DEPARTMENT OF LABOR

Division of Industrial Affairs

Office of Workers’ Compensation

Statutory Authority: 19 Delaware Code, Section 2322B (19 Del.C. §2322B)

FINAL

ORDER

1341 Workers’ Compensation Regulations

A public hearing was held on May 12, 2008 to receive public comments relating to the Fee Schedule Rules and Instructions (“Rules and Instructions”), Drug Formulary (“Formulary”), Health Care Practice Guidelines (“Practice Guidelines”), and Utilization Review and Accompanying Form (“UR” and “UR Form”) for adoption by the Delaware Department of Labor. The members of the Health Care Advisory Panel (“Panel”) present recommend that the Secretary of Labor adopt this proposal as it was published in the Register of Regulations, Vol. 11, Issue 10 (April 1, 2008).

Summary of the Evidence and Information Submitted

Exhibits Admitted:

Exhibit 1 – News Journal Affidavit of publication of notice of public hearing.

Exhibit 2 – Delaware State News Affidavit of publication of notice of public hearing.

No written comments were received by the Delaware Department of Labor. After the Panel concluded with their introductions, personnel from Ingenix introduced themselves. Susan Seare, Ingenix Senior Director of Data Collection, stated for the record that she was available to assist with the data collection component of the Workers’ Compensation Act without charge.

The following comments were made during the Public Meeting:

Rules and Instructions:

First, Dennis Menton, Esquire addressed the Panel questioning the effective date of the Health Care Payment System and the Health Care Payment System’s effect on current/ongoing cases. Second, Scott Mondell, Esquire questioned when the Health Care Provider Certification information (list of certified providers) would be available to the public via the Delaware Department of Labor’s website.

Formulary:

Third, Dr. Frank Falco commented that the opiods, as listed on the Formulary, indicated an “inappropriate use.”

Practice Guidelines:

Fourth, Lorna Lee, an acupuncturist, recommended that the list of providers include professional acupuncturists. Further, Ms. Lee stated that House Bill No. 377, a bill currently before the House seeks to license and include acupuncturists in the list of Health Care providers. Dr. Falco also addressed the Panel on the issue of Practice Guidelines, first by complimenting the Panel on the work they had done in drafting the Practice Guidelines and next by discussing in detail areas where he believed the Practice Guidelines needed further revisions or modifications. Dr. Falco was asked by the Panel to provide his comments in writing so that they could be reviewed in detail at a later date. Dr. Falco did submit his written comments to John Kirk, Deputy Director of Industrial Affairs, the night of the Public Meeting and the following day. Mr. Menton, again addressed the Panel regarding the applicability of the Practice Guidelines and whether the statute’s effective date applied to cases already in the workers’ compensation system.

Utilization Review:

No public comment.

The Panel voted:

(1) 13 to 1 in favor of recommending approval of the Fee Schedule Rules and Instructions;

(2) unanimously to recommend approval of the Drug Formulary and the Health Care Practice Guidelines; and

(3) 12 to 2 in favor of recommending approval of Utilization Review and UR Form.

Therefore, the Panel agreed to submit and recommend the Fee Schedule Rules and Instruction, Drug Formulary, Health Care Practice Guidelines and Utilization Review and accompany form for adoption by the Delaware Department of Labor.

Recommended Findings of Fact with Respect to the Evidence and Information

The Panel is persuaded that the proposals are consistent with administrating the statutory directives in the new workers compensation law.

Recommendation

The proposals are respectfully submitted to the Secretary of Labor for consideration with a recommendation for adoption this 13th day of May, 2008.

HEALTH CARE ADVISORY PANEL
Bruce Rudin, M.D., Chair	George B. Heckler, Esquire, Vice-Chair
Wayne Smith	Linda Cho
Matthew Eppley, M.D.	Walter Powell, M.D.
Glenn Brown	Josette Covington, M.D.
Joseph Rhoades, Esquire	Barry Baskt, D.O.
Richard Hefron	Harry Gravell
Douglas Briggs, D.C.	James Downing, M.D.

Decision and Effective Date

Having reviewed and considered the record and recommendations of members of the Health Care Advisory Panel to adopt the Fee Schedule Rules and Instructions, Drug Formulary, Health Care Practice Guidelines, and Utilization Review and Accompanying Form. The Fee Schedule Rules and Instructions, Drug Formulary, Health Care Practice Guidelines, and Utilization Review and Accompanying Form are hereby adopted by the Delaware Department of Labor and made effective May 23, 2008.

Text and Citation

The Fee Schedule Rules and Instructions, Drug Formulary, Health Care Practice Guidelines, and Utilization Review and Accompanying Form notice appeared in the Register of Regulations, Vol. 11, Issue 10 (April 1, 2008). The Fee Schedule Rules and Instructions, Drug Formulary, Health Care Practice Guidelines, and Utilization Review and Accompanying Form are available from the Department of Labor, Division of Industrial Affairs, Office of Workers’ Compensation or on the department’s website: www.delawareworks.com.

DEPARTMENT OF LABOR

Thomas B. Sharp

Secretary of Labor

Health Care Payment System

1.0 Purpose and Scope

Section 2322B, Chapter 23, Section 19, Delaware Code, authorizes and directs the Health Care Advisory Panel to adopt and recommend, a coordinated set of instructions and guidelines to accompany the health care payment system, to the Department for adoption by regulation.

State of Delaware Workers' Compensation Act

Workers' Compensation Health Care Payment Rates for Physicians and Hospitals (the "Fee Schedule")

Instructions and Guidelines

Introduction and Purpose

The intent of the health care payment system developed pursuant to Delaware's Workers' Compensation Act ("Act") is not to establish a "pushdown" system, but is instead to establish a system that eliminates outlier charges and streamlines payments by creating a presumption of acceptability of charges implemented through a transparent process, involving relevant interested parties, that prospectively responds to the cost of maintaining a health care practice, eliminating cost shifting among health care service categories, and avoiding institutionalization of upward rate creep.

The maximum allowable payment for health care treatment and procedures covered under the Workers' Compensation Act shall be the lesser of the health care provider's actual charges or the fee set by the payment system. The payment system will set fees at ninety percent (90%) of the 75^th percentile of actual charges within the geozip where the service or treatment is rendered, utilizing information contained in employers' and insurance carriers' national databases. For purposes of the Act, "geozip" means an area defined by reference to United States ZIP Codes; Delaware shall consist of one "197 geozip" (comprised of all areas within the State where the address has a ZIP Code beginning with the three digits 197 or 198), and one "199 geozip" (comprised of all areas within the State where the address has a ZIP Code beginning with the three digits 199). If a geozip does not have the necessary number of charges and fees to calculate a valid percentile for a specific procedure, treatment or service, the Health Care Advisory Panel created pursuant to 19 Del.C. §2322(A), in its discretion may combine data from Delaware's two geozips for a specific procedure, treatment, or service. In the event that the Health Care Advisory Panel determines that there is insufficient data to calculate a valid percentile for a procedure, treatment or service, or that data from a commercial vendor is not sufficiently reliable to implement a payment system for professional services for a specific procedure, treatment or service, then the Health Care Advisory Panel may recommend an alternative method for a payment system for professional charges.

Three (3) years after the effective date of the Act, January 17, 2007, the Health Care Advisory panel shall review the geozip reporting system and make a recommendation concerning whether the State should operate its workers' compensation health care payment system on a geozip basis or on a single statewide basis.

If an employer or an insurance carrier contracts with a provider for the purpose of providing services under the Act, the rate negotiated in any such contract shall prevail.

This document is intended to assist with fee schedule application, and to ensure correct billing and reimbursement on workers' compensation medical claims. This document is NOT intended, and should not be construed, as a utilization review guide or practice manual.

Reference Materials

The health care payment system and fee schedule is in accordance with the following documents, including codes, guidelines and modifiers:

Current Procedural Terminology, copyright, American Medical Association, 515 N. State St., Chicago, IL 60610, Chicago, 2006;

HCPCS Level II, U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, 7500 Security Blvd., Baltimore, MD 21244, Baltimore, 2006;

National Correct Coding Policy Manual in Comprehensive Code Sequence for Part B Medicare Carriers, Version 12.0, U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, 7500 Security Blvd., Baltimore, MD 21244, Baltimore, 2006;

Relative Value Guide, copyright, American Society of Anesthesiologists, 520 N. Northwest Highway, Park Ridge, IL 60068-2573, Park Ridge, 2006;

Diagnosis-Related Group (DRG) classification system, Centers for Medicare and Medicaid Services (CMS), Federal Register, Vol. 70, No. 155, August 2005.

HCPCS (Healthcare Common Procedure Coding System) (Level II)

The health care payment system requires that services be reported with the Healthcare Common Procedural Coding System Level 2 ("HCPCS Level 2"), or CPT codes that most comprehensively describe the services performed. Proprietary bundling edits more restrictive than the National Correct Coding Policy Manual in Comprehensive Code Sequence for Part B Medicare Carriers, Version 12.0, U.S. Department of Health and Human Services, Centers for Medicare and Medicare Services, 7500 Security Boulevard, Baltimore, Maryland, 21244, 2006, no later dates or editions, shall be prohibited. Bundling edits is the process of reporting codes so that they most comprehensively describe the services performed.

Professional Services/CPT Code Set

Unless otherwise specified herein, the payment system for professional services shall conform to the Current Procedural Terminology ("CPT"), American Medical Association, 515 North State Street, Chicago, Illinois, 60610, 2006, no later dates or editions.

The fee schedule defers to guides and descriptions in the CPT Code Set in establishing the correct classification for health care services.

Physician/Health Care Provider Services

The maximum allowable payment for health care treatment and procedures shall be the lesser of the health care provider's actual charges or ninety percent (90%) of the 75^th percentile of actual charges within the geozip where the service or treatment is rendered, utilizing information contained in employers' and insurance carriers' national databases. If an employer or insurance carrier contracts with a provider for the purpose of providing services under the Act, the rate negotiated in such contract shall prevail.

