106522 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

received (including those under review 

or on hold) until the publication date of 

this Federal Register document for 

transferred products and, if applicable, 

until a final decision on the submission 

is reached. For questions on any 

submissions with CDRH, please contact 

CDRH Product Jurisdiction at 

CDRHProductJurisdiction@fda.hhs.gov. 

For questions on submissions to CBER, 

please contact 

CBERProductJurisdiction@fda.hhs.gov. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31266 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3248] 

Fosun Pharma USA Inc., et al.; 

Withdrawal of Approval of 23 

Abbreviated New Drug Applications; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on July 29, 2024. The 

document announced the withdrawal of 

approval of 23 abbreviated new drug 

applications (ANDAs) from multiple 

applicants, withdrawn as of August 28, 

2024. The document indicated that FDA 

was withdrawing approval of the 

ANDAs 073462 for tolmetin sodium 

capsules, equivalent to (EQ) 400 

milligrams (mg) base; 073588 for 

tolmetin sodium tablets, EQ 200 mg 

base; 074002 for tolmetin sodium 

tablets, EQ 600 mg base; 077040 for 

citalopram hydrobromide tablets, EQ 10 

mg base, EQ 20 mg base; EQ 40 mg base; 

085787 for trifluoperazine 

hydrochloride (HCl) concentrate, EQ 10 

mg base/milliliters (mL); 086808 for 

cyproheptadine HCl tablets, 4 mg; 

087774 for phenylbutazone capsules, 

100 mg; and 088602 for 

pseudoephedrine HCl; triprolidine HCl 

tablets, 60 mg/2.5.mg, held by Fosun 

Pharma USA Inc., 104 Carnegie Center, 

Suite 204, Princeton, NJ 08540. 

Additionally, ANDAS 075631 for 

ketorolac tromethamine injectable, 15 

mg/mL and 30 mg/mL; 076427 for 

milrinone lactate injectable, EQ 1 mg 

base/mL; 076791 for haloperidol lactate 

injectable, EQ 5 mg base/mL; 076828 

haloperidol lactate injectable, EQ 5 mg 

base/mL; 077947 for fluconazole 

injectable, 200 mg/100 mL (2 mg/mL) 

and 400 mg/200 mL (2 mg/mL); 078197 

for granisetron HCl injectable, EQ 0.1 

mg base/mL (EQ 0.1 mg base/mL); 

091436 for levofloxacin injectable, EQ 

500 mg/20 mL (EQ 25 mg/mL); 207101 

for sumatriptan succinate injectable, EQ 

6 mg base/0.5 mL (EQ12 mg base/mL); 

and 215065 for methocarbamol solution, 

1gram/10 mL (100 mg/mL), held by 

Baxter Healthcare Corp., One Baxter 

Parkway, Deerfield, IL 60015; and the 

ANDAs 090367 for levofloxacin tablets, 

250 mg, 500 mg, 750 mg; and 211959 for 

clobazam tablets, 10 mg and 20 mg, held 

by Celltrion USA, Inc., U.S. Agent for 

Celltrion, Inc., One Evertrust Plaza, 

Suite 1207, Jersey City, NJ 07302; and 

the ANDA 212053 for chlorzoxazone 

tablet, 375 mg and 750 mg, held by i3 

Pharmaceuticals LLC, 200 Park Ave., 

Warminster, PA 18974. Before FDA 

withdrew the approval of these ANDAs, 

Fosun Pharma USA Inc.; Baxter 

Healthcare Corp.; Celltrion USA, Inc., 

U.S. Agent for Celltrion, Inc.; and i3 

Pharmaceuticals LLC, 200 Park Ave., 

Warminster, PA 18974, informed FDA 

that they did not want the approval of 

the ANDAs withdrawn. Because Fosun 

Pharma USA Inc.; Baxter Healthcare 

Corp.; Celltrion USA, Inc., U.S. Agent 

for Celltrion, Inc.; and i3 

Pharmaceuticals, LLC, timely requested 

that approval of their respective ANDAs 

not be withdrawn, the approvals are still 

in effect. This notice corrects these 

errors. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 301– 

796–3471, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Monday, July 29, 

2024 (89 FR 60902), appearing on page 

60902 in FR Doc. 2024–16627, the 

following correction is made: 

