CurrentCapital BluecrossPolicy N/A

Chapter 15 - Covered Medical and Other Health Services (Medicare Part B benefit policy)

This document is a table of contents and selected sections from Chapter 15 of Medicare Benefit Policy describing covered medical and other health services under Part B, including transmittals, definitions, coverage categories (physician services, diagnostic tests, DME, drugs/biologicals, rehabilitation, home infusion, etc.), rules for when expenses are incurred, and detailed provisions for physician services (consultations, concurrent care, care plan oversight, teaching physician rules, interns/residents, optometrists, chiropractors).

Policy Summary

PayerCapital Bluecross

PolicyChapter 15 - Covered Medical and Other Health Services (Medicare Part B benefit policy)

Policy CodePolicy N/A

Change TypeTransmittal updates (revised and informational)

Effective Date

Next Review Date

Key ActionPhysician billing CPO must document services furnished and the date and length of time associated with those services in the patient's record.

SourceLink

POLICY UPDATE CHANGES

Billing for Home Infusion Therapy Services On or After January 1, 2021 (Transmittal R10547BP).

Updates to Pub. 100-02 for Marriage and Family Therapists and Mental Health Counselors (Transmittal R12448BP).

Lists transmittals R01BP through R72BP with issue dates, subjects, implementation dates, and CR numbers.

1Chapter included (TOC pages present)

2024-01-01IVIG home bundled payment effective

2 years

Opt-out period length

45 daysOpt-out response time

GJRequired modifier for emergency/urgent opt-out claims

Coverage Summary & Scope

This chapter (Chapter 15 Part B) provides Medicare Part B coverage policy for a wide range of services and supplies. It addresses physician professional services (including consultations, concurrent care, teaching physician rules, care plan oversight), drugs and biologicals (including compendia, self‑administration determinations, incident‑to rules, and immunizations), durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) and related supplier/enrollment issues, outpatient rehabilitation/therapy (PT, OT, SLP) including documentation and plan‑of‑care requirements, home infusion and IVIG in‑home infusion (benefit definition, supplier and plan‑of‑care requirements, payment categories), preventive/screening services (mammography, colorectal screening, Pap, glaucoma, AWV and related elements), chiropractic/maintenance care, ambulatory surgical center (ASC) facility scope and payment distinctions, and behavioral health provider types and qualifications (clinical psychologists, CSWs, CNMs, PAs, NPs, CNSs, SLPs, MFTs, MHCs). It also details beneficiary/provider obligations for private contracts/opt‑out and related billing/modifier rules. (High‑level overview only.)

Key thresholds / facts

Care Plan Oversight monthly time threshold>= 30 minutes per calendar month

CPO face-to-face prerequisiteFace-to-face E/M within 6 months before first CPO service

Opt-out response time (to MAC development letter)45 days to respond/explain or correct

Participating physician opt-out notice periodAt least 30 days before first day of next calendar quarter

Initial opt-out period length2 years

Functional reporting removal dateFunctional G-code reporting not applicable for DOS on/after 2019-01-01

IVIG home bundled payment effective date2024-01-01

Coverage / Medical Necessity Criteria (by topic)

Care Plan Oversight (CPO) Services - Coverage Requirements

Care Plan Oversight (CPO) services are covered when ALL of the following are met:

ALL of the following

The billing practitioner is a physician or other practitioner legally authorized to provide and supervise care plan oversight services in the practitioner’s state of enrollment.
There is an established plan of care for the beneficiary that is being monitored and revised as appropriate by the practitioner.
The services consist of interdisciplinary assessment, development, revision, or monitoring of the beneficiary’s care plan related to active, complex, or high-risk conditions; coordination of therapies and services; and communication with other treating practitioners and caregivers as needed.
Documentation in the medical record demonstrates the medical necessity of oversight (specific problems addressed, changes made to plan of care, communication with other providers, and time spent).

Codes & Coding Groups

Referenced CPT/HCPCS codes in textmixed

99238	Hospital discharge day management
99239	Hospital discharge day management
99217	Discharge from observation
99241-99245	CPT consultation codes (no longer recognized for Medicare payment as of 2010)
99251-99255	Consultation CPT codes (no longer recognized for Medicare payment as of 2010)
G-codes	Inpatient telehealth consultation HCPCS G-codes (referenced generically)

Referenced regulatory citations and manualsmixed

42 CFR 413.65	Provider-based definition reference
Section 1880 of the Social Security Act	IHS payment exception authority
Section 1802(b) of the Act	Private contract/opt-out statutory authority
Pub. 100-04, Medicare Claims Processing Manual, chapter 19	Claims processing reference
42 C.F.R §405.420	Opt-out affidavit filing requirement

Required Emergency/Urgent Care ModifierHCPCSCovered

GJ	Opt-out physician/practitioner EMERGENCY OR URGENT SERVICES modifier

Examples of Additional Modifiers MentionedModifier|HCPCS

54	Surgical care only modifier (example used with GJ for fractured leg)

Claim Adjustment/Remittance Codes for Denialsmixed

27	Claim Adjustment Reason Code: expenses incurred after coverage terminated
PR	Group code: Patient responsibility
MA47	Remittance advice remark code indicating provider opted out; patient responsible
MA47 N771	Remittance advice remark code variant for knowing/willful submission with limiting charge alert

MSN Messagesmixed

MSN #21.20	Provider dropped out of Medicare; no payment; patient responsible
MSN #21.19	Provider dropped out; no payment; patient responsible; doctor cannot charge more than limiting charge

No specific billing codes in this excerptmixed

No codes listed

ICD-10-CM codes referenced for IVIG primary immune deficiency coverage (partial list provided in excerpt)ICD-10Covered

G11.3
D80.0
D80.2
D80.3
D80.4
D80.5
D80.6
D80.7
D81.0
D81.1

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1/3

Sleep disorder clinic diagnostic HCPCS/CPT codes referencedHCPCS|CPTCovered

95828	Multiple sleep latency test (MSLT) - sleep naps (narcolepsy)
95805	Sleep study nap/EEG related (used with 95828 per text)
95807	Polysomnography; with CPAP titration, attended
95810	Polysomnography including EEG
95822	Polysomnography; with multiple sleep latency test components
54250	Nocturnal penile tumescence testing

DMEPOS Benefit Category Determinations (examples listed)HCPCS

A4271	Integrated lancing and blood sample testing cartridges for home blood glucose monitor, per month. Benefit Category Determination = DME.
A4287	Disposable collection and storage bag for breast milk, any size, any type, each. Benefit Category Determination = Contractor discretion when used with manual breast pumps (No Medicare DMEPOS benefit when used with electric breast pumps noted variably).
A4295	Intermittent urinary catheter; straight tip, hydrophilic coating, each. Benefit Category Determination = Prosthetic Device.
A4296	Intermittent urinary catheter; coude (curved) tip, hydrophilic coating, each. Benefit Category Determination = Prosthetic Device.
A4297	Intermittent urinary catheter; hydrophilic coating, with insertion supplies. Benefit Category Determination = Prosthetic Device.
A4438	Adhesive clip applied to the skin to secure external electrical. Benefit Category Determination = Prosthetic Device.
A4341	Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each. Benefit Category Determination = Prosthetic Device.

HCPCS codes with Benefit Category Determinations (DME)HCPCSCovered

A4271	Integrated lancing and blood sample testing cartridges for home blood glucose monitor, per month. Benefit Category Determination = DME. HCPCS Coding Cycle = Second Biannual, 2023.
A4541	Monthly supplies for use of device coded at E0733. Benefit Category Determination = DME. HCPCS Coding Cycle = First Biannual, 2022.
E0468	Home ventilator, dual-function respiratory device, also performs cough stimulation, includes all accessories. Benefit Category Determination = DME. HCPCS Coding Cycle = Second Biannual, 2023.
E0469	Lung expansion airway clearance, continuous high frequency oscillation, and nebulization device. Benefit Category Determination = DME. HCPCS Coding Cycle = First Biannual, 2024.
E0530	Electronic positional obstructive sleep apnea treatment, with sensor, includes all components. Benefit Category Determination = DME. HCPCS Coding Cycle = First Biannual, 2022.
E0736	Transcutaneous tibial nerve stimulator. Benefit Category Determination = DME. HCPCS Coding Cycle = Second Biannual, 2023.
E0738	Upper extremity rehabilitation system providing active assistance, includes microprocessor. Benefit Category Determination = DME. HCPCS Coding Cycle = Second Biannual, 2023.

HCPCS codes with No Medicare DMEPOS benefit category / Not Covered by MedicareHCPCSNot Covered

A4287	Disposable collection and storage bag for breast milk, any size/type, each. Benefit Category Determination = Contractor discretion when used with manual breast pumps (No Medicare DMEPOS benefit). HCPCS Coding Cycle = First Biannual, 2022.
A4457	Enema tube, with or without adapter, any type, replacement only, each. Benefit Category Determination = No Medicare DMEPOS benefit category. HCPCS Coding Cycle = First Biannual, 2022.
A4560	Neuromuscular electrical stimulator (NMES), disposable, replacement only. Benefit Category Determination = No Medicare DMEPOS benefit category. HCPCS Coding Cycle = Second Biannual, 2022.
A7023	Mechanical allergen particle barrier/inhalation filter, cream, nasal, topical. Benefit Category Determination = No Medicare DMEPOS benefit category. HCPCS Coding Cycle = First Biannual, 2022.
E0492	Power source and control electronics unit for oral device, controlled by phone application. Benefit Category Determination = No Medicare DMEPOS benefit category. HCPCS Coding Cycle = First Biannual, 2022.
E0493	Oral device/appliance for neuromuscular electrical stimulation of tongue muscle, controlled by phone application, 90-day supply. Benefit Category Determination = No Medicare DMEPOS benefit category. HCPCS Coding Cycle = First Biannual, 2022.
K1034	Provision of COVID-19 test, nonprescription self-administered and self-collected use. Benefit Category Determination = No Medicare DMEPOS benefit category. HCPCS Coding Cycle = Second Biannual, 2022.

Processing/Payment Entitiesmixed

A/B MAC

Durable Medical Equipment Medicare Administrative Contractors — responsible for claims processing and determinations (DME MACs referenced for diabetic shoes and lymphedema bandaging discretion).

Functional reporting / G-code requirement (historical)CPT

G-codes

Functional reporting G-codes and related modifiers historically required for outpatient therapy claims (requirement removed for dates of service on/after 2019-01-01).

