1333 H Street, NW Suite 400W Washington, DC 20005 Phone (202) 354-7171 Fax (202) 354-7176 www.medicaldevices.org June 16, 2020

Via Electronic Submission

Robert R. Redfield, MD Director, Centers for Disease Control and Prevention (CDC) Department of Health and Human Services (HHS) 1600 Clifton Road NE, Mailstop S106-9 Atlanta, GA 30329

ATTN: Shannon Lee

RE: Docket Number: CDC-2020-0029

Dear Director Redfield,

On behalf of the Medical Device Manufacturers Association (MDMA), I am pleased to submit MDMA’s comments in response to your request for comment on the management of acute and chronic pain. We applaud the opening of a docket to obtain comments on perspectives and experiences with pain and pain management, and your desire to better understand stakeholders’ values and preferences related to these important issues. We look forward to working collaboratively with you to ensure pain patients have access to opioid-sparing medical devices and the treatments and therapies they enable for acute and chronic pain management. There are hundreds of Food and Drug Administration (FDA) approved or cleared medical devices in the marketplace that can treat acute and chronic pain. Updating CDC’s guidelines to reflect the role of these technologies in managing patients’ pain is critical to accurately describe stakeholders’ values and preferences as well as perspectives and experiences for modern pain management.

MDMA is a national trade association that represents hundreds of companies in the field of medical technology. Our organization provides educational and advocacy assistance to innovative and entrepreneurial medical technology companies, and it is our mission to ensure that patients have timely access to safe and effective medical products that improve health outcomes. Our members, the majority of which are small to mid-sized, research driven medical device companies, have a strong record of delivering innovative therapies to patients suffering from chronic diseases and life-threatening conditions while lowering the cost of care.

Many of these FDA cleared or approved medical device technologies help patients suffering from acute or chronic pain or reduce pain through minimally invasive procedures. Others have been proven to reduce addiction, dependence or withdrawal symptoms as well as the ability to monitor key vital signs and offer care teams early identification of deteriorating patient conditions. Medical devices are a recognized, evidence-based, safe and effective pain treatment option. They should be more accessible to pain patients, and they have a demonstrated ability to reduce opioid use and abuse.

CDC should use this request for comment as an opportunity to update the March 2016 Guideline for Prescribing Opioids for Chronic Pain. The guideline includes references to “alternatives” but does not detail the hundreds of evidence-based, FDA cleared or approved medical devices available to pain patients. An update should appropriately detail the role of medical devices in treating pain. Some of our members’ technologies also carry indications for reducing opioid addiction, dependence or withdrawal symptoms. In addition, as we have indicated previously, many of these technologies can treat acute pain symptoms as well. Oftentimes, the decision to utilize a medical device enabled intervention or pain management protocol over an opioid or alternative treatment protocol comes down to a conversation between a patient and their physician. We support a multi-disciplinary approach to pain management and agree that the ultimate decision should be between the patient and their provider. However, we also believe that opioid-sparing medical device treatment options should be equally accessible to patients as other alternatives. CDC must acknowledge the appropriate role opioid-sparing medical devices play in pain management for patients. This will ensure patient access to those who need them.

Former FDA Commissioner Dr. Scott Gottlieb has testified before Congress that there are over 200 medical devices approved or cleared that have components to treat pain and many more in development. Before the House Energy & Commerce (E&C) Committee he stated, “So there are very interesting, very promising technologies available that could potentially treat chronic and acute pain in ways that don’t lead to the same addiction. And also offer that there’s a lot of medical device alternatives. We’ve [FDA] approved about 200 different medical devices that have components to treat pain, about ten of those are very novel devices, and so we see a lot of opportunity looking across the continuum to medical devices as well to help address painful syndromes, locally rather than systemically.” FDA also established an innovation challenge to identify or develop devices to prevent and treat opioid use disorder. After receiving over 250 applications, the agency is currently working directly with selected applicants to accelerate the development and marketing review. MDMA has also worked with the National Institutes of Health (NIH) to incorporate device research into a NIH initiative to combat the opioid crisis.

