[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 731-734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00433]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10330, CMS-10673, CMS-906, CMS-10433, CMS-276 
and CMS-10694 and CMS-P-0015A]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Department of Health 
and Human 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 (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 April 1, 2019.

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 ___, 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 website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    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: William N. 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-10330 Enrollment Opportunity Notice Relating to Lifetime Limits; 
Required Notice of Rescission of Coverage; and Disclosure Requirements 
for Patient Protection under the Affordable Care Act
CMS-10379 Rate Increase Disclosure and Review Requirements (45 CFR part 
154)
CMS-10673 Medicare Advantage Qualifying Payment Arrangement Incentive 
(MAQI) Demonstration
CMS-906 The Fiscal Soundness Reporting Requirements
CMS-276 Prepaid Health Plan Cost Report
CMS-10694 Testing of Web Survey Design and Administration for CMS 
Experience of Care Surveys
CMS-P-0015A Medicare Current Beneficiary Survey

    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

[[Page 732]]

collection of information, before submitting the collection to OMB for 
approval. To comply with this requirement, CMS is publishing this 
notice.

Information Collection

    1. Type of Information Collection Request: Extension; Title of 
Information Collection: Enrollment Opportunity Notice Relating to 
Lifetime Limits; Required Notice of Rescission of Coverage; and 
Disclosure Requirements for Patient Protection under the Affordable 
Care Act; Use: Sections 2712 and 2719A of the Public Health Service 
Act, as added by the Affordable Care Act, and the interim final 
regulations titled ``Patient Protection and Affordable Care Act: 
Preexisting Condition Exclusions, Lifetime and Annual Limits, 
Rescissions, and Patient Protections'' (75 FR 37188, June 28, 2010) 
contain rescission notice, and patient protection disclosure 
requirements that are subject to the Paperwork Reduction Act of 1995. 
The rescission notice will be used by health plans to provide advance 
notice to certain individuals that their coverage may be rescinded as a 
result of fraud or intentional misrepresentation of material fact. The 
patient protection notification will be used by health plans to inform 
certain individuals of their right to choose a primary care provider or 
pediatrician and to use obstetrical/gynecological services without 
prior authorization.
    The related provisions are finalized in the final regulations 
titled ``Final Rules under the Affordable Care Act for Grandfathered 
Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, 
Rescissions, Dependent Coverage, Appeals, and Patient Protections''. 
The final regulations also require that, if State law prohibits balance 
billing, or a plan or issuer is contractually responsible for any 
amounts balanced billed by an out-of-network emergency services 
provider, a plan or issuer must provide a participant, beneficiary or 
enrollee adequate and prominent notice of their lack of financial 
responsibility with respect to amounts balanced billed in order to 
prevent inadvertent payment by the individual. Form Number: CMS-10330 
(OMB control number: 0938-1094); Frequency: Occasionally; Affected 
Public: Private Sector, State, Local, or Tribal Governments; Number of 
Respondents: 920; Total Annual Responses: 71,268; Total Annual Hours: 
524. (For policy questions regarding this collection contact Usree 
Bandyopadhyay at 410-786-6650.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage Qualifying Payment Arrangement Incentive (MAQI) 
Demonstration; Use: The Centers for Medicare & Medicaid Services (CMS) 
is testing a demonstration, under Section 402 of the Social Security 
Amendments of 1967 (as amended), entitled the Medicare Advantage 
Qualifying Payment Arrangement Incentive (MAQI) Demonstration (``the 
Demonstration''). The MAQI demonstration tests whether providing 
exclusions from the Merit-based Incentive Payment System (MIPS) 
reporting requirements, payment adjustments, and performance feedback 
