https://www.regulations.gov/docket/FDA-2026-N-7874

Deadline Oct. 19.

Off hand, not having read the FDA discussion paper as yet, some questions for your consideration:

• Will I have access to my personal health information?
• Who else will have access, and will they be able to use it without my knowledge or against my wishes?
• Do I trust FDA regulations to protect me?
• When Big Data helps write the FDA regulations (as only they have the expertise to do), will they serve me or their own interests?
• Am I better off with start-ups being completely free to innovate in health AI, including potential ways to protect my health data?

MedTech Intelligence is an online journal & newsletter providing insight & expert opinions on regulatory compliance, QA, product development & market access.

https://medtechintelligence.com/feature_article/fda-seeks-public-feedback-to-inform-regulatory-approach-for-generative-ai-enabled-medical-devices/

FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

August 18, 2026

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.

The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics relevant to the regulation of GenAI-enabled medical devices.

“Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Today’s announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes.”

The Digital Health Center of Excellence (DHCoE), within the FDA’s Center for Devices and Radiological Health, is leading this discussion paper which supports the FDA’s Public Health Pillar on Innovation and Global Leadership. This strategic pillar includes key priorities to advance regulatory frameworks for AI and digital health technologies.

“Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies,” said FDA Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “By inviting input from the public, we are launching a transparent process to inform the development of an approach that safeguards patients and consumers, advances innovation, and serves as a potential model for regulators around the world.”

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.

“Generative AI-enabled medical devices are poised to reshape the health technology landscape, and the FDA has an important responsibility to provide thoughtful leadership for this new era,” said DHCoE Director Rick Abramson, M.D. “This discussion paper advances the frontiers of regulatory science and propels a critical conversation about how to enable beneficial innovation, protect public health, and preserve trust.”

The discussion paper begins by outlining a possible two-axis framework for risk assessment that might be used to inform regulatory expectations. It then discusses a potential approach to premarket evaluation built on the concept of competency assessment, inspired at a high level by how physicians are trained and evaluated, consisting of non-clinical device benchmarking and clinical confirmation to evaluate whether a GenAI-enabled medical device performs as intended before reaching patients. The paper also describes several potential approaches to risk-proportionate postmarket monitoring and discusses considerations around foundation models and agentic AI systems. For each of these areas, the FDA poses targeted questions to inform the development of a regulatory framework that is scientifically rigorous, prioritizes patient safety, and aligns with the novel capabilities of GenAI-enabled medical devices.

The FDA encourages feedback on the discussion paper from device manufacturers, clinicians, consumers, researchers, the public, and other interested parties, to be submitted under the docket FDA-2026-N-7874 on Regulations.gov by October 19, 2026.

The discussion paper supports the FDA’s efforts to advance health care by fostering the responsible innovation of safe, effective, and high-quality digital health technologies.

None of these ED admissions are paid for by the taxes collected on recreational marijuana, of course.  Your health insurance premiums and taxes pay for scromiting admissions.

The CDC’s National Syndromic Surveillance Program data were analyzed to examine trends in CHS-involved ED visits before and after implementation of a new, CHS-specific International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code on October 1, 2025.  This code allowed ED personnel to more accurately report cases of scromiting.

A huge increase in scromiting cases was found due to more accurate reporting.  Even so, the new numbers still likely underrepresent the full number of actual cases.

The Summary, Abstract, and Introduction to the CDC report, as well as its Implications for Public Health Practice at the end:

https://www.cdc.gov/mmwr/volumes/75/wr/mm7530a2.htm#contribAff

https://www.cdc.gov/mmwr/volumes/75/wr/pdfs/mm7530a2-H.pdf

Trends in Emergency Department Visits Involving Cannabis Hyperemesis Syndrome Identified Using a New Diagnosis Code — United States, January 2023–May 2026
August 6, 2026 / 75(30);391–396

By: Alana M. Vivolo-Kantor, PhD; Stephen Liu, PhD; Lauren J. Tanz, ScD; Christine L. Mattson, PhD; Josh Schier, MD
All from: Division of Overdose Prevention, National Center for Injury Prevention and Control, CDC

Summary

What is already known about this topic?

The prevalence of cannabis hyperemesis syndrome (CHS), a condition characterized by cyclical nausea and vomiting associated with frequent cannabis use, increased sharply in the United States during 2016–2022.

What is added by this report?

The proportion of all-cause emergency department visits that involved CHS were higher after implementation of a new International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code, suggesting improved recognition and previous underestimation of the public health impact of CHS. Higher proportions were observed among younger persons and females.

What are the implications for public health practice?

The new CHS-specific diagnosis code has improved CHS surveillance and estimation of public health impact. However, increased clinical recognition and education about risks of frequent cannabis use are still needed, particularly in younger populations.

Abstract

Cannabis hyperemesis syndrome (CHS) is a condition characterized by cyclical nausea and vomiting and is associated with frequent cannabis use. Data from CDC’s National Syndromic Surveillance Program were analyzed to examine trends in CHS-involved emergency department (ED) visits before and after implementation of a new, CHS-specific International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code on October 1, 2025. Monthly CHS-involved ED visits per 10,000 all-cause visits were assessed overall and by demographic characteristics. During January 2023–May 2026, a total of 199,565 ED visits involved CHS. During January 2023–September 2025, the proportion of ED visits that involved CHS remained mostly steady. In the first month after implementation of the new diagnostic code, the proportion of CHS-involved ED visits increased from 3.35 per 10,000 ED visits in September 2025 (preimplementation) to 11.26 per 10,000 ED visits in October 2025 (postimplementation). During the first 8 months after implementation of the new code (October 2025–May 2026), average monthly proportions of CHS-involved ED visits were 3.7 times as high as the monthly average during January 2023–September 2025. Higher proportions of CHS-involved ED visits were observed among persons aged 15–24 years and females, with more pronounced impacts among some demographic groups after code implementation. The abrupt, sustained increase might partly reflect improved recognition and coding of CHS rather than a true rise in incidence. These findings highlight a likely underestimated impact of CHS, suggesting the need to strengthen education about the risks associated with frequent cannabis use, expand ongoing surveillance efforts, and improve clinical recognition of CHS through continuing medical education and implementation of routine cannabis use assessment in ED settings.

