[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11037-11040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03235]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-R-10, CMS-10116, CMS-R-26, CMS-10069, CMS-
10629, CMS-10266, CMS-8003, CMS-4040, CMS-10156, CMS-10170, CMS-10198, 
CMS-10227, CMS-10344, CMS-416, CMS-R-244, and CMS-10219]


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 20, 2017.

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

[[Page 11038]]

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' Web site 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: Extension of a 
previously approved collection; Title of Information Collection: 
Advance Directives (Medicare and Medicaid) and Supporting Regulations; 
Use: The advance directives requirement was enacted because Congress 
wanted individuals to know that they have a right to make health care 
decisions and to refuse treatment even when they are unable to 
communicate. Steps have been taken at both the Federal and State level, 
to afford greater opportunity for the individual to participate in 
decisions made concerning the medical treatment to be received by an 
adult patient in the event that the patient is unable to communicate to 
others, a preference about medical treatment. The individual may make 
his preference known through the use of an advance directive, which is 
a written instruction prepared in advance, such as a living will or 
durable power of attorney. This information is documented in a 
prominent part of the individual's medical record. Advance directives 
as described in the Patient Self-Determination Act have increased the 
individual's control over decisions concerning medical treatment. 
Sections 4206 of the Omnibus Budget Reconciliation Act of 1990 defined 
an advance directive as a written instruction recognized under State 
law relating to the provision of health care when an individual is 
incapacitated (those persons unable to communicate their wishes 
regarding medical treatment).
    All states have enacted legislation defining a patient's right to 
make decisions regarding medical care, including the right to accept or 
refuse medical or surgical treatment and the right to formulate advance 
directives. Participating hospitals, skilled nursing facilities, 
nursing facilities, home health agencies, providers of home health 
care, hospices, religious nonmedical health care institutions, and 
prepaid or eligible organizations (including Health Care Prepayment 
Plans (HCPPs) and Medicare Advantage Organizations (MAOs) such as 
Coordinated Care Plans, Demonstration Projects, Chronic Care 
Demonstration Projects, Program of All Inclusive Care for the Elderly, 
Private Fee for Service, and Medical Savings Accounts must provide 
written information, at explicit time frames, to all adult individuals 
about: (a) The right to accept or refuse medical or surgical 
treatments; (b) the right to formulate an advance directive; (c) a 
description of applicable State law (provided by the State); and (d) 
the provider's or organization's policies and procedures for 
implementing an advance directive. Form Number: CMS-R-10 (OMB control 
number: 0938-0610); Frequency: Yearly; Affected Public: Business or 
other for-profits; Number of Respondents: 39,479; Total Annual 
Responses: 39,479; Total Annual Hours: 2,836,441. (For policy questions 
regarding this collection contact Jeannine Cramer at 410-786-5664.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Conditions for 
Payment of Power Mobility Devices, including Power Wheelchairs and 
Power-Operated Vehicles; Use: We are renewing our request for approval 
for the collection requirements associated with the final rule, CMS-
3017-F (71 FR 17021), which published on April 5, 2006, and required a 
face-to-face examination of the beneficiary by the physician or 
treating practitioner, a written prescription, and receipt of pertinent 
parts of the medical record by the supplier within 45 days after the 
face-to-face examination that the durable medical equipment (DME) 
suppliers maintain in their records and make available to CMS and its 
agents upon request. Form Number: CMS-10116 (OMB control number: 0938-
0971); Frequency: Yearly; Affected Public: Business or other for-
profits; Number of Respondents: 46,000; Number of Responses: 72,500; 
Total Annual Hours: 14,434. (For policy questions regarding this 
collection contact Stuart Caplan at 410-786-8564)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Clinical 
Laboratory Improvement Amendments (CLIA) Regulations; Use: The 
information is necessary to determine an entity's compliance with the 
Congressionally-mandated program with respect to the regulation of 
laboratory testing (CLIA). In addition, laboratories participating in 
the Medicare program must comply with CLIA requirements as required by 
section 6141 of OBRA 89. Medicaid, under the authority of section 
1902(a)(9)(C) of the Social Security Act, pays for services furnished 
only by laboratories that meet Medicare (CLIA) requirements. Form 
Number: CMS-R-26 (OMB Control Number: 0938-0612); Frequency: Monthly, 
occasionally; Affected Public: Business or other for-profits and Not-
for-profit institutions, State, Local or Tribal Governments, and the 
Federal government; Number of Respondents: 70,861; Total Annual 
Responses: 1,979,300; Total Annual Hours: 14,975,785. (For policy 
questions regarding this collection contact Raelene Perfetto at 410-
786-6876).
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare/Medicaid 
Demonstration/Model Application; Use: The application is used for 
solicitation of proposals that are either congressionally mandated or 
Administration high priority demonstration initiatives which would be 
used to strengthen and modernize the Medicare and/or Medicaid programs. 
The standardized proposal format is not controversial and will reduce 
burden on applicants and reviewers. Responses are strictly voluntary. 
The standard format will enable CMS to select proposals that meet CMS 
objectives and show the best potential for success. Form Number: CMS-
10069 (OMB control number: 0938-0880); Frequency: Once; Affected