Whenever the health care payment system does not set a specific fee for a procedure, treatment or service in the schedule, the amount of reimbursement shall be eighty-five percent (85%) of actual charge ("POC 85"), which actual charge will be fixed as of 11/1/08 and subsequent to such date will be subject to verification, audit and/or review by the Department of Insurance. Reasonable costs of such review or audit shall be reimbursed to the Department of Insurance by the health care provider whose billing is audited. From the effective date of this regulation through and including 10/31/08, the "POC 85" charges, if contested, will be subject to review pursuant to Hearing to be conducted before the Industrial Accident Board.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, based on percentage changes to the Consumer Price Index--Urban, U.S. City Average, All Items, as published by the United States Bureau of Labor Statistics.

Modifiers

Modifiers augment CPT codes to more accurately describe the circumstances of services provided. When applicable, the circumstances should be identified by a modifier code: a two-digit number placed after the usual procedure code. If more than one modifier is needed, place modifier 99 after the procedure code to indicate that two or more modifiers will follow. Some modifier descriptions in this fee schedule have been changed from the CPT language.

Anesthesia Services

The maximum allowable payment for anesthesia treatment, procedures or services shall be the lesser of the health care provider's actual charges or ninety percent (90%) of the 75^th percentile of actual charges within the geozip where the treatment, procedure or service is rendered, utilizing information contained in employers' and insurance carriers' national databases. If an employer or insurance carrier contracts with a provider for the purpose of providing services under the Act, the rate negotiated in such contract shall prevail.

Whenever the health care payment system does not set a specific fee for an anesthesia treatment, procedure or service in the schedule, the amount of reimbursement shall be eighty-five percent (85%) of actual charge ("POC 85") for such service as of October 31, 2006, subject to verification, review and/or audit by the Department of Insurance. Reasonable costs of such review or audit shall be reimbursed to the Department of Insurance by the health care provider whose billing is audited.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, and each year thereafter the Department of Labor shall make an automatic adjustment to the maximum payment for an anesthesia treatment, procedure and/or service in effect in January of that year. The Department of Labor shall increase or decrease the maximum payment by the percentage change of increase or decrease in the Consumer Price Index-Urban, U.S. City Average, All Items, as published in the United States Bureau of Labor Statistics.

Ambulatory Surgical Treatment

Fees billed for services provided to injured workers pursuant to the Act by an Ambulatory Surgical Treatment Center ("ASTC") shall be reimbursed at a rate equal to eighty-five percent (85%) of each ASTC's actual charges for services as of October 31, 2006. Verification that such billing is performed in compliance with 19 Del.C. §2322B(i)(1) shall be provided by each ASTC to the Office of Workers' Compensation within sixty (60) days of the completion and issuance of audited financial statements to the ASTC by its independent financial auditors. Such verification shall be subject to further review or audit by the Department of Insurance. Reasonable costs of such review or audit for purposes of the above-referenced section of the Act shall be reimbursed to the Department of Insurance by the ASTC whose billing is audited. The ASTC fee determination mechanism adopted pursuant to this subsection shall apply to all services provided after the effective date of the regulation implementing the fee schedule and regardless of the date of injury.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, and each year thereafter the Department of Labor shall make an automatic adjustment to each ASTC's reimbursement rates as derived pursuant to the above for procedures, treatments or services in effect in January of that year. The amount payable to each ASTC pursuant to the above shall be adjusted annually by the Department of Labor in accordance with the Consumer Price Index--Urban, U.S. City Average for Medical Care, as published by the United States Bureau of Labor Statistics. The adjustment factor referenced above shall be reviewed by the Health Care Advisory Panel three (3) years after the effective date of this section and the Panel shall make a recommendation concerning the continued use of the Consumer Price Index for Medical Care, or the adoption of a different index for cost adjustments in fees for ASTC services.

Dental Services

The maximum allowable payment for dental treatment, procedures or services shall be the lesser of the health care provider's actual charges of ninety percent (90%) of the 75^th percentile of actual charges within the geozip where the treatment, procedure or service is rendered, utilizing information contained in employers' and insurance carriers' national databases. If an employer or insurance carrier contracts with a provider for the purpose of providing services under the Act, the rate negotiated in such contract shall prevail.

Whenever the health care payment system does not set a specific fee for a dental treatment, procedure or service in the schedule, the amount of reimbursement shall be eighty-five percent (85%) of actual charge ("POC 85") for such service as of October 31, 2006, subject to verification, review and/or audit by the Department of Insurance. Reasonable costs of such review or audit shall be reimbursed to the Department of Insurance by the dental practitioner whose billing is audited.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, and each year thereafter the Department of Labor shall make an automatic adjustment to the maximum payment for a dental treatment, procedure or service in effect in January of that year. The Department of Labor shall increase or decrease the maximum payment by the percentage change of increase or decrease in the Consumer Price Index-Urban, U.S. City Average, All Items, as published by the United States Bureau of Labor Statistics.

Emergency Department of a Hospital

Services provided by an emergency department of a hospital, or any other facility subject to the Federal Emergency Medical Treatment and Active Labor Act, 42 United States Code §1395dd, et seq., and any emergency medical services provided in a pre-hospital setting by ambulance attendants and/or paramedics, shall be exempt from the healthcare payment system and shall not be subject to the requirement that a health care provider be certified pursuant to 19 Del.C. §2322D, requirements for preauthorization of services, or the health care practice guidelines adopted pursuant to 19 Del.C. §2322C.

Upon admission to a hospital and discharge from an emergency department, hospital charges shall be subject to that which is set forth in the section below titled "Hospital".

Hospital

Hospital fees billed for inpatient and outpatient services provided to injured workers pursuant to the Act shall be reimbursed at a rate equal to eighty-five percent (85%) of each hospital's actual charges for such services as of October 31, 2006, subject to adjustment as provided below. Verification that such billing is performed in compliance with the above and 19 Del.C. §2322B(h) shall be provided by each hospital to the Office of Workers' Compensation within sixty (60) days of the completion and issuance of audited financial statements to the hospital by its independent financial auditors. Such verification shall be subject to further review or audit by the Department of Insurance. Reasonable costs of such review or audit for purposes of this section shall be reimbursed to the Department of Insurance by the hospital whose billing is audited.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, with automatic adjustment to each hospital's reimbursement rates, as derived pursuant to 19 Del.C. §2322B(h), for procedures, treatments or services in effect in January of that year. The amount payable to each hospital pursuant to 19 Del.C. §2322B(h) shall be adjusted annually by the Department of Labor in accordance with the Consumer Price Index--Urban, U.S. City Average for Medical Care, as published by the United States Bureau of Labor Statistics. The adjustment factor referenced above shall be reviewed by the Health Care Advisory Panel three (3) years after the effective date of the regulation implementing the fee schedule, and the Panel shall make a recommendation concerning the continued use of the Consumer Price Index for medical care, or the adoption of a different index for cost adjustments in fees for hospital services.

Allied Health Care Professional

An allied health care professional, such as a certified registered nurse anesthetist ("CRNA"), physician assistant ("PA") or nurse practitioner ("NP"), shall be reimbursed at the same rate as other health care professionals when the allied health care professional is performing, coding and billing for the same services as other health care professionals if a physician health care provider is physically present when the service or treatment is rendered, and shall be reimbursed at eight percent (80%) of the primary health care provider's rate if a physician health care provider is not physically present when the service or treatment is rendered.

Independently Operated Diagnostic Testing Facility

Charges of an independently operated diagnostic testing facility shall be subject to the professional services and HCPCS Level II health care payment system where applicable. An independent diagnostic testing facility is an entity independent of a hospital or physician's office, whether a fixed location, a mobile entity, or an individual non-physician practitioner, in which diagnostic tests are performed by licensed or certified non-physician personnel under appropriate physician supervision.

In the event that the professional services and HCPCS Level II health care payment system is inapplicable, the fee for reimbursement of independent diagnostic testing facility services shall be eight-five percent (85%) of actual charge ("POC 85") for such service as of October 31, 2006, subject to verification, review and/or audit by the Department of Insurance. Reasonable costs of such review or audit shall be reimbursed to the Department of Insurance by the health care provider whose billing is audited.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, and each year thereafter the Department of Labor shall make an automatic adjustment to the maximum payment for a procedure, treatment or service in effect in January of that year. The Department of Labor shall increase or decrease the maximum payment by the percentage change of increase or decrease in the Consumer Price Index--Urban, U.S. City Average, All Items, as published by the United States Bureau of Labor Statistics.

Pathology

The maximum allowable payment for pathology services and procedures shall be the lesser of the health care provider's actual charges or ninety percent (90%) of the 75^th percentile of actual charges within the geozip where the pathology service or procedure is rendered, utilizing information contained in employers' and insurance carriers' national databases. If an employer or insurance carrier contracts with a provider for the purpose of providing services under the Act, the rate negotiated in such contract shall prevail.

Whenever the health care payment system does not set forth a specific fee for a pathology service or procedure in the schedule, the amount of reimbursement shall be eighty-five percent (85%) of actual charge ("POC 85") for such service or procedure as of October 31, 2006, subject to verification, review and/or audit by the Department of Insurance. Reasonable costs of such review or audit shall be reimbursed to the Department of Insurance by the health care provider whose billing is audited.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, and each year thereafter the Department of Labor shall make an automatic adjustment to the maximum payment for a procedure, treatment or service in effect in January of that year. The Department of Labor shall increase or decrease the maximum payment by the percentage change of increase or decrease in the Consumer Price Index--Urban, U.S. City Average, All Items, as published by the United States Bureau of Labor Statistics.

Radiology

The maximum allowable payment for radiology treatment, procedures or services shall be the lesser of the health care provider's actual charges or ninety percent (90%) of the 75^th percentile of actual charges within the geozip where the service or treatment is rendered, utilizing information contained in the employers' and insurance carriers' national databases. If an employer or insurance carrier contracts with a provider for the purpose of providing services under the Act, the rate negotiated in such contract shall prevail.

