapy regimen. They must be initiated within 2 hours of chemotherapy and continued no more than 48 hours, and may not be used beyond that scope to treat side effects adjunctively. Non‑FDA‑approved oral agents used adjunctively are not covered.

Covered only if FDA‑approved for anti‑emetic use and prescribed per regimen
Initiate within 2 hours of chemo; supply limited to loading dose + ≤48 hours
Oral agents used adjunctively or not FDA‑approved as anti‑emetics are not covered

Denial Risk

Duplicate testing and limits on additional diagnostic sessions

Diagnostic testing that duplicates previous testing performed by the attending physician, to the extent the earlier results remain pertinent, is not reasonable and necessary and is not covered. For sleep clinics and other testing facilities, additional sessions beyond ordinarily expected (e.g., >3 naps for narcolepsy or >1 polysomnogram for sleep apnea) require persuasive medical justification documented in the record.

Duplicate testing with still‑pertinent prior results is noncovered
Sleep testing: narcolepsy ordinarily = up to 3 naps; >3 requires justification
Sleep apnea: ordinarily one polysomnogram; >1 requires persuasive medical evidence

Billing Rule

Order and coverage triggers for audiology services and mandatory claims

Audiology diagnostic tests require a physician or qualified NPP order for diagnostic purposes; tests performed solely to fit/modify hearing aids are excluded. If an audiologist charges a beneficiary for a Medicare‑covered service, the audiologist must submit a claim to Medicare (mandatory claim submission). Orders must specify tests when a technician is used; audiologists may select test batteries when a qualified physician/NPP orders tests without naming specific procedures.

Physician or NPP order required for diagnostic audiology tests to be covered
Tests for fitting/modifying hearing aids are excluded from coverage
If an audiologist charges a beneficiary for a covered service, they must submit a Medicare claim

Denial Risk

Lab pickup services — coverage limits

Independent laboratory specimen pickup is medically necessary only when a patient is confined to the home or institutional residence and the service requires a lab technician's skills (e.g., venipuncture). Pickup by a messenger for specimens not requiring technician skills (e.g., urine, sputum) is not medically necessary and is not covered.

Specimen pickup covered when patient is homebound or institutionalized and venipuncture/technician required
Specimen types requiring only messenger pickup (urine, sputum) are not covered for pickup service by independent labs

Documentation Required

Provision to furnish additional tests when treating physician not reachable

For testing facilities that cannot reach the treating physician, additional diagnostic tests may be furnished only if all criteria are met: the facility performed the ordered test; the interpreting physician documents that an additional test is medically necessary due to abnormal results; delay would adversely affect care; results are communicated to and used by the treating physician; and the interpreting physician documents why additional testing was done.

Testing center must have performed the originally ordered diagnostic test
Interpreting physician documents medical necessity for additional test due to abnormal result
Delay would adversely affect beneficiary care and results are communicated to treating physician
Interpreting physician must document reasons for additional testing

Documentation Required

Supervision versus practitioner‑performed diagnostic tests — documentation

When non‑physician practitioners (NP, CNS, PA) personally perform diagnostic tests under §1861(s)(2)(K), the diagnostic test supervision rules apply to their practitioner benefit category per state scope‑of‑practice laws; the 'incident to' supervision rules do not apply. Ensure billing and supervision documentation demonstrates the practitioner performed the test and met applicable supervision standards.

Diagnostic tests performed personally by NPPs follow test supervision standards for their practitioner benefit category
'Incident to' supervision rules do not apply to diagnostic tests benefit category
Retain documentation showing practitioner performed test and applicable supervision level

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

1–10 of 16

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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

Required prior face-to-face encounterPhysician must have furnished a covered E/M service with a face-to-face encounter within the 6 months immediately preceding the first CPO service

Acceptable encounter typesOnly evaluation and management (E/M) services qualify as the prerequisite face-to-face encounter

Insufficient encounter typesEKG, lab, and surgical services are not sufficient as the prerequisite face-to-face encounter

Urgent care timing — Definition window for urgent care services

Urgent care definition windowServices furnished within 12 hours to avoid the likely onset of an emergency medical condition (urgent care)

Emergency care distinctionEmergency care services are those necessary to prevent death or serious impairment and require the most accessible hospital equipped to furnish them

ExampleEar infection with significant pain may be urgent care if treatment needed within 12 hours to avoid complications

Usually self-administered threshold — Threshold defining 'usually' self-administered (>50%)

'Usually' self-administered thresholdMore than 50% of Medicare beneficiaries who use the drug self-administer it (>50%)

