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 

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Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 69487 

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 

TJC’s requirements met or exceeded the 

Medicare CfCs for ASCs. We received no 

comments in response to our proposed 

notice. 

IV. Provisions of the Final Notice 

A. Differences Between TJC’s Standards 

and Requirements for Accreditation and 

Medicare Conditions and Survey 

Requirements 

We compared TJC’s ASC accreditation 

requirements and survey process with 

the Medicare CfCs of part 416, and the 

survey and certification process 

requirements of parts 488 and 489. Our 

review and evaluation of TJC’s ASC 

application was conducted as described 

in section III of this final notice. As of 

the date of this notice, TJC is in the 

process of or has completed revising its 

standards and certification processes in 

order to meet the following 

requirements: 

• Section 416.41, to address the 

ASC’s Governing Body’s responsibility 

for oversight and accountability for 

determining, implementing, and 

monitoring policies governing the ASC’s 

total operation. 

• Section 416.41(b)(1), to ensure the 

ASC is required to have an effective 

procedure for the immediate transfer to 

a hospital and patients requiring 

emergency medical care beyond the 

capabilities of the ASC. 

• Section 416.41(b)(2), to address the 

requirement that the hospital be a local, 

Medicare-participating hospital or a 

local, nonparticipating hospital that 

meets the requirements for payment for 

emergency services under § 482.2. 

• Section 416.41(b)(3)(i), to ensure 

the ASC has a written transfer 

agreement with a hospital that meets the 

requirements at § 416.41(b)(2). 

• Section 416.41(b)(3)(ii), to address 

the requirement that all physicians 

performing surgery in the ASC have 

admitting privileges at a hospital that 

meets the requirements at § 416.41(b)(2). 

• Section 416.42(c)(1) and 

§ 416.42(c)(2), to address State 

exemption from the requirement for 

physician supervision of a certified 

registered nurse anesthetist. 

• Section 416.43(a)(1), to address the 

requirement that the program 

demonstrate measurable improvements 

in health outcomes and improves 

patient safety by the identification and 

reduction of medical errors. 

• Section 416.43(c)(1)(ii), to address 

requirements related to the setting of 

priorities for ASC performance 

improvement activities. 

• Section 416.43(e)(1), to ensure the 

Governing Body takes responsibility and 

is involved in the operation of the ASCs 

[Quality Assessment Performance 

Improvement (QAPI) Program. 

• Section 416.43(e)(2), to include the 

requirement that the Governing Body is 

responsible for addressing the ASC’s 

priorities and that all improvements are 

evaluated for effectiveness. 

• Section 416.43(e)(4), to ensure that 

the ASC clearly establishes its 

expectations for safety. 

• Section 416.44(a), to ensure ASCs 

maintain equipment in accordance with 

manufacturer requirements or other 

Federal or State requirements. 

• Section 416.44(a)(1), to ensure 

operating rooms are designed and 

equipped so that the types of surgery 

conducted can be performed in a 

manner that protects the lives and 

assures the physical safety of all 

individuals in the area. 

• Section 416.44(b)(1), to include the 

provisions required under the 2000 

edition of the Life Safety Code of the 

National Fire Protection Association. 

• Section 416.44(b)(2), to address 

requirements related to life safety code 

waivers. 

• Section 416.44(c), to address the 

requirement that the ASC medical staff 

and governing body coordinate, develop 

and revise ASC policies and procedures 

to specify the types of emergency 

equipment required for use in the ASC’s 

operating room. 

• Section 416.45(c), to include a 

provision that should the ASC assigns 

patient care responsibilities to 

practitioners other than physicians, it 

must have established policies and 

procedures approved by the governing 

body for overseeing and evaluating their 

clinical activities. 

• Section 416.47(b), to address the 

timeframe within which the preoperative diagnostic studies must be 

present in the medical record. 

• Section 416.48(a), to address the 

preparation of drugs. 