On page 60902, in the table, the 

entries for ANDA 073462, ANDA 

073588, ANDA 074002, ANDA 075631, 

ANDA 076427, ANDA 076791, ANDA 

076828, ANDA 077040, ANDA 077947, 

ANDA 078197, ANDA 085787, ANDA 

086808, ANDA 087774, ANDA 088602, 

ANDA 090367, ANDA 091436 ANDA 

207101, ANDA 211959, ANDA 212053, 

and ANDA 215065 are removed. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31307 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Update to the Health Resources and 

Services Administration-Supported 

Women’s Preventive Services 

Guidelines 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) 

published a Federal Register Notice on 

October 22, 2024, with proposed 

updates to the HRSA-supported 

Women’s Preventive Services 

Guidelines (Guidelines). The proposed 

updates specifically relate to 

recommendations for Screening and 

Counseling for Intimate Partner and 

Domestic Violence, Breast Cancer 

Screening for Women at Average Risk, 

and Patient Navigation Services for 

Breast and Cervical Cancer Screening. 

Recommendations to update the 

Guidelines are developed by the 

Women’s Preventive Services Initiative 

(WPSI) for consideration by HRSA. 

WPSI convenes expert health 

professionals to conduct rigorous 

reviews of the evidence following the 

National Academy of Medicine 

standards for establishing foundations 

for and rating strengths of 

recommendations, articulation of 

recommendations, and external reviews 

and it develops draft recommendations 

for HRSA’s consideration. After 

consideration of public comment, HRSA 

has accepted the recommendations as 

revised and detailed in this notice. 

Under applicable law, nongrandfathered group health plans and 

health insurance issuers offering nongrandfathered group and individual 

health insurance coverage must include 

coverage, without cost sharing, for 

certain preventive services, including 

those provided for in the HRSAsupported Guidelines. The Departments 

of Labor, Health and Human Services, 

and the Treasury have previously issued 

regulations describing how group health 

plans and health insurance issuers 

apply the coverage requirements. Please 

see https://www.hrsa.gov/womensguidelines for additional information. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Sherman, HRSA, Maternal 

and Child Health Bureau, telephone: 

(301) 443–2170, email: wellwomancare@

hrsa.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106523 

1See https://www.federalregister.gov/documents/ 

2024/10/22/2024-24445/notice-of-request-forpublic-comments-on-draft-recommendations-forthe-hrsa-supported-womens. 

SUPPLEMENTARY INFORMATION: Under the 

Patient Protection and Affordable Care 

Act, Public Law 111–148, the preventive 

care and screenings set forth in the 

HRSA-supported Women’s Preventive 

Services Guidelines (Guidelines) are 

required to be covered without costsharing by certain group health plans 

and health insurance issuers. HRSA 

established the Guidelines in 2011 

based on expert recommendations by 

the Institute of Medicine, now known as 

the National Academy of Medicine, 

developed under a contract with the 

Department of Health and Human 

Services. Since 2016, HRSA has funded 

cooperative agreements with the 

American College of Obstetricians and 

Gynecologists for the Women’s 

Preventive Services Initiative (WPSI) to 

convene a coalition representing 

clinicians, academics, and consumerfocused health professional 

organizations to conduct a rigorous 

review of current scientific evidence, 

solicit and consider public input, and 

make recommendations to HRSA 

regarding updates to the Guidelines to 

improve adult women’s health across 

the lifespan. HRSA then determines 

whether to support, in whole or in part, 

the recommended updates to the 

Guidelines. 

WPSI includes an Advisory Panel and 

two expert committees, the 

Multidisciplinary Steering Committee 

and the Dissemination and 

Implementation Steering Committee, 

which are comprised of a broad 

coalition of experts in disease 

prevention and women’s health issues. 

With oversight by the Advisory Panel, 

and with input from the 

Multidisciplinary Steering Committee, 

WPSI examines the evidence to develop 

new (and update existing) 

recommendations for women’s 

preventive services. WPSI’s 

Dissemination and Implementation 

Steering Committee takes HRSAapproved recommendations and 

disseminates them through the 

development of implementation tools 

and resources for both patients and 

practitioners. 

For clarity, note that the 

Implementation Considerations of the 

WPSI documents address aspects of 

clinical and practical application of the 

Clinical Recommendations. Research 

Recommendations are provided to 

highlight areas where further research 

and clinical trials are needed to inform 

the development of Clinical 

Recommendations. The Implementation 

Considerations and Research 

Recommendations sections are not a 

part of the Clinical Recommendations 

accepted by the HRSA Administrator, 

and therefore have no impact on health 

insurance coverage without costsharing. 

