Evidenced Based Health Care within a Specialty Benefits Organization Steven M. Hilles, DC, CPHQ Director, Clinical Quality Management.

Evidenced Based Health Care within a Specialty Benefits OrganizationSteven M. Hilles, DC, CPHQDirector, Clinical Quality Management

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American Specialty Health

American Specialty HealthA full-service specialty benefits company for

complementary health care and health education programs.

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ASH Benefit Administration

Components• Credentialed, contracted providers• Utilization management• Claims administration• Member services• Provider services• Grievances and appeals • Quality management

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ASH Benefit Membership Distribution

12,219,590 members in 50 states and D.C. as of September 1, 2005.

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ASH Networks Providers

National networks*

14,121 chiropractors in 49 states and D.C.

2,834 acupuncturists in 40 states and D.C.

3,072 massage therapists in 47 states and D.C.

487 registered dietitians in 35 states and D.C.

223 naturopathic doctors in 7 states

7,620 affinity fitness clubs in 50 states and D.C.

632 benefit fitness clubs in 36 states

2,109 labs and x-ray facilities in 47 states and D.C.

31,098 providers and facilities in 50 states and D.C.

*Includes contracted providers and providers in the credentialing process as of November 22, 2005.

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ASH Networks Provider Distribution

*31,098 providers in 50 states and D.C. as of November 22, 2005.

National Networks*

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MCO’s Responsibilities

• ASH is a managed care company.

• We direct patients toward one set of practitioners (our network) and away from another set (everyone else)

• We are not passive with regard to the type and quality of care provided.

• We are doing more than simply insuring against financial loss by patient.

• Unlike academic science systematic review, we do not have the option of declaring there is “insufficient evidence” to make a decision

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Evidenced Based Health Care

EBHC is something that is applied to policies, guidelines, and other general applications of clinical science. The principles of EBHC are used by insurers, policy-makers, professional organizations, and guideline developers as well as by individual providers.

Following processes are undertaken in implementing EBHC:

1. A systematic review of all available evidence is undertaken.

2. A hierarchy of the evidence is established based on the type, quality, and relevance of the evidence.

3. Decision rules are established.

4. The decision rules are applied to the evidence to yield conclusions about the status of specific procedures and clinical processes.

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Evidenced Based Medicine

EBM provides a basis for reduced inappropriate variability in practice patterns by providers.

State Board Action-2003

“Testimonials stated that your patients received pain relief from sciatica by placing energy eggs in the patients socks for twenty minutes and became more energized by drinking water from energized mug. Another testimonial states that the patient improved by using an energy wand”

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credat emptor, “let the buyer have faith, Ashiatsu Oriental

Bar TherapyTM

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Question

Can the methods of biomedical science, as they are conventionally understood, appropriately be applied to the investigation and analysis of CHC systems and procedures?

Yes

Conclusion-Not all of technique, systems and procedures are all equally valid and appropriate. It must be possible to make distinctions among these systems and identify those that are of value to patients and those that are not.

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Goals

• Maximize patient health and safety

• Achieve provider acceptance

• Achieve health plan and employer acceptance

• Reflect best available scientific evidence

• Achieve consistency, transparency, and predictability

• Can be applied across disciplines

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Factors to Consider

• The science• Quality• Quantity

• The imprecision of clinical science

• State laws and regulations (licensing)

• Professionally recognized standards

• Practitioner beliefs and practices

• Patient preferences

• Market forces (health plan preferences)

Rules

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Rules

1. There should be no different scientific or clinical standard applied to CHC than as to conventional medical procedures.

2. Incorporate Clinical Evidence Hierarchy when evaluating the clinical literature. (Existence of effectiveness of a procedure)

3. In evaluating the effectiveness of a particular intervention or procedure, the contribution of Non-specific Treatment Effects (NSTE),” (placebo and nocebo effects) should be included in the analysis.

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Rules

4. Utilize the Bradford-Hill Criteria in evaluating the clinical literature, particularly when the published evidence is minimal or absent.

