Program Statutes & Regulations

Find statutes and regulatory documents describing the establishment of and further modifications to the Medicare Shared Savings Program (Shared Savings Program) through stand-alone rules and sections within the annual Physician Fee Schedule (PFS) rules. For the Shared Savings Program regulations, refer to the eCFR. For details on changes to the regulations, please refer to the Federal Register publications listed below.

Statutory Basis

Congress enacted the Patient Protection and Affordable Care Act (Pub.L. 111-148) on March 23, 2010. Section 3022 of the Affordable Care Act amended Section 1899 of the Social Security Act (the Act) and established the Shared Savings Program. To learn more, refer to the Affordable Care Act and Social Security Act.

More recently, the requirements for assignment under the program were amended by the 21st Century Cures Act (December 2016). The 21st Century Cures Act amended the Act to require the Secretary of Health and Human Services to assign beneficiaries to Accountable Care Organizations (ACOs) participating in the Shared Savings Program based not only on their utilization of primary care services furnished by physicians, but also on their utilization of services furnished by Rural Health Centers (RHCs) and Federally Qualified Health Centers (FQHCs), effective for performance years beginning on or after January 1, 2019. In addition, the Bipartisan Budget Act of 2018 (BBA of 2018) established additional tools and flexibilities for ACOs specifically in the areas of new beneficiary incentives, telehealth services, and choice of beneficiary assignment methodology.

Shared Savings Program Rule Making

2024

Physician Fee Schedule Proposed Rule

July 10, 2024

On July 10, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments, which includes proposed changes to the Shared Savings Program to further advance Medicare’s value-based care strategy of growth, alignment, and equity.

To learn more, refer to:

Significant, Anomalous, and Highly Suspect (SAHS) Billing Activity Proposed Rule

June 28, 2024

On June 28, 2024, CMS issued a proposed rule entitled Medicare Program: Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023 , which addresses policies for assessing performance year (PY) 2023 financial performance of Medicare Shared Savings Program Accountable Care Organizations (ACOs); establishing benchmarks for ACOs starting agreement periods in 2024, 2025, and 2026; and calculating factors used in the application cycle for ACOs applying to enter a new agreement period beginning on January 1, 2025, and the change request cycle for ACOs continuing their participation in the program for PY 2025, as a result of SAHS billing activity for selected intermittent urinary catheters on Medicare Durable Medical Equipment, Prosthetics, Orthotics & Supplies claims.

To learn more, refer to:

HHS Information Blocking Disincentives Final Rule

June 24, 2024

On June 24, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule that establishes disincentives for health care providers found by the HHS Office of Inspector General (OIG) to have committed information blocking—a practice of interfering with the access, exchange, or use of electronic health information. The final rule implements the HHS secretary’s authority under Section 4004 of the 21 st Century Cures Act (Cures Act). The final rule complements OIG’s rule that established information blocking penalties for the other actors identified by Congress (health information technology (IT) developers of certified health IT or other entities offering certified health IT, health information exchanges, and health information networks).

To learn more, refer to:

2023

Physician Fee Schedule Final Rule

November 2, 2023

On November 2, 2023, the CMS issued a final rule entitled Medicare and Medicaid Programs; CY 2024 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; etc., which includes changes to the Shared Savings Program to advance CMS’ overall value-based care strategy of growth, alignment, and equity.

To learn more, refer to:

HHS Information Blocking Disincentives Proposed Rule

October 30, 2023

On October 30, 2023, the HHS released a proposed rule for public comment that would establish disincentives for health care providers found by the HHS Office of Inspector General (OIG) to have committed information blocking—a practice of interfering with the access, exchange, or use of electronic health information. The proposed rule implements the HHS secretary’s authority under Section 4004 of the 21 st Century Cures Act (Cures Act). The proposed rule complements OIG’s rule that established information blocking penalties for the other actors identified by Congress (health information technology (IT) developers of certified health IT or other entities offering certified health IT, health information exchanges, and health information networks).

CMS encourages interested parties to review and submit comments on the proposed rule. Public comments on the proposed rule are due on January 2, 2024. Official comments must be submitted in one of the following ways: electronically through the Regulations.gov website, regular mail, or express or overnight mail. In commenting, please refer to file code RIN 0955-AA05.

