June 16, 2016

BlueCross BlueShield of Tennessee

Medical Policy
1 Cameron Hill Circle
Chattanooga, TN 37402
Re: HF10 Spinal Cord Stimulation Therapy
To whom it may concern:
We are writing on behalf of the American Society of Regional Anesthesia and Pain Medicine (ASRA),
one of the largest subspecialty medical societies in anesthesiology, with more than 4,000 members.
Recently it has come to our attention, through an April 2016 Highmark and Blue Cross Blue Shield
medical policy, that high frequency -10,000 Hz (HF-10) spinal cord stimulation (SCS) therapy will be
considered experimental and investigational. We are disappointed in this new labeling and request that
Blue Cross Blue Shield remove this labeling in order provide appropriate, optimal medical care for their
beneficiaries through access to this evidence-based therapy when deemed medically necessary.
Consider the following:
The amount of Americans (11.4%) who suffer from chronic pain is larger than those with
diabetes (9.3%).[1,2] We know you would not deny an appropriate treatment for diabetes with a
demonstrated improved outcome. We are asking for similar consideration for HF-10 for chronic
pain.
Recent advancements in SCS, specifically in electrical parameter adjustments (e.g., high
frequencies) and programming, have significantly advanced the efficacy and safety of this
treatment modality.
Use of nonopioid interventions for chronic pain are essential in light of the current opioid crisis in
America. Mortality and morbidity associated with opioid use for chronic pain is higher than that
of automobile accidents, and, in a recent JAMA paper3, long-acting opioids were associated with
increased mortality from cardiorespiratory and other causes. The #1 recommendation in the CDC
Guideline for Prescribing Opioids for Chronic Pain4 states that nonpharmacologic therapy and
nonopioid pharmacologic therapy are preferred for chronic pain.

American Society of Regional Anesthesia and Pain Medicine

Advancing the Science and Practice of Regional Anesthesia and Pain Medicine
Four Penn Center West | Suite 401 | Pittsburgh, PA 15276 | www.asra.com

Advancements in SCS
Over the last 30 years, significant advancements have occurred in SCS, specifically in electrical
parameter adjustments (e.g., higher frequencies) and programming, which have enhanced the efficacy of
the treatment. One recent advancement is the utilization of HF-10. Both preclinical5,6 and clinical
evidence7-11 strongly support the analgesic efficacy and safety of HF-10 therapy to effectively modulate
chronic low back and neuropathic pain.
Preclinical work: Schechter et al.5, demonstrated the ability of HF-10 therapy to effectively inhibit
mechanical hypersensitivity in a neuropathic pain animal model. Song et al.6 established that both
conventional SCS (low frequency) and HF-10 were effective in various animal neuropathic pain models.
Clinical evidence: High-quality clinical data demonstrates the therapeutic safety and sustained efficacy of
HF-10 therapy.7,9-11 HF-10 therapy received European regulatory approval in 2010. Since 2010, more than
2,000 patients have been implanted with HF-10 systems with great success.11 In 2013 in an open-label
cohort study examining 83 patient with significant back pain, Van Buyten et al.8 reported sustained low
back pain and leg pain relief in greater than 70% of treated subjects. Not only did patients have significant
improvement in pain relief, but they also demonstrated improvements in disability and sleep. In a 24month, multicenter study, Al-Kaisy et al.,9 demonstrated statistically significant, sustained efficacy of HF10 therapy with mean back pain scores (VAS) going from 8.4 0.1 at baseline to 3.3 0.3 at 24 months.
Mean leg pain decreased from 5.4 0.4 to 2.3 0.3.
Kapural et al.,7 in a pivotal randomized-controlled trial (RCT), published in the high quality and reputable
journal Anesthesiology, compared HF-10 therapy to traditional, low-frequency SCS and found HF-10
therapy to be superior to traditional low-frequency SCS in the treatment of chronic back and leg pain. The
HF-10 treatment subjects had greater pain relief at 12 months (78.7% reduction for HF-10 vs. 51.3% for
traditional SCS). In addition, after HF-10 therapy, 67% of the subjects were considered back and leg pain
remitters (defined as pain scores 2.5) over the 12-month follow-up period. This is a significant clinical
improvement and should put in context with pharmacologic management of neuropathic pain, in which
less than 50% of patients find significant improvement with any medication.12 This study was used in
support of the FDA approval for HF-10 therapy and is one of the largest ever conducted RCTs of SCS
interventional pain therapy with a long-term follow-up.
In addition to the peer-review process, both the Food and Drug Administration (FDA) and CMS have
recognized the high quality of this clinical trial, with the FDA granting the labeling of HF10 as superior
to traditional SCS based on the study results. Furthermore, the significance of this RCT should be
reference to the current literature of SCS therapy. To date, this study is one of four RCTswith at least 6
months observationin the SCS literature. In a recent systematic review by Grider et al.,13 which
performed a methodological assessment of RCTs evaluating SCS in chronic pain, the Kapural et al.7 study
received the highest quality score.
In addition to its clinical efficacy, HF-10 therapy in a healthcare economic model of SCS demonstrated a
favorable incremental cost-effective ratio per quality-adjusted life-years (QALY) gained in comparison to
conventional medical management and established dominance compared to traditional SCS.14
We have been informed that Blue Cross Blue Shield, when evaluating HF-10 therapy, has inappropriately
included the Perruchoud et al.15 study. This study should not be used to evaluate the efficacy of HF-10
therapy. This study was only a two-week trial examining an experimental device modified to examine
the efficacy of 5000 Hz SCS in individuals previously successfully treated with traditional SCS therapy.
Significant differences exist for the equipment used in this study compared to HF-10 therapy including
frequency, waveform, programming, and lead placement. In addition, CMS has specifically defined
high-frequency SCS as required to deliver a frequency of 10,000 Hz. The device utilized in the

