This flowchart from the Centers for Medicare & Medicaid Services (CMS) guides providers on how to bill Medicare for COVID-19 testing for beneficiaries in skilled nursing facilities/nursing facilities.  It also includes resources and explanations on how to receive reimbursements for testing if residents have Medicaid, private health insurance, or no health insurance.  Find more information here.

A firm that was among nine companies to receive a reward from the National Institutes of Health is developing a molecular test for COVID that it anticipates will be affordable for rural hospitals and has the potential to broaden testing in an underserved population.

MatMaCorp received part of a $129.3 million NIH award to expand COVID testing and manufacturing capacity.

The Lincoln, Nebraska-based firm did not disclose the amount of the award, it said the money supports a testing platform for agricultural diagnostic applications, such as the detection of congestive heart failure in cattle.

MatMaCorp, founded in 2014, said its platform expedites testing and addresses a shortage of extraction kit reagents.

Though the firm’s testing platform is portable enough for point-of-care use, the company initially is not planning to place the test near patients in clinics and other CLIA-waived settings for which it would need to obtain a specific regulatory approval. Its highest priority is targeting instruments and test placements in CLIA-certified laboratories attached to critical-care hospitals located in rural communities that are a few hours driving distance from a reference laboratory, MatMaCorp CEO Phil Kozera said in an interview.

“Prior to the pandemic, our focus was solely on animal health and veterinary diagnostics,” he said, “but because of the number of calls we received from colleagues in the rural community, we decided to develop a test for COVID-19. Our colleagues were either unable to get testing done because of the lack of availability or they had to wait too long ─ anywhere from seven to ten days ─ to get results.”

The NIH Rapid Acceleration of Diagnostics initiative was established to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. As part of the program, the NIH is working to expand testing development and distribution across the country in partnership with other government organizations such as the Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, Defense Advanced Research Projects Agency, and Food and Drug Administration.

The NIH noted in a statement that the pandemic has created a need “for accurate, reliable, and readily accessible testing on a massive scale, and returning safely to normal life depends on the ability to streamline and speed up the testing process,” including in underserved and vulnerable populations in rural areas.

If MatMaCorp obtains emergency use authorization, it plans to manufacture instruments and test kits internally. Leveraging an internal sales team, it will aim to target placements of its molecular test at $9,500 per instrument that runs assays at about $30 per test, Kozera noted.

The firm’s instrument can test six samples per run, a level of throughput far lower than many current RT-PCR machines used in hospitals, which can process thousands of samples per day. But the instrument is still suitable for rural community hospitals that must provide testing but have comparatively lower test volumes, Kozera said. The instrument uses lyophilized reagents that operate at ambient temperatures and don’t require refrigeration, an important consideration for rural point of care use, he noted.

Despite being “pivotal to opening up communities,” most rural hospitals have tighter budgets that preclude them from purchasing more expensive platforms that are on the market, and many are finding it challenging to gain access to the level of testing that meets demand, Kozera noted.

Kearney Regional Medical Center, an acute-care 94-bed hospital in Kearney, Nebraska, is beta testing MatMaCorp’s molecular test system and encountering such challenges.

Use of MatMaCorp’s molecular platform can help the hospital provide better service to its patients “with accurate, timely testing” and the assurance that it is not going to be placed on allocation, Tori Seberger, a medical laboratory technician at the hospital, said.

Kearney Regional is limited in the amount of testing it can do by its reference laboratory, she said.

Its allocation of about 50 tests per week limits the hospital to testing specimens collected from patients being admitted to the hospital to determine whether they need to be isolated. With its weekly allocation, the hospital also needs to test its essential workers to keep staffing levels at appropriate levels for patient care, Seberger added.

The hospital receives most results in between 48 hours and 72 hours from the time the lab receives the specimen. That’s an “unacceptable timeframe for many of those being tested,” Seberger noted.

Kearney Regional can better reduce the rate of infection by rapidly isolating people who have SARS-CoV-2 and “allowing healthy people to return to work and stay productive,” she said.

By Tim Murphy and Tim Marema
Nearly half of all rural counties have new-infection rates that the White House task force defines as out of control.
Read more

On September 19, 2020, HHS posted the long-awaited reporting guidance for Provider Relief Funds.  The file is available on the link below.  These requirements are not applicable to the Nursing Home Infection Control or Rural Health Clinic Testing distributions or the HRSA Uninsured Program.

www.hhs.gov/coronavirus/cares-act-provider-relief-fund/…

Note to Readers: Sarah Jane Tribble spent more than a year and half reporting on a small town in Kansas that lost its only hospital. This month, KHN and St. Louis Public Radio will launch “Where It Hurts,” a podcast exploring the often painful cracks growing in America’s health system that leave people vulnerable — and without the care they need. Season One is “No Mercy,” focusing on the hospital closure in Fort Scott, Kansas — and what happens to the people left behind, surviving the best way they know how. You can listen to Episode One on Tuesday, Sept. 29.

David Usher is sitting on $1.7 million he’s scared to spend.

The money lent from the federal government is meant to help hospitals and other health care providers weather the COVID-19 pandemic. Yet some hospital administrators have called it a payday loan program that is now, brutally, due for repayment at a time when they still need help.

