Coverage Summary
Radiologic Diagnostic Procedures
Policy Number: R-002
Products: UnitedHealthcare Medicare Advantage Plans
Approved by: UnitedHeatlhcare Medicare Benefit Interpretation Committee
Original Approval Date: 04/02/2008
Last Review Date: 05/17/2016
Related Medicare Advantage Policy Guidelines:
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Computed Tomography (NCD 220.1)
Infrared Therapy Devices (NCD 270.6)
Magnetic Resonance Imaging (NCD 220.2)
Magnetic Resonance Spectroscopy (NCD 220.2.1)
Mammograms (NCD 220.4)
Percutaneous Image-Guided Breast Biopsy (NCD 220.13)
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Portable Hand-Held X-Ray Instrument (NCD 220.10)
Single Photon Emission Computed Tomography (SPECT)
(NCD 220.12)
Thermography (NCD 220.11)
Transillumination Light Scanning or Diaphanography
(NCD 30.9)
Ultrasound Diagnostic Procedures (NCD 220.5)
This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and
unauthorized copying, use, and distribution are prohibited. This information is intended to serve only as a general reference
resource and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on this
information in making health care decisions. Physicians and patients must exercise their independent clinical discretion and
judgment in determining care. Each benefit plan contains its own specific provisions for coverage, limitations, and exclusions
as stated in the Member’s Evidence of Coverage (EOC)/Summary of Benefits (SB). If there is a discrepancy between this
policy and the member’s EOC/SB, the member’s EOC/SB provision will govern. The information contained in this document is
believed to be current as of the date noted.
The benefit information in this Coverage Summary is based on existing national coverage policy, however, Local Coverage
Determinations (LCDs) may exist and compliance with these policies is required where applicable.
INDEX TO COVERAGE SUMMARY
I.
COVERAGE
1. Diagnostic radiological services (inpatient or outpatient)
a. Diagnostic X-rays
b. X-Ray, Radium, and Radioactive Isotope Therapy
c. Screening Mammogram
d. Obstetrical Ultrasound
e. Bone Density Studies
f. Diagnostic Mammogram
g. Ultrasonography/Ultrasound
h.
i.
j.
k.
l.
m.
n.
Computerized Tomography (CT scan)
Single Photon Emission Computed Tomography (SPECT)
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Angiography (MRA)
Ultra Fast or Multislice CT
Proton Emission Tomography
Percutaneous Image-guided Breast Biopsy
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2.
II.
III.
IV.
I.
o. Portable Hand-Held X-ray Instrument
Examples of radiologic procedures that are not covered
a. Thermography
b. Infrared Devices
c. Ultra Fast CT Scanning for screening purposes
d. Experimental or Investigational Procedures
e. Transillumination Light Scanning or Diaphanography
f. Magnetic Resonance Spectroscopy
DEFINITIONS
REFERENCES
REVISION HISTORY
COVERAGE
Coverage Statement: Diagnostic radiologic procedures are covered when Medicare criteria are met.
Note: Radiology prior authorization programs exist for some markets for MRIs, MRAs, PET scans
and nuclear medicine studies. Reference materials are available at Medicare Advantage Evidence
Based Clinical Guidelines - Imaging 2016. (Accessed April 27, 2016)
Guidelines/Notes:
1. Diagnostic radiological services (inpatient or outpatient) used for screening, detection or
treatment of disease, are covered when such services are determined to be reasonable and
necessary. Examples include, but are not limited to:
a.
Diagnostic X-rays
See the following sections of Medicare Benefit Policy Manual Chapter 15 – Covered
Medical and Other Health Services:
 §10 - Supplementary Medical Insurance (SMI) Provisions. (Accessed April 27,
2016)
 §80 - Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other
Diagnostic Tests. ( Accessed April 27, 2016)
 §80.4 Coverage of Portable X-Ray Services Not Under the Direct Supervision of a
Physician. (Accessed April 27, 2016)
Local Coverage Determinations (LCDs) exist for and compliance with these LCDs is
required where applicable. See the following LCDs at http://www.cms.gov/medicarecoverage-database/overview-and-quick-search.aspx:
o Radiologic Examination., Chest
o Chest X-ray Policy
o Sinus X-rays
(Accessed April 27, 2016)
b.
