Medicare and Medicaid Programs; Application From DNV GL Healthcare USA Inc. for Initial CMS Approval of Its Psychiatric Hospital Accreditation Program, 45639-45640 [2020-16453]

Download as PDF Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3388–FN] Medicare and Medicaid Programs; Application From DNV GL Healthcare USA Inc. for Initial CMS Approval of Its Psychiatric Hospital Accreditation Program Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final notice. AGENCY: This final notice announces our decision to approve DNV GL Healthcare USA Inc. (DNV GL) for initial recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs. DATES: The decision announced in this final notice is effective July 30, 2020 through July 30, 2024. FOR FURTHER INFORMATION CONTACT: Joann Fitzell, (410) 786–4280. Lillian Williams, (410) 786–8636. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Under the Medicare program, eligible beneficiaries may receive covered services from a psychiatric hospital provided certain requirements established by the Secretary of the Department of Health and Human Services (the Secretary) are met. Section 1861(f) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as a psychiatric hospital under Medicare. Regulations concerning provider agreements and supplier approval 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 subparts A, B, C and E specify the minimum conditions that a psychiatric hospital must meet to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for psychiatric hospitals. Generally, to enter into a provider agreement with the Medicare program, a psychiatric hospital must first be certified by a state survey agency as complying with the conditions or requirements set forth in part 482 subpart A, B, C and E of Centers for Medicare & Medicaid Services (CMS) regulations. Thereafter, the psychiatric hospital is subject to regular surveys by a state survey agency to determine whether it continues to meet the Medicare requirements. VerDate Sep<11>2014 17:23 Jul 28, 2020 Jkt 250001 However, there is an alternative to surveys by state agencies. Section 1865(a)(1) of the Act states, if a provider entity demonstrates through accreditation by an approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may treat the provider entity as having met those conditions, that is, we may deem the provider entity as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation. If an AO is recognized by CMS 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. 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 § 488.5. The regulations at § 488.5(e)(2)(i) require the AO to reapply for continued approval of its accreditation program every 6 years or sooner as determined by CMS. II. Application Approval Process Section 1865(a)(2) of the Act and our regulations at § 488.5 require that 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 that were 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 provides a statutory timetable to ensure that our review of applications for CMSapproval of an accreditation program is conducted in a timely manner. The Act provides CMS 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, CMS 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 30day public comment period. At the end PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 45639 of the 210-day period, CMS must publish a notice in the Federal Register approving or denying the application. III. Provisions of the Proposed Notice On March 2, 2020 Federal Register (85 FR 12306), we published a proposed notice announcing DNV GL Healthcare USA Inc. (DNV GL) request for approval of its Medicare psychiatric hospital accreditation program. In the 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 DNV GL’s Medicare psychiatric hospital accreditation application in accordance with the criteria specified by our regulations, which include, but are not limited to the following: • An onsite administrative review of DNV GL’s: (1) Corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring, and evaluation of its psychiatric hospital surveyors; (4) ability to investigate and respond appropriately to complaints against accredited psychiatric hospitals; and, (5) survey review and decisionmaking process for accreditation. • The comparison of DNV GL’s Medicare psychiatric hospital accreditation program standards to our current Medicare hospitals Conditions of Participation (CoPs) and psychiatric hospital special CoPs. • A documentation review of DNV GL’s psychiatric hospital survey process to do the following: ++ Determine the composition of the survey team, surveyor qualifications, and DNV GL’s ability to provide continuing surveyor training. ++ Compare DNV GL’s processes to those we require of state survey agencies, including periodic re-survey and the ability to investigate and respond appropriately to complaints against accredited psychiatric hospitals. ++ Evaluate DNV GL’s procedures for monitoring psychiatric hospitals it has found to be out of compliance with DNV GL’s program requirements. (This pertains only to monitoring procedures when DNV GL identifies as noncompliance. If noncompliance is identified by a state survey agency through a validation survey, the state survey agency monitors corrections as specified at § 488.9(c)(1)). ++ Assess DNV GL’s ability to report deficiencies to the surveyed hospital and respond to the psychiatric hospital’s plan of correction in a timely manner. ++ Establish DNV GL’s ability to provide CMS with electronic data and reports necessary for effective validation