Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26691 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Fire fighters ..................................................... Follow-back survey ........................................ 240 1 30/60 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–12371 Filed 6–7–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–10185, CMS– 

10336, CMS–10341, CMS–10417, CMS– 

10538, and CMS–10544] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by July 9, 2018. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare Part D 

Reporting Requirements and Supporting 

Regulations; Use: Data collected via 

Medicare Part D Reporting 

Requirements is an integral resource for 

oversight, monitoring, compliance and 

auditing activities necessary to ensure 

quality provision of the Medicare 

Prescription Drug Benefit to 

beneficiaries. Each section is reported at 

one of the following levels: Contract 

(data should be entered at the H#, S#, 

R#, or E# level) or Plan (data should be 

entered at the Plan Benefit Package (PBP 

level, e.g. Plan 001 for contract H#, R#, 

S#, or E). Sponsors should retain 

documentation and data records related 

to their data submissions. Data will be 

validated, analyzed, and utilized for 

trend reporting by the Division of 

Clinical and Operational Performance 

(DCOP) within the Medicare Drug 

Benefit and C & D Data Group. If outliers 

or other data anomalies are detected, 

DCOP will work in collaboration with 

other Divisions within CMS for followup and resolution. 

For CY2019 Reporting Requirements, 

the following 6 reporting sections will 

be reported and collected at the 

Contract-level or Plan-level: (1) 

Enrollment and Disenrollment—to 

evaluate sponsors’ processing of 

enrollment, disenrollment, and 

reinstatement requests in accordance 

with CMS requirements. (2) Medication 

Therapy Management (MTM) 

Programs—to evaluate Part D MTM 

programs, and sponsors’ adherence to 

CMS requirements. (3) Grievances—to 

assess sponsors’ compliance with timely 

and appropriate resolution of grievances 

filed by their enrollees. (4) Improving 

Drug Utilization Review Controls—to 

determine the impact of formulary-level 

edits at point of sale in sponsors’ 

processing of opioid prescriptions. (5) 

Coverage Determinations and 

Redeterminations—to assess sponsors’ 

compliance with appropriate resolution 

of coverage determinations and 

redeterminations requested by their 

enrollees. (6) Employer/Union 

Sponsored Sponsors—to ensure PDPs 

and the employer groups that contract 

with the PDPs properly utilize 

appropriate waivers and modifications. 

Form Number: CMS–10185 (OMB 

control number: 0938–0992); Frequency: 

Annually and semi-annually; Affected 

Public: Private sector (Business or other 

for-profits); Number of Respondents: 


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26692 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 

627; Total Annual Responses: 13,603; 

Total Annual Hours: 14,748. (For policy 

questions regarding this collection 

contact Chanelle Jones at 410–786– 

8008.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved information collection; Title 

of Information Collection: Medicare and 

Medicaid Programs; Electronic Health 

Record Incentive Program; Use: The 

American Recovery and Reinvestment 

Act of 2009 (Recovery Act) (Pub. L. 111– 

5) was enacted on February 17, 2009. 

The Recovery Act includes many 

measures to modernize our nation’s 

infrastructure, and improve affordable 

health care. Expanded use of health 

information technology (HIT) and 

certified electronic health record (EHR) 

technology will improve the quality and 

value of America’s health care. Title IV 

of Division B of the Recovery Act 

amends Titles XVIII and XIX of the 

Social Security Act (the Act) by 

establishing incentive payments to 

eligible professionals (EPs), eligible 

hospitals and critical access hospitals 

(CAHs), and Medicare Advantage (MA) 

organizations participating in the 

Medicare and Medicaid programs that 

adopt and successfully demonstrate 

meaningful use of certified EHR 

technology. These Recovery Act 

provisions, together with Title XIII of 

Division A of the Recovery Act, may be 

cited as the ‘‘Health Information 

Technology for Economic and Clinical 

Health Act’’ or the ‘‘HITECH Act.’’ 