Whenever the health care payment system does not set forth a specific fee for a radiology treatment, procedure or service in the schedule, the amount for reimburse-ment shall be eighty-five percent (85%) of actual charge ("POC 85") for such service as of October 31, 2006, subject to verification, review and/or audit by the Department of Insurance. Reasonable costs of such review or audit shall be reimbursed to the Department of Insurance by the health care provider whose billing is audited.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, and each year thereafter the Department of Labor shall make an automatic adjustment to the maximum payment for a procedure, treatment or service in effect in January of that year. The Department of Labor shall increase or decrease the maximum payment by the percentage change of increase or decrease in the Consumer Price Index--Urban, U.S. City Average, All Items, as published by the United States Bureau of Labor Statistics.

Pharmacy

Reimbursement for pharmacy services, prescription drugs and other pharmaceuticals is 100% of the Average Wholesale Price (AWP) as of October 31, 2006. Verification that such billing is performed in compliance with the above and 19 Del.C. §2322B is subject to review or audit by the Department of Insurance. Reasonable costs of such review or audit for purposes of the above shall be reimbursed to the Department of Insurance by the provided whose billing is audited.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, and each year thereafter the Department of Labor shall make an automatic adjustment to the maximum payment for pharmacy services, prescription drugs and other pharmaceuticals in effect in January of that year. The Department of Labor shall increase or decrease the maximum payment by the percentage change of increase or decrease in the Consumer Price Index--Urban, U.S. City Average, All Items, as published by the United States Bureau of Labor Statistics.

A prescription drug formulary has been adopted and recommended by the Health Care Advisory Panel which designates preferred prescription drugs and encourages the use of generic drugs over name brand drugs.

Durable Medical Equipment

The maximum allowable payment for durable medical equipment shall be the lesser of the health care provider's actual charges or ninety percent (90%) of the 75^th percentile of actual charges within the geozip where the durable medical equipment is provided, utilizing information contained in employers' and insurance carriers' national databases. If an employer or insurance carrier contracts with a provider for the purpose of providing durable medical equipment under the Act, the rate negotiated in such contract shall prevail.

Whenever the health care payment system does not set a specific fee for durable medical equipment in the schedule, the amount of reimbursement shall be eighty-five percent (85%) of the provider's actual charge for such equipment as of October 31, 2006, subject to adjustment as provided below. Verification that such billing is performed in compliance with 19 Del.C. §2322B(h) shall be subject to verification, review and/or audit by the Department of Insurance. Reasonable costs of such review or audit for purposes of the above and 19 Del.C. §2322B shall be reimbursed to the Department of Insurance by the provider whose billing is audited.

The payment system will be adjusted yearly from the date the Health Care Advisory Panel recommended adoption of the fee schedule, November 14, 2007, and each year thereafter the Department of Labor shall make an automatic adjustment to the maximum payment for durable medical equipment in effect in January of that year. The Department of Labor shall increase or decrease the maximum payment by the percentage change of increase or decrease in the Consumer Price Index--Urban, U.S. City Average, All Items, as published by the United States Bureau of Labor Statistics.

Total Component/Professional Component, Technical Component

A total fee includes both the professional component and the technical component needed to accomplish the procedure. Explanations of the professional component and the technical component are listed below. The values listed in the Amount column represent the total reimbursement. Under no circumstance shall the combined amounts of the professional and technical components exceed the amount of the total component.

Professional Component: The professional component represents the reimbursement allowance of the professional services of the physician and is identified by the use of modifier 26. This includes examination of the patient when indicated, performance or supervision of the procedure, interpretation and written report of the examination, and consultation with the referring physician. Values in the PC Amount column are intended for the services of the professional for the professional component only and do not include any other charges. To identify a charge for a professional component only, use the five-digit code followed by modifier 26.

Technical Component: The technical component includes charges made by the institution or clinic to cover the services of the facilities. To identify a charge for a technical component only, use of the five-digit code followed by HCPCS Level II modifier TC.

Out-Of-State Service

If any procedure, treatment or service is rendered outside of the State of Delaware, the amount of reimbursement shall be the greater of (1) the amount set forth in a workers' compensation health care payment system or fee schedule adopted by the state in which the procedure, treatment or service is rendered, if such a schedule has been adopted, or (2) the amount that would be authorized by the payment system adopted pursuant to Delaware's Workers' Compensation Act if the service or treatment were performed in the geozip where the injury occurred or where the employee was principally assigned. Charges for a procedure, treatment or service outside the State of Delaware shall be subject to the instructions, guidelines, and payment guides and policies in the health care payment system.

Billing and Payment for Health Care Services

Pursuant to 19 Del.C. §2322F, charges for medical evaluation, treatment and therapy, including all drugs, supplies, tests and associated chargeable items and events, shall be submitted to the employer or insurance carrier along with a bill or invoice for such charges, accompanied by records or notes, concerning the treatment or services submitted for payment, documenting the employee's condition and the appropriateness of the evaluation, treatment or therapy, with reference to the health care practice guidelines adopted pursuant to 19 Del.C. §2322C, or documenting the preauthorization of such evaluation, treatment or therapy. The initial copy of the supporting notes or records shall be produced without separate or additional charge to the employer, insurance carrier or employee.

Those healthcare providers who obtained certification pursuant to 19 Del.C. §2322D are not required to first preauthorize each health care procedure, office visit or health care service to be provided to an injured employee with the employer or insurance carrier.

Charges for hospital services and items supplied by a hospital, including all drugs, supplies, tests and associated chargeable items and events, shall be submitted to the employer or insurance carrier along with a bill or invoice which shall be documented in a nationally recognized uniform billing code format and as reference above, in sufficient detail to document the services or items provided, and any preauthorization of the services and items shall also be documented. The initial copy of the supporting medical notes or records shall be produced without separate or additional charge to the employer, insurance carrier or employee.

Payment for hospital services, including payment for invoices rendered for emergency department services, shall be made within thirty (30) days of the submission of a "clean claim" accompanied by notes documenting the employee's condition and the appropriateness of the evaluation, treatment or therapy.

Preauthorized evaluations, treatments or therapy shall be paid at the agreed fee within thirty (30) days of the date of submission of the invoice, unless the compliance with the preauthorization is contested, in good faith, pursuant to the utilization review system set forth in 19 Del.C. §2322F(j) [see the rules and regulation regarding Utilization Review].

Treatments, evaluations and therapy provided by a certified health care provider shall be paid within thirty (30) days of receipt of the health care provider's bill or invoice together with records or notes as provided above and pursuant to 19 Del.C. §2322F, unless compliance with the health care payment system or practice guidelines adopted pursuant to 19 Del.C. §§2322B or 2322C is contested, in good faith, pursuant to the utilization review system as referenced above.

Denial of payment of health care services provided pursuant to the Act, whether in whole or in part, shall be accompanied with written explanation for reason for denial.

In the event that a portion of a health care invoice is contested, the uncontested portion shall be paid without prejudice to the right to contest the remainder. The time limits set forth above and in §2322F shall apply to payment of all uncontested portions of health care payments.

An employer or insurance carrier shall be required to pay a health care invoice within thirty (30) days of receipt of the invoice as long as the claim contains substantially all the required data elements necessary to adjudicate the invoice, unless the invoice is contested in good faith. If the contested invoice pertains to an acknowledged compensable claim and the denial is based upon compliance with the health care payment system and/or health care practice guidelines, it shall be referred to utilization review. Unpaid invoices shall incur interest at a rate of one percent (1%) per month payable to the provider. A provider shall not hold an employee liable for costs related to non-disputed services for a compensable injury and shall not bill or attempt to recover from the employee the difference between the provider's charge and the amount paid by the employer or insurance carrier on a compensable injury.

If, following a hearing, the Industrial Accident Board determines that an employer, an insurance carrier, or health care provider failed in its responsibilities under 19 Del.C. §§2322B, 2322C, 2322D, 2322E or 2322F, it shall assess a fine of not less than $1,000.00 nor more than $5,000.00 for violations of said sections, such fines shall be payable to the Workers' Compensation Fund.

Fees for Non-Clinical Services

Pursuant to 19 Del.C. §2322B(m), fees for certain non-clinical services are set as follows, and will be periodically revised upon recommendation of the Health Care Advisory Panel to reflect changes in the cost of providing such services:

1. Retrieving, copying and transmitting existing medical reports and records, to include copying of medical notes and/or records supporting a bill or invoice for charges for treatment or services:

$25.00 for search and retrieval

$1.25 per page for first 20 pages

$.90 per page for pages 21 through 60

$.30 per page for pages 61 and thereafter

2. Testimony by a physician for non-video deposition shall not exceed $2,000.00; for video deposition: $500.00 additional;

3. Live testimony by a physician at any hearing or proceeding shall not exceed $3,500.00;

4. Completion and transmission of any Statutorily required report, form or document by a physician/health care provider: $30.00.

Effective Date

The health care payment system shall apply to all services provided after the effective date of the health care payment system regulations and regardless of date of injury.

The Department of Labor of the State of Delaware reserves the authority to determine applicability of all rules of the fee schedule. Any physician, other medical professional, or other entity having questions regarding applicability to their individual reimbursement as it applies to the fee schedule, should direct any such question to the Department of Labor or to such other authority as directed by the Department of Labor.

