1 Policy: Manual Manipulation Therapy Clinical Decision ... · Manual Manipulation Therapy Clinical Decision-Assist Guideline Revised October 5, 2005 To CQT for review and recommendations

Policy CPG UM 12 Revision 3

Page 1 of 33 Policy CPG UM 12 Revision 3 Manual Manipulation Therapy Clinical Decision-Assist Guideline Revised October 5, 2005 To CQT for review and recommendations 8/9/05 To Dr. Mines for additional recommendations 8/20/05 CQT reviewed and approved additional recommendations To CPRC for review and approval 10/4/05 CPRC reviewed and approved 10/4/05 To CQOC for review and approval 10/5/05 Written Consensus CQOC reviewed and approved 10/5/05 Written Consensus

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Policy: Manual Manipulation Therapy Clinical Decision-Assist Guideline Date of Implementation: February 5, 2004 Contact: Clinical Care Management Clinical Quality Management 8

9 Medical Necessity 10

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American Specialty Health Affiliates (ASHA) clinical services managers evaluate medical necessity of services consistent with the definition of medical necessity adopted by ASHA Corporate Quality Oversight Committee. “Medically Necessary” or “Medical Necessity” shall mean health care services that a Healthcare Provider, exercising Prudent Clinical Judgment, would provide to a patient for the purpose of evaluating, diagnosing, or treating an illness, injury, disease or its symptoms, and that are (a) in accordance with Generally Accepted Standards of Medical Practice; (b) clinically appropriate in terms of type, frequency, extent, site, and duration; and Considered Effective for the patient’s illness, injury, or disease; and (c) not primarily for the Convenience of the Patient or Healthcare Provider, and not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury, or disease. (See UM 8 - Medical Necessity Definition)

Core Clinical Review Elements Critical to Manual Manipulation Therapy Utilization 26 Management Decision-Making 27

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It is important to note that critical peer-evaluation of medical necessity of services, especially within the diagnosis groups representing NMS disorders, requires the practitioner to approach the clinical data and scientific evidence from a global perspective synthesizing the various elements into a congruent clinical picture. The following is provided to assist the clinical evaluation cognitive process. Historical Elements • Onset mechanism and date of onset are appropriate for neuromusculoskeletal (NMS)

etiology; • Past history of NMS conditions and response to care does not contraindicate manual

manipulative therapy;



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• Past history of pertinent related and unrelated medical conditions does not contraindicate manual manipulative therapy management;

• Chief complaint has NMS component amenable to manual manipulative therapy; • Disability and impairment related to past history or chief complaint [e.g., performance of

activities of daily living (ADLs)]; • VAS scale (or other patient self-assessment tools) and outcome measurement goals are

implemented to establish a baseline and progress assessment. These tools are taken into consideration during treatment planning.

Examination Elements • Examination procedures and intensity are appropriate for the chief complaint and

historical findings; • Objective palpatory, orthopedic, neurologic, and other physical examination findings are

appropriately documented, including the nature, extent, severity, character, and significance of the finding in relation to the chief complaint, the diagnosis, and treatment planning;

• Examination findings provide a reasonable and reliable basis for the stated diagnosis and treatment planning, taking into account variables such as age, sex, physical conditioning, occupational and recreational activities, co-morbid conditions, etc.

Radiographic or Special Study Elements (CT, MRI, NCV, lab* if available) • Laboratory tests are performed only when medically necessary to improve diagnostic

accuracy and treatment planning. Abnormal values are interpreted as they related to the NMS chief complaint or to unrelated co-morbid conditions that may or may not be contraindications to manual manipulative therapy;

• X-ray procedures are performed only when medically necessary to improve diagnostic accuracy and treatment planning. Indicators from history and physical examination indicating the need for X-ray procedures are described in ASHA CPG UM 1 X-Ray Guidelines.

• Advanced imaging studies, when medically necessary and/or available, are evaluated for structural integrity and to rule out osseous or related soft tissue pathology;

• NCV studies, when medically necessary and/or available, are evaluated for objective evidence of neural deficit.

*ASHA generally does not cover special studies (e.g., CT, MRI, NCV) and lab services; ASHA does cover medically necessary plain-film x-ray; however, all these findings are considered if provided to the ASHA reviewer. Treatment Planning Elements • Dosage (frequency and duration of care) is appropriately correlated with clinical findings

and clinical evidence;



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• Therapeutic goals are realistic, measurable, and evidence-based; • Proposed date of release/discharge from treatment is clearly defined; • Treatment/therapy type and relationship to condition and goals are appropriate; • Determining if a patient is making clinically significant progress is important in order to

determine the need for continued care, the appropriate frequency, estimated date of release from care, and if a change in the treatment plan or a referral to an appropriate health care provider is indicated. In general, perceived percent improvement (on pain scale, functional scale, or other self-assessment tool) is more valuable than raw scores. Improvement of 15-20% or more has been suggested in the literature as significant. Actual significance requires correlation with the overall clinical presentation, including updated subjective and objective examination findings;

• Home care, self-care, and active-care instructions are documented; • Durable Medical Equipment (DME), Supplies, and Supports are provided when

medically necessary and appropriately correlated with clinical findings and clinical evidence.

Approve manual manipulative therapy services if: • Covered service(s); • Covered condition(s); • Amenable to manual manipulative therapy; • No evidence of contraindication to manual manipulative therapy; • Documentation supports practitioner’s diagnosis and treatment plan; • Clinically significant progress is evident through submitted records; • Demonstration of progression toward active home/self care and discharge.

