MEDICAL TREATMENT PARAMETERS Molly N. Tyroler I. INTRODUCTION These materials provide an overview of both general and specific treatment parameters and include information concerning the formation of the parameters, dates of applicability, purpose, application to treatment requests, and recommendations on how to handle requests. The materials also include information about the more controversial and often litigated parameters. II. HISTORICAL BACKGROUND An action plan published in 1991 by the Department of Labor and Industry first addressed managing the consumption of medical services and cost associated with each service by implementation of parameters to control medical costs within the workers’ compensation system. Emergency and permanent rules were established in 1993 for the purposes of determining “whether a provider of health care services . . . is performing procedures or providing services at a level or with a frequency that is excessive, unnecessary, or inappropriate based upon accepted medical standards for quality health care and accepted rehabilitation standards.” Hirsch v. Bartley-Lindsay Co., 537 N.W.2d 480, 483 (Minn.1995). The emergency rules were immediately challenged, and, in Hirsch, invalidated by the Minnesota Supreme Court. As a result, the Commissioner revised the rules and issued the Permanent Treatment Parameters, which went into effect in 1995. These treatment parameters were also challenged, but the Minnesota Supreme Court concluded that the revised rules did not conflict with the enabling Minnesota state statute and that the Department of Labor and Industry did not exceed its authority in promulgating the parameters. Jacka v. Coca-Cola Bottling Company, 580 N.W.2d 27, 34 (Minn. 1998). III. PERMANENT PARAMETERS The workers' compensation treatment parameters can be found in Minnesota Rules Parts 5221.6010 through 5221.6600. These rules have been adopted under Minnesota Statutes 176.83 and 176.103. The specific treatment parameters are: 5221.6010 Authority 5221.6020 Purpose and Scope 5221.6030 Incorporation by Reference 5221.6040 Definitions 5221.6050 General Treatment Parameters 5221.6100 Parameters for Medical Imaging 5221.6105 Medications 5221.6200 5221.6205 5221.6210 5221.6300 5221.6305 5221.6400 5221.6500 5221.6600 Low Back Pain Neck Pain Thoracic Back Pain Upper Extremity Disorders Reflex Sympathetic Dystrophy of the Upper and Lower Extremity Inpatient Hospitalization Parameters Parameters for Surgical Procedures Chronic Management A. Applicability The treatment parameters apply to all dates of injury and health care providers; however they apply only to treatment that was provided after January 4, 1995. Minn. Rule 5221.6020, Subp. 2. The Treatment Parameters do not apply where the employer or insurer have denied primary liability. Similarly, the Treatment Parameters do not apply to treatment provided after the date of denial if the insurer initially admits liability, but later denies liability alleging the employee suffered a temporary aggravation that had resolved. Oldenburg v. Phillips & Temro Corporation, 60 W.C.D. 8 (1999), summarily aff’d, 606 N.W.2d 445 (Minn. 2000). Bryant v. Honeywell, Inc., slip op. W.C.C.A. April 25, 2003). Practice Tip: Even if the Treatment Parameters do not apply, you may still use the Treatment Parameters as guidance when analyzing whether the medical treatment before you is reasonable and necessary. B. Purpose The purpose of the rules, as outlined in Minn. Rule 5221.6020, Subp. 1., is to establish guidelines for reasonable and medically necessary treatment of employees with compensable workers’ compensation injuries. The parameters are intended to prevent excessive services, Minn. Stat. §176.135 and §176.136. The parameters were designed to assist in the determination of whether services are performed at a level or with a frequency that is “excessive, unnecessary or inappropriate.” Jacka v. Coca-Cola Bottling Company, 580 N.W.2d 27, 34 (Minn. 1998). Based on the treatment parameters, the insurer may deny payment for excessive services. C. General Guidelines The general parameters, as defined in Minn. Rule 5221.6050, include broad guidelines that apply to all work-related injuries. These include (1) medically necessary and effective treatment, (2) departure from the guidelines, and (3) procedural and notice requirements. 