TITLE 28.INSURANCE

Part 1. TEXAS DEPARTMENT OF INSURANCE

Chapter 7. CORPORATE AND FINANCIAL REGULATION

Subchapter A. EXAMINATION AND FINANCIAL ANALYSIS

28 TAC §7.18

The Commissioner of Insurance adopts amendments to §7.18, concerning the adoption by reference of the National Association of Insurance Commissioners Accounting Practices and Procedures Manual (Manual). The amended section is adopted with changes to the proposed text as published in the December 24, 2004, issue of the Texas Register (29 TexReg 11896).

The amendments are necessary to update the version of the Manual previously adopted by the department. The section adopts the Manual by reference with deference to Texas statutes, regulations, and to exceptions enumerated in the section. The amendments to §7.18, concerning Statements of Statutory Accounting Principles (SSAP) provide guidance to independent accountants, industry accountants, and the department's analysts and examiners as how to properly record business transactions for the purpose of accurate statutory reporting. SSAP provides a nationwide standard method of accounting, which most insurers, including health maintenance organizations, are required to use for statutory financial reporting guidance. Although SSAP creates a more consistent regulatory environment, they do not preempt individual state legislative or regulatory authority. The Manual is a comprehensive guide to statutory accounting principles and includes the SSAP that have been adopted by the National Association of Insurance Commissioners (NAIC). Editorial clarifications were made throughout the section to avoid potential confusion. These clarifications did not result in any substantive change to the meaning or effect of the section.

The adopted section provides for more consistent and efficient regulation of insurance. The adoption of the March 2004 version of the Manual provides for a more consistent regulatory environment and provides a single source for accounting guidance. The amendments adopt by reference the March 2004 version of the Manual with the exceptions noted in subsections (c) and (d). The amendments include new SSAP Nos. 88, 89, 91, and subsection (e). SSAP No. 88 supersedes SSAP No. 46, paragraphs 2 and 3 of SSAP No. 32, and paragraphs 4 - 6 of SSAP No. 68. SSAP No. 88 is a new SSAP on the valuation of subsidiary, controlled, and affiliated entities. SSAP No. 89 supersedes SSAP No. 8 and provides statutory accounting guidance for accounting for employers' pensions. SSAP No. 91 supersedes SSAP Nos. 18, 33, and 45 and provides for accounting for transfers and servicing of financial assets including securitizations and various repurchase agreements. New subsection (e) provides for an insurer to request a permitted accounting practice from the department at least 30 days before filing a financial statement that reflects the deviated accounting practice.

No comments were received.

The amendments are adopted under the Texas Insurance Code Articles 1.15, 1.32, 3.33, 5.61, 21.28-A, 21.39 and §§32.041, 36.001, 802.001, 823.012, 841.004, 843.151, 861.255, 862.001. Article 1.15 mandates that the department examine the financial condition of each carrier organized under the laws of Texas or authorized to transact the business of insurance in Texas and adopt by rule procedures for the filing and adoption of examination reports. Article 1.32 authorizes the Commissioner to establish standards for evaluating the financial condition of an insurer. Article 3.33 provides standards for the development and administration of plans for the investment of the assets of insurers. Article 5.61 provides that reserves for workers' compensation insurers transacting business in this state shall be computed in accordance with rules adopted by the Commissioner for the purpose of adequately protecting insureds, securing the solvency of the insurer, and preventing unreasonably large reserves. Article 21.28-A authorizes the Commissioner to adopt rules necessary to remedy the financial condition and the management of certain insurers. Article 21.39 authorizes the Commissioner to adopt rules for establishing reserves applicable to each line of insurance recommended by the NAIC. Section 32.041 and §802.001 authorize the Commissioner to provide required financial statement forms. Section 823.012 authorizes the Commissioner to issue rules and orders necessary to implement the provisions of Chapter 823 (Insurance Holding Company Systems). Section 843.151 authorizes the Commissioner to promulgate rules as are necessary to carry out the provisions of Chapter 843. Sections 841.004, 861.255 and 862.001 authorize the Commissioner to adopt rules defining electronic machines and systems, office equipment, furniture, machines and labor saving devices, and the maximum period for which each such class may be amortized. Section 36.001 provides that the Commissioner may adopt any rules necessary and appropriate to implement the powers and duties of the department under the Insurance Code and other laws of this state.

§7.18.National Association of Insurance Commissioners Accounting Practices and Procedures Manual.

(a) The purpose of this section is to adopt statutory accounting principles, which will provide independent accountants, industry accountants, and the department's analysts and examiners guidance as how to properly record business transactions for the purpose of accurate statutory reporting. The March 2004 version of the Accounting Practices and Procedures Manual (Manual) published by the National Association of Insurance Commissioners (NAIC) will be utilized as the guideline for statutory accounting principles in Texas to the extent the Manual does not conflict with provisions of the Insurance Code or rules of the department. The Commissioner reserves all authority and discretion to resolve any accounting issues in Texas. When making a determination on the proper accounting treatment for an insurance or health plan transaction, the Commissioner shall refer to the sources in paragraphs (1) - (6) of this subsection in the respective order of priority listed. Furthermore, §§3.1501 - 3.1505, 3.1605, 3.1606, 3.7004, 7.7, 7.85 and 11.803 of this title (relating to Annuity Mortality Tables, General Requirements, Required Opinions, Contract Reserves, Subordinated Indebtedness, Audited Financial Reports and Investments, Loans and Other Assets), preempt any contrary provisions in the Manual:

(1) Texas statutes;

(2) department rules;

(3) directives, instructions, and orders of the Commissioner;

(4) the Manual;

(5) other NAIC handbooks, manuals, and instructions, adopted by the department; and

(6) Generally Accepted Accounting Practices.

(b) The Commissioner adopts by reference the March 2004 version of the Manual, with the exceptions and additions set forth in subsections (c) and (d) of this section, as the source of accounting principles for the department when examining financial reports and for conducting statutory examinations and rehabilitations of insurers and health maintenance organizations licensed in Texas, except where otherwise provided by law. This adoption by reference shall be applied to examinations conducted as of January 1, 2005 and thereafter, and also shall be used to prepare all financial statements filed with the department for periods after January 1, 2005.

(c) The Commissioner adopts the following exceptions and additions to the Manual:

(1) In addition to the statements of statutory accounting principles in the Manual, Statement of Statutory Accounting Principles (SSAP) No. 88 regarding valuation of subsidiary, controlled, and affiliated entities and SSAP No. 91 regarding accounting for transfers and servicing of financial assets including securitizations and various repurchase agreements adopted by the NAIC on September 12, 2004 and effective January 1, 2005, are adopted by reference and shall be used to prepare all financial statements filed with the department for periods after January 1, 2005. This adoption of SSAP Nos. 88 and 91 effectively replaces SSAP Nos. 18, 33, 45, 46, paragraphs 2 and 3 of SSAP No. 32, and paragraphs 4 - 6 of SSAP No. 68.

(2) Retrospective premiums must be billed within 60 days of computation and audit premiums must be billed within 60 days of the completion of the audit in determining the beginning date from which the 90 day period is calculated to determine admissibility of uncollected premium balances under SSAP No. 6.

(3) Electronic machines, constituting a data processing system or systems and operating systems software used in connection with the business of an insurance company acquired after December 31, 2000, may be an admitted asset as permitted by Insurance Code §§841.004, 861.255, 862.001, and any other applicable law and shall be amortized as provided by the Manual. All such property acquired prior to January 1, 2001, may be an admitted asset as permitted by Insurance Code §§841.004, 861.255, 862.001, and any other applicable law, and shall be amortized in full over a period not to exceed ten years.

(4) Furniture, labor-saving devices, machines, and all other office equipment may be admitted as an asset as permitted by Insurance Code §§841.004, 861.255, 862.001, and any other applicable law and, for such property acquired after December 31, 2000, depreciated in full over a period not to exceed five years. All such property acquired prior to January 1, 2001, may be an admitted asset as permitted by Insurance Code §§841.004, 861.255, 862.001, and any other applicable law, and shall be depreciated in full over a period not to exceed ten years.

(5) Goodwill, as reported on a regulated entity's statutory financial statements as of December 31, 2000, and any additional goodwill acquired thereafter, beginning January 1, 2001, shall be admitted as an asset and accounted for as permitted by SSAP Nos. 61 and 68. All other amounts of goodwill, including, but not limited to, such amounts that may have been previously expensed, shall not be allowed as an admitted asset. However, notwithstanding the provisions of SSAP Nos. 61 and 68, all methods of non-insurer subsidiary and affiliate valuation permitted by Insurance Code §§823.301 - 823.307 may be used for the purposes of goodwill calculation.

(6) All certificates of deposit, of any maturity, may be classified as cash and are subject to the accounting treatment contained in SSAP No. 2, notwithstanding the provisions of SSAP No. 26.

(d) A farm mutual insurance company, statewide mutual assessment company, local mutual aid association, or mutual burial association that has less than $5 million in annual direct written premiums need not comply with the Manual.

(e) In the event a domestic insurer desires to deviate from the accounting guidance in a Texas statute or any applicable regulation, the insurer shall file a written request for a permitted accounting practice. Such filing shall be made with the Associate Chief Examiner, Texas Department of Insurance, Mail Code 305-2E, P.O. Box 149104, Austin, Texas 78714-9104 at least 30 days before filing the financial statement affected by the deviated accounting practice. Insurers shall not use deviated accounting practice without the department's prior approval.

(f) This section shall not be construed to either broaden or restrict the authority provided under the Insurance Code to insurers, including health maintenance organizations.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 15, 2005.

TRD-200500695

Brenda Caldwell

Special Regulatory Counsel

Texas Department of Insurance

Effective date: March 7, 2005

Proposal publication date: December 24, 2004

For further information, please call: (512) 463-6327


Part 2. TEXAS WORKERS' COMPENSATION COMMISSION

Chapter 108. FEES

28 TAC §108.1

The Texas Workers' Compensation Commission (the Commission) adopts amendments to §108.1 (concerning Charges for Copies of Public Information) without changes to the proposed text published in the November 5, 2004, issue of the Texas Register (29 TexReg 10216).

As required by the Government Code §2001.033(1), the Commission's reasoned justification for this rule is set out in this order, which includes the preamble, which in turn includes the rule. This preamble contains a summary of the factual basis for the rule.

No comments were received in writing or at a public hearing.

The amendments are adopted to replace references to the General Services Commission with references to the Texas Building and Procurement Commission.

The General Services Commission was abolished and its functions were transferred in part to the Texas Building and Procurement Commission, newly created by the 77th Texas Legislature in Senate Bill 311. The amendments delete from §108.1 all references to the General Services Commission and replace them with "Texas Building and Procurement Commission" to reflect the correct agency with the responsibility of establishing charges for providing copies of public information or making public information available for inspection.

The rule amendments are adopted pursuant to the Texas Labor Code, §401.021, which sets out the application of other acts, including The Texas Public Information Act, to records of the Commission; Texas Labor Code, §402.61, which authorizes the Commission to adopt rules necessary for the implementation and enforcement of the Texas Workers' Compensation Act; Texas Labor Code, §402.64, which authorizes the Commission to set reasonable fees for services provided to persons requesting services from the Commission; Texas Labor Code, §402.81(d), which authorizes the Commission to charge a reasonable fee for other confidential information when access to confidential commission records is requested; Texas Labor Code, §402.083, which provides for confidentiality of claim file information; Texas Labor Code, §402.084, which provides for the release of a record check on an employee; Texas Labor Code, §402.086, which provides for the transfer of confidentiality of information released to persons by the Commission; Texas Labor Code, §402.087, which allows a prospective employer to obtain information on the prior injuries of an applicant for employment under certain circumstances; Texas Labor Code, §402.088, which sets out the information available under §402.087; Texas Labor Code, §402.092, which provides for the confidentiality of information in commission investigation files; Texas Labor Code, §411.048, which requires the Commission to charge employers for the reasonable cost of services provided by the Health and Safety division; Texas Labor Code, §413.018, which provides for the periodic review of medical care in claims where return to work time frames are exceeded; Texas Labor Code, §413.020, which authorizes the Commission to charge for access to, evaluation of, and review of health care treatment, fees or charges; Texas Labor Code, §414.004, which authorizes the Commission to review the records of insurance carriers and to charge for the reasonable expenses of such review; and Texas Government Code §552.262, which requires the Commission to use the rules adopted by the General Services Commission to determine charges for providing copies of public information or making public information available for public inspection.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 18, 2005.

TRD-200500762

Susan Cory

General Counsel

Texas Workers' Compensation Commission

Effective date: March 10, 2005

Proposal publication date: November 5, 2004

For further information, please call: (512) 804-4287


Chapter 134. BENEFITS--GUIDELINES FOR MEDICAL SERVICES, CHARGES, AND PAYMENTS

Subchapter E. HEALTH FACILITY FEES

28 TAC §134.402

The Texas Workers' Compensation Commission (the commission) adopts amendments to §134.402, concerning the Ambulatory Surgical Center Fee Guideline with changes to the proposed text published in the December 3, 2004, issue of the Texas Register (29 TexReg 11257). The Ambulatory Surgical Center Fee Guideline is one of several rules that will comprise Subchapter E, regarding Health Facility Fees.

As required by the Government Code §2001.033(1), the commission's reasoned justification for this rule is set out in this order, which includes the preamble, which in turn includes the rule. This preamble contains a summary of the factual basis of the rule, a summary of comments received from interested parties, names of those groups and associations who commented and whether they were in support or opposition to adoption of the rule, and the reasons why the commission disagrees with some of the comments and recommendations.

Changes made to the proposed rule are in response to public comment received in writing and at a public hearing held on January 6, 2005, and are described in the summary of comments and responses section of this preamble.

The commission proposed the amendments to address information received by the commission subsequent to the April 15, 2004 adoption of this rule concerning certain impacts of the new rule guideline on participants in the Texas workers' compensation system.

The Texas Workers' Compensation Act (Act) requires that guidelines for medical services fees be fair and reasonable and designed to ensure the quality of medical care and to achieve effective medical cost control. The guidelines may not provide for payment of a fee in excess of the fee charged for similar treatment of an injured individual of an equivalent standard of living and paid by that individual or by someone acting on that individual's behalf. The commission must consider the increased security of payment afforded by the Act in establishing the fee guidelines (see Texas Labor Code §413.011(d)).

More recent statutory requirements added to §413.011(a) of the Texas Labor Code also require that the commission use health care reimbursement policies and guidelines that reflect the standardized reimbursement structures found in other health care delivery systems with minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements. The statute additionally requires the commission to adopt the most current reimbursement methodologies, models, and values or weights used by the federal Health Care Financing Administration (HCFA), (now called the Centers for Medicare and Medicaid Services (CMS)), to achieve standardization, including applicable payment policies relating to coding, billing, and reporting, and may modify documentation requirements as necessary to meet the requirements of §413.053 of the Act (relating to Standards of Reporting and Billing).

Under Texas Labor Code §413.011(b), the commission is required to develop conversion factors or other payment adjustment factors (PAFs) in determining appropriate fees when writing these guidelines, taking into account economic indicators in health care by not adopting conversion factors or other PAFs based solely on those factors as developed by the CMS. The subsection further states that it does not directly itself adopt the Medicare fee schedule into Texas law.

This rule applies to facility services provided by an ambulatory surgical center (ASC), other than professional medical services. An "ambulatory surgical center" means such a center that is properly licensed by the Texas Department of Health under the Texas Ambulatory Surgical Center Licensing Act, which was first enacted in 1985 by the 69th Texas Legislative Session. Further information can be obtained at http://www.tdh.state.tx.us/hfc/asc.htm. ASCs located outside the state of Texas should be licensed by that jurisdiction's licensing body, if such licensing exists, when providing services to Texas injured workers under the Act.

At the request of, and based on some preliminary information provided by some system participants, the commission re-examined two specific areas within §134.402, regarding the Ambulatory Surgical Center Fee Guideline, for potential amendment. The two specific areas explored were: (1) amending the ASC List of Medicare Approved Procedures (Medicare's List) for the inclusion/exclusion of procedures with appropriate ASC group payment; and (2) exploring reimbursement options for implantable devices.

The commission requested information on procedures not on Medicare's List by procedure code to include number of cases, charged and paid amounts by commercial insurance groups, Medicare, Medicaid and worker's compensation in all settings (i.e., physician office, ASC, hospital outpatient and inpatient) for 2003. The commission also requested specific information for implantable devices by procedure code to include number of cases, charged and paid amounts by commercial insurance groups, Medicare, Medicaid and workers' compensation in all settings, and a description of the reimbursement methodologies used for 2003.

The commission received a limited amount of information in response to this request. The information provided showed that changes in technology and other developments in the health care industry have resulted in some procedures safely being provided to injured workers in ASCs and that continuing to allow some of these procedures to be provided in ASCs is safe and appropriate, and could in some instances, be cost-effective. These amendments proposed for adoption are based on this information, discussions held with, and information from, ASC Focus Group members, public comment and research and analysis by the commission staff, including the commission's Medical Advisor. The amendments also address concerns raised by system participants and members of the ASC Focus Group regarding whether the current case rate reimbursement adequately reimburses for devices integral to the surgery.

To help in understanding the full picture, the commission has addressed the background and basis for the rule, and requirements of the current rule, including those parts and issues that are not the subject of this rulemaking.

This rule was initially adopted in April 2004 to comply with numerous and complex statutory mandates in Texas Labor Code §413.011. House Bill 2600 (HB-2600), adopted during the 2001 Texas Legislative Session, amended §413.011 of the Act to add new requirements for commission reimbursement policies and guidelines. The statute requires the commission to balance the rigorous, and often competing, statutory requirements in setting reimbursement levels and guidelines for medical services. The commission's mandate is to:

* Establish fees that are fair and reasonable and sufficiently high to ensure the quality of medical care and sufficiently low to achieve effective medical cost control;

* Establish fees that do not exceed those paid by or on behalf of individuals with an equivalent standard of living to that of injured employees;

* Consider the increased security of payment afforded by the Act in establishing the fee guidelines;

* Use health care reimbursement policies and guidelines that reflect the standardized reimbursement structures found in other health care delivery systems with minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements;

* Adopt the most current reimbursement methodologies, models, and values or weights used by the federal HCFA to achieve standardization, including applicable payment policies relating to coding, billing, and reporting;

* Modify documentation requirements as necessary to meet the requirements of §413.053 of the Act (relating to Standards of Reporting and Billing); and

* Develop conversion factors or other PAFs in determining appropriate fees, taking into account economic indicators in health care.

Prior to adoption of §134.402, the Texas workers' compensation system did not have a fee schedule for healthcare provided in outpatient settings, which includes ASCs. Therefore, those services were reimbursed on a case-by-case determination of what is fair and reasonable under section §134.1 of this title (relating to Use of the Fee Guidelines). Reimbursements for all reasonable and medically necessary medical and/or surgical inpatient services are currently covered by §134.401 of this title (relating to Acute Care Inpatient Hospital Fee Guideline). Professional medical services are covered in §134.202 of this title (relating to Medical Fee Guideline) and Chapter 134, Subchapter F (relating to Pharmaceutical Benefits) of the commission rules.

