COVID-19

Concerns regarding potential disruptions to medical and pharmaceutical product supply chains due to COVID-19 cannot be discounted. NASTAD remains in close contact with the major manufacturers of brand-name ARVs and hepatitis C DAAs, none of which are currently reporting manufacturing concerns or supply shortages.

Many commercial and public payers, including ADAPs, have relaxed early fill or quantity limit policies to help people living with HIV and other chronic diseases maintain adequate supplies of prescription medication while practicing physical distancing. However, some issuers are requiring beneficiaries to switch to their PBM’s mail-order pharmacy service for 60- or 90-day supplies of medications typically dispensed every 30 days by a community pharmacy. This generally requires new prescriptions to be submitted by the beneficiary’s provider.

Additionally, many wholesalers have implemented “fair share” allocation processes to manage prescription drug inventories in response to COVID-19-related spikes in demand by pharmacies. To ensure that all pharmacies and direct purchasers, including ADAPs, receive their usual allocations to meet their average monthly dispenses, wholesalers may limit fulfillment of additional orders until all customers have received their usual monthly allocations. In turn, pharmacies may experience challenges meeting early refill and 60- or 90-day fill demands.

Many pharmacies have implemented their own protocols for ensuring access to essential prescription drugs while maximizing physical distancing. These include mail order delivery, courier delivery, curbside pickup, and designated pharmacy hours for highly vulnerable individuals.

NASTAD will continue to track pharmaceutical supply chain disruptions of significance to HIV and viral hepatitis programs. NASTAD members are strongly encouraged to contact Tim Horn regarding any supply chain disruptions or shortages.

There are no Food and Drug Administration (FDA)-approved treatments for COVID-19 or other coronaviruses. The FDA has issued two Emergency Use Authorizations (EUAs) for drugs that may be provided to hospitalized patients with severe disease. A number of agents are being evaluated, including some antiretroviral drug products typically used in the treatment and prevention of HIV, notably Kaletra (lopinavir/ritonavir), Prezcobix (darunavir/cobicistat), and tenofovir.

As per Interim Guidance for COVID-19 and Persons with HIV developed by the Department of Health and Human Services’ Antiretroviral and Opportunistic Infections Guidelines Panels, people living with HIV should not make changes to their antiretroviral therapy regimens for the purpose of preventing or treating COVID-19, except in the context of a clinical trial and in consultation with an HIV specialist. This guidance important, in part, to safeguard against supply chain disruptions for adults and children currently using these regimens for the management of their HIV.

The National Institutes of Health has released its COVID-19 Treatment Guidelines, to be updated frequently as published data and other authoritative information becomes available. The Infectious Disease Society of America has also launched Guidelines on the Treatment and Management of Patients with COVID-19, to be updated continuously.

As testing capacity for COVID-19 ramps up in both the public and private sectors, there may be particular considerations for individuals living with HIV and other chronic conditions. The Infectious Disease Society of America has released guidance for COVID-19 testing, including prioritization of testing for people living with HIV showing symptoms. Because availability of testing and access to testing sites varies by jurisdiction, clients should call their provider to advise on if a test is warranted and how to access one (see CDC guidance on COVID-19 testing). Drive-through testing sites are increasingly being used as a safe way to access testing while adhering to social distancing requirements.

Additional COVID-19 testing resources include:

• Centers for Disease Control and Prevention: U.S. Viral Testing Data
• U.S. Food and Drug Administration: FAQs on Diagnostic Testing for SARS-CoV-2
• American Medical Association: CPT Reporting for COVID-19 Testing

Fraudulent schemes related to COVID-19 have arrived and are being detected in many forms, including peddling fake cures, phishing e-mails, non-existent charitable organizations, price gouging, and insurance fraud.

• U.S. Department of Justice COVID-19 resource page
• Coalition Against Insurance Fraud COVID-19 insurance fraud response center
• U.S. Food and Drug Administration Fraudulent COVID-19 Products

NASTAD is aware that many HIV and hepatitis health department staff are being detailed to state and local COVID-19 efforts, putting an additional strain on already lean programs. Federal HIV and hepatitis partners – particularly those at CDC – are also being detailed away from their HIV and hepatitis posts. We are aware that a communication went out to CDC health department grantees from the Center for State, Tribal, Local, and Territorial Support (CSTLTS) entitled “Guidance for The Temporary Reassignment of State, Tribal, and Local Personnel During a Declared Federal Public Health Emergency.” The guidance details the process by which public health staff can be reassigned for emergency response and references additional CDC resources (available here). The Office of Management and Budget (OMB) has also released guidance with regard to federal grants and activities impacted by COVID-19 and flexibilities available to grantees as operations are affected. Both HRSA/HAB (available here) and CDC (available here) have released additional guidance on how each agency is implementing the OMB flexibilities for grantees.

