American Society of Interventional Pain Physicians
" The Voice of Interventional Pain Management "
81 Lakeview Drive, Paducah, KY 42001
Tel.: (270) 554-9412; Fax : (270) 554-8987
E-mail:asipp@asipp.org
August 10, 2009
George Waldmann, M.D.
Bernice Hecker, MD, M.H.A., F.A.C.C.
William Mangold, M.D. JD
Noridian Administrative Services, LLC
900 42nd Street S
P.O. Box 6740
Fargo, ND 58108- 6740
Telephone: 503-944-8810
Fax: 503-944-8814
George.Waldmann@noridian.com
Bernice.Hecker@noridian.com
William.Mangold@noridian.com
RE:
Draft LCD for Non-Covered Services (DL24471) - Facet Joint Interventions
Part B:
Alaska, Oregon, Washington , Arizona, Montana, North Dakota, South Dakota, Utah
Wyoming
Dear Drs. Waldman, Hecker, and Mangold,
On behalf of the American Society of Interventional Pain Physicians (ASIPP), we are responding
to your potential determination of facet joint interventions as experimental. This will have a
major impact on patient access and care. Because we understand the tenuous nature of facet joint
interventions, waste, abuse, and fraud, we will briefly present the multiple aspects of facet joint
interventions evidence-based medicine, and why these procedures need to be covered. Further,
we will suggest appropriate measures to avoid waste, abuse, and fraud.
ASIPP is a not-for-profit professional organization comprised of nearly 4,000 interventional pain
physicians and other practitioners who are dedicated to ensuring safe, appropriate and equal
access to essential pain management services for patients across the country suffering with
chronic and acute pain. There are approximately 7,000 physicians practicing interventional pain
management in the United States.
INTERVENTIONAL PAIN MANAGEMENT
Interventional pain management is defined as the discipline of medicine devoted to the diagnosis
and treatment of pain related disorders principally with the application of interventional
techniques in managing sub acute, chronic, persistent, and intractable pain, independently or in
conjunction with other modalities of treatment.
Interventional pain management techniques are minimally invasive procedures, including
percutaneous precision needle placement, with placement of drugs in targeted areas or ablation of
targeted nerves; and some surgical techniques such as laser or endoscopic diskectomy, intrathecal
infusion pumps and spinal cord stimulators, for the diagnosis and management of chronic,
persistent or intractable pain
WASTE, ABUSE, AND FRAUD
OIG Study
The OIG report of 2008 (1) showed that Medicare paid over $2 billion in 2006 for interventional
pain management procedures. This report also showed that the Medicare payments for facet joint
injections increased from $141 million in 2003 to $307 million in 2006. Further, 63% of facet
joint injection services allowed by Medicare in 2006 did not meet Medicare program
requirements, resulting in approximately $96 million in improper payments. Further, Medicare
allowed an additional $33 million in improper payments for associated facility claims. This report
illustrated that facet joint injection services provided in an office were more likely to have an
error than those provided in an ambulatory surgery center or hospital outpatient department. The
OIG report also illustrated that 35% of Medicare facet joint injections were performed by noninterventional pain physicians; 19% by general practitioners, internists, and family practice
physicians; while the remaining 16% were performed by orthopedic surgeons, neurologists, and
rheumatologists. The OIG report recommended some radical changes in monitoring utilization of
interventional techniques. Subsequently, a memo has been issued.
While OIG is concerned about the issues, they have not recommended total elimination of the
procedures. Consequently, it is important to follow the recommendations rather than completely
remove facet joint interventions.
Manchikanti et al’s Studies
In a published report evaluating the analysis of the growth of interventional techniques in
managing chronic pain in the Medicare population from 1997 to 2006, Manchikanti et al (2)
showed that overall interventional techniques increased significantly in Medicare beneficiaries.
