COVID 19 IMPACT ON HEALTH CARE LIABILITY AND BUSINESS Presented by: - PowerPoint PPT Presentation

COVID ‐ 19 IMPACT ON HEALTH CARE LIABILITY AND BUSINESS Presented by: Mark A. Fogg Jennifer R. Lake

In the Beginning • Federal Health & Human Services March 17 th Notice of Declaration under the Public Readiness and Emergency Preparedness Act  Qualified immunity for HC professionals & entities  Applies to medical “covered countermeasures”  Protections are product ‐ oriented  Covered countermeasure patient comp fund  May be limited to COVID ‐ 19 patients only

Early Risk Management Counseling • Document alterations in care delivery due to COVID ‐ 19 to maximize liability protections (e.g. telehealth was used because…) • Still the first line of defense: What is reasonable under the circumstances at the time?

Loosening of Telehealth Rules • HHS Office of Civil Rights March 17 th Notification  Waiver of potential HIPAA penalties for good faith use of telehealth  Can use any non ‐ public facing remote communication  Applies to all patients, not Just COVID ‐ 19 • CMS Reimbursement for telehealth visits by a physician licensed in another state, Notification March 13  Created massive confusion • DEA exception on Ryan Haight Act re telehealth and controlled substances

Volunteer Immunity • Prior: Volunteer Protection Act and state statutes  Hodgepodge of federal and state Laws • New: CARES ACT Volunteer Immunity (Section 3215)  Unpaid volunteer, limited to COVID ‐ 19 patients, qualified immunity, must be within scope of practice  No liability under state or federal law, protection exists during public health emergency • Limited role of Good Samaritan statutes due to requirements of no compensation and not in a health care facility

Delay of Elective and Non ‐ Essential Surgeries and Procedures • Governors issue Executive Orders in almost all states ordering delay of electives to protect PPE • Colorado ‐ EO 2020 ‐ 009, March 23 – April 26: All hospitals, outpatient surgeries and procedure providers are directed to cease all elective and non ‐ essential surgeries and procedures

Response: Executive Orders Liability Immunity • Power to amend or modify statutes  New York: Gov amends Good Samaritan statute • Healthcare providers as state agents with state immunity protections  Michigan: HC as “Emergency Management Workers” • Crisis Standards of Care  Colorado: Governor’s Expert Emergency Epidemic Response Committee (“GEEERC”)  Adjusting best practices to best efforts

Response: Increased Flexibility in Telehealth, Licensing & Scope of Practice • Flexibility in communication modalities (audio included in telehealth definition) • Ability to obtain temporary licenses, telehealth licenses, expedited licenses, reactivate licenses • Allowing out of state licensed physicians to practice within a state • Expand scope of practice and focus on education and skill sets to allow practicing outside of traditional scope

GEEERC and Covid ‐ 19 • Crisis Standards of Care that GEEERC created for COVID ‐ 19  Emergency Medical Services  Personal Protective Equipment  Hospital, Including Crisis Triage • Chief Medical Officer of CDPHE activated EMS and PPE crisis standards of care, but not hospital crisis triage

Application of Colorado Liability Immunity for Health Care • Providers that in “good faith comply completely” with Board of Health rules and Executive Orders shall be immune from civil or criminal liability • Potential Immunity:  Delay of elective procedures mandated by Executive Order and resumption of elective procedures in compliance with CO Public Health Order 20 ‐ 29

Resumption of Elective Surgeries and Procedures • Suggested approach, resources, and special COVID ‐ 19 consent form posted on COPIC and Childs McCune websites:  Collect and retain background data that it is a safe environment to perform elective surgeries/procedures  Create a patient education communication on elective surgeries/procedures during the COVID ‐ 19 pandemic  Utilize a special consent form for electives • CDPHE amended Public Health Order 20 ‐ 29 (July 24, 2020)  PPE Reserves, adequate screening and testing, CDC recommended infection control, face masks

Key Colorado Government Links Governor Executive Orders: • State of emergency (extended to Aug. 6): https://drive.google.com/file/d/1Wpn4DIw1GzOFcA6hxzTnz 3ksFkF3lmja/view • Easing of telehealth restrictions (extended to July 27): https://drive.google.com/file/d/1f0gSxY6JlClCwpofNYCtF_W BQ_Hjbk9t/view • Opening up scope of practice restrictions (extended to July 12): https://drive.google.com/file/d/1VzMwH2ChLGczFVVZTSMqt No7GqUguN ‐ 5/view

