27690 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 

AIRAC date State City Airport FDC No. FDC date Subject 

19-Jul-18 ...... NE Norfolk ................... Norfolk Rgnl/Karl Stefan Memorial Fld.8/8711 5/21/18 VOR Rwy 19, Amdt 8 

19-Jul-18 ...... MO St Louis ................. Creve Coeur .......................... 8/9092 5/21/18 Takeoff Minimums and Obstacle 

DP, Amdt 2 

19-Jul-18 ...... MA Beverly .................. Beverly Rgnl .......................... 8/9547 5/21/18 RNAV (GPS) Rwy 27, Amdt 1A 

19-Jul-18 ...... SC Aiken ..................... Aiken Muni ............................ 8/9658 5/21/18 ILS OR LOC/DME Rwy 7, Orig-C 

19-Jul-18 ...... SC Aiken ..................... Aiken Muni ............................ 8/9659 5/21/18 NDB Rwy 25, Amdt 10C 

19-Jul-18 ...... SC Aiken ..................... Aiken Muni ............................ 8/9660 5/21/18 RNAV (GPS) Rwy 25, Amdt 1C 

19-Jul-18 ...... SC Aiken ..................... Aiken Muni ............................ 8/9661 5/21/18 RNAV (GPS) Rwy 7, Amdt 1C 

19-Jul-18 ...... SC Aiken ..................... Aiken Muni ............................ 8/9662 5/21/18 VOR/DME–A, Amdt 1A 

[FR Doc. 2018–12710 Filed 6–13–18; 8:45 am] 

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 

AGENCY: Office of Workers’ 

Compensation Programs, Labor. 

ACTION: Final rule. 

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 

§ 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, 


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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: 

§§ 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 

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 

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 


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27692 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 

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 

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 

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 


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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 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 § 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 

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. 

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. 


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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. 

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 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 

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, 


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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 

■ 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? 


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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 

§ 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 

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? 

(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. 

§ 725.704 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. 

§ 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 § 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. 

§ 725.706 What reports must a medical 

provider give to OWCP? 

(a) Within 30 days following the first 

medical or surgical treatment provided 


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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. 

§ 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 

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 

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. 


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§ 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. 

§ 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. 

(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 

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, 


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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 27699 

including the limitation imposed on the 

amount to be paid. 

§ 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 § 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. 

§ 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. 

§ 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 

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. 

SUMMARY: 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 


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