29714 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 

either an onsite survey or the Alternate 

Quality Assessment Survey (i.e., paper 

survey of quality indicators). We 

perform an overview evaluation of the 

completed forms. Each calendar year, a 

summary of the information collected is 

sent to the State and CMS Regional 

Offices. Form Number: CMS–668B 

(OMB Control Number 0938–0653); 

Frequency: Biennially; Affected Public: 

Private sector (Business or other forprofits and Not-for-profit institutions), 

State, Local, or Tribal Government; 

Number of Respondents: 19,051; Total 

Annual Responses: 9,526; Total Annual 

Hours: 2,382. (For policy questions 

regarding this collection contact 

Kathleen Todd at 410–786–3385.) 

Dated: May 19, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–12498 Filed 5–21–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3307–FN] 

Medicare and Medicaid Programs; 

Continued Approval of The Joint 

Commission’s Hospice Accreditation 

Program 

AGENCY: Centers for Medicare & 

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 hospices that wish to 

participate in the Medicare or Medicaid 

programs. A hospice that participates in 

Medicaid must also meet the Medicare 

Conditions of Participation (CoPs). 

DATES: This final notice is effective June 

18, 2015 through June 18, 2021. 

FOR FURTHER INFORMATION CONTACT: 

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 hospice provided certain 

requirements are met by the hospice. 

Section 1861(dd) of the Social Security 

Act (the Act) establishes distinct criteria 

for facilities seeking designation as a 

hospice. 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 418 specify 

the conditions that a hospice must meet 

in order to participate in the Medicare 

program, the scope of covered services 

and the conditions for Medicare 

payment for hospices. 

Generally, to enter into an agreement, 

a hospice must first be certified as 

complying with the conditions set forth 

in part 418 and recommended to the 

Center for Medicare & Medicaid (CMS) 

for participation by a state survey 

agency. Thereafter, the hospice is 

subject to periodic surveys by a state 

survey agency to determine whether it 

continues to meet these conditions. 

However, there is an alternative to 

certification surveys by state agencies. 

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, CMS 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 CMS 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 determined by CMS. The Joint 

Commission’s (TJC’s) current term of 

approval for its hospice accreditation 

program expires June 18, 2015. 

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 December 19, 2014 Federal 

Register (79 FR 75817), we published a 

proposed notice announcing TJC’s 

request for continued approval of its 

Medicare hospice accreditation 

program. In the December 19, 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 

hospice 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 hospice surveyors; (4) 

ability to investigate and respond 

appropriately to complaints against 

accredited hospices; and (5) survey 

review and decision-making process for 

accreditation. 

• The comparison of TJC’s Medicare 

hospice accreditation program standards 

to our current Medicare hospice CoPs. 

• 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 

we require of state survey agencies, 

including periodic resurvey and the 

ability to investigate and respond 

appropriately to complaints against 

accredited hospices. 

++ Evaluate TJC’s procedures for 

monitoring hospices it has 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)). 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 29715 

++ Assess TJC’s ability to report 

deficiencies to the surveyed hospice and 

respond to the hospice’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 

as we may require, including corrective 

action plans. 

In accordance with section 

1865(a)(3)(A) of the Act, the December 

19, 2014 proposed notice also solicited 

public comments regarding whether 

TJC’s requirements met or exceeded the 

Medicare CoPs for hospices. No 

comments were received in response to 

the 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 hospice 

accreditation requirements and survey 

process with the Medicare CoPs of part 

418, and the survey and certification 

process requirements of parts 488 and 

489. Our review and evaluation of TJC’s 

hospice 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, 

TJC is in the process of or has 

completed revising its standards and 

certification processes to meet the 

requirements at: 

• § 418.52(a)(1), to ensure hospices’ 

provide verbal notification of the 

patient’s rights and responsibilities. 

• § 418.52(b)(4)(i), to ensure all 

alleged violations of mistreatment are 

immediately reported to the hospice 

administrator. 

• § 418.54(c)(6) and § 418.54(c)(6)(v), 

to ensure the patient’s prescriptions, 

over the counter drugs, including herbal 

remedies and other alternative 

treatments, and drug therapy associated 

with laboratory monitoring are reviewed 

when completing the comprehensive 

assessment. 

