Currentpriority healthPolicy N/A

Chapter 15, Covered Medical and Other Health Services

Portion of Chapter 15 describing the scope of Part B Supplementary Medical Insurance (SMI) coverage, rules for date of expense incurred, physician service policies (concurrent care, care plan oversight, documentation, teaching physician rules), preventive/screening services (colorectal screening age lowered to 45), DME and home infusion policies, and opt-out/private contract guidance.

Policy Summary

Payerpriority health

PolicyChapter 15, Covered Medical and Other Health Services

Policy CodePolicy N/A

Change TypeMultiple transmittal updates (coverage, coding, payment rules)

Effective Date

Next Review Date

Key ActionDocument services and required timings (e.g., CPO 30 minutes/month, plan of care certifications) and follow updated billing/order rules (e.g., FOBT orderers, screening age change to 45).

SourceLink

POLICY UPDATE CHANGES

Minimum age for screening tests (FOBT, flexible sigmoidoscopy, barium enema, screening colonoscopies) reduced to 45 years effective January 1, 2023.

Expanded list of providers authorized to order screening FOBT for dates of service on or after January 27, 2014 to include physician assistant, nurse practitioner, or clinical nurse specialist.

Effective January 1, 2008 ASC list and payment updates moved to annual updates concurrent with hospital OPPS rulemaking.

Billing for home infusion therapy services effective January 1, 2021 established (Transmittal R10547BP).

Definitions and payment rules for MFT and MHC services added/updated effective January 1, 2024 (Transmittal R12448BP).

Multiple transmittals listed with issue dates, subject lines, implementation dates, and CR numbers documenting topic-specific manual updates (e.g., telehealth expansion, therapy services, vaccines, rehabilitation services).

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27+Listed Covered Service Categories in this part

30CPO monthly minimum time requirement

>50%Usually self-administered threshold (%)

2010-01-01Consultation CPT code policy change date

2Standard opt-out period (years)

2023Screening age change effective year

Coverage Summary & Scope

This extract covers the first portion of Chapter 15 (Supplementary Medical Insurance - Part B topics). It mirrors Medicare Chapter 15 and enumerates the Part B benefit scope and core program rules, including when expenses are incurred, physician services and related special policies, and a broad set of covered service categories.

High-level scope bullets (covered Part B service categories in this extract):

- Physician services (diagnosis, therapy, surgery, consultation, care plan oversight) [[21],[28]]

- Outpatient hospital and ASC services including ASC facility rules [[11],[582]]

- Outpatient rehabilitation therapy (PT, OT, SLP) with plans of care, certification, documentation and supervision rules [[11],[422]]

- Durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) including definitions, repair/replacement, delivery, and benefit-category determinations [[11],[274],[301]]

- Diagnostic tests, labs, and sleep disorder testing with ordering, supervision, and testing-facility rules [[11],[202],[209]]

- Preventive/screening services (mammography, Pap, glaucoma, colorectal screening, AWV, vaccines) [[11],[642],[613],[650]]

- Vaccines and immunizations (influenza, pneumococcal, hepatitis B, COVID-19) including in‑home additional payment criteria [[11],[136],[142],[144]]

- Drugs & biologicals coverage/incident-to rules, self-administered drug determinations, compendia/off-label/less-than-effective rules [[107],[111],[151],[159]]

- Home infusion and home IVIG coverage and payment/bundling rules (including permanent bundled home IVIG payment effective 2024‑01‑01) [[699],[179],[715]]

- Opt-out/private contract/affidavit rules and contractor processes for tracking, denials, and appeals [[48],[51],[63]]

- Care Plan Oversight (CPO) criteria and Care plan/documentation requirements [[28],[29],[30]]

- Teaching physician, interns/residents, and supervision rules for Part B payment and documentation [[35],[36],[31]]

- Chiropractic, podiatry/foot care, and specialized services (limitations, maintenance exclusions, contraindications) [[42],[658]]

- Behavioral health coverage expansions (MFT/MHC services) and qualifications [[721],[722]]

Key thresholds & operational facts

CPO monthly minimum>= 30 minutes per calendar month

CPO prerequisite face-to-faceE/M face-to-face within 6 months prior to first CPO service

Usual self-administered drug threshold>50% of Medicare beneficiaries (per drug/indication weighted)

Opt-out period length2 years (initial; affidavits filed on/after 2015-06-16 auto-renew every 2 years unless cancelled)

Opt-out contractor cure period45 days to respond/develop after Medicare contractor notice

Opt-out early termination windowWithin 90 days of affidavit effective date with refund requirements

Home IVIG payment effectiveBundled home IVIG payment effective 2024-01-01 (DME supplier daily bundle)

Medical Necessity & Coverage Criteria (Grouped)

Supplementary Medical Insurance (SMI) Covered Services — The following grouped criteria reflect Medicare/SMI rules and program-specific operational notes as they apply to provider types, opt-out/opt-in rules, drugs/biologics, incident-to rules, DMEPOS, diagnostic testing, therapy services, and other coverage determinations. Each criteria_group preserves the original hierarchical logic (ALL/ANY) where applicable and includes operational notes where necessary.

Optometrist Services

Optometrist services are covered when delivered by a qualified optometrist within the scope of state law and Medicare’s definition of physician’s services; payment follows applicable Medicare rules for physician services and is subject to documentation and medical necessity requirements.

Chiropractor Services

Chiropractic manipulation services are covered when furnished by a doctor of chiropractic and only for manual manipulation of the spine to correct a subluxation demonstrated by X-ray or manual exam; other services (e.g., modalities) are not covered unless separately established as medically necessary under Medicare rules.

Indian Health Service (IHS) Part B Payment Exception

Provider Actions, Supervision, Teaching, and Opt-Out Rules

Teaching physician, interns/residents and payment/documentation

Teaching physician, interns/residents and related payment/documentation rules rendered as grouped criteria preserving required presence and documentation thresholds.

Teaching Physician Services: Part B covers services attended physicians (not interns/residents) render in teaching setting: review history/PE, personally examine within reasonable time, confirm/revise diagnoses, determine course, assure supervision of interns/residents, and make frequent reviews. Medical record must contain signed/countersigned notes showing personal review, visits at critical times, discharge. For surgical procedures, intern/resident notes showing physician physical presence suffice. Teaching physician must be present during key portion of a service rendered by a resident; if resident performed visit without teaching physician present, teaching physician must repeat key portions and document own findings to be paid.

Interns and Residents: Definitions: include physicians in approved postgraduate training programs and physicians authorized to practice only in hospital settings (temporary/restricted licenses). Services by interns/residents within approved program are provider services; moonlighting services outside training program may be covered as physician services when all applicable criteria met (identifiable physician service, fully licensed in State where performed, separable from training duties).

Preventive Services & Screening Rules (AWV, Vaccines, Colorectal, Pap, Glaucoma, Mammography)

AWV, SDOH, Vaccinations, and Colorectal Screening rules

Preventive services: AWV (including SDOH G0136), vaccinations (pneumococcal, influenza, hepatitis B, COVID-19/in-home payment), colorectal screening (FOBT, sigmoidoscopy, colonoscopy, barium enema) with age/frequency/high-risk rules including Jan 1 2023 age change, AWV SDOH element reporting (G0136 with -33).

Annual Wellness Visit (AWV) Eligibility and Elements: AWV (G0438 initial; G0439 subsequent) covered when performed by a health professional for beneficiaries no longer within 12 months after effective date of first Medicare Part B coverage and who have not received IPPE or AWV within past 12 months; coinsurance and Part B deductible waived; elements include health risk assessment, medical/family history, list of current providers/suppliers, measurements (height, weight, BMI/waist, BP), detection of cognitive impairment, depression risk screening, functional ability and safety/fall risk review, written screening schedule for next 5-10 years, personalized health advice and referrals.

SDOH Risk Assessment as AWV Additional Element (CY 2024): Optional SDOH Risk Assessment (G0136) added as AWV element effective Jan 1, 2024; when furnished as AWV element it is separately payable with no beneficiary cost-sharing if reported with Modifier -33 on same claim and same date as payable G0438 or G0439; must be standardized, evidence-based, culturally and linguistically appropriate; if billed without -33 treated as in conjunction with E/M or Behavioral Health visit with deductible/coinsurance; when AWV elements furnished over multiple days date of service is date AWV completed and records should reflect start/completion dates.

Drugs, Compendia, Self-Administration, EPO, Anti-Cancer & Home Infusion

Drugs and biologicals coverage, compendia, self-administration & off-label rules

Drug/biological coverage criteria, compendia requirement, 'usually self-administered' (>50%) determination rules and presumptions, incident-to tests, exclusions, hospital supplies treatment, off-label anti-cancer compendia and peer-review support — preserve >50% threshold and factors.

General coverage criteria for drugs and biologicals under Medicare Part B: Drugs/biologicals covered only if: meet statutory definition; are not usually self-administered (see 50.2); meet incident-to requirements when applicable; are reasonable and necessary per accepted standards; not excluded as noncovered immunizations; not FDA-determined less-than-effective.

Statutory compendia requirement for drug/biological: Payment may be made only where drug/biological is included or approved for inclusion in accepted compendia (USP-NF, USD-DI, ADA Guide to Dental Therapeutics) though compendia inclusion is necessary but not sufficient for coverage.

Determining 'usually self-administered' (>50% threshold): Each A/B MAC determines for each drug and indication whether drug is usually self-administered considering route, indication mix, and evidence; 'usually' means >50% of Medicare beneficiaries using the drug self-administer; determine per indication then compute weighted average across indications; presumptions: IV and IM absent contrary evidence presumed not usually self-administered; SC presumed usually self-administered absent contrary factors (acute condition, infrequent administration decreases likelihood of self-administration; frequent dosing >= once/week increases likelihood); consider peer-reviewed literature, standards, guidelines, FDA label, compendia; A/B MACs must publish process and lists and provide 45 days' notice prior to noncoverage; review at least annually.

Durable Medical Equipment (DME) — Coverage, Repair, Replacement & Billing

Durable Medical Equipment (DME) coverage, definitions, maintenance, delivery and BCD rules

DME-related coverage: definition, necessary & reasonable, period of medical necessity, repairs/maintenance/replacement/delivery rules, supplies and drugs related to DME, incurred expense and shipping date rules, lump-sum delivery exclusion, benefit category determination criteria.

Durable Medical Equipment (DME) Coverage Requirements: Expenses for rental or purchase of DME reimbursable when all three requirements met: equipment meets DME definition; equipment is necessary and reasonable for treatment or to improve functioning of malformed body member; equipment is used in patient's home.

Definition of DME: DME only if: can withstand repeated use; primarily/customarily used to serve medical purpose; generally not useful in absence of illness/injury; appropriate for use in home. Examples presumptively medical: hospital beds, wheelchairs, hemodialysis equipment, respirators, crutches, canes, walkers, nebulizers, commodes, suction machines, traction equipment. Presumptively nonmedical examples listed; special exceptions (gel pads, heat lamps) may be covered with physician supervision and therapeutic purpose documented.

Outpatient Rehabilitation Therapy (PT/OT/SLP) — Plans, Certification, Documentation

Outpatient Rehabilitation Therapy: plans, certification, documentation, maintenance, and supervision

Therapy-related criteria: general coverage principles, plan of care establishment, certification/recertification/delayed certification, plan changes, documentation/claims, reasonable & necessary conditions, maintenance vs rehabilitative therapy, evaluation/re-evaluation, progress report timing/content, treatment note requirements, functional reporting historical, group therapy, personnel qualifications, incident-to rules — include thresholds: certification within 30 days, certification interval <=90 days, progress report every 10 treatment days, delayed report within 7 days.

Outpatient Rehabilitation Therapy - General Coverage Principles: Therapy services must be skilled services furnished by qualified professionals/personnel within scope and consistent with state law; coverage limited to outpatient PT/OT/SLP paid under MPFS or similar hospital-exempt settings; definitive policies include LCDs; plan of care, certification, and documentation requirements apply.

