80_FR_75337 80 FR 75107 - Medicare Program; Inpatient Prospective Payment Systems; 0.2 Percent Reduction

80 FR 75107 - Medicare Program; Inpatient Prospective Payment Systems; 0.2 Percent Reduction

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

Federal Register Volume 80, Issue 230 (December 1, 2015)

Page Range75107-75117
FR Document2015-30486

In accordance with the Court's October 6, 2015 order in Shands Jacksonville Medical Center, Inc., et al. v. Burwell, No. 14-263 (D.D.C.) and consolidated cases that challenge the 0.2 percent reduction in inpatient prospective payment systems (IPPS) rates to account for the estimated $220 million in additional FY 2014 expenditures resulting from the 2-midnight policy, this notice discusses the basis for the 0.2 percent reduction and its underlying assumptions and invites comments on the same in order to facilitate our further consideration of the FY 2014 reduction. We will consider and respond to the comments received in response to this notice, and to comments already received on this issue in a final notice to be published by March 18, 2016.

Federal Register, Volume 80 Issue 230 (Tuesday, December 1, 2015)
[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)]
[Notices]
[Pages 75107-75117]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30486]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1658-NC]
RIN 0938-ZB23


Medicare Program; Inpatient Prospective Payment Systems; 0.2 
Percent Reduction

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

ACTION: Notice with comment period.

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

SUMMARY: In accordance with the Court's October 6, 2015 order in Shands 
Jacksonville Medical Center, Inc., et al. v. Burwell, No. 14-263 
(D.D.C.) and consolidated cases that challenge the 0.2 percent 
reduction in inpatient prospective payment systems (IPPS) rates to 
account for the estimated $220 million in additional FY 2014 
expenditures resulting from the 2-midnight policy, this notice 
discusses the basis for the 0.2 percent reduction and its underlying 
assumptions and invites comments on the same in order to facilitate our 
further consideration of the FY 2014 reduction. We will consider and 
respond to the comments received in response to this notice, and to 
comments already received on this issue in a final notice to be 
published by March 18, 2016.

DATES: Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
e.s.t. on February 2, 2016.

ADDRESSES: In commenting, refer to file code CMS-1658-NC. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
notice to http://www.regulations.gov. Follow the ``Submit a comment'' 
instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1658-NC, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1658-NC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Ing-Jye Cheng, (410) 786-2260 or Don 
Thompson, 410-786-6504.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following Web site as soon as possible after they have

[[Page 75108]]

been received: http://www.regulations.gov. Follow the search 
instructions on that Web site to view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. e.s.t. To schedule an appointment to view public 
comments, phone 1-800-743-3951.

I. Background

    In the final rule titled ``Medicare Program; Hospital Inpatient 
Prospective Payment Systems for the Acute Care Hospitals and the Long-
Term Care Hospital Prospective Payment System and Final Fiscal Year 
2014 Rates; Quality Reporting Requirements for Specific Providers; 
Hospital Conditions of Participation; Payment Policies Related to 
Patient Status'' (hereinafter referred to as the FY 2014 IPPS/LTCH PPS 
final rule), we adopted the 2-midnight policy effective October 1, 2013 
(78 FR 50906 through 50954). Under the 2-midnight policy, an inpatient 
admission is generally appropriate for Medicare Part A payment if the 
physician (or other qualified practitioner) admits the patient as an 
inpatient based upon the expectation that the patient will need 
hospital care that crosses at least 2 midnights. In assessing the 
expected duration of necessary care, the physician (or other 
practitioner) may take into account outpatient hospital care received 
prior to inpatient admission. If the patient is expected to need less 
than 2 midnights of care in the hospital, the services furnished should 
generally be billed as outpatient services. Our actuaries estimated 
that the 2-midnight policy would increase expenditures by approximately 
$220 million in FY 2014 due to an expected net increase in inpatient 
encounters. We used our authority under section 1886(d)(5)(I)(i) of the 
Act to make a reduction of 0.2 percent to the standardized amount, the 
Puerto Rico standardized amount, and the hospital-specific payment 
rate, and we used our authority under section 1886(g) of the Act to 
make a reduction of 0.2 percent to the national capital Federal rate 
and the Puerto Rico-specific capital rate, in order to offset this 
estimated $220 million in additional IPPS expenditures in FY 2014. (In 
addition to an operating IPPS payment for each discharge, hospitals 
also receive a capital IPPS payment for each discharge so a net 
increase in the number of inpatient encounters also results in 
increased expenditures under the capital IPPS.)

II. Supplemental Notice Requesting Comments on the FY 2014 IPPS Rule

A. Overview

    As noted in section I. of this notice with comment period, we 
estimated based on an actuarial model that the 2-midnight policy would 
increase IPPS expenditures by approximately $220 million in FY 2014 due 
to an expected net increase in inpatient encounters, as described in 
greater detail in an August 19, 2013 memorandum. (See Appendix A of 
this notice.)
    Section II.B. of this notice with comment period provides 
additional details on the calculation of this estimate (that is, what 
we did) and section II.C. of this notice with comment period discusses 
the actuaries' assumptions, including why those assumptions were 
reasonable. We collectively refer to the calculations and assumptions 
as the actuarial ``model'' for estimating the financial impact of the 
policy change. Section II.D. of this notice with comment period 
discusses the status of an analysis currently being conducted by our 
actuaries of the claims experience since the implementation of the 2-
midnight policy. We seek comment on all aspects of the model used by 
our actuaries, including but not limited to those for which we 
specifically request comment. We seek comment on, and will consider 
comments on, all aspects of the 0.2 percent reduction.

B. Calculation of the Impact of the 2-Midnight Policy

    The task of modeling the impact of the 2-midnight policy on 
hospital payments begins with a recognition that some cases that were 
previously outpatient cases will become inpatient cases and vice versa. 
Therefore, our actuaries were required to develop a model that 
determined the net effect of the number of cases that would move in 
each direction.
    In estimating the number of outpatient cases that would shift to 
the inpatient setting, we analyzed calendar year (CY) 2011 claims that 
included spending for observation care or a major procedure. For the 
purposes of the -0.2 percent estimate, CMS physicians defined 
observation care as Outpatient Prospective Payment System (OPPS) claims 
containing Healthcare Common Procedure Coding System (HCPCS) code 
``G0378'', Hospital observation service, per hour, or HCPCS code 
``G0379'' Direct admission of patient for hospital observation care. We 
used the difference between the first date of service for the HCPCS 
code (generally the first date that the service represented by that 
code was provided to the patient) and the ``claim through'' date 
(generally the last date any service on the claim was provided to the 
patient) to determine the length of the observation care. In this 
manner, we identified approximately 350,000 observation care stays of 2 
midnights or more using the CY 2011 claims.
    A list of the Ambulatory Payment Classifications (APCs) containing 
the major procedures used in the determination of the -0.2 percent 
estimate can be found in Appendix B of this notice with comment period. 
As with observation care, the difference between the first date of 
service for the HCPCS code and the claim through date was used to 
determine the length of the major procedure. We identified 
approximately 50,000 claims containing major procedures with stays 
lasting 2 midnights or more using the CY 2011 claims.
    Combining the observation care and the major procedures resulted in 
approximately 400,000 claims for services of 2 midnights or more from 
the CY 2011 claims data.
    For additional details on the identification of the outpatient 
claims, see Appendix C of this notice with comment period.
    In estimating the number of inpatient stays that would shift to the 
outpatient setting, FY 2011 inpatient claims containing a surgical 
Medicare Severity Diagnosis Related Group (MS-DRG) were analyzed. The 
number of these stays that spanned less than 2 midnights, based on the 
length of stay, was approximately 360,000. FY 2009 and FY 2010 data 
were also analyzed and the results were consistent with the FY 2011 
results.
    For additional details on the identification of the inpatient 
claims, see Appendix D of this notice with comment period.
    Our actuaries also assumed that payment under the OPPS would be 30 
percent of the payment under the IPPS for encounters shifting between 
the two systems, and that the beneficiary is responsible for 20 percent 
of the Part B cost.
    The number of short stay discharges (for this purpose, same day 
discharges and discharges crossing one or two midnights) represented 
about 28 percent of total discharges in FY 2011, and approximately 17 
percent of total spending for the total discharges. The assumed net 
increase of 40,000

[[Page 75109]]

inpatient discharges (= 400,000 OPPS to IPPS--360,000 IPPS to OPPS) 
represented an increase of 1.2 percent in the number of short stay 
discharges. Taking 1.2 percent of 17 percent of total spending results 
in the estimate at the time of the FY 2014 IPPS/LTCH PPS rulemaking 
that the 2-midnight policy would result in an additional $290 million 
in inpatient expenditures, as shown for FY 2014 in the table ``Impact 
on Medicare Expenditures'' found in the memorandum in Appendix A of 
this notice. The estimates for the additional inpatient expenditures 
for FYs 2015 through 2018 can also be found in the table (for example, 
$320 million for FY 2015).
    For the outpatient expenditure estimate, taking 30 percent (based 
on the assumption that payment under the OPPS would be 30 percent of 
the payment under the IPPS) of 80 percent (to account for the assumed 
20 percent beneficiary responsibility) of the $290 million inpatient 
estimate results in approximately $70 million less outpatient 
expenditures. The estimates for the reduction in outpatient 
expenditures for FYs 2015 through 2018 can also be found in the table 
(For example, $80 million for FY 2015.)
    The estimated $290 million increase in inpatient expenditures less 
the estimated $70 million decrease in outpatient expenditures yields 
the estimated net impact by our actuaries at the time of the FY 2014 
IPPS/LTCH PPS rulemaking of an additional $220 million in expenditures 
in FY 2014 as a result of the 2-midnight policy. The estimated 
additional expenditures for FYs 2015 through 2018 can be similarly 
calculated.
    Using the information contained in this section and the appendices 
to this notice, interested members of the public should be able to 
calculate the estimate by our actuaries of an additional $220 million 
in expenditures in FY 2014 as a result of the 2-midnight policy. (For 
interested members of the public who wish to perform this calculation, 
we highlight the discussion in Appendix D regarding the number of 
inpatient cases identified in the MedPAR data and the Integrated Data 
Repository.)

C. Discussion of the Assumptions Made in the Calculation of the Impact 
of the 2-Midnight Policy

    As our actuaries stated in the August 2013 memorandum, the 
estimates depend critically on the assumed utilization changes in the 
inpatient and outpatient hospital settings. We discuss the assumptions 
underlying the estimates further in this section.
1. Estimated Outpatient Cases That Would Shift to the Inpatient Setting
    As indicated previously, in estimating the number of outpatient 
cases that would shift to the inpatient setting, CY 2011 claims that 
included spending for observation care or a major procedure were 
analyzed. This was done in order to remove claims with diagnostic 
services or minor procedures that would be less likely to trigger an 
encounter in which there was a continuous stay. (See the discussion in 
Appendix C of this notice with comment period.)
    For the purpose of the -0.2 percent estimate, observation care was 
defined as OPPS claims containing HCPCS ``G0378,'' Hospital observation 
service, per hour, or ``G0379'' Direct admission of patient for 
hospital observation care. At the time the -0.2 percent estimate was 
being developed, we were also examining establishing comprehensive APCs 
under the OPPS (for a summary of the results of this examination see 
the CY 2014 OPPS proposed rule (78 FR 43540)). One of the claims 
analyses that we developed for this purpose included service counts of 
G0378 and G0379 and significant procedures. Since this analysis 
included the universe of services of interest for the 2-midnight policy 
at that time, it was well-suited for use in the development of the -0.2 
percent estimate as well. For a discussion of the data specifications 
for this claims analysis, and how it was subset for the 2-midnight 
analysis, see Appendix C of this notice with comment period.
    However, in retrospect, using HCPCS G0378 and G0379 may have been 
an overly conservative definition of observation services, because not 
every use of observation services would be captured by the G-codes. As 
indicated in the Medicare Claims Processing Manual,\1\ hospitals are 
required to report observation charges under the revenue center code 
``0760'', Treatment or observation room--general classification, or 
``0762'' Treatment or observation room--observation room regardless of 
whether or not the G-codes are billed.
---------------------------------------------------------------------------

    \1\ See section 290.2.1 in Chapter 4 of the Medicare Claims 
Processing Manual available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c04.pdf)
---------------------------------------------------------------------------

    We also note that the Office of the Inspector General (OIG) used 
this revenue center code definition of observation services in its 
report ``Hospitals' Use of Observation Stays and Short Inpatient Stays 
\2\ (OEI-02-12-00040).
---------------------------------------------------------------------------

    \2\ Available at http://oig.hhs.gov/oei/reports/oei-02-12-00040.pdf.
---------------------------------------------------------------------------

