81 FR 89104 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 237 (December 9, 2016)

Page Range		89104-89106
FR Document		2016-29584

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 any of the following subjects: 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.

Federal Register, Volume 81 Issue 237 (Friday, December 9, 2016)

[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89104-89106]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29584]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-10, CMS-10487, CMS-10116, CMS-10219 and 
CMS-10275]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 any of the following subjects: 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 February 7, 2017.

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' 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: 

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-R-10 Advance Directives (Medicare and Medicaid) and Supporting 
Regulations
CMS-10487 Medicaid Emergency Psychiatric Demonstration (MEPD) 
Evaluation
CMS-10116 Conditions for Payment of Power Mobility Devices, including 
Power Wheelchairs and Power-Operated Vehicles
CMS-10219 Healthcare Effectiveness Data and Information Set 
(HEDIS[supreg]) Data Collection for Medicare Advantage
CMS-10275 CAHPS Home Health Care 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 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 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

[[Page 89105]]

(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 
previously approved collection; Title of Information Collection: 
Medicaid Emergency Psychiatric Demonstration (MEPD) Evaluation; Use: 
Since the inception of Medicaid, inpatient care provided to adults ages 
21 to 64 in institutions for mental disease (IMDs) has been excluded 
from federal matching funds. The Emergency Medical Treatment and Active 
Labor Act (EMTALA), however, requires IMDs that participate in Medicare 
to provide treatment for psychiatric emergency medical conditions 
(EMCs), even for Medicaid patients for whose services cannot be 
reimbursed. Section 2707 of the Affordable Care Act (ACA) directs the 
Secretary of Health and Human Services to conduct and evaluate a 
demonstration project to determine the impact of providing payment 
under Medicaid for inpatient services provided by private IMDs to 
individuals with emergency psychiatric conditions between the ages of 
21 and 64. We will use the data to evaluate the Medicaid Emergency 
Psychiatric Demonstration (MEPD) in accordance with the ACA mandates. 
This evaluation in turn will be used by Congress to determine whether 
to continue or expand the demonstration. If the decision is made to 
expand the demonstration, the data collected will help to inform both 
CMS and its stakeholders about possible effects of contextual factors 
and important procedural issues to consider in the expansion, as well 
as the likelihood of various outcomes. Form Number: CMS-10487 (OMB 
control number: 0938-NEW); Frequency: Annually; Affected Public: 
Individuals and households; State, Local and Tribal governments; 
Business and other for-profits and Not-for-profits; Number of 
Respondents: 93; Total Annual Responses: 1,944; Total Annual Hours: 
2,046. (For policy questions regarding this collection contact Vetisha 
McClair at 410-786-4923.)
    3. 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: Private Sector--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.)
    4. 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: Private 
sector--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.)
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: CAHPS Home Health 
Care Survey; Use: The national implementation of the Home Health Care 
Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) 
Survey is designed to collect ongoing data from samples of home health 
care patients who receive skilled services from Medicare-certified home 
health agencies. The data collected from the national implementation of 
the Home Health Care CAHPS Survey will be used for the following 
purposes: (1) To produce comparable data on the patients' perspectives 
of the care they receive from home health agencies, (2) to create 
incentives for agencies to improve the quality of care they provide 
through public reporting of survey results, and (3) to enhance public 
accountability in health care by increasing the transparency of the 
quality of care provided in return for the public investment. Sampling 
and data collection will be conducted on a monthly basis. Survey 
results will be analyzed and reported on a quarterly basis, with 
publicly reported results based on one year's worth of data.
    As part of this information collection request for the national 
implementation of Home Health Care CAHPS, CMS is also requesting 
approval to conduct a randomized mode experiment with a sample of home 
health agencies. The mode experiment compared the responses to the 
survey across the three proposed modes to determine whether adjustments 
are needed to ensure that the data collection mode does not influence 
the survey results. In addition, data from the mode experiment will be 
used to determine which, if any, patient characteristics may affect the 
patients' rating of the care they receive and, if so,

[[Page 89106]]

develop an adjustment model of those data based on those factors. CMS 
worked with RTI, the federal contractor to recruit approximately 100 
home health agencies to participate in the mode experiment. The mode 
experiment included approximately 23,000 home health care patients.
    Form Number: CMS-10275 (OMB control number: 0938-1066); Frequency: 
Quarterly; Affected Public: Individuals and households and the Private 
sector (Business or other for-profit and Not-for-profit institutions); 
Number of Respondents: 2,715,890; Total Annual Responses: 2,715,890; 
Total Annual Hours: 699,440. (For policy questions regarding this 
collection contact Lori Teichman at 410-786-6684.)

    Dated: December 6, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-29584 Filed 12-8-16; 8:45 am]
 BILLING CODE 4120-01-P

