83 FR 38697 - Medicare and Medicaid Programs: National Dialysis Accreditation Commission (NDAC) for Approval of its End Stage Renal Disease (ESRD) Facility Accreditation Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 152 (August 7, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 152 (August 7, 2018)
| Page Range | 38697-38699 | |
| FR Document | 2018-16871 |
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)] [Notices] [Pages 38697-38699] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16871] ----------------------------------------------------------------------- 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. [[Page 38698]] 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 Sec. 488.5. II. Provisions of the Proposed Notice A. Approval of Deeming Organizations Section 1865(a)(2) of the Act and our regulations at Sec. 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 Sec. 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 Sec. 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). [[Page 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
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program enables CMS to compare its SSN with a death indicator, disclose DEPARTMENT OF HEALTH AND
data to SSA data to confirm an Title II income information, and provide HUMAN SERVICES
applicant’s or other relevant the disability indicator.
individual’s identity, citizenship, status 5. For self-reported redeterminations, Centers for Medicare & Medicaid
as deceased or imprisoned, and Title II CMS will provide SSA with the Services
disability benefit quarters of coverage following: Updated or new information [CMS–3366–PN]
(QC) and monthly and annual income. reported by the enrollee or enrolled
The data is used by CMS to authenticate individual, last name, first name, date of Medicare and Medicaid Programs:
identity, determine eligibility, and birth, and SSN. Depending on CMS’ National Dialysis Accreditation
determine the amount of an advance request, SSA’s response will include Commission (NDAC) for Approval of
payment of the premium tax credit each of the following data elements that its End Stage Renal Disease (ESRD)
(APTC) or cost sharing reduction (CSR). are relevant and responsive to CMS’ Facility Accreditation Program
request: Last name, first name, date of
CATEGORIES OF INDIVIDUALS:
birth, death indicator, disability AGENCY: Centers for Medicare and
The categories of individuals whose indicator, prisoner information, Title II Medicaid Services (CMS), HHS.
information is involved in the matching (annual and monthly) income ACTION: Notice with request for
program are consumers who apply for information, and confirmation of new comment.
any of the following eligibility attestations of citizenship status,
determinations, and other relevant SUMMARY: This proposed notice
verification of SSN, and QC data. acknowledges the receipt of an
individuals (e.g., an applicant’s 6. For individuals seeking an
household members) who have application from the National Dialysis
exemption, CMS will provide last name, Accreditation Commission (NDAC) for
eligibility to enroll in a qualified health first name, date of birth, citizenship
plan through an exchange established recognition as a national accrediting
indicator, and SSN to SSA. SSA will organization (AO) for End Stage Renal
under the ACA, eligibility for insurance provide CMS with a response including:
affordability programs and certificates of Disease (ESRD) Facilities that wish to
Last name, first name, date of birth, participate in the Medicare or Medicaid
exemption, and subsequent eligibility confirmation of attestations of
redeterminations and renewals, programs.
citizenship status, verification of SSN, DATES: To be assured consideration,
including appeal determinations. death indicator, disability indicator, comments must be received at one of
CATEGORIES OF RECORDS: prisoner information, and Title II the addresses provided below, no later
The categories of records used in the (annual and monthly) income than 5 p.m. on September 6, 2018.
matching program are identity, information.
ADDRESSES: In commenting, refer to file
citizenship, birth, death, disability SYSTEM(S) OF RECORDS: code CMS–3366–PN. Because of staff
coverage and income, and The records used in this matching and resource limitations, we cannot
imprisonment status records. The data program are disclosed from the accept comments by facsimile (FAX)
elements are as follows: following systems of records, as transmission.
1. For each applicant and for relevant Comments, including mass comment
authorized by routine uses published in
individuals, CMS will submit a request submissions, must be submitted in one
the System of Records Notices (SORNs)
file to SSA that contains the following of the following three ways (please
cited below:
mandatory specified data elements in a choose only one of the ways listed):
CMS System of Records:
fixed record format: Last name, first 1. Electronically. You may submit
b The CMS SOR that supports this
name, date of birth, social security electronic comments on this regulation
matching program is the ‘‘CMS Health
number (SSN), and citizenship to http://www.regulations.gov. Follow
Insurance Exchanges System (HIX)’’,
indicator. the ‘‘Submit a comment’’ instructions.
2. For each applicant, SSA will CMS System No. 09–70–0560, last
2. By regular mail. You may mail
provide CMS with a response file in a published in full at 78 FR 63211
written comments to the following
fixed record format. Depending on CMS’ (October 23, 2013), as amended at 83 FR
address ONLY: Centers for Medicare &
request, SSA’s response may include the 6591 (February 14, 2018).
