Supplementary Medical Insurance (smi) Benefits

Basis and scope.

This section outlines the statutory basis and scope of Medicare Part B benefits, including payment conditions, coverage limitations, and beneficiary responsibilities.

Medical and other health services: Included services.

Subject to the conditions and limitations specified in this subpart, “medical and other health services” includes the following services:

Included services.

This section defines the specific services covered as CORF services, including physical, occupational, speech, and respiratory therapies, as well as nursing and other support services.

Excluded services.

This section specifies services that are not covered as CORF services, including those that would not be covered as inpatient hospital services or are not reasonable and necessary.

Requirements for coverage of CORF services.

This section details the requirements for CORF service coverage, including physician referral, medical history, plan of treatment, and specific billing modifiers for therapy assistants.

Requirements for coverage of partial hospitalization services by CMHCs.

This section outlines the requirements for Medicare Part B coverage of partial hospitalization services provided by Community Mental Health Centers, including physician supervision and treatment plans.

Requirements for coverage of intensive outpatient services in CMHCs.

This section outlines the requirements for Medicare Part B coverage of intensive outpatient services provided by Community Mental Health Centers, including physician supervision and treatment plans.

Medical and other health services: Basic conditions and limitations.

This section establishes the basic conditions for Medicare Part B coverage of medical and other health services, including entitlement periods, provider requirements, and physician certification.

Definitions.

Provides definitions for terms such as chronic renal insufficiency, diabetes, episode of care, and medical nutrition therapy services for Medicare Part B coverage.

Medical nutrition therapy.

Outlines conditions for Medicare Part B coverage of medical nutrition therapy, including referral requirements, coverage limitations, and exceptions for medical necessity.

Provider qualifications.

Specifies the educational, supervised practice, and licensure requirements for registered dietitians or nutrition professionals to provide Medicare-covered medical nutrition therapy.

Special requirements for services furnished outside the United States.

Sets conditions for Medicare Part B payment for physician and ambulance services provided outside the United States when connected to covered inpatient hospital services.

Definitions.

Provides definitions for terms related to outpatient diabetes self-management training, including approved entity, deemed entity, and rural area designations.

Outpatient diabetes self-management training.

Details the coverage conditions, plan of care requirements, training session limits, and provider accreditation standards for outpatient diabetes self-management training.

CMS process for approving national accreditation organizations.

This provision details the application, review, and approval process for national accreditation organizations seeking CMS recognition to accredit entities for diabetes self-management training.

Requirements for approved accreditation organizations.

This provision outlines the ongoing responsibilities, reporting requirements, and CMS oversight mechanisms for organizations approved to accredit diabetes self-management training entities.

Quality standards for deemed entities.

This provision establishes the quality standards for entities providing diabetes self-management training, including requirements for organizational structure, staffing, training content, and quality improvement programs.

Requirements for entities.

This provision outlines the administrative requirements for entities to be deemed or approved by CMS to furnish diabetes self-management training, including accreditation and evaluation procedures.

Diabetes outcome measurements.

This provision mandates that approved entities collect and record specific patient assessment and clinical outcome data for beneficiaries receiving diabetes self-management training.

Annual wellness visits providing Personalized Prevention Plan Services: Conditions for and limitations on coverage.

This provision defines the requirements, eligibility criteria, and coverage limitations for Medicare Part B annual wellness visits and personalized prevention plan services.

To whom payment is made.

This provision specifies the entities, including providers, suppliers, and individuals, to whom Medicare Part B payments are assigned for various covered health services.

Amounts of payment.

This provision establishes the Medicare Part B payment methodologies and amounts for various services, including home health, durable medical equipment, renal dialysis, preventive services, and drugs.

Outpatient mental health treatment limitation.

This provision establishes the payment limitations and reimbursement formulas for outpatient mental health services provided under Medicare Part B.

Initial preventive physical examination: Conditions for and limitations on coverage.

This provision defines the scope, requirements, and clinical components of the Medicare-covered initial preventive physical examination.

Part B annual deductible.

This provision outlines the rules, exceptions, and calculation methods for the Medicare Part B annual deductible applied to patient services.

Part B blood deductible.

