The U.S. Department of Homeland Security (DHS) issued a final rule applicable to noncitizens who receive or wish to apply for benefits provided by the U.S. Department of Health and Human Services (HHS) and States that support low-income families and adults. The rule, which details how DHS will interpret the “public charge” ground of inadmissibility, will help ensure that noncitizens can access health-related benefits and other supplemental government services to which they are entitled by law, without triggering harmful immigration consequences. By codifying in regulation the “totality of the circumstances” approach that is authorized by statute and which has long been utilized by DHS, the rule makes it clear that individual factors, such as a person’s disability or use of benefits alone will not lead to a public charge determination.

The final rule applies to noncitizens requesting admission to the U.S. or applying for lawful permanent residence (a “green card”) from within the U.S. When assessing whether a noncitizen is “likely to become primarily dependent on the government for subsistence,” DHS will not penalize individuals who choose to access the vast majority of health-related benefits and other supplemental government services available to them, including most Medicaid benefits (except for long-term institutionalization – such as residing in nursing home – at government expense) and the Children’s Health Insurance Program (CHIP). DHS will also not consider non-cash benefits provided by other government agencies including food and nutrition assistance such as the Supplemental Nutrition Assistance Program (SNAP); disaster assistance received under the Stafford Act; pandemic assistance; benefits received via a tax credit or deduction; and government pensions or other earned benefits. Receipt of cash-based benefits, such as Supplemental Security Income (SSI), Temporary Assistance for Needy Families (TANF), and other similar programs, will not automatically exclude an individual from admission or green card eligibility, and will instead be considered in a “totality of the circumstances” analysis.

“People who qualify for Medicaid, CHIP, and other health programs should receive the care they need without fear of jeopardizing their immigration status,” said HHS Secretary Xavier Becerra. “As we have experienced with COVID, it’s in the interest of all Americans when we utilize the health care and other services at our disposal to improve public health for everyone.”

“This final rule reinforces a core principle of the Biden-Harris Administration: that healthcare is a right, not a privilege, and no one should be deterred from accessing the care they need out of fear,” said CMS Administrator Chiquita Brooks-LaSure. “Today’s final rule is an important step toward achieving this goal for many Medicaid and CHIP enrollees and their families, and CMS will continue to do everything in our authority to make sure people have access to programs that keep them safe and healthy.”

“Federal civil rights laws require that all people be afforded fair and just decisions when applying for health benefits and other supplemental government services, free of bias, stigma, and discrimination,” said Office for Civil Rights Acting Director Melanie Fontes Rainer. “Today’s rule sets up safeguards to help ensure that people with disabilities and older adults who are not U.S. citizens can access health care without fear.  OCR will continue our robust enforcement of civil rights laws to ensure the rights of historically marginalized groups are upheld and defended.”

“People with disabilities and older adults who are not U.S. citizens no longer have to fear that using services that can help them maintain their health, live independently and contribute to their communities will cost them legal residency in our country,” said Alison Barkoff, Acting Administrator of the Administration for Community Living. “The rule explicitly rejects stereotypes that people with disabilities are more likely to become a public charge and is in keeping with the civil rights protections that are the bedrock of American values.”

This final rule is the product of action first taken by the Biden-Harris Administration in 2021 to reverse the previous administration’s 2019 public charge rule, which had the harmful effect of discouraging many immigrants from seeking benefits, such as CHIP and other government services for which they, their children, or their families were eligible, out of fear of jeopardizing their immigration status. This chilling effect extended even to those categories of noncitizens who, by law, are exempt from the public charge ground of inadmissibility, including refugees, asylees, noncitizens applying for or re-registering for temporary protected status (TPS), special immigrant juveniles, T (trafficking victims) and U (crime victims) nonimmigrants, and self-petitioners under the Violence Against Women Act (VAWA). With the publication of today’s final rule, the Biden-Harris Administration is continuing its efforts to reverse these harmful effects and ensure that these programs remain accessible for eligible individuals and families in need.

