Regulatory Relief To Support Economic Recovery; Request for Information (RFI)

Federal RegisterNov 25, 2020

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Regulatory Relief To Support Economic Recovery; Request for Information (RFI)

AGENCY:

Office of the Secretary, Department of Health and Human Services.

ACTION:

Request for information.

SUMMARY:

Under an Executive Order that directs federal agencies to address the economic emergency created by the COVID-19 pandemic by rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery, consistent with applicable law and with protection of the public health and safety, with national and homeland security, and with budgetary priorities and operational feasibility. The Order directs agencies to “identify regulatory standards that may inhibit economic recovery” and to take appropriate action such as rescission or suspension of regulations, including by use of good cause or emergency authorities where appropriate. Agencies have likewise been called on to assess the various temporary deregulatory actions they have taken to fight COVID-19 and its impact on our economy to determine which temporary regulatory actions should be made permanent. The Order directs agencies to assist businesses and other entities in complying with the law through prompt issuance of pre-enforcement rulings and to formulate policies of enforcement discretion that recognize such entities' efforts to comply with the law.

DATES:

To be assured consideration, comments must be received at the address provided below, no later than 11:59 p.m. on December 28, 2020.

ADDRESSES:

Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Comments, including mass comment submissions, must be submitted electronically at

http://www.regulations.gov.

Follow the “Submit a comment” instructions.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

Allison Beattie, Department of Health and Human Services, 200 Independence Avenue SW, Room 713F, Washington, DC 20201. Email:

COVID.Regs@hhs.gov.

Telephone: (202) 690-7741.

SUPPLEMENTARY INFORMATION:

Executive Order 13924,

Regulatory Relief To Support Economic Recovery,

85 FR 31353 (May 19, 2020) calls on agencies to address the economic emergency caused by the COVID-19 pandemic by rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery, consistent with applicable law and with protection of the public health and safety, with national and homeland security, and with budgetary priorities and operational feasibility. To implement the directives of E.O. 13924, the U.S. Department of Health and Human Services (“HHS” or “the Department”) identified in in response to this E.O. 382 regulatory actions that it is considering to make permanent or keep as temporary made in response to the COVID-19 crisis to improve access to care and reduce costs that it is considering to make permanent or keep as temporary.

See

Attachment A (this list is not intended to be comprehensive: Additional actions have been made by the Department and will continue to occur in response to the PHE and pandemic) HHS is issuing this Request for Information (RFI) to collect information for the purpose of considering the costs and benefits, consistent with applicable law and with protection of the public health and safety, of retaining these particular regulatory changes beyond the COVID-19 public health emergency. In addition to the costs and benefits of these actions, the Department seeks input on any barriers that may exist to making these deregulatory actions permanent including any evidence or experience that commenters have.

Invitation to Comment:

HHS invites comments regarding the questions included in this notice. To ensure that your comments are clearly stated, please identify the specific question, or other section of this notice, that your comments address. Please also refer to any specific HHS policy or policies listed in the Appendix to this notice (

see

Attachment A), if applicable, by reference to the numbers associated in the Appendix with these policies.

Commenters on FDA guidance may also wish to

refer to FDA's website

COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

, available at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders and submit comments to the relevant docket associated with each guidance listed, in addition to responding to this RFI.

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:

https://www.regulations.gov.

Follow the search instructions on that website to view public comments.

I. Background

In December 2019, a novel coronavirus known as SARS-CoV-2 (“the virus”) was first noted by the People's Republic of China as having been detected in Wuhan, Hubei Province, People's Republic of China, causing an outbreak of the disease COVID-19, which has now spread globally. The Secretary of Health and Human Services declared a public health emergency (PHE) effective January 27, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19, and has extended the declaration several times, most recently on October 2, 2020 effective October 23. In Proclamation 9994 of March 13, 2020 (Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak), President Trump declared that the COVID-19 outbreak in the United States constituted a national emergency, beginning March 1, 2020.

The federal government has taken sweeping action to control the spread of the virus in the United States. HHS and its federal partners are working together with state, local, tribal and territorial governments, public health officials, healthcare providers, researchers, private sector organizations and the public to execute a whole-of-America response to the COVID-19 pandemic to protect the health and safety of the American people.

In February 2020, Secretary Azar declared that circumstances justified the authorization of emergency use for tests to detect and diagnose COVID-19. In March 2020, the Secretary declared that circumstances justified the authorization of emergency use for drugs and biological products during the COVID-19 pandemic. Emergency Use Authorizations (EUAs) allow medical countermeasures to be authorized by the U.S. Food and Drug Administration (FDA), pursuant to certain criteria, during emergencies.

Operation Warp Speed is a partnership among components of HHS, the Department of Defense, and industry

and academic partners with a goal to produce and deliver 300 million doses of safe and effective vaccines, with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).

The CDC is providing $10.25 billion to states, territories, and local jurisdictions, and the Indian Health Service is providing $750 million to tribal health programs for COVID-19 testing.

The CARES Act Provider Relief Fund supports American families, workers, and healthcare providers in the battle against the COVID-19 pandemic. HHS is distributing $175 billion to hospitals and healthcare providers on the front lines of the coronavirus response.

Coronavirus (COVID-19) Testing,

U.S. Dep't of Health and Human Serv.'s,

https://www.hhs.gov/coronavirus/testing/index.html

(last updated Aug. 19, 2020).

Fact Sheet: Explaining Operation Warp Speed,

U.S. Dep't of Health and Human Serv.'s

https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

(last updated Sep. 1, 2020).

Id.

CARES Act Provider Relief Fund,

U.S. Dep't of Health and Human Serv.'s,

https://www.hhs.gov/coronavirus/cares-act-provider-relief-fund/index.html

(last updated Aug. 14, 2020).

During the COVID-19 PHE, HHS has taken steps to make it easier to provide telehealth services so patients may receive care without going to healthcare facilities.

For example, the HHS Office for Civil Rights (OCR) has issued guidance stating that OCR will not impose penalties for violations of the HIPAA Privacy, Security, and Breach Notification Rules when healthcare providers covered by the Health Insurance Portability and Accountability Act (HIPAA) in good faith, provide telehealth services to patients using remote communication technologies, such as commonly used apps—including FaceTime, Facebook Messenger, Google Hangouts, Zoom, or Skype—for telehealth services. CMS has issued temporary measures to make it easier for people enrolled in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) to receive medical care through telehealth services during the COVID-19 PHE. It also significantly expanded the list of covered telehealth services that can be covered by Medicare providers through telehealth. During the public health emergency, Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) may serve as distant telehealth sites and provide telehealth services to patients in their homes.

Likewise, FDA established a process to more rapidly disseminate and implement agency recommendations and policies related to COVID-19.

Telehealth: Delivering Care Safely During COVID-19,

U.S. Dep't of Health and Human Serv.'s,

https://www.hhs.gov/coronavirus/telehealth/index.html

(last updated Jul. 15, 2020).

Id.

United States, Food and Drug Administration. “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019.” 85 FR 16949 (March 25, 2020).

To continue the federal response to the COVID-19 pandemic, President Trump signed Executive Order 13924 on May 19, 2020, to direct agencies to continue to remove regulatory barriers that could be stymying American economic recovery.

HHS is fulfilling this obligation by reviewing certain regulatory practices that could aid in economic recovery in ways that improve healthcare delivery.

Exec. Order No. 13924 (May 19, 2020).

II. Request for Information

To respond to the COVID-19 pandemic and its impact on the healthcare industry, HHS made changes to numerous regulations, agency guidance materials, or compliance obligations, or announced enforcement discretion (

see

Attachment A for a list of 382 of these actions) on either a temporary or permanent basis. Looking to the future, HHS intends that some of these regulatory changes (inclusive in this context of Agency guidance) will remain temporary and some will be made permanent, or permanent with modification. It may not be possible to make some of these changes permanent absent statutory changes, but HHS is still interested in comments to help us gauge the need for such changes. HHS will also consider phasing out or discontinuing regulatory changes that commenters show through evidence have negative impacts that outweigh the benefit of the regulatory change on a temporary basis or would have negative impacts that outweigh the benefits if continued beyond the PHE. Through this RFI, HHS seeks to gather feedback and relevant evidence from our stakeholders—healthcare providers and advocacy groups; industry trade groups; Medicare and Medicaid beneficiaries and caregivers; primary care and specialty providers; health insurance issuers offering health insurance coverage in the individual and group markets, group health plans sponsored by non-federal governmental entities, and supplemental insurers;

state, local, and territorial governments; research and policy experts; industry and professional associations; patients and patient advocacy groups; long-term care facilities, hospice providers, pharmacists, and pharmacy associations; nonprofit human services providers; and other interested members of the public. The information gathered in response to the RFI will be used to better inform HHS' decisions regarding which regulatory flexibilities used in the COVID-19 response should be kept temporary or made permanent. HHS and the entire U.S. government are committed to a healthy and resilient America. COVID-19 has had a sizable impact on the healthcare industry, which was forced to adjust to, among other things, remote and contactless care of patients in addition to caring for those directly affected by the virus, as well as on human services and other agencies working to promote well-being and economic mobility. Evidence-based feedback on how the 382 regulatory actions identified in Attachment A affect commenters' ability to provide or receive healthcare and services is welcome. Please note, however, that the Department may take or have taken steps to institutionalize or terminate items listed in Attachment A independent of the results of this RFI.

FAQs on Availability and Usage of Telehealth Services through Private Health Insurance Coverage in Response to Coronavirus Disease 2019 (COVID-19),

Ctrs. for Medicare & Medicaid Servs. Ctr. for Consumer Info. and Ins. Oversight (Mar. 24, 2020),

https://www.cms.gov/files/document/faqs-telehealth-covid-19.pdf.

III. Key Questions

1. Of the regulatory changes that have been made by the HHS in response to the COVID-19 PHE and the pandemic, please identify which changes;

a. Have been beneficial to healthcare or human services providers, healthcare or human services systems, or to the patients and clients using these providers and systems, and under what circumstances; or

b. Have been detrimental to healthcare or human services providers, healthcare or human services systems, or to the patients and clients using these providers and systems, and under what circumstances; or

c. Have been beneficial to healthcare or human services providers, healthcare or human services systems, or to the patients and clients using these providers and systems on a temporary basis, but would be detrimental if continued, absent the exigencies of the COVID-19 PHE and pandemic.

Please explain and provide any evidence you have of benefit or detriment.

2. Of the regulatory changes that have been made by the Department of Health and Human Services in response to the COVID-19 PHE and the pandemic, please identify which changes:

a. Should be maintained only for the duration of the PHE and pandemic;

b. Should be maintained after the expiration of the PHE or the end of the pandemic;

i.e.,

made permanent;

c. Should be extended for a period of time after the expiration of the PHE or the end of the pandemic without being made permanent;

d. Should be modified but maintained after the expiration of the PHE or the end of the pandemic, and thus made permanent with modifications, and what modifications are being proposed; or

e. Should be discontinued immediately.

Please explain and provide the rationale for your recommendation, including evidence for or against the short-term or long-term suitability of these regulatory changes. Please describe all suggested modifications for those changes that should be maintained with modification. Of the regulatory changes that have been made or been issued by the Department of Health and Human Services in response to the COVID-19 PHE, please identify which changes should be discontinued only following a transition period, and what type of transition period is recommended.

IV. Submission of Comments and Collection of Information Requirements Exemption

Commenters may respond to any and all of the key questions as they pertain to any of the regulatory changes with which commenters have experience. HHS requests that commenters provide any evidence or experience they may have to support their recommendations. HHS asks that commenters identify by number the regulatory action(s) from Attachment A to which they are responding and submit their comments to the docket associated with this notice.

Commenters may otherwise provide their responses in any format compatible with the instructions in this Request for Information they believe is appropriate for presenting their responses. Finally, HHS asks commenters to provide feedback and evidence explaining any unintended consequences of the particular regulatory actions.

Commenters on FDA guidance may also wish to

refer to FDA's website

COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

Please note, this is a RFI only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the

Federal Register

or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency's full consideration, are not generally considered information collections and therefore not subject to the PRA.

This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP), applications, proposal abstracts, or quotations. This RFI does not commit the U.S. Government to contract for any supplies or services or make a grant award. Further, we are not seeking proposals through this RFI and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. We note that not responding to this RFI does not preclude participation in any future procurement, if conducted. It is the responsibility of the potential responders to monitor this RFI announcement for additional information pertaining to this request. In addition, we note that HHS will not respond to questions about potential policy issues raised in this RFI.

We will actively consider all input as we develop future regulatory proposals or future policy guidance. We may or may not choose to contact individual responders. Such communications would be for the sole purpose of clarifying statements in the responders' written responses. Contractor support personnel may be used to review responses to this RFI. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract or issue a grant. Information obtained as a result of this RFI may be used by the Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. This RFI should not be construed as a commitment or authorization to incur cost for which reimbursement would be required or sought. All submissions become U.S. Government property and will not be returned. In addition, we may publicly post the public comments received or a summary of those public comments.

Dated: November 5, 2020.

Eric D. Hargan,

Deputy Secretary, Department of Health and Human Services.

Attachment A

Action

Agency

Sub-agency

Type of action

RIN (if applicable)

Title of action

Brief summary of action

HHS

SAMHSA

Other regulatory action

42 CFR part 2 statement

SAMHSA provided guidance as to how 42 CFR part 2 may apply during the COVID-19 emergency (

https://www.samhsa.gov/sites/default/files/covid-19-42-cfr-part-2-guidance-03192020.pdf

HHS

SAMHSA

Guidance

Take home medication

SAMHSA provided a blanket exception to opioid treatment programs to permit take-home medication for patients receiving medication-assisted treatment of up to 28 days.

