Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49817 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Application for 

Participation in the Intravenous 

Immune Globulin (IVIG) Demonstration; 

Use: Traditional fee-for-service (FFS) 

Medicare covers some or all 

components of home infusion services 

depending on the circumstances. By 

special statutory provision, Medicare 

Part B covers intravenous immune 

globulin (IVIG) for persons with primary 

immune deficiency disease (PIDD) who 

wish to receive the drug at home. 

However, Medicare does not separately 

pay for any services or supplies to 

administer it if the person is not 

homebound and otherwise receiving 

services under a Medicare Home Health 

episode of care. As a result, many 

beneficiaries have chosen to receive the 

drug at their doctor’s office or in an 

outpatient hospital setting. 

On September 29, 2017, the ‘‘Disaster 

Tax Relief and Airport and Airway 

Extension Act of 2017’’ was enacted into 

law. Section 302 of this legislation 

extends the Medicare IVIG 

Demonstration through December 31, 

2020. While existing beneficiaries 

enrolled in the demonstration as of 

September 30, 2017 will be 

automatically re-enrolled, in order to 

continue to enroll new beneficiaries into 

the demonstration, an application is 

required. The original enrollment and 

financial limits remain and CMS will 

continue to monitor both to assure that 

statutory limitations are not exceeded. 

This collection of information is for 

the application to participate in the 

demonstration. Participation is 

voluntary and may be terminated by the 

beneficiary at any time. Beneficiaries 

who do not participate will continue to 

be eligible to receive all of the regular 

Medicare Part B benefits that they are 

would be eligible for in the absence of 

the demonstration. Form Number: 

CMS–10518 (OMB control number: 

0938–1246); Frequency: Annually; 

Affected Public: Individuals and 

households; Number of Respondents: 

1,220; Total Annual Responses: 1,220 

Total Annual Hours: 305. (For policy 

questions regarding this collection 

contact Jody Blatt at 410–786–6921.) 

2. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Generic 

Clearance for Questionnaire Testing and 

Methodological Research for the 

Medicare Current Beneficiary Survey 

(MCBS); Use: The purpose of this OMB 

clearance package is to extend the 

approval of the generic clearance to 

support an effort to evaluate the 

operations and content of the Medicare 

Current Beneficiary Survey (MCBS). The 

MCBS is a continuous, multipurpose 

survey of a nationally representative 

sample of aged, disabled, and 

institutionalized Medicare beneficiaries. 

The MCBS, which is sponsored by the 

Centers for Medicare & Medicaid 

Services (CMS), is the only 

comprehensive source of information on 

the health status, health care use and 

expenditures, health insurance 

coverage, and socioeconomic and 

demographic characteristics of the 

entire spectrum of Medicare 

beneficiaries. The core of the MCBS is 

a series of interviews with a stratified 

random sample of the Medicare 

population, including aged and disabled 

enrollees, residing in the community or 

in institutions. Questions are asked 

about enrollees’ patterns of health care 

use, charges, insurance coverage, and 

payments over time. Respondents are 

asked about their sources of health care 

coverage and payment, their 

demographic characteristics, their 

health and work history, and their 

family living circumstances. In addition 

to collecting information through the 

core questionnaire, the MCBS collects 

information on special topics. Form 

Number: CMS–10549 (OMB control 

number 0938–1275); Frequency: 

Occasionally; Affected Public: 

Individuals or Households; Number of 

Respondents: 1,500; Total Annual 

Responses: 1,500; Total Annual Hours: 

1,117. (For policy questions regarding 

this collection contact William Long at 

410–786–7927.) 

Dated: October 24, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–23451 Filed 10–26–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3336–FN] 

Medicare and Medicaid Programs: 

Approval of an Application From the 

Joint Commission (TJC) for Continued 

CMS Approval of Its Critical Access 

Hospital (CAH) 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 critical access hospitals 

(CAHs) that wish to participate in the 

Medicare or Medicaid programs. 

DATES: This final notice is effective 

November 21, 2017 through November 

21, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Monda Shaver, (410) 786–3410, Karena 

Meushaw, (410) 786–6609 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) and 

1861(mm) of the Social Security Act 

(the Act) establish distinct criteria for 

facilities seeking designation as a CAH. 

The minimum requirements that a CAH 

must meet to participate in the Medicare 

Program are at 42 CFR part 485, subpart 

F. Conditions for Medicare payment for 

CAHs are at 42 CFR 413.70. Applicable 

regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to facility survey and 

certification are at 42 CFR part 488, 

subparts A and B. 

For a CAH to enter into a provider 

agreement with the Medicare program, a 

CAH must first be certified by a State 

survey agency as complying with the 

conditions or requirements set forth in 

section 1820 of the Act and our 

regulations at part 485. Subsequently, 

the CAH is subject to ongoing review by 

a State survey agency to determine 

whether it continues to meet the 

Medicare requirements. However, there 

is an alternative to State compliance 

surveys. Certification by a nationally 

recognized accreditation program can 

substitute for ongoing State review. 

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

that if the Secretary of the Department 


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49818 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

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 the Centers for Medicare & 

Medicaid Services (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 § 488.5. The regulations at 

§ 488.5(e)(2)(i) 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) term of approval 

as a recognized Medicare accreditation 

program for CAHs expires November 21, 

2017. 

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 

On May 19, 2017, we published a 

proposed notice in the Federal Register 

(82 FR 23004) announcing TJC’s request 

for continued approval of its Medicare 

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 § 488.5, we conducted a 

review of TJC’s Medicare CAH 

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 hospital surveyors; (4) 

ability to investigate and respond 

appropriately to complaints against 

accredited hospitals; and (5) survey 

review and decision-making process for 

accreditation. 

