Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations 60315 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 21, 2012. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.628 is amended as 

follows: 

■ i. Remove the entries for crambe, seed; 

grain, aspirated fractions; hare’s ear 

mustard, seed; jojoba, seed; lesquerella, 

seed; milkweed, seed; mustard, seed; 

oil, radish, seed; poppy, seed; rapeseed, 

seed; rose hip, seed; sesame, seed; 

tallowwood, seed; tea oil plant, seed; 

vegetable, foliage of legume, except 

soybean, subgroup 7A, forage; vegetable, 

foliage of legume, except soybean, 

subgroup 7A, hay; and vegetable, 

legume, group 6, except soybeans; from 

the table in paragraph (a). 

■ ii. Revise the tolerances for cattle, fat; 

cattle, meat; goat, fat; goat, meat; horse, 

fat; horse, meat; sheep, fat; sheep, meat; 

in the table in paragraph (a). 

■ iii. Add alphabetically entries for 

cottonseed subgroup 20C, grain, 

aspirated grain fractions; rapeseed 

subgroup 20A; sunflower subgroup 20B; 

vegetable, legume, group 6; vegetable, 

foliage of legume, group 7, forage; and 

vegetable, foliage of legume, group 7, 

hay; to the table in paragraph (a). 

■ iv. Remove the entries for soybean, 

forage, and soybean, hay, from the table 

in paragraph (d). 

The added and revised text read as 

follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

Commodity Parts per 

million 

* * * * * 

Cattle, fat .................................. 0.5 

Cattle, meat .............................. 0.1 

* * * * * 

Cottonseed subgroup 20C ....... 0.3 

* * * * * 

Goat, fat .................................... 0.5 

Goat, meat ................................ 0.1 

* * * * * 

Grain, aspirated grain fractions 640 

* * * * * 

Horse, fat .................................. 0.5 

Horse, meat .............................. 0.1 

* * * * * 

Rapeseed subgroup 20B .......... 2.0 

* * * * * 

Sheep, fat ................................. 0.5 

Sheep, meat ............................. 0.1 

* * * * * 

Sunflower subgroup 20C .......... 0.3 

* * * * * 

Vegetable, legume, group 6 ..... 2.0 

Vegetable, foliage of legume, 

group 7, forage ..................... 30 

Vegetable, foliage of legume, 

group 7, hay .......................... 90 

* * * * * 

* * * * * 

[FR Doc. 2012–24152 Filed 10–2–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 412, 413, 424, and 476 

[CMS–1588–CN2] 

RIN 0938–AR12 

Medicare Program; Hospital Inpatient 

Prospective Payment Systems for 

Acute Care Hospitals and the LongTerm Care Hospital Prospective 

Payment System and Fiscal Year 2013 

Rates; Hospitals’ Resident Caps for 

Graduate Medical Education Payment 

Purposes; Quality Reporting 

Requirements for Specific Providers 

and for Ambulatory Surgical Centers; 

Corrections 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule; correction. 

SUMMARY: This document corrects 

technical errors in the final rule that 

appeared in the August 31, 2012 

Federal Register entitled ‘‘Medicare 

Program; Hospital Inpatient Prospective 

Payment Systems for Acute Care 

Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

and Fiscal Year 2013 Rates; Hospitals’ 

Resident Caps for Graduate Medical 

Education Payment Purposes; Quality 

Reporting Requirements for Specific 

Providers and for Ambulatory Surgical 

Centers.’’ 

DATES: Effective Date: October 1, 2012. 

FOR FURTHER INFORMATION CONTACT: Tzvi 

Hefter, (410) 786–4487. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2012–19079 of August 31, 

2012 (77 FR 53258), there were a 

number of technical errors that are 

identified and corrected in the 

Correction of Errors section of this 

correcting document. The provisions in 

this correcting document are effective as 

if they had been included in the final 

rule appearing in the August 31, 2012 

Federal Register. Accordingly, the 

corrections are effective October 1, 

2012. 

II. Summary of Errors and Corrections 

Posted on the CMS Web Site 

A. Errors in the Preamble 

On page 53268, in our summary of the 

provisions of the Hospital Inpatient 

Quality Reporting (IQR) Program, we 

inadvertently referenced hospitalacquired condition (HAC) measure sets 


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instead of healthcare-associated 

infection (HAI) measures sets. Also on 

this page, in our discussion of the cost 

and benefits of the Hospital 

Readmission Reduction Program, we 

made a technical error in the dollar 

amount by which the Hospital 

Readmission Reduction Program will 

reduce payments to hospitals. 