Coronavirus cases have “picked up recently and it’s quite worrying,” said Usher, chief financial officer at the 12-bed Edwards County Medical Center in rural western Kansas. Usher said he would like to use the money to build a negative-pressure room, a common strategy to keep contagious patients apart from those in the rest of the hospital.

But he’s not sure it’s safe to spend that cash. Officially, the total repayment of the loan is due this month. Otherwise, according to the loan’s terms, federal regulators will stop reimbursing the hospitals for Medicare patients’ treatments until the loan is repaid in full.

The federal Centers for Medicare & Medicaid Services has not yet begun trying to recoup its money, with the coronavirus still affecting communities nationwide, but hospital leaders fear it may come calling for repayment any day now.

Hospital leaders across the country said there has been no communication from CMS on whether or when they will adjust the repayment deadline. A CMS spokesperson had not responded to questions by press time.

“It’s great having the money,” Usher said. “But if I don’t know how much I get to keep, I don’t get to spend the money wisely and effectively on the facility.”

Usher took out the loan from Medicare’s Accelerated and Advance Payments program. The program, which existed long before the pandemic, was generally used sparingly by hospitals faced with emergencies such as hurricanes or tornadoes. It was expanded for use during the coronavirus pandemic — part of billions approved in federal relief funds for health care providers this spring.

A full repayment of a hospital’s loan is technically due 120 days after it was received. If it is not paid, Medicare will stop reimbursing claims until it recoups the money it is owed — a point spelled out in the program’s rules. Medicare reimburses nearly $60 billion in payments to health care providers nationwide under Medicare’s Part A program, which makes payments to hospitals.

More than 65% of the nation’s small, rural hospitals — many of which were operating at a deficit before the pandemic — jumped at the Medicare loans when the pandemic hit because they were the first funds available, said Maggie Elehwany, former vice president of government affairs for the National Rural Health Association.

Read the full article here.

Centers for Disease Control and Prevention (CDC) director Robert Redfield warned Congress this week that it could take six to nine months after approval to get enough people vaccinated to control the pandemic. President Trump has promised a vaccine fast, but Redfield said the U.S. will struggle to distribute an eventual vaccine. Redfield also offered a bridge between now and vaccine availability:

• “[F]ace masks are the most important, powerful public health tool we have.”
• “[W]e have clear scientific evidence they work, and they are our best defense.”
• “I might even go so far as to say that this face mask is more guaranteed to protect me against COVID-19 than when I take a COVID-19 vaccine, because the immunogenicity might be 70%, and if I don’t get an immune response, the vaccine’s not going to protect me. This face mask will.”
• “I do want to keep asking the American public to take the responsibility — particularly the 18- to 25-year-olds. … because we haven’t got the acceptance of personal responsibility that we need for all Americans to embrace this face mask.”

The Pennsylvania Department of State offers a consolidated list of licensure regulations that have been impacted by the COVID-19 pandemic. The list includes all pandemic actions taken by the state’s licensure boards and includes:

• Buprenorphine Treatment. Suspension of the initial medical history and physical examination requirement for Buprenorphine treatment extended for the duration of the disaster declaration
• CE Credits for Poll Work. Nursing Home Administrators, Physical Therapists, Social Workers, Marriage & Family Therapists, Professional Counselors, Speech-Language Pathologists and Audiologists can earn up to 2 hours of CE for serving as poll workers for the election

For a complete list of the licensure board actions during the pandemic, click here.

The Pennsylvania Department of Health released Health Alert 525-09-14: Guidance for Patients Under Quarantine After Exposure to SARS-CoV-2. If PA DOH or the local health department identifies that someone is a close contact to a person with COVID-19, the close contact must quarantine for 14 days from last contact, even if the person remains asymptomatic. A negative test result obtained while a close contact is under quarantine does not release the person from quarantine. Because infection can develop up to 14 days after exposure, persons with negative test results must still quarantine for the full 14 days. Patients being tested for SARS-CoV-2 infection must be instructed to isolate at home until results are received. Click here to access all of the 2020 health alerts, advisories and updates.

According to The Hill, the Problem Solvers Caucus, comprised of centrist Democrats and Republicans in the U.S. House, will propose a $1.5 trillion package that provides another round of stimulus checks, boosted unemployment insurance and much-needed aid for cities and states. This proposal is in response to the continued stalemate between the U.S. House and Senate and the White House around a fourth stimulus package. The proposed package does not include additional funding for FQHCs. Rep. Brian Fitzpatrick (R-Bucks) is the vice-chair of the caucus. Other members of the Pennsylvania delegation in the caucus include Rep. Chrissy Houlahan (D-Chester), Rep. Dan Meuser (R-Lebanon) and Rep. Lloyd Smucker (R-Lancaster).

On August 20, the U.S. Department of Agriculture notified states that pandemic electronic benefit transfer (P-EBT) benefits could be issued to schools that are not providing meal service due to the closure of the school for at least five days as long as benefits were issued by Sept. 30. P-EBT helps ensure that children can eat. Pennsylvania submitted its plan to the USDA’s Food and Nutrition Service for approval on Aug. 28 and last week learned the plan was denied. The PA Department of Human Services (DHS) would like to continue P-EBT for the entire 2021 school year, but cannot do so without Congressional reauthorization, as the program sunsets on Sept. 30. DHS is urging Congress to reauthorize P-EBT for the entire 2020-21 school year and to clearly state how benefits should be issued for hybrid and remote learning environments.