2024-19392. Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Final Notice

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Department of Health and Human Services

Centers for Disease Control and Prevention

1. [Docket No. CDC-2023-0093]

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services.

ACTION:

General notice.

SUMMARY:

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces revised plans for data collection fields for reporting of pregnancy success rates from assisted reproductive technology (ART) programs and for data validation procedures. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA). ( print page 70190) This notice also responds to public comments received in response to CDC's 2023 request for comment in a Federal Register notice.

DATES:

The requirements for the additional data fields and validation requirements will be implemented for reporting year 2025.

FOR FURTHER INFORMATION CONTACT:

Mithi Sunderam, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S107-2, Atlanta, Georgia 30341. Telephone: [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

On November 28, 2023, CDC published a notice in Federal Register (88 FR 83131) requesting comments on a plan that proposed modifications to (1) data collection fields for reporting of pregnancy success rates from assisted reproductive technology (ART) programs; and (2) data validation procedures. Proposed modifications were the following:

(i) Remove the requirement for clinics to report dosage information for fertility medications including Clomiphene, Letrozole, and long-acting follicle stimulating hormone (FSH).

(ii) Remove the requirement for clinics to report information on research cycle study type.

(iii) Add the requirement for clinics to report date of cryopreservation for fresh embryos.

(iv) Not to pursue targeted validation of clinics and identification of major data discrepancies.

Public Comment Summary and Responses

CDC received seven public comments to the docket. One comment was outside the scope of the docket. Summaries of the six other comments and CDC's responses are provided below.

Proposed Modifications to Data Collection Fields

I. CDC proposal to remove the requirement for clinics to report dosage information for fertility medications, including Clomiphene, Letrozole, other oral medications, and long-acting follicle stimulating hormone: One commenter agreed, two commenters did not comment on this proposed change, and three commenters did not agree to the proposed change. Of those who did not agree, one commenter suggested that CDC should not stop collecting information on long-acting FSH medications as it may be the preferred approach to stimulating egg follicles among egg donors. Another commenter who disagreed suggested that many outcomes and side effects are dosage dependent, and CDC should not remove the requirement to report dosage. A third commenter who also disagreed suggested that follicle stimulating hormone medications have documented risks such as ovarian hyperstimulation and risks to both mother and infants such as ectopic pregnancy and birth defects.

Response: CDC thanks the commenters for providing these comments. CDC notes there may be variation in the type and dosage of medication used to stimulate follicular development, including the use of Clomiphene, Letrozole, and other oral medications. Established treatment protocols and dosage of medication may, on occasion, vary by patient and cycle type and may impact pregnancy success rates.

Based on these comments, CDC will not make proposed changes to remove the requirement for clinics to report dosage information for fertility medications, including Clomiphene, Letrozole, other oral medications described in Federal Register notice (88 FR 83131). However, CDC will stop collecting information on the use and dosage of long-acting FSH medications as they are not approved for use in the United States.

II. CDC proposal to remove the requirement for clinics to report information on research cycle study type: Among the six commenters, one commenter agreed, one commenter did not comment, and four commenters disagreed on this proposed change. Two of the commenters who disagreed stated that the low number of research cycles performed is not a justification for removing this reporting requirement. Two other commenters that disagreed noted the need for more regulation of research cycles as well as follow up of outcomes for patients and infants.

Response: CDC thanks the commenters for providing these comments. CDC proposed to remove the requirement for clinics to report information on the type of research cycle, not the requirement to report information on research cycles in general. CDC will continue to collect information on whether a research cycle was performed as described in the requirements for reporting of pregnancy success rates (80 FR 51811). Additional information on research cycle study type is not necessary.

Therefore, proposed changes to remove the requirement to report research cycle study type as described in Federal Register notice (88 FR 83131) will be made.

III. CDC proposal to add the requirement for clinics to report the date of cryopreservation for fresh embryos: Two commenters agreed, two commenters did not have any comments on this proposed change, one commenter suggested additional information should be provided on the need for this additional data collection, and one commenter had non-substantive responses to this CDC proposal. One commenter who agreed cautioned that the date of embryo cryopreservation could be captured only for the first time that an embryo was thawed but not if the embryo was refrozen again after additional culturing such as in some cases when performing pre-implantation genetic testing (PGT).

Response: CDC thanks the commenters for providing these comments. CDC agrees that under certain circumstances, frozen embryos may be thawed and refrozen for future use after additional days of culturing; however, this is rare. The date of first cryopreservation provides a good proxy of embryo stage even if the embryo was thawed and refrozen for future use. It will allow classification of embryo stage for frozen-embryo transfers and improve the reporting of factors that impact ART success rates.

