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<BODY><PRE>[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR410]

[Page 241-298]
 
                         TITLE 42--PUBLIC HEALTH
 
                             HUMAN SERVICES
 
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) <STRONG>BENEFITS</STRONG>

                      Subpart A--General Provisions

Sec.
410.1  Basis and <STRONG>scope</STRONG>.
410.2  Definitions.
410.3  <STRONG>Scope</STRONG> of <STRONG>benefits</STRONG>.
410.5  Other applicable rules.

              Subpart B--Medical and Other Health Services

410.10  Medical and other health services: Included services.
410.12  Medical and other health services: Basic conditions and 
          limitations.
410.14  Special requirements for services furnished outside the United 
          States.
410.20  Physicians' services.
410.21  Limitations on services of a chiropractor.
410.22  Limitations on services of an optometrist.
410.23  Screening for glaucoma: Conditions for and limitations on 
          coverage
410.24  Limitations on services of a doctor of dental surgery or dental 
          medicine.
410.25  Limitations on services of a podiatrist.
410.26  Services and supplies incident to a physician's professional 
          services: Conditions.
410.27  Outpatient hospital services and supplies incident to a 
          physician service: Conditions.
410.28  Hospital or CAH diagnostic services furnished to outpatients: 
          Conditions.
410.29  Limitations on drugs and biologicals.
410.30  Prescription drugs used in immunosuppressive therapy.
410.31  Bone mass measurement: Conditions for coverage and frequency 
          standards.
410.32  Diagnostic X-ray tests, diagnostic laboratory tests, and other 
          diagnostic tests: Conditions.
410.33  Independent diagnostic testing facility.
410.34  Mammography services: Conditions for and limitations on 
          coverage.
410.35  X-ray therapy and other radiation therapy services: <STRONG>Scope</STRONG>.
410.36  Medical supplies, appliances, and devices: <STRONG>Scope</STRONG>.
410.37  Colorectal cancer screening tests: Conditions for and 
          limitations on coverage.
410.38  Durable medical equipment: <STRONG>Scope</STRONG> and conditions.
410.39  Prostate cancer screening tests: Conditions for and limitations 
          on coverage.

[[Page 242]]

410.40  Coverage of ambulance services.
410.41  Requirements for ambulance suppliers.
410.42  Limitations on coverage of certain services furnished to 
          hospital outpatients.
410.43  Partial hospitalization services: Conditions and exclusions.
410.45  Rural health clinic services: <STRONG>Scope</STRONG> and conditions.
410.46   Physician and other practitioner services furnished in or at 
          the direction of an IHS or Indian tribal hospital or clinic: 
          <STRONG>Scope</STRONG> and conditions.
410.50  Institutional dialysis services and supplies: <STRONG>Scope</STRONG> and 
          conditions.
410.52  Home dialysis services, supplies, and equipment: <STRONG>Scope</STRONG> and 
          conditions.
410.55  Services related to kidney donations: Conditions.
410.56  Screening pelvic examinations.
410.57  Pneumococcal vaccine and flu vaccine.
410.58  Additional services to HMO and CMP enrollees.
410.59  Outpatient occupational therapy services: Conditions.
410.60  Outpatient physical therapy services: Conditions.
410.61  Plan of treatment requirements for outpatient rehabilitation 
          services.
410.62  Outpatient speech-language pathology services: Conditions and 
          exclusions.
410.63  Hepatitis B vaccine and blood clotting factors: Conditions..
410.66  Emergency outpatient services furnished by a nonparticipating 
          hospital and services furnished in Mexico or Canada.
410.68  Antigens: <STRONG>Scope</STRONG> and conditions.
410.69  Services of a certified registered nurse anesthetist or an 
          anesthesiologist's assistant: Basic rule and definitions.
410.71  Clinical psychologist services and services and supplies 
          incident to clinical psychologist services.
410.73  Clinical social worker services.
410.74  Physician assistants' services.
410.75  Nurse practitioners' services.
410.76  Clinical nurse specialists' services.
410.77  Certified nurse-midwives' services: Qualifications and 
          conditions.
410.78   Office and other outpatient visits, consultation, individual 
          psychotherapy and pharmacologic management via an interactive 
          telecommunications system.

                Subpart C--Home Health Services Under SMI

410.80  Applicable rules.

   Subpart D--Comprehensive Outpatient Rehabilitation Facility (CORF) 
                                Services

410.100  Included services.
410.102  Excluded services.
410.105  Requirements for coverage of CORF services.

  Subpart E--Community Mental Health Centers (CMHCs) Providing Partial 
                        Hospitalization Services

410.110  Requirements for coverage of partial hospitalization services 
          by CMHCs.

Subpart F [Reserved]

                  Subpart G--Medical Nutrition Therapy

410.130  Definitions.
410.132  Medical nutrition therapy.
410.134  Provider qualifications.

  Subpart H--Outpatient Diabetes Self-Management Training and Diabetes 
                          Outcome Measurements

410.140  Definitions.
410.141  Outpatient diabetes self-management training.
410.142  CMS process for approving national accreditation organizations.
410.143  Requirements for approved accreditation organizations.
410.144  Quality standards for deemed entities.
410.145  Requirements for entities.
410.146  Diabetes outcome measurements.

                   Subpart I--Payment of SMI <STRONG>Benefits</STRONG>

410.150  To whom payment is made.
410.152  Amounts of payment.
410.155  Outpatient mental health treatment limitation.
410.160  Part B annual deductible.
410.161  Part B blood deductible.
410.163  Payment for services furnished to kidney donors.
410.165  Payment for rural health clinic services and ambulatory 
          surgical center services: Conditions.
410.170  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 facility 
          (CORF) services: Conditions.
410.172  Payment for partial hospitalization services in CMHCs: 
          Conditions.
410.175  Alien absent from the United States.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395hh).

    Source: 51 FR 41339, Nov. 14, 1986, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 410 appear at 62 FR 
46037, Aug. 29, 1997.

[[Page 243]]

                      Subpart A--General Provisions

Sec. 410.1  Basis and <STRONG>scope</STRONG>.

    (a) Statutory basis. This part is based on the indicated provisions 
of the following sections of the Act:
    (1) Section 1832--<STRONG>Scope</STRONG> of <STRONG>benefits</STRONG> furnished under the Medicare 
Part B supplementary medical insurance (SMI) program.
    (2) Section 1833 through 1835 and 1862--Amounts of payment for SMI 
services, the conditions for payment, and the exclusions from coverage.
    (3) Section 1861(qq)--Definition of the kinds of services that may 
be covered.
    (4) Section 1865(b)--Permission for CMS to approve and recognize a 
national accreditation organization for the purpose of deeming entities 
accredited by the organization to meet program requirements.
    (5) Section 1881--Medicare coverage for end-stage renal disease 
beneficiaries.
    (b) <STRONG>Scope</STRONG> of part. This part sets forth the <STRONG>benefits</STRONG> available under 
Medicare Part B, the conditions for payment and the limitations on 
services, the percentage of incurred expenses that Medicare Part B pays, 
and the deductible and copayment amounts for which the beneficiary is 
responsible. (Exclusions applicable to these services are set forth in 
subpart C of part 405 of this chapter. General conditions for Medicare 
payment are set forth in part 424 of this chapter.)

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 55 
FR 53521, Dec. 31, 1990; 59 FR 63462, Dec. 8, 1994; 63 FR 58905, Nov. 2, 
1998; 65 FR 83148, Dec. 29, 2000]

Sec. 410.2  Definitions.

    As used in this part--
    Community mental health center (CMHC) means an entity that--
    (1) Provides outpatient services, including specialized outpatient 
services for children, the elderly, individuals who are chronically 
mentally ill, and residents of its mental health service area who have 
been discharged from inpatient treatment at a mental health facility;
    (2) Provides 24-hour-a-day emergency care services;
    (3) Provides day treatment or other partial hospitalization 
services, or psychosocial rehabilitation services;
    (4) Provides screening for patients being considered for admission 
to State mental health facilities to determine the appropriateness of 
this admission; and
    (5) Meets applicable licensing or certification requirements for 
CMHCs in the State in which it is located.
    Encounter means a direct personal contact between a patient and a 
physician, or other person who is authorized by State licensure law and, 
if applicable, by hospital or CAH staff bylaws, to order or furnish 
hospital services for diagnosis or treatment of the patient.
    Nominal charge provider means a provider that furnishes services 
free of charge or at a nominal charge, and is either a public provider 
or another provider that (1) demonstrates to CMS's satisfaction that a 
significant portion of its patients are low-income; and (2) requests 
that payment for its services be determined accordingly.
    Outpatient means a person who has not been admitted as an inpatient 
but who is registered on the hospital or CAH records as an outpatient 
and receives services (rather than supplies alone) directly from the 
hospital or CAH.
    Partial hospitalization services means a distinct and organized 
intensive ambulatory treatment program that offers less than 24-hour 
daily care and furnishes the services described in Sec. 410.43.
    Participating refers to a hospital, CAH, SNF, HHA, CORF, or hospice 
that has in effect an agreement to participate in Medicare; or a clinic, 
rehabilitation agency, or public health agency that has a provider 
agreement to participate in Medicare but only for purposes of providing 
outpatient physical therapy, occupational therapy, or speech pathology 
services; or a CMHC that has in effect a similar agreement but only for 
purposes of providing partial hospitalization services, and 
nonparticipating refers to a hospital, CAH,

[[Page 244]]

SNF, HHA, CORF, hospice, clinic, rehabilitation agency, public health 
agency, or CMHC that does not have in effect a provider agreement to 
participate in Medicare.

[59 FR 6577, Feb. 11, 1994, as amended at 62 FR 46025, Aug. 29, 1997; 65 
FR 18536, Apr. 7, 2000]

Sec. 410.3  <STRONG>Scope</STRONG> of <STRONG>benefits</STRONG>.

    (a) Covered services. The SMI program helps pay for the following:
    (1) Medical and other health services such as physicians' services, 
outpatient services furnished by a hospital or a CAH, diagnostic tests, 
outpatient physical therapy and speech pathology services, rural health 
clinic services, Federally qualified health center services, IHS, Indian 
tribe, or tribal organization facility services, and outpatient renal 
dialysis services.
    (2) Services furnished by ambulatory surgical centers (ASCs), home 
health agencies (HHAs), comprehensive outpatient rehabilitation 
facilities (CORFs), and partial hospitalization services provided by 
community mental health centers (CMHCs).
    (3) Other medicial services, equipment, and supplies that are not 
covered under Medicare Part A hospital insurance.
    (b) Limitations on amount of payment. (1) Medicare Part B does not 
pay the full reasonable costs or charges for all covered services. The 
beneficiary is responsible for an annual deductible and a blood 
deductible and, after the annual deductible has been satisfied, for 
coinsurance amounts specified for most of the services.
    (2) Specific rules on payment are set forth in subpart E of this 
part.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 24981, June 12, 1992; 
58 FR 30668, May 26, 1993; 59 FR 6577, Feb. 11, 1994; 66 FR 55328, Nov. 
1, 2001]

Sec. 410.5  Other applicable rules.

    The following other rules of this chapter set forth additional 
policies and procedures applicable to four of the kinds of services 
covered under the SMI program:
    (a) Part 405, subpart U: End-Stage Renal Disease services.
    (b) Part 405, Subpart X: Rural Health Clinic and Federally Qualified 
Health Center services.
    (c) Part 416: Ambulatory Surgical Center services.
    (d) Part 493: Laboratory Services.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 7134, Feb. 28, 1992; 57 
FR 24981, June 12, 1992]

              Subpart B--Medical and Other Health Services

Sec. 410.10  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:
    (a) Physicians' services.
    (b) Services and supplies furnished incident to a physician's 
professional services, of kinds that are commonly furnished in 
physicians' offices and are commonly either furnished without charge or 
included in the physicians' bills.
    (c) Services and supplies, including partial hospitalization 
services, that are incident to physician services and are furnished to 
outpatients by or under arrangements made by a hospital or a CAH.
    (d) Diagnostic services furnished to outpatients by or under 
arrangements made by a hospital or a CAH if the services are services 
that the hospital or CAH ordinarily furnishes to its outpatients for 
diagnostic study.
    (e) Diagnostic laboratory and X-ray tests (including diagnostic 
mammography that meets the conditions for coverage specified in 
Sec. 410.34(b) of this subpart) and other diagnostic tests.
    (f) X-ray therapy and other radiation therapy services.
    (g) Medical supplies, appliances, and devices.
    (h) Durable medical equipment.
    (i) Ambulance services.
    (j) Rural health clinic services.
    (k) Home dialysis supplies and equipment; on or after July 1, 1991, 
epoetin (EPO) for home dialysis patients, and, on or after January 1, 
1994, for dialysis patients, competent to use the drug; self-care home 
dialysis support services; and institutional dialysis services and 
supplies.

[[Page 245]]

    (l) Pneumococcal vaccinations.
    (m) Outpatient physical therapy and speech pathology services.
    (n) Cardiac pacemakers and pacemaker leads.
    (o) Additional services furnished to enrollees of HMOs or CMPs, as 
described in Sec. 410.58.
    (p) Hepatitis B vaccine.
    (q) Blood clotting factors for hemophilia patients competent to use 
these factors without medical or other supervision.
    (r) Screening mammography services.
    (s) Federally qualified health center services.
    (t) Services of a certified registered nurse anesthetist or an 
anesthesiologist's assistant.
    (u) Prescription drugs used in immunosuppressive therapy.
    (v) Clinical psychologist services and services and supplies 
furnished as an incident to the services of a clinical psychologist, as 
provided in Sec. 410.71.
    (w) Clinical social worker services, as provided in Sec. 410.73.
    (x) Services of physicians and other practitioners furnished in or 
at the direction of an IHS or Indian tribal hospital or clinic.

[51 FR 41339, Nov. 14, 1986, as amended at 52 FR 27765, July 23, 1987; 
55 FR 22790, June 4, 1990; 55 FR 53522, Dec. 31, 1990; 56 FR 8841, Mar. 
1, 1991; 56 FR 43709, Sept. 4, 1991; 57 FR 24981, June 12, 1992; 57 FR 
33896, July 31, 1992; 58 FR 30668, May 26, 1993; 59 FR 26959, May 25, 
1994; 59 FR 49833, Sept. 30, 1994; 60 FR 8955, Feb. 16, 1995; 63 FR 
20128, Apr. 23, 1998; 66 FR 55328, Nov. 1, 2001]

Sec. 410.12  Medical and other health services: Basic conditions and 
          limitations.

    (a) Basic conditions. The medical and other health services 
specified in Sec. 410.10 are covered by Medicare Part B only if they are 
not excluded under subpart A of part 411 of this chapter, and if they 
meet the following conditions:
    (1) When the services must be furnished. The services must be 
furnished while the individual is in a period of entitlement. (The rules 
on entitlement are set forth in part 406 of this chapter.)
    (2) By whom the services must be furnished. The services must be 
furnished by a facility or other entity as specified in Secs. 410.14 
through 410.69.
    (3) Physician certification and recertification requirements. If the 
services are subject to physician certification requirements, they must 
be certified as being medically necessary, and as meeting other 
applicable requirements, in accordance with subpart B of part 424 of 
this chapter.
    (b) Limitations on payment. Payment for medical and other health 
services is subject to limitations on the amounts of payment as 
specified in Secs. 410.152 and 410.155 and to the annual and blood 
deductibles as set forth in Secs. 410.160 and 410.161.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 57 
FR 33896, July 31, 1992]

Sec. 410.14  Special requirements for services furnished outside the 
          United States.

    Medicare part B pays for physicians' services and ambulance services 
furnished outside the United States if the services meet the applicable 
conditions of Sec. 410.12 and are furnished in connection with covered 
inpatient hospital services that meet the specific requirements and 
conditions set forth in subpart H of part 424 of this chapter.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988]

Sec. 410.20  Physicians' services.

    (a) Included services. Medicare Part B pays for physicians' 
services, including diagnosis, therapy, surgery, consultations, and 
home, office, and institutional calls.
    (b) By whom services must be furnished. Medicare Part B pays for the 
services specified in paragraph (a) of this section if they are 
furnished by one of the following professionals who is legally 
authorized to practice by the State in which he or she performs the 
functions or actions, and who is acting within the <STRONG>scope</STRONG> of his or her 
license.
    (1) A doctor of medicine or osteopathy, including an osteopathic 
practitioner recognized in section 1101(a)(7) of the Act.
    (2) A doctor of dental surgery or dental medicine.
    (3) A doctor of podiatric medicine.
    (4) A doctor of optometry.

[[Page 246]]

    (5) A chiropractor who meets the qualifications specified in 
Sec. 410.22
    (c) Limitations on services. The Services specified in paragraph (a) 
of this section may be covered under Medicare Part B if they are 
furnished within the limitations specified in Secs. 410.22 through 
410.25.

Sec. 410.21  Limitations on services of a chiropractor.

    (a) Qualifications for chiropractors. (1) A chiropractor licensed or 
authorized to practice before July 1, 1974, and an individual who began 
studies in a chiropractic college before that date, must have--
    (i) Had preliminary education equal to the requirements for 
graduation from an accredited high school or other secondary school;
    (ii) Graduated from a college of chiropractic approved by the 
State's chiropractic examiners after completing a course of study 
covering a period of not less than 3 school years of 6 months each year 
in actual continuous attendance and covering adequate courses of study 
in the subjects of anatomy, physiology, symptomatology and diagnosis, 
hygiene and sanitation, chemistry, histology, pathology, and principles 
and practice of chiropractic, including clinical instruction in 
vertebral palpation, nerve tracing and adjusting; and
    (iii) Passed an examination prescribed by the State's chiropractic 
examiners covering the subjects specified in paragraph (a)(1)(ii) of 
this section.
    (2) A chiropractor first licensed or authorized to practice after 
June 30, 1974, and an individual who begins studies in a chiropractic 
college after that date, must have--
    (i) Had preliminary education equal to the requirements for 
graduation from an accredited high school or other secondary school;
    (ii) Satisfactorily completed 2 years of pre-chiropractic study at 
the college level;
    (iii) Satisfactorily completed a 4-year course of 8 months each year 
offered by a college or school of chiropractic approved by the State's 
chiropractic examiners and including at least 4,000 hours in courses in 
anatomy, physiology, symptomatology and diagnosis, hygiene and 
sanitation, chemistry, histology, pathology, principles and practice of 
chiropractic, and clinical instruction in vertebral palpation, nerve 
tracing and adjusting, plus courses in the use and effect of X-ray and 
chiropractic analysis;
    (iv) Passed an examination prescribed by the State's chiropractic 
examiners covering the subjects specified in paragraph (a)(2)(iii) of 
this section; and
    (v) Attained 21 years of age.
    (b) Limitations on services. (1) Medicare Part B pays only for a 
chiropractor's manual manipulation of the spine to correct a subluxation 
if the subluxation has resulted in a neuromusculoskeletal condition for 
which manual manipulation is appropriate treatment.
    (2) Medicare Part B does not pay for X-rays or other diagnostic or 
therapeutic services furnished or ordered by a chiropractor.

[51 FR 41339, Nov. 14, 1986, as amended at 64 FR 59439, Nov. 2, 1999. 
Redesignated at 66 FR 55328, Nov. 1, 2001]

Sec. 410.22  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 Sec. 410.10 of this part.

[64 FR 59439, Nov. 2, 1999. Redesignated at 66 FR 55328, Nov. 1, 2001]

Sec. 410.23  Screening for glaucoma: Conditions for and limitations on 
          coverage.

    (a) Definitions: As used in this section, the following definitions 
apply:
    (1) Direct supervision in the office setting means the optometrist 
or the ophthalmologist must be present in the office suite and be 
immediately available to furnish assistance and direction throughout the 
performance of the procedure. It does not mean the physician must be 
present in the room when the procedure is performed.
    (2) Eligible beneficiary means individuals in the following high 
risk categories:
    (i) Individual with diabetes mellitus;

[[Page 247]]

    (ii) Individual with a family history of glaucoma; or
    (iii) African-Americans age 50 and over.
    (3) Screening for glaucoma means the following procedures furnished 
to an individual for the early detection of glaucoma:
    (i) A dilated eye examination with an intraocular pressure 
measurement.
    (ii) A direct ophthalmoscopy examination, or a slit-lamp 
biomicroscopic examination.
    (b) Condition for coverage of screening for glaucoma.
    Medicare Part B pays for glaucoma screening examinations provided to 
eligible beneficiaries as described in paragraph (a)(2) of this section 
if they are furnished by or under the direct supervision in the office 
setting of an optometrist or ophthalmologist who is legally authorized 
to perform these services under State law (or the State regulatory 
mechanism provided by State law) of the State in which the services are 
furnished, as would otherwise be covered if furnished by a physician or 
incident to a physician's professional service.
    (c) Limitations on coverage of glaucoma screening examinations.
    (1) Payment may not be made for a glaucoma screening examination 
that is performed for an individual who is not an eligible beneficiary 
as described in paragraph (a)(2) of this section.
    (2) Payment may be made for a glaucoma screening examination that is 
performed on an individual who is an eligible beneficiary as described 
in paragraph (a)(2) of this section, after at least 11 months have 
passed following the month in which the last glaucoma screening 
examination was performed.

[66 FR 55328, Nov. 1, 2001]

Sec. 410.24  Limitations on services of a doctor of dental surgery or 
          dental medicine.

    Medicare Part B pays for services furnished by a doctor of dental 
surgery or dental medicine within the <STRONG>scope</STRONG> of his or her license, if 
the services would be covered as physicians' services when performed by 
a doctor of medicine or osteopathy.&lt;SUP&gt;1&lt;/SUP&gt;
---------------------------------------------------------------------------

    \1\ For services furnished before July 1, 1981, Medicare Part B paid 
only for the following services of a doctor of dental surgery or dental 
medicine;
    Surgery on the jaw or any adjoining structure; and
    Reduction of a fracture of the jaw or other facial bone.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 8852, Mar. 1, 1991]

Sec. 410.25  Limitations on services of a podiatrist.

    Medicare Part B pays for the services of a doctor of podiatric 
medicine, acting within the <STRONG>scope</STRONG> of his or her license, if the services 
would be covered as physicians' services when performed by a doctor of 
medicine or osteopathy.

Sec. 410.26  Services and supplies incident to a physician's 
          professional services: Conditions.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    (1) Auxiliary personnel means any individual who is acting under the 
supervision of a physician (or other practitioner), regardless of 
whether the individual is an employee, leased employee, or independent 
contractor of the physician (or other practitioner) or of the same 
entity that employs or contracts with the physician (or other 
practitioner).
    (2) Direct supervision means the level of supervision by the 
physician (or other practitioner) of auxiliary personnel as defined in 
Sec. 410.32(b)(3)(ii).
    (3) Independent contractor means an individual (or an entity that 
has hired such an individual) who performs part-time or full-time work 
for which the individual (or the entity that has hired such an 
individual) receives an IRS-1099 form.
    (4) Leased employment means an employment relationship that is 
recognized by applicable State law and that is established by two 
employers by a contract such that one employer hires the services of an 
employee of the other employer.
    (5) Noninstitutional setting means all settings other than a 
hospital or skilled nursing facility.

[[Page 248]]

    (6) Practitioner means a non-physician practitioner who is 
authorized by the Act to receive payment for services incident to his or 
her own services.
    (7) Services and supplies means any services or supplies (including 
drugs or biologicals that are not usually self-administered) that are 
included in section 1861(s)(2)(A) of the Act and are not specifically 
listed in the Act as a separate benefit included in the Medicare 
program.
    (b) Medicare Part B pays for services and supplies incident to the 
service of a physician (or other practitioner).
    (1) Services and supplies must be furnished in a noninstitutional 
setting to noninstitutional patients.
    (2) Services and supplies must be an integral, though incidental, 
part of the service of a physician (or other practitioner) in the course 
of diagnosis or treatment of an injury or illness.
    (3) Services and supplies must be commonly furnished without charge 
or included in the bill of a physician (or other practitioner).
    (4) Services and supplies must be of a type that are commonly 
furnished in the office or clinic of a physician (or other 
practitioner).
    (5) Services and supplies must be furnished under the direct 
supervision of the physician (or other practitioner). The physician (or 
other practitioner) directly supervising the auxiliary personnel need 
not be the same physician (or other practitioner) upon whose 
professional service the incident to service is based.
    (6) Services and supplies must be furnished by the physician, 
practitioner with an incident to benefit, or auxiliary personnel.
    (7) A physician (or other practitioner) may be an employee or an 
independent contractor.
    (c) Limitation. Drugs and biologicals are also subject to the 
limitations specified in Sec. 410.29.

[51 FR 41339, Nov. 14, 1986, as amended at 66 FR 55328, Nov. 1, 2001; 67 
FR 20684, Apr. 26, 2002]

Sec. 410.27  Outpatient hospital services and supplies incident to a 
          physician service: Conditions.

