Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 29479 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

proposed rule will not have substantial 

direct effects on tribal governments, on 

the relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this proposed rule. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 14, 2010. 

Steven Bradbury, 

Acting Director, Office of Pesticide Programs. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 180—[AMENDED] 

1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

§ 180.110 [Removed] 

2. Section 180.110 is removed. 

[FR Doc. 2010–12376 Filed 5–25–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 482 and 485 

[CMS–3227–P] 

RIN 0938–AQ05 

Medicare and Medicaid Programs: 

Proposed Changes Affecting Hospital 

and Critical Access Hospital (CAH) 

Conditions of Participation (CoPs): 

Credentialing and Privileging of 

Telemedicine Physicians and 

Practitioners 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

revise the conditions of participation 

(CoPs) for both hospitals and critical 

access hospitals (CAHs). These revisions 

would allow for a new credentialing and 

privileging process for physicians and 

practitioners providing telemedicine 

services. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 26, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–3227–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3227– 

P, P.O. Box 8010, Baltimore, MD 21244– 

1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3227–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. (Because 

access to the interior of the Hubert H. 

Humphrey Building is not readily 

available to persons without Federal 

government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is 

available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the 

comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244– 

1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by following 

the instructions at the end of the 

‘‘Collection of Information 

Requirements’’ section in this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: CDR 

Scott Cooper, USPHS (410) 786–9465. 

Marcia Newton, (410) 786–5265. Jeannie 

Miller, (410) 786–3164. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244, on Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. EST. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

Electronic Access 

This Federal Register document is 

also available from the Federal Register 

online database through GPO Access, a 

service of the U.S. Government Printing 

Office. Free public access is available on 

a Wide Area Information Server (WAIS) 

through the Internet and via 

asynchronous dial-in. Internet users can 

access the database by using the World 

Wide Web (the Superintendent of 

Documents’ home page address is 

http://www.gpoaccess.gov/index.html), 

by using local WAIS client software, or 

by telnet to swais.access.gpo.gov, then 

login as guest (no password required). 

Dial-in users should use 

communications software and modem 

to call (202) 512–1661; type swais, then 

login as a guest (no password required). 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
29480 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 

I. Background 

The current Medicare Hospital 

conditions of participation (CoPs) for 

credentialing and privileging of medical 

staff at 42 CFR 482.12(a)(2) and 

482.22(a)(2) require the governing body 

of the hospital to make all privileging 

decisions based upon the 

recommendations of its medical staff 

after the medical staff has thoroughly 

examined and verified the credentials of 

practitioners applying for privileges, 

and also used specific criteria to 

determine whether an individual 

practitioner should be privileged at the 

hospital. The current critical access 

hospital (CAH) CoPs at 42 CFR 

485.616(b) require every CAH that is a 

member of a rural health network to 

have an agreement for review of 

physicians and practitioners seeking 

privileges at the CAH. The agreement 

must be with a hospital that is a member 

of the network, a Medicare Quality 

Improvement Organization (QIO), or 

another qualified entity identified in the 

State’s rural health plan. In addition, the 

services provided by each doctor of 

medicine or osteopathy at the CAH must 

be evaluated by one of these same three 

types of outside parties. These 

requirements apply to all physicians 

and practitioners seeking privileges at 

the hospital or CAH, regardless of 

whether services will be provided inperson and on-site at the hospital or 

CAH, or remotely through a 

telecommunications system. CMS 

regulations currently require hospitals 

and CAHs receiving telemedicine 

services to privilege each physician or 

practitioner providing services to its 

patients as if such practitioner were onsite. 

While hospitals may use third party 

credentialing verification organizations 

to relieve the time-consuming burden of 

compiling and verifying the credentials 

of practitioners applying for privileges, 

the hospital’s governing body is still 

responsible for all privileging decisions. 

Similarly, each CAH is required to have 

its privileging decisions made by either 

its governing body or the person 

responsible for the CAH. 

In the past, hospitals that were 

accredited by the Joint Commission 

(TJC) were deemed to have met the 

Medicare CoPs, including the 

credentialing and privileging 

requirements, under TJC’s statutory 

deeming authority. Section 125 of the 

Medicare Improvements for Patients and 

Providers Act of 2008 (Pub. L. 110–275, 

July 15, 2008) (MIPPA), terminated the 

statutory recognition of TJC’s hospital 

accreditation program, effective July 15, 

2010. The law requires TJC to secure 

CMS approval of its standards in order 

to confer Medicare deemed status on 

hospitals after July 15, 2010. This means 

that we do not have the discretion under 

the law to accept TJC policies or 

standards that do not meet or exceed the 

Medicare CoPs. One TJC policy that has 

been in direct conflict with the CoPs has 

been TJC’s practice of permitting 

‘‘privileging by proxy,’’ which has 

allowed TJC-accredited hospitals to 

utilize a different methodology to 

privilege ‘‘distant-site’’ (as that term is 

defined at section 1834(m)(4)(A) of the 

Social Security Act (the Act)) physicians 

and practitioners. In short, TJC 

privileging by proxy standards allowed 

for one TJC-accredited facility to accept 

the privileging decisions of another TJCaccredited facility. Hospitals that have 

used this method to privilege distantsite medical staff technically did not 

meet CMS requirements that applied to 

other hospitals even though they were 

TJC-accredited. When CMS learned of 

specific instances of such 

noncompliance through on-site surveys 

by State Survey Agencies, the hospital 

was required to change its policies to 

come into compliance. 

