83 FR 25009 - Proposed Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 105 (May 31, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 105 (May 31, 2018)
| Page Range | 25009-25012 | |
| FR Document | 2018-11628 |
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)] [Notices] [Pages 25009-25012] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11628] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2018-0054] Proposed Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) requests comments on a plan to (1) revise the definition and characterization of Assisted Reproductive Technology (ART) success rates and (2) introduce clinic validation footnotes for the annual ART Fertility Clinic Success Rates Report. The footnotes will identify clinics that are selected by CDC to participate in the validation process of the National ART Surveillance System (NASS) data and that: (1) Do participate, (2) do participate and have major data discrepancies identified through this process, and/or U3) decline to participate in the data validation process. CDC requests comments on this plan in order to continue to ensure that the public has access to accurate and transparent data pursuant to the Fertility Clinic Success Rate and Certification Act of 1992. DATES: Written comments must be received on or before July 2, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0054 by any of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Mail: Sara Crawford, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS F-74, Atlanta, Georgia 30341. Phone: (770) 488-6370. Email: [email protected]. Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to http://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Sara Crawford, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS F-74, Atlanta, Georgia 30341. Phone: (770) 488- 6370. Email: [email protected]. SUPPLEMENTARY INFORMATION: I. Success Rates A. Background Section 2(a) of Public Law 102-493 (42 U.S.C. 263a-1(a)), the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), requires that each assisted reproductive technology (ART) program report annually to the Secretary of the Department of Health and Human Services through the Centers for Disease Control and Prevention (CDC) pregnancy success rates achieved through assisted reproductive technology. The FCSRCA also requires the CDC to annually publish and distribute to the public reported pregnancy success rates. According to the FCSRCA, the definitions of pregnancy success rates should be developed in consultation with appropriate consumer and professional organizations, should take into account the effect on success rates of age, diagnosis, and other significant factors, and should include the live birth rate per attempted ovarian stimulation procedure and the live birth rate per successful oocyte retrieval. Specifics about the reporting process and requirements are described in [[Page 25010]] ``Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs'' (80 FR 51811). Specifics about the definition and characterization of ART success rates were last described in ``Reporting of Pregnancy Success Rates from Assisted Reproductive Technology Programs'' (69 FR 5548). Success rates for fresh, nondonor cycles were defined as: (1) The rate of pregnancy after completion of ART according to the number of all ovarian stimulation or monitoring procedures; (2) the rate of live birth after completion of ART according to the number of all ovarian stimulation or monitoring procedures, the number of oocyte retrieval processes, and the number of embryo (or zygote or oocyte) transfer procedures; (3) the rate of singleton live birth after completion of ART according to the number of all ovarian stimulation or monitoring procedures and the number of embryo (or zygote or oocyte) transfer procedures. Success rates for cycles using thawed embryos and cycles using donor oocytes or embryos were defined as: (4) The rate of live birth after completion of ART according to the number of embryo (or zygote or oocyte) transfer procedures; (5) the rate of singleton live birth after completion of ART according to the number of embryo (or zygote or oocyte) transfer procedures. Effective for reporting year 2017, CDC is proposing substantial changes to the definition and characterization of ART success rates due to changes in clinical practice and more variation in treatment options, including improvements in cryopreservation resulting in more segmentation of typical treatment cycles. The field of ART is moving toward the calculation and reporting of cumulative success rates where data collection systems can collect successes over all embryo transfers from a single oocyte retrieval or across several oocyte retrievals and embryo transfers. After consultation with consumer and professional organizations with expertise in ART, CDC will begin cumulative ART success rates reporting in reporting year 2017. The ART success rates described in this Federal Register notice shall replace those previously described in 2004. B. ART Procedures Among Patients Using Their Own Oocytes ART success rates for ART procedures among all patients using their own eggs will be defined as: 1. The rate of live birth or singleton live birth resulting from the transfer of oocytes retrieved from the patient in the year prior to the reporting year or from the transfer of embryos created from oocytes retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, transfer procedures must have started within 12 months of the start of the retrieval procedure. Oocytes must have been retrieved in the year prior to the reporting year in order to allow for a full year to perform transfers of the retrieved oocytes (either in the prior reporting year or in the current reporting year). The live birth rate and singleton live birth rate will be presented according to the number of: a. All ovarian stimulation or monitoring procedures started from the year prior to the reporting year with the intent to retrieve oocytes from the patient. b. All ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient in which at least one oocyte was retrieved. c. All transfer procedures of at least one oocyte retrieved from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure. 2. The number of ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient presented according to the number of: a. Live births resulting from all transfers of at least one oocyte retrieved from the patient in the year prior to the reporting year, or transfers of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure. Other rates for ART procedures among all patients using their own eggs may be defined as-- 3. The rate of cancellation, implantation, pregnancy, live birth, singleton live birth, multiple live birth, twin live birth, triplet or higher order live birth, preterm live birth, low birthweight live birth or term, normal birthweight and singleton live birth resulting from the transfer of oocytes retrieved from the patient in the year prior to the reporting year or the transfer of embryos created from oocytes retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, transfer procedures must have started within 12 months of the start of the retrieval procedure. These other rates may be presented according to the number of: a. All ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient. b. All ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient in which at least one oocyte was retrieved. c. All transfer procedures of at least one oocyte retrieved from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure. d. All first, second, third, or more transfer procedures after retrieval of at least one oocyte from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure. Rates for ART procedures among new ART patients (i.e., patients that have never had a prior ART cycle ever) using their own oocytes will be defined as-- 4. The rate of live birth resulting from the transfer of oocytes or embryos from all first intended oocyte retrievals presented according to the number of: a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. For the purpose of this definition, the retrieval procedure must have started in the year prior to the reporting year. 5. The rate of live birth resulting from the transfer of oocytes or embryos from all first or second intended oocyte retrievals presented according to the number of: a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. For the purpose of this definition, the retrieval procedure must have started in the year prior to the reporting year. 6. The rate of live birth resulting from the transfer of oocytes or embryos from all intended oocyte retrievals presented according to the number of: [[Page 25011]] a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. For the purpose of this definition, the retrieval procedure must have started in the year prior to the reporting year. 7. The number of ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient presented according to the number of: a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. 8. The number of transfer procedures of at least one oocyte retrieved from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year presented according to the number of: a. Ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure. Also, ART patients must have reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. C. ART Procedures Among Patients Using Oocytes or Embryos From a Donor Success rates for ART procedures among patients using oocytes or embryos from a donor will be defined as-- 9. The rate of live birth or singleton live birth presented according to the number of: a. Transfer procedures of at least one donor egg, embryo created from a donor egg, or donated embryo started in the current reporting year. Other rates for ART procedures among patients using oocytes or embryos from a donor may also be defined as-- 10. The rate of cancellation, implantation, pregnancy, live birth, singleton live birth, multiple live birth, twin live birth, triplet or higher order live birth, preterm live birth, low birthweight live birth, or term, normal birthweight and singleton live birth presented according to the number of: a. ART procedures to prepare a patient (recipient) for the transfer of at least one donor egg, embryo created from a donor egg, or donated embryo, started in the current reporting year. b. Transfer procedures of at least one donor egg, embryo created from a donor egg, or donated embryo started in the current reporting year. D. ART Procedures Among All Patients and All Cycle Types ART reporting may also include: 11. The number, average number or percentage of ART procedures or ART patients with certain characteristics, such as: a. Patient characteristics (e.g. patient age or reason for ART). b. ART procedure characteristics (e.g. type of treatment (fertility preservation, short term banking, in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer), stimulation protocol, source of the oocytes or embryos (patient or donor), the state of the oocytes or embryos (fresh or frozen), the intent of the procedure, the use of prenatal genetic diagnosis or screening, the use of intracytoplasmic sperm injection, the use of assisted hatching, the use of a gestational carrier, the stage of the embryo at transfer, or the number of embryos transferred). All ART patient and procedure characteristics, ART success rates, and other rates for patients using their own oocytes as well as for patients using oocytes or embryos from a donor may be stratified by factors thought to influence the outcome of an ART procedure. 