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Federal Regulatory Update and HIPAA Guidance on Audio-Only Telehealth

July 22, 2022

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’Neill, Connor Breza, William R. Meiselas or Labinot Alexander Berlajolli.

CMS Issues Calendar Year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule

CMS issued a Proposed