At a Glance…
- CMS considering new rules for reviewing medical devices
- FDA increasing scrutiny on racial biases in pulse oximeters
- Congressional Democrats considering maternal health package for December
- And more…
CMS is considering new processes to review new medical devices
Centers for Medicare and Medicaid Services (CMS) officials wrote in JAMA about a vision for a new pathway for medical device review processes for Medicare that will be officially proposed in the coming months. A federal regulation from January 2021 would have automatically provided 4 years of Medicare coverage, regardless of where in the US a beneficiary lived, for newly approved medical devices. However, this rule was seen not sufficiently protecting patients or allowing for robust evidence of value for the Medicare population. This rule was rescinded in November 2021, and CMS began the process of developing a replacement. The rule that is being developed is based on the following principles:
- Manufacturers may enter the process on a voluntary basis. This process will be limited to medical devices that fall within the Medicare statute and are relevant to the Medicare population.
- The CMS may conduct an early evidence review (before the device secures FDA marketing authorization) and discuss with the manufacturer the best Medicare coverage pathway, depending on the strength of the evidence collected.
- At the manufacturer’s request, CMS may initiate the coverage review process before FDA market authorization, which could require developing an additional evidence development plan and confirming that there are appropriate safeguards and protections for Medicare beneficiaries.
- If CMS determines that further evidence development is the best coverage pathway, the agency would explore how to reduce the burden on manufacturers, clinicians, and patients while maintaining rigorous evidence requirements.
FDA increasing scrutiny of pulse oximeters as evidence of racial biases mount
The FDA convened an advisory meeting on November 1 to discuss ongoing concerns that pulse oximeters are less accurate for patients with darker skin pigmentations. Researchers have warned the FDA that flawed readings on these devices, especially among Black and dark-skinned patients, might have contributed to deaths during the coronavirus pandemic. Studies have shown for decades that these devices were less accurate on darker skin, which could lead to a false healthy reading when more accurate measures would have shown concern for practitioners. Experts told the FDA the flawed readings might have driven some of the racial and ethnic disparities exposed in studies reviewing access to Covid treatments. Authors of the studies emphasized that blood-oxygen levels were often a key factor in deciding who would receive certain medicines, oxygen therapies and even hospital beds at times when all were in short supply.
House Democrats push for maternal health package in omnibus
Democratic Reps. Robin Kelly (Ill.) and Lauren Underwood (Ill.) are gathering support for a package of maternal health bills that includes mandatory year-long Medicaid coverage after someone gives birth. Democrats have gotten pieces of the package signed into law this Congress, including funds for states to voluntarily extend postpartum coverage. Many provisions were slated to be part of a partisan domestic policy bill that eventually became the Inflation Reduction Act, but weren’t included in the version that became law. They have 120 members of Congress so far signed onto a letter of support. Democrats are also asking for an extension of CHIP funding and Medicaid funding for territories, she said.
HHS creating Action Alliance to advance patient and workforce safety
The Department of Health and Human Services, including leaders from the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration, convened on November 14 with certain health system leaders and patient safety advocates they invited to discuss the department’s plan to launch next year a National Healthcare System Action Alliance to Advance Patient Safety. More information about the proposed Action Alliance is available here.
Biden Administration calls for $10 billion in emergency COVID-19 funding
The Biden Administration has called on Congress to provide nearly $48 billion in supplemental funding before the end of they year, split between resources for Ukraine and public health funds. They are asking for $10 billion in emergency health funding, with more than $9 billion going toward Covid vaccine access, next-generation Covid vaccines, long Covid research and more. About $750 million would be spent on efforts to control the spread of monkeypox, hepatitis C and HIV.
NCHS finds that 7 percent of Americans report they are experiencing long COVID
The National Center for Health Statistics (NCHS) reported that in October, 7 percent of American adults reported that they are actively experiencing long COVID. This research has helped to provide further data on a disease that has significantly affected both the health care system and the economy more broadly. Of those that reported having long COVID, nearly a quarter said that the condition has significantly limited their day-to-day activities.
NIH named Dr. Joni Rutter as director of the NCATS
NIH announced Joni L. Rutter, Ph.D., as director of NIH’s National Center for Advancing Translational Sciences (NCATS). Dr. Rutter has served as NCATS acting director since April 2021. She officially began her role as NCATS director on Nov. 6, 2022. Dr. Rutter will oversee a diverse portfolio of research activities focused on improving the translational process of turning scientific discoveries into health interventions. The portfolio includes the Clinical and Translational Science Awards (CTSA) Program, which is one of NIH’s largest supported programs and has played an important role in the agency’s COVID-19 response. In addition, she will direct innovative research programs to advance diagnoses and treatments, including gene therapies, for some of the more than 10,000 known rare diseases. She also will lead labs at NIH that drive team science with the private sector to create and test innovative methods for improving the drug development process.
