83 FR 26691 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

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

Federal Register Volume 83, Issue 111 (June 8, 2018)

Page Range		26691-26693
FR Document		2018-12393

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.

Federal Register, Volume 83 Issue 111 (Friday, June 8, 2018)

[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26691-26693]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12393]


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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: 
[email protected].
    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 [email protected].
    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 follow-up 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:

[[Page 26692]]

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 Fee-for-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 Fee-for-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-and-Guidance/Guidance/Manuals/internet-Only-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

[[Page 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, 
dis-enrollment, 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 dis-enrollment 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 for-profit 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

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

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)

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

Jeffrey M. Zirger, please reference the document identifier Medicare Part D Reporting
Acting Chief, Information Collection Review or OMB control number. To be assured Requirements is an integral resource for
Office, Office of Scientific Integrity, Office consideration, comments and oversight, monitoring, compliance and
of the Associate Director for Science, Office recommendations must be received by auditing activities necessary to ensure
of the Director, Centers for Disease Control the OMB desk officer via one of the quality provision of the Medicare
and Prevention.
following transmissions: OMB, Office of Prescription Drug Benefit to
[FR Doc. 2018–12371 Filed 6–7–18; 8:45 am] Information and Regulatory Affairs, beneficiaries. Each section is reported at
BILLING CODE 4163–18–P Attention: CMS Desk Officer, Fax one of the following levels: Contract
Number: (202) 395–5806 OR Email: (data should be entered at the H#, S#,
OIRA_submission@omb.eop.gov. R#, or E# level) or Plan (data should be
DEPARTMENT OF HEALTH AND To obtain copies of a supporting entered at the Plan Benefit Package (PBP
HUMAN SERVICES statement and any related forms for the level, e.g. Plan 001 for contract H#, R#,
proposed collection(s) summarized in S#, or E). Sponsors should retain
Centers for Medicare & Medicaid
this notice, you may make your request documentation and data records related
Services
using one of following: to their data submissions. Data will be
[Document Identifiers CMS–10185, CMS– 1. Access CMS’ website address at validated, analyzed, and utilized for
10336, CMS–10341, CMS–10417, CMS– http://www.cms.hhs.gov/ trend reporting by the Division of
10538, and CMS–10544] PaperworkReductionActof1995. Clinical and Operational Performance
2. Email your request, including your (DCOP) within the Medicare Drug
Agency Information Collection address, phone number, OMB number,
Activities: Submission for OMB Benefit and C & D Data Group. If outliers
and CMS document identifier, to or other data anomalies are detected,
Review; Comment Request Paperwork@cms.hhs.gov. DCOP will work in collaboration with
AGENCY: Centers for Medicare & 3. Call the Reports Clearance Office at other Divisions within CMS for follow-
Medicaid Services. (410) 786–1326. up and resolution.
ACTION: Notice. FOR FURTHER INFORMATION CONTACT: For CY2019 Reporting Requirements,
Reports Clearance Office at (410) 786– the following 6 reporting sections will
SUMMARY: The Centers for Medicare & 1326. be reported and collected at the
Medicaid Services (CMS) is announcing SUPPLEMENTARY INFORMATION: Under the Contract-level or Plan-level: (1)
an opportunity for the public to Paperwork Reduction Act of 1995 (PRA) Enrollment and Disenrollment—to
comment on CMS’ intention to collect (44 U.S.C. 3501–3520), federal agencies evaluate sponsors’ processing of
information from the public. Under the must obtain approval from the Office of enrollment, disenrollment, and
Paperwork Reduction Act of 1995 Management and Budget (OMB) for each reinstatement requests in accordance
(PRA), federal agencies are required to collection of information they conduct with CMS requirements. (2) Medication
publish notice in the Federal Register or sponsor. The term ‘‘collection of Therapy Management (MTM)
concerning each proposed collection of information’’ is defined in 44 U.S.C. Programs—to evaluate Part D MTM
information, including each proposed 3502(3) and 5 CFR 1320.3(c) and programs, and sponsors’ adherence to
extension or reinstatement of an existing includes agency requests or CMS requirements. (3) Grievances—to
collection of information, and to allow assess sponsors’ compliance with timely
requirements that members of the public
a second opportunity for public and appropriate resolution of grievances
submit reports, keep records, or provide
comment on the notice. Interested filed by their enrollees. (4) Improving
information to a third party. Section
persons are invited to send comments Drug Utilization Review Controls—to
3506(c)(2)(A) of the PRA (44 U.S.C.
regarding the burden estimate or any determine the impact of formulary-level
3506(c)(2)(A)) requires federal agencies
other aspect of this collection of edits at point of sale in sponsors’
to publish a 30-day notice in the
information, including the necessity and processing of opioid prescriptions. (5)
Federal Register concerning each
utility of the proposed information Coverage Determinations and
proposed collection of information,
collection for the proper performance of Redeterminations—to assess sponsors’
including each proposed extension or
the agency’s functions, the accuracy of compliance with appropriate resolution
reinstatement of an existing collection
the estimated burden, ways to enhance of coverage determinations and
of information, before submitting the
the quality, utility, and clarity of the redeterminations requested by their
collection to OMB for approval. To
information to be collected and the use enrollees. (6) Employer/Union
comply with this requirement, CMS is
of automated collection techniques or Sponsored Sponsors—to ensure PDPs
publishing this notice that summarizes
other forms of information technology to and the employer groups that contract
the following proposed collection(s) of
amozie on DSK3GDR082PROD with NOTICES1

minimize the information collection with the PDPs properly utilize
information for public comment:
burden. 1. Type of Information Collection appropriate waivers and modifications.
DATES: Comments on the collection(s) of Request: Revision of a currently Form Number: CMS–10185 (OMB
information must be received by the approved collection; Title of control number: 0938–0992); Frequency:
OMB desk officer by July 9, 2018. Information Collection: Medicare Part D Annually and semi-annually; Affected
ADDRESSES: When commenting on the Reporting Requirements and Supporting Public: Private sector (Business or other
proposed information collections, Regulations; Use: Data collected via for-profits); Number of Respondents:

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Document Created: 2018-06-08 01:22:57
Document Modified: 2018-06-08 01:22:57

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on the collection(s) of information must be received by the OMB desk officer by July 9, 2018.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		83 FR 26691

83 FR 26691 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 83, Issue 111 (June 8, 2018)

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