48102 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 

permit evaluation of possible sources of 

conflicts of interest. Members will be 

invited to serve for terms up to 4 years. 

FDA will review all nominations 

received within the specified 

timeframes and prepare a ballot 

containing the names of qualified 

nominees. Names not selected will 

remain on a list of eligible nominees 

and be reviewed periodically by FDA to 

determine continued interest. Upon 

selecting qualified nominees for the 

ballot, FDA will provide those 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting or nonvoting consumer 

representatives will not participate in 

the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: October 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22344 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Proposed Standards for the Children’s 

Hospitals Graduate Medical Education 

Payment Program’s Quality Bonus 

System 

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 establishing a quality 

bonus system for the Children’s 

Hospitals Graduate Medical Education 

(CHGME) Payment Program. The 

CHGME Support Reauthorization Act of 

2013 states that the Secretary may 

establish a quality bonus system, 

whereby the Secretary distributes bonus 

payments to hospitals participating in 

the program that meet standards 

specified by the Secretary. The goal of 

this notice is to seek comment to assist 

HRSA in the development of the 

standards, payment structure, and 

outcome measures for the CHGME 

Quality Bonus System. 

DATES: Submit written comments no 

later than December 15, 2017. 

ADDRESSES: Written comments should 

be submitted to Malena Crawford, 

Public Health Analyst, HRSA, by email 

(MCrawford@hrsa.gov) or by fax (301– 

443–0162). 

FOR FURTHER INFORMATION CONTACT: 

Malena Crawford, Public Health 

Analyst, HRSA, 5600 Fishers Lane, 

Rockville, MD, 20852, (301) 443–7334. 

SUPPLEMENTARY INFORMATION: The 

CHGME Program supports graduate 

medical education (GME) in 

freestanding children’s hospitals. The 

program supports the training of 

primary care pediatricians and pediatric 

medical and surgical subspecialists. The 

CHGME Support Reauthorization Act of 

2013 makes up to 25 percent of the total 

amount appropriated annually in excess 

of $245 million, but not to exceed 

$7,000,000, available to provide 

payments to newly qualified hospitals, 

as defined in section 340E(h) of the 

Public Health Service Act. The statute 

additionally states that the Secretary 

may establish a quality bonus system for 

CHGME hospitals using any remaining 

funds after payments are made to newly 

qualified hospitals. In FY 2017, 

Congress appropriated $300 million to 

the CHGME Program. Of this, 

approximately $4 million in payments 

were made to newly qualified hospitals. 

If funding levels and mechanisms 

remain constant, it is estimated that 

approximately $3 million may be 

available annually for the CHGME 

Quality Bonus System. If the total 

amount available for the CHGME 

Quality Bonus System in a fiscal year is 

less than $2 million, HRSA does not 

plan to implement the CHGME Quality 

Bonus System in that year to minimize 

administrative burden on the hospitals. 

In this case, the funds would be 

disbursed to all eligible hospitals 

(including those newly qualified) 

according to the CHGME formula 

payment methodology. 

HRSA understands the complexities 

involved in designing a GME quality 

improvement initiative. The CHGME 

Quality Bonus System would be the first 

of its kind for any federal GME payment 

program and responds to changes 

occurring in the larger health care arena. 

For example, the Accreditation Council 

for GME, one of the prevailing GME 

accrediting bodies, recently 

implemented new GME program 

requirements around patient safety and 

quality improvement. Many GME 

programs and stakeholders are working 

towards establishing GME quality 

related outcome metrics, but currently 

no widely accepted metrics exist that 

have the ability to distinguish between 

the quality of training provided at 

different hospitals and training 

programs. Additionally, clinical 

outcomes alone may not be appropriate 

measures for establishing a GME quality 

improvement initiative. HRSA would 

like to begin to develop approaches to 

measure and assess the quality of GME 

programs using existing data sources 

initially and then develop new and 

improved data sources as we learn 

which are most informative and useful. 

