CMS Medicare Deregulation RFI Response

Submitted June 10, 2025

Topic 1: Streamline Regulatory Requirements

1A. Are there existing regulatory requirements (including those issued through regulations but also rules, memoranda, administrative orders, guidance documents, or policy statements), that could be waived, modified, or streamlined to reduce administrative burdens without compromising patient safety or the integrity of the Medicare program?

WEDI Comment:

WEDI is pleased to submit our comments to the Centers for Medicare & Medicaid Services (CMS) in response to the request for information (RFI) titled “Unleashing Prosperity Through Deregulation of the Medicare Program.” WEDI was formed in 1991 by then Secretary of Health and Human Services (HHS) Dr. Louis Sullivan and was designated in the Health Insurance Portability and Accountability Act (HIPAA) legislation as an advisor to HHS. As one of the leading authorities on the use of health IT to improve information exchange, our priorities are to enhance the quality of care, improve efficiency, and reduce costs in our nation’s health care system. WEDI’s membership includes a broad coalition of organizations,  including hospitals, medical and dental providers, health plans, vendors, federal and state government agencies, patient advocates, and standards development organizations. As a multi-stakeholder, consensus-building organization, WEDI offers a wealth of experience, knowledge, and history in advising HHS and educating the industry on a wide range of health information technology (IT) initiatives and federal regulatory requirements.

Please contact Robert M. Tennant, Executive Director of WEDI at 202.368.2675 or rtennant@wedi.org with any questions you may have or to explore opportunities to work together.

Consumer Pricing Tools

WEDI fully supports Medicare beneficiaries having timely and accurate pricing information to improve health care decision making. It is, however, imperative that an appropriate balance be struck between the value for consumers and the burden on stakeholders to produce and maintain this information.

While Medicare and other government health plans are not subject to the No Surprises Act (NSA), requirements of the law have introduced the potential for significant burdens on providers who care for Medicare beneficiaries and health plans that administer benefits for them. WEDI has submitted several letters to HHS and CMS making recommendations for alternative approaches to meeting the requirements established in the NSA.

Since passage of the landmark legislation the industry has had time to closely evaluate the new workflows, processes, and functions that would need to be implemented to meet the legislative requirements for generating Good Faith Estimates (GFE) for both insured and uninsured patients and Advanced Explanation of Benefits (AEOB) for insured patients. Currently, there are no existing data exchange standards that fulfill the operational requirements of the GFE, the AEOB, or the “convening provider” provisions of the law. To meet the intent of the law, WEDI recommends that CMS consider the objectives of the GFE and AEOB requirements, to provide consumers with timely and accurate cost information, and identify alternative methods to achieve these goals. For insured consumers, CMS should explore the use of online price estimator tools on publicly accessible websites where the consumer has immediate access to a broad range of accurate medical service pricing information. WEDI also urges a public-private sector collaboration to develop and test NSA data exchange standards and workflow processes. Finally, WEDI strongly recommends that CMS exercise its discretion and not enforce any NSA data exchange requirements until appropriate transactions have been identified, fully tested, and determined to function correctly.

Further, WEDI urges CMS to develop and disseminate educational materials to assist consumers in better understanding their rights under the NSA and how they can best use cost, quality, and other data to access affordable quality care. WEDI, with its multistakeholder membership, is ready and willing to collaborate with CMS on this effort.

Selective Regulation

Adoption of industry standards through a voluntary process has proven to be ineffective for the health care sector. Mandating standards and supportive operating rules have shown that the industry can successfully streamline administrative and clinical workflows, lower costs, and reduce burden. The CMS National Standards Group (NSG) and Assistant Secretary of Technology Policy (ASTP)/Office of the National Coordinator for Health Information Technology (ONC) have been very effective in collaborating with stakeholders to identify solutions, develop policy, and implement standards through regulatory action. A few examples include the implementation of the Version 4010 and 5010 X12 transactions, International Classification of Diseases, Tenth Revision (ICD-10), National Council for Prescription Drug Programs (NCPDP) pharmacy standards, CAQH Committee on Operating Rules for Information Exchange (CORE) operating rules, and certified electronic health record (EHR) technology. WEDI believes that selective regulation drives industry’s adoption of standards and innovative technologies that improve efficiency and enhance care delivery.