As jurisdictions continue to recommend isolation, quarantine, and physical distancing protocols, RWHAP grantees – and ADAPs in particular – have been implementing policies to ensure continued access to medications and health care services for clients. In support of these efforts, HRSA’s HIV/AIDS Bureau (HAB) maintains a Frequently Asked Question (FAQ) webpage on the HAB website. Included on the website is information regarding new funding for RWHAP grantees for COVID-19 activities for people living with HIV. HRSA/HAB released 581 awards funded through the CARES Act that will allow grantees to focus on a number of activities around prevention, preparedness, and response activities.

Many ADAPs already have plans in place to ensure access to medications during times of disrupted access (e.g., a natural disaster). ADAPs should work with their PBMs and pharmacy networks to review and deploy existing policies aimed at easing access barriers. See the following resource for a summary of existing policies and flexibilities: AIDS Drug Assistance Program (ADAP) Emergency Preparedness Resource Guide.

Here are some additional considerations for health departments as they work to ensure the continued health and safety of people living with HIV:

• Early refill and dispensing limit overrides: ADAPs have discretion to allow for early refill overrides as well as extend fills to 60-days. ADAPs should work with their PBMs and/or pharmacy networks to implement these policies.
• Streamlined recertification and annual renewal policies: RWHAP Part B programs and ADAPs have discretion to streamline the recertification process, including utilizing self-attestation that there have

There has been little research on the intersection of COVID-19 and viral hepatitis. Some of the resources below suggest that people with hepatitis B or hepatitis C are at increased risk of illness with COVID-19 if they have extensive liver damage or other underlying conditions, such as kidney injury, cardiovascular disease, and diabetes:

• What to Know About Liver Disease and COVID-19 (CDC, May 5) – The U.S. Centers for Disease Control and Prevention (CDC) developed this FAQ to address concerns related to COVID-19 and viral hepatitis, highlighting what people living with hepatitis B and/or hepatitis C infection can do to protect themselves and maintain their health. It also provides guidance for protecting people at risk for hepatitis A virus infection from the ongoing multi-state hepatitis A outbreaks.
• Information about COVID-19 for people living with chronic HBV and HCV (Hepatitis Australia, updated March 20) - This fact sheet provides practical advice on how to protect yourself against COVID-19 while there is limited information about the effect of the virus on people living with viral hepatitis.
• Clinical Insights for Hepatology and Liver Transplant Providers During the COVID-19 Pandemic (AASLD, March 23) - The American Association for the Study of Liver Diseases (AASLD) created this document to provide data and insights on COVID-19 and how it may affect hepatologists and liver transplant providers and their patients.
• Blog: Can a Transplant and Other Immune Suppressed be Cured of COVID-19 (I Help C, March 20)

NASTAD will update and add resources on COVID’s impact on people living with hepatitis as they become available.

Videos:

• Dr. Saab Coronavirus and the Liver Overview (ALF, YouTube, March 20) - In this video, Dr. Sammy Saab from David Geffen School of Medicine at UCLA gives an overview of COVID-19 (Coronavirus) and answers your questions in the first of the American Liver Foundation Coronavirus series.
• COVID-19: A Message to the Community (NVHR, Vimeo, March 18) - Michael Ninburg, Executive Director, Hepatitis Education Project
• Viral Hepatitis: COVID-19 Considerations (NVHR, Vimeo, March 18) - Robert G. Gish, MD

Partner Resources:

• National Viral Hepatitis Roundtable: COVID-19 Resources
• American Association for the Study of Liver Diseases (AASLD): COVID-19 Resources
• Association of Asian Pacific Community Health Organizations (AAPCHO): COVID-19 Resources
• National Viral Hepatitis Roundtable: COVID-19 Alerts
• World Hepatitis Alliance: Guidance for people living with viral hepatitis or other liver diseases

In response to the global COVID-19 pandemic, health departments and community-based syringe services programs (SSPs) have requested recommendations for supporting syringe access and, in turn, people who use drugs (PWUD).

