The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy, casirivimab and imdevimab, administered together, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. Casirivimab and imdevimab, administered together, may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the Emergency Medical System (EMS), as necessary. Review the Fact Sheet for Health Care Providers EUA of Casirivimab and Imdevimab regarding the limitations of authorized use when administered together.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA).

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Regeneron’s Antibody Casirivimab and Imdevimab (REGN-COV2) , EUA effective November 21, 2020.

Q0243:

Long descriptor: Injection, casirivimab and imdevimab, 2400 mg

Short descriptor: casirivimab and imdevimab

M0243:

Long Descriptor: intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

Short Descriptor: casirivi and imdevi infusion

Additional Resources:

• List COVID-19 monoclonal antibody infusion billing codes, payment allowances and effective dates
• Monoclonal Antibody COVID-19 Infusion Program Instruction
• CMS COVID-19 Vaccine Provider Toolkit

In line with USDA’s unwavering promise to serve America’s children well through school meal programs, the department today announced it will publish a proposed rule maintaining flexibility for schools to serve tasty meals their kids will be eager to eat. These proposed changes respond directly to the needs of nutrition professionals who are the experts on-the-ground, hearing from our children every day.

The proposed rule would maintain flexibility in USDA child nutrition program meal requirements related to milk, grains, and sodium, by:

• Allowing flavored, low-fat milk in the Child Nutrition Programs;
• Allowing half of the weekly grains offered through the school meal programs to be whole grain-rich; and
• Providing schools more time for gradual sodium reduction by retaining Sodium Target 1 through the end of SY 2023-2024, continuing to Target 2 in SY 2024-2025, and eliminating the Final Target.

Yesterday, USDA issued a separate rule as an administrative step to ensure the department’s procedural compliance with a court ruling regarding its 2018 final rule on child nutrition program flexibilities. Today’s rule proposes to restore the flexibilities included in the 2018 final rule. Despite this procedural formality, schools do not have to change their meals, thanks to the  meal pattern flexibilities USDA has already provided in all child nutrition programs through June 30, 2021, in response to the COVID-19 national emergency.

The proposed rule announced today will publish in the Federal Register on Nov. 25th, followed by a 30-day public comment period. USDA is committed to listening to and collaborating with customers, partners, and stakeholders to make these reforms as effective as possible, and encourages all those who are interested in school meals to share their comments and recommendations for improvement through regulations.gov.

For information on food insecurity in Pennsylvania throughout the pandemic, visit agriculture.pa.gov/foodsecurity.

Pennsylvania Agriculture Secretary Russell Redding announced that the CARES Act-funded Dairy Indemnity Program has distributed $7.6 million in direct relief payments to 1,550 dairy farmers in the commonwealth. Any dairy farmer who experienced losses due to discarded or displaced milk during the COVID-19 pandemic was eligible to apply.

“Early in the pandemic in Pennsylvania, many of our dairy farmers were forced to dump milk and faced extreme uncertainty due to rapidly changing markets,” said Redding. “In this season of thanks, we are grateful that the legislature saw and met the needs of Pennsylvania’s dairy farmers with this program. These dollars don’t stop at the farm gate. They come back in your communities through grocery stores, schools, food banks, and more.”

Senators Judy Schwank and Elder Vogel, chairs of the Senate Agriculture and Rural Affairs Committee, championed this CARES-Act funding for Pennsylvania’s dairy farmers and joined today’s announcement.

“The dairy indemnity program, funded by the CARES Act, was a great program to help 1,550 of our farmers weather COVID-19,” Schwank said. “But there are nearly 7,000 dairy farms in the Commonwealth. We have to recommit ourselves to doing everything we can to strengthen the industry.”

“During this difficult time, there was an even greater appreciation for the role dairy farmers plays in our economy and to the families of Pennsylvania,” said Vogel. “It is the Commonwealth’s most essential industry and providing the necessary state funding at this time is more critical than ever.”

To qualify for direct relief payments, farmer’s losses must have occurred between March 6, 2020 and September 30, 2020. Farmers were eligible for an immediate $1,500 in direct relief upon applying, followed by additional relief dollars with the remaining funds in the program.

Pennsylvania is home to nearly 7,000 dairy farms with an economic impact of $12 billion and more than 52,000 jobs. The commonwealth’s more than 500,000 cows produce more than 10.2 billion pounds of milk annually, ranking Pennsylvania seventh in the nation for total milk production.

Reminder: December 11 Deadline for 2021 Dairy Safety-Net Enrollment

The U.S. Department of Agriculture reminds dairy producers that the deadline to enroll in Dairy Margin Coverage (DMC) for calendar year 2021 is Friday, Dec. 11, 2020. USDA’s Farm Service Agency (FSA) opened DMC signup in October to help producers manage economic risk brought on by milk price and feed cost disparities.

