Game On - Two RFIs in Healthcare
Looking for System C Design and Outcomes from a System B Industry
I’m so thankful that we suffered through the mental hamster wheel of System A, B and C before everything got started with the new administration and new policies. Last week someone asked if I thought anything would happen and I said you know it’s been surpisingly quiet, but I still hold out hope. It springs eternal for me.
Then this week happened. It’s game on for healthcare from the new administration.
We wrote about the CMMI Make America Healthy Again 2025 strategy yesterday and then learned late last night and today that two important RFIs have dropped.
Everyone out here reading our endless words, it’s time we assemble and have a collective voice. By now, you know how to find us.
Before we jump into the RFIs, I want to lay this important bit of context. System B is not economically aligned to MAHA or the current administrations vision.
Healthcare is built to profit from disease
There is no incentive for people to be healthy
CMMI is focused on preventing disease in a population that already has disease - they are 65+
Food has to be fixed for anything to work
Incentives must be aligned with objectives
The good news? There are two RFIs (I’m sure more will follow) asking for what in essence is System C. I’ll say it again, we have an opportunity.
In the immortal words of “Eminen” - “This opportunity comes once in a lifetime…
The moment, you own it, you better never let it go…You only get one shot, do not miss your chance…”
(1) HHS RFI - Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again
Comments due by 11:59pm (ET) July 14, 2025.
To implement the President's Deregulatory Initiatives, including DOGE, and to better promote the health and well-being of the American people, HHS is planning the largest deregulatory effort in the history of the Department
HHS seeks input from all interested parties on how to dramatically deregulate across all areas the Department touches
HHS also welcomes other submissions explaining how regulations, guidance, paperwork requirements, and other regulatory obligations can be repealed.
As Secretary, I believe that an important component of Making America Healthy Again is making sure that providers and caretakers can focus on preventing and treating chronic diseases instead of having to do unnecessary or burdensome paperwork and otherwise comply with Administrative burdensome requirements with no clear health benefit. - RFK Jr
HHS welcomes submissions explaining how regulations, guidance, paperwork requirements, and other regulatory obligations can be repealed. The questions to be answered.
HHS is seeking input from a full range of stakeholders, including health care providers and suppliers; State, local, territorial, and Tribal governments; health and drug plans and payers; human services agencies; public health agencies; community- and faith-based organizations; long term care facilities; pharmacist and pharmacy associations; health and human services professional organizations; farmers and food producers; patient advocacy groups and organizations; people living with chronic disease and their family members; researchers; health technology organizations; and other businesses.
Describe how the recommendation would lead to cost savings, how much savings are anticipated, and the statutory authority that would permit HHS to act on the recommendation. Respondents should identify the specific regulation, guidance, or requirement at issue along with its administering HHS division. Where practical, please also include data, legal citations, quantitative estimates, and recommended actions. Economic data to demonstrate costs and savings are strongly encouraged, with an emphasis on the especially ambitious deregulatory ideas that may require a stronger evidentiary basis. omments containing references, studies, research, or other empirical data that are not widely published should include electronic links or copies of the referenced materials attached as an appendix.
Here are the questions
What HHS regulations and/or guidance meet one or more of the following seven criteria identified in (EO - Ensuring Lawful Governance and Implementing the President's “Department of Government Efficiency” Deregulatory Initiative)? Should they be modified or repealed? What would be the impact of this change, especially the costs and savings?
What regulations should we reconsider as we look to achieve some of the policy objectives outlined in EO - “Establishing the President's Make America Healthy Again Commission,” to focus on reversing chronic disease?
For more general deregulatory consideration under EO - “Unleashing Prosperity Through Deregulation”, are there additional HHS regulations and/or guidance that - many are listed but the two that stand-out…otherwise interfere with the public or private sector's ability to address chronic health conditions or otherwise promote the health and wellbeing of Americans? Impede access to or delivery of care or services.
What alternative approaches could be taken to achieve or accomplish the same goal with a lesser burden? For example, are there less burdensome approaches that are used by other entities such as State governments or private companies that could be adopted by HHS to achieve its goal with less burdensome requirements? What would be the impact on costs and savings?
Are there HHS regulations, guidance, or reporting requirements that are rooted in outdated technology? Can new technologies be leveraged to allow for rescinding or updating these policies? What are the cost implications?
Are there HHS regulations, guidance, or reporting requirements that are inconsistent with Executive Orders 14151, 14154, 14168, and 14213 or others issued by the President? Should they be modified or rescinded to make them consistent?
(2) CMS RFI - Improving Technology to Empower Medicare Beneficiaries
Comments due by 11:59pm (ET) June 16, 2025.
I have to be honest I read through this bad boy and it effectively reads to me like a combination of total deer in headlights and complete denial.
There is a lengthy explanation of 10 years worth of rules around health technology and interoperability - all of which are System B - solely focused on sickcare. It speaks to patient claims and encounter data, security, portability, all the buzzwords basically.
And then it’s like someone who dreams of a new world (galaxy far, far away perhaps?) wrote up a wish list.
…Evolving digital health products will gain greater functionality and potential for enhancing the healthcare experience, reducing costs, increasing access to care, enabling chronic disease prevention, and improving healthcare outcomes.