To learn more, refer to:

Physician Fee Schedule Proposed Rule

July 13, 2023

On July 13, 2023, the CMS issued a proposed rule entitled Medicare and Medicaid Programs; CY 2024 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Continued Implementation of Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs to Provide Refunds with Respect to Discarded Amounts; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program , which includes proposed changes to the Shared Savings Program to advance CMS’ overall value-based care strategy of growth, alignment, and equity.

To learn more, refer to:

2022

Physician Fee Schedule Final Rule

November 1, 2022

On November 1, 2022, CMS issued the PFS final rule entitled Medicare and Medicaid Programs; CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements, Etc. , which includes changes to the Shared Savings Program to advance CMS’ overall value-based care strategy of growth, alignment, and equity. The Calendar Year (CY) 2023 PFS Final Rule makes regulatory changes to Shared Savings Program policies, including to: provide advance shared savings payments in the form of advance investment payments (AIPs) to certain new, low revenue ACOs that can be used to support their participation in the Shared Savings Program; provide greater flexibility in the progression to performance-based risk; establish a health equity adjustment to an ACO’s Merit-based Incentive Payment System (MIPS) quality performance category score used to determine shared savings and losses to recognize high quality performance by ACOs serving a higher proportion of underserved populations; incorporate a sliding scale reflecting an ACO’s quality performance for use in determining shared savings for ACOs, and revise the approach for determining shared losses for ENHANCED track ACOs; modify the benchmarking methodology to strengthen financial incentives for long term participation by reducing the impact of ACOs’ performance and market penetration on their benchmarks, and to support the business case for ACOs serving high risk and high dually eligible populations to participate, as well as mitigate bias in regional expenditure calculations for ACOs electing prospective assignment; expand opportunities for certain low revenue ACOs participating in the BASIC track to share in savings; make changes to policies within other programmatic areas, including the program’s beneficiary assignment methodology, requirements related to marketing material review and beneficiary notifications, the Skilled Nursing Facility (SNF) 3-day rule waiver application, and data sharing requirements.

To learn more, refer to:

July 7, 2022

On July 7, 2022, CMS issued a proposed rule entitled Medicare and Medicaid Programs: Calendar Year 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies, Medicare Shared Savings Program Requirements, etc., which includes proposed changes to the Shared Savings Program to advance CMS’ overall value-based care strategy of growth, alignment, and equity.

To learn more, refer to:

2022

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Physician Fee Schedule Final Rule

November 1, 2022

On November 1, 2022, CMS issued the PFS final rule entitled Medicare and Medicaid Programs; CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements, Etc. , which includes changes to the Shared Savings Program to advance CMS’ overall value-based care strategy of growth, alignment, and equity. The Calendar Year (CY) 2023 PFS Final Rule makes regulatory changes to Shared Savings Program policies, including to: provide advance shared savings payments in the form of advance investment payments (AIPs) to certain new, low revenue ACOs that can be used to support their participation in the Shared Savings Program; provide greater flexibility in the progression to performance-based risk; establish a health equity adjustment to an ACO’s Merit-based Incentive Payment System (MIPS) quality performance category score used to determine shared savings and losses to recognize high quality performance by ACOs serving a higher proportion of underserved populations; incorporate a sliding scale reflecting an ACO’s quality performance for use in determining shared savings for ACOs, and revise the approach for determining shared losses for ENHANCED track ACOs; modify the benchmarking methodology to strengthen financial incentives for long term participation by reducing the impact of ACOs’ performance and market penetration on their benchmarks, and to support the business case for ACOs serving high risk and high dually eligible populations to participate, as well as mitigate bias in regional expenditure calculations for ACOs electing prospective assignment; expand opportunities for certain low revenue ACOs participating in the BASIC track to share in savings; make changes to policies within other programmatic areas, including the program’s beneficiary assignment methodology, requirements related to marketing material review and beneficiary notifications, the Skilled Nursing Facility (SNF) 3-day rule waiver application, and data sharing requirements.

