Federal declaration of a public health emergency

Biosecurity and Bioterrorism

Volumn 7, Issue 3, 2009, Pages 251-258

  Ray, Jennifer ^a  

^a U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DISASTER; GOVERNMENT; HUMAN; LEGAL ASPECT; PUBLIC HEALTH; UNITED STATES;

DISASTERS; HUMANS; PUBLIC HEALTH; UNITED STATES; UNITED STATES DEPT. OF HEALTH AND HUMAN SERVICES;

EID: 70350468697     PISSN: 15387135     EISSN: None     Source Type: Journal    
DOI: 10.1089/bsp.2009.0039     Document Type: Article

References (39)

1. Section 2801(a) of the PHS Act (42 U.S.C. § 300hh(a) (2009)).
2. National Response Framework. January 2008. http:==www. fema.gov=emergency=nrf=. Accessed July 31, 2009. HHS is also a support agency for other ESF Annexes, including ESF 3, 5, 7, 9, 10, 11, 14, and 15.
3. Section 2811(b)(1) of the PHS Act (42 U.S.C. § 300hh- 10(b)(1) (2009)).
4. Hoffman S, Goodman R, Stier D. Law, liability, and public health emergencies. Disaster Medicine and Public Health Preparedness 2008;3(1):2.
5. Section 319 of the PHS Act (42 U.S.C. § 247d (2009)). The secretary is required to consult with such public health of- ficials as may be necessary before making a determination.
6. H.R. Rep. 98-143, U.S.C.A.A.N. (1983).
7. Section 319 of the PHS Act was modified in 2000 by the Public Health Improvement Act, Pub. L. No.106-505, which repealed the former section 319 and inserted a new section 319. However, the new language was substantially similar to the 1983 version. The new version clarified that a PHE includes ''significant outbreaks of infectious disease or bioterrorist attacks'' and that the PHEF could be used only if the secretary declares a PHE under section 319. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188, modified section 319 by inserting several new provisions. Pub. L. No. 107-188 added ''providing awards for expenses'' as an action the HHS Secretary may take to respond to a PHE, added a termination provision clarifying when the public health emergency ends and establishing a renewal option, and added subsection (d), which allows the secretary to extend deadlines and waive sanctions relating to data or reports that individuals are required to submit under laws administered by HHS.
8. Section 319(b) of the PHS Act (42 U.S.C. § 247d(b) (2009)).
9. Beginning in 2001, Congress has appropriated either supplemental or annual appropriations to a ''Public Health and Social Services Emergency Fund'' to, among other things, support activities related to countering potential biological, disease, and chemical threats to civilian populations and for pandemic flu preparedness activities. See, eg, Pub. L. No.107-38 (Sept. 18, 2001), Pub. L. No. 107-117 ( January 10, 2002), Pub. L. No. 108-199 ( January 23, 2004), etc.
10. See discussions of Federal-to-Federal Support and definition of a mission assignment in Department of Homeland Security. National Response Framework. January 2008. http:==www. fema.gov=emergency=nrf=. Accessed July 31, 2009.
11. Section 319(a) of the PHS Act (42 U.S.C. § 247d(a) (2009)).
12. Section 319(d) of the PHS Act (42 U.S.C. § 247d(d) (2009)).
13. Eg, see sections 301, 311, and 2812 of the PHS Act (42 U.S.C. §§ 241, 243, and 300hh-11 (2009)).
14. 42 U.S.C. § 243 (2009).
15. 42 U.S.C. §§ 241, 247d-6b, 264, 300hh-11, and 300hh-15.
16. 42 U.S.C. § 1320b-5 (2009).
17. 21 U.S.C. § 360bbb-3 (2009).
18. Section 351A(g)(3) of the PHS Act (42 USC § 262a) (2009).
19. 21 U.S.C. § 355-1(f)(7) (2009).
20. Section 1847A of the SSA (42 U.S.C. § 1395w-3a (2009)).
21. 42 U.S.C. § 300ff-83 (2009).
22. 5 C.F.R. 213.3102(i)(1), 5 U.S.C. §§ 8344, 8468 (2009).
23. Section 1135(a) of the SSA (42 U.S.C. § 1320b-5(a) (2009)).
24. Section 1135(g) of the SSA (42 U.S.C. § 1320b-5(g) (2009)).
25. Section 1135(b) of the SSA (42 U.S.C. § 1320b-5(b) (2009)).
26. This is for purposes of Medicare, Medicaid, or CHIP reimbursement only.