An HHS interagency task force, the Pain Management Best Practices Inter-Agency Task Force (Task Force), has also studied the issue of pain, pain management options and alternatives to opioids. In fact, the Task Force was established to propose updates to best practices and issue recommendations that address gaps or inconsistencies for managing chronic and acute pain. The Task Force’s final report, issued May 9, 2019, includes a comprehensive review of acute and chronic pain management in the United States and also recognizes the importance of individualized patient-centered care in the diagnosis and treatment of acute and chronic pain. The report outlines a multi-disciplinary approach; however, it places a greater emphasis on the role of medical device enabled interventional procedures. It also makes the case that earlier referrals to pain specialists will help patients suffering from pain and reduce the burden on primary care physicians who treat patients with other chronic conditions. This shift would be a win-win for all stakeholders. Section 2.4 of the final report is dedicated to interventional procedures, and also details gaps and recommendations to facilitate greater patient access to these opioid-sparing medical devices. MDMA supports the findings and recommendations of this HHS sanctioned report. The next iteration of CDC’s guideline for prescribing opioids must incorporate the report’s findings and recommendations.

Oftentimes, we hear from our members that some of the biggest barriers to appropriate patient access to many of their technologies are challenges associated with establishing appropriate and adequate reimbursement, both with the Centers for Medicare and Medicaid Services (CMS) and private payers. This lag time, or gap, between regulatory approval and clearance for their technologies and securing adequate reimbursement is sometimes referred to as the “valley of death.” It is especially impactful on our small company members, many of whom are trying to bring a single product to the market for patients suffering from acute or chronic pain. As many private payers follow the lead of CMS, this “valley of death” challenge negatively impacts patient access to opioid-sparing medical devices. There are a number of ongoing efforts attempting to remedy this challenge. The Task Force highlighted reimbursement issues as one of its’ gaps and recommendations, and multiple Congressional efforts including the “Comprehensive Addiction and Recovery Act (CARA),” the “Support for Patients and Communities Act (SUPPORT)” and others have included proposals to address the issue. We look forward to a forthcoming CMS Action Plan that will include a review of Medicare and Medicaid payment and coverage policies that may be viewed as potential obstacles to an effective response to the opioid crisis, among other issues.

Medical devices are a recognized, evidence-based, safe and effective treatment option for certain patients who experience acute and chronic pain syndromes. They should be more accessible to patients, and they have a demonstrated ability to reduce opioid use and abuse. Certain technologies also have indications to reduce opioid addiction, dependence or withdrawal symptoms. There are efforts ongoing in the federal government to provide greater access to some of these technologies; however, those efforts are at times disconnected. The opioid crisis continues to be a health threat to our nation, and the lack of patient access to opioid-sparing medical technologies sadly is contributing to suffering in far too many communities across our country. The CDC, as the nation’s preeminent body charged with protecting America from health, safety and security threats, is well positioned to lead a coordinated and connected effort that enables greater patient access to opioid alternatives, including the appropriate role of opioid- sparing medical devices.

We thank you for this timely request for comment and the opportunity to provide our perspectives. We hope this will initiate a revision to the 2016 Guideline for Prescribing Opioids for Chronic Pain and that revision includes specific acknowledgements of the appropriate role for opioid-sparing medical devices in chronic pain management. We also hope you will consider a separate exercise for acute pain management. The educational components to patients and providers that will stem from a comprehensive update cannot be overstated. It will also serve as a strong signal to other federal agencies that their policies and guidelines must be re-aligned. Ultimately, patients will benefit. We look forward to working with you on behalf of all the patients we mutually serve.

Sincerely,

Mark B. Leahey President & CEO, MDMA

P.s. while not an exhaustive list, included as an appendix to this letter is a list of technologies within our membership that have components to treat acute and chronic pain and serve as alternatives to opioids.

Appendix: Medical Technology Product Categories for Pain Management and/or Opioid Alternatives:

**Please note, technologies are presented alphabetically

Basivertebral Nerve (BVN) Ablation: • Basivertebral nerve (BVN) ablation is the use of RF energy to ablate the basiverterbal nerve, which is an intraosseous nerve located in the vertebrae; • BVN ablation is indicated for chronic vertebrogenic low back pain that is identified by Modic Type 1 or 2 changes on an MRI; • BVN ablation is supported with 2 Level I randomized control trials including long term durability.

