[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 734-737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-R-262, CMS-224-14, CMS-R-240, CMS-10164, 
CMS-2552-10, CMS-R-306, CMS-10684, CMS-10237, CMS-10524 and CMS-10511]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

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 March 4, 2019.

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 website address at https://
www.cms.gov/Regulations-and-Guidance/Legislation/

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PaperworkReductionActof1995/PRA-Listing.html.
    1. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    2. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William Parham 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: Contract Year 
2020 Plan Benefit Package (PBP) Software and Formulary Submission; Use: 
CMS requires that MA and PDP organizations submit a completed Plan 
Benefit Package (PBP) and formulary as part of the annual bidding 
process. During this process, organizations prepare their proposed plan 
benefit packages for the upcoming contract year and submit them to CMS 
for review and approval. The plan benefit package submission consists 
of the Plan Benefit Package (PBP) software, formulary file, and 
supporting documentation, as necessary. MA and PDP organizations use 
the PBP software to describe their organization's plan benefit 
packages, including information on premiums, cost sharing, 
authorization rules, and supplemental benefits. They also generate a 
formulary to describe their list of drugs, including information on 
prior authorization, step therapy, tiering, and quantity limits. 
Additionally, CMS uses the PBP and formulary data to review and approve 
the plan benefit packages proposed by each MA and PDP organization. 
This allows CMS to review the benefit packages in a consistent way 
across all submitted bids during with incredibly tight timeframes. This 
data is also used to populate data on Medicare Plan Finder, which 
allows beneficiaries to access and compare Medicare Advantage and 
Prescription Drug plans. Form Number: CMS-R-262 (OMB control number 
0938-0763); Frequency: Yearly; Affected Public: Private Sector, 
Business or other for-profits and Not-for-profit institution; Number of 
Respondents: 570; Total Annual Responses: 6,760; Total Annual Hours: 
65,354.50 (For policy questions regarding this collection contact 
Kristy Holtje at 410-786-2209.)
    2. Title of Information Collection: Federal Qualified Health Center 
Cost Report; Type of Information Collection Request: Extension of a 
currently approved collection; Use: Under the authority of sections 
1815(a) and 1833(e) of the Act, CMS requires that providers of services 
participating in the Medicare program submit information to determine 
costs for health care services rendered to Medicare beneficiaries. 
Furthermore, these sections of the Act provide that no Medicare 
payments will be made to a provider unless it furnishes the 
information. CMS requires that providers follow reasonable cost 
principles under 1861(v)(1)(A) of the Act when completing the Medicare 
cost report. Under the regulations at 42 CFR 413.20 and 413.24, CMS 
defines adequate cost data and requires cost reports from providers on 
an annual basis. The Form CMS-224-14 cost report is needed to determine 
a provider's reasonable cost incurred in furnishing medical services to 
Medicare beneficiaries and to calculate the FQHC settlement amount. 
These providers, paid under the FQHC prospective payment system (PPS), 
may receive reimbursement outside of the PPS for Medicare reimbursable 
bad debts and pneumococcal and influenza vaccines. The FQHC cost report 
is also used for rate setting and payment refinement activities, 
including developing a FQHC market basket. Additionally, the Medicare 
Payment Advisory Commission (MedPAC) uses the FQHC Medicare cost report 
data to calculate Medicare margins, to formulate recommendations to 
Congress regarding the FQHC PPS, and to conduct additional analysis of 
the FQHC PPS. Form Number: CMS-224-14 (OMB control number: 0938-1298); 
Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 2,240; Number of Responses: 2,240; 
Total Annual Hours: 129,920. (For questions regarding this collection 
contact Julie Stankivic at (410) 786-5725.)
    3. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Prospective Payments for Hospital Outpatient Services; Use: Section 
1833(t) of the Act, as added by section 4523 of the Balanced Budget Act 
of 1997 (the BBA) requires the Secretary to establish a prospective 
payment system (PPS) for hospital outpatient services. Successful 
implementation of an outpatient PPS requires that CMS distinguish 
facilities or organizations that function as departments of hospitals 
from those that are freestanding, so that CMS can determine which 
services should be paid under the OPPS, the clinical laboratory fee 
schedule, or other payment provisions applicable to services furnished 
to hospital outpatients. Information from the reports required under 
sections 413.65(b)(3) and (c) is needed to make these determinations. 