12. Factors for stratification may include: a. Characteristics of the ART patient such as patient age or reason for ART. b. Characteristics of the ART procedure such as type of treatment (fertility preservation, short term banking, in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer), stimulation protocol, the source of the oocytes or embryos (patient or donor), the state of the oocytes or embryos (fresh or frozen), the intent of the procedure, the use of prenatal genetic diagnosis or screening, the use of intracytoplasmic sperm injection, the use of assisted hatching, the use of a gestational carrier, the stage of the embryo at transfer, or the number of embryos transferred. Section II. Validation A description of external validation of clinic data conducted annually as a part of the ART surveillance program is described in ``Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs'' (80 FR 51811). This notice explains, ``If major data discrepancies are identified during data validation (e.g., lack of supporting information for pregnancy outcomes, underreporting cycles, etc.), CDC may re-select these ART programs for data validation during the following reporting year(s) to assess corrections of identified data errors.'' Additionally, effective as of the 2019 reporting year, CDC will include a footnote in the annual ART Fertility Clinic Success Rates Report to identify clinics that are selected by CDC to participate in the validation process of the NASS data and that: 1) do participate, 2) do participate and have major data discrepancies identified through this process, and/or 3) decline to participate in the data validation process. CDC will include this footnote pending the availability of the necessary resources. This footnote is a new addition to the annual ART Fertility Clinic Success Rates Report. Pursuant to the Fertility Clinic Success Rate and Certification Act of 1992, the CDC is mandated to publish the clinic-specific success rates reported by each clinic. These footnotes will help to alert the public if there is evidence that the reported success rates may be of questionable quality, thereby increasing the transparency of the data reporting process. If a clinic is selected to participate in the NASS data validation process and does participate, the following footnote will be added: This clinic was visited for validation of (insert: reporting year) data. See Appendix A for additional information. If a clinic is selected to participate in the NASS data validation process, does participate, and major data discrepancies are identified for either the number of reported ART cycles or the ART pregnancy outcome, the following footnote will be added: This clinic was visited for validation of (insert: reporting year) data. Major data discrepancies were identified for (insert: ``the number of reported cycles'' or ``the pregnancy outcomes'' or ``the number of reported cycles and the pregnancy outcomes''). See Appendix A for additional information. If a clinic is selected to participate in the NASS data validation process and declines to participate, the following footnote will be added: This clinic was selected for validation of (insert: reporting year) data, but declined to participate. See Appendix A for additional information. Appendix A of the ART Fertility Clinic Success Rates Report contains information about the validation of NASS data, including methods used for clinic selection, and displays aggregate validation results. Aggregate validation results include national discrepancy [[Page 25012]] rates; clinic-specific discrepancy rates are not reported. Any footnote added to a clinic's success rates page in the ART Fertility Clinic Success Rates Report will appear only for the reporting year that the clinic was selected for validation; it will be removed the following reporting year. Dated: May 24, 2018. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2018-11628 Filed 5-30-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices 25009
methods). Although it is possible that health departments across the US. The in the jurisdictional exercises through
notifications or responses may be purpose of these tests would be to one or more of the following
intercepted or seen by someone who is evaluate the acceptability of the mechanisms; in-person focus groups,
not part of the team collecting the data, program with members of the potential online survey, online discussion groups.
it is not likely that this will have a major target audience following an anthrax
CDC is requesting approval for this
impact on the respondents’ privacy. incident and to ensure proper
CDC and contractors will also conduct new generic clearance for data
functionality of the StopAnthraxTM
periodic usability and user experience protocols within the system. These tests collection for a period of three years.
tests of StopAnthraxTM in conjunction will occur no more than twice a year The total burden hours for respondents
with points of dispensing (PODs) and feedback on the program will be is 38,000 hours. There are no costs to
exercises conducted by state and local collected from volunteers participating respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Adult MCM recipient ......................... 60-day StopAnthraxTM program ....... 20,000 1 90/60 30,000
POD volunteer participating in user Shortened (10-day) StopAnthrax 4,000 1 30/60 2,000
experience/usability testing of protocol.
shortened StopAnthraxTM protocol.
POD volunteer participating in user Online Survey ................................... 2,000 1 1 2,000
experience/usability testing.
POD volunteer participating in user Discussion/focus groups .................. 2,000 1 2 4,000
experience/usability testing.
Total ........................................... ........................................................... ........................ ........................ ........................ 38,000
Jeffrey M. Zirger, Surveillance System (NASS) data and Health, National Center for Chronic
Acting Chief, Information Collection Review that: (1) Do participate, (2) do Disease Prevention and Health
Office, Office of Scientific Integrity, Office participate and have major data Promotion, Centers for Disease Control
of the Associate Director for Science, Office discrepancies identified through this and Prevention, 4770 Buford Highway
of the Director, Centers for Disease Control process, and/or U3) decline to NE, MS F–74, Atlanta, Georgia 30341.
and Prevention. participate in the data validation Phone: (770) 488–6370. Email: artinfo@
[FR Doc. 2018–11648 Filed 5–30–18; 8:45 am] process. CDC requests comments on this cdc.gov.
