Texas Department of Insurance

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Adopted Rules

(continued from Part 1)

 

§137.100:  Commenter states no evidence exists indicating that ODG will compromise an injured employee’s access to spinal surgery.  Commenter also states that spinal surgeries will continue to go through the preauthorization process and can proceed to a review by an IRO if the insurance carrier denies preauthorization.  Commenter states spinal surgery utilization is still a problem in Texas, as indicated by the Research and Oversight Council’s January 2001 report “Striking the Balance: An Analysis of the Cost and Quality of Medical Care in the Texas Workers’ Compensation System,” and will be addressed in an appropriate manner by adoption of the ODG treatment guidelines. 

Agency Response: The Division agrees and clarifies that all spinal surgeries require preauthorization as established in §413.014 of the Labor Code.  If a health care provider recommends spinal surgery, preauthorization is required in accordance with §134.600.  The Division agrees that spinal injuries are a significant cost in the Texas workers’ compensation system and that ODG is a useful tool in managing spinal injuries.

§137.100:  Commenter states that the insurance industry is cognizant of the Texas Labor Code provision that prohibits the denial of health care based solely on the treatment guideline adopted by the Division or on the basis that health care being proposed or that has been rendered either exceeds the treatment guideline or is not included in the guideline.

Agency Response:  The Division notes that adopted §137.100(g), proposed as subsection (h), requires that the insurance carrier shall not deny treatment solely because the diagnosis or treatment is not specifically addressed by the Division treatment guidelines or Division treatment protocols.

§137.100:  Commenter urges the Division not to include a provision stating that health care treatment is automatically preauthorized if it falls within the treatment guideline.

Agency Response:  The Division agrees.  Adopted §137.100(e), proposed as subsection (f), states that an insurance carrier may retrospectively review, and if appropriate, deny payment for treatments and services not preauthorized under subsection (d) of this section when the insurance carrier asserts that health care provided within the Division treatment guidelines is not reasonably required.  The assertion must be supported by documentation of evidence-based medicine that outweighs the presumption of reasonableness established by Labor Code §413.017.

§137.100Commenter recommends changes to ODG’s treatment guidelines that adds the terms “electrical” to all references pertaining to “bone growth stimulators, ” and adds “therapy” to the title relating to “Cold /Heat Pack” to read “Cold Therapy/Heat Pack.”

Agency Response:  The Division declines to make the change.  Commenter’s specific recommendations for changes in language in ODG or other Division adopted guidelines is best addressed with the publisher of the guidelines.

§137.100:  Commenters state that the ratings given to a number of the abstracts in the low back chapter and a reference in the pain chapter from Kumar with regard to the use of spinal cord stimulation for failed back surgery syndrome (FBSS) are incorrect.  Commenter provides that in most of the examples provided, studies were classified as randomized controlled trials (Type 2) but were actually either cohort studies or case series, while other studies were classified as systematic reviews (Type 1) but were actually narrative reviews or other forms of evidence.  Commenter provides that ODG classified in error a case series by Kumar as a randomized controlled trial leading to the conclusion that spinal cord stimulators (SCS) are “recommended only for selected patients in cases when less invasive procedures have failed or are contraindicated for FBSS and complex regional pain syndrome (CRPS) Type 1.  Commenter believes more trials are needed to confirm whether SCS is an effective treatment for certain types of chronic pain and states that appropriately reclassifying the Kumar article would remove the evidence in favor of SCS for FBSS.  Commenter concedes that it is unknown the degree to which the classification errors found in the low back chapter exists in the other chapters of ODG and recommends identifying similar errors prior to using the stated information.  Commenter further recommends ascertaining the degree to which search criteria identified all relevant articles, the credentials of those rating the articles, and whether the ratings were based solely on reading the abstracts or the entire article.

Agency Response:  The Division believes the commenter has highlighted a unique strength of ODG.  Each treatment guideline summary and subsequent recommendation in ODG is hyper-linked into the studies on which it is based, in abstract form, which have been ranked, highlighted and indexed. (See "ODG Methodology Outline" at www.odg-disability.com/methodology_outline.pdf.)  This accountability and transparency in ODG lets users evaluate the strength of medical evidence behind guideline recommendations on their own.  Then, if they disagree with the ODG rating of a study, the ODG interpretation of a study, or if they think ODG has overlooked a specific study, they are encouraged to provide their feedback to the ODG authors, and these comments are then reviewed and reflected in the guidelines as appropriate.  The editorial effort behind ODG Treatment is an open process, and its success is based on its reputation for being (1) unique in taking evidence-based guidelines to their logical end point, with the conclusions linked directly to the evidence in the studies and references; (2) continuously updated reflecting the findings of new studies as they are conducted and released so subscribers are always up to date; (3) comprehensive, covering all types of treatments and the relevant studies; and (4) independent and multidisciplinary in scope.  (See "The Unique and Major Advantages ODG" at www.odg-disability.com/Advantages of Official Disability Guidelines.pdf.)

The Division disagrees that the rating studies on spinal cord stimulation are inaccurate.  The only specific example produced by commenter says, “ODG classified in error a case series by Kumar as a randomized controlled trial.”  The link shown in the Pain Chapter under Spinal cord stimulators (SCS) listed as “(Kumar, 2006)” says, "Rating: 4a" (www.odg-twc.com/odgtwc/pain.htm#Kumar4).  The rating level 4 is a Case Series and not a Controlled Trial (www.odg-twc.com/odgtwc/ExplanationofMedicalLiteratureRatings.htm).  Commenter says that in “most” of the examples provided, studies were classified as Type 2, while other studies were classified Type 1.  The Division does not agree with this assessment because there are a total of 41 studies cited under Spinal Cord Stimulation, and 6 received a Type 1 rating, while 8 received a Type 2 rating (less than 20% of the total, not qualifying as “most,” see www.odg-twc.com/odgtwc/pain.htm - SCS_References).  Commenter said that more trials are needed to confirm whether spinal cord stimulation is an effective treatment for failed back surgery syndrome.  The commenter’s opinion is not unreasonable, but ODG already limits the use of spinal cord stimulation to very unusual situations, since failed back surgery syndrome is the result of a failed spinal fusion, and ODG concludes, “Not recommended” for Fusion in the Low Back Chapter so ideally failed back surgery syndrome should almost never happen.  Commenter recommends identifying “similar errors” prior to using ODG.   The Division believes this is not an error and no “similar errors” have been identified.  Commenter further recommends ascertaining the degree to which search criteria identified all relevant articles, the credentials of those rating the articles, and whether the ratings were based solely on reading the abstracts or the entire article.  The evidence used for ODG is the complete article; however, ODG users have access to the abstract which serves as an article summary, and can help the user decide whether to review the complete article on their own.  See "ODG Methodology Outline" at www.odg-disability.com/methodology_outline.pdf for a complete description of methodology.

§137.100:  Commenter believes characterizing abstracts as evidence within the context of evidence-based medicine is inappropriate and potentially misleading. Abstracts are to be used as a guide to the evidence, but are not to be used in place of the evidence.  Commenter states that the ODG chapter on pain and the use of spinal cord stimulators recommends trial stimulation supported by a link to the abstract.  The user of ODG would assume from the statement and the link that the underlying medical study support trial stimulation.  Commenter provides that the link on ODG is to an abstract for a protocol for a Cochrane Review and, according to Cochrane, “a protocol is the rationale for the review,” not the systematic review itself.   Commenter states ODG does not provide a link to the actual systematic public study concluding the opposite of the ODG procedure summary that found “no data regarding the benefits of having a trial stimulation period.”  Commenter further states separate studies are not reaching different conclusions, but misuse of the very same study.

Agency Response:  The Division disagrees with commenter’s interpretation of ODG.  According to ODG methodology the complete article is reviewed.  ODG users have access to the abstract which serves as an article summary, and can help them decide whether to review the complete article on their own.  See "ODG Methodology Outline" at www.odg-disability.com/methodology_outline.pdf for a complete description of methodology.  The link at (Mailis-Gagnon-Cochrane, 2004) goes to a Cochrane systematic review (www.odg-twc.com/odgtwc/pain.htm - MailisGagnon) which says, "Mailis-Gagnon A, Furlan A, Sandoval J, Taylor R, Spinal cord stimulation for chronic pain, Cochrane Database Syst Rev. 2004;3:CD003783" and, "CONCLUSIONS: Although there is limited evidence in favour of SCS for Failed Back Surgery Syndrome and Complex Regional Pain Syndrome Type I, more trials are needed to confirm whether SCS is an effective treatment for certain types of chronic pain."  

§137.100:  Commenter states the representation that ODG covers conditions that represent over 99% of workers’ compensation costs is a gross overstatement.  For comparison, a 2004 study by the California Workers Compensation Institute showed that for California data, 30% of claims had diagnoses that were too non-specific to apply guidelines, and 20% were trauma, primarily lacerations and fractures.  Evidence-Based Medicine & The California Workers’ Compensation: A Report to the Industry, California Workers’ Compensation Institute, Harris, Swedlow, February 2004.

Agency Response:  The Division acknowledges differences among treatment guidelines.  Jeffrey S. Harris, MD, MPH, MBA, Alex Swedlow, MHSA, California Workers Compensation Institute, Evidence-Based Medicine & The California Workers’ Compensation System: A Report to the Industry, 14-17 (2004) states that trauma and non-specific claims involve 51.7% of all California workers’ compensation claims and 42.3% of total benefit costs, which the adopted state guidelines did not cover at the time of the report.  Additionally, the 2004 report notes that guidelines for trauma injuries that include fractures, burns, and lacerations were not expressly developed for the adopted California state guidelines due to well-defined treatment pathways and anecdotal studies of less treatment variability.  Based on the January 2004 report, a few of the primary diagnosis codes for non-specific claims that did not fit within the adopted California state guideline diagnostic criteria included 784.0-headache; 854.00-brain injury; 719.46-joint pain, lower leg, and 729.5-pain in limb.  However, there are notable differences between California’s adopted guidelines at the time of the reported study and the current ODG.  For instance, specific treatment guidelines are provided in ODG for injuries involving burns, the head, the leg, and pain.  Given the differences between the guidelines, the fact that a similar study specific to ODG and workers’ compensation injuries in the state of Texas has not been conducted, it is probable that the results would yield different comparative percentages.  Although a specific study has not been conducted to validate WLDI’s representations, the Division notes that ODG does cover all the major body parts likely to be involved in a workers’ compensation injury.  This comprehensiveness supports the conclusions that ODG addresses the overwhelming majority of workers’ compensation medical costs.

§137.100:  A commenter provides documentation which indicates that Lippincott Williams & Wilkins, the publisher of the Journal of Occupational and Environment Medicine (JOEM), has asked the Work Loss Data Institute to cease and desist from the use of JOEM abstracts and other JOEM publications because use of JOEM proprietary materials is unauthorized and must cease immediately, and because the Work Loss Data Institute is mischaracterizing the abstracts as evidence which is not the intended purpose of the JOEM abstracts.   

Agency Response:  It is the understanding of the Division that the abstracts are provided as a summary to assist the user in knowing which studies may be appropriate for review in order to evaluate the strength of the medical evidence behind the guidelines.  The reported controversy between Lippincott Williams & Wilkins, and the Work Loss Data Institute, referred to by the commenter, is a topic outside the scope of this rule making activity and does not affect the Division’s choice of the ODG treatment guidelines.  

§137.100:  Commenter states that ODG listed treatment guidelines written by health care entities such as Blue Cross and Aetna as a high quality reference when such guidelines have never been considered evidence in any other treatment guideline.  A high level systematic review only gives an article high quality weight when performed as a high quality randomized controlled trial.

Agency Response:  According to the WLDI Methodology Outline, ODG prefers an article written in the English language that satisfies a certain criterion. WLDI ODG gives preference to evidence that is a systematic review of the relevant medical literature.  WLDI considers an article that reports a randomized controlled trial or a controlled trial.  WLDI also considers an article that reports a prospective cohort study or a retrospective study.  WLDI further considers an article that reports a case control series involving at least 25 subjects in which the assessment of the outcome was determined by the person or entity independent from the persons or institution that performed the intervention, the outcome of which is being assessed.  When there are limited studies available with the preferred criteria, it becomes necessary to review other studies, and rank the evidence alphanumerically from 1a to 10c based on the type of evidence (1-Systematic Review/Meta-Analysis, 2-Controlled Trial –Randomized (RCT) or Controlled, 3-Cohort Study-Prospective or Retrospective, 4-Case Control Series, 5-Unstructured Review, 6-Nationally Recognized Treatment Guideline from guidelines.gov, 7-State/Other Treatment Guideline, 8-Foreign Treatment Guideline, 9-Textbook, 10-Conference Proceedings/Presentation Slides).  The evidence is further ranked by the quality within the type of evidence (a-High Quality, b-medium quality, and c-low quality) using the methodology in the second chapter of ODG.  Generally, using the ODG alphanumeric methodology, treatment guidelines from health care entities such as Blue Cross and Aetna would receive a rating of 7 - State/Other Treatment Guideline which is lower than a rating of 1 - Systematic Review/Meta-Analysis or 2 - Controlled Trial – Randomized (RCT) or Controlled unless studies from a health insurance company were published in the peer-reviewed literature, in which instance such studies could receive a higher ranking.  Further, whether a particular treatment is covered or not covered by health care insurance should be relevant to coverage decisions in workers’ compensation.

§137.100:  Commenter opines that ODG is overly comprehensive, including numerous low level studies. 

Agency Response:  The Division disagrees.  WLDI gives prefers an article written in the English language that satisfies a certain criterion. WLDI gives preference to evidence that is a systematic review of the relevant medical literature.  WLDI considers an article that reports a controlled trial-randomized or controlled.  WLDI considers an article that reports a cohort study, whether prospective or retrospective.  WLDI considers an article that reports a case control series involving at least 25 subjects in which the assessment of the outcome was determined by the person or entity independent from the persons or institution that performed the intervention the outcome of which is being assessed.  When there are limited studies available with the preferred criteria, it becomes necessary to review other studies, and rank the evidence alphanumerically from 1a to 10c based on the type of evidence (1-Systematic Review/Meta-Analysis, 2-Controlled Trial –Randomized (RCT) or Controlled, 3-Cohort Study-Prospective or Retrospective, 4-Case Control Series, 5-Unstructured Review, 6-Nationally Recognized Treatment Guideline from guidelines.gov, 7-State/Other Treatment Guideline, 8-Foreign Treatment Guideline, 9-Textbook, 10-Conference Proceedings/Presentation Slides).  The evidence is further rated by the quality within the type of evidence (a-High Quality, b-medium quality, and c-low quality) using the methodology in the second chapter of ODG.  According to David L. Sackett, William M.C. Rosenberg, J.A. Muir Gray, R. Brian Haynes, and W. Scott Richardson, Evidence Based Medicine: What It Is and What It Isn’t, BMJ 312 (7023), 13 January, 71-72, “if no randomized trial has been carried out for [the] patient’s predicament, we must follow the trail to the next best external evidence and work from there.” Further, Lisa A. Bero, Ph.D, Evaluating Systematic Reviews and Meta-Analyses, Journal of Law and Policy 580 (2006), citing, Debra J. Cook et. al., Should Unpublished Data Be Included in Meta-analyses? Current Convictions and Controversies, 269 JAMA 2749, 2749-53 (1993)  reports that the “majority of methodologists and journal editors now believe that unpublished data should be included in systematic reviews, suggesting widespread belief that important data remain unpublished.”

§137.100:  Commenter recommends an independent, in-depth assessment of proposed guidelines by qualified medical and epidemiologic professionals prior to adoption.  Commenter further states that sales or vendor presentations in support of particular proposed guidelines do not generally provide the specificity, depth, and breadth of analysis necessary to assure maximum benefit for injured employees.

Agency Response:  The Division disagrees that it has not thoroughly reviewed the adopted guidelines.  Prior to proposal, the Division considered the merits of various published return to work guidelines and treatment guidelines.  Several stakeholder and work group meetings were held to discuss the disability management concept and rules related to guidelines.  In addition, meetings were held with guideline publishers.  Representatives of various guidelines made presentations to Division staff and workers’ compensation system stakeholders regarding the development and use of their individual guidelines.  After reviewing and evaluating these guidelines and stakeholder input, as well as considering the recommendations of the Division’s Medical Advisor and the former Texas Workers’ Compensation Commission Medical Advisory Committee’s Return to Work workgroup, the Division selected the guidelines.

§137.100:  Commenter recommends that clarification be made as to potential physician licensing and malpractice allegations if the doctor performs a procedure or treatment within the adopted treatment guidelines, specifically surgical discectomy.  Commenter questioned whether doctors violate the standard of care in Texas if they follow the Division treatment guidelines.

Agency Response:  The Division acknowledges the concern regarding a physician’s compliance with a duty to follow the standard of care in the medical profession when treating an injured employee.  The Division clarifies that all spinal surgeries require preauthorization in accordance with Labor Code §413.014 and preauthorization requests are evaluated for medical necessity on a case-by-case basis.  The Division disagrees that treatment guidelines establish the standard of care for a physician in Texas.  The WLDI discloses in its ODG treatment guidelines that it is “not engaged in rendering medical advice, legal, or professional advice.   The final opinion regarding any medical condition and the ability of a patient to return to work should rest with the physician.”  According to medical literature, treatment guidelines do not establish legal standards for clinical care but may provide the courts with a benchmark by which to determine clinical conduct in the workers’ compensation system.  Brian Hurwitz, How Does Evidence Based Guidance Influence Determinations of Medical Negligence?, 329 BMJ 1028 (2004); Ash Samanta, M.D., L.L.B., Jo Samanta, B.A., Michael Gunn, L.L.B., Legal Considerations of Clinical Guidelines: Will NICE Make A Difference?, 96 Journal of the Royal Society of Medicine, 134 (2003).  This perspective from the medical literature appears consistent with the legal precedence in Texas.   In Denton Regional Med. Ctr. v. Lacroix, 947 S.W. 2d 941, 951 (Tex. App. Fort Worth 1997), the court held that although it may consider the hospital’s internal policies and bylaws, as well as the Joint Commission on Accreditation of Health Care Organizations standards in determining the standard of care, those factors alone do not determine the standard of care. Therefore, it is the Division’s opinion, that in using the treatment guidelines as only a benchmark for determining appropriate care, the physician must ultimately consider the individual circumstances and needs of the injured employee and act according to the applicable standards of care for his particular medical profession.  The Division acknowledges that injured employees may require more or less treatment than provided in the treatment guidelines based on the specifics of the injury.  The disability management rules recognize this and a variance from the guidelines should be supported by documentation.

§137.100:  Commenter states it is incorrect that ODG is not evidence-based and that the methodology is flawed.  Commenter includes an outline of ODG’s methodology, which provides detail as to how ODG is created and remains evidence-based.  Commenter additionally states that reviewers use actual studies, not abstracts, to formulate the conclusions for the guidelines and abstracts are provided as an accommodation to the subscribers.  Commenter states an observation has been made that the guidelines lack evidence‑based medicine.  Commenter notes that the summarizations in ODG can only be as good as the studies that have been conducted and are available.  Consequently, ODG can only rely on what's being studied and what is being released in terms of results and outcomes based on evidence-based science.   ODG reads the studies themselves; however, only the abstracts are provided because it would be impossible to include the entire studies in a book or a database.  In addition, studies are sometimes not available for publication.  Commenter states that ODG provides on its website a dynamic database that provides the most current updates of studies or clinical trials.  Commenter further states system participants are encouraged to utilize ODG’s web-based version because the print version does not include studies completed and released after the annual publication of the hard-copy ODG.  In addition, ODG offers discounts for system participants who choose to subscribe to the ODG web version rather than the book version.

Agency Response:  The Division acknowledges the comments regarding ODG.

§137.100:  Commenters state that ACOEM guidelines are the only treatment guidelines under consideration that meet the statutory standard outlined in Labor Code §413.011(e), and recommends its sole adoption in the State of Texas.  Commenters state that ACOEM practice guidelines are the highest quality and most scientifically based and empirically validated guidelines currently available.  Commenters further state that the ODG treatment guidelines do not meet the scientific principles for evidence-based medicine, therefore, not meeting the statutory tests of §413.011(e).  A treatment guideline that references links to abstracts may appear to be evidence-based, but does not meet the Labor Code standard of being “scientifically valid.”  Commenter provides that ODG does not follow most of the steps integral to the widely accepted evidence-based medicine process described in the referenced publications.  Commenter further provides that ODG does not describe the expert review and consensus process used to make testing and treatment recommendations or a scheme for rating individual systematic reviews or the body of high quality evidence to support each recommendation.  Commenter comments that ODG does not describe its process for a multidisciplinary review or for external review other than a reference to an Editorial Advisory Board.  Commenter provides examples and documentation to support this position.

Agency Response:  The Division disagrees that ACOEM guidelines are the only guidelines that meet the statutory standards.  The ODG treatment guidelines meet the statutory requirement for adoption in the State of Texas.  Labor Code §413.011(e) requires the Commissioner to adopt treatment guidelines that are evidence-based, scientifically valid, and outcome-focused and designed to reduce excessive or inappropriate medical care while safeguarding necessary medical care.

The ODG guidelines are evidence-based.  Labor Code §401.011 (18-a) defines “evidence-based medicine” to mean “the use of the current best quality scientific and medical evidence formulated from credible scientific studies, including peer-reviewed medical literature and other current scientifically based texts, and treatment and practice guidelines in making decisions about the care of individual patients.”  The RAND Institute defined evidence-based and peer-reviewed  to mean, at a minimum, a systematic review of literature published in medical journals included in the National Library of Medicine's MEDLINE,  (RAND, Evaluating Medical Treatment Guideline Sets for Injured Workers in California).  Finding that systematic reviews of the literature are standard and essential features of an evidence-based guideline development process, RAND determined that ODG was evidence-based and peer-reviewed, a criteria for inclusion in the RAND study of treatment guidelines. 