Introduction

Cannabis hyperemesis syndrome (CHS) is a syndrome attributed to prolonged, frequent cannabis use, characterized by sudden episodes of severe nausea, vomiting, and abdominal pain (1). Reports of suspected CHS increased sharply during 2016–2022, with the largest increase occurring during the COVID-19 pandemic (2); the increase also coincided with widespread state-level cannabis legalization in the United States, although cannabis use remains illegal under federal law (3). Persons with CHS often seek medical care because symptoms can be severe and debilitating, with outcomes ranging from symptom resolution after cessation of cannabis use to, in rare cases, death (1).

Trends in cannabis use might be contributing to the increasing prevalence and recognition of CHS. The prevalence of past-month and daily or near daily cannabis use has been increasing, particularly among young adults and females (4). In addition, concentrations of tetrahydrocannabinol (THC), the primary psychoactive compound in cannabis, have increased in cannabis products over time (5). Higher THC concentration (>10%) is associated with continued and more frequent cannabis use among adolescents and young adults (6). Although THC concentration has not been directly linked to CHS, higher-potency products are associated with more frequent use, the primary risk factor for CHS (1,6).

CHS is likely underrecognized in both adolescent and adult populations. Clinicians might not routinely assess or document patients’ cannabis use; CHS can be misdiagnosed as other gastrointestinal conditions, such as cyclical vomiting syndrome (7). To improve clinical identification, a specific International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) discharge diagnosis code for CHS was introduced on October 1, 2025. This report examines trends in CHS-involved emergency department (ED) visits before and after implementation of this code.

<snip>

Implications for Public Health Practice

These findings highlight the need for increased awareness of CHS among clinicians and the public, but further educational efforts might be needed to prevent the cause of CHS: cannabis use. They also emphasize the importance of implementing evidence-based strategies to prevent cannabis use initiation and mitigate the consequences of cannabis use.

The observed higher proportions of CHS-involved ED visits after the new code was implemented in October 2025 potentially more accurately reflects true impact than previously observed proportions, underscoring the need for preparedness in emergency care settings, including appropriate clinical recognition and management of CHS. Clinicians can consider CHS in the differential diagnosis for patients with nausea, vomiting, and abdominal pain and can routinely assess cannabis use, including frequency, duration, product type, and route of use. Screening for substance use disorders and comorbid psychiatric conditions might also be warranted among patients reporting regular cannabis use (10).

Educational materials and communications campaigns should convey that younger age groups had high proportions of ED visits with CHS identification and that CHS might occur after shorter durations of cannabis use than was previously recognized (7,8). Expanded and tailored messaging might also be needed to raise awareness of CHS and other potential adverse health effects of cannabis use, particularly among younger populations. Communities can identify a wide range of effective substance use prevention and intervention strategies using CDC’s ENGAGE: Evidence-Based Strategies to Prevent Youth Substance Use resource for action.

Continued surveillance is important to better understand CHS epidemiology, including the potential role of high-potency THC and hemp-derived products and information on cannabis product characteristics (e.g., potency, type, or route of use) and to observe trends after code implementation to better assess prevalence. Monitoring trends across demographic groups and geographic areas can help identify populations at greatest risk and guide tailored prevention and intervention strategies.

The Teen Pregnancy Prevention Program (TPP) was created within the FY 2010 omnibus appropriations (P.L. 111-117) passed by Congress in 2009.  It was designed as a national, evidence-based grant program aimed at diverse organizations working to prevent teen pregnancy through effective educational programs.  TPP program grants must use evidence-based education models that have been shown to be effective in reducing teen pregnancy and related risk behaviors. A small share of TPP funds is available for research and demonstration grants that implement innovative strategies to prevent teenage pregnancy. The Further Consolidated Appropriations Act of 2020 (P.L. 116-94) provided the current $ 101 million for the program.

The Obama district court judge here is arrogating authority which he does not have under the Administrative Procedure Act (APA) to enforce his personal political opposition to abstinence based pregnancy programming.  Quelle surprise!  The APA does apply to federal grants, but claims related to grant terminations must be pursued in the U.S. Court of Federal Claims rather than federal district courts under the APA.  The sleazebag plaintiffs' lawyers involved here and the "judge" knew this, of course, but they wanted headlines and injunctions fast.  The USCFC APA claims process is quite complex and protracted for grant terminations:

https://michiganadvance.com/2026/08/20/repub/federal-judge-halts-proposed-hhs-changes-to-teen-pregnancy-prevention-program/

Federal judge halts proposed HHS changes to teen pregnancy prevention program
By Kelcie Moseley-Morris of Stateline - August 20, 2026

A federal judge in the District of Columbia issued an order Wednesday blocking U.S. Health and Human Services from implementing sweeping changes to grants under the Teen Pregnancy Prevention Program while a lawsuit proceeds, but dozens of existing grants that were canceled this summer will remain so for now, unless the administration chooses to reinstate the funds.

