HHS RFI - It's Time Our Food Is Health Group "Speaks Up"
A collective reply to the "Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again" RFI
Most of the healthcare industry considers themselves “done” with replying to the new administration with their innovative ideas by way of the hundreds of individual responses they submitted for the Centers for Medicare and Medicaid (CMS) RFI “Improving Technology to Empower Medicare Beneficiaries” that was due on June 12th.
We on the other hand believe the “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again” RFI for which comments are due by 11:59pm (ET) July 14, 2025 is of equal importance.
This RFI is due to HHS, the parent org of CMS. We believe it is designed to inform the Make America Healthy Again (MAHA) strategy to make our children healthy again currently under development by the MAHA Commission and due next month. The last line of the MAHA Report released in late May that we wrote about here states, “We invite all of America, especially the private sector and academia, to be part of the solution.”
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
Why This Matters to Our Food-is-Health Community
Innovation often stalls when outdated clinical, payment or technology rules slow pilots, coverage, reimbursement or data sharing. The RFI is a rare chance to highlight how smarter regulation can advance affordable nutrition and the reversal of chronic disease by addressing the root cause.
As of the writing of this article, the public register states that 159 comments have been received. We’ve scanned through the 88 (as of the writing of this) available for public review and NONE have accomplished what one response that combines the voices of our subscribers could offer - the full spectrum of elements driving human health from soil to cell - collectively.
Of the 200-plus submissions cluster into five broad currents:
Modernizers – startups and trade associations want 1990s-era tech rules updated so they can use mainstream tools (e-signatures, cloud platforms).
Access fixers – patients and clinicians push to keep pandemic telehealth, raise drug-supply caps and clear scope-of-practice bottlenecks that block care in rural or low-income areas.
Work-force realists – providers describe payment rules (for example the 80 percent wage mandate in Home- and Community-Based Services) that raise costs without funding the gap.
Evidence-first reformers – researchers ask HHS to align coverage with evidence on low-vision aids, contingency-management incentives for addiction and food benefits for chronic disease.
Ideological watchdogs – some groups seek broad roll-backs of gender-identity or religious-funding language.
Sentiment skews constructive: roughly two-thirds propose targeted edits or pilots rather than wholesale repeal. Anger appears mainly in patient stories about access barriers (especially ADHD drug shortages and prior-auth delays). Few outright oppose deregulation; most argue how to balance safety with agility.
Some we’ve talked to view the outstanding RFI as too controversial to reply directly given it’s reference to DOGE and deregulation.
While that is understandable, we believe this is short-sided.
The FY2026 budget brief for HHS lays out in the first section that the current goal is REORGANIZING HHS TO MAXIMIZE EFFICIENCY starting with “Establishing the Administration for a Healthy America” using the following diagram.
Going on to state that
“America spends nearly one-third of the federal budget on healthcare, only to rank last in terms of health among developed nations. Americans are seeing declines in life expectancy and facing the highest rates of chronic disease in the world. HHS is committed to making Americans healthy again, making the American health system the best in the world, and putting patients first. To accomplish this, we need to embrace radical change.” - HHS FY2026 Budget in Brief
This RFI matters.
The RFI Itself
When we dig into the RFI itself we feel a sense of responsibility on behalf of this powerful group of Food Is Health / System C leaders when we read:
“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.”
Simply put, that is us.
The RFI states:
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. However, HHS cannot accomplish this feat alone.
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.
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.
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. Comments 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.
The most helpful submissions are those that HHS can publish in the Federal Register with minimal revision—whether as notices of proposed rulemaking (NPRMs), direct final rules (DFRs), or other notices—rescinding previous rulemakings or provisions in the Code of Federal Regulations.
In a clear and concise manner, please 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. Analyses that conform to OMB guidance to Federal agencies on the development of regulatory analysis, Circular A-4 (2003), and to the HHS Guidelines for Regulatory Impact Analysis (2016), are similarly encouraged. Comments 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 is the RFI itself (link).
There are two places to submit a response - via a form or for more comprehensive replies including attachments here.
A Call To Action For Our Readers
Normally we would close the article with a this but we have a lot of content that some may not find valuable, so we’ll cut to the chase.
Regulation shapes what Food Is Health can achieve within System B and System C. A few thoughtful paragraphs today can cut years off future programs that aren’t properly informed. Let HHS hear from you.
While we commend the respondents to date what is clear is that no ONE entity can address “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again” because it will take an unprecedented collaboration amongst industries and entities. And to our knowledge that doesn’t currently exist.
That is precisely why we created this Substack, to convene that unified force. We wanted a place where everyone involved in human health from soil to cell and all points in between could convene and build an ecosystem that is capable of reversing the chronic disease epidemic while preventing it in the future.
