DOD Issues Rule on Mental Health, Substance Use Disorder Treatment
TRICARE; Mental Health and Substance Use Disorder Treatment
A Rule by the
Publication Date:
Agencies:
Dates: This rule is effective
Effective Date:
Entry Type: Rule
Action: Final rule.
Document Citation: 81 FR 61067
Page: 61067 -61098 (32 pages)
CFR: 32 CFR 199
Agency/Docket Number:
RIN: 0720-AB65
Document Number: 2016-21125
Shorter URL: https://federalregister.gov/a/2016-21125
ACTION
Final Rule.
SUMMARY
This final rule modifies the TRICARE regulation to reduce administrative barriers to access to mental health benefit coverage and to improve access to substance use disorder (SUD) treatment for TRICARE beneficiaries, consistent with earlier
DATES:
This rule is effective
FOR FURTHER INFORMATION CONTACT:
Dr.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of the Final Rule
1. The Need for the Regulatory Action
This final rule updates TRICARE mental health and substance use disorder benefits, consistent with earlier
This rule has four main objectives: (a) To eliminate unnecessary quantitative and non-quantitative treatment limitations on SUD and mental health benefit coverage and align beneficiary cost-sharing for mental health and SUD benefits with those applicable to medical/surgical benefits; (b) to expand covered mental health and SUD treatment under TRICARE, to include coverage of intensive outpatient programs and treatment of opioid use disorder; (c) to streamline the requirements for mental health and SUD institutional providers to become TRICARE authorized providers; and (d) to develop TRICARE reimbursement methodologies for newly recognized mental health and SUD intensive outpatient programs and opioid treatment programs.
(a) Eliminating Unnecessary Quantitative and Non-Quantitative Treatment Limitations on SUD and Mental Health Benefit Coverage and Aligning Beneficiary Cost-Sharing for Mental Health and SUD Benefits With Those Applicable to Medical/Surgical Benefits
The requirements of the Mental Health Parity Act (MHPA) of 1996 and the
Section 703 of the National Defense Authorization Act (NDAA) National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2015, signed into law
In addition to the elimination of these statutory inpatient day limits and corresponding waiver provisions, the rule will also eliminate other unnecessary quantitative and non-quantitative treatment limitations, consistent with principles of mental health parity and our governing laws.
Additionally, this rulemaking will remove the categorical exclusion on treatment of gender dysphoria. This change will permit coverage of all non-surgical medically necessary and appropriate care in the treatment of gender dysphoria, consistent with the program requirements applicable for treatment of all mental or physical illnesses. Surgical care remains prohibited by statute at 10 U.S.C. 1079(a)(11), as discussed further below.
Finally, following the recent repeal (section 703 of the NDAA for FY 15) of the statutory authority (previously codified at 10 U.S.C. 1079(i)(2)) for separate beneficiary financial liability for mental health benefits, the rule revises the cost-sharing requirements for mental health and SUD benefits to be consistent with those that are applicable to TRICARE medical and surgical benefits.
(b)
Previously, TRICARE benefits did not fully reflect the full range of contemporary SUD treatment approaches (i.e., outpatient counseling and intensive outpatient program (IOP)) that are now endorsed by the
An amendment to the regulation was necessary to authorize TRICARE benefit coverage of medically and psychologically necessary services and supplies which represent appropriate medical care and that are generally accepted by qualified professionals to be reasonable and adequate for the diagnosis and treatment of mental disorders. TRICARE coverage of medication assisted treatment (MAT) for opioid use disorder, extended through regulatory revisions, as published in the
(c) Streamlining Requirements for
While TRICARE's comprehensive certification standards were once considered necessary to ensure quality and safety, these comprehensive certification requirements proved to be overly restrictive and at times inconsistent with current industry-based institutional provider standards and organization. There are currently several geographic areas that are inadequately served because providers in those regions did not meet TRICARE certification requirements, though they may have met the industry standard. This final rule will streamline TRICARE regulations to be consistent with industry standards for authorization of qualified institutional providers of mental health and SUD treatment. It is anticipated that these revisions will result in an increase in the number and geographic coverage areas of participating institutional providers of mental health and SUD treatment for TRICARE beneficiaries.
(d) TRICARE Reimbursement Methodologies for
Along with recognition of several new categories of TRICARE authorized providers, this rule establishes reimbursement methodologies for these providers. Specifically, new reimbursement methodologies are instituted for IOPs for mental health and SUD treatment as well as OTPs, as these providers had not previously been recognized by TRICARE and thus appropriate reimbursement methodologies must be established. Existing reimbursement methodologies for SUDRFs, RTCs, and PHPs will continue to apply.