They also showed that the proportion of patients receiving interventional pain management
services per 100,000 Medicare population increased by 137%, the number of visits increased
144%, and services increased 197%. There was a disproportionate increase of 198% for patients
on Medicare under age 65 whereas, for those over 65, they increased 189%. Also shown was in
increase of 117% in Medicare patients for epidural procedures from 1997 to 2006, whereas for
facet joint interventions, the increases were 624%, along with a 596% increase for spinal cord
stimulation, with a total increase of 197%. While some of the increases are justifiable based on
increasing prevalence of chronic pain, diagnostic modalities, and increased access with
understanding, significant problems are realized with increases of several percentage points
beyond these explanations. Manchikanti et al (2) also noted a significant difference
geographically with Florida with a 11.6-fold difference (431% vs. 37% increase) between Florida
and California in 2006.
In another investigation by Manchikanti et al (3), which is currently pending publication,
shocking findings were identified. From 1997 to 2006, patients receiving facet joint interventions
increased 386%, visits increased 446%, whereas facet joint interventions increased 543% for
100,000 Medicare population (Table 1).
The differences were also significant in that patients under 65 years of age showed an increase of
504% per 100,000 Medicare population compared to 355% for those over 65 years. Similarly, the
2
increase for visits was 587% versus 404% and the increase for services was 683% versus 498%
(Table 1).
From 2002 to 2006 increases were seen with 271% in-office settings, 168% in ASC settings, and
40% in HOPD settings. Total payment increases showed 288% for in-office settings, 168% in
ASC settings, and 33% in HOPD settings, with an overall increase of 123% from 2002 to 2006.
Utilization of facet joint interventions by specialties has increased substantially. Overall, there
was 160% increase from 2002 to 2006. Of these, 122% was for interventional pain management
professionals (anesthesiology, pain management, neurology, neurosurgery, orthopedic surgery,
physical medicine and rehabilitation, and psychiatry). In contrast, the increases were 398% for
nurse practitioners and CRNAs, and 1,109% for general physicians (general practice, family
practice, and internal medicine), giving a 100% annual increase for nurse practitioners and
CRNAs and 277% annual increase for general physicians. The fluoroscopy utilization was also
based on the specialty with an increase seen in all specialties, but with lowest utilization of
fluoroscopy was by general physicians. Thus, fluoroscopy was utilized by 86% of the pain
physicians and only 19% of general physicians with an overall utilization of fluoroscopy in 63%
of the patients (Fig. 1).
3
Table 1. Characteristics of Medicare beneficiaries and facet joint interventions.
US Population (,000)
>= 65 years (,000)
Medicare Beneficiaries (,000)
Age
Gender
>= 65 years
< 65 years
Male
Female
Facet joint interventions
Number of Medicare patients receiving facet joint
interventions
Facet joint patients per 100,000
Number of visits
Facet joint visits Per 100,000
Services
Facet joint interventions per 100,000
Average visits per patient
Facet joint interventions by Age
Number of patients
< 65 years
Rate (per 100,000)
Patients
Number of patients
> 65 years
Rate (per 100,000)
Number of visits
< 65 years
Rate (per 100,000)
Visits
Number of visits
> 65 years
Rate (per 100,000)
Number of services
< 65 years
Rate (per 100,000)
Services
Number of services
> 65 years
% of increase
from
200219972006
2006
1997
267,784
34,933
38,465
33,636
4,829
40.70%
59.30%
2002
288,369
35,602
40,503
34,698
5,805
43.85%
56.15%
2006
299,395
37,125
43,339
36,317
7,022
44.16%
55.84%
3.8%
4.3%
7.0%
4.7%
21.0%
0.7%
-0.6%
11.8%
6.3%
12.7%
8.0%
45.4%
8.5%
-5.8%
46,640
121
88,280
230
233,200
606
1.9
119,160
294
225,280
556
607,760
1,501
1.9
254,720
588
543,900
1,255
1,688,180
3,895
2.1
114%
100%
141%
126%
178%
160%
NA
446%
386%
516%
446%
624%
543%
NA
9,800
25
36,840
96
19,840
52
68,440
178
56,040
146
177,160
461
27,060
67
92,100
227
54,960
136
170,320
421
148,720
367
459,040
1,131
65,420
151
189,300
437
154,760
357
389,140
898
495,480
1,143
1,192,700
2,752
142%
125%
106%
93%
182%
163%
128%
113%
233%
211%
160%
143%
568%
504%
414%
355%
680%
587%
469%
404%
784%
683%
573%
498%
4
2002
2006
100%
90%
86%
78%
80%
70%
68%
67%
60%
59%
60%
67%
63%
62%
48%
50%
42%
40%
40%
37%
34%
30%
29%
30%
23%
19%
19%
20%
17%
10%
0%
PM
A
PMR
DR
NS
OS
Ne
FGI
O
Total
PM-Pain Management; A-Anesthesiology; PMR-Physical Medicine and Rehabilitation; DR-Diagnostic
Radiology;
NS-Neurosurgery; OS-Orthopedic Surgery; NE-Neurology; FGI-Family & General Practice/Internal
Medicine; O-Others.