    If we had defined observation services using revenue center codes 
0760 and 0762 instead of HCPCS codes G0378 and G0379, we would have 
identified approximately 400,000 claims for observation services 
spanning 2 midnights or more (instead of 350,000) and we would have 
estimated approximately 450,000 cases shifting from the outpatient to 
the inpatient setting (400,000 claims for observation stays spanning 
more than 2 midnights and approximately 50,000 claims for major 
procedures) instead of the 400,000 cases used in the estimate. We seek 
comment on whether it would be more appropriate to define observation 
services using revenue center codes 0760 and 0762 rather than HCPCS 
codes G0378 and G0379.
    Another consequence of the use of the claims analyses that we 
developed for the purpose of the comprehensive APCs involves the 
approach used to determine whether observation stays spanned 2 
midnights or more. In general, in the claims analysis for comprehensive 
APC development, we examined the difference between the date of service 
for the primary HCPCS code on the claim and the claim through date. For 
the observation services in this analysis, we used the difference 
between first date of service for the observation service and the claim 
through date to determine the length of the observation case. However, 
in retrospect, as with the definition of observation services, this may 
have been an overly conservative approach to determining the length of 
the observation case. Under the 2-midnight policy, for purposes of 
determining whether the 2 midnight benchmark was met and, therefore, 
whether inpatient admission was generally appropriate, the expected 
duration of care includes the time the beneficiary spent receiving 
outpatient services within the hospital. This includes services such as 
observation services, treatments in the emergency department, and 
procedures provided in the operating room or other treatment area. It 
is not just the time spent receiving observation services. As such, it 
may have been more appropriate to have used the ``claim from'' date (in 
general the date that the beneficiary entered the hospital), rather 
than the first date that observation services were provided in order to 
determine when claims containing observation services spanned 2 
midnights or more. If we had used such an approach when developing the 
original estimate, instead of approximately 350,000 claims with 
observation services spanning 2

[[Page 75110]]

midnights or more, the estimate would have been approximately 430,000 
claims under the HCPCS code G0378/G0370 definition of observation 
services and approximately 520,000 under the revenue center code 0760/
0762 definition of observation services. When combined with our 
estimate of major procedures, we would have estimated as many as 
570,000 cases shifting from the outpatient to the inpatient setting 
under this approach instead of the 400,000 cases used in the estimate. 
We seek comment on whether it would be more appropriate to have used 
the claim from date rather than the first date that observation 
services were provided in order to determine when claims containing 
observation services spanned 2 midnights or more.
2. Estimated Inpatient Cases That Would Shift to the Outpatient Setting
    We believed some proportion of the inpatient cases under 2 
midnights in the historical data would remain inpatient because we 
believed that behavioral changes by hospitals and admitting 
practitioners would mitigate some of the impact of cases shifting 
between the inpatient hospital setting and the outpatient hospital 
setting. The question was how to reasonably estimate what that 
proportion would be for purposes of modelling the impact of the 2-
midnight policy. We believe that a model distinguishing between medical 
and surgical cases is a reasonable approach to use in determining what 
proportion of inpatient cases would remain in the inpatient setting and 
what proportion would shift to the outpatient setting.
    Specifically, in estimating the number of inpatient stays that 
would shift to the outpatient setting, FY 2011 inpatient claims 
containing a surgical MS-DRG were analyzed. Our actuaries assumed that 
those spanning less than 2 midnights (other than those stays that were 
cut short by a death or transfer) would shift from the inpatient 
setting to the outpatient setting. Stays that were cut short by a death 
or transfer were excluded because under the 2-midnight policy those 
cases would generally be considered to be appropriately treated on an 
inpatient basis. (For a discussion of the data specifications for the 
inpatient claims analysis, see Appendix D of this notice.)
    Claims containing medical MS-DRGs were excluded because, as stated 
in the August 2013 memorandum, ``it was assumed that these cases would 
be unaffected by the policy change.'' Our actuaries excluded medical 
MS-DRGs when developing the -0.2 percent estimate because they believed 
that due to behavioral changes by hospitals and admitting practitioners 
most inpatient medical encounters spanning less than 2 midnights before 
the current 2-midnight policy was implemented might be reasonably 
expected to extend past 2 midnights after its implementation and would 
thus still be considered inpatient. They believed that the clinical 
assessments and protocols used by physicians to develop an expected 
length of stay for medical cases were, in general, more variable and 
less defined than those used to develop an expected length of stay for 
surgical cases.
    Evidence of this medical/surgical dichotomy is seen in proprietary 
utilization review tools such as the Milliman Care Guidelines, which 
are guidelines based originally on actuarial data, and InterQual, which 
are clinically oriented guidelines. Both tools reflect the same types 
of distinctions between medical and surgical cases that we assumed 
based on CMS medical staff's clinical judgment. Although all 
guidelines, and all surgeons, advise patients that individual patients 
vary in their post-operative courses, there are predictable post-
operative courses that are based on such factors as whether or not the 
abdominal cavity or the pleural cavity are entered, the expected time 
for recovery from anesthesia, the expected time to resume urinary 
function, the expected time to resume bowel function, the expected time 
to regain mobility, and the typical period for common post-operative 
interventions. These are by no means absolute but are fairly well-
defined, as evidenced by the surgeon's ability to generally inform the 
patient, within a day or so, how long the patient probably can expect 
to remain in the hospital if treatment goes well. Part of this 
decreased variance is due to the fact that the reason for admission, a 
specific surgical procedure, is well-defined.
    Conversely, for medical admissions a single diagnosis typically 
covers a much broader spectrum of possibilities. Pneumonia may have 
different etiologies, with vastly different expected lengths of stay. A 
stroke may be minor, allowing a brief diagnostic workup to be followed 
by outpatient rehabilitation, or catastrophic, triggering a prolonged 
stay before stabilization and discharge. Chronic obstructive pulmonary 
disease (COPD) and congestive heart failure (CHF) may respond rapidly 
to medication adjustments or may result in Intense Care Unit (ICU) 
stays. Unlike the surgical procedure, the medical diagnosis does not 
imply a reasonably consistent set of activities. In fact, typical 
medical protocols are highly branched, with the initial portion of 
hospital care typically focused on diagnostics that serve to 
differentiate patient subsets that define treatments and simultaneously 
suggest different hospital courses. The increased variability in the 
medical protocols is influenced by the fact that, for planned surgical 
admissions, more of the branching takes place in the process of 
selecting a specific surgical intervention before the patient is 
admitted, while for medical admissions more of the branching takes 
place after admission.
    For these reasons, the clinical judgment of CMS's medical staff 
supports our actuaries' estimate of the impact of the 2-midnight policy 
on program payments to hospitals.
3. Estimated IPPS/OPPS Cost Difference for Cases That Shift Between the 
IPPS and OPPS
    Our actuaries assumed that the OPPS cost for services that shift 
between the OPPS and IPPS was 30 percent of the IPPS cost, and the 
beneficiary is responsible for 20 percent of the OPPS cost. The 30 
percent is an assumption about the difference on average. While payment 
under the OPPS is on average less than payment under the IPPS for these 
cases, the key question is how much less on average? For any given 
case, the payment differential will vary. We note that when the OIG 
examined the payment differential between short inpatient stays and 
observation stays in their 2013 report ``Hospitals' Use of Observation 
Stays and Short Inpatient Stays for Medicare Beneficiaries'' (OEI-02-
12-00040), it found that on average Medicare paid nearly three times 
more for a short inpatient stay than an observation stay (p. 12). This 
is consistent with the 30 percent estimate used in the development of 
the -0.2 percent estimate. We seek comment on whether it is appropriate 
to utilize a 30 percent estimate.

D. Claims Experience Since the Implementation of the 2-Midnight Policy

    Our actuaries are currently conducting an analysis of claims 
experience for FY 2014 and FY 2015 in light of available data, 
including the MedPAR data. Because that analysis is not yet complete, 
we are not proposing in this notice with comment period to reconsider 
the 0.2 percent reduction in the FY 2014 IPPS/LTCH PPS final rule based 
on the results of the claims analysis. However, we are seeking comment 
on whether we should await the completion of the actuaries' analysis of 
FY 2014 and FY 2015 data before resolution of this proceeding.

[[Page 75111]]

    We note that any potential model revisions do not necessarily mean 
that the net result of the initial modelling, namely the ultimate -0.2 
percent adjustment, was incorrect. As we have indicated since the -0.2 
percent estimate was developed, the assumptions used for purposes of 
reasonably estimating overall impacts cannot be construed as absolute 
statements about every individual encounter. Under the original 2-
midnight policy, our actuaries did not expect that every single 
surgical MS-DRG encounter spanning less than 2 midnights would shift to 
the outpatient setting, that every single medical MS-DRG encounter 
would remain in the inpatient setting, and that every single outpatient 
observation stay or major surgical encounter spanning more than 2 
midnights would shift to the inpatient setting. However, for purposes 
of developing the -0.2 percent adjustment estimate under the original 
policy, a model where cases involving a surgical MS-DRG spanning less 
than 2 midnights in the historical data shifted to the outpatient 
setting, cases involving a medical MS-DRG spanning less than 2 
midnights in the historical data remained in the inpatient setting, and 
outpatient observation stays and major surgical encounters spanning 
more than 2 midnights in the historical data shifted to the inpatient 
setting yielded a reasonable estimate of the net effect of the 2-
midnight policy when it was adopted. To the extent the actual 
experience might vary for each of the individual assumptions, our 
actuaries estimated that the total net effect of that variation would 
not significantly impact the estimate.
    There were also factors that could not be anticipated at the time 
of the initial modelling that may influence the actual experience, such 
as the prohibition on Recovery Auditor post-payment reviews that became 
effective October 1, 2013. This prohibition might have affected 
hospital behavior in unexpected ways.
    Our actuaries will continue to review the claims experience for FY 
2014 and subsequent years under the 2-midnight policy to evaluate the 
assumptions underlying the original estimate. As we indicated in the CY 
2016 OPPS/ASC final rule, we will take the reviews into account during 
future rulemaking, including potential future rulemaking on the issue 
of whether or not the policy change that we adopted for the medical 
review of inpatient hospital admissions under Medicare Part A described 
in the CY 2016 OPPS final rule will have a differential impact on 
expenditures compared to the original policy. Although our analysis of 
the historical data since the implementation of the 2-midnight policy 
is not yet complete, and we do not propose to reconsider the reduction 
in light of that analysis at this time, we are including this 
discussion in this notice because we received many comments on the CY 
2016 OPPS proposed rule asserting that the claims data since the 
adoption of the original 2-midnight policy is inconsistent with our 
original -0.2 percent estimate. We continue to invite comment on this 
issue. As indicated in the CY 2016 OPPS final rule, we intend to 
respond to all public comments regarding the validity of the original -
0.2 percent adjustment that we received in response to the CY 2016 OPPS 
proposed rule as part of these Shands remand proceedings and publish a 
final notice by March 18, 2016.
    We elected to promulgate the -0.2 percent adjustment for the 
reasons described in the FY 2014 IPPS/LTCH PPS proposed and final rules 
and elaborated upon in this notice with comment period. We request 
comment on all aspects of that decision, including but not limited to 
the information, assumptions, and analyses supporting the adjustment.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the ``DATES'' section of this 
preamble, and, when we proceed with a subsequent document, we will 
respond to the comments in the preamble to that document.

    Dated: November 20, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: November 24, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.

[[Page 75112]]

Appendix A

BILLING CODE 4120-01-C
[GRAPHIC] [TIFF OMITTED] TN01DE15.062


[[Page 75113]]


[GRAPHIC] [TIFF OMITTED] TN01DE15.063


[[Page 75114]]


[GRAPHIC] [TIFF OMITTED] TN01DE15.064

BILLING CODE 4120-01-P

[[Page 75115]]

Appendix B

List of APCs Containing Major Procedures For Purposes of the 2 Midnight 
Estimate

