Rural Health Information Hub Latest News

FDA Announces an Emergency Use Authorization for Moderna Vaccine Candidate

The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 18 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

A link to the full FDA press release is here. The press release also provides information and discussion on available safety and effectiveness data.

You can review the full Moderna COVID-19 Vaccine EUA Letter of Authorization here.

In addition to the EUA letter, below are links to fact sheets from the FDA:

Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers)

Fact Sheet for Recipients and Caregivers

Operation Warp Speed and private sector partners now begin distributing the first allocation of doses to sites designated by the public health jurisdictions and five federal agencies with which OWS and CDC have been working to plan distribution. HHS Secretary Alex M Azar II and Acting Secretary of Defense Christopher C. Miller have issued statements on this next step, and they can be viewed here.

For more information on COVID-19 vaccines, the EUA process, and guidance to industry for developing a COVID-19 vaccine please visit:

COVID-19 Vaccines

Emergency Use Authorization for Vaccines Explained

Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry

Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry

A Crisis of Connectivity: Internet Access in Rural Pennsylvania

By Jordan Wolman / Editor-in-Chief of The Brown and White, Lehigh University.  This story was produced in partnership with the Pulitzer Center on Crisis Reporting.

Tim Westgate walks down from his house, cell phone in hand, to his dock on Lake Underwood.

 

He then gets into his pontoon boat. It’s quiet on the water. It’s quiet almost everywhere in this corner of rural Pennsylvania’s Wayne County.

If he holds his phone up while he’s out on the water where there’s a clearing, Westgate says, he might get two or three bars of signal. It’s the closest place he can go to connect to the outside world.

Westgate has no internet at home. Instead, he regularly makes the 1.5-mile drive to the nearest library, where he can sit in the parking lot and access free Wi-Fi.

But when COVID-19 hit, those challenges only grew.

Tim Westgate. Photo | Jordan Wolman

Westgate said his son moved up to Wayne County with him this past May after graduating from a technical school in Delaware for physical therapy. But once he arrived, applying for a license to practice physical therapy in Pennsylvania became a chore because of their lack of internet and the closure of state offices due to the pandemic.

Westgate said his son would join him at Sunday church extra early to access the building’s Wi-Fi to work on his cover letters and job applications.

As for Westgate himself, a retired optometrist, his weekly Bible study classes have been moved to Zoom since the pandemic began. In order for Westgate to tune in on Tuesday nights at 7:30 p.m., he not only needs to drive to the library, he needs to find a street light to park under — so people on the call are able to see him.

Westgate then climbs in the backseat, resting his device on the truck’s center console.

“There’s no access here,” he said of the area.

Westgate isn’t the only one with no internet.

Honesdale is Wayne County’s most populous municipality and home to 5,000 people. It’s known for its homey Main Street, where residents come in to eat at one of the town’s classic diners and greet the wait staff by name.

The pace is slow but comfortable. On one end of Main Street, there’s a picturesque bridge crossing over a river with mountains rising gently behind it. The fall colors are radiant in this part of the state.

But walk five minutes, and Bruce Johnson doesn’t have the internet connection he needs to work from home.

Read the full article.

CDC Launches Vaccine Inquiry Center for Health Care Providers

The CDC’s Vaccine Inquiry Center for all health care providers is now available to answer vaccine questions. You may send all inquiries to: eocevent168@cdc.gov

The CDC is also pointing people to this HRSA resource: COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured | Official web site of the U.S. Health Resources & Services Administration (hrsa.gov)

Pennsylvanians Working with Children: Deadline is December 31 to Renew FBI Background Checks for those Extended Under Act 18 2020

The deadline for Pennsylvanians needing Federal Bureau of Investigation (FBI) criminal history background checks as a condition of employment is December 31, 2020. Earlier this year, Pennsylvania Governor Wolf signed Act 18 of 2020, which extended the time period for certain professions required by the Child Protective Services Law (CPSL) to obtain an FBI background check upon hiring.

In order to receive an FBI background check:

  • Fingerprints must be submitted as part of the criminal history check.
  • Fingerprint scans can be taken at any IdentoGO location in the commonwealth.

Under Act 18 of 2020, some individuals who are required to obtain an FBI background check were given additional time to meet this requirement because of closures caused by the COVID-19 pandemic. New hires and individuals seeking a renewal of the FBI Criminal History Background Check have until December 31, 2020, to obtain the check. All individuals required to obtain additional clearances, including the Pennsylvania State Police Criminal Record Check and the Pennsylvania Child Abuse History Clearance, must still obtain these clearances prior to employment. Both of these clearances can be obtained online.

As of January 1, 2021, failure to obtain the FBI background check prior to employment and every 60 months thereafter will result in noncompliance with the CPSL and will prohibit individuals from working with children.

IdentoGo Locations

  • A map of all open IdentoGO locations is available here.
    Many IdentoGO locations were temporarily closed in the spring, and this map is updated as offices reopen or new offices open. Anyone seeking fingerprinting services should call IDEMIA’s customer service at 844-321-2101, to ensure the location is still operating, schedule an appointment, and discuss necessary COVID-19 safety precautions.

For Employers

If employers have a large number of employees needing new or renewed clearances, arrangements can be made to have fingerprinting occur at the workplace. Mobile fingerprinting services are available for an additional fee through IDEMIA for groups of 20 or more needing clearances. Agencies with this need should contact IDEMIA to schedule.

