69482 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

at 42 CFR part 485, subpart H specify 

the minimum conditions that an OPT 

must meet to participate in the Medicare 

program. 

Generally, to enter into an agreement, 

an OPT must first be certified by a state 

survey agency as complying with the 

conditions or requirements set forth in 

part 485, subpart H of our Medicare 

regulations. Thereafter, the OPT is 

subject to regular surveys by a state 

survey agency to determine whether it 

continues to meet these requirements. 

There is an alternative, however, to 

surveys by state agencies. 

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

that, if a provider entity demonstrates 

through accreditation by a CMSapproved national accrediting 

organization that all applicable 

Medicare conditions are met or 

exceeded, we may deem those provider 

entities as having met the requirements. 

Accreditation by an accrediting 

organization is voluntary and is not 

required for Medicare participation. 

If an accrediting organization 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 may be deemed to meet the 

Medicare conditions. A national 

accrediting organization applying for 

approval of its accreditation program 

under part 488, subpart A, must provide 

CMS with reasonable assurance that the 

accrediting organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the approval 

of accrediting organizations are set forth 

at § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require 

accrediting organizations to reapply for 

continued approval of its accreditation 

program every 6 years or sooner as 

determined by CMS. 

The American Association for 

Accreditation of Ambulatory Surgery 

Facilities (AAAASF’s) current term of 

approval for their OPT accreditation 

program expires April 22, 2015. 

II. Approval of Deeming Organizations 

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

regulations at § 488.8(a) require that our 

findings concerning review and 

approval of a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’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 us 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 AAAASF’s 

request for continued approval of its 

OPT accreditation program. This notice 

also solicits public comment on whether 

AAAASF’s requirements meet or exceed 

the Medicare conditions of participation 

(CoPs) for OPTs. 

III. Evaluation of Deeming Authority 

Request 

AAAASF submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued approval of its OPT 

accreditation program. This application 

was determined to be complete on 

September 29, 2014. Under Section 

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

at § 488.8 (Federal review of accrediting 

organizations), our review and 

evaluation of AAAASF will be 

conducted in accordance with, but not 

necessarily limited to, the following 

factors: 

• The equivalency of AAAASF’s 

standards for OPTs as compared with 

Medicare’s OPT CoPs. 

• AAAASF’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 AAAASF’s 

processes to those of state agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

—AAAASF’s processes and procedures 

for monitoring a OPT found out of 

compliance with AAAASF’s program 

requirements. These monitoring 

procedures are used only when 

AAAASF identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the state survey agency 

monitors corrections as specified at 

§ 488.7(d). 

—AAAASF’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

—AAAASF’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 AAAASF’s staff and 

other resources, and its financial 

viability. 

—AAAASF’s capacity to adequately 

fund required surveys. 

—AAAASF’s policies to assure that 

surveys are unannounced. 

—AAAASF’s agreement to provide CMS 

with a copy of the most current 

accreditation survey together with any 

other information related to the 

survey that CMS may request 

(including corrective action plans). 

IV. 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. 

V. 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. 

Dated: November 5, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–27649 Filed 11–20–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3301–FN] 

Medicare and Medicaid Programs; 

Continued Approval of DNV GL— 

Healthcare (DNV GL) Critical Access 

Hospital (CAH) Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 69483 

1Formerly known as Det Norske Veritas 

Healthcare, Inc. (DNVHC). 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve DNV GL— 

Healthcare (DNV GL) 1 for continued 

recognition as a national accrediting 

organization (AO) for critical access 

hospitals (CAH) that wish to participate 

in the Medicare or Medicaid programs. 

DATES: This final notice is effective 

December 23, 2014 through December 

23, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Barbara Easterling, (410) 786–0482, 

Lillian Williams, 410–786–8636, Cindy 

Melanson, (410) 786–0310, or Patricia 

Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a Critical Access Hospital 

(CAH) provided certain requirements 

are met. Sections 1820(c)(2)B, 1820(e) 

and 1861(mm)(1) of the Social Security 

Act (the Act) establish distinct criteria 

for facilities seeking designation as a 

CAH. 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 485, subpart F, specify 

the conditions that a CAH must meet to 

participate in the Medicare program, the 

scope of covered services, and the 

conditions for Medicare payment for 

CAHs. 

