83_FR_42760 83 FR 42596 - Medicare Program; Certain Changes to the Low-Volume Hospital Payment Adjustment Under the Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals for Fiscal Years 2011 Through 2017

83 FR 42596 - Medicare Program; Certain Changes to the Low-Volume Hospital Payment Adjustment Under the Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals for Fiscal Years 2011 Through 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 164 (August 23, 2018)

Page Range42596-42600
FR Document2018-18271

This document announces changes to the payment adjustment for low-volume hospitals under the hospital inpatient prospective payment systems (IPPS) for acute care hospitals for fiscal years (FYs) 2011 through 2017 in accordance with section 429 of the Consolidated Appropriations Act, 2018.

Federal Register, Volume 83 Issue 164 (Thursday, August 23, 2018)
[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Rules and Regulations]
[Pages 42596-42600]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 412

[CMS-1709-N]
RIN 0938-ZB49


Medicare Program; Certain Changes to the Low-Volume Hospital 
Payment Adjustment Under the Hospital Inpatient Prospective Payment 
Systems (IPPS) for Acute Care Hospitals for Fiscal Years 2011 Through 
2017

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Application of a payment adjustment.

-----------------------------------------------------------------------

SUMMARY: This document announces changes to the payment adjustment for 
low-volume hospitals under the hospital inpatient prospective payment 
systems (IPPS) for acute care hospitals for fiscal years (FYs) 2011 
through 2017 in accordance with section 429 of the Consolidated 
Appropriations Act, 2018.

DATES: Effective date: August 22, 2018.
    Applicability date: The provisions described in this document are 
applicable for discharges on or after October 1, 2010, and on or before 
September 30, 2017, in accordance with section 429 of the Consolidated 
Appropriations Act, 2018.

FOR FURTHER INFORMATION CONTACT: Michele Hudson, (410) 786-5490.; Mark 
Luxton, (410) 786-4530.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 23, 2018 the Consolidated Appropriations Act, 2018 (Pub. 
L. 115-141) was enacted. Section 429 of the Consolidated Appropriations 
Act, 2018 makes certain changes to the payment adjustment for low-
volume hospitals for fiscal years (FYs) 2011 through 2017 relating to 
the application of the mileage criterion for Indian Health Service and 
non-Indian Health Service facilities.

II. Provisions of the Document

A. Changes to the Payment Adjustment for Low-Volume Hospitals in FYs 
2011 Through 2017

1. Background
    Section 1886(d)(12) of the Act provides for an additional payment 
to each qualifying low-volume hospital under the Hospital Inpatient 
Prospective Payment Systems (IPPS) for Acute Care Hospitals beginning 
in FY 2005. CMS implemented this provision in the regulations at 42 CFR 
412.101. The payment adjustment to a low-volume hospital provided for 
under section 1886(d)(12) of the Act is ``[i]n addition to any payment 
calculated under this section.'' Therefore, meaning the payment 
adjustment is based on the per discharge amount paid to the qualifying 
hospital under section 1886 of the Act. In other words, the low-volume 
hospital payment adjustment is based on total per discharge payments 
made under section 1886 of the Act, including capital, disproportionate 
share hospital (DSH), indirect medical education (IME), and outlier 
payments. For sole community hospitals (SCHs) and Medicare-dependent 
hospitals (MDHs), the low-volume hospital payment adjustment is based 
in part on either the Federal rate or the hospital-specific rate, 
whichever results in a greater operating IPPS payment.
    The Affordable Care Act amended section 1886(d)(12) of the Act by 
modifying the definition of a low-volume hospital and the methodology 
for calculating the payment adjustment for low-volume hospitals, 
effective only for discharges occurring during FYs 2011 and 2012, and 
subsequent legislation extended those temporary modifications through 
FY 2018. (The most recent statutory extension of those temporary 
changes to the low-volume hospital payment policy was for FY 2018 and 
is discussed in a document

[[Page 42597]]

(CMS 1677-N) that appeared in the April 26, 2018 Federal Register (83 
FR 18301).) Specifically, those provisions amended the qualifying 
criteria for low volume hospitals under section 1886(d)(12)(C)(i) of 
the Act to specify that, for FYs 2011 through 2018, a subsection (d) 
hospital qualifies as a low-volume hospital if it is more than 15 road 
miles from another subsection (d) hospital and has less than 1,600 
discharges of individuals entitled to, or enrolled for, benefits under 
Part A during the fiscal year. In addition, these provisions amended 
section 1886(d)(12)(D) of the Act to provide that for FYs 2011 through 
2018, the low-volume hospital payment adjustment (that is, the 
percentage increase) is to be determined using a continuous linear 
sliding scale ranging from 25 percent for low-volume hospitals with 200 
or fewer discharges of individuals entitled to, or enrolled for, 
benefits under Part A in the fiscal year to zero percent for low-volume 
hospitals with greater than 1,600 discharges of such individuals in the 
fiscal year. (We note that under Sec.  412.101(b)(2)(ii), for FYs 2011 
through 2017, a hospital's Medicare discharges from the most recently 
available MedPAR data, as determined by CMS, are used to determine 
whether the hospital meets the discharge criterion to receive the low 
volume hospital payment adjustment in the applicable fiscal year. In 
the FY 2019 IPPS/LTCH PPS final rule, we finalized conforming changes 
to this provision to reflect that the low-volume hospital payment 
adjustment policy in effect for FY 2018 is the same low-volume hospital 
payment adjustment policy in effect for FYs 2011 through 2017 (83 FR 
41144, August 17, 2018).
2. Treatment of Indian Health Service and Non-Indian Health Service 
Facilities
    Section 1886(d)(12)(C) of the Act requires that, in order to 
qualify for the low volume hospital payment adjustment, a hospital must 
be located more than a specified number of miles from the nearest 
subsection (d) hospital (referred to as the mileage criterion, which is 
implemented at Sec.  412.101(b)(2)). Since CMS considers Indian Health 
Service (IHS) and Tribal hospitals (collectively referred to here as 
``IHS hospitals'') to be subsection (d) hospitals, for the reasons 
discussed in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38188 through 
38189), we adopted a parallel adjustment at Sec.  412.101(e) which 
specifies that, for discharges occurring in FY 2018 and subsequent 
years, only the distance between IHS hospitals would be considered when 
assessing whether an IHS hospital meets the mileage criterion under 
Sec.  412.101(b)(2), and similarly, only the distance between non-IHS 
hospitals would be considered when assessing whether a non-IHS hospital 
meets the mileage criterion under Sec.  412.101(b)(2).
    While the policy finalized in the FY 2018 IPPS/LTCH PPS final rule 
addresses FY 2018 and subsequent fiscal years, section 429 of the 
Consolidated Appropriations Act, 2018 amended section 1886(d)(12)(C) of 
the Act by adding a new clause (iii) specifying that for purposes of 
determining whether an IHS or a non-IHS hospital meets the mileage 
criterion under section 1886(d)(12)(C)(i) of the Act with respect to FY 
2011 or a succeeding year, the Secretary shall apply the policy 
described in the regulations at Sec.  412.101(e) (as in effect on the 
date of enactment). In other words, under this statutory change, the 
special treatment with respect to the proximities between IHS and non-
IHS hospitals as set forth in Sec.  412.101(e) for discharges occurring 
in FY 2018 and subsequent fiscal years is now also applicable for 
purposes of applying the mileage criterion for the low-volume hospital 
payment adjustment for FYs 2011 through 2017. Therefore, when assessing 
the mileage criterion under Sec.  412.101(b)(2) for FYs 2011 through 
2017, an IHS hospital would be considered to have met the mileage 
criterion in the applicable year if it was more than 15 road miles from 
the nearest IHS hospital, and a non-IHS hospital would be considered to 
have met the mileage criterion in the applicable year if it was more 
than 15 road miles from the nearest non-IHS hospital.

