February 10, 2015
The Honorable Fred Upton
2183 Rayburn House Office Building
Washington, DC 20515
The Honorable Diana DeGette
2368 Rayburn House Office Building
Washington, DC 20515
Dear Chairman Upton and Congresswoman DeGette,
The American College of Cardiology (ACC) appreciates the opportunity to provide
feedback on the 21st Century Cures discussion draft. The ACC is a 47,000-member
medical society that is the professional home for the entire cardiovascular care team.
The mission of the College is to transform cardiovascular care and improve heart
health. The ACC leads in the formation of health policy, standards and guidelines. The
College operates national registries to measure and improve care, provides professional
medical education, promotes cardiovascular research and bestows credentials on
cardiovascular specialists who meet stringent qualifications. The Journal of the
American College of Cardiology (JACC), which publishes peer-reviewed research on
all aspects of cardiovascular disease, is the most widely read cardiovascular journal
worldwide. JACC is ranked No. 1 among cardiovascular journals worldwide for its
scientific impact.
The College will be providing a two-part response with this letter focusing primarily
on the provisions affecting clinical data registries. We will submit a follow-up response
concerning other issues included in the draft.
The College has extensive experience with clinical data registries and appreciates the
efforts by the Energy and Commerce Committee to bolster federal support for clinical
registries. In 1997 the ACC launched the National Cardiovascular Data Registry®
(NCDR®) as a result of its exploration of various strategies for collecting and utilizing
clinical data to improve cardiovascular care. The outgrowth of that effort focused on
improving patient care through standardized measurements for clinical practice and
patient outcomes. NCDR is committed to including clinicians in its leadership and to
using standardized, clinically relevant data elements and scientifically appropriate
methods to collect, analyze and report outcomes.
Today, more than 2,200 hospitals and over 3,000 clinicians nationwide participate in
the NCDR, resulting in the accumulation of close to 60 million patient records. As the
preeminent cardiovascular data repository in the US, the NCDR provides evidencebased quality improvement solutions to cardiologists and other medical professionals
who are committed to measurement, improvement and excellence in cardiovascular
care. The NCDR, a trusted, patient-centered resource, has also developed clinical
modules, programs and information solutions that support the areas of cardiovascular
care where quality can be measured, benchmarked and improved to make a difference
in patients’ lives. Three of NCDR’s registries include 90 percent or more of the
potential participants identified by procedure type, signifying that these registries are
capturing the vast majority of those specific procedures performed in this country.
NCDR data have been studied for a variety of purposes, including consistency with guidelines,1
appropriateness,2 and comparative effectiveness3, to name a few. The Food and Drug Administration
(FDA) has long been a supporter of NCDR, providing funding for the Improving Pediatric and Adult
Congenital Treatment (IMPACT) Registry and development of an atrial fibrillation registry. NCDR is
also a participant in the FDA’s Sentinel Initiative, looking at methods of utilizing registry data to provide
information on potential safety signals to the FDA. More recently, the College has collaborated with The
Society of Thoracic Surgeons (STS) and the FDA to develop the STS/ACC Transcatheter Valve Therapy
(TVT) Registry™ for use not only as a vehicle for quality improvement, but also to allow for postapproval studies of novel technologies and ongoing postmarket surveillance. Various stakeholders,
including the FDA, the National Heart, Lung and Blood Institute, industry and the public, advise the
College on the appropriateness of ongoing activities within the TVT Registry. Additional efforts are
underway to use other NCDR registries in a similar fashion.
The College also has a strong working relationship with the Centers for Medicare and Medicaid Services
(CMS). The PINNACLE Registry®, ACC’s ambulatory registry, currently contains information on close
to 19 million patient encounters for 4.65 million patients. It has been assisting clinicians with reporting
for Medicare clinical quality measure reporting programs since 2009. It has been serving as a Qualified
Clinical Data Registry (QCDR) since 2014, the first year this program existed. Participating physicians
also use the PINNACLE Registry to fulfill the requirements of the federal Electronic Health Record
(EHR) Incentive Program.
General comments
Definition of clinical data registry
The ACC is pleased to see the Committee’s recognition of the value clinical data registries can provide to
a healthcare learning system. As detailed above, clinical data registries can be used in a myriad of ways.