Regulatory references and Medicare rules citedmixed

42CFR424.24	Plan of care requirements / certification
42CFR410.61	Outpatient therapy coverage rules
42CFR410.105	Coverage for Comprehensive Outpatient Rehabilitation Facilities (CORFs)
42CFR410.59	Reasonable and necessary services - general
42CFR410.60	Requirement services be furnished on an outpatient basis
SSA 1835(a)(2)	Periodic review statutory requirement for certification
Section 1879	Waiver of liability provisions (ABN)
Section 1833(g)(8)	Limitation of liability protections re: therapy services and -KX modifier

Functional reporting codes mentionmixed

G-codes

Nonpayable functional reporting G-codes and severity modifiers referenced for documentation (functional reporting not applicable for DOS on/after 2019-01-01)

Functional reporting non-payable HCPCS G-codes and severity modifiers (applicable to 2013-2018)HCPCS

G-codes (42 total, 14 sets of 3)	Functional limitation reporting codes (6 PT/OT sets, 8 SLP sets)
CH	Severity modifier: 0% impaired
CI	Severity modifier: >=1% and <20% impaired
CJ	Severity modifier: >=20% and <40% impaired
CK	Severity modifier: >=40% and <60% impaired
CL	Severity modifier: >=60% and <80% impaired
CM	Severity modifier: >=80% and <100% impaired
CN	Severity modifier: 100% impaired

Therapy billing codes referenced (examples)CPT/HCPCS

92526	Example SLP code billed three times weekly in example progress report
97150	Group therapy services

Billing / Claims processing referencemixed

13X / 85X

Hospital bill types for outpatient therapy (13X hospital outpatient; 85X critical access hospitals)

Regulatory citations referencedmixed

42 CFR 410.49	Medicare coverage criteria for cardiac rehabilitation and ICR
42 CFR 410.26	Direct supervision requirements for physician office services
42 CFR 410.27	Direct supervision requirements for hospital outpatient services
42 CFR 424.510	Enrollment/application for ICR program sites
42 CFR 416.25-416.49	ASC conditions of coverage
Section 1848(b)(5) of the Act	Definition of 1-hour session for ICR
Section 1861(aa)(5)(A) of the Act	Definition of nonphysician practitioner

Chiropractic Reporting / Modifiers (operational)ModifierCovered

AT	Active/corrective treatment modifier — must be placed on claims for active/corrective treatment; absence may result in denial as maintenance therapy
GA	Advance Beneficiary Notice (ABN) modifier when ABN given and billing accordingly
GZ	Reasonable and necessary modifier in rare instances with ABN (rarely used)

ICR Supplier Specialty Codemixed

31	Specialty code to be reported to identify an enrolled ICR supplier site

Glaucoma Screening HCPCSHCPCSCovered

G0117	Glaucoma screening for high-risk patients furnished by an optometrist or ophthalmologist
G0118	Glaucoma screening for high-risk patients furnished under the direct supervision of an optometrist or ophthalmologist

Colorectal Cancer Screening HCPCS/G and CPTHCPCS|CPTCovered

G0107	Colorectal cancer screening; fecal-occult blood test, 1-3 simultaneous determinations (historical replaced by 82270)
G0328	Colorectal cancer screening; fecal-occult blood test, immunoassay, 1-3 simultaneous determinations
82270	Fecal occult blood test (gFOBT) - CPT
G0104	Colorectal cancer screening; flexible sigmoidoscopy
G0105	Colorectal cancer screening; colonoscopy on individual at high risk
G0106	Colorectal cancer screening barium enema; alternative to G0104
G0120	Colorectal cancer screening barium enema; alternative to G0105
G0121	Colorectal cancer screening; colonoscopy on individual not meeting criteria for high risk (covered since 2001)
81528	Cologuard™ - multi-target stool DNA (sDNA) test (non-invasive stool-based test referenced)

Mammography Screening - billing guidanceHCPCS|RevenueCovered

unspecified

Screening mammography codes per Medicare Claims Processing Manual Chapter 18; revenue and billing rules referenced

Screening Pap Smear - diagnostic codes for screening indicatorICD-10

Z112.4	Encounter for screening for malignant neoplasm of cervix (screening indicator)
V76.2	ICD-9 screening code historical (screening indicator)

KDE HCPCS CodesHCPCSCovered

G0420	KDE: Face-to-face educational services; individual, per session, per one hour
G0421	KDE: Face-to-face educational services; group, per session, per one hour

KDE Diagnosis CodesICD-10|ICD-9-CMCovered

585.4	Chronic kidney disease, Stage IV (ICD-9-CM)
N18.4	Chronic kidney disease, Stage IV (ICD-10-CM)

AWV and Related HCPCSHCPCSCovered

G0438	Initial Annual Wellness Visit (AWV) with PPPS
G0439	Subsequent Annual Wellness Visit (AWV) with PPPS
G0136	Social Determinants of Health (SDOH) Risk Assessment (report with -33 when furnished as AWV element)

SDOH billing modifier requirementModifier

33	Modifier -33 required when billing G0136 as an additional element of AWV to avoid cost-sharing

DSMT HCPCSHCPCSCovered

G0108	Diabetes outpatient self-management training services, individual, per 30 minutes
G0109	Diabetes outpatient self-management training services, group session (2 or more), per 30 minutes

DSMT Revenue CodeRevenue

942	Revenue code for DSMT services (FL 42)

KDE HCPCS CodesHCPCSCovered

G0420	Individual, per session, per one hour
G0421	Group, per session, per one hour

HCPCS codes with Benefit Category Determinations (DME)HCPCSCovered

E0733	Transcutaneous electrical nerve stimulator for trigeminal nerve. Benefit Category Determination = DME. HCPCS Coding Cycle = First Biannual, 2022.
E0734	External upper limb tremor stimulator of peripheral nerves of wrist. Benefit Category Determination = DME. HCPCS Coding Cycle = First Biannual, 2022.
E0743	External lower extremity nerve stimulator for restless legs syndrome, each. Benefit Category Determination = DME. HCPCS Coding Cycle = First Biannual, 2024.

HCPCS codes not coveredHCPCSNot Covered

A9291	Prescription digital behavioral therapy, FDA cleared, per course. No Medicare DMEPOS benefit category.
K1034	Provision of COVID-19 test, nonprescription self-administered use. No Medicare DMEPOS benefit category.

Functional reporting G-codes historicalCPT

G-codes

Functional reporting G-codes and related modifiers historically required for outpatient therapy claims (2013-2018)

Therapy billing codes referenced (examples)CPT/HCPCS

97150	Group therapy services (billing rules described)
92526	SLP example used in progress report example

Billing / Claims processing referencemixed

13X / 85X

Hospital bill types for outpatient therapy; ASC bill types and revenue guidance referenced

Screening HCPCS/G and CPTHCPCS|CPTCovered

G0106	Screening barium enema; alternative to G0104
G0120	Screening barium enema alternative to G0105
G0104	Screening flexible sigmoidoscopy
G0105	Screening colonoscopy high risk
G0121	Screening colonoscopy not high risk
G0328	iFOBT immunoassay
82270	gFOBT CPT
81528	sDNA Cologuard

Diabetic shoes & Lymphedema codes & limitsHCPCS|mixedCovered

A5513	(example DME codes referenced in DME section)
A6515	Gradient compression wrap with adjustable straps, full leg, custom. Benefit Category Determination = Lymphedema Compression Treatment Item.
A6519	Gradient compression garment for nighttime use

Home Infusion Therapy - Reference Codes for Drug Category AssignmentHCPCS|J-codes

No codes listed

Home infusion G-codes (professional service days)HCPCS

No codes listed

Provider Actions — Documentation, Billing & Compliance

Documentation Required

Document CPO services and time

Document CPO services and time: Ensure documentation includes start/stop times, detailed CPO services rendered, face-to-face encounter notes, and justification when services occur during a global surgical period. If furnished during an operative global period or as routine post-operative care, CPO services are not payable. Maintain physician orders and referrals when required.

CPO documentation & face-to-face prerequisite; not payable if routine post-op within global period or incident-to

Billing Rule

Consultation coding change (effective Jan 1, 2010)

Consultation coding change (effective Jan 1, 2010): Do not bill CPT consultation codes for outpatient or inpatient consultations for dates of service on/after 2010-01-01. Use appropriate office or inpatient evaluation and management codes instead and document reason for consultation, findings, and plan.

Background & Definitions

Background context: Chapter 15 enumerates the scope of Medicare Part B coverage and clarifies when Part B expenses are incurred (general rule and special rules for surgery/childbirth). It provides detailed policy and operational guidance for physician professional services — including the elimination of consultation CPTs for Medicare payment in 2010 and instructions to bill appropriate E/M or facility codes — and explains physician role requirements (exam/visualization) and settings of service. The chapter explains care plan oversight (CPO) definitions and requirements, teaching physician and resident/intern rules, and documentation expectations (when CNMs/NPs/PAs and others may review/verify rather than re‑document). It also frames billing and claims processing expectations (e.g., claims forms, remittance/appeal pathways) that serve as background for the detailed coverage criteria that follow in the manual.

Term	Definition
{"text":"CPO","status":""},{"text":"Supervision of home health or hospice patients requiring complex multidisciplinary care; billed only when physician who signed the plan furnishes ≥30 minutes of care plan oversight in the calendar month, documents dates and times, and meets prerequisites (face-to-face E/M within prior 6 months, not routine post-op/global, not incident-to).","status":""}
{"text":"Incident-to","status":""},{"text":"Items/services furnished as an integral, incidental part of a physician's professional service that are commonly included in the physician bill, furnished by the physician or auxiliary personnel under the physician's direct supervision; drug charge must be included in physician's bill and represent expense to physician.","status":""}
{"text":"Homebound","status":""},{"text":"Patient confined to home when BOTH: (1) Because of illness/injury needs supportive devices, special transport, or assistance or has condition medically contraindicating leaving home; AND (2) normal inability to leave home and leaving requires considerable and taxing effort; infrequent/short absences allowed.","status":""}
{"text":"DME","status":""},{"text":"Durable medical equipment: can withstand repeated use, primarily and customarily used for medical purpose, not generally useful absent illness/injury, and appropriate for use in the home.","status":""}
{"text":"Prosthetic Device","status":""},{"text":"Device that replaces all or part of an internal body organ or replaces function of a permanently inoperative/malfunctioning internal organ; furnished on physician's order; accessories/supplies necessary for effective use may be covered.","status":""}
{"text":"Infusion drug administration calendar day","status":""},{"text":"The calendar date on which professional home infusion therapy services were furnished in the patient's home to administer home infusion drug(s); the unit of single payment is per infusion drug administration calendar day.","status":""}
{"text":"Unit of single payment","status":""},{"text":"A bundled, single payment per infusion drug administration calendar day (varies by payment category) that covers all qualified home infusion therapy professional services (nursing, training/education, remote monitoring/monitoring) provided in the home on that day.","status":""}
{"text":"Maintenance therapy","status":""},{"text":"Ongoing care to prevent disease, promote health, or maintain/prevent deterioration; not considered medically reasonable/necessary for chiropractic (and denied) unless specific skilled-need criteria for therapy maintenance programs are met per policy (therapist skills required to design/instruct or to safely carry out complex maintenance).","status":""}

Preventive & Screening Services (AWV, Cancer Screening, Vaccines)

Colorectal Cancer Screening - Tests, Frequencies, and High-Risk Criteria

Colorectal cancer screening criteria — FOBT, flexible sigmoidoscopy, colonoscopy high-risk and not-high-risk, barium enema, follow-on colonoscopy after positive stool-based tests. Preserve frequency thresholds and high-risk ICD criteria.

