Business address
131 Continental Drive, Suite 405
Newark, Delaware 19713
Phone: 302-658-7596  Fax: 302-658-9669  asdin@medsocdel.org
www.asdin.org
American Society of Diagnostic
& Interventional Nephrology
SEMINARS IN DIALYSIS Is the Official Journal of the American
Society of Diagnostic and Interventional Nephrology
President
Theodore F. Saad, M.D.
Wilmington, Delaware
President elect
Arif Asif, M.D.
Miami, Florida
Past-president
Jack Work, M.D.
Atlanta, Georgia
Secretary-treasurer
Timothy A. Pflederer, M.D.
Morton, Illinois
Chairman, certification
Gerald Beathard, M.D.
Austin, Texas
Councilors
Hemodialysis access
Michael Levine, M.D.
Milwaukee, Wisconsin
Peritoneal catheters
Kenneth Abreo, M.D.
Shreveport, Louisiana
Hemodialysis catheters
Tom Vesely, M.D.
St. Louis, Missouri
Access surveillance
Tony Besarab, M.D.
Detroit, Michigan
Ultrasound & biopsy
Linda Francisco, M.D.
Wichita, Kansas
Regulatory &
reimbursement
Don Schon, M.D.
Phoenix, Arizona
Education &
Programs
Rick Mishler, M.D.
Phoenix, Arizona
Associate membership
Terry Litchfield, M.P.A.
Riverwoods, Illinois
ASDIN Members & Colleagues,
Over the past several months, there have been numerous regulatory and legislative
proposals with very important implications for the delivery of optimal vascular access care
to patients with end-stage renal disease. During this time, the ASDIN leadership has been
working diligently to study these proposals, and has collaborated with the Renal
Physicians Association (RPA) and other interested parties to help formulate appropriate
responses to CMS and our legislators. The purposes of this letter are to inform and update
our membership on the status of these proposals, describe their potential impact on
vascular access care in the United States, and suggest actions which each member may
take now in order to help achieve the most appropriate disposition of these proposals, both
in the immediate and long-term.
There is potential for considerable confusion and miscommunication about these arcane
reimbursement matters. In this case, matters are compounded by the fact that there are
both legislative and regulatory processes involved, a critical distinction which may at
times appear blurred. Furthermore, the services of interest are provided by physicians
working in hospitals, office-based “access centers,” and ambulatory surgery centers
(ASC), each of which will be very differently impacted by any particular law or regulation.
So in the following summary, I have taken pains to make these distinctions as clear as
possible. Most of the immediate comments apply to the “access center” situation.
However, it is not our intention to promote this one model. The goal of the ASDIN is to
help all of our members achieve the best possible dialysis access outcomes for their
patients. In the process, we strive to promote rational public policy that make it feasible to
provide cost-effective, high quality care in whatever practice setting is most appropriate
for that individual practice and community. For those members who are not interested in
all these tedious details, please just skip to the end and follow the “Instructions for
Member Action.”
The genesis of these recent CMS proposed rule changes was legislation passed by
Congress last year, known as the “Deficit Reduction Act (DRA) of 20051.” This act
mandated CMS to “reduce payment for multiple imaging services,” primarily by capping
the technical component of payments for imaging services performed in a doctor’s office.
Although the language in this bill appears to “target” primarily outpatient radiographic
imaging facilities, it applies to all radiographic imaging performed in any outpatient
“office” practice (including outpatient office-based “access centers”). It should be noted
that this particular legislation and associated regulatory changes do not apply to hospitalbased or ambulatory surgery center practice.
Seminars in dialysis
editors
Stephen Ash, M.D.
Lafayette, Indiana
Arif Asif, M.D.
Miami, Florida
1
Executive director
Dianna M. Garvey
Newark, Delaware
1
www.cbo.gov/ftpdocs/70xx/doc7028/s1932conf.pdf
In order to implement this legislative mandate, CMS has published two proposed rule changes:
 On June 29 2006, proposed notice CMS1512-PN2 outlined changes in Relative Value Units (RVU)
and Practice Expense Methodology (PE) with associated 2007 fee schedule changes imposing
significant reductions in physician payment for a wide variety of services, including dialysis access
procedures. The public comment period for this regulation closed on August 21, 2006.