Section 413.011 of the Act states that it does not adopt the Medicare fee schedule; it states, further, that the commission shall not adopt conversion factors or other PAFs based solely on those factors as developed by CMS. Consistent with these statutory directives, the reimbursement levels and fee guideline established by the original rule use the Medicare reimbursement structure as a baseline, or reference point, for the maximum allowable reimbursement (MAR) calculations for services provided in an ASC health care facility. However, the commission did not adopt the Medicare fee schedule nor were MARs based solely on the Medicare reimbursements. The commission's adoption of the ASC PAF was based upon due consideration of all of the statutory requirements for fee guidelines. These statutory criteria, found in §413.011, are different from the Medical Economic Index (MEI), the Sustainable Growth Rate (SGR) factors and other indices that Medicare is required by federal law to consider in establishing its reimbursement rates. The MEI is a weighted average of price changes for goods and services used to deliver physician services. The goods and services include physician time and effort as well as practice expenses. (MedPAC Report to Congress, Medicare Payment Policy, March 2002, p.77). The adjustments made each year reflect the previous year's changes in the prices of the needed goods and services. In general, reimbursement rates would increase in relation to changes in the prices of such goods and services as measured by the MEI. The SGR formula serves as a restraint on price increases driven by inflation in that it ties overall expenditures to a target based on the real level of growth in the gross domestic product. Additionally, Medicare considers the Consumer Price Index - Urban (CPI-U) in ambulatory surgery reimbursement rate updates. Thus, Medicare considers economic factors in establishing reimbursement rates. Although these factors have been considered in setting Medicare's reimbursement rates, the Medicare Modernization Act impacted these adjustments. As a result, Medicare ASC group rates have been rolled back and frozen at the 2002 rates.

In establishing a reimbursement methodology for services provided by ASC facilities, the current rule uses the required Medicare methodology for determining reimbursement in the Texas workers' compensation system, providing standardization of reimbursement structures by aligning the workers' compensation reimbursement methods and billing procedures with those used by CMS. As an exception and minimal modification to this standardization, the rule specifically did not adopt Medicare retroactive payment policy changes for services already provided within the Texas workers' compensation system.

The challenge in this rule amendment has been for the commission to establish reimbursement rates, including the PAF, which take the diverse Texas statutory factors into account and provide an appropriate fee guideline for the Texas workers' compensation system. The statutory criteria of §413.011 establish a range within which the commission is directed to exercise administrative discretion to select conversion factors. The statutory requirement ensures quality of medical care and requires that fees not be set so low as to deprive covered workers of access to qualified providers. While the statutory criterion does not require that fees be set high enough to induce all physicians to participate, or to prevent every single individual physician from deciding to stop participating, it does require consideration of potential impacts on participation by providers generally. The statutory requirement that workers' compensation not pay more than payers pay on behalf of patients from populations with equivalent standards of living address a cap on workers' compensation fees, except and to the extent that special features of workers' compensation require higher fees. It therefore permits consideration of any special features of workers' compensation and what additional payment, if any, they warrant. The statutory requirement to take account of the increased security of workers' compensation payment permits consideration of what offsetting reductions in payments, compared with other payer systems that do not pay 100%, is warranted. Within these limits, the commission must consider how payments may be set to control medical costs without compromising access to quality medical care to injured workers. The commission adopted the Medicare reimbursement methodology and adopted an appropriate PAF that meets the statutory requirements, taking into account all pertinent information and having given full consideration to public comment received at the time.

"The underlying question in most state public policy debates about fee schedules is 'What is the optimal fee level?'" Studies at the time of the rule's adoption, and to date, in either workers' compensation or Medicare have yet to determine the optimal fee level. A review of the literature revealed, "Conceptually, most would agree that the optimal fee level is one that provides access to quality care in the most cost-efficient manner. According to the economic model, it is the price that would induce health care providers to supply services that characterize 'good quality care' - not too much, not too little, and only those services that produce positive outcomes whose benefits are more valuable than the costs paid for the services. The optimal fee level, then, is one that minimizes incentives to over-treat or treat with more costly services, even though less expensive, equally effective services exist. If, for example, complex surgeries provide relatively high profit margins (and therefore greater financial incentives), the optimal balance between cost and quality would not be achieved. On the other hand, if reimbursements do not provide a fair and competitive rate of return to providers, access to particular services would be hampered by financial disincentives, thereby jeopardizing access to care." (WCRI August 2002, p. 5)

The statutory requirements mirror the factors, concerns, and objectives (access, quality, outcomes, utilization, cost) mentioned above. The commission considered each in its initial adoption of the rule and in this adoption of amendments to the rule.

In developing this rule, and in this subsequent amendment, the commission carefully and fully analyzed all of the statutory and policy mandates and objectives and all the facts and evidence gathered and submitted, as well as all comments received. The commission utilized all of this, and its expertise and experience, including recommendations from the commission's Medical Advisor to amend this rule which balances the statutory mandates, including those to ensure that injured workers receive the quality health care reasonably required by the nature of their injury as and when needed and to ensure that fee guidelines are fair and reasonable, with the statutory mandate to achieve effective medical cost control. Full and objective analysis and consideration were given to all of the relevant comments received pertaining to the proposed amendments, as evidenced by the revisions made from the rule as proposed and the commission's responses to comments in this preamble.

Several research reports have shown that Texas workers' compensation medical costs continue to exceed those in other states and other health care delivery systems.

* Policy year 1995 data show that the average medical cost per claim in Texas exceeds the national average by almost 80% ($4,912 in Texas compared to $2,735 nationwide). (Texas Research and Oversight Council (ROC) on Workers' Compensation and Med-FX, LLC., Striking the Balance: An Analysis of the Cost and Quality of Medical Care in the Texas Workers' Compensation System, A Report to the 77th Texas Legislature, January 2001, citing National Council on Compensation Insurance (NCCI), Annual Statistical Bulletin, 1999)

* The average medical payment (paid and incurred) per claim with more than seven days' lost-time in Texas was the highest of the eight states analyzed (California, Connecticut, Florida, Georgia, Massachusetts, Minnesota, Pennsylvania, and Texas). Together these states account for at least 40% of the nation's workers' compensation benefits. (WCRI, Benchmarking the Performance of Workers' Compensation Systems: CompScope Multistate Comparisons, July 2000)

* In claims from 1996, the average medical payment per claim in Texas was $6,495, which is 35% higher than the states' average. (WCRI, July 2000)

* The average of medical payments in Texas per claim with seven or more days lost time was the highest of the states in the analysis (33% higher than the states' average and 36% higher than the states' median). (WCRI, The Anatomy of Workers' Compensation Medical Costs and Utilization: A Reference Book, December 2000)

* The average of medical payments in Texas for all claims was 47% higher than the states' average and 53% higher than the states' median. (WCRI, December 2000)

* Of nine states analyzed (California, Colorado, Florida, Georgia, Kentucky, Minnesota, New Jersey, Oregon, and Texas), Texas has the highest average medical costs per claim (more than 20% higher than the second-highest state, New Jersey, and more than 2.5 times higher than the lowest-cost state, Kentucky). (ROC, January 2001)

* When similar types of injuries were compared in the group health and workers' compensation systems, Texas had higher than average medical costs for the top five types of injuries. (ROC, January 2001)

* When compared with group health (a State of Texas employee Preferred Provider Organization (PPO) group health plan), average workers' compensation medical costs for State of Texas injured employees were approximately six times higher per worker ($578 per worker in this group health system compared to $3,463 per worker in the Texas workers' compensation system, 18 months post-injury). (ROC, January 2001)

* Texas continues to have the highest average medical payment per claim among the study states - 78 percent higher than the 12-state median for all claims and 39 percent higher than the 12-state median for claims with more than seven days of lost time for 1999/2000. (WCRI, The Anatomy of Workers' Compensation Medical Costs and Utilization: Trends and Interstate Comparisons, 1996-2000, July 2003)

* Texas continues to have the highest average medical payment per claim among the study states - 29 percent higher than the 12-state average for claims with more than seven days of lost time for 1999/2000. (WCRI, The Anatomy of Workers' Compensation Medical Costs and Utilization: Trends and Interstate Comparisons, 1996-2000, July 2003)

* Texas continues to have the highest average medical payment per claim among the study states - 57.2 percent higher than the 12-state average for all claims for 1999/2000. (WCRI, The Anatomy of Workers' Compensation Medical Costs and Utilization: Trends and Interstate Comparisons, 1996-2000, July 2003)

* The average medical payment paid per claim for 2001 claims with more than seven days' lost-time in Texas was the highest of the twelve states analyzed (California, Connecticut, Florida, Illinois, Indiana, Louisiana, Massachusetts, North Carolina, Pennsylvania, Tennessee, Wisconsin and Texas). Medical payments per claim have been growing at double digit-rates since 1998/1999. (WCRI, Compscope Benchmarks: Multistate Comparisons, 4th Edition, February 2004)

* In claims from 2001, the average medical payment paid per claim in Texas was $9,314, which is 38.3% higher than the median for the 12 states mentioned above. (WCRI, February 2004)

* Medical costs and the quantity of medical care in Texas were among the highest of the four states studied. Despite that, outcomes achieved by Texas workers, who received more medical care, were much lower than the outcomes achieved by workers in Massachusetts and Pennsylvania where average medical costs per claim were 58% and 31% lower respectively than in Texas. (WCRI, Outcomes for Injured Workers in California, Massachusetts, Pennsylvania and Texas, December 2003)

The Medicare reimbursement system has primarily progressed from a retrospective fee for service reimbursement system to a prospective payment system (PPS). Under the Medicare PPS, facilities receive a fixed amount for treating patients in certain diagnostic and/or procedural categories. Reimbursement is based on specific diagnostic and/or procedural groupings, resource utilization, national and regional averages, and costs specific to the facility. The Medicare ASC reimbursement methodology prospectively establishes a set payment amount for each type of facility service that CMS has determined may be reimbursed in an ASC setting; each of these services falls into one of nine specific categories, or ASC groups.

Currently for ASC services (which are primarily surgeries and items incident to surgery), Medicare reimburses using the ASC case rate methodology. Payment is determined based on the surgeries performed, the associated grouping(s), payment rates for each surgery, and the geographic wage index of the facility. This rule amendment applies this Medicare ASC grouping reimbursement methodology for ASC facility services within the Texas workers' compensation system, and allows a few surgical procedures in the Texas workers' compensation system to be performed in an ASC setting, even though not allowed in the Medicare system.

Medicare reimburses ASCs for the facility fee when a covered surgical procedure is billed. The coverable surgical procedures are approved by CMS. In general, items that are bundled or integral to the service performed are included in the facility fees and are not reimbursed separately. A single payment is made to an ASC that encompasses all "facility services" furnished by the ASC, as published by CMS in its Medicare Carriers' Manual. However, additional reimbursement is made for a number of items and services covered under other Medicare fee schedules. Examples of such "non-facility" items and services include physician services and certain durable medical equipment items. Further, Medicare sets both ASC locality specific (specific to a facility's geographic location, in accordance with Medicare payment policy) and other Part B fee schedule reimbursement amounts, such as the physician's fee schedule.

Medicare requires the use of the uniform Healthcare Common Procedure Coding System (HCPCS) for reporting professional services, procedures and supplies including those, which are separately reimbursable. Most services, procedures and supplies have a corresponding HCPCS code, that are specific and available for ASC facilities to use to bill the items for separately reimbursable items. There may be a few miscellaneous HCPCS codes available for ASC facilities to use to bill the items that do not have a code specifically describing the item, and Medicare allows reimbursement of 100% of the cost with an invoice submitted upon bill submission. Separately reimbursed surgically implanted devices previously addressed through the commission's 2002 MFG are now reimbursed separately in accordance with this rule amendment.

The term "benchmarking" as used with respect to fees in the health care industry is often misunderstood. As commonly used in the industry, and in this preamble, a benchmark is nothing more than a relevant point of reference. Saying that something is a benchmark does not mean that it is the standard or goal which one should strive to achieve. Nor does it mean that it, in and of itself, establishes the presumptive starting point, without evaluation of relevant similarities and differences.

There has been considerable discussion in the previous ASC rulemaking effort, as well as this rule amendment, related to whether use of Medicare fees as a benchmark in workers' compensation is appropriate. The commission determined that it is, for several reasons. Because of HB-2600's extensive emphasis on the Medicare system, it is appropriate to benchmark to the Medicare reimbursement system. HB-2600 requires the commission to adopt the most current reimbursement methodologies, models, and values or weights used by the federal CMS to achieve standardization, including applicable payment policies relating to coding, billing, and reporting; the commission may modify documentation requirements as necessary to meet the requirements of §413.053 of the Act (relating to Standards of Reporting and Billing). The statute also states that this section of the law does not adopt the Medicare fee schedule, and that the commission shall not adopt conversion factors or other payment adjustment factors based solely on those factors as developed by the federal CMS. Use of Medicare as a benchmark, or point of reference, does not violate these statutory provisions. As required by the statute, the commission has considered economic indicators in health care and the requirements of §413.011(d). The commission has also considered and adopted minimal modifications to the Medicare reimbursement methodology, both in the current rule and in these adopted rule amendments.

Although the Medicare system was established primarily to serve the needs of the elderly population, the program is a main component of the national health care system and has become a standard and benchmark for development and operation for many commercial and governmental health care programs. Medicare's payment policies largely define "main stream medicine." Furthermore, as noted by WCRI, workers' compensation policymakers have been showing increased interest in Medicare as a benchmark. (WCRI: Benchmarks for Designing Workers' Compensation Medical Fee Schedules, 1995-96, May 1996)

Complete information concerning all Medicare reimbursement methodologies for facilities can be found at the CMS website (www.cms.hhs.gov), Code of Federal Regulations, and the Federal Register.

Some Texas workers' compensation system participants continue to question, misinterpret, or misrepresent the data, reports and recommendations provided by Ingenix, Inc. (Ingenix) which were the basis for the PAF adopted by the commission in the original rule. Although the Ingenix report did not address the issues presented by this rule amendment, proposal and adoption, the Ingenix report and recommendations are discussed here to assist in understanding the full picture. As previously described upon initial adoption of this rule, the commission entered into a professional services agreement in June 2001, with Ingenix. Ingenix is a professional firm specializing in actuarial and health care information services, and assisted the commission in developing this and other new fee guidelines, which address fees for health care services provided in inpatient and outpatient facilities. Ingenix reviewed Medicare payment policies and reimbursement methodologies in reference to the Texas workers' compensation system to make recommendations to the commission for achieving standardization and adoption of the most current reimbursement methodologies, models, and values or weights used by the CMS, including applicable payment policies relating to coding, billing, and reporting, as mandated by Texas Labor Code §413.011. Ingenix also considered the additional statutory mandates of §413.011, which are described in earlier sections of this preamble.

Again, as detailed previously in the April 2004 adoption preamble, Ingenix analyzed hospital inpatient and outpatient, and ASC services separately. In general, the following steps were performed for each service type. The specific process used, as well as the methodology, data, and data sources is detailed in the Ingenix Final Report, which has been and remains available for review from the commission.

Ingenix considered certain economic indicators in health care, which it took into account in developing its recommendations concerning conversion factors or PAFs to be adopted by the commission. Ingenix recognized that the Medicare system reviews cost inputs in the overall health care industry, including ASCs, and updates ASC reimbursement on an annual basis. Further, in defining the market, Ingenix utilized commercial payer information that is reflective of the current reimbursement for the various payer types such as health maintenance organizations, preferred provider organizations, point of service plans, and traditional fee for service health plans (indemnity). Commercial reimbursement reflects, for the most part, negotiated rates based on both carriers' and providers' business plans. The combined Medicare market data and commercial market data reflects the actual reimbursement for services provided in the health care market; Ingenix considered all of these economic indicators of health care in its analysis and resulting recommendations.

To ensure that its recommended PAFs would not result in fees that exceed those paid by or on behalf of individuals with an equivalent standard of living to that of injured employees, Ingenix interpreted the statutory term, "equivalent standard of living," as including families with working or self-employed individuals and families that include Medicare enrollees. Medicaid enrollees were excluded since eligibility for Medicaid coverage generally occurs because of a significantly lower economic circumstance. This interpretation is supported by "A Standard of Living Comparison Between the Working Population, the Medicare Population, and the Managed Care Population," published in March of 1997 (addendum to report April 2001) and previously considered by the commission in establishing reimbursement levels. The commission has recognized that Medicare recipients have a similar standard of living as the general working population. In the study prepared by Research and Planning Consultants, the standard of living of the population covered by the Medicare program was found to exceed that of the population covered by the Act. The study further found that the standard of living of the population covered by managed care plans was at least as high as the population covered by the Act. Consequently, Medicare reimbursement is an appropriate standard for comparison to workers' compensation reimbursement.

Although Medicare is an appropriate benchmark, the commission also used other benchmarks. As required by the statute, the commission developed conversion factors or other PAFs in determining appropriate fees, taking into account economic indicators in health care. This includes the commercial private payer market and the median of that market. As stated by WCRI, it would be difficult to justify a fee schedule as a major cost containment tool if it exceeded what providers elect to receive, on average, in the free market. (WCRI: Benchmarks for Designing Workers' Compensation Medical Fee Schedules, 1995-1996, May 1996)

Reimbursement rates used in the market to pay providers include an additional amount to account for the fact that providers are not always reimbursed fully for all services. Ingenix stated, that because of the workers' compensation benefit structure and the financial stability of workers' compensation payers, providers are expected to receive payment of the proper reimbursement amounts for their goods and services that are medically necessary for the treatment of injured employees and this security of payment alleviates the need to increase reimbursement rates for possibilities of non-payment in the market.

Recognizing the statutory mandate that the commission establish guidelines that provide the assurance of quality medical care together with achieving effective medical cost control, Ingenix observed that "reimbursement levels must therefore must be sufficiently high to ensure access to quality care, sufficiently low to achieve medical cost control, and not in excess of fees paid by or on behalf of individuals with an equivalent standard of living." Ingenix's recommended range for ASC reimbursement within the Texas workers' compensation system successfully achieved these goals.

In developing the recommended range, Ingenix used the following process:

* Estimate the number of covered lives and utilization for Medicare and for each type of commercial insurance contract;

* Determine historical Texas payment levels for Medicare and for commercial insurance by type of contract;

* Adjust the Medicare and commercial contract history to a workers' compensation mix of services;

* Trend forward the historical payment levels;

* Project the 2004 payment level currently in place for commission payers; and

* Establish a recommended range for reimbursement as a percent of Medicare.