On page 53278, we made an 

inadvertent typographical error in the 

discussion of prospective adjustments 

for FY 2010 documentation and coding 

effect. 

On page 53315, in our discussion of 

International Classification of Disease, 

Ninth Revisions, Clinical Modification 

(ICD–9–CM), we inadvertently reference 

ICD–9–CM coding system instead of 

ICD–9–CM diagnosis codes. 

On pages 53386 and 53392, we made 

typographical errors in our summation 

of a public comment regarding the 

Hospital Readmission Reduction 

Program. 

On page 53387, we are correcting the 

Web site for obtaining the MedPAR files 

referenced in our discussion of 

aggregate payments for excess 

readmissions and aggregate payments 

for all discharges under the Hospital 

Readmission Reduction Program. 

On page 53485, in our discussion of 

long-term care hospital (LTCH) 

moratorium on the 25-percent payment 

adjustment threshold policy, we made 

typographical errors in an example. 

On page 53508, we made a 

grammatical error in our discussion of 

the Agency for Healthcare Research and 

Quality (AHRQ) indicators. 

On page 53545, in our discussion of 

validation approaches for the Hospital 

IQR Program, we made a typographical 

error. 

On page 53557, in our discussion of 

CDC/NHSN-based HAI measures for the 

PPS-Exempt Cancer Hospital Quality 

Reporting Program (PCHQR), we made a 

grammatical error. 

On page 53601, in the table regarding 

the final performance standards for the 

FY 2015 Hospital Value-Base 

Purchasing (HVBP) Program, we 

inadvertently omitted a clinical process 

of care measure. 

On page 53648, in our discussion of 

hospital-based inpatient psychiatric 

service (HBIPS) under the IPFQR 

Program, we made a typographical error. 

On page 53655, in our discussion of 

the reporting and submission 

requirements for 2014 IPFQR payment 

determinations, we inadvertently made 

technical and typographical errors in a 

response to a public comment. 

On page 53668, in our discussion of 

the information collection requirements 

for the LTCH Quality Reporting 

Program, we made two technical errors 

in describing the number of hospitals 

that report data to the National Health 

Safety Network (NHSN). 

On page 53669, in our discussion of 

the information collection requirements 

for the LTCH Quality Reporting 

Program, we made a grammatical error 

in our response to a comment regarding 

the cost associated with reported 

pressure ulcer data. 

B. Errors in the Addendum 

On page 53706, in the table titled 

‘‘Comparison of Factors and 

Adjustments: FY 2012 Capital Federal 

Rate and FY 2013 Capital Federal Rate,’’ 

there was a typographical error in the 

GAF/DRG Adjustment Factor shown for 

FY 2012. 

On page 53731, we made a technical 

error in the number and hospitals that 

we estimate will have their base 

operating payments reduced by 

readmission reduction program. 

C. Summary of Errors in and 

Corrections to Tables Posted on the CMS 

Web site 

On pages 53717, we list the tables that 

are tables available only through the 

Internet. We are correcting the following 

errors in Tables 9A, 9C, and 15: 

In Table 9A.—Hospital 

Reclassifications and Redesignations— 

FY 2013, Provider 010164 was 

inadvertently omitted. 

In Table 9C.—Hospitals Redesignated 

as Rural under Section 1886(d)(8)(E) of 

the Act—FY 2013, Provider 040118 was 

mistakenly listed as a section 401 

provider and will be removed. Provider 

290009 was inadvertently omitted and 

will be listed as a rural reclassification 

from CBSA 39900 to CBSA 29. 

In addition, we note that the 

correction of errors for Tables 9A and 

9C require us to make conforming 

changes to Tables 2, 4A, 4B, 4C, and 4J, 

respectively. 

In Table 15.—FY 2013 Final 

Readmissions Adjustment Factors, we 

inadvertently included Medicare 

inpatient claims from the FY 2008 

MedPAR file with discharge dates 

occurring prior to July 1, 2008 in 

determining the base operating DRG 

payment amounts in the calculation of 

aggregate payments for excess 

readmissions and aggregate payments 

for all discharges that were used to 

calculate the readmissions adjustment 

factors published for the FY 2013 IPPS/ 

LTCH final rule. Under the policy we 

adopted in that final rule, for FY 2013, 

aggregate payments for excess 

readmissions and aggregate payments 

for all discharges are calculated using 

data from Medicare inpatient MedPAR 

claims with discharge dates occurring 

on or after July 1, 2008, and no later 

than June 30, 2011. 