Fig. 1. Percentage of visits utilizing fluoroscopy based on specialty.
Procedural characteristics by state illustrated significant geographic variations and growth
patterns for 2006 (Table 2). Florida showed a 26.8-fold difference between the lowest state,
Hawaii. All other states showed less than a 10-fold difference, whereas the 9 states under
Noridian Administrative Services were below the national average, except Utah (Alaska), which
is just above the national average (Table 3).
5
Table 2. Number of facet joint services per 100,000 Medicare beneficiaries provided by state.
2002
2006
Services
534,000
3,514
96,460
6,386
115%
82%
9.87
2,680
142,960
5,445
128%
103%
8.42
8,240
1,692
23,040
4,752
180%
181%
7.34
800
714
5,520
4,187
590%
486%
6.47
400
874
2,000
4,026
400%
361%
6.22
Services
108,800
Rate per
100,000
population
3,603
Michigan
44,940
Texas
62,680
Arkansas
Delaware
Alaska
State
Florida
Mississippi
Kentucky
Utah
Tennessee
% of change from 2002
Rate
Rate per
100,000
Services
population
391%
381%
Rate
Rate per
100,000
population
17,340
Fold difference from the
lowest state for 2006
26.80
6,920
1,788
16,600
3,596
140%
101%
5.56
11,520
1,797
24,900
3,583
116%
99%
5.54
2,620
1,365
8,440
3,431
222%
151%
5.30
12,440
1,695
32,460
3,419
161%
102%
5.29
West Virginia
3,160
878
12,080
3,343
282%
281%
5.17
Montana
2,740
1,745
5,060
3,335
85%
91%
5.15
Maryland
8,500
1,302
23,320
3,294
174%
153%
5.09
North Carolina
15,840
1,331
42,400
3,218
168%
142%
4.97
Ohio
17,620
1,134
56,060
3,153
218%
178%
4.87
800
875
2,900
3,150
263%
260%
4.87
Vermont
South Carolina
6,540
965
21,160
3,140
224%
225%
4.85
Missouri
8,260
1,109
29,160
3,137
253%
183%
4.85
New Hampshire
3,320
2,024
6,200
3,134
87%
55%
4.84
Alabama
20,220
2,682
23,620
3,058
17%
14%
4.73
Indiana
12,620
1,485
28,140
3,050
123%
105%
4.71
Pennsylvania
31,560
1,552
63,740
2,957
102%
90%
4.57
Georgia
14,820
1,705
31,360
2,916
112%
71%
4.51
580
480
3,460
2,904
497%
504%
4.49
Iowa
7,780
1,784
13,960
2,823
79%
58%
4.36
Louisiana
4,220
701
17,500
2,804
315%
300%
4.33
Arizona
5,960
753
22,540
2,765
278%
267%
4.27
780
1,158
1,780
2,593
128%
124%
4.01
Massachusetts
10,280
1,155
25,240
2,571
146%
123%
3.97
California
55,060
1,458
103,000
2,409
87%
65%
3.72
Wisconsin
10,060
1,435
19,660
2,341
95%
63%
3.62
2,640
1,153
5,560
2,311
111%
100%
3.57
South Dakota
Wyoming
Maine
New York
27,660
1,057
63,840
2,276
131%
115%
3.52
New Mexico
2,720
925
6,120
2,219
125%
140%
3.43
Kansas
2,000
531
8,980
2,209
349%
316%
3.41
Illinois
17,060
1,054
37,180
2,171
118%
106%
3.35
Nevada
2,640
996
6,580
2,145
149%
115%
3.32
Virginia
10,720
1,203
19,900
1,955
86%
62%
3.02
New Jersey
13,320
1,073
23,180
1,867
74%
74%
2.89
Colorado
4,740
946
10,020
1,856
111%
96%
2.87
Oklahoma
5,920
1,159
10,260
1,854
73%