The final rule does not expand eligibility for Medicaid, CHIP, or other benefits to more people but clarifies DHS policy regarding recipients.

The final rule will be effective on December 23, 2022.

It’s been a rough couple of years for the Centers for Disease Control and Prevention. Facing a barrage of criticism for repeatedly mishandling its response to the covid-19 pandemic and more recently monkeypox, the agency has acknowledged it failed and needs to change.

CDC Director Dr. Rochelle Walensky has tapped Mary Wakefield — an Obama administration veteran and nurse — to helm a major revamp of the sprawling agency and its multibillion-dollar budget. Making the changes will require winning over wary career CDC scientists, combative members of Congress, and a general public that in many cases has stopped looking to the agency for guidance.

“If she can’t fix it, she’ll say, ‘It’s not fixable, here’s why, and here’s what needs to be done next,’” said Eileen Sullivan-Marx, dean of the New York University Rory Meyers College of Nursing, who has known Wakefield professionally for decades.

Other former colleagues said Wakefield’s experience as a nurse, congressional staffer, policy wonk, and administrator give her the perspective and leadership tools to rise to the occasion, even as they acknowledged the magnitude of the job ahead.

“She has high standards, and she’ll expect people to perform,” said Brad Gibbens, a former employee and the acting director of the Center for Rural Health at the University of North Dakota School of Medicine and Health Sciences. “She’s very fair, but you need to know what you’re doing.”

Wakefield will have to navigate rough waters in the wake of a series of missteps by the agency. The CDC botched the covid testing rollout early in the pandemic, issued confusing guidance on prevention measures such as masking and quarantining, and has been slow to release scientific findings on the fast-moving coronavirus.

Walensky has stressed that, as part of the reset, she wants the CDC to give Americans clear, accurate, and timely guidance on community health threats.

“I am confident that the appointment of Mary Wakefield will be instrumental in accomplishing our goals to modernize and optimize CDC,” Walensky said in a written statement. “It is clear that Mary is an action-oriented leader who can lead effective change.”

Following an internal audit, Walensky announced plans to restructure how the agency communicates with the public, to eliminate bureaucratic redundancies, and to help the CDC better interact with other parts of the federal government.

Wakefield’s first day on the job was in mid-August. She declined to speak to KHN for this article, but those who know her painted a rich picture of her management philosophy and style.

NYU’s Sullivan-Marx said Wakefield’s experience as a nurse makes her well suited to solve the complex set of problems facing the CDC, which she compared to a patient in need of stabilization.

“When you look at someone in a bed in intensive care, all you see are beeps and lines and monitors going off — people moving in and out like a train station,” said Sullivan-Marx. “The nurse is central to that for the patient, pulling all of that together.”

Sullivan-Marx also said Wakefield’s perspective as a front-line health care worker could help the CDC better understand how clinicians will receive and interpret its guidelines and recommendations.

For most of the Obama administration, Wakefield led the Health Resources and Services Administration. HRSA, a division of the Department of Health and Human Services, is responsible for a wide portfolio of programs — those that serve people living with HIV, provide compensation for people injured by vaccination, and document disciplinary action against health care providers.

Former HHS Secretary Kathleen Sebelius called Wakefield a “change agent” who was able to win the trust of HRSA staff members, many of whom are full-time employees, not political appointees.

“Folks understood that they were there before she came in and they’d be there after she left,” Sebelius said. “They had to be convinced that she was a good leader and they were going to follow her. That’s pretty significant, that she did so well in that agency.”

(Sebelius is a member of KFF’s Board of Trustees. KHN is KFF’s editorially independent newsroom.)

Sebelius said such experience could be helpful to Wakefield at the CDC, which employs just over 12,000 people, some of whom could be skeptical of changes. Covid was a serious stress test for the CDC, leaving some staffers wondering if it had lost its way.

Sebelius also noted as a plus Wakefield’s experience working with the CDC as acting deputy secretary of HHS. She was nominated to be deputy secretary but never confirmed because of political squabbles over abortion.

