The Centers for Medicare & Medicaid Services CMS, an agency within the Department of Health and Human Services HHS, has issued a notice in the Federal Register inviting public comment on two distinct yet significant information collection activities. This action is undertaken in compliance with the Paperwork Reduction Act of 1995 PRA, which mandates federal agencies provide opportunities for public input on proposed and existing information collections.
This 30-day comment period, ending July 16, 2026, concerns the reinstatement without change of two previously approved collections. These collections are integral to CMS's ongoing efforts to ensure the quality of healthcare services, protect consumers from unexpected costs, and maintain the integrity of federal health programs.
The Paperwork Reduction Act and Public Input
Under the PRA, federal agencies must demonstrate that their information collection requests are necessary, minimize burden on the public, and contribute to the proper performance of agency functions. By publishing these notices, CMS provides a structured avenue for stakeholders to voice concerns or offer suggestions regarding the accuracy of burden estimates, ways to enhance data quality and clarity, and opportunities for using automated collection techniques.
This mechanism allows for ongoing dialogue between the government and the public, ensuring that regulatory requirements remain relevant and efficient. The current notice specifically calls for comments on the utility and necessity of the information being collected, reflecting the PRA's core objective of preventing unnecessary governmental demands for information.
Ensuring Quality in Portable X-ray Services
One of the information collections CMS is seeking comment on, identified as CMS-R-43 OMB Control Number 0938-0338, is titled "Conditions of Coverage for Portable X-ray Suppliers and Supporting Regulations." This collection is a reinstatement without change, indicating its established role in federal oversight.
The purpose of CMS-R-43 is to ensure that portable X-ray suppliers meet specific health and safety requirements outlined in Title 42 Code of Federal Regulations Section 486, Subpart C. These services are crucial for vulnerable populations, including residents of Skilled Nursing Facilities SNFs, Long-Term Care Facilities LTCs, and homebound individuals who cannot easily travel to outpatient radiology facilities.
Compliance with these regulations is a prerequisite for suppliers to receive payment for services from the Medicare and Medicaid programs. The information collected enables CMS to monitor and verify supplier adherence to these critical health and safety standards. The collection affects approximately 540 businesses or other for-profit and not-for-profit institutions, with an estimated 1,080 annual responses and 340 total annual hours of burden.
Advancing Transparency in Healthcare Costs: The Surprise Billing Rules
The second information collection, CMS-10791 OMB Control Number 0938-1433, is titled "Requirements Related to Surprise Billing; Part II." This collection, also a reinstatement without change, is directly associated with the interim final rules published on October 7, 2021 86 FR 55980. These rules are part of a broader federal initiative to protect consumers from unexpected medical bills, particularly those arising from out-of-network care.
Good Faith Estimates for Uninsured Individuals
A key component of CMS-10791 relates to "Good Faith Estimates" GFEs. Providers and facilities are required to inform uninsured or self-pay individuals of their right to receive a GFE of expected charges for items and services. Furthermore, they must furnish these GFEs to uninsured or self-pay individuals for scheduled services and upon request.
The intent behind this requirement is multifaceted. GFEs provide individuals with crucial information about healthcare pricing prior to receiving care, empowering them to evaluate options, make cost-conscious decisions, and mitigate the incidence of surprise medical bills. Moreover, a GFE is a necessary prerequisite for uninsured or self-pay individuals to initiate the patient-provider dispute resolution process if they believe they have been overcharged.
Certification of Selected Dispute Resolution Entities
The second component of CMS-10791 concerns the "Certification and Recertification of SDR Entities." HHS requires information from entities seeking to be certified or recertified as Selected Dispute Resolution SDR entities. These entities play a vital role in arbitrating payment disputes between providers and health plans under the No Surprises Act.
To ensure impartiality and competence, applicants must submit detailed information on their organizational structure, policies and procedures, staff qualifications, conflict-of-interest safeguards, and operational capacity. They must also provide attestations of compliance with applicable standards. This rigorous information collection allows HHS to determine an entity's eligibility and capability to perform SDR functions effectively and impartially, thereby upholding the integrity of the dispute resolution process.
The scale of this collection is considerably larger than that for portable X-ray suppliers, affecting approximately 511,749 private sector entities with an estimated 5,248,414 annual responses and a substantial 3,498,944 total annual hours of burden.
Broader Implications for Healthcare Oversight
These two information collections, while disparate in their immediate subject matter, underscore CMS's ongoing commitment to robust oversight within the healthcare system. The Portable X-ray Supplier collection speaks to foundational concerns of patient safety and service quality, particularly for vulnerable populations reliant on Medicare and Medicaid.
The Surprise Billing collection, on the other hand, reflects a newer, yet equally critical, regulatory push towards greater transparency and consumer protection in an increasingly complex healthcare financing landscape. The "reinstatement without change" status of both collections suggests that the current frameworks are considered effective and necessary, but the public comment period offers an opportunity for stakeholders to suggest refinements or highlight unforeseen challenges in their practical application.
For providers, the continuous requirement to collect and submit this information necessitates robust internal processes and adherence to evolving federal mandates. For patients, particularly those uninsured or receiving portable services, these collections contribute to safeguards designed to ensure both the quality and affordability of their care. The continued data collection allows CMS to monitor compliance and impact, informing future policy decisions and adjustments.
