What Is a CMS Proposed Rule? Understanding the First Step in Medicare Policy Changes
Every year, wound care professionals hear about major CMS proposed rules that could affect payment, coding, quality reporting, and coverage policies. But what exactly is a proposed rule, and how does it become Medicare policy? This explainer breaks down the federal rulemaking process and explains why proposed rules matter—even before any changes take effect.
Key Takeaways:
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A CMS proposed rule outlines potential policy changes but does not create new requirements or payment policies on its own.
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Proposed rules are published to gather public feedback before CMS issues a final rule.
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Many Medicare payment and policy changes, including those affecting wound care services and products, begin in the proposed rule stage.
What Is a CMS Proposed Rule?
For wound care and other medical professionals, summer often marks the beginning of Medicare rulemaking season. The Centers for Medicare & Medicaid Services (CMS) typically releases proposed updates to major payment systems, including the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS). These documents can span thousands of pages and generate significant discussion throughout the health care industry.
But despite the attention they receive, a CMS proposed rule is not yet Medicare policy.
A proposed rule is CMS's formal announcement that it intends to create, revise, or remove a regulation or payment policy. Published in the Federal Register, the proposed rule describes the agency's planned changes and explains the rationale behind them. Importantly, it also invites feedback from stakeholders through a public comment period.¹
Under the federal rulemaking process established by the Administrative Procedure Act, agencies generally must provide notice of proposed regulatory changes and allow interested parties an opportunity to comment before issuing a final rule.² For Medicare regulations, CMS typically provides at least a 60-day public comment period for significant proposed rules.³
During this comment period, health care providers, professional societies, manufacturers, patient advocacy groups, and members of the public may submit feedback through Regulations.gov or other channels identified by CMS. CMS reviews these comments and may modify its proposals before issuing a final rule.¹,³
This is one reason proposed rules often differ from final rules. Stakeholder feedback, new data, legal considerations, and operational concerns may lead CMS to revise or withdraw specific proposals. In some cases, CMS may finalize a policy largely as proposed; in others, substantial changes may occur between the proposed and final versions.¹
After reviewing public comments, CMS publishes a final rule in the Federal Register. Unlike a proposed rule, a final rule establishes official Medicare policy and typically includes an effective date indicating when the changes will take effect.¹,²
For wound care stakeholders, proposed rules are important because they offer an early look at potential changes to reimbursement methodologies, quality programs, coding policies, technology payment pathways, and other Medicare initiatives. While proposed rules should not be interpreted as finalized policy, they provide valuable insight into CMS's priorities and policy direction.
Understanding the distinction between a proposed rule and a final rule can help clinicians and health care organizations follow Medicare developments with appropriate context—and avoid assuming that every proposal will ultimately become policy.
References
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Centers for Medicare & Medicaid Services. CMS Rulemaking. CMS. Updated 2024. Accessed June 23, 2026. https://www.cms.gov/medicare/regulations-guidance/cms-rulemaking (Centers for Medicare & Medicaid Services)
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Administrative Procedure Act, 5 U.S.C. §553. Accessed June 23, 2026. https://uscode.house.gov
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Social Security Act §1871(b), 42 U.S.C. §1395hh. Medicare rulemaking requirements and public comment procedures. Accessed June 23, 2026. https://www.govinfo.gov/content/pkg/FR-2025-05-29/pdf/2025-09695.pdf
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Federal Register. About the Federal Register and Federal Rulemaking Process. Accessed June 23, 2026. https://uploads.federalregister.gov/uploads/2013/09/The-Rulemaking-Process.pdf
