COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released

March 24, 2020

Today, the Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) released two comprehensive toolkits on telehealth:

  • The Telehealth Toolkit for General Practitioners available here;
  • The End-Stage Renal Disease Providers Toolkit available here.
  • The Toolkits’ release follows up on last week’s Centers for Medicare & Medicare Services (“CMS”) loosening of requirements for Medicare coverage of telehealth services and privacy and data security requirements so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act.
  • COVID-19 Emergency TeleHealth Waivers
  • Under this new waiver, Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patient’s places of residence starting March 6, 2020. 
  • A range of providers, such as doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers, will be able to offer telehealth to their patients.
  • New TeleHealth Toolkits
  • Each of the telehealth toolkits released today contains electronic links to reliable sources of information on telehealth and telemedicine, which will reduce the amount of time providers spend searching for answers and increase their time with patients. Many of these links will help providers choose learn about the general concept of telehealth, choose telemedicine vendors, initiate a telemedicine program, monitor patients remotely, and develop documentation tools. Additionally, the information contained within each toolkit will also outline temporary virtual services that could be used to treat patients during this specific period of time.

    • COVID-19 Limited HIPAA Privacy Telehealth Relief
  • Previously last week, HHS Office for Civil Rights (OCR) announced relief providing covered health care providers subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security and Breach Notification Rules greater latitude for communicating with patients, and providing telehealth services, through remote communications technologies during the COVID-19 national emergency, OCR also published a bulletin advising covered entities of further flexibilities available to them as well as obligations that remain in effect under HIPAA as they respond to crises or emergencies available here.
  • According to the OCR Notice, a covered health care provider that wants to use audio or video communication technology to provide telehealth to patients during the COVID-19 nationwide public health emergency can use any non-public facing remote communication product that is available to communicate with patients. OCR is exercising its enforcement discretion to not impose penalties for noncompliance with the HIPAA Rules in connection with the good faith provision of telehealth using such non-public facing audio or video communication products during the COVID-19 nationwide public health emergency. This exercise of discretion applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19.

    The OCR Notice temporarily allows HIPAA-covered health care providers to use some, but not all popular applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA Rules related to the good faith provision of telehealth during the COVID-19 nationwide public health emergency. This relief, for example, allows a health care provider during the COVID-19 emergency in the exercise of his or her professional judgement to request to examine a patient using a video chat application connecting the provider’s or patient’s phone or desktop computer in order to assess a greater number of patients while limiting the risk of infection of other persons who would be exposed from an in-person consultation.

    Under this Notice, however, Facebook Live, Twitch, TikTok, and similar video communication applications are considered “public facing,” which OCR says health care providers should not use in the provision of telehealth.

    The Notice encourages health care providers to notify patients that these third-party applications potentially introduce privacy risks, and providers should enable all available encryption and privacy modes when using such applications.

    Covered health care providers that seek additional privacy protections for telehealth while using video communication products should provide such services through technology vendors that are HIPAA compliant and will enter into HIPAA business associate agreements (BAAs) in connection with the provision of their video communication products. The Notice states that some vendors that represent to OCR that they provide HIPAA-compliant video communication products and that they will enter into a HIPAA BAA include:

    • Skype for Business
    • Updox
    • VSee
    • Zoom for Healthcare
    • Google G Suite Hangouts Meet

    However the Notice also states OCR has not reviewed the BAAs offered by these vendors, and this list does not constitute an endorsement, certification, or recommendation of specific technology, software, applications, or products. There may be other technology vendors that offer HIPAA-compliant video communication products that will enter into a HIPAA BAA with a covered entity. Further, OCR does not endorse any of the applications that allow for video chats listed above.

    Under this Notice, however, OCR will not impose penalties against covered health care providers for the lack of a BAA with video communication vendors or any other noncompliance with the HIPAA Rules that relates to the good faith provision of telehealth services during the COVID-19 nationwide public health emergency.

    Guidance on BAAs, including sample BAA provisions, is available here. Additional information about HIPAA Security Rule safeguards is available here.

    Beyond the Notice, has technical assistance on telehealth here.

    CMS continues to monitor the developing COVID-19 situation and assess options to bring relief to clinicians. To keep up with the important work the Task Force is doing in response to COVID-19 click here For complete and updated information specific to CMS, please visit the Current Emergencies Website.

    More Information

    We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.  

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    Trump Administration Grants Fiduciary Rule Prohibited Transaction Relief

    March 27, 2017

    Employer and other employee benefit plan sponsors, fiduciaries and investment and financial service providers and other plan service providers should review their plans for possible transactions that may qualify for excise tax relief under new guidance issued today by the Internal Revenue Service and Department of Labor.

    IRS Announcement 2017-04, scheduled for publication in the Federal Register as  IRB 2017-16 on April 17, 2017, provides relief from the excise taxes under section 4975 of the Internal Revenue Code and any related reporting requirements  to conform to the temporary enforcement policy described by the Department of Labor (DOL) in Field Assistance Bulletin (FAB) 2017-01 with respect to the final fiduciary duty rule published in the Federal Register on April 8, 2016 (81 F.R. 20946), entitled “Definition of the Term ‘Fiduciary’; Conflict of Interest Rule – Retirement Investment Advice” and related prohibited transaction exemptions, including the Best Interest Contract Exemption (BIC Exemption), the Class Exemption for Principal Transactions in Certain Assets Between Investment Advice Fiduciaries and Employee Benefit Plans and IRAs (Principal Transactions Exemption), and certain amended prohibited transaction exemptions (collectively, PTEs)

    The relief parallels similar relief provided by the Department of Labor to these individuals in a recently released Field Assistance Bulletin.

