Medicare Program; Announcement of Request for Applications for the Million Hearts® Cardiovascular Risk Reduction Model, 31040-31041 [2015-13042]
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31040
Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–5513–N]
Medicare Program; Announcement of
Request for Applications for the Million
Hearts® Cardiovascular Risk
Reduction Model
Centers for Medicare &
Medicaid Services (CMS), HHS
ACTION: Notice.
AGENCY:
This notice informs interested
parties of an opportunity to apply for
participation in the Million Hearts®
Cardiovascular Risk Reduction Model.
The primary goal of this model is to test
whether encouraging physician
practices to calculate risk for all of the
practice’s eligible Medicare
beneficiaries, using the American
College of Cardiology/American Heart
Association (ACC/AHA) Atherosclerotic
Cardiovascular Disease (ASCVD) 10year pooled cohort risk calculator will
prevent the occurrence of first-time
heart attacks and strokes.
DATES: Applications will be considered
timely if they are received on or before
September 4, 2015 as outlined in the
Request for Applications (RFA).
SUMMARY:
Note: Interested applicants will be required
to submit a non-binding Letter of Intent (LOI)
to apply for the model.
All LOIs must be submitted
electronically through the Center for
Medicare and Medicaid Innovation Web
site at: https://innovation.cms.gov/
initiatives/Million-Hearts-CVDRRM/.
LOIs will be accepted throughout the
entire application period, ending
September 4, 2015. Applicants will
need to use their LOI confirmation
number to access the RFA. All
applicants will receive a RFA
submission confirmation number; it is
the applicant’s responsibility to retain a
copy of the confirmation number for
proof of submission.
FOR FURTHER INFORMATION CONTACT:
Nina Brown at (410) 786–6103 or email
address: mhmodel@cms.hhs.gov. The
Center for Medicare and Medicaid
Innovation Web site is at https://
innovation.cms.gov/.
SUPPLEMENTARY INFORMATION:
Lhorne on DSK2VPTVN1PROD with NOTICES
ADDRESSES:
I. Background
The Center for Medicare and
Medicaid Innovation (Innovation
Center), within the Centers for Medicare
& Medicaid Services (CMS), was created
to test innovative payment and service
delivery models to reduce program
VerDate Sep<11>2014
14:50 May 29, 2015
Jkt 235001
expenditures while preserving or
enhancing the quality of care for
Medicare, Medicaid, and Children’s
Health Insurance Program beneficiaries.
We are interested in models designed
to improve care for specific populations.
One population is Medicare fee-for
service (FFS) beneficiaries 18 to 79
years of age who have never had a heart
attack or stroke and who are not under
hospice care. Current evidence suggests
that preventive cardiovascular disease
interventions can significantly reduce
both adverse cardiovascular-related
outcomes and death. The Million
Hearts® Cardiovascular Risk Reduction
Model (hereinafter referred to as ‘‘CVD
Risk Reduction Model’’) seeks to test
whether providing incentives for
physician practices to calculate absolute
10-year cardiovascular risk reduction,
measured by the American College of
Cardiology/American Heart Association
(ACC/AHA) 10-year pooled cohort risk
calculator, is effective in reducing heart
attacks and strokes among Medicare FFS
beneficiaries. Intervention group
practices will engage in shared decision
making, team-based care, and
population health management to
reduce beneficiaries’ absolute risk.
Intervention group practices will be
required to submit quality data to CMS
supported by a per-beneficiary-permonth payment.
The Innovation Center is operating
this model under the authority of
section 1115A of the Social Security Act
(the act) (42 U.S.C. 1315a) (as added by
section 3021 of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148), as amended by the Health Care
and Education Reconciliation Act of
2010 (Pub. L. 111–152), (collectively
known as Affordable Care Act)). We will
evaluate whether this model reduces the
occurrence of heart attacks and strokes
as well as Medicare expenditures and
enhances the quality of care furnished
to Medicare beneficiaries.
II. Provisions of the Notice
The RFA is directed to physician
practices that include private practices,
hospital-owned physician practices,
large medical networks, hospital/
physician organization, or independent
practice associations. Up to 720
practices are expected to participate.
Participating practices must meet the
following requirements:
• Practices must have at least one
practitioner. Practitioners are defined as
Medical Doctors, Doctors of Osteopathic
Medicine, Physician Assistants, and
Nurse Practitioners.