Because of their versatility, it is important that any legislation set a base definition of clinical data
registries that respects the various purposes they can serve. It also must allow for expansion when
additional requirements are needed to maximize their utility. The College believes that all clinical data
registries should have the following characteristics:
 Valid, needs-based rationale for the registry and the individual data elements collected
 Well-developed organizational structure and support
 Demonstrated commitment to data accuracy and quality
Additional requirements imposed on clinical data registries to address other specific needs should
be developed in consultation with relevant stakeholders, including national medical specialty
societies and clinical data registry operators.
1
Chan PS, Patel MR, Klein LW, et al. Appropriateness of Percutaneous Coronary Intervention. JAMA 2011;
306(1):53-61.
2
Al-Khatib SM, Hellcamp A, Curtis J, et al. Non-evidence-based ICD implantations in the United States. JAMA
2011; 305(1):43-49.
3
Funded by a National Heart, Lung, and Blood Institute American Recovery and Reinvestment Act Grant, the
ASCERT Study represents a unique collaboration between the ACC Foundation and the Society of Thoracic
Surgeons (STS) to study the comparative effectiveness of percutaneous coronary intervention and coronary artery
bypass graft surgery in patients with stable ischemic heart disease.
Needs-based registry development
It is critical that a clinical data registry collect data in a purposeful manner; that is, it should not collect
data simply to collect data. There should be a valid rationale supporting the development of the registry,
and its data elements. Before the ACC commits to the development of a new registry, extensive research
is conducted. Additionally, as the registry is developed, the College works with physicians who have
extensive knowledge of the topic to determine what data elements to collect, as well as how to define
those elements. The ACC recognizes that there is additional work associated with participation in a
clinical data registry and examines the need for each element collected. The draft data collection
definitions and forms are then made available for public comment. Those comments are carefully
reviewed and considered by experts before final decisions on the composition of the registry are made.
The College believes that a high quality clinical data registry must demonstrate this commitment to
development in a purposeful, needs-based manner that addresses important clinical concerns.
Well-developed organizational structure and support
The unintended consequences of participating in a poorly designed registry are numerous. To prevent
this, the College believes it is critical that clinical data registries have a strong organizational
structure governing them. Clinical data registries supporting government programs should be required
to publicly disclose their governance structure, including any board of directors, as well as key
management staff. Conflicts of interest should be disclosed and managed to minimize influence or the
appearance of influence on the clinical data registries themselves, as well as their derivative products.
Leaders of registries should include clinical and healthcare experts with experience in database design,
technical operations and client support. Some registries may be subsidiaries of corporations or not-forprofit organizations. If so, they should be required to disclose their structure in order to participate in
government activities. The process by which clinical data registries make decisions should also be
transparent. Information on NCDR’s governing body, the NCDR Management Board, is available at
www.ncdr.com, as is the governing structure of each registry within the NCDR. NCDR routinely solicits
feedback from the public, clinicians, government officials and others on proposed elements for collection
and their definitions in order to ensure multi-stakeholder participation in the process. Additionally, the
NCDR has created advisory boards to ensure ongoing communication and input from all affected parties.
Clinical data registries should also demonstrate a commitment to patient privacy. Clinical data registries
participating in government programs should be required to demonstrate their compliance with the
privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA), as well as any
other federal privacy laws that are relevant to the government program at issue. The College’s registries
are HIPAA-compliant. Clinical data registries should also be required to contract with an Institutional
Review Board (IRB) to review their work. The College has elected to comply with the Common Rule for
all of its research, federally funded or not, and contracts with a centralized IRB to review registry study
protocols. The College recommends that all clinical data registries participating in federal
programs be required to demonstrate a similar commitment to patient privacy, data security and
IRB review.
Demonstrable commitment to data accuracy and quality
Inaccurate data are as bad as, if not worse than, no data. As such, the College believes that clinical data
registries must demonstrate a commitment to data accuracy by implementing a rigorous data
quality program. There are two components to such a process: ensuring that data are entered properly
and consistently and implementing a process for auditing the data.