    The new DOL and IRS guidance gives temporary relief to the DOL final regulation defining who is a “fiduciary” of an employee benefit plan under § 3(21)(A)(ii) of ERISA as a result of giving investment advice to a plan or its participants or beneficiaries published April 6, 2016.  That final rule, which also applies to the definition of a “fiduciary” of a plan under § 4975(e)(3)(B) of the Code, treats persons who provide investment advice or recommendations for a fee or other compensation with respect to assets of a plan as fiduciaries in a wider array of advice relationships than was true of the prior regulatory definition.   Concurrent with its publication of the final rule, the DOL published the PTEs, which provide two new administrative class exemptions from the prohibited transaction provisions of ERISA and the Code, as well as amendments to previously granted exemptions. 

    The PTEs would allow, subject to appropriate safeguards, certain broker-dealers, insurance agents, and others that act as investment advice fiduciaries, as defined under the final rule, to continue to receive a variety of forms of compensation that would otherwise violate prohibited transaction rules, triggering excise taxes and civil liability.

    The final fiduciary duty rule became effective on June 7, 2016, and has an applicability date of April 10, 2017. The PTEs also have an applicability date of April 10, 2017, with a phased implementation period ending on January 1, 2018, for the BIC Exemption and the Principal Transactions Exemption. 

    President Trump, by Memorandum to the Secretary of Labor dated February 3, 2017, directed the DOL to examine whether the fiduciary duty rule may adversely affect the ability of Americans to gain access to retirement information and financial advice and to prepare an updated economic and legal analysis concerning the likely impact of the rule as part of that examination.

    After requesting comments on the final rule on March 3, DOL on March 10, 2017,  announced a temporary enforcement policy related to its proposal to extend for 60 days the applicability date of the fiduciary duty rule and the related PTEs. The policy announced in FAB 2017-01 provides  that:

    • If DOL issues a final rule after April 10 implementing a delay in the applicability date of the fiduciary duty rule and related PTEs, the DOL will not initiate an enforcement action because an adviser or financial institution did not satisfy conditions of the rule or the PTEs during the “gap” period in which the rule becomes applicable before a delay is implemented, including a failure to provide retirement investors with disclosures or other documents intended to comply with provisions of the rule or the related PTEs. 
    • If DOL decides not to issue a delay in the fiduciary duty rule and related PTEs, the DOL will not initiate an enforcement action because an adviser or financial institution, as of the April 10 applicability date of the rule, failed to satisfy conditions of the rule or the PTEs, provided that the adviser or financial institution satisfies the applicable conditions of the rule or PTEs, including sending out required disclosures or other documents to retirement investors, within a reasonable period after the publication of a decision not to delay the April 10 applicability date.

    Field Assistance Bulletin 2017-01 provides that, to the extent circumstances
    surrounding its decision on the proposed delay of the April 10 applicability date give rise to the need for other temporary relief, including retroactive prohibited transaction relief, the DOL will consider taking such additional steps as necessary with respect to the arrangements and transactions covered by the DOL temporary enforcement policy and any subsequent related DOL enforcement guidance. Following the issuance of the FAB, stakeholders have raised concerns about the potential application of excise taxes under Code § 4975 and related reporting obligations in cases covered by the DOL’s temporary enforcement policy. 

    Because the Code and ERISA contemplate consistency in the enforcement of the prohibited transaction rules by the IRS and the DOL, the Treasury Department and the IRS determined it appropriate to adopt a corresponding temporary excise tax non-applicability policy that conforms with the DOL’s temporary enforcement policy described in FAB 2017-01. Accordingly, ,Because the Code and ERISA contemplate consistency in the enforcement of the prohibited transaction rules by the IRS and the DOL, as further reflected in and facilitated by the statutory Reorganization Plan, the Treasury Department and the IRS have determined that it is appropriate to adopt a temporary excise tax non-applicability policy that conforms with the DOL’s temporary enforcement policy described in FAB 2017-01. Accordingly, Announcement 2017-04 provides that the IRS will not apply § 4975 and related reporting obligations with respect to any transaction or agreement to which the DOL’s temporary enforcement policy, or other subsequent related enforcement guidance, would apply. 

    The new collective guidance provides a short reprieve from the obligation to comply with the otherwise applicable of the fiduciary rule pending the new administration to review and reconsideration of that rule. How many will welcome this relief, plan sponsors, fiduciaries and service providers need to keep in mind that it’s provisions are temporary in nature and do not preclude a participant or beneficiary from seeking to establish liability of an individual providing advice or assistance with respect to services under the facts and circumstances in an ERISA lawsuit.  Because of the risk of litigation even when the agencies are standing down from enforcement, plan sponsors and fiduciaries and the service providers that assist them with reviewing and making investmentat all times should take care to be able to defend their actions under the fiduciary rules. 

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