Additionally, Ingenix reviewed and analyzed the current market using Medicare, commercial, and commission historical medical claims reimbursement information. Ingenix also reviewed other states' workers' compensation facility reimbursement in comparison to Medicare reimbursement, but was unable to develop comparisons because each state approached its reimbursement methodology differently. Taking into account relevant health care economic indicators, Ingenix made recommendations concerning Medicare reimbursement methodologies and PAFs to be used in determining appropriate reimbursement and estimated system impact. Ingenix further provided recommendations regarding minimal modifications to Medicare reimbursement methodologies and payment policies necessary to meet occupational injury requirements.

Historical commission medical claims data provided a Texas workers' compensation mix of services for use in the analysis. This utilization pattern was applied to the commercial market (health maintenance organization, preferred provider organization, point of service, and indemnity plans) and Medicare reimbursement levels, establishing an estimated reimbursement for a workers' compensation case mix. This reimbursement was expressed as a percent of charges and as a percent of Medicare reimbursement. Information considered by Ingenix in the development of its analysis included:

* Commission historical claims data available for the years 1999 through 2002;

* The Mercer/Foster Higgins National Survey of Employer-Sponsored Health Plan 2001, which summarized enrollment and market share information for commercial managed care plans in Texas;

* Texas commercial indemnity and managed care reimbursement rates from Ingenix Employer Group for the years 1999, 2000 and 2001;

* Ingenix proprietary national managed care payer data regarding volume of services, charged and allowed reimbursement amounts to estimate the level of ASC business compared to outpatient, and ASC allowed-to-charge ratios compared to outpatient allowed-to-charge ratios, from 2001 data;

* National Center for Health Statistics and Bureau of the Census data to estimate the covered lives in the 2002 Texas commercial insurance/managed care market;

* Data published in 2001 by InterStudy Publications, which provided national commercial managed care reimbursement rates;

* Data published by the American Hospital Association from 1997-2001, which provided hospital outpatient charges per service;

* Source Book of Health Insurance Data for 2002; and

* Medicare reimbursement amounts, from 1999 for hospital outpatients and 2001 for ASCs.

ASC market reimbursement percentages were based on a mix of services that were equivalent to the Texas workers' compensation mix of services and reimbursement rates trended forward to 2003, and ultimately 2004. Ingenix also trended forward the Medicare ASC reimbursement rates to 2004. Ingenix concluded, as a result of its market analysis, that if current reimbursement trends continue, in 2004 Texas workers' compensation ASC claims will be reimbursed at approximately 320% of 2004 Medicare reimbursement. Ingenix also projected that 2004 commercial market reimbursement for the same mix of claims would be approximately 274% (not including indemnity plans) to 293% (including indemnity plans) of 2004 Medicare reimbursement.

In setting the recommended PAF range, Ingenix considered whether to include indemnity experience in the commercial market experience. While Ingenix found no difference in standards of living between people with commercial indemnity experience and injured workers, there are several reasons to consider excluding indemnity experience:

* Commercial indemnity represents only about 4% to 5% of the combined Medicare and commercial market. Removing commercial indemnity from the analysis removes experience that is higher than 95% of the payment levels for people of a similar standard of living.

* Payments for commercial indemnity plans are disproportionately higher than payments for the rest of the market, indicating that commercial indemnity payments are atypical of the commercial market experience.

* Statutory requirements set forth in §413.011 mandate that payment be made no higher than would be paid by or for people with similar standards of living.

* No cost controls are in place in the commercial indemnity market, and the Texas workers' compensation law mandates that in setting the fee structure, consideration be given to cost control.

Although commercial indemnity plans provide coverage for individuals with standards of living similar to the rest of the commercial market, including the data from these plans would increase the PAF because more weight would be placed on commercial reimbursement rates, thus reducing the impact of the lower Medicare payments. In contrast, the indemnity market share currently represents a small, decreasing fraction of the overall market, with payment levels far exceeding those in other commercial policy types, suggesting that they are uncharacteristic of the commercial market and, therefore, should be excluded. Excluding indemnity plans would decrease the PAF because less weight would be placed on commercial reimbursement rates, thus increasing the impact of the lower Medicare payments.

In order to provide the most comprehensive range of fair and reasonable reimbursement rates, and address the statutory requirement for cost control and prohibition against paying higher than would be paid by or for persons with similar standards of living, Ingenix excluded the indemnity experience at the lower end of the range and included it at the higher end of the range.

Ingenix initially recommended a 2003 range of 230% (not including indemnity plans) to 250% (including indemnity plans). Upon the commission's request for 2004 projections, Ingenix recommended the 2004 PAF range of 237% (not including indemnity plans) to 264% (including indemnity plans) of Medicare for ASC reimbursement. However, Ingenix's recommended reimbursement range did not contain an explicit reduction for security of payment or for extraordinary encouragement of medical cost control related to reimbursement rates. Consequently, Ingenix indicated that if the commission were to choose a different balance of the statutory objectives, implementation of the ASC rule with PAFs outside the recommended ranges (i.e., 90% of the 237% low endpoint, up to 110% of the 264% of the high endpoint within the ASC recommended range) would be appropriate and meet the statutory standards.

Subsequent to the rule adoption on April 15, 2004, ASCs expressed concerns regarding various components of the rule and their relationship to the overall reimbursement. These concerns included the site of service limitations tied to the Medicare List incorporated into the rule, as well as concerns regarding implant reimbursement. At the August 19, 2004 public meeting, the commissioners directed agency staff to revisit the sites of service and implant issues in light of new information submitted by system participants.

The commission requested public input on these two issues by:

* Posting a notice on the commission's website;

* Mailing the same notice in a letter to all Texas licensed ASCs;

* Providing the notice in all insurance carrier representative boxes;

* Requesting utilization and reimbursement data for CPT codes not currently on the ASC list of Medicare approved procedures (Medicare's List);

* Requesting utilization and reimbursement data for implantables; and

* Establishing a commission email address specifically for electronic submission of information.

The notice, "Public Request for ASC Information" was posted August 27, 2004. The notice stated the commission was exploring two specific areas within §134.402 for potential amendment: (1) amending Medicare's List for the inclusion/exclusion of procedures with appropriate ASC group payment; and (2) exploring reimbursement options for implantable devices. The commission requested information that would help determine if such considerations can be safely, appropriately and economically performed in an ASC setting, given the agency's rules and statutory mandates.

The commission received approximately 50 responses representing 20 separate entities. The responses were summarized and presented to an ASC Focus Group comprised of representatives from ambulatory surgical center providers, implant device supplier, insurance carriers, and self-insured businesses. Meeting on October 13, 2004, the ASC Focus Group reviewed and discussed the information received and the issues in general. However, the ASC Focus Group did not reach a consensus.

Despite a lack of consensus from the ASC Focus Group, agency experts and other staff conducted in-depth analyses of the new information received to that point and drafted a preliminary version of possible rule amendments to serve as a primary topic of discussion for a follow-up ASC Focus Group meeting.

The follow-up ASC Focus Group meeting was held on October 27, 2004 to discuss draft amendments to the rule in anticipation of formally proposing amendments in November 2004. Again, no consensus was reached. Some ASC Focus Group members recommended: a higher PAF, allowances for procedures to be performed in an ASC facility that are not on Medicare's List, a higher reimbursement for surgically implanted devices whether reimbursed separately or included in the ASC case rate by Medicare, and a retroactive effective date of September 1, 2004. Conversely, other ASC Focus Group members expressed concerns that such recommendations will increase administrative burdens and medical costs, and will ultimately negate the cost control measures of the existing rule (required under the Act).

Following the second ASC Focus Group meeting, the commission staff posted a pre-proposal draft rule for informal public input on the commission's website from November 2, 2004 through November 10, 2004. The commission reviewed the input and other available information, sought clarification, proposed amendments at the November 2004 public meeting, and now adopts these rule amendments.

The commission believes that the adopted rule will provide an effective regulatory framework for ambulatory surgical centers under the Texas workers' compensation system.

The commission is required by Texas Labor Code §413.011 to apply exceptions or minimal modifications necessary for adaptation of the Medicare methodology to the Texas workers' compensation system. Medicare payment policies may retroactively alter payment amounts of previously paid claims and require the Medicare system participants to re-adjudicate claims and reconcile payments. The commission determined that such retroactive payment policies would create undue administrative burdens if applied to the Texas workers' compensation system. The adopted rule requires the use of the most current Medicare policies in effect when the services were provided, including Medicare's site of service restrictions, with the exception of retroactive payment policies (no change from the rule adopted April 2004). The adopted amendments add minimal modifications to that exception by including procedures to the ASC List of Medicare Approved Procedures, and separate reimbursement for surgically implanted devices.

Texas Labor Code §413.011 requires the commission to adopt necessary conversion factors or PAFs to take the diverse statutory requirements into account in establishing a fee guideline that uses the federal Medicare reimbursement methodology. Additionally, the commission must take into account economic indicators in health care and the requirements found in subsection (d) of §413.011. The statute also states that the commission shall not adopt a PAF based solely on those PAFs developed by CMS. The commission adopted a multiplier, or PAF, of Medicare reimbursement rates for the reimbursement of ASC facility services to satisfy the statutory requirements.

The rate adopted establishes fair and reasonable reimbursement that is designed to ensure continued access to quality care, along with appropriate medical cost control. Ingenix also stated that in certain instances, going outside the recommended range to meet statutory requirements would be appropriate. Given the data available for analysis, Ingenix indicated that anywhere down to 90% of the low endpoint and up to 110% of the high endpoint of the recommended ASC range would be an appropriate "extended range." Ingenix noted that points in the extended range satisfactorily balance the complex statutory objectives, and the rate adopted in this rule is within the Ingenix extended range. To further address cost containment efforts provided by the statute, the commission adopted a PAF within the extended range.

The PAF multiplier for ASCs is considerably higher than the 125% multiplier provided in §134.202, the commission's Medical Fee Guideline, which covers reimbursement of professional medical services provided within the Texas workers' compensation system. There are several reasons for this. Unlike professional medical services, whose cost inputs are continuously updated by CMS, Medicare has not significantly revised ASC cost inputs since 1994. Moreover, the percentage of Medicare patients who receive ASC services (surgeries) is significantly less than the percentage of Medicare patients who receive professional medical services (typically, physician services). Finally, Medicare reimbursements for professional medical services are generally within the range of payments made by commercial payers; however, Medicare reimbursements for ASC services are well below the range of payments made by most commercial payers for those services. Thus, while the resulting multipliers are different in the two contexts, they are consistent with one another to the extent that the commission has determined that reimbursement for the two types of services is appropriate at the low end of the range of reimbursement provided within the commercial market.

The commission will in the future propose fee guidelines for outpatient facility services, and amendments to the current inpatient fee guideline. Inpatient hospital services are currently reimbursed under the existing commission rules that provide for per diem payments. Ingenix has noted that the current inpatient methodology is reasonably standardized but does not reflect the recent statutory requirement to use Medicare reimbursement methodologies. Ingenix also noted, at the time of its October 2003 report, that outpatient hospital and ASC payments were not standardized in the commission system, or the market in general, and the lack of detail in the available data makes it difficult to determine the current mix of services that are being delivered. Consequently, Ingenix recommended that the commission adopt a separate PAF for each setting (inpatient hospital, outpatient hospital, and ASC), based on Medicare reimbursement methodology and policies in accordance with the statutory mandates, resulting in standardization of all three facility fee guidelines, once adopted or revised. Because the relationship of the Medicare reimbursement to the commercial market varies between inpatient, outpatient, and ASC services, it is likely that the PAF proposed for the inpatient hospital and outpatient hospital facility fee guidelines will differ from the PAF adopted for ASCs in this rule.

In setting the ASC fees in this rule, the commission used Medicare fees as a reference and considered commercial market payments as indicative of economic indicators in health care, as required by the statute. The commission determined "fair and reasonable" is not based solely on the market value of services provided to injured employees. Fair and reasonable compensation in the Texas workers' compensation system is a balance of all the required components of the Act. These are rigorous statutory requirements, which are not easily balanced. In balancing the statutory mandates and objectives, the commission considered numerous issues, with the goal of establishing fair and reasonable fees that will assist in achieving effective medical cost control.

To help in understanding the full picture, the commission has addressed the background and basis for the rule, and requirements of the current rule, including those parts and issues that are not the subject of this rulemaking.

Rule 134.402 establishes reimbursements for ASC health facility services. The rule provides a standardized reimbursement method and billing procedures by aligning the workers' compensation reimbursement structure with the structure used by the CMS. The rule provides minimal modifications within this CMS structure to meet occupational injury requirements.

No amendments to (a) were proposed, other than the effective date for these amendments. Subsection (a) of the adopted rule provides for the reimbursement of health care facility services, as defined by the CMS, other than professional medical services, provided in an ASC on or after September 1, 2004. Paragraph (a)(2) provides for an amended effective date of April 1, 2005 for the amendments in paragraphs (e)(2), (e)(3), and (e)(4), and subsection (f). Subsection (a) also provides that the policies and reimbursement methodologies in effect for Medicare on the date a service is provided are the policies and reimbursement methodologies to be used in the Texas workers' compensation system. Subsection (a) requires use of the most recent payment policies adopted by the Medicare program for compliance with commission rules, decisions, and orders is required. This will prevent the Texas workers' compensation system from falling out of synchronization with Medicare and will achieve the standardization goals established in Texas Labor Code §413.011. However, specific provisions contained in the Act and commission rules shall take precedence over any conflicting provision adopted or utilized by CMS in administering the Medicare program. Pursuant to §408.021 of the Texas Labor Code, injured employees are entitled to all health care reasonably required by the nature of the injury as and when needed to cure or relieve the effect naturally resulting from the compensable injury, promotes recovery or enhances the ability of the employer to return to or retain employment. To the extent that this entitlement may differ from the entitlement of the Medicare recipients, the decision of the commission through its dispute resolution process must take precedence over the provisions adopted or utilized by CMS in administering the Medicare program. Subsection (a)(3) states that: "Specific provisions contained in the Texas Workers' Compensation Act (Act), or Texas Workers' Compensation Commission (commission) rules, including this rule, shall take precedence over any conflicting provision adopted by utilized by CMS in administering the Medicare program. Exceptions to Medicare payment policies for medical necessity may be provided by commission rule. Independent Review Organization (IRO) decisions regarding medical necessity are made on a case-by-case basis. The commission will monitor IRO decisions to determine whether commission rulemaking action would be appropriate."

There is a change from the text of subsection (a) as proposed. The adopted revision of paragraph (a)(2) changes the effective date of these rule amendments from March 1, 2005 to April 1, 2005, thereby allowing system participants adequate time to prepare for these rule amendments. The commission again clarifies nothing in these amendments would have retroactive effect.

No changes to subsection (b) were proposed. Subsection (b) requires system participants to utilize the Medicare reimbursement methodologies, models, and values or weights, including its coding, billing, and reporting payment policies for coding, billing, reporting, and reimbursement of health facility services provided in the Texas workers' compensation system. This allows for the basic Medicare program provisions to be applied with any additions or exceptions necessary for the adaptation to the Texas workers' compensation system. The Medicare program is not a static system. Medicare policies change frequently. To achieve standardization it is necessary to use the Medicare billing and reimbursement policies as they are modified by CMS. Adoption of policies in effect on a particular date would require participants in the Texas workers' compensation system to bill and reimburse in a manner different from the current Medicare system and the standardization required by the statute would be eliminated. However, Medicare also makes some policies retroactive, which is not workable for the workers' compensation system that has approximately 250 insurance carriers. Therefore, the rule, in compliance with the statute, did not adopt the retroactivity aspect of Medicare payment policies, and instead requires the use of the Medicare policies in effect on the day that a service was provided.

No changes from the text of subsection (c) were proposed. Subsection (c) establishes the method to be used for determining the MAR for ASC health facility services in the Texas workers' compensation system. In establishing the PAF for the rule, which is 213.3% of Medicare, the commission previously considered the statutory requirements and objectives and utilized Medicare data, current commission reimbursement levels, and available commercial payer information. As stated in the April 2004 adoption preamble, the adopted PAF is the low limit of the extended range of acceptable fair and reasonable reimbursements included in the Ingenix report and reflects the commission's statutory responsibility related to effective medical cost control and fair and reasonable reimbursement. The adopted PAF is in the range of commercial reimbursement. Ingenix estimated that 2004 ASC reimbursement under current commission rules (requiring fair and reasonable reimbursement) equals approximately 320% of 2004 Medicare reimbursement. Additionally, Ingenix estimated commercial (HMO/PPO/POS/Indemnity) payer reimbursement equal to a range of 168% to 564%. This commercial range produces a weighted average of approximately 274% (not including indemnity plans) to 293% (including indemnity plans) of Medicare reimbursement. With Medicare added to the commercial market, the weighted average for ASC services trended to 2004 is 237% (not including indemnity plans) to 264% (including indemnity plans) of Medicare reimbursement. This identified range (237% to 264%) was extended in the Ingenix report to 213.3% to 290.4% to recognize the potential for the commission to emphasize a different balance of the statutory objectives than that emphasized by Ingenix.

There are no changes from the text of subsection (d) as proposed. Adopted subsection (d) provides that the reimbursement for ASC services is the lesser of the MAR amount regardless of billed amount, or the facility's and payer's workers' compensation negotiated and/or contracted amount that applies to the billed service(s).

There are changes from the text of subsection (e) as proposed, which reformatted and expanded the current rule. Subsection (e) addresses the exceptions and minimal modifications to the Medicare payment policies.

As adopted, amended paragraph (e)(1) reformatted the language, which states that Texas will not incorporate any retroactive portions of Medicare payment policy changes.

There are changes from the text of paragraph (e)(2) as proposed. Amended paragraph (e)(2) supplements Medicare's List with additional procedures, and the associated group assignments (e.g., Medicare Group 1-9). These additions were proposed following review and approval by the commission Medical Advisor. After receiving the various recommended procedures for an ASC setting from the public request for information, staff compared the list with the procedures that were currently allowed in an ASC setting and the number of times that these procedures were performed. Additional information was received and considered regarding those procedures commonly performed for the workers' compensation population in ASCs. As a result of the review of recommended procedures, discussions during the focus group meetings, and input from the Medical Advisor, staff believes that the adopted list reflects those items that can not only safely be performed in an ASC setting, but also are appropriate for that setting. To prevent unnecessary charges, the adopted list excludes procedures that are bundled within another primary procedure. To determine the appropriate reimbursement group for these procedures, staff assigned groups, which were consistent with the reimbursement groups for similar procedures, including ASC input where available. In order to ensure the proper administrative actions by ASCs and insurance carriers, the individual procedures are referenced by the applicable American Medical Association's Current Procedural Terminology (CPT) codes. Subparagraph (e)(2)(F) has been changed from proposal to reflect Medicare's proposed inclusion of CPT code 29873 in payment group 3, rather than the rule's proposed payment group of 4. The CPT code has not been deleted because the likely CMS implementation date will occur after the effective date of this rule revision. Proposed subparagraph (e)(2)(K) has been deleted. After additional consideration of comments, fluoroscopy has been deleted from the list of commission-approved procedures because it does not qualify as a surgical procedure and is a radiological code. Further, proposed CPT code 76000 is noted as commonly miscoded according to the Ingenix 2004 CPT Expert, consequently including only one fluoroscopic code is likely to encourage inappropriate coding in order to obtain additional reimbursement. Fluoroscopy is a service furnished by ASC staff in connection with a covered surgical procedure. The Medicare ASC reimbursement methodology includes most diagnostic or therapeutic items or services in the group case rate. Additionally, Medicare Hospital Outpatient Prospective Payment System (HOPPS) generally bundles fluoroscopic services with a more extensive surgical procedure. This means no additional reimbursement is provided for these procedures.

