Duke Health Government Relations continues to engage lawmakers in the 118th Congress on key health care issues impacting Duke, including those listed below. Please email us if you would like to be engaged on these issues. For the most up to date information, please subscribe to our newsletter and follow us on Twitter.
FEDERAL APPROPRIATIONS AND THE BUDGET
Federal funds help promote Duke Health’s multiple missions of research, education, and patient care. The National Institutes of Health (NIH) and the Department of Defense Medical Research Program are two of the primary sources of federal funding for biomedical research at Duke.
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In September 2024, Congress averted a government shutdown by passing a continuing resolution (CR) funding the federal government at current spending levels, kicking the ongoing debate over federal spending to after the November 2024 elections with the lame-duck session of Congress. The outcomes of the November elections will likely determine whether Congress decides to finalize FY 2025 spending in December, or instead move forward with another CR into the new year in order to give the new administration an opportunity to weigh-in on funding levels. While a CR keeps the government funded, operating under a CR provides uncertainty to federal agencies that rely on discretionary funding, including agencies at the Department of Health and Human Services (HHS). Our team is working with NC congressional offices to promote Duke Health policy and funding priorities for the current fiscal year.
In early-March, President Biden released his budget request for this fiscal year, outlining the administration’s funding preferences. The budget request would support $48.33 billion in discretionary funding for the National Institutes of Health (NIH), which is an estimated $871.5 million increase over current funding levels to the base budget. The budget request would continue to support the Advanced Research Projects Agency for Health (ARPA-H) and other administration priorities including cancer research and women’s health. Other research priorities were held steady or would face cuts, including a $75 million reduction to the Veterans’ Affairs Medical and Prosthetic Research Program. The budget would also support the elimination of facilities fees for telehealth and certain outpatient services; provide $1.3 billion in incentives for hospitals to defend against cyberattacks; require all health plans to cover mental health and substance use disorder benefits and have an adequate network of behavioral health providers; prioritize enforcement of essential practices requirements by FY 2029; and extend No Surprises Act balance billing requirements to ground ambulances.
Over in the House, Republican legislators introduced its own FY 2025 spending bill for HHS that included several messaging amendments for the House Republican majority. While the bill would mostly preserve funding for medical research, it would not include increases to keep up with biomedical inflation. The bill includes several important priorities that would specifically impact Duke Health, including funding for the network of 12 Regional Biocontainment Labs and the National Child Traumatic Stress Initiative, but it also proposes extensive funding cuts and new policies. Committee leadership has signaled that this bill is considered an opening offer and that a final bill will need to be more bipartisan in order to pass.
Status
Duke Health Government Relations is actively engaged in the budget and appropriations process and will continue to advocate for sustained and strengthened funding for Duke Health priorities.
Background
The White House typically releases its budget request to Congress in February of each year. The budget provides the administration's recommendations for federal spending, revenues, and programmatic priorities. While nonbinding, the president’s budget request is an indication of the administration’s spending and policy priorities for the coming fiscal year, including those for research and healthcare and how to invest in new and existing federal programs.
While the President must sign the twelve annual appropriations bills approved by Congress into law, Congress ultimately has the “power of the purse” to make final spending allocation decisions. The congressional budget process typically begins in the first quarter every year and may include a budget resolution to set targets for the appropriations committees in the House and Senate to begin making formal spending recommendations and drafting individual appropriations bills.
Engagement in the annual budget and appropriations process helps Duke Health Government Relations identify new opportunities for Duke Health priorities, or potential areas of concern that require strategic action.
PROTECTING AND SUPPORTING THE HEALTHCARE WORKFORCE
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In response to the increasing incidences of hospital violence across the country, Reps. Madeleine Dean (D-PA) and Larry Bucshon (R-IN) introduced the Safety from Violence for Healthcare Employees (SAVE) Act in June 2022 and again in April 2023. This bill would provide federal protections for health care workers who experience violence and intimidation in their workplace settings—making it a federal crime to assault or intimidate a hospital employee. The bill would also authorize grants to reduce the incidence of violence at hospitals, including violence or intimidation against hospital personnel in the performance of their duties. Duke Health strongly supports this legislation.
Status
Momentum for this legislation progressed over the months following its introduction, but the bill was left pending in the 117th Congress. Duke Health supports the current iteration of the SAVE Act (HR 2584), which was reintroduced in the 118th Congress in April 2023. NC Reps. Don Davis (D-NC-01), Deborah Ross (D-NC-02), Valerie Foushee (D-NC-04), Kathy Manning (D-NC-06), and David Rouzer (R-NC-07) cosponsor this important bill.
Additionally, in early 2022 Congress passed, and the President signed into law, the Dr. Lorna Breen Health Care Provider Protection Act to improve mental and behavioral health among health care providers. The law, among other provisions, provides grants to hospitals, medical professional associations, and other health care entities for programs to promote mental health and resiliency among health care providers. Duke Health is currently a recipient of one of the grants made possible through these efforts.
Background
According to a 2018 report from the Bureau of Labor Statistics, 73% of workplace injuries in the healthcare setting are due to violence. A survey of nurses in 2020 documented an uptick in violence against hospital employees linked to the pandemic: 44% of nurses reported experiencing physical violence and 68% reported experiencing verbal abuse during the early days of the COVID pandemic.
Dr. Craig Albanese, Duke Health System Chief Executive Officer, published an op-ed in the Charlotte Observer noting that throughout the pandemic, health care workers made tremendous personal sacrifices to treat wave after wave of patients in the face of an unprecedented threat. In challenging times, they met the moment, which is the very definition of heroism. Now health care workers are the ones needing help — from members of the public and from policymakers.
Duke Health supports additional efforts to provide federal funding to support hospital-based violence intervention programs and the mental health and resiliency among health care providers.
TELEHEALTH
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Both the federal and state response to the COVID-19 national health emergency has led to an unprecedented expansion of telehealth services and access to telehealth resources. The commitment has continued beyond the PHE's expiration in 2023.
]Medicare PHE-tied telehealth flexibilities have been extended through the end of 2024 (including the authority to permit audio-only services). This also includes the Acute Care Hospital at Home Medicare waiver program.
The House Ways and Means Committee has approved legislation - The Preserving Telehealth, Hospital, and Ambulance Access Act (H.R. 8261) - that would extend for two additional years the current telehealth flexibilities (through 2026) and for five additional years (through 2029) the hospital at home program.
The House Energy and Commerce Committee has approved a similar two-year extension of telehealth flexibilities and five-year extension of the hospital at home program with a modified Telehealth Modernization Act (H.R. 7623).
The House and Senate are expected to work together to pass extension legislation as part of a lame duck session following the November elections.
Status
Existing telehealth policies will continue to be examined by the 118th Congress, including efforts to make many of the current flexibilities permanent.
Duke Health Government Relations is working in partnership with Duke leadership and the Duke Digital Strategy and Telehealth Office to monitor additional telehealth legislation introduced in Congress and ensure that beneficial telehealth policies are strengthened and maintained.
Background
The COVID-19 public health emergency saw an unprecedented expansion of telehealth under Medicare. Many of these policies will remain in effect through at least the end of 2024 with Congress and CMS evaluating permanence.
CMS has updated resources on telehealth access and reimbursement eligibility.
MEDICARE SUPPORT FOR GRADUATE MEDICAL EDUCATION (GME)
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According to the Association of American Medical Colleges, physician demand will grow faster than supply, leading to a projected total physician shortage of between 37,800 and 124,000 physicians by 2034. In 2020, Congress passed for the first time in almost 25 years legislation to provide 1,000 new Medicare-supported GME positions.
The FY 2023 omnibus provided, beginning in 2026, an additional 200 Medicare-funded GME residency positions. At least half of the positions will be dedicated to psychiatry and psychiatry subspecialty residencies. Additionally, at least 10% of positions will be distributed to rural hospitals, hospitals operating above their cap, hospitals in states with new medical schools, and hospitals that serve health professional shortage areas.
On March 29, 2023, the Resident Physician Shortage Reduction Act of 2023 (H.R. 2389) was introduced in the House of Representatives. The legislation would provide 14,000 new Medicare graduate medical education (GME) positions over seven years. In determining which hospitals would receive positions, the Centers for Medicare & Medicaid Services (CMS) would be required to consider the likelihood of a teaching hospital filling positions and would be required to distribute at least 10% of the positions to each of the following categories of hospitals:
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Hospitals in rural or noncontiguous areas.
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Hospitals training over their GME cap.
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Hospitals in states with new medical schools or new branch campuses.
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Hospitals that serve areas designated as Health Professional Shortage Areas, with priority to hospitals affiliated with historically Black medical schools.
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Duke Health Government Relations continues to support lifting the cap on Medicare GME to help address the physician shortage and protecting vital GME and IME payments to teaching hospitals. We look forward to supporting bipartisan efforts and legislation in the 118th Congress to continue to increase Medicare GME residency slots.
Background
Medicare currently has a 23-year old cap on support for training new physicians, which does not reflect current needs in addressing the shortage. In addition, teaching hospitals incur additional costs in training future physicians to treat complex patients using cutting-edge treatments and care (through indirect medical education, or IME).
WORKING IN PARTNERSHIP TO ADDRESS THE BLACK MATERNAL HEALTH CRISIS
According to the CDC, each year in the United States about 700 women die during pregnancy or in the year after. Black women are three times more likely to die from pregnancy-related complications and twice as likely to lose an infant to premature death. The Duke Department of Obstetrics & Gynecology and Duke Health are dedicated to providing excellent care to all of the communities we serve and committed to addressing maternal health disparities.
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While the “Black Maternal Health Momnibus Act” did not pass in the 117th Congress, it was reintroduced as HR3305/S1606 in the 118th Congress. However, there were provisions in the congressionally-passed FY 2023 omnibus bill for policies and funding focused on improving maternal health, including funding for a maternal mental health hotline, grants to support maternal mental health programs, and making permanent the option for states to extend postpartum coverage under Medicaid and CHIP from 60 days to 12 months.
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Duke Health continues to prioritize support for federal policies to improve maternal health and health outcomes. Specifically, Duke Health supports efforts by U.S. Reps. Alma Adams (D-NC) and Lauren Underwood (D-IL), and the Black Maternal Health Caucus, to address the Black maternal health crises through the “Black Maternal Health Momnibus Act,” which was reintroduced in the 118th Congress.
Duke Health coordinated feedback and ideas from the Duke Department of Obstetrics & Gynecology to inform future legislation, and we continue to support legislation that ensures the necessary tools, resources, and policies to support mothers and improve health and health outcomes. Duke Health also supports efforts to advance policies to promote the inclusion of pregnant and lactating individuals in vaccine and therapeutic development.
DRUG PRICING
Background
Access to affordable pharmaceuticals is important to manage health and enable improved health outcomes. The 117th Congress enacted significant legislation aimed at lowering the cost of prescription drugs. Specifically, the Inflation Reduction Act – a roughly $700 billion social spending package that includes health care, climate change and tax provisions -- allows the Medicare program to negotiate drug prices. We expect the 118th Congress will continue to examine proposals that aim to lower the cost of prescription drugs.
The following summary of the Inflation Reduction Act’s healthcare provisions is from the American Hospital Association (AHA).
Key Highlights
The legislation will:
- Extend for three years the expanded eligibility and value of ACA Marketplace subsidies, originally passed in the American Rescue Plan;
- Allow Medicare to negotiate drug prices on a limited set of drugs, including insulin;
- Address climate change through a combination of tax changes and spending subsidies; and
- Reduce the deficit.
Coverage
Extend the Expanded Eligibility for and Value of Health Insurance Marketplace Subsidies. The legislation extended the expanded eligibility for and value of health insurance marketplace subsidies authorized through the American Rescue Plan Act through 2025. The subsidy expansion was authorized through 2022, and approximately three million individuals newly enrolled as a result. Specifically, the American Rescue Plan expanded eligibility for subsidies to individuals above 400% of the federal poverty level (the limit in the ACA) by making eligible anyone for whom the cost of benchmark coverage would exceed 8.5% of income. The American Rescue Plan also lowered the premium percentage at every income level, with the effect of increasing the value of the marketplace subsidies and further reducing the cost of coverage. For individuals with income up to 150% of the federal poverty level, the subsidy amounts result in the availability of plans with zero dollar premiums.
Drug Pricing
The legislation allowed for the first time negotiation between the federal government and pharmaceutical manufacturers to establish prices for a subset of higher cost, sole source drugs covered through Medicare Part B and Part D. This provision will be phased in beginning with 10 Part D drugs only in 2026, 15 Part D drugs only in 2027, 15 Part D and/or Part B drugs in 2028, and 20 Part D and/or Part B drugs in 2029 and beyond. Whether or not the government is limited to negotiating prices for a maximum of 20 drugs in 2029 and years thereafter or the provision is cumulative and therefore could result in upwards of 100 drugs subject to negotiation in later years is not clear. Certain drugs will be excluded from negotiation, including certain orphan drugs, certain low-spend Medicare drugs, plasma-derived biological products and certain small biotech drugs.
The price negotiated between the government and the manufacturer — known as the “Maximum Fair Price” (MFP) — must be lower than a ceiling price established based on a formula in the law. Manufacturers that sell drugs subject to the MFP at a higher amount for patients covered under Medicare Part B or Part D will be subject to civil monetary penalties. Manufacturers that refuse to negotiate with the government will be subject to an excise tax or would otherwise have to drop participation in Medicare and Medicaid. For eligible drugs, manufacturers must offer 340B entities the lower of either the MFP or the 340B discount; however, manufacturers are protected against “duplicate discounts.”
In addition, the legislation made a number of changes in prescription drug coverage and other drug-related policies. Specifically, among other provisions, the legislation will:
- Cap Medicare patients’ out-of-pocket costs in the Part D program at $2,000 per year;
- Cap cost-sharing for insulin products to no more than $35 per month in the Medicare program only;
- Provide additional premium and co-pay assistance on prescription drugs for low-income individuals;
- Institute a new “inflation rebate” under Part B and Part D whereby drug manufacturers that raise prices faster than inflation would be subject to mandatory rebates to the Medicare program;
- Prohibit implementation of the prescription drug rebate rule until at least 2032;
- Provide additional federal financial assistance to stabilize Part D premiums for seniors in Medicare; and
- Provide enhanced coverage for vaccines, including by covering Part D vaccines without cost-sharing obligations for Medicare beneficiaries.
INFRASTRUCTURE & RECONCILIATION
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On August 12, 2022, the House passed the Inflation Reduction Act of 2022, which the Senate approved on August 7 by a vote of 51-50, with Vice President Kamala Harris breaking the tie. The Inflation Reduction Act is a pared-down version of the Build Back Better Act, which previously passed the House but did not gain traction in the Senate.
The $700 billion social spending package includes health care, climate change, and tax provisions and represents the end of a complicated budget reconciliation process for this year. Among other things, the bill will extend Affordable Care Act subsidies through 2025; allow Medicare to negotiate drug prices on a limited set of drugs, including insulin; address climate change through a combination of tax change and spending subsidies; and reduce the deficit.
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The Inflation Reduction Act was signed into law by President Biden in August 2022.
Background
On March 31, 2021, President Biden unveiled details of his $2.3 trillion American Jobs Plan, which sought to modernize much of the nation's “traditional” physical, technological, and workforce infrastructure. The plan included funding for roads, bridges, and ports but also addressed the climate crisis, broadband access, waterways, and investments in research and development. Elements of this plan were incorporated into the bipartisan “traditional” infrastructure package described above.
On April 24, 2021, the Biden administration released the $1.8 trillion American Families Plan, which combined new spending and tax incentives in an effort to expand health care coverage and provide education and child care support. Portions of the plan included permanently extending expanded ACA premium credits to support the purchase of health insurance and phase in the coverage of hearing, vision, and dental benefits for Medicare beneficiaries; a permanent extension of the Children’s Health Insurance Program (CHIP); extending postpartum coverage; investments in nursing education and other workforce programs; inclusion of the Momnibus Act; and capital investments for aging hospitals and laboratories. Elements of this plan were incorporated into the Build Back Better Act “human” infrastructure reconciliation package.
The House of Representatives passed the $1.75 trillion Build Back Better Act (BBBA) “human” infrastructure reconciliation package on November 19, 2021. The BBBA included significant investments in health care priorities, education and childcare, and support for working families and individuals. Following passage by the House, the BBBA did not receive the support of all 50 Democratic Senators. Subsequent negotiations resulted in the pared down Inflation Reduction Act described above.
IMMIGRATION
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The Conrad State 30 and Physician Access Reauthorization Act (S.665) was re-introduced in the Senate in March 2023. The bill would expand the Conrad State 30 program. Senator Thom Tillis (R-NC) is an original co-sponsor. The legislation must be considered by the end of 2024 or reintroduced in the 119th Congress.
Efforts are underway in Congress to develop legislation prioritizing visas and processes to support more international healthcare workers in the United States, but the debate has been complicated by some policymakers unwilling to move on any proposals that do not also address border security issues.
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Duke Health Government Relations is working with our Duke University government relations colleagues, professional associations, partners, and others to advocate on behalf of our international students and their contributions to the medical workforce and research enterprise. We will continue to communicate our concerns with the North Carolina congressional delegation and continue our advocacy with the 118th Congress and Biden Administration.
Background
The Biden administration has suspended or allowed to expire a number of proclamations and orders issued by the Trump administration that limited immigration and visa processing in the United States.
However, one order remains from May 2020. It is a proclamation that would suspend visa processing for certain individuals from China who are seeking to enter the U.S. to pursue graduate studies or conduct research. The proclamation, limited in scope and justified through national security concerns, would suspend F and J visa processing from "any national of the People’s Republic of China who receives funding from or who is currently employed by, studies at, or conducts research at or on behalf of, an entity in China that implements or supports China’s military-civil fusion (MCF) strategy.”
Rulemaking
The Biden administration has formally rescinded the Trump administration's changes to the public charge rule.
SURPRISE BILLING
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wThe Biden administration is considering further adjustments to the federal independent dispute resolution process following several court rulings and a temporary closure of the IDR portal in 2023. The IDR portal resumed considering out of network disputes between providers and insurers in the spring of 2024.
The federal ban on surprise medical billing established by the No Surprises Act (NSA) officially went into effect on January 1, 2022. In recognition of the complex new requirements, the Biden administration is offering enforcement discretion and flexibilities on certain rules governing new good faith estimates for uninsured or self-pay patients until 2023.
The Biden administration released a final rule on the No Surprises Act on August 19, 2022.
The final rule takes into account a federal district court decision in February 2022 that stated the original interim final rule on the federal IDR process was inconsistent with congressional intent on the factors required for evaluating and determining the qualifying payment amount.
Subsequent challenges
The Centers for Medicare and Medicaid Services (CMS) has posted (and will regularly update) resources on the new law:
Status
Duke Health supports resolving surprise medical bills for patients, as well as an independent dispute resolution (IDR) process created by the NSA to settle billing issues between providers and payers.
Duke Health is closely monitoring further implementation of the NSA.
Background
After two years of bipartisan negotiation, Congress passed a broad COVID-19 relief and FY 2021 omnibus spending package in December 2020 that included language to address surprise medical billing. The provision established a baseball-style arbitration process to settle out of network billing disputes between providers and payers.
In 2021, The Department of Health and Human Services, the Department of Labor, and the Department of the Treasury issues rules to implement the No Surprises Act language passed by the omnibus.
- The tri-agencies released the part I interim final rule (IFR) on July 1, 2021. The rules establishes the broad parameters and definitions of the No Surprises Act and sets notice and price transparency policies.
- A notice of proposed rulemaking was issued September 10, 2021 to clarify data reporting requirements for air ambulances.
- The part II IFR was released on September 30, 2021. The IFR includes more information about the new federal independent dispute resolution process to settle out of network disputes between providers and payers.
SICKLE CELL DISEASE
Sickle Cell Disease (SCD) is a devastating and painful disease impacting individuals and families in communities across the United States. According to the Centers for Disease Control and Prevention (CDC), it is estimated that SCD affects about 100,000 Americans, with a disproportionate impact on racial and ethnic minorities. SCD is not only painful, but those who suffer from it are more susceptible to other infections and complications which result in a severely shortened lifespan, frequently in the mid 40’s vs. 70-80’s compared with the US population.
Latest News
In FY 2021, Congress supported a separate budget line for the SCD surveillance program within the National Center for Birth Defects and Developmental Disabilities’ Blood Disorder Division at the CDC. For FY 2022, Duke Health has requested $14.3 million in federal appropriations for the SCD Data Collection Program at the CDC through this separate budget line.
Funding would be used to support current grantees in nine states, which includes the NC Sickle Cell Data Collection Program, a close partnership between Duke University and the NC Department of Health and Human Services. Funding would also be used to expand surveillance to a total of 25 states.
Status
Managing SCD is a life-long struggle. Researchers at the Duke University School of Nursing (DUSON) and the Duke University School of Medicine (DUSOM) are working diligently to improve the quality of life, quality of health services provided, and clinical outcomes for both adults and children with SCD in North Carolina and throughout the United States.
DUSOM’s Sickle Cell Center provides medical services, comprehensive care, and acute management for over 850 children and adults in the Sickle Cell Day Hospital, in addition to basic and clinical research, screening and testing, social services, educational services, and community outreach. Clinics are located in Durham, Raleigh, and Fayetteville, and telehealth visits are available to patients throughout the state. DUSON conducts research to help understand the prevalence and impact of SCD and on how to better treat and care for patients.
Background
Federal funding is critical to Duke’s important SCD work. Funding for this research is supported by the CDC, Health Resources and Services Administration (HRSA), the National Institutes of Health (NIH), and the Agency for Healthcare Research and Quality (AHRQ).