Comments against the adoption of this regulation were submitted on behalf of the ASDIN by our
Regulatory Affairs Councilor, as well as other members and partners; nevertheless, it was adopted
without significant alteration.
 Subsequently, proposed rule CMS1321-P3 was issued on August 22, 2006. This outlines the methods
for achieving reduced payment for multiple imaging services and as written, will become effective
January 1, 2007. The public comment period for this regulation remains open through October
10, 2006. These proposed changes have been met with considerable resistance from a number of
vocal and powerful constituents, most notably the radiologic societies, and efforts are being made to
delay the implementation or mitigate the impact of these rule changes. Formal comment to CMS is
being drafted and will be submitted on behalf of the ASDIN by Don Schon, Regulatory Affairs
Councilor. A draft of this will be made available to the membership when completed.
The combination of fee schedule reductions and reduced technical component payment for multiple imaging
procedures will have the immediate effect to reduce payments for outpatient office-based (i.e. “access center”)
interventional procedures by approximately 6-7% starting in January, 2007. Further programmed annual
reductions are estimated to result in total decrease of approximately 22-27% by 2010. The precise impact to
any practice will depend on their case-mix and other local RVU & PE calculation factors, but in any case, the
impact will be significant, if not critical. It is our opinion that these projected reductions in reimbursement for
dialysis access procedures are premature and ill-considered as they apply to vascular access procedures, and
counter to the stated goals of CMS to promote high-quality, cost-effective outpatient care, particularly in the
era of the “Fistula First” initiative. It is likely that these reimbursement reductions will stifle the development
of office-based access centers, and potentially result in a shift back to hospital-based access procedures.
Therefore, we are asking our members and partners to submit comments on proposed rule CMS1321-P. It
certainly appears that despite all comments, it is very likely that this rule will be implemented with little or no
revision. Nevertheless, we feel that it is essential to for our voices to be heard at CMS.
In an effort to avoid the immediate negative impact of these impending regulations, companion bills have been
introduced in both the House of Representatives and the Senate: House Resolution 57044, “Access to
Medicare Imaging Act of 2006,” and corresponding Senate Bill 37955 would in effect amend the DRA of
2005 and impose a 2-year moratorium on implementation of any CMS rule changes, pending completion of a
comprehensive study by the General Accounting Office on their potential impact, particularly pertaining to
quality and access to imaging services. The ASDIN and numerous other renal organizations (including RPA,
NKF) strongly support this legislation, which if passed will forestall these regulatory changes and allow us
time to work with policy-makers and help to develop more rational and effective future adjustments in
payment for dialysis access procedures, based on outcomes, quality, and cost-effectiveness data. We strongly
encourage our members and partners to support this important legislation by contacting their congressional
representatives as outlined below.
All of the above discussion applies primarily to physicians practicing in office-based imaging centers. There
are additional proposed regulations that apply to hospitals and ambulatory surgery centers which will have
significant implications for those physicians and practices currently providing vascular access services in these
settings, or for those who might be considering future conversion to an Ambulatory Surgery Center. The
pertinent proposed rule is: CMS-1506-P6: “Medicare Program; Proposed Changes to the Hospital
2
http://www.cms.hhs.gov/quarterlyproviderupdates/downloads/cms1512pn.pdf
www.cms.hhs.gov/quarterlyproviderUpdates/downloads/cms1321p.pdf
4
http://www.govtrack.us/data/us/bills.text/109/h/h5704.pdf
5
www.govtrack.us/data/us/bills.text/109/s/s3795.pdf
6
http://www.cms.hhs.gov/HospitalOutpatientPPS/Downloads/CMS1506P.pdf
3
Outpatient Prospective Payment System and CY 2007 Payment Rates; Proposed CY 2007 Update to the
Ambulatory Surgical Center Covered Procedures List; Proposed Changes to the Ambulatory Surgical
Center Payment System and CY 2008 Payment Rates; Medicare Administrative Contractors; and
Reporting Hospital Quality Data for FY 2008 Inpatient Prospective Payment System Annual Payment
Update.” The comment period for this extends to October 10, 2006. This is a very broad regulation, running
over 1000 pages and addressing multiple aspects of ASC-based care. This has been meticulously reviewed by
our Councilor for Regulatory Affairs, and by Terry Litchfield, Councilor for Associate Member Affairs. Terry
has also working directly with the Foundation for Ambulatory Surgery in America (FASA: www.fasa.org) to
analyze and respond to this proposed rule. Don Schon has prepared a detailed response to CMS and this will
be submitted as a comment on behalf of ASDIN shortly. A draft copy of this is attached for member review
and comment.
