Update of COVID-19 Therapeutics from HHS/ASPR

We wanted to share an update from the Department of US Health and Human Services around policies related to allocation, distribution, and administration efforts surrounding the current monoclonal antibody therapeutics available to combat the COVID-19 pandemic.  

Beginning Monday, September 13th HHS made a change to their distribution process to coordinate through a state/territory-coordinated system.  The intent of this change is to maintain equitable distribution, both geographically and temporally providing states and territories with consistent, fairly distributed supply over the coming weeks and while the USG works to procure additional supply.  Key to this change is that administration site (i.e. providers) will not be able to order mAbs directly from the distributor and must work with their state/territory to access the supply.  

Weekly distribution amounts will be determined based on weekly reports of new COVID 19 cases and hospitalizations in addition to data on inventories.  Weekly distribution determinations posted on phe.gov/mabs

HHS Announced 60 Day Grace Period for PRF Reporting

In addition to making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic, in light of the challenges providers across the country are facing due to recent natural disasters and the Delta variant, HHS (Department of Health & Human Services) announced Friday a final 60-day grace period to help providers come into compliance with their PRF Reporting requirements if they fail to meet the deadline on September 30, 2021, for the first PRF Reporting Time Period.  While the deadlines to use funds and the Reporting Time Period will not change, HHS will not initiate collection activities or similar enforcement actions for noncompliant providers during this grace period.

New Provider Relief Funds available – $25.5 billion

The Biden-Harris Administration announced today that the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic.  This funding includes $8.5 billion in American Rescue Plan (ARP) resources for providers who serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients, and an additional $17 billion for Provider Relief Fund (PRF) Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic.  View the press release for the PRF Phase 4 here.  For more information on eligibility requirements and the application process for PRF Phase 4 and ARP Rural payments, visit: https://www.hrsa.gov/provider-relief/future-payments.

Covid-19 Community Vaccine Program

The Mississippi State Department of Health (MSDH) has launched a Covid-19 Community Vaccine Program, aimed at vaccinating home bound patients. MSDH is currently looking for providers in the following counties to participate in the program: Montgomery, Grenada, Jefferson, Carrol, Leflore, and Wilkinson.

If you are interested in becoming a CCVP provider, please view the following information: Covid-19 Community Vaccination Program (CCVP)

NRHA Events Going Virtual

As an organization serving and consisting of public health leaders, NRHA has a responsibility to abide by and serve as a model for proper health precautions. That is why we have made the difficult decision to shift the association’s Rural Health Clinic and Critical Access Hospital Conferences to a virtual environment.

The fourth wave of the COVID-19 pandemic is hitting harder than anyone expected. While Delta variant forecasts are difficult to project, the situation is unlikely to improve between now and this fall.

For these reasons, we ask for your patience as we transition our RHC and CAH Conferences away from our plans to host in Kansas City. As usual, you can register for these events at reduced virtual rates, and all content will be available Sept. 21-24 and on demand at your convenience for a full year.


View virtual rates here…

At NRHA, the health and well-being of our members and all rural Americans is our top priority. We do not want to risk contributing to the spread of this deadly virus, and we don’t want to place rural health care workers, hospitals, and health systems under any more pressure than they already face. 

We know it is not ideal, but virtual events allow NRHA to present – and you to experience – even more educational content than at an in-person event. NRHA will utilize the same platform as our 2021 Annual Rural Health Conference, by far our most intuitive and seamless virtual environment. 

Though this is certainly not what any of us had planned, we look forward to seeing everyone virtually this fall. Rural America is nothing if not resourceful, and together we will continue to overcome the challenges we face. 

How RHCs Should Be Reimbursed for Monoclonal Antibody Infusions

We have received several calls and e-mails in the last few weeks regarding monoclonal antibody infusions in the rural health clinic setting. Tommy Barnhart with the National Rural Health Association provided this breakdown of MA injection reimbursement.

Click here to view a CMS transmittal for freestanding RHCs issued 4/30/21 effective for cost reports ending after 3/31/2021. 