• Practices must be using an Office of
the National Coordinator for Health
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Information Technology (ONC) certified
electronic health record (EHR) system.
• Participating physicians or other
eligible professionals within the
practice must have met the criteria for
the Medicare EHR Incentive Programs in
performance year 2015, also known as
‘‘meaningful use,’’ of an ONC certified
electronic health record.
Practices selected to participate will
be randomized to the intervention group
or the control group. Practices
randomized to the control group will be
required to submit data to CMS at the
beginning of the first, second, third and
fifth years of the model. Control group
practices will receive a one-time
payment of $20 per-beneficiary
following the successful transmission of
data to CMS on eligible beneficiaries
within their practices. Practices
randomized to the control group will
receive no further funding beyond this
one-time payment.
Practices randomized to the
intervention group will be paid a onetime upfront payment of $10 perbeneficiary to conduct initial risk
stratification for eligible beneficiaries in
addition to a $10 per-beneficiary-permonth fee for ongoing monitoring of
high-risk FFS Medicare beneficiaries.
Starting in the second year of the model,
the $10 per-beneficiary-per-month
ongoing fee is gradually placed at risk
based on a practice’s performance
managing its ‘‘high-risk’’ beneficiaries.
Intervention group practices in the
CVD Risk Reduction Model will use the
ACC/AHA Atherosclerotic
Cardiovascular Disease (ASCVD) 10year pooled cohort risk calculator to risk
stratify Medicare FFS beneficiaries 18 to
79 years of age meeting the inclusion
criteria. Practices will further identify
whether beneficiaries are ‘‘high-risk’’
defined by their 10-year ASCVD risk
score: A ‘‘high risk,’’ beneficiary is
defined as a beneficiary with an ACC/
AHA 10-year ASCVD risk score greater
than or equal to 30 percent. Once the
high risk beneficiaries have been
identified, intervention group practices
will engage in risk modification and
report process and outcome measures of
their results. Practices will be required
to submit annual data to CMS through
a certified Data Registry, which will be
provided to participating practices by
CMS.
The CVD Risk Reduction Model
period of performance is 5 years.
Selected practices will enter into Model
Participant Agreements with CMS.
Applicants must present evidence that
the applicant practices are capable of
successfully identifying beneficiaries
who meet the CVD Risk Reduction
Model eligibility requirements.
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Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices
Applicants must also demonstrate their
plans for engaging in shared decision
making activities with their
beneficiaries. Applicants are required to
submit to CMS general beneficiary data,
the clinical indicators needed to
calculate the 10-year ASCVD risk score,
and the cardiovascular Physician
Quality Reporting System (PQRS)
measures as outlined in the RFA.
Eligible practices will be selected on a
first come, first served basis until all 720
spots have been filled. Applications
must be submitted timely in the
standard format outlined in the CVD
Risk Reduction Model RFA in order to
be considered for review. Applications
that are not received in this format will
not be considered for review.
For more specific details regarding the
CVD Risk Reduction Model (including
the RFA), we refer applicants to the
informational materials on the
Innovation Center Web site at: https://
innovation.cms.gov/initiatives/MillionHearts-CVDRRM/. Applicants are
responsible for monitoring the Web site
to obtain the most current information
available.
