This Week’s Dose
Welcome to September—the Senate returned to session this week and worked largely on judicial nominations, while the House returns to session on September 13. The top item on Congress’s to-do list this month is to approve a stopgap funding bill, known as a continuing resolution (CR), before the fiscal year ends on September 30. The CR could also include some level of supplemental funding recently requested by the Biden Administration for COVID-19, monkeypox, natural disasters and the war in Ukraine. Congress will also seek to advance the reauthorization of US Food and Drug Administration (FDA) user fee programs this month, although roadblocks remain in the Senate.
Appropriators Work to Ready Continuing Resolution. As lawmakers return to Washington, DC, following the August recess, Congress’s top—and, arguably, only—“must pass” priority before the midterm elections is to assemble and enact a CR to extend current appropriations funding.
While House and Senate appropriators took steps this summer to advance the 12 annual appropriations bills for FY 2023 under regular order, none of these bills have been enacted, necessitating the stopgap CR to keep programs funded and avoid a government shutdown when the new fiscal year begins on October 1. The core of the CR is not expected to garner controversy on Capitol Hill, and lawmakers appear to be coalescing around an extension of funding into mid-December.
However, the CR could also become a vehicle for potential funding and policy add-ons, given that it is the final piece of legislative business expected before Congress breaks to campaign for the November 8 midterms. Such efforts would require bipartisan cooperation, given the evenly divided Senate and the need for 60 votes to advance the CR.
Democrats may seek to add all or part of the $47.1 billion supplemental request the Administration released on September 2. That request includes $22.4 billion to facilitate the purchase and development of next-generation COVID-19 vaccines and treatments and help restart programs that recently ran out of funds, including provision of additional free tests on COVID.gov. The request also includes $4.5 billion to help the government purchase and distribute a two-shot monkeypox vaccine, and funding requests in response to the ongoing war in Ukraine and recent natural disasters.
This week, Senate Republicans expressed skepticism about attaching some of these funds—particularly COVID-19 and monkeypox funding—to the CR, although discussions and negotiations will continue in the coming days.
Democrats also may seek to add additional provisions to the CR, which could include the reauthorization of FDA user fee programs, reforming federal permitting regulations for energy projects, and extension of several expiring provisions, including some impacting Medicare providers. We’ll provide additional updates throughout the month as Congress works within the limited number of legislative days left to enact a CR before October 1.
CMS Issues RFI on Promoting Efficiency, Reducing Burden and Advancing Equity. On September 6, the Centers for Medicare & Medicaid Services (CMS) released yet another request for information (RFI) seeking public input on access to healthcare and related challenges, understanding provider experiences, advancing health equity, and assessing the impact of waivers and flexibilities provided in response to the COVID-19 Public Health Emergency (PHE).
The RFI, titled Make Your Voice Heard: Promoting Efficiency and Equity Within CMS Programs, seeks to further CMS’s commitment to engaging and learning from partners and communities. CMS encourages comments from all interested stakeholders, including patients and their families, providers, clinicians, consumer advocates and healthcare professional associations. CMS also encourages comments from individuals serving and located in underserved communities, and from all CMS stakeholders serving populations facing disparities in health and healthcare. Comments are due by November 4 and can be submitted here.
HHS OIG Releases Telehealth Reports. On September 7, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two reports on telehealth usage in the Medicare program during the first year of the COVID-19 pandemic.
In both of the new reports, the OIG cited its March 2022 report, Telehealth Was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic, which found that more than 28 million Medicare beneficiaries used telehealth in the first year of the pandemic and that beneficiaries used 88 times more telehealth services during the first year of the pandemic than they did in the previous year.
One of the September 7 OIG reports, titled Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks, focused on providers’ billing for telehealth services in the first year of the pandemic and ways to address fraud, waste and abuse related to telehealth in the Medicare program. It found that only a small proportion of providers that billed for telehealth services (1,714 of the 742,000 providers examined) posed a high risk to Medicare and received a total of $127.7 million in Medicare fee-for-service payments. The report recommended that CMS conduct targeted oversight of telehealth to help ensure its benefits are realized while efficiently minimizing risk.
The other report, titled Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Than Others To Use Telehealth During the First Year of the COVID-19 Pandemic, focused on the characteristics of beneficiaries who used telehealth. It found that beneficiaries in urban areas were more likely than those in rural areas to use telehealth during the first year of the pandemic. The report also found that dually eligible beneficiaries, Hispanic beneficiaries, younger beneficiaries and female beneficiaries were more likely than others to use telehealth, and that beneficiaries almost always used telehealth from home or other non-healthcare settings. The report recommended that as policymakers and stakeholders consider permanent changes to Medicare telehealth services, they balance concerns about issues such as access, quality of care, cost, health equity and program integrity.
These OIG reports are part of a broader push by Congress and the Administration to examine current telehealth flexibilities and determine how to extend them beyond the COVID-19 public health emergency.
White House Releases New COVID-19 Preparedness Plan. On September 8, the White House released an updated National COVID-19 Preparedness Plan. According to the White House, the preparedness plan “lays out the roadmap to help us fight COVID-19 in the future as we begin to get back to our more normal routines.”
The plan is divided into four goals:
- Protect Against and Treat COVID-19 – focusing on continued vaccination efforts, vaccine manufacturing capacity, a nationwide Test to Treat initiative, sustaining and increasing domestic manufacturing of COVID-19 tests, and ensuring equitable access to public health resources
- Prepare for New Variants – focusing on improved data collection, supporting and utilizing improved FDA processes to expedite regulatory review of variant-specific versions of vaccines and treatments, and adding at-home tests, antiviral pills and masks for the general population to the national stockpile
- Prevent Economic and Educational Shutdowns – focusing on providing schools and businesses guidance, tests and supplies to stay open, and working with Congress to provide paid sick leave to workers who miss work because of COVID-19
- Continue to Vaccinate the World – focusing on leveraging the vaccine donation model to deliver the 1.2 billion doses the US committed to donate to the rest of the world.
Texas Judge Rules Against ACA Preventive Care Provisions. On September 7, a US district court judge for the Northern District of Texas issued a ruling that preventive care provisions in the Affordable Care Act (ACA) requiring private insurance plans to cover drugs that prevent HIV infection at no cost to patients violate religious rights.
The ACA requires that private insurers cover certain preventive health services, including STD screenings and HIV pre-exposure prophylaxis (PrEP) prevention drugs. In his ruling, the judge found that that the rights of the employers that brought suit have been violated under the Religious Freedom Restoration Act by the requirement that they sponsor health insurance that covers sexual health services such as PrEP drugs that help prevent the spread of HIV.
It is not yet clear whether enforcement will occur immediately and whether coverage requirements will be blocked for just those who brought suit, for everyone in Texas or nationwide. HHS is expected to appeal the ruling.
- The Medicare Payment and Advisory Commission held a two-day public meeting on September 1–2 focused on Medicare payment policies, including those related to Medicare Advantage, Part B drug prices and the Medicare wage index.
- CMS issued a proposed rule to simplify the processes for eligible individuals to enroll and retain eligibility in Medicaid, the Children’s Health Insurance Program and the Basic Health Program. Comments are due by November 7.
- The US Department of Homeland Security issued the Public Charge Ground of Inadmissibility final rule, which largely codifies 1999 field guidance governing public charge determinations—which can be used to deny entry to certain immigrants—and revokes the Trump Administration’s public charge 2019 regulation that considered the use of noncash assistance programs, including Medicaid and SNAP, in public charge determinations.
- CMS announced that the Medicare Shared Savings Program, through its work with accountable care organizations, saved Medicare $1.66 billion in 2021 while continuing to deliver high-quality care, marking the fifth consecutive year the program has generated overall savings and high-quality performance results.
- HHS Secretary Xavier Becerra issued a declaration under section 564 of the Federal Food, Drug, and Cosmetic Act to allow the FDA commissioner to issue emergency use authorizations for in vitro diagnostics to expand the availability of tests for monkeypox.
- HHS Secretary Becerra also issued a statement after signing a directive to ensure that the updated COVID-19 vaccine is widely available following the recent authorizations and recommendations from the FDA and the Centers for Disease Control and Prevention.
- A bipartisan group of representatives issued an RFI on Medicare payment system reform. Responses are due by end of day on October 31 and should be emailed in PDF format to firstname.lastname@example.org.
Next Week’s Diagnosis
The House and Senate will both be in session next week, as work continues on a CR to keep government programs funded until after the midterm elections. The House may also take up bipartisan legislation to related to Medicare Advantage prior authorization reforms.
For more information, contact Debra Curtis, Kristen O’Brien or Erica Stocker.
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