[[Page 11039]]

Public: Business or other for-profits and Not-for-profit institutions; 
Number of Respondents: 75; Total Annual Responses: 75; Total Annual 
Hours: 6,000. (For policy questions regarding this collection contact 
John Amoh at 410-786-4910).
    5. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Waiver 
Application for Providers and Suppliers Subject to an Enrollment 
Moratorium; Use: This demonstration, in conjunction with an expansion 
of the existing provider enrollment moratoria, will allow CMS to 
mitigate known vulnerabilities within the existing moratoria and will 
lead to increased investigations of fraud. Section 402(a)(l)(J) of the 
Social Security Amendments of 1967 (42 U.S.C. 1395b-l(a)(l)(J)) permits 
the Secretary to ``develop or demonstrate improved methods for the 
investigation and prosecution of fraud in the provision of care or 
services under the health programs established by the Social Security 
Act.'' In addition to the development and demonstration of improved 
methods for investigations, CMS will utilize this demonstration to 
address beneficiary access to care issues. CMS received one comment 
during the 60-day comment period (81 FR 75408). Form Number: CMS-10629 
(OMB control number: 0938-1313); Frequency: Occasionally; Affected 
Public: Business or other for-profit, Not-for-profit institutions; 
Number of Respondents: 800; Total Annual Responses: 800; Total Annual 
Hours: 4,800. (For policy questions regarding this information 
collection contact Kim Jung at 410-786-9370).
    6. Type of Information Collection Request: Extension of a 
previously approved collection; Title of Information Collection: 
Conditions of Participation: Requirements for Approval and Reapproval 
of Transplant Centers to Perform Organ Transplants; Use: The Conditions 
of Participation and accompanying requirements specified in the 
regulations are used by our surveyors as a basis for determining 
whether a transplant center qualifies for approval or re-approval under 
Medicare. We, along with the healthcare industry, believe that the 
availability to the facility of the type of records and general content 
of records is standard medical practice and is necessary in order to 
ensure the well-being and safety of patients and professional treatment 
accountability. Form Number: CMS-10266 (OMB Control Number: 0938-1069); 
Frequency: Yearly; Affected Public: Business or other for-profits and 
Not-for-profit institutions; Number of Respondents: 165; Total Annual 
Responses: 425; Total Annual Hours: 2,593. (For policy questions 
regarding this collection contact Diane Corning at 410-786-8486.)
    7. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: 1915(c) Home and Community Based Services (HCBS) Waiver; 
Use: We will use the web-based application to review and adjudicate 
individual waiver actions. The web-based application will also be used 
by states to submit and revise their waiver requests. Form Number: CMS-
8003 (OMB control number 0938-0449); Frequency: Yearly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 47; 
Total Annual Responses: 71; Total Annual Hours: 6,005. (For policy 
questions regarding this collection contact Kathy Poisal at 410-786-
5940.)
    8. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Request for 
Enrollment in Supplementary Medical Insurance; Use: Form CMS-4040 is 
used to establish entitlement to and enrollment in Medicare Part B for 
beneficiaries who file for Part B only. The collected information is 
used to determine entitlement for individuals who meet the requirements 