    (a) Medicare Part B pays for hospital services and supplies 
furnished incident to a physician service to outpatients, including 
drugs and biologicals that cannot be self-administered, if--
    (1) They are furnished--
    (i) By or under arrangements made by a participating hospital, 
except in the case of an SNF resident as provided in Sec. 411.15(p) of 
this chapter;
    (ii) As an integral though incidental part of a physician's 
services; and
    (iii) In the hospital or at a location (other than an RHC or an 
FQHC) that CMS designates as a department of a provider under 
Sec. 413.65 of this chapter; and
    (2) In the case of partial hospitalization services, also meet the 
conditions of paragraph (d) of this section.
    (b) Drugs and biologicals are also subject to the limitations 
specified in Sec. 410.168.
    (c) Rules on emergency services furnished to outpatients by 
nonparticipating hospitals are specified in Sec. 410.168.
    (d) Medicare Part B pays for partial hospitalization services if 
they are--
    (1) Prescribed by a physician who certifies and recertifies the need 
for the services in accordance with subpart B of part 424 of this 
chapter; and
    (2) Furnished under a plan of treatment as required under subpart B 
of part 424 of this chapter.
    (e) Services furnished by an entity other than the hospital are 
subject to the limitations specified in Sec. 410.42(a).
    (f) Services furnished at a location (other than an RHC or an FQHC) 
that CMS designates as a department of a provider under Sec. 413.65 of 
this chapter must be under the direct supervision of a physician. 
``Direct supervision'' means the physician must be present and on the 
premises of the location and immediately available to furnish assistance 
and direction throughout the performance of the procedure. It does not 
mean that the physician must be present in the room when the procedure 
is performed.

[56 FR 8841, Mar. 1, 1991, as amended at 63 FR 26307, May 12, 1998; 65 
FR 18536, Apr. 7, 2000]

Sec. 410.28  Hospital or CAH diagnostic services furnished to 
          outpatients: Conditions.

    (a) Medicare Part B pays for hospital or CAH diagnostic services 
furnished to

[[Page 249]]

outpatients, including drugs and biologicals required in the performance 
of the services (even if those drugs or biologicals are self-
administered), if those services meet the following conditions:
    (1) They are furnished by or under arrangements made by a 
participating hospital or participating CAH, except in the case of an 
SNF resident as provided in Sec. 411.15(p) of this chapter.
    (2) They are ordinarily furnished by, or under arrangements made by, 
the hospital or CAH to its outpatients for the purpose of diagnostic 
study.
    (3) They would be covered as inpatient hospital services if 
furnished to an inpatient.
    (b) Drugs and biologicals are also subject to the limitations 
specified in Sec. 410.29(b) and (c).
    (c) Diagnostic services furnished by an entity other than the 
hospital or CAH are subject to the limitations specified in 
Sec. 410.42(a).
    (d) Rules on emergency services furnished to outpatients by 
nonparticipating hospitals are set forth in subpart G of part 424 of 
this chapter.
    (e) Medicare Part B makes payment under section 1833(t) of the Act 
for diagnostic services furnished at a facility (other than an RHC or an 
FQHC) that CMS designates as having provider-based status only when the 
diagnostic services are furnished under the appropriate level of 
physician supervision specified by CMS in accordance with the 
definitions in Sec. 410.32(b)(3)(i), (b)(3)(ii), and (b)(3)(iii). Under 
general supervision at a facility accorded provider-based status, the 
training of the nonphysician personnel who actually perform the 
diagnostic procedure and the maintenance of the necessary equipment and 
supplies are the continuing responsibility of the facility.
    (f) The rules for clinical diagnostic laboratory tests set forth in 
Secs. 410.32(a) and (d)(2) through (d)(4) of this subpart are applicable 
to those tests when furnished in hospitals and CAHs.

[51 FR 41339, Nov. 14, 1986, as amended at 58 FR 30668, May 26, 1993; 63 
FR 26307, May 12, 1998; 65 FR 18536, Apr. 7, 2000; 66 FR 58809, Nov. 23, 
2001]

Sec. 410.29  Limitations on drugs and biologicals.

    Medicare part B does not pay for the following:
    (a) Except as provided in Sec. 410.28(a) for outpatient diagnostic 
services and Sec. 410.63(b) for blood clotting factors, and except for 
EPO, any drug or biological that can be self-administered.
    (b) Any drug product that meets all of the following conditions:
    (1) The drug product was approved by the Food and Drug 
Administration (FDA) before October 10, 1962.
    (2) The drug product is available only through prescription.
    (3) The drug product is the subject of a notice of opportunity for 
hearing issued under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act and published in the Federal Register on a proposed order 
of FDA to withdraw its approval for the drug product because it has 
determined that the product is less than effective for all its labeled 
indications.
    (4) The drug product is presently not subject to a determination by 
FDA, made under its efficacy review program, that there is a compelling 
justification of the drug product's medical need. (21 CFR 310.6 contains 
an explanation of the efficacy review program.)
    (c) Any drug product that is identical, related, or similar, as 
defined in 21 CFR 310.6, to a drug product that meets the conditions of 
paragraph (b) of this section.

[51 FR 41339, Nov. 14, 1986, as amended at 55 FR 22790, June 4, 1990; 56 
FR 43709, Sept. 4, 1991]

Sec. 410.30  Prescription drugs used in immunosuppressive therapy.

    (a) <STRONG>Scope</STRONG>. Payment may be made for prescription drugs used in 
immunosuppressive therapy that have been approved for marketing by the 
FDA and that meet one of the following conditions:
    (1) The approved labeling includes the indication for preventing or 
treating the rejection of a transplanted organ or tissue.
    (2) The approved labeling includes the indication for use in 
conjunction with immunosuppressive drugs to prevent or treat rejection 
of a transplanted organ or tissue.

[[Page 250]]

    (3) Have been determined by a carrier (in accordance with part 421, 
subpart C of this chapter), in processing a Medicare claim, to be 
reasonable and necessary for the specific purpose of preventing or 
treating the rejection of a patient's transplanted organ or tissue, or 
for use in conjunction with immunosuppressive drugs for the purpose of 
preventing or treating the rejection of a patient's transplanted organ 
or tissue. (In making these determinations, the carriers may consider 
factors such as authoritative drug compendia, current medical 
literature, recognized standards of medical practice, and professional 
medical publications.)
    (b) Period of eligibility. Coverage is available only for 
prescription drugs used in immunosuppressive therapy, furnished to an 
individual who receives an organ or tissue transplant for which Medicare 
payment is made, for the following periods:
    (1) For drugs furnished before 1995, for a period of up to 1 year 
beginning with the date of discharge from the hospital during which the 
covered transplant was performed.
    (2) For drugs furnished during 1995, within 18 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (3) For drugs furnished during 1996, within 24 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (4) For drugs furnished during 1997, within 30 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (5) For drugs furnished after 1997, within 36 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (c) Coverage. Drugs are covered under this provision irrespective of 
whether they can be self-administered.

[60 FR 8955, Feb. 16, 1995. Redesignated at 63 FR 34327, June 24, 1998]

Sec. 410.31  Bone mass measurement: Conditions for coverage and 
          frequency standards.

    (a) Definition. As used in this section unless specified otherwise, 
the following definition applies:
    Bone mass measurement means a radiologic, radioisotopic, or other 
procedure that meets the following conditions:
    (1) Is performed for the purpose of identifying bone mass, detecting 
bone loss, or determining bone quality.
    (2) Is performed with either a bone densitometer (other than dual-
photon absorptiometry) or with a bone sonometer system that has been 
cleared for marketing for this use by the FDA under 21 CFR part 807, or 
approved for marketing by the FDA for this use under 21 CFR part 814.
    (3) Includes a physician's interpretation of the results of the 
procedure.
    (b) Conditions for coverage. Medicare covers a medically necessary 
bone mass measurement if the following conditions are met:
    (1) Following an evaluation of the beneficiary's need for the 
measurement, including a determination as to the medically appropriate 
procedure to be used for the beneficiary, it is ordered by the physician 
or a qualified nonphysician practitioner (as these terms are defined in 
Sec. 410.32(a)) treating the beneficiary.
    (2) It is performed under the appropriate level of supervision of a 
physician (as set forth in Sec. 410.32(b)).
    (3) It is reasonable and necessary for diagnosing, treating, or 
monitoring the condition of a beneficiary who meets the conditions 
described in paragraph (d) of this section.
    (c) Standards on frequency of coverage--(1) General rule. Except as 
allowed under paragraph (c)(2) of this section, Medicare may cover a 
bone mass measurement for a beneficiary if at least 23 months have 
passed since the month the last bone mass measurement was performed.
    (2) Exception. If medically necessary, Medicare may cover a bone 
mass measurement for a beneficiary more frequently than allowed under 
paragraph (c)(1) of this section. Examples of situations where more 
frequent bone mass measurement procedures may be medically necessary 
include, but are not limited to, the following medical circumstances:
    (i) Monitoring beneficiaries on long-term glucocorticoid (steroid) 
therapy of more than 3 months.
    (ii) Allowing for a confirmatory baseline bone mass measurement 
(either

[[Page 251]]

central or peripheral) to permit monitoring of beneficiaries in the 
future if the initial test was performed with a technique that is 
different from the proposed monitoring method.
    (d) Beneficiaries who may be covered. The following categories of 
beneficiaries may receive Medicare coverage for a medically necessary 
bone mass measurement:
    (1) A woman who has been determined by the physician (or a qualified 
nonphysician practitioner) treating her to be estrogen-deficient and at 
clinical risk for osteoporosis, based on her medical history and other 
findings.
    (2) An individual with vertebral abnormalities as demonstrated by an 
x-ray to be indicative of osteoporosis, osteopenia, or vertebral 
fracture.
    (3) An individual receiving (or expecting to receive) glucocorticoid 
(steroid) therapy equivalent to 7.5 mg of prednisone, or greater, per 
day for more than 3 months.
    (4) An individual with primary hyperparathyroidism.
    (5) An individual being monitored to assess the response to or 
efficacy of an FDA-approved osteoporosis drug therapy.
    (e) Denial as not reasonable and necessary. If CMS determines that a 
bone mass measurement does not meet the conditions for coverage in 
paragraphs (b) or (d) of this section, or the standards on frequency of 
coverage in paragraph (c) of this section, it is excluded from Medicare 
coverage as not ``reasonable'' and ``necessary'' under section 
1862(a)(1)(A) of the Act and Sec. 411.15(k) of this chapter.

[63 FR 34327, June 24, 1998]

Sec. 410.32  Diagnostic x-ray tests, diagnostic laboratory tests, and 
          other diagnostic tests: Conditions.

    (a) Ordering diagnostic tests. All diagnostic x-ray tests, 
diagnostic laboratory tests, and other diagnostic tests must be ordered 
by the physician who is treating the beneficiary, that is, the physician 
who furnishes a consultation or treats a beneficiary for a specific 
medical problem and who uses the results in the management of the 
beneficiary's specific medical problem. Tests not ordered by the 
physician who is treating the beneficiary are not reasonable and 
necessary (see Sec. 411.15(k)(1) of this chapter).
    (1) Chiropractic exception. A physician may order an x-ray to be 
used by a chiropractor to demonstrate the subluxation of the spine that 
is the basis for a beneficiary to receive manual manipulation treatments 
even though the physician does not treat the beneficiary.
    (2) Mammography exception. A physician who meets the qualification 
requirements for an interpreting physician under section 354 of the 
Public Health Service Act as provided in Sec. 410.34(a)(7) may order a 
diagnostic mammogram based on the findings of a screening mammogram even 
though the physician does not treat the beneficiary.
    (3) Application to nonphysician practitioners. Nonphysician 
practitioners (that is, clinical nurse specialists, clinical 
psychologists, clinical social workers, nurse-midwives, nurse 
practitioners, and physician assistants) who furnish services that would 
be physician services if furnished by a physician, and who are operating 
within the <STRONG>scope</STRONG> of their authority under State law and within the <STRONG>scope</STRONG> 
of their Medicare statutory benefit, may be treated the same as 
physicians treating beneficiaries for the purpose of this paragraph.
    (b) Diagnostic x-ray and other diagnostic tests--(1) Basic rule. 
Except as indicated in paragraph (b)(2) of this section, all diagnostic 
x-ray and other diagnostic tests covered under section 1861(s)(3) of the 
Act and payable under the physician fee schedule must be furnished under 
the appropriate level of supervision by a physician as defined in 
section 1861(r) of the Act. Services furnished without the required 
level of supervision are not reasonable and necessary (see 
Sec. 411.15(k)(1) of this chapter).
    (2) Exceptions. The following diagnostic tests payable under the 
physician fee schedule are excluded from the basic rule set forth in 
paragraph (b)(1) of this section:
    (i) Diagnostic mammography procedures, which are regulated by the 
Food and Drug Administration.

[[Page 252]]

    (ii) Diagnostic tests personally furnished by a qualified 
audiologist as defined in section 1861(ll)(3) of the Act.
    (iii) Diagnostic psychological testing services personally furnished 
by a clinical psychologist or a qualified independent psychologist as 
defined in program instructions.
    (iv) Diagnostic tests (as established through program instructions) 
personally performed by a physical therapist who is certified by the 
American Board of Physical Therapy Specialties as a qualified 
electrophysiologic clinical specialist and permitted to provide the 
service under State law.
    (v) Diagnostic tests performed by a nurse practitioner or clinical 
nurse specialist authorized to perform the tests under applicable State 
laws.
    (vi) Pathology and laboratory procedures listed in the 80000 series 
of the Current Procedural Terminology published by the American Medical 
Association.
    (3) Levels of supervision. Except where otherwise indicated, all 
diagnostic x-ray and other diagnostic tests subject to this provision 
and payable under the physician fee schedule must be furnished under at 
least a general level of physician supervision as defined in paragraph 
(b)(3)(i) of this section. In addition, some of these tests also require 
either direct or personal supervision as defined in paragraphs 
(b)(3)(ii) or (b)(3)(iii) of this section, respectively. (However, 
diagnostic tests performed by a physician assistant (PA) that the PA is 
legally authorized to perform under State law require only a general 
level of physician supervision.) When direct or personal supervision is 
required, physician supervision at the specified level is required 
throughout the performance of the test.
    (i) General supervision means the procedure is furnished under the 
physician's overall direction and control, but the physician's presence 
is not required during the performance of the procedure. Under general 
supervision, the training of the nonphysician personnel who actually 
perform the diagnostic procedure and the maintenance of the necessary 
equipment and supplies are the continuing responsibility of the 
physician.
    (ii) Direct supervision in the office setting means the physician 
must be present in the office suite and immediately available to furnish 
assistance and direction throughout the performance of the procedure. It 
does not mean that the physician must be present in the room when the 
procedure is performed.
    (iii) Personal supervision means a physician must be in attendance 
in the room during the performance of the procedure.
    (c) Portable x-ray services. Portable x-ray services furnished in a 
place of residence used as the patient's home are covered if the 
following conditions are met:
    (1) These services are furnished under the general supervision of a 
physician, as defined in paragraph (b)(3)(i) of this section.
    (2) The supplier of these services meets the requirements set forth 
in part 486, subpart C of this chapter, concerning conditions for 
coverage for portable x-ray services.
    (3) The procedures are limited to--
    (i) Skeletal films involving the extremities, pelvis, vertebral 
column, or skull;
    (ii) Chest or abdominal films that do not involve the use of 
contrast media; and
    (iii) Diagnostic mammograms if the approved portable x-ray supplier, 
as defined in subpart C of part 486 of this chapter, meets the 
certification requirements of section 354 of the Public Health Service 
Act, as implemented by 21 CFR part 900, subpart B.
    (d) Diagnostic laboratory tests. (1) Who may furnish services. 
Medicare Part B pays for covered diagnostic laboratory tests that are 
furnished by any of the following:
    (i) A participating hospital or participating RPCH.
    (ii) A nonparticipating hospital that meets the requirements for 
emergency outpatient services specified in subpart G of part 424 of this 
chapter and the laboratory requirements specified in part 493 of this 
chapter.
    (iii) The office of the patient's attending or consulting physician 
if that physician is a doctor of medicine, osteopathy, podiatric 
medicine, dental surgery, or dental medicine.

[[Page 253]]

    (iv) An RHC.
    (v) A laboratory, if it meets the applicable requirements for 
laboratories of part 493 of this chapter, including the laboratory of a 
nonparticipating hospital that does not meet the requirements for 
emergency outpatient services in subpart G of part 424 of this chapter.
    (vi) An FQHC.
    (vii) An SNF to its resident under Sec. 411.15(p) of this chapter, 
either directly (in accordance with Sec. 483.75(k)(1)(i) of this 
chapter) or under an arrangement (as defined in Sec. 409.3 of this 
chapter) with another entity described in this paragraph.
    (2) Documentation and recordkeeping requirements.
    (i) Ordering the service. The physician or (qualified nonphysican 
practitioner, as defined in paragraph (a)(3) of this section), who 
orders the service must maintain documentation of medical necessity in 
the beneficiary's medical record.
    (ii) Submitting the claim. The entity submitting the claim must 
maintain the following documentation:
    (A) The documentation that it receives from the ordering physician 
or nonphysician practitioner.
    (B) The documentation that the information that it submitted with 
the claim accurately reflects the information it received from the 
ordering physician or nonphysician practitioner.
    (iii) Requesting additional information. The entity submitting the 
claim may request additional diagnostic and other medical information to 
document that the services it bills are reasonable and necessary. If the 
entity requests additional documentation, it must request material 
relevant to the medical necessity of the specific test(s), taking into 
consideration current rules and regulations on patient confidentiality.
    (3) Claims review. (i) Documentation requirements. Upon request by 
CMS, the entity submitting the claim must provide the following 
information:
    (A) Documentation of the order for the service billed (including 
information sufficient to enable CMS to identify and contact the 
ordering physician or nonphysician practitioner).
    (B) Documentation showing accurate processing of the order and 
submission of the claim.
    (C) Diagnostic or other medical information supplied to the 
laboratory by the ordering physician or nonphysician practitioner, 
including any ICD-9-CM code or narrative description supplied.
    (ii) Services that are not reasonable and necessary. If the 
documentation provided under paragraph (d)(3)(i) of this section does 
not demonstrate that the service is reasonable and necessary, CMS takes 
the following actions:
    (A) Provides the ordering physician or nonphysician practitioner 
information sufficient to identify the claim being reviewed.
    (B) Requests from the ordering physician or nonphysician 
practitioner those parts of a beneficiary's medical record that are 
relevant to the specific claim(s) being reviewed.
    (C) If the ordering physician or nonphysician practitioner does not 
supply the documentation requested, informs the entity submitting the 
claim(s) that the documentation has not been supplied and denies the 
claim.
    (iii) Medical necessity. The entity submitting the claim may request 
additional diagnostic and other medical information from the ordering 
physician or nonphysician practitioner to document that the services it 
bills are reasonable and necessary. If the entity requests additional 
documentation, it must request material relevant to the medical 
necessity of the specific test(s), taking into consideration current 
rules and regulations on patient confidentiality.
    (4) Automatic denial and manual review. (i) General rule. Except as 
provided in paragraph (d)(4)(ii) of this section, CMS does not deny a 
claim for services that exceed utilization parameters without reviewing 
all relevant documentation that is submitted with the claim (for 
example, justifications prepared by providers, primary and secondary 
diagnoses, and copies of medical records).
    (ii) Exceptions. CMS may automatically deny a claim without manual 
review if a national coverage decision or LMRP specifies the 
circumstances under which the service is denied, or

[[Page 254]]

the service is specifically excluded from Medicare coverage by law.
    (e) Diagnostic laboratory tests furnished in hospitals and CAHs. The 
provisions of paragraphs (a) and (d)(2) through (d)(4), inclusive, of 
this section apply to all diagnostic laboratory test furnished by 
hospitals and CAHs to outpatients.

[62 FR 59098, Oct. 31, 1997, as amended at 63 FR 26308, May 12, 1998; 63 
FR 53307, Oct. 5, 1998; 63 FR 58906, Nov. 2, 1998; 64 FR 59440, Nov. 2, 
1999; 66 FR 58809, Nov. 23, 2001]

Sec. 410.33  Independent diagnostic testing facility.

    (a) General rule. (1) Effective for diagnostic procedures performed 
on or after March 15, 1999, carriers will pay for diagnostic procedures 
under the physician fee schedule only when performed by a physician, a 
group practice of physicians, an approved supplier of portable x-ray 
services, a nurse practitioner, or a clinical nurse specialist when he 
or she performs a test he or she is authorized by the State to perform, 
or an independent diagnostic testing facility (IDTF). An IDTF may be a 
fixed location, a mobile entity, or an individual nonphysician 
practitioner. It is independent of a physician's office or hospital; 
however, these rules apply when an IDTF furnishes diagnostic procedures 
in a physician's office.
    (2) Exceptions. The following diagnostic tests that are payable 
under the physician fee schedule and furnished by a nonhospital testing 
entity are not required to be furnished in accordance with the criteria 
set forth in paragraphs (b) through (e) of this section:
    (i) Diagnostic mammography procedures, which are regulated by the 
Food and Drug Administration.
    (ii) Diagnostic tests personally furnished by a qualified 
audiologist as defined in section 1861(ll)(3) of the Act.
    (iii) Diagnostic psychological testing services personally furnished 
by a clinical psychologist or a qualified independent psychologist as 
defined in program instructions.
    (iv) Diagnostic tests (as established through program instructions) 
personally performed by a physical therapist who is certified by the 
American Board of Physical Therapy Specialties as a qualified 
electrophysiologic clinical specialist and permitted to provide the 
service under State law.
    (b) Supervising physician. (1) An IDTF must have one or more 
supervising physicians who are responsible for the direct and ongoing 
oversight of the quality of the testing performed, the proper operation 
and calibration of the equipment used to perform tests, and the 
qualification of nonphysician personnel who use the equipment. This 
level of supervision is that required for general supervision set forth 
in Sec. 410.32(b)(3)(i).
    (2) The supervising physician must evidence proficiency in the 
performance and interpretation of each type of diagnostic procedure 
performed by the IDTF. The proficiency may be documented by 
certification in specific medical specialties or subspecialties or by 
criteria established by the carrier for the service area in which the 
IDTF is located. In the case of a procedure requiring the direct or 
personal supervision of a physician as set forth in 
Sec. 410.32(b)(3)(ii) or (b)(3)(iii), the IDTF's supervising physician 
must personally furnish this level of supervision whether the procedure 
is performed in the IDTF or, in the case of mobile services, at the 
remote location. The IDTF must maintain documentation of sufficient 
physician resources during all hours of operations to assure that the 
required physician supervision is furnished. In the case of procedures 
requiring direct supervision, the supervising physician may oversee 
concurrent procedures.
    (c) Nonphysician personnel. Any nonphysician personnel used by the 
IDTF to perform tests must demonstrate the basic qualifications to 
perform the tests in question and have training and proficiency as 
evidenced by licensure or certification by the appropriate State health 
or education department. In the absence of a State licensing board, the 
technician must be certified by an appropriate national credentialing 
body. The IDTF must maintain documentation available for review that 
these requirements are met.
    (d) Ordering of tests. All procedures performed by the IDTF must be 
specifically ordered in writing by the physician who is treating the 
beneficiary,

[[Page 255]]

that is, the physician who is furnishing a consultation or treating a 
beneficiary for a specific medical problem and who uses the results in 
the management of the beneficiary's specific medical problem. 
(Nonphysician practitioners may order tests as set forth in 
Sec. 410.32(a)(3).) The order must specify the diagnosis or other basis 
for the testing. The supervising physician for the IDTF may not order 
tests to be performed by the IDTF, unless the IDTF's supervising 
physician is in fact the beneficiary's treating physician. That is, the 
physician in question had a relationship with the beneficiary prior to 
the performance of the testing and is treating the beneficiary for a 
specific medical problem. The IDTF may not add any procedures based on 
internal protocols without a written order from the treating physician.
    (e) Multi-State entities. An IDTF that operates across State 
boundaries must maintain documentation that its supervising physicians 
and technicians are licensed and certified in each of the States in 
which it is furnishing services.
    (f) Applicability of State law. An IDTF must comply with the 
applicable laws of any State in which it operates.

