Federal Register / Vol. 88, No. 171 / Wednesday, September 6, 2023 / Notices 60949 

Medicaid Services (CMS) is the 

recipient agency, and the Department of 

Homeland Security (DHS), United States 

Citizenship and Immigration Services 

(USCIS) is the source agency. 

Authority for Conducting the Matching 

Program 

The principal authority for 

conducting the program is 42 U.S.C. 

18001 et seq. 

Purpose(s) 

The program will provide CMS with 

USCIS data which CMS and state-based 

administering entities will use to 

determine individuals’ eligibility for: 

• initial enrollment in a Qualified 

Health Plan through an Exchange 

established under the Patient Protection 

and Affordable Care Act as amended by 

the Health Care and Education 

Reconciliation Act (42 U.S.C. 18001 et 

seq.); 

• Insurance Affordability Programs 

(IAPs); 

• certificates of exemption from the 

shared responsibility payment; and 

• redeterminations and renewal 

decisions, including appeal 

determinations. 

IAPs include advance payments of the 

premium tax credit and cost sharing 

reductions; Medicaid; Children’s Health 

Insurance Program; and Basic Health 

Program. 

Categories of Individuals 

The individuals whose information 

will be used in the program are 

consumers (applicants and enrollees) 

who receive the eligibility 

determinations and redeterminations 

described in the preceding PURPOSE(S) 

section. 

Categories of Records 

The categories of records used in the 

program are identity, citizenship, and 

immigration status records. The data 

elements are described below. 

To request information from USCIS, 

CMS will query USCIS’ Systematic 

Alien Verification for Entitlements 

(SAVE) system using these data 

elements: Last Name; First Name; 

Middle Name; Date of Birth; One or 

More Immigration Number(s) (e.g., 

Alien Registration/USCIS Number, 

Arrival-Departure Record I–94 Number, 

SEVIS ID Number, Certificate of 

Naturalization Number, Certificate of 

Citizenship Number, or Unexpired 

Foreign Passport Number); and Other 

Information from Immigration 

Documentation (e.g. Country of Birth, 

Date of Entry, Employment 

Authorization Category). 

When the above-listed data that CMS 

uses to query the SAVE system matches 

USCIS data in SAVE, USCIS will return 

query results to CMS that include these 

additional data elements about each 

individual, as relevant: Verification 

Case Number; Citizenship or 

Immigration Data (e.g., immigration 

status/category, immigration class of 

admission, and/or employment 

authorization); and Sponsorship Data 

(e.g., name, address, and Social Security 

number of Form I–864/I–864EZ 

sponsors and Form I–864A household 

members, when applicable). 

System(s) of Records 

The records used in this program will 

be disclosed from the following systems 

of records, as authorized by routine uses 

published in the System of Records 

Notices (SORNs) cited below: 

• CMS Health Insurance Exchanges 

System (HIX), System No. 09–70–0560, 

last published in full at 78 FR 63211 

(Oct. 23, 2013) and amended at 83 FR 

6591 (Feb. 14, 2018). Routine use 3 

permits CMS’ disclosures to USCIS. 

• DHS/USCIS–004 Systematic Alien 

Verification for Entitlements Program, 

85 FR 31798 (May 27, 2020). Routine 

use I permits USCIS’ disclosures to 

CMS. 

[FR Doc. 2023–19174 Filed 9–5–23; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3438–FN] 

Medicare and Medicaid Programs: 

Application From the Accreditation 

Commission for Healthcare (ACHC) for 

Continued CMS-Approval of Its 

Hospital Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces our 

decision to approve the Accreditation 

Commission for Healthcare (ACHC) for 

continued recognition as a national 

accrediting organization for hospitals 

that wish to participate in the Medicare 

or Medicaid programs. 

DATES: The decision announced in this 

notice is applicable on September 25, 

2023 through September 25, 2027. 

