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- Nov 12, 2013
- Messages
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- Reaction score
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FYI, limitations are being proposed for Epidural Injection as treatment option for chronic pain
This proposed LCD on Epidural Procedures for Pain Management services was announced on June 10, 2021. This nationwide policy contains many onerous changes that will detrimentally affect patient access to care. ASIPP is aware and already contacting congress members, but getting your patients to complain can also help.
Please see below for important points but one of the bigger points to note is that frequent epidural injections beyond 12 months period may trigger audit, unless you justify by doing additional documentation, including objective functional scores, and must last 3 months
(so 2.5 months of great pain relief will not be acceptable in view of Medicare - is my understanding)
"Covered Indications
Epidural steroid injection (ESI) will be considered medically reasonable and necessary when the following three
(3) requirements are met:
History, physical examination, and concordant radiological image-based diagnostic testing that supports
one of the following5:
Lumbar, cervical or thoracic radiculopathy and/or neurogenic claudication due to central disc herniation, osteophyte or osteophyte complexes, severe degenerative disc disease, producing foraminal or central spinal stenosis5 OR
* Post-laminectomy syndrome,6,7,8 OR Acute herpes zoster associated pain.6
•
1. AND
Radicular pain is severe enough to cause a significant degree of functional disability or vocational
disability measured at baseline using an objective pain scale*. A functional assessment scale must be
performed at baseline if function is considered as part of the assessment.
AND
Pain duration of at least four (4) weeks, and the inability to tolerate noninvasive conservative care or
medical documentation of failure to respond to four (4) weeks of noninvasive conservative care or acute
herpes zoster refractory to conservative management where a four (4) week wait is not required.9
2. The ESIs must be performed under CT or fluoroscopy image guidance with contrast.10
Transforaminal epidural steroid injections (TFESIs) involving a maximum of two (2) levels in one spinal region
are considered medically reasonable and necessary. It is important to recognize that most conditions would not
ordinarily require ESI at two (2) levels in one spinal region.
3.
Caudal epidural steroid injections (CESIs) and interlaminar epidural steroid injections (ILESIs) involving a
maximum of one level are considered medically reasonable and necessary.
4.
5. It is considered medically reasonable and necessary to perform TFESIs bilaterally only when clinically indicated.
Repeat ESI when the first injection directly and significantly provided improvement of the condition being
treated may be considered medically reasonable and necessary when the medical record documents at least
50% of sustained improvement in pain relief for at least three months and/or improvement in function
measured from baseline using SAME scale* for at least three months.7,8
6.
7. The ESI injectants must include corticosteroids, anesthetics, anti-inflammatories and/or contrast agents.1
8. The ESIs should be performed in conjunction with conservative treatments.9
9. Patients should be part of an active rehabilitation program, home exercise program or functional restoration program.10,11
*Note: The scales used to measure pain and/or disability must be documented in the medical record. Acceptable scales include, but are not limited to: Verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry
Low Back Pain Disability Questionnaire (OLBPDQ), Quebec Back Pain Disability Scale (QBPDS), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.
Limitations
Injections performed without image guidance or by ultrasound are not considered medically reasonable and
necessary.12,13,14
1. The ESIs performed with biologicals or other substances not FDA designated for this use are considered not medically reasonable and necessary.
2. It is not considered medically reasonable and necessary to perform multiple blocks (ESIs, sympathetic blocks, facet blocks, trigger point injections, etc.) during the same session as ESIs, with the exception of a facet synovial cyst and ESI performed in the same session.
3. Use of General Anesthesia, Moderate Sedation and Monitored Anesthesia Care (MAC) is usually unnecessary or rarely indicated for these procedures and therefore, is not considered medically reasonable and necessary.15 In exceptional cases documentation must clearly establish the need for such sedation in the specific patient.
4. The ESIs to treat non-specific low back pain (LBP), axial spine pain, complex regional pain syndrome, widespread diffuse pain, pain from neuropathy from other causes, or cervicogenic headaches are considered investigational and therefore are not considered medically reasonable and necessary.6,16,17
5. The ESIs are limited to a maximum of four (4) sessions per spinal region in a rolling twelve (12) month period.
7
6.It is not considered medically reasonable and necessary for more than one spinal region to be injected in the same session.
7. It is not considered medically reasonable and necessary to perform TFESIs at more than two (2) nerve root levels during the same session.
8. It is not considered medically reasonable and necessary to perform CESIs or ILESIs at more than one (1) level during the same session.
9.
10. It is not medically reasonable and necessary to perform CESIs or ILESIs bilaterally.13
11. It is not medically reasonable and necessary to perform ESIs in a series.8
Steroid dosing should be the lowest effective amount and not to exceed 40mg for methyl prednisone, 10-20mg for triamcinolone acetate, and 10mg (10mg/mL) for dexamethasone phosphate per session.15
12. It generally would not be considered medically reasonable and necessary for treatment with ESI to extend beyond 12 months.18,19 Frequent continuation of epidural steroid injections over 12 months may trigger a focused medical review. Use beyond twelve months requires the following:
13. Pain is severe enough to cause a significant degree of functional disability or vocational disability. The ESI provides at least 50% sustained improvement of pain and/or 50% objective improvement in function (using same scale as baseline).
Rationale for the continuation of ESIs including, but not limited to, patient is high-risk surgical candidate, the patient does not desire surgery, recurrence of pain in the same location relieved with ESIs for at least three months.