60%
2.86
Connecticut
3,040
559
9,160
1,728
201%
209%
2.67
Minnesota
3,440
587
11,940
1,674
247%
185%
2.59
Idaho
1,760
1,019
3,100
1,656
76%
63%
2.56
6
Nebraska
1,100
430
3,440
1,382
213%
222%
2.14
Washington
4,560
667
11,560
1,365
154%
105%
2.11
Rhode Island
880
511
2,060
1,332
134%
161%
2.06
1,440
295
7,240
1,310
403%
344%
2.02
North Dakota
960
930
1,160
1,184
21%
27%
1.83
District of Columbia
360
485
620
1,021
72%
110%
1.58
Oregon
Hawaii
720
420
1,100
647
53%
54%
1.00
Overall
607,760
1,501
1,688,180
3,895
178%
160%
6.02
The following table illustrates the changes in Noridian. Alaska, South Dakota, Arizona, Oregon,
increased above the national average of 160%, whereas Utah, Montana, Washington, North
Dakota, Hawaii and Idaho were below the average (Table 3).
Table 3. Number of facet joint services per 100,000 Medicare beneficiaries provided by Noridian
states.
2002
State
Florida
Alaska
2006
Services
108,800
Rate per
100,000
population
3,603
Services
534,000
Rate
Rate per
100,000
population
17,340
% of change from 2002
Rate
Rate per
100,000
Services
population
391%
381%
Fold difference from the
lowest state for 2006
26.80
400
874
2,000
4,026
400%
361%
6.22
Utah
2,620
1,365
8,440
3,431
222%
151%
5.30
Montana
2,740
1,745
5,060
3,335
85%
91%
5.15
580
480
3,460
2,904
497%
504%
4.49
Arizona
5,960
753
22,540
2,765
278%
267%
4.27
Washington
4,560
667
11,560
1,365
154%
105%
2.11
Oregon
1,440
295
7,240
1,310
403%
344%
2.02
960
930
1,160
1,184
21%
27%
1.83
South Dakota
North Dakota
Hawaii
720
420
1,100
647
53%
54%
1.00
Overall
607,760
1,501
1,688,180
3,895
178%
160%
6.02
7
In summary, there is no doubt there is waste, abuse, and fraud in performing facet joint
interventions. Even the diagnostic information and documentation is extremely poor, except for
the physicians who are designated as IPM (Table 4).
Table 4. Physician specialty error rate in an office setting.
Source: Office of Inspector General analysis of medical review results, 2008.
* Figures are based only on the sample and are not projected to the population.
Causes of Increase
Increases may be justified to a certain extent with an 11.6% increase in chronic pain population
(4) and increasing enrollment of patients under the age of 65 who seem to receive a higher
proportion of facet joint interventions. However, major increases continue.
Deleterious Effects
Deleterious effects of elimination of facet joints include an exponential overall increase of
unrelated and less effective modalities for facet joints with increase of epidural injections, as well
as peripheral nerve blocks, trigger point injections, etc. This will increase waste, abuse, and fraud,
and will not reduce the costs. Finally, it will hamper patient access and also increase cost to the
program.