III. Waiver of Proposed Rulemaking 

and Delay in the Effective Date 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register to provide a period for public 

comment before the provisions of a rule 

take effect in accordance with section 

553(b) of the Administrative Procedure 

Act (APA) (5 U.S.C. 553(b)). However, 

we can waive this notice and comment 

procedure if the Secretary finds, for 

good cause, that the notice and 

comment process is impracticable, 

unnecessary, or contrary to the public 

interest, and incorporates a statement of 

the finding and the reasons therefore in 

the notice. 

Section 553(d) of the APA ordinarily 

requires a 30-day delay in effective date 

of final rules after the date of their 

publication in the Federal Register. 

This 30-day delay in effective date can 

be waived, however, if an agency finds 

for good cause that the delay is 

impracticable, unnecessary, or contrary 

to the public interest, and the agency 

incorporates a statement of the findings 

and its reasons in the rule issued. 

In our view, this correcting document 

does not constitute a rule that would be 

subject to the APA notice and comment 

or delayed effective date requirements. 

This correcting document corrects 

technical errors and typographical 

errors in the preamble, regulations text, 

tables included in the Addendum of the 

FY 2013 IPPS/LTCH PPS final rule, and 

tables posted on the CMS Web site but 

does not make substantive changes to 

the policies or payment methodologies 

that were adopted in the final rule. As 

a result, this correcting document is 

intended to ensure that the preamble, 

regulations text, tables included in the 

Addendum of the FY 2013 IPPS/LTCH 

PPS final rule, and tables posted on the 

CMS Web site accurately reflect the 

policies adopted in that final rule. 

In addition, even if this were a rule to 

which the notice and comment and 

delayed effective date requirements 

applied, we find that there is good cause 

to waive such requirements. 

Undertaking further notice and 

comment procedures to incorporate the 

corrections in this document into the 

final rule or delaying the effective date 

would be contrary to the public interest. 

Furthermore, such procedures would be 

unnecessary, as we are not altering the 

policies that were already subject to 

comment and finalized in our final rule. 

Therefore, we believe we have good 

cause to waive the notice and comment 

and effective date requirements. 


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Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations 60317 

IV. Correction of Errors 

In FR Doc. 2012–19079 of August 31, 

2012 (77 FR 53258), make the following 

corrections: 

A. Corrections of Errors in the Preamble 

1. On page 53268, 

a. First column, first partial 

paragraph, line 10, the phrase ‘‘HAC 

measures sets’’ is corrected to read ‘‘HAI 

measures sets’’. 

b. Third column, last paragraph, 

second line from the bottom, the figure 

‘‘$280’’ is corrected to read ‘‘$290’’. 

2. On page 53278, third column, first 

partial paragraph, line 32, the phrase 

‘‘in FY 2010.’’ is correct to read ‘‘in FY 

2013.’’. 

3. On page 53315, third column, last 

paragraph, line 4, the phrase ‘‘the ICD– 

9–CM coding system’’ is corrected to 

read ‘‘the ICD–9–CM diagnosis codes’’. 

4. On page 53386, third column, third 

paragraph, line 7, the phrase ‘‘for 

applicable conditions.’’ is deleted. 

5. On page 53387, third column, 

second paragraph, lines 37 and 38, the 

Web site ‘‘http://www.cms.hhs.gov/ 

LimitedDataSets/’’ is corrected to read 

‘‘http://www.cms.gov/ResearchStatistics-Data-and-Systems/Files-forOrder/LimitedDataSets/index.html’’. 

6. On page 53392, lower half of the 

page, first column, first paragraph— 

a. Line 10, the phrase ‘‘all discharges 

for applicable conditions’’ is corrected 

to read ‘‘all discharges’’. 

b. Lines 12 and 13, the phrase ‘‘all 

discharges for applicable conditions.’’ is 

corrected to read ‘‘all discharges.’’. 

7. On page 53485, second column, 

first partial paragraph— 

a. Line 26, the phrase ‘‘IPPS Hospital 

A’’ is corrected to read ‘‘IPPS Hospital 

B’’. 

b. Line 29, the phrase ‘‘LTCH B’’ is 

corrected to read ‘‘LTCH A’’. 

c. Line 31, the phrase 

‘‘§ 412.536(a)(3)(1)’’ is corrected to read 

‘‘§ 412.536(a)(3)(i)’’. 