To ensure that data are entered properly and consistently, the College supports strong training programs
for program participants on data abstraction, data entry and data extraction. These trainings should also
include education on the definitions of the data elements housed in the registry. The College also supports
the use of clinical data standards where they exist to ensure consistency and integration across registries
and programs. Documentation of a clinical data registry’s adherence to clinical data standards or a reason
as to why it is not following a data standard should be required. High quality clinical data registries
should make their data quality program and training methods transparent.
Additionally, clinical data registries should be required to implement a data audit program. The particular
methodology should vary based on the type of registry. For instance, the audit program ACC has
implemented for its inpatient registries is very different from the one implemented for its ambulatory
registry because the data are entered in different ways. The ambulatory registry relies on data extracted
directly from the EHR, so the audit program focuses on ensuring that the algorithms for data extraction
are working correctly and that the data fields are properly mapped. The inpatient registries rely on data
manually entered by data abstracters, so the audit program focuses on reviewing the original records to
ensure that the abstracters entered the data into the registry correctly. As such, the College believes that
clinical data registries should be required to implement strong data audit programs but
recommends that there be flexibility in the specific methodologies applied based on the manner in
which data are gathered and entered into the registry.
Access to Death Master File
To add further value to clinical data registries, it is critical that they can be cross-linked to external data
sources, such as CMS claims data, the Death Master File (DMF) maintained by the Social Security
Administration and the Center for Disease Control’s National Death Index. The DMF is a unique data
source because it contains vital status information on the US population, independent of payer status.
DMF data are updated on a more frequent basis than any other data sources and in a more timely fashion,
and are thus able to provide more meaningful feedback on patient outcomes. For instance, these data
would be useful in the development and ascertainment of outcomes and readmission measures, as well as
for answering related research questions. These activities require access to name, social security number,
date of birth and date of death for deceased individuals. However, laws that limit access to the DMF to
legitimate users have made it difficult for organizations like the ACC to obtain such data. As stated
above, clinical data registries are required to comply with HIPAA and other relevant data privacy and
security laws and regulations, thereby reducing concerns regarding inappropriate access to personal
information. As such, the College urges Congress to once again make the DMF available to clinical
data registries that have demonstrated these commitments to privacy and security.
Discoverability of clinical data registry data
Given that most clinical data registries are primarily focused on improving the quality of patient care, the
College urges the Committee to remove concerns that participants may have regarding legal discovery of
data housed in registries via subpoenas or other maneuvers. In order to develop best practices, it is
important to analyze and understand not only instances in which problems occurred, but also those in
which no problems occurred. To that end, the ACC recommends that the Committee add a provision
to the legislation that would protect data held by clinical data registries from legal discovery.
Patient matching
To improve the quality of care, patients should be able to be tracked across settings and institutions. This
cannot be done without the ability to match patients with their data. This means that data entered into
EHRs and other databases must be clean and accurate. Even the entry of one wrong number can affect
and prevent the matching of patient data. In the context of a nationwide health information network that
facilitates the sharing of patient data, this could prevent a physician from learning about a serious health
condition suffered by a patient because certain identifying information did not match. It also complicates
conducting longitudinal research across datasets because of the difficulties in matching patients.
Improving patient matching methodologies will allow for linkages of healthcare databases with relevant
government databases, including those with information regarding economic and social characteristics.
These linkages will improve the quality of research and lead to better patient care informed by enhanced
longitudinal tracking. The ACC urges the Committee to support the development of methodologies
for patient matching across datasets and for high quality data capture.
Specific comments
The College’s comments below are provided in the same section-by-section manner as laid out in the
discussion draft for ease of review.
Title II, Subtitle F, Part 2 – Improving Clinical Outcomes for Patients and Program Integrity
Through CMS Data
Sec. 2085 Expanding Availability of Medicare Data
(b) Access to Medicare Data by Qualified Clinical Data Registries to Facilitate Quality Improvement
(1) Access
The College is concerned by the clear attempt to restrict access to Medicare data to only “qualified
clinical data registries” (QCDRs), which CMS has defined through regulation only for the purposes of the
Physician Quality Reporting System Program.4 The statute defines a QCDR as, among its other
characteristics, “provid[ing] timely performance reports to participants at the individual participant
level...” CMS has defined this as a requirement to report on the individual participant level; however,
“participant” in this instance refers to the physician and non-physician professionals eligible to participate
in the Physician Quality Reporting System (PQRS).