Details about changes coming at the CDC are still trickling out, though top brass have said they’ll need the support of Congress to implement them.

Sheila Burke, head of public policy at the law firm Baker Donelson, got to know Wakefield while working in Congress. She said Wakefield’s experience on Capitol Hill will come in handy when dealing with lawmakers who sit on committees that oversee the CDC.

“She’ll be keenly aware of the role of the members who care deeply about these issues,” Burke said.

Top health officials have had a hard time justifying the federal government’s pandemic response to certain members of Congress. Walensky and Dr. Anthony Fauci, the Biden administration’s lead medical adviser, who will soon step down, faced intense questioning from legislators on several occasions.

“I think she’s uniquely positioned to understand how you navigate that relationship,” Burke said of Wakefield.

Multiple former employees pointed to what Gibbens, from the University of North Dakota, characterized as Wakefield’s “infatigable amount of energy.” He said it wasn’t uncommon for him to arrive at work to phone messages she’d left him at 4:30 in the morning.

He described Wakefield as someone who knows “when somebody is trying to play her.” But he also said she doesn’t take herself too seriously. He recalled a kitschy animatronic singing fish on her office wall, a nod to her love of fishing. And the time she declined to fly on Air Force Two from Washington, D.C., to North Dakota, choosing to take a commercial flight “like a regular person.”

“She said, ‘You gotta be really careful with that stuff. You don’t want to get used to that,’” Gibbens recalled.

The work ahead for Wakefield could be a stress test of her belief in the human value of public policy. Walensky has said the changes she hopes to implement at the CDC won’t happen overnight, and it’s likely they won’t be easy.

Much like the CDC in the current moment, in 2005 Wakefield found herself at a possible turning point. That year, Wakefield’s brother and two of his children were killed in a car accident that seriously injured her sister-in-law and young nephew.

“Health policy as a focal area of my work before, now felt of very little consequence,” Wakefield wrote at the time in the Journal of Forensic Nursing.

Then she received word that her former boss, Sen. Kent Conrad (D-N.D.), had joined with others to introduce the Wakefield Act, a bill aimed at improving emergency medical care for kids. Even though it didn’t pass, it reminded Wakefield that pulling the levers of government can have real-life consequences.

“They acknowledged my family’s loss and put their support behind legislation that can affect the lives of children of other families who may have a chance at survival,” Wakefield wrote. “Public policy is important — isn’t it?”

Proposed rule would reduce red tape and streamline administrative processes to help children, older adults, people with disabilities, and others from underserved communities connect to health care coverage through Medicaid and CHIP 

The Biden-Harris Administration proposed a new rule to overhaul the enrollment processes for Medicaid, the Children’s Health Insurance Program (CHIP), and Basic Health Programs (BHPs), and eliminate arbitrary coverage caps for children in CHIP. In a Notice of Proposed Rule Making (NPRM), the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is working to reduce red tape and simplify application and verification processes to make it easier for children, older adults, and people with lower incomes with Medicaid and CHIP coverage to enroll in and retain vital health insurance. This proposed rule follows President Biden’s executive orders in April 2022 and January 2021 directing federal agencies to take action to expand affordable, quality health coverage, including by strengthening Medicaid and the Affordable Care Act.

Under the Biden-Harris Administration, thanks to the American Rescue Plan and other Administration efforts, more Americans than ever before have health insurance coverage. Today’s proposed rule will build on these efforts and support President Biden’s calls to strengthen Medicaid and access to affordable, high-quality health coverage.

“Medicaid and CHIP provide essential health care to millions of families across the country, and we are making it easier to enroll children and others in health insurance and to maintain coverage,” said HHS Secretary Xavier Becerra. “With these steps, we’re delivering on our promise to make high-quality health care more accessible and affordable for all Americans.”

“CMS is acting today to protect and strengthen health care coverage for the more than 88 million people enrolled in Medicaid, CHIP, and the Basic Health Program,” CMS Administrator Chiquita Brooks-LaSure said. “This proposed rule will ensure that these individuals and families, often from underserved communities, can access the health care and coverage to which they are entitled – a foundational principle of health equity. In addition, this proposed rule will help more people pay their Medicare premiums by making it easier for them to enroll in the Medicare Savings Programs.”