[62 FR 59099, Oct. 31, 1997, as amended at 64 FR 59440, Nov. 2, 1999]

Sec. 410.34  Mammography services: Conditions for and limitations on 
          coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    (1) Diagnostic mammography means a radiologic procedure furnished to 
a man or woman with signs or symptoms of breast disease, or a personal 
history of breast cancer, or a personal history of biopsy-proven benign 
breast disease, and includes a physician's interpretation of the results 
of the procedure.
    (2) Screening mammography means a radiologic procedure furnished to 
a woman without signs or symptoms of breast disease, for the purpose of 
early detection of breast cancer, and includes a physician's 
interpretation of the results of the procedure.
    (3) Supplier of diagnostic mammography means a facility that is 
certified and responsible for ensuring that all diagnostic mammography 
services furnished to Medicare beneficiaries meet the conditions for 
coverage of diagnostic mammography services as specified in paragraph 
(b) of this section.
    (4) Supplier of screening mammography means a facility that is 
certified and responsible for ensuring that all screening mammography 
services furnished to Medicare beneficiaries meet the conditions and 
limitations for coverage of screening mammography services as specified 
in paragraphs (c) and (d) of this section.
    (5) Certificate means the certificate described in 21 CFR 900.2(b) 
that may be issued to, or renewed for, a facility that meets the 
requirements for conducting an examination or procedure involving 
mammography.
    (6) Provisional certificate means the provisional certificate 
described in 21 CFR 900.2(m) that may be issued to a facility to enable 
the facility to qualify to meet the requirements for conducting an 
examination or procedure involving mammography.
    (7) The term meets the certification requirements of section 354 of 
the Public Health Service (PHS) Act means that in order to qualify for 
coverage of its services under the Medicare program, a supplier of 
diagnostic or screening mammography services must meet the following 
requirements:
    (i) Must have a valid provisional certificate, or a valid 
certificate, that has been issued by FDA indicating that the supplier 
meets the certification requirements of section 354 of the PHS Act, as 
implemented by 21 CFR part 900, subpart B.
    (ii) Has not been issued a written notification by FDA that states 
that the supplier must cease conducting mammography examinations because 
the supplier is not in compliance with certain critical certification 
requirements of section 354 of the PHS Act, implemented by 21 CFR part 
900, subpart B.
    (iii) Must not employ for provision of the professional component of 
mammography services a physician or physicians for whom the facility has 
received written notification by FDA that the physician (or physicians) 
is (or are) in violation of the certification requirements set forth in 
section 354 of the PHS Act, as implemented by 21 CFR 900.12(a)(1)(i).

[[Page 256]]

    (b) Conditions for coverage of diagnostic mammography services. 
Medicare Part B pays for diagnostic mammography services if they meet 
the following conditions:
    (1) They are ordered by a doctor of medicine or osteopathy (as 
defined in section 1861(r)(1) of the Act).
    (2) They are furnished by a supplier of diagnostic mammography 
services that meets the certification requirements of section 354 of the 
PHS Act, as implemented by 21 CFR part 900, subpart B.
    (c) Conditions for coverage of screening mammography services. 
Medicare Part B pays for screening mammography services if they are 
furnished by a supplier of screening mammography services that meets the 
certification requirements of section 354 of the PHS Act, as implemented 
by 21 CFR part 900, subpart B.
    (d) Limitations on coverage of screening mammography services. The 
following limitations apply to coverage of screening mammography 
services as described in paragraphs (c) and (d) of this section:
    (1) The service must be, at a minimum a two-view exposure (that is, 
a cranio-caudal and a medial lateral oblique view) of each breast.
    (2) Payment may not be made for screening mammography performed on a 
woman under age 35.
    (3) Payment may be made for only 1 screening mammography performed 
on a woman over age 34, but under age 40.
    (4) For an asymptomatic woman over 39 years of age, payment may be 
made for a screening mammography performed after at least 11 months have 
passed following the month in which the last screening mammography was 
performed.

[59 FR 49833, Sept. 30, 1994, as amended at 60 FR 14224, Mar. 16, 1995; 
60 FR 63176, Dec. 8, 1995; 62 FR 59100, Oct. 31, 1997; 63 FR 4596, Jan. 
30, 1998]

Sec. 410.35  X-ray therapy and other radiation therapy services: <STRONG>Scope</STRONG>.

    Medicare Part B pays for X-ray therapy and other radiation therapy 
services, including radium therapy and radioactive isotope therapy, and 
materials and the services of technicians administering the treatment.

[51 FR 41339, Nov. 14, 1986. Redesignated at 55 FR 53522, Dec. 31, 1990]

Sec. 410.36  Medical supplies, appliances, and devices: <STRONG>Scope</STRONG>.

    (a) Medicare Part B pays for the following medical supplies, 
appliances and devices:
    (1) Surgical dressings, and splints, casts, and other devices used 
for reduction of fractures and dislocations.
    (2) Prosthetic devices, other than dental, that replace all or part 
of an internal body organ, including colostomy bags and supplies 
directly related to colostomy care, including--
    (i) Replacement of prosthetic devices; and
    (ii) One pair of conventional eyeglasses or conventional contact 
lenses furnished after each cataract surgery during which an intraocular 
lens is inserted.
    (3) Leg, arm, back, and neck braces and artificial legs, arms, and 
eyes, including replacements if required because of a change in the 
individual's physical condition.
    (b) As a requirement for payment, CMS may determine through carrier 
instructions, or carriers may determine, that an item listed in 
paragraph (a) of this section requires a written physician order before 
delivery of the item.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 36014, Aug. 12, 1992; 
57 FR 57688, Dec. 7, 1992]

Sec. 410.37  Colorectal cancer screening tests: Conditions for and 
          limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    (1) Colorectal cancer screening tests means any of the following 
procedures furnished to an individual for the purpose of early detection 
of colorectal cancer:
    (i) Screening fecal-occult blood tests.
    (ii) Screening flexible sigmoidoscopies.
    (iii) In the case of an individual at high risk for colorectal 
cancer, screening colonoscopies.
    (iv) Screening barium enemas.

[[Page 257]]

    (v) Other tests or procedures, and modifications to tests under this 
paragraph, with such frequency and payment limits as CMS determines 
appropriate, in consultation with appropriate organizations.
    (2) Screening fecal-occult blood test means a guaiac-based test for 
peroxidase activity, testing two samples from each of three consecutive 
stools.
    (3) An individual at high risk for colorectal cancer means an 
individual with--
    (i) A close relative (sibling, parent, or child) who has had 
colorectal cancer or an adenomatous polyp;
    (ii) A family history of familial adenomatous polyposis;
    (iii) A family history of hereditary nonpolyposis colorectal cancer;
    (iv) A personal history of adenomatous polyps; or
    (v) A personal history of colorectal cancer; or
    (vi) Inflammatory bowel disease, including Crohn's Disease, and 
ulcerative colitis.
    (4) Screening barium enema means--
    (i) A screening double contrast barium enema of the entire 
colorectum (including a physician's interpretation of the results of the 
procedure); or
    (ii) In the case of an individual whose attending physician decides 
that he or she cannot tolerate a screening double contrast barium enema, 
a screening single contrast barium enema of the entire colorectum 
(including a physician's interpretation of the results of the 
procedure).
    (5) An attending physician for purposes of this provision is a 
doctor of medicine or osteopathy (as defined in section 1861(r)(1) of 
the Act) who is fully knowledgeable about the beneficiary's medical 
condition, and who would be responsible using the results of any 
examination performed in the overall management of the beneficiary's 
specific medical problem.
    (b) Condition for coverage of screening fecal-occult blood tests. 
Medicare Part B pays for a screening fecal-occult blood test if it is 
ordered in writing by the beneficiary's attending physician.
    (c) Limitations on coverage of screening fecal-occult blood tests. 
(1) Payment may not be made for a screening fecal-occult blood test 
performed for an individual under age 50.
    (2) For an individual 50 years of age or over, payment may be made 
for a screening fecal-occult blood test performed after at least 11 
months have passed following the month in which the last screening 
fecal-occult blood test was performed.
    (d) Condition for coverage of flexible sigmoidoscopy screening. 
Medicare Part B pays for a flexible sigmoidoscopy screening service if 
it is performed by a doctor of medicine or osteopathy (as defined in 
section 1861(r)(1) of the Act), or by a physician assistant, nurse 
practitioner, or clinical nurse specialist (as defined in section 
1861(aa)(5) of the Act and Secs. 410.74, 410.75, and 410.76) who is 
authorized under State law to perform the examination.
    (e) Limitations on coverage of screening flexible sigmoidoscopies. 
(1) Payment may not be made for a screening flexible sigmoidoscopy 
performed for an individual under age 50.
    (2) For an individual 50 years of age or over, except as described 
in paragraph (e)(3) of this section, payment may be made for screening 
flexible sigmoidoscopy after at least 47 months have passed following 
the month in which the last screening flexible sigmoidoscopy or, as 
provided in paragraphs (h) and (i) of this section, the last screening 
barium enema was performed.
    (3) In the case of an individual who is not at high risk for 
colorectal cancer as described in paragraph (a)(3) of this section but 
who has had a screening colonoscopy performed, payment may be made for a 
screening flexible sigmoidosocopy only after at least 119 months have 
passed following the month in which the last screening colonoscopy was 
performed.
    (f) Condition for coverage of screening colonoscopies. Medicare Part 
B pays for a screening colonoscopy if it is performed by a doctor of 
medicine or osteopathy (as defined in section 1861(r)(1) of the Act).
    (g) Limitations on coverage of screening colonoscopies. (1) 
Effective for services furnished on or after January 1, 1998 through 
June 30, 2001, payment may not be made for a screening colonoscopy for 
an individual who is

[[Page 258]]

not at high risk for colorectal cancer as described in paragraph (a)(3) 
of this section.
    (2) Effective for services furnished on or after July 1, 2001, 
except as described in paragraph (g)(4) of this section, payment may be 
made for a screening colonoscopy performed for an individual who is not 
at high risk for colorectal cancer as described in paragraph (a)(3) of 
this section, after at least 119 months have passed following the month 
in which the last screening colonoscopy was performed.
    (3) Payment may be made for a screening colonoscopy performed for an 
individual who is at high risk for colorectal cancer as described in 
paragraph (a)(3) of this section, after at least 23 months have passed 
following the month in which the last screening colonoscopy was 
performed, or, as provided in paragraphs (h) and (i) of this section, 
the last screening barium enema was performed.
    (4) In the case of an individual who is not at high risk for 
colorectal cancer as described in paragraph (a)(3) of this section but 
who has had a screening flexible sigmoidoscopy performed, payment may be 
made for a screening colonoscopy only after at least 47 months have 
passed following the month in which the last screening flexible 
sigmoidoscopy was performed.
    (h) Conditions for coverage of screening barium enemas. Medicare 
Part B pays for a screening barium enema if it is ordered in writing by 
the beneficiary's attending physician.
    (i) Limitations on coverage of screening barium enemas. (1) In the 
case of an individual age 50 or over who is not at high risk of 
colorectal cancer, payment may be made for a screening barium enema 
examination performed after at least 47 months have passed following the 
month in which the last screening barium enema or screening flexible 
sigmoidoscopy was performed.
    (2) In the case of an individual who is at high risk for colorectal 
cancer, payment may be made for a screening barium enema examination 
performed after at least 23 months have passed following the month in 
which the last screening barium enema or the last screening colonoscopy 
was performed.

[62 FR 59100, Oct. 31, 1997, as amended at 66 FR 55329, Nov. 1, 2001]

Sec. 410.38  Durable medical equipment: <STRONG>Scope</STRONG> and conditions.

    (a) Medicare Part B pays for the rental or purchase of durable 
medical equipment, including iron lungs, oxygen tents, hospital beds, 
and wheelchairs, if the equipment is used in the patient's home or in an 
institution that is used as a home.
    (b) An institution that is used as a home may not be a hospital or a 
CAH or a SNF as defined in sections 1861(e)(1), 1861(mm)(1) and 
1819(a)(1) of the Act, respectively.
    (c) Wheelchairs may include a power-operated vehicle that may be 
appropriately used as a wheelchair, but only if the vehicle--
    (1) Is determined to be necessary on the basis of the individual's 
medical and physical condition;
    (2) Meets any safety requirements specified by CMS; and
    (3) Except as provided in paragraph (c)(2) of this section, is 
ordered in writing by a specialist in physical medicine, orthopedic 
surgery, neurology, or rheumatology, the written order is furnished to 
the supplier before the delivery of the vehicle to the beneficiary, and 
the beneficiary requires the vehicle and is capable of using it.
    (4) A written prescription from the beneficiary's physician is 
acceptable for ordering a power-operated vehicle if a specialist in 
physical medicine, orthopedic surgery, neurology, or rheumatology is not 
reasonably accessible. For example, if travel to the specialist would be 
more than one day's trip from the beneficiary's home or if the 
beneficiary's medical condition precluded travel to the nearest 
available specialist, these circumstances would satisfy the ``not 
reasonably accessible'' requirement.
    (d) Medicare Part B pays for medically necessary equipment that is 
used for treatment of decubitus ulcers if--
    (1) The equipment is ordered in writing by the beneficiary's 
attending physician, or by a specialty physician on referral from the 
beneficiary's attending physician, and the written order is

[[Page 259]]

furnished to the supplier before the delivery of the equipment; and
    (2) The prescribing physician has specified in the prescription that 
he or she will be supervising the use of the equipment in connection 
with the course of treatment.
    (e) Medicare Part B pays for a medically necessary seat-lift if it--
    (1) Is ordered in writing by the beneficiary's attending physician, 
or by a specialty physician on referral from the beneficiary's attending 
physician, and the written order is furnished to the supplier before the 
delivery of the seat-lift;
    (2) Is for a beneficiary who has a diagnosis designated by CMS as 
requiring a seat-lift; and
    (3) Meets safety requirements specified by CMS.
    (f) Medicare Part B pays for transcutaneous electrical nerve 
stimulator units that are--
    (1) Determined to be medically necessary; and
    (2) Ordered in writing by the beneficiary's attending physician, or 
by a specialty physician on referral from the beneficiary's attending 
physician, and the written order is furnished to the supplier before the 
delivery of the unit to the beneficiary.
    (g) As a requirement for payment, CMS may determine through carrier 
instructions, or carriers may determine that an item of durable medical 
equipment requires a written physician order before delivery of the 
item.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 57688, Dec. 7, 1992; 58 
FR 30668, May 26, 1993]

Sec. 410.39  Prostate cancer screening tests: Conditions for and 
          limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    (1) Prostate cancer screening tests means any of the following 
procedures furnished to an individual for the purpose of early detection 
of prostate cancer:
    (i) A screening digital rectal examination.
    (ii) A screening prostate-specific antigen blood test.
    (iii) For years beginning after 2002, other procedures CMS finds 
appropriate for the purpose of early detection of prostate cancer, 
taking into account changes in technology and standards of medical 
practice, availability, effectiveness, costs, and other factors CMS 
considers appropriate.
    (2) A screening digital rectal examination means a clinical 
examination of an individual's prostate for nodules or other 
abnormalities of the prostate.
    (3) A screening prostate-specific antigen blood test means a test 
that measures the level of prostate-specific antigen in an individual's 
blood.
    (4) A physician for purposes of this provision means a doctor of 
medicine or osteopathy (as defined in section 1861(r)(1) of the Act) who 
is fully knowledgeable about the beneficiary, and who would be 
responsible for explaining the results of the screening examination or 
test.
    (5) A physician assistant, nurse practitioner, clinical nurse 
specialist, or certified nurse midwife for purposes of this provision 
means a physician assistant, nurse practitioner, clinical nurse 
specialist, or certified nurse midwife (as defined in sections 1861(aa) 
and 1861(gg) of the Act) who is fully knowledgeable about the 
beneficiary, and who would be responsible for explaining the results of 
the screening examination or test.
    (b) Condition for coverage of screening digital rectal examinations. 
Medicare Part B pays for a screening digital rectal examination if it is 
performed by the beneficiary's physician, or by the beneficiary's 
physician assistant, nurse practitioner, clinical nurse specialist, or 
certified nurse midwife as defined in paragraphs (a)(4) or (a)(5) of 
this section who is authorized to perform this service under State law.
    (c) Limitation on coverage of screening digital rectal examinations. 
(1) Payment may not be made for a screening digital rectal examination 
performed for a man age 50 or younger.
    (2) For an individual over 50 years of age, payment may be made for 
a screening digital rectal examination only if the man has not had such 
an examination paid for by Medicare during the preceding 11 months 
following the month in which his last Medicare-covered screening digital 
rectal examination was performed.

[[Page 260]]

    (d) Condition for coverage of screening prostate-specific antigen 
blood tests. Medicare Part B pays for a screening prostate-specific 
antigen blood test if it is ordered by the beneficiary's physician, or 
by the beneficiary's physician assistant, nurse practitioner, clinical 
nurse specialist, or certified nurse midwife as defined in paragraphs 
(a)(4) or (a)(5) of this section who is authorized to order this test 
under State law.
    (e) Limitation on coverage of screening prostate-specific antigen 
blood test. (1) Payment may not be made for a screening prostate-
specific antigen blood test performed for a man age 50 or younger.
    (2) For an individual over 50 years of age, payment may be made for 
a screening prostate-specific antigen blood test only if the man has not 
had such an examination paid for by Medicare during the preceding 11 
months following the month in which his last Medicare-covered screening 
prostate-specific antigen blood test was performed.

[64 FR 59440, Nov. 2, 1999, as amended at 65 FR 19331, Apr. 11, 2000]

Sec. 410.40  Coverage of ambulance services.

    (a). Basic rules. Medicare Part B covers ambulance services if the 
following conditions are met:
    (1) The supplier meets the applicable vehicle, staff, and billing 
and reporting requirements of Sec. 410.41 and the service meets the 
medical necessity and origin and destination requirements of paragraphs 
(d) and (e) of this section.
    (2) Medicare Part A payment is not made directly or indirectly for 
the services.
    (b) Levels of service. Medicare covers the following levels of 
ambulance service, which are defined in Sec. 414.605 of this chapter:
    (1) Basic life support (BLS) (emergency and nonemergency).
    (2) Advanced life support, level 1 (ALS1) (emergency and 
nonemergency).
    (3) Advanced life support, level 2 (ALS2).
    (4) Paramedic ALS intercept (PI).
    (5) Specialty care transport (SCT).
    (6) Fixed wing transport (FW).
    (7) Rotary wing transport (RW).
    (c) Paramedic ALS intercept services. Paramedic ALS intercept 
services must meet the following requirements:
    (1) Be furnished in an area that is designated as a rural area by 
any law or regulation of the State or that is located in a rural census 
tract of a metropolitan statistical area (as determined under the most 
recent Goldsmith Modification). (The Goldsmith Modification is a 
methodology to identify small towns and rural areas within large 
metropolitan counties that are isolated from central areas by distance 
or other features.)
    (2) Be furnished under contract with one or more volunteer ambulance 
services that meet the following conditions:
    (i) Are certified to furnish ambulance services as required under 
Sec. 410.41.
    (ii) Furnish services only at the BLS level.
    (iii) Be prohibited by State law from billing for any service.
    (3) Be furnished by a paramedic ALS intercept supplier that meets 
the following conditions:
    (i) Is certified to furnish ALS services as required in 
Sec. 410.41(b)(2).
    (ii) Bills all the recipients who receive ALS intercept services fro 
the entity, regardless of whether or not those recipients are Medicare 
beneficiaries.
    (d) Medical necessity requirements--(1) General rule. Medicare 
covers ambulance services, including fixed wing and rotary wing 
ambulance services, only if they are furnished to a beneficiary whose 
medical condition is such that other means of transportation are 
contraindicated. The beneficiary's condition must require both the 
ambulance transportation itself and the level of service provided in 
order for the billed service to be considered medically necessary. 
Nonemergency transportation by ambulance is appropriate if either: the 
beneficiary is bed-confined, and it is documented that the beneficiary's 
condition is such that other methods of transportation are 
contraindicated; or, if his or her medical condition, regardless of bed 
confinement, is such that transportation by ambulance is medically 
required. Thus, bed confinement is not the sole criterion in determining 
the medical necessity of ambulance transportation. It is one factor that 
is

[[Page 261]]

considered in medical necessity determinations. For a beneficiary to be 
considered bed-confined, the following criteria must be met:
    (i) The beneficiary is unable to get up from bed without assistance.
    (ii) The beneficiary is unable to ambulate.
    (iii) The beneficiary is unable to sit in a chair or wheelchair.
    (2) Special rule for nonemergency, scheduled, repetitive ambulance 
services. Medicare covers medically necessary nonemergency, scheduled, 
repetitive ambulance services if the ambulance provider or supplier, 
before furnishing the service to the beneficiary, obtains a written 
order from the beneficiary's attending physician certifying that the 
medical necessity requirements of paragraph (d)(1) of this section are 
met. The physician's order must be dated no earlier than 60 days before 
the date the service is furnished.
    (3) Special rule for nonemergency ambulance services that are either 
unscheduled or that are scheduled on a nonrepetitive basis. Medicare 
covers medically necessary nonemergency ambulance services that are 
either unscheduled or that are scheduled on a nonrepetitive basis under 
one of the following circumstances:
    (i) For a resident of a facility who is under the care of a 
physician if the ambulance provider or supplier obtains a written order 
from the beneficiary's attending physician, within 48 hours after the 
transport, certifying that the medical necessity requirements of 
paragraph (d)(1) of this section are met.
    (ii) For a beneficiary residing at home or in a facility who is not 
under the direct care of a physician. A physician certification is not 
required.
    (iii) If the ambulance provider or supplier is unable to obtain a 
signed physician certification statement from the beneficiary's 
attending physician, a signed certification statement must be obtained 
from either the physician assistant (PA), nurse practitioner (NP), 
clinical nurse specialist (CNS), registered nurse (RN), or discharge 
planner, who has personal knowledge of the beneficiary's condition at 
the time the ambulance transport is ordered or the service is furnished. 
This individual must be employed by the beneficiary's attending 
physician or by the hospital or facility where the beneficiary is being 
treated and from which the beneficiary is transported. Medicare 
regulations for PAs, NPs, and CNSs apply and all applicable State 
licensure laws apply; or,
    (iv) If the ambulance provider or supplier is unable to obtain the 
required certification within 21 calendar days following the date of the 
service, the ambulance supplier must document its attempts to obtain the 
requested certification and may then submit the claim. Acceptable 
documentation includes a signed return receipt from the U.S. Postal 
Service or other similar service that evidences that the ambulance 
supplier attempted to obtain the required signature from the 
beneficiary's attending physician or other individual named in paragraph 
(d)(3)(iii) of this section.
    (v) In all cases, the provider or supplier must keep appropriate 
documentation on file and, upon request, present it to the contractor. 
The presence of the signed certification statement or signed return 
receipt does not alone demonstrate that the ambulance transport was 
medically necessary. All other program criteria must be met in order for 
payment to be made.
    (e) Origin and destination requirements. Medicare covers the 
following ambulance transportation:
    (1) From any point of origin to the nearest hospital, CAH, or SNF 
that is capable of furnishing the required level and type of care for 
the beneficiary's illness or injury. The hospital or CAH must have 
available the type of physician or physician specialist needed to treat 
the beneficiary's condition.
    (2) From a hospital, CAH, or SNF to the beneficiary's home.
    (3) From a SNF to the nearest supplier of medically necessary 
services not available at the SNF where the beneficiary is a resident, 
including the return trip.
    (4) For a beneficiary who is receiving renal dialysis for treatment 
of ESRD, from the beneficiary's home to the nearest facility that 
furnishes renal dialysis, including the return trip.
    (f) Specific limits on coverage of ambulance services outside the 
United States. If services are furnished outside the

[[Page 262]]

United States, Medicare Part B covers ambulance transportation to a 
foreign hospital only in conjunction with the beneficiary's admission 
for medically necessary inpatient services as specified in subpart H of 
part 424 of this chapter.

[64 FR 3648, Jan. 25, 1999, as amended at 65 FR 13914, Mar. 15, 2000; 67 
FR 9132, Feb. 27, 2002]

Sec. 410.41  Requirements for ambulance suppliers.

    (a) Vehicle. A vehicle used as an ambulance must meet the following 
requirements:
    (1) Be specially designed to respond to medical emergencies or 
provide acute medical care to transport the sick and injured and comply 
with all State and local laws governing an emergency transportation 
vehicle.
    (2) Be equipped with emergency warning lights and sirens, as 
required by State or local laws.
    (3) Be equipped with telecommunications equipment as required by 
State or local law to include, at a minimum, one two-way voice radio or 
wireless telephone.
    (4) Be equipped with a stretcher, linens, emergency medical 
supplies, oxygen equipment, and other lifesaving emergency medical 
equipment as required by State or local laws.
    (b) Vehicle staff--(1) BLS vehicles. A vehicle furnishing ambulance 
services must be staffed by at least two people, one of whom must meet 
the following requirements:
    (i) Be certified as an emergency medical technician by the State or 
local authority where the services are furnished.
    (ii) Be legally authorized to operate all lifesaving and life-
sustaining equipment on board the vehicle.
    (2) ALS vehicles. In addition to meeting the vehicle staff 
requirements of paragraph (b)(1) of this section, one of the two staff 
members must be certified as a paramedic or an emergency medical 
technician, by the State or local authority where the services are being 
furnished, to perform one or more ALS services.
    (c) Billing and reporting requirements. An ambulance supplier must 
comply with the following requirements:
    (1) Bill for ambulance services using CMS-designated procedure codes 
to describe origin and destination and indicate on claims form that the 
physician certification is on file.
    (2) Upon a carrier's request, complete and return the ambulance 
supplier form designated by CMS and provide the Medicare carrier with 
documentation of compliance with emergency vehicle and staff licensure 
and certification requirements in accordance with State and local laws.
    (3) Upon a carrier's request, provide additional information and 
documentation as required.

