Black Lung Benefits Act: Medical Benefit Payments, 27690-27699 [2018-12418]

Download as PDF 27690 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations AIRAC date State City Airport FDC No. 8/8711 5/21/18 VOR Rwy 19, Amdt 8 8/9092 5/21/18 8/9547 8/9658 8/9659 8/9660 8/9661 8/9662 5/21/18 5/21/18 5/21/18 5/21/18 5/21/18 5/21/18 Takeoff Minimums and Obstacle DP, Amdt 2 RNAV (GPS) Rwy 27, Amdt 1A ILS OR LOC/DME Rwy 7, Orig-C NDB Rwy 25, Amdt 10C RNAV (GPS) Rwy 25, Amdt 1C RNAV (GPS) Rwy 7, Amdt 1C VOR/DME–A, Amdt 1A 19-Jul-18 ...... NE Norfolk ................... 19-Jul-18 ...... MO St Louis ................. Norfolk Rgnl/Karl Stefan Memorial Fld. Creve Coeur .......................... 19-Jul-18 19-Jul-18 19-Jul-18 19-Jul-18 19-Jul-18 19-Jul-18 MA SC SC SC SC SC Beverly .................. Aiken ..................... Aiken ..................... Aiken ..................... Aiken ..................... Aiken ..................... Beverly Rgnl .......................... Aiken Muni ............................ Aiken Muni ............................ Aiken Muni ............................ Aiken Muni ............................ Aiken Muni ............................ ...... ...... ...... ...... ...... ...... BILLING CODE 4910–13–P DEPARTMENT OF LABOR Office of Workers’ Compensation Programs 20 CFR Part 725 RIN 1240–AA11 Black Lung Benefits Act: Medical Benefit Payments Office of Workers’ Compensation Programs, Labor. ACTION: Final rule. AGENCY: This final rule revises the regulations under the Black Lung Benefits Act (BLBA or Act) governing the payment of medical benefits and maintains the level of care available to miners. The final rule establishes methods for determining the amounts that the Black Lung Disability Trust Fund (Trust Fund) will pay for covered medical services and treatments provided to entitled miners. The Department based the rule on payment formulas that the Centers for Medicare & Medicaid Services (CMS) uses to determine payments under the Medicare program, which are similar to the formulas used by other programs that the Office of Workers’ Compensation Programs (OWCP) administers. The Department is adopting these payment formulas for the black lung program because they more accurately reflect prevailing community rates for authorized treatments and services than do the internally-derived payment formulas that OWCP currently uses. In addition, the final rule eliminates two obsolete provisions. DATES: Effective Date: This rule is effective August 31, 2018. Applicability Dates: Sections 725.708(d), 725.709, and 725.711 apply to medical equipment, prescription drugs, and inpatient medical services provided or rendered after August 31, daltland on DSKBBV9HB2PROD with RULES VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 Subject responsible operator fails to meet its payment obligations on an effective award (see 20 CFR 725.502). For interim payments made pending final adjudication, OWCP seeks reimbursement from the operator after the claim is finally awarded. 20 CFR 725.602(a). Likewise, OWCP seeks reimbursement for payments made when an operator fails to meet its obligations on an effective award. 20 CFR 725.601. Although the current regulations provide that medical services and supplies be paid at the rate prevailing in the community where the physician, medical facility or supplier is located, I. Background of This Rulemaking they do not address how the prevailing community rate should be determined. The BLBA, 30 U.S.C. 901–944, See 20 CFR 725.706(c). OWCP currently provides for the payment of benefits to bases Trust Fund payments for coal miners and certain of their dependent survivors on account of total professional medical services, medical equipment, and inpatient and outpatient disability or death due to coal workers’ pneumoconiosis. 30 U.S.C. 901(a); Usery medical services and treatments on internally-derived payment formulas. v. Turner Elkhorn Min. Co., 428 U.S. 1, For prescription medications, OWCP 5 (1976). A miner who is entitled to uses a payment formula similar to that disability benefits under the BLBA is employed by the three other workers’ also entitled to medical benefits. 33 U.S.C. 907, as incorporated by 30 U.S.C. compensation programs that it administers. 932(a); 20 CFR 725.701. Those medical On January 4, 2017, the Department benefits entitle a miner to medical, surgical, and other treatment—including issued a Notice of Proposed Rulemaking hospital services, medicine, equipment, (NPRM), proposing a revised Subpart J. 82 FR 739–770 (Jan. 4, 2017). and supplies—for his or her Specifically, the Department proposed pneumoconiosis and related disability. to base Trust Fund payments for all 20 CFR 725.701(b). The rules governing medical services and treatments the payment of medical benefits are rendered on or after the effective date of contained in 20 CFR part 725, subpart the rule on payment formulas derived J. Benefits are paid by either a from those used by CMS under the ‘‘responsible’’ coal mine operator (or its Medicare program. Id. at 740. The insurance carrier), or the Trust Fund. proposed payment formulas were Director, OWCP v. Bivens, 757 F.2d 781, similar to those used by other OWCP 783 (6th Cir. 1985); see 20 CFR 725.495 programs, but were tailored to the (criteria for determining a responsible specific geography, medical conditions, operator). OWCP pays medical benefits and needs of black lung program from the Trust Fund in three instances: stakeholders. See id. at 767 (proposed (1) If no responsible operator can be § 725.707). The Department chose these payment identified as the party liable for a claim, formulas for several reasons. The and the Trust Fund is liable as a result proposed formulas more accurately (see 20 CFR 725.701(b)); (2) when the identified responsible operator declines reflected prevailing community rates for authorized treatments and services than to pay benefits pending final did OWCP’s internally-derived adjudication of a claim (see 20 CFR formulas. Id. at 740. In addition, 725.522, 725.708(b)); and (3) when the 2018. Sections 725.708(a) and (b) and 725.710 apply to professional medical services and outpatient medical services rendered after November 30, 2019. FOR FURTHER INFORMATION CONTACT: Michael A. Chance, Director, Division of Coal Mine Workers’ Compensation, Office of Workers’ Compensation Programs, U.S. Department of Labor, 200 Constitution Avenue NW, Suite N– 3520, Washington, DC 20210. Telephone: 1–800–347–2502. This is a toll-free number. TTY/TDD callers may dial toll-free 1–800–877–8339 for further information. SUPPLEMENTARY INFORMATION: [FR Doc. 2018–12710 Filed 6–13–18; 8:45 am] SUMMARY: FDC date PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations because responsible operators and their insurance carriers utilize payment formulas or fee schedules that are substantially similar to the proposed payment formulas, use of such formulas would more likely lead operators to reimburse fully the Trust Fund for the payments the Trust Fund makes on an interim basis. Id. Thus, the proposed rule would control the health care costs associated with the BLBA, conserve the Trust Fund’s limited resources, and provide greater clarity and certainty with respect both to fees paid to providers and reimbursements sought from operators and carriers. The rule would also ensure more consistent payment policies across all of the programs administered by OWCP. Id. The public comment period closed on March 6, 2017. The Department has fully evaluated these comments and has determined that proceeding with a final rule is in the best interests of the stakeholders and the program’s administration. II. Statutory Authority Section 426(a) of the BLBA, 30 U.S.C. 936(a), authorizes the Secretary of Labor to prescribe rules and regulations necessary for the administration and enforcement of the BLBA. The Secretary is also explicitly empowered to promulgate regulations addressing medical fees and charges, including determining the prevailing community rate. 33 U.S.C. 907(g), as incorporated by 30 U.S.C. 932(a). daltland on DSKBBV9HB2PROD with RULES III. Discussion of Significant Comments The Department received eleven comments on the proposed regulations. Most of these comments focus on a few substantive issues. Some commenters generally supported OWCP’s efforts to modernize the medical payment formulas and no commenters expressed overall objections to the promulgation of these rules. Several commenters applauded the technical changes made to several rules to simplify and clarify the language, such as replacing the term ‘‘Office’’ with ‘‘OWCP.’’ No negative comments were received on the following revised or new regulations: §§ 725.308, 725.701, 725.702, 725.703, 725.704, 725.706, 725.708, 725.711, 725.712, and 725.714–725.720. Thus, the Department is promulgating these regulations as proposed. The Department received one negative comment on the substantive provisions of § 725.705 (titled ‘‘Is prior authorization for medical services required?’’), but the Department proposed only technical changes to this rule and did not open it for substantive VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 comment. Thus, the Department is promulgating § 725.705 as proposed. In addition to comments received on specific sections of the proposed rules (discussed below in the Section-bySection Explanation), a few commenters offered more general comments. One suggested that the medical bill payment rules should contain provisions allowing the Director to sue operators who fail to properly reimburse the Trust Fund for medical benefit payments made on their behalf. The BLBA incorporates various provisions of the and Harbor Workers’ Compensation Act, 33 U.S.C. 918(a), 921(d), as incorporated by 30 U.S.C. 932(a), that already provide the Department with authority to undertake such suits. See generally 20 CFR 725.601–725.605 (regulations implementing enforcement of liability against operators). The implementing regulations clarify that these enforcement tools may be used when an operator fails to reimburse the Trust Fund for medical benefits. 20 CFR 725.602(a). Thus, the Department does not believe that any additional authority is necessary. Another commenter requested that the Department specify when OWCP will exercise its discretion to modify or change payment formulas or parts thereof as provided in several proposed regulations. See proposed §§ 725.707, 725.708, 725.709, 725. 710, 725.711. The vast majority of payments for medical services and treatments will be determined under the payment formulas set out in these regulations. The provisions giving OWCP discretion to modify or change payment formulas are intended to allow OWCP to respond quickly to unique or novel medical, technological, or financial circumstances that arise in implementing the payment formulas both initially and over time. The Department cannot predict when that might occur, and thus cannot specify when OWCP would take such discretionary actions. Finally, the Department has determined that a two-phase implementation of this rule will be more efficient and cost-effective, allow sufficient time to update and improve its computer processes, and result in less disruption, than implementing the entire rule at once. Except for §§ 725.708(a) and (b) and 725.710, all provisions of this rule (including the payment formulas for medical equipment, prescription drugs and inpatient medical services) will apply to services and treatments rendered after the effective date of the rule, August 31, 2018. The Department can apply these regulations immediately because they PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 27691 either codify existing practices or require easily implemented modifications to current payment processes. The provisions of §§ 725.708(a) and (b) and 725.710 (governing the payment of professional medical services and outpatient medical services) will apply to services and treatments rendered after November 30, 2019. Both regulations would require extensive modifications to the existing computer processes for full implementation. The Department is currently transitioning to a new computer system and will realize costsavings by building the new payment methodologies into that system rather than modifying the existing one. The Department has revised three provisions (§§ 725.707, 725.708 and 725.710) to reflect the two-phase implementation. The changes to each provision are discussed in the Section-by-Section Explanation. Section-by-Section Explanation 20 CFR 725.707 At what rate will fees for medical services and treatments be paid? (a) Section 725.707 is a new provision that sets out general rules governing the payment of compensable medical bills by the Trust Fund. It provides that the Trust Fund will pay no more than the prevailing community rate for medical services, treatments, drugs or equipment, and that the prevailing community rate for various types of treatments and services will generally be determined under the provisions of §§ 725.708–725.711. Where the provisions of §§ 725.708–725.711 cannot be used to determine the prevailing community rate, the rule permits OWCP to determine the prevailing community rate based on other payment formulas or evidence. This section also requires OWCP to review the payment formulas in §§ 725.708–725.711 annually, and permits OWCP to adjust, revise or replace any formula (or its components) when needed. (b) Four commenters express concern that the proposed payment formulas may have a negative impact on miners’ access to care. This concern stems from the fact that reduced payments will result in some circumstances under the proposed rules. One commenter believes that rural Appalachia would feel the greatest impact. The Department agrees that maintaining miners’ access to care is of paramount importance in implementing the payment formulas for various services and treatments. In fact, OWCP made access to care a primary E:\FR\FM\14JNR1.SGM 14JNR1 27692 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES consideration during the development of the proposed rules. Although the text of proposed § 725.707 does not directly address impact on access to care, the NPRM’s preamble makes repeated reference to this concern and expresses OWCP’s intent to continually review the payment formulas to ensure that they do not adversely impact access to care. In particular, the rule requires OWCP to review the payment formulas at least annually and revise them if needed, § 725.707(e), and the preamble to this provision makes clear that it is intended to allow OWCP to quickly make changes to the formulas if they ‘‘are adversely impacting miners’ access to care, or are otherwise not appropriate.’’ 82 FR 742; see also id. at 740, 746, 748, 749, 752. These changes could include adjustments for particular geographic areas. Nonetheless, the commenters’ general concern is important and the Department agrees that maintaining access to care should be codified in the regulation. Thus, the Department has revised § 725.707(e) in the final rule to specifically require that OWCP consider and ensure miners’ access to care in its annual review of the payment formulas in §§ 725.708–.725.711. The Department believes that this clarification of its intent will prevent miners’ access to care from being negatively affected by the new payment formulas. (c) Finally, the Department has revised § 725.707(f) to reflect the phased implementation of this rule. This paragraph now provides that the provisions of the rule apply to all medical services or treatments rendered after the effective date of the rule (August 31, 2018), except as otherwise noted in the rule. A different application date for the payment formulas for professional medical services and outpatient medical services is now provided in §§ 725.708 and 725.710. These regulations apply to services and treatments rendered after November 30, 2019. 20 CFR 725.708 How are payments for professional medical services and medical equipment determined? Section 725.708 is a new provision governing payment for professional medical services and medical equipment. No comments were received on this provision. The Department, however, has revised the provision to reflect the phased implementation of this rule. The Department has added a new paragraph (c), which states that the provisions of paragraphs (a) and (b) apply to professional medical services rendered after November 30, 2019. This later applicability date does not apply to VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 payments for medical equipment, which are instead governed by the general applicability date in § 725.707(f). The Department has also renumbered paragraph (c) of the proposed rule (dealing with payment for medical equipment) as paragraph (d). 20 CFR 725.709 How are payments for prescription drugs determined? (a) Section 725.709 is a new provision governing payment for compensable prescription drugs. The regulation codifies existing policy and does not change current payment practice. It is also consistent with the payment practices of the other programs that OWCP administers. Section 725.709 generally provides for payment for prescribed medication at a percentage of the national average wholesale price (or another baseline price designated by OWCP) for a particular medication, plus a flat-rate dispensing fee. It also provides that OWCP may, in its discretion, require the use of specific providers for certain medications. (b) One commenter asks OWCP to specify when miners will be required to use specific providers for certain medications. The comment also requests clarification of whether OWCP will directly negotiate with drug manufacturers, presumably with respect to the cost of medications. The Department declines to revise the regulation in response to this comment. OWCP does not currently require the use of specific providers for any medication under the BLBA. The provision in § 725.709 gives OWCP the option of doing so in the future if it would be in the best interests of both the agency and the program’s stakeholders. It is not possible to predict or specify when OWCP might use this option. OWCP, however, would advise miners and providers before any such requirement were implemented. With respect to negotiating drug prices with drug manufacturers, OWCP is a thirdparty payer and does not directly purchase medications or distribute them to miners. 20 CFR 725.710 How are payments for outpatient medical services determined? (a) Section 725.710 is a new provision governing payment for compensable outpatient medical services. As proposed, it provides that, where appropriate, OWCP will utilize the Outpatient Prospective Payment System (OPPS) devised by CMS for the Medicare program. The proposed rule also states that where outpatient services cannot be assigned or priced appropriately under the OPPS system, payment will be based on fee schedules PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 and other pricing formulas utilized by OWCP. (b) One commenter requested clarification of the proposed rules with respect to payments that would be made to Critical Access Hospitals (CAHs) for outpatient hospital services. CAHs are small hospitals (generally 25 beds or less) in isolated rural areas (35 miles or more from another hospital, 15 or more miles in mountainous areas) that provide emergency services and offer short-term (generally less than 96 hours) inpatient services. See 42 U.S.C. 1395i– 4, 1395x; 42 CFR 485.601–485.647. Medicare uses different payment formulas for services and treatments at CAHs than those used to pay other hospitals. In particular, Medicare excludes CAHs from both its inpatient and outpatient prospective payment systems. The commenter notes that under proposed § 725.711 (inpatient hospital services), services at facilities (such as CAHs) that are excluded from Medicare’s Inpatient Prospective Payment System will be paid under fee schedules or other pricing formulas. The commenter requests clarification of whether a similar policy will be applied for outpatient services, given that CAHs are excluded from Medicare’s OPPS. The commenter also requests that the Department consider undertaking additional economic analysis of applying the OPPS to CAHs. During the development of the proposed rules, OWCP determined that CAHs would be exempt from the new outpatient and inpatient prospective payment systems generally applicable to other hospitals, as CAHs are excluded from Medicare’s prospective payment systems. While this determination was codified in the inpatient regulation (§ 725.711), it was omitted from the outpatient regulation (§ 725.710). The Department agrees with the commenter that § 725.710 should be revised to clarify that the outpatient payment formula described in paragraph (a) of the provision does not apply to services at facilities (such CAHs) that are excluded from Medicare’s OPPS. Thus, the Department has revised § 725.710(b) in the final rule to provide that services at such facilities will be paid ‘‘based on fee schedules or other pricing formulas utilized by OWCP for outpatient services.’’ This revision mirrors the inpatient rule and is consistent with Medicare’s exclusion of CAHs from its OPPS. Since the Department has revised § 725.710 to exclude CAHs from the general payment formula, there is no need to analyze the economic impact of that formula on CAHs. (c) Finally, the Department has revised § 725.710 to reflect the phased E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations implementation of this rule. The Department has added a new paragraph (d), which states that the provisions of this section apply to outpatient medical services rendered after November 30, 2019. daltland on DSKBBV9HB2PROD with RULES 20 CFR 725.713 If a fee is reduced, may a provider bill the claimant for the balance? (a) Section 725.713 is a new provision addressing reductions in requested fees. The proposed regulation provides that if a billed fee has been reduced (i.e., only paid in part) in accordance with the provisions of Subpart J, providers may not recover any additional amount from the miner. It, thus, prohibits the practice of ‘‘balance billing,’’ which occurs when providers receive only a portion of their submitted charges from third-party payers and seek to recover the ‘‘balance’’ from the patient. (b) Three commenters request that the proposed rule be extended to prohibit balance billing where OWCP makes no payment for a treatment or service, as well as where the agency makes partial payment. The commenters also request that the principle that disabled miners and their families should never have to make any payments for covered treatments and services under the BLBA be explicitly stated in the rule. It is OWCP’s longstanding position and practice that miners should not be subject to balance billing for treatments and services that are covered under these regulations. To make this clear, the Department has revised § 725.713 in the final rule to explicitly state that providers cannot bill miners for, and that miners are not required to pay, any remaining balance for any treatments or services provided pursuant to this subpart (i.e., that are for a miner’s disabling pneumoconiosis) after OWCP makes partial payment for such treatments and services. See also discussion at § 725.717 (noting similar revision). OWCP, however, has no legal authority to pay bills for services or treatments not covered under the BLBA (i.e., that are unrelated to a miner’s disabling pneumoconiosis), or to regulate the payment and collection of such bills. Thus, the Department declines to extend § 725.713 to situations where OWCP denies payment entirely for noncovered services or treatments. § 725.717 What are the time limitations for requesting payment or reimbursement for covered medical services or treatments? (a) Section 725.717 is a new provision setting time limits on the submission of bills by providers and reimbursement VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 requests by miners. Bills and reimbursement requests must be submitted within one year of either (1) the end of the calendar year in which the service or treatment was provided or (2) the end of the calendar year in which the miner’s entitlement to benefits was finally adjudicated, whichever is later. OWCP may waive these time limits for good cause shown. (b) As discussed under § 725.713, several commenters asked the Department to clarify in the regulations that miners are not required to pay for covered treatments and services. The Department agrees with the commenters’ point. Thus, in addition to revising § 725.713, the Department has revised the title and text of § 725.717 to clarify that a provider may not seek reimbursement from a miner when OWCP denies an otherwisecompensable bill due to late submission. IV. Information Collection Requirements (Subject to the Paperwork Reduction Act) Imposed Under the Proposed Rule The Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., and its implementing regulations, 5 CFR part 1320, require that the Department consider the impact of paperwork and other information collection burdens imposed on the public. A federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the Office of Management and Budget (OMB) under the PRA and displays a current, valid OMB Control Number. In addition, no person may generally be subject to penalty for failing to comply with an information collection that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. Although the medical benefit payment rules in Subpart J contain collections of information within the meaning of the PRA (see §§ 725.715– 725.716), these collections are not new. They are currently approved for use in the black lung program and other OWCP-administered compensation programs by OMB under Control Numbers 1240–0007 (OWCP–915 Claim for Medical Reimbursement); 1240–0019 (OWCP–04 Uniform Billing Form); 1240–0021 (OWCP–1168 Provider Enrollment Form); 1240–0037 (OWCP– 957 Medical Travel Refund Request); and 1240–0044 (OWCP–1500 Health Insurance Claim Form). The requirements for completion of the forms and the information collected on the forms do not change under this rule. PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 27693 Since no changes are being made to the collections, the overall burdens imposed by them also will not change. While the Department has determined that the rule does not affect the general terms of the information collections or their associated burdens, consistent with requirements codified at 44 U.S.C. 3506(a)(1)(B), (c)(2)(B) and 3507(a)(1)(D); 5 CFR 1320.11, the Department submitted a series of Information Collection Requests (ICRs) to OMB for approval concurrent with the NPRM to update the information collections to reflect this rulemaking and provide interested parties a specific opportunity to comment under the PRA. The NPRM specifically invited comments regarding the information collection and notified the public of their opportunity to file such comments with both OMB and the Department. 82 FR 742. On March 6, 2017, OMB concluded its review of the ICRs by asking the Department to submit updated ICRs at the final rule stage after considering any public comments regarding the information collection requirements in the rule. While the Department received comments on the substance of the proposed rule, which are addressed in the Section-by-Section Explanation above, it received no comments about the information collection burdens. The Department submitted updated ICRs to OMB for the information collections in this final rule. See ICR Reference Numbers 1240–0007: 201805– 1240–0006; 1240–0019: 201805–1240– 0005; 1240–0021: 201805–1240–0004; 1240–0037: 201805–1240–0003; and 1240–0044: 201805–1240–0002. A copy of these requests (including supporting documentation) may be obtained free of charge from the Reginfo.gov website at www.Reginfo.gov or by contacting Michael A. Chance, Director, Division of Coal Mine Workers’ Compensation, Office of Workers’ Compensation Programs, U.S. Department of Labor, 200 Constitution Avenue NW, Suite N– 3464, Washington, DC 20210. Telephone: (202) 693–0978 (this is not a toll-free number). TTY/TDD callers may dial toll-free 1–800–877–8339. Concurrent with its approval of this rule, OMB also approved the updated ICRs. The information collections in this rule are summarized as follows. The number of responses and burden estimates listed are not specific to the black lung program; instead, the estimates are cumulative for all OWCPadministered compensation programs that collect this information. E:\FR\FM\14JNR1.SGM 14JNR1 27694 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 1. Title of Collection: Claim for Medical Reimbursement Form (OWCP– 915). OMB Control Number: 1240–0007. Total Estimated Number of Responses: 34,564. Total Estimated Annual Time Burden: 5,738 hours. Total Estimated Annual Other Costs Burden: $59,450. 2. Title of Collection: Uniform Billing Form (OWCP–04). OMB Control Number: 1240–0019. Total Estimated Number of Responses: 259,865. Total Estimated Annual Time Burden: 29,466 hours. Total Estimated Annual Other Costs Burden: $0. 3. Title of Collection: Provider Enrollment Form (OWCP–1168). OMB Control Number: 1240–0021. Total Estimated Number of Responses: 64,325. Total Estimated Annual Time Burden: 8,555 hours. Total Estimated Annual Other Costs Burden: $33,449. 4. Title of Collection: Medical Travel Refund Request (OWCP–957). OMB Control Number: 1240–0037. Total Estimated Number of Responses: 333,528. Total Estimated Annual Time Burden: 55,366 hours. Total Estimated Annual Other Costs Burden: $173,435. 5. Title of Collection: Health Insurance Claim Form (OWCP–1500). OMB Control Number: 1240–0044. Total Estimated Number of Responses: 3,381,232. Total Estimated Annual Time Burden: 321,455 hours. Total Estimated Annual Other Costs Burden: $0. daltland on DSKBBV9HB2PROD with RULES V. Executive Orders 12866 and 13563 (Regulatory Planning and Review) Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It also instructs agencies to review ‘‘rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them.’’ The Department has considered the final rule with these VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 principles in mind and has determined that the regulated community will benefit from this regulation. The Department addressed these issues in the NPRM. 82 FR 745–752. The Department comprehensively analyzed the potential economic impact of the new payment formulas and determined that they would not have a significant impact on either the economy as a whole or on firms that provide black lung-related health care to entitled miners. 82 FR 745–751. Comparing Trust Fund medical benefit payments for Fiscal Year 2014 with payment amounts that would be made under the proposed regulations for the same services, the Department estimated an aggregate $3,154,297 annual reduction in Trust Fund payments under the proposed payment formulas. 82 FR 751. Further analysis revealed that even for negatively affected providers, the proposed rule would not have significant impact on individual firms. Id. The Department also noted the rule’s multiple advantages that serve the interests of stakeholders. 82 FR 752. The proposed formulas would bring Trust Fund payments in line with industry standards, help protect the Trust Fund from inaccurate and excessive payments, ease recouping of medical benefits paid by the Trust Fund on a liable operator’s behalf, and conserve the Trust Fund’s limited resources. Id. Additionally, the new formulas would decrease administrative costs, reduce disparities in provider reimbursements, shorten the time period providers must wait for reimbursement, and provide all stakeholders with greater clarity and certainty regarding the black lung medical benefit payment process. Id. The Department received one comment suggesting that the economic analysis in the NPRM improperly focused solely on the nation-wide impacts of the proposed rules. This is incorrect. In addition to considering the overall impact of the proposed rules, the analysis addressed the impact of the proposed payment formulas on a stateby-state basis. See 82 FR 746–751. The same commenter takes issue with a statement in the NPRM’s economic analysis that any decline in the number of entitled claimants may result in a decline in payments by the Trust Fund, even apart from any change in payments resulting from the new payment formulas. See 82 FR 751. The commenter suggests that claims filed by miners with complicated pneumoconiosis, a more serious form of the disease, are in fact increasing in certain areas. The Department did not mean to suggest that miners would be PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 less likely to contract pneumoconiosis in the future or that the number of claims filed could not fluctuate from year to year. Rather, the Department was simply noting that there had been a long-term decline in both the number of beneficiaries covered, and medical benefit payments made, by the Trust Fund. See id., n.17. The Department received no other comments calling its cost-benefit analysis into question. Thus, the Department continues to believe that the cost savings and other benefits of this rule support its promulgation. The Office of Information and Regulatory Affairs of the Office of Management and Budget has determined that this rule is a ‘‘significant regulatory action’’ under section 3(f)(4) of Executive Order 12866 and has reviewed it. VI. Regulatory Flexibility Act and Executive Order 13272 (Proper Consideration of Small Entities in Agency Rulemaking) The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601 et seq., and Executive Order 13272 require agencies to review proposed and final rules to assess their impact on small entities. The agency must determine whether a proposed rule may have a ‘‘significant’’ economic impact on a ‘‘substantial’’ number of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions. See 5 U.S.C. 603. If the agency estimates that a proposed rule would have a significant impact on a substantial number of small entities, then it must prepare an initial regulatory flexibility analysis as described in the RFA. Id. The RFA also requires agencies to prepare a final regulatory flexibility analysis when promulgating a final rule. 5 U.S.C. 604. However, the RFA does not require a regulatory flexibility analysis if the agency certifies that the proposed or final rule will not have a significant economic impact on a substantial number of small entities and provides the factual basis for the certification. 5 U.S.C. 605. The Department has determined that a final regulatory flexibility analysis is not required for this rulemaking. The Department conducted an initial regulatory flexibility analysis to aid understanding of the impact of the proposed rule and invited comments on all aspects of the costs and benefits of the proposed rule, with particular attention to the effects of the rule on small entities. See 82 FR 752–765. To determine whether the rule would have a significant impact on a small entity, E:\FR\FM\14JNR1.SGM 14JNR1 daltland on DSKBBV9HB2PROD with RULES Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations the Department used as its standard whether the rule would impose costs that equal or exceed 3% or more of the entity’s annual revenue. 82 FR 752. Applying this standard, the Department considered whether the rule would significantly impact 15% or more of the small entities in the relevant industry. 82 FR 752–53. The Department separately examined the rule’s impact on small entities of each provider type (non-hospital health care services providers, hospitals providing outpatient services, and hospitals providing inpatient services) affected by the rule. 82 FR 753–764. The Department estimated that the rule will not have a significant impact on any small entity providing non-hospital health care services. 82 FR 759. The Department estimated that one small hospital entity providing outpatient services and two providing inpatient services will be significantly impacted, but these entities do not constitute a substantial number of the total number of negatively affected small hospitals providing either outpatient or inpatient services. 82 FR 761, 763. The Department noted that its analysis likely overstated the impact of the rule on negatively affected small entities. 82 FR 765. The Department therefore concluded that the rule, if adopted, would not have a significant impact on a substantial number of small entities. Id. No comments were received that raise a significant issue regarding the initial regulatory flexibility analysis or that provide a basis for departing from the conclusion reached in the analysis. Significantly, with the exception of CAHs, no commenter or interested small business brought forth any information that contradicts the Department’s assumptions or conclusions in the initial regulatory flexibility analysis, despite the Department’s specific request for comments about adverse effects on small businesses. And the Department’s determination, as explained in the Section-by-Section Explanation above, to exclude CAHs from the new payment formulas renders the request to analyze the impact of those formulas on CAHs moot. Based on these facts, the Department certifies for the purposes of 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. Accordingly, it has not prepared a final regulatory impact analysis. The Department will provide the Chief Counsel for Advocacy of the Small Business Administration with a copy of this certification. See 5 U.S.C. 605. VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 VII. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) This final rule is not subject to the requirements of Executive Order 13771 because this final rule addresses transfer costs and does not impose any new requirements apart from the transfers. OMB’s interim guidance on E.O. 13771 (Para II, Q2) (February 2, 2017) and OMB additional guidance on E.O. 13771 (Para III, Q13) (April 5, 2017); see also 82 FR 746, 748–49 (recognizing rules as implicating transfer costs). VIII. Unfunded Mandates Reform Act of 1995 Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 et seq., directs agencies to assess the effects of Federal Regulatory Actions on State, local, and tribal governments, and the private sector, ‘‘other than to the extent that such regulations incorporate requirements specifically set forth in law.’’ 2 U.S.C. 1531. For purposes of the Unfunded Mandates Reform Act, this rule does not include any Federal mandate that may result in increased expenditures by State, local, tribal governments, or increased expenditures by the private sector of more than $100,000,000. IX. Executive Order 13132 (Federalism) The Department has reviewed this rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have ‘‘federalism implications.’’ The rule will not ‘‘have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.’’ Id. X. Executive Order 12988 (Civil Justice Reform) This rule meets the applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. XI. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a report, which includes a copy of the rule, to each House of Congress and to the Comptroller General of the United States. OWCP will report this rule’s promulgation to each House of Congress and the Comptroller General PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 27695 simultaneously with publication of the rule in the Federal Register. The report will state that the rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 20 CFR Part 725 Administrative practice and procedure, Black lung benefits, Claims, Coal miners’ entitlement to benefits, Health care, Reporting and recordkeeping requirements, Survivors’ entitlement to benefits, Total disability due to pneumoconiosis, Vocational rehabilitation, Workers’ compensation. For the reasons set forth in the preamble, the Department of Labor amends 20 CFR part 725 as follows: PART 725—CLAIMS FOR BENEFITS UNDER PART C OF TITLE IV OF THE FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED 1. The authority citation for part 725 continues to read as follows: ■ Authority: 5 U.S.C. 301; 28 U.S.C. 2461 note (Federal Civil Penalties Inflation Adjustment Act of 1990); Pub. L. 114–74 at sec. 701; Reorganization Plan No. 6 of 1950, 15 FR 3174; 30 U.S.C. 901 et seq., 902(f), 921, 932, 936; 33 U.S.C. 901 et seq.; 42 U.S.C. 405; Secretary’s Order 10–2009, 74 FR 58834. 2. Amend § 725.308 as follows: a. Remove paragraph (b); b. Redesignate paragraph (c) as paragraph (b); ■ c. Remove from the second sentence in redesignated paragraph (b) ‘‘However, except as provided in paragraph (b) of this section, the’’ and add in its place ‘‘The’’. ■ 3. In part 725, revise subpart J to read as follows: ■ ■ ■ Subpart J—Medical Benefits and Vocational Rehabilitation Sec. 725.701 What medical benefits are available? 725.702 Who is considered a physician? 725.703 How is treatment authorized? 725.704 How are arrangements for medical care made? 725.705 Is prior authorization for medical services required? 725.706 What reports must a medical provider give to OWCP? 725.707 At what rate will fees for medical services and treatments be paid? 725.708 How are payments for professional medical services and medical equipment determined? 725.709 How are payments for prescription drugs determined? 725.710 How are payments for outpatient medical services determined? 725.711 How are payments for inpatient medical services determined? 725.712 When and how are fees reduced? 725.713 If a fee is reduced, may a provider bill the claimant for the balance? 725.714 How do providers enroll with OWCP for authorizations and billing? E:\FR\FM\14JNR1.SGM 14JNR1 27696 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 725.715 How do providers submit medical bills? 725.716 How should a miner prepare and submit requests for reimbursement for covered medical expenses and transportation costs? 725.717 What are the time limitations for requesting payment or reimbursement for covered medical services or treatments? 725.718 How are disputes concerning medical benefits resolved? 725.719 What is the objective of vocational rehabilitation? 725.720 How does a miner request vocational rehabilitation assistance? Subpart J—Medical Benefits and Vocational Rehabilitation daltland on DSKBBV9HB2PROD with RULES § 725.701 What medical benefits are available? (a) A miner who is determined to be eligible for benefits under this part or part 727 of this subchapter (see § 725.4(d)) is entitled to medical benefits as set forth in this subpart as of the date of his or her claim, but in no event before January 1, 1974. Medical benefits may not be provided to the survivor or dependent of a miner under this part. (b) A responsible operator, or where there is none, the fund, must furnish a miner entitled to benefits under this part with such medical services and treatments (including professional medical services and medical equipment, prescription drugs, outpatient medical services, inpatient medical services, and any other medical service, treatment or supply) for such periods as the nature of the miner’s pneumoconiosis and disability requires. (c) The medical benefits referred to in paragraphs (a) and (b) of this section include palliative measures useful only to prevent pain or discomfort associated with the miner’s pneumoconiosis or attendant disability. (d) An operator or the fund must also pay the miner’s reasonable cost of travel necessary for medical treatment (to be determined in accordance with prevailing United States government mileage rates) and the reasonable documented cost to the miner or medical provider incurred in communicating with the operator, carrier, or OWCP on matters connected with medical benefits. (e)(1) If a miner receives a medical service or treatment, as described in this section, for any pulmonary disorder, there will be a rebuttable presumption that the disorder is caused or aggravated by the miner’s pneumoconiosis. (2) The party liable for the payment of benefits may rebut the presumption by producing credible evidence that the medical service or treatment provided VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 was for a pulmonary disorder apart from those previously associated with the miner’s disability, or was beyond that necessary to effectively treat a covered disorder, or was not for a pulmonary disorder at all. (3) An operator or the fund, however, cannot rely on evidence that the miner does not have pneumoconiosis or is not totally disabled by pneumoconiosis arising out of coal mine employment to defeat a request for coverage of any medical service or treatment under this subpart. (4) In determining whether the treatment is compensable, the opinion of the miner’s treating physician may be entitled to controlling weight pursuant to § 718.104(d) of this subchapter. (5) A finding that a medical service or treatment is not covered under this subpart will not otherwise affect the miner’s entitlement to benefits. § 725.702 Who is considered a physician? The term ‘‘physician’’ includes only doctors of medicine (MD) and doctors of osteopathy (DO) within the scope of their practices as defined by State law. No treatment or medical services performed by any other practitioner of the healing arts is authorized by this part, unless such treatment or service is authorized and supervised both by a physician as defined in this section and by OWCP. § 725.703 How is treatment authorized? payment of benefits to a miner, OWCP will notify the operator or its insurance carrier of the names, addresses, and telephone numbers of the authorized providers of medical benefits chosen by an entitled miner, and require the operator or carrier to: (1) Notify the miner and the providers chosen that the operator or carrier will be responsible for the cost of medical services provided to the miner on account of the miner’s total disability due to pneumoconiosis; (2) Designate a person or persons with decision-making authority with whom OWCP, the miner and authorized providers may communicate on matters involving medical benefits provided under this subpart and notify OWCP, the miner and providers of this designation; (3) Make arrangements for the direct reimbursement of providers for their services. (b) Fund