FOBT: Screening FOBT (gFOBT 82270 or iFOBT G0328): covered for adults >=45 (effective 2023-01-01), frequency once every 12 months (>=11 months since prior); requires written order from attending physician (or PA/NP/CNS for claims on/after 2014-01-27).>=11 months

Patient verbal history acceptable for prior vaccination in other contexts; here order required.

Flexible Sigmoidoscopy: Screening flexible sigmoidoscopy (G0104): covered for adults >=45 (effective 2023-01-01) once every 48 months (>=47 months); performed by MD/DO or PA/NP/CNS; if lesion found requiring biopsy/removal bill diagnostic procedure instead.>=47 months

Therapy, Rehabilitation & Diagnostic Testing

Outpatient Therapy Documentation and Timing (plan, certification, progress report every 10 days, treatment notes)

Therapy-specific criteria: plan establishment, certification/recertification, progress report timing (every 10 treatment days), treatment note content, documentation requirements, functional reporting historical note.

Plan establishment: Plan of care must be established before treatment and include diagnoses, long-term goals, type/amount/duration/frequency, date and identity of person who established plan; may be established by physician/NPP or PT/OT/SLP.established before treatment

Evaluation and treatment may occur same day.

Certification timing: Certification requires dated signature; obtain as soon as possible or within 30 days of initial treatment; verbal order must be signed within 14 days; initial certification covers up to 90 calendar days or duration of plan whichever less; recertify at least every 90 days or when significant modification occurs; delayed certification acceptable with documentation.initial <=30 days; verbal signed <=14 days; recertify <=90 days

DME, Prosthetics & Lymphedema Compression Items

DME Coverage Requirements, Definitions, Repairs, Home Definition, and Miscellaneous Code Determinations

DME coverage requirements and definition (repeated-use, medical purpose, home-appropriate), repairs/maintenance/replacement rules, beneficiary's home definition, benefit category determination rules for miscellaneous codes (claim-by-claim).

DME general coverage: DME reimbursable if item meets definition: withstand repeated use; primarily and customarily used to serve medical purpose; not useful absent illness/injury; appropriate for use in home; and is necessary and reasonable for treatment.definition criteria all met

Repairs/maintenance/replacement: Repairs to owned equipment covered when necessary; routine periodic servicing by owner not covered; replacement for loss or irreparable damage covered; reasonable useful lifetime considerations; repair vs replacement cost rules and warranty exclusions apply.repair vs replacement cost >60% relevant for prosthetics

CMN or physician order may be required for replacement.

Home Infusion & Drug Coverage Rules

Home Infusion Therapy Services - Supplier Eligibility, Plan, Drugs, Payment Categories, Bundling, First-Visit Rules, Review Triggers

Home infusion supplier/provider eligibility, plan of care elements, required professional services (7/24), definition of home infusion drug (>=15 minutes, parenteral IV/SC through DME pump), linkage requirement that drug be billed under DME benefit within 30 days, payment categories 1-3 definitions, single bundled payment per infusion drug administration calendar day, first-visit vs subsequent visit/60-day gap rules, and medical review triggers.

Supplier eligibility: Qualified home infusion therapy supplier must be accredited, furnish services 7-days/24-hours, may subcontract, meet 42 CFR 486 Subpart I and 42 CFR 414 Subpart P requirements.7-day/24-hour availability; accreditation

Supplier may be pharmacy, physician, or other enrolled provider.

Plan of care elements: Physician-established plan must prescribe type/amount/duration of services, specific medication/dosage/frequency, professional services to be used; orders specify frequency and discipline; plan signed/dated by ordering physician prior to claim and upon changes; periodic review by physician.physician signature prior to claim

Physician Opt-Out / Private Contracts — Rules & Actions

Opt-Out Rules: Affidavits, Private Contracts, Emergency Exceptions, GJ Modifier, Contractor Actions and Consequences

Opt-out rules consolidated: who can opt-out, affidavit requirements, automatic renewals, effective dates, private contract content/requirements, emergency/urgent exceptions (12-hour urgent definition), GJ modifier use, billing/limiting charge rules, contractor actions on suspected failure to maintain opt-out (45-day development), consequences of failure, cancellation/early termination rules, and remittance messaging/claim adjustment codes (27/PR/MA47 variants).

Who can opt-out and affidavit: Only physicians/practitioners listed in §40.4 (MD, DO, DDS, DPM, OD if authorized; PAs, NPs, CNSs, CRNAs, CNMs, CPs, CSWs, RDs) may opt out; valid affidavit must be written, signed, include identification, NPI/TIN, attestations, file with all MACs; affidavits filed on/after 2015-06-16 auto-renew every 2 years unless cancelled 30 days prior.file with all MACs; auto renew every 2 years

Participating physicians must file at least 30 days before next calendar quarter for effective quarter start.

Private contract content & timing: Private contract must be written, readable, state opt-out, patient accepts payment responsibility and waives Medicare claims, not entered during emergency/urgent care, provided before services, retained for opt-out period, available to CMS; initial opt-out period begins on affidavit signature if filed within 10 days of first private contract.

Chiropractic Services — Coverage & Documentation

Chiropractic Services - Scope, Licensing, X-ray, Maintenance Exclusion, Education Paths, Contraindications

Chiropractic coverage criteria: coverage limited to manual spinal manipulation for subluxation, licensure requirements, x-ray usage (documentation vs payable), devices not separately payable, education/licensure pathways (mutually exclusive branches), maintenance therapy exclusion, and contraindications to dynamic thrust.

Scope and licensure: Coverage limited to manual spinal manipulation to correct subluxation; chiropractor must be licensed in state where services furnished and meet uniform minimum standards; other services ordered/furnished by chiropractor not covered.licensure and standards met

If chiropractor orders/takes/interprets x-ray it may be used for documentation but those x-ray services are not payable when furnished by chiropractor.

Education/licensure pathways: For those licensed prior to July 1, 1974: meet three minimum standards (HS equivalent, graduation from State-approved chiropractic college with specified coursework, pass State exam). For those commencing after June 30, 1974: meet prior three plus 2 years pre-chiro college-level study, completion of 4-year chiropractic course >=4,000 hours, and be over 21 years.

Dental & Foot Care — Exclusions and Exceptions

Dental Services Exclusion and Exceptions (inpatient and inextricably linked circumstances)

Dental exclusion rules and statutory exceptions (inpatient situations, services inextricably linked to covered medical services such as pre-transplant oral exam). Include examples where dental services may be payable and emphasize contractor claim-by-claim discretion.

General exclusion: Items/services in connection with care, treatment, filling, removal, or replacement of teeth or structures directly supporting teeth are not covered subject to exceptions (42 CFR 411.15(i)).

Statutory inpatient exceptions: Two statutory exceptions allow payment for inpatient hospital services in connection with dental services when hospitalization is required because of underlying medical condition/clinical status or severity of dental procedure.inpatient necessity exceptions

Inextricably linked exceptions: Some medical services necessary to diagnose/treat underlying medical condition may require dental services and the dental exclusion may not apply when dental services are inextricably linked to and substantially related/integral to clinical success of covered medical services (e.g., oral exam and treatment prior to organ transplant, cardiac valve replacement, tumor resection reconstruction when integral to procedure).

Provider Qualifications & Enrollment

Provider qualification and enrollment highlights: covered nonphysician and behavioral health provider types have defined degree, licensure/certification, and supervised‑experience requirements. Examples: Clinical Psychologists (CP) require a doctoral degree and State licensure at the independent practice level; Clinical Social Workers (CSW) require a master’s or doctoral degree plus at least two years supervised clinical social work or, where State law differs, equivalent supervised practice; Certified Nurse‑Midwives (CNM), Physician Assistants (PA), Nurse Practitioners (NP), and Clinical Nurse Specialists (CNS) must meet their profession‑specific education, certification, and State authorization rules to bill. Marriage and family therapists (MFT) and mental health counselors (MHC) require a master’s or doctoral degree, State licensure/certification, and at least 2 years (or 3,000 hours) of post‑master’s supervised clinical experience; these provider types were added to Part B policy by the 2024 transmittal updates. The manual specifies that some practitioners must accept assignment and that certain direct‑billing changes (e.g., PA direct billing effective Jan 1, 2022) affect who may bill directly. Enrollment as a DMEPOS supplier is required for suppliers furnishing certain supply categories (see lymphedema/compression items).

Supplier enrollment and supplier‑type requirements: suppliers of DMEPOS items used in these benefits must be enrolled and meet supplier standards where indicated. Examples: lymphedema and gradient compression items must be prescribed and furnished by an enrolled DMEPOS supplier (all suppliers — including PTs or others furnishing bandaging systems — must enroll to be paid under Part B). ASCs that furnish non‑implantable DME or prosthetic devices (other than IOLs) are treated as suppliers and must follow DME supplier rules and bill the appropriate DME MAC for those items. Home infusion suppliers must be accredited and meet regulatory requirements (42 CFR Subpart I) and the home infusion benefit references applicable CFR sections and supplier accreditation/conditions for home infusion services and payments.

Medicare Determinations & NCD References

Determination name	Type (NCD/mixed)	Effective date	Number
{"text":"IHS exception (Section 1880)","status":""},{"text":"NCD","status":""},{"text":"2005-01-01","status":""},{"text":"Section 1880, Social Security Act","status":""}
{"text":"DMEPOS Benefit Category Determinations (selected codes)","status":""},{"text":"NCD/mixed","status":""},{"text":"2023-2026","status":""},{"text":"(various HCPCS BCDs published by CMS)","status":""}
{"text":"Pulmonary Rehabilitation NCD","status":""},{"text":"NCD","status":""},{"text":"2010-01-01","status":""},{"text":"Medicare coverage criteria for PR (see 231/42 CFR references)","status":""}
{"text":"Cardiac Rehabilitation NCD","status":""},{"text":"NCD","status":""},{"text":"2010-01-01","status":""},{"text":"Medicare coverage criteria for CR (see 232/42 CFR references)","status":""}
{"text":"CR/ICR coverage (regulation)","status":""},{"text":"NCD/regulatory","status":""},{"text":"2010-01-01","status":""},{"text":"42 CFR 410.49","status":""}

Revision History

12-31-20 (issued) / effective 01-01-21 / implementation 01-04-21material_change

Rev. 10547 issued 12-31-20 effective 01-01-21; implementation 01-04-21; CR# 11880. Billing for Home Infusion Therapy Services On or After January 1, 2021 (Transmittal R10547BP).

