Clinical Research – Government and Industry Team to Provide Hope in the Crisis

Necessity is the mother of invention, and it’s hard to remember a time when humanity has been more motivated to resolve a crisis. Times like this, though, generally bring out the best in all of us – the best in government, the best in industry, and the best in individuals. The COVID-19 research and development response by all partners is helping provide hope during these difficult times. A few of these promising developments are as follows:

Convalescent Plasma Research – researchers and health care providers looking to COVID-19 survivors’ blood plasma for a possible therapy in the fight against the virus. The FDA is allowing emergency Investigational New Drug applications for serious or life-threatening COVID-19 infections. The FDA recently published guidance to researchers on COVID-19 Convalescent Plasma. Continue reading

HIPAA – COVID-19 Update

HIPAA – Waiver of security and privacy rules relating to telehealth – OCR has announced that it will not penalize health care providers that serve patients through everyday communications technologies during the COVID-19 nationwide public health emergency. This applies to widely available communications apps, such as FaceTime or Skype, when used in good faith for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to COVID-19. The waiver covers security issues, BAA requirements with the video communication vendors, and other noncompliance issues that relate “to the good faith provision of telehealth services during the COVID-19 nationwide public health emergency.” Continue reading

Managed Care: LA Department of Insurance Emergency Rule 37

The Louisiana Department of Insurance (LDI) issued Emergency Rule 37, a package of regulations to address COVID-19 issues. The regulation applies to all HMOs, MCOs, PPOs, TPAs, PBMs and all other entities licensed by the LDI. It provides for the following:

For geographic accessibility requirements, the LDI waives plan’s obligations to comply with those requirements except for:

  1. Emergency services
  2. Services related to the testing or treatment of COVID-19, and
  3. Services that have not been ordered postponed by Healthcare Facility Notice #2020-COVID19-ALL-006 on March 18, 2020, and
  4. Services ancillary to any of the above.

Continue reading

TELEHEALTH – COVID-19 Updates

The COVID-19 pandemic has created opportunities for the growth of telemedicine to address patient care needs and the removal of a number of roadblocks. Here is a list of the waivers and orders put into place to ease some of the requirements associated with telehealth services.

The Louisiana Telehealth Access Act defines telehealth as “a mode of delivering healthcare services that utilize information and communication technologies to enable the diagnosis, consultation, treatment, education, care management, and self-management of patients at a distance from healthcare providers. Telehealth allows services to be accessed when providers are in a distant site and patients are in the originating site. Telehealth facilitates patient self-management and caregiver support for patients and includes synchronous interactions and asynchronous store and forward transfers.” La. R.S. 40:1222.3(6). “Synchronous interaction” means communication through interactive technology that enables a healthcare provider and a patient at two locations separated by distance to interact via two-way video and audio transmissions simultaneously. La. R.S. 40:1222.3(5). A “healthcare provider may utilize interactive audio without the requirement of video if, after access and review of the patient’s medical records, the provider determines that he is able to meet the same standard of care as if the healthcare services were provided in person.”

CMS Broadens Access to Telehealth during COVID-19 Pandemic:

CMS has broadened access to telehealth services for Medicare beneficiaries during the COVID-19 health emergency. CMS has announced several waivers which implement the following:

  • Waiver of the originating site and geographic site restrictions on Medicare telehealth services, allowing delivery of telehealth services in all areas of the country and location, including the patients home
  • Providers may now use telehealth services for diagnosis and treatment for new and established patients for COIVD-19, as well as conditions unrelated to the health crisis.
  • Providers may now use communication platforms, such as Skype or FaceTime, to provide telehealth services during the COVID-19 pandemic, and not be subject to HIPAA penalties.

CMS has broadened such access to care and telehealth services so that Medicaid beneficiaries can receive a wider range of services without having to travel to see a provider.

https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet;

https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf.

State of Louisiana Health Care Facility Notice Order #2020-COVID-19-ALL-007:

The Louisiana Department of Health has issued a new order directing and requiring all licensed healthcare facilities in Louisiana to transition into delivering medical services via telehealth when medically appropriate. Such services can only be provided through a telehealth mode when the same standard of care can be met as an in-person visit.

http://ldh.la.gov/assets/oph/Coronavirus/resources/providers/LDH-UPDATED-Notice-Med-Surg-Procedures32120.pdf

Louisiana Medicaid Provider Update:

Louisiana Medicaid published provider guidance encouraging the use of telemedicine/telehealth services, when appropriate, to decrease the amount of in person visits. If a provider does not have a synchronous audio/video system, such as FaceTime or Skype, a provider can use audio only (telephone) without the requirement of video to provide telehealth services, as long as the same standard of care is met and the need for the audio only must be documented in the patient record. Medicaid does not have a limitation on the originating site as to where such services can be provided. If a provider does not have a HIPAA compliant platform, they may use everyday communication platforms during the COVID-19 emergency.

http://ldh.la.gov/assets/medicaid/COVID-19/COVID-19.Provider.Update3.17.2020.pdf

Stay tuned! Telehealth services will continue to be the “standard of care” used during the pandemic and we expected to see more regulatory movement to facilitate the provision of these services.

Written By: Judith W. Giorlando & Christine M. Colwell

Gross Negligence or Willful Misconduct Must Be Shown to Establish Liability Against Health Care Providers in Louisiana During a Declared Public Health Emergency

The Louisiana Department of Insurance (LDI) issued Emergency Rule 37, a package of regulations to address COVID-19 issues. The regulation applies to all HMOs, MCOs, PPOs, TPAs, PBMs and all other entities licensed by the LDI. It provides for the following:

For geographic accessibility requirements, the LDI waives plan’s obligations to comply with those requirements except for:

  1. Emergency services
  2. Services related to the testing or treatment of COVID-19, and
  3. Services that have not been ordered postponed by Healthcare Facility Notice #2020-COVID19-ALL-006 on March 18, 2020, and
  4. Services ancillary to any of the above.

Continue reading