III. Collection of Information
Requirements
Section 1115A(d)(3) of the Social
Security Act states that chapter 35 of
title 44, United States Code (the
Paperwork Reduction Act of 1995), shall
not apply to the testing and evaluation
of models or expansion of the models
under this section. Consequently, there
is no need for this document to be
reviewed by the Office of Management
and Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
Dated: May 15, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–13042 Filed 5–28–15; 11:15 am]
Lhorne on DSK2VPTVN1PROD with NOTICES
BILLING CODE 4120–01–P
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14:50 May 29, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–1804]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Studies
To Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
General Approach To Establish an
Acute Reference Dose; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry (GFI) #232
entitled ‘‘Studies to Evaluate the Safety
of Residues of Veterinary Drugs in
Human Food: General Approach to
Establish an Acute Reference Dose
(ARfD)’’ (VICH GL54). This draft
guidance has been developed for
veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This draft VICH guidance
document is intended to address the
nature and types of data that can be
useful in determining an ARfD for
residues of veterinary drugs, the studies
that may generate such data, and how
the ARfD may be calculated based on
these data.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 31, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Policy and Regulations Staff (HFV–6),
Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
SUMMARY:
PO 00000
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31041
FOR FURTHER INFORMATION CONTACT:
Tong Zhou, Center for Veterinary
Medicine (HFV–153), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0826,
Tong.Zhou@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry #232
entitled ‘‘Studies to Evaluate the Safety
of Residues of Veterinary Drugs in
Human Food: General Approach to
Establish an Acute Reference Dose
(ARfD)’’ (VICH GL54). In recent years,
many important initiatives have been
undertaken by regulatory authorities
and industry associations to promote
the international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based
harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify, and then
reduce, differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH)
for several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission;
European Medicines Evaluation Agency;
European Federation of Animal Health;
Committee on Veterinary Medicinal
Products; FDA; the U.S. Department of
Agriculture; the Animal Health
Institute; the Japanese Veterinary
Pharmaceutical Association; the
Japanese Association of Veterinary
Biologics; and the Japanese Ministry of
Agriculture, Forestry, and Fisheries.
Six observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
E:\FR\FM\01JNN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31040-31041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13042]
[[Page 31040]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-5513-N]
Medicare Program; Announcement of Request for Applications for
the Million Hearts[supreg] Cardiovascular Risk Reduction Model
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice informs interested parties of an opportunity to
apply for participation in the Million Hearts[supreg] Cardiovascular
Risk Reduction Model. The primary goal of this model is to test whether
encouraging physician practices to calculate risk for all of the
practice's eligible Medicare beneficiaries, using the American College
of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic
Cardiovascular Disease (ASCVD) 10-year pooled cohort risk calculator
will prevent the occurrence of first-time heart attacks and strokes.
DATES: Applications will be considered timely if they are received on
or before September 4, 2015 as outlined in the Request for Applications
(RFA).
Note: Interested applicants will be required to submit a non-
binding Letter of Intent (LOI) to apply for the model.
ADDRESSES: All LOIs must be submitted electronically through the Center
for Medicare and Medicaid Innovation Web site at: https://innovation.cms.gov/initiatives/Million-Hearts-CVDRRM/. LOIs will be
accepted throughout the entire application period, ending September 4,
2015. Applicants will need to use their LOI confirmation number to
access the RFA. All applicants will receive a RFA submission
confirmation number; it is the applicant's responsibility to retain a
copy of the confirmation number for proof of submission.
FOR FURTHER INFORMATION CONTACT: Nina Brown at (410) 786-6103 or email
address: mhmodel@cms.hhs.gov. The Center for Medicare and Medicaid
Innovation Web site is at https://innovation.cms.gov/.
SUPPLEMENTARY INFORMATION:
I. Background
The Center for Medicare and Medicaid Innovation (Innovation
Center), within the Centers for Medicare & Medicaid Services (CMS), was
created to test innovative payment and service delivery models to
reduce program expenditures while preserving or enhancing the quality
of care for Medicare, Medicaid, and Children's Health Insurance Program
beneficiaries.
We are interested in models designed to improve care for specific
populations. One population is Medicare fee-for service (FFS)
beneficiaries 18 to 79 years of age who have never had a heart attack
or stroke and who are not under hospice care. Current evidence suggests
that preventive cardiovascular disease interventions can significantly
reduce both adverse cardiovascular-related outcomes and death. The
Million Hearts[supreg] Cardiovascular Risk Reduction Model (hereinafter
referred to as ``CVD Risk Reduction Model'') seeks to test whether
providing incentives for physician practices to calculate absolute 10-
year cardiovascular risk reduction, measured by the American College of
Cardiology/American Heart Association (ACC/AHA) 10-year pooled cohort
risk calculator, is effective in reducing heart attacks and strokes
among Medicare FFS beneficiaries. Intervention group practices will
engage in shared decision making, team-based care, and population
health management to reduce beneficiaries' absolute risk. Intervention
group practices will be required to submit quality data to CMS
supported by a per-beneficiary-per-month payment.
