Federal Register / Vol. 88, No. 207 / Friday, October 27, 2023 / Notices 73859 

instruments are tailored to reflect the 

steps in each type of process, as well as 

the average time it takes to complete 

each process. The information 

collection will: 

• Allow beneficiaries to directly 

provide feedback about the services they 

receive under the QIO program; 

• Provide quality improvement data 

for QIOs to improve the quality of 

service delivered to Medicare 

beneficiaries; and 

• Provide evaluation metrics for CMS 

to use in assessing performance of QIO 

contractors. 

To achieve the above goals, 

information collection will include: 

Experience Survey: The Experience 

Survey will be administered via 

telephone and mail to beneficiaries/ 

representatives after the Quality of Care 

(Medical Record Review) complaint/ 

Immediate Advocacy/appeal case has 

been closed. The goal of the Experience 

Survey is to assess beneficiary overall 

and specific experiences with the BFCC 

QIOs. Form Number: CMS–10393 (OMB 

control number: 0938–1177); Frequency: 

Once; Affected Public: Individuals or 

households; Number of Respondents: 

9,000; Number of Responses: 9,000; 

Total Annual Hours: 2,250. (For policy 

questions regarding this collection, 

contact Renee Graves-Dorsey at 410– 

786–7142.) 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Medicare Health 

Outcomes Survey Field Test; Use: CMS 

is required to collect and report quality 

and performance of Medicare health 

plans under provisions of the Social 

Security Act. Specifically, Section 

1851(d) of the Act (Providing 

Information to Promote Informed 

Choice) requires CMS to collect data for 

MA plan comparison, including data on 

enrollee satisfaction and health 

outcomes, and report this information 

and other plan quality and performance 

indicators to Medicare beneficiaries 

prior to the annual enrollment period. 

The HOS meets the requirement for 

collecting and publicly reporting quality 

and other performance indicators, as 

HOS survey measures are incorporated 

into the Medicare Part C Star Ratings 

that are published each fall for 

consumers on the Medicare website. 

This request is to conduct a field test 

with the goal of evaluating the 

measurement properties of new survey 

items, and the effects of new content 

and a web-based mode on response 

patterns and measure scores as 

compared to existing HOS survey items 

and protocols. Within each of the 

proposed field test protocol arms, there 

will be two versions of the 

questionnaire (see Attachments A and 

B) that will be identical except for slight 

differences in selected items where 

empirical data are needed to ascertain 

which of the two versions produces the 

best results (see Attachment C). The two 

versions of the questionnaire will test 

alternatives for selected new survey 

content that will potentially enhance 

and refine existing measures, allow 

CMS to develop new and 

methodologically simpler crosssectional and longitudinal measures, 

expand on CMS’s measurement of 

physical functioning and mental health, 

and add to CMS’s efforts to measure and 

address health equity. 

The data collected in this field test 

will be used by CMS to inform decisions 

on possible changes to HOS content and 

survey administration procedures. The 

items in the questionnaire reflect 

current health priorities and would 

provide CMS with data to study new 

longitudinal PROMs, cross-sectional 

measures, and enhancements to existing 

HOS measures for MA plans to use as 

a focus of their quality improvement 

efforts. Potential new measures derived 

from new HOS items will go through the 

Measures Under Consideration (MUC) 

process and rule-making before they are 

added to Star Ratings. Form Number: 

CMS–10861 (OMB Control Number: 

0938–New); Frequency: Once; Affected 

Public: Individuals and Households; 

Number of Respondents: 136; Number 

of Responses: 6,800; Total Annual 

Hours: 2,267. (For policy questions 

regarding this collection contact 

Kimberly DeMichele at 410–786–4286.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Notice of Denial 

of Medicare Prescription Drug Coverage; 

Use: Part D plan sponsors are required 

to issue the Notice of Denial of Medicare 

Prescription Drug Coverage notice when 

a request for a prescription drug or 

payment is denied, in whole or in part. 

The written notice must include a 

statement, in understandable language, 

the reasons for the denial and a 

description of the appeals process. 

The purpose of this notice is to 

provide information to enrollees when 

prescription drug coverage has been 

denied, in whole or in part, by their Part 

D plans. The notice must be readable, 

understandable, and state the specific 

reasons for the denial. The notice must 

also remind enrollees about their rights 

and protections related to requests for 

prescription drug coverage and include 

an explanation of both the standard and 

expedited redetermination processes 

and the rest of the appeal process. Form 

Number: CMS–10146 (OMB control 

number 0938–0976); Frequency: Daily; 

Affected Public: Private sector (Business 

or other for-profits); Number of 

Respondents: 743; Total Annual 

Responses: 2,631,728; Total Annual 

Hours: 657,932. (For policy questions 

regarding this collection contact: Coretta 

Edmondson at 410–786–0512.) 