B. Implementation of the Low-Volume Hospital Payment Adjustment Under 
Section 429 of the Consolidated Appropriations Act, 2018

    Section 429 of the Consolidated Appropriations Act, 2018 applies 
the policy at Sec.  412.101(e) to prior years, that is, for discharges 
occurring during FYs 2011 through 2017. To implement these changes, 
hospitals that qualify for the low-volume hospital payment adjustment 
under the provisions of the Consolidated Appropriations Act, 2018 may 
receive the low-volume hospital payment adjustment as part of the cost 
report settlement and reopening process for each cost report that 
includes discharges from one of the applicable fiscal years (that is, 
from FYs 2011 through 2017). In the event a hospital, having followed 
our process to request the low-volume hospital payment adjustment as 
described in this document, qualifies as a low-volume hospital for 
discharges occurring in one of the applicable fiscal years and those 
discharges are in a cost report that has been settled, the Medicare 
Administrative Contractors (MAC) will reopen such cost reports in 
accordance with 42 CFR 405.1885 which allows for the reopening of cost 
reports upon request only if a request to reopen is received by the MAC 
within 3 years of the date of the determination or decision that is the 
subject of the reopening or if the cost report is the subject of a 
pending jurisdictionally proper appeal before the Provider 
Reimbursement Review Board or CMS Administrator. Therefore, the 
application of the low-volume hospital payment adjustment under the 
provisions of section 429 of the Consolidated Appropriations Act, 2018 
will only be applied to discharges occurring in FYs 2011 through 2017 
(as applicable) that are in cost reports that are either currently open 
or for which the hospital requests reopening within the 3-year 
reopening period by making a request to the MAC with the information 
described in this document. In this document, we are explicitly 
directing the MACs to reopen and revise these matters, but only under 
the circumstances and for the cost reporting periods specified herein 
and subject to the time limits specified both in 42 CFR 405.1885(b) and 
this document. (See 42 CFR 405.1885(c)(1).) If a hospital's reopening 
request is untimely or if a hospital fails to provide adequate written 
documentation as described in this document, the MAC may deny the 
reopening request.
    We are directing a reopening here under the circumstances described 
solely in response to the amendment made by section 429 of the 
Consolidated Appropriations Act, 2018, which changed the application of 
the mileage criterion for purposes of the low-volume hospital payment 
adjustment for FYs 2011 through 2017. We reiterate here that, apart 
from the specific circumstances, time periods, and cost reporting 
periods for which we are explicitly directing reopening in this 
document, reopening denials by the MAC in this and other contexts are 
discretionary and unreviewable under Your Home Visiting Nurse Servs., 
Inc. v. Shalala, 525 U.S. 449 (1999) and related precedent.
    We note, any reopening under this procedure shall be for the sole 
purpose of making a low-volume hospital payment adjustment under the 
provisions of section 429 of the Consolidated Appropriations Act, 2018

[[Page 42598]]

and for no other purpose. (For additional information on the reopening 
regulations at 42 CFR 405.1885, refer to the following final rules 
published in the Federal Register: (67 FR 50096), (73 FR 30230), and 
(78 FR 75162) as well as sections 2931 through 2932 of chapter 29 of 
the Provider Reimbursement Manual (PRM), Part 1.)
    The changes to the low-volume hospital payment adjustment under 
section 429 of the Consolidated Appropriations Act, 2018 do not affect 
the discharge criterion in place between FYs 2011 and 2017. Thus, in 
accordance with the existing regulations at Sec.  412.101(b)(2)(ii) and 
consistent with our implementation of the low-volume hospital payment 
adjustment in FYs 2011 through 2017, the discharge data source used to 
identify qualifying low-volume hospitals and calculate the payment 
adjustment in accordance with the changes under section 429 of the 
Consolidated Appropriations Act, 2018 is the same discharge data source 
used to identify qualifying low-volume hospitals and calculate the 
payment adjustment for discharges that occurred in that fiscal year; 
that is, the most recent data available at the time of the development 
of the payment rates and factors established in the corresponding final 
rule. Under Sec.  412.101(b)(2)(ii), for FYs 2011 through 2017, a 
hospital's Medicare discharges from the most recently available MedPAR 
data for the applicable fiscal year, as determined by CMS, are used to 
determine whether the hospital meets the discharge criterion to receive 
the low-volume payment adjustment in the applicable year. The 
applicable low-volume percentage increase for FYs 2011 through 2017 is 
determined using a continuous linear sliding scale equation that 
results in a low-volume adjustment ranging from an additional 25 
percent for hospitals with 200 or fewer Medicare discharges to a zero 
percent additional payment adjustment for hospitals with 1,600 or more 
Medicare discharges (Sec.  412.101(c)(2)).
    For the discharge data source used to identify qualifying low-
volume hospitals and to calculate the payment adjustment for FY 2011, 
refer to the chart in the FY 2011 IPPS/LTCH PPS final rule (75 FR 50242 
through 50274) or the `Medicare Discharge Count for FY 2011 Low Volume 
Adjustment' file on the ``Files for FY 2011 Final Rule and Correction 
Notice'' home page (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Acute-Inpatient-Files-for-Download-Items/CMS1255464.html). For FYs 2012 through 2017, Table 14 of each 
year's respective IPPS/LTCH PPS final rule (which is available through 
the internet on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html under 
``Acute Inpatient--Files for Download'' for the respective year) lists 
the ``subsection (d)'' hospitals with fewer than 1,600 Medicare 
discharges based on the applicable data source and their payment 
adjustment for that fiscal year (if eligible).
    These discharges and corresponding payment adjustment are based on 
the most recent data available at the time of the development of that 
year's payment rates and factors established in the corresponding final 
rule. (For additional details on the discharge data source used to 
identify qualifying low-volume hospitals and calculate the payment 
adjustment for FYs 2011 through 2017, refer to the following FY 2011 
(75 FR 50241 through 50275); FY 2012 (76 FR 51679 through 51680); FY 
2013 (78 FR 14689 through 14691); FY 2014 ((79 FR 15022 through 15025) 
and (79 FR 34444 through 34446)); FY 2015 ((80 FR 49998 through 49999) 
and Change Request 9197 (Transmittal 3281; June 5, 2015)); FY 2016 (80 
FR 49595 through 49597); and FY 2017 (81 FR 56941 through 56943).) The 
list of hospitals with fewer than 1,600 Medicare discharges for each of 
FYs 2011 through 2017 (previously described) does not reflect whether 
or not the hospital meets the mileage criterion. In addition to meeting 
the discharge criterion, an IHS hospital would be eligible for the low-
volume hospital payment adjustment for an applicable fiscal year under 
the provisions of section 429 of the Consolidated Appropriations Act, 
2018 if, in the applicable fiscal year, it was located more than 15 
road miles from the nearest IHS hospital. Likewise, a non-IHS hospital 
meeting the discharge requirement would be eligible for the low-volume 
hospital payment adjustment for an applicable fiscal year under the 
provisions of section 429 of the Consolidated Appropriations Act, 2018 
if, in the applicable fiscal year, it was located more than 15 road 
miles from the nearest non-IHS hospital.
    We are using the following procedure for a hospital to request the 
low-volume hospital payment adjustment for any applicable fiscal years 
between FYs 2011 and 2017 under the provisions of section 429 of the 
Consolidated Appropriations Act, 2018. In order for the applicable low-
volume hospital payment adjustment to be applied for an applicable 
fiscal year's discharges in an open or reopenable cost report(s), a 
hospital must notify and provide documentation to its MAC in writing 
that it meets the mileage criterion under the provisions of section 429 
of the Consolidated Appropriations Act, 2018 in the applicable fiscal 
year (as described in this document). In the case of a reopenable cost 
report, the hospital must request a reopening when submitting its 
written notification and documentation to its MAC. We note, for a 
hospital to receive the low-volume payment adjustment in FYs 2011 
through 2017 under the provisions of the Consolidated Appropriations 
Act, 2018, the hospital must have been unable to meet the mileage 
criterion for that fiscal year prior to the enactment of the 
Consolidated Appropriations Act, 2018 (that is, the provisions of 
section 429 of the Consolidated Appropriations Act, 2018 do not affect 
hospitals which met the mileage criterion without regard to this 
provision). Specifically, for an IHS hospital to be eligible to receive 
the low-volume hospital payment adjustment in FYs 2011 through 2017 
under section 429 of the Consolidated Appropriations Act, 2018, that 
IHS hospital must not have been able to meet the mileage criterion in 
the applicable fiscal year based on its proximity to a non-IHS 
hospital. Similarly, for an non-IHS hospital to be eligible to receive 
the low-volume payment adjustment in FYs 2011 through 2017 under 
section 429 of the Consolidated Appropriations Act, 2018, that non-IHS 
hospital must not have been able to meet the mileage criterion in the 
applicable fiscal year based on its proximity to an IHS hospital. We 
encourage hospitals to notify their MAC as soon as possible because, as 
previously noted, under 42 CFR 405.1885, reopening a cost report is 
limited to 3 years after cost report settlement. In other words, the 
application of the low-volume hospital payment adjustment under the 
provisions of section 429 of the Consolidated Appropriations Act, 2018 
is limited to discharges occurring in FYs 2011 through 2017 (as 
applicable) that are in cost reports that are either currently open or 
within the 3-year reopening period. Therefore, to receive the low-
volume payment adjustment for discharges in FYs 2011 through 2017, the 
written request must be received by the MAC prior to the close of the 
3-year period for the cost report that includes such discharges.
    The use of a Web-based mapping tool as part of documenting that the 
hospital meets the mileage criterion for low-volume hospitals in the 
applicable fiscal year is acceptable. The MAC will determine if the 
information submitted by the hospital, such as the name and

