SCS & PNS LCD Proposal by CMS - all neurostimulator practitioners should be acting on this now

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-Sojourner-

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Hey everyone,

The time has finally come for the CMS to screw with SCS and PNS LCD

PNS Is being affected, and also the proposal limits SCS/PNS to just ONE TIME per lifetime of the patient.
(1) patient with CRPS of the legs, gets SCS for that, and later it spreads the arms, they are screwed.
(2) Patient with SCS for lumbar postlaminectomy who later gets cervical ACDF but has chronic radic pain in the arm is also SOL.
(3) same goes for shoulder replacement and knee replacement patient with pain in both the shoulder and the knee, etc.

Period for receiving comments is currently open. I recommend anyone who does SCS/PNS should spend the time to send in your comments, and also to send it to your respective legislators.

I've included sample letter below (from my NALU rep), as well as the CMS proposal.

Sample Submission:

Date

Physician Name
Practice
Address
City, State Zip

Via Electronic Submission to [email protected]

RE: Public Comment for Proposed LCD - Nerve Stimulators for Chronic Intractable Pain (DL39406)

First Coast Service Options (FSCO) Medical Directors and Medical Affairs Teams,

I am a (enter specialty/credentials here), and I have been treating patients with chronic intractable pain for X years. (Add additional personal practice content here, such as – do you have a large Medicare population?). After reviewing the FCSO Proposed LCD, Nerve Stimulators for Chronic Intractable Pain, I felt it imperative that I comment on behalf of my patients.

Neurostimulators have proven efficacy for numerous neuropathic conditions and intractable pain conditions. I foresee that the following clause is going to have unnecessary detrimental effects in our ability to provide effective and high quality care of pain management in a large patient population.

I am very concerned about the following LCD proposal of limitation: “The implantation of more than one spinal cord stimulator or peripheral nerve stimulator device in the same patient at the same time.18 SCS and PNS device implantation is limited to once per lifetime per patient, unless the device must be revised or replaced (e.g., due to device malfunction).”

Many chronic pain patients suffer from more than one area of the body with severe intractable pain. Neurostimulator can be used to effectively manage pain in one region, but one neurostimulator does not cover the ‘entire body’. As an example, a patient with history of cervical fusion surgery and leg amputation may suffer from severe pain in the neck as well as phantom limb pain in the leg. Placement of neurostimulator in the cervical spine can help the neck pain but it will not help phantom limb pain in the leg in this instance – in this case a second neurostimulator is required to help the leg pain, but according to the proposed LCD changes limiting to just one neurostimulator per patient in lifetime, the patient will still suffer from intractable phantom limb pain. In this case the patient will be left with no choice but to resort to addictive opioid pain medications which ought not to be the case as the nation is already suffering from problems of opioid addiction.

In the eyes of pain medicine practitioners, the above proposed LCD is akin to stating that a patient with severe osteoarthritis of both knees can only have one knee replaced but not the other. This proposal just does not make any sense.

The proposed LCD limiting to just one neurostimulator placement is absolutely flawed and there is no scientific or medical-based evidence behind this statute. Such onerous cost-cutting proposals that are created purely to off-set cost will have detrimental effects in the quality of medical care we provide to the very elderly community who deserve quality medical care.

Peripheral nerve stimulation is a treatment of late/last resort for patients who have failed multiple conservative treatments or is not a candidate for conservative treatment(s), is not a surgical candidate, has obtained psychological clearance, and has had a successful trial to confirm that they will benefit from the therapy long-term prior to permanent implantation of the device.

1. The proposed LCD does not take into consideration decades of clinical research and publications that establishes PNS as a Standard of Care.
2. In what appears to be an oversight, CPT code 64590 is not listed as an approved PNS CPT code. CPT 64590 is integral to the delivery of PNS
3. The FCSO proposed LCD is incongruent with current standards of care as outlined in the long-standing Noridian LCD (L37360) by eliminating coverage for:
1. Mononeuropathies of the extremities and trunk
2. CRPS and causalgia isolated to one major peripheral nerve

The Proposed FCSO LCD will eliminate access to PNS therapies for many patients who have exhausted all other conservative options (late or last resort) which will increase patient dependence on opioids. (Add personal position statement here - the next 2 paragraphs are just my personal statements).

