The U.S. Department of Health & Human Services commissioned a report by the RAND Corporation to keep track of changes to health care delivery brought by the federal No Surprises Act passed last year.  This first analysis measures the effects of hospital consolidations across the country and is meant to set a baseline for future reports to Congress.  Among the key findings is strong evidence that hospital mergers and acquisitions increase healthcare services and spending prices; there is less conclusive evidence on how consolidation affects quality and patient access.  Studies on the impact on rural hospitals were inconsistent, raising concern and a call for more careful examination.

The Federal Office of Rural Health Policy is funding a new resource to assist states in conjunction with the National Conference of State Legislatures (NCSL) as they establish new licensure standards for Rural Emergency Hospitals (REH).  This new NCSL website includes information on the requirements for the REH designation and relevant state actions. State policymakers have an important role to play in establishing and regulating this new provider type, as REHs are required to meet applicable state licensing, staffing, educational training, and scope of practice requirements. State-level officials and other stakeholders may visit this webpage to find examples of specific actions state legislatures have either proposed or established related to REH licensure. At the Federal level, CMS intends to finalize policies on the REH Conditions of Participation (COPs), payment policies, and provider enrollment procedures this fall before the new REH provider type becomes effective January 1, 2023.

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.

The Centers for Medicare & Medicaid Services (CMS) has released the “Supporting Health Care Resiliency” cross-cutting initiative (CCI), along with updated guidance to help health care providers prepare for the ending of the COVID-19 public health emergency. CMS is taking these steps to continue to protect people and restore standards for compliance with CMS requirements.

Please review the attached blog and below web links explaining the coming changes for each provider type and a CCI fact sheet.

Web links:

CMS Blog: https://www.cms.gov/blog/creating-roadmap-end-covid-19-public-health-emergency

CCI Fact Sheet: www.cms.gov/files/document/health-care-system-resiliency-fact-sheet.pdf

COVID-19 fact sheets for each provider type: https://www.cms.gov/coronavirus-waivers

Updated waiver document: https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf

The Centers for Disease Control and Prevention (CDC) issued updated guidance on the use of JYNNEOS and ACAM2000 vaccines in the context of a public health emergency (PHE). These considerations include using an alternate regimen including intradermal administration and a smaller injection volume of the JYNNEOS vaccine under an Emergency Use Authorization (EUA). Read the full Interim Clinical Considerations.

The Association of Clinicians for the Underserved (ACU) STAR² Center invites the health center workforce, human resources, clinical, and C-suite staff to apply by Thursday, August 25 to be part of ACU’s upcoming Recruitment Boot Camp: Mental Health Staff Edition. This learning collaborative will take place over four sessions in September and October and will explore the special considerations necessary to recruit a diverse, mission-driven, and patient-centered mental health workforce. Learn from STAR² Center staff experts and Dr. Adijat Ogunyemi, a practicing clinical social worker and professor with extensive experience in the health center context. To apply for the boot camp, click here.

The virus may be rebounding worldwide. The Jerusalem area this year suffered an outbreak, and the virus showed up in London wastewater in June. On August 12, PBS Newshour reported that the Polio virus was found in New York City wastewater.