The agency canceled 53 out of 67 grants under the program at the end of June, affecting grantees in more than two dozen states, including Louisiana, New York, Oklahoma and Texas. Grantees were given no advance notice and were told their programs did not align with agency priorities — most were told their programs normalized or promoted sexual activity for minors. The grants were canceled two years before their expiration dates.

Following the cancellations, three affected grantees and sex education advocacy group SIECUS: Sex Ed for Social Change filed a lawsuit in the District of Columbia federal court district on July 14. U.S. District Judge Christopher Cooper, an appointee of former President Barack Obama, said the plaintiffs are likely to succeed in the case, warranting his decision to block the Trump administration’s actions.

But Cooper said it’s unclear whether he can order the restoration of nearly $70 million in canceled funds, and that other court cases need to be resolved before he can move forward with that kind of action.

Congress established the Teen Pregnancy Prevention Program in 2010 as a national, evidence-based grant program that would fund diverse programs working to prevent teen pregnancy using methods that have repeatedly shown to be effective. Grant recipients typically offer educational programs about preventing pregnancy or identifying healthy relationships, and provide referrals for community and healthcare resources as needed.

Since then, teen pregnancy rates have fallen about 72%, which researchers say is the biggest contributor to the overall drop in national birth rates.

To replace the canceled grants, HHS published two notices for new programs that focused less on preventing pregnancy and more on fertility tracking, “body literacy” goals and “reproductive goals counseling.”

“HHS is perfectly entitled to formulate its own views about how to stem teen pregnancy — or even whether it is worth preventing at all — and to pursue policy initiatives consistent with its viewpoint,” Cooper wrote in his ruling. “But it is not at liberty … to impose conditions on grant recipients that Congress did not intend or that are unreasonable or unexplained. The preliminary record suggests that HHS has done just that.”

Cooper said HHS could choose to reissue the grant funding opportunities under the previous guidelines, but it can’t move forward with the new ones while the lawsuit proceeds.

The judge also noted that in July 2025, HHS issued a notice telling grantees to revise their programs to align with current executive orders, including by deleting any references to health equity and inclusivity, and offered guidance about what it considered medically accurate and age appropriate content.

Three grantees sued over the notice, saying it was contrary to the statute guiding the program as established by Congress, and another D.C. judge agreed, vacating the guidance and blocking its implementation.

“As the saying goes, ‘When at first you don’t succeed, try, try again.’ HHS has taken this adage to heart,” Cooper wrote this week, citing the 2025 court case. “Unfazed by the adverse ruling, HHS issued new (grant funding notices) that repackaged the vacated policy changes and imposed additional grant parameters.”

The administration could appeal the decision in the coming weeks. Stateline has requested comment from HHS officials.

Soon to be ex-Senator from Louisiana Bill Cassidy, who believes he alone runs federal health policy, has “strong concerns” about Overton.  Expect a confirmation fight accompanied by much bowing and scraping:

https://thehill.com/homenews/administration/6039089-trump-heidi-overton-fda-nominee/

Trump taps White House adviser Heidi Overton to lead FDA
By Nathaniel Weixel - August 19, 2026

President Trump tapped Dr. Heidi Overton to be his new Food and Drug Administration (FDA) commissioner, he announced Wednesday on Truth Social.

Overton, a physician, is a top White House domestic policy adviser on health issues. If confirmed, she would take over an agency roiled by an exodus of top staff and viewed by many in the healthcare industry as less trustworthy and more politicized than it has been in any previous administration.

Her nomination comes about three months after the resignation of Marty Makary, Trump’s first FDA commissioner.

“Dr. Heidi has been a ROCKSTAR in my Administration,” Trump wrote. “We need her leadership at the FDA now to ensure that the U.S. remains the WORLD LEADER for Scientific Discovery and CURES.”

Overton is a major proponent of Health and Human Services Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” movement. Last week, she stood beside Trump when he announced an executive order to reduce and separate the childhood vaccine schedule.

At the time, she urged blue states to follow the administration’s “gold standard” recommendations, which were widely denounced by most pediatricians, major medical groups and public health experts.

“We are going to be working directly with states so that we’re not reliant on the court case to resolve,” Overton said, referring to an ongoing lawsuit over an earlier attempt to pare down the vaccination schedule.

She previously served as vice chair and chief policy officer of the America First Policy Institute (AFPI), a conservative think tank founded by Agriculture Secretary Brooke Rollins.

The FDA is facing enormous political pressure from top Trump administration officials, including the president himself.

The FDA has for decades been considered a nonpartisan, often wonky part of the administration. Commissioners have largely been medical or scientific bureaucrats with experience running large organizations.

But with the Trump administration’s embrace of top-down governing, the worry among the public health community is that the next commissioner will be even more susceptible to pressure.

Kennedy is pushing untested peptides with virtually no restrictions. Anti-abortion leaders and lawmakers want the agency to restrict access to the abortion pill mifepristone, and Trump pressed the agency to approve sales of flavored e-cigarettes for the first time.

Overton is an outspoken opponent of abortion. After the Supreme Court overturned Roe v. Wade, Overton celebrated the ruling, saying it “will allow Americans to reevaluate the value of the potential of every baby in the womb and choose life through a democratic process.”

She has also written articles for the AFPI that denounced abortion as “corrosive” to women and called for more controls over the prescribing of abortion pills.

Her nomination comes as the FDA is reviewing the safety of the abortion medication mifepristone.

Republicans and anti-abortion leaders are pressing the FDA to reverse a Biden-era rule that allows mifepristone to be mailed and dispensed through telehealth, not just in person. They also want the FDA to declare mifepristone as not safe and pull it from the market, despite it being used for decades with minimal negative side effects.