Communication with primary care provider regarding patients’ candidacy for prolonged repeat steroid use.
This proposed LCD on Epidural Procedures for Pain Management services was announced on June 10, 2021. This nationwide policy contains many onerous changes that will detrimentally affect patient access to care. ASIPP is aware and already contacting congress members, but getting your patients to complain can also help.
Please see below for important points but one of the bigger points to note is that frequent epidural injections beyond 12 months period may trigger audit, unless you justify by doing additional documentation, including objective functional scores, and must last 3 months
(so 2.5 months of great pain relief will not be acceptable in view of Medicare - is my understanding)
"Covered Indications
Epidural steroid injection (ESI) will be considered medically reasonable and necessary when the following three
(3) requirements are met:
History, physical examination, and concordant radiological image-based diagnostic testing that supports
one of the following5:
Lumbar, cervical or thoracic radiculopathy and/or neurogenic claudication due to central disc herniation, osteophyte or osteophyte complexes, severe degenerative disc disease, producing foraminal or central spinal stenosis5 OR
* Post-laminectomy syndrome,6,7,8 OR Acute herpes zoster associated pain.6
•
1. AND
Radicular pain is severe enough to cause a significant degree of functional disability or vocational
disability measured at baseline using an objective pain scale*. A functional assessment scale must be
performed at baseline if function is considered as part of the assessment.
AND
Pain duration of at least four (4) weeks, and the inability to tolerate noninvasive conservative care or
medical documentation of failure to respond to four (4) weeks of noninvasive conservative care or acute
herpes zoster refractory to conservative management where a four (4) week wait is not required.9
2. The ESIs must be performed under CT or fluoroscopy image guidance with contrast.10
Transforaminal epidural steroid injections (TFESIs) involving a maximum of two (2) levels in one spinal region
are considered medically reasonable and necessary. It is important to recognize that most conditions would not
ordinarily require ESI at two (2) levels in one spinal region.
3.
Caudal epidural steroid injections (CESIs) and interlaminar epidural steroid injections (ILESIs) involving a
maximum of one level are considered medically reasonable and necessary.
4.
5. It is considered medically reasonable and necessary to perform TFESIs bilaterally only when clinically indicated.
Repeat ESI when the first injection directly and significantly provided improvement of the condition being
treated may be considered medically reasonable and necessary when the medical record documents at least
50% of sustained improvement in pain relief for at least three months and/or improvement in function
measured from baseline using SAME scale* for at least three months.7,8
6.
7. The ESI injectants must include corticosteroids, anesthetics, anti-inflammatories and/or contrast agents.1
8. The ESIs should be performed in conjunction with conservative treatments.9
9. Patients should be part of an active rehabilitation program, home exercise program or functional restoration program.10,11
*Note: The scales used to measure pain and/or disability must be documented in the medical record. Acceptable scales include, but are not limited to: Verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry
Low Back Pain Disability Questionnaire (OLBPDQ), Quebec Back Pain Disability Scale (QBPDS), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.
Limitations
Injections performed without image guidance or by ultrasound are not considered medically reasonable and
necessary.12,13,14
1. The ESIs performed with biologicals or other substances not FDA designated for this use are considered not medically reasonable and necessary.
2. It is not considered medically reasonable and necessary to perform multiple blocks (ESIs, sympathetic blocks, facet blocks, trigger point injections, etc.) during the same session as ESIs, with the exception of a facet synovial cyst and ESI performed in the same session.
3. Use of General Anesthesia, Moderate Sedation and Monitored Anesthesia Care (MAC) is usually unnecessary or rarely indicated for these procedures and therefore, is not considered medically reasonable and necessary.15 In exceptional cases documentation must clearly establish the need for such sedation in the specific patient.
4. The ESIs to treat non-specific low back pain (LBP), axial spine pain, complex regional pain syndrome, widespread diffuse pain, pain from neuropathy from other causes, or cervicogenic headaches are considered investigational and therefore are not considered medically reasonable and necessary.6,16,17
5. The ESIs are limited to a maximum of four (4) sessions per spinal region in a rolling twelve (12) month period.
7
6.It is not considered medically reasonable and necessary for more than one spinal region to be injected in the same session.
7. It is not considered medically reasonable and necessary to perform TFESIs at more than two (2) nerve root levels during the same session.
8. It is not considered medically reasonable and necessary to perform CESIs or ILESIs at more than one (1) level during the same session.
9.
10. It is not medically reasonable and necessary to perform CESIs or ILESIs bilaterally.13
11. It is not medically reasonable and necessary to perform ESIs in a series.8
Steroid dosing should be the lowest effective amount and not to exceed 40mg for methyl prednisone, 10-20mg for triamcinolone acetate, and 10mg (10mg/mL) for dexamethasone phosphate per session.15
12. It generally would not be considered medically reasonable and necessary for treatment with ESI to extend beyond 12 months.18,19 Frequent continuation of epidural steroid injections over 12 months may trigger a focused medical review. Use beyond twelve months requires the following:
13. Pain is severe enough to cause a significant degree of functional disability or vocational disability. The ESI provides at least 50% sustained improvement of pain and/or 50% objective improvement in function (using same scale as baseline).
Rationale for the continuation of ESIs including, but not limited to, patient is high-risk surgical candidate, the patient does not desire surgery, recurrence of pain in the same location relieved with ESIs for at least three months.
Communication with primary care provider regarding patients’ candidacy for prolonged repeat steroid use.