HIPAA Telehealth Waiver: HHS Office for Civil Rights (OCR) will exercise enforcement discretion and waive penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype, during the COVID-19 nationwide public health emergency: https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/index.html

 

IRS High Deductible Waiver: IRS issued guidance 2020-15 allows for testing and treatment of COVID-19 to be covered by high deductible health plans (HDHPs) prior to satisfaction of the plan's minimum deductible without making an induvial ineligible for an HSA/HDHP plan (current law).

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Interoperability/Information Blocking Rules: No decisions have been made but CMS officials hinted at the at a Health IT Advisory Committee meeting that the administration is considering a push-back the timeline for payers, providers and health IT vendors to come into compliance with its two sweeping rules to promote interoperability as the healthcare system struggles with the novel coronavirus outbreak.

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CMS Telehealth Actions: CMS announced waivers and policy changes March 17 to broaden access to telehealth services for Medicare beneficiaries during the COVID-19 public health emergency. See CMS frequently asked questions document about the changes included in its announcement. These were both in compliance with H.R. 6704 and by existing authority They include:

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• Waivers of originating and geographic site restrictions on Medicare telehealth services, permitting the delivery of these services in all areas of the country and all locations, including patients' homes.

• The ability of providers to use expanded telehealth authority for new and established patients for diagnosis and treatment of COVID-19, as well as for conditions unrelated to the pandemic.

• Permission for providers to use everyday communications technologies, such as FaceTime or Skype, during the COVID-19 public health emergency, without running afoul of HIPAA penalties.

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CMS Coding Guidance on E-VISITS:  In all types of locations including the patient’s home, and in all areas (not just rural), established Medicare patients may have non-face-to-face patient-initiated communications with their doctors without going to the doctor’s office by using online patient portals. These services can only be reported when the billing practice has an established relationship with the patient. For these E-Visits, the patient must generate the initial inquiry and communications can occur over a 7-day period. The services may be billed using CPT codes 99421-99423 and HCPCS codes G2061-G2063, as applicable. The patient must verbally consent to receive virtual check-in services. The Medicare coinsurance and deductible would apply to these services.

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Medicare Part B also pays for E-visits or patient-initiated online evaluation and management conducted via a patient portal. Practitioners who may independently bill Medicare for evaluation and management visits (for instance, physicians and nurse practitioners) can bill the following codes:

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• 99421: Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5–10 minutes

• 99422: Online digital evaluation and management service, for an established patient, for up to 7 days cumulative time during the 7 days; 11– 20 minutes

• 99423: Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 21 or more minutes.

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Clinicians who may not independently bill for evaluation and management visits (for example – physical therapists, occupational therapists, speech language pathologists, clinical psychologists) can also provide these e-visits and bill the following codes:

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• G2061: Qualified non-physician healthcare professional online assessment and management, for an established patient, for up to seven days, cumulative time during the 7 days; 5–10 minutes

•  G2062: Qualified non-physician healthcare professional online assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 11–20 minutes

• G2063: Qualified non-physician qualified healthcare professional assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 21 or more minutes.

 

1135 Waivers – A subject of much confusion: With the President’s proclamation of a public health emergency (PHE) Secretary Azar announced March 13 that states could apply for an 1135 waiver (under Medicaid).  Examples of waivers available under section 1135 of the Act include:

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• Temporarily suspend prior authorization requirements;

• Extend existing authorizations for services through the end of the public health emergency;

• Modify certain timeline requirements for state fair hearings and appeals;

• Relax provider enrollment requirements to allow states to more quickly enroll out-of-state or other new providers to expand access to care, and

• Relax public notice and submission deadlines for certain COVID-19 focused Medicaid state plan amendments, enabling states to make changes faster and ensure they can be retroactive to the beginning of the emergency.

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Constitutional lawyers agree they do not have the authority to waive state licensure laws.  Each 1135 waiver must be applied for and be approved by CMS.  FL, WA, CO and several others have.  CMS has of approved wiavers here.  But, each state must act independently.  HHS Secretary Alex Azar sent a letter March 24 to the nation's governors asking them to “ensure health professionals maximize their scopes of practice and are able to travel across state lines or provide telemedicine to communities where they are needed most."  The Federation of State Boards of Medicince keeps a running list of state’s licenseure requirements here, with information about changes due COVID-19.

 

 

Under 1135 waiver authority, the Secretary may allow the following requirements may be waived or modified:

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• certain conditions of participation certification requirements, program participation or  similar requirements for individual health care providers or types of health care providers;

• pre-approval requirements;  

• requirements that physicians and other health care professionals hold licenses in the State in which they provide services if they have a license from another State (and are not affirmatively barred from practice in that State or any State in the emergency area) for purposes of Medicare, Medicaid, and CHIP reimbursement only;

• sanctions under the Emergency Medical Treatment and Active Labor Act (EMTALA) for redirection or reallocation of an individual to another location to receive a medical screening  pursuant to an appropriate state emergency preparedness plan or a state preparedness plan for the transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared Federal public health emergency.  A waiver of EMTALA sanctions is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay;

• sanctions under section 1877(g) (Stark) relating to limitations on physician referral under such conditions and in such circumstances as the Centers for Medicare & Medicaid determines appropriate;

• deadlines and time tables for performance of required activities to allow  timing of such deadlines to be modified;

• limitations on payments for healthcare items and services to permit Medicare Advantage Plan enrollees to use out-of-network providers in an emergency situation.  To the extent possible, the Secretary must reconcile payments so that enrollees do not pay additional charges and so that the plan pays for services included in the capitation payment;

• sanctions and penalties arising from noncompliance with HIPAA privacy regulations relating to: a) obtaining a patient’s agreement to speak with family members or friends or honoring a patient’s request to opt out of the facility directory, b) distributing a notice of privacy practices, or c) the patient’s right to request privacy restrictions or confidential communications.  The waiver of HIPAA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay.

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FDA - Limited easing enforcement: on labeling claims clinical decision support software. 

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