• A comparison of TJC’s Medicare 

accreditation program standards to our 

current Medicare CAH Conditions of 

Participation (CoPs). 

• A documentation review of TJC’s 

survey process to do the following: 

++ 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 CAHs. 

++ Evaluate TJC’s procedures for 

monitoring CAHs 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 

§ 488.9(c).) 

++ Assess TJC’s ability to report 

deficiencies to the surveyed hospitals 

and respond to the hospital’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 May 19, 

2017 proposed notice also solicited 

public comments regarding whether 

TJC’s requirements met or exceeded the 

Medicare CoP for CAHs. There were two 

comments submitted, neither of which 

related to the content of 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 CAH 

accreditation requirements and survey 

process with the Medicare CoPs at part 

485, and the survey and certification 

process requirements of parts 488 and 

489. TJC’s standards and crosswalk were 

also examined to ensure that the 

appropriate CMS regulations would be 

included in citations as appropriate. We 

reviewed and evaluated TJC’s CAH 

application, which was conducted as 

described in section III of this final 

notice. As a result TJC has revised the 

following standards and certification 

processes: 

• Section 482.21(d)(2): Updated its 

standards and crosswalk to include a 

comparable standard to allow facilities 

to develop and implement an 

information technology system 

explicitly designed to improve patient 

safety and quality of care as part of its 

quality improvement program. 

• Section 482.21(d)(4): Updated its 

standards and crosswalk to include a 

comparable standard that requires 

facilities that do not participate in a 

cooperative project to implement 

projects that are of comparable effort. 

• Sections 482. 22(b)(4)(iii) through 

(b)(4)(iv): Updated its standards and 

crosswalk to ensure that CAHs are not 

permitted to have a ‘‘unified and 

integrated medical staff.’’ 

• Section 482.28(b)(2): Updated its 

standards and crosswalk to include a 

comparable standard to require that all 

patient diets, including therapeutic 

diets, must be ordered by a practitioner 

responsible for the care of the patient, 

or by a qualified dietitian or qualified 

nutrition professional as authorized by 

the medical staff and in accordance with 

State law governing dietitians and 

nutritional professionals. 

• Section 482.53(b): Updated its 

standards and crosswalk to include the 

‘‘preparation’’ of radioactive materials. 

• Section 485.618(d)(4): Updated its 

standards and crosswalk to address the 

withdrawal of a request for using 

Registered Nurses on a temporary basis 

as part of their State Rural Healthcare 

Plan with the State Boards of Medicine 

and Nursing. 

• Sections 485.627(b)(1) through 

(b)(3): Updated its standards and 


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Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49819 

crosswalk to include comparable 

standards to require disclosure of the 

names and addresses of the facility’s 

owners, or those with a controlling 

interest in the CAH or in any 

subcontractor in which the CAH 

directly or indirectly has a 5 percent or 

more ownership interest. 

• Section 485.645(a)(2): Updated its 

crosswalk to include the correct 

regulatory language to require that the 

facility limits inpatient beds to no more 

than 25 and is verified on all surveys. 

• Section 488.5(a)(4)(vii): Updated its 

policies and review process to ensure 

that approved plans of correction fully 

address all non-compliant practices 

identified during the survey; that 

appropriate policy changes have been 

made to ensure compliance; and that 

plans of correction identify the 

responsible party for ensuring corrective 

actions are implemented within the 

CAH and contain a description of how 

the CAH will monitor and evaluate the 

effectiveness of the corrective actions, 

analyze the data, and report findings to 

the senior leadership and governing 

body to ensure continued regulatory 

compliance. 

• Section 488.5(a)(12): Provided CMS 

with assurance that its procedures for 

responding to, and investigating 

complaints against accredited facilities 

are fully implemented and followed. 

• Section 488.26(b): Revised surveyor 

documentation to include appropriately 

detailed deficiency statements that 

clearly support the determination of 

noncompliance and appropriate level of 

deficiency. 

TJC revised its survey policy and 

procedure to clearly delineate that a 

survey will not occur until after the 

applicable Regional Office has made a 

determination of the CAH’s compliance 

with location and distance 

requirements. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that TJC’s 

CAH program requirements meet or 

exceed our requirements, and its survey 

processes are comparable to ours. 

Therefore, we approve TJC as a national 

accreditation organization for critical 

access hospitals that request 

participation in the Medicare program, 

effective November 21, 2017 through 

November 21, 2023. 

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.). 

Dated: October 16, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2017–23449 Filed 10–26–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9105–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—July Through September 

2017 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This quarterly notice lists 

CMS manual instructions, substantive 

and interpretive regulations, and other 

Federal Register notices that were 

published from July through September 

2017, relating to the Medicare and 

Medicaid programs and other programs 

administered by CMS. 

FOR FURTHER INFORMATION CONTACT: It is 

possible that an interested party may 

need specific information and not be 

able to determine from the listed 

information whether the issuance or 

regulation would fulfill that need. 

Consequently, we are providing contact 

persons to answer general questions 

concerning each of the addenda 

published in this notice. 

BILLING CODE 4120–01–P 

BILLING CODE 4120–01–C 

I. Background 

The Centers for Medicare & Medicaid 

Services (CMS) is responsible for 

administering the Medicare and 

Medicaid programs and coordination 

and oversight of private health 

insurance. Administration and oversight 

of these programs involves the 

following: (1) Furnishing information to 

Medicare and Medicaid beneficiaries, 

health care providers, and the public; 

and (2) maintaining effective 

communications with CMS regional 

offices, state governments, state 

Medicaid agencies, state survey 

agencies, various providers of health 

care, all Medicare contractors that 

process claims and pay bills, National 

Association of Insurance Commissioners 

(NAIC), health insurers, and other 


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