There are both beneficial and detrimental aspects to this proposed rule. One of the stated goals of this
regulation is to modify the system for determining whether procedures are eligible to be performed in an ASC;
this would replace the current list of “Approved Procedures” and instead create a list of “Excluded
Procedures,” theoretically expanding the eligible procedure codes. CMS also has the stated goal of
discouraging physicians from moving current office-based procedures to ASC’s, or “inappropriately
converting” current office-practice facilities to ASC’s in order to gain higher reimbursement for these
procedures (XVIII.C.5, page 463)6. In order to mitigate this potential, CMS is proposing to cap payments for
“office-based procedures” performed in an ASC to be no greater than the payment for that procedure
performed in an office-based facility. In short, the major implications to physicians providing dialysis access
interventional services in an ASC are the following:

Certain essential procedure codes are added to the “ASC approved list” (Table 41, page 398)6
including 35476 (venous angioplasty), 37205 (intravascular stent placement)
ASDIN Members & Colleagues,
Over the past several months, there have been numerous regulatory and legislative proposals with very
important implications for the delivery of optimal vascular access care to patients with end-stage renal disease.
During this time, the ASDIN leadership has been working diligently to study these proposals, and has
collaborated with the Renal Physicians Association (RPA) and other interested parties to help formulate
appropriate responses to CMS and our legislators. The purposes of this letter are to inform and update our
membership on the status of these proposals, describe their potential impact on vascular access care in the
United States, and suggest actions which each member may take now in order to help achieve the most
appropriate disposition of these proposals, both in the immediate and long-term.
There is potential for considerable confusion and miscommunication about these arcane reimbursement
matters. In this case, matters are compounded by the fact that there are both legislative and regulatory
processes involved, a critical distinction which may at times appear blurred. Furthermore, the services of
interest are provided by physicians working in hospitals, office-based “access centers,” and ambulatory surgery
centers (ASC), each of which will be very differently impacted by any particular law or regulation. So in the
following summary, I have taken pains to make these distinctions as clear as possible. Most of the immediate
comments apply to the “access center” situation. However, it is not our intention to promote this one model.
The goal of the ASDIN is to help all of our members achieve the best possible dialysis access outcomes for
their patients. In the process, we strive to promote rational public policy that make it feasible to provide costeffective, high quality care in whatever practice setting is most appropriate for that individual practice and
community. For those members who are not interested in all these tedious details, please just skip to the end
and follow the “Instructions for Member Action.”
The genesis of these recent CMS proposed rule changes was legislation passed by Congress last year, known
as the “Deficit Reduction Act (DRA) of 20057.” This act mandated CMS to “reduce payment for multiple
imaging services,” primarily by capping the technical component of payments for imaging services performed
in a doctor’s office. Although the language in this bill appears to “target” primarily outpatient radiographic
imaging facilities, it applies to all radiographic imaging performed in any outpatient “office” practice
7
www.cbo.gov/ftpdocs/70xx/doc7028/s1932conf.pdf
(including outpatient office-based “access centers”). It should be noted that this particular legislation and
associated regulatory changes do not apply to hospital-based or ambulatory surgery center practice.
In order to implement this legislative mandate, CMS has published two proposed rule changes:
 On June 29 2006, proposed notice CMS1512-PN8 outlined changes in Relative Value Units (RVU)
and Practice Expense Methodology (PE) with associated 2007 fee schedule changes imposing
significant reductions in physician payment for a wide variety of services, including dialysis access
procedures. The public comment period for this regulation closed on August 21, 2006.
Comments against the adoption of this regulation were submitted on behalf of the ASDIN by our
Regulatory Affairs Councilor, as well as other members and partners; nevertheless, it was adopted
without significant alteration.
