November 16, 2018
Administrator Seema Verma
Facilities for Medicare & Medicaid Providers
Division of Well being and Human Providers
P.O. Field 8010
Baltimore, MD 21244-1810
Re: CMS-3346-P; Federal Register, Vol. 83, No. 183 (September 20, 2018).
Submitted electronically: www.laws.gov.
Pricey Administrator Verma,
The Lengthy Time period Care Group Coalition (LTCCC) is a non-profit group devoted to enhancing care, high quality of life, and dignity for residents in nursing houses and different long-term residential care settings. For over 25 years, we have now carried out coverage research and analyses of nursing residence legal guidelines, requirements and their implementation. Along with our work on systemic long run care points, we work intently with residents, households, and advocates to enhance care.
The Center for Medicare Advocacy (Center) is a nationwide, personal, non-profit regulation group, based in 1986, that gives schooling, evaluation, advocacy, and authorized help to individuals nationwide, primarily the aged and individuals with disabilities, to acquire essential well being care, remedy, and Medicare. The Center focuses on the wants of Medicare beneficiaries, individuals with persistent circumstances, and these in want of long-term care and supplies coaching relating to Medicare and well being care rights all through the nation. It advocates on behalf of beneficiaries in administrative and legislative boards, and serves as authorized counsel in litigation of significance to Medicare beneficiaries and others in search of well being protection.
Overview of Comments
The Facilities for Medicare & Medicaid Providers (CMS) issued a discover of proposed rulemaking (NPRM) to permit nursing houses to evaluate their emergency preparedness packages and practice employees to hold out these plans each two years quite than yearly. LTCCC and the Center strongly consider nursing house residents shall be at a higher danger of hurt and even demise if the emergency preparedness necessities have been to be rolled again. Subsequently, we respectfully urge CMS to not finalize the proposed rule.
On December 27, 2013, CMS proposed emergency preparedness guidelines to deal with well being care suppliers’ and suppliers’ lack of enough preparedness for pure and human-made disasters. The proposed guidelines mentioned a number of current emergencies, together with the next disasters:[T]he 2009 H1N1 influenza pandemic, the 2001 anthrax assaults, the tornados in 2011 and 2012, and Hurricane Sandy in 2012. In 2014, america confronted various new and rising illnesses, resembling MERSCoV and Ebola, and a nationwide outbreak of Enterovirus D68, which was confirmed in 938 individuals in 46 states between mid-August and October 21, 2014 . . . .”
Almost 400 members of the general public submitted feedback. CMS finalized the rule on September 16, 2016, figuring out 4 key elements of catastrophe preparedness: (1) danger evaluation and emergency planning, (2) insurance policies and procedures, (three) communication plan, and (four) coaching and testing. 
Because the Remaining Rule was revealed two years in the past, and carried out only one yr in the past, pure and human-made disasters have continued: 12 residents at a Florida nursing residence died in 2017 when their facility misplaced its air-conditioning, 10 youngsters at a New Jersey pediatric nursing residence died of Adenovirus in 2018, and wildfires have raged in California.
Regardless of these disasters, CMS issued a NPRM on September 20, 2018, to as soon as once more revise the emergency preparedness program necessities. Most notably, the proposed rule would permit nursing houses to assessment their emergency preparedness packages and to coach employees to hold out these plans simply as soon as each two years as an alternative of yearly.
CMS’s proposed rule is a rollback of important nursing house resident protections. The target of this rollback is to scale back the so-called “burden” on nursing houses; the NPRM even notes that the proposed modifications would save “burden hours.” Making certain that nursing house residents are protected throughout growing instances of pure and human-made disasters should not be seen as a burden. Nursing houses that voluntarily take part within the Medicare and Medicaid packages in an effort to obtain public cash, should adhere to the minimal requirements of care established by regulation and regulation to offer high quality care to residents and safeguard their high quality of life. Time spent defending residents isn’t a burden and shouldn’t be quantified as such.
Nursing house residents, a few of the most weak people in our nation, are positioned at a considerably larger danger of hurt and dying throughout emergencies. As an example, 12 residents at a Florida nursing house died final yr when Hurricane Irma minimize energy to the power’s air con system. The nursing house’s poor response to the catastrophe resulted within the county medical expert ruling the deaths a murder. In Texas, throughout Hurricane Harvey, a number of nursing houses and assisted dwelling amenities flooded. Pictures from one Texas nursing residence confirmed 15 residents sheltering-in-place in waist-deep water. Instances of poor emergency preparedness, amounting to resident abuse and neglect, have develop into more and more widespread.
With a view to shield residents, nursing houses have to evaluation emergency preparedness packages and practice employees yearly. In line with a post-Hurricane Katrina report by the HHS Workplace of the Inspector Common (OIG) in 2006, nursing house residents have been positioned in hurt’s method throughout a collection of hurricanes across the Gulf Coast. The OIG reported that directors and employees from pattern nursing houses didn’t all the time comply with emergency plans or needed to transcend the small print of these plans “either because the plans were not updated or plans did not include instructions for particular circumstances.”
In a follow-up 2012 report, the OIG discovered ongoing issues with emergency planning. Pattern nursing houses reported challenges in responding to emergencies, together with problem following emergency plans as written and logistical issues. Some directors acknowledged that “their emergency plans did not contain accurate or detailed information on how to execute their plans and respond to disasters.”
Pure and human-made disasters aren’t more likely to comply with any singular type or sample. These emergencies differ from year-to-year, relying on elements outdoors the management of nursing residence operators and employees. The OIG’s studies point out that poorly developed or outdated emergency packages might end in employees making an attempt to fill in gaps throughout emergencies in real-time. Nursing residence employees must be educated about their facility’s emergency preparedness plans always. Employees shouldn’t should recall classes from two years in the past or rely on the information of newer, inexperienced employees throughout emergencies.
