Occupational Safety and Health Administration, 29 C.F.R. 1910.1030 (bloodborne pathogens) (standing) (Ex. DUT-FED-007)
Occupational Safety and Health Administration, 29 C.F.R. 1910.134 (respiratory protection) (standing) (Ex. DUT-FED-004)
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)
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)
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)
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)
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, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (consolidated document; version updated May 24, 2021) (Mar. 13, 2020) (Ex. FED-160)
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)
CMS (Secretary of HHS), COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (Mar. 30, 2020) (Ex. SEC-02-005)
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)
Centers for Medicare & Medicaid Services, CMS-1744-IFC, 85 Fed. Reg. 19230 (Apr. 6, 2020) (Ex. SEC-04-017)
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)
CMS, Center for Clinical Standards and Quality / Quality, Safety & Oversight Group, CMS QSO-20-13-Hospitals (Mar. 4, 2020), QSO-20-14-NH (Mar. 13, 2020), QSO-20-18-HHA (Mar. 10, 2020) (Ex. FED-096)
CMS, Quality, Safety & Oversight Group, QSO-20-13-Hospitals-CAHs (REVISED) (Mar. 4, 2020) (Ex. SEC-01-006)
Centers for Medicare & Medicaid Services (approval) on the application of the Pennsylvania Department of Human Services, Office of Long-Term Living, Appendix K: Emergency Preparedness and Response and COVID-19 Addendum to the Community HealthChoices and OBRA 1915(c) waivers (combined; final amendment fixing the end date) (Mar. 6, 2020) (Ex. SEC-04-078)
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)
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)
CMS, Quality, Safety & Oversight Group, QSO-20-14-NH, Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (Mar. 9, 2020; REVISED Mar. 13, 2020) (Ex. FED-097)
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)
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 (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)
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)
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)
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, COVID-19 Public Health Emergency Response and 42 CFR Part 2 Guidance (Mar. 19, 2020) (Ex. AGY-FED-HEALTH-OTHER-027)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Secretary of Health and Human Services, Emergency Use Authorization Declaration: drugs and biological products (Mar. 27, 2020) (Ex. FED-184)
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)
Rear Admiral E. C. Jones, Commander, Seventh Coast Guard District, Miami, Florida, Seventh District MSIB 01-20 (Mar. 29, 2020) (Ex. AGY-USCG-PORTS-013)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Centers for Medicare & Medicaid Services (condition of participation for long-term care facilities), 42 C.F.R. 483.80 (infection control; COVID-19 reporting; COVID-19 testing) (standing) (Ex. DUT-FED-023)
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)
CMS, Quality, Safety & Oversight Group, QSO-20-29-NH and CMS-5531-IFC, 85 Fed. Reg. 27550 (May 8, 2020): 42 C.F.R. 483.80(g) reporting (May 6, 2020) (Ex. FED-161)
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, CMS-5531-IFC, 85 Fed. Reg. 27550 (May 8, 2020) (Ex. SEC-04-006)
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)
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)
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)
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)
Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Gowns and Other Apparel (umbrella) (May 22, 2020) (Ex. AGY-FED-HEALTH-OTHER-054)
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)
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)
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-165)
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)
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)
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)
Centers for Disease Control and Prevention, Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic (updated July 15, 2020) (Ex. DUT-FED-060)
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)
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 (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)
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-166)
Federal Aviation Administration, Aviation Safety, Exemption No. 18537B, Regulatory Docket FAA-2020-0412 (partial grant of AMOA's petition of July 20, 2020 to extend and amend Exemption 18537A) (Aug. 19, 2020) (Ex. AGY-AVIATION-SURFACE-026)
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)
Centers for Medicare & Medicaid Services (hospital condition of participation), 42 C.F.R. 482.42 (hospital infection prevention and control and antibiotic stewardship programs; COVID-19 reporting) (standing) (Ex. DUT-FED-024)
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)
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, Department of Health and Human Services, CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020) (Ex. SEC-04-004)
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)
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)
CMS, Quality, Safety & Oversight Group, QSO-20-39-NH, Nursing Home Visitation - COVID-19 (original, Sept. 17, 2020) (Ex. FED-154)
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)
