Roger T. Severino, Director, Office for Civil Rights, HHS, Enforcement Discretion Under HIPAA To Allow Uses and Disclosures of Protected Health Information by Business Associates for Public Health and Health Oversight Activities in Response to COVID-19, 85 Fed. Reg. 19392 (Apr. 7, 2020) (Apr. 2, 2020) (Ex. AGY-FED-HEALTH-OTHER-002)
Drug Enforcement Administration, Diversion Control Division (guidance document EO-DEA213), DEA-DC-043 (EO-DEA213), guidance: Administering certain controlled substances in the parking lot of a health care provider's DEA-registered location during the COVID-19 public health emergency (July 28, 2020) (Ex. AGY-FED-HEALTH-OTHER-021)
Roger T. Severino, Director, Office for Civil Rights, HHS, Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency, 85 Fed. Reg. 22024 (Apr. 21, 2020) (Mar. 17, 2020) (Ex. AGY-FED-HEALTH-OTHER-001)
HHS Office for Civil Rights, Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (Mar. 17, 2020) (Ex. FED-194)
Food and Drug Administration, CDRH, Guidance for Industry and FDA Staff: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (March 2020) (Mar. 22, 2020) (Ex. AGY-FED-HEALTH-OTHER-043)
Roger T. Severino, Director, Office for Civil Rights, HHS, Enforcement Discretion Regarding COVID-19 Community-Based Testing Sites (CBTS) During the COVID-19 Nationwide Public Health Emergency, 85 Fed. Reg. 29637 (May 18, 2020) (Apr. 9, 2020) (Ex. AGY-FED-HEALTH-OTHER-003)
Melanie Fontes Rainer, Director, Office for Civil Rights, HHS, Notice of Expiration of Certain Notifications of Enforcement Discretion Issued in Response to the COVID-19 Nationwide Public Health Emergency, 88 Fed. Reg. 22380 (Apr. 13, 2023) (Apr. 11, 2023) (Ex. AGY-FED-HEALTH-OTHER-006)
Department of Veterans Affairs (Robert L. Wilkie, Secretary), Interim Final Rule, Authority of VA Professionals To Practice Health Care, 85 Fed. Reg. 71838 (Nov. 12, 2020) (Ex. AGY-FED-HEALTH-OTHER-061)
Robinsue Frohboese, Acting Director, Office for Civil Rights, HHS, Enforcement Discretion Regarding Online or Web-Based Scheduling Applications for the Scheduling of Individual Appointments for COVID-19 Vaccination During the COVID-19 Nationwide Public Health Emergency, 86 Fed. Reg. 11076 (Feb. 24, 2021) (Jan. 19, 2021) (Ex. AGY-FED-HEALTH-OTHER-005)
Drug Enforcement Administration, Diversion Control Division, DEA-DC-023 (DEA075), How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency (decision tree) (Mar. 31, 2020) (Ex. AGY-FED-HEALTH-OTHER-015)
SAMHSA, COVID-19 Public Health Emergency Response and 42 CFR Part 2 Guidance (Mar. 19, 2020) (Ex. AGY-FED-HEALTH-OTHER-027)
Centers for Medicare & Medicaid Services, HHS, CMS-5531-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (interim final rule) (May 1, 2020) (Ex. FED-091)
Centers for Medicare & Medicaid Services, HHS (with Treasury and Labor), CMS-9912-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (interim final rule): 42 C.F.R. § 433.400 (FMAP maintenance-of-effort conditions); vaccine coverage (Nov. 2, 2020) (Ex. FED-093)
Denis McDonough, Secretary of Veterans Affairs, VA announcement of July 26, 2021: COVID-19 vaccination mandatory for Title 38 VHA health care personnel within eight weeks (Ex. AGY-FED-HEALTH-OTHER-069)
Indian Health Service (Principal Deputy Director Rear Adm. Michael D. Weahkee), IHS Coronavirus (COVID-19) News page listing the Tribal and Urban Indian Organization Leader letters of Mar. 9, 16, 23 and 27, 2020 (archived Mar. 29, 2020) (Ex. AGY-FED-HEALTH-OTHER-058)