Deny or modify manual manipulative therapy services if: • Not a covered service; • Primary diagnosis is not a covered condition; • Lack of documentation to support the diagnosis; • Treatment/therapy is inappropriate or unrelated to the condition; • Red flags present through history and physical examination and/or response to care

requiring urgent attention, further testing, and/or possible specialist referral; • Initial trial of care is unsuccessful; • Preventive or maintenance/elective care; • Case requires referral to PCP or other specialty; • Clinically significant therapeutic progress is not evident through assessment of the

records submitted, indicating maximum therapeutic benefit or maximum medical improvement has been reached;

• Patient has returned to pre-clinical status; • Evidence of treatment dependency and/or presence of Yellow Flags (subjective risk

factors with a psychosocial predominance associated with chronic pain and disability).



1 Detailed Clinical Decision-Making Elements 2

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The following informational tables provide the clinical elements considered by the clinical services manager when reviewing clinical documentation submitted by a treating practitioner. A single symptom or clinical finding, in isolation, generally will not define the appropriate approval or denial of services. The entire clinical picture must be taken into account. Specific contraindications to proposed interventions may result in denial of care. Table A: Guidelines for Determining Condition Severity

Criteria Mild Conditions Moderate Conditions Severe Conditions

Severity of Pain (1–10 scale)

1–4

5–7

8–10

Anticipated Duration of Care

1–6 weeks 6–10 weeks 10 or more weeks

Activities of Daily Living (ADLs) Minimal or no effect on ADLs May have some effect on

ADLs Considerable effect on ADLs

Self Rating of Effect on ADLs (1-10)

1–4

5–7

8–10

Exam Findings: 1) Range of Motion 2) Palpatory Tenderness 3) Neurologic Findings 4) Orthopedic Testing

Consistent with mild severity: •Mild or no loss •Mild to moderate •None •Variable

Consistent with moderate severity: •Mild to moderate loss •Moderate to marked •None •Variable

Consistent with severe conditions: •Considerable or excessive loss •Marked or severe •May be present •Positive findings with pain

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Guidelines are included for the following conditions:

Spinal Somatic Pain • Approval of new treatment plan



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• Approval of continuing treatment plan • Denial of new or continuing treatment plan • Cases that require referral or coordination of care

Headache

• Approval of new treatment plan • Approval of continuing treatment plan • Denial of new or continuing treatment plan • Cases that require referral or coordination of care

Extremity Pain/Dysfunction

• Approval of new treatment plan • Approval of continuing treatment plan • Denial of new or continuing treatment plan • Cases that require referral or coordination of care



Spinal Somatic Pain1 2 3 4 5 6 7 8

(e.g., spinal subluxation, lumbar sprain/strain, cervical sprain/strain, thoracic sprain/strain, myalgia, arthralgia, discopathy, myofascitis,

cervical-brachial radiculopathy, sciatica) Approve appropriate dosage of care under first treatment plan for the present episode. Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Acute or Sub-Acute Episode (symptoms present <6 weeks for acute and up to 12 weeks for sub-acute): • Rapid onset; insidious or

traumatic; may be flare-up of previous condition

• Mild, moderate, or severe pain

• Functional deficit may be reported

• Absence of signs and symptoms suggesting red flag conditions (e.g., infection, metastatic disease, progressive and/or gross neurological deficit)

• Absence of yellow flags (subjective risk factors with a psychosocial predominance associated with chronic pain and disability)

• May have restrictions in specific ADLs

The severity of the clinical findings that support a spinal somatic pain diagnosis and the initiation of a trial of care should be considered. (See Table A) There must be coherence between history, examination findings, diagnosis, and treatment plan. Absence of clinical findings that may contraindicate the initiation of a trial of care: • Infection, fracture, or organic

pathology • Malingering signs

Approve the level of care necessary for acute pain/symptom relief and functional improvement as indicated by: • Condition severity • All submitted pertinent clinical

evidence (diagnostic evidence and/or therapeutic functional outcome evidence determined to be valid and reliable during the clinical assessment and the treatment plan/program)

• Evidence-based documented evidence

• Peer-consensus evidence (if valid scientific documented evidence of diagnostic or therapeutic reliability and reproducibility is non-existent)

• CSM experience guided by the above and • an understanding that similar case presentations should be handled in similar fashion in order to produce reasonably consistent results; • consideration that, for a given diagnosis, the effect of variability in general health status (age, gender, past



medical history, psychosocial factors, and presence of co-morbid conditions) may influence the appropriate dosage of care.

Acute episodes of uncomplicated spinal somatic pain are typically approved for a 30-day trial of care. Clinical services managers are trained to identify variations in clinical presentation that may influence the approval of a treatment plan.

Chronic (Symptoms present for 12 weeks or >): • Rapid onset; insidious or







• Non-pediatric (13 years

The severity of the clinical findings that support a spinal somatic pain diagnosis and the initiation of a trial of care should be considered. (See Table A) There must be coherence between history, examination findings, diagnosis, and treatment plan. Absence of clinical findings that may contraindicate the initiation of a trial of care: • Infection, fracture, or organic


Approve the level of care necessary for chronic pain/symptom relief and functional improvement as indicated by: • Condition severity • All submitted pertinent clinical




• CSM experience guided by the above and • an understanding that similar case presentations should be handled in similar fashion in order to produce



of age and older) • Prior similar treatment

has been successful • Ongoing or recurrent

functional deficit

reasonably consistent results • consideration that, for a given diagnosis, the effect of variability in general health status (age, gender, past medical history, psychosocial factors, and presence of co-morbid conditions) may influence the appropriate dosage of care

A trial of care for chronic spinal somatic pain is typically approved for a 30 to 60-day period. If the trial of therapy shows no improvement within the first few weeks, it is unlikely that undergoing the same course of treatment will change those results. If the trial of therapy shows slow but continuing improvement, the treatment episode may be extended to enhance those results. For PRN (as needed) care for cases justifying the need for supportive care1: • Approve the level of care that

has previously shown to be effective in reducing or alleviating the member’s pain/symptoms (up to 4 months)

• The risk of treatment dependency should always be considered.

