PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:

Amendment of sections 300.23(d), 325-1.2, 325-1.3, 325-1.4 and 325-1.24; addition of Part 324 and section 325-1.25; and repeal of section 325-1.6 of Title 12 NYCRR.

Medical Treatment Guidelines.

Requires use of Medical Treatment Guidelines to treat neck, back, knee & shoulder, and provides processes surrounding such use.

The proposed adopts and mandates the use of treatment guidelines for workers' compensation injuries or illnesses to the neck, back, shoulder, and knee, and amends other provisions to support the guidelines.

Section 300.23(d) is amended to state that it does not apply when a request for a variance is denied.

A new Part 324 is added to Subchapter C regarding Medical Treatment Guidelines.

Section 324.1 defines relevant terms used in this Part including "Maximum Medical Improvement," "Medical Treatment Guidelines," "Review of Records," and "Treating Medical Provider."

Section 324.2 mandates treatment in accordance with the Medical Treatment Guidelines for the mid and low back, neck, knee, and shoulder, which are incorporated by reference, for all work related injuries or illnesses on an after December 1, 2010, regardless of the date of accident or date of disablement. Establishes a list of pre-authorized procedures pursuant to Workers' Compensation Law § 13-a(5), which includes all medical care consistent with the Medical Treatment Guidelines except for 12 treatments or procedures. Provides that variances from the Medical Treatment Guidelines are only allowed as provided in § 324.3.

Section 324.3 sets forth what is required to request a variance, that the burden of proof is on the treating medical provider that a variance is medically necessary and appropriate, the requirements related to a response to a variance, including the time period in which a response must be made, and how denials of variances are resolved.

Section 324.4 sets for an optional prior approval process whereby a treating medical provider can request approval from the insurance carrier or Special Fund that the treatment is consistent with the Medical Treatment Guidelines before it is performed. This section establishes how providers can opt-in to the program and makes a request, how insurance carriers can opt-out of the process, how insurance carriers who participate respond to a request, and how denials are resolved.

Section 324.5 provides that if the Medical Treatment Guidelines do not address a condition, treatment or diagnostic test for a part of the body covered by the Medical Treatment Guidelines, then the factors in necessary to request a variance shall be used to determine whether the insurance carrier or Special Fund is obligated to pay for the medical care at issue.

Section 324.6 requires insurance carriers and Special Fund to incorporate the Medical Treatment Guidelines and relevant regulatory provisions into their policies, procedures, and practices, and certify that this has been completed within 120 days of the effective date of Part 324.

Section 325-1.2 is amended to require specialists and consultants to file the same medical report forms used by treating providers.

Section 325-1.3 is amended to require medical reports of attending physicians be filed on the correct version of the form or forms prescribed by the chair for such purpose and that medical reports must be filed when a follow-up visit is necessary except the time between follow-up visits cannot exceed 90 days.

Section 325-1.4 regarding prior authorization for special services is amended to clarify and modify the procedure so it reflects the procedures actually used currently, make clear the ability of physical and occupational therapists to request prior authorization, clarify when prior authorization is necessary when multiple special services are to be performed, and incorporate the pre-authorized list from Section 324.2(d) of this Title.

Section 325-1.6 is repealed.

Section 325-1.24 is amended to limit its applicability to bills for medical services provided on and after October 1, 1994, and before December 1, 2010.

Section 325-1.25 is added to set forth the process for the submission of medical bills, the time in which medical bills must be paid and/or objected to, the objections that can be raised, and the resolution of objections.

Nonsubstantive changes were made in sections 324.1(c), (g), 324.2(a), (b), 324.3(a), (b), (d), 324.4(d), (h), 324.5, 325-1.3(b), 325-1.4(a), (b), (d) and 325-1.24 and 325-1.25.

Cheryl M Wood, NYS Workers' Compensation Board, 20 Park Street, Room 400, Albany, New York 12207, (518) 408-0469, email: [email protected]

1. Statutory Authority:

Workers' Compensation Law (WCL) § 117(1) authorizes the Chair to make regulations consistent with the WCL and the Labor Law. WCL § 141 authorizes the Chair to enforce all provisions of the chapter and make administrative regulations.