2.
The legal authority for this final rule is 10 U.S.C., section 1073, which authorizes the Secretary of Defense to make decisions concerning TRICARE and to administer the medical and dental benefits provided in title 10 U.S.C., chapter 55. The Department is authorized to provide medically necessary and appropriate medical care for mental and physical illnesses, injuries and bodily malfunctions, including hospitalization, outpatient care, drugs, and treatment of mental health conditions under 10 U.S.C. 1077(a)(1) through (3) and (5). Although section 1077 identifies the types of health care to be provided in military treatment facilities (MTFs) to those authorized such care under section 1076, these same types of health care (with certain specified exceptions) are authorized for coverage within the civilian health care sector for ADFMs under section 1079 and for retirees and their dependents under section 1086. In general, the scope of TRICARE benefits covered within the civilian health care sector and the TRICARE authorized providers of those benefits are found at 32 CFR 199.4 and 199.6, respectively.
TRICARE beneficiary cost-sharing is governed by statute and regulation based upon both the beneficiary category and TRICARE option being utilized. With the recent repeal of the statutory authority (previously codified at 10 U.S.C. 1079(i)(2)) for separate beneficiary financial liability for mental health benefits, this final rule revises the cost-sharing requirements for mental health and SUD benefits to be consistent with those that are applicable to TRICARE medical and surgical benefits.
With respect to institutional provider reimbursement, pursuant to 10 U.S.C. 1079(i)(2), the Secretary is required to publish regulations establishing the amount to be paid to any provider of services, including hospitals, comprehensive outpatient rehabilitation facilities, and any other institutional facility providing services for which payment may be made. The amount of such payments shall be determined, to the extent practicable, in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under
B. Summary of the Major Provisions of the Final Rule
1. Eliminating Unnecessary Quantitative and Non-Quantitative Treatment Limitations on SUD and Mental Health Benefit Coverage and Aligning Beneficiary Cost-Sharing for Mental Health and SUD Benefits With Those Applicable to Medical/Surgical Benefits
This final rule makes a number of comprehensive revisions to the TRICARE mental health and SUD treatment coverage. In an effort to further de-stigmatize SUD care, treatment of SUDs is no longer separately identified as a limited special benefit under 32 CFR 199.4(e) but rather has now been incorporated into the general mental health provisions in section 199.4(b) governing institutional benefits and section 199.4(c) governing professional service benefits. Further, this rule eliminates a number of mental health and SUD quantitative and non-quantitative treatment limitations, and corresponding waiver provisions, instead relying on determinations of medical necessity and appropriate utilization management tools, as are used for all other medical and surgical benefits. Proposed revisions include eliminating:
All inpatient mental health day limits, following the statutory revisions to 10 U.S.C. 1079;
The 60-day partial hospitalization and SUDRF residential treatment limitations;
Annual and lifetime limitations on SUD treatment;
Presumptive limitations on outpatient services including the six-hours per year limit on psychological testing; the limit of two sessions per week for outpatient therapy; and limits for family therapy (15 visits) and outpatient therapy (60 visits) provided in free-standing or hospital based SUDRFs;
The limit of two smoking cessation quit attempts in a consecutive 12 month period and 18 face-to-face counseling sessions per attempt; and
The regulatory prohibition that categorically excludes all treatment of gender dysphoria.
The rule also changes cost-sharing for mental health treatment for TRICARE Prime and Standard/Extra beneficiaries to align with the applicable cost-sharing provisions for other non-mental health inpatient and outpatient benefits. Additionally, revisions clearly identify services that will be cost-shared on an inpatient (e.g., inpatient admissions to a hospital, residential treatment center, SUDRF residential treatment program, or skilled nursing facility) versus outpatient (including partial hospitalization programs, intensive outpatient treatment services, and opioid treatment program services) cost-sharing basis to ensure consistency with the statutory requirements in 10 U.S.C. 1079 and 1086. In many cases, these modifications to cost-sharing will enhance TRICARE beneficiary access to care through lower out-of-pocket costs.
2. Expanding Coverage To Include Mental Health and SUD Intensive Outpatient Programs and Treatment of Opioid Use Disorder
The regulatory language defines and authorizes new services by TRICARE authorized institutional and individual providers of SUD care outside of SUDRF settings at section 199.2 and 199.6. Revisions to treatment benefits at section 199.4 and section 199.6 will allow intensive outpatient programs (IOPs) for mental health and SUD treatment; care in opioid treatment programs (OTPs); and outpatient SUD treatment (i.e., office-based opioid treatment, psychosocial treatment and family therapy) by individual TRICARE authorized providers.
