80 FR 31040 - Medicare Program; Announcement of Request for Applications for the Million Hearts® Cardiovascular Risk Reduction Model
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 104 (June 1, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 104 (June 1, 2015)
| Page Range | 31040-31041 | |
| FR Document | 2015-13042 |
[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)] [Notices] [Pages 31040-31041] From the Federal Register Online [www.thefederalregister.org] [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: http://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: [email protected]. The Center for Medicare and Medicaid Innovation Web site is at http://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: http://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
![31040 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices
DEPARTMENT OF HEALTH AND expenditures while preserving or Information Technology (ONC) certified
HUMAN SERVICES enhancing the quality of care for electronic health record (EHR) system.
Medicare, Medicaid, and Children’s • Participating physicians or other
Centers for Medicare & Medicaid Health Insurance Program beneficiaries. eligible professionals within the
Services We are interested in models designed practice must have met the criteria for
to improve care for specific populations. the Medicare EHR Incentive Programs in
[CMS–5513–N]
One population is Medicare fee-for performance year 2015, also known as
Medicare Program; Announcement of service (FFS) beneficiaries 18 to 79 ‘‘meaningful use,’’ of an ONC certified
Request for Applications for the Million years of age who have never had a heart electronic health record.
Hearts® Cardiovascular Risk attack or stroke and who are not under Practices selected to participate will
Reduction Model hospice care. Current evidence suggests be randomized to the intervention group
that preventive cardiovascular disease or the control group. Practices
AGENCY: Centers for Medicare & interventions can significantly reduce randomized to the control group will be
Medicaid Services (CMS), HHS both adverse cardiovascular-related required to submit data to CMS at the
ACTION: Notice. outcomes and death. The Million beginning of the first, second, third and
Hearts® Cardiovascular Risk Reduction fifth years of the model. Control group
SUMMARY: This notice informs interested practices will receive a one-time
parties of an opportunity to apply for Model (hereinafter referred to as ‘‘CVD
Risk Reduction Model’’) seeks to test payment of $20 per-beneficiary
participation in the Million Hearts® following the successful transmission of
Cardiovascular Risk Reduction Model. whether providing incentives for
physician practices to calculate absolute data to CMS on eligible beneficiaries
The primary goal of this model is to test within their practices. Practices
whether encouraging physician 10-year cardiovascular risk reduction,
measured by the American College of randomized to the control group will
practices to calculate risk for all of the receive no further funding beyond this
practice’s eligible Medicare Cardiology/American Heart Association
(ACC/AHA) 10-year pooled cohort risk one-time payment.
beneficiaries, using the American Practices randomized to the
College of Cardiology/American Heart calculator, is effective in reducing heart
intervention group will be paid a one-
Association (ACC/AHA) Atherosclerotic attacks and strokes among Medicare FFS
time upfront payment of $10 per-
Cardiovascular Disease (ASCVD) 10- beneficiaries. Intervention group
beneficiary to conduct initial risk
year pooled cohort risk calculator will practices will engage in shared decision stratification for eligible beneficiaries in
prevent the occurrence of first-time making, team-based care, and addition to a $10 per-beneficiary-per-
heart attacks and strokes. population health management to month fee for ongoing monitoring of
reduce beneficiaries’ absolute risk. high-risk FFS Medicare beneficiaries.
DATES: Applications will be considered
Intervention group practices will be Starting in the second year of the model,
timely if they are received on or before
required to submit quality data to CMS the $10 per-beneficiary-per-month
September 4, 2015 as outlined in the
supported by a per-beneficiary-per- ongoing fee is gradually placed at risk
Request for Applications (RFA).
month payment. based on a practice’s performance
Note: Interested applicants will be required The Innovation Center is operating
to submit a non-binding Letter of Intent (LOI) managing its ‘‘high-risk’’ beneficiaries.
this model under the authority of Intervention group practices in the
to apply for the model.