Since the passage of HIPAA, the industry has made significant progress in reducing burden and costs from manual administrative process. However, billions of dollars of waste have yet to be removed from the health care system, as documented in the latest CAQH Index, due to the lower usage of some transactions, such as the ones for prior authorization, claim status inquiry, and claim payment.

The current version of HIPAA transactions (Version 5010) was mandated in 2012 and by many accounts has become outdated. X12, the standards development organization for many of the HIPAA-mandated transactions, has recently implemented a new predictable schedule for updates to the transactions. It is in the process of recommending through NSG the adoption of its latest version of the standard, Version 8060. Requiring this version of transactions could spur the industry to use the transactions that have lower rates of adoption and thus facilitate cost savings to providers and health plans. WEDI has experience with assisting CMS and the industry successfully implement X12 transactions and we are ready again to assist with subject matter expertise, education, and readiness monitoring.

The regulatory process for the adoption of both new and updated versions of HIPAA-mandated administrative transactions and CAQH CORE operating rules is overly lengthy and burdensome. We strongly recommend that this process be modified to allow for a more predictable cadence that also maintains a designated public review and feedback process. Having updated transactions and operating rules will automate critical administrative functions and reduce burden and cost. We recommend updating these transactions in a process similar to updates to current HIPAA-mandated medical code sets. These include ICD-10 and Current Procedural Terminology (CPT), each of which are updated yearly on a set date. Updating standards on a regular cadence would bring significant administrative efficiency. WEDI offers our assistance to CMS in both the review and implementation of new standards and operating rules.

For the exchange of clinical data (i.e., in support of claims and prior authorization), WEDI encourages CMS to consider identifying flexible, consensus-based standards that support scalable and interoperable documentation exchange across multiple use cases. As industry standards and technologies continue to evolve, solutions that enable broad reuse will best serve providers, payers, and patients.

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1B. Which specific Medicare administrative processes or quality and data reporting requirements create the most significant burdens for providers?

WEDI Comment:

Quality and Data Reporting

There are currently numerous quality and data reporting requirements across CMS and other HHS agencies, including the Quality Payment Program (QPP), Merit-based Incentive Payment System (MIPS), Alternative Payment Models (APMs), and ONC Health IT Certification Program. These requirements heavily impact providers and the vendors that create software and tools to support the data reporting. Across these programs there are measures that are outdated (e.g., MIPS e-prescribing measure, attesting to the Stop, Access, Formulate, Execute, and Review (SAFER) guidelines), and redundant (e.g., EHR certification risk assessment and the security assessment required under HIPAA), which all lead to measure fatigue by providers.

See 1C. for suggestions on how CMS can address these burdens.

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1C. Are there specific Medicare administrative processes, quality, or data reporting requirements, that could be automated or simplified to reduce the administrative burden on facilities and other providers?

WEDI Comment:

Quality and Data Reporting

To address the issues identified in 1B., CMS should prioritize completing a cross-agency collaboration evaluation of the end-to-end processes for the current quality and data reporting requirements of providers. From that evaluation, CMS and other appropriate agencies can develop an action plan to eliminate burden and redundancy by aligning reporting needs, eliminating outdated requirements, implementing technology to support data capture and exchange, and educating providers. Throughout this process, CMS and other agencies must engage with providers and other stakeholders on the data reporting needs and how those needs can be met more efficiently.

We recommend CMS explore opportunities to reduce the number of “topped out” measures that require participating providers to collect and report numerators and denominators. The simpler approach of self-attestation for these types of measures to report that the requirements have been met can be used when more detailed quality data is unnecessary. The deployment of targeted audits by CMS would verify compliance with the requirements.

A priority of CMS should be to develop a better feedback loop to return data reporting results and analysis as quickly as possible and avoid returning feedback months later to providers. Optimally, providers should be sent the data analysis in near-real time to best implement changes to ensure improvement in their delivery of patient care.