Generally, to enter into an agreement, 

a CAH must first be certified by a state 

survey agency as complying with the 

conditions or requirements set forth in 

part 485, subpart F. Thereafter, the CAH 

is subject to regular surveys by a state 

survey agency to determine whether it 

continues to meet these requirements. 

However, there is an alternative to 

surveys by state agencies. Certification 

by a nationally recognized accreditation 

program can substitute for ongoing state 

review. 

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

that, if a provider entity demonstrates 

through accreditation by an 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 accrediting organization is 

recognized by the Secretary of the 

Department of Health and Human 

Services 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 

us 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 

and § 488.8(d)(3). The regulations at 

§ 488.8(d)(3) require an AO to reapply 

for continued approval of its 

accreditation program every 6 years or 

sooner as determined by us. The DNV 

GL’s current term of approval for their 

CAH accreditation program expires 

December 23, 2014. 

II. Application Approval Process 

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 us with 210 calendar 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 June 27, 2014, we published a 

proposed notice in the Federal Register 

(79 FR 36521) announcing DNV GL’s 

request for approval of its CAH 

accreditation program. In the proposed 

notice, we detailed our evaluation 

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

Act and in our regulations at § 488.4 and 

§ 488.8, we conducted a review of DNV 

GL’s 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 surveyors; (4) ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

and, (5) survey review and decisionmaking process for accreditation. 

• The comparison of DNV GL’s 

accreditation to our current Medicare 

CAH conditions of participation (CoPs). 

• A documentation review of DNV 

GL’s survey process to: 

++ 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 of state survey agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities. 

++ Evaluate DNV GL’s procedures for 

monitoring CAHs out of compliance 

with DNV GL’s program requirements. 

The monitoring procedures are used 

only when DNV GL identifies 

noncompliance. If noncompliance is 

identified through validation reviews, 

the state survey agency monitors 

corrections as specified at § 488.7(d). 

++ Assess DNV GL’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ Establish DNV GL’s ability to 

provide us with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

++ Determine the adequacy of 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 whether surveys are 

announced or unannounced. 

++ Obtain DNV GL’s agreement to 

provide us 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. 

In accordance with section 

1865(a)(3)(A) of the Act, the June 27, 

2014 proposed notice also solicited 

public comments regarding whether 

DNV GL’s requirements met or exceeded 

the Medicare conditions of participation 

for CAHs. We received no comments in 

response to our proposed notice. 

IV. Provisions of the Final Notice 

A. Differences Between DNV GL’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared DNV GL’s CAH 

requirements and survey process with 

the Medicare conditions of participation 

and survey process as outlined in the 

State Operations Manual (SOM). Our 

review and evaluation of DNV GL’s 

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69484 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

CAH accreditation program application, 

which were conducted as described in 

section III of this final notice, yielded 

the following: 

• To meet the requirements at 

§ 412.25(d), DNV GL revised its 

standards to address the number of 

excluded units permitted. 

• To meet the requirements at 

§ 412.27(c)(2)(vii), DNV GL revised its 

standards to include the requirement for 

an inventory of the inpatient’s assets in 

a descriptive fashion and ensured that 

consistent language is used in the 

crosswalk and manual. 

• To meet the requirements at 

§ 412.27(d)(3), DNV GL revised its 

standards to more fully address nursing 

services requirements. 

• To meet the requirements 

§ 412.27(d)(4), DNV GL revised its 

standards to address ‘‘service 

objectives’’ for psychological services. 

• To meet the requirements at 

§ 412.27(d)(6)(ii), DNV GL revised its 

standards to address the number of 

‘‘qualified therapists, support personnel 

and consultants’’ needed to provide 

comprehensive therapeutic activities 

consistent with each inpatient’s active 

treatment program. 

• To meet the requirements at 

§ 412.29(h), DNV GL revised its 

standards to ensure a plan of treatment 

for each inpatient that is established, 

reviewed, and revised as needed by a 

physician in consultation with other 

professional personnel who provide 

services to the patient. 

• To meet the requirements at 

§ 482.12(c)(1)(iv), DNV GL revised its 

standards related to a doctor of 

optometry. 