For some time now, CMS has been implementing numerous cost-cutting measures and rules to the LCD that are not based on any scientific evidence which does not fully consider the medical needs of the citizens of this nation. The nation is already in shortage of physicians and due to the numerous brute cost-cutting measures being taken by the CMS that is detrimentally impacting the ability of physicians to provide quality care to American citizens, the rate of physicians who are retiring is only increasing. I recommend a revision of the limitation of the neurostimulator proposal:

Newly Proposed Limitation:

“The implantation of more than two spinal cord stimulator or peripheral nerve stimulator device in the same patient at the same time.18 SCS and PNS device implantation is limited to two spinal cord stimulators and two peripheral nerve stimulators per lifetime per patient, unless the device must be revised or replaced (e.g., due to device malfunction).”

Thank you for the opportunity to comment. I can be reached directly via phone at phone number or via email at email address.

Sincerely,

(Name, Credentials)


**************************************************************************
CMS Proposal

Limitations

Under the following circumstances, the implantation of electrical nerve stimulators (spinal cord or peripheral nerve), or services and supplies related to such implantation, are considered not medically reasonable and necessary:
  1. Patients with a correctable pathology such as nerve entrapment;16,17
  2. Patients who have a current substance abuse disorder;16
  3. Patients with inadequately controlled psychiatric or psychological problems;16
  4. Patients with significant surgical risks such as systemic infection or coagulopathy;16,17
  5. Patients cognitively unable to give informed consent and participate in their care (control the device);16
  6. Patients who are not willing and/or able to follow institutional protocol for follow-up assessments;16
  7. Patients with a life expectancy less than 12 months;16(p578)
  8. Patients who had a negative response to a trial, as evidenced by:
    1. Less than 50% reduction in patient pain from baseline, OR
    2. No objective improvement in functional deficits;1
  9. The use of SCS or PNS for any conditions other than those listed in indications, including post-herpetic neuralgia;15
  10. The implantation of more than one spinal cord stimulator or peripheral nerve stimulator device in the same patient at the same time.18 SCS and PNS device implantation is limited to once per lifetime per patient, unless the device must be revised or replaced (e.g., due to device malfunction);
  11. Peripheral nerve field stimulation (PNFS) for any indication.15,19

You can read the proposal at: Proposed LCD - Nerve Stimulators for Chronic Intractable Pain (DL39404)

Send comments to: [email protected]

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As a young lad I recall my grandpa saying something along the lines of, “If you milk the cow too much it’ll either dry up, kick you, or both.”
 
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Hey everyone,

The time has finally come for the CMS to screw with SCS and PNS LCD

PNS Is being affected, and also the proposal limits SCS/PNS to just ONE TIME per lifetime of the patient.
(1) patient with CRPS of the legs, gets SCS for that, and later it spreads the arms, they are screwed.
(2) Patient with SCS for lumbar postlaminectomy who later gets cervical ACDF but has chronic radic pain in the arm is also SOL.
(3) same goes for shoulder replacement and knee replacement patient with pain in both the shoulder and the knee, etc.



I'm ok with not letting these procedures happen.
 
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Hey everyone,

The time has finally come for the CMS to screw with SCS and PNS LCD

PNS Is being affected, and also the proposal limits SCS/PNS to just ONE TIME per lifetime of the patient.
(1) patient with CRPS of the legs, gets SCS for that, and later it spreads the arms, they are screwed.
(2) Patient with SCS for lumbar postlaminectomy who later gets cervical ACDF but has chronic radic pain in the arm is also SOL.
(3) same goes for shoulder replacement and knee replacement patient with pain in both the shoulder and the knee, etc.

Period for receiving comments is currently open. I recommend anyone who does SCS/PNS should spend the time to send in your comments, and also to send it to your respective legislators.

I've included sample letter below (from my NALU rep), as well as the CMS proposal.

Sample Submission:

Date

Physician Name
Practice
Address
City, State Zip

Via Electronic Submission to [email protected]

RE: Public Comment for Proposed LCD - Nerve Stimulators for Chronic Intractable Pain (DL39406)

First Coast Service Options (FSCO) Medical Directors and Medical Affairs Teams,

I am a (enter specialty/credentials here), and I have been treating patients with chronic intractable pain for X years. (Add additional personal practice content here, such as – do you have a large Medicare population?). After reviewing the FCSO Proposed LCD, Nerve Stimulators for Chronic Intractable Pain, I felt it imperative that I comment on behalf of my patients.