X-Ray, Radium, and Radioactive Isotope Therapy
See the Medicare Benefit Policy Manual Chapter 15 – Covered Medical and Other
Health Services §90 X-Ray, Radium and Radioactive Isotope. (Accessed April 27, 2016)
c.
Screening Mammogram
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See the Coverage Summary for Preventive Health Services and Procedures
d.
Obstetrical Ultrasound
See the NCD for Ultrasound Diagnostic Procedures (220.5). (Accessed April 27, 2016)
Also see the Coverage Summary for Maternity and Newborn Care.
e.
Bone Density Studies
Bone density studies are covered when criteria are met; see the Coverage Summary for
Bone Density Studies/Bone Mass Measurements.
f.
Diagnostic Mammogram
See the NCD for Mammograms (220.4). (Accessed April 27, 2016)
Local Coverage Determinations (LCDs) exist and compliance with these policies is
required where applicable. See the LCDs for Breast Imaging Mammography/Breast
Echography (Sonography)/Breast MRI/Ductography and the LCDs for Screening and
Diagnostic Mammography at http://www.cms.gov/medicare-coveragedatabase/overview-and-quick-search.aspx. (Accessed April 27, 2016)
g.
Ultrasonography/Ultrasound
See the NCD for Ultrasound Diagnostic Procedures (220.5). (Accessed April 27, 2016)
Local Coverage Determinations (LCDs) exist and compliance with these LCDs is
required where applicable. See the LCDs for Bone Mass Measurement, Bone Mineral
Density Studies, Nonvascular Extremity Ultrasound, Transrectal Ultrasound, at
http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx.
(Accessed April 27, 2016)
h.
Computerized Tomography (CT scan)*
See the NCD for Computerized Tomography (220.1). (Accessed April 27, 2016)
i.
Single Photon Emission Computed Tomography (SPECT)*
See the NCD for Single Photon Emission Computed Tomography (SPECT) (220.12).
(Accessed April 27, 2016)
j.
Magnetic Resonance Imaging (MRI)*
See the NCD for Magnetic Resonance Imaging (220.2). (Accessed April 27, 2016)
Notes:
 Coverage is limited to MRI units that have received FDA premarket approval, and
such units must be operated within the parameters specified by the approval. In
addition, the services must be reasonable and necessary for the diagnosis or
treatment of the specific patient involved.
 CMS has determined that imaging of cortical bone and calcifications, and
procedures involving spatial resolution of bone and calcifications, are not
considered reasonable and necessary indications and are therefore, non-covered.
 All other uses of MRI for which CMS has not specifically indicated coverage or noncoverage continue to be eligible for coverage through individual local contractor
discretion.
 The MRI is not covered when the following patient-specific contraindications
are present:
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o
o
o
MRI is not covered for patients with cardiac pacemakers or with metallic clips
on vascular aneurysms unless the Medicare beneficiary meets the provisions of
the following exceptions:
Effective July 7, 2011, the contraindications will not apply to pacemakers when
used according to the FDA-approved labeling in an MRI environment, OR
Effective February 24, 2011, CMS believes that the evidence is promising
although not yet convincing that MRI will improve patient health outcomes if
certain safeguards are in place to ensure that the exposure of the device to an
MRI environment adversely affects neither the interpretation of the MRI result
nor the proper functioning of the implanted device itself. We believe that
specific precautions (as listed below) could maximize benefits of MRI exposure
for beneficiaries enrolled in clinical trials designed to assess the utility and
safety of MRI exposure. Therefore, CMS determines that MRI will be covered
by Medicare when provided in a clinical study under section 1862(a)(1)(E)
(consistent with section 1142 of the Act) through the Coverage with Study
Participation (CSP) form of Coverage with Evidence Development (CED) (see
the NCD for Magnetic Resonance Imaging (220.2) for further information)
(Accessed April 27, 2016)
The list of Medicare approved clinical trials is available at
http://www.cms.gov/Medicare/Coverage/Coverage-with-EvidenceDevelopment/MRA_MRI.html. (Acccesed April 27, 2016)
For payment rules for NCDs requiring CED, see the Coverage Summary for
Experimental Procedures and Items, Investigational Devices and Clinical
Trials.

