[Federal Register Volume 75, Number 101 (Wednesday, May 26, 2010)]
[Proposed Rules]
[Pages 29479-29487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12647]
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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.
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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
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is http://www.gpoaccess.gov/index.html), by using local WAIS client
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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).
[[Page 29480]]
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 in-person 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 on-
site.
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 TJC-accredited facility. Hospitals
that have used this method to privilege distant-site 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 long-standing 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 Medicare-participating 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
[[Page 29481]]
hospital based on evaluation of the practitioner's medical competency.
Hospital CoPs (Sec. 482.12 and Sec. 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: Sec. 482.12, ``Governing body,''
and Sec. 482.22, ``Medical staff.''
For the Governing body CoP, we are proposing to add a new
paragraph, Sec. 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 Medicare-
participating 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 (Sec. 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
distant-site 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 Sec.
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
Sec. 482.12(a)(8) and Sec. 482.22(a)(3).
Critical Access Hospital (CAH) CoPs (Sec. 485.616 and Sec. 485.641)
The proposed revisions to the CAH CoPs are found at Sec. 485.616,
``Agreements,'' and Sec. 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 Sec. 485.616(c). We are
proposing to add a new standard at Sec. 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 Sec. 482.12(a).
This language delineates the responsibilities of the governing body for
the medical staff privileging process.
At Sec. 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.
[[Page 29482]]
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 (Sec.
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 (Sec.
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 Sec.
482.22(a)(3)(i) through (iv) are met. Specifically, Sec.
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 third-party disclosure requirement
would be the time and effort necessary for a hospital 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 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 (Sec.
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 Sec. 485.616(c)(1)(i) through (vii) and Sec. 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 Sec. 485.616(c)(2)(i) through (iv) are met. The
burden associated with this third-party disclosure requirement at Sec.
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 $1,248.
[[Page 29483]]
Table 1--Annual Reporting and Recordkeeping Burden
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Hourly
Burden per Total labor cost Total labor Total
Regulation section(s) OMB control Respondents Responses response annual of cost of capital/ Total cost
No. (hours) burden reporting reporting maintenance ($)
(hours) ($) ($) costs ($)
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Sec. 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
Sec. 482.22(a)(3)............................................... 0938-New 4,860 155,520 1 155,520 39 6,065,280 0 6,065,280
Sec. 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
Sec. 485.616(c)(2).............................................. 0938-New 1,314 42,048 1 42,048 39 1,639,872 0 1,639,872
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Total......................................................... ............ 6,174 209,916 ............ 382,788 ............ ............ ............ ............
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** 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.
[[Page 29484]]
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 third-party 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:
[[Page 29485]]
Table 2--Information Collection Requirements for a Hospital to Develop an Agreement for Telemedicine Services:
Initial Cost
----------------------------------------------------------------------------------------------------------------
Hourly Number of Cost per
Individual wage hours 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
----------------------------------------------------------------------------------------------------------------
Hourly Number of Cost per
Individual wage hours 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
----------------------------------------------------------------------------------------------------------------
Hourly Number of Cost per
Individual wage hours 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
----------------------------------------------------------------------------------------------------------------
Hourly Number of Cost per
Individual wage hours 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
----------------------------------------------------------------------------------------------------------------
Hourly Number of Cost per
Individual wage hours 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
----------------------------------------------------------------------------------------------------------------
Hourly Number of Cost per
Individual wage hours 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.
[[Page 29486]]
Table 8--Information Collection Requirements for a Hospital To Prepare and Send Individual Performance Reviews
for Telemedicine Services (Third-Party Disclosure): Annual Cost
----------------------------------------------------------------------------------------------------------------
Hourly Number of Cost per
Individual wage hours individual Total cost
----------------------------------------------------------------------------------------------------------------
Medical Staff Coordinator or Medical Staff Credentialing $39 32 $1,248 $1,248
Manager....................................................
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Cost per
Individual Hourly wage hours individual Total cost
----------------------------------------------------------------------------------------------------------------
Medical Staff Coordinator or Medical Staff Credentialing $39 32 $1248 $1248
Manager....................................................
----------------------------------------------------------------------------------------------------------------
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:
Sec. 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 Sec. 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:
Sec. 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 Medicare-participating 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
[[Page 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 Sec.
482.12(a)(8) and Sec. 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:
Sec. 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 distant-site 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
Medicare-participating 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:
Sec. 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