FOR FURTHER INFORMATION CONTACT: 

Danielle Adams, (410) 786–8818; or 

Lillian Williams, (410) 786–8636. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a hospital provided that 

certain requirements are met. Section 

1861(e) of the Social Security Act (the 

Act) establishes distinct criteria for 

facilities seeking designation as a 

hospital. Regulations concerning 

provider agreements are at 42 CFR part 

489 and those pertaining to activities 

relating to the survey and certification 

of facilities are at 42 CFR part 488. The 

regulations at 42 CFR part 482 specify 

the minimum conditions that a hospital 

must meet to participate in the Medicare 

program. 

Generally, to enter into an agreement, 

a hospital must first be certified by a 

state survey agency (SA) as complying 

with the conditions or requirements set 

forth in 42 CFR part 482 of our 

regulations. Thereafter, the hospital is 

subject to regular surveys by a SA to 

determine whether it continues to meet 

these requirements. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by a Centers for 

Medicare & Medicaid Services (CMS) 

approved national accrediting 

organization (AO) that all applicable 

Medicare conditions are met or 

exceeded, we will deem those provider 

entities as having met the requirements. 

Accreditation by an AO is voluntary and 

is not required for Medicare 

participation. 

If an AO is recognized by the 

Secretary of the Department of Health 

and Human Services (the Secretary) as 

having standards for accreditation that 

meet or exceed Medicare requirements, 

any provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national AO 

applying for approval of its 

accreditation program under part 488, 

subpart A, must provide CMS with 

reasonable assurance that the AO 

requires the accredited provider entities 

to meet requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the 

approval of AOs are set forth at §§ 488.4, 

488.5 and 488.5(e)(2)(i). The regulations 

at § 488.5(e)(2)(i) require an AO to 

reapply for continued approval of its 

accreditation program every 6 years or 

sooner as determined by CMS. 

The Accreditation Commission for 

Healthcare’s (ACHC) current term of 

approval for their hospital accreditation 

program expires September 25, 2023. 

II. Application Approval Process 

Section 1865(a)(3)(A) of the Act 

provides a statutory timetable to ensure 


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60950 Federal Register / Vol. 88, No. 171 / Wednesday, September 6, 2023 / Notices 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The Act 

provides us 210 days after the date of 

receipt of a complete application, with 

any documentation necessary to make 

the determination, to complete our 

survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

body making the request, describes the 

request, and provides no less than a 30- 

day public comment period. At the end 

of the 210-day period, we must publish 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

On April 14, 2023, we published a 

proposed notice in the Federal Register 

(88 FR 23088), announcing ACHC’s 

request for continued approval of its 

Medicare hospital accreditation 

program. In the April 14, 2023 proposed 

notice, we detailed our evaluation 

criteria. Under section 1865(a)(2) of the 

Act and in our regulations at § 488.5, we 

conducted a review of ACHC’s Medicare 

hospital accreditation application in 

accordance with the criteria specified by 

our regulations, which include, but are 

not limited to the following: 

• An administrative review of 

ACHC’s: (1) corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its hospital surveyors; (4) 

ability to investigate and respond 

appropriately to complaints against 

accredited hospital; and (5) survey 

review and decision-making process for 

accreditation. 

• The comparison of ACHC’s 

Medicare hospital accreditation program 

standards to our current Medicare 

hospital conditions of participation 

(CoPs). 

• A documentation review of ACHC’s 

survey process to do the following: 

++ Determine the composition of the 

survey team, surveyor qualifications, 

and ACHC’s ability to provide 

continuing surveyor training. 

++ Compare ACHC’s processes to 

those we require of state survey 

agencies, including periodic resurvey 

and the ability to investigate and 

respond appropriately to complaints 

against ACHC accredited hospitals. 

++ Evaluate ACHC’s procedures for 

monitoring accredited hospitals it has 

found to be out of compliance with 

ACHC’s program requirements. (This 

pertains only to monitoring procedures 

when ACHC identifies non-compliance. 