Indication-specific determinationMACs should determine 'usually' separately for each indication and then use a weighted average across indications

PresumptionsAbsent evidence, presume IV/IM not usually self-administered and SC usually self-administered

Advance notice period for noncovered drugs — Advance notice MACs must provide before denying payment for excluded drugs (45 days)

Advance notice periodA/B MACs and DME MACs must provide 45 days' notice before denying payment for injectable drugs determined to be usually self-administered

Public posting requirementMACs must publish their process and list of excluded injectable drugs with data and rationale on their websites

Maintenance during notice periodDuring the 45-day period, MACs maintain existing medical review and payment procedures

PCV15→PPSV23 interval — Minimum interval between PCV15 and PPSV23 (≥1 year; exceptions noted)

PCV15 → PPSV23 minimum intervalClinical guidance: when PCV15 is used, follow with PPSV23 at an interval of ≥1 year (minimum 8 weeks may be considered for immunocompromised, cochlear implant, or CSF leak)

Special populationsMinimum 8-week interval may be considered for adults with immunocompromising conditions, cochlear implant, or cerebrospinal fluid leak

PCV20 after PPSV23 guidanceFor adults who only received PPSV23 previously, a PCV (PCV20 or PCV15) may be given ≥1 year after last PPSV23 dose; if PCV15 used after PPSV23, no further PPSV23 needed

PCV20 after PPSV23 — Interval guidance when PPSV23 previously given

PCV20 after prior PPSV23Adults who only received PPSV23 may receive a PCV (PCV20 or PCV15) ≥1 year after their last PPSV23 dose; when PCV15 used after PPSV23 it need not be followed by another PPSV23

Timing when PPSV23 previously givenEnsure at least a 1-year interval after last PPSV23 before administering PCV (per CMS guidance)

No repeat PPSV23 requiredIf PCV15 is given after prior PPSV23, an additional PPSV23 dose is not required following PCV15

Antigen reasonable supply — Maximum 'reasonable supply' of patient-prepared antigens (12 months)

Maximum reasonable supplyNot more than a 12-month supply of physician-prepared antigens prepared for a particular patient at any one time

Preparation and supervisionAntigens must be prepared by an MD/DO who examined the patient and determined a treatment plan and dosage; administered per plan by MD/DO or properly instructed person under physician supervision

Purpose of limitationReasonable supply limitation ensures antigens retain potency and effectiveness over administration period

Oral anti-emetic initiation window — Initiation and continuation timing limits for oral anti-emetics

Initiation windowOral anti-emetics must be initiated within 2 hours of chemotherapy administration

Maximum continuationMay be continued for no more than 48 hours from the time of chemotherapy (loading dose plus up to 48 hours supply)

Coverage conditionOral anti-emetics must be FDA-approved as anti-emetics and used as a full therapeutic replacement for the IV anti-emetic that would otherwise be given

EPO hematocrit thresholds — Initiating and continuing hematocrit thresholds for EPO use

Hematocrit threshold to initiate EPOInitiating: hematocrit no higher than 30% (exceptions allowed with medical documentation)

Continuing hematocrit rangeContinuing therapy: hematocrit between 30% and 36%

Documentation requirementMedical record must include diagnostic coding, most recent creatinine and hematocrit values with dates, dosage, weight, and units administered

Number of diagnostic nights/naps before justification required — Sleep study session count thresholds requiring justification

Narcolepsy nap limitOrdinarily narcolepsy can be confirmed by three sleep naps; more than 3 naps claimed requires persuasive medical justification

Polysomnogram limit for sleep apneaOrdinarily a single polysomnogram suffices for sleep apnea; more than one polysomnogram claimed requires persuasive medical evidence

Impotence nocturnal testing limitOrdinarily two nights of diagnostic testing determine impotence; more than two nights claimed requires persuasive justification

BMM screening frequency — Medicare screening BMM frequency standard (once every 2 years)

Screening frequency standardBone mass measurement (screening BMM) payable once every 2 years (at least 23 months since last covered BMM)

More frequent testingMedicare may pay for more frequent BMMs when medically necessary (e.g., monitoring long-term glucocorticoid therapy)

Ordering requirementBMM must be ordered by the treating physician or qualified NPP and used in patient management

Glucocorticoid therapy threshold — Glucocorticoid therapy criterion for BMM coverage (>=5.0 mg/day prednisone equiv. >3 months)