Solutions
Consequently, strict regulations must be implemented. Health care experts have recommended
that we need policies that encourage high-growth or high-cost regions to behave more like lowgrowth, low-cost regions and to encourage low-cost, slow-growth regions to sustain their current
8
needs for interventional techniques in order to slow the spending growth. OIG has recommended
strengthening program efforts to prevent proper payments. Manchikanti et al (2) have also
recommended tighter regulations on medical necessity and indications and settings in which
procedures are performed.
EVIDENCE-BASED MEDICINE
Facet joints are one of the common structures responsible for spinal pain, in addition to
intervertebral discs, sacroiliac joint, nerve root dura, etc (5-11). Facet joints are well innervated
and also have been shown to be a source of pain in the neck and referred pain in the head and
upper extremities; upper back, mid back, referred pain in the chest wall, as well as the low back
and referred pain in the lower extremity (9-11). Recent evaluations utilized strict criteria of 80%
pain relief and ability to perform painful movements with controlled diagnostic blocks. Datta et al
(11) showed the diagnostic accuracy of lumbar facet joint interventions, with a prevalence of 21%
to 40% in heterogenous population with chronic low back pain and 16% in post lumbar surgery
syndrome with an overall prevalence of 31% and overall false-positive rates of 30% (Table 5).
Similarly, Falco et al (10) showed an average prevalence of 49% utilizing 9 studies with an
average false-positive rate of 49% (Table 6). Atluri et al (9) showed an average prevalence of
40% utilizing 3 studies with an average false-positive rate of 42% (Table 7).
Table 5. Data of prevalence with controlled diagnostic blocks and false-positive rates in the
lumbar region.
Study
Methodological
Criteria *
Participants
Prevalence
False-Positive Rate
Manchikanti et al 2002 (16)
75
120
40% (95% CI 31%–49%)
30% (95% CI 20%–40%)
Manchikanti et al 2004 (17)
Manchukonda et al 2007
(18)
Schwarzer et al 1995 # (22)
75
397
31% (95% CI 27%–36%)
27% (95% CI 22%–32%)
75
303
27% (95% CI 22%–33%)
45% (95% CI 36%–53%)
75
63
40% (95% CI 29%–53%)
NA
Manchikanti et al 2001 (23)
75
120
40% (95% CI 31%–49%)
I. 21% (95% CI 14%–
27%) II. 41% (95% CI
33%–49%)
16% (95% CI 9%–23%)
47% (95% CI 35%–59%)
I. 17% (95% CI 10%–
Manchikanti et al 2003 (24)
75
300
24%) II. 27% (95% CI
18%–36%)
Manchikanti et al 2007 (25)
75
117
49% (95% CI 39%–59%)
30%# (95% CI; 27%–
Overall
1,420
31% (95% CI; 28%–33%)
33%)
CI = confidence interval; NA =not available; # Schwarzer et al (22) was without evaluation of false-positive rates.
*Methodologic quality assessment adapted and modified from West S et al. Systems to Rate the Strength of Scientific
Evidence, Evidence Report, Technology Assessment No. 47. AHRQ Publication No. 02-E016.
Source: Datta S et al. Systematic assessment of diagnostic accuracy and therapeutic utility of lumbar facet joint
interventions. Pain Physician 2009; 12:437-460 (11).
9
Table 6. Data of prevalence and false-positive rates of cervical diagnostic facet joint blocks.
Methodologic
Criteria
# of Subjects
Prevalence Estimates
False-Positive Rate
Barnsley et al 1995 (13)
75
50
54% (95% CI, 40%, 68%).