DOWC PREFERRED DRUG LIST
Use the formulary below only for NSAID analgesics, opiod analagesics, skeletal muscle relaxants. Physicians are encouraged to prescribe generic drugs. If the physician feels it is medically necessary to prescribe a non-preferred drug and there is no generic equivalent then it can be done without prior authorization. Please note that the Reference Trade Name listed below is used only as an example of the generic drug. The use of sustained release/controlled release medication may be used when a continuous around-the-clock analgesic is needed for moderate to severe pain requiring treatment for an extended period of time.
ANALGESICS: NSAIDs
PREFERRED DRUG	Reference Trade Name
DICLOFENAC POTASSIUM 50MG TABLET ORAL	CATAFLAM 50 MG TABLET
DICLOFENAC SODIUM 100MG TAB.SR 24H ORAL	VOLTAREN-XR 100 MG TABLET
DICLOFENAC SODIUM 25MG TABLET DR ORAL	VOLTAREN 25 MG TABLET EC
DICLOFENAC SODIUM 50MG TABLET DR ORAL	VOLTAREN 50 MG TABLET EC
DICLOFENAC SODIUM 75MG TABLET DR ORAL	VOLTAREN 75 MG TABLET EC
DIFLUNISAL 250MG TABLET ORAL	DOLOBID 250MG TABLET
DIFLUNISAL 500MG TABLET ORAL	DOLOBID 500 MG TABLET
ETODOLAC 200MG CAPSULE ORAL	LODINE 200 MG CAPSULE
ETODOLAC 300MG CAPSULE ORAL	LODINE 300 MG CAPSULE
ETODOLAC 400MG TAB.SR 24H ORAL	LODINE XL 400MG TABLET SA
ETODOLAC 400MG TABLET ORAL	LODINE 400 MG TABLET
ETODOLAC 500MG TAB.SR 24H ORAL	LODINE XL 500 MG TABLET SA
ETODOLAC 500MG TABLET ORAL	LODINE 500MG TABLET
ETODOLAC 600MG TAB.SR 24H ORAL	LODINE XL 600MG TABLET SA
FENOPROFEN CALCIUM 200MG CAPSULE ORAL	NALFON 200 MG PULVULE
FENOPROFEN CALCIUM 300MG CAPSULE ORAL	NALFON 300 MG CAPSULE
FENOPROFEN CALCIUM 600MG TABLET ORAL	NALFON 600MG TABLET
FLURBIPROFEN 100MG TABLET ORAL	ANSAID 100 MG TABLET
FLURBIPROFEN 50MG TABLET ORAL	ANSAID 50MG TABLET
IBUPROFEN 100MG TAB CHEW ORAL	ADVIL 100 MG TABLET CHEW
IBUPROFEN 100MG TABLET ORAL	MOTRIN 100MG CAPLET
IBUPROFEN 100MG/5ML GEL ORAL	ELIXSURE IB SUSPENSION
IBUPROFEN 100MG/5ML ORAL SUSP ORAL	MOTRIN 100 MG/5 ML SUSPENSION
IBUPROFEN 200MG CAPSULE ORAL	ADVIL MIGRAINE 200 MG CAPSULE
IBUPROFEN 200MG TABLET ORAL	MOTRIN IB 200 MG CAPLET
IBUPROFEN 300MG TABLET ORAL	MOTRIN 300 MG TABLET
IBUPROFEN 400MG TABLET ORAL	MOTRIN 400 MG TABLET
IBUPROFEN 40MG/ML DROPS SUSP ORAL	MOTRIN 40MG/ML SUSP DROPS
IBUPROFEN 50MG TAB CHEW ORAL	MOTRIN 50MG TABLET CHEWABLE
IBUPROFEN 600MG TABLET ORAL	MOTRIN 600 MG TABLET
IBUPROFEN 800MG TABLET ORAL	MOTRIN 800 MG TABLET
INDOMETHACIN 25MG CAPSULE ORAL	INDOCIN 25MG CAPSULE
INDOMETHACIN 25MG/5ML ORAL SUSP ORAL	INDOCIN 25 MG/5 ML SUSPENSION
INDOMETHACIN 50MG CAPSULE ORAL	INDOCIN 50MG CAPSULE
INDOMETHACIN 50MG RECTAL SUPPOSITORY	INDOCIN 50 MG SUPPOSITORY
INDOMETHACIN 75MG CAPSULE SA ORAL	INDOCIN SR 75MG CAPSULE SA
KETOPROFEN 100MG PELLETED 24HR CAPSULE ORAL	ORUVAIL 100MG CAPSULE SA
KETOPROFEN 12.5MG TABLET ORAL	ORUDIS KT 12.5 MG TABLET
KETOPROFEN 150MG PELLETED 24HR CAPSULE ORAL	ORUVAIL 150MG CAPSULE SA
KETOPROFEN 200MG PELLETED 24HR CAPSULE ORAL	ORUVAIL 200 MG CAPSULE SA
KETOPROFEN 25MG CAPSULE ORAL	ORUDIS 25MG CAPSULE
KETOPROFEN 50MG CAPSULE ORAL	ORUDIS 50MG CAPSULE
KETOPROFEN 75MG CAPSULE ORAL	ORUDIS 75MG CAPSULE
KETOROLAC TROMETHAMINE 10MG TABLET ORAL	TORADOL 10 MG TABLET
MECLOFENAMATE SODIUM 100MG CAPSULE ORAL	MECLOMEN 100MG CAPSULE
MECLOFENAMATE SODIUM 50MG CAPSULE ORAL	MECLOMEN 50MG CAPSULE
NABUMETONE 500MG TABLET ORAL	RELAFEN 500 MG TABLET
NABUMETONE 750MG TABLET ORAL	RELAFEN 750 MG TABLET
NAPROXEN 125MG/5ML ORAL SUSP ORAL	NAPROSYN 125 MG/5 ML SUSPENSION
NAPROXEN 250MG TABLET ORAL	NAPROSYN 250 MG TABLET
NAPROXEN 375MG TABLET DELAYED-RELEASE ORAL	EC-NAPROSYN 375 MG TABLET
NAPROXEN 375MG TABLET ORAL	NAPROSYN 375 MG TABLET
NAPROXEN 500MG TABLET DELAYED-RELEASE ORAL	EC-NAPROSYN 500 MG TABLET
NAPROXEN 500MG TABLET ORAL	NAPROSYN 500 MG TABLET
NAPROXEN SODIUM 220MG TABLET ORAL	ALEVE 220 MG TABLET
NAPROXEN SODIUM 275MG TABLET ORAL	ANAPROX 275 MG TABLET
NAPROXEN SODIUM 550MG TABLET ORAL	ANAPROX DS 550 MG TABLET
NAPROXEN SODIUM 550MG TABLET SA ORAL	NAPRELAN 500 TABLET SA
OXAPROZIN 600MG TABLET ORAL	DAYPRO 600 MG CAPLET
PIROXICAM 10MG CAPSULE ORAL	FELDENE 10 MG CAPSULE
PIROXICAM 20MG CAPSULE ORAL	FELDENE 20MG CAPSULE
PREDNISONE TAB5 MG	STERAPRED 5MG UNIPACK
PREDNISONE TAB10 MG	STERAPRED DS UNIPACK
SALSALATE 500MG, 750MG CAPSULE/TABLET	DISALCID CAPSULE/TABLET
SULINDAC 150MG TABLET ORAL	CLINORIL 150MG TABLET
SULINDAC 200MG TABLET ORAL	CLINORIL 200 MG TABLET
TOLMETIN SODIUM 200MG TABLET ORAL	TOLECTIN 200MG TABLET
TOLMETIN SODIUM 400MG CAPSULE ORAL	TOLECTIN DS 400MG CAPSULE
TOLMETIN SODIUM 600MG TABLET ORAL	TOLECTIN 600MG TABLET
SKELETAL MUSCLE RELAXANTS
PREFERRED DRUG	Reference Trade Name
BACLOFEN 10MG TABLET ORAL	LIORESAL 10MG TABLET
BACLOFEN 20MG TABLET ORAL	LIORESAL 20MG TABLET
CHLORZOXAZONE 250MG TABLET ORAL	REMULAR-S 250MG TABLET
CHLORZOXAZONE 500MG TABLET ORAL	PARAFON FORTE DSC 500MG CAPSULE
CYCLOBENZAPRINE HCL 10MG TABLET ORAL	FLEXERIL 10 MG TABLET
DIAZEPAM 5 MG TABLET ORAL	VALIMUM 5 MG TABLET
METHOCARBAMOL 500MG TABLET ORAL	ROBAXIN 500 MG TABLET
METHOCARBAMOL 750MG TABLET ORAL	ROBAXIN-750 TABLET
METHOCARBAMOL/ASPIRIN 400-325MG TABLET ORAL	ROBAXISAL TABLET
ORPHENADRINE CITRATE 100MG TABLET SA ORAL	NORFLEX 100 MG TABLET SA
ORPHENADRINE/ASPIRIN/CAFFEINE 25-385-30 TABLET ORAL	NORGESIC TABLET
ORPHENADRINE/ASPIRIN/CAFFEINE 50-770-60 TABLET ORAL	NORGESIC FORTE TABLET
TIZANIDINE HCL 2MG TABLET ORAL	ZANAFLEX 2 MG TABLET
TIZANIDINE HCL 4MG TABLET ORAL	ZANAFLEX 4 MG TABLET
OPOID ANALGESICS
PREFERRED DRUG	Reference Trade Name
BUTORPHANOL TARTRATE 10MG/ML SPRAY NASAL	STADOL NS 10MG/ML SPRAY
CODEINE PHOS 15MG/5ML SOLUTION ORAL	N/A
CODEINE PHOS 30MG TABLET SOL ORAL	N/A
CODEINE PHOS 60MG TABLET SOL ORAL	N/A
CODEINE PHOS/ACETAMINOPHEN 12-120MG/5 ELIXIR ORAL	TYLENOL W/CODEINE ELIXIR