Plan of Care Establishment: A plan of care must be established before treatment begins and include at minimum: diagnoses; long-term treatment goals; type, amount, duration and frequency of therapy services; plan established by physician/NPP or by therapist who will provide services; signature and professional identity and date recorded; different plans required for each therapy discipline; treatment may begin when plan established; treatment may begin before written plan only if performed or supervised by same clinician who establishes the plan.

Specialty Programs: Pulmonary, Cardiac, KDE, DSMT, Sleep Disorders, Chiropractic

Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and ICR

Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR): covered diagnoses, program components, session limits (PR/CR 36 sessions with option for additional 36 by MAC; ICR 72 sessions), physician review every 30 days, MAC approval for additional sessions.

Pulmonary Rehabilitation (PR) - Coverage and Components: PR covered for COPD GOLD II-IV and select indications including confirmed/suspected COVID-19 with persistent respiratory symptoms >=4 weeks; PR must include physician-prescribed exercise (aerobic + other), education/training tailored to individual including respiratory management and smoking cessation as appropriate, psychosocial assessment, outcomes assessment (start/end objective and self-reported measures), individualized written treatment plan established/reviewed/signed by physician every 30 days, settings physician office or hospital outpatient with physician/NPP immediately available and life-saving equipment present; session limits up to 2 1-hour sessions per day, up to 36 sessions over up to 36 weeks with option for additional 36 sessions if approved by MAC.

Cardiac Rehabilitation (CR) - Coverage and Components: CR covered for qualifying cardiac conditions (recent MI within 12 months, CABG, stable angina, valve repair/replacement, PTCA/stenting, heart/heart-lung transplant, and certain chronic heart failure criteria) and other NCD-specified conditions; must include physician-prescribed exercise each day, cardiac risk factor modification (education/counseling/behavioral intervention), psychosocial assessment, outcomes assessment, individualized written treatment plan established/reviewed/signed by physician every 30 days; session limits up to 2 1-hour sessions per day, up to 36 sessions over up to 36 weeks with option for additional 36 sessions if MAC-approved; settings physician office or hospital outpatient with immediate availability of physician/NPP and necessary equipment.

Coding Reference

Colorectal screening HCPCS/CPTmixedCovered

G0122	Colorectal cancer screening; flexible sigmoidoscopy
G0202	Colorectal cancer screening; colonoscopy on individual not meeting criteria for high risk

DME / HCPCS - CoveredHCPCSCovered

A4295	Tracheostomy tube, inner cannula; for use with trach tube (specify)
A4296	Tracheostomy tube, inner cannula, replacement
A4297	Tracheostomy tube, obturator
A4341	Tracheostomy tube, fenestrated, silicone, cuffless
A4342	Tracheostomy tube, fenestrated, silicone, with cuff
A4438	Tracheostomy tray (set)
A4564	Nebulizer, electric or battery operated, with compressor
B4148	Enteral feeding supply, small volume pump, replacement
E0737	Stationary oxygen concentrator, single delivery port, rental

DME / HCPCS - Not CoveredHCPCSNot Covered

A4295-NC

Tracheostomy tube inner cannula (not covered when not medically necessary)

ICD-10 - Primary Immunodeficiency Disorders (examples)ICD-10

D83.0	Common variable immunodeficiency with predominant antibody deficiency (example placeholder)
D84.9	Immunodeficiency, unspecified (example placeholder)

ICD-10 - High-risk colorectal and inflammatory bowel disease codesICD-10

K50.00	Crohn's disease of small intestine without complications
K50.011	Crohn's disease of small intestine with rectal bleeding
K50.012	Crohn's disease of small intestine with fistula
K50.013	Crohn's disease of small intestine with intestinal obstruction
K50.014	Crohn's disease of small intestine with abscess
K50.018	Crohn's disease of small intestine with other complications
K50.019	Crohn's disease of small intestine with unspecified complications
K50.10	Crohn's disease of large intestine without complications
K50.111	Crohn's disease of large intestine with rectal bleeding
K50.112	Crohn's disease of large intestine with fistula

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Opt-out / Denial Codes (CARC/MA/MSG)mixed

CARC	Commonly used denial reason codes for opt-out and private contract situations; see specific claim remittance advice
MA	Medicare Advantage plan adjustment/denial codes
MSG	Message codes related to beneficiary opt-out and private contract processing

Functional reporting G-codes (historical) - 42 codes in 14 setsCPT

G9001	Functional reporting set 1 (example)
G9002	Functional reporting set 2 (example)
G9003	Functional reporting set 3 (example)
G9004	Functional reporting set 4 (example)
G9005	Functional reporting set 5 (example)
G9006	Functional reporting set 6 (example)
G9007	Functional reporting set 7 (example)
G9008	Functional reporting set 8 (example)
G9009	Functional reporting set 9 (example)
G9010	Functional reporting set 10 (example)

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Regulatory Referencesmixed

42CFR484.115	Medicare conditions for coverage for home health: comprehensive assessment of the patient
42CFR485.713	Conditions for coverage: respiratory care services in critical access hospitals
42CFR410.62	DMEPOS: Items paid under the Durable Medical Equipment benefit
Pub.100-02/03/04/08	Medicare Program Integrity and Claims Processing manuals (Pub.100 series) - relevant transmittals and instructions

Top Provider Actions — Documentation, Billing, and Risk

Note

Prioritized provider action callouts (selected high‑priority policies)

Prioritized callouts summarizing key provider actions and affected codes: 1) CPO documentation & 30‑minute rule (documentation): document services, dates, and ≥30 minutes/month; prerequisite E/M within 6 months — codes/refs: CPO rules (Care Plan Oversight) (§F) (see 29). 2) Consultation CPT coding change (billing_rule): do not use CPT 99241‑99245 or 99251‑99255; bill appropriate E/M codes (see 22). 3) Teaching physician requirements (documentation): be present for key portions or repeat key portions and document; signed/countersigned notes required (see 35,31). 4) Opt‑out affidavit filing/maintenance (prior_auth): file affidavit with all MACs including identification (NPI/TIN), retain private contracts for 2‑year period; 45‑day contractor cure period; 90‑day early termination window (see 64,61,71,72). 5) Emergency/urgent GJ modifier and billing (billing_rule): use GJ on claims for emergency/urgent services by opt‑out physicians without private contract; use modifier 54 when billing surgical care only where appropriate; limit charges per Medicare rules (see 94,95). 6) Denials and adjustment/remark codes for opt‑out claims (billing_rule/denial_risk): contractors use CARC 27 with group code PR and MA47 (or MA47 N771) and MSN messaging when denying opt‑out claims (see 105,106). 7) Compendia/FDA evidence for off‑label anti‑cancer use (documentation): obtain compendia or peer‑reviewed literature (NCCN, DrugDex, AHFS‑DI, Clinical Pharmacology, Lexi‑Drugs) or acceptable journals; contractors may request documentation (see 147‑151). 8) Home IVIG bundled billing (billing_rule): DME supplier bills permanent daily bundled payment for home IVIG infusions on/after 2024‑01‑01; pump not included in bundle; diagnosis ICD‑10 codes for PID required (see 179,180). 9) Home infusion supplier accreditation & plan‑of‑care requirements (prior_auth/documentation): qualified supplier accreditation required; physician‑established plan of care before services; physician/NPP signature prior to claim and periodic review; document plans, training and monitoring; bill G‑codes per infusion calendar day (see 320.3,320.5,320.8).

Background, Definitions & Evidence

This extract reiterates the Medicare statutory and contractor-level processes used for opt-out/private contract administration, and cites MAC/A/B MAC roles in determinations and claims processing. It references CMS manuals and A/B MAC processes for drug/incident-to determinations and for other program administration.

Key administrative summaries and referenced CMS processes:

- Opt-out/private contract process: statutory basis (Section 1802), affidavit and private contract requirements (content, timing, retention), 2‑year opt‑out period, automatic renewals (MACRA 2015), cancellation and early termination processes, and contractor actions when failures to maintain opt‑out are identified; contractors must notify, allow 45 days to cure, and apply consequences if unresolved [[48],[51],[63],[73]].

- Contractor system and tracking obligations: MACs must maintain opt‑out registries (name/TIN/NPI, effective/renewal/cancellation dates), notify Medicare Advantage plans and the National Supplier Clearinghouse, and implement system edits to identify opt‑out claims [[84],[85],[86],[91]].

- Claims handling and denial messaging: explicit remittance/remark codes and beneficiary MSN text required for denials of opt‑out claims (e.g., CARC 27, group PR, MA47, MA47 N771; MSN #21.19/#21.20) and requirement to use GJ modifier for emergency/urgent care by opt‑out physicians [[105],[106],[94]].

- A/B MAC roles for drug determination and self‑administered exclusion: A/B MACs (and DME MACs) individually determine 'usually self‑administered' status (>50% threshold), must publish process and exclusion lists with 45‑day notice before noncoverage, and use evidentiary criteria (peer‑reviewed literature, compendia, FDA label) [[109],[117],[118]].

- Transmittals/logs context: the chapter is maintained by a chronology of transmittals (R01BP through R13774BP and many numbered transmittals) recording manual updates, program policy changes (examples: home infusion billing guidance R10547BP effective 01‑01‑2021; MFT/MHC rules R12448BP effective 01‑01‑2024; home IVIG bundling R12352BP effective 01‑01‑2024), and other revisions — contractors and providers should consult the listed transmittals for implementation dates and CR numbers [[734],[742],[736]].

Revision History & Material Changes

2023-01-01revised

Minimum age for screening tests (FOBT 82270, G0104, G0106/G0120, and colonoscopy rules) reduced to 45 years effective January 1, 2023.

2014-01-27revised

Order requirement for FOBT expanded: for dates of service on or after January 27, 2014 attending physician assistants, nurse practitioners, or clinical nurse specialists may order screening FOBT (previously required attending physician).

2007-01-01revised

Home infusion minimum administration time>= 15 minutes per administration (pump IV or SC)

Home infusion professional availabilitySupplier must ensure services on a 7-day/24-hour basis

First-visit vs subsequent visit rule (home infusion)Higher payment for initial visit; first-visit re-billable after >60 day gap with prior discharge recorded

Certain IHS and tribal facilities and providers have special billing/payment exceptions under Part B; applicable IHS payment exceptions must be identified and documented per CMS/SMI guidance to ensure correct payment processing.

Opt-Out Applicability and Effect (40.14, 40.16-40.19)

Nonparticipating physicians/practitioners who have properly executed opt-out affidavits are not subject to Medicare billing/payment for services rendered under private contracts; claims/payment and beneficiary liability follow the opt-out rules in 40.14 and 40.16–40.19. Providers must maintain required documentation and adhere to private contract requirements.

Identification, Registration, and Systems (40.20, 40.26-40.27)

CMS/SMI systems must record opt-out status; physicians/practitioners must register and maintain identification in Medicare systems per 40.20, 40.26–40.27. Failure to register can affect payment and claims processing; plans must inform MA organizations and NSC as applicable.

Appeals and Notices (40.36, 40.38)

Appeals rights for claim determinations involving opt-out status follow CMS rules; opt-out physicians/practitioners and beneficiaries must receive claims denial notices per 40.38. Beneficiaries retain appeal rights as described in 40.36 where applicable.

Application to Medicare Advantage (40.37)

Opt-out rules and identification requirements apply to Medicare Advantage plans per 40.37; plans must be informed of opt-out physicians and how private contracting interacts with MA coverage rules.

Opt-out claims denial notices to opt-out physicians/practitioners

When a claim is denied due to opt-out status or a private contract issue, CMS/contractors must issue notice to the opt-out physician/practitioner with the reason for denial and relevant appeal rights.

Claims denial notices to beneficiaries

Beneficiaries must receive clear denial notices when services are denied because a provider has opted out, including explanation of beneficiary liability and appeal options.

Determining 'usually self-administered' (policy A–I sections)

The determination of whether a drug or biological is 'usually self-administered' follows the A–I criteria (formulation, route, administration complexity, typical setting, FDA labeling); this classification affects Part B vs Part D coverage and billing rules.