Key Colorado Government Links Elective and non ‐ essential surgeries and procedures: • Cease and Desist Order (in effect until April 27): https://drive.google.com/file/d/15PDjUCnUpR ‐ yet99q6NbPAWh52TUWoo0/view • CDPHE Order on limited recommencement of elective surgeries and procedures (extended to July 24): https://drive.google.com/file/d/1BhAXUL0U5j0Qp9g2qPRjZaF xp4o ‐ g5Hi/view • Public Health Order on hospital data reporting for COVID ‐ 19 (in effect until Aug. 31): https://drive.google.com/file/d/1wa_ ‐ A0Y2kOZeJJkpq0ZjO7rXuA1CDv ‐ o/view

American Society of Clinical Oncology: A Guide to Cancer Care Delivery During the COVID ‐ 19 Pandemic • • • Before patient arrival Tools for HC well ‐ being Ancillary services • • Patient arrival and mental health Cancer screening • • • Patient investigation for Resources and supplies Cancer surgeries • • COVID ‐ 19 Social distancing in Clinical trials • COVID positive criteria clinical areas • for infusion services Location services/hours • COVID diagnostic of operation • testing Surge planning • • Pre ‐ screening of Sanitation protocols • asymptomatic patients Support services • with cancer Patient health and https://www.asco.org/site • Testing policies for HC safety education s/new ‐ • personnel Telemedicine www.asco.org/files/conte • • PPE Medical oncology nt ‐ files/2020 ‐ ASCO ‐ Guide ‐ • • Screening of work force Radiation oncology Cancer ‐ COVID19.pdf

COVID ‐ 19: Future HC COVID ‐ 19 Cases? • National Plaintiff Firms – Large population centers  Inadequate infection control  Inadequate supplies  Nursing homes • Licensing Cases  Kansas Board statement that COVID ‐ 19 issues are mitigating factors

CARES Act • Coronavirus Aid, Relief, and Economic Security Act  Created the HHS Provider Relief Fund  Gave Secretary of HHS broad waiver authority with respect to Medicare rules and restrictions  Created a variety of business assistance programs

HHS Provider Relief Fund • $50 billion allocated to hospitals and physician practices:  Initial $30 billion distributed based on share of Medicare fee ‐ for ‐ service reimbursements in 2019  Additional $20 billion distributed based on net patient revenue • Upon receipt of funds, providers must sign terms and conditions • Must document use of funds

HHS Provider Relief Fund • Targeted distributions available for:  Treatment of uninsured COVID ‐ 19 patients  Participants in state Medicaid program  Must submit revenue information to HHS by July 20

CARES Act Reimbursement Provisions • High deductible plan can still qualify as high deductible even if no deductible is charged for telehealth services • Broad range of changes to Medicare policies • CMS waived requirement that hospitalized Medicare patients be under the care of a physician • CMS waived requirements to allow physicians whose privileges will expire and new physicians to be able to practice at hospital before full review and approval

Medicare Telehealth Changes • Wide variety of services can be provided by telehealth and by audio ‐ only communication  Emergency visits  Outpatient therapy and educational services  Radiation treatment management services • Hospitals can receive payment for originating site facility fee when practitioner that ordinarily practices in outpatient department provides telehealth services to a patient at their home

Colorado Return ‐ to ‐ Work Guidance • Colorado Public Health Order 20 ‐ 29 – must have a plan to implement • Follow CDC infection control policies • Universal symptom screening process • Non ‐ medical personnel must wear masks in medical facilities • If masks are removed (e.g. breaks), staff must remain six feet apart from each other • Reassess operations every 2 weeks

Colorado Return ‐ to ‐ Work Guidance • If employee reports symptoms, must be sent home immediately • Employee must stay home until: (a) 10 days have passed since first symptoms and (b) fever ‐ free and no medication for 72 hours  https://www.cdc.gov/coronavirus/2019 ‐ ncov/hcp/guidance ‐ risk ‐ assesment ‐ hcp.html • Must contact health department if multiple employees exhibit symptoms

Sample ASCO Guidance • Reduce number of staff by allowing telework for scheduling, billing, and phone ‐ based staff • Identify separate staff for care of COVID ‐ 19 ‐ positive patients • Modify duties for staff with increased vulnerability • Provide training on infection control and cleaning • Encourage employees to avoid non ‐ essential personal travel • Offer support and stress management resources