CODEINE PHOS/ACETAMINOPHEN 12-120MG/5 ORAL SUSP ORAL	CAPITAL W/CODEINE ORAL SUSPENSION
CODEINE PHOS/ACETAMINOPHEN 15-300MG TABLET ORAL	TYLENOL W/CODEINE #2 TABLET
CODEINE PHOS/ACETAMINOPHEN 30-300MG TABLET ORAL	TYLENOL W/CODEINE #3 TABLET
CODEINE PHOS/ACETAMINOPHEN 30-650MG TABLET ORAL	PHENAPHEN-650 W/CODEINE TABLET
CODEINE PHOS/ACETAMINOPHEN 60-300MG TABLET ORAL	TYLENOL W/CODEINE #4 TABLET
CODEINE PHOS/ASPIRIN 30-325MG TABLET ORAL	EMPIRIN W/CODEINE 30MG TABLET
CODEINE PHOS/ASPIRIN 60-325MG TABLET ORAL	EMPIRIN W/CODEINE 60MG TABLET
CODEINE SULF 15MG TABLET ORAL	N/A
CODEINE SULF 30MG TABLET ORAL	N/A
CODEINE SULF 60MG TABLET ORAL	N/A
CODEINE/APAP/CAFFEIN/BUTALB 30MG CAPSULE ORAL	FIORICET W/CODEINE CAPSULE
CODEINE/ASA/CAFFEINE/BUTALB 30MG CAPSULE ORAL	FIORINAL/CODEINE #3 CAPSULE
HYDROCODONE BIT/ACETAMINOPHEN 10-250MG TABLET ORAL	STAGESIC-10 CAPLET
HYDROCODONE BIT/ACETAMINOPHEN 10-325MG TABLET ORAL	NORCO 10/325 TABLET
HYDROCODONE BIT/ACETAMINOPHEN 10-500MG TABLET ORAL	LORTAB 10/500 TABLET
HYDROCODONE BIT/ACETAMINOPHEN 10-650MG TABLET ORAL	LORCET 10/650 TABLET
HYDROCODONE BIT/ACETAMINOPHEN 10-660MG TABLET ORAL	VICODIN HP TABLET
HYDROCODONE BIT/ACETAMINOPHEN 10-750MG TABLET ORAL	MAXIDONE 10/750 MG TABLET
HYDROCODONE BIT/ACETAMINOPHEN 2.5-167/5 ELIXIR ORAL	LORTAB ELIXIR
HYDROCODONE BIT/ACETAMINOPHEN 2.5-167/5 SOLUTION ORAL	N/A
HYDROCODONE BIT/ACETAMINOPHEN 2.5-500MG TABLET ORAL	LORTAB 2.5/500 TABLET
HYDROCODONE BIT/ACETAMINOPHEN 5-325MG TABLET ORAL	NORCO 5/325 TABLET
HYDROCODONE BIT/ACETAMINOPHEN 5-500MG CAPSULE ORAL	LORCET HD CAPSULE
HYDROCODONE BIT/ACETAMINOPHEN 5-500MG TABLET ORAL	VICODIN 5/500 TABLET
HYDROCODONE BIT/ACETAMINOPHEN 7.5-325MG TABLET ORAL	NORCO 7.5/325 TABLET
HYDROCODONE BIT/ACETAMINOPHEN 7.5-500MG TABLET ORAL	LORTAB 7.5/500 TABLET
HYDROCODONE BIT/ACETAMINOPHEN 7.5-650MG TABLET ORAL	LORCET PLUS TABLET
HYDROCODONE BIT/ACETAMINOPHEN 7.5-750MG TABLET ORAL	VICODIN ES TABLET
HYDROCODONE BIT/ASPIRIN 5-500MG TABLET ORAL	LORTAB ASA TABLET
HYDROMORPHONE HCL 1MG/ML LIQUID ORAL	DILAUDID-5 1 MG/ML LIQUID
HYDROMORPHONE HCL 2MG TABLET ORAL	DILAUDID 2 MG TABLET
HYDROMORPHONE HCL 4MG TABLET ORAL	DILAUDID 4 MG TABLET
HYDROMORPHONE HCL 8MG TABLET ORAL	DILAUDID 8 MG TABLET
IBUPROFEN/HYDROCODONE BIT 200-7.5MG TABLET ORAL	VICOPROFEN TABLET
MEPERIDINE HCL 100MG TABLET ORAL	DEMEROL 100MG TABLET
MEPERIDINE HCL 50MG TABLET ORAL	DEMEROL 50 MG TABLET
MEPERIDINE HCL 50MG/5ML SYRUP ORAL	DEMEROL 50 MG/5 ML SYRUP
MEPERIDINE HCL/PROMETH HCL 50-25MG CAPSULE ORAL	MEPROZINE 50/25 CAPSULE
METHADONE HCL 10MG TABLET ORAL	DOLOPHINE HCL 10 MG TABLET
OPIOID ANALGESICS
PREFERRED DRUG	Reference Trade Name
METHADONE HCL 10MG/5ML SOLUTION ORAL	N/A
METHADONE HCL 10MG/ML ORAL CONC. ORAL	METHADOSE 10 MG/ML ORAL CON
METHADONE HCL 40MG TABLET SOL ORAL	METHADOSE 40 MG TABLET DISP
METHADONE HCL 5MG TABLET ORAL	DOLOPHINE HCL 5 MG TABLET
METHADONE HCL 5MG/5ML SOLUTION ORAL	N/A
MORPHINE SULFATE 10MG RECTAL SUPPOSITORY	ROXANOL 10MG SUPPOSITORY
MORPHINE SULFATE 10MG SOLUBLE TABLET	N/A
MORPHINE SULFATE 10MG/5ML SOLUTION ORAL	MSIR 10 MG/5 ML ORAL SOLUTION
MORPHINE SULFATE 15MG SOLUBLE TABLET	N/A
MORPHINE SULFATE 15MG TABLET ORAL	MSIR 15MG TABLET
MORPHINE SULFATE 20MG RECTAL SUPPOSITORY	ROXANOL 20MG SUPPOSITORY
MORPHINE SULFATE 20MG/5ML SOLUTION ORAL	MSIR 20 MG/5 ML ORAL SOLUTION
MORPHINE SULFATE 20MG/ML SOLUTION ORAL	ROXANOL 20 MG/ML SOLUTION
MORPHINE SULFATE 30MG RECTAL SUPPOSITORY	ROXANOL 30MG SUPPOSITORY
MORPHINE SULFATE 30MG SOLUBLE TABLET	N/A
MORPHINE SULFATE 30MG TABLET ORAL	MSIR 30MG TABLET
MORPHINE SULFATE 5MG RECTAL SUPPOSITORY	ROXANOL 5MG SUPPOSITORY
OXYCODONE HCL 15MG TABLET ORAL	ROXICODONE 15 MG TABLET
OXYCODONE HCL 20MG/ML ORAL CONC. ORAL	OXYFAST 20 MG/ML SOLUTION
OXYCODONE HCL 30MG TABLET ORAL	ROXICODONE 30 MG TABLET
OXYCODONE HCL 5MG CAPSULE ORAL	OXYIR 5 MG CAPSULE
OXYCODONE HCL 5MG TABLET ORAL	ROXICODONE 5 MG TABLET
OXYCODONE HCL 5MG/5ML SOLUTION ORAL	ROXICODONE 5 MG/5 ML SOLUTION
OXYCODONE HCL/ACETAMINOPHEN 10-325MG TABLET ORAL	PERCOCET 10/325 MG TABLET
OXYCODONE HCL/ACETAMINOPHEN 10-650MG TABLET ORAL	PERCOCET 10/650 MG TABLET
OXYCODONE HCL/ACETAMINOPHEN 2.5-325MG TABLET ORAL	PERCOCET 2.5/325 MG TABLET
OXYCODONE HCL/ACETAMINOPHEN 5-325/5ML SOLUTION ORAL	ROXICET 5/325 ORAL SOLUTION
OXYCODONE HCL/ACETAMINOPHEN 5-325MG TABLET ORAL	PERCOCET 5/325 MG TABLET
OXYCODONE HCL/ACETAMINOPHEN 5-500MG CAPSULE ORAL	TYLOX 5/500 CAPSULE
OXYCODONE HCL/ACETAMINOPHEN 7.5-325MG TABLET ORAL	PERCOCET 7.5/325 MG TABLET
OXYCODONE HCL/ACETAMINOPHEN 7.5-500MG TABLET ORAL	PERCOCET 7.5/500 MG TABLET
OXYCODONE/ASPIRIN 4.88-325MG TABLET ORAL	PERCODAN TABLET
OXYMORPHONE HCL 5MG RECTAL SUPPOSITORY	NUMORPHAN 5 MG SUPPOSITORY
PENTAZOCINE/ACETAMINOPHEN CAPLET	TALACEN CAPLET
PENTAZOCINE/NALOXONE TABLET	TALWIN NX TABLET
PROPOXYPHENE HCL 65MG CAPSULE ORAL	DARVON 65 MG PULVULE
PROPOXYPHENE HCL/ACETAMINOPHEN 65-650MG TABLET ORAL	WYGESIC 65/650 TABLET
PROPOXYPHENE HCL/ASA/CAFFEINE 32-389-32 CAPSULE ORAL	DARVON COMPOUND-32 PULVULE
PROPOXYPHENE HCL/ASA/CAFFEINE 65-389 CAPSULE ORAL	DARVON COMPOUND-65 PULVULE
PROPOXYPHENE NAPSYL 100MG TABLET ORAL	DARVON-N 100 MG TABLET
PROPOXYPHENE/ACETAMINOPHEN 100-325MG TABLET ORAL	TRYCET 100/325 MG TABLET
PROPOXYPHENE/ACETAMINOPHEN 100-650MG TABLET ORAL	DARVOCET-N 100 TABLET
PROPOXYPHENE/ACETAMINOPHEN 50-325MG TABLET ORAL	DARVOCET-N 50 TABLET
TRAMADOL HCL 50MG TABLET ORAL	ULTRAM 50 MG TABLET
TRAMADOL HCL/ACETAMINOPHEN 37.5-325MG TABLET ORAL	ULTRACET TABLET
ADJUVANTS
PREFERRED DRUG	Reference Trade Name
AMITRIPTYLINE HCL 10MG, 25MG, 50MG, 75MG, 100MG	ELAVIL TABLETS
DESYREL TABLETS 50MG, 100MG	TAZADONE HCL
GABAPENTIN CAPSULES 100MG, 300MG, 400MG	NEURONTIN CAPSULES
NORTRIPTYLINE HCL CAPSULES 10MG, 25MG, 50MG, 75MG	PAMELOR CAPSULES