Glucocorticoid therapy criterionCoverage indication includes individuals receiving or expecting to receive glucocorticoid therapy equivalent to an average of 5.0 mg prednisone per day for more than 3 months

Use-case for coverageThis criterion is listed as one of five conditions that qualify a beneficiary for covered BMM

Documentation expectationOrdering clinician should document medical need and rationale for BMM when based on glucocorticoid therapy

Glucocorticoid exposure — Restatement of exposure threshold for BMM

Glucocorticoid exposure restatementExposure defined as equivalent to an average of >= 5.0 mg prednisone per day for more than 3 months

Coverage implicationMeets one of the qualifying conditions for BMM coverage when documented by treating clinician

Monitoring noteMay justify more frequent BMM when medically necessary for patients on prolonged glucocorticoid therapy

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

SettingsServices may be performed in a home, office, institution, or at the scene of an accident

Direct visualization allowanceInterpretation of transmitted diagnostic data (e.g., ECG) may constitute a physician service if physician can visualize patient's condition

Professional component vs provider component — Definition and differentiation

Professional vs provider componentProfessional component: physician activities directly related to individual patient care (paid under Part B); Provider component: activities not directly related to individual patient care (teaching, administration) paid to provider under Part A

Examples professionalIdentifiable medical services by physician that contribute to diagnosis or treatment

Examples providerTeaching, research, administration, general supervision, lab quality control — part of provider's PPS rate

Interns and Residents — Definition for coverage purposes

Interns and residents definitionPhysicians participating in approved postgraduate training programs and physicians authorized to practice only in a hospital setting (including temporary/restricted license holders and unlicensed foreign graduates)

Payment ruleMedical and surgical services furnished by interns/residents within scope of approved training program are paid as provider services

Status noteSenior resident titles (e.g., fellow) do not change Medicare coverage/payment status

Physician/Practitioner (opt-out definition) — Who qualifies as physician/practitioner for opt-out

Opt-out physician/practitioner definitionFor opt-out: 'physician' includes MD, DO, DDS/DMD, DPM, and certain optometrists authorized by State law; 'practitioner' includes PAs, NPs, CNSs, CRNAs, CNMs, clinical psychologists, clinical social workers, registered dietitians, and nutrition professionals

Private contract definitionA written agreement between a Medicare beneficiary and an opt-out physician/practitioner for a 2-year period where beneficiary agrees to forgo Medicare payment and pay provider directly

Opt-out term lengthOpt-out affidavit makes physician/practitioner out of Medicare for two years from signature unless terminated early or failure to maintain opt-out

Physician/Practitioner — Additional opt-out role definition

Physician/Practitioner (general)'Physician' includes MD, DO, DDS/DMD, DPM, and certain optometrists authorized by State law; 'practitioner' includes PAs, NPs, CNSs, CRNAs, CNMs, clinical psychologists, clinical social workers, registered dietitians, and nutrition professionals

Non-qualifying providersChiropractors and independently practicing PT/OT cannot opt out because they are not within the opt-out definitions

Legal authorization requirementPractitioners must be legally authorized by State law and meet Medicare requirements to qualify

Private contract — Definition of private contract between beneficiary and opt-out practitioner

Private contract key pointsA private contract is a written agreement between a beneficiary and an opt-out physician/practitioner for a 2-year period; beneficiary agrees to forgo Medicare payment and pay the provider directly

Contract duration and effectOnce affidavit filed, opt-out status and private contracts apply for two years from the affidavit signature date unless terminated early

Beneficiary rightsBeneficiary who signs private contract may still receive services from other non-opt-out physicians who bill Medicare

Emergency and Urgent Care — Definition windows for urgent and emergency care

Emergency and urgent care definitionsEmergency care: services necessary to prevent death or serious impairment requiring the most accessible hospital; Urgent care: services furnished within 12 hours to avoid likely onset of an emergency medical condition

Application to opt-outEmergency/urgent care exceptions allow payment for services by opt-out physicians to beneficiaries without a private contract when conditions met

Example of urgent careTreatment within 12 hours for an ear infection with significant pain to avoid adverse consequences

Administered — Definition regarding how drug enters the body

Administered (drug) definitionRefers only to the physical process by which the drug enters the patient's body; does not refer to supervision by a medical professional

Routes typically eligibleInjectable drugs, including IV administered drugs, are typically eligible for inclusion under 'incident to' benefit; oral/topical usually self-administered

Implication'Administered' focuses on how drug enters body when determining coverage categories, not who supervises the administration

Usually (self-administered) — Definition used for exclusion determinations (>50%)