This rule, if finalized, would standardize commonsense eligibility and enrollment policies, such as limiting renewals to once every 12 months, allowing applicants 30 days to respond to information requests, requiring prepopulated renewal forms, and establishing clear, consistent renewal processes across states.

Medicaid and CHIP are critical sources of health care insurance for families across the country. Medicaid is the single largest health coverage program in the U.S., covering nearly one in four Americans and providing robust benefits with little to no out of pocket costs. Together, Medicaid and CHIP provide 51% of our nation’s children and youth – more than 40 million children – access to quality, affordable health care. However, enrollment in these programs can be jeopardized because of cumbersome application or renewal processes and lack of uniformity in states across the country. This NPRM takes aim at those concerns, and includes a suite of proposed options to provide easier access to and retention in health care coverage.

In a major transformation to the programs and a historic win for American families, the Biden-Harris Administration is proposing to end lifetime benefit limits in CHIP and allow children to enroll in coverage right away by eliminating pre-enrollment waiting periods, consistent with nearly all other health coverage. The proposed rule would also permit states to transfer children’s eligibility directly from Medicaid to CHIP when a family’s income rises, preventing unnecessary redetermination processes from causing lapses in coverage.

The NPRM proposes simplifications that would increase enrollment and retention for people age 65 and older, as well as those who have blindness or a disability. The proposed rule, if finalized, would streamline the application process for these programs by removing unnecessary administrative hurdles for people who do not have – but are eligible for – Medicaid, CHIP, or BHP coverage. These individuals are often eligible for Medicaid, but are not yet enrolled or have trouble staying enrolled because of systemic barriers, potentially missing life-saving coverage and care because of burdensome processes.

The proposed rule also includes policies that would improve access to programs that help make health coverage more affordable for older adults and individuals with disabilities. It offers ways to simplify enrollment for Medicare Savings Programs, which permit Medicaid to pay Medicare premiums or cost sharing for Medicare beneficiaries with lower incomes. The proposed rule would also allow for automatic enrollment in Medicare Savings Programs for certain individuals receiving the Social Security Administration’s Supplemental Security Income – a key goal for streamlining connections to care for those who need them most.

A recent study estimated that only about half of eligible low-income individuals enrolled in Medicare were also enrolled in Medicare Savings Programs. This proposed rule would automatically consider older adults for Medicare Savings Programs enrollment when they apply for low-income subsidies to help pay for Part D Medicare coverage, reducing the burdens of both time and expense by eliminating the need to complete multiple applications.

Lastly, proper documentation is critical to enabling appropriate oversight, identifying errors in state policies and operations, and reducing inconsistent and outdated practices across states, which contribute to improper payments. This proposed rule would update and standardize recordkeeping requirements for states, which would help to address deficiencies in outdated state recordkeeping systems and improve program integrity.

For more information on the NPRM, consult the fact sheet available at https://www.cms.gov/newsroom/fact-sheets/streamlining-eligibility-enrollment-notice-propose-rulemaking-nprm.

To review or comment on the NPRM during its 60-day public comment period, visit the Federal Register.

Suzanne BeHanna initially turned down an experimental but potentially lifesaving cancer treatment.

Three years ago, the newlywed, then 62, was sick with stage 4 lymphoma, sick from two failed rounds of chemotherapy, and sick of living in a trailer park near the University of Texas MD Anderson Cancer Center in Houston. It was fall 2019, and treatment had forced her to migrate 750 miles east from rural New Mexico, where she’d settled only months before her diagnosis.

Chimeric antigen receptor T-cell therapy might have been appealing to BeHanna if it were available closer to her home. But it is offered only at major transplant hospitals.

BeHanna had been living in Houston for six months, suffering through chemotherapy that made her feel awful and didn’t stop her cancer. She wanted to go home to die, but her husband wanted her to give CAR T-cell therapy a chance if her doctor would approve it.