HHS

OIG

Guidance

n/a

FAQs-Application of OIG's Administrative Enforcement Authorities to Arrangements Directly Connected to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

OIG is accepting inquiries from the health care community regarding the application of OIG's administrative enforcement authorities, including the Federal anti-kickback statute and civil monetary penalty (CMP) provision prohibiting inducements to beneficiaries. On this website, OIG responds to fact-specific inquiries regarding arrangements that are directly connected to the public health emergency and implicate these authorities.

HHS

OCR

Other regulatory action

Notification of Enforcement Discretion for Telehealth Remote Communications

Exercise of enforcement discretion to not impose penalties for HIPAA violations against healthcare providers in connection with their good faith provision of telehealth using remote communication technologies during the COVID-19 nationwide public health emergency.

HHS

OCR

Other regulatory action

Notification of Enforcement Discretion for Business Associates

Exercise of enforcement discretion to not impose penalties for violations of certain provisions of the HIPAA Privacy Rule against covered health care providers or their business associates for the good faith uses and disclosures of protected health information (PHI) by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.

HHS

OCR

Other regulatory action

Notification of Enforcement Discretion for Community-Based Testing Sites

Exercise of enforcement discretion to not impose penalties for violations of the HIPAA Rules against covered entities or business associates in connection with the good faith participation in the operation of COVID-19 testing sites during the COVID-19 nationwide public health emergency.

HHS

NIH

Waiver

Flexibility with System for Awards Management “SAM” Registration (2 CFR § 200.205)

Allows applicants to submit applications for Federal awards without an active SAM registration. Provided automatic extension to expiring SAM registrations.

HHS

NIH

Waiver

Flexibility with Application Deadlines (2 CFR § 200.202)

Allows agencies to accept late applications due to the COVID-19 emergency.

HHS

NIH

Waiver

Waiver for Notice of Funding Opportunities (NOFOs) Publication. (2 CFR § 200.203)

Awarding agencies can publish emergency Notice of Funding Opportunities (NOFOs) for less than thirty (30) days without separately justifying shortening the timeframe for each NOFO.

HHS

NIH

Waiver

No-cost extensions on expiring awards. (2 CFR § 200.308)

Awarding agencies may extend awards which are active as of March 31, 2020 and scheduled to expire prior or up to December 31, 2020, automatically at no-cost for a period up to twelve (12) months.

HHS

NIH

Waiver

Abbreviated non-competitive continuation requests. (2 CFR § 200.308)

For continuation requests scheduled to come in from April 1, 2020 to December 31, 2020, from projects with planned future support, awarding agencies may accept a brief statement from recipients to verify that they are in a position to: (1) Resume or restore their project activities; and (2) accept a planned continuation award.

HHS

NIH

Waiver

Allowability of salaries and other project activities. (2 CFR § 200.403, 2 CFR § 200.404, 2 CFR § 200.405)

Awarding agencies may allow recipients to continue to charge salaries and benefits to currently active Federal awards consistent with the recipients' policy of paying salaries (under unexpected or extraordinary circumstances) from all funding sources, Federal and non-Federal.

HHS

NIH

Waiver

Allowability of Costs not Normally Chargeable to Awards. (2 CFR § 200.403, 2 CFR § 200.404, 2 CFR § 200.405)

Agencies may allow recipients to charge full cost of cancellation when the event, travel, or other activities are conducted under the auspices of the grant. Awarding agencies must advise recipients that they should not assume additional funds will be available should the charging of cancellation or other fees result in a shortage of funds to eventually carry out the event or travel.

HHS

NIH

Waiver

Prior approval requirement waivers. (2 CPR § 200.407)

Awarding agencies are authorized to waive prior approval requirements as necessary to effectively address the response.

HHS

NIH

Waiver

Exemption of certain procurement requirements. (2 CPR§ 200.319(b), 2 CPR§ 200.321)

Awarding agencies may waive the procurement requirements contained in 2 CPR§ 200.319(b) regarding geographical preferences and 2 CPR§ 200.321 regarding contracting small and minority businesses, women's business enterprises, and labor surplus area firms.

HHS

NIH

Waiver

Extension of financial, performance, and other reporting. (2 CPR§ 200.327, 2 CPR§ 200.328)

Awarding agencies may allow grantees to delay submission of financial, performance and other reports up to three (3) months beyond the normal due date.

HHS

NIH

Waiver

Extension of currently approved indirect cost rates. (2 CPR§ 200.414(c))

Awarding agencies may allow grantees to continue to use the currently approved indirect cost rates (

i.e.,

predetermined, fixed, or provisional rates) to recover their indirect costs on Federal awards.

HHS

NIH

Waiver

Extension of closeout. (2 CPR§ 200.343)

Awarding agencies may allow the grantee to delay submission of any pending financial, performance and other reports required by the terms of the award for the closeout of expired projects, provided that proper notice about the reporting delay is given by the grantee to the agency.

HHS

NIH

Waiver

Extension of Single Audit submission. (2 CFR § 200.512)

Awarding agencies, in their capacity as cognizant or oversight agencies for audit, should allow recipients and subrecipients that have not yet filed their single audits with the Federal Audit Clearinghouse as of the date of the issuance of this memorandum that have fiscal year-ends through June 30, 2020, to delay the completion and submission of the Single Audit reporting package, as required under Subpart F of 2 CFR § 200.501—Audit Requirements, to six (6) months beyond the normal due date.

HHS

NIH

Waiver

OMB Memo M-20-20: Repurposing Existing Federal Financial Assistance Programs

OMB is issuing a class exception that allows Federal awarding agencies to repurpose their federal assistance awards (in whole or part) to support the COVID-19 response, as consistent with applicable laws—includes donation of personal protective equipment.

HHS

NIH

Waiver

National Research Service Awards

NIH has provided flexibility to NRSA recipients to continue charging stipends to NIH awards while no worked is performed due to COVID-19. This flexibility is in separate from salary flexibilities provided to employees of recipient institutions.

HHS

FDA

Guidance

N/A

Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability of clinical electronic thermometers to address this public health emergency.

HHS

FDA

Guidance

N/A

Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability and capability of medical x-ray, ultrasound, and magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient, healthcare provider, and healthcare technology management (HTM) exposure to COVID-19 for the duration of the COVID-19 public health emergency (PHE).

HHS

FDA

Guidance

N/A

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)

FDA issued this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering face piece respirators (including N95 respirators) for healthcare personnel (HCP)1 for the duration of the COVID-19 public health emergency.

HHS

FDA

Guidance

N/A

Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency

FDA issued this guidance to address questions FDA has received asking for clarification regarding FDA's enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency (PHE). PDMA is part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the relevant implementing regulations regarding drug samples are in 21 CFR part 203 (part 203), subpart D.

HHS

FDA

Guidance

N/A

Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic

FDA has been asked whether refrigerated food transport vehicles and refrigerated food storage units used for the temporary preservation of human remains during the COVID-19 pandemic subsequently can be used to transport and store human and animal food. FDA issued this guidance to provide information and resources related to the cleaning and disinfection of such vehicles and storage units to address food safety before they are used again to transport and store food. The recommendations in this guidance are intended to supplement existing food safety regulations and guidance.

HHS

FDA

Guidance

N/A

CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency

FDA has been closely monitoring the animal drug supply chain for supply disruptions or shortages in the United States during the COVID-19 pandemic. FDA issued this guidance to assist sponsors in providing FDA timely, informative notifications about changes in the production of animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of these products.

HHS

FDA

Guidance

N/A

CVM GFI #270—Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency

FDA issued this guidance to provide recommendations for sponsors conducting studies to support new animal drug development to help ensure the safety of animals, their owners, and study personnel, maintain compliance with good laboratory practice regulations and good clinical practice, and maintain the scientific integrity of the data during the COVID-19 pandemic.

HHS

FDA

Guidance

N/A

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry

Due to the COVID-19 pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biological products in the United States. FDA issued this guidance to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products. The guidance discusses the requirement under section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356c) and FDA's implementing regulations for applicants and manufacturers to notify FDA of a permanent discontinuance in the manufacture of certain products or an interruption in the manufacture of certain products that is likely to lead to a meaningful disruption in supply of that product in the United States. This guidance also recommends that applicants and manufacturers provide additional details and follow additional procedures to ensure FDA has the specific information it needs to help prevent or mitigate shortages. In addition, the guidance explains how FDA communicates information about products in shortage to the public.

HHS

FDA

Guidance

N/A

Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency

Due to the COVID-19 pandemic, FDA has been monitoring requests related to provisions of the Drug Supply Chain Security Act (DSCSA) because the provisions may affect the prescription drug supply chain during the COVID-19 outbreak. FDA issued this guidance to clarify the scope of the public health emergency exemption and exclusion under the DSCSA for the duration of the COVID-19 public health emergency (PHE), to help ensure adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19. In addition, this guidance announces FDA's policy regarding the exercise of its discretion in the enforcement of authorized trading partner requirements under section 582(b)(3), (c)(3), (d)(3), and (e)(3) of the FD&C Act for certain distributions during the COVID-19 PHE involving other trading partners that may not be authorized trading partners.

HHS

FDA

Guidance

N/A

Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency

FDA issued this guidance to provide a notice of exceptions and alternatives to certain requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components. This notice of exception or alternatives to certain requirements is being issued under 21 CFR 640.120(b) to respond to a national public health need and address the urgent and immediate need for blood and blood components. We expect that the alternative procedures will improve availability of blood and blood components while helping to ensure adequate protections for donor health and maintaining a safe blood supply for patients.

HHS

FDA

Guidance

N/A

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.

HHS

FDA

Guidance

N/A

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency

During the COVID-19 public health emergency, FDA has received a substantially increased volume of individual patient expanded access requests for COVID-19 investigational drugs. Although FDA has issued guidance on expanded access requests, including expanded access for individual patients, the Agency is aware that Institutional Review Boards (IRBs) seek clarity regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfill its obligations under 21 CFR part 56. Therefore, FDA issued this guidance to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.

HHS

FDA

Guidance

N/A

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

FDA issued this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

HHS

FDA

Guidance

N/A

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

FDA issued this guidance to assist sponsors in the clinical development of drugs for the treatment or prevention of COVID-19. Preventative vaccines and convalescent plasma are not within the scope of this guidance.

HHS

FDA

Guidance

N/A

Investigational COVID-19 Convalescent Plasma; Guidance for Industry (Updated: May 1, 2020)

FDA issued this guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.

HHS

FDA

Guidance

N/A

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

This revised guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. We (FDA) are also recommending that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures. This guidance also incorporates certain other recommendations related to donor educational materials and supersedes the December 2015 guidance of the same title (Notice of Availability, 80 FR 79913 (December 17, 2015)). The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma. The recommendations in this revised guidance reflect the Agency's current thinking on donor deferral recommendations for individuals with increased risk for transmitting HIV infection. Based on the Agency's careful evaluation of the available data, including data regarding the detection characteristics of nucleic acid testing, FDA expects implementation of these revised recommendations will not be associated with any adverse effect on the safety of the blood supply. Furthermore, early implementation of the recommendations in this guidance may help to address significant blood shortages that are occurring as a result of a current and ongoing public health emergency.

HHS

FDA

Guidance

N/A

Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria

The recommendations in this revised guidance reflect the Agency's current thinking on recommendations for reducing the risk of Transfusion-Transmitted Malaria (TTM). Based on the Agency's careful evaluation of the available scientific and epidemiological data on malaria risk, and data on FDA-approved pathogen reduction devices, FDA expects implementation of these revised recommendations will not be associated with any adverse effect on the safety of the blood supply. Furthermore, early implementation of the recommendations in this guidance may help to address significant blood shortages that are occurring as a result of a current and ongoing public health emergency.

HHS

FDA

Guidance

N/A

CVM GFI #269—Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak

FDA recognizes the vital role veterinarians play in protecting public health. FDA is aware that during the COVID-19 outbreak some States are modifying their requirements for veterinary telemedicine, including State requirements regarding the veterinarian-client-patient relationship (VCPR). Given that the Federal VCPR definition requires animal examination and/or medically appropriate and timely visits to the premises where the animal(s) are kept, the Federal VCPR definition cannot be met solely through telemedicine. To further facilitate veterinarians' ability to utilize telemedicine to address animal health needs during the COVID-19 outbreak, FDA intends to temporarily suspend enforcement of a portion of the Federal VCPR requirements. Specifically, FDA generally intends not to enforce the animal examination and premises visit VCPR requirements relevant to FDA regulations governing Extralabel Drug Use in Animals (21 CFR part 530) and Veterinary Feed Directive Drugs (21 CFR 558.6). Given the temporary nature of this policy, we plan to reassess it periodically and provide revision or withdrawal of this guidance as necessary.

HHS

FDA

Guidance

N/A

Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency

The Accredited Third-Party Certification Program regulation (21 CFR part 1, subpart M) establishes a voluntary program for the recognition of accreditation bodies (ABs) that accredit third-party certification bodies (CBs) to conduct food safety audits and issue food or facility certifications to eligible foreign entities for the purposes specified in sections 801(q) and 806 of the FD&C Act (21 U.S.C. 381 and 384b). The regulation requires that recognized ABs and accredited CBs perform certain onsite observations and examinations. Due to the impact of the public health emergency related to COVID-19, FDA issued this guidance to provide the Accredited Third-Party Certification Program's currently-recognized ABs and accredited CBs flexibility, in certain circumstances, regarding certain requirements.