This provision defines the Part B blood deductible, beneficiary responsibility for the first three units of blood, and rules for hospital or supplier charges.

Payment for services furnished to kidney donors.

This provision establishes that there are no deductible or coinsurance requirements for services provided to individuals donating a kidney for transplant surgery.

Payment for rural health clinic services and ambulatory surgical center services: Conditions.

This provision outlines the conditions for Medicare Part B payment for services furnished by rural health clinics, federally qualified health centers, and ambulatory surgical centers.

Cardiovascular disease screening tests.

This provision defines cardiovascular screening blood tests and establishes conditions for Medicare Part B coverage, including frequency limitations.

Payment for home health services, for medical and other health services furnished by a provider or an approved ESRD facility, and for comprehensive outpatient rehabilitation fac...

This provision specifies the conditions for Medicare Part B payment for home health, provider-based medical services, and comprehensive outpatient rehabilitation facility services.

Payment for partial hospitalization services in CMHCs: Conditions.

This provision establishes the conditions for Medicare Part B payment for partial hospitalization services furnished in community mental health centers.

Payment for intensive outpatient services in CMHCs: Conditions.

This provision establishes the conditions for Medicare Part B payment for intensive outpatient services furnished in community mental health centers.

Alien absent from the United States.

This provision specifies that Medicare Part B benefits are not payable for services furnished to non-citizens who have been outside the United States for six consecutive months.

Diabetes screening tests.

This provision defines diabetes screening tests, eligible risk factors, and coverage conditions for Medicare Part B.

Ultrasound screening for abdominal aortic aneurysms: Condition for and limitation on coverage.

This provision defines eligible beneficiaries, coverage conditions, and limitations for ultrasound screening for abdominal aortic aneurysms.

Definitions.

As used in this part—

Physicians' services.

This provision defines the scope of Medicare Part B coverage for physicians' services, including requirements for authorized practitioners and the process for requesting prior determinations of medical necessity.

Limitations on services of a chiropractor.

This provision establishes the educational and licensure qualifications for chiropractors and limits Medicare Part B coverage to manual spinal manipulation for specific neuromusculoskeletal conditions.

Limitations on services of an optometrist.

Medicare Part B pays for the services of a doctor of optometry, which he or she is legally authorized to perform in the State in which he or she performs them, if the services are among those described in section 1861(s) of the Act and §...

Screening for glaucoma: Conditions for and limitations on coverage.

This provision defines eligible beneficiaries and the conditions for Medicare Part B coverage of glaucoma screening examinations, including supervision requirements for optometrists and ophthalmologists.

Limitations on services of a doctor of dental surgery or dental medicine.

This provision specifies that Medicare Part B covers services furnished by a dentist if those services would be covered as physicians' services when performed by a doctor of medicine or osteopathy.

Limitations on services of a podiatrist.

This provision specifies that Medicare Part B covers services furnished by a podiatrist if those services would be covered as physicians' services when performed by a doctor of medicine or osteopathy.

Services and supplies incident to a physician's professional services: Conditions.

This provision establishes the conditions for Medicare Part B payment for services and supplies furnished incident to a physician's or practitioner's professional services in a noninstitutional setting.

Therapeutic outpatient hospital or CAH services and supplies incident to a physician's or nonphysician practitioner's service: Conditions.

This provision outlines the conditions for Medicare Part B payment for therapeutic outpatient hospital services, including supervision requirements and specific rules for partial hospitalization.

Hospital or CAH diagnostic services furnished to outpatients: Conditions.

This provision specifies the conditions under which Medicare Part B pays for hospital diagnostic services furnished to outpatients, including supervision and arrangement requirements.

Limitations on drugs and biologicals.

Medicare part B does not pay for the following:

Scope of benefits.

This provision defines the scope of the Supplementary Medical Insurance (SMI) program and outlines general limitations on payment for covered services.

Prescription drugs used in immunosuppressive therapy.

This provision specifies the coverage conditions and eligibility requirements for prescription drugs used in immunosuppressive therapy under Medicare Part B.

Bone mass measurement: Conditions for coverage and frequency standards.

This provision establishes the Medicare coverage conditions, frequency standards, and beneficiary eligibility criteria for medically necessary bone mass measurement procedures.

Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

This regulation establishes the requirements for ordering, supervising, and documenting diagnostic tests, including x-rays and laboratory services, to ensure they are reasonable and necessary for Medicare coverage.

Independent diagnostic testing facility.

This provision establishes the operational, enrollment, and performance standards for independent diagnostic testing facilities (IDTFs) to qualify for Medicare reimbursement.

Mammography services: Conditions for and limitations on coverage.

This provision outlines Medicare Part B coverage conditions, limitations, and FDA certification requirements for diagnostic and screening mammography services.

X-ray therapy and other radiation therapy services: Scope.

This provision defines the scope of Medicare Part B coverage for X-ray, radium, and radioactive isotope therapy services, including technician services.

Medical supplies, appliances, and devices: Scope.

This provision specifies the medical supplies, prosthetics, braces, and lymphedema treatment items covered under Medicare Part B.

Colorectal cancer screening tests: Conditions for and limitations on coverage.

This provision details the conditions, frequency limitations, and coverage requirements for various colorectal cancer screening tests under Medicare Part B.

Durable medical equipment, prosthetics, orthotics and supplies (DMEPOS): Scope and conditions.

This provision establishes Medicare Part B coverage conditions for DMEPOS, including requirements for written orders, face-to-face encounters, and documentation for recurring refills.

Prostate cancer screening tests: Conditions for and limitations on coverage.

This provision outlines the Medicare Part B coverage conditions, provider eligibility, and frequency limitations for prostate cancer screening tests.

Coverage of ambulance services.

This provision establishes the Medicare Part B coverage criteria, medical necessity requirements, and documentation standards for ambulance transportation services.

Requirements for ambulance providers and suppliers.

Specifies vehicle, staffing, and billing requirements for ambulance services under Medicare Part B.

Limitations on coverage of certain services furnished to hospital outpatients.

Defines Medicare Part B payment limitations for services provided to hospital outpatients by entities other than the hospital.

Partial hospitalization services: Conditions and exclusions.

Outlines the conditions, coverage, and patient eligibility requirements for Medicare Part B partial hospitalization services.

Intensive outpatient services: Conditions and exclusions.

Outlines the conditions, coverage, and patient eligibility requirements for Medicare Part B intensive outpatient services.

Rural health clinic services: Scope and conditions.

Specifies the scope of Medicare Part B coverage for services furnished by rural health clinics.

Physician and other practitioner services furnished in or at the direction of an IHS or Indian tribal hospital or clinic: Scope and conditions.

Establishes Medicare Part B payment conditions for services provided in or at the direction of Indian Health Service or tribal hospitals and clinics.

Pulmonary rehabilitation program: Conditions for coverage.

This provision establishes the requirements for Medicare Part B coverage of pulmonary rehabilitation programs, including definitions, covered conditions, program components, staffing standards, and session limitations.

Kidney disease education services.

This provision outlines the conditions for Medicare Part B coverage of kidney disease patient education services, including beneficiary eligibility, qualified provider standards, content requirements, and session limitations.

Cardiac rehabilitation program and intensive cardiac rehabilitation program: Conditions of coverage.

This provision defines the requirements, staffing standards, and coverage conditions for cardiac and intensive cardiac rehabilitation programs in hospital outpatient settings.

Other applicable rules.

This provision provides cross-references to other regulatory parts governing specific services such as ESRD, rural health clinics, ambulatory surgery, and laboratory services.

Institutional dialysis services and supplies: Scope and conditions.

Medicare Part B pays for the following institutional dialysis services and supplies if they are furnished in approved ESRD facilities:

Home dialysis services, supplies, and equipment: Scope and conditions.

This provision outlines the scope of Medicare Part B coverage for home dialysis equipment, supplies, and support services for patients with ESRD or acute kidney injury.

Marriage and family therapist services.

This provision defines marriage and family therapist services, sets qualification standards, and prohibits billing for services provided to hospital inpatients.

Mental health counselor services.

This provision defines mental health counselor services, sets qualification standards, and prohibits billing for services provided to hospital inpatients.

Services related to kidney donations: Conditions.

This provision outlines the conditions under which Medicare Part B covers medical services furnished in connection with a kidney donation.