There are no changes to the text of paragraph (e)(3) as proposed. Amended paragraph (e)(3) allows a service that is not included on Medicare's List, or on the commission's List at paragraph (e)(2), to be performed in an ASC by prospective agreement between the carrier, the doctor, and the ASC, occurring before, during, or after preauthorization. This will allow ASCs the opportunity to present to carriers the cost effectiveness of performing certain procedures in an ASC setting, which currently are not on Medicare's List or on the commission's List at paragraph (e)(2). Details that must be included in an agreement are specified to minimize disputes, which add costs to the system and drain the commission's resources. Flexibility in the process is provided to allow use of the timing and manner of negotiation that suits the particular case.

There are no changes to the text of paragraph (e)(4) as proposed. Amended paragraph (e)(4) allows a separate reimbursement for surgically implanted, inserted, or otherwise applied devices at the lesser of the manufacturer's invoice amount or the net amount (exclusive of rebates and discounts) actually paid for such device to the manufacturer by the ASC. Reimbursement for the cost of medical supplies related to the surgical procedure is included in the group case rate payment and is not included under this provision. The ASC is required to certify that the billed amount meets this standard, using specific certification language provided in the proposed paragraph.

The amendment providing reimbursement for implantables is a targeted approach to address situations where the cost of an implantable, by itself, exceeds the ASC group case rate or the MFG rate allowed in the workers' compensation system. Assuring sufficient reimbursement for these specific items enhances access to ASC services for injured workers. Although the Medicare system includes limited additional reimbursement for implantables, it was generally accepted in the ASC Focus Group meetings that orthopedic procedures were performed relatively infrequently in an ASC setting for the Medicare population. The limited Medicare reimbursement for high-cost, high-tech implantables associated with orthopedic procedures was cited as a primary reason for this suppressed utilization. The information provided by some of the ASC Focus Group members highlighted the high-cost of surgically implanted devices due to technology advances and medical cost inflation. The amended rule enhances consistency of reimbursement for surgically implanted devices by implementing a cost-based reimbursement, similar to the inpatient hospital methodology.

This fee guideline requires that provider billing must include a certification statement that the amount sought represents its actual costs (net amount, exclusive of rebates and discounts). This information should facilitate the billing process by providing cost information with the original billing. Consequently, processing times should improve, and confusion related to implant costs should decrease, which should additionally decrease the opportunity for disputes. The implant cost certified by the ASC is subject to insurance carrier or commission audit and verification.

There are no changes to the text of subsection (f) as proposed. Amended subsection (f) references that insurance carriers may conduct audits under §133.302 and §133.303 (relating to Preparation for an Onsite Audit and Onsite Audits) if they wish to challenge whether the certified amount referenced in subsection (e)(4) of these proposed amendments actually reflects the standard given in that subsection. Also, it is reiterated that the Medical Dispute Resolution process under §133.307 (relating to Medical Dispute Resolution of a Medical Fee Dispute) may be a forum where disputes concerning the certified amount under subsection (e)(4) are argued.

The ability to audit is an important check and balance feature related to reimbursement of the invoice cost. The audit allows the carrier to verify the actual cost of an item and auditing and assists the commission in the statutory requirements related to effective medical cost control. Additionally, members of the ASC Focus Group agreed that auditing was an acceptable trade off when combined with additional reimbursement.

Former subsection (f) concerning severability is now subsection (g), and there are no changes to the text of subsection (g) as proposed.

Comments generally supporting amendments to §134.402 as proposed were received from the following groups: Central Park Surgery Center; Clear Fork Surgery Center; East Houston Surgery Center; Medtronics; Northeast Baptist Surgery Center; NorthStar Surgical Center; Surgery Center of Duncanville; Symbion; Texarkana Surgery Center; and Texas Mutual Insurance Company.

Comments generally opposing or concerned with amendments to §134.402 as proposed were received from the following groups: Alamo Heights Surgery Center; Ambulatory Surgery Association of Texas; Ambulatory Surgery Center of Tyler; American Insurance Association; Calallen Orthopaedics L.L.P.; Christus, Santa Rosa Surgery Center; Corpus Christi Outpatient Surgery; Dallas Anesthesiology Association; Dallas Surgical Partners; Denton Surgicare; Doctors Outpatient Surgicenter; Flahive, Ogden & Latson; Garland Eye Associates, P.A.; Genesee Affiliates; Grapevine Surgicare; Heath SurgiCare; Insurance Council of Texas; Kirby Surgery Center; MacArthur Surgery Center; Mary Shiels Hospital; Memorial Herman Surgery Center Northwest; Memorial Northwest Otolaryngology; Metroplex Surgicare; North Texas Surgery Center; Northwest Houston Surgical Association; Park Cities Surgery Center; Property Casualty Insurers Association of America; San Marcos Surgery Center; Shannon Surgery Center; Smith & Nephew; South Austin Surgery Center; Southwest Podiatry, LLP; Specialty Surgery and Pain Center; Surgery Center of Arlington; Surgery Center of Lewisville; Texan Surgery Center; Texas Ambulatory Surgery Center Society; Texas Association of Business; Texas Mutual Insurance Company; Texas Sports Medicine and Orthopeadic Group; The Austin Diagnostic Clinic; The Urology Institute; United Surgery Center Southeast; United Surgical Partners International; and Valley View Surgery Center.

Comments neither generally supporting nor opposing amendments to §134.402 as proposed, but suggesting changes or asking questions were received from the following groups: Ambulatory Surgery Association of Texas; Alamo Heights Surgery Center; Ambulatory Surgery Center of Tyler; Calallen Orthopaedics, L.L.P.; Central Park Surgery Center; Christus; Santa Rosa Surgery Center; Clear Fork Surgery Center; Corpus Christi Outpatient Surgery; Dallas Anesthesiology Associates; Dallas Surgical Partners; Denton Surgicare; Doctors Outpatient Surgicenter; East Houston Surgery Center; Foundation West Houston Surgery Center; Foundation Surgery Affiliates; Garland Eye Associates, P.A.; Genesee Affiliates; Grapevine Surgicare; HealthSouth Corporation; Heath Surgicare; Heritage Eye Center; Insurance Council of Texas; La Vista Solutions, LLC; MacArthur Surgery Center; Mary Shiels Hospital; Medtronics; Memorial Herman Surgery Center Northwest; Memorial Northwest Otolaryngology; Metroplex Surgicare; Mirage Medical Group; North Texas Surgery Center; Northeast Baptist Surgery Center; NorthStar Surgical Center; Northwest Houston Surgical Association; Orthopedic Surgery Pavilion; Park Cities Surgery Center; San Marcos Surgery Center/Kirby Highland Lakes Surgery Center; Shannon Surgery Center; Smith & Nephew; South Austin Surgery Center/San Marcos Surgery Center; Southwest Podiatry, LLP; Special Surgery of Houston; Specialty Surgery and Pain Center; Surgery Center of Arlington; Surgery Center of Duncanville; Surgery Center of Lewisville; Surgical & Diagnostic Center; Symbion; Texan Surgery Center; Texarkana Surgery Center; Texas Ambulatory Surgery Center Society; Texas Association of Business; Texas Mutual Insurance Company; Texas Sports Medicine and Orthopeadic Group; The Austin Diagnostic Clinic; The Clinic for Special Surgery; The Urology Institute; United Surgery Center Southeast; United Surgical Partners; United Surgical Partners International; Valley Baptist Medical Center; Valley View Surgery Center; and Whitley Penn.

Summaries of the comments and commission responses to the proposed rule amendments are as follows:

Subsection (a)

COMMENT: Commenters recommended the rule amendments be retroactive to the original rule effective date, September 1, 2004. Commenters stated that this practice of implementing retroactive changes is often used by the Centers for Medicare and Medicaid Services (CMS) when adjustments are made to Medicare's physician fee schedule. This would allow ASCs to more easily transition and recover some of the costs associated with the original rule change.

RESPONSE: The commission disagrees with commenters' recommendation to apply a retroactive date to this amended rule. Many commenters requested that these amendments be retroactive to September 1, 2004, which was the effective date of the original rules. The commission declines to make this change. The commission notes that the Texas Constitution states that "no bill of attainer, ex post factor law, retroactive law, or any law impairing the obligation of contracts, shall be made" [Tex. Const., Art. I, Sec.16]. As a matter of policy, the commission believes that system participants involved in the ASC reimbursement rate issue need to be able to know what rates are in effect at any given time so that informed decisions can be made regarding matters like whether appeals are pursued during billing processing and during medical dispute processes. Also, it is likely that retroactive application of these amendments would lead to increased disputes due to retroactive adjustments.

Subsection (b)

COMMENT: Commenter recommended that the American Academy of Orthopedic Surgeons (AAOS) Complete Global Surgery Data be the standard for application of the multiple procedure rule.

RESPONSE: The commission disagrees there is a need to recognize AAOS Complete Global Surgery Data to be the standard for application of the multiple procedure rule. Adoption of AAOS Complete Global Surgery Data would contradict the CMS National Correct Coding Initiatives (NCCI) and would apply a different set of rules to ASCs and surgeons paid under the MFG.

Subsection (d)

COMMENT: Commenter recommended adding "billed amount" since requiring carriers to pay more than the billed amount does not achieve the objective of cost control. Commenter recommended deleting the "lesser of" provision and requiring reimbursement to be either the MAR or a negotiated rate.

RESPONSE: The commission disagrees with the recommendations. The CMS prospective payment methodology is based on a case rate concept, which recognizes that at times reimbursement will likely be different than the billed amount. Sometimes this reimbursement will be less than, sometimes more than, the billed amount. This concept encourages the efficient delivery of care without an unnecessary utilization of resources. The commission disagrees that the "lesser of" provision should be deleted from the rule. This provision facilitates cost control by setting an upper limit on reimbursement.

Subsection (e)(2)

COMMENT: Commenter generally supported the added procedures codes, and stated, "we are pleased to see that TWCC added some non-covered codes that the Medicare methodology did not have."

RESPONSE: The commission agrees that the proposed amendments of subsection (e) are an appropriate amendment to the rule.

COMMENT: Commenters recommended CPT code 76005 be added to the commission's List of procedures to be performed in an ASC, and be placed in Medicare's Group 9. Other commenters recommended CPT code 76005 be added and placed in Medicare's Group 1, in part due to the CMS NCCI edits, and because it requires the use of the most costly piece of ASC equipment, a C-arm, which is commonly used on injured workers. CPT code 76005 is defined as "fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural, transforaminal epidural, subarachnoid, paravertebral facet joint, paravertebral facet joint nerve or sacroiliac joint), including neurolytic agent destruction." Commenter recommended CPT code 76005 be used in lieu of proposed CPT code 76000. Other commenters opposed the proposed inclusion of CPT code 76000 and suggested that for consistency in both training and administration of the rule, the procedure should remain global. Commenters advised that CPT code 76000 is a radiological procedure, which would only be performed in an ASC as a part of a more extensive surgical procedure, and should not be subject to ASC facility reimbursement. Commenter advised that most diagnostic or therapeutic items or services, such as this code, are considered inclusive of the ASC facility fee, and further noted that NCCI edits deem 76000 as global to over 700 other procedures. Commenter opined that radiological services that are not global to other procedures should remain reimbursable per §134.202.

RESPONSE: The commission declines to replace CPT code 76000 with CPT code 76005 or add CPT code 76005 to the commission's List. After full consideration of comments received and after researching the matter further, CPT code 76000, which was proposed to be added, (fluoroscopy) has now been deleted from the commission's List because it does not qualify as a surgical procedure and is a radiological code. Further, CPT code 76000 is noted as commonly miscoded according to the Ingenix 2004 CPT Expert, consequently, including only one fluoroscopic code is likely to encourage inappropriate coding in order to obtain additional reimbursement. Fluoroscopy is a service furnished by ASC staff in connection with a covered surgical procedure. The Medicare ASC reimbursement methodology includes in the group case rate, most diagnostic or therapeutic items or services (such as CPT code 76000). Additionally, Medicare HOPPS generally bundles fluoroscopic services with a more extensive surgical procedure. This means no additional reimbursement is provided for these procedures. Regarding commenter's opinion that radiological procedures should remain reimbursable according to §134.202, the commission clarifies that the proposed radiological procedure has been deleted from the adopted rule.

COMMENT: Commenters opposed the inclusion of any proposed surgical procedure not approved by CMS (Medicare) to be performed in an ASC setting, and advised such deviations compromise the CMS methodology as applied to Texas through §413.011 of the Act. Commenter further recommended that Medicare's determination be given presumptive weight. Commenter indicated Medicare's List prohibition was intended to discourage the shift of services from physician offices to ASCs, and commenter recommended the commission should also strive toward patient safety and prevention of shifting procedures to a different setting that results in greater reimbursement amounts.

RESPONSE: The commission disagrees that supplementing Medicare's List to meet Texas workers' compensation system needs negatively impacts the Medicare's List methodology. The additions to Medicare's List impact only a limited number of CPT codes, maintain the CMS criteria as presumptive weight for over 2400 CPT codes, and are intended to facilitate certain procedures that previously have been provided in an ASC setting. The commission disagrees that Medicare's List was only developed to discourage a shift of services from physician offices to ASCs, as the CMS methodology considers many other factors in modifying its list. The commission agrees that patient safety and quality care is a significant factor in the workers' compensation system. The additions to commission's List have previously been performed in the ASC setting, and were reviewed and approved for inclusion by the commission's Medical Advisor.

COMMENT: One commenter suggested inclusion/exclusion of procedures to the commission's List beyond what's on the current Medicare's List will become a recurring theme for the commission each time CMS updates their list or when health care providers demand further changes. Commenters additionally advised that CMS has an established procedure for timely updating their list, and CMS is required to do so every two years. CMS is currently in the process of an update for services provided on or after July 1, 2005.

RESPONSE: The commission disagrees that careful consideration of "minimal modifications" to the rule under §413.011 of the Act, with the public's input, is inappropriate in this rulemaking or would be inappropriate in the future. Each time CMS updates its list, the rule includes such updates as stated in paragraph (4) of subsection (a) of the rule. Further, the commission has a responsibility to abide by the statutory requirement of reviewing and, if necessary, revising its medical policies and fee guidelines. The commission believes that these amendments are needed now, given the uncertainty of content and timing for any pending changes to CMS.

COMMENT: Commenters observed that the rule as proposed would have the unintended consequences of unbundling Medicare's List as established by CMS for the sole purpose of seeking a higher reimbursement. Commenters recommended the commission adhere to and not modify CMS' scheduled updates and methodology, which prevents unbundling.

RESPONSE: The commission disagrees that the creation of a commission's List within the rule will result in the unbundling of procedures. Although members of the ASC Focus Group recommended additional reimbursement for some procedures currently bundled into a primary procedure code, the commission did not include any of these procedures in the commission's List. The commission does not encourage unbundling, and clarifies that the minimal modifications made to Medicare's List do not encourage inappropriate unbundling and subsequent overpayment.

COMMENT: Commenters opposed additions or deletions from Medicare's List, stating the commission provided no reasonable basis, objective or consistent criteria for them. Commenter further stated that without providing the criteria for selection, it would appear the commission had insufficient expertise to make such modifications.

RESPONSE: The commission disagrees that it provided no reasonable basis/criteria for selection of additions or deletion from Medicare's List. The commission also disagrees that it has insufficient expertise to make such modifications. The supplements to Medicare's List in paragraphs (2) and (3) of subsection (e) of the rule constitute what the commission considers "minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements." The commission's proposal preamble cited that by the expansion of the number of services allowable in an ASC setting, the commission increases the injured worker's ASC access to procedures that are not on Medicare's List. In addition, by allowing the procedures to be performed in an ASC setting, the commission increases flexibility for system participants and promotes provision of services in a setting that ultimately lowers costs to the system and system participants. The site of service flexibility enhances the cost containment efforts of the commission to meet the requirements of the Act. This is especially important considering the documented high medical cost per claim in the Texas workers' compensation system, which also was outlined in the commission's previous April 2004 adoption preamble of §134.402. The commission compiled and evaluated information submitted by ASCs, carriers, and ASC Focus Group members. The commission also conducted its own research, which was evaluated with the input and expertise of the commission's Medical Advisor. Further, the commission clarifies that it sought the expertise of system participants through a data call, and then established an ASC Focus Group that was comprised of health care providers, including physicians and ASCs, and insurance carriers. Additionally, a device manufacturer participated in the ASC Focus Group meetings and assisted the commission with recommended amendments to the rule as proposed. Reasons for individual amendments to the rule are given throughout this preamble and the December proposal preamble for these amendments.

COMMENT: Commenters opined that the proposed deviations from the Medicare's List constitute more than a "minimal modification," are unrelated to any conditions specific to occupational injuries as required by statute, and are consequently beyond the statutory authority granted the commission.

RESPONSE: As previously stated, the commission disagrees that supplementing Medicare's List to meet workers' compensation system needs constitute more than a "minimal modification." The commission's List impacts only a limited number of CPT codes, maintains the CMS criteria as presumptive weight for over 2400 CPT codes, and is intended to facilitate certain procedures that previously have been provided in an ASC setting. The additions to the commission's List have previously been performed in the ASC setting, and were reviewed and approved for inclusion by the commission's Medical Advisor. The commission further disagrees with commenters' statement regarding "occupational injuries" as a statutory criterion. The statute directs the commission to use health care reimbursement policies and guidelines that reflect the standardized reimbursement structures found in other health care delivery system, including Medicare, with minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements. This the commission has done, as detailed throughout this preamble.

COMMENT: Commenter suggested the proposed commission's List is contrary to the commission's requirement to control medical costs because the significant advantage for access to ASCs is to ensure the service can be performed safely in that environment and is less costly. A commenter indicated there has been no showing of any injured worker not having received a medically necessary procedure because it is not deemed appropriate to be performed in an ASC setting, and such expansion of ASC services is not necessary to ensure injured workers' access to medical care.

RESPONSE: The commission disagrees that the commission's List is contrary to the commission's requirement to control medical costs. Each procedure is grouped into a prospectively determined case rate, which inherently controls costs. By adopting Medicare's List and the multiplier, the ASC reimbursement was projected in the initial proposal of §134.402 to decrease overall ASC reimbursement by approximately $31 million. The reimbursement for the additional CPT codes is unlikely to unduly impact overall system costs because of their relatively infrequent use in the system. For those procedures added to the commission's List, access is anticipated to increase due to scheduling and other patient/doctor conveniences afforded by allowing an ASC to perform these procedures.