3. Streamlining Requirements for
Significant revisions to 32 CFR 199.6 eliminate the administratively burdensome provider certification process and streamline approval for institutional mental health and SUD providers to become TRICARE authorized providers. In multiple regions providers may meet industry standards but do not meet TRICARE certification requirements. Consequently, providers in these regions were unable to serve TRICARE beneficiaries. The applicable provisions for residential treatment centers, psychiatric and SUD partial hospitalization programs, and SUDRFs, have been rewritten in their entirety to address institutional provider eligibility, organization and administration, participation agreement requirements and any other requirements for approval as a TRICARE authorized provider. The requirement and formal process of certification will be eliminated. Similarly, new regulatory provisions for the newly recognized categories of institutional providers, namely IOPs and OTPs are instituted.
4. TRICARE Reimbursement Methodologies for
Finally, amendments to 32 CFR 199.14, which specifies provider reimbursement methods, establish allowable all-inclusive per diem payment rates for psychiatric and SUD, PHP, IOP and OTP services.
C. Costs and Benefits
The amendment is not anticipated to have an annual effect on the economy of
Elimination of the statutory day limits for inpatient psychiatric and
Creating additional levels, providers, and types of mental health care (e.g., intensive outpatient programs, opioid treatment programs, non-surgical coverage for gender dysphoria, and also allowing outpatient substance use treatment) will increase costs to the program by approximately
Additionally, TRICARE currently has an estimated 15,000 to 20,000 beneficiaries with opioid use disorder who, under the previous benefit, could not access medication-assisted treatment (MAT; e.g., buprenorphine or methadone). According to SAMHSA, there are approximately 1400 OTPs in
Streamlining requirements for institutional providers to become TRICARE authorized providers of mental health and SUD care will incur an estimated increased cost of
D. Public Comments
On
II. Provisions of the Rule Regarding Eliminating Unnecessary Quantitative and Non-Quantitative Treatment Limitations on SUD and Mental Health Benefit Coverage and Aligning Beneficiary Cost-Sharing for Mental Health and SUD Benefits With Those Applicable to Medical/Surgical Benefits
A. Eliminating Unnecessary Quantitative and Non-Quantitative Treatment Limitations on SUD and Mental Health Benefit Coverage
1. Provisions of the Proposed Rule. This final rule will remove a number of unnecessary quantitative and non-quantitative limits for coverage of mental health and SUD care under the TRICARE Program, including:
All inpatient mental health day (30 days maximum for adults and 45 days maximum for children at 32 CFR 199.4(b)(9)) and annual day limits (150 days at 32 CFR 199.4(b)(8)) for RTC care for beneficiaries 21 years and younger, following the statutory revisions to 10 U.S.C. 1079;
The 60-day limitation on partial hospitalization (32 CFR 199.4(b)(10)(iv)) and SUDRF residential treatment (32 CFR 199.4(e)(4)(ii)(A));
Annual (60 days in a benefit period) and lifetime (three treatment episodes--32 CFR 199.4(e)(4)(ii)) limitations on SUD treatment;
Presumptive limitations on outpatient services including the six-hour per year limit on psychological testing (32 CFR 199.4(c)(3)(ix)(A)(5)) and the limit of two sessions per week for outpatient therapy (32 CFR 199.4(c)(3)(ix)(B));
Limits on family therapy (15 visits (32 CFR 199.4(e)(4)(ii)(C)) and outpatient therapy (60 visits--(32 CFR 199.4(e)(4)(ii)(B)) provided in free-standing or hospital based SUDRFs; and
The limit of two smoking cessation quit attempts in a consecutive 12 month period and 18 face-to-face counseling sessions per attempt (32 CFR 199.4(e)(30)).
This rule will also allow coverage of outpatient treatment that is medically or psychologically necessary, including psychotherapy, family therapy and other covered diagnostic and therapeutic services, by a TRICARE authorized institutional provider or by authorized individual mental health providers without limits on the number of treatment sessions. All claims submitted for services under TRICARE remain subject to review for quality and appropriate utilization in accordance with the Quality and Utilization Review Peer Review Organization Program, under 10 U.S.C. 1079(n) and 32 CFR 199.15.
The rule also removes certain regulatory exclusions for the treatment of gender dysphoria for TRICARE beneficiaries who are diagnosed by a TRICARE authorized provider, practicing within the scope of his or her license, to be suffering from a mental disorder, as defined in 32 CFR. 199.2. It is no longer justifiable to categorically exclude and not cover currently accepted medically and psychologically necessary treatments for gender dysphoria (such as psychotherapy, pharmacotherapy, and hormone replacement therapy) that are not otherwise excluded by statute. (Section 1079(a)(11) of title 10, U.S.C., excludes from CHAMPUS coverage surgery which improves physical appearance but is not expected to significantly restore functions, including mammary augmentation, face lifts, and sex gender changes.)
