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Medical Necessity Desired David Collipp, M.D. NewSouth NeuroSpine (NS)2 MASI Conference Thursday February 26, 2015 Embassy Suites, Ridgeland, MS Overview When to order imaging? When to use opiates? Who needs injections? Who needs surgery? Therapies? Modalities? DME? RTW? Bone and Joint Decade Taskforce as an initiative of the U.N. and the WHO with publications in Spine and Spine Journal in 2008. This Task Force included literature review from 1980-2006 with 31,878 citations. This study included evaluation of epidemiology, risk factors (modifiable and nonmodifiable), outcomes and treatments. IMAGING Increasing Use of Imaging for Low Back Pain 307% increase in 12 years Deyo RA et al. J Am Board Fam Med 2009; 22: 62-8 Prevalence: Specific Diagnoses Rough estimates from primary care: Compression fracture 4% (or less) Spondylolisthesis 3% Malignant neoplasm 0.7% (or less) Ankylosing spondylitis 0.3% Spinal infection 0.1% Spinal Stenosis ?? Surgically important disc herniation Total Specific Diagnoses: ~10% 2% “Normal” MRI Results in 67 Subjects Age Under 60 Over 60 Herniated disc 22% 36% Spinal Stenosis 1% 21% Bulging disc 54% 79% Degenerated disc 46% 93% Boden et al, JBJS, 1990 Imaging Hazards A diagnosis based on MRI, in the absence of objective clinical findings, may not be the cause of a patient’s pain, and an attempt at operative correction could be the first step toward disaster. Boden et al, JBJS, 1990 Impact of Imaging on Outcomes: Testing a Diagnostic Test 6 RCTs, 1804 patients, no red flags 4 trials plain x-ray, 2 of MR or CT No advantage of imaging in short or long term (up to 1 year) for: -pain -mental health -function -satisfaction with care -quality of life Results not affected by trial quality, imaging modality, duration of LBP Chou R, Fu R, Carrino JA, Deyo RA. Lancet 2009; 373: 463 Could imaging do harm? 2 RCTs 1. British RCT: 421 pts, >6 weeks of LBP After 3 months, those who received x-rays: -had worse pain -lower overall self-reported health -but…were more satisfied with care 2. 246 pts with lumbar MR, randomized to receive results or not Self-rated general health improved significantly more in patients who were blind to the MR results. Kendrick D, et al. BMJ 2001; 322: 400 Ash LM et al. Am J Neuroradiol 2008; 29: 10981103 “Cascade Effects” of early lumbar MRI? 1. Workers Comp, n=3,264, 22% early MRI Low-risk patients who received MRI were several times more likely to receive injections, and surgery. These were more associated with early MR than clinical severity or demographic indicators. Webster BS et al. J Occup Env Med 2010; 52: 900 2. 380 pts randomized to plain x-ray vs. MRI 2.5x more surgery in MR group (p=.09) Equivalent pain & function at 1 year MR group more reassured Jarvik J, Deyo R et al. JAMA 2003; 289: 2810 2007 and 2011 ACP/APS Back Pain Guidelines No routine imaging, dx tests for non-specific LBP. Image if major Ca risks; progressive neuro deficit, cauda equina, new fever or injection drug use. Image after Rx trial if risks for comp fx, ankylosing spondy, stenosis, or minor risks for Cancer. No discography Chou R et al. Ann Intern Med 2007; 147: 478. Chou R et al. Ann Intern Med 2011; 154: 181. The Doctor’s Dilemma: How to be patientcentered and evidence-based. Physicians are often concerned about patient satisfaction and medicolegal risks. Strong pressure contrary to evidence; pts seek mechanical explanations. Labeling, costs, cascade effects don’t resonate. Survey: 36% of physicians would order MR for 1st episode of acute LBP (2 days) that began in work around house if pt. insistent, even after explaining test unnecessary. Campbell. Ann Intern Med 2007; 147: 795 Addressing patient demand? Satisfaction ≠ better health--implications for performance measures. Redouble patient education--some evidence that satisfaction can be maintained. Imaging itself teaches patients what to expect--in one RCT obtaining x-rays raised the expectation they should always be done. Quality of care is defined in part by avoiding overuse— physicians must teach that more is not always better. Deyo RA et al. Arch Intern Med 1987; 147: 