Utilization Review

1.0 Definitions

As used in this regulation:

“Utilization Review” means the utilization review program and associated procedures to guide utilization of health care treatments in workers’ compensation as set forth in Section 2322F(j), Chapter 23, Title 19, Delaware Code.

2.0 Purpose and Scope

Section 2322B, Chapter 23, Section 19, Delaware Code, authorizes and directs the Health Care Advisory Panel to adopt and recommend, a coordinated set of instructions and guidelines to accompany the health care payment system, to the Department for adoption by regulation.

3.0 Utilization Review

3.1 Pursuant to chapter 101, title 29 of the Delaware Code, the Department of Labor has developed a utilization review program with the intent of providing reference for employers, insurance carriers, and health care providers for evaluation of health care and charges. The intended purpose of utilization review services is to provide prompt resolution of issues related to treatment and/or compliance with the health care payment system or practice guidelines for those claims which have been acknowledged to be compensable.

3.2 An employer or insurance carrier may engage in utilization review to evaluate the quality, reasonableness and/or necessity of proposed or provided health care services for acknowledged compensable claims. Any person conducting a utilization review program for workers’ compensation shall be required to register with the Office of Workers’ Compensation once every two (2) years and certify compliance with Workers’ Compensation Utilization Management Standards or Health Utilization Management Standards of Utilization Review Accreditation Council (“URAC”) sufficient to achieve URAC accreditation or submit evidence of accreditation by URAC.

3.3 At this time, Utilization Review is limited to health care recommendations subject to practice guidelines developed by the HCAP.

3.4 An employer or insurance carrier may request utilization review by complying with all the terms and conditions set forth on the forms attached hereto. Upon completion and submission of the forms, information package and medical records package by the employer or insurance carrier, the designated utilization review company will review treatment to determine if it is in compliance with the practice guidelines developed by the Health Care Advisory Panel and adopted and implemented by the Department of Labor. All past, prospective and concurrent health care decisions must be reviewed and a Utilization Review determination made no later than three (3) working days from receipt of the aforementioned information, for emergency care, but no later than 15 calendar days from the date of the treatment recommended by the physician or less if set forth in URAC guidelines.

3.5 If a party disagrees with the findings following utilization review, a petition may be filed with the Industrial Accident Board for de novo review.

3.6 If there are no current practice guidelines applicable to the health care provided, a party may file a petition with the Industrial Accident Board seeking a determination of the appropriateness of treatment.

DELAWARE DEPARTMENT OF LABOR

MEDICAL UTILIZATION REVIEW PROGRAM

REQUEST FOR UTILIZATION REVIEW

(Pursuant to 19 Del.C. §2322 F(j))

PLEASE TYPE OR CLEARLY PRINT ALL INFORMATION. All information and addresses must be verified as current and accurate.

1. Date of Request _________________________

2. WC Number(s) _________________________ Date(s) of injury _________________________

3. Nature of injury _______________________________________________________________________

4. Claimant’s Name______________________________________________________________________

Age__________ Sex____________ Marital Status___________

Address _______________________________________________Tel No ______________________

City ____________________________________________________State _________ Zip ___________

Attorney’s Name_______________________________________________________________________

Address _________________________________________________Tel No ______________________

City______________________________________________________State ________ Zip ___________

5. Employer__________________________ Occupation_______________ Job Title__________________

6. Party Requesting Review_____________________________________________________________

Primary Contact at Party’s Office ________________________________________________________

Address________________________________________________Tel No ______________________

City ___________________________________________________ State ________ Zip____________

Attorney’s Name_____________________________________________________________________

Address ________________________________________________Tel No_____________________

City ___________________________________________________State ________ Zip ___________

7. Health Care Provider to be Reviewed__________________________________________________

Specialty (if applicable) _______________________________________________________________

Address________________________________________________Tel No_____________________

City___________________________________________________ State ________ Zip___________

8. Attach copies of all admissions and/or orders filed or entered in this case.

My signature certifies the following: a) all names and addresses on this form have been verified as current and accurate; b) seven identical copies of associated medical material are being submitted for review; and c) all items listed in the table of contents are in each copy of the medical material.

_____________________________________ _____________________________________

Print Name of Requester Signature of Requester

COPY THIS FORM OR REPRODUCE EXACTLY IN APPEARANCE AND CONTENT
SEE INSTRUCTIONS ON BACK

Rev. _______ 1 of 2

REQUIRED CONTENT, PRESENTATION AND BINDING METHOD

FOR ALL MATERIALS SUBMITTED FOR UTILIZATION REVIEW

In accordance with 19 Del.C. §2322 F(j) and the regulations adopted pursuant thereto, all information and medical records submitted to the Department of Labor, Office of Workers’ Compensation must represent all of the facts of this case.

INFORMATION PACKAGE - REQUIRED CONTENT

Completed and signed Request for Utilization Review Form.
A list containing the full names and medical specialties of all providers under review and individuals who

performed defense medical examinations relevant to the matter under review.

MEDICAL RECORDS PACKAGE - REQUIRED CONTENT

1. Case Report - The case report shall contain the following:

2. Table of Contents

NOTE Do not include copies of any billing statements or comments/instructions directed to the Utilization Review panel. All material must be presented in identified sections; each section’s content presented in chronological order.

REQUIRED PRESENTATION AND BINDING METHOD FOR ALL SUBMITTED MATERIALS

INFORMATION PACKAGE - SUBMIT ONE COPY ONLY -- staple in upper-left-hand corner.
MEDICAL RECORDS PACKAGE - SUBMIT SEVEN (7) COPIES
a. All submitted material must be presented in seven (7) identical bound copies.
b. If tabs are used for the sections, they must be positioned to the right side of the document.

Mail or Deliver to: Department of Labor

Office of Workers’ Compensation
4425 N. Market St.

P.O. Box 9954

Wilmington, DE 19809

302-761-8200

Rev. _______ 2 of 2

Health Care Practice Guidelines

Carpal Tunnel Syndrome Guidelines

A. Introduction

Pursuant to 19 Del.C. §2322C, health care practice guidelines have been adopted and recommended by the Health Care Advisory Panel to guide utilization of health care treatments in workers' compensation including, but not limited to, care provided for the treatment of employees by or under the supervision of a licensed health care provider, prescription drug utilization, inpatient hospitalization and length of stay, diagnostic testing, physical therapy, chiropractic care and palliative care. The health care practice guidelines apply to all treatments provided after the effective date of the regulation adopted by the Department of Labor, May 23, 2008, and regardless of the date of injury.

The guidelines are, to the extent permitted by the most current medical science or applicable science, based on well-documented scientific research concerning efficacious treatment for injuries and occupational disease. To the extent that well-documented scientific research regarding the above is not available at the time of adoption of the guidelines, or is not available at the time of any revision to the guidelines, the guidelines have been and will be based upon the best available information concerning national consensus regarding best health care practices in the relevant health care community.

The guidelines, to the extent practical and consistent with the Act, address treatment of those physical conditions which occur with the greatest frequency, or which require the most expensive treatments, for work-related injuries based upon currently available Delaware data.

Services rendered by any health care provider certified pursuant to 19 Del.C. §2322D(a) to provide treatment or services for injured employees shall be presumed, in the absence of contrary evidence, to be reasonable and necessary if such treatment and/or services conform to the most current version of the Delaware health care practice guidelines.

Services rendered outside the Guidelines and/or variation in treatment recommendations from the Guidelines may represent acceptable medical care, be considered reasonable and necessary treatment and, therefore, determined to be compensable, absent evidence to the contrary, and may be payable in accordance with the Fee Schedule and Statute, accordingly.

Services provided by any health care provider that is not certified pursuant to 19 Del.C. §2322D(a) shall not be presumed reasonable and necessary unless such services are pre-authorized by the employer or insurance carrier, subject to the exception set forth in 19 Del.C. §2322D(b).

Treatment of conditions unrelated to the injuries sustained in an industrial accident may be denied as unauthorized if the treatment is directed toward the non-industrial condition, unless the treatment of the unrelated injury is rendered necessary as a result of the industrial accident.

The Health Care Advisory Panel and Department of Labor recognized that acceptable medical practice may include deviations from these Guidelines, as individual cases dictate. Therefore, these Guidelines are not relevant as evidence of a provider's legal standard of professional care.

In accordance with the requirements of the Act, the development of the health care guidelines has been directed by a predominantly medical or other health professional panel, with recommendations then made to the Health Care Advisory Panel.

B. General Guideline Principles

The principles summarized in this section are key to the intended implementation of all Division of Workers’ Compensation guidelines and critical to the reader’s application of the guidelines in this document.

1. Education of the patient and family, as well as the employer, insurer, policy makers and the community should be the primary emphasis in the treatment of CTS and disability. Currently, practitioners often think of education last, after medications, manual therapy and surgery. Practitioners must develop and implement an effective strategy and skills to educate patients, employers, insurance systems, policy makers and the community as a whole. An education-based paradigm should always start with inexpensive communication providing reassuring information to the patient. More in-depth education currently exists within a treatment regime employing functional restorative and innovative programs of prevention and rehabilitation. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention.

2. Treatment Parameter time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Obviously, duration will be impacted by patient compliance, as well ascomorbitities and availability of services. Clinical judgment may substantiate the need to accelerate or deceleratemodify the time framestotal number of visits discussed in this document. The majority of injured workers with Carpal Tunnel Syndrome often will achieve resolution of their condition within 12 to 56 visits (Guide To Physical Therapy Practice – Second Edition). It is anticipated that most injured workers will not require the maximum number of visits described in these guidelines. They are designed to be a ceiling and care extending beyond the maximum allowed visits may warrant utilization review.