Denis McDonough, Secretary of Veterans Affairs, VA announcement of Aug. 12, 2021: vaccine mandate expanded effective Aug. 13, 2021 to most VHA employees and to volunteers and contractors who work in or visit VHA facilities or come into contact with VA patients and health care workers (Ex. AGY-FED-HEALTH-OTHER-070)
Secretary of Health and Human Services (terms administered by HRSA), Provider Relief Fund, Acceptance of Terms and Conditions, Relief Fund Payment from Initial $30 Billion General Distribution (Apr. 10, 2020) (Ex. AGY-FED-HEALTH-OTHER-118)
Centers for Medicare & Medicaid Services, HHS, CMS-1744-IFC, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (interim final rule with comment period) (Mar. 30, 2020) (Ex. FED-090)
Secretary of Health and Human Services, Determination of Public Health Emergency and Declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for 2019-nCoV (Feb. 4, 2020) (Ex. FED-181)
OSHA Parsippany Area Office; DOL Office of Public Affairs, OSHA citations of Hackensack Meridian Health Residential Care Inc., North Bergen, New Jersey (two serious, one other-than-serious; proposed penalty $28,070), announced Sept. 11, 2020 (Ex. AGY-FED-LABOR-IMMIGRATION-032)
Centers for Medicare & Medicaid Services, HHS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (consolidated document; version updated May 24, 2021) (Mar. 13, 2020) (Ex. FED-160)
Centers for Medicare & Medicaid Services, HHS, CMS-3415-IFC, Omnibus COVID-19 Health Care Staff Vaccination, 86 Fed. Reg. 61555 (Nov. 5, 2021) (Nov. 4, 2021) (Ex. FED-095)
Under Secretary of Defense for Personnel and Readiness (Matthew P. Donovan), Force Health Protection Guidance for the Novel Coronavirus Outbreak (Jan. 30, 2020) (Ex. AGY-DEFENSE-GUARD-026)
Under Secretary of Defense for Personnel and Readiness (Gilbert R. Cisneros, Jr. designate; signed by the Acting USD), Force Health Protection Guidance (Supplement 17) Revision 1, DoD Guidance for the Use of Masks, Personal Protective Equipment, and Non-Pharmaceutical Interventions During the COVID-19 Pandemic (June 22, 2021; posted June 23) (Ex. AGY-DEFENSE-GUARD-077)
Under Secretary of Defense for Personnel and Readiness, Force Health Protection Guidance (Supplement 22), DoD Guidance for Coronavirus Disease 2019 Surveillance and Screening Testing (July 28, 2021) (Ex. AGY-DEFENSE-GUARD-080)
Food and Drug Administration, HHS, Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under CLIA Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency; Immediately in Effect Guidance, 85 Fed. Reg. 13138 (Mar. 6, 2020) (Feb. 29, 2020) (Ex. AGY-FED-HEALTH-OTHER-032)
Centers for Medicare & Medicaid Services (HHS), CMS-3415-IFC, Omnibus COVID-19 Health Care Staff Vaccination, 86 Fed. Reg. 61555 (Nov. 5, 2021) (Nov. 4, 2021) (Ex. ECO-B-010)
CMS, Quality, Safety & Oversight Group, QSO-20-18-HHA, Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs) (Mar. 10, 2020) (Ex. FED-098)
Centers for Medicare & Medicaid Services (section 1135 waiver authority), COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (LTC facilities, HHAs, hospices, ICF/IIDs) (Mar. 30, 2020) (Ex. SEC-04-015)
Jacqueline A. O'Shaughnessy, Acting Chief Scientist, FDA (letter to CDC), Emergency Use Authorization: NIOSH-approved air purifying respirators for health care personnel (issued Mar. 2, 2020; reissued Mar. 28, 2020 and July 12, 2021) (Ex. AGY-FED-HEALTH-OTHER-052)
Under Secretary of Defense for Personnel and Readiness, Force Health Protection Guidance (Supplement 11), DoD Guidance for Coronavirus Disease 2019 Surveillance and Screening with Testing (June 11, 2020) (Ex. AGY-DEFENSE-GUARD-049)