[64 FR 3648, Jan. 25, 1999]

Sec. 410.42  Limitations on coverage of certain services furnished to 
          hospital outpatients.

    (a) General rule. Except as provided in paragraph (b) of this 
section, Medicare Part B does not pay for any item or service that is 
furnished to a hospital outpatient (as defined in Sec. 410.2) during an 
encounter (as defined in Sec. 410.2) by an entity other than the 
hospital unless the hospital has an arrangement (as defined in 
Sec. 409.3 of this chapter) with that entity to furnish that particular 
service to its patients. As used in this paragraph, the term 
``hospital'' includes a CAH.
    (b) Exception. The limitations stated in paragraph (a) of this 
section do not apply to the following services:
    (1) Physician services that meet the requirements of Sec. 415.102(a) 
of this chapter for payment on a fee schedule basis.
    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (3) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Certified nurse mid-wife services, as defined in section 
1861(gg) of the Act.
    (5) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (6) Services of an anesthetist, as defined in Sec. 410.69.
    (7) Services furnished to SNF residents as defined in Sec. 411.15(p) 
of this chapter.

[65 FR 18536, Apr. 7, 2000]

[[Page 263]]

Sec. 410.43  Partial hospitalization services: Conditions and 
          exclusions.

    (a) Partial hospitalization services are services that--
    (1) Are reasonable and necessary for the diagnosis or active 
treatment of the individual's condition;
    (2) Are reasonably expected to improve or maintain the individual's 
condition and functional level and to prevent relapse or 
hospitalization; and
    (3) Include any of the following:
    (i) Individual and group therapy with physicians or psychologists or 
other mental health professionals to the extent authorized under State 
law.
    (ii) Occupational therapy requiring the skills of a qualified 
occupational therapist.
    (iii) Services of social workers, trained psychiatric nurses, and 
other staff trained to work with psychiatric patients.
    (iv) Drugs and biologicals furnished for therapeutic purposes, 
subject to the limitations specified in Sec. 410.29.
    (v) Individualized activity therapies that are not primarily 
recreational or diversionary.
    (vi) Family counseling, the primary purpose of which is treatment of 
the individual's condition.
    (vii) Patient training and education, to the extent the training and 
educational activities are closely and clearly related to the 
individual's care and treatment.
    (viii) Diagnostic services.
    (b) The following services are separately covered and not paid as 
partial hospitalization services:
    (1) Physician services that meet the requirements of Sec. 415.102(a) 
of this chapter for payment on a fee schedule basis.
    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (3) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (5) Services furnished to SNF residents as defined in Sec. 411.15(p) 
of this chapter.

[59 FR 6577, Feb. 11, 1994, as amended at 65 FR 18536, Apr. 7, 2000]

Sec. 410.45  Rural health clinic services: <STRONG>Scope</STRONG> and conditions.

    (a) Medicare Part B pays for the following rural health clinic 
services, if they are furnished in accordance with the requirements and 
conditions specified in part 405, subpart X, and part 491 of this 
chapter:
    (1) Physicians' services.
    (2) Services and supplies furnished as an incident to physicians' 
professional services.
    (3) Nurse practitioner and physician assistant services.
    (4) Services and supplies furnished as an incident to nurse 
practitioners' or physician assistants' services.
    (5) Visiting nurse services.
    (b) Medicare pays for rural health clinic services when they are 
furnished at the clinic, at a hospital or other medical facility, or at 
the beneficiary's place of residence.

Sec. 410.46   Physician and other practitioner services furnished in or 
          at the direction of an IHS or Indian tribal hospital or 
          clinic: <STRONG>Scope</STRONG> and conditions.

    (a) Medicare Part B pays, in accordance with the physician fee 
schedule, for services furnished in or at the direction of a hospital or 
outpatient clinic (provider-based or free-standing) that is operated by 
the Indian Health Service (IHS) or by an Indian tribe or tribal 
organization (as those terms are defined in section 4 of the Indian 
Health Care Improvement Act). These services are subject to the same 
situations, terms, and conditions that would apply if the services were 
furnished in or at the direction of a hospital or clinic that is not 
operated by IHS or by an Indian tribe or tribal organization. Payments 
include health professional shortage areas incentive payments when the 
requirements for these incentive payments in Sec. 414.42 of this chapter 
are met.
    (b) Payment is not made under this section to the extent that 
Medicare otherwise pays for the same services under other provisions.
    (c) Payment is made under these provisions for the following 
services:
    (1) Services for which payment is made under the physician fee 
schedule

[[Page 264]]

in accordance with part 414 of this chapter.
    (2) Services furnished by non-physician practitioners for which 
payment under Part B is made under the physician fee schedule.
    (3) Services furnished by a physical therapist or occupational 
therapist, for which payment under Part B is made under the physician 
fee schedule.
    (d) Payments under these provisions will be paid to the IHS or 
tribal hospital or clinic.

[66 FR 55329, Nov. 1, 2001]

Sec. 410.50  Institutional dialysis services and supplies: <STRONG>Scope</STRONG> and 
          conditions.

    Medicare Part B pays for the following institutional dialysis 
services and supplies if they are furnished in approved ESRD facilities:
    (a) All services, items, supplies, and equipment necessary to 
perform dialysis and drugs medically necessary in the treatment of the 
patient for ESRD.
    (b) Routine dialysis monitoring tests (i.e., hematocrit and clotting 
time) used by the facility to monitor the patients' fluids incident to 
each dialysis treatment, when performed by qualified staff of the 
facility under the direction of a physician, as provided in 
Sec. 405.2163(b) of this chapter, even if the facility does not meet the 
conditions for coverage of services of independent laboratories in 
subpart M of part 405 of this chapter.
    (c) Routine diagnostic tests.
    (d) Epoetin (EPO) and its administration.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 43709, Sept. 4, 1991; 
59 FR 1285, Jan. 10, 1994]

Sec. 410.52  Home dialysis services, supplies, and equipment: <STRONG>Scope</STRONG> and 
          conditions.

    (a) Medicare Part B pays for the following services, supplies, and 
equipment furnished to an ESRD patient in his or her home:
    (1) Purchase or rental, installation, and maintenance of all 
dialysis equipment necessary for home dialysis, and reconditioning of 
this equipment. Dialysis equipment includes, but is not limited to, 
artificial kidney and automated peritoneal dialysis machines, and 
support equipment such as blood pumps, bubble detectors, and other alarm 
systems.
    (2) Items and supplies required for dialysis, including (but not 
limited to) dialyzers, syringes and needles, forceps, scissors, scales, 
sphygmomanometer with cuff and stethoscope, alcohol wipes, sterile 
drapes, and rubber gloves.
    (3) Home dialysis support services furnished by an approved ESRD 
facility, including periodic monitoring of the patient's home 
adaptation, emergency visits by qualified provider or facility 
personnel, any of the tests specified in paragraphs (b) through (d) of 
Sec. 410.50, personnel costs associated with the installation and 
maintenance of dialysis equipment, testing and appropriate treatment of 
water, and ordering of supplies on an ongoing basis.
    (4) On or after July 1, 1991, epoetin (EPO) for use at home by a 
home dialysis patient and, on or after January 1, 1994, by a dialysis 
patient, if it has been determined, in accordance with Sec. 405.2163 of 
this chapter, that the patient is competent to use the drug safely and 
effectively.
    (b) Home dialysis support services specified in paragraph (a)(3) of 
this section must be furnished in accordance with a written treatment 
plan that is prepared and reviewed by a team consisting of the 
individual's physician and other qualified professionals. (Section 
405.2137 of this chapter contains specific details.)

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 43709, Sept. 4, 1991; 
59 FR 26959, May 25, 1994]

Sec. 410.55  Services related to kidney donations: Conditions.

    Medicare Part B pays for medical and other health services covered 
under this subpart that are furnished in connection with a kidney 
donation--
    (a) If the kidney is intended for an individual who has end-stage 
renal disease and is entitled to Medicare <STRONG>benefits</STRONG>; and
    (b) Regardless of whether the donor is entitled to Medicare.

Sec. 410.56  Screening pelvic examinations.

    (a) Conditions for screening pelvic examinations. Medicare Part B 
pays for a

[[Page 265]]

screening pelvic examination (including a clinical breast examination) 
if it is performed by a doctor of medicine or osteopathy (as defined in 
section 1861(r)(1) of the Act), or by a certified nurse midwife (as 
defined in section 1861(gg) of the Act), or a physician assistant, nurse 
practitioner, or clinic nurse specialist (as defined in section 1861(aa) 
of the Act) who is authorized under State law to perform the 
examination.
    (b) Limits on coverage of screening pelvic examinations. The 
following limitations apply to coverage of screening pelvic examination 
services:
    (1) General rule. Except as specified in paragraphs (b)(2) and 
(b)(3) of this section, payment may be made for a pelvic examination 
performed on an asymptomatic woman only if the individual has not had a 
pelvic examination paid for by Medicare during the preceding 23 months 
following the month in which her last Medicare-covered screening pelvic 
examination was performed.
    (2) More frequent screening based on high-risk factors. Subject to 
the limitation as specified in paragraph (b)(4) of this section, payment 
may be made for a screening pelvic examination performed more frequently 
than once every 24 months if the test is performed by a physician or 
other practitioner specified in paragraph (a) of this section, and there 
is evidence that the woman is at high risk (on the basis of her medical 
history or other findings) of developing cervical cancer or vaginal 
cancer, as determined in accordance with the following risk factors:
    (i) High risk factors for cervical cancer:
    (A) Early onset of sexual activity (under 16 years of age).
    (B) Multiple sexual partners (five or more in a lifetime).
    (C) History of a sexually transmitted disease (including HIV 
infection).
    (D) Absence of three negative or any Pap smears within the previous 
7 years.
    (ii) High risk factor for vaginal cancer: DES (diethylstilbestrol)-
exposed daughters of women who took DES during pregnancy.
    (3) More frequent screening for women of childbearing age. Subject 
to the limitation as specified in paragraph (b)(4) of this section, 
payment may be made for a screening pelvic examination performed more 
frequently than once every 24 months if the test is performed by a 
physician or other practitioner as specified in paragraph (a) of this 
section for a woman of childbearing age who has had an examination that 
indicated the presence of cervical or vaginal cancer or other 
abnormality during any of the preceding 3 years. The term ``woman of 
childbearing age'' means a woman who is premenopausal, and has been 
determined by a physician, or a qualified practitioner, as specified in 
paragraph (a) of this section, to be of childbearing age, based on her 
medical history or other findings.
    (4) Limitation applicable to women at high risk and those of 
childbearing age. Payment is not made for a screening pelvic examination 
for women considered to be at high risk (under any of the criteria 
described in paragraph (b)(2) of this section), or who qualify for 
coverage under the childbearing provision (under the criteria described 
in paragraph (b)(3) of this section) more frequently than once every 11 
months after the month that the last screening pelvic examination 
covered by Medicare was performed.

[62 FR 59101, Oct. 31, 1997; 63 FR 4596, Jan. 30, 1998, as amended at 66 
FR 55329, Nov. 1, 2001]

Sec. 410.57  Pneumococcal vaccine and flu vaccine.

    (a) Medicare Part B pays for pneumococcal vaccine and its 
administration when reasonable and necessary for the prevention of 
disease, if the vaccine is ordered by a doctor of medicine or 
osteopathy.
    (b) Medicare Part B pays for the influenza virus vaccine and its 
administration.

[63 FR 35066, June 26, 1998]

Sec. 410.58  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:
    (a) The services are--

[[Page 266]]

    (1) Furnished by a physician assistant or nurse practitioner as 
defined in Sec. 491.2 of this chapter, or are incident to services 
furnished by such a practitioner; or
    (2) Furnished by a clinical psychologist as defined in Sec. 417.416 
of this chapter to an enrollee of an HMO or CMP that participates in 
Medicare under a risk-sharing contract, or are incident to those 
services.
    (b) The services are services that would be covered under Medicare 
Part B if they were furnished by a physician or as incident to a 
physician's professional services.

Sec. 410.59  Outpatient occupational therapy services: Conditions.

    (a) Basic rule. Medicare Part B pays for outpatient occupational 
therapy services if they meet the following conditions:
    (1) They are furnished to a beneficiary while he or she is under the 
care of a physician who is a doctor of medicine, osteopathy, or 
podiatric medicine.
    (2) They are furnished under a written plan of treatment that meets 
the requirements of Sec. 410.61.
    (3) They are furnished--
    (i) By a provider as defined in Sec. 489.2 of this chapter, or by 
others under arrangements with, and under the supervision of, a 
provider; or
    (ii) By or under the personal supervision of an occupational 
therapist in private practice as described in paragraph (c) of this 
section.
    (b) Outpatient occupational therapy services furnished to certain 
inpatients of a hospital or a CAH or SNF. Medicare Part B pays for 
outpatient occupational therapy services furnished to an inpatient of a 
hospital, CAH, or SNF who requires them but who has exhausted or is 
otherwise ineligible for benefit days under Medicare Part A.
    (c) Special provisions for services furnished by occupational 
therapists in private practice.
    (1) Basic qualifications. In order to qualify under Medicare as a 
supplier of outpatient occupational therapy services, each individual 
occupational therapist in private practice must meet the following 
requirements:
    (i) Be legally authorized (if applicable, licensed, certified, or 
registered) to engage in the private practice of occupational therapy by 
the State in which he or she practices, and practice only within the 
<STRONG>scope</STRONG> of his or her license, certification, or registration.
    (ii) Engage in the private practice of occupational therapy on a 
regular basis as an individual, in one of the following practice types:
    (A) An unincorporated solo practice.
    (B) A partnership or unincorporated group practice.
    (C) An unincorporated solo practice, partnership, or group practice, 
a professional corporation or other incorporated occupational therapy 
practice. Private practice does not include any individual during the 
time he or she is working as an employee of a provider.
    (iii) Bill Medicare only for services furnished in his or her 
private practice office space, or in the patient's home. A therapist's 
private practice office space refers to the location(s) where the 
practice is operated, in the State(s) where the therapist (and practice, 
if applicable) is legally authorized to furnish services, during the 
hours that the therapist engages in practice at that location. When 
services are furnished in private practice office space, that space must 
be owned, leased, or rented by the practice and used for the exclusive 
purpose of operating the practice. A patient's home does not include any 
institution that is a hospital, an CAH, or a SNF.
    (iv) Treat individuals who are patients of the practice and for whom 
the practice collects fees for the services furnished.
    (2) Supervision of occupational therapy services. Occupational 
therapy services are performed by, or under the personal supervision of, 
the occupational therapist in private practice. All services not 
performed personally by the therapist must be performed by employees of 
the practice, personally supervised by the therapist, and included in 
the fee for the therapist's services.
    (d) Excluded services. No service is included as an outpatient 
occupational therapy service if it would not be included as an inpatient 
hospital service if furnished to a hospital or CAH inpatient.

[[Page 267]]

    (e) Annual limitation on incurred expenses. (1) Amount of 
limitation. (i) In 1999, 2000, and 2001, no more than $1,500 of 
allowable charges incurred in a calendar year for outpatient 
occupational therapy services are recognized incurred expenses.
    (ii) In 2002 and thereafter, the limitation is determined by 
increasing the limitation in effect in the previous calendar year by the 
increase in the Medicare Economic Index for the current year.
    (2) For purposes of applying the limitation, outpatient occupational 
therapy includes:
    (i) Except as provided in paragraph (e)(3) of this section, 
outpatient occupational therapy services furnished under this section;
    (ii) Outpatient occupational therapy services furnished by a 
comprehensive outpatient rehabilitation facility;
    (iii) Outpatient occupational therapy services furnished by a 
physician or incident to a physician's service;
    (iv) Outpatient occupational therapy services furnished by a nurse 
practitioner, clinical nurse specialist, or physician assistant or 
incident to their services.
    (3) For purposes of applying the limitation, outpatient occupational 
therapy services excludes services furnished by a hospital directly or 
under arrangements.

[63 FR 58906, Nov. 2, 1998]

Sec. 410.60  Outpatient physical therapy services: Conditions.

    (a) Basic rule. Medicare Part B pays for outpatient physical therapy 
services if they meet the following conditions:
    (1) They are furnished to a beneficiary while he or she is under the 
care of a physician who is a doctor of medicine, osteopathy, or 
podiatric medicine.
    (2) They are furnished under a written plan of treatment that meets 
the requirements of Sec. 410.61.
    (3) They are furnished--
    (i) By a provider as defined in Sec. 489.2 of this chapter, or by 
others under arrangements with, and under the supervision of, a 
provider; or
    (ii) By or under the personal supervision of a physical therapist in 
private practice as described in paragraph (c) of this section.
    (b) Outpatient physical therapy services furnished to certain 
inpatients of a hospital or a CAH or SNF. Medicare Part B pays for 
outpatient physical therapy services furnished to an inpatient of a 
hospital, CAH, or SNF who requires them but who has exhausted or is 
otherwise +ineligible for benefit days under Medicare Part A.
    (c) Special provisions for services furnished by physical therapists 
in private practice. (1) Basic qualifications. In order to qualify under 
Medicare as a supplier of outpatient physical therapy services, each 
individual physical therapist in private practice must meet the 
following requirements:
    (i) Be legally authorized (if applicable, licensed, certified, or 
registered) to engage in the private practice of physical therapy by the 
State in which he or she practices, and practice only within the <STRONG>scope</STRONG> 
of his or her license, certification, or registration.
    (ii) Engage in the private practice of physical therapy on a regular 
basis as an individual, in one of the following practice types:
    (A) An unincorporated solo practice.
    (B) An unincorporated partnership or unincorporated group practice.
    (C) An unincorporated solo practice, partnership, or group practice, 
or a professional corporation or other incorporated physical therapy 
practice. Private practice does not include any individual during the 
time he or she is working as an employee of a provider.
    (iii) Bill Medicare only for services furnished in his or her 
private practice office space, or in the patient's home. A therapist's 
private practice office space refers to the location(s) where the 
practice is operated, in the State(s) where the therapist (and practice, 
if applicable) is legally authorized to furnish services, during the 
hours that the therapist engages in practice at that location. When 
services are furnished in private practice office space, that space must 
be owned, leased, or rented by the practice and used for the exclusive 
purpose of operating the practice. A patient's home does not include any 
institution that is a hospital, a CAH, or a SNF.

[[Page 268]]

    (iv) Treat individuals who are patients of the practice and for whom 
the practice collects fees for the services furnished.
    (2) Supervision of physical therapy services. Physical therapy 
services are performed by, or under the personal supervision of, the 
physical therapist in private practice. All services not performed 
personally by the therapist must be performed by employees of the 
practice, personally supervised by the therapist, and included in the 
fee for the therapist's services.
    (d) Excluded services. No service is included as an outpatient 
physical therapy service if it would not be included as an inpatient 
hospital service if furnished to a hospital or CAH inpatient.
    (e) Annual limitation on incurred expenses. (1) Amount of 
limitation. (i) In 1999, 2000, and 2001, no more than $1,500 of 
allowable charges incurred in a calendar year for outpatient physical 
therapy services are recognized incurred expenses.
    (ii) In 2002 and thereafter, the limitation shall be determined by 
increasing the limitation in effect in the previous calendar year by the 
increase in the Medicare Economic Index for the current year.
    (2) For purposes of applying the limitation, outpatient physical 
therapy includes:
    (i) Except as provided in paragraph (e)(3) of this section, 
outpatient physical therapy services furnished under this section;
    (ii) Except as provided in paragraph (e)(3) of this section 
outpatient speech-language pathology services furnished under 
Sec. 410.62;
    (iii) Outpatient physical therapy and speech-language pathology 
services furnished by a comprehensive outpatient rehabilitation 
facility;
    (iv) Outpatient physical therapy and speech-language pathology 
services furnished by a physician or incident to a physician's service;
    (v) Outpatient physical therapy and speech-language pathology 
services furnished by a nurse practitioner, clinical nurse specialist, 
or physician assistant or incident to their services.
    (3) For purposes of applying the limitation, outpatient physical 
therapy excludes services furnished by a hospital or CAH directly or 
under arrangements.

[63 FR 58906, Nov. 2, 1998]

Sec. 410.61  Plan of treatment requirements for outpatient 
          rehabilitation services.

    (a) Basic requirement. Outpatient rehabilitation services (including 
services furnished by a qualified physical or occupational therapist in 
private practice), must be furnished under a written plan of treatment 
that meets the requirements of paragraphs (b) through (e) of this 
section.
    (b) Establishment of the plan. The plan is established before 
treatment is begun by one of the following:
    (1) A physician.
    (2) A physical therapist who furnishes the physical therapy 
services.
    (3) A speech-language pathologist who furnishes the speech-language 
pathology services.
    (4) An occupational therapist who furnishes the occupational therapy 
services.
    (5) A nurse practitioner, a clinical nurse specialist, or a 
physician assistant.
    (c) Content of the plan. The plan prescribes the type, amount, 
frequency, and duration of the physical therapy, occupational therapy, 
or speech-language pathology services to be furnished to the individual, 
and indicates the diagnosis and anticipated goals.
    (d) Changes in the plan. Any changes in the plan--
    (1) Are made in writing and signed by one of the following:
    (i) The physician.
    (ii) The physical therapist who furnishes the physical therapy 
services.
    (iii) The occupational therapist who furnishes the physical therapy 
services.
    (iv) The speech-language pathologist who furnishes the speech-
language pathology services.
    (v) A registered professional nurse or a staff physician, in 
accordance with oral orders from the physician, physical therapist, 
occupational therapist, or speech-language pathologist who furnishes the 
services.
    (vi) A nurse practitioner, a clinical nurse specialist, or a 
physician assistant.

[[Page 269]]

    (2) The changes are incorporated in the plan immediately.
    (e) Review of the plan. (1) The physician reviews the plan as often 
as the individual's condition requires, but at least every 30 days.
    (2) Each review is dated and signed by the physician who performs 
it.

[53 FR 6638, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988, as amended at 54 
FR 38680, Sept. 20, 1989; 54 FR 46614, Nov. 6, 1989. Redesignated at 56 
FR 8854, Mar. 1, 1991; 56 FR 23022, May 20, 1991; 63 FR 58907, Nov. 2, 
1998]

Sec. 410.62  Outpatient speech-language pathology services: Conditions 
          and exclusions.

    (a) Basic rule. Medicare Part B pays for outpatient speech pathology 
services if they meet the following conditions:
    (1) They are furnished to a beneficiary while he or she is under the 
care of a physician who is a doctor of medicine or osteopathy.
    (2) They are furnished under a written plan of treatment that--
    (i) Is established by a physician or, effective January 1, 1982, by 
either a physician or the speech pathologist who will provide the 
services to the particular individual;
    (ii) Is periodically reviewed by a physician; and
    (iii) Meets the requirements of Sec. 410.63.
    (3) They are furnished by a provider as defined in Sec. 489.2 of 
this chapter or by others under arrangements with, or under the 
supervision of, a provider.
    (b) Outpatient speech pathology services to certain inpatients of a 
hospital, CAH, or SNF. Medicare Part B pays for outpatient speech 
pathology services furnished to an inpatient of a hospital, CAH, or SNF 
who requires them but has exhausted or is otherwise ineligible for 
benefit days under Medicare Part A.
    (c) Excluded services. No service is included as an outpatient 
speech pathology service if it would not be included as an inpatient 
hospital service if furnished to a hospital or CAH inpatient.
    (d) Limitation. After 1998, outpatient speech-language pathology 
services are subject to the limitation in Sec. 410.60(e).

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 56 
FR 8852, Mar. 1, 1991; 56 FR 23022, May 20. 1991; 58 FR 30668, May 26, 
1993; 63 FR 58907, Nov. 2, 1998]

Sec. 410.63  Hepatitis B vaccine and blood clotting factors: Conditions.

