Changes Are Likely on the Horizon for the Federal Healthcare Portfolio in Areas Including Cybersecurity and Regulatory Enforcement Bond Schoeneck King PLLC JDSupra
pppFederal healthcare administration undoubtedly will look different in 2025 than it does as we close 2024ppIn the aftermath of the Republican party victories during this months Federal elections and if the past is prelude the Federal focus concerning the healthcare sector will be shifting We will move away from a Biden administration predisposition to engage in detailed regulatory and oversight processes to a posture in a second Trump administration much as in the first one focused on deregulation and lesser agency engagement And unlike in the first term of President Trump the administration may be emboldened by jurisprudence such as the June 2024 Supreme Court Loper Bright v Raimondo decision which shifts the nature of courts deference to agency determinations generallyppHHS and HIPAA Security Rule EnforcementppDuring the end of October Mr Oberfield in his capacity as a member of the Federal 405d task group attended a twoday Federal conference on healthcare cybersecurity Safeguarding Health Information Building Assurance through HIPAA Security 2024 conference materials available here Governmental presenters covered a variety of topics including but not limited to the role of the Department of Health and Human Services in regulating healthcare providers adherence to data safety standards The talk of the conference was a proposed omnibus regulatory update to the Health Insurance Portability and Accountability Act of 1996 HIPAA security standards including the October engagement Federal Office of Management and Budget in reviewppOther topics on the agenda included medical device cybersecurity and several presentations from HHS divisions including its Office for Civil Rights And on the heels of the conference just before November OCR announced a number of enforcement actions concerning shortcomings it observed in health providers upstream risk analysis efforts see eg fines levied against Plastic Surgery Associates of South Dakota and Bryan County Ambulance AuthorityppIt is evident that the Republican victories could affect the rollout of various HHS priorities including the completion of OMBs review and the enforcement prerogatives of OCR This would not be a surprise to the extent the first Trump administration made the diminishment of regulation generally a key priority including through the appointment of a regulatory reform task force among other initiatives Moreover during President Trumps first term OCR focused on issues including objections by healthcare providers in performing certain duties on religious conscience grounds occupying a space quite distinct from one focused on providers security rigor ppSkilled Nursing is Just One of Many Arenas Likely to Shift in Trump AdministrationppThe Security Rule is only one aspect of the Federal healthcare portfolio likely to see change come January 20th In long term care the outgoing Biden administration has focused on facility staffing as a patient safety vehicle for skilled nursing facilities Relatedly the Centers for Medicare and Medicaid Services CMS issued a final rule introducing minimum staffing standards for the purpose of ensuring safety and quality of the services provided to residents of long term care facilities certified by Medicare and Medicaid See 89 Fed Reg 40876 40876 May 10 2024 The rule requires covered facilities to meet or exceed a minimum of 348 hours per resident day for total nurse staffing including but not limited toppi A minimum of 055 hours per resident day for registered nurses and
ii A minimum of 245 hours per resident day for nurses aidesppThe rule also requires these facilities to ensure there are a sufficient number of staff with the appropriate competencies and skills set necessary to assure resident safety and to attain or maintain the highest practicable physical mental and psychosocial wellbeing of each resident to be determined based on facility assessments IdppGOP Attorneys General1 and various organizations commenced a judicial action in an attempt to invalidate the Minimum Staffing Rule under three theoriespp1 that CMS did not have statutory authority to promulgate the rulepp2 that the rule contradicts congressional intent andpp3 that the rule is arbitrary and capriciousppAs to the first cause of action asserting that CMS did not have statutory authority to promulgate the minimum staffing requirement rule the plaintiffs argue that CMS an agency created by statute promulgated the rule without Congressional authority to do so thereby violating the Administrative Procedures Act APA specifically as to the a requirement that long term care facilities have a registered nurse onsite 24 hours per day for 7 days a week and b quantitative stafftopatient ratio for long term care facilitiesppAs to the second cause of action asserting that the rule contradicts Congressional intent the plaintiffs argue that the requirement of 247 registered nurse staffing set forth in the rule rewrites the minimum staffing requirement established by Congress in addition to the scope of services performed by registered nurses Plaintiffs also assert that the quantitative stafftopatient hours per resident per day requirement is unlawful because it contradicts the qualitative statutory requirement that long term care facilities provide services sufficient to meet the nursing needs of its residentsppConcerning the third cause of action asserting that the rule is arbitrary and capricious the plaintiffs argue that by promulgating the rule CMS deviated from its past practices of adhering to the plain text of the Social Security Act permitting nursing homes to determine their