Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38697 

program enables CMS to compare its 

data to SSA data to confirm an 

applicant’s or other relevant 

individual’s identity, citizenship, status 

as deceased or imprisoned, and Title II 

disability benefit quarters of coverage 

(QC) and monthly and annual income. 

The data is used by CMS to authenticate 

identity, determine eligibility, and 

determine the amount of an advance 

payment of the premium tax credit 

(APTC) or cost sharing reduction (CSR). 

CATEGORIES OF INDIVIDUALS: 

The categories of individuals whose 

information is involved in the matching 

program are consumers who apply for 

any of the following eligibility 

determinations, and other relevant 

individuals (e.g., an applicant’s 

household members) who have 

eligibility to enroll in a qualified health 

plan through an exchange established 

under the ACA, eligibility for insurance 

affordability programs and certificates of 

exemption, and subsequent eligibility 

redeterminations and renewals, 

including appeal determinations. 

CATEGORIES OF RECORDS: 

The categories of records used in the 

matching program are identity, 

citizenship, birth, death, disability 

coverage and income, and 

imprisonment status records. The data 

elements are as follows: 

1. For each applicant and for relevant 

individuals, CMS will submit a request 

file to SSA that contains the following 

mandatory specified data elements in a 

fixed record format: Last name, first 

name, date of birth, social security 

number (SSN), and citizenship 

indicator. 

2. For each applicant, SSA will 

provide CMS with a response file in a 

fixed record format. Depending on CMS’ 

request, SSA’s response may include the 

following data elements: Last name, first 

name, date of birth, death indicator, 

disability indicator, prisoner 

information, Title II (annual and 

monthly) income information, and 

confirmation of attestations of 

citizenship status and SSN. SSA may 

also provide QC data when CMS 

requests it. 

3. For relevant individuals, CMS will 

request a limited amount of SSA 

information. Based on CMS’ request, 

SSA will verify a relevant individual’s 

SSN with a death indicator and may 

provide a relevant individual’s QC data 

or Title II (annual and monthly) income 

information. CMS will not request 

citizenship or immigration status data 

for a relevant individual. 

4. For renewals and redeterminations, 

CMS will request and SSA will verify 

SSN with a death indicator, disclose 

Title II income information, and provide 

the disability indicator. 

5. For self-reported redeterminations, 

CMS will provide SSA with the 

following: Updated or new information 

reported by the enrollee or enrolled 

individual, last name, first name, date of 

birth, and SSN. Depending on CMS’ 

request, SSA’s response will include 

each of the following data elements that 

are relevant and responsive to CMS’ 

request: Last name, first name, date of 

birth, death indicator, disability 

indicator, prisoner information, Title II 

(annual and monthly) income 

information, and confirmation of new 

attestations of citizenship status, 

verification of SSN, and QC data. 

6. For individuals seeking an 

exemption, CMS will provide last name, 

first name, date of birth, citizenship 

indicator, and SSN to SSA. SSA will 

provide CMS with a response including: 

Last name, first name, date of birth, 

confirmation of attestations of 

citizenship status, verification of SSN, 

death indicator, disability indicator, 

prisoner information, and Title II 

(annual and monthly) income 

information. 

SYSTEM(S) OF RECORDS: 

The records used in this matching 

program are disclosed from the 

following systems of records, as 

authorized by routine uses published in 

the System of Records Notices (SORNs) 

cited below: 

CMS System of Records: 

b The CMS SOR that supports this 

matching program is the ‘‘CMS Health 

Insurance Exchanges System (HIX)’’, 

CMS System No. 09–70–0560, last 

published in full at 78 FR 63211 

(October 23, 2013), as amended at 83 FR 

6591 (February 14, 2018). 

SSA Systems of Records: 

b Master Files of SSN Holders and 

SSN Applications, 60–0058, 75 FR 

82121 (Dec. 29, 2010), as amended at 78 

FR 40542 (July 5, 2013), and 79 FR 8780 

(Feb. 13, 2014); 

b Prisoner Update Processing System 

(PUPS), 60–0269, 64 FR 11076 (Mar. 8, 

1999), as amended at 72 FR 69723 (Dec. 

10, 2007) and 78 FR 40542 (July 5, 

2013); 

b Master Beneficiary Record, 60– 

0090, 71 FR 1826 (Jan. 1, 2006), as 

amended at 72 FR 69723 (Dec. 10, 2007) 

and 78 FR 40542 (July 5, 2013); and 

b Earnings Recording and SelfEmployment Income System, 60–0059, 

71 FR 1819 (Jan. 11, 2006), as amended 

at 78 FR 40542 (July 5, 2013). 

[FR Doc. 2018–16821 Filed 8–6–18; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3366–PN] 

Medicare and Medicaid Programs: 

National Dialysis Accreditation 

Commission (NDAC) for Approval of 

its End Stage Renal Disease (ESRD) 

Facility Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services (CMS), HHS. 

ACTION: Notice with request for 

comment. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the National Dialysis 

Accreditation Commission (NDAC) for 

recognition as a national accrediting 

organization (AO) for End Stage Renal 

Disease (ESRD) Facilities that wish to 

participate in the Medicare or Medicaid 

programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on September 6, 2018. 

