As All Hazards Readiness consultants we have been following the Proposed Rule CMS-3178-P with interest since it was slipped into the Federal Register during the holiday season (December 27, 2013). Being  a third party that is largely in the middle of the issues between Providers and the Public, we see our role as one that helps to prevent loss of life and also ensures clients are not exposed to liability for non-compliance, and not overly burdened with redundant regulation and cost. In addition to reviewing the Public Comments, we contacted Congressional and Senate representatives for comments to determine the level of concern for the issue among elected officials. Below are our verbatim Public Comments to CMS as of the cut-off date of the 31^st.  Our comments were based on about 220 comments that were posted by that deadline. Based on a large group of Public Comments from major organizations that were posted in the three days following the deadline, our opinion on a few issues has been reconsidered and will be reflected in upcoming posts as we follow this Proposed Rule through the Final Phase and then into implementation.

Ms. Marilyn Tavenner
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1526-P
P.O. Box 8010
Baltimore, Maryland 21244-8010

Re: CMS-3178-P—Medicare and Medicaid Programs; Emergency Preparedness
Requirements for Medicare and Medicaid Participating Providers and Suppliers

 Dear Ms. Tavenner:

Background

As background to our comments on the proposed rule we want to stress that the most important objective is for the Healthcare Sector to be able to fulfill its’ expected role in the National Response Framework (NRF) in the event of natural and manmade disasters. This is an important point because even with the assumption that a hospital will provide a safe locus of care from a clinical perspective, we cannot assume that the facility will be able to continue operations in situ or after a large scale evacuation – continuity of operations is the key objective of All Hazards planning. The healthcare threat profile is dynamic and is apparently becoming increasingly dangerous; with more frequent and robust natural disasters, evolving infectious diseases, deadlier manmade events in a more hostile global environment.

The issues are not new; President Reagan was the first in the modern era to issue Presidential Directives to upgrade the readiness posture away from the Cold War threats to CBRNE (Chemical, Biological, Radiological, Nuclear and Explosive), largely to account for WMD materials falling into the hands of non-state actors as the USSR disintegrated. The World Trade Center attack #1 and the Oklahoma City Bombing demonstrated that non-state actors using unconventional methods were the threat.

September 11, 2001 Attacks
The ultimate manifestation of this threat profile was the Al Qaeda terrorist attacks of September 11,2001, striking at the heart of America’s Financial, Defense and Transportation systems, permanently altering US domestic and international safety and security posture, and effectively goading the country into two wars and trillions in deficit spending for the sake of security.

In an attempt to ready the Healthcare sector in a post-9/11 world, the newly-formed Department of Homeland Security (DHS) decided to treat the Public and Private healthcare sectors as similar in terms of emergency management requirements, which in retrospect might not have been the best approach given the Private Sector’s long history of avoiding and delaying regulation, i.e., maintaining inventory of PPE, seismic upgrading in earthquake zones, installing redundant utilities systems in flood zones, securing radiological materials that are vulnerable to theft and in-place detonation, etc.

While Federal resources could be and were mandated to achieve a higher level of readiness, the remaining 90% of US healthcare capability (in the Private Sector) could not be enticed or coaxed into meeting a higher level of readiness. Health Sector Emergency Readiness became a hot potato issue, passed back and forth between DHS, DHHS, and CMS, with no ultimate authority in a position to enforce a standard of preparation. The private sector dragged its feet and even DHS could not entice hospitals to adopt the suggested guidance despite Federal Grant programs and resources. The Joint Commission (TJC), a virtual monopoly for the past thirty years, is the giant in the Accreditation market. They have filled the readiness vacuum by accrediting hospitals to operate according to Standards that CMS has until now, deemed satisfactory to meet the Conditions of Participation (CoP).

Hurricane Katrina – 2005
This hurricane came into the Gulf Coast with winds of up to 174MPH, causing catastrophic damage as the levies failed and flooded a large section of New Orleans, LA. It is estimated that the storm caused over 1,800 lives lost, and brought all public and local government services to a standstill in NOLA.

Healthcare casualties numbered over 330; patients expired without electricity to operate life-support equipment, some drowned as water rose above the level of their beds, temperatures climbed over 100 degrees in flooded hospitals and nursing homes. Critical shortages of food, water and medicine prevented care and forced caregivers to make life and death decisions between patients. A FEMA-financed test of the Healthcare Emergency Readiness system (Exercise PAM) predicted a mirror image of the flooding and devastation, including the breach of the levies that isolated healthcare facilities in six foot flood waters that prevented re-supply. Despite these dire warnings, many hospitals did not remove emergency generators and critical supplies (Food, Water and Medicine) from below the flood plain. The decision was made to Shelter in Place rather than evacuate; sealing the fate of the most fragile of the inpatients. All major NOLA hospitals were accredited by TJC or another accrediting body. Post Katrina there have been many other examples of hurricanes that have caused loss of life and property; Rita, and Wilma to name a few.

Hurricane Sandy
Hurricane Sandy produced sustained winds of 115MPH and was named on October 22, 2012. The super-storm hit Cuba hard on the 23^rd would make landfall in the New Jersey/New York area on or around the October 29. President Obama preemptively declared several states Emergency Areas on the 28^th after governors declared States of Emergency on the 26th. In New York City, despite continuous estimates of record flooding, the decision to Shelter in Place was made at many large hospitals in the storm’s path.