WPSI bases its recommended updates 

to the Guidelines on review and 

synthesis of existing clinical guidelines 

and new scientific evidence, following 

the National Academy of Medicine 

standards for establishing foundations 

for and rating strengths of 

recommendations, articulation of 

recommendations, and external reviews. 

Additionally, HRSA requires that WPSI 

incorporate processes to assure 

opportunity for public comment, 

including participation by patients and 

consumers, in the development of the 

updated Guidelines. 

Discussion of Recommended Updated 

Guidelines 

As is standard practice, HRSA 

published a Federal Register Notice 

seeking public comment regarding the 

proposed updates to the Guidelines (89 

FR 84354).1 WPSI considered all public 

comments as part of its deliberative 

process, provided the comments to 

HRSA for its consideration, and 

submitted final recommended updates 

for Screening and Counseling for 

Intimate Partner and Domestic Violence, 

Breast Cancer Screening for Women at 

Average Risk, and Patient Navigation 

Services for Breast and Cervical Cancer 

Screening. A total of 28 comments were 

received and considered. 

Screening and Counseling for Intimate 

Partner and Domestic Violence 

WPSI largely recommended retaining 

the existing Guideline on Screening and 

Counseling for Intimate Partner and 

Domestic Violence with several minor 

updates. The first proposed change was 

a revision to the title of the Guideline, 

with corresponding revisions 

throughout, to better reflect current 

clinical terminology by replacing 

‘‘Interpersonal and Domestic Violence’’ 

with ‘‘Intimate Partner and Domestic 

Violence.’’ WPSI also recommended 

adding the word ‘‘adult’’ prior to 

‘‘women’’ in the recommendation, to 

clarify that both adolescent and adult 

women are included in the screening 

and counseling guidance. The words 

‘‘referral to’’ were removed from the last 

sentence to improve clarity. 

WPSI received eight comments on 

these proposed updates. One 

commenter suggested adding universal 

education as a mechanism to address 

intimate partner violence in health care 

settings. Based on this comment, WPSI 

added universal education to the 

Implementation Considerations section 

for the recommendation. Another 

comment recommended an expansion of 

research into intimate partner violence, 

which WPSI added to the Research 

Recommendations. Another commenter 

suggested adding referral and consult to 

a forensic medical examiner to the 

recommendation, which was not 

accepted as it was not represented in the 

evidence review for this topic. Several 

commenters supported WPSI’s 

recommendations and one suggested the 

development of continuous care 

frameworks for follow-up services and 

the use of telehealth in support of those 

services. These comments were not 

accepted as they are already included in 

the implementation considerations of 

the recommendation or are beyond the 

scope of the review, which did not 

include the development of a 

continuous care frameworks. One 

comment suggested alignment with the 

U.S. Preventive Services Task Force 

(USPSTF), which describes specific 

populations, including vulnerable 

patients, and another suggested 

specifying the inclusion of ‘‘older adult 

women.’’ These comments were not 

accepted, as WPSI’s evidence review 

and recommendation supports 

screening of all women, not just certain 

vulnerable populations or age groups. 

Breast Cancer Screening for Women at 

Average Risk 

WPSI recommended several updates 

to the existing Guideline on Breast 

Cancer Screening for Women at Average 

Risk. WPSI recommended updates to 

the first sentence of this Guideline, 

replacing the phrase ‘‘average-risk 

women’’ with ‘‘women at average risk 

for breast cancer’’ to clarify the target 

population for this recommendation and 

to use person-first language that puts the 

individual before the diagnosis or 

screening modality. The title was also 

changed from ‘‘Breast Cancer Screening 

for Average-Risk Women’’ to ‘‘Breast 

Cancer Screening for Women at Average 

Risk’’ for similar reasons. Two new 

sentences were added following the first 

sentence: ‘‘Women may require 

additional imaging to complete the 

screening process or to address findings 

on the initial screening mammography. 

