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Is the Secretary for the Department of Health and Human Services Going to Issue an 1135 Waiver?

1135 Waiver(November 2, 2012): As we recently discussed before the East Coast arrival of Hurricane Sandy, Social Security Act Section 1135 Waivers may ultimately be available for healthcare providers in affected areas of New York, New Jersey, Delaware, New England, and surrounding states. 1135 Waivers exist to temporarily waive billing and participation requirements for healthcare providers in emergency situations, absent a finding of fraud or abuse.  If the Secretary of the Department of Health and Human Services (HHS) ultimately issues an 1135 Waiver for Hurricane Sandy, it could waive several requirements, including:

 

  • Conditions of participation or other certification requirements;
  • Program participation requirements for individual providers;
  • Pre-approval requirements;
  • State licensure requirements (as long as the provider is duly licensed in another state);
  • EMTALA requirements;
  • Stark law requirements;
  • Deadlines and timetables for performance of required activities (such as deadlines set out in applicable LCDs and NCDs);
  • Certain Medicare+Choice (Part C) participation requirements; and
  • Certain (but not all) requirements under HIPAA, including the requirement to obtain a patient’s consent for providers to speak with family and friends and the patient’s right to confidential communications. (See Social Security Act Section 1135).

Importantly, these requirements may be waived by the Secretary of HHS, but are not effectively waived until the Secretary actually issues the 1135 Waiver. Don’t assume that just because a disaster occurs, an 1135 Waiver will be forthcoming. Moreover, should auditors find that providers acted in a fraudulent or abusive manner in their billings or arrangements, provisions of the waiver will not apply to those providers. Finally, in no instance can the Secretary waive provisions of the Anti-Kickback Statute (AKS).

Section 1135 allows the Secretary of HHS to ensure that “in any emergency area and during an emergency period . . . sufficient health care items and services are available to meet the needs of individuals in such area  . . . [and that] health care providers that furnish such items and services in good faith, but that are unable to comply with one or more requirements described in subsection (b) [listed above], may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any determination of fraud or abuse.”

While “good faith” and “determination of fraud or abuse” are left undefined and therefore subject to their ordinary meaning, Section 1135 does define “emergency area” and “emergency period.” Specifically”:

An “emergency area” is a geographical area in which, and an “emergency period” is the period during which, there exists

(A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act; and

(B) a public health emergency declared by the Secretary [of HHS] pursuant to section 319 of the Public Health Service Act.

Yesterday, Secretary Sebelius declared a section 319 public health emergency for New York and New Jersey in the wake of Hurricane Sandy. President Obama previously declared an emergency situation for several East Coast jurisdictions, from D.C. to New Hampshire (including New York, New Jersey, Pennsylvania, Connecticut, Maryland and Massachusetts). Accordingly, New York and New Jersey have also been issued 1135 Waivers. Nevertheless, it is important for providers to remember that abusive or fraudulent practices will still be pursued regardless of the presence of 1135 Waivers.

Healthcare LawyerFor more information on the application of an 1135 Waiver or for assistance with Medicare post-payment or pre-payment audits and fraud investigations, contact Robert W. Liles. Robert is the Managing Partner at Liles Parker.  Robert and his team represent health care providers nationwide on this and other health care issues.  For a complimentary consultation, contact Robert today at 1-800-475-1906.

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