    Notwithstanding the exclusion from coverage of vaccines (see 
Sec. 405.310 of this chapter) and self-administered drugs (see 
Sec. 410.29), the following services are included as medical and other 
health services covered under Sec. 410.10, subject to the specified 
conditions:
    (a) Hepatitis B vaccine: Conditions. Effective September 1, 1984, 
hepatitis B vaccinations that are reasonable and necessary for the 
prevention of illness for those individuals who are at high or 
intermediate risk of contracting hepatitis B as listed below:
    (1) High risk groups. (i) End-Stage Renal Disease (ESRD) patients;
    (ii) Hemophiliacs who receive Factor VIII or IX concentrates;
    (iii) Clients of institutions for the mentally retarded;
    (iv) Persons who live in the same household as a hepatitis B 
carrier;
    (v) Homosexual men;
    (vi) Illicit injectable drug abusers; and
    (vii) Pacific Islanders (that is, those Medicare beneficiaries who 
reside on Pacific islands under U.S. jurisdiction, other than residents 
of Hawaii).
    (2) Intermediate risk groups. (i) Staff in institutions for the 
mentally retarded and classroom employees who work with mentally 
retarded persons;
    (ii) Workers in health care professions who have frequent contact 
with blood or blood-derived body fluids during routine work (including 
workers who work outside of a hospital and have frequent contact with 
blood or other infectious secretions); and
    (iii) Heterosexually active persons with multiple sexual partners 
(that is, those Medicare beneficiaries who have had at least two 
documented episodes of sexually transmitted diseases within the 
preceding 5 years).

[[Page 270]]

    (3) Exception. Individuals described in paragraphs (a) (1) and (2) 
of this section are not considered at high or intermediate risk of 
contracting hepatitis B if they have undergone a prevaccination 
screening and have been found to be currently positive for antibodies to 
hepatitis B.
    (b) Blood clotting factors. Effective July 18, 1984, blood clotting 
factors to control bleeding for hemophilia patients competent to use 
these factors without medical or other supervision, and items related to 
the administration of those factors. The amount of clotting factors 
covered under this provision is determined by the carrier based on the 
historical utilization pattern or profile developed by the carrier for 
each patient, and based on consideration of the need for a reasonable 
reserve supply to be kept in the home in the event of emergency or 
unforeseen circumstance.

[55 FR 22790, Jun. 4, 1990; 55 FR 31186, Aug. 1, 1990]

Sec. 410.66  Emergency outpatient services furnished by a 
          nonparticipating hospital and services furnished in Mexico or 
          Canada.

    Conditions for payment of emergency outpatient services furnished by 
a nonparticipating U.S. hospital and for services furnished in Mexico or 
Canada are set forth in subparts G and H of part 424 of this chapter.

[53 FR 6634, Mar. 1, 1988; 53 FR 12945, Apr. 20, 1988]

Sec. 410.68  Antigens: <STRONG>Scope</STRONG> and conditions.

    Medicare Part B pays for--
    (a) Antigens that are furnished as services incident to a 
physician's professional services; or
    (b) A supply of antigen sufficient for not more than 12 months that 
is--
    (1) Prepared for a patient by a doctor of medicine or osteopathy who 
has examined the patient and developed a plan of treatment including 
dosage levels; and
    (2) Administered--
    (i) In accord with the plan of treatment developed by the doctor of 
medicine or osteopathy who prepared the antigen; and
    (ii) By a doctor of medicine or osteopathy or by a properly 
instructed person under the supervision of a doctor of medicine or 
osteopathy.

[54 FR 4026, Jan. 27, 1989, as amended at 65 FR 65440, Nov. 1, 2000]

Sec. 410.69  Services of a certified registered nurse anesthetist or an 
          anesthesiologist's assistant: Basic rule and definitions.

    (a) Basic rule. Medicare Part B pays for anesthesia services and 
related care furnished by a certified registered nurse anesthetist or an 
anesthesiologist's assistant who is legally authorized to perform the 
services by the State in which the services are furnished.
    (b) Definitions. For purposes of this part--
    Anesthesiologist's assistant means a person who--
    (1) Works under the direction of an anesthesiologist;
    (2) Is in compliance with all applicable requirements of State law, 
including any licensure requirements the State imposes on nonphysician 
anesthetists; and
    (3) Is a graduate of a medical school-based anesthesiologist's 
assistant educational program that--
    (A) Is accredited by the Committee on Allied Health Education and 
Accreditation; and
    (B) Includes approximately two years of specialized basic science 
and clinical education in anesthesia at a level that builds on a 
premedical undergraduate science background.
    Anesthetist includes both an anesthesiologist's assistant and a 
certified registered nurse anesthetist.
    Certified registered nurse anesthetist means a registered nurse who:
    (1) Is licensed as a registered professional nurse by the State in 
which the nurse practices;
    (2) Meets any licensure requirements the State imposes with respect 
to non-physician anesthetists;
    (3) Has graduated from a nurse anesthesia educational program that 
meets the standards of the Council on Accreditation of Nurse Anesthesia 
Programs, or such other accreditation organization as may be designated 
by the Secretary; and

[[Page 271]]

    (4) Meets the following criteria:
    (i) Has passed a certification examination of the Council on 
Certification of Nurse Anesthetists, the Council on Recertification of 
Nurse Anesthetists, or any other certification organization that may be 
designated by the Secretary; or
    (ii) Is a graduate of a program described in paragraph (3) of this 
definition and within 24 months after that graduation meets the 
requirements of paragraph (4)(i) of this definition.

[57 FR 33896, July 31, 1992]

Sec. 410.71  Clinical psychologist services and services and supplies 
          incident to clinical psychologist services.

    (a) Included services. (1) Medicare Part B covers services furnished 
by a clinical psychologist, who meets the requirements specified in 
paragraph (d) of this section, that are within the <STRONG>scope</STRONG> of his or her 
State license, if the services would be covered if furnished by a 
physician or as an incident to a physician's services.
    (2) Medicare Part B covers services and supplies furnished as an 
incident to the services of a clinical psychologist if the following 
requirements are met:
    (i) The services and supplies would be covered if furnished by a 
physician or as an incident to a physician's services.
    (ii) The services or supplies are of the type that are commonly 
furnished in a physician's or clinical psychologist's office and are 
either furnished without charge or are included in the physician's or 
clinical psychologist's bill.
    (iii) The services are an integral, although incidental, part of the 
professional services performed by the clinical psychologist.
    (iv) The services are performed under the direct supervision of the 
clinical psychologist. For example, when services are performed in the 
clinical psychologist's office, the clinical psychologist must be 
present in the office suite and immediately available to provide 
assistance and direction throughout the time the service is being 
performed.
    (v) The individual performing the service must be an employee of 
either the clinical psychologist or the legal entity that employs the 
supervising clinical psychologist, under the common law control test of 
the Act as more fully set forth in 20 CFR 404.1007.
    (b) Application of mental health treatment limitation. The treatment 
services of a clinical psychologist and services and supplies furnished 
as an incident to those services are subject to the limitation on 
payment for outpatient mental health treatment services set forth in 
Sec. 410.155.
    (c) Payment for consultations. A clinical psychologist or an 
attending or primary care physician may not bill Medicare or the 
beneficiary for the consultation that is required under paragraph (e) of 
this section.
    (d) Qualifications. For purposes of this subpart, a clinical 
psychologist is an individual who--
    (1) Holds a doctoral degree in psychology; and
    (2) Is licensed or certified, on the basis of the doctoral degree in 
psychology, by the State in which he or she practices, at the 
independent practice level of psychology to furnish diagnostic, 
assessment, preventive, and therapeutic services directly to 
individuals.
    (e) Agreement to consult. A clinical psychologist who bills Medicare 
Part B must agree to meet the requirements of paragraphs (e)(1) through 
(e)(3) of this section. The clinical psychologist's signature on a 
Medicare provider/supplier enrollment form indicates his or her 
agreement.
    (1) Unless the beneficiary's primary care or attending physician has 
referred the beneficiary to the clinical psychologist, to inform the 
beneficiary that it is desirable for the clinical psychologist to 
consult with the beneficiary's attending or primary care physician (if 
the beneficiary has such a physician) to consider any conditions 
contributing to the beneficiary's symptoms.
    (2) If the beneficiary assents to the consultation, in accordance 
with accepted professional ethical norms and taking into consideration 
patient confidentiality--
    (i) To attempt, within a reasonable time after receiving the 
consent, to consult with the physician; and
    (ii) If attempts to consult directly with the physician are not 
successful,

[[Page 272]]

to notify the physician, within a reasonable time, that he or she is 
furnishing services to the beneficiary.
    (3) Unless the primary care or attending physician referred the 
beneficiary to the clinical psychologist, to document, in the 
beneficiary's medical record, the date the patient consented or declined 
consent to consultation, the date of consultation, or, if attempts to 
consult did not succeed, the date and manner of notification to the 
physician.

[63 FR 20128, Apr. 23, 1998]

Sec. 410.73  Clinical social worker services.

    (a) Definition: clinical social worker. For purposes of this part, a 
clinical social worker is defined as an individual who--
    (1) Possesses a master's or doctor's degree in social work;
    (2) After obtaining the degree, has performed at least 2 years of 
supervised clinical social work; and
    (3) Either is licensed or certified as a clinical social worker by 
the State in which the services are performed or, in the case of an 
individual in a State that does not provide for licensure or 
certification as a clinical social worker--
    (i) Is licensed or certified at the highest level of practice 
provided by the laws of the State in which the services are performed; 
and
    (ii) Has completed at least 2 years or 3,000 hours of post master's 
degree supervised clinical social work practice under the supervision of 
a master's degree level social worker in an appropriate setting such as 
a hospital, SNF, or clinic.
    (b) Covered clinical social worker services. Medicare Part B covers 
clinical social worker services.
    (1) Definition. ``Clinical social worker services'' means, except as 
specified in paragraph (b)(2) of this section, the services of a 
clinical social worker furnished for the diagnosis and treatment of 
mental illness that the clinical social worker is legally authorized to 
perform under State law (or the State regulatory mechanism provided by 
State law) of the State in which the services are performed. The 
services must be of a type that would be covered if they were furnished 
by a physician or as an incident to a physician's professional service 
and must meet the requirements of this section.
    (2) Exception. The following services are not clinical social worker 
services for purposes of billing Medicare Part B:
    (i) Services furnished by a clinical social worker to an inpatient 
of a Medicare-participating hospital.
    (ii) Services furnished by a clinical social worker to an inpatient 
of a Medicare-participating SNF.
    (iii) Services furnished by a clinical social worker to a patient in 
a Medicare-participating dialysis facility if the services are those 
required by the conditions for coverage for ESRD facilities under 
Sec. 405.2163 of this chapter.
    (c) Agreement to consult. A clinical social worker must comply with 
the consultation requirements set forth at Sec. 410.71(f) (reading 
``clinical psychologist'' as ``clinical social worker'').
    (d) Prohibited billing. (1) A clinical social worker may not bill 
Medicare for the services specified in paragraph (b)(2) of this section.
    (2) A clinical social worker or an attending or primary care 
physician may not bill Medicare or the beneficiary for the consultation 
that is required under paragraph (c) of this section.

[63 FR 20128, Apr. 23, 1998]

Sec. 410.74  Physician assistants' services.

    (a) Basic rule. Medicare Part B covers physician assistants' 
services only if the following conditions are met:
    (1) The services would be covered as physicians' services if 
furnished by a physician (a doctor of medicine or osteopathy, as set 
forth in section 1861(r)(1) of the Act).
    (2) The physician assistant--
    (i) Meets the qualifications set forth in paragraph (c) of this 
section;
    (ii) Is legally authorized to perform the services in the State in 
which they are performed;
    (iii) Performs services that are not otherwise precluded from 
coverage because of a statutory exclusion;
    (iv) Performs the services under the general supervision of a 
physician (The supervising physician need not be physically present when 
the physician assistant is performing the services unless required by 
State law; however,

[[Page 273]]

the supervising physician must be immediately available to the physician 
assistant for consultation.);
    (v) Furnishes services that are billed by the employer of a 
physician assistant; and
    (vi) Performs the services--
    (A) In all settings in either rural and urban areas; or
    (B) As an assistant at surgery.
    (b) Services and supplies furnished incident to a physician 
assistant's services. Medicare covers services and supplies (including 
drugs and biologicals that cannot be self-administered) that are 
furnished incident to the physician assistant's services described in 
paragraph (a) of this section. These services and supplies are covered 
only if they--
    (1) Would be covered if furnished by a physician or as incident to 
the professional services of a physician;
    (2) Are the type that are commonly furnished in a physician's office 
and are either furnished without charge or are included in the bill for 
the physician assistants' services;
    (3) Are, although incidental, an integral part of the professional 
service performed by the physician;
    (4) Are performed under the direct supervision of the physician 
assistant (that is, the physician assistant is physically present and 
immediately available); and
    (5) Are performed by the employee of a physician assistant or an 
entity that employs both the physician assistant and the person 
providing the services.
    (c) Qualifications. For Medicare Part B coverage of his or her 
services, a physician assistant must meet all of the following 
conditions:
    (1) Have graduated from a physician assistant educational program 
that is accredited by the Commission on Accreditation of Allied Health 
Education Programs; or
    (2) Have passed the national certification examination that is 
administered by the National Commission on Certification of Physician 
Assistants; and
    (3) Be licensed by the State to practice as a physician assistant.
    (d) Professional services. Physician assistants can be paid for 
professional services only if the services have been professionally 
performed by them and no facility or other provider charges for the 
service or is paid any amount for the furnishing of those professional 
services.
    (1) Supervision of other nonphysician staff by a physician assistant 
does not constitute personal performance of a professional service by 
the physician assistant.
    (2) The services are provided on an assignment-related basis, and 
the physician assistant may not charge a beneficiary for a service not 
payable under this provision. If a beneficiary has made payment for a 
service, the physician assistant must make the appropriate refund to the 
beneficiary.

[63 FR 58907, Nov. 2, 1998; 64 FR 25457, May 12, 1999]

Sec. 410.75  Nurse practitioners' services.

    (a) Definition. As used in this section, the term ``physician'' 
means a doctor of medicine or osteopathy, as set forth in section 
1861(r)(1) of the Act.
    (b) Qualifications. For Medicare Part B coverage of his or her 
services, a nurse practitioner must--(1)(i) Be a registered professional 
nurse who is authorized by the State in which the services are furnished 
to practice as a nurse practitioner in accordance with State law; and
    (ii) Be certified as a nurse practitioner by a recognized national 
certifying body that has established standards for nurse practitioners; 
or
    (2) Be a registered professional nurse who is authorized by the 
State in which the services are furnished to practice as a nurse 
practitioner in accordance with State law and have been granted a 
Medicare billing number as a nurse practitioner by December 31, 2000; or
    (3) Be a nurse practitioner who on or after January 1, 2001, applies 
for a Medicare billing number for the first time and meets the standards 
for nurse practitioners in paragraphs (b)(1)(i) and (b)(1)(ii) of this 
section; or
    (4) Be a nurse practitioner who on or after January 1, 2003, applies 
for a Medicare billing number for the first time and possesses a 
master's degree in nursing and meets the standards for nurse 
practitioners in paragraphs (b)(1)(i) and (b)(1)(ii) of this section.

[[Page 274]]

    (c) Services. Medicare Part B covers nurse practitioners' services 
in all settings in both rural and urban areas, only if the services 
would be covered if furnished by a physician and the nurse practitioner-
-
    (1) Is legally authorized to perform them in the State in which they 
are performed;
    (2) Is not performing services that are otherwise excluded from 
coverage because of one of the statutory exclusions; and
    (3) Performs them while working in collaboration with a physician.
    (i) Collaboration is a process in which a nurse practitioner works 
with one or more physicians to deliver health care services within the 
<STRONG>scope</STRONG> of the practitioner's expertise, with medical direction and 
appropriate supervision as provided for in jointly developed guidelines 
or other mechanisms as provided by the law of the State in which the 
services are performed.
    (ii) In the absence of State law governing collaboration, 
collaboration is a process in which a nurse practitioner has a 
relationship with one or more physicians to deliver health care 
services. Such collaboration is to be evidenced by nurse practitioners 
documenting the nurse practitioners' <STRONG>scope</STRONG> of practice and indicating 
the relationships that they have with physicians to deal with issues 
outside their <STRONG>scope</STRONG> of practice. Nurse practitioners must document this 
collaborative process with physicians.
    (iii) The collaborating physician does not need to be present with 
the nurse practitioner when the services are furnished or to make an 
independent evaluation of each patient who is seen by the nurse 
practitioner.
    (d) Services and supplies incident to a nurse practitioners' 
services. Medicare Part B covers services and supplies (including drugs 
and biologicals that cannot be self-administered) incident to a nurse 
practitioner's services that meet the requirements in paragraph (c) of 
this section. These services and supplies are covered only if they--
    (1) Would be covered if furnished by a physician or as incident to 
the professional services of a physician;
    (2) Are of the type that are commonly furnished in a physician's 
office and are either furnished without charge or are included in the 
bill for the nurse practitioner's services;
    (3) Although incidental, are an integral part of the professional 
service performed by the nurse practitioner; and
    (4) Are performed under the direct supervision of the nurse 
practitioner (that is, the nurse practitioner must be physically present 
and immediately available).
    (e) Professional services. Nurse practitioners can be paid for 
professional services only when the services have been personally 
performed by them and no facility or other provider charges, or is paid, 
any amount for the furnishing of the professional services.
    (1) Supervision of other nonphysician staff by a nurse practitioner 
does not constitute personal performance of a professional service by a 
nurse practitioner.
    (2) The services are provided on an assignment-related basis, and a 
nurse practitioner may not charge a beneficiary for a service not 
payable under this provision. If a beneficiary has made payment for a 
service, the nurse practitioner must make the appropriate refund to the 
beneficiary.

[63 FR 58908, Nov. 2, 1998; 64 FR 25457, May 12, 1999, as amended at 64 
FR 59440, Nov. 2, 1999]

Sec. 410.76  Clinical nurse specialists' services.

    (a) Definition. As used in this section, the term ``physician'' 
means a doctor of medicine or osteopathy, as set forth in section 
1861(r)(1) of the Act.
    (b) Qualifications. For Medicare Part B coverage of his or her 
services, a clinical nurse specialist must--
    (1) Be a registered nurse who is currently licensed to practice in 
the State where he or she practices and be authorized to perform the 
services of a clinical nurse specialist in accordance with State law;
    (2) Have a master's degree in a defined clinical area of nursing 
from an accredited educational institution; and
    (3) Be certified as a clinical nurse specialist by the American 
Nurses Credentialing Center.
    (c) Services. Medicare Part B covers clinical nurse specialists' 
services in all settings in both rural and urban

[[Page 275]]

areas only if the services would be covered if furnished by a physician 
and the clinical nurse specialist--
    (1) Is legally authorized to perform them in the State in which they 
are performed;
    (2) Is not performing services that are otherwise excluded from 
coverage by one of the statutory exclusions; and
    (3) Performs them while working in collaboration with a physician.
    (i) Collaboration is a process in which a clinical nurse specialist 
works with one or more physicians to deliver health care services within 
the <STRONG>scope</STRONG> of the practitioner's expertise, with medical direction and 
appropriate supervision as provided for in jointly developed guidelines 
or other mechanisms as provided by the law of the State in which the 
services are performed.
    (ii) In the absence of State law governing collaboration, 
collaboration is a process in which a clinical nurse specialist has a 
relationship with one or more physicians to deliver health care 
services. Such collaboration is to be evidenced by clinical nurse 
specialists documenting the clinical nurse specialists' <STRONG>scope</STRONG> of 
practice and indicating the relationships that they have with physicians 
to deal with issues outside their <STRONG>scope</STRONG> of practice. Clinical nurse 
specialists must document this collaborative process with physicians.
    (iii) The collaborating physician does not need to be present with 
the clinical nurse specialist when the services are furnished, or to 
make an independent evaluation of each patient who is seen by the 
clinical nurse specialist.
    (d) Services and supplies furnished incident to clinical nurse 
specialists' services. Medicare Part B covers services and supplies 
(including drugs and biologicals that cannot be self-administered) 
incident to a clinical nurse specialist's services that meet the 
requirements in paragraph (c) of this section. These services and 
supplies are covered only if they--
    (1) Would be covered if furnished by a physician or as incident to 
the professional services of a physician;
    (2) Are of the type that are commonly furnished in a physician's 
office and are either furnished without charge or are included in the 
bill for the clinical nurse specialist's services;
    (3) Although incidental, are an integral part of the professional 
service performed by the clinical nurse specialist; and
    (4) Are performed under the direct supervision of the clinical nurse 
specialist (that is, the clinical nurse specialist must be physically 
present and immediately available).
    (e) Professional services. Clinical nurse specialists can be paid 
for professional services only when the services have been personally 
performed by them and no facility or other provider charges, or is paid, 
any amount for the furnishing of the professional services.
    (1) Supervision of other nonphysician staff by clinical nurse 
specialists does not constitute personal performance of a professional 
service by clinical nurse specialists.
    (2) The services are provided on an assignment-related basis, and a 
clinical nurse specialist may not charge a beneficiary for a service not 
payable under this provision. If a beneficiary has made payment for a 
service, the clinical nurse specialist must make the appropriate refund 
to the beneficiary.

[63 FR 58908, Nov. 2, 1998]

Sec. 410.77  Certified nurse-midwives' services: Qualifications and 
          conditions.

    (a) Qualifications. For Medicare coverage of his or her services, a 
certified nurse-midwife must:
    (1) Be a registered nurse who is legally authorized to practice as a 
nurse-midwife in the State where services are performed;
    (2) Have successfully completed a program of study and clinical 
experience for nurse-midwives that is accredited by an accrediting body 
approved by the U.S. Department of Education; and
    (3) Be certified as a nurse-midwife by the American College of 
Nurse-Midwives or the American College of Nurse-Midwives Certification 
Council.
    (b) Services. A certified nurse-midwife's services are services 
furnished by a certified nurse-midwife and services and supplies 
furnished as an incident to the certified nurse-midwife's services that-
-
    (1) Are within the <STRONG>scope</STRONG> of practice authorized by the law of the 
State in

[[Page 276]]

which they are furnished and would otherwise be covered if furnished by 
a physician or as an incident to a physician's service; and
    (2) Unless required by State law, are provided without regard to 
whether the certified nurse-midwife is under the supervision of, or 
associated with, a physician or other health care provider.
    (c) Incident to services: Basic rule. Medicare covers services and 
supplies furnished incident to the services of a certified nurse-
midwife, including drugs and biologicals that cannot be self-
administered, if the services and supplies meet the following 
conditions:
    (1) They would be covered if furnished by a physician or as incident 
to the professional services of a physician.
    (2) They are of the type that are commonly furnished in a 
physician's office and are either furnished without charge or are 
included in the bill for the certified nurse-midwife's services.
    (3) Although incidental, they are an integral part of the 
professional service performed by the certified nurse-midwife.
    (4) They are furnished under the direct supervision of a certified 
nurse-midwife (that is, the midwife is physically present and 
immediately available).
    (d) Professional services. A nurse-midwife can be paid for 
professional services only when the services have been performed 
personally by the nurse-midwife.
    (1) Supervision of other nonphysician staff by a nurse-midwife does 
not constitute personal performance of a professional service by the 
nurse-midwife.
    (2) The service is provided on an assignment-related basis, and a 
nurse-midwife may not charge a beneficiary for a service not payable 
under this provision. If the beneficiary has made payment for a service, 
the nurse-midwife must make the appropriate refund to the beneficiary.
    (3) A nurse-midwife may provide services that he or she is legally 
authorized to perform under State law as a nurse-midwife, if the 
services would otherwise be covered by the Medicare program when 
furnished by a physician or incident to a physicians' professional 
services.

[63 FR 58909, Nov. 2, 1998]

Sec. 410.78  Office and other outpatient visits, consultation, 
          individual psychotherapy and pharmacologic management via an 
          interactive telecommunications system.