As of July 15, 2010, TJC will be 

statutorily required to enforce CMS 

requirements regarding privileging 

physicians and practitioners in the 

hospitals they accredit, both those 

providing and those receiving 

telemedicine services. TJC-accredited 

hospitals, therefore, are concerned that 

they may be unable to meet the longstanding CMS privileging requirements 

while sustaining their current 

telemedicine agreements. Small hospital 

and CAH medical staffs, in particular, 

are concerned about the burden of 

privileging hundreds of specialty 

physicians and practitioners that large 

academic medical centers make 

available to them. 

Upon reflection, we came to the 

conclusion that our present requirement 

is a duplicative and burdensome 

process for physicians, practitioners, 

and the hospitals involved in this 

process, particularly small hospitals, 

which often lack adequate resources to 

fully carry out the traditional 

credentialing and privileging process for 

all of the physicians and practitioners 

that may be available to provide 

telemedicine services. In addition to the 

costs involved, small hospitals often do 

not have in-house medical staff with the 

clinical expertise to adequately evaluate 

and privilege the wide range of specialty 

physicians that larger hospitals can 

provide through telemedicine services. 

CMS has become increasingly aware, 

through outreach efforts and 

communications with the various 

stakeholders in the telemedicine 

community (for example, large 

academic medical centers that provide 

telemedicine services; small hospitals 

that make effective use of these services 

for the benefit of their patients; 

representative professional 

organizations; and Congressional 

representatives whose various 

constituencies are made up of 

telemedicine practitioners as well as the 

patients receiving telemedicine 

services), of the urgent need to revise 

the CoPs in this area so that access to 

these vital services may continue in a 

manner that is both safe and beneficial 

for patients and is free of unnecessary 

and duplicative regulatory 

impediments. 

II. Provisions of the Proposed Rule 

The following provisions of this 

proposed rule would apply to all 

hospitals and CAHs participating in the 

Medicare and Medicaid programs. 

Section 1861(e)(1) through (9) of the 

Act: (1) Defines the term ‘‘hospital’’; (2) 

lists the statutory requirements that a 

hospital must meet to be eligible for 

Medicare participation; and (3) specifies 

that a hospital must also meet other 

requirements as the Secretary finds 

necessary in the interest of the health 

and safety of the hospital’s patients. 

Under this authority, the Secretary has 

established in the regulations 42 CFR 

part 482, the requirements that a 

hospital must meet to participate in the 

Medicare program. Section 1905(a) of 

the Act provides that Medicaid 

payments may be applied to hospital 

services. Regulations at 42 CFR 

440.10(a)(3)(iii) require hospitals to 

meet the Medicare CoPs to qualify for 

participation in Medicaid. 

We recognize the advantages and 

benefits that telemedicine provides for 

patients and are interested in reducing 

the burden and the duplicative efforts of 

the traditional credentialing and 

privileging process for Medicareparticipating hospitals, both those 

which provide telemedicine services 

and those which use such services. 

Therefore, we are proposing to revise 

both the hospital and CAH credentialing 

and privileging requirements to 

eliminate these regulatory impediments 

and allow for the advancement of 

telemedicine nationwide while still 

protecting the health and safety of 

patients. We believe that these proposed 

revisions would preserve and strengthen 

the core values of the credentialing and 

privileging process for all hospitals: 

accountability to all patients, and 

assurance that medical staff are 

privileged to provide services in the 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 29481 

hospital based on evaluation of the 

practitioner’s medical competency. 

Hospital CoPs (§ 482.12 and § 482.22) 

The proposed revisions to the hospital 

CoPs for the credentialing and 

privileging of telemedicine physicians 

and practitioners are contained within 

two separate CoPs: § 482.12, ‘‘Governing 

body,’’ and § 482.22, ‘‘Medical staff.’’ 

For the Governing body CoP, we are 

proposing to add a new paragraph, 

§ 482.12(a)(8), which would require the 

hospital’s governing body to ensure that, 

when telemedicine services are 

furnished to the hospital’s patients 

through an agreement with a Medicareparticipating hospital (the ‘‘distant-site’’ 

hospital as defined at section 

1834(m)(4)(A) of the Act), the agreement 

must specify that it is the responsibility 

of the governing body of the distant-site 

hospital providing the telemedicine 

services to meet the existing 

requirements in § 482.12(a)(1) through 

(a)(7) with regard to its physicians and 

practitioners who are providing 

telemedicine services. These existing 

provisions cover the distant-site 

hospital’s governing body 

responsibilities for its medical staff that 

all Medicare-participating hospitals 

must meet. 