(collectively, the ``MIPS exclusions'') for eligible clinicians who 
participate to a sufficient degree in certain payment arrangements with 
Medicare Advantage Organizations (MAOs) (combined with participation, 
if any, in Advanced Alternative Payment Models (APMs) with Medicare 
Fee-for-Service (FFS)) will increase or maintain participation in 
payment arrangements with MAOs similar to Advanced APMs and change the 
manner in which clinicians deliver care.
    Clinicians may currently participate in one of two paths of the 
Quality Payment Program (QPP): (1) MIPS, which adjusts Medicare 
payments based on combined performance on measures of quality, cost, 
improvement activities, and advancing care information, or (2) Advanced 
Alternative Payment Models with Medicare (Advanced APMs), under which 
eligible clinicians may earn an incentive payment for sufficient 
participation in certain payment arrangements with Medicare fee-for-
service (FFS) and other payers, and starting in the 2019 performance 
period, with other payers such as Medicare Advantage, commercial 
payers, and Medicaid managed care. To participate in the Advanced APM 
path of QPP for a given year and earn an incentive payment, eligible 
clinicians must meet the criteria of Qualifying APM Participants (QPs); 
in addition to earning an APM incentive payment, QPs are excluded from 
the MIPS reporting requirements and payment adjustment.
    An eligible clinician that does not meet the criteria to be a QP 
for a given year will be subject to MIPS for that year unless the 
clinician meets certain other MIPS exclusion criteria, such as being 
newly enrolled in Medicare or meeting the low volume threshold for 
Medicare FFS patients, payments and services. The MAQI Demonstration 
allows participating eligible clinicians to have the opportunity to 
receive the MIPS exclusions for a given year if they participate to a 
sufficient degree in certain Qualifying Payment Arrangements with MAOs 
(and Advanced APMs with Medicare FFS) during the performance period for 
that year, without requiring them to be QPs or otherwise meet the MIPS 
exclusion criteria of QPP. Under this Demonstration, clinicians are not 
required to have a minimum amount of participation in an Advanced APM 
with Medicare FFS in order to receive the MIPS exclusions for a year, 
but if they did have participation in Advanced APMs with Medicare FFS, 
that participation will also be counted towards the thresholds that 
trigger the provision of MIPS exclusions under the demonstration.
    The first performance period for the Demonstration was 2018 and the 
Demonstration will last up to five years. Clinicians who meet the 
definition of an eligible clinician under QPP, as defined under 42 CFR 
414.1305, are eligible to participate in the MAQI Demonstration. 
Participation will last the duration of the Demonstration, unless 
participation is voluntarily or involuntarily terminated under the 
terms and conditions of the Demonstration. Demonstration participants 
will have the opportunity to submit the required documentation and be 
evaluated for the MIPS exclusions each year. If Demonstration 
participants submit information, but do not meet the conditions of the 
Demonstration, their participation in the Demonstration will not be 
terminated, but they will not receive the MIPS exclusions. Therefore, 
unless they become QPs or are excluded from MIPS for other reasons, the 
participating clinicians will be subject to MIPS and will face the MIPS 
payment adjustments for the applicable year.
    In order to conduct an evaluation and effectively implement the 
MAQI Demonstration, CMS must collect information from Demonstration 
participants on (a) payment arrangements with MAOs and (b) Medicare 
Advantage (MA) payments and patient counts. CMS requires a new 
collection of this information as this information is not already 
available through other sources. The information collected in these 
forms will allow CMS to evaluate whether the payment arrangement(s) 
that clinicians have with MAOs meet the Qualifying Payment Arrangement 
criteria, and determine whether a clinician's MAO and FFS APM patient 
population or payments meet demonstration thresholds. Both of these 
areas are also requirements for review and data collection under QPP 
(i.e. the Eligible Clinician-Initiated Other Payer Advanced APM 
Determination form and All-Payer QP