3. Active Interventions emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, are generally emphasized over passive modalities, especially as treatment progresses. Generally, passive interventions are viewed as a means to facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains. All rehabilitation programs must incorporate “Active Interventions” no later than three weeks after the onset of treatment. Reimbursement for passive modalities only after the first three weeks of treatment without clear evidence of Active Interventions will require supportive documentation.

4. Active Therapeutic Exercise Program Exercise program goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

5. Positive Patient Response Positive results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to, positional tolerances, range-of-motion, strength, endurance, activities of daily living, cognition, behavior, and efficiency/velocity measures that can be quantified. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation. Anatomic correlation must be based on objective findings.

6. Re-evaluate Treatment Every 3 To 4 Weeks If a given treatment or modality is not producing positive results within 3 to 4 weeks, the treatment should be either modified or discontinued. Reconsideration of diagnosis should also occur in the event of poor response to a seemingly rational intervention.

7. Surgical Interventions Surgery should be contemplated within the context of expected functional outcome and not purely for the purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic conditions.

8. Six-month Time-frame The prognosis drops precipitously for returning an injured worker to work once he/she has been temporarily totally disabled for more than six months. The emphasis within these guidelines is to move patients along a continuum of care and return-to-work within a six-month time frame, whenever possible. It is important to note that time frames may not be pertinent to injuries that do not involve work-time loss or are not occupationally related.

9. Return-to-work is therapeutic, assuming the work is not likely to aggravate the basic problem or increase long-term pain. The practitioner must provide specific physical limitations per the Physician’s Form. The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, data entry and other repetitive motion tasks, sustained grip, tool usage and vibration factors. Even if there is residual chronic pain, return-to-work is not necessarily contraindicated.

The practitioner should understand all of the physical demands of the patient’s job position before returning the patient to full duty and should receive clarification of the patient’s job duties.

10. Delayed Recovery Strongly consider a psychological evaluation, if not previously provided, as well as initiating interdisciplinary rehabilitation treatment and vocational goal setting, for those patients who are failing to make expected progress 6 to 12 weeks after an injury. The Division recognizes that 3 to 10% of all industrially injured patients will not recover within the timelines outlined in this document despite optimal care. Such individuals may require treatments beyond the limits discussed within this document, but such treatment will require clear documentation by the authorized treating practitioner focusing on objective functional gains afforded by further treatment and impact upon prognosis.

11. Guideline Recommendations and Inclusion of Medical Evidence Guidelines are recommendations based on available evidence and/or consensus recommendations.

Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guideline as being “not recommended.”

12. Care Beyond Maximum Medical Improvement (MMI) MMI should be declared when a patient’s condition has plateaued to the point where the authorized treating physician no longer believes further medical intervention is likely to result in improved function. However, some patients may require treatment after MMI has been declared in order to maintain their functional state. The recommendations in this guideline are for pre-MMI care and are not intended to limit post-MMI treatment.

The remainder of this document should be interpreted within the parameters of these guideline principles that may lead to more optimal medical and functional outcomes for injured workers.

C. Definition

Carpal tunnel syndrome (CTS) is one of the most common mononeuropathies (a disorder involving only a single nerve). The median nerve is extremely vulnerable to compression and injury in the region of the wrist and palm. In this area, the nerve is bounded by the wrist bones and the transverse carpal ligament. The most common site of compression is at the proximal edge of the flexor retinaculum (an area near the crease of the wrist). There is often a myofascial component in the patient's presentation. This should be considered when proceeding with the diagnostic workup and therapeutic intervention.

Studies have repeatedly confirmed that the diagnosis cannot be made based on any single historical factor or physical examination finding. Electrodiagnostic tests may be negative in surgically confirmed cases. Conversely, electrodiagnostic testing may be positive in asymptomatic individuals. The diagnosis of CTS, therefore, remains a clinical diagnosis based on a preponderance of supportive findings.

Classic findings of CTS include subjective numbness or dysesthesias confined to the median nerve distribution, worsening of symptoms at night, and positive exam findings. Please refer to other appropriate upper extremity guidelines as necessary.

D. Initial Diagnostic Procedures

1. Introduction The two standard procedures that are to be utilized when initially evaluating a work-related carpal tunnel complaint are History Taking, and Physical Examination.

History-taking and Physical Examination are generally accepted, well-established, and widely used procedures which establish the foundation/basis for and dictate all ensuing stages of diagnostic and therapeutic procedures. When findings of clinical evaluation and those of other diagnostic procedures do not complement each other, the objective clinical findings should have preference.

2. History

a. Description of symptoms - should address at least the following:

i. Numbness, tingling, and/or burning of the hand involving the distal median nerve distribution; however, distribution of the sensory symptoms may vary considerably between individuals. Although the classic median nerve distribution is to the palmar aspect of the thumb, the index finger, the middle finger and radial half of the ring finger, patients may report symptoms in any or all of the fingers. The Katz Hand diagram (see Fig. 1) may be useful in documenting the distribution of symptoms; the classic pattern of carpal tunnel affects at least two of the first three digits and does not involve dorsal and palmar aspects of the hand. A probable pattern involves the palmar but not dorsal aspect of the hand (excluding digits).

ii. Nocturnal symptoms frequently disrupt sleep and consist of paresthesias and/or pain in the hand and/or arm.

iii. Pain in the wrist occurs frequently and may even occur in the forearm, elbow or shoulder. While proximal pain is not uncommon, its presence warrants evaluation for other pathology in the cervical spine, shoulder and upper extremity.

iv. Shaking the symptomatic hand to relieve symptoms may be reported.

v. Clumsiness of the hand or dropping objects is often reported, but may not be present early in the course.

Figure 1 – Katz Hand Diagram. Used with permission. JAMA 2000; 283 (23): 3110-17. Copyrighted 2000, American Medical Association

b. Identification of Occupational Risk Factors: Job title alone is not sufficient information. The clinician is responsible for documenting specific information regarding repetition, force and other risk factors, as listed in the table entitled, ‘Risk Factors Associated with CTS’- Table 2. A job site evaluation may be required.

c. Demographics: Age, hand dominance, gender, etc.

d. Past Medical History and Review of Systems: A study of CTS patients showed a 33% prevalence of related disease. Risk factors for CTS include female gender; obesity; Native American, Hispanic, or Black heritage, and certain medical conditions:

i. Pregnancy

ii. Arthropathies including connective tissue disorders, rheumatoid arthritis, systemic lupus erythematosus, gout, osteoarthritis and spondyloarthropathy

iii. Colles’ fracture or other acute trauma

iv. Amyloidosis

v. Hypothyroidism, especially in older females

vi. Diabetes mellitus, including family history or gestational diabetes

vii. Acromegaly

viii. Use of corticosteroids or estrogens

ix. Vitamin B6 deficiency

e. Activities of Daily Living (ADLs): include such activities as self care and personal hygiene, communication, ambulation, attaining all normal living postures, travel, non-specialized hand activities, sexual function, sleep, and social and recreational activities. Specific movements in this category include pinching or grasping keys/pens/other small objects, grasping telephone receivers or cups or other similar-sized objects, and opening jars. The quality of these activities is judged by their independence, appropriateness, and effectiveness. Assess not simply the number of restricted activities but the overall degree of restriction or combination of restrictions.

f. Avocational Activities: Information must be obtained regarding sports, recreational, and other avocational activities that might contribute to or be impacted by CTD development. Activities such as hand-operated video games, crocheting/needlepoint, home computer operation, golf, racquet sports, bowling, and gardening are included in this category.

g. Social History: Exercise habits, alcohol consumption, and psychosocial factors.

3. Physical Examination Please refer to Table 1 for respective sensitivities and specificities for findings used to diagnose CTS (a-f).

a. Sensory loss to pinprick, light touch, two-point discrimination or Semmes-Weinstein Monofilament tests in a median nerve distribution may occur

b. Thenar atrophy may appear, but usually late in the course

c. Weakness of the abductor pollicis brevis may be present

d. Phalen’s / Reverse Phalen’s signs may be positive

e. Tinel’s sign over the carpal tunnel may be positive

f. Closed Fist test – holding fist closed for 60 seconds reproduces median nerve paresthesia g. Evaluation of the contralateral wrist is recommended due to the frequency of bilateral involvement

h. Evaluation of the proximal upper extremity and cervical spine for other disorders including cervical radiculopathy, thoracic outlet syndrome, other peripheral neuropathies, and other musculoskeletal disorders

i. Signs of underlying medical disorders associated with CTS, e.g., diabetes mellitus, arthropathy, and hypothyroidism

j. Myofascial findings requiring treatment may present in soft tissue areas near other CTD pathology, and should be documented. Refer to the Division’s Cumulative Trauma Disorder Medical Treatment Guidelines.

Table 1: Sensitivities and Specificities and Evidence Level for Physical Examination findings

Procedure	Sensitivity (%)	Specificity (%)	Validity
1. Sensory testing
Hypesthesia	15-51	85-93	Good
Katz Hand Diagram	62-89	73-88	Good
Two-point discrimination	22-33	81-100	Some
Semmes-Weinstein	52-91	59-80	Some
Vibration	20-61	71-81	None
2. Phalen’s	51-88	32-86	Some
3. Tinel’s	25-73	55-94	Some
4. Carpal tunnel compression	28-87	33-95	Some
5. Thenar atrophy	3-28	82-100	Good
Abductor pollicis brevis weakness	63-66	62-66	Good
6. Closed fist test	61	92	Some
7. Tourniquet test	16-65	36-87	None

4. Risk Factors A critical review of epidemiologic literature identified a number of physical exposures associated with CTS. For example, trauma and fractures of the hand and wrist may result in CTS. Other physical exposures considered risk factors include: repetition, force, vibration, pinching and gripping, and cold environment. When workers are exposed to several risk factors simultaneously, there is an increased likelihood of CTS. Not all risk factors have been extensively studied. Exposure to cold environment, for example, was not examined independently; however, there is good evidence that combined with other risk factors cold environment increases the likelihood of a CTS. Table 2 at the end of this section entitled, "Risk Factors Associated CTS," summarizes the results of currently available literature.