WCL § 13 establishes employer liability for medical treatment and authorizes the Chair to establish a fee schedule for medical treatment. The Chair's authority to establish a fee schedule forms the basis for Medical Treatment Guidelines (Guidelines) which set the standards of appropriate treatment.

WCL § 13-b requires individuals providing medical care or conducting independent medical examinations (IMEs) of claimants to be authorized by the Chair, except for six enumerated exceptions. The Chair has the authority to temporarily suspend or revoke a physician's authorization to treat or conduct IMEs. WCL §§ 13-k, 13-l, and 13-m, respectively, allow the Chair to authorize podiatrists, chiropractors, and psychologists to treat and/or conduct IMEs, and to temporarily suspend or revoke their authorizations.

WCL § 13-a(5) requires prior authorization from the carrier for special procedures costing more than $1,000, increased by Chapter 6 of the Law of 2007 from $500. A denial by the carrier must be within 30 days and must be based upon a conflicting second opinion rendered by an authorized physician. The 2007 reform legislation also added a provision directing the Chair to issue a list of pre-authorized procedures costing over $1,000.

Although the statutes do not specifically require the adoption of guidelines, it is clear that the absence of them has resulted in an inefficient system. Because all medical practitioners do not have consistent, up-to-date standards on which to base treatment, claimants may not be receiving the high quality care they deserve. Further, with no agreed upon standards on which to assess medical necessity, costly disputes and unnecessary treatment delays occur. In his oversight of oversight of the workers' compensation system, the Chair has an obligation to recommend procedures to rectify these problems. These guidelines should help to do so.

2. Legislative Objectives:

The purpose of the reform in chapter 6 of the Laws of 2007, effective March 13, 2007, was to increase benefits and improve delivery of services to injured workers while reducing costs. By letter dated March 13, 2007, the Governor directed the Superintendent of Insurance, with the assistance of the Board's Chair and the Commissioner of Labor, to design guidelines to account for modern diagnostic and treatment techniques and evidence-based standards of medical treatment in order to minimize litigation conflicts and speed return to employment. The Governor appointed an Advisory Committee of respected individuals in the industry to assist the Superintendent and who recommended to him proposed treatment guidelines for the shoulder, knee, neck, and back injuries that all providers would be required to use when treating injuries to those body parts. The Superintendent then recommended them to the Chair.

The goals of the Medical Treatment Guidelines (Guidelines) are three fold:

1. Improve the quality of treatment;

2. Improve the speed of delivery and reduce friction costs; and

3. Eliminate unnecessary medical treatments which do not contribute to a positive outcome.

These goals are consistent with the legislation and the Governor's directive in that they facilitate delivery of quality medical treatment to injured workers and provide a structure for that treatment based upon evidence-based standards and best practices.

WCL § 13-a(5), as amended by Chapter 6, increases the prior authorization threshold and requires a list of pre-authorized procedures. The pre-authorized list allows the Board appropriate regulatory flexibility to add or remove procedures depending on best practices, increases or decreases in costs, or various managed care approaches.

3. Needs and Benefits:

Because New York does not currently have treatment guidelines, all New York practitioners do not have up-to-date standards for the treatment of occupational injuries to the knee, shoulder, back and neck, which account for approximately 36% of the claims but nearly 60% of medical costs. Similarly, insurance carriers, self-insured employers, and the State Insurance Fund ("carriers") do not have standards to assess the medical necessity of treatment, which results in disputes over treatment, delayed care, and increase frictional costs.

The Guidelines set the standard of treatment. Carriers will only pay for treatment consistent with the Guidelines or approved through a variance process. The Guidelines create criteria for timing and use of diagnostic testing and treatments, and controls utilization of some significant cost drivers such as chiropractic manipulations, physical therapy modalities, MRIs, therapeutic injections, and nerve blocks injections. It also places limitations on 12 procedures that are subject to abuse or are complex and invasive. It prohibits ineffective treatments such as use of Medex machines and electro-analgesic nerve blocks.

In other states, treatment guidelines have significantly reduced medical costs. In California, a 24 visit cap on chiropractic and physical therapy decreased chiropractic costs by 72% and physical therapy costs by 58% in 18 months.