APC--APC Description
0005--Level II Needle Biopsy/Aspiration Except Bone Marrow
0007--Level II Incision & Drainage
0008--Level III Incision and Drainage
0012--Level I Debridement & Destruction
0017--Level V Debridement & Destruction
0019--Level I Excision/Biopsy
0020--Level II Excision/Biopsy
0021--Level III Excision/Biopsy
0022--Level IV Excision/Biopsy
0028--Level I Breast Surgery
0029--Level II Breast Surgery
0030--Level III Breast Surgery
0037--Level IV Needle Biopsy/Aspiration Except Bone Marrow
0041-- Arthroscopy
0042--Level II Arthroscopy
0045--Bone/Joint Manipulation Under Anesthesia
0047--Arthroplasty without Prosthesis
0048--Level I Arthroplasty or Implantation with Prosthesis
0049--Level I Musculoskeletal Procedures Except Hand and Foot
0050--Level II Musculoskeletal Procedures Except Hand and Foot
0051--Level III Musculoskeletal Procedures Except Hand and Foot
0052--Level IV Musculoskeletal Procedures Except Hand and Foot
0053--Level I Hand Musculoskeletal Procedures
0054--Level II Hand Musculoskeletal Procedures
0055--Level I Foot Musculoskeletal Procedures
0056--Level II Foot Musculoskeletal Procedures
0057--Bunion Procedures
0062--Level I Treatment Fracture/Dislocation
0063--Level II Treatment Fracture/Dislocation
0064--Level III Treatment Fracture/Dislocation
0069--Thoracoscopy
0074--Level IV Endoscopy Upper Airway
0075--Level V Endoscopy Upper Airway
0076--Level I Endoscopy Lower Airway
0080--Diagnostic Cardiac Catheterization
0082--Coronary or Non-Coronary Atherectomy
0083--Coronary Angioplasty, Valvuloplasty, and Level I Endovascular 
Revascularization
0085--Level II Electrophysiologic Procedures
0086--Level III Electrophysiologic Procedures
0088--Thrombectomy
0089--Insertion/Replacement of Permanent Pacemaker and Electrodes
0090--Level I Insertion/Replacement of Permanent Pacemaker
0091--Level II Vascular Ligation
0092--Level I Vascular Ligation
0093--Vascular Reconstruction/Fistula Repair without Device
0103--Miscellaneous Vascular Procedures
0104--Transcatheter Placement of Intracoronary Stents
0105--Repair/Revision/Removal of Pacemakers, AICDs, or Vascular Devices
0106--Insertion/Replacement of Pacemaker Leads and/or Electrodes
0107--Insertion of Cardioverter-Defibrillator Pulse Generator
0108--Insertion/Replacement/Repair of Cardioverter-Defibrillator System
0113--Excision Lymphatic System
0114--Thyroid/Lymphadenectomy Procedures
0115--Cannula/Access Device Procedures
0121--Level I Tube or Catheter Changes or Repositioning
0130--Level I Laparoscopy
0131--Level II Laparoscopy
0132--Level III Laparoscopy
0135--Level III Skin Repair
0136--Level IV Skin Repair
0137--Level V Skin Repair
0148--Level I Anal/Rectal Procedures
0149--Level III Anal/Rectal Procedures
0150--Level IV Anal/Rectal Procedures
0152--Level I Percutaneous Abdominal and Biliary Procedures
0153--Peritoneal and Abdominal Procedures
0154--Hernia/Hydrocele Procedures
0160--Level I Cystourethroscopy and other Genitourinary Procedures
0161--Level II Cystourethroscopy and other Genitourinary Procedures
0162--Level III Cystourethroscopy and other Genitourinary Procedures
0163--Level IV Cystourethroscopy and other Genitourinary Procedures
0166--Level I Urethral Procedures
0168--Level II Urethral Procedures
0169--Lithotripsy
0174--Level IV Laparoscopy
0181--Level II Male Genital Procedures
0183--Level I Male Genital Procedures
0184--Prostate Biopsy
0190--Level I Hysteroscopy
0192--Level IV Female Reproductive Proc
0193--Level V Female Reproductive Proc
0195--Level VI Female Reproductive Procedures
0202--Level VII Female Reproductive Procedures
0208--Laminotomies and Laminectomies
0220--Level I Nerve Procedures
0221--Level II Nerve Procedures
0224--Implantation of Catheter/Reservoir/Shunt
0227--Implantation of Drug Infusion Device
0229--Level II Endovascular Revascularization of the Lower Extremity
0233--Level III Anterior Segment Eye Procedures
0234--Level IV Anterior Segment Eye Procedures
0237--Level II Posterior Segment Eye Procedures
0238--Level I Repair and Plastic Eye Procedures
0239--Level II Repair and Plastic Eye Procedures
0240--Level III Repair and Plastic Eye Procedures
0241--Level IV Repair and Plastic Eye Procedures
0242--Level V Repair and Plastic Eye Procedures
0243--Strabismus/Muscle Procedures
0244--Corneal and Amniotic Membrane Transplant
0246--Cataract Procedures with IOL Insert
0249--Cataract Procedures without IOL Insert
0252--Level III ENT Procedures
0253--Level IV ENT Procedures
0254--Level V ENT Procedures
0255--Level II Anterior Segment Eye Procedures
0256--Level VI ENT Procedures
0259--Level VII ENT Procedures
0293--Level VI Anterior Segment Eye Procedures
0319--Level III Endovascular Revascularization of the Lower Extremity
0384--GI Procedures with Stents
0387--Level II Hysteroscopy
0415--Level II Endoscopy Lower Airway
0419--Level II Upper GI Procedures
0422--Level III Upper GI Procedures
0423--Level II Percutaneous Abdominal and Biliary Procedures
0425--Level II Arthroplasty or Implantation with Prosthesis
0427--Level II Tube or Catheter Changes or Repositioning
0428--Level III Sigmoidoscopy and Anoscopy
0429--Level V Cystourethroscopy and other Genitourinary Procedures
0434--Cardiac Defect Repair
0648--Level IV Breast Surgery
0651--Complex Interstitial Radiation Source Application
0653--Vascular Reconstruction/Fistula Repair with Device
0654--Level II Insertion/Replacement of Permanent Pacemaker
0655--Insertion/Replacement/Conversion of a Permanent Dual Chamber 
Pacemaker or Pacing

[[Page 75116]]

0656--Transcatheter Placement of Intracoronary Drug-Eluting Stents
0672--Level III Posterior Segment Eye Procedures
0673--Level V Anterior Segment Eye Procedures
0674--Prostate Cryoablation
0687--Revision/Removal of Neurostimulator Electrodes
0688--Revision/Removal of Neurostimulator Pulse Generator Receiver

Appendix C

Discussion of the Outpatient Data

    This Appendix provides additional detail on how we identified 
outpatient claims for observation services or a major procedure 
spanning 2 midnights or more for purposes of estimating the shift in 
outpatient cases.
    The comprehensive APC analysis that also formed the basis for 
the 2 midnight analysis was performed using 2011 OPPS claims of bill 
type 13x extracted from the Standard Analytic File processed through 
December 31, 2011 with service line charges converted to costs per 
the usual OPPS cost modeling logic. (A description of the cost 
modeling logic can be found in the claims accounting document for 
each year of OPPS rulemaking and is available on our Web site at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html.) Similar conclusions regarding the -0.2 percent 
estimate can be drawn by analyzing the OPPS Limited Data Set rather 
than the Standard Analytic File. The CMS Web site at https://www.cms.gov/research-statistics-data-and-systems/files-for-order/limiteddatasets/HospitalOPPS.html provides information about 
ordering the OPPS Limited Data Set containing the outpatient 
hospital data. In order to facilitate a claims analysis using the 
claim from date and the claim through date a new field has been 
added to the OPPS Limited Data Set.
    Hospital OP claims do not readily distinguish between claims 
based on services provided while the beneficiary physically stayed 
at the hospital and claims where the beneficiary received recurring 
services on successive days while leaving the hospital between 
services. Since only continuous stays apply for this analysis, 
certain assumptions had to be made to indirectly estimate the body 
of claims for continuous stays. Claims were trimmed to only those 
whose full span of coverage (the difference of claim-through-date 
and claim-from-date) was less than 7 days. Claims with longer than a 
7 day span were excluded as unlikely to represent continuous 
overnight stays. Claims were then subset to those containing 
observation services or a significant procedure, as observation 
services are reported differently in those two subgroups. To further 
remove recurring services during this subsetting, claims that did 
not fall into one of the following were removed from the analysis:
     Claims containing G0378 (``Hospital observation per 
hr'') and a medical visit procedure code (status indicator of 
``V'');
     Claims containing G0379 (``Direct refer hospital 
observ''), considered to be ``medical claims;''
     Claims containing a significant OPPS procedure code 
(status indicator of ``S'' or ``T'') that received Medicare payment, 
considered to be ``surgical claims.''
    Next, the highest cost coded services on non-observation claims 
(those without G0379 or without G0378 and a medical visit procedure) 
were identified. Non-observation claims where the highest cost 
procedure was not a C-code (Temporary Hospital Outpatient PPS), a J-
code (non-orally administered medication and chemotherapy drugs), a 
significant OPPS procedure code (status indicator of ``S'' or 
``T''), or a medical visit procedure code (status indicator of 
``V'') were removed from the analysis. This removed non-observation 
claims where the highest cost service was not typical for a claim 
associated with a major procedure.
    Following these steps, a principal procedure representing the 
primary service driving the claim's overall utilization was 
identified for each remaining claim. For observation claims 
containing both G0379 and G0378 with a medical visit procedure, the 
principal procedure was identified as G0379 or G0378 depending on 
which code reports a higher line-item cost. Otherwise, observation 
claims were assigned a principal procedure of G0379 and G0378 
depending on whether G0379 or G0378 with a medical visit procedure 
were respectively reported.
    For non-observation claims, the principal procedure was 
identified as the claim's significant OPPS procedure code (status 
indicator of ``S'' or ``T'') with the highest line-item cost. Non-
observation claims where the earliest service date of the principal 
procedure occurred more than 5 days before or on the same date as 
the claim-through-date were removed from the analysis, as these were 
assumed to represent recurring services. Additionally, non-
observation claims were trimmed to those where the principal 
procedure occurs on only a single service date, thus removing any 
claim that contains major recurring services and ensuring that the 
stay is initiated with a single instance of the major procedure.
    To remove aberrant claims, each claim's non-observation total 
claim cost was then calculated by summing the line-item costs for 
all coded services and all OPPS packaged revenue centers on the 
claim. Each claim's span of coverage was also calculated as the 
number of days between the provision of the principal service and 
the claim's through-date. The geometric mean cost was calculated for 
each observation or non-observation principal procedure using the 
claims' total cost, and those claims with unreasonable costs (That 
is, claim costs above 100 times or below 1 percent of the principal 
procedure geometric mean cost) were trimmed from the analysis.
    For purposes of the 2 midnight analysis, we then further subset 
the data to APCs having a status indicator of ``T'' in order remove 
services which were not relevant for the 2 midnight analysis that 
is, to remove those services that were more likely to represent 
diagnostic services or minor procedures interjected into a series of 
recurring services, and were less likely to trigger a ``surgical'' 
episode in which a continuous stay followed the procedure. For 
similar reasons, our medical officers also removed some of the 
remaining APCs based on clinical judgment that those services were 
unlikely to be indicative of a continuous protracted hospital stay. 
The full list of OPPS status indicators and their definitions is 
published in the OPPS/ASC proposed and final rules each year, 
available on our Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html. The final list of major procedure APCs 
used in the development of the -0.2 percent estimate can be found in 
Appendix B.
    As described in section II.D of this notice, we have also been 
performing an analysis of the claims experience since the 
implementation of the 2-midnight policy. This analysis has used 
claims data from the OPPS Limited Data Set. We have also been 
examining similar data from our Integrated Data Repository (see 
https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/IDR/ for a description of the IDR). For the purpose 
of this analysis, we have used the following claim selection 
criteria: the third position of the provider number group was equal 
to ``0'' (short-term hospital) and the first 2 positions of the 
provider number were not equal to ``21'' (excludes Maryland 
hospitals.)
    We seek comment on the appropriate outpatient data source to use 
for the -0.2 percent estimate and any data trims and claims 
selection criteria that we should apply to the data.

Appendix D

Discussion of the Inpatient Data

    This Appendix provides additional detail on how we identified 
inpatient stays spanning less than 2 midnights for surgical MS-DRGs 
for purposes of estimating the shift in inpatient cases.
    The inpatient data used in the original -0.2 estimate was based 
on data from the CMS Integrated Data Repository (IDR) (see https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/IDR/ for a description of the IDR). The CMS Web site at 
http://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/ provides information about ordering the 
``MedPAR Limited Data Set (LDS)-Hospital (National)'' containing the 
publicly available inpatient hospital data. At the time the original 
-0.2 percent estimate was developed, we believed similar conclusions 
regarding the -0.2 percent estimate could be drawn using either the 
IDR or the publicly available inpatient data files. However, we did 
not verify this at the time.
    When we now compare the number of inpatient stays less than 2 
midnights for surgical MS-DRGs (excluding deaths and transfers) from 
the FY 2011 IDR data available to us at the time of the original -
0.2 estimate (claims processed through June of 2013) to the number 
from the FY 2011 MedPAR data (claims processed through March of 
2013), we get

[[Page 75117]]

approximately 360,000 stays from the IDR data and approximately 
380,000 stays from the MedPAR data. Further complicating a current 
analysis relative to the analysis performed at that time, when we 
examine the FY 2011 IDR data available to us now (claims processed 
through October 2015) compared to when the original -0.2 percent 
estimate was developed (claims processed through June 2013), we get 
approximately 340,000 stays instead of the originally estimated 
360,000 stays, which we suspect is at least partly driven by 
subsequent claim denials for these cases that have occurred since 
the data was examined for the original -0.2 percent estimate. 
Because the historical MedPAR data for a given fiscal year is not 
generally refreshed after it is created, unlike the IDR which is 
refreshed, there is no analogous number to the 340,000 for the FY 
2011 MedPAR.
    In determining the 380,000 number from the FY 2011 MedPAR, the 
following inpatient claim selection criteria and data trims were 
applied to the data. We selected FY 2011 MedPAR claims based on a FY 
2011 date of discharge where the National Claims History (NCH) claim 
type code was equal to ``60'' (inpatient hospital), the third 
position of the provider number group was equal to ``0'' (short-term 
hospital), the first 2 positions of the provider number were not 
equal to ``21'' (excludes Maryland hospitals), the destination 
discharge code was not equal to ``30'' (excludes still a patient), 
the special unit code was blank (excludes, for example, PPS exempt 
units), the GHO paid code was not equal to ``1'' (a group health 
organization has not paid the provider), the total charge amount was 
greater than 0, and the IME amount was not equal to the DRG price 
amount (indicating it was not a managed care claim).
    As described in section II.D of this notice, we have also been 
performing an analysis of the claims experience since the 
implementation of the 2-midnight policy. This analysis has used data 
from the publicly available MedPAR file and the IDR.
    We seek comment on the appropriate inpatient data source to use 
for the -0.2 percent estimate and any data trims and claims 
selection criteria that we should apply to the data.