2 1. Medically Necessary and Effective Treatment Under the general parameters, “all treatment must be medically necessary treatment.” Minn. Rule 5221.6050, Subp. 1. A. Minn. Rule 5221.6050 states that the provider must evaluate whether nonsurgical treatment is “effective.” To be effective, the parameters require treatment results in two of the following three improvements: (1) improvement of “subjective complaints of pain or disability,” (2) improvement in objective clinical findings, and (3) improvement in functional status, “especially vocational activities.” Minn. Rule 5221.6050, Subp. 1. B. If the above results are not met, “the modality must be discontinued or significantly modified, or the provider must reconsider the diagnosis.” Id. Further, the health care provider is required by the parameters to use the “least intensive setting appropriate and must assist the employee in becoming independent in the employee's own care to the extent possible so that prolonged or repeated use of health care providers and medical facilities is minimized.” Minn. Rule 5221.6050, Subp. 1. C. 2. Departure From the Guidelines With regard to duration of treatment, the general Treatment Parameters allow for departure from a parameter. Parameters are to be used by compensation judges as a “flexible guide to determine what treatment is reasonable according to medical standards.” Jacka gave compensation judges room to depart from the rules “in those rare cases in which departure is necessary to obtain proper treatment.” Jacka, 35-36. Jacka is important to remember when analyzing whether treatment is reasonable or necessary. Departures are regularly, not “rarely,” granted by compensation judges. There have been several decisions by the Workers’ Compensation Court of Appeals that have exemplified their desire to expand the “rare case” rule set out in Jacka. For example, in one case, the Workers’ Compensation Court of Appeals affirmed a compensation judge’s departure from the treatment parameters and permitted chiropractic treatment for a period of years after the expiration of the twelve-week passive care rules, even though the chiropractor’s records were “not so detailed as we might have wished” and the evidence supporting departure was only “minimally adequate.” Boisijoli v. Lyndale Garden Center, slip op. (W.C.C.A. April 20, 1999). As defined in Minn. R. 5221.6050 Subp. 8, departure may be appropriate in any one of the following circumstances: Where there is a documented medical complication (see case below for definition of “complication”); Where previous treatment did not meet the accepted standard of practice and the requirements of the health care provider who ordered the treatment; 3 Where treatment is necessary to assist the employee in the initial return to work where the employee's work activities place stress on the part of the body affected by the work injury; Where treatment continues to meet two of the following criteria, as documented by medical records: 1. the employee's subjective complaints of pain are improving, 2. the employee's objective complaints are improving, 3. the employee's functional status, especially vocational activity, is objectively improving; Where there is an incapacitating exacerbation of the employee's condition. As noted above, the rules allow for departure from the Treatment Parameters if there is a “documented medical complication.” A “complication” has been defined as “a disease or diseases concurrent with another disease,” and as “the concurrence of two or more diseases in the same patient.” A medical complication within the rule includes situations where the work injury, in combination with a pre-existing condition, causes a more complicated course of symptoms, disability, and treatment results. Jackson v. Minneapolis Public Sch. Special Dist. #1, slip op. (W.C.C.A. April 8, 2010). In 1999, the Minnesota Supreme Court explained and then expanded their previous “rare case” rule. Asti v. Northwest Airlines, 588 N.W.2d 737 (Minn. 1999). In Asti, the Workers Compensation Court of Appeals held that there was no evidence that would support the conclusion that the recommended treatment could qualify as “assisting the employee in his initial return to work,” and, therefore, this situation was not a ‘rare case’ as specified in Jacka. at 739. While the Supreme Court agreed that there was no evidence of “progression in activities” allowing for an additional period of treatment under Minn. R. 5221.6600, subp. 2B (3), and noted that the employee “failed to meet the specific requirements of departure,” they reversed the holding of the WCCA. In justification of the reversal, the Court stated, “It cannot be legitimately asserted that the drafters of the treatment parameter rules considered every possible scenario . . . .” Thus, this case was one of the “rare” cases where a departure was necessary. 