Chris Meekins, an analyst with Raymond James who served in the Health and Human Services Department during the first Trump administration, said Overton’s nomination would likely lead to more chaos at the agency at a time when officials seemingly wanted the opposite.

“Industry will view this pick as extremely troublesome and FDA career staff will continue to flee the agency,” Meekins wrote in a research note. “Any progress made since Makary’s departure is likely to be quickly reversed if she is confirmed.”

Overton has “seemingly no real experience running anything of consequence,” Meekins wrote.

Normally that could be mitigated by experienced staff helping to guide her, but any “’strong team’ who might be willing to initially fill roles, will likely quickly regret it,” Meekins added.

Overton will eventually receive a confirmation hearing in front of the Senate Health, Education, Labor and Pensions Committee.

Panel chairman Bill Cassidy (R-La.), a physician, publicly wavered but ultimately was a key “yes” vote on many of the Trump administration’s most controversial nominees, including Kennedy.

Cassidy, who lost his primary election to a Trump-backed opponent, wrote on social media Wednesday that he has “strong concerns” about Overton.

“Her lack of managerial experience does not prepare her well for leading a large organization that is already dealing with staffing and morale issues,” Cassidy said. “Additionally, Dr. Overton’s active role in last week’s nonsensical vaccine executive order calls into question her commitment to standing up for sound science and protecting children’s health. That alone is almost disqualifying.”

Overton has “seemingly no real experience running anything of consequence,” Meekins wrote.

Spoken as a man who would know.  Chris Meekins was a deputy assistant to the HHS Secretary with the public health emergencies remit in the lead up to COVID, a role which he flubbed badly.

https://www.realclearhealth.com/articles/2026/08/14/the_hhs_340b_pilot_steering_the_program_to_its_original_purpose_1200455.html

https://www.govinfo.gov/content/pkg/FR-2026-08-03/pdf/2026-15633.pdf

The HHS 340B Pilot: Steering the Program to Its Original Purpose
By Gary Andres - August 14, 2026

Program creep is a familiar Washington problem. Good ideas, originally intended to solve targeted challenges, expand beyond their original mission, often bringing higher costs and unintended consequences.

The federal 340B program is a case study in that phenomenon. Congress created 340B in 1992 to help hospitals and clinics serving low-income and uninsured patients stretch scarce resources by providing them deeply discounted drugs. Today, the program has grown far beyond those origins, creating opportunities for hospitals and other health-care providers to generate considerable revenue with little transparency about where the money goes.

To address this problem, the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), recently announced a 340B rebate model pilot program. It is a promising attempt to bring greater transparency and accountability to 340B — and begin steering the program back toward its original purpose. 340B was born of good intentions.

Drug manufacturers provide substantial discounts on outpatient medicines purchased by qualifying safety-net providers. Those providers can then receive reimbursement significantly higher than their discounted acquisition cost and retain the difference. The original idea was aimed at providers serving vulnerable populations to help them stretch limited resources and offer more care. Congress described the goal succinctly: to enable providers to “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”

That mission should remain the policy rudder to guide the program back on course.

Unfortunately, the program’s financial incentives have increasingly overshadowed that mission. Over the past two decades, 340B has expanded dramatically while federal oversight has struggled to keep pace. The program is now used for more than just assisting safety net patients; in some cases, it has been used to expand major health systems, hospitals, and clinics.

The numbers tell the story. According to HRSA data, purchases through 340B increased from $6.6 billion in 2010 to $100 billion in 2025. Participation has expanded as well. In addition to hospitals, the program encompasses federally qualified health centers, Ryan White HIV/AIDS clinics, family-planning clinics, tribal health programs and other eligible providers.

As HHS recently acknowledged, this expansion has introduced oversight challenges that were less pronounced when the program was smaller and less complicated, making it more difficult to verify compliance and ensure that the program’s benefits serve its intended mission and patient population.

Institutions respond to the incentives government creates, and hospitals and other 340B participants are no exception. When federal policy allows institutions to maximize the spread between a discounted acquisition price and reimbursement, they have a powerful incentive to organize their operations around that spread. The result can be additional revenue that isn’t necessarily tied directly to providing additional assistance to vulnerable patients.

In other words, a program designed as a safety-net risks becoming a revenue engine.

Critics have long pointed to gaps in transparency and oversight, particularly the difficulty of determining how institutions use the revenue generated through 340B. At the same time, HHS has encountered considerable legal constraints when it has attempted to impose new requirements administratively.

The status quo needs to change.

That is why HHS’ new 340B pilot comes at an important moment.

How would it work? Under the pilot, participating manufacturers of selected drugs could replace the traditional upfront 340B discount with a rebate. A covered entity would purchase an eligible drug at a higher upfront price and submit transaction-level information after dispensing it. Once the transaction is validated, the manufacturer would provide the rebate reflecting the 340B discount.

Importantly, the pilot is limited to drugs selected for Medicare price negotiation for the 2026 and 2027 applicability years. This makes the initiative a genuine test rather than a wholesale restructuring of 340B. If it succeeds operationally, policymakers will have evidence to consider whether the approach should play a larger role in the program’s future.

The pilot also includes safeguards intended to protect covered entities. Once a manufacturer receives a complete data submission, it must pay the rebate — or deny it with supporting documentation — within 10 calendar days. Manufacturers also face requirements governing data, reconciliation, technology costs and the grounds for denying rebates.

The significance of the pilot goes beyond the mechanics of when a discount is paid. A claims-based rebate system gives HHS greater visibility into individual 340B transactions, creates a stronger mechanism for identifying duplicate discounts, and produces data that can help regulators determine whether the program is operating as intended.