[FR Doc. 2015-30486 Filed 11-30-15; 8:45 am]
BILLING CODE 4120-01-P



                                                                          Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices                                           75107

                                              ATSDR support for and collaboration                     Centers for Disease Control and                       Medicaid Services, Department of
                                              with tribes, and to improve the health                  Prevention, and the Agency for Toxic                  Health and Human Services, Attention:
                                              of tribes by pursuing goals that include                Substances and Disease Registry.                      CMS–1658–NC, P.O. Box 8013,
                                              assisting in eliminating the health                                                                           Baltimore, MD 21244–8013.
                                                                                                      Elaine L. Baker,
                                              disparities faced by Indian Tribes;                                                                              Please allow sufficient time for mailed
                                              ensuring that access to critical health                 Director, Management Analysis and Services            comments to be received before the
                                                                                                      Office, Centers for Disease Control and
                                              and human services and public health                                                                          close of the comment period.
                                                                                                      Prevention.
                                              services is maximized to advance or                                                                              3. By express or overnight mail. You
                                                                                                      [FR Doc. 2015–30357 Filed 11–30–15; 8:45 am]
                                              enhance the social, physical, and                                                                             may send written comments to the
                                                                                                      BILLING CODE 4163–18–P
                                              economic status of American Indian/                                                                           following address ONLY: Centers for
                                              Alaska Native (AI/AN) people; and                                                                             Medicare & Medicaid Services,
                                              promoting health equity for all AI/AN                                                                         Department of Health and Human
                                                                                                      DEPARTMENT OF HEALTH AND
                                              people and communities. To advance                                                                            Services, Attention: CMS–1658–NC,
                                              these goals, CDC/ATSDR conducts                         HUMAN SERVICES
                                                                                                                                                            Mail Stop C4–26–05, 7500 Security
                                              government-to-government                                Centers for Medicare & Medicaid                       Boulevard, Baltimore, MD 21244–1850.
                                              consultations with elected tribal                       Services                                                 4. By hand or courier. Alternatively,
                                              officials or their authorized                                                                                 you may deliver (by hand or courier)
                                              representatives. Consultation is an                     [CMS–1658–NC]                                         your written comments ONLY to the
                                              enhanced form of communication that                     RIN 0938–ZB23                                         following addresses:
                                              emphasizes trust, respect, and shared                                                                            a. For delivery in Washington, DC—
                                              responsibility. It is an open and free                  Medicare Program; Inpatient                           Centers for Medicare & Medicaid
                                              exchange of information and opinion                     Prospective Payment Systems; 0.2                      Services, Department of Health and
                                              among parties that leads to mutual                      Percent Reduction                                     Human Services, Room 445–G, Hubert
                                              understanding and comprehension.                                                                              H. Humphrey Building, 200
                                                 Matters for Discussion: The TAC and                  AGENCY: Centers for Medicare &
                                                                                                                                                            Independence Avenue SW.,
                                              CDC leaders’ discussions will include                   Medicaid Services (CMS), HHS.
                                                                                                                                                            Washington, DC 20201.
                                              the following public health topics:                     ACTION: Notice with comment period.                      (Because access to the interior of the
                                              Adverse childhood experiences, e-                       SUMMARY:    In accordance with the                    Hubert H. Humphrey Building is not
                                              cigarettes, motor vehicle-related injury                Court’s October 6, 2015 order in Shands               readily available to persons without
                                              prevention, and CDC’s budget.                           Jacksonville Medical Center, Inc., et al.             Federal government identification,
                                                 During the 14th Biannual Tribal                                                                            commenters are encouraged to leave
                                                                                                      v. Burwell, No. 14–263 (D.D.C.) and
                                              Consultation Session, tribes and CDC                                                                          their comments in the CMS drop slots
                                                                                                      consolidated cases that challenge the 0.2
                                              leaders will engage in a listening session                                                                    located in the main lobby of the
                                                                                                      percent reduction in inpatient
                                              with CDC’s director and roundtable                                                                            building. A stamp-in clock is available
                                                                                                      prospective payment systems (IPPS)
                                              discussions with CDC senior leaders.                                                                          for persons wishing to retain a proof of
                                                                                                      rates to account for the estimated $220
                                              Tribes will also have an opportunity to                                                                       filing by stamping in and retaining an
                                                                                                      million in additional FY 2014
                                              present testimony about tribal health                                                                         extra copy of the comments being filed.)
                                                                                                      expenditures resulting from the 2-
                                              issues.                                                                                                          b. For delivery in Baltimore, MD—
                                                 Tribal leaders are encouraged to                     midnight policy, this notice discusses
                                                                                                      the basis for the 0.2 percent reduction               Centers for Medicare & Medicaid
                                              submit written testimony by January 8,                                                                        Services, Department of Health and
                                              2016, to Alleen R. Weathers, Public                     and its underlying assumptions and
                                                                                                      invites comments on the same in order                 Human Services, 7500 Security
                                              Health Advisor for the Tribal Support                                                                         Boulevard, Baltimore, MD 21244–1850.
                                              Unit, OSTLTS, via mail to 4770 Buford                   to facilitate our further consideration of
                                                                                                      the FY 2014 reduction. We will consider                  If you intend to deliver your
                                              Highway NE., MS E–70, Atlanta,                                                                                comments to the Baltimore address, call
                                              Georgia, 30341–3717, or email                           and respond to the comments received
                                                                                                      in response to this notice, and to                    telephone number (410) 786–9994 in
                                              TribalSupport@cdc.gov.                                                                                        advance to schedule your arrival with
                                                 Based on the number of tribal leaders                comments already received on this issue
                                                                                                      in a final notice to be published by                  one of our staff members.
                                              giving testimony and the time available,                                                                         Comments erroneously mailed to the
                                              it may be necessary to limit the time for               March 18, 2016.
                                                                                                                                                            addresses indicated as appropriate for
                                              each presenter.                                         DATES: Comment date: To be assured
                                                                                                                                                            hand or courier delivery may be delayed
                                                 The agenda is subject to change as                   consideration, comments must be
                                                                                                                                                            and received after the comment period.
                                              priorities dictate.                                     received at one of the addresses
                                                                                                                                                               For information on viewing public
                                                 Information about the TAC, CDC/                      provided below, no later than 5 p.m.
                                                                                                                                                            comments, see the beginning of the
                                              ATSDR’s Tribal Consultation Policy,                     e.s.t. on February 2, 2016.
                                                                                                                                                            SUPPLEMENTARY INFORMATION section.
                                              and previous meetings can be found at                   ADDRESSES: In commenting, refer to file
                                              the following Web link: http://www.cdc.                                                                       FOR FURTHER INFORMATION CONTACT: Ing-
                                                                                                      code CMS–1658–NC. Because of staff
                                              gov/tribal.                                             and resource limitations, we cannot                   Jye Cheng, (410) 786–2260 or Don
                                                 Contact person for more information:                 accept comments by facsimile (FAX)                    Thompson, 410–786–6504.
                                              Alleen R. Weathers, Public Health                       transmission.                                         SUPPLEMENTARY INFORMATION: Inspection
                                              Advisor, CDC/OSTLTS, 4770 Buford                           You may submit comments in one of                  of Public Comments: All comments
                                              Highway NE., MS E–70, Atlanta,                          four ways (please choose only one of the              received before the close of the
                                              Georgia 30341–3717; email: alleen.                      ways listed):                                         comment period are available for
tkelley on DSK3SPTVN1PROD with NOTICES




                                              weathers@cdc.hhs.gov.                                      1. Electronically. You may submit                  viewing by the public, including any
                                                 The Director, Management Analysis                    electronic comments on this notice to                 personally identifiable or confidential
                                              and Services Office, has been delegated                 http://www.regulations.gov. Follow the                business information that is included in
                                              the authority to sign Federal Register                  ‘‘Submit a comment’’ instructions.                    a comment. We post all comments
                                              notices pertaining to announcements of                     2. By regular mail. You may mail                   received before the close of the
                                              meetings and other committee                            written comments to the following                     comment period on the following Web
                                              management activities, for both the                     address ONLY: Centers for Medicare &                  site as soon as possible after they have


                                         VerDate Sep<11>2014   23:35 Nov 30, 2015   Jkt 238001   PO 00000   Frm 00065   Fmt 4703   Sfmt 4703   E:\FR\FM\01DEN1.SGM   01DEN1


                                              75108                       Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices

                                              been received: http://                                  payment for each discharge so a net                   Direct admission of patient for hospital
                                              www.regulations.gov. Follow the search                  increase in the number of inpatient                   observation care. We used the difference
                                              instructions on that Web site to view                   encounters also results in increased                  between the first date of service for the
                                              public comments.                                        expenditures under the capital IPPS.)                 HCPCS code (generally the first date
                                                Comments received timely will also                                                                          that the service represented by that code
                                              be available for public inspection as                   II. Supplemental Notice Requesting                    was provided to the patient) and the
                                              they are received, generally beginning                  Comments on the FY 2014 IPPS Rule                     ‘‘claim through’’ date (generally the last
                                              approximately 3 weeks after publication                 A. Overview                                           date any service on the claim was
                                              of a document, at the headquarters of                                                                         provided to the patient) to determine
                                                                                                        As noted in section I. of this notice
                                              the Centers for Medicare & Medicaid                                                                           the length of the observation care. In
                                                                                                      with comment period, we estimated
                                              Services, 7500 Security Boulevard,                                                                            this manner, we identified
                                                                                                      based on an actuarial model that the 2-
                                              Baltimore, Maryland 21244, Monday                                                                             approximately 350,000 observation care
                                              through Friday of each week from 8:30                   midnight policy would increase IPPS
                                                                                                                                                            stays of 2 midnights or more using the
                                              a.m. to 4 p.m. e.s.t. To schedule an                    expenditures by approximately $220
                                                                                                                                                            CY 2011 claims.
                                              appointment to view public comments,                    million in FY 2014 due to an expected                    A list of the Ambulatory Payment
                                              phone 1–800–743–3951.                                   net increase in inpatient encounters, as              Classifications (APCs) containing the
                                                                                                      described in greater detail in an August              major procedures used in the
                                              I. Background                                           19, 2013 memorandum. (See Appendix                    determination of the ¥0.2 percent
                                                 In the final rule titled ‘‘Medicare                  A of this notice.)                                    estimate can be found in Appendix B of
                                              Program; Hospital Inpatient Prospective                   Section II.B. of this notice with                   this notice with comment period. As
                                              Payment Systems for the Acute Care                      comment period provides additional                    with observation care, the difference
                                              Hospitals and the Long-Term Care                        details on the calculation of this                    between the first date of service for the
                                              Hospital Prospective Payment System                     estimate (that is, what we did) and                   HCPCS code and the claim through date
                                              and Final Fiscal Year 2014 Rates;                       section II.C. of this notice with comment             was used to determine the length of the
                                              Quality Reporting Requirements for                      period discusses the actuaries’                       major procedure. We identified
                                              Specific Providers; Hospital Conditions                 assumptions, including why those                      approximately 50,000 claims containing
                                              of Participation; Payment Policies                      assumptions were reasonable. We                       major procedures with stays lasting 2
                                              Related to Patient Status’’ (hereinafter                collectively refer to the calculations and            midnights or more using the CY 2011
                                              referred to as the FY 2014 IPPS/LTCH                    assumptions as the actuarial ‘‘model’’                claims.
                                              PPS final rule), we adopted the 2-                      for estimating the financial impact of                   Combining the observation care and
                                              midnight policy effective October 1,                    the policy change. Section II.D. of this              the major procedures resulted in
                                              2013 (78 FR 50906 through 50954).                       notice with comment period discusses                  approximately 400,000 claims for
                                              Under the 2-midnight policy, an                         the status of an analysis currently being             services of 2 midnights or more from the
                                              inpatient admission is generally                        conducted by our actuaries of the claims              CY 2011 claims data.
                                              appropriate for Medicare Part A                         experience since the implementation of                   For additional details on the
                                              payment if the physician (or other                      the 2-midnight policy. We seek                        identification of the outpatient claims,
                                              qualified practitioner) admits the                      comment on all aspects of the model                   see Appendix C of this notice with
                                              patient as an inpatient based upon the                  used by our actuaries, including but not              comment period.
                                              expectation that the patient will need                  limited to those for which we                            In estimating the number of inpatient
                                              hospital care that crosses at least 2                   specifically request comment. We seek                 stays that would shift to the outpatient
                                              midnights. In assessing the expected                    comment on, and will consider                         setting, FY 2011 inpatient claims
                                              duration of necessary care, the                         comments on, all aspects of the 0.2                   containing a surgical Medicare Severity
                                              physician (or other practitioner) may                   percent reduction.                                    Diagnosis Related Group (MS–DRG)
                                              take into account outpatient hospital                                                                         were analyzed. The number of these
                                                                                                      B. Calculation of the Impact of the
                                              care received prior to inpatient                                                                              stays that spanned less than 2
                                                                                                      2-Midnight Policy
                                              admission. If the patient is expected to                                                                      midnights, based on the length of stay,
                                              need less than 2 midnights of care in the                  The task of modeling the impact of                 was approximately 360,000. FY 2009
                                              hospital, the services furnished should                 the 2-midnight policy on hospital                     and FY 2010 data were also analyzed
                                              generally be billed as outpatient                       payments begins with a recognition that               and the results were consistent with the
                                              services. Our actuaries estimated that                  some cases that were previously                       FY 2011 results.
                                              the 2-midnight policy would increase                    outpatient cases will become inpatient                   For additional details on the
                                              expenditures by approximately $220                      cases and vice versa. Therefore, our                  identification of the inpatient claims,
                                              million in FY 2014 due to an expected                   actuaries were required to develop a                  see Appendix D of this notice with
                                              net increase in inpatient encounters. We                model that determined the net effect of               comment period.
                                              used our authority under section                        the number of cases that would move in                   Our actuaries also assumed that
                                              1886(d)(5)(I)(i) of the Act to make a                   each direction.                                       payment under the OPPS would be 30
                                              reduction of 0.2 percent to the                            In estimating the number of                        percent of the payment under the IPPS
                                              standardized amount, the Puerto Rico                    outpatient cases that would shift to the              for encounters shifting between the two
                                              standardized amount, and the hospital-                  inpatient setting, we analyzed calendar               systems, and that the beneficiary is
                                              specific payment rate, and we used our                  year (CY) 2011 claims that included                   responsible for 20 percent of the Part B
                                              authority under section 1886(g) of the                  spending for observation care or a major              cost.
                                              Act to make a reduction of 0.2 percent                  procedure. For the purposes of the ¥0.2                  The number of short stay discharges
tkelley on DSK3SPTVN1PROD with NOTICES