The Guidelines will benefit participants by improving the quality of care. Treatment guidelines, grounded in evidence-based medicine and the sound clinical judgment of highly credentialed physicians, is a useable and practical tool for stakeholders.

Without treatment guidelines, biases may affect determinations of medically necessary care to the claimant's detriment. While denial of care to reduce costs is harmful, overuse of medical services does not necessarily improve outcomes. Treatment guidelines minimize the effects of bias by addressing sound treatment practices, providing better care at lower cost.

Carriers use utilization management to assess appropriateness of care to control costs and ensure quality. However, lack of uniformity in UR standards may lead to variations in the treatment and adds frictional costs by producing needless disputes.

Uniform UR standards based on treatment guidelines should significantly reduce variation in treatment, increase the transparency of the medical claim and payment process, lead to decisions based on sound, evidence-based medicine, and reduce disputes. When disputes do arise, adjudicators will have a standard to resolve them.

Instances will occur where the Guidelines are not appropriate for a particular claimant. In such situations the treating medical provider may request approval for a variance by submitting information on the form prescribed for this purpose. The burden of proof for a variance is on the claimant and treating medical provider. Carriers have 30 days to review the request and respond. If the variance is denied, and the claimant requests review of the denial, a determination will be made at an expedited hearing or, if both the claimant and the carrier agree in writing, by a medical arbitrator appointed by the Chair. If the dispute is resolved by a medical arbitrator, there is no further appeal. The variance process provides flexibility to ensure that claimants receive necessary care.

All the treatments outlined in the Guidelines comprise the pre-authorized list, except for 12 procedures which are subject to abuse or are complex and invasive. By adopting the Guidelines as the standard of care for the neck, back, shoulder, and knee, and making all but 12 procedures pre-authorized, medically sound, evidence based treatment will flow promptly which will improve recovery and expedite a return to work.

4. Costs:

The proposed rule will impose some additional costs on the regulated parties, the Board, the State, and local governments which are expected to be offset by the savings from use of the guidelines. Medical professionals, insurance carriers, self-insured employers, third party administrators, and the Board will be required to incorporate the guidelines into their procedures. Costs will vary depending on current practices, size of the entity, familiarity with and use of any treatment guidelines.

The Board will provide training on the Guidelines to stakeholders at no cost. Copies of the Guidelines will be available on the Board's website free of charge. The cost of a hard copy is $10.00 per guideline or $5.00 for a compact disc of the four Guidelines.

Treating providers will incur some cost when requesting a variance due to the need to complete the required form. Upon receiving a variance request, the carrier has the option of having it reviewed by its own medical staff, or seeking an IME opinion. If the carrier does not believe the variance request meets the burden of proof required, it may deny the variance request without a medical opinion; however, for all other denials a medical opinion is necessary. Carriers will incur the costs if an IME or records review is obtained. The cost, however, will be offset by a reduction in IMEs due to the pre-authorized list.

If a variance is denied, the issue will be resolved at an expedited hearing or, if both parties consent, by a medical arbitrator. Parties will incur costs if the denial is resolved through the hearing process; however, these costs should be offset by the reduction in the number of denials. If the parties opt to use the medical arbitrator, the costs are nominal because there is no testimony or administrative appeal.

There will be some cost for providers who opt-in and those providers who do not opt-out of the optional prior approval process. This process provides an opportunity for the treating provider to seek the carrier's agreement, prior to providing treatment. If the carrier agrees that the treatment is consistent with the Guidelines, the provider can treat and bill, knowing that the carrier will not object. Providers will have costs associated with completing the optional approval form, and carriers will have costs associated with their responses. However, the cost is offset by the savings to the provider generated by prompt payment and fewer disputes. Carrier costs are offset by savings from eliminating the need for hearings to resolve treatment disputes.

Use of the Guidelines means that providers and carriers employ the same standards to determine if medical treatment is necessary, resulting in fewer disputes over medical bills which reduces costs and speeds payment. The pre-authorized list reduces delays in treatment and improves medical outcomes.

Use of the Guidelines is expected to result in millions of dollars of savings by eliminating unnecessary and excessive treatments and therapies which will offset any additional costs.

