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Monthly Legislative Newsletter: January 2023
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Congressional State of Play

After 15 votes over the course of 4 days, the House of Representatives finally has a Speaker of the House. Ultimately, Rep. Kevin McCarthy (R-CA) was elected along party lines after reaching a deal with the remaining House Freedom Caucus members on a Rules Package that would dictate how business in the House is conducted. Now that the Speaker has been elected and the Rules Package likely to pass on the evening of January 9, 2023, Congress can begin its regularly scheduled and necessary work. Committee assignments will be released over the next week, and we expect hearings to commence soon after. As discussed in previous newsletters, we expect the Republican House to focus on oversight of the Biden administration through hearings on topics such as the Inflation Reduction Act, border security and immigration, and the business dealings of Hunter Biden.

The Democrat controlled Senate is expected to resume normal work in the coming weeks with Committee assignments being released the week of January 9, 2023. Once Committee assignments are made, the Senate will begin conducting hearings and taking other legislative action on the floor. Due to the split Congress, we can expect the Senate to largely focus on confirming Biden administration nominations and judicial appointments.

However, there are a number of issues that will need to be addressed despite the split. Congress will have to find some way to increase the debt ceiling as well as fund the government for Fiscal Year 2024. This will likely prove to be no small task as many Republicans have committed to fighting spending increases and opposition to increasing the debt ceiling.

Fiscal Year 2023 Appropriations Wins

Below please find the key cancer related provisions in the FY23 Omnibus. Potential provisions such as the VALID Act, Childhood Cancer STAR Act Reauthorization, and Gabriella Miller Kids First Reauthorization were not included in the final package. Additional analysis is linked at the bottom of each section where available. However, the Childhood Cancer STAR Act was reauthorized by unanimous consent before the end of the year in both the House and Senate.

FY23 Omnibus Bill Text

LHHS Explanatory Statement

LHHS Summary

Defense Explanatory Statement

Defense Summary

Peer-Reviewed Cancer Research Program

The agreement provides $130.000,000 for the peer-reviewed cancer research program to research cancers not addressed in the breast. pancreatic. prostate. ovarian. kidney, lung, melanoma, and rare cancer research programs.

The funds provided in the peer-reviewed cancer research program are directed to be used to conduct research in the following areas: bladder cancer: blood cancers; brain cancer; colorectal cancer; endometrial cancer; esophageal cancer; germ cell cancers; head and neck cancer: liver cancer; lymphoma; mesothelioma; metastatic cancers; myeloma; neuroblastoma; pediatric brain tumors; pediatric, adolescent, and young adult cancers; sarcoma; stomach cancer; thyroid cancer; and Von Hippel-Lindau syndrome malignancies (excluding cancers of the kidney and pancreas).

The peer-reviewed cancer research program shall be used only for the purposes listed above. The inclusion of the individual rare cancer research program shall not prohibit the peer-reviewed cancer research program from funding the above-mentioned cancers or cancer subtypes that may be rare by definition. The report directed under this heading in House Report 117-88 is still required to be provided not later than 12 months after the enactment of this Act.

Glioblastoma

Glioblastoma (GBM).--Glioblastoma is a cancer with less than a five percent five-year relative survival rate, and the average survival time from diagnosis has improved by only six months over the last 30 years. To date, there have only been five drugs and one medical device approved by the FDA for the treatment of GBM. With prior Congressional investment in NCI programs, glioblastomas have been molecularly characterized, resulting in a new and promising understanding of these tumors, including the identification of potential clinical strategies and agents, trial designs, and imaging and pathology technologies.

The Committee commends NCI for its establishment and initial implementation of the GBM Therapeutics Network (GTN). The GTN's cross-cutting teams' capabilities to conduct pre-clinical studies and early-phase clinical trials enables the careful evaluation of potential treatments, including small molecule drugs, immunotherapies, radiation, and devices. The overall goal of the GTN is advancing progress towards future cures and improved quality of life for GBM patients.

Given this initial progress, the Committee urges NCI to continue to enhance and accelerate its implementation of the GTN and continue to fund to the full extent necessary so that this program can rapidly launch clinical trials that speed access to promising qualified treatments to patients consistent with NCI's Glioblastoma Working Group recommendations in 2019.

Advanced Research Projects Agency – Health

The agreement includes $1,500,000,000 for ARPA-H. The agreement strongly encourages HHS to collaborate with the Defense Advanced Research Projects Agency (DARPA) to develop the foundational policies, procedures, and staff training for ARPA-H employees. The agreement believes ARPA-H will require a very different culture and mission than NIH's other 27 Institutes and Centers. To foster the development of an entrepreneurial culture, the agreement expects ARP A-H to be physically located away from the main NIH campus. The agreement directs NIH to brief the Committees no later than 30 days prior to conducting the location search on its criteria and the Committees should be notified of the decision no less than 5 days prior to a location being announced publicly. While the NIH workforce is composed of dedicated, talented, and frequently brilliant scientists, recruitment from the existing NIH workforce should be avoided. Instead, the agreement recommends that ARP A-H consider recruiting from industry, academia, and think tanks, as well as from proven advanced research project organizations. The agreement directs ARPA-H to provide quarterly briefings to the Committees on its establishment process, hiring, and scientific priorities and progress. These briefings should specifically address how its activities may advance biomedical research and development and the mission to create breakthrough health technologies, as well as how to balance long-term scientific challenges with short-term research goals.

See Politico Pro Analysis HERE.

National Institutes of Health and National Cancer Institute

The agreement provides $47,459,000,000 for NIH, including $1,085,000,000 from the 2 pt Century Cures Act (P.L. I I 4-255, Cures Act), an increase of $2,500,000,000, or 5.6 percent, above the fiscal year 2022 enacted level. The agreement provides a funding increase of no less than 3.8 percent above the fiscal year 2022 enacted level to every Institute and Center (IC). Per the Cures Act, $216,000,000 is transferred to the National Cancer Institute (NCI) for cancer research; $225,000,000 to the National Institute of Neurological Disorders and Stroke (NINOS) and $225,000,000 to the National Institute on Mental Health (NIMH) for the BRAIN Initiative; and $419,000,000 to the Office of the Director (OD) for the All of Us precision medicine initiative.

The agreement directs NIH to include updates on the following research, projects, and programs in the fiscal year 2024 Congressional Justification: metastatic breast cancer; NCI's plans to update the Surveillance, Epidemiology, and End Results Registry; pulmonary fibrosis; cellular immunity; and opportunities to enhance childhood cancer research efforts, including coordinating efforts already underway through the Trans-NIH Pediatric Research Consortium.

Clinical Trial Diversity

Clinical Trial Diversity.--The Committee recognizes NIH's efforts to increase meaningful participation across the lifespan of ethnic and racial minority populations and underrepresented communities in clinical trials. The Committee encourages NIH to continue improving clinical research diversity, equity, inclusion, and accessibility by engaging in proactive outreach efforts to people including women and racial and ethnic minority groups, underrepresented communities, and health care organizations serving these populations, to improve awareness of clinical research, including trials, and understanding of how people can participate. The Committee requests an update on these activities in the fiscal year 2024 Congressional Justification.

Cancer Moonshot

Cancer Moonshot.- The agreement directs NCI to provide a report to the Committees within I 80 days of enactment of this Act describing the steps it will take to advance efforts to develop a robust pipeline of new treatments for recalcitrant cancers, defined in the Recalcitrant Cancer Research Act of 2012 (P.L. I I 2- 239) as those with a five-year survival rate below 50 percent.

Childhood Cancer Data Initiative

Childhood Cancer Data Initiative (CCDI).- The agreement includes no less than $50,000,000 for the CCDI, including no less than $750,000 to continue to support enhancement of the CCDI Molecular Characterization Initiative.

Childhood Cancer STAR Act

Childhood Cancer STAR Act.-The agreement includes no less than $30,000,000 for continued implementation of sections of the Childhood Cancer Survivorship, Treatment, Access, and Research (ST AR) Act (P.L. 115-180). The agreement directs NIH to provide an update in the fiscal year 2024 Congressional Justification on opportunities to enhance childhood cancer research efforts and the actions NCI has taken to ensure pediatric cancer expertise is included on all panels, as appropriate.

Gabriella Miller Kids First Research Act

$12,600,000 is appropriated to the Common Fund from the 10-year Pediatric Research Initiative Fund described in section 9008 of the Internal Revenue Code of 10 1986 (26 U.S.C. 9008), for the purpose of carrying out section 402(b)(7)(B)(ii) of the PHS Act (relating to pediatric research), as authorized in the Gabriella Miller Kids First Research Act.

Telehealth

Telehealth Centers of Excellence (COE).- The agreement includes $8,500,000 for the Telehealth COE awarded sites.

Provider Bridge.- The agreement includes $500,000 to continue the development of the Provider Bridge as part of the Li censure Portability Grant Program.

The omnibus continues Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities for an additional two years, through December 31, 2024.

Accelerated Approval

The bill would allow the FDA to set parameters — such as enrollment goals, milestones and a target completion date — for post-approval studies and institute an expedited process to rescind an accelerated approval while giving the drug sponsor an opportunity to appeal.

It would specify that the FDA may require post-approval studies before approval or within a certain time frame after approval and would require the agency to explain instances in which it doesn't mandate such a study.

The measure would require manufacturers to submit progress reports on their post-approval studies every six months until they're completed and would make failure to file them or to conduct any mandated post-approval studies enforceable offenses.

The legislation also would require establishment of a coordinating council within the FDA to ensure consistent use of the accelerated approval pathway agency wide.

See Politico analysis HERE.

Deadliest Cancers

Deadliest Cancers.-The agreement directs NIH to identify the greatest obstacles and most promising research opportunities to advance progress against each of the deadliest cancers in the fiscal year 2024 Congressional Justification.

Cancer

Cancer.- The agreement supports the Cancer Moonshot by providing an increase for every CDC Cancer Program. In addition to skin cancer discussed separately under this account, the agreement includes an increase for Breast and Cervical Cancer for the activities included in House Report 117-403, as well as increases for Breast Cancer Awareness for Young Women, the National Program of Cancer Registries, colorectal cancer, the National Comprehensive Cancer Control Program, Johanna's Law, ovarian cancer, prostate cancer, and the Cancer Survivorship Resource Center.

Breast and Cervical Cancer.................................... 235,500,000

Breast Cancer Awareness for Young Women. ..... 6,960,000

Cancer Registries.................................................... 53,440,000

Colorectal Cancer................................................... 44,294,000

Comprehensive Cancer........................................... 22,425,000

Johanna's Law........................................................ 11,500,000

Ovarian Cancer...................................................... 14,500,000

Prostate Cancer...................................................... 15,205,000

Skin Cancer............................................................ 5,000,000

Cancer Survivorship Resource Center................... 725,000

Telehealth Update

As is detailed above, the FY23 Omnibus package included a two-year extension of telehealth flexibilities originally enacted during the COVID-19 pandemic. The emergency provisions were set to expire five months after the COVID-19 public health emergency ends. However, the provision in the Omnibus ensures that the flexibilities will be available for two additional years with the goal of this being enough time for the Biden administration to determine which of the pandemic flexibilities should be made permanent.

Immigration Policy Update

On January 5, 2023, the Biden administration released a new immigration plan that would accept 30,000 migrants a month from Cuba, Haiti, and Nicaragua. The plan is modeled on a similar plan that was designed and implemented for Venezuelans and Ukrainians, that “combines safe, orderly, and lawful pathways to the United States, including authorization to work, with significant consequences for those who fail to use those pathways.” The program will be implemented using the Title 42 authority to turn away migrants at the U.S.-Mexico border who do not qualify. Further, migrants who cross into Panama or Mexico illegally, will be ineligible for the program. This is an attempt by the Biden administration to discourage migrants from taking the dangerous illegal journey.