 Subsequently, proposed rule CMS1321-P9 was issued on August 22, 2006. This outlines the methods
for achieving reduced payment for multiple imaging services and as written, will become effective
January 1, 2007. The public comment period for this regulation remains open through October
10, 2006. These proposed changes have been met with considerable resistance from a number of
vocal and powerful constituents, most notably the radiologic societies, and efforts are being made to
delay the implementation or mitigate the impact of these rule changes. Formal comment to CMS is
being drafted and will be submitted on behalf of the ASDIN by Don Schon, Regulatory Affairs
Councilor. A draft of this will be made available to the membership when completed.
The combination of fee schedule reductions and reduced technical component payment for multiple imaging
procedures will have the immediate effect to reduce payments for outpatient office-based (i.e. “access center”)
interventional procedures by approximately 6-7% starting in January, 2007. Further programmed annual
reductions are estimated to result in total decrease of approximately 22-27% by 2010. The precise impact to
any practice will depend on their case-mix and other local RVU & PE calculation factors, but in any case, the
impact will be significant, if not critical. It is our opinion that these projected reductions in reimbursement for
dialysis access procedures are premature and ill-considered as they apply to vascular access procedures, and
counter to the stated goals of CMS to promote high-quality, cost-effective outpatient care, particularly in the
era of the “Fistula First” initiative. It is likely that these reimbursement reductions will stifle the development
of office-based access centers, and potentially result in a shift back to hospital-based access procedures.
Therefore, we are asking our members and partners to submit comments on proposed rule CMS1321-P. It
certainly appears that despite all comments, it is very likely that this rule will be implemented with little or no
revision. Nevertheless, we feel that it is essential to for our voices to be heard at CMS.
In an effort to avoid the immediate negative impact of these impending regulations, companion bills have been
introduced in both the House of Representatives and the Senate: House Resolution 570410, “Access to
Medicare Imaging Act of 2006,” and corresponding Senate Bill 379511 would in effect amend the DRA of
2005 and impose a 2-year moratorium on implementation of any CMS rule changes, pending completion of a
comprehensive study by the General Accounting Office on their potential impact, particularly pertaining to
quality and access to imaging services. The ASDIN and numerous other renal organizations (including RPA,
NKF) strongly support this legislation, which if passed will forestall these regulatory changes and allow us
time to work with policy-makers and help to develop more rational and effective future adjustments in
payment for dialysis access procedures, based on outcomes, quality, and cost-effectiveness data. We strongly
encourage our members and partners to support this important legislation by contacting their congressional
representatives as outlined below.
All of the above discussion applies primarily to physicians practicing in office-based imaging centers. There
are additional proposed regulations that apply to hospitals and ambulatory surgery centers which will have
significant implications for those physicians and practices currently providing vascular access services in these
settings, or for those who might be considering future conversion to an Ambulatory Surgery Center. The
8
http://www.cms.hhs.gov/quarterlyproviderupdates/downloads/cms1512pn.pdf
www.cms.hhs.gov/quarterlyproviderUpdates/downloads/cms1321p.pdf
10
http://www.govtrack.us/data/us/bills.text/109/h/h5704.pdf
11
www.govtrack.us/data/us/bills.text/109/s/s3795.pdf
9
pertinent proposed rule is: CMS-1506-P12: “Medicare Program; Proposed Changes to the Hospital
Outpatient Prospective Payment System and CY 2007 Payment Rates; Proposed CY 2007 Update to the
Ambulatory Surgical Center Covered Procedures List; Proposed Changes to the Ambulatory Surgical
Center Payment System and CY 2008 Payment Rates; Medicare Administrative Contractors; and
Reporting Hospital Quality Data for FY 2008 Inpatient Prospective Payment System Annual Payment
Update.” The comment period for this extends to October 10, 2006. This is a very broad regulation, running
over 1000 pages and addressing multiple aspects of ASC-based care. This has been meticulously reviewed by
our Councilor for Regulatory Affairs, and by Terry Litchfield, Councilor for Associate Member Affairs. Terry
has also working directly with the Foundation for Ambulatory Surgery in America (FASA: www.fasa.org) to
analyze and respond to this proposed rule. Don Schon has prepared a detailed response to CMS and this will
be submitted as a comment on behalf of ASDIN shortly. A draft copy of this is attached for member review
and comment.