My favorite part - “Although the building blocks for a patient-centric digital health ecosystem are in place, the experience of most patients, caregivers, and providers is neither seamless nor simple.” Um ya think?
It goes on to say “To get access to their data, patients have to track which providers they have seen and set up separate accounts and credentials with each portal. Even for patients who are able to set this up, digital products for health management or care navigation that can leverage patient health records are still rare; appointment scheduling often still entails lengthy phone calls and provider intake still involves clipboards of multiple forms.”
You can’t make this up. I mean this is seriously the best we can do. I’d love to get Grok Unhinged’s take on this badboy.
Then it’s like the dream of a new day merges with reality and suggests that we could:
“build on the existing policy framework to drive large-scale adoption of health management and care navigation applications, reduce barriers to data access and exchange, realize the potential of recent innovations in healthcare that promote better health outcomes, and accelerate progress towards a patient-centric learning health system” - CMS
The RFI goes on to state - effective and responsible adoption of technology can empower patients to make better decisions for their health and well-being. This request for information (RFI) seeks input from the public regarding the market of digital health products for Medicare beneficiaries as well as the state of data interoperability and broader health technology infrastructure. Responses to this RFI may be used to inform CMS and ASTP/ONC efforts to lead infrastructure progress to cultivate this market, increasing beneficiary access to effective digital capabilities needed to make informed health decisions, and increasing data availability for all stakeholders contributing to health outcomes.
They want to know about:
Drive large-scale adoption of health management and care navigation applications, reduce barriers to data access and exchange, realize the potential of recent innovations in healthcare that promote better health outcomes, and accelerate progress towards a patient-centric learning health system
How we can help achieve the potential of digital health technology
Feedback on which elements of today's digital health ecosystem are working, which are working inconsistently and need improvement, and which are impeding rapid progress
Input for possible consideration in future rulemaking on policies to ease health data exchange and promote innovation in consumer digital health products
How HHS can encourage patient, caregiver, and provider engagement with digital health products
Value Based Care is mentioned - while significant progress has been made in health IT adoption, opportunities remain to better align technology requirements with the needs of providers participating in Alternative Payment Models (APMs) and other value-based care programs
Input on requirements for the use of certified electronic health record (EHR) technology (CEHRT), and how such requirements can enable value-based care and meet statutory requirements while meeting other program objectives, such as reducing provider burden, to better support value-based care adoption among providers, and subsequently improve patient choice and competition in the healthcare marketplace
And then the questions (I’ve omitted the sub-questions)
Patients and Caregivers
What health management or care navigation apps would help you understand and manage your (or your loved ones) health needs, as well as the actions you should take?
Do you have easy access to your own and all your loved ones’ health information in one location (for example, in a single patient portal or another software system)?
Are you aware of health management, care navigation, or personal health record apps that would be useful to Medicare beneficiaries and their caregivers?
What features are missing from apps you use or that you are aware of today?
What can CMS and its partners do to encourage patient and caregiver interest in these digital health products?
What features are most important to make digital health products accessible and easy to use for Medicare beneficiaries and caregivers, particularly those with limited prior experience using digital tools and services?
If CMS were to collect real-world data on digital health products’ impact on health outcomes and related costs once they are released into the market, what would be the best means of doing so?
Data Access and Integration
In your experience, what health data is readily available and valuable to patients or their caregivers or both?
Given that the Blue Button 2.0 API only includes basic patient demographic, Medicare coverage, and claims data (Part A, B, D), what additional CMS data sources do developers view as most valuable for inclusion in the API to enable more useful digital products for patients and caretakers?
How is the Trusted Exchange Framework and Common Agreement™ (TEFCA™) currently helping to advance patient access to health information in the real world?
How are health information exchanges (HIEs) currently helping to advance patient access to health information in the real world?
What are the most valuable operational health data use cases for patients and caregivers that, if addressed, would create more efficient care navigation or eliminate barriers to competition among providers or both?
Information Blocking and Digital Identity
How can CMS encourage patients and caregivers to submit information blocking complaints to ASTP/ONC’s Information Blocking Portal? What would be the impact? Would increasing reporting of complaints advance or negatively impact data exchange?
Regarding digital identity credentials (for example, CLEAR, Login.gov, ID.me, other NIST 800-63-3 IAL2/AAL2 credentialing service providers (CSP) - a whole slew of questions for this one
Providers
What can CMS and its partners do to encourage providers, including those in rural areas, to leverage approved (see description in PC-5) digital health products for their patients?
What are obstacles that prevent development, deployment, or effective utilization of the most useful and innovative applications for physician workflows, such as quality measurement reporting, clinical documentation, and billing tasks? How could these obstacles be mitigated?
How important is it for healthcare delivery and interoperability in urban and rural areas that all data in an EHR system be accessible for exchange, regardless of storage format (for example, scanned documents, faxed records, lab results, free text notes, structured data fields)?
What changes or improvements to standards or policies might be needed for patients’ third-party digital products to have access to administrative workflows, such as auto-populating intake forms, viewing provider information and schedules, and making and modifying an appointment?