in section 1836(2) of the Social Security Act as well as the 
entitlement of the applicant (or their spouses) to an annuity paid by 
OPM for premium deduction purposes. Form Number: CMS-4040 (OMB control 
number: 0938-0245); Frequency: Once; Affected Public: Individuals or 
households; Number of Respondents: 10,000; Total Annual Responses: 
10,000; Total Annual Hours: 2,500. (For policy questions regarding this 
collection contact Carla Patterson at 410-786-8911.)
    9. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Retiree Drug 
Subsidy (RDS) Application and Instructions; Use: Plan sponsors (e.g., 
employers, unions) who offer prescription drug coverage to their 
qualified covered retirees are eligible to receive a 28 percent tax-
free subsidy for allowable drug costs. To qualify, plan sponsors must 
submit a complete application with a list of retirees for whom it 
intends to collect the subsidy. Once we review and analyze the 
information on the application and the retiree list, notification will 
be sent to the plan sponsor about its eligibility to participate in the 
RDS program. Form Number: CMS-10156 (OMB control number: 0938-0957); 
Frequency: Yearly and monthly; Affected Public: Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 2,482; 
Total Annual Responses: 2,482; Total Annual Hours: 158,848. (For policy 
questions regarding this collection contact Ivan Iveljic at 410-786-
3312.)
    10. Type of Information Collection Request: Extension of a 
currently approved collection; Title of Information Collection: Retiree 
Drug Subsidy (RDS) Payment Request and Instructions; Use: Plan sponsors 
(e.g., employers, unions) who offer prescription drug coverage meeting 
specified criteria to their qualified covered retirees are eligible to 
receive a 28 percent tax-free subsidy for allowable drug costs. Plan 
sponsors must submit required prescription drug cost data and other 
information in order to receive the subsidy. Plan sponsors may elect to 
submit RDS payment requests on a monthly, quarterly, interim annual, or 
annual basis; once selected, the payment frequency may not be changed 
during the plan year. Form Number: CMS-10170 (OMB control number: 0938-
0977); Frequency: Occasionally; Affected Public: Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 2,482; 
Total Annual Responses: 2,482; Total Annual Hours: 374,782. (For policy 
questions regarding this collection contact Ivan Iveljic at 410-786-
3312.)
    11. Type of Information Collection Request: Extension of a 
currently approved collection; Title of Information Collection: 
Creditable Coverage Disclosure to CMS On-Line Form and Instructions; 
Use: Most entities that currently provide prescription drug benefits to 
any Medicare Part D eligible individual must disclose whether their 
prescription drug benefit is creditable (expected to pay at least as 
much, on average, as the standard prescription drug plan under 
Medicare). The disclosure must be provided annually and upon any change 
that affects whether the coverage is creditable prescription drug 
coverage. Form Number: CMS-10198 (OMB control number: 0938-1013); 
Frequency: Yearly and semi-annually; Affected Public: Business or other 
for-profits and Not-for-profit institutions, and State, Local, or 
Tribal Governments; Number of Respondents: 85,635; Total Annual 
Responses: 87,265; Total Annual Hours: 7,272. (For policy questions 
regarding this collection contact Tammie Wall at 410-786-3317.)
    12. Type of Information Collection Request: Extension of a 
currently

[[Page 11040]]