NA
Barnsley et al 1993 (14)
75
55
NA
27% (95% CI, 15%, 38%)
Lord et al 1996 (15)
Manchikanti et al 2002
(16)
Manchikanti et al 2004
(17)
75
68
60% (95% CI, 46%, 73%)
NA
75
120
67% (95% CI, 58%,75%)
63% (95% CI 48%, 78%)
75
255 of 500
55% (95% CI, 49%, 61%)
63% (95% CI 54%, 72%)
65
251 of 500
39% (95% CI, 32%, 45%)
45% (95% CI 37%, 52%)
Non-Surgery:
206
Non-Surgery 39% (95% CI,
33%, 46%)
Non-Surgery 43% (95% CI
35%, 52%)
Post-Surgery:
45
Post-Surgery 36% (95% CI,
22%, 51%)
Post-Surgery 50% (95% CI
32%, 68%)
Study
Manchukonda et al 2007
(18)
Manchikanti et al 2008
(19)
65
Speldewinde et al 2001
50
97
36% (95% CI, 27%, 45%)
NA
(20)
Yin and Bogduk 2008
60
84 of 143
42%# (95% CI, 31%, 52%)
NA
(21)
OVERALL
980
49% (95% CI, 45%, 52%)
49% (95% CI, 44%, 54%)
# Authors reported adjusted prevalence as 55% (95% CI, 38%, 62%) and crude prevalence as 24%.
NA = not available or not applicable; CI = confidence interval
Source: Falco FJE et al. Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint
interventions. Pain Physician 2009; 12:323-344 (10).
Diagnosis
The diagnostic techniques and diagnosis is proven in multiple studies and systematic reviews (911). In fact, Rubinstein and van Tulder (12) showed moderate evidence for accuracy of diagnosis
of facet joint pain utilizing diagnostic facet joint nerve blocks.
Table 7. Data of prevalence with controlled diagnostic blocks and false-positive rates in thoracic
region.
Methodological
Quality Scoring
(AHRQ)
Participants
Manchikanti et al 2002 (26)
70
46
Manchikanti et al 2004 (17)
70
72
Manchukonda et al 2007 (18)
60
65
Study
Prevalence
48% (95% CI 34%–
62%)
42% (95% CI 30%–
53%)
34% (95% CI 22%–
47%)
COMBINED RESULTS
173
40% (95% CI 33%-48%)
(AVERAGE)
AHRQ=Agency for Healthcare Research and Quality; CI = confidence interval
False-Positive Rate
58% (95% CI 38%–
78%)
55% (95% CI 39%–
78%)
42% (95% CI 26%–
59%)
42% (95% CI 33%–
51%)
Source: Atluri S et al. Systematic review of diagnostic utility and therapeutic effectiveness of thoracic facet joint
interventions. Pain Physician 2008; 11:611-629 (9).
10
However, to avoid false-positives and unnecessary treatment, the diagnosis must be made only by
controlled diagnostic blocks with 80% relief and ability to perform previously painful maneuvers.
Otherwise the prevalence may be increased to 60% to 70%, which has probably led to explosive
growth of facet joint interventions without providing appropriate care.
Treatment of Facet Joint Pain
Once an appropriate diagnosis is performed, facet joint pain may be managed by intraarticular
injections, medial branch blocks, or neurolysis of medial branches (9-11).
Recent systematic reviews (9-11) have shown no evidence for therapeutic effectiveness of
intraarticular facet joint injections; thus, these have not been recommended (8-11). In contrast,
medial branch blocks have been recently well studied with emerging evidence (Table 8). Three
systematic reviews have included 4 randomized trials and 2 observational studies (9-11) showing
Level II-1 to II-2 evidence with a strong recommendation of 1B or 1C for therapeutic medial
branch blocks.
Table 8. Results of published reports of effectiveness of cervical, thoracic, and lumbar medial
branch blocks.
Long-term
Relief
Study
Study
Characteristics
Methodological
Quality
Score(s)
No. of Patients
3 mos.
6
mos.
12
mos.
Results
Shortterm
relief
≤6
mos.
Longterm
relief
>6
mos.