The proposed requirements at 

§ 482.12(a)(8) would allow the 

governing body of the hospital whose 

patients are receiving the telemedicine 

services to grant privileges based on its 

medical staff recommendations, which 

would rely on information provided by 

the distant-site hospital, as a more 

efficient means of privileging the 

individual distant-site physicians and 

practitioners providing the services. 

This provision would be accompanied 

by the proposed requirement in the 

‘‘Medical staff’’ CoP at § 482.22(a)(3), 

which would provide the basis on 

which the hospital’s governing body, 

through its agreement as noted above, 

can choose to have its medical staff rely 

upon information furnished by the 

distant-site hospital when making 

recommendations on privileges for the 

individual physicians and practitioners 

providing such services. This option 

would allow the hospital’s medical staff 

to rely upon the credentialing and 

privileging decisions of the distant-site 

hospital in lieu of the current 

requirements at § 482.22(a)(1) and (a)(2), 

which require the hospital’s medical 

staff to conduct individual appraisals of 

its members and examine the 

credentials of each candidate in order to 

make a privileging recommendation to 

the governing body. This option would 

not prohibit a hospital’s medical staff 

from continuing to perform its own 

periodic appraisals of telemedicine 

members of its staff, nor would it bar 

them from continuing to use the 

traditional credentialing and privileging 

process required under the current 

regulations. The intent of this proposed 

requirement is to relieve burden for 

smaller hospitals by providing for a less 

duplicative and more efficient 

privileging scheme with regard to 

physicians and practitioners providing 

telemedicine services. 

However, in an effort to ensure 

accountability to the process, we are 

proposing within this same provision 

(§ 482.22(a)(3)) that the hospital, in 

order to choose this less burdensome 

option for privileging, must ensure 

that—(1) The distant-site hospital 

providing the telemedicine services is a 

Medicare-participating hospital; (2) the 

individual distant-site physician or 

practitioner is privileged at the distantsite hospital providing telemedicine 

services, and that this distant-site 

hospital provides a current list of the 

physician’s or practitioner’s privileges; 

(3) the individual distant-site physician 

or practitioner holds a license issued or 

recognized by the State in which the 

hospital, whose patients are receiving 

the telemedicine services, is located; 

and (4) with respect to a distant-site 

physician or practitioner granted 

privileges by the hospital, the hospital 

has evidence of an internal review of the 

distant-site physician’s or practitioner’s 

performance of these privileges and 

sends the distant-site hospital this 

information for use in its periodic 

appraisal of the individual distant-site 

physician or practitioner. We are also 

proposing, at a minimum, the 

information sent for use in the periodic 

appraisal would have to include all 

adverse events that may result from 

telemedicine services provided by the 

distant-site physician or practitioner to 

the hospital’s patients and all 

complaints the hospital has received 

about the distant-site physician or 

practitioner. 

Within the revisions to the hospital 

CoPs, we are also proposing that 

additional language be added to the 

current requirement at § 482.22(c)(6), 

which requires that the hospital’s 

medical staff bylaws include criteria for 

determining privileges and a procedure 

for applying the criteria to individuals 

requesting privileges. We are proposing 

to add language to stipulate that in cases 

where distant-site physicians and 

practitioners are requesting privileges to 

furnish telemedicine services through 

an agreement between hospitals, the 

criteria for determining those privileges 

and the procedure for applying the 

criteria would be subject to the 

proposed requirements at § 482.12(a)(8) 

and § 482.22(a)(3). 

Critical Access Hospital (CAH) CoPs 

(§ 485.616 and § 485.641) 

The proposed revisions to the CAH 

CoPs are found at § 485.616, 

‘‘Agreements,’’ and § 485.641, ‘‘Periodic 

evaluation and quality assurance 

review.’’ However, the majority of the 

proposed revisions, particularly those 

which mirror the proposed hospital 

revisions, are found in the ‘‘Agreements’’ 

CoP, specifically § 485.616(c). We are 

proposing to add a new standard at 

§ 485.616(c) entitled, ‘‘Agreements for 

credentialing and privileging of 

telemedicine physicians and 

practitioners.’’ 

The proposed telemedicine 

credentialing and privileging 

requirements for CAHs are modeled 

after the hospital requirements, with 

almost no differences in the regulatory 

language. Since the only existing 

requirements in the CAH CoPs specific 

to the responsibility of the governing 

body to grant medical staff privileges 

concerns surgical privileges for 

practitioners, we are proposing to add 

language that follows the language in 

the hospital requirements at § 482.12(a). 

This language delineates the 

responsibilities of the governing body 

for the medical staff privileging process. 