The ODG guidelines are scientifically valid.  ODG follows the steps integral to the process of creating evidence-based treatment guidelines.  WLDI describes its methodology for formulating the ODG treatment guidelines in the ODG Methodology Outline at  www.odg-disability.com/methodology_outline.pdf.   ODG Treatment also includes a detailed document entitled Appendix A, Methodology Description Using the AGREE Instrument.  This Appendix provides an extensive explanation of how ODG Treatment meets each of the 23 criteria established by the AGREE Instrument, including the rigorous means of developing the guidelines as described by the criteria for selecting the evidence and the methods used for formulating the recommendations.  The RAND Institute determined that ODG, and the other four guidelines studied, scored high in the rigor of development domain by clearly describing the methods used to search for evidence and formulate recommendations (RAND, Evaluating Medical Treatment Guideline Sets for Injured Workers in California, p. 32).. . 

The ODG guidelines are outcome-focused.  The information in ODG is a compilation of the current medical evidence that reflects the outcomes of new studies and clinical trials.  This data is integrated into the guidelines to reflect advances in medical technology, drug therapies, or alternative medicine techniques.  Application of this information in a clinical setting has a positive impact in shaping injured employee return to work outcomes.  The ODG Foreword notes that studies included in the ODG are focused on one outcome:  doing what is best for the injured employee.  Additionally, the ODG Foreword reports the results of a study conducted in Ohio by CompManagement, Inc.  The pilot study found that “following adoption of ODG statewide, results at CompManagement demonstrate savings in medical costs of 64 percent, in lost days of 69 percent, and minimized treatment delays.” 

Further, the ODG guidelines are designed to reduce excessive or inappropriate medical care while safeguarding necessary medical care by providing clear data on optimum frequency and duration of treatments.  The ODG treatment guidelines explain that claims should ideally be managed based on the details of the case using the “Procedure Summary.”  The ODG Procedure Summary includes possible therapies and diagnostic methods, and provides a summary and reference to the most recent medical evidence with an indication of whether the procedure is recommended, not recommended, or under study.  Within a Procedure Summary, ODG provides guidelines for instruction that include specific utilization review criteria often presented in an algorithmic format.  Quality and timely care in workers’ compensation cases have become synonymous with overall cost containment.  The level of cost containment is directly proportional to the degree of over-utilization of medical treatment currently experienced within the system.  Therefore, ODG satisfies the statutory requirement for adoption of treatment guidelines in the State of Texas.

The Division disagrees that ODG does not describe its process for rating the evidence for the treatment recommendation.  The process used to rate the evidence for the ODG treatment guidelines is provided in the ODG Explanation of Medical Literature Ratings, the Methodology Outline, and Appendix A, Methodology Description using the AGREE Instrument.  The Division disagrees that ODG does not describe its expert review process.  ODG Treatment includes a detailed document entitled Appendix A, Methodology Description using the AGREE Instrument.  This Appendix includes information about the involvement of stakeholders and further describes the review process by the ODG Editorial Advisory Board in the rigor development portion. 

§137.100:  Commenter states that the abstracts of studies are mostly the work of others and few are original to ODG.   Depending on journal policy, abstracts may be created for a variety of purposes, and cannot be presumed to represent “evidence” of a degree suitable for guideline development.  Abstracts cannot be presumed to represent evidence of a degree suitable for guideline development.     

Agency Response:  The Division clarifies that actual studies, not abstracts, are used to formulate the conclusions for the guidelines and abstracts are provided as an accommodation to the subscribers.  The RAND Institute determined that ODG, and the other four guidelines studied, scored high in the rigor of development domain by clearly describing the methods used to search for evidence and formulate recommendations (RAND, Evaluating Medical Treatment Guideline Sets for Injured Workers in California p. 32).

§137.100:  Commenters state that although ODG cites numerous abstracts and guidelines to support its conclusions, misclassification of the evidence, the use of a simplistic method to assess study quality, failure to identify the means through which low quality evidence was used for recommendations, and not providing a description of how the advisory panel functions do not meet the criteria for evidence-based guidelines as set forth in the Agree Criteria and similar documents in the peer-reviewed literature.

Agency Response:  The Division disagrees that ODG does not follow all of the steps integral to the process of creating evidence-based medical treatment guidelines.  ODG Treatment includes a detailed document entitled Appendix A, Methodology Description using the AGREE Instrument.  This Appendix provides an extensive explanation of how ODG Treatment meets each of the 23 criteria established by AGREE, including the rigorous means of developing the guidelines as described by the criteria for selecting the evidence and the methods used for formulating the recommendations.  The Appendix describes stakeholder involvement with a reference to the ODG Treatment in Workers’ Comp. Editorial Advisory Board.  The ODG Treatment Methodology Outline describes the review by the ODG Editorial Advisory Board.  The outline provides that “prior to publication, members of the ODG Editorial Advisory Board, as well as select organizations and individuals making up a cross-section of medical specialties and typical end-users externally review ODG Treatment in Workers’ Comp. This same review process is continued on an annual basis.”  According to the AGREE Instrument Training Manual 12 (2003), there is no standard by which the guideline advisory group should function, other than meeting the AGREE Instrument recommendation to have a representation of all the professional groups that are likely to use the guidelines, information about the composition of the guideline development group, which should include the affiliation and discipline of the group members.   The RAND Institute determined that ODG, and the other four guidelines studied, scored high in the rigor of development domain by clearly describing the methods used to search for evidence and formulate recommendations.  Further, the RAND study found that ODG, and the other guidelines studied, included most of the relevant groups in the guideline development process.  (RAND, Evaluating Medical Treatment Guideline Sets for Injured Workers in California p.32).

§137.100:  Commenter questions whether the guidelines are editorially independent from the funding body since the ODG methodology outline acknowledges that contributors may be compensated.  Commenter states that litigation is pending against the WLDI in federal court in the case of Ranavaya v. WLDI, U.S. District Court for the S.D. of West Virginia, Case No. 2:05-CV-109.  Commenter provides documentation of the complaint and states that the plaintiff alleges breach of contract in connection with a royalty agreement, breach of a confidentiality agreement, and conversion of confidential business information.  Commenter notes the pending litigation reveals that compensation to editors and contributors can include commissions on sales of products.  Commenter takes no position on the merits of the case. Commenter further states that item 22 of the Methodology Description Using the AGREE Instrument provides that “The guideline is editorially independent from the funding body.”  Commenter provides that ODG revised item 22 of the AGREE Instrument to state “The guideline is editorially independent from the functioning body.”

Agency Response:  The Division disagrees that ODG is not editorially independent from the funding body.  WLDI discloses in ODG that “the funding body is WLDI, an independent database development company focused on workplace health and productivity, founded in 1995, to create, maintain and market information databases to implement standards for managing workforce productivity based on strict principals of evidence-based methodology, with ongoing focus on health care cost containment.  There are no conflicts of interest among the guideline development members.”  The RAND Institute used the AGREE Instrument to evaluate the editorial independence of ODG.  (RAND, Evaluating Medical Treatment Guideline Sets for Injured Workers in California p. xx and. 33).  To demonstrate editorial independence, it is necessary to demonstrate that a guideline is editorially independent from the funding body, and that conflicts of interest of guideline development members are recorded.  Id. at 30.  Applying the AGREE Instrument, the RAND Institute, determined that ODG demonstrated the editorial independence of its development group.  Id. at p. xx and 33.

§137.100:  Commenter provides that procedural summaries should indicate whether linked articles are rated as high quality evidence or low quality evidence.  Commenter believes that listing low quality articles in the high quality article section mischaracterizes and bolsters the low quality article.  Commenter states there is no indication that the links meet the statutory requirements of being evidence based and scientifically valid.  Commenters provide examples to support this position.

Agency Response:  The Division disagrees.  Each article cited in ODG receives a rating, indicating the level of quality.  These quality ratings are contained with the article summary, and they are available to users when they click on the links to each article.  See, ODG Explanation of Medical Literature Ratings.  Within the Procedure Summaries, there are no high quality article sections or low quality article sections.  Each treatment guideline summary and subsequent recommendation in ODG is hyper-linked into the studies on which it is based, in abstract form, which have been ranked, highlighted and indexed.  See ODG Methodology Outline at www.odg-disability.com/methodology_outline.pdf.  These references allow users to evaluate the strength of medical evidence behind guideline recommendations. If they disagree with the ODG rating of a study, the ODG interpretation of a study, or if they think ODG has overlooked a specific study, they are encouraged to provide their feedback to the ODG authors.  The classification of the article as a high priority reference or a low priority reference appears after the procedure summary and in the summaries of the medical studies.  The summaries of the medical studies include a rating to evaluate the quality of the study.

§137.100(a):  Commenter recommends return to work and treatment guidelines be the same for both in network and non-network claims as it would be less confusing.

Agency Response:  The Division is unable to make this change because workers’ compensation networks are governed by the Insurance Code.  Workers’ compensation health care networks certified in accordance with Insurance Code §1305 may choose a treatment guideline or guidelines to suit their individual business requirements and health care models.  It is not feasible for the Division to adopt multiple guidelines and maintain a consistency with all certified networks.  The position of the Division is that this would create greater confusion and would not lead to any kind of consistency.

§137.100(a):  Commenter states ODG guidelines were formulated by occupational medicine doctors, and not orthopedic surgeons or neurosurgeons, even though orthopedic surgeons or neurosurgeons will manage 80-85% of the serious workers’ compensation injuries. 

Agency Response:  The Division disagrees.  According to the ODG Treatment in Workers’ Comp, 26 (2006); ODG Treatment in Workers’ Comp, Editorial Advisory Board, 5-8 (2006); and ODG Treatment in Worker’s Comp, Methodology Description Using the AGREE Instrument, 1573-1574 (2006), ODG is independent of any medical specialty group and multidisciplinary in scope.  These references further support that ODG represents various medical specialties, including occupational medicine doctors, orthopedic surgeons, chiropractors, and physical therapists.   

§137.100(a):  Commenter recommends the ODG treatment materials should efface any return to work content.  Commenter supports this recommendation with a statement that the effectiveness of MDA return to work guidelines may be jeopardized by the format and structure of the ODG’s intermingling of return to work guidelines throughout their treatment recommendations.  This intermingling will expose non-network claims users to the risk of applying the incorrect ODG return to work information on Texas employees.

Agency Response:  The Division agrees and §137.100 is revised to indicate that the adoption of ODG Treatment in Workers Comp does not include the ODG return to work pathways.

§137.100(a):  Commenters support ODG.  A commenter states the ODG offers strong evidence-based support for the use of behavioral interventions among injured employees and for those with chronic conditions.  Another commenter states the adoption of ODG will best serve the purpose intended by the Texas Legislature to serve as a treatment guideline required for use in non-network claims.  Commenters state ODG incorporates an integrated approach, which includes a section promoting patient education and involvement in their own care.  Commenter also states ODG is used successfully in 13 other states and provinces, decreases costs, and is totally independent, not related to any medical organization.  Commenter states they have adopted and utilize ODG treatment guidelines as an educational tool for member physicians, especially for non-occupational medicine doctors.  Commenter also states that for physicians who have purchased ODG the cost has not been an issue.

Agency Response:  The Division appreciates the supportive comments regarding the use of ODG.

§137.100(a):  Commenter opines that sections of the ODG do not have a specific evidentiary basis, and provides the example of intervals between medical visits and number of physical therapy visits outlined.  Commenter states there may be incongruence between the health care provider’s treatment plan and what is in the guidelines. 