If noncompliance is identified by a SA 

through a validation survey, the SA 

monitors corrections as specified at 

§ 488.9(c)). 

++ Assess ACHC’s ability to report 

deficiencies to the surveyed hospitals 

and respond to the hospitals plans of 

correction in a timely manner. 

++ Establish ACHC’s ability to 

provide CMS with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

++ Determine the adequacy of ACHC’s 

staff and other resources. 

++ Confirm ACHC’s ability to provide 

adequate funding for performing 

required surveys. 

++ Confirm ACHC’s policies with 

respect to surveys being unannounced. 

++ Confirm ACHC’s policies and 

procedures to avoid conflicts of interest, 

including the appearance of conflicts of 

interest, involving individuals who 

conduct surveys or participate in 

accreditation decisions. 

++ Obtain ACHC’s agreement to 

provide CMS with a copy of the most 

current accreditation survey together 

with any other information related to 

the survey as we may require, including 

corrective action plans. 

IV. Analysis of and Responses to Public 

Comments on the Proposed Notice 

In accordance with section 

1865(a)(3)(A) of the Act, the April 14, 

2023, proposed notice also solicited 

public comments regarding whether 

ACHC’s requirements met or exceeded 

the Medicare CoPs for hospitals. We 

received one comment in response to 

our proposed notice. 

The commenter expressed concern 

about hospital accreditation programs 

overall and the responsibility of patient 

safety in hospitals. The comment was 

not specific to ACHC. 

We appreciate this comment and the 

concern for patient safety and quality of 

care. We continue to prioritize patient 

safety and our responsibility for 

oversight of AOs. As described in 

Section III, ‘‘Provisions of the Proposed 

Notice’’ of this final notice, we take 

various steps when considering to 

approve or not approve a national AO. 

Each AO wishing to be recognized by 

Medicare as a national AO must go 

through a rigorous process for CMS 

approval. We remain steadfast in our 

commitment to keeping the public 

informed of our evaluation process for 

AOs seeking approval from CMS. 

V. Provisions of the Final Notice 

A. Differences Between ACHC’s 

Standards and Requirements for 

Accreditation and Medicare Conditions 

and Survey Requirements 

We compared ACHC’s hospital 

accreditation requirements and survey 

process with the Medicare CoPs of 42 

CFR part 482, and the survey and 

certification process requirements of 

parts 488 and 489. Our review and 

evaluation of ACHC’s hospital 

accreditation application, which were 

conducted as described in section III. of 

this final notice, yielded the following 

areas where, as of the date of this final 

notice, ACHC has completed revising its 

standards and certification processes in 

order to— 

• Meet the standard’s requirements of 

all the following regulations: 

++ Section 482.22(c)(5)(iii), to fully 

address the requirement that an 

assessment of the patient (in lieu of the 

requirements of paragraphs (c)(5)(i) and 

(ii) of this section) be completed and 

documented after registration, but prior 

to surgery or a procedure requiring 

anesthesia services, when the patient is 

receiving specific outpatient surgical or 

procedural services and when the 

medical staff has chosen to develop and 

maintain a policy that identifies, in 

accordance with the requirements at 

paragraph (c)(5)(v) of this section, 

specific patients as not requiring a 

comprehensive medical history and 

physical examination, or any update to 

it, prior to specific outpatient surgical or 

procedural services. The assessment 

must be completed and documented by 

a physician (as defined in section 

1861(r) of the Act), an oral and 

maxillofacial surgeon, or other qualified 

licensed individual in accordance with 

State law and hospital policy. 

++ Section 482.22(c)(5)(iv), to fully 

address the requirement that the 

medical staff develop and maintain a 

policy that identifies those patients for 

whom the assessment requirements of 

paragraph (c)(5)(iii) of this section 

would apply. The provisions of 

paragraphs (c)(5)(iii), (iv), and (v) of this 

section do not apply to a medical staff 

that chooses to maintain a policy that 

adheres to the requirements of 

paragraphs of (c)(5)(i) and (ii) of this 

section for all patients. 