ADDRESSES: In commenting, refer to file 

code CMS–3366–PN. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3366–PN, P.O. Box 8010, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3366–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: Tara 

Lemons, (410) 786–3030, Monda 

Shaver, (410) 786–3410, or Marie 

Vasbinder, (410) 786–8665. 


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38698 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from an end-stage renal disease 

(ESRD) facility provided the facility 

meets the requirements established by 

the Secretary of the Department of 

Health and Human Services (Secretary). 

Section 1881(b) of the Social Security 

Act (the Act) establishes distinct 

requirements for facilities seeking 

designation as an ESRD facility under 

Medicare. Regulations concerning 

provider agreements and supplier 

approval are at 42 CFR part 489 and 

those pertaining to activities relating to 

the survey, certification, and 

enforcement procedures of suppliers 

which include ESRD facilities are at 42 

CFR part 488. The regulations at 42 CFR 

part 494 subparts A through D 

implement section 1881(b) of the Act, 

which specify the conditions that an 

ESRD facility must meet in order to 

participate in the Medicare program and 

the conditions for Medicare payment for 

ESRD facilities. 

Generally, to enter into a Medicare 

agreement, an ESRD facility must first 

be certified by a State survey agency as 

complying with the conditions or 

requirements set forth in part 494 

subparts A through D of our Medicare 

regulations. Thereafter, the ESRD 

facility is subject to regular surveys by 

a State survey agency 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 may deem those provider 

entities as having met the requirements. 

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

historically prohibited dialysis facilities 

from participating in Medicare via a 

CMS-approved accreditation program; 

however, section 50403 of the 

Bipartisan Budget Act of 2018 amended 

section 1865(a) of the Act to include 

renal dialysis facilities as provider 

entities allowed to participate in 

Medicare through a CMS-approved 

accreditation program. Accreditation by 

an AO is voluntary and is not required 

for Medicare participation. 

If an AO is recognized by 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 

may be deemed to meet the Medicare 

conditions. An 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 

§ 488.5. 

II. Provisions of the Proposed Notice 

A. Approval of Deeming Organizations 

Section 1865(a)(2) of the Act and our 

regulations at § 488.5 require that our 

findings concerning review and 

approval of an AO’s requirements 

consider, among other factors, the 

applying AO’s requirements for 

accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and 

ability to provide CMS with the 

necessary data for validation. 

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

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accrediting 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from the receipt of a 

complete application to publish notice 

of approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of National 

Dialysis Accreditation Commission’s 

(NDAC) request for CMS-approval of its 

ESRD facility accreditation program. 

This notice also solicits public comment 

on whether NDAC’s requirements meet 

or exceed the Medicare conditions for 

coverage (CfCs) for ESRD facilities. 

This is the first application from a 

national accreditation body seeking 

approval of an accreditation program for 

ESRD facilities. 

B. Evaluation of Deeming Authority 

Request 

NDAC submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

CMS-approval of its ESRD facility 

accreditation program. This application 

was determined to be complete on June 

8, 2018. Under section 1865(a)(2) of the 

Act and our regulations at § 488.5, our 

review and evaluation of NDAC will be 

conducted in accordance with, but not 

necessarily limited to, the following 

factors: 

• The equivalency of NDAC’s 

standards for ESRD facilities as 

compared with Medicare’s CfCs for 

ESRD facilities. 

• NDAC’s survey process to 

determine the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of NDAC’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

++ NDAC’s processes and procedures 

for monitoring an ESRD facility found 

out of compliance with NDAC’s 

program requirements. These 

monitoring procedures are used only 

when NDAC identifies noncompliance. 

If noncompliance is identified through 

validation reviews or complaint 

surveys, the State survey agency 

monitors corrections as specified at 

§ 488.9(c)(1). 

++ NDAC’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ NDAC’s capacity to provide CMS 

with electronic data and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ The adequacy of NDAC’s staff and 

other resources, and its financial 

viability. 

++ NDAC’s capacity to adequately 

fund required surveys. 

++ NDAC’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ NDAC’s agreement to provide 

CMS with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as CMS may require (including 

corrective action plans). 


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Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38699 

III. 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.). 

IV. Response to Public Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a final notice in the Federal 

Register announcing the result of our 

evaluation. 

Dated: July 27, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–16871 Filed 8–6–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2382] 

Opioid Use Disorder: Endpoints for 

Demonstrating Effectiveness of Drugs 

for Medication-Assisted Treatment; 

Draft 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 draft 

guidance for industry entitled ‘‘Opioid 

Use Disorder: Endpoints for 

Demonstrating Effectiveness of Drugs for 

Medication-Assisted Treatment.’’ This 

guidance addresses the clinical 

endpoints acceptable to demonstrate 

effectiveness of drugs for medicationassisted treatment of opioid use 

disorder. FDA is also requesting 

comments on when the use of placebo 

or active controls is most appropriate in 

clinical trials for such drugs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 9, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2018–D–2382 for ‘‘Opioid Use Disorder: 

Endpoints for Demonstrating 

Effectiveness of Drugs for MedicationAssisted Treatment.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Silvana Borges, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 3200, 


daltland on DSKBBV9HB2PROD with NOTICES