August 20, 2026 

Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 

Re: CMS-1850-P — Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; CY 2027 Proposed Rule 

Dear Administrator: 

The Women Innovators in Pain Management (WIPM) represents female medical providers who practice across multiple practice settings, medical specialties and stages of their careers. We are united in the mission to encourage and empower women who are committed to leading and providing optimal pain management care to our patients. We appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) Calendar Year (CY) 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule, CMS-1850-P. 

As a society, we share CMS’s objective of promoting efficient use of Medicare resources, expanding access to appropriate outpatient care, and reducing unnecessary site-of-service spending. As front-line providers who often care for the most vulnerable patients in our healthcare systems, we are also concerned with preserving evidence-based alternatives to opioid therapy and the medical provider’s judgement regarding treatment decisions. This includes the most appropriate setting of care for our patients. 

As such, our comments relating to CMS-1850-P focus on the following concerns: (1) continued access to neuromodulation procedures; (2) payment policies that stand to influence site of service for patients; (3) the potential that reduced access to peripheral nerve stimulation procedures may induce clinical practice patterns that increase healthcare costs and patient burden. 

1. Continued access to neuromodulation procedures that are Proven to Reduce Opioid Use 

We recognize CMS’s obligation to maintain budget neutrality. Nevertheless, as device-intensive procedures represent an increasing portion of ambulatory procedural care, CMS should closely evaluate whether the interaction between device payment and budget-neutrality adjustments adequately supports resources required to safely deliver these therapies. 

2. Payment policies Stand to Influence Site of Service 

We are experiencing a widening payment gap between Ambulatory Surgery Centers (ASC) and Hospital Outpatient Procedure Departments (HOPD) reimbursement rates. On June 3, 2026, Becker’s ASC Review, reported that since 2019, ASCs have experienced a progressive reimbursement reduction to now 85 percent of HOPD reimbursements for the same procedures. Disparate rewards have influenced a trend toward major health systems acquiring independent physician practices and physicians becoming hospital-employees or shifting cases directly to hospital-owned facilities. 

We strongly support CMS’s longstanding recognition that site-of-service decisions should incorporate physician judgment and individualized assessment of procedural risk. CMS has previously emphasized that physicians and hospitals should consider the individual patient, the procedure, and the site of service when determining the appropriate setting of care. 

As written, the proposed changes within CMS-1850-P stand to increase the ASC- HOPD reimbursement gap. Further, WIPM is concerned about this trend due to the issues it poses with regards to patient access. Patients living in rural areas often depend on independent private practices including associated ASCs. Even for those patients with the fortune to have access to either site of service, this selection should be founded in patient-centered factors. 

3. Restricted Reimbursement for Second Neuromodulation Lead 

The proposed policy change reduces reimbursement for a second spinal cord stimulation lead. The placement of the second lead is not ancillary, but necessary and standard for performance of neuromodulation. The work of placing the second lead is not diminished compared to the first. Therefore, it is not reasonable to reduce reimbursement for this portion of the procedure. Additionally, this policy change limits physicians to implantation of a single peripheral nerve stimulation lead. We recognize that in most instances, a single lead would be sufficient. Still, there are instances in which a second peripheral nerve stimulator lead is clinically appropriate to treat a patient’s presenting pathology. As the clinical experts, physicians should retain autonomy in this decision and not be financially incentivized to reduce the quality neuromodulation care. 

In summary, we respectfully request that CMS: 

1. Not limit procedural access in ASCs and other outpatient environments and preserve individualized, physician-directed site-of-service selection. 

2. Maintain transparent and clinically meaningful pathways for emerging neuromodulation technologies, ensuring that existing device categories are neither so narrow as to create unnecessary fragmentation nor so broad that they fail to recognize materially different technologies. 

3. Continue engaging interventional pain physicians and relevant specialty stakeholders when developing payment policies affecting image-guided procedures, neuromodulation, non-opioid therapies, and other advanced outpatient interventions. 

4. Not reduce compensation for second spinal cord stimulator and peripheral nerve stimulator leads. 

We appreciate CMS’s continued efforts to modernize outpatient payment policy while improving beneficiary access, affordability, and quality. Interventional pain medicine occupies an increasingly important role in providing non-opioid and minimally invasive treatment options for Medicare beneficiaries, and payment policy should continue to support delivery of these treatments in the safest, most clinically appropriate, and most efficient setting. 