Local Coverage Determinations (LCDs) exist for MRI and compliance with these
policies is required where applicable. These LCDs are available at
http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx.
(Accessed April 27, 2016)
 For states with no LCDs, for uses of MRI not specifically addressed by the MRI
NCD (220.2), refer to the following for coverage guidelines:
o For regions involved in the Radiology Prior Auth Program, see the Medicare
Advantage Evidence Based Clinical Guidelines - Imaging 2016 for coverage
guidelines.
o For regions not involved in the Radiology Prior Auth Program, see the
nationally recognized guidelines, i.e., MCG™ Care Guidelines.
k.
Magnetic Resonance Angiography (MRA)*
See the NCD for Magnetic Resonance Imaging (220.2). (Accessed April 27, 2016)
Notes:
 Local Coverage Determinations (LCDs) exist for MRA and compliance with these
policies is required where applicable. These LCDs are available at
http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx.
(Accessed April 27, 2016)
 For states with no LCDs, for uses of MRA not specifically addressed by the MRI
NCD (220.2), refer to the following for coverage guidelines:
o For regions involved in the Radiology Prior Auth Program see the Medicare
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Advantage Evidence Based Clinical Guidelines - Imaging 2016 for coverage
guidelines.
o For regions not involved in the Radiology Prior Auth Program, see the
nationally recognized guidelines, i.e., MCG™ Care Guidelines.
 On June 3, 2010, CMS made the determination that the existence of a separate NCD
for MRA was unnecessary and moved/merged the MRA NCD 220.3 to the MRI NCD
220.2, and allowed the local Medicare contractors to cover (or not cover) all
indications of MRA (and MRI) that are not specifically nationally covered or
nationally non-covered. The CMS decision memo is available at
http://www.cms.gov/transmittals/downloads/R123NCD.pdf. (Accessed April 27, 2016)
l.
Ultra Fast or Multislice CT*
Ultra Fast or Multislice CT is covered when criteria are met. See the Coverage Summary
for Computed Tomographic Angiography (CTA)/Electron Beam Computed Tomography
(EBCT) of the Chest.
m.
Proton Emission Tomography
Proton Emission Tomography* is covered when criteria are met; see the Coverage
Summary for Positron Emission Tomography (PET)/Combined PET-CT (Computed
Tomography) for coverage criteria and information.
n.
Percutaneous Image-guided Breast Biopsy
Percutaneous image-guided breast biopsy is a method of obtaining a breast biopsy
through a percutaneous incision by employing image guidance systems. Image guidance
systems may be either ultrasound or stereotactic.
The Breast Imaging Reporting and Data System (or BIRADS system) employed by the
American College of Radiology provides a standardized lexicon with which radiologists
may report their interpretation of a mammogram. The BIRADS grading of mammograms
is as follows: Grade I-Negative, Grade II-Benign finding, Grade III-Probably benign,
Grade IV-Suspicious abnormality, and Grade V-Highly suggestive of malignant
neoplasm.
Non-Palpable Breast Lesions
Medicare covers percutaneous image-guided breast biopsy using stereotactic or
ultrasound imaging for a radiographic abnormality that is non-palpable and is graded as a
BIRADS III, IV, or V.
Palpable Breast Lesions
Medicare covers percutaneous image guided breast biopsy using stereotactic or
ultrasound imaging for palpable lesions that are difficult to biopsy using palpation alone.
(Note: The treating physician has the discretion to decide what types of palpable lesions
are difficult to biopsy using palpation.)
See the NCD for Percutaneous Guided Breast Biopsy (220.13). (Accessed April 27, 2016)
o.
Portable Hand-Held X-ray Instrument
Portable Hand-Held X-ray Instrument is a light weight, low intensity X-ray imaging
portable hand-held device which uses a low level isotope as its penetrating energy source.