This RFI is a rare chance and our first to show the value of our exceptional collective wisdom and thinking.
How you can add your voice?
We want to make this easy for all of you. We will compile it, we will find the themes, we will build the story, we will submit on this group’s behalf, we will you credit or keep your comments anonymous (according to your preference)… all we need are your pain points.
This isn’t about asking for more, it’s about pointing out the friction that needs to be removed. Start by thinking of the regulatory hurdles and requirements holding you back from System C or from MAHA within System B (current state).
If each reader can give us just one reply to any of the following, we’d over 1,000 ideas across our collective industries. Imagine if everyone got one friend to also reply? We’d have 2,000 voices compared to 159 to date. I’d call that making a statement.
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?
Are there HHS regulations and/or guidance that otherwise interfere with the public or private sector's ability to address chronic health conditions or otherwise promote the health and wellbeing of Americans?
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 “Unleashing American Energy” or “Establishing the National Energy Dominance Council” Executive Orders? Should they be modified or rescinded to make them consistent?
Until we create a more formal response tool, use this button to respond.
Details of A Few Notable Responses
Some of you may want to read more about the responses we found. We pulled a handful from the 88 available to the public to read that were notable for varying reasons.
A Few Comments Related to Food
Burdock Group:
Cites the failure of the Pure Food and Drug Act of 1906 in response to Upton Sinclair book The Jungle, that ultimately seized flour produced by Lexington Mill and Elevator Company demanding safety per se
Suggests the FDA SHOULD survey ingredient consumption, educate the consumer about the difference between hazard and risk, Review GRAS and GRAS affirmed substances (21CFR 182 et sec), Food Master Files (FMF) and Notification, Formalize authentication of expert panelists for GRASes and for dietary supplement ingredients, continue to require FDA approval for “filing” for all those meeting the threshold for dietary supplement proof of safety of “reasonable expectation”
Suggests the FDA SHOULD NOT revoke the GRAS exemption for food ingredients, ostracize ingredients on the basis that they were derived from petroleum products, use European regulations as a model to be emulated
American Beverage Association:
Acidified Foods - the Food Safety Modernization Act (“FSMA”) provides FDA with the authority to ensure acidified foods are produced under a food safety plan in which all hazards that require a preventive control are adequately addressed. The pre-existing registration and filing requirements under the emergency permit control do not advance food safety, are burdensome, and should be removed
Protein Products - FDA should revoke the requirement at 21 CFR § 101.17 (d). This currently requires certain warning statements for foods that derive more than 50% of their calories from protein, based on practices more than a few decades old. Such a labeling requirement is no longer necessary and, in fact, is inconsistent with current dietary practices and guidelines.
A Few Comments Related to Health Insurance
National Federation of Independent Business
Correct to allow longer policy duration and more renewals, such as was once provided in the final rule "Short-Term, Limited Duration Insurance," 83 Fed. Reg. 38212 - suggest a rule to provide that an STLDI policy has an expiration date that is no more than 12 months (as opposed to 3 months under current rules) after the original effective date of the policy and, taking into account renewals or extensions, has a duration of no longer than 36 months in total (as opposed to 4 months in total under current rules)
Make it possible for small businesses, and especially those with fewer than 10 employees, to provide to employees or otherwise assist employees to obtain affordable, flexible, and predictable health benefits that they want and need, and make the funding and administration of employer-provided health benefits as easy as possible for small businesses. A rule that allows employees to have STLDI policies for longer will advance these objectives. STLDI need not comply with many federal mandates applicable to individual health insurance coverage that hike the cost to consumers of health insurance coverage. STLDI offers a choice of more affordable, flexible, and predictable health insurance coverage for small business employers to offer their employees or for those employees to obtain on their own.
A Few Comments Related to Healthcare
Radiology Business Management Association
We respectfully urge the Department of Health and Human Services (HHS) to direct the Centers for Medicare & Medicaid Services (CMS) to make permanent the policy allowing virtual direct supervision via real-time audio/video communication technology for contrasted imaging studies
Mayo Clinic
HHS Regulations and/or Guidance that are Confusing, Unnecessarily Complicated or Administratively Burdensome:
Transfer Protocols - Remove the staff training elements under 42 CFR 482.43(c), and do not require transfer protocols for unit-to-unit transfer (unit-to-unit transfer is typically accommodated through electronic health record electronic order processes), just facility-to-facility transfer. If CMS does not fully eliminate this upcoming requirement, the agency should at least delay implementation
Conditions of Participation: Emergency Services - Completely eliminate the new requirement under 42 CFR 482.55(c); at a minimum, eliminate the staff training element given standard scope of practice and competency training
Hospitals and Critical Access Hospitals: Condition of Participation: Infection Control, Respiratory Illness Reporting - Remove the requirements for routine respiratory illness reporting, retaining the public health emergency (PHE)-specific requirements in the event of another pandemic
Validation Surveys: Fully rewrite the requirements at 42 CFR 488.9 to finalize the DOVS process and discontinue the burdensome 60-day look back survey process.