HHS

FDA

Guidance

N/A

Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency

The purpose of this guidance is to state the current intent of the Food and Drug Administration (FDA, we, or the Agency), in certain circumstances related to the impact of the coronavirus outbreak (COVID-19), not to enforce requirements in three foods regulations to conduct onsite audits of food suppliers if other supplier verification methods are used instead. The three regulations are Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117) (“part 117”), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR part 507) (“part 507”), and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR part 1 subpart L) (“FSVP regulation”).

HHS

FDA

Guidance

N/A

Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

FDA issued this guidance to announce flexibility in the eligibility criteria for the qualified exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule) (21 CFR part 112) due to disruptions to the supply chain for the duration of the COVID-19 public health emergency.

HHS

FDA

Guidance

N/A

Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency

FDA issued this guidance to provide certain FDA-regulated food establishments (

i.e.,

human food facilities and farms, but not restaurants and retail food establishments), with a convenient mechanism to voluntarily report to FDA if they have temporarily ceased or significantly reduced production or if they are considering doing so. This reporting mechanism may also be used to request dialogue with FDA on issues related to continuing or restarting safe food production during the pandemic.

HHS

FDA

Guidance

N/A

Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency

FDA issued this guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the COVID-19 pandemic. This guidance does not apply to foods prepared by restaurants.

HHS

FDA

Guidance

N/A

Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines

FDA issued this guidance to food manufacturers to provide temporary and limited flexibilities in food labeling requirements under certain circumstances. Our goal is to provide regulatory flexibility, where fitting, to help minimize the impact of supply chain disruptions associated with the current COVID-19 pandemic on product availability. For example, we are providing flexibility for manufacturers to use existing labels, without making otherwise required changes, when making minor formula adjustments due to unforeseen shortages or supply chain disruptions brought about by the COVID-19 pandemic. Additionally, this guidance will provide temporary flexibility to the vending machine industry regarding the vending machine labeling requirements under section 403(q)(5)(H)(viii) of the FD&C Act (21 U.S.C. 343(q)(5)(H)(viii)) and 21 CFR 101.8 during the duration of the public health emergency.

HHS

FDA

Guidance

N/A

Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency

We encourage all shell egg producers to continue to comply with applicable requirements of 21 CFR part 118 (the Egg Safety Rule). However, due to the increased consumer demand for eggs in the table egg market (

e.g.,

sold directly to consumers in retail establishments), we are providing temporary flexibility to allow producers who currently only sell eggs to facilities for further processing (

e.g.,

into “egg products”) to sell to the table egg market, provided certain circumstances are present.

HHS

FDA

Guidance

N/A

Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency

HHS

FDA

Guidance

N/A

Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency

FDA issued this guidance to provide temporary flexibility regarding certain packaging and labeling requirements for shell eggs sold in retail food establishments so that industry can meet the increased demand for shell eggs during the COVID-19 pandemic.

HHS

FDA

Guidance

N/A

Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon's and patient examination gloves during this pandemic.

HHS

FDA

Guidance

N/A

Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers during this public health emergency.

HHS

FDA

Guidance

N/A

Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide recommendations for sponsors of decontamination and bioburden reduction systems about what information should be included in a pre-Emergency Use Authorization (pre-EUA) and/or EUA request to help facilitate FDA's efficient review of such request. This guidance provides these recommendations based on the device's intended use with respect to the level (tier) of decontamination or bioburden reduction, based on the sponsor's available data. Decontamination and bioburden reduction systems play an important role in the ongoing efforts to help address shortages of surgical masks and respirators intended for a medical purpose during COVID-19 or reduce the bioburden of surgical masks and filtering face piece respirators (including N95 respirators) used as personal protective equipment (PPE) by healthcare personnel for the duration of the COVID-19 public health emergency.

HHS

FDA

Guidance

N/A

Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability of digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while reducing user and healthcare provider contact and potential exposure to COVID-19 during this pandemic.

HHS

FDA

Guidance

N/A

Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to address this public health emergency.

HHS

FDA

Guidance

N/A

Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability and remote capabilities of infusion pumps and their accessories for health care professionals during the COVID-19 pandemic.

HHS

FDA

Guidance

N/A

Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability and capability of non-invasive fetal and maternal monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and potential exposure to COVID-19 during this pandemic.

HHS

FDA

Guidance

N/A

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency.

HHS

FDA

Guidance

N/A

Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides (“digital pathology slides”) during this pandemic.

HHS

FDA

Guidance

N/A

Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic.

HHS

FDA

Guidance

N/A

Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability of telethermographic systems used for body temperature measurements for triage use for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

HHS

FDA

Guidance

N/A

Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help expand the availability of ventilators as well as other respiratory devices and their accessories during this pandemic.

HHS

FDA

Guidance

N/A

Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency

FDA issued this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351 et seq.), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to device shortages and potential device shortages occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health emergency. Section 506J of the FD&C Act requires manufacturers to notify FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. This guidance is intended to assist manufacturers in providing FDA timely, informative notifications about changes in the production of certain medical device products that will help the Agency prevent or mitigate shortages of such devices during the COVID-19 public health emergency. This guidance also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during the COVID-19 public health emergency.

HHS

FDA

Guidance

N/A

COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products

FDA issued this guidance to provide general considerations to assist sponsors in preparing pre-investigational new drug application (pre-IND) meeting requests for COVID-19 related drugs for the duration of the COVID-19 public health emergency. As described in further detail in this guidance, FDA recommends that sponsors initiate all drug development interactions for COVID-19 related drugs through pre-IND meeting requests.

HHS

FDA

Guidance

N/A

Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications—Questions and Answers

FDA issued this guidance to provide answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the COVID-19 public health emergency.

HHS

FDA

Guidance

N/A

Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals

FDA issued this guidance to communicate its temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS)1 on January 31, 2020.

HHS

FDA

Guidance

N/A

Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency

FDA issued this guidance to communicate its policy for the temporary use of certain gas containers for oxygen and nitrogen intended for medical use for the duration of the current public health emergency.

HHS

FDA

Guidance

N/A

Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency

FDA issued this guidance to communicate its temporary policy regarding the repackaging or combining of propofol drug products by a licensed pharmacist in a State licensed pharmacy, a Federal facility, or an outsourcing facility registered pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b) as outlined in this guidance for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, or for such shorter time as FDA may announce through updated guidance.

HHS

FDA

Guidance

N/A

Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised)

FDA issued this guidance to communicate its temporary policy for the compounding of certain human drug products for hospitalized patients by outsourcing facilities that have registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b).

HHS

FDA

Guidance

N/A

Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry (Revised)

FDA has received a number of reports related to increased demand and supply interruptions involving FDA-approved drug products used in the treatment of hospitalized patients with COVID-19. Many of these drug products are needed to support COVID-19 patients who have been intubated, or for other procedures involved in the care of such patients. Some reports involve drug products that appear on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) (“FDA's drug shortage list”). In addition, with respect to certain other drug products needed to support hospitalized COVID-19 patients but that do not appear on FDA's drug shortage list, certain hospitals have concerns about accessing them due, for example, to regional disparities in COVID-19 infection rates, or other regional conditions that may evolve quickly during the public health emergency. FDA is working with manufacturers in the global pharmaceutical supply chain to prevent and mitigate drug shortages and access problems, using all of the Agency's authorities to restore or increase the supply of FDA-approved drug products.

HHS

FDA

Guidance

N/A

Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency

Due to the COVID-19 pandemic, FDA has received a number of queries from compounders related to the impact of supply interruptions of face masks, gowns, gloves, and other garb, which we refer to collectively in this document as

personal protective equipment (PPE).

FDA issued this guidance to communicate its temporary policy related to PPE use during human drug compounding at State-licensed pharmacies or Federal facilities that are not registered with FDA as outsourcing facilities.

HHS

FDA

Guidance

N/A

Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA issued this guidance to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the COVID-19 public health emergency.

HHS

FDA

Guidance

N/A

Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

The Agency issued this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this guidance as compounders) for the duration of the public health emergency.

HHS

FDA

Guidance

N/A

Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

FDA issued this guidance in response to a number of queries from entities that are not currently registered drug manufacturers that would like to produce alcohol (ethanol) for incorporation into alcohol-based hand sanitizers. This policy does not extend to other types of active ingredients for incorporation into alcohol-based hand sanitizers, such as isopropyl alcohol. The Agency issued this guidance to communicate its policy for the temporary manufacture of ethanol products by firms that manufacture alcohol for incorporation into alcohol-based hand sanitizer products under the circumstances described in this guidance (alcohol production firms) for the duration of the public health emergency. At such time when the public health emergency is over, as declared by the Secretary, FDA intends to discontinue this enforcement discretion policy and withdraw this guidance. FDA is continually assessing the needs and circumstances related to this temporary policy, and as relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw this policy as appropriate.

HHS

FDA

Guidance

N/A

Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

FDA issued this guidance in response to a number of queries from entities that are not currently licensed or registered drug manufacturers that would like to prepare alcohol-based hand sanitizers, either for public distribution or for their own internal use. The Agency issued this guidance to communicate its policy for the temporary preparation of certain alcohol-based hand sanitizer products by firms that register their establishment with FDA as an over-the-counter (OTC) drug manufacturer, re-packager, or re-labeler to prepare alcohol-based hand sanitizers under the circumstances described in this guidance (“firms”) for the duration of the public health emergency. At such time when the public health emergency is over, as declared by the Secretary, FDA intends to discontinue this enforcement discretion policy and withdraw this guidance.

HHS

FDA

Guidance

N/A

Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)

FDA issued this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States.

HHS

CDC

Interim Final Rule

0920-AA76

Control of Communicable Diseases; Foreign Quarantine: Suspension of Introduction of Persons into the US from Designated Foreign Countries or Places for Public Health

Suspends the introduction of persons from designated countries into the U.S. for public health reasons.

HHS

CDC

Other regulatory action

No Sail Order and Suspension of Further Embarkation

Order applies to all cruise ships that do not voluntarily suspend operation.

HHS

ACF

Guidance

New Guidance on Caseworker Visits

Modified policy to permit monthly child welfare caseworker visits to be conducted via videoconference instead of in-person; postponing title IV-E eligibility reviews and National Youth in Transition Database reviews.

HHS

ACF

Guidance

Permit provisional licensure of foster family homes

Allows for abbreviated licensing and re-licensing process for foster family homes, so that the agency does not need to assess the home's safety and appropriateness during the pandemic in as rigorous of a fashion, which requires in-person interaction.

HHS

ACF

Guidance

Permit name-based criminal background checks on prospective foster parents and other care providers

Allowed name-based background checks only, in the absence of FBI fingerprint checks, when fingerprint sites are unavailable.

HHS

ACF

Guidance

Simplify process for title IV-E assistance to youth age 18 and older

Administrative streamlining allows for quicker access to title IV-E assistance for youth who may be aging out of the child welfare system in the absence of a permanent family, using the Stafford Act.

HHS

ACF

Guidance

Modify requirement for older youth to meet education or employment requirement

Using Stafford Act flexibility, ACF temporarily waived the requirement that youth aging out of the foster care system be actively engaged in education and/or employment.

HHS

ACF

Guidance

Qualified Residential Treatment Program claiming exemption

Using Stafford Act flexibilities, this allows title IV-E agencies to continue claiming federal reimbursement for children in QRTP settings, even if the facility has not completed statutorily required accreditation due to the pandemic.

HHS

ACF

Guidance

Delegating authority to State CSBG agencies to approve equipment purchases

Same as title. Prior internal practice required federal approval for CSBG-funded equipment purchases, even when states served as pass-through entities. The authority exists for pass-through entities to approve such purchases, and ACF would further emphasize this authority and encourage pass-through entities to utilize it.

HHS

ACF

Waiver

Allowability of Costs not Normally Chargeable to Awards (Item 7 from OMB M-20-17)

Note:

Not an ACF regulation. Modify 45 CFR 75.405 (and 2 CFR 200.405) to allow the awarding agency to set an amount that may be charged that would not normally be allowed in dollar or percentage terms, with a reporting requirement if exercised. Alternatively, a class-wide exemption for CSBG may also address the issue (75.102).

HHS

ACF

Guidance

Streamlining CSBG eligibility determinations

Guidance was provided to states that streamlined certain eligibility requirements, such as attestation to, rather than production of, documentation for emergency food assistance.

HHS

ACF

Guidance

Non-Competing Continuation (NCC) Grants application

Allows abbreviated application process for grantees and eliminates burdens for non-competing continuation grant awards.

HHS

ACF

Guidance

Ability to pay salaries and other project activities

Allows programs to continue paying salaries to grantee staff during business disruptions, and activities aligned with grant purpose but not in SOW, to do so. M-20-17.

HHS

ACF

Guidance

Increase in micro-purchase threshold

HHS authorized an increase in the simplified acquisition thresholds for all COVID-19 acquisitions (to $20k for micro-purchase and $750k for simplified acquisition threshold).

HHS

ACF

Guidance

Waiver of detail and formality of acquisition plans above the simplified acquisition threshold

HHS authorized this waiver for all COVID-19 related contracts and only required them to have an informal acquisition plan.

HHS

ACF

Guidance

Flexibility with Application Deadlines (2 CFR § 200.202)

This was applied by multiple ACF programs to provide relief during the period of the pandemic by providing additional time to complete grant applications.