liability. If there is no operator found liable for the payment of benefits, OWCP will make necessary arrangements to provide medical care to the miner, notify the miner and providers selected of the liability of the fund, designate a person or persons with whom the miner or provider may communicate on matters relating to medical care, and make arrangements for the direct reimbursement of the medical provider. (a) Upon notification to a miner of such miner’s entitlement to benefits, OWCP must provide the miner with a list of authorized treating physicians and medical facilities in the area of the miner’s residence. The miner may select a physician from this list or may select another physician with approval of OWCP. Where emergency services are necessary and appropriate, authorization by OWCP is not required. (b) OWCP may, on its own initiative, or at the request of a responsible operator, order a change of physicians or facilities, but only where it has been determined that the change is desirable or necessary in the best interest of the miner. The miner may change physicians or facilities subject to the approval of OWCP. (c) If adequate treatment cannot be obtained in the area of the claimant’s residence, OWCP may authorize the use of physicians or medical facilities outside such area as well as reimbursement for travel expenses and overnight accommodations. § 725.705 Is prior authorization for medical services required? § 725.704 How are arrangements for medical care made? § 725.706 What reports must a medical provider give to OWCP? (a) Operator liability. If an operator has been determined liable for the (a) Within 30 days following the first medical or surgical treatment provided PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 (a) Except as provided in paragraph (b) of this section, medical services from an authorized provider which are payable under § 725.701 do not require prior approval of OWCP or the responsible operator. (b) Except where emergency treatment is required, prior approval of OWCP or the responsible operator must be obtained before any hospitalization or surgery, or before ordering medical equipment where the purchase price exceeds $300. A request for approval of non-emergency hospitalization or surgery must be acted upon expeditiously, and approval or disapproval will be given by telephone if a written response cannot be given within 7 days following the request. No employee of the Department of Labor, other than a district director or the Chief, Medical Audit and Operations Section, DCMWC, is authorized to approve a request for hospitalization or surgery by telephone. E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations under § 725.701, the provider must furnish to OWCP and the responsible operator or its insurance carrier, if any, a report of such treatment. (b) In order to permit continuing supervision of the medical care provided to the miner with respect to the necessity, character and sufficiency of any medical care furnished or to be furnished, the provider, operator or carrier must submit such reports in addition to those required by paragraph (a) of this section as OWCP may from time to time require. Within the discretion of OWCP, payment may be refused to any medical provider who fails to submit any report required by this section. daltland on DSKBBV9HB2PROD with RULES § 725.707 At what rate will fees for medical services and treatments be paid? (a) All fees charged by providers for any medical service, treatment, drug or equipment authorized under this subpart will be paid at no more than the rate prevailing for the service, treatment, drug or equipment in the community in which the provider is located. (b) When medical benefits are paid by the fund at OWCP’s direction, either on an interim basis or because there is no liable operator, the prevailing community rate for various types of service will be determined as provided in §§ 725.708–725.711. (c) The provisions of §§ 725.708– 725.711 do not apply to charges for medical services or treatments furnished by medical facilities of the U.S. Public Health Service or the Departments of the Army, Navy, Air Force and Veterans Affairs. (d) If the provisions of §§ 725.708– 725.711 cannot be used to determine the prevailing community rate for a particular service or treatment or for a particular provider, OWCP may determine the prevailing community rate by reliance on other federal or state payment formulas or on other evidence, as appropriate. (e) OWCP must review the payment formulas described in §§ 725.708– 725.711 at least once a year, and may adjust, revise or replace any payment formula or its components when necessary or appropriate to ensure miners’ access to care or for other reasons. (f) Except as otherwise provided in this subpart, the provisions of §§ 725.707–725.711 apply to all medical services and treatments rendered after August 31, 2018. § 725.708 How are payments for professional medical services and medical equipment determined? (a)(1) OWCP pays for professional medical services based on a fee VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 schedule derived from the schedule maintained by the Centers for Medicare & Medicaid Services (CMS) for the payment of such services under the Medicare program (42 CFR part 414). The schedule OWCP utilizes consists of: An assignment of Relative Value Units (RVU) to procedures identified by Healthcare Common Procedure Coding System/Current Procedural Terminology (HCPCS/CPT) code, which represents the work (relative time and intensity of the service), the practice expense and the malpractice expense, as compared to other procedures of the same general class; an assignment of Geographic Practice Cost Index (GPCI) values, which represent the relative work, practice expense and malpractice expense relative to other localities throughout the country; and a monetary value assignment (conversion factor) for one unit of value for each coded service. (2) The maximum payment for professional medical services identified by a HCPCS/CPT code is calculated by multiplying the RVU values for the service by the GPCI values for such service in that area and multiplying the sum of these values by the conversion factor to arrive at a dollar amount assigned to one unit in that category of service. (3) OWCP utilizes the RVUs published, and updated or revised from time to time, by CMS for all services for which CMS has made assignments. Where there are no RVUs assigned, OWCP may develop and assign any RVUs that OWCP considers appropriate. OWCP utilizes the GPCI for the locality as defined by CMS and as updated or revised by CMS from time to time. OWCP will devise conversion factors for professional medical services using OWCP’s processing experience and internal data. (b) Where a professional medical service is not covered by the fee schedule described in paragraph (a) of this section, OWCP may pay for the service based on other fee schedules or pricing formulas utilized by OWCP for professional medical services. (c) Paragraphs (a) and (b) of this section apply to professional medical services rendered after November 30, 2019. (d) OWCP pays for medical equipment identified by a HCPCS/CPT code based on fee schedules or other pricing formulas utilized by OWCP for such equipment. § 725.709 How are payments for prescription drugs determined? (a)(1) OWCP pays for drugs prescribed by physicians by multiplying a percentage of the average wholesale PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 27697 price, or other baseline price as specified by OWCP, of the medication by the quantity or amount provided, plus a dispensing fee. (2) All prescription medications identified by National Drug Code are assigned an average wholesale price representing the product’s nationally recognized wholesale price as determined by surveys of manufacturers and wholesalers, or another baseline price designated by OWCP. (3) OWCP may establish the dispensing fee. (b) If the pricing formula described in paragraph (a) of this section is inapplicable, OWCP may make payment based on other pricing formulas utilized by OWCP for prescription medications. (c) OWCP may, in its discretion, contract for or require the use of specific providers for certain medications. OWCP also may require the use of generic equivalents of prescribed medications where they are available. § 725.710 How are payments for outpatient medical services determined? (a)(1) Except as provided in paragraphs (b) and (c) of this section, OWCP pays for outpatient medical services according to Ambulatory Payment Classifications (APCs) derived from the Outpatient Prospective Payment System (OPPS) devised by the Centers for Medicare & Medicaid Services (CMS) for the Medicare program (42 CFR part 419). (2) For outpatient medical services paid under the OPPS, such services are assigned according to the APC prescribed by CMS for that service. Each payment is derived by multiplying the prospectively established scaled relative weight for the service’s clinical APC by a conversion factor to arrive at a national unadjusted payment rate for the APC. The labor portion of the national unadjusted payment rate is further adjusted by the hospital wage index for the area where payment is being made. Additional adjustments are also made as required or needed. (b) If a compensable service cannot be assigned or paid at the prevailing community rate under the OPPS or occurs at a facility excluded from the Medicare OPPS, OWCP may pay for the service based on fee schedules or other pricing formulas utilized by OWCP for outpatient services. (c) This section does not apply to services provided by ambulatory surgical centers. (d) This section applies to outpatient medical services rendered after November 30, 2019. E:\FR\FM\14JNR1.SGM 14JNR1 27698 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations § 725.711 How are payments for inpatient medical services determined? (a)(1) OWCP pays for inpatient medical services according to predetermined rates derived from the Medicare Inpatient Prospective Payment System (IPPS) used by the Centers for Medicare & Medicaid Services (CMS) for the Medicare program (42 CFR part 412). (2) Inpatient hospital discharges are classified into diagnosis-related groups (DRGs). Each DRG groups together clinically similar conditions that require comparable amounts of inpatient resources. For each DRG, an appropriate weighting factor is assigned that reflects the estimated relative cost of hospital resources used with respect to discharges classified within that group compared to discharges classified within other groups. (3) For each hospital discharge classified within a DRG, a payment amount for that discharge is determined by using the national weighting factor determined for that DRG, national standardized adjustments, and other factors which may vary by hospital, such as an adjustment for area wage levels. OWCP may also use other price adjustment factors as appropriate based on its processing experience and internal data. (b) If an inpatient service cannot be classified by DRG, occurs at a facility excluded from the Medicare IPPS, or otherwise cannot be paid at the prevailing community rate under the pricing formula described in paragraph (a) of this section, OWCP may pay for the service based on fee schedules or other pricing formulas utilized by OWCP for inpatient services. daltland on DSKBBV9HB2PROD with RULES § 725.712 When and how are fees reduced? (a) A provider’s designation of the code used to identify a billed service or treatment will be accepted if the code is consistent with the medical and other evidence, and the provider will be paid no more than the maximum allowable fee for that service or treatment. If the code is not consistent with the medical evidence or where no code is supplied, the bill will be returned to the provider for correction and resubmission or denied. (b) If the charge submitted for a service or treatment supplied to a miner exceeds the maximum amount determined to be reasonable under this subpart, OWCP must pay the amount allowed by §§ 725.707–725.711 for that service and notify the provider in writing that payment was reduced for that service in accordance with those provisions. VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 (c) A provider or other party who disagrees with a fee determination may seek review of that determination as provided in this subpart (see § 725.718). § 725.713 If a fee is reduced, may a provider bill the claimant for the balance? Where a provider submits a bill to OWCP and OWCP has reduced the provider’s fee, the miner is not responsible for any additional payment for services or treatments covered under this subpart. Thus, a provider whose fee for service is partially paid by OWCP as a result of the application of the provisions of §§ 725.707–725.711 or otherwise in accordance with this subpart may not request reimbursement from the miner for additional amounts. § 725.714 How do providers enroll with OWCP for authorizations and billing? (a) All non-pharmacy providers seeking payment from the fund must enroll with OWCP or its designated bill processing agent to have access to the automated authorization system and to submit medical bills to OWCP. (b) To enroll, the non-pharmacy provider must complete and submit a Form OWCP–1168 to the appropriate location noted on that form. By completing and submitting this form, providers certify that they satisfy all applicable Federal and State licensure and regulatory requirements that apply to their specific provider or supplier type. (c) The non-pharmacy provider must maintain documentary evidence indicating that it satisfies those requirements. (d) The non-pharmacy provider must also notify OWCP immediately if any information provided to OWCP in the enrollment process changes. (e) All pharmacy providers must obtain a National Council for Prescription Drug Programs number. Upon obtaining such number, they are automatically enrolled in OWCP’s pharmacy billing system. (f) After enrollment, a provider must submit all medical bills to OWCP through its bill processing portal or to the OWCP address specified for such purpose and must include the Provider Number/ID obtained through enrollment, or its National Provider Number (NPI) or any other identifying numbers required by OWCP. § 725.715 How do providers submit medical bills? (a) A provider must itemize charges on Form OWCP–1500 or CMS–1500 (for professional services, equipment or drugs dispensed in the office), Form OWCP–04 or UB–04 (for hospitals), an electronic or paper-based bill that PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 includes required data elements (for pharmacies) or other form as designated by OWCP, and submit the form promptly to OWCP. (b) The provider must identify each medical service performed using the Current Procedural Terminology (CPT) code, the Healthcare Common Procedure Coding System (HCPCS) code, the National Drug Code (NDC) number, or the Revenue Center Code (RCC), as appropriate to the type of service. OWCP has discretion to determine which of these codes may be utilized in the billing process. OWCP also has the authority to create and supply codes for specific services or treatments. These OWCP-created codes will be issued to providers by OWCP as appropriate and may only be used as authorized by OWCP. A provider may not use an OWCP-created code for other types of medical examinations, services or treatments. (1) For professional medical services, the provider must list each diagnosed condition in order of priority and furnish the corresponding diagnostic code using the ‘‘International Classification of Disease, 10th Edition, Clinical Modification’’ (ICD–10–CM), or as revised. (2) For prescription drugs or supplies, the provider must include the NDC assigned to the product, and such other information as OWCP may require. (3) For outpatient medical services, the provider must use HCPCS codes and other coding schemes in accordance with the Outpatient Prospective Payment System. (4) For inpatient medical services, the provider must include admission and discharge summaries and an itemized statement of the charges. (c)(1) By submitting a bill or accepting payment, the provider signifies that the service for which reimbursement is sought was performed as described, necessary, appropriate, and properly billed in accordance with accepted industry standards. For example, accepted industry standards preclude upcoding billed services for extended medical appointments when the miner actually had a brief routine appointment, or charging for the services of a professional when a paraprofessional or aide performed the service; industry standards prohibit unbundling services to charge separately for services that should be billed as a single charge. (2) The provider agrees to comply with all regulations set forth in this subpart concerning the provision of medical services or treatments and/or the process for seeking reimbursement for medical services and treatments, E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations § 725.717 What are the time limitations for requesting payment or reimbursement for covered medical services or treatments? § 725.716 How should a miner prepare and submit requests for reimbursement for covered medical expenses and transportation costs? daltland on DSKBBV9HB2PROD with RULES including the limitation imposed on the amount to be paid. OWCP will pay providers and reimburse miners promptly for all bills received on an approved form and in a timely manner. However, absent good cause, no bill will be paid for expenses incurred if the bill is submitted more than one year beyond the end of the calendar year in which the expense was incurred or the service or supply was provided, or more than one year beyond the end of the calendar year in which the miner’s eligibility for benefits is finally adjudicated, whichever is later. A provider may not request reimbursement from a miner for a bill denied by OWCP due to late submission of the bill by the provider. (a) If a miner has paid bills for a medical service or treatment covered under § 725.701 and seeks reimbursement for those expenses, he or she may submit a request for reimbursement on Form OWCP–915, together with an itemized bill. The reimbursement request must be accompanied by evidence that the provider received payment for the service from the miner and a statement of the amount paid. Acceptable evidence that payment was received includes, but is not limited to, a copy of the miner’s canceled check (both front and back) or a copy of the miner’s credit card receipt. (b) OWCP may waive the requirements of paragraph (a) of this section if extensive delays in the filing or the adjudication of a claim make it unusually difficult for the miner to obtain the required information. (c) Reimbursements for covered medical services paid by a miner generally will be no greater than the maximum allowable charge for such service as determined under §§ 725.707–725.711. (d) A miner will be only partially reimbursed for a covered medical service if the amount he or she paid to a provider for the service exceeds the maximum charge allowable. If this happens, OWCP will advise the miner of the maximum allowable charge for the service in question and of his or her responsibility to ask the provider to refund to the miner, or credit to the miner’s account, the amount he or she paid which exceeds the maximum allowable charge. (e) If the provider does not refund to the miner or credit to his or her account the amount of money paid in excess of the charge allowed by OWCP, the miner should submit documentation to OWCP of the attempt to obtain such refund or credit. OWCP may make reasonable reimbursement to the miner after reviewing the facts and circumstances of the case. (f) If a miner has paid transportation costs or other incidental expenses related to covered medical services under this part, the miner may submit a request for reimbursement on Form OWCP–957 or OWCP–915, together with proof of payment. VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 § 725.718 How are disputes concerning medical benefits resolved? (a) If a dispute develops concerning medical services or treatments or their payment under this part, OWCP must attempt to informally resolve the dispute. OWCP may, on its own initiative or at the request of the responsible operator or its insurance carrier, order the claimant to submit to an examination by a physician selected by OWCP. (b) If a dispute cannot be resolved informally, OWCP will refer the case to the Office of Administrative Law Judges for a hearing in accordance with this part. Any such hearing concerning authorization of medical services or treatments must be scheduled at the earliest possible time and must take precedence over all other hearing requests except for other requests under this section and as provided by § 727.405 of this subchapter (see § 725.4(d)). During the pendency of such adjudication, OWCP may order the payment of medical benefits prior to final adjudication under the same conditions applicable to benefits awarded under § 725.522. (c) In the development or adjudication of a dispute over medical benefits, the adjudication officer is authorized to take whatever action may be necessary to protect the health of a totally disabled miner. (d) Any interested medical provider may, if appropriate, be made a party to a dispute under this subpart. § 725.719 What is the objective of vocational rehabilitation? The objective of vocational rehabilitation is the return of a miner who is totally disabled by pneumoconiosis to gainful employment commensurate with such miner’s physical impairment. This objective PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 27699 may be achieved through a program of re-evaluation and redirection of the miner’s abilities, or retraining in another occupation, and selective job placement assistance. § 725.720 How does a miner request vocational rehabilitation assistance? Each miner who has been determined entitled to receive benefits under part C of title IV of the Act must be informed by OWCP of the availability and advisability of vocational rehabilitation services. If such miner chooses to avail himself or herself of vocational rehabilitation, his or her request will be processed and referred by OWCP vocational rehabilitation advisors pursuant to the provisions of §§ 702.501 through 702.508 of this chapter as is appropriate. Dated: June 5, 2018. Julia K. Hearthway, Director, Office of Workers’ Compensation Programs. [FR Doc. 2018–12418 Filed 6–13–18; 8:45 am] BILLING CODE 4510–CR–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA–2018–N–1928] Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA or we) is classifying the brain trauma assessment test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain trauma assessment test’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. DATES: This order is effective June 14, 2018. The classification was applicable on February 14, 2018. FOR FURTHER INFORMATION CONTACT: Erin Cutts, Center for Devices and Radiological Health, Food and Drug SUMMARY: E:\FR\FM\14JNR1.SGM 14JNR1