    (a) Definitions. For the purposes of this section the following 
definitions apply:
    (1) Asynchronous store and forward technologies means the 
transmission of a patient's medical information from an originating site 
to the physician or practitioner at the distant site. The physician or 
practitioner at the distant site can review the medical case without the 
patient being present. An asynchronous telecommunications system in 
single media format does not include telephone calls, images transmitted 
via facsimile machines and text messages without visualization of the 
patient (electronic mail). Photographs visualized by a 
telecommunications system must be specific to the patient's medical 
condition and adequate for furnishing or confirming a diagnosis and or 
treatment plan. Dermatological photographs, for example, a photograph of 
a skin lesion, may be considered to meet the requirement of a single 
media format under this provision.
    (2) Distant site means the site at which the physician or 
practitioner delivering the service is located at the time the service 
is provided via a telecommunications system.
    (3) Interactive telecommunications system means multimedia 
communications equipment that includes, at a minimum, audio and video 
equipment permitting two-way, real-time interactive communication 
between the patient and distant site physician or practitioner. 
Telephones, facsimile machines, and electronic mail systems do not meet 
the definition of an interactive telecommunications system.
    (4) Originating site means, for purposes of a consultation, office 
or other outpatient visit, individual psychotherapy, or pharmacologic 
management via an interactive telecommunications system, the location of 
an eligible Medicare beneficiary at the time the service being furnished 
via a telecommunications system occurs. For asynchronous store and 
forward telecommunications technologies, the only

[[Page 277]]

originating sites are Federal telemedicine demonstration programs 
conducted in Alaska or Hawaii.
    (b) General rule. Medicare Part B pays for office and other 
outpatient visits, professional consultation, individual psychotherapy, 
and pharmacologic management furnished by means of an interactive 
telecommunications system if the following conditions are met:
    (1) The physician or practitioner at the distant site must be 
licensed to provide the service under State law. When the physician or 
practitioner at the distant site is licensed under State law to provide 
a covered telehealth service (that is, professional consultations, 
office and other outpatient visits, individual psychotherapy, and 
pharmacologic management), he or she may bill for, and receive payment 
for, this service when delivered via a telecommunications system.
    (2) The practitioner at the distant site is one of the following:
    (i) A physician as described in Sec. 410.20.
    (ii) A physician assistant as described Sec. 410.74.
    (iii) A nurse practitioner as described in Sec. 410.75.
    (iv) A clinical nurse specialist as described in Sec. 410.76.
    (v) A nurse-midwife as described in Sec. 410.77.
    (vi) A clinical psychologist as described in Sec. 410.71.
    (vii) A clinical social worker as described in Sec. 410.73.
    (3) The services are furnished to a beneficiary at an originating 
site, which is one of the following:
    (i) The office of a physician or practitioner.
    (ii) A critical access hospital (as described in section 1861(mm)(1) 
of the Act).
    (iii) A rural health clinic (as described in section 1861(aa)(2) of 
the Act).
    (iv) A Federally qualified health center (as defined in section 
1861(aa)(4) of the Act).
    (v) A hospital (as defined in section 1861(e) of the Act).
    (4) Originating sites must be located in either a rural health 
professional shortage area as defined under section 332(a)(1)(A) of the 
Public Health Service Act (42 U.S.C. 254e(a)(1)(A)) or in a county that 
is not included in a Metropolitan Statistical Area as defined in section 
1886(d)(2)(D) of the Act. Entities participating in a Federal 
telemedicine demonstration project that have been approved by, or 
receive funding from, the Secretary as of December 31, 2000 qualify as 
an eligible originating site regardless of geographic location.
    (5) The medical examination of the patient is under the control of 
the physician or practitioner at the distant site.
    (c) Telepresenter not required. A telepresenter is not required as a 
condition of payment unless a telepresenter is medically necessary as 
determined by the physician or practitioner at the distant site.
    (d) Exception to the interactive telecommunications system 
requirement. For Federal telemedicine demonstration programs conducted 
in Alaska or Hawaii only, Medicare payment is permitted for telehealth 
when asynchronous store and forward technologies, in single or 
multimedia formats, are used as a substitute for an interactive 
telecommunications system.
    (e) Limitation. A clinical psychologist and a clinical social worker 
may bill and receive payment for individual psychotherapy via a 
telecommunications system, but may not seek payment for medical 
evaluation and management services.

[66 FR 55330, Nov. 1, 2001]

                Subpart C--Home Health Services Under SMI

Sec. 410.80  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.

   Subpart D--Comprehensive Outpatient Rehabilitation Facility (CORF) 
                                Services

Sec. 410.100  Included services.

    Subject to the conditions and limitations set forth in Secs. 410.102 
and 410.105, CORF services means the following

[[Page 278]]

services furnished to an outpatient of the CORF by personnel that meet 
the qualifications set forth in Sec. 485.70 of this chapter.
    (a) Physicians' services. The following services of the facility 
physician constitute CORF services: consultation with and medical 
supervision of non-physician staff, establishment and review of the plan 
of treatment, and other medical and facility administration activities. 
Those services are reimbursed on a reasonable cost basis under part 413 
of this chapter. Diagnostic and therapeutic services furnished to an 
individual patient are not CORF physician's services. If covered, 
payment for these services would be made by the carrier on a reasonable 
charge basis subject to the provisions of subpart E of part 405 of this 
chapter.
    (b) Physical therapy services. (1) These services include--
    (i) Testing and measurement of the function or dysfunction of the 
neuromuscular, musculoskeletal, cardiovascular and respiratory systems; 
and.
    (ii) Assessment and treatment related to dysfunction caused by 
illness or injury, and aimed at preventing or reducing disability or 
pain and restoring lost function.
    (2) The establishment of a maintenance therapy program for an 
individual whose restoration potential has been reached is a physical 
therapy service; however, maintenance therapy itself is not covered as 
part of these services.
    (c) Occupational therapy services. These services include--
    (1) Teaching of compensatory techniques to permit an individual with 
a physical impairment or limitation to engage in daily activities.
    (2) Evaluation of an individual's level of independent functioning.
    (3) Selection and teaching of task-oriented therapeutic activities 
to restore sensory-integrative function; and
    (4) Assessment of an individual's vocational potential, except when 
the assessment is related solely to vocational rehabilitation.
    (d) Speech-language pathology services. These are services for the 
diagnosis and treatment of speech and language disorders that create 
difficulties in communication.
    (e) Respiratory therapy services. (1) These are services for the 
assessment, diagnostic evaluation, treatment, management, and monitoring 
of patients with deficiencies or abnormalities of cardiopulmonary 
function.
    (2) These services include--
    (i) Application of techniques for support of oxygenation and 
ventilation of the patient and for pulmonary rehabilitation.
    (ii) Therapeutic use and monitoring of gases, mists, and aerosols 
and related equipment;
    (iii) Bronchial hygiene therapy;
    (iv) Pulmonary rehabilitation techniques such as exercise 
conditioning, breathing retraining and patient education in the 
management of respiratory problems.
    (v) Diagnostic tests to be evaluated by a physician, such as 
pulmonary function tests, spirometry and blood gas analysis; and
    (vi) Periodic assessment of chronically ill patients and their need 
for respiratory therapy.
    (f) Prosthetic device services. These services include--
    (1) Prosthetic devices (excluding dental devices and renal dialysis 
machines), that replace all or part of an internal body organ or 
external body member (including contiguous tissue) or replace all or 
part of the function of a permanently inoperative or malfunctioning 
external body member or internal body organ; and
    (2) Services necessary to design the device, select materials and 
components, measure, fit, and align the device, and instruct the patient 
in its use.
    (g) Orthotic device services. These services include--
    (1) Orthopedic devices that support or align movable parts of the 
body, prevent or correct deformities, or improve functioning; and
    (2) Services necessary to design the device, select the materials 
and components, measure, fit, and align the device, and instruct the 
patient in its use.
    (h) Social services. These services include--
    (1) Assessment of the social and emotional factors related to the 
individual's illness, need for care, response to

[[Page 279]]

treatment, and adjustment to care furnished by the facility;
    (2) Casework services to assist in resolving social or emotional 
problems that may have an adverse effect on the beneficiary's ability to 
respond to treatment; and
    (3) Assessment of the relationship of the individual's medical and 
nursing requirements to his or her home situation, financial resources, 
and the community resources available upon discharge from facility care.
    (i) Psychological services. These services include--
    (1) Assessment, diagnosis and treatment of an individual's mental 
and emotional functioning as it relates to the individual's 
rehabilitation;
    (2) Psychological evaluations of the individual's response to and 
rate of progress under the treatment plan; and
    (3) Assessment of those aspects of an individual's family and home 
situation that affect the individual's rehabilitation treatment.
    (j) Nursing care services. These services include nursing services 
specified in the plan of treatment and any other nursing services 
necessary for the attainment of the rehabilitation goals.
    (k) Drugs and biologicals. These are drugs and biologicals that are-
-
    (1) Prescribed by a physician and administered by or under the 
supervision of a physician or a registered professional nurse; and
    (2) Not excluded from Medicare Part B payment for reasons specified 
in Sec. 410.29.
    (l) Supplies, appliances, and equipment. These include--
    (1) Non-reusable supplies such as oxygen and bandages;
    (2) Medical equipment and appliances; and
    (3) Durable medical equipment of the type specified in Sec. 410.38, 
(except renal dialysis systems) for use outside the CORF, whether 
purchased or rented.
    (m) Home environment evaluation. This is a single home visit to 
evaluate the potential impact of the home situation on the 
rehabilitation goals.

[51 FR 41339, Nov. 14, 1986; 52 FR 4499, Feb. 12, 1987]

Sec. 410.102  Excluded services.

    None of the services specified in Sec. 410.100 is covered as a CORF 
service if the service--
    (a) Would not be covered as an inpatient hospital service if 
furnished to a hospital inpatient;
    (b) Is not reasonable and necessary for the diagnosis or treatment 
of illness or injury or to improve the functioning of a malformed body 
member. An example would be services furnished as part of a maintenance 
program involving repetitive activities that do not require the skilled 
services of nurses or therapists.

Sec. 410.105  Requirements for coverage of CORF services.

    Services specified in Sec. 410.100 and not excluded under 
Sec. 410.102 are covered as CORF services if they are furnished by a 
participating CORF (that is, a CORF that meets the conditions of subpart 
B of part 485 of this chapter, and has in effect a provider agreement 
under part 489 of this chapter) and if the following requirements are 
met:
    (a) Referral and medical history. The services must be furnished to 
an individual who is referred by a physician who certifies that the 
individual needs skilled rehabilitation services, and makes the 
following information available to the CORF before or at the time 
treatment is begun:
    (1) The individual's significant medical history.
    (2) Current medical findings.
    (3) Diagnosis(es) and contraindications to any treatment modality.
    (4) Rehabilitation goals, if determined.
    (b) When and where services are furnished. (1) All services must be 
furnished while the individual is under the care of a physician.
    (2) Except as provided in paragraph (b)(3) of this section, the 
services must be furnished on the premises of the CORF.
    (3) Exceptions. (i) Physical therapy, occupational therapy, and 
speech pathology services may be furnished away from the premises of the 
CORF.
    (ii) The single home visit specified in Sec. 410.100(m) is also 
covered.

[[Page 280]]

    (c) Plan of treatment. (1) The services must be furnished under a 
written plan of treatment that--
    (i) Is established and signed by a physician before treatment is 
begun; and
    (ii) Prescribes the type, amount, frequency, and duration of the 
services to be furnished, and indicates the diagnosis and anticipated 
rehabilitation goals.
    (2) The plan must be reviewed at least every 60 days by a facility 
physician who, when appropriate, consults with the professional 
personnel providing the services.
    (3) The reviewing physician must certify or recertify that the plan 
is being followed, the patient is making progress in attaining the 
rehabilitation goals, and the treatment is having no harmful effects on 
the patient.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 8841, Mar. 1, 1991]

  Subpart E--Community Mental Health Centers (CMHCs) Providing Partial 
                        Hospitalization Services

Sec. 410.110  Requirements for coverage of partial hospitalization 
          services by CMHCs.

    Medicare part B covers partial hospitalization services furnished by 
or under arrangements made by a CMHC if they are provided by a CMHC as 
defined in Sec. 410.2 that has in effect a provider agreement under part 
489 of this chapter and if the services are--
    (a) Prescribed by a physician and furnished under the general 
supervision of a physician;
    (b) Subject to certification by a physician in accordance with 
Sec. 424.24(e)(1) of this subchapter; and
    (c) Furnished under a plan of treatment that meets the requirements 
of Sec. 424.24(e)(2) of this subchapter.

[59 FR 6577, Feb. 11, 1994]

Subpart F [Reserved]

                  Subpart G--Medical Nutrition Therapy

    Source: 66 FR 55331, Nov. 1, 2001, unless otherwise noted.

Sec. 410.130  Definitions.

    For the purposes of this subpart, the following definitions apply:
    Chronic renal insufficiency means the stage of renal disease 
associated with a reduction in renal function not severe enough to 
require dialysis or transplantation (glomerular filtration rate [GFR] 
13-50 ml/min/1.73m\2\).
    Diabetes means diabetes mellitus consisting of two types. Type 1 is 
an autoimmune disease that destroys the beta cells of the pancreas, 
leading to insulin deficiency. Type 2 is familial hyperglycemia that 
occurs primarily in adults but can also occur in children and 
adolescents. It is caused by an insulin resistance whose etiology is 
multiple and not totally understood. Gestational diabetes is any degree 
of glucose intolerance with onset or first recognition during pregnancy. 
The diagnostic criterion for a diagnosis of diabetes for a fasting 
glucose tolerance test is greater than or equal to 126 mg/dL.
    Episode of care means services covered in a 12-month time period 
when coordinated with initial diabetes self-management training (DSMT) 
and one calendar year for each year thereafter, starting with the 
assessment and including all covered interventions based on referral(s) 
from a physician as specified in Sec. 410.132(c). The time period 
covered for gestational diabetes extends only until the pregnancy ends.
    Medical nutrition therapy services means nutritional diagnostic, 
therapeutic, and counseling services provided by a registered dietitian 
or nutrition professional for the purpose of managing diabetes or a 
renal disease.
    Physician means a doctor of medicine or osteopathy legally 
authorized to practice medicine and surgery by the State in which he or 
she performs such function or action (including a physician within the 
meaning of section of 1101(a)(7) of the Act).
    Renal disease means chronic renal insufficiency, end-stage renal 
disease when dialysis is not received, or the medical condition of a 
beneficiary for 36 months after kidney transplant.
    Treating physician means the primary care physician or specialist 
coordinating care for the beneficiary with diabetes or renal disease.

[[Page 281]]

Sec. 410.132  Medical nutrition therapy.

    (a) Conditions for coverage of MNT services. Medicare Part B pays 
for MNT services provided by a registered dietitian or nutrition 
professional as defined in Sec. 410.134 when the beneficiary is referred 
for the service by the treating physician. Services covered consist of 
face-to-face nutritional assessments and interventions in accordance 
with nationally accepted dietary or nutritional protocols.
    (b) Limitations on coverage of MNT services.
    (1) MNT services based on a diagnosis of renal disease as described 
in this subpart are not covered for beneficiaries receiving maintenance 
dialysis for which payment is made under section 1881 of the Act.
    (2) A beneficiary may only receive the maximum number of hours 
covered under the DSMT benefit for both DSMT and MNT during the initial 
DSMT training period unless additional hours are determined to be 
medically necessary under the national coverage determination process.
    (3) In years when the beneficiary is eligible for MNT and follow-up 
DSMT, the beneficiary may only receive the maximum number of hours 
covered under MNT unless additional hours are determined to be medically 
necessary under the national coverage determination process.
    (4) If a beneficiary has both diabetes and renal disease, the 
beneficiary may only receive the maximum number of hours covered under 
the renal MNT benefit in one episode of care unless he or she is 
receiving initial DSMT services, in which case the beneficiary would 
receive whichever is greater.
    (5) An exception to the maximum number of hours in (b)(2), (3), and 
(4) of this section may be made when the treating physician determines 
that there is a change of diagnosis, medical condition, or treatment 
regimen related to diabetes or renal disease that requires a change in 
MNT during an episode of care.
    (c) Referrals. Referral may only be made by the treating physician 
when the beneficiary has been diagnosed with diabetes or renal disease 
as defined in this subpart with documentation maintained by the 
referring physician in the beneficiary's medical record. Referrals must 
be made for each episode of care and any additional assessments or 
interventions required by a change of diagnosis, medical condition, or 
treatment regimen during an episode of care.

Sec. 410.134  Provider qualifications.

    For Medicare Part B coverage of MNT, only a registered dietitian or 
nutrition professional may provide the services. ``Registered dietitian 
or nutrition professional'' means an individual who, on or after 
December 22, 2000:
    (a) Holds a bachelor's or higher degree granted by a regionally 
accredited college or university in the United States (or an equivalent 
foreign degree) with completion of the academic requirements of a 
program in nutrition or dietetics accredited by an appropriate national 
accreditation organization recognized for this purpose.
    (b) Has completed at least 900 hours of supervised dietetics 
practice under the supervision of a registered dietitian or nutrition 
professional.
    (c) Is licensed or certified as a dietitian or nutrition 
professional by the State in which the services are performed. In a 
State that does not provide for licensure or certification, the 
individual will be deemed to have met this requirement if he or she is 
recognized as a ``registered dietitian'' by the Commission on Dietetic 
Registration or its successor organization, or meets the requirements of 
paragraphs (a) and (b) of this section.
    (d) Exceptions.
    (i) A dietitian or nutritionist licensed or certified in a State as 
of December 21, 2000 is not required to meet the requirements of (a) and 
(b) of this section.
    (ii) A ``registered dietitian'' in good standing, as recognized by 
the Commission of Dietetic Registration or its successor organization, 
is deemed to have met the requirements of (a) and (b) of this section.

[66 55331, Nov. 1, 2001; 67 FR 20684, Apr. 26, 2002]

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  Subpart H--Outpatient Diabetes Self-Management Training and Diabetes 
                          Outcome Measurements

    Source: 65 FR 83148, Dec. 29, 2000, unless otherwise noted.

Sec. 410.140  Definitions.

    For purposes of this subpart, the following definitions apply:
    ADA stands for the American Diabetes Association.
    Approved entity means an individual, physician, or entity accredited 
by an approved organization as meeting one of the sets of quality 
standards described in Sec. 410.144 and approved by CMS under 
Sec. 410.141(e) to furnish training.
    Deemed entity means an individual, physician, or entity accredited 
by an approved organization, but that has not yet been approved by CMS 
to furnish and receive Medicare payment for the training. Upon being 
approved by CMS under Sec. 410.141(e) to furnish training, CMS refers to 
this entity as an ``approved entity''.
    NSDSMEP stands for the National Standards for Diabetes Self 
Management Education Programs.
    Organization means a national accreditation organization.
    Rural means an area that meets one of the following conditions:
    (1) Is not urbanized (as defined by the Bureau of the Census) and 
that is designated by the chief executive officer of the State, and 
certified by the Secretary, as an area with a shortage of personal 
health services.
    (2) Is designated by the Secretary either as an area with a shortage 
of personal health services or as a health professional shortage area.
    (3) Is designated by the Indian Health Service as a health service 
delivery area as defined in Sec. 36.15 of this title.
    Training means outpatient diabetes self-management training.

Sec. 410.141  Outpatient diabetes self-management training.

    (a) General rule. Medicare Part B covers training defined in 
Sec. 410.140 if all of the conditions and requirements of this subpart 
are met.
    (b) Conditions for coverage. The training must meet the following 
conditions:
    (1) Training orders. Following an evaluation of the beneficiary's 
need for the training, it is ordered by the physician (or qualified 
nonphysician practitioner) (as defined in Sec. 410.32(a)) treating the 
beneficiary's diabetes.
    (2) Plan of care. It is included in a comprehensive plan of care 
established by the physician (or qualified nonphysician practitioner) 
treating the beneficiary for diabetes that meets the following 
requirements:
    (i) Describes the content, number of sessions, frequency, and 
duration of the training as written by the physician (or qualified 
nonphysician practitioner) treating the beneficiary.
    (ii) Contains a statement specified by CMS and signed by the 
physician (or qualified nonphysician practitioner) managing the 
beneficiary's diabetic condition. By signing this statement, the 
physician (or qualified nonphysician practitioner) certifies that he or 
she is managing the beneficiary's diabetic condition and the training 
described in the plan of care is needed to ensure therapy compliance or 
to provide the beneficiary with the skills and knowledge to help manage 
the beneficiary's diabetes. The physician's (or qualified nonphysician 
practitioner's) statement must identify the beneficiary's specific 
medical conditions (described in paragraph (d) of this section) that the 
training will address.
    (iii) Provides that any changes to the plan of care are signed by 
the physician (or qualified nonphysician practitioner) treating the 
beneficiary.
    (iv) Is incorporated into the approved entity's medical record for 
the beneficiary and is made available, upon request, to CMS.
    (3) Reasonable and necessary. It is reasonable and necessary for 
treating or monitoring the condition of a beneficiary who meets the 
conditions described in paragraph (d) of this section.
    (c) Types and frequency of training--(1) Initial training--
    General rule. (i) Medicare Part B covers initial training that meets 
the following conditions:

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    (A) Is furnished to a beneficiary who has not previously received 
initial training under this benefit.
    (B) Is furnished within a continuous 12-month period.
    (C) Does not exceed a total of 10 hours.
    (D) Except as permitted under paragraph (c)(1)(ii) of this section, 
9 hours of the training are furnished in a group setting consisting of 2 
to 20 individuals who need not all be Medicare beneficiaries.
    (E) Is furnished in increments of no less than one-half hour.
    (F) May include 1 hour of individual training for an assessment of 
the beneficiary's training needs.
    (ii)
    Exception. Medicare covers training on an individual basis for a 
Medicare beneficiary who meets any of the following conditions:
    (A) No group session is available within 2 months of the date the 
training is ordered.
    (B) The beneficiary's physician (or qualified nonphysician 
practitioner) documents in the beneficiary's medical record that the 
beneficiary has special needs resulting from conditions, such as severe 
vision, hearing, or language limitations that will hinder effective 
participation in a group training session.
    (2)
    Follow-up training. After receiving the initial training described 
in paragraph (c)(1) of this section, Medicare covers follow-up training 
that meets the following conditions:
    (i) Consists of no more than 2 hours individual or group training 
for a beneficiary each year.
    (ii) Group training consists of 2 to 20 individuals who need not all 
be Medicare beneficiaries.
    (iii) Is furnished any time in a calendar year following the year in 
which the beneficiary completes the initial training.
    (iv) Is furnished in increments of no less than one-half hour.
    (v) The physician (or qualified nonphysician practitioner) treating 
the beneficiary must document, in the referral for training and the 
beneficiary's medical record, the specific medical condition (described 
in paragraph (d) of this section) that the follow-up training must 
address.
    (d) Beneficiaries who may be covered. Medicare Part B covers one 
course of initial training for a beneficiary who has one or more of the 
following medical conditions present within the 12-month period before 
the physician's order for the training:
    (1) New onset diabetes.
    (2) Inadequate glycemic control as evidenced by a glycosylated 
hemoglobin (HbA1C) level of 8.5 percent or more on two consecutive HbA1C 
determinations 3 or more months apart in the year before the beneficiary 
begins receiving training.
    (3) A change in treatment regimen from no diabetes medications to 
any diabetes medication, or from oral diabetes medication to insulin.
    (4) High risk for complications based on inadequate glycemic control 
(documented acute episodes of severe hypoglycemia or acute severe 
hyperglycemia occurring in the past year during which the beneficiary 
needed emergency room visits or hospitalization).
    (5) High risk based on at least one of the following documented 
complications:
    (i) Lack of feeling in the foot or other foot complications such as 
foot ulcers, deformities, or amputation.
    (ii) Pre-proliferative or proliferative retinopathy or prior laser 
treatment of the eye.
    (iii) Kidney complications related to diabetes, when manifested by 
albuminuria, without other cause, or elevated creatinine.
    (e) Who may furnish services. Training may be furnished by a 
physician, individual, or entity that meets the following conditions:
    (1) Furnishes other services for which direct Medicare payment may 
be made.
    (2) May properly receive Medicare payment under Sec. 424.73 or 
Sec. 424.80 of this chapter, which set forth prohibitions on assignment 
and reassignment of <STRONG>benefits</STRONG>.
    (3) Submits necessary documentation to, and is accredited by, an 
accreditation organization approved by CMS under Sec. 410.142 to meet 
one of the sets of quality standards described in Sec. 410.144.

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    (4) Provides documentation to CMS, as requested, including diabetes 
outcome measurements set forth at Sec. 410.146.

Sec. 410.142  CMS process for approving national accreditation 
          organizations.