141-45 Treatment Gotta Start Somewhere Opioids Diagnosis -Soft Tissue (first 48-72 hours) -Neurologic (role) -Orthopedic (1 week to 3 months) Timing -acute v chronic Precautions -drug interactions -medical conditions -addiction -diversion -impact on function Tool -History and Physical -Phone -https://rpt.pmp.relayhealth.com/MS -Old records -UDS Opioids From 1997 to 2004 there was a 556% increase in sales of Oxycodone, a 500% increase in therapeutic grams of Oxycodone used, and a 568% increase in the non-medical use of sustained-release Oxycodone, a 229% increase in opioid-related deaths (without heroin or cocaine) an increase from 1942 (1999) to 4451 (2002) deaths. Drug Enforcement Agency (DEA) Automated Reports and Consolidated Orders System Increase in Expenditures, 1997-2006: 660% Due to both volume and price $246 Million $1.9 Billion Martin BI, Deyo RA et al. Spine 2009; 34: 2077 Opioids Retail sales noted an increase from 1997 to 2007 in Methadone (1293%), Oxycodone (866%), Fentanyl (525%), hydromorphone (319%), and morphine (222%). Average per person sale increased from 1997 (74mg) to 2007 (369mg). The U.S. has 4.6% of the world’s population and consumes about 80% of the world’s opioid supply, and 99% of the hydrocodone, as well as 2/3’s of the world’s illegal drugs. Manchikanti L, et al., Therapeutic use, abuse and nonmedical use of opioids: A ten-year perspective, Pain Physician, 2010; 13(5):401-35. Opioids Opioid misuse in workers’ compensation settings has been linked to death, and higher rates of misuse are noted in unemployed patients. Epidemiological Trends in Abuse and Misuse of Prescriptions Opioids. Spiller, H, et. al., 2009, J Addict Dis, Vol. 28, pp. 130-36 Opioids Long Term Opiate Use for Chronic, Non-malignant Pain. -Inadequate Pain Relief -Poorer quality of Life -Long-term unemployment -High levels of medical care seeking Eriksen J, et al., Critical issues on opioids in chronic non-malignant pain: An epidemiological study, Pain, 2006; 125:172-9 Opioids Reduce likelihood of recovery from chronic pain (4x) Higher risk of death 1.67:1 Poor pain relief (mean 32% in about 40% of patients) Poor quality of life Unimproved functional capacity 52.1% had recovery from Chronic Intractable Pain (not from opioids). Sjøgren P, et al., A population-based cohort study on chronic pain: The role of opioids, Clinical Journal of Pain, 2010;26(9):763-9 Opioids Individuals with high-dose opioid therapy after workrelated injuries had poorer outcomes in terms of RTW, work retention, medical utilization and long-term disability status compared with those who did not opt for opioids. Kidner CL, et al., Higher opioid doses predict poorer functional outcome in patients with chronic disabling occupational musculoskeletal disorders, JBJS (Am), 2009;91(4):919-27 Opioids VA Pts receiving high-dose opioids reported higher pain levels (on meds) than patients receiving lower doses. Danish population survey: chronic pain patients using opioids reported lower Quality of life (SF-36), more severe pain than those not receiving opioids. Morasco B,…Deyo RA, et al. Pain 2010; 151: 625. Eriksen J, et al. Pain 2006; 125: 172. Opioid prescribing for low back pain Useful for severe acute pain; time-limited use or nighttime use with NSAIDs during day. Generally switch within 2 weeks of use; prepare patient. Avoid >100mg/day morphine equivalents. Avoid co-prescriptions of BZDs and Soma with opiates. Long-term use: screen carefully for hx of substance abuse, mental illness, depression; informed consent . APS Guide: option for severe disabling LBP; carefully consider risk:benefit; consider alternatives if no response to short course. Focus on Function. Injections Efficacy of Epidural Steroid and Facet Injections? For sciatica, mixed study results: ½ suggest modest benefit, ½ suggest no benefit. Axial back pain: no evidence of benefit. (58% of injections not for radiculopathy or HNP.) No reduction in surgery rate in 2 RCT’s; surgery rates highest where injection rates highest. Facet injections: RCT’s consistently neg. Overall: modest sciatica symptom relief from epidurals, no change in outcomes. Suggestions regarding