HHS

ACF

Guidance

Enforcement discretion for Work Participation Rate failures during the pandemic

Signals that ACF will exercise maximum enforcement discretion in levying financial penalties against states for their failure to meet the Temporary Assistance for Needy Families (TANF) program's work participation rate during the period of the pandemic, when such failure is attributable to the pandemic.

HHS

ACF

Waiver

Waiver of on-site health and safety inspections

This waived the requirement that annual inspections of child care facilities occur, with an on-site component.

HHS

ACF

Waiver

Fingerprint background check waivers

Waive the requirement that FBI fingerprint-based background checks be evaluated for child care workers, if fingerprinting sites are unavailable and name-based checks return no red flags.

HHS

ACF

Waiver

Waiver of 12 month continuing eligibility requirement

Waives the requirement that those receiving CCDF child care support retain eligibility for not less than 12 months. This was used, for example, to provide short-term eligibility for emergency workers who did not require long-term services.

HHS

ACF

Waiver

Waive co-pays for all families

Allows states to fully pay for child care costs for parents, without cost-sharing.

HHS

ACF

NPRM

Provisional hire flexibility

Waiver allowed individuals who have not completed the comprehensive (7 component) inter-state background check process to start work as child care workers, to ensure adequate staffing in emergent situations.

HHS

ACF

Other regulatory action

Grant match requirements

Provide Secretary authority to waive matching requirements in 42 U.S.C. 10407(a)(2)(A) in situations of public health emergencies.

HHS

ACF

Waiver

Waive declaration requirements for refugee assistance

Allows waiver of requirements at 45 CFR 400.43, which require written attestation and documentation of certain eligibility requirements; allows for telephonic attestation until such time as providing this documentation and written declaration is possible.

HHS

ACF

Waiver

Waive certain income requirements for refugee assistance

Allows waiver of certain components of 45 CFR 400.59 and § 400.66, such that one-time payments (

e.g.,

Economic Impact Payments) do not preclude eligibility based on income. Also, allows waiver of employment requirements at 45 CFR 400.75 when services are unavailable due to the public health emergency.

100

HHS

ACF

Waiver

Waive restrictions on Refugee Support Services funds use

Allows funds for RSS to be used to meet emergent needs associated with the COVID-19 pandemic (

e.g.,

food, shelter). Waives requirements at 45 CFR 400.146.

101

HHS

ACF

Waiver

Extend eligibility period for Refugee Supportive Services

Allows individuals receiving RSS support/services to continue receiving services if they would otherwise have exhausted the program's 60 month time limit at 45 CFR 400.152(b) during the period of the pandemic.

102

HHS

ACF

Waiver

Refugee medical screening timeframes

Waive 90 day timeline for the medical screening to take place (at 45 CFR 400.107), if that is not possible given availability of medical services. Also encourage telehealth options as alternative if in-person screening is unavailable.

103

HHS

ACF

Waiver

Permitting virtual refugee consultations

Quarterly stakeholder consultations are required in the refugee program. This flexibility allows such consultations to take place virtually rather than in-person.

104

HHS

ACF

NPRM

Various timeframe and administrative elements, Child Support Enforcement

Utilizing Stafford Act flexibilities, OCSE granted waivers to many states on a host of service-related timeline requirements (separate attachment). Some of these timelines are in regulation, but the regulations do not provide authority to waive certain regulatory provisions in other disasters or health emergency situations. This rulemaking would provide such a provision in existing regulation.

105

HHS

ACF

Other regulatory action

Raise prior approval requirement at 45 CFR § 75.407; 2 CFR § 200.407

Raise prior approval threshold for purchases from $5k to $25k in the normal course.

106

HHS

CMS

Interim Final Rule

RIN 0938-AU31

Merit-based Incentive Payment System (MIPS) Updates

BB. MIPS Improvement Activities Inventory Update to add new or make modifications to existing improvement activities in the Inventory through notice-and-comment rulemaking.

1. Table 1 in RIN 0938-AU31 outlines the new improvement activity: COVID-19 Clinical Trials.

2. To provide additional relief to individual clinicians, groups, and virtual groups for whom sufficient MIPS measures and activities may not be available for the 2019 MIPS performance period due to the PHE for the COVID-19 pandemic, extending the deadline to submit an application for reweighting the quality, cost and improvement activities performance categories based on extreme and uncontrollable circumstances from 12/31/19 to 4/30/20.

Also, modifying existing policy for the 2019 performance period/2021 MIPS payment year only.

107

HHS

CMS

Interim Final Rule

RIN 0938-AU32

Update to the Hospital Value-Based Purchasing (VBP) Program Extraordinary Circumstance Exception (ECE) Policy

The Hospital Value-Based Purchasing (VBP) Program Extraordinary Circumstance Exception (ECE) policy was revised to allow CMS to grant an exception to hospitals located in an entire region or locale without having to make an individual request and we codified the updated policy at CFR 412.165(c). This policy was updated as a permanent change in the interim final rule with comment period when it became effective on April 30, 2020.

108

HHS

CMS

Interim Final Rule

RIN 0938-AU33

Quality Reporting: Updates to the Extraordinary Circumstances Exceptions (ECE) Granted for Four Value-Based Purchasing Programs in Response to the PHE for COVID-19, and Update to the Performance Period for the FY 2022 SNF VBP Program

This IFC updates the extraordinary circumstances exceptions (ECEs) we granted on March 22, 2020 for the ESRD Quality Incentive Program (QIP), Hospital-Acquired Condition (HAC) Reduction Program, Hospital Readmissions Reduction Program, and Hospital Value-Based Purchasing (VBP) Program in response to the COVID-19 PHE, revises the FY 2022 performance period under the Skilled Nursing Facility (SNF) VBP Program as a result of the COVID-19 PHE, and changes the Extraordinary Circumstances Exception (ECE) policies for the Hospital VBP, HAC Reduction, Hospital Readmissions Reduction, ESRD QIP, and SNF VBP Programs, to provide that if, as a result of the extension of the ECE for the whole country or the submission of individual ECE requests, we do not have enough data to reliably compare national performance on measures, we would not score facilities based on such limited data or make the associated payment adjustments for the affected program year.

109

HHS

CMS

Interim Final Rule

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National Coverage Determination

National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) on Respiratory Related Devices, Oxygen and Oxygen Equipment, Home Infusion Pumps and Home Anticoagulation Therapy: Clinicians now have maximum flexibility in determining patient needs for respiratory related devices and equipment and the flexibility for more patients to manage their treatments at the home. The current NCDs and LCDs that restrict coverage of these devices and services to patients with certain clinical characteristics do not apply during the public health emergency.

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Independent Lab Payment for Specimen collection

During the PHE, Medicare established two new level II HCPCS Codes for Medicare payment of a nominal specimen collection fee and associated travel allowance. Independent labs must use one of these HCPCS codes when billing Medicare for the nominal specimen fee for COVID-19 testing for the duration of the PHE for COVID-19 pandemic.

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Communication Technology-Based Services (CTBBS)

D. Medicare routinely pays for many kinds of services that are furnished via telecommunications technology (83 FR 59482), but are not considered Medicare telehealth services. These communication technology-based services (CTBS) include, for example, certain kinds of remote patient monitoring (either as separate services or as parts of bundled services), and interpretations of diagnostic tests when furnished remotely. In the context of the PHE for the COVID-19 pandemic, when brief communications with practitioners and other non-face-to-face services might mitigate the need for an in-person visit that could represent an exposure risk for vulnerable patients, we believe that these services should be available to as large a population of Medicare beneficiaries as possible. During the PHE for the COVID-19 pandemic, we are finalizing that these services, which may only be reported if they do not result in a visit, including a telehealth visit, can be furnished to both new and established patients. Consent to receive these services can be documented by auxiliary staff under general supervision. We are finalizing on an interim basis during the PHE for the COVID-19 pandemic that, while consent to receive these services must be obtained annually, it may be obtained at the same time that a service is furnished. We are re-emphasizing that this consent may be obtained by auxiliary staff under general supervision, as well as by the billing practitioner. In the context of the PHE for the COVID-19 pandemic, where communications with practitioners might mitigate the need for an in-person visit that could represent an exposure risk for vulnerable patients, we do not believe the limitation of these services to established patients is warranted. While some of the code descriptors refer to “established patient,” during the PHE, we are exercising enforcement discretion on an interim basis to relax enforcement of this aspect of the code descriptors. We will not conduct review to consider whether those services were furnished to established patients. On an interim basis, during the PHE for the COVID-19 pandemic, we are also broadening the availability of HCPCS codes G2010 and G2012 that describe remote evaluation of patient images/video and virtual check-ins. We recognize that in the context of the PHE for the COVID-19 pandemic, practitioners such as licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech-language pathologists might also utilize virtual check-ins and remote evaluations instead of other, in-person services within the relevant Medicare benefit to facilitate the best available appropriate care while mitigating exposure risks. We note that this is not an exhaustive list and we are seeking input on other kinds of practitioners who might be furnishing these kinds of services as part of the Medicare services they furnish in the context of the PHE for the COVID-19 pandemic. To facilitate billing of the CTBS services by therapists for the reasons described above, we are designating HCPCS codes G2010, G2012, G2061, G2062, or G2063 as CTBS “sometimes therapy” services that would require the private practice occupational therapist, physical therapist, and speech-language pathologist to include the corresponding GO, GP, or GN therapy modifier on claims for these services. CTBS therapy services include those furnished to a new or established patients that the occupational therapist, physical therapist, and speech-language pathologist practitioner is currently treating under a plan of care.

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Direct Supervision by Interactive Telecommunications Technology

For the duration of the PHE for the COVID-19 pandemic, for purposes of limiting exposure to COVID-19, we adopted an interim final policy revising the definition of direct supervision to include virtual presence of the supervising physician or practitioner using interactive audio/video real-time communications technology (85 FR 19245). We recognized that in some cases, the physical proximity of the physician or practitioner might present additional infection exposure risk to the patient and/or practitioner.

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Telephone Evaluation and Management (E/M) Services Codes

S. We are finalizing, on an interim basis for the duration of the PHE for the COVID-19 pandemic, separate payment for CPT codes 98966-98968 and CPT codes 99441-99443. For these codes, we are finalizing on an interim basis for the duration of the PHE for the COVID-19 pandemic, work RVUs as recommended by the AMA Health Care Professionals Advisory Committee (HCPAC), and work RVUs as recommended by the AMA Relative Value Scale Update Committee (RUC). We are finalizing the HCPAC and RUC-recommended direct PE inputs which consist of 3 minutes of post-service RN/LPN/MTA clinical labor time for each code. Similar to the CTBS described in section II.D. of this IFC, we believe it is important during the PHE to extend these services to both new and established patients. While some of the code descriptors refer to “established patient,” during the PHE we are exercising enforcement discretion on an interim basis to relax enforcement of this aspect of the code descriptors. Specifically, we will not conduct review to consider whether those services were furnished to established patients. CPT codes 98966-98968 described assessment and management services performed by practitioners who cannot separately bill for E/Ms. We are noting that these services may be furnished by, among others, LCSWs, clinical psychologists, and physical therapists, occupational therapists, and speech language pathologists when the visit pertains to a service that falls within the benefit category of those practitioners. To facilitate billing of these services by therapists, we are designating CPT codes 98966-98968 as CTBS “sometimes therapy” services that would require the private practice occupational therapist, physical therapist, and speech-language pathologist to include the corresponding GO, GP, or GN therapy modifier on claims for these services.

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Clarification of Homebound Status under the Medicare Home Health Benefit

Homebound Definition: Broadening homebound definition to include beneficiaries whose physician advises them not to leave the home because of a confirmed or suspected COVID-19 diagnosis or if patient has a condition that makes them more susceptible to contract COVID-19.

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Use of Telecommunications Technology Under the Medicare Home Health Benefit

H. For the duration of the PHE for the COVID-19 pandemic, we are amending the hospice regulations at 42 CFR 418.204 on an interim basis to specify that when a patient is receiving routine home care, hospices may provide services via a telecommunications system if it is feasible and appropriate to do so to ensure that Medicare patients can continue receiving services that are reasonable and necessary for the palliation and management of a patients' terminal illness and related conditions without jeopardizing the patients' health or the health of those who are providing such services during the PHE for the COVID-19 pandemic. To appropriately recognize the role of technology in furnishing services under the hospice benefit, the use of such technology must be included on the plan of care. The inclusion of technology on the plan of care must continue to meet the requirements at § 418.56, and must be tied to the patient-specific needs as identified in the comprehensive assessment and the measurable outcomes that the hospice anticipates will occur as a result of implementing the plan of care. There is no payment beyond the per diem amount for the use of technology in providing services under the hospice benefit. For the purposes of the hospice claim submission, only in-person visits (with the exception of social work telephone calls) should be reported on the claim. However, hospices can report the costs of telecommunications technology used to furnish services under the routine home care level of care during the PHE for the COVID-19 pandemic as “other patient care services” using Worksheet A, cost center line 46, or a subscript of line 46 through 46.19, cost center code 4600 through 4619, and identifying this cost center as “PHE for COVID-19”.