section 1115A of the Social Security Act CVD Risk Reduction Model will use the
ADDRESSES: All LOIs must be submitted (the act) (42 U.S.C. 1315a) (as added by ACC/AHA Atherosclerotic
electronically through the Center for section 3021 of the Patient Protection Cardiovascular Disease (ASCVD) 10-
Medicare and Medicaid Innovation Web and Affordable Care Act (Pub. L. 111– year pooled cohort risk calculator to risk
site at: http://innovation.cms.gov/ 148), as amended by the Health Care stratify Medicare FFS beneficiaries 18 to
initiatives/Million-Hearts-CVDRRM/. and Education Reconciliation Act of 79 years of age meeting the inclusion
LOIs will be accepted throughout the 2010 (Pub. L. 111–152), (collectively criteria. Practices will further identify
entire application period, ending known as Affordable Care Act)). We will whether beneficiaries are ‘‘high-risk’’
September 4, 2015. Applicants will evaluate whether this model reduces the defined by their 10-year ASCVD risk
need to use their LOI confirmation occurrence of heart attacks and strokes score: A ‘‘high risk,’’ beneficiary is
number to access the RFA. All as well as Medicare expenditures and defined as a beneficiary with an ACC/
applicants will receive a RFA enhances the quality of care furnished AHA 10-year ASCVD risk score greater
submission confirmation number; it is to Medicare beneficiaries. than or equal to 30 percent. Once the
the applicant’s responsibility to retain a high risk beneficiaries have been
II. Provisions of the Notice
copy of the confirmation number for identified, intervention group practices
proof of submission. The RFA is directed to physician will engage in risk modification and
FOR FURTHER INFORMATION CONTACT: practices that include private practices, report process and outcome measures of
Nina Brown at (410) 786–6103 or email hospital-owned physician practices, their results. Practices will be required
address: mhmodel@cms.hhs.gov. The large medical networks, hospital/ to submit annual data to CMS through
Center for Medicare and Medicaid physician organization, or independent a certified Data Registry, which will be
Innovation Web site is at http:// practice associations. Up to 720 provided to participating practices by
innovation.cms.gov/. practices are expected to participate. CMS.
SUPPLEMENTARY INFORMATION: Participating practices must meet the The CVD Risk Reduction Model
following requirements: period of performance is 5 years.
I. Background
Lhorne on DSK2VPTVN1PROD with NOTICES
• Practices must have at least one Selected practices will enter into Model
The Center for Medicare and practitioner. Practitioners are defined as Participant Agreements with CMS.
Medicaid Innovation (Innovation Medical Doctors, Doctors of Osteopathic Applicants must present evidence that
Center), within the Centers for Medicare Medicine, Physician Assistants, and the applicant practices are capable of
& Medicaid Services (CMS), was created Nurse Practitioners. successfully identifying beneficiaries
to test innovative payment and service • Practices must be using an Office of who meet the CVD Risk Reduction
delivery models to reduce program the National Coordinator for Health Model eligibility requirements.
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![Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices 31041
Applicants must also demonstrate their DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
plans for engaging in shared decision HUMAN SERVICES Tong Zhou, Center for Veterinary
making activities with their Medicine (HFV–153), Food and Drug
beneficiaries. Applicants are required to Food and Drug Administration Administration, 7500 Standish Pl.,
submit to CMS general beneficiary data, Rockville, MD 20855, 240–402–0826,
[Docket No. FDA–2015–D–1804]
the clinical indicators needed to Tong.Zhou@fda.hhs.gov.
calculate the 10-year ASCVD risk score, International Cooperation on SUPPLEMENTARY INFORMATION:
and the cardiovascular Physician Harmonisation of Technical I. Background
Quality Reporting System (PQRS) Requirements for Registration of
Veterinary Medicinal Products; Studies FDA is announcing the availability of
measures as outlined in the RFA.