NYU’s Langone was forced to backtrack and evacuate a reported over 200 patients down darkened stairwells as the back-up generators failed. At Belleview, the only Level 1 Trauma Center in the Lower Manhattan area, the National Guard had to support the evacuation of that hospital as its’ back up electricity system flooded out. Several other facilities were forced to evacuate and many took weeks or months to re-open. The complete rebuilding program at Langone will come with a share of public money; another large-scale public bailout.

We can only speculate that Hurricane Sandy was the last straw for CMS, but given the billions of taxpayer dollars that have gone to NYC since 9/11 to ensure readiness, the reluctance of the industry to adopt voluntary guidelines and the inability of existing accreditation mechanisms to drive change; it would not come as a surprise.

We reviewed over 200 Public Comments on the proposed rule, and like so many issues in Healthcare today, where people stand on these issues depends largely on where they sit. Comments fall into several groups:

A) Several organizations acting on behalf of members who receive medical services, such as AARP, feel the regulations are both justified and beneficial, while those who advocate on behalf of members who provide services, such as ambulatory surgical services or organ transplant, argue that they are different and should not be held to any specific role beyond their existing scope of services to assist the community in public disasters.

B) The majority of hospital comments come from an Engineering and Facilities perspective and many argue that the new monthly generator testing is wasteful and could actually decrease readiness for technical reasons that involve running the generators using a full load more than once a year.

C) Many hospitals also feel that current NFPA Life Safety Codes overlap with the new CMS requirements, as do those from TJC for Emergency Management and that redundancies should be eliminated, producing a more specific set of standards.

D) Another major point of concern for hospitals was the expectation of self-sustained operations, requiring availability of Food, Potable Water and Medicine to support a major patient surge in case of disaster.

E) In terms of the ability to adopt these requirements, suggestions were made to phase in certain requirements, waive overly onerous requirements depending on applicability of the business model, and grandfather some requirements in for existing facilities and apply them to new construction.

Our position on the proposed rule is somewhere in the middle of what is best for patients and what is possible for providers; with the caveat that corporate financial risk management practice should not apply here – hedging profit risk against a human life is always wrong. And as mentioned at the beginning, the objective here is to be able to provide the safest possible care in the case of disasters.

Our comments in response to proposed bill and other comments include:

A) It will be up to CMS to determine the level of readiness that Ambulatory Surgical Centers provide in case of disasters; it is difficult to force participation for those who would close shop and send employees home during a disaster but at the same time taking out all the surgical capacity they represent seems like a waste. We suggest that better incentives be provided for ASCs to operate during emergencies. More detailed guidance and definition is probably required for organ transplant providers as well. Home Health Provider Guidelines should also be reviewed in our opinion, warranting that there is some accountable entity, whether family or third party, to ensure the safety of the patient in case of All Hazards scenarios.

B) Given the repeated role of flooded generators in evacuations and fatalities, we would suggest that the placement of generators and related equipment required for back up electricity be placed well above the flood plain as a CoP. If the hospital is in a flood prone area and the back-up electricity supply is below the flood plain, it should result in immediate sanction.

C) We also believe that having the whole plan focus on providing patient care would be a step in the right direction. This requires a redefinition of Emergency Management where senior leadership is engaged and responsible for a holistic plan that combines clinical capabilities, all forms of patient care and facilities preparation.

D) A key issue is that healthcare facilities are different than other buildings based on their role, materials and populations. A good Healthcare All Hazards Vulnerability Assessment and Plan will incorporate many sources of guidance to close gaps at the geographic and individual facility level, including NFPA, TJC, State Regulations, OSHA, FEMA, (State)EMA and many others. In addition, there is no single plan that can address the wide range of providers; one size does not fit all. NFPA has significantly tightened Emergency Readiness requirements in the latest guidance and may be the best guidance to cover life safety and certain emergency management provisions. This needs to be integrated with healthcare-specific issues such as in chemicals, gases, biohazards, crowd control, inventory protection and others to create a holistic plan. We have found that one of the biggest gaps tends to be in the external relationships the hospital maintains, making these areas a critical part of the contingency planning.

E) We believe it is not unreasonable to expect a hospital to plan and prepare for a large increase in capacity in a disaster, with Katrina as a worst case scenario, emergency power, food, water, medicine and basic medical consumables were in short supply from the beginning. Some of these requirements seem overly onerous to small hospitals in the areas where substantial retrofitting would be required. Having independent sewage for example, should probably be reviewed on a case by case basis with waivers or grants in some cases.

F) This rule is going to be difficult to implement for many providers, especially considering other important reforms impacting them. We suggest it be phased in over the course of three years, with certain waivers for infrastructure improvements that are not feasible for some small providers.

On a final note, we contacted over a hundred representatives in Congress and the Senate. All leadership, including subcommittee heads in Healthcare, Rules, Homeland Security, Aging, etc. We sent several hundred faxes, emails and phone messages in three waves. We got less than a 1% return rate, and within those no real follow up. Even those who stand up and thump their fists loudest for reform, regardless of party, were nowhere to be found for public quotes on this issue. Go Figure.