Except for adjustments to the proper fee schedule amount, the rule requires carriers to file with the Board on a prescribed form their valuation objections to medical bills. This submission will diminish disputes over whether an objection was filed and the timeliness of the objection. There will be nominal costs associated with filing the form which can be faxed, emailed, or filed by regular mail.

5. Local Government Mandates:

The rule only imposes a mandate on local governments that are self-insured or that own and/or operate a hospital. Those entities will need to comply with the requirements in the rule the same as a private self-insured employer or insurance carrier or private hospital.

On and after October 18, 2010, the rule requires that all claimants with injuries to the neck, back, shoulder, and/or knee be treated in accordance with the Guidelines. Self-insured local governments will be required to incorporate the Guidelines into their practices and certify that this has been done. Local governments who are self-insured will be required to pay for medical treatment that is consistent with the Guidelines, to respond to variance requests and to optional prior approval requests if they do not opt-out. Physicians employed by public hospitals will be required to use the Guidelines to treat injured workers, to request a variance, and follow all of the other rules.

6. Paperwork Requirements:

Treating medical providers, carriers, the State Insurance Fund, claimants, and others will have new paperwork requirements. Submissions relating to the Guidelines are on prescribed forms. Variance requests and responses, and requests for review of a denial and the election to opt-in to the medical arbitrator process require the use of one form. For those participating in the optional prior approval process, the requests and responses require the use of one form. Use of prescribed forms ensures easy in identification and processing.

In addition to the two new forms, the regulations require use of three existing forms.

Carriers are required to certify that they have incorporated the Guidelines into their procedures. If they modify their practices, they must re-certify that the Guidelines are still incorporated.

7. Duplication:

The proposed regulation does not duplicate or conflict with any state or federal requirements.

8. Alternatives:

The Board shared a draft of the regulations with the AFL-CIO, Business Council of New York State, State Insurance Fund, New York Insurance Association, American Insurance Association, Property Casualty Insurers Association of America, Medical Society of the State of New York, New York Conference of Mayors, New York State Association of Counties, and the Association of Towns of the State of New York, and requested comments. With respect to the Guidelines, the Board solicited comments between August 13, 2009, and September 9, 2009. The Board's Medical Director reviewed the comments and incorporated some changes.

There are no practicable alternatives to adopting treatment guidelines. Currently, the Board has no treatment guidelines, which does not lend itself to uniform standards of quality treatment and containment of costs. A uniform system will encourage proper and timely treatment, and reduce unnecessary litigation and delay.

The rule provides that all treatment consistent with the Guidelines costing more than $1,000, except for twelve procedures, is on the pre-authorized list. An alternative would be to not put medical care over $1,000 on the pre-authorized list and require prior authorization. This was rejected because it is impedes the delivery of care. Twelve procedures still require prior authorization because they are complex or high risk, invasive, or subject to abuse.

An alternative would be to require strict adherence to the Guidelines without the possibility of a variance. The ability to vary from the guidelines is necessary because claimants are different and all injuries do not always progress the same. Without a variance, some claimants would not receive the best medical care.

An alternative would be to have all denials reviewed by the Medical Director or medical arbitrator. However, as there is no statutory authority for such option, the rule allows the parties to opt-in to the arbitration process.

The rule requires that the claimant request review of the denial of a variance. An alternative would be to automatically schedule an expedited hearing, or if the parties both opt-in, to refer the dispute to the medical arbitrator, without any further action by the claimant or carrier. This alternative was not chosen because the claimant may not want to proceed with the variance request and undergo that specific procedure.

Another alternative would be to eliminate the optional prior approval process. However, the pilot survey shows that the process improves communications and reduces bill disputes.

The rule amends § 325-1.3 to increase the time between the submission of medical reports from forty-five days to ninety days. An alternative would be to leave the time period at forty-five days. However, by requiring reports only when a medically necessary visit is required, but no more than ninety days apart, fewer unnecessary office visits will be scheduled and costs reduced.

Another alternative would be to require that the prescribed form be used for all valuation objections. Originally, the rule had such a requirement, but the rule was changed to exempt objections that merely adjust the fee so that it reflects the appropriate fee schedule.

9. Federal Standards:

No federal standards are applicable to this proposed regulation.