injections APS and Am Acad. Neurol. Guidelines: Epidural steroids for temporary pain relief of persistent lumbar radiculopathy. AAN: ESI--No effect on functional impairment, need for surgery, or pain relief beyond 3 mos; routine use for these reasons not recommended. Avoid epidurals for back pain; avoid facet joint injections. Insufficient evidence for spinal stenosis. Trigger Point Injections Not recommended in Chronic Low Back Pain. May help in acute LBP when all other conservative measures have failed. “Evidence-informed management of chronic low back pain with trigger point injections” Malanga G, et al., Spine Journal, Jan 2008 (8), issue 1, 243-252 Surgery Indications for Spine Surgery Cauda Equina syndrome: bilateral leg weakness, difficulty walking, bowel or bladder dysfunction (usually urinary retention). Progressive neurologic deficit. Certain cases of fracture, tumor, and infection. Elective surgery Patient with herniated disc, stenosis or spondylolisthesis with back and leg pain. Poor response to conservative Rx. Hx, exam, imaging all consistent. Patient understands benefits, risks, of both surgery and non-operative care. Back pain alone? Some controversy. Neurological Recovery in RCT for Herniated Disc (N=64 w/Paresis) 4 yr: Total recovery dorsiflexion Total recovery plantar flexion 10 yr: Recovery all weakness No Surgery Surgery 44% 43% 56% 75% 84% 84% Weber H. Spine 1983; 8: 131 HNP: Surgery v Non-surgery Non-surgical Surgical Peul WC et al. N Engl J Med 2007; 356:J2245 Peul WC et al. N Engl Med 2007; 356: 2245 Surgical Outcomes “This systematic review of the literature revealed that patients treated under compensation schemes or undergoing litigation consistently have worse outcomes after surgery than non-compensated patients. Of the 211 studies reviewed, 175 reported a worse outcome in compensated patients. Overall, compensated patients have more than 3 times the odds of an unsatisfactory outcome compared with noncompensated patients.” Harris, Mulford, Solomon, Gelder & Young, JAMA, April 6, 2005-Vol 293, No. 13, “Association Between Compensation Status and Outcome After Surgery” Physical therapy and friends Physical Therapy Exercise is a proven treatment for back and neck pain from injury and degenerative disease. Sedentary overweight and obese adults can be advised to initiate and maintain an exercise program. Only 7% had injury attributable to exercise alone. Janney CA and Jakicic JM, The influence of exercise ad MBI on injuries and illnesses in overweight and obese individuals: a RCT, International Journal of Behavioral Nutrition and Physical Activity; Jan 6, 2010 Physical Therapy Exercise and supervised exercise includes aggressive stretching and strengthening work. Therapy for targeted muscles or muscle groups and can include flexion or extension bias based upon patient’s clinical findings. PT causes muscular discomfort during and after the exercises, particularly with some delayed onset muscle soreness. Physical Therapy There is no evidence that any particular form of exercise (walking, running, swimming, yoga, Pilates) is superior to the resumption of normal activity in acute back pain. Hendrick P, et al., The effectiveness of walking as an intervention for low back pain: a systematic review, European Spine Journal, 2010 Traction 300 pounds of manual traction results in a 1cm cumulative interspace distance increase. Cyriax JH. Textbook of Orthopedic medicine: diagnosis of soft tissue lesions. 8th Ed. London: alliere Tindall, 1982 Patient selection best limited to DJD/DDD and disc herniations with mechanical root irritation. Gains should be greater than 2mm. Modalities Heat Ice Short-wave Diathermy TENS Ultrasound No Evidence for use in Chronic Low Back Pain. Use as adjunct to tolerate therapy in acute injury accepted. “Evidence-informed management of chronic low back pain with transcutaneous electrical nerve stimulation, interferential current, electrical muscle stimulation, ultrasound, and thermotherapy.” Poitras S, Brusseau L, Spine Journal, Jan 2008; (8)issue 1, 226-33 TENS Short-term use has documented benefit, but long-term use has no statistical benefit. “Evidence-informed