Quality Bonus Payment in FY 2019— 

Proposal for Public Comment 

HRSA is proposing a multi-step 

implementation in recognition of the 

changing landscape and the need for 

additional data. For FY 2019, HRSA 

proposes a quality bonus system that 

will initially recognize high-level 

engagement of CHGME hospitals in state 

and regional health care transformation, 

as well as engagement of resident 

trainees in these activities. HRSA is 

seeking public comment on the 

timeline, eligibility, standards, 

documentation, and payment structure 

as described below. HRSA is also 

proposing areas for comment for FY 

2020 and beyond. 

Timeline: HRSA anticipates 

implementing the proposed CHGME 

Quality Bonus System standards in FY 

2019 payments (project period October 

1, 2018, through September 30, 2019). 

CHGME Hospital Eligibility: HRSA 

proposes to include all eligible CHGME 

hospitals, including those newly 

qualified, as eligible entities for the 

CHGME Quality Bonus System. 

Quality Bonus System Standards: The 

proposed standards are: (1) 

Demonstration of engagement in stateor regional-level initiatives by a 

children’s hospital to transform 

pediatric health care to improve access, 

quality, and cost effectiveness of health 

care; and (2) demonstration of resident 

trainee engagement in these activities. 

HRSA has identified several 

initiatives involving CHGME hospitals 

that require a significant level of 

engagement. These include federally 

funded efforts such as: Participation in 

a state Medicaid initiative to improve 

access, quality, and cost effectiveness of 

pediatric health care (e.g., a Centers for 

Medicare & Medicaid Services State 

Innovation Model Award or other 

Health Care Innovation Award with a 

state or regional impact); participation 

in the HRSA Maternal and Child Health 

Bureau’s Health Care Delivery System 

Innovations for Children with Medical 

Complexity Collaborative Improvement 

and Innovation Network (CoIIN); or, 

participation in HRSA’s Federal Office 

of Rural Health Policy Rural Health 

Network Development Grant Program. 


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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 48103 

In addition to the partnerships above, 

HRSA is seeking comment on state or 

regional initiatives to consider when 

establishing the qualifying standards for 

the CHGME Quality Bonus System, as 

well as suggestions for how to 

distinguish between levels of 

engagement and performance in a 

meaningful way. 

Documentation: To receive a quality 

bonus payment based upon engagement 

in state- or regional-level pediatric 

health care transformation, CHGME 

hospitals would be required to submit a 

letter from the lead organization, which 

could include the project director for a 

HRSA-supported program or the state 

Medicaid Director, confirming 

participation by the children’s hospital 

in the program and delineating the roles 

and responsibilities of the children’s 

hospital in the program activities. In 

addition, CHGME hospitals would be 

required to submit a brief narrative 

statement describing how CHGME 

trainees are integrated into state- or 

regional-level pediatric health care 

transformation activities and the 

expected benefits for trainees and the 

health systems served by the children’s 

hospital. HRSA is seeking comment on 

this proposed approach including 

opportunities to limit burden and 

streamline the documentation to 

determine whether applicants meet 

standards and distinguish among levels 

of engagement and performance. 

Payment Structure: HRSA proposes 

that CHGME hospitals that meet the 

standards receive a portion of the 

available funds for the CHGME Quality 

Bonus System. HRSA proposes a three 

tiered payment structure to recognize 

the different annual payment levels 

received by CHGME hospitals. Hospitals 

that meet the Quality Bonus Systems 

standards will be evenly divided into 

three tiers based on their combined 

direct and indirect fiscal year payment 

amounts, as calculated per the 

established CHGME program formulas: 

Tier 1: Hospitals that qualify for the 

quality bonus payment that are in the 

lowest third among hospitals that 

qualify for the quality bonus payment of 

calculated CHGME annual payments 

will receive a base payment. 

Tier 2: Hospitals that qualify for the 

quality bonus payment that are in the 

middle third will receive two times the 

base payment. 

Tier 3: Hospitals that qualify for the 

quality bonus payment that are in the 

highest third will receive three times the 

base payment. 

The base payment rate would be 

determined from the total amount 

available and the number of hospitals 

that qualify for the CHGME Quality 

Bonus System in a fiscal year. HRSA 

would also seek to recognize the 

hospital’s level of engagement or 

performance in the bonus amount. 

