[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26691-26693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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