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The Coronavirus Aid, Relief and Economic Security (CARES) Act: Provisions Relevant to Healthcare Providers

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By Michael Cook, Jennifer Papapanagiotou & Andy Lynch –  Partners at Liles Parker, PLLC.

(March 31, 2020):  On March 27, 2020, the Coronavirus Aid, Relief and Economic Security (CARES) Act[1] passed the House of Representatives by a voice vote. The President then signed the bill into law. The bill is the third round of federal government support in the wake of the coronavirus public health crisis and associated economic fallout, succeeding the $8.3 billion in public health support passed two weeks ago and the Families First Coronavirus Response Act.  Liles Parker has published a series of articles highlighting the waivers and other actions taken by the Centers for Medicare & Medicaid Services and other Federal and State agencies to ease the burden on healthcare providers during the COVID-19 public health emergency.[2]  This article is the first in a two-part series that will highlight some of the more significant provisions of the Cares Act.

I.   Support for Healthcare Providers

  • Section 3211, Supplemental Awards for Health Centers: The CARES Act provides for supplemental awards for FY 2020 for federally qualified health centers, including an additional $1,320,000,000 for the prevention, diagnosis, and treatment of COVID-19 or the detection of SARS-CoV-2.
  • Sections 3212 – 3213, Reauthorizations of HRSA Rural Development and Telehealth Network Grant Programs: The Act reauthorizes HRSA’s Rural Health Care Services Outreach, Rural Health Network Development and Small Health Care Provider Quality Improvement grant programs, as well as the Telehealth Network and Telehealth Resource Center grant programs.
  • Section 3214, Modernization of the Public Health Service: The legislation creates a Ready Reserve Corps to ensure that there are enough doctors and nurses ready to respond to public health emergencies like COVID-19.
  • Section 3215, Limitation of Liability for Volunteer Health Professionals During COVID-19 Emergency Response: This section holds harmless from liability under federal or state law, health care professionals who volunteer their service during the public health emergency for the COVID-19 pandemic declared by the Secretary of HHS.  There are a number of conditions that must be satisfied for this limitation of liability to be effective.

Among these, the limitation of liability covers only professionals who are truly volunteers and who do not receive compensation in the course of providing health care services in the diagnosis or treatment of COVID-19.  The professional must be acting within the scope of her/his license, registration, or certification under the State of licensure/certification, and may not exceed the scope of the license/certification of similar professionals in the State in which the action or omission occurs.  The limitation of liability does not cover willful or criminal misconduct, gross negligence and other similar types of flagrant misconduct.

The provision applies only to conduct that occurs on or after the date of enactment of the CARES Act and is only in effect during the period of the public health emergency declared by the Secretary during the pandemic.

  • Section 3216, Flexibility for Members of the National Health Service Corps During the Emergency Period: During the period of the emergency declaration, this provision allows the Secretary to temporarily re-assign members of the National Health Services Corps to provide service outside of the areas to which they have been assigned to respond to the COVID-19 pandemic. The assignment would need the member’s voluntary agreement and would need to be “within a reasonable distance” of the original assignment, and the member would need to maintain the number of hours originally required of her/him.    

II.   Provisions Affecting Coverage and Payment Under the Medicare & Medicaid Programs

  • Section 3701, Health Savings Accounts for Telehealth Services: This section allows a high-deductible health plan (HDHP) with a health savings account (HSA) to cover telehealth services prior to a patient reaching the deductible, increasing access for patients who may have the COVID-19 virus and protecting other patients from potential exposure.
  • Section 3702, Over-the-Counter Medical Products without Prescription: This section allows patients to use funds in HSAs and Flexible Spending Accounts for the purchase of over-the-counter drugs and menstrual care products without a prescription from a physician. This section appears to reverse the ACA and makes permanent the over-the-counter drug changes during the 2020 plan year and after.
  • Section 3703, Expanding Medicare Telehealth Flexibilities: This section eliminates the requirement included in the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 (Public Law 116-123) that limits the Medicare telehealth expansion authority during the COVID-19 emergency period to situations where the physician or other professional has treated the patient in the past three years. This enables beneficiaries to access telehealth, including in their home, from a broader range of providers, reducing COVID-19 exposure for the duration of the public health emergency.
  • Section 3704, Allowing Federally Qualified Health Centers and Rural Health Clinics to Furnish Telehealth in Medicare: This section allows, during the COVID-19 emergency period, Federally Qualified Health Centers and Rural Health Clinics to serve as a distant site for telehealth consultations. A distant site is where the practitioner is located during the time of the telehealth service. This section will allow FQHCs and RHCs to furnish telehealth services to beneficiaries in their home. Medicare will reimburse for these telehealth services based on payment rates similar to the national average payment rates for comparable telehealth services under the Medicare Physician Fee Schedule. It will also exclude the costs associated with these services from both the FQHC prospective payment system and the RHC all-inclusive rate calculation.
  • Section 3705, Expanding Medicare Telehealth for Home Dialysis Patients: This section eliminates a requirement during the COVID-19 emergency period that a nephrologist conduct some of the required periodic evaluations of a patient on home dialysis face-to-face, allowing these vulnerable beneficiaries to get more care in the safety of their home.
  • Section 3706, Allowing for the Use of Telehealth during the Hospice Care Recertification Process in Medicare: Under current law, hospice physicians and nurse practitioners cannot conduct recertification encounters using telehealth. This section allows, during the COVID-19 emergency period, qualified providers to use telehealth technologies in order to fulfill the hospice face-to-face recertification requirement.
  • Section 3707, Encouraging the Use of Telecommunications Systems for Home Health Services in Medicare: This section requires the Department of Health and Human Services (HHS) to issue clarifying guidance encouraging the use of telecommunications systems, including remote patient monitoring, to furnish home health services consistent with the beneficiary care plan during the COVID-19 emergency period.
  • Section 3708, Improving Care Planning for Medicare Home Health Services: This provision enables nurse practitioners, clinical nurse specialists, and physician assistants to order home health services, and certify and recertify patients for home health care. These changes also apply to Medicaid and become effective when HHS publishes implementing regulations, which must be within six months of the enactment of the CARES Act.  Unlike many of the provision of the Act, this provision is permanent and survives the end of the emergency.
  • Section 3709, Adjustment of Sequestration:  The CARES Act suspends the mandatory 2% global reductions under the sequestration order for the period May 1 through the remainder of calendar year 2020.
  • Section 3710, Medicare Hospital IPPS Add-On Payment for COVID-19 Patients During Emergency Period: The Act increases DRG weights by 20% for patients diagnosed with COVID-19 during the emergency period.
  • Section 3711, Increasing Access to Post-Acute Care During the Emergency Period: The Act waives certain requirements for inpatient rehabilitation facilities (IRFs) and long-term acute care hospitals (LTCHs).  For IRFs, the provision waives the requirement that a patient receive at least 15 hours of therapy per week.  For LTCHs, the provision waives the requirement of a payment adjustment where an LTCH does not have a discharge percentage of 50% of patients who would meet the eligibility requirements during the emergency period.  The provision also waives the site-neutral payment rate for discharges occurring during the emergency period that are in response to the public health emergency.
  • Section 3712, Revising Payment Rates for DME Under Medicare During the Emergency Period: This Section prohibits scheduled payment reductions in Medicare DME during 2020 and the emergency period.
  • Section 3715, Providing Home and Community-Based Services in Acute Care Hospitals:  A number of waivers under sections 1915 and 1115 of the Social Security Act provide for home and community-based services for individuals who otherwise would require care in a hospital, nursing facility, or ICF/MR.  This provision allows states to cover these services to individuals under certain of these waivers while they are in an acute care hospital if they meet certain conditions, including that they are identified in the individual’s care plan, not provided through the hospital, not a substitute for services that the hospital is otherwise required to provide, and are designed to ensure a smooth transition to the community and preserve the individual’s functional abilities.
  • Section 3719, Expansion of Medicare Hospital Accelerated Payment Program During COVID-19 Public Health Emergency: During the period of the emergency, this provision expands the accelerated hospital payment program by allowing acute care hospitals, cancer hospitals, children’s hospitals, and critical access hospitals (CAHs) to apply for up to 6-months’ advance payment of up to 100%, and for CAH’s 125%, of anticipated payments.  The provision also provides for 120 days before claims are offset to recoup these payments and not less than 12 months after the date of the first accelerated payment before the outstanding balance must be paid in full.

Administrative Implementation to Encompass All Providers:  On March 28, 2020, CMS published a press release and a Fact Sheet that expanded the availability of the accelerated advance payment program to all Medicare participating health care providers and suppliers.  These advance payments will be based on historical payments.  The Press Release states that “… [t]he payments can be requested by hospitals, doctors, durable medical equipment suppliers and other Medicare Part A and Part B providers and suppliers.”  The applicants must: have billed Medicare for claims within 180 days of the request; not be in bankruptcy; not be under active medical review or program integrity investigations; and not have delinquent Medicare overpayments.  Applications are made to the MACs, and CMS anticipates that payments will be issued within seven days of a request.  Providers described in the legislation, above, can request payments for an amount for up to a six-month period, while other types of providers can request up to a three-month period.  The Fact Sheet provides further instructions on the process.[3]

  • Section 3720, Delaying Requirements for Enhanced FMAP to Enable State Legislation Necessary for Compliance: The The Families First Coronavirus Relief Act increases State Federal assistance matching percentages (FMAP) percentages by 6.2% during the calendar quarters that encompass the emergency period if the State meets certain conditions, one of which was that it did not increase premiums in excess of what they were on January 1, or impose new premiums, during this period.  This provision gives any state that has raised or imposed such premiums since January 1, a thirty-day delay in the enforcement of that requirement – presumably to provide the State an opportunity to come into compliance without losing the increased matching rate.

III.   Health and Human Services Extenders

  • Section 3811, Extension of Money Follows the Person Rebalancing Demonstration: The CARES Act extends and provides funds for the demonstration through November 30, 2020.
  • Section 3812, Extension of Spousal Impoverishment Protections: This section of the Act extends certain protections from spousal impoverishment through November 30, 2020 to help a spouse of an individual who qualifies for nursing home care to live at home in the community.
  • Section 3813, Delay of DSH Reductions: The CARES Act delays Medicaid DSH reductions that were to begin on May 23, 2020, to begin, instead, on December 1, 2010.

IV.   Economic Stabilization and Assistance to Severely Distressed Sectors of the United States Economy

Title IV of the Act provides $500 billion in funding for loans and financial assistance to mid-size and large businesses, states and municipalities and non-profits.  $46 billion of these funds are specially allocated to the airline industry and industries critical to national security.  Assistance to airlines and national security industries will be via direct U.S. Department of Treasury loans and investments.

The remaining $454 billion is available to assist other businesses, states and municipalities and non-profits. The financial assistance will be made available via a Federal Reserve Act Section 13(3) program to provide financing through banks and other lenders.  This assistance targets businesses employing between 500 and 10,000 employees.  The assistance is contemplated primarily as low interest loans (interest rate not exceeding 2% per annum) with payments of principal and interest deferred for the first six months or longer.

The Act provides conditions on eligibility and terms and conditions of loans, including:  (i) economic conditions make the loan necessary to support ongoing operations, (ii) funds will be utilized to retain or restore at least 90% of workforce, (iii) prohibitions on dividends and stock buybacks while the loan is outstanding, and (iv) restrictions on offshoring jobs and a requirement that a majority of employees are based in the U.S. Other requirements, terms and conditions for loans and assistance will be determined and set forth in the Department of Treasury and Federal Reserve guidelines.  Title IV assistance does not provide for future loan forgiveness.

Application procedures and guidelines for the Title IV program are to be published shortly by the Department of Treasury and the Federal Reserve.

V.   HHS – Public Health and Social Services Emergency Fund

The CARES Act establishes a $100 billion “Public Health and Social Services Emergency Fund” to reimburse eligible providers for health care related expenses or lost revenues that are attributable to the coronavirus.  The Act further defines eligible health care providers to be public entities, Medicare or Medicaid enrolled suppliers and providers, and other entities that the Secretary includes that provide diagnosis, testing, or care for individuals with possible or actual cases of COVID-19.  These funds are available for building or construction of temporary structures, leasing of properties, medical supplies and equipment including personal protective equipment and testing supplies, increased workforce and trainings, emergency operation centers, retrofitting facilities, and surge capacity.  To be eligible, providers are required to apply to HHS.

VI.   Conclusion:

Liles Parker attorneys and staff are closely monitoring HHS, CMS and CDC guidance and will update as new information becomes available. Please contact us with questions or for assistance with your response to this unprecedented National Emergency.

CARES ActCARES ActCARES Act

 

 

 

 

 

Michael Cook, Jennifer Papapanagiotou and Andy Lynch are Partners at Liles Parker, PLLC.  They each have decades of experience representing health care providers and suppliers and other businesses around the country in connection with a wide range of matters.  Questions regarding the impact of recent coronavirus guidance on your organization?  Call Liles Parker for a free consultation.  We can be reached at:  1 (800) 475-1906.

[1] See this link for a full copy of the CARES Act.

[2] For a collection of all articles written by Liles Parker attorneys related to the COVID-19 public health emergency, please visit our webpage at this link.

[3] The CMS Press Release on the Accelerated and Advanced Payment process can be accessed here and the Fact Sheet can be accessed here.

Lab Testing Guidance for COVID-19

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COVID-19 Diagnostic(Updated March 31, 2020): On March 13, 2020, President Trump declared a National Emergency[1] related to the current Coronavirus / COVID-19 outbreak.  The declaration gives Secretary Alex Azar of the US Department of Health & Human Services (HHS) the power to waive certain Federal requirements in Medicare, Medicaid and CHIP in order to address the outbreak. The President’s declaration was preceded by Secretary Azar’s determination on January 31, 2020[2] that a public health emergency exists.  Since these pronouncements, Liles Parker attorneys have received numerous calls asking for clarification on these waivers and other guidance from HHS and the Centers for Medicare and Medicaid Services (CMS).  Our clients have also asked that we provide a listing of useful links and other available resources.  This article will detail the information related to lab operations and billing for COVID-19 diagnostic tests to CMS, as well as billing for COVID-19 diagnostic tests for private payors.

I.   Authorization for Use of COVID-19 Testing:

On February 6, 2020, CMS provided guidance permitting laboratories to use the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel Assay for use in CDC qualified laboratories.  At that time, testing was limited to the CDC developed test and could only be performed by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.[3] Since then, the FDA has approved a number of laboratory-developed tests being performed by private companies throughout the United States.[4]

II.   Billing for CMS:

On March 5, 2020, CMS announced new HCPCS codes for laboratories to bill Medicare for diagnostic tests for coronavirus.  There are two new HCPCS codes: U0001 and U0002.

  • U0001: This code is to be used only for the test developed by the Centers for Disease Control and Prevention (CDC) for 2019-nCoV/SARS-CoV-2.
  • U0002: This code is to be used for non-CDC developed laboratory tests for 2019-nCoV/SARS-CoV-2.

Starting April 1, 2020, Medicare claims processing systems will be able to accept these codes for dates of service on or after February 4, 2020.[5]

The following are the current COVID-19 Test Pricing as of March 12, 2020[6]:

MAC Jurisdiction (J) MAC States/Territories U0001 Test PriceU0002 Test Price
 J6 – National Government Services (NGS) Illinois, Minnesota, Wisconsin $35.91 $51.31
 JK – National Government Services (NGS)Connecticut, New York, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont $35.91 $51.31
 JH – Novitas Solutions Arkansas, Colorado, New Mexico, Oklahoma, Texas Louisiana, Mississippi $35.92 $51.33
 JL – Novitas Solutions Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania; Part B services include Arlington and Fairfax counties in VA, and the city of Alexandria, VA $35.92 $51.33
 JN – First Coast Service Options (FCSO) Florida, Puerto Rico, U.S. Virgin Islands $35.92 $51.33
 JM–Palmetto Government Benefits Administrators (PGBA)North Carolina, South Carolina, Virginia, West Virginia $35.91 $51.31
 JE – Noridian Healthcare Solutions California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands $35.91 $51.31
 JF – Noridian Healthcare SolutionsAlaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming $35.91 $51.31
 J5 – Wisconsin Physician Services (WPS) Iowa, Kansas, Missouri, Nebraska $35.92 $51.31
 J8 – Wisconsin Physician Services (WPS) Indiana, Michigan $35.92 $51.31
J15 – CGSKentucky, Ohio$35.92$51.31
JJ–Palmetto Government Benefits Administrators (PGBA) Alabama, Georgia, Tennessee $35.91 $51.31
 JM–Palmetto Government Benefits Administrators (PGBA)North Carolina, South Carolina, Virginia, West Virginia $35.91 $51.31
 JE – Noridian Healthcare Solutions California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands $35.91 $51.31
 JF – Noridian Healthcare SolutionsAlaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming $35.91 $51.31
 J5 – Wisconsin Physician Services (WPS) Iowa, Kansas, Missouri, Nebraska $35.92 $51.31
J8 – Wisconsin Physician Services (WPS) Indiana, Michigan $35.92 $51.31
J15 – CGSKentucky, Ohio$35.92$51.31

On March 31, 2020, CMS published new specimen collection codes for laboratories billing for COVID-19 testing.  To identify and reimburse specimen collection for COVID-19 testing, CMS established two Level II HCPCS codes, effective with line item date of service on or after March 1, 2020:

  • G2023 – Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source.

  • G2024 – Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), from an individual in a skilled nursing facility or by a laboratory on behalf of a home health agency, any specimen source.

These codes are billable by clinical diagnostic laboratories. (See MLN Connects, “COVID-19: Regulatory Changes, Telehealth Billing, and Specimen Collection Codes.” Published March 31, 2020).

III.   Billing for COVID-19 Diagnostic Testing to Private Payors:

Private payors are also taking measures to encourage COVID-19 diagnostic testing of their beneficiaries.  The following are the measures taken by five of the largest national payors in relation to COVID-19 diagnostic testing.[7]

  • Aetna[8]
    • Aetna will waive co-pays for all diagnostic testing related to COVID-19.
  • Anthem[9]
    • Anthem will cover the cost of coronavirus testing with no out-of-pocket cost.
    • Anthem also confirms that prior authorization is not required for diagnostic services related to COVID-19 testing.
    • Anthem’s affiliated plans will continue to waive copays, coinsurance and deductibles for diagnostic tests for COVID-19, and extending this to include waiver of copays, coinsurance, and deductibles for visits associated with in-network COVID-19 testing, whether the care is received in a doctor’s office, urgent care center or emergency department.
  • Blue Cross Blue Shield (General Association)[10]
    • BCBS announced that its network of 36 independent and locally operated companies will:
      • waive prior authorizations for diagnostic tests and covered services for COVID-19, and
      • cover those tests at no cost share to members.
    • This applies to fully insured, individual, and Medicare Advantage plan members, and plans are working with state Medicaid and CHIP agencies to ensure people have access to needed testing and services.
  • Cigna[11]
    • Cigna is covering the cost of coronavirus testing and waiving all co-pays or cost-shares for fully insured plans, including employer-provided coverage, Medicare Advantage, Medicaid, and individual market plans available through the Affordable Care Act.
    • Cigna also announced it will waive customers’ out-of-pocket costs for COVID-19 testing-related visits with in-network providers, whether at a doctor’s office, urgent care clinic, emergency room or via telehealth, through May 31, 2020.
  • UnitedHealthcare[12]
    • UHC is waiving costs for COVID-19 testing provided at approved locations in accordance with the CDC guidelines, as well as waiving copays, coinsurance and deductibles for visits associated with COVID-19 testing.
    • This coverage is not dependent on whether the care is received in a physician’s office, an urgent care center or an emergency department.
    • This coverage applies to Medicare Advantage and Medicaid members as well as commercial members.
    • UHC is also expanding provider telehealth access and waiving member cost sharing for COVID-19 testing-related visits.

IV.   Conclusion:

Liles Parker attorneys and staff are closely monitoring HHS, CMS and CDC guidance and will update this article as new information becomes available. Please contact us with questions or for assistance with your response to this unprecedented National Emergency.

COVID-19 TestingMary Soule Culter is an Associate Attorney at Liles Parker’s Washington, DC office.  She focuses her practice on regulatory health care compliance matters, fraud and abuse, and reimbursement issues. Questions regarding the Lab Testing Guidance for COVID-19?  Call Liles Parker, PLLC for a free consultation.  We can be reached at:  1 (800) 465-1906.

[1] Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, Issued on March 13, 2020, available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.

[2] Determination that a Public Health Emergency Exists, issued by Secretary Azar on January 31, 2020, available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.

[3] CMS, “Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Authorized Laboratories,” available at https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/notification-surveyors-authorization-emergency-use-cdc-2019-novel-coronavirus-2019-ncov-real-time-rt.

[4] Readers can monitor the list of FDA Emergency Use Authorizations for SARS-CoV-2 tests on the FDA’s website available at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.

[5] CMS, “Press Release: CMS Develops Additional Code for Coronavirus Lab Tests”, available at https://www.cms.gov/newsroom/press-releases/cms-develops-additional-code-coronavirus-lab-tests.

[6] CMS, “Fact Sheet: Medicare Administrative Contractor (MAC) COVID-19 Test Pricing (PDF)”, available at https://www.cms.gov/files/document/mac-covid-19-test-pricing.pdf.

[7] Visit America’s Health Insurance Plans’ (AHIP) website for more payors’ plans related to COVID-19 diagnostic testing.  See AHIP, “Health Insurance Providers Respond to Coronavirus (COVID-19)”, available at https://www.ahip.org/health-insurance-providers-respond-to-coronavirus-covid-19/?fbclid=IwAR019orl2bXznUeWbmrldExyyrdt-dZ614xaowUgoc9IHXsOg0efo-iAwoA.

[8] CVS Health, “CVS Health announces COVID-19 resources for Aetna members”, available at https://cvshealth.com/newsroom/press-releases/cvs-health-announces-covid-19-resources-aetna-members.

[9] Anthem, “Anthem Issues Updates Regarding COVID-19 Testing and Care to Support Affiliated Health Plan Members”, available at https://ir.antheminc.com/news-releases/news-release-details/anthem-issues-updates-regarding-covid-19-testing-and-care?field_nir_news_date_value[min]=.

[10] BlueCross BlueShield, “Blue Cross and Blue Shield Companies Announce Coverage of Coronavirus Testing for Members and Other Steps to Expand Access to Coronavirus Care”, available at https://www.bcbs.com/press-releases/blue-cross-and-blue-shield-companies-announce-coverage-of-coronavirus-testing.

[11] Cigna, “Cigna Covers Cost Of Coronavirus Tests For Customers”, available at https://www.cigna.com/newsroom/news-releases/2020/cigna-covers-cost-of-coronavirus-tests-for-customers.

[12] UnitedHealthcare, “UnitedHealthcare Expands Access to Care, Support and Resources to Help People and Families Address COVID-19”, available at https://newsroom.uhc.com/news-releases/UnitedHealthcare-COVID-19.html.

Coronavirus Update – HHS & CMS Guidance, Directives and Waivers with Respect to Telemedicine, Provider Enrollment Regulations, Claim Appeals, the Suspension of Non-Emergency Survey Inspections, Nursing Homes, Home Health Agencies, Dialysis Facilities and DME Suppliers.

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UPDATED (March 17, 2020): CMS just announced a waiver of certain telehealth coverage requirements so that Medicare beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. The article below has been updated to address these key takeaways.

(March 16, 2020): On March 13, 2020, President Trump declared a National Emergency[1] related to the current Coronavirus / COVID-19 outbreak. The declaration gives Secretary Alex Azar of the US Department of Health & Human Services (HHS) the power to waive certain Federal requirements in Medicare, Medicaid and CHIP in order to address the outbreak. The President’s declaration was preceded by Secretary Azar’s determination on January 31, 2020[2] that a public health emergency exists.  Since these pronouncements, Liles Parker attorneys have received numerous calls asking for clarification on these waivers and other guidance from HHS and the Centers for Medicare and Medicaid Services (CMS).  Our clients have also asked that we provide a listing of useful links and other available resources.

As a result of President Trump’s declaration of a national emergency, HHS now has broad authority to make temporary adjustments including:

  1. Applying flexibilities that are already available under normal business rules;
  2. Waiver or modification of policy or procedural norms by the Administrator of the Center for Medicare and Medicaid Services (CMS) under his or her authority; and
  3. Waiver or modification of certain Medicare requirements pursuant to waiver authority under § 1135 of the Social Security Act.

As of March 16, 2020, CMS has issued the following guidance, directives and waivers, specifically with regard to the coronavirus outbreak. We recommend providers carefully review the HHS, CMS and/or CDC guidance specific to each service, discipline or facility type for complete details.

I.   Impact of the Coronavirus on Telehealth / Telemedicine Regulations:

The Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020[3] signed by President Trump on March 6, 2020 included a specific provision addressing Medicare coverage and telehealth services. HB 6074 grants certain powers to the Secretary of Health and Human Services to waive some of the telehealth coverage requirements under the Medicare program. Unfortunately, the new law requires Secretary Azar to issue a waiver addressing any temporary changes to current Medicare telehealth coverage requirements. As of the publication of this article, a waiver has not been released, although CMS Administrator Seema Verma indicated during her remarks on March 13, 2020,[4] that more information would be forthcoming very soon. H.B. 6074 permits Secretary Azar to relax telehealth coverage requirements for all services CMS has approved to be provided via telemedicine as follows:

  • To relax the originating site requirements to include patient homes;
  • To waive the rural HPSA/non-MSA county geographic location requirement so that patients in any geographic location can receive covered telemedicine services; and,
  • To permit phone only telehealth services so long as the phone used has audio and video capabilities (i.e., most smartphones).

The law imposes certain restrictions, even under a waiver from Secretary Azar. Importantly, the relaxed coverage requirements would only extend to services provided by a physician or practitioner (or another physician or practitioner in that provider’s group practice) to an established patient, meaning an individual the provider has seen during the 3-year period before a telehealth service is furnished. We will update this article when a specific waiver is issued.

UPDATE (3/17/2020): CMS just announced a waiver of certain telehealth coverage requirements so that Medicare beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. Here are the key takeaways from this important announcement:

  • Effective for services starting March 6, 2020 and for the duration of the COVID-19 Public Health Emergency, Medicare will make payment for Medicare telehealth services furnished to patients in broader circumstances.
  • These visits are considered the same as in-person visits and are paid at the same rate as regular, in-person visits.
  • Starting March 6, 2020 and for the duration of the COVID-19 Public Health Emergency, Medicare will make payment for professional services furnished to beneficiaries in all areas of the country in all settings.
  • While they must generally travel to or be located in certain types of originating sites such as a physician’s office, skilled nursing facility or hospital for the visit, effective for services starting March 6, 2020 and for the duration of the COVID-19 Public Health Emergency, Medicare will make payment for Medicare telehealth services furnished to beneficiaries in any healthcare facility and in their home.
  • The Medicare coinsurance and deductible would generally apply to these services. However, the HHS Office of Inspector General (OIG) is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs.
  • To the extent the 1135 waiver requires an established relationship, HHS will not conduct audits to ensure that such a prior relationship existed for claims submitted during this public health emergency.
  • HHS’ Office of Civil Rights will exercise enforcement discretion and waive penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype, during the COVID-19 nationwide public health emergency.[18]

Note that the waiver does not restrict coverage to patients with coronavirus or symptoms of coronavirus. Any service that a provider can safely deliver via telemedicine and is on CMS’ list of approved telemedicine services[19] will be permitted under the new waiver. This waiver of Medicare program and HIPAA requirements will last for the duration of the COVID-19 Public Health Emergency. We do recommend that you check with your State licensing board to verify state requirements for telemedicine if you are unfamiliar with what is permitted in your state. Liles Parker has advised numerous clients with regard to telemedicine services.

In the meantime, CMS has reminded providers of the following options to provide covered non-face to face services to Medicare patients:

  • Medicare pays for “virtual check-ins” for patients to connect with their doctors without going to the doctor’s office. These brief, virtual check-in services are for patients with an established relationship with a physician or certain practitioners where the communication is not related to a medical visit within the previous 7 days and does not lead to a medical visit within the next 24 hours (or soonest appointment available). The patient must verbally consent to using virtual check-ins and the consent must be documented in the medical record prior to the patient using the service. The Medicare coinsurance and deductible would apply to these services. Doctors and certain practitioners may bill for these virtual check-in services furnished through several communication technology modalities, such as telephone (HCPCS code G2012) or captured video or image (HCPCS code G2010).
  • Medicare also pays for patients to communicate with their doctors without going to the doctor’s office using online patient portals. The individual communications, like the virtual check ins, must be initiated by the patient; however, practitioners may educate beneficiaries on the availability of this kind of service prior to patient initiation. The communications can occur over a 7-day period. The services may be billed using CPT codes 99421-99423 and HCPCS codes G2061-G206, as applicable. The Medicare coinsurance and deductible would apply to these services.
  • In addition, Medicare beneficiaries living in rural areas may use telehealth technology to have full visits with their physicians. The patient must be present at an approved telehealth originating site and must receive services using a real-time audio and video communication system at the site to communicate with a remotely located doctor or certain other types of practitioners. Medicare pays for many medical visits through this telehealth benefit. The Medicare coinsurance and deductible would apply to these services. For additional information on this benefit, please see CMS’s Telehealth resource page [5] for additional details and requirements.
  • Medicare Advantage Plans were given the authority to expand their telehealth coverage through enhanced benefit packages last year, but coverage still varies from plan to plan. CMS also issued a waiver on March 10, 2020 permitting (but not requiring) Medicare Advantage Plans to expand access to certain telehealth services. We recommend checking with the plans with which you contract for specific details or contact Liles Parker for assistance.
  • Many State Medicaid programs already cover telehealth/telemedicine services provided to patients in their homes. Liles Parker can assist in determining what your State Medicaid program covers.

II.   Impact of the Coronavirus on Medicare Provider Enrollment Regulations:

CMS has issued a blanket waiver related to provider enrollment requirements[6] to do the following:

  • Establish a toll-free hotline for non-certified Part B suppliers, physicians and nonphysician; practitioners to enroll and receive temporary Medicare billing privileges;
  • Waive the following screening requirements:
    • Application Fee – 42 C.F.R § 424.514
    • Criminal background checks associated with FCBC – 42 C.F.R § 424.518
    • Site visits – 42 C.F.R § 424.517
  • Postpone all revalidation actions;
  • Allow licensed providers to render services outside of their state of enrollment; and,
  • Expedite any pending or new applications from providers.

Liles Parker provides assistance to all types of providers seeking to enroll in the Medicare program.

III.   Impact of the Coronavirus on Medicare Claim Appeals:

CMS has issued a blanket waiver applicable to fee-for-service Medicare, Medicare Advantage and Medicare Part D claim appeals.[7]  The blanket waiver provides for the following relief:

  • Extensions to file an appeal
  • Waiving timeliness for requests for additional information to adjudicate the appeal;
  • Processing the appeal even with incomplete Appointment of Representation forms but communicating only to the beneficiary;
  • Processing requests for appeal that don’t meet the required elements using information that is available.
  • Utilizing all flexibilities available in the appeal process as if good cause requirements are satisfied.

IV.   Suspension of Non-Emergency Survey Inspections Due to Coronavirus:

On March 4, 2020, CMS issued a Memorandum[8] advising that it is temporarily suspending non-emergency survey inspections, allowing providers to focus on the most current serious health and safety threats, like infectious diseases and abuse. Specifically, survey activity is limited to the following (in Priority Order):

  • All immediate jeopardy complaints (cases that represents a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death or harm) and allegations of abuse and neglect;
  • Complaints alleging infection control concerns, including facilities with potential COVID-19 or other respiratory illnesses;
  • Statutorily required recertification surveys (Nursing Home, Home Health, Hospice, and ICF/IID facilities);
  • Any re-visits necessary to resolve current enforcement actions;
  • Initial certifications;
  • Surveys of facilities/hospitals that have a history of infection control deficiencies at the immediate jeopardy level in the last three years;
  • Surveys of facilities/hospitals/dialysis centers that have a history of infection control deficiencies at lower levels than immediate jeopardy.

CMS is maintaining a website[9] with consolidated guidance to surveyors related to coronavirus and infection control in hospitals, nursing homes, hospices, home health, and dialysis facilities.

V.   Nursing Homes:

CMS issued a revised Memorandum[10] on March 13, 2020 with specific guidance to nursing homes, including:

  • Directing nursing homes to temporarily restrict all visitors and nonessential personnel with a few exceptions such as end-of-life situations, and to cancel all communal dining and group activities.
  • Screening their staff and outside healthcare providers using CDC guidelines for restricting access to health care workers.
  • Notifying their local health department if a resident is suspected of having COVID-19. Facilities that can follow the infection prevention and control practices recommended by CDC may or may not need to transfer the patient, depending on the severity of the patient’s symptoms. If a resident must be transferred to a hospital, careful coordination with EMS and the receiving facility must be performed, including placing a facemask on the patient during transfer.
  • Accepting patients diagnosed with COVID-19 and still under Transmission-Based Precautions for COVID-19 as long as the facility can follow CDC guidance;
  • Accepting patients who are not diagnosed with COVID-19 from hospitals or other locations where a case of COVID-19 was/is present; and,
  • Obligations to maintain appropriate PPE and alcohol-based hand rub supply levels, while assuring facilities they will not be cited by surveyors so long as they can demonstrate they are having difficulty obtaining the supplies for reasons outside their control. Nursing homes are advised to contact with their local and state public health agency to notify them of any shortage, follow national guidelines for optimizing their current supply, and identify the next best option to care for their residents.

CMS also exercised its authority to waive certain coverage requirements for skilled nursing services on March 13, 2020, including the following:

  • CMS is waiving the 3-day prior hospitalization for coverage of a skilled nursing facility (SNF) stay for those people who need to be transferred as a result of the coronavirus emergency. In addition, for certain beneficiaries who recently exhausted their SNF benefits, it authorizes renewed SNF coverage without first having to start a new benefit period.
  • Second, CMS is waiving 42 CFR 483.20 to provide relief to SNFs on the timeframe requirements for Minimum Data Set assessments and transmission.

VI.   Home Health Agencies:

CMS has issued a blanket waiver[11] to provide relief to home health agencies (HHAs) on the timeframes related to OASIS Transmission. The waiver also allows Medicare Administrative Contractors to extend the auto-cancellation date of Requests for Anticipated Payment (RAPs) during emergencies. Please consult with your home health MAC for specific guidance.

Additionally, on March 10, 2020, CMS issued guidance [12] on addressing potential and confirmed COVID-19 cases and mitigating transmission including screening, treatment, and transfer to higher level care (when appropriate).

VII.   Hospitals:

On March 4, 2020, CMS issued guidance[13] regarding infection control and prevention related to COVID-19 cases.  In addition, CMS has issued blanket waivers applicable to hospitals[14] addressing a number of issues.[17] Some of the most significant include:

  • CMS is waiving the requirements that Critical Access Hospitals limit the number of beds to 25, and that the length of stay be limited to 96 hours.
  • CMS is waiving requirements to allow acute care hospitals to house acute care inpatients in excluded distinct part units, where the distinct part unit’s beds are appropriate for acute care inpatient.
  • CMS is waiving to allow acute care hospitals with excluded distinct part inpatient psychiatric units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part psychiatric unit to an acute care bed and unit.
  • CMS is waiving requirements to allow acute care hospitals with excluded distinct part inpatient Rehabilitation units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part rehabilitation unit to an acute care bed and unit.

VIII.   Coronavirus Related Waivers Issued by CMS to DME Suppliers:

A blanket waiver[15] has been issued by CMS as of March 13, 2020 to address lost, destroyed, irreparably damaged or otherwise unusable Durable Medical Equipment (DME).  DME Medicare Administrative Contractors (MACs) will have the flexibility to waive replacement requirements such that the face-to-face requirement, a new physician’s order, and new medical necessity documentation are not required. Suppliers must still include a narrative description on the claim explaining the reason why the equipment must be replaced and are reminded to maintain documentation indicating that the DMEPOS was lost, destroyed, irreparably damaged or otherwise rendered unusable or unavailable as a result of the emergency. Please check your DME MAC website for more information or contact Liles Parker for assistance.

IX.   Dialysis Facilities:

On March 10, 2020, CMS issued guidance[16] addressing potential and confirmed COVID-19 cases and mitigating transmission including screening, treatment, and transfer to higher level care (when appropriate).

X.   Conclusion:

Liles Parker attorneys and staff are closely monitoring HHS, CMS and CDC guidance and will update this article as new information becomes available. Please contact us with questions or for assistance with your response to this unprecedented National Emergency.

Jennifer Papapanagiotou is a Partner at Liles Parker, Attorneys & Clients at Law.  She has decades of experience representing health care providers and suppliers around the country in connection with a wide range of regulatory actions.  Questions regarding the impact of recent coronavirus guidance on your organization?  Call Jennifer for a free consultation.  She can be reached at:  1 (800) 465-1906.

[1] Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, Issued on March 13, 2020.  A link to the declaration can be found here.

[2] Determination that a Public Health Emergency Exists, issued by Secretary Azar on January 31, 2020.  A link to the determination can be found here.

[3] ‘‘Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020.”  H.B. 6074

[4] Emergency Declaration Press Call Remarks by CMS Administrator Seema Verma, delivered March 13, 2020.  A link to the remarks can be found here.

[1] Medicare Telemedicine Health Care Provider Fact Sheet, dated March 17, 2020, can be found here. Frequently Asked Questions expanding on the fact sheet and giving more details on implementation can be found here.

[2] HHS’s Office of Civil Rights is maintaining a website with more information on this topic here.

[3] You can find CMS’ list of approved telemedicine services here.

[5] CMS’s telehealth resource page can be found here.  

[6] COVID-19 Emergency Declaration Health Care Providers Fact Sheet, dated March 13, 2020, can be found here. Provider enrollment waivers of certain requirements are outlined in the guidance.

[7] Ibid. Waivers to the administrative claims appeals process are outlined on page 3 of the document.

[8] Memorandum titled “Suspension of Survet Activities,” dated March 4, 2020.  A copy of the Memorandum can be found here.

[9] CMS guidance titled “Updates for State Surveyors and Accrediting Organizations” can be found here.  

[10]CMS Memorandum titled Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (REVISED),” can be found here.

[11] COVID-19 Emergency Declaration Health Care Providers Fact Sheet, dated March 13, 2020, can be found here.   Home health agency guidance is on page 3 of the Fact Sheet.

[12] CMS Memorandum titled Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs), was issued on March 10, 2020, and can be found here.

[13] CMS Memorandum titled Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge,” dated March 4, 2020, can be found here.  

[14] COVID-19 Emergency Declaration Health Care Providers Fact Sheet, dated March 13, 2020, can be found here.   Hospital guidance is on pages 1-3 of the Fact Sheet.

[15]COVID-19 Emergency Declaration Health Care Providers Fact Sheet, dated March 13, 2020, can be found here.   DME related guidance is on page 1 of the Fact Sheet.

[16] CMS issued guidance on March 10, 2020

[17]  Medicare Telemedicine Health Care Provider Fact Sheet, dated March 17, 2020, can be found here. Frequently Asked Questions expanding on the fact sheet and giving more details on implementation can be found here. 

[18] HHS’s Office of Civil Rights is maintaining a website with more information on this topic here.

[19] You can find CMS’ list of approved telemedicine services here.

[20]