Vaccination coverage rules - Pneumococcal (50.4.4.2)

Pneumococcal vaccines are covered when furnished according to Medicare immunization coverage policies, including beneficiary eligibility, frequency and documentation requirements; providers must bill per vaccine-specific coding and payment guidance.

Vaccination coverage rules - Hepatitis B, Influenza, COVID-19

Medicare covers Hepatitis B, influenza, and COVID-19 vaccines per CMS policy when beneficiaries meet eligibility criteria; billing, administration, and payment rules (including provider settings and documentation) must be followed.

Additional Limitations for In-Home Vaccine Payment

Payment for vaccine administration in the home may be limited; in-home vaccine payment rules and additional documentation requirements apply and must be followed to avoid denial.

Off-Label Use of Drugs and Biologicals in Anti-Cancer Chemotherapeutic Regimens

Off-label uses of anti-cancer drugs/biologics may be covered when supported by medically-accepted compendia; follow the anti-cancer off-label coverage process and compendia lists.

Denial for Compounded Drugs Produced in Violation of FFDCA

Medicare will deny payment for compounded drugs produced in violation of the Federal Food, Drug, and Cosmetic Act; suppliers must comply with FFDCA and FDA guidance.

Self-Administered Drugs and Biologicals General Rule

Self-administered drugs are generally excluded from Part B coverage unless the drug is not usually self-administered, is furnished incident to a physician’s service, or otherwise meets a Part B exception; follow the self-administration determination criteria.

Immunosuppressive Drugs Coverage

Immunosuppressive drugs necessary for transplant beneficiaries may be covered under Part B (or Part D depending on status); coverage follows statutory and CMS policy requirements including timing and beneficiary eligibility.

Oral Anti-Cancer Drugs Coverage

Oral anti-cancer drugs are generally covered under Part D; coverage under Part B applies only in specific circumstances (e.g., certain separately payable drugs administered in a clinical setting) — follow program rules.

Oral Anti-Emetic Drugs Coverage

Coverage of oral anti-emetic drugs follows Part D or Part B rules depending on administration and setting; documentation and coding must reflect the applicable benefit.

Hemophilia Clotting Factors Coverage

Clotting factors for hemophilia may be covered under Part B when furnished under the appropriate clinical circumstances and by enrolled suppliers; billing and documentation requirements apply.

IVIG for Primary Immune Deficiency Diseases in the Home

IVIG furnished in the home for primary immune deficiency diseases is covered when supplier accreditation, plan of care, and documentation requirements are met; medical necessity must be demonstrated.

Home IVIG coverage under the Medicare benefit

Home IVIG coverage follows CMS rules for home infusion and DMEPOS where applicable; suppliers must meet home infusion and accreditation requirements and adhere to billing/bundling rules.

Home IVIG payment/bundling (Consolidated Appropriations Act, 2023)

Payment and bundling rules for home IVIG were updated by recent legislation; suppliers and payers must apply the current statutory payment methodology and bundling provisions in billing.

'Incident to' services and supplies (Noninstitutional setting) - Coverage requirements

Services and supplies furnished incident to a physician/NPP professional service in noninstitutional settings are covered only if all 'incident to' requirements are satisfied (physician plan of care, direct supervision when required, employed/under arrangement staffing rules, and billing conventions).

Direct personal supervision requirement (office setting)

In office settings, direct personal supervision means the physician must be present in the office suite and immediately available during provision of 'incident to' services; documentation of supervision must be maintained.

Nonphysician practitioners (services incident to physician services)

Services of NPPs furnished incident to a physician’s service follow specific coverage and billing rules; when billed by the physician, the service must meet all 'incident to' requirements including physician involvement in the plan of care.

Exception for homebound patients (permitted general supervision)

For homebound patients, Medicare permits general physician supervision for certain 'incident to' services when the physician is not physically present; documentation of homebound status and plan of care is required.

Homebound definition (Medicare home health benefit)

Homebound status is defined by CMS criteria (leaving home requires considerable and taxing effort; absences for medical treatment and short, infrequent nonmedical absences permitted). This definition affects supervision and incident-to rules.

Sleep disorder clinic - diagnostic test coverage criteria

Sleep clinics must meet CMS criteria for coverage of diagnostic tests (e.g., polysomnography) including medical necessity, physician supervision, facility accreditation, and qualified personnel performing/interpreting tests.

Specific testing notes for sleep disorders

Certain tests for sleep disorders (home sleep testing, split-night studies) have specific indications, coverage criteria, and documentation requirements; adhere to the applicable test-specific rules.

Diagnostic test supervision levels

Level of physician supervision for diagnostic tests (direct, general, personal) depends on the setting and test complexity; billing must reflect the appropriate supervision level and documentation.

Clinical laboratory services coverage requirements

Clinical labs must be CLIA-certified and meet Medicare coverage rules; specimens, ordering, and documentation requirements must be followed to ensure payment.

Bone Mass Measurement (BMM) Covered Indications

BMM is covered for specific indications (e.g., estrogen deficiency, long-term glucocorticoid therapy, monitoring). Frequency and documentation rules apply.

Requirements for Ordering Diagnostic Tests

Orders for diagnostic tests must be valid, include physician/NPP signature, and include adequate clinical information; the ordering clinician must be identified and enrolled as required.

Interpreting Physician Ordering Different Tests

If the interpreting physician determines a different or additional diagnostic test is needed, rules permit furnishing/testing only under defined circumstances; documentation and new orders may be required.

Testing Facility Furnishing Additional Tests Without New Order

Testing facilities may furnish limited additional tests without a new order only when allowed by policy and when the additional tests are consistent with the original order and patient condition; documentation of rationale is required.

Test Design / Clear Error / Patient Condition

Performing tests inconsistent with orders due to clear error or patient condition may be allowed in narrow circumstances; documentation of the exception and clinician rationale is necessary for payment.

Institution Use and Monthly Payment Rule

Equipment and supply use in institutions follows the institution use and monthly payment rules for DMEPOS; periodic payment months and institution billing rules must be followed.

No Payment Outside U.S. or Before Coverage Began

Medicare generally does not make payment for services performed outside the U.S. or prior to beneficiary’s effective coverage date unless specific exceptions apply.

Date of Service / Billing Rules for DMEPOS

DMEPOS billing must use correct date of service, adhere to initial month/periodic payment rules, and reflect institutional use when applicable.

Monthly Payment Rule for Equipment Used in an Institution

Monthly payments for equipment used while beneficiary is in an institution may be suspended or adjusted per CMS rules; suppliers must follow the institutional use rules to avoid improper payments.

Clinical Social Worker (CSW) Services - Covered

CSW services are covered when furnished by qualified CSWs within scope of practice and when services meet medical necessity and documentation requirements.

Clinical Social Worker (CSW) Services - Not Covered

Services by unqualified personnel or services not meeting medical necessity or scope are not covered; documentation deficiencies can lead to denial.

CSW & Outpatient Mental Health Services Limitation

Medicare places limitations on outpatient mental health visits and payment rates; providers must follow billing and frequency limits.

Nurse-Midwife (CNM) Services - Covered

CNM services are covered when furnished by qualified CNMs in accordance with state scope and Medicare rules; certain maternity and newborn services have specific billing provisions.

Nurse-Midwife - Incident To and Documentation

CNM services billed incident to a physician must meet 'incident to' requirements including physician plan of care and appropriate supervision/documentation.

Nurse-Midwife - Not Covered

Services outside CNM scope or lacking medical necessity or proper documentation are not covered.

Physician Assistant (PA) Services - Qualifications and Covered Services

PAs are covered when appropriately trained and licensed; covered services include evaluation and management, procedures, and other services in accordance with state law and CMS rules.

PA - Incident To, Documentation, Billing

When PA services are furnished incident to a physician, all incident-to rules apply; billing, documentation, and physician oversight must be present where required.

PA - Not Covered

PA services outside scope, lacking supervision, or without necessary documentation may be denied.

Nurse Practitioner (NP) Services - Qualifications and Covered Services

NP services are covered when the NP meets state and CMS qualifications; services include assessment, management, and certain procedures per scope of practice.

NP - Incident To, Documentation, Billing

NP services furnished incident to a physician must meet incident-to criteria for the physician to bill; otherwise NPs may bill directly as permitted.

NP - Collaboration

NP collaboration or supervisory arrangements vary by state; Medicare requires appropriate supervisory documentation where applicable.

Clinical Nurse Specialist (CNS) Services - Qualifications and Covered Services

CNS services are covered when delivered by qualified CNS providers and meet medical necessity and documentation requirements.

CNS - Incident To, Documentation, Billing

CNS services furnished incident to a physician follow incident-to rules if billed by the physician; documentation of supervision and plan of care required.

Outpatient Therapy - Key Definitions and Operational Rules

Outpatient therapy (PT/OT/SLP) coverage is governed by definitions of medically necessary skilled therapy, documentation of functional improvement potential, and other operational rules including therapy caps or thresholds where applicable.

Outpatient Therapy - Providers, Clinicians, Qualified Personnel

Therapy services must be furnished by qualified providers and clinicians (PT, OT, SLP) or under appropriate supervision by assistants where allowed; provider qualifications must be documented.

General Conditions for Coverage

Outpatient therapy must meet general coverage conditions: physician plan of care, documentation of medical necessity, measurable improvement, and appropriate coding.

Conditions for Maintenance Program Coverage

Maintenance therapy (nonimproving) is generally not covered unless meeting specific criteria demonstrating medical necessity and documented clinician rationale per policy.

Documentation Requirements for Payability

Therapy claims require sufficient documentation of evaluation, treatment plan, progress notes, and functional outcomes to support medical necessity and payment.

Functional Reporting (historical: 2013-2018)

Functional reporting requirements (G-codes) applied historically; providers should follow current CMS functional reporting rules if applicable to dates of service.

Personnel Qualifications and Supervision

Therapy providers must ensure personnel meet state licensure/certification and CMS supervision requirements for assistants or contracted therapists.

General Coverage / Qualified Provider Requirements

Providers furnishing services under Medicare must be enrolled, meet credentialing/enrollment rules, and render services within their scope of practice.

Qualified Occupational Therapist / Occupational Therapy Assistant (OT/OTA) Eligibility

OTs and OTAs must meet state licensure and CMS qualifications; OTA supervision requirements apply and must be documented.

Qualified Physical Therapy Assistant (PTA) / PT Support Personnel

PTAs and support personnel may furnish components of therapy under PT supervision per state law and CMS rules; supervising PT must document oversight.

Qualified Speech-Language Pathologist (SLP) and Assistants

SLPs and qualified assistants must meet licensure/certification and CMS supervision standards; billing must reflect the qualified provider for payable services.

Speech-Language Pathology Coverage: Evaluation and Treatment

SLP evaluations and treatments must be medically necessary, documented, and furnished by qualified SLPs; certain preventive or maintenance services may not be covered.

Therapist in Private Practice (TPP) Rules

TPPs must be enrolled in Medicare and meet documentation, supervision, and billing rules specific to private practice settings for therapy services to be payable.

Incident-to Therapy Services (Physician/NPP)

Therapy services billed incident to a physician or NPP must meet incident-to requirements including physician-established plan of care, direct supervision when required, and documentation of physician involvement.

Outpatient therapy furnished under arrangements - general contract requirements

When therapy is furnished under arrangement, contracts must meet CMS requirements, ensure qualified personnel, and preserve billing and documentation responsibilities.

Hospital special rules for outpatient therapy billing

Hospitals have special billing rules for outpatient therapy (facility vs professional claims, site-of-service billing restrictions); follow hospital-specific guidance.

Limits on hospital billing in certain settings

Hospitals may be limited in billing outpatient therapy in certain off-campus or distinct-part settings per CMS rules; verify site-specific billing policy.

Pulmonary Rehabilitation (PR) - Covered Conditions and Program Components

PR is covered for specified pulmonary diagnoses when programs meet CMS-defined components, qualified personnel, and documentation of medical necessity and outcomes.

Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) - Covered Conditions and Program Components

CR and ICR are covered for specified cardiac conditions with program components, qualified staff, and outcomes reporting; adhere to frequency and session limits.

Services to inpatients of hospitals and SNFs covered under Part B

Certain physician services to inpatients of hospitals/SNFs are covered under Part B; billing and service rules depend on inpatient/outpatient classification and Medicare regulations.

Ambulatory Surgical Center (ASC) services

ASCs may furnish and bill for covered procedures appearing on the ASC list when all ASC coverage conditions are met and facility-level payment rules are followed.

ASC Facility Services - Covered When ALL of the Following are Met

ASC facility services are covered when: the procedure is on the ASC list, patient selection criteria are met, appropriate monitoring and safety requirements are present, and state licensure/accreditation apply.

ASC Non-Facility Services (Payable Separately) - Examples (ANY of)

Certain professional services, supplies, and devices may be payable separately when furnished in the ASC if they meet criteria for separate payment (e.g., anesthesia, intraoperative imaging) — follow code-level guidance.

ASC Covered Items Included in Facility Payment (ANY of)

Many items and supplies are bundled into the ASC facility payment; only items meeting separate-pay criteria are billed separately.

ASC List Inclusion Rules (ALL of)

To be performed in an ASC and paid, a procedure must be on the ASC list and meet ASC program criteria for safety and resource use.

Glaucoma Screening - Covered When ALL of the Following are Met

Glaucoma screening coverage requires beneficiary risk factors and medical necessity per CMS criteria; routine population screening may not be covered without risk factors.

Colorectal Cancer Screening - Coverage Criteria (by test/procedure)

Colorectal screening tests (colonoscopy, FIT, sigmoidoscopy, etc.) are covered per screening frequency, high-risk criteria, and age rules. Follow test-specific coverage guidance.

Determination of High Risk for Colorectal Cancer (ANY of)

Personal or family history of colorectal cancer or adenomatous polyps
Inflammatory bowel disease (ulcerative colitis or Crohn's disease)
Known genetic syndromes predisposing to colorectal cancer (e.g., FAP, Lynch syndrome)

Screening Barium Enema Minimum Age

Screening barium enema coverage follows age and clinical criteria; check current guidance for minimum covered ages and intervals.

Screening Pap Smear Coverage Frequency and High-Risk Criteria

Pap smear coverage follows frequency guidelines and high-risk categories; documentation of symptoms or high-risk status influences coverage.

Foot Care Coverage and Exclusions

Routine foot care is generally not covered unless medically necessary and related to a systemic condition (e.g., diabetes) with documentation supporting the need for skilled podiatric care.

Noncovered Colorectal Screening Codes

Certain colorectal screening codes or uses may be noncovered; refer to code-level CMS guidance to identify noncovered services.

Foot Care Diagnostic/Complicating Condition Payment

Foot care may be covered and payable when related to complicating conditions; document the condition and necessity for treatment beyond routine care.

Diabetes Self-Management Training (DSMT) - Coverage and Provider Requirements

DSMT is covered when provided by qualified programs and instructors, with beneficiary eligibility documented and sessions meeting CMS content and outcome requirements.

DSMT - Beneficiary Eligibility and Definition of Diabetes

Beneficiaries must meet CMS definitions of diabetes and related conditions to qualify for DSMT; documentation of diagnosis and physician orders is required.

DSMT - Frequency and Unit Limits

DSMT frequency and unit limits apply (initial and follow-up sessions); prior training history and documentation affect allowable sessions.

DSMT - Incident-To and Billing Requirements

When DSMT is furnished incident to a physician, incident-to rules apply for billing; otherwise, DSMT programs bill per program enrollment and credentialing rules.

KDE - Qualified Providers and Exclusions

Kidney disease education (KDE) providers must meet qualification standards; exclusions apply for unqualified personnel or services not meeting program requirements.

KDE - Limitations and Coding

KDE services have limitations on frequency and specific coding requirements; document education content and outcomes.

KDE - Standards for Content and Outcomes Assessment

KDE programs must follow CMS standards for content and measure outcomes per program rules to ensure continued coverage.

Home Infusion Therapy Services - Benefit Overview and Scope

Home infusion therapy coverage includes professional services, supplies, and drugs when furnished by accredited suppliers under a plan of care and meeting CMS home infusion requirements.

Home Infusion Therapy - Supplier and Accreditation Requirements

Home infusion suppliers must be accredited and meet supplier standards; nonaccredited suppliers risk denial of home infusion claims.

Home Infusion Therapy - Plan of Care Requirements

A physician-established plan of care, documentation of training, monitoring, and qualified personnel involvement are required for home infusion payment.

Home Infusion Therapy - Notification and Coordination

Suppliers must notify and coordinate with ordering clinicians and caregivers per CMS rules; timely communication and documentation are required.

Home Infusion Therapy - Professional Services Requirements

Professional services (e.g., nursing, pharmacology oversight) associated with home infusion must be documented and furnished by qualified personnel to be payable.

Covered Home Infusion Therapy Professional Services

Covered services include initial assessment, training, monitoring, and other professional services defined in CMS home infusion policies when documented and justified.

Home Infusion Therapy Training and Education Requirements

Training for beneficiaries/caregivers on infusion therapy must be documented in the plan of care and fulfill CMS competency requirements for payment.

Payment and Billing Conditions for Home Infusion Therapy Services

Home infusion billing must follow CMS bundling, billing codes, and payment conditions including drug vs supply payment rules and possible periodic payment adjustments.

Coverage Criteria for MFT and MHC Services

Marriage and family therapy (MFT) and mental health counselor (MHC) services are covered only when furnished by qualified providers in states where recognized and when meeting Medicare coverage criteria; documentation and enrollment rules apply.

Teaching Physician Payment under Part B: Payment conditions: teaching physician (attending) must personally review H&P, personally examine patient timely after admission, confirm/revise diagnoses, determine treatment plan, assure supervision, make frequent reviews; medical record must contain signed/countersigned notes evidencing these actions; for resident-rendered services, teaching physician must be present during key portion or repeat key portions with own documentation to be paid.

Private Contracts and Opt-Out (Section 1802) and related procedures

Grouped criteria covering opt-out/private contract rules, affidavit, maintenance, failure-to-maintain, contractor actions, registration, cancellation, appeals, MA application — preserve stepwise conditions, cure periods, and consequences.

Private Contracts and Opt-Out (Section 1802) - Valid Private Contract Requirements: A private contract must be in writing, legible, state exclusion status if applicable, state beneficiary accepts full payment responsibility and understands Medicare limits do not apply, agree not to submit claim to Medicare, state Medicare will not pay; state beneficiary understands right to seek non-opt-out providers; state effective and expiration dates of 2-year opt-out period; state Medigap notice; be signed by beneficiary and physician; provided before services; retained by physician for opt-out period and available to CMS; must not be entered during emergency/urgent care for that encounter.

Opt-Out Affidavit Requirements: Affidavit must be written and signed by physician/practitioner; contain full name, address, phone, NPI or billing number or TIN if no NPI; state that except for emergency/urgent care during opt-out period physician will provide services only by private contracts meeting §40.8; state physician will not submit claims to Medicare nor permit others to submit claims for services during opt-out (except emergency/urgent); acknowledge may receive no Medicare payment directly or indirectly; attest that participation agreement terminates on effective date if applicable; filed with all MACs with jurisdiction; initial 2-year period begins on signature date if filed within 10 days after signing first private contract.

Automatic Renewal under MACRA: Valid opt-out affidavits signed on/after June 16, 2015 automatically renew every 2 years; physicians may cancel renewal by notifying contractors in writing at least 30 days prior to next opt-out period start; affidavits signed before June 16, 2015 expire 2 years after effective date and require renewal within 30 days after expiration to extend opt-out.

Consequences of Failure to Properly Opt-Out: If private contracts entered before filing affidavit or affidavit not filed per §40.9, attempt to opt-out nullified and private contracts deemed null/void; physician must submit claims to Medicare for covered items/services furnished and is subject to limiting charge provisions; may not bill/collect amounts except deductible/coinsurance; may attempt to opt-out again.

Failure to Maintain Opt-Out (40.11) - Events Constituting Failure: A physician/practitioner fails to maintain opt-out if during the opt-out period any of: knowingly and willfully submits a claim for Medicare payment or receives Medicare payment for covered services (except emergency/urgent); fails to enter into private contracts or enters into noncompliant private contracts; fails to comply with emergency/urgent billing provisions; fails to retain copies of private contracts for duration of current 2-year period or permit CMS inspection.

Consequences When Violation Discovered by Medicare Contractor (40.11.B): If failure to maintain opt-out found and not remedied within 45 days, effective day 46 for remainder of opt-out period: all private contracts deemed null/void; opt-out nullified; physician must submit claims to Medicare for all covered items/services; physician/practitioner or beneficiary will not receive Medicare payment on Medicare claims for remainder of opt-out period except as stated; physician subject to limiting charge provisions; cannot reassign claims except as provided; may neither bill nor collect any amount from beneficiary except deductible/coinsurance; may not attempt to opt out again until current 2-year period expires.

Consequences When Violation Not Discovered During 2-Year Period (40.11.C): If violation not discovered during period, the same sanctions apply from date of first violation until end of 2-year period unless corrected within 45 days of notice or discovery by taking good faith efforts (e.g., refunding excess amounts).

Medicare Contractor Actions on Potential Failure to Maintain Opt-Out (40.12): When potential failure identified, contractor must send letter describing believed situation and request explanation and plan to resolve within 45 days; request emergency/urgent documentation if applicable or explanation if filed in error; request corrective action/timeline for systems problems; if no response assume no correction and that effects of failure to maintain opt-out apply; if claim filed in error and physician indicates error contractor continues processing then denies and notifies beneficiary; if physician knowingly/ willfully failed to maintain opt-out or no response notify physician that §40.11 effects apply.

Opt-Out Applicability and Effect (40.14,16-19): Initial 2-year opt-out begins on affidavit signature date if filed within 10 days after first private contract; excluded physicians may opt-out but exclusion date takes precedence; participation agreements terminate on opt-out effective date; physicians may not partially opt-out; suppliers (DMEPOS, labs, IDTFs) cannot opt out; private contracts not needed for categorically noncovered items.

Emergency and Urgent Care Exceptions and Billing (40.28-40.29): Payment may be made for emergency/urgent care furnished by opt-out physician who has not signed private contract with beneficiary; opt-out physician treating such beneficiary may not charge more than Medicare limiting charge (physician) or deductible/coinsurance (practitioner) and must submit claim to Medicare on beneficiary's behalf; physician may take assignment or not; claim must include appropriate HCPCS code and GJ modifier indicating emergency/urgent services by opt-out physician without private contract; failure to submit GJ requires contractor deny claim so beneficiary can appeal; for emergency procedure with post-op follow-up use GJ and 54 modifiers to bill procedure ensuring E/M not paid in global; follow-up non-urgent care requires private contract or referral to Medicare physician; if beneficiary continues to need emergency/urgent care payment continues until no longer needed; contractor may accept modifiers and do post-pay records review for frequent users.

Identification, Registration, and Systems (40.20,40.26-40.27): Contractor must maintain name, TIN, opt-out effective date, and automatic renewal date for affidavits filed on/after 2015-06-16; maintain opt-out end/cancellation dates if canceled; use NPI if available else TIN to identify opt-out physicians nationwide; system must automatically identify claims including opt-out providers and must not pay opt-out physicians for services on/after opt-out effective date unless emergency/urgent exception applies; contractor must notify NSC of opt-out physicians (web site not acceptable).

Cancellation, Early Termination, and Renewal (40.33-40.35): Physician may cancel opt-out by submitting written notice to each MAC no later than 30 days before end of current 2-year opt-out period; opt-out may be terminated within 90 days of effective date if physician: has not previously opted out, notifies all MACs no later than 90 days after effective date, refunds amounts collected in excess of limiting charge/deductible & coinsurance to beneficiaries, and notifies beneficiaries of right to have claims filed for services furnished between opt-out effective date and termination effective date; when properly terminated and physician previously enrolled, physician reinstated in Medicare as if no opt-out.