Agency Response:  The Division agrees that although in certain circumstances incongruence between the guidelines and the health care provider’s treatment plan may occur, both health care providers and insurance carriers must apply the disability management concepts in a manner that supports the goal of improved return to work outcomes.   

§137.100(a):  Commenter recommends deletion of a bifurcated system approach (e.g., network vs. non-network) with the following language substitution:  “Health care providers shall provide treatment in accordance with treatment guidelines that are being used by workers’ compensation health care networks.”

Agency Response:  The Division disagrees.  Such an approach leads to uncertainty as to which guideline is being used.  Network choices are based on individual business practices and health care models adopted by the network and are not necessarily consistent between networks.  Consequently, it is not feasible for the Division to adopt the same guidelines as certified health care networks and maintain a consistency with all certified networks.

137.100(a):  Commenter recommends the use of ACOEM as a treatment guideline.  Commenters, in the alternative, suggest use of two guidelines when the primary guideline does not address the condition or procedure.  Commenter recommends the use of ACOEM and ODG while the Division reevaluates both in more depth.  Commenter suggests using ACOEM as the primary guideline and ODG as the secondary guideline for treatment not covered by ACOEM.  Commenter further recommends the use of other guidelines or evidence when a condition or procedure is not sufficiently addressed by ODG or ACOEM.  Another commenter states the proposed rule will create significant confusion among Texas employees, network health care providers and third parties because the Division has selected a single treatment guideline that would apply only in non-network care.  Commenter asserts that the validity of ODG evidence-based guidelines being linked to the evidence in the studies and references relevant to specific treatment is questionable.  ODG guidelines are based on selected studies, many of which do not meet reasonable, scientific criteria.  Commenter believes ODG does not include a comprehensive and critical review of relevant literature in support of many of the guidelines, especially those related to the management of pain.  Commenter additionally disagrees that ODG meets the criteria for recognition by AHRQ, as official acknowledgment of privately sponsored guidelines does not exist. 

Agency Response:  The Division declines to adopt ACOEM instead of ODG, or to adopt ACOEM in addition to ODG, at this time.  The adopted ODG meets the requirement of the Labor Code, is consistent with the goals of the Division and at this time best meets the objectives of HB 7.  However, the Division agrees that documentation may be submitted to support a diagnosis or treatment not addressed by ODG.  Such documentation could include other guidelines, such as ACOEM, when certain treatments or services are not included or addressed by ODG.  The Division disagrees that confusion will occur among Texas employees, network health care providers and third parties because the Division has selected a single treatment guideline that would apply only in non-network care.  The Division disagrees that ODG does not include a comprehensive review of the literature in support of the treatment guideline.  Actual studies, not abstracts, are reviewed to formulate the guideline recommendations.  The ODG Methodology Outline provides sufficient detail about the development of ODG.  The recommendations are based on the available studies that have been conducted and released, noting that studies are sometimes not available for publication.  With regard to the management of pain, ODG includes a treatment guideline devoted specifically to pain.  ODG indicates that its higher priority references for the management of pain address behavioral interventions, complementary alternative medicine, injections, low back pain, medical treatment guidelines, medications, assessment and management, chronic pain, miscellaneous, psychological evaluation and treatment, reflex sympathetic complex regional pain syndrome, therapeutic intervention, and spinal cord stimulation.  ODG at 1258-1272.  ODG indicates that its low priority references for the management of pain address complimentary alternative medicine, injections, low back pain, medical treatment guidelines, medications, assessment and management, chronic pain, miscellaneous, psychological evaluation and treatment, and therapeutic intervention. ODG 1273-1276.  The Division acknowledges that inclusion of a guideline in the National Guideline Clearinghouse does not constitute an endorsement or recognition by AHRQ or any of its contractors of the guideline. 

§137.100(a):  Commenter recommends adoption of at least one set of treatment guidelines that have been developed by the medical profession, such as ACOEM.  Commenter states this would ensure that practicing orthopedists have the flexibility to treat injured employees in the most clinically appropriate way and to ensure consistency with care that may be provided in network settings.

Agency Response:  The Division declines to make the recommended change.  The adopted ODG meets the requirement of the Labor Code, is consistent with the goals of the Division, and best meets the objectives of HB 7.  The Division anticipates health care providers’ ability to use these tools, and the treatment guidelines as a framework to develop treatment for injured employees.  The health care provider must consider care above or below the guidelines consistent with the unique factors associated with an injury.  The rules anticipate certain care outside or inconsistent with the treatment guidelines be managed through treatment planning and coordinated with the preauthorization process. Injured employees continue to be entitled to necessary medical care in accordance with Labor Code §408.021.  The Division will monitor the use of the disability management tools by all system participants to assure compliance with the intent of HB 7. 

§137.100(a):  Commenter is encouraged that the chosen guidelines meet the National Guidelines Clearinghouse’s inclusion criteria.  Commenter recommends that the Division consider development of a continuous monitoring of treatment guidelines implementation with practicing physician input.  Commenter states the Division should understand that no single set of guidelines will address all medical situations and that adopted guidelines will be imperfect and need constant review and editing.

Agency Response:  The Division position is that meeting the criteria for inclusion in the National Guidelines Clearinghouse registry supports the selection of ODG as Division treatment guidelines.  The Division also agrees that the studies and research supporting evidence-based medicine are dynamic.  ODG’s web version includes ongoing review and updates as new research and studies become available.

§137.100(a):  Commenter recommends clarification to state that treatment in conformance with the adopted guidelines are binding unless a particular patient has a diagnosis or needs a therapy regimen, surgery or treatment not covered by the ODG treatment guidelines.  Commenter states that ODG is not a default treatment guideline to a preferred one selected by the insurance carrier.

Agency Response:  The Division disagrees that additional clarification is necessary.  Care within the guidelines is presumed reasonable and reasonably required as stated in §137.100(c).  Such care may be retrospectively reviewed by the insurance carrier to confirm medical necessity.  Care not addressed by the guidelines or that exceeds the guidelines requires preauthorization, in some cases the preauthorization request may be through a treatment plan.  The Division agrees that ODG is the adopted Division treatment guidelines. 

§137.100(a):  Commenter recommends the adoption of one treatment guideline for the workers’ compensation system, as this would facilitate recruitment of physicians. 

Agency Response:  The Division agrees that treatment and return to work guidelines help establish benchmarks for treatment and return to work for the workers’ compensation system.  Standards tend to clarify the expectations of system participants and should, when fully integrated into the system, decrease administrative hassles.  In the long term this approach should improve injured employees’ access to care.

§137.100(c):  Commenters have concerns with provisions in the rule proposals that would allow health care providers to submit treatment plan for services that are provided in accordance with the Division treatment guidelines. Submission of a treatment plan to an insurance carrier for preauthorization for services that are presumed to be “reasonable” and “reasonably required” to the insurance carrier would unnecessarily add requirements and costs to stakeholders.

Agency Response:  The Division agrees that this provision when applied with proposed §137.100(d) could be burdensome to insurance carriers. Subsection (d), as proposed, is deleted and clarifying language regarding care within the guidelines and treatment plans has been added to §137.300.

§137.100(c):  Commenter recommends the rule require IROs to consider the treatment guidelines adopted and explain any deviation.

Agency Response:  The Division disagrees that additional language regarding IROs is necessary or appropriate within this section.  The position of the Division is that IRO decisions should be fully explained and documented in accordance with applicable IRO rules.

§137.100(c):  Commenter recommends deleting the §401.011(22-a) Labor Code reference from the rule, so that the subsection would read, “Health care provided in accordance with the Division treatment guidelines is presumed reasonable as specified in Labor Code §413.017.” 

Agency Response:  The Division disagrees with commenter’s recommendation because inclusion of both statutory definitions is necessary to properly convey the Division’s policy which includes both reasonable and reasonably required health care.

§137.100(c):  Commenter recommends clarification that presumption of reasonableness of care will only be applied when the underlying diagnosis of the care is undisputed, or upon final resolution of the diagnosis in dispute.

Agency Response:  The Division disagrees with commenter’s recommendation because issues of compensability, extent of injury and liability and how those issues are resolved are outside the scope of this rule.  These new sections relate to disability management and any issues of compensability, extent of injury and liability will still need to be addressed by the appropriate statutes and rules.  

§137.100(c):  Commenters recommend adding the following language to subsection (c):  “Health care services should not be denied or approved simply because they are included or excluded from the Division treatment guidelines.”  Not all services listed in the guidelines will be medically necessary for every patient, just as some patients may need services in excess of those listed in accordance with the treatment guidelines.  The basis of evidence-based guidelines is that the clinical presentation of the patient allows the physician to prescribe the most appropriate and effective treatment. 

Agency Response:  The Division declines to make the recommended changes.  Adopted subsection (e) allows insurance carriers to retrospectively review treatment within the guidelines for medical necessity.  This is consistent with the concept that not all care is necessary in every instance.  

§137.100(c):  Commenter believes the intent of HB 7 and these rules is that treatments contemplated in the guidelines are presumed appropriate and necessary only where the health care provider’s diagnosis is based on objective, documented, evidence-based medical findings (e.g., not subjective complaints alone) be clearly stated in the rule.  Commenter states this concept helps to clarify what health care providers must do before enjoying the presumption of medical necessity.

Agency Response:  The disability management concept and corresponding guidelines are intended as a tool to assist system participants not to limit necessary health care services.  If an insurance carrier disputes a diagnosis they may seek a treating doctor examination to define the compensable injury or a designated doctor examination.  The Division clarifies that issues related to compensability, extent of injury and liability are outside the scope of this rule.  

§137.100(c):  Commenter is concerned that this subsection is too rigid and does not take into account claims in which the treatment required to “cure or relieve” the compensable injury will exceed the adopted treatment guidelines.

Agency Response:  The Division acknowledges the commenter’s concerns and notes that the adoption of treatment guidelines does not diminish the provisions of §408.021 of the Labor Code.  The adopted disability management rules are intended to facilitate the efficient delivery of health care and promote early and appropriate return to work. 

§137.100(d) and §137.300(b):  Commenter recommends reduction of the “hassle factor” in order to get more medical providers back into the workers’ compensation system.  Commenter recommends that if treatment guidelines are adopted, then a doctor treating within the guidelines should be automatically preauthorized and automatic preauthorization means that they will be paid unless it is found non-compensable.  

Agency Response:  The Division agrees that reducing hassle factors in the workers’ compensation system is an important concept in developing a health care provider-friendly environment and intends for the treatment guidelines to provide a framework of benchmarks for system participants.  These benchmarks help define expectations and health care providers benefit from clear expectations.  The Division disagrees that care within the guidelines be deemed preauthorized.  Although care within the guidelines is presumed reasonable and reasonably required, it is unlikely that all care within the guidelines will be medically necessary or required in each specific case.  The treatment guideline rule allows the insurance carrier, when appropriate, to deny payment for care that is not medically necessary even though the care was included in the guideline.  That denial of payment must be supported by documentation of evidence-based medicine that outweighs the presumption of reasonableness established by Labor Code §413.017.

§137.100(d):  Commenter supports the inclusion of the term “health care provider” as opposed to doctor throughout the rule as it keeps the proposed rule consistent with the Division preauthorization rule.