Not all registries focus on quality improvement at the clinician level. For instance, ACC has two different
models for registry participation. As described earlier, the outpatient registry, PINNACLE, is a QCDR.
PINNACLE contracts with individual physicians, non-physician practitioners, therapists, or physician
practices and reports at the individual professional level. NCDR’s inpatient registries contract and report
at the hospital level. As such, these hospital registries that meet all of the technical requirements of this
section would presumably be unable to qualify to receive access to Medicare data only because they are
not used for quality reporting under the Medicare Physician Fee Schedule. The goal is the same in both
instances – improvement in patient care, but the method for achieving that goal is different. The College
urges the Committee to explicitly state that clinical data registries, including those that collect data
at the hospital level, are able to obtain access to this Medicare data.
This same provision requires that the data be used only to “[perform] risk-adjusted, scientifically valid
analysis and research to support quality improvement or patient safety.” While the ACC certainly
supports use of the data for these purposes, limiting it only to “risk-adjusted” analysis will limit the
usefulness of this provision. The College is examining ways to develop cost measures and longitudinal
outcome measures using data from our registries. While ultimately the goal would be to risk adjust these
measures, this will likely not be feasible for new measures in the short run, thereby limiting the College’s
ability to perform this type of work under the current language. It also limits the College’s ability to use
registry data for scientific discovery, as this research may not always be risk-adjusted. Limiting the types
4
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory
FeeSchedule & Other Revisions to Part B for CY 2014, 78 Fed. Reg. 44465 (Dec 10, 2013).
of analyses that can be performed with Medicare data will require that clinical data registries engaged in
quality improvement or patient safety activities that are not risk-adjusted apply for Qualified Entity status
for the same data they can access for other activities. This creates an additional burden to using the data,
and thus, increases the cost and timeline for performing such research and analyses. To allow clinical
data registries to support scientific research, quality improvement and patient safety, the ACC
recommends that the Committee remove the limitation on the use of Medicare data for only riskadjusted analysis.
The College strongly supports the right of physicians and hospitals to appeal and correct errors in any
publicly reported data regarding their performance. However, the College urges the Committee to
clarify that clinical data registries are not required to accept appeals and corrections of errors in
the underlying Medicare data obtained under this provision. Clinical data registries should only bear
the burden of correcting errors made in data they collected and obtained from participants. Errors in the
underlying Medicare data must be addressed by registry participants with Medicare directly. Only where
the registry participant can demonstrate that Medicare has acknowledged an error should registries be
required to include that as part of the appeals process.
(2) Fee
Language in the discussion draft would limit the fee charged to a QCDR for data access to the cost of
providing such data. The College has existing contracts with CMS that allow ACC limited access to
certain Medicare data sets and the College provides CMS access to certain NCDR data sets. The ACC
urges the Committee to make clear that such exchanges of data remain acceptable.
Title II, Subtitle F, Part 3 – Compliance by Clinical Data Registries with HIPAA Privacy and
Security Law
Sec. 2091 Commission on Data Sharing for Research and Development
Sec. 2092 Recommendations for Development and Use of Clinical Data Registries
The College appreciates the Committee’s clear support for development and integration of clinical data
registries and observational data into the healthcare learning environment. That said, Secs. 2091 and 2092
appear to be duplicative in purpose: the development and publication of best practices for registries.
Rather than creating two bodies to develop recommendations for the same purpose, the ACC
recommends that the Committee eliminate one of these sections.
Whether the Committee chooses to have a commission or the Secretary develop these recommendations,
the College urges the Committee to require inclusion of and/or consultation with clinical data registry
experts, and in particular with leaders of national medical specialty society-led clinical data registries.