01-11-2024 (issued) / effective 01-01-24 / implementation 02-12-24material_change

Issued 01-11-2024, effective 01-01-24, implementation 02-12-24; CR# 13469. Updates to Pub. 100-02 for Marriage and Family Therapists and Mental Health Counselors (Transmittal R12448BP).

historical indexinformationalLatest

Policy Summary

PayerCapital Bluecross

PolicyChapter 15 - Covered Medical and Other Health Services (Medicare Part B benefit policy)

Policy CodePolicy N/A

Change TypeTransmittal updates (revised and informational)

Effective Date

Next Review Date

Key ActionPhysician billing CPO must document services furnished and the date and length of time associated with those services in the patient's record.

SourceLink

On This Page

Include time-based documentation (see time threshold node).

Services are furnished in addition to typical office visits or procedural services and are not duplicative of other covered services for the same time period.

Time threshold

The practitioner documents cumulative non-face-to-face care plan oversight time spent in a calendar month equal to or greater than the CPT-defined threshold for the specific CPO code billed (e.g., 30 minutes).>= calendar-month threshold

ALL of the following

CPO services are not billed in bundles with another service for the same episode of care when policy or code descriptors prohibit separate reporting.
If the practitioner delegates portions of care coordination to qualified personnel, the practitioner must document direction, review, and clinical decision-making sufficient to support billing.

Physician Services - General Coverage Conditions

Physician services are covered when ALL of the following general conditions are met:

ALL of the following

The service is furnished by a physician or by another practitioner whose services are payable under the benefit when applicable.
The service is reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member.
The service is within the scope of practice of the furnishing practitioner and meets applicable State and Federal requirements.
Documentation supports the medical necessity, nature, extent, and time of the service and identifies the beneficiary receiving the service.
Services furnished incident to a physician’s professional service meet the incident-to supervision and billing requirements (see Incident-to coverage requirements group).

ALL of the following

For surgical services, the physician documents the rationale for the procedure and that non-surgical alternatives were considered when appropriate.
For evaluation and management services, documentation includes history, exam, medical decision making, and, where relevant, time or counseling documentation per coding guidance.

Consultations (billing rules)

Billing rules for consultations:

ALL of the following

CPT consultation codes were discontinued for Medicare billing in 2010; do not submit CPT consultation codes for dates of service on or after 2010-01-01.
When consultation-like services are provided, bill the appropriate E/M or other service code that best describes the service furnished, with documentation reflecting the nature of the service and who requested it.
If a consultation results in a transfer of care responsibility, document acceptance of transfer by the consulting practitioner when applicable.

Patient-Initiated Second Opinions — coverage conditions

Patient-initiated second opinions are covered when ALL of the following are met:

ALL of the following

The beneficiary requests a second opinion and the second opinion service is furnished by a qualified practitioner.
The second opinion pertains to the diagnosis or recommended treatment for an active medical condition.
Documentation identifies that the examination was a second opinion, summarizes findings, and states any agreement or disagreement with the original plan and subsequent recommendations.

Concurrent Care — Criteria Governing Concurrent Attending Physicians

Concurrent care — criteria for recognition of multiple attending physicians:

ALL of the following

Concurrent attending physicians may each be recognized and may bill for separately provided medically necessary services when they each perform distinct, non-overlapping professional services that are documented and necessary.
Documentation must clearly delineate the separate roles, services furnished, and medical necessity by each concurrent attending practitioner.
Services that are duplicative, bundled, or for the same time and same purpose may be denied as not reasonable and necessary.

Care Incurrence Rules - Surgery and Childbirth

Care incurrence rules for surgery and childbirth — covered when ALL of the following are met:

ALL of the following

The surgical or obstetric procedure is medically necessary and reasonable for the beneficiary’s condition, as documented in the record.
Preoperative and postoperative care billed separately conforms to applicable global surgery rules and postoperative care periods; services included in global packages are not separately payable unless an exception applies.
For childbirth, delivery and associated obstetric care are billed and documented per the applicable obstetric global rules and coding guidance.

Custom-made Items Ordered But Not Furnished - Date of Incurred Expense

Custom-made items ordered but not furnished — date of incurred expense determination (logical branches preserved):

ANY of the following

Expense is considered incurred on the date the supplier orders the custom-made item from a manufacturer or lab if the supplier documents the order and the beneficiary was eligible at that time.
Expense is considered incurred on the date the beneficiary signs an order or other document committing to the purchase, if that is earlier and properly documented.
If an item is ordered but not furnished because beneficiary ineligibility or other insurer denial occurs later, the date of the documented order governs incurred expense status, subject to policy limits and proof of intent to acquire.

Investigational IOL Coverage Rules

Investigational intraocular lens (IOL) coverage rules — eye services in an FDA-monitored IOL study are covered when ALL of the following are met:

ALL of the following

The service is furnished in the context of an FDA-approved or FDA-monitored investigational device exemption (IDE) study in which Medicare allows coverage of routine care and device-related costs under specific conditions.
The service represents routine care that would otherwise be covered under the Medicare benefit outside the study, and it is not solely attributable to investigational aspects of the IOL.
Documentation demonstrates that participation in the study does not constitute the primary reason for the service and the service meets usual coverage and medical necessity criteria.

Concurrent Care Recognition for Ophthalmology

Concurrent care recognition for ophthalmology — brief coverage rule:

ALL of the following

When an ophthalmologist provides a distinct professional service (e.g., surgical or medical management) concurrently with another attending physician, separate payment may be allowed when documentation supports separate, non-overlapping medically necessary services.

Chiropractic Services Coverage Criteria

Chiropractic services coverage criteria — main branch plus education/licensure pathways and maintenance exclusion:

ALL of the following

Manual manipulation of the spine to correct a subluxation is covered when there is documentation of subluxation demonstrated by x-ray or by a physician’s exam and when medical necessity is established.
Initial evaluation documents history, examination findings, diagnosis of subluxation, treatment plan, expected improvement, and measurable functional goals.
Subsequent visits must document ongoing necessity, response to treatment, and objective findings; maintenance therapy that lacks expectation of improving or restoring function is not covered.

Education / Licensure pathways (mutually exclusive)

Coverage of specific chiropractic services depends on the provider meeting Medicare’s enrollment and licensure requirements for furnishing and billing chiropractic care in the applicable setting.
Alternate pathway: when a non-chiropractic practitioner furnishes manipulation, coverage follows the practitioner-specific qualification and documentation rules rather than chiropractic-only pathways.

ALL of the following

Maintenance therapy — not covered: repetitive courses of chiropractic care provided solely for the purpose of ongoing symptomatic relief without objective signs of clinical improvement or function restoration.

Beneficiary Agreements, Opt-Out, and Private Contract Rules

Beneficiary agreements, opt-out, and private contract rules — coverage when ALL/ANY as structured below:

ALL of the following

A physician or practitioner may elect to opt out of Medicare and enter into private contracts with Medicare beneficiaries only if they meet opt-out eligibility requirements and follow all affidavit, filing, and notification rules.
The practitioner must submit the required affidavit attesting to compliance with opt-out conditions and maintain up-to-date records in the opt-out system as specified by Medicare administrative guidance.
Private contracts must include required language, be executed voluntarily by the beneficiary, and not be used in instances where Medicare payment would otherwise be mandatory or where prohibited by other program rules (see Emergency or urgent care exceptions).

ALL of the following

Opt-out maintenance and response requirements: practitioners who opt out must timely renew and maintain opt-out status per CMS rules, respond to beneficiary and plan inquiries, and update the National Supplier Clearinghouse/opt-out system when changes occur.
System and data maintenance requirements: practitioners must ensure accurate system entries (NPIs, PTANs where applicable), notify Medicare Administrative Contractors (MACs) or other designated entities of changes, and follow transmittal guidance for informing Medicare Advantage organizations and NSC when required.

ALL of the following

Opt-out scope and implications: when properly opted out, the practitioner and beneficiary are outside the Medicare assignment/payment relationship for services covered by the private contract; Medicare will not make payment to the practitioner, and beneficiaries accept financial responsibility as described in the private contract.
Opt-out effective dates and filing rules: opt-out takes effect when CMS acknowledges the affidavit per applicable filing timelines; practitioners must adhere to filing windows and required notifications to make opt-out effective for a given period.

ALL of the following

Actions when failure to maintain opt-out or wrongly filed claims: failure to maintain required opt-out filings or filing claims contrary to opt-out rules may result in denials of payment to practitioners, denials to beneficiaries, and potential sanctions as described in program transmittals.
Cancellation, early termination, and reinstatement of opt-out: procedures exist for voluntary cancellation, early termination for cause, and reinstatement; practitioners must follow filing and notice requirements and understand effective dates for each.

ALL of the following

Emergency or urgent care exceptions and billing requirements: private contracts do not apply to emergency or urgent care situations as defined by CMS; in such cases beneficiaries retain Medicare claim rights and practitioners must bill Medicare according to program rules.
Remittance/notice language for denials and Appeals and determinations: when claims are denied related to opt-out or private contract issues, the contractor’s remittance advices and notices must include required explanatory language; beneficiaries and practitioners retain appeal rights per CMS appeals procedures.

Drugs and Biologicals - General Coverage Criteria and Related Drug Rules

Drugs and biologicals — general coverage criteria and drug-related rules consolidated (compendia, definitions, self-administered determination, incident-to, off-label oncology guidance):

ALL of the following

Drugs and biologicals are covered when they are reasonable and necessary for the diagnosis or treatment of illness or injury and otherwise meet program coverage rules and limitations.
A drug or biological must meet the policy definition of a drug/biological and any applicable benefit category determinations to be payable under Medicare Part B or other applicable benefit categories.

ALL of the following

Compendia inclusion requirement: for off-label uses of drugs and biologicals in anti-cancer chemotherapeutic regimens, coverage determination relies on inclusion of the off-label indication in an approved list of compendia; MACs follow the CMS process for maintaining and updating the compendia list.
Off-label use in anti-cancer chemotherapeutic regimens — medically accepted indications: off-label oncology uses may be covered when the use is listed in an approved compendium or otherwise meets criteria for medically-accepted indications supported by sufficient clinical evidence.
Peer-reviewed literature support for off-label use: when compendia listing is not dispositive, peer-reviewed medical literature that demonstrates adequate evidence of effectiveness and safety can support coverage for off-label uses as outlined in CMS guidance.