If additional imaging (e.g., MRI, 

ultrasound, mammography) and 

pathology exams are indicated, those 

services are also recommended to 

complete the screening process for 

malignancies.’’ These two sentences 

were added to ensure women who need 

additional screening to complete their 

initial screening receive it. Imaging in 

addition to initial screening 


ddrumheller on DSK120RN23PROD with NOTICES1
106524 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

mammography, such as special 

mammography views, ultrasound, or 

MRI, may be needed in individual 

clinical situations when clinicians 

require an enhanced view of breast 

tissue to differentiate normal from 

abnormal findings. A tissue biopsy may 

also need to be performed to determine 

whether abnormal findings are cancer, 

normal tissue, or other type of lesion. 

WPSI also recommended removing the 

following sentence from the existing 

Guideline, ‘‘These screening 

recommendations are for women at 

average risk of breast cancer’’ as this 

information is now included in the 

revised first sentence of the updated 

Guideline. 

WPSI received thirteen comments on 

this proposed update. One comment 

requested a definition for ‘‘women at 

average risk,’’ which is provided in the 

full evidence review and will be 

restated on WPSI’s website, as the 2016 

evidence review defined ‘‘women at 

average risk’’ as those without risk 

factors indicating high risk (includes 

deleterious BRCA mutations and their 

untested first-degree relatives; other 

hereditary genetic syndromes; 

previously diagnosed high-risk breast 

lesions; and history of high dose 

radiation therapy to the chest between 

the ages of 10 to 30 years). Two 

commenters requested screening for 

women under age 40. No change was 

made as WSPI did not document new 

evidence changes in its review. Others 

requested screening for women of 

increased risk. No change was made in 

response to these comments as this 

specific guideline relates to women at 

average risk of breast cancer. Another 

comment requested edits to the 

recommendation related to racial 

disparities and gender inclusivity WSPI 

made no changes given that the 

proposed recommendation is intended 

to address all women at average risk. 

Three commenters requested that the 

recommendation address ‘‘annual 

screening’’ and one commenter opposed 

ending screening at age 74. No changes 

were made based on these comments as 

they were not supported by evidence 

that met WPSI’s inclusion criteria. One 

commenter suggested that the 

recommendation would be clearer if the 

phrase ‘‘pathology exams’’ was changed 

to ‘‘pathology tests.’’ In response to this 

comment, WPSI updated the 

recommendation to ‘‘pathology 

evaluation’’ to improve clarity. Multiple 

commenters requested language to 

address dense breast tissue, and one 

recommended using digital 

mammography for women with dense 

breast tissue. While there are currently 

no randomized controlled trials to 

support separate recommendations for 

women with dense breasts, the updated 

clinical recommendation supports 

additional testing to complete initial 

screening, if needed, which may be 

more common for women with dense 

breasts. No changes were made in 

response to these comments. One 

comment recommended WPSI align 

with the U.S. Preventive Services Task 

Force (USPSTF) recommendations on 

breast cancer screening. No changes 

were made in response to this comment 

as WPSI’s charge differs from that of the 

USPSTF, with WPSI’s statutory 

authority including coverage of 

additional preventive care and 

screenings not described in evidencebased items or services that have a 

rating of ‘‘A’’ or ‘‘B’’ in the current 

recommendations of the USPSTF. 

Patient Navigation Services for Breast 

and Cervical Cancer Screening 

Based on clinical research, patient 

navigation services for breast and 

cervical cancer screening have been 

found to be effective in reducing 

barriers to screening and follow-up care, 

resulting in higher screening rates. 

WPSI recommended a new Guideline on 

Patient Navigation Services for Breast 

and Cervical Cancer Screening. Breast 

cancer screening rates were 14.1% 

higher for 35,752 patients randomized 

to patient navigation services versus 

usual care or active controls in a WPSI 

meta-analysis of 33 randomized control 

trials based in U.S. health care settings. 

The same meta-analysis showed rates 

for cervical cancer screening and followup were higher with patient navigation 

by 15.7%, based on 22 randomized 

control trials with 12,221 participants. 

In one study included in WPSI’s metaanalysis, prevention care managers 

working in federally qualified health 

centers (FQHCs) who employed patient 

navigation services increased breast 

cancer screening among patients 

without a mammogram in the past 18 

months to 68% compared to 57% for 

patients in usual care. 

Research also shows that reducing 

barriers to screening and follow-up care 

can result in earlier identification of 

breast and cervical cancer, enabling 

patients to enter into treatment earlier, 

preventing progression of these 

conditions, improving health outcomes 

and survival rates, and ultimately can 

reduce disparities in cancer morbidity 

and mortality. In the meta-analysis, 

patient navigation services increased 

screening and follow-up for breast 

cancer by 10.2% in populations 

described as low-income. 