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Submission form), and therefore similar forms have been prepared and 
reviewed under the QPP.
    Given these similarities in forms, burden estimates for the MAQI 
Demonstration PRA package were derived from burden analyses and 
formulation done in conjunction with the QPP forms; more specifically 
the estimated burden associated with the submission of payment 
arrangement information for Other Payer Advanced APM Determinations. 
CMS estimates the total hour burden per respondent for the MAQI 
demonstration to be 15 hours or less, to match the hours listed in the 
equivalent QPP forms. Full detail of how these estimates were derived 
can be found in the published (83 FR 59452).
    Based on public comments, we have revised the collection 
instruments to include modifications to allow Taxpayer Identification 
Numbers (TIN) level participation and greater functionality for 
organization/authorized representatives to submit on behalf of their 
clinicians. Form Number: CMS-10673 (OMB control number: 0938-1354; 
Frequency: Annually; Affected Public: Business or other for-profit and 
Not-for-profit institutions; Number of Respondents: 100,000; Total 
Annual Responses: 100,000; Total Annual Hours: 1,500,000. (For policy 
questions regarding this collection contact John Amoh at 
[email protected].)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: The Fiscal 
Soundness Reporting Requirements; Use: All contracting organizations 
must submit audited annual financial statements one time per year. In 
addition, to the audited annual submission, Health Plans with a 
negative net worth and/or a net loss and the amount of that loss is 
greater than one-half of the organization's total net worth must file 
quarterly financial statements for fiscal soundness monitoring. Part D 
organizations are required to submit three (3) quarterly financial 
statements. Lastly, PACE organizations are required to file four (4) 
quarterly financial statements for the first three (3) years in the 
program. After the first three (3) years, PACE organizations with a 
negative net worth and/or a net loss and the amount of that loss is 
greater than one-half of the organization's total net worth must submit 
quarterly financial statements for fiscal soundness monitoring. CMS is 
responsible for overseeing the ongoing financial performance for all 
Medicare Health Plans, PDPs, and PACE organizations. Specifically, CMS 
needs the requested information collected in order to establish that 
contracting entities within those programs maintain fiscally sound 
operations. Form Number: CMS-906 (OMB control number: 0938-0469); 
Frequency: Yearly; Affected Public: Business or other for-profits, Not-
for profits institutions; Number of Respondents: 767; Total Annual 
Responses: 1589; Total Annual Hours: 530. (For policy questions 
regarding this collection contact Christa Zalewski at 410-786-1971.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Information 
Collection Requirements for Compliance with Individual and Group Market 
Reforms under Title XXVII of the Public Health Service Act; Use: 
Sections 2723 and 2761 of the Public Health Service Act (PHS Act) 
direct the Centers for Medicare and Medicaid Services (CMS) to enforce 
a provision (or provisions) of title XXVII of the PHS Act (including 
the implementing regulations in parts 144, 146, 147, and 148 of title 
45 of the Code of Federal Regulations) with respect to health insurance 
issuers when a state has notified CMS that it has not enacted 
legislation to enforce or that it is not otherwise enforcing a 
provision (or provisions) of the group and individual market reforms 
with respect to health insurance issuers, or when CMS has determined 
that a state is not substantially enforcing one or more of those 
provisions. Section 2723 of the PHS Act directs CMS to enforce an 
applicable provision (or applicable provisions) of title XXVII of the 
PHS Act (including the implementing regulations in parts 146 and 147 of 
title 45 of the Code of Federal Regulations) with respect to group 
health plans that are non-Federal governmental plans. This collection 
of information includes requirements that are necessary for CMS to 
conduct compliance review activities.
    The Department of the Treasury, the Department of Labor, and the 
Department of Health and Human Services (collectively, the Departments) 
issued proposed regulations titled ``Health Reimbursement Arrangements 
and Other Account-Based Group Health Plans'' under section 2711 of the 
PHS Act and the health nondiscrimination provisions of HIPAA, Public 
Law 104-191 (HIPAA nondiscrimination provisions.) The proposed 
regulations are intended to expand the usability of health 
reimbursement arrangements and other account-based group health plans 
(collectively referred to as HRAs). In general, the proposed 
regulations would expand the usability of HRAs by eliminating the 
current prohibition on integrating HRAs with individual health 
insurance coverage, thereby permitting employers to offer HRAs to 
employees enrolled in individual health insurance coverage. Under the 
proposed regulations employees would be permitted to use amounts in an 
HRA integrated with individual health insurance coverage to pay 
expenses for medical care (including premiums for individual health 
insurance coverage), subject to certain requirements. This collection 
includes the requirements related to substantiation of individual 
health insurance coverage by an HRA prior to making reimbursements and 
the notice that HRAs would be required to provide to each participant. 
Form Number: CMS-10430 (OMB control number: 0938-0702); Frequency: 
Annually; Affected Public: State Governments, Private Sector, State or 
local governments; Number of Respondents: 2,785; Total Annual 
Responses: 298,175; Total Annual Hours: 7,737. (For policy questions 
regarding this collection contact Usree Bandyopadhyay at 410-786-6650.)
    5. Type of Information Collection Request: Revision of a currently 
approved information collection; Title of Information Collection: 
Prepaid Health Plan Cost Report; Use: Health Maintenance Organizations 
and Competitive Medical Plans (HMO/CMPs) contracting with the Secretary 
under Section 1876 of the Social Security Act are required to submit a 
budget and enrollment forecast, semi-annual interim report, 4th Quarter 
interim report (CMS has waived this annual submission), and a final 
certified cost report in accordance with 42 CFR 417.572-417.576. The 
submission, receipt and processing of the cost reports is imperative to 
determine if MCOs are paid on a reasonable basis for the covered 
services furnished to Medicare enrollees. CMS reviews the data 
submitted within the cost reports to establish monthly payment rates, 
monitor interim rates, and determine the final reimbursement. Health 
Care Prepayment Plans (HCPPs) contracting with the Secretary under 
Section 1833 of the Social Security Act are required to submit a budget 
and enrollment forecast, semi-annual interim report, and final cost 
report in accordance with 42 CFR 417.808 and 42 CFR 417.810. Form 
Number: CMS-276 (OMB control number: 0938-0165); Frequency: Quarterly; 
Affected Public: Businesses or other for-profits, Not-for-profit 
institutions; Number of Respondents: 57; Total Annual Responses: 67; 
Total Annual Hours: 1,800. (For policy