2. Analysis of Major Public Comments. Many commenters expressed strong support for the removal of presumptive quantitative limitations on mental health treatment benefits, such as elimination of inpatient mental health day limits, the previous six hours per year limit on psychological testing, the limit of two sessions per week for outpatient therapy, and the limit of two smoking cessation quit attempts in a consecutive 12 month period. One commenter specifically suggested a raised limit on the number of smoking cessation quit attempts in a consecutive 12 month period. There was also one specific expression of support for the inclusion of music therapy as an ancillary therapy. One commenter noted that individuals with substance use disorders should be allowed only one treatment episode, and subsequent to this, benefit coverage for SUD treatment should be suspended.
Response: We appreciate the overwhelming support for these proposed changes which will reduce unnecessary administrative barriers and ensure ready access to medically necessary care for our beneficiaries. In response to the general concerns regarding cost and necessity for the proposed changes we would emphasize that while specific, presumptive quantitative treatment limitations have been eliminated, mental health and SUD care will still be reviewed for continued medical necessity and subject to utilization management review, as is all care under the TRICARE program. We believe this approach provides an appropriate balance between reducing administrative barriers to care while still ensuring appropriate utilization. Regarding allowance of only one treatment episode for SUD care, this is far less than the Department's previous allowance of three episodes of treatment for SUD care. The removal of these limitations recognizes that SUDs are chronic conditions with periodic phases of relapse and readmission, often requiring multiple interventions over several years to achieve full remission. With respect to the suggestion to raise the limit on smoking cessation quit attempts, the Department's approach of eliminating all presumptive quantitative limitations makes such a recommendation unnecessary. Finally, with respect to music therapy, we would note that while it is not recognized as a primary mental health or SUD treatment modality, it remains a covered ancillary therapy benefit solely when provided in the context of an approved inpatient, SUDRF, residential treatment, partial hospitalization, or intensive outpatient program treatment plan and under the clinical supervision of a qualified mental health professional.
Comment: Multiple national organizations sent comments requesting a definition of the term "qualitative" treatment limits as used in the proposed rule to be consistent with the MHPAEA, citing that the MHPAEA uses only the terms "quantitative" and "non-quantitative" treatment limits. While applauding TRICARE's removal of quantitative treatment limits (QTLs), some argued that the rule should go farther to achieve parity in accordance with the MHPAEA, and cited sections of regulation they perceived as non-quantitative treatment limitations (NQTLs) that are inconsistent with the MHPAEA, such as those: Requiring utilization review, quality assurance and reauthorization for inpatient mental health services and partial hospitalization at 199.4(a)(11) and (12); outlining medical necessity criteria for institutional providers of mental health treatment at 199.4(b); and, providing descriptions and requirements for mental health providers at 199.6(b) that were perceived as more detailed than those for medical/surgical settings. Several commenters also suggested that since compliance with the letter and the spirit of mental health parity rules has been inconsistent, that TRICARE issue clear guidance regarding enforcement of its requirements as well as establish a systemized way of collecting information from medical providers and enrollees about compliance. Several other commenters specifically requested that the final rule explicitly require issuers and plans to perform a compliance review of the plan or issuer's financial requirements regarding QTLs and NQTLs applied by the plan or issuer; and require plans and issuers to provide documentation that illustrates how the health plan has determined the financial requirements, QTLs and/or NQTLs are in compliance. Finally, one commenter noted that while they understood that TRICARE was not subject to the MHPAEA statute, they were not aware of any statutory prohibition which would preclude a complete modeling of its MH/SUD benefits with MHPAEA's qualitative, or NQTL, treatment limitation requirements.
Response: The Department appreciates the comments regarding "qualitative" or "non-quantitative" treatment limitations (NQTLs) and apologizes for any confusion created in the proposed rule by not following the same terminology used in the MHPAEA. In this final rule, the term "non-quantitative" has been substituted for "qualitative" for clarity and consistency.