To Evaluate the Safety of Residues of a draft guidance for industry #232
Eligible practices will be selected on a entitled ‘‘Studies to Evaluate the Safety
first come, first served basis until all 720 Veterinary Drugs in Human Food:
General Approach To Establish an of Residues of Veterinary Drugs in
spots have been filled. Applications Human Food: General Approach to
must be submitted timely in the Acute Reference Dose; Draft Guidance
for Industry; Availability Establish an Acute Reference Dose
standard format outlined in the CVD (ARfD)’’ (VICH GL54). In recent years,
Risk Reduction Model RFA in order to AGENCY: Food and Drug Administration, many important initiatives have been
be considered for review. Applications HHS. undertaken by regulatory authorities
that are not received in this format will ACTION: Notice. and industry associations to promote
not be considered for review. the international harmonization of
For more specific details regarding the SUMMARY: The Food and Drug regulatory requirements. FDA has
CVD Risk Reduction Model (including Administration (FDA or Agency) is participated in efforts to enhance
the RFA), we refer applicants to the announcing the availability of a draft harmonization and has expressed its
informational materials on the guidance for industry (GFI) #232 commitment to seek scientifically based
entitled ‘‘Studies to Evaluate the Safety harmonized technical procedures for the
Innovation Center Web site at: http://
of Residues of Veterinary Drugs in development of pharmaceutical
innovation.cms.gov/initiatives/Million-
Human Food: General Approach to products. One of the goals of
Hearts-CVDRRM/. Applicants are harmonization is to identify, and then
Establish an Acute Reference Dose
responsible for monitoring the Web site reduce, differences in technical
(ARfD)’’ (VICH GL54). This draft
to obtain the most current information guidance has been developed for requirements for drug development
available. veterinary use by the International among regulatory agencies in different
III. Collection of Information Cooperation on Harmonisation of countries.
Technical Requirements for Registration FDA has actively participated in the
Requirements
of Veterinary Medicinal Products International Conference on
Section 1115A(d)(3) of the Social (VICH). This draft VICH guidance Harmonisation of Technical
Security Act states that chapter 35 of document is intended to address the Requirements for Registration of
title 44, United States Code (the nature and types of data that can be Pharmaceuticals for Human Use (ICH)
Paperwork Reduction Act of 1995), shall useful in determining an ARfD for for several years to develop harmonized
not apply to the testing and evaluation residues of veterinary drugs, the studies technical requirements for the approval
that may generate such data, and how of human pharmaceutical and biological
of models or expansion of the models
the ARfD may be calculated based on products among the European Union,
under this section. Consequently, there
these data. Japan, and the United States. The VICH
is no need for this document to be is a parallel initiative for veterinary
reviewed by the Office of Management DATES: Although you can comment on
medicinal products. The VICH is
and Budget under the authority of the any guidance at any time (see 21 CFR concerned with developing harmonized
Paperwork Reduction Act of 1995 (44 10.115(g)(5)), to ensure that the Agency technical requirements for the approval
U.S.C. 35). considers your comment on this draft of veterinary medicinal products in the
guidance before it begins work on the European Union, Japan, and the United
Dated: May 15, 2015.
final version of the guidance, submit States, and includes input from both
Andrew M. Slavitt, either electronic or written comments regulatory and industry representatives.
Acting Administrator, Centers for Medicare on the draft guidance by July 31, 2015. The VICH Steering Committee is
& Medicaid Services. ADDRESSES: Submit written requests for composed of member representatives
[FR Doc. 2015–13042 Filed 5–28–15; 11:15 am] single copies of the draft guidance to the from the European Commission;
BILLING CODE 4120–01–P Policy and Regulations Staff (HFV–6), European Medicines Evaluation Agency;
Center for Veterinary Medicine, Food European Federation of Animal Health;
and Drug Administration, 7519 Standish Committee on Veterinary Medicinal
Pl., Rockville, MD 20855. Send one self- Products; FDA; the U.S. Department of
addressed adhesive label to assist that Agriculture; the Animal Health
office in processing your request. See Institute; the Japanese Veterinary
the SUPPLEMENTARY INFORMATION section Pharmaceutical Association; the
for electronic access to the draft Japanese Association of Veterinary
guidance document. Biologics; and the Japanese Ministry of
Lhorne on DSK2VPTVN1PROD with NOTICES
Submit electronic comments on the Agriculture, Forestry, and Fisheries.
draft guidance to http:// Six observers are eligible to
www.regulations.gov. Submit written participate in the VICH Steering
comments to the Division of Dockets Committee: One representative from the
Management (HFA–305), Food and Drug government of Australia/New Zealand,
Administration, 5630 Fishers Lane, Rm. one representative from the industry in
1061, Rockville, MD 20852. Australia/New Zealand, one
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Document Created: 2015-12-15 15:18:26
Document Modified: 2015-12-15 15:18:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Applications will be considered timely if they are received on or before September 4, 2015 as outlined in the Request for Applications (RFA). | |
| Contact | Nina Brown at (410) 786-6103 or email | |
| FR Citation | 80 FR 31040 |
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