It’s inappropriate to say that the emergency preparedness necessities are burdensome after lower than a yr of implementation. The emergency preparedness necessities have been lately revised in a 2016 Ultimate Rule and the laws solely began being carried out in November of 2017. The brand new necessities have been nonetheless not being carried out when residents on the Florida nursing residence died in September of 2017 and when the Texas nursing residence flooded in August of that very same yr. Even after the laws have been carried out, Republican members of the Home Power and Commerce Committee nonetheless needed to know what CMS was doing or might be doing to guard nursing house residents. In line with the Committee members, “reports raise serious questions about the degree to which the Centers for Medicare and Medicaid Services (CMS) is fulfilling its responsibility to ensure federal quality of care standards are being met, as well as its duty to protect vulnerable seniors from elder abuse and harm in facilities participating in the Medicare and Medicaid programs.” Rolling again resident protections runs counter to the underlying efforts of current Congressional oversight.
Claims that the emergency preparedness necessities are burdensome contradict CMS’s personal justification for implementing the 2016 Last Rule. When the necessities have been finalized in 2016, CMS said that it disagreed with those that “stated that the emergency preparedness regulations are inappropriate or unnecessary.” Actually, CMS acknowledged that “without proper training, healthcare workers may find it difficult to implement emergency preparedness plans during an emergency or disaster.” CMS now proposes to rollback protections it deemed needed two years in the past, and which have been solely carried out one yr in the past, in an inappropriate effort to satisfy President Trump’s “Reducing Regulation and Controlling Regulatory Costs” Government Order. CMS’s obligation to stick to the President’s order shouldn’t be on the expense of important resident protections, with out clear proof indicating that rolling again these protections would truly enhance resident well being, security, and well-being.
Nursing house residents should not have their rights and protections rolled again to be able to scale back so-called “burdens” on nursing houses. The deaths of 12 nursing house residents in Florida after Hurricane Irma and the flooding of a Texas nursing residence after Hurricane Harvey are solely current examples of why emergency preparedness necessities are mandatory for making certain resident care and high quality of life. Because the HHS Workplace of the Inspector Basic indicated in a number of reviews over a few years, nursing houses aren’t capable of shield residents throughout pure or human-made disasters with out sufficient planning and coaching. Permitting nursing houses to evaluation their emergency preparedness packages and practice employees each two years as an alternative of yearly will place residents at a good larger danger of hurt and even demise.
Dara Valanejad, Coverage Lawyer
Lengthy Time period Care Group Coalition
Center for Medicare Advocacy
Richard J. Mollot, Government Director
Lengthy Time period Care Group Coalition
Toby S. Edelman, Senior Coverage Lawyer
Center for Medicare Advocacy
Marilyn Burnett, Fellow
Lengthy Time period Care Group Coalition
 Medicare and Medicaid Packages; Emergency Preparedness Necessities for Medicare and Medicaid Collaborating Suppliers and Suppliers, 78 Fed. Reg. 79,082, 79,084 (Dec. 27, 2013), https://www.gpo.gov/fdsys/pkg/FR-2013-12-27/pdf/2013-30724.pdf.
 Medicare and Medicaid Packages; Emergency Preparedness Necessities for Medicare and Medicaid Collaborating Suppliers and Suppliers, 81 Fed. Reg. 63,860, 63,862 (Sept. 16, 2016), https://www.gpo.gov/fdsys/pkg/FR-2016-09-16/pdf/2016-21404.pdf.
 Medicare and Medicaid Packages; Regulatory Provisions To Promote Program Effectivity, Transparency, and Burden Discount, 83 Fed. Reg. 47,725-47,727.
 Medicare and Medicaid Packages; Regulatory Provisions To Promote Program Effectivity, Transparency, and Burden Discount, 83 Fed. Reg. at 47,725.
 Sheltering in Hazard: How Poor Emergency Planning and Response Put Nursing House Residents at Danger Throughout Hurricanes Harvey and Irma, U.S. Senate Committee on Finance, Minority Employees (Nov. 2018), https://www.finance.senate.gov/imo/media/doc/Sheltering%20in%20Danger%20Report%20(2%20Nov%202018).pdf.
 Daniel R. Levinson, Nursing House Emergency Preparedness and Response Throughout Current Hurricanes, HHS OIG (Aug. 2006), https://oig.hhs.gov/oei/reports/oei-06-06-00020.pdf.
 Daniel R. Levinson, Gaps Proceed to Exist in Nursing Residence Emergency Preparedness and Response Throughout Disasters: 2007-2010, HHS OIG (Apr. 2012), https://oig.hhs.gov/oei/reports/oei-06-09-00270.pdf.
 Medicare and Medicaid Packages; Emergency Preparedness Necessities for Medicare and Medicaid Collaborating Suppliers and Suppliers, 81 Fed. Reg. 63,869.
 Sheltering in Hazard: How Poor Emergency Planning and Response Put Nursing House Residents at Danger Throughout Hurricanes Harvey and Irma, U.S. Senate Committee on Finance, Minority Employees.
 Letter from the Home of Representatives, Committee on Power and Commerce, to CMS Administrator Seema Verma (Apr. 2, 2018), https://energycommerce.house.gov/wp-content/uploads/2018/04/20180402CMS.pdf.
 Medicare and Medicaid Packages; Emergency Preparedness Necessities for Medicare and Medicaid Collaborating Suppliers and Suppliers, 81 Fed. Reg. at 63,863.
 Medicare and Medicaid Packages; Regulatory Provisions To Promote Program Effectivity, Transparency, and Burden Discount, 83 Fed. Reg. at 47687.