Hospitals and other covered entities will object that moving from an upfront discount to a rebate could disrupt cash flow and impose new administrative burdens. Those concerns deserve consideration. But they are also an argument for a limited pilot rather than for preserving the status quo indefinitely. HHS can measure those costs, identify operational problems, and adjust the model before contemplating broader changes.

The goal of 340B should not be to maximize revenue for participating institutions. It should be to stretch scarce resources, strengthen the healthcare safety net, and help the patients that safety net was originally developed to serve.

HHS’ pilot is a measured step toward restoring that principle. If it delivers greater transparency and accountability without undermining legitimate safety-net providers, it could offer something Washington rarely achieves: a way to reform a growing federal program by refocusing it on its original purpose.

Gary Andres is the Assistant Secretary for Legislation at the U.S. Department of Health and Human Services.

The Inflation Reduction Act (IRA) of 2022 was a United States federal law which claimed to reduce the federal government budget deficit and lower prescription drug prices.  The CBO claimed that the IRA's prescription drug language would reduce federal spending by $ 129 billion dollars during the 10 years ending in 2031. This CBO estimate was touted by IRA sponsors, who claimed it proved that the bill would reduce government spending and inflation.  We now know these assertions were bald faced political lies.

At the end of July, the then and current Director of the CBO, Phillip L. Swagel, sent a remedial letter to three powerful House Committee Chairmen:

Jodey Arrington
Committee on the Budget

Brett Guthrie
Committee on Energy and Commerce

Jason Smith
Committee on Ways and Means

The 29 July letter, "Developments in CBO’s Projections for Medicare Part D", retracts CBO's previous lies and deftly allows that Medicare Part D expenses to the government will amount to $ 700 billion, an $ 829 billion reversal from their 2022 lies.  A copy of this letter, in full, is attached as a .pdf file.

The money shot:

In September 2022, following the enactment in August, CBO projected that enacting those provisions would lead to combined deficit reductions of $129 billion over the 2022–2031 period.4 At the time, CBO estimated that by 2026, the reductions in direct spending stemming from the first two provisions would more than offset increases associated with enacting the third.

Since then, on the basis of new information, CBO has revised its projections. Evidence now indicates that the spending reductions attributable to drug price negotiation and inflation rebates have been smaller than CBO originally estimated. The costs of the Part D redesign have been significantly larger because of greater-than-anticipated increases in spending because of greater use of prescription drugs.

As a result, the agency now projects that those provisions will combine toincrease deficits over the 2022–2031 period.

An article on this turn of events:

https://www.cagw.org/cbo-confirms-ira-drug-negotiations-raised-costs-for-taxpayers/

CBO Confirms IRA Drug Negotiations Raised Costs for Taxpayers
By Eric Maus - August 5, 2026

Price controls in any industry do not work and inevitably lead to shortages and disrupted markets. Price controls on biopharmaceuticals are especially harmful because they raise costs, stifle research and development of new cures and treatments, and threaten America’s position as the global industry leader. As the Inflation Reduction Act (IRA) was being considered by Congress and then signed into law on August 16, 2022, Citizens Against Government Waste (CAGW) cited the costs and impact of the legislation, especially the damaging and dangerous price controls on drugs.

Despite conclusive evidence of the negative impact of price controls the Congressional Budget Office (CBO) nonetheless estimated that the drug pricing “negotiation” provisions for Medicare Part D in the IRA would save the government $129 billion from 2022-2031. On July 29, 2026, CBO sent a letter with a new estimate of their cost in response to a May 26, 2026, request by House Energy and Commerce Chairman Brett Guthrie (R-Fla.), House Ways and Means Committee Chairman Jason Smith (R-Mo.), and House Budget Committee Chairman Jodey Arrington (R-Texas) asking CBO to explore the budgetary effects of the IRA’s provisions that affect Medicare Part D. The letter confirmed that instead of saving $129 billion, the provisions have cost $700 billion. CBO also initially claimed that spending on drugs would be reduced from $3,200 monthly to $2,300 monthly. Instead, drugs now cost $3,500 per month.

In a press release announcing CBO’s findings, Chairman Smith said “Washington Democrats’ Inflation Expansions Act was yet another costly promise that failed to deliver lower prices for seniors. Democrats promised lower prescription drug prices, but the Congressional Budget Office is once again confirming that their policies instead increased costs for America’s seniors and taxpayers by an additional $700 billion while offering 50% fewer drug plans for them to choose from. Plain and simple, Democrats have made it harder for seniors to afford prescription drugs.”

Chairman Arrington noted that Democrats used CBO’s analysis and “sold the American people a false bill of goods.” Chairman Guthrie said that in addition to the incorrect savings estimates, the IRA has “led to increased costs for taxpayers and instability in the marketplace.”

Proponents of price controls and greater government control in healthcare claim that these policies will help patients by lowering costs, but the reality is quite different. An August 2022 University of Chicago issue brief found that price controls would increase healthcare spending by $50.8 billion over the next 20 years and result in 135 fewer drugs, negatively impacting the lives of 2.47 million patients.