Thank you for the opportunity to comment on CMS-1850-P. We welcome continued engagement with CMS regarding the impact of these policies on interventional pain care and Medicare beneficiaries. 

Sincerely, 

Women Innovators In Pain Management Board of Directors & Policy and Advocacy Committee 

References: 

1. West T, et al. Pain intensity and opioid consumption after temporary and permanent peripheral nerve stimulation: A 2-year multicenter analysis. Reg Anesth Pain Med. 2025 Nov 5;50(11):865-872 

2. Soleymani H, et al. Change in opioid use following spinal cord stimulation: A systemic review and meta-analysis. Reg Anesth Pain Med. 2026:rapm-2026-107603. 

 WIPM POSITION STATEMENT

Implantable Peripheral Nerve Stimulation (PNS)

The Society of Women Innovators in Pain Management (WIPM) represents women who participate in research, advocacy and delivery of pain management care. As an element of advocacy, the Society is attentive to supporting therapies that are proven beneficial in treatment of patients suffering with chronic pain. As such, WIPM firmly advocates for the utilization of temporary and permanent Peripheral Nerve Stimulation (PNS) devices as standard of care in the comprehensive management of patients suffering from moderate to severe chronic pain who have continued to experience moderate to severe chronic pain following two or more conventional treatments.

Recognizing the limitations of existing treatments and the imperative to alleviate patient suffering, WIPM underscores the following key points:

  • Access and Eligibility: WIPM emphasizes the importance of facilitating access to PNS devices for patients who can derive significant benefit from them. Patients who have endured persistent pain despite more conservative interventions such as physical therapy, injections, ablation and oral analgesics should have the opportunity to explore PNS as a viable alternative. PNS devices that have achieved FDA clearance and demonstration of positive outcomes published in peer-reviewed journals, especially those with randomized controlled trials and a significant body of real-world evidence should be readily accessible to eligible patients.

  • Safety and Efficacy: The safety profile of PNS devices is well-established, with longitudinal data supporting its efficacy and durability. WIPM acknowledges the substantial body of clinical evidence validating the effectiveness of PNS across various pain syndromes, including neuropathic and non-neuropathic conditions.

  • Contrary to its unfortunate characterization by some payers, PNS is not an experimental or investigational treatment; rather, it represents a clinically validated approach endorsed by numerous peer-reviewed publications.  The following PNS systems have achieved FDA clearance:

    • StimRouter System – Bioventis

    • SPRINT PNS System – SPR Therapeutics

    • Freedom PNS System – Curonix

    • Nalu PNS System – Nalu Medical

In light of the compelling clinical evidence and regulatory clearance, WIPM recommends the judicious utilization of PNS by qualified healthcare professionals.  Policymakers and payers are urged to facilitate timely access to FDA-cleared PNS technologies, ensuring that patients receive optimal care based on clinical need and evidence-based practice.

Finally, given the above:

WIPM considers temporary implantation of PNS leads medically necessary for patients with chronic, intractable pain when all of the following criteria are met:

  1. The PNS treatment is provided in accordance with FDA guidelines and indications; and,

  2. Patient has chronic pain (present for >6 months), refractory to, at minimum, two conservative methods of treatment including but not limited to:

a. Oral NSAIDs/Analgesics/Gabapentinoids > 3 weeks unless contra-indicated;
b. Activity modification > 6 weeks;
c. Physical therapy (minimum of 4 visits within a 3-month period);
d. Injection therapy (e.g. steroid injection, nerve block, radiofrequency ablation)

WIPM further considers permanent implantation of PNS systems medically necessary for patients with chronic, intractable pain when all of the following criteria are met:

  1. The PNS treatment is provided in accordance with FDA guidelines and indications;

  2. Patient has chronic pain (present for >6 months), refractory to, at minimum, two conservative methods of treatment including but not limited to:

a. Oral NSAIDs/Analgesics/Gabapentinoids > 3 weeks unless contra-indicated;
b. Activity modification > 6 weeks;
c. Physical therapy (minimum of 4 visits within a 3-month period);
d. Injection therapy (e.g. steroid injection, nerve block, radiofrequency ablation)

3. Patient has achieved at least 50% pain relief with temporary PNS

4. Pain relief was not sustained following withdrawal of the temporary lead, or when moderate to severe pain has returned post lead withdrawal.