Agencies

[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Rules and Regulations]
[Pages 27690-27699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12418]


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DEPARTMENT OF LABOR

Office of Workers' Compensation Programs

20 CFR Part 725

RIN 1240-AA11


Black Lung Benefits Act: Medical Benefit Payments

AGENCY: Office of Workers' Compensation Programs, Labor.

ACTION: Final rule.

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SUMMARY: This final rule revises the regulations under the Black Lung 
Benefits Act (BLBA or Act) governing the payment of medical benefits 
and maintains the level of care available to miners. The final rule 
establishes methods for determining the amounts that the Black Lung 
Disability Trust Fund (Trust Fund) will pay for covered medical 
services and treatments provided to entitled miners. The Department 
based the rule on payment formulas that the Centers for Medicare & 
Medicaid Services (CMS) uses to determine payments under the Medicare 
program, which are similar to the formulas used by other programs that 
the Office of Workers' Compensation Programs (OWCP) administers. The 
Department is adopting these payment formulas for the black lung 
program because they more accurately reflect prevailing community rates 
for authorized treatments and services than do the internally-derived 
payment formulas that OWCP currently uses. In addition, the final rule 
eliminates two obsolete provisions.

DATES: 
    Effective Date: This rule is effective August 31, 2018.
    Applicability Dates: Sections 725.708(d), 725.709, and 725.711 
apply to medical equipment, prescription drugs, and inpatient medical 
services provided or rendered after August 31, 2018. Sections 
725.708(a) and (b) and 725.710 apply to professional medical services 
and outpatient medical services rendered after November 30, 2019.

