References relevant to the LCD Comments being submitted:
Rawool, N and Nazarian, L; Seminars in Ultrasound CT and MRI, Vol 21, No 3 (June),
2000: pp 275-284; "to evaluate tendons (tears,tendinitis,tenosynovitis), joints, plantar
fascia, ligaments, ganglion cysts, Morton's neuroma and to look for foreign bodies
link:
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKE
wj44tDSzMrJAhXHJB4KHW6cCEwQFggdMAA&url=http%3A%2F%2Fpdf.posterng.n
etkey.at%2Fdownload%2Findex.php%3Fmodule%3Dget_pdf_by_id%26poster_id%3D1
26460&usg=AFQjCNH0XAuzlrmDWGpmhSh2jZiwPfUAfQ&sig2=x_qsccPmPqHD_q
MYdfbCeA
Ultrasound-Often the initial imaging modality of choice. Referencehttp://radiopaedia.org/articles/plantar-fasciitis
Application of Ultrasound in the Assessment of Plantar Fascia in Patients With Plantar
Fasciitis: A Systematic Review
Ultrasound in Medicine & Biology Volume 40, Issue 8, August 2014, Pages 1737–1754
link at pubmed: http://www.ncbi.nlm.nih.gov/pubmed/24798393
Diagnostic Accuracy of Clinical Tests for Morton's Neuroma Compared With
Ultrasonography Original Research Article
The Journal of Foot and Ankle Surgery, Volume 54, Issue 4, July–August 2015, Pages
549-553
Devendra Mahadevan, Muralidharan Venkatesan, Raj Bhatt, Maneesh Bhatia
link at JFAS: http://www.jfas.org/article/S1067-2516(14)00450-5/abstract
Morton's neuroma: A clinical versus radiological diagnosis Original Research Article
Foot and Ankle Surgery, Volume 18, Issue 1, March 2012, Pages 22-24
Philip Pastides, Sameh El-Sallakh, Charalambos Charalambides
link: http://www.sciencedirect.com/science/article/pii/S1268773111000245
Ultrasound scan for the diagnosis of interdigital neuroma
Foot and Ankle Surgery, Volume 11, Issue 3, 2005, Pages 175-177
D. Gomez, K. Jha, K. Jepson
link: http://www.sciencedirect.com/science/article/pii/S1268773105000275
The accuracy of ultrasonography and magnetic resonance imaging for the diagnosis of
Morton's neuroma: a systematic review Review Article
Clinical Radiology, Volume 70, Issue 4, April 2015, Pages 351-358
Z. Xu, X. Duan, X. Yu, H. Wang, X. Dong, Z. Xiang
link: http://www.sciencedirect.com/science/article/pii/S0009926014004942
McMillan et al., 2009 A.M. McMillan, K.B. Landorf, J.T. Barrett, H.B. Menz, A.R. Bird
Diagnostic imaging for chronic plantar heel pain: A systematic review and meta-analysis
J Foot Ankle Res, 2 (2009), p. 32
link: http://www.biomedcentral.com/content/pdf/1757-1146-2-32.pdf
Abdel-Wahab et al., 2008 N. Abdel-Wahab, S. Fathi, S. Al-Emadi, S. Mahdi
High-resolution ultrasonographic diagnosis of plantar fasciitis: A correlation of
ultrasound and magnetic resonance imaging
Int J Rheum Dis, 11 (2008), pp. 279–286
link: http://onlinelibrary.wiley.com/doi/10.1111/j.1756185X.2008.00363.x/abstract;jsessionid=56B363D2792445B2331945AB8AAC9F2D.f01t
03?userIsAuthenticated=false&deniedAccessCustomisedMessage=
Cheng et al., 2012 J.W. Cheng, W.C. Tsai, T.Y. Yu, K.Y. Huang Reproducibility of
sonographic measurement of thickness and echogenicity of the plantar fascia
J Clin Ultrasound, 40 (2012), pp. 14–19
link: http://onlinelibrary.wiley.com/doi/10.1002/jcu.20903/abstract?userIsAuthenticated
=false&deniedAccessCustomisedMessage=
Kane et al., 2001 D.J. Kane, T.V. Greaney, M. Shanahan, G.J. Duffy, B. Bresnihan, R.G.
Gibney, O.M. FitzGerald
The role of ultrasonography in the diagnosis and management of idiopathic plantar
fasciitis
Rheumatology (Oxford), 40 (2001), pp. 1002–1008
link: http://www.sciencedirect.com/science/article/pii/S0301562914001483
Karabay et al., 2007 N. Karabay, T. Toros, C. Hurel Ultrasonographic evaluation in
plantar fasciitis
J Foot Ankle Surg, 46 (2007), pp. 442–446
link: http://www.sciencedirect.com/science/article/pii/S1067251607002918
Mahowald et al., 2011 S. Mahowald, B.S. Legge, J.F. Grady The correlation between
plantar fascia thickness and symptoms of plantar fasciitis
J Am Podiatr Med Assoc, 101 (2011), pp. 385–389
link: http://www.japmaonline.org/doi/abs/10.7547/1010385
Thomas et al., 2010 J.L. Thomas, J.C. Christensen, S.R. Kravitz, R.W. Mendicino, J.M.