5. Develop a decision algorithm

6. Apply technique/procedures to the decision algorithm

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Definition of terms

• Acceptable- A procedure designated as acceptable must have existing evidence (as defined in this document) of diagnostic utility, or treatment effectiveness, as appropriate

• Unacceptable-A procedure designated as unacceptable does not have existing evidence of diagnostic utility, or scientific plausibility, or treatment effectiveness, as appropriate

• Contingent-A procedure designated as contingent either does not represent a “Best Practice” within a given profession or is a best practice but only in specified sub-populations of patients.

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Terms cont

• Safety-used only with specific reference to the presence or absence of direct harm.

• Direct harm. Any injury to a patient caused by the mechanical, thermal, biological, chemical, pharmacological, electrical, electromagnetic, or psycho-dynamic properties of a diagnostic or therapeutic procedure

• Indirect harm (substitution). Harm caused to a patient by substituting a specific diagnostic or therapeutic procedure whose safety, therapeutic effectiveness is unknown for a diagnostic or therapeutic procedure of known safety, effectiveness, or diagnostic

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Terms cont

• Labeling (Non-specific harm) Harm caused to a patient by the transmittal of false or misleading information that may cause emotional harm, a false sense of security

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Bradford Hill CriteriaBiological/Scientific Plausibility

• Does a particular intervention/procedure assume the existence of biological processes or other physical properties that are not known to exist?

• If so, it may be more reasonable to find alternate explanations for supposed effects.

• “Extraordinary claims require extraordinary proof.”• Some systems predicated upon improbable mechanisms

(meridian therapy, spinal manipulation) may also be understood in conventional terms.

• To say that a mechanism is unknown is not the same as saying that it is implausible.

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Technology Assessment

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Technology Assessment

• ASH’s clinical management team has established a Technology Assessment Clinical Consensus Committee (TACCC).

• The TACCC evaluates techniques and procedures used by contracted ASH providers and practitioners who apply for ASH Network participation.

• Members afforded the opportunity to provide any additional research

• 21 Participating providers participate on the TACCC• The TACCC meets twice a year

Technique/Procedure Assessment

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Surrogate Testing

• A variant of manual muscle testing techniques• The use of someone other than the patient to identify dysfunction

or illness• Used when age or illness prevents the patient from cooperating

with the testing procedures

Evidence and Research• There are no published studies on the diagnostic utility of this

procedure

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Surrogate Testing

QUESTION ANSWER

YES

YES

YES

NO

NO

Analysis performed on safety, effectiveness, diagnostic utility, and plausibility of procedure in clinical context?

Safety profile known?

Is procedure “Safe?”

Existence of effectiveness/utility data?

Scientifically plausible/coherent?

Path #1

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High Velocity Low Amplitude (HVLA)

• The therapeutic force or maneuver delivered by the practitioner during spinal manipulation

• A high velocity, low amplitude movement applied to a joint when all joint play has been removed

• Typically, HVLA results in joint cavitation and an audible release Evidence and Research• At least 80 randomized controlled trials (RCTs) on the

effectiveness of HVLA• There are >5 systematic reviews on HVLA effectiveness• This body of evidence supports HVLA as effective for low back

pain, neck pain, cervicogenic headache, tension headache, and migraine headache

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High Velocity Low Amplitude (HVLA)

QUESTION ANSWER

YES

YES

NO

YES

YES

YES

YES

Analysis performed on safety, effectiveness, diagnostic utility, and plausibility of procedure in clinical context?

Safety profile known?

Is procedure “Safe?”

Existence of effectiveness/utility data?

Is the preponderance of evidence positive?

Risk/benefit profile (appropriateness) known?

Favorable risk/benefit profile?

Path #14

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Accomplishments

• Developed a standardized process for evaluation of techniques/procedures-Decision Algorithm

• Established multispecialty committee (TACCC) • Committee has evaluated over 75 techniques/procedures

• Consensus opinions published on ashcompanies website

Visit:

www.ashcompanies.com

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ASH Companies