Policy Updates: Hill Happenings and Administration Activities
On November 14, Congress approved a second continuing resolution (CR) (H.R.6363) that extends fiscal year 2023 (FY2023) funding and averted a government shutdown. President Biden signed the CR into law on November 17, officially extending funding for health programs in a “laddered” timeline: some federal agencies and programs face a January 19 funding deadline, but larger agencies, including those funded through the Labor, Health and Human Services, Education, and Related Agencies (LHHS) bill, will face a February 2 deadline.
With Congress back in session following the Thanksgiving recess, lawmakers are working to build a bipartisan agreement on FY2024 topline spending numbers. Democrats insist that topline spending levels were already negotiated during the June 2023 debt ceiling compromise, but some Republicans are calling for deeper spending cuts, including the elimination of key HIV prevention programs like Ending the HIV Epidemic Initiative. Additionally, Speaker Johnson (R-LA-04) suggested the possibility of a full-year CR as a backup plan, which was rebuked as a non-starter by the Senate Appropriations Chair, Senator Patty Murray (D-WA). However, in a Dear Colleague Letter sent December 7, Speaker Johnson clarified his goal of adhering to the topline spending agreement and passing a bona fide FY2024 spending package by the dates established in the current CR.
NASTAD will continue to monitor the congressional appropriations process and advocate for the highest possible funding for HIV, hepatitis, and drug user health programs.
Senate to Markup SUPPORT, Modernizing Opioid Treatment Access Act
On December 12, the Senate Health, Education, and Pensions (HELP) Committee will markup two bipartisan bills that would address the opioid crisis: the SUPPORT for Patients and Communities Reauthorization Act (S. 3393) and the Modernizing Opioid Treatment Access Act (M-OTAA) (S. 644). The original SUPPORT Act (H.R.6), passed in 2018, created a range of programs to combat the opioid crisis and included policy reforms, such as expanding the types of providers who can prescribe medications for opioid use disorder (MOUD). Notably, the reauthorization package would permanently require Medicaid programs to cover all FDA-approved MOUD. M-OTAA would expand access to MOUD by authorizing physicians licensed in addiction medicine and psychiatry to prescribe methadone in non-opioid treatment program (OTP) settings and dispense methadone in community pharmacies.
Congress Passes Bipartisan Bill to Boost Xylazine, Fentanyl Research
On December 4, the House of Representatives passed the Senate-approved TRANQ Research Act of 2023 (H.R. 1734). The TRANQ Research Act would direct the National Institute of Standards and Technology (NIST), housed under the US Department of Commerce, to support research that improves national capacity to detect and handle xylazine, a veterinary sedative increasingly found in the illicit opioid supply that is linked to opioid overdose deaths and can cause severe wounds. In April of 2023, the Biden-Harris Administration declared opioids contaminated with fentanyl and xylazine as an emerging threat. The TRANQ Research Act would also direct NIST to build capacity for the detection of novel synthetic opioids and psychoactive drugs.
White House, CDC Observe World AIDS Day
On December 1, the White House and Centers for Disease Control and Prevention (CDC) observed World AIDS Day, a global event to raise awareness of HIV and sustain commitments to improving the lives of PLWH and end the HIV epidemic. President Biden issued a Proclamation on November 30 highlighting the Administration’s goal of eliminating the public health threat of HIV worldwide by 2030 and the work accomplished under the President’s Emergency Plan for AIDS Relief (PEPFAR), the nation’s global HIV prevention and treatment program. However, future funding for global HIV programming is uncertain after House Republicans targeted PEPFAR funding during appropriations discussions, claiming that PEPFAR funds were used to support abortion access and LGBTQ programming abroad. Click here to read a White House fact sheet highlighting the Administration’s efforts to end HIV and read statements from Harold Phillips, Director of the White House Office of National AIDS Policy, and ADM Rachel Levine, Department of Health and Human Services Assistant Secretary for Health.
HRSA Releases 2022 RWHAP Client-Level Data Report
On December 1, the Health Resources and Services Administration (HRSA) released the 2022 Ryan White HIV/AIDS Program (RWHAP) Client-Level Data Report. The report data show that RWHAP participants achieve and sustain viral suppression at a greater rate than the national average, with nine out of ten RWHAP clients achieving viral suppression. Despite its success, RWHAP funding was the subject of right-wing attacks in the FY2024 House LHHS appropriations hearing, including a proposal to eliminate funding for the Ending the HIV Epidemic Initiative and RWHAP Part F programming, which funds dental care for PLWH.
