Weekly Roundup: October 21, 2022

HHS Renews Public Health Emergency Determination for COVID-19 Pandemic

The Kaiser Family Foundation recently held a panel on the commercialization of COVID-19. As the government’s emergency funding measures inevitably slow, access to COVID-19 vaccines, treatments, and screenings will vary depending on insurance coverage and level of cost sharing. Panel experts discussed how to protect those that are uninsured, since they stand to lose the most once government funding for COVID-19 eases. The panelists also highlighted the need for more consistent, intentional incentives to drive private sector investment for future pandemic countermeasures, such as the Biomedical Advanced Research and Development Authority’s (BARDA) public-private research partnership for Phase II and III trials. These collaborations help coordinate regulatory details with the Food and Drug Administration to advance approval and ramp up manufacturing accordingly. Without public incentives in place, the panelists argue biomedical therapeutics will be underinvested in, which you can read more about here.

Administration Action

• The Biden-Harris Administration announced the availability of Over-the-Counter (OTC) hearing aids for adults with mild-to-moderate hearing loss, following a final rule issued by the FDA in August 2022. Individuals can now buy hearing aids at stores or online without a prescription, exam, or audiologist fitting. The FDA estimates this could lower average costs by as much as $3,000 per pair—providing significant relief for the nearly 30 million Americans with hearing loss, including nearly 10 million adults under age 60.
• The Department of Health and Human Services of the Inspector General (HHS OIG) released a report describing how home health agencies (HHA) adapted during the COVID-19 public health emergency. Like other healthcare providers, HHAs struggled with staff shortages and implementing infection control strategies. While telehealth and other regulatory flexibilities partially eased these concerns, there were significant shortfalls. Given these challenges, and the potential end of the public health emergency in 2023, HHS OIG provided three recommendations to CMS: 1) evaluate how HHAs utilize telehealth across service types and patient characteristics; 2) examine how the regulatory flexibilities may have impacted home health care quality; and 3) develop or update emergency preparedness training for HHAs on responding to infectious disease outbreaks based on the lessons learned during COVID-19.
• The U.S Department of Health and Human Services (HHS) has announced a new funding opportunity of $15 million to scale certified community behavioral health clinics (CCBHCs) through the Bipartisan Safer Communities Act (BSCA). CCBHCs currently serve an estimated 1.5 million people and are a critical part of the safety net, providing care for people with serious mental illnesses and substance use disorders as well as those that are underserved including children and youth, and veterans. Starting in 2024, ten states will be chosen to develop behavioral health demonstration projects for a year, which includes clinic certification and establishing prospective payment systems for Medicaid reimbursable services.
• The Food and Drug Administration (FDA) Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted this week to remove Covis Pharma’s preterm birth drug Makena from the market after over ten years in the FDA’s accelerated approval pathway. The advisory committee largely agreed that Makena’s ability to reduce preterm birth and improve neonatal outcomes was limited with respect to its adverse effects. The developer, Covis Pharma, believes Makena should be allowed to stay on the market while the company conducts follow-up confirmatory studies. Black women are at higher risk for preterm birth rates, which can cause chronic health problems for babies throughout their lives. Although the advisory committee voted to remove the drug from the market, the ultimate decision is left to the FDA.
• This week, the Government Accountability Office (GAO) published two reports examining maternal health outcomes and access to obstetric services. Their analysis found that maternal deaths increased during the COVID-19 pandemic, and COVID-19 infections contributed to one out of four maternal deaths in 2020 and 2021. GAO noted that disparities in Black maternal mortality, preterm births, and low birthweight births persisted or grew during the pandemic, in comparison to white or Hispanic and Latina women. The Department of Health and Human Services (HHS) attributed some of these disparities to the pandemic’s worsening of social determinant of health factors such as living environment, chronic stress related to racism, and access to care.
• GAO’s second report similarly found that rural access to hospital obstetric services has declined since 2004, and that most of the closures occurred in rural counties with sparse populations, majority Black populations, and low incomes. Stakeholders GAO interviewed recommended three strategies to improve rural access to obstetrics services: increase Medicaid reimbursement, increase remote consultations between providers, and establishing regional partnerships between larger and smaller rural hospitals for care coordination and training.

Medicare

• The Centers for Medicare and Medicaid Services (CMS) released an evaluation report on phase two of the Medicare Advantage (MA) Value-Based Insurance Design (V-BID) model. This report covers the first two years of model implementation from 2020-2021. The model is designed to encourage the use of high-value care, promote person- and family-centered care, increase enrollee choice and access to high-quality, timely, and clinically appropriate care, and/or reduce the cost of care. The BDI component of the model allows participating MA organizations (MAOs) to offer V-BID flexibilities, rewards, and incentives, including additional supplemental benefits, rewards such as gift cards for completing activities focused on improving health outcomes, and rebates to plans that bid below the benchmark that can be passed directly from the MAO to plan enrollees as cash benefits. At-a-glance reports regarding the V-BID model and Hospice Benefit Component can be found here and here, respectively.
• The Alliance for Connected Care released a study on telehealth utilization and the potential financial impact of long-term telehealth expansion on the Medicare program. Key highlights from the report are provided below: According to the study, total evaluation and management (E&M) visits in 2021 remain below 2019 levels, even with telehealth services included. In 2021, telehealth services leveled off at around 5 percent of all E&M services. Telehealth did not add to the total volume of Medicare services in any subset of the telehealth-eligible services examined with the exception of home-based E&M visits. Patients who used telehealth did not have more revisits than patients with in-person care.

Medicaid

• CMS recently approved Arizona’s Medicaid section 1115 demonstration program, which bolsters healthcare quality and outcomes by addressing social determinants of health. The Housing and Health Opportunities program will address housing insecurity and its health effects by: 1) providing services to help more people become and stay stably housed; 2) supporting community and transitional housing for those with unique clinical needs; 3) offer rent and housing support for up to six months for those transitioning out of settings such as congregate settings, homeless shelters, and the child welfare system; and 4) offer case management, outreach, and education of these services.
• In guidance the Centers for Medicare and Medicaid Services (CMS) released earlier this week, CMS notified states that coverage for individuals enrolled in Medicaid through the optional COVID-19 group will end on the last day of the public health emergency (PHE). The fifteen states and three territories that elected to provide this coverage for COVID-19 vaccinations, testing, and treatments could choose to use state-only funding to continue coverage for these individuals (e.g. to continue a course of treatment or pay for vaccinations administered after the end of the PHE) but cannot claim the federal match. Additionally, states claiming the enhanced Federal Medical Assistance Percentages cannot terminate Medicaid enrollment for this coverage group before the end of the month in which the PHE ends due to the continuous enrollment requirement. To mitigate coverage gaps, CMS encouraged states to consider initiating Medicaid redeterminations for this group to see if they qualify for full Medicaid coverage before the end of the PHE.