Agency Response:  The Division agrees that the reference was not clear and subsection (d) is deleted.  Reference to this process is more appropriately addressed in the §137.300 and is clarified in that section. 

§137.100(d):  Commenter states that to require preauthorization of a treatment plan negates voluntary certification as allowed by §413.013(f).  Another commenter also suggests that education efforts are needed to promote the more appropriate use of voluntary certification for participants, as commenter advocates for the deletion of the proposed preauthorization of care for treatments and services within the adopted guideline.  Commenters also state that this provision is in conflict with Labor Code 413.014(f), which provides that an insurance carrier and health care provider may voluntarily discuss health care treatment and treatment plans, and, the insurance carrier may certify or agree to pay for health care consistent with these agreements. 

Agency Response:  The Division disagrees the treatment guidelines conflict with the Labor Code.  Insurance carriers and health care providers may continue to discuss and voluntarily certify care not subject to the preauthorization and concurrent review requirements of Division §134.600.  The Division disagrees that additional education efforts are necessary to facilitate voluntary certification.  After four years of Division data collection efforts regarding preauthorization and voluntary certification, it is noted that voluntary certification is used infrequently.  Anecdotally, health care providers have reported to the Division the unwillingness of insurance carriers to significantly participate in the voluntary certification process.

§137.100(d):  Commenter states that the insurance carrier is allowed to deny any recommendation beyond the guidelines as being unreasonable or not medically necessary, while the rule as a whole seems to state all medical treatment is limited to that provided in the guidelines, or subject to a preauthorized treatment plan when the proposed treatment exceeds the guidelines.

Agency Response:  The Division clarifies that injured employees are entitled to medical services as specified in the Labor Code.  Adoption of treatment guidelines and treatment planning provide benchmarks for system participants to develop treatment for injured employees.  The Division anticipates certain care may be outside or inconsistent with the treatment guidelines and in order to efficiently manage those situations the rules implement treatment plans so that injured employees may continue to receive necessary medical care in accordance with the Labor Code.

§137.100(d):  Commenter recommends if the proposed requirements for treatment plans are adopted, then commenter recommends deletion of subsection (d).  Commenter states the rules as proposed could be an unnecessary administrative burden on system participants.

Agency Response:  The Division clarifies that subsection (d) as proposed is deleted.  Requirements related to treatment planning are included in §137.300.

§137.100 (d) and (f):  Commenter states that the implementation of these rules will be a learning curve and behavior change for all system participants, and further states no one should believe that medical necessity denials for inappropriate care will cease with adopted treatment guidelines.

Agency Response:  The Division believes that the framework of treatment guidelines and treatment planning should lead to a better understanding of overall system benchmarks.  Appropriate consistent use and application of these tools should decrease inappropriate treatments and inappropriate denials of medical necessity.

§137.100 (d) and (f):  Commenter recommends the deletion of subsections (d) and (f) so that all health care rendered within the treatment guidelines is considered reasonable and appropriate.  Commenter believes the provisions of subsections (d) and (f) are contrary to legislative intent as the rationale behind HB 7’s requirement in §413.011 of the Labor Code is to adopt treatment guidelines that provide the workers’ compensation system with a communication tool whereby both health care providers and insurance carriers would have a mutual understanding that health care provided within the guidelines is considered appropriate and medically necessary.  Commenter states the proposed rules increase the administrative burden of the health care provider.  This burden is exacerbated by the ability of the insurance carrier to deny on relatedness and the inability of these rules to address compensability issues.  This will result in more health care providers leaving the workers’ compensation system.

Agency Response:  The Division disagrees that subsections (d) and (f) are contrary to legislative intent.  However, proposed subsection (d) is deleted from this rule and clarifying language is added to §137.300 to specify the requirements of treatment planning.  As a result of that deletion, subsection (f) is now subsection (e).  Although care provided within the guidelines is presumed to be reasonable, renumbered subsection (e) identifies that this is a rebuttable presumption based on the specific facts of the claim. Not all injures will need all care identified in the guidelines and some claims may need treatments or services not identified or in excess of the guidelines.  The Division notes that the disability management rules have not been developed to deal with compensability or extent issues that are addressed in other Division rules.  The Division believes adoption and implementation of the disability management concept and associated rules will increase communication opportunities for system participants, bring structure and certainty to the process, and ultimately decrease administrative burdens for system participants.

§137.100(d):  Commenters recommend deleting subsection (d), including the deletion of the reference to subsection (d) in subsection (f).  As the proposed rules already presume that all treatment according to the treatment guidelines are reasonable and necessary, commenters state that there is no reason to permit the medical provider to submit a request for preauthorization of a treatment plan within treatment guidelines.  Commenters believe that submission of a treatment plan for services presumed to be “reasonable” and “reasonably required” is duplicative and adds unnecessary costs and time to stakeholders for the preauthorization process, retrospective audit for preauthorization validation, increased use of the reconsideration process, and increased medical dispute resolution costs, including IRO fees.  Sections 137.100(g) and 137.300(a) include provisions that address when treatment plans are required for submission to the insurance carrier for a medical necessity determination.  Commenters further opine that health care providers are afforded resolution of conflicts under Division rules 133.305, 133.307, 133.308, 134.650, and 134.600(r).  A commenter suggests this rule provision will increase the number of medical disputes and undermine the treatment guideline by providing for a back-door through which a health care provider can obtain a prospective guarantee of payment of medical bills.

Agency Response:  The Division disagrees that proposed subsections (d) and (f) are duplicative of other rule provisions.  However, proposed subsection (d) is deleted from this rule and clarifying language is added to §137.300 to specify the requirements of treatment planning.  Although care provided within the guidelines is presumed to be reasonable, subsection (e) identifies that this is a rebuttable presumption based on the specific facts of the claim.  Not all injuries will need all care identified in the guidelines and some claims may need treatments or services not identified or in excess of the guidelines.  Although proposed subsection (d) is deleted and additional language is added to §137.300, the Division disagrees that this provision would be duplicative.  This approach prevents unnecessary care and overutilization and insulates health care providers from the cost of providing services that the insurance carriers deem not medically necessary.  The Division notes that language has been added to §137.300 to clarify when treatment within the guidelines should be included in a treatment plan.

§137.100(e):  Commenter recommends that if treatment is provided in excess or beyond the scope of the adopted treatment guidelines, then the health care provider should be afforded a peer-to-peer interview with the insurance carrier’s doctor within 24 hours.

Agency Response:  The Division disagrees that additional direction is required regarding the preauthorization process.  Peer-to-peer reviews are accounted for in §134.600.  In addition, the time frames established in §134.600 are consistent with Insurance Code, Article 21.58A.

§137.100(e):  Commenter expresses concern that the rule as proposed does not explicitly clarify how it dovetails with the preauthorization rule 134.600.  Unless clarified, confusion is going to arise about when the treatment guideline rule or the preauthorization rule takes precedence.

Agency Response:  The Division notes the commenter’s concern and clarifies that details related to treatment planning in proposed §137.100 are deleted, and additional language regarding the relationship between preauthorization, treatment guidelines and treatment planning is added to §137.300.

§137.100(e)(2):  Commenter requests clarification as to whether the term “treatment plan” is actually the intended term, or if the subsection refers to any and all services preauthorized in accordance with §134.600.

Agency Response:  The Division notes that subsections (d) and (e) are changed to clarify which services an insurance carrier is liable for in excess of the Division treatment guidelines.

§137.100(e):  Commenter recommends a new subsection (e) be added, with subsequent subsection re-numbering, to read, “The insurance carrier may not deny payment for health care services delivered in accord with treatment guidelines defined in subsection (a) of this section or an approved treatment plan as defined in section 137.300, relating to Treatment Planning.”

Agency Response:  The Division declines to make the change.  Although care within the guidelines is presumed reasonable and reasonably required, it is unlikely that all care within the guidelines will be medically necessary or required in each specific case.  The treatment guideline rule allows the insurance carrier, when appropriate, to deny payment for care that is not medically necessary even though the care was included in the guideline.  That denial of payment must be supported by documentation of evidence-based medicine that outweighs the presumption of reasonableness established by Labor Code §413.017.  The Division notes that preauthorized care, including preauthorized treatment plans, are not subject to retrospective review of medical necessity.  However, other factors, such as compensability or compliance with other billing requirements, could result in denial of reimbursement.

§137.100(f):  Commenter states the rules only require the denying party to reference the source of their denial by simply stating their denial is based on ODG guidelines without being required to identify the specific component of the guidelines alluded to.  Commenter states the main problem anticipated is that whatever guidelines are adopted, they will be used in the context of denying treatment.

Agency Response:  The Division notes that division rules related to medical billing and reimbursement identify the specific requirements for denial of medical bills.  The adopted guidelines establish an initial framework for reasonably required medical care.  Although use of guidelines may result in denial of some services, and subsequently, some related medical necessity disputes, the adopted treatment guidelines provide a consistent benchmark for system participants.  Overall, adoption of the disability management rules facilitates communication between system participants resulting in improved return to work outcomes. 

§137.100(f):  Commenter recommends the rules clearly define the responsibility of any reviewing physician to ensure all appropriate medical records are obtained, and states the rules are not sufficiently strong enough when addressing this issue.  Commenter recommends the entity denying the recommendations of the orthopedic surgeon should be required to be a licensed practicing orthopedic surgeon in Texas, who is an active fellow of AAOS. This concept should apply at all levels of any appeals process.

Agency Response:  The Division declines.  Standards related to the review of proposed medical care and retrospective review of medical care are already defined in the Insurance Code and Division rules, therefore, no additional clarification is needed. Insurance Code 21.58A includes specific requirements for peer-to-peer reviews.

§137.100(f):  Commenter opines that a doctor who performs as a patient advocate in initiating medical necessity appeals should not be penalized by having to pay the IRO fee.  Commenter further objects to allowing an insurance carrier’s critique of the patient’s case and subsequently identifying new issues of contention.  Labor Code §413.031 relating to Medical Dispute Resolution establishes which party in a medical necessity dispute is responsible for the IRO fee.

Agency Response:  The Division recognizes the commenter’s concern but notes that these issues are outside the scope of this rule making initiative.

§137.100(f):  Commenter recommends a revision to add (e) after the reference to (d) otherwise, insurance carriers may retroactively deny services even if they have been preauthorized or rendered in an emergency.

Agency Response:  The Division declines to make the recommended change.  However, proposed subsection (d) is deleted from this rule.  Further, the Division clarifies that services preauthorized in accordance with §134.600 are not subject to retrospective review of medical necessity as noted in Labor Code §413.014.

§137.100(f):  Commenter recommends adding the words “in excess of treatment guidelines and …”  Commenter additionally recommends the deletion of the rest of the sentence referencing subsection (d). 

Agency Response:  The Division declines to make the recommended change, however proposed subsection (d) is deleted.  Additionally, the Division clarifies that proposed subsection (f) (adopted subsection (e)) establishes that the insurance carrier may retrospectively review health care provided within the treatment guidelines unless it has been preauthorized or voluntarily certified.  Health care that exceeds the treatment guidelines is required to be preauthorized in accordance with §134.600.