Among other things, it adds lines on Worksheet A specific to Covid vaccine administration (line 31.10) and monoclonal antibody (line 31.11) expenses and new columns on Worksheet B-1 to calculate reimbursement.  The calculation is similar to flu and pneumonia and reimbursed through the cost report in addition to the AIR.  For Covid and monoclonal antibody, this includes Medicare Advantage in addition to traditional Medicare.  As with flu and pneumonia, there is no method to bill the MAC for these services.  Hospital forms have not been adjusted yet but expect those to be done likewise soon.  FQHC forms have been updated similar to freestanding RHC. 

We will continue to work to improve the way that RHCs can bill for vaccine and monoclonal antibody infusions, especially during the critical time in our state’s healthcare system. Please contact us with any further questions.

Summary of the COVID-19 Emergency Temporary Standard (ETS) Rulemaking

On June 21, 2021, the Occupational Safety and Health Administration (OSHA) released an emergency temporary standard (ETS) rulemaking with the goal of protecting health care workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.  

As an ETS, the rule because effective when published on June 21, 2021.  Health care employers are required to be compliant with the sections of the rule on July 6, 2021, or July 21, 2021, depending on the provision.  

NRHA feels the timeline for compliance with this regulation is onerous.  Additionally, we believe the 916-page ETS is overly burdensome for rural providers, requiring health care employers to go above and beyond what many have already put in place following CDC guidelines such as social distancing barriers, patient screening, and a wholistic COVID-19 plan.  

Some requirements to note within the ETS include:  

  • Providers must develop and implement a COVID-19 plan  
  • Providers must limit and monitor points of entry to mitigate COVID-19 exposure  
  • Providers must ensure employees wear facemasks when indoors and when operating a vehicle with another person (this includes employees who are not directly caring for patients) and other restrictions on PPE  
  • Providers must require employees stay at least six feet apart from all other people when indoors except in situations where that is not possible 
  • Employer must install cleanable or disposable solid barriers at each fixed workstation located outside of direct patient care areas, where each employee is not able to be separated by all other people by at least six feet 
  • Provisions regarding proper ventilation with their heating, ventilation, and air conditioning (HVAC) systems to ensure that the amount of outside air circulated is maximized  

The ETS applies to a number of settings where suspected or confirmed COVID-19 patients are treated, including hospitals, home health care works, nursing homes, assisted living facilities, EM, and ambulatory care facilities.  It does not apply to settings where all employees are full vaccinated, non-employees are screened prior to entry and suspected or confirmed COVID-19 patients are not present.   

NRHA believes these regulations listed above will be particularly difficult for rural providers to comply with. Additionally, we have already heard from several members that they believe the facemask and social distancing requirements will run contrary to both the science and the current state and Federal guidelines for individuals who have been vaccinated. Further, implementing overly burdensome cleaning guidelines, installing physical barriers, and ensuring proper ventilation will be particularly difficult for rural providers already operating on slim margins. Health care providers could have used the PRF allocations to implement these kinds of regulations over the past 15-months, but instead OSHA implemented this rulemaking after the deadline for the majority of rural providers use of the funds.   

NRHA plans to submit comments on this ETS ahead of the July 21, 2021, deadline. In our comments, NRHA will urge OSHA to remove, or at a minimum delay, this regulation from taking effect. Health care providers have done an outstanding job of keeping their patients and employees safe throughout the COVID-19 pandemic. Adding a burdensome regulation like the ETS proposes will not protect patients or employees.  Rather it will pull limited staff and financial resources in directions that could be better used providing health care to patients during the ongoing pandemic. Further, NRHA believes the rule is being implemented at an unnecessary point in the pandemic. Providers have had COVID-19 protocols in place for over 15 months. Adding new regulations from OSHA at this time is not needed for patients and employers to feel safe in the health care setting.  

NRHA encourages members to comment on this regulation if you believe it will be overly burdensome to comply with, especially given the tight timeline turnaround. OSHA released a subsequent message saying they have determined that no changes to the ETS are necessary at this time, so we believe comments expressing the need for removal, or delay, of the regulation will be important to OSHA’s decision-making process. NRHA will share our comments for the regulation in the coming days so you can read them as a guidepost in crafting your own comments.  