10. Compliance Schedule:

The effected date of the regulation has been changed to December 1, 2010, from the original date of October 18, 2010, to provide participants with two additional months to comply with the regulation and take the training. This change was made based upon comments from some participants that the extra time was needed.

A revised Regulatory Flexibility Analysis for Small Business and Local Governments is not required because the changes made to the last published rule do not necessitate revision to the previously published document. The changes to the text are not substantial, do not change the meaning of any provision and therefore do not change any statements in the document. Specifically the changes are to: 1) change the effective date to December 1, 2010; 2) correct typographical errors; 3) add clarifying language; and 4) reword provisions noted as being unclear in the comments on the proposed regulation to ensure that they are clearly understood.

A revised Rural Area Flexibility Analysis is not required because the changes made to the last published rule do not necessitate revision to the previously published document. The changes to the text are not substantial, do not change the meaning of any provision and therefore do not change any statements in the document. Specifically the changes are to: 1) change the effective date to December 1, 2010; 2) correct typographical errors; 3) add clarifying language; and 4) reword provisions noted as being unclear in the comments on the proposed regulation to ensure that they are clearly understood.

A revised Statement in Lieu of Job Impact Statement is not required because the changes made to the last published rule do not necessitate revision to the previously published document. The changes to the text are not substantial, do not change the meaning of any provision and therefore do not change the statement that the rule making will not have an adverse impact on jobs. Specifically the changes are to: 1) change the effective date to December 1, 2010; 2) correct typographical errors; 3) add clarifying language; and 4) reword provisions noted as being unclear in the comments on the proposed regulation to ensure that they are clearly understood.

The Chair and Board received approximately 3,196 formal written comments. Approximately 3,110 were form letters from four groups: 1) chiropractors; 2) physical therapists; or 3) individuals stating they were claimants either receiving chiropractic or physical therapy treatment. The remaining 86 comments were submitted by associations representing business, insurance carriers, and medical providers, as well as one law firm, a labor union, individuals, medical professionals, and businesses.

All of the comments received were reviewed and assessed. The comments break down into three groups: 1) those addressing the regulations; 2) those addressing the medical treatment guidelines incorporated by reference; and 3) the form letters. The full Assessment of Public Comment summarized, analyzed, and responded to the comments received and it exceeds 2,000 words. This document is a summary of the full Assessment of Public Comment. A copy of the full assessment is posted on the Board's website at http://www.wcb.state.ny.us/content/main/wclaws/newlaws.jsp.

The comments on the regulations included numerous requests to delay the effective date of the regulations and the Guidelines, clarify provisions that were not interpreted the same by all readers, clarify provisions by explicitly stating black letter law implied by the provisions, and correct typographical errors. The following changes were made to the regulations: 1) a colon was added to the definition "Insurance carrier or Special Fund's medical professional" in § 324.1(c); 2) "subpart" was changed to " part" in the definition of "Medical Treatment Guidelines in § 324.1(g); 3) changed the date from "October 18, 2010" to "December 1, 2010" in §§ 324.2(a), 325-1.24, and 325-1.25; 4) clarified in § 324.2(b) that the fee for copies of the Guidelines must be included with request for the Guidelines, corrected the address where to send the request, clarified that the email address and telephone number are for information about the Guidelines as the fee cannot be sent with an email and the request must be in writing, and clarified that checks must be made payable to Chair, WCB; 5) clarified § 324.3(a)(1) by adding a statement that a variance is needed when treatment is not recommended by the Guidelines; 6) corrected the cite in § 324.3(b)(2)(i)(c) and in § 324.5; 7) clarified in § 324.3(b)(2)(ii)(a) that the only required action within five business days is to notify the chair; 8) added clarifying language to §§ 324.3(b)(4), 324.3(d)(7), 324.4(d) & (h), 325-1.4(b)(2) & (3); 9) clarified § 325-1.3(b)(3) that during continuing treatment a progress report must be filed for follow-up visits, which are scheduled when medically necessary but no more than 90 days apart; 10) clarified § 325-1.4(a)(9) that receipt is by the Board; 11) added missing cite to § 325-1.4(d) and changed "excepted" to "excluded"; and 12) modified § 325-1.25(c)(7) so there is no confusion that occupational & physical therapists can not request a variance.