DOJ Investigation Finds that TN Violated the ADA by Discriminating Against PLWH
On December 1, the Department of Justice (DOJ) announced its finding that the State of Tennessee, including its Bureau of Investigation (TBI) and the Shelby County District Attorney’s Office (SCDAO), violated the Americans with Disabilities Act (ADA) by enforcing the state’s aggravated prostitution statute against PLWH. The statute subjected PLWH to harsher criminal penalties for prostitution charges due merely to the fact that they were HIV positive, escalating a misdemeanor charge to a felony. The DOJ directed the state of Tennessee and the Shelby County District Attorney General to cease enforcement of the rule, amend its policies to comply with ADA non-discrimination protections, and remediate harms to affected individuals, such as reimbursement of court fees, suspension of sentences for aggravated prostitution, and expungement of data from the Tennessee Sex Offender Registry.
HRSA Office of Pharmacy Affairs Director Departs Role
On December 2, U.S. Public Health Service Lieutenant Commander Emeka Egwim, PharmD, RPh, departed his role as the Director of the of HRSA Office of Pharmacy Affairs (OPA) for a new position in the HHS Office of the Assistant Secretary for Health. Egwim joined OPA in February of 2022, which oversees the 340B discount drug pricing program, and became the first Black leader of the HRSA division. Prior to OPA, Egwim was a Senior Policy Analyst in HRSA’s HIV/AIDS Bureau and has worked at the Centers for Medicare & Medicaid Services (CMS) Medicaid Drug Rebate Program. Chantelle Britton will serve as Acting Director of OPA.
Biden-Harris Administration Release Inaugural SDOH Playbook
On November 21, the White House and the U.S. Department of Health and Human Services (HHS) and CMS announced the release of the first-ever U.S. Playbook to Address Social Determinants of Health (SDOH). The Playbook highlights ongoing and new actions that federal agencies, including HHS, Department of Agriculture (USDA), Department of Housing and Urban Development (HUD), the Department of Veterans Affairs (VA), and the Environmental Protection Agency (EPA), are taking to support health by improving the social circumstances of individuals. Additionally, HHS released a Call to Action to Address Health Related Social Needs and a Medicaid and CHIP Health-Related Social Needs Framework to further delineate the agency’s SDOH health goals and activities.
NASTAD Submits Comment in Support of SOGI Data Collection in the American Community Survey
On November 20, NASTAD joined a coalition of over 185 organizations and signed onto comments supporting the U.S. Census Bureau’s proposal to conduct a test of sexual orientation and gender identity (SOGI) measures on the American Community Survey (ACS). The ACS is a yearly survey that collects population level data to help inform policymaking and federal spending. The coalition applauded the US Census Bureau for taking steps to ensure that federal data collection efforts consistently include measures that can identify the unique needs and experiences of LGBTQI+ people. The inclusion of SOGI data collection in the ACS will support federal efforts to advance equitable policies for LGBTQI+ people and enforce civil rights laws.
NASTAD Submits Comments Opposing FDA’s Proposal to Phase Out General Enforcement Discretion for Laboratory Developed Tests
On November 17, NASTAD submitted comments raising concerns regarding the US Food and Drug Administration’s (FDA) proposal to phase out general enforcement discretion for laboratory developed tests (LDT), which would increase the administrative burden required to collect in-vitro diagnostics (IVD) manufactured by a laboratory, such as HIV and hepatitis diagnostics. In particular, phasing out general enforcement discretion for LDTs would make it substantially more difficult to use alternative or additional sample types, or modify existing tests to meet urgent and emerging public health needs, such as dried blood spot testing and some self-testing methods for HIV. Although the proposal would not impact IVD testing conducted through public health surveillance, the changes would prove to be an administrative and financial burden to many community-based organizations. As such, NASTAD strongly recommends that FDA continue enforcement discretion for HIV, viral hepatitis, STI, and related IVDs offered as LDTs when conducted in conjunction with public health prevention and control programs.
USPSTF Posts Draft Research Plan on Screening for HIV
On November 30, the US Preventive Services Task Force (USPSTF) posted a draft research plan for HIV screening and opened public comment through January 3, 2024. The research plan will probe the benefits, potential harms, and yield of new diagnoses that would result from updated screening recommendations for asymptomatic, nonpregnant adolescents and adults and pregnant persons for HIV. Additionally, USPSTF is proposing to collect data on the benefits and harms associated with current antiretroviral therapy recommendations for PLWH.