management of chronic low back pain with transcutaneous electrical nerve stimulation, interferential current, electrical muscle stimulation, ultrasound, and thermotherapy.” Poitras S, Brusseau L, Spine Journal, Jan 2008; (8)issue 1, 226-33 Cognitive Behavioral Therapy Helpful for acute and chronic LBP, and recommended to be used with a multidisciplinary approach. “Evidence-informed management of chronic low back pain with cognitive behavioral therapy” Gatchel R, et al., Spine Journal, Jan 2008 (8), issue 1, 40-44 Back school, Brief Education, Fear-avoidance training. Brief Education is superior to CBT for moderate kinesiophobia and pain, and current recommendations are to have brief education as part of a PT program. “Evidence-informed management of chronic low back pain with back schools, brief education, and fearavoidance training” Brox, JI, et al., Spine Journal Jan 2008 (8), issue 1, 2839 Massage Recommended effective for chronic LBP, and acupressure may be better than massage. “Evidence-informed management of chronic low back pain with massage” Imamura M. et al., Spine Journal, Jan 2008 (8), issue 1, 121-133 Acupuncture Not recommended for acute or chronic LBP. Poor studies overall, and very short term relief. “Evidence-informed management of chronic low back pain with needle acupuncture” Ammendolia C, et al., Spine Journal Jan 2008 (8), issue 1, 160-172 Home exercise program, Smoking cessation, Weight loss. HEP has moderate evidence to be helpful for CLBP, whereas smoking cessation and weight loss are of no statistical benefit. “Evidence-informed management of chronic low back pain with physical activity, smoking cessation, and weight loss” Wai, EK, et al., Spine Journal, Jan 2008 (8), issue 1, 195-202 Spinal Manipulative Therapy (SMT) Mobilization SMT and mobilization at least equal to PT for outcomes in acute and chronic LBP. “Evidence-informed management of chronic low back pain with spinal manipulation and mobilization” Bronfort, G, et al., Spine Journal Jan 2008 (8), issue 1, 213-225 DME Assistive devices (e.g. Canes, walkers, hemiwalkers, quad canes, Lofstrand crutches, etc.) and orthotics (e.g. TLSO, LSO, Chairback etc.) should be avoided unless being prescribed for some other condition or neurologic damage related to the spine injury. Increase injury possibility, and decrease prescribed treatment effectiveness. Return to work Return to Work Canadian Medical Association Policy Summary “The Physician’s Role in Helping Patients Return to Work After Illness or Injury” CMAJ 1997; 156 (5): 6, 80 A-F “Prolonged absence from one’s normal roles, including absence from the workplace, is detrimental to a person’s mental, physical, and social well being. Physicians should therefore encourage a patient’s return to function and work as soon as possible.” RTW 2000 Ontario, Canada Workplace Safety and Insurance Board (WSIB) http://www.wsib.on.ca/wsi b/wsibsite.nsf/LookupFiles /DownloadableFilePhysicia nsRTWGuide/$File/RTWG P.pdf “Prolonged absence from one’s normal role is detrimental to physical, mental, and social well being. Long term unemployment postinjury is itself a health problem.” RTW August 2004 UK Department of Work and Pensions Medical evidence for Statutory Sick Pay. Statutory Maternity Pay and Social Security Incapacity Benefit purposes. A Guide for Registered Medical Practitioners. http://www.dwp.gov.uk/medica l/medicalib204/ib204june04/ib204.pdf “As a certifying doctor you will need to consider and manage your patient’s expectations in relation to their ability to continue working. In summary, you should always bear in mind that a patient may not be well served in the longer term by medical advice to refrain from work, if more appropriate clinical management would allow them to stay in work or return to work.” RTW AMA Policy and Directives 2004 Adopted June 2004 http://www.amaassn.org/ama/pub/article/print/20 36-8668.html assessed 06/26/04 2. The AMA encourages physicians everywhere to advise their patients to return to work at the earliest date compatible with health and safety and recognizes that physicians can, through their care, facilitate patients’ return to