It can picture any part of the human anatomy which can be inserted in the space between
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the energy source and the viewing mechanism. The device can be useful in making an
immediate diagnosis in the following settings: isolated areas, accident scenes, sports
events and emergency rooms. It is also useful in the following instances where
fluoroscopy would ordinarily be used: localization of foreign bodies, selected surgical
procedures and the evaluation of premature or low birth weight infants.
The use of the portable hand-held X-ray instrument as an imaging device is covered
under Medicare. (Note: Portable hand-held X-ray instrument should be reimbursed as
part of the physician's professional service, and no additional charge should be
allowed.).
See the NCD for Portable Hand-Held X-ray Instrument (220.10). (Accessed April 27,
2016)
*Radiology prior authorization programs exist for some markets for MRIs, MRAs, PET scans and
nuclear medicine studies. Reference materials are available at the Medicare Advantage Evidence
Based Clinical Guidelines - Imaging 2016.
2.
The following are examples of radiologic procedures that are not covered. This is not an
exhaustive list of non-covered radiologic procedures. Any test that is not reasonable or
necessary to diagnose, treat or screen for an illness or injury is not covered.
a.
Thermography
See the NCD for Thermography NCD (220.11). (Accessed April 27, 2016)
b.
Infrared Devices
See the NCD for Infrared Therapy Devices (270.6). (Accessed April 27, 2016)
c.
UltraFast CT Scanning for screening purposes
See the Coverage Summary for Gastroesophageal and Gastrointestinal (GI) Services and
Procedures and the Coverage Summary for Computed Tomographic Angiography
(CTA)/Electron Beam Computed Tomography (EBCT) of the Chest.
Note: This is never covered for screening, i.e., in the absence of signs, symptoms or
disease.
d.
Experimental or Investigational Procedures
See the Coverage Summary for Experimental Procedures and Items, Investigational
Devices and Clinical Trials
II.
e.
Transillumination Light Scanning or Diaphanography
See the NCD for Transillumination Light Scanning and Diaphanography (30.9).
(Accessed April 27, 2016)
f.
Magnetic Resonance Spectroscopy
See the NCD for Magnetic Resonance Spectroscopy (MRS) (220.2.1). (Accessed April 27,
2016)
DEFINITIONS
Diagnostic Services: A service is "diagnostic" if it is an examination or procedure to which the
patient is subjected, or which is performed on materials derived from a hospital outpatient, to obtain
information to aid in the assessment of a medical condition or the identification of a disease. Among
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these examinations and tests are diagnostic laboratory services such as hematology and chemistry,
diagnostic x-rays, isotope studies, EKGs, pulmonary function studies, thyroid function tests,
psychological tests, and other tests given to determine the nature and severity of an ailment or injury.
See the Medicare Benefit Policy Manual, Chapter 6, §20.4.1 Diagnostic Services Defined at
http://www.cms.gov/manuals/Downloads/bp102c06.pdf. (Accessed April 27, 2016)
III.
REFERENCES
See above
IV.
REVISION HISTORY
05/17/2016
Annual review with the following updates:
 Guideline 1.f (Diagnostic Mammogram) – Deleted reference to the “Diagnostic
Mammography” LCD and added reference to the LCDs for Breast Imaging
Mammography/Breast Echography (Sonography)/Breast MRI/Ductography.
 Guideline 1.g (Ultrasonography/Ultrasound) - Deleted reference to the “Diagnostic
Mammography” LCD and added reference to the LCDs for Breast Imaging
Mammography/Breast Echography (Sonography)/Breast MRI/Ductography.
 Guideline 2.c (UltraFast CT Scanning for screening purposes) – Added cross
reference to the “Computed Tomographic Angiography (CTA)/Electron Beam
Computed Tomography (EBCT) of the Chest” coverage summary.
06/16/2015
Annual review with the following updates:
 Updated reference link to the UnitedHealthcare Medicare Solutions Evidence
Based Clinical Guidelines Radiology
 Guideline 1.d (Obstetrical Ultrasound) - Added reference link to the NCD for
Ultrasound Diagnostic Procedures (220.5)
 Guideline 2.c (Ultra Fast CT Scanning for screening purposes) - Added reference
link to the Coverage Summary for Gastroesophageal and Gastrointestinal (GI)
Services and Procedures
04/21/2015
Re-review with the following updates:
 NCD 220.7 Xenon Scan and NCD 220.8 Nuclear Radiology Procedure were retired.