In addition, section 1866(b)(2) of the Act authorizes hospitals and 
other providers to impose deductible and coinsurance charges for 
facility services, but does not allow such charges by facilities or 
organizations which are not provider-based. Implementation of this 
provision requires that CMS have information from the required reports, 
so it can determine which facilities are provider-based. Form Number: 
CMS-R-240 (OMB control number: 0938-0798); Frequency: Yearly; Affected 
Public: Private Sector (Business or other for-profits, Not-for-Profit 
Institutions); Number of Respondents: 750; Total Annual Responses: 
13,649,150; Total Annual Hours: 680,920 (For policy questions regarding 
this collection contact Emily Lipkin at 410-786-3633.)
    4. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Medicare EDI Enrollment Form and EDI Registration; Use: The Congress, 
recognizing the need to simplify the administration of health care 
transactions, enacted the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA), Public Law 104-191, on August 21, 
1996. Title II, Subtitle F of this legislation directs the Secretary of 
the Department of Health and Human Services to develop unique standards 
for specified electronic transactions and code sets for those 
transactions. The purpose of this Subtitle is to improve the Medicare 
and Medicaid programs in particular and the efficiency and

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effectiveness of the health care industry in general through the 
establishment of standards and requirements to facilitate the 
electronic transmission of certain health information. This Subtitle 
also requires that the Secretary adopt standards for financial and 
administrative transactions, and data elements for those transactions 
to enable health information to be exchanged electronically. The 
Standards for Electronic Transactions final rule, 45 CFR part 162 
subpart K 162.1101 through subpart R 162.1802, (hereinafter referred to 
as ``Transactions Rule'') published August 17, 2000 adopted standards 
for health care transactions and code sets. Subsequent to the 
Transactions Rule, CMS-0003-P and CMS-0005-P proposed modifications to 
the adopted standards essential to permit initial implementation of the 
standards throughout the entire healthcare industry.
    Currently, Medicare contractors have a process in place to enroll 
providers for electronic billing and other EDI transactions. In support 
of the HIPAA Transactions Rule, the purpose of this Paperwork Reduction 
Act (PRA) request is to establish a common form that is sufficient to 
address all HIPAA transactions. Form Number: CMS-10164 (OMB control 
number: 0938-0983); Frequency: Hourly; Affected Public: Private Sector 
(Business or other for-profits, Not-for-Profit Institutions); Number of 
Respondents: 193,268; Number of Responses: 193,268; Total Annual Hours: 
64,423. (For policy questions regarding this collection, contact Matt 
Klischer at 410-786-7488.)
    5. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Hospitals and 
Health Care Complex Cost Report; Use: Under the authority of sections 
1815(a) and 1833(e) of the Act, CMS requires that providers of services 
participating in the Medicare program submit information to determine 
costs for health care services rendered to Medicare beneficiaries. CMS 
requires that providers follow reasonable cost principles under 
1861(v)(1)(A) of the Act when completing the Medicare cost report. 
Under the regulations at 42 CFR 413.20 and 413.24, CMS defines adequate 
cost data and requires cost reports from providers on an annual basis. 
The Form CMS-2552-10 cost report is needed to determine a provider's 
reasonable cost incurred in furnishing medical services to Medicare 
beneficiaries and calculate the hospital settlement amounts. These 
providers, paid under the inpatient prospective payment system (IPPS) 
and the outpatient prospective payment system (OPPS), may receive 
reimbursement outside of the PPS for hospital-specific adjustments such 
as Medicare reimbursable bad debts, disproportionate share, 
uncompensated care, direct and indirect medical education costs, and 
organ acquisition costs. The Form CMS-2552-10 cost report is also used 
for rate setting and payment refinement activities, including 
developing a hospital market basket. Additionally, the Medicare Payment 
Advisory Commission (MedPAC) uses the hospital cost report data to 
calculate Medicare margins, to formulate recommendations to Congress 
regarding the IPPS and OPPS, and to conduct additional analysis of the 
IPPS and OPPS. Form Number: CMS-2552-10 (OMB control number: 0938-
0050); Frequency: Yearly; Affected Public: Private Sector (Business or 
other For-profit and Not-for-profit institutions), State, Local and 
Tribal Governments, Federal Government; Number of Respondents: 6,088; 
Total Annual Responses: 6,088; Total Annual Hours: 4,097,224. (For 
policy questions regarding this collection contact Gail Duncan at 410-
786-7278.)
