WWW.KENNEDYCOVINGTON.COM
H E A LT H L A W
NEWS
Proposed Changes to Independent Diagnostic
Testing Facility Performance Standards
August 2007
On July 12, 2007 the Centers for Medicare and Medicaid
Services ("CMS") published its Medicare Physician Fee Schedule
proposed rule for 2008 in the Federal Register ("Proposed
Rule").
Included within the Proposed Rule are proposed
changes to the CMS Independent Diagnostic Testing Facility
("IDTF") standards, all of which, if adopted, would:
Founded in 1957, Kennedy Covington is one
of the largest law firms in the Carolinas with
offices in Charlotte, Raleigh, Research
Triangle Park, Columbia and Rock Hill. Our
more than 200 attorneys use their diverse
experience and knowledge to counsel
clients in varied industries such as banking
and finance, real estate, technology and
manufacturing. At Kennedy Covington, we
give more than a legal opinion; we provide
a business perspective.
·
Add a new standard prohibiting an IDTF from sharing space,
equipment or staff or subleasing its operations to another
individual or organization.
·
Add a new standard which establishes the billing privileges
of a newly enrolled IDTF as the later of the filing date of the
enrollment application or the date the IDTF first furnished
services at its new practice location.
·
Delete the requirement that the supervising physician be
responsible for the overall operation and administration of
the IDTF, including the employment of personnel and assuring compliance with applicable regulations. According to
CMS, it never intended to shift the overall administrative
responsibility to the supervising physician and clarifies its
position with the proposed change.
·
Extend the timeframe from 30 to 90 days for reporting
enrollment updates for changes other than changes in ownership ("CHOW"), changes of location, changes in general
supervision and adverse legal actions. Reporting of CHOWs,
location, supervision and adverse legal actions would continue to be required within 30 days.
·
Require the provider list the CMS contractor as a Certificate
Holder on its insurance policy so that the contractor can verify compliance with the insurance standard and would clarify that failure to meet the insurance standard would result in
revocation of Medicare billing privileges from the date the
insurance lapses.
This newsletter is published as a service to
clients and others interested in health law
issues. The information provided herein is
general in nature and should not be relied
upon as legal advice as to specific factual
situations. Our health law practice group
welcomes your comments or inquiries about
this newsletter or about any specific matters you may wish to discuss with us.
Health Law Practice Group
Gina L. Bertolini
Tate M. Bombard
Richard P. Church
Colleen M. Crowley
Amy O. Garrigues
Mary Beth Johnston
Patricia T. Meador
Carolyn F. Merritt
Mayelin Prieto-Gonzalez
Gary S. Qualls
Patrick J. Togni
Kathy G. Barger (Consultant)
Carol E. Jones (Consultant)
919.466.1195
919.466.1125
919.466.1187
919.466.1189
919.466.1275
919.466.1181
919.466.1180
919.466.1246
919.466.1126
919.466.1182
919.466.1249
919.466.1185
919.466.1250
·
Require that the IDTF document each beneficiary complaint and the IDTF's response to each complaint and store such documentation at the IDTF site.
The most controversial of the proposed changes is likely to be the prohibition against IDTFs sharing space,
equipment or staff or subleasing its operations to another individual or organization. Currently IDTFs must
maintain a physical facility; however, the new standard would prohibit a fixed-based IDTF from sharing or
subleasing space.
Below is a summary of the proposed revisions to existing IDTF performance standards, proposed new IDTF
standards, and comments explaining the proposed change and/or noting information included in the commentary to the Proposed Rule. Note that current IDTF standards without proposed changes are not included in the summary table. CMS will consider comments regarding the Proposed Rule if received no later than
5 p.m. on Friday, August, 31, 2007. Comments should include the caption "IDTF ISSUES."
If you have any questions regarding the matters discussed in this advisory, please contact either:
Kathy G. Barger1
919.466.1185
kbarger@kennedycovington.com
Mary Beth Johnston
919.466.1181
mjohnston@kennedycovington.com
42 CFR
§410.33
Current Regulation
(regulations with proposed changes are
noted)
Proposed Regulation Changes
(comments in italics)
(b) Supervising
Physician.
(1) Each supervising physician must be
limited to providing supervision to no
more than three IDTF sites. The IDTF
supervising physician is responsible
for the overall operation and administration of the IDTFs, including the
employment of personnel who are
competent to perform test procedures,
record and report test results promptly,
accurately and proficiently, and for
assuring compliance with the applicable regulations.
Replaces (b)(1) with:
1Healthcare Consultant. Not licensed to practice law.
(1) Each supervising physician must be limited to providing supervision to no more
than three IDTF sites. This applies to
both fixed sites and mobile units where
three concurrent operations are capable
of performing tests.
The Proposed Rule deletes the requirement that the
supervising physician be responsible for the overall
operation and administration of the IDTFs, including
the employment of personnel and assuring compliance with applicable regulations. CMS believes that
this earlier rulemaking effort had the unintended consequence of appearing to shift the overall administrative responsibility from the owners or administrative
staff to the supervising physician. The proposed rule
also clarifies and expands CMS' meaning of what
constitutes three IDTF sites to include both fixed
sites and mobile units which can concurrently run
diagnostic tests. This clarification does not change the
direct and personal supervision requirements for
diagnostic tests found at §410.32(b)(3).
