BEFORE THE DEPARTMENT OF LABOR AND INDUSTRY
OF THE STATE OF MONTANA
In the matter of the adoption of NEW RULES I through V, and the amendment of ARM 24.29.1401A, 24.29.1402, 24.29.1406, 24.29.1407, 24.29.1501, 24.29.1517, 24.29.1519, 24.29.1526, 24.29.1574, 24.29.1575, 24.29.1585, 24.29.1586, 24.29.2002, and 24.29.2003, regarding the implementation of utilization and treatment guidelines and medical services rules for workers' compensation matters
NOTICE OF ADOPTION AND AMENDMENT
TO: All Concerned Persons
1. On May 12, 2011, the Department of Labor and Industry (department) published MAR Notice No. 24-29-256 regarding the public hearing on the adoption and amendment of the above-stated rules on page 728 of the 2011 Montana Administrative Register, Issue Number 9.
2. On June 6, 2011, a public hearing was held at which time members of the public made oral comments. Additional written comments were received during the comment period.
3. The department has thoroughly considered the comments and testimony received from the public. The following is a summary of the public comments received and the department's response to those comments:
Comment 1: One comment noted that the thoracic region of the spine is not covered by a specific guideline. The commenter suggested that the cervical spine injury guideline be applied to T6 or T7 and above, and the low back guideline be applied to T7 and below. The commenter also expressed concern that if there is no guideline for this region, then all treatment has to obtain prior authorization under New Rule II.
Response 1: There is no specific guideline for the thoracic region. There are references to the thoracic region in the cervical spine injury and low back guidelines. The thoracic region is to be treated as a body part without a guideline under the utilization and treatment rules, unless there is a specific reference to it in the cervical spine injury or low back guidelines. That means that providers are to follow the general guideline principles, as required by New Rule I(3)(d) (24.29.1591), for injuries to the thoracic region, and are to request prior authorization when it would normally be required under ARM 24.29.1517. Providers do not have to obtain prior authorization for all treatment, but rather, would obtain prior authorization as they do now.
Comment 2: One commenter asked if treatment performed between July 1st and July 14th would be compensable if prior authorization was not obtained before the rules go into effect on July 1. The commenter was concerned that providers could be blind-sided if they provide treatment during that time period, but didn't obtain prior authorization ahead of time.
Response 2: The rules cannot govern any issue that occurs before the effective date of the rules. If a provider wishes to provide treatment between July 1st and July 14th that would require prior authorization under the currently existing rules, the provider should obtain that prior authorization before the new rules go into effect. If the treatment would require prior authorization under the new rules, the provider may wish to delay treatment during that time period in order to obtain prior authorization.
The department believes it is important to note that there are cases that will be in the middle of treatment when the new rules go into effect. An insurer must use its discretion carefully in any case in which it has been approving treatment as reasonable that would not be allowed without prior authorization under the new rules. Insurers have the ability to allow a course of treatment to continue that was begun before the rules went into place.
Comment 3: One commenter noted there is an incorrect reference in the notice that states "ODG" stands for "Occupational Disability Guidelines," when in fact, "ODG" stands for "Official Disability Guidelines."
Response 3: The department acknowledges that the comment is correct and that the department misidentified the correct name of the ODG in the general statement of reasonable necessity. The department notes that its inadvertent misnomer does not affect the department's reasoning or rationale for its decision to not adopt ODG as part of the Montana Guidelines.
Comment 4: One commenter noted that the ODG guidelines scored higher on technical criteria than the other guidelines considered by the department, including the Colorado guidelines chosen by the department.
Response 4: The department developed an evaluation plan that requested a Montana medical provider group (MPG) to review several national guidelines and rate the guidelines for technical quality and clinical validity of the content. The MPG rated ODG slightly higher than the Colorado guidelines for technical quality but rated ODG slightly lower than the Colorado guidelines for clinical validity of the content. The Colorado guidelines scored higher in six of seven clinical scenarios reviewed by the MPG group. The MPG voted unanimously to recommend the Colorado guidelines as the primary guidelines to be established by the department. In addition to the MPG recommendation, the department also considered the availability, costs, and acceptability of a guideline to the Montana stakeholders and determined that the Colorado guidelines supplemented by the ACOEM guidelines was the most appropriate guidelines used to establish the Montana Guidelines.
Comment 5: One commenter requested that employers and insurers be allowed to cite to other guidelines in order to rebut the Montana guidelines, similar to the way injured workers, or someone on their behalf, may rebut the guidelines under New Rule II (24.29.1593), Prior Authorization.