The Department believes that it is important to note that TRICARE is a program of medical benefits provided by the
We would also like to respond to the specific comments and recommendations we received that suggested additional revisions to existing TRICARE regulatory provisions could be made to achieve greater alignment and parity with medical/surgical benefits. First, one commenter suggested that the preauthorization, utilization review and quality assurance requirements for mental health care at section 199.4(a)(11) and (12) constitute NQTLs and should be eliminated. The Department emphasizes that all health care services for which reimbursement is sought under TRICARE are subject to review for quality of care and appropriateness of utilization as required by statute, 10 U.S.C. 1079(n). TRICARE's Quality and Utilization Review Peer Review Organization Program at 32 CFR 199.15 prescribes the objectives, requirements and procedures for how TRICARE addresses quality assurance, reauthorization and other utilization review practices for all health care services, including medical and surgical care. With that said, the Department is committed to removing unnecessary quantitative and non-quantitative treatment limitations and simplifying our regulations where it makes sense. In re-reviewing the existing regulatory language in section 199.4(a)(11) and (12), we agree that the language is unnecessary and should be eliminated. With the remaining regulatory provisions that are applicable to all covered services, including both medical/surgical as well as mental health/SUD, there is no need to separately address quality and utilization review of mental health services. Therefore, within section 199.4, the parenthetical reference to utilization and quality review of mental health services in paragraph (a)(11) has been removed. Additionally, paragraph (a)(12) regarding utilization and quality review specifically for inpatient mental health and partial hospitalization has been removed and the paragraph reserved.
Additionally, the same commenter raised concerns that specific medical necessity criteria were included within the regulatory language under section 199.4 for mental health and SUD services while similar medical necessity criteria were not specified for medical/surgical services and settings. While the Department appreciates the comment, we have elected to retain this regulatory language as having these medical necessity criteria in regulation is instructive and informative for all stakeholders in administering the TRICARE benefit. Further, we do not believe these criteria are discriminatory or unnecessary but rather are reflective of the overarching statutory requirement that care be medically necessary and appropriate. These terms ("medically or psychologically necessary" and "appropriate medical care") are further defined in regulation at section 199.2. These same requirements apply to TRICARE medical and surgical benefits. The language where included in section 199.4 is specifically tailored to address medically necessity in that context, particularly with respect to the different levels of care that are available for the treatment of mental health and SUD that do not have a corresponding medical or surgical counterpart. The Department has also sought to strike an appropriate balance between eliminating unnecessary language and regulatory provisions while at the same time ensuring transparency in program administration.
Regarding comments that the Department set forth more elaborate descriptions and requirements for mental health institutional providers than for medical/surgical settings, a major objective of this rule has been to achieve significant streamlining of the descriptions and requirements for TRICARE authorization of institutional mental health care providers under sections 199.6(b)(4)(vii) (RTCs), 199.6(b)(4)(xii) (PHPs), and 199.6(b)(4)(xiv) (SUDRFs) and we believe we have achieved that objective. The proposed revisions which are finalized in this rule have eliminated a large portion of the existing descriptions and requirements for existing mental health/SUD institutional providers. For each type of provider, the amended regulation includes a definition/general description of the type of institutional provider and eligibility requirements including licensing, accreditation, a written participation agreement and adherence to general TRICARE requirements. We have eliminated the elaborate descriptions that are contained in the existing regulations regarding such things as the organization of the facility and specific qualifications of the governing body (including the facility's Chief Executive Officer, Clinical Director, Medical Director and Medical or professional staff organization), staff composition, staff qualifications, admission process, assessments, treatment planning, discharge and transition planning, standards for physical plant and environment and a variety of other requirements that we believe are more appropriately satisfied through a national accreditation process. Similarly, we have also eliminated the requirements regarding capacity (30 percent) and length of time licensed and at full operational status (6 months) for OTPs, RTCs, PHPs, IOPs, and SUDRFs.
Furthermore, we would note the general requirement in section 199.6(a)(8)(i) that all institutional providers must be participating providers under TRICARE. Hospitals (whether providing medical/surgical and/or mental health/SUD care) that are certified and participating under
With respect to comments about specific requirements for inclusion in participation agreements, all institutional providers are required, under section 199.6(8)(i)(A), to be a participating provider under TRICARE, and the general provisions that must be included in the agreement are outlined in regulation at section 199.6(a)(13) and are equally applicable to medical/surgical and mental health/SUD institutional providers. In general, we believe the specific requirements outlined in section 199.6(b) are reflective of the general participation agreement requirements and simply tailored to the particular type of provider (so for instance, when requiring that the participating provider agree to accept the determined allowable amount, the regulatory provisions cross reference to the applicable reimbursement methodology for that type of provider). Again, we have sought to balance the competing interests of streamlining our regulations to the extent practicable with ease of reference for the reader, coupled with our commitment to ensuring transparency in program requirements. Further, these participation agreements ensure providers accept assignment on TRICARE claims, thereby protecting our beneficiaries from financial liability above their applicable deductibles and cost-shares, and ensure compliance with applicable program requirements in support of the provision of safe, quality care to our beneficiaries.
