Jen Laws, President & CEO Jen Laws, President & CEO

Improvements to Public Health Guidelines, Despite Covid-19

2022 is off to a roaring Covid-19 start with both mainstream news and scientific outlets focusing on variant development, diversifying vaccines, and the impacts of the pandemic on various aspects of our lives. Last year, Community Access National Network opened our blog with discussing Covid-19’s Impact on HIV, HCV, and Substance Use Disorder and the theme crawled through our public policy discussions of the last year. While the topic is likely to set the frame for all variety of public health and policy throughout 2022, there is a necessity to discuss the developments in our space in spite of the distractions COVID has to offer.

Early 2021 found the Biden administration rescinding the “axe” the previous administration gave to the so-called “X” waiver, a requirement for providers to seek specified training in order to administer buprenorphine based medication assisted treatment for patients experiencing opioid use disorder. While providers and advocates hailed eliminating the X-waiver as a move toward advancing care, reports stated administration officials found problems with the rule as written, calling it “premature”. The Department of Health and Human Services (HHS) would later update treatment guidelines by way of formal notice posted to the federal register on April 28th, expanding eligibility of providers to administer the treatment when they “intend” to treat fewer than 30 patients a year. What enforcement looks like around the word “intent will be an area to watch as this area of public policy develops.

Later in the year, the Centers for Disease Control and Prevention (CDC) updated their Sexually Transmitted Infections Treatment Guidelines, the first overhaul since 2015. While the most significant updates to the guidelines are focused on the treatment of gonorrhea, an area of focus given the bacteria’s penchant for developing resistance to treatment, other highlights include aligning the guidelines with the CDCs 2020 recommendation for universal Hepatitis C screenings and adoption of the Advisory Committee on Immunization Practices (ACIP) recommendation for Human Papilloma Virus (HPV) “catch-up” vaccination schedules for people assigned male at birth. These and other additional updates were made, in part, because the CDC’s 2021 annual report found the United States facing the 6th consecutive year of STI increases.

Among ACIP’s many accomplishments in a year that found the panel meeting nearly twice as often as usual, a November meeting overshadowed by the endorsement of recommending Covid-19 vaccines for 5-11 year olds provided also found ACIP recommending universal adult Hepatitis B vaccination.

In a similar vein to the aforementioned updates (and with much rejoicing from advocates), the White House Office of National AIDS Policy “turned the lights back on” with the appointment of Harold Phillips as Director. Mr. Phillips provided an update to the National HIV/AIDS Strategy, announced in December with a focus on acknowledging structural barriers to achieving goals, including racism, stigma, and violence against transgender women. The plan, however, does not specifically outline ways to address these particularly challenging, systemic issues. President Biden also recognized World AIDS Day with a characteristically frank review of the history this country has with HIV and AIDS and the obstacles we still face in working to Ending the HIV Epidemic.

One of the last developments of 2021 included the CDC updating its clinical practice guidelines for pre-exposure prophylaxis for the prevention of HIV (PrEP). The update shifts language in such a way to encourage providers to more openly bring up the issue of PrEP with all patients rather than solely seeking to target “high-risk” populations. This move falls in-line with the efforts to reduce PrEP stigma among the broader public and, specifically, among providers. This was a particularly exciting development in light of the Food and Drug Administration’s (FDA) approval of cabotegravir (branded as Apretude) for PrEP. The long-acting injectable was first approved for the treatment of HIV in early 2021 and poses an extraordinary advancement in the potential for medication delivery mechanisms, improving adherence, and, ultimately, advancing efforts to End the Epidemic. Of note, pharmacy benefit managers, specifically CVS, anticipated this move as much as advocates and patients have. Despite a supposed commitment to investing in health equity with regard to HIV, CVS’ own “payor solutions” site boasts of the methods the entity will use seeking to delay or deny access to this and other innovative care under the need to “balance cost” with effective or curative treatments.

Looking into the new year, HHS’ annual policy report indicates the agency will seek to strengthen protections afforded to LGBTQ patients and more appropriately define discrimination in plan design, affecting patients living with HIV and HCV.

While these changes in direction and advancements in treatment are quite thrilling, advocates should be prepared to compete for space to be heard and anticipate familiar “foes” continuing to refuse to engage or finding ways to blockade access to care. Be they based in political ideal or industry priority or even from providers, patients and advocates would be better served when those who have traditionally disfavored advancing equity and access engaged in discussions on how to find the win-win for all parties. Community Access National Network remains committed to engaging stakeholders across interests in this space and looks forward to the good-faith efforts of those who seek to move these adversarial relationships to partnerships and even friendships.

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Jen Laws, President & CEO Jen Laws, President & CEO

Highlights from the Viral Hepatitis National Strategic Plan

On January 7th, the Department of Health and Human Services announced publication of an updated plan to eliminate viral hepatitis in the United States.  This “roadmap” coincides with HHS’s release of the first Sexual Transmitted Infections (STI) National Strategic Plan on December 18th, 2020, and an update to the HIV National Strategic Plan on January 15th, 2021.