    (a) General rule. CMS may approve and recognize a nonprofit or not-
for-profit organization with demonstrated experience in representing the 
interest of individuals with diabetes to accredit entities to furnish 
training.
    (b) Required information and materials. An organization requesting 
CMS's approval and recognition of its accreditation program must furnish 
to CMS the following information and materials:
    (1) The requirements and quality standards that the organization 
uses to accredit entities to furnish training.
    (2) If an organization does not use the CMS quality standards or the 
NSDSMEP quality standards described in Sec. 410.144(a) or (b), a 
detailed comparison including a crosswalk between the organization's 
standards and the CMS quality standards described in Sec. 410.144(a).
    (3) Detailed information about the organization's accreditation 
process, including all of the following information:
    (i) Frequency of accreditation.
    (ii) Copies of accreditation forms, guidelines, and instructions to 
evaluators.
    (iii) Descriptions of the following:
    (A) The accreditation review process and the accreditation status 
decision making process.
    (B) The procedures used to notify a deemed entity of deficiencies in 
its outpatient diabetes self-management training program and procedures 
to monitor the correction of those deficiencies.
    (C) The procedures used to enforce compliance with the accreditation 
requirements and standards.
    (4) Detailed information about the individuals who perform 
evaluations for the organization, including all of the following 
information:
    (i) The education and experience requirements for the individuals 
who perform evaluations.
    (ii) The content and frequency of continuing education furnished to 
the individuals who perform evaluations.
    (iii) The process used to monitor the performance of individuals who 
perform evaluations.
    (iv) The organization's policies and practices for participation in 
the accreditation process by an individual who is professionally or 
financially affiliated with the entity being evaluated.
    (5) A description of the organization's data management and analysis 
system for its accreditation activities and decisions, including the 
kinds of reports, tables, and other displays generated by that system.
    (6) A description of the organization's procedures for responding to 
and investigating complaints against an approved entity, including 
policies and procedures regarding coordination of these activities with 
appropriate licensing bodies, ombudsmen programs, and CMS.
    (7) A description of the organization's policies and procedures for 
withholding or removing a certificate of accreditation for failure to 
meet the organization's standards or requirements, and other actions the 
organization takes in response to noncompliance with its standards and 
requirements.
    (8) A description of all types (for example, full or partial) and 
categories (for example, provisional, conditional, or temporary) of 
accreditation offered by the organization, the duration of each type and 
category of accreditation, and a statement identifying the types and 
categories that will serve as a basis for accreditation if CMS approves 
the organization.
    (9) A list of all of the approved entities currently accredited to 
furnish training and the type, category, and expiration date of the 
accreditation held by each of them.
    (10) The name and address of each person with an ownership or 
control interest in the organization.
    (11) Documentation that demonstrates its ability to furnish CMS with 
electronic data in CMS-compatible format.
    (12) A resource analysis that demonstrates that its staffing, 
funding, and

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other resources are adequate to perform the required accreditation 
activities.
    (13) A statement acknowledging that, as a condition for approval and 
recognition by CMS of its accreditation program, it agrees to comply 
with the requirements set forth in Secs. 410.142 through 410.146.
    (14) Additional information CMS requests to enable it to respond to 
the organization's request for CMS approval and recognition of its 
accreditation program to accredit entities to furnish training.
    (c) Onsite visit. CMS may visit the prospective organization's 
offices to verify information in the organization's application, 
including, but not limited to, review of documents, and interviews with 
the organization's staff.
    (d) Notice and comment--(1) Proposed notice. CMS publishes a 
proposed notice in the Federal Register announcing its intention to 
approve an organization's request for CMS approval and recognition of 
its accreditation program and the standards it uses to accredit entities 
to furnish training. The notice includes the following information:
    (i) The basis for approving the organization.
    (ii) A description of how the organization's accreditation program 
applies and enforces quality standards that have been determined by CMS 
to meet or exceed the CMS quality standards described in Sec. 410.144(a) 
or how the organization would use the NSDSMEP quality standards 
described in Sec. 410.144(b).
    (iii) An opportunity for public comment.
    (2) Final notice. (i) After considering public comments CMS receives 
on the proposed notice, it publishes a final notice in the Federal 
Register indicating whether it has approved an organization's request 
for CMS approval and recognition of its accreditation program and the 
standards it uses to accredit entities to furnish training.
    (ii) If CMS approves the request, the final notice specifies the 
effective date and the term of the approval, which may not exceed 6 
years.
    (e) Criteria CMS uses to approve national accreditation 
organizations. In deciding to approve and recognize an organization's 
accreditation program to accredit entities to furnish training, CMS 
considers the following criteria:
    (1) The organization uses and enforces quality standards that CMS 
has determined meet or exceed the CMS quality standards described in 
Sec. 410.144(a), or uses the NSDSMEP quality standards described in 
Sec. 410.144(b).
    (2) The organization meets the requirements for approved 
organizations in Sec. 410.143.
    (3) The organization is not owned or controlled by the entities it 
accredits, as defined in Sec. 413.17(b)(2) or (b)(3), respectively, of 
this chapter.
    (4) The organization does not accredit any entity it owns or 
controls.
    (f) Notice of CMS's decision. CMS notifies the prospective 
organization in writing of its decision. The notice includes the 
following information:
    (1) Statement of approval or denial.
    (2) If approved, the expiration date of CMS's approval and 
recognition of the accreditation program.
    (3) If denied, the rationale for the denial and the reconsideration 
and reapplication procedures.
    (g) Reconsideration of adverse decision. An organization that has 
received CMS's notice of denial of its request for CMS approval and 
recognition of its accreditation program to accredit entities to furnish 
training may request reconsideration of CMS's decision in accordance 
with part 488 subpart D of this chapter.
    (h) Request for approval following denial. (1) Except as provided in 
paragraph (h)(2) of this section, an organization that has received 
CMS's notice of denial of its request for CMS approval and recognition 
of its accreditation program to accredit entities to furnish training 
may submit a new request to CMS if it meets the following conditions:
    (i) Has revised its accreditation program to correct the 
deficiencies CMS noted in its denial notice.
    (ii) Demonstrates, through documentation, the use of one of the sets 
of quality standards described in Sec. 410.144.
    (iii) Resubmits the application in its entirety.

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    (2) For an organization that has requested reconsideration of CMS's 
denial of its request for CMS approval and recognition of its 
accreditation program to accredit entities to furnish training, CMS will 
not consider the organization's new request until all administrative 
proceedings on the previous request have been completed.
    (i) Withdrawal. An organization requesting CMS approval and 
recognition of its accreditation program to accredit entities may 
withdraw its application at any time.
    (j) Applying for continued CMS approval. At least 6 months before 
the expiration of CMS's approval and recognition of the organization's 
program, an organization must request from CMS continued approval and 
recognition.

Sec. 410.143  Requirements for approved accreditation organizations.

    (a) Ongoing responsibilities of an approved accreditation 
organization. An organization approved and recognized by CMS must 
undertake the following activities on an ongoing basis:
    (1) Provide to CMS in writing, on a monthly basis, all of the 
following:
    (i) Copies of all accreditation decisions and any accreditation-
related information that CMS may require (including corrective action 
plans and summaries of unmet quality standards described in 
Sec. 410.144).
    (ii) Notice of all complaints related to approved entities.
    (iii) Within 30 days of taking remedial or adverse action (including 
revocation, withdrawal, or revision of an approved entity's deemed 
status) against an approved entity, information describing the remedial 
or adverse action and the circumstances that led to taking the action.
    (iv) Notice of any proposed changes in its accreditation standards 
and requirements or evaluation process. If an organization implements 
changes without CMS approval (other than changes to the NSDSMEP quality 
standards described in Sec. 410.144(b)), CMS may withdraw its approval 
and recognition of the organization's accreditation program.
    (2) If an organization does not use the NSDSMEP quality standards 
described in Sec. 410.144(b), and wishes to change its quality standards 
that CMS previously approved, the organization must submit its plan to 
alter its quality standards and include a crosswalk between the set of 
quality standards described in Sec. 410.144 and the organization's 
revised standards. If an organization implements changes in its quality 
standards without CMS approval, CMS may withdraw its approval and 
recognition of the organization's accreditation program.
    (3) If CMS notifies an organization that uses the CMS quality 
standards described in Sec. 410.144(a) that it has changed the CMS 
quality standards, the organization must meet the following 
requirements:
    (i) Submit to CMS, within 30 days of CMS's notification of a change 
in the quality standards, its organization's plan to alter its quality 
standards to conform to the revised quality standards described in 
Sec. 410.144(a).
    (ii) Implement the changes to its accreditation program by the 
implementation date specified in CMS's notification of the changes in 
the quality standards.
    (b) CMS oversight of approved national accreditation organizations. 
CMS, or its agent, performs oversight activities to ensure that an 
approved organization and the entities the organization accredits 
continue to meet a set of quality standards described in Sec. 410.144. 
CMS (or its agent) uses the following procedures:
    (1) Equivalency review. CMS compares the organization's standards 
and its application and enforcement of its standards to a set of quality 
standards (described in Sec. 410.144) and processes when any of the 
following conditions exist:
    (i) CMS imposes new requirements or changes its process for 
approving and recognizing an organization.
    (ii) Except for an organization that uses the NSDSMEP quality 
standards, the organization proposes to adopt new standards or changes 
its accreditation process.
    (iii) The organization reapplies to CMS for continuation of its 
approval and recognition by CMS of its program to accredit entities to 
furnish training.

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    (2) Validation reviews. CMS validates an organization's 
accreditation process by conducting evaluations of approved entities 
accredited by the organization and comparing its results to the results 
of the organization's evaluation of the approved entities.
    (3) Onsite inspections. CMS may conduct an onsite inspection of the 
organization's operations and offices to verify information and assess 
the organization's compliance with its own policies and procedures. The 
onsite inspection may include, but is not limited to, reviewing 
documents, auditing documentation of meetings concerning the 
accreditation process, evaluating accreditation results or the 
accreditation status decision making process, and interviewing the 
organization's staff.
    (4) Withdrawal of CMS approval and recognition--(i) CMS gives an 
organization written notice of CMS's intent to withdraw its approval and 
recognition of the organization's program to accredit entities if CMS 
determines through an equivalency review, validation review, onsite 
inspection, or CMS's daily experience with the organization that any of 
the following conditions exist:
    (A) Except for those accrediting organizations using quality 
standards in Sec. 410.144(b), the quality standards that the 
organization applies and enforces do not meet or exceed the CMS quality 
standards described in Sec. 410.144(a).
    (B) The organization has failed to meet the requirements for 
accreditation in Secs. 410.142 through 410.144.
    (ii) Request for reconsideration. An organization may request a 
reconsideration of CMS's decision to withdraw its approval and 
recognition of the organization in accordance with part 488, subpart D 
of this chapter.

Sec. 410.144  Quality standards for deemed entities.

    An organization approved and recognized by CMS may accredit an 
entity to meet one of the following sets of quality standards:
    (a) CMS quality standards. Standards prescribed by CMS, which 
include the following:
    (1) Organizational structure. (i) Provides the educational resources 
to support the programs offered and the beneficiaries served, including 
adequate space, personnel, budget, instructional materials, 
confidentiality, privacy, and operational support.
    (ii) Defines clearly and documents the organizational relationships, 
lines of authority, staffing, job descriptions, and operational 
policies.
    (iii) Maintains a written policy that affirms education as an 
integral component of diabetes care.
    (iv) Includes in its operational policies, specific standards and 
procedures identifying the amount of collaborative, interactive, skill-
based training methods and didactic training methods furnished to the 
beneficiary.
    (v) Assesses the service area to define the target population in 
order to appropriately allocate personnel and resources.
    (vi) Identifies in its operational policies, the minimal amount that 
each team member must be involved in the following:
    (A) Development of training materials.
    (B) Instruction of beneficiaries.
    (2) Environment. Maintains a safe and sanitary environment, properly 
constructed, equipped, and maintained to protect the health and safety 
of all patients and that meets all applicable fire protection and life 
safety codes.
    (3) Program staff. (i) Requires a program coordinator who is 
responsible for program planning, implementation, and evaluation.
    (ii) Requires nonphysician professional staff to obtain 12 hours of 
continuing diabetes education concerning educational principles and 
behavior change strategies every 2 years.
    (4) Team approach. (i) Except as provided in paragraph (a)(4)(ii) of 
this section for a rural area, furnishes services using a 
multidisciplinary instructional team that meets the following 
requirements:
    (A) The team includes at least a registered dietitian, as recognized 
under State law, and a certified diabetes educator (CDE), certified by a 
qualified organization that has registered with CMS, who have didactic 
experience and knowledge of diabetes clinical and educational issues. 
(If the team includes a registered nurse, an approved entity

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may delay implementation of the requirement for a CDE until February 27, 
2004.)
    (B) The team is qualified to teach the training content areas 
required in paragraph (a)(5) of this section.
    (C) All appropriate team members must be present during the portion 
of the training for which they are responsible and must directly furnish 
the training within the <STRONG>scope</STRONG> of their practices.
    (ii) In a rural area, an individual who is qualified as a registered 
dietitian and as a CDE that is currently certified by an organization 
approved by CMS (or until February 27, 2004 an individual who is 
qualified as a registered dietitian and as a registered nurse) may 
furnish training and is deemed to meet the multidisciplinary team 
requirement in paragraph (a)(4)(i) of this section.
    (5) Training content. Offers training and is capable of meeting the 
needs of its patients on the following subjects:
    (i) Diabetes overview/pathophysiology of diabetes.
    (ii) Nutrition.
    (iii) Exercise and activity.
    (iv) Diabetes medications (including skills related to the self-
administration of injectable drugs).
    (v) Self-monitoring and use of the results.
    (vi) Prevention, detection, and treatment of acute complications.
    (vii) Prevention, detection, and treatment of chronic complications.
    (viii) Foot, skin, and dental care.
    (ix) Behavior change strategies, goal setting, risk factor 
reduction, and problem solving.
    (x) Preconception care, pregnancy, and gestational diabetes.
    (xi) Relationships among nutrition, exercise, medication, and blood 
glucose levels.
    (xii) Stress and psychosocial adjustment.
    (xiii) Family involvement and social support.
    (xiv) <STRONG>Benefits</STRONG>, risks, and management options for improving glucose 
control.
    (xv) Use of health care systems and community resources.
    (6) Training methods. (i) Offers individual and group instruction 
for effective training.
    (ii) Uses instructional methods and materials that are appropriate 
for the target population, and participants being served.
    (iii) Uses primarily interactive, collaborative, skill-based 
training methods and maximizes the use of interactive training methods.
    (7) Review of plan of care and goals. (i) Reviews each beneficiary's 
plan of care.
    (ii) Develops and updates an individual assessment, in collaboration 
with each beneficiary, that includes relevant medical history, present 
health status, health service or resource utilization, risk factors, 
diabetes knowledge and skills, cultural influences, health beliefs and 
attitudes, health behaviors and goals, support systems, barriers to 
learning, and socioeconomic factors.
    (iii) Based on the assessment, develops, in collaboration with each 
beneficiary, an individual education plan. Includes in the education 
plan, the goals for education, the periodic updates, the specific amount 
of interactive, collaborative, skill-based training methods and didactic 
training methods that have been and will be furnished.
    (iv) Documents the results, including assessment, intervention, 
evaluation and follow-up in the beneficiary's medical record.
    (v) Forwards a copy of the documentation in paragraph (a)(7)(ii) 
through (iv) of this section to the referring physician (or qualified 
nonphysician practitioner).
    (vi) Periodically updates the beneficiary's referring physician (or 
qualified nonphysician practitioner) about the beneficiary's educational 
status.
    (8) Educational intervention. Offers appropriate and timely 
educational intervention based on referral from the beneficiary's 
physician (or qualified nonphysician practitioner) and based on periodic 
reassessments of health status, knowledge, skills, attitudes, goals, and 
self-care behaviors.
    (9) Performance measurement and quality improvement. Establishes and

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maintains an effective internal performance measurement and quality 
improvement program that focuses on maximizing outcomes by improving 
patient safety and quality of care. The program must meet the following 
requirements:
    (i) Stresses health outcomes (for example, improved beneficiary 
diabetes control, beneficiary understanding, or beneficiary compliance) 
and provides for the collection, analysis, and reporting of data that 
permits measurement of performance outcomes, or other quality 
indicators.
    (ii) Requires an entity to take the following actions:
    (A) Evaluate itself on an annual basis as to its effectiveness in 
using performance measures.
    (B) Improve its performance on at least one outcome or quality 
indicator each year.
    (10) Quality improvement. Has an agreement with a QIO to participate 
in quality improvement projects defined by the QIO, or if a program 
elects not to participate in a QIO project, it must be able to 
demonstrate a level of achievement through a project of its own design 
that is comparable to or better than the achievement to be expected from 
participation in the QIO quality improvement project.
    (b) The National Standards for Diabetes Self-Management Education 
Programs. The set of quality standards contained in the NSDSMEP or any 
NSDSMEP standards subsequently revised.
    (c) Standards of a national accreditation organization that 
represents individuals with diabetes. Standards that meet or exceed the 
CMS quality standards described in paragraph (a) of this section that 
have been developed by a national organization (and approved by CMS) 
that is either a nonprofit or not-for-profit organization with 
demonstrated experience in representing the interest of individuals, 
including health care professionals and Medicare beneficiaries, with 
diabetes.

Sec. 410.145  Requirements for entities.

    (a) Deemed entities. (1) Except as permitted in paragraph (a)(2) of 
this section, an entity may be deemed to meet a set of quality standards 
described in Sec. 410.144 if the following conditions are met:
    (i) The entity has submitted necessary documentation and is fully 
accredited (and periodically reaccredited) by an organization approved 
by CMS under Sec. 410.142.
    (ii) The entity is not accredited by an organization that owns or 
controls the entity.
    (2) Before August 27, 2002 CMS may deem an entity to meet the 
NSDSMEP quality standards described in Sec. 410.144(b), if the entity 
provides the Medicare contractor that will process its claims with a 
copy of a current certificate the entity received from the ADA that 
verifies the training program it furnishes meets the NSDSMEP quality 
standards described in Sec. 410.144(b).
    (b) Approved entities. An entity may be approved to furnish training 
if the entity meets the following conditions:
    (1) Before submitting a claim for Medicare payment, forwards a copy 
of its certificate or proof of accreditation from an organization 
approved by CMS under Sec. 410.142 indicating that the entity meets a 
set of quality standards described in Sec. 410.144, or before August 27, 
2002, submits documentation of its current ADA recognition status.
    (2) Agrees to submit to evaluation (including onsite inspections) by 
CMS (or its agent) to validate its approved organization's accreditation 
process.
    (3) Authorizes its approved organization to release to CMS a copy of 
its most recent accreditation evaluation, and any accreditation-related 
information that CMS may require.
    (4) At a minimum, allows the QIO (under a contract with CMS) access 
to beneficiary or group training records.
    (c) Effective dates--(1) Deemed to meet quality standards. Except as 
permitted in paragraph (c)(2) of this section, the date on which an 
entity is deemed to meet a set of quality standards described in 
Sec. 410.144 is the later of one of the following dates:
    (i) The date CMS approves and recognizes the accreditation 
organization to accredit entities to furnish training.
    (ii) The date an organization accredits the entity to meet a set of 
quality standards described in Sec. 410.144.

[[Page 290]]

    (2) Approved to furnish training. CMS covers the training furnished 
by an entity beginning on the later of one of the following dates:
    (i) The date CMS approves the deemed entity as meeting the 
conditions for coverage in Sec. 410.141(e).
    (ii) The date the entity is deemed to meet a set of quality 
standards described in Sec. 410.144.
    (d) Removal of approved status--(1) General rule. CMS removes an 
entity's approved status for any of the following reasons:
    (i) CMS determines, on the basis of its own evaluation or the 
results of the accreditation evaluation, that the entity does not meet a 
set of quality standards described in Sec. 410.144.
    (ii) CMS withdraws its approval of the organization that deemed the 
entity to meet a set of quality standards described in Sec. 410.144.
    (iii) The entity fails to meet the requirements of paragraphs (a) 
and (b) of this section.
    (2) Effective date. The effective date of CMS's removal of an 
entity's approved status is 60 days after the date of CMS's notice to 
the entity.

Sec. 410.146  Diabetes outcome measurements.

    (a) Information collection. An approved entity must collect and 
record in an organized systematic manner the following patient 
assessment information at least on a quarterly basis for a beneficiary 
who receives training under Sec. 410.141:
    (1) Medical information that includes the following:
    (i) Duration of the diabetic condition.
    (ii) Use of insulin or oral agents.
    (iii) Height and weight by date.
    (iv) Results and date of last lipid test.
    (v) Results and date of last HbA1C.
    (vi) Information on self-monitoring (frequency and results).
    (vii) Blood pressure with the corresponding dates.
    (viii) Date of the last eye exam.
    (2) Other information that includes the following:
    (i) Educational goals.
    (ii) Assessment of educational needs.
    (iii) Training goals.
    (iv) Plan for a follow-up assessment of achievement of training 
goals between 6 months and 1 year after the beneficiary completes the 
training.
    (v) Documentation of the training goals assessment.
    (b) Follow-up assessment information. An approved entity may obtain 
information from the beneficiary's survey, primary care physician 
contact, and follow-up visits.

                   Subpart I--Payment of SMI <STRONG>Benefits</STRONG>

    Source: 51 FR 41339, Nov. 14, 1986. Redesignated at 59 FR 6577, Feb. 
11, 1994.

Sec. 410.150  To whom payment is made.

    (a) General rules. (1) Any SMI enrollee is, subject to the 
conditions, limitations, and exclusions set forth in this part and in 
parts 405, 416 and 424 of this chapter, entitled to have payment made as 
specified in paragraph (b) of this section.
    (2) The services specified in paragraphs (b)(5) through (b)(14) of 
this section must be furnished by a facility that has in effect a 
provider agreement or other appropriate agreement to participate in 
Medicare.
    (b) Specific rules. Subject to the conditions set forth in paragraph 
(a) of this section, Medicare Part B pays as follows:
    (1) To the individual, or to a physician or other supplier on the 
individual's behalf, for medical and other health services furnished by 
the physician or other supplier.
    (2) To a nonparticipating hospital on the individual's behalf for 
emergency outpatient services furnished by the hospital, in accordance 
with subpart G of part 424 of this chapter.
    (3) To the individual, for emergency outpatient services furnished 
by a nonparticipating hospital, in accordance with Sec. 424.53 of this 
chapter.
    (4) To the individual, for physicians' services and ambulance 
services furnished outside the United States in accordance with 
Sec. 424.53 of this chapter.
    (5) To a provider on the individual's behalf for medical and other 
health services furnished by the provider (or by others under 
arrangements made with them by the provider).

[[Page 291]]

    (6) To a home health agency on the individual's behalf for home 
health services furnished by the home health agency.
    (7) To a clinic, rehabilitation agency, or public health agency on 
the individual's behalf for outpatient physical therapy or speech 
pathology services furnished by the clinic or agency (or by others under 
arrangements made with them by the clinic or agency).
    (8) To a rural health clinic or Federally qualified health center on 
the individual's behalf for rural health clinic or Federally qualified 
health center services furnished by the rural health clinic or Federally 
qualified health center, respectively.
    (9) To an ambulatory surgical center (ASC) on the individual's 
behalf for covered ambulatory surgical center facility services that are 
furnished in connection with surgical procedures performed in an ASC, as 
provided in part 416 of this chapter.
    (10) To a comprehensive outpatient rehabilitation facility (CORF) on 
the individual's behalf for comprehensive outpatient rehabilitation 
facility services furnished by the CORF.
    (11) To a renal dialysis facility, on the individual's behalf, for 
institutional or home dialysis services, supplies, and equipment 
furnished by the facility.
    (12) To a critical access hospital (CAH) on the individual's behalf 
for outpatient CAH services furnished by the CAH.
    (13) To a community mental health center (CMHC) on the individual's 
behalf, for partial hospitalization services furnished by the CMHC (or 
by others under arrangements made with them by the CMHC).
    (14) To an SNF for services (other than those described in 
Sec. 411.15(p)(2) of this chapter) that it furnishes to a resident (as 
defined in Sec. 411.15(p)(3) of this chapter) of the SNF who is not in a 
covered Part A stay.
    (15) To the qualified employer of a physician assistant for 
professional services furnished by the physician assistant and for 
services and supplies furnished incident to his or her services. Payment 
is made to the employer of a physician assistant regardless of whether 
the physician assistant furnishes services under a W-2, employer-
employee employment relationship, or whether the physician assistant is 
an independent contractor who receives a 1099 reflecting the 
relationship. Both types of relationships must conform to the 
appropriate guidelines provided by the Internal Revenue Service. A 
qualified employer is not a group of physician assistants that 
incorporate to bill for their services. Payment is made only if no 
facility or other provider charges or is paid any amount for services 
furnished by a physician assistant.
    (16) To a nurse practitioner or clinical nurse specialist for 
professional services furnished by a nurse practitioner or clinical 
nurse specialist in all settings in both rural and nonrural areas and 
for services and supplies furnished incident to those services. Payment 
is made only if no facility or other provider charges, or is paid, any 
amount for the furnishing of the professional services of the nurse 
practitioner or clinical nurse specialist.
    (17) To a clinical psychologist on the individual's behalf for 
clinical psychologist services and for services and supplies furnished 
as an incident to his or her services.
    (18) To a clinical social worker on the individual's behalf for 
clinical social worker services.
    (19) To a participating HHA, for home health services (including 
medical supplies described in section 1861(m)(5) of the Act, but 
excluding durable medical equipment to the extent provided for in such 
section) furnished to an individual who at the time the item or service 
is furnished is under a plan of care of an HHA (without regard to 
whether the item or service is furnished by the HHA directly, under 
arrangement with the HHA, or under any other contracting or consulting 
arrangement).

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 57 
FR 24981, June 12, 1992; 58 FR 30668, May 26, 1993; 59 FR 6577, Feb. 11, 
1994; 63 FR 20129, Apr. 23, 1998; 63 FR 26308, May 12, 1998; 63 FR 
58909, Nov. 2, 1998; 65 FR 41211, July 3, 2000; 66 FR 39599, July 31, 
2001]

Sec. 410.152  Amounts of payment.