Additionally, while we wanted to address the general mental health parity comments here, several of the specific requirements for mental health and SUD institutional providers contained in section 199.6 and referenced in public comments are more appropriately addressed below in the following sections.
Comment: Nineteen respondents expressed strong objection to the addition of benefit coverage for the diagnosis of gender dysphoria citing cost concerns and an inappropriate use of taxpayer funds. Several commenters expressed concerns about impact on military units and military readiness resulting from the treatment of transgender Service Members. Sixteen respondents commented in support of the proposed rule's addition of benefit coverage for psychological and medical care for gender dysphoria. Four respondents expressed objection to surgical coverage of gender dysphoria under the proposed rule. Two commenters expressed objection based on the conscience rights and first amendment liberties of those who work in the healthcare field and urged the retention of the regulatory exclusion as the diagnosis and treatment of gender dysphoria remains medically controversial. Conversely, several national organizations cited support for the addition of benefit coverage for the diagnosis of gender dysphoria but expressed significant objection to the exclusion of surgical treatment for gender dysphoria.
Response: The Department proposed to remove the exclusion on non-surgical treatment of gender dysphoria as it is no longer justifiable to categorically exclude and not cover current medical and psychologically necessary and appropriate proven treatments that are not otherwise excluded by law. Section 1557 of the Affordable Care Act prohibits discrimination on the basis of race, origin, sex, disability, or age (consistent with the scope of Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975). HHS recently released a final rule implementing Section 1557. That rule prohibits discrimination based on gender identity (incident to the Title IX ban on sex discrimination) in health programs. The rule by its terms applies only to HHS programs, but the statute applies to all federal health programs, and
Surgical coverage of gender dysphoria was not included in the proposed rule, is not included in this final rule, and remains prohibited by statute at 10 U.S.C. 1079(a)(11). Several commenters argued the rule did not go far enough and others suggested the Department reconsider including coverage for transgender surgeries. Several argued the statutory exclusion was otherwise not applicable or ambiguous, must be interpreted in accordance with modern medical science and contemporary standards of care, and thus should not be read to exclude medically necessary surgical care to treat gender dysphoria. The pertinent statutory provision (10 U.S.C. 1079(a)(11)) states: "Surgery which improves physical appearance but is not expected to significantly restore functions (including mammary augmentation, face lifts, and sex gender changes) may not be provided. . . ." The statute lists three exceptions--breast reconstructive surgery following a mastectomy, reconstructive surgery to correct serious deformities caused by congenital anomalies or accidental injuries, and neoplastic surgery. Some commenters believed that
3. Provisions of the Final Rule. The final rule is consistent with the proposed rule except that sections making specific reference to mental health inpatient and partial hospitalization utilization review, quality assurance, and reauthorization requirements have been removed at section 199.4(a)(11) and (12).
B. Aligning Beneficiary Cost-Sharing for Mental Health and SUD Benefits With Those Applicable to Medical/Surgical Benefits
1. Provisions of the Proposed Rule. Following the recent repeal of statutory authority for separate beneficiary financial liability for mental health benefits, the rule eliminates any differential in cost-sharing between mental health and SUD benefits and medical/surgical benefits. The regulatory changes to 32 CFR 199.4(f) and 32 CFR 199.18 will reduce financial barriers to both outpatient and inpatient mental health and SUD benefits while, consistent with statutory requirements, minimize out-of-pocket risk for those beneficiaries.
With respect to TRICARE Prime co-payments, active duty family members (ADFMs) enrolled in TRICARE Prime will continue to pay no copayment for inpatient or outpatient services. Retirees and all other non-active duty dependents enrolled in Prime will see the following changes:
The co-pay for individual outpatient mental health visits will be reduced from
The co-pay for group outpatient mental health visits will be reduced from
The per diem charge of
Regarding TRICARE Standard cost-sharing, ADFMs utilizing TRICARE Standard/Extra previously paid a higher per diem for mental health inpatient care than for other inpatient stays. ADFMs will see the following change:
The per diem cost-share for inpatient mental health services will be reduced from
Retirees and their dependents who are not enrolled in Prime but use non-network providers (Standard) for mental health care are generally required to pay 25% of the allowable charges for inpatient care, and this will not change. Retirees and their dependents using Standard and Extra are currently responsible for their outpatient deductible and outpatient cost-sharing of 25% (Standard)/20% (Extra) of the CHAMPUS-determined allowable costs. This also will not change.
Cost-sharing for partial hospitalization programs (PHPs) will change from inpatient to outpatient to more accurately reflect the services being rendered, ensure consistency with the applicable statutes governing cost-sharing, and to further ensure parity between the surgical/medical and mental health benefit.