COMMENT: Commenter specifically opposed the inclusion of procedure codes 11750, 11760, 20526, 20552, and 64405 (subparagraphs A, B, C, D, and I of (e)(2) of the rule proposal) noting that CMS indicates these procedures are most commonly performed in a doctor's office setting, which the commenter agrees with, and stated that inclusion will guarantee inappropriate migration from the doctor's office to the ASC setting, which in turn will cause increased medical costs to the system without incremental benefit to the injured worker. Commenter stated, "The more significant events may be performed in an outpatient setting."

RESPONSE: The commission disagrees. In general, prior to the implementation of this rule in September 2004, there were no restrictions regarding site of service. Further review of the commission's medical billing database indicated these procedures were performed in several settings, including ASCs. This history suggests that it is unlikely that these procedures will automatically or inappropriately shift from the doctor's office to an ASC setting. The amendments continue to allow these procedures to be performed in an ASC; however, reimbursement is now standardized according to this fee guideline. The rates reimbursed prior to September 1, 2004, were on average 50% more than the current reimbursement rate.

COMMENT: A commenter noted CMS' current proposal to include procedure code 29873 to its list.

RESPONSE: The commission agrees and recognizes that CMS is proposing to add this procedure to its list. The commission has also determined that it is appropriate for this procedure to be performed in an ASC setting, and thus the rule has been changed from proposal to adoption to reflect Medicare's inclusion of CPT code 29873 in payment group 3. The CPT code has not been deleted from the commission's List because it is likely CMS implementation date will occur after the effective date of this rule revision.

COMMENT: Commenter generally supports addition of the procedure codes that the Medicare methodology does not include.

RESPONSE: The commission agrees that the additional CPT codes included in the rule amendment are an appropriate minimal modification to Medicare's List in order to meet the reimbursement requirements for occupational injuries as well as the other factors of §413.011 of the Act.

COMMENT: Commenter stated the proposed modifications do not cover the ASC's costs.

RESPONSE: The commission disagrees that the assigned group number does not cover the costs associated with the proposed modifications because the commission has received no independent cost data to determine actual costs in Texas ASCs. Unlike hospitals, ASCs do not publicly report operating expenses and revenues. Additionally, any cost information provided by an ASC is unique to that facility and not necessarily indicative of the cost structure or profitability of any other ASC facility. Without this cost-based information, the commission has relied on Ingenix's expertise in analyzing market reimbursement, and the commission has set reimbursement within the range recommended by Ingenix.

Through this rule amendment, the commission clarifies that the additional procedures are those that have been commonly performed in ASCs prior to this rule's implementation, and further clarifies that the rate of reimbursement is 213.3% over that of Medicare's established rate. Additionally, ASC Focus Group members, which included numerous ASC representatives, recommended the procedures. Several of the additional codes are currently commonly performed in other settings with no, or minimal, facility reimbursement. Based on this information and the ASC comments of efficiency and low cost, the additional reimbursement ($710 (Group 1 rate of $333 x 213.3 %) at a minimum per procedure) is not appropriate.

COMMENT: Commenter opposed the grouping of the 11 proposed procedures for inclusion and suggested that the 11 codes should be grouped to a higher group. Commenter recommended that if additional procedures are added to the commission's List they be grouped to a higher group.

RESPONSE: The commission disagrees that the additional codes should be regrouped. The groupings are based on the relationship to the other codes on Medicare's List and in general, are reflective of the relative time and resources necessary for the procedure. Additionally, unlisted codes are included to allow flexibility for certain procedures, and are grouped with similar procedures to discourage inappropriate use of the unlisted codes to increase reimbursement. The commission disagrees that the proposed 11 procedures should be grouped to a higher group. The commission clarifies that if further additional codes should be added, they will be grouped using the same concept.

COMMENT: Numerous commenters recommended other common codes be included in the commission's List (but not provided in written public comment) as recommended by various ASCs prior to rule proposal, and commenters recommended the commission adopt the previously recommended Texas Ambulatory Surgical Center Society's group assignments.

RESPONSE: The commission disagrees that other CPT codes should be included in the commission's List at this time. As previously stated in this preamble, and prior to proposal of this rule amendment, the commission requested and received from the public those procedures they requested to be added and indicated were commonly performed in an ASC setting. The commission evaluated the entire list of suggested procedures and removed those procedures that were already on Medicare's List; procedures that Medicare (CMS) determined could only safely be performed in an inpatient hospital setting; and in general, those procedures that had not been or had rarely been performed in the workers' compensation system in calendar year 2002. The commission discussed and received general support from the ASC Focus Group members as to the process for procedure removal from the broader list of suggestions. The commission then evaluated remaining procedure suggestions and further removed those, which through NCCI edits, are considered as bundled to a primary surgical procedure. The commission disagrees with the recommendations for group assignments provided by the Texas Ambulatory Surgical Center Society. The commission, with the input of the commission's Medical Advisor, utilized the previously described general concept in assigning groups to maintain consistency with Medicare's List. The final results are rule amendments, which satisfy the criteria of §413.011 of the Act.

COMMENT: Commenter recommended the specific procedure codes 62290, 72295, 20600, 20605, 20610, 72275, 27096, 24220, 27648, and 23350 be added to the commission's List. Commenter suggested these additional codes would assure mistakes are kept to a minimum, allowing them to be performed in an ASC setting would decrease the reimbursement allowance, which would benefit insurance carriers. Commenter further stated if these codes were to remain allowed to be performed just in a hospital outpatient surgery department setting, it would cause an increase in system expenditures.

RESPONSE: The commission disagrees with commenter's recommendation of additional procedures codes 62290, 72295, 20600, 20605, 20610, 72275, 27096, 24220, 27648, and 23350 to be included on the commission's List through this rule amendment. The previously described vetting process by the commission was thorough. Additionally, the commission disagrees that there is any proof or validity to the commenter's statement that the addition of these codes would necessarily reduce mistakes, and reduce ASC's monetary allowance. There is no set reimbursement for specific hospital outpatient surgical procedures that would support commenter's assertion that reimbursement for services provided in a hospital outpatient setting are more expensive than adding these procedures to the commission's List, and thereby reducing their costs to the system.

COMMENT: Commenter recommended the commission completely remove the Medicare site of service restrictions from the rule by allowing any and all ASC certified procedures to be performed in ASCs. Commenter recommended, for those procedures without assigned Medicare groupers, a provisional grouper assignment be allowed from 2 to 5, depending on the complexity of the procedure. Commenter's reason for this recommendation is that the adoption of Medicare's site of service restrictions in rule 134.402 does not meet the statutory requirement of setting fair and reasonable fee guidelines. Commenter further stated the commission rules should not re-distribute or re-direct patient flow preferentially from one type of site to another.

RESPONSE: The commission disagrees that alternative inclusion of all procedures and groupings for currently ungrouped procedures be applied in the Texas workers' compensation system. To do so would be contrary to the standardization requirements of the Act regarding Medicare methodology. Additionally, the commission's limited list assures that procedures are performed in settings appropriate to the complexity of the procedure and the safety of the patient. This standardization promotes consistency within the workers' compensation system, eliminating unnecessary administrative burdens and the potential for disputes based on site of service issues - all of which would be problems associated with the commenter's suggestion. The commission disagrees that incorporating the site of service restrictions does not meet "the statutory requirement of setting fair and reasonable fee guidelines." Section 413.011(a) of the Act states, "to achieve standardization the commission shall adopt the most current reimbursement methodologies, models and values, or weights used by the Health Care Financing Administration (now called the Centers for Medicare and Medicaid Services (CMS)) including applicable payment policies relating to coding, billing, and reporting, and may modify documentation requirements as necessary to meet the requirements of Section 413.053." Additionally, §413.011(d) states, "guidelines for medical services fees must be fair and reasonable and designed to ensure the quality of medical care and to achieve effective medical cost control...." Adoption of these rule amendments is consistent with these requirements of the Act. The commission disagrees that commission rules should not re-distribute or re-direct patient flow from one site to another, because re-directing services between sites is an essential tool the commission must use to assure services are provided safely and in appropriate settings and to assure effective medical cost control. There is nothing "preferential" about such commission actions, however. They are, rather, a function of the commission's following its statutory mandates as set out by the Texas Legislature.

COMMENT: Commenters opposed the inclusion of procedure codes 27599, 29999, and 64999 (subparagraphs E, G, and J of (e)(2) of the rule proposal) stating that their inclusion would lead to unbundling, and increase the abuse of "unlisted procedure codes," rather than use of more appropriate codes. Commenter provided an example of an injection being billed as code 64999, which is defined as "unlisted procedure, nervous system," and potentially reimbursed at a much higher rate. Commenter suggested inclusion of the codes at issue would result in increased audit and dispute costs to the system.

RESPONSE: The commission disagrees that inclusion of procedure codes 27599, 29999, and 64999 (subparagraphs E, G, and J of (e)(2) of the rule proposal) will lead to unbundling and increase the abuse of unlisted procedure codes. The commission clarifies that unlisted codes are included to allow flexibility for certain procedures, and are grouped with similar procedures to discourage inappropriate use of the unlisted codes to increase reimbursement. The commission disagrees that audit and dispute costs will increase. Adding these procedures assures their reimbursement when provided in an ASC setting, and eliminates confusion when these services are provided as a secondary procedure, or in lieu of a procedure already on Medicare's List.

COMMENT: Commenters expressed concern regarding procedure code 29873 (subparagraph F of (e)(2) of the rule proposal) and its proposed group assignment of 4 because CMS is currently in the process of proposing the same code for Medicare's List inclusion, only in group 3, and not group 4. A commenter recommended the commission defer to CMS' expertise and not deviate from the methodology used by CMS for group assignment, as it would set the stage for future deviations.

RESPONSE: The commission agrees with commenters' concerns and recommendations regarding the proposed inclusion of CPT code 29873 and corresponding group assignment. The commission recognizes that CMS is proposing to add this procedure to its list. The rule has been changed from proposal to reflect Medicare's proposed inclusion of CPT code 29873 in payment group 3.

COMMENT: Commenter asked if the codes proposed to be added to the commission's List would be assigned a Medicare group and paid from the established Medicare fees. Commenter additionally asked if the cost of grafting, anchors and screws would be paid separate from the procedure code 29873.

RESPONSE: The commission clarifies the additional procedure codes for inclusion in the commission's List, (e)(2) of the adopted rule, do have an assigned Medicare case rate group, which is multiplied by 213.3% for a reimbursement of Texas workers' compensation claims. The reimbursement of grafts, anchors and screws is reimbursed separately as clarified further in (e)(4) of the adopted rule.

COMMENT: Commenters opposed any payment that is based on Medicare fee schedules for ASCs and stated that the CMS ASC Grouper System is outdated.

RESPONSE: The commission disagrees that payments should not be based in part on Medicare. The commission is required by §413.011 of the Act to adopt the most current Medicare program reimbursement, methodologies, models, and values or weights, including its coding, billing, and reporting payment policies. The Medicare ASC reimbursement system model adopted by the commission fulfills these requirements.

COMMENT: Commenter specifically recommended procedure code 64999 (subparagraph J of (e)(2) of the proposed rule) be considered for higher reimbursement than the proposed group 1 category, as the reimbursement does not cover the cost of supplies and use of the ASC facility. Commenter advised that as an example, in the use of a Spine Cath, the catheter alone cost in excess of $1,000.00, yet it would be less expensive to have this procedure performed in an ASC than in a hospital outpatient surgery department setting.

RESPONSE: The commission disagrees that procedure code 64999 should be regrouped. The commission clarifies that such supplies as referenced by commenter are integral to the procedure and are consequently included in the group rate reimbursement. The groupings are based on the relationship to the other codes on Medicare's List and in general, are reflective of the relative time and resources necessary for the procedure. The commission clarifies that unlisted codes such as 64999 are included to allow flexibility for certain procedures, and are grouped with similar procedures to discourage inappropriate use of the unlisted codes to increase reimbursement.

COMMENT: Commenter opposed the commission's recommended group payment codes for the proposed additional list codes, and indicated a detailed explanation of the methodology used to assign these specific groups is lacking.

RESPONSE: The commission clarifies that the groupings are based on the relationship to the other codes on the Medicare's List and in general, are reflective of the relative time and resources necessary for the procedure. Unlisted codes, e.g., 64999, are included to allow flexibility for certain procedures, and are grouped with similar procedures to discourage inappropriate use of the unlisted codes solely to increase reimbursement.

COMMENT: Commenter opposed the inclusion of procedure code 63030 to the commission's List because of the increased safety risk of the surgery to the injured worker/patient if performed in any setting other than a hospital setting. Commenter additionally stated such inclusion would increase the number of fee disputes. Commenter asserted that this procedure has the potential for additional spinal procedures to be performed (e.g., 63035), with risk of complications, and consequently risk to the patient.

RESPONSE: The commission disagrees that CPT code 63030 should not be included on the commission's List. As previously stated in this preamble, and prior to proposal of this rule amendment, the commission requested and received from the public those procedures they requested to be added and indicated were commonly performed in an ASC setting. The commission evaluated the entire list of suggested procedures and removed those procedures that were already on Medicare's List, procedures that Medicare determined could only safely be performed in an inpatient hospital setting, and in general, those procedures that had not been or had rarely been performed in the system in calendar year 2002. The commission discussed and received general support from the ASC Focus Group members as to the process for procedure removal from the broader list of suggestions. The commission then evaluated remaining procedure suggestions and further removed those, which through NCCI edits, are considered as bundled to a primary surgical procedure. The commission, with the input of the commission's Medical Advisor, utilized the previously described general concept in assigning groups to maintain consistency with Medicare's List. The commission disagrees that medical disputes will significantly increase as a result of this addition to the Medicare List. During preauthorization and according to subsection (e)(3) of the rule, health care providers and carriers have the responsibility to discuss all procedures to be performed during a single operative session. The commission recognizes that any surgical procedure has a risk for complications. Health care providers have a responsibility to consider the risk for complications when determining a particular setting for a particular patient.

COMMENT: Commenters stated proposed amendments that establish a separate list of codes for ASC reimbursements, and the additional carve-out for implant reimbursements, are more than a "minimal modification." Commenters stated the proposed amendments far exceed the minimal modifications authority granted to the commission by §413.011(a) of the Texas Labor Code. Commenters stated that Medicare ASC payment policies determine which procedures may be performed in an ASC and include those bundled items (certain implants) in the base fee as opposed to those unbundled items, which are reimbursed according to Medicare's DMEPOS fee schedule.

RESPONSE: The commission disagrees. As previously stated, the supplements to Medicare's List in paragraphs (2), (3) and (4) of subsection (e) of the proposed rule, constitute what the commission considers "minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements." Although the commission has supplemented the Medicare ASC methodology, this methodology is still maintained as the primary framework of the guideline. The statute directs the commission to use health care reimbursement policies and guidelines that reflect the standardized reimbursement structures found in other health care delivery systems with minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements. The remainder of §413.011 of the Act gives further criteria, which are met by these rule recommendations.

The commission also disagrees that the commission's List will enable ASCs to unbundle procedures. The commission discouraged unbundling by removing those suggested procedures, which through NCCI edits were considered as bundled to a primary surgical procedure. In general, prior to the implementation of this rule in September 2004, there were no restrictions regarding site of service and consequently any preauthorized service could be performed in an ASC. Further review of the commission's medical billing database indicated these procedures were performed in several settings, including ASCs. This history suggests that it is unlikely that these procedures will automatically or inappropriately shift from the doctor's office to the ASC setting. The amendments continue to allow these procedures to be performed in an ASC; however, reimbursement is now standardized according to this fee guideline.

Subsection (e)(3)

COMMENT: Commenter recommended the elimination of CMS site of service restrictions from rule 134.402, to allow physicians to decide where best to treat their patients and to avoid administrative burden and contentious situations. Such restrictions in the commission's rule are not within the agency's statutory authority because it is "not fair and reasonable," and because the agency does not have the authority to "redirect patient flow." Commenter recommended allowing any and all procedures to be performed in ASCs. Commenter further recommended assigning a grouper for procedures without CMS assigned groupers as follows: "Group 2 - No break in skin (e.g., joint manipulation; or fracture dislocation reduction); Group 3 - Percutaneous; Group 5 - Open or endoscopic surgery (e.g., all repair, revision or reconstruction procedures, including fracture ORIF and dislocation open reductions); Group 4 - All other open or endoscopic surgery."

RESPONSE: The commission disagrees that CMS site of service restrictions (Medicare List) should be eliminated, for reasons previously stated in this preamble. Eliminating Medicare's List is contrary to the standardization and Medicare methodology requirements of the Act. Additionally, a restrictive list assures that procedures are performed in settings appropriate to the complexity of the procedure and the safety of the patient. These minimal modifications promote consistency within the workers' compensation system, eliminating administrative burdens and the potential for disputes based on site of service issues - all of which would be problems associated with the commenters' suggestions. The commission further disagrees that the sites of service restrictions do not meet "the statutory requirement of setting fair and reasonable fee guidelines." The commission clarifies that §413.011(a) states, "to achieve standardization the commission shall adopt the most current reimbursement methodologies, models and values, or weights used by the Health Care Financing Administration (now called CMS) including applicable payment policies relating to coding, billing, and reporting, and may modify documentation requirements as necessary to meet the requirements of Section 413.053." Additionally, §413.011(d) states, "guidelines for medical services fees must be fair and reasonable and designed to ensure the quality of medical care and to achieve effective medical cost control...." Adoption of these rule amendments is consistent with these requirements of the Act. The commission disagrees that commission rules should not re-distribute or re-direct patient flow from one site to another because re-directing services between sites is an integral part of the Medicare methodology and is an essential tool the commission must use to assure services are provided safely and in appropriate settings and to assure effective medical cost control.

The commission disagrees with commenter's recommendation to provide groupings for procedures without CMS or commission assigned groups. The commission clarifies that subsection (e)(3) allows the carrier and ASC to negotiate the reimbursement amount for procedures without CMS or commission assigned groups. The agreed upon reimbursement amount could conceivably be based on the alternative groupings mentioned above.

COMMENT: Commenter recommended that any procedure identified by Medicare as an office-based procedure, which is billed as the primary procedure in an ASC, must have prior authorization between the ASC and the insurance carrier, otherwise it is not billable. The secondary procedure (e.g., nail bed repair after repairing the smashed finger) would not require preauthorization.

RESPONSE: The commission clarifies that Medicare does not restrict procedures to an "office only" category. Additionally, by statute §413.014, any outpatient surgical or ambulatory surgical services, as defined by commission rule 134.600, must be preauthorized.

COMMENT: Commenters opposed the process outlined in (e)(3) of the proposed rule for negotiation of procedures not on Medicare's or the commission's Lists.