The therapy uses a patient’s T cells, a key part of the immune system, to fight cancer. Dr. Michel Sadelain, an immunologist at the Memorial Sloan Kettering Cancer Center in New York and a pioneer of the therapy, describes it as “a living drug — a T cell which has been weaponized against cancer.”

The treatment uses a process called apheresis to extract T cells from the patient and then genetically modifies the cells to add a receptor, the chimeric antigen, which binds with the cancer cells.

Making CAR T cells takes about 10 days, but because only three companies — Bristol Myers Squibb, Gilead Sciences, and Novartis — have FDA approval to produce them commercially, receiving the cells back for infusion can take up to a month. Once in the patient’s bloodstream, the CAR T cells multiply, recognize cancer cells, and kill them. If the therapy works, the patient’s cancer is usually in remission within a month.

For about 10 years, oncologists have used CAR T-cell therapy in clinical trials for patients with blood cancers — including BeHanna, who has diffuse large B-cell lymphoma, and others with lymphoblastic leukemia and multiple myeloma. But until recently, it was FDA-approved only for those who had already had two unsuccessful rounds of more conventional treatment, like chemotherapy. For some types of blood cancer, the therapy leads to remission in more than half of patients. In April, for the first time, the FDA approved CAR T-cell therapy for lymphoma patients whose cancer recurred within 12 months after only one round of more conventional treatment.

That more people will be eligible for CAR T-cell therapy seems like good news, but Dr. Jason Westin, an oncologist at MD Anderson, isn’t immediately optimistic. Westin, chair of the American Society of Clinical Oncology’s government relations committee, is concerned that as more patients become eligible, the cost — $375,000 to $475,000 — will strain the ability of insurers to support it.

Read more.

After acknowledging that CDC’s Covid-19 response “did not reliably meet expectations,” CDC Director Rochelle Walensky called for an “ambitious” overhaul of the agency.

CDC faces criticism over public health emergency response

While CDC has faced criticism on its response to public health issues for years, public upset with the agency increased significantly during the Covid-19 pandemic. And dissatisfaction with the agency has continued into the monkeypox public health emergency as well.

Many experts believe the agency took too long to acknowledge the coronavirus’s spread from Europe to the United States, to recommend masking, to announce the virus was airborne, and to implement systematic testing for emerging variants, the Associated Press reports.

“We saw during COVID that CDC’s structures, frankly, weren’t designed to take in information, digest it and disseminate it to the public at the speed necessary,” said Jason Schwartz, a health policy researcher at the Yale School of Public Health.

In addition, many experts have criticized the agency for prioritizing the collection and analysis of data rather than taking steps to address emerging public health threats.

“CDC is a great organization, but it has always functioned like a big academic health system and not an emergency response entity,” said Georges Benjamin, executive director of the American Public Health Association. “And the world has changed a lot.”

On Wednesday, Walensky acknowledged CDC’s shortcomings in its pandemic response. “For 75 years, CDC and public health have been preparing for COVID-19, and in our big moment, our performance did not reliably meet expectations,” Walensky said.

“It’s not lost on me that we fell short in many ways” responding to the Covid-19 pandemic, Walensky said. “We had some pretty public mistakes, and so much of this effort was to hold up the mirror … to understand where and how we could do better.”

Walensky calls for an ‘ambitious’ overhaul

In April, Walensky requested an in-depth review of CDC, which would help inform an “ambitious” overhaul of the agency, which CDC leaders are calling a “reset.”

“The goal was to learn how to pivot our long-standing practices and adapt to pandemics and other public health emergencies, then to apply those lessons across the organization,” Walensky said.

“As a long-time admirer of this agency and a champion for public health, I want us all to do better,” she said. ” … I feel like it’s my responsibility to lead this agency to a better place after a really challenging three years.”

“My goal is a new, public health, action-oriented culture at CDC that emphasizes accountability, collaboration, communication and timeliness,” Walensky added.