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Use of Telecommunications Technology Under the Medicare Hospice Benefit

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Frequency Limitations on Subsequent Care Services in Inpatient and Nursing Facility Settings, and Critical Care Consultations and Required “Hands-on” Visits for ESRD Monthly Capitation Payments

B. Given our assessment that under the PHE for the COVID-19 pandemic, there is a patient population that would otherwise not have access to clinically appropriate in-person treatment, we do not believe these frequency limitations are appropriate or necessary. In our prior analysis, for example, we were concerned that patients might not receive the necessary in-person services for nursing facility or hospital inpatient services. Since in the context of this PHE, telehealth visits mitigate exposure risk, fewer in-person visits may reflect the most appropriate care, depending on the needs of individual patients. Consequently, on an interim basis, we are removing the frequency restrictions for each of the following listed codes for subsequent inpatient visits and subsequent NF visits furnished via Medicare telehealth for the duration of the PHE for the COVID-19 pandemic. Similarly, we note that we previously limited critical care consultations through telehealth to only once per day, given the patient acuity involved in critical care. However, we also understand that critical care patients have significant exposure risks such that more frequent services furnished via telehealth may reflect the best available care in the context and for the duration of the PHE for the COVID-19 pandemic. For this reason, we are also removing the restriction that critical care consultation codes may only be furnished to a Medicare beneficiary once per day. These restrictions were established through rulemaking and implemented through systems edits.

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Inpatient Hospital Services Furnished Under Arrangements Outside the Hospital

CC. Understanding that our current policy may inhibit use of capacity in settings that might otherwise be effective in the efforts to mitigate the impact of the pandemic on Medicare beneficiaries and the American public, we are changing our arrangements policy during the PHE for the COVID-19 pandemic so that hospitals are allowed broader flexibilities to furnish inpatient services, including routine services outside the hospital. We are changing our under arrangements policy during the PHE for the COVID-19 pandemic beginning March 1, 2020, so that hospitals are allowed broader flexibilities to furnish inpatient services, including routine services outside the hospital. Hospitals would be treating patients in locations outside the hospital for a variety of reasons, including limited beds and/or limited specialized equipment such as ventilators, and for a limited time period. While we are changing our under arrangements policy during the PHE for the COVID-19 pandemic to allow hospitals broader flexibilities in furnishing inpatient services, we emphasize that we are not changing our policy that a hospital needs to exercise sufficient control and responsibility over the use of hospital resources in treating patients, as discussed in the FY 2012 IPPS/LTCH PPS final rule and Section 10.3 of Chapter 5 of the Medicare General Information, Eligibility, and Entitlement Manual (Pub. 100-01). Nothing in the current PHE for the COVID-19 pandemic has changed our policy or thinking with respect to this issue and we are making no modifications to this aspect of the policy. Hospitals need to continue to exercise sufficient control and responsibility over the use of hospital resources in treating patients regardless of whether that treatment occurs in the hospital or outside the hospital under arrangements. If a hospital cannot exercise sufficient control and responsibility over the use of hospital resources in treating patients outside the hospital under arrangements, the hospital should not provide those services outside the hospital under arrangements.

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Modification of the Inpatient Rehabilitation Facility (IRF) Face-to-Face Requirement

J. During the PHE for the COVID-19 pandemic, we believe that it is essential to temporarily allow the face-to-face visit requirements at §§ 412.622(a)(3)(iv) and 412.29(e) to be conducted via telehealth to safeguard the health and safety of Medicare beneficiaries and the rehabilitation physicians treating them. This allows rehabilitation physicians to use telehealth services as defined in section 1834(m)(4)(F) of the Act, to conduct the required 3 physician visits per week during the PHE for the COVID-19 pandemic. By increasing access to telehealth, this IFC will provide the necessary flexibility for Medicare beneficiaries to be able to receive medically necessary services without jeopardizing their health or the health of those who are providing those services, while minimizing the overall risk to public health. To effectuate these changes, on an interim basis we are finalizing revisions to the regulations at §§ 412.622(a)(3)(iv) and 412.29(e) during the PHE for the COVID-19 pandemic.

In § 412.622(a)(3)(iv), we are revising this paragraph to state that physician supervision by a rehabilitation physician is required, except that during the PHE, as defined in § 400.200, such visits may be conducted using telehealth services (as defined in section 1834(m)(4)(F) of the Act).

In § 412.29(e), we are revising this paragraph to state that a procedure must be in effect to ensure that patients receive close medical supervision, as evidenced by at least 3 face-to-face visits per week by a licensed physician with specialized training and experience in inpatient rehabilitation to assess the patient both medically and functionally, as well as to modify the course of treatment as needed to maximize the patient's capacity to benefit from the rehabilitation process, except that during the PHE, as defined in § 400.200, such visits may be conducted using telehealth services (as defined in section 1834(m)(4)(F) of the Act).

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Removal of the IRF Post-Admission Physician Evaluation Requirement

K. We are removing the post-admission physician evaluation requirement at § 412.622(a)(4)(ii) for all IRFs during the PHE for the COVID-19 pandemic. We believe that removal of this requirement will greatly reduce the amount of time rehabilitation physicians in IRFs spend on completing paperwork requirements when a patient is admitted to the IRF, and will free up their time to focus instead on caring for patients and helping where they may be needed with the PHE for the COVID-19 pandemic. Accordingly, we are amending § 412.622(a)(4)(ii) to note that the post-admission physician evaluation is not required during the PHE for the COVID-19 pandemic. To effectuate this change, on an interim basis, we are revising § 412.622(a)(4)(ii) to specify that the post-admission physician evaluation is not required during the PHE for the COVID-19 pandemic.

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Requirements for Opioid Treatment Programs (OTP)

N. In light of the PHE for the COVID-19 pandemic, during which the public has been instructed to practice self-isolation or social distancing, and because interactive audio-video communication technology may not be available to all beneficiaries, we are revising § 410.67(b)(3) and (4) to allow the therapy and counseling portions of the weekly bundles, as well as the add-on code for additional counseling or therapy, to be furnished using audio-only telephone calls rather than via two-way interactive audio-video communication technology during the PHE for the COVID-19 pandemic if beneficiaries do not have access to two-way audio/video communications technology, provided all other applicable requirements are met.

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Physician Supervision Flexibility for Outpatient Hospitals—Outpatient Hospital Therapeutic Services Assigned to the Non-Surgical Extended Duration Therapeutic Services (NSEDTS) Level of Supervision

T. We changed the minimum default level of supervision to general supervision for NSEDTS during the initiation of the service to give providers additional flexibility they need to handle the burdens created by the PHE for the COVID-19 pandemic. We assigned, on an interim basis, all outpatient hospital therapeutic services that fall under § 410.27(a)(1)(iv)(E), a minimum level of general supervision to be consistent with the minimum default level of general supervision that applies for most outpatient hospital therapeutic services, and we revised § 410.27(a)(1)(iv)(E) to reflect this change in the minimum level of supervision. General supervision, as defined in our regulation at § 410.32(b)(3)(i) means that the procedure is furnished under the physician's overall direction and control, but that the physician's presence is not required during the performance of the procedure.

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Rural Health Clinics (RHC) and Federally Qualified Health Centers (FQHC) Telehealth

Allow Professionals working at Rural Health Clinics (RHCs) and Federally-Qualified Health Centers (FQHCs) to furnish telehealth services. We are expanding the services that can be included in the payment for HCPCS code G0071, and update payment rates of other codes.

We are finalizing that all virtual communication services that are billable using HCPCS code G0071 will also be available to new patients that have not been seen in the RHC or FQHC within the previous 12 months. Also, in situations where obtaining prior beneficiary consent would interfere with the timely provision of these services, or the timely provision of the monthly care management services, during the PHE for the COVID-19 pandemic consent can obtained when the services are furnished instead of prior to the service being furnished, but must be obtained before the services are billed. We will also allow patient consent to be acquired by staff under the general supervision of the RHC or FQHC practitioner for the virtual communication and monthly care management codes during the PHE for the COVID-19 pandemic.

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Change to Medicare Shared Savings Program Extreme and Uncontrollable Circumstances Policy

V. The 2019 MIPS data submission deadline will be extended by 30 days until April 30, 2020, to give eligible clinicians more time to report quality and other data for purposes of MIPS. The MIPS automatic extreme and uncontrollable circumstances policy will apply to MIPS eligible clinicians, who do not submit their MIPS data by the extended timeline. Under this automatic extreme and uncontrollable circumstances policy, MIPS eligible clinicians, who are not participants in APMs, who do not submit any MIPS data will have all performance categories reweighted to zero percent, resulting in a score equal to the performance threshold, and a neutral MIPS payment adjustment. However, under the policy, if a MIPS eligible clinician submits data on two or more MIPS performance categories, they will be scored and receive a 2021 MIPS payment adjustment based on their final score.

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Payment for Medicare Telehealth Services Under Section 1834(m) of the Act

A. To facilitate the use of telecommunications technology as a safe substitute for in-person services, we are, on an interim basis, adding many services to the list of eligible Medicare telehealth services, eliminating frequency limitations and other requirements associated with particular services furnished via telehealth, and clarifying several payment rules that apply to other services that are furnished using telecommunications technologies that can reduce exposure risks.

The list of telehealth services, including the additions described later in this section, can be located on the CMS website at

https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.

Additional CPT Codes and explanations provided in the IFC.

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Telehealth and the Medicare Hospice Face-to-Face Encounter Requirement

I. We are amending the regulations at § 418.22(a)(4) on an interim basis to allow the use of telecommunications technology by the hospice physician or NP for the face-to-face visit when such visit is solely for the purpose of recertifying a patient for hospice services during the PHE for the COVID-19 pandemic. By telecommunications technology, we mean the use of multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient (from home, or any other site permissible for receiving services under the hospice benefit) and distant site hospice physician or hospice NP.

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Home Health Orders from APPs

Z. Allow a home health patient to be under the care of a NP or clinical nurse specialist or a PA and allow such practitioner to: (1) Order home health services; (2) establish and periodically review a plan of care for home health services; and (3) certify and re-certify that the patient is eligible for Medicare home health services.

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Health Insurance Issuer Standards under the ACA, Including Standards related to Exchanges: Separate Billing and Segregation of Funds for Abortion Services

X. For Qualified health plan (QHP) issuers to devote resources to respond to the COVID-19 PHE, revising 45 CFR 156.280(e)(2)(ii) to delay implementation of the separate billing policy for 60 days from the effective date for those offering coverage of non-Hyde abortion services for the portion of their premium. Under the Program Integrity rule, issuers of individual market QHPs are required to begin separately billing policy holders for the portion of the policy holder's premium attributable to non-Hyde abortion services on or before the QHP issuer's first billing cycle following June 27, 2020. The date has been changed to the QHP issuer's first billing cycle following August 26, 2020.

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Updates to the Quality Payment Program: Merit-based Incentive Payment System (MIPS) Third Party Intermediary Approval Criteria

R. Delaying the implementation by 1 year that beginning with the 2022 performance period, QCDRs are required to collect data on a QCDR measure, appropriate to the measure type, prior to submitting the QCDR measure for CMS consideration during the self-nomination period so that they can complete QCDR measure testing and collect data.

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Application of Certain National Coverage Determination and Local Coverage Determination Requirements: CGMs

S. Continuous Glucose Monitors: CMS will not enforce certain clinical criteria in LCDs that limit access to therapeutic continuous glucose monitors for beneficiaries with diabetes.

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Reporting Requirement for Facilities to Report Nursing Home Residents and Staff Infections, Potential Infections, and Deaths

Y. Revising the requirements to establish explicit reporting requirements for confirmed or suspected cases. Specifically, we are revising our requirements by adding a new provision at § 483.80(g)(1), to require facilities to electronically report information about COVID-19 in a standardized format specified by the Secretary. The report includes, but is not limited to, information on: Suspected and confirmed COVID-19 infections among residents and staff, including residents previously treated for COVID-19; total deaths and COVID-19 deaths among residents and staff; personal protective equipment and hand hygiene supplies in the facility; ventilator capacity and supplies available in the facility; resident beds and census; access to COVID-19 testing while the resident is in the facility; staffing shortages; and other information specified by the Secretary. At § 483.80(g)(3), we are adding a new provision to require facilities to inform residents, their representatives, and families of those residing in facilities of confirmed or suspected COVID-19 cases in the facility among residents and staff. This reporting requirement supports the overall health and safety of residents by ensuring they are informed participants in the care that they receive as well as providing assurances of the mitigating steps the facility is taking to prevent and control the spread of COVID-19. Facilities must inform residents, their representatives, and families by 5 p.m. the next calendar day following the occurrence of either: A single confirmed infection of COVID-19; or three or more residents or staff with new-onset of respiratory symptoms that occur within 72 hours of each other. Also, cumulative updates to residents, their representatives, and families must be provided at least weekly by 5 p.m. the next calendar day following the subsequent occurrence of either: Each time a confirmed infection of COVID-19 is identified; or whenever three or more residents or staff with new onset of respiratory symptoms occur within 72 hours of each other.

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Delayed Adoption of the Transfer of Health (TOH) Information Measures and Standard Patient Assessment Data Elements (SPADEs)

T. We are delaying the compliance date by which IRFs, LTCH, and HHAs must collect and report data on two Transfer of Health (TOH) Information quality measures and certain Standardized Patient Assessment Data Elements (SPADEs) adopted for the IRF QRP, LTCH QRP, and HH QRP. Specifically, we will require IRFs to use IRF-PAI V4.0 and LTCHs to use LTCH CARE Data Set V5.0 to begin collecting data on the two TOH Information Measures beginning with discharges on October 1st of the year that is at least 1 full fiscal year after the end of the COVID-19 PHE. For example, if the COVID-19 PHE ends on September 20, 2020, IRFs and LTCHs will be required to begin collecting data on these measures beginning with patients discharged on October 1, 2021. We will also require IRFs and LTCHs to begin collecting data on the SPADEs for admissions and discharges (except for the hearing, vision, race, and ethnicity SPADEs, which would be collected for admissions only) on October 1st of the year that is at least 1 full fiscal year after the end of the COVID-19 PHE. HHAs will be required to use OASIS-E to begin collecting data on the two TOH Information Measures beginning with discharges and transfers on January 1st of the year that is at least 1 full calendar year after the end of the COVID-19 PHE. For example, if the COVID-19 PHE ends on September 20, 2020, HHAs will be required to begin collecting data on those measures beginning with patients discharged or transferred on January 1, 2022.