Based on these comments, CDC will add the date of fresh embryo cryopreservation to the reporting requirements described in Federal Register notice (88 FR 83131).

Proposed Modifications to Data Validation Procedures

CDC proposed not to pursue implementation of a plan to conduct targeted validation of clinics and identification of major data discrepancies as described in the Federal Register published on November 28, 2023, (88 FR 83131) and to maintain validation procedures described in Federal Register notice published on August 26, 2015 (80 FR 51811). One commenter agreed with all changes proposed by CDC but did not have any specific comments regarding the modifications to data validation procedures. Five commenters disagreed with this proposed change stating that the validation process was necessary for data accuracy. Of those who disagreed, one commenter noted that the proposed changes would weaken the validation process and that patients deserved to get accurate data from clinics. One commenter who disagreed noted that validation was necessary to ensure clinics are not inflating success rates. One commenter who disagreed noted ( print page 70191) that data discrepancies could be misleading to the public. One commenter suggested additional fields for targeted validation.

Response: CDC thanks the commenters for providing these comments and notes their feedback and suggestions. CDC strives to provide accurate data and maintains multiple mechanisms to ensure data accuracy: conducting data checks for logical errors and inconsistencies during the data entry stage, verification of data accuracy by clinics' medical directors, and additional data checks for logical errors and internal inconsistencies after submission. If any errors or inconsistencies are identified during these stages, CDC's contractor contacts the clinics and corrects the data.

In addition, CDC currently conducts annual site visits by selecting 5-10% of all reporting clinics and about 70-80 cycles per clinic for data validation as described in Federal Register notice (80 FR 51811). This data validation process involves comparing information for key variables from a patient's medical record with the data submitted to the National ART Surveillance System (NASS), the CDC data reporting system for ART procedures. This information is used to calculate discrepancy rates for these variables. Aggregate findings for validated data fields from all ART programs participating in validation are published annually. In addition, CDC will continue removing a clinic's reported success rates from annual ART reports if the clinic was selected for annual ART data validation but declined to participate, as described in the changes to data validation process published in Federal Register notice (86 FR 20496).

The targeted data validation and major discrepancy analysis were additional mechanisms that CDC was considering identifying any systematic problems that could cause data collection to be inconsistent or incomplete. The commenters' suggestions will be taken under consideration as CDC works toward further refining its data validation process while balancing potential gains in accuracy with additional burden to clinics. The details of any modifications to data validation will be published in a separate Federal Register notice before implementation.

At this time, changes proposed to data validation procedures described in Federal Register notice published on November 28, 2023, (88 FR 83131) will be made. Please see the revised Appendix below for the new requirements.

Appendix—Notice for Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs—Modifications to Data Collection Fields and Data Validation Procedures

The purpose of this notice published August 29, 2024 is to announce revised data collection requirements and data validation procedures. This data collection is approved under Office of Management and Budget Control Number 0920-0556, expiration date: 12/31/2024. Effective for reporting year 2025, CDC is implementing the following changes to its data collection and data validation procedures.

Section III. What To Report

F. Stimulation and Retrieval

Deletion (if Medication Containing FSH Used)

CDC will remove the requirement for clinics to report dosage information for long-acting FSH as described in Federal Register notice 88 FR 83131.

G. Laboratory Information

Deletion (if Cycle was a Research Cycle)

CDC will remove the requirement for clinics to report the research cycle study type. This deletion will apply to all data fields for research study types: Device study, Protocol study, Pharmaceutical study, Laboratory technique, and Other research, as described in Federal Register notice 88 FR 83131.

H. Transfer Information

Addition (if Frozen Embryos Were Transferred)

CDC will add the requirement for clinics to report date of fresh embryo cryopreservation for all frozen embryo transfer procedures as described in Federal Register notice 88 FR 83131.

Data Validation

CDC will not conduct targeted validation of clinics and identification of major discrepancies during data validation, as described in Federal Register notice 83 FR 25353. CDC will continue conducting data validation using stratified random sampling of reporting clinics to assess discrepancy rates for key variables that are generalizable for all reporting clinics and provide feedback to clinics to improve the reporting of data used to report success rates as described in Federal Register notice 80 FR 51811. In addition, CDC will continue removing a clinic's reported success rates from annual ART reports if the clinic was selected for annual ART data validation but declined to participate, as described in Federal Register notice 86 FR 20496.

Noah Aleshire,

Chief Regulatory Officer, Centers for Disease Control and Prevention.