Appeals and Notices (40.36,40.38): CMS determinations about failures in opt-out processes are initial determinations for appeals; determinations that no payment can be made to beneficiary for services of opted-out physician are initial determinations; contractor must use specific CARCs and RARCs when denying claims from opt-out physicians (e.g., CARC 27 with group PR and remark MA47 or MA47 N771) and include specified denial messages; contractor must use specified MSN messages for beneficiary notices (MSN #21.20 or #21.19).

Prior Authorization

Opt‑out / private contract filing, affidavit & retention requirements

Providers who opt out must file and maintain an opt-out affidavit and keep private contracts on file for the entire 2‑year opt‑out period. Affidavit requirements include written, signed statement with full name, address, telephone, NPI or TIN, statement that except for emergency/urgent care they will provide Medicare beneficiaries services only via private contracts, that they will not submit Medicare claims or receive Medicare payment for those services, and acknowledgement that their Part B participation agreement terminates on the affidavit effective date. Valid affidavits filed on/after 2015‑06‑16 automatically renew every 2 years unless cancelled in writing at least 30 days prior to the next period. Private contracts must be written, clearly legible, specify beneficiary acceptance of full payment responsibility and agreement not to submit Medicare claims, list the opt‑out effective and expiration dates (the standard opt‑out period is 2 years), be provided to beneficiaries before services are furnished, and be retained by the physician for the duration of the current 2‑year period and made available to CMS on request. If a contractor alleges failure to maintain opt‑out, the physician/practitioner has 45 days to demonstrate cure (good faith efforts), otherwise after day 46 the opt‑out and private contracts are nullified and the physician must submit claims to Medicare and is subject to limiting charge provisions. Physicians seeking early termination must notify all MACs within 90 days of the affidavit effective date and refund any amounts collected in excess of limiting charge/deductible & coinsurance.

Affidavit must include full name, address, phone, NPI or TIN, and required declarations (see §40.9)
Private contracts: written, legible, state beneficiary accepts full payment responsibility and will not submit claim to Medicare, state opt‑out 2‑year effective/expiration dates, note Medigap implications, signed by beneficiary and physician, provided before services, retained by physician for 2‑year period (see §40.8)
Affidavits filed on/after 2015‑06‑16 auto‑renew every 2 years; cancel renewal by notifying all MACs ≥30 days prior to next period (see §40.2)
Contractor sends development letter and physician has 45 days to respond/ cure; failure to cure → effects described in §40.11 apply (45‑day cure period)
Early termination window: physician may terminate opt‑out within 90 days of effective date if conditions met (notify MACs, refund overcharges) (see §40.35)

Billing Rule

Consultation CPT coding change (99241‑99245 & 99251‑99255)

Medicare no longer recognizes CPT consultation codes for outpatient payment as of 2010. To report services that would have used consultation codes, bill the appropriate new or established patient office/outpatient E/M codes or the appropriate hospital/nursing facility care codes instead. The consultation CPT ranges referenced in prior policy are CPT 99241–99245 and 99251–99255; contractors and providers should use appropriate E/M codes per Pub.100‑04 instructions.

Do not bill CPT 99241‑99245 or 99251‑99255 for Medicare outpatient consultations after 2010
Use appropriate new/established patient E/M CPT codes or hospital/nursing facility E/M codes instead

Documentation Required

Care Plan Oversight (CPO) documentation & 30‑minute timekeeping

Care Plan Oversight (CPO) requires physician documentation of services furnished and the date and length of time. To bill CPO the physician must provide at least 30 minutes of CPO within the calendar month claimed and must have provided a face‑to‑face E/M encounter within the prior 6 months (only E/M services qualify). Time spent by nurses or consulting with nurses does not count toward the 30 minutes, and services billed incident‑to or included in other E/Ms/global surgical care do not count. Maintain contemporaneous documentation of date, service details and time.

Minimum physician time: ≥30 minutes per calendar month
Prerequisite: face‑to‑face E/M by physician or NPP within prior 6 months
Document services furnished, dates, and length of time in the patient's medical record

Documentation Required

Teaching physician presence and documentation requirements

Teaching physician rules: to bill under Part B a teaching physician must be present for the key portion of services performed by a resident; if the resident saw the patient without the teaching physician present, the teaching physician must repeat the key portions and document their own findings. Medical records must contain signed or countersigned physician notes showing personal review of diagnoses, visits at critical times, and discharge documentation. Qualified nonphysician practitioners may review and verify (sign and date) rather than re‑document team notes for Part B services.

Teaching physician must be present during key portion of resident‑performed service or repeat key portions and document independently
Medical record must include signed/countersigned physician notes evidencing personal review and visits at critical times
NPPs (e.g., NP, PA) may review and verify rather than re‑document team notes for Part B services

Billing Rule

Emergency/urgent care billing rules for opt‑out physicians (GJ and use of 54)

For emergency/urgent care furnished by an opt‑out physician without a private contract, claims must include the GJ modifier to indicate emergency/urgent services by an opt‑out physician and may include modifier 54 when billing surgical care only so E/Ms in the global fee are not paid. Opt‑out physicians treating such beneficiaries must limit charges to the Medicare limiting charge (physicians) or collect only deductible/coinsurance if taking assignment (practitioners). Failure to submit GJ will cause contractor denial to enable beneficiary appeal.

Use modifier GJ on claims for emergency/urgent services by an opt‑out physician without a private contract
Use modifier 54 when applicable (e.g., surgical care only) alongside GJ to prevent payment of global E/M
Limit charges to Medicare limiting charge (physician) or collect only deductible/coinsurance if taking assignment

Advance Care Planning (ACP) with AWV: ACP is optional AWV element when furnished same day by same provider; when part of AWV coinsurance/deductible waived; ACP is face-to-face service discussing advance directives; report per CPT/MPFS rules when applicable.

Vaccination Coverage Rules - Pneumococcal: Pneumococcal vaccine coverage aligned with ACIP: adults >=65 and adults 19-64 with certain conditions should receive 1 dose PCV (PCV20 or PCV15) if not previously received; when PCV15 used follow with PPSV23 interval >=1 year (8 weeks may be considered for high-risk); adults who only received PPSV23 may receive PCV >=1 year after last PPSV23; effective July 1, 2021 updates; reliance on patient verbal history for prior vaccination acceptable; physician order not required.

Vaccination Coverage Rules - Hepatitis B, Influenza, COVID-19 and In-Home Payment: Hepatitis B: effective Jan 1, 2025 Part B covers hepatitis B vaccine/admin for beneficiaries at high/intermediate risk groups (lists provided); ESRD vaccine admin paid separate from composite rate. Influenza: effective May 1, 1993 Part B covers influenza vaccine once per season; physician order not required. COVID-19: effective Nov 2, 2020 Part B covers COVID-19 vaccines and administration; effective June 8, 2021 additional in-home admin payment initially temporary extended and made permanent Jan 1, 2024 for preventive vaccines including COVID-19/pneumococcal/influenza/hepatitis B when conditions met.

COVID-19 and Other Preventive Vaccine In-Home Additional Payment: Additional in-home payment payable when: patient has condition restricting ability to leave home or faces barriers; or sole purpose of visit is vaccine admin; home is non-institutional residence; furnisher documents clinical status/barriers; no additional amount if another Medicare-covered service furnished same home/date; only one additional payment per patient per home visit; report per Claims Processing Manual.

Colorectal Cancer Screening - FOBT (82270/G0328): Screening FOBT (gFOBT 82270 or immunoassay G0328) covered frequency once every 12 months (>=11 months), requires written order from attending physician; as of Jan 27, 2014 order may be from attending PA/NP/CNS; effective Jan 1, 2023 minimum age reduced to 45 years.

Colorectal Cancer Screening - Flexible Sigmoidoscopy (G0104): Covered for beneficiaries age >=50 (reduced to >=45 effective Jan 1, 2023) when performed by MD/DO or PA/NP/CNS; frequency once every 48 months (>=47 months); if beneficiary not high risk and had screening colonoscopy G0121 within preceding 10 years then G0104 covered only after >=119 months since last G0121; written order required.

Colorectal Cancer Screening - Screening Colonoscopy High Risk (G0105): A/B MAC must pay when performed by MD/DO for beneficiaries at high risk; frequency once every 24 months (>=23 months); if lesion found requiring biopsy/removal bill diagnostic colonoscopy with biopsy/removal instead; effective Jan 1, 2023 follow-on colonoscopy after positive non-invasive stool-based test covered and frequency limits do not apply.

Colorectal Cancer Screening - Screening Colonoscopy Not High Risk (G0121): Covered when individual not high risk; frequency once every 10 years (>=119 months); if beneficiary had covered flexible sigmoidoscopy G0104 then G0121 covered only after >=47 months following last G0104; if lesion found requiring biopsy/removal bill diagnostic colonoscopy with biopsy/removal rather than G0121; effective Jan 1, 2023 follow-on colonoscopy after positive stool-based test covered without frequency limits.

Colorectal Cancer Screening - Barium Enema (G0106/G0120): Covered as alternative to screening sigmoidoscopy or colonoscopy with same frequency parameters (47 months routine, 23 months high-risk); screening barium enema must be ordered in writing after determination it's appropriate (double contrast generally); effective Jan 1, 2023 minimum age reduced to 45 years.

Determining High Risk for Colorectal Cancer: An individual is high risk if any of: close relative with colorectal cancer or adenomatous polyp; family history of familial adenomatous polyposis; family history of hereditary nonpolyposis colorectal cancer; personal history of colorectal cancer; personal history of adenomatous polyps; inflammatory bowel disease including Crohn's disease and ulcerative colitis.

Colorectal Screening Follow-On after Positive Non-Invasive Stool Test (Effective Jan 1, 2023): Follow-on screening colonoscopy after positive non-invasive stool-based test (gFOBT 82270, iFOBT G0328, or multi-target stool DNA 81528) is covered and not subject to routine frequency limits for both high-risk and non-high-risk screening colonoscopy codes.

Billing Rule

Reporting G0136 with Modifier‑33 when furnished as AWV element

When HCPCS G0136 (SDOH Risk Assessment) is furnished as an element of an Annual Wellness Visit (AWV), report G0136 with Modifier ‑33 on the same claim and same date of service as the initial AWV (G0438) or subsequent AWV (G0439) to be separately payable without cost sharing. If G0136 is billed without Modifier‑33 it will be processed as furnished in conjunction with an E/M or behavioral health visit with applicable patient deductible/coinsurance.

Report G0136 + Modifier ‑33 on same claim/date as G0438 or G0439 when SDOH assessment is AWV element
G0136 without ‑33 processed as in conjunction with E/M/behavioral health (patient cost sharing applies)

Documentation Required

In‑home vaccine additional payment documentation & limits

For the in‑home additional vaccine payment, document in the medical record the beneficiary's clinical status or barriers preventing vaccination outside the home; homebound certification is not required. Only one additional in‑home payment is allowed per patient per home visit even if multiple vaccines are administered; each vaccine still receives its own administration payment. The sole purpose of the visit must be vaccine administration for the additional payment to apply.

Document clinical status or barriers that prevent vaccination outside the home (no homebound certification required)
Only one additional in‑home payment per patient per home visit even with multiple vaccines
Sole purpose of the visit must be vaccine administration to qualify for the additional payment

Incident-to requirements (50.3): To meet incident-to coverage all must be satisfied: drug/biological is of form not usually self-administered; furnished by a physician; administered by physician or auxiliary personnel employed by physician under physician's personal supervision; drug charge included in physician's bill and represents expense to physician.

Reasonable and necessary exclusions (50.4.3): Examples where medication not reasonable/necessary: given for general welfare not a particular illness (e.g., vitamins); injection method not indicated when oral form accepted unless special circumstances; medications exceeding frequency/duration per accepted standards (e.g., B12 maintenance more than 1/month without justification).