CERVICAL
Manchikanti et al
2008 (35)
RA, DB
76
76
83%
vs
85%
87%
vs
95%
85%
vs
92%
P
P
Manchikanti et al
2004 (36)
O
69
100
92%
82%
56%
P
P
Manchikanti et al
2008 (37)
RA, DB
60
Group I - no
steroid=24 Group
II - steroid=24
79%
vs
83%
79%
vs
81%
79%
vs
79%
P
P
Manchikanti et al
2006 (38)
O
69
55
71%
71%
76%
P
P
RA, DB
73
Group I - no
steroid = 60 Group
II - steroid = 60
83%
vs
82%
83%
vs
93%
82%
vs
85%
P
P
P
P
THORACIC
LUMBAR
Manchikanti et al
2008 (39)
Manchikanti et al
RA
59
73
100%
82%
21%
2001 (40)
RA = randomized; DB = Double-blind; O = observational; vs = versus; P = positive; N = negative
Source:
Falco FJE et al. Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint
interventions. Pain Physician 2009;
12:323-344 (10).
Atluri S et al. Systematic review of diagnostic utility and therapeutic effectiveness of thoracic facet joint interventions.
Pain Physician 2008;
11:611-629 (9).
11
Datta S et al. Systematic assessment of diagnostic accuracy and therapeutic utility of lumbar facet joint interventions.
Pain Physician 2009;
12:437-460 (11).
Recent systematic reviews (10,11) also have shown Level II-1 to II-2 evidence for cervical
medial branch radiofrequency neurotomy and Level II-2 to II-3 for lumbar radiofrequency
neurotomy (Table 9).
Table 9. Published results of studies of cervical and lumbar facet joint nerve neurotomy.
Pain Relief (months)
Study
Study
Characteristics
Methodological
Quality
Score(s)
Number
of
Patients
6 mos.
12 mos.
Results
≤ 6 mos.
Longterm
relief
> 6 mos.
P
P
P
P
Shortterm relief
Cervical
58% in active
treatment
group
Mean VAS
change 4.6 ±
1.8
RA, DB
67
24-control
24-active
1 of
sham 7
of active
O
87
46
NA
O
65
28
NA
71%
P
P
O
54
35
NA
74%
P
P
RA, DB
50
20-control
20-active
SI
NA
P
NA
Gofeld et al
2007 (32)
O
63
174
68%
NA
P
P
Dreyfuss et al
2000 (33)
O
73
15
87%
87%
P
P
Lord et al
1996 (27)
Sapir and
Gorup 2001
(28)
McDonald et
al 1999 (29)
Barnsley 2005
(30)
Lumbar
Nath et al
2008 (31)
RA = randomized; DB = double blind; O = Observational; NA = not available; SI = significant
improvement; VAS = visual analog scale; P = positive; N = negative
Source:
Falco FJE et al. Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint
interventions. Pain Physician 2009; 12:323-344 (10).
Datta S et al. Systematic assessment of diagnostic accuracy and therapeutic utility of lumbar facet joint
interventions. Pain Physician 2009; 12:437-460 (11).
12
Thus, there is significant evidence for these procedures with valid diagnosis and appropriate
outcomes reducing waste, abuse, and fraud. Waste, abuse, and fraud can be substantially reduced
or even eliminated while still maintaining access to the patients and also providing appropriate
care which is the mission of Medicare.
Indications
Based on available evidence and existing Local Coverage Determinations, we recommend the
following indications be documented and followed appropriately.








Patients suffering with somatic or non-radicular low back and lower extremity pain and
neck pain or headache and upper extremity pain, with duration of pain of at least 3
months.
Average pain levels are of greater than 6 on a scale of 0 to 10.
Pain is at least intermittent or continuous causing functional disability.
Condition has failed to respond to more conservative management, including physical
therapy modalities with exercises, chiropractic management, and non-steroidal antiinflammatory agents.
Lack of preponderance of evidence of either discogenic or sacroiliac joint pain and lack
of disc herniation or evidence of radiculitis.
No evidence of contraindications is present for the needle placement and injection of
local anesthetics.