E:\FR\FM\29JYN1.SGM 29JYN1 45640 Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / Notices and assessment of the organization’s survey process. ++ Determine the adequacy of DNV GL’s staff and other resources. ++ Confirm DNV GL’s ability to provide adequate funding for performing required surveys. ++ Confirm DNV GL’s policies with respect to surveys being unannounced. ++ Confirm DNV GL’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 DNV GL’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. ++ As authorized under § 488.8(h), CMS reserves the right to conduct onsite observations of accrediting organization’s operations at any time as part of the ongoing review and continuing oversight of an AO’s performance. In accordance with section 1865(a)(3)(A) of the Act, the March 2, 2020 proposed notice also solicited public comments regarding whether DNV GL’s requirements met or exceeded the Medicare CoPs for psychiatric hospitals. We received 4 comments in response to our proposed notice. We thank the commenters for their support. We agreed with the commenters that a new psychiatric hospital accreditation organization would provide hospitals further options in regards to accreditation. Based on our comprehensive review of their program, we have approved DNV GL as such a program. IV. Provisions of the Final Notice A. Differences Between DNV GL’s Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements We compared DNV GL’s psychiatric hospital accreditation program requirements and survey process with the Medicare CoPs at 42 CFR part 482, and the survey and certification process requirements of parts 488 and 489. Our review and evaluation of DNV GL’s psychiatric hospital application, which were conducted as described in section III of this final notice, yielded the following areas where, as of the date of this notice, DNV GL has revised its standards and certification processes in order to meet the requirements at: • Section 482.41(c)(1): DNV GL revised its standards to not require the hospitals to adopt Chapters 7, 8, 12, and VerDate Sep<11>2014 17:23 Jul 28, 2020 Jkt 250001 13 of the adopted Health Care Facilities Code. • Section 482.61(a) through (a)(3): DNV GL revised its standards to require a diagnosis for all patients. • Section 482.61(b): DNV GL revised its standards to require a record of mental status. • State Operations Manual Chapter 3 Section 3012: DNV GL revised its materials to reflect its timeframe(s) for follow-up activities, including followup surveys for facilities that have previously demonstrated noncompliance at the condition level. • Section 488.5(a)(12): DNV GL revised its policies to ensure a clearly defined complaint investigation process is in place that meets the requirements in the State Operations Manual Chapter 5 Section 5010 and Chapter 5 Section 5075.2 that includes the following: ++ Complete and accurate tracking of complaints as well as a process for maintaining a documented record of contacts made (for example, phone, email and United States mail) with the complainant, and others, if applicable. ++ Defining the number of contact attempts required before closing out a complaint if the complainant does not respond. ++ Educating DNV GL complaint intake staff that when complaint allegations could potentially result in condition-level non-compliance affecting the health and safety of patients, a survey is to be considered regardless if the allegation also involves payment related allegations. ++ Investigating complaints onsite within an appropriate timeframe. B. Term of Approval Based on our review and observations described in section III of this final notice, we have determined that DNV GL’s psychiatric hospital accreditation program requirements meet or exceed our requirements, and its survey processes are also comparable. Therefore, we approve DNV GL as a national AO for psychiatric hospitals that request participation in the Medicare program, effective July 30, 2020 through July 30, 2024. V. 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.). PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 The Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: July 24, 2020. Lynette Wilson, Federal Register Liaison, Department of Health and Human Services. [FR Doc. 2020–16453 Filed 7–28–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1339] Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff.’’ This final guidance provides FDA’s regulatory approach for device products with multiple functions including at least one device function and includes such device products that are part of combination products, in accordance with the 21st Century Cures Act (Cures Act). DATES: The announcement of the guidance is published in the Federal Register on July 29, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: 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 E:\FR\FM\29JYN1.SGM 29JYN1

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[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Pages 45639-45640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16453]



[[Page 45639]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3388-FN]


Medicare and Medicaid Programs; Application From DNV GL 
Healthcare USA Inc. for Initial CMS Approval of Its Psychiatric 
Hospital Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: This final notice announces our decision to approve DNV GL 
Healthcare USA Inc. (DNV GL) for initial recognition as a national 
accrediting organization for psychiatric hospitals that wish to 
participate in the Medicare or Medicaid programs.

