On behalf of the Association of American Medical
Colleges, Darrell G. Kirch, M.D., President,
sent the following comments to CMS Adminstrator
Mark McClellan, M.D., Ph.D., by letter:

The Association of American Medical Colleges <   More...

I appreciate the opportunity to comment on the
proposed changes to Medicare’s guidance document
and National Coverage Decision which provide
coverage and payment for certain costs for
Medicare beneficiaries in routine clinical
   More...

The American Society of Clinical Oncology (ASCO),
the leading medical professional society for
physicians involved in cancer treatment and
research, is pleased to submit comments on
Medicare’s NCA Tracking Sheet for Clinical Trial
P   More...

On behalf of The University of Michigan Health
System (UMHS), we would like to thank the Centers
for Medicare and Medicaid Services for the
opportunity to provide feedback on Medicare’s NCA
Tracking Sheet for Clin   More...

Highmark, Inc.
30-day Public Comment Period: Proposed Clinical
Research Policy

Highmark, Inc. supports the three overarching
goals of the proposed Clinical Research Policy
(herein referred to as pCRP): 1) to allow
Medica   More...

Thank you for the opportunity to comment on the
proposed changes to the national coverage
decision (NCD) governing the Centers for
Medicare and Medicaid Services’ (CMS’) Clinical
Trial Policy (to be renamed    More...

I wish to appeal to CMS to expand their clinical
coverage for clinical trials to include coverage
of routine care for patients who receive a FDA
approved HDE device. By definition, a HDE
device serves less than 4000 patients annua   More...

As it stands now, only pharmaceutical trials are
covered under the NCD, whereas device trials may
be eligible for coverage under device-specific
rules or the NCD. I believe that for continuity,
it would be better if all clinical t   More...

RE: Reconsideration of the National Coverage
Decision on the Clinical Trial Policy
(CAG-00071R)

Dear Dr. McClellan:

On behalf of the American Cancer Society we
welcome the opportunity to submit these comments
relati   More...

The University of Washington, with the largest
federally funded medical research budget of any
public institution in the United States,
appreciates CMS’s reconsideration of its
national coverage decision (NCD) on clinical
trial   More...

Medtronic, Inc. welcomes the opportunity to respond to the Centers for Medicare & Medicaid Services’ (CMS) request for initial public comment on the reconsideration of the National Coverage Determination (NCD) for Routine Care Cos   More...

Many protocols state that the sponsor will pay
for the cost of services in the event that the
patient's insurer does not. CMS has taken the
stand that this statement automatically renders
the sponsor as the primary payer for the <   More...

Dear Administrator McClellan:

The National Venture Capital Association (NVCA)
appreciates this opportunity to comment on the
guidance for national coverage determinations
with data collection as a condition of coverage,
know   More...

UPMC Cancer Centers and the University of
Pittsburgh Cancer Institute (UPCI) appreciate the
opportunity to comment on Medicare’s NCA Tracking
Sheet for Clinical Trial Policy (CAG-00071R) that
was posted July 10, 2   More...

We appreciate the opportunity to comment on the
National Coverage Analysis for Clinical Trial
Policy (CAG-00071R) issued July 10, 2006
regarding changes to the National Coverage
Decision (NCD) for Clinical Trial Policy
establis   More...

One area that I believe needs clarification
pertains to clinical trials that meet qualifiying
criteria to receive Medicare coverage of routine
costs, other than those that are deemed to be
automatically qualified & listed in the NC   More...

I think it is excellent that you are reviewing
this policy but in the process please take into
consideration the impact on Medicare Advantage
plans and develop the necessary actions for them
to take during the implementation of thi   More...

MEDICAL DEVICE MANUFACTURERS ASSOCIATION
Innovation Today For Better Health Care
TomorrowTM

On behalf of the Medical Device Manufacturers
Association (MDMA), a national trade association
representing t   More...

I am writing on behalf of the Advanced Medical
Technology Association (AdvaMed) regarding the
Centers for Medicare and Medicaid (CMS)
reconsideration of its national coverage
decision on the “Clinical Trial Policy   More...

ABIOMED welcomes the opportunity to provide the
following comments on the Centers for Medicare
and Medicaid Services (CMS) decision to
reconsider its national coverage decision (NCD)
on the Clinical Trial Policy.