3. Procedural Requirements It is the healthcare provider’s responsibility to notify the insurer of the proposed treatment in writing or orally at least seven working days before the treatment is initiated. Minn. R. 5221.6050, Subp. 9. A-B. It is then the insurer’s responsibility to respond to the proposed treatment within seven days of notification of proposed treatment from the healthcare provider, Minn. R. 5221.6050, Subp. 9. C. An insurer must respond orally or in writing to: Approve the proposed treatment, Request additional information, Request a second opinion, Request an independent medical examination, or 4 Deny authorization. If authorization for treatment is denied, the insurer must notify the employee and health care provider why the treatment is being denied. The written denial must also advise the employee and provider that they have the right to a review of the denial by an appropriate health care professional. If the treatment parameters are relied upon as a reason for denying payment, the specific parameter must be cited. If the insurer does not respond in one of the aforementioned ways within seven working days, authorization for the proposed treatment is “deemed to have been given.” (Emphasis added) Minn. R. 5221.6050, Subp. 9. C. (1). The 45-day period contemplated by the medical treatment parameters governing requests for non-emergency surgery is calculated by calendar days, not working days. Paape v. City of So. St. Paul, slip op. (W.C.C.A. April 21, 2011). 4. Specific Treatment Parameters Guidelines were established in the parameters for some of the most common work-related injuries. The specific treatment parameters address low back pain, neck pain, thoracic back pain, upper extremity disorders, reflex sympathetic dystrophy, and chronic pain. The specific guidelines can be found under Minnesota Rules 5221.6200 to 5221.6600. The specific parameters address initial nonsurgical, surgical evaluation and chronic management phases. Each phase will not be required for every injury. The parameters cover the same categories for each specific injury and are as follows: Passive treatment modalities Active treatment modalities Therapeutic injections Surgery Chronic management Durable medical equipment Evaluation of treatment by health care provider Medication Additional specific parameters IV. MOST CONTROVERSIAL AND LITIGATED PARAMETERS A. Passive Treatment Modalities Passive Treatment Modalities are covered specifically in the specific permanent treatment parameters as follows: Low back pain – Minn. Rule 5221.6200, Subp. 3.C.(1-3), 5 Neck pain - Minn. Rule 5221.6205, Subp. 3.C.(1-3), Thoracic pain - Minn. Rule 5221.6210, Subp. 3.C.(1-3), and Upper extremity disorders - Minn. Rule 5221.6300, Subp. 3. C. (1-3). The parameters under these sections allow for adjustment or manipulation of joints, including chiropractic and osteopathic adjustments or manipulations, with a treatment response of three to five treatments. The maximum treatment frequency allowed by each section is up to five treatments per week for the first one to two weeks, with decreasing frequency thereafter. The parameters allow a maximum of twelve weeks of passive treatment. Twelve additional visits over the course of an additional year may be allowed if all of the following apply: (a) the employee is released to work or is permanently totally disabled and the additional passive treatment must result in progressive improvement in, or maintenance of, functional status achieved during the initial 12 weeks of passive care; (b) the treatment must not be given on a regularly scheduled basis; (c) the health care provider must document in the medical record a plan to encourage the employee's independence and decreased reliance on health care providers; (d) management of the employee's condition must include active treatment modalities during this period; (e) the additional 12 visits for passive treatment must not delay the required surgical or chronic pain evaluation required by this chapter; and (f) passive care is inappropriate while the employee has chronic pain syndrome. Passive treatment requested by an employee may continue beyond the additional twelve visits if approved by the insurer, commissioner, or a compensation judge. Where the Employee requested additional physical therapy treatment beyond an additional twelve visits, the W.C.C.A looked to Minn. R. 5221.6200, subp 3.B.(2) and weighed the factors including the employees’ subjective complaints of pain, functionality, and objective findings. Larsen v. Kraft Foods, Inc. and Amunrud v. Advance United Expressway, 2007 WL 2688585 (Minn.Work.Comp.Ct.App.) and 64 W.C.D. 204 (Minn.Work.Comp.Ct.App. 2004). The Court determined that approval of additional physical therapy treatment was unsupported by substantial evidence. The Court looked to the Treatment Parameters, applied them to the treatment requested, and found that additional treatment was not reasonable or necessary. 