Dated: October 24, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–23741 Filed 10–26–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Registration Requirements in the 340B 

Drug Pricing Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS or 

Department). 

ACTION: Notice. 

SUMMARY: HRSA is issuing this Notice to 

inform and remind stakeholders of the 

registration requirements for off-site, 

outpatient hospital facilities to 

participate in the 340B Drug Pricing 

Program (340B Program). This Notice 

applies to all hospital types that 

participate in the 340B Program. 

FOR FURTHER INFORMATION CONTACT: 

Questions should be directed to 

Michelle Herzog, Deputy Director, 

Office of Pharmacy Affairs, Office of 

Special Health Initiatives, HRSA, 5600 

Fishers Lane, Room 8W12, Rockville, 

MD 20857, or by telephone at 301–594– 

4353. 

SUPPLEMENTARY INFORMATION: Section 

340B(a)(4) of the Public Health Service 

Act (PHS) Act (42 U.S.C. 256b) lists the 

various types of organizations (‘‘covered 

entities’’) eligible to participate in and 

benefit from the 340B Program. Section 

340B(d)(2)(B)(i and ii) of the PHS Act 

requires the development of a system by 

which covered entities can attest to, and 

HRSA can verify, continued accuracy of 

information in the 340B database and 

compliance with 340B Program 

requirements. Section 340B(a)(9) of the 

PHS Act requires the Secretary to notify 

participating manufacturers of the 

identity of those organizations that meet 

the definition of covered entity under 

340B(a)(4). Section 340B(d)(2)(B)(iv) of 

the PHS Act includes requirements for 

the establishment of a standardized 


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identification system whereby each 

covered entity site can be identified by 

manufacturers for purposes of 

facilitating the ordering, purchasing, 

and delivering of covered outpatient 

drugs. To fulfill these statutory 

requirements, all covered entities and 

their associated sites must be registered 

and listed in the 340B Office of 

Pharmacy Affairs Information System 

(OPAIS). 

Section 340B(a)(4) of the PHS Act 

defines the types of entities eligible to 

participate in the 340B Program. Section 

340B(a)(4)(L) states that a subset of 

Medicare disproportionate share 

hospitals (DSHs), as defined in section 

1886(d)(1)(B) of the Social Security Act 

(SSA), are eligible for the 340B Program. 

Sections 340B(a)(4)(M–O) state that 

certain sole community hospitals, rural 

referral centers, critical access hospitals, 

children’s hospitals, and free-standing 

cancer hospitals qualify for the 340B 

Program. Section 340B(a)(6) indicates 

that qualification of one part of an 

institution as a covered entity does not 

qualify all parts of the institution as a 

covered entity. With regard to hospital 

covered entities, HRSA published final 

guidelines on the participation of offsite, outpatient facilities in the 340B 

Program in the Federal Register at 59 

FR 47884 (Sept. 19, 1994) and provided 

OPAIS registration instructions at 

https://www.hrsa.gov/opa/registration. 

To be registered and continue to be 

listed in OPAIS as participating in the 

340B Program, a hospital covered 

entity’s off-site, outpatient facility must 

(1) be listed as reimbursable on the 

hospital’s most recently filed Medicare 

Cost Report and (2) have associated 

outpatient costs and charges on the most 

recently filed Medicare Cost Report, 

which is filed with the Centers for 

Medicare & Medicaid Services (CMS). 

This applies to all hospital types that 

are eligible for the 340B Program as 

outlined above. After being registered, if 

an off-site, outpatient facility is no 

longer reimbursable on the hospital’s 

most recently filed Medicare Cost 

Report or if a facility no longer has 

outpatient costs and charges on the 

hospital’s most recently filed Medicare 

Cost Report, then the facility is not 

eligible for participation in the 340B 

Program. 

CMS regulations at 42 CFR 413.65 

outline the standards for provider-based 

clinics that must be met for 

reimbursement purposes under the 

Medicare Program. Specifically, 42 CFR 

413.65(e) provides a number of 

additional requirements that off-campus 

facilities or organizations must satisfy, 

including demonstrating a ‘‘a high level 

of integration with the main provider.’’ 