                                              to the national capital Federal rate and                percent estimate, CMS physicians                      (for this purpose, same day discharges
                                              the Puerto Rico-specific capital rate, in               defined observation care as Outpatient                and discharges crossing one or two
                                              order to offset this estimated $220                     Prospective Payment System (OPPS)                     midnights) represented about 28 percent
                                              million in additional IPPS expenditures                 claims containing Healthcare Common                   of total discharges in FY 2011, and
                                              in FY 2014. (In addition to an operating                Procedure Coding System (HCPCS) code                  approximately 17 percent of total
                                              IPPS payment for each discharge,                        ‘‘G0378’’, Hospital observation service,              spending for the total discharges. The
                                              hospitals also receive a capital IPPS                   per hour, or HCPCS code ‘‘G0379’’                     assumed net increase of 40,000


                                         VerDate Sep<11>2014   23:35 Nov 30, 2015   Jkt 238001   PO 00000   Frm 00066   Fmt 4703   Sfmt 4703   E:\FR\FM\01DEN1.SGM   01DEN1


                                                                          Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices                                            75109

                                              inpatient discharges (= 400,000 OPPS to                 1. Estimated Outpatient Cases That                        If we had defined observation services
                                              IPPS—360,000 IPPS to OPPS)                              Would Shift to the Inpatient Setting                   using revenue center codes 0760 and
                                              represented an increase of 1.2 percent in                  As indicated previously, in estimating              0762 instead of HCPCS codes G0378
                                              the number of short stay discharges.                    the number of outpatient cases that                    and G0379, we would have identified
                                              Taking 1.2 percent of 17 percent of total               would shift to the inpatient setting, CY               approximately 400,000 claims for
                                              spending results in the estimate at the                 2011 claims that included spending for                 observation services spanning 2
                                              time of the FY 2014 IPPS/LTCH PPS                       observation care or a major procedure                  midnights or more (instead of 350,000)
                                              rulemaking that the 2-midnight policy                   were analyzed. This was done in order                  and we would have estimated
                                              would result in an additional $290                      to remove claims with diagnostic                       approximately 450,000 cases shifting
                                              million in inpatient expenditures, as                   services or minor procedures that would                from the outpatient to the inpatient
                                              shown for FY 2014 in the table ‘‘Impact                 be less likely to trigger an encounter in              setting (400,000 claims for observation
                                              on Medicare Expenditures’’ found in the                 which there was a continuous stay. (See                stays spanning more than 2 midnights
                                              memorandum in Appendix A of this                        the discussion in Appendix C of this                   and approximately 50,000 claims for
                                              notice. The estimates for the additional                notice with comment period.)                           major procedures) instead of the
                                              inpatient expenditures for FYs 2015                        For the purpose of the ¥0.2 percent                 400,000 cases used in the estimate. We
                                              through 2018 can also be found in the                   estimate, observation care was defined                 seek comment on whether it would be
                                              table (for example, $320 million for FY                 as OPPS claims containing HCPCS                        more appropriate to define observation
                                              2015).                                                  ‘‘G0378,’’ Hospital observation service,               services using revenue center codes
                                                 For the outpatient expenditure                       per hour, or ‘‘G0379’’ Direct admission                0760 and 0762 rather than HCPCS codes
                                              estimate, taking 30 percent (based on                   of patient for hospital observation care.              G0378 and G0379.
                                              the assumption that payment under the                   At the time the ¥0.2 percent estimate                     Another consequence of the use of the
                                              OPPS would be 30 percent of the                         was being developed, we were also                      claims analyses that we developed for
                                              payment under the IPPS) of 80 percent                   examining establishing comprehensive                   the purpose of the comprehensive APCs
                                              (to account for the assumed 20 percent                  APCs under the OPPS (for a summary of                  involves the approach used to
                                              beneficiary responsibility) of the $290                 the results of this examination see the                determine whether observation stays
                                              million inpatient estimate results in                   CY 2014 OPPS proposed rule (78 FR                      spanned 2 midnights or more. In
                                              approximately $70 million less                          43540)). One of the claims analyses that               general, in the claims analysis for
                                              outpatient expenditures. The estimates                  we developed for this purpose included                 comprehensive APC development, we
                                              for the reduction in outpatient                         service counts of G0378 and G0379 and                  examined the difference between the
                                              expenditures for FYs 2015 through 2018                  significant procedures. Since this                     date of service for the primary HCPCS
                                              can also be found in the table (For                     analysis included the universe of                      code on the claim and the claim through
                                              example, $80 million for FY 2015.)                      services of interest for the 2-midnight                date. For the observation services in this
                                                 The estimated $290 million increase                  policy at that time, it was well-suited for            analysis, we used the difference
                                              in inpatient expenditures less the                      use in the development of the ¥0.2                     between first date of service for the
                                              estimated $70 million decrease in                       percent estimate as well. For a                        observation service and the claim
                                              outpatient expenditures yields the                      discussion of the data specifications for              through date to determine the length of
                                              estimated net impact by our actuaries at                this claims analysis, and how it was                   the observation case. However, in
                                              the time of the FY 2014 IPPS/LTCH PPS                   subset for the 2-midnight analysis, see                retrospect, as with the definition of
                                              rulemaking of an additional $220                        Appendix C of this notice with                         observation services, this may have been
                                              million in expenditures in FY 2014 as                   comment period.                                        an overly conservative approach to
                                              a result of the 2-midnight policy. The                     However, in retrospect, using HCPCS                 determining the length of the
                                              estimated additional expenditures for                   G0378 and G0379 may have been an                       observation case. Under the 2-midnight
                                              FYs 2015 through 2018 can be similarly                  overly conservative definition of                      policy, for purposes of determining
                                              calculated.                                             observation services, because not every                whether the 2 midnight benchmark was
                                                 Using the information contained in                   use of observation services would be                   met and, therefore, whether inpatient
                                              this section and the appendices to this                 captured by the G-codes. As indicated                  admission was generally appropriate,
                                              notice, interested members of the public                in the Medicare Claims Processing                      the expected duration of care includes
                                              should be able to calculate the estimate                Manual,1 hospitals are required to                     the time the beneficiary spent receiving
                                              by our actuaries of an additional $220                  report observation charges under the                   outpatient services within the hospital.
                                              million in expenditures in FY 2014 as                   revenue center code ‘‘0760’’, Treatment                This includes services such as
                                              a result of the 2-midnight policy. (For                 or observation room—general                            observation services, treatments in the
                                              interested members of the public who                    classification, or ‘‘0762’’ Treatment or               emergency department, and procedures
                                              wish to perform this calculation, we                    observation room—observation room                      provided in the operating room or other
                                              highlight the discussion in Appendix D                  regardless of whether or not the G-codes               treatment area. It is not just the time
                                              regarding the number of inpatient cases                 are billed.                                            spent receiving observation services. As
                                              identified in the MedPAR data and the                      We also note that the Office of the                 such, it may have been more
                                              Integrated Data Repository.)                            Inspector General (OIG) used this                      appropriate to have used the ‘‘claim
                                                                                                      revenue center code definition of                      from’’ date (in general the date that the
                                              C. Discussion of the Assumptions Made                   observation services in its report                     beneficiary entered the hospital), rather
                                              in the Calculation of the Impact of the                 ‘‘Hospitals’ Use of Observation Stays                  than the first date that observation
                                              2-Midnight Policy                                       and Short Inpatient Stays 2 (OEI–02–12–                services were provided in order to
tkelley on DSK3SPTVN1PROD with NOTICES




                                                As our actuaries stated in the August                 00040).                                                determine when claims containing
                                              2013 memorandum, the estimates                                                                                 observation services spanned 2
                                              depend critically on the assumed                          1 See section 290.2.1 in Chapter 4 of the Medicare
                                                                                                                                                             midnights or more. If we had used such
                                              utilization changes in the inpatient and                Claims Processing Manual available at https://         an approach when developing the
                                                                                                      www.cms.gov/Regulations-and-Guidance/
                                              outpatient hospital settings. We discuss                Guidance/Manuals/downloads/clm104c04.pdf)              original estimate, instead of
                                              the assumptions underlying the                            2 Available at http://oig.hhs.gov/oei/reports/oei-   approximately 350,000 claims with
                                              estimates further in this section.                      02-12-00040.pdf.                                       observation services spanning 2


                                         VerDate Sep<11>2014   23:35 Nov 30, 2015   Jkt 238001   PO 00000   Frm 00067   Fmt 4703   Sfmt 4703   E:\FR\FM\01DEN1.SGM   01DEN1


                                              75110                       Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices

                                              midnights or more, the estimate would                   to behavioral changes by hospitals and                branched, with the initial portion of
                                              have been approximately 430,000                         admitting practitioners most inpatient                hospital care typically focused on
                                              claims under the HCPCS code G0378/                      medical encounters spanning less than                 diagnostics that serve to differentiate
                                              G0370 definition of observation services                2 midnights before the current 2-                     patient subsets that define treatments
                                              and approximately 520,000 under the                     midnight policy was implemented                       and simultaneously suggest different
                                              revenue center code 0760/0762                           might be reasonably expected to extend                hospital courses. The increased
                                              definition of observation services. When                past 2 midnights after its                            variability in the medical protocols is
                                              combined with our estimate of major                     implementation and would thus still be                influenced by the fact that, for planned
                                              procedures, we would have estimated as                  considered inpatient. They believed that              surgical admissions, more of the
                                              many as 570,000 cases shifting from the                 the clinical assessments and protocols                branching takes place in the process of
                                              outpatient to the inpatient setting under               used by physicians to develop an                      selecting a specific surgical intervention
                                              this approach instead of the 400,000                    expected length of stay for medical                   before the patient is admitted, while for
                                              cases used in the estimate. We seek                     cases were, in general, more variable                 medical admissions more of the
                                              comment on whether it would be more                     and less defined than those used to                   branching takes place after admission.
                                              appropriate to have used the claim from                 develop an expected length of stay for                  For these reasons, the clinical
                                              date rather than the first date that                    surgical cases.                                       judgment of CMS’s medical staff
                                              observation services were provided in                      Evidence of this medical/surgical                  supports our actuaries’ estimate of the
                                              order to determine when claims                          dichotomy is seen in proprietary                      impact of the 2-midnight policy on
                                              containing observation services spanned                 utilization review tools such as the                  program payments to hospitals.
                                              2 midnights or more.                                    Milliman Care Guidelines, which are
                                                                                                      guidelines based originally on actuarial              3. Estimated IPPS/OPPS Cost Difference
                                              2. Estimated Inpatient Cases That                       data, and InterQual, which are clinically             for Cases That Shift Between the IPPS
                                              Would Shift to the Outpatient Setting                   oriented guidelines. Both tools reflect               and OPPS
                                                 We believed some proportion of the                   the same types of distinctions between
                                              inpatient cases under 2 midnights in the                                                                        Our actuaries assumed that the OPPS
                                                                                                      medical and surgical cases that we
                                              historical data would remain inpatient                                                                        cost for services that shift between the
                                                                                                      assumed based on CMS medical staff’s
                                              because we believed that behavioral                                                                           OPPS and IPPS was 30 percent of the
                                                                                                      clinical judgment. Although all
                                              changes by hospitals and admitting                                                                            IPPS cost, and the beneficiary is
                                                                                                      guidelines, and all surgeons, advise
                                              practitioners would mitigate some of the                                                                      responsible for 20 percent of the OPPS
                                                                                                      patients that individual patients vary in
                                              impact of cases shifting between the                                                                          cost. The 30 percent is an assumption
                                                                                                      their post-operative courses, there are
                                              inpatient hospital setting and the                                                                            about the difference on average. While
                                                                                                      predictable post-operative courses that
                                              outpatient hospital setting. The question                                                                     payment under the OPPS is on average
                                                                                                      are based on such factors as whether or
                                              was how to reasonably estimate what                     not the abdominal cavity or the pleural               less than payment under the IPPS for
                                              that proportion would be for purposes                   cavity are entered, the expected time for             these cases, the key question is how
                                              of modelling the impact of the 2-                       recovery from anesthesia, the expected                much less on average? For any given
                                              midnight policy. We believe that a                      time to resume urinary function, the                  case, the payment differential will vary.
                                              model distinguishing between medical                    expected time to resume bowel                         We note that when the OIG examined
                                              and surgical cases is a reasonable                      function, the expected time to regain                 the payment differential between short
                                              approach to use in determining what                     mobility, and the typical period for                  inpatient stays and observation stays in
                                              proportion of inpatient cases would                     common post-operative interventions.                  their 2013 report ‘‘Hospitals’ Use of
                                              remain in the inpatient setting and what                These are by no means absolute but are                Observation Stays and Short Inpatient
                                              proportion would shift to the outpatient                fairly well-defined, as evidenced by the              Stays for Medicare Beneficiaries’’ (OEI–
                                              setting.                                                surgeon’s ability to generally inform the             02–12–00040), it found that on average
                                                 Specifically, in estimating the number               patient, within a day or so, how long the             Medicare paid nearly three times more
                                              of inpatient stays that would shift to the              patient probably can expect to remain in              for a short inpatient stay than an
                                              outpatient setting, FY 2011 inpatient                   the hospital if treatment goes well. Part             observation stay (p. 12). This is
                                              claims containing a surgical MS–DRG                     of this decreased variance is due to the              consistent with the 30 percent estimate
                                              were analyzed. Our actuaries assumed                    fact that the reason for admission, a                 used in the development of the ¥0.2
                                              that those spanning less than 2                         specific surgical procedure, is well-                 percent estimate. We seek comment on
                                              midnights (other than those stays that                  defined.                                              whether it is appropriate to utilize a 30
                                              were cut short by a death or transfer)                     Conversely, for medical admissions a               percent estimate.
                                              would shift from the inpatient setting to               single diagnosis typically covers a much              D. Claims Experience Since the
                                              the outpatient setting. Stays that were                 broader spectrum of possibilities.                    Implementation of the 2-Midnight Policy
                                              cut short by a death or transfer were                   Pneumonia may have different
                                              excluded because under the 2-midnight                   etiologies, with vastly different expected               Our actuaries are currently
                                              policy those cases would generally be                   lengths of stay. A stroke may be minor,               conducting an analysis of claims
                                              considered to be appropriately treated                  allowing a brief diagnostic workup to be              experience for FY 2014 and FY 2015 in
                                              on an inpatient basis. (For a discussion                followed by outpatient rehabilitation, or             light of available data, including the
                                              of the data specifications for the                      catastrophic, triggering a prolonged stay             MedPAR data. Because that analysis is
                                              inpatient claims analysis, see Appendix                 before stabilization and discharge.                   not yet complete, we are not proposing
                                              D of this notice.)                                      Chronic obstructive pulmonary disease                 in this notice with comment period to
                                                 Claims containing medical MS–DRGs                    (COPD) and congestive heart failure                   reconsider the 0.2 percent reduction in
tkelley on DSK3SPTVN1PROD with NOTICES