HRSA is also interested in gathering 

views and suggestions on whether any 

of the existing information that 

hospitals already report to the Centers of 

Medicare and Medicaid Services, HRSA, 

accrediting bodies, and others could be 

used to measure the performance of 

GME programs and related health 

outcomes for FY 2019 or subsequent 

years. This could be individual 

measures or combinations of measures 

that are reported to different entities. 

Quality Bonus Payment in FY 2020 and 

Beyond—Areas for Public Comment 

In future years, HRSA will refine the 

CHGME Quality Bonus System to reflect 

the feedback received from 

stakeholders, as well as advancements 

in the development of standardized 

GME quality measures. To that end, 

HRSA also is requesting comments on 

several areas of the Quality Bonus 

System that will be implemented in FY 

2020 and beyond. For long-term 

implementation, HRSA seeks public 

comments on the following areas: 

CHGME Hospital Eligibility: HRSA 

proposes to include all eligible CHGME 

hospitals, including those newly 

qualified, as eligible entities for the 

CHGME Quality Bonus System. 

Quality Bonus System Measures: 

HRSA is seeking comment on 

appropriate GME outcome measures 

that can assess and distinguish 

performance in meaningful ways. HRSA 

is considering several GME outcome 

measures including resident specialty 

outcomes (e.g., number of graduates in 

high need pediatric specialties), resident 

service outcomes (e.g., service to high 

need rural or underserved 

communities), and children’s hospital 

quality outcomes. As noted above, these 

measures could be existing measures 

that hospitals already report or new 

ones that would be developed or 

improved for use in determining quality 

bonuses. 

Data Sources: HRSA is seeking 

comment on available data sources on 

which to base the Quality Bonus 

System. HRSA is requesting comment 

on data sources that are publicly 

available, will streamline reporting 

requirements, and will limit burden on 

CHGME programs. 

Tiering of Quality Bonus Payments: 

HRSA is requesting comments on 

payment structures to recognize 

hospitals according to their level of 

engagement and/or outcomes while also 

taking into account the different size of 

GME programs. The goal is for payment 

structures to recognize the quality of 

hospitals’ programs considering the 

different circumstances in which 

different children’s hospitals operate 

(e.g., patient severity, size of training 

programs, number of specialties trained, 

etc.) 

Frequency of Review: HRSA plans to 

review and update the CHGME Quality 

Bonus System standards regularly to 

reflect changes in GME and advances in 

measuring GME outcomes. 

Dated: October 5, 2017 

George Sigounas, 

Administrator. 

[FR Doc. 2017–22381 Filed 10–13–17; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Service 

Administration 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, notice 

is hereby given that a meeting is 

scheduled for the Advisory Committee 

on Heritable Disorders in Newborns and 

Children (ACHDNC). This meeting will 

be open to the public but advance 

registration is required. Please register 

online at http://

www.achdncmeetings.org/ by 12:00 p.m. 

Eastern Time on November 6, 2017. 

Information about the ACHDNC can be 

obtained by accessing the following 

Web site: https://www.hrsa.gov/ 

advisorycommittees/mchbadvisory/ 

heritabledisorders/index.html. 

DATES: The meeting will be held on 

Wednesday, November 8, 2017, 9:30 

a.m. to 5:00 p.m. Eastern Time and 

Thursday, November 9, 2017, 9:30 a.m. 

to 3:00 p.m. Eastern Time (meeting 

times are tentative). 

ADDRESSES: This meeting will be held 

in-person at 5600 Fishers Lane, 5th 

Floor Pavilion, Rockville, MD 20857. 

The meeting will also be accessible via 

Webcast. Instructions on how to access 

the meeting via Webcast will be 

provided upon registration. Please note, 

the 5600 Fishers Lane building requires 

security screening on entry. Visitors 

must provide a driver’s license, 

passport, or other form of governmentissued photo identification to be granted 

entry into the facility. Non-US Citizens 

planning to attend in person will need 


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