Schuberth, J.V. Vanore, L.S. Weil Sr, H.J. Zlotoff, R. Bouché, J. Baker
The diagnosis and treatment of heel pain: A clinical practice guideline—Revision 2010
J Foot Ankle Surg, 49 (2010), pp. S1–S19
link: http://www.sciencedirect.com/science/article/pii/S1067251610000025
Tsai et al., 2000a W. Tsai, M.F. Chiu, C. Wang, F. Tang, M. Wong
Ultrasound evaluation of plantar fasciitis
Scand J Rheumatol, 29 (2000), pp. 255–259
link: http://europepmc.org/abstract/med/11028848
LCD with Issues highlighted and necessary changes:
Proposed LCD ID DL35409
Note: The two CPT codes addressed in this LCD (76881 and 76882) are for diagnostic
purposes only and not to be used or billed for therapeutic purposes.
Non-Vascular extremity ultrasound examination (complete and limited) may be
medically reasonable and necessary for the following conditions:
1.To detect cysts, abscesses and effusions;
2.To distinguish solid tumors from fluid-filled cysts;
3.To evaluate tendons (including tears, especially those that are partial, tendonitis and
tenosynovitis), joints, ligaments, soft tissue masses, nerve compression and stress
fractures;
4.To aid in the diagnosis of and surgical removal of foreign bodies.
5.To evaluate plantar fasciitis unrelated to spondyloarthropathy when all of the following
are met:
a.When only used once; AND
b.Only after a failed course of at least 6 months of conservative treatment; AND
c.Only when the medical records indicate that another disease process or pathology is
indicated.
Please see the documentation requirements of this LCD below for information regarding
proper documentation required to submit CPT 76881 and 76882. This documentation
must be maintained in the medical record and presented to the contractor upon request.
Limitations:
1.Extremity ultrasound must be performed by individuals who possess the knowledge and
skill required for the proper performance of this test. This includes, but is not limited to,
physicians, Nurse Practitioners (NPs), Physician Assistants (PAs) or qualified technicians
(sonographers). Sonographers, NPs or PAs must be under the general supervision of a
physician. Documentation of training or qualifications must be kept on file and be made
available to the contractor upon request.
2.Extremity ultrasound (CPT codes 76881 and 76882) is limited to studies of the arms
and legs. The upper extremity includes any part of the arm from the shoulder joint
through the fingers including the clavicular and the scapular portions of the upper
appendage but excluding the sternoclavicular joint. The lower extremity includes any part
of the leg inferior to or below the inguinal ligament.
3.Extremity ultrasound including but not limited to the following conditions is considered
not medically reasonable and necessary and therefore non-covered:◦Avascular necrosis
◦Bunions
◦Chondromalacia patella
◦Cruciate ligament disorder
◦Hoffa’s fat pad
◦Intra articular loose bodies
◦Labrum disorders of the hip or shoulder
◦Marrow disorders
◦Meniscal disorders
◦Neuromas CAC Response: needs to be removed from list see reason below
◦Os trigonum syndrome
◦Osteochondritis dissecans or osteochondral defect
◦Osteomyelitis
◦Paronychia
◦Peripheral nerve injections CAC Response: this is not a diagnosis or condition needs to
be removed The peripheral nerve injections would not be done with this set of coding.
◦Plantar plate injuries CAC Response: needs to be removed from list see reason below
◦Plantar warts
◦Sesamoid complex disorders CAC Response: needs to be removed from list see reason
below
◦Shoulder dislocation
◦Spurs (including shoulder spurs)
◦Superficial abscesses
◦Superficial ganglia
◦Tumors CAC Response: needs to be removed from list see reason below
4.Bilateral studies are allowed only if there is pathology of both extremities dictating
medical necessity for two distinct examinations. It is not reasonable and necessary to
perform the contralateral extremity as a "control" or for comparison with normal.
5.In the case of plantar fasciitis unrelated to spondyloarthropathy, diagnostic ultrasound
is NOT to be used in making an initial determination (diagnosis).
b. Only after a failed course of at least 6 months of conservative treatment; AND
CAC Response: Clearly the literature supports limited diagnostic ultrasound for plantar
fasciitis. This policy allows for every sprain and strain but plantar fasciitis alone, this is
discriminatory. Adding the term “ unrelated to spondyloarthropathy ( meaning
ankylosing spondylitis, Reiter's syndrome, reactive arthritis or psoriatic arthritis) is not
typical.and is very rare and not necessary to be part of this LCD. Next issue to address, 6
months to diagnose using an ultrasound is not an acceptable standard of care, there is no
literature to back up this policy statement. Clearly Novitas has made a point to follow
the literature, the CAC respectfully request this statement should be removed. If there is
a need to limit the utilization, then the CAC suggests decreasing the period of time (say a
month) or adding a statement that says it should be performed only if the clinical findings
are not obvious as to the etiology. Pages 27 through 30 of the draft LCD, have 74 ICD-10
Codes that support the medical necessity of diagnostic ultrasound for a sprain, strain, or
"other injury" of EVERY SINGLE muscle, fascia, and tendon of the wrist, hand, and
finger. All of these codes are for the initial encounter. If you include the sequela, you
have 148 ICD-10 codes. MSK example, if someone goes into a clinician's office after
hyperextending their hand from playing volleyball, the clinician can use the diagnostic
ultrasound (and be covered) to diagnose a sprain or strain at the very first visit. He/she
can use the ultrasound even if the clinical picture is obvious that there is no serious injury
and that it is just a sprain or strain.