The selected group should ensure that they consider all potential uses of clinical data registries, including
performance measurement, quality improvement, postmarket surveillance and more. As discussed
earlier, all clinical data registries need not be able to perform all of these functions. Instead, the
requirements imposed on clinical data registries should vary based on the task being performed, outside
of the core requirements outlined above. Before implementing any recommendations pertaining to
clinical data registries, the College urges the Committee to require consultation with key
stakeholders such as national medical specialty societies and to provide public notice and comment
for any of those recommendations that can be implemented without Congressional action, as well
as full public discussion of any recommendations requiring Congressional authorization.
Title II, Subtitle G – Utilizing Real-World Evidence
Sec. 2101 Utilizing Real-World Evidence
The College strongly supports the use of real-world evidence to support approvals of new
indications for drugs, as well as to meet or support post-approval study requirements. Clinical data
registries capture real-world evidence on drugs and devices. This evidence may include observations
made when the drug or device was used in a manner not consistent with an FDA-approved indication.
This information may provide sufficient cause to expand or restrict the uses of the drug or device.
Title II, Subtitle M – Accessing, Sharing, and Using Health Data for Research Purposes
Sec. 2221 Accessing, Sharing, and Using Health Data for Research Purposes
The College supports the proposed amendment to Sec. 13441 of the HITECH Act to include
research in the definition of healthcare operations under HIPAA when the disclosure being made
for research purposes is made to another covered entity for healthcare operations, to a business
associate whose function is to perform healthcare operations for the disclosing covered entity or to
a business associate whose function is to perform data aggregation. This change will enable
researchers to make more effective use of the data housed in clinical registries focused on quality
improvement by allowing them to use such data for the development of generalizable knowledge in a less
burdensome and cost-effective manner, with benefit to the entire healthcare learning system.
The proposed new Sec. 13442 of the HITECH Act is similarly helpful in that it will better enable clinical
data registries to assist in the reporting of potential signals or adverse events to manufacturers of drugs or
devices, particularly where the data registry is performing a post approval study or is participating in the
Sentinel Program or National Medical Device Postmarket Surveillance System. The College supports
the inclusion of this provision in the legislation.
New Sec. 13443 recognizes the change in technology since the issuance of the HIPAA regulations and
permits remote access by researchers to protected health information (PHI), assuming appropriate
security and privacy safeguards remain in place and the researcher does not retain copies of the PHI. The
College is supportive of this provision as well.
The College is a strong supporter of patient-centered care, and as such, supports the ability of patients to
consent to their data being used for research purposes. That said, it is difficult for clinical data registry
operators that have no direct interactions with patients and are conducting retrospective analyses of data
to obtain consent for the use of the data each time the data are used. As such, the ACC strongly
supports the addition of new Sec. 13444 to the HITECH Act, providing covered entities with the
ability to obtain one-time valid authorizations for the use or disclosure of individuals’ PHI with
respect to all future research purposes and urges the Committee to include this provision in the
legislation when it is introduced. Additionally, as strong supporters of patients’ rights, the College also
supports the ability of patients to withdraw that authorization. The legislation must explicitly state that
the burden is on the entity receiving notice of the withdrawal to communicate that information to the
entity that originally obtained the consent (if not the same as the entity receiving the withdrawal notice).
Additionally, the College urges the Committee to clarify that the burden of notifying all entities
that had been granted access to the data that they may no longer use the data for future research
falls on the entity that originally obtained consent from the patient. Additionally, the College urges
the Committee to clarify that the withdrawal of consent does not apply where the data are already
included in ongoing research.
It is important to recognize that the FDA has additional regulations pertaining to privacy and patient
consent. The College urges the Committee to include a requirement that the FDA allow for the use
of an authorization similar to that described in the new Sec. 13444. This would further enable use of
the data for postmarket surveillance of drugs and devices, as well as for any additional post approval
studies.
The ACC has some significant concerns regarding the proposed new Sec. 13445. Currently, entities such
as ACC enter into Data Use Agreements (DUAs) with participants, as well as individuals or entities that
perform work on behalf of the College. These agreements provide the ACC with legal methods for
holding participants and subcontractors accountable for their actions. These DUAs are included in the
packet of materials reviewed by the College’s IRB, along with research protocols, information pertaining
to the ACC’s data security policies and other documentation. New Sec. 13445 would weaken the ability
of the College and other entities in similar situations to hold participants or subcontractors responsible for
certain legal requirements. In particular, the College’s DUAs specifically require that ACC’s contractors
and subcontractors notify the organization of wrongful disclosures. Additionally, the DUAs include
requirements pertaining to subcontractors of entities with whom the College directly contracts. The
proposed provision does not address either of these situations. The ACC strongly urges the Committee
not to include this new Sec. 13445 in the legislation when it is introduced.
