Rural Health Information Hub Latest News

Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation

The provisions of this final rule include a process to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after the manufacturer has conducted an audit of a covered entity as authorized by section 340B(a)(5)(C) of the Public Health Service Act, that a covered entity has violated the prohibition on diversion or duplicate discounts.  HRSA will post the final rule on the 340B Drug Pricing Program website.

CMS:  Rural-Urban Disparities in Health Care in Medicare

The Centers for Medicare & Medicaid Services (CMS) uses two sources of information in this summary of the quality of care received by Medicare beneficiaries.  The first source is the Consumer Assessment of Healthcare Providers and Systems (CAHPS) and its survey on health care experiences (e.g., ease of getting needed care, how well providers communicate, etc.).  The second is the Healthcare Effectiveness Data and Information Set (HEDIS) with information collected from medical records and administrative data on the technical quality of care for a variety of medical issues, including diabetes, cardiovascular disease, and chronic lung disease.

HHS Report: Strengthening the Entry-Level Health Care Workforce

The U.S. Department of Health & Human Services (HHS) commissioned an in-depth look at the challenges and opportunities for this segment of the health care workforce that includes community health workers, behavioral health peer support, and home health aides.  Forecasting a shortage across professions, the report identifies entry-level positions as one option for expanding community-level capacity while also increasing employment opportunities.

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.