You can find the rule posted on Regulations.gov here. Additionally, OSHA has posted related summaries, fact sheets, and compliance assistance materials and tools hereComments are due to the Federal Register by July 21, 2021.

Legislative and Policy Updates – June, 2021

The following represents various state and federal legislative and policy updates as of June 1, 2021.


State Update

Mississippi Medicaid has issued several policies that will affect rural clinics in Mississippi. Through an administrative procedures notice filing notice to the Secretary of State on May 20th, the notice highlights two main areas affecting clinics- an elimination of RHCs and FQHCs to perform EPSDT screening in the school setting, as well as a freeze of Medicaid payment rates. The latter of these is details on page 21 of the proposed Medicaid policy document under Rule 1.45: Reimbursement Methodology.

Given the potential impact that this may have with most Mississippi clinics, we highly encourage you to call-in and express comments during the open comment period on June 11, 2021 at 10 a.m. via the following telephone access information: 888-822-7517, access code 4282244.


Federal Updates

The Biden administration initially chose Memorial Day as the target date to decide which route to take on infrastructure: bipartisan or through reconciliation (the process to pass legislation in the Senate by 50 votes). On Thursday, a group of Senate Republicans announced a counterplan for $928 billion in infrastructure spending, much lower than the president’s $2.2 trillion plan. It is unclear which route the administration and Congress will take. NRHA continues to talk with offices on both sides of the aisle about the needs of rural providers. Key issues include the need for capital for rural hospitals, 100 percent broadband connectivity in rural areas, and the need for additional investment in the health workforce. You can read NRHA’s full letter to Congressional leadership here. NRHA will keep members up to date on infrastructure talks as they develop on Capitol Hill. 

Chiquita Brooks-LaSure Sworn in as CMS Administrator 

On Thursday, Chiquita Brooks-LaSure was sworn in as the Administrator of the Centers for Medicare and Medicaid Services (CMS).  She was confirmed by the full Senate on Tuesday by a vote of 55-44.

Senate HELP Committee Passes Rural MOMS Act

The Senate Committee on Health, Education, Labor, and Pensions (HELP) passed Senators Tina Smith (D-MN) and Lisa Murkowski’s (R-AK) Rural Maternal and Obstetric Modernization of Services (Rural MOMS) Act during this week’s executive session. Unfortunately, in rural America, pregnant women and new mothers have a significantly higher chance of dying from causes related to pregnancy and childbirth compared to their urban counterparts. This legislation provides needed investment in training and technology to offer greater maternal health services in rural America while taking significant strides to address the maternal mortality rate.

Important Federal Legislation to Watch

•          H.R. 341: Ensuring Telehealth Expansion Act of 2021- Williams (R-TX)

•          H.R. 769/S. 1491: Rural MOMS Act – Newhouse (R-WA); Smith (D-MN) 

•          H.R. 853: Closing Loopholes for Orphan Drugs Act – Welch (D-VT)

•          H.R. 1538: Binational Health Strategies Act of 2021 – Escobar (D-TX)

•          S. 104/H.R. 379: Improving Social Determinants of Health Act – Smith (D-MN); Barragan (D-CA)

•          S. 54: Strengthening America’s Health Care Readiness Act- Durbin (D-IL)

•          S. 368: Telehealth Modernization Act – Scott (R-SC)

•          S. 644/H.R. 1639: Rural Hospital Closure Relief Act – Durbin (D-IL); Kinzinger (R-IL)

•          H.R. 1887: Rural Hospital Support Act – Reed (R-NY)

•          H.R. 1783: Accessible, Affordable Internet for All Act – Clyburn (D-SC)

•          S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes – Thune (R-SD)

•          S. 924: Rural America Health Corps Act – Blackburn (R-TN)

•          H.R. 2228: To allow for payment of outpatient critical access hospital services furnished through telehealth under the Medicare program – Kildee (D-MI)

•          H.R. 3259/S. 586: NOPAIN Act – Sewell (D-AL); Capito (R-WV)

•          S. 999: Save Rural Hospitals Act of 2021 – Warner (D-VA)

•          S. 1024/H.R.2255: Healthcare Workforce Resilience Act – Durbin (D-IL); Schneider (D-IL)