Neurostimulators have proven efficacy for numerous neuropathic conditions and intractable pain conditions. I foresee that the following clause is going to have unnecessary detrimental effects in our ability to provide effective and high quality care of pain management in a large patient population.

I am very concerned about the following LCD proposal of limitation: “The implantation of more than one spinal cord stimulator or peripheral nerve stimulator device in the same patient at the same time.18 SCS and PNS device implantation is limited to once per lifetime per patient, unless the device must be revised or replaced (e.g., due to device malfunction).”

Many chronic pain patients suffer from more than one area of the body with severe intractable pain. Neurostimulator can be used to effectively manage pain in one region, but one neurostimulator does not cover the ‘entire body’. As an example, a patient with history of cervical fusion surgery and leg amputation may suffer from severe pain in the neck as well as phantom limb pain in the leg. Placement of neurostimulator in the cervical spine can help the neck pain but it will not help phantom limb pain in the leg in this instance – in this case a second neurostimulator is required to help the leg pain, but according to the proposed LCD changes limiting to just one neurostimulator per patient in lifetime, the patient will still suffer from intractable phantom limb pain. In this case the patient will be left with no choice but to resort to addictive opioid pain medications which ought not to be the case as the nation is already suffering from problems of opioid addiction.

In the eyes of pain medicine practitioners, the above proposed LCD is akin to stating that a patient with severe osteoarthritis of both knees can only have one knee replaced but not the other. This proposal just does not make any sense.

The proposed LCD limiting to just one neurostimulator placement is absolutely flawed and there is no scientific or medical-based evidence behind this statute. Such onerous cost-cutting proposals that are created purely to off-set cost will have detrimental effects in the quality of medical care we provide to the very elderly community who deserve quality medical care.

Peripheral nerve stimulation is a treatment of late/last resort for patients who have failed multiple conservative treatments or is not a candidate for conservative treatment(s), is not a surgical candidate, has obtained psychological clearance, and has had a successful trial to confirm that they will benefit from the therapy long-term prior to permanent implantation of the device.

1. The proposed LCD does not take into consideration decades of clinical research and publications that establishes PNS as a Standard of Care.
2. In what appears to be an oversight, CPT code 64590 is not listed as an approved PNS CPT code. CPT 64590 is integral to the delivery of PNS
3. The FCSO proposed LCD is incongruent with current standards of care as outlined in the long-standing Noridian LCD (L37360) by eliminating coverage for:
1. Mononeuropathies of the extremities and trunk
2. CRPS and causalgia isolated to one major peripheral nerve

The Proposed FCSO LCD will eliminate access to PNS therapies for many patients who have exhausted all other conservative options (late or last resort) which will increase patient dependence on opioids. (Add personal position statement here - the next 2 paragraphs are just my personal statements).

For some time now, CMS has been implementing numerous cost-cutting measures and rules to the LCD that are not based on any scientific evidence which does not fully consider the medical needs of the citizens of this nation. The nation is already in shortage of physicians and due to the numerous brute cost-cutting measures being taken by the CMS that is detrimentally impacting the ability of physicians to provide quality care to American citizens, the rate of physicians who are retiring is only increasing. I recommend a revision of the limitation of the neurostimulator proposal:

Newly Proposed Limitation:

“The implantation of more than two spinal cord stimulator or peripheral nerve stimulator device in the same patient at the same time.18 SCS and PNS device implantation is limited to two spinal cord stimulators and two peripheral nerve stimulators per lifetime per patient, unless the device must be revised or replaced (e.g., due to device malfunction).”

Thank you for the opportunity to comment. I can be reached directly via phone at phone number or via email at email address.

Sincerely,

(Name, Credentials)


**************************************************************************
CMS Proposal

Limitations

Under the following circumstances, the implantation of electrical nerve stimulators (spinal cord or peripheral nerve), or services and supplies related to such implantation, are considered not medically reasonable and necessary:
  1. Patients with a correctable pathology such as nerve entrapment;16,17
  2. Patients who have a current substance abuse disorder;16
  3. Patients with inadequately controlled psychiatric or psychological problems;16
  4. Patients with significant surgical risks such as systemic infection or coagulopathy;16,17
  5. Patients cognitively unable to give informed consent and participate in their care (control the device);16
  6. Patients who are not willing and/or able to follow institutional protocol for follow-up assessments;16
  7. Patients with a life expectancy less than 12 months;16(p578)
  8. Patients who had a negative response to a trial, as evidenced by:
    1. Less than 50% reduction in patient pain from baseline, OR
    2. No objective improvement in functional deficits;1
  9. The use of SCS or PNS for any conditions other than those listed in indications, including post-herpetic neuralgia;15
  10. The implantation of more than one spinal cord stimulator or peripheral nerve stimulator device in the same patient at the same time.18 SCS and PNS device implantation is limited to once per lifetime per patient, unless the device must be revised or replaced (e.g., due to device malfunction);
  11. Peripheral nerve field stimulation (PNFS) for any indication.15,19