CMS - Conditions of Participation Interpretive Guidance: Reduce reliance by state survey agencies, CMS and the accrediting organizations on using interpretive guidance in place of regulations
Condition of Participation for Nursing Services: Nursing Care Plans: Remove the nursing care plan requirement under 42 CFR 482.23 to better reflect current technology and EHR documentation, as well as integrated multidisciplinary approach to patient care
Condition of Participation: Governing Body: Update the governing body requirements to permit greater flexibility for organizations to function as a system, independent of the provider agreement specificity
CMS - E-signature Policies for Laboratory Tests; Requirements for Ink Signature for Test Orders: Require Medicare Advantage (MA) plans to modernize policies to recognize electronic signatures on laboratory test requisitions as evidence of a physician’s intent to order, as is permitted for pharmaceutical and imaging services
CMS Requirement for National Health Care Safety Network: : CMS should stop using the following NHSN elements/data in value-based program measurement and reimbursement frameworks
CAHPS survey requirement for measurement of patient experience: Change the OAS CAHPS survey logic back to unit-based surveying. Hospitals should have the opportunity to share data by CPT code to help unit management to make improvements
State Survey Agency Functions: Discontinue using the state survey agency process for complaint investigations in situations where an organization already has a deemed status accreditor
HHS Regulations and/or Guidance that Impose Requirements on the Wrong Individual or Group
Condition of Participation for Discharge Planning: Community Resources: Revise requirements under 42 CFR 482.43 to alleviate compliance burden on hospitals to serve as holding facilities in the absence of community resources to support patients
HHS Regulations and/or Guidance that are Conflicting
Physical Environment: Adopt the latest industry-standard 2021 Life Safety Code to ensure equivalency in federal and state code requirements. Additionally, CMS should work with ASHRAE to expand parameters for Operating Room locations.
HHS Regulations and/or Guidance that Impede Access to or Delivery of Care or Services
CMS - Reimbursement for Part D Medications in Inpatient Setting: Allow providers within integrated delivery models (where healthcare services are coordinated between providers and a pharmacy integrated with the hospital) to bill and receive payment for these costs directly through Part D instead of the inpatient prospective payment system.
CMS - Off-Label Exclusions from Part D Outpatient Drug Coverage 42 CFR 423.100 Part D Drug: : Off-label medications sold by a pharmacy should not be captured under this exclusion. We believe this interpretation of the requirement aligns with original congressional intent. The exclusion of off-label prescriptions from Medicare Part D coverage is in conflict with standard medical practice. CMS should change its regulation to allow coverage of off-label prescriptions under Part D for a medically accepted indication.
CMS: Multiple Physician Visits to Group Practice Providers (Same Specialty) Occurring on Same Day: Allow payment for all services when a patient receives multiple services from physicians in the group practice (same specialty) on the same day.
CMS - Emergency Medical Treatment and Active Labor Act (EMTALA) and Transfer of Patients: Provide flexibility that allows hospitals to transfer patients from an emergency department to another hospital within the same health system when hospitalization is necessary and the patient is stable for transfer
CMS - 42 CFR 410.78(b)(3)),42 CFR 410.78(b)(4) Telehealth - Patient access barrier; innovation barrier: Work with Congress on enacting a statutory change that would permanently eliminate this requirement.
Clarify that Medicare Advantage (MA) plans must comply with the Skilled Nursing Facility SNF Presumption of Coverage under 42 CFR 409.30: Issue public notice that MA plans must comply with the SNF Coverage Presumption under 42 CFR 409.30
CMS - 42 CFR 489.20: Provider Agreements and Supplier Approval, Essentials of Provider Agreements, Basic Commitments: Allow APPs to also satisfy a hospital's on-call obligations. With increasing physician shortages, this policy change would decrease the risk of physician burnout. The APP must be adequately trained and have a backup physician partner to give advice for patient care as needed.
CMS - Medical Documentation - Program Integrity Manual, Pub. No. 100-08 Ch. 3, Sec. 3.3.2.1, Documents on Which to Base a Determination: Streamline medical documentation requirements for prior authorization of clinical laboratory tests to reduce inefficiencies and administrative burdens for clinical laboratories and ordering providers.