    6. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: Use of 
Restraint and Seclusion in Psychiatric Residential Treatment Facilities 
(PRTFs) for Individuals Under Age 21 and Supporting Regulations; Use: 
Psychiatric residential treatment facilities are required to report 
deaths, serious injuries and attempted suicides to the State Medicaid 
Agency and the Protection and Advocacy Organization. They are also 
required to provide residents the restraint and seclusion policy in 
writing, and to document in the residents' records all activities 
involving the use of restraint and seclusion. Form Number: CMS-R-306 
(OMB control number: 0938-0833); Frequency: Occasionally; Affected 
Public: Private sector (Business or other for-profits); Number of 
Respondents: 390; Total Annual Responses: 1,466,823; Total Annual 
Hours: 449,609. (For policy questions regarding this collection contact 
Kirsten Jensen at 410-786-8146.)
    7. Type of Information Collection Request: New collection (request 
for a new OMB control number); Title of Information Collection: 21st 
Century Cures Act Section 12002 IMD Study; Use: The Act requires that 
HHS conduct a study of the effects of the 2016 Medicaid Managed Care 
final rule's provisions that clarified policy on coverage of IMD 
services in lieu of other covered services. The survey is needed to 
help answer the 5 mandated study questions. The collected data will be 
used by CMS develop a Report to Congress as required by the Act. Form 
Number: CMS-10684 (OMB Control Number: 0938-TBD); Frequency: Yearly; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 43; Number of Responses: 43; Total Annual Hours: 86. (For 
questions regarding this collection contact Laura Snyder at (410) 786-
3198.)
    8. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage Application--Part C and 1876 Cost Plan Expansion Application 
Regulations under 42 CFR 422 (Subpart K) & 417.400; Use: The Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) 
Public Law 108-173 established the Medicare Prescription Drug Benefit 
Program (Part D) and made revisions to the provisions of Medicare Part 
C, governing what is now called the Medicare Advantage (MA) program 
(formerly Medicare+Choice). The MMA directed that important aspects of 
the new Medicare Prescription Drug Benefit Program under Part D be 
similar to and coordinated with regulations for the MA program. The MMA 
changes made managed care more accessible, efficient, and attractive to 
beneficiaries seeking options to meet their needs.
    This information collection includes the process for organizations 
wishing to provide healthcare services under MA plans. These 
organizations must complete an application annually (if required), file 
a bid, and receive final approval from CMS. The MA application process 
has two options for applicants that include (1) request for new MA 
product or (2) request for expanding the service area of an existing 
product. CMS utilizes the application process as the means to review, 
assess and determine if applicants are compliant with the current 
requirements for participation in the MA program and to make a decision 
related to contract award. This collection process is the only 
mechanism for organizations to complete the required MA application 
process. CMS will collect and review information under the solicitation 
of Part C applications for the various health plan product types 
described in the Background section above. CMS will use the information 
to determine whether the applicants meet the requirements to become an 
MA organization and are qualified to provide a particular type of MA 
plan.

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The application process is open to all health plans that want to 
participate in the MA program. The application is distinct and separate 
from the bid process, and CMS issues a determination on the application 
prior to bid submissions, or before the first Monday in June. Form 
Number: CMS-10137 (OMB control number: 0938-0935); Frequency: Annually; 
Affected Public: Private Sector (Business or other for-profits, Not-
for-Profit Institutions); Number of Respondents: 380; Total Annual 
Responses: 400; Total Annual Hours: 6,106. (For policy questions 
regarding this collection contact Keith Penn-Jones, at 410-786-3104.)