Clinical services managers are trained to identify variations in clinical presentation that may



influence the approval of a treatment plan.

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1Supportive care is treatment for patients who have reached maximum therapeutic benefit, but who fail to sustain this benefit and progressively deteriorate when there are periodic withdrawals of treatment. Supportive care follows appropriate application of passive and active care including rehabilitation and lifestyle modifications. It is appropriate when rehabilitative and/or functional restorative and alternative care options, including home-based self-care and lifestyle modifications, have been considered and attempted. Supportive care may be inappropriate when it interferes with other appropriate primary care, or when the risk of supportive care outweighs its benefits, i.e., physician dependence, somatization, illness behavior, or secondary gain. [Haldeman, S., Chapman-Smith, D., Petersen, D.M. (Eds.). (1993). Guidelines for Chiropractic Assurance and Practice Parameters. (Ch. 8, p. 118, and Ch. 13, p. 181). Aspen Publishing.] Approve appropriate dosage of care under continuation of a treatment plan for an ongoing episode. Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Improvement reported but not to pre-clinical status such as: • Pain improved

significantly • Frequency of symptoms

substantially decreased • Functional deficit absent

or significantly improved as compared to baseline

• Centralization of referred and/or radiating pain if symptoms were originally present

Additionally: • Transitioning from

passive to active care • Confirm appropriate

coordination of other

Clinical findings that support the continuation of care for an ongoing episode should include the following: • Improved orthopedic and/or

neurological findings • Decreased tenderness • Hypertonicity improved • Increased ROM at area of

complaint • Increased ability to perform

ADLs • Coherence between the

member’s response to care and the new treatment proposal

Absence of clinical findings that may contraindicate the initiation of a trial of care:

Approve the level of care necessary for pain/symptom relief and functional improvement if: • The member has made

reasonable progress toward pre-clinical status or functional outcomes under the initial treatment/services

• Additional significant improvement can be reasonably expected by continued treatment

• The member has not reached maximum therapeutic benefit (MTB) or maximum medical improvement (MMI)

• There is no indication that immediate care/evaluation is required by other health care professionals.



appropriate health care services, if necessary


• Absence of yellow flags or treatment dependency

• Transition from passive to active care

• Member complying with treatment plan (e.g., willingness to make necessary lifestyle changes to help reduce frequency and intensity of symptoms

• No signs that the need for additional care is due to new complicating factors or misdiagnosis

• Infection, fracture, organic pathology, or malingering signs

Uncomplicated subluxation diagnoses do not typically require care beyond the initial treatment plan. Ongoing care for an acute episode of spinal somatic pain is typically approved in 30 to 60-day increments. Frequency of care generally decreases as symptoms and clinical findings improve. Prolonged reliance on passive care is not supported by the clinical literature. Ongoing care for a chronic or recurring episode of spinal somatic pain is typically approved in 30 to 60-day increments. The risk of treatment dependency should always be considered. Transition from passive to active treatment modalities should be considered in the determination of medical necessity of ongoing care. Clinical services managers are trained to identify variations in clinical presentation that may influence the approval of a treatment plan.

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Deny new or continuing treatment plan for the present episode. Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Initial Treatment Plan: • No onset reported or

available from prior submissions

• VAS pain score pain ≤1 • No functional deficit

reported • Wellness exam,

pre-employment exam, pre-participation sports physical, or preventive/elective care

• Signs and symptoms suggesting red flag conditions (e.g., infection, metastatic disease, progressive and/or gross neurological deficit)

• Evidence of treatment dependency and/or presence of yellow flags

Essentially normal exam, including but not limited to: • +0 to +1 Tenderness • +0 to +1 Hypertonicity • Normal regional ROMs Additionally: • Poor coherence between history,

examination findings, diagnosis, and treatment plan

• Signs of active cerebrovascular involvement

• Signs of vertebrobasilar involvement

• Signs of neurological compromise

• Malingering signs • Treatment proposed under a

Medicare plan that does not include required elements of P.A.R.T.2 for spinal subluxation.

2 To demonstrate a subluxation, two of the four P.A.R.T. criteria are required, one of which must be an A or an R. The precise level of subluxation must be described and the symptoms must be related to the level of subluxation cited and whether the particular vertebra listed is capable of producing pain in the area determined. The mere statement or diagnosis of pain is not sufficient to support medical necessity for treatments. (Centers for Medicare & Medicaid Services. Carriers Manual Part 3 Chapter II, subsection 2251.2. Retrieved 27 June 2005 from http://www.cms.hs.gov/ manuals/14_car/ 3b2250.asp)

Deny the care submitted by practitioner as indicated by: • Unremarkable member history • Minimal or no clinical findings • Care is preventive or

maintenance/elective care • Treatment proposed for non-

NMS disorder (e.g., asthma, Parkinson’s disease, hypertension)

• Non-subluxation condition under Medicare contracts



Ongoing Care: • Insufficient response to

initial trial of care • Member has returned to

pre-clinical status • Member has reached

maximum therapeutic benefit (MTB) or maximum medical improvement and supportive care1 is not indicted

• Additional care is preventive or maintenance/elective care

• Presence of signs and symptoms suggesting red flag conditions (e.g., infection, metastatic disease, progressive and/or gross neurological deficit)


Same factors as with initial treatment plan in addition to: • Examination findings have

returned to pre-clinical status • Minimal to no improvement

in physical findings present following 2 successive re-examinations

Deny care submitted by practitioner as indicated by: • Member has returned to pre-

clinical status • Maximum therapeutic benefit is

suspected when minimal to no improvement in physical findings is evident following 2 successive re-examinations

• No probability that the condition will continue to improve significantly and/or resolve with additional treatment

• Referral may be an option • Non-subluxation condition

under Medicare contracts

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Need for referral or coordination of care for new or continuing member.

Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Acute or Chronic: • Symptoms worsening

following treatment • Deteriorating condition • No progress despite

treatment • Unexplained diagnostic

findings • Red flags identified (e.g.,

• Rapidly deteriorating orthopedic and/or neurological findings

• Clinical and historical findings indicating potential for vertebrobasilar compromise (cervical)

• Cauda equina findings (lumbar)

• Recommend referral of the member to PCP or other appropriate health care practitioner with the measure of urgency as warranted by the history and clinical findings.

• Appropriately document all

communication with attending



signs and symptoms of infection, metastatic disease, progressive and/or gross neurological deficit)

• Peripheralization of referred or radiating pain or deterioration of neurological findings

• Deterioration of functional capacity

• Identification of co-morbid conditions (e.g., history of stroke or TIAs, progressive spondylolithesis, moderate to severe hypertension, inflammatory arthritis, joint hyper-mobility, benign bone tumors, osteopenia, bleeding disorders or anticoagulant therapy) that represent relative contraindications to spinal manipulative care

• Constant, progressive non-mechanical pain

• Systemically unwell (e.g., weight loss of greater than 4.5 kg over 6-month period

• Evidence or suspicion of spinal fracture

• Clinical findings outside scope of treatment

• Pain not provoked and/or relieved through physical examination procedures

practitioner. • Recommend referral to PCP or

other appropriate health practitioner if member is pediatric age (12 years of age and under) and has other than a mild to moderate NMS condition.

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1 Headache 2

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(e.g., cervicogenic headache, classical migraine, tension headache)

Approve appropriate dosage of care under first treatment plan for the present episode. Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Acute or Sub-Acute: • First or uncommon event

for the member • Mild, moderate, or severe

pain • Functional deficit may be

reported • Absence of signs and

symptoms suggesting red flag contraindications (e.g., stroke, infection, tumor, gross or progressive neurological deficit, uncontrolled hypertension)

• Absence of yellow flags (e.g., subjective risk factors with a psychosocial predominance associated with chronic pain and disability)

• Report of common headache “triggers” (e.g., stress, anxiety, fatigue, hunger, anger, poor posture, or overexertion)

• Headache type known to be responsive to manual manipulative therapy

• Unavailability of treatment alternatives that are likely to provide a

The severity of the clinical findings that support a headache diagnosis and the initiation of a trial of care should be considered. (See Table A) In addition, the following elements of examination should be considered specific to the headache diagnosis: • Neurologic exam (CNS and

peripheral) • Vascular examination,

including but not exclusive to normal blood pressure

• Trigger points and/or local hypertonic muscles

There must be coherence between history, examination findings, diagnosis, and treatment plan. Absence of clinical findings that may contraindicate the initiation of a trial of care: • Infection, fracture, or organic


Approve the level of care necessary for acute pain/symptom relief and functional improvement as indicated by condition severity: • All submitted pertinent clinical

evidence (diagnostic evidence and/or therapeutic functional outcome evidence determined to be valid and reliable during the clinical assessment and the treatment plan/program);


• Peer-consensus evidence (if valid scientific documented evidence of diagnostic or therapeutic reliability and reproducibility is non-existent

• CSM experience guided by the above and • an understanding that similar case presentations should be handled in similar fashion in order to produce reasonably consistent results; • consideration that, for a given diagnosis, the effect of variability in general health status (age, gender, past medical history, psychosocial factors, and presence of co-morbid conditions) may influence the appropriate



more favorable outcome dosage of care. Acute episodes of uncomplicated headache are typically approved for a 30-day trial of care. Clinical services managers are trained to identify variations in clinical presentation that may influence the approval of a treatment plan.

Chronic (symptoms present for 12 weeks or more): • History and complaint are

similar to previous episodes reported by member

• Mild, moderate, or severe p


• Previous treatment has been successful

• Absence of signs and symptoms suggesting red flag contraindications (e.g., stroke, infection, tumor, gross or progressive neurological deficit, uncontrolled hypertension)


• Unavailability of treatment alternatives that are likely to provide a

Clinical findings that support the initiation of a trial of care for a headache diagnosis should include the following: • Neurologic exam (CNS and

peripheral) • Vascular examination,

including but not exclusive to normal blood pressure

• Trigger points and/or local hypertonic muscles

• Coherence between history, examination findings, diagnosis, and treatment plan

Absence of clinical findings that may contraindicate the initiation of a trial of care: • Infection, fracture, or organic


Approve the level of care necessary for pain/symptom relief and functional improvement as indicated by: • Condition severity; • All submitted pertinent clinical



• Peer-consensus evidence (if valid scientific documented evidence of diagnostic or therapeutic reliability and reproducibility is non-existent

• CSM experience guided by the above and: • an understanding that similar case presentations should be handled in similar fashion in order to produce reasonably consistent results • consideration that, for a given diagnosis, the effect of variability in general health



more favorable outcome status (age, gender, past medical history, psychosocial factors, and presence of co-morbid conditions) may influence the appropriate dosage of care.