Presence of contraindications or inability to undergo physical therapy, chiropractic
management, or inability to tolerate non-steroidal anti-inflammatory drugs.
A positive response is based on the following evidence:

Patient has met the above indications.

Patient responds positively to controlled local anesthetic blocks either with
placebo control or comparative local anesthetic blocks with appropriate response
to each local anesthetic (< 1 mL per level).

At least 80% relief as criterion standard with ability to perform previously
painful movement without deterioration of the relief (i.e., extension, lateral
rotation, flexion, etc.).

The patient’s response should be recorded independently by the assessor generally a registered nurse familiar with patient or another physician.
Therapeutic

Indications are the same as described for diagnostic facet joint nerve blocks. For
therapeutic interventions, the diagnosis must be established with a positive response to
controlled local anesthetic blocks with 80% relief.
Frequency

In the diagnostic phase, a patient may receive 2 procedures at intervals of no sooner than
one week or preferably 2 weeks, with careful judgment of response.

In the therapeutic phase (after the diagnostic phase is completed), the suggested
frequency would be 2-3 months or longer between injections, provided that ≥ 50% relief
is obtained for 8 weeks.

If the interventional procedures are applied for different regions, they may be performed
at intervals of no sooner than one week or preferably 2 weeks for most types of
procedures.
13




It is suggested that therapeutic frequency remain at least a minimum of 2 months
for each region; it is further suggested that all the regions be treated at the same
time provided that all procedures can be performed safely.
In the treatment or therapeutic phase, facet joint interventions should be repeated only as
necessary according to the medical necessity criteria, and it is suggested that these be
limited to of 4 times for local anesthetic and steroid blocks over a period of one year, per
region.
For medial branch neurotomy, the suggested frequency would be 6 months or longer
between each procedure, provided that 50% or greater relief is obtained for 10 to 12
weeks, per region.
Cervical and thoracic are considered as one region and lumbar and sacral are considered
as one region for billing purposes.
Present LCDs
To combat the problem of overuse, and to some extent abuse, the OIG has recommended
strengthening program safeguards to prevent improper payment for IPM services. Consequently,
to do so, CMS should establish LCDs across the country. These should be based on reasonable
LCDs which have been shown certain IPM procedures to be effective without compromising
patient access and care and which assist carriers in developing ways to scrutinize claims for IPM
services in all settings with a special focus on in-office settings.
Proper guidelines with appropriate LCDs in Kentucky and Indiana have demonstrated a low
growth rate and also a low abuse rate. Finally, geographic variations and increases cannot always
be attributed to waste, abuse, and fraud; they may also be related to increased levels of access and
also understanding of the pain problems appropriately and increased knowledge and awareness of
multiple interventions available (34). NGS federal policies utilized in multiple states have been
developed comprehensively with 2 revisions. These may be adopted.
We recommend a comprehensive policy of all interventional techniques as of NGS.
SUMMARY
In summary, we would like to request that you reconsider this policy to prevent waste, abuse, and
fraud and at the same time, maintain appropriate access. Properly implemented LCDs will assist
in achieving these goals. Further, the Medicare Carrier Directors and CMS have also requested
Congress to set regulations limiting these procedures to be performed by well-trained, wellqualified physicians in accredited settings under fluoroscopy only with the appropriate indications
and medical necessity.
Thank you. If you have any further questions, please feel free to contact us.
Laxmaiah Manchikanti, MD
Chief Executive Officer and Chairman of the Board, ASIPP and SIPMS
Medical Director, Pain Management Center of Paducah
2831 Lone Oak Road
Paducah, KY 42003
Phone: 270-554-8373 ext. 101
Fax: 270-554-8987
14
E-mail: drm@asipp.org
LM/tmh
cc:
Marsha Mason Wonsley, CMS CPT Coding Specialist
15
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2.
3.
4.
5.
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7.
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9.
10.
11.
12.
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18
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19