This Week’s Dose

Congress was in recess during the Memorial Day holiday week. Both the House and Senate will return the week of June 6, kicking off what could be a busy month, leading up to the Independence Day recess. Following an emergency markup of a gun control package by the House Judiciary Committee on June 2, the House is expected to consider that legislation next week and possibly additional bills on gun control. In the Senate—where the House legislation does not have 60 votes to pass—bipartisan negotiations continue on a more narrow response to the recent mass shootings. The next week may also bring some progress regarding pending health policy priorities, including the Food and Drug Administration (FDA) user fee programs and mental health reform, among others. 

Congress

House Judiciary Committee Advances Gun Control Package.  On June 2, the House Judiciary Committee held a markup—a rare occurrence, for a recess holiday week—of the Protecting Our Kids Act (H.R. 7910), a package of gun control bills that was introduced by Chairman Jerrold Nadler (D-NY) in response to recent mass shootings.

The legislation was advanced by a party-line vote of 25-19 and contains gun control measures relating to raising the age of sale to 21 for semiautomatic weapons, preventing gun trafficking, requiring that all firearms be traceable, safe storage provisions, closing the bump stock loophole in order to regulate bump stocks like machine guns, and placing restrictions on large capacity ammunition feeding devices.

The Protecting Our Kids Act is expected to be on the House floor next week, though the House vote will be largely symbolic, given that this bill likely does not have the 60 votes required to advance in the 50-50 Senate.

In the Senate, bipartisan negotiations led by Senator Chris Murphy (D-CT) are focused on provisions that could garner both parties’ support, including so-called “red flag” laws providing federal incentives to states to stand up programs to remove guns from those posing threats to themselves and others, school safety measures, and mental health provisions.

Administration

HHS Launches Environmental Justice Initiative.  On May 31, the Department of Health and Human Services (HHS) announced the establishment of an Office of Environmental Justice (OEJ) within the Office of the Assistant Secretary for Health’s Office of Climate Change and Health Equity (OCCHE). The OCCHE was created as part of President Biden’s January 2021 Executive Order on Tackling the Climate Crisis at Home and Abroad, focusing on government-wide efforts to address the climate crisis, and safeguarding public health and well-being as the U.S. confronts climate change.

The OEJ was created to better protect the health of disadvantaged communities and vulnerable populations on the frontlines of pollution and other environmental health issues.  It will serve as HHS’ hub for environmental justice policy, programming, and analysis, and will focus on:

• Leading initiatives that integrate environmental justice into the HHS mission to improve health in disadvantaged communities and vulnerable populations across the nation;

• Developing and implementing a department-wide strategy on environmental justice and health;

• Coordinating annual HHS environmental justice reports;

• Providing HHS’ Office of Civil Rights with environmental justice expertise to support compliance under Title VI of the Civil Rights Act of 1964; and

• Promoting training opportunities to build an environmental justice workforce

The Office of Climate Change and Health Equity (within which OEJ is now housed) was established in 2021, though it still awaits federal funding.  The FY 2023 budget request includes $3 million for the office; however, Republicans have questioned if climate change resources should trump other health care priorities.  The Federal Register notice formally establishing the OEJ can be found here. 

CMS to Use Savings to Lower Part B Premiums in 2023.  On May 27, HHS announced that Medicare Part B premiums paid by Medicare beneficiaries for 2023 should be adjusted downward to account for an overestimate in costs attributable to the inclusion of new Alzheimer's drug Aduhelm within Medicare in 2022.

About half of the 2022 premium increase, set last fall, was attributed to the potential cost of covering Aduhelm despite not yet knowing the final cost of the product or how Medicare would cover the new drug.  Subsequent price reductions and the Centers for Medicare & Medicaid Services’ (CMS’) decision to only cover Aduhelm for beneficiaries as part of a clinical trial resulted in an inflated 2022 premium.

CMS recently issued a five-page report to the Secretary that reexamined the 2022 premium increase, finding it should be significantly lower. Due to the legal and operational hurdles in adjusting Medicare premiums midstream in 2022, the reduction in premium costs attributable to lower-than-expected Part B spending on Aduhelm will be incorporated into Medicare premiums next year.

The report stated:  “CMS found that incorporating the premium effects of Aduhelm’s price reduction and the subsequent National Coverage Determination into the 2023 premium is the only practically feasible option, as implementing a mid-year administrative redetermination of the 2022 premium was not found to be operationally possible during 2022, and also determined CMS does not have sufficient authority to send premium refunds directly to beneficiaries unless there is excess payment relative to the established premium.”

2023 Medicare Part B premiums will be announced in the fall of 2022 through a notice in the Federal Register.

Quick Hits

• On June 2, the Medicare Trustees annual report was released, projecting that Medicare will remain solvent through at least 2028—two years later than was projected last year. Nonetheless, Republicans are expected to leverage the six-year runway to make the case for Medicare spending reductions to extend the durability of existing resources.

• The Modernization Subcommittee of House Republicans’ Health Futures Task Force unveiled proposals to expand access to telehealth services beyond the pandemic, address fraud, waste, and abuse through the utilization of state-of-the-art technology, and expand access to patient-centered technologies.  (See the Task Force’s one pager for additional details.)

• The Senate Committee on Health, Education, Labor and Pensions (HELP) will hold an executive session on June 8, to mark up its FDA user fee package (S. 4348) and a bill that expands the allowable use criteria for new access points grants for community health centers (S. 958).

• New Kaiser Family Foundation analysis found that private insurers are expected to issue approximately $1 billion in Medical Loss Ratio (MLR) rebates to consumers across all commercial markets in 2022, under the ACA requirement that limits the amount of premium income that insurers can keep for administration, marketing, and profits.

• The U.S. Government Accountability Office (GAO) found in a new report that limited data hinders the understanding of the role and value of short-term insurance plans during the COVID-19 pandemic.

• CMS outlined its strategy to strengthen behavioral healthcare in a Health Affairs article.

The Health Resource and Services Administration’s Maternal and Child Health Bureau released a Blueprint for Change  for a system of services for children and youth with special health care needs (CYSHCN).  The framework was designed to ensure that CYSHCN are able to thrive in systems that support their families and their social, health, and emotional needs, and that ensure dignity, autonomy, independence, and active participation in their communities.

Health Policy Breakroom Podcast

Congress created the 340B Program in 1992 to address drug prices. Since then, a flurry of lawsuits covering many different drug categories and cases have been filed connected to 340B challenges. Emily Cook and Rodney Whitlock visit to discuss the variety of stakeholders in the healthcare space following this issue, creating the need for our just released 304B Litigation Tracker that routinely monitors legal action and decisions.

Next Week’s Diagnosis

Gun control will remain top of mind as the House takes up a legislative package of gun control measures and bipartisan negotiations continue in the Senate on a potential compromise in response to recent gun violence.