Continuous Peripheral Nerve Block (cPNB): • Uses an infusion catheter to pump anesthetics during a procedure, which reduces pain during and after a surgery.

Cryo nerve block / CryoNB: • Temporary freezing of nerves at incision site during surgery for post-operative pain management; • Treatment provides immediate, long-lasting pain relief by blocking the nerve’s ability to transmit pain signals without affecting the structure of the targeted nerve. The procedure adds up to 15 minutes per surgery; • Potential acute surgical benefits include reduction in opioid pain medication, less patient pain, reduced length of stay, and quicker recovery; • It has been well proven to be safe and effective as a stand-alone, non-opioid modality for managing chronic, perioperative and acute pain.

Epidural/Spinal: • An injection of local anesthetic or continuous delivery of anesthetics that can manage pain before, during and after surgery.

Interspinous Process Devices: • Minimally invasive treatment for lumbar spinal stenosis; • Can be offered in the inpatient, outpatient or ASC setting; • Effective in relieving persistent pain, numbness and/or cramping in the legs. Clinical evidence of benefit/risk and cost effectiveness is extensive; • Patient population largely consists of Medicare beneficiaries but only limited Medicare coverage to date.

Less Invasive Surgical Procedures: • Patients who are in chronic pain can often be treated effectively using minimally invasive surgical procedures. Many of these can be performed in an hour or less. For example, 31 million people in the United States suffer from lower back pain each year. Many peer- reviewed technologies can address this problem, but they are not covered by payers, denying patients access to life-changing therapies. Studies show less invasive procedures lead patients to having an 11-times less likelihood of reliance on opioids.

Low-Level Laser: • Non-invasive low-level laser is FDA indicated for temporary relief of pain specifically for chronic neck & shoulder, chronic plantar fasciitis, chronic low back and nociceptive musculoskeletal pain; • Proven through (3) separate level 1 studies (Double Blind, Placebo Controlled, Randomized).

Magnetic Sensory Nerve Block: • Low cost, low risk, non-toxic, noninvasive, non-pharmacological quadrapolar magnetic disc for stabilizing cell membranes to blockade the transduction of pain signals produced by a low power magnetic array, arranged in alternating polarity, to generate a unique steep field gradient.

Non-invasive Vagus Nerve Stimulation: • Non-invasive vagus nerve stimulation is indicated for the treatment of the pain associated with episodic cluster headache and migraine headache in adults; • Technology provides a mild electrical stimulation of the vagus nerve, which runs through the neck and carries information to the central nervous system; • Each stimulation lasts two minutes (120 seconds). The patient controls the stimulation intensity; • Published information has identified that opioids are frequently administered to headache patients despite not being indicated; • A recent study indicated that 37% of these patients receive an opioid prescription at ER visits for migraine, despite not being indicated. Vagus nerve stimulation offers a non- opioid option for these patients.

Opioid Disposal Technology: • Technology that securely captures partially administered or unused controlled substances and renders them non-retrievable and unusable; • Helps reduce drug diversion and improve patient safety while also reducing the impact on the environment; • The technology is conveniently sized to fit on anesthesia carts, in operating rooms, procedure rooms, nursing stations, EMS vehicles and other locations where liquid medications are administered by healthcare professionals.

Percutaneous Electrical Nerve Field Stimulation (PENFS): • FDA-cleared non-surgical system, with pre-programmed 120-hr. duty cycle, which stimulates the Amygdala and spinal cord; • Lead-array is percutaneously implanted in outpatient setting, without the need for sedation, modulating the cranial nerve branches in the external ear; • Pediatric indication for Functional Abdominal Pain associated with IBS in 11-18 y/o patients; • Several publications, including a randomized controlled trial (RCT), report clinically and statistically significant reductions in functional abdominal pain in adolescent patients.

Peripheral Nerve Stimulation (PNS): • FDA-cleared systems include those that are temporarily or permanently implanted; • A lead is percutaneously implanted by an interventional pain management physician using fluoroscopic or ultrasound-guidance while the patient is awake and without the need for sedation; • The lead is powered by an external or implanted pulse generator that is controlled with a small Bluetooth® enabled patient remote control; • More than 20 publications, including 4 randomized controlled trials (RCTs), report clinically and statistically significant reductions in chronic pain. Other findings include the demonstrated ability of PNS to reduce opioid consumption, decrease pain interference, and improve quality of life.