WPSI received seven comments on 

this proposed recommendation. 

Comments were generally supportive 

and WPSI appreciated the positive 

feedback. Two commenters 

recommended adding culturally 

appropriate components to patient 

navigation services and addressing 

relevant social determinants of health. 

No changes were made based on these 

comments as these considerations are 

outlined in the Implementation 

Considerations section. Three 

commenters requested including billing 

and coding guidance to support the 

implementation of the recommendation. 

One comment suggested it may be 

premature to release the guideline 

without such information. Under its 

cooperative agreement with HRSA, 

WPSI develops tools and resources for 

patients and providers that include 

information on billing and coding, 

which will be updated to address these 

patient navigation services. Another 

comment requested WPSI expand the 

Research Recommendations to include 

comparative effectiveness trials of 

patient navigation services. WPSI 

updated the Research Recommendations 

to include this suggestion. Two 

commenters questioned the level of 

evidence available to support the 

guideline and one of them requested the 

evidence review. The October 22, 2024, 

Federal Register notice provided data 

from the WPSI evidence review to detail 

the clinical effect of the proposed 

recommendation and the final evidence 

review includes a comprehensive listing 

of the clinical evidence considered by 

WSPI. A final comment requested 

cervical cancer screening guidelines be 

updated. WPSI will begin reviewing the 

evidence for cervical cancer screening 

in 2025, if funds are available to support 

the review. 

Acceptance of Recommendation 

On December 20, 2024, the HRSA 

Administrator accepted WPSI’s 

recommendations, which are revised as 

described above, and, as such, updated 

the HRSA-supported Women’s 

Preventive Services Guidelines. The 

final Guidelines for these topics read as 

follows: 

(1) Screening and Counseling for 

Intimate Partner and Domestic Violence 

The final Guideline for Screening and 

Counseling for Intimate Partner and 

Domestic Violence reads: ‘‘The 

Women’s Preventive Services Initiative 

recommends screening adolescent and 

adult women for intimate partner and 

domestic violence, at least annually, 

and, when needed, providing or 

referring to intervention services. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106525 

Intimate partner and domestic violence 

includes physical violence, sexual 

violence, stalking and psychological 

aggression (including coercion), 

reproductive coercion, neglect, and the 

threat of violence, abuse, or both. 

Intervention services include, but are 

not limited to, counseling, education, 

harm reduction strategies, and 

appropriate supportive services.’’ 

(2) Breast Cancer Screening for Women 

at Average Risk 

The final Guideline for Breast Cancer 

Screening for Women at Average Risk 

reads: ‘‘The Women’s Preventive 

Services Initiative recommends that 

women at average risk of breast cancer 

initiate mammography screening no 

earlier than age 40 years and no later 

than age 50 years. Screening 

mammography should occur at least 

biennially and as frequently as 

annually. Women may require 

additional imaging to complete the 

screening process or to address findings 

on the initial screening mammography. 

If additional imaging (e.g., magnetic 

resonance imaging (MRI), ultrasound, 

mammography) and pathology 

evaluation are indicated, these services 

also are recommended to complete the 

screening process for malignancies. 

Screening should continue through at 

least age 74 years, and age alone should 

not be the basis for discontinuing 

screening. 

Women at increased risk also should 

undergo periodic mammography 

screening, however, recommendations 

for additional services are beyond the 

scope of this recommendation.’’ 

(3) Patient Navigation Services for 

Breast and Cervical Cancer Screening 

The final Guideline for Patient 

Navigation Services for Breast and 

Cervical Cancer Screening reads: ‘‘The 

Women’s Preventive Services Initiative 

recommends patient navigation services 

for breast and cervical cancer screening 

and follow-up, as relevant, to increase 

utilization of screening 

recommendations based on an 

assessment of the patient’s needs for 

navigation services. Patient navigation 

services involve person-to-person (e.g., 

in-person, virtual, hybrid models) 

contact with the patient. Components of 

patient navigation services should be 

individualized. Services include, but are 

not limited to, person-centered 

assessment and planning, health care 

access and health system navigation, 

referrals to appropriate support services 

(e.g., language translation, 

transportation, and social services), and 

patient education.’’ 