• To meet the requirements at 

§ 482.12(c)(2), DNV GL revised its 

standards to address the regulatory 

language, ‘‘patients are admitted to the 

hospital only on the recommendation of 

a licensed practitioner.’’ 

• To meet the requirements at 

§ 482.13(h)(1), DNV GL revised its 

standards to more fully address the 

requirement to inform each patient (or 

‘‘support person, where appropriate’’) of 

his or her visitation rights, including 

any clinical restriction or limitation on 

such rights, when he or she is informed 

of his or her rights under this section, 

and ensured consistent language is used 

in its manual and crosswalk. 

• To meet the requirements at 

§ 482.21(e)(1), DNV GL revised its 

standards to ensure that an ongoing 

quality assurance performance 

improvement program is ‘‘maintained.’’ 

• To meet the requirements at 

§ 482.22(c)(5)(i) through (ii), DNV GL 

revised its standards to ensure that a 

medical history and physical is 

conducted, completed, and updated in 

accordance with ‘‘hospital policy.’’ 

• To meet the requirements at 

§ 482.25(b)(2)(i), DNV GL revised its 

crosswalk to address the requirement 

that all drugs and biologicals must be 

kept in a secure area, and locked when 

appropriate. 

• To meet the requirements at 

§ 482.27(b)(3)(i), DNV GL revised its 

standards to more fully address the 

regulatory language related to HIV 

testing of blood and blood components 

from a blood donor who tested negative 

at the time of donation, but tests 

reactive for evidence of HIV or HCV 

infection on a later donation, ‘‘or who 

is at increased risk for transmitting HIV 

or HCV infection.’’ 

• To meet the requirements at 

§ 482.30(f), DNV GL revised its 

crosswalk to address review of 

professional services. 

• To meet the requirements at 

§ 482.41(b)(6), DNV GL revised its 

standards to include a requirement for 

the proper routine storage and prompt 

disposal of all trash. 

• To meet the requirements at 

§ 482.41(b)(7), DNV GL revised its 

standards to address the evacuation and 

relocation plan requirement, periodic 

instruction for employees and a readily 

available plan in the telephone 

operator’s position at the security 

center. 

• To meet the requirements at 

§ 483.12(a)(8), DNV GL revised its 

standards to address written advance 

notice of facility closure. 

• To meet the requirements at 

§ 483.15(f)(2)(i), DNV GL revised its 

standards to address this requirement 

for a qualified therapeutic recreational 

specialist or an activities professional. 

• To meet the requirements at 

§ 483.15(f)(2)(i), DNV GL revised its 

standards to include standards requiring 

a qualified therapeutic recreation 

specialist. 

• To meet the requirements at 

§ 483.55(a)(1), DNV GL revised its 

standards to address the requirement 

that the facility provide or obtain from 

an outside resource, routine and 

emergency dental services to meet the 

needs of each resident. 

• To meet the requirements at 

§ 485.604(c)(3), DNV GL revised its 

standards to include the requirement 

that physician assistants must have been 

assisting primary care physicians for a 

total of 12 months during the 18-month 

period immediately preceding June 25, 

1993. 

• To meet the requirements at 

§ 485.604(b)(3), DNV GL revised its 

standards and crosswalk to address the 

requirement that the nurse practitioner 

must have ‘‘been performing an 

expanded role in the delivery of primary 

care for a total of 12 months during the 

18-month period immediately preceding 

June 25, 1993.’’ 

• To meet the requirements at 

§ 485.604(c)(2)(ii), DNV GL revised its 

standards to more fully address 

physician assistant supervised clinical 

practice and classroom instruction 

program requirements. 

• To meet the requirements at 

§ 485.606, DNV GL revised its 

referenced standard and crosswalk to 

address how DNV GL determines that 

the appropriate CAH designations and 

certifications have been made by CMS 

and/or the state agency. 

• To meet the requirements at 

§ 485.608, DNV GL revised its standards 

to include compliance with federal, 

state and local CAH laws and 

regulations and to reconcile the 

inconsistent language between the 

manual and crosswalk. 

• To meet the requirements at 

§ 485.608(a), DNV GL revised its 

standards to address the requirement 

that the CAH must be licensed in 

accordance with federal ‘‘regulations.’’ 