Title III, Subtitle A – Clinical Research Modernization
Sec. 3001 Protection of Human Subjects in Research; Applicability of Rules
Currently, federal agencies are not required to follow the HHS Human Subject Regulations. Instead, they
are given the option of either voluntarily signing onto these regulations or creating their own. Providing
them with this option creates confusion and is unnecessarily burdensome for researchers attempting to
navigate the maze of patient and human subject protections. For instance, the FDA has opted not to sign
onto the Common Rule, preferring to issue its own regulations. The Common Rule permits the granting
of waivers in certain circumstances that the FDA regulations do not, and no clear justification for this
difference is provided. HIPAA also provides for waivers or exceptions in certain circumstances that may
not be permitted under either the Common Rule or the FDA regulations, again without clear justification
for the distinction. In fact, the College has participated in multiple meetings with officials from across the
Department of Health and Human Services who fail to grasp the confusion they have created, as well as
the burdens they have imposed, in their well-meaning attempts to protect patients and human subjects. As
such, the College urges the Committee to require HHS to develop a comprehensive set of unified
regulations and guidance documents, including justification when there is a continued discrepancy
between agency requirements.
As the operator of NCDR, the College takes great pride in its efforts to protect the rights of human
subjects and has voluntarily opted to comply with the requirements of the Common Rule and the rules
pertaining to vulnerable populations. The College has contracted with a centralized IRB to ensure its
compliance with these rules, as described above. Many NCDR participants contract with local IRBs that
require additional review of the participants’ involvement in NCDR activities. To that end, the College
faces the added burden and expense of assisting these participants in responding to their own IRBs; the
participants bear the costs of the additional IRB review. The proposed legislation, much like recent
proposed guidance issued by the National Institutes of Health, would send a clear signal to local IRBs
that approval of multisite research by centralized or “lead” IRBs is sufficient, thereby reducing the costs
and burdens on clinical data registry operators, participants and the system as a whole. The College
strongly supports this proposal and urges the Committee to include it in legislation.
Sec. 3002 Use of Institutional Review Boards for Review of Investigational Device Exemptions
This proposed provision further clarifies the Committee’s support for the contention that multisite
research does not require review by multiple IRBs. As discussed above, the ACC strongly supports
this clarification.
Title V, Subtitle D – Medical Device Reforms
Sec. 5062 Valid Scientific Evidence
Sec. 5062 is similar to Sec. 2101, except for its application to medical devices as opposed to drugs. As
such, the College enthusiastically supports the inclusion of this provision in legislation, particularly after
having encountered difficulties with exactly this situation. The STS/ACC TVT Registry collects
information on all patients who receive transcatheter aortic valves, regardless of the specified indication
for use. Using data from the registry, the FDA was able to expand the label indication for the device to a
new patient population without requiring the time and expense of a new trial. However, the process for so
doing was complicated by concerns regarding investigational device exemption (IDE) regulations and
standard FDA processes and protocols. Rather than requiring manufacturers and operators of
clinical data registries to negotiate the complicated IDE regulations, the FDA should be allowed to
use observational data to expand indications for use of a device, particularly in situations where the
device’s safety profile has already been established. To that end, the College urges the Committee
to include such a provision upon introduction of the legislation. Additionally, the ACC
recommends that the legislation clarify that a party interested in using retrospective data from a
registry for the purposes of label expansion need not apply for an IDE.
Removing barriers to innovation and bringing new therapies to the healthcare space are worthy goals. We
applaud the Committee for this important effort. The College looks forward to working with you and
your staff as the process moves forward. Nick Morse, ACC’s Director of Congressional Affairs, will
follow up to offer further assistance.
Sincerely,
Patrick T. O’Gara, MD, FACC
President