Rural Health Information Hub Latest News

FDA Approves First At-Home Coronavirus Tests

The Food and Drug Administration on Tuesday issued an emergency use authorization for the country’s first coronavirus test that can run from start to finish at home without the need for a prescription. People as young as 2 years old are cleared to use the test, which takes just 15 to 20 minutes to deliver a result. Unlike many similar products, which are only supposed to be used by people with symptoms of COVID-19, this test is authorized for people with or without symptoms. Read more. A day after the FDA authorized the nation’s first home COVID-19 test, it on Wednesday cleared a second home test made by Abbott Laboratories. Abbott said the rapid BinaxNow home test will cost $25 and be available through a telehealth provider, eMed, which will determine whether a person is eligible. Only people with COVID-19 symptoms can get the home test.

Pregnant Employees Asked to Consider COVID-19 Vaccination

The COVID-19 vaccine was not tested in pregnancy, but experts say it’s still worth considering if you’re expecting. As healthcare workers prepare to receive Pfizer’s COVID-19 vaccine starting this week, a Centers for Disease Control and Prevention committee has recommended that pregnant workers–a group typically excluded from vaccine trials–still be allowed to decide with their doctors whether to receive the vaccine. Read more.

Phase 3 Provider Relief Funding Distribution Starts

The Health Resources and Services Administration (HRSA) announced that it has completed a review of Phase 3 applications from the Provider Relief Fund (PRF) program and will distribute $24.5 billion to over 70,000 providers. Up from the $20 billion originally planned, the addition of another $4.5 billion in funding is being used to satisfy close to 90 percent of each applicant’s reported lost revenues and net change in expenses caused by the coronavirus pandemic in the first half of 2020. The U.S. Department of Health and Human Services (HHS) recognizes this pandemic has upended the health care system and caused significant financial hardships. These resources, along with previous distributions, have provided much needed relief. Payment distribution started Wednesday and will continue through January 2021. Read more.

DOH Guidance for Healthcare Personnel with Signs and Symptoms Following COVID-19 Vaccination

The Pennsylvania Department of Health has provided guidance for responding to signs and symptoms following COVID-19 vaccination in healthcare personnel (HCP). Strategies are needed for healthcare facilities to appropriately evaluate and manage post-vaccination signs and symptoms among healthcare personnel (HCP) to minimize staffing disruptions and transmission of infectious diseases, including COVID-19. Key points in the advisory include:

  • Signs and symptoms, such as fever, fatigue, headache, chills, myalgia, and arthralgia, can typically occur following COVID-19 vaccination, usually within the first three days of vaccination.
  • Presence of signs and symptoms consistent with SARS-CoV-2 infection that are not typical for post-vaccination signs and symptoms (i.e., cough, shortness of breath, rhinorrhea, sore throat, loss of taste or smell) should not be attributed to the COVID-19 vaccine.
  • Positive viral (nucleic acid or antigen) tests for SARS-CoV-2, if performed, should not be attributed to the COVID-19 vaccine, as vaccination does not influence the results of these tests.

The steps healthcare facilities should take in response to HCP who develop symptoms in the 3 days following vaccination for COVID-19 are outlined. If you have questions about this guidance, please contact DOH at 1-877-PA-HEALTH (1- 877-724-3258) or your local health department. Click here to access all the 2020 DOH Health Alerts, advisories and updates.

HHS Uses Multiple Mechanisms to Ensure 340B Compliance

The Government Accountability Office (GAO) recently published a report examining how the Department of Health and Human Services uses audits and other efforts to assess the compliance of covered entities with the 340B law related to eligibility, among other things. HHS audits have found more than 1,500 instances of noncompliance since FY 2012. Also, HHS officials told GAO that it is hard to correct noncompliance in certain areas, such as patient eligibility, because the law doesn’t address those areas in detail.

340B Dispute Resolution Final Rule Released

The U.S. Health Resources and Services Administration (HRSA) published a final rule that “sets forth the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process” in the Federal Register on Dec. 14. The rule takes effect on Jan. 13, 2021. The purpose of the ADR process is to resolve:

  • Claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers
  • Claims by manufacturers, after a manufacturer has conducted an audit as authorized by the 340B statute, that a covered entity has violated the prohibition on diversion or duplicate discounts.

The final rule incorporates a large majority of the suggestions that NACHC made in response to the original proposed rule.

Attorneys General Join Forces to Save 340B Pricing at Health Centers

A bipartisan coalition of 29 attorneys general in a letter to the U.S. Department of Health and Human Services (HHS) urges HHS to hold accountable drug manufacturers that are unlawfully imperiling access to affordable prescriptions for low-income patients. Pennsylvania’s Attorney General Josh Shapiro signed on to the letter as did Xavier Becerra, President-Elect Biden’s pick for HHS Secretary.

All Pennsylvania Counties Received Rapid Antigen Test Cards

Pennsylvania Governor Wolf’s Administration began distribution of the 10th allotment of COVID-19 antigen test kits provided by the federal government to Clinical Laboratory Improvement Amendments (CLIA)-certified institutions in the remaining 20 counties that have not yet received a shipment. All 67 counties have now received shipment of antigen tests. The test detects an antigen on the surface of the SARS-CoV-2 virus while the Polymerase chain reaction (PCR) test detects viral RNA. Both PCR and antigen tests can detect active infection and are considered diagnostic tests. Antigen tests can be considered for symptomatic individuals (within the first five to seven days of symptom onset) and in asymptomatic individuals in settings where there is a high probability that the individual to be tested is positive, such as when they are a close contact of a case. On Oct. 15, the Secretary of Health issued an Order to health care providers and facilities reinforcing that all antigen test results, both positive and negative, are required to be reported to the Department of Health. If you have questions about tests, please contact Eric Kiehl, PACHC Director of Public Policy and Partnerships.