[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89106-89107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2431-N]


Zika Health Care Services Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the November 9, 2016 publication of a 
funding opportunity providing up to $66.1 million available to support 
prevention activities and treatment services for health conditions 
related to the Zika virus. The funding opportunity solicited single 
source emergency applications for a cooperative agreement aimed at 
supporting prevention activities and treatment services for women 
(including pregnant women), children, and men adversely or potentially 
impacted by the Zika virus. Entities eligible to apply for this funding 
opportunity are states, territories, tribes or tribal organizations, 
with active or local transmission of the Zika virus, as confirmed by 
the Centers for Disease Control and Prevention (CDC). As of October 12, 
2016, the CDC designated American Samoa, Puerto Rico, the U.S. Virgin 
Islands, and Florida as areas with laboratory-confirmed active or local 
Zika virus transmission. As such, this emergency funding opportunity is 
currently available to the territorial and state health departments in 
these areas.

DATES: The project period of performance for the Cooperative Agreement 
will be 36 months from the date of award.

FOR FURTHER INFORMATION CONTACT: Elizabeth Garbarczyk, 410-786-0426.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Zika Response and Preparedness Act (Pub. L. 114-223) provides 
$387,000,000 in funding to prevent, prepare for, and respond to the 
Zika virus. Of the funds appropriated by Public Law 114-223, Congress 
designated $75 million to support states, territories, tribes, or 
tribal organizations with active or local transmission cases of the 
Zika virus, as confirmed by the Centers for Disease Control and 
Prevention (CDC), to reimburse the costs of health care for health 
conditions related to the Zika virus not covered by private insurance. 
No less than $60 million of this funding is for territories with the 
highest rates of Zika transmission.

II. Provisions of the Notice

    In accordance with the Zika Response and Preparedness Act (Pub. L. 
114-223), entities eligible to apply for this funding opportunity 
include states, territories, tribes or tribal organizations with active 
or local transmission of the Zika virus, as confirmed by the Centers 
for Disease Control and Prevention (CDC). As of October 12, 2016, the 
CDC reports that American Samoa, Puerto Rico, the U.S. Virgin Islands, 
and Florida are the only areas with laboratory-confirmed active or 
local transmission of the Zika virus, and therefore, these are the only 
territories and state eligible to receive funding as authorized under 
the legislation. Funding available under the ``Zika Health Care 
Services Program'' may be used to address the following four critical 
components of a comprehensive response to Zika. Applicant needs may 
vary and some applicants may not have unmet needs across each of the 
four areas. If approved by CMS, recipients may use grant funds for 
additional health care services for health conditions related to the 
Zika virus that are not listed in the following section.
1. Increase Access to Contraceptive Services for Women and Men
    Contraceptive services for women and men can reduce the risk of 
unintended pregnancy, as well as sexual transmission of Zika. 
Preventing unintended pregnancy in areas affected by the Zika virus 
outbreak among people who may have been exposed is a primary strategy 
to reduce the number of pregnancies affected by Zika virus. To increase 
access to all FDA-approved contraceptive methods, a territory or state 
must use grant funds to provide client-centered contraceptive 
counseling to educate women (including women who are pregnant and post-
partum) and men on effective contraception methods, increase 
contraceptive supplies in provider offices, increase family planning 
delivery sites, train providers on the full range of contraceptive 
methods and their use, including insertion and removal of long-acting 
reversible contraception (LARC), and to remove a patient's financial 
barriers to use of effective contraception through methods such as cost 
sharing assistance for contraceptive services.
2. Reduce Barriers to Diagnostic Testing, Screening, and Counseling for 
Pregnant Women and Newborns
    Uninsured or underinsured pregnant women may not seek testing and 
medical follow-up if Zika testing does not begin at the initial point 
of prenatal care or if it presents financial hardship. Testing should 
be performed as a part of routine prenatal care. However, additional 
unscheduled prenatal visits may be necessary to complete the testing 
protocol (for example, reflex testing) and to provide pre- and post-
test counseling on the interpretation of results. Funds designated for 
diagnostic testing, screening, and counseling will be used to ensure 
access to diagnostic services to test for Zika infection wherever a 
pregnant woman initially presents for care. This will increase the 
identification of pregnant women infected with Zika, who require 
increased monitoring and prenatal care services, and will lead to early 
diagnosis of infants with special medical needs.
3. Increase Access to Appropriate Specialized Healthcare Services for 
Pregnant Women, Children Born to Mothers With Maternal Zika Virus 
Infection, and Their Families
    Complex clinical and psychosocial needs associated with maternal 
Zika virus infection require access to comprehensive and appropriate 
specialized healthcare, and a coordinated suite of services that serves 
mother, child, and their families. Increased access to prenatal care is 
critical to plan for post-natal care, particularly access to 
ultrasounds which can detect abnormalities in fetal development. In 
addition, high-risk pregnancies and pregnancy loss, can be stressful 
for both the pregnant woman and her family and require psychosocial 
support. Moreover, the infants themselves require enhanced follow-up,