A trial of care for chronic headache is typically approved for a 30 to 60-day period. If the trial of therapy shows no improvement within the first few weeks, it is unlikely that undergoing the same course of treatment will change those results. If the trial of therapy shows slow but continuing improvement, the treatment episode may be extended to enhance those results. For PRN (as needed) care for cases justifying the need for supportive care1: • Approve the level of care that

has previously shown to be effective in reducing or alleviating the member’s pain/symptoms (up to 4 months)

• The risk of treatment dependency should always be considered

Clinical services managers are trained to identify variations in clinical presentation that may influence the approval of a treatment plan.

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Approve appropriate dosage of care for continuation of a treatment plan for the present episode Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Improvement reported from present treatment plan but not to pre-clinical status • Pain substantially

decreased • Frequency and/or

duration of headache substantially decreased

• Functional deficit absent or significantly improved as compared to baseline

Additionally: • Confirm appropriate

coordination of other appropriate health care services, if necessary

• Absence of signs and symptoms suggesting red flag contraindications (e.g., stroke, infection, tumor, gross or progressive neurological deficit, uncontrolled hypertension)

• Absence of yellow flags or treatment dependency

• Transition from passive to active care

• Member complying with treatment plan (e.g., willingness to make necessary lifestyle changes to help reduce frequency and intensity of headache episodes

• Neurologic exam • Vascular exam • Improvement in NMS

examination findings (palpation, posture, tenderness, range of motion)

• Improvement of previous clinical findings (defined in terms of frequency or duration or intensity)

• No evidence of worsening objective examination findings



Approve the level of care necessary for pain/symptom relief and functional improvement if: • The member has made




• There is no indication that immediate care/evaluation is required by other health care professionals

Uncomplicated subluxation diagnoses do not typically require care beyond the initial treatment plan. Ongoing care for an acute episode of headache is typically approved in 30 to 60-day increments. Frequency of care generally decreases as symptoms and clinical findings improve. Prolonged reliance on passive care is not supported by the clinical literature.



• No signs that the need for additional care is due to new complicating factors or misdiagnosis

Ongoing care for a chronic or recurring episode of headaches is typically approved in 30 to 60-day increments. The risk of treatment dependency should always be considered. Transition from passive to active treatment modalities should be considered in the determination of medical necessity of ongoing care. Clinical services managers are trained to identify variations in clinical presentation that may influence the approval of a treatment plan.

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pre-employment exam, pre-participation sports physical, or preventive/elective care

• Worsening in symptoms • Red flags present (e.g.,

signs and symptoms of infection, metastatic disease, gross or progressive neurological deficit)

Essentially normal exam including but not limited to: • +0 to +1 Tenderness • +0 to +1 Hypertonicity Additionally: • Poor coherence between

history, examination findings, diagnosis, and treatment plan




• Malingering signs • Treatment proposed under a

Medicare plan that does not include required elements of

Deny the care submitted by practitioner as indicated by: • Unremarkable member history • Minimal or no clinical findings • Care is preventive or

maintenance/elective care • Referral may be an option




P.A.R.T2 for spinal subluxation




maximum therapeutic benefit (MTB) or maximum medical improvement and supportive care1 is not indicated


• Red flags present (e.g., signs and symptoms of infection, metastatic disease, gross or progressive neurological deficit)


Same factors as within initial treatment plan in addition to: • Examination findings have



• Worsening symptoms and objective findings and/or the onset of vascular and/or neurological findings

Deny the level of care submitted by practitioner as indicated by: • Member has returned to pre-



• No probability that the condition will continue to improve and/or resolve with additional treatment

• Referral may be an option

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Need for Referral or Co-Management of New or Continuing Patient Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Acute or Chronic: • Deteriorating condition • Worsening symptoms

following treatment • Unexplained diagnostic

findings • Awakened in the night

• Central nervous system deficit or evidence of a space-occupying lesion

• Clinical and historical findings indicating potential for vertebrobasilar compromise.

Recommend referral of the member to PCP or other appropriate health care practitioner with the measure of urgency as warranted by the history and clinical findings. Appropriately document all



with severe headache • Headache accompanied

by fever • No progress despite

treatment • Presence of red flags

(e.g., signs and symptoms of stroke, infection, metastatic disease, gross or progressive neurological deficit)

• Unremitting or progressive headache pain, visual disturbance other than migraine aura

• Identification of co-morbid conditions (e.g., history of stroke or TIAs, moderate to severe hypertension, inflammatory arthritis, joint hyper-mobility, benign bone tumors, osteopenia, bleeding disorders or anticoagulant therapy) that represent relative contraindications to spinal manipulative care

• Systemically unwell (weight loss great than 4.5 kg over 6-month period)



• Pain not provoked and/or relieved through physical examination procedures

communication with attending practitioner. Recommend referral to PCP or other appropriate health practitioner if member is pediatric age (12 years of age and under) and has other than a mild to moderate NMS condition.