§137.100(f):  Commenters recommend deleting the following language from subsection (f):  “…not preauthorized under subsection (d) of this section” and “...that outweighs the presumption of reasonableness established by Labor Code 413.017,” in order to provide consistency with the recommendation to delete subsection (d).

Agency Response:  The Division declines to make the recommended changes. Subsection (d) as proposed is deleted and new subsection (d) pertains to the insurance carriers’ liability for certain health care.  The Labor Code §413.017 establishes the presumption of reasonableness. Deletion of the language “...that outweighs the presumption of reasonableness established by Labor Code §413.017,” would effectively negate the presumption of reasonableness established by the Labor Code.

§137.100(f):  Commenters recommend the following phrase addition to the last sentence, “…or that demonstrates that the claimant has not benefited from the same or similar type of treatment in the past.”

Agency Response:  The Division declines to make the recommended change. Medical necessity is established on a case-by-case basis consistent with the principles of evidence-based medicine.  A specific blanket statement as indicated is potentially contrary to the concept of evidence-based medicine as applied to an individual case. 

§137.100(f):  Commenters suggest the proposed rule may be so restrictive that insurance carriers may not have the tools to combat medical billing, over-utilization, fraud and abuse as the proposal potentially prohibits the insurance carrier from denying payment in claims when the claimant may have fully recovered from the compensable injury prior to the rendition of care within the guidelines. 

Agency Response:  The Division disagrees.  Adopting the disability management concept leaves all the tools previously available to insurance carriers in place.  Further, these disability management rules provide for an improved communication process for health care providers and insurance carriers to discuss an injured employees’ health care and offer insurance carriers excellent tools to evaluate the utilization of health care.  In addition, subsection (e) allows an insurance carrier to retrospectively review health care provided within the treatment guidelines.  The Division is committed to removing fraud and abuse from the workers’ compensation system but is equally committed to safeguarding necessary medical care for injured employees. 

§137.100(h):  Commenter recommends changes to subsection (h) to read, “the insurance carrier shall not deny treatment ‘or payment’ solely because the diagnosis or treatment is not specifically addressed by the Division treatment guidelines or the Division treatment protocols.”

Agency Response:  The Division declines to make this recommendation.  The recommended language is unnecessary and potentially confusing.  Addition of the suggested language could lead to confusion distinguishing between medical and fee disputes.  Although treatment denied in accordance with a treatment guideline leads to denial of payment, the dispute should be processed as a medical necessity dispute and proceed according to §133.308.   

§137.100(i):  Commenters support the effective date of January 1, 2007, provided at least 45 days to implement the new treatment paradigm is available for system and process changes to occur that are necessary for compliance.

Agency Response:  The Division agrees.  The implementation date for treatment guidelines has been changed to May 1, 2007.

§137.300:  Commenters recommend added language to specify the information that should be included on a treatment plan submitted by the treating doctor and a requirement for a standard format with the inclusion of all diagnoses and associated treatments.  A commenter recommends the treatment plan should identify co-morbid conditions that affect the treatment being requested for the injury.  Commenter makes an additional recommendation to add language to §137.300 to specify the information that should be included on a treatment plan in a standardized format with all diagnoses and associated treatments.  

Agency Response:  The Division declines to make the recommended changes.  Treatment plans submitted as a result of this section are required to comply with the requirements of §134.600, which establishes the components of a complete preauthorization request.  The request shall include information to substantiate the medical necessity of the health care requested.  Additionally, a specific Division form is unnecessary as long as the requirements of §134.600(f) are met. 

§137.300:  Commenter understands and agrees that there should be a global treatment plan created and overseen by the treating physician.

Agency Response:  The Division agrees and clarifies that only required treatment plans as identified in subsection (a) must be coordinated by the treating doctor.

§137.300:  Commenter states in the initial phase, health care providers with a proven track record of achieving desired outcomes should be allowed to pursue treatment plans that have proven to be effective, particularly for patients identified as at risk for delayed recovery.  Commenter explains such necessity may modestly exceed the guidelines. 

Agency Response:  The Division disagrees.  Health care outside the guidelines requires preauthorization and in specified circumstances treatment planning through the preauthorization process.  This increases the opportunity for communication between health care providers and insurance carriers, minimizes over utilization of services and adds to surety of payment for health care providers.  

§137.300(a):  Commenters recommend a health care provider submit a treatment plan only upon the request of the insurance carrier or the insurance carrier’s utilization review program.  A commenter recommends the timeline be established at 20 days for the treatment plan submission.  Another commenter recommends a treatment plan be required once a claim becomes at risk for excessive lost time and poor return to work and recovery outcomes.  The process should be used prudently on those claims at greatest risk for poor outcomes since processing treatment plans is burdensome to the system participants.

Agency Response:  The Division disagrees.  The intent of the disability management rules is to provide tools for the efficient utilization of health care.  In order for these tools to be used consistently, criteria for the use of treatment planning is established in these rules.  Treatment planning, when conducted only at the request of the insurance carrier, would allow for vastly different standards between insurance carriers and potentially lead to additional administrative costs and confusion for health care providers.  This would defeat the purpose of establishing benchmarks for consistent use throughout the system and hinder efforts to compare and identify high performers in the system.

§137.300(a):  Commenters recommend a limit to the specified period of time that can be covered by a treatment plan.  A commenter recommends rule clarity as to the length of time the treatment plan is to cover with caution and consideration given to the expense of processing preauthorization requests.  Another commenter recommends that both this section and §134.600 should state that durations for treatment plans be no more than 30 days, as commenter believes a treatment plan should be limited to a specified time frame.  Commenter notes that §134.600(g) provides for a sixty-day time frame to request health care for treating an injury or diagnosis that is not accepted by the insurance carrier in accordance with Labor Code §408.0042. 

Agency Response:  The Division agrees that treatment plans should cover a specified time period and the language has been changed to indicate that treatment plans shall cover health care treatments and services to be provided to the injured employee for a minimum of 30 days.  Insurance carriers and health care providers may negotiate a longer time frame that is appropriate to the specific case as part of the treatment plan through the preauthorization process.  For example, a treatment plan covering an extended period of time may be appropriate for a catastrophic injury.  Communication between insurance carriers, health care providers and injured employees should lead to an effective treatment planning process minimizing inappropriate requests and/or denials.  The Division disagrees that the time period for treatment plans should mirror §134.600(g).  The treatment plans addressed by §134.600(g) serve a specific purpose related to compensability issues and the dispute resolution time frames.

§137.300(a)(1):  Commenter recommends the use of a lost time parameter as criteria for requiring treatment planning for at risk claims.  Additionally, commenter states the other criteria for requiring treatment planning are reasonable.

Agency Response:  The Division agrees that the disability management and the treatment planning process would benefit from the inclusion of a time parameter as a trigger for treatment planning.  The rule is changed to establish a treatment planning link to the optimum days listed in adopted §137.10 or 60 days from the date of injury, whichever is greater.

§137.300(a):  Commenter states the rule lacks details pertaining to amended or modified treatment plans.  

Agency Response:  The Division disagrees that additional explanation is necessary because changes or extensions of care in a preauthorized treatment plan are addressed through the concurrent review provisions of §134.600 (q)(6). 

§137.300(a):  Commenter recommends minimal duration times for specific treatment plans based on aging of claims, but allowing flexibility between treating doctor and payor to ease negotiations.

Agency Response:  The Division agrees.  The language has changed to require a treatment plan for a minimum of 30 days.  Insurance carriers and health care providers may negotiate a longer duration for a treatment plan as part of the preauthorization process.

§137.300(a):  Commenter recommends the development of an accompanying treatment planning form, which could be a modification of the DWC Form-73, to include specific treatment recommendations, CPT codes, and appropriate time frames.  Commenter states this would allow for a standardized information set and format to simplify and ease the process.

Agency Response:  The Division declines to develop an additional Division form for the submission of treatment plans.  Treatment plans submitted as a result of this section are required to comply with the requirements of §134.600 and the new sections.

§137.300(a):  Commenters recommend that in addition to specifying who is responsible, the rule specify deadlines for the submission of the treatment plan, and if the treatment plan is not timely submitted, then allow the insurance carrier to request a designated doctor exam for purposes of addressing a treatment plan.

Agency Response:  The Division declines because additional language would be duplicative of the provisions of §134.600, which establishes the required elements and time frames for submission of a preauthorization request. Treatment plans are submitted as preauthorization requests.  Other Division rules allow the insurance carrier the option of requesting designated doctor evaluations of medical care and do not require a specified time frame.

§137.300(a):  Commenters recommend the following language, “…the treating doctor is required to submit written treatment plans to the insurance carrier within ten (10) working days of receipt of a written request from the insurance carrier when…”  Commenters suggest this approach would require the treating doctor to submit a treatment plan as specified in subsection (a)(1-3) only if the insurance carrier has requested a treatment plan in writing.  Commenters state a treatment plan is not necessary in all claims in which a diagnosis is not included in the treatment or return to work guidelines, especially if there is not sufficient injury severity to support the time and expense of developing a treatment plan.

Agency Response:  The Division declines to make the recommendation to require the treating doctor to submit a treatment plan only if the insurance carrier  requests a treatment plan in writing.  The change would require the initiation of the treatment planning process only on the request of an insurance carrier.  Currently, the Division rejects this concept because treatment planning, when conducted only at the request of the insurance carrier, would allow for vastly different standards between insurance carriers and potentially lead to additional administrative costs and confusion for health care providers.  This would defeat the purpose of establishing benchmarks for consistent use throughout the system and hinder efforts to compare and identify high performers in the system.  The Division agrees that a treatment plan may not be required in all instances.  With the adoption of treatment guidelines a majority of injuries and treatment for injuries that resolve quickly are likely addressed within the treatment guidelines and would not require a treatment plan.  Additionally, language has been changed to require treatment plans in only certain circumstances.

§137.300(a):  A commenter recommends the deletion of the reference to diagnosis not addressed by the return to work guidelines in subsection (a)(2).  The commenter states a lack of diagnosis being included in the Division’s return to work guidelines is irrelevant when addressing the appropriateness and medical necessity of health care in the Texas Workers’ compensation system.

Agency Response:  The Division agrees and the reference to diagnosis not included in the return to work guidelines is deleted from subsection (a).

§137.300(a):  Commenter recommends adding in subsection (a) an additional requirement stating, “treatment plans are required when treatment is outside the optimum return to work guidelines are exceeded.”

Agency Response:  The Division agrees that criteria for required treatment plans should include a lost time reference and subsection (a) is changed to link to the adopted return to work guidelines.

§137.300(a):  Commenter recommends substitutions of “reasonably” for “all” to subsection (a) to read, “A treatment plan shall include the identification of ‘reasonably’ anticipated health care and treatment and services to be provided to the injured employee for a specified period of time.”

Agency Response:  The Division agrees in concept and the language has been changed to incorporate the language all reasonably anticipated into subsection (a).

§137.300(a):  Commenter recommends amended language to also state that treatment planning rules have been adopted to improve the quality of treatment provided to injured employees and improve return to work outcomes in the Texas workers’ compensation system, and to confirm that the rules do not apply to claims subject to workers’ compensation health care networks under Chapter 1305 of the Insurance Code.

