Guidance on Fraud and Anti-kickback Regulations from the HHS Inspector General

In response to the public health emergency, leading provider organizations and the Alliance for Connected Care expressed interest in ensuring the ability of providers to waive co-pays or provide some telehealth services at no cost — to encourage more seniors to access needed care. These waivers would normally implicate the federal anti-kickback statute, the Civil Monetary Penalty and Exclusion Law related to kickbacks, and the Civil Monetary Penalty Law’s prohibition on inducements to beneficiaries.

On March 17, the HHS Office of the Inspector General (OIG) issued a policy statement assuring providers that they could make these changes without risk of triggering the Federal anti-kickback statute, the civil monetary penalty and exclusion laws related to kickbacks, or the civil monetary penalty law prohibition on inducements to beneficiaries. In a supplemental FAQ, OIG indicated that the policy is not limited to services defined by CMS as “telehealth visits” and instead applies to a broad category of non-face-to-face services furnished through various modalities including telehealth visits, virtual check-in services, e-visits, monthly remote care management, and monthly remote patient monitoring.

On April 3, HHS OIG issued a policy statement stating that the agency will exercise its enforcement discretion not to impose administrative sanctions for certain Stark Law violations that had been waived by HHS during the public health emergency. The Physician Self-Referral Law, commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies.

Guidance for Federally Qualified Health Centers and Rural Health Clinics from the Centers for Medicare and Medicaid Services

The CARES Act added Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) to the list of eligible providers. This change allows FQHCs and RHCs to act as distant site providers allowing them to provide telehealth services for the duration of the public health emergency.

In response to the new changes, CMS posted an article for RHCs and FQHCs on expanded flexibilities during the COVID-19 public health emergency for services provided to Medicare beneficiaries.

These new flexibilities include:

  • New payment for telehealth services, including how to bill Medicare
  • Expansion of virtual communication services
  • Revision of home health agency shortage requirement for visiting nursing services
  • Consent for care management and virtual communication services
  • Accelerated/advance payments

Guidance on Telemedicine Prescribing of Controlled Substances from the Drug Enforcement Administration

While a prescription for a controlled substance issued by means of the Internet (including telemedicine) generally requires an in-person medical evaluation, the Controlled Substances Act contains certain exceptions to this requirement. One such exception occurs when the Secretary of Health and Human Services has declared a public health emergency. Traditionally, a prescribing practitioner who has previously conducted an in-person medical evaluation may issue a prescription for a controlled substance regardless of whether a public health emergency has been declared.

The Drug Enforcement Administration announced that as long as the Secretary’s designation of a public health emergency remains in effect, DEA -registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met (as defined under Section 802(54)(D):

  • The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice
  • The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system.
  • The practitioner is acting in accordance with applicable Federal and State law.

Guidance from the Food and Drug Administration (updated June 5)

Remote Patient Monitoring

On June 5, FDA issued updated guidance to expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency. In the new guidance, the agency said it will not object to limited modifications to the indications, claims, functionality, or hardware or software the devices, listed here, as long as they do not impose undue risk.

On April 23, FDA issued guidance on non-invasive fetal and maternal monitoring used to support patient monitoring during the COVID-19 pandemic. FDA indicated that increasing the availability of these devices may increase access to important prenatal data without the need for in-clinic visits and facilitate patient management while reducing the need for in-person visits. The April 23 policy creates:

  • For devices previously cleared only for use in hospitals or other health care facilities, a change to the indications or instructions regarding use in the home setting
  • Modifications to devices, including changes in hardware or software, to allow for increased remote monitoring capability
  • Modifications to devices to make the device more mobile for facilitating transfer into and out of a transportation vehicle and into a patient’s home.

Asynchronous (Store-and-Forward)

On April 23, FDA issued guidance to help increase availability and capability of imaging systems needed for diagnosis and treatment monitoring of lung disease in patients during the COVID-19 pandemic. These imaging products include medical x-ray, ultrasound, magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions. FDA states that increasing the availability of mobile and portable imaging systems may increase options to image patients inside and outside of healthcare facilities, which could help to reduce the spread of COVID-19. The April 23 policy make several changes:

  • Modifications to Indications, Technical Specifications, Functionality, Hardware, Software, and Materials of Imaging Systems
  • Modifications to Indications and Functionality of Ultrasound Imaging Systems
  • Modifications to the Indications and Functionality of Image Analysis Software
  • Validation of Changes Made to Hardware, Software, Materials, or Duration of Use
  • In addition, FDA recommends that the products described above include labeling that helps users better understand the product modifications
  • Clinical Decision Support Software for Imaging related to COVID-19 and Co-existing Conditions
  • Policy to Help Increase Availability and Minimize Supply Chain Disruptions

Guidance from the HHS Office for Civil Rights (OCR) on the Health Insurance Portability and Accountability Act (HIPAA)

HHS OCR is responsible for enforcing certain regulations issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, to protect the privacy and security of protected health information. HHS OCR recognizes that during the COVID-19 national emergency, covered health care providers subject to HIPAA Rules may seek to communicate with patients and provide telehealth services through remote communications technologies. These technologies may not comply with the requirements of the HIPAA Rules.

In response to the rapid expansion of telehealth and the need to communicate with patients, OCR issued a “Notification of Enforcement Discretion” for telehealth remote communications during the public health emergency.  It clarifies the ability of telehealth to be delivered through platforms such as Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, without risk that OCR might seek to raise HIPAA compliance concerns.

Guidance on Clinical Laboratories 

CMS issued a memo to laboratory surveyors to provide guidance on the review of pathology slides, proficiency testing, alternate collection devices, and requirements for a Clinical Laboratory Improvement Amendment (CLIA) certificate during the COVID-19 public health emergency. Recognizing the urgency of the public health emergency and the need to promote innovative uses
of technology to increase capacity and avoid exposure risks, CMS is exercising enforcement discretion to ensure pathologists may review pathology slides remotely.