[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)]
[Notices]
[Pages 32667-32669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10531, CMS-R-43, CMS-10102, CMS-10143, CMS-
10261, CMS-10500, and CMS-855I]


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 August 13, 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: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Transcatheter Mitral Valve Repair (TMVR) National Coverage 
Decision (NCD); Use: The data collection is required by the Centers for 
Medicare and Medicaid Services (CMS) National Coverage Determination 
(NCD) entitled, ``Transcatheter Mitral Valve Repair (TMVR)''. The TMVR 
device is only covered when specific conditions are met including that 
the heart team and hospital are submitting data in a prospective, 
national, audited registry. The data includes patient, practitioner and 
facility level variables that predict outcomes such as all-cause 
mortality and quality of life. In order to remove the data collection 
requirement under this coverage with evidence development (CED) NCD or 
make any other changes to the existing policy, we

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must formally reopen and reconsider the policy. We are continuing to 
review and analyze the data collected since this NCD was effective in 
2014
    We find that the Society of Thoracic Surgery/American College of 
Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one 
registry overseen by the National Cardiovascular Data Registry, meets 
the requirements specified in the NCD on TMVR. The TVT Registry will 
support a national surveillance system to monitor the safety and 
efficacy of the TMVR technologies for the treatment of mitral 
regurgitation (MR).
    The data collected and analyzed in the TVT Registry will be used by 
CMS to determine if the TMVR is reasonable and necessary (e.g., 
improves health outcomes) for Medicare beneficiaries under section 
1862(a)(1)(A) of the Act. The data will also include the variables on 
the eight item Kansas City Cardiomyopathy Questionnaire (KCCQ-10) to 
assess heath status, functioning and quality of life. In the KCCQ, an 
overall summary score can be derived from the physical function, 
symptoms (frequency and severity), social function and quality of life 
domains. For each domain, the validity, reproducibility, responsiveness 
and interpretability have been independently established. Scores are 
transformed to a range of 0-100, in which higher scores reflect better 
health status.
    The conduct of the STS/ACC TVT Registry and the KCCQ-10 is pursuant 
to Section 1142 of the Social Security Act (the ACT) that describes the 
authority of the Agency for Healthcare Research and Quality (AHRQ). 
Under section 1142, research may be conducted and supported on the 
outcomes, effectiveness, and appropriateness of health care services 
and procedures to identify the manner in which disease, disorders, and 
other health conditions can be prevented, diagnosed, treated, and 
managed clinically. Section 1862(a)(1)(E) of the Act allows Medicare to 
cover under coverage with evidence development (CED) certain items or 
services for which the evidence is not adequate to support coverage 
under section 1862(a)(1)(A) and where additional data gathered in the 
context of a clinical setting would further clarify the impact of these 
items and services on the health of beneficiaries. Form Number: CMS-
10531 (OMB control number: 0938-1274); Frequency: Annually; Affected 
Public: Private sector (Business or other for-profits); Number of 
Respondents: 3,897; Total Annual Responses: 15,588; Total Annual Hours: 
5,456. (For policy questions regarding this collection contact Sarah 
Fulton at 410-786-2749.)
    2. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Conditions of Coverage for Portable X-ray Suppliers and 
Supporting Regulations; Use: The requirements contained in this 
information collection request are classified as conditions of 
participation or conditions for coverage. Portable X-rays are basic 
radiology studies (predominately chest and extremity X-rays) performed 
on patients in skilled nursing facilities, residents of long-term care 
facilities and homebound patients. The CoPs are based on criteria 
described in the law, and are designed to ensure that each portable X-
ray supplier has properly trained staff and provides the appropriate 
type and level of care for patients. We use these conditions to certify 
suppliers of portable X-ray services wishing to participate in the 
Medicare program. This is standard medical practice and is necessary in 
order to help to ensure the well-being, safety and quality professional 
medical treatment accountability for each patient. There is a 
significant increase in the burden due to burden that was not accounted 
for in the previous information collection request. Form Number: CMS-R-
43 (OMB Control number: 0938-0338); Frequency: Yearly; Affected Public: 
Business or other for-profit and Not-for-profit institutions; Number of 
Respondents: 5,986,509; Total Annual Responses: 5,987,018; Total Annual 
Hours: 532,959. (For policy questions regarding this collections 
contact Sonia Swancy at 410-786-8445.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: National 
Implementation of the Hospital CAHPS Survey; Use: The HCAHPS (Hospital 
Consumer Assessment of Healthcare Providers and Systems) Survey, also 
known as the CAHPS[supreg] Hospital Survey or Hospital CAHPS[supreg], 
is a standardized survey instrument and data collection methodology 
that has been in use since 2006 to measure patients' perspectives of 
hospital care. While many hospitals collect information on patient 
satisfaction, HCAHPS created a national standard for the collection and 
public reporting of information that enables valid comparisons to be 
made across all hospitals to support consumer choice. Form Number: CMS-
10102 (OMB control number 0938-0981); Frequency: Occasionally; Affected 
Public: Private sector (Business or other for-profits and Not-for-
profit institutions); Number of Respondents: 4,200; Total Annual 
Responses: 3,100,000; Total Annual Hours: 413,230. (For policy 
questions regarding this collection contact William Lehrman at 410-786-
1037.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: State Data for 
the Medicare Modernization Act (MMA); Use: The monthly data file is 
provided to CMS by states on dual eligible beneficiaries. The phase-
down process requires a monthly count of all full benefit dual eligible 
beneficiaries with an active Part D plan enrollment in the month. CMS 
will make this selection of records using dual eligibility status codes 
contained in the person-month record to identify all full-benefit dual 
eligible beneficiaries (codes 02, 04 and 08). In the case where in a 
given month, multiple records were submitted for the same beneficiary 
in multiple file submittals, the last record submitted for that 
beneficiary shall be used to determine the final effect on the phase-
down count. Form Number: CMS-10143 (OMB Control Number: 0938-0958); 
Frequency: Monthly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 51; Total Annual Responses: 612; 
Total Annual Hours: 4,896. (For policy questions regarding this 
collection contact Linda King at 410-786-1312.)
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Part C Medicare 
Advantage Reporting Requirements and Supporting Regulations in 42 CFR 
422.516(a); Use: Medicare Advantage Organizations (MAOs) must have an 
effective procedure to develop, compile, evaluate, and report to CMS, 
to its enrollees, and to the general public, at the times and in the 
manner that CMS requires, and while safeguarding the confidentiality of 
the doctor-patient relationship, statistics and other information with 
respect to: The cost of its operations; the patterns of service 
utilization; the availability, accessibility, and acceptability of its 
services; to the extent practical, developments in the health status of 
its enrollees; information demonstrating that the MAO has a fiscally 
sound operation; and other matters that CMS may require. CMS also has 
oversight authority over cost plans which includes establishment of 
reporting requirements. The changes for the 2019 reporting requirements 
under Organization Determinations and Reconsiderations (ODR) will add 
18 new data elements to the reporting section. The new data elements 
will