•          S. 620: KEEP Telehealth Options Act of 2021 – Fischer (R-NE)

•          H.R. 2454: To amend title XVIII to strengthen ambulance services furnished under part B of the Medicare program – Sewell (D-AL)

•          S. 1512/H.R. 2903: CONNECT for Health Act – Schatz (D-HI); Thompson (D-CA)

•          S. 165/H.R. 588: Stopping the Mental Health Pandemic Act – Smith (D-MN); Porter (D-CA) 



Funding Opportunities

HRSA Releases Rural Health Clinic Vaccine Confidence Program NOFO

On May 4, the White House announced they will make over $100 million available to support rural health clinics across the country to support vaccine outreach in rural communities. The Health Resources and Services Administration (HRSA) has announced the availability of the notice of funding opportunity announcement titled the Rural Health Clinic (RHC) Vaccine Confidence Program. The purpose of the program is to support rural health clinics as they work towards improving vaccine confidence, counter vaccine hesitancy, and help with access to the vaccination in rural communities that are experiencing low COVID-19 vaccination rates. Eligible applicants include Medicare-certified RHCs and organizations that own and operate Medicare-certified RHCs. HRSA has streamlined the application process. Every eligible RHC that applies will be funded. For further information on the NOFO, please visit Grants.Gov and for additional information regarding the program, please email RHCVaxConfidence@hrsa.gov.

HRSA Community-Based Workforce to Increase Vaccine Access

HRSA expects 121 awards with total funding of $121 million to expand the public health workforce at the local level in response to COVID-19. This includes mobilizing community health workers, patient navigators, and social support specialists to conduct face-to-face outreach to community members. Eligible applicants are local and/or regional community-based organizations applying as a single entity or as a network of partnering organizations. Applications are due June 9.

New Funding Available for the HRSA Telehealth Technology-Enabled Learning Program

HRSA expects to make nine awards of up to $475,000 each to connect specialists at academic medical centers with primary care providers in rural areas to improve patient care in their communities via new funding for the administration’s Telehealth Technology-Enabled Learning Program. More specifically, these learning opportunities will address unmet needs for their target population, which could include populations who have historically suffered from poorer health outcomes. Applications from public, private, and nonprofit entities are due on June 25. 

FDA  Approves Storage of Pfizer Vaccine for Up to One Month

The Food and Drug Administration (FDA) updated its guidance for healthcare providers administering the vaccine and allows for undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in refrigeration for up to one month. The previous time span was up to five days. 

RHC Payment Change and Sequestration Delay

Beginning on April 1st the Rural Health Clinic (RHC) per visit upper payment limit increased from $87.52 to $100. The increased upper payment limit is a direct result of the payment changes included in Section 130 of the Consolidated Appropriations Act of 2021. Some Medicare Administrative Contractors have already sent out letters to RHCs informing them of the increased upper limit and how it will affect their All-Inclusive Rate payments.

Meanwhile, on Capitol Hill, the House is expected to pass legislation after they return from recess (April 12th) that includes a grandfathering fix for RHCs and delays the resumption of a 2% Medicare sequestration cut until the end of 2021 that affects all providers.  The likely vehicle to do this is H.R> 1868.

While H.R. 1868 is not yet law, the expectation that this bill will pass is so strong that CMS announced that they will temporarily hold claims with dates of service on or after April 1, 2021, pending Congressional Action. This includes RHC claims that would have otherwise been subject to the 2% sequester reduction.

For context, when COVID-19 began last year, Congress temporarily waived the standing 2% across-the-board reduction in Medicare reimbursement (the sequester) until the end of 2020, and then later through March 31, 2021. H.R. 1868 will now extend this waiver through the end of 2021.

Specifically, section 2 of the Senate-passed version of H.R. 1868 contains the RHC grandfathering fix which will:

– Fix the grandfathering date for under 50-bed hospital RHCs from December 31, 2019, to December 31, 2020;

– Allow under 50-bed hospital entities that submitted applications to become an RHC by December 31, 2020, to be grandfathered-in; and

– Establish a methodology for setting the upper payment limits for grandfathered RHCs that did not have reimbursement in 2020.