6 Because passive treatment may be allowed when a departure applies, also review Minn. Rule 5221.6050, subp. 8, discussed above. B. Therapeutic Injections Therapeutic injections are also covered in the each of the specific permanent treatment parameters: Low back pain – Minn. Rule 5221.6200, Subp. 5.C.(1-3), Neck pain - Minn. Rule 5221.6205, Subp. 5.C.(1-3), Thoracic pain - Minn. Rule 5221.6210, Subp. 5.C.(1-3),and Upper extremity disorders - Minn. Rule 5221.6300, Subp. 5. C. (1-3). Injections for RSD/Chronic Regional Pain Syndrome and like conditions are provided for separately under Minn. Rule 5221.6300, subp. 2A. Therapeutic injections can only be given in conjunction with active treatment modalities provided to the same anatomical site. The parameters under these sections provide specific time for treatment response, maximum treatment frequency, and maximum treatment for each of the following: (1) trigger point injections, (2) sacroiliac joint injections, (3) facet joint or nerve injections, (4) nerve root blocks, and (5) epidural injections. Healthcare providers often attempt to continue therapeutic injection treatment for the same injury beyond the scope of the treatment parameters’ maximum treatment requirements of “four injections to any one site,” by, for example, providing injections to a different site. It is noted that the use of injections for these specific injuries can extend past the 12-week limit on passive treatment modalities so long as the maximum treatment for injections is not exceeded. C. Lumbar Surgery and Arthrodesis Low back surgery, including decompression procedures and arthrodesis, is covered in Minn. R. 5221.6200, Subp. 6. This section first addresses the specific parameters outlined for regional low back pain (Subp.11); radicular pain, with or without regional low back pain, with no or static neurologic deficits (Subp. 12); or cauda equina syndrome and for radicular pain, with or without regional low back pain, with progressive neurologic deficits (Subp. 13). These parameters provide guidance when surgical evaluation, if indicated, may begin and where of the use of appropriate medical imaging techniques, diagnostic blocks and injections, personality or psychosocial evaluation, or consultation with other health care providers may be appropriate. Minn. R. 5221.6200, Subp. 11. B. (1-4). Spinal surgery for lumbar arthrodesis, with or without instrumentation, is addressed in Minn. R. 5221.6500, Subp. 2. C. 7 Currently most controversial are the requirements necessary to establish that surgery is reasonably required. Minn. R. 5221.6500, Subp. 2. C. (1) (a-d) requires that one of the following conditions must be satisfied to indicate the reasonable necessity of surgery: 1) unstable lumbar vertebral fracture, or 2) for a second or third surgery only, documented reextrusion or redisplacement of lumbar intervertebral disc after previous successful disc surgery at the same level and new lumbar radiculopathy with or without incapacitating back pain, 3) traumatic spinal deformity including a history of compression (wedge) fracture or fractures, or 4) incapacitating low back pain for longer than three months, and one of the following conditions involving lumbar segments L-3 and below is present: a. for the first surgery only, degenerative disc disease with postoperative documentation of instability created or found at the time of surgery, or positive discogram at one or two levels; or i. pseudoarthrosis, ii. for the second or third surgery only, previously operated disc; or iii. spondylolisthesis. D. Morphine Pumps A “morphine pump is indicated for a patient who has somatic pain, and is not a candidate for any other surgical therapy, and has had a favorable response to a trial screening period.” 5221.6200, Subp. 6. C. (2) Low Back Pain 5221.6205, Subp. 6. C. (2) Neck Pain 5221.6210, Subp. 6. C. (2) Thoracic Back Pain The WCCA addressed the use of a trial screening prior to implantation of a morphine pump in Feist v. Packaging of America/Tenneco, 61 W.C.D. 111 (Minn.Work.Comp.Ct.App. 2001). In Feist, the employee had treated for twelve years without significant relief, and the option of cervical surgery was explored, but rejected. There were no other surgical recommendations. The healthcare provider proposed a trial period of continuous spinal morphine. If the trial period was successful, the healthcare provider “would recommend implantation of a morphine pump.” Id. at 117. Since there are no prerequisites for the trial screening period in the treatment parameters, the court decided that there was substantial evidence that supported a determination that a morphine pump was “a reasonable treatment option which should be explored, and since it was clear that the appropriateness of this form of treatment could not be fully evaluated until after completion of a trial screening, a trial screening was reasonable under the circumstances.” Id. at 117. 