Medicaid Services, Department of
following data elements: Last name, first SSA Systems of Records: Health and Human Services, Attention:
name, date of birth, death indicator, b Master Files of SSN Holders and CMS–3366–PN, P.O. Box 8010,
disability indicator, prisoner SSN Applications, 60–0058, 75 FR Baltimore, MD 21244–8010.
information, Title II (annual and 82121 (Dec. 29, 2010), as amended at 78 Please allow sufficient time for mailed
monthly) income information, and FR 40542 (July 5, 2013), and 79 FR 8780 comments to be received before the
confirmation of attestations of (Feb. 13, 2014); close of the comment period.
citizenship status and SSN. SSA may b Prisoner Update Processing System 3. By express or overnight mail. You
also provide QC data when CMS (PUPS), 60–0269, 64 FR 11076 (Mar. 8, may send written comments to the
requests it. 1999), as amended at 72 FR 69723 (Dec. following address ONLY: Centers for
3. For relevant individuals, CMS will 10, 2007) and 78 FR 40542 (July 5, Medicare & Medicaid Services,
request a limited amount of SSA 2013); Department of Health and Human
information. Based on CMS’ request, b Master Beneficiary Record, 60– Services, Attention: CMS–3366–PN,
SSA will verify a relevant individual’s 0090, 71 FR 1826 (Jan. 1, 2006), as Mail Stop C4–26–05, 7500 Security
SSN with a death indicator and may amended at 72 FR 69723 (Dec. 10, 2007) Boulevard, Baltimore, MD 21244–1850.
daltland on DSKBBV9HB2PROD with NOTICES
provide a relevant individual’s QC data and 78 FR 40542 (July 5, 2013); and For information on viewing public
or Title II (annual and monthly) income b Earnings Recording and Self- comments, see the beginning of the
information. CMS will not request Employment Income System, 60–0059, SUPPLEMENTARY INFORMATION section.
citizenship or immigration status data 71 FR 1819 (Jan. 11, 2006), as amended FOR FURTHER INFORMATION CONTACT: Tara
for a relevant individual. at 78 FR 40542 (July 5, 2013). Lemons, (410) 786–3030, Monda
4. For renewals and redeterminations, [FR Doc. 2018–16821 Filed 8–6–18; 8:45 am] Shaver, (410) 786–3410, or Marie
CMS will request and SSA will verify BILLING CODE 4120–03–P Vasbinder, (410) 786–8665.
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III. Collection of Information DATES: Submit either electronic or • Confidential Submissions—To
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This document does not impose by October 9, 2018 to ensure that the information that you do not wish to be
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that is, reporting, recordkeeping or draft guidance before it begins work on comments only as a written/paper
third-party disclosure requirements. the final version of the guidance. submission. You should submit two
Consequently, there is no need for ADDRESSES: You may submit comments copies total. One copy will include the
review by the Office of Management and on any guidance at any time as follows: information you claim to be confidential
Budget under the authority of the with a heading or cover note that states
Electronic Submissions
Paperwork Reduction Act of 1995 (44 ‘‘THIS DOCUMENT CONTAINS
U.S.C. 3501 et seq.). Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
IV. Response to Public Comments • Federal eRulemaking Portal: the claimed confidential information, in
Because of the large number of public https://www.regulations.gov. Follow the its consideration of comments. The
comments we normally receive on instructions for submitting comments. second copy, which will have the
Federal Register documents, we are not Comments submitted electronically, claimed confidential information
able to acknowledge or respond to them including attachments, to https:// redacted/blacked out, will be available
individually. We will consider all www.regulations.gov will be posted to for public viewing and posted on
comments we receive by the date and the docket unchanged. Because your https://www.regulations.gov. Submit
time specified in the DATES section of comment will be made public, you are both copies to the Dockets Management
this preamble, and, when we proceed solely responsible for ensuring that your Staff. If you do not wish your name and
with a subsequent document, we will comment does not include any contact information to be made publicly
respond to the comments in the confidential information that you or a available, you can provide this
preamble to that document. third party may not wish to be posted, information on the cover sheet and not
Upon completion of our evaluation, such as medical information, your or in the body of your comments and you
including evaluation of comments anyone else’s Social Security number, or must identify this information as
received as a result of this notice, we confidential business information, such ‘‘confidential.’’ Any information marked
will publish a final notice in the Federal as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Register announcing the result of our that if you include your name, contact except in accordance with 21 CFR 10.20
evaluation. information, or other information that and other applicable disclosure law. For
Dated: July 27, 2018. identifies you in the body of your more information about FDA’s posting
Seema Verma,
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
Administrator, Centers for Medicare & • If you want to submit a comment
Medicaid Services. the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
[FR Doc. 2018–16871 Filed 8–6–18; 8:45 am]
do not wish to be made available to the 23389.pdf.
BILLING CODE 4120–01–P
public, submit the comment as a
written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
DEPARTMENT OF HEALTH AND electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’).
HUMAN SERVICES received, go to https://
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[Docket No. FDA–2018–D–2382] follows: heading of this document, into the
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Document Created: 2018-11-06 10:39:00
Document Modified: 2018-11-06 10:39:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with request for comment. | |
| Dates | To be assured consideration, comments must be received at one of | |
| Contact | Tara Lemons, (410) 786-3030, Monda Shaver, (410) 786-3410, or Marie Vasbinder, (410) 786-8665. | |
| FR Citation | 83 FR 38697 |
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