Response 5: If a self-insured employer or insurer wishes to rebut the guidelines in order to allow an injured worker to obtain prior authorization for treatment outside the guidelines, they may do so under the rules as written. However, in contrast, if an insurer could rebut the guidelines in order to deny a treatment for which prior authorization is not needed, such a rule would defeat the point of choosing and establishing the Montana Guidelines as the standard for compensable treatment.
Under HB 334, the department is required to undertake an annual review of the guidelines with the assistance of providers. The department believes this is the proper mechanism and forum in which to consider changing or removing treatments from the guidelines as "recommended" and thereby narrowing the possible treatments that are presumed compensable.
To the extent that the commenter suggests that employers should have the independent right to rebut the guidelines, the department notes that in Montana employers (other than self-insured employers) do not have a direct role in claims handling decisions. Indeed, Montana law requires an insurer to exercise independent judgment when making claims handling decisions. With that said, however, the department recognizes that an employer and insurer should, and often do, have a common interest with an injured worker in seeing that there is a prompt return to work following an injury. Recent legislation emphasizes the need for appropriate communications among and between employers, workers, insurers, and medical providers regarding stay-at-work and return-to-work. The department concludes that under Montana law, an employer cannot be directly allowed to enter into disputes regarding the appropriateness of medical treatment provided to an injured worker.
Comment 6: Two commenters requested that the department add to the rules by providing a mechanism for giving injured workers advance notice so that they could choose to pay for treatment themselves if the treatment would not be covered under the utilization and treatment guidelines.
Response 6: A new rule like the one suggested is not possible to adopt in this notice because it would require notice to the public under another rule notice. In addition, nothing in these rules prevents an injured worker for paying for treatment themselves if they wish. Finally, such a rule would need to coordinate with the statutory provision that prevents an injured worker from having to pay for any provider charged amounts above those allowed by the fee schedule rules. The department will consider the suggestion when contemplating future changes to these rules.
Comment 7: A few commenters requested that New Rule II (24.29.1593), Prior Authorization, no longer set out procedures for verbal requests or verbal authorizations.
Response 7: The department agrees and has deleted the provisions regarding verbal requests for prior authorization and verbal authorizations. The department does not wish to discourage verbal communications with providers. Such communications can continue. Both under the originally proposed rule and the rule as adopted below, someone has to document a verbal request and a verbal authorization. If a provider does not document a verbal request, it is assumed not to have been made. If an insurer does not document a verbal authorization, the request is presumed to have been approved because it was never denied in writing during the time period provided for in the rule. The department has amended the rule as provided below.
Comment 8: One commenter, representing a specialty practice area, requested that the department adopt Colorado's rule that the independent medical review be conducted by a provider in "the same or similar specialty as would typically manage the medical condition" under review. Two commenters, also representing two specialty practice areas, requested that under the independent medical review process in New Rule III (24.29.1595), the language be changed from "may" to "should" so that the medical director would be required to consult with another chiropractor if a chiropractor was the designated treating physician in a case, or other applicable specialty practitioner.
Response 8: HB 334 requires the department to hire a medical director. If the medical director recuses himself or herself, does not feel qualified to review a case, or is otherwise unavailable, the department has the ability to designate a different person on a given case. The language reads: "the medical director is the specific individual designated by the department to serve as the medical director with respect to a given set of disputed treatments or procedures." Because the Legislature specifically directed the department to hire a medical director for this process, the department believes the structure of this rule allows sufficient flexibility to address cases as needed.
In addition, the department does not believe it is necessary or proper at this time for the medical director to consult a specialist in every case. One of the main purposes of the independent medical review process is to determine if the treatment that was requested and denied falls within the general guideline principles. It is not always necessary to consult a specialist for this determination. The department also believes that in light of the short timelines for providing a response to a request for the independent medical review process, and the department's desire to provide as prompt a review as is feasible, New Rule III (24.29.1595) should continue to allow the medical director the discretion of whether or not to consult with a chiropractor or other specialist. The department also notes that the suggested change from "may" to "should" would not impose a requirement for the medical director to make such a consultation, in that "should" is merely a term of advice, rather than a term of mandate like "shall." The department concludes that its medical director will have the discretion to exercise appropriate judgment in deciding which cases it is appropriate to consult with a consulting specialist, rather than requiring that such a consultation be made in every situation.
Comment 9: One commenter notes that the guidelines are designed such that certain requirements need to be met prior to initiating additional treatment. The commenter requested the department clarify that a provider may not automatically use any treatment that is designated as recommended in the guidelines. The commenter wants to make clear that when less complex or less expensive alternatives that are also recommended in the guidelines have not been used, a provider must follow those alternatives first. The commenter wanted the language to indicate that the guidelines are to be followed in a step by step manner. The commenter requested that New Rule I (24.29.1591) be changed by adding in (3)(a), "and treatment is provided in accordance with the guidelines," adding a new (b)(i) which would read "not in accordance with the guidelines;" and in New Rule II(1) (24.29.1593), adding a new (a) that would read, "are not in accordance with the guidelines;".