The CAC recommends that point #5 should be deleted in its entirety and add plantar
fasciitis to the list of covered diagnoses without time limitations.
6.More than one complete ultrasound per joint, per extremity, in a 12 month period will
be considered not medically necessary.
7.More than four extremity ultrasounds total in a 12 month period, complete or limited,
will be considered not medically necessary.
CAC Response: While it is expected that the same anatomical site would not need a
complete or limited ultrasound, certainly it is possible that another anatomical site could
develop a problem unrelated to the original problem. Ultrasound which is medically
necessary should always be covered and now would not be covered based on this
limitation #7.
The CAC recommends that point #7 should be restated as: More than four extremity
ultrasounds total in a 12 month period, complete or limited, will be considered not
medically necessary if repeating at the same anatomical location. More than 4 will
require medical review.
The following support the medical necessity of procedure codes 76881 and 76882:
Group 1 Codes: (1154 entries in Group 1)
#2 Indication above states" To distinguish solid tumors from fluid-filled cysts; "
CAC Response: Novitas has listed as the last not covered item "Tumors". Tumors should
be removed from the non-covered conditions because in #2 of the indications it states that
you CAN use the ultrasound to distinguish solid tumors from fluid-filled cysts.
Based on this draft LCD, if you say that tumors are a non-covered condition, and a
clinician uses it to distinguish between a solid tumor or a fluid-filled cyst, it would be a
covered service if it turns out to be a cyst, but it would not be covered if it turns out to be
a tumor. Not covering tumors does not correspond with this LCD's accepted indications.
Neuromas - CAC Response: Novitas has listed every lesion of nerve but intermetatarsalneuroma this is another discriminatory policy while all others are allowed in the
extremities. Neuromas are compressed nerves which are covered under #3 of the
indications. When the condition fails to show signs of the obvious clinical symptoms, the
ultrasound can be helpful in ruling out a stress fracture of the lesser metatarsals, a
lumbrical muscle tear, or a joint capsule tear (all of which are covered under #3 of
indications as well).
Plantar plate injuries - CAC Response: A plantar plate injury is a tear to the plantar joint
capsule. Initially, it cannot be differentiated from a lesser metatarsal stress
fracture. Either way, both are covered under #3 of the indications (Evaluation of joints
and stress fractures). Plantar plate injuries and stress fractures may present the same
initially, but treatment will be different based on the findings. Ultrasound should be
available to evaluate this lower extremity joint, just like it is available to treat any other
extremity joint.
Sesamoid complex disorders - CAC Response: The sesamoid complex is made up of:
• 1 intersesamoid ligament - connects the two hallux sesamoids strongly to form one
functional unit
•2 collateral ligaments - medial and lateral
•1 abductor hallucis tendon - medial aspect of hallux sesamoid complex
•1 adductor hallucis tendon - lateral aspect of hallux sesamoid complex
•1 flexor hallucis longus tendon
•1 flexor hallucis brevis tendon
•2 sesamoid bones
Indication #3 allows us to use the ultrasound to evaluate tendons (4 in this complex),
joints (1 in this complex or 3 if you include the articulation with the sesamoids to the first
metatarsal head), ligaments (3 in this complex), and stress fractures (2 bones in this
complex)....all of which can be a part of the sesamoid complex injury. For this reason,
there is no reason why this should be excluded from the indications.
Summary: Not allowing the use of ultrasound as a diagnostic tool to help make a proper
diagnosis in these proposed non-covered conditions is like being handed a box and being
asked to tell what is in it. The way that this draft reads, it is discriminatory to a number
of lower extremity conditions. We would like to ask for a level playing field for lower
extremity injuries by changing the draft LCD to address the above concerns.
The standard of care is to use diagnostic ultrasound or MRI to evaluate soft tissue
pathology that a health care provider can't diagnose by examination alone. We don't think
that there is any need to take a less expensive diagnostic tool similar in reimbursement as
x-ray out of the hands of the clinician who is properly trained in musculoskeletal
diagnostic Ultrasound.
US aids in early diagnosis, US provides early intervention, and US provides an ability to
heal their effected part quicker reducing the number of visits and additional care that
would be needed for waiting 6 months to make the ultimate diagnosis in the case of
plantar fasciitis. This notion of waiting is not the standard of care nor is it appropriate
medicine in 2016.