[[Page 42599]]

street address of the nearest hospitals, location on a map, and 
distance (in road miles, as defined in the regulations at Sec.  
412.101(a)) from the hospital requesting low-volume hospital status, is 
sufficient to document that the hospital requesting low-volume hospital 
status meets the mileage criterion in the applicable fiscal year (and 
had previously been unable to meet the mileage criterion in that fiscal 
year as described in this document). The MAC may follow up with the 
hospital to obtain additional necessary information to determine 
whether or not the hospital meets the low-volume mileage criterion for 
any applicable fiscal year. In addition, the MAC will refer to the 
hospital's Medicare discharge data determined by CMS for the applicable 
fiscal year(s) to determine whether or not the hospital met the 
discharge criterion in that fiscal year, and the amount of the low-
volume hospital payment adjustment for such year(s), once it is 
determined that the mileage criterion has been met. (The applicable 
Medicare discharge data for each of FYs 2011 through 2017 is previously 
described.) In addition, in order to receive the low-volume hospital 
payment adjustment, sufficient documentation in the written request to 
the MAC must include the following to demonstrate that the hospital was 
unable to meet the mileage criterion for that fiscal year prior to the 
enactment of the Consolidated Appropriations Act, 2018. For each 
applicable fiscal year, an IHS hospital must provide documentation to 
its MAC that it was not able to meet the mileage criterion in the 
applicable fiscal year based on its proximity to a non-IHS hospital. 
Similarly, a non-IHS hospital must provide documentation to its MAC 
that it was not able to meet the mileage criterion in the applicable 
fiscal year based on its proximity to an IHS hospital.
    Program guidance on the implementation of this provision, including 
instructions for cost report settlement and reopening as applicable, 
will be announced in an upcoming transmittal. We intend to make any 
conforming changes to the regulations text at 42 CFR 412.101 to reflect 
the changes to the low-volume hospital payment adjustment policy in 
accordance with the amendments made by section 429 of the Consolidated 
Appropriations Act, 2018 as described in this document in future 
rulemaking.

III. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

IV. Regulatory Impact Statement

A. Statement of Need

    This document is necessary to update the low-volume hospital 
payment adjustment policy for FYs 2011 through 2017 to reflect changes 
provided by section 429 of the Consolidated Appropriations Act, 2018. 
Section 429 of the Consolidated Appropriations Act, 2018 makes certain 
changes to the payment adjustment for low-volume hospitals for FYs 2011 
through 2017 relating to the application of the mileage criterion for 
IHS and non-IHS hospitals.

B. Overall Impact Statement

    We have examined the impacts of this document as required by 
Executive Order 12866 on Regulatory Planning and Review (September 30, 
1993), Executive Order 13563 on Improving Regulation and Regulatory 
Review (January 18, 2011), the Regulatory Flexibility Act (RFA) 
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social 
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 
(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism 
(August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and 
Executive Order 13771 on Reducing Regulation and Controlling Regulatory 
Costs (January 30, 2017).
    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). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for regulatory 
actions with economically significant effects ($100 million or more in 
any 1 year). Although we do not consider this document to constitute a 
substantive rule or regulatory action, the monetary impact of the 
changes announced in this document is approximately a $40 million 
increase in low-volume hospital payments total for FYs 2011 through 
2017 relative to the estimates included in the respective FY IPPS/LTCH 
PPS final rules.

C. Anticipated Effects

    The RFA requires agencies to analyze options for regulatory relief 
of small businesses, if a rule has a significant impact on a 
substantial number of small entities. For purposes of the RFA, small 
entities include small businesses, nonprofit organizations, and small 
government jurisdictions. We estimate that most hospitals and most 
other providers and suppliers are small entities as that term is used 
in the RFA. The great majority of hospitals and most other health care 
providers and suppliers are small entities, either by being nonprofit 
organizations or by meeting the SBA definition of a small business 
(having revenues of less than $7.5 to $34.5 million in any 1 year). 
(For details on the latest standard for health care providers, we refer 
readers to page 33 of the Table of Small Business Size Standards for 
NAIC 622 at the Small Business Administration's website at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.) For 
purposes of the RFA, all hospitals and other providers and suppliers 
are considered to be small entities. Individuals and States are not 
included in the definition of a small entity. We note that we expect 
the effects of the changes announced in this document to impact only 
approximately 15 providers.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. With 
the exception of hospitals located in certain New England counties, for 
purposes of section 1102(b) of the Act, we now define a small rural 
hospital as a hospital that is located outside of an urban area and has 
fewer

[[Page 42600]]

than 100 beds. Section 601(g) of the Social Security Amendments of 1983 
(Pub. L. 98-21) designated hospitals in certain New England counties as 
belonging to the adjacent urban area. Thus, for purposes of the IPPS, 
we continue to classify these hospitals as urban hospitals. As noted 
previously, we expect the effects of the changes announced in this 
document to impact only approximately 15 providers.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 
(Pub. L. 104-4) also requires that agencies assess anticipated costs 
and benefits before issuing any rule whose mandates require spending in 
any 1 year of $100 million in 1995 dollars, updated annually for 
inflation. In 2018, that threshold is approximately $150 million. The 
changes announced in this document will not mandate any requirements 
for State, local, or tribal governments, nor will it affect private 
sector costs.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. The changes announced in this document will not have a 
substantial effect on State and local governments.
    Executive Order 13771, entitled ``Reducing Regulation and 
Controlling Regulatory Costs,'' was issued on January 30, 2017, and 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' It 
has been determined that the provisions announced in this document are 
actions that primarily result in transfers, and thus are not a 
regulatory or deregulatory action for the purposes of Executive Order 
13771.