The HITECH Act creates incentive 

programs for EPs and eligible hospitals, 

including CAHs, in the Medicare Feefor-Service (FFS), MA, and Medicaid 

programs that successfully demonstrate 

meaningful use of certified EHR 

technology. In their first payment year, 

Medicaid EPs and eligible hospitals may 

adopt, implement or upgrade to certified 

EHR technology. It also, provides for 

payment adjustments in the Medicare 

FFS and MA programs starting in FY 

2015 for EPs and eligible hospitals 

participating in Medicare that are not 

meaningful users of certified EHR 

technology. These payment adjustments 

do not pertain to Medicaid providers. 

The first final rule for the Medicare 

and Medicaid EHR Incentive Program, 

which was published in the Federal 

Register on July 28, 2010 (CMS–0033– 

F), specified the initial criteria EPs, 

eligible hospitals and CAHs, and MA 

organizations must meet in order to 

qualify for incentive payments; 

calculation of incentive payment 

amounts; payment adjustments under 

Medicare for covered professional 

services and inpatient hospital services 

provided by EPs, eligible hospitals and 

CAHs failing to demonstrate meaningful 

use of certified EHR technology 

beginning in 2015; and other program 

participation requirements. On the same 

date, the Office of the National 

Coordinator of Health Information 

Technology (ONC) issued a closely 

related final rule (45 CFR part 170, RIN 

0991–AB58) that specified the initial set 

of standards, implementation 

specifications, and certification criteria 

for certified EHR technology. ONC has 

also issued a separate final rule on the 

establishment of certification programs 

for health information technology (HIT) 

(45 CFR part 170, RIN 0991–AB59). The 

functionality of certified EHR 

technology should facilitate the 

implementation of meaningful use. 

Subsequently, final rules have been 

issued by CMS (77 FR 53968) and ONC 

(77 FR 72985) to create a Stage 2 of 

meaningful use criteria and other 

changes to the CMS EHR Incentive 

Programs and the 2014 Edition 

Certification Criteria for EHR 

technology. 

The information collection 

requirements contained in this 

information collection request are 

needed to implement the HITECH Act. 

In order to avoid duplicate payments, 

all EPs are enumerated through their 

National Provider Identifier (NPI), while 

all eligible hospitals and CAHs are 

enumerated through their CMS 

Certification Number (CCN). State 

Medicaid agencies and CMS use the 

provider’s tax identification number and 

NPI or CCN combination in order to 

make payment, validate payment 

eligibility and detect and prevent 

duplicate payments for EPs, eligible 

hospitals and CAHs. Form Number: 

CMS–10336 (OMB Control Number: 

0938–1158); Frequency: Occasionally; 

Affected Public: Private sector; Number 

of Respondents: 201,694; Total Annual 

Responses: 201,694; Total Annual 

Hours: 2,131,142. (For policy questions 

regarding this collection contact 

Elizabeth Holland at (410) 786–1309.) 

3. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Section 

1115 Demonstration Projects 

Regulations at 42 CFR 431.408, 431.412, 

431.420, 431.424, and 431.428; Use: 

This collection is necessary to ensure 

that states comply with regulatory and 

statutory requirements related to the 

development, implementation and 

evaluation of demonstration projects. 

States seeking waiver authority under 

Section 1115 are required to meet 

certain requirements for public notice, 

the evaluation of demonstration 

projects, and reports to the Secretary on 

the implementation of approved 

demonstrations. Form Number: CMS– 

10341 (OMB control number: 0938– 

1162); Frequency: Yearly and quarterly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

37; Total Annual Responses: 300; Total 

Annual Hours: 24,092. (For policy 

questions regarding this collection 

contact Tonya Moore at 410–786–0019.) 

4. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Medicare Feefor-Service Early Review of Medical 

Records; Use: The Medical Review 

program is designed to prevent 

improper payments in the Medicare FFS 

program. Whenever possible, MACs are 

encouraged to automate this process; 

however it may require the evaluation of 

medical records and related documents 

to determine whether Medicare claims 

were billed in compliance with 

coverage, coding, payment, and billing 

policies. 

