We'd take a breath - but
We need to save oxygen
For the next deep dive
The Rundown
- The congressional schedule gets more complicated just ahead of recess
- House passes two-year extension of Medicare telehealth waivers
- CMS releases Maternity Care Action Plan
- HHS issues nondiscrimination in healthcare proposed rule
- The latest from our desks
- Join Duke Health Advocacy Network
Federal Updates
Save the… well, everything… for last
Congress was already careening toward the August recess period with a packed agenda and growing checklist of priorities – then came a Senate announcement on appropriations and the return of reconciliation. The House is scheduled to begin its recess later today, and the Senate is supposed to depart by the end of next week. Here’s where things stand as of publication time.
FY 2023 Appropriations
Surprise! A week after the House passed a minibus of six of its annual appropriations bills, Senate Democrats released their much-anticipated versions of FY 2023 spending legislation, including funding for the Department of Health and Human Services (HHS) and medical research at the Departments of Defense and Veterans Affairs.
Highlights include:
- $46.959 billion for the NIH base budget, which is $2 billion above the FY 2022 level. Additionally, the bill provides $1 billion for the recently created Advanced Research Projects Agency for Health (ARPA-H). Overall, the total program level would be $47.959 billion. The Clinical and Translational Science Awards would receive $625.4 million, an increase of $18.8 million above the FY 2022 enacted level, and includes important language maintaining support for CTSA Hubs.
- $52 million for the 12 Regional Biocontainment Labs (RBLs), including the one at Duke, which is level funding compared to the FY 2022 enacted level.
- $111.8 million, which is an increase of $30 million, for the National Child Traumatic Stress Initiative.
- $385.4 million for the Agency for Healthcare Research and Quality, which is an increase of $35 million above the FY 2022 enacted level.
- $35 million for firearm injury mortality and prevention research at the CDC, which is an increase of $22.5 million above the FY 2022 level; and $25 million, which is an increase of $12.5 million above the FY 2022 enacted level, at NIH.
- $318.5 million, an increase of $38 million, for Nursing Workforce Development programs at the Health Resources and Services Administration.
- $10 million, an increase of $8 million, for the MISSION Zero Military-Civilian for the Trauma Readiness grant program to support cross-training of military trauma professionals in civilian trauma centers.
- $916 million, an increase of $34 million, for the VA’s Medical and Prosthetic Research program.
- Increased overall funding for the DOD’s Congressionally Directed Medical Research Program.
It’s unclear when or if the Senate will take up their appropriations bills individually, and the House has yet to take up and pass its Committee-adopted bill supporting HHS priorities. We will continue to actively engage our delegation and Committee staff on these issues as the FY 2023 appropriations process moves forward.
USICA/CHIPS
This week, Congress passed the long-awaited “CHIPS-Plus” (now called the CHIPS and Science Act of 2022) legislation, a slimmed down version of its massive competitiveness legislation (the artist formerly known as USICA and America Competes). The bill includes several provisions totaling $54 billion to fund, incentivize, expand, strengthen, and support semiconductor manufacturing. The bill also includes another $200 billion to reauthorize the National Science Foundation and the Department of Energy Office of Science for five years.
Passage of the bill checks off a big legislative priority for the Biden administration, provides both parties with some election messaging fodder to take back home during recess, and clears the way for consideration of a new reconciliation package. Yes, we’re not kidding. It’s back (more below).
Build Back (Manchin)
The on-again-off-again negotiations related to the Democrats’ scaled-down, $1 trillion reconciliation package may be nearing its end. In a town where it’s notoriously hard to keep anything secret for long, Senate Majority Leader Chuck Schumer (D-NY) and Senator Joe Manchin (D-WV) surprised Washington late Wednesday when they announced a deal had been reached. Retitled the “Inflation Reduction Act of 2022,” the proposal includes roughly $370 billion in energy and climate spending, $300 billion in deficit reduction, three years of subsidies for Affordable Care Act premiums, prescription drug reform, and significant tax changes.
With the deal announced and the legislative text released, the bill now heads to the Senate parliamentarian to ensure its provisions are eligible under the reconciliation process. Senator Schumer has indicated he wants the Senate to advance the legislation sometime next week, although meeting this timeframe may be too aggressive. From there, the legislation would still need approval in the House of Representatives, where a segment of the House Democrats have previously expressed skepticism on the more limited nature of this bill. Can they get it done? Time will tell.
FDA User Fees
Believe it or not, this was supposed to be the easy one. What was once thought to be a priority that would quickly move through Congress on time has now become a question mark (Yeah, we know we need to be more specific). Pre-conference negotiations on user fee reauthorization language for the Food and Drug Administration (FDA) are in a dramatic pause after Senate Health, Education, Labor & Pensions (HELP) Committee ranking member Richard Burr (R-NC) withdrew from talks over concerns about "anti-competitiveness" provisions being added in the committee process and introduced a “clean” user fee bill, the Food and Drug Administration Simple Reauthorization Act, that is different from both the House-passed measure and one approved earlier this summer by the HELP Committee.
Senator Burr’s actions, intended to reset and reshape negotiations, are the result of concerns that the HELP Committee-passed bill would “undermine the very purpose of the user fee program… endanger[ing] the development of drugs for rare diseases, imperil[ing] intellectual property rights, threaten[ing] Americans’ access to breakthrough treatments and cures, and deter[ing] private sector innovation.”
What now? The current FDA user fee agreement expires on September 30, 2022, and there is a growing sense of urgency to break the impasse.
Our team will continue to advocate for Duke Health priorities and provide updates on these issues as they become available.
House passes two-year extension of PHE-related Medicare telehealth flexibilities
This week, the House overwhelmingly passed the Advancing Telehealth Beyond COVID-19 Act (H.R. 4040) by a vote of 416-12 with every member of the NC congressional House delegation voting in favor of the bill.
The bill would extend current Medicare COVID public health emergency (PHE)-tied telehealth flexibilities through the end of 2024, including the authority to permit audio-only services. Not included in the extension is a provision expiring at the end of this year that allows high deductible health insurance plans to cover virtual care for enrollees before they hit their deductibles – but advocates and policymakers continue to work separately to make that provision permanent.
Under current law, the expanded Medicare telehealth waivers would only be extended for 151 days beyond the end of the PHE, which is currently extended through mid-October. Congressional leaders have fought for the longer extension to allow for more time to collect data and work with stakeholders and the Centers for Medicare and Medicaid Services (CMS) on which expanded services should be made permanent.
The legislation likely has enough support to clear any procedural hurdles in the Senate – but it’s unclear whether a potential Senate vote will have to wait until after the upcoming August recess because of a crowded Senate calendar.
Our office has continually advocated in support of the extension and expansion of federal telehealth policies and will continue to work with Duke Health experts and national stakeholders as the process moves forward.
CMS releases Maternity Care Action Plan
This week, CMS unveiled its Maternity Care Action Plan to support the implementation of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. The Biden-Harris Blueprint, which is characterized as a whole-of-government approach to combatting maternal mortality and morbidity was released in June and reported on in our newsletter. The Blueprint released in June outlines specific actions to improve maternal health under five priority goals, including:
- Increasing access to and coverage of comprehensive high-quality maternal health services, including behavioral health services.
- Ensuring those giving birth are heard and are decision makers in accountable systems of care.
- Advancing data collection, standardization, harmonization, transparency, and research.
- Expanding and diversifying the perinatal workforce.
- Strengthening economic and social supports for people before, during, and after pregnancy.
According to the Maternity Care Action Plan, CMS has taken a holistic look at its policies and programs to identify opportunities to enhance maternity care delivered to enrollees in Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace, specifically, through a focus on driving improvements in access to and quality of care during pregnancy, childbirth, and the postpartum period.
The Action Plan also further identifies gaps in maternity care in CMS programs related to the five goals and recommends next steps to address each issue area.
HHS issues proposed rule on nondiscrimination in healthcare
This week, HHS announced a proposed rule to implement Section 1557 of the Affordable Care Act (ACA) that prohibits discrimination on the basis of race, color, national origin, sex, age, and disability in certain health programs and activities.
The proposed rule is intended to strengthen civil rights protections for patients and consumers in certain federally funded health programs and HHS programs and would replace a revised and scaled-back rule issued in 2020 by the previous administration. It is also intended to complement other Biden administration efforts to advance gender and health equity and civil rights, as outlined in President Biden’s Executive Orders on Preventing and Combatting Discrimination on the Basis of Gender Identity or Sexual Orientation, Protecting Access to Reproductive Healthcare Services, and Advancing Racial Equity and Support for Underserved Communities.
HHS is accepting public comment on the proposed rule through September 26, 2022.
From our desk(s): Duke Health GR this week
This week our team met with Dr. Geeta Swamy and Dr. Matt Barber to discuss updates and policy to inform our office’s work relating to maternal health, including efforts on the Black Maternal Health Momnibus.
We participated in community-wide and NC targeted advocacy activities in support of the telehealth extension legislation passed by the House and joined monthly call of the National Association of ACOs to discuss the latest advocacy and policy updates.
We continued advocacy efforts to urge CMS to update the hospital inpatient prospective payment system (IPPS) proposed rule for FY 2023 to more accurately reflect the cost of providing hospital care to patients.
Finally, members of our team also joined coalition and stakeholder strategy meetings on federal surprise billing rules implementation, data privacy, federal appropriations for medical research, and cybersecurity in healthcare.
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