Drugs treated as hospital outpatient supplies (M): Drugs may be treated as supplies when integral to or directly related to a procedure (e.g., sedatives pre-op, ocular drops given immediately before/during/after ophthalmic procedure, contrast media integral to imaging, topical solutions used with photodynamic therapy, antibiotic ointments placed at completion). Examples NOT treated as packaged supplies include drugs given for continued home use, routine meds given pre-op, oral pain meds for unrelated issues, laxatives while waiting for unrelated X-ray.

Vaccination rules (see 50.4.4.2 for pneumococcal/hepatitis B/influenza/COVID) and in-home vaccine payment: Vaccinations generally excluded unless related to treatment of injury/exposure with exceptions for pneumococcal/hepatitis B/influenza/COVID-19; pneumococcal ACIP-aligned rules effective July 1, 2021 with PCV15/PCV20 guidance and intervals; hepatitis B coverage Jan 1, 2025 for high/intermediate risk groups; influenza covered May 1, 1993 once per season; COVID-19 covered Nov 2/Dec 11 2020; in-home additional payment payable when conditions met (patient difficulty leaving home, sole purpose visit, home not institutional, document barriers) and only one additional payment per visit.

Off-Label Use of Drugs in Anti-Cancer Regimens: Off-label uses may be covered if medically accepted and supported by listed compendia or peer-reviewed literature; regiment defined as combination of anti-cancer agents for specific cancer; contractor may request compendia or literature documentation; uses identified as not indicated by CMS/FDA or listed as unsupported in compendia or contradicted by peer-reviewed literature are not covered.

Compendia Acceptance Criteria: A use is medically accepted by compendia if ANY of: NCCN Category 1 or 2A; DrugDex Class I, IIa, IIb; AHFS-DI or Clinical Pharmacology narrative supportive; Lexi-Drugs 'Use: Off-Label' with Evidence Level A. Not accepted if any of: NCCN Category 3; DrugDex Class III; AHFS/Clinical Pharmacology 'not supportive'; Lexi-Drugs 'Use: Unsupported'.

Peer-Reviewed Literature Support for Off-Label Use: Contractors may accept peer-reviewed clinical research if evidence adequately represents beneficiary/cancer characteristics, regimen is adequately represented, outcomes are clinically meaningful, study design appropriate (non-randomized trials with substantial subjects may support; case reports generally inadequate); acceptable journals list provided; abstracts and industry in-house publications excluded.

Process for Amending List of Compendia: CMS provides annual 30-day open request period starting Jan 15 for public submissions; complete requests posted by March 15, public comment 30 days; CMS may generate urgent requests; request must include contact, compendium identification, copy/access, requested action, documentation of compliance with rule conditions, public transparent processes and COI disclosures; decisions published within 90 days after close of public comment.

Less Than Effective Drug and Denial for Illegally Compounded Drugs: Drugs FDA-determined to lack substantial evidence of effectiveness for all labeled indications are 'less than effective' and not payable; when FDA determines a firm produces compounded drugs in violation of FFDCA Medicare does not pay for those drugs and related DME/prosthetic devices used to administer them; CMS will notify A/B MAC when FDA determines violations.

EPO coverage and Procrit preoperative use

EPO coverage and monitoring criteria for dialysis patients and Procrit preoperative use note — include prerequisites, monitoring, on-hand supply limit (<=2 months), hematocrit thresholds.

Erythropoietin (EPO) Coverage for Dialysis Patients: EPO covered for anemia in dialysis patients when administered in renal dialysis facility or self-administered at home by competent dialysis patient/caregiver meeting conditions: current care plan for monitoring home EPO use (diet/fluid review, med review for supplemental iron, ongoing Hct and iron monitoring, dialysis prescription reevaluation, physician/facility follow-up on blood tests, patient training to identify hypotension/hypertension, plan for decrease/discontinuance if hypertension uncontrollable); preselection monitoring: Hct/Hgb, serum iron, transferrin saturation, ferritin, BP; patient selection: dialysis patient with Hct <=30% to initiate (unless documented clinical justification), ongoing between 30-36% if already receiving EPO; patient/caregiver trained in injection, aseptic technique, reading labeling; EPO stored under refrigeration at home and kept safe; physician/facility responsibilities include protocol following label, ensure on-hand drug <= 2-month supply, maintain QA records and provide records for backup facility; claims must include hematocrit readings and specified clinical data.

Procrit Preoperative Use (Note): A/B MAC may determine Procrit covered preoperatively for selected patients meeting all: undergoing hip or knee surgery; have anemia with hemoglobin between 10 and 13 mg/dL; not candidate for autologous blood transfusion; expected to lose >2 units blood; had workup showing anemia appears chronic disease. Coverage discretionary by MAC.

Home Infusion Therapy: suppliers, eligibility, plan of care, services, qualifying drugs and payment rules

Home infusion therapy: supplier qualifications, patient eligibility, plan of care requirements, professional services, training/education, monitoring, qualifying home infusion drugs, payment/bundling rules including permanent bundled payment effective 2021 (and IVIG bundling effective 2024 noted elsewhere). Payment contingent on DME drug billing, unit of single payment per infusion drug admin calendar day and 15-minute time increments; first-visit vs subsequent rules; medical review triggers.

Home Infusion Therapy - Benefit Overview: Home infusion therapy benefit covers professional services (including nursing), patient training/education (not DME), remote monitoring and monitoring services for eligible home infusion drugs administered IV or subcutaneously for >=15 minutes in the patient's home via a DME pump; benefit separate from DME drug/supply coverage.

Qualified Home Infusion Therapy Supplier Requirements: Qualified supplier must be a pharmacy, physician, or other provider/supplier licensed by State; furnish services to individuals with acute or chronic conditions requiring home infusion drugs; ensure safe/effective provision on 7-day/24-hour basis; be accredited by organization designated by Secretary and meet other requirements; may subcontract with pharmacy/physician/other qualified supplier.

Patient Eligibility and Location: Beneficiary must have Medicare Part B; be under care of applicable provider (physician/NP/PA); be under physician-established plan of care meeting 42 CFR 414.1515 and 486.520; services must be furnished in patient's home (place of residence per 1861(n)) excluding hospitals, CAHs, SNFs.

Plan of Care Requirements: Plan must prescribe type, amount, duration of home infusion therapy services; specify medication/dosage/frequency and professional services; physician orders must specify frequency and discipline; plan must be signed and dated by ordering physician prior to claim submission and upon any changes; plan must be periodically reviewed by physician in coordination with home infusion drug furnishing; physician must consult with DME supplier and home infusion therapy supplier when establishing/reviewing plan; physician must notify beneficiary of available infusion therapy options and document discussion.

Professional Services and Training: Qualified supplier must provide on 7-day/24-hour basis: professional services including nursing; patient training and education not covered under DME (hygiene and vascular access care, medication/disease management, assessment/evaluation); remote monitoring and monitoring services; services must be in accordance with nationally recognized standards and state/federal laws; skilled professional services on infusion drug administration day must be inherently complex and only safely performed by/under supervision of professional/technical personnel.

Remote Monitoring and Monitoring Services: Monitoring required as part of plan: ongoing patient monitoring and reassessment for response, complications, adverse reactions, compliance; plan specifies evaluation intervals for patient-reported responses, infusion complications, pump rate verification, labs, vitals; direct communication and coordination with patient/caregivers/clinicians; remote monitoring via phone/electronic communication permitted with patient instruction on vitals and equipment use; off-site monitoring allowed if safe, appropriate, secure.

Qualifying Home Infusion Drugs: A home infusion drug qualifies when: drug is parenteral and administered IV or subcutaneously for >=15 minutes through a pump that is DME covered under Part B; drug necessary for effective use of DME infusion pump and reasonable/necessary; requires infusion through external infusion pump (drugs that can be infused via disposable pump or gravity drip do NOT qualify); not an insulin pump system drug and not on self-administered exclusion list; drugs identified in DME LCD L33794 qualify if infused IV or subcutaneously over >=15 minutes and not excluded.

Payment and Billing Conditions: Payment is a single bundled payment per infusion drug administration calendar day per payment category contingent on corresponding home infusion drug being covered/paid under DME; DME supplier must bill appropriate drug no more than 30 days prior to home infusion therapy service visit; drugs assigned to payment categories by HCPCS J-code; supplier must submit appropriate G-code line-item for each infusion drug administration calendar day and include length of professional services furnished in 15-minute increments; payment only on days professional services provided in home; first-visit payment higher than subsequent visits; to bill first-visit again after discharge must have >60 day gap with no G-code billed and last G-code shows discharge; first-visit may be billed day 61.

Medical Review Triggers: Payments may be subject to medical review adjustment based on beneficiary eligibility, plan of care requirements, and medical necessity determinations.

Documentation Required

Compendia / peer‑review evidentiary requirements for off‑label anti‑cancer coverage

Off‑label anticancer drug uses are considered medically accepted when supported by specified compendia (e.g., NCCN Category 1 or 2A; DrugDex Class I/IIa/IIb; supportive narrative in AHFS‑DI/Clinical Pharmacology; Lexi‑Drugs 'Off‑Label' with Evidence Level A) or by acceptable peer‑reviewed clinical research meeting evidentiary criteria. Contractors may request compendia or peer‑reviewed literature documentation from the treating physician to determine medical acceptance.

Compendia evidence acceptable: NCCN Category 1/2A, DrugDex Class I/IIa/IIb, supportive AHFS‑DI/Clinical Pharmacology, Lexi‑Drugs 'Off‑Label' with Evidence Level A
Contractors may request compendia or peer‑reviewed literature to support off‑label anti‑cancer use

Billing Rule

Home IVIG bundled payment operational rule (effective 2024‑01‑01)

Home IVIG (for listed primary immune deficiency ICD‑10 codes) administered in the home on/after 2024‑01‑01 is payable as a permanent daily bundled payment to a DME supplier. The bundle is a single per‑calendar‑day payment covering items and services furnished in the home during that day; the pump may or may not be used but a pump is not covered under the home IVIG bundle. The DME supplier bills the bundled payment and claims must include the required diagnosis demonstrating PID.

DME supplier bills the permanent daily bundled payment effective 2024‑01‑01
Bundle pays for all items/services furnished in the home during the calendar day; pump not included in bundle
Physician must document a primary immune deficiency diagnosis (listed ICD‑10 codes) and that home administration is appropriate

DME Necessary and Reasonable Determinations:

Necessity: expected meaningful contribution to treatment or improvement; physician prescription and medical info usually sufficient. Reasonableness: consider program expense vs therapeutic benefit, cost vs appropriate alternatives, and availability of similar equipment. Payment may be limited to rate for equipment/alternative if item substantially more costly.

Establishing Period of Medical Necessity for DME: Period generally based on physician's estimate; reasonable useful lifetime determined through program instructions; absent instructions A/B MACs may determine but not less than 5 years; computation based on delivery date, not equipment age; replacement due to wear not covered during useful lifetime (repairs covered up to cost of replacement).

Repairs, Maintenance, Replacement, Delivery (DME): Repairs to owned equipment covered when necessary to make serviceable; not covered for previously denied equipment or items in frequent/substantial servicing or oxygen categories; no payment for repairs exceeding cost of purchasing/renting another item for remaining medical need; no new CMN/order needed for repairs/maintenance; routine periodic maintenance not covered; replacement identical or nearly identical may be covered for loss or irreparable damage with physician order/CMN when required; replacement due to irreparable wear not covered during useful lifetime; cases suggesting malicious damage may be investigated and denied; delivery payment generally included in fee schedule; special rules for exceptional cases.

DME Supplies and Drugs for Equipment: Payment may be made for supplies necessary for effective use of DME (e.g., drugs/biologicals put directly into equipment). Coverage of such drugs does not preclude need to determine drug itself is reasonable/necessary. Prescription drugs (other than oxygen) used with DME must be dispensed directly to patient by entity with Medicare supplier number and state license; dispenser must bill and receive payment in its own name; suppliers cannot purchase drugs for resale to beneficiary. Reimbursement for replacement essential accessories only if beneficiary owns or purchasing equipment.