• Section 416.49(a), to include the 

requirement that the ASC must have 

procedures for obtaining routine and 

emergency laboratory services from a 

certified laboratory when the ASC does 

not provide its own laboratory services. 

• Section 416.49(b)(2), to include the 

requirement that radiologic services 

must meet the hospital conditions of 

participation for radiologic services 

specified in § 482.26. 

• Section 416.50, to update the 

Medicare regulatory language on its 

standards crosswalk. 

• Section 416.50(c)(3), to address the 

requirement that the ASC document in 

a prominent part of the medical record 

whether or not the individual has 

executed an advance directive. 

• Section 416.50(g), to ensure the 

ASC complies with the Department of 

Health and Human Services (the 

Department) rules for the privacy and 

security of individually identifiable 

health information 

• Section 416.51(a), to ensure the 

ASC provides a functional and sanitary 

environment for the provision of 

surgical services by adhering to 

professionally acceptable standards of 

practice. 

• Section 416.51(b), to address the 

requirement that the ASC infection 

control and prevention program include 

documentation that the ASC has 

considered, selected, and implemented 

nationally recognized infection control 

program guidelines. 

• Section 416.52(b)(1), to address the 

requirement related to whom may 

document that the patient has met 

discharge criteria. 

• Section 416.52(c)(2), to address the 

requirement that each patient has a 

discharge order signed by the physician 

who performed the surgery or procedure 

in accordance with applicable State 

health and safety laws, standards of 

practice, and ASC policy. 

• Section 488.4(a)(4), to clarify the 

minimum composition of its survey 

team for its Medicare ASC accreditation 

program. 

• Section 488.4(a)(4)(ii) through (v), 

to ensure compliance with its own 

policies that require evidence that its 

surveyors are appropriately qualified, 

trained, and evaluated. 

• Section 488.4(a)(6), to ensure 

compliance with its own policies that 

require requests for a plan of correction 

(PoC) be timely, follow-up surveys for 

immediate threat to life (ITL) situations 

to be conducted timely, and that 

findings are accurately reported to CMS 

via the Accrediting Organization System 

for Storing User Recorded Experiences 

(ASSURE) database system. 

• Section 488.4(b)(3)(iii) and 

§ 488.8(d), to ensure CMS is notified of 

any proposed changes in its CMSapproved Medicare ASC accreditation 

program 30 days prior to 

implementation of such changes, and to 

confirm that it will not implement 

changes CMS have disapproved or 

required to be modified. 

• Section 488.8, to provide CMS with 

data that ensures the following 

information is accurately reported: the 

date of a complaint receipt; 

determination of complaints as 

substantiated or unsubstantiated; 

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69488 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

determinations of ITL situations; and 

surveyor documentation that includes a 

detailed deficiency statement that 

clearly supports the determination of 

manner and degree of non-compliance 

and the appropriate level of citation. 

• Section 488.8(a)(2)(iv), to 

strengthen surveyor documentation to 

include sufficient detail to support the 

determination of the manner and degree 

of non-compliance and the appropriate 

level of deficiency citation. 

• Section 489.13, related to the 

effective date of accreditation for 

facilities undergoing a survey for 

purposes of its initial participation in 

Medicare; to ensure the effective date of 

accreditation when deficiencies have 

been identified, and to ensure it is 

consistent with CMS regulatory 

requirements. 

• To ensure comparability with the 

survey process requirements at 

§ 488.26(d), TJC must have— 

++ Updated its accreditation process 

policies to clarify that all surveys for 

TJC’s Medicare ASC accreditation 

program are conducted unannounced. 

++ Updated its accreditation process 

policies to ensure all required follow-up 

surveys for its Medicare ASC 

accreditation program meet the 

Medicare requirements. 

++ Revised its accreditation process 

policies to clarify that the appropriate 

level of citation be made when an 

Immediate Threat to Health or Safety is 

identified. 

++ Clarified its survey policies in the 

surveyor activity guide (SAG) to address 

how ‘‘Special Issue Resolution’’ is 

handled during surveys lasting only 1 

day. 