8. On page 53508, second column, last 

paragraph, line 1, the phrase ‘‘We wish 

to clarify’’ is corrected to read ‘‘We are 

clarifying’’. 

9. On page 53545, second column, 

first partial paragraph, line 5, the 

bracketed phrase ‘‘[or catheter?]’’ is 

corrected to read ‘‘or catheter’’. 

10. On page 53557, second column, 

first full paragraph, line 2, the phrase 

‘‘with other our’’ is corrected to read 

‘‘with our other’’. 

11. On page 53601, bottom of the 

page, the table entitled ‘‘FINAL 

PERFORMANCE STANDARDS FOR 

THE FY 2015 HOSPITAL VBP 

PROGRAM CLINICAL PROCESS OF 

CARE, OUTCOME, AND EFFICIENCY 

DOMAINS,’’ the listed entry is added 

after Measure ID AMI–8a to read as 

follows: 

CLINICAL PROCESS OF CARE MEASURES

Measure ID Description Achievement 

threshold Benchmark 

HF–1 ................................................ Discharge Instructions ............................................................................... 0.94118 1.00000 

12. On page 53648, first column, first 

full paragraph, lines 9 and 10, the 

phrase ‘‘physical restraint (HBIPS–2) 

use’’ is corrected to ‘‘physical restraint 

use’’ 

13. On page 53655, third column, 

second paragraph, lines 6 and 7, the 

phrase ‘‘behavioral services in the IPF 

settings’’ is corrected to read 

‘‘behavioral health services in the IPF 

setting.’’ 

14. On page 53668, 

a. Second column, second full 

paragraph, line 9, the phrase ‘‘over 200’’ 

is corrected to read ‘‘upwards of 300’’. 

b. Third column, first partial 

paragraph, lines 17 and 18, the phrase 

‘‘321 LTCHs’’ is corrected to read 

‘‘upwards of 300 LTCHs’’. 

15. On page 53669, third column, first 

full paragraph, lines 9 through 11, the 

phrase ‘‘to comply with the reporting 

pressure ulcer data.’’ is corrected to read 

‘‘to report pressure ulcer data.’’. 

B. Corrections of Errors in the 

Addendum 

1. On page 53706, middle of the page, 

the table entitled, ‘‘COMPARISON OF 

FACTORS AND ADJUSTMENTS: FY 

2012 CAPITAL FEDERAL RATE AND 

FY 2013 CAPITAL FEDERAL RATE,’’ 

listed entry is corrected to read as 

follows: 

FY 2012 FY 2013 Change Percent 

change 

GAF/DRG Adjustment Factor 1 ........................................................................ 1.0004 0.9998 0.9998 ¥0.02 

1 The update factor and the GAF/DRG budget neutrality adjustment factors are built permanently into the capital Federal rates. Thus, for example, the incremental change from FY 2012 to FY 2013 resulting from the application of the 0.9998 GAF/DRG budget neutrality adjustment factor for FY 2013 is a net change of 0.9998 (or ¥0.02 percent). 

2. On page 53731, first column, first 

paragraph, line 28, the figure ‘‘2,206’’ is 

corrected to read ‘‘2,217’’. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 27, 2012. 

Oliver Potts, 

Deputy Executive Secretary to the 

Department, Department of Health and 

Human Services. 

[FR Doc. 2012–24307 Filed 9–28–12; 4:15 pm] 

BILLING CODE 4120–01–P 


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60318 Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket DOT–OST–2010–0026] 

RIN 2105–AE14 

Procedures for Transportation 

Workplace Drug and Alcohol Testing 

Programs: 6-acetylmorphine (6-AM) 

Testing 

AGENCY: Office of the Secretary, U.S. 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This rule adopts as final, 

without change, a May 4, 2012, interim 

final rule (IFR) which no longer requires 

laboratories and Medical Review 

Officers (MRO) to consult with one 

another regarding the testing for the 

presence of morphine when the 

laboratory confirms the presence of 6- 

acetylmorphine (6-AM). Also, 

laboratories and MROs will no longer 

need to report 6-AM results to the Office 

of Drug and Alcohol Policy and 

Compliance (ODAPC). This rule also 

responds to comments on the IFR. 