For DMC enrollment, producers must certify with FSA that the operation is commercially marketing milk, sign all required forms, and pay the $100 administrative fee unless the dairy operation qualifies for a limited resource, beginning, socially disadvantaged, or military veteran farmers and ranchers waiver.

Producers interested in DMC have the option to select a $4.00 catastrophic level of coverage with no premium fee or they can choose to buy-up coverage where the premium is based on margin triggers between $4.50 and $9.50 on 5 to 95 percent of established production history.

To determine the appropriate level of DMC coverage for a specific dairy operation, producers can utilize the recently updated online dairy decision tool. The decision tool is designed to demonstrate the historical performance of DMC and assist producers with calculating total premium costs and administrative fees associated with participation in DMC. An informational video is available, too.

For more information, visit farmers.gov DMC webpage, or contact your local USDA Service Center. To locate your local FSA office, visit farmers.gov/service-center-locator.

The Centers for Medicare & Medicaid Services (CMS) outlined unprecedented steps to increase the capacity of the American health care system to provide care to patients outside a traditional hospital setting amid a rising number of coronavirus disease 2019 (COVID-19) hospitalizations across the country.

In March 2020, CMS announced the Hospitals Without Walls program, which provides broad regulatory flexibility that allowed hospitals to provide services in locations beyond their existing walls. Today, CMS is expanding on this effort by executing an innovative Acute Hospital Care At Home program, providing eligible hospitals with unprecedented regulatory flexibilities to treat eligible patients in their homes. CMS believes that treatment for more than 60 different acute conditions, such as asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease (COPD) care, can be treated appropriately and safely in home settings with proper monitoring and treatment protocols.

As part of Hospital Without Walls, CMS also previously announced regulatory flexibility that allowed Ambulatory Surgical Centers (ASCs) – facilities that normally provide same-day surgical care – the ability to be temporarily certified as hospitals and provide inpatient care for longer periods than normally allowed. Today, CMS is announcing an update to that regulatory flexibility, clarifying that participating ASCs need only provide 24-hour nursing services when there is actually one or more patients receiving care onsite.

A press release is attached and available here.

Frequently asked questions (FAQs) on the Acute Hospital Care At Home program are attached and available here.

FAQs on the ASC flexibilities announced today are attached and available here.

As part of NIOSH’s efforts to keep our stakeholders up to date on the CDC and NIOSH COVID-19 response, here is a summary of new information available.

• A new scientific brief highlights evidence that cloth masks help to block virus-carrying respiratory droplets from reaching others when the wearer has COVID-19. Cloth masks can also help block the amount of virus-carrying droplets that a mask wearer inhales if someone nearby is infected.
• The workplaces and businesses webpage was updated to provide one central location for all work-related COVID-19 resources.
• A new infographic provides tips to ensure that employers and employees are prepared to assist when a COVID-19 case is identified in the workplace. The infographic is a part of the recommendations provided for COVID-19 Case Investigation and Contact Tracking in Non-Healthcare Workplaces: Information for Employers.
• The critical infrastructure sector response planning webpage as updated to reflect new scientific evidence, evolving epidemiology, and the need to simplify the assessment of risk.

New school resources are also available:

The Cleaning, Disinfection, and Hand Hygiene in Schools toolkit is now available to aid school administrators as they consider how to protect the health, safety, and wellbeing of students, teachers, other school staff, families, and communities and prepare for educating students.

The school health personnel webpage provides information and resources to help school nurses and other healthcare personnel perform these new roles and responsibilities during the COVID-19 pandemic. Resources for self-care are also included.

On December 1, CMS released the annual Physician Fee Schedule (PFS) final rule, prioritizing CMS’ investment in primary care and chronic disease management by increasing payments to physicians and other practitioners for the additional time they spend with patients, especially those with chronic conditions. The rule allows non-physician practitioners to provide the care they were trained and licensed to give, cutting red tape so health care professionals can practice at the top of their license and spend more time with patients instead of on unnecessary paperwork. This final rule takes steps to further implement President Trump’s Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors including prioritizing the expansion of proven alternatives like telehealth.

“During the COVID-19 pandemic, actions by the Trump Administration have unleashed an explosion in telehealth innovation, and we’re now moving to make many of these changes permanent,” said HHS Secretary Alex Azar. “Medicare beneficiaries will now be able to receive dozens of new services via telehealth, and we’ll keep exploring ways to deliver Americans access to health care in the setting that they and their doctor decide makes sense for them.”

“Telehealth has long been a priority for the Trump Administration, which is why we started paying for short virtual visits in rural areas long before the pandemic struck,” said CMS Administrator Seema Verma. “But the pandemic accentuated just how transformative it could be, and several months in, it’s clear that the health care system has adapted seamlessly to a historic telehealth expansion that inaugurates a new era in health care delivery.”

Finalizing Telehealth Expansion and Improving Rural Health

Before the COVID-19 Public Health Emergency (PHE), only 15,000 Fee-for-Service beneficiaries each week received a Medicare telemedicine service. Since the beginning of the PHE, CMS has added 144 telehealth services, such as emergency department visits, initial inpatient and nursing facility visits, and discharge day management services, that are covered by Medicare through the end of the PHE. These services were added to allow for safe access to important health care services during the PHE. As a result, preliminary data show that between mid-March and mid-October 2020, over 24.5 million out of 63 million beneficiaries and enrollees have received a Medicare telemedicine service during the PHE.

This final rule delivers on the President’s recent Executive Order on Improving Rural Health and Telehealth Access by adding more than 60 services to the Medicare telehealth list that will continue to be covered beyond the end of the PHE, and we will continue to gather more data and evaluate whether more services should be added in the future. These additions allow beneficiaries in rural areas who are in a medical facility (like a nursing home) to continue to have access to telehealth services such as certain types of emergency department visits, therapy services, and critical care services. Medicare does not have the statutory authority to pay for telehealth to beneficiaries outside of rural areas or, with certain exceptions, allow beneficiaries to receive telehealth in their home. However, this is an important step, and as a result, Medicare beneficiaries in rural areas will have more convenient access to health care.

Additionally, CMS is announcing a commissioned study of its telehealth flexibilities provided during the COVID-19 PHE. The study will explore new opportunities for services where telehealth and virtual care supervision, and remote monitoring can be used to more efficiently bring care to patients and to enhance program integrity, whether they are being treated in the hospital or at home.

Payment for Office/Outpatient Evaluation and Management (E/M) and Comparable Visits

Last year, CMS finalized a historic increase in payment rates for office/outpatient face-to-face E/M visits that goes into effect in 2021. The Medicare population is increasing, with over 10,000 beneficiaries joining the program every day. Along with this growth in enrollment is increasing complexity of beneficiary health care needs, with more than two-thirds of Medicare beneficiaries having two or more chronic conditions. Increasing the payment rate of E/M office visits recognizes this demand and ensures clinicians are paid appropriately for the time they spend on coordinating care for patients, especially those with chronic conditions. These payment increases, informed by recommendations from the American Medical Association (AMA), support clinicians who provide crucial care for patients with dementia or manage transitions between the hospital, nursing facilities, and home.

Under this final rule, CMS continues to prioritize this investment in primary care and chronic disease management by similarly increasing the value of many services that are similar to E/M office visits, such as maternity care bundles, emergency department visits, end-stage renal disease capitated payment bundles, and physical and occupational therapy evaluation services. These adjustments ensure CMS is appropriately recognizing the kind of care where clinicians need to spend more face-to-face time with patients.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” Administrator Verma added. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In addition to the increase in payment for E/M office visits, simplified coding and documentation changes for Medicare billing for these visits will go into effect beginning January 1, 2021. The changes modernize documentation and coding guidelines developed in the 1990s, and come after extensive stakeholder collaboration with the AMA and others. These changes will significantly reduce the burden of documentation for all clinicians, giving them greater discretion to choose the visit level based on either guidelines for medical decision-making (the process by which a clinician formulates a course of treatment based on a patient’s information, i.e., through performing a physical exam, reviewing history, conducting tests, etc.) or time dedicated with patients. These changes are expected to save clinicians 2.3 million hours per year in administrative burden so that clinicians can spend more time with their patients.

Professional Scope of Practice and Supervision

As part of the Patients Over Paperwork Initiative, the Trump Administration is cutting red tape so that health care professionals can practice at the top of their license and spend more time with patients instead of on unnecessary paperwork. The PFS final rule makes permanent several workforce flexibilities provided during the COVID-19 PHE that allow non-physician practitioners to provide the care they were trained and licensed to give, without imposing additional restrictions by the Medicare program.

Specifically, CMS is finalizing the following changes:

• Certain non-physician practitioners, such as nurse practitioners and physician assistants, can supervise the performance of diagnostic tests within their scope of practice and state law, as they maintain required statutory relationships with supervising or collaborating physicians.
• Physical and occupational therapists will be able to delegate “maintenance therapy” – the ongoing care after a therapy program is established – to a therapy assistant.
• Physical and occupational therapists, speech-language pathologists, and other clinicians who directly bill Medicare can review and verify, rather than re-document, information already entered by other members of the clinical team into a patient’s medical record. As a result, practitioners have the flexibility to delegate certain types of care, reduce duplicative documentation, and supervise certain services they could not before, increasing access to care for Medicare beneficiaries.

For More Information:

• Final Rule
• Physician Fee Schedule Final Rule fact sheet
• Quality Payment Program Final Rule fact sheet and FAQs
• Medicare Diabetes Prevention Program fact sheet