Superintendent Cassius Cash, News release, 'Park Modifies Operations to Implement Latest Health Guidance' (campgrounds, pavilions, church and special-use permits) (Mar. 18, 2020) (Ex. AGY-FED-LANDS-SCIENCE-COURTS-049)
OSHA, Avenel Area Office (Inspection No. 1480762), Citation, Hackensack Meridian Health Jersey Shore University Medical Center, Neptune, NJ (respiratory protection; recordkeeping) (Dec. 8, 2020) (Ex. DUT-FED-021)
CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (hospitals: Hospitals Without Walls; EMTALA; verbal orders; discharge planning; medical staff; physical environment; surge sites) (Mar. 30, 2020) (Ex. SEC-01-010)
Alex M. Azar II, Secretary of Health and Human Services, Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020) (Mar. 10, 2020) (Ex. AGY-FED-HEALTH-OTHER-040)
SAMHSA, Center for Substance Abuse Treatment, Division of Pharmacologic Therapies, FAQs: Provision of methadone and buprenorphine for the treatment of Opioid Use Disorder in the COVID-19 emergency (Apr. 21, 2020) (Ex. AGY-FED-HEALTH-OTHER-025)
Centers for Medicare & Medicaid Services, CMS-5531-IFC, 85 Fed. Reg. 27550 (May 8, 2020) (Ex. SEC-04-006)
SAMHSA (Assistant Secretary for Mental Health and Substance Use), Opioid Treatment Program (OTP) Guidance (Mar. 16, 2020; updated Mar. 19, 2020): blanket take-home exceptions (Ex. AGY-FED-HEALTH-OTHER-026)
Food and Drug Administration, HHS, Notice, Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 85 Fed. Reg. 27987 (May 12, 2020) (Ex. AGY-FED-HEALTH-OTHER-033)
Departments of Labor, Health and Human Services and the Treasury, FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 42 (Apr. 11, 2020) (Ex. SEC-13-023)
SAMHSA, Methadone Take-Home Flexibilities Extension Guidance (Nov. 18, 2021) (Ex. AGY-FED-HEALTH-OTHER-029)
SAMHSA, HHS, Final Rule, Medications for the Treatment of Opioid Use Disorder, 89 Fed. Reg. 7528 (Feb. 2, 2024) (Ex. AGY-FED-HEALTH-OTHER-030)
Department of Veterans Affairs, VA announcement of Mar. 27, 2020 releasing the VHA COVID-19 Response Plan: elective and non-emergent procedures postponed; outpatient care shifted to telehealth (Ex. AGY-FED-HEALTH-OTHER-066)
CMS (Secretary of HHS), COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (Mar. 30, 2020) (Ex. SEC-02-005)
CMS, CMS-1744-IFC, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, 85 Fed. Reg. 19230 (Apr. 6, 2020) (Ex. SEC-02-006)
CMS, CMS-5531-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, 85 Fed. Reg. 27550 (May 8, 2020) (Ex. SEC-02-007)
Centers for Medicare & Medicaid Services, Department of Health and Human Services, CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020) (Ex. SEC-04-004)
Assistant Secretary of Defense for Health Affairs (Thomas McCaffery), Memorandum, Elective Surgical, Invasive, and Dental Procedures in Military Treatment Facilities (Mar. 24, 2020) (Ex. AGY-DEFENSE-GUARD-027)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA, DEA-DC-018 (DEA067), Dear Registrant letter granting an exception to separate State registration for practitioners dispensing in additional States during the COVID-19 emergency (Mar. 25, 2020) (Ex. AGY-FED-HEALTH-OTHER-011)
Drug Enforcement Administration, Department of Justice; Substance Abuse and Mental Health Services Administration, HHS, Temporary Rule, Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 Fed. Reg. 30037 (May 10, 2023) (Ex. AGY-FED-HEALTH-OTHER-024)
SAMHSA, Division of Pharmacologic Therapies, Center for Substance Abuse Treatment, OTP Guidance for Patients Quarantined at Home with the Coronavirus (doorstep delivery protocol) (updated Mar. 30, 2020) (Ex. AGY-FED-HEALTH-OTHER-028)
Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Face Shields (umbrella) (issued Apr. 9, 2020; amended Apr. 13, 2020) (Ex. AGY-FED-HEALTH-OTHER-053)
Department of Veterans Affairs (Secretary Robert Wilkie), VA announcement of Mar. 10, 2020: 'No Visitor' stance and suspension of new admissions at all VA nursing homes (community living centers) and spinal cord injury and disorder centers (Ex. AGY-FED-HEALTH-OTHER-064)
Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (issued Mar. 24, 2020; reissued Mar. 28, 2020, May 7, 2020 and Mar. 24, 2021; revoked July 6, 2021) (Ex. AGY-FED-HEALTH-OTHER-049)
Director, Defense Health Agency, DHA-IPM, Department of Defense COVID-19 Vaccination Program Implementation (Dec. 13, 2020) (Ex. AGY-DEFENSE-GUARD-031)
Director, Defense Health Agency, DHA-IPM 20-004 (rev.), DoD COVID-19 Vaccination Program Implementation (Dec. 31, 2020) (Ex. AGY-DEFENSE-GUARD-033)
Assistant Secretary of Defense for Health Affairs, Memorandum, Resuming Elective Surgical, Invasive, and Dental Procedures in Military Medical and Dental Treatment Facilities (May 21, 2020) (Ex. AGY-DEFENSE-GUARD-045)
Drug Enforcement Administration, Diversion Control Division, DEA-DC-021 (DEA073), letter to practitioner registrants and pharmacists announcing temporary exceptions for oral schedule II prescriptions in emergency situations during the COVID-19 emergency (Mar. 27, 2020) (Ex. AGY-FED-HEALTH-OTHER-013)
Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Gowns and Other Apparel (umbrella) (May 22, 2020) (Ex. AGY-FED-HEALTH-OTHER-054)
Centers for Medicare & Medicaid Services, HHS, CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020) (42 C.F.R. 483.80(h) testing; 482.42(e) hospital reporting) and QSO-20-38-NH (Aug. 26, 2020; revised through Sept. 23, 2022) (Ex. FED-092)
Occupational Safety and Health Administration, U.S. Department of Labor, COVID-19 Healthcare Emergency Temporary Standard, 29 C.F.R. 1910.502 (with 1910.504, 1910.505, 1910.509) (June 21, 2021) (Ex. SEC-02-001)
Centers for Medicare & Medicaid Services, CMS-1744-IFC, 85 Fed. Reg. 19230 (Apr. 6, 2020) (Ex. SEC-04-017)
Department of Labor, Occupational Safety and Health Administration, COVID-19 Healthcare Emergency Temporary Standard, 29 C.F.R. 1910.502,.504,.505,.509 (June 21, 2021) (Ex. SEC-19-009)
Drug Enforcement Administration, Diversion Control Division (with the HHS Secretary's designation of Mar. 16, 2020), DEA-DC-016, COVID-19 Information Page: Telemedicine (designation that the section 802(54)(D) telemedicine allowance applies to all schedule II-V controlled substances in all areas of the United States) (Mar. 16, 2020) (Ex. AGY-FED-HEALTH-OTHER-009)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA, DEA-DC-022 (DEA068), letter permitting DATA-waived practitioners to prescribe buprenorphine to new patients on the basis of a telephone evaluation during the COVID-19 emergency (Mar. 31, 2020) (Ex. AGY-FED-HEALTH-OTHER-014)
Food and Drug Administration, HHS, Notice, Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 86 Fed. Reg. 48712 (Aug. 31, 2021) (Ex. AGY-FED-HEALTH-OTHER-048)
Office of the Secretary of Defense (Assistant Secretary of Defense for Health Affairs), TRICARE Coverage of Certain Medical Benefits in Response to the COVID-19 Pandemic, interim final rule, 85 Fed. Reg. 54914 (Sept. 3, 2020) (Ex. AGY-DEFENSE-GUARD-073)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA (letter to Assistant Secretary Elinore McCance-Katz, SAMHSA), DEA-DC-015, Exception to 21 C.F.R. 1301.74(h) for Narcotic Treatment Programs (take-home delivery by NTP staff, law enforcement or National Guard) (Mar. 16, 2020) (Ex. AGY-FED-HEALTH-OTHER-008)
