HHS Authorizes Section 1135 Waivers to Help Healthcare Providers Cope with H1N1
On Tuesday, October 27, 2009 the Secretary of Health and Human Services invoked her authority under Section 1135 of the Social Security Act to waive certain provisions related to Medicare, Medicaid or the Children's Health Insurance Program (CHIP), the Emergency Medical Treatment and Active Labor Act (EMTALA), the Stark Law, and the Health Insurance Portability and Accountability Act (HIPAA) for healthcare providers who are unable to comply with these requirements as a result of the H1N1 influenza pandemic. Specifically, healthcare facilities may seek waiver of:
- Some Conditions of Participation, certification requirements or other requirements under Medicare, Medicaid and CHIP;
- Physician licensure requirements for providing care in a state if the physician is licensed in another state and the physician is not affirmatively barred from practicing medicine in any state;
- Sanctions for redirection or relocation of an individual to another location to receive a medical screening examination (MSE) if such action is taken pursuant to a state emergency preparedness or pandemic preparedness plan, or for the transfer of an individual after an MSE but before stabilization if the transfer is necessitated by the 2009-H1N1 influenza pandemic;
- Sanctions for certain physician self-referral violations as determined by CMS;
- Reimbursement for services provided by Out of Network providers to Medicare Advantage Plan beneficiaries; and
- Other deadlines and timetables for the performance of required Medicare, Medicaid, and CHIP activities.
Healthcare providers must be proactive in requesting Section 1135 waivers related to the above items if and when they need them to accommodate a high volume of H1N1 patients. According to guidance issued by the Centers for Medicare and Medicaid Services (CMS) on October 27, 2009, healthcare providers can submit a request for a Section 1135 waiver to either the State Survey Agency or CMS Regional Office by phone or email. In their requests for Section 1135 waivers, healthcare providers are required to provide information regarding their specific facility and justification for the request. At this time, CMS has not specified what information regarding the facility will be required. After a facility submits a request for a Section 1135 waiver, cross-regional "Waiver Validation Teams" will review the request to determine whether it is justified and supportable.
While healthcare providers must request a Section 1135 waiver related to the issues discussed above and CMS will determine whether the waiver is necessary, the Secretary’s October 27, 2009 waiver did include a waiver of certain HIPAA requirements, which becomes effective automatically when a hospital activates its “disaster protocol.” For, at most, 72 hours following a hospital’s activation of its disaster protocol, sanctions and penalties arising from noncompliance with the following HIPAA privacy regulations will be waived:
- Requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s require to opt out of the facility directory;
- Requirement to distribute a notice of privacy practices; and
- The patient’s right to request privacy restrictions or confidential communications.
Again, this waiver of sanctions and penalties related to HIPAA is only effective for 72 hours following the hospital’s activation of its disaster protocol. Hospitals should clearly document when they activate their disaster protocols and how they modify their compliance with these HIPAA requirements. Hospitals should also document when they return to their normal HIPAA compliance practices within this 72 hour period. If the hospital activated its disaster protocol prior to the retroactive effective date of the Secretary’s waiver (October 23, 2009), this waiver will offer little relief related to HIPAA.
Healthcare providers must resume their compliance with normal rules and provisions as soon as they are able to do so but no later than the end of the “emergency period,” or, in the case of the HIPAA waiver, within 72 hours of activating a hospital disaster protocol.
While this Section 1135 waiver may provide relief to some healthcare providers, it does not relieve healthcare providers of their obligations under state law nor does it replace protections and relief that may accompany a gubernatorial declaration of emergency related to the H1N1 pandemic.
As additional information about the Section 1135 waiver and request process becomes available, we will share it with you through future e-alert and issues of the “Flu News.”
For more information related to 1135 waivers, please see the following links:
Section 1135 Waiver for H1N1
Requesting a Section 1135 Waiver Guidance from CMS
EMTALA Compliance in Disaster Circumstances
Sharing Information During Disasters: HIPAA Implications
Troutman Sanders LLP has been actively involved in influenza pandemic preparedness planning since 2005 and has prepared a number of white papers and planning guides to assist healthcare providers preparing for emergencies and disasters, including an influenza pandemic response.
To access Troutman Sanders LLP's Pandemic Resource Center, which contains many of the tools that we have developed, please visit http://www.troutman.com/panflu. Please contact Steve Gravely or Erin Whaley for more information on how Troutman Sanders can assist with your pandemic influenza preparedness needs.