To learn more, refer to:

2021

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Physician Fee Schedule Final Rule

November 2, 2021

On November 2, 2021, CMS issued a final rule entitled CY 2022 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-payment Medical Review Requirements (herein CY 2022 PFS Final Rule). The CY 2022 PFS Final Rule includes regulatory changes to the Medicare Shared Savings Program including a longer transition for ACOs to report electronic clinical quality measures/Merit-based Incentive Payment System clinical quality measures (eCQM/MIPS CQM) by extending the CMS Web Interface collection type through PY 2024 and maintaining the quality performance standard ACOs must meet to be eligible to share in savings for PY 2023; updates to the definition of primary care services used in beneficiary assignment; revisions to the methodology for calculating repayment mechanism amounts for risk-based ACOs that reduces the amount by 50 percent and clarifies how we identify the number of assigned beneficiaries used in the repayment mechanism calculations; and reduces burden and streamlines the application and beneficiary notification processes. These changes to the Shared Savings Program are described in further detail via the links below.

To learn more, refer to:

Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Proposed Rule Proposes to Allow ACOs to “Freeze” Participation on BASIC Track Glide Path for PY 2022

April 27, 2021

On April 27, 2021, CMS issued a proposed rule, entitled “Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Rates Proposed Rule (CMS-1752-P)”, that includes a proposal to allow eligible ACOs participating in the BASIC track’s glide path option to elect to forgo automatic advancement along the glide path’s increasing levels of risk and potential reward for PY 2022.

To learn more, refer to:

Physician Fee Schedule Proposed Rule

July 13, 2021

On July 13, 2021, CMS issued a proposed rule entitled Medicare Program: CY 2022 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; "Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-payment Medical Review Requirements" (herein CY 2022 PFS proposed rule).

The CY 2022 PFS proposed rule includes proposals for the Shared Savings Program and QPP.

Proposals to amend Shared Savings Program policies are discussed, primarily, in section III.J.

To learn more, refer to:

Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Rates Final Rule

August 2, 2021

On August 2, 2021, CMS issued the final rule for Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Prospective Payment System (PPS) that includes policies to allow eligible ACOs participating in the BASIC track’s glide path the option to elect to forgo automatic advancement along the glide path’s increasing levels of risk and potential reward for PY 2022.

To learn more, refer to:

2020

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Physician Fee Schedule Final Rule

December 1, 2020

On December 1, 2020, CMS issued the Medicare Physician Fee Schedule final rule that includes regulatory changes to the Shared Savings Program; including, changes to the Shared Savings Program quality performance standard and quality reporting requirements for performance years beginning on January 1, 2021, to align with Meaningful Measures, reduce reporting burden and focus on patient outcomes. CMS finalized the proposal to waive the requirement for ACOs to field a Consumer Assessment of Healthcare Providers and Systems (CAHPS®) for ACOs patient experience of care surveys and ACOs will receive automatic full credit for the patient experience of care measures. The final rule also includes other changes to the Shared Savings Program that are described in further detail via the links below.

To learn more, refer to:

Physician Fee Schedule Proposed Rule

August 4, 2020

To learn more, refer to:

Interim Final Rule with Comment Released Announcing Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency

April 30, 2020

On April 30, 2020, CMS made changes to the Shared Savings Program to give the 517 ACOs serving more than 11 million beneficiaries greater financial stability and predictability during the coronavirus disease 2019 (COVID-19) pandemic.

Because the impact of the pandemic varies across the country, CMS is making adjustments to the financial methodology to account for COVID-19 costs so that ACOs will be treated equitably regardless of the extent to which their patient populations are affected by the pandemic. CMS is also forgoing the annual application cycle for 2021 and giving ACOs whose participation is set to end this year the option to extend for another year. ACOs that are required to increase their financial risk over the course of their current agreement period in the program will have the option to maintain their current risk level for next year, instead of being advanced automatically to the next risk level.

ACOs and their participating health care providers are using telehealth visits to continue to coordinate and deliver high quality care to their assigned beneficiaries. Consequently, for PY 2020 and any subsequent performance year that starts during the public health emergency, CMS is including additional codes within the definition of primary care services used in determining beneficiary assignment under the Shared Savings Program so CMS can appropriately assign beneficiaries to ACOs based on remotely provided primary care services.

For more information, refer to the following:

Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency

March 30, 2020

On March 30, 2020, CMS released the Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 public health emergency (PHE) interim final rule with comment period. This Interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare beneficiaries needed flexibilities to respond effectively to the public health threats posed by the spread of the COVID-19. In the IFC, CMS finalized a modification to the extreme and uncontrollable circumstances policy under the Shared Savings Program (See pages 129-135 of the IFC).