Biden Administration Determines it has the Authority to Leverage March-In Rights to Lower Drug Costs
On December 6, the Biden Administration announced that it would issue guidance to federal agencies on implementation of the Bayh-Dole Act (H.R.6933) march-in provision, which empowers the federal government to retain the rights to inventions developed using federal funds, such as drug patents, to lower the price of costly pharmaceutical drugs. An interagency work group led a nine-month review of federal rules and regulations and developed a proposed framework for agencies on the exercise of march-in rights on taxpayer-funded drugs and other inventions. The Department of Commerce National Institute of Standards and Technology (NIST) published the proposed framework on December 8, and will accept public comment through February 6, 2024.
NASTAD/NVHR: Unlocking HCV Care in Key Settings (Summary Report)
The National Viral Hepatitis Roundtable (NVHR) and NASTAD hosted a free two-day virtual convening on September 12th and 13th, 2023. The convening included moderated sessions with presentations and discussions showcasing promising models and best practices for integrating Hepatitis C testing and treatment into four key settings: programs providing medications for opioid use disorder (MOUD), state correctional facilities, federally qualified health centers (FQHCs), and syringe services programs (SSPs).
“In 2021: 72,391 enrollees (27 percent) may not have received one of three services critical for achieving viral suppression—a medical visit, viral load test, or antiretroviral therapy (ART) prescription. 11,316 enrollees (4 percent) may not have received any of the three services. This is particularly concerning because missing these services may mean that these enrollees were at greater risk of negative impacts on their overall health and greater risk of transmitting HIV.”
The report shows a continued decline in new HIV infections and increased uptake of PREP among priority populations, despite persisting racial, ethnic, and gender disparities in access to HIV prevention and treatment services and health outcomes.
Duke Margolis Center for Health Policy: Advancing Hepatitis C Elimination: Implementation Strategy for the Proposed National Program
“In collaboration with stakeholders and experts, the Duke-Margolis Center developed a strategic framework for a national hepatitis C elimination program with the goal of informing an implementation pathway for the Administration’s proposal. The framework reflected learnings from a broad range of successful local and regional programs as described above, including “test to treat” initiatives embedded in community based primary care models; effective management of COVID-19 and other respiratory pathogens resulting from improved diagnostic technologies and public health analytics; and provider payment reforms with greater accountability for important population health outcomes.”
“In short, it is not the USPSTF’s job to set payer policy. To do this, the USPSTF’s charge and expertise would necessarily need to include economic analysis as well as valuation methodology. If the author wants to advocate adding these factors to USPSTF review, we would stand behind him to support it.”
GU O’Neill Institute: Seizing the Moment: Elevating Black Women in the HIV Response
“In recent years, significant progress has been made in lowering rates of HIV transmission among U.S. women, including U.S. Black women. This progress is now at risk. It is crucial to take more focused and strategic actions to protect and enhance this progress by recognizing and empowering Black women as visible and valuable partners in the fight to end the HIV epidemic.”
Colorado Division of Insurance: 2024 Colorado Division of Insurance HIV Prevention and Treatment Coverage Guide
“The Colorado Division of Insurance (DOI), part of the Department of Regulatory Agencies (DORA), has created a guide on insurance coverage of prescription medications to prevent and treat HIV, a virus that attacks the body's immune system that can lead to AIDS if left untreated. The tables in the guide summarize medication coverage for each health insurance company offering individual plans (meaning coverage not through an employer) and small group plans (for small employers with less than 100 employees) for 2024. It can be used to review the coverage and drug lists of HIV prevention and treatment medications by each insurance company. These tables do not review each plan from the insurance companies, nor all formularies offered by each company, so it is important for consumers to review plans to confirm coverage. The guide lists medications individually by treatment category, as well as by the most commonly prescribed medications by providers for consumers, as specified by the Food and Drug Administration (FDA).”
“To better understand barriers and associated challenges with access to buprenorphine, the Office of the Chief Medical Officer at the Substance Abuse and Mental Health Services Administration and the Office of the Assistant Secretary of Health, on behalf of HHS, convened a Policy Priority Roundtable on Buprenorphine Access and Availability in Pharmacy Settings. This report is based on stakeholder input from the August 11–12, 2022 roundtable.”
“During the pandemic, reported congenital syphilis cases in Chicago increased an average of 74% per year, more than 3 times the increase in reported cases of syphilis in women of reproductive age (22% per year).”
“In this cross-sectional study including 17,458 decedents, from 2018 to 2021, drug overdose mortality ratios rose (more than 3-fold in pregnant and postpartum individuals aged 35 to 44 years) across the pregnancy-postpartum continuum (the highest during late postpartum period since July 2020). Overdose decedents differed from obstetric decedents in sociodemographic characteristics (younger, less education, unmarried), place of death (outside health care settings), and available health care resources.”