Agency Response:  The Division declines to make the recommended change, as similar language is already included in §137.1.  The Division declines to make the modifications to the rule that reiterates the provisions of the Labor and Insurance Codes.  Labor Code, §413.011(g) provides that rules adopted relating to disability management do not apply to claims subject to workers’ compensation networks.  Workers compensation networks are required to adopt their own treatment guidelines, return-to work guidelines, and individual treatment protocols, pursuant to Insurance Code §1305.304.  Based on the specificity of the Labor Code and Insurance Code provisions, the Division believes it is unnecessary to restate such provisions in the adopted rules.  

§137.300(b):  Commenters recommend the deletion of subsection (b) and any references to it in the remaining, re-numbered subsections.  Subsection (b) as proposed would be an administrative burden for system participants. Voluntary certification, preauthorization, and concurrent review issues would be intermingled in a single treatment plan, because this treatment is already outside the treatment guidelines.  Commenters state the recommended deletion of subsection (b) would be consistent with other recommended section and subsection deletions that pertain to treatments and services or treatment plans that are presumed to be reasonable.  Submission of a treatment plan for services that are presumed to be “reasonable” and “reasonably required” adds unnecessary requirements and costs to stakeholders.  A commenter opines that §137.100(g) and §137.300(a) include provisions that address when treatment plans are required for submission to the insurance carrier for a medical necessity determination.

Agency Response:  The Division agrees to change subsection (b) and the permissive language regarding treatment planning for treatments and services within the Division’s treatment guideline is deleted.

§137.300(c):  Commenter states that when an orthopedic surgeon is not defined as the treating doctor, then communication of any denials and subsequent appeals bypass the orthopedic surgeon.  By rule, the commenter notes, the insurance carrier only needs to communicate with the treating doctor.  Commenter additionally opines that the control and management of a patient post-operatively should be clearly defined as the responsibility of the surgeon and not abrogated to the treating doctor.

Agency Response:  The Division disagrees that communication of any denials and subsequent appeals will bypass the health care provider if that health care provider is not also the treating doctor that submits the treatment plan to the insurance carrier.  However, the adopted rule added language in subsection (e) to facilitate communication between the necessary parties and provides that the treatment plan include the contact information of the health care providers involved in the delivery of care proposed within the treatment plan and requires the treating doctor to inform the health care provider(s) of the approval or denial of the treatment plan.  In addition, prior to an adverse determination by a utilization review agent and subject to notice requirements, the health care provider who orders the service submitted by the treating doctor in the treatment plan, is afforded a reasonable opportunity to discuss the plan of treatment for the injured employee with the appropriate doctor or health care provider performing the review in accordance with Insurance Code Article 21.58 A §4(k), recodified as §4201.206. 

§137.300(c):  Commenters recommend changing the rule from treating doctor to requesting doctor.  Commenters state that treating doctors may not be able to adequately support and defend preauthorization requests for specialty treatment, thereby, delaying necessary treatment to injured employees.  Commenters state this approach was previously required in the Texas workers’ compensation system and it created extreme periods of delayed recovery, inefficiencies, and disputes.  A commenter states this provision is another administrative burden upon the treating doctor and, therefore, recommends striking the language requiring a treating doctor to submit the treatment plan.  Another commenter notes the proposed rule appears to conflict with multiple utilization review regulations within the Division and TDI requiring review of service by same licensed type and/or specialty as the requestor.

Agency Response:  The Division declines to make the recommended revision.  The treating doctor is responsible for efficient and cost-effective utilization of health care as outlined in the Labor Code §§408.021(c), 408.023(l), and 408.025(c).  In order to fulfill this responsibility, treating doctors must be proactively involved in the development and support of services and treatments recommended for the early and appropriate return to work of injured employees.  The Division disagrees that there is a conflict as to §21.58A of the Insurance Code.  Insurance Code Article 21.58A §4(i), recodified as Section 4201.153(d), provides that denials of treatment must be referred to an appropriate physician, dentist, or other health care provider to determine medical necessity.  Therefore, the statute requires review of service by an appropriate health care provider, not necessarily review by a health care provider with the same type of license and/or specialty practice.  In addition, prior to an adverse determination by a utilization review agent and subject to notice requirements, the health care provider who ordered the service submitted by the treating doctor in the treatment plan, is afforded a reasonable opportunity to discuss the plan of treatment for the injured employee with the appropriate doctor or health care provider performing the review in accordance with Insurance Code Article 21.58 A §4(k), recodified as §4201.206. 

§137.300(c):  Commenters recommend revising the paragraph and offer suggested language so that the treating doctor is still required to express concurrence with the plan in writing, but once obtained, the health care provider actually rendering the service may submit their own plan directly to the insurance carrier and be the health care provider conferring with a peer if necessary to discuss the treatment plan.  One commenter offered the following recommended revision, “When a health care provider develops a treatment plan pursuant to subsection (a) or (b) of this section, it shall be submitted to the treating doctor who will indicate approval of the plan in writing.  The treating doctor or his representative shall then submit the approved plan to the insurance carrier to be processed as a preauthorization request pursuant to §134.600 of this title (relating to Preauthorization, Concurrent Review, and Voluntary Certification of Health Care).”  Another commenter’s recommendation is to seek the treating doctor’s sign-off on the proposed treatment plan that the physical therapist/occupational therapist establishes, and then that treatment plan is submitted to the insurance carrier for approval.

Agency Response:  The Division declines to make the recommended changes. §§401.011, 408.021, 408.023, and 408.025 of the Labor Code detail the responsibilities of a treating doctor. These responsibilities include the efficient management of medical care, the efficient utilization of health care, and except in an emergency, the responsibility to approve or recommend all health care.  The Labor Code clearly intends the treating doctor to be the focal point for health care provided to an injured employee.  The treatment planning process is the tool that facilitates the ability of the treating doctor to meet his or her obligations under the Labor Code.  Distributing these responsibilities to other system participants undermines the intent of the Labor Code.

§137.300(c):  Commenter recommends deleting the reference to subsections (a) and (b) as this would be consistent with other recommended section and subsection changes/deletions.  Commenter asserts it is appropriate for the treating doctor to be the point of contact for treatment plans with the insurance carriers as this is consistent with their gatekeeper role in the workers’ compensation system.

Agency Response:  The Division acknowledges the recommendation and notes that the recommendation is addressed through the revision of the section.  The section is changed and renumbered to clarify the instances requiring treatment planning and the services required for inclusion in a treatment plan.

§137.300(c):  Commenter recommends increasing the preauthorization response time to five days for treatment planning, instead of the current three-day response time in §134.600.  Commenter recommends the development of different preauthorization time frame standards for evaluating a comprehensive treatment plan.  The Division should seek additional appropriate stakeholder input on the time frames because the time frames in the preauthorization rule are not sufficient for the complexities of a treatment plan.

Agency Response:  The Division notes that a revision to the time frames included in §134.600 are outside the scope of this rule.  Addition of time frames to this rule would create a bifurcated preauthorization process and likely lead to additional administrative burdens for system participants.  Any changes to the time frames included in §134.600 will be addressed through a separate rule making activity which would include stakeholder input.

§137.300(c):  Commenter recommends a revision to allow the health care provider to submit a physician approved treatment plan or physician authorization directly to the insurance carrier; or require the insurance carrier to supply preauthorization to the physician and the involved health care providers individually.  Commenter states §137.300(c) as proposed creates an undue burden on the treating doctor and causes delays in receiving timely care.

Agency Response:  The Division declines to make the recommended changes. Labor Code §§401.011, 408.021, 408.023, and 408.025 detail the responsibilities of a treating doctor.  These responsibilities include the efficient management of medical care, the efficient utilization of health care, and except in an emergency, the responsibility to approve or recommend all health care.  The Labor Code clearly intends the treating doctor to be the focal point for health care provided to an injured employee.  The treatment planning process is the tool that facilitates the ability of the treating doctor to meet these obligations under the Labor Code.  Distributing these responsibilities to other system participants undermines the Labor Code.  The Division also disagrees that development of a treatment plan will delay timely care. Treatment planning should lead to the systematic delivery of care, more efficient utilization of services and improved return to work outcomes for injured employees.

§137.300(c):  Commenter seeks clarification as to whether the treatment plans must be approved in their entirety as submitted by the treating doctor.

Agency Response:  The Division notes that a required treatment plan is on the list of items requiring preauthorization.  Criteria for submitting and processing preauthorization requests is established in §134.600.

§137.300(c):  Commenter recommends the treating doctor be designated as a gatekeeper or coordinator of care and be reimbursed for those services.  Commenter states that if there is an issue of the treating doctor wanting control and continuity of a patient, a copy of the treatment plan submitted to the insurance carrier could be required to be submitted to the treating physician simultaneously.

Agency Response:  The Division agrees that the treating doctor has special responsibilities as required by the Labor Code and believes that the disability management concept and associated rules facilitate the treating doctor’s ability to successfully comply with those responsibilities.  Issues related to reimbursement are not directly addressed in this rule making activity but are included in §134.202 (relating to Medical Fee Guideline).

§137.300(d):  Commenter supports the effective date provided there is at least 45 days to implement the new treatment paradigm for system and process changes to occur that are necessary for compliance.

Agency Response:  The Division agrees and §§ 137.10, 137.100 and 137.300 are changed to reflect an implementation date of May 1, 2007.

5.  NAMES OF THOSE COMMENTING FOR AND AGAINST THE SECTIONS. 

For:  Work Loss Data Institute.

For, with changes: Individuals, a Legislator, American College of Occupational and Environmental Medicine, Positive Health Management, Healthcare Consulting Associates, State Office of Risk Management, American Airlines, Texas Mutual Insurance Company, Zenith Insurance Company, American Academy of Orthopaedic Surgeons, Somi Healthlink, Reed Group, Ltd., Healthsouth Corporation, Texas Association of School Boards, Insurance Council of Texas, Concentra, Inc., American Insurance Association, Flahive, Ogden & Latson, Law Offices of W.J. Bill Morris, WORK REHAB, Texas Medical Association, BIOMET, Texas Association of Business, Texas Physical Therapy Association, Office of Injured Employee Council, Physicians Cooperative of Texas, and Texas Orthopaedic Association.

Against: Individuals, Texas Association of Neurological Surgeons, and the Texas Spine Society. 

Neither For or Against:  Fair Isaac Corporation and WorkSTEPS.