You can read the proposal at: Proposed LCD - Nerve Stimulators for Chronic Intractable Pain (DL39404)

Send comments to: [email protected]

The specialty's super-partners and KOLs will be convening to develop a response.

 
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So if the first stimulator didn’t help, why would a second one?
 
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…. and that’s why we can’t have nice things

On to the next cash cow. Pain cream?
 
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Doesn't sound like this will affect budget too much. Rarely do I see anyone who has or needs 2 devices. But it will suck for those who legitimately do.
 
How can they justify this in the midst of the cluneal neuralgia pandemic?
 
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Actually not terrible news..stim is kinda crap..

Regen works bros..believe what ye may
 
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I don’t fully disagree with you regarding stim, aside from what we all have known to be tried and true, constant neuropathic limb pain.
 
Hey everyone,

The time has finally come for the CMS to screw with SCS and PNS LCD

PNS Is being affected, and also the proposal limits SCS/PNS to just ONE TIME per lifetime of the patient.
(1) patient with CRPS of the legs, gets SCS for that, and later it spreads the arms, they are screwed.
(2) Patient with SCS for lumbar postlaminectomy who later gets cervical ACDF but has chronic radic pain in the arm is also SOL.
(3) same goes for shoulder replacement and knee replacement patient with pain in both the shoulder and the knee, etc.

Period for receiving comments is currently open. I recommend anyone who does SCS/PNS should spend the time to send in your comments, and also to send it to your respective legislators.

I've included sample letter below (from my NALU rep), as well as the CMS proposal.

Sample Submission:

Date

Physician Name
Practice
Address
City, State Zip

Via Electronic Submission to [email protected]

RE: Public Comment for Proposed LCD - Nerve Stimulators for Chronic Intractable Pain (DL39406)

First Coast Service Options (FSCO) Medical Directors and Medical Affairs Teams,

I am a (enter specialty/credentials here), and I have been treating patients with chronic intractable pain for X years. (Add additional personal practice content here, such as – do you have a large Medicare population?). After reviewing the FCSO Proposed LCD, Nerve Stimulators for Chronic Intractable Pain, I felt it imperative that I comment on behalf of my patients.

Neurostimulators have proven efficacy for numerous neuropathic conditions and intractable pain conditions. I foresee that the following clause is going to have unnecessary detrimental effects in our ability to provide effective and high quality care of pain management in a large patient population.

I am very concerned about the following LCD proposal of limitation: “The implantation of more than one spinal cord stimulator or peripheral nerve stimulator device in the same patient at the same time.18 SCS and PNS device implantation is limited to once per lifetime per patient, unless the device must be revised or replaced (e.g., due to device malfunction).”

Many chronic pain patients suffer from more than one area of the body with severe intractable pain. Neurostimulator can be used to effectively manage pain in one region, but one neurostimulator does not cover the ‘entire body’. As an example, a patient with history of cervical fusion surgery and leg amputation may suffer from severe pain in the neck as well as phantom limb pain in the leg. Placement of neurostimulator in the cervical spine can help the neck pain but it will not help phantom limb pain in the leg in this instance – in this case a second neurostimulator is required to help the leg pain, but according to the proposed LCD changes limiting to just one neurostimulator per patient in lifetime, the patient will still suffer from intractable phantom limb pain. In this case the patient will be left with no choice but to resort to addictive opioid pain medications which ought not to be the case as the nation is already suffering from problems of opioid addiction.

In the eyes of pain medicine practitioners, the above proposed LCD is akin to stating that a patient with severe osteoarthritis of both knees can only have one knee replaced but not the other. This proposal just does not make any sense.

The proposed LCD limiting to just one neurostimulator placement is absolutely flawed and there is no scientific or medical-based evidence behind this statute. Such onerous cost-cutting proposals that are created purely to off-set cost will have detrimental effects in the quality of medical care we provide to the very elderly community who deserve quality medical care.