Comments were received requesting changes to definitions, time frames, the list of pre-authorized procedures, and who resolves disputes over variances. The regulations set forth the best processes based upon the statutory authority available and, other than as described above, were not modified by the comments. In part this is due to the experience and feedback obtained through the pilot program and comments received prior to finalizing the regulations. The most significant comments received from multiple commentators are discussed below, and all of the comments received are discussed in detail in the complete Assessment of Public Comments.

Some comments expressed a need for addition time before the regulations and medical treatment guidelines (Guidelines) took effect. In response the effective date of the regulations and Guidelines has been delayed until December 1, 2010.

Three comments raised concerns about the definition of "Maximum Medical Improvement (MMI)." The commentators found the definition, among other things, to be vague, too subjective, and lacking any time parameter, presents obstacles to classification, needs to be more uniform and objective, and that more concise definitions are available from other states and one such definition (Texas) should be adopted. No changes were made to this definition. The advisory committee developing impairment guidelines developed a definition of MMI that is basically the same as the definition in this rule. The recommended definition for the impairment guidelines starts with the exact same language used in the definition in this rule and then adds additional language, but the definitions are still consistent. It is not clear how the example from Texas suggested by this entity is any more precise as it uses phrases such as "no longer reasonably be anticipated."

Three comments objected to the list of pre-authorized procedures in § 324.2(d) and one objected to the reference to this list in § 325-1.4(a)(1). The objections included the belief that the statutory language added to Workers' Compensation Law (WCL) § 13-a(5) was never intended to allow every medical procedure as preauthorized, the language of WCL § 13-a(5) is vague or confusing, the proposed rule negates the due diligence implied in the bill memo to Chapter 6 of the Laws of 2007, and this provision conflicts with WCL § 13-a(5).

This provision was not changed as the Chair and Board disagree with the statutory interpretations in the comments. WCL § 13-a(5) was amended in 2007 to authorize the issuance and maintenance of a list of pre-authorized procedures, with the approval of the Superintendent of Insurance. Under this section, the only treatment that needs to be pre-authorized is special services costing more than $1,000. Reading the whole subdivision it is clear that the authority exists for a list of pre-authorized special services costing more than $1,000. The purpose of this change is to speed access to care. The creation of a pre-authorized list allows for regulatory flexibility to add and remove procedures based upon best practice. The Guidelines set up best practices for treatment and will be updated regularly to remain current. The regulation establishes the pre-authorized list as all tests, procedures, and treatment consistent with the Guidelines, except for 12 specifically identified procedures. The term "consistent with the guidelines" is defined in the regulations. If a provider is treating consistent with the Guidelines, so he is following the best practices set by the Board, it did not make sense to have him request approval for a test or procedure costing more than $1,000.

Four comments objected to the amendment in § 325-1.3 extending the period between which reports on follow-up visits must be filed from 45 days to 90 days. The comments state that an additional six weeks of indemnity benefits will be provided during the additional 45 days, this change will prevent proper case management and meaningful application of the Guidelines, will prevent return to work, and will result in additional IMEs. Suggestions were received to retain the current 45 day time period and to reduce it to 30 days.

It was not the intent of this provision to state that physicians have 90 days after the examination of a claimant to submit a medical report. Rather, the intent was to require follow-up visits with the physician at medically necessary intervals, for which the physician would submit a medical report, except that the intervals between follow-up visits can be no more than 90 days. To ensure the provision is not misinterpreted, it has been reworded. Physicians have complained that they are forced to examine claimants when it is not medically necessary in order to file a medical report every forty-five days, which results in medical reports that are no different than the previous report, because nothing has changed medically. In addition, the provider is entitled to a fee for the office visit, which increases costs. By requiring reports only when a visit is medically necessary, but no more than ninety days apart, fewer unnecessary office visits will be scheduled and costs reduced.

Numerous comments were received about the medical treatment guidelines (Guidelines) themselves. The only changes to the Guidelines were to correct typographical errors, misspellings, and formatting, insert words that were accidentally left out, and to correct one section so it is now clinically feasible. Details on the changes to the Guidelines are set forth in the full assessment.