FOR FURTHER INFORMATION CONTACT: Michael A. Chance, Director, Division 
of Coal Mine Workers' Compensation, Office of Workers' Compensation 
Programs, U.S. Department of Labor, 200 Constitution Avenue NW, Suite 
N-3520, Washington, DC 20210. Telephone: 1-800-347-2502. This is a 
toll-free number. TTY/TDD callers may dial toll-free 1-800-877-8339 for 
further information.

SUPPLEMENTARY INFORMATION:

I. Background of This Rulemaking

    The BLBA, 30 U.S.C. 901-944, provides for the payment of benefits 
to coal miners and certain of their dependent survivors on account of 
total disability or death due to coal workers' pneumoconiosis. 30 
U.S.C. 901(a); Usery v. Turner Elkhorn Min. Co., 428 U.S. 1, 5 (1976). 
A miner who is entitled to disability benefits under the BLBA is also 
entitled to medical benefits. 33 U.S.C. 907, as incorporated by 30 
U.S.C. 932(a); 20 CFR 725.701. Those medical benefits entitle a miner 
to medical, surgical, and other treatment--including hospital services, 
medicine, equipment, and supplies--for his or her pneumoconiosis and 
related disability. 20 CFR 725.701(b). The rules governing the payment 
of medical benefits are contained in 20 CFR part 725, subpart J.
    Benefits are paid by either a ``responsible'' coal mine operator 
(or its insurance carrier), or the Trust Fund. Director, OWCP v. 
Bivens, 757 F.2d 781, 783 (6th Cir. 1985); see 20 CFR 725.495 (criteria 
for determining a responsible operator). OWCP pays medical benefits 
from the Trust Fund in three instances: (1) If no responsible operator 
can be identified as the party liable for a claim, and the Trust Fund 
is liable as a result (see 20 CFR 725.701(b)); (2) when the identified 
responsible operator declines to pay benefits pending final 
adjudication of a claim (see 20 CFR 725.522, 725.708(b)); and (3) when 
the responsible operator fails to meet its payment obligations on an 
effective award (see 20 CFR 725.502). For interim payments made pending 
final adjudication, OWCP seeks reimbursement from the operator after 
the claim is finally awarded. 20 CFR 725.602(a). Likewise, OWCP seeks 
reimbursement for payments made when an operator fails to meet its 
obligations on an effective award. 20 CFR 725.601.
    Although the current regulations provide that medical services and 
supplies be paid at the rate prevailing in the community where the 
physician, medical facility or supplier is located, they do not address 
how the prevailing community rate should be determined. See 20 CFR 
725.706(c). OWCP currently bases Trust Fund payments for professional 
medical services, medical equipment, and inpatient and outpatient 
medical services and treatments on internally-derived payment formulas. 
For prescription medications, OWCP uses a payment formula similar to 
that employed by the three other workers' compensation programs that it 
administers.
    On January 4, 2017, the Department issued a Notice of Proposed 
Rulemaking (NPRM), proposing a revised Subpart J. 82 FR 739-770 (Jan. 
4, 2017). Specifically, the Department proposed to base Trust Fund 
payments for all medical services and treatments rendered on or after 
the effective date of the rule on payment formulas derived from those 
used by CMS under the Medicare program. Id. at 740. The proposed 
payment formulas were similar to those used by other OWCP programs, but 
were tailored to the specific geography, medical conditions, and needs 
of black lung program stakeholders. See id. at 767 (proposed Sec.  
725.707).
    The Department chose these payment formulas for several reasons. 
The proposed formulas more accurately reflected prevailing community 
rates for authorized treatments and services than did OWCP's 
internally-derived formulas. Id. at 740. In addition,

[[Page 27691]]

because responsible operators and their insurance carriers utilize 
payment formulas or fee schedules that are substantially similar to the 
proposed payment formulas, use of such formulas would more likely lead 
operators to reimburse fully the Trust Fund for the payments the Trust 
Fund makes on an interim basis. Id. Thus, the proposed rule would 
control the health care costs associated with the BLBA, conserve the 
Trust Fund's limited resources, and provide greater clarity and 
certainty with respect both to fees paid to providers and 
reimbursements sought from operators and carriers. The rule would also 
ensure more consistent payment policies across all of the programs 
administered by OWCP. Id.
    The public comment period closed on March 6, 2017. The Department 
has fully evaluated these comments and has determined that proceeding 
with a final rule is in the best interests of the stakeholders and the 
program's administration.

II. Statutory Authority

    Section 426(a) of the BLBA, 30 U.S.C. 936(a), authorizes the 
Secretary of Labor to prescribe rules and regulations necessary for the 
administration and enforcement of the BLBA. The Secretary is also 
explicitly empowered to promulgate regulations addressing medical fees 
and charges, including determining the prevailing community rate. 33 
U.S.C. 907(g), as incorporated by 30 U.S.C. 932(a).

III. Discussion of Significant Comments

    The Department received eleven comments on the proposed 
regulations. Most of these comments focus on a few substantive issues. 
Some commenters generally supported OWCP's efforts to modernize the 
medical payment formulas and no commenters expressed overall objections 
to the promulgation of these rules. Several commenters applauded the 
technical changes made to several rules to simplify and clarify the 
language, such as replacing the term ``Office'' with ``OWCP.'' No 
negative comments were received on the following revised or new 
regulations: Sec. Sec.  725.308, 725.701, 725.702, 725.703, 725.704, 
725.706, 725.708, 725.711, 725.712, and 725.714-725.720. Thus, the 
Department is promulgating these regulations as proposed. The 
Department received one negative comment on the substantive provisions 
of Sec.  725.705 (titled ``Is prior authorization for medical services 
required?''), but the Department proposed only technical changes to 
this rule and did not open it for substantive comment. Thus, the 
Department is promulgating Sec.  725.705 as proposed.
    In addition to comments received on specific sections of the 
proposed rules (discussed below in the Section-by-Section Explanation), 
a few commenters offered more general comments. One suggested that the 
medical bill payment rules should contain provisions allowing the 
Director to sue operators who fail to properly reimburse the Trust Fund 
for medical benefit payments made on their behalf. The BLBA 
incorporates various provisions of the and Harbor Workers' Compensation 
Act, 33 U.S.C. 918(a), 921(d), as incorporated by 30 U.S.C. 932(a), 
that already provide the Department with authority to undertake such 
suits. See generally 20 CFR 725.601-725.605 (regulations implementing 
enforcement of liability against operators). The implementing 
regulations clarify that these enforcement tools may be used when an 
operator fails to reimburse the Trust Fund for medical benefits. 20 CFR 
725.602(a). Thus, the Department does not believe that any additional 
authority is necessary.
    Another commenter requested that the Department specify when OWCP 
will exercise its discretion to modify or change payment formulas or 
parts thereof as provided in several proposed regulations. See proposed 
Sec. Sec.  725.707, 725.708, 725.709, 725. 710, 725.711. The vast 
majority of payments for medical services and treatments will be 
determined under the payment formulas set out in these regulations. The 
provisions giving OWCP discretion to modify or change payment formulas 
are intended to allow OWCP to respond quickly to unique or novel 
medical, technological, or financial circumstances that arise in 
implementing the payment formulas both initially and over time. The 
Department cannot predict when that might occur, and thus cannot 
specify when OWCP would take such discretionary actions.
    Finally, the Department has determined that a two-phase 
implementation of this rule will be more efficient and cost-effective, 
allow sufficient time to update and improve its computer processes, and 
result in less disruption, than implementing the entire rule at once. 
Except for Sec. Sec.  725.708(a) and (b) and 725.710, all provisions of 
this rule (including the payment formulas for medical equipment, 
prescription drugs and inpatient medical services) will apply to 
services and treatments rendered after the effective date of the rule, 
August 31, 2018. The Department can apply these regulations immediately 
because they either codify existing practices or require easily 
implemented modifications to current payment processes. The provisions 
of Sec. Sec.  725.708(a) and (b) and 725.710 (governing the payment of 
professional medical services and outpatient medical services) will 
apply to services and treatments rendered after November 30, 2019. Both 
regulations would require extensive modifications to the existing 
computer processes for full implementation. The Department is currently 
transitioning to a new computer system and will realize cost-savings by 
building the new payment methodologies into that system rather than 
modifying the existing one. The Department has revised three provisions 
(Sec. Sec.  725.707, 725.708 and 725.710) to reflect the two-phase 
implementation. The changes to each provision are discussed in the 
Section-by-Section Explanation.

Section-by-Section Explanation

20 CFR 725.707 At what rate will fees for medical services and 
treatments be paid?
    (a) Section 725.707 is a new provision that sets out general rules 
governing the payment of compensable medical bills by the Trust Fund. 
It provides that the Trust Fund will pay no more than the prevailing 
community rate for medical services, treatments, drugs or equipment, 
and that the prevailing community rate for various types of treatments 
and services will generally be determined under the provisions of 
Sec. Sec.  725.708-725.711. Where the provisions of Sec. Sec.  725.708-
725.711 cannot be used to determine the prevailing community rate, the 
rule permits OWCP to determine the prevailing community rate based on 
other payment formulas or evidence. This section also requires OWCP to 
review the payment formulas in Sec. Sec.  725.708-725.711 annually, and 
permits OWCP to adjust, revise or replace any formula (or its 
components) when needed.
    (b) Four commenters express concern that the proposed payment 
formulas may have a negative impact on miners' access to care. This 
concern stems from the fact that reduced payments will result in some 
circumstances under the proposed rules. One commenter believes that 
rural Appalachia would feel the greatest impact.
    The Department agrees that maintaining miners' access to care is of 
paramount importance in implementing the payment formulas for various 
services and treatments. In fact, OWCP made access to care a primary

[[Page 27692]]

consideration during the development of the proposed rules. Although 
the text of proposed Sec.  725.707 does not directly address impact on 
access to care, the NPRM's preamble makes repeated reference to this 
concern and expresses OWCP's intent to continually review the payment 
formulas to ensure that they do not adversely impact access to care. In 
particular, the rule requires OWCP to review the payment formulas at 
least annually and revise them if needed, Sec.  725.707(e), and the 
preamble to this provision makes clear that it is intended to allow 
OWCP to quickly make changes to the formulas if they ``are adversely 
impacting miners' access to care, or are otherwise not appropriate.'' 
82 FR 742; see also id. at 740, 746, 748, 749, 752. These changes could 
include adjustments for particular geographic areas.
    Nonetheless, the commenters' general concern is important and the 
Department agrees that maintaining access to care should be codified in 
the regulation. Thus, the Department has revised Sec.  725.707(e) in 
the final rule to specifically require that OWCP consider and ensure 
miners' access to care in its annual review of the payment formulas in 
Sec. Sec.  725.708-.725.711. The Department believes that this 
clarification of its intent will prevent miners' access to care from 
being negatively affected by the new payment formulas.
    (c) Finally, the Department has revised Sec.  725.707(f) to reflect 
the phased implementation of this rule. This paragraph now provides 
that the provisions of the rule apply to all medical services or 
treatments rendered after the effective date of the rule (August 31, 
2018), except as otherwise noted in the rule. A different application 
date for the payment formulas for professional medical services and 
outpatient medical services is now provided in Sec. Sec.  725.708 and 
725.710. These regulations apply to services and treatments rendered 
after November 30, 2019.
20 CFR 725.708 How are payments for professional medical services and 
medical equipment determined?
    Section 725.708 is a new provision governing payment for 
professional medical services and medical equipment. No comments were 
received on this provision. The Department, however, has revised the 
provision to reflect the phased implementation of this rule. The 
Department has added a new paragraph (c), which states that the 
provisions of paragraphs (a) and (b) apply to professional medical 
services rendered after November 30, 2019. This later applicability 
date does not apply to payments for medical equipment, which are 
instead governed by the general applicability date in Sec.  725.707(f). 
The Department has also renumbered paragraph (c) of the proposed rule 
(dealing with payment for medical equipment) as paragraph (d).
20 CFR 725.709 How are payments for prescription drugs determined?
    (a) Section 725.709 is a new provision governing payment for 
compensable prescription drugs. The regulation codifies existing policy 
and does not change current payment practice. It is also consistent 
with the payment practices of the other programs that OWCP administers. 
Section 725.709 generally provides for payment for prescribed 
medication at a percentage of the national average wholesale price (or 
another baseline price designated by OWCP) for a particular medication, 
plus a flat-rate dispensing fee. It also provides that OWCP may, in its 
discretion, require the use of specific providers for certain 
medications.
    (b) One commenter asks OWCP to specify when miners will be required 
to use specific providers for certain medications. The comment also 
requests clarification of whether OWCP will directly negotiate with 
drug manufacturers, presumably with respect to the cost of medications.
    The Department declines to revise the regulation in response to 
this comment. OWCP does not currently require the use of specific 
providers for any medication under the BLBA. The provision in Sec.  
725.709 gives OWCP the option of doing so in the future if it would be 
in the best interests of both the agency and the program's 
stakeholders. It is not possible to predict or specify when OWCP might 
use this option. OWCP, however, would advise miners and providers 
before any such requirement were implemented. With respect to 
negotiating drug prices with drug manufacturers, OWCP is a third-party 
payer and does not directly purchase medications or distribute them to 
miners.
20 CFR 725.710 How are payments for outpatient medical services 
determined?
    (a) Section 725.710 is a new provision governing payment for 
compensable outpatient medical services. As proposed, it provides that, 
where appropriate, OWCP will utilize the Outpatient Prospective Payment 
System (OPPS) devised by CMS for the Medicare program. The proposed 
rule also states that where outpatient services cannot be assigned or 
priced appropriately under the OPPS system, payment will be based on 
fee schedules and other pricing formulas utilized by OWCP.
    (b) One commenter requested clarification of the proposed rules 
with respect to payments that would be made to Critical Access 
Hospitals (CAHs) for outpatient hospital services. CAHs are small 
hospitals (generally 25 beds or less) in isolated rural areas (35 miles 
or more from another hospital, 15 or more miles in mountainous areas) 
that provide emergency services and offer short-term (generally less 
than 96 hours) inpatient services. See 42 U.S.C. 1395i-4, 1395x; 42 CFR 
485.601-485.647. Medicare uses different payment formulas for services 
and treatments at CAHs than those used to pay other hospitals. In 
particular, Medicare excludes CAHs from both its inpatient and 
outpatient prospective payment systems. The commenter notes that under 
proposed Sec.  725.711 (inpatient hospital services), services at 
facilities (such as CAHs) that are excluded from Medicare's Inpatient 
Prospective Payment System will be paid under fee schedules or other 
pricing formulas. The commenter requests clarification of whether a 
similar policy will be applied for outpatient services, given that CAHs 
are excluded from Medicare's OPPS. The commenter also requests that the 
Department consider undertaking additional economic analysis of 
applying the OPPS to CAHs.
    During the development of the proposed rules, OWCP determined that 
CAHs would be exempt from the new outpatient and inpatient prospective 
payment systems generally applicable to other hospitals, as CAHs are 
excluded from Medicare's prospective payment systems. While this 
determination was codified in the inpatient regulation (Sec.  725.711), 
it was omitted from the outpatient regulation (Sec.  725.710). The 
Department agrees with the commenter that Sec.  725.710 should be 
revised to clarify that the outpatient payment formula described in 
paragraph (a) of the provision does not apply to services at facilities 
(such CAHs) that are excluded from Medicare's OPPS. Thus, the 
Department has revised Sec.  725.710(b) in the final rule to provide 
that services at such facilities will be paid ``based on fee schedules 
or other pricing formulas utilized by OWCP for outpatient services.'' 
This revision mirrors the inpatient rule and is consistent with 
Medicare's exclusion of CAHs from its OPPS. Since the Department has 
revised Sec.  725.710 to exclude CAHs from the general payment formula, 
there is no need to analyze the economic impact of that formula on 
CAHs.
    (c) Finally, the Department has revised Sec.  725.710 to reflect 
the phased

