Pain Management Task Force Meeting with CMS
2019-07-08 2019-07-08 2019-06-12 2019-07-08 2019-06-24 2019-07-08 2019-06-24 2019-06-24 2019-06-24
HHS-OS-2019-0008-0027 HHS-OS-2019-0008-0025 HHS-OS-2019-0008-0002 HHS-OS-2019-0008-0013 HHS-OS-2019-0008-0003 HHS-OS-2019-0008-0024 HHS-OS-2019-0008-0005 HHS-OS-2019-0008-0006 HHS-OS-2019-0008-0007
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0027 https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0025 https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0002 https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0013 https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0003 https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0024 https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0005 https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0006 https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0007
Curtis Nir Paul Christopher Robert Molly Michael Gwendolyn Anonymous
Quinn Hus Ross Towe Sheerin Giammarco Ferguson Poles Anonymous
Dear Sirs and Madams,I am a Thoracic surgeon in Manchester NH and want to share my experience with you regarding Cryo-analgesia nerve block application for post thoracotomy and VATS lung surgery pain. I have been utilizing the Atricure Cryo-sphere prob for the last six years on over 400 cases of both thoracotomy and Minimally invasive VATS and robotic cases. I have seen a dramatic reduction in post operative narcotic requirement post op in many cases No narcotics have been needed. A recent study published in the AATS journal has shown that 14% of post thoracotomy and 9% min invasive VATS lung surgery patients are at sig risk for opiod addiction. I have just submitted an abstract to the AATS for publication demonstrating that in a single institution case comparison review we document a overall five fold reduction in post op narcotic use in patients who received cryo-analgesia. This highly effective procedure is not reimbursed for as such the hospital has to absorb the cost for the technology. I believe it would be much more utilized across the US if hospitals could be appropriately reimbursed. This procedure has added a critical advantage in my post operative care with improved outcomes and significantly reduced need for narcotics.Please feel free to contact me if you have further questions.Thank you,SincerelyCurt Quinn Hello,I am a trauma surgeon working in two busy level one trauma centers in Florida, Delray Medical center and St. Marys medical center, Florida. As a trauma surgeon I encounter and treat the widest range of all  conceivable causes of acute and chronic pain. From the cancer patient that in addition to the chronic pain due to  cancer has suffered a traumatic event due to a motor vehicle crash.  A gunshot victim that has acute pain due to the devastating injury Which then will be complicated by expected chronic pain.  The child that was burned in a family barbecue in over 30% of her body, and many more. We have great solutions to help manage acute pain but when it comes to chronic / prolonged pain especially in trauma we try to decrease over use of narcotics.  I would like to bring forth to the committee additional modality for pain control that has been overlooked and in my experience has decreased my narcotic outpatient prescription by more than 80%.  This Remarkable decrease in the use of narcotics were specifically affective patients that suffered severe traumatic chest wall injury.   Cryo-ablation, Nurolysis of intercostal (thoracic) nerves  by means of freezing the nerves provides relief from pain from an approximate. 4 to 5 months.  This new approach has reduced my dispensing narcotic practice by more than 80%. This is a remarkable amount. The major impediment to allow even wider use of this technology is directly related to the lack of reimbursement.   The side effects is numbness at the injured site for a period of 4 to 5 months followed by  recovery of the sensation at the injured site long past the time that the injury required to heal. while obviating the need for narcotics to aid in pain  management. Please consider allowing reimbursements for this procedure that affords a remarkable alternative that proven to be safe.  Thank you, Nir J. Hus,  MD, PhD, FACS. Trauma Surgery,General Surgery,Acute Care Surgery,Trauma  Surgical Critical CareDelray Medical Center, Delray FL. Assistant Professor of Surgery School of Medicine, Florida Atlantic University, FLDrNirHus@gmail.com I  want to comment on the opioid crisis that is plaguing our society with false propaganda about overdoses. I am a disabled retired Electronics Technician at 63 years old and worked at it for years and carried heavy equipment practically each time I had a job to do which included near at least 40 pounds of test equipment.  