Several harm reduction and public health partners have developed resources for drug user health response that recognize the additional burdens of housing insecurity, treatment adherence, reduced income (including sex work and other types of labor), chronic and compounding illness, including mental health conditions, and inadequate insurance coverage faced by many SSP participants and other people who use drugs.

NASTAD’s COVID-19: Suggested Health Department Actions to Support Syringe Services Programs (SSPs), released April 8, 2020, consolidates many of these recommendations and includes promising strategies and important considerations for health departments working with SSPs that were raised during a March 2020 NASTAD call with health department and community partners to discuss COVID-19 response.

Additionally, the following resources have been created by federal, state, and local agencies and community-based and non-profit partner groups and might be useful to health departments. Please feel free to send additional resources to NASTAD’s Drug User Health team.

• Vital Strategies – Practicing Harm Reduction in the COVID-19 Outbreak
• SAMHSA’s COVID-19 Guidance for Opioid Treatment Programs 
• Drug Enforcement Administration’s guidelines on Use of Telemedicine While Providing Medication Assisted Treatment (MAT)
• Drug Enforcement Administration’s exception for medication delivery by narcotic treatment programs
• CDC Guidance on COVID and Homeless Service Providers
• United States Interagency Council on Homelessness COVID Resource Page
• American Medical Association: Policy recommendations to help patients with OUD, pain and harm reduction efforts
• American Society of Addiction Medicine COVID-19 – Supporting Access to Buprenorphine
• The Network for Public Health Law: 2019 Novel Coronavirus: Legal Preparedness and Public Health Response Efforts
• Health Department Responses to COVID-19: Supporting SSPs and Harm Reduction Programs Webinar
• The Impact of COVID‑19 on Syringe Services Programs in the United States – Notes from the Field
• The Impact of COVID‑19 on Syringe Services Programs in the United States - Graphic

In the midst of addressing the global COVID-19 pandemic, health departments and community-based organizations are continuing to address HIV prevention strategies and respond to the national HIV epidemic. Several national partners have developed resources on HIV + COVID-19, safer sex strategies during COVID-19, and testing and treatment options.

NASTAD will update and add resources on COVID’s impact on HIV prevention as they become available.

• Centers for Disease Control and Prevention- PrEP During COVID-19
• Centers for Disease Control and Prevention- HIV Self Testing Guidelines

Member Resources

• NYC Department of Health and Mental Hygiene- Sex and COVID-19 Fact Sheet
• Oregon Health Authority
  • Sex in the time of COVID-19 Infographic (English)
  • Sex in the time of COVID-19 Infographic (Spanish)

National Partner Resources

• Greater than AIDS- HIV and COVID-19
• National Coalition of STD Directors- COVID-19 Command Center for STD Programs
• Planned Parenthood- COVID-19 and You Sexual Health

As health department responses to community outbreaks of COVID-19 continue to expand and evolve rapidly, federal and state policies are being updated to maximize the impact of disease containment and mitigation strategies.

Emergency Funding

Congress passed an emergency funding bill that was signed into law on March 6, providing $8.3 billion for COVID-19 response activities, including investments public health response activities, research (including vaccine and treatment development), testing capabilities, and medical supply medication procurement. The $800,000 that had been reprogrammed from NCHHSTP last month was returned in this bill.

The President signed Families First Coronavirus Response Act into law on March 18. The package provides free COVID-19 testing through commercial insurers, Medicare Part B, Medicare Advantage, Medicaid and CHIP, as well as funding for tests for people who are uninsured. The Federal Medical Assistance Percentage for Medicaid was temporarily raised by 6.2 percent. While businesses with over 500 employees are exempt from providing paid leave, it does include provisions for small businesses to provide 12 weeks of paid leave through an expansion of FMLA and 10 paid sick days for full time employees and less for part-time employees. Small businesses will receive tax credits for reimbursement of this expansion. It also includes funding for unemployment assistance and nutrition benefits. On March 27, H.R. 748, the CARES Act, the third piece of major COVID-19 relief legislation, was signed into law. The package, which passed unanimously in the Senate and by voice vote in the House, provides $340 billion dollars in emergency appropriations, including an additional $4.3 billion to the Centers for Disease Control and Prevention (CDC), $65 million for HOPWA, $90 million for the Ryan White HIV/AIDS Program (RWHAP). It also includes direct cash payments to people, an expansion of unemployment insurance, and aid to large and small businesses. The section by section outline of health provisions can be found here and the appropriations provisions can be found here.