Drug Enforcement Administration, Diversion Control Division (guidance document EO-DEA192), DEA-DC-044 (EO-DEA192), guidance: Telemedicine and separate State registration (July 28, 2020) (Ex. AGY-FED-HEALTH-OTHER-022)
Food and Drug Administration, HHS, Notice, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 85 Fed. Reg. 34638 (June 5, 2020) (Ex. AGY-FED-HEALTH-OTHER-034)
Denise M. Hinton, Chief Scientist, FDA (letter to Battelle Memorial Institute), Emergency Use Authorization: Battelle Critical Care Decontamination System for decontaminating compatible N95 respirators (issued Mar. 28, 2020; reissued Jan. 21, 2021; revoked June 30, 2021) (Ex. AGY-FED-HEALTH-OTHER-050)
Food and Drug Administration (Office of the Chief Scientist), Emergency Use Authorization: Surgical Masks (umbrella) (issued Aug. 5, 2020; reissued Mar. 6, 2023) (Ex. AGY-FED-HEALTH-OTHER-055)
Occupational Safety and Health Administration, national news release, News release, U.S. Department of Labor's OSHA Announces $3,930,381 In Coronavirus Violations (Jan. 8, 2021) (Ex. DUT-FED-067)
Occupational Safety and Health Administration, U.S. Department of Labor, Occupational Exposure to COVID-19; Emergency Temporary Standard, 29 C.F.R. 1910.502, 86 Fed. Reg. 32376 (June 21, 2021) (Ex. FED-080)
CMS, Survey and Certification Group, CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020) (42 C.F.R. 483.80(h) testing; 482.42(e) hospital reporting) and QSO-20-38-NH (Aug. 26, 2020; revised through Sept. 23, 2022) (Ex. FED-153)
Secretary of Health and Human Services, Emergency Use Authorization Declaration: drugs and biological products (Mar. 27, 2020) (Ex. FED-184)
Centers for Medicare & Medicaid Services, HHS, CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020): 42 C.F.R. 482.42(e) and 485.640(d) (hospital and CAH COVID-19 reporting as a condition of participation); 483.80(h) (LTC testing); 493.41 (laboratory SARS-CoV-2 test reporting) (Aug. 25, 2020) (Ex. SEC-01-004)
Centers for Medicare & Medicaid Services, CMS-3415-IFC, 86 Fed. Reg. 61555 (Nov. 5, 2021) (Ex. SEC-04-021)
Departments of Labor, Health and Human Services and the Treasury, FAQs About FFCRA and CARES Act Implementation Part 44 (Feb. 26, 2021) (Ex. SEC-13-024)
Occupational Safety and Health Administration, 29 C.F.R. 1910.134 (respiratory protection) (standing) (Ex. DUT-FED-004)
Secretary of Health and Human Services (Acting Secretary Norris Cochran), Seventh Amendment to the PREP Act Declaration, 86 Fed. Reg. 14462 (Mar. 16, 2021) (Mar. 11, 2021) (Ex. SEC-26-003)
U.S. Department of Transportation, Office of Drug and Alcohol Policy and Compliance (ODAPC), DOT COVID-19 Drug & Alcohol Testing Statement of Enforcement Discretion for Substance Abuse Professionals and Service Agents (Apr. 4, 2020) (Ex. AGY-AVIATION-SURFACE-045)
Drug Enforcement Administration (D. Christopher Evans, Acting Administrator), Final Rule, Registration Requirements for Narcotic Treatment Programs With Mobile Components, 86 Fed. Reg. 33861 (June 28, 2021) (Ex. AGY-FED-HEALTH-OTHER-007)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA, DEA-DC-017 (DEA065), Dear Registrant letter on early refills and 90-day supplies of controlled substances during the COVID-19 emergency (Mar. 20, 2020) (Ex. AGY-FED-HEALTH-OTHER-010)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA, DEA-DC-025 (DEA078), Dear Registrant letter permitting opioid treatment programs to use the same off-site location repeatedly to deliver take-home methadone doses without separate registration (Apr. 7, 2020) (Ex. AGY-FED-HEALTH-OTHER-016)