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Care Planning for Medicare Home Health Services

J. NPs, CNSs, and PAs would be able to practice to the top of their state licensure to certify eligibility for home health services, as well as establish and periodically review the home health plan of care. We are also amending the regulations at parts 409, 424, and 484 to define a NP, a CNS, and a PA (as such qualifications are defined at §§ 410.74 through 410.76) as an “allowed practitioner”. This means that in addition to a physician, as defined at section 1861(r) of the Act, an “allowed practitioner” may certify, establish and periodically review the plan of care, as well as supervise the provision of items and services for beneficiaries under the Medicare home health benefit. Additionally, we are amending the regulations to reflect that we would expect the allowed practitioner to also perform the face-to-face encounter for the patient for whom they are certifying eligibility; however, if a face-to-face encounter is performed by an allowed NPP, as set out at 42 CFR 424.22(a)(1)(v)(A), in an acute or post-acute facility, from which the patient was directly admitted to home health, the certifying practitioner may be different from the provider performing the face-to-face encounter. These regulation changes will become permanent and are not time limited to the period of the PHE for COVID-19.

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Inpatient Rehabilitation—Intensity of Therapy Requirement (“3-Hour Rule”) and Related IRF Coverage Requirements

K. In the March 31st COVID-19 IFC (85 FR 19252, 19287), we provided a clarification regarding § 412.622(a)(3)(ii) (commonly referred to as the “3-hour rule”). On March 27, 2020, the CARES Act was enacted and further addressed § 412.622(a)(3)(ii). Specifically, section 3711(a) of the CARES Act requires the Secretary to waive § 412.622(a)(3)(ii) during the emergency period described in section 1135(g)(1)(B) of the Act. This waiver was issued on April 15 2020, and is available at

https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.

We note that the clarification provided in the March 31st COVID-19 IFC does not address section 3711(a) of the CARES Act as it was developed prior to the enactment of the CARES Act. Because § 412.622(a)(3)(ii) is more directly and comprehensively addressed by section 3711(a) of the CARES Act, the clarification provided in the March 31st COVID-19 IFC is moot and hereby rescinded.

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IRF Coverage Criteria—Surge Capacity

C. We are amending § 412.622(a)(3)(i), (ii), (iii), and (iv) to state that these IRF coverage criteria continue to be required, except for care furnished to patients in a freestanding IRF hospital solely to relieve acute care hospital capacity in a state (or region, as applicable) that is experiencing a surge during the PHE, as defined in § 400.200. Similarly, in § 412.622(a)(4), we are amending this paragraph to state that the IRF documentation requirements must be present in the IRF medical record, except for care furnished to patients in a freestanding IRF hospital solely to relieve acute care hospital capacity in a state (or region, as applicable) that is experiencing a surge during the PHE, as defined in § 400.200. In § 412.622(a)(5), we are amending this paragraph to state that an interdisciplinary team approach to care is required, except for care furnished to patients in a freestanding IRF hospital solely to relieve acute care hospital capacity in a state (or region, as applicable) that is experiencing a surge during the PHE, as defined in § 400.200.

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Laboratory Tests: Payment for COVID-19 Specimen Collection to Physicians, Non-Physician Practitioners and Hospitals

BB. We are providing additional payment for assessment and COVID-19 specimen collection to support testing by HOPDs, and physicians and other practitioners, to recognize the significant resources involved in safely collecting specimens from many beneficiaries during a pandemic. We are also allowing physicians and practitioners to bill for services provided by clinical staff to assess symptoms and take specimens for COVID-19 laboratory testing for all patients, not just established patients. We are creating and updating payment codes to account for these changes.

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Indirect Medical Education

Indirect Medical Education. Beds temporarily added during the COVID-19 PHE do not reduce a teaching hospital's Indirect Medical Education payments.

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Medical Education: Time Spent by Residents at Another Hospital during the COVID-19 PHE

Direct Graduate Medical Education and Indirect Medical Education. During the COVID-19 PHE, hospitals may claim time spent by residents training at another hospital so that a hospital which sends residents to another hospital can claim those FTE residents on its Medicare cost report while they are training at another hospital in its FTE count, if certain conditions are met. Also the presence of residents in the receiving hospital would not trigger per-resident amounts.

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Medicare Shared Savings Programs

L. We are modifying Shared Savings Program policies to: (1) Allow ACOs whose current agreement periods expire on December 31, 2020, the option to extend their existing agreement period by 1-year, and allow ACOs in the BASIC track's glide path the option to elect to maintain their current level of participation for PY 2021; (2) clarify the applicability of the program's extreme and uncontrollable circumstances policy to mitigate shared losses for the period of the COVID-19 PHE; (3) adjust program calculations to mitigate the impact of COVID-19 on ACOs; and (4) expand the definition of primary care services for purposes of determining beneficiary assignment to include telehealth codes for virtual check-ins, e-visits, and telephonic communication. We are revising our policies under the Shared Savings Program to exclude from Shared Savings Program calculations all Parts A and B FFS payment amounts for an episode of care for treatment of COVID-19, triggered by an inpatient service, and as specified on Parts A and B claims with dates of service during the episode. We are relying on our authority under section 1899(d)(1)(B)(ii) of the Act to adjust benchmark expenditures for other factors in order to remove COVID-19-related expenditures from the determination of benchmark expenditures. As discussed elsewhere in this section, we are also exercising our authority under section 1899(i)(3) of the Act to apply this adjustment to certain other program calculations, including the determination of performance year expenditures.

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Opioid Treatment Programs (OTP)—Furnishing Periodic Assessments via Communication Technology

D. Allow telehealth in place of required visits for opioid treatment programs (OTP).

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Furnishing Hospital Outpatient Services Remotely

F. Hospital and CMHC staff can furnish certain outpatient therapy, counseling, and educational services (including PHP services) incident to a physician's service during the COVID-19 PHE to a beneficiary in their home or other temporary expansion location using telecommunications technology. In these circumstances, the hospital can furnish services to a beneficiary in a temporary expansion location (including the beneficiary's home) if that beneficiary is registered as an outpatient; and the CMHC can furnish services in an expanded CMHC (including the beneficiary's home) to a beneficiary who is registered as an outpatient. We also clarified that hospitals can furnish clinical staff services (for example, drug administration) in the patient's home, which is considered provider-based to the hospital during the COVID-19 PHE, and to bill and be paid for these services when the patient is registered as a hospital outpatient. Further, we clarified that when a patient is receiving a professional service via telehealth in a location that is considered a hospital PBD, and the patient is a registered outpatient of the hospital, the hospital in which the patient is registered may bill the originating site facility fee for the service. Finally, we clarified the applicability of section 603 of the BBA 2015 to hospitals furnishing care in the beneficiaries' homes (or other temporary expansion locations), and whether those locations are considered relocated, partially relocated, or new PBDs.

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Treatment of New and Certain Relocating Provider-Based Departments

E. We are adopting a temporary extraordinary circumstances relocation exception policy for excepted off-campus PBDs that relocate off-campus during the COVID-19 PHE. We are extending that temporary policy to on-campus PBDs that relocate off-campus during the COVID-19 PHE, and permitting the relocating PBDs to continue to be paid under the OPPS. Finally, we are streamlining the process for relocating PBDs to obtain the temporary extraordinary circumstances policy exception.

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Payment for Remote Physiologic Monitoring (RPM) Services

CC. We are establishing a policy on an interim final basis for the duration of the COVID-19 PHE to allow RPM codes to be billed for a minimum of 2 days of data collection over a 30-day period, rather than the required 16 days of data collection over a 30-day period as provided in the CPT code descriptors.

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Rural Health Clinics (RHC)

H. Due to the COVID-19 pandemic, health care providers such as hospitals have been or are planning to increase inpatient bed capacity to address the surge in need for inpatient care. Given this, we do not believe that RHCs that are currently exempt from the national per-visit payment limit should now be subject to the per-visit payment limit due to the COVID-19 PHE, and we do not want to discourage them from increasing bed capacity if needed. Allowing for these provider-based RHCs to continue to receive the payment amounts they would otherwise receive in the absence of the PHE will help maintain their ability to provide necessary health care services to underserved communities. We are implementing, on an interim basis, a change to the period of time used to determine the number of beds in a hospital at § 412.105(b) for purposes of determining which provider-based RHCs are subject to the payment limit. For the duration of the PHE, we will use the number of beds from the cost reporting period prior to the start of the PHE as the official hospital bed count for application of this policy. As such, RHCs with provider-based status that were exempt from the national per-visit payment limit in the period prior to the effective date of the PHE (January 27, 2020) would continue to be exempt for the duration of the PHE for the COVID-19 pandemic, as defined at § 400.200.

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RIN 0938-AU31

Scope of Practice: Supervision of Diagnostic Tests by Certain Non-Physician Practitioners

Allow nurse practitioners (NPs), clinical nurse specialists (CNSs), physician assistants (PAs) and certified nurse-midwives (CNMs) to supervise the performance of diagnostic tests in addition to physicians.

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Scope of Practice: Pharmacists Working Incident to a Physicians' Service

B. 4. We are clarifying explicitly that pharmacists fall within the regulatory definition of auxiliary personnel under our regulations at § 410.26. As such, pharmacists may provide services incident to the services, and under the appropriate level of supervision, of the billing physician or NPP, if payment for the services is not made under the Medicare Part D benefit. This includes providing the services incident to the services of the billing physician or NPP and in accordance with the pharmacist's state scope of practice and applicable state law.

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RIN 0938-AU31

COVID-19 Serology Testing

Section V of the rule. Antibody Testing: Medicare will cover certain serology (antibody) tests, which may aid in determining whether a person may have developed an immune response and may not be at immediate risk for COVID-19 reinfection. FDA approved or cleared COVID-19 serology testing as a Medicare covered diagnostic test for patients that have reason to believe they have been exposed to COVID-19. The serology test for COVID-19 is a covered service under Medicare Parts A and B and may be considered a hospital service (section 1861(b) of the Act) or diagnostic laboratory test (section 1861(s)(3) of the Act).

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RIN 0938-AU31

Additional Flexibility under the Teaching Physician Regulations

M. Allow the teaching physician to meet the requirement to review the service with the resident, during or immediately after the visit, through virtual or remote means via interactive audio/video real-time communications technology. Given the circumstances of the COVID-19 PHE, the teaching physician may be under quarantine or otherwise not physically available to review the service with the resident. We are reinstating the former paragraph (b) and adding a new paragraph (c) to allow that, on an interim basis for the duration of the PHE for the COVID-19 pandemic, the teaching physician may not only direct the care furnished by residents, but also review the services provided with the resident, during or immediately after the visit, remotely through virtual means via audio/video real time communications technology.

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Updating the Medicare Telehealth List on a Sub-regulatory Basis

AA. Due to the urgency of minimizing unnecessary contact between beneficiaries and practitioners, we believe that, for purposes of the PHE for the COVID-19 pandemic, we should modify the process we established for adding or deleting services from the Medicare telehealth services list under our regulation at § 410.78(f) to allow for an expedited process during the PHE that does not involve notice and comment rulemaking. Therefore, for the duration of the PHE for the COVID-19 pandemic, we are revising our regulation at § 410.78(f) to specify that, during a PHE, as defined in § 400.200 of this chapter, we will use a subregulatory process to modify the services included on the Medicare telehealth list.

While we are not codifying a specific process to be in effect during the PHE for the COVID-19 pandemic, we note that we could add services to the Medicare telehealth list on a subregulatory basis by posting new services to the web listing of telehealth services when the agency receives a request to add (or identifies through internal review) a service that can be furnished in full, as described by the relevant code, by a distant site practitioner to a beneficiary in a manner that is similar to the in-person service. We also note that any additional services added using the revised process would remain on the list only during the PHE for the COVID-19 pandemic.

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Therapy—Therapy Assistants Furnishing Maintenance Therapy (PFS)

B. 2. To increase availability of needed health care services during the COVID-19 PHE, we believe it is appropriate to synchronize our Part B payment policies as suggested by the stakeholders, and to permit the PT or OT who established the maintenance program to delegate the performance of maintenance therapy services to a PTA or OTA when clinically appropriate. We believe that, by allowing PTAs and OTAs to perform maintenance therapy services, PTs and OTs will be freed up to furnish other services, including such services as non-medication pain management therapies that may reduce reliance on opioids or other medications, as well as those services related to the COVID-19 PHE that require a therapist's assessment and evaluation skills, including communication technology-based services (CTBS) that were made available for PTs, OTs and speech-language pathologists (SLPs) during the PHE in the March 31st COVID-19 IFC (85 FR 19245 and 19265 through 19266).

