81 FR 89106 - Zika Health Care Services Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 237 (December 9, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 237 (December 9, 2016)
| Page Range | 89106-89107 | |
| FR Document | 2016-29492 |
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)] [Notices] [Pages 89106-89107] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29492] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![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,
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![Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices 89107
regardless of whether microcephaly or • American Samoa Government Child Support Convention; Federally
other conditions are diagnosed Department of Health: $1,100,000 Approved Forms.
prenatally or at birth. CDC has • Puerto Rico Health Department: OMB No.: 0970–0488.
published clinical guidance for care of $60,600,000
On January 1, 2017, the 2007 Hague
pregnant women with evidence of Zika • U.S. Virgin Islands Department of
infection and care of infants born to Health: $2,100,000 Convention on the International
mothers who had Zika infection. • Florida Department of Health: Recovery of Child Support and Other
$2,300,000 Forms of Family Maintenance will enter
4. Improve Provider Capacity and into force for the United States. In order
Capability A majority of the first round funds are to comply with the Convention, the U.S.
We recognize that award recipients being allocated to Puerto Rico based on must implement the Convention’s case
will have varying levels of the magnitude of infections and likely
processing forms.
infrastructure, provider capacity and rates of infants born to mothers with
capability, and other funding sources maternal Zika infection. We expect to State and Federal law require states to
devoted to addressing Zika. Sufficient issue a second round of funds through use Federally-approved case processing
provider capacity and capability is an additional funding opportunity forms. Section 311(b) of UIFSA 2008,
critical to ensure successful announcement in 2017. The initial which has been enacted by all 50 states,
implementation of an effective Zika funding opportunity seeks to issue the District of Columbia, Guam, Puerto
prevention initiative in increasing funds to currently support areas of Rico and the Virgin Islands, requires
access to contraceptives; reducing greatest need, while maintaining States to use forms mandated by Federal
barriers to diagnostic testing, screening additional funds to prevent, detect, and law. 45 CFR 303.7 also requires child
and counseling; and increasing access to respond to future Zika outbreaks. support programs to use federally-
appropriate specialized healthcare III. Collection of Information approved forms in intergovernmental
services. Requirements IV–D cases unless a country has
This funding opportunity has been provided alternative forms as a part of
structured to ensure an effective Zika This notice establishes funding its chapter in a Caseworker’s Guide to
response that addresses the four critical opportunities for health departments in Processing Cases with Foreign
components of a comprehensive areas with laboratory-confirmed active Reciprocating Countries.
response to Zika as quickly as possible. or local Zika virus transmission. Since
Accordingly, the single source we estimate fewer than ten respondents OCSE received few comments on the
emergency funding opportunity is solely (American Samoa, Puerto Rico, the U.S. burden estimate related to this proposed
available to the territorial and state Virgin Islands, and Florida), any collection during the 60-day comment
health departments in American Samoa, information collection requirements and period, which started September 30,
Puerto Rico, the U.S. Virgin Islands, and burden are exempt (5 CFR 1320.3(c)) 2016 (Federal Register Volume 81,
Florida, based on their ability to quickly from the requirements of the Paperwork Number 190, page 67355). Therefore, we
and efficiently expand their existing Reduction Act of 1995 (44 U.S.C. 3501 have not changed the burden estimate.
Zika response efforts and to further et seq.). Concurrent with this request, OCSE
determine the most effective use and Dated: November 30, 2016. requested an emergency clearance,
dissemination of funds in their pursuant to section 1320.13 of the
Andrew M. Slavitt,
respective jurisdictions. The health implementing rule of the Paperwork
Acting Administrator, Centers for Medicare
departments in American Samoa, Puerto Reduction Act, so that States could
& Medicaid Services.
Rico, U.S. Virgin Islands, and Florida begin using the forms by January 1,
[FR Doc. 2016–29492 Filed 12–8–16; 8:45 am]
are uniquely positioned to meet the 2017, the effective date for the Hague
goals of the emergency cooperative BILLING CODE 4120–01–P
Child Support Convention in the U.S.
agreement based on their capacity,
OMB granted emergency approval,
partnerships, resources, prior
DEPARTMENT OF HEALTH AND which will expire on May 31, 2017.
experience, and ability to begin
implementing the project immediately. HUMAN SERVICES Respondents: State, local, or Tribal
Immediate implementation is critical to agencies administering a child support
Administration for Children and
successfully addressing this rapidly enforcement program under title IV–D
Families
spreading public health threat. of the Social Security Act.
The budget and project period under Submission for OMB Review;
the specific funding opportunity will be Comment Request
36 months. The total amount of federal
funds available in the first round is up Title: Provision of Child Support
to $66,100,000 as follows: Services in IV–D Cases under the Hague
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
mstockstill on DSK3G9T082PROD with NOTICES
Annex I: Transmittal form under Article 12(2) ................................................. 54 46 1 2,484
Annex II: Acknowledgment form under Article 12(3) ....................................... 54 93 .5 2,511
Annex A: Application for Recognition and Enforcement, including restricted
information on the applicant ......................................................................... 54 19 .5 513
Annex A: Abstract of Decision ......................................................................... 54 5 1 270
Annex A: Statement of Enforceability of Decision ........................................... 54 19 0.17 174
Annex A: Statement of Proper Notice ............................................................. 54 5 .5 135
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Document Created: 2018-02-14 09:03:36
Document Modified: 2018-02-14 09:03:36
| 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 | The project period of performance for the Cooperative Agreement will be 36 months from the date of award. | |
| Contact | Elizabeth Garbarczyk, 410-786-0426. | |
| FR Citation | 81 FR 89106 |
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