work. (Policy) RTW Joint statement by: Faculty of Occupational Medicine Royal College of General Practitioners Society of Occupational Medicine UK 2005 http://www.facoccmed.ac.uk/libra ry/docs/conf_haw.pdf “ ‘Worklessness’ (being unemployed or economically inactive and in receipt of working age benefits) causes poor health and health inequality, and this effect is still seen after adjustment for social class, poverty, age, and pre-existing morbidity.” RTW Joint statement by: Faculty of Occupational Medicine Royal College of General Practitioners Society of Occupational Medicine UK 2005 http://www.facoccmed.ac.uk/libra ry/docs/conf_haw.pdf -“People who are out of work experience poorer mental health …” -“Anxiety and depression are two to three times more common …” -“Being out of work can lead to increased smoking, consumption of alcohol, use of illicit drugs, and risk taking sexual behavior.” -“… worklessness leads to increased mortality rates.” RTW Joint statement by: Faculty of Occupational Medicine Royal College of General Practitioners Society of Occupational Medicine UK 2005 http://www.facoccmed.ac.uk/libra ry/docs/conf_haw.pdf “The negative effects of unemployment are reversible on re-entry to work.” RTW Unemployment is detrimental to your health. The health consequences of unemployment: the evidence. Mathers, Schofield, Med J Aust 1998; 168 (4): 178-182 “…longitudinal studies with a range of designs provide reasonably good evidence that unemployment itself is detrimental to health and has an impact on health outcomes – increasing mortality rates, causing physical and mental ill-health, and greater use of health services.” RTW “Effects of unemployment on mortality were more pronounced with increasing duration of unemployment.” “Conclusion: The relative excess mortality of unemployed men in Finland cannot be explained by demographic, social, and health variables preceding unemployment. Unemployment therefore seems to have an independent causal effect on male mortality.” Unemployment and Mortality among Finnish men 1981-85, Martikainen P, BMJ 1990; 301 Sep: 407-411 Controlled for background variables affecting mortality. Total Mortality: unemployed have a (relative risk) RR of 1.93 (95% CI = 1.82-2.05) Accidental and violent death: RR 2.51 (2.28-2.76) Circulatory Diseases: RR 1.54 (1.40-1.70) RTW -Men with unemployment or early retirement 2x more likely to die in the next 5.5 years (BMJ 1994) -Unemployment independently related to mortality (Scand J Prim Health Care 1996) -Unemployed have increased mortality ratio (Lancet 1996) -Unemployed have 25% increased cancer mortality (IARC Sci Publ 1997) -Unemployment related to psychiatric symptoms and death (Scand J Work Environ Health 1997) -Increased cardiovascular mortality in US, UK and Scand (Acta Physiol Scand 1997) -Unemployment significantly related to suicide (J Stud Alcoh0l 1998) -Premature mortality (Am J Public Health 1999) -Related to Mortality (Occup Environ Med 2001 {Twin Study}) -Increased death risk by 50% (J Health Economics 2003) -Increased CVA and MI (Am J Ind Med 2004) Conclusions MRI for radicular findings or trauma that could cause fracture/tear. Or 1 month of failed conservative management (new diagnosis?). Report degenerative changes as such. Minimal Narcotics and brief use. ESI for radiculopathy, avoid most facet joint injections. Judicious use of Trigger Point injections. Rarely surgical; most surgery truly elective. Conclusions Avoid excessive modalities (adjunctive). Avoid Acupuncture (pending research). Avoid canes, walkers, bracing etc. Avoid focusing on weight loss and smoking cessation. Avoid HEP as stand-alone treatment. Conclusions Use minimal narcotics, carefully, briefly. Use therapy to increase activity level, noting it will be uncomfortable in both acute and chronic patients. Use brief Education-especially during treatment. May use Cognitive Behavioral Therapy. May use Traction for mechanical compression and DJD. Use NSAIDs. May use Mobilization and Manipulation. May use TENS (short term). May use Massage/MFR for CLBP. Conclusions Keep your patients at work as much as possible. The End: Thank You 65 Thank You