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Modification to Medicare Provider Enrollment Provision Concerning Certification of Home Health Services

W. Several of our previous provider enrollment rulemaking efforts have focused on strengthening existing enrollment procedures and eliminating existing vulnerabilities; in other words, the objectives have been to enhance our ability to: (1) Conduct strict screening activities; (2) take prompt action against problematic providers and suppliers; and (3) implement important safeguards against improper Medicare payments. Yet we believe that the current COVID-19 PHE requires us to undertake provider enrollment rulemaking for a different reason; specifically, the need to help providers and suppliers concentrate their resources on treating those beneficiaries affected by COVID-19. Therefore, as discussed in section III. of this IFC, “Waiver of Proposed Rulemaking,” we believe the urgency of this COVID-19 PHE constitutes good cause to waive the normal notice-and-comment process under the Administrative Procedure Act and statute. Accordingly, this IFC contains an important revision to part 424, subpart P that will give providers and suppliers certain flexibilities in their activities during the existing COVID-19 PHE. Section 3708 of the CARES Act made several important amendments to sections 1814(a)(2) and 1835(a)(2) of the Act (as well as other related sections of the statute). One amendment was that NPs, CNSs, and PAs (as those terms are defined in section 1861(aa)(5) of the Act) working in accordance with state law may also certify the need for home health services. Section 3708(f) of the CARES Act authorizes us to promulgate an interim final rule, if necessary, to implement the provisions in section 3708 by the statutory deadline. Further, given the need for flexibility in the provision of health care services in the COVID-19 PHE, we believe it is appropriate to implement these statutory changes in this IFC, rather than through notice-and-comment rulemaking. Consequently, we are revising § 424.507(b)(1) to include ordering/certifying physicians, PAs, NPs, and CNSs as individuals who can certify the need for home health services. We note that, for reasons similar to those related to our other modifications to Medicare rules concerning the certification and provision of home health services, this change to § 424.507 is final and applicable to services provided on or after March 1, 2020.We will review and respond to any comments thereon in the CY 2021 HH PPS final rule or in another future rule.

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Waiver

Verbal Orders

Waiving the requirements of 42 CFR § 482.23, § 482.24 and § 485.635(d)(3) to provide additional flexibility related to verbal orders where read-back verification is required, but authentication may occur later than 48 hours. This will allow more efficient treatment of patients in surge situations.

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Waiver

Medical Records

Waiving requirements under 42 CFR § 482.24(a) through (c), which cover the subjects of the organization and staffing of the medical records department, requirements for the form and content of the medical record, and record retention requirements, and these flexibilities may be implemented so long as they are not inconsistent with a state's emergency preparedness or pandemic plan. CMS is waiving § 482.24(c)(4)(viii) related to medical records to allow flexibility in completion of medical records within 30 days following discharge from a hospital. This flexibility will allow clinicians to focus on the patient care at the bedside during the pandemic. CMS is waiving § 482.24(c)(4)(viii) related to medical records to allow flexibility in completion of medical records within 30 days following discharge from a hospital. This flexibility will allow clinicians to focus on the patient care at the bedside during the pandemic.

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Waiver

Nursing Care Plan

Waiving the requirements at 42 CFR § 482.23(b)(4), which requires the nursing staff to develop and keep current a nursing care plan for each patient, and § 482.23(b)(7), which requires the hospital to have policies and procedures in place establishing which outpatient departments are not required to have a registered nurse present. These waivers allow nurses increased time to meet the clinical care needs of each patient and allow for the provision of nursing care to an increased number of patients. In addition, we expect that hospitals will need relief for the provision of inpatient services and as a result, the requirement to establish nursing-related policies and procedures for outpatient departments is likely of lower priority. These flexibilities apply to both hospitals and CAHs § 485.635(d)(4), and may be implemented so long as they are not inconsistent with a state's emergency preparedness or pandemic plan.

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Waiver

Upkeep of current therapeutic diet manual

Food and Dietetic Services—Manual. CMS is waiving the requirement at paragraph 42 CFR § 482.28(b)(3), which requires providers to have a current therapeutic diet manual approved by the dietitian and medical staff readily available to all medical, nursing, and food service personnel. Such manuals would not need to be maintained at surge capacity sites. These flexibilities may be implemented so long as they are not inconsistent with a state's emergency preparedness or pandemic plan. Removing these administrative requirements will allow hospitals to focus more resources on providing direct patient care.

156

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Waiver

Written policies and procedures for appraisal of emergencies at off campus hospital departments

Waiving 42 CFR § 482.12(f)(3), emergency services, with respect to surge facilities only, such that written policies and procedures for staff to use when evaluating emergencies are not required for surge facilities. This removes the burden on facilities to develop and establish additional policies and procedures at their surge facilities or surge sites related to the assessment, initial treatment, and referral of patients. These flexibilities may be implemented so long as they are not inconsistent with a state's emergency preparedness or pandemic plan.

157

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Waiver

Emergency Preparedness Policies and Procedures

Waiving 42 CFR § 482.15(b) and § 485.625(b), which requires the hospital and CAH to develop and implement emergency preparedness policies and procedures, and § 482.15(c)(1)-(5) and § 485.625(c)(1)-(5) which requires that the emergency preparedness communication plans for hospitals and CAHs to contain specified elements with respect to the surge site. The requirement under the communication plan requires hospitals and CAHs to have specific contact information for staff, entities providing services under arrangement, patients' physicians, other hospitals and CAHs, and volunteers. This would not be an expectation for the surge site. This waiver applies to both hospitals and CAHs, and removes the burden on facilities to establish these policies and procedures for their surge facilities or surge sites.

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Waiver

Emergency Preparedness

CMS is waiving the requirements at 42 CFR § 494.62(d)(1)(iv) which requires ESRD facilities to demonstrate as part of their Emergency Preparedness Training and Testing Program, that staff can demonstrate that, at a minimum, its patient care staff maintains current CPR certification. CMS is waiving the requirement for maintenance of CPR certification during the COVID-19 emergency due to the limited availability of CPR classes.

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Waiver

Reporting Requirements

Waiving the requirements at 42 CFR § 482.13(g)(1)(i)-(ii), which require that hospitals report patients in an intensive care unit whose death is caused by their disease, but who required soft wrist restraints to prevent pulling tubes/IVs, no later than the close of business on the next business day. Due to current hospital surge, CMS is waiving this requirement to ensure that hospitals are focusing on increased patient care demands and increased patient census, provided any death where the restraint may have contributed is still reported within standard time limits (

i.e.,

close of business on the next business day following knowledge of the patient's death).

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Waiver

Extension for Inpatient Prospective Payment System (IPPS) Wage Index Occupational Mix Survey Submission

CMS collects data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program. Completed 2019 Occupational Mix Surveys, Hospital Reporting Form CMS-10079, for the Wage Index Beginning FY 2022, are due to the Medicare Administrative Contractors (MACs) on the Excel hospital reporting form available at

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files.html

by July 1, 2020. CMS is currently granting an extension for hospitals nationwide affected by COVID-19 until August 3, 2020. If hospitals encounter difficulty meeting this extended deadline date, hospitals should communicate their concerns to CMS via their MAC, and CMS may consider an additional extension if CMS determines it is warranted.

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Waiver

HHA Reporting

CMS is providing relief to HHAs on the timeframes related to OASIS Transmission through the following actions below:

• Extending the 5-day completion requirement for the comprehensive assessment to 30 days.

• Waiving the 30-day OASIS submission requirement. Delayed submission is permitted during the PHE.

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Waiver

SNF Reporting Minimum Data Set

Waiving 42 CFR 483.20 to provide relief to SNFs on the timeframe requirements for Minimum Data Set assessments and transmission.

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Waiver

SNF Staffing Data Submission

Waiving 42 CFR 483.70(q) to provide relief to long-term care facilities on the requirements for submitting staffing data through the Payroll-Based Journal system.

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Waiver

Physical Environment.

CMS is waiving certain requirements under the Medicare conditions of participation at 42 CFR § 482.41 and § 485.623 to allow for flexibilities during hospital, psychiatric hospital, and CAH surges. CMS will permit non-hospital buildings/space to be used for patient care and quarantine sites, provided that the location is approved by the state (ensuring that safety and comfort for patients and staff are sufficiently addressed) and so long as it is not inconsistent with a state's emergency preparedness or pandemic plan.

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Waiver

CAH Status and Location

Waiving the requirement at 42 CFR § 485.610(b) that the CAH be located in a rural area or an area being treated as being rural, allowing the CAH flexibility in the establishment of surge site locations. CMS is also waiving the requirement at § 485.610(e) regarding the CAH's off-campus and co-location requirements, allowing the CAH flexibility in establishing temporary off-site locations. In an effort to facilitate the establishment of CAHs without walls, these waivers will suspend restrictions on CAHs regarding their rural location and their location relative to other hospitals and CAHs. These flexibilities may be implemented so long as they are not inconsistent with a state's emergency preparedness or pandemic plan.

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Waiver

Hospitals Classified as Sole Community Hospitals (SCH)

Waiving certain eligibility requirements at 42 CFR § 412.92(a) for hospitals classified as SCHs prior to the PHE. Specifically, CMS is waiving the distance requirements at paragraphs (a), (a)(1), (a)(2), and (a)(3) of 42 CFR § 412.92, and is also waiving the “market share” and bed requirements (as applicable) at 42 CFR § 412.92(a)(1)(i) and (ii). CMS is waiving these requirements for the duration of the PHE to allow these hospitals to meet the needs of the communities they serve during the PHE, such as to provide for increased capacity and promote appropriate cohorting of COVID-19 patients. MACs will resume their standard practice for evaluation of all eligibility requirements after the conclusion of the PHE period.

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Waiver

RHC and FQHC Temporary Expansion Locations

Waiving the requirements at 42 CFR § 491.5(a)(3)(iii) which require RHCs and FQHCs be independently considered for Medicare approval if services are furnished in more than one permanent location. Due to the current PHE, CMS is temporarily waiving this requirement removing the location restrictions to allow flexibility for existing RHCs/FQHCs to expand services locations to meet the needs of Medicare beneficiaries. This flexibility includes areas which may be outside of the location requirements 42 CFR § 491.5(a)(1) and (2) but will end when the HHS Secretary determines there is no longer a PHE due to COVID-19.

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Waiver

Care for Excluded Inpatient Psychiatric and Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a Hospital

CMS is allowing acute care hospitals with excluded distinct part inpatient psychiatric units and inpatient rehabilitation units to relocate inpatients from the excluded distinct part psychiatric unit or inpatient rehabilitation unit to an acute care bed and unit as a result of a disaster or emergency. The hospital should continue to bill for inpatient psychiatric services or inpatient rehabilitation services under the Inpatient Psychiatric Facility Prospective Payment System or Inpatient Rehabilitation Facility Prospective Payment System for these patients and annotate the medical record to indicate the patient is a psychiatric inpatient being cared for in an acute care bed because of capacity or other exigent circumstances related to the COVID-19 emergency. This waiver may be utilized where the hospital's acute care beds are appropriate for psychiatric patients or rehabilitation patients and the staff and environment are conducive to safe care. For psychiatric patients, this includes assessment of the acute care bed and unit location to ensure those patients at risk of harm to self and others are safely cared for.

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Waiver

Specific Life Safety Code (LSC) Waivers for Multiple Providers: Temporary Construction

CMS is waiving requirements that would otherwise not permit temporary walls and barriers between patients.

Refer to: 2012 LSC, sections 18/19.3.3.2.

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Waiver

Community Mental Health Clinics (CMHC) Provision of Service

42 CFR 485.918(b)(1)(iii). We are waiving the specific requirement at § 485.918(b)(1)(iii) that prohibits CMHCs from providing partial hospitalization services and other CMHC services in an individual's home so that clients can safely shelter in place during the PHE while continuing to receive needed care and services from the CMHC. This waiver is a companion to recent regulatory changes that clarify how CMHCs should bill for services provided in an individual's home, and how such services should be documented in the medical record. While this waiver will now allow CMHCs to furnish services in client homes, including through the use of using telecommunication technology, CMHCs continue to be, among other things, required to comply with the nonwaived provisions of 42 CFR Part 485, Subpart J, requiring that CMHCs: (1) Assess client needs, including physician certification of the need for partial hospitalization services, if needed; (2) implement and update each client's individualized active treatment plan that sets forth the type, amount, duration, and frequency of the services; and (3) promote client rights, including a client's right to file a complaint.

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Waiver

RAPs

CMS is allowing Medicare Administrative Contractors (MACs) to extend the auto-cancellation date of Requests for Anticipated Payment (RAPs) during emergencies.

172

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Waiver

Utilization Review (UR)

CMS is waiving certain requirements under 42 CFR § 482.1(a)(3) and 42 CFR § 482.30 which address the statutory basis for hospitals and includes the requirement that hospitals participating in Medicare and Medicaid must have a utilization review plan that meets specified requirements.

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Waiver

Training Program and Periodic Audits

CMS is waiving the requirement at 42 CFR § 494.40(a) related to the condition on Water & Dialysate Quality, specifically that on-time periodic audits for operators of the water/dialysate equipment are waived to allow for flexibilities.

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Waiver

Appeals Extensions

CMS is allowing Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) in the FFS program pursuant to 42 CFR § 405.942 and 42 CFR § 405.962 (including for MA and Part D plans), as well as the MA and Part D Independent Review Entities (IREs) under 42 CFR § 422.562, 42 CFR § 423.562, 42 CFR § 422.582 and 42 CFR § 423.582, to allow extensions to file an appeal. CMS is allowing MACs and QICs in the FFS program under 42 CFR § 405.950 and 42 CFR § 405.966 and the MA and Part D IREs to waive requests for timeliness requirements for additional information to adjudicate appeals.

