This page was last updated on 10/15/2020.  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. On July 23, 2020, the Secretary renewed the public health emergency, effective July 25; the renewal expires after 90 days (on October 23) unless renewed again by the Secretary

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.

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 (PRF): Disbursements, Payment Portal, and Required Attestations & Reporting

Applications for Phase 3 General Distribution funding will be accepted from October 5, 2020 through November 6, 2020.

On October 1, 2020, HHS announced $20 billion in new funding for providers and opened the application portal on October 5. Additional HHS resources include a fact sheet, step-by-step application guide, and a stakeholder toolkit.

Under this Phase 3 General Distribution allocation, providers that have already received Provider Relief Fund payments will be invited to apply for additional funding that considers financial losses and changes in operating expenses caused by the coronavirus. Previously ineligible providers, such as those who began practicing in 2020, will also be invited to apply, and an expanded group of behavioral health providers will also be eligible for relief payments.

For eligible providers, the new Phase 3 General Distribution is designed to balance an equitable payment of 2 percent of annual revenue from patient care for all applicants plus an add-on payment to account for revenue losses and expenses attributable to COVID-19.

Eligible providers include:

  • Providers who previously received, rejected, or accepted a General Distribution Provider Relief Fund payment. Providers that have already received payments of approximately 2% of annual revenue from patient care may submit more information to become eligible for an additional payment.
  • Behavioral Health providers, including those that previously received funding and new providers.
  • Healthcare providers that began practicing January 1, 2020 through March 31, 2020. This includes Medicare, Medicaid, CHIP, dentists, assisted living facilities, and behavioral health providers.

All eligible providers will be considered for payment against the below criteria:

  • All provider submissions will be reviewed to confirm they have received a Provider Relief Fund payment equal to approximately 2 percent of patient care revenue from prior general distributions. Applicants that have not yet received Relief Fund payments of 2 percent of patient revenue will receive a payment that, when combined with prior payments (if any), equals 2 percent of patient care revenue.
  • With the remaining balance of the $20 billion budget, HRSA will then calculate an equitable add-on payment that considers the following:
    • A provider’s change in operating revenues from patient care,
    • A provider’s change in operating expenses from patient care, including expenses incurred related to coronavirus, and
    • Payments already received through prior Provider Relief Fund distributions.

HHS states that this distribution requires cooperation on the part of all applicants and is urging all eligible providers to apply early; do not wait until the last day or week of the application period. Applying early will help to expedite HHS’s review process and payment calculations, and ultimately accelerate the distribution of all payments. All payment recipients will be required to attest to receiving the Phase 3 General Distribution payment and accept the associated Terms and Conditions. Providers should closely review the Terms and Conditions and associated reporting requirements to ensure they are aware of their obligations if they apply for these funds.

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 and a listing of PRF distributions to providers that have accepted the Terms and Conditions.

On September 19, 2020, HHS posted a notice informing Provider Relief Fund (PRF) recipients who received one or more payments exceeding $10,000 in the aggregate of the data elements that they will be required to report as part of the post-payment reporting process. This is a supporting document to the July 20, 2020 Post-Payment Notice of Reporting Requirements (last updated August 14, 2020). A summary of reporting requirements is available here.

Key dates include:

  • Jan. 15, 2021: reporting portal opens for providers
  • Feb. 15, 2021: first reporting deadline for all providers on use of PRF funds
  • July 31, 2021: final reporting deadline for providers who did not fully expend PRF funds prior to December 31, 2020

This notice informs recipients of the categories of data elements that recipients must submit for calendar years 2019 and 2020 as part of the reporting process. HRSA plans to offer Question & Answer Sessions via webinar in advance of the reporting deadline, and as needed, HRSA will also issue Frequently Asked Questions to aid in the reporting process.

Included in the required data is demographic information, expenses attributable to coronavirus not reimbursed by other sources (general and administrative expenses, healthcare related expenses), lost revenues attributable to coronavirus, and other assistance received. Additional non-financial data will also be collected per quarter, such as personnel metrics, patient metrics, and facility metrics. HHS is also requiring the reporting of total calendar year expenses for 2019 and 2020, with quarterly breakdowns, for general and administrative expenses and healthcare related expenses.

These newly issued reporting requirements are comprehensive and detailed and it is important that providers review them in full to understand their reporting obligations and meet the deadlines set by HHS for reporting. For additional information see the HHS webpage on Reporting Requirements and Auditing and these associated FAQs.

August 26, 2020: Additional FAQs on the Treatment of Coronavirus Disease Relief Payments on the Medicare Cost Report. On August 26, 2020, CMS released an additional list of FAQs to Medicare providers regarding the HHS Provider Relief Fund and the Small Business Administration’s Paycheck Protection Program payments, also referred to as COVID-19 relief payments.  The FAQs provide guidance to providers on how to report provider relief fund payments, uninsured charges reimbursed through the Uninsured Program administered by Health Resources and Services Administration, and Small Business Administration (SBA) Loan Forgiveness amounts. The FAQs also address that provider relief fund payments should not offset expenses on the Medicare Cost Report. 

Important Note: Tax Treatment of Provider Relief Funds. According to IRS FAQs, a health care provider that receives a payment from the Provider Relief Fund may not exclude this payment from gross income as a qualified disaster relief payment under section 139 of the Internal Revenue Code. A payment to a business, even if the business is a sole proprietorship, does not qualify as a qualified disaster relief payment under section 139. The payment from the Provider Relief Fund is includible in gross income under section 61 of the Code.

The IRS also states that, in general, a tax-exempt health care provider that is described in section 501(c) of the Code generally is exempt from federal income taxation under section 501(a). Nonetheless, a payment received by a tax-exempt health care provider from the Provider Relief Fund may be subject to tax under section 511 if the payment reimburses the provider for expenses or lost revenue attributable to an unrelated trade or business as defined in section 513.

Attestation. 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 deadline to apply for funding is August 3, 2020.

The enhanced payment portal and detailed information, including terms and condition, is available here. On July 7, 2020, HRSA released a fact sheet for Medicaid and CHIP providers available on the Provider Relief Fund website. More general information about eligibility and the application process is also available on HHS’ website. CMS has also issued general COVID-19 FAQs for State Medicaid and CHIP agencies, last updated June 30th, 2020.

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 have submitted their information by June 15, 2020, at 9:00 p.m. ET.

Additional $4 Billion in Relief Payments to Hospitals (7/10/2020). On July 10, 2020, HHS announced an additional $4 billion in aid to hospitals: approximately $3 billion in funding to hospitals serving a large percentage of vulnerable populations on thin margins and approximately $1 billion to specialty rural hospitals, urban hospitals with certain rural Medicare designations, and hospitals in small metropolitan areas.

Children’s Hospitals (8/14/2020). On August 14, 2020, HHS and HRSA announced an additional $1.4 billion in targeted distribution funding to almost 80 free-standing children’s hospitals nationwide.

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 9/8/2020).

Data Submission for Performance Year 2020

On September 8, 2020, CMS updated its fact sheet on flexibilities for clinicians participating in MIPS in 2020. For the 2020 performance year CMS will be using its Extreme and Uncontrollable Circumstances policy to allow clinicians, groups and virtual groups to submit an application requesting reweighting of one or more Merit-based Incentive Payment System (MIPS) performance categories due to the current COVID-19 pandemic PHE.

CMS has likewise proposed in its 2021 Medicare Physician Fee Schedule proposed rule to allow APM Entities to submit an extreme and uncontrollable circumstances exception application for reweighting of MIPS performance categories for the 2020 performance year. If an application is approved, subsequent data submission by the APM entity would not override the approved category reweighting, a departure from the way non-APM entities are treated.

For performance year 2020, all ACOs are considered to be affected by the COVID-19 pandemic PHE, and the Shared Savings Program extreme and uncontrollable circumstances policy applies. For more information on the Shared Savings Program extreme and uncontrollable circumstances policy and its implications beyond the Quality Payment Program, please go to the Shared Savings Program webpage on CMS.gov. In addition, in the 2021 Physician Fee Schedule proposed rule, CMS proposes to waive the requirement for ACOs to field a Consumer Assessment of Healthcare Providers and Systems (CAHPS) for ACOs survey for performance year 2020. Consequently, ACOs would receive automatic full credit for the patient experience measures.

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.

Accelerated and Advanced Payment (APP) Program

On October 9, 2020, CMS announced new repayment terms for Medicare loans made to providers during COVID-19. Loan repayment will now begin one year from the issuance date of each provider or supplier’s payment. Providers were previously required to make payments starting in August of 2020.

More detail on these changes is available from this ASCO post announcing the change and CMS has provided AAP Repayment and Recovery FAQs and a related fact sheet.

On April 26, 2020, 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) 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.

FDA Actions on Drug Shortages: Temporary Compounding Policies; Updated Drug Lists; "In-use" Times

General Policies. 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.

Specific Drugs. The FDA has 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. On July 13, 2020, FDA added dexamethasone sodium phosphate to the lists of drugs for temporary compounding for hospitalized patients by outsourcing facilities and pharmacy compounders not registered as outsourcing facilities.

“In-use Times” (August 4, 2020). FDA is aware that some health care facilities and providers are facing challenges in maintaining adequate supplies of certain drugs needed to treat patients with COVID-19. The “in-use time” is the maximum amount of time that can be allowed to elapse between penetration of a container-closure system containing a sterile drug product, or after a lyophilized drug product has been reconstituted, and before patient administration.

FDA has provided a list of drugs, most used in ventilated patients, to which the following applies: 

If there is a need to use these products beyond the labeled in-use time to help ensure access to the drug for patients, it is important that this period be as short as possible, and for a maximum of:

Four (4) hours for a refrigerated storage condition (if any), or

Two (2) hours for any labeled room temperature in-use time (if any)

This extended use applies to either the refrigerated or the room temperature in-use storage condition and not both storage conditions even if both refrigerated and room temperature in-use lifetimes are provided in the labeling.

See the FDA’s webpage for important safety information and additional details.

FDA Device Shortage List. On August 14, 2020, the FDA announced the availability of its device shortage list. The device shortage list reflects the categories of devices that the FDA has determined to be in shortage at this time and will be updated as the COVID-19 pandemic evolves. In addition, the FDA is providing a list of medical devices for which manufacturing has been permanently discontinued.

Categories of devices in the device shortage list are:

  • Personal Protective Equipment
  • Testing Supplies and Equipment
  • Ventilation-Related Products

Unlike the drug shortage list maintained by the FDA, no manufacturers are identified in the device shortage list. The FDA has determined that “disclosure of the manufacturer’s name of the devices determined to be in shortage during the COVID-19 PHE will adversely affect the public health by increasing the potential for hoarding or other disruptions in device availability to patients.”

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