ABIOMED, I   More...

The National Comprehensive Cancer Network
(NCCN), an alliance of twenty of the world’s
leading cancer centers, is pleased to provide
comments to the Centers for Medicare and
Medicaid Services (CMS) regarding CMS
reconsideration   More...

Genentech, Inc. (“Genentech”) submits these
comments in response to the announcement by the
Centers for Medicare & Medicaid Services (“CMS”)
that it plans to reconsider its national coverage
decision on the Clinical Trial Policy (“   More...

I would first like to acknowledge the importance
of the September 2000 original National Coverage
Decision on Routine Costs in Clinical Trials
regarding federal support in research trials.
Adding clarificatiion to this document is    More...

Novo Nordisk Inc. (Novo Nordisk) appreciates the
opportunity to comment on the Centers for
Medicare and Medicaid Services’ (CMS) Tracking
Sheet regarding the reconsideration of the
current Clinical Trial Policy. As a clinical
t   More...

I am a nurse who coordinates phase one clinical
trials and have had to turn many Medicare
patients away from potentila studies due to their
insurance coverage if the study is deemed by
Medicare. Patients are not able to afford 20%   More...

Boston Scientific Corporation (Boston Scientific)
welcomes the opportunity to comment on the
Centers for Medicare and Medicaid Service’s (CMS)
reconsideration of its national coverage decision
on the Clinical Tria   More...

The Alliance of Dedicated Cancer Centers:
Arthur G. James Cancer Hospital and Richard J.
Solove Research Institute
City of Hope National Medical Center
Dana-Farber Cancer Institute
Fox Chase Cancer Center
H. Lee Moffitt Cancer C   More...

The Society of Gynecologic Oncologists (SGO) is a
national medical specialty society of physicians
who are trained in the comprehensive management
of women with malignancies of the reproductive
tract. Its purpose is to improve the    More...

In support of CMS’ stated goals of facilitating
participation of Medicare beneficiaries in
research studies, the following comments are
submitted with respect to CMS’ review of the
current Clinical Trial Policy.

1. CMS reque   More...

To Whom it may concern:

I want to express my feelings on the following:

Recommendation that FDA approval of an HDE device
automatically provides coverage by CMS for the
limited number of patients

Note HDE by definition   More...

Dear CMS coverage staff:

It is gratifying to note that “CMS is
reconsidering the current Clinical Trial Policy”
to address several issues that have appeared since
its launch in the year 2000. May I submit my
comments, in this co   More...

We are members of the team conducting clinical
trials at Park Nicollet, a Minnesota non-profit
health system that employs over 7800 staff
members, including 489 physicians, and conducts
approximately 300 clinical trials each year.    More...

Re: Reconsideration of Clinical Trial Policy
(CAG-00071R)


Johnson & Johnson (J&J) is the world’s most
comprehensive and broadly based manufacturer of
health care products for the consumer,
pharmaceutical, and medical de   More...

The Biotechnology Industry Organization
(BIO) appreciates this opportunity to comment on
the Centers for Medicare and Medicaid Services’
(CMS) Tracking Sheet regarding the development of
a Clinical Research Policy   More...

On behalf of the Almyra, Inc., a medical device
incubator, I am filing the following comments to
the Centers for Medicare and Medicaid Services’
(CMS) Tracking Sheet regarding the
reconsideration of its national c   More...

The Association of American Cancer Institutes
(AACI), representing 86 of the nation’s premier
academic and freestanding cancer centers,
appreciates this opportunity to comment on
Medicare’s reconsideration of the clinical
trial   More...

This policy has greatly effected the number of
Medicare HMO eligible participants for Qualifying
studies. Many patients cannot afford to have
their Medicare HMO policy convert to Medicare,
requiring them to be responsible for 20% o   More...

The undersigned cancer patient, provider, and
research organizations are writing regarding the
reconsideration of the Medicare coverage policy
on clinical trials. Many of us were involved in
the decade-long legislative    More...

On behalf of the Association of Academic Health
Centers (AAHC), I am pleased to provide comments
on the national coverage decision (NCD) for
clinical trial policy and wish to applaud your
agency for seeking to improve a   More...