staffing requirements Plaintiffs next argue that the minimum staffing requirement set forth in the rule exceeds the very minimum requirements set forth by nearly all States ignoring the State governments that had already made subjective determinations on this issue that reflect each States respective local conditions Finally the plaintiffs argue that the rule is arbitrary and capricious because it fails to consider the possibility that it is virtually impossible for LTCs to comply with the ruleppPlaintiffs are also seeking preliminary injunctive relief to maintain the staffing requirement status quo as it was prior to the promulgation of the minimum staffing requirement rule Oral argument is scheduled right around the corner on Dec 6 2024ppYet the results of the litigation may end up superseded by the Trump administrations enforcement priorities come 2025 Indeed many in the long term care industry and in related fields see the staffing standards as ripe for a downshift during President Trumps second term which may render the litigation to be a sideline activityppWhats NextppBond is closely following the dynamics in agency enforcement attendant to the forthcoming leadership change in Washington in HHS and beyond and will continue to provide updatespp1 Attorneys General of Kansas Iowa South Carolina Alabama Alaska Arkansas Florida Georgia Idaho Indiana Kentucky Missouri Montana Nebraska Oklahoma North Carolina South Dakota Utah Virginia and West Virginia LeadingAge of Kansas South Carolina Iowa Colorado Maryland Michigan Minnesota Missouri Nebraska New JerseyDelaware Ohio Oklahoma Pennsylvania Southeast Tennessee VirginiappView sourceppSee more ppDISCLAIMER Because of the generality of this update the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations
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ii A minimum of 245 hours per resident day for nurses aidesppThe rule also requires these facilities to ensure there are a sufficient number of staff with the appropriate competencies and skills set necessary to assure resident safety and to attain or maintain the highest practicable physical mental and psychosocial wellbeing of each resident to be determined based on facility assessments IdppGOP Attorneys General1 and various organizations commenced a judicial action in an attempt to invalidate the Minimum Staffing Rule under three theoriespp1 that CMS did not have statutory authority to promulgate the rulepp2 that the rule contradicts congressional intent andpp3 that the rule is arbitrary and capriciousppAs to the first cause of action asserting that CMS did not have statutory authority to promulgate the minimum staffing requirement rule the plaintiffs argue that CMS an agency created by statute promulgated the rule without Congressional authority to do so thereby violating the Administrative Procedures Act APA specifically as to the a requirement that long term care facilities have a registered nurse onsite 24 hours per day for 7 days a week and b quantitative stafftopatient ratio for long term care facilitiesppAs to the second cause of action asserting that the rule contradicts Congressional intent the plaintiffs argue that the requirement of 247 registered nurse staffing set forth in the rule rewrites the minimum staffing requirement established by Congress in addition to the scope of services performed by registered nurses Plaintiffs also assert that the quantitative stafftopatient hours per resident per day requirement is unlawful because it contradicts the qualitative statutory requirement that long term care facilities provide services sufficient to meet the nursing needs of its residentsppConcerning the third cause of action asserting that the rule is arbitrary and capricious the plaintiffs argue that by promulgating the rule CMS deviated from its past practices of adhering to the plain text of the Social Security Act permitting nursing homes to determine their staffing requirements Plaintiffs next argue that the minimum staffing requirement set forth in the rule exceeds the very minimum requirements set forth by nearly all States ignoring the State governments that had already made subjective determinations on this issue that reflect each States respective local conditions Finally the plaintiffs argue that the rule is arbitrary and capricious because it fails to consider the possibility that it is virtually impossible for LTCs to comply with the ruleppPlaintiffs are also seeking preliminary injunctive relief to maintain the staffing requirement status quo as it was prior to the promulgation of the minimum staffing requirement rule Oral argument is scheduled right around the corner on Dec 6 2024ppYet the results of the litigation may end up superseded by the Trump administrations enforcement priorities come 2025 Indeed many in the long term care industry and in related fields see the staffing standards as ripe for a downshift during President Trumps second term which may render the litigation to be a sideline activityppWhats NextppBond is closely following the dynamics in agency enforcement attendant to the forthcoming leadership change in Washington in HHS and beyond and will continue to provide updatespp1 Attorneys General of Kansas Iowa South Carolina Alabama Alaska Arkansas Florida Georgia Idaho Indiana Kentucky Missouri Montana Nebraska Oklahoma North Carolina South Dakota Utah Virginia and West Virginia LeadingAge of Kansas South Carolina Iowa Colorado Maryland Michigan Minnesota Missouri Nebraska New JerseyDelaware Ohio Oklahoma Pennsylvania Southeast Tennessee VirginiappView sourceppSee more ppDISCLAIMER Because of the generality of this update the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations
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