DATES: The decision announced in this final notice is effective July 
30, 2020 through July 30, 2024.

FOR FURTHER INFORMATION CONTACT:  Joann Fitzell, (410) 786-4280. 
Lillian Williams, (410) 786-8636.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a psychiatric hospital provided certain 
requirements established by the Secretary of the Department of Health 
and Human Services (the Secretary) are met. Section 1861(f) of the 
Social Security Act (the Act) establishes distinct criteria for 
facilities seeking designation as a psychiatric hospital under 
Medicare. Regulations concerning provider agreements and supplier 
approval 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 subparts A, B, C and E 
specify the minimum conditions that a psychiatric hospital must meet to 
participate in the Medicare program, the scope of covered services and 
the conditions for Medicare payment for psychiatric hospitals.
    Generally, to enter into a provider agreement with the Medicare 
program, a psychiatric hospital must first be certified by a state 
survey agency as complying with the conditions or requirements set 
forth in part 482 subpart A, B, C and E of Centers for Medicare & 
Medicaid Services (CMS) regulations. Thereafter, the psychiatric 
hospital is subject to regular surveys by a state survey agency to 
determine whether it continues to meet the Medicare requirements.
    However, there is an alternative to surveys by state agencies. 
Section 1865(a)(1) of the Act states, if a provider entity demonstrates 
through accreditation by an approved national accrediting organization 
(AO) that all applicable Medicare conditions are met or exceeded, we 
may treat the provider entity as having met those conditions, that is, 
we may deem the provider entity as having met the requirements. 
Accreditation by an AO is voluntary and is not required for Medicare 
participation.
    If an AO is recognized by CMS 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. 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 Sec.  488.5. The regulations at Sec.  
488.5(e)(2)(i) require the AO to reapply for continued approval of its 
accreditation program every 6 years or sooner as determined by CMS.

II. Application Approval Process

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that 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 
that were 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 provides a statutory timetable to 
ensure that our review of applications for CMS-approval of an 
accreditation program is conducted in a timely manner. The Act provides 
CMS 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, CMS 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, CMS must 
publish a notice in the Federal Register approving or denying the 
application.

III. Provisions of the Proposed Notice

    On March 2, 2020 Federal Register (85 FR 12306), we published a 
proposed notice announcing DNV GL Healthcare USA Inc. (DNV GL) request 
for approval of its Medicare psychiatric hospital accreditation 
program. In the proposed notice, we detailed our evaluation criteria. 
Under section 1865(a)(2) of the Act and in our regulations at Sec.  
488.5, we conducted a review of DNV GL's Medicare psychiatric hospital 
accreditation application in accordance with the criteria specified by 
our regulations, which include, but are not limited to the following:
     An onsite administrative review of DNV GL's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its psychiatric hospital surveyors; (4) ability to 
investigate and respond appropriately to complaints against accredited 
psychiatric hospitals; and, (5) survey review and decision-making 
process for accreditation.
     The comparison of DNV GL's Medicare psychiatric hospital 
accreditation program standards to our current Medicare hospitals 
Conditions of Participation (CoPs) and psychiatric hospital special 
CoPs.
     A documentation review of DNV GL's psychiatric hospital 
survey process to do the following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and DNV GL's ability to provide continuing surveyor 
training.
    ++ Compare DNV GL's processes to those we require of state survey 
agencies, including periodic re-survey and the ability to investigate 
and respond appropriately to complaints against accredited psychiatric 
hospitals.
    ++ Evaluate DNV GL's procedures for monitoring psychiatric 
hospitals it has found to be out of compliance with DNV GL's program 
requirements. (This pertains only to monitoring procedures when DNV GL 
identifies as non-compliance. If noncompliance is identified by a state 
survey agency through a validation survey, the state survey agency 
monitors corrections as specified at Sec.  488.9(c)(1)).
    ++ Assess DNV GL's ability to report deficiencies to the surveyed 
hospital and respond to the psychiatric hospital's plan of correction 
in a timely manner.
    ++ Establish DNV GL's ability to provide CMS with electronic data 
and reports necessary for effective validation