At § 485.641(b)(4)(iv), we would make 

a minor change to the CAH CoPs that do 

not have an equivalent provision in the 

hospital CoPs. We are proposing to add 

a new requirement that would allow the 

distant-site hospital to evaluate the 

quality and appropriateness of the 

diagnosis and treatment furnished by its 

own staff when providing telemedicine 

services to the CAH. This proposed 

requirement would be in addition to the 

three other entities already allowed to 

perform this function under the existing 

regulations. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 60- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
29482 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We are soliciting public comment on 

each of these issues for the following 

sections of this document that contain 

information collection requirements 

(ICRs): 

A. ICRs Regarding Condition of 

Participation: Governing Body (§ 482.12) 

Section 482.12(a)(8) would require the 

governing body of a hospital to ensure 

that, when telemedicine services are 

furnished to the hospital’s patients 

through an agreement with a distant-site 

hospital, the agreement specifies that it 

is the responsibility of the governing 

body of the distant-site hospital to meet 

the requirements in paragraphs (1) 

through (7) of this subsection with 

regard to its physicians and 

practitioners providing telemedicine 

services. The burden associated with 

this requirement would be the time and 

effort necessary for a hospital’s 

governing body to develop, initially 

review, and annually review the 

agreement with a distant-site hospital. 

We estimate that 4,860 hospitals (not 

including 1,314 CAHs) must develop 

the aforementioned written agreement. 

We also estimate that the development 

and review of the agreement would take 

1,440 minutes initially and the review 

would take 360 minutes annually. The 

total cost associated with this proposed 

requirement is $2,346. 

B. ICRs Regarding Condition of 

Participation: Medical Staff (§ 482.22) 

Section 482.22(a)(3) states that when 

telemedicine services are furnished to a 

hospital’s patients through an agreement 

with a distant-site hospital, the 

governing body of the hospital whose 

patients are receiving the telemedicine 

services may choose to have its medical 

staff rely upon information furnished by 

the distant-site hospital when making 

recommendations on privileges for the 

individual physicians and practitioners 

providing such services. To do this, a 

hospital’s governing body must ensure 

that all of the provisions listed at 

§ 482.22(a)(3)(i) through (iv) are met. 

Specifically, § 482.22(a)(3)(iv) contains a 

third-party disclosure requirement. 

Section 482.22(a)(3)(iv) states that with 

respect to a distant-site physician or 

practitioner granted privileges, the 

hospital whose patients are receiving 

the telemedicine services, has evidence 

of an internal review of the distant-site 

physician’s or practitioner’s 

performance of these privileges and 

sends the distant-site hospital such 

information for use in the periodic 

appraisal of the distant-site physician or 

practitioner. At a minimum, this 

information would include all adverse 

events that result from the telemedicine 

services provided by the distant-site 

physician or practitioner to the 

hospital’s patients and all complaints 

the hospital has received about the 

distant-site physician or practitioner. 

The burden associated with this thirdparty disclosure requirement would be 

the time and effort necessary for a 

hospital to send evidence of a distantsite physician’s or practitioner’s 

performance review to the distant-site 

hospital with which it has an agreement 

for providing telemedicine services. We 

estimate 4,860 hospitals (not including 

1,314 CAHs) would have to comply 

with this requirement. Similarly, we 

estimate that each disclosure would take 

60 minutes and that there would be 

approximately 32 annual disclosures. 

The estimated cost associated with this 

proposed requirement is $1,248. 

C. ICRs Regarding Condition of 

Participation: Agreements (§ 485.616) 

Section 485.616(c)(1) would state that 

the governing body of the CAH must 

ensure that, when telemedicine services 

are furnished to the CAH’s patients 

through an agreement with a distant-site 

hospital, the agreement specifies that it 

is the responsibility of the governing 

body of the distant-site hospital to meet 

the proposed requirements listed at 

§ 485.616(c)(1)(i) through (vii) and 

§ 485.616(c)(2). The burden associated 

with this proposed requirement would 

be the time and effort necessary for a 

CAH’s governing body to develop, 

initially review, and annually review 

the agreement with a distant-site 

hospital. We estimate that 1,314 CAHs 

must develop and review the 

aforementioned written agreement. We 

also estimate that development and 

review of the agreement would take 

1440 minutes initially and the review 

would take 360 minutes annually. The 

total cost associated with this proposed 

requirement is $2,346. 

Section 485.616(c)(2) would state that 

when telemedicine services are 

furnished 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 made by the 

governing body of the distant-site 

hospital for individual distant-site 

physicians or practitioners, if the CAH’s 

governing body or responsible 

individual ensures that all of the 

provisions listed at § 485.616(c)(2)(i) 

through (iv) are met. The burden 

associated with this third-party 

disclosure requirement at 

§ 485.616(c)(2)(iv) would be the time 

and effort necessary for a CAH to send 

evidence of a distant-site physician’s or 

practitioner’s performance review to the 

distant-site hospital with which it has 

an agreement for providing telemedicine 

services. We estimate 1,314 CAHs 

would have to comply with this 

proposed requirement. Similarly, we 

estimate that each disclosure would take 

60 minutes and that there would be 

approximately 32 annual disclosures. 