• To meet the requirements at 

§ 485.608(b), DNV GL revised its 

standards and crosswalk to address the 

requirement that all patient services are 

furnished in accordance with applicable 

‘‘local’’ laws, and to address furnishing 

patient care services in accordance with 

state and local ‘‘regulations.’’ 

• To meet the requirements at 

§ 485.608(c), DNV GL revised its 

standards to address the requirement 

that the CAH is licensed in accordance 

with applicable federal, state, and local 

‘‘regulations.’’ 

• To meet the requirements at 

§ 485.608(d), DNV GL revised its 

standards to address the requirement 

that staff of the CAH are ‘‘licensed, 

certified, or registered in accordance 

with applicable federal, state, and local 

regulations.’’ 

• To meet the requirements at 

§ 485.612, DNV GL revised its standards 

to ensure the facility is a hospital that 

has a provider agreement to participate 

in the Medicare program as a hospital at 

the time the hospital applies for 

designation as a CAH. 

• To meet the requirements at 

§ 485.616(a), DNV GL revised its 

standards and crosswalk to address 

agreements with network hospitals. 

• To meet the requirements at 

§ 485.616(b), DNV GL revised its 

standards and crosswalk to address 

agreements for credentialing and quality 

assurance. 

• To meet the requirements at 

§ 485.616(c) through (c)(1)(ii), DNV GL 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 69485 

revised its standards to address 

agreements for credentialing and 

privileging of telemedicine physicians 

and practitioners. 

• To meet the requirements at 

§ 485.616(c)(2)(iv), DNV GL updated 

their Medicare cross-walk to include 

standards to address when telemedicine 

services are provided to the CAH’s 

patients through an agreement with a 

distant site hospital, the CAH’s 

governing body or responsible 

individual may choose to rely upon the 

credentialing and privileging decisions 

of the distant site hospital. 

• To meet the requirements at 

§ 485.616(c)(3), DNV GL revised its 

standards to address the governing body 

of the CAH must ensure that 

telemedicine services are furnished in 

accordance with § 485.635(c)(4)(ii) and 

to ensure consistent language in its 

crosswalk. 

• To meet the requirements at 

§ 485.618(c), DNV GL revised its 

standards to address the requirement 

that the facility provide blood and blood 

products, either directly or under 

arrangement. 

• To meet the requirements at 

§ 485.618(c)(1), DNV GL revised its 

standards to address the requirement 

that the facility provide services for the 

procurement, safekeeping, and 

transfusion of blood, including the 

availability of blood products needed 

for emergencies on a 24-hour a day 

basis. 

• To meet the requirements at 

§ 485.618(c)(2), DNV GL revised its 

standards and crosswalk to address 

blood storage facilities. 

• To meet the requirements at 

§ 485.618(d)(1), DNV GL revised its 

standards to address personnel 

requirements and to ensure consistent 

language in its crosswalk. 

• To meet the requirements at 

§ 485.623, DNV GL revised its standards 

to address physical plant and 

environment and to ensure consistent 

language in its crosswalk. 

• To meet the requirements at 

§ 485.631(b)(1)(ii), DNV GL revised its 

standards to address written policies 

governing services the CAH furnishes. 

• To meet the requirements at 

§ 485.631(b)(1)(iii), DNV GL revised its 

standards to address the requirement for 

providing medical orders. 

• To meet the requirements at 

§ 485.631(b)(2), DNV GL revised its 

standards to address the requirement for 

providing medical care services. 

• To meet the requirements at 

§ 485.631(c)(1)(i), DNV GL revised its 

standards to address other CAH nonclinical written policies. 

• To meet the requirements at 

§ 485.635(a)(3)(ii), DNV GL revised its 

standards to address the requirement for 

emergency medical services policies 

and procedures. 

• To meet the requirements at 

§ 485.635(a)(3)(iii), DNV GL revised its 

standards to address ‘‘the maintenance 

of health care records.’’ 

• To meet the requirements at 

§ 485.635(a)(3)(iv), DNV GL revised its 

standards to address the requirement 

that current and accurate records are 

kept of the receipt and disposition of all 

scheduled drugs. 