1



Extremity Pain/ Dysfunction Conditions 1 2 3 4 5 6 7 8 9

(e.g., carpal tunnel syndrome; lateral epicondylitis; wrist tendonitis; somatic/segmental dysfunction syndromes of the upper or lower

extremities; rotator cuff syndromes; patellofemoral syndromes; plantar fasciitis; sprain/strain of the extremity; arthritic conditions)

Approve appropriate dosage of care under first treatment plan for the present episode. Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Acute or Sub-Acute Episode: • Rapid onset; insidious or




• Absence of signs or symptoms suggesting red flag conditions (e.g., infection, fracture, metastatic disease, progressive and/or gross neurological deficit, compartment syndromes, deep vein thrombosis, full tendon rupture, complicated fracture, avascular necrosis)



The severity of the clinical findings that support an extremity pain/dysfunction condition and the initiation of a trial of care should be considered. (See table A) Coherence between history, examination findings, diagnosis, and treatment plan Absence of clinical findings that may contraindicate the initiation of a trial of care: • Infection, fracture, or organic


Approve the level of care necessary for acute pain/symptom relief and functional improvement as indicated by: • Condition severity • All submitted pertinent clinical



• Peer-consensus evidence (if valid scientific documented evidence of diagnostic or therapeutic reliability and reproducibility is non-existent);

• CSM experience guided by the above and: • an understanding that similar case presentations should be handled in similar fashion in order to produce reasonably consistent results • consideration that, for a given diagnosis, the effect of



variability in general health status (age, gender, past medical history, psychosocial factors, and presence of co-morbid conditions) may influence the appropriate dosage of care

Acute episodes of uncomplicated extremity pain/dysfunction conditions are typically approved for a 30-day trial of care. Clinical services managers are trained to identify variations in clinical presentation that may influence the approval of a treatment plan.

Chronic: • History and complaint are

similar to previous episodes reported by member



• Absence of symptoms to suspect red flag conditions (e.g., infection, fracture, metastatic disease, gross or progressive neurological deficit, compartment syndromes, deep vein thrombosis, full tendon rupture, complicated fracture, avascular necrosis)

• Absence of yellow flags

The severity of the clinical findings that support an extremity pain/dysfunction condition and the initiation of a trial of care should be considered. (See table A) Coherence between history, examination findings, diagnosis, and treatment plan Absence of clinical findings that may contraindicate the initiation of a trial of care: • Infection, fracture, or organic


Approve the level of care necessary for pain/symptom relief and functional improvement as indicated by: • Condition severity • All submitted pertinent clinical




• CSM experience guided by the above and: • an understanding that



(subjective risk factors with a psychosocial predominance associated with chronic pain and disability)


• Non-pediatric (12 years of age and under)

• Prior similar treatment has been successful

• Ongoing or recurrent functional deficit

similar case presentations should be handled in similar fashion in order to produce reasonably consistent result • consideration that, for a given diagnosis, the effect of variability in general health status (age, gender, past medical history, psychosocial factors, and presence of co-morbid conditions) may influence the appropriate dosage of care

A trial of care for chronic extremity pain/dysfunction condition is typically approved for a 30 to 60-day period. If the trial of therapy shows no improvement within the first few weeks, it is unlikely that undergoing the same course of treatment will change those results. If the trial of therapy shows slow but continuing improvement, the treatment episode may be extended to enhance those results. For PRN (as needed) care for cases justifying the need for supportive care1

• Approve the level of care that has previously shown to be effective in reducing or alleviating the member’s pain/symptoms (up to 4 months)

• The risk of treatment dependency should always be considered



Clinical services managers are trained to identify variations in clinical presentation that may influence the approval of a treatment plan

1 2 3 4 5

Approve appropriate dosage of care under continuation of a treatment plan for an ongoing episode. Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Improvement reported but not to pre-clinical status such as: • Pain improved

significantly • Frequency of symptoms

substantially decreased • Functional deficit absent

or significantly improved as compared to baseline

Additionally: • Transitioning from

passive to active care • Confirm appropriate

coordination of other appropriate health care services, if necessary

• Absence of symptoms to suspect red flag conditions (e.g., infection, fracture, metastatic disease, gross or progressive neurological deficit, compartment syndromes, deep vein thrombosis, full tendon rupture, complicated fracture,

Clinical findings that support the continuation of care for an ongoing episode should include the following: • Improved orthopedic and/or

neurological findings • Decreased tenderness • Decreased hypertonicity • Increased ROM at area of

complaint • Increased ability to perform

ADLs • Coherence between the

member’s response to care and the new treatment proposal



Approve the level of care necessary for acute pain/symptom relief and functional improvement if: • The member has made




• There is no indication that immediate care/evaluation is required by other health care professionals

Uncomplicated subluxation diagnoses do not typically require care beyond the initial treatment plan. Ongoing care for an acute episode of extremity pain/dysfunction condition is typically approved in



avascular necrosis) • Absence of yellow flags

or treatment dependency

30 to 60-day increments. Frequency of care generally decreases as symptoms and clinical findings improve. Prolonged reliance on passive care is not supported by the clinical literature. Ongoing care for a chronic or recurring episode of extremity pain/dysfunction condition is typically approved in 30 to 60-day increments. The risk of treatment dependency should always be considered. Transition from passive to active treatment modalities should be considered in the determination of medical necessity of ongoing care. Clinical services managers are trained to identify variations in clinical presentation that may influence the approval of a treatment plan.

1 2 3 4






pre-employment exam, pre-participation sports

Essentially normal exam including but not limited to: • +0 to +1 Tenderness • +0 to +1 Hypertonicity • Normal regional ROMs Additionally: • Poor coherence between

history, examination findings, diagnosis, and treatment plan

Deny the level of care submitted by practitioner as indicated by: • Unremarkable member history • Minimal or no clinical findings • Care is preventive or

maintenance/elective care • Treatment proposed for non-

NMS disorder (e.g., asthma, Parkinson’s disease, hypertension)



physical, or preventive/elective care

• Signs and symptoms present to suspect red flag conditions (e.g., infection, fracture, metastatic disease, gross or progressive neurological deficit , compartment syndromes, deep vein thrombosis, full tendon rupture, complicated fracture, avascular necrosis)








maximum therapeutic benefit (MTB) or maximum medical improvement and supportive care1 is not indicted


• Red flags identified (e.g., signs of infection, fracture, metastatic disease, gross or progressive neurological deficit, compartment syndromes, deep vein thrombosis, full tendon

Same factors as within initial treatment plan in addition to: • Examination findings have



Deny the level of care submitted by practitioner as indicated by: • Member has returned to pre-



• No probability that the condition will continue to improve significantly and/or resolve with additional treatment

• Referral may be an option



rupture, complicated fracture, avascular necrosis)


1 2 3 4

Need for referral or coordination of care new or continuing patient.