• § 418.58(d)(1), to ensure that the 

number and scope of distinct 

performance improvement projects 

conducted annually, based on the needs 

of the hospice’s population and internal 

organizational needs, reflect the scope, 

complexity, and past performance of the 

hospice’s operations. 

• § 418.58(e)(1), to ensure the ongoing 

quality improvement and patient safety 

program is evaluated annually. 

• § 418.64(d)(3)(iv), to ensure the 

family is advised of the availability of 

spiritual counseling services. 

• § 418.76(c)(4), to ensure the direct 

supervision of the hospice aide training 

is completed by a registered nurse. 

• § 418.76(g)(1), to ensure written 

patient care instructions for the hospice 

aide are prepared by a registered nurse 

who is responsible for the supervision 

of the hospice aide. 

• § 418.76(h)(1)(i), to ensure the 

registered nurse’s supervision of the 

hospice aide includes an assessment of 

the quality of care and services provided 

by the hospice aide and to ensure that 

services ordered by the hospice 

interdisciplinary group meet the 

patient’s needs. 

• § 418.78(a), to ensure the hospice 

maintains, documents, and provides 

volunteer orientation and training that 

is consistent with hospice industry 

standards. 

• § 418.104(a)(2), to address the 

requirement that hospices include a 

signed copy of the election statement in 

the patient’s clinical record. 

• § 418.106(a)(1), to ensure the 

interdisciplinary group ‘‘confers’’ with 

an individual with education and 

training in drug management to make 

sure drugs and biologicals meet the 

patient’s needs. 

• § 418.106(e)(2)(i)(B), to address the 

requirement for the hospice to educate 

the patient, or representative and the 

family on the safe use and disposal of 

controlled drugs ‘‘in a language and 

manner that they understand.’’ 

• § 418.106(e)(3)(i), to address the 

requirement that only personnel 

authorized to administer controlled 

drugs have access to the locked 

compartments. 

• § 418.108(c)(5), to address when 

inpatient care is provided under 

arrangement, that the hospice retains a 

description of the training provided and 

documents the names of those giving 

the training. 

• § 418.110(d), to ensure the Life 

Safety Code (LSC) requirements apply to 

all certified in-patient hospice facilities 

regardless of the number of certified 

beds. 

• § 418.110(f)(3)(vi), to ensure patient 

rooms are equipped with an easilyactivated, functioning and accessible 

device that is used for calling for 

assistance. 

• § 418.110(m), to ensure all patients 

have the right to be free from physical 

or mental abuse and corporal 

punishment. 

• § 418.110(m)(7)(ii), to address that 

each order for restraint used ensures the 

physical safety of the non-violent or 

non-self-destructive patients. 

• § 418.114(d)(1), to address the 

requirement that all contracted entities 

obtain criminal background checks on 

contracted employees who have direct 

patient contact or access to patient 

records. 

• § 488.4(a)(3)(ii), to ensure 

compliance with its own policies 

related to the minimum number of 

medical records reviewed while 

conducting an onsite hospice survey. 

• § 488.4(a)(4)(i), to clarify the 

minimum size and composition of its 

survey team for its Medicare hospice 

accreditation program. 

• § 488.4(a)(4)(ii) through (v), to 

ensure its surveyors are appropriately 

qualified, trained, and evaluated. 

• § 488.4(a)(6), to ensure the 

minimum number of medical records 

are reviewed for complaint surveys. 

• § 488.8(a)(2)(v), to ensure data 

reported to CMS is accurate and 

complete. 

• § 488.26(b), to improve surveyors’ 

abilities to— 

++ Accurately and completely 

document instances of non-compliance 

at the appropriate level of citation 

(condition versus standard level 

citations). 

++ Ensure that all instances of 

observed non-compliance are 

documented in the survey report. 

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 hospices 

that request participation in the 

Medicare program, effective June 18, 

2015 through June 18, 2021. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting recordkeeping or thirdparty 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. 35). 

Dated: May 5, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–12524 Filed 5–21–15; 8:45 am] 

BILLING CODE 4120–01–P 


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