BILLING CODE 4163–18–P plan in order to continue to ensure that SUPPLEMENTARY INFORMATION:
the public has access to accurate and
transparent data pursuant to the I. Success Rates
DEPARTMENT OF HEALTH AND Fertility Clinic Success Rate and A. Background
HUMAN SERVICES Certification Act of 1992. Section 2(a) of Public Law 102–493
Centers for Disease Control and DATES: Written comments must be (42 U.S.C. 263a–1(a)), the Fertility
Prevention received on or before July 2, 2018. Clinic Success Rate and Certification
ADDRESSES: You may submit comments, Act of 1992 (FCSRCA), requires that
[Docket No. CDC–2018–0054] identified by Docket No. CDC–2018– each assisted reproductive technology
Proposed Assisted Reproductive 0054 by any of the following methods: (ART) program report annually to the
• Federal eRulemaking Portal: http:// Secretary of the Department of Health
Technology (ART) Success Rates
www.regulations.gov. Follow the and Human Services through the
Reporting and Data Validation
instructions for submitting comments. Centers for Disease Control and
Procedures • Mail: Sara Crawford, Division of Prevention (CDC) pregnancy success
AGENCY: Centers for Disease Control and Reproductive Health, National Center rates achieved through assisted
Prevention (CDC), Department of Health for Chronic Disease Prevention and reproductive technology. The FCSRCA
and Human Services (HHS). Health Promotion, Centers for Disease also requires the CDC to annually
ACTION: Notice with comment period. Control and Prevention, 4770 Buford publish and distribute to the public
Highway NE, MS F–74, Atlanta, Georgia reported pregnancy success rates.
SUMMARY: The Centers for Disease 30341. Phone: (770) 488–6370. Email: According to the FCSRCA, the
Control and Prevention (CDC) in the artinfo@cdc.gov. definitions of pregnancy success rates
Department of Health and Human Instructions: All submissions received should be developed in consultation
Services (HHS) requests comments on a must include the agency name and with appropriate consumer and
plan to (1) revise the definition and Docket Number. All relevant comments professional organizations, should take
characterization of Assisted received will be posted without change into account the effect on success rates
amozie on DSK3GDR082PROD with NOTICES1
Reproductive Technology (ART) success to http://regulations.gov, including any of age, diagnosis, and other significant
rates and (2) introduce clinic validation personal information provided. For factors, and should include the live
footnotes for the annual ART Fertility access to the docket to read background birth rate per attempted ovarian
Clinic Success Rates Report. The documents or comments received, go to stimulation procedure and the live birth
footnotes will identify clinics that are http://www.regulations.gov. rate per successful oocyte retrieval.
selected by CDC to participate in the FOR FURTHER INFORMATION CONTACT: Sara Specifics about the reporting process
validation process of the National ART Crawford, Division of Reproductive and requirements are described in
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![25012 Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
rates; clinic-specific discrepancy rates www.regulations.gov. Follow the Information Collection
are not reported. Any footnote added to instructions for ‘‘Comment or 1. Type of Information Collection
a clinic’s success rates page in the ART Submission’’ or ‘‘More Search Options’’ Request: Revision of a currently
Fertility Clinic Success Rates Report to find the information collection approved collection; Title of
will appear only for the reporting year document(s) that are accepting Information Collection: Pre-Claim
that the clinic was selected for comments. Review Demonstration for Home Health
validation; it will be removed the 2. By regular mail. You may mail Services; Use: Section 402(a)(1)(J) of the
following reporting year. written comments to the following Social Security Amendments of 1967
address: CMS, Office of Strategic (42 U.S.C. 1395b–1(a)(1)(J)) authorizes
Dated: May 24, 2018.
Operations and Regulatory Affairs, the Secretary to ‘‘develop or
Sandra Cashman,
Division of Regulations Development, demonstrate improved methods for the
Executive Secretary, Centers for Disease Attention: Document Identifier/OMB
Control and Prevention. investigation and prosecution of fraud
Control Number ll, Room C4–26–05,
[FR Doc. 2018–11628 Filed 5–30–18; 8:45 am] in the provision of care or services
7500 Security Boulevard, Baltimore,
under the health programs established
BILLING CODE 4163–18–P Maryland 21244–1850.