'Usually (self-administered)' definitionMeans more than 50% of Medicare beneficiaries using the drug for outpatient medically necessary indications self-administer it; determination is drug- and indication-specific with weighted averaging

Population consideredDetermination based on Medicare beneficiaries as a collective whole; excludes inpatient administrations and non-patient caregivers

Acute condition noteAcute conditions and frequency/duration factors should be considered by MACs when determining usual self-administration

Acute condition (for self-administration determination) — Definition used in that context

Acute condition (self-admin determination)A condition that begins over a short time, likely short duration, or expected finite treatment course; scheduled injections lasting less than 2 weeks are considered acute

Evidence sourcesEvidence may include FDA approval language, package inserts, drug compendia, and other information to support acute classification

Impact on self-admin determinationAcute-course treatments may influence MAC determinations about whether a drug is usually self-administered

Unlabeled use — Definition of off-label/unlabeled use

Unlabeled/off-label use definitionUse of an FDA-approved drug for an indication not included on the official FDA-approved label; may be covered if MAC determines use to be medically accepted based on compendia, literature, or standards

Anti-cancer regimen noteUnlabeled uses in anti-cancer regimens may be covered as medically accepted per compendia and peer-reviewed literature; contractor may request supporting documentation

Case-by-case MAC determinationsMACs make coverage decisions for unlabeled uses on a case-by-case basis considering authoritative sources

Incident-to — Definition of incident-to coverage

Incident-to definitionConditions for drugs/biologicals furnished 'incident to' a physician's service: drug form not usually self-administered; furnished by a physician; administered by physician or auxiliary personnel under physician's personal supervision; drug charge included on physician's bill

Supervision requirementAdministration must be under the physician's personal supervision (physician present and immediately available in office setting)

Billing and expenseCharge for the drug/biological must be included in physician's bill and represent an expense to the physician or billing entity

Regimen — Definition relevant to anti-cancer drug coverage

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

RelevanceDefinition used to determine coverage of off-label uses in anti-cancer chemotherapeutic regimens

Support sourcesMedically accepted off-label indications supported by compendia or peer-reviewed literature may be covered

Part B immunosuppressive drug benefit (Part B-ID) — Definition and historical note

Part B immunosuppressive drug benefit (Part B-ID)A Medicare Part B benefit providing coverage solely for immunosuppressive drugs; historical time limit eliminated for drugs furnished on/after Dec 21, 2000 and Part B-ID established for certain ESRD transplant beneficiaries effective Jan 1, 2023

Coverage criteria summaryCovered drugs include FDA-approved drugs labeled for preventing/treating transplant rejection, drugs determined by MAC to be reasonable/necessary for rejection, and compounded formulations derived only from such drugs when orally/enterally administered

ExclusionsAntibiotics, hypertensives, and other drugs not directly related to rejection are not covered under Part B immunosuppressive benefit

Intravenous immune globulin (IVIG) — Definition of IVIG and coverage context

IVIG definitionIntravenous immune globulin (IVIG) is an approved pooled plasma derivative covered for treatment of primary immune deficiency disease when administered in the patient's home and physician determines home administration is medically appropriate

Bundled payment noteCMS established a permanent bundled home IVIG items and services payment effective Jan 1, 2024; bundled payment is made to a DME supplier and pump is not covered under the bundle

Coverage conditionsCoverage requires diagnosed primary immune deficiency disease and home administration deemed medically appropriate by physician

Intravenous immune globulin (IVIG) — Additional IVIG definition and bundled payment context

Home IVIG bundled payment contextIVIG covered under home infusion bundled payment when criteria met; permanent bundled payment effective 01-01-2024 paid to DME supplier

Pump exclusionA pump may be used but is not covered under the permanent bundled home IVIG items and services payment

Provider discretionProvider determines services and supplies appropriate to administer IVIG in the home for each patient

Homebound (Medicare Home Health benefit) — Criteria-One and Criteria-Two overview

Homebound (Medicare Home Health) Criteria-One and TwoHomebound requires meeting Criteria-One (need for supportive devices/special transportation/assistance or leaving home medically contraindicated) and Criteria-Two (normal inability to leave home and leaving requires considerable taxing effort)

Examples and allowable absencesAbsences for health care treatment (e.g., dialysis, chemo/radiation) or infrequent/short nonmedical absences do not negate homebound status

Physician certificationPhysician must certify patient confined to home for home health benefit eligibility