                                              were excluded because, as stated in the                 (CHF) may respond rapidly to                          the FY 2014 IPPS/LTCH PPS final rule
                                              August 2013 memorandum, ‘‘it was                        medication adjustments or may result in               based on the results of the claims
                                              assumed that these cases would be                       Intense Care Unit (ICU) stays. Unlike the             analysis. However, we are seeking
                                              unaffected by the policy change.’’ Our                  surgical procedure, the medical                       comment on whether we should await
                                              actuaries excluded medical MS–DRGs                      diagnosis does not imply a reasonably                 the completion of the actuaries’ analysis
                                              when developing the ¥0.2 percent                        consistent set of activities. In fact,                of FY 2014 and FY 2015 data before
                                              estimate because they believed that due                 typical medical protocols are highly                  resolution of this proceeding.


                                         VerDate Sep<11>2014   23:35 Nov 30, 2015   Jkt 238001   PO 00000   Frm 00068   Fmt 4703   Sfmt 4703   E:\FR\FM\01DEN1.SGM   01DEN1


                                                                          Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices                                            75111

                                                We note that any potential model                         There were also factors that could not             proceedings and publish a final notice
                                              revisions do not necessarily mean that                  be anticipated at the time of the initial             by March 18, 2016.
                                              the net result of the initial modelling,                modelling that may influence the actual                 We elected to promulgate the -0.2
                                              namely the ultimate ¥0.2 percent                        experience, such as the prohibition on                percent adjustment for the reasons
                                              adjustment, was incorrect. As we have                   Recovery Auditor post-payment reviews                 described in the FY 2014 IPPS/LTCH
                                              indicated since the ¥0.2 percent                        that became effective October 1, 2013.                PPS proposed and final rules and
                                              estimate was developed, the                             This prohibition might have affected                  elaborated upon in this notice with
                                              assumptions used for purposes of                        hospital behavior in unexpected ways.                 comment period. We request comment
                                              reasonably estimating overall impacts                                                                         on all aspects of that decision, including
                                                                                                         Our actuaries will continue to review
                                              cannot be construed as absolute                                                                               but not limited to the information,
                                                                                                      the claims experience for FY 2014 and                 assumptions, and analyses supporting
                                              statements about every individual                       subsequent years under the 2-midnight                 the adjustment.
                                              encounter. Under the original 2-                        policy to evaluate the assumptions
                                              midnight policy, our actuaries did not                  underlying the original estimate. As we               III. Collection of Information
                                              expect that every single surgical MS–                   indicated in the CY 2016 OPPS/ASC                     Requirements
                                              DRG encounter spanning less than 2                      final rule, we will take the reviews into               This document does not impose
                                              midnights would shift to the outpatient                 account during future rulemaking,                     information collection requirements,
                                              setting, that every single medical MS–                  including potential future rulemaking                 that is, reporting, recordkeeping or
                                              DRG encounter would remain in the                       on the issue of whether or not the policy             third-party disclosure requirements.
                                              inpatient setting, and that every single                change that we adopted for the medical                Consequently, there is no need for
                                              outpatient observation stay or major                    review of inpatient hospital admissions               review by the Office of Management and
                                              surgical encounter spanning more than                   under Medicare Part A described in the                Budget under the authority of the
                                              2 midnights would shift to the inpatient                CY 2016 OPPS final rule will have a                   Paperwork Reduction Act of 1995 (44
                                              setting. However, for purposes of                       differential impact on expenditures                   U.S.C. 3501 et seq.).
                                              developing the ¥0.2 percent adjustment                  compared to the original policy.                      IV. Response to Comments
                                              estimate under the original policy, a                   Although our analysis of the historical
                                              model where cases involving a surgical                  data since the implementation of the 2-                 Because of the large number of public
                                              MS–DRG spanning less than 2                             midnight policy is not yet complete, and              comments we normally receive on
                                              midnights in the historical data shifted                we do not propose to reconsider the                   Federal Register documents, we are not
                                              to the outpatient setting, cases involving              reduction in light of that analysis at this           able to acknowledge or respond to them
                                              a medical MS–DRG spanning less than                     time, we are including this discussion                individually. We will consider all
                                              2 midnights in the historical data                      in this notice because we received many               comments we receive by the date and
                                              remained in the inpatient setting, and                  comments on the CY 2016 OPPS                          time specified in the ‘‘DATES’’ section
                                              outpatient observation stays and major                  proposed rule asserting that the claims               of this preamble, and, when we proceed
                                              surgical encounters spanning more than                  data since the adoption of the original               with a subsequent document, we will
                                              2 midnights in the historical data                      2-midnight policy is inconsistent with                respond to the comments in the
                                              shifted to the inpatient setting yielded a              our original ¥0.2 percent estimate. We                preamble to that document.
                                              reasonable estimate of the net effect of                continue to invite comment on this                      Dated: November 20, 2015.
                                              the 2-midnight policy when it was                       issue. As indicated in the CY 2016                    Andrew M. Slavitt,
                                              adopted. To the extent the actual                       OPPS final rule, we intend to respond                 Acting Administrator, Centers for Medicare
                                              experience might vary for each of the                   to all public comments regarding the                  & Medicaid Services.
                                              individual assumptions, our actuaries                   validity of the original ¥0.2 percent                   Dated: November 24, 2015.
                                              estimated that the total net effect of that             adjustment that we received in response               Sylvia M. Burwell,
                                              variation would not significantly impact                to the CY 2016 OPPS proposed rule as                  Secretary, Department of Health and Human
                                              the estimate.                                           part of these Shands remand                           Services.
tkelley on DSK3SPTVN1PROD with NOTICES




                                         VerDate Sep<11>2014   23:35 Nov 30, 2015   Jkt 238001   PO 00000   Frm 00069   Fmt 4703   Sfmt 4703   E:\FR\FM\01DEN1.SGM   01DEN1


roue        Rederal Resister/Val 80, No. 230/ Tuesday, Decemaer 1, 2015/Notices
appentca




                                                            CATS,
           Offiroltic Acton
           BAE        Aeoinms
           somed Esimant Rrowiat         teisor 2 Mwist Poby
            Thys memenndin orvmatiesh Offc o ie Acayfnanciorimoc ies
           inpit us oupabiant hsptl trdeswhatllaiys uicapo2 mt wlb cmd
           tobe ncaten. Recentavoland o hiisw and eova itdissonon desrbed
           boow
           Bied olonsmendin CMS poliy it bovitwhmita chim PAe A inpudensenviss
           ad ht hn wae ied ts thsondcwa o stt have tid n an outatent
           aetin,tho h howitl oldrtebnowvrtsbmit in o PB robunment? A
           resontdecion by an AviitiaivLaw dgo (AL).utichs boreoninad y the
           Dopermetal Agpons ovetuchoias Pt wiling o oll sc dninPA hn hi
           h banapored nduptelt ty snA CNS uidmsn e nwofreiling o nmonaiend
           Wlow
                   +A Adnistatotlingallowed povies t venatentsreill P in uch
           cwes, uin anvn C2013 and codin n Septner of20. uihout intogo
           thouth h npols poces
                   + Bepulton chons wuldsericveie w unly hoiness whe tretited
           dtaimo Pat sevieswasmibnited wthn 12 mtof toigtdae afvensco Ths
           choase s unto ike itc heanrine in Oucber af 2012
                   + Reaudtorychanecladingtatifa bospot is spoaned2 idthonit vos
           preurd o be on peions This hing is munadioie ut beaiming n Ocoberof
           lons
            The ALdision is osinaad to merene Modicn expedit ies n prtbecuurofh caf ie
           aiiiecl PanB ramense ko dvet twchanges n howr                             ts
           erview, ow he uty f oG reinbacumenshuld hi PA sns b dnid, The
            Adritisrimeow temsemed t t increme expntito sc oo des acld w Pn
           B wiltet e noxtio agpeda PA drial, The 12 mantresticiosny ie opuaion
           nould       a th init h srcamsones in whicha ospia could yebil and hry mmantaly
           reduc tonb of ues nibie Pan A imlareab offering h hstercon ons


             con niian ooo oen t ue


   Eaderat Register/Vol. 60. No: 230/Tussday, December 1, 2015/Notices            us




theALJ deinon and he pevpred Adninseataring.Thwofe ntimput ofthe AL
decisan. Adninmntrlin nd e 2.mont fvls fln ecierseionedile
‘Be 2 ids dsn plic is entinand t io Medicreupetes dn o an
asnered ntinerane n ipatn Rplt winitions cnuting hoat in cas o ie
cutnaientstin, ies protidea asonly raured o ksn a bevaeiny er 2 nitini in ordr
for hssy w beconstret inatens To odet words is asumelt some css wouldswich
tm inpatnttocrpatent and on from ouprie n inpaien, ut h er tin an assumad
inerase in inatert spta adisions. Sn asumptens es madeestmat thfowncal
inss ofhi plin chingnand the y avupdons e desciba elow
        + Tss impaet hnsd ontasonptions on rszctons lom the Proidents FY
    13 Dds
        i Inoaimaing thenunbeofounateces i woud stt e npnionsoune.
dltmsts inludaapeninfr otrorntioncae o a maje on wereaited
Oupaieno t wereshorertha2 midnghs and hsn tha oreotforobsontonue
arfia majepeesdare uie excludedhoi it was mmed ht th caes soutd bo
unafitedb the poly chane Th nurbeofhsn atos ht spnned 2 r normids
boudontbessvicewaapnrcinatly 400000
        1 Insnimiting the ninbeofinpuiensivs ht utdt o h otplntsetin.
clamseontiig y M DRCGwer anayant. Chimecomniring medeal \G.ORO®
sad hotredtadin dn o a wanfar w cloded oct wa asunadtartese
«sieswouldb rafta y shpaleychsng. Th manbarotss tat soumod s
thn t mitighes based onh eofts es aprovimrcy 210 000
        +) Thestinas wesprmay besed on P¥ 201 dan: Moweven FY 2000 nPY
2010 dsevere in anlzndand the enty waeconitet onle IY 201 es
        + ThPrI oi frsveset should have beo pronced i th oupatonseving s
qed ibroudly esn oftPasa oouhn pouiin h opot maing, d
the beafican is rexpondblefo20 promofh PaB cot Comemsnth, whn n inpuion
adnision i danet, h et Pi subitnaly lovein ho PA co.
        + hi ie a umt dwnsofmeceniyuin y se snnaty wehae
deromined t tmnhodslos dn d osumptonsd easomtle forthe parposeof
stt h ovenl inpat ofhpreposed idhit t i mporant t rote e ho
nunpians oa fr prpess ofremonatly ninng tovonll nona shold otbe
ons aiolto ttements homry incidl ecnetec Yo vanple n vory
  intesinical MG.DRCaporin o hi 2 widnigts wl it i oapniot uindot o
sinle outpaiencbsuvaton uy o nsl suaienterconespaning mer than2ies
wilsit o npmven
        + Thnaber of shrany dachipes repsmisut 2 pavon ofol           dechorses
and aprecimaay 17 percet owl apenin hi shvedachaton The mwunedineicowo
of 10000 dichiss eonts i inerut t 2pret n he uie fsor say dacirges
        + Thes vouldHal b a is in thutlzniono NB uies inporin of
the cassthatshit hoouipatinns iputontcouldroltina           Bwadon te 2011
Mabca& MitcSupplonen cb13 peeen o 5010copaient se nutet n
a flnap SNI s wit oun enofste afabou27 ysd i imcotto
Mebcanaf pprounaily $1.000 aratis.Sicee stid nsc‘ conenty have


roua    Rederal Register/¥ol. 60, No 230/ Tussday, Decombee 1, 2015/Notices




       anscined 5N atehy are Mely o b o eivrbeveiate thrort wassumnd
       davonly10 pernencahid ce waud ut in allow iSNFaoy, n oddin,the
       aneraeent pc SWstu farthse esisasuned t e 0 parcenow hn tevonge,
       hidis e canbind feco aumid shre leaths of y and lvercssnmix
       Te hlds belowennties e inpact on Metice pnding sbPutA and P arent
       of e 2aidughtpiie Therechings e neily h eiltof h changsein ilzanon of
       ioowxtand oupatont hospra se            Horcach. Theanouts e townin nitlons
       To inyeus 200 troug 2008
                                  mannwantommima
                 L__—
                                                 Houea
                 Iosiieimava       mins
                   jos     in
                   Rd     w
                   ie      in