V. Waiver of Proposed Rulemaking and Delay of Effective Date

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment prior to a rule taking 
effect in accordance with section 553(b) of the Administrative 
Procedure Act (APA) and section 1871 of the Act. In addition, in 
accordance with section 553(d) of the APA and section 1871(e)(1)(B)(i) 
of the Act, we ordinarily provide a 30 day delay to a substantive 
rule's effective date. For substantive rules that constitute major 
rules, in accordance with 5 U.S.C. 801, we ordinarily provide a 60-day 
delay in the effective date.
    None of the processes or effective date requirements apply, 
however, when the rule in question is interpretive, a general statement 
of policy, or a rule of agency organization, procedure or practice. 
They also do not apply when the statute establishes rules that are to 
be applied, leaving no discretion or gaps for an agency to fill in 
through rulemaking.
    In addition, an agency may waive notice and comment rulemaking, as 
well as any delay in effective date, when the agency for good cause 
finds that notice and public comment on the rule as well the effective 
date delay are impracticable, unnecessary, or contrary to the public 
interest. In cases where an agency finds good cause, the agency must 
incorporate a statement of this finding and its reasons in the rule 
issued.
    The policies being publicized in this document do not constitute 
agency rulemaking. Rather, the statute, as amended by the Consolidated 
Appropriations Act, 2018, has already required that the agency make 
these changes, and we are simply notifying the public of the changes to 
the payment adjustment for low-volume hospitals for FYs 2011 through 
2017 relating to the application of the mileage criterion for IHS and 
non-IHS hospitals. As this document merely informs the public of these 
changes, it is not a rule and does not require any notice and comment 
rulemaking. To the extent any of the policies articulated in this 
document constitute interpretations of the statute's requirements or 
procedures that will be used to implement the statute's directive, they 
are interpretive rules, general statements of policy, and rules of 
agency procedure or practice, which are not subject to notice and 
comment rulemaking or a delayed effective date.
    However, to the extent that notice and comment rulemaking, a delay 
in effective date, or both would otherwise apply, we find good cause to 
waive such requirements. Specifically, we find it unnecessary to 
undertake notice and comment rulemaking in this instance as this 
document does not propose to make any substantive changes to the 
policies or methodologies already in effect as a matter of law, but 
simply applies payment adjustments under the Consolidated 
Appropriations Act, 2018 to these existing policies and methodologies. 
As the changes outlined in this document have already taken effect, it 
would also be impracticable to undertake notice and comment rulemaking. 
For these reasons, we also find that a waiver of any delay in effective 
date, if it were otherwise applicable, is necessary to comply with the 
requirements of the Consolidated Appropriations Act, 2018. Therefore, 
we find good cause to waive notice and comment procedures as well as 
any delay in effective date, if such procedures or delays are required 
at all.

    Dated: August 16, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-18271 Filed 8-22-18; 8:45 am]
BILLING CODE 4120-01-P



                                             42596              Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Rules and Regulations

                                             List of Subjects in 40 CFR Part 52                          Dated: August 16, 2018.                                    Authority: 42 U.S.C. 7401 et seq.
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                                                                                                                                                                ■ 2. Amend § 52.1420(c) by revising the
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                                             organic compounds.                                        IMPLEMENTATION PLANS                                     *       *    *        *    *
                                                                                                                                                                    (c)* * *
                                                                                                       ■ 1. The authority citation for part 52
                                                                                                       continues to read as follows:

                                                                                                     EPA-APPROVED NEBRASKA REGULATIONS
                                              Nebraska cita-                                                     State effective
                                                                                     Title                                                    EPA Approval date                           Explanation
                                                  tion                                                                date

                                                                                                                      STATE OF NEBRASKA

                                                                                                               Department of Environmental Quality

                                                                                                       Title 129—Nebraska Air Quality Regulations


                                                      *                        *                   *                               *                   *                          *                     *
                                             129–20 ............   Particulate Emissions; Limitations                 5/13/2014     8/23/2018, [Insert Federal Reg-
                                                                     and Standards.                                                   ister citation].

                                                        *                        *                         *                       *                       *                      *                     *



                                             *      *       *       *      *                             Applicability date: The provisions                     regulations at 42 CFR 412.101. The
                                             [FR Doc. 2018–18103 Filed 8–22–18; 8:45 am]               described in this document are                           payment adjustment to a low-volume
                                             BILLING CODE 6560–50–P                                    applicable for discharges on or after                    hospital provided for under section
                                                                                                       October 1, 2010, and on or before                        1886(d)(12) of the Act is ‘‘[i]n addition
                                                                                                       September 30, 2017, in accordance with                   to any payment calculated under this
                                             DEPARTMENT OF HEALTH AND                                  section 429 of the Consolidated                          section.’’ Therefore, meaning the
                                             HUMAN SERVICES                                            Appropriations Act, 2018.                                payment adjustment is based on the per
                                                                                                       FOR FURTHER INFORMATION CONTACT:                         discharge amount paid to the qualifying
                                             Centers for Medicare & Medicaid                           Michele Hudson, (410) 786–5490.; Mark                    hospital under section 1886 of the Act.
                                             Services                                                  Luxton, (410) 786–4530.                                  In other words, the low-volume hospital
                                                                                                       SUPPLEMENTARY INFORMATION:                               payment adjustment is based on total
                                             42 CFR Part 412                                                                                                    per discharge payments made under
                                                                                                       I. Background                                            section 1886 of the Act, including
                                             [CMS–1709–N]
                                                                                                          On March 23, 2018 the Consolidated                    capital, disproportionate share hospital
                                             RIN 0938–ZB49                                                                                                      (DSH), indirect medical education
                                                                                                       Appropriations Act, 2018 (Pub. L. 115–
                                                                                                       141) was enacted. Section 429 of the                     (IME), and outlier payments. For sole
                                             Medicare Program; Certain Changes to                                                                               community hospitals (SCHs) and
                                             the Low-Volume Hospital Payment                           Consolidated Appropriations Act, 2018
                                                                                                       makes certain changes to the payment                     Medicare-dependent hospitals (MDHs),
                                             Adjustment Under the Hospital                                                                                      the low-volume hospital payment
                                             Inpatient Prospective Payment                             adjustment for low-volume hospitals for
                                                                                                       fiscal years (FYs) 2011 through 2017                     adjustment is based in part on either the
                                             Systems (IPPS) for Acute Care                                                                                      Federal rate or the hospital-specific rate,
                                             Hospitals for Fiscal Years 2011                           relating to the application of the mileage
                                                                                                       criterion for Indian Health Service and                  whichever results in a greater operating
                                             Through 2017                                                                                                       IPPS payment.
                                                                                                       non-Indian Health Service facilities.
                                             AGENCY: Centers for Medicare &                                                                                       The Affordable Care Act amended
                                             Medicaid Services (CMS), HHS.                             II. Provisions of the Document                           section 1886(d)(12) of the Act by
                                             ACTION: Application of a payment                          A. Changes to the Payment Adjustment                     modifying the definition of a low-
                                             adjustment.                                               for Low-Volume Hospitals in FYs 2011                     volume hospital and the methodology
                                                                                                       Through 2017                                             for calculating the payment adjustment
                                             SUMMARY:   This document announces                                                                                 for low-volume hospitals, effective only
                                             changes to the payment adjustment for                     1. Background                                            for discharges occurring during FYs
                                             low-volume hospitals under the hospital                     Section 1886(d)(12) of the Act                         2011 and 2012, and subsequent
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                                             inpatient prospective payment systems                     provides for an additional payment to                    legislation extended those temporary
                                             (IPPS) for acute care hospitals for fiscal                each qualifying low-volume hospital                      modifications through FY 2018. (The
                                             years (FYs) 2011 through 2017 in                          under the Hospital Inpatient Prospective                 most recent statutory extension of those
                                             accordance with section 429 of the                        Payment Systems (IPPS) for Acute Care                    temporary changes to the low-volume
                                             Consolidated Appropriations Act, 2018.                    Hospitals beginning in FY 2005. CMS                      hospital payment policy was for FY
                                             DATES: Effective date: August 22, 2018.                   implemented this provision in the                        2018 and is discussed in a document


