Agency outlines flexibilities to maximize Acute Hospital Care at Home, Ambulatory Surgical Centers to decompress hospitals treating COVID-19 patients

The Centers for Medicare & Medicaid Services (CMS) outlined unprecedented comprehensive 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. These flexibilities include allowances for safe hospital care for eligible patients in their homes and updated staffing flexibility designed to allow ambulatory surgical centers (ASCs) to provide greater inpatient care when needed. Building on CMS’s previous actions to expand the availability of telehealth across the nation, these actions are aimed at allowing health care services to be provided outside a hospital setting while maintaining capacity to continue critical non-COVID-19 care, allowing hospitals to focus on the increased need for care stemming from public health emergency (PHE).

“We’re at a new level of crisis response with COVID-19 and CMS is leveraging the latest innovations and technology to help health care systems that are facing significant challenges to increase their capacity to make sure patients get the care they need,” said CMS Administrator Seema Verma. “With new areas across the country experiencing significant challenges to the capacity of their health care systems, our job is to make sure that CMS regulations are not standing in the way of patient care for COVID-19 and beyond.”

Acute Hospital Care at Home

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. This program was developed to support models of at-home hospital care throughout the country that have seen prior success in several leading hospital institutions and networks, and reported in academic journals, including a major study funded by a Healthcare Innovation Award from the Center for Medicare and Medicaid Innovation (CMMI).

The program clearly differentiates the delivery of acute hospital care at home from more traditional home health services. While home health care provides important skilled nursing and other skilled care services, Acute Hospital Care at Home is for beneficiaries who require acute inpatient admission to a hospital and who require at least daily rounding by a physician and a medical team monitoring their care needs on an ongoing basis.

To support these efforts, CMS has launched an online portal https://qualitynet.cms.gov/acute-hospital-care-at-home to streamline the waiver request process and allow hospitals and healthcare systems to submit the necessary information to ensure they meet the program’s criteria to participate. CMS will also closely monitor the program to safeguard beneficiaries by requiring hospitals to report quality and safety data to CMS on a frequency that is based on their prior experience with the Hospital At Home model.

Ambulatory Surgical Center Flexibility

As part of Hospital Without Walls, CMS also previously announced regulatory flexibility that allowed 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, with the appropriate staffing in place. ASCs are normally subject to a requirement that patients only remain in their care for less than 24 hours or require admission to a regular hospital.

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 patient receiving care onsite. The program change provides ASCs enrolled as hospitals the ability to flex up their staffing when needed and provide an important relief valve in communities experiencing hospital capacity constraints, while not mandating nurses be present when no patients are in the ASC. The flexibility is available to any of the 5732 ASCs throughout the country seeking to participate and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative. CMS expects this flexibility will allow these and additional ASCs enrolled as hospitals to serve as an added access point that will allow communities to maintain surgical capacity and other life-saving non-COVID-19, like cancer surgeries. Allowing these types of treatments to occur in designated ASCs enrolled as hospitals while hospitals are managing any surges of COVID-19 would allow vulnerable patients to receive this needed care in settings without known COVID-19 cases.

The announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19. CMS has expanded the scope of Medicare telehealth to allow Medicare beneficiaries across the country to receive telehealth services from any location, including their homes. CMS also added over 135 services such as emergency department visits, initial inpatient and nursing facility visits, and discharge day management services, that could be paid when delivered by telehealth. The flexibilities announced today, and the aggressive action taken by CMS to remove barriers to telehealth, ensure patients and providers have options when receiving and providing care given the challenges and additional stress placed on hospitals and the health care system during the COVID-19 PHE.

To view the Acute Hospital Care At Home initiative and application, please visit: CMS’: https://qualitynet.cms.gov/acute-hospital-care-at-home

For more on the ambulatory surgical center flexibilities, please see: https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/guidance-processing-attestation-statements-ambulatory-surgical-centers-ascs-temporarily-enrolling

To view comments from health systems participating in the Acute Hospital Care at Home, please visit: https://www.cms.gov/files/document/what-are-they-saying-hospital-capacity.pdf

Link to FAQs:
https://www.cms.gov/files/document/covid-hospital-without-walls-faqs-ascs.pdf 

https://www.cms.gov/files/document/covid-acute-hospital-care-home-faqs.pdf

As Pennsylvania experiences a resurgence of COVID-19 cases with significantly higher daily case counts than in the spring and hospitalizations on the rise, the Pennsylvania Governor Wolf’s Administration has identified four new mitigation efforts, which Secretary of Health Dr. Rachel Levine announced on November 17, 2020.

“It is our collective responsibility to protect our communities and our most vulnerable Pennsylvanians from COVID-19 and to continue to work together to get through this pandemic. These targeted mitigation efforts, combined with existing ones, are paramount to saving lives and protecting our economy,” Gov. Wolf said. “The administration will continue to monitor the risks posed by COVID-19 across the commonwealth and will reinstate or institute new targeted mitigation tactics as necessary.”

The efforts announced include:

Protecting Our Health Care System

Dr. Levine issued a memorandum to acute care hospitals outlining expectations to care for Pennsylvanians who need care during the pandemic.

Hospitals are to work through the established health care coalitions and other partnerships to prepare for how they will support one another in the event that a hospital becomes overwhelmed during the pandemic. Hospitals should also be working to move up elective procedures necessary to protect a person’s health and prepare to suspend them if our health care system becomes strained.

Restrictions on elective surgeries put into effect in March and lifted in April were to help with both PPE and bed capacity and were considered successful.

Hospitalizations are increasing, as are ICU patients, and according to modeling from the Institute of Health Metrics and Evaluation, which does not take into account hospitalizations from influenza, Pennsylvania will run out of intensive care beds in December if ICU admissions continue at the current rate.

The same modeling indicates we will have sufficient medical-surgical beds with some uncertainty as to capacity from region to region.

Traveler Testing

Dr. Levine issued an order requiring anyone who visits from another state to have a negative COVID-19 test within 72 hours prior to entering the commonwealth.

If someone cannot get a test or chooses not to, they must quarantine for 14 days upon arrival in Pennsylvania.

Pennsylvanians visiting other states are required to have a negative COVID-19 test within 72 hours prior to their return to the commonwealth or to quarantine for 14 days upon return to Pennsylvania.

This order, which takes effect on Friday, November 20, does not apply to people who commute to and from another state for work or medical treatment.

Strengthened Masking Order

Dr. Levine first issued a masking order on April 15. The order signed today strengthens this initial order with these inclusions:

• Masks are required to be worn indoors and outdoors if you are away from your home.
• When outdoors, a mask must be worn if you are not able to remain physically distant (at least 6 feet away) from someone not in your household the entire time you are outdoors.
• When indoors, masks will now be required even if you are physically distant from members not in your household. This means that even if you are able to be 6 feet apart, you will need to wear a mask while inside if with people other than members of your household.
• This order applies to every indoor facility, including homes, retail establishments, gyms, doctors’ offices, public transportation, and anywhere food is prepared, packaged or served.

Colleges and Universities

The departments of Health and Education issued recommendations for colleges and universities to implement a testing plan for when students return to campus following the holidays.

These recommendations include establishing routine protocols for testing.

Colleges and universities should have adequate capacity for isolation and quarantine and should be prepared to enforce violations of established policies such as mask wearing and physical distancing.

Every college and university should test all students at the beginning of each term, when returning to campus after a break and to have regular screening testing throughout the semester/term.

“We must remain united in stopping COVID-19,” Dr. Levine said. “Wear a mask, wash your hands, stay apart and download the COVID Alert PA app. If you test positive, please answer the call of the case reviewer and provide information that can help protect others. It’s the selfless, right thing to do.”

From the American Hospital Association (AHA)

The U.S. Department of Health and Human Services (HHS) issued two important clarifications related to Provider Relief Fund (PRF) reporting.

First, HHS had previously stated that providers could claim only the value of depreciation for COVID-19-related capital purchases with useful lives of more than 12 months. However, at the AHA’s urging, the agency today stated that expenses for capital equipment, facilities projects and inventory may be fully expensed in cases where the purchase was directly related to the prevention, preparation for and response to the SARS-CoV-2 coronavirus. HHS provides several examples of such purchases, including:

• upgrading heating, ventilation and air conditioning systems to support negative pressure units;
• retrofitting COVID-19 units;
• enhancing or reconfiguring intensive care unit capabilities;
• leasing or purchasing temporary structures to screen and/or treat patients; and
• leasing permanent facilities to increase hospital capacity.

Second, HHS clarified that providers’ reporting of net patient revenue should NOT include any payments received from, or any payments made to, third parties that relate to care not provided in 2019 or 2020. The AHA had raised concerns with HHS about including in hospital reporting any Medicaid payments that have been made to settle years-old legal disputes over the program’s construction.

The AHA sent an alert to the field today on these, and other PRF advocacy issues. We will continue to encourage Congress to address our outstanding concerns.

Background
The Coronavirus Aid, Relief, and Economic Security (CARES) Act and Paycheck Protection Program and Health Care Enhancement Act included $175 billion in the Public Health and Social Services Emergency Fund to reimburse health care providers for health care-related expenses or lost revenues not otherwise reimbursed that are attributable to COVID-19. In order to accept these funds, recipients agreed to Terms & Conditions, which require compliance with reporting requirements as specified by HHS.

Further Questions
If you have questions, please contact AHA at 800-424-4301.

Pennsylvania Secretary of Health Dr. Rachel Levine urged Pennsylvanians to take COVID-19 and food safety precautions as they plan Thanksgiving celebrations during the holiday.

“The holidays are a time for togetherness, but this year, we must rethink what that looks like,” Secretary of Health Dr. Rachel Levine said. “This Thanksgiving, choose to celebrate with the people in your household and virtually connect with your loved ones. If you plan to leave your home to celebrate the holiday, please follow the travel mitigation order, wear a mask and stay six feet apart from others. Weather-permitting, sit outside and enjoy the day. Do whatever you can to limit the spread of COVID-19 at this critical point of the pandemic.”

The travel mitigation order goes into effect at 12:01 a.m. on November 20, 2020 and shall remain in effect until further notice.

The U.S. Centers for Disease Control and Prevention (CDC) recommends keeping anyone who is not preparing food out of the kitchen for COVID-19 and food safety reasons. Use single-use options like salad dressing and condiment packets. If you must attend a gathering, take your own food, drinks, cups, plates, and utensils.

As part of your celebration preparations, Pennsylvanians are encouraged to join the more than 528,000 residents who have already downloaded and use COVID Alert PA, the free mobile app offered by the Department of Health that is designed to help reduce the spread of COVID-19. The app uses Bluetooth Low Energy (BLE) technology and the exposure notification system developed by Apple and Google to help notify and give public health guidance to anyone who may have been in close contact with a person who has tested positive for COVID-19. Since the app only uses Bluetooth technology, it cannot and will not collect a user’s location data.

COVID Alert PA works in Pennsylvania, and several other locations in the United States including Delaware, Nevada, New Jersey, New York, North Carolina, North Dakota, Washington D.C., Wyoming, and some parts of California.

“We are seeing our highest case counts of the pandemic across Pennsylvania,” Dr. Levine said. “As I have said many times, the virus knows no boundaries, even between family members. It is imperative that everyone follows the safety measures laid out throughout the pandemic to protect themselves, loved ones, and all Pennsylvanians. In addition to COVID-19, practice food safety, especially when cooking the traditional Thanksgiving turkey.”

Further CDC cooking recommendations include thawing your turkey in the refrigerator in a container, leak-proof plastic bag in a sink of cold water, or in the microwave following the microwave oven manufacturer’s instructions. Never thaw your turkey by leaving it out on the counter. Remember that raw poultry can contaminate anything it touches with harmful bacteria. Bacteria can grow rapidly in the “danger zone” between 40°F and 140°F.

Cook your turkey thoroughly at an oven temperature of at least 325°F. It is not finished cooking until the food thermometer reaches a safe internal temperature of 165°F. Also, cook stuffing separately from the turkey and put the stuffing in the turkey just before placing the turkey in the oven to ensure the stuffing is thoroughly cooked.

For fire safety tips during Thanksgiving, click here.

Masks must be worn outdoors when park visitors are unable to adequately social distance

Pennsylvania Department of Conservation and Natural Resources (DCNR) Secretary Cindy Adams Dunn announced changes to operating procedures for state park and forest facilities that will require out-of-state visitors to comply with orders intended to prevent the spread and mitigate the impacts of COVID-19.

“Since the beginning of efforts to address the pandemic we have kept our state park and forest lands open to all so that people can safely enjoy outdoor recreation as a way to maintain positive physical and mental health, and that will continue to be the case,” Dunn said. “We are making some changes to our overnight stays for out-of-state-visitors and our programming to help decrease the spread of COVID-19.”

For the safety of visitors and staff, DCNR will be requiring guests to cancel and refunds will be issued if they are unable to honor mitigation efforts:

• Anyone who visits from another state must have a negative COVID-19 test within 72 prior to entering the commonwealth;
• If someone cannot get a test or chooses not to, they must quarantine for 14 days upon arrival in Pennsylvania before visiting a state park or forest; and
• Pennsylvanians visiting other states are required to have a negative COVID-19 test within 72 hours prior to their return to the commonwealth or to quarantine for 14 days upon return.

Out-of-state visitors cannot use state park overnight facilities to meet the 14-day quarantine requirement. Out-of-state residents visiting for the day also must comply with the mitigation efforts.  Visitors who don’t comply may be fined between $25 and $300.

Visitor center exhibit halls and interpretive areas will be closed, and all indoor programs will be canceled. Restrooms will continue to be available.

Masks are required to be worn:

• In park and forest offices;
• In any other indoor public space including restrooms;
• During both indoor and outdoor special events and gatherings; and
• Outdoors when visitors are unable to adequately social distance.

All outdoor environmental education and recreation programs will be limited to 20 people, to include staff and volunteer leaders. Masks must be work by all participants, and services will be denied if visitors cannot comply.

These will remain in effect until at least January 15, 2021.

Dunn noted that visits to Pennsylvania state parks have increased by more than a million visitors a month since the start of mitigation efforts, and that interest is expected to hold strong through the winter and spring.

“We encourage people to embrace being active outdoors, even in the winter, because there are so many benefits associated with enjoying nature,” Dunn said. “With the appropriate clothing and preparedness, winter is among the most beautiful and peaceful times in our parks and forests.”

To help avoid exposure to COVID-19 and still enjoy the outdoors:

• Don’t hike or recreate in groups – go with those under the same roof, and adhere to social distancing (stay 6 feet apart)
• Take hand sanitizer with you and use it regularly
• Avoid touching your face, eyes, and nose
• Cover your nose and mouth when coughing and sneezing with a tissue or flexed elbow
• If you are sick, stay home

Visitors can help keep state parks and forest lands safe by following these practices:

• Avoid crowded parking lots and trailheads
• Bring a bag and either carry out your trash or dispose of it properly
• Clean up after pets
• Avoid activities that put you at greater risk of injury, so you don’t require a trip to the emergency room

Pennsylvania has 121 state parks and 20 forest districts, and they are all open year round.

Information about state parks and forests is available on the DCNR website. Updates also are being provided on DCNR’s Facebook and Twitter accounts.

(As prepared for delivery – November 19, 2020)

Thank you. It’s a pleasure to speak to you on this tenth annual Rural Health Day. Let me start by thanking all of you on the frontlines for your hard work and dedication at this difficult time in history. It’s not lost on me how much rural providers have sacrificed. You are heroes in this war. Coronavirus has not spared any part of the world, and it has been particularly challenging for rural providers, which already faced considerable difficulties going into this pandemic.

The good news is that there is light at the end of the tunnel. Recent news about impending vaccines and new treatments is heartening. Life will eventually return to normal. As we face many difficult days ahead and all the challenges of immunizing a nation, I am also encouraged by the progress CMS has made in addressing some of the most critical rural health issues.

During my first year at CMS, I traveled to a rural health center and even visited the rural health association headquarters in Kansas. Coming from Indiana I had some familiarity with rural health care, but I am indebted to those who have continued to educate me about the issues rural communities face.

I learned about the many burdensome CMS regulations that may make sense in an urban community but don’t take into account the unique challenges in rural communities.  Rural Americans might live a long distance from the closest healthcare providers. These providers in turn often have limited resources and tight profit margins due to low patient volume, making it difficult to maintain robust workforces. These problems result in a systemically fragmented rural healthcare system, limited access to important specialty services, and disproportionately poor health outcomes for 60 million of our fellow Americans.

And that’s why I made rural health one of CMS’ top strategic initiatives. Over the past 4 years, we worked across the entire agency in every department to address rural health challenges. This represented a departure from established practice, as rural America’s pressing healthcare problems have been largely ignored for too long. I am proud of what the CMS team has accomplished. Their efforts have laid the foundation for rethinking rural health across the country.

During my time in office, CMS has constantly sought to bring the principles of the free market and competition to bear on the many areas of the healthcare system we oversee. We have had many successes in that effort, including some that affect rural areas directly. For example, when we came into office, insurers were fleeing the Exchanges. By 2018, 50 percent of counties in America – the majority of which are rural – had the non-choice of just one health insurer in their exchange; today, that number has plummeted to 9 percent.  And our changes to Medicare Advantage have increased plan options  for our beneficiaries, many of whom who have historically enjoyed limited choice due to anemic market competition. In 2021, Medicare beneficiaries in rural areas will have more than double the plan options they had in 2017.

That’s because we have given plans in Medicare Advantage – the privately administered branch of the Medicare program – flexibility and incentives to design supplemental benefits, including transportation and meal delivery that can help keep rural patients healthy.  We recently allowed Medicare Advantage plans to count telehealth providers in certain specialty areas – such as Dermatology, Psychiatry, Cardiology, and more – toward our network adequacy requirements. This increased flexibility has allowed them to assemble more robust health care provider networks in rural areas using telehealth.

But the fact remains: compared to their urban and suburban counterparts, rural areas present a special challenge for a market-based approach to healthcare policy. Infusing competitive forces is more complicated – sometimes downright impossible – given the unique obstacles rural areas face.

From the beginning, we have sought to address these problems by leveraging innovation and the transformative power of technology. Our historic work to promote the seamless and secure flow of medical records is a game changer for virtually every American, but it represents a particularly important breakthrough for rural Americans. Access to electronic medical information removes geographic barriers that prevent them from accessing the most up to date medical providers, research studies, and other services that typically cluster around dense urban areas.

We expanded telehealth because of its potential for rural areas where transportation over long distances can be difficult and providers are often in short supply. Starting in 2017, we allowed for short virtual check-ins with patients in their home and expanded the number of services that could be provided via telehealth, benefits that predate and will outlast the pandemic.

During the pandemic itself, we dramatically accelerated the telehealth expansion to help patients under stay-at-home orders receive care. At President Trump’s direction, we got rid of various restrictive regulations, including those that prevented telehealth from being furnished in people’s homes, including nursing homes.

We also expanded the types of providers that can provide telehealth and removed face-to-face requirements for certain types of care. Finally, we added over 135 telehealth services, such as emergency department visits, mental healthcare, and eye exams.

Just a few months ago, thanks to a groundbreaking Executive Order from President Trump, we proposed to make many of these flexibilities permanent, including prolonged office visits, mental health services, and more. We’ve proposed extending still others, such as lower level emergency department visits, psychological testing services, and more, beyond the end of the public health emergency. The result is a veritable revolution in healthcare delivery that will be a boon for rural patients.

Before moving on from this subject, it’s important to understand that our regulatory authority is largely limited specifically to telehealth services. We cannot make telehealth available permanently outside of rural areas, permanently expand the list of providers authorized to provide it, nor allow patients to receive telehealth services from their homes. Congress, then, has an essential role to play in following through on this historic opportunity. Without a change to the statute, telehealth will eventually revert to a more limited benefit that cannot be utilized from a patient’s home. In an earlier age, doctors commonly made house calls. Congress has the opportunity bring the reinvigoration of that tradition across the finish line.

In addition, just last year, to address disparities in Medicare payment among rural and urban hospitals, we boosted Medicare payments for many rural hospitals, to bring payments on par with those in urban areas. This is helping hospitals improve their financial sustainability and attract talent, improving access in rural America.

Reducing regulatory burden has also been a key focus. We have given hospitals greater flexibility on physician supervision requirements for certain types of hospital services and eased Medicare requirements so practitioners like physician assistants and nurse practitioners can independently provide more services so long as it’s within their scope of practice. The telehealth executive order I mentioned a moment ago also directed CMS to propose extending a pandemic flexibility that allowed physicians to virtually supervise their staff as they provide care to patients. Thanks to these reforms, rural hospitals can make the most of often limited workforces while maintaining patient safety.

To further ease the burden on physicians of all stripes, we have reformed their quality program and empowered them to pick the metrics most relevant to their specialty or the types of patients they see, rather than overloading them with largely irrelevant measures. Rural providers, often stretched thin, have benefitted tremendously from these reforms with more than 98 percent of eligible clinicians in rural practices participating as of 2018. Yet more simplifications lie in store.

These reforms are significant and tangible, but our most significant move is aimed at a more comprehensive reboot strategy for rural health.  Because without it, the longstanding, fundamental issues remain.

Most recently, we announced a new avenue for local and rural communities to take an active role in the transformation of their care. Called the Community Health Access and Rural Transformation model, or CHART, it represents a more flexible, grassroots approach to rural healthcare delivery than the top-down, one-size-fits-all approach that has failed rural Americans for so long.

Specifically, CHART would provide upfront funding to up to fifteen lead organizations that would bring together local parties – state Medicaid agencies and commercial payers, local hospitals, clinics, and other providers. These organizations would be eligible to receive upfront infrastructure investments, in grants of up to $5 million each for a total rural investment of $75 million, with which to organize the healthcare delivery system that works best for them. That may include explore transitioning to a “hub and spoke” model, in which one relatively large hospital serves as a kind of command and control center for smaller, more limited provider types.  It may involve reducing services for some hospitals and adding more for others, like maternity and home health.  It allows communities to think about what might work best for them.

It also requires rural hospitals to move to a stable, predictable, value-based payment and away from the current erratic, volume-based system that often doesn’t work for rural providers with low patient volume. It represents the first steps in a radical rethinking of how we pay for care in rural communities.  Contrary to the stale approach that has prevailed for so long, simply throwing more money at the problem is not enough. In some cases, funding increases may indeed be necessary, but how we pay is just as important as how much we pay.  All reimbursement systems should be structured to create incentives to produce better outcomes for patients.

Finally, we have paired these payment reforms with unprecedented regulatory flexibilities and program waivers for which rural providers have been asking for years. Specifically, the model waives certain conditions of participation in our programs, allowing hospitals to reduce unnecessary overhead costs while maintaining their status as hospitals or critical-access hospitals. Organizations can also employ value-based incentives such as reducing or waiving Part B co-insurance amounts to promote high-value preventive care.

In sum, the model’s seed funding, combined with the regulatory flexibilities and technical support will give rural providers what they have never had enough of before: breathing room to provide high-quality care to rural patients. In the months and years to come, CHART promises finally to deliver the wholesale transformation rural healthcare has needed for so long. If these local ventures fulfill their potential, they may serve as models for rural areas throughout the country.

Too often, policymakers have placated rural Americans with token solutions that fail to advance the systemic, fundamental transformation necessary to tackle these pervasive problems. Under our watch, that wildly insufficient approach has gone by the wayside. I am incredibly grateful to and proud of the CMS team that has spearheaded these reforms.

We have gone beyond merely tinkering around the edges of policy in favor of lasting, transformative change.  We have disrupted the status quo for sake of the American patient and thought big and acted boldly on issue after issue. Rural Americans are already experiencing the improvements brought by our reforms, but their beneficial effects will be felt in rural areas for years to come. Thank you.

Coverage Available at No Cost to Beneficiaries Across Variety of Settings in Health Care System

CMS announced that starting November 10, Medicare beneficiaries can receive coverage of monoclonal antibodies to treat COVID-19 with no cost-sharing during the Public Health Emergency (PHE). CMS’ coverage of monoclonal antibody infusions applies to bamlanivimab, which received an Emergency Use Authorization (EUA) from the FDA on November 9.

“Today, CMS is announcing a historic, first-of-its kind policy that drastically expands access to COVID-19 monoclonal antibodies to beneficiaries without cost sharing,” said CMS Administrator Seema Verma. “Our timely approach means beneficiaries can receive these potentially life-saving therapies in a range of settings – such as in a doctor’s office, nursing home, infusion centers, as long as safety precautions can be met. This aggressive action and innovative approach will undoubtedly save lives.”

CMS anticipates that this monoclonal antibody product will initially be given to health care providers at no charge. Medicare will not pay for the monoclonal antibody products that providers receive for free but this action provides for reimbursement for the infusion of the product. When health care providers begin to purchase monoclonal antibody products, Medicare anticipates setting the payment rate in the same way it set the payment rates for COVID-19 vaccines, such as based on 95% of the average wholesale price for COVID-19 vaccines in many provider settings. CMS will issue billing and coding instructions for health care providers in the coming days.

CMS anticipates the announcement will allow for a broad range of providers and suppliers, including freestanding and hospital-based infusion centers, home health agencies, nursing homes, and entities with whom nursing homes contract, to administer this treatment in accordance with the EUA, and bill Medicare to administer these infusions.

Under section 6008 of the Families First Coronavirus Response Act (FFCRA), state and territorial Medicaid programs may receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP), through the end of the quarter in which the COVID-19 PHE ends. A condition for receipt of this enhanced federal match is that a state or territory must cover COVID-19 testing services and treatments, including vaccines and their administration, specialized equipment, and therapies for Medicaid enrollees without cost sharing. This means that this monoclonal antibody infusion is expected to be covered when furnished to Medicaid beneficiaries, in accordance with the EUA, during this period, with limited exceptions.

View the Monoclonal Antibody COVID-19 Infusion Program Instruction.

The presidential election offers plenty of evidence that ignoring the coronavirus won’t make it go away.

Last week, while most of us focused on the race for the White House, the number of Covid-19 infections in rural counties grew by 30% and set a record for the number of new cases for the seventh consecutive week. There were 144,043 new infections in rural counties last week, up from about 110,000 the week before.

Also last week, another 97 rural counties were added to the red-zone list, bringing the total to 1,599, or four out of five of all nonmetropolitan counties. (This article using nonmetropolitan counties as synonymous with rural.)

Red-zone counties have a new infection rate of 100 or more cases in one week per 100,000 residents. The Trump administration’s White House Coronavirus Task Force says that red-zone counties need to enact tougher measures to control the virus.

The current surge originated in rural areas two months ago and more recently has spread into metropolitan counties. Previously, metropolitan counties had their worst new infection rates in July. But those counties surpassed those summer peaks for the past two weeks.

Here are other facts from last week’s analysis, which covers Sunday to Saturday, November 1 to 7.

• Rural counties had 1,873 Covid-19 related deaths last week, an increase of 20% from the previous week, and a new record. About 29% of new U.S. deaths occurred among rural residents, who constitute about 14% of the U.S. population.
• This fall’s surge has created a new class of rural hotspots. One quarter of rural counties (479) have one-week infection rates of at least 500 new cases per 100,000 residents — five times the red-zone infection level. Fourteen percent of metropolitan counties (141) meet that criterion. As the map below shows, these hotspot counties are primarily in the Upper Midwest, Great Plains, and the Intermountain region of that includes Montana, Wyoming, and Idaho.

Read more.

As Pennsylvania continues to combat COVID-19 and we enter cold and flu season, the most important step in preventing sickness is following healthy habits. These best practices limit the spread of germs for yourself and others.

Download the COVID Alert PA App

The COVID Alert PA app notifies you if you have had a potential exposure to someone who has tested positive for COVID-19. The app works by using anonymous Bluetooth technology that identifies other devices with the app in your proximity. When an app user who was near you reports they have a positive COVID-19 diagnosis, you may receive an alert, depending on the date, how long you were exposed and how close you were to the other person. It does not track your location or store your personal information.

The app also includes an interactive COVID-19 symptom checker, updates on the latest public health data about COVID-19 in PA and advice for what to do if you have a potential exposure to COVID-19.

Learn more and download now. The more Pennsylvanians that download the app, the more successful we will be in stopping the spread of the virus.

Mask Up

In Pennsylvania, masks must be worn whenever anyone leaves home. Masks are mandatory in all public spaces. Members of the public should wear homemade cloth or fabric masks and save surgical masks and N95 respirators for health care workers and first responders.

Remember this saying: “My mask protects you, your mask protects me.” 

Social Distance

It’s important to keep a safe space between yourself and other people who are not from your household. To practice social or physical distancing, stay at least 6 feet from other people who are not from your household in both indoor and outdoor spaces.

Washing your hands is one of the most important steps you can take in staying healthy. When you wash, make sure you:

1. Wet your hands with clean, running water (warm or cold), turn off the tap, and apply soap.
2. Lather your hands by rubbing them together with the soap. Lather the backs of your hands, between your fingers, and under your nails.
3. Scrub your hands for at least 20 seconds. Need a timer? Hum the “Happy Birthday” song from beginning to end twice.
4. Rinse your hands well under clean, running water.
5. Dry your hands using a clean towel or air dry them.

Washing hands with soap and water is the best way to get rid of germs in most situations. If soap and water are not readily available, you can use an alcohol-based hand sanitizer that contains at least 60 percent alcohol.

Avoid Touching Your Face

Avoid touching your face with unwashed hands. Germs are often spread when a person touches something that is contaminated with germs and then touches his or her eyes, nose, or mouth.

Clean Surfaces

Clean and disinfect frequently touched surfaces at home, work, or school — especially when someone is ill.

Make sure your child’s school, child care program, or college routinely cleans frequently touched objects and surfaces, and that they have a good supply of tissues, soap, paper towels, alcohol-based hand rubs, and disposable wipes on-site.

At work, routinely clean frequently touched objects and surfaces including doorknobs, keyboards, and phones to help remove germs. Learn more about effective steps for cleaning from the CDC.

Stay Home When Sick

Stay home from work, school, and errands when you are sick. This will help prevent spreading your illness to others. It’s a good idea to build an at-home kit so you have all the items you need (food, medication, etc.) to stay inside and focus on feeling better.

Practice the healthy habits above and also do your best to get plenty of sleep, be physically active, manage your stress, drink plenty of fluids, and eat nutritious food.

For the most up to date information on COVID-19 in Pennsylvania, visit the Pennsylvania Department of Health or PA Unites Against COVID and download the COVID Alert PA App.