Peripheral nerve stimulation is a treatment of late/last resort for patients who have failed multiple conservative treatments or is not a candidate for conservative treatment(s), is not a surgical candidate, has obtained psychological clearance, and has had a successful trial to confirm that they will benefit from the therapy long-term prior to permanent implantation of the device.

1. The proposed LCD does not take into consideration decades of clinical research and publications that establishes PNS as a Standard of Care.
2. In what appears to be an oversight, CPT code 64590 is not listed as an approved PNS CPT code. CPT 64590 is integral to the delivery of PNS
3. The FCSO proposed LCD is incongruent with current standards of care as outlined in the long-standing Noridian LCD (L37360) by eliminating coverage for:
1. Mononeuropathies of the extremities and trunk
2. CRPS and causalgia isolated to one major peripheral nerve

The Proposed FCSO LCD will eliminate access to PNS therapies for many patients who have exhausted all other conservative options (late or last resort) which will increase patient dependence on opioids. (Add personal position statement here - the next 2 paragraphs are just my personal statements).

For some time now, CMS has been implementing numerous cost-cutting measures and rules to the LCD that are not based on any scientific evidence which does not fully consider the medical needs of the citizens of this nation. The nation is already in shortage of physicians and due to the numerous brute cost-cutting measures being taken by the CMS that is detrimentally impacting the ability of physicians to provide quality care to American citizens, the rate of physicians who are retiring is only increasing. I recommend a revision of the limitation of the neurostimulator proposal:

Newly Proposed Limitation:

“The implantation of more than two spinal cord stimulator or peripheral nerve stimulator device in the same patient at the same time.18 SCS and PNS device implantation is limited to two spinal cord stimulators and two peripheral nerve stimulators per lifetime per patient, unless the device must be revised or replaced (e.g., due to device malfunction).”

Thank you for the opportunity to comment. I can be reached directly via phone at phone number or via email at email address.

Sincerely,

(Name, Credentials)


**************************************************************************
CMS Proposal

Limitations

Under the following circumstances, the implantation of electrical nerve stimulators (spinal cord or peripheral nerve), or services and supplies related to such implantation, are considered not medically reasonable and necessary:
  1. Patients with a correctable pathology such as nerve entrapment;16,17
  2. Patients who have a current substance abuse disorder;16
  3. Patients with inadequately controlled psychiatric or psychological problems;16
  4. Patients with significant surgical risks such as systemic infection or coagulopathy;16,17
  5. Patients cognitively unable to give informed consent and participate in their care (control the device);16
  6. Patients who are not willing and/or able to follow institutional protocol for follow-up assessments;16
  7. Patients with a life expectancy less than 12 months;16(p578)
  8. Patients who had a negative response to a trial, as evidenced by:
    1. Less than 50% reduction in patient pain from baseline, OR
    2. No objective improvement in functional deficits;1
  9. The use of SCS or PNS for any conditions other than those listed in indications, including post-herpetic neuralgia;15
  10. The implantation of more than one spinal cord stimulator or peripheral nerve stimulator device in the same patient at the same time.18 SCS and PNS device implantation is limited to once per lifetime per patient, unless the device must be revised or replaced (e.g., due to device malfunction);
  11. Peripheral nerve field stimulation (PNFS) for any indication.15,19

You can read the proposal at: Proposed LCD - Nerve Stimulators for Chronic Intractable Pain (DL39404)

Send comments to: [email protected]
I sent one out, however in my opinion, PNS has been abused too much, one guy I know he puts in 4 leads at the same time, all migrated in one month, one migrated to the thigh LOL.
 
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Went to rhe asipp course this weekend. PNS seems pretty cool. Supraclavicular and circumflex axillary seem like excellent options for persistent pain after shouldee surgery. Seems like people do a lot of saphenous PNS for knees too
 
Went to rhe asipp course this weekend. PNS seems pretty cool. Supraclavicular and circumflex axillary seem like excellent options for persistent pain after shouldee surgery. Seems like people do a lot of saphenous PNS for knees too
Suprascapular and axillary.

Underwhelming in my tiny experience.
 
Went to rhe asipp course this weekend. PNS seems pretty cool. Supraclavicular and circumflex axillary seem like excellent options for persistent pain after shouldee surgery. Seems like people do a lot of saphenous PNS for knees too
Only saphenous? Seems like that would miss much of the nerve supply.
 
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