Homebound patient — Short definition

Homebound patient short definitionPatient with a normal inability to leave home where leaving home requires considerable and taxing effort; absences infrequent/short or for health care treatment allowed

Allowed medical absencesIncludes outpatient kidney dialysis, outpatient chemotherapy or radiation, and adult day centers to receive medical care

Nonmedical absencesOccasional trips (barber, religious services, family events) of short duration do not negate homebound status if infrequent

Supervision levels — General/Direct/Personal supervision definitions

Supervision levelsGeneral, Direct, and Personal supervision defined for diagnostic tests: General = overall direction (physician not required present); Direct = physician present in office suite and immediately available; Personal = physician in attendance in the room

Regulatory referenceLevels defined per 42 CFR 410.32(b) and MPFS supervision assignments

ApplicabilityDiagnostic tests payable under physician fee schedule must meet appropriate physician supervision level

Audiology services — Definition and scope

Audiology services definitionHearing and balance assessment services furnished by a qualified audiologist as legally authorized under State law; termed 'audiology services' regardless of furnisher

ScopeIncludes diagnostic programming of certain prosthetic devices, evaluation of hearing, balance, auditory processing, and tinnitus

Reporting guidanceReport under most specific HCPCS/CPT code per Medicare and MAC instructions

Independently Practicing Psychologist (IPP) — Definition

Independently Practicing Psychologist (IPP)A psychologist licensed or certified in the State where services are furnished, or any practicing psychologist where the jurisdiction does not license, who may render services and bill directly

Billing conditionIPP services covered when a physician orders such tests; MAC may require verification of qualifications from State agencies

Related providersCPs, NPs, CNSs, PAs may also bill to extent authorized by State scope of practice

Bone mass measurement (BMM) — Definition

Bone mass measurement (BMM) definitionA radiologic, radioisotopic, or other procedure to identify bone mass, detect bone loss, or determine bone quality using an FDA-cleared densitometer or sonometer and including physician interpretation

Screening frequencyScreening BMM payable once every 2 years (at least 23 months since last covered BMM)

Covered indicationsFive qualifying conditions (e.g., estrogen-deficient women at risk, vertebral abnormalities, glucocorticoid therapy ≥5 mg prednisone/day >3 months, primary hyperparathyroidism, monitoring osteoporosis therapy)

Qualified audiologist — Definition and training requirements

Qualified audiologist requirementsMaster's or doctoral degree in audiology and licensed as audiologist in the State, or in non-licensure states must complete 350 supervised practicum hours, 9 months supervised full-time post-degree experience, and pass a national exam

MAC determination roleIf unclear, MAC determines whether qualifications met for audiology services

Scope exceptionPhysician or NPP may perform audiological tests in States where allowed by State/local laws

Diagnostic Test — Definition

Diagnostic Test definitionIncludes all diagnostic x-ray tests, all diagnostic laboratory tests, and other diagnostic tests furnished to a beneficiary

ApplicationUsed for coverage and supervision requirements under diagnostic testing sections

Order requirementTesting must be ordered by treating physician/practitioner and results used in management

Treating Physician — Definition

Treating Physician definitionPhysician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses diagnostic test results in management of that problem

Radiologist noteRadiologist performing therapeutic interventional procedure is considered treating physician; diagnostic radiologist is not

Order/use linkageOrders and testing must be linked to treating physician's management to be covered

Treating Practitioner — Definition

Treating Practitioner definitionA nurse practitioner, clinical nurse specialist, or physician assistant who, pursuant to State law, furnishes a consultation or treats a beneficiary for a specific medical problem and uses diagnostic test results in management

Scope requirementMust act within State scope of practice to be considered treating practitioner for ordering and management

Relation to BMM/ordersMay order BMMs when qualified and treating clinician role established

Testing Facility — Definition

Testing Facility definitionA Medicare provider or supplier that furnishes diagnostic tests, which may include physicians, laboratories, or independent diagnostic testing facilities (IDTFs)

Role in additional testsTesting facility may furnish additional tests without new order only when specified criteria are met and attempts to reach treating physician documented

Documentation requirementFacility must document orders and communications per testing rules

Order — Definition of an order and acceptable communication forms

Order definition and formsAn order is a communication from the treating physician/practitioner requesting a diagnostic test; it may be written (hand-delivered, mailed, faxed), by telephone, or by electronic mail

Telephone order documentationIf order via telephone, both ordering office and testing facility must document the call in their copies of patient's medical records

Signature noteNo signature required for clinical diagnostic tests paid on CLFS or physician fee schedule, but physician must document intent when ordering

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.