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                                                              Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Rules and Regulations                                       42597

                                             (CMS 1677–N) that appeared in the                       considered when assessing whether an                  adjustment as described in this
                                             April 26, 2018 Federal Register (83 FR                  IHS hospital meets the mileage criterion              document, qualifies as a low-volume
                                             18301).) Specifically, those provisions                 under § 412.101(b)(2), and similarly,                 hospital for discharges occurring in one
                                             amended the qualifying criteria for low                 only the distance between non-IHS                     of the applicable fiscal years and those
                                             volume hospitals under section                          hospitals would be considered when                    discharges are in a cost report that has
                                             1886(d)(12)(C)(i) of the Act to specify                 assessing whether a non-IHS hospital                  been settled, the Medicare
                                             that, for FYs 2011 through 2018, a                      meets the mileage criterion under                     Administrative Contractors (MAC) will
                                             subsection (d) hospital qualifies as a                  § 412.101(b)(2).                                      reopen such cost reports in accordance
                                             low-volume hospital if it is more than                     While the policy finalized in the FY               with 42 CFR 405.1885 which allows for
                                             15 road miles from another subsection                   2018 IPPS/LTCH PPS final rule                         the reopening of cost reports upon
                                             (d) hospital and has less than 1,600                    addresses FY 2018 and subsequent                      request only if a request to reopen is
                                             discharges of individuals entitled to, or               fiscal years, section 429 of the                      received by the MAC within 3 years of
                                             enrolled for, benefits under Part A                     Consolidated Appropriations Act, 2018                 the date of the determination or
                                             during the fiscal year. In addition, these              amended section 1886(d)(12)(C) of the                 decision that is the subject of the
                                             provisions amended section                              Act by adding a new clause (iii)                      reopening or if the cost report is the
                                             1886(d)(12)(D) of the Act to provide that               specifying that for purposes of                       subject of a pending jurisdictionally
                                             for FYs 2011 through 2018, the low-                     determining whether an IHS or a non-                  proper appeal before the Provider
                                             volume hospital payment adjustment                      IHS hospital meets the mileage criterion              Reimbursement Review Board or CMS
                                             (that is, the percentage increase) is to be             under section 1886(d)(12)(C)(i) of the                Administrator. Therefore, the
                                             determined using a continuous linear                    Act with respect to FY 2011 or a                      application of the low-volume hospital
                                             sliding scale ranging from 25 percent for               succeeding year, the Secretary shall                  payment adjustment under the
                                             low-volume hospitals with 200 or fewer                  apply the policy described in the                     provisions of section 429 of the
                                             discharges of individuals entitled to, or               regulations at § 412.101(e) (as in effect             Consolidated Appropriations Act, 2018
                                             enrolled for, benefits under Part A in the              on the date of enactment). In other                   will only be applied to discharges
                                             fiscal year to zero percent for low-                    words, under this statutory change, the               occurring in FYs 2011 through 2017 (as
                                             volume hospitals with greater than                      special treatment with respect to the                 applicable) that are in cost reports that
                                             1,600 discharges of such individuals in                 proximities between IHS and non-IHS                   are either currently open or for which
                                             the fiscal year. (We note that under                    hospitals as set forth in § 412.101(e) for            the hospital requests reopening within
                                             § 412.101(b)(2)(ii), for FYs 2011 through               discharges occurring in FY 2018 and                   the 3-year reopening period by making
                                             2017, a hospital’s Medicare discharges                  subsequent fiscal years is now also                   a request to the MAC with the
                                             from the most recently available                        applicable for purposes of applying the               information described in this document.
                                             MedPAR data, as determined by CMS,                      mileage criterion for the low-volume                  In this document, we are explicitly
                                             are used to determine whether the                       hospital payment adjustment for FYs                   directing the MACs to reopen and revise
                                             hospital meets the discharge criterion to               2011 through 2017. Therefore, when                    these matters, but only under the
                                             receive the low volume hospital                         assessing the mileage criterion under                 circumstances and for the cost reporting
                                             payment adjustment in the applicable                    § 412.101(b)(2) for FYs 2011 through                  periods specified herein and subject to
                                             fiscal year. In the FY 2019 IPPS/LTCH                   2017, an IHS hospital would be                        the time limits specified both in 42 CFR
                                             PPS final rule, we finalized conforming                 considered to have met the mileage                    405.1885(b) and this document. (See 42
                                             changes to this provision to reflect that               criterion in the applicable year if it was            CFR 405.1885(c)(1).) If a hospital’s
                                             the low-volume hospital payment                         more than 15 road miles from the                      reopening request is untimely or if a
                                             adjustment policy in effect for FY 2018                 nearest IHS hospital, and a non-IHS                   hospital fails to provide adequate
                                             is the same low-volume hospital                         hospital would be considered to have                  written documentation as described in
                                             payment adjustment policy in effect for                 met the mileage criterion in the                      this document, the MAC may deny the
                                             FYs 2011 through 2017 (83 FR 41144,                     applicable year if it was more than 15                reopening request.
                                             August 17, 2018).                                       road miles from the nearest non-IHS                      We are directing a reopening here
                                                                                                     hospital.                                             under the circumstances described
                                             2. Treatment of Indian Health Service                                                                         solely in response to the amendment
                                             and Non-Indian Health Service                           B. Implementation of the Low-Volume
                                                                                                                                                           made by section 429 of the Consolidated
                                             Facilities                                              Hospital Payment Adjustment Under
                                                                                                                                                           Appropriations Act, 2018, which
                                                Section 1886(d)(12)(C) of the Act                    Section 429 of the Consolidated
                                                                                                                                                           changed the application of the mileage
                                             requires that, in order to qualify for the              Appropriations Act, 2018
                                                                                                                                                           criterion for purposes of the low-volume
                                             low volume hospital payment                                Section 429 of the Consolidated                    hospital payment adjustment for FYs
                                             adjustment, a hospital must be located                  Appropriations Act, 2018 applies the                  2011 through 2017. We reiterate here
                                             more than a specified number of miles                   policy at § 412.101(e) to prior years, that           that, apart from the specific
                                             from the nearest subsection (d) hospital                is, for discharges occurring during FYs               circumstances, time periods, and cost
                                             (referred to as the mileage criterion,                  2011 through 2017. To implement these                 reporting periods for which we are
                                             which is implemented at                                 changes, hospitals that qualify for the               explicitly directing reopening in this
                                             § 412.101(b)(2)). Since CMS considers                   low-volume hospital payment                           document, reopening denials by the
                                             Indian Health Service (IHS) and Tribal                  adjustment under the provisions of the                MAC in this and other contexts are
                                             hospitals (collectively referred to here as             Consolidated Appropriations Act, 2018                 discretionary and unreviewable under
                                             ‘‘IHS hospitals’’) to be subsection (d)                 may receive the low-volume hospital                   Your Home Visiting Nurse Servs., Inc. v.
                                             hospitals, for the reasons discussed in                 payment adjustment as part of the cost                Shalala, 525 U.S. 449 (1999) and related
                                             the FY 2018 IPPS/LTCH PPS final rule                    report settlement and reopening process
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                                                                                                                                                           precedent.
                                             (82 FR 38188 through 38189), we                         for each cost report that includes                       We note, any reopening under this
                                             adopted a parallel adjustment at                        discharges from one of the applicable                 procedure shall be for the sole purpose
                                             § 412.101(e) which specifies that, for                  fiscal years (that is, from FYs 2011                  of making a low-volume hospital
                                             discharges occurring in FY 2018 and                     through 2017). In the event a hospital,               payment adjustment under the
                                             subsequent years, only the distance                     having followed our process to request                provisions of section 429 of the
                                             between IHS hospitals would be                          the low-volume hospital payment                       Consolidated Appropriations Act, 2018