There are both beneficial and detrimental aspects to this proposed rule. One of the stated goals of this
regulation is to modify the system for determining whether procedures are eligible to be performed in an ASC;
this would replace the current list of “Approved Procedures” and instead create a list of “Excluded
Procedures,” theoretically expanding the eligible procedure codes. CMS also has the stated goal of
discouraging physicians from moving current office-based procedures to ASC’s, or “inappropriately
converting” current office-practice facilities to ASC’s in order to gain higher reimbursement for these
procedures (XVIII.C.5, page 463)6. In order to mitigate this potential, CMS is proposing to cap payments for
“office-based procedures” performed in an ASC to be no greater than the payment for that procedure
performed in an office-based facility. In short, the major implications to physicians providing dialysis access
interventional services in an ASC are the following:

Certain essential procedure codes are added to the “ASC approved list” (Table 41, page 398)6
including 35476 (venous angioplasty), 37205 (intravascular stent placement)

There is inconsistency over procedure code 37206 (additional intravascular stent) which is included in
the list of ASC approved codes, but also listed as an excluded code (Table 45, page 448)6

Other essential procedure codes remain excluded from the approved list, including 35475 (arterial
angioplasty)

Previously excluded 70000 series Radiologic “Supervision and Interpretation” codes are included for
reimbursement in the ASC setting

ASC reimbursement will be capped at a percentage of hospital outpatient department (HOPD) rates,
estimated to be approximately 62% for 2007

ASC reimbursement will be capped at no greater than payment for comparable procedures performed
in office practice setting
The net result of these proposed changes may improve enhance reimbursement relative to current inadequate
ASC rates. But it will maintain the irrational disadvantage of ASC’s versus office-based “access centers” for
provision of these services, and discourage further development of ASC-based dialysis access interventional
practice.
I believe that as a Society, and as individual practicing interventional nephrologists, we should support
prudent and rational changes in CMS regulations and reimbursement policies. To this end, we need to
continue to work constructively with CMS as we have in the past, to educate and inform policymakers. We
also very much need to generate additional data to further demonstrate the safety, quality, and costeffectiveness of dialysis access procedures performed in a variety of non-hospital settings.
The next critical step is for all our ASDIN Members, Partners, and others with direct or indirect interest in
provision of dialysis access care to make our opinions clearly known to CMS and to our congresspersons. We
have attempted to make this as easy and painless as possible by providing all the relevant links and suggested
comments. A lot of time and effort has gone into this, and I am most grateful to all who have contributed,
particularly Don Schon and his staff, Gerald Beathard, Terry Litchfield, Rob Blazer, and many others. I ask
12
http://www.cms.hhs.gov/HospitalOutpatientPPS/Downloads/CMS1506P.pdf
that we all now take the few minutes necessary and make our collective voices heard. If anyone has any other
questions or ideas about these matters, as always, feel free to contact me, Don Schon, or the ASDIN office.
Respectfully Yours,
Theodore F. Saad, M.D.
President, American Society of Diagnostic & Interventional Nephrology
INSTRUCTIONS FOR MEMBER ACTION:
1. Identify your U.S. Congressional Representative by typing your zip code
into the following link: http://www.house.gov
 Go to your Representative’s website and find his/her mailing address
 Complete the attached sample letter requesting his/her support for
HR5704 & personalize it to fit your individual practice circumstances
 Print letter on your practice letterhead and mail to your Representative’s
local office
 In addition to mailing this letter, you may also choose to e-mail your
Representative via the link on their website
2. Identify your U.S. Senator from the “drop-down” menu in the following
link: http://www.senate.gov
 Go to both of your Senator’s websites and find their mailing addresses
 Complete the attached sample letter requesting his/her support for Senate
Bill 3796 and personalize it as necessary to fit your individual practice
circumstances
 Print letter on your practice letterhead and mail to your Senator’s local
office
 In addition to mailing this letter, you may also choose to e-mail your
Senator via the link on their website
3. Provide comments to CMS on proposed rules: Note that CMS does not
prefer to receive multiple identical “boilerplate” comments, which create an
administrative annoyance without additional tangible impact, so we are not
asking that detailed specific comments be submitted on these proposed rules.