6.  STATUTORY AUTHORITY.  The new sections are adopted under Labor Code §§413.011 (e), 413.011 (g), 401.011, 413.021, 409.005, 408.023, 408.025, 413.017, 413.018, 413.013, 408.021, 402.00111, and 402.061.  Section 413.011(e) provides that the Commissioner by rule shall adopt treatment guidelines and return-to-work guidelines and may adopt individual treatment protocols with specific criteria for such adoption.  Section 413.011 (g) provides that the Commissioner may adopt rules relating to disability management that are designed to promote appropriate health care at the earliest opportunity after the injury to maximize injury healing and improve stay-at-work and return-to-work outcomes through appropriate management of work-related injuries or conditions.  Section 401.011 contains definitions used in the Texas workers’ compensation system (in particular, 401.011(18-a), the definition of “evidence-based medicine,” 401.011(22-a), the definition of “health care reasonably required” and 401.011(42), the definition of “treating doctor”).  Section 413.021 requires an insurance carrier to provide the employer with return-to-work coordination services as necessary to facilitate an employee's return to employment.  Section 409.005 provides the procedure for filing a report of injury, the format to be used, authorizes the adoption of rules regarding the information that must be included in the report, and requires the employer to notify the employee, the treating doctor, and the insurance carrier of the existence or absence of opportunities for modified duty or a modified duty return-to-work program available through the employer.  Section 408.023 requires the Division to develop a list of doctors licensed in Texas who are approved to provide health care services under the Workers’ Compensation Act and authorizes the Commissioner to adopt rules to define the role of the treating doctor and to specify outcome information to be collected for a treating doctor.  Section 408.025 authorizes the Commissioner by rule to adopt requirements for reports and records, and provides that the treating doctor is responsible for maintaining efficient utilization of health care.  Section 413.017 provides that certain medical services are presumed reasonable.  Section 413.018 provides that the commissioner by rule shall provide for the periodic review of medical care provided in claims in which guidelines for expected or average return to work time frames are exceeded and the Division shall review the medical treatment provided in a claim that exceeds the guidelines and may take appropriate action to ensure that necessary and reasonable care is provided.  

Section 413.013 authorizes the Commissioner by rule to establish programs for prospective, concurrent, and retrospective review and resolution of disputes regarding health care treatments and services, for the systematic monitoring of the necessity of treatments administered and fees charged and paid for medical treatments to ensure that the medical policies or guidelines are not exceeded, to detect practices and patterns by insurance carriers, and to increase the intensity of review for compliance with the medical policies or fee guidelines.  Section 408.021 provides that an employee who sustains a compensable injury is entitled to all health care reasonably required by the nature of the injury as and when needed (specifically health care that enhances the ability of the employee to return to or retain employment) and provides that, except in an emergency, all health care must be approved or recommended by the employee's treating doctor.  Section 402.00111 provides that the Commissioner of workers' compensation shall exercise all executive authority, including rulemaking authority, under the Labor Code and other laws of this state.  Section 402.061 provides that the Commissioner of workers' compensation has the authority to adopt rules as necessary to implement and enforce the Texas Workers' Compensation Act.

7.  TEXT. 

CHAPTER 137. DISABILITY MANAGEMENT

 

SUBCHAPTER A. GENERAL PROVISIONS

§137.1.  Disability Management Concept.

            (a)  Disability management is a process designed to optimize health care and return to work outcomes for injured employees to avoid delayed recovery in the Texas Workers’ Compensation System.

            (b)  This chapter is designed to provide disability management tools, such as treatment and return to work guidelines, treatment protocols, treatment planning, and case management to benchmark, manage, and achieve improved outcomes.  The Division may use these tools for the following purposes, including, but not limited to:

(1)  resolving income benefit disputes;

(2)  resolving medical benefit disputes;

(3)  establishing performance-based tiers;

(4)  defining performance-based incentives;

(5)  determining sanctions or penalties;

(6)  performing medical quality reviews; or

                        (7) assessing other matters deemed appropriate by the Commissioner of Workers’ Compensation.

            (c)  The Division will utilize this chapter to implement and interpret specific provisions contained in Labor Code §413.011(a) and (e), and this chapter takes precedence over any conflicting payment policy provisions adopted or utilized by the Centers for Medicare and Medicaid Services (CMS) in administering the Medicare program. 

            (d)  Independent Review Organization (IRO) decisions regarding medical necessity made in accordance with Labor Code §413.031 and §133.308 of this title (relating to Medical Dispute Resolution by Independent Review Organizations), which are made on a case-by-case basis, take precedence in that case only, over adopted treatment guidelines, treatment protocols, treatment planning and Medicare payment policies.

SUBCHAPTER B.  RETURN TO WORK 

§137.10.  Return to Work Guidelines.

            (a)       Insurance carriers, health care providers, and employers shall use the disability duration values in the current edition of The Medical Disability Advisor, Workplace Guidelines for Disability Duration, excluding all sections and tables relating to rehabilitation, (MDA), published by the Reed Group, Ltd.(Division return to work guidelines), as guidelines for the evaluation of expected or average return to work time frames.

            (b)  Information on how to obtain or inspect copies of the Division return to work guidelines may be found on the Division’s website:  www.tdi.state.tx.us.

            (c)  The Division return to work guidelines provide disability duration expectancies.  The Division return to work guidelines shall be presumed to be a reasonable length of disability duration and shall be used by:

                        (1)  health care providers to establish return to work goals or a return to work plan for safely returning injured employees to medically appropriate work environments;

                        (2)  insurance carriers as a basis for requesting a designated doctor examination to resolve an issue regarding an injured employee’s ability to return to work as well as a basis to initiate case management and to refer an injured employee to vocational rehabilitation providers; and

                        (3) employers, insurance carriers, health care providers, and injured employees to facilitate and improve communications among the parties regarding the return to work goals or plans established by health care providers.

            (d)  The health care provider, insurance carrier, employer, and Division may consider co-morbid conditions, medical complications, or other factors that may influence medical recoveries and disability durations as mitigating circumstances when setting return to work goals or revising expected return to work durations and goals.

(e)  Disability duration values in the guidelines are not absolute values and do not represent specific lengths or periods of time at which an injured employee must return to work; the values represent points in time at which additional evaluation may take place if full medical recovery and return to work have not occurred.  System participants may, however, determine additional evaluation is appropriate at any time during a claim.  The disability duration values depict a continuum from the minimum time to the maximum time for most individuals to return to work following a particular injury.  An insurance carrier may request additional return to work information from a health care provider at any time.  An insurance carrier may not use the Division return to work guidelines as the sole justification or the only reasonable grounds for reducing, denying, suspending or terminating income benefits to an injured employee.

            (f)  For all diagnoses or injuries that are not addressed by the Division return to work guidelines, system participants shall establish disability duration parameters and return to work goals in accordance with the principles of evidence-based medicine as defined by Labor Code §401.011(18-a).

            (g)  This section is effective on or after May 1, 2007.

 

CHAPTER 137. DISABILITY MANAGEMENT

 

SUBCHAPTER C.  TREATMENT GUIDELINES

§137.100. Treatment Guidelines.

(a)  Health care providers shall provide treatment in accordance with the current edition of the Official Disability Guidelines – Treatment in Workers’ Comp, excluding the return to work pathways, (ODG), published by Work Loss Data Institute (Division treatment guidelines), unless the treatment(s) or service(s) require(s) preauthorization in accordance with §134.600 of this title (relating to Preauthorization, Concurrent Review and Voluntary Certification of Health Care) or §137.300 of this title (relating to Required Treatment Planning).

(b)  Information on how to obtain or inspect copies of the Division treatment guidelines may be found on the Division’s website:  www.tdi.state.tx.us.

            (c) Health care provided in accordance with the Division treatment guidelines is presumed reasonable as specified in Labor Code §413.017, and is also presumed to be health care reasonably required as defined by Labor Code §401.011 (22-a). 

(d) The insurance carrier is not liable for the costs of treatments or services provided in excess of the Division treatment guidelines unless:

                        (1)  the treatment(s) or service(s) were provided in a medical

emergency; or

                        (2)  the treatment(s) or service(s) were preauthorized in accordance with §134.600 or §137.300.

            (e) An insurance carrier may retrospectively review, and if appropriate, deny payment for treatments and services not preauthorized under subsection (d) of this section when the insurance carrier asserts that health care provided within the Division treatment guidelines is not reasonably required.  The assertion must be supported by documentation of evidence-based medicine that outweighs the presumption of reasonableness established by Labor Code §413.017. 

(f)  A health care provider that proposes treatments and services which exceed, or are not included, in the treatment guidelines may be required to obtain preauthorization in accordance with §134.600, or may be required to submit a treatment plan in accordance with §137.300.

            (g) The insurance carrier shall not deny treatment solely because the diagnosis or treatment is not specifically addressed by the Division treatment guidelines or Division treatment protocols.

            (h) This section applies to health care provided on or after May 1, 2007.

SUBCHAPTER D.  TREATMENT PLANNING

§137.300 Required Treatment Planning.  

(a)  A treatment plan shall include the identification of all reasonably anticipated health care treatment and services to be provided to the injured employee for a minimum of 30 days.  Treatment plans shall be consistent with the principles of evidence-based medicine and health care reasonably required as defined in Labor Code 401.011(18-a) and (22-a) and shall be submitted for preauthorization by the treating doctor.  Treatment plans are required when:

            (1)  treatment or service is anticipated to exceed or is not included in Division treatment guidelines or Division treatment protocols in accordance with §137.100 of this title (relating to Treatment Guidelines); and the treatment or service will be provided after the greater of:

                        (A)  60 days from the date of injury; or

                                    (B)  the optimum days listed in §137.10 of this title (related to Return to Work Guidelines);

                        (2)  a diagnosis is not included in Division treatment guidelines or Division treatment protocols; or 

                        (3)  deemed necessary by the Commissioner as a result of sanctions imposed in accordance with Labor Code §408.0231(e) and (f) and other relevant sections of this title.                       

            (b) A treatment plan is not required for treatments and services within the Division treatment guidelines or Division treatment protocols unless the treatments or services are submitted as part of a required treatment plan in accordance with subsection (a) of this section.

            (c)  When a health care provider identifies treatments and services that require preauthorization in accordance with §134.600 of this title (relating to Preauthorization, Concurrent Review, and Voluntary Certification of Health Care), the treatment or service may be submitted for preauthorization by a health care provider unless the health care is submitted as part of a treatment plan in accordance with subsection (a) of this section.

            (d) When a  health care provider develops a treatment plan pursuant to subsection (a) or (b) of this section, it shall be submitted by the treating doctor to the insurance carrier and processed as a preauthorization request pursuant to §134.600.  If the health care provider is not the treating doctor and identifies services that require a treatment plan pursuant to subsection (a) of this section,the health care provider shall confer with the treating doctor to develop the required treatment plan in accordance with subsection (a) of this section.

(e)  The treating doctor shall confer with the health care providers, insurance carriers, employers, or injured employees as necessary to develop the treatment plan.  The treatment plan shall include the identity and contact information of the health care providers involved in the delivery of care proposed within the treatment plan.

(f)  The treating doctor shall inform the parties identified in subsection (e) of this section of the approval or denial of the treatment plan.

            (g)  This section applies to health care provided on or after May 1, 2007.

 

CERTIFICATION.  This agency certifies that the adopted sections have been reviewed by legal counsel and found to be a valid exercise of the agency’s legal authority.

Issued at Austin, Texas, on _________________, 2006.

                                                            _____________________________

                                                            Norma Garcia

                                                            General Counsel

                                                            Division of Workers’ Compensation

                                                            Texas Department of Insurance

IT IS THEREFORE THE ORDER of the Commissioner of Workers’ Compensation that new  §§137.1, 137.10, 137.100, and 137.300, concerning Disability Management, are adopted.

AND IT IS SO ORDERED.

                                                _______________________________________

                                                ALBERT BETTS

                                                COMMISSIONER OF WORKERS’ COMPENSATION

ATTEST:

________________________________________

Norma Garcia

General Counsel

COMMISSIONER’S ORDER NO.______________________________________


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