• To meet the requirements at 

§ 485.635(b)(1)(ii), DNV GL revised its 

standards to clarify how their surveyors 

determine that a CAH furnishes acute 

care inpatient services when no 

inpatients are present at the time of the 

survey. 

• To meet the requirements at 

§ 485.635(d)(1), DNV GL revised its 

standards to clarify under what 

authority nursing services may be 

provided or supervised by a Physician 

Assistant (PA) where permitted by state 

law. 

• To meet the requirements at 

§ 485.635(d)(4), DNV GL revised its 

standards and crosswalk to fully address 

the requirement that a nursing care plan 

must be developed and kept current for 

each patient. 

• To meet the requirements at 

§ 485.638(a)(4), DNV GL revised its 

standards to more fully address the 

requirement that the CAH maintains a 

medical record for each patient 

receiving health care services. 

• To meet the requirements at 

§ 485.638(a)(4)(iii), DNV GL revised its 

standards to fully address the 

requirement that the medical record 

contains ‘‘reports of treatments and 

medications.’’ 

• To meet the requirements at 

§ 485.639(a), DNV GL revised its 

standards to fully address the 

requirement related to designation of 

qualified practitioners allowed to 

perform surgery ‘‘in accordance with 

approved policies and procedures, and 

with state scope of practice laws.’’ 

• To meet the requirements at 

§ 485.639(b)(2) and (b)(3), DNV GL 

revised its standards to address the 

requirement to specify a ‘‘qualified’’ 

practitioner examine each patient before 

surgery to evaluate the risk of 

anesthesia. 

• To meet the requirements at 

§ 485.641(b)(5)(i), DNV GL revised its 

standards to fully address the 

requirement that the CAH consider the 

findings of the evaluations, ‘‘including 

any findings or recommendations of the 

Quality Improvement Organization 

(QIO),’’ and takes corrective action if 

necessary. 

• To meet the requirements at 

§ 485.645, DNV GL revised its standards 

to explain how it would determine that 

we have granted approval for the CAH 

to provide and be paid for post-hospital 

SNF level care as specified in 42 CFR 

409.30. 

• To meet the requirements 

§ 488.28(a) and section 2728B of the 

State Operations Manual (SOM), DNV 

GL amended its policies to ensure that 

the accepted PoCs contains the elements 

comparable to those specified in the 

SOM, section 2728B. 

• To meet the requirements at § 488.6, 

DNV GL provided a written plan to 

address the components of the CAH 

application for Distinct Part Units 

(DPUs) and swing beds, and to ensure 

that the surveys consistently document 

evaluation of the CAH’s DPUs and 

swing beds, as applicable. 

• To meet the requirements at 

§ 488.8(a)(2)(iv), DNV GL developed an 

action plan designed to: Strengthen 

DNV GL surveyor documentation skills; 

consistently develop more detailed, 

quantifiable deficiency statements that 

contain all evidence collected by the 

survey team; and support the 

determination of the manner and degree 

of non-compliance and the appropriate 

level of citation. 

• To meet the requirements at 

§ 489.13(b), DNV GL revised its policy 

for determining the effective date of 

accreditation for an initial and reaccreditation survey. 

B. Term of Approval 

Based on our review and observations 

described in section IV of this final 

notice, we have determined that DNV 

GL’s CAH accreditation program 

requirements meet or exceed our 

requirements. Therefore, we approve 

DNV GL as a national accreditation 

organization for CAHs that request 

participation in the Medicare program, 

effective December 23, 2014 through 

December 23, 2020. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection, recordkeeping 

requirements or third party disclosure 

requirements. Consequently, it need not 

be reviewed by the Office of 

Management and Budget under the 

authority of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 35). 

mstockstill on DSK4VPTVN1PROD with NOTICES

69486 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

Dated: November 13, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–27576 Filed 11–20–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3297–FN] 

Medicare and Medicaid Programs: 

Continued Approval of The Joint 

Commission’s Ambulatory Surgical 

Center Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve The Joint 

Commission (TJC) for continued 

recognition as a national accrediting 

organization for ambulatory surgical 

centers (ASCs) that wish to participate 

in the Medicare or Medicaid programs. 