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allow CMS to obtain more information about who is submitting requests 
for ODR and whether the service or claim is being provided by a 
contract or non-contract provider. The timeliness requirement for ODR 
will also be eliminated to be consistent with Part D reporting. In 
addition, the number of data reporting elements of grievances is 
reduced from 23 to 19. The reporting sections for Private Fee For 
Service (PFFS) Payment Dispute Resolution Process and Mid-Year Network 
Changes will also be suspended. Form Number: CMS-10261 (OMB control 
number: 0938-1054); Frequency: Yearly and semi-annually; Affected 
Public: Private sector (business or other for-profits); Number of 
Respondents: 432; Total Annual Responses: 3,024; Total Annual Hours: 
127,329. (For policy questions regarding this collection contact Maria 
Sotirelis at 410-786-0552.)
    6. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Consumer 
Assessment of Healthcare Providers and Systems Outpatient and 
Ambulatory Surgery (OAS CAHPS) Survey; Use: The information collected 
in the national implementation of Outpatient/Ambulatory Surgery Patient 
Experience of Care Survey (A/ASPECS) will be used to: (1) Provide a 
source of information from which selected measures can be publicly 
reported to beneficiaries to help them make informed decisions for 
outpatient surgery facility selection; (2) aid facilities with their 
internal quality improvement efforts and external benchmarking with 
other facilities; and (3) provide us with information for monitoring 
and public reporting purposes. Form Number: CMS-10500 (OMB control 
number: 0938-1240); Frequency: Once; Affected Public: Individuals and 
households; Number of Respondents: 633,304; Total Annual Responses: 
633,304; Total Annual Hours: 153,592. (For policy questions regarding 
this collection contact Memuna Ifedirah at 410-786-6849).
    7. Type of Information Collection Request: New collection (Request 
for new OMB control number); Title of Information Collection: Medicare 
Enrollment Application for Physician and Non-Physician Practitioners; 
Use: The application is used by Medicare contractors to collect data to 
ensure that the applicant has the necessary credentials to provide the 
health care services for which they intend to bill Medicare, including 
information that allows the Medicare contractor to correctly price, 
process and pay the applicant's claims. This application collects 
information to ensure that only legitimate physicians, non-physician 
practitioners, and other eligible professionals are enrolled in the 
Medicare program. It is meant to be the first line defense to protect 
our beneficiaries from illegitimate providers and to protect the 
Medicare Trust Fund against fraud. It also gathers information that 
allows Medicare contractors to ensure that the provider/supplier is not 
sanctioned from the Medicare and/or Medicaid program(s), or debarred, 
suspended or excluded from any other Federal agency or program. Form 
Number: CMS-855i (OMB control number: 0938-NEW); Frequency: On 
Occasion; Affected Public: State, Local, or Tribal Governments, Private 
Sector (not-for-profit institutions); Number of Respondents: 513,872; 
Total Annual Responses: 1,370,078; Total Annual Hours: 1,000,167. For 
policy questions regarding this collection contact Kimberly McPhillips 
at (410)-786-5374.

    Dated: July 10, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-15038 Filed 7-12-18; 8:45 am]
 BILLING CODE 4120-01-P