Any references to these NCDs will be deleted.
 Guideline #1.j (Magnetic Resonance Imaging)
o Added reference link to the list of Medicare approved clinical trials.
o Added reference link to the Coverage Summary for Experimental Procedures
and Items, Investigational Devices and Clinical Trials for payment rules for
NCDs requiring CED.
04/01/2015
Replaced references to “Milliman Care Guidelines” with “MCG™ Care Guidelines”
06/20/2014
Annual review with the following updates:
 Guideline #1.a Diagnostic X-rays
o Changed section from “Standard X-rays/plain films” to “Diagnostic X-rays”
o Added the reference to the Medicare Benefit Policy Manual, Chapter 15, §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other
Diagnostic Tests
o Deleted the reference to the Medicare Benefit Policy Manual, Chapter 15, §90
X-Ray, Radium and Radioactive Isotope
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
06/24/2013
06/18/2012
06/30/2011
Guideline #1.b X-Ray, Radium, and Radioactive Isotope Therapy - Added as
separate section (from Guideline #1.a)
 Guideline #1.c Intravenous Pyelogram (IVP) - Deleted; no CMS reference
available; falls under #1.a Diagnostic X-rays above
 Guideline #1.d Kidney, Ureter and Bladder (KUB) X-ray - Deleted; no CMS
reference avaiable; falls under #1.a Diagnostic X-rays above
 Guideline #1.n Invasive Radiological Procedures - Deleted; no CMS reference
available; falls under #1.a Diagnostic X-rays above
 Guideline #1.o Percutaneous Image-guided Breast Biopsy
o Added the definition of Percutaneous image-guided breast biopsy from the
Definition section (based on the reference NCD)
o Added language based on the reference NCD to indicate:
 Non-Palpable Breast Lesions
Medicare covers percutaneous image-guided breast biopsy using
stereotactic or ultrasound imaging for a radiographic abnormality that is
non-palpable and is graded as a BIRADS III, IV, or V.
 Palpable Breast Lesions
Medicare covers percutaneous image guided breast biopsy using
stereotactic or ultrasound imaging for palpable lesions that are difficult to
biopsy using palpation alone.
 Guideline #1.p Portable Hand-Held X-ray Instrument
o Added the definition of Portable Hand-Held X-ray Instrument from the
Definition section based on the reference NCD
 Guideline #1.q Xenon Scan
o Added language based on the reference NCD to indicate:
 Program payment may be made for this diagnostic procedure which
involves perfusion lung imaging with 133 xenon. However, review for
evidence of abuse which might include absence of reasonable indications,
inappropriate sequence, or excessive number or kinds of procedures used in
the care of individual patients.
 Definitions
o Moved to Section I the definition of:
 Portable Hand Held X-ray Equipment
 Percutaneous Image Guided Breast Biopsy
o Deleted definition of Transillumination Light (no CMS reference available)
Annual review; no updates
 Guidelines #1.k Magnetic Resonance Imaging (MRI)
o Updated to include noncoverage language for MRI with specific
contraindications (based on MRI NCD 220.2)
o Updated the reference/link to the UnitedHealthcare Physician Guidelines
Evidenced Based regarding Imaging
 Guidelines #1.l Magnetic Resonance Angiography (MRA)
o updated the reference/link to the UnitedHealthcare Physician Guidelines
Evidenced Based regarding Imaging.
 Deleted the section for Intravascular Coronary Ultrasound
 Moved to the CS for Cardiovascular Diagnostic Procedures
 Added the definition of Diagnostic Services
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02/21/2011
02/07/2011
Updated to further clarify guidelines to use for MRA and MRI when there are no
specific state LCDs for uses of MRA and MRI not specifically addressed by the NCDs
 Updated Section III (References)
 Deleted references that are no longer used in the CS
 Moved current references under Guidelines #1
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