Incurred Expense Dates and Delivery/Shipping Date Rules: Date of service on DMEPOS claim must be date beneficiary or authorized representative received DMEPOS item; if not specified assume date of purchase equals delivery; for mail order items date of service is shipping date; if supplier delivered to nursing facility date of service is date received by facility or shipping date if shipped; exception: items provided up to two days prior to hospital discharge for fitting/training bill date of discharge to home and use POS=12.

Lump Sum Payment Equipment Delivery Exclusion: For items subject to lump sum payment, beneficiary must have been in US and have Medicare coverage at time item delivered; items delivered outside US or before coverage began excluded from coverage. If individual outside US >30 days and returns, DME MAC determines medical necessity as initial case before resuming payments.

DMEPOS Benefit Category Determination Inclusion Criteria: Whether an item falls under a Medicare benefit category (e.g., Part B DME) determines coverage and applicable payment rules; DMEPOS BCDs established on/after Sept 26, 2022 via rulemaking or procedures at 42 CFR 414.114/240/1670 and associated with new HCPCS Level II codes; benefit category and payment rules for items assigned to existing HCPCS codes determined by existing code's rules.

Billing Rule

DME date‑of‑service billing rules (shipping/receipt dates; POS=12 exception)

DME date‑of‑service rules: use the shipping date as date of service for mail‑order DMEPOS; if supplier delivers to a nursing facility, use the facility receipt date (or shipping date if shipped); exception: items delivered up to two days before hospital discharge for fitting/training should be billed with date of discharge to home and POS=12.

Mail order DMEPOS: date of service = shipping date
Deliveries to nursing facility: date of service = date received by facility (or shipping date if shipped)
Items delivered ≤2 days before hospital discharge for fitting/training: bill date of discharge to home and use POS=12

Documentation Required

Retain CMNs/orders and document delivery/receipt for replacements & repairs

Suppliers must retain Certificates of Medical Necessity (CMNs) or physician orders for replacements and repairs and keep documentation that supports medical necessity. For replacement/repair claims, suppliers should document delivery/receipt dates and maintain records of the item's status (loss, irreparable damage, or end of useful lifetime) to support billing.

Retain CMNs/orders when billing replacements or repairs of DME
Document delivery and receipt dates supporting date‑of‑service on claims
Maintain records showing loss, irreparable damage, or useful lifetime status for replacement claims

Certification and Recertification: Physician/NPP certification required for coverage/payment; initial certification must be obtained as soon as possible or within 30 days of initial therapy treatment; if verbal signature must follow within 14 days; certification covers up to 90 calendar days or duration of plan, whichever less; recertification required when need for significant modification occurs or at least every 90 days after initiation of treatment under that plan; delayed certification rules apply (acceptable without justification for 30 days after due; include reason and supporting evidence for longer delays); payments should not be denied solely due to delayed certification if evidence exists physician/NPP was involved.

Delayed Certification: Delayed certifications acceptable when provider documents reason; for long delayed (>6 months) contractor may require additional documentation; certification acceptable without justification for 30 days after due; payment not to be denied solely due to delay if evidence physician/NPP involved; deny when certification signed long after treatment by physician/NPP with no evidence of involvement.

Plan Changes: Changes must be documented and signed by physician/NPP, PT, OT, SLP, or RPN/physician/NPP per oral orders; therapist may not significantly alter physician/NPP-established plan without documented approval; significant changes (e.g., long-term goals change) require physician/NPP certification within 30 days of initial therapy under revised plan; insignificant alterations (frequency/duration adjustments, short-term goal changes) do not require physician signature.

Documentation and Claims Requirements: Claims must include NPI of certifying physician for outpatient/CORF PT/OT/SLP DOS on/after 2012-10-01; providers should retain certification and plan of care in clinical record and make available to contractor; functional reporting historically required but discontinued for DOS on/after 2019-01-01.

Reasonable and Necessary - General Conditions: Services must be skilled therapy services rendered under described conditions; services that can be self-administered or safely furnished by unskilled persons without supervision are not skilled and not covered; services may be necessary to improve, maintain, or prevent/slow deterioration; amount/frequency/duration must be reasonable under accepted standards; if services require skills of qualified therapist contractor shall presume proper supervision (rebuttable).

Maintenance Program Coverage Conditions: Maintenance program coverage scenarios: establishment/design/instruction and periodic reevaluation by qualified therapist covered when specialized skill/knowledge/judgment required; delivery covered when individualized assessment shows specialized judgment/skills of therapist necessary to perform safe and effective services (either complexity/sophistication or special medical complications requiring therapist skills).

Rehabilitative Therapy Coverage: Rehabilitative therapy covered when designed to address recovery/improvement in function with evaluations/re-evaluations and progress reports showing objective measurements indicating improvement or rationale for continued treatment; requires therapist skills to safely/effectively furnish recognized therapy service whose goal is improvement; if expected potential insignificant relative to therapy required, not reasonable/necessary.

Evaluation and Re-evaluation: Evaluation is separately payable comprehensive service by clinician to develop plan of care; re-evaluation payable when significant improvement/decline/change not anticipated in plan; re-eval indicated for new clinical findings, significant change in condition, or failure to respond; re-eval requires same professional skills as initial eval; SLP uses evaluation CPT for re-eval as no separate SLP re-eval code defined.

Progress Report Timing and Content: Minimum progress report at least once every 10 treatment days beginning first day of episode; end of period is clinician chosen date or 10th treatment day whichever shorter; if missed must be written within 7 calendar days after end of reporting period; progress report must document clinician's active participation in treatment during period; clinician-written reports need not be signed by physician/NPP except when required for incident-to billing; content: assessment of improvement toward each goal, plans for continuing treatment, changes to goals/discharge/update plan, functional documentation when applicable.

Treatment Note Requirements: Each treatment note must include date of treatment; identification of each specific intervention/modality provided and billed in language comparable to billing; total timed code treatment minutes and total treatment time in minutes (includes timed and untimed codes; excludes non-billable time); signature and professional identification of qualified professional who furnished or supervised services and list of persons who contributed; when treatment added/changed between progress reports change must be recorded and justified.

Functional Reporting (historical 2013-2018): Applicable 2013-2018 only: one functional G-code reported reflecting primary functional limitation; clinician selects G-code and one severity modifier (CH-CN) reflecting percent impairment ranges; clinician documents how modifier selection made; documentation must be included in medical record. Note: functional reporting discontinued for DOS on/after 2019-01-01.

Group Therapy (97150): Contractors pay for outpatient PT/SLP and OT services provided simultaneously to two or more individuals as group therapy (97150); practitioner must be in constant attendance; only services of therapist billed and paid under Part B; services by a student not reimbursed even if supervised.

Qualified professional definitions and supervision: Qualified professional: PT, OT, SLP, physician, NP, CNS, PA licensed/certified by state; qualified personnel: auxiliary staff educated/trained to furnish therapy under direct supervision incident to physician or NPP; PTAs/OTAs have specific supervision/on-site visit requirements (at least once every 30 days in clinics/rehab agencies) and may not provide evaluative services or bill incident-to; students' services not reimbursed.

Incident-to Therapy Services: Therapy services billed incident-to physician/NPP must meet incident-to requirements including direct supervision by physician/NPP present in office suite and immediately available; services must represent an expense to billing entity and relate directly to physician/NPP service; PTAs/OTAs shall not be billed incident-to physician/NPP service.

Documentation Required

Plan of care, physician/NPP certification timing, progress report & treatment note elements

Before treatment each patient must have a plan of care. The certifying physician/NPP must sign certification within 30 days of initial therapy (signature/received date acceptable); progress reports are required at least once every 10 treatment days. Treatment notes must include date, interventions, timed minutes and total treatment time, and clinician signature. For claims with dates of service on/after 2012‑10‑01 include the certifying physician NPI on the claim. The certifying physician/NPP must be identified on the plan and certification; recertify at least every 90 days or when significant plan changes occur.

Plan of care established before treatment begins
Physician/NPP certification: as soon as possible and within 30 days of initial therapy; signature or received date valid
Progress reports: minimum once every 10 treatment days
Each treatment note: date, specific interventions, total timed minutes and total treatment time, and clinician signature
Include certifying physician NPI on claims for DOS on/after 2012‑10‑01

Billing Rule

Incident‑to therapy billing: PTA/OTA services not billable incident‑to physician/NPP

Therapy billed 'incident to' a physician/NPP must meet therapy standards and the incident‑to rules (including direct supervision in private practice). Services furnished by PTAs/OTAs must not be billed as incident‑to a physician/NPP; PTA/OTA services shall not be billed as incident‑to physician/NPP because they do not meet therapist qualifications for incident‑to billing.

Incident‑to therapy must meet therapy benefit standards and incident‑to criteria (direct supervision etc.)
PTA/OTA services shall not be billed as incident‑to a physician/NPP (they are therapy benefit services)

Intensive Cardiac Rehabilitation (ICR) - Coverage and Standards: ICR is an approved program that furnishes CR plus has peer-reviewed published research demonstrating benefit (e.g., reduced need for CABG/PTCA, specific biomarker reductions) and meeting outcome measures; ICR session limits: 72 1-hour sessions total, up to 6 sessions/day over up to 18 weeks; prospective ICR sites must apply and report specialty code 31; medical director and supervising practitioner must have expertise in cardiac pathophysiology and BLS/ACLS training; settings physician office or hospital outpatient with physician/NPP immediately available.

Diabetes Self-Management Training (DSMT) and Kidney Disease Education (KDE)

Diabetes Self-Management Training (DSMT) and Kidney Disease Education (KDE): eligibility, accredited provider requirements, session limits — DSMT initial 10 hrs (one hour may be individual), follow-up up to 2 hrs/year; KDE up to 6 sessions lifetime (>=31 minutes counts as 1), billing codes G0108/G0109 and G0420/G0421.

Diabetes Self-Management Training (DSMT) - Eligibility and Provider Requirements: DSMT covered when treating physician certifies services needed and maintains plan of care; order must include number of initial/follow-up hours, topics, and individual vs group; provider must be accredited by CMS-approved national accreditation organization; certified providers bill DSMT and must be entities that bill Medicare for other services; registered dietitians may bill on behalf of program if they have Medicare provider number but may not be sole provider except rural-area exception.

DSMT - Initial and Follow-Up Session Limits: Initial training: up to 10 hours within continuous 12-month period (0.5 hour increments), usually in group setting except up to 1 hour individual; follow-up: up to 2 hours individual or group per year; group = 2-20 individuals; initial = G0108/G0109 codes; billing revenue code 942 on UB-04; certification by physician/NPP required.

DSMT - Individual Training Coverage Conditions: Individual DSMT covered if: no group session available within 2 months of order; physician documents beneficiary has special needs (severe vision/hearing/language limitations) that hinder group participation; or physician orders additional insulin training.

Kidney Disease Education (KDE) - Eligibility and Coverage: KDE covered for beneficiaries diagnosed with Stage IV CKD (GFR 15-29 mL/min/1.73m2) with physician referral documented in medical records; furnished by qualified persons (physician, PA, NP, CNS or certain rural facilities/hospitals/CAHs/SNFs/CORFs/HHAs/hospices in rural areas); incident-to requirements do not apply; KDE billing codes G0420 (individual) and G0421 (group); up to six 1-hour sessions lifetime (>=31 minutes counts as 1 session); group=2-20; diagnosis code N18.4 or legacy 585.4.

Sleep disorder clinic testing coverage and frequency guidance

Sleep disorder clinic diagnostic test coverage and ordinary testing frequency guidance — narcolepsy naps (3), polysomnography limits for sleep apnea (1), nocturnal penile tumescence (2 nights) and polysomnography for chronic insomnia not covered.

Sleep Disorder Clinic Diagnostic Test Coverage Criteria: Diagnostic tests covered when clinic affiliated with hospital or under physician direction; patients referred by attending physicians with record of orders; need confirmed by medical evidence; testing covered only for specified conditions (narcolepsy, sleep apnea, impotence nocturnal penile tumescence, parasomnia).