[[Page 45640]]

and assessment of the organization's survey process.
    ++ Determine the adequacy of DNV GL's staff and other resources.
    ++ Confirm DNV GL's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm DNV GL's policies with respect to surveys being 
unannounced.
    ++ Confirm DNV GL'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 DNV GL'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.
    ++ As authorized under Sec.  488.8(h), CMS reserves the right to 
conduct onsite observations of accrediting organization's operations at 
any time as part of the ongoing review and continuing oversight of an 
AO's performance.
    In accordance with section 1865(a)(3)(A) of the Act, the March 2, 
2020 proposed notice also solicited public comments regarding whether 
DNV GL's requirements met or exceeded the Medicare CoPs for psychiatric 
hospitals. We received 4 comments in response to our proposed notice. 
We thank the commenters for their support. We agreed with the 
commenters that a new psychiatric hospital accreditation organization 
would provide hospitals further options in regards to accreditation. 
Based on our comprehensive review of their program, we have approved 
DNV GL as such a program.

IV. Provisions of the Final Notice

A. Differences Between DNV GL's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared DNV GL's psychiatric hospital accreditation program 
requirements and survey process with the Medicare CoPs at 42 CFR part 
482, and the survey and certification process requirements of parts 488 
and 489. Our review and evaluation of DNV GL's psychiatric hospital 
application, which were conducted as described in section III of this 
final notice, yielded the following areas where, as of the date of this 
notice, DNV GL has revised its standards and certification processes in 
order to meet the requirements at:
     Section 482.41(c)(1): DNV GL revised its standards to not 
require the hospitals to adopt Chapters 7, 8, 12, and 13 of the adopted 
Health Care Facilities Code.
     Section 482.61(a) through (a)(3): DNV GL revised its 
standards to require a diagnosis for all patients.
     Section 482.61(b): DNV GL revised its standards to require 
a record of mental status.
     State Operations Manual Chapter 3 Section 3012: DNV GL 
revised its materials to reflect its timeframe(s) for follow-up 
activities, including follow-up surveys for facilities that have 
previously demonstrated non-compliance at the condition level.
     Section 488.5(a)(12): DNV GL revised its policies to 
ensure a clearly defined complaint investigation process is in place 
that meets the requirements in the State Operations Manual Chapter 5 
Section 5010 and Chapter 5 Section 5075.2 that includes the following:
    ++ Complete and accurate tracking of complaints as well as a 
process for maintaining a documented record of contacts made (for 
example, phone, email and United States mail) with the complainant, and 
others, if applicable.
    ++ Defining the number of contact attempts required before closing 
out a complaint if the complainant does not respond.
    ++ Educating DNV GL complaint intake staff that when complaint 
allegations could potentially result in condition-level non-compliance 
affecting the health and safety of patients, a survey is to be 
considered regardless if the allegation also involves payment related 
allegations.
    ++ Investigating complaints onsite within an appropriate timeframe.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that DNV GL's psychiatric 
hospital accreditation program requirements meet or exceed our 
requirements, and its survey processes are also comparable. Therefore, 
we approve DNV GL as a national AO for psychiatric hospitals that 
request participation in the Medicare program, effective July 30, 2020 
through July 30, 2024.

V. 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), Seema Verma, having reviewed and approved this document, 
authorizes Lynette Wilson, who is the Federal Register Liaison, to 
electronically sign this document for purposes of publication in the 
Federal Register.

    Dated: July 24, 2020.
Lynette Wilson,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-16453 Filed 7-28-20; 8:45 am]
BILLING CODE 4120-01-P

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