The CBO mea culpa adds to the plethora of evidence that price controls on pharmaceuticals increase rather than lower costs for patients and limit access to vital medications. Lawmakers should protect American biopharmaceutical innovation and global leadership by fighting back against price controls on pharmaceuticals and every other industry.

https://www.whitehouse.gov/presidential-actions/2026/08/delivering-gold-standard-childhood-vaccine-recommendations-for-americans/

DELIVERING GOLD STANDARD CHILDHOOD VACCINE RECOMMENDATIONS FOR AMERICANS
Executive Orders
August 10, 2026

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:

Section 1. Purpose and Policy. Pursuant to the Presidential Memorandum of December 5, 2025 (Aligning United States Core Childhood Vaccine Recommendations with Best Practices from Peer, Developed Countries), the Department of Health and Human Services (HHS) completed a scientific assessment, which identified a set of consensus vaccines that are consistently recommended in all peer countries and found that the United States currently recommends more childhood vaccines than any peer nation, including more than twice as many vaccine doses as some European nations (scientific assessment). The scientific assessment also found that, instead of implementing vaccination mandates, most peer nations maintain high childhood vaccination rates through public trust and education. In the United States, by contrast, individual States set mandatory vaccination requirements that children must meet to attend school.

Executive Order 14407 of May 29, 2026 (Realigning United States Core Childhood Vaccine Recommendations With Best Practices From Peer, Developed Countries), committed the Federal Government to ensuring that Americans are receiving the best scientifically supported medical advice in the world, as well as to protecting religious liberty and parental authority. However, implementation of my Administration’s prior directives regarding childhood vaccines has been delayed due to litigation over the composition of the Advisory Committee on Immunization Practices and separate updates to the Federal vaccine schedule. Therefore, I am taking further action to reaffirm that it is the policy of the United States that the core childhood vaccine recommendations should be aligned with scientific evidence and best practices from peer, developed countries while preserving access to vaccines currently available to Americans. Further, it is the policy of my Administration that Federal programs and funding should support maximal parental choice over childhood vaccines, consistent with the Federal Government’s constitutional and statutory obligations and the fundamental principles of personal autonomy and informed consent.

Sec. 2. Recommendations for Childhood and Adolescent Vaccines. (a) Based on consultation with my advisors and review of available scientific evidence, it is hereby declared that the United States recognizes Gold Standard Childhood Vaccine Recommendations informed by the three distinct categories of childhood immunization recommendations identified in the scientific assessment, as specified below:

(i) immunizations recommended for all children: measles, mumps, rubella, diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type B, pneumococcal disease, human papillomavirus, and varicella;

(ii) immunizations recommended for certain high-risk groups or populations: respiratory syncytial virus monoclonal antibodies, hepatitis A, hepatitis B, meningococcal B, meningococcal ACWY, and dengue; and

(iii) immunizations based on shared clinical decision-making: hepatitis A, hepatitis B, rotavirus, meningococcal disease, influenza, and COVID-19.

(b) The Gold Standard Childhood Vaccine Recommendations also recognize that the combined measles, mumps, rubella (MMR) vaccine should be administered in three separate single-disease shots once such products are domestically available and that, to the maximum extent feasible, all childhood immunizations should be administered at separate medical visits.

(c) Each executive department and agency shall review the Gold Standard Childhood Vaccine Recommendations and take any appropriate steps to advance them, to the fullest extent allowable by law.

(d) States and territories are advised to review the Gold Standard Childhood Vaccine Recommendations and consider updating relevant laws and regulations that define the scope of immunization requirements for contexts such as school enrollment and attendance based on the scientific assessment and best practices from peer, developed countries.

(e) The United States will routinely reassess the Gold Standard Childhood Vaccine Recommendations according to the findings of the HHS Task Force on Safer Childhood Vaccines as specified in section 3 of this order.

Sec. 3. Improving Vaccine Research and Options for American Parents. The Secretary of HHS, through the HHS Task Force on Safer Childhood Vaccines, shall, within 90 days of the date of this order, present plans to the President through the Assistant to the President for Domestic Policy to, to the extent appropriate and consistent with applicable law:

(a) offer options to administer core childhood vaccines, starting with MMR, as single vaccines rather than combination products/doses, including by working with the private sector and other countries as appropriate, while guaranteeing continued availability of combination vaccines and those vaccines recommended for shared clinical decision-making;

(b) assess the ideal timing and sequencing of all core childhood vaccines and adjust the Federal childhood and adolescent vaccine schedule as appropriate based on gold‑standard science;

(c) develop additional alternative adjuvants to aluminum and conduct comparative safety and efficacy studies;

(d) ensure continuous evaluation of the risk/benefit profiles of all childhood vaccines based on United States and international data; and

(e) improve vaccine safety monitoring, transparency, and research.

Sec. 4. Maximizing Parental Choice over Childhood Vaccines. (a) The Attorney General shall take appropriate measures to further meritorious legal actions challenging State laws that conflict with States’ constitutional and Federal statutory obligations related to parental authority, religious freedom, disability accommodations, and equal protection under the law, including, to the extent applicable under Federal law, States’ obligations to provide religious and medical exemptions from childhood and adolescent immunization requirements.

(b) The Departments of Justice, Education, and HHS shall take appropriate action to ensure that their contractors and grantees, including States and localities, are compliant with their constitutional and Federal statutory obligations related to parental authority, religious freedom, disability accommodations, and equal protection under the law, including, to the extent applicable under Federal law, their obligations to provide religious and medical exemptions from childhood and adolescent immunization requirements.

Sec. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The costs for publication of this order shall be borne by the Department of Health and Human Services.

DONALD J. TRUMP

THE WHITE HOUSE,

August 10, 2026.

https://www.justice.gov/usao-cdca/pr/owner-santa-ana-based-fruits-and-vegetables-food-truck-indicted-charges-she-committed

Owner of Santa Ana-Based Fruits-and-Vegetables Food Truck Indicted on Charges She Committed Food Stamp Fraud
For Immediate Release: Thursday, August 6, 2026
By Ciaran McEvoy, Public Information Officer - U.S. Attorney's Office, Central District of California

LOS ANGELES – The owner of an Orange County-based fruits-and-vegetables food truck that law enforcement believes is the highest-redeeming vendor of Supplemental Nutrition Assistance Program (SNAP) benefits among nearby fruit-and-vegetable stores and large grocery stores, has been indicted on food stamp fraud charges, the Justice Department announced today.