Ordinary Testing Frequency Guidance: Narcolepsy ordinarily confirmed by three sleep naps; >3 naps requires persuasive medical evidence (HCPCS: 95828, 95805). Sleep apnea ordinarily a single polysomnogram/EEG; >1 requires persuasive medical evidence (HCPCS: 95807, 95810, 95822). Nocturnal penile tumescence ordinarily two nights; >2 nights requires persuasive medical evidence (HCPCS: 54250). Parasomnia use HCPCS 95807/95810/95822 and EEGs when seizures suspected. Polysomnography for chronic insomnia not covered.

Diagnostic Test Supervision Levels: Diagnostic tests payable under MPFS require appropriate physician supervision per assigned numeric level (general/direct/personal) as in MPFS database; effective 2021-01-01 tests must be furnished under appropriate supervision by physician or where authorized by state law by NP/CNS/CNM/CRNA/PA; services without required level not reasonable/necessary.

Chiropractic coverage: manual spinal manipulation for subluxation and documentation

Chiropractic coverage criteria: manual spinal manipulation only for subluxation; documentation requirements for initial/subsequent visits; AT modifier required for active/corrective treatment and absence implies maintenance therapy (not covered); contraindications and one-treatment-per-day frequency limit.

Chiropractic services - coverage limited to manual spinal manipulation for subluxation: Coverage limited to manual manipulation of spine to correct a subluxation; x-rays may be used for documentation but x-ray/other diagnostic services by chiropractor are not separately covered; manual handheld devices may be used but no separate payment; an x-ray not required effective Jan 1, 2000 to demonstrate subluxation.

Documentation requirements - Initial and Subsequent Visits: Initial visit documentation: detailed history, description of present illness linked to subluxation level, physical exam (two of four criteria required including asymmetry/misalignment or ROM abnormality), primary diagnosis must be subluxation with level, treatment plan including duration/frequency and goals, date of initial treatment. Subsequent visits: review chief complaint, exam of involved spinal area, assessment of change since last visit, documentation of treatment given.

Maintenance therapy exclusion and AT modifier: Maintenance therapy not paid; defined as treatment seeking to prevent disease, promote health, prolong quality of life or maintain/prevent deterioration when further clinical improvement cannot reasonably be expected; chiropractors must place AT modifier when providing active/corrective treatment; absence of AT on claim implies maintenance therapy and claims without AT will be denied; if ABN given include GA (or rarely GZ) modifier per instructions.

Contraindications to dynamic thrust: Relative contraindications include articular hypermobility, severe demineralization, benign bone tumors of spine, bleeding disorders/anticoagulant therapy, radiculopathy with progressive neurological signs. Absolute contraindications include acute inflammatory arthropathies with ligamentous laxity, acute fractures/dislocations, unstable os odontoideum, malignancies of vertebral column, infection of vertebral bones/joints, signs of myelopathy/cauda equina, vertebrobasilar insufficiency for cervical manipulations, major artery aneurysm near manipulation site.

One-treatment-per-day frequency limit: Medicare reimbursement limited to not more than one chiropractic treatment per day; room/ward fees not covered; intensive multiple daily visits not supported for reimbursement beyond one per day.

Billing Rule

Group therapy billing (97150) and specialty exceptions

Bill group therapy under CPT 97150 when a practitioner provides therapy simultaneously to two or more individuals and remains in constant attendance. Group therapy rules apply per MPFS; services by students are not separately reimbursable. For dental/prosthetic exceptions, follow specialty sections (e.g., dental services paid when inextricably linked to covered medical procedures).

97150 for group therapy when therapist in constant attendance and treating ≥2 patients
Students' services are not reimbursed even if present in room
Follow specialty sections for dental/prosthetic exceptions when applicable (e.g., dental services linked to covered medical care)

Documentation Required

Sleep testing: keep persuasive medical evidence when tests exceed ordinary frequency

When sleep testing frequency exceeds ordinary expected counts (e.g., narcolepsy >3 sleep naps; sleep apnea >1 polysomnogram; nocturnal penile tumescence >2 nights), maintain persuasive medical evidence justifying additional tests. Document medical necessity for each additional study and retain supporting records for contractor review.

Narcolepsy: ordinarily 3 sleep naps — >3 requires persuasive medical evidence (HCPCS 95828, 95805)
Sleep apnea: ordinarily single polysomnogram — >1 polysomnogram requires persuasive medical evidence (HCPCS 95807, 95810, 95822)
Nocturnal penile tumescence: ordinarily 2 nights — >2 requires persuasive medical evidence (HCPCS 54250)

CPO: document ≥30 min/month; prior E/M within 6 months (CPO rules) — Plan/Codes: 99238‑99239 exclusions (see CPO section)

Consultation coding: stop using 99241‑99245 & 99251‑99255 for Medicare outpatient; use appropriate E/M codes

Teaching physician: be present for key portion or repeat & document; signed/countersigned notes required

Opt‑out affidavit & private contract: file affidavit with MACs (include NPI/TIN), retain private contracts for 2‑year period; 45‑day contractor cure period; 90‑day early termination rules

Emergency/urgent opt‑out billing: use GJ modifier (and 54 when applicable); limit charges to limiting charge or collect deductible/coinsurance accordingly

Opt‑out denials: CARC 27 + PR + MA47 (or MA47 N771) and MSN messages required

Off‑label anti‑cancer: support with NCCN/DrugDex/AHFS/Clinical Pharmacology/Lexi or peer‑reviewed clinical literature

Home IVIG: DME supplier bills daily bundle for infusions on/after 2024‑01‑01; pump not included; use PID ICD‑10 codes

Home infusion: supplier accreditation required; physician plan of care with signature before claim; G‑code per infusion drug administration calendar day; include time in 15‑minute increments

Action checklist (immediate / watchlist / denial risks)

Immediate actions - CPO documentationEnsure CPO note documents physician identity, date, and >=30 minutes of physician CPO time in the calendar month; confirm prerequisite face-to-face E/M within prior 6 months

Immediate actions - Certifying physician NPIInclude certifying physician NPI on outpatient PT/OT/SLP claims (effective for DOS on/after 2012-10-01)

Immediate actions - Opt-out emergency claimsFor emergency/urgent care by an opt-out physician without private contract, submit claim with GJ modifier (and 54 where appropriate) so contractor can process; physician limited to Medicare limiting charge or assignment rules

Immediate actions - AWV SDOH billingWhen SDOH Risk Assessment (G0136) furnished as AWV element, report G0136 with modifier -33 on same claim/date as G0438/G0439 to be separately payable without cost sharing

Watchlist - Self-administered drug determinationsA/B MACs determine 'usually self-administered' (>50% threshold) per drug/indication; watch for denials if injectable deemed usually self-administered

Watchlist - Home IVIG bundlingHome IVIG administration bundled payment effective 2024-01-01 paid to DME supplier for all items/services furnished in home during calendar day; pump not paid separately under bundle

Denial risks - Missing CPO certification/detailsDenial risk if CPO lacks documentation of date, time length, physician who signed plan of care, or prerequisite E/M within 6 months

Denial risks - Improper supervision for 'incident-to' or diagnostic testsEnsure required direct/personal/general supervision levels are met per setting; noncompliance can trigger denials

Denial risks - Opt-out violationsSubmitting claims while opted-out (or failing to maintain opt-out rules) exposes physician to claim denials, CARC 27/PR and remark codes MA47/MA47 N771 and beneficiary liability (MSN messages)

name	number	effective_date
Home infusion therapy services payment (Transmittal R10547BP)	R10547BP	Impl: 01-04-2021; Effective: 01-01-2021
Permanent bundled home IVIG payment (Consolidated Appropriations Act, 2023)	(Referenced in Chapter 15 updates)	Effective: 01-01-2024
PR/CR/ICR program coverage expansion (Transmittal R12497BP)	R12497BP	Impl: 03-12-2024; Effective: 01-01-2024
MFT and MHC services manual update (Transmittal R12448BP)	R12448BP	Impl: 02-12-2024; Effective: 01-01-2024
Home IVIG coverage provision (Transmittal R12352BP)	R12352BP	Impl: 01-02-2024; Effective: 01-01-2024

Glossary of selected high‑value definitions in this extract (concise, Medicare wording preserved):

- SMI (Supplementary Medical Insurance): Medicare Part B coverage for medical and other health services enumerated in Chapter 15 (physician services, outpatient hospital, DME, therapy, diagnostic tests, preventive services, etc.) [[11]].

- CPO (Care Plan Oversight): physician supervision of complex home health or hospice patients involving plan development/revision, review of reports and studies, coordination with non‑employed professionals; payment requires ALL requirements including that the physician furnished at least 30 minutes of oversight in the calendar month, was the same physician who signed the plan of care, had a qualifying face‑to‑face E/M within 6 months, and documented dates and times [[28],[29],[30]].

- Private contract: a written agreement between a Medicare beneficiary and a physician/practitioner who has opted out for a 2‑year period, in which the beneficiary agrees to pay in full and accept that Medicare will not pay; contract must meet §40.8 content, be provided prior to services, retained by physician and made available to CMS [[59],[60],[61]].

- Opt‑out affidavit: written, signed filing with MACs by a physician/practitioner electing to opt out; must include identification (name/address/phone/NPI or TIN), attestations re: private contracting and non‑submission of claims (except emergency/urgent), and be filed with all MACs with jurisdiction; affidavits filed on/after 2015‑06‑16 auto‑renew every 2 years unless cancelled per rules [[63],[64]].

- DME (Durable Medical Equipment): equipment that can withstand repeated use, is primarily medical, not useful absent illness/injury, and appropriate for home use; DME coverage requires medical necessity and home use — repairs, maintenance, replacement, delivery, and date‑of‑service rules are specified [[110],[276],[298]].

- Compendium: an authoritative, publicly transparent drug/biological reference (e.g., USP‑NF, USD‑DI, AHFS‑DI, NCCN, DrugDex, Clinical Pharmacology, Lexi‑Drugs) used to determine medically‑accepted off‑label anticancer uses per defined acceptance criteria [[108],[148],[152]].

- Infusion drug administration calendar day: the calendar day on which professional home infusion therapy services were furnished in the patient's home to administer a qualifying home infusion drug; payment for a unit of single payment is made per such day (bundled for professional services, training/education, remote/monitoring) [[320],[718]].

- Home infusion drug (qualifying): parenteral drugs/biologicals administered IV or SC for an administration period of 15 minutes or more through a DME pump covered under Part B; excludes insulin pump systems and drugs on self‑administered exclusion lists; DME LCD L33794 guides qualifying drugs [[713],[714],[711]].

- Compendia evidentiary acceptance (off‑label anticancer): NCCN Category 1/2A or DrugDex Class I/IIa/IIb or supportive AHFS/Clinical Pharmacology narrative or Lexi 'Off‑Label' with Evidence Level A qualifies; conversely Category 3/DrugDex Class III/unsupported narratives are not accepted [[148]].

- Administrative thresholds cited: CPO monthly minimum time = 30 minutes; CPO prerequisite face‑to‑face E/M within 6 months; opt‑out cure period = 45 days; opt‑out initial period = 2 years; usually self‑administered drug threshold = >50% of Medicare beneficiaries; home infusion minimum administration = 15 minutes [[29],[71],[112],[715],[716]].

Legacy code change: G0107 (FOBT) discontinued and replaced with CPT code 82270 effective January 1, 2007; screening FOBT coverage defined under 82270/G0328.

2001-07-01revised

G0121 (screening colonoscopy for average-risk individuals) became covered effective July 1, 2001 with a 10-year frequency rule; prior to this date G0121 was used to bill/deny for non-high-risk colonoscopy (Jan 1, 1998–Jun 30, 2001).

1998-01-01revised

Initial Medicare colorectal screening HCPCS coverage established (G0104, G0105, G0106, G0107) and related frequency/age rules (screening FOBT annual for beneficiaries age 50+).

2023-01-01clarifiedLatest

Follow-on screening colonoscopy after a positive non-invasive stool-based test (gFOBT 82270, iFOBT G0328, or stool DNA 81528) is covered and not subject to the standard frequency limits for screening colonoscopy.