    9. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Program; 
Prior Authorization Process for Certain Durable Medical Equipment, 
Prosthetic, Orthotics, and Supplies (DMEPOS); Use: The CMS has had 
longstanding concerns about the improper payments related to DMEPOS 
items. The Department of Health and Human Services' Office of the 
Inspector General and the U.S. Government Accountability Office have 
published multiple reports indicating questionable billing practices by 
suppliers, inappropriate Medicare payments, and questionable 
utilization of DMEPOS items. The fiscal year (FY) 2017 Medicare FFS 
program improper payment rate for the Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies (DMEPOS) was 44.6%, accounting for 
over $3.7 billion in projected improper payments. The CMS has 
implemented several initiatives in recent years to address these 
issues, such as the DMEPOS Competitive Bidding Program, as well as 
heightened screening of suppliers, as authorized by the Affordable Care 
Act. In addition to those actions, CMS is continuing the use of prior 
authorization in fee for service Medicare. Prior authorization is a 
process through which a request for provisional affirmation of coverage 
is submitted for review before an item is rendered to a Medicare 
patient and before a claim is submitted for payment. Prior 
authorization helps make sure that applicable Medicare coverage, 
payment, and coding rules are met before item(s) are rendered. Prior to 
furnishing the item to the beneficiary and prior to submitting the 
claim for processing, a requester must submit a prior authorization 
request that includes evidence that the item complies with all 
applicable Medicare coverage, coding, and payment rules. Consistent 
with Sec.  414.234(d), such evidence must include the order, relevant 
information from the beneficiary's medical record, and relevant 
supplier-produced documentation. After receipt of all applicable 
required Medicare documentation, CMS or one of its review contractors 
will conduct a medical review and communicate a decision that 
provisionally affirms or non-affirms the request. A provisional 
affirmative decision is a preliminary finding that a future claim 
submitted to Medicare for the DMEPOS item likely meets Medicare's 
coverage, coding, and payment requirements. Suppliers who receive a 
non-affirmative decision have unlimited resubmission opportunities. 
Form Number: CMS-10524 (OMB control number: 0938-1293); Frequency: 
Occasionally; Affected Public: Private Sector (Business or other for-
profits, Not-for-Profit Institutions); Number of Respondents: 321,551; 
Total Annual Responses: 321,551; Total Annual Hours: 160,775.68 (For 
policy questions regarding this collection contact Yuliya Cook at (410) 
786-0157.)
    10. Type of Information Collection Request: Reinstatement; Title of 
Information Collection: Medicare Coverage of Items and Services in FDA 
Investigational Device Exemption Clinical Studies--Revision of Medicare 
Coverage; Use . Section 1862(m) of the Social Security Act (and 
regulations at 42 CFR Subpart B (sections 405.201-405.215) allows for 
payment of the routine costs of care furnished to Medicare 
beneficiaries in a Category A investigational device exemption (IDE) 
study and authorizes the Secretary to establish criteria to ensure that 
Category A IDE trials conform to appropriate scientific and ethical 
standards. Medicare does not cover the Category A device itself because 
Category A (Experimental) devices do not satisfy the statutory 
requirement that Medicare pay for devices determined to be reasonable 
and necessary. Medicare may cover Category B (Non-experimental) 
devices, and associated routine costs of care, if they are considered 
reasonable and necessary and if all other applicable Medicare coverage 
requirements are met.
    Under the current centralized review process, interested parties 
(such as study sponsors) that wish to seek Medicare coverage related to 
Category A or B IDE studies have a centralized point of contact for 
submission, review and determination of Medicare coverage IDE study 
requests. In order for CMS (or its designated entity) to determine if 
the Medicare coverage criteria are met, as described in our 
regulations, CMS (or its designated entity) must review documents 
submitted by interested parties or study sponsors. Such information 
submitted will be a FDA IDE approval letter, IDE study protocol, IRB 
approval letter, National Clinical Trials (NCT) number, and Supporting 
materials as needed. Form Number: CMS-10511 (OMB control number: 0938-
1250); Frequency: Yearly; Affected Public: Private Sector (Business or 
other for-profits, Not-for-Profit Institutions); Number of Respondents: 
100; Total Annual Responses: 100; Total Annual Hours: 200. (For policy 
questions regarding this collection contact Cheryl Gilbreath at 410-
786-5919.)

    Dated: January 28, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-00411 Filed 1-30-19; 8:45 am]
 BILLING CODE 4120-01-P