No single epidemiologic study will fulfill all criteria for causality. The clinician must recognize that currently available epidemiologic data is based on population results, and that individual variability lies outside the scope of these studies. Many published studies are limited in design and methodology, and, thus, preclude conclusive results. Most studies' limitations tend to attenuate, rather than inflate, associations between workplace exposures and CTS.

These guidelines are based on current epidemiologic knowledge. As with any scientific work, the guidelines are expected to change with advancing knowledge. The clinician should remain flexible and incorporate new information revealed in future studies.

Table 2: Risk Factors Associated with Carpal Tunnel Syndrome

Diagnosis	Strong evidence	Good evidence	Some evidence	Insufficient or conflicting evidence
Carpal Tunnel Syndrome	Combination of high exertional force (Varied from greater than 6 kg) and high repetition (work cycles less than 30 sec or greater than 50% of cycle time performing same task, length of shortest task less than 10 sec).	Repetition or force independently, use of vibration hand tools.	Wrist ulnar deviation and extension.	Pinch/grip, keyboarding.

5. Laboratory Tests Laboratory tests are generally accepted, well-established, and widely used procedures. Patients should be carefully screened at the initial exam for signs or symptoms of diabetes, hypothyroidism, arthritis, and related inflammatory diseases. The presence of concurrent disease does not negate work-relatedness of any specific case. When a patient's history and physical examination suggest infection, metabolic or endocrinologic disorders, tumorous conditions, systemic musculoskeletal disorders (e.g., rheumatoid arthritis), or potential problems related to prescription of medication (e.g., renal disease and nonsteroidal anti-inflammatory medications), then laboratory tests, including, but not limited to, the following can provide useful diagnostic information:

a. Serum rheumatoid factor and Antinuclear Antigen (ANA) for rheumatoid work-up;

b. Thyroid Stimulating Hormone (TSH) for hypothyroidism;

c. Fasting glucose - recommended for obese men and women over 40 years of age, patients with a history of family diabetes, those from high-risk ethnic groups, and with a previous history of impaired glucose tolerance. A fasting blood glucose greater than 125mg/dl is diagnostic for diabetes. Urine dipstick positive for glucose is a specific but not sensitive screening test. Quantitative urine glucose is sensitive and specific in high-risk populations;

d. Serum protein electrophoresis;

e. Sedimentation rate, nonspecific, but elevated in infection, neoplastic conditions and rheumatoid arthritis;

f. Serum calcium, phosphorus, uric acid, alkaline and acid phosphatase for metabolic, endocrine and neoplastic conditions;

g. Complete Blood Count (CBC), liver and kidney function profiles for metabolic or endocrine disorders or for adverse effects of various medications;

h. Bacteriological (microorganism) work-up for wound, blood and tissue;

i. Serum B6 – routine screening is not recommended due to the fact that vitamin B6 supplementation has not been proven to affect the course of carpal tunnel syndrome. However, it may be appropriate for patients on medications that interfere with the effects of vitamin B6, or for those with significant nutritional problems.

The Department recommends the above diagnostic procedures be considered, at least initially, the responsibility of the workers' compensation carrier to ensure that an accurate diagnosis and treatment plan can be established.

E. Follow-up Diagnostic Testing Procedures

1. Electrodiagnostic (EDX) Studies are well established and widely accepted for evaluation of patients suspected of having CTS. The results are highly sensitive and specific for the diagnosis. Studies may confirm the diagnosis or direct the examiner to alternative disorders. Studies require clinical correlation due to the occurrence of false positive and false negative results. Symptoms of CTS may occur with normal EDX studies, especially early in the clinical course.

EDX findings in CTS reflect slowing of median motor and sensory conduction across the carpal tunnel region due to demyelination. Axonal loss, when present, is demonstrated by needle electromyography in median nerve-supplied thenar muscles. Findings include fibrillations, fasciculations, neurogenic recruitment and polyphasic units (reinnervation).

a. Needle electromyography of a sample of muscles innervated by the C5 to T1 spinal roots, including a thenar muscle innervated by the median nerve of the symptomatic limb, is frequently required.

b. The following EDX studies are not recommended to confirm a clinical diagnosis of CTS:

i. Low sensitivity and specificity compared to other EDX studies: multiple median F wave parameters, median motor nerve residual latency, and sympathetic skin response

ii. Investigational studies: evaluation of the effect on median NCS of limb ischemia, dynamic hand exercises, and brief or sustained wrist positioning

c. To assure accurate testing, temperature should be maintained at 30-34C preferably recorded from the hand/digits. For temperature below 30C the hand should be warmed.

d. All studies must include normative values for their laboratories.

e. Positive Findings – Any of these nerve conduction study findings must be accompanied by median nerve symptoms to establish the diagnosis.

i. Slowing of median distal sensory and/or motor conduction through the carpal tunnel region

ii. Electromyographic changes in the median thenar muscles in the absence of proximal abnormalities

f. Because laboratories establish their own norms, a degree of variability from the suggested guideline values is acceptable.

g. In all cases, normative values are to be provided with the neurodiagnostic evaluation.

h. Suggested grading scheme by electrodiagnostic criteria for writing a consultation or report may be:

i. Mild CTS-prolonged (relative or absolute) median sensory or mixed action potential distal latency (orthodromic, antidromic, or palmar).

ii. Moderate CTS-abnormal median sensory latencies as above, and prolongation (relative or absolute) of median motor distal latency.

iii. Severe CTS-prolonged median motor and sensory distal latencies, with either absent sensory or palmar potential, or low amplitude or absent thenar motor action potential. Needle examination reveals evidence of acute and chronic denervation with axonal loss.

i. Frequency of Studies/Maximum Number of Studies:

i. Indications for Initial Testing:

A) Patients who do not improve symptomatically or functionally with conservative measures for carpal tunnel syndrome over a 3-4 week period

B) Patients in whom the diagnosis is in question

C) Patients for whom surgery is contemplated

D) To rule out other nerve entrapments or a radiculopathy

ii. Repeated studies may be performed:

A) To determine disease progression. 8-12 weeks is most useful when the initial studies were normal and CTS is still suspected

B) For inadequate improvement with non-surgical treatment for 8-12 weeks

C) For persistent or recurrent symptoms following carpal tunnel release, post-op 3-6 months, unless an earlier evaluation is required by the surgeon

2. Imaging Studies

a. Radiographic Imaging: Not generally required for most CTS diagnoses. However, it may be necessary to rule out other pathology in the cervical spine, shoulder, elbow, wrist or hand. Wrist and elbow radiographs would detect degenerative joint disease, particularly scapholunate dissociation and thumb carpometacarpal abnormalities which occasionally occur with CTS.

b. Magnetic Resonance Imaging (MRI): Considered experimental and not recommended for diagnosis of Carpal Tunnel Syndrome. Trained neuroradiologists have not identified a single MRI parameter that is highly sensitive and specific. MRI is less accurate than standard electrodiagnostic testing, and its use as a diagnostic tool is not recommended.

c. Sonography: This tool has not been sufficiently studied to define its diagnostic performance relative to electrodiagnostic studies. It is not a widely applied test. Sonography may detect synovial thickening in CTS caused by rheumatoid arthritis. It may be useful if space-occupying lesions, such as, lipomas, hemangiomas, fibromas, and ganglion cysts, are suspected. Its routine use in CTS is not recommended.

3. Adjunctive Testing Clinical indications for the use of tests and measurements are predicated on the history and systems review findings, signs observed on physical examination, and information derived from other sources and records. They are not designed to be the definitive indicator of dysfunction.

a. Electromyography: is a generally accepted, well-established procedure. It is indicated when acute and/or chronic neurogenic changes in the thenar eminence are associated with the conduction abnormalities discussed above.

b. Electroneurometer: May serve as a diagnostic tool as it helps to detect early distal sensorineural impairment.

c. Portable Automated Electrodiagnostic Device: Measures distal median nerve motor latency and F-wave latency at the wrist and has been tested in one research setting. It performed well in this setting following extensive calibration of the device. Motor nerve latency compared favorably with conventional electrodiagnostic testing, but F-wave latency added little to diagnostic accuracy. It remains an investigational instrument whose performance in a primary care setting is as yet not established, and is not recommended as a substitute for conventional electrodiagnostic testing in clinical decision-making.

d. Quantitative Sensory Testing (QST): May be used as a screening tool in clinical settings pre- and post-operatively. Results of tests and measurements of sensory integrity are integrated with the history and systems review findings and the results of other tests and measures. QST has been divided into two types of testing:

i. Threshold tests measure topognosis, the ability to exactly localize a cutaneous sensation, and pallesthesia, the ability to sense mechanical using vibration discrimination testing (quickly adapting fibers); Semmes-Wienstein monofilament testing (slowly adapting fibers);

ii. Density Tests also measure topognosis and pallesthesia using static two-point discrimination (slowly adapting fibers); moving two-point discrimination (quickly adapting fibers).

e. Pinch and Grip Strength Measurements: May be accepted as a diagnostic tool for CTS. Strength is defined as the muscle force exerted by a muscle or group of muscles to overcome a resistance under a specific set of circumstances. Pain, the perception of pain secondary to abnormal sensory feedback, and/or the presence of abnormal sensory feedback affecting the sensation of the power used in grip/pinch may cause a decrease in the force. When all five handle settings of the dynamometer are used, a bell-shaped curve, reflecting maximum strength at the most comfortable handle setting, should be present. These measures provide a method for quantifying strength that can be used to follow a patient’s progress and to assess response to therapy. In the absence of a bell-shaped curve, clinical reassessment is indicated.

f. Laboratory Tests In one study of carpal tunnel patients seen by specialists, 9% of patients were diagnosed with diabetes, 7% with hypothyroidism, and 15% with chronic inflammatory disease including spondyloarthropathy, arthritis, and systemic lupus erythematosis. Up to two thirds of the patients were not aware of their concurrent disease. Estim