Weekly Roundup: May 5, 2023

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Coalition to End Social Isolation & Loneliness Holds Annual Connections at the Capitol

The Coalition to End Social Isolation & Loneliness (CESIL) brings together a diverse set of national organizations, including consumer groups, health plans, health care providers, technology innovators, patient and family advocates, and community-based organizations to develop and advocate for federal policy solutions to address the epidemic of social isolation and loneliness. Each June, alongside their partners at the Global Initiative on Loneliness and Connection (GILC), Marmalade Trust, and Humana’s Far From Alone campaign, they activate local communities, policymakers, and innovators to share resources, identify areas of collaboration, and educate the public on the importance of belonging and resiliency. This year’s event, Connections at the Capitol: Discussions on Loneliness, Isolation, and the Path Forward, will be held on June 13th, both virtually and in-person, in the U.S. Capitol Visitor Center in Washington, D.C. Register here.

Biden Administration Announces Executive Leadership Changes

Today, the Biden Administration announced two major leadership changes: the departure of Dr. Rochelle Walensky from the Centers for Disease Control (CDC) and the appointment of Neera Tanden as the President’s new Domestic Policy Advisor. Dr. Walensky has served as the CDC Director since January 2021, overseeing the Agency as it strived to respond to the COVID-19 public health emergency. She plans to depart the Agency at the end of June. Neera Tanden previously served as President and CEO of the Center for American Progress and as a Senior Advisor on issues related to health reform and the Affordable Care Act under the Obama Administration. As Domestic Policy Advisor, Tanden’s portfolio will include addressing issues related to economic mobility, health equity, immigration, and education.

KFF Report Highlights Tough Tradeoffs Under Republican Work Requirement Plan

Yesterday, the U.S. Food and Drug Administration (FDA) announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. Rexulti is a drug used to treat schizophrenia, major depressive disorder and psychosis, however, this is the first FDA-approved treatment option for agitation associated with dementia. Agitation is considered to be among the most persistent, complex, stressful and costly aspects of care among patients with behavioral and psychological symptoms of dementia. The effectiveness of Rexulti for the treatment of agitation was determined through two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies, among participants between the ages of 51 and 90 who had a probable diagnosis of Alzheimer’s dementia, a score between 5 to 22 on the Mini-Mental State Examination, and exhibited the type, frequency, and severity of agitation behaviors that require medication.

Executive Action

Last Friday, the Biden-Harris Administration released the multi-year Alternatives, Rehabilitation, and Reentry Strategic Plan aimed at strengthening public safety by reducing unnecessary criminal justice system interactions; supporting rehabilitation during incarceration; and facilitating successful reentry. The plan builds on President Biden’s Safer America Plan – his comprehensive strategy to prevent and combat gun violence – and outlines more than 100 concrete policy actions to improve the criminal justice system and strengthen public safety by leveraging data, research, and strategies from state and local governments across the country. The Strategic Plan supports justice-involved persons and promotes public safety by utilizing a whole-of-government approach through which the Biden-Harris administration will: 1) Expand access to health care; 2) Secure access to safe and affordable housing; 3) Strengthen access to banking and other financial services, among other improvements.

Administrative Action

On Monday, the Centers for Medicare and Medicaid (CMS) announced two investigations of hospitals that they assert did not offer necessary stabilizing care to an individual experiencing an emergency medical condition, in violation of the Emergency Medical Treatment and Labor Act (EMTALA). U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra sent a letter to hospital and provider associations across the U.S. stating that it is a health care provider’s professional and legal duty to offer necessary stabilizing medical treatment to a patient who presents to a covered emergency department and is found to have an emergency medical condition (or, if appropriate, to transfer them). CMS noted they will make sure that the hospitals come into compliance with federal law so that EMTALA’s guarantees are protected and take additional action as appropriate. Last year, HHS issued guidance and a letter from Secretary Becerra to reaffirm that EMTALA requires providers to offer necessary stabilizing care for patients suffering emergency medical conditions, which might include abortion care in certain situations.
On Tuesday, U.S. Surgeon General Dr. Vivek Murthy issued an advisory to address the nation’s epidemic of loneliness and isolation. The advisory also lays out a framework for a National Strategy to Advance Social Connection. The strategy calls for the strengthening of social infrastructure, enactment of pro-connection public policies, and mobilization of the health sector, among other actions. The framework provides recommendations for individuals, parents and caregivers, community-based organizations, schools and education departments, workplaces, health care systems and insurers, public health professionals, governments, media and entertainment, technology companies, researchers, and philanthropy groups on how to address the public health problem of social disconnection and strengthen social connection.