Director, Infectious Disease Program – Atlanta, GA
This role serves as the infectious disease director overseeing the HIV, sexually transmitted diseases (STD), and tuberculosis (TB) programs within the Division of Medical and Clinical Services. Develops and oversees the implementation of programs' goals, objectives, policies, and procedures to accomplish the mission of the Agency. Provides leadership and directs subordinate managers and staff. Maintains fiscal and administrative oversight of program activities. Apply by December 13.
Viral Hepatitis Prevention Coordinator – Austin, TX
Under direction of the Prevention Unit, provides highly advanced, senior-level consultative services and technical assistance as the DSHS viral hepatitis prevention coordinator. Oversees implementation and maintenance of viral hepatitis prevention efforts by identifying ways to integrate viral hepatitis prevention, vaccination, testing, and linkage to care into existing public health, clinical care, and community settings. Responsible for developing a DSHS viral hepatitis prevention plan as well as legislatively-mandated plans, including working with branch staff to solicit input from the public, including experts on Hepatitis, on the tenets of the plan.
Program Content and Training Specialist, Supporting Harm Reduction Programs (SHaRP) – University of Washington
This position is part of a cooperative agreement award from the Centers for Disease Control and Prevention to provide technical assistance about monitoring and evaluation to syringe services programs (SSPs) as part of the National Harm Reduction Technical Assistance Center. One of the primary projects of this award is to provide technical assistance (TA) to SSPs for monitoring and evaluation activities. The University of Washington is working in collaboration with the CDC, SAMHSA, NASTAD, the National Harm Reduction Coalition, and other TA partners to provide a suite of technical assistance support to individual programs.
Communicable Disease Epidemiologist – Cheyenne, Wyoming
This position will serve as the Communicable Disease AIDS Drug Assistance Program (ADAP) Coordinator, Wyoming TB Controller, and Disease Intervention Specialist (DIS) for the Communicable Disease (CD) Treatment Program. Assist in outbreak response to ensure the safety of Wyoming residents; by interviewing cases for exposure information, updating news outlets on the progress of outbreak control, and analyzing exposure data utilizing epidemiological and statistical methods.
Open Positions – New York State
The New York State Department of Health, in partnership with Health Research, Inc, has various job openings, including some within the AIDS Institute. Please visit this link to learn about their current opportunities.
“But nearly a decade later, at least 2.4 million Americans remain infected with hepatitis C. About two in five people with hepatitis C don’t even know that they have the virus. Of those who do, many do not have access to the cure. Congress has an opportunity to turn this ongoing human tragedy into a public health advancement, by providing support for a five-year project to eliminate hepatitis C in the United States. But the time available for approval is growing short… Put simply, we are squandering one of the most important medical advances of the 21st century. It’s time to eliminate this threat to the health of Americans.”
“President Joe Biden has proposed to do something about that. His 2024 budget calls for a campaign to “eliminate” hepatitis C by making sure at-risk people are aware of the disease and its cure, giving providers the training and tools to identify cases early, and getting the medication to everyone who needs it. Although nobody believes the campaign would actually wipe out the disease, at least in the near term, experts think it could dramatically reduce its incidence ― and the death toll too.”
“Thousands of Black men could benefit from the medication, but relatively few are taking it. About 1.2 million people in the US were living with HIV in 2021, the most recent year for which data is available, according to the CDC. More than 52% of new HIV infections that year were among people who lived in the South.”
“Donald Trump couldn’t repeal Obamacare in 2017, largely because it had become too popular. It’s even more popular now….When Trump said last week he’d try again to repeal the law if he wins next year’s presidential election, he did more than pick at an electoral scab that party strategists hoped had healed by now. He threatened to bring back to life a potent electoral issue that contributed significantly to the GOP’s wipeout in the 2018 midterms and on which public opinion has only moved away from Republicans since.”
“The DEA wants to cut production quotas for oxycodone, hydrocodone, and other opioids for the 8th straight year, and invited people to comment on its plan in the Federal Register. Over 3,400 have so far, most of them patients who already have problems getting prescription opioids due to shortages. ‘This will do nothing but harm the chronic pain community,’ one poster wrote. ‘The reduction of opioid production will only cause more overdoses, because when people can’t find medication and are suffering, often their only option is to turn to drug dealers.’”
“Many Democrats and Republicans want tougher laws and longer prison sentences to combat fentanyl. But Vincent has emerged as one of the leading voices in the U.S. pushing to humanize and rally help for drug users, like herself, even when they're not yet willing or able to live sober. ‘We have made it OK to abandon people who use drugs. We tell an entire group of people it's OK if they die,’ she said. With total drug deaths in the U.S. now topping 112,000 fatalities a year, she argues the U.S. focus on law enforcement and drug abstinence hasn't worked and it's time to try something new.”