CMS - Prior Authorization Policies - 42 C.F.R. § 422.122, Prior Authorization Requirements 42 C.F.R. § 414.510, the Laboratory Date of Service Definition: Remove “date of service” roadblocks to prior approval and payment for laboratory testing services.
CMS - National Correct Coding Initiative (NCCI) - Medicare Policy Manual Chapter X (Pathology/Laboratory Services, Molecular Pathology, Medically Unlikely Edits) + General Coding Policies: Strike language in the NCCI Medicare Policy Manual that results in conflicting coding guidance for providers and results in inappropriate denials of medically necessary services
CMS - 42 CFR §418.22(b)(3)(iii) Provides additional detail on the requirements for the certification of terminal illness needed for the hospice benefit. This language is a source of denials for hospice services as instruction on the placement of the physician signature is strictly interpreted by the Medicare Administrative Contractors (MACs) or in the audit space. Modify the existing regulation to only require that the hospice provider document that which is medically necessary to support the patient’s need for hospice services based on the patient’s palliation and terminal prognosis
CMS - 42 CFR 409.30: 3-Day Stay Requirement and Waiver: Medicare beneficiaries only have benefits for skilled nursing facility (SNF) care with a prior 3-day inpatient stay: Work with Congress to remove this statutory requirement.
CMS - 42 CFR 424.57(f) - CPAP Payment Prohibition: : Eliminate the entire regulation or at least revise the definition of "affiliate" to remove the ownership language
HHS Regulations and/or Guidance that Impede Efforts to Innovate
CMS - 42 CFR 482.41(c)(4): Physical Environment: : Current physical environment requirements do not permit flexibility in patient care setting scenarios: : Modify 42 CFR 482.41(c)(4) to permit greater flexibility in the physical environment to match acuity level.
CMS - Use of T Codes for Emerging Therapies: Work with FDA to increase resourcing in this area and survey stakeholders to understand the approval and reimbursement processes that will be needed to maintain parity with the speed of technology, software and their application in the clinical setting
CMS - Mandatory CMS Innovation Center Models: : Transition all current CMS Innovation Center mandatory models to voluntary and refrain from implementing any future mandatory models.
CMS - 42 CFR 410.20(b): Telemedicine Guidance: Consider solutions that promote enhanced access across state lines, including (1) establishing a standard that interprets place of care as the location of the provider as opposed to the patient for purposes of licensure requirements, and (2) create a federal exemption for duplicative state requirements for specialists. In addition, consider permanent recognition of therapists (PT, OT, PTA, OTA, SLP) as providers of telehealth, regardless of setting
CMS - 42 CFR 410.26: Services and Supplies Incident to a Physician's Professional Services: Conditions: Allow services provided “incident to” in a free-standing clinic setting to be rendered under “general” supervision where patient safety is ensured. The current supervision requirements differ in settings due to differing billing rules.
CMS - 42 CFR.410.27: Supervision Rules and Telehealth Regulations. Incident to for Therapeutic Services Provided in Hospital Outpatient Settings: : Improve clarity and consistency in the language and supervision requirements across settings. Additionally, provide for consistent telehealth coverage under the PFS and OPPS in particular for services that may be provided by auxiliary staff to a patient’s home when using real-time audio video technology. Such a policy change would ensure that patients have access to the same high-quality services regardless of the billable setting
CMS - 42 CFR 415.172(a)(2)(ii): Services Provided by Residents in Teaching Settings: Harmonize with the incident to standard (in 42 CFR 410.26) to permit to the same degree permitted for supervision of clinical staff.
HHS Regulations and/or Guidance that Otherwise Interfere with the Ability to Address Chronic Health Conditions or Otherwise Promote the Health and Wellbeing of Americans
CMS - Hospital-level Total Hip Arthroplasty/Total Knee Arthroplasty Patient Reported Outcome- Based Performance Measure (THA/TKA PRO-PM) THA/TKA Patient-Reported Outcomes Performance Measure (PRO-PM): : Reconsider mandatory use of the measure under current CMS quality programs and support voluntary adoption
CMS - Excessive Radiation Dose or Inadequate Image Quality for Diagnostic CT in Adults (CMS1206v2): Suspend mandatory reporting until further refinement.
CMS - Severe Sepsis and Septic Shock Management Bundle (SEP-1): : Redesign the measure for partial scoring and allow clinical exceptions.
CMS - Medicare Clinical Laboratory Fee Schedule (CLFS) - Sec. 216 of the Protecting Access to Medicare Act (PAMA): Take immediate steps to address underlying flaws with the CLFS payment system that would help create more stable and accurate payments.
CMS Provider Enrollment Rules (42 CFR 424.516) and CMS Manuals (100-04, Chapter 13, Sec 150): Permanently remove these requirements to help ensure providers’ privacy and keep them safe