CMS Halts Mandatory Vaccine Reporting; Agency Will Explore Informed Consent Tracking Options

Centers for Medicare and Medicaid Services (CMS) issued new guidance this week that removes mandatory reporting of vaccination status to the federal program, and the federal agency will “strongly discourage states from using immunization measures in payment arrangements.” The guidance letter also says the agency will “explore options” to gather data about whether parents and families are properly informed about vaccine choices, safety, and side effects.

“Government bureaucracies should never coerce doctors or families into accepting vaccines or penalize physicians for respecting patient choice,” HHS Secretary Robert F. Kennedy Jr. said. “That practice ends now. Under the Trump administration, HHS will protect informed consent, respect religious liberty, and uphold medical freedom.”

The guidance letter states the agency will explore ways to account for religious exemptions in vaccine uptake data. Secretary Kennedy stood up for the right of individuals in states with religious exemptions to exercise that right. He also initiated an investigation into a midwestern school that allegedly administered a vaccine without parental consent to a student with a religious exemption.

CMS clarified that as an agency, it does not tie Medicaid and CHIP payments to performance on immunization quality measures. Some states implemented incentive programs to increase COVID-19 vaccine uptake during the pandemic, including California, Maryland, and Michigan.

For example, Michigan offered $10 to $100 to providers for each eligible beneficiary vaccinated, depending on the overall vaccinated patient percentage for the clinic. If a clinic had over 70% of patients vaccinated, they received a $100 incentive for each vaccinated patient.

Estimates show that the typical primary care provider has an average of 2,500 to 3,000 patients. The median rate of Medicare and Medicaid patients in a physician’s practice is about 26%. That could equate to $65,000 for COVID-19 incentives for the typical primary care provider in Michigan during the pandemic. Some clinics that target Medicaid and Medicare recipients specifically may have as many as 89% of their patients enrolled in the programs. That could equate to more than $200,000 in incentives for that clinic.

These incentive structures have been criticized for providing financial payments to administer a pharmaceutical product rather than for unincentivized, individual-based decision-making between the doctor and patient. The incentives for other childhood vaccines are more indirect, as vaccination is used as one metric for providers to receive incentive payments.

Dr. Robert Malone, a current ACIP member, said he believes many people were coerced into getting the COVID-19 vaccine and did so without having proper informed consent. “I believe that a large fraction of the population accepted the vaccine under coercive conditions and were not provided full informed consent,” Malone said. “I suspect that [without coercion] a much smaller fraction of the population would have accepted multiple vaccine doses. Furthermore, if early treatment had been made available, public health outcomes would have been better.”

The CMS guidance letter implies the agency will figure out new ways to track whether providers are giving patients enough information about vaccine risks and benefits to be considered “informed consent.” In February, Secretary Kennedy halted a CDC flu vaccination marketing program called “Wild to Mild,” and said he would like future vaccine marketing campaigns to focus on informed consent.

A 2016 study found that only 60% of parents received the Vaccine Information Statement (VIS) before a vaccine was administered to their child, which is required by federal law. 46% of the parents who received the VIS completed reading the document before the vaccine was administered, which amounts to 27% of parents in the study.

The authors of a 2025 peer-reviewed analysis published in Human Vaccines and Immunotherapeutics wrote, “VISs, rather than being developed with patient autonomy in mind, were a response to excessive vaccine injury litigation and resulting vaccine supply shortages. VISs do not provide meaningful information disclosures, with its producer – the Centers for Disease Control and Prevention – itself admitting that VISs should not be mistaken for informed consent forms. In its content, the VIS is too complex in its readability, does not situate immunization in a public health context, and does not present all alternatives. VIS delivery is also inadequate, with limited time given for patients to digest vaccine information and no documentation required to ensure that VISs were presented at all.”

The authors note that despite the CDC noting that VIS forms are not informed consent disclosures, states have not implemented their own informed consent procedures that go above and beyond the VIS document. The authors also explain that the VIS is written at a tenth-grade level, while the average American is able to read at an eighth-grade level. Furthermore, they state that there is no punishment to providers for not providing the VIS disclosure to patients before administering a vaccine.

A 2021 review article about communicating with vaccine-hesitant parents notes that many health care providers feel “ill-equipped” to answer questions because they lack training in “evidence-based communication strategies.” The authors do not say that providers should have more information to help dispel the concerns or myths regarding vaccine safety. Instead, the authors say doctors should “pivot” to talking about the disease itself rather than addressing a “misperception” about the safety of vaccination. The authors implore health care providers to use motivational interviewing to “nudge” patients towards vaccine acceptance.

In addition to the updates to remove mandatory reporting on vaccination status and the intent to track informed consent procedures, HHS said it would utilize the vaccine data voluntarily collected to “maintain a longitudinal dataset while exploring alternative immunization measures.”

Following the December ACIP meeting in which the universal Hepatitis B birth dose recommendation was removed, President Donald Trump directed Secretary Kennedy to evaluate the childhood vaccination schedule in comparison to peer countries like Denmark and Japan. These countries have better pediatric health outcomes with significantly fewer vaccines than the United States, as reported by The HighWire.