The estimated cost associated with this 

proposed requirement is $1,248. 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 29483 

TABLE 1—ANNUAL

REPORTING AND

RECORDKEEPING

BURDEN

Regulation 

section(s) 

OMB 

control No. Respondents Responses 

Burden per 

response 

(hours) 

Total 

annual 

burden 

(hours) 

Hourly 

labor 

cost of 

reporting 

($) 

Total labor 

cost of 

reporting 

($) 

Total capital/ 

maintenance 

costs 

($) 

Total cost 

($) 

§ 482.12(a)(8) ................................................ 0938–New 4,860 4,860 24 116,640 ** 8,942,400 0 8,942,400 

...................... 4,860 4,860 6 29,160 ** 2,459,160 0 2,459,160 

§ 482.22(a)(3) ................................................ 0938–New 4,860 155,520 1 155,520 39 6,065,280 0 6,065,280 § 485.616(c)(1) ............................................... 0938–New 1,314 1,314 24 31,536 ** 2,417,760 0 2,417,760 

...................... 1,314 1,314 6 7,884 ** 664,884 0 664,884 

§ 485.616(c)(2) ............................................... 0938–New 1,314 42,048 1 42,048 39 1,639,872 0 1,639,872 

Total ........................................................ ...................... 6,174 209,916 ...................... 382,788 ...................... ...................... ...................... ......................

** Wage rates vary by level of staff involved in complying with the information collection request (ICR). The wage rates associated with the aforementioned information collection requirements are listed in Tables 2–9 in the regulatory impact analysis of this proposed rule. 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
29484 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 

If you comment on these information 

collection and recordkeeping 

requirements, please do either of the 

following: 

1. Submit your comments 

electronically as specified in the 

ADDRESSES section of this proposed rule; 

or 

2. Submit your comments to the 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Attention: CMS Desk Officer, 

CMS–3227–IFC. 

Fax: (202) 395–6974; or 

E-mail: 

OIRA_submission@omb.eop.gov. 

IV. Response to 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. 

V. Regulatory Impact Analysis 

A. Overall Impact 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), the 

Regulatory Flexibility Act (RFA) 

(September 19, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act (the Act), section 202 of the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4), Executive Order 13132 

on Federalism (August 4, 1999), and the 

Congressional Review Act (5 U.S.C. 

804(2)). 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

in any 1 year). This proposed rule is not 

an economically significant rule and 

does not impose significant costs. The 

benefits of finalizing this proposed rule 

would greatly outweigh any costs 

imposed. Conversely, the negative 

impacts on overall patient health and 

safety as well as on the operating costs 

of individual hospitals were this rule 

not to be finalized would be significant 

compared to the minimal cost imposed. 

Accordingly, we have prepared a 

regulatory impact analysis, which to the 

best of our ability, presents the costs 

and benefits of the rulemaking. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses, if a rule has a significant 

impact on a substantial number of small 

entities. For purposes of the RFA, we 

estimate that the great majority of 

hospitals, including CAHs, are small 

entities as that term is used in the RFA. 

Individuals and States are not included 

in the definition of a small entity. While 

we do not believe that this proposed 

rule would have a significant impact on 

small entities, we do believe, as we have 

stated previously, that this rule would 

have a positive impact by providing 

immediate regulatory relief for these 

small entities and would negatively 

impact them if not finalized. Therefore, 

we are voluntarily preparing a 

Regulatory Flexibility Analysis. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a metropolitan statistical area and has 

fewer than 100 beds. This rule would 

not have a significant impact on small 

rural hospitals as it is intended to 

relieve the burden on hospitals, 

particularly on small rural hospitals and 

CAHs, and to reduce or eliminate the 

impact of the current regulatory 

impediments to efficient operation and 

patient access to essential healthcare 

services. Therefore, the Secretary has 

determined that this proposed rule 

would not have a significant negative 

impact on the operations of a substantial 

number of small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

also requires that agencies assess 

anticipated costs and benefits before 

issuing any rule whose mandates 

require spending in any 1 year of $100 

million in 1995 dollars, updated 

annually for inflation. In 2010, that 

threshold is approximately $135 

million. This rule does not contain 

mandates that would impose spending 

costs on State, local, or tribal 

governments in the aggregate, or by the 

private sector, of $135 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This proposed rule would not have a 

substantial direct effect on State or local 

governments, preempt States, or 

otherwise have a Federalism 

implication. 

B. Anticipated Effects 

1. Effects on Hospitals and Critical 

Access Hospitals (CAHs) 

We estimate the costs to hospitals and 

CAHs to implement this proposed rule 

to be minimal. The major costs are 

related to the agreement between the 

distant-site hospital and the hospital or 

CAH at which patients who receive the 

telemedicine services are located. Many 

hospitals and CAHs already have such 

telemedicine service agreements in 

place and would not incur the initial 

costs of developing and reviewing such 

an agreement. 