89106 Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices

develop an adjustment model of those DATES: The project period of of pregnancies affected by Zika virus. To
data based on those factors. CMS performance for the Cooperative increase access to all FDA-approved
worked with RTI, the federal contractor Agreement will be 36 months from the contraceptive methods, a territory or
to recruit approximately 100 home date of award. state must use grant funds to provide
health agencies to participate in the FOR FURTHER INFORMATION CONTACT: client-centered contraceptive counseling
mode experiment. The mode Elizabeth Garbarczyk, 410–786–0426. to educate women (including women
experiment included approximately SUPPLEMENTARY INFORMATION: who are pregnant and post-partum) and
23,000 home health care patients. men on effective contraception
Form Number: CMS–10275 (OMB I. Background methods, increase contraceptive
control number: 0938–1066); Frequency: The Zika Response and Preparedness supplies in provider offices, increase
Quarterly; Affected Public: Individuals Act (Pub. L. 114–223) provides family planning delivery sites, train
and households and the Private sector $387,000,000 in funding to prevent, providers on the full range of
(Business or other for-profit and Not-for- prepare for, and respond to the Zika contraceptive methods and their use,
profit institutions); Number of virus. Of the funds appropriated by including insertion and removal of long-
Respondents: 2,715,890; Total Annual Public Law 114–223, Congress acting reversible contraception (LARC),
Responses: 2,715,890; Total Annual designated $75 million to support states, and to remove a patient’s financial
Hours: 699,440. (For policy questions territories, tribes, or tribal organizations barriers to use of effective contraception
regarding this collection contact Lori with active or local transmission cases through methods such as cost sharing
Teichman at 410–786–6684.) of the Zika virus, as confirmed by the assistance for contraceptive services.
Dated: December 6, 2016. Centers for Disease Control and 2. Reduce Barriers to Diagnostic Testing,
William N. Parham, III, Prevention (CDC), to reimburse the costs Screening, and Counseling for Pregnant
Director, Paperwork Reduction Staff, Office of health care for health conditions Women and Newborns
of Strategic Operations and Regulatory related to the Zika virus not covered by
Affairs. private insurance. No less than $60 Uninsured or underinsured pregnant
million of this funding is for territories women may not seek testing and
[FR Doc. 2016–29584 Filed 12–8–16; 8:45 am]
with the highest rates of Zika medical follow-up if Zika testing does
BILLING CODE 4120–01–P
transmission. not begin at the initial point of prenatal
care or if it presents financial hardship.
II. Provisions of the Notice Testing should be performed as a part of
DEPARTMENT OF HEALTH AND
HUMAN SERVICES In accordance with the Zika Response routine prenatal care. However,
and Preparedness Act (Pub. L. 114–223), additional unscheduled prenatal visits
Centers for Medicare & Medicaid entities eligible to apply for this funding may be necessary to complete the
Services opportunity include states, territories, testing protocol (for example, reflex
tribes or tribal organizations with active testing) and to provide pre- and post-test
[CMS–2431–N] counseling on the interpretation of
or local transmission of the Zika virus,
as confirmed by the Centers for Disease results. Funds designated for diagnostic
Zika Health Care Services Program
Control and Prevention (CDC). As of testing, screening, and counseling will
AGENCY: Centers for Medicare & October 12, 2016, the CDC reports that be used to ensure access to diagnostic
Medicaid Services (CMS), HHS. American Samoa, Puerto Rico, the U.S. services to test for Zika infection
ACTION: Notice. Virgin Islands, and Florida are the only wherever a pregnant woman initially
areas with laboratory-confirmed active presents for care. This will increase the
SUMMARY: This notice announces the or local transmission of the Zika virus, identification of pregnant women
November 9, 2016 publication of a and therefore, these are the only infected with Zika, who require
funding opportunity providing up to territories and state eligible to receive increased monitoring and prenatal care
$66.1 million available to support funding as authorized under the services, and will lead to early diagnosis
prevention activities and treatment legislation. Funding available under the of infants with special medical needs.
services for health conditions related to ‘‘Zika Health Care Services Program’’
the Zika virus. The funding opportunity 3. Increase Access to Appropriate
may be used to address the following Specialized Healthcare Services for
solicited single source emergency four critical components of a
applications for a cooperative agreement Pregnant Women, Children Born to
comprehensive response to Zika. Mothers With Maternal Zika Virus
aimed at supporting prevention Applicant needs may vary and some
activities and treatment services for Infection, and Their Families
applicants may not have unmet needs
women (including pregnant women), across each of the four areas. If Complex clinical and psychosocial
children, and men adversely or approved by CMS, recipients may use needs associated with maternal Zika
potentially impacted by the Zika virus. grant funds for additional health care virus infection require access to
Entities eligible to apply for this funding services for health conditions related to comprehensive and appropriate
opportunity are states, territories, tribes the Zika virus that are not listed in the specialized healthcare, and a
or tribal organizations, with active or following section. coordinated suite of services that serves
local transmission of the Zika virus, as mother, child, and their families.
confirmed by the Centers for Disease 1. Increase Access to Contraceptive Increased access to prenatal care is
Control and Prevention (CDC). As of Services for Women and Men critical to plan for post-natal care,
October 12, 2016, the CDC designated Contraceptive services for women and particularly access to ultrasounds which
mstockstill on DSK3G9T082PROD with NOTICES

American Samoa, Puerto Rico, the U.S. men can reduce the risk of unintended can detect abnormalities in fetal
Virgin Islands, and Florida as areas with pregnancy, as well as sexual development. In addition, high-risk
laboratory-confirmed active or local transmission of Zika. Preventing pregnancies and pregnancy loss, can be
Zika virus transmission. As such, this unintended pregnancy in areas affected stressful for both the pregnant woman
emergency funding opportunity is by the Zika virus outbreak among and her family and require psychosocial
currently available to the territorial and people who may have been exposed is support. Moreover, the infants
state health departments in these areas. a primary strategy to reduce the number themselves require enhanced follow-up,

VerDate Sep<11>2014 18:13 Dec 08, 2016 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1

Document Created: 2018-02-14 09:03:39
Document Modified: 2018-02-14 09:03:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments must be received by February 7, 2017.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		81 FR 89104

81 FR 89104 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 237 (December 9, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services