[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24154-24156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10964]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10553, CMS-2746, CMS-2728, and CMS-10157]


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 June 24, 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/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) 786-4669.

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

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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: Extension of a currently 
approved collection; Title of Information Collection: Medicaid Quality 
Assessment and Performance Improvement Programs, State Review of 
Accreditation Status, Medicaid Managed Care Quality Rating System, and 
Quality Strategy (QS) and Supporting Regulations; Use: Medicaid 
beneficiaries and stakeholders use the information collected and 
reported to understand the state's quality improvement goals and 
objectives, and to understand how the state is measuring progress on 
its goals. States use this information to help monitor and assess the 
performance of their Medicaid managed care programs. This information 
may assist states in comparing the outcomes of quality improvement 
efforts and can assist them in identifying future performance 
improvement subjects. CMS uses this information as a part of its 
oversight of Medicaid programs. Form Number: CMS-10553 (OMB control 
number: 0938-1281); Frequency: Yearly and occasionally; Affected 
Public: Private sector (business or other for profits) and State, 
Local, or Tribal Governments; Number of Respondents: 603; Total Annual 
Responses: 6,441; Total Annual Hours: 52,343. (For policy questions 
regarding this collection contact Barbara Dailey at 410-786-9012.)
    2. Type of Information Collection Request: Reinstatement; Title of 
Information Collection: End Stage Renal Disease Death Notification; 
Use: The ESRD Death Notification form (CMS-2746) is completed by all 
Medicare-approved ESRD facilities upon death of an ESRD patient. Its 
primary purpose is to collect fact of death and cause of death of ESRD 
patients. The ESRD Program Management and Medical Information System 
(PMMIS) has the responsibility of collecting, maintaining and 
disseminating, on a national basis, uniform data pertaining to ESRD 
patients and their treatment of care. All renal facilities approved to 
participate in the ESRD program are required by Public Law 95-292 to 
supply data to this system.
    Federal regulations require that the ESRD Networks examine the 
mortality rates of every Medicare-approved facility within its area of 
responsibility. CMS-2746 provides the necessary data to assist the ESRD 
Networks in making decisions that result in improved patient care and 
in cost-effective distribution of ESRD resources. The data is used by 
the ESRD Networks to verify facility deaths and to monitor facility 
performance. The form is also used by health care planning agencies and 
researchers to determine survival rates by diagnoses. Form Number: CMS-
2746 (OMB control number: 0938-0448); Frequency: Yearly; Affected 
Public: Private Sector (Business or other for-profits, Not-for-Profit 
Institutions); Number of Respondents: 7,311; Total Annual Responses: 
92,023; Total Annual Hours: 46,011.50. (For policy questions regarding 
this collection contact Gequinicia Polk at 410-786-2305.)
    3. Type of Information Collection Request: Reinstatement; Title of 
Information Collection: End Stage Renal Disease Medical Evidence Report 
Medicare Entitlement and/or Patient Registration; Use: In accordance 
with section 226A of the law, the primary purpose of this form is to 
have a patient medically determined, by a physician, to have end stage 
renal disease for purposes of filing for Medicare benefits. The End 
Stage Renal Disease (ESRD) Medical Evidence (CMS-2728) is completed for 
all ESRD patients either by the first treatment facility or by a 
Medicare-approved ESRD facility when it is determined by a physician 
that the patient's condition has reached that stage of renal impairment 
that a regular course of kidney dialysis or a kidney transplant is 
necessary to maintain life. The data reported on the CMS-2728 is used 
by the Federal Government, ESRD Networks, treatment facilities, 
researchers and others to monitor and assess the quality and type of 
care provided to end stage renal disease beneficiaries. Collection of 
these data are also necessary for entitlement of ESRD patients to 
Medicare benefits and also for the establishment and maintenance of a 
single, nationwide kidney disease registry for dialysis, transplant, 
and prospective transplant patients, and will store pertinent medical 
facts on each registrant. The data will enable individual practitioners 
and facilities to review, compare, and improve ESRD patient treatment 
methods, which will permit local Medical Review Boards to more 
effectively monitor utilization and quality of medical care. Form 
Number: CMS-2728 (OMB control number: 0938-0046); Frequency: Yearly; 
Affected Public: Private Sector (Business or other for-profits, Not-
for-Profit Institutions); Number of Respondents: 7,311; Total Annual 
Responses: 138,000; Total Annual Hours: 103,500. (For policy questions 
regarding this collection contact Gequinicia Polk at 410-786-2305.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: The HIPAA 
Eligibility Transaction System (HETS); Use: HIPAA regulations require 
covered entities to verify the identity of the person requesting PHI 
and the person's authority to have access to that information. Under 
the HIPAA Security rules, covered entities, regardless of their size, 
are required under 45 CFR Subtitle A, Subpart C 164.312(a)(2)(i) to 
``assign a unique name and/or number for identifying and tracking user 
identity.'' A 'user' is defined in 164.304 as a ``person or entity with 
authorized access'' Accordingly, the HIPAA Security rule requires 
covered entities to assign a unique name and/or number to each employee 
or workforce member who uses a system that receives, maintains or 
transmits electronic PHI so that system access and activity can be 
identified and tracked by user. This pertains to workforce members 
within small or large provider offices, health plans, group health 
plans, and clearinghouses. Federal law requires that CMS take 
precautions to minimize the security risk to the federal information 
system. Federal Information Processing Standards Publication (FIPS PUB) 
1() 1-2 Paragraph 11.7--Security and Authentication states that: 
``Agencies shall employ risk management techniques to determine the 
appropriate mix of security controls needed to protect specific data 
and systems. The selection of controls shall take into account 
procedures required under applicable laws and regulations.'' 
Accordingly, CMS requires that entities who wish to connect to the HETS 
application via the CMS Extranet and/or internet are uniquely 
identified. CMS is required to verify the identity of the person 
requesting the Protected Health Information (PHI) and the person's 
authority to have access to Medicare eligibility information. 
Furthermore, CMS requires that trading partners who wish to conduct 
eligibility transactions on a real-time basis with CMS provide certain 
assurances as a condition of

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receiving access to the Medicare eligibility information for the 
purpose of conducting real-time 270/271 inquiry/response transactions. 
Form Number: CMS-10157 (OMB control number: 0938-0960); Frequency: 
Yearly; Affected Public: Private Sector; Business or other for profits, 
Not-for-Profits Institutions; Number of Respondents: 1000; Total Annual 
Responses: 1000; Total Annual Hours: 250. (For policy questions 
regarding this collection contact Rupinder Singh at 410 786-7484.)

    Dated: May 21, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-10964 Filed 5-23-19; 8:45 am]
BILLING CODE 4120-01-P