RESPONSE: The commission disagrees. The negotiation process allows the health care provider and carrier to reach agreement for special circumstances not envisioned in the development of the commission's List. This additional flexibility increases access to care for injured workers when parties agree to site of service and reimbursement. Nothing in these amendments forces parties to enter into such an agreement.

COMMENT: Commenters stated the following about the proposed negotiation process: will further complicate and delay the preauthorization and retrospective review audit; carrier staff are not trained in the appropriate reimbursement for ASC services; carrier staff would be put in the position of "second-guessing" CMS; a facility would need to seek an ASC agreement, and then preauthorization; and, site of service decision requires an initial determination if the procedure is medically necessary (normally a preauthorization request does not contain all of the information needed to make a decision on both issues) compounded by a three-day timeframe to make the decision. Commenters further stated that the proposed process would: compromise CMS methodology and standards; could potentially delay treatment; and, cause more time for carriers to process requests. Commenter stated that the proposed amendment is not an appropriate format or methodology to establish the medical necessity of a procedure or reimbursement rate.

RESPONSE: The commission disagrees that the proposed negotiation process will complicate and delay preauthorization and retrospective review. The process is designed to enhance flexibility and encourage communication between health care providers and carriers when reviewing requests for procedures not on Medicare's or the commission's Lists. Although not required, system participants are allowed the flexibility to request, approve, and utilize alternate sites, as determined to be appropriate, by agreement between the health care provider and carrier. Further, the commission disagrees that CMS methodology and standards are compromised. Adoption of these rule amendments maintains the concept of the Medicare List while allowing deviations from Medicare's and the commission's Lists when determined to be medically appropriate and financially prudent. This is consistent with the medical necessity and effective cost control concepts of the Act, as well as the "minimal modifications" concept in §413.011. The commission disagrees that the training of carrier staff is a significant problem since carriers, prior to September 1, 2004, evaluated all ASC services (including items not on Medicare's or the commission's Lists) and determined fair and reasonable reimbursement. Since the opportunity for negotiation is voluntary, the carrier may choose to develop its internal processes and training to supplement existing procedures based on past experience. Section (e)(3) provides considerable flexibility on both the timing of, and process for, negotiation.

COMMENT: Commenter stated that the proposed amendment regarding negotiation would increase medical disputes and appeals.

RESPONSE: The commission disagrees that the proposed amendment would increase medical disputes and appeals because negotiated agreements allow reconciliation of potential disagreements prior to the provision of services. As previously stated, entering into such agreements are voluntary.

COMMENT: Commenter stated that the proposed amendment regarding negotiation would increase administrative costs; increase costs to employers, and ultimately the workers' compensation system.

RESPONSE: The commission disagrees that the process will increase administrative costs, costs to employers, or the workers' compensation system since medically necessary services, if not provided in an ASC setting, will be provided in an alternate office or hospital setting. Any difference in administrative costs is likely to be minimal and is potentially offset by the ability to negotiate reimbursement.

COMMENT: Commenters also stated the proposed negotiation process could potentially cause the migration of procedures performed in a doctor's office, or in a hospital, to an ASC setting, resulting in overuse of ASC facilities due to financial incentives, and all without any additional benefits to the injured worker.

RESPONSE: The commission disagrees that an agreement between the health care provider, ASC, and carrier that includes the procedure, setting, and reimbursement will result in inappropriate use of ASC facilities. The purpose of this adopted amendment is to encourage negotiation and mutual agreement for medically appropriate and financially prudent decisions, all benefiting the injured worker. This is consistent with the medical necessity and effective cost control concepts of the Act.

COMMENT: Commenter disagreed that the proposed negotiation process is a "minimal modification" in Medicare payment policies and stated it is outside the commission's rulemaking authority.

RESPONSE: As previously stated, the commission disagrees that allowing the negotiation of a procedure, setting, and reimbursement as provided in (e)(3) of the rule proposal, is outside the commission's rulemaking authority. The statute directs the commission to use health care reimbursement policies and guidelines that reflect the standardized reimbursement structures found in other health care delivery systems, including Medicare, with minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements. The commission has maintained the Medicare methodologies as the primary framework for ASC reimbursement. The commission does not anticipate that these agreements will significantly impact the site of service provisions. Additionally, any agreements reached are anticipated to be consistent with the medical necessity and effective cost control concepts of the Act.

COMMENT: Commenter recommended the addition of language to offset the additional time it will take health care providers' staff to get ungrouped procedures approved and reimbursed. The recommended language is "Prompt payment within 15 days of preauthorized and contracted procedures being performed and billed...." to be inserted at (e)(3)(B) of the rule.

RESPONSE: The commission disagrees with the recommended language. Section 408.027 of the Act, Payment of Health Care Provider, specifies the applicable timeframes. However, negotiated agreements could include other specified timeframes and should be noted in the agreement between the carrier and the ASC, as per amended rule (e)(3)(B)(ii).

Subsection (e)(4)

COMMENT: Commenters opposed a separate reimbursement for implants, including some who opposed a separate reimbursement except when Medicare allows a separate implant payment, because such payments are not necessary to provide injured workers with reasonable access to quality medical care.

RESPONSE: The commission disagrees that the additional reimbursement for all surgically implanted devices is unnecessary to maintain or improve access to care. The amendment providing reimbursement for implantables is a targeted approach to address situations where the cost of an implantable, by itself, exceeds the ASC group case rate or the MFG rate allowed in the workers' compensation system. Assuring sufficient reimbursement for these specific items enhances access to ASC services for injured workers.

COMMENT: Commenters stated that the Medicare reimbursement rates for ASCs includes the costs of implantables, and that this was considered by the Texas Legislature when enacting HB-2600. Commenters stated that the rule amendment will result in over-reimbursing ASC services and increasing system costs without any additional benefit to injured workers permitting the ASC to unbundle its services - a practice forbidden by Medicare payment policies.

RESPONSE: The commission agrees that the Medicare system includes limited additional reimbursement for implantables. It was generally accepted in the ASC Focus Group meetings that orthopedic procedures were performed relatively infrequently in an ASC setting for the Medicare population. The limited Medicare reimbursement for high-cost, high-tech implantables associated with orthopedic procedures was cited as a primary reason for this suppressed utilization. The information provided by some of the ASC Focus Group members highlighted the high cost of surgically implanted devices due to technology advances and medical cost inflation. As previously stated, the reimbursement for implantables is a targeted approach to address situations where the cost of an implantable, by itself, exceeds the ASC group case rate or the MFG rate allowed in the workers' compensation system. Assuring sufficient reimbursement so that the ASC's cost of providing services involving these specific items is covered will enhance access to ASC services, which benefits injured workers. Consequently, the commission disagrees that this amendment will result in an over-reimbursement for an otherwise bundled or separately reimbursed item to ASCs for those orthopedic procedures involving surgically implanted devices.

COMMENT: Commenters stated that ASC fees set at 213.3% of Medicare plus a separate reimbursement for all implants would raise ASC fees above hospital inpatient fees for the same surgeries.

RESPONSE: The commission disagrees that separate reimbursement for implantables would necessarily reimburse more than hospital inpatient reimbursement for the same surgeries. Both hospital inpatient and ASC settings will now reimburse surgically implanted devices based on a "invoice cost" methodology. The hospital surgical per diem of $1,118 is not directly comparable to an ASC group rate. Overall, a two-day inpatient surgical stay (per diem with invoice cost plus 10% of implantables) is very similar to reimbursement in an ASC (when compared to the ASC Group 9 most expensive case rate with invoice cost of implantables). In general, in this comparison, services in groups 1 through 8 would likely be reimbursed less than a two-day inpatient surgical stay.

COMMENT: Commenter stated that logic used by the commission to arrive at this figure for implantable reimbursement is flawed and based on the commission's Rule 134.401, concerning Acute Care Inpatient Hospital Fee Guideline. Commenter summarized that rule's adoption preamble (22 TexReg 6268-69, July 4, 1997) included the percentage of billed charges approach in determining fees is ineffective; explained that the percent of billed charges does not achieve effective cost control because each hospital determines its own charges and can raise them far above costs, inflation, or what other payers pay. Further, hospital charges are not a valid indicator of a hospital's costs, and if reimbursement levels are based on a percentage of billed charges, a hospital or ASC can independently affect its reimbursement without its costs being verified.

RESPONSE: The commission disagrees and clarifies that billed charges are not a component of the adopted reimbursement methodologies for §134.402, Ambulatory Surgical Center Fee Guideline. The implant reimbursement is based on cost, certified by the ASC and subject to insurance carrier or commission verification and audit.

COMMENT: Commenter did not support the proposed "prosthetic device" reimbursement methodology, stating it is inconsistent with the requirements of Labor Code §413.011. Commenter said that continuing to reimburse ASCs for prosthetic devices under the provisions of §134.202 would provide a consistent reimbursement structure for such devices.

RESPONSE: The commission disagrees that the reimbursement methodology is inconsistent with §413.011 of the Act because the amended rule establishes fair and reasonable reimbursement based on Medicare methodologies to assure access to quality health care and enhance effective medical cost control. Subsequent to the original adoption of this rule, information was submitted to the commission which included cost information and taken with information previously submitted, led the commission to believe that there were some inadequacies regarding separately reimbursed devices under the provisions of §134.202. The commission disagrees that continuing to utilize the §134.202 methodology for surgically implanted devices in ASCs is appropriate. The amended rule enhances consistency of reimbursement for surgically implanted devices by implementing a cost-based reimbursement, similar to the inpatient hospital methodology.

COMMENT: Commenter opined that the methodology change from a fee schedule for separately reimbursed surgically implanted devices to an "actual cost-driven" methodology will increase costs incrementally because some items are currently being reimbursed in the system at 125% (DMEPOS) fee schedule.

RESPONSE: The commission agrees that a change in reimbursement methodologies will result in additional reimbursement for surgically implanted devices. As previously stated, this change was necessary as a targeted approach to address situations where the cost of an implantable, by itself, exceeds the ASC group case rate or the MFG rate allowed in the workers' compensation system. Assuring sufficient reimbursement so that the ASC's cost of these specific items is covered will enhance access to ASC services, which benefits injured workers. Subsequent to the original adoption of this rule, information was submitted to the commission which included cost information and taken with information previously submitted, led the commission to believe that there were some inadequacies regarding separately reimbursed devices under the provisions of §134.202.

COMMENT: Commenter stated that under the proposed amendments, costs will increase since certain implantables, (i.e., pins, rods, screws, and plates), which were previously reimbursed as part of the group case rate will now be reimbursed separately at the lesser of the manufacturer's invoice amount or the net amount. Commenter stated that a separate reimbursement of cost or cost plus payment is inconsistent with effective medical cost control, inconsistent with the requirements of the Act, and constitutes a major change in Medicare payment policy of paying 125% of the Medicare DMEPOS Fee Schedule only for selected implants.

RESPONSE: The commission disagrees with commenters' assertions for reasons previously stated concerning the targeted approach to amending reimbursements for surgically implanted devices. The commission disagrees that the amended reimbursement methodology is inconsistent with effective medical cost control, and other requirements of the Act. The amended methodology impacts only surgically implanted devices. Without a change in reimbursement methodology, these cases could potentially be diverted to more costly settings, and if provided in a hospital setting, would likely be paid at a cost plus 10% basis, which is more than the amended methodology. The commission further disagrees that the change in methodology is a major change in Medicare payment policy of paying 125% of the Medicare DMEPOS Fee Schedule. The amendments better establish consistency of reimbursement for surgically implanted devices between the hospital and ASC settings. Subsequent to the original adoption of this rule, information was submitted to the commission which included cost information and taken with information previously submitted, led the commission to believe that there were some inadequacies regarding separately reimbursed devices under the provisions of §134.202.

COMMENT: Commenter stated that allowing an ASC to obtain payment for whatever cost it incurs for an implant: removes any incentive for the ASC to negotiate for lower costs; creates an environment of fraud and abuse; and creates an opportunity for suppliers to inflate costs of implants in a way audits may not detect.

RESPONSE: The commission disagrees that the amended rule relating to reimbursement of surgically implanted devices removes incentives for an ASC to negotiate lower costs. Such negotiations for lower cost expenditures are a common business practice that ASCs are likely to integrate into all aspects of their procurement process. The commission disagrees that the amended provisions will create an environment of fraud and abuse or an opportunity for suppliers to inflate costs. ASCs are required by commission rule 134.600 to obtain preauthorization approval for procedures and services performed in an ASC, including surgically implanted devices to be included as a component of certain requested surgical procedures. To further establish effective medical cost control and deter fraud, the commission additionally, through this amended rule, requires an ASC to certify that the amount of the surgically implanted device(s) represents the ASC's actual cost (net amount, exclusive of rebates and discounts). The certification is subject to verification and audit by the insurance carrier or the commission.

COMMENT: Commenters were pleased with proposed implant reimbursement and the addition of non-covered codes, and stated it is a step in the right direction and an improvement over the current guideline.

RESPONSE: The commission agrees that the adopted amendments regarding reimbursement for surgically implanted devices and the addition of commission-approved codes is an appropriate modification of the rule, given information submitted to the commission since the original rule 134.402 was adopted.

COMMENT: Commenters recommend that surgically implanted devices and supplies be reimbursed at a "reasonable amount" that includes case processing, accounting, collections, and cost of capital. Commenter defined "case processing" as the clerical, procedural steps in ordering and acquiring a device for an implant, including: obtaining preauthorization; the pricing for the facility's charge master; the staff time of a nurse or physician spent in ordering the device; costs associated with shipping, handling and for the expense of returning excess inventory if incurred; and staff time managing the inventory of devices. Commenter described "accounting" as staff time spent processing Accounts Paid and Accounts Receivable that are associated with the purchase of, and payment for, the devices. Commenter stated that staff time must be spent on performing follow-up work with carriers to receive payment for devices. Commenter defined "cost of capital" as the management of inventory in order to keep adequate supplies available for physicians, which commenter says can be a considerable cost. Commenter continued that this cost is a function of both the purchase price of the device and the amount of waiting time required for the "high-tech" device to be paid for by a carrier.

RESPONSE: The commission disagrees with commenters' recommendation to include additional factors in determining the reimbursement for surgically implanted devices and supplies. Setting the Medicare ASC group case rate at 213.3% and reimbursing the purchase price of the device is adequate to compensate for case processing, accounting, collections, and cost of capital. This fee guideline requires that provider billing must include a certification statement that the amount sought represents its actual costs (net amount, exclusive of rebates and discounts). This information should facilitate the billing process by providing cost information with the original billing. Consequently, processing times should improve, and confusion related to implant costs should decrease, which should additionally decrease the opportunity for disputes.

COMMENT: Commenter recommended reimbursement at cost plus 10%, with an upper limit of at least $750-$1,000 per invoiced item to account for the true acquisition costs of higher cost devices.

RESPONSE: The commission disagrees with the commenters' recommended reimbursement of cost plus 10% with an upper limit of at least $750-$1,000 per invoiced item. Setting the Medicare ASC group case rate at 213.3%, and reimbursing the actual cost of the device is adequate to compensate for acquisition cost because administrative and acquisition costs are included in the case rate.

COMMENT: Commenters recommended surgically implanted devices and supplies (SIDS) be reimbursed at cost plus 25% to cover the expense of shipping, ordering, stocking and maintaining items for an indeterminate amount of time in inventory. ASCs are the only medical venue not allowed to cover some of these additional costs.

RESPONSE: The commission disagrees with the commenters' recommended reimbursement of cost plus 25%. As previously stated, setting the Medicare ASC group case rate at 213.3% and reimbursing the actual cost of the device is adequate to compensate for the expense of shipping, ordering, stocking and maintaining items for an indeterminate amount of time in inventory.

COMMENT: Commenter recommended a specific language change to state, "or other device suppliers," and "all bills for such devices" to permit other suppliers of devices that may perform purchasing and billing services on behalf of ASCs to be reimbursed for those devices.

RESPONSE: The commission disagrees that other device suppliers should be allowed to bill the carrier for surgically implanted devices. Addition of this language would add complexity to the billing and reimbursement process, would be difficult to administer, and would not be standardized throughout the industry. Adding complexity would likely lead to increased auditing requirements resulting in delayed payments and potentially increase disputes. In addition, the Act limits the definition of health care provider, which precludes recommended language addition in this rule.

COMMENT: Commenter recommended a revision to add language, "Extraordinary Supplies greater than $100" due to the high costs of implants and other "extraordinary" supplies that should be recognized by the commission as a financial burden, and in order to ensure a process for reimbursement of these costs. All items can be processed in a manner in which invoices can be attached as verification of costs and reimbursed accordingly.

RESPONSE: The commission disagrees. Surgically implanted devices were specifically identified as a potential cost barrier for ASC provision of certain orthopedic cases, often with costs exceeding the group rate. "Supplies" were not identified in ASC Focus Group meetings as a cost driver or barrier. Setting the Medicare ASC group case rate at 213.3% is adequate to compensate for ASC supply costs.

Subsection (f)

COMMENT: Commenter opposed an ASC covering the costs associated with an audit initiated by an insurance carrier for implant billing and recommends that insurance carriers should pay for audits unless the ASC is proven fraudulent.

RESPONSE: The commission disagrees that reimbursement for health care provider audit costs should be addressed in this rule. As noted in the adopted rule, requirements for carrier on-site audits are addressed in §133.302 and §133.303, which are not open for comment in this rulemaking action.

COMMENT: Commenter is opposed to insurance carriers auditing the books of ASCs to determine if the billing reflects the true net cost of implants, and stated the audit potentially costs more than the amount recoverable.

RESPONSE: The commission disagrees that carriers should not be allowed audit authority. The ability to audit is an important check and balance feature related to reimbursement of the invoice cost. The audit allows the carrier to verify the actual cost of an item and auditing assists the commission in the statutory requirements related to effective medical cost control. Additionally, members of the ASC Focus Group agreed that auditing was an acceptable trade off when combined with additional reimbursement.

COMMENT: Commenter stated proposal creates an environment for fraud and abuse, allows an opportunity for inflated implant costs, (e.g., creative accounting/pricing), and has a potential for resulting kickbacks. An audit would not detect these discrepancies, and is of no overall benefit to the injured worker.

RESPONSE: The commission disagrees that the ability to audit implant costs is of no value to the workers' compensation system and therefore, the injured worker. As previously stated, the audit provisions are an important check and balance feature of the workers' compensation system. Although it is unlikely that audits will expose every instance of fraud, abuse, or "creative" accounting/pricing, audits are a valuable component to ensure system compliance with commission statute and rules.

General

COMMENT: Commenter supported the commission's decision to make amendments to the rule.

RESPONSE: The commission agrees that the adopted amendments are an appropriate modification of the rule.

COMMENT: Commenters opposed the proposed rule and recommended its withdrawal. Commenters stated the proposed rule will result in unnecessary and inappropriate additional medical costs; will not increase access to quality care or improve injured workers access to outpatient surgery services; will lead to more medical disputes and appeals to SOAH which will cause substantial expenses for the commission and the system, and is of no benefit to carriers or employers.