Patient History/Complaint Clinical Findings Action by Clinical Services

Manager Acute or Chronic: • Deteriorating condition • No progress despite

treatment • Red flags identified (e.g.,

signs of infection, fracture, metastatic disease, gross or progressive neurological deficit, compartment syndromes, deep vein thrombosis, full tendon rupture, complicated fracture, avascular necrosis)

• Deterioration of functional capacity

• Identification of co-morbid conditions (e.g., inflammatory arthritis, joint hyper-mobility, benign bone tumors, osteopenia, bleeding disorders or anticoagulant therapy) that represent relative contraindications to spinal manipulative care

• Constant, progressive

• Rapidly deteriorating orthopedic and/or neurological findings


• Signs present to suspect red flag conditions (e.g., infection, fracture, metastatic disease, gross or progressive neurological deficit, compartment syndromes, deep vein thrombosis, full tendon rupture, complicated fracture, avascular necrosis)

Recommend referral of the member to PCP or other appropriate health care practitioner with the measure of urgency as warranted by the history and clinical findings. Appropriately document all communication with attending practitioner. Recommend referral to PCP or other appropriate health practitioner if member is pediatric age (12 years of age and under) and has other than a mild to moderate NMS condition.



non-mechanical pain • Systemically unwell (e.g.,

weight loss of greater than 4.5 kg over 6-month period

1 2

Guideline Rationale 3 4 5 6 7 8 9

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In the development of clinical guidelines and their applications to the clinical decision-making process of ASHA, clinical services managers are guided by the following principles. The utilization management policies of ASHA are developed through the application of the principles of Evidence-Based-Health-Care (EBHC). Very broadly, EBHC advances these ideas: 1. A reliance on the original clinical scientific literature as the primary source of evidence. 2. An understanding of the rules of evidence in the evaluation of clinical scientific

literature. 3. An understanding of the inherent limitations of experience, custom, and common sense

as a guide to clinical effectiveness. 4. An understanding of the inherent limitations of basic science (in the absence of clinical

science) as a guide to clinical effectiveness. EBHC is not about proof or certainty. It is a method of dealing with uncertainty. It is about weighing the evidence and weighing alternatives. EBHC recognizes the limitations and inherent unreliability of uncontrolled clinical observations and impressions and the inevitability of mistaken conclusions based on those uncontrolled observations. EBHC stresses the importance of outcomes-based clinical research, of regularly consulting original literature, and of understanding certain rules of evidence in order to evaluate that literature. In applying these principles, the goal is to limit the range of acceptable diagnostic and treatment options that a clinician may consider. At the most extreme, the range of options might be limited to a single management profile. That is, there is one permitted diagnostic and treatment regimen while all others are proscribed. Something close to this extreme has been implemented in some well-defined clinical circumstances such as the diagnosis and treatment of suspected urinary tract infection (UTI). For the types of conditions (musculoskeletal pain) that represent the bulk of ASHA cases, a parallel set of rigid guidelines is particularly unsuitable. A given diagnosis with a given set of clinical findings has very poor predictive powers as to the prognosis of the case. In aggregate, it may be possible to make some concrete and specific statements about the



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10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33

probable course of 1000 cases of low back pain, but it is not possible to make such statements about a single case. Indeed, it is not yet possible to accurately identify the source of pain in the majority of cases of low back pain. In essence, every treatment episode is a trial of therapy. If the trial is rapidly successful, the member is discharged in a few visits. If the trial of therapy shows no improvement within those first few weeks, it is unlikely that continuing the same course of treatment will change these results. And if the trial of therapy shows slow but continuing improvement, the treatment episode will be extended to maximize the clinical results. None of these outcomes is knowable on the basis of a given set of findings at the outset of the trial of therapy. This being said, it does not follow that no standards can be applied to these conditions or that EBHC is not relevant to the problem. In applying EBHC to the management of musculoskeletal pain syndromes, the following sets of clinical literature are specifically considered: • Natural history of condition • The ability of specific diagnostic procedures (e.g., imaging) to make meaningful

distinctions among episodes of condition; • The safety and efficiency profiles of such diagnostic procedures • Relative safety and effectiveness of proposed treatment [e.g., spinal manipulative therapy • (SMT)] • Relative safety and effectiveness of available alternate treatments (e.g., NSAIDS) • Cost of proposed intervention. The existing clinical science on the management of back or neck pain, headaches, or other musculoskeletal pain syndromes does provide a few instances of clinical absolutes. For example (with back pain), the clinical literature provides fairly conclusive evidence that surgical interventions for back pain should be used only if (a) there are significant neurological deficits; (b) the condition has proven refractory to more conservative interventions; and (c) a reasonable period of time has elapsed (up to 6 months) since the onset of the condition. The literature also provides definitive evidence that prescribed bed rest, and particularly in-patient bed rest, is absolutely proscribed beyond a very limited time period (about 36 hours).