ALL of the following

Determining 'Usually Self-Administered' (exclusion): a drug or biological is usually self-administered and excluded from Part B coverage when it is customarily self-administered by the patient and does not require administration in a clinical setting; the MAC uses evidentiary criteria (route, complexity, need for medical supervision) and specific categories to determine status (see Self-Administered Drugs & Specific Categories).
Self-administered threshold and MAC responsibilities: when a drug is determined to be usually self-administered by >50% of patients for the indication, it is generally classified as self-administered; MACs are responsible for determinations and for maintaining lists and guidance used in coverage decisions.

ALL of the following

Incident-to rules and administered/incident-to requirements: coverage of drugs and supplies furnished incident to a physician’s professional service requires that services/supplies be an integral, incidental, and commonly rendered part of the physician’s service; supervision and billing rules apply per the Incident-to coverage requirements group.
Reasonable and necessary: approved and unlabeled use: drugs used for FDA-approved indications are covered when reasonable and necessary; unlabeled (off-label) uses may be covered when supported by compendia or sufficient medical evidence per policy for anti-cancer regimens and other specified categories.

ALL of the following

Antigens (allergen extracts): coverage of antigen preparations follows specific antigen guidance; preparations intended for therapeutic use may be covered when reasonable and necessary and provided per applicable immunotherapy coverage rules.

Incident-to Coverage Requirements

Incident-to coverage requirements — services and supplies furnished incident to a physician’s professional services are covered when ALL of the following are met:

ALL of the following

The service or supply is an integral, though incidental, part of the physician’s professional service and commonly rendered without charge or included in the physician’s bill to the patient.
The service or supply is furnished under the physician’s direct supervision in the office or clinic setting (physician present in the office suite and immediately available) unless specific exceptions for home/outreach apply.
The physician must initiate the plan of care and remain actively involved in treating the beneficiary; delegated tasks must be performed by qualified personnel and appropriately supervised and documented.
The expense is incurred by and billed by the physician (or group) under whose supervision the service is furnished and is the responsibility of that physician for purposes of payment.

Therapy Coverage: Outpatient Therapy (PT/OT/SLP) Coverage Conditions and Documentation

Outpatient therapy (PT/OT/SLP) coverage conditions, plan of care, certification/recertification, maintenance vs rehabilitative therapy, documentation and progress report frequency:

ALL of the following

Services are covered when they are reasonable and necessary for the treatment of an injury, illness, or resulting functional limitation and when expected to improve or maintain the patient’s condition in a way that is consistent with established goals.
Plan of care establishment requirements: a written plan of care must be established by a physician or other authorized practitioner; it must specify diagnoses, long-term and short-term treatment goals, types, frequency and duration of therapy, and the signature and date by the certifying practitioner.
Therapy episode and certification interval definitions: a therapy episode is defined by the initial certification period (certification <= 90 days is standard) with recertification required when additional services beyond the certification period are necessary; allowable delayed certification windows apply when services begin before the certification signature under specific conditions.
Certification and recertification of plan: the certifying practitioner must re-evaluate and re-certify need for continued therapy at intervals not to exceed the certification period and document progress and medical necessity for continued services.
Conditions for reasonable and necessary therapy: therapy must be specific, safe, and effective for the beneficiary’s condition, require skilled intervention, and be expected to result in measurable improvement in a reasonable and generally predictable period of time.
Rehabilitative therapy coverage: covered when the therapy is expected to restore function or to materially improve or prevent deterioration in patients with progressive conditions.
Maintenance therapy coverage: maintenance programs may be covered when documentation shows ongoing skilled professional services are necessary to maintain a beneficiary’s functional status and when the services meet other coverage criteria; simple routine maintenance without skilled intervention is not covered.
Not covered: maintenance program services that do not meet criteria: repetitive, custodial, or convenience services without skilled therapeutic intervention or measurable goals are non-covered.
Timing and frequency of documentation: progress reports are required every 10 treatment days (or more frequently when clinically indicated) and must document objective progress toward goals; certification intervals and delays must be documented per policy thresholds.
Content requirements: evaluation/re-evaluation/plan of care: initial evaluation and subsequent re-evaluations must document the beneficiary’s functional limitations, measurable goals, specific interventions, and anticipated outcomes.
Progress report content requirements: progress reports must include type, amount, frequency, and duration of services furnished; response to treatment, changes to the plan, and justification for continued skilled therapy.
Assistant participation and reporting: therapy assistants may provide services as allowed by state practice acts, but supervising therapists must ensure oversight, documentation of skilled services, and must sign and date records per applicable requirements.
Documentation requirements for therapy services: complete records must justify medical necessity, frequency, duration, and skilled nature of services; incomplete records may result in denial.
Functional reporting (G-codes and severity modifiers) applied to dates of service 2013-01-01 through 2018-12-31 per historic reporting requirements; current functional reporting follows the applicable program instructions for reporting periods.

Pulmonary Rehabilitation (PR) Coverage Criteria

Pulmonary rehabilitation (PR) coverage criteria — patient eligibility, program components, session limits, and supervision standards:

ALL of the following

Patient eligibility: beneficiary has chronic respiratory disease for which PR is reasonable and necessary, and the beneficiary is capable of participating in the program and demonstrates potential for measurable improvement or stabilization of functional status.
Program components: PR must include comprehensive treatment including exercise training, education, and psychosocial support consistent with program standards and individualized plan of care.
Session limits: standard coverage is up to 36 sessions; additional sessions beyond 36 require MAC (contractor) approval based on documentation of ongoing medical necessity and objective benefit.
Supervising practitioner standards: PR must be furnished under appropriate practitioner supervision with qualified personnel providing therapies and documented oversight by the supervising practitioner.

Cardiac Rehabilitation (CR/ICR) Coverage Criteria

Cardiac rehabilitation (CR) and intensive cardiac rehabilitation (ICR) coverage criteria — indications, components, session limits, and medical director qualifications:

ALL of the following

Covered indications: CR/ICR is covered for beneficiaries who meet established qualifying diagnoses (e.g., recent MI, coronary artery bypass graft, stable angina, heart valve repair/replacement when indicated, heart transplant, or other specified indications per program guidance).
Required components: CR/ICR programs must provide physician-supervised exercise, cardiac risk factor modification, education, and psychosocial support as part of a structured program and individualized plan of care.
Session limits: coverage generally allows up to a specified number of sessions (e.g., 36 standard sessions); ICR may have a different session allocation and requires program approval for intensive models; additional sessions require medical review and MAC approval with documentation of continued benefit.
Medical director qualifications and supervision: programs must have a qualified medical director and meet supervision standards, including practitioner oversight of program activities and protocols. For advanced dysfunction (e.g., EF <= 35%), additional documentation and program-level review may be required.

Home Infusion Therapy Services - Coverage and Billing Rules

Home infusion therapy services — supplier and benefit eligibility, plan of care requirements, home infusion drug definition, payment categories, and visit rules:

ALL of the following

Supplier and benefit eligibility: home infusion therapy suppliers must meet supplier qualifications to bill under the home infusion benefit distinct from the DME benefit; beneficiaries must meet patient eligibility criteria for home infusion therapy.
Plan of care requirements: a comprehensive plan of care must be established and periodically reviewed, documenting the infusion drug, indications, dosing, monitoring, and required professional services including nursing and pharmacist oversight.
Home infusion drug definition: a home infusion drug is defined by program rules and generally includes drugs that require preparation or administration services of at least 15 minutes of skilled professional time per administration.
Payment categories and bundled payment: home infusion drugs are assigned to payment categories; the payment structure includes a single bundled payment per infusion drug administration calendar day covering specified services related to drug administration and supplies.
First-visit vs subsequent visit rules: the initial visit for a home infusion therapy episode may be billed as a first-visit payment when it meets criteria; subsequent visits are reimbursed under subsequent visit rules. A gap of >= 60 days in services may permit a new first-visit billing; drug billing windows (e.g., 30-day drug billing) apply for certain categories.
Medical review triggers: claims that exceed standard session counts, show unusual utilization patterns, or lack required documentation may be subject to medical review by the MAC or designated reviewer.

Immunizations Coverage (Pneumococcal, Hepatitis B, Influenza, COVID-19)

Immunizations coverage cluster (pneumococcal, hepatitis B, influenza, COVID-19) — conditions and timing:

ALL of the following

Pneumococcal vaccines: guidance includes use of PCV15 or PCV20 followed by PPSV23 as indicated. When PCV15 is used, PPSV23 should be administered >= 1 year later for most adults or >= 8 weeks for certain immunocompromised individuals per schedule; PCV20 may be used as a single dose per guidance.
Hepatitis B vaccine: coverage is provided for beneficiaries at high and intermediate risk groups per specified criteria; updated guidance effective Jan 1, 2025 expands or clarifies eligible risk categories as noted in program materials.
Influenza vaccine: influenza immunizations are covered each influenza season; coverage and coding align with current seasonal vaccine formulations and program instructions.
COVID-19 vaccines: coverage follows applicable public health and CMS guidance for effective dates and eligible populations; check current CMS/COVID guidance for time-limited program changes.

In-home Additional Payment for Preventive Vaccine Administration

In-home additional payment for preventive vaccine administration — eligibility and documentation requirements:

ALL of the following

Eligibility conditions: an additional payment for in-home vaccine administration is allowed only when the visit is for the sole purpose of administering a covered preventive vaccine and the beneficiary is unable to leave home due to barriers to travel (e.g., homebound status, lack of transportation, mobility impairment).
Documentation requirements: the medical record must document the sole purpose of the visit, the specific barrier(s) preventing the beneficiary from accessing office-based vaccination, and the vaccine administered including date and lot information.
Examples of barriers: documentation may cite homebound status, significant mobility limitations, or lack of reasonable transportation options that prevent the beneficiary from receiving the vaccine in an office or clinic setting.

Less Than Effective Drugs and Compounded Drugs Produced in Violation of FFDCA

Less-than-effective drugs and compounded drugs produced in violation of the FFDCA — denial conditions:

ALL of the following

Drugs that the FDA has determined are less than effective (NOOH) are not covered; claims for such drugs will be denied when FDA has issued formal notice that the product lacks effectiveness.
Compounded drugs produced in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA) are not payable. When compounding practices or sources fail to meet federal requirements, payment will be denied and providers may be subject to further administrative action.