approved collection; Title of Information Collection: PACE State Plan 
Amendment Preprint; Use: If a state elects to offer PACE as an optional 
Medicaid benefit, it must complete a state plan amendment preprint 
packet described as ``Enclosures 3, 4, 5, 6, and 7.'' CMS will review 
the information provided in order to determine if the state has 
properly elected to cover PACE services as a state plan option. In the 
event that the state changes something in the state plan, only the 
affected page must be updated. Form Number: CMS-10227 (OMB control 
number: 0938-1027); Frequency: Once and occasionally; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 7; Total 
Annual Responses: 2; Total Annual Hours: 140. (For policy questions 
regarding this collection contact Angela Cimino at 410-786-2638.)
    13. Type of Information Collection Request: Extension of a 
currently approved collection; Title of Information Collection: 
Elimination of Cost-Sharing for Full Benefit Dual-Eligible Individuals 
Receiving Home and Community-Based Services; Use: This collection 
eliminates Part D cost-sharing for full benefit dual-eligible 
beneficiaries who are receiving home and community based services. In 
this regard, states are required to identify the affected beneficiaries 
in their monthly Medicare Modernization Act Phase Down reports. Form 
Number: CMS-10344 (OMB control number: 0938-1127); Frequency: Monthly; 
Affected Public: Business or other for-profits and Not-for-profit 
institutions; Number of Respondents: 51; Total Annual Responses: 612; 
Total Annual Hours: 612. (For policy questions regarding this 
collection contact Roland Herrera at 410-786-0668.)
    14. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Annual Early and 
Periodic Screening, Diagnostic and Treatment (EPSDT) Participation 
Report; Use: The collected baseline data is used to assess the 
effectiveness of state early and periodic screening, diagnostic and 
treatment (EPSDT) programs in reaching eligible children (by age group 
and basis of Medicaid eligibility) who are provided initial and 
periodic child health screening services, referred for corrective 
treatment, and receiving dental, hearing, and vision services. This 
assessment is coupled with the state's results in attaining the 
participation goals set for the state. The information gathered from 
this report, permits federal and state managers to evaluate the 
effectiveness of the EPSDT law on the basic aspects of the program. 
Form Number: CMS-416 (OMB control number 0938-0354); Frequency: Yearly 
and on occasion; Affected Public: State, Local, or Tribal Governments; 
Number of Respondents: 56; Total Annual Responses: 168; Total Annual 
Hours: 1,624. (For policy questions regarding this collection contact 
Kimberly Perrault at 410-786-2482.)
    15. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Programs for All-
inclusive Care of the Elderly (PACE) and Supporting Regulations in 42 
CFR part 460; Use: This information collection addresses all 
operational components of the PACE program (as defined in 42 CFR part 
460) with the exception of the application process (Sec.  460.12). We 
are removing the application requirements and burden since this CMS-R-
244 package is lengthy and we recognize that it can be somewhat time 
consuming to review. We believe the change will help streamline the 
public and OMB's review of the application as well as the remaining 
requirements and burden under the CMS-R-244 package.
    The application is being moved under a new information collection 
request with a new CMS identification number (CMS-10631). An OMB 
control number specific to the application process is pending. The CMS-
10631 information collection request was submitted to OMB on October 6, 
2016, under ICR Reference No: 201610-0938-001. When approved, the 
control number can be found on www.reginfo.gov/public/.
    Form Number: CMS-R-244 (OMB control number: 0938-0790); Frequency: 
Once and occasionally; Affected Public: Private sector (Business or 
other for-profits and Not-for-profit institutions); Number of 
Respondents: 130; Total Annual Responses: 145,455; Total Annual Hours: 
61,350. (For policy questions regarding this collection contact Debbie 
Van Hoven at 410-786-6625).
    16. Type of Information Collection Request: Extension of a 
currently approved collection; Title of Information Collection: 
Healthcare Effectiveness Data and Information Set (HEDIS[supreg]) Data 
Collection for Medicare Advantage; Use: We use the collected data to: 
monitor Medicare Advantage organization performance, inform audit 
strategies, and inform beneficiary choice through their display in our 
consumer-oriented public compare tools and Web sites. Medicare 
Advantage organizations use the data for quality assessment and as part 
of their quality improvement programs and activities. Quality 
Improvement Organizations and our contractors use HEDIS[supreg] data in 
conjunction with their statutory authority to improve quality of care. 
Consumers use the information to help make informed health care 
choices. In addition, the data is made available to researchers and 
others as public use files at www.cms.hhs.gov. Form Number: CMS-10219 
(OMB control number: 0938-1028); Frequency: Yearly; Affected Public: 
Business or other for-profit and Not-for-profit institutions; Number of 
Respondents: 576; Total Annual Responses: 576; Total Annual Hours: 
184,320. (For policy questions regarding this collection contact Lori 
Teichman at 410-786-6684.)

    Dated: February 14, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-03235 Filed 2-16-17; 8:45 am]
 BILLING CODE 4120-01-P