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                                             42598            Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Rules and Regulations

                                             and for no other purpose. (For                          final rule (which is available through                that it meets the mileage criterion under
                                             additional information on the reopening                 the internet on the CMS website at                    the provisions of section 429 of the
                                             regulations at 42 CFR 405.1885, refer to                https://www.cms.gov/Medicare/                         Consolidated Appropriations Act, 2018
                                             the following final rules published in                  Medicare-Fee-for-Service-Payment/                     in the applicable fiscal year (as
                                             the Federal Register: (67 FR 50096), (73                AcuteInpatientPPS/index.html under                    described in this document). In the case
                                             FR 30230), and (78 FR 75162) as well as                 ‘‘Acute Inpatient—Files for Download’’                of a reopenable cost report, the hospital
                                             sections 2931 through 2932 of chapter                   for the respective year) lists the                    must request a reopening when
                                             29 of the Provider Reimbursement                        ‘‘subsection (d)’’ hospitals with fewer               submitting its written notification and
                                             Manual (PRM), Part 1.)                                  than 1,600 Medicare discharges based                  documentation to its MAC. We note, for
                                                The changes to the low-volume                        on the applicable data source and their               a hospital to receive the low-volume
                                             hospital payment adjustment under                       payment adjustment for that fiscal year               payment adjustment in FYs 2011
                                             section 429 of the Consolidated                         (if eligible).                                        through 2017 under the provisions of
                                             Appropriations Act, 2018 do not affect                     These discharges and corresponding                 the Consolidated Appropriations Act,
                                             the discharge criterion in place between                payment adjustment are based on the                   2018, the hospital must have been
                                             FYs 2011 and 2017. Thus, in accordance                  most recent data available at the time of             unable to meet the mileage criterion for
                                             with the existing regulations at                        the development of that year’s payment                that fiscal year prior to the enactment of
                                             § 412.101(b)(2)(ii) and consistent with                 rates and factors established in the                  the Consolidated Appropriations Act,
                                             our implementation of the low-volume                    corresponding final rule. (For additional             2018 (that is, the provisions of section
                                             hospital payment adjustment in FYs                      details on the discharge data source                  429 of the Consolidated Appropriations
                                             2011 through 2017, the discharge data                   used to identify qualifying low-volume                Act, 2018 do not affect hospitals which
                                             source used to identify qualifying low-                 hospitals and calculate the payment                   met the mileage criterion without regard
                                             volume hospitals and calculate the                      adjustment for FYs 2011 through 2017,                 to this provision). Specifically, for an
                                             payment adjustment in accordance with                   refer to the following FY 2011 (75 FR                 IHS hospital to be eligible to receive the
                                             the changes under section 429 of the                    50241 through 50275); FY 2012 (76 FR                  low-volume hospital payment
                                             Consolidated Appropriations Act, 2018                   51679 through 51680); FY 2013 (78 FR                  adjustment in FYs 2011 through 2017
                                             is the same discharge data source used                  14689 through 14691); FY 2014 ((79 FR                 under section 429 of the Consolidated
                                             to identify qualifying low-volume                       15022 through 15025) and (79 FR 34444                 Appropriations Act, 2018, that IHS
                                             hospitals and calculate the payment                     through 34446)); FY 2015 ((80 FR 49998                hospital must not have been able to
                                             adjustment for discharges that occurred                 through 49999) and Change Request                     meet the mileage criterion in the
                                             in that fiscal year; that is, the most                  9197 (Transmittal 3281; June 5, 2015));               applicable fiscal year based on its
                                             recent data available at the time of the                FY 2016 (80 FR 49595 through 49597);                  proximity to a non-IHS hospital.
                                             development of the payment rates and                    and FY 2017 (81 FR 56941 through                      Similarly, for an non-IHS hospital to be
                                             factors established in the corresponding                56943).) The list of hospitals with fewer             eligible to receive the low-volume
                                             final rule. Under § 412.101(b)(2)(ii), for              than 1,600 Medicare discharges for each               payment adjustment in FYs 2011
                                             FYs 2011 through 2017, a hospital’s                     of FYs 2011 through 2017 (previously                  through 2017 under section 429 of the
                                             Medicare discharges from the most                       described) does not reflect whether or                Consolidated Appropriations Act, 2018,
                                             recently available MedPAR data for the                  not the hospital meets the mileage                    that non-IHS hospital must not have
                                             applicable fiscal year, as determined by                criterion. In addition to meeting the                 been able to meet the mileage criterion
                                             CMS, are used to determine whether the                  discharge criterion, an IHS hospital                  in the applicable fiscal year based on its
                                             hospital meets the discharge criterion to               would be eligible for the low-volume
                                                                                                                                                           proximity to an IHS hospital. We
                                             receive the low-volume payment                          hospital payment adjustment for an
                                                                                                                                                           encourage hospitals to notify their MAC
                                             adjustment in the applicable year. The                  applicable fiscal year under the
                                                                                                                                                           as soon as possible because, as
                                             applicable low-volume percentage                        provisions of section 429 of the
                                                                                                                                                           previously noted, under 42 CFR
                                             increase for FYs 2011 through 2017 is                   Consolidated Appropriations Act, 2018
                                                                                                                                                           405.1885, reopening a cost report is
                                             determined using a continuous linear                    if, in the applicable fiscal year, it was
                                                                                                                                                           limited to 3 years after cost report
                                             sliding scale equation that results in a                located more than 15 road miles from
                                                                                                                                                           settlement. In other words, the
                                             low-volume adjustment ranging from an                   the nearest IHS hospital. Likewise, a
                                                                                                                                                           application of the low-volume hospital
                                             additional 25 percent for hospitals with                non-IHS hospital meeting the discharge
                                                                                                                                                           payment adjustment under the
                                             200 or fewer Medicare discharges to a                   requirement would be eligible for the
                                             zero percent additional payment                         low-volume hospital payment                           provisions of section 429 of the
                                             adjustment for hospitals with 1,600 or                  adjustment for an applicable fiscal year              Consolidated Appropriations Act, 2018
                                             more Medicare discharges                                under the provisions of section 429 of                is limited to discharges occurring in FYs
                                             (§ 412.101(c)(2)).                                      the Consolidated Appropriations Act,                  2011 through 2017 (as applicable) that
                                                For the discharge data source used to                2018 if, in the applicable fiscal year, it            are in cost reports that are either
                                             identify qualifying low-volume                          was located more than 15 road miles                   currently open or within the 3-year
                                             hospitals and to calculate the payment                  from the nearest non-IHS hospital.                    reopening period. Therefore, to receive
                                             adjustment for FY 2011, refer to the                       We are using the following procedure               the low-volume payment adjustment for
                                             chart in the FY 2011 IPPS/LTCH PPS                      for a hospital to request the low-volume              discharges in FYs 2011 through 2017,
                                             final rule (75 FR 50242 through 50274)                  hospital payment adjustment for any                   the written request must be received by
                                             or the ‘Medicare Discharge Count for FY                 applicable fiscal years between FYs                   the MAC prior to the close of the 3-year
                                             2011 Low Volume Adjustment’ file on                     2011 and 2017 under the provisions of                 period for the cost report that includes
                                             the ‘‘Files for FY 2011 Final Rule and                  section 429 of the Consolidated                       such discharges.
                                                                                                                                                              The use of a Web-based mapping tool
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                                             Correction Notice’’ home page (https://                 Appropriations Act, 2018. In order for
                                             www.cms.gov/Medicare/Medicare-Fee-                      the applicable low-volume hospital                    as part of documenting that the hospital
                                             for-Service-Payment/AcuteInpatient                      payment adjustment to be applied for an               meets the mileage criterion for low-
                                             PPS/Acute-Inpatient-Files-for-                          applicable fiscal year’s discharges in an             volume hospitals in the applicable fiscal
                                             Download-Items/CMS1255464.html).                        open or reopenable cost report(s), a                  year is acceptable. The MAC will
                                             For FYs 2012 through 2017, Table 14 of                  hospital must notify and provide                      determine if the information submitted
                                             each year’s respective IPPS/LTCH PPS                    documentation to its MAC in writing                   by the hospital, such as the name and