[[Page 27693]]

implementation of this rule. The Department has added a new paragraph 
(d), which states that the provisions of this section apply to 
outpatient medical services rendered after November 30, 2019.
20 CFR 725.713 If a fee is reduced, may a provider bill the claimant 
for the balance?
    (a) Section 725.713 is a new provision addressing reductions in 
requested fees. The proposed regulation provides that if a billed fee 
has been reduced (i.e., only paid in part) in accordance with the 
provisions of Subpart J, providers may not recover any additional 
amount from the miner. It, thus, prohibits the practice of ``balance 
billing,'' which occurs when providers receive only a portion of their 
submitted charges from third-party payers and seek to recover the 
``balance'' from the patient.
    (b) Three commenters request that the proposed rule be extended to 
prohibit balance billing where OWCP makes no payment for a treatment or 
service, as well as where the agency makes partial payment. The 
commenters also request that the principle that disabled miners and 
their families should never have to make any payments for covered 
treatments and services under the BLBA be explicitly stated in the 
rule.
    It is OWCP's longstanding position and practice that miners should 
not be subject to balance billing for treatments and services that are 
covered under these regulations. To make this clear, the Department has 
revised Sec.  725.713 in the final rule to explicitly state that 
providers cannot bill miners for, and that miners are not required to 
pay, any remaining balance for any treatments or services provided 
pursuant to this subpart (i.e., that are for a miner's disabling 
pneumoconiosis) after OWCP makes partial payment for such treatments 
and services. See also discussion at Sec.  725.717 (noting similar 
revision). OWCP, however, has no legal authority to pay bills for 
services or treatments not covered under the BLBA (i.e., that are 
unrelated to a miner's disabling pneumoconiosis), or to regulate the 
payment and collection of such bills. Thus, the Department declines to 
extend Sec.  725.713 to situations where OWCP denies payment entirely 
for noncovered services or treatments.
Sec.  725.717 What are the time limitations for requesting payment or 
reimbursement for covered medical services or treatments?
    (a) Section 725.717 is a new provision setting time limits on the 
submission of bills by providers and reimbursement requests by miners. 
Bills and reimbursement requests must be submitted within one year of 
either (1) the end of the calendar year in which the service or 
treatment was provided or (2) the end of the calendar year in which the 
miner's entitlement to benefits was finally adjudicated, whichever is 
later. OWCP may waive these time limits for good cause shown.
    (b) As discussed under Sec.  725.713, several commenters asked the 
Department to clarify in the regulations that miners are not required 
to pay for covered treatments and services. The Department agrees with 
the commenters' point. Thus, in addition to revising Sec.  725.713, the 
Department has revised the title and text of Sec.  725.717 to clarify 
that a provider may not seek reimbursement from a miner when OWCP 
denies an otherwise-compensable bill due to late submission.

IV. Information Collection Requirements (Subject to the Paperwork 
Reduction Act) Imposed Under the Proposed Rule

    The Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., 
and its implementing regulations, 5 CFR part 1320, require that the 
Department consider the impact of paperwork and other information 
collection burdens imposed on the public. A federal agency generally 
cannot conduct or sponsor a collection of information, and the public 
is generally not required to respond to an information collection, 
unless it is approved by the Office of Management and Budget (OMB) 
under the PRA and displays a current, valid OMB Control Number. In 
addition, no person may generally be subject to penalty for failing to 
comply with an information collection that does not display a valid 
Control Number. See 5 CFR 1320.5(a) and 1320.6.
    Although the medical benefit payment rules in Subpart J contain 
collections of information within the meaning of the PRA (see 
Sec. Sec.  725.715-725.716), these collections are not new. They are 
currently approved for use in the black lung program and other OWCP-
administered compensation programs by OMB under Control Numbers 1240-
0007 (OWCP-915 Claim for Medical Reimbursement); 1240-0019 (OWCP-04 
Uniform Billing Form); 1240-0021 (OWCP-1168 Provider Enrollment Form); 
1240-0037 (OWCP-957 Medical Travel Refund Request); and 1240-0044 
(OWCP-1500 Health Insurance Claim Form). The requirements for 
completion of the forms and the information collected on the forms do 
not change under this rule. Since no changes are being made to the 
collections, the overall burdens imposed by them also will not change.
    While the Department has determined that the rule does not affect 
the general terms of the information collections or their associated 
burdens, consistent with requirements codified at 44 U.S.C. 
3506(a)(1)(B), (c)(2)(B) and 3507(a)(1)(D); 5 CFR 1320.11, the 
Department submitted a series of Information Collection Requests (ICRs) 
to OMB for approval concurrent with the NPRM to update the information 
collections to reflect this rulemaking and provide interested parties a 
specific opportunity to comment under the PRA. The NPRM specifically 
invited comments regarding the information collection and notified the 
public of their opportunity to file such comments with both OMB and the 
Department. 82 FR 742. On March 6, 2017, OMB concluded its review of 
the ICRs by asking the Department to submit updated ICRs at the final 
rule stage after considering any public comments regarding the 
information collection requirements in the rule. While the Department 
received comments on the substance of the proposed rule, which are 
addressed in the Section-by-Section Explanation above, it received no 
comments about the information collection burdens.
    The Department submitted updated ICRs to OMB for the information 
collections in this final rule. See ICR Reference Numbers 1240-0007: 
201805-1240-0006; 1240-0019: 201805-1240-0005; 1240-0021: 201805-1240-
0004; 1240-0037: 201805-1240-0003; and 1240-0044: 201805-1240-0002. A 
copy of these requests (including supporting documentation) may be 
obtained free of charge from the Reginfo.gov website at www.Reginfo.gov 
or by contacting Michael A. Chance, Director, Division of Coal Mine 
Workers' Compensation, Office of Workers' Compensation Programs, U.S. 
Department of Labor, 200 Constitution Avenue NW, Suite N-3464, 
Washington, DC 20210. Telephone: (202) 693-0978 (this is not a toll-
free number). TTY/TDD callers may dial toll-free 1-800-877-8339. 
Concurrent with its approval of this rule, OMB also approved the 
updated ICRs.
    The information collections in this rule are summarized as follows. 
The number of responses and burden estimates listed are not specific to 
the black lung program; instead, the estimates are cumulative for all 
OWCP-administered compensation programs that collect this information.

[[Page 27694]]

    1. Title of Collection: Claim for Medical Reimbursement Form (OWCP-
915).
    OMB Control Number: 1240-0007.
    Total Estimated Number of Responses: 34,564.
    Total Estimated Annual Time Burden: 5,738 hours.
    Total Estimated Annual Other Costs Burden: $59,450.
    2. Title of Collection: Uniform Billing Form (OWCP-04).
    OMB Control Number: 1240-0019.
    Total Estimated Number of Responses: 259,865.
    Total Estimated Annual Time Burden: 29,466 hours.
    Total Estimated Annual Other Costs Burden: $0.
    3. Title of Collection: Provider Enrollment Form (OWCP-1168).
    OMB Control Number: 1240-0021.
    Total Estimated Number of Responses: 64,325.
    Total Estimated Annual Time Burden: 8,555 hours.
    Total Estimated Annual Other Costs Burden: $33,449.
    4. Title of Collection: Medical Travel Refund Request (OWCP-957).
    OMB Control Number: 1240-0037.
    Total Estimated Number of Responses: 333,528.
    Total Estimated Annual Time Burden: 55,366 hours.
    Total Estimated Annual Other Costs Burden: $173,435.
    5. Title of Collection: Health Insurance Claim Form (OWCP-1500).
    OMB Control Number: 1240-0044.
    Total Estimated Number of Responses: 3,381,232.
    Total Estimated Annual Time Burden: 321,455 hours.
    Total Estimated Annual Other Costs Burden: $0.

V. Executive Orders 12866 and 13563 (Regulatory Planning and Review)

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. It also instructs agencies to review ``rules that may be 
outmoded, ineffective, insufficient, or excessively burdensome, and to 
modify, streamline, expand, or repeal them.'' The Department has 
considered the final rule with these principles in mind and has 
determined that the regulated community will benefit from this 
regulation.
    The Department addressed these issues in the NPRM. 82 FR 745-752. 
The Department comprehensively analyzed the potential economic impact 
of the new payment formulas and determined that they would not have a 
significant impact on either the economy as a whole or on firms that 
provide black lung-related health care to entitled miners. 82 FR 745-
751. Comparing Trust Fund medical benefit payments for Fiscal Year 2014 
with payment amounts that would be made under the proposed regulations 
for the same services, the Department estimated an aggregate $3,154,297 
annual reduction in Trust Fund payments under the proposed payment 
formulas. 82 FR 751. Further analysis revealed that even for negatively 
affected providers, the proposed rule would not have significant impact 
on individual firms. Id.
    The Department also noted the rule's multiple advantages that serve 
the interests of stakeholders. 82 FR 752. The proposed formulas would 
bring Trust Fund payments in line with industry standards, help protect 
the Trust Fund from inaccurate and excessive payments, ease recouping 
of medical benefits paid by the Trust Fund on a liable operator's 
behalf, and conserve the Trust Fund's limited resources. Id. 
Additionally, the new formulas would decrease administrative costs, 
reduce disparities in provider reimbursements, shorten the time period 
providers must wait for reimbursement, and provide all stakeholders 
with greater clarity and certainty regarding the black lung medical 
benefit payment process. Id.
    The Department received one comment suggesting that the economic 
analysis in the NPRM improperly focused solely on the nation-wide 
impacts of the proposed rules. This is incorrect. In addition to 
considering the overall impact of the proposed rules, the analysis 
addressed the impact of the proposed payment formulas on a state-by-
state basis. See 82 FR 746-751.
    The same commenter takes issue with a statement in the NPRM's 
economic analysis that any decline in the number of entitled claimants 
may result in a decline in payments by the Trust Fund, even apart from 
any change in payments resulting from the new payment formulas. See 82 
FR 751. The commenter suggests that claims filed by miners with 
complicated pneumoconiosis, a more serious form of the disease, are in 
fact increasing in certain areas. The Department did not mean to 
suggest that miners would be less likely to contract pneumoconiosis in 
the future or that the number of claims filed could not fluctuate from 
year to year. Rather, the Department was simply noting that there had 
been a long-term decline in both the number of beneficiaries covered, 
and medical benefit payments made, by the Trust Fund. See id., n.17.
    The Department received no other comments calling its cost-benefit 
analysis into question. Thus, the Department continues to believe that 
the cost savings and other benefits of this rule support its 
promulgation.
    The Office of Information and Regulatory Affairs of the Office of 
Management and Budget has determined that this rule is a ``significant 
regulatory action'' under section 3(f)(4) of Executive Order 12866 and 
has reviewed it.

