Rural Health Information Hub Latest News

NIH Phase 3 Clinical Trial of Investigational Vaccine for COVID-19 Begins

The National Institutes of Health (NIH) is seeking volunteers for a clinical trial to test the effectiveness of a vaccine developed to prevent coronavirus disease 2019 (COVID-19).  The trial, which will be conducted at U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19.  Get more information from a Q&A about the phase 3 trial.  You can also watch a 30-minute interview with a volunteer from the phase 1 clinical trial, who is joined by NIH Director Francis Collins and Dr. Anthony Fauci.  (Note: the video has some tech difficulties in the beginning).

New Reports from Rural Health Advisory Committee

The National Advisory Committee on Rural Health and Human Services convenes twice each year for close examination of issues by a panel of more than 20 experts.  The most recent recommendations to the Secretary of HHS come from its March 2020 meeting in Atlanta.  They are: HIV Prevention and Treatment Challenges in Rural America, and Maternal and Obstetric Care Challenges in Rural America.  Read more about publications here.

The Next COVID-19 Casualty: Housing Security

23 million Americans are at risk of eviction and exposure to the shelter system due to the pandemic, the AP reports, citing the Aspen Institute. The latest Census Bureau Household Pulse Survey found last week that more than 26.5 percent of American adults 18 or older questioned said they were not able to make last month’s rent or mortgage payment and had little or no confidence they could pay next month, the AP notes. While many lower-income Americans initially got by on credit cards and stimulus checks, those options are now gone, leaving many in a huge financial hole. Of note, the Pennsylvania Supreme Court dismissed a lawsuit by landlord advocates that challenged Gov. Tom Wolf’s statewide order against banning evictions during the coronavirus pandemic.

40% of Americans Still Putting Off Care

Roughly 40 percent of Americans have postponed getting medical care due to the coronavirus outbreak. That number has stayed around 40 percent in all 12 weeks of the Census Bureau’s Household Pulse Survey. Hospitals and doctors started rescheduling surgeries and other appointments as early as mid-May, and many patient volumes are mostly back to pre-pandemic numbers, Axios’ Bob Herman writes. But this data suggests there is still a major backlog of Americans who need care – a phenomenon that existed well before the pandemic.

Look-Alike COVID-19 Funding Question and Answer Session

HRSA’s Bureau of Primary Health Care (BPHC) and Office of Federal Assistance Management (OFAM) will host a question and answer session for the recipients of Look-Alikes: Expanding Capacity for Coronavirus Testing (LAL ECT) funding. This session is an opportunity for LALs to receive clarification on key fiscal and grants management requirements and hear strategies to ensure compliance and properly manage the LAL ECT award. Join the webcast the day of the session; Wednesday, Aug. 12 from 2:00-3:00 pm. Call-in: 888-972-9343; Passcode: 2324051. If you have questions to submit ahead of time, send them to OFAMFTA@hrsa.gov. You are also encouraged to watch the BPHC/OFAM Fiscal and Grants Management Orientation webinar held last month.

DOL Issues Return-to-Work Guidance Under FFCRA

On July 20, 2020, the U.S. Department of Labor (DOL) issued guidance on return-to-work issues under the Families First Coronavirus Response Act (FFCRA). Enacted on March 18, 2020, the FFCRA provides emergency paid sick leave, fully paid for by the federal government by way of refundable tax credits and paid family leave under the Family and Medical Leave Act (FMLA) for certain qualifying employees affected by the COVID-19 pandemic. The following three areas were updated in this recently issued additional guidance:

  • Paid Leave Clarifications: DOL clarifies that the period an employee was furloughed cannot count against their FFCRA or FMLA leave entitlement.
  • Return-to-Work Positions: Provides direction to employers who have staff returning to work after caring for a family member exposed to COVID-19.
  • No Retaliation: Makes it clear that employers may not discriminate against an employee for the use of FFCRA or influence any employment decisions based on the possible future use of FFCRA leave when returning staff to the workplace.

The DOL previously issued guidance in late June which clarified worker’s rights to FFCRA leave for school, camp or other child care closures affecting them during the summer months. The FFCRA’s leave provisions are currently scheduled to expire on Dec. 31, 2020.

New 340B Registration and Recertification Requirements

The Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) is introducing new requirements and enhancements to the new covered entity registration and recertification in the 340B Office of Pharmacy Affairs Information System (340B OPAIS). These new requirements and enhancements became effective in the registration component of 340B OPAIS beginning August 1, 2020. Some of the requirements/enhancements only impact certain entity types.

The Medicaid billing question is modified as follows: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” This change was made to clarify that the question is specific to Medicaid fee-for-service to a covered entity site and to clearly delineate each Medicaid state that is billed for 340B drugs, and the billing number(s) listed on the bill to the Medicaid state. For more information, please review the OPA Program Update – July 2020.

Update on 340B Developments

Since July 1 there has been an attack on the 340B program and contract pharmacies. This is a high priority advocacy issue for NACHC and PACHC. NACHC is coordinating strategy to combat these attacks on the 340B program including potential legal actions and an extensive public relations (PR) campaign. To assist with the PR campaign, FQHCs are asked to create a one-pager to highlight the importance of the 340B program, with an emphasis on the services you are able to provide to communities because of the savings from the 340B program. Click here for a copy of the template. NACHC is also working on a 340B response toolkit to be distributed soon. NACHC has put together a summary of what has occurred and guidance. 340B Health, a coalition of 340B providers, put together an analysis of the request from Merck. Stay tuned for updates and additional resources.

Millions Losing Coverage Seek Alternatives

Health Insurance Marketplace enrollment has increased due to millions losing employer sponsored coverage and employment across the nation. This enrollment spike nationwide may draw other insurers to state-based exchanges, reducing the per-person costs for insurers with the addition of healthy people looking for coverage. An increase in Medicaid rolls nationwide is partially due to states pausing eligibility redeterminations during the public health crisis as required under the Families First Coronavirus Response Act. To date, Medicaid enrollment has increased 1.3 percent in Pennsylvania.