++ Section 482.22(c)(5)(v), to fully 

address the requirement that the 

medical staff, if it chooses to develop 

and maintain a policy for the 

identification of specific patients to 

whom the assessment requirements in 

paragraph (c)(5)(iii) of this section 

would apply, must demonstrate 

evidence that the policy applies only to 


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Federal Register / Vol. 88, No. 171 / Wednesday, September 6, 2023 / Notices 60951 

those patients receiving specific 

outpatient surgical or procedural 

services as well as evidence that the 

policy is based on. 

++ Section 482.41(b)(2), to address the 

requirements regarding Life Safety Code 

(LSC) waivers. 

++ Section 482.41(b)(7), to address the 

requirements regarding alcohol-based 

hand rub (ABHR) dispensers. 

In addition to the standards review, 

CMS also reviewed ACHC’s comparable 

survey processes, which were 

conducted as described in section III., of 

this notice, and yielded the following 

areas where, as of the date of this final 

notice, ACHC has completed revising its 

survey processes to demonstrate that it 

uses survey processes that are 

comparable to state survey agency 

processes by: 

• Revising the complaint response 

policies and processes to align with the 

State Operations Manual, Chapter 5 

guidance. ACHC revised its 

Administrative Review Offsite 

Investigation process to align with CMS’ 

triage process to track and trend for 

potential focus areas during the next 

onsite survey or complete an onsite 

complaint investigation. 

• Revising ACHC’s hospital 

accreditation process policies to include 

the applicable sections of the Health 

Care Facilities Code National Fire 

Protection Agency (NFPA 99) in 

accordance with section 482.41(c). 

• Ensuring that all hospital LSC 

surveyors have received comparable and 

adequate training or have sufficient 

experience to make them qualified to 

survey health care facilities for 

compliance with both the 2012 LSC and 

2012 NFPA 99 requirements. 

• Providing guidance and instruction 

to surveyors on determining the 

appropriate level of citation for LSC 

deficiencies. 

B. Term of Approval 

Based on our review and observations 

described in section III. and section V. 

of this final notice, we approve ACHC 

as a national accreditation organization 

for hospitals that request participation 

in the Medicare program. The decision 

announced in this final notice is 

effective September 25, 2023, through 

September 25, 2027 (4 years). In 

accordance with § 488.5(e)(2)(i) the term 

of the approval will not exceed 6 years. 

While ACHC has taken actions based 

on the findings annotated in section 

V.A., of this final notice, (Differences 

Between ACHC’s Standards and 

Requirements for Accreditation and 

Medicare Conditions and Survey 

Requirements) as authorized under 

§ 488.8, we will continue ongoing 

review of ACHC’s hospital processes to 

ensure full implementation and 

sustained compliance. In keeping with 

CMS’s initiative to increase AO 

oversight broadly and ensure that our 

requested revisions by ACHC are fully 

implemented, CMS expects more 

frequent review of ACHC’s activities in 

the future. 

VI. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or third 

party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Evell J. Barco Holland, who 

is the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: August 31, 2023. 

Evell J. Barco Holland, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–19195 Filed 9–5–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1981] 

Drug Supply Chain Security Act 

Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘DSCSA 

Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs.’’ This guidance identifies the 

standards necessary to facilitate 

adoption of secure, interoperable, 

electronic data exchange among the 

pharmaceutical distribution supply 

chain, and clarifies the trading partners, 

products, and transactions subject to 

such standards. This guidance finalizes 

the revised draft guidance of the same 

title, ‘‘DSCSA Standards for the 

Interoperable Exchange of Information 

for Tracing of Certain Human, Finished, 

Prescription Drugs,’’ issued in July 

2022, as required by the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 6, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–D–1981 for ‘‘DSCSA Standards for 

the Interoperable Exchange of 

Information for Tracing of Certain 


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