Esmeralda Soriano, 48, a.k.a. “Esmeralda Aguilar” and “Esmeralda Silva,” of Santa Ana, is charged with two counts of illegal trafficking in SNAP benefits.

Soriano’s arraignment is scheduled for August 13 in United States District Court in downtown Los Angeles. She is free on $5,000 bond.

According to an indictment that a federal grand jury returned on Wednesday and other court documents, Soriano Produce is a low-volume fruits-and-vegetables mobile food truck operating in Santa Ana and, in March 2023, was authorized as an Electronic Benefits Transfer (EBT)-SNAP retailer. The business has one point-of-sale device that is used to complete EBT-SNAP transactions. Its lack of scanners coupled with consistent high-dollar transactions and rapid back-to-back transactions are indicators of possible fraud.

Law enforcement identified similar SNAP-authorized fruits-and-vegetables businesses between April 2025 and April 2026 that were within a 20-mile radius from Soriano Produce and determined that Soriano’s business was the largest SNAP-authorized redeemer with a total store volume of approximately $640,924, more than six times its nearest competitor, and an average purchase amount of $151.41.

Compared to large grocery stores within a five-mile radius during this same period, Soriano Produce was also the highest redeeming store of SNAP benefits, despite having more than 9,700 fewer transactions than the closest store. Further, Soriano Produce had the highest average transaction amount.

Law enforcement also discovered numerous excessively large EBT-SNAP transactions at Soriano Produce for a store of its type, with a dozen reaching or exceeding $1,000, far surpassing the California average of $17.72 for a fruits-and-vegetables store.

If convicted, Soriano would face a statutory maximum sentence of five years in federal prison for each count.

In a separate case, a federal grand jury on July 31 indicted Jesse Cervantes-Gomez, 30, a.k.a. “Ventura,” of Fontana, on three counts of illegal trafficking in SNAP benefits. Cervantes-Gomez was arrested on July 2 for exchanging SNAP benefits for cash at Escamex, a downtown Los Angeles-based store. His arraignment is scheduled for August 11 in U.S. District Court in downtown Los Angeles. He is free on $5,000 bond and, if convicted, would face a statutory maximum sentence of five years in federal prison for each count.

An indictment is merely an allegation. All defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.

Homeland Security Investigations and the United States Department of Agriculture Office of Inspector General are investigating these matters with assistance from the Orange County District Attorney’s Office.

Assistant United States Attorney Christopher Jones of the General Crimes Section is prosecuting this case.

On April 7, the Department of Justice announced the creation of the National Fraud Enforcement Division. The Fraud Division is laser-focused on investigating and prosecuting those who commit fraud against the American people. The Department’s work to combat fraud supports President Trump’s Task Force to Eliminate Fraud, a whole-of-government effort chaired by Vice President J.D. Vance to eliminate fraud, waste, and abuse within federal benefit programs.

HHS Secretary Robert F. Kennedy, Jr. decertified Network for Hope Wednesday after a long remedial period which did not improve their performance.  Hopefully the problems of Network for Hope are not common.  Decertification of an ODO is uncommon:

https://www.kentucky.com/news/politics-government/article316775483.html

Federal government decertifies Network for Hope, Kentucky’s organ donation group
By Hannah Pinski - August 5, 2026

U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. was in Lexington Wednesday to announce the federal government is ending its contract with Kentucky’s organ donation organization.

Network for Hope has come under scrutiny in recent years after a Health Resources and Services Administration investigation in 2025 found the organization ignored signs of life from several patients scheduled for procedures in the past four years.

Kennedy said extensive reviews by the Centers for Medicare & Medicaid Services and HRSA found persistent patient failures despite repeated oversight, warnings and corrective action plans.

“We found patients placed on the organ donation pathway who should have never been there,” Kennedy said. “We found cases where the donation process continued, despite signs that patients were not appropriate organ donors. We found repeated failures in clinical judgment, oversight and patient safety. And we found that these problems continued even after the organization promised to correct them.”

In addition to Kentucky, Network for Hope also serves parts of Indiana, Ohio and West Virginia.

Barry Massa, CEO of Network for Hope, said in a statement to the Herald-Leader that the organization will appeal Kennedy’s decision.

“NFH is compliant with all (organ procurement and transplantation network) policies and has implemented a first-of-its-kind ‘pause in procedure’ process to further strengthen patient safety,” Massa said. “This pause process is now Kentucky law, and NFH proudly worked hand-in-hand with legislators and regulators by providing input in the drafting both of the new law and its implementing regulations.

“Despite this, and despite NFH’s demonstrated dedication to improving organ and tissue donation outcomes across its service area, Secretary Kennedy has acted to decertify our (organ procurement organization) that serves seven million people across four states.”

Kennedy’s decision is part of an effort to address unsafe and unfair practices in the organ transplant system.

His department oversees the transplant system, which cut ties with a similar nonprofit in South Florida last year, according to reporting from The New York Times.

HRSA Administrator Tom Engels said care will still be offered to patients served by Network for Hope.

Between 2021 and 2024, HRSA examined 351 cases where organ donations were authorized but not completed at Network for Hope. Out of the 351 cases, 103 showed concerning features, including 73 patients with neurological signs incompatible with organ donation.