Consultation coding change (no CPT consult codes after 2010)

Documentation Required

Opt-out affidavit filing, private contract maintenance, and MAC notification

Opt-out / private contract and MAC notifications: Maintain a filed Opt-Out Affidavit and keep MACs informed of opt-out status. When electing opt-out, submit the Opt-Out Affidavit to the contractor and keep records of the opt-out election. Maintain private contracts (written agreements) with beneficiaries and preserve proof of state authorization and practitioner qualifications. Publish and maintain a list of self-administered excluded drugs and the process for exclusion.

Submit Opt-Out Affidavit for Opt-Out Election
Maintain Opt-Out Provider Data and Private Contracts
Publish self-administered exclusion process and drug lists

Prior Authorization

Respond promptly to MAC development letters

Respond to MAC development letters and maintain compliance: If a MAC issues a development letter for failure to maintain opt-out requirements or other deficiencies, respond timely with required evidence (opt-out affidavit, private contract, enrollment, or corrective actions). Failure to respond may lead to denial or cancellation of opt-out status and potential requirement to refund payments for early termination.

Respond to Development Letter for Failure to Maintain Opt-Out
Refunds on Early Termination

Billing Rule

Emergency/urgent care by opt-out providers — GJ modifier and charging rules

Use GJ modifier and limiting charge rules for emergency/urgent opt-out services: When an opt-out provider furnishes emergency or urgent services, append the GJ modifier as required and follow limiting charge/assignment rules appropriate to emergency/urgent situations. Maintain documentation that services met emergency/urgent definitions and preserve beneficiary notification and billing records.

Use GJ Modifier for Emergency/Urgent Services by Opt-Out Provider
Limiting Charge / Assignment Rules in Emergency/Urgent Situations

Denial Risk

Watch remittance and denial codes for opt-out related denials

Remittance and denial codes for opt-out issues: For denials related to opt-out or private contract noncompliance, expect remittance/notice codes such as 27 (patient not covered), PR (denied as not covered), and MA47 (opt-out/noncompliant) on claim adjudication. Use these codes to track required follow-up and appeals.

Remittance claim adjustment codes (27/PR/MA47) for opt-out denials
Claims Denial Notices to Opt-Out Physicians and Beneficiaries

Documentation Required

Follow Incident-to billing rules and supervision requirements

Incident-to billing requirements: Services furnished incident-to a physician/NPP must meet all incident-to rules: physician supervision level, documented plan of care and orders, services integral to the physician's professional service, and proper employment/assignment. CPO and other services billed incident-to are not payable if they are routine post-operative care within a global period or otherwise outside incident-to conditions.

Incident-to billing rules and supervision requirements
CPO not payable if routine post-op within global period or incident-to

Prior Authorization

Document compendia support for off-label anti-cancer uses and submit change requests when necessary

Drug compendia, off-label anti-cancer uses, and compendia change requests: For off-label anti-cancer drug uses, document physician rationale and rely on Medicare-accepted compendia. If a compendia change is needed, submit a compendia change request through the contractor process. Maintain support for medically-accepted indications and be aware of requirements for anti-cancer agents.

Support for Off-Label Anti-Cancer Uses
Compendia Change Requests

Documentation Required

Provider notice and publication requirements for drug coverage changes

Publish provider notice and 45-day rule for drug denials: For drugs considered self-administered or non-covered by policy, publish the list and provide providers a 45-day notice before a denial policy is implemented. Maintain and publish the process for provider notice and appeals as required.

Publish self-administered exclusion process and drug lists
45-day provider notice before denial

Documentation Required

Create and maintain home infusion plan of care and coordinate DME drug billing

Home infusion plan of care and DME linkage: Establish and record a home infusion plan of care prior to initiating services. The plan must be periodically reviewed and must link professional nursing services to any DME drug billing by the DME supplier. Coordinate notification of infusion options and ensure billing follows payment-category single-payment-per-calendar-day rules, with distinction between initial and subsequent visits.

Home infusion plan of care requirements
Home infusion drug billing linkage and single payment per calendar day
Notification of infusion options; Coordination with DME supplier
IVIG home infusion bundled payment instructions

Documentation Required

Document EPO patient selection, training, and home therapy records

EPO/EPO training, selection, and records: For erythropoietin (EPO) and EPO home therapy, document patient selection, training, and EPO home therapy records. Ensure EPO coverage criteria are met and training/selection documentation is retained.

EPO Home Therapy Records
EPO Training and Patient Selection

Documentation Required

Therapy plan of care — establish, certify, and document timely

Therapy plans of care, certification timing and documentation frequency: Establish and record an individualized therapy plan of care before treatment begins. Physician or NPP certification of the plan must be documented — initial certification timing is required (or delayed certification justified and documented). Periodic recertification and physician review of significant changes are required. Missing certification or physician/NPP signature risks denial.

Physician/NPP certification of therapy plan of care
Plan of care contents and timing; establish and record plan of care
Delayed certification justification and denial risk for missing certification
Plan changes and physician notification; maintain required documentation

Documentation Required

Document therapy evaluation, functional reporting, and session-level details

Therapy clinical documentation and billing details: Document evaluation and re-evaluation notes, G-code and severity modifier selection in the medical record, individualized treatment plans, physician/NPP active participation, treatment note content, and record unbilled timed services. Record changes to treatment between progress reports and preserve documentation for medical review. Obtain MAC approval for extended PR/CR/ICR sessions and ICR site enrollment when required.

Evaluation and re-evaluation documentation; G-code and severity modifier documentation
Document clinician active participation; individual treatment plan and physician review
Record unbilled timed services and changes to treatment between progress reports
MAC approval for extended PR sessions and ICR site enrollment for extended CR sessions

Billing Rule

AWV billing and SDOH optional element documentation

AWV and SDOH G0136 (modifier -33) use: When furnishing an Annual Wellness Visit (AWV) with optional Social Determinants of Health assessment (G0136), append modifier -33 as appropriate and document agreement with the patient for optional elements such as Advance Care Planning. Record date-of-service and ensure correct billing for preventive services.

AWV + G0136 modifier -33 instructions; SDOH date-of-service considerations

Documentation Required

DSMT and KDE: certify, document attendance, and follow session limits

DSMT and KDE documentation and billing limits: For Diabetes Self-Management Training (DSMT) and Kidney Disease Education (KDE), obtain physician certification/referral, document attendance and outcomes, use correct billing forms and revenue codes, and follow time-unit edits. Adhere to session limits and document the physician referral for KDE. Maintain attendance rosters and outcomes assessments when required.

DSMT physician certification/referral and attendance documentation
DSMT time-unit CWF edits and special claims processing instructions
KDE physician referral documentation and session billing; KDE outcomes assessment availability

Documentation Required

Obtain and document physician certification for therapeutic shoes for diabetes

Diabetic shoes and certification: Require physician certification that beneficiary meets coverage conditions before ordering or furnishing diabetic shoes. Document prescription/furnishing, annual limits, and replacement justification. Ensure supplier enrollment and confirm replacement frequency limits are met.

Physician certification for diabetic shoes; prescription and furnishing documentation
Diabetic shoes annual limits and replacement justification

Documentation Required

Chiropractic documentation requirements and AT modifier use

Chiropractic billing and AT modifier: For chiropractic active/corrective treatment, document initial visit findings and active care elements. Use the AT modifier for active treatment services; maintenance therapy is at risk for denial. Provide ABNs and use GA/GZ modifiers as required when noncovered services are furnished.

Chiropractic initial visit documentation and AT modifier required for active/corrective treatment
Maintenance chiropractic care denial risk; ABN and GA/GZ modifier guidance

Documentation Required

Document and justify sleep testing beyond standard limits

Sleep testing documentation beyond standard sessions: Document medical necessity for sleep testing beyond standard session counts, maintain attending physician orders and referrals, and record interpreting physician documentation. Justify in-home testing versus home health agency availability and provide rationale for independent laboratory home or institutional visits. Telephone or electronic orders must be documented per contractor rules.

Document medical necessity for sleep testing beyond standard sessions
Maintain attending physician orders and referrals for sleep clinic testing
Independent lab home/institution visit justification; telephone/electronic orders; interpreting physician documentation

Documentation Required

DME/prosthetics supplier enrollment, orders, and date-of-service rules

DME, prosthetics, and supplier enrollment rules: Ensure DME suppliers enroll to bill (including lymphedema supplies) and adhere to Date of Service rules — do not bill for items delivered before coverage or outside home settings when home-only coverage applies. For prosthetic devices, secure physician orders and document replacement justification and frequency limits. Lymphedema suppliers must be enrolled; follow replacement frequency constraints.

DME supplier enrollment for lymphedema items; DME Date of Service Rules
Physician order requirement for prosthetic devices; replacement justification and frequency limits
No payment for nonhome or precoverage delivery

Documentation Required

IHS, ASC, investigational IOLs, and institutional billing responsibilities

IHS, ASC, and institutional billing responsibilities: IHS facilities may bill for Part B services only when authorized; ASC suppliers must be enrolled and follow billing rules for DME/prosthetics/ambulance/lab items. ASC payment and IOL payment rules apply; note IOL investigator reporting requirements for investigational intraocular lenses. Hospital outpatient billing and contractor determinations apply for miscellaneous HCPCS codes.

IHS facilities billing for Part B services; ASC certification and billing
IOL payment in ASCs; Investigational IOL investigator reporting requirement
Contractor determination for miscellaneous HCPCS codes; hospital outpatient billing rules

Documentation Required

Confirm coverage of personnel and document responsibility under arrangements

Non-covered personnel and provider responsibility under arrangements: Providers are responsible for services furnished under arrangements; non-covered personnel services should not be billed. Maintain documentation of contractual arrangements, supervising physician/NPP involvement, and assignment requirements when applicable.

Non-covered personnel services; provider responsibility for services under arrangements
Assignment requirement and maintain attending physician orders

Documentation Required

Billing hygiene: orders, codes, screening rules, and credential documentation

Miscellaneous rules and billing hygiene: Use correct diagnostic and replacement codes, avoid noncovered G-codes used to generate denials, follow written order requirements for specific screening tests (barium enema, FOBT), document glaucoma and Pap smear frequency and childbearing status as required, and ensure MFT/MHC credentialing documentation is retained.

Written order requirement for screening barium enema and FOBT
Use of diagnostic codes and replacement codes; avoid noncovered G-codes to generate denials
Glaucoma screening billing requirements; Pap smear frequency and childbearing documentation
MFT/MHC credentialing documentation

Colonoscopy - High Risk: Screening colonoscopy for high-risk (G0105): covered when performed by MD/DO at frequency once every 24 months (>=23 months) for beneficiaries at high risk; follow-on colonoscopy after positive stool-based test is covered regardless of frequency limits (effective 2023-01-01).>=23 months (high risk)

High-risk ICD lists provided; follow-on colonoscopy exempt from frequency limits.