8 E. Spinal Cord Stimulators A “dorsal column stimulator is indicated for a patient who has neuropathic pain, and is not a candidate for any other surgical therapy, and has had a favorable response to a trial screening period.” 5221.6200, Subp. 6. C. (1) Low Back Pain 5221.6205, Subp. 6. C. (1) Neck Pain 5221.6210, Subp. 6. C. (1) Thoracic Back Pain The use of a trial screening period prior to implantation of a spinal cord stimulator was similarly challenged. In the case of the spinal cord stimulator trial screening, the employer and insurer argued that the decision of the compensation judge to allow a trial screening period prior to implantation of a spinal cord did not satisfy the requirements of the treatment parameters. Brown v. REM Central Lakes, and Liberty Mutual Insurance Company, 69 W.C.D. 250 (Minn.Work.Comp.Ct.App. 2009). Unfortunately, the Court affirmed the compensation judge’s finding to allow the trial screening period before a second opinion was obtained or a psychological evaluation completed. The Court continued to follow the principles in Feist, noting that the treatment parameters concerning spinal cord stimulators do not apply to trial screenings. F. Botox Injections The treatment parameters dealing with therapeutic injections for the neck, thoracic spine, and low back each provide that botulinum toxin injections are not indicated and are not reimbursable. Nonetheless the use of Botox Injections was addressed in a case before the Minnesota Supreme Court. Hugill v. Benton County, 64 W.C.D.220, 230 (2004). In Hugill, the employee was seeking approval of Botox injections. The compensation judge denied the request and relied on the opinion of a doctor who wrote, “[i]n the absence of spasm, since none has been clearly documented on any regular occasion, I do not believe that . . . Botox injections [are] warranted.” On appeal, the employee argued the record was “replete” with medical records establishing the need for the injections. Ultimately, the employee cited only two medical records mentioning spasm. Further, the treating, and recommending physician, “offered very little explanation as to why he was recommending the injections.” The Court affirmed the decision of the compensation judge. Practice Tip: A denial of an Employee’s request for Botox Injection should be based on the principle that they are not reimbursable per the Treatment Parameters. It will then be a factual determination as to whether a departure is warranted. G. Opioids Minn. R. 5221.6105, Subp. 3. addresses parameters for the use of opioid analgesics. The rule states that opioids are indicated “for the symptomatic relief of acute and chronic pain that has been inadequately relieved by nonopioid medications.” Id. at A. 9 The rule requires the health care providers’ use of generic oral opioids and prescription of the lowest clinically effective dose of the medication. Id. at A-B. Minn. R. 5221.6105, Subp. 3.B.(2) does not allow for use of opioids for the symptomatic relief of acute or chronic pain, unless one-week trials of each of hydrocodone, oxycodone, and morphine have been ineffective in reducing the patient's pain by at least 50 percent as determined by the prescribing health care provider. The length of use is specifically outlined in Subp. 3. C. (1-3): 1) Oral opioid analgesics prescribed within the first four weeks after the date of injury are limited to no more than two weeks of medication per prescription. 2) Oral opioid analgesics prescribed more than four weeks after the date of injury may not be for more than one month of medication per prescription. 