CMS Invites Feedback on Medicare Data Collection Plans
Published Date: 12/30/2025
Notice
Summary
The Centers for Medicare & Medicaid Services (CMS) wants your thoughts on their plan to collect info from the public. This helps make sure the questions they ask are useful and not too much work. You’ve got until January 28, 2026, to share your ideas, so don’t miss out on shaping how this info is gathered!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Medicare Coverage for IDE Study Costs
Under Section 1862(m) of the Social Security Act and 42 CFR Subpart B (sections 405.201-405.215), Medicare may pay routine costs of care for Medicare beneficiaries in FDA investigational device exemption (IDE) Category A studies, but Medicare does not cover the experimental Category A device itself. Medicare may cover Category B (non-experimental) devices and associated routine costs if they are reasonable and necessary and all other Medicare coverage requirements are met.
CMS IDE Data Collection Burden
If you are a study sponsor or similar private-sector organization, CMS is extending an annual information collection using Form CMS-10511 (OMB control number 0938-1250). The collection is yearly, lists 118 respondents with 118 total annual responses, and carries a total burden of 236 hours per year; submissions can include an FDA IDE approval letter, IDE study protocol, IRB approval letter, National Clinical Trials (NCT) number, and supporting materials.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-10890 — Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model
Starting July 1, 2026, Medicare is updating the Increasing Organ Transplant Access (IOTA) Model to help kidney transplant hospitals do even better at getting more people transplanted and improving care quality. These changes affect hospitals involved in kidney transplants and aim to make the process smoother and more effective, with new payment rules that reward success. This update is part of a 6-year plan running through 2031 to save more lives and boost patient experience.
2026-10292 — Medicaid Program; Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments
This proposed rule changes how states can pay Medicaid managed care plans and certain doctors to make sure payments are fair, efficient, and encourage enough providers to offer quality care. It affects states, Medicaid managed care organizations, and targeted Medicaid practitioners, aiming to keep payments balanced and services available. Comments on these changes are open until July 21, 2026, so stakeholders have time to weigh in before it’s finalized.
2026-10050 — Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program
Starting in 2027, health insurance plans on federal and state marketplaces will see new rules to make coverage fairer and easier to use. These changes affect insurance companies, agents, and people buying plans, including new fees, penalties, and better protections for those with hardships. Expect updates on plan quality, dental coverage limits, and longer-term catastrophic plans, all aiming to keep your health coverage solid and affordable.
2026-07205 — Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges
This new rule will help Medicare, Medicaid, CHIP, and health plan companies share patient info more easily and speed up drug approval requests. It affects Medicare Advantage, Medicaid, CHIP, and health plans on federal exchanges, aiming to make care smoother and faster. These changes will start soon and could save time and money by cutting red tape.
2026-04797 — Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction
This document fixes some typos and technical mistakes in the Medicare and Medicaid payment rules for 2026. It affects doctors, healthcare providers, and anyone using Medicare Part B by clarifying payment policies and program requirements starting January 1, 2026. These corrections help make sure payments and coverage rules are clear and accurate, so everyone gets paid right and on time.
2026-04467 — Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program; Correction
This correction fixes some missing labels in important tables from the 2027 health insurance rules under the Affordable Care Act. It mainly affects insurance companies and people using marketplace plans by clarifying how risk and payments are calculated. These fixes take effect right away on March 6, 2026, ensuring everyone has clear info before the 2027 plan year starts.
Previous / Next Documents
Previous: 2025-23922 — Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Certification and Compliance Requirements for Nonroad Spark-Ignition Engines (Renewal)
The EPA is asking to keep collecting info on small engines like lawnmowers and generators to make sure they meet pollution rules. This renewal keeps the paperwork going through 2028, with no big changes or extra costs expected. If you have thoughts, you’ve got until January 28, 2026, to speak up!
Next: 2025-23924 — Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) wants your feedback on their plan to collect some info from the public. This helps them follow rules that make sure they don’t ask for too much paperwork. If you have thoughts, send them by March 2, 2026—your input could help save time and effort for everyone!