Approval of provider-based status 

requires submission of documentation 

demonstrating the off-campus facility’s 

services are provided to the same 

patient population as the main provider. 

For all hospital types eligible to 

participate in the 340B Program, HRSA 

requires submission of the most recently 

filed Medicare Cost Reports, in order to 

ensure that off-site, outpatient facilities 

comply with 340B Program eligibility 

requirements. Specifically, to be 

considered eligible for the 340B 

Program, under HRSA’s longstanding 

guidance (59 FR 47884, Sept. 19, 1994) 

an off-site, outpatient facility needs to 

be reimbursable on a hospital’s most 

recently filed Medicare Cost Report. 

Because the 340B Program is by statute 

a discount drug purchasing program for 

covered outpatient drugs (see section 

340B(a)(1) of the PHS Act), the hospital 

must indicate that the off-site, 

outpatient facility also has associated 

outpatient costs and charges as 

evidenced on the hospital’s most 

recently filed Medicare Cost Report. To 

meet the statutory requirements at 

340B(a)(9) and (d)(2)(B)(iv) of the PHS 

Act, the off-site, outpatient facility must 

also be listed in OPAIS. 

As part of the government’s efforts to 

respond to the unprecedented 

circumstances of the COVID–19 Public 

Health Emergency (PHE), HHS allowed 

various flexibilities across many of the 

Department’s programs, including the 

340B Program. In June 2020, the 

Frequently Asked Questions (FAQ) 

section of the Office of Pharmacy 

Affairs’ COVID–19 resources web page 

announced the availability of a waiver 

of the requirement that off-site, 

outpatient facilities be (1) listed as 

reimbursable on the hospital’s Medicare 

Cost Report prior to participating in the 

340B Program; and (2) registered and 

listed in OPAIS prior to participating in 

the 340B Program. The FAQ stated that 

for those ‘‘. . . hospitals who are unable 

to register their outpatient facilities 

because they are not yet [emphasis 

added] on the most recently filed 

Medicare Cost Report, the patients of 

the new site may still be 340B eligible 

to the extent that they are patients of the 

covered entity.’’ 

The information on the COVID–19 

resource web page reflected that the 

waiver was implemented in recognition 

of the need for hospitals to quickly 

respond to the rapidly evolving 

conditions of the COVID–19 pandemic 

and assist in creating efficiencies for 

hospitals to adjust operations in that 

response. For example, by providing 

hospitals the ability to quickly move a 

clinic from within the four walls of a 

hospital to outside the hospital to 

expand capacity for care for patients 

with COVID–19 while lessening the 

exposure risk for other patients needing 

access to outpatient care. The FAQ also 

recognized that during the COVID–19 

public health emergency, hospitals had 

to transition certain clinic functions to 

meet the needs of the patients (i.e., shift 

of an outpatient surgery center to an 

urgent care or emergency room) and 

prioritize care accordingly. As stated on 

the COVID–19 resources web page, 

HRSA encouraged hospitals to 

document these situations in their 

policies and procedures and reminded 

these covered entities of their 

responsibility to demonstrate 

compliance with all 340B Program 

requirements, including compliance 

with diversion and duplicate discounts, 

and ensure that auditable records are 

available for any 340B drugs dispensed 

to patients. As indicated in the FAQ, 

this waiver was only intended for offsite, outpatient facilities that would be 

listed as reimbursable on the hospital’s 

future Medicare Cost Report. 

Various HRSA program integrity 

efforts conducted since the start of the 

COVID–19 PHE have demonstrated that 

the waiver has added risk and 

complexity to HRSA’s ability to 

effectively oversee ongoing compliance 

in the 340B Program. Further, the 

circumstances of COVID–19 are no 

longer rapidly evolving in a manner that 

requires significant unplanned activities 

or changes by hospital covered entities 

to accommodate these exigencies or 

adjust operations without planning for 

additional requirements to conduct 

business. The COVID–19 public health 

emergency ended on May 11, 2023, and 

hospitals have generally returned to 

regular operations. 

Accordingly, HRSA has determined 

that ending the waiver is appropriate at 

this time given that, as described above, 

there are no longer exigent 

circumstances of a nationwide public 

health emergency that require allowing 

hospitals to expeditiously adjust their 

operations and locations for providing 

care off-site while maintaining 

immediate access to the 340B Program 

resources. By ending the waiver, HRSA 

will more effectively administer the 

program and support program integrity 

efforts. This Notice is being issued to 

provide clarity to stakeholders and 

provide a sufficient time period during 

which hospitals may take efforts to 

bring their operations into compliance. 

In ending this waiver, HRSA maintains 

its original policy goals in requiring 

certain criteria for off-site, outpatient 

facility registration on an ongoing basis. 

This includes: 


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• HRSA utilizes a hospital’s most 

recent Medicare Cost Report filing to 

verify eligibility of off-site, outpatient 

facilities. As cited above, this is the 

standard that the 340B Program has 

used for decades, and it is HRSA’s 

policy goal to maintain the continuity of 

the most recently filed Medicare Cost 

Report standard to determine hospital 

off-site, outpatient eligibility for the 

340B Program. HRSA is unable to verify 

the eligibility of 340B Program 

participants when off-site, outpatient 

facilities are permitted to participate 

prior to their inclusion on the most 

recently filed Medicare Cost Report. 

Further, HRSA has a long-established 

standard of requiring not only the 

hospital, but the specific off-site, 

outpatient facility utilizing the 

discounts to be listed on the hospital’s 

most recently filed Medicare Cost 

Report. This is to ensure that a hospital 

with multiple locations may only seek 

participation in and remain in the 

program for sites that meet all eligibility 

requirements. 

• HRSA requires off-site, outpatient 

facilities to be registered and listed in 

OPAIS in alignment with the 

transparency provisions of the 340B 

statute at sections 340B(a)(9) and 

(d)(2)(B)(iv) of the PHS Act. When these 

facilities participate without first being 

registered and listed in OPAIS, as 

occurred under the waiver, it can create 

confusion and make efforts to audit or 

determine compliance difficult because 

HRSA, states, and drug manufacturers 

do not have uniform and comprehensive 

visibility into which sites are eligible to 

purchase 340B drugs. OPAIS is a 

centralized resource not just for HRSA, 

but also for manufacturers and states, 

who use it to plan operations (such as 

distribution) that may adjust depending 

on the number of facilities in a given 

location. 

• Section 340B(a)(5)(A) of the PHS 

Act prohibits duplicate discounts in the 

340B Program. This occurs when a 

manufacturer provides both a Medicaid 

rebate and a 340B discount on the same 

drug. HRSA’s Medicaid Exclusion File 

(MEF) is a mechanism used to prevent 

duplicate discounts in Medicaid Fee-for 

Service for 340B drugs and serves as the 

official data source to determine 

whether 340B drugs are billed to 

Medicaid. The waiver increases the risk 

of duplicate discounts as unregistered 

sites cannot be listed on the MEF, as 

only sites registered and listed in OPAIS 

can be added to the MEF. Therefore, 

manufacturers and states would not 

know which sites use 340B for their 

Medicaid patients, as the MEF is used 

by them to decrease the likelihood of 

duplicate discounts. Requiring 

registration of sites to obtain access to 

340B discounts on drugs may also 

decrease the risk of diversion that drugs 

would be dispensed to individuals for 

whom HRSA is unable to verify their 

patient eligibility status. 

In addition to the foregoing policy 

goals, audits of covered entities suggest 

that the waiver is widely used by 

covered entities though it is no longer 

necessary to meet the unique challenges 

due to the unprecedented COVID–19 

pandemic. For example, in FY 2023 

audits of hospital covered entities, 

HRSA found that more than one-third of 

those hospital covered entities were 

using 340B drugs in unregistered sites, 

and those hospital covered entities 

reported that the unregistered sites 

would be listed on a future Medicare 

Cost Report. However, as of May 11, 

2023, those off-site, outpatient facilities 

were not registered in OPAIS, causing 

significant challenges for HRSA to 

determine compliance for these 

participating sites, as it was unclear 

whether the unregistered sites would 

ever be eligible and an integral part of 

a 340B hospital. In that time period 

between the audits and May 11, 2023, 

hospitals should have been able to 

register offsite, outpatient facilities on 

OPAIS. Although these covered entities 

made representations to HRSA that 

those offsite, outpatient sites would be 

registered on the next filed Medicare 

Cost Report, HRSA has found that 

despite these representations, those 

covered entities did not attempt to bring 

those sites into compliance with HRSA 

requirements. As another example and 

as part of ongoing program integrity 

initiatives, HRSA recently engaged in 

risk-based program integrity efforts 

focused on hospitals that were at higher 

risk of compliance issues due to volume 

of purchases; number of off-site, 

outpatient sites; or prior audit findings. 

Specific to these efforts, HRSA sent 

letters in March 2023 to 60 hospitals 

containing a series of questions and 

information requests regarding program 

compliance, including the use of 340B 

drugs at off-site, outpatient facilities. 

Recipients of the letters included the 20 

hospitals with the highest volume of 

purchases in the 340B Program, the 20 

hospitals with the highest numbers of 

off-site, outpatient facilities in the 340B 

Program, and 20 additional covered 

entities that had other potential 

compliance risks. Based on analysis of 

Medicare Cost Report data, HRSA found 

that 27 of the 60 hospitals utilized 340B 

drugs at sites that were not listed on the 

most recently filed Medicare Cost 

Report. HRSA also found that some 

hospitals did not maintain that their 

offsite, outpatient facilities continued to 

have outpatient costs and charges on the 

most recently filed Medicare Cost 

Report. For sites that are using 340B 

drugs, but not listed on the hospital’s 

most recently filed Medicare Cost 

Report, do not have associated 

outpatient costs and charges, or 

registered in OPAIS, HRSA cannot 

verify whether use of 340B drugs at 

those sites for patients is warranted, 

leading to possible diversion and 

duplicate discounts. Accordingly, HRSA 

determined that there is a need to verify 

off-site, outpatient facilities prior to 

their participation in the 340B program 

and on an on-going basis to ensure that 

they continue to meet 340B Program 

eligibility criteria. 

HRSA’s audit and other program 

integrity activities related to off-site, 

outpatient facilities highlight the 

increased 340B Program compliance 

risks associated with hospitals 

continuing to use a waiver that is no 

longer necessary. As some covered 

entities believed the waiver would 

continue indefinitely and would not be 

tied to the end of the PHE, HRSA is 

providing a transition period for 

covered entities to come into 

compliance with the off-site, outpatient 

facility registration requirements. This 

transition period will provide the 

opportunity for all hospitals to register, 

or take affirmative efforts to come into 

compliance with program requirements 

within an appropriate time. The burden 

of registration and including a facility in 

the next filed Medicare Cost Report does 

not take significant resources, and 

hospitals making good faith efforts to 

come into compliance should be able to 

adjust operations within this transition 

time period. Additionally, as was stated 

on the COVID–19 resources web page, 

HRSA encouraged hospitals to 

document situations in which the 

waiver was utilized and ensure that 

auditable records were available for any 

340B drugs dispensed to patients. 

Accordingly, HRSA expects that the 

information needed for hospitals to 

register, or take affirmative efforts to 

come into compliance, should be 

readily available to affected hospital 

covered entities. HRSA will enforce its 

longstanding registration requirements 

as outlined below. 

I. Transition Period for Registration of 

Off-Site, Outpatient Facilities 

HRSA’s approach to enforcement of 

340B registration requirements will 

occur as follows: 

1. HRSA will continue to allow offsite, outpatient facilities that are 

currently listed on the hospital’s most 

recently filed Medicare Cost Report with 


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associated outpatient costs and charges, 

but that have not yet registered in 

OPAIS, to continue to use 340B drugs 

for patients of the covered entity 

pending registration of the facility in 

OPAIS during the next 340B Program 

quarterly registration period (January 1– 

16). If a facility is not registered during 

January 1–16 quarterly registration 

period, the hospital covered entity may 

be subject to audit and compliance 

action. 

2. HRSA will continue to allow offsite, outpatient facilities that are not yet 

listed as a reimbursable facility on the 

hospital’s most recently filed Medicare 

Cost Report with associated outpatient 

costs and charges to continue to use 

340B drugs for patients of the covered 

entity if the following conditions are 

met: 

a. The off-site, outpatient facility was 

opened and began using 340B drugs 

prior to the publication date of this 

Notice; and 

b. The hospital that is the covered 

entity and the parent organization for 

the off-site, outpatient facility provides 

HRSA, via email to 340Bcompliance@

hrsa.gov within 90 days of publication 

date of this Notice, with the following 

information consistent with 340B 

registration requirements: 

• The name of the off-site, outpatient 

facility; 

• The date the site will be listed on 

the hospital’s Medicare Cost Report (this 

must be the next filed Medicare Cost 

Report) with associated outpatient costs 

and charges; and 

• The date the covered entity will 

register the site in OPAIS. 

If a covered entity does not provide 

this information within 90-days of 

publication of this Notice, any off-site, 

outpatient facility that is not listed on 

the most recently filed Medicare Cost 

Report with associated outpatient costs 

and charges will have to cease 

purchasing 340B drugs for use at those 

facilities and will be subject to audit 

and compliance action. Consistent with 

longstanding 340B Program 

requirements, covered entities that 

provide this information within 90 days 

of publication must subsequently 

register in OPAIS at the soonest possible 

opportunity (and no later than the dates 

listed in the information provided to 

HRSA), and recertify in OPAIS annually 

with the most recently filed Medicare 

Cost Report with associated outpatient 

costs and charges. 

3. Hospital covered entities using 

340B drugs at off-site, outpatient 

facilities that are not listed on the most 

recently filed Medicare Cost Report with 

associated outpatient cost and charges, 

are not in OPAIS, and do not meet 

categories 1 or 2 above are out of 

compliance and must stop using 340B 

drugs at these unregistered sites as soon 

as practically possible, but no later than 

90 days after the publication of this 

Federal Register Notice. After the 90-day 

grace period, non-compliant covered 

entities may be subject to audit and 

compliance action. HRSA is allowing 

for a 90-day grace period for affected 

hospitals to come into compliance and 

does not believe that any undue burden 

would be caused by reverting back to its 

original program guidelines, which have 

been in place since 1994. 

II. Other Deadlines 

Deadlines for 340B Program 

requirements other than those listed 

above are not affected by this Notice. All 

other registrations and change requests 

are not affected by this Notice and will 

be processed as they are received. 

Carole Johnson, 

Administrator. 

[FR Doc. 2023–23702 Filed 10–26–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Information Technology 

Advisory Committee Schedule of 

Meetings 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), HHS. 

ACTION: Notice of meetings. 

SUMMARY: The Health Information 

Technology Advisory Committee 

(HITAC) was established in accordance 

with the 21st Century Cures Act and the 

Federal Advisory Committee Act. The 

HITAC, among other things, identifies 

priorities for standards adoption and 

makes recommendations to the National 

Coordinator for Health Information 

Technology (National Coordinator). The 

HITAC will hold public meetings for the 

remainder of 2023 and throughout 2024. 

See list of public meetings below. 

FOR FURTHER INFORMATION CONTACT: 

Michael Berry, Designated Federal 

Officer, at Michael.Berry@hhs.gov, (202) 

701–0795. 

SUPPLEMENTARY INFORMATION: Section 

4003(e) of the 21st Century Cures Act 

(Pub. L. 114–255) establishes the Health 

Information Technology Advisory 

Committee (referred to as the ‘‘HITAC’’). 

The HITAC will be governed by the 

provisions of the Federal Advisory 

Committee Act (FACA) (Pub. L. 92– 

463), as amended, (5 U.S.C. app.), which 

sets forth standards for the formation 

and use of federal advisory committees. 

Composition: The HITAC is 

comprised of at least 25 members, of 

which: 

• No fewer than 2 members are 

advocates for patients or consumers of 

health information technology; 

• 3 members are appointed by the 

HHS Secretary 

Æ 1 of whom shall be appointed to 

represent the Department of Health and 

Human Services and 

Æ 1 of whom shall be a public health 

official; 

• 2 members are appointed by the 

majority leader of the Senate; 

• 2 members are appointed by the 

minority leader of the Senate; 

• 2 members are appointed by the 

Speaker of the House of Representatives; 

• 2 members are appointed by the 

minority leader of the House of 

Representatives; 

• Other members are appointed by 

the Comptroller General of the United 

States. 

Members serve for one-, two-, or 

three-year terms. All members may be 

reappointed for a subsequent three-year 

term. Each member is limited to two 

three-year terms, not to exceed six years 

of service. Members serve without pay 

but will be provided per-diem and 

travel costs for committee services, if 

warranted. 

Recommendations: The HITAC 

recommendations to the National 

Coordinator are publicly available at 

https://www.healthit.gov/topic/federaladvisory-committees/recommendationsnational-coordinator-health-it. 

Public Meetings: All HITAC meetings 

will be virtual. Please note that some 

HITAC meetings may also have an inperson meeting option. For web 

conference instructions and the most 

up-to-date information, including inperson meeting location (if applicable), 

please visit the HITAC calendar on the 

ONC website, www.healthit.gov/topic/ 

federal-advisory-committees/hitaccalendar. 

The schedule of remaining meetings 

to be held in 2023 and throughout 2024 

is as follows: 

• November 9, 2023, from 

approximately 9:30 a.m. to 4:00 p.m./ 

Eastern Time (virtual and in-person 

meeting options, address: Hubert H. 

Humphrey Federal Building, 200 

Independence Ave SW, Washington, 

DC 20201) 

• January 18, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• February 8, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• March 7, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• April 11, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 


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