DATES: This final notice is effective 

December 20, 2014 through December 

20, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Monda Shaver (410) 786–3410, Cindy 

Melanson, (410) 786–0310, or Patricia 

Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A healthcare provider may enter into 

an agreement with Medicare to 

participate in the program as an 

Ambulatory Surgical Center (ASC) 

provided certain requirements are met. 

Section 1832(a)(2)(F)(i) of the Social 

Security Act (the Act) establishes 

criteria for providers seeking 

participation as an ASC. Regulations 

concerning Medicare provider 

agreements in general are at 42 CFR part 

489 and those pertaining to the survey 

and certification for Medicare 

participation of providers and certain 

types of suppliers are at 42 CFR part 

488. The regulations at 42 CFR part 416 

specify the specific conditions that a 

provider must meet to participate in the 

Medicare program as an ASC. 

Generally, to enter into a Medicare 

provider agreement, a facility must first 

be certified as complying with the 

conditions set forth in part 416 and 

recommended to CMS for participation 

by a State survey agency. Thereafter, the 

ASC is subject to periodic surveys by a 

State survey agency to determine 

whether it continues to meet these 

conditions. Accreditation by a 

nationally recognized Medicare 

accreditation program approved by CMS 

may substitute for both initial and 

ongoing State review. 

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

that, if the Secretary of the Department 

of Health and Human Services (the 

Secretary) finds that accreditation of a 

provider entity by an approved national 

accrediting organization meets or 

exceeds all applicable Medicare 

conditions, we may treat the provider 

entity as having met those conditions, 

that is, we may ‘‘deem’’ the provider 

entity to be in compliance. 

Accreditation by an accrediting 

organization is voluntary and is not 

required for Medicare participation. 

Part 488, subpart A, implements the 

provisions of section 1865 of the Act 

and requires that a national accrediting 

organization applying for approval of its 

Medicare accreditation program must 

provide us with reasonable assurance 

that the accrediting organization 

requires its accredited provider entities 

to meet requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the approval 

of accrediting organizations are set forth 

at § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require an 

accrediting organization to reapply for 

continued approval of its Medicare 

accreditation program every 6 years or 

sooner as as determined by CMS. The 

Joint Commission (TJC’s) current term of 

approval as a recognized Medicare 

accreditation program for ASCs expires 

December 20, 2014. 

II. Application Approval Process 

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 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 

In the June 27, 2014 Federal Register 

(79 FR 36522), we published a proposed 

notice announcing TJC’s request for 

continued approval of its Medicare ASC 

accreditation program. In the June 27, 

2014 proposed notice, we detailed our 

evaluation criteria. Under section 

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

regulations at § 488.4 and § 488.8, we 

conducted a review of TJC’s Medicare 

ASC 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 

TJC’s: (1) Corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its ASC surveyors; (4) 

ability to investigate and respond 

appropriately to complaints against 

accredited ASCs; and (5) survey review 

and decision-making process for 

accreditation. 

• The comparison of TJC’s Medicare 

accreditation program standards to our 

current Medicare ASC conditions for 

coverage (CfCs). 

• A documentation review of TJC’s 

survey process to— 

++ Determine the composition of the 

survey team, surveyor qualifications, 

and TJC’s ability to provide continuing 

surveyor training. 

++ Compare TJC’s processes to those 

CMS require of State survey agencies, 

including periodic resurvey and the 

ability to investigate and respond 

appropriately to complaints against 

accredited ASCs. 

++ Evaluate TJC’s procedures for 

monitoring ASCs found to be out of 

compliance with TJC’s program 

requirements. (This pertains only to 

monitoring procedures when TJC 

identifies non-compliance. If 

noncompliance is identified by a State 

survey agency through a validation 

survey, the State survey agency 

monitors corrections as specified at 

§ 488.7(d).) 

++ Assess TJC’s ability to report 

deficiencies to the surveyed ASCs and 

respond to the ASC’s plan of correction 

in a timely manner. 

++ Establish TJC’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 TJC’s 

staff and other resources. 

++ Confirm TJC’s ability to provide 

adequate funding for performing 

required surveys. 

++ Confirm TJC’s policies with 

respect to surveys being unannounced. 

++ Obtain TJC’s agreement to provide 

CMS with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

mstockstill on DSK4VPTVN1PROD with NOTICES