Response 9: The department agrees that the guidelines are to be administered in a progressive manner and that the guidelines are designed such that certain requirements need to be met prior to initiating additional treatment. Less invasive, simpler, and less costly treatments are to be followed before more complex and expensive alternatives. The guidelines are all written in this progressive step-by-step manner. Further, the general guideline principles also indicate that this is the very nature of the guidelines. A provider is not to proceed to more complex treatments unless the clinical indications are present. And nothing in the guidelines requires that all treatments recommended be provided.
The department agrees with some of the suggested language and disagrees with some. The department has amended the rule as provided below.
Comment 10: One commenter stated that it interprets the language of 39‑71‑704(3)(c), MCA, to require the independent medical review process to be used, prior to mediation, once New Rule III (24.29.1595) is in place.
Response 10: The department agrees with this interpretation to the extent the independent medical review process is requested prior to mediation. However, to the extent that the commenter suggests that the independent medical review process is a prerequisite to requesting mediation concerning a medical treatment dispute, the department disagrees that the statute imposes such a requirement. The department has amended the rule to clarify its interaction with mediation.
Comment 11: One commenter requested that the last sentence of New Rule III(3) (24.29.1595) be deleted. The commenter believes there could be unintended access issues to medical providers if a provider with whom the medical director consults is not allowed to testify in later litigation.
Response 11: The department believes it would not be proper for a consulting physician in a mediation type process to be required to testify in a later court proceeding. The department believes the proper mechanism to prevent access issues is for the medical director to use care in selecting individuals for consultation, such that there continues to be access to qualified providers if a case proceeds to litigation. The department is concerned that making an independent consultant subject to being compelled to give testimony would limit the willingness of providers to consult with the department's medical director. The department notes that nothing in the rule prevents the provider from later providing services to the injured worker, and that the rule would not prevent the provider from giving testimony related to that care. The department concludes that it should not delete the last sentence of New Rule III(3) (24.29.1595).
Comment 12: One commenter felt there was a conflict in the definition of medical director that could be construed to mean the medical director could only review issues of prior authorization regarding treatments not recommended in the guidelines and could not review, for example, issues regarding body parts not covered by a guideline.
Response 12: The department agrees with the suggested language and has amended the rule as provided below.
Comment 13: The Montana Optometric Association requested that optometrists be added in the eye guideline chapter to ophthalmologists, as professionals that general practitioners can refer patients to for treatment. The association points out optometrists are readily accessible to injured workers in Montana and it is well within the education and practice of scope of optometrists to diagnose, treat, and manage eye injuries.
Response 13: The department agrees that optometrists should be allowed to provide treatment for an injury to the eye that needs more care than can be provided by the primary care physician (provided that the care falls within the allowed scope of practice of the optometrist). The department has added optometrists as a professional that general practitioners can refer patients to for eye issues related to a workers' compensation matter. These changes are in the final guidelines that are available on June 23 and applicable to treatment provided on or after July 1, 2011.
In addition, the department has amended the text of the eye chapter of the guidelines, section C.1, General Approach and Basic Principles of Eye Injury by adding the following text: "Whenever this chapter suggests referral to an ophthalmologists, the primary care physician may refer the patient to an optometrist for care, if in the clinical judgment of the primary care physician, the injury can be treated by an optometrist. A primary care physician may also refer the patient to an optometrist to determine whether appropriate treatment can be rendered by an optometrist."
Comment 14: One commenter asked the following question: If a CPT code search in the U & T guideline's web tool does not return a result, does that mean pre-authorization is required for that treatment?
Response 14: Pre-authorization is not necessarily required when a CPT numeric code search in the web tool does not return a result. The department included some numeric CPT codes and ICD-9 codes as a customer courtesy in the web tool; however, the web tool does not include every possible CPT code or ICD-9 code that may be recommended in the content of the guidelines. If a search by CPT or ICD-9 code reveals no results, the department strongly suggests that users search by the text description to determine if the procedure: (a) is recommended or not recommended; or (b) prior authorization is required because the procedure is either not addressed in the guidelines or the guidelines require prior authorization for the specific procedure.
Comment 15: One commenter suggested that the language in proposed New Rule V(4) (24.29.1596), which refers to the meaning of the term injuries as including occupational diseases for "this rule", should be amended to clarify that the meaning applies to all of ARM Title 24, chapter 29, subchapters 14 and 15.