Colonoscopy - Not High Risk: Screening colonoscopy for not-high-risk (G0121): covered once every 10 years (>=119 months); follow-on colonoscopy after positive non-invasive stool-based test covered regardless of frequency limits (effective 2023-01-01).>=119 months

Barium Enema: Screening barium enema (G0106/G0120) covered as alternative to sigmoidoscopy or colonoscopy; frequency mirrors corresponding procedures (47 months for age 45+, 23 months for high-risk); require written order and double contrast unless patient intolerant.>=47 or >=23 months depending

Minimum age reduced to 45 effective 2023-01-01.

High Risk Determination: High risk defined by close relative with colorectal cancer or adenomatous polyp; familial adenomatous polyposis; hereditary nonpolyposis colorectal cancer; personal history of colorectal cancer or adenomatous polyps; inflammatory bowel disease (Crohn's, ulcerative colitis); lists of ICD-10 codes are provided for determinations.

Frequency counting starts month after previous test month.

Mammography and Pap Smear Screening Frequency Rules and Exceptions

Mammography screening frequency rules and Pap smear screening frequency + childbearing/high-risk exceptions with thresholds (11 months / 23 months / 119 months as applicable).

Mammography: Screening mammography: baseline for ages 35-39, no payment under 35; for women over 39 pay after at least 11 full months have passed since month of last covered mammography; deductible waived for annual mammography for women over 39.>=11 months after prior screening

Billing per Claims Processing Manual Chapter 18.

Pap Smear: Screening Pap smears: for high risk or childbearing-age women with prior abnormal Pap, covered not more frequently than once every 11 months; for others, biennial coverage (>=23 months) after July 1, 2001; documentation required for childbearing/high-risk exceptions.high-risk/childbearing >=11 months; routine >=23 months

High-risk factors include early sexual activity, multiple partners, STD/HIV history, fewer than three negatives in prior 7 years, DES exposure.

Annual Wellness Visit (AWV) - Eligibility, HRA, and SDOH (G0136) Billing Guidance

AWV/PPPS eligibility and required elements including HRA requirements and SDOH optional element (G0136) billing modifier -33 and date-of-service guidance.

AWV eligibility: AWV providing PPPS covered when performed by a health professional for eligible beneficiary who is >12 months after first Part B effective date and has not received IPPE or AWV within past 12 months; coinsurance and deductible waived.not within 12 months of IPPE/AWV

Health professional types defined (physician, PA, NP, CNS, certain others).

Required elements: First AWV includes review/administration of HRA, establishment of medical/family history, list of providers, measurement of height/weight/BMI/waist/BP, detection of cognitive impairment, depression risk screening, review functional ability and safety, establishment/update of written screening schedule and list of risk factors and personalized health advice/referrals.HRA <=20 minutes

HRA must collect specified self-reported info and be culturally/linguistically appropriate.

SDOH as optional AWV element: SDOH Risk Assessment (G0136) optional element for AWV starting CY2024: standardized evidence-based tool, separately payable with no cost sharing when furnished with AWV; report G0136 with modifier -33 on same claim and date as G0438/G0439; if elements furnished over multiple days, report date of service when entirety of AWV completed and document multi-day services.report G0136 with -33 on same DOS as AWV

G0136 without -33 processed with E/M or behavioral health visit and patient cost-sharing applies.

Immunization Coverage and In-home Vaccine Payment Criteria

Immunization coverage criteria cluster with intervals and in-home vaccine payment criteria consolidated.

Pneumococcal: PCV20 or PCV15 recommended for adults >=65 or 19-64 with risk factors; when PCV15 used follow with PPSV23; interval PCV15->PPSV23 >=1 year (8 weeks for immunocompromised/cochlear implant/CSF leak); PCV after PPSV23 >=1 year; follow CMS guidance for special series and relying on patient verbal history.PCV15->PPSV23 >=1 year; 8 weeks immunocompromised

Effective July 1, 2021 and Oct 19, 2022 updates.

Hepatitis B: Effective Jan 1, 2025: Part B covers hepatitis B vaccine and administration for beneficiaries at high or intermediate risk with enumerated groups; exception for those with lab evidence of antibodies; ESRD administration separately payable.Effective 2025-01-01

High and intermediate risk groups listed.

Influenza vaccine and administration covered once per flu season when furnished in compliance with state law by eligible providers; no physician order required.once per season

Effective May 1, 1993.

COVID-19 vaccines and administration covered under Part B when furnished in compliance with state law by eligible providers; coverage effective Nov 2, 2020 and Dec 11, 2020 dates noted for pricing/payment guidance.effective Nov/Dec 2020

CMS provides pricing guidance on vaccine pricing site and OPPS Addendum B.

In-home additional payment: Additional Part B payment for in-home administration allowed if patient has difficulty leaving home or faces barriers; sole purpose visit; home not institution; furnisher documents clinical status or barriers; only one additional payment per patient per home visit even if multiple vaccines administered.sole purpose; document barriers

Examples of barriers include supportive device needs, susceptibility, disability, socioeconomic/geographic/communication barriers, hard-to-reach populations.

Delayed certifications acceptable with justification up to 30 days without justification and longer with documentation.

Progress report timing: Progress reports required at least once every 10 treatment days; if not written before end of reporting period, write within 7 calendar days after end of reporting period; discharge note required for each episode covering from last progress report to discharge.>= once every 10 treatment days; delayed within 7 days

Treatment notes may serve as progress reports when required info included.

Treatment note content: Treatment notes required for every treatment day: date, specific interventions/modality provided and billed, total timed code treatment minutes and total treatment time, signature/professional ID of provider; record each timed service even if unbilled.timed minutes and total treatment time recorded

Billing must be consistent with timed minutes.

Documentation requirements: Evaluation/re-evaluation, certification/recertifications, progress reports, treatment notes, discharge notes, objective measures recommended; records must justify skilled nature, medical necessity, plan approvals and clinician active participation.progress reports and recertifications per above

Functional reporting (G-codes) applied 2013-2018 and removed for DOS >=2019.

Functional reporting historical note: Functional reporting G-codes and severity modifiers were required for dates of service 2013-01-01 through 2018-12-31; documentation guidance applied then but functional reporting requirements removed for DOS on/after 2019-01-01.2013-01-01 to 2018-12-31

Clinicians documented G-code and modifiers and rationale in record during that period.

SLP, PTA/OTA, Group Therapy, TPP, and Incident-to Therapy Billing & Supervision Rules

SLP, PTA/OTA, group therapy, therapist-in-private-practice (TPP), incident-to therapy billing distinctions and supervision rules.

SLP qualifications: Qualified SLP must meet requirements: master's or doctoral degree and be licensed or meet alternative pathways in states without licensing; effective Jan 1, 2015 updated qualifications applied.master's or doctoral + state licensure or alternative criteria

SLP assistants not recognized for Medicare coverage.

PTA/OTA roles: PTAs/OTAs may provide services under supervision but may not perform evaluations, make clinical judgments, develop/manage skilled maintenance programs, or take responsibility for service; supervising PT/OT bills for services; supervision levels vary by setting; in private practice direct supervision onsite required.onsite direct supervision in private practice

Aides not therapy services.

Group therapy billing: Group therapy (97150) payable when services provided simultaneously to two or more individuals by practitioner in constant attendance; only services of qualified therapist billed and paid; students' services not separately reimbursed.practitioner in constant attendance

PTP rules apply for private practice billing and space requirements.

TPP rules: Therapist in Private Practice (TPP) must be enrolled as private practitioner, have office/home practice space used exclusively, furnish services under direct supervision in office setting; direct supervision requires supervising therapist present in office suite at time of service.direct supervision onsite

Assignment/payment rules apply; therapists may bill when qualified.

Incident-to therapy distinctions: Therapy services have own benefit; services billed incident-to physician must meet therapy benefit standards; PTAs/OTAs may not be billed incident-to; qualified auxiliary personnel in incident-to need not have state licensure but must meet other qualifications; direct supervision required in office suite.direct supervision for incident-to

Physician must have initiated course and maintain active participation.

Sleep Disorder Clinic Diagnostic Testing Coverage Criteria and Codes

Sleep Disorder Clinic diagnostic testing coverage criteria: conditions covered (narcolepsy, sleep apnea, parasomnia, nocturnal penile tumescence), persuasive evidence requirement for additional sessions, and relevant codes (95828, 95805, 95807, 95810, 95822, 54250).

Eligibility and facility criteria: Diagnostic tests covered when clinic affiliated with hospital or under physician direction, patients referred by attending physicians with orders, need confirmed by medical evidence.physician referral and orders

Covered conditions and typical testing: Narcolepsy: usually confirmed by three sleep naps (95828, 95805); Sleep apnea: ordinarily single polysomnogram/EEG (95807, 95810, 95822); Parasomnia: polysomnography when seizure ruled out or history of violent/injurious episodes (95807/95810/95822); Nocturnal penile tumescence for impotence ordinarily two nights (54250). Additional sessions beyond typical require persuasive medical evidence.persuasive evidence for >typical sessions

Polysomnography for chronic insomnia not covered.

Not covered: Polysomnography for chronic insomnia not covered (not reasonable and necessary).

Beneficiary's home definition: Home includes dwelling, apartment, relative's home, home for aged, assisted living, or ICF/IID; institution meeting basic hospital or SNF requirements is NOT the beneficiary's home for DME purposes.

Delivery date rules apply (mail ship date etc.).

Miscellaneous codes: Contractors determine benefit category for miscellaneous DMEPOS codes (e.g., A9999, E1399) on a claim-by-claim basis to decide if item falls within DMEPOS categories and coverage/exclusions per §1862.claim-by-claim determination

Prosthetic Device Coverage, Replacement under BIPA, Prosthetic Lenses, Dentures Exclusion

Prosthetic device coverage rules including permanence test, replacement under BIPA (replacement allowed if change in physiology, irreparable device, or repair cost >60%), prosthetic lenses and cataract rules (one pair post IOL), and dentures exclusion with exceptions.

Prosthetic coverage general: Prosthetic devices covered when replace all or part of internal body organ or function of permanently inoperative/malfunctioning internal organ, furnished on physician's order; permanence test satisfied when condition is long and indefinite per medical record/attending physician.physician order; permanence via record

Accessories/supplies may be covered per NCD guidelines.

BIPA replacement rules: Under BIPA replacement payable without regard to continuous use/useful lifetime if physician determines replacement necessary due to change in physiology, irreparable device, or repair cost >60%; effective for items replaced on/after 2001-04-01.one of three reasons (physiologic change/irreparable/repair>60%)

Prosthetic lenses and cataract rules: Prosthetic lenses replacing eye lens covered when reasonable/necessary; one pair of conventional eyeglasses or contacts covered after each cataract surgery with IOL; IOL payment bundled into ASC facility payment for services on/after 1990-03-12.one pair post IOL

UV absorbing lenses may be covered if medically necessary; cataract sunglasses not covered.