William T. McDermott, Assistant Administrator, Diversion Control Division, DEA, DEA-DC-028 (DEA084), letter permitting DEA-registered hospitals and clinics to handle controlled substances at satellite locations under the existing registration during the COVID-19 emergency (Apr. 10, 2020) (Ex. AGY-FED-HEALTH-OTHER-018)
William T. McDermott, Assistant Administrator, Diversion Control Division, DEA, DEA-DC-029 (DEA085), letter granting a temporary exception to the five percent rule for practitioners distributing controlled substances to other registrants during the COVID-19 emergency (Apr. 13, 2020) (Ex. AGY-FED-HEALTH-OTHER-019)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA, DEA-DC-030 (DEA087), letter extending the off-site take-home delivery flexibility to buprenorphine dispensed by opioid treatment programs (Apr. 21, 2020) (Ex. AGY-FED-HEALTH-OTHER-020)
Drug Enforcement Administration, Diversion Control Division (guidance document EO-DEA183), DEA-DC-052 (EO-DEA183), guidance: Using a home address as the principal place of business or professional practice (July 8, 2021) (Ex. AGY-FED-HEALTH-OTHER-023)
Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories (Mar. 24, 2020) (Ex. AGY-FED-HEALTH-OTHER-051)
Department of Veterans Affairs, Interim Final Rule, Home Visits in Program of Comprehensive Assistance for Family Caregivers During COVID-19 National Emergency, 85 Fed. Reg. 34523 (June 5, 2020) (Ex. AGY-FED-HEALTH-OTHER-062)
Department of Veterans Affairs, Interim Final Rule, Informed Consent and Advance Directives, 85 Fed. Reg. 31698 (May 27, 2020) (Ex. AGY-FED-HEALTH-OTHER-063)
Department of Veterans Affairs, National Cemetery Administration, VA announcement of Mar. 20, 2020: committal services and military funeral honors discontinued at all national cemeteries effective Mar. 23, 2020; witnesses limited to immediate family of no more than ten (Ex. AGY-FED-HEALTH-OTHER-065)
Assistant Secretary of Labor for Occupational Safety and Health, OSHA Direction DIR 2021-02 (CPL 02), Inspection Procedures for the COVID-19 Emergency Temporary Standard, June 28, 2021 (Ex. AGY-FED-LABOR-IMMIGRATION-027)
Assistant Secretary of Labor for Occupational Safety and Health, OSHA Direction DIR 2021-01 (CPL 03), National Emphasis Program - Coronavirus Disease 2019 (COVID-19), effective Mar. 12, 2021 (full directive text) (Ex. AGY-FED-LABOR-IMMIGRATION-087)
Occupational Safety and Health Administration (DOL), Occupational Exposure to COVID-19; Emergency Temporary Standard, 86 Fed. Reg. 32376 (June 21, 2021) (Ex. ECO-B-012)
Secretary of Health and Human Services, Declaration Under the PREP Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020; effective Feb. 4, 2020) (Mar. 10, 2020) (Ex. FED-180)
Occupational Safety and Health Administration, COVID-19 Healthcare ETS Frequently Asked Questions (dental questions) (June 10, 2021) (Ex. SEC-03-005)
Occupational Safety and Health Administration, Department of Labor, 29 C.F.R. 1910.502, 86 Fed. Reg. 32376 (COVID-19 Healthcare Emergency Temporary Standard) (June 21, 2021) (Ex. SEC-04-014)
Centers for Disease Control and Prevention, Department of Health and Human Services, No Sail Order and Suspension of Further Embarkation (Mar. 14, 2020), published 85 Fed. Reg. 16628 (Mar. 24, 2020) (Ex. SEC-06-001)
Office of the Secretary of Defense (Assistant Secretary of Defense for Health Affairs), TRICARE Coverage and Payment for Certain Services in Response to the COVID-19 Pandemic, interim final rule, 85 Fed. Reg. 27921 (May 12, 2020) (Ex. AGY-DEFENSE-GUARD-072)