My body aches from head to toe. I have a condition of my neck since 1987 called Cervical Spondylosis and had to work through the pain until about 2006 until my body could not take it anymore. During the late 1990s to the turn of the century I was diagnosed with Lumbar Spondylitiis after I fell on my tailbone and it would not heal. About the turn of the century I worked for a wireless corporation and was sent on simple jobs such as just walking through the New Orleans Convention Center with a small phone when my back gave out and it was either call 911 or find an empty corridor in which I could lie down which I did to recover enough to get home to take my pain pills and muscle relaxer (Soma) winch helped so much and now cannot get a prescription for.them... THANK YOU FOR THAT!  Since the turn of the century, Ive had 2 right breast surgeries, a torn meniscus surgery in which Im about to have on my other knee. An abdominal hernia surgery and a Total Knee Replacement Surgery with another knee in the wake of the same fate. Now I am racked with pain of arthritis and just because other people do not have or have been lucky enough not to feel this pain, want to ban pain medications because someone overdoses, they feel they must take everything off of the shelves. I know a few addicts and believe me, they just dont OD from prescription drugs. They like to add Heroin, Xanax, Soma when it was available, benzodyazapines, cocaine and Meth and I dont mean one at a time either. They will take as much as they want with no regard to what may happen. I also think the government wants to blame the pharmaceutical industry, doctors and pharmacies for their overdoses. I think this is propaganda to throw people off because the real problem is in the streets and the DEA and other Federal agents want to throw the attention on something they can control instead of kingpins such as Pablo Escabar or El Chapo who someone will step in there shoes when they are gone. So they (The Feds) can control the FDA and regulate what drugs we take instead of going after the big fish to keep their election going. So go ahead and take away our pain meds so we can just lie in bed all day suffering hoping we will die soon to get some form of relief. Also if you do take pain meds off of the shelves, have you thought what legitimate pain sufferers might do to get relief. Probably go to the streets. Now do you want to make a junkie out of a legitimate pain sufferer? Think about it.  THANK YOU FOR LETTING ME BLOW OFF A LITTLE STEAM BUT IT IS TRUE! As a thoracic surgeon, I see the impact chest pain has on patients with rib fractures and chest surgery. Patients can have debilitating pain for weeks. The typical treatments of pain like this are narcotics, but studies suggest that patients who take narcotics for more than 6 weeks are at higher risk of taking narcotics for months. Regional anesthesia can be used to provide relief for these patients. Exclusion of regional anesthesia from the global billing period is a significant disincentive to utilization of these techniques. I believe that this exclusion has a perverse effect of increasing long term narcotic use, which is fast becoming a national health emergency. Please consider excluding regional anesthesia from the global billing period. My 23 year old pain is insane! I have massive rods and metal holding my back together and in 24 unbearable pain constantly and with new restictions I cant even get out of bed!  The National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM)  commends the Pain Management Best Practices Inter-Agency Task Force for its final report for non-opioid, best-practice options to manage acute pain. The NCCAOM appreciates the Task Forces commitment to addressing the countrys pain and opioid crisis by recognizing and supporting non-pharmacological pain-management options.  The NCCAOM seeks to ensure the publics safety and well-being by establishing and promoting national, evidence-supported competence and credentialing standards for the acupuncture profession. Each year, the NCCAOM certifies 1,200 -1,500 acupuncturists and represents almost 18,000 nationally board-certified acupuncturists. In recent years, the NCCAOM has advocated for acupuncture services as a supplement to, or replacement for, opioid prescriptions for chronic and acute-pain complaints. The NCCAOM applauds the final reports multimodal approach that includes medications, nerve blocks, physical therapy, and other modalities such as acupuncture for managing acute pain.  