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                                                              Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Rules and Regulations                                        42599

                                             street address of the nearest hospitals,                recordkeeping requirements.                           rights and obligations of recipients
                                             location on a map, and distance (in road                Consequently, it need not be reviewed                 thereof; or (4) raising novel legal or
                                             miles, as defined in the regulations at                 by the Office of Management and                       policy issues arising out of legal
                                             § 412.101(a)) from the hospital                         Budget under the authority of the                     mandates, the President’s priorities, or
                                             requesting low-volume hospital status,                  Paperwork Reduction Act of 1995 (44                   the principles set forth in the Executive
                                             is sufficient to document that the                      U.S.C. 35).                                           Order.
                                             hospital requesting low-volume hospital                                                                          A regulatory impact analysis (RIA)
                                             status meets the mileage criterion in the               IV. Regulatory Impact Statement                       must be prepared for regulatory actions
                                             applicable fiscal year (and had                         A. Statement of Need                                  with economically significant effects
                                             previously been unable to meet the                                                                            ($100 million or more in any 1 year).
                                                                                                       This document is necessary to update
                                             mileage criterion in that fiscal year as                                                                      Although we do not consider this
                                                                                                     the low-volume hospital payment
                                             described in this document). The MAC                                                                          document to constitute a substantive
                                                                                                     adjustment policy for FYs 2011 through                rule or regulatory action, the monetary
                                             may follow up with the hospital to
                                                                                                     2017 to reflect changes provided by                   impact of the changes announced in this
                                             obtain additional necessary information
                                                                                                     section 429 of the Consolidated                       document is approximately a $40
                                             to determine whether or not the hospital
                                                                                                     Appropriations Act, 2018. Section 429                 million increase in low-volume hospital
                                             meets the low-volume mileage criterion
                                                                                                     of the Consolidated Appropriations Act,               payments total for FYs 2011 through
                                             for any applicable fiscal year. In
                                                                                                     2018 makes certain changes to the                     2017 relative to the estimates included
                                             addition, the MAC will refer to the
                                                                                                     payment adjustment for low-volume                     in the respective FY IPPS/LTCH PPS
                                             hospital’s Medicare discharge data
                                                                                                     hospitals for FYs 2011 through 2017                   final rules.
                                             determined by CMS for the applicable
                                             fiscal year(s) to determine whether or                  relating to the application of the mileage
                                                                                                     criterion for IHS and non-IHS hospitals.              C. Anticipated Effects
                                             not the hospital met the discharge
                                             criterion in that fiscal year, and the                  B. Overall Impact Statement                              The RFA requires agencies to analyze
                                             amount of the low-volume hospital                                                                             options for regulatory relief of small
                                                                                                        We have examined the impacts of this               businesses, if a rule has a significant
                                             payment adjustment for such year(s),
                                                                                                     document as required by Executive                     impact on a substantial number of small
                                             once it is determined that the mileage
                                                                                                     Order 12866 on Regulatory Planning                    entities. For purposes of the RFA, small
                                             criterion has been met. (The applicable
                                                                                                     and Review (September 30, 1993),                      entities include small businesses,
                                             Medicare discharge data for each of FYs
                                                                                                     Executive Order 13563 on Improving                    nonprofit organizations, and small
                                             2011 through 2017 is previously
                                                                                                     Regulation and Regulatory Review                      government jurisdictions. We estimate
                                             described.) In addition, in order to
                                                                                                     (January 18, 2011), the Regulatory                    that most hospitals and most other
                                             receive the low-volume hospital
                                                                                                     Flexibility Act (RFA) (September 19,                  providers and suppliers are small
                                             payment adjustment, sufficient
                                                                                                     1980, Pub. L. 96–354), section 1102(b) of             entities as that term is used in the RFA.
                                             documentation in the written request to
                                             the MAC must include the following to                   the Social Security Act, section 202 of               The great majority of hospitals and most
                                             demonstrate that the hospital was                       the Unfunded Mandates Reform Act of                   other health care providers and
                                             unable to meet the mileage criterion for                1995 (March 22, 1995; Pub. L. 104–4),                 suppliers are small entities, either by
                                             that fiscal year prior to the enactment of              Executive Order 13132 on Federalism                   being nonprofit organizations or by
                                             the Consolidated Appropriations Act,                    (August 4, 1999), the Congressional                   meeting the SBA definition of a small
                                             2018. For each applicable fiscal year, an               Review Act (5 U.S.C. 804(2)), and                     business (having revenues of less than
                                             IHS hospital must provide                               Executive Order 13771 on Reducing                     $7.5 to $34.5 million in any 1 year). (For
                                             documentation to its MAC that it was                    Regulation and Controlling Regulatory                 details on the latest standard for health
                                             not able to meet the mileage criterion in               Costs (January 30, 2017).                             care providers, we refer readers to page
                                             the applicable fiscal year based on its                    Executive Orders 12866 and 13563                   33 of the Table of Small Business Size
                                             proximity to a non-IHS hospital.                        direct agencies to assess all costs and               Standards for NAIC 622 at the Small
                                             Similarly, a non-IHS hospital must                      benefits of available regulatory                      Business Administration’s website at
                                             provide documentation to its MAC that                   alternatives and, if regulation is                    https://www.sba.gov/sites/default/files/
                                             it was not able to meet the mileage                     necessary, to select regulatory                       files/Size_Standards_Table.pdf.) For
                                             criterion in the applicable fiscal year                 approaches that maximize net benefits                 purposes of the RFA, all hospitals and
                                             based on its proximity to an IHS                        (including potential economic,                        other providers and suppliers are
                                             hospital.                                               environmental, public health and safety               considered to be small entities.
                                                Program guidance on the                              effects, distributive impacts, and                    Individuals and States are not included
                                             implementation of this provision,                       equity). Section 3(f) of Executive Order              in the definition of a small entity. We
                                             including instructions for cost report                  12866 defines a ‘‘significant regulatory              note that we expect the effects of the
                                             settlement and reopening as applicable,                 action’’ as an action that is likely to               changes announced in this document to
                                             will be announced in an upcoming                        result in a rule: (1) Having an annual                impact only approximately 15
                                             transmittal. We intend to make any                      effect on the economy of $100 million                 providers.
                                             conforming changes to the regulations                   or more in any 1 year, or adversely and                  In addition, section 1102(b) of the Act
                                             text at 42 CFR 412.101 to reflect the                   materially affecting a sector of the                  requires us to prepare a regulatory
                                             changes to the low-volume hospital                      economy, productivity, competition,                   impact analysis if a rule may have a
                                             payment adjustment policy in                            jobs, the environment, public health or               significant impact on the operations of
                                             accordance with the amendments made                     safety, or state, local or tribal                     a substantial number of small rural
                                             by section 429 of the Consolidated                      governments or communities (also                      hospitals. This analysis must conform to
                                                                                                     referred to as ‘‘economically                         the provisions of section 604 of the
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                                             Appropriations Act, 2018 as described
                                             in this document in future rulemaking.                  significant’’); (2) creating a serious                RFA. With the exception of hospitals
                                                                                                     inconsistency or otherwise interfering                located in certain New England
                                             III. Collection of Information                          with an action taken or planned by                    counties, for purposes of section 1102(b)
                                             Requirements                                            another agency; (3) materially altering               of the Act, we now define a small rural
                                                This document does not impose                        the budgetary impacts of entitlement                  hospital as a hospital that is located
                                             information collection and                              grants, user fees, or loan programs or the            outside of an urban area and has fewer