    (a) General provisions--(1) Exclusion from incurred expenses. As 
used in this

[[Page 292]]

section, ``incurred expenses'' are expenses incurred by an individual, 
during his or her coverage period, for covered Part B services, 
excluding the following:
    (i) Expenses incurred for services for which the beneficiary is 
entitled to have payment made under Medicare Part A or would be so 
entitled except for the application of the Part A deductible and 
coinsurance requirements.
    (ii) Expenses incurred in meeting the Part B blood deductible 
(Sec. 410.161).
    (iii) In the case of services payable under a formula that takes 
into account reasonable charges, reasonable costs, customary charges, 
customary (insofar as reasonable) charges, charges related to reasonable 
costs, fair compensation, a pre-treatment prospective payment rate, or a 
standard overhead amount, or any combination of two or more of these 
factors, expenses in excess of any factor taken into account under that 
formula.
    (iv) Expenses in excess of the outpatient mental health treatment 
limitation described in Sec. 410.155.
    (v) In the case of expenses incurred for outpatient physical therapy 
services including speech-language pathology services, the expenses 
excluded are from the incurred expenses under Sec. 410.60(e). In the 
case of expenses incurred for outpatient occupational therapy including 
speech-language pathology services, the expenses excluded are from the 
incurred expenses under Sec. 410.59(e).
    (2) Other applicable provisions. Medicare Part B pays for incurred 
expenses the amounts specified in paragraphs (b) through (k) of this 
section, subject to the following:
    (i) The principles and procedures for determining reasonable costs 
and reasonable charges and the conditions for Medicare payment, as set 
forth in parts 405 (subparts E and X), 413, and 424 of this chapter.
    (ii) The Part B annual deductible (Sec. 410.160).
    (iii) The special rules for payment to health maintenance 
organizations (HMOs), health care prepayment plans (HCPPs), and 
competitive medical plans (CMPs) that are set forth in part 417 of this 
chapter. (A prepayment organization that does not qualify as an HMO, 
CMP, or HCPP is paid in accordance with paragraph (b)(4) of this 
section.)
    (b) Basic rules for payment. Except as specified in paragraphs (c) 
through (h) of this section, Medicare Part B pays the following amounts:
    (1) For services furnished by, or under arrangements made by, a 
provider other than a nominal charge provider, whichever of the 
following is less:
    (i) 80 percent of the reasonable cost of the services.
    (ii) The reasonable cost of, or the customary charges for, the 
services, whichever is less, minus 20 percent of the customary (insofar 
as reasonable) charges for the services.
    (2) For services furnished by, or under arrangements made by, a 
nominal charge provider, 80 percent of fair compensation.
    (3) For emergency outpatient hospital services furnished by a 
nonparticipating hospital that is eligible to receive payment for those 
services under subpart G of part 424 of this chapter, the amount 
specified in paragraph (b)(1) of this section.
    (4) For services furnished by a person or an entity other than those 
specified in paragraphs (b)(1) through (b)(3) of this section, 80 
percent of the reasonable charges or 80 percent of the payment amount 
computed on any other payment basis for the services.
    (c) Amount of payment: Home health services other than durable 
medical equipment (<STRONG>DME</STRONG>). For home health services other than <STRONG>DME</STRONG> 
furnished by, or under arrangements made by, a participating HHA, 
Medicare Part B pays the following amounts:
    (1) For services furnished by an HHA that is a nominal charge 
provider, 100 percent of fair compensation.
    (2) For services furnished by an HHA that is not a nominal charge 
provider, the lesser of the reasonable cost of the services and the 
customary charges for the services.
    (d) Amount of payment: <STRONG>DME</STRONG> furnished as a home health service.
    (1) Basic rule. Except as specified in paragraph (d)(2) of this 
section--
    (i) For <STRONG>DME</STRONG> furnished by an HHA that is a nominal charge provider,

[[Page 293]]

Medicare Part B pays 80 percent of fair compensation.
    (ii) For <STRONG>DME</STRONG> furnished by an HHA that is not a nominal charge 
provider, Medicare Part B pays the lesser of the following:
    (A) 80 percent of the reasonable cost of the service.
    (B) The reasonable cost of, or the customary charge for, the 
service, whichever is less, minus 20 percent of the customary (insofar 
as reasonable) charge for the service.
    (2) Exception. If the <STRONG>DME</STRONG> is used <STRONG>DME</STRONG> purchased by or on behalf of 
the beneficiary at a price at least 25 percent less than the reasonable 
charge for new equipment--
    (i) For used <STRONG>DME</STRONG> furnished by an HHA that is a nominal charge 
provider, Medicare Part B pays 100 percent of fair compensation.
    (ii) For used <STRONG>DME</STRONG> furnished by an HHA that is not a nominal charge 
provider, Medicare Part B pays 100 percent of the reasonable cost of, or 
the customary charge for, the services, whichever is less.
    (e) Amount of payment: Renal dialysis services, supplies, and 
equipment. Effective for services furnished on or after August 1, 1983, 
Medicare Part B pays for the institutional dialysis services specified 
in Sec. 409.250 and the home dialysis services, supplies, and equipment 
specified in Sec. 409.252, as follows:
    (1) Except as provided in paragraph (d)(2) of this section, 80 
percent of the per treatment prospective reimbursement rate established 
under Sec. 413.170 of this chapter, for outpatient maintenance dialysis 
furnished by ESRD facilities approved in accordance with subpart U of 
part 405 of this chapter.
    (2) Exception. If a home dialysis patient elects to obtain home 
dialysis supplies or equipment (or both) from a party other than an 
approved ESRD facility, payment is in accordance with paragraph (b)(4) 
of this section.
    (f) Amount of payment: Rural health clinic and Federally qualified 
health center services. Medicare Part B pays, for services by a 
participating independent rural health clinic or Federally qualified 
health center, 80 percent of the costs determined under subpart X of 
part 405 of this chapter, to the extent those costs are reasonable and 
related to the cost of furnishing rural health clinic or Federally 
qualified health center services or reasonable on the basis of other 
tests specified by CMS.
    (g) Amount of payment: Used durable medical equipment furnished by 
otherthan an HHA. Medicare Part B pays the following amounts for used 
<STRONG>DME</STRONG> purchased by or on behalf of the beneficiary at a price at least 25 
percent less than the reasonable charge for comparable new equipment:
    (1) For used <STRONG>DME</STRONG> furnished by, or under arrangements made by, a 
nominal charge provider, 100 percent of fair compensation.
    (2) For used <STRONG>DME</STRONG> furnished by or under arrangements made by a 
provider that is not a nominal charge provider, 100 percent of the 
reasonable cost of the service or the customary charge for the service, 
whichever is less.
    (3) For used <STRONG>DME</STRONG> furnished by other than a provider, 100 percent of 
the reasonable charge.
    (h) Amount of payment: Pneumococcal vaccine. Medicare Part B pays 
for pneumococcal vaccine and its administration as follows:
    (1) For services furnished by a nominal charge provider, 100 percent 
of fair compensation.
    (2) For services furnished by a provider that is not a nominal 
charge provider, the reasonable cost of the services or the customary 
charge for the service, whichever is less.
    (3) For services furnished by other than a provider, a rural health 
clinic or a Federally qualified health center, 100 percent of the 
reasonable charge.
    (4) For services furnished by a rural health clinic or a Federally 
qualified health center, 100 percent of the reasonable cost.
    (i) Amount of payment: ASC facility services. For ASC facility 
services that are furnished in connection with the surgical procedures 
specified in part 416 of this chapter, Medicare Part B pays 80 percent 
of a standard overhead amount, as specified in Sec. 416.120(c) of this 
chapter.&lt;SUP&gt;1&lt;/SUP&gt;
---------------------------------------------------------------------------

    \1\ For services furnished before July 1, 1987, Medicare Part B paid 
100 percent of the standard amount.

---------------------------------------------------------------------------

[[Page 294]]

    (j) Amount of payment: services of Federally funded health 
facilities prior to October 1, 1991. Medicare Part B pays 80 percent of 
charges related to the reasonable costs that a Federally funded health 
facility incurs in furnishing the services. See Sec. 411.8(b)(6) of this 
chapter.
    (k) Amount of payment: Outpatient CAH services. (1) Payment for CAH 
outpatient services is the reasonable cost of the CAH in providing these 
services, as determined in accordance with section 1861(v)(1)(A) of the 
Act, with Sec. 413.70(b) and (c) of this chapter, and with the 
applicable principles of cost reimbursement in part 413 and in part 415 
of this chapter.
    (2) Payment for CAH outpatient services is subject to the applicable 
Medicare Part B deductible and coinsurance amounts, except as described 
in Sec. 413.70(b)(2)(iii) of this chapter, with Part B coinsurance being 
calculated as 20 percent of the customary (insofar as reasonable) 
charges of the CAH for the services.
    (l) Amount of payment: Flu vaccine. Medicare Part B pays 100 percent 
of the Medicare allowed charge.

[51 FR 41339, Nov. 14, 1986; 52 FR 4499, Feb. 12, 1987, as amended at 53 
FR 6648, Mar. 2, 1988; 56 FR 2138, Jan. 22, 1991; 56 FR 8841, Mar. 1, 
1991; 57 FR 24981, June 12, 1992; 58 FR 30668, May 26, 1993; 59 FR 
63462, Dec. 8, 1994; 62 FR 46025, Aug. 29, 1997; 63 FR 20129, Apr. 23, 
1998; 63 FR 26357, May 12, 1998; 63 FR 35066, June 26, 1998; 63 FR 
58910, Nov. 2, 1998; 65 FR 47047, 47105, Aug. 1, 2000; 66 FR 32192, June 
13, 2001]

Sec. 410.155  Outpatient mental health treatment limitation.

    (a) Limitation. Only 62\1/2\ percent of the expenses incurred for 
services subject to the limit as specified in paragraph (b) of this 
section are considered incurred expenses under Medicare Part B when 
determining the amount of payment and deductible under Secs. 410.152 and 
410.160, respectively.
    (b) Application of the limitation--(1) Services subject to the 
limitation. Except as specified in paragraph (b)(2) of this section, the 
following services are subject to the limitation if they are furnished 
in connection with the treatment of a mental, psychoneurotic, or 
personality disorder (that is, any condition identified by a diagnosis 
code within the range of 290 through 319) and are furnished to an 
individual who is not an inpatient of a hospital:
    (i) Services furnished by physicians and other practitioners, 
whether furnished directly or as an incident to those practitioners' 
services.
    (ii) Services provided by a CORF.
    (2) Services not subject to the limitation. Services not subject to 
the limitation include the following:
    (i) Services furnished to a hospital inpatient.
    (ii) Brief office visits for the sole purpose of monitoring or 
changing drug prescriptions used in the treatment of mental, 
psychoneurotic, or personality disorders.
    (iii) Partial hospitalization services not directly provided by a 
physician.
    (iv) Diagnostic services, such as psychological testing, that are 
performed to establish a diagnosis.
    (v) Medical management, as opposed to psychotherapy, furnished to a 
patient diagnosed with Alzheimer's disease or a related disorder.
    (c) Examples. (1) A clinical psychologist submitted a claim for $200 
for outpatient treatment of a beneficiary's mental disorder. The 
Medicare approved amount was $180. Since clinical psychologists must 
accept assignment, the beneficiary is not liable for the $20 in excess 
charges. The beneficiary previously satisfied the $100 annual Part B 
deductible. The limitation reduces the amount of incurred expenses to 
62\1/2\ percent of the approved amount. After subtracting any unmet 
deductible, Medicare pays 80 percent of the remaining incurred expenses. 
Medicare payment and beneficiary liability are computed as follows:

------------------------------------------------------------------------

------------------------------------------------------------------------
1. Actual charges.............................................   $200.00
2. Medicare approved amount...................................    180.00
3. Medicare incurred expenses (0.625 x line 2)................    112.50
4. Unmet deductible...........................................      0.00
5. Remainder after subtracting deductible (line 3 minus line      112.50
 4)...........................................................
6. Medicare payment (0.80 x line 5)...........................     90.00
7. Beneficiary liability (line 2 minus line 6)................     90.00
------------------------------------------------------------------------

    (2) A clinical social worker submitted a claim for $135 for 
outpatient treatment of a beneficiary's mental disorder. The Medicare 
approved amount was $120. Since clinical social workers

[[Page 295]]

must accept assignment, the beneficiary is not liable for the $15 in 
excess charges. The beneficiary previously satisfied $70 of the $100 
annual Part B deductible, leaving $30 unmet.

------------------------------------------------------------------------

------------------------------------------------------------------------
1. Actual charges.............................................   $135.00
2. Medicare approved amount...................................    120.00
3. Medicare incurred expenses (0.625 x line 2)................     75.00
4. Unmet deductible...........................................     30.00
5. Remainder after subtracting deductible (line 3 minus line       45.00
 4)...........................................................
6. Medicare payment (0.80 x line 5)...........................     36.00
7. Beneficiary liability (line 2 minus line 6)................     84.00
------------------------------------------------------------------------

    (3) A physician who did not accept assignment submitted a claim for 
$780 for services in connection with the treatment of a mental disorder 
that did not require inpatient hospitalization. The Medicare approved 
amount was $750. Because the physician did not accept assignment, the 
beneficiary is liable for the $30 in excess charges. The beneficiary had 
not satisfied any of the $100 Part B annual deductible.

------------------------------------------------------------------------

------------------------------------------------------------------------
1. Actual charges.............................................   $780.00
2. Medicare approved amount...................................    750.00
3. Medicare incurred expenses (0.625 x line 2)................    468.75
4. Unmet deductible...........................................    100.00
5. Remainder after subtracting deductible (line 3 minus line      368.75
 4)...........................................................
6. Medicare payment (0.80 x line 5)...........................    295.00
7. Beneficiary liability (line 1 minus line 6)................    485.00
------------------------------------------------------------------------

    (4) A beneficiary's only Part B expenses during 1995 were for a 
physician's services in connection with the treatment of a mental 
disorder that initially required inpatient hospitalization. The 
remaining services were furnished on an outpatient basis. The 
beneficiary had not satisfied any of the $100 annual Part B deductible 
in 1995. The physician, who accepted assignment, submitted a claim for 
$780. The Medicare-approved amount was $750. The beneficiary incurred 
$350 of the approved amount while a hospital inpatient and incurred the 
remaining $400 of the approved amount for outpatient services. Only $400 
of the approved amount is subject to the 62\1/2\ percent limitation 
because the statutory limitation does not apply to services furnished to 
hospital inpatients.

------------------------------------------------------------------------

------------------------------------------------------------------------
1. Actual charges.............................................   $780.00
2. Medicare approved amount...................................   $750.00
  2A. Inpatient portion.......................................      $350
  2B. Outpatient portion......................................      $400
3. Medicare incurred expenses.................................   $600.00
  3A. Inpatient portion.......................................      $350
  3B. Outpatient portion (0.625 x line 2B)....................      $250
4. Unmet deductible...........................................   $100.00
5. Remainder after subtracting deductible (line 3 minus line     $500.00
 4)...........................................................
6. Medicare payment (0.80 x line 5)...........................   $400.00
7. Beneficiary liability (line 2 minus line 6)................   $350.00
------------------------------------------------------------------------


[63 FR 20129, Apr. 23, 1998]

Sec. 410.160  Part B annual deductible.

    (a) Basic rule. Except as provided in paragraph (b) of this section, 
incurred expenses (as defined in Sec. 410.152) are subject to, and count 
toward meeting the annual deductible.
    (b) Exceptions. Expenses incurred for the following services are not 
subject to the Part B annual deductible and do not count toward meeting 
that deductible:
    (1) Home health services.
    (2) Pneumococcal vaccines and their administration.
    (3) Federally qualified health center services.
    (4) ASC facility services furnished before July 1987 and physician 
services furnished before April 1988 that met the requirements for 
payment of 100 percent of the reasonable charges.
    (5) Screening mammography services as described in Sec. 410.34 (c) 
and (d).
    (6) Screening pelvic examinations as described in Sec. 410.56.
    (c) Application of the Part B annual deductible. (1) Before payment 
is made under Sec. 410.152, an individual's incurred expenses for the 
calendar year are reduced by the Part B annual deductible.
    (2) The Part B annual deductible is applied to incurred expenses in 
the order in which claims for those expenses are processed by the 
Medicare program.
    (3) Only one Part B annual deductible may be imposed for any 
calendar year and it may be met by any combination of expenses incurred 
in that year.
    (d) Special rule for services reimbursable on a formula basis. (1) 
In applying the formula that takes into account reasonable costs, 
customary charges, and customary (insofar as reasonable)

[[Page 296]]

charges, and is used to determine payment for services furnished by a 
provider that is not a nominal charge provider, the Medicare 
intermediary takes the following steps:
    (i) Reduces the customary charges for the services by an amount 
equal to any unmet portion of the deductible for the calendar year, in 
accordance with paragraph (b) of this section. (The amount of this 
reduction is considered to be the amount of the deductible that is met 
on the basis of the services to which it is applied.)
    (ii) Determines 20 percent of any remaining portion of the customary 
(insofar as reasonable) charge.
    (iii) Determines the lesser of the reasonable cost of the services 
and the customary charges for the services.
    (iv) Reduces the amount determined under paragraph (c)(1)(iii) of 
this section by the sum of the reduction made under paragraph (c)(1)(i) 
of this section and the amount determined under parargaph (c)(1)(ii) of 
this section.
    (v) Reduces the reasonable cost of the services by the amount of the 
reduction made under paragraph (c)(1)(i) of this section and multiplies 
the result by 80 percent.
    (2) In accordance with Sec. 410.152(b)(1), the amount payable is the 
amount determined under paragraph (c)(1)(iv) of this section, or the 
amount determined under paragraph (c)(1)(v) of this section, whichever 
is less.
    (e) Special rule for services of an independent rural health clinic. 
Application of the Part B annual deductible to rural health clinic 
services is in accordance with Sec. 405.2425(b)(2) of this chapter.
    (f) Amount of the Part B annual deductible. (1) Beginning with 
expenses for services furnished during calendar year 1982, the Part B 
annual deductible is $75.
    (2) From 1973 through 1981, the deductible was $60.
    (3) From 1966 through 1972, the deductible was $50.
    (g) Carryover of Part B annual deductible. For calendar years before 
1982, the Part B annual deductible was reduced by the amount of expenses 
incurred during the last quarter of the preceding year that was applied 
to meet the deductible for that preceding year. Example: If $20 of 
expenses incurred in November 1980 was used to meet the 1980 deductible, 
the 1981 deductible was reduced to $40 ($60-$20).
    (h) Examples of application of the annual deductible. (1) Mr. A 
submitted claims for the following expenses incurred during 1982: $20 
for services furnished in March by physician X; $30 for services 
furnished in April by physician Y; $50 for services furnished in June by 
physician Z, for a total of $100. The carrier determined that the 
charges as submitted were the reasonable charges. The first $75 of 
expenses for which claims were processed is applied to meet the $75 
deductible for that year. Medicare Part B pays 80 percent of the 
remaining $25, or $20.
    (2) Mr. B submitted a claim that included a $25 charge by a doctor 
for an examination to prescribe a hearing aid and an $80 charge for 
office surgery. This was the first claim relating to Mr. B's medical 
expenses processed in the calendar year. The carrier disallowed the $25 
charge because the type of examination is not covered by Medicare. The 
carrier reduced the $80 surgery charge to a reasonable charge of $40. 
Only the $40 reasonable charge for covered services will count toward 
meeting Mr. B's deductible. Since the remainder of the surgery charge 
constitutes and excess over the reasonable charge, it cannot be applied 
to satisfy Mr. B's deductible.
    (3) Mr. C became entitled to Medicare Part B <STRONG>benefits</STRONG> on July 1, 
1982. He incurred expenses of $200 in July, August, and September. The 
carrier determined that the changes as submitted were reasonable. Even 
though Mr. C was entitled to <STRONG>benefits</STRONG> for only half the year, he must 
meet the full $75 deductible. Thus, $75 of this expense constitutes Mr. 
C's deductible. Medicare would pay $100, which is 80 percent of the 
remaining $125.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 8842 and 8852, Mar. 1, 
1991; 57 FR 24981, June 12, 1992; 62 FR 59101, Oct. 31, 1997]

Sec. 410.161  Part B blood deductible.

    (a) General rules. (1) As used in this section, packed red cells 
means the red blood cells that remain after plasma is separated from 
whole blood.

[[Page 297]]

    (2) A unit of packed red cells is treated as the equivalent of a 
pint of whole blood, which in this section is referred to as a unit of 
whole blood.
    (3) Medicare does not pay for the first 3 units of whole blood or 
units of packed red cells that are furnished under Part A or Part B in a 
calendar year. The Part B blood deductible is reduced to the extent that 
a blood deductible has been applied under Part A.
    (4) The blood deductible does not apply to other blood components 
such as platelets, fibrinogen, plasma, gamma globulin and serum albumin, 
or to the costs of processing, storing, and administering blood.
    (5) The blood deductible is in addition to the Part B annual 
deductible specified in Sec. 410.160.
    (b) Beneficiary's responsibility for the first 3 units of blood. (1) 
The beneficiary is responsible for the first three units of whole blood 
or packed red cells received during a calendar year.
    (2) If the blood is furnished by a hospital or CAH, the rules set 
forth in Sec. 409.87 (b), (c), and (d) of this chapter apply.
    (3) If the blood is furnished by a physician, clinic, or other 
supplier that has accepted assignment of Medicare <STRONG>benefits</STRONG>, or claims 
payment under Sec. 424.64 of this chapter because the beneficiary died 
without assigning <STRONG>benefits</STRONG>, the supplier may charge the beneficiary the 
reasonable charge for the first 3 units, to the extent that those units 
are not replaced.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 56 
FR 8852, Mar. 1, 1991; 58 FR 30668, May 26, 1993]

Sec. 410.163  Payment for services furnished to kidney donors.

    Notwithstanding any other provisions of this chapter, there are no 
deductible or coinsurance requirements with respect to services 
furnished to an individual who donates a kidney for transplant surgery.

Sec. 410.165  Payment for rural health clinic services and ambulatory 
          surgical center services: Conditions.

    (a) Medicare Part B pays for covered rural health clinic and 
Federally qualified health center services if--
    (1) The services are furnished in accordance with the requirements 
of subpart X of part 405 of this chapter and subpart A of part 491 of 
this chapter; and
    (2) The clinic or center files a written request for payment on the 
form and in the manner prescribed by CMS.
    (b) Medicare Part B pays for covered ambulatory surgical center 
(ASC) services if--
    (1) The services are furnished in accordance with the requirements 
of part 416 of this chapter; and
    (2) The ASC files a written request for payment on the form and in 
the manner prescribed by CMS.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 24981, June 12, 1992]

Sec. 410.170  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 
          facility (CORF) services: Conditions.

    Payment under Medicare Part B, for home health services, for medical 
and other health services, or for CORF services, may be made to the 
provider or facility only if the following conditions are met:
    (a) Request for payment. A written request for payment is filed by 
or on behalf of the individual to whom the services were furnished.
    (b) Physician certification. (1) For home health services, a 
physician provides certification and recertification in accordance with 
Sec. 424.22 of this chapter.
    (2) For medical and other health services, a physician provides 
certification and recertification in accordance with Sec. 424.24 of this 
chapter.
    (3) For CORF services, a physician provides certification and 
recertification in accordance with Sec. 424.27 of this chapter.
    (c) In the case of home dialysis support services described in 
Sec. 410.52, the services are furnished in accordance with a written 
plan prepared and periodically reviewed by a team that includes the 
patient's physician and other professionals familiar with the

[[Page 298]]

patient's condition as required by Sec. 405.2137(b)(3) of this chapter.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988]

Sec. 410.172  Payment for partial hospitalization services in CMHCs: 
          Conditions.

    Medicare Part B pays for partial hospitalization services furnished 
in a CMHC on behalf of an individual only if the following conditions 
are met:
    (a) The CMHC files a written request for payment on the CMS form 
1450 and in the manner prescribed by CMS; and
    (b) The services are furnished in accordance with the requirements 
described in Sec. 410.110.

[59 FR 6578, Feb. 11, 1994]

Sec. 410.175  Alien absent from the United States.

    (a) Medicare does not pay Part B <STRONG>benefits</STRONG> for services furnished to 
an individual who is not a citizen or a national of the United States if 
those services are furnished in any month for which the individual is 
not paid monthly social security cash <STRONG>benefits</STRONG> (or would not be paid if 
he or she were entitled to those <STRONG>benefits</STRONG>) because he or she has been 
outside the United States continuously for 6 full calendar months.
    (b) Payment of <STRONG>benefits</STRONG> resumes with services furnished during the 
first full calendar month the alien is back in the United States.

[53 FR 6634, Mar. 2, 1988]



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