COVID-19: Add-on Payment for New Treatments

CMS issued an Interim Final Rule with Comment Period, which established the New COVID-19 Treatments Add-on Payment (NCTAP) under the Medicare Inpatient Prospective Payment System (IPPS), effective from November 2, 2020, until the end of the Public Health Emergency (PHE) for COVID-19. To mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments during the COVID-19 PHE, the Medicare program will provide an enhanced payment for eligible inpatient cases that involve use of certain new products with current Food and Drug Administration approval or emergency use authorization to treat COVID-19. Visit the NCTAP webpage for more information.

CMS: Monitoring for Hospital Price Transparency

Hospital Price Transparency requirements go into effect January 1, 2021.  CMS plans to audit a sample of hospitals for compliance starting in January, in addition to investigating complaints that are submitted to CMS and reviewing analyses of non-compliance, and hospitals may face civil monetary penalties for noncompliance.

Is your institution prepared to comply with the requirements of the Hospital Price Transparency Final Rule? Effective January 1, 2021, each hospital operating in the United States is required to provide publicly accessible standard charge information online about the items and services they provide in 2 ways:

  • Comprehensive machine-readable file with all items and services
  • Display of 300 shoppable services in a consumer-friendly format

In the final rule, CMS outlined a monitoring and enforcement plan to ensure compliance with the requirements.  We finalized a policy that CMS monitoring activities may include, but would not be limited to, the following, as appropriate:

  • Evaluation of complaints made by individuals or entities to CMS
  • Review of individuals’ or entities’ analysis of noncompliance
  • Audit of hospital websites

If we conclude a hospital is noncompliant with one or more of the requirements to make public standard charges, we may take any of the following actions, which generally, but not necessarily, will occur in the following order:

  • Provide a written warning notice to the hospital of the specific violation(s)
  • Request a Corrective Action Plan (CAP) if noncompliance constitutes a material violation of one or more requirements
  • Impose a civil monetary penalty not in excess of $300 per day and publicize the penalty on a CMS website if the hospital fails to respond to our request to submit a CAP or comply with the requirements of a CAP

See 45 CFR part 180 Subpart C- Monitoring and Penalties for Noncompliance.

Visit the Hospital Price Transparency website for additional information and resources to help hospitals prepare for compliance, including:

COVID Impacts on Rural Dental Care System

Access to oral health care has become a growing concern over the past decade, and the COVID-19 pandemic has had a profound impact on all aspects of the oral health care system. Patients, dental providers, educators, and regulators are being asked to rapidly adjust to the COVID-19 crisis with almost no roadmap. To provide some guidance, the Oral Health Workforce Research Center has developed a new section of their website dedicated to sharing information on immediate impacts to the dental care system as a result of COVID-19, including care delivery, financing, regulation, and education.

New Report from Rural Health Value: How to Design Value‐Based Care Models for Rural Participant Success

The Rural Health Value team recently released a Summit Findings report focused on design of value-based care models to support rural health organization participation and success.

How to Design Value‐Based Care Models for Rural Participant Success: A Summit Findings Report

Based on the input from a two-day virtual summit of rural participants in value-based care models and programs, this report summarizes themes and actionable recommendations that can be used by those designing and supporting value-based care models to improve the viability, relevance, and likelihood of rural health care organization participation and success.

Direct Link:  https://ruralhealthvalue.public-health.uiowa.edu/files/Rural%20VBC%20Summit%20Report.pdf

Top resources on the Rural Health Value website:

Contact information:

Keith J. Mueller, Ph.D., Co-Principal Investigator, keith-mueller@uiowa.edu

NRHA Partnership Offers Access to PPE

The National Rural Health Association (NRHA) is working to support their members with the ongoing PPE shortage by partnering with Project N95 to offer PPE.  This is the same program that is being used by other associations, such as American Medical Association. Practice Project N95 is a nonprofit 501(c)(3) organization working to get critical equipment to frontline workers. Through this collaboration, NRHA members have a special opportunity to purchase the following PPE at bulk pricing and in small quantities:

  • N95 respirators (certified by FDA and NIOSH)
  • 3 and 4 ml Blue Nitrile Powder Free Patient examination gloves
  • ASTM Level 1 and Level 3 surgical masks
  • Level 1 and Level 2 AAMI isolation gowns
  • Hard surface disinfectant
  • Disposable face shields

The equipment is being sourced through a limited-time campaign; therefore, you must order by 3PM EST on December 29, 2020 for this limited-time offer.

Tax exempt providers can submit the necessary documentation during registration.  Before you can access the store where the product detail and pricing information is available, you must register by clicking the link below to learn more about the products and how to purchase them:  shop.projectn95.org/registration

Additional Product Detail:

Item Price Per Box Units Per Box Estimated Ship Date
N95 Respirators – Makrite N95-9500 (Size M/L) $84.80 20 1/22
N95 Respirators – Makrite N95-9500S (Size S) $94.60 20 1/22
N95 Respirators – Protective Health Gear 5160-N95 $175.00 50 1/14
Nitrile Powder Free Patient Examination Gloves – 3 mil thick, 9″ length, sizes S/M/L/XL $17.00 100 2/15
Nitrile Powder Free Patient Examination Gloves – 4 mil thick, 9″ length, sizes S/M/L/XL $19.00 100 2/15
ASTM Level 1 Masks – Metiko $8.50 50 1/16
ASTM Level 3 Masks – BYD FE2311X $17.50 50 1/16
Hard Surface Disinfectant Spray – Envirocleanse, 32 Oz Bottles $57.48 12 1/14