27. For more discussion of EMTALA waivers, see Courtney B. Waiving EMTALA sanctions in response to public health emergencies. Biosecur Bioterror 2008;6(3):213-217.
28. For additional information about the application of HIPAA during public health emergencies (whether or not the secretary makes a formal PHE declaration under section 319 of the PHS Act, or issues an 1135 waiver), see U.S. Department of Health and Human Services. Health Information Privacy: Emergency Preparedness Planning and Response. http:==www.hhs. gov=ocr=privacy=hipaa= understanding=special=emergency= index.html. Accessed July 31, 2009.
29. Section 1135(c) of the SSA (42 U.S.C. § 1320b-5(c) (2009)).
30. Section 1135(e) of the SSA (42 U.S.C. § 1320b-5(e) (2009)). This section provides that a waiver may also last until the presidential declaration expires. However, since Stafford Act declarations generally last for up to a year or more after the event until all funding programs provided under that Act for a particular event are terminated, HHS usually terminates an 1135 waiver on the same date that the PHE is terminated.
31. The HHS Secretary may have declared a PHE under section 319 in the 1980s in response to the AIDS epidemic, although the author could not confirm whether this action was taken.
32. Besides September 11, 2001, HHS has issued PHE declarations in response to Hurricanes Katrina and Rita in 2005, Hurricane Dean in 2007, severe flooding in Indiana and Iowa in 2008, Hurricanes Gustav and Ike in 2008, the 2009 Presidential Inauguration, severe flooding in North Dakota and Minnesota in 2009, and the 2009 H1N1 influenza outbreak. For declarations and 1135 waivers related to hurricanes, see http:==www.cms.hhs.gov=Emergency=02- Hurricanes.asp#TopOfPage. Accessed July 31, 2009. For declarations and 1135 waivers related to severe flooding, see http:==www.cms.hhs.gov=Emergency=12- StormFlood.asp# TopOfPage. Accessed July 31, 2009. For the H1N1 influenza outbreak declaration, see http:==www.hhs.gov=secretary= phe-swh1n1.html. Accessed July 31, 2009.
33. U.S. Department of Health and Human Services. FDA authorizes emergency use of influenza medicines, diagnostic test in response to swine flu outbreak in humans [press release]. April 27, 2009. http:==www.fda.gov=NewsEvents= Newsroom=PressAnnouncements=ucm149571.htm. Accessed July 31, 2009.
34. The secretary did not ultimately need to issue an 1135 waiver for the 2009 Presidential Inauguration. For 1135 waivers related to hurricanes, see http:==www.cms.hhs.gov= Emergency=02-Hurricanes.asp#TopOfPage. Accessed July 31, 2009.
35. For 1135 waivers related to severe flooding, see http:==www.cms.hhs.gov= Emergency=12-StormFlood.asp# TopOfPage. Accessed July 31, 2009.
36. The author could not locate specific information pertaining to the PHE declaration for September 11, 2001.
37. U.S. Department of Health and Human Services. Centers for Medicare & Medicaid Services. CMS Response to the Hurricane Emergency-Gustav=Ike Medicare Fee-For-Service. October 3, 2008 (relating to Medicare requirements and Hurricanes Gustav and Ike, including in part flexibilities relating to 1135 waiver authority). http:==www.cms.hhs. gov=Emergency=Downloads=GustavMasterQsAs- 100308. pdf. Accessed July 31, 2009.
38. U.S. Department of Health and Human Services. Centers for Medicare & Medicaid Services. Provider Survey and Certification Frequently Asked Questions, Declared Public Health Emergencies-All Hazards. August 31, 2008. http:==www.cms.hhs.gov=SurveyCertEmergPrep=Downloads= AllHazardsFAQs.pdf. Accessed July 31, 2009.
39. For more information about EMTALA and alternative care facilities during a pandemic, see U.S. Department of Health and Human Services. Centers for Medicare & Medicaid Services. Fact Sheet-Emergency Medical Treatment and Labor Act (EMTALA) & Surges in Demand for Emergency Department (ED) Services During a Pandemic. August 14, 2009. http:==www.cms.hhs.gov= SurveyCertificationGenInfo= downloads=SCLetter09-52.pdf. Accessed August 25, 2009.