• CMS is allowing MACs and QICs in the FFS program under 42 CFR § 405.910 and MA and Part D plans, as well as the MA and Part D IREs, to process an appeal even with incomplete Appointment of Representation forms as outlined under 42 CFR § 422.561 and 42 CFR § 423.560. However, any communications will only be sent to the beneficiary.

• CMS is allowing MACs and QICs in the FFS program under 42 CFR § 405.950 and 42 CFR § 405.966 (also including MA and Part D plans), as well as the MA and Part D IREs, to process requests for appeals that do not meet the required elements using information that is available as outlined within 42 CFR § 422.561 and 42 CFR § 423.560.

• CMS is allowing MACs and QICs in the FFS program under 42 CFR § 405.950 and 42 CFR § 405.966 (also including MA and Part D plans), as well as the MA and Part D IREs under 42 CFR § 422.562 and 42 CFR § 423.562 to utilize all flexibilities available in the appeal process as if good cause requirements are satisfied.

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Waiver

Risk Adjusted Factor (RAF) Extensions

CMS is allowing MACs and QICs in the FFS program 42 CFR 405.950 and 42 CFR 405.966 and the Part C and Part D IREs to waive requirements for timeliness for requests for additional information to adjudicate appeals; MA plans may extend the timeframe to adjudicate organization determinations and reconsiderations for medical items and services (but not Part B drugs) by up to 14 calendar days if: The enrollee requests the extension; the extension is justified and in the enrollee's interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization's decision to deny an item or service; or, the extension is justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee's interest 42 CFR § 422.568(b)(1)(i), § 422.572(b)(1) and § 422.590(f)(1).

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Waiver

SNF 3-Day Prior Hospitalization and 60-day “wellness period”

Using the authority under Section 1812(f) of the Act, CMS is waiving the requirement for a 3-day prior hospitalization for coverage of a SNF stay, which provides temporary emergency coverage of SNF services without a qualifying hospital stay, for those people who experience dislocations, or are otherwise affected by COVID-19. In addition, for certain beneficiaries who recently exhausted their SNF benefits, it authorizes a one-time renewal of SNF coverage without first having to start a new benefit period (this waiver will apply only for those beneficiaries who have been delayed or prevented by the emergency itself from commencing or completing the process of ending their current benefit period and renewing their SNF benefits that would have occurred under normal circumstances).

177

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Waiver

Supporting Care for Patients in Long-Term Care Acute Hospitals (LTCHs)

CMS has determined it is appropriate to issue a blanket waiver to long-term care hospitals (LTCHs) to exclude patient stays where an LTCH admits or discharges patients in order to meet the demands of the emergency from the 25-day average length of stay requirement, which allows these facilities to be paid as LTCHs. In addition, during the applicable waiver time period, we would also apply this waiver to facilities not yet classified as LTCHs, but seeking classification as an LTCH.

178

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Waiver

CAH Bed Count and Length of Stay

Waiving the requirements that CAHs limit the number of beds to 25, and that the length of stay be limited to 96 hours under the Medicare conditions of participation for number of beds and length of stay at 42 CFR § 485.620.

179

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Waiver

Hospitals Classified as Medicare-Dependent, Small Rural Hospitals (MDH)

For hospitals classified as MDHs prior to the PHE, CMS is waiving the eligibility requirement at 42 CFR § 412.108(a)(1)(ii) that the hospital has 100 or fewer beds during the cost reporting period, and the eligibility requirement at 42 CFR § 412.108(a)(1)(iv)(C) that at least 60 percent of the hospital's inpatient days or discharges were attributable to individuals entitled to Medicare Part A benefits during the specified hospital cost reporting periods. CMS is waiving these requirements for the duration of the PHE to allow these hospitals to meet the needs of the communities they serve during the PHE, such as to provide for increased capacity and promote appropriate cohorting of COVID-19 patients. MACs will resume their standard practice for evaluation of all eligibility requirements after the conclusion of the PHE period.

180

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Waiver

Hospice Aide Competency testing Allow Use of Pseudo Patients

Temporarily modifying the requirement in § 418.76(c)(1) that a hospice aide must be evaluated by observing an aide's performance of certain tasks with a patient. This modification allows hospices to utilize pseudo patients such as a person trained to participate in a role-play situation or a computer-based mannequin device, instead of actual patients, in the competency testing of hospice aides for those tasks that must be observed being performed on a patient. This increases the speed of performing competency testing and allows new aides to begin serving patients more quickly without affecting patient health and safety during the public health emergency (PHE).

181

HHS

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Waiver

Onsite Visits for Hospice Aide Supervision

Waiving the requirements at 42 CFR § 418.76(h), which require a nurse to conduct an onsite supervisory visit every two weeks. This would include waiving the requirements for a nurse or other professional to conduct an onsite visit every two weeks to evaluate if aides are providing care consistent with the care plan, as this may not be physically possible for a period of time.

182

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Waiver

Patient Self Determination Act Requirements (Advance Directives)

Waiving the requirements at sections 1902(a)(58) and 1902(w)(1)(A) of the Act (for Medicaid); 1852(i) of the Act (for Medicare Advantage); and 1866(f) of the Act and 42 CFR § 489.102 (for Medicare), which require hospitals and CAHs to provide information about their advance directive policies to patients. CMS is waiving this requirement to allow staff to more efficiently deliver care to a larger number of patients.

183

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Waiver

Resident Roommates and Grouping

Waiving the requirements in 42 CFR 483.10(e) (5), (6), and (7) solely for the purposes of grouping or cohorting residents with respiratory illness symptoms and/or residents with a confirmed diagnosis of COVID-19, and separating them from residents who are asymptomatic or tested negative for COVID-19. This action waives a facility's requirements, under 42 CFR 483.10, to provide for a resident to share a room with his or her roommate of choice in certain circumstances, to provide notice and rationale for changing a resident's room, and to provide for a resident's refusal a transfer to another room in the facility. This aligns with CDC guidance to preferably place residents in locations designed to care for COVID-19 residents, to prevent the transmission of COVID-19 to other residents.

184

HHS

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Waiver

Defer Equipment Maintenance & Fire Safety Inspections

Waiving the requirement at 42 CFR § 494.60(b) for on-time preventive maintenance of dialysis machines and ancillary dialysis equipment. Additionally, CMS is also waiving the requirements under § 494.60(d) which requires ESRD facilities to conduct on-time fire inspections. These waivers are intended to ensure that dialysis facilities are able to focus on the operations related to the Public Health Emergency.

185

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Waiver

Ability to Delay Some Patient Assessments

CMS is not waiving subsections (a) or (c) of 42 CFR § 494.80, but is waiving the following requirements at 42 CFR § 494.80(b) related to the frequency of assessments for patients admitted to the dialysis facility. CMS is waiving the “on time” requirements for the initial and follow up comprehensive assessments within the specified timeframes as noted below. This waiver applies to assessments conducted by members of the interdisciplinary team, including: A registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. These waivers are intended to ensure that dialysis facilities are able to focus on the operations related to the Public Health Emergency. Specifically, CMS is waiving:

• § 494.80(b)(1): An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.

• § 494.80(b)(2): A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient's plan of care specified in § 494.90.

186

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Waiver

SNF-Waiving Pre-Admission Screening and Annual Resident Review (PASARR)

Waiving 42 CFR 483.20(k), allowing nursing homes to admit new residents who have not received Level 1 or Level 2 Preadmission Screening. Level 1 assessments may be performed post-admission. On or before the 30th day of admission, new patients admitted to nursing homes with a mental illness (MI) or intellectual disability (ID) should be referred promptly by the nursing home to State PASARR program for Level 2 Resident Review.

187

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Waiver

Physician Self-Referral Regulations

Waivers of Sanctions under the Stark Law. CMS will permit certain referrals and the submission of related claims that would otherwise violate the Stark Law. These flexibilities include: (1) Hospitals and other health care providers can pay above or below fair market value for the personal services of a physician (or an immediate family member of a physician), and parties may pay below fair market value to rent equipment or purchase items or services. (2) Health care providers can support each other financially to ensure continuity of health care operations. (3) Hospitals can provide benefits to their medical staffs, such as multiple daily meals, laundry service to launder soiled personal clothing, or child care services while the physicians are at the hospital and engaging in activities that benefit the hospital and its patients. (4) Health care providers may offer certain items and services that are solely related to COVID-19 Purposes (as defined in the waivers), even when the provision of the items or services would exceed the annual non-monetary compensation cap; (5) Physician-owned hospitals can temporarily increase the number of their licensed beds, operating rooms, and procedure rooms, even though such expansion would otherwise be prohibited under the Stark Law; (6) Some of the restrictions when a group practice can furnish medically necessary designated health services (DHS) in a patient's home are loosened. (7) Group practices can furnish medically necessary MRIs, CT scans or clinical laboratory services from locations like mobile vans in parking lots that the group practice rents on a part-time basis.

188

HHS

CMS

Waiver

Medicare Graduate Medical Education (GME) Affiliation Agreement

Due to the COVID-19 Public Health Emergency (PHE), under the authority of section 1135(b)(5) of the Social Security Act (the Act), CMS is waiving the July 1 submission deadline under 42 CFR 413.79(f)(1) for new Medicare GME affiliation agreements and the June 30 deadline under the May 12, 1998 Health Care Financing Administration Final Rule (63 FR 26318, 26339, 26341) for amendments of existing Medicare GME affiliation agreements. That is, during the COVID-19 PHE, instead of requiring that new Medicare GME affiliation agreements be submitted to CMS and the MACs by July 1, 2020 (for the academic year starting July 1, 2020), and that amendments to Medicare GME affiliation agreements be submitted to CMS and the MACS by June 30, 2020 (for academic year ending June 30, 2020), CMS is allowing hospitals to submit new and/or amended Medicare GME affiliation agreements as applicable to CMS and the MACs by October 1, 2020. As under existing procedures, hospitals should email new and/or amended agreements to CMS at

Medicare_GME_Affiliation_Agreement@cms.hhs.gov,

and indicate in the subject line whether the affiliation agreement is a new one or an amended one.

189

HHS

CMS

Waiver

Allow use of audio-only equipment to furnish audio-only telephone E/M, counseling, and educational services

Pursuant to authority granted under the CARES Act, CMS is waiving the requirements of section 1834(m)(1) of the ACT and 42 CFR § 410.78(a)(3) for use of interactive telecommunications systems to furnish telehealth services, to the extent they require use of video technology, for certain services. This waiver allows the use of audio-only equipment to furnish services described by the codes for audio-only telephone evaluation and management services, and behavioral health counseling and educational services (see designated codes

https://www.cms.gov/Medicare/MedicareGeneral-Information/Telehealth/Telehealth-Codes

). Unless provided otherwise, other services included on the Medicare telehealth services list must be furnished using, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

190

HHS

CMS

Waiver

Hospital Telemedicine

Waiving the provisions related to telemedicine at 42 CFR § 482.12(a)(8)-(9) for hospitals and § 485.616(c) for CAHs, making it easier for telemedicine services to be furnished to the hospital's patients through an agreement with an off-site hospital.

191

HHS

CMS

Waiver

Hospital Care of Patients

Waiving requirements under 42 CFR § 482.12(c)(1)-(2) and § 482.12(c)(4), which requires that Medicare patients be under the care of a physician. This waiver may be implemented so long as it is not inconsistent with a state's emergency preparedness or pandemic plan. This allows hospitals to use other practitioners to the fullest extent possible.

192

HHS

CMS

Waiver

Responsibilities of Physicians in Critical Access Hospitals (CAHs)

42 CFR § 485.631(b)(2). CMS is waiving the requirement for CAHs that a doctor of medicine or osteopathy be physically present to provide medical direction, consultation, and supervision for the services provided in the CAH at § 485.631(b)(2). CMS is retaining the regulatory language in the second part of the requirement at § 485.631(b)(2) that a physician be available “through direct radio or telephone communication, or electronic communication for consultation, assistance with medical emergencies, or patient referral.” Retaining this longstanding CMS policy and related longstanding subregulatory guidance that further described communication between CAHs and physicians will assure an appropriate level of physician direction and supervision for the services provided by the CAH. This will allow the physician to perform responsibilities remotely, as appropriate. This also allows CAHs to use nurse practitioners and physician assistants to the fullest extent possible, while ensuring necessary consultation and support as needed.

193

HHS

CMS

Waiver

Anesthesia Services

Waiving requirements under 42 CFR § 482.52(a)(5), § 485.639(c)(2), and § 416.42 (b)(2) that a certified registered nurse anesthetist (CRNA) is under the supervision of a physician in paragraphs § 482.52(a)(5) and § 485.639(c)(2). CRNA supervision will be at the discretion of the hospital and state law. This waiver applies to hospitals, CAHs, and Ambulatory Surgical Centers (ASCs). These waivers will allow CRNAs to function to the fullest extent of their licensure, and may be implemented so long as they are not inconsistent with a state's emergency preparedness or pandemic plan.

194

HHS

CMS

Waiver

Physician Supervision of NPs in RHCs and FQHCs

42 CFR 491.8(b)(1). We are modifying the requirement that physicians must provide medical direction for the clinic's or center's health care activities and consultation for, and medical supervision of, the health care staff, only with respect to medical supervision of nurse practitioners, and only to the extent permitted by state law. The physician, either in person or through telehealth and other remote communications, continues to be responsible for providing medical direction for the clinic or center's health care activities and consultation for the health care staff, and medical supervision of the remaining health care staff

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