2. Analysis of Major Public Comments. Numerous commenters agreed that differential cost-sharing requirements have served as a further disincentive for individuals seeking treatment, and agree that aligning cost-sharing requirements will reduce financial barriers for consumers on both inpatient and outpatient mental health and SUD benefits while minimizing out-of-pocket risks for beneficiaries. One commenter noted concern regarding having retirees and their dependents pay higher copays, given high unemployment and homelessness rates among Veterans.
Response: We appreciate all of the comments in support of this important change. With respect to retirees and their dependents paying higher copays, we believe this may have been a misunderstanding of general statutory and regulatory requirements regarding TRICARE cost-sharing, and what was specifically being proposed in the rule. In general, retirees and their dependents do pay more out-of-pocket costs than ADFMs. These requirements are outlined in statute and outside the scope of this rule. The intent of the rule itself is to provide parity in cost sharing between medical/surgical benefits and SUD/mental health benefits as applied to each beneficiary class. Previously retirees and their dependents enrolled in Prime paid higher copays for inpatient and outpatient mental health services than for inpatient and outpatient medical/surgical health services. However, under the final rule retirees and all other non-active duty dependents enrolled in Prime will see reductions in individual outpatient and group outpatient mental health visits from a previous rate of
3. Provisions of the Final Rule. The final rule is consistent with the proposed rule, and no substantive changes were made regarding beneficiary cost-sharing for mental health and SUD benefits.
III. Provisions of the
A. Intensive Outpatient (IOP) Care for Psychiatric and Substance Use Disorders
1. Provisions of the Proposed Rule. Mental health and SUD IOP services were not previously identified as separate levels of care from partial hospitalization in TRICARE regulations. Although hospital-based and free-standing facilities that are TRICARE authorized to offer partial hospitalization services can provide less intensive IOP, covered at the half-day partial hospitalization rate, the previous TRICARE certification requirements for these programs restricted the typical mental health or SUD IOP from being recognized as a distinct covered benefit and TRICARE-authorized institutional provider type. SUD IOPs offer a validated level of care endorsed by
2. Analysis of Major Public Comments. Several national organizations and many commenters expressed strong support for the authorization of new services for SUD care outside of SUDRF settings, citing the need for additional treatment options consistent with the full range of the continuum of care. One national organization also requested clarification regarding application processes and contract amendments for existing TRICARE providers who serve patients in their PHP services but who would want to expand their services to include the new IOP level of care.
Response: The Department agrees and sought these revisions to ensure ready access to medically necessary treatment reflective of the full continuum of evidence-based care. The Department understands comprehensive SUD treatment must include access to various levels of care, ranging from acute detoxification to treatments that focus on stabilization and maintenance of treatment gains. While section 199.6 (b)(4)(xviii) establishes standards and requirements for intensive outpatient treatment programs for psychiatric and substance use disorders, further details regarding participation, billing, and accreditation standards will be outlined in the TRICARE manuals available online at http://manuals.tricare.osd.mil. With respect to institutional providers who would like to expand their services, we would note that the regulatory language regarding participation agreements specifically acknowledges that a single consolidated participation agreement is acceptable for all units of a TRICARE authorized facility granted that all programs meet the applicable requirements. Once implemented, interested facilities should work directly with the applicable managed care support contractor for their region to establish and/or modify their participation agreement.
3. Provisions of the Final Rule. The final rule is consistent with the proposed rule, and no substantive changes were made with respect to Intensive Outpatient (IOP) care for Psychiatric and Substance Use Disorders.
B. Treatment of Opioid Use Disorder
1. Provisions of the Proposed Rule. This rule expands treatment of opioid use disorder, with the provision of medication assisted treatment (MAT), through both TRICARE authorized institutional and individual providers. In addition to SUD IOPs, this rule allows TRICARE coverage of opioid treatment programs (OTPs), with the inclusion of a definition of OTPs in 32 CFR 199.2 and the requirements for OTPs to become TRICARE authorized institutional providers outlined in 32 CFR 199.6(b)(4)(xix). Additionally, this rule allows coverage of OBOT, as defined in 32 CFR 199.2, and coverage of MAT on an outpatient basis as extended in 32 CFR 199.4(c)(3)(ix)(A)(9).
2. Analysis of Major Public Comments. A number of commenters, along with multiple national organizations sent comments in support of the addition of benefit coverage to include opioid treatment programs, noting opioid addiction is a significant national problem. One commenter stated that individuals with opioid use disorder should not be provided any form of treatment as this represented a waste of government funds. One national organization commented that there are actually approximately 1400 OTPs in existence. Also, several commenters requested that TRICARE clarify capacity requirements for OTPs and include the right to request a waiver to this requirement. One commenter queried how and if quality tracking of the newly authorized providers will be performed and by which department.