In the 2025 investigation, main findings included improperly taking over cases from doctors, pressuring families to proceed with donations for their loved ones and pushing hospital staff to proceed with organ donation procedures despite obvious signs of life.

One case that gained national attention involved Anthony Thomas “TJ” Hoover II. In October 2021, he was admitted to Baptist Health Hospital in Richmond after a drug overdose, and he was lined up for organ donation after being declared dead.

However, Donna Rhorer, Hoover’s sister, told NPR in 2024 she saw her brother open his eyes, and NPR also reported Hoover “thrashed around” while having his heart examined.

Plans for the procedure did not change until two doctors declined to operate on Hoover.

Hoover and Rhorer both attended the press conference. Kennedy told Hoover he’s grateful he’s still here, and is thankful for the physicians who had the courage to do the right thing.

“TJ’s story is a powerful reminder that every safeguard exists for a reason,” Kennedy said. “Most organ procurement organizations carry out this work with professionalism, compassion and deep respect for both donors and recipients. But Network for Hope repeatedly failed to meet those standards. It was a bad apple.”

Rhorer said her brother almost died that day and those responsible should be held accountable.

“When they finally stopped and acknowledged TJ was still alive, they sent him home with me and said: ‘Make him comfortable. He will not last,’” Rhorer said. “Well, it’s been five years, and he’s still here.”

Head Start is one of the few federal welfare programs which has not been plagued by corruption.  Its last significant overhaul was during 2007, on the cusp of the financial crisis:

https://www.politico.com/news/2026/08/06/trump-administration-unveils-major-head-start-overhaul-01026696

Trump administration unveils major Head Start overhaul
The Department of Health and Human Services' proposed rule would remove certain federal requirements governing the 61-year-old program.
By Mackenzie Wilkes - August 6, 2026

The Trump administration announced plans on Thursday to roll back regulations for Head Start, a popular federal program that provides free education, health and nutrition services to hundreds of thousands of low-income children.

Federal officials say the proposed rule from the Department of Health and Human Services would give the nation’s roughly 1,600 Head Start programs that receive federal funds more “flexibility” by scaling back a number of rules they must currently follow.

The program has traditionally received robust bipartisan support in Congress and across presidential administrations, but has been heavily criticized as ineffective by conservative and libertarian groups. Those criticisms have been rejected by Democrats, early childhood education advocates and even Trump administration officials such as HHS Secretary Robert F. Kennedy Jr.

“These are the poorest kids in our country,” Kennedy told reporters. “Ninety percent of them are at or below the poverty line. The program works.”

Head Start programs currently serve roughly 700,000 infants, toddlers and pregnant women across the nation.

The programs are governed by a set of regulations known as the Head Start Program Performance Standards, which detail how classrooms and programs are run, how curriculum is implemented and staff qualifications. But the proposal would shift federal standards around group sizes, classroom ratios, background checks and transportation to align with state early childhood education standards where programs are located.

“The federal standards set one-size-fits-all federal requirements for child-to-staff ratios, group sizes, and other operating standards,” Alex Adams, assistant secretary of the Administration for Children and Families at HHS, told reporters. “This would allow local providers to make local decisions in compliance with their state laws.”

Federal officials say the proposed rule — dubbed “Reducing Federal Burden for Head Start Programs” — would increase the number of slots to as many as 236,000 more children and would save $2.2 billion.

Kennedy said that when there were “draconian cuts to many of our agency programs” during the first year of the Trump administration, he “preserved Head Start from any cuts at that point.”

Head Start faced many headwinds and uncertainty last year. Programs experienced delays in grant payments and renewals, providers were temporarily locked out of their payment system during a federal spending freeze early in the year and the longest government shutdown in history last fall saw some programs temporarily close their doors.

And when a draft plan of HHS’ fiscal 2026 budget request reportedly proposed the elimination of the program, Kennedy testified before congressional lawmakers that the administration would “preserve” the program. Congress approved roughly $12.4 billion for the 61-year-old program for the current fiscal year and the White House’s budget request calls for flat funding for fiscal 2027.

Adams said the proposal “preserves all statutory requirements” dictated by the Head Start Act, the federal law authorizing the program, which Congress last updated in 2007.

The Heritage Foundation has long called for the elimination of Head Start, but the conservative group published a report last month saying the program should be deregulated in many of the ways the proposed rule suggests while “officials work to end the program.”

When asked if Head Start funding or programming is going to be cut, Adam’s said the president’s budget requests level funding for Head Start.

Congressional Democrats are already panning the proposed rule amid reports that the administration planned to deregulate the program.

“After trying and failing to defund it altogether, Trump is putting the program to the torch by rolling back federal standards that ensure Head Start be high quality,” Senate Minority Leader Chuck Schumer said in remarks on the Senate floor earlier this week.

And Rep. Rosa DeLauro (D-Conn.), the top Democrat on the House Appropriations Committee who has long been supportive of Head Start, said removing regulations could increase class sizes and lead to fewer services.

"f this administration later points to struggling students as proof Head Start does not work, we should all understand what this is – a self-inflicted wound used to justify another round of cuts,” DeLauro said in a statement Wednesday.

Adams stressed that the proposed rule would make it optional for Head Start programs to deviate from current requirements.

“The opportunity for these programs to make a different decision does not necessarily mean they must make a different decision,” he said.

Adams also said the proposed rule would cap administrative spending from 15 percent to 5 percent and set new nutrition and physical activity requirements, including aligning meals with the Dietary Guidelines for Americans.

The proposed rule is expected to publish in the Federal Register on Friday and have a 60-day comment period, according to officials.