Regulatory Action

On Wednesday, the U.S. Food and Drug Administration (FDA) approved Arexvy, which is the first respiratory syncytial virus (RSV) vaccine approved for use in the U.S. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older. RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. According to the U.S. Centers for Disease Control and Prevention (CDC), each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older. The safety and effectiveness of Arexvy is based on the FDA’s analysis of data from an ongoing randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older. Participants will remain in the study through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination.
On Wednesday, the Drug Enforcement Administration (DEA) Administrator Anne Milgram released a statement on the DEA’s receival of a record 38,000 comments on its proposed telemedicine rules. The DEA will continue to allow doctors to prescribe controlled substances by telehealth while the agency works to finalize rules on prescribing following the end of the COVID-19 public health emergency. The statement then outlined the DEA’s decision to submit a draft Temporary Rule to the Office of Management and Budget entitled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” Further details about the rule will become public after its full publication in the Federal Register. The original DEA proposal would have extended COVID-19 prescribing flexibilities for 180 days. Afterwards, individuals would be able to use telemedicine to get an initial 30-day supply of certain DEA-regulated drugs, but be required to make an in-person visit to the doctor’s office afterwards for additional refills.

Congressional Action

On Tuesday, the Senate Committee on Health, Education, Labor, & Pensions held a session to advance four bipartisan bills that would increase access to generic drugs and reform pharmacy benefit managers (PBMs) practices as part of an overall effort to lower health care costs. Talks slowed amid allegations of reneging on agreements made while crafting the package. Chairman Sanders (I-VT) eventually postponed votes on the measures following criticism from numerous Republicans over whether to consider four amendments before receiving more information on their potential impacts from the Congressional Budget Office (CBO) and Food and Drug Administration (FDA). Ranking Member Cassidy (R-LA) expressed concerns regarding the Chairman’s failure to share FDA technical assistance on the amendments as well as cost scores from the CBO. Senator Kaine (D-VA) pushed to postpone the markup until after lawmakers could review all the data requested and had heard from major pharmaceutical executives at a scheduled hearing on May 10. Healthsperien’s full notes on the hearing can be found here.
Recently, the Senate Finance Committee majority released their findings from a secret shopper survey of twelve Medicare Advantage (MA) plans across six states to evaluate the accuracy of plans’ mental health provider listings. Of the 120 provider listings they attempted to contact, one-third were inaccurate, non-working numbers, or unreturned calls. Staff conducting the survey were only able to successfully make appointments 18 percent of the time. Based on these findings, the committee members concluded that the Centers for Medicare and Medicaid Services (CMS) must increase its oversight and audits of MA plan directories. It should also be noted that Congress can require additional regular audits, transparency, and financial penalties for non-compliance.

Medicaid

On Monday, the U.S. Government Accountability Office (GAO) announced the appointment of six new members to the Medicaid and CHIP Payment and Access Commission (MACPAC) and designated the Commission’s Vice Chair. The newly appointed members, who will serve and provide Congress with advice on both Medicaid and CHIP, include: 1) Timothy Hill, Vice President for Client Engagement at the American Institutes for Research 2) Carolyn Ingram, Executive Vice President of Molina Healthcare 3) Patti Killingsworth, Senior Vice President of Long-Term Services and Supports Strategy at CareBridge 4) Adrienne McFadden, Chief Medical Officer of Medicaid at Elevance Health 5) Jami Snyder, President and Chief Executive Officer of JSN Strategies. The GAO designated Robert Duncan, Executive Vice President and Chief Operating Officer of Connecticut Children’s, as the Commission’s Vice Chair.

Research

Recently, the Consumer Financial Protection Bureau (CFPB) published a report on high-cost specialty financial products, such as medical credit cards, that are sold to patients as a way to alleviate the growing costs of medical care. The report finds that specialty products are typically more expensive for patients than other forms of payment, including conventional credit cards, with interest rates often exceeding 25%. The report also details how these cards can add to the financial stress of medical bills, including decreased access to credit, costly and lengthy collection litigation, and an increased likelihood of bankruptcy. In addition, these products often have deferred interest plans, with all accrued interest potentially becoming due at the end of a defined period, which can prove especially expensive and unaffordable for patients.
The Centers for Disease Control and Prevention (CDC) published a new report that estimates drug overdose deaths involving fentanyl, methamphetamine, cocaine, heroin, and oxycodone in the U.S. in 2021. The report, which uses data from the National Vital Statistics System, provides national drug overdose death rates by sex, age, race and Hispanic origin, and public health region. From 2016 through 2021, the study found that age-adjusted drug overdose death rates involving fentanyl, methamphetamine, and cocaine increased, while drug overdose death rates involving oxycodone decreased. Notably, American Indian or Alaska Natives death rates were the highest for fentanyl, methamphetamine, heroin, and oxycodone, while non-Hispanic Black death rates were highest for cocaine and among those aged 25–64, the highest rate of drug overdose deaths involved fentanyl.