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H1N1 Waivers

10/29/09  Rural Oregon

ORH is working closely with OAHHS, CMS, ORHP, and NRHA to receive the latest information on the outbreak and waiver process. We appreciate all the questions we have received and have forwarded them on to ORHP and CMS.

or 503.467.9910 Cell or 503.636.2204 Main. OAHHS is working closely with DHS, CMS and others to determine the steps necessary to get a waiver. We heard from CMS that CAHs will have to be at their 25-bed limit before granted a waiver. Please stay tuned for more information later today from both DHS and OAHHS on this matter.

From CMS


In preparation for National Influenza Vaccination Week (January 10-16, 2010), the Department of Health and Human Services, Centers for Disease Control and Prevention, and the White House Office of Public Engagement will hold an informational conference call with HHS Secretary Kathleen Sebelius on Thursday, January 7, 2010 at 11:00am EST. This call will offer organizations the latest updates on the H1N1 virus and a first-hand preview of plans for National Influenza Vaccination Week. Please find the call-in information below.
  • Title: H1N1 Call *provide in lieu of passcode*
    Participant: (800) 230-1085

Below are a letter from Secretary Sebelius and a one-pager about National Influenza Vaccination Week. We encourage organizations to plan outreach activities, vaccination clinics, or other events during this week to communicate that the H1N1 vaccine is safe, effective, and the best defense against the flu and we ask that you share your plans with us.

While flu illness has declined in many areas, we are only at the beginning of the traditional flu season, which lasts until May. The H1N1 virus is unpredictable and we may see additional waves of illness.

With your help, we now have an opportunity to get ahead of another potential surge in H1N1 and to protect millions of Americans. Participation in this outreach effort is voluntary. To learn more about National Influenza Vaccination Week and how you can get more involved, please visit www.FLU.gov/getvaccinated.

From CDC


CDC 2009 H1N1 Flu Update Tuesday, December 22, 2009 Transcript

On December 22, 2009, the CDC hosted a press conference providing an update on 2009 H1N1 flu and vaccine distribution. A transcript of this press conference is available at the CDC media relations web site.

From OAHHS


Posted 11/18/2009
Over the past week, there has been new information coming from the Oregon Public Health (OPH) Division on H1N1. OAHHS continues to work collaboratively with our state partners to effectively manage communications with our membership. Below you will find information about several new initiatives by the state that will impact your local service areas. Again, please continue to update your HOSCAP data every 24 hours or as the situation dictates.

A Shift in Vaccination Priority Groups:

Vaccinations continue to be in short supply. Oregon has only received 25% of its allotment to fully vaccinate the CDC-recommended priority groups. Oregon Public Health officials continue to monitor the situation closely and rely on the information you provide through HOSCAP to understand daily hospital impact. Because the demand is great, but the supply of the vaccination is low, OPH has reclassified the priority groups until a steady stream of vaccinations to Oregon develops. The new priority groups will be pregnant women and adults and children with a chronic underlying condition or illness. Healthy children and young adults have been removed from the priority groups.

H1N1 Media Campaign Launched:

Yesterday, Oregon Public Health launched a 10-week multi-part media campaign in both English and Spanish for several markets around the state. Below, find a link to a cover memo explaining the campaign in detail and the purchased media schedule. A news conference will be scheduled later this week. The focus of the campaign is around flu prevention and personal hygiene; the goal is 25 media impressions per Oregonian. If you have further questions, please refer them to Patti Wentz, communications director, Oregon Department of Human Services at (503) 947-5361.

Nurse Triage Hotline Established:


Increased utilization of your emergency rooms (ER) has been a critical issue during this flu season. Many times patients present prematurely in the ERs, which further strains the system. Hospitals now have an additional resource to help screen patients before they arrive in your ER with flu-like symptoms. Oregon Public Health has established a nurse triage hotline for the public. The outcomes of the triage line will include: advice on home care, recommendation to seek care from their regular provider, or a referral to a provider, or (if appropriate) referral to the ER. One of the primary goals of this service is to divert patients away from the ER or other providers if self care is the most appropriate course of treatment.
  • Nurse Triage Line: 1-800-978-3040
    Monday-Friday 8:00 am to 6:00 pm

Membership H1N1 Call Follow Up:

We had more than 100 callers to our membership H1N1 check-in call with state officials on November 6. Members provided feedback and the state was appreciative of the opportunity to learn first hand what our members are dealing with on a daily basis around the H1N1 epidemic. OAHHS would like to thank the following presenters:
  • Dr. Mel Kohn, Director, Oregon Public Health Division
  • Dr. Grant Higginson, Oregon Community Health Planning Manager
  • Dr. Larry Mullins, DHA, CEO, Samaritan Health Services
  • Becky Pape, CEO Samaritan Lebanon Community
  • Win Howard, CEO, Three Rivers
  • Will Bean, Emergency Preparedness Coord., Mt. View Hospital

OAHHS will host additional informational membership calls with state officials as the situation dictates throughout the remainder of the flu season. Please keep us informed about your current situation and we will do what we can to assist.

