Centers for Medicare and Medicaid Joins with FDA in
New Initiative to Improve Patient Safety
Enables CMS to use Medicare Part D claims data for
research, program oversight and evaluation, care coordination, quality
improvement, and performance measurement initiatives
May 22, 2008 - The Centers for Medicare & Medicaid
Services (CMS) will begin sharing data on prescription drug use to help
government agencies and academic researchers improve the safety, quality
and efficiency of health care services, while as part of this new
initiative launched by Health and Human Services, the Food and Drug
Administration will be more proactive in its surveillance of medical
products on the market.
HHS Secretary Mike Leavitt said Thursday that the
programs will complement each other to improve patient safety and the
quality of medical care.
“This initiative will tremendously increase the
FDA’s capacity to monitor the use of medical products on the market,”
Leavitt said.
“We are moving from reactive dependence on
voluntary reporting of safety concerns -- to proactive surveillance of
medical products on the market. In addition, Medicare data on
prescription drug use will be available to help government agencies and
academic researchers improve the safety, quality and efficiency of
health care services.”
In a white paper released by the FDA today, the
agency describes plans for the Sentinel Initiative, which will include
the development of a new electronic system that will enable FDA to query
a broad array of information to identify possible post-market adverse
events.
That Sentinel System will be created through
public-private partnerships and will capitalize on existing large
electronic claims and medical records data sources maintained by private
and government entities that agree to participate in this nationwide
effort.
A CMS final regulation published today will make it
possible for federal agencies, states, and academic researchers to use
claims data from the Medicare prescription drug program (Part D) --
subject to protections for beneficiary privacy and commercially
sensitive data -- for public health and safety research, quality
initiatives, care coordination and other research and analysis.
The Sentinel System is an important example of how
electronic health records and other electronic health information, such
as the Medicare data, can help move the nation toward a system that
delivers safer and better quality health care. President Bush has set
the goal of most Americans having access to an interoperable electronic
health record by 2014.
FDA’s Proposed Sentinel System Will Strengthen
Safety Monitoring of Drugs and Other Medical Products
The new FDA white paper, titled “The Sentinel
Initiative -- A National Strategy for Monitoring Medical Product
Safety,” describes the proposed Sentinel System and calls for a
public-private collaboration to develop and implement it.
Click here to report.
The system would enable FDA to analyze
significantly more information than it can today by tapping into vast
databases of health information to detect early signs of emerging safety
problems.
“With the Sentinel System we will no longer have to
wait years to see how a drug or medical device is affecting millions of
people,” said FDA Commissioner Andrew C. von Eschenbach, M.D.
“The era of ‘wait and see’ is going to become the
era of ‘tell me right now.’ By harnessing the world’s most powerful
information technologies, and by partnering with CMS, the VA and DoD,
and an array of private health care organizations, we will have the
ability to monitor a product’s performance in millions of patients in
real time. The Sentinel System will give us an unprecedented ability to
detect problems as they first begin to surface.”
Creating an active surveillance system such as the
Sentinel System was one of the recommendations made by the Institute of
Medicine in a 2006 report on ways to improve the safe use of drugs. The
recently passed Food and Drug Administration Amendments Act of 2007 (FDAAA)
includes provisions that call for the development of such a system. As
planned, the Sentinel System will fulfill some requirements of FDAAA
while also meeting additional FDA needs.
Access to CMS Data Will Facilitate Public Health
and Safety Research and Quality Initiatives
“We look forward to working with the FDA on the
Sentinel Initiative,” said CMS Acting Administrator Kerry Weems.
“There’s a clear nexus between the data collected through Medicare’s
prescription drug program and the FDA’s role in protecting the public
from adverse events. The public health and safety benefits from this
cooperative venture with the FDA will be substantial.”
Weems noted that CMS’s most recent survey of
beneficiaries indicates that people with Medicare use more than twice as
many medications in a year as do other Americans. Medicare beneficiaries
use an average of 28 prescriptions in a year, while those who consider
themselves in poor health have about 45 prescriptions in a year (source:
Medicare current beneficiary survey, 2004).
In contrast, other Americans use about 13
prescriptions a year, according to a 2007 study by the Agency for
Healthcare Research and Quality (http://www.ahrq.gov/news/nn/nn051607.htm).
Medicare beneficiaries’ high usage of medications, coupled with numerous
chronic health conditions, puts this population segment at higher risk
of adverse drug events than other Americans and makes them the group
most likely to see benefits from the FDA’s new Sentinel Initiative.
The Medicare Prescription Drug Benefit data, linked
to Medicare inpatient and outpatient claims data, will allow the
creation of a highly robust HHS database as the prototype for the
Sentinel System. Publication of the Medicare Part D Claims Data Rule
enables the FDA to use Part D claims data as the FDA explores drug
safety questions related to particular products.
Medicare’s Part D prescription drug program,
implemented in January 2006, has generated claims data on medications
used by the more than 25 million beneficiaries with prescription drug
coverage under the benefit. Linking these data on prescription drug use
to other Medicare claims information, including diagnoses, medical
treatments, hospitalizations, and physician services, will provide the
FDA, other agencies, and researchers with a powerful new tool to
investigate potential drug safety problems and questions about health
outcomes.
With approximately 1 billion claims per year, the
Medicare Part D database is unprecedented in size and scope and will be
a valuable resource for patient safety analyses that will benefit not
only Medicare beneficiaries but the entire nation.
Publication of the final rule today will enable CMS
to use Medicare Part D claims data for research, program oversight and
evaluation, care coordination, quality improvement, and performance
measurement initiatives.
In compliance with beneficiary privacy protections,
as required by the Federal Privacy Act and HIPAA regulations, and while
protecting commercially sensitive data, Medicare drug claims will be
linked to other Medicare information on patient care, such as
hospitalizations and physician visits, and made available to other
federal agencies, state Medicaid programs, researchers, and
beneficiaries for their personal health records.
CMS will be developing guidelines and workshops to
inform researchers on how they can request these data.