Our figures, as of March 31, 2010, 

indicate that there were 4,860 hospitals 

and 1,314 CAHs (for a total of 6,174) in 

the United States. However, we have no 

way of determining an exact number on 

which of these hospitals provide 

telemedicine services and which of 

these hospitals and CAHs receive 

services, nor can we determine how 

many hospitals and CAHs already have 

telemedicine agreements. Accordingly, 

we have based on our cost estimates on 

the higher costs that would be incurred 

if every hospital and CAH in the United 

States were required to develop the 

agreement, to review it initially, and to 

review it annually. We prepared the cost 

estimates for hospitals and CAHs 

separately. However, all sides of this 

equation would require the initial 

services of a hospital or CAH attorney 

at an average of $66/hour; a hospital or 

CAH chief of the medical staff (a 

physician) at an average of $112/hour; 

and a hospital or CAH administrator at 

an average of $75/hour. For the thirdparty disclosure requirements, we also 

prepared the cost estimates for hospitals 

and CAHs separately, though both 

would require the annual services of a 

medical staff credentialing manager or a 

medical staff coordinator at an average 

of $39/hour. Our salary figures are from 

http://www.salary.com/. Our estimates 

of time and cost for each aspect of the 

proposed agreement (development, 

initial review, and annual review), as 

well as for the third-party disclosure, is 

as follows: 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 29485 

TABLE 2—INFORMATION COLLECTION REQUIREMENTS FOR A HOSPITAL TO DEVELOP AN AGREEMENT FOR TELEMEDICINE

SERVICES: INITIAL COST

Individual Hourly 

wage 

Number of 

hours 

Cost per 

individual Total cost 

Attorney ............................................................................................................................ $66 8 $528 

Physician .......................................................................................................................... 112 2 224 $1052 

Hospital Administrator ...................................................................................................... 75 4 300 

TABLE 3—INFORMATION COLLECTION REQUIREMENTS FOR A HOSPITAL TO REVIEW AN AGREEMENT FOR TELEMEDICINE

SERVICES: INITIAL COST

Individual Hourly 

wage 

Number of 

hours 

Cost per 

individual Total Cost 

Attorney ............................................................................................................................ $66 4 $264 

Physician .......................................................................................................................... 112 2 224 $788 

Hospital Administrator ...................................................................................................... 75 4 300 

TABLE 4—INFORMATION COLLECTION REQUIREMENTS FOR A HOSPITAL TO REVIEW AN AGREEMENT FOR TELEMEDICINE

SERVICES: ANNUAL COST

Individual Hourly 

wage 

Number of 

hours 

Cost per 

individual Total cost 

Attorney ............................................................................................................................ $66 2 $132 

Physician .......................................................................................................................... 112 2 224 $506 

Hospital Administrator ...................................................................................................... 75 2 150 

Therefore, we estimate the total initial 

cost to develop and review the 

agreement for all 4,860 hospitals to be 

$8.9 million. The annual cost to review 

agreements for all hospitals is estimated 

at $2.5 million. 

TABLE 5—INFORMATION COLLECTION REQUIREMENTS FOR A CAH TO DEVELOP AN AGREEMENT FOR TELEMEDICINE

SERVICES: INITIAL COST

Individual Hourly 

wage 

Number of 

hours 

Cost per 

individual 

Total 

cost 

Attorney ............................................................................................................................ $66 8 $528 

Physician .......................................................................................................................... 112 2 224 $1052 

CAH Administrator ........................................................................................................... 75 4 300 

TABLE 6—INFORMATION COLLECTION REQUIREMENTS FOR A CAH TO REVIEW AN AGREEMENT FOR TELEMEDICINE

SERVICES: INITIAL COST

Individual Hourly 

wage 

Number of 

hours 

Cost per 

individual 

Total 

cost 

Attorney ............................................................................................................................ $66 4 $264 

Physician .......................................................................................................................... 112 2 224 $788 

CAH Administrator ........................................................................................................... 75 4 300 

TABLE 7—INFORMATION COLLECTION REQUIREMENTS FOR A CAH TO REVIEW AN AGREEMENT FOR TELEMEDICINE

SERVICES: ANNUAL COST

Individual Hourly 

wage 

Number of 

hours 

Cost per 

individual 

Total 

cost 

Attorney ............................................................................................................................ $66 2 $132 

Physician .......................................................................................................................... 112 2 224 $506 

Hospital administrator ...................................................................................................... 75 2 150 

Therefore, we estimate the total initial 

cost to develop and review the 

agreement for all 1,314 CAHs to be $2.4 

million. The annual cost to review 

agreements for all CAHs is estimated at 

$664,884. 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
29486 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 

TABLE 8—INFORMATION COLLECTION REQUIREMENTS FOR A HOSPITAL TO PREPARE AND SEND INDIVIDUAL PERFORMANCE

REVIEWS FOR TELEMEDICINE SERVICES (THIRD-PARTY DISCLOSURE): ANNUAL COST

Individual Hourly 

wage 

Number of 

hours 

Cost per 

individual 

Total 

cost 

Medical Staff Coordinator or Medical Staff Credentialing Manager ................................ $39 32 $1,248 $1,248 

Therefore, we estimate the total 

annual cost to prepare and send 

individual performance reviews for 

telemedicine services (third-party 

disclosure) for all 4,860 hospitals to be 

$6.1 million. 

TABLE 9—INFORMATION COLLECTION REQUIREMENTS FOR A CAH TO PREPARE AND SEND INDIVIDUAL PERFORMANCE

REVIEWS FOR TELEMEDICINE SERVICES (THIRD-PARTY DISCLOSURE): ANNUAL COST

Individual Hourly wage Number of 

hours 

Cost per individual Total cost 

Medical Staff Coordinator or Medical Staff Credentialing Manager ................................ $39 32 $1248 $1248 

Therefore, we estimate the total 

annual cost to prepare and send 

individual performance reviews for 

telemedicine services (third-party 

disclosure) for all 1,314 CAHs to be $1.6 

million. 

The total cost of the information 

collection requirements for both 

hospitals and CAHs is estimated to be 

$22.1 million. 

C. Conclusion 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects 

42 CFR Part 482 

Grant programs—Health, Hospitals, 

Medicaid, Medicare, Reporting and 

recordkeeping requirements 

42 CFR Part 485 

Grant programs—Health, Health 

facilities, Medicaid, Medicare, 

Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR chapter IV as set forth below: 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

1. The authority citation for part 482 

continues to read as follows: 

Authority: Secs. 1102, 1871 and 1881 of 

the Social Security Act (42 U.S.C. 1302, 

1395hh, and 1395rr), unless otherwise noted. 

Subpart B—Administration 

2. Section 482.12 is amended by 

adding a new paragraph (a)(8) to read as 

follows: 

§ 482.12 Condition of participation: 

Governing body. 

* * * * * 

(a) * * * 

(8) Ensure that, when telemedicine 

services are furnished to the hospital’s 

patients through an agreement with a 

distant-site (as defined in section 

1834(m)(4)(A) of the Act) hospital, the 

agreement specifies that it is the 

responsibility of the governing body of 

the distant-site hospital to meet the 

requirements in paragraphs (a)(1) 

through (a)(7) of this section with regard 

to its physicians and practitioners 

providing telemedicine services. The 

governing body of the hospital whose 

patients are receiving the telemedicine 

services may, in accordance with 

§ 482.22(a)(3), grant privileges based on 

its medical staff recommendations that 

rely on information provided by the 

distant-site hospital. 

* * * * * 

Subpart C—Basic Hospital Functions 

3. Section 482.22 is amended by— 

A. Adding a new paragraph (a)(3). 

B. Revising paragraph (c)(6). 

The addition and revision read as 

follows: 

§ 482.22 Condition of participation: 

Medical staff. 

* * * * * 

(a) * * * 

(3) When telemedicine services are 

furnished to the hospital’s patients 

through an agreement with a distant-site 

(as defined at section 1834(m)(4)(A) of 

the Act) hospital, the governing body of 

the hospital whose patients are 

receiving the telemedicine services may 

choose, in lieu of the requirements in 

paragraphs (a)(1) and (a)(2) of this 

section, to have its medical staff rely 

upon information furnished by the 

distant-site hospital when making 

recommendations on privileges for the 

individual distant-site physicians and 

practitioners providing such services, if 

the hospital’s governing body ensures 

that all of the following provisions are 

met: 

(i) The distant-site hospital providing 

the telemedicine services is a Medicareparticipating hospital. 

(ii) The individual distant-site 

physician or practitioner is privileged at 

the distant-site hospital providing the 

telemedicine services, which provides a 

current list of the distant-site 

physician’s or practitioner’s privileges. 

(iii) The individual distant-site 

physician or practitioner holds a license 

issued or recognized by the State in 

which the hospital, whose patients are 

receiving the telemedicine services, is 

located. 

(iv) With respect to a distant-site 

physician or practitioner granted 

privileges, the hospital, whose patients 

are receiving the telemedicine services, 

has evidence of an internal review of the 

distant-site physician’s or practitioner’s 

performance of these privileges and 

sends the distant-site hospital such 

performance information for use in the 

periodic appraisal of the distant-site 

physician or practitioner. At a 

minimum, this information must 

include all adverse events that result 

from the telemedicine services provided 

by the distant-site physician or 

practitioner to the hospital’s patients 

and all complaints the hospital has 

received about the distant-site physician 

or practitioner. 

* * * * * 

(c) * * * 

(6) Include criteria for determining 

the privileges to be granted to 

individual practitioners and a procedure 

for applying the criteria to individuals 

requesting privileges. For distant-site 

physicians and practitioners requesting 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 29487 

privileges to furnish telemedicine 

services under an agreement with the 

hospital, the criteria for determining 

privileges and the procedure for 

applying the criteria are also subject to 

the requirements in § 482.12(a)(8) and 

§ 482.22(a)(3). 

* * * * * 

PART 485—CONDITIONS OF 

PARTICIPATION: SPECIALIZED 

PROVIDERS 

4. The authority citation for part 485 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)). 

Subpart F—Conditions of 

Participation: Critical Access Hospitals 

(CAHs) 

5. Section 485.616 is amended by 

adding a new paragraph (c) to read as 

follows: 

§ 485.616 Condition of participation: 

Agreements. 