[[Page 89107]]

regardless of whether microcephaly or other conditions are diagnosed 
prenatally or at birth. CDC has published clinical guidance for care of 
pregnant women with evidence of Zika infection and care of infants born 
to mothers who had Zika infection.
4. Improve Provider Capacity and Capability
    We recognize that award recipients will have varying levels of 
infrastructure, provider capacity and capability, and other funding 
sources devoted to addressing Zika. Sufficient provider capacity and 
capability is critical to ensure successful implementation of an 
effective Zika prevention initiative in increasing access to 
contraceptives; reducing barriers to diagnostic testing, screening and 
counseling; and increasing access to appropriate specialized healthcare 
services.
    This funding opportunity has been structured to ensure an effective 
Zika response that addresses the four critical components of a 
comprehensive response to Zika as quickly as possible. Accordingly, the 
single source emergency funding opportunity is solely available to the 
territorial and state health departments in American Samoa, Puerto 
Rico, the U.S. Virgin Islands, and Florida, based on their ability to 
quickly and efficiently expand their existing Zika response efforts and 
to further determine the most effective use and dissemination of funds 
in their respective jurisdictions. The health departments in American 
Samoa, Puerto Rico, U.S. Virgin Islands, and Florida are uniquely 
positioned to meet the goals of the emergency cooperative agreement 
based on their capacity, partnerships, resources, prior experience, and 
ability to begin implementing the project immediately. Immediate 
implementation is critical to successfully addressing this rapidly 
spreading public health threat.
    The budget and project period under the specific funding 
opportunity will be 36 months. The total amount of federal funds 
available in the first round is up to $66,100,000 as follows:
 American Samoa Government Department of Health: $1,100,000
 Puerto Rico Health Department: $60,600,000
 U.S. Virgin Islands Department of Health: $2,100,000
 Florida Department of Health: $2,300,000

A majority of the first round funds are being allocated to Puerto Rico 
based on the magnitude of infections and likely rates of infants born 
to mothers with maternal Zika infection. We expect to issue a second 
round of funds through an additional funding opportunity announcement 
in 2017. The initial funding opportunity seeks to issue funds to 
currently support areas of greatest need, while maintaining additional 
funds to prevent, detect, and respond to future Zika outbreaks.

III. Collection of Information Requirements

    This notice establishes funding opportunities for health 
departments in areas with laboratory-confirmed active or local Zika 
virus transmission. Since we estimate fewer than ten respondents 
(American Samoa, Puerto Rico, the U.S. Virgin Islands, and Florida), 
any information collection requirements and burden are exempt (5 CFR 
1320.3(c)) from the requirements of the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

    Dated: November 30, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-29492 Filed 12-8-16; 8:45 am]
 BILLING CODE 4120-01-P