The Innovation Center is operating this model under the authority
of section 1115A of the Social Security Act (the act) (42 U.S.C. 1315a)
(as added by section 3021 of the Patient Protection and Affordable Care
Act (Pub. L. 111-148), as amended by the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152), (collectively known as
Affordable Care Act)). We will evaluate whether this model reduces the
occurrence of heart attacks and strokes as well as Medicare
expenditures and enhances the quality of care furnished to Medicare
beneficiaries.
II. Provisions of the Notice
The RFA is directed to physician practices that include private
practices, hospital-owned physician practices, large medical networks,
hospital/physician organization, or independent practice associations.
Up to 720 practices are expected to participate. Participating
practices must meet the following requirements:
Practices must have at least one practitioner.
Practitioners are defined as Medical Doctors, Doctors of Osteopathic
Medicine, Physician Assistants, and Nurse Practitioners.
Practices must be using an Office of the National
Coordinator for Health Information Technology (ONC) certified
electronic health record (EHR) system.
Participating physicians or other eligible professionals
within the practice must have met the criteria for the Medicare EHR
Incentive Programs in performance year 2015, also known as ``meaningful
use,'' of an ONC certified electronic health record.
Practices selected to participate will be randomized to the
intervention group or the control group. Practices randomized to the
control group will be required to submit data to CMS at the beginning
of the first, second, third and fifth years of the model. Control group
practices will receive a one-time payment of $20 per-beneficiary
following the successful transmission of data to CMS on eligible
beneficiaries within their practices. Practices randomized to the
control group will receive no further funding beyond this one-time
payment.
Practices randomized to the intervention group will be paid a one-
time upfront payment of $10 per-beneficiary to conduct initial risk
stratification for eligible beneficiaries in addition to a $10 per-
beneficiary-per-month fee for ongoing monitoring of high-risk FFS
Medicare beneficiaries. Starting in the second year of the model, the
$10 per-beneficiary-per-month ongoing fee is gradually placed at risk
based on a practice's performance managing its ``high-risk''
beneficiaries.
Intervention group practices in the CVD Risk Reduction Model will
use the ACC/AHA Atherosclerotic Cardiovascular Disease (ASCVD) 10-year
pooled cohort risk calculator to risk stratify Medicare FFS
beneficiaries 18 to 79 years of age meeting the inclusion criteria.
Practices will further identify whether beneficiaries are ``high-risk''
defined by their 10-year ASCVD risk score: A ``high risk,'' beneficiary
is defined as a beneficiary with an ACC/AHA 10-year ASCVD risk score
greater than or equal to 30 percent. Once the high risk beneficiaries
have been identified, intervention group practices will engage in risk
modification and report process and outcome measures of their results.
Practices will be required to submit annual data to CMS through a
certified Data Registry, which will be provided to participating
practices by CMS.
The CVD Risk Reduction Model period of performance is 5 years.
Selected practices will enter into Model Participant Agreements with
CMS. Applicants must present evidence that the applicant practices are
capable of successfully identifying beneficiaries who meet the CVD Risk
Reduction Model eligibility requirements.
[[Page 31041]]
Applicants must also demonstrate their plans for engaging in shared
decision making activities with their beneficiaries. Applicants are
required to submit to CMS general beneficiary data, the clinical
indicators needed to calculate the 10-year ASCVD risk score, and the
cardiovascular Physician Quality Reporting System (PQRS) measures as
outlined in the RFA. Eligible practices will be selected on a first
come, first served basis until all 720 spots have been filled.
Applications must be submitted timely in the standard format outlined
in the CVD Risk Reduction Model RFA in order to be considered for
review. Applications that are not received in this format will not be
considered for review.
For more specific details regarding the CVD Risk Reduction Model
(including the RFA), we refer applicants to the informational materials
on the Innovation Center Web site at: https://innovation.cms.gov/initiatives/Million-Hearts-CVDRRM/. Applicants are responsible for
monitoring the Web site to obtain the most current information
available.
III. Collection of Information Requirements
Section 1115A(d)(3) of the Social Security Act states that chapter
35 of title 44, United States Code (the Paperwork Reduction Act of
1995), shall not apply to the testing and evaluation of models or
expansion of the models under this section. Consequently, there is no
need for this document to be reviewed by the Office of Management and
Budget under the authority of the Paperwork Reduction Act of 1995 (44
U.S.C. 35).
Dated: May 15, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-13042 Filed 5-28-15; 11:15 am]
BILLING CODE 4120-01-P