42 CFR
§410.33
Current Regulation
(regulations with proposed changes are
noted)
Proposed Regulation Changes
(comments in italics)
(g) Application
of
certification standards.
The IDTF must certify in its enrollment applica- Sections proposed as replacements:
tion that it meets the following standards and
related requirements:
*****
2) Provides complete and accurate information on its enrollment application.
Any change in enrollment information
must be reported to the designated feefor-service contractor on the Medicare
enrollment application within 30 calendar days of the change.
2) Provides complete and accurate information on its enrollment application.
Changes in ownership, changes of location, changes in general supervision, and
adverse legal actions must be reported to
the designated fee-for-service contractor
on the Medicare enrollment application
within 30 calendar days of the change. All
other changes to the enrollment application must be reported within 90 days.
CMS distinguishes between critical changes and
updates to IDTF information and applies different
deadlines.
6) Have a comprehensive liability insurance policy of at least $300,000 per location that covers both the place of business and all customers and employees
of the IDTF. The policy must be carried
by a nonrelative-owned company.
6) Have a comprehensive liability insurance
policy of at least $300,000 per location that
covers both the place of business and all
customers and employees of the IDTF.
The policy must be carried by a nonrelative-owned company. Failure to maintain
required insurance at all times will result
in revocation of the IDTF's billing privileges retroactive to the date the insurance
lapsed. IDTF suppliers are responsible for
providing the contact information for the
issuing insurance agent and the underwriter. In addition, the IDTF must - (i)
Ensure that the insurance policy must
remain in force at all times and provide
coverage of at least $300,000 per incident;
(ii) Notify the CMS designated contractor
in writing if any policy changes or cancellations; and (iii) List the CMS designated
contractor as a Certificate Holder on the
policy.
The proposed rule clarifies how CMS will verify
whether an IDTF meets the standard. In the commentary to the rule, CMS notes that the proposed
change will not preclude the use of self insurance as
long as CMS or its contractor can verify the policy
and coverage provisions with an independent underwriter. CMS encourages IDTFs to obtain comprehensive liability insurance coverage at least 90 days
prior to filing its Medicare enrollment application in
order to prevent delays in the enrollment process.
CMS also notes in the commentary that by listing the
CMS contractor as a Certificate Holder on the policy,
the contractor will be able to verify coverage with the
underwriter at the time of enrollment and as the need
arises throughout the year.
42 CFR
§410.33
Current Regulation
(regulations with proposed changes are
noted)
Proposed Regulation Changes
(comments in italics)
(g) Application
of
certification standards.
8) Answer beneficiaries' questions and
respond to their complaints.
8) Answer, document, and maintain documentation of all beneficiaries' questions
and responses to their complaints at the
physical site of the IDTF. This includes,
but is not limited to, the following: (i) The
name, address, telephone number, and
health insurance claim number of the beneficiary. (ii) A summary of the complaint;
the date it was received; the name of the
person receiving the complaint; and a
summary of actions taken to resolve the
complaint. (iii) If an investigation was not
conducted, the name of the person making the decision and the reason for the
decision. For mobile IDTFs, this documentation would be stored at their home
office.
CMS notes in the commentary to the proposed rule
that the change corrects an oversight in drafting of the
initial performance standards, which did not require
that the IDTF document its complaint process.
Section proposed as an addition:
15) Does not share space, equipment or staff
or sublease it operations to another individual or organization.
As justification for this new standard, CMS notes in
the commentary that it believes that it is inappropriate for a fixed-based (physical site) IDTF to commingle office space (including waiting rooms), staff
(including supervising physicians, nonphysician personnel, or receptionists), or equipment and that
doing such constitutes a significant risk to the
Medicare program because it prohibits CMS or its
contractors from ensuring that each fixed-based IDTF
establishes and maintains Medicare billing privileges
consistent with Medicare requirements. The commentary states that this performance standard along
with the standard that an IDTF must maintain a
physical facility on an appropriate site
[§410.33(g)(3)], means that a motel or hotel is not an
appropriate site for an IDTF. Also, CMS is seeking
comments as to whether this new standard should
apply to mobile IDTFs as well as fixed-based IDTFs.
42 CFR
§410.33
Current Regulation
(regulations with proposed changes are
noted)
Proposed Regulation Changes
(comments in italics)
(i) Effective date of
billing privileges.
No current regulation.
The effective date of billing privileges for a
newly enrolled IDTF is the later of the following:
(1) The filing date of the Medicare enrollment
application that was subsequently
approved by a fee-for-service contractor;
(2) The date the IDTF first furnished services
at its new practice location; or
(3) The filing date of the Medicare enrollment
application is the date that the Medicare
fee-for-service contractor receives a
signed provider enrollment application
that it is able to process for approval.
Medicare is concerned that allowing an IDTF to bill
for services furnished prior to enrolling in the
Medicare program allows these facilities to potentially be reimbursed for services they are not qualified to
perform or otherwise are precluded from billing.
CMS states that this approach is consistent with
existing requirements for providers that require a
State survey prior to enrollment.
Kennedy Covington
Hearst Tower, 47th Floor
214 North Tryon Street
Charlotte, NC 28202
www.kennedycovington.com
Notice: This communication (including any attachment) is being sent on behalf of Kennedy Covington and may be considered a "commercial mail message" for purposes of the CAN-SPAM Act.
© Copyright 2007 Kennedy Covington