Black Lung Benefits Act: Medical Benefit Payments, 27690-27699 [2018-12418]
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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations
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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,
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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
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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).
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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
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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
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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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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
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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
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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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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.
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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
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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.
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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.
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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.
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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
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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
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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.
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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
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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?
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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
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§ 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
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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
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(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.
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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.
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§ 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
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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
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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.
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§ 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.
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(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
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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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§ 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.
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§ 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
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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:
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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]
=======================================================================
-----------------------------------------------------------------------
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 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