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                                             42600            Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Rules and Regulations

                                             than 100 beds. Section 601(g) of the                       None of the processes or effective date            Appropriations Act, 2018. Therefore, we
                                             Social Security Amendments of 1983                      requirements apply, however, when the                 find good cause to waive notice and
                                             (Pub. L. 98–21) designated hospitals in                 rule in question is interpretive, a general           comment procedures as well as any
                                             certain New England counties as                         statement of policy, or a rule of agency              delay in effective date, if such
                                             belonging to the adjacent urban area.                   organization, procedure or practice.                  procedures or delays are required at all.
                                             Thus, for purposes of the IPPS, we                      They also do not apply when the statute                 Dated: August 16, 2018.
                                             continue to classify these hospitals as                 establishes rules that are to be applied,
                                                                                                                                                           Seema Verma,
                                             urban hospitals. As noted previously,                   leaving no discretion or gaps for an
                                                                                                                                                           Administrator, Centers for Medicare &
                                             we expect the effects of the changes                    agency to fill in through rulemaking.
                                                                                                                                                           Medicaid Services.
                                             announced in this document to impact                       In addition, an agency may waive
                                                                                                     notice and comment rulemaking, as well                [FR Doc. 2018–18271 Filed 8–22–18; 8:45 am]
                                             only approximately 15 providers.
                                                Section 202 of the Unfunded                          as any delay in effective date, when the              BILLING CODE 4120–01–P

                                             Mandates Reform Act of 1995 (UMRA)                      agency for good cause finds that notice
                                             (Pub. L. 104–4) also requires that                      and public comment on the rule as well
                                             agencies assess anticipated costs and                   the effective date delay are                          DEPARTMENT OF HOMELAND
                                             benefits before issuing any rule whose                  impracticable, unnecessary, or contrary               SECURITY
                                             mandates require spending in any 1 year                 to the public interest. In cases where an
                                             of $100 million in 1995 dollars, updated                agency finds good cause, the agency                   Federal Emergency Management
                                             annually for inflation. In 2018, that                   must incorporate a statement of this                  Agency
                                             threshold is approximately $150                         finding and its reasons in the rule
                                             million. The changes announced in this                  issued.                                               44 CFR Part 64
                                             document will not mandate any                              The policies being publicized in this
                                             requirements for State, local, or tribal                document do not constitute agency                     [Docket ID FEMA–2018–0002; Internal
                                                                                                     rulemaking. Rather, the statute, as                   Agency Docket No. FEMA–8543]
                                             governments, nor will it affect private
                                             sector costs.                                           amended by the Consolidated
                                                                                                                                                           Suspension of Community Eligibility
                                                Executive Order 13132 establishes                    Appropriations Act, 2018, has already
                                             certain requirements that an agency                     required that the agency make these                   AGENCY:  Federal Emergency
                                             must meet when it promulgates a                         changes, and we are simply notifying                  Management Agency, DHS.
                                             proposed rule (and subsequent final                     the public of the changes to the payment              ACTION: Final rule.
                                             rule) that imposes substantial direct                   adjustment for low-volume hospitals for
                                             requirement costs on State and local                    FYs 2011 through 2017 relating to the                 SUMMARY:    This rule identifies
                                             governments, preempts State law, or                     application of the mileage criterion for              communities where the sale of flood
                                             otherwise has Federalism implications.                  IHS and non-IHS hospitals. As this                    insurance has been authorized under
                                             The changes announced in this                           document merely informs the public of                 the National Flood Insurance Program
                                             document will not have a substantial                    these changes, it is not a rule and does              (NFIP) that are scheduled for
                                             effect on State and local governments.                  not require any notice and comment                    suspension on the effective dates listed
                                                Executive Order 13771, entitled                      rulemaking. To the extent any of the                  within this rule because of
                                             ‘‘Reducing Regulation and Controlling                   policies articulated in this document                 noncompliance with the floodplain
                                             Regulatory Costs,’’ was issued on                       constitute interpretations of the statute’s           management requirements of the
                                             January 30, 2017, and requires that the                 requirements or procedures that will be               program. If the Federal Emergency
                                             costs associated with significant new                   used to implement the statute’s                       Management Agency (FEMA) receives
                                             regulations ‘‘shall, to the extent                      directive, they are interpretive rules,               documentation that the community has
                                             permitted by law, be offset by the                      general statements of policy, and rules               adopted the required floodplain
                                             elimination of existing costs associated                of agency procedure or practice, which                management measures prior to the
                                             with at least two prior regulations.’’ It               are not subject to notice and comment                 effective suspension date given in this
                                             has been determined that the provisions                 rulemaking or a delayed effective date.               rule, the suspension will not occur and
                                             announced in this document are actions                     However, to the extent that notice and             a notice of this will be provided by
                                             that primarily result in transfers, and                 comment rulemaking, a delay in                        publication in the Federal Register on a
                                             thus are not a regulatory or deregulatory               effective date, or both would otherwise               subsequent date. Also, information
                                             action for the purposes of Executive                    apply, we find good cause to waive such               identifying the current participation
                                             Order 13771.                                            requirements. Specifically, we find it                status of a community can be obtained
                                                                                                     unnecessary to undertake notice and                   from FEMA’s Community Status Book
                                             V. Waiver of Proposed Rulemaking and                    comment rulemaking in this instance as
                                             Delay of Effective Date                                                                                       (CSB). The CSB is available at https://
                                                                                                     this document does not propose to make                www.fema.gov/national-flood-
                                               We ordinarily publish a notice of                     any substantive changes to the policies               insurance-program-community-status-
                                             proposed rulemaking in the Federal                      or methodologies already in effect as a               book.
                                             Register and invite public comment                      matter of law, but simply applies
                                             prior to a rule taking effect in                        payment adjustments under the                         DATES:  The effective date of each
                                             accordance with section 553(b) of the                   Consolidated Appropriations Act, 2018                 community’s scheduled suspension is
                                             Administrative Procedure Act (APA)                      to these existing policies and                        the third date (‘‘Susp.’’) listed in the
                                             and section 1871 of the Act. In addition,               methodologies. As the changes outlined                third column of the following tables.
                                             in accordance with section 553(d) of the                in this document have already taken                   FOR FURTHER INFORMATION CONTACT: If
                                             APA and section 1871(e)(1)(B)(i) of the                 effect, it would also be impracticable to             you want to determine whether a
daltland on DSKBBV9HB2PROD with RULES




                                             Act, we ordinarily provide a 30 day                     undertake notice and comment                          particular community was suspended
                                             delay to a substantive rule’s effective                 rulemaking. For these reasons, we also                on the suspension date or for further
                                             date. For substantive rules that                        find that a waiver of any delay in                    information, contact Adrienne L.
                                             constitute major rules, in accordance                   effective date, if it were otherwise                  Sheldon, PE, CFM, Federal Insurance
                                             with 5 U.S.C. 801, we ordinarily provide                applicable, is necessary to comply with               and Mitigation Administration, Federal
                                             a 60-day delay in the effective date.                   the requirements of the Consolidated                  Emergency Management Agency, 400 C


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Document Created: 2018-08-23 00:34:18
Document Modified: 2018-08-23 00:34:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionApplication of a payment adjustment.
DatesEffective date: August 22, 2018.
ContactMichele Hudson, (410) 786-5490.; Mark Luxton, (410) 786-4530.
FR Citation83 FR 42596 
RIN Number0938-ZB49

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