VI. Regulatory Flexibility Act and Executive Order 13272 (Proper 
Consideration of Small Entities in Agency Rulemaking)

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601 et seq., 
and Executive Order 13272 require agencies to review proposed and final 
rules to assess their impact on small entities. The agency must 
determine whether a proposed rule may have a ``significant'' economic 
impact on a ``substantial'' number of small entities, including small 
businesses, not-for-profit organizations, and small governmental 
jurisdictions. See 5 U.S.C. 603. If the agency estimates that a 
proposed rule would have a significant impact on a substantial number 
of small entities, then it must prepare an initial regulatory 
flexibility analysis as described in the RFA. Id. The RFA also requires 
agencies to prepare a final regulatory flexibility analysis when 
promulgating a final rule. 5 U.S.C. 604. However, the RFA does not 
require a regulatory flexibility analysis if the agency certifies that 
the proposed or final rule will not have a significant economic impact 
on a substantial number of small entities and provides the factual 
basis for the certification. 5 U.S.C. 605. The Department has 
determined that a final regulatory flexibility analysis is not required 
for this rulemaking.
    The Department conducted an initial regulatory flexibility analysis 
to aid understanding of the impact of the proposed rule and invited 
comments on all aspects of the costs and benefits of the proposed rule, 
with particular attention to the effects of the rule on small entities. 
See 82 FR 752-765. To determine whether the rule would have a 
significant impact on a small entity,

[[Page 27695]]

the Department used as its standard whether the rule would impose costs 
that equal or exceed 3% or more of the entity's annual revenue. 82 FR 
752. Applying this standard, the Department considered whether the rule 
would significantly impact 15% or more of the small entities in the 
relevant industry. 82 FR 752-53. The Department separately examined the 
rule's impact on small entities of each provider type (non-hospital 
health care services providers, hospitals providing outpatient 
services, and hospitals providing inpatient services) affected by the 
rule. 82 FR 753-764. The Department estimated that the rule will not 
have a significant impact on any small entity providing non-hospital 
health care services. 82 FR 759. The Department estimated that one 
small hospital entity providing outpatient services and two providing 
inpatient services will be significantly impacted, but these entities 
do not constitute a substantial number of the total number of 
negatively affected small hospitals providing either outpatient or 
inpatient services. 82 FR 761, 763. The Department noted that its 
analysis likely overstated the impact of the rule on negatively 
affected small entities. 82 FR 765. The Department therefore concluded 
that the rule, if adopted, would not have a significant impact on a 
substantial number of small entities. Id.
    No comments were received that raise a significant issue regarding 
the initial regulatory flexibility analysis or that provide a basis for 
departing from the conclusion reached in the analysis. Significantly, 
with the exception of CAHs, no commenter or interested small business 
brought forth any information that contradicts the Department's 
assumptions or conclusions in the initial regulatory flexibility 
analysis, despite the Department's specific request for comments about 
adverse effects on small businesses. And the Department's 
determination, as explained in the Section-by-Section Explanation 
above, to exclude CAHs from the new payment formulas renders the 
request to analyze the impact of those formulas on CAHs moot.
    Based on these facts, the Department certifies for the purposes of 
5 U.S.C. 605(b) that this rule will not have a significant economic 
impact on a substantial number of small entities. Accordingly, it has 
not prepared a final regulatory impact analysis. The Department will 
provide the Chief Counsel for Advocacy of the Small Business 
Administration with a copy of this certification. See 5 U.S.C. 605.

VII. Executive Order 13771 (Reducing Regulation and Controlling 
Regulatory Costs)

    This final rule is not subject to the requirements of Executive 
Order 13771 because this final rule addresses transfer costs and does 
not impose any new requirements apart from the transfers. OMB's interim 
guidance on E.O. 13771 (Para II, Q2) (February 2, 2017) and OMB 
additional guidance on E.O. 13771 (Para III, Q13) (April 5, 2017); see 
also 82 FR 746, 748-49 (recognizing rules as implicating transfer 
costs).

VIII. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 
et seq., directs agencies to assess the effects of Federal Regulatory 
Actions on State, local, and tribal governments, and the private 
sector, ``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' 2 U.S.C. 1531. For 
purposes of the Unfunded Mandates Reform Act, this rule does not 
include any Federal mandate that may result in increased expenditures 
by State, local, tribal governments, or increased expenditures by the 
private sector of more than $100,000,000.

IX. Executive Order 13132 (Federalism)

    The Department has reviewed this rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The rule will not ``have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' Id.

X. Executive Order 12988 (Civil Justice Reform)

    This rule meets the applicable standards in sections 3(a) and 
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize 
litigation, eliminate ambiguity, and reduce burden.

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a report, which includes a copy of the rule, to 
each House of Congress and to the Comptroller General of the United 
States. OWCP will report this rule's promulgation to each House of 
Congress and the Comptroller General simultaneously with publication of 
the rule in the Federal Register. The report will state that the rule 
is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 20 CFR Part 725

    Administrative practice and procedure, Black lung benefits, Claims, 
Coal miners' entitlement to benefits, Health care, Reporting and 
recordkeeping requirements, Survivors' entitlement to benefits, Total 
disability due to pneumoconiosis, Vocational rehabilitation, Workers' 
compensation.

    For the reasons set forth in the preamble, the Department of Labor 
amends 20 CFR part 725 as follows:

PART 725--CLAIMS FOR BENEFITS UNDER PART C OF TITLE IV OF THE 
FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED

0
1. The authority citation for part 725 continues to read as follows:

    Authority:  5 U.S.C. 301; 28 U.S.C. 2461 note (Federal Civil 
Penalties Inflation Adjustment Act of 1990); Pub. L. 114-74 at sec. 
701; Reorganization Plan No. 6 of 1950, 15 FR 3174; 30 U.S.C. 901 et 
seq., 902(f), 921, 932, 936; 33 U.S.C. 901 et seq.; 42 U.S.C. 405; 
Secretary's Order 10-2009, 74 FR 58834.

0
2. Amend Sec.  725.308 as follows:
0
a. Remove paragraph (b);
0
b. Redesignate paragraph (c) as paragraph (b);
0
c. Remove from the second sentence in redesignated paragraph (b) 
``However, except as provided in paragraph (b) of this section, the'' 
and add in its place ``The''.

0
3. In part 725, revise subpart J to read as follows:
Subpart J--Medical Benefits and Vocational Rehabilitation
Sec.
725.701 What medical benefits are available?
725.702 Who is considered a physician?
725.703 How is treatment authorized?
725.704 How are arrangements for medical care made?
725.705 Is prior authorization for medical services required?
725.706 What reports must a medical provider give to OWCP?
725.707 At what rate will fees for medical services and treatments 
be paid?
725.708 How are payments for professional medical services and 
medical equipment determined?
725.709 How are payments for prescription drugs determined?
725.710 How are payments for outpatient medical services determined?
725.711 How are payments for inpatient medical services determined?
725.712 When and how are fees reduced?
725.713 If a fee is reduced, may a provider bill the claimant for 
the balance?
725.714 How do providers enroll with OWCP for authorizations and 
billing?

[[Page 27696]]

725.715 How do providers submit medical bills?
725.716 How should a miner prepare and submit requests for 
reimbursement for covered medical expenses and transportation costs?
725.717 What are the time limitations for requesting payment or 
reimbursement for covered medical services or treatments?
725.718 How are disputes concerning medical benefits resolved?
725.719 What is the objective of vocational rehabilitation?
725.720 How does a miner request vocational rehabilitation 
assistance?

Subpart J--Medical Benefits and Vocational Rehabilitation


Sec.  725.701   What medical benefits are available?

    (a) A miner who is determined to be eligible for benefits under 
this part or part 727 of this subchapter (see Sec.  725.4(d)) is 
entitled to medical benefits as set forth in this subpart as of the 
date of his or her claim, but in no event before January 1, 1974. 
Medical benefits may not be provided to the survivor or dependent of a 
miner under this part.
    (b) A responsible operator, or where there is none, the fund, must 
furnish a miner entitled to benefits under this part with such medical 
services and treatments (including professional medical services and 
medical equipment, prescription drugs, outpatient medical services, 
inpatient medical services, and any other medical service, treatment or 
supply) for such periods as the nature of the miner's pneumoconiosis 
and disability requires.
    (c) The medical benefits referred to in paragraphs (a) and (b) of 
this section include palliative measures useful only to prevent pain or 
discomfort associated with the miner's pneumoconiosis or attendant 
disability.
    (d) An operator or the fund must also pay the miner's reasonable 
cost of travel necessary for medical treatment (to be determined in 
accordance with prevailing United States government mileage rates) and 
the reasonable documented cost to the miner or medical provider 
incurred in communicating with the operator, carrier, or OWCP on 
matters connected with medical benefits.
    (e)(1) If a miner receives a medical service or treatment, as 
described in this section, for any pulmonary disorder, there will be a 
rebuttable presumption that the disorder is caused or aggravated by the 
miner's pneumoconiosis.
    (2) The party liable for the payment of benefits may rebut the 
presumption by producing credible evidence that the medical service or 
treatment provided was for a pulmonary disorder apart from those 
previously associated with the miner's disability, or was beyond that 
necessary to effectively treat a covered disorder, or was not for a 
pulmonary disorder at all.
    (3) An operator or the fund, however, cannot rely on evidence that 
the miner does not have pneumoconiosis or is not totally disabled by 
pneumoconiosis arising out of coal mine employment to defeat a request 
for coverage of any medical service or treatment under this subpart.
    (4) In determining whether the treatment is compensable, the 
opinion of the miner's treating physician may be entitled to 
controlling weight pursuant to Sec.  718.104(d) of this subchapter.
    (5) A finding that a medical service or treatment is not covered 
under this subpart will not otherwise affect the miner's entitlement to 
benefits.


Sec.  725.702   Who is considered a physician?

    The term ``physician'' includes only doctors of medicine (MD) and 
doctors of osteopathy (DO) within the scope of their practices as 
defined by State law. No treatment or medical services performed by any 
other practitioner of the healing arts is authorized by this part, 
unless such treatment or service is authorized and supervised both by a 
physician as defined in this section and by OWCP.


Sec.  725.703   How is treatment authorized?

    (a) Upon notification to a miner of such miner's entitlement to 
benefits, OWCP must provide the miner with a list of authorized 
treating physicians and medical facilities in the area of the miner's 
residence. The miner may select a physician from this list or may 
select another physician with approval of OWCP. Where emergency 
services are necessary and appropriate, authorization by OWCP is not 
required.
    (b) OWCP may, on its own initiative, or at the request of a 
responsible operator, order a change of physicians or facilities, but 
only where it has been determined that the change is desirable or 
necessary in the best interest of the miner. The miner may change 
physicians or facilities subject to the approval of OWCP.
    (c) If adequate treatment cannot be obtained in the area of the 
claimant's residence, OWCP may authorize the use of physicians or 
medical facilities outside such area as well as reimbursement for 
travel expenses and overnight accommodations.


Sec.  725.704   How are arrangements for medical care made?

    (a) Operator liability. If an operator has been determined liable 
for the payment of benefits to a miner, OWCP will notify the operator 
or its insurance carrier of the names, addresses, and telephone numbers 
of the authorized providers of medical benefits chosen by an entitled 
miner, and require the operator or carrier to:
    (1) Notify the miner and the providers chosen that the operator or 
carrier will be responsible for the cost of medical services provided 
to the miner on account of the miner's total disability due to 
pneumoconiosis;
    (2) Designate a person or persons with decision-making authority 
with whom OWCP, the miner and authorized providers may communicate on 
matters involving medical benefits provided under this subpart and 
notify OWCP, the miner and providers of this designation;
    (3) Make arrangements for the direct reimbursement of providers for 
their services.
    (b) Fund liability. If there is no operator found liable for the 
payment of benefits, OWCP will make necessary arrangements to provide 
medical care to the miner, notify the miner and providers selected of 
the liability of the fund, designate a person or persons with whom the 
miner or provider may communicate on matters relating to medical care, 
and make arrangements for the direct reimbursement of the medical 
provider.


Sec.  725.705   Is prior authorization for medical services required?

    (a) Except as provided in paragraph (b) of this section, medical 
services from an authorized provider which are payable under Sec.  
725.701 do not require prior approval of OWCP or the responsible 
operator.
    (b) Except where emergency treatment is required, prior approval of 
OWCP or the responsible operator must be obtained before any 
hospitalization or surgery, or before ordering medical equipment where 
the purchase price exceeds $300. A request for approval of non-
emergency hospitalization or surgery must be acted upon expeditiously, 
and approval or disapproval will be given by telephone if a written 
response cannot be given within 7 days following the request. No 
employee of the Department of Labor, other than a district director or 
the Chief, Medical Audit and Operations Section, DCMWC, is authorized 
to approve a request for hospitalization or surgery by telephone.


Sec.  725.706   What reports must a medical provider give to OWCP?

    (a) Within 30 days following the first medical or surgical 
treatment provided

[[Page 27697]]

under Sec.  725.701, the provider must furnish to OWCP and the 
responsible operator or its insurance carrier, if any, a report of such 
treatment.
    (b) In order to permit continuing supervision of the medical care 
provided to the miner with respect to the necessity, character and 
sufficiency of any medical care furnished or to be furnished, the 
provider, operator or carrier must submit such reports in addition to 
those required by paragraph (a) of this section as OWCP may from time 
to time require. Within the discretion of OWCP, payment may be refused 
to any medical provider who fails to submit any report required by this 
section.


Sec.  725.707   At what rate will fees for medical services and 
treatments be paid?

    (a) All fees charged by providers for any medical service, 
treatment, drug or equipment authorized under this subpart will be paid 
at no more than the rate prevailing for the service, treatment, drug or 
equipment in the community in which the provider is located.
    (b) When medical benefits are paid by the fund at OWCP's direction, 
either on an interim basis or because there is no liable operator, the 
prevailing community rate for various types of service will be 
determined as provided in Sec. Sec.  725.708-725.711.
    (c) The provisions of Sec. Sec.  725.708-725.711 do not apply to 
charges for medical services or treatments furnished by medical 
facilities of the U.S. Public Health Service or the Departments of the 
Army, Navy, Air Force and Veterans Affairs.
    (d) If the provisions of Sec. Sec.  725.708-725.711 cannot be used 
to determine the prevailing community rate for a particular service or 
treatment or for a particular provider, OWCP may determine the 
prevailing community rate by reliance on other federal or state payment 
formulas or on other evidence, as appropriate.
    (e) OWCP must review the payment formulas described in Sec. Sec.  
725.708-725.711 at least once a year, and may adjust, revise or replace 
any payment formula or its components when necessary or appropriate to 
ensure miners' access to care or for other reasons.
    (f) Except as otherwise provided in this subpart, the provisions of 
Sec. Sec.  725.707-725.711 apply to all medical services and treatments 
rendered after August 31, 2018.


Sec.  725.708   How are payments for professional medical services and 
medical equipment determined?