We suggest a simple statement such as, “I support the position as outlined by
the American Society of Diagnostic and Interventional Nephrology (ASDIN).”
This will add weight to our comments as a Society.
 Follow this link to CMS http://www.cms.hhs.gov/eRulemaking/
 Click on link “Submit Electronic Comments on CMS Regulations with
an Open Comment Period.”. Submit comments on the following:
o 1321-P 10/10/2006
o 1321-P2 11/06/2006
o 1506-P 10/10/2006
HOUSE OF REPRESENTATIVES SAMPLE LETTER
On your letterhead.
DATE
Honorable HOUSE of REPRESENTATIVE'S NAME
United States House of Representatives
Washington, DC 20515
Dear Representative NAME:
I am writing to ask for your support of H.R. 5704, the Access to Medicare Imaging Act of 2006,
which is designed to mitigate the imaging reimbursement reductions set forth in Section 5102 of the
Deficit Reduction Act (S. 1932).
I am your constituent, a practicing physician specializing in interventional nephrology, and a leader
in outpatient vascular access care. I practice medicine at [institute -- describe it …number of
patients, employees, etc.] in [city] and have served there for the past ___years. In addition, my
practice operates an outpatient vascular access center in [city] which has successfully treated
[number patients] of your constituents over the last [number] years.
Interventional nephrology is one of the newest and most rapidly growing specialties in medicine.
We are on the leading edge of advances in imaging-guided minimally-invasive medicine.
Procedures performed by interventional nephrologist -- through small catheters and other devices
under radiological imaging -- are often less costly and significantly less invasive than alternative
surgical therapies.
Recently, in the context of Budget Reconciliation legislation, Congress unexpectedly took steps to
reduce reimbursement rates for medical imaging services. These actions will take effect on January
1, 2007. Because there was no hearing record (in either chamber of Congress) on this matter,
candidly, the consequence for patients is of high concern. There has been no analysis of the impact
this change in payment policy will have on Medicare beneficiaries’ access to care. It would be
unfortunate if a last-minute legislative action jeopardized patient safety in unforeseen ways.
In closing, thank you for considering this request to support H.R. 5704. It would be a great honor for
you or your appropriate staff member to tour my outpatient vascular access center. If I can further
assist your understanding of interventional nephrology, I would be delighted to do so.
Sincerely,
Your Name
Your Title
U.S. SENATE SAMPLE LETTER
On your letterhead.
DATE
Honorable SENATOR’S NAME
United States House of Representatives
Washington, DC 20515
Dear Senator NAME:
I am writing to ask for your support of Senate Bill 3795, the Access to Medicare Imaging Act of
2006, which is designed to mitigate the imaging reimbursement reductions set forth in Section 5102
of the Deficit Reduction Act (S. 1932).
I am your constituent, a practicing physician specializing in interventional nephrology, and a leader
in outpatient vascular access care. I practice medicine at [institute -- describe it …number of
patients, employees, etc.] in [city] and have served there for the past ___years. In addition, my
practice operates an outpatient vascular access center in [city] which has successfully treated
[number patients] of your constituents over the last [number] years.
Interventional nephrology is one of the newest and most rapidly growing specialties in medicine.
We are on the leading edge of advances in imaging-guided minimally-invasive medicine.
Procedures performed by interventional nephrologist -- through small catheters and other devices
under radiological imaging -- are often less costly and significantly less invasive than alternative
surgical therapies.
Recently, in the context of Budget Reconciliation legislation, Congress unexpectedly took steps to
reduce reimbursement rates for medical imaging services. These actions will take effect on January
1, 2007. Because there was no hearing record (in either chamber of Congress) on this matter,
candidly, the consequence for patients is of high concern. There has been no analysis of the impact
this change in payment policy will have on Medicare beneficiaries’ access to care. It would be
unfortunate if a last-minute legislative action jeopardized patient safety in unforeseen ways.
In closing, thank you for considering this request to support Senate Bill 3795. It would be a great
honor for you or your appropriate staff member to tour my outpatient vascular access center. If I can
further assist your understanding of interventional nephrology, I would be delighted to do so.
Sincerely,
Your Name
Your Title