3) Oral opioid analgesics prescribed more than 12 weeks after the injury may be for more than one month of medication per prescription if there has been a clinical evaluation to confirm the need for an efficacy of the prescription and a clinical evaluation at least every six months thereafter during continued use of opiate analgesics. A request for a departure from the parameters regarding opioids was addressed in Rushmeyer v. Lyngblomsten Care Center, 2006 WL 3891512 (Minn.Work.Comp.Ct.App.). In Rushmeyer, although the employee’s use of Vicodin was found to be beyond that allowed under Minn. R. 5221.6200, Subp. 10, the Court applied the “rare case” exception to the treatment parameters. The compensation judge explained: This is a case where despite fusion surgery the employee continued to have intractable pain and has had this pain for many years. The employee is not a candidate for further surgery at this time. The employee's use of narcotics is closely monitored by her treating physicians. There is no evidence of abuse of narcotics. There is no alternate treatment for the employee's intractable pain being proposed at this time that the employer and insurer are willing to pay for. The employer contended that this finding was unsupported by substantial evidence, that the evidence did not support a contention the medication regimen was reasonable and necessary, and that the facts did not support a finding of a ‘rare exception.’ The W.C.C.A., however, found that the judge’s award was supported and upheld the departure from the treatment parameters. Adjusters and defense attorneys must pay attention to and analyze how a specific treatment request is not a rare exception. 10 H. Chronic Pain Treatment Modalities Minnesota Rule 5221.6600 addresses chronic management of all physical injuries, even not specifically governed under 5221.6200 – 5221.6500: If a patient continues with symptoms and physical findings after all appropriate initial nonsurgical and surgical treatment has been rendered, and if the patient’s condition prevents the resumption of the regular activities of daily life including regular vocational activities, then the patient may be a candidate for chronic management. Minn. Rule 5221.6600 Subp. 1. The rule’s purpose is clear: (1) the employee should be made independent of health care providers in the ongoing care of a chronic condition; and (2) the employee should be returned to the highest functional status reasonably possible. Personality or psych evaluation may be indicated per Subp. 1(A). No further passive treatment modalities or therapeutic injection are indicated at this point, except as otherwise provided by the rule. No further diagnostic evaluation is indicated unless there is a development of symptoms or physical findings which would warrant diagnostic evaluation. Minn. Rule 5221.6600 Subp. 1(C and D). A chronic management program must include appropriate means by which scheduled medications can be discontinued or severely limited. Minn. Rule 5221.6600 Subp. 1(E). Any of the following modalities can be used singly or in combination as part of a chronic management program per Subp. 1(B) and Subp. 2.: a. b. c. d. e. f. Home-based exercise programs; Health clubs; Computerized exercise programs; Work conditioning and work hardening programs; Chronic pain management programs; and/or Individual or group psychological or psychiatric counseling. For each chronic management modality, except home-based exercise programs, the health care provider must provide prior notification. Prior notification is required for home-based exercise programs if durable medical equipment is prescribed for home use. Insurers may not deny payment for a chronic management program previously authorized without providing the employee and the employee’s health care provider with at least 30 days notice of intent to apply any of the chronic management parameters in 11 Rule 5221.6600 to future treatment. The notice must include the specific parameters that will be used in determinations of compensability. I. Durable Medical Equipment Included in the specific parameters addressing the low back, neck, thoracic back, and upper extremity disorders is a discussion on durable medical equipment. In each specific parameter, the subsection (Subd. 8) concerning durable medical equipment outlines that whirlpools, Jacuzzis, hot tubs, special bath or shower attachments, beds, waterbeds, mattresses, chairs, recliners and loungers are not indicated for home use. V. CONCLUSION The Treatment Parameters were intended to clarify the reasonableness and necessity of treatment proposed by healthcare providers. Less clear, however, is how to navigate the Parameters. While the courts have issued decisions making application of the Treatment Parameters more difficult, there is evidence of success in use of the parameters. Keep in mind that a denial to a request for treatment must include an explanation as to why the treatment is being denied and, if the treatment parameters are relied upon as a defense, there must be a specific citation to the parameter that is being relied upon. 12