• The RWHAP funding (discussed above) will supplement existing grants for Parts A, B, C, and D for the COVID-19 response. The funding will modify existing grants and cooperative agreements and will “be awarded using a data driven methodology determined by the Secretary.” On April 15, HHS awarded the funding to 581 recipients across the Ryan White HIV/AIDS Program.
• The HOPWA funding is for additional housing and may be used for COVID-19 related isolation for family members not living with HIV. At least $50 million of the HOPWA funding will be awarded via formula. More information on the HOPWA CARES funding for grantees can be found here.
• The CDC funding is for public health preparedness and response, which includes funding to state and local public health agencies. In addition, there is funding for surveillance and public health data infrastructure. NASTAD is working with national and federal partners to ensure coordination of broader COVID-19 CDC funding with HIV and hepatitis programs.

On April 24, the House and Senate passed H.R. 266, Paycheck Protection Program and Health Care Enhancement Act. The package provides supplemental funding for the Paycheck Protection Program and new funding for various health programs, including:

• $75 billion for hospitals and health care providers for health care related expenses or lost revenues attributable to COVID-19
• $25 billion for COVID-19 testing:
• $11 billion for states, localities, territories, and tribes
• $1 billion for “Centers for Disease Control and Prevention-Wide Activities and Program Support for surveillance, epidemiology, laboratory capacity expansion, contact tracing, public health data surveillance and analytics infrastructure modernization, disseminating information about testing, and workforce support necessary to expand and improve COVID-19 testing”
• $600 million for Community Health Centers to support COVID-19 testing
• $225 million for Rural Health Clinics to support COVID-19 testing

On May 12, the House of Representatives introduced The HEROES Act, which funds their priorities for the next iteration of supplemental COVID-19 funding. The HEROES Act includes funding for state, local, and tribal governments, as well as an investment in COVID-19 testing and contact tracing. The bill also includes an additional $15 million for the Housing Opportunities for Persons with AIDS (HOPWA) program and $10 million for the Ryan White Program. The House plans to vote on the bill on May 15. It is unclear if and when the Senate will take up the bill.

Federal Public and Private Insurance Coverage Actions

The Families First Coronavirus Response Act (FFCRA) and the CARES act – two majors pieces of federal legislation responding the public health and economic crises wrought by COVID-19 – contain a number of provisions expanding access to services:

• Allows states to receive an increased federal Medicaid match (6.2%) as long as they meet the law’s maintenance of effort requirements, including maintaining eligibility standards and covering COVID-19 related testing, treatment, and vaccines for the duration of the public health emergency.
• Requires Medicaid, Medicare, and private insurance (individual and small group market) to cover COVID-19 related testing free to the consumer.
• Gives states the option to expand Medicaid to cover COVID-19 testing to uninsured individuals for the duration of the public health emergency via a State Plan Amendment.
• Requires Medicare Part D plans to provide 90-day prescriptions for beneficiaries.

Justice in Aging provides a comprehensive summary of healthcare provisions in the CARES act and Kaiser Family Foundation provides a summary of the FFCRA provisions. In addition, CMS has published the following Frequently Asked Questions detailing consumer protections and requirements for enhanced Medicaid matching.

CMS has released a number of fact sheets and guidance to instruct Medicaid, Medicare, and individual and small group coverage with regard to provision of a range of services associated with the COVID-19 outbreak. This includes information to healthcare facilities regarding increased and focused inspections, resources for billing for diagnostic testing (including release of new billing codes), guidance on new telehealth flexibilities, including HIPAA enforcement discretion to facilitate scale up of telehealth capabilities), recommendations for elective surgeries and procedures, and fact sheets and information regarding coverage and cost-sharing requirements for preventive services. Because a national emergency has been declared, CMS is also accepting applications for Medicaid 1135 waivers that allow states greater flexibility with regard to provider requirements, prior authorization requirements, and other eligibility rules. More information on federal actions below:

• NASTAD COVID-19 Medicaid Fact Sheet
• NASTAD COVID-19 Medicare Fact Sheet
• NASTAD COVID-19 Private insurance Fact Sheet

