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.
View our Legislation Tracking Sheet for a quick overview of some of the bills we tracked during the 117th Congress. For any of the bills that did not become law, we'll monitor whether they are reintroduced in the new Congress.
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.
Latest News
Congress passed a consolidated appropriations package (omnibus) in December 2022 to fund the federal government for the remainder of Fiscal Year (FY) 2023, which runs through September 30, 2023.
In addition to funding the government, the omnibus also addressed a number of healthcare policy issues, including Medicare reimbursement, telehealth, mental and behavioral health, an outside compensation fix for VA researchers, and GME.
Highlights include;
- $47.5 billion for NIH, an increase of $2.5 billion (5.6%) above the current level, as well as $1.5 billion for the new Advanced Research Projects Agency for Health (ARPA-H).
- $52 million for the 12 Regional Biocontainment Labs, including at Duke, to assist national, state, and local public health efforts in the event of a bioterrorism or infectious disease emergency.
- $39 billion for the Defense Health Program, a $3 billion increase, including funding for medical research programs.
- $916 million for VA Medical and Prosthetic Research, a $34 million increase above the current level.
- $880 million for Title VII health professions programs and Title VIII Nursing Workforce Development programs at the Health Resources and Services Administration (HRSA), an increase of $80.6 million above the current level.
A summary of key health-related funding provisions can be found here.
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.
Status
The 118th Congress will turn its public attention to the FY 2024 budget and appropriations process following the expected release of the president's budget in February.
Background
President Biden is expected to release his administration's budget request to Congress in February. 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.
FEDERAL RESPONSE TO COVID-19
Latest News
Effective on January 11, 2023, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra renewed the declaration of the COVID-19 national public health emergency declaration (PHE). The national declaration unlocks key flexibilities at the federal, state, and local levels to support ongoing efforts to respond to the virus, including the Centers for Medicare and Medicaid Services (CMS) waiver authority to continue flexibilities for telehealth services. The most recent renewal is consistent with the Biden administration’s promise to provide at least a 60-day notice before winding down the PHE, and marks the twelfth time since the initial declaration was made in March of 2020. The renewed declaration will last for 90 days through April 11, 2023.
Status
Duke Health Government Relations will continue to advocate for priorities that strengthen Duke’s response to COVID-19 and supports communities in Durham, and throughout North Carolina, strengthening funding for biomedical research, including for the NIH and Departments of Defense and Veterans Affairs medical research. In addition, we will continue to promote funding priorities specific to the School of Medicine and School of Nursing.
Background
On December 21, 2020, Congress approved a combined spending package that included $1.4 trillion in discretionary spending to fund the federal government through September 30, 2021, and $900 billion in COVID relief and stimulus. The COVID-19 relief portion of the bill provided $1.25 billion to the National Institutes of Health (NIH) for research and clinical trials related to the long-term effects of COVID-19 ($1.15 billion), as well as continuing support for Rapid Acceleration of Diagnostics ($100 million for RADx). In addition, it provided $3 billion for the Provider Relief Fund and included important language on reporting requirements and how providers may calculate lost revenues. Among many other things, the bill also eliminated the $4 billion in Medicaid DSH cuts scheduled to occur in FY 2021 and created 1,000 new Medicare Graduate Medical Education slots for the first time in 25 years.
To address the federal, state, and local response to the COVID-19 virus, Congress has now approved six emergency spending packages totaling approximately $5.4 trillion. Funding has been allocated to mitigate the impact of COVID-19 on communities, healthcare providers, and individuals throughout the country. Among other provisions, the packages have included:
- Additional funding for the NIH, Centers for Disease Control and Prevention (CDC), Public Health and Social Services Emergency Fund, and Food and Drug Administration (FDA);
- Funding for state and local governments, with $8 billion set aside for local governments, in a coronavirus relief fund;
- Small business assistance funding;
- Additional funding for hospitals;
- Eliminating patient cost-sharing for COVID-19 testing and related services, establishing an emergency paid leave program, and expanding unemployment and nutrition assistance
INFRASTRUCTURE & RECONCILIATION
Latest News
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.
Status
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 FY 2023 omnibus package included a one-year reauthorization of the Conrad 30 State Program, which allows international doctors on J-1 visas to remain in the U.S. upon completing their residencies under the condition that they practice in medically underserved areas, including academic medical centers.
The Biden administration's immigration reform proposal seeks to provide more expedited pathways to citizenship for undocumented individuals living in the U.S., implement stronger worker protections, recapture and repurpose unused visas, improve visa processing and immigration court backlogs, address migration, and responsibly secure borders.
President Biden has also issued a series of immigration-related executive orders, including policy statements to reaffirm a commitment to DACA, reverse the Muslim-country travel ban, stand down aggressive immigration enforcement practices, and to review the public charge rule.
The 117th Congress was otherwise unable to come to an agreement on immigration reform legislation, and discussions are expected to continue in the 118th Congress.
Status
During the COVID-19 national health emergency, Duke Health Government Relations is closely monitoring immigration and visa-related issues impacting our health system's ability to maintain a strong and well-trained medical workforce. The NC Congressional delegation is aware of the challenges presented by current J-1 and H1-B visa regulations with respect to bolstering our frontline response to COVID-19, and efforts are underway to urge the United States Citizenship and Immigration Services (USCIS) Office to provide additional flexibilities.
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 117th 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 effectively blocked a Trump administration interim final rule that attempted to make significant changes and potentially harmful to the "prevailing wage determinations" for certain highly-skilled H-1B visa holders, including those in STEM, research, and medical occupations.
The Biden administration indicated that it may revisit the prevailing wage issue in the future.
The Biden administration also formally rescinded the Trump administration's changes to the public charge rule.
TELEHEALTH
Latest News
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 Centers for Medicare and Medicaid Services (CMS), through emergency waiver authority, have provided numerous telehealth flexibilities that will remain in place through the end of the public health emergency (PHE).
The FY 2023 omnibus legislation passed in December 2022 extends current Medicare PHE-tied telehealth flexibilities through the end of 2024 (including the authority to permit audio-only services). The omnibus also included a two-year extension of the Acute Care Hospital at Home Medicare waiver program.
Status
With the COVID-19 pandemic extending into 2023, 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 Telehealth Office to monitor additional telehealth legislation introduced in Congress and ensure that beneficial telehealth policies are strengthened and maintained.
Background
The federal government, through HHS and CMS, has issued a number of temporary waivers and orders, which have relaxed requirements for the use of telehealth under Medicare and Medicaid to assist providers on the frontlines of the public health emergency and allow for the continuation of care for millions of patients.
Resources
- The American Hospital Association has developed a resource document highlighting which of the telehealth flexibilities may be indefinitely extended by CMS and which will require a congressional response to be made permanent.
- The American Telemedicine Association, which is among the professional organizations and partners the Duke Health Government Relations team consults on telehealth issues, has outlined which of the expanded telehealth options it would like to see be made permanent beyond the public health emergency.
MEDICARE SUPPORT FOR GRADUATE MEDICAL EDUCATION (GME)
Latest News
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.
Status
GME-related legislation not addressed in the 117th Congress will need to be re-introduced in the new Congress.
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).
SURPRISE BILLING
Latest News
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.
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.
A final rule (as noted above) on the federal IDR process was issued in August 2022
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.
PROTECTING AND SUPPORTING THE HEALTHCARE WORKFORCE
Latest News
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. This bill would have provided 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 have also authorized 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 appreciated the support for the SAVE Act from members of the North Carolina Delegation including Rep. Deborah Ross (D-NC-02), Rep. Alma Adams (D-NC-12), and Rep. David Rouzer (R-NC-07). Duke Health supports the reintroduction of the SAVE Act in the 118th Congress.
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 Executive Vice President and Chief Operating 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.
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.
Latest News
The “Black Maternal Health Momnibus Act” did not pass in the 117th 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.
Status
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 we anticipate will be 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.
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).