Response: Recent increases in prescription opioid misuse and heroin addiction make provision of MAT in OTPs and OBOT settings a timely and necessary addition to benefit coverage. We do not agree with the commenter who noted that treatment should be withheld for individuals with opioid use disorder, and we note that MAT is an effective, evidence-based treatment for opioid use disorder that should be provided by TRICARE as medically necessary and appropriate treatment. We appreciate the comment regarding the approximate number of OTPs in existence and are hopeful many of these facilities will elect to become TRICARE participating providers. With respect to the proposed regulatory requirement that OTPs are required to be licensed and fully operational for a period of at least six months with a minimum patient census of at least 30 percent of capacity, we understand from several commenters that unlike inpatient and residential facilities, OTPs may not have a stated capacity as part of their licensure, and as a result, it may not be clear as to whether or not OTPs have met this requirement. We appreciate this issue being brought to our attention and have decided to remove the explicit capacity requirement for OTPs from the regulation. TRICARE will simply require OTPs to be licensed and operate in substantial compliance with state and federal regulations.
3. Provisions of the Final Rule. The final rule is consistent with the proposed rule and the only substantive change made regarding provisions for the treatment of opioid use disorder was removal of an explicit capacity requirement for OTPs contained in section 199.6(b)(xix)(A)(2) (ii).
C. Outpatient Substance Use Disorder Treatment by Individual Professional Providers
1. Provisions of the Proposed Rule. By previous regulation, reimbursement for office-based SUD outpatient treatment provided by TRICARE authorized individual mental health providers, as specified in 32 CFR 199.6, was not permitted. Such outpatient SUD treatment services were only authorized when provided by a TRICARE approved institutional provider (i.e., a hospital-based or free-standing SUDRF). However, although some accredited TRICARE-authorized SUDRFs provide office-based SUD outpatient treatment, institutional providers of SUD care primarily provide services to patients requiring a higher level of SUD care. To address this limitation in access, the Department proposed expanded coverage to include individual outpatient SUD care, including office-based outpatient treatment.
This rule covers services of TRICARE-authorized individual mental health providers, practicing within the scope of their licensure or certification, who offer medically or psychologically necessary SUD treatment services (including outpatient and family therapy) outside of a SUDRF, to include MAT and treatment of opioid use disorder by a TRICARE authorized physician delivering OBOT on an outpatient basis.
2. Analysis of Major Public Comments. Again, national organizations and many commenters expressed strong support for the authorization of new services for SUD care outside of SUDRF settings, citing the need for additional treatment options consistent with the full range of the continuum of care and appropriate access to evidence-based care. Eight commenters requested additional SUD individual professional provider types be recognized by TRICARE as authorized to provide services. One commenter also noted that she was unable to provide services as she does not hold citizenship but suggested volunteers be allowed to provide services to beneficiaries.
Response: We agree that access to care is important for beneficiaries seeking SUD treatment. The Department made these revisions in acknowledgement of the importance of both the availability and convenience of access to evidence-based care in a range of settings to include TRICARE authorized, individual office-based providers.
TRICARE appreciates the contributions of peer counselors, and other non-medical individuals who desire to provide SUD and mental health services to beneficiaries as well as the skills and professional experience of the various substance use disorder and mental health providers in the field. We appreciate these comments but consider them beyond the scope of this rule as we did not propose any changes to the existing regulatory requirements for individual professional providers of care. TRICARE maintains a robust selection of TRICARE eligible providers by relying on currently recognized provider types. Qualified mental health providers are: Psychiatrists or other physicians; clinical psychologists, certified psychiatric nurse specialists, certified clinical social workers, certified marriage and family therapists, TRICARE certified mental health counselors, pastoral counselors under a physician's supervision, and supervised mental health counselors under a physician's supervision. However, we will review all recommendations provided and consider them in the development of future policy. Additionally, the acceptance of volunteer services is beyond the scope of our proposed rule which addresses the cost-sharing of medically necessary services and supplies required in the diagnosis and treatment of an injury, illness or disease when rendered by a TRICARE authorized provider.
3. Provisions of the Final Rule. The final rule is consistent with the proposed rule, and no substantive changes were made to provisions regarding TRICARE coverage of outpatient SUD treatment by individual professional providers.
Editor's note: For the full-text of this document, click this link or copy it into your browser: https://www.federalregister.gov/articles/2016/09/02/2016-21125/tricare-mental-health-and-substance-use-disorder-treatment.
[FR Doc. 2016-21125 Filed 9-1-16;
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