Which of the following FHIR APIs and capabilities do you already support or utilize in your provider organization’s systems, directly or through an intermediary?
What strategies can CMS implement to support providers in making high-quality, timely, and comprehensive healthcare data available for interoperability in the digital product ecosystem? How can the burden of increasing data availability and sharing be mitigated for providers? Are there ways that workflows or metrics that providers are already motivated to optimize for that could be reused for, or combined with, efforts needed to support interoperability?
What are ways CMS or partners can help with simplifying clinical quality data responsibilities of providers?
How might CMS encourage providers to accept digital identity credentials (for example, CLEAR, ID.me, Login.gov) from patients and their partners instead of proprietary logins that need to be tracked for each provider relationship?
Regarding digital identity credentials (for example, CLEAR, Login.gov, ID.me, other NIST 800-63-3 IAL2/AAL2 CSPs): and then questions
How could members of trust communities (for example, QHINs, participants and sub-participants in TEFCA, which requires Identity Assurance Level 2 (IAL2) via Credential Service Providers (CSPs)) better support the goals of reduced provider and patient burden while also enhancing identity management and security?
Should ASTP/ONC consider removing or revising any of the information blocking exceptions or conditions within the exceptions (45 CFR part 171, subparts B through D) to further the access, exchange, and use of electronic health information (EHI) and to promote market competition?
For any category of healthcare provider (as defined in 42 U.S.C. 300jj(3)), without a current information blocking disincentive established by CMS, what would be the most effective disincentive for that category of provider?
Payers
What policy or technical limitations do you see in TEFCA? What changes would you suggest to address those limitations? To what degree do you expect these limitations to hinder participation in TEFCA?
How can CMS encourage payers to accelerate the implementation and utilization of APIs for patients, providers, and other payers, similar to the Blue Button 2.0 and Data at the Point of Care APIs released by CMS?
How can CMS encourage payers to accept digital identity credentials (for example, CLEAR, ID.me, Login.gov) from patients and their partners instead of proprietary logins?
What would be the value to payers of a nationwide provider directory that included FHIR end points and used digital identity credentials?
What are ways payers can help with simplifying clinical quality data responsibilities of providers?
How can CMS encourage payers to submit information blocking complaints to ASTP/ONC’s Information Blocking Portal? What would be the impact? Would it advance or negatively impact data exchange?
Technology Vendors, Data Providers, and Networks
This section is quite technical in the RFP and “is intended for all stakeholders to provide input on questions as they relate to use cases and workflows that involve technology vendors, data providers, and networks. While we certainly want technology vendors, data providers, and networks to answer questions in this section (and in other sections) from their point of view, we also invite all stakeholders to provide their viewpoints on the technology vendor, data provider, and network use cases as appropriate.”
Value-Based Care Organizations
What incentives could encourage APMs such as accountable care organizations (ACOs) or participants in Medicare Shared Savings Program (MSSP) to leverage digital health management and care navigation products more often and more effectively with their patients? What are the current obstacles preventing broader digital product adoption for patients in ACOs?
How can key themes and technologies such as artificial intelligence, population health analytics, risk stratification, care coordination, usability, quality measurement, and patient engagement be better integrated into APM requirements?
What are essential health IT capabilities for value-based care arrangements?
What are the essential data types needed for successful participation in valuebased care arrangements?
In your experience, how do current certification criteria and standards incorporated into the ONC Health IT Certification Program support value-based care delivery?
What specific health information technology capabilities that could benefit APMs are not currently addressed by existing certification criteria and standards that should be included under the ONC Health IT Certification Program?
How can technology requirements for APMs, established through CEHRT or other pathways, reduce complexity while preserving necessary flexibility?
How can other HHS policies supplement CEHRT requirements to better optimize the use of digital health products in APMs? As an example, requirements under the Conditions of Participation for hospitals (42 CFR 482.24(d)) require hospitals to transmit electronic patient event notifications to community providers. What barriers are in place preventing APM participants from receiving the same notifications?
What technology requirements should be different for APM organizations when comparing to non-APM organizations (for example, quality reporting, and interoperability)?
In the Calendar Year (CY) 2024 Physician Fee Schedule final rule (88 FR 79413), CMS established that CEHRT requirements for Advanced APMs beyond those in the “Base EHR” definition should be flexible based on what is applicable to the APM that year based on the area of clinical practice. What certification criteria should CMS identify under this flexibility for specific Advanced APMs, or for Advanced APMs in general? Are there specific flexibilities or alternatives to consider for smaller or resource-constrained (such as rural) providers in meeting CEHRT requirements without compromising quality of care or availability of performance data?
What specific interoperability challenges have you encountered in implementing value-based care programs?
What technology standardization would preserve program-specific flexibility while promoting innovation in APM technology implementation?
What improvements to existing criteria and standards would better support value-based care capabilities while reducing provider burden?
How could implementing digital identity credentials improve value-based care delivery and outcomes?
How could a nationwide provider directory of FHIR endpoints help improve access to patient data and understanding of claims data sources? What key data elements would be necessary in a nationwide FHIR endpoints directory to maximize its effectiveness?
Prioritize. Deputize. Act.