Steven A. Wartman, MD, PhD, MACP February 5, 2008 President/CEO …

Steven A. Wartman, MD, PhD, MACP     February 5, 2008
President/CEO

Board of Directors
                                     Kerry Weems, MBA
Arthur Rubenstein, MBBCh             Acting Administrator
Executive Vice President for
the Health System                    Centers for Medicare and Medicaid Services
Dean, School of Medicine             200 Independence Avenue, SW
University of Pennsylvania
Chair                                Mail Stop 314G
Nancy W. Dickey, MD
                                     Washington, DC 20201
President, Texas A&M
Health Science Center
Vice Chancellor for Health Affairs   Dear Mr. Weems:
Texas A&M University System
Chair-Elect
                                     I am writing on behalf of the members of the Forum on Regulation of the
Michael V. Drake, MD                 Association of Academic Health Centers (AAHC) to express our strong
Chancellor
University of California, Irvine     concern about the new Healthcare Common Procedure Coding System
Immediate Past Chair
                                     (HCPCS) modifiers for billing patient care in clinical research studies.
Barbara Atkinson, MD                 Specifically, the timing of the deletion of the former QA, QR and QV modifiers
Executive Vice Chancellor
and Executive Dean,                  and announcement of their replacements, and the resulting suspension of
School of Medicine
University of Kansas
                                     claims processing until billing systems can be reprogrammed to implement
Medical Center                       the new Q0 and Q1 modifiers, has imposed a substantial and unacceptable
John Fernandes, DO, MBA              financial burden on academic health centers conducting clinical research
President                            studies without meeting the Centers for Medicare & Medicaid Services' (CMS)
Oklahoma State University
Center for Health Sciences           stated purpose of eliminating confusion and uncertainty regarding how the
                                     modifiers should be applied. The purpose of this letter is to communicate the
Antonio M. Gotto, Jr., MD, DPhil
Stephen and Suzanne Weiss Dean       AAHC's specific concerns, including concern for the ongoing viability of the
and Provost, Medical Affairs
Weill Medical College and Graduate
                                     clinical trial enterprise, as well as the AAHC's recommendations, including a
School of Medical Sciences           collaborative mechanism for minimizing avoidable disruption.
Cornell University

Jane E. Henney, MD                   Background - The 2007 Annual HCPCS Update contains three modifiers to
Senior Vice President and
Provost for Health Affairs           bill for patient care when beneficiaries are enrolled in clinical research
University of Cincinnati             studies:
Philip A. Pizzo, MD                       · QA - FDA Investigational Device Exemption;
Dean, School of Medicine
Stanford University
                                          · QR - Item or Service Provided in a Medicare Specified Study; and
Sheldon M. Retchin, MD, MSPH
                                          · QV - Item or Service Provided as Routine Care in a Medicare
Chief Executive Officer, VCU                  Qualifying Clinical Trial.
Health System, Vice President
for Health Sciences
Virginia Commonwealth University     In response to its expressed concern that these modifiers were not being
Larry J. Shapiro, MD                 used as intended, CMS announced on January 18, 2008 a revision of its
President, Washington University     modifier coding policy discontinuing the QA, QR, and QV modifiers as of
Medical Center, Executive Vice
Chancellor for Medical Affairs and   December 31, 2007, and creating two new modifiers that will be used solely
Dean, School of Medicine             to differentiate between routine and investigational clinical services:
Washington University
                                         · Q0 - Investigational clinical service provided in a clinical research
Andrew A. Sorensen, PhD                      study that is in an approved clinical research study. Investigational
President
University of South Carolina                 clinical services are defined as those items and services that are being
                                             investigated as an objective within the study. Investigational clinical

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Kerry Weems, MBA
February 5, 2008
Page 2

       services may include items or services that are approved, unapproved, or otherwise
       covered (or not covered) under Medicare.
   ·   Q1 - Routine clinical service provided in a clinical research study that is in an
       approved clinical research study. Routine clinical services are defined as those items
       and services that are covered for Medicare beneficiaries outside of the clinical
       research study; are used for the direct patient management within the study; and,
       do not meet the definition of investigational clinical services. Routine clinical services
       may include items or services required solely for the provision of the investigational
       clinical services (e.g., administration of a chemotherapeutic agent); clinically
       appropriate monitoring, whether or not required by the investigational clinical service
       (e.g., blood tests to measure tumor markers); and items or services required for the
       prevention, diagnosis, or treatment of research related adverse events (e.g., blood
       levels of various parameters to measure kidney function).

These new modifiers will be included in the 2008 Annual HCPCS Update and are effective for
dates of service on and after January 1, 2008. All claims submitted for patient care in
clinical research studies must use the two new modifiers for routine and investigational
clinical services. This includes studies that are certified under the Medicare Clinical
Research Policy, Investigational Device Exemption (IDE) trials, and studies required under a
coverage with evidence development (CED) national coverage determination (NCD).
Effective for dates of service on and after January 1, 2008, claims submitted with the
discontinued modifiers will be processed as return-to-provider/return as unprocessable.