Dentures exclusion and exceptions: Dentures excluded; exception when denture or portion integral part of a covered prosthesis (e.g., obturator) then covered as part of prosthesis.integral part exception

Contractor discretion claim-by-claim.

Lymphedema Compression Treatment Items Coverage and Frequency Rules

Lymphedema compression treatment items coverage criteria effective 2024-01-01, supplier enrollment as DMEPOS, covered item categories, custom vs standard definitions, replacement frequency rules (daytime 3 units/6 months, nighttime 2 units/2 years), and bandaging supplies discretion.

Eligibility and supplier: Coverage effective 2024-01-01 for beneficiaries with any diagnosis of lymphedema; items must be prescribed by physician/PA/NP/CNS as authorized under State law; items furnished by enrolled DMEPOS supplier; PTs and others furnishing bandaging must be enrolled as DMEPOS suppliers to be paid.effective 2024-01-01; supplier enrollment required

Coverage limited to lymphedema diagnoses only.

Covered item categories: Covered categories: standard daytime gradient compression garments; custom daytime gradient garments; nighttime gradient garments; gradient compression wraps with adjustable straps; accessories necessary for effective use; compression bandaging supplies; other items determined by CMS.

Custom fitted gradient garment defined precisely.

Replacement frequency rules: Replacements allowed if lost/stolen/irreparably damaged or patient medical condition changes; frequency limits: three units daytime garments or wraps per affected extremity once every 6 months; two nighttime garments per affected extremity once every 2 years; no set frequency for compression bandaging supplies (DME MAC discretion).daytime 3 units/6 months; nighttime 2 units/2 years

Bandaging supplies frequency discretionary by DME MAC.

Physician must notify patient of infusion options and coordinate with DME supplier.

Home infusion drug definition: Home infusion drug qualifies when parenteral IV or subcutaneous administered for >=15 minutes in home through pump that is DME; excludes insulin pump systems and self-administered drugs on exclusion list.>=15 minutes; parenteral IV/SC via DME pump

Drug must be billed under DME benefit no more than 30 days prior to home infusion visit.

Payment categories and single bundled payment: Home infusion drugs assigned to payment categories 1-3 by J-code; a single bundled payment made per infusion drug administration calendar day per payment category covering professional services, training/education, remote monitoring when professional services provided in home that day; claim requires G-code line-item with time in 15-min increments.single bundled payment per calendar day; 15-minute increment reporting

Category 1: certain IV therapy non-chemo; Category 2: subcutaneous infusions; Category 3: IV chemo and highly complex drugs.

First vs subsequent visit rules: Higher first-visit payment to initiate therapy; to bill first-visit payment again after discharge require >60 day gap with no G-code billed and discharge indicated; first visit may be billed on day 61.>60 day re-initiation gap

Medical review triggers: Payments may be subject to medical review for beneficiary eligibility, plan of care requirements, and medical necessity determinations.

Drug Coverage Criteria: Compendia, Off-Label Oncology, Self-Administration Exclusion, MAC Duties

Drug coverage criteria: compendia inclusion requirement, off-label/anti-cancer regimen coverage rules (compendia and peer-reviewed literature support), 'usually self-administered' exclusion (>50% threshold), MAC responsibilities to publish exclusion lists and provide 45-day notice before denying coverage.

Compendia inclusion: Payment may be made only where drug/biological is included or approved for inclusion in USP-NF, USP-DI, or ADA Guide to Dental Therapeutics; inclusion necessary but not sufficient; combination drugs included if combination or all therapeutic ingredients included.

Contractors may require compendia documentation.

Off-label oncology coverage: Off-label uses in anti-cancer regimens may be covered if supported by listed compendia (AHFS-DI, NCCN, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs) with compendia criteria (e.g., NCCN Cat 1/2A) or by peer-reviewed literature meeting quality/relevance standards; contractors may request supporting documentation.compendia categories or peer-reviewed literature criteria

CMS maintains process to amend compendia list via public requests.

Usually self-administered exclusion: 'Usually' means >50% of Medicare beneficiaries self-administer the drug for that indication; A/B MACs must determine per drug and indication, compute weighted average across indications; presumptions (IV/IM not usually self-administered; SC presumed self-administered) and evidentiary criteria (peer-reviewed literature, practice guidelines) apply.>50% threshold

MACs must publish process and list of excluded injectable drugs with data and rationale and provide 45-day notice prior to denial.

not entered during emergency/urgent care; retained for 2-year opt-out period

Private contract must state effective and expiration dates of 2-year period.

Emergency/urgent exceptions and GJ modifier: Exception: opt-out physician may treat beneficiary without private contract for emergency/urgent care; urgent defined as within 12 hours to avoid likely onset of emergency medical condition; physician must submit claim to Medicare with GJ modifier to indicate emergency/urgent services by opt-out provider; may collect no more than limiting charge or deductible/coinsurance per assignment rules; absence of GJ causes denial so beneficiary can appeal.urgent <=12 hours; use GJ modifier

Use of GJ ensures proper handling; additional modifiers like 54 may apply per example.

Contractor actions on suspected failure to maintain opt-out: Medicare contractor must send development letter describing suspected failure and request explanation/documentation within 45 days; hold claims in suspense; if no adequate response, deem opt-out nullified effective 46 days after notice; private contracts voided, claims must be submitted, limiting charge applies; remittance codes and MSN messages used (CARC 27/PR/MA47 and MA47 N771; MSN #21.20/#21.19).45-day response window; effective 46 days after notice

Good faith efforts may mitigate; contractor must maintain opt-out provider file and notify NSC and Medicare Advantage plans.

Consequences, cancellation, early termination: If fail to properly opt-out/private contract, attempt nullified, contracts void, must submit claims, subject to limiting charge; opt-out may be cancelled by notice 30 days before end of 2-year period; early termination within 90 days allowed with refunds and notifications and reinstatement as if no opt-out upon proper termination.90-day early termination window; refunds excess payments

Specific appeals are initial determinations under 42 CFR 498.3(b) and 405.924.

mutually exclusive depending on date

X-ray and devices: X-ray not required to demonstrate subluxation for DOS on or after Jan 1, 2000 but may be used for documentation; no coverage/payment for x-rays or other diagnostic/therapeutic services ordered/furnished by chiropractor; manual hand-held devices allowed but not separately payable.x-ray proximity rule (12 months/3 months) applies for documentation

Maintenance therapy exclusion: Maintenance therapy (care to prevent disease, promote health, maintain or prevent deterioration) is not medically reasonable/necessary and not payable; chiropractor must place AT modifier on claim when providing active/corrective treatment; absence of AT considered maintenance and denied.AT modifier for active/corrective treatment

ABN use and GA/GZ modifiers guidance if ABN given.

Contraindications to dynamic thrust: Relative contraindications include articular hypermobility, severe demineralization, benign bone tumors, bleeding disorders, radiculopathy with progressive neuro signs. Absolute contraindications include acute inflammatory arthropathies, acute fractures/dislocations, unstable os odontoideum, malignancies involving vertebral column, infection of vertebral bones/joints, signs of myelopathy/cauda equina, vertebrobasilar insufficiency for cervical manipulations, significant nearby arterial aneurysm.absolute vs relative categories

Dynamic thrust absolutely contraindicated near proposed manipulation site in listed conditions.

Documentation for chiropractic visits: the initial visit record must include history (presenting symptoms/mechanism and prior interventions), a description of the present illness tied to the subluxation level, a focused physical examination of the musculoskeletal/neurologic system, a diagnosis naming subluxation and specifying level, and a treatment plan with recommended duration, frequency, specific goals and objective measures plus the date of initial treatment. For subsequent visits document review of the chief complaint/changes since prior visit, targeted exam of the involved spinal area and assessment of change/progress, and the specific treatment given that day. Acceptable formats to report subluxation location include exact vertebrae (e.g., C5) or descriptive regional descriptors (e.g., occipito‑atlantal, lumbosacral, sacroiliac) and accepted terms (e.g., misalignment, rotation, hypomotility). For x‑ray support, x‑rays are considered reasonably proximate if taken no more than 12 months prior to, or 3 months after initiation of treatment; older films may be acceptable for documented chronic cases.

inextricably linked/integral to clinical success

Contractors have flexibility to determine on claim-by-claim basis.

Covered ancillary services: Ancillary services/supplies furnished incident to covered dental services (e.g., anesthesia, diagnostic x-rays, use of OR) are not excluded and Medicare may pay under applicable parts.incident-to rules apply

Contractor discretion: MACs determine on claim-by-claim whether circumstances fit statutory preclusion or exceptions; payment may be made for covered dental services furnished by physician, dentist, or nonphysician practitioner consistent with state law and scope of practice.claim-by-claim contractor discretion

Foot Care Coverage/Exclusion, Class A/B/C Presumption, Mycotic Nail Documentation Requirements

Foot care coverage/exclusion criteria: routine foot care exclusions, conditions where routine procedures may be covered (systemic disease with documented complications) with Class A/B/C findings and presumption rules, and documentation requirements for mycotic nails (requirements for ambulatory vs nonambulatory).

Routine foot care exclusions: Routine foot care (cutting/removal of corns/calluses, nail trimming/debriding, hygienic/preventive maintenance) and supportive devices for feet generally not covered; flat foot treatment excluded except as integral to other covered care.

When routine care may be covered: Routine procedures may be covered when necessary and integral to otherwise covered services (e.g., diagnosis/treatment of ulcers, wounds, infections) or when systemic disease (e.g., diabetes, peripheral vascular disease, neuropathy) causes severe circulatory compromise or diminished sensation; specific Class A/B/C findings support coverage presumption.Class A/B/C findings sufficiency

Contractor may deem active care met if MD seen within 6 months or MD concurrence provided.

Class findings presumption: Presumption of coverage when physician documents: 1) one Class A (nontraumatic foot amputation) OR 2) two Class B findings (e.g., absent posterior tibial pulse; advanced trophic changes (three required) ; absent dorsalis pedis pulse) OR 3) one Class B and two Class C findings (claudication, temperature changes, edema, paresthesias, burning).one A OR two B OR one B + two C

Mycotic nails documentation: For ambulatory patients: must document clinical evidence of mycosis AND marked limitation of ambulation, pain, or secondary infection due to thickening/dystrophy. For nonambulatory: document mycosis AND pain or secondary infection. Documentation subject to A/B MAC verification.documented mycosis + functional/pain/infection criteria

Informational historical transmittal index entry listing transmittals R01BP through R72BP with issue dates, subjects, implementation dates, and CR numbers (chapter transmittal history).