Perruchoud et al.15 study delivered half of this frequency, and, therefore, should not be used to evaluate
the efficacy of HF-10 therapy.
The Opioid Epidemic
With the current opioid epidemic in the United States, any and all nonopioid therapy (e.g., SCS HF-10)
should be attempted on patients with chronic pain prior to considering long-term opioid therapy. In fact,
the recently published CDC Guideline for Prescribing Opioids for Chronic Pain4 recommends that
alternative treatments be considered prior to prescribing opioids for chronic pain. HF-10 is one such
treatment that physicians should be able to consider. Furthermore, by using HF-10 or other similarly valid
interventions, physicians are potentially able to help prevent more serious complications. For example, a
new study published in JAMA found a significantly increased risk of all-cause mortality, specifically
cardiovascular deaths, in patients receiving long-acting opioids.3
In conclusion, significant preclinical and clinical data demonstrate the safety and efficacy of HF-10
therapy, and this modality is precisely the sort of treatment that the CDC Guideline recommends in light
of the opioid crisis in America. It is of critical clinical importance that Blue Cross Blue Shield reverses its
decision to classify HF-10 therapy as experimental and investigational. HF-10 therapy has been shown to
provide significant pain relief to appropriately selected individuals with chronic pain conditions that are
often challenging to treat. In addition, the therapy offers advantages in select individuals to traditional
SCS therapy including the ability to deliver paresthesia-free pain control that does not limit activities
including driving.
Thank you in advance for your assistance with this matter. Please feel free to contact us with further
questions or comments.
Sincerely,

Oscar de Leon Casasola, MD

President, American Society of Regional Anesthesia and Pain Medicine

References
1. Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and
Education. Relieving pain in America. A blueprint for transforming prevention, care, education
and research. The National Academies Press, 2011. Available from
http://books.nap.edu/openbook.php?record_id=13172&page=1. Accessed June 16, 2016.
2. American Diabetes Association. Statistics about diabetes. Available from
http://www.diabetes.org/diabetes-basics/diabetes-statistics/ Accessed June 16, 2016.
3. Ray WA, Chung CP, Murray KT, Hall K, Stein M. Prescription of long-acting opioids and
mortality in patients with chronic noncancer pain. JAMA 2016; 315:2415-23. doi:
10.1001/jama.2016.7789

4. Dowell D, Haegerich TM, Chou R. CDC guideline for prescirbing opioids for chronic pain
United States 2016. MMWR Recomm Rep 2016;65:1-14. doi: 10.15585/mmwr.rr6501e1
5. Shechter R, Yang F, Xu Q, et al. Conventional and kilohertz-frequency spinal cord stimulation
produces intensity- and frequency-dependent inhibition of mechanical hypersensitivity in a rat
model of neuropathic pain. Anesthesiology 2013; 119: 422-32.
6. Song Z, Viisanen H, Meyerson BA, Pertovaara A, Linderoth B. Efficacy of kilohertz-frequency
and conventional spinal cord stimulation in rat models of different pain conditions.
Neuromodulation 2014; 17: 226-34; discussion 234-5.
7. Kapural L, Yu C, Doust MW, et al. Novel 10-kHz high-frequency therapy (HF10 therapy) is
superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and
leg pain: The SENZA-RCT randomized controlled trial. Anesthesiology 2015; 123: 851-60.
8. Van Buyten JP, Al-Kaisy A, Smet I, Palmisani S, Smith T: High-frequency spinal cord
stimulation for the treatment of chronic back pain patients: Results of a prospective multicenter
European clinical study. Neuromodulation 2013; 16: 59-65; discussion 65-6.
9. Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10
kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month
results of a prospective multicenter study. Pain Med 2014; 15: 347-54.
10. Russo M, Verrills P, Mitchell B, Salmon J, Barnard A, Santarelli D. High frequency spinal cord
stimulation at 10 kHz for the treatment of chronic pain: 6-month Australian clinical experience.
Pain Physician 2016; 19: 267-80.
11. Russo M, Van Buyten JP. 10-kHz High-frequency SCS therapy: A clinical summary. Pain Med
2015; 16: 934-42.
12. Dworkin RH, Backonja M, Rowbotham MC, et al. Advances in neuropathic pain: diagnosis,
mechanisms, and treatment recommendations. Arch Neurol 2003; 60: 1524-34.
13. Grider JS, Manchikanti L, Carayannopoulos A, et al. Effectiveness of spinal cord stimulation in
chronic spinal pain: A systematic review. Pain Physician 2016; 19: E33-54.
14. Annemans L, Van Buyten JP, Smith T, Al-Kaisy A. Cost effectiveness of a novel 10 kHz highfrequency spinal cord stimulation system in patients with failed back surgery syndrome (FBSS). J
Long Term Eff Med Implants 2014; 24: 173-83.
15. Perruchoud C, Eldabe S, Batterham AM, et al. Analgesic efficacy of high-frequency spinal cord
stimulation: A randomized double-blind placebo-controlled study. Neuromodulation 2013; 16:
363-9; discussion 369.