RESPONSE: The commission disagrees with the recommendation to withdraw the rule because the adopted amendments are an appropriate modification of the rule. The commission disagrees that the adopted rule will result in unnecessary and inappropriate additional medical costs. The extensive analysis provided by Ingenix indicated that the PAF is well within the range of commercial reimbursement levels for ASCs. There is no indication that there are issues of access to quality medical care within the ASC commercial market. The commission disagrees that the rule amendments do not increase injured workers access to outpatient surgery services, both hospital outpatient and ASC services. Improving the overall reimbursement for ASCs with regard to implantables increases the economic viability of procedures requiring those implantables and as such increases access and availability. The commission disagrees that rule amendments will lead to more medical disputes and appeals to SOAH and clarifies that with consistency in the reimbursement methodology, the number of fee disputes should ultimately decrease. The commission is confident that this rule amendment will ultimately reduce the number of disputes requests and any associated appeals of commission decisions to the SOAH level. With the established fee guideline, amended as described in this preamble, reimbursement for all system participants should be predictable and consistent. Rule 134.402, with these amendments, balance all relevant factors under the Act. The commission anticipates that aggregate medical costs will decrease in the system and there will be fewer ASC dispute requests and decreased probability of ongoing or new litigation associated with ASC services. The commission disagrees that the rule amendments are of no benefit to carriers or employers. For reasons previously stated throughout this preamble, appropriate reimbursement improves the workers' compensation system and ultimately benefits all system participants.

COMMENT Commenters expressed concern that amendments were proposed in response to complaints from several physician-owned ASCs that are not satisfied with the current reimbursement rate and lobbied their legislators and the commission for further payment increases. Commenter stated that proposal is a windfall for ASCs, implant suppliers, and surgeons at the expense of injured workers and employers. Commenters stated that it is a display of bad judgment and distorted priorities for the commission to respond to these "squeaky wheels" and devote its limited time, staff resources, and rulemaking process to respond to the greed of a small number of health care providers.

RESPONSE: The commission clarifies that the existing rule was initially reviewed as a response to ASC stakeholder concerns. The commission reviewed those concerns and formed an ASC Focus Group comprised of ASCs, carriers, implant device manufacturer, and employer. The commission carefully considered the ASC Focus Group input regarding ASC issues with specific focus on Medicare's List of approved procedures and reimbursement for surgically implanted devices. These rule amendments reflect input from the ASC Focus Group, stakeholders and public commenters to establish the most appropriate reimbursement to facilitate access to quality ASC care while still adhering to the statutory mandate for cost control. The commission disagrees that the rule amendment is a windfall for ASCs, implant suppliers, and surgeons at the expense of injured workers and employers. Although reimbursement to ASCs will increase as a result of these amendments, the added reimbursement of implantables is consistent with the cost plus reimbursement provided in the hospital inpatient setting. Assuring sufficient reimbursement enhances access to ASC services, which benefits injured workers. The commission disagrees that the rulemaking activity was an ineffective use of staff time for an inappropriate purpose, for reasons stated throughout this preamble.

COMMENT: Commenters sought clarification as to what sort of "stability" was referenced in the proposal preamble, which stated, "insurance carriers will benefit from the amended rule as proposed with new commission approved procedures and assigned groupings, which lends certainty and 'stability' to the system." Commenters stated no facts or analysis were included in the proposal preamble that showed ASCs are currently financially unstable as a result of being paid 213.3% of Medicare rates for treating injured workers. Commenters further stated that unsubstantiated assertions by ASC owners do not constitute credible evidence of a reasoned justification.

RESPONSE: The commission clarifies the term stability referenced in the proposal preamble was used in the context of describing the proposed rule amendments as a process of continuing and augmenting the ASC Fee Guideline, adopted and implemented September 1, 2004, when previously there was none. As previously discussed, stability and standardization through the implementation of this guideline promotes consistency within the workers' compensation system.

COMMENT: Commenters stated that the amended rule proposal is inconsistent with the statutory authority of §413.011(d) because it would result in an ASC receiving a fee in excess of the fee charged for similar treatment of an injured individual of an equivalent standard of living (i.e., a Medicare patient) and paid by that individual or by someone acting on that individual's behalf.

RESPONSE: The commission disagrees that the adopted amendments would allow an ASC to receive a fee in excess of the fee charged for similar treatment of an injured individual of an equivalent standard of living, and disagrees that the amendments are inconsistent with the statutory authority of §413.011(d). The cap on workers' compensation fees is addressed in the statutory requirement that workers' compensation not pay in excess of what is paid on behalf of patients from populations with equivalent standards of living, except and to the extent that special features of workers' compensation require higher fees. It therefore permits consideration of any special features of workers' compensation and what additional payment, if any, they warrant. For example, the statutory requirement to take account of the increased security of workers' compensation payment permits consideration of what offsetting reductions in payments, compared with other payer systems that do not pay 100%, is warranted. Within these limits, the commission must consider how payments may be set to control medical costs without lowering the access to quality of medical care to injured workers that would affect quality care. The commission has determined these amendments meet the statutory standards.

COMMENT: Commenters argued that in accordance with §413.011(b), no reasoned justification was provided in the proposal preamble to prove: that the economic indicator (i.e., injured workers' access to quality health care) was necessary for this fee guideline to pay more than Medicare; that occupational injuries required these modifications; and failed to prove the full impact assessments of the proposed rule.

RESPONSE: The commission disagrees that the commission has not previously provided reasoned justifications as to why the economic indicator of injured workers' access to quality care was necessary for this fee guideline to pay more than Medicare, that occupational injuries required these modifications, and the assertion that the commission has failed to prove the full impact assessments of the rule. As previously stated and also addressed in the adoption preamble of April 2004 (28 TexReg 4191), the adopted PAF is the result of careful analysis by Ingenix and consideration by the commission. The commission considered the requirement of the Act in adopting the PAF by thoroughly analyzing Medicare reimbursement and commercial reimbursement for ASCs. This included both the reimbursement rates and market share. These factors combined allowed Ingenix to provide the commission with an appropriate range of PAFs. The PAF itself is well within the range of reimbursement accepted by ASCs in the commercial market. Additionally, the PAF was well within the estimated range of payments previously paid (i.e., prior to rule implementation) within the Texas workers' compensation system.

The commission clarifies that access to care for occupational injuries requires these rule amendments. The amendments increase flexibility for system participants and promote provision of services that ultimately lowers costs to the system and system participants. Improving the economic viability of providing certain procedures in an ASC setting by definition improves access to care balanced with cost control.

With regard to the alleged failed proof of the proposed rules' full impact, the commission anticipates that aggregate medical costs will decrease in the system with fewer ASC dispute requests, that there will be decreased probability of on-going or new litigation associated with ASC services, and that appropriate reimbursement improves the workers' compensation system and benefits all system participants, as discussed throughout this preamble.

COMMENT: Commenters opposed the amended rule as proposed for reasons that it exceeds the Act under §413.011(a), which provides for health care reimbursement policies and guidelines that reflect the standardized reimbursement structures found in other health care delivery systems, including Medicare, with minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements. Commenters further stated that the proposed rule makes major modifications, rather than minimal modifications, to these payment policies that significantly increase medical costs to the system.

RESPONSE: The commission disagrees that the rule amendments exceed the Act under §413.011(a). The supplements to Medicare's List in paragraphs (2), (3), and (4) of subsection (e) of the proposed rule constitute what the commission considers "minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements." These modifications increase flexibility for system participants and promote provision of services in a setting that ultimately lowers costs to the system and system participants, therefore enhancing the cost containment efforts of the commission to meet the requirements of the Act. This is especially important considering the documented high medical cost per claim in the Texas workers' compensation system, which also was outlined in the commission's previous April 2004 adoption preamble of §134.402, and the December proposal preamble of §134.402. Improving the economic viability of providing certain procedures in an ASC setting by definition improves access to care balanced with cost control. Thus the commission has maintained the statutory requirement to use health care policies and guidelines that reflect the standardized reimbursement structures found in other health care delivery systems, including Medicare, with minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements.

COMMENT: Commenter sought clarification as to what "fair and reasonable" rates are, and if there are fair and reasonable guidelines.

RESPONSE: The commission clarifies that the terminology "fair and reasonable" is contained within the Act, §413.011(d) and refers to the statutory requirement of the commission to ensure all fee guidelines are fair and reasonable.

COMMENT: Commenter was concerned that the commission found, in the 1997 Hospital Fee Guideline and in a number of other contexts, that payments based on a percentage of billed charges cannot achieve effective cost control because the amount of the billed charges is entirely within the control of the health care provider. Commenter stated that by basing the 213.3% of Medicare plus an implant reimbursement on payment made by commercial payers based on the percentage-of-billed-charges method, Ingenix has essentially recommended an ASC fee payment based on the percentage-of-billed-charges method.

RESPONSE: The commission disagrees. As previously stated, billed charges are not a component of the adopted reimbursement methodology for §134.402, Ambulatory Surgical Center Fee Guideline. The guideline bases the MAR calculation on the Medicare prospectively determined group case rate, not on billed charges from the ASC. Additionally, reimbursement associated with surgically implanted devices according to subsection (e)(4) is based on the actual certified cost paid by the ASC to the manufacturer, not on the ASC billed charges.

COMMENT: Commenter stated the costs to the system will be even more substantial than reflected in the fiscal note of the proposal preamble. Commenter expressed concern with the proposal preamble statement that the commission expects there to be a 8.7 to 13.5 million dollar cost increase per year once the proposed amendments are adopted, when actually it would be a lot more because some of the less honest ASCs and doctors will try to "game the system" when the proposed CPT codes are added.

RESPONSE: The commission clarifies that the estimated increases are a reasonable projection based on the information available to the commission. The commission agrees that providers' business models, in general attempt to maximize reimbursement. The commission's Compliance and Practices Division, its Fraud Unit, and the carrier's audit opportunities provide a means to minimize fraud and abuse in the Texas workers' compensation system.

The following comments are a listing of other issues raised by commenters. Because the PAF has not changed since the rule was originally adopted, these comments are beyond the scope of this rulemaking action and do not require a new, separate response under the Administrative Procedures Act. The reasons for selection of the particular PAF were explained thoroughly in the adoption preamble to the original rule (see 28 TexReg 4191, April 30, 2004). Subsequent to the adoption of that rule, information was submitted to the commission, which in the aggregate, taken with information previously submitted during the original rulemaking process, led the commission to believe that there were some inadequacies regarding reimbursements to ASCs that needed to be addressed. Stakeholder and Focus Group meetings were held and extensive discussions were conducted on these issues. The commission requested additional information from concerned entities. After careful analysis of available data, amendments to the rule were proposed and comments on that proposal were given full consideration. These amendments are the result of that process. The commission has determined, for all the reasons given elsewhere in this preamble that these amendments provide for appropriate compensation to ASCs in the Texas workers' compensation system. However, to assist persons in understanding the actions that led to the rule as it was originally adopted in April 2004, the commission has chosen to respond to the individual comments.

COMMENT: Commenters opposed the rule amendments and stated the most "glaring" problem with the proposed rule changes is the failure to address the payment adjustment factor (PAF). Commenters stated that the proposed modification will not allow adequate payment, would not cover ASC costs, and that injured workers would suffer.

RESPONSE: The commission disagrees that the PAF is inappropriate and should be addressed in the amended rule. The rationale for the PAF was outlined extensively in the §134.402 Adoption Preamble. The adopted PAF is the result of careful analysis by Ingenix and consideration by the commission. The commission considered the requirements of the Act in adopting the PAF by thoroughly analyzing Medicare reimbursement and commercial reimbursement for ambulatory surgery center services. This included both the reimbursement rates and market share. These factors combined allowed Ingenix to provide the commission with an appropriate range of PAFs. The PAF is well within the range of reimbursements accepted by ambulatory surgery centers in the commercial market. Additionally, the PAF is within the estimated range of payments currently made within the Texas workers' compensation system.

The commission disagrees that the PAF does not cover ASC costs. The commission has received no independent cost data to determine actual costs in Texas ASCs. Unlike hospitals, ASCs do not publicly report operating expenses and revenues. Additionally, any cost information provided by an ASC is unique to that facility, and not necessarily indicative of the cost structure or profitability of any other ASC facility. Without this cost-based information, the commission has relied on Ingenix's expertise in analyzing market reimbursement, and the commission has set reimbursement within the range recommended by Ingenix. The commission disagrees that the injured worker would suffer as a result of the PAF. The commission has maintained the 213.3% PAF and made other minimal modifications which increase reimbursement in an effort to assure sufficient reimbursement for ASC services and to enhance access to ASCs which benefits injured workers.

COMMENT: Commenter stated of the three places services can be performed, the ASC is the least expensive. Commenters opposed the low reimbursement rate and stated it was a "determination" against ASCs, and the first step to ensure that ASCs would not be able to compete with hospital outpatient departments. Commenter stated the commission does not monitor and/or hold hospitals accountable for costs.

RESPONSE: The commission agrees that the ASC should be the least intense venue for facility reimbursement and all health care providers should be reimbursed commensurate with actual costs based on resource consumption. Unlike hospitals, ASCs do not publicly report operating expenses and revenues. Cost information provided by an ASC is unique to that facility, and not necessarily indicative of the cost structure or profitability of any other ASC facility. Lacking independent cost data to determine actual costs in Texas ASCs, the commission has relied on market-based reimbursement to establish the PAF. The commission disagrees that the PAF will make ASCs non-competitive with hospital outpatient departments. For reasons previously stated, the Ingenix report indicated that the adopted PAF was well within the range of commercial reimbursement accepted by ASCs.

The commission disagrees that hospitals are not accountable for costs. The commission has adopted §134.401, which regulates reimbursement for inpatient hospital services. The commission has not yet adopted hospital outpatient fee guidelines. Ingenix estimated 2002 hospital outpatient reimbursement in the workers' compensation system at approximately 150% of Medicare reimbursement, which was significantly less than the estimated ASC reimbursement in 2002 at 320% of Medicare. This indicated a greater need to address ASC reimbursement than hospital outpatient reimbursement.

It should also be noted that sometimes a procedure may be most cost-effectively performed in a doctor's office (when it is medically appropriate to do so), and this is something the commission considered in adopting these amendments.

COMMENT: Commenter stated their ASC workers' compensation business had declined 12% since September 1, 2004, the date of this rule's implementation, and assumed the decline was due to cases being shifted to a more expensive setting (i.e., hospital outpatient departments) than an ASC. In addition, commenter stated that 20% of procedures by volume performed on workers' compensation patients are not currently reimbursed under the existing rule.

RESPONSE: The commission recognizes that business models may change as the result of implementation of new reimbursement methodologies. The commission has not received enough data to validate the commenter's assertion of a systemic decline in services provided in ASCs. However, since some services provided by ASCs prior to September 1, 2004, are not on Medicare's List, a decline in services is likely and appropriate. Additionally, there is no information to indicate the change of setting for those services. It should also be noted that sometimes a procedure may be most cost-effectively performed in a doctor's office (when it is medically appropriate to do so), and this is something the commission considered in adopting these amendments. Consequently, the commission cannot evaluate the commenter's assertion of movement to a more expensive setting.

COMMENT: Commenters stated the ASCFG is being revisited less than seven months after it was adopted and at a time when the commission has failed to complete "more important" rulemaking tasks it was given by the Legislature in 2001 and earlier.

RESPONSE: The commission disagrees that the rulemaking activity was an ineffective use of staff time for an inappropriate purpose, for reasons stated throughout this preamble.

COMMENT: Commenter recommended withdrawal of the proposed rule and that a new rule be proposed that establishes reimbursement at 100% of Medicare Hospital Outpatient Prospective Payment System (HOPPS) for ASCs and Hospital Outpatient. According to the commenter, this would comply with statutory requirements and fill "major gaps" in fee guidelines; and facility fees would be reimbursed for only those procedures Medicare authorizes ASCs to perform. Commenter stated this would be preferable to the proposed rule because there is no urgent need to amend the current rule, as there is no documented problem with injured workers' access to outpatient surgery facilities. Commenter also stated that by adopting HOPPS: ASCs and hospital will both be reimbursed equally for providing the same service which increases the fairness and reasonableness of the payment system; would not create a change in ASC billing practices; and, software to determine the payment due under the suggested methodology is available and easily obtained. Commenter states that HOPPS has been implemented with little difficulty and contains 808 APCs, making it much more precise in differentiating between procedures in the payment due than is the Medicare ASC payment mechanism.

RESPONSE: The commission disagrees because the statute requires the use of the most current Medicare reimbursement methodologies. The ASC group reimbursement methodology is the most current Medicare payment methodology for ASCs. The HOPPS system is not currently designed for ASC use and is not consistent with statutory requirements.

COMMENT: Commenters recommended the PAF be established at the highest level the commission is empowered to do so, which is the upper end (250% - 290% of Medicare) of the Ingenix range, (213% - 290% of Medicare). Commenter stated this would enable ASCs to cover their costs and remain in the workers' compensation system, which would result in quality providers reentering the workers' compensation system, thereby improving access to quality care.

RESPONSE: The commission disagrees with commenters' recommendation, as the PAF itself was not a proposed amendment to this rule. Nevertheless, the commission addressed this concern in the adoption preamble of April 2004 (28 TexReg 4191) and the adopted PAF is the result of careful analysis by Ingenix and consideration by the commission.

COMMENT: Commenters recommended use of Medicare rates as the benchmark for ASC fees, just as it did for the MFG, rather than using the methodology employed by Ingenix. Commenters stated the Medicare ASC fees meet the statutory criteria for workers' compensation fees for the same reasons that the Medicare professional fees meet those statutory criteria. Those reasons as provided by commenters included: March 2003 MedPAC reports indicate fees are high enough to be fair and reasonable and the number of ASCs providing services in the Medicare system has increased since the current Medicare ASC fee schedule was adopted; health care providers voluntarily choose to accept Medicare fee levels; Medicare fees ensure access to quality care as studies show the majority of health care providers accept Medicare payment levels; Medicare fees achieve effective medical cost control because they are the lowest in common use for a population with an equivalent standard of living; and the security of payment afforded by the workers' compensation system is greater than Medicare's because the workers' compensation system pays 100% of the appropriate reimbursement amount, while Medicare pays only 80%.

RESPONSE: The commission disagrees with commenters' recommendation, as the PAF itself was not a proposed amendment to this rule. Nevertheless, the commission addressed this concern in the adoption preamble of April 2004 (28 TexReg 4191) and the adopted PAF is the result of careful analysis by Ingenix and consideration by the commission.