AMA president called out misinformation and politicization of health care for physician burnout
American Medical Association president Dr. Jack Resneck Jr. decried laws that stop physicians from providing reproductive healthcare, during an Interim Meeting of the American Medical Association House of Delegates. Physicians are facing unprecedented disinformation attacks and government interference in the practice of medicine, fanning flames of an already concerning physician burnout crisis, Resneck told physicians and medical students. Disinformation since the Dobbs v. Jackson Women's Health Organization and Roe v. Wade Supreme Court decisions threaten the patient-physician relationship, Resneck said. He urged Congress to prevent looming end-of-year Medicare cuts that could cut payments to physician practices during a time of rising inflation and the continuing pandemic.
CMS is hiring 200 people to implement the Inflation Reduction Act
CMS is staffing up programming that is necessary to implement the Inflation Reduction Act (IRA) provisions that allow Medicare to negotiate drug prices aps out-of-pocket spending for prescription drugs in Medicare, and improve access to affordable health insurance coverage at HealthCare.gov. There are over 200 positions that CMS is hiring.
March of Dimes identifies worsening maternal and infant health outcomes
The 2022 March of Dimes Report Card released the state of maternal and infant health in the United States (U.S.), Washington, D.C. and Puerto Rico. The report card indicates the maternal and infant health crisis is worsening for all families. The report found that the U.S. preterm birth rate increased to 10.5 percent in 2021, representing an increase of four percent since 2020. This is the worst rate we have seen since 2007 and drops the U.S. Report Card grade from a C- to a D+. Overall, 45 states, Washington D.C. and Puerto Rico experienced an increase in preterm birth rates, while four states saw a decrease.
HHS commission releases inaugural report on equity for Asian-Americans, Native Hawaiians, and Pacific Islanders
The President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders released its inaugural report, publicly detailing more than a dozen recommendations that were transmitted to President on how to advance equity, justice, and opportunity for AA and NHPI communities.
HRSA investing $13 million to grow and strengthen the nursing workforce
The Health Resources and Services Administration (HRSA) awarded $13 million to bolster nursing education and training to grow the nursing workforce and improve access to nursing education. One significant factor constraining admissions to nursing schools is the limited availability of nursing preceptors (experienced licensed clinicians who supervise nursing students during their clinical rotations). Nursing preceptors are a critical bridge between training and practice, providing direct instruction to nursing students in the clinical setting. Without sufficient preceptors, nursing schools cannot admit as many students, new students are delayed in starting their clinical rotations, and prospective nursing students may be stymied and choose other career paths.
What I am reading
AcademyHealth hosts the Medicaid Medical Directors Network (MMDN), a dynamic learning network comprised of senior clinical leaders that centers on advancing and using evidence-based medicine, improving and measuring healthcare quality, and redesigning healthcare delivery within Medicaid. A panel of Medicaid Medical Directors from the MMDN briefed our organizational members on how Medicaid is responding to Dobbs, as Medicaid is the largest payer of pregnancies in the US. The conversation focused on how Medicaid can respond to maximize patient health outcomes in a shifting and challenging legal landscape. You can read about the briefing here and learn more about our organizational membership and the briefings we host here.
When is it appropriate for a hospital to send low-income patients into debt collection? According to Chokshi and Beckman in JAMA, the answer is never. They argue that it is time to expand the list of medical “never events”, i.e. events that were preventable adverse events that indicate a severe problem with the quality or safety of care, should be expanded to include other behaviors that can harm patients. The authors seek to change hospital behavior that is seen as a routine and necessary harm into something unacceptable. They propose that this list should include sending debt collectors after low income patients, cutting community benefit spending, paying less than a living wage to employees, obeying price transparency laws, and ending racial disparities.
Lagu et al released a troubling article in HealthAffairs where they found that a critical barrier people with disabilities face in accessing care is that many physicians do not want to see these patients. This article used physicians focus groups to identify physical, communication, knowledge, structural, and attitudinal barriers to care for people with disabilities. Physicians reported feeling overwhelmed by the demands of practicing medicine in general and the requirements of the Americans with Disabilities Act of 1990 specifically; in particular, they felt that they were inadequately reimbursed for accommodations. Some physicians reported that because of these concerns, they attempted to discharge people with disabilities from their practices. These findings suggest that physicians’ bias and general reluctance to care for people with disabilities play a role in perpetuating the health care disparities they experience.
NIH leaders wrote in The Lancet about how the NIH Climate Change and Health Initiative can be used to address the risk to human health posed by climate change. Climate change causes health crises through the emergence and spread of infectious diseases, malnutrition, and extreme weather-related morbidities.