In addition, WEDI recommends that CMS take the following steps to generally decrease data reporting burdens:

• Align quality measures and reporting requirements across CMS programs and the private sector.
• Reduce reporting requirements, where appropriate.
• Implement a data policy of “report once and reuse” to reduce the frequency in which providers report the same data for different reporting programs.
• Review for efficiency the data that providers report to health plans for use in the Medicare Advantage star ratings program and maintain a balanced measure set of member experience and clinical outcomes.
• Implement technology and processes that facilitate the ability of HHS to demonstrate that a provider has met measure reporting requirements.
• Continue the ONC EHR Certification Program to ensure providers have access to the software necessary for data collection and reporting.
• Develop educational materials for providers that demonstrate the need and value of quality and data reporting with examples of how they improve patient outcomes.

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Topic 2: Opportunities to Reduce Burden of Reporting and Documentation

2A. What changes can be made to simplify Medicare reporting and documentation requirements without affecting program integrity?

WEDI Comment:

Provider Enrollment and Credentialing

The Medicare provider enrollment, re-enrollment, and credentialing processes are overly complex and impose significant data reporting requirements on providers. The current processes for Medicare enrollment and credentialing involve paper application forms, entering the same information into multiple applications, and reporting data in alternative locations via paper, fax, or online. These processes should be streamlined. WEDI also recommends the number of times providers enter their information into the Medicare enrollment Provider Enrollment, Chain and Ownership System (PECOS) be reduced. Revising PECOS reporting requirements would bring much needed burden relief for providers.

Another example of redundant reporting requirements occurs with home infusion providers. These providers must submit their data to three different entities, which all use a different format. In addition to Medicare, providers submit similar data to other government and commercial payers. A priority should be for home infusion providers, as well as for other provider data reporting requirements, to report data once and for CMS to use it across the various applications and programs where it is needed, i.e., “report once and reuse.”

Finally, CMS should conduct an evaluation to identify the various entities collecting enrollment and credentialing information, formats and processes for data collection, manual steps, and duplicative reporting. From this evaluation, CMS can develop an action plan to eliminate any redundancy in the enrollment and credentialing processes. Providers and other stakeholders must be included in this work to ensure a complete understanding of their reporting burden.

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2B. Are there opportunities to reduce the frequency or complexity of reporting for Medicare providers?

WEDI Comment:

Provider Enrollment and Credentialing

See 2A. for opportunities to reduce the complexity of Medicare enrollment and credentialing.

Additional WEDI recommendations include:

• Offer detailed instructions for providers on where and how to report their information for enrollment and credentialing.
• Send providers their data currently on file with CMS, and then have the provider make updates and attest to the accuracy of the information.
• Reuse the provider’s enrollment data for the population of provider directory data.
• Explore the development of a national provider database to improve access to provider information in one place.

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2C. Are there documentation or reporting requirements within the Medicare program that are overly complex or redundant? If so, which ones?

WEDI Comment:

Provider Electronic Data Interchange (EDI) Enrollment

With no standard enrollment form in use, the current provider EDI enrollment process required by Medicare and other payers is overly burdensome. EDI enrollment must be completed by each provider that intends to submit electronic transactions via EDI, either directly with the payer or through a billing service or clearinghouse. Data captured in the form and the process for submitting forms vary across payers. Streamlining the enrollment requirements would greatly reduce the administrative burden on providers.

The need to streamline the EDI enrollment process became widely apparent following the February 2024 cyberattack on Change Healthcare. Following the attack, data exchange processes vital for patient care, such as verifying insurance eligibility, obtaining prior authorization, submitting claims, and receiving payment, were significantly disrupted. Establishing alternative data exchange pathways proved to be challenging and protracted, leading to significant delays in re-routing critical transactions. In addition to streamlining the current enrollment process, WEDI recommends CMS establish an emergency process that can be deployed during a significant cyberattack or other debilitating event and expedite EDI enrollment. WEDI would be pleased to work with CMS on this project.

In addition, specific to federal government payers, the process for EDI enrollment needs to be standardized and centralized so that one enrollment form can be used across all payers. The EDI enrollment data once attested to by the provider and submitted to Medicare or another government payer should be used across all government payers. We also recommend CMS implement the X12 Trading Partner Profile (838) transaction to standardize data collection and exchange.

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Topic 3: Identification of Duplicative Requirements

3A. Which specific Medicare requirements or processes do you consider duplicative, either within the program itself, or with other healthcare programs (including Medicaid, private insurance, and state or local requirements)?

