This page was last updated on 06/25/2020.  Please check back frequently for updates.

ASCO has compiled resources from federal agencies and state health departments for oncology professionals to access rapidly changing information on the COVID-19 pandemic. These links capture updates from government authorities and payers and will be updated on a regular basis as new resources become available. Additionally, ASCO has developed resources to address existing information gaps.

ASCO Resources

Financial Assistance for Providers During COVID-19

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) into law. The law, which established new stimulus and aid programs, will provide more than $2 trillion in emergency economic relief to individuals and businesses affected by the coronavirus crisis through numerous federal agencies. ASCO is providing this resource guide to assist members in accessing critical support needed to sustain the care of patients with cancer. 

This information is subject to change as federal agencies continue to update and provide clarifying guidance on these programs, and as new legislation is enacted by Congress and the White House. Decisions about which option(s) to pursue will depend on your individual practice situation. ASCO recommends that you consult with your financial advisor about the options outlined in the guide.

CMS Resources, Highlights, and Updates

On January 31, 2020, Health and Human Services (HHS) Secretary Azar declared a public health emergency effective January 27, 2020, affording the Centers for Medicare & Medicaid Services (CMS) the flexibility to quickly support Medicare beneficiaries. On March 13, 2020, the President declared a national emergency effective March 1, 2020, affording additional flexibilities such as Section 1135 waivers.

Four coronavirus-related relief bills were passed in quick succession in March and April of 2020 with many provisions aimed at assisting providers and hospitals with additional flexibilities and financial relief. On June 23, 2020, CMS issued FAQs on the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, and other health coverage issues related to COVID-19 (Part 43). The FAQs were prepared jointly by the Department of Labor (DOL), the Department of Health and Human Services (HHS), and the Department of the Treasury.

Previously issued FAQs are available here and here.

Following is a summary of important CMS actions and announcements related to patient care and coverage at this time.

Preliminary Medicare COVID-19 Data Snapshot

On June 23, 2020, CMS released a Preliminary Medicare COVID-19 Data Snapshot. The data shows that older Americans and those with chronic health conditions are at the highest risk for COVID-19 and confirms disparities in health outcomes for racial and ethnic minority groups and among low-income populations.

New Flexibilities for the Oncology Care Model, Other Innovation Center Models

On June 3, 2020, CMS announced new flexibilities for a number of its Innovation Center models, including the Oncology Care Model (OCM). For the OCM, options include forgoing or adjustment of financial risk, changes to quality reporting, and an extension of the model timeline for one year through June 2022.

For more information and details on changes to affected Innovation Models, including the OCM, see this new resource from CMS.

CMS Letter to Clinicians

CMS issued a letter to all Medicare physicians summarizing the policy changes made over the last several weeks to increase flexibility and allow health care providers to increase time spent caring for patients. In this letter, CMS discusses accelerated and advanced payments, telehealth and virtual visits, testing and coverage of COVID-19 related services, workforce flexibilities, MIPS data submission, and technical and clinical guidance resources.

CARES Provider Relief Fund: Disbursements, Payment Portal and Required Attestations

The deadline for health care providers to attest to receipt of payments from the Provider Relief Fund and accept the Terms and Conditions was extended for a second time on May 22 to a total of 90 days, increased from the original 30 days. The text below has been updated to reflect this extension.

First General Allocation Disbursement ($30B)

On April 16, CMS opened its “CARES Provider Relief Fund” payment portal. Recipients of the payments from the first $30 billion disbursement (based on Medicare FFS billing and deposited automatically into accounts associated with TINs) must sign an attestation through this portal confirming receipt of the funds and agree to the terms and conditions (T&Cs) within 90 days of payment. Recipients who choose to reject the funds must also complete the attestation to indicate fund rejection; not returning the funds within 90 days will be viewed as acceptance of the terms and conditions.

Providers are encouraged to carefully review the T&Cs in full prior to attestation. Requirements include, but are not limited to, the following:

  • Payment will only be used to prevent, prepare for, and respond to coronavirus, and shall reimburse the recipient only for health care related expenses or lost revenues that are attributable to coronavirus
  • For all care for a possible or actual case of COVID-19, recipient certifies that it will not seek to collect from the patient out-of-pocket expenses in an amount greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network recipient
  • Not later than 10 days after the end of each calendar quarter, any recipient that is an entity receiving more than $150,000 total in funds under the CARES Act and related Acts shall submit to the Secretary and the Pandemic Response Accountability Committee a detailed report of how funds were expended or obligated
  • The recipient must maintain appropriate records and cost documentation and other information required by future program instructions to substantiate the reimbursement of costs under this award, and shall submit reports as the Secretary determines are needed

HHS partnered with UnitedHealth Group (UHG) to deliver the stimulus payments, and physicians should contact UHG’s Provider Relations at 866-569-3522 about eligibility, whether a payment has been issued, and where it was sent. If a physician or practice did not already set up direct deposit through CMS or UHG’s Optum Pay, they will receive a check at a later date. Practices that would like to set up direct deposit now can call the UHG Provider Relations number. 

Second General Allocation Disbursement ($20B)

On April 22, HHS announced that an additional $20 billion will be available for Medicare providers and facilities as part of the “General Allocation” fund. Funds will be based on 2018 net patient revenue, not just Medicare Fee for Service. On April 24, a portion of providers were automatically sent an advance payment based on the revenue data they submitted in CMS cost reports. Providers without adequate cost report data on file will need to submit their revenue information to the new portal for distribution of these funds. Providers who receive funds automatically will still need to submit revenue information for verification. Like the distribution of the initial $30 billion, providers must confirm receipt of funds and agree to the terms and conditions within 90 days.

For a more detailed description of the second general allocation disbursement ($20B) and of the full $40.4B distributed in this second round ($20B in general allocation, $20.4B in targeted allocation), please see ASCO’s HHS Provider Relief Fund Guide and HHS’ CARES Act Provider Relief Fund General Distribution FAQs.

Allocation to Medicaid and CHIP Providers, Safety Net Hospitals and “Hotspots” ($25B)

On June 9, 2020, HHS (through HRSA), announced additional distributions to eligible Medicaid and Children's Health Insurance Program (CHIP) providers that participate in state Medicaid and CHIP programs.

Medicaid and CHIP Providers ($15B). On June 10, 2020, HHS launched an enhanced Provider Relief Fund Payment Portal that will allow eligible Medicaid and CHIP providers to report their annual patient revenue, which will be used as a factor in determining their Provider Relief Fund payment. The payment to each provider will be at least 2% of reported gross revenue from patient care; the final amount each provider receives will be determined after the data is submitted, including information about the number of Medicaid patients that providers serve.

To be eligible for this funding, health care providers must not have received payments from the $50 billion Provider Relief Fund General Distribution and must have directly billed their state Medicaid/CHIP programs or Medicaid managed care plans for health care-related services between January 1, 2018, and May 31, 2020. HHS is requiring significantly more information from Medicaid providers than from Medicare providers who received money through the General Distribution, including calculating lost revenues due to COVID-19, payer mix information, and any other funding received through the Paycheck Protection Program.

The enhanced payment portal and detailed information, including terms and condition, is available here. More general information about eligibility and the application process is also available on HHS’ website.

Safety Net Hospitals ($10B). HHS also announced the distribution of $10 billion in Provider Relief Funds to safety net hospitals. This payment is being sent directly to these hospitals via direct deposit the week of the announcement and is going to hospitals that serve a disproportionate number of Medicaid patients or provide large amounts of uncompensated care. Recipients will receive a minimum distribution of $5 million and a maximum distribution of $50 million. Qualifying hospitals will have:

  • Medicare Disproportionate Payment Percentage (DPP) of 20.2% or greater;
  • Average Uncompensated Care per bed of $25,000 or more per year;
  • Profitability of 3% or less, as reported to CMS in its most recently filed Cost Report.

Additional “Hotspot” Funding for Hospitals. On June 8, 2020, HHS sent communications to all hospitals asking them to update information on their COVID-19 positive-inpatient admissions for the period January 1, 2020, through June 10, 2020. This information will be used to determine a second round of funding to hospitals in COVID-19 hotspots. To be considered for funding from this $10 billion distribution, hospitals must submit their information by June 15, 2020, at 9:00 p.m. ET.

CARES Act Provider Relief Fund FAQs from HHS are available here and here. HHS has also published a state-by-state listing of targeted payments to safety net hospitals through the Provider Relief Fund.

Telehealth

Effective for services starting March 1, 2020 and for the duration of the COVID-19 Public Health Emergency, Medicare will make payment for telehealth services for all Medicare beneficiaries. ASCO has developed a reference guide for telehealth services and other communication-based technology services including e-visits, virtual visits, and telephone evaluation and management services in Medicare. Additionally, we have created a new guide regarding telehealth coverage and Medicaid.

Quality Payment Program Hardship Exemption Guide

Data Submission for Performance Year 2019

In response to the COVID-19 pandemic, CMS extended the deadline to submit MIPS data for the 2019 performance year to April 30, 2020.  Eligible clinicians who do not submit data by this deadline may qualify for the 2019 automatic Extreme and Uncontrollable Circumstances policy and receive a neutral payment adjustment in 2021. CMS has also re-opened the 2019 Extreme and Uncontrollable Circumstances application to individuals, groups and virtual groups, including those who have already submitted data.

The resource at the link above summarizes a variety of scenarios clinicians may find themselves in and indicates whether a clinician is: (1) covered by the automatic policy, or (2) would need to submit an application to request that all four performance categories be reweighted to 0%.

Additional details are available in this CMS fact sheet (last updated 6/11/2020).

Data Submission for Performance Year 2020

On June 24, 2020, CMS released a fact sheet on flexibilities for clinicians participating in MIPS in 2020. Specifically, clinicians significantly impacted by the public health emergency may submit an Extreme & Uncontrollable Circumstances Application to reweight any or all of the MIPS performance categories or may apply for the MIPS Promoting Interoperability Performance Category Hardship Exception. Those requesting relief via the application(s) will need to provide a justification of how their practice has been significantly impacted by the public health emergency. In addition to the fact sheet, see the QPP Exception Applications webpage for more information about eligibility and submission.

CMS Flexibilities for Physicians

CMS has issued an array of regulatory revisions and waivers in response to COVID-19 in an effort to reduce patient and provider exposure and increase the capacity of the health care system to see as many patients as possible.

  • Relaxed supervision rules to allow for direct supervision to occur through real-time audio/visual interaction.
  • CMS has waived rules stating that Medicare patients in the hospital must be under the care of a physician, which allows PA, NPs to practice to the fullest extent possible.
  • CMS will allow Chief Medical Officers (or equivalent in the absence of a CMO) discretion to determine if physician supervision requirements stated in the NCD/LCD are necessary and the discretion to authorize a different physician specialty to provide the service.
  • CMS will allow physicians to contract with qualified infusion suppliers to perform home infusion under audio/visual supervision of a physician when needed.

CMS Reevaluates Accelerated Payment Program and Suspends Advanced Payment Program

On April 26, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. Beginning on April 26, 2020, CMS will not be accepting any new applications for the Advance Payment Program, and CMS will be reevaluating all pending and new applications for Accelerated Payments. 

Funding will continue to be available to hospitals and other health care providers on the front lines of the coronavirus response primarily from the Provider Relief Fund.

The guide ASCO earlier created for members to quickly direct them to the forms and resources needed for the Advanced and Accelerated Payment Programs remains available here.

Delay of Non-Essential Surgeries and Procedures

CMS released guidance to limit elective and non-essential surgeries and procedures to reduce exposure and to conserve PPE resources. The guidance outline factors that should be considered for postponing elective surgeries, and non-essential medical, surgical, and dental procedures. Those factors include patient risk factors, availability of beds, staff and PPE, and the urgency of the procedure. 

On April 19, 2020, CMS issued recommendations to provide non-essential health care services in areas with low-incidence of COVID-19. The new recommendations are specifically targeted to communities with low incidence or relatively low and stable incidence of COVID-19 cases. The decision to begin performing non-essential services must be decided at a local level, and to begin Phase 1, the following criteria must be met:

  • Symptoms: downward trajectory of influenza-like illnesses and COVID-19-like illnesses reported within a 14-day period
  • Cases: downward trajectory of documented COVID-19 cases or proportion of positive COVID-19 tests over a 14-day period
  • Hospitals: must be able to treat all patients without crisis care and have a robust testing program in place for at-risk health care workers, including emerging antibody testing

CMS has issued guidance for providers that may begin Phase 1. Providers that meet the gating criteria may begin performing non-essential services and procedures on an outpatient basis. Considerations need to be made regarding workforce availability, PPE and supplies, testing capacity, and sanitation protocols.

CMS released guidance for health care facilities in areas currently in Phase II of reopening. This includes states and regions with no evidence of a rebound that satisfy the Gating Criteria a second time. Health care systems and clinicians must preserve the capacity to care for potential surges of COVID-19 patients and ongoing fluctuations of COVID-19 needs; however, they have the flexibility to resume non-emergent non-COVID related care. Providers must continue to consider and ensure adequate workforce, testing, facilities, PPE and supplies when entering Phase II.

CMS states that facilities and providers in areas still seeing a higher number of COVID-19 cases are encouraged to continue following the recommendations made by CMS to delay non-essential services. All patients and providers are encouraged to continue the use of telehealth when available and appropriate.

Provider Location

Section 1135 of the Social Security Act will temporarily waive requirements that out-of-state providers be licensed in the state where they are providing services when they are licensed in another state; however, this does NOT override state laws on licensure. For this waiver to apply, the state must also waive these requirements. This waiver applies to Medicare and Medicaid.

Workforce Flexibilities

CMS and the Assistant Secretary of Preparedness and Response (ASPR) released a new toolkit to help state and local health care decision makers maximize workforce flexibilities when confronting COVID-19 in their communities. The toolkit includes resources such as information on funding flexibilities, liability protections, and workforce training.

Billing, Coding, and Coverage of COVID-19

ASCO has developed a quick reference guide on billing and coding for coronavirus testing and diagnosis.

Requests for Early Prescription Refills

MACs will consider on a case by case basis whether to pay for greater than a 30-day supply of a Part B drug. Variables included in consideration are the nature of the drug, the patient’s diagnosis, the extent and likely duration of disruptions to the drug supply chain during an emergency, and other relevant factors to determine if the advanced refill is reasonable and necessary.

Part D Sponsors may waive prescription refill limits allowing an affected enrollee to obtain the maximum extended day supply available under their plan, if requested and available. They may also relax restrictions on home or mail delivery of prescription drugs.

Prior Authorization

Medicare Advantage:

Medicare Advantage Organizations may waive prior authorization requirements for tests or services related to COVID-19.

Part D:

Part D Sponsors may waive prior authorization requirements for Part D drugs used to treat or prevent COVID-19, if or when such drugs are identified.

Vaccines

When a vaccine for COVID-19 is available, all Part D plans will be required to cover the vaccine.

Quality, Safety, and Oversight

CMS has released several Quality, Safety, and Oversight memoranda to State Survey Agency Directors with guidance and mechanisms for CMS and state agency inspectors to focus their efforts, personnel and related resources on addressing COVID-19 spread and containment.

  • Suspension of Survey Activities: Identifies modifications to the survey and certification processes asking health care providers to focus on infection control and prevention of COVID-19.
  • Hospitals: Outlines guidance for hospital administrators regarding screening visitors and patients and monitoring and restricting health care facility staff from working in case of exposure.
  • Outpatient Settings: This guidance for outpatient settings (including ambulatory surgical centers, comprehensive outpatient rehabilitation facilities, community mental health centers, rural health centers, federally qualified health Centers) discusses recommendations to mitigate transmission including screening, restricting visitors, cleaning and disinfection, possible closures, and supply scarcity guidance.
  • Nursing Homes: Provides guidance to help nursing homes limit the transmission of COVID-19, including guidance for monitoring or restricting staff, managing transfers and admissions of patients with suspected or confirmed COVID-19 infection, and guidance for visitors. Updates require nursing homes to inform residents, their families and representatives of COVID-19 cases in their facilities. On May 13, CMS issued a toolkit on state actions to mitigate COVID-19 prevalence in nursing homes.
  • Hospice: Supports hospices with information about how to address potential and confirmed COVID-19 cases, including the screening, treatment, and transfer of patients to higher level of care, when appropriate.
  • Emergency Departments: Provides guidance to hospitals with emergency departments on patient screening, treatment and transfer requirements to prevent the spread of infectious disease and illness, including COVID-19. CMS requires facilities to maintain infection control and prevention policies as a condition for participation in the programs.
  • Home Health and Religious Nonmedical Health Care Institutions: Covers how HHAs should screen patients for COVID-19, guidance on monitoring and restricting home health visits for health care staff, and a FAQ section for home health workers.

Additional HHS/CMS Resources

Private Payers and Telehealth

Private insurers and other payers have been changing and expanding their coverage policies for telehealth in response to COVID-19. ASCO has developed a resource guide to help cancer care providers and patients follow this change.  This chart will be regularly updated, but we also encourage individuals to independently confirm the coverage details for their respective plans.

Drug Enforcement Agency (DEA) and FDA Guidance

Satellite Hospital/Clinic Locations, Receipt and Use of Controlled Substances. DEA has issued two exceptions to regulations for DEA-registered hospital/clinics: 1. the ability to utilize alternate satellite hospital/clinic locations under their current DEA registrations without the need to apply for a separate DEA registration for the alternate site; and 2. distributors can ship controlled substances directly to these alternate satellite hospital/clinic locations that do not have their own DEA registrations (i.e. non-registered). These two exceptions are in effect from April 10, 2020, until the public health emergency declared by the Secretary of Health and Human Services (HHS) ends or the DEA specifies an earlier date. 

Exception to the “Five Percent” Rule. Under existing DEA regulations, a practitioner who is registered to dispense may distribute limited amounts of controlled substances to another practitioner for the purpose of general dispensing by the other practitioner to patients, if certain conditions are met. Among these conditions is that the amount a practitioner so distributes to other practitioners during a calendar year cannot exceed five percent of the total number of dosage units of all controlled substances that the practitioner dispenses and distributes during that year. The DEA has also provided an exception to this “five percent” rule, allowing for the distribution of controlled substances of more than the five percent that a practitioner can distribute to another practitioner during the calendar year. This exception is in effect from January 1, 2020, until the public health emergency ends or the DEA specifies an earlier date or otherwise first modifies or withdraws this exception. the date this exception ends.

The full guidance for these exceptions is available here.

The FDA has issued a temporary policy (last updated 5/21) covering the compounding of certain drugs for hospitalized patients by outsourcing facilities during the COVID-19 public health emergency. The FDA has also issued a temporary policy (last updated 5/21) covering the compounding of certain drugs by pharmacy compounders not registered as outsourcing facilities. This policy allows for the compounding of a drug that is essentially a copy of a commercially available drug, or for providing a drug to a hospital without obtaining a patient-specific prescription, if specific circumstances are present and certain conditions are met. This policy will end with the termination of the public health emergency or at an earlier date specified by FDA.

The FDA has also issued a temporary policy on the repackaging and combination of propofol drug products; propofol is on the FDA drug shortage list and is a critical drug for the treatment of patients extremely ill with COVID-19.

Implementation Dates for Many Interoperability Provisions Delayed

On March 9, 2020, the Office of the National Coordinator for Health Information Technology (ONC) and CMS released companion final rules on interoperability and information blocking. ONC and CMS have now delayed the original implementation dates for many of the provisions detailed in the rules. For further information see the ONC announcement and CMS announcement.

NIH Resources

CDC Resources

FDA Resources

Additional Federal Agency Information

Other Resources