Non-grandfathered group health plans 

and health insurance issuers offering 

group or individual health insurance 

coverage must cover without costsharing the services and screenings 

listed on the updated Women’s 

Preventive Services Guidelines for plan 

years (in the individual market, policy 

years) that begin 1 year after this date. 

Thus, for most plans, this update will 

take effect for purposes of the Section 

2713 coverage requirement in 2026. 

Additional information regarding the 

Women’s Preventive Services 

Guidelines can be accessed at the 

following link: https://www.hrsa.gov/ 

womens-guidelines. 

Authority: Section 2713(a)(4) of the 

Public Health Service Act, 42 U.S.C. 

300gg–13(a)(4). 

Carole Johnson, 

Administrator. 

[FR Doc. 2024–31228 Filed 12–27–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Children’s Hospitals Graduate Medical 

Education Payment Program: Updated 

Methodology To Determine Full-Time 

Equivalent Resident Count 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Request for public comment. 

SUMMARY: This notice seeks public 

comment on updating the Children’s 

Hospitals Graduate Medical Education 

(CHGME) Payment Program’s method of 

determining an eligible children’s 

hospital (as defined within the Public 

Health Service Act) weighted allopathic 

and osteopathic full-time equivalent 

(FTE) resident count when a children’s 

hospital’s weighted allopathic and 

osteopathic FTE resident count exceeds 

its direct graduate medical education 

(GME) FTE resident cap in order to be 

consistent with the methodology used 

by the Centers for Medicare & Medicaid 

Services (CMS) beginning in the fiscal 

year (FY) 2026 application cycle. 

DATES: Comments on this notice should 

be received no later than January 29, 

2025. 

ADDRESSES: Written comments should 

be submitted to Robyn Duarte, Public 

Health Analyst, by email RDuarte1@

hrsa.gov. 

FOR FURTHER INFORMATION CONTACT: 

Robyn Duarte, Public Health Analyst, 

Bureau of Health Workforce, Division of 

Medicine and Dentistry, HRSA, 5600 

Fishers Lane, Rockville, MD 20857, 

301–443–3254. 

SUPPLEMENTARY INFORMATION: The 

CHGME Payment Program is authorized 

by section 340E of the Public Health 

Service Act. For direct GME payments, 

section 340E(c)(1)(B) requires that the 

average number of FTE residents in the 

hospital’s approved residency programs 

be determined according to section 

1886(h)(4) of the Social Security Act. As 

noticed in the March 1, 2001, Federal 

Register (66 FR 12940), section 

1886(h)(4) has been implemented by 

regulations at 42 CFR 413.78 through 

413.83 (formerly 42 CFR 413.86(f)–(i)), 

which HRSA has used to determine the 

total and weighted numbers of FTE 

residents. In the CMS FY 2023 inpatient 

prospective payment systems (IPPS) and 

long-term care hospital prospective 

payment system (LTCH PPS) final rule 

published in the Federal Register on 

August 10, 2022 (87 FR 48780, 49065– 

49072) (referred to as the ‘‘FY 2023 

IPPS/LTCH PPS final rule’’), CMS 

modified the Medicare direct GME 

payment methodology and amended 

section 413.79 by revising paragraphs 

(c)(2)(iii) and (d)(3). Through this 

notice, HRSA is seeking comment on its 

intent to adopt the same direct GME 

payment methodology as CMS when 

HRSA calculates FTE residents for the 

CHGME Payment Program beginning in 

the FY 2026 application cycle. 

Background 

To the extent feasible, HRSA has 

historically sought consistency with 

CMS regulations to minimize burden for 

children’s teaching hospitals 

participating in the CHGME Payment 

Program that must also comply with 

CMS regulations. Consistency reduces 

the potential challenges in reporting 

FTE resident counts to Medicare and 

CHGME. 

Currently, the CHGME Payment 

Program methodology for determining 

the weighted allopathic and osteopathic 

FTE resident count applies the direct 

GME FTE resident cap when a hospital’s 

weighted allopathic and osteopathic 

FTE resident count is greater than its 

direct GME FTE resident cap. The 

current CHGME direct GME 

methodology reduces a hospital’s 

weighted direct GME resident count by 

a proportion equal to the ratio of its 

GME FTE resident cap to its unweighted 

direct GME resident count. The direct 

GME FTE resident cap is applied to 

reduce the weighting factor of residents 

who are beyond their initial residency 


ddrumheller on DSK120RN23PROD with NOTICES1