“For CDC to be more effective, we must build on the lessons learned from COVID-19 to improve how we deliver our science and programs,” Walensky noted, adding that this must include sharing scientific data and findings more quickly, and “translating science into practical, easy-to-understand policy.”

To accomplish the agency’s goals, Walensky said “there are some areas that will require a reorganization,” which include:

• Publishing preprint reports to quickly distribute actionable data, rather than waiting for research to undergo peer review and publication by CDC’s Morbidity and Mortality Weekly Report
• Reorganizing CDC’s communications office and improving the agency’s websites to make its guidance more accessible to the public
• Setting a six-month minimum CDC leaders can devote to outbreak responses to address a turnover problem that has resulted in knowledge gaps and miscommunications
• Creating a new executive council to help the CDC director determine the agency’s strategies and priorities
• Naming Mary Wakefield, who previously headed the Health Resources and Services Administration and served as the no. 2 administrator at HHS during the Obama administration, as CDC’s senior counselor to implement the proposed changes
• Notifying CDC’s organization chart to undo certain changes made during the Trump administration
• Creating an office of intergovernmental affairs to foster partnerships with other agencies
• Establishing a higher-level office on health equity

In addition, Walensky said she plans to “get rid of some of the reporting layers that exist, and I’d like to work to break down some of the silos.” While she did not go into further detail, she emphasized that the overall changes are more focused on rethinking how the agency conducts business and motivates employees, and less about redrawing the organization chart, AP reports.

“This will not be simply moving boxes” on the organization chart, Walensky noted.

While the reorganization proposal must be approved by the HHS secretary, CDC officials said they hope to have a finalized set of changes approved and implemented by early 2023.

From HealthcareDive

Dive Brief:

• About 17% of enrollees in Medicaid and the Children’s Health Insurance Program, or 15 million people, could lose their coverage when states resume regular eligibility checks once the COVID-19 public health emergency ends, HHS projected in a report from the Office of the Assistant Secretary for Planning and Evaluation.
• Loss of eligibility will require 9.5% of beneficiaries to transition to another source of health insurance, while nearly 8% will leave the program despite remaining eligible due to difficulty navigating the renewal process and other administrative issues, HHS reported.
• The agency said it is taking steps to reduce the risk of people becoming uninsured at the end of the public health emergency, including working with state and federal marketplaces to facilitate enrollment in other coverage options and stepping up outreach and education efforts. About 5.3 million children and 4.7 million young adults ages 18 to 34 are predicted to lose coverage. Of those, nearly a third are Latino and 15% are Black.

Dive Insight:

Health policy experts have been sounding the alarm about potential coverage losses for millions of Americans, including children, when pandemic protections expire. The nation’s uninsured rate fell to a historic low of 8% in the first quarter of this year, due in large part to the suspension of Medicaid coverage terminations that has swelled the number of participants in the program.

To help mitigate the disruption, the CMS issued guidance to assist states in November 2021 for transitioning those who will lose Medicaid and CHIP eligibility to other health insurance, such as subsidized plans, through Affordable Care Act marketplaces.

The extension of premium subsidies in the new Inflation Reduction Act is expected to improve access to alternative coverage for some losing Medicaid eligibility at the end of the public health emergency. The legislation extends enhanced marketplace subsidies until 2025.

Of those predicted to lose Medicaid and CHIP eligibility, 2.7 million people are expected to qualify for marketplace premium tax credits, the ASPE report said. Among this group, more than 60% are expected to qualify for zero-premium marketplace plans under the provisions of the American Rescue Plan. Another 5 million people are expected to obtain employer-sponsored insurance.

An estimated 383,000 people projected to lose Medicaid eligibility would fall in a coverage gap in the 12 non-expansion states because they have incomes too high for Medicaid but too low for marketplace tax credits.

Coverage losses due to administrative hurdles are also a high risk due to the volume of redeterminations that states must conduct and the length of time since Medicaid agencies last communicated with many beneficiaries, ASPE warned. The CMS is coordinating efforts with state Medicaid and CHIP agencies to minimize coverage lapses, the report added.