    (a)(1) OWCP pays for professional medical services based on a fee 
schedule derived from the schedule maintained by the Centers for 
Medicare & Medicaid Services (CMS) for the payment of such services 
under the Medicare program (42 CFR part 414). The schedule OWCP 
utilizes consists of: An assignment of Relative Value Units (RVU) to 
procedures identified by Healthcare Common Procedure Coding System/
Current Procedural Terminology (HCPCS/CPT) code, which represents the 
work (relative time and intensity of the service), the practice expense 
and the malpractice expense, as compared to other procedures of the 
same general class; an assignment of Geographic Practice Cost Index 
(GPCI) values, which represent the relative work, practice expense and 
malpractice expense relative to other localities throughout the 
country; and a monetary value assignment (conversion factor) for one 
unit of value for each coded service.
    (2) The maximum payment for professional medical services 
identified by a HCPCS/CPT code is calculated by multiplying the RVU 
values for the service by the GPCI values for such service in that area 
and multiplying the sum of these values by the conversion factor to 
arrive at a dollar amount assigned to one unit in that category of 
service.
    (3) OWCP utilizes the RVUs published, and updated or revised from 
time to time, by CMS for all services for which CMS has made 
assignments. Where there are no RVUs assigned, OWCP may develop and 
assign any RVUs that OWCP considers appropriate. OWCP utilizes the GPCI 
for the locality as defined by CMS and as updated or revised by CMS 
from time to time. OWCP will devise conversion factors for professional 
medical services using OWCP's processing experience and internal data.
    (b) Where a professional medical service is not covered by the fee 
schedule described in paragraph (a) of this section, OWCP may pay for 
the service based on other fee schedules or pricing formulas utilized 
by OWCP for professional medical services.
    (c) Paragraphs (a) and (b) of this section apply to professional 
medical services rendered after November 30, 2019.
    (d) OWCP pays for medical equipment identified by a HCPCS/CPT code 
based on fee schedules or other pricing formulas utilized by OWCP for 
such equipment.


Sec.  725.709   How are payments for prescription drugs determined?

    (a)(1) OWCP pays for drugs prescribed by physicians by multiplying 
a percentage of the average wholesale price, or other baseline price as 
specified by OWCP, of the medication by the quantity or amount 
provided, plus a dispensing fee.
    (2) All prescription medications identified by National Drug Code 
are assigned an average wholesale price representing the product's 
nationally recognized wholesale price as determined by surveys of 
manufacturers and wholesalers, or another baseline price designated by 
OWCP.
    (3) OWCP may establish the dispensing fee.
    (b) If the pricing formula described in paragraph (a) of this 
section is inapplicable, OWCP may make payment based on other pricing 
formulas utilized by OWCP for prescription medications.
    (c) OWCP may, in its discretion, contract for or require the use of 
specific providers for certain medications. OWCP also may require the 
use of generic equivalents of prescribed medications where they are 
available.


Sec.  725.710   How are payments for outpatient medical services 
determined?

    (a)(1) Except as provided in paragraphs (b) and (c) of this 
section, OWCP pays for outpatient medical services according to 
Ambulatory Payment Classifications (APCs) derived from the Outpatient 
Prospective Payment System (OPPS) devised by the Centers for Medicare & 
Medicaid Services (CMS) for the Medicare program (42 CFR part 419).
    (2) For outpatient medical services paid under the OPPS, such 
services are assigned according to the APC prescribed by CMS for that 
service. Each payment is derived by multiplying the prospectively 
established scaled relative weight for the service's clinical APC by a 
conversion factor to arrive at a national unadjusted payment rate for 
the APC. The labor portion of the national unadjusted payment rate is 
further adjusted by the hospital wage index for the area where payment 
is being made. Additional adjustments are also made as required or 
needed.
    (b) If a compensable service cannot be assigned or paid at the 
prevailing community rate under the OPPS or occurs at a facility 
excluded from the Medicare OPPS, OWCP may pay for the service based on 
fee schedules or other pricing formulas utilized by OWCP for outpatient 
services.
    (c) This section does not apply to services provided by ambulatory 
surgical centers.
    (d) This section applies to outpatient medical services rendered 
after November 30, 2019.

[[Page 27698]]

Sec.  725.711   How are payments for inpatient medical services 
determined?

    (a)(1) OWCP pays for inpatient medical services according to 
predetermined rates derived from the Medicare Inpatient Prospective 
Payment System (IPPS) used by the Centers for Medicare & Medicaid 
Services (CMS) for the Medicare program (42 CFR part 412).
    (2) Inpatient hospital discharges are classified into diagnosis-
related groups (DRGs). Each DRG groups together clinically similar 
conditions that require comparable amounts of inpatient resources. For 
each DRG, an appropriate weighting factor is assigned that reflects the 
estimated relative cost of hospital resources used with respect to 
discharges classified within that group compared to discharges 
classified within other groups.
    (3) For each hospital discharge classified within a DRG, a payment 
amount for that discharge is determined by using the national weighting 
factor determined for that DRG, national standardized adjustments, and 
other factors which may vary by hospital, such as an adjustment for 
area wage levels. OWCP may also use other price adjustment factors as 
appropriate based on its processing experience and internal data.
    (b) If an inpatient service cannot be classified by DRG, occurs at 
a facility excluded from the Medicare IPPS, or otherwise cannot be paid 
at the prevailing community rate under the pricing formula described in 
paragraph (a) of this section, OWCP may pay for the service based on 
fee schedules or other pricing formulas utilized by OWCP for inpatient 
services.


Sec.  725.712   When and how are fees reduced?

    (a) A provider's designation of the code used to identify a billed 
service or treatment will be accepted if the code is consistent with 
the medical and other evidence, and the provider will be paid no more 
than the maximum allowable fee for that service or treatment. If the 
code is not consistent with the medical evidence or where no code is 
supplied, the bill will be returned to the provider for correction and 
resubmission or denied.
    (b) If the charge submitted for a service or treatment supplied to 
a miner exceeds the maximum amount determined to be reasonable under 
this subpart, OWCP must pay the amount allowed by Sec. Sec.  725.707-
725.711 for that service and notify the provider in writing that 
payment was reduced for that service in accordance with those 
provisions.
    (c) A provider or other party who disagrees with a fee 
determination may seek review of that determination as provided in this 
subpart (see Sec.  725.718).


Sec.  725.713   If a fee is reduced, may a provider bill the claimant 
for the balance?

    Where a provider submits a bill to OWCP and OWCP has reduced the 
provider's fee, the miner is not responsible for any additional payment 
for services or treatments covered under this subpart. Thus, a provider 
whose fee for service is partially paid by OWCP as a result of the 
application of the provisions of Sec. Sec.  725.707-725.711 or 
otherwise in accordance with this subpart may not request reimbursement 
from the miner for additional amounts.


Sec.  725.714   How do providers enroll with OWCP for authorizations 
and billing?

    (a) All non-pharmacy providers seeking payment from the fund must 
enroll with OWCP or its designated bill processing agent to have access 
to the automated authorization system and to submit medical bills to 
OWCP.
    (b) To enroll, the non-pharmacy provider must complete and submit a 
Form OWCP-1168 to the appropriate location noted on that form. By 
completing and submitting this form, providers certify that they 
satisfy all applicable Federal and State licensure and regulatory 
requirements that apply to their specific provider or supplier type.
    (c) The non-pharmacy provider must maintain documentary evidence 
indicating that it satisfies those requirements.
    (d) The non-pharmacy provider must also notify OWCP immediately if 
any information provided to OWCP in the enrollment process changes.
    (e) All pharmacy providers must obtain a National Council for 
Prescription Drug Programs number. Upon obtaining such number, they are 
automatically enrolled in OWCP's pharmacy billing system.
    (f) After enrollment, a provider must submit all medical bills to 
OWCP through its bill processing portal or to the OWCP address 
specified for such purpose and must include the Provider Number/ID 
obtained through enrollment, or its National Provider Number (NPI) or 
any other identifying numbers required by OWCP.


Sec.  725.715   How do providers submit medical bills?

    (a) A provider must itemize charges on Form OWCP-1500 or CMS-1500 
(for professional services, equipment or drugs dispensed in the 
office), Form OWCP-04 or UB-04 (for hospitals), an electronic or paper-
based bill that includes required data elements (for pharmacies) or 
other form as designated by OWCP, and submit the form promptly to OWCP.
    (b) The provider must identify each medical service performed using 
the Current Procedural Terminology (CPT) code, the Healthcare Common 
Procedure Coding System (HCPCS) code, the National Drug Code (NDC) 
number, or the Revenue Center Code (RCC), as appropriate to the type of 
service. OWCP has discretion to determine which of these codes may be 
utilized in the billing process. OWCP also has the authority to create 
and supply codes for specific services or treatments. These OWCP-
created codes will be issued to providers by OWCP as appropriate and 
may only be used as authorized by OWCP. A provider may not use an OWCP-
created code for other types of medical examinations, services or 
treatments.
    (1) For professional medical services, the provider must list each 
diagnosed condition in order of priority and furnish the corresponding 
diagnostic code using the ``International Classification of Disease, 
10th Edition, Clinical Modification'' (ICD-10-CM), or as revised.
    (2) For prescription drugs or supplies, the provider must include 
the NDC assigned to the product, and such other information as OWCP may 
require.
    (3) For outpatient medical services, the provider must use HCPCS 
codes and other coding schemes in accordance with the Outpatient 
Prospective Payment System.
    (4) For inpatient medical services, the provider must include 
admission and discharge summaries and an itemized statement of the 
charges.
    (c)(1) By submitting a bill or accepting payment, the provider 
signifies that the service for which reimbursement is sought was 
performed as described, necessary, appropriate, and properly billed in 
accordance with accepted industry standards. For example, accepted 
industry standards preclude upcoding billed services for extended 
medical appointments when the miner actually had a brief routine 
appointment, or charging for the services of a professional when a 
paraprofessional or aide performed the service; industry standards 
prohibit unbundling services to charge separately for services that 
should be billed as a single charge.
    (2) The provider agrees to comply with all regulations set forth in 
this subpart concerning the provision of medical services or treatments 
and/or the process for seeking reimbursement for medical services and 
treatments,

[[Page 27699]]

including the limitation imposed on the amount to be paid.


Sec.  725.716   How should a miner prepare and submit requests for 
reimbursement for covered medical expenses and transportation costs?

    (a) If a miner has paid bills for a medical service or treatment 
covered under Sec.  725.701 and seeks reimbursement for those expenses, 
he or she may submit a request for reimbursement on Form OWCP-915, 
together with an itemized bill. The reimbursement request must be 
accompanied by evidence that the provider received payment for the 
service from the miner and a statement of the amount paid. Acceptable 
evidence that payment was received includes, but is not limited to, a 
copy of the miner's canceled check (both front and back) or a copy of 
the miner's credit card receipt.
    (b) OWCP may waive the requirements of paragraph (a) of this 
section if extensive delays in the filing or the adjudication of a 
claim make it unusually difficult for the miner to obtain the required 
information.
    (c) Reimbursements for covered medical services paid by a miner 
generally will be no greater than the maximum allowable charge for such 
service as determined under Sec. Sec.  725.707-725.711.
    (d) A miner will be only partially reimbursed for a covered medical 
service if the amount he or she paid to a provider for the service 
exceeds the maximum charge allowable. If this happens, OWCP will advise 
the miner of the maximum allowable charge for the service in question 
and of his or her responsibility to ask the provider to refund to the 
miner, or credit to the miner's account, the amount he or she paid 
which exceeds the maximum allowable charge.
    (e) If the provider does not refund to the miner or credit to his 
or her account the amount of money paid in excess of the charge allowed 
by OWCP, the miner should submit documentation to OWCP of the attempt 
to obtain such refund or credit. OWCP may make reasonable reimbursement 
to the miner after reviewing the facts and circumstances of the case.
    (f) If a miner has paid transportation costs or other incidental 
expenses related to covered medical services under this part, the miner 
may submit a request for reimbursement on Form OWCP-957 or OWCP-915, 
together with proof of payment.


Sec.  725.717   What are the time limitations for requesting payment or 
reimbursement for covered medical services or treatments?

    OWCP will pay providers and reimburse miners promptly for all bills 
received on an approved form and in a timely manner. However, absent 
good cause, no bill will be paid for expenses incurred if the bill is 
submitted more than one year beyond the end of the calendar year in 
which the expense was incurred or the service or supply was provided, 
or more than one year beyond the end of the calendar year in which the 
miner's eligibility for benefits is finally adjudicated, whichever is 
later. A provider may not request reimbursement from a miner for a bill 
denied by OWCP due to late submission of the bill by the provider.


Sec.  725.718   How are disputes concerning medical benefits resolved?

    (a) If a dispute develops concerning medical services or treatments 
or their payment under this part, OWCP must attempt to informally 
resolve the dispute. OWCP may, on its own initiative or at the request 
of the responsible operator or its insurance carrier, order the 
claimant to submit to an examination by a physician selected by OWCP.
    (b) If a dispute cannot be resolved informally, OWCP will refer the 
case to the Office of Administrative Law Judges for a hearing in 
accordance with this part. Any such hearing concerning authorization of 
medical services or treatments must be scheduled at the earliest 
possible time and must take precedence over all other hearing requests 
except for other requests under this section and as provided by Sec.  
727.405 of this subchapter (see Sec.  725.4(d)). During the pendency of 
such adjudication, OWCP may order the payment of medical benefits prior 
to final adjudication under the same conditions applicable to benefits 
awarded under Sec.  725.522.
    (c) In the development or adjudication of a dispute over medical 
benefits, the adjudication officer is authorized to take whatever 
action may be necessary to protect the health of a totally disabled 
miner.
    (d) Any interested medical provider may, if appropriate, be made a 
party to a dispute under this subpart.


Sec.  725.719   What is the objective of vocational rehabilitation?

    The objective of vocational rehabilitation is the return of a miner 
who is totally disabled by pneumoconiosis to gainful employment 
commensurate with such miner's physical impairment. This objective may 
be achieved through a program of re-evaluation and redirection of the 
miner's abilities, or retraining in another occupation, and selective 
job placement assistance.


Sec.  725.720   How does a miner request vocational rehabilitation 
assistance?

    Each miner who has been determined entitled to receive benefits 
under part C of title IV of the Act must be informed by OWCP of the 
availability and advisability of vocational rehabilitation services. If 
such miner chooses to avail himself or herself of vocational 
rehabilitation, his or her request will be processed and referred by 
OWCP vocational rehabilitation advisors pursuant to the provisions of 
Sec. Sec.  702.501 through 702.508 of this chapter as is appropriate.

    Dated: June 5, 2018.
Julia K. Hearthway,
Director, Office of Workers' Compensation Programs.
[FR Doc. 2018-12418 Filed 6-13-18; 8:45 am]
 BILLING CODE 4510-CR-P