Response 15: The department agrees with the comment and has amended the rule as suggested and as set out below.
Comment 16: One commenter suggested that the department consider including a recommendation for referral of low back pain patients (and patients with other types of injury) found to have a history of depression, anxiety, and/or other psychiatric disturbance at the time of the initial history and physical examination for psychological screening and/or examination as a part of the initial evaluation process, as is currently recommended in the low back pain guidelines in the presence of three or more Waddell signs, rather than waiting for 6 to 12 weeks to initiate an interdisciplinary approach to evaluation and treatment.
Response 16: One purpose of waiting on an immediate psychological evaluation, unless there are certain indications, is to allow time to determine if there are any psychological conditions impeding the healing progress of the injury or occupational disease. Immediate referral in all cases described in the comment would imply that the workers' compensation insurer must be responsible for treatment of all psychopathology in injured workers. The department does not believe the suggested change is necessary at this time. The department believes it is more appropriate to consider this request as part of the annual review process after the rules have been in place.
Comment 17: Numerous commenters indicated their support for the utilization and treatment guidelines.
Response 17: The department acknowledges these comments.
Comment 18: One commenter suggested that the language of New Rule II(6) (24.29.1593) be changed to be consistent with the language of 24.29.1593(4) regarding the information used to rebut the Montana Guidelines. The commenter suggested an insurer be required to explain why a justification from a provider is not sufficient, rather than explain the reason for a denial.
Response 18: The department agrees with making the language internally consistent and has amended the rule as indicated below.
Comment 19: One commenter requested that New Rule II(4)(f) (24.29.1593) be deleted in its entirety. The commenter believes that allowing other guidelines to be used to rebut the Montana Guidelines will defeat the purpose of the guidelines, will be a justification to treat outside the guidelines, and defeats what the Medical Provider Group recommended and the declared basis for the recommendation – standardized best practices evidence-based medical treatment of injured workers. The commenter believes the preceding subsections (a)-(e) in the rule provide sufficient basis for deviation in those instances where other treatment options should be considered.
Response 19: The department disagrees that the use of other guidelines defeats the purpose of standardizing best practices evidence-based medical treatment of injured workers. The proposed rule only allows use of other guidelines if the Montana Guidelines don't recommend the treatment, the treatment is not addressed, or the guidelines require prior authorization. If a medical provider or an injured worker wishes to obtain prior authorization for a treatment not recommended by, required by, or outside the guidelines, the use of other guidelines as documentation to support authorization is reasonable. The use of additional guidelines alone will not be sufficient to rebut the guidelines. The foundation of evidence-based guidelines is to look to the evidence supporting a treatment. To the extent that someone submits another guideline to rebut the Montana Guideline, that rebuttal will only be as effective as the soundness of the evidence gained for that guideline through the scientific method, as indicated by the definition of "evidence-based " in ARM 24.29.1401A.
Comment 20: One commenter requested that the department adopt a process for reviewing and updating the Montana Guidelines that includes input and involvement from Montana physicians. The commenter requested that the process be open, transparent, and provide for input specifically from physicians in appropriate specialties.
Response 20: The department agrees. Under HB334, the department is required to undertake an annual review of the guidelines with the assistance of providers. The department believes this is the process the department will use to update and renew the Montana Guidelines. If the department determines changes are needed to the guidelines as a result of this process, the department will undertake a formal rules promulgation process with public comment as required by the Montana Administrative Procedure Act.
Comment 21: One commenter noted that the list of information allowed to rebut the guidelines in New Rule II(4) (24.29.1593) doesn't expressly allow a treating physician to present information regarding their personal clinical experience with other similar patients who have benefited from the proposed treatment or procedure. The commenter believes information of this nature should be accepted and given equal consideration with the remaining information categories. This commenter also stated that the definition of "evidence-based" in ARM 24.29.1401A is inconsistent with what the Medical Provider Group members expressed regarding their desire to consider their own practice experience in developing treatment plans for Montana's injured workers. The commenter recommended different language be used to define "evidence-based".
Response 21: The department believes that to the extent a provider wants to present information on their personal clinical experience, that information must be submitted in the context of the categories listed in the rule. Because the guidelines are intended to be evidence-based as that term is defined by rule, the department believes that allowing the treating physician to present only their personal clinical experience would defeat the purpose of the guidelines. Rather, the approach of evidence-based guidelines is the integration of individual clinical expertise with the best available external clinical evidence from systematic research. However, there is nothing in the rule that prevents a provider from indicating that their personal clinical experience supports the information being submitted to rebut the guidelines. While the Medical Provider Group discussed providers submitting personal clinical experience, the group clearly supported the goal of adopting evidence-based utilization and treatment guidelines.