AAHC Concerns ­ The AAHC has several specific concerns about the timing and process of
the deletion of the former modifiers and release of the replacement modifiers.
   · The timing of the change is very disruptive for academic health centers and their
       claims processing partners, and will result in an unreasonable and unjustifiable
       suspension of billing for patient care in clinical research studies. The deleted
       modifiers are only valid through December 31, 2007, yet the replacement modifiers
       were not released until 18 days after that date and are not required to be
       implemented by carriers, FIs and MACs until April 7, 2008. This means academic
       health centers and their claims processing partners have no transition period in
       which to modify data systems and retrain staff to implement the new modifiers prior
       to the expiration of the prior modifiers. Since it will take at minimum several weeks
       -- and in the case of some carriers, FIs and MACs, several months -- to make the
       necessary changes, CMS's policy change will result in a de facto suspension of billing
       for patient care in clinical research studies until the implementing systems changes
       can be made. The AAHC believes this avoidable disruption is unreasonable and
       unjustifiable because the change appears to have been made with little or no
       consultation with affected entities regarding the predictable consequences of the
       timing and manner in which the change was made.
   · A policy change designed to result in a suspension of billing for patient care in clinical
       research studies for as much as three months shows apparent disregard for the
       financial burden such suspension of billing imposes on academic health centers and
       other institutions conducting clinical research studies. The disruption to cash flow
       resulting from an up-to-three-month suspension of billing will have a significant
       impact on the financial integrity of many institutions conducting clinical research
       studies. Rather than create incentives for the inclusion of Medicare beneficiaries in
Kerry Weems, MBA
February 5, 2008
Page 3

       clinical research studies, such disruption creates barriers to their continued
       participation. Moreover, it does nothing to create efficiencies in U.S. institutions and
       thus slow the increasing trend toward moving clinical research studies overseas.
       This disruption could have been avoided entirely had CMS issued the policy change in
       a timely manner. Its failure to do so is further compounded by its failure to offer any
       compelling rationale for the poor timing of the policy change, showing apparent
       disregard for the financial burden imposed.
   ·   Despite CMS' stated desire to address inconsistency in the manner in which the prior
       modifiers were used, the timing and process for releasing the new modifiers has
       resulted in significant confusion within the affected community. Without advanced
       notice or dialogue with the affected community, CMS now requires billing for clinical
       research studies to distinguish on the claim what is investigational and what is
       routine care. Contrary to CMS' assertion, the new modifiers are not significantly
       simpler or more understandable than the prior modifiers, and do not appear to
       function as one-to-one replacements for the prior modifiers (especially considering
       divergent past practices). For example, based on initial readings of the manual, it
       appears that both Q0 and Q1 must be used on Part B claims at a line item/CPT level
       to distinguish the investigational-related items and the routine services provided
       within an approved clinical research study. Affected institutions are also scrambling
       to identify the Part A impact and the time line within which necessary system
       changes will be completed. The lack of timely notice and pre-release dialogue
       seriously undermined the ability of academic health centers to understand the full
       implications of the new policy and meet their audit compliance requirements.
   ·   Inadequate and inconsistent communications from carriers, FIs and MACs to
       academic health centers is compounding the problems caused by the poor timing of
       the policy change. Based on our conversations to date with academic health center
       representatives, there is significant variation in the level of awareness and
       understanding of the policy change within affected entities. CMS' monitoring and
       oversight of communications from carriers, FIs and MACs to academic health centers
       and other affected entities about the policy change does not appear to be sufficient
       to ensure that needed information about the policy change is being conveyed in a
       timely manner.

AAHC Recommendations ­ In consideration of the concerns discussed above, the AAHC
urges CMS to consider the following recommendations:
   · The AAHC believes the poor timing of the policy changes to the HCPCS modifiers for
       billing patient care in clinical research studies is unreasonable and unjustified. The
       only effective remedy for the resulting unacceptable interruption of billing is the
       immediate reinstatement of the QA, QR and QV modifiers for continued use until
       April 7, 2008 when the Q0 and Q1 modifiers are required to be in effect. Therefore,
       AAHC urges CMS to immediately reinstate the use of the deleted modifiers to provide
       an adequate transition period until the new modifiers are implemented in April.
   · The AAHC recognizes CMS' need to make periodic policy changes; however, CMS also
       has an obligation to make those policy changes in the least disruptive manner
       possible. The AAHC requests that CMS meet with AAHC members on a regularly
       scheduled basis, by telephone or in person as most appropriate, to discuss the
       potential impact of possible changes to billing operations and procedures. Through
       regular dialogue AAHC can assist CMS achieve its objectives while minimizing the
Kerry Weems, MBA
February 5, 2008
Page 4

recurrence of avoidable confusion and financial hardship and their adverse impact on the
clinical trial enterprise.

The AAHC looks forward to working with CMS to facilitate scheduling such meetings and
developing agendas for discussion. Mr. Anthony Knettel and Dr. Elaine Rubin are
coordinating AAHC activities related to this issue; they can be reached at 202-265-9600 or
by email at aknettel@aahcdc.org and erubin@aahcdc.org respectively.

Sincerely,




Steven A. Wartman, MD, PhD, MACP
President/CEO


CC: Steve Phurrough
Leslye K. Fitterman