Posted 11/02/2009
After President Obama declared a national state of emergency due to the spread of the H1N1 virus, questions have been raised about what that really means for Oregon hospitals from a regulatory and legal standpoint. OAHHS continues to work directly with AHA, CMS and Oregon’s Public Health Division to get clearer guidance for our hospitals.

On Tuesday, October 27, United States Health and Human Services Secretary Sebelius enacted a waiver under section 1135 of the Social Security Act allowing hospitals to petition their state survey agency or their CMS Regional Office for specific section 1135 waivers. At our request, we learned from Oregon's Public Health Division that CMS has released a detailed process for initiating waivers. These waivers can include Pre-authorization requirements; Medicare Conditions of Participation; certification requirements, program participation requirements; physician state licensure requirements (as they relate to payment under Medicare/Medicaid); actions under EMTALA; sanctions under the Stark Self-Referral regs.; payment limitations for out-of-network services under Medicare+Choice; HIPAA privacy sanctions and penalties; deadlines and timetables.

Two specific issues we have heard from you about relate to the use of alternative care sites and the easing of Critical Access Hospital bed limits. It is important that you understand the criteria before initiating the waiver process for your hospital.

General Guidelines:
  • Each hospital's waiver request will be reviewed individually and granted/denied on a case-by-case basis.
  • A region or health system will not be allowed to request waivers for all their hospitals in specific regions or throughout their system.
  • Granted waivers should be good for 60 days or the end of the emergency, whichever is shorter.
  • It would be helpful but not necessarily required to have citations for the specific regulatory standards a hospital wants waived.
  • The most important thing is to be very clear on what the hospital wants waived and the justification for the need.

Here are some specifics related to the two most requested issues noted above:

Hospitals request to set up an alternative screening location for patients away from the hospital's main campus (requiring waiver of the Emergency Medical Treatment and Labor Act-EMTALA)
  • Has the Hospital initiated its Disaster Response Plan (a necessary pre-condition prior to operating under an EMTALA waiver)?
  • Are other hospitals nearby experiencing similar needs?
  • Does this hospital provide services to a specialized population (such as a Children's hospital)?
  • Are other hospitals in the area at or near capacity (verified through direct conversations with neighboring hospitals or Oregon’s HOSCAP system.
  • This information will need to be provided by the hospital and verified by the state survey agency, accrediting organization and/or the CMS regional office, if deemed necessary. This may require an onsite visit by one of these entities.

Critical Access Hospitals requesting waiver of 42 CFR 485.620 which requires a 25-bed limit and average patient stays less than 96 hours
  • Is the CAH at or near the 25-bed capacity limit?
  • Have any patients exceeded the 96-hour length of stay? How many?
  • Are other hospitals willing to take the patients in transfer? If not, why not?
  • This information will need to be provided by the hospital and verified by the states survey agency, accrediting organization and/or the CMS regional office, if deemed necessary. This may require an onsite visit by one of these entities.

Process for Initiating a Section 1135 Waiver:
  • 1. Hospital identifies the need for a waiver.
  • 2. Hospital completes the first 7 cells of the CMS 1135 Waiver Specific Provider Tracking spreadsheet. (there is one SAMPLE and one blank. On the blank form we have filled in the State Agency Contact – Ron Prinslow).
  • 3. Hospital works with county emergency manager and/or local health department to get the request into the state’s OpsCenter.
  • 4. Hospital faxes a copy to the Oregon Public Health Division AOC at the same time to 971-673-0075.
  • 5. Request is received by the AOC and tasked to Ron Prinslow at Health Care Licensure & Certification (HCLC - Oregon’s State Agency).
  • 6. HCLC reviews request, confers with the CMS Regional Office.
  • 7. CMS makes the decision to approve or deny.
  • 8. Notification of the decision is provided to the requesting hospital, local emergency manager, local health department, Healthcare Preparedness Program regional coordinator, and Health Care Licensure & Certification.
  • 9. Process time from a completed request entered into OpsCenter and notification of a decision should be less than 2 business days and usually within 24 hours.

Notes:
  • Processing may be delayed if inadequate justification is provided. Please review the attached Waiver Criteria sheet to see the level of detail being requested.
  • Processing may also be delayed if the request is sent directly to the CMS Regional Office (even though some federal government materials say this may be done). The State Agency will be involved in all waiver decisions so going though the procedure described above should expedite the process.
  • If there is an emergency need for a waiver after hours, the requesting hospital should page the PH Emergency Preparedness duty officer at (503)938-6790 (preferable), or call mobile phone (971-673-1789) or contact through OERS at 1-800-452-0311. The duty officer will contact a HCLC representative as needed.
  • Healthcare Preparedness Program Regional Coordinators are available to facilitate the process between a hospital and its local emergency manager upon request.
  • This is a new process and may need to be modified over time. You will be notified of any changes.