       A orton obis ditonl cot is t ifi aplinan iammentGinorothe
       sundartiend rtec explina n hfi e Medicre rogran; opratepuien:
       Propectis hment Situns fr uitCreHowptals n theLoog TernCarKal
       Promatirs Pasmant Synemand ol en 2904 azesChalty Raporing Reremaus for
       Spoife residrs Hoptl Conitons fPatiinnionPaymartPobies l o Pn
       Somes (CMS:  1991,CMS—IHRET3Theds wutlbe onl fr thas cmd io
       ospite careuhich rompseseta t h uie thorbythsumofe tenon e onpaiet
       eetumes Thiancunt is $220 milloin FY 201,nich totutosto n 2 orcntdicton in
       themodatiend novwis
       Pm or thfolonin cavets uin o ths entnnts. Theaculcoo on wing wil
       depesabsantally on pselchanaes n btfar y bapalsnd he BA antsh
         anges curothe sntopated wib ceminy. Whis t esinara on notpciyseniteto
       woryofhemurnpdonuind abov, hy h dipend eatclb on the sn lzation
       dsnz ithe inoatonanutpaien oupresings. Whte we blave hat se
       aesumptooresotbl, cetalysnalt efenge meuldhas uorporionaieit on ie
       estiandntcot. For thismaon, hests n iesa muchanaterdepe o
       Anestany thin uonlid ctn rentscould o sipnfconty hom ts stomes.Plecn
       lt i rowifsou c any mestons stout tisinfomation
             Suament Cotoms ASA                Jsn 0 Stow, sA
             owBivwesMetcorcant Metil Got Duwin utoolMatoid Conttoas
             Bm Gme                             Gun
            hia freaito, rea                   Cirent Neratont AsA
            Actan,Mebore m oldC                Bejoy Dreaon eb t Ned Con
            Ge                                 BimnGoo


                                                                          Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices                                        75115

                                              Appendix B                                              0088—Thrombectomy                                     0220—Level I Nerve Procedures
                                                                                                      0089—Insertion/Replacement of                         0221—Level II Nerve Procedures
                                              List of APCs Containing Major
                                                                                                        Permanent Pacemaker and Electrodes                  0224—Implantation of Catheter/
                                              Procedures For Purposes of the 2
                                                                                                      0090—Level I Insertion/Replacement of                   Reservoir/Shunt
                                              Midnight Estimate                                                                                             0227—Implantation of Drug Infusion
                                                                                                        Permanent Pacemaker
                                              APC—APC Description                                     0091—Level II Vascular Ligation                         Device
                                              0005—Level II Needle Biopsy/                            0092—Level I Vascular Ligation                        0229—Level II Endovascular
                                                Aspiration Except Bone Marrow                         0093—Vascular Reconstruction/Fistula                    Revascularization of the Lower
                                              0007—Level II Incision & Drainage                         Repair without Device                                 Extremity
                                              0008—Level III Incision and Drainage                    0103—Miscellaneous Vascular                           0233—Level III Anterior Segment Eye
                                              0012—Level I Debridement &                                Procedures                                            Procedures
                                                Destruction                                           0104—Transcatheter Placement of                       0234—Level IV Anterior Segment Eye
                                              0017—Level V Debridement &                                Intracoronary Stents                                  Procedures
                                                Destruction                                           0105—Repair/Revision/Removal of                       0237—Level II Posterior Segment Eye
                                              0019—Level I Excision/Biopsy                              Pacemakers, AICDs, or Vascular                        Procedures
                                              0020—Level II Excision/Biopsy                             Devices                                             0238—Level I Repair and Plastic Eye
                                              0021—Level III Excision/Biopsy                          0106—Insertion/Replacement of                           Procedures
                                              0022—Level IV Excision/Biopsy                                                                                 0239—Level II Repair and Plastic Eye
                                                                                                        Pacemaker Leads and/or Electrodes
                                              0028—Level I Breast Surgery                             0107—Insertion of Cardioverter-                         Procedures
                                              0029—Level II Breast Surgery                                                                                  0240—Level III Repair and Plastic Eye
                                                                                                        Defibrillator Pulse Generator
                                              0030—Level III Breast Surgery                                                                                   Procedures
                                                                                                      0108—Insertion/Replacement/Repair of                  0241—Level IV Repair and Plastic Eye
                                              0037—Level IV Needle Biopsy/
                                                                                                        Cardioverter-Defibrillator System                     Procedures
                                                Aspiration Except Bone Marrow
                                              0041— Arthroscopy                                       0113—Excision Lymphatic System                        0242—Level V Repair and Plastic Eye
                                              0042—Level II Arthroscopy                               0114—Thyroid/Lymphadenectomy                            Procedures
                                              0045—Bone/Joint Manipulation Under                        Procedures                                          0243—Strabismus/Muscle Procedures
                                                Anesthesia                                            0115—Cannula/Access Device                            0244—Corneal and Amniotic Membrane
                                              0047—Arthroplasty without Prosthesis                      Procedures                                            Transplant
                                              0048—Level I Arthroplasty or                            0121—Level I Tube or Catheter Changes                 0246—Cataract Procedures with IOL
                                                Implantation with Prosthesis                            or Repositioning                                      Insert
                                              0049—Level I Musculoskeletal                            0130—Level I Laparoscopy                              0249—Cataract Procedures without IOL
                                                Procedures Except Hand and Foot                       0131—Level II Laparoscopy                               Insert
                                              0050—Level II Musculoskeletal                           0132—Level III Laparoscopy                            0252—Level III ENT Procedures
                                                Procedures Except Hand and Foot                       0135—Level III Skin Repair                            0253—Level IV ENT Procedures
                                              0051—Level III Musculoskeletal                          0136—Level IV Skin Repair                             0254—Level V ENT Procedures
                                                Procedures Except Hand and Foot                       0137—Level V Skin Repair                              0255—Level II Anterior Segment Eye
                                              0052—Level IV Musculoskeletal                           0148—Level I Anal/Rectal Procedures                     Procedures
                                                Procedures Except Hand and Foot                       0149—Level III Anal/Rectal Procedures                 0256—Level VI ENT Procedures
                                              0053—Level I Hand Musculoskeletal                       0150—Level IV Anal/Rectal Procedures                  0259—Level VII ENT Procedures
                                                                                                      0152—Level I Percutaneous Abdominal                   0293—Level VI Anterior Segment Eye
                                                Procedures
                                              0054—Level II Hand Musculoskeletal                        and Biliary Procedures                                Procedures
                                                                                                      0153—Peritoneal and Abdominal                         0319—Level III Endovascular
                                                Procedures
                                              0055—Level I Foot Musculoskeletal                         Procedures                                            Revascularization of the Lower
                                                Procedures                                            0154—Hernia/Hydrocele Procedures                        Extremity
                                                                                                      0160—Level I Cystourethroscopy and                    0384—GI Procedures with Stents
                                              0056—Level II Foot Musculoskeletal
                                                                                                        other Genitourinary Procedures                      0387—Level II Hysteroscopy
                                                Procedures                                                                                                  0415—Level II Endoscopy Lower
                                              0057—Bunion Procedures                                  0161—Level II Cystourethroscopy and
                                                                                                        other Genitourinary Procedures                        Airway
                                              0062—Level I Treatment Fracture/                                                                              0419—Level II Upper GI Procedures
                                                Dislocation                                           0162—Level III Cystourethroscopy and
                                                                                                        other Genitourinary Procedures                      0422—Level III Upper GI Procedures
                                              0063—Level II Treatment Fracture/                                                                             0423—Level II Percutaneous Abdominal
                                                Dislocation                                           0163—Level IV Cystourethroscopy and
                                                                                                                                                              and Biliary Procedures
                                              0064—Level III Treatment Fracture/                        other Genitourinary Procedures                      0425—Level II Arthroplasty or
                                                Dislocation                                           0166—Level I Urethral Procedures
                                                                                                                                                              Implantation with Prosthesis
                                              0069—Thoracoscopy                                       0168—Level II Urethral Procedures                     0427—Level II Tube or Catheter
                                              0074—Level IV Endoscopy Upper                           0169—Lithotripsy                                        Changes or Repositioning
                                                Airway                                                0174—Level IV Laparoscopy                             0428—Level III Sigmoidoscopy and
                                              0075—Level V Endoscopy Upper                            0181—Level II Male Genital Procedures                   Anoscopy
                                                Airway                                                0183—Level I Male Genital Procedures                  0429—Level V Cystourethroscopy and
                                              0076—Level I Endoscopy Lower Airway                     0184—Prostate Biopsy                                    other Genitourinary Procedures
                                              0080—Diagnostic Cardiac                                 0190—Level I Hysteroscopy                             0434—Cardiac Defect Repair
                                                Catheterization                                       0192—Level IV Female Reproductive                     0648—Level IV Breast Surgery
                                              0082—Coronary or Non-Coronary                             Proc                                                0651—Complex Interstitial Radiation
                                                Atherectomy                                           0193—Level V Female Reproductive                        Source Application
tkelley on DSK3SPTVN1PROD with NOTICES




                                              0083—Coronary Angioplasty,                                Proc                                                0653—Vascular Reconstruction/Fistula
                                                Valvuloplasty, and Level I                            0195—Level VI Female Reproductive                       Repair with Device
                                                Endovascular Revascularization                          Procedures                                          0654—Level II Insertion/Replacement of
                                              0085—Level II Electrophysiologic                        0202—Level VII Female Reproductive                      Permanent Pacemaker
                                                Procedures                                              Procedures                                          0655—Insertion/Replacement/
                                              0086—Level III Electrophysiologic                       0208—Laminotomies and                                   Conversion of a Permanent Dual
                                                Procedures                                              Laminectomies                                         Chamber Pacemaker or Pacing


                                         VerDate Sep<11>2014   23:35 Nov 30, 2015   Jkt 238001   PO 00000   Frm 00073   Fmt 4703   Sfmt 4703   E:\FR\FM\01DEN1.SGM   01DEN1


                                              75116                       Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices

                                              0656—Transcatheter Placement of                            • Claims containing G0379 (‘‘Direct refer          recurring services, and were less likely to
                                                Intracoronary Drug-Eluting Stents                     hospital observ’’), considered to be ‘‘medical        trigger a ‘‘surgical’’ episode in which a
                                              0672—Level III Posterior Segment Eye                    claims;’’                                             continuous stay followed the procedure. For
                                                                                                         • Claims containing a significant OPPS             similar reasons, our medical officers also
                                                Procedures
                                                                                                      procedure code (status indicator of ‘‘S’’ or          removed some of the remaining APCs based
                                              0673—Level V Anterior Segment Eye                       ‘‘T’’) that received Medicare payment,                on clinical judgment that those services were
                                                Procedures                                            considered to be ‘‘surgical claims.’’                 unlikely to be indicative of a continuous
                                              0674—Prostate Cryoablation                                 Next, the highest cost coded services on           protracted hospital stay. The full list of OPPS
                                              0687—Revision/Removal of                                non-observation claims (those without G0379           status indicators and their definitions is
                                                Neurostimulator Electrodes                            or without G0378 and a medical visit                  published in the OPPS/ASC proposed and
                                              0688—Revision/Removal of                                procedure) were identified. Non-observation           final rules each year, available on our Web
                                                Neurostimulator Pulse Generator                       claims where the highest cost procedure was           site at https://www.cms.gov/Medicare/
                                                Receiver                                              not a C-code (Temporary Hospital Outpatient           Medicare-Fee-for-Service-Payment/
                                                                                                      PPS), a J-code (non-orally administered               HospitalOutpatientPPS/Hospital-Outpatient-
                                              Appendix C                                              medication and chemotherapy drugs), a                 Regulations-and-Notices.html. The final list
                                                                                                      significant OPPS procedure code (status               of major procedure APCs used in the
                                              Discussion of the Outpatient Data                       indicator of ‘‘S’’ or ‘‘T’’), or a medical visit      development of the ¥0.2 percent estimate
                                                This Appendix provides additional detail              procedure code (status indicator of ‘‘V’’) were       can be found in Appendix B.
                                              on how we identified outpatient claims for              removed from the analysis. This removed                  As described in section II.D of this notice,
                                              observation services or a major procedure               non-observation claims where the highest              we have also been performing an analysis of
                                              spanning 2 midnights or more for purposes               cost service was not typical for a claim              the claims experience since the
                                              of estimating the shift in outpatient cases.            associated with a major procedure.                    implementation of the 2-midnight policy.
                                                The comprehensive APC analysis that also                 Following these steps, a principal                 This analysis has used claims data from the
                                              formed the basis for the 2 midnight analysis            procedure representing the primary service            OPPS Limited Data Set. We have also been
                                              was performed using 2011 OPPS claims of                 driving the claim’s overall utilization was           examining similar data from our Integrated
                                              bill type 13x extracted from the Standard               identified for each remaining claim. For              Data Repository (see https://www.cms.gov/
                                              Analytic File processed through December                observation claims containing both G0379              Research-Statistics-Data-and-Systems/
                                              31, 2011 with service line charges converted            and G0378 with a medical visit procedure,             Computer-Data-and-Systems/IDR/ for a
                                              to costs per the usual OPPS cost modeling               the principal procedure was identified as             description of the IDR). For the purpose of
                                              logic. (A description of the cost modeling              G0379 or G0378 depending on which code                this analysis, we have used the following
                                              logic can be found in the claims accounting             reports a higher line-item cost. Otherwise,           claim selection criteria: the third position of
                                              document for each year of OPPS rulemaking               observation claims were assigned a principal          the provider number group was equal to ‘‘0’’
                                              and is available on our Web site at https://            procedure of G0379 and G0378 depending on             (short-term hospital) and the first 2 positions
                                              www.cms.gov/Medicare/Medicare-Fee-for-                  whether G0379 or G0378 with a medical visit           of the provider number were not equal to
                                              Service-Payment/HospitalOutpatientPPS/                  procedure were respectively reported.                 ‘‘21’’ (excludes Maryland hospitals.)
                                              Hospital-Outpatient-Regulations-and-                       For non-observation claims, the principal             We seek comment on the appropriate
                                              Notices.html.) Similar conclusions regarding            procedure was identified as the claim’s               outpatient data source to use for the ¥0.2
                                              the ¥0.2 percent estimate can be drawn by               significant OPPS procedure code (status               percent estimate and any data trims and
                                              analyzing the OPPS Limited Data Set rather              indicator of ‘‘S’’ or ‘‘T’’) with the highest         claims selection criteria that we should apply
                                              than the Standard Analytic File. The CMS                line-item cost. Non-observation claims where          to the data.
                                              Web site at https://www.cms.gov/research-               the earliest service date of the principal
                                                                                                                                                            Appendix D
                                              statistics-data-and-systems/files-for-order/            procedure occurred more than 5 days before
                                              limiteddatasets/HospitalOPPS.html provides              or on the same date as the claim-through-date         Discussion of the Inpatient Data
                                              information about ordering the OPPS Limited             were removed from the analysis, as these                 This Appendix provides additional detail
                                              Data Set containing the outpatient hospital             were assumed to represent recurring services.         on how we identified inpatient stays
                                              data. In order to facilitate a claims analysis          Additionally, non-observation claims were             spanning less than 2 midnights for surgical
                                              using the claim from date and the claim                 trimmed to those where the principal                  MS–DRGs for purposes of estimating the shift
                                              through date a new field has been added to              procedure occurs on only a single service             in inpatient cases.
                                              the OPPS Limited Data Set.                              date, thus removing any claim that contains              The inpatient data used in the original
                                                Hospital OP claims do not readily                     major recurring services and ensuring that            ¥0.2 estimate was based on data from the
                                              distinguish between claims based on services            the stay is initiated with a single instance of       CMS Integrated Data Repository (IDR) (see
                                              provided while the beneficiary physically               the major procedure.                                  https://www.cms.gov/Research-Statistics-
                                              stayed at the hospital and claims where the                To remove aberrant claims, each claim’s            Data-and-Systems/Computer-Data-and-
                                              beneficiary received recurring services on              non-observation total claim cost was then             Systems/IDR/ for a description of the IDR).
                                              successive days while leaving the hospital              calculated by summing the line-item costs for         The CMS Web site at http://www.cms.gov/
                                              between services. Since only continuous                 all coded services and all OPPS packaged              Research-Statistics-Data-and-Systems/Files-
                                              stays apply for this analysis, certain                  revenue centers on the claim. Each claim’s            for-Order/LimitedDataSets/ provides
                                              assumptions had to be made to indirectly                span of coverage was also calculated as the           information about ordering the ‘‘MedPAR
                                              estimate the body of claims for continuous              number of days between the provision of the           Limited Data Set (LDS)-Hospital (National)’’
                                              stays. Claims were trimmed to only those                principal service and the claim’s through-            containing the publicly available inpatient
                                              whose full span of coverage (the difference of          date. The geometric mean cost was calculated          hospital data. At the time the original ¥0.2
                                              claim-through-date and claim-from-date) was             for each observation or non-observation               percent estimate was developed, we believed
                                              less than 7 days. Claims with longer than a             principal procedure using the claims’ total           similar conclusions regarding the ¥0.2
                                              7 day span were excluded as unlikely to                 cost, and those claims with unreasonable              percent estimate could be drawn using either
                                              represent continuous overnight stays. Claims            costs (That is, claim costs above 100 times or        the IDR or the publicly available inpatient
                                              were then subset to those containing                    below 1 percent of the principal procedure            data files. However, we did not verify this at
                                              observation services or a significant                   geometric mean cost) were trimmed from the            the time.
                                              procedure, as observation services are                  analysis.                                                When we now compare the number of
                                              reported differently in those two subgroups.               For purposes of the 2 midnight analysis,           inpatient stays less than 2 midnights for
tkelley on DSK3SPTVN1PROD with NOTICES




                                              To further remove recurring services during             we then further subset the data to APCs               surgical MS–DRGs (excluding deaths and
                                              this subsetting, claims that did not fall into          having a status indicator of ‘‘T’’ in order           transfers) from the FY 2011 IDR data
                                              one of the following were removed from the              remove services which were not relevant for           available to us at the time of the original
                                              analysis:                                               the 2 midnight analysis that is, to remove            ¥0.2 estimate (claims processed through
                                                • Claims containing G0378 (‘‘Hospital                 those services that were more likely to               June of 2013) to the number from the FY
                                              observation per hr’’) and a medical visit               represent diagnostic services or minor                2011 MedPAR data (claims processed
                                              procedure code (status indicator of ‘‘V’’);             procedures interjected into a series of               through March of 2013), we get



                                         VerDate Sep<11>2014   23:35 Nov 30, 2015   Jkt 238001   PO 00000   Frm 00074   Fmt 4703   Sfmt 4703   E:\FR\FM\01DEN1.SGM   01DEN1


                                                                          Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices                                           75117

                                              approximately 360,000 stays from the IDR                   OMB No.: New Collection.                           the program components offered met
                                              data and approximately 380,000 stays from                  Description: The Administration for                their needs.
                                              the MedPAR data. Further complicating a                 Children and Families (ACF), Office of
                                              current analysis relative to the analysis                                                                        Data collection instruments for the B3
                                                                                                      Planning, Research and Evaluation
                                              performed at that time, when we examine the                                                                   study include the following: (1)
                                              FY 2011 IDR data available to us now (claims            (OPRE) proposes to collect information
                                                                                                                                                            Screening for program eligibility to help
                                              processed through October 2015) compared                as part of the Building Bridges and
                                                                                                                                                            ensure that only eligible fathers enroll
                                              to when the original ¥0.2 percent estimate              Bonds (B3) study. B3 will inform
                                              was developed (claims processed through                 policymakers, program operators, and                  in the study.
                                              June 2013), we get approximately 340,000                stakeholders about effective ways for                    (2) nFORM management information
                                              stays instead of the originally estimated               fatherhood programs to support fathers                system (MIS) to record study and
                                              360,000 stays, which we suspect is at least             in their parenting and employment. In                 participation information. Note: Only
                                              partly driven by subsequent claim denials for
                                              these cases that have occurred since the data
                                                                                                      particular, partnering with programs                  B3-specific burden is included with this
                                              was examined for the original ¥0.2 percent              that serve low-income fathers to                      request. All Responsible Fatherhood
                                              estimate. Because the historical MedPAR                 promote responsible fatherhood, the B3                Grantees (funded by the ACF Office of
                                              data for a given fiscal year is not generally           study will examine the effectiveness of               Family Assistance) are required to use
                                              refreshed after it is created, unlike the IDR           strategies used to (1) engage fathers in              nFORM. nFORM is being developed by
                                              which is refreshed, there is no analogous               program activities, (2) develop and                   the Fatherhood and Marriage Local
                                              number to the 340,000 for the FY 2011                   support parenting and co-parenting
                                              MedPAR.                                                                                                       Evaluation and Cross-site (FaMLE Cross-
                                                                                                      skills, and (3) advance the employment                site) Project and burden for these sites
                                                 In determining the 380,000 number from
                                              the FY 2011 MedPAR, the following                       of disadvantaged fathers. B3 will test                are captured under OMB #0970–0460.
                                              inpatient claim selection criteria and data             innovative, evidence-informed                         (3) Applicant characteristics and
                                              trims were applied to the data. We selected             approaches that will be added to the                  program operations data for one non-
                                              FY 2011 MedPAR claims based on a FY 2011                core components of fatherhood
                                              date of discharge where the National Claims                                                                   grantee site. We expect most of the B3
                                                                                                      programs and will reflect the most
                                              History (NCH) claim type code was equal to                                                                    sites will be federally funded
                                                                                                      recent developments in behavioral
                                              ‘‘60’’ (inpatient hospital), the third position         science, adult skill-building, child                  Responsible Fatherhood grantees, but it
                                              of the provider number group was equal to                                                                     is possible that one site will not and
                                              ‘‘0’’ (short-term hospital), the first 2 positions      development, and other relevant
                                                                                                      disciplines. The study will include up                therefore, this request includes burden
                                              of the provider number were not equal to
                                                                                                      to six sites and specific interventions               for one site to use nFORM. (4) Baseline
                                              ‘‘21’’ (excludes Maryland hospitals), the
                                              destination discharge code was not equal to             will vary by site.                                    and follow-up surveys for the impact
                                              ‘‘30’’ (excludes still a patient), the special             B3 includes an impact evaluation and               study. There will be two versions of
                                              unit code was blank (excludes, for example,             a process study. The impact evaluation                each survey, specific to the intervention
                                              PPS exempt units), the GHO paid code was                will involve randomly assigning                       tested. (5) Baseline and follow-up
                                              not equal to ‘‘1’’ (a group health organization                                                               questionnaires, interviews, focus
                                                                                                      individuals to a treatment or
                                              has not paid the provider), the total charge
                                              amount was greater than 0, and the IME                  comparison condition and comparing                    groups, and surveys to inform the
                                              amount was not equal to the DRG price                   key outcomes. In addition, the study                  process study; these will also be specific
                                              amount (indicating it was not a managed care            will collect information on employment,               to the intervention tested.
                                              claim).                                                 criminal justice and child support                       The sites that are part of the B3 study
                                                 As described in section II.D of this notice,         outcomes from administrative records.
                                              we have also been performing an analysis of                                                                   will use a slightly modified version of
                                                                                                      These data will be used to estimate the
                                              the claims experience since the                                                                               nFORM that includes B–3 specific
                                                                                                      effects of the parenting or employment
                                              implementation of the 2-midnight policy.                                                                      information, such as: (1) B3-specific
                                              This analysis has used data from the publicly           intervention on a range of outcomes
                                                                                                                                                            enrollment data (2) B3-specific
                                              available MedPAR file and the IDR.                      including employment; earnings; child
                                                                                                      support; father/child contact, shared                 information about focal child and co-
                                                 We seek comment on the appropriate
                                              inpatient data source to use for the ¥0.2               activities, and relationship quality;                 parent in in sites testing a parenting
                                              percent estimate and any data trims and                 father’s commitment to his child,                     intervention, and (3) B3 tracking of
                                              claims selection criteria that we should apply          parenting skills, and parenting efficacy;             child and co-parent attendance in
                                              to the data.                                            co-parenting relationship quality; and                services with the father for program
                                              [FR Doc. 2015–30486 Filed 11–30–15; 8:45 am]            criminal justice outcomes.                            group members in sites testing a
                                              BILLING CODE 4120–01–P                                     The process study will describe and                parenting intervention.
                                                                                                      document each newly established                          RESPONDENTS: Fathers seeking
                                                                                                      intervention and how it operated to                   services from one of the six Responsible
                                              DEPARTMENT OF HEALTH AND                                provide insight into the treatment                    Fatherhood Programs in the B3 study
                                              HUMAN SERVICES                                          differentials and the context for                     and staff members working at the B3
                                                                                                      interpreting findings of the impact                   sites.
                                              Administration for Children and                         study. The process study will also
                                              Families                                                highlight lessons to the field including
                                                                                                      what it takes to engage participants, the
                                              Proposed Information Collection
                                                                                                      challenges sites face when
                                              Activity; Comment Request
                                                                                                      implementing the parenting or
                                                Title: Building Bridges and Bonds                     employment intervention, and the
                                              (B3) Study: Data Collection.                            participants’ perspectives on whether
tkelley on DSK3SPTVN1PROD with NOTICES




                                         VerDate Sep<11>2014   23:35 Nov 30, 2015   Jkt 238001   PO 00000   Frm 00075   Fmt 4703   Sfmt 4703   E:\FR\FM\01DEN1.SGM   01DEN1



Document Created: 2018-03-02 09:10:51
Document Modified: 2018-03-02 09:10:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesComment date: To be assured consideration, comments must be
ContactIng-Jye Cheng, (410) 786-2260 or Don Thompson, 410-786-6504.
FR Citation80 FR 75107 
RIN Number0938-ZB23

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR