March 2, 2023
overview
All eyes are on the annual appropriations and National Defense Authorization Act process that is gearing up for President Biden’s FY2024 budget request to be unveiled on March 9. Along side the September 30 deadline to complete appropriations bills as the new fiscal year commences on October 1, there are expiring authorizations. For example, the Federal Aviation Administration (FAA) and the farm bills all need to be crafted and passed over the next seven months. Congress also wants to push through bipartisan legislation on kids’ online privacy, energy permitting, marijuana banking, more fentanyl and opioid support, among other issues. G2G has been on the Hill and at events with Members of Congress as things are back to normal in this “post-COVID” world.
BUDGET & APPROPRIATIONS
Several proposals are surfacing to address the looming $31.4 trillion debt limit, which we will likely reach late summer if Congress and President Biden cannot reach a deal. In addition, Congress is gearing up to respond to the president’s fiscal 2024 budget proposal that is expected March 9. Many Members have set deadlines for appropriations submissions that are hitting throughout late February into late March. That includes House Community Project Funding and Senate Congressionally Directed Spending requests. In an interesting twist, House Appropriations Chair Kay Granger (R-TX) just released new rules for CPF requests—none allowed within the very popular LHHS bill as well as Defense, State, and Financial Services bills. Also, any such project must have a “federal nexus.” The new rules will likely complicate negotiations with senators on an eventual omnibus spending package, as the Democrat-led Senate is not following suit.
Beyond appropriations, the House GOP leaders have focused on investigating the Biden administration, while Senate Democrats keeping pushing through confirmations of the president’s executive and judicial nominees. Also, Republicans in both chambers are pushing for votes to overturn recent regulations under procedures requiring only a simple majority in the Senate, which could potentially set up Biden’s first veto.
HEALTH
COVID & TELEHEALTH
As the May 11 ending of the COVID-19 public health emergency approaches, many are concerned about the millions of people enrolled in Medicaid who will be dropped and the removal of free over-the-counter COVID tests for Medicare beneficiaries. It also impacts the #1 killer of Americans: heart disease. Under the COVID emergency, more people, especially seniors, were super motivated to take steps to avoid hospital admissions and could participate in virtual services to get supervised exercise and counseling, which contributed toward better heart health and heart attack prevention. But Medicare coverage for certain telehealth services such as cardiac rehabilitation will end, along with the White House COVID emergency declaration.
The silver lining of COVID is the creative way in which patients and providers shifted care to telemedicine and health innovators made telemedicine more user friendly, however without legislative fixes, some of those gains will be lost in May. While Congress late last year extended many of these temporary Medicare changes through the end of 2024 as part of the omnibus spending bill, namely giving people in rural areas access to telehealth services, it did not include cardiac rehab in the usual last-minute legislative rush to get it passed. As a result, hospitals now fear they’ll have to stop offering this virtually.
COVID INVESTIGATIONS
Senator John Hoeven (R-ND) has called on Health and Human Services Secretary Xavier Becerra to end COVID-19 mandates that he said are hurting rural hospitals and care facilities. Meanwhile in the House, the Select Subcommittee on the Coronavirus Pandemic is investigating how possible side effects are being studied, the regulatory process of authorizing and approving the vaccines, and why the vaccines were mandated. One goal of the committee is making sure the U.S. is prepared for future pandemics.
FENTANYL CRISIS & RESEARCH PRIORITIES
Fentanyl, a synthetic opioid that’s anywhere between 50 to 100 times stronger than morphine, is fueling the current wave of the opioid crisis, particularly when mixed with other drugs such as methamphetamine or cocaine. The rise in opioid overdose deaths dates back to 2001 but skyrocketed in the period of 2019 to 2023, according to the CDC. More recently, a report published February 21 by Millennium Health found positive drug tests for fentanyl jumped 146% between 2019 and 2022. Out of those positive tests, more than 83% of them also contained additional drugs, including heroin, prescription opioids, methamphetamine, or cocaine. The record number of Americans dying from a mix of drugs laced with fentanyl has caught Congress’ attention with recent hearings and moving testimony shared by those who lost loved ones. It is also driving NIH-backed research into medications that can eliminate multiple substances from the body.
The National Institute on Drug Abuse (NIDA) is prioritizing research to counteract overdoses from more than one drug. One promising medication could start initial safety testing as soon as June or July. These drug combinations make the drug overdose response “much harder and much more complex,” said NIDA Director Nora D. Volkow.
Therefore, expanding the range of treatment options for substance use disorders is a key focus area. That work includes research into fentanyl vaccines and monoclonal antibodies that can can bind to methamphetamine and trap it before the drug enters the brain, heart tissue, and other organs.
Meanwhile state and federal officials, including at the FDA, have worked to make the opioid reversal medication naloxone more readily available, even voting to make naloxone available without a prescription. But while naloxone is safe and effective on opioids, it is not a panacea as while it works very quickly to counteract an opioid overdose, it doesn’t work on all drug combinations and the effect doesn’t always last, particularly if there’s a lot of fentanyl in the body.
NIDA is also funding research into devices that could restore breathing, a user-friendly device to counteract cardiac arrhythmias from drug overdoses, and a device that could deliver naloxone automatically like an insulin pump for diabetes. But the challenge is whether someone with an opioid use disorder who is seeking illicit fentanyl will even wear a device that will monitor them continuously.
DIAGNOSTICS AT HOME
Increasing access and opening the door to a slew of similar testing options, on February 24 the FDA issued an emergency use authorization (EUA) to Lucira’s at-home, over-the-counter combination COVID-19 and flu test, the first combination test to be cleared for OTC sale. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs,” FDA Commissioner Shuren said. The agency says it will continue to use its authorities to increase the number of at-home tests available, especially those used to detect highly contagious respiratory viruses.
With the latest authorization, the test can now be purchased without a prescription and used with samples that have been self-collected by people ages 14 and older or by an adult for people ages 2 and older. After collecting the nasal swab sample, users should swirl the sample swab in a vial that is placed in the test unit. After 30 minutes or less, the test unit will display results indicating whether a person is positive or negative for flu A, flu B and COVID-19. If necessary for patient management, negative results for COVID-19 and flu B should be confirmed with an authorized or cleared molecular test performed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab that meets requirements to perform high or moderate complexity tests, according to the FDA.
Meanwhile state and federal officials, including at the FDA, have worked to make the opioid reversal medication naloxone more readily available, even voting to make naloxone available without a prescription. But while naloxone is safe and effective on opioids, it is not a panacea as while it works very quickly to counteract an opioid overdose, it doesn’t work on all drug combinations and the effect doesn’t always last, particularly if there’s a lot of fentanyl in the body.
NIDA is also funding research into devices that could restore breathing, a user-friendly device to counteract cardiac arrhythmias from drug overdoses, and a device that could deliver naloxone automatically like an insulin pump for diabetes. But the challenge is whether someone with an opioid use disorder who is seeking illicit fentanyl will even wear a device that will monitor them continuously.
G2G's Call to Action Alerts!
NEW SMALL BUSINESS TAX
| Protect Entrepreneurship & Scientific Innovation - New Tax Applies to March 15 Deadline
The 2017 Tax Cuts and Jobs Act (TCJA) requires companies that conduct scientific research to capitalize these expenditures, which means they can only deduct 10% of their “R&E” (Research & Experimentation) expenses for the 2022 tax year. Companies will have to pay taxes on 90% of the funds used to support their “R&E” (similar to “R&D”) expenses in 2022, whereas in prior years, the expenses could have directly offset the income, resulting in no tax liability. For LLCs, the tax passes through to the owner(s), who then have a substantial tax burden on hundreds of thousand dollars of unexpected “income”, without any means of paying this tax. This could bankrupt businesses providing critical research for patients and society. See article with further information on this tax. Please co-sign this letter and share with other businesses impacted by this tax. Please respond by March 3! |
MENOPAUSE CO-PAYS
End Menopause Co-Pays - Access to Care Impacting Employment, Productivity, Health, Well-Being and their Families & Communities is Limited for Too Many Women
| Menopause is experienced by all women who reach 40s-50s yet stigma, little information, lack of investment into research and innovation, and co-pays that block access to and utilization of effective treatments for its symptoms persist. This impacts not just women, but the national economy as some women drop out of the workforce or step back just at their professional peak due to severity of symptoms.
Join us in advocating for Congress to provide this access by eliminating co-pays and deductibles related to menopause treatments and doctor visits by co-signing this letter. We plan to send the same letter to the House and Senate health committee leaders for Ways & Means and Senate Finance Committee. Please circulate to help raise awareness and encourage others to co-sign. |
Please co-sign by March 10! |