Deputy Secretary of Defense David L. Norquist, Memorandum, Coronavirus Disease 2019 Vaccine Guidance (Dec. 7, 2020) (Ex. AGY-DEFENSE-GUARD-113)
Occupational Safety and Health Administration, 29 C.F.R. 1910.1030 (bloodborne pathogens) (standing) (Ex. DUT-FED-007)
U.S. Department of Transportation, Office of Drug and Alcohol Policy and Compliance, DOT COVID-19 Drug & Alcohol Testing Statement of Enforcement Discretion for Substance Abuse Professionals and Service Agents (Apr. 4, 2020; updated June 17, 2020; Sept. 22, 2020; Dec. 9, 2020; and May 27, 2021) (Ex. AGY-AVIATION-SURFACE-046)
OSHA, Directorate of Enforcement Programs (Patrick J. Kapust, Acting Director), to Regional Administrators and State Plan Designees, Memorandum, Temporary Enforcement Guidance - Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces During the COVID-19 Outbreak (Mar. 14, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-015)
Assistant Secretary of Labor for Occupational Safety and Health (James Frederick, Acting), OSHA Direction DIR 2021-01 (CPL 03), National Emphasis Program - Coronavirus Disease 2019 (COVID-19) (record page), effective Mar. 12, 2021 (Ex. AGY-FED-LABOR-IMMIGRATION-026)
Assistant Secretary of Labor for Occupational Safety and Health, OSHA Direction DIR 2021-03 (CPL 03), Revised National Emphasis Program - Coronavirus Disease 2019 (COVID-19) (record page), effective July 7, 2021 (Ex. AGY-FED-LABOR-IMMIGRATION-028)
Assistant Secretary of Labor for Occupational Safety and Health, OSHA Direction DIR 2021-03 (CPL 03), Revised National Emphasis Program - Coronavirus Disease 2019 (COVID-19), effective July 7, 2021 (full directive text) (Ex. AGY-FED-LABOR-IMMIGRATION-088)
Occupational Safety and Health Administration, Common COVID-19 Citations: Helping Employers Better Protect Workers and Comply with OSHA Regulations (Nov. 2020) (standing) (Ex. DUT-FED-020)
Department of Veterans Affairs (Secretary Denis McDonough), VA press release, 'VA mandates COVID-19 vaccines among its medical employees' (July 26, 2021) (Ex. ECO-B-089)
OSHA, Directorate of Enforcement Programs, DIR 2021-03 (CPL 03), Revised National Emphasis Program - COVID-19 (July 7, 2021) (Ex. FED-083)
Occupational Safety and Health Administration, U.S. Department of Labor, Occupational Exposure to COVID-19; Emergency Temporary Standard (Healthcare), 29 C.F.R. part 1910, subpart U, 1910.502-1910.509 (June 21, 2021) (Ex. SEC-01-001)
CDC, HHS, No Sail Order and Other Measures Related to Operations; Modification and Extension (signed Apr. 9, 2020), 85 Fed. Reg. 21004 (Apr. 15, 2020) (Ex. SEC-06-002)
CDC, HHS, No Sail Order; Third Modification and Extension (Sept. 30, 2020), 85 Fed. Reg. 62732 (Oct. 5, 2020) (Ex. SEC-06-004)
Occupational Safety and Health Administration, OSHA COVID-19 Healthcare Emergency Temporary Standard - Frequently Asked Questions (agency interpretation of the scope provisions, § 1910.502(a)) (June 21, 2021) (Ex. SEC-18-004)
CMS, Quality, Safety & Oversight Group, CMS QSO-20-12-All (Mar. 4, 2020), QSO-20-20-All (Mar. 23, 2020), QSO-20-31-All (June 1, 2020), QSO-20-35-ALL (Aug. 17, 2020) (Ex. FED-164)
OSHA Directorate of Enforcement Programs to Regional Administrators and State Plan Designees, Memorandum, Enforcement Guidance for Respiratory Protection and the N95 Shortage Due to the Coronavirus Disease 2019 (COVID-19) Pandemic (Apr. 3, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-016)
OSHA Directorate of Enforcement Programs, Memorandum, Enforcement Guidance on Decontamination of Filtering Facepiece Respirators in Healthcare During the COVID-19 Pandemic (Apr. 24, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-022)