Clinical Principles 1 2 3 4 5 6 7 8 9

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The existing clinical science on back pain provides the following less absolute principles upon which clinical decisions can be made. • The natural history of most cases of back pain is likely benign, with most cases capable

of ultimate self-resolution within a period of several months. • This symptomatic period may be reduced by the application of certain conservative

interventions. • A recurrence of back pain following resolution is likely. • Routine spinal radiographs are not indicated for the evaluation of spinal pain syndromes

in the absence of specific clinical findings (refer to ASHA CPG UM 1 X-Ray Guidelines).

• Advanced imaging (CT/MRI) is not typically indicated except in cases where significant neurological deficits already exist. Decisions regarding advance imaging are made on a case by case basis.

• A thorough history and physical/neurological exam are sufficient to identify red flags, which may require more aggressive evaluation.

• There is little evidence of effectiveness for passive physical therapy modalities (ultra-sound, electrical muscle stimulation, etc.) beyond the acute phase of care (6 weeks).

• Overall, passive therapy should be limited. Reaching an active rehabilitation phase of care as rapidly as possible and minimizing dependence on passive forms of treatment/care usually lead to optimal result. Often complete resolution of pain is not possible until the member begins to focus on increasing the number and kind of activities in which he/she participates.

• There is evidence for the effectiveness of SMT for the treatment of low back pain. • The strength of this evidence for SMT is generally as strong or stronger than for other

conservative or physical modalities that might be considered. • However, there is no evidence that SMT is the gold-standard intervention for any of the

conditions for which it is known to be effective. • As such, there are always alternate treatment options to consider for any member with

back pain and related disorders. • The safety profile of SMT, in regard to both mild and serious complications, is excellent

and likely superior to that of most standard medical interventions (e.g., NSAID therapy). • Disability-related back pain can rarely be attributed only to a specific physical injury or

pathology. Rather, disability is more correctly understood as a function of the interaction of a variety of factors, including physical/organic, psychological, social, economic, and secondary gain. This myriad should be considered when considering clinical interventions.

Clinical guidelines are to be considered in light of the clinical decision-making expertise of the clinical services manager and the individual case circumstance.



1 Cornerstones of ASHA Clinical Management 2

3 4 5 6 7 8 9

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Quality Improvement-focused Quality Management

• Systems planning and process improvements designed to meet the needs of dynamic internal and external expectations.

Clinical Quality Assurance and Clinical Improvement

• Real-time influence on the quality, clinical safety, and efficiency of delivery and the outcomes of member care.

“Available Evidence”-Based Decision Making**

• Effectively and efficiently manage, using clinical facts and knowledge derived from all available evidence.

Clinical Competency

• Competently provide clinical operations for corporation and clinical services to members through competent, disciplined practitioners.

**References Evidence-Based Medicine Working Group. (1992). Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA, 268, 2420-2425.

• An understanding and reliance on the original clinical scientific literature as the primary source of evidence

• An understanding of the rules of evidence in the evaluation of clinical scientific literature

• An understanding of the inherent limitations of experience, custom, and common sense as a guide to clinical effectiveness

• An understanding of the inherent limitations of basic science (in the absence of clinical science) as a guide to clinical effectiveness.

Sackett (2000) quoted in Institute of Medicine (2001), Crossing the Quality Chasm. National Academy Press.

“Evidence-based practice is the integration of best research evidence with clinical expertise and patient values. BEST RESEARCH EVIDENCE refers to clinically relevant research, often from the basic health and clinical (medical) sciences, but especially from patient centered clinical research into the accuracy and precision of diagnostic tests (including the clinical examination); the power of prognostic markers; the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. CLINICAL EXPERTISE means the ability to use clinical skills and past experience to rapidly identify each patient’s unique health state and diagnosis, individual risks and benefits of potential



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10 11 12 13 14 15 16 17 18 19 20

interventions, and personal values and expectations. PATIENT VALUES refers to the unique preferences, concerns, and expectations that each patient brings to a clinical encounter and that must be integrated into clinical decisions.” if they are to serve

How does evidence-based clinical decision-making work? Clinical decision-making is informed by both the basic and clinical sciences. Together, these two disciplines create a body of knowledge relative to the possible biological mechanisms, safety, efficacy, and effectiveness of a therapeutic intervention. This information will further provide insight into the validity, sensitivity, specificity, and reproducibility of specific diagnostic procedures. This knowledge is integrated with the physician’s patient care clinical experience. Integrated Health Care evidence (clinical science, basic science integrated with the knowledge and art of patient care) can then be applied to an individual patient's unique situation to ensure that the patient can be cared for in a way that enables an individualized care plan with a goal of reduced suffering, a rapid return to normal activities, decreased sequellae, and decreased clinical risk; thus reducing outcome variation of randomly attempted interventions selected solely on the basis of clinician bias and belief. See CPG UM 5 (Chiropractic) Selected List of References for additional references.


Clinician'spatient careexperience

andknowledge

Basic ScienceKnowledge

Clinical ScienceKnowledge

biological mechanisms;validity;

specificity;sensitivity

safety;efficacy;

effectiveness;reproducibility

"Doc"

Patient'sobjectiveevidence(clinical

findings) andpreferences

EB Clinical Decision

Intervention implemented

Objectivemonitoringof a valid,

measurableoutcome

Evidence Based

NON-Evidence Based

Clinician'spatient careexperience

bias andbeliefs


Documents

1 Policy: Manual Manipulation Therapy Clinical Decision ... · Manual Manipulation Therapy Clinical Decision-Assist Guideline Revised October 5, 2005 To CQT for review and recommendations