At a Glance…

  • House passes the Build Back Better reconciliation bill
  • Cures 2.0 legislative text is released
  • Biden Administration expands COVID-19 vaccine production
  • And more…

House Democrats pass the Build Back Better Agenda

The House passed the almost $2 trillion Build Back Better (BBB) reconciliation bill, sending it to the Senate where it is expected to undergo significant changes before any possible passage. The House-passed bill would pave the way for the greatest expansion of federal child-care assistance in history, seeking to fund free, universal prekindergarten for all American children ages 3 and 4. Targeting health care, the measure would offer new Medicare benefits covering hearing services and empowers the government for the first time to negotiate some prescription drug prices, aiming to lower the costs that seniors pay for lifesaving medicines such as insulin. Specific policies in the bill include:

  • Guaranteed four weeks of paid family and medical leave to all workers to welcome a new child, recover from a serious illness, or care for a seriously ill family member. The United States is the only industrialized nation without a national standard of paid leave.
  • Capping out of pocket spending on medications, including an annual $2000 limit on how much seniors in Medicare pay out of pocket for prescription drugs, which would affect an estimate 1 million older Americans.
  • Capping the price of insulin at $35 a month for all Americans.
  • New Medicare benefits for hearing services for seniors. Audiologists and other hearing specialists would qualify for Medicare reimbursement, and the program also would cover the cost of hearing aids for seniors.
  • Expanded Affordable Care Act insurance subsidies for lower and middle class patients.
  • A new program that would allow individuals in the Medicaid gap to buy private ACA health plans without monthly premiums, which could expand health insurance to 4 million currently uninsured people.
  • A 6 percentage point increase in federal Medicaid matching funds for home and community-based services (HCBS), that help seniors and people with disabilities with daily self-care and independent living needs.
  • Allow Medicare to negotiate prices with drug companies for a small number of high-cost drugs that lack generic or biosimilar competitors.

The measure is now with the Senate, where negotiations remain ongoing. Senators Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ) have consistently opposed major provisions in the legislation, and have withheld their needed votes as the bill continues to be negotiated. Additionally, Democrats are relying on a process called budget reconciliation, which prevents Senate Republicans from filibustering the bill, but has the tradeoff of having strict and complex budgetary requirements that will require the Senate Parliamentarian to adjudicate before a vote can occur. The Congressional Budget Office (CBO) has scored the legislation as costing $376 billion over the next ten years, without taking into account significant savings from new IRS enforcement.

Upton-DeGette release Cures 2.0 bill text

Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) introduced their bipartisan Cures 2.0 legislation, which is designed to reimagine how the US conducts biomedical innovation. Among key provisions of this legislation is the authorization for the Advanced Research Projects Agency for Health (ARPA-H), which is designed to invest in high-risk, high-reward biomedical innovations that would otherwise be unlikely to be funded. AcademyHealth has been in communication with Congress, NIH, and the White House about the importance of ARPA-H being designed with a focus on equitable and efficient delivery to reduce rather than expand health disparities. The former director of DARPA, Arati Prabhakar, argued that ARPA-H is an opportunity to consider the root causes of poor US health outcomes, including obesity and the opioid crisis. She noted that focusing just on the science of ARPA-H limits their work to inputs rather than outcomes.

It is unclear when Cures 2.0 will be marked up or voted on by Congress, but expectations are that it could happen in the next calendar year.

CMMI refocuses on making payment models more streamlined and equitable

The Center for Medicare and Medicaid Innovation (CMMI) released a “strategy refresh” designed to inform how models are evaluated and crafted over the next decade. A key new goal is to judge the success of a model not only on whether it has cost savings for Medicare, but whether it improves health equity. CMMI has said this new strategy will have the goal of achieving equitable outcomes through high-quality, affordable, person-centered care.

Biden nominates Robert Califf for head of the FDA

President Joe Biden nominated former Food and Drug Administration head Robert Califf to return to the agency as its commissioner, choosing a familiar name to lead the regulator after a drawn-out search. Dr. Califf served as FDA Commissioner for less than a year at the end of the Obama Administration. Janet Woodcock, a longtime top agency official, has served as acting commissioner during the search process, and was at one point considered a leading contender for the position. But her role overseeing the FDA's main drug review office as opioid overdoses became a nationwide epidemic drew criticism from lawmakers, as did the agency's controversial approval of Biogen's Alzheimer's drug Aduhelm under her watch. Dr. Califf may not have a smooth Senate consideration as Democratic Senators Joe Manchin and Richard Blumenthal have already come out against his nomination due to his ties to pharmaceutical companies.


The Biden Administration plans a major expansion of COVID-19 vaccine production


The Biden administration, under pressure to increase the supply of coronavirus vaccines to poor nations, plans to spend billions of dollars to expand manufacturing capacity, with the goal of producing at least one billion additional doses a year beginning in the second half of 2022. The investment is part of a new plan, announced Wednesday by White House officials, for the government to partner with industry to address immediate vaccine needs in the United States and overseas and to prepare for future pandemics. It comes on top of recent decisions to buy enough of Pfizer’s new Covid-19 pill for about 10 million courses of treatment, and to spend $3 billion on rapid over-the-counter tests, which are needed to detect the virus early enough for the Pfizer drug to work. The vaccination rate in low- and middle-income countries can be as low as single digits.

Partisanship becomes an increasingly important predictor of COVID-19 vaccination status

The KFF COVID-19 Vaccine Monitor and other surveys have consistently shown a strong relationship between partisan identification and how individuals view and experience the COVID-19 pandemic, on questions ranging from worries about getting infected, to self-reported behaviors like mask-wearing and social distancing, to views on vaccinations. This new analysis shows that although COVID-19 vaccination rates have increased over time with majorities across partisan groups reporting being vaccinated, Republicans make up an increasingly disproportionate share of those who remain unvaccinated and political partisanship is a stronger predictor of whether someone is vaccinated than demographic factors such as age, race, level of education, or insurance status. These results suggest substantial challenges for any efforts to further increase vaccine uptake among U.S. adults, which may also affect acceptance of booster shots and COVID-19 vaccines for children as eligibility expands.

What I’m reading

Frustratingly, some 30 percent of U.S. health  care workers employed at hospitals remained unvaccinated as of Sept. 15, according to an analysis of Centers for Disease Control and Prevention data published by the Association for Professionals in Infection Control and Epidemiology. Health care facilities must follow the upcoming CMS rule mandating COVID-19 vaccines by January 4 or risk losing Medicare and Medicaid funding. The rule does not have a testing exemption. Beyond the financial necessity of the CMS rule, health care workers need to be leaders in their communities about the importance of ending this pandemic through the safe, free, and effective vaccine choices.

An all too common challenge to patients accessing needed health care is being able to physically access it. Maliha et al wrote in Health Affairs about how transportation barriers to health care have been neglected and understudied. Underserved populations have reported that accessing transportation was a barrier in 10 to 50 percent of the time. This piece is a good reminder about the multi-disciplinary and whole-patient approach we need to take to reduce social determinants of health, like transportation access. The health care sector should apply more energy and innovation into narrowing the transportation divide.

We have a unique opportunity to make meaningful changes to redefine health care services as state agencies begin to receive more than $92 billion in federal support. Cohen et al argued in Health Affairs that the rush of federal funds from the American Rescue Plan Act and the Infrastructure Investment and Jobs Act provides a unique moment to extend their reach beyond the traditional health system to address the drivers of health, such as affordable housing, access to healthy food, reliable transportation, job training, and childcare.

As we all work to tear down the structural racism and the barriers it has created, we can look to the American Psychological Association, which released an apology for the role of the APA and psychologists in creating and perpetrating a system of racism. The APA said that it “failed in its role leading the discipline of psychology, was complicit in contributing to systemic inequities, and hurt many through racism, racial discrimination, and denigration of people of color, thereby falling short on its mission to benefit society and improve lives. APA is profoundly sorry, accepts responsibility for, and owns the actions and inactions of APA itself, the discipline of psychology, and individual psychologists who stood as leaders for the organization and field.” This resolution can be a blueprint for how we all think of our organizations and roles, and the fierce urgency of doing better.

From misinformation on vaccines to climate change to even the integrity of our elections, our country is facing a true crisis of trust and truth in our institutions and amongst ourselves. As an organization focused on creating evidence-based solutions for our health care system, we understand the dire health threat that lies and disinformation can cause. The Aspen Institute’s Commission on Information Disorder released a report that sought to create a framework of action with 15 recommendations for how government, private industry, and civil society can help to increase transparency and understanding, build trust, and reduce harms.

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