The information required under this 

collection is requested by Medicare 

contractors to determine proper 

payment, or if there is a suspicion of 

fraud. Medicare contractors request the 

information from providers/suppliers 

submitting claims for payment when 

data analysis indicates aberrant billing 

patterns or other information which 

may present a vulnerability to the 

Medicare program. Extensive 

instructions to CMS contractors on 

medical review processes and 

procedures are contained in CMS’ 

Program Integrity Manual, 100–08 

which can be found at can be found at 

https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/internetOnly-Manuals-IOMs-Items/ 

CMS019033.html. Form Number: CMS– 

10417 (OMB control number: 0938– 

0969); Frequency: Occasionally; 

Affected Public: Private Sector (Business 

or other for-profits; Not-for-profit 

institutions; Number of Respondents: 

2,410,278; Total Annual Responses: 

2,410,278; Total Annual Hours: 

1,197,189. (For policy questions 

regarding this collection contact Daniel 

Schwartz at 410–786–4197.) 

5. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Hospice 

Information for Medicare Part D Plans; 

Use: The form would be completed by 

the prescriber or the beneficiary’s 

hospice, or if the prescriber or hospice 

provides the information verbally to the 

Part D sponsor, the form would be 

completed by the sponsor. Information 

provided on the form would be used by 

the Part D sponsor to establish coverage 


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Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26693 

of the drug under Medicare Part D. Per 

statute, drugs that are necessary for the 

palliation and management of the 

terminal illness and related conditions 

are not eligible for payment under Part 

D. The standard form provides a vehicle 

for the hospice provider, prescriber or 

sponsor to document that the drug 

prescribed is ‘‘unrelated’’ to the 

terminal illness and related conditions. 

It also gives a hospice organization the 

option to communicate a beneficiary’s 

change in hospice status and care plan 

to Part D sponsors. Form Number: CMS– 

10538 (OMB control number: 0938– 

1269); Frequency: Occasionally; 

Affected Public: Private sector (business 

or other for-profits); Number of 

Respondents: 424; Total Annual 

Responses: 376,487; Total Annual 

Hours: 31,374. (For policy questions 

regarding this collection contact Shelly 

Winston at 410–786–3694.) 

6. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Good 

Cause Processes; Use: Section 

1851(g)(3)(B)(i) of the Act provides that 

MA organizations may terminate the 

enrollment of individuals who fail to 

pay basic and supplemental premiums 

after a grace period established by the 

plan. Section 1860D–1(b)(1)(B)(v) of the 

Act generally directs us to establish 

rules related to enrollment, disenrollment, and termination for Part D 

plan sponsors that are similar to those 

established for MA organizations under 

section 1851 of the Act. Consistent with 

these sections of the Act, subpart B in 

each of the Parts C and D regulations 

sets forth requirements with respect to 

involuntary dis-enrollment procedures 

at 42 CFR 422.74 and 423.44, 

respectively. In addition, section 

1876(c)(3)(B) establishes that 

individuals may be dis-enrolled from 

coverage as specified in regulations. 

Thus, current regulations at 42 CFR 

417.460 specify that a cost plan, 

specifically a Health Maintenance 

Organization (HMO) or competitive 

medical plan (CMP), may dis-enroll a 

member who fails to pay premiums or 

other charges imposed by the plan for 

deductible and coinsurance amounts. 

Within these regulatory provisions, 

individuals dis-enrolled for 

nonpayment of premiums are afforded a 

grace period in which to request 

reinstatement. As part of the 

reinstatement request process, they 

must demonstrate good cause for failure 

to pay within the initial grace period 

that led to their involuntary disenrollment and pay all overdue 

premiums within three calendar months 

after the dis-enrollment date. Form 

Number: CMS–10544 (OMB control 

number: 0938–1271); Frequency: 

Reporting—Monthly; Affected Public: 

Private Sector (Business or other forprofit institutions); Number of 

Respondents: 10,008; Total Annual 

Responses: 10,008; Total Annual Hours: 

6,665. (For policy questions regarding 

this collection contact Carla Patterson at 

410–786–1000.) 

Dated: June 5, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–12393 Filed 6–7–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10418] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

August 7, 2018. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

https://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReducti

onActof1995/PRA-Listing.html. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10418 Annual MLR and Rebate 

Calculation Report and MLR Rebate 

Notices 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 


amozie on DSK3GDR082PROD with NOTICES1