State Insurance Regulatory Actions

Several states departments of insurance have issued regulations and orders to ensure that individuals have access to COVID-19 testing and easy access to necessary medications should there be more aggressive containment measures in jurisdictions that prevent travel to pharmacies. These measures – adopted in California, Washington, and New York, as well as a growing list of additional states – include consumer protections like waiving cost sharing associated with COVID-19 testing; allowing early refills for prescriptions; suspending prior authorization for testing or treatment for COVID-19; providing easier access to telehealth medical advice and treatment; and allowing individuals to seek COVID-19 related services outside of their provider network. Additionally, many major commercial insurance plans have put in place similar policies that apply in states even without regulatory action.

NASTAD recognizes and condemns the recent uptick in xenophobic and racist attacks towards Asian American communities that has arisen as a result of this pandemic. We echo Jeffrey Caballero, the Executive Director of the Association of Asian Pacific Community Health Organizations, in the Joint Statement of Asian American and Pacific Islander Leaders and Over 260 Civil Rights Organizations Call on Congress to Denounce Anti-Asian Racism around COVID-19 in strongly condemning incidents of anti-Asian racism:

This is a global emergency that should be met with both urgency and also cultural awareness that COVID-19 is not isolated to a single ethnic population. Xenophobic attacks and discrimination towards Asian American communities are unacceptable and will not make our families safer or healthier.

NASTAD acknowledges that pandemics further exacerbate social prejudices, such as xenophobia, racism, and stigma, which target historically marginalized groups. This rhetoric further perpetuates the health inequities and disparities faced by people placed at risk, including people living with HIV and/or viral hepatitis, and people who use drugs, therefore NASTAD will continue to disseminate accurate and culturally responsive information.

• World Health Organization: Mental Health and Psychosocial Considerations During COVID-19 Outbreak
• UNICEF: Social Stigma Associated with Coronavirus Disease (COVID-19)
• CDC Reducing Stigma
• CDC Know the facts about coronavirus disease 2019 (COVID-19) and help stop the spread of rumors
• Washington State Department of Health: COVID-19 Stigma Reduction
• Trauma Informed Oregon COVID-19 Considerations for a Trauma Informed Response for Work Settings
• American Psychological Association: Combatting Bias and Stigma Related to COVID-19

Correctional and detention facilities present unique challenges for control of COVID-19 transmission among incarcerated/detained persons, staff, and visitors. Consistent application of specific preparation, prevention, and management measures can help reduce the risk of transmission and severe disease from COVID-19. The following resources are available regarding COVID-19 prevention and control in correctional facilities and prisons:

• CDC Interim Guidance on Management of Coronavirus Disease 2019 (COVID-19) in Correctional and Detention Facilities
• American Jail Association COVID-19 Resources
• New England Journal of Medicine Editorial: Flattening the Curve for Incarcerated Populations — Covid-19 in Jails and Prisons
• Prison Policy Initiative: Responses to the COVID-19 Pandemic

NASTAD encourages health departments and public health systems to ensure nondiscrimination in access to critical medical care, services, and equipment, particularly for people living with HIV, viral hepatitis, and those who use drugs.

In response to concerns that people living with HIV may not receive the same COVID-19 care as those in the general population, notably denial of access to a ventilator if a hospital needs to ration critical care, IDSA and HIVMA have updated their COVID-19: Special Considerations for People Living with HIV resource stressing that people living with HIV have a normal life expectancy and:

• HIV status should not be a factor in medical decision-making regarding lifesaving intervention decisions (for example, ventilation) or enrollment into clinical trials, and
• care and treatment for COVID-19 in people living with HIV should follow the same protocols advised for patients without HIV.

Additionally, the HHS Interim Guidance on COVID-19 and Persons with HIV emphasizes the following in its introduction:

People with HIV who have COVID-19 have an excellent prognosis, and they should be clinically managed the same as persons in the general population with COVID-19, including when making medical care triage determinations.

Many jurisdictions have adopted guidelines on the ethical allocations of health care resources during pandemics. These include the New York State Department of Health Ventilator Allocation Guidelines, which call for the use of a triage officer or triage committee, the application of evidence-based exclusion criteria, and assessments of mortality risk using the Sequential Organ Failure Assessment (SOFA) score, to determine priority for initiating ventilation.