Key References:

  • Randomized Controlled Trials (RCTs)

    • Chae, J., David, T.Y., Walker, M.E., Kirsteins, A., Elovic, E.P., Flanagan, S.R., & Fang, Z.P. (2005) Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. American journal of physical medicine & rehabilitation, 84(11), 832-842.

    • Wilson, R.D., Gunzler, D.D., Bennett, M.E., & Chae, J. (2014). Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized controlled trial. American journal of physical medicine & rehabilitation/Association of Academic Physiatrists, 93(1), 17.

    • Deer, T., Pope, J., Benyamin, R., Vallejo, R., Friedman, A., Caraway, D., ... & Mekhail, N. (2016). Prospective, multicenter, randomized, double‐blinded, partial crossover study to assess the safety and efficacy of the novel neuromodulation system in the treatment of patients with chronic pain of peripheral nerve origin. Neuromodulation: Technology at the Neural Interface, 19(1), 91-100.

    • Gilmore CA, Ilfeld BM, Rosenow JM, Li S, Desai MJ, Hunter CW, Rauck RL, Nader A, Mak J, Cohen SP, Crosby ND, Boggs JW. (2020). Percutaneous 60-day Peripheral Nerve Stimulation Implant Provides Sustained Relief of Chronic Pain Following Amputation: 12-month Follow-Up of a Randomized, Double-Blind, Placebo-Controlled Trial. Regional Anesthesia and Pain Medicine, 2020; 45:44-5.

  • Literature./Systematic Reviews:

    • Deer TR, et. al. “A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain”. Pain Medicine. (2020). August; 21(8): 1590- 1603.

    • Xu, J., Sun, Z., Wu, J., Rana, M., Garza, J., Zhu, A. C., ... & Cheng, J. (2021). Peripheral nerve stimulation in pain management: a systematic review. Pain Physician, 24(2), E131.

    • Helm S. et. al. “Peripheral Nerve Stimulation for Chronic Pain: A Systematic Review of Effectiveness and Safety”. Pain and Therapy. 2021. Dec;10(2): 985-1002.

    • Strand N. et. al. “Evidence -Based Guidelines from the American Society of Pain and Neuroscience for the Use of Implantable Nerve Stimulation in the Treatment of Chronic Pain”. Journal of Pain Research. 2022. August 23; 15: 2483-2504.

  • Other Significant PNS Publications:

    • Naidu R, Li S, Desai MJ, Sheth S, Crosby ND, Boggs JW. (2022) 60-Day PNS Treatment May Improve Identification of Delayed Responders and Delayed Non-Responders to Neurostimulation for Pain Relief, Journal of Pain Research, March 2022.

    • Gilligan, et. al. (2023) “Long Term Outcomes of Restorative Neurostimulation in Patients with Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two Year Results of the ReActiv8-B Pivotal Trial”. Neuromodulation. 2023. January; 26(1): 87-97.

    • Gilmore CA, Deer TR, Desai MJ, Hopkins TJ, Li S, DePalma MJ, Cohen SP, McGee MJ, Boggs JW. (2023). Durable patient-reported outcomes following 60-day percutaneous peripheral nerve stimulation (PNS) of the medial branch nerves, Interventional Pain Medicine, March 2023.

    • Huntoon MA, Slavin KV, Hagedorn JM, Crosby ND, Boggs JW. (2023). A Retrospective Review of Real-world Outcomes Following 60-day Peripheral Nerve Stimulation for the Treatment of Chronic Pain, Pain Physician, May 2023.

    • Dickerson DM, Kalia H, Vorenkamp K, Gunnarsson C, Epstein AJ, Keuffel EL, Stultz M, Crosby ND, Huntoon MA. (2024). Cost Benefits of Medicare Patients Receiving 60-Day PNS Treatment Versus Other Forms of Permanent PNS. (North American Neuromodulation Society Annual Meeting, January 2024). Manuscript submitted for publication.