To obtain copies of a supporting by the Social Security Act (the Act).’’
statement and any related forms for the Pursuant to this authority, the CMS
DEPARTMENT OF HEALTH AND proposed collection(s) summarized in seeks to develop and implement a
HUMAN SERVICES this notice, you may make your request Medicare demonstration project, which
using one of following: CMS believes will help assist in
Centers for Medicare & Medicaid 1. Access CMS’ website address at developing improved procedures for the
Services https://www.cms.gov/Regulations-and- identification, investigation, and
[Document Identifiers CMS–10599] Guidance/Legislation/ prosecution of Medicare fraud occurring
PaperworkReductionActof1995/PRA- among Home Health Agencies (HHA)
Agency Information Collection Listing.html. providing services to Medicare
Activities: Proposed Collection; 2. Email your request, including your beneficiaries.
Comment Request address, phone number, OMB number, This revised demonstration would
and CMS document identifier, to help assist in developing improved
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov. procedures for the identification,
Medicaid Services, HHS. 3. Call the Reports Clearance Office at investigation, and prosecution of
ACTION: Notice. (410) 786–1326. potential Medicare fraud. The
FOR FURTHER INFORMATION CONTACT: demonstration would help make sure
SUMMARY: The Centers for Medicare & that payments for home health services
Medicaid Services (CMS) is announcing William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
are appropriate through either pre-claim
an opportunity for the public to or postpayment review, thereby working
comment on CMS’ intention to collect Contents towards the prevention and
information from the public. Under the identification of potential fraud, waste,
This notice sets out a summary of the
Paperwork Reduction Act of 1995 (the and abuse; the protection of Medicare
use and burden associated with the
PRA), federal agencies are required to Trust Funds from improper payments;
following information collections. More
publish notice in the Federal Register and the reduction of Medicare appeals.
detailed information can be found in
concerning each proposed collection of CMS proposes initially implementing
each collection’s supporting statement
information (including each proposed the demonstration in Illinois, Ohio,
and associated materials (see
extension or reinstatement of an existing North Carolina, Florida, and Texas with
ADDRESSES).
collection of information) and to allow the option to expand to other states in
60 days for public comment on the CMS–10599 Pre-Claim Review the Palmetto/JM jurisdiction. Under this
proposed action. Interested persons are Demonstration for Home Health demonstration, CMS proposes to offer
invited to send comments regarding our Services choices for providers to demonstrate
burden estimates or any other aspect of Under the PRA (44 U.S.C. 3501– their compliance with CMS’ home
this collection of information, including 3520), federal agencies must obtain health policies. Providers in the
the necessity and utility of the proposed approval from the Office of Management demonstration states may participate in
information collection for the proper and Budget (OMB) for each collection of either 100 percent pre-claim review or
performance of the agency’s functions, information they conduct or sponsor. 100 percent postpayment review. These
the accuracy of the estimated burden, The term ‘‘collection of information’’ is providers will continue to be subject to
ways to enhance the quality, utility, and defined in 44 U.S.C. 3502(3) and 5 CFR a review method until the HHA reaches
clarity of the information to be 1320.3(c) and includes agency requests the target affirmation or claim approval
collected, and the use of automated or requirements that members of the rate. Once a HHA reaches the target pre-
collection techniques or other forms of public submit reports, keep records, or claim review affirmation or post-
information technology to minimize the provide information to a third party. payment review claim approval rate, it
information collection burden. Section 3506(c)(2)(A) of the PRA may choose to be relieved from claim
DATES: Comments must be received by requires federal agencies to publish a reviews, except for a spot check of their
July 30, 2018. 60-day notice in the Federal Register claims to ensure continued compliance.
ADDRESSES: When commenting, please concerning each proposed collection of Providers who do not wish to
amozie on DSK3GDR082PROD with NOTICES1
reference the document identifier or information, including each proposed participate in either 100 percent pre-
OMB control number. To be assured extension or reinstatement of an existing claim or postpayment reviews have the
consideration, comments and collection of information, before option to furnish home health services
recommendations must be submitted in submitting the collection to OMB for and submit the associated claim for
any one of the following ways: approval. To comply with this payment without undergoing such
1. Electronically. You may send your requirement, CMS is publishing this reviews; however, they will receive a 25
comments electronically to http:// notice. percent payment reduction on all claims
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Document Created: 2018-05-31 00:48:18
Document Modified: 2018-05-31 00:48:18
| 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 with comment period. | |
| Dates | Written comments must be received on or before July 2, 2018. | |
| Contact | Sara Crawford, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS F-74, Atlanta, Georgia 30341. Phone: (770) 488- 6370. Email: [email protected] | |
| FR Citation | 83 FR 25009 |
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