4. The department has adopted the following rule as proposed: New Rule IV (ARM 24.29.1599).
5. The department has amended the following rules as proposed: ARM 24.29.1402, 24.29.1406, 24.29.1407, 24.29.1501, 24.29.1517, 24.29.1519, 24.29.1526, 24.29.1574, 24.29.1575, 24.29.1585, 24.29.1586, 24.29.2002, and 24.29.2003.
6. The department has adopted the following rules as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:
NEW RULE I (24.29.1591) UTILIZATION AND TREATMENT GUIDELINES
(1) and (2) remain as proposed.
(3) When providing treatment for primary and secondary medical services to an injured worker, all health care providers shall use the Montana Guidelines adopted by reference in (1).
(a) In cases where treatment(s) or procedure(s) are recommended by the Montana Guidelines, and treatment is provided is accordance with the guidelines, prior authorization is unnecessary unless the Montana Guidelines specify otherwise.
(b) through (5) remain as proposed.
AUTH: 39-71-203, 39-71-704, MCA
IMP: 39-71-704, MCA
NEW RULE II (24.29.1593) PRIOR AUTHORIZATION (1) through (4) remain as proposed.
(5) All prior authorization requests, whether in written,
telephone, e-mail, or facsimile (fax) form, must be made at least 14 days prior to the date the service is scheduled to be performed. If the prior authorization request was made by telephone, the burden of proof for showing that the request was made rests with the interested party who made the request.
(a) Authorization is presumed to be given by the insurer if there is no written denial sent by the insurer to the interested party within 14 days of
either the date the verbal prior authorization request was made or the date the written prior authorization request was mailed made.
(b) An insurer may notify the interested party of authorization by written confirmation,
telephone, e-mail, or facsimile (fax). If an insurer provides authorization by telephone, the burden of proof for showing that authorization was granted rests with the interested party. The interested party shall promptly send the insurer written confirmation of any verbal authorization made by the insurer. Such written confirmation shall refer to the name of the claimant, the claim number, the treatment(s) or procedure(s) authorized, and the name of the person giving the authorization and the date the authorization was given.
(c) Nothing in this rule precludes verbal communication. However, all deadlines in this rule must be satisfied in written form.
(6) If the insurer denies the prior authorization request, the denial must be in writing and must contain an explanation of
the reason(s) for the denial why the justification is not sufficient.
(a) through (8) remain as proposed.
AUTH: 39-71-203, 39-71-704, MCA
IMP: 39-71-704, MCA
NEW RULE III (24.29.1595) INDEPENDENT MEDICAL REVIEW PROCESS
(1) An interested party who has requested and been denied authorization by the insurer for treatment, or an insurer, may request an independent medical review by the medical director designated by the department prior to mediation under 39-71-2401, MCA.
A request for medical review is not mandatory in order to proceed to mediation. If the independent medical review process is requested prior to mediation, the mediation process shall not proceed until completion of the independent medical review process.
(2) through (8) remain as proposed.
AUTH: 39-71-203, 39-71-704, MCA
IMP: 39-71-224, 39-71-704, 39-71-2401, MCA
NEW RULE V (24.29.1596) APPLICABILITY OF UTILIZATION AND TREATMENT RULES (1) through (3) remain as proposed.
(4) As used in
this rule ARM Title 24, chapter 29, subchapters 14 and 15, the term "injuries" includes occupational diseases which were diagnosed as an occupational disease, or should have been diagnosed as an occupational disease, during the time period specified.
AUTH: 39-71-203, 29-71-704, MCA
IMP: 39-71-704, MCA
7. The department has amended the following rule as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:
24.29.1401A DEFINITIONS As used in subchapters 14 and 15, the following definitions apply:
(1) through (21) remain as proposed.
(22) "Medical director" means a person who is an employee of, or contractor to, the department, and who is responsible for the independent medical review of requests for treatment(s) or procedure(s)
that are not specifically addressed or recommended by the Montana Guidelines, when those requests are denied, and whose responsibility will also include other areas to be determined by the department. A person serving as a medical director must be a physician licensed by the state of Montana under Title 37, chapter 3, MCA.
(23) through (41) remain as proposed.
AUTH: 39-71-203, MCA
IMP: 39-71-116, 39-71-704, MCA
/s/ MARK CADWALLADER /s/ KEITH KELLY
Mark Cadwallader Keith Kelly, Commissioner
Alternate Rule Reviewer DEPARTMENT OF LABOR AND INDUSTRY
Certified to the Secretary of State June 13, 2011