WEDI Comment:

See responses to 2A., 2B., and 2C. on provider enrollment and credentialing and provider EDI enrollment.

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3B. How can cross-agency collaboration be enhanced to reduce duplicative efforts in auditing, reporting, or compliance monitoring?

WEDI Comment:

CMS and ASTP/ONC

WEDI recommends CMS work with ASTP/ONC to address the following:

• Improve alignment between CMS and ASTP/ONC related to their visions, frameworks, roadmaps, and requirements for industry direction to establish an innovative, technology-enabled, health care ecosystem that will support effective and efficient patient care delivery.
• Enhance education for beneficiaries to enable them to be well-informed users of digital health technology to drive their care coordination, disease management, and wellness.

Interoperability

CMS and ASTP/ONC need to improve their collaboration on the direction of interoperability, including incentives and disincentives to drive industry implementation of standards, technology, and functionality to achieve the mutual goals.

One specific area of interoperability that needs more collaboration between CMS and ASTP/ONC is information blocking. A more cohesive approach is needed as the current infrastructure is siloed and has caused issues related to compliance, appeals, and general procedural clarity. Monitoring and reporting of information blocking activities and complaints would benefit from a centralized approach. Additional education for providers on the information blocking requirements and exceptions is also needed.

Compliance and Auditing

CMS should address duplicate requirements for compliance and auditing within the agency and with other government entities. For example, CMS and states should work to harmonize requirements for security compliance monitoring and auditing.

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3C. How can Medicare better align its requirements with best practices and industry standards without imposing additional regulatory requirements, particularly in areas such as telemedicine, transparency, digital health, and integrated care systems?

WEDI Comment:

Telehealth

Telehealth has successfully overcome barriers to health care access and delivery. WEDI recommends that CMS support efforts to expand Medicare beneficiaries’ access to telehealth services by focusing on eliminating burdens related to broadband infrastructure, affordable smart-enabled devices, and digital literacy skills for both providers and patients.

Additionally, expanding telehealth services will close gaps in access to care for beneficiaries living in rural communities without imposing additional regulatory requirements. WEDI recommends that telehealth waivers, set to expire on September 30, 2025, be made permanent.

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Topic 4: Additional Recommendations

4A. We welcome any other suggestions or recommendations for deregulating or reducing the administrative burden on healthcare providers and suppliers that participate in the Medicare program.

WEDI Comment:

Prior Authorization

The data exchange process for requesting and receiving prior authorization (PA) for health care services is burdensome for providers and payers. We appreciate the steps towards a less burdensome and more efficient process for PA for Medicare and other certain government payers through the “CMS Interoperability and Prior Authorization” (CMS-0057-F) Final Rule. To improve CMS-0057-F, we recommend that CMS publish Interoperability Standards and Prior Authorization for Drugs (CMS-0062) proposed rule, included in the Fall 2024 Unified Agenda. This rule would propose new requirements for CMS-0057-F impacted payers to streamline processes for the prior authorization of certain drugs.

WEDI also makes the following recommendations:

• Develop incentives for health plans not subject to CMS-0057-F to voluntarily implement its PA requirements and procedures.
• Finalize the HIPAA exception (currently under enforcement discretion) regarding use of the X12 Health Care Services Review Request and Response (278) transactions in the PA process when stakeholders conduct electronic PA with application program interfaces (APIs).
• Urge ASTP/ONC to finalize requirements that certified EHR vendors support PA APIs, as this will ensure that providers have access to this new technology.
• Allow health plans the flexibility and discretion to create incentive programs for the reduction or elimination of PA requirements.
• Educate Medicare beneficiaries on how to access their information via APIs and incentivize their use.

Other General Comments:

• Eliminate the remaining COVID-19 reporting requirements.
• Enhance technology, standards, and innovation by:
  • Employing digital health technology in a manner that brings care closer to the patient.
  • Focusing on the use of technology to improve patient care.
  • Identifying and recommending evidence-based clinical solutions.
  • Leveraging incentives to encourage voluntary adoption of standards and best practices.
  • Supporting integrated care models and advocating for removal of duplicative requirements for organizations already coordinating data sharing.