OSHA Directorate of Enforcement Programs to Regional Administrators and State Plan Designees, Memorandum, Updated Interim Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19) (May 19, 2020; effective May 26, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-024)
OSHA Directorate of Enforcement Programs (Patrick J. Kapust, Acting Director) to Regional Administrators and State Plan Designees, Memorandum, Updated Interim Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19) (Mar. 12, 2021) (Ex. AGY-FED-LABOR-IMMIGRATION-025)
Commandant, U.S. Coast Guard, Waterways Policies and Activities Division (CG-WWM-1), MSIB 17-20 (June 3, 2020) (Ex. AGY-USCG-PORTS-023)
CMS, Quality, Safety & Oversight Group, CMS QSO-20-12-All (Mar. 4, 2020), QSO-20-20-All (Mar. 23, 2020), QSO-20-31-All (June 1, 2020), QSO-20-35-ALL (Aug. 17, 2020) (Ex. FED-099)
Federal Aviation Administration, Office of the Chief Counsel (Enforcement Division), Notice of enforcement policy, 85 Fed. Reg. 18110 (Apr. 1, 2020) (Ex. AGY-AVIATION-SURFACE-012)
Commanding General, 101st Airborne Division (Air Assault) and Fort Campbell, General Order - Fort Campbell Mask Policy (May 2021) (May 14, 2021) (Ex. AGY-DEFENSE-GUARD-071)
U.S. Army Corps of Engineers with HHS, USACE Alternate Care Sites (ACS) program page and implementation materials (as archived Mar. 27, 2020) (Ex. AGY-DEFENSE-GUARD-101)
U.S. Northern Command (DoD News), Army Transforms Event Center Into Hospital for COVID-19 Response (Mar. 30, 2020) (Ex. AGY-DEFENSE-GUARD-102)
96th Test Wing, Eglin AFB (published on eglin.af.mil), COVID-19: Service reductions, closures, cancellations, updates (running notice, published Apr. 16, 2020; first posted Mar. 20, 2020) (Ex. AGY-DEFENSE-GUARD-103)
National Archives and Records Administration (Archivist David S. Ferriero), Press release nr20-47, 'National Archives Research Rooms and Presidential Libraries Nationwide to Close March 14' (Mar. 13, 2020) (Ex. AGY-FED-LANDS-SCIENCE-COURTS-090)
Centers for Disease Control and Prevention, No Sail Order and Suspension of Further Embarkation; Third Modification and Extension, 85 Fed. Reg. 62732 (Sept. 30, 2020) (Ex. ECO-C-139)
Centers for Disease Control and Prevention, Temporary Extension and Modification of Framework for Conditional Sailing Order (CSO) for Cruise Ships Operating or Intending To Operate in U.S. Waters, 86 Fed. Reg. 59720 (Oct. 28, 2021) (Oct. 25, 2021) (Ex. ECO-C-141)
OSHA, Directorate of Enforcement Programs, DIR 2021-02 (CPL 02), Inspection Procedures for the COVID-19 ETS (June 28, 2021) (Ex. FED-081)
CMS, Quality, Safety & Oversight Group, QSO-20-30-NH, Nursing Home Reopening Recommendations for State and Local Officials (May 18, 2020; REVISED Mar. 10, 2021; expired Mar. 10, 2021) (Ex. FED-157)
CMS, Quality, Safety & Oversight Group, CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020) (42 C.F.R. 483.80(h) testing; 482.42(e) hospital reporting) and QSO-20-38-NH (Aug. 26, 2020; revised through Sept. 23, 2022) (Ex. FED-168)
CMS, CMS Adult Elective Surgery and Procedures Recommendations (press release and tiered recommendations) (Mar. 18, 2020) (Ex. SEC-01-007)
Food and Drug Administration, Center for Veterinary Medicine, Guidance for Industry #269, Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak (Docket FDA-2020-D-1140) (Mar. 24, 2020) (Ex. SEC-26-001)
Federal Aviation Administration, Aviation Safety, Exemption No. 18537, Regulatory Docket FAA-2020-0412, partial grant of the Air Medical Operators Association's petition (May 1, 2020) (Ex. AGY-AVIATION-SURFACE-023)