COMMENT: Commenter was concerned that the administrative expense factors that supported a 125% conversion factor (CF) in the 2002 MFG adoption preamble support a much smaller CF (i.e., PAF) for ASC fees for several reasons: (1) additional reports and administrative functions required when treating workers' compensation patients create increased administrative costs for professionals, but is not the case for ASCs who are not required to file any reports beyond those required for Medicare; (2) additional training requirements for professionals practicing in the workers' compensation system caused some additional administrative expenses, but is not the case for ASCs as they are not required to receive any additional training to participate in the workers' compensation system; (3) the commission's claim that there will be reduced medical fee disputes as a result of this rule implementation; and (4) lack of electronic billing and payment increases administrative costs of workers' compensation as opposed to Medicare, but the commission previously stated that increased security of payment in the workers' compensation system offsets any additional costs.

RESPONSE: The commission clarifies that differing methodologies were used for the commission's rule 134.202, the 2002 Medical Fee Guideline (MFG), and this adopted rule. As previously stated in the initial rule 134.402 adoption preamble, the adopted PAF multiplier for ASCs is considerably higher than the 125% multiplier provided in the MFG, which covers reimbursement of professional medical services provided within the Texas workers' compensation system. There are several reasons for this. Unlike professional medical services, whose cost inputs are continuously updated by CMS, Medicare has not significantly revised ASC cost inputs since 1994. Moreover, the percentage of Medicare patients who receive ASC services (surgeries) is significantly less than the percentage of Medicare patients who receive professional medical services (typically, physician services). Medicare reimbursements for professional medical services are generally within the range of payments made by commercial payers; however, Medicare reimbursements for ASC services are well below the range of payments made by most commercial payers for those services. The methodology used by Ingenix in developing its recommendation stands alone and is not dependent on the methodologies used in previous reimbursement guidelines. The Medicare rate is the benchmark on which the reimbursement rate is built, but is neither a ceiling nor a floor. Development of the PAF is a balance of all the components of the Act. Thus, while the resulting multipliers are different in the two contexts, they are consistent with one another to the extent that the PAF adopted by the commission in each context is at the low end of the range of reimbursement provided within the commercial market.

COMMENT: Commenters were concerned that the reasons and explanations for rejecting the MFG methodology were flawed when provided by the commission in the April 2004 adoption preamble of §134.402. Commenters further provided varying thoughts for these concerns, including: (1) Medicare's failure to update 1994 cost data does not support setting ASC fees at 213.3% of Medicare fees plus a reimbursement for implants, when a recent study shows that Medicare ASC fees are not too low, and may be too high. (2) The fact that more Medicare patients receive professional services than ASC services does not distinguish Medicare from workers' compensation. (3) ASC fees based on fees paid by commercial payers fail to achieve effective cost control. (4) The methodology used to set the ASC fees are factually wrong and logically flawed because the Ingenix methodology ignores other states' workers compensation ASC fee schedules, some of which are at much lower percentages of Medicare ASC fees. (5) The Ingenix methodology relies, in effect, solely on commercial insurers' ASC payments. But commercial insurers are not required, as the commission is required, to achieve effective medical cost control. They do not have to achieve cost control because, unlike the commission, they can and do expect the higher costs to be passed on to employers and employees. (6) Ingenix excluded indemnity payer types when calculating averages, thereby lowering their reimbursement recommended range. (7) Commenter stated that according to a new national survey by Mercer Human Resources Consulting, employers' costs are rising by double digits, forcing employers to shift costs to employees. ["Shifting Burden Helps Employers Cut Health Costs," The Wall Street Journal (Dec. 8, 2003)]

RESPONSE: The commission disagrees that the rationale used in developing the ASC PAF is flawed. The methodology used by Ingenix to develop their recommendation stands alone and is not dependent on the methodologies used in previous reimbursement guidelines. The Medicare rate is the reference point from which the reimbursement rate is built, but is neither a ceiling nor a floor. Development of the PAF is a balance of all the components of the Act.

The commission disagrees with commenters' concerns. The adopted PAF is the result of careful analysis by Ingenix, which confirmed a significant misalignment of ASC reimbursement in the Texas workers' compensation system. The adopted PAF is the lower limit of the extended range of acceptable fair and reasonable reimbursements included in the Ingenix report and reflects the commission's statutory responsibility related to effective medical cost control and fair and reasonable reimbursement. The adopted PAF remains in the range of commercial reimbursement. Ingenix estimated that 2004 ASC reimbursement under current commission rules (requiring fair and reasonable reimbursement) equals approximately 320% of 2004 Medicare reimbursement. Additionally, this review estimated commercial (HMO/PPO/POS/Indemnity) payer reimbursement equal to a range of 168% to 564%. This commercial range produces a weighted average of approximately 274% (not including indemnity plans) to 293% (including indemnity plans) of Medicare reimbursement. With Medicare added to the commercial market, the weighted average for ASC services trended to 2004 is 237% (not including indemnity plans) to 264% (including indemnity plans) of Medicare reimbursement. This identified range (237% - 264%) is extended in the Ingenix report to 213.3% - 290.4% to recognize the potential for the commission to place special emphasis on the requirements of the Act. The adopted rate is well within the range of commercial reimbursements at which ASCs provide services.

The Ingenix analysis thoroughly analyzed Medicare reimbursement and commercial reimbursement for ambulatory surgery center services. This included both the reimbursement rates and market share by payer type for persons with a similar standard of living, and allowed Ingenix to provide the commission with a recommended acceptable range of PAFs. This Ingenix recommendation reflects the weighted average reimbursement for individuals with a similar standard of living. The commission carefully considered the Ingenix analysis and recommendation and the requirements of the Act in adopting the PAF, which is well within the range of reimbursements accepted by ambulatory surgery centers in the commercial market and within the "fair and reasonable" reimbursements currently accepted by ASCs participating in the Texas workers' compensation system. Further, the commission clarifies that the methodology Ingenix used (as fully described in the April 2004 adoption preamble of §134.402) to develop its recommendation stands alone and is not dependent on the methodologies used in previous reimbursement guidelines proposed or adopted by the commission. The Medicare rate is the reference point from which the reimbursement rate is built, but is neither a ceiling nor a floor. Development of the PAF is a balance of all the components of the Act. Ingenix concluded that, if there are additional administrative burdens for facilities, they are more than offset and accounted for in the rates within the Ingenix range.

The commission clarifies that Ingenix removed indemnity reimbursement, which was extraordinarily high as compared to commercial reimbursement generally, from the calculation. Removing this potential aberration resulted in a decrease at the lower end of the PAF. The commission clarifies that the adopted PAF falls within the acceptable range of reimbursements recommended by Ingenix. Additionally, Ingenix suggested that the commission could use its discretion to consider a different balance of the statutory objectives -- for instance, by placing greater emphasis on cost containment or increased security of payment within the Texas workers' compensation system -- and deviate up to 10% at either end of the recommended range. In response to the high medical costs per claim in Texas and the desire by the Legislature and the commission to reverse the cost per claim trends, the commission adopted an appropriate PAF. The commission agrees that it is appropriate to review other states' ASC reimbursement methodologies; however, due to each state's unique system requirements, those methodologies are not determinative of reimbursement in Texas. Analysis of Medicare reimbursement methodologies in other states showed PAFs to be within a range from at or near the Medicare rate to over 250% of the Medicare rate. Commission staff surveyed several other states that use the Medicare ASC reimbursement methodology. The reimbursement in those states as a percentage of Medicare ranged from 100% to 255%. The adopted PAF is well within this range of other states' reimbursement for ASC's.

The commission disagrees that commercial indemnity was not included as part of the recommendation, or on the other hand that commercial indemnity was the only type considered; on the contrary, it was included in one portion of the recommended range which yielded the 264% PAF. When indemnity reimbursement is excluded from the weighted market calculation, the lower limit of the Ingenix recommendation becomes 237% of Medicare. The indemnity market share currently represents a small, decreasing fraction of the overall market, with payment levels far exceeding those in other commercial policy types, suggesting that they are uncharacteristic of the commercial market. In order to provide the most comprehensive range of fair and reasonable reimbursement rates, and address the statutory requirement for cost control and prohibition against paying higher than would be paid by or for persons with similar standards of living, Ingenix recommended, and the commission agreed, that it was appropriate to exclude the indemnity experience at the lower end of the range and include it at the higher end of the range. In all scenarios, Medicare reimbursement and market share were included in the weighted average to establish a range.

The commission agrees that health care costs throughout all sections of the health care system are rising, and that some employers are re-visiting options relating to employee contributions to group health plans.

COMMENT: Commenters recommended varying increases in the PAF of the Medicare fee schedule for additional reasons, including: (1) Medicare's ASC rates will remain frozen until 2009. (2) Cases have been turned away from ASCs since this rule implementation causing a 42% difference that is annualized over the year, which will cost the workers' compensation system over $500,000 in additional costs. This figure represents a 60% reduced ASC reimbursement, and not the 30% the commission estimated. (3) Other states have found 100% of Medicare as a reasonable reimbursement rate. A commenter additionally stated that consultants have found, based on Florida's Agency for Health Care Administration (AHCA) discharge data, that there is no material difference in the total number of ASCs performing each procedure and the number of ASCs performing each procedure on Medicare patients indicating any lack of access for Medicare patients.

RESPONSE: The commission disagrees that future changes in the Medicare ASC reimbursement system should prevent the commission from adopting the most current Medicare ASC reimbursement system as required by the Act. Because the commission is also required to meet other provisions of the Act regarding fair and reasonable reimbursement during its required reviews of guidelines, regardless of any current or potential future changes in Medicare reimbursement, the commenters' reference to the future potential Medicare revisions is irrelevant. The commission disagrees that the overall difference in reimbursement is 42% and this change has added over $500,000 in costs to the system, since the commission has not been provided information to document or support the commenters' assertions. Anecdotally, carriers generally make the opposite assertion that similar services are being provided at a lower reimbursement in the hospital outpatient setting than the ASC setting in many instances. The commission disagrees that other states reimbursement at 100% of Medicare is an indicator of the appropriate reimbursement rate for the Texas workers' compensation system. The commission has surveyed several states and found a wide range of ASC reimbursement rates from 100% of Medicare to over 250% of Medicare, each with unique statutory requirements. The rate adopted by the commission reflects the requirements of the Act and is appropriate for use in the Texas workers' compensation system.

COMMENT: Commenter recommended a rate of 250% of Medicare is necessary for cases to remain as they were done in an ASC rather than the surgery department in a hospital.

RESPONSE: The commission disagrees with commenters' recommendation, as the PAF itself was not a proposed amendment to this rule. Nevertheless, the commission addressed this concern in the adoption preamble of April 2004 (28 TexReg 4191) and the adopted PAF is the result of careful analysis by Ingenix and consideration by the commission.

COMMENT: Commenter opined that the new system of payment for ASCs that Congress directed CMS to consider is based on Medicare APC fee schedule, and commenter recommends the commission use this new system.

RESPONSE: The commission clarifies that the Act requires "... the commission shall adopt the most current reimbursement methodologies, models, and values or weights used by the federal Health Care Financing Administration, including applicable payment policies related to coding, billing, and reporting, ..." The commission has adopted the most current Medicare ASC reimbursement methodology. If and when, Medicare implements a revised ASC reimbursement methodology, the commission would move to implement that methodology to maintain standardization as required by the Act.

COMMENT: Commenter stated that Ingenix did not compare its recommended conversion factors with conversion factors in other states because each state approached its reimbursement methodology differently. This statement is inconsistent with the Workers' Compensation Research Institute (WCRI) analysis and the commission's handling of the same issue in the 2002 MFG.

RESPONSE: The commission clarifies that there is no WCRI ASC reimbursement analysis. The Ingenix report and commission research found a wide range of reimbursement rates for ASC services provided in other states' workers' compensation systems as previously noted elsewhere in this preamble.

COMMENT: Commenter advised that changes to Medicare fees, as a result of recent federal legislation (e.g., Medicare Prescription Drug Bill, The Secretary of Health and Human Services' revised payment schedule), will require the commission to again re-examine ASC fees in the near future.

RESPONSE: The commission agrees as it is required to review guidelines bi-annually and will continue to proactively monitor changes as evidenced by this rule revision.

COMMENT: Commenter states the problem is that since SB-1 in 1989, ASCs have never been regulated by the workers' compensation system. As time went on, more care was shifted to the ASC setting, more ASCs were established, and physicians found them a good way to supplement their income. As a result of ASCs not being regulated, the ASCs profited. The insurance industry is at fault for paying ASC bills with very little scrutiny, until over time they had to change this practice and the commission in not passing a rule years ago to avoid what we are facing today.

RESPONSE: The commission acknowledges commenter's historical perspective in the development of ASC fee guidelines, but does not see anything here that warrants a change to those amendments. These changes are necessary and appropriate, given information provided to the commission and the balance of statutory mandates that apply.

The amendment is adopted under Texas Labor Code §402.061, which authorizes the commission to adopt rules necessary to administer the Act; Texas Labor Code §408.021, which entitles injured employees to all health care reasonably required by the nature of the injury as and when needed; Texas Labor Code §413.002, which requires the commission's Medical Review Division monitor health care providers, insurance carriers and claimants to ensure compliance with commission rules; Texas Labor Code §413.007, which sets out information to be maintained by the commission's Medical Review Division; Texas Labor Code §413.011, which mandates that the commission by rule establish medical policies and guidelines; Texas Labor Code §413.012, which requires review and revision of the medical policies and fee guidelines at least every two years; Texas Labor Code §413.013, which requires the commission by rule to establish programs related to health care treatments and services for dispute resolution, monitoring, and review; Texas Labor Code §413.014, which requires express preauthorization by the insurance carrier for health care treatments and services; Texas Labor Code §413.015, which requires insurance carriers to pay charges for medical services as provided in the statute and requires that the commission ensure compliance with the medical policies and fee guidelines through audit and review; Texas Labor Code §413.016, which provides for refund of payments made in violation of the medical policies and fee guidelines; Texas Labor Code §413.017, which provides a presumption of reasonableness for medical services fees that are consistent with the medical policies and fee guidelines; Texas Labor Code, §413.019, which provides for payment of interest on delayed payments refunds or overpayments; and Texas Labor Code §413.031, which provides a procedure for medical dispute resolution.

The amendment is adopted under the Texas Labor Code §§402.061, 408.021, 413.002, 413.007, 413.011, 413.012, 413.013, 413.014, 413.015, 413.016, 413.017, 413.019, and 413.031.

The previously cited sections of the Texas Labor Code are affected by this rule action. No other code, statute, or article is affected by this rule action.

§134.402.Ambulatory Surgical Center Fee Guideline.

(a) Applicability of this rule is as follows:

(1) This section applies to facility services provided by an ambulatory surgical center (ASC), other than professional medical services.

(2) This section applies to facility services provided by an ASC on or after September 1, 2004. The provisions of subsection (e)(2), (3), and (4), and subsection (f) of this section apply to facility services provided by an ASC on or after April 1, 2005.

(3) Specific provisions contained in the Texas Workers' Compensation Act (Act) or Texas Workers' Compensation Commission (commission) rules, including this rule, shall take precedence over any conflicting provision adopted or utilized by the Centers for Medicare and Medicaid Services (CMS) in administering the Medicare program. Exceptions to Medicare payment policies for medical necessity may be provided by commission rule. Independent Review Organization (IRO) decisions regarding medical necessity are made on a case-by-case basis. The commission will monitor IRO decisions to determine whether commission rulemaking action would be appropriate.

(4) Whenever a component of the Medicare program is revised and effective, use of the revised component shall be required for compliance with commission rules, decisions and orders for services rendered on or after the effective date of the revised component.

(b) For coding, billing, reporting, and reimbursement of facility services covered in this rule, Texas workers' compensation system participants shall apply the Medicare program reimbursement methodologies, models, and values or weights including its coding, billing, and reporting payment policies in effect on the date a service is provided with any additions or exceptions in this section.

(c) To determine the maximum allowable reimbursement (MAR) for a particular service, system participants shall apply the Medicare payment policies for these services and the Medicare ASC reimbursement amount multiplied by 213.3%.

(d) In all cases, reimbursement shall be the lesser of the:

(1) MAR amount regardless of billed amount; or

(2) facility's and payer's workers' compensation negotiated and/or contracted amount that applies to the billed service(s).

(e) Exceptions and modifications to the Medicare payment policies are as follows:

(1) Whenever Medicare requires a payment policy change to be retroactive, that change shall only apply to services provided on or after the date of that change.

(2) In addition to the ASC List of Medicare Approved Procedures, the following procedures will be reimbursed when provided in an ASC at the reimbursement rate provided by this section as if they were on that list (using the same Medicare group assignment values):

(A) 11750 - Group 1

(B) 11760 - Group 1

(C) 20552 - Group 1

(D) 20526 - Group 1

(E) 27599 - Group 1

(F) 29873 - Group 3

(G) 29999 - Group 4

(H) 63030 - Group 6

(I) 64405 - Group 1

(J) 64999 - Group 1

(3) If a service is not included on the ASC List of Medicare Approved Procedures or listed in subsection (e)(2) of this section, the insurance carrier (carrier), health care provider, and ASC may agree to an ASC setting as follows:

(A) The agreement may occur before, during, or after preauthorization.

(i) A preauthorization request may be submitted for an ASC setting only if an agreement has already been reached and a copy of the signed agreement is filed as a part of the preauthorization request.

(ii) A preauthorization request or approval for a non-ASC facility setting may be revised to an ASC setting by written agreement of the carrier and the health care provider during or after preauthorization.

(B) The agreement between the carrier and the ASC must be in writing, in clearly stated terms, and include:

(i) the reimbursement amount;

(ii) any other provisions of the agreement; and

(iii) names, titles and signatures of both parties with dates.

(C) Copies of the agreement are to be kept by both parties.

(D) Upon request of the Commission, the agreement information shall be submitted in the form and manner prescribed by the Commission.

(4) The carrier shall reimburse all surgically implanted, inserted, or otherwise applied devices at the lesser of the manufacturer's invoice amount or the net amount (exclusive of rebates and discounts) actually paid for such device to the manufacturer by the ASC. Provider billing shall include a certification that the amount sought represents its actual cost (net amount, exclusive of rebates and discounts). That certification shall include the following sentence: "I hereby certify under penalty of law that the following is the true and correct actual cost to the best of my knowledge."

(f) A carrier may use the audit process under §133.302 and §133.303 of this title (relating to Preparation for an Onsite Audit and Onsite Audits) to seek verification that the amount certified under subsection (e)(4) of this section properly reflects the actual cost standard contained in that subsection. Such verification may also take place in the Medical Dispute Resolution process under §133.307 of this title (relating to Medical Dispute Resolution of a Medical Fee Dispute), if that process is properly requested.

(g) Where any terms or parts of this section or its application to any person or circumstance are determined by a court of competent jurisdiction to be invalid, the invalidity does not affect other provisions or applications of this section that can be given effect without the invalidated provision or application.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 18, 2005.

TRD-200500769

Susan Cory

General Counsel

Texas Workers' Compensation Commission

Effective date: March 10, 2005

Proposal publication date: December 3, 2004

For further information, please call: (512) 804-4287