++ Updated its ASC accreditation 

process policies to clearly demonstrate 

that the policies are related to ASCs and 

not hospitals. 

• Section 488.28(a), to include all 

documented observations of noncompliance and all internal, 

uncompleted Plans for Improvement 

(PFI) listed in the accredited ASC’s 

‘‘Statement of Condition (SOC) to 

correct Life Safety Code Deficiencies’’ 

into the survey report. In addition, TJC 

will provide CMS with rationale for 

each standard for which TJC has 

determined will not require a citation of 

non-compliance when a single 

observation has been made. 

• Complied with section 1861(e)(9)(C) 

of the Act, to require that waiver and 

equivalency requests submitted by 

accredited organizations for Life Safety 

Code deficiencies that would result in 

unreasonable hardship for such a 

facility to resolve and would not 

jeopardize patient health or safety, be 

reviewed by TJC, and forwarded to CMS 

for approval, as appropriate. 

• To demonstrate comparability with 

minimum eligibility requirements for 

Initial surveys, increased the minimum 

number of patients/volume of services 

from three patients served with one 

active at the time of survey, to ten 

patients served, with one active at the 

time of survey. 

• To comply with TJS’s own policies, 

TJS must— 

++ Ensure its surveyors complete the 

ASC Infection Control Worksheet on 

every survey. 

++ Ensure its surveyors observe at 

least one surgery during every survey. 

++ Ensure that the minimum number 

of medical records have been reviewed 

on every survey. 

++ Ensure that findings noted on the 

Infection Control Worksheet are 

integrated into the survey report 

findings. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we approve TJC as a national 

accreditation organization for ASCs that 

request participation in the Medicare 

program, effective December 20, 2014 

through December 20, 2020. 

To verify TJC’s continued compliance 

with the provisions of this final notice, 

we will conduct a follow-up corporate 

on-site visit and survey observation 

within 18 months of the date of 

publication of this final notice. 

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. Chapter 35). 

Dated: November 5, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–27577 Filed 11–20–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6064–N] 

Medicare Program; Prior Authorization 

of Non-Emergent Hyperbaric Oxygen 

(HBO) Therapy 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 3- 

year Medicare Prior Authorization 

model for non-emergent hyperbaric 

oxygen therapy services in the states of 

Illinois, Michigan, and New Jersey 

where there have been high incidences 

of improper payments for these services. 

DATES: The model will begin on March 

1, 2015 in Michigan, New Jersey, and 

Illinois. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer McMullen, (410) 786–7635. 

Questions regarding the Medicare 

Prior Authorization Model for NonEmergent Hyperbaric Oxygen (HBO) 

Therapy should be sent to HBOPA@

cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Hyperbaric Oxygen (HBO) therapy is 

a modality used for treatment of wounds 

in which the entire body is exposed to 

oxygen under increased atmospheric 

pressure. HBO therapy is covered as 

adjunctive therapy only after there have 

been no measurable signs of healing 

during at least 30 consecutive days of 

treatment with standard wound therapy, 

and must be used in addition to 

standard wound care. Wounds must be 

evaluated at least every 30 days during 

administration of HBO therapy. 

Continued treatment with HBO therapy 

is not covered if measurable signs of 

healing have not been demonstrated 

within any 30-day period of treatment. 

Medicare issued a National Coverage 

Determination (NCD) for HBO therapy 

in 2002, which lists clinical conditions 

for which HBO therapy is medically 

necessary and clinical conditions for 

which HBO therapy is not medically 

necessary, and therefore; not covered by 

Medicare. The NCD can be found in the 

Medicare National Coverage 

Determinations Manual (CMS Pub. No. 

100–03), Chapter 1, Part 1, Section 

20.29, and in the NCD database at 

http://www.cms.gov/medicare-coveragedatabase/details/nca-decision-memo.

aspx?NCAId=37&bc=AiAAAAAAA

gAAAA%3d%3d&. In addition, some of 

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