Screening pelvic examinations.

This provision outlines the Medicare Part B coverage conditions and frequency limitations for screening pelvic examinations performed by qualified practitioners.

Preventive vaccines.

This provision specifies the Medicare Part B coverage for the administration of pneumococcal, influenza, COVID-19, and Hepatitis B vaccines.

Additional services to HMO and CMP enrollees.

Services not usually covered under Medicare Part B may be covered as medical and other health services if they are furnished to an enrollee of an HMO or a CMP and the following conditions are met:

Outpatient occupational therapy services: Conditions.

This provision outlines the conditions for Medicare Part B coverage of outpatient occupational therapy services, including supervision requirements, billing modifiers for assistants, and annual medical review thresholds.

Outpatient physical therapy services: Conditions.

This provision outlines the conditions for Medicare Part B coverage of outpatient physical therapy services, including requirements for physician oversight, plans of treatment, supervision, billing modifiers for physical therapist assistants, and medical necessity thresholds.

Plan of treatment requirements for outpatient rehabilitation services.

This provision establishes the mandatory requirements for written plans of treatment for outpatient physical, occupational, and speech-language pathology services.

Outpatient speech-language pathology services: Conditions and exclusions.

This provision outlines the conditions for Medicare coverage and payment for outpatient speech-language pathology services.

Hepatitis B vaccine and blood clotting factors: Conditions.

Notwithstanding the exclusion from coverage of vaccines (see § 411.15 of this chapter) and self-administered drugs (see § 410.29), the following services are included as medical and other health services covered under § 410.10, subject t...

Additional preventive services.

This provision defines the criteria under which Medicare Part B covers additional preventive services based on national coverage determinations.

Emergency outpatient services furnished by a nonparticipating hospital and services furnished in a foreign country.

This provision provides a cross-reference to the conditions for payment of emergency services furnished by nonparticipating hospitals or in foreign countries.

Medicare coverage and payment of Opioid use disorder treatment services furnished by Opioid treatment programs.

This provision establishes the Medicare coverage, bundled payment methodology, and operational requirements for opioid treatment programs, including certification and accreditation standards.

Antigens: Scope and conditions.

Medicare Part B covers antigens furnished incident to a physician's professional services or supplied for a patient under a physician-developed treatment plan.

Services of a certified registered nurse anesthetist or an anesthesiologist's assistant: Basic rule and definitions.

This rule defines the qualifications, scope of practice, and documentation standards for certified registered nurse anesthetists and anesthesiologist's assistants under Medicare Part B.

Clinical psychologist services and services and supplies incident to clinical psychologist services.

This provision outlines the coverage, qualification, and consultation requirements for clinical psychologists billing Medicare Part B.

Registered dietitians' and nutrition professionals' services.

This rule specifies the coverage, limitations, and billing requirements for medical nutrition therapy and diabetes self-management services provided by registered dietitians.

Clinical social worker services.

This provision defines the qualifications, covered services, and billing prohibitions for clinical social workers under Medicare Part B.

Physician assistants' services.

This rule establishes the coverage conditions, qualification standards, and documentation requirements for physician assistant services under Medicare Part B.

Nurse practitioners' services.

This provision establishes the Medicare Part B coverage requirements, professional qualifications, collaborative practice standards, and medical record documentation rules for nurse practitioners.

Clinical nurse specialists' services.

This provision outlines the Medicare Part B coverage criteria, professional qualifications, collaborative practice requirements, and medical record documentation standards for clinical nurse specialists.

Certified nurse-midwives' services: Qualifications and conditions.

This provision specifies the Medicare Part B coverage, professional qualifications, and medical record documentation requirements for certified nurse-midwives.

Telehealth services.

This provision defines the requirements, eligible practitioners, originating sites, and payment conditions for Medicare Part B coverage of telehealth services.

Medicare Diabetes Prevention Program expanded model: Conditions of coverage.

This provision establishes the conditions of coverage, beneficiary eligibility, and operational requirements for the Medicare Diabetes Prevention Program, including delivery modalities and emergency policy flexibilities.

Applicable rules.

Home health services furnished under Medicare Part B are subject to the rules set forth in subpart E of part 409 of this chapter.