Radio Frequency Ablation (RFA): • A minimally invasive special needle is inserted into the area of pain and a radiofrequency current is created using specialized equipment and delivered to the pain nerve providing 6 – 12 months of ongoing pain relief; • This therapy is used to lesion neural tissue and is most commonly used in the lumbar and cervical spine regions and has been supported by numerous studies over several decades of use; • More recently this therapy has been used to treat chronic pain in the knees, hips and shoulders; • Cost-effective treatment option serves as an alternative to surgery and/or opioids.

Smart Pump Continuous Peripheral Nerve Block: • Uses an infusion catheter to pump anesthetics for pain management during a procedure and continues at a low dose for two to five days after surgery; • The ability to manage pain reduces and/or eliminates the need to prescribe patients opioids.

Spinal Cord Stimulators (SCS): • Minimally invasive and reversible neuromodulation treatment that uses electrical signals to block pain signals from reaching the brain; • The system is a minimally invasive implant (similar to pacemaker technology) and is trialed for efficacy before a patient receives a permanent implant to verify that they gain therapeutic benefit before surgery; • High-Frequency Spinal Cord Stimulators (as defined by operating at 10,000 Hz or HCPCS C1822) have demonstrated statistically significant opioid reduction and opioid elimination at both 12 and 24-month endpoints; • High-Frequency Spinal Cord Stimulators have also demonstrated statistically significant opioid reduction for high-risk opioid users as defined by CDC guidelines (those with daily MME > 90mg); • SCS has helped 500,000+ patients who have reported a 50 percent or greater reduction in pain and use of pain medication, improving quality of life and reducing disability; Numerous high-quality studies support the efficacy and safety of this procedure in the treatment of refractory chronic pain; • SCS studies have shown a significant pain reduction in patients with reduction in opioid usage long-term and higher health care utilization and costs overall associated with longer delay from onset of chronic pain to SCS; • Recent advances in this technology have led to FDA approval of an offshoot technology to SCS, dorsal root ganglion (DRG) stimulation, which, in a large RCT pivotal trial, has been shown to have over an 80% reduction in pain at 12 months. These results have been replicated worldwide in numerous large prospective studies.

Targeted Drug Delivery (TDD) – Implantable Pain Pumps: • A retrospective claims analysis (n=389) found that 51 percent of chronic non-malignant pain patients eliminated systemic opioids within one year of TDD therapy; • This elimination resulted in a 10% to 17% reduction in yearly inpatient, outpatient, and drug expenditures; • A smaller, single-center, retrospective chart review (n=99) of patients with chronic non- malignant pain who agreed to transition from systemic opioids to TDD with the goal of eliminating systemic opioids, demonstrated that 84 percent of patients were able to eliminate systemic opioids after 12 months when using TDD to relieve their chronic pain.

Virtual Embodiment Training: • Non-invasive, non-pharmacological form of movement retraining for patients with chronic pain suffering from motor/autonomic impairments and central sensitivity; • Patients are able to perform corrective exercises in virtual reality seeing their bodies in a first-person view; • Technology that captures movement data and displays in reports to show functional range of motion improvements.

Viscosupplementation: • Viscoelastic products are sterile solutions of highly purified, high molecular weight (0.5- 6.0 MM Daltons) hyaluronan, HA, (also known as sodium hyaluronate) in phosphate- buffered saline, injected into the intraarticular space as a single or 3-5 weekly injections as a course of treatment; • Regulated as a Class III medical device since 1997 because of its mechanical properties of improving lubrication, cushioning and resistance to shear; • Indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen); • A single course of injections can provide 6 months or more of pain relief and repeat treatment has been shown to be safe with > 200MM injections administered worldwide; • Local treatment with no known interactions with systemic drugs; • Meta-analysis of claims data suggest that HA therapy may delay knee replacements in OA patients by as much as 3.6 yrs; reduces use of pain medications, including opioids.