To learn more, refer to the following

2019

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Physician Fee Schedule Final Rule

November 1, 2019

The Medicare PFS final rule published in November 2019 includes updates to payment policies and payment rates for services furnished under the PFS on or after January 1, 2020. The rule also includes finalized policies for the Shared Savings Program and Year 4 (2020) of the QPP. CMS finalized the following refinements to the Shared Savings Program measure set:

Reverting ACO-43: Ambulatory Sensitive Condition Acute Composite Prevention Quality Indicator (PQI) #91 (version with additional risk adjustment) measure to pay-for-reporting for PY 2020 and PY 2021 due to a substantive change made by the measure owner. Maintaining ACO-17: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention as pay-for-reporting for PY 2019 as the QPP is finalizing a substantive change to the numerator guidance for the measure. Finalizing the technical change to correct a cross-reference within a provision of the Shared Savings Program’s regulations on the SNF 3-Day Rule Waiver, to conform with amendments to § 425.612 that were adopted in the December 2018 Final Rule.

For more information, refer to the following:

Proposed Rule

July 29, 2019

For more information, refer to the following:

2018

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Shared Savings Program Final Rule

December 31, 2018

On December 31, 2018, CMS published a final rule that sets a new direction for the Shared Savings Program. Referred to as “Pathways to Success,” the final rule streamlines and redesigns the participation options available under the Shared Savings Program to encourage ACOs to transition to performance-based risk more gradually and incrementally to increase savings for the Trust Funds. The policies also include changes to address the additional tools and flexibilities for ACOs established by the BBA of 2018, specifically in the areas of new beneficiary incentives, telehealth services, and choice of beneficiary assignment methodology.

For more information, refer to the following:

Physician Fee Schedule Final Rule

November 23, 2018

The PFS final rule published in November 2018 addresses a subset of changes to the Shared Savings Program for ACOs proposed in the August 2018 proposed rule “Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations Pathways to Success” and addresses various other revisions designed to update program policies under the Shared Savings Program. In order to ensure continuity of participation, finalize time-sensitive program policy changes for currently participating ACOs, and streamline the ACO core quality measure set to reduce burden and encourage better outcomes, CMS is finalizing the following policies:

Proposed Rule

August 9, 2018

Proposed Rule

July 12, 2018

To learn more, refer to CY 2019 PFS.

2017

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Shared Savings Program Interim Final Rule for Extreme and Uncontrollable Circumstances

December 26, 2017

CMS published an IFC that established policies for assessing the quality and financial performance of Shared Savings Program ACOs affected by extreme and uncontrollable circumstances, such as Hurricanes Harvey, Irma, Maria, and the California wildfires, during PY 2017. The IFC includes the following:

CMS will use the same determination of geographic areas impacted by an extreme and uncontrollable circumstance as the QPP. ACOs with 20 percent or more of their assigned beneficiaries who reside in impacted counties, or an ACO legal entity located in impacted counties, will receive the higher of their ACO reported quality score or the mean Shared Savings Program ACO quality score. Performance-based risk ACOs will have any owed losses adjusted for the percent of the ACO’s assigned beneficiaries residing in impacted counties and the length of the emergency declaration.

Physician Fee Schedule Final Rule

November 15, 2017

The PFS final rule published in November 2017 includes the following:

Proposed Rule

July 21, 2017

2016

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Physician Fee Schedule Final Rule

November 15, 2016

The PFS final rule published in November 2016 included the following:

Proposed Rule

July 15, 2016

Shared Savings Program Final Rule

June 10, 2016

The new final rule published in June 2016 included the following:

To learn more, refer to:

Proposed Rule

February 3, 2016

To learn more, refer to:

2015

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Physician Fee Schedule Final Rule

November 16, 2015

The PFS final rule published in November 2015 included the following:

Proposed Rule

July 15, 2015

Shared Savings Program Final Rule

June 9, 2015

The final rule improves several program areas including:

To learn more, refer to:

2014

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Proposed Rule

December 8, 2014

2011

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Shared Savings Program Final Rule

November 2, 2011

Proposed Rule

April 7, 2011

Other Regulations

To learn more about other applicable regulations, refer to the resources below: