CMS says the Administration is relaxing regulations to aid COVID-19 care and protect healthcare workers.

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Apr. 3, 2020

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FEATURED STORY
 

CMS Relaxing Regulations to Facilitate COVID-19 Care and Protect Healthcare Workers

 
 

While Americans nationwide continue to shelter in place in response to COVID-19 in an effort to flatten the curve, the federal government and the Centers for Medicare & Medicaid Services (CMS) are taking steps to expand healthcare services to those affected by continuing to cut the red tape.

On Monday, CMS released an interim final rule with comment period to “help the healthcare system deal with patient surges by giving it tools and support to create non-traditional care sites and staff them quickly.” Employing a patient-centric approach, CMS granted an unprecedented number of waivers to lesson administrative burdens while granting tools, support, and staff to non-traditional care sites to help build capacity for the expected increase of patients. The changes are effective during the public health emergency.

The CMS temporary relaxation in regulations is designed to:

  • Increase Hospital Capacity—CMS Hospitals Without Walls
    • The idea here is to leverage local resources. For example, ambulatory surgery centers that are following guidelines to cancel elective surgeries can contract with local healthcare systems to provide hospital services. CMS is also expanding the ability to test for COVID-19 outside of the laboratory or hospital setting to community settings such as home, drive-thru testing, and other off-campus sites deemed a safe environment to test patients while alleviating strain on hospital staff and resources.
    • Physician-owned hospitals may increase the number of their licensed beds, operating rooms, and procedure rooms to accommodate the needs of the community.
    • Hospitals are allowed, and encouraged, to bill for services provided outside their walls. Telehealth services can aid in quickly assessing patients’ needs while freeing up emergency resources.
  • Rapidly Expand the Healthcare Workforce, Put Patients Over Paperwork, and Further Promote Telehealth in Medicine
    • Requirements have been waived for certified registered nurse anesthetists to operate at the fullest extent of their license with limited physician supervision, thus freeing up physicians. While non-essential surgical procedures are postponed, barriers have been removed to add those staff to hospital rosters.
    • CMS is eliminating paperwork to allow clinicians to spend more time with patients. Additionally, Medicare will now cover respiratory-related devices for any medical necessity, not just in certain circumstances, while suspending deadlines, documentation requests, audits, and reporting requirements.
    • CMS continues to build on telehealth services by expanding reimbursement and allowing for an additional 80 services to be furnished by telehealth. Providers can bill telehealth services at the same rate as office visits, thus enabling patients to seek care from the safety of their home.

We encourage you to review the associated fact sheet describing the changes CMS is implementing to ensure the health and safety of Americans.

 

No Shirt, No Shoes, No Problem. But Do You Have to Wear Pants for Doctor Appointments?

 
 

Considering today’s stay-at-home environment, some hospitals, physicians, and other healthcare professionals (HCPs) may be asking if they will be reimbursed for visits performed virtually. In recent days, coders and billers have been bombarded with information from the Trump Administration, CMS, the American Medical Association (AMA), the Centers for Disease Control and Prevention (CDC), and the International Classification of Diseases (ICD) Coordination and Maintenance Committee regarding new policies, guidelines, and codes created to report diagnosis and telehealth services related to the COVID-19 pandemic.

Much of the new guidance may also help HCPs obtain reimbursement for telehealth services for other conditions. For example, Medicare’s relaxed rules around covered telehealth services may allow certain HCPs to perform a “visit” with a patient at home using certain types of technology previously not allowed.

Xcenda’s consolidated coverage, coding, and payment research may help HCPs with their top reimbursement questions. Let Xcenda keep you informed on how HCPs can report virtual services performed via various forms of telecommunication. Start a conversation >

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LEGISLATIVE UPDATE
 

Discussions are underway in Congress about a phase 4 COVID-19 relief package. In the meantime, however, Congress is on recess until April 20—and potentially beyond based on CDC guidance.

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COVID-19 RESOURCES AND BULLETIN
 

Yes, news, policies, guidances, and other materials about the novel coronavirus outbreak have swept aside much of the traditional policy activities. Therefore, we’re including a separate section to aggregate COVID-19 materials so it doesn’t do the same to our newsletter.

 

COVID-19 Resources

 
 

Coronavirus Task Force Resources and Updates

CDC Information for Healthcare Professionals

CMS Current Emergencies (Coronavirus)

Medicaid and Children’s Health Insurance Program (CHIP) Resources

American Medical Association (AMA) Physician’s Guide to COVID-19

 

COVID-19 Bulletin

 
 

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PUTTING XCENDA EXPERTISE TO WORK
 

Where the Rubber Meets the Road: Impact of Pandemic on Patient Support Programs

 
 

As the COVID-19 pandemic continues to touch nearly every aspect of our way of life, the impending economic challenges portend a significant impact on patient access to critical and life-saving therapies. As social distancing and shelter-in-place orders threaten to generate extraordinary unemployment figures, newly laid-off workers may lose employer-sponsored health insurance or lack the resources to afford a health plan on the individual market. Down the road, the economic downturn may also drain state budgets, forcing state governments to make difficult decisions regarding Medicaid benefits and eligibility. And, even those individuals and families maintaining health insurance coverage through commercial plans or even Medicare may be forced to make difficult decisions regarding prescribed therapies, potentially necessitating a greater need for copay or foundation assistance.

Given this unprecedented pandemic and its potential impact on patients across different therapeutic areas, patient support programs must be prepared to help their patient populations. Free goods or patient assistance programs (PAPs)—including bridge programs or temporary PAPs—are likely to bear the brunt of the incoming wave of demand for financial assistance. It will be critical for PAPs and even commercial copay assistance programs to gauge this demand and have the resources on hand to philanthropically support patients.

To better understand the impact, access the issue brief and infographic:

In these uncertain times, it’s important to prepare for every possible scenario. Xcenda’s patient support experts stand ready to equip you and your program for the challenges in the days, weeks, and months ahead. Please contact Corey Ford to discuss further. Stay safe!

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REGULATORY UPDATES
 

HHS/FDA Authorizes Emergency Use of Drugs, Biologics, and Tests

 
 

Earlier this week, HHS officially released an Emergency Use Authorization (EUA) Declaration that allows the Commissioner of the Food and Drug Administration (FDA) to issue EUAs for the emergency use of drugs and biologicals to treat certain hospitalized patients with COVID-19.

The HHS Secretary can declare an EUA justified if it meets 1 of 4 requirements. For this specific authorization, the HHS Secretary determined there is a public health emergency that can significantly affect national security or the health of US citizens and involves a chemical, biological, radiological, or nuclear (CBRN) agent(s) or disease or condition caused by a CBRN agent(s).

Currently, only hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile are authorized through the EUA to be used as prescribed treatment for certain hospitalized COVID-19 patients when it cannot be accessed through a clinical trial. However, studies are being done that may lead to additional drugs being considered for an EUA. Gilead’s remdesivir is currently in phase 3 clinical trials to test the safety and efficacy in adult patients with COVID-19. In addition, a small, open-label, non-randomized study in France found that hydroxychloroquine in combination with azithromycin was associated with reducing viral load in patients with COVID-19.

Relatedly, yesterday, the FDA granted its first EUA for a coronavirus test to the manufacturer Cellex. Its product, the impossibly named qSARS-CoV-2 IgG/IgM RapidTest, analyzes antibodies in the blood to determine if someone has been exposed to the virus.

As more COVID-19 infections get diagnosed, these HHS and FDA actions are welcomed in hopes of successfully treating patients with COVID-19. However, there are some concerns about the available supply, as the FDA listed hydroxychloroquine sulfate and chloroquine phosphate products as “Currently in Shortage” this week.

 

Information Buffet (AKA, Other Stuff That Caught Our Attention)

 
 

We kept running into stories we wanted to bring to your attention, so here’s a quick hit list of other news we thought you should know:



 

Determine Your Value Story With Greater Precision and Perspectives With Xcenda’s Value Identification Process 2.0

 
 

Gathering diverse perspectives to pinpoint and vet your product’s value messages is, well, invaluable. But assembling HEOR, brand, patient support, legal, and field personnel in 1 room for a workshop can be daunting, especially in this current safer-at-home or shelter-in-place environment.
 
With Xcenda’s Value Identification Process (VIP) 2.0, critical viewpoints of all your key stakeholders can now be captured through our interactive, real-time format that makes identifying and ranking your most salient go-to-market messages easier than ever before. Learn more >

 
HEARD ON THE STREET

“We are working hard to offer billions of dollars of additional resources and enhanced coverage. But these resources are not infinite.”

 – Kristine Grow, America’s Health Insurance Plans (AHIP) Senior Vice President of Communications, responding to the American Hospital Association (AHA)’s wish that “private insurers to expedite processing of ‘billions of dollars’ in outstanding claims scale back administrative processes that can be a time sink for providers and delay payment, including prior authorization, and make sure they provide ‘adequate’ coverage for COVID-19, including covering all cost-sharing for treatment.”

Source: “AHA Wants Private Payers to Do More to Help Hospitals Fight COVID-19. Payers Say They’ve Done a Lot Already,” Healthcare Dive, April 2

 
POLICY BY NUMBERS
 

$25,000

 

The AHA is asking HHS and CMS to immediately distribute funds to every hospital in the US at a rate of $25,000 per bed and $30,000 per bed for COVID-19 “hot spots.” Funds would come from the Coronavirus Aid, Relief, and Economic Security (CARES) Act designated for providers.

Source: “AHA Urges HHS and CMS to Distribute Funds to Hospitals and Health Systems as Designated by CARES Act,” AHA, March 31

 
 

Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.

 
 
 
 
 
FEATURED CONTRIBUTORS
 

EDITOR-IN-CHIEF:
Jennifer Snow
Vice President,
Reimbursement and
Policy Insights,
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Doug Cook
President | Commercialization Services & Animal Health

Kristine Flemister, PharmD
President | Xcenda

Tommy Bramley, PhD, RPh
President | Lash Group

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

Rita Norton
Senior Vice President | Government and Public Policy | AmerisourceBergen Corporation

Ana Stojanovska
Vice President | Commercial Consulting | Xcenda

CONTRIBUTING AUTHORS:

Jason Eaton | Corey Ford | Jennifer Le | Scott Shields

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Apr. 3, 2020

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