OAHHS will continue to provide detailed updates surrounding H1N1 issues as necessary. Remember that you can contact us 24/7 by calling Andy Van Pelt at 503-475-3697 or

In the meantime, please continue to update your HOSCAP data daily and remain in close contact with your public health department.

From DHS


Posted 11/02/2009
Public Health Division staff had a conference call with Regional CMS staff this morning about SSA 1135 waivers. They promise to have definitive guidance out by COB tomorrow (Thurs 10-29) regarding waivers allowable under the National State of Emergency declared by President Obama on Oct 24, 2009. In the meantime, they recommend that we all become familiar with the information on the following website: http://www.cms.hhs.gov/H1N1/. There is also some basic information gained from CMS below.
  • Each hospital's waiver request will be reviewed individually and granted/denied on a case-by-case basis.
  • A region or health system will not be allowed to request waivers for all their hospitals in specific regions or throughout their system.
  • Granted waivers should be good for 60 days or the end of the emergency, whichever is shorter.
  • While definitive information should be out tomorrow, CMS agrees with us that all waiver requests should come to our AOC through OpsCenter so that all parts of the emergency response system know what's happening. That means you should be working with your local emergency manager(s). This should actually speed up rather than slow down the process.
  • It would be helpful but not necessarily required to have citations for the specific regulatory standards a hospital wants waived. The most important thing is to be very clear on what the hospital wants waived and the justification for the need.
  • Once a fully completed request is entered into OpsCenter, we will work directly with CMS to get it processed within 2 business days and hopefully within 24 hours.
  • CMS informed us that information on reciprocity (implementing changes first and obtaining a waiver later) will be included in the guidance issued tomorrow.

I hope this is helpful. We will get the CMS information and a well defined process for requesting a waiver out to you as soon as possible.

Grant Higginson, MD. MPH
Administrator, Office of Community Health & Health Planning
Public Health Division, Department of Human Services

From ORHP


Posted 11/02/2009
We have received a number of questions regarding waivers to the CAH bed limit requirement due to high volumes of H1N1 patients. There are three steps to this process, two of which are already complete: The President declares a National Emergency , The Secretary declaring a Public Health Emergency, and the Secretary’s waiver authority which allows for waivers to the requirement in certain cases only to the extent necessary as determined by CMS. In order for a CAH to request a waiver to the bed limit requirement, they need to request a wavier through their CMS Regional Office. CMS is not approving pre-emptive waivers, meaning that the CAH needs to be able to document their specific need for increasing the bed limit. CMS is working to develop an expedited waiver review process and identifying point people for these waivers in each of the regional offices. To find out more information on requesting waivers visit http://www.cms.hhs.gov/H1N1/. The CMS Regional Office Rural Health Coordinators may also be a resource.

Caroline Cochran
Deputy Associate Administrator | Office of Rural Health Policy
v: (301) 443 4701 | f: (301) 443 2803


From NRHA


Posted 11/02/2009
In response to the recent H1N1 (Swine Flu) outbreak, President Obama and HHS Secretary Kathleen Sebelius have officially declared a national state of emergency which, among other things, will allow critical access hospitals to file a request to CMS that would temporarily waive the daily limit of twenty-five occupied beds for critical access hospitals. Though this does not indefinitely lift the limit, nor does it apply to any bed limits for which H1N1 patients are not a contributing factor, it does seek to address the current outbreak and address for surges in patient loads.

The waiver is not automatic, and each CAH must submit an individual request to be reviewed by CMS in order for it to be granted. CAHs with high patient loads due specifically to H1N1 should submit a request as soon as possible. The request must include the following information and be sent to their regional CMS office. (Click on the link for your region at the bottom of the page)

Name
City and State
Provider Number
Hospital Main Contact Person and Contact Information - Phone number, etc
Explanation/Reason for waiver request
Number of beds over the limit and duration of beds occupied as a result of the reason for which you are filing the waiver

Unfortunately, the first question you may ask (how are we to know how long the duration will be?) is not specifically answered by CMS, and CMS will not issue a waiver prior to actually exceeding the bed count. Still, we urge you to request this waiver if your hospital is either getting close to the limit or as soon as possible after that limit is reached and exceeded (All the more reason we need Congress to pass legislation allowing permanent bed flexibility!)


This declaration was made official just this week when Secretary Sebelius exercised her authority to waive or modify Section 1135 of the Social Security Act. This authority allows her to temporarily waive certain Medicare, Medicaid, and Childrens Health Insurance provisions "to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods and that providers who provide such services in good faith can be reimbursed and exempted from sanctions."

This was in response to efforts by the NRHA, as well as Congressional offices who have talked to CAHs in their states and districts, and is great news for CAHs who are concerned that the potential surge of H1N1 affected patients are not turned away from treatment.