* * * * * 

(c) Standard: Agreements for 

credentialing and privileging of 

telemedicine physicians and 

practitioners. (1) The governing body of 

the CAH must ensure that, when 

telemedicine services are furnished to 

the CAH’s patients through an 

agreement with a distant-site (as defined 

at section 1834(m)(4)(A) of the Act) 

hospital, the agreement specifies that it 

is the responsibility of the governing 

body of the distant-site hospital to meet 

the following requirements with regard 

to its physicians or practitioners 

providing telemedicine services: 

(i) Determine, in accordance with 

State law, which categories of 

practitioners are eligible candidates for 

appointment to the medical staff. 

(ii) Appoint members of the medical 

staff after considering the 

recommendations of the existing 

members of the medical staff. 

(iii) Assure that the medical staff has 

bylaws. 

(iv) Approve medical staff bylaws and 

other medical staff rules and 

regulations. 

(v) Ensure that the medical staff is 

accountable to the governing body for 

the quality of care provided to patients. 

(vi) Ensure the criteria for selection 

are individual character, competence, 

training, experience, and judgment. 

(vii) Ensure that under no 

circumstances is the accordance of staff 

membership or professional privileges 

in the hospital dependent solely upon 

certification, fellowship or membership 

in a specialty body or society. 

(2) When telemedicine services are 

furnished to the CAH’s patients through 

an agreement with a distant-site (as 

defined at section 1834(m)(4)(A) of the 

Act) hospital, the CAH’s governing body 

or responsible individual may choose to 

rely upon the credentialing and 

privileging decisions made by the 

governing body of the distant-site 

hospital regarding individual distantsite physicians or practitioners. The 

CAH’s governing body or responsible 

individual must ensure that the 

following provisions are met: 

(i) The distant-site hospital providing 

telemedicine services is a Medicareparticipating hospital. 

(ii) The individual distant-site 

physician or practitioner is privileged at 

the distant-site hospital providing the 

telemedicine services, which provides a 

current list of the distant-site 

physician’s or practitioner’s privileges; 

(iii) The individual distant-site 

physician or practitioner holds a license 

issued or recognized by the State in 

which the CAH is located; and 

(iv) With respect to a distant-site 

physician or practitioner granted 

privileges by the CAH, the CAH has 

evidence of an internal review of the 

distant-site physician’s or practitioner’s 

performance of these privileges and 

sends the distant-site hospital such 

information for use in the periodic 

appraisal of the individual distant-site 

physician or practitioner. At a 

minimum, this information must 

include all adverse events that result 

from the telemedicine services provided 

by the distant-site physician or 

practitioner to the CAH’s patients and 

all complaints the CAH has received 

about the distant-site physician or 

practitioner. 

6. Section 485.641 is amended by— 

A. Republishing paragraph (b)(4)(i). 

B. Revising paragraphs (b)(4)(ii) and 

(iii). 

C. Adding a new paragraph (b)(4)(iv). 

The additions and revisions read as 

follows: 

§ 485.641 Condition of participation: 

Periodic evaluation and quality assurance 

review 

* * * * * 

(b) * * * 

(4) The quality and appropriateness of 

the diagnosis and treatment furnished 

by doctors of medicine or osteopathy at 

the CAH are evaluated by— 

(i) One hospital that is a member of 

the network, when applicable; 

(ii) One QIO or equivalent entity; 

(iii) One other appropriate and 

qualified entity identified in the State 

rural health care plan; or 

(iv) In the case of distant-site 

physicians and practitioners providing 

telemedicine services to the CAH’s 

patients under an agreement between 

the CAH and a distant-site (as defined 

at section 1834(m)(4)(A) of the Act) 

hospital, the distant-site hospital. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program). (Catalog of Federal 

Domestic Assistance Program No. 93.778, 

Medical Assistance Program) 

Dated: May 20, 2010. 

Marilyn Tavenner, 

Acting Administrator and Chief Operating 

Officer, Centers for Medicare & Medicaid 

Services. 

Approved: May 21, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–12647 Filed 5–21–10; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 578 

[Docket No. NHTSA–2010–0066] 

Reports, Forms and Record Keeping 

Requirements, Agency Information 

Collection Activity Under OMB Review 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), DOT. 

ACTION: Notice of proposed extension, 

without change, of a currently approved 

collection of information. 

SUMMARY: Before a Federal agency can 

collect certain information from the 

public, the agency must receive 

approval from the Office of Management 

and Budget (‘‘OMB’’). Under procedures 

established by the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.), 

before seeking OMB approval, Federal 

agencies must solicit public comment 

on proposed collections of information, 

including extensions and reinstatements 

of previously approved collections. In 

compliance with the Paperwork 

Reduction Act of 1995, this notice 

describes one collection of information 

for which NHTSA intends to seek OMB 

approval. 

DATES: Comments must be submitted on 

or before July 26, 2010. 

ADDRESSES: You may submit comments 

to the docket number identified in the 

heading of this document by any of the 

following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1