A number of the comments received challenged the statement that the Guidelines are evidence-based or took issue with the treatment guideline chosen as the base document. The Guidelines were developed by an advisory committee comprised of representatives from the Insurance Department, Board, and Labor Department, and highly qualified and respected medical professionals selected by labor, business, and the Insurance Department. The advisory committee was created to develop the Guidelines as directed by former Governor Spitzer in a letter dated March 13, 2007. On December 3, 2007, medical treatment guidelines for the neck, back, shoulder, and knee that all providers would be required to use when treating injuries to those body parts were sent to the Chair.

When developing the Guidelines, the advisory committee performed a thorough review of available state-developed workers' compensation treatment guidelines, the American College of Occupational and Environmental Medicine (ACOEM) guidelines, and two commercially available guidelines. Consideration was limited to guidelines used for treating work-related injuries and illnesses. For the mid and low back, the advisory committee chose Chapter 12, Low Back Disorders (Revised 2007), of the Occupational Medicine Practice Guidelines, 2nd Edition published and copyrighted by the ACOEM. For the neck, knee, and shoulder, the advisory committee chose the State of Colorado's treatment guidelines with charts from the Washington State guidelines to supplement the Knee and Shoulder guidelines. The guidelines chosen are nationally recognized medical treatment guidelines used for treating individuals with workplace injuries.

After the recommended guidelines were submitted to the Chair, various entities submitted comments and met with the Chair to discuss the guidelines. On August 13, 2009, the Chair issued a notice advising the public that comments on the Guidelines would be accepted through September 9, 2009. The notice also stated that after that date the Board's Medical Director and staff would evaluate all comments, as well as recent developments in medical treatment guidelines, and incorporate into the Guidelines those changes that are most important to patient well-being and supported by medical literature. Comments received after September 9th and comments received that were not incorporated, would be retained and considered during the regular process of review and updating of the Guidelines. The Medical Director and Board staff reviewed the comments, and on January 19, 2010, revised guidelines were released. Final guidelines were released on June 30, 2010.

Many of the comments requested changes to the Guidelines based on literature and offered evidence in support. However, as just explained a formal comment period on the Guidelines was conducted in 2009, which resulted in revisions to the Guidelines. It is recognized that medical science and practice will change over time and the Guidelines must keep pace with these changes. The Chair will implement a process to review and critique available medical literature and update the Guidelines as indicated. The comments that requested changes to the Guidelines recommendations based upon literature provided will be considered at that time. In addition, some of the requested changes were submitted and considered for the revised Guidelines released on January 19, 2010. The specific suggestions are addressed in the full assessment of public comment.

FORM LETTERS

Of the 3110 form letters, approximately 2096 were from individuals stating they were claimants receiving chiropractic treatment. These letters expressed concern about needing treatment outside the Guidelines which is addressed through the Variance process, and support for the comments and recommendations of the chiropractic profession which are fully discussed in the full assessment.

Approximately 364 of the form letters were from individuals stating they were chiropractors authorized to treat claimants. The letters expressed: 1) concern about perceived unanswered questions about the implementation and applicability of the Guidelines, which are actually addressed in the regulations; 2) that the Guidelines may limit a chiropractor's ability to perform medically necessary services for which he or she is qualified, trained and licensed to perform, but no example is provided; and 3) concern about the manner in which chiropractors must bill for services provided to claimants, which is not the subject of this regulation. Finally, the letters express support for the comments of the New York State Chiropractic Association.

Approximately 548 form letters were submitted by patients receiving physical therapy services. The letters express two main concerns, reimbursement and access. The first concern regarding reimbursement is not the subject of this rule. The second concern relates to the maximum number of visits or modalities and the concern it will limit potentially needed care, which is addressed through the variance process.

Approximately 102 of the form letters were submitted by physical therapists and discussed three main concerns: 1) omission of the physical therapy professions current evidence based practice patterns; 2) reimbursement for physical therapy services and the RVU cap, which is not part of this regulation; and 3) the limits on visits or modalities set forth in the Guidelines. As stated above, the guidelines chosen were picked because they were the best of the guidelines available for work related injuries. As mentioned above, if additional visits or modalities are necessary then a variance can be requested by the treating physician ordering such additional visits or modalities.