DATES: The rule is effective October 3, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Bohdan Baczara, U.S. Department of 

Transportation, Office of Drug and 

Alcohol Policy and Compliance, 1200 

New Jersey Avenue SE., Washington, 

DC 20590; 202–366–3784 (voice), 202– 

366–3897 (fax), or 

bohdan.baczara@dot.gov (email). 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

On August 16, 2010, [75 FR 49850] 

the Department published its final rule 

to harmonize with many aspects of the 

revised Department of Health and 

Human Services (HHS) Mandatory 

Guidelines [73 FR 71858]. One item 

with which the DOT harmonized was 

the laboratory testing for 6- 

acetylmorphine (6-AM) without a 

morphine marker. 6-AM is a unique 

metabolite produced when a person 

uses the illicit drug heroin. Prior to the 

October 1, 2010, rulemaking, both the 

HHS and Department of Transportation 

(DOT) regulations required the 

laboratory to first test for morphine, and 

if it detected morphine at the HHS/DOT 

cutoff of 2000ng/mL, the lab would then 

test for 6-AM. 

For the reasons discussed in the DOT 

final rule [75 FR 49850], we decided 

that, until more experience was gained 

with the new testing procedures for 6- 

AM, we would place additional 

requirements on laboratories and MROs. 

Specifically, when there was a 6-AM 

positive result and morphine was not 

detected by a laboratory at the 2000ng/ 

mL cutoff, we added a requirement for 

the laboratory and MRO to determine 

whether morphine was detected at the 

laboratory’s level of detection (LOD). If 

morphine was not detected at the 

laboratory’s LOD, the laboratory and 

MRO were to report that result to DOT’s 

Office of Drug and Alcohol Policy and 

Compliance (ODAPC). After consulting 

with ODAPC, the MRO would make a 

verified result determination, keeping in 

mind that there is no legitimate 

explanation for 6-AM in the employee’s 

specimen [see § 40.151(g)]. The 

Department would track these results 

and discuss them with HHS. 

On May 4, 2012, the Department 

issued an IFR [77 FR 26471] and 

effective July 3, 2012, related to 6-AM 

testing. For reasons stated in that IFR, 

we removed the requirement for 

laboratories and MROs to consult with 

one another regarding the testing for the 

presence of 6-AM. The IFR also 

streamlined the laboratory analysis and 

MRO reporting of 6-AM results by not 

having either the laboratory or MRO 

report the 6-AM information to ODAPC. 

The IFR also sought comments to the 

IFR which were to be submitted by June 

4, 2012. There were two such 

comments. 

Discussion of Comments to the Docket 

There were two comments to the 

docket representing three organizations. 

One comment was submitted by a large 

organization which represents 

physicians who are MROs. The other 

comment was submitted by a large 

medical review officer service and 

consortium which provide drug and 

alcohol testing services primarily to the 

pipeline industry. 

Each of the commentors fully 

supported the Department’s position on 

amending the requirements for testing 

and reporting 6-AM test results. Their 

support of the IFR further reinforces that 

there are no legitimate medical 

explanations for the confirmation of 6- 

AM on a DOT drug test and that the 

MRO must make positive results 

determinations in these cases. 

One commenter asked whether we 

had noted a spike followed by a decline 

in the 6-AM results during the first year 

of testing, as they did. They wondered 

whether our commissioned study was 

designed to shed light on their 

observation. 

We would note that over time, the 

Department has indeed seen an increase 

of laboratory-reported 6-AM test results. 

However, we found that the largest 

semi-annual period rise of 6-AM results, 

by number and percentage increase, 

came even before the October 2010 

effective date of the new rules. This 

larger rise was noted when we 

compared the July–December 2009 

period with the January–June 2010 

period. Also, it is important to note that 

the number of total drug tests reported 

by laboratories has risen during each 6- 

month period, starting with the July– 

December 2009 period, and the number 

of 6-AM positive results has steadily 

risen each period since July–December 

2008. 

The following table displays the 

laboratory data for 6-AM before, during 

transition, and after full implementation 

of the new testing protocols: 

Semi-Annual period 2008 

July–Dec 

2009 

Jan–June 

2009 

July–Dec 

2010 

Jan–June 

2010 *

July–Dec 

2011 

Jan–June 

2011 

July–Dec 

Total Laboratory Test Results.2.85 million ... 2.59 million ... 2.57 million ... 2.69 million ... 2.77 million ... 2.82 million ... 2.87 million 

6-AM Laboratory Positives .. 121 ............... 158 ............... 173 ............... 281 ............... 298 ............... 371 ............... 429 

*The new requirement for 6-AM testing was in effect for the last 3 months of the period. 


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