Notably, these documents reference one another and specifically call for integrated efforts to tackle these syndemics across stakeholder groups, specifically including substance use-disorder as part of a “holistic” cohort. Additionally, each contains a near identical vision statement:

- The United States will be a place where new viral hepatitis infections are prevented, every person  knows their status, and every person with viral hepatitis has high-quality health care and treatment and lives free from stigma and discrimination.

- The United States will be a place where new HIV infections are prevented, every person knows their status, and every person with HIV has high-quality care and treatment and lives free from stigma and discrimination.

- The United States will be a place where sexually transmitted infections are prevented and where every person has high-quality STI prevention, care, and treatment while living free from stigma and discrimination.

All three vision statements end with the following: This vision includes all people, regardless of age, sex, gender identity, sexual orientation, race, ethnicity, religion, disability, geographic location, or socioeconomic circumstance.

Each plan addresses a limited but indefinite list of social determinants of health such as socio-economic burdens impeding access to care, including racism, intimate partner violence (IPV), and stigma and acknowledges discrimination against sexual and gender minorities (SGM). COVID-19 is mentioned repeatedly as underscoring and providing a highlight to the United States’ excessive health disparities, giving a nod to the unfortunate…”opportunity” the pandemic has provided health care advocates working with or as a part of these highly affected, highly marginalized communities. “The pandemic has exacerbated existing challenges in the nation’s public health care system, further exposing decades, if not centuries, of health inequities and its impact on social determinants of health.” Plans also acknowledge personnel and resources from programs addressing STIs, viral hepatitis, and HIV have been heavily redirected toward efforts to address COVID-19.

All plans call for better data sharing across providers and reporting agencies and an increase in surveillance activities, with an emphasis on local-level efforts to rely on local data, rather than national-level trends. Each plan also calls for expanded testing, interventions, linkage to care, provider and community education, and access to treatment, including incarcerated populations. The Viral Hepatitis National Strategic Plan (VHNSP) described “poor quality and a paucity of data” as clear impediment to meeting the goals of the plan. Sparring no stakeholder with access, the plan highlights a need for data sharing among correctional programs, health insurers, public and private health systems, mental and behavioral health, public health entities, and more.

The VHNSP also acknowledges opportunities to take lessons from the fight against HIV and the need to integrate “treatment as prevention” as a powerful tool in combating new HBV and HCV infections.

The Viral Hepatitis Strategy National Plans notes the following key indicators:

  • On track for 2020 targets:

    • HBV deaths

    • HCV deaths

    • HCV deaths among Black People

  • Trending in the right direction:

    • HBV vaccine birth dose (87% for people born between 2015-2016 by 13 months, WHO recommends 90% by 13 months)

    • HBV vaccine among health care personnel

    • HBV-related deaths among Black people

    • HBV-related deaths among people over the age of 45

  • Not on track:

    • New HBV infections

    • New HCV infections

    • New HBV infections among people 30-49 years of age

    • HBV-related deaths among Asian Americans and Pacific Islanders

    • New HCV infections among people of 20-39 years of age

    • New HCV infections among American Indians and Alaska Natives

The plan recognizes an 71% increase in HCV infections in reporting years 2014-2018 and points toward a strong data correlation between these new infections and the opioid epidemic, based on local area reporting data. Care related challenges include lack of personal status knowledge, perinatal transmission, and cost of curative treatment.

The plan states ideal engagement in various activities across an astoundingly broad scope of stakeholders including faith-based organizations for outreach and education, stigma and anti-bias training among all client-facing personnel, the opportunity to engage comprehensive syringe services programs as an outlet to provide HCV medication and more traditional services like referral for opioid-use disorder, educating providers and employers about federal protections for people with viral hepatitis, increasing awareness through school education programs – specifically culturally sensitive and age-appropriate sex education programs.

From issues of criminalization laws to lack of cohesive data collection, overall, the plan is very welcomed, comprehensive approach toward addressing viral hepatitis. With the STI and HIV plans mirroring very closely.

While the plans call stakeholders to address economic barriers to care and other social determinants of health, specifics are lacking. Stakeholders may wish to consider some of the priorities in the Biden administration’s public health approach including hiring from affected communities (including reducing or allowing alternative education requirements like live-experience or consideration of on-the-job training opportunities). These lofty goals may also require regulatory changes in order to implement and realize them fully (i.e. mechanisms incentivizing correctional facilities and the Veterans Administration to share data with local or state health departments and establish linkage to care programs). Private funders would be wise to take advantage of this opportunity and fund innovative, comprehensive pilot or demonstration projects. Advocates would be wise to leverage these documents when seeking state-level regulatory changes and advocating for federal funding and program design.

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