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questions regarding this collection, contact Bilal Farrakh at 410-786-
4456.)
    6. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Testing 
of Web Survey Design and Administration for CMS Experience of Care 
Surveys; Use: This collection is a new generic clearance request which 
encompasses an array of research activities to add web administration 
protocols to a series of surveys conducted by the Centers for Medicare 
& Medicaid Services (CMS). This request seeks burden hours to allow CMS 
and its contractors to conduct cognitive in-depth interviews, focus 
groups, pilot tests, and usability studies to support a variety of 
methodological studies around web modes of data collection for programs 
such as the Emergency Department Experience of Care (EDPEC), Fee-for-
Service (FFS) Consumer Assessment of Healthcare Providers and Systems 
(CAHPS), Hospital CAHPS (HCAHPS), Medicare Advantage and Prescription 
Drug (MA & PDP) CAHPS, Home Health (HH) CAHPS, Hospice CAHPS, In-Center 
Hemodialysis (ICH) CAHPS, the Health Outcomes Survey (HOS), and the 
Medicare Advantage and Part D Plan Disenrollment Reasons surveys. 
Providers. Form Number: CMS-10694 (OMB control number: 0938-New); 
Frequency: Yearly; Affected Public: Business or other for-profits, Not-
for-Profit Institutions; Number of Respondents: 75,250; Total Annual 
Responses: 75,250; Total Annual Hours: 17,000. (For policy, questions 
regarding this collection contact Elizabeth H. Goldstein at 410-786-
6665.)
    7. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Current 
Beneficiary Survey; Use: CMS is the largest single payer of health care 
in the United States. The agency plays a direct or indirect role in 
administering health insurance coverage for more than 120 million 
people across the Medicare, Medicaid, CHIP, and Exchange populations. A 
critical aim for CMS is to be an effective steward, major force, and 
trustworthy partner in supporting innovative approaches to improving 
quality, accessibility, and affordability in healthcare. CMS also aims 
to put patients first in the delivery of their health care needs.
    The Medicare Current Beneficiary Survey (MCBS) is the most 
comprehensive and complete survey available on the Medicare population 
and is essential in capturing data not otherwise collected through our 
operations. The MCBS is an in-person, nationally-representative, 
longitudinal survey of Medicare beneficiaries that we sponsor and is 
directed by the Office of Enterprise Data and Analytics (OEDA). The 
survey captures beneficiary information whether aged or disabled, 
living in the community or facility, or serviced by managed care or 
fee-for-service. Data produced as part of the MCBS are enhanced with 
our administrative data (e.g. fee-for-service claims, prescription drug 
event data, enrollment, etc.) to provide users with more accurate and 
complete estimates of total health care costs and utilization. The MCBS 
has been continuously fielded for more than 26 years, encompassing over 
1 million interviews and more than 100,000 survey participants. 
Respondents participate in up to 11 interviews over a four year period. 
This gives a comprehensive picture of health care costs and utilization 
over a period of time.
    The MCBS continues to provide unique insight into the Medicare 
program and helps CMS and our external stakeholders better understand 
and evaluate the impact of existing programs and significant new policy 
initiatives. In the past, MCBS data have been used to assess potential 
changes to the Medicare program. For example, the MCBS was instrumental 
in supporting the development and implementation of the Medicare 
prescription drug benefit by providing a means to evaluate prescription 
drug costs and out-of-pocket burden for these drugs to Medicare 
beneficiaries. Beginning in 2020, this proposed revision to the 
clearance will add a few new measures to existing questionnaire 
sections. The revisions will result in a slight decrease in respondent 
burden of 4%, due to fewer projected completed cases each round. Form 
Number: CMS-P-0015A (OMB control number: 0938-0568); Frequency: 
Occasionally; Affected Public: Business or other for-profits and Not-
for-profit institutions; Number of Respondents: 13,656; Total Annual 
Responses: 35,998; Total Annual Hours: 42,610. (For policy questions 
regarding this collection contact William Long at 410-786-7927.)

    Dated: January 28, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-00433 Filed 1-30-19; 8:45 am]
 BILLING CODE 4120-01-P