The NCCAOM also appreciates the final reports biopsychosocial care models to promote a multidisciplinary approach to treating chronic pain. The NCCAOM specifically supports the Task Forces following initiatives: Section 2.1  Approaches to Pain Management:  Encourage coordinated and collaborative care that allows for best practices and improved patient outcomes whenever possible, using the Veterans Administrations (VA) and the Department of Defenses (DOD) collaborative, stepped, pain-care model.Section 2.6  Complementary and Integrative Health: Grow the evidence base to standardize and implement complementary and integrative pain-management options.  Section 3.3  Education: Educate patients and practitioners about recommended non-opioid, non-pharmacological treatment options to make them aware of the available, personalized treatment options.Section 3.4.2  Insurance Coverage for Complex Management Situations: Recognize and address the barriers that inadequate reimbursement presents to facilitate payment models that recognize and reimburse holistic, integrated, multimodal pain management. Section 3.4.3  Workforce:  Increase the pain-specialist workforce such as certified acupuncturists and create incentives for multidisciplinary pain-management teams and programs of excellence to treat diverse and complex pain conditions. oThe NCCAOM strongly recommends that efforts to integrate practitioners into the healthcare delivery system should ensure these clinicians meet appropriate training requirements. oThe Final Report highlights the VAs efforts to provide collaborative, integrative pain care to its beneficiaries. In doing so, the VA has expanded access to acupuncture for all covered veterans, and help ensure patient safety and quality by requiring NCCAOM board certification for all of its acupuncturists. This standard helps ensure that all practitioners are qualified to provide reliable, high-quality care to patients. Other entities should use the VA model to develop appropriate workforce requirements for pain- management practitioners. The NCCAOM thanks the Task Force for prioritizing efforts to improve pain management across the country, and looks forward to continuing to support efforts in the acupuncture environment. The NCCAOM stands by as a resource and partner combatting opioid misuse, overuse, dependency. Please contact Molly Giammarco, Senior Manager, Government Relations for the NCCAOM, with any questions.  Vanila M. Singh, M.D., MACMChief Medical Officer, Chair, Pain Management Task Force, Office of the Assistant Secretary for Health and Human ServicesDr. Singh and Honorable Members of the Task-Force,Thank you for the opportunity to comment on the upcoming meeting between the Pain Management Best Practices Inter-Agency Task Force and the Health and Human Services (HHS) department.  We are looking forward to the discussion on payment and coverage policies for chronic and acute pain, service delivery models, access to therapies and medical devices, and other issues outlined in section 6032 of the SUPPORT Act.Our comments in this letter will focus on the potential clinical benefit with medical devices used during open cardiac and thoracic surgery (with acute pain associated with a thoracic intervention) and the lack of coverage and incremental payment options available for providers for non-opioid pain management modalities.Cardiac and Thoracic Surgical Procedures: Medical Device SolutionsThere are over 500,000 cardiac and thoracic (CT) surgical procedures annually.  According to the Society Thoracic Surgeons (STS), 1 in 7 (~14%) of patients undergoing CT surgery are at increased risk for long term opioid addiction (~70,000 annually).  In May 2018, then FDA Commissioner Scott Gottlieb testified before Congress on the agencys approach to this crisis, There are also a lot of medical device alternatives and we have approved over 200 different ones that help treat pain.  Non-opioid medical device strategies for managing pain have the potential to make a significant impact for this important clinical problem.  One such treatment available is cryothermic nerve ablation, which is a procedure that freezes peripheral nerve endings near the site of surgical incision to temporarily block the transmission of pain signals to the brain after surgery.  Currently, there is a FDA 510K-cleared medical device available for cryoablation (the AtriCure cryoICE and cryoSPHERE probe). This technique can be used with a variety of cardiac and thoracic surgical procedures, such as heart valve replacement, coronary artery bypass, pneumonectomy, thoracoabdominal interventions, lung transplants, thoracic trauma, and pectus repair.  The procedure adds 10-15 minutes to the total surgical procedure time.  The ablated nerve endings grow back over 30-60 days post-surgery, and during this time pain sensation near the incision site may decrease, and the need for opioid use is potentially decreased. (See studies referenced below).However, incremental payment for the hospital for adding cryoablation to the existing cardiac/thoracic procedure does not exist. The current CMS payment mechanism does not allow incremental payment for this procedure. We specifically would like HHS/CMS to consider the following:1.Cryoablation for nerve block during surgery, for the specific treatment of post-operative pain management is considered a second adjunctive procedure, and under the current CMS inpatient payment system, only one MS-DRG is allowed payment during the patient inpatient stay2.Cryoablation for nerve block during surgery, for the specific treatment of post-operative pain management has been available for a number of years, and is not eligible to meet CMS New Technology Add-on (NTAP) criteria3.The lack of additional hospital reimbursement for cryoablation for nerve block during surgery, for the specific treatment of post-operative pain management has limited patient access for opioid sparing procdures4.We ask HHS/CMS to consider alternative payment options for opioid sparing medical devices that are used adjunctively during surgery for the specific purpose of post-operative pain management; e.g. incentive payments, CMMI quality programs, add-on payments, etc.We thank HHS for considering medical devices as one part of the solution in the opioid epidemic.  We are available to discuss this important topic further and look forward to working with HHS and CMS to advance best care for patients.Sincerely,Michael Ferguson, PhDVice President, Healthcare Economics and ReimbursementAtriCureReferencesGraves. C.E., et al. Intraoperative intercostal nerve cryoablation during the Nuss procedure reduces length of stay and opioid requirement: a randomized clinical trial. Journal of Pediatric Surgery in press, (2019).Harbaugh, C.M., et al. (2018). Comparing outcomes with thoracic epidural and intercostal nerve cryoablation after Nuss procedure. J Surg Res, 231: 21723.Kim, S., Idowu, O., Palmer, B., Less, S.H. (2016). Use of transthoracic cryoanalgesia during the Nuss procedure. J Thorac Cardiovasc Surg,151(3): 8878.Keller, B.A., et al. (2016). Intercostal nerve cryoablation versus thoracic epidural catheters for postoperative analgesia following pectus excavatum repair: preliminary outcomes in twenty-six cryoablation patients. J Pediatr Surg, 51(12): 20338. CMS opioid prescribing guidelines neglected to exclude Sickle Cell Disease (SCD) from the guidelines. The result was unnecessary suffering by patients affected by SCD. Physicians used these guidelines and under treated the severe pain associated with SCD. CMS therefore had to later clarify these guidelines. It is my hope that this error is not repeated. Prior to the opioid crisis patients living with SCD were already struggling with receiving adequate and timely acute and chronic pain control. This experience has escalated due to the current environment. I speak as a retired physician who cared for patients with SCD and an individual living with SCD. It is essential to practice safe and effective pain management for individuals who have acute and chronic pain. Pain can have a significant effect on someone and cause them to have multiple health related diseases. It can affect the way you sleep, eating right, and exercising. It can also change your mood and work and can keep you from spending time with your friends and family (ASOA, 2018). Opioids are beneficial to someone for acute pain to help manage it, especially after surgeries or a broken bone. Opioids are not safe to be on every day because they can cause respiratory depression and very addictive. This is why it is important for people who have chronic pain to find alternative ways that work for an individual, so they dont have to deal with chronic pain for the rest of their life. This also should be covered with insurance since the individual cant help it. Many alternatives can be used. For examples like Acetaminophen, Ibuprofen, Naproxen, exercise, physical/massage therapy, counseling, acupuncture, cryotherapy, steroid injections, radiofrequency ablation, neuromodulation, and possibly anti-seizure medication. Doctors should help their patients find a specific treatment that works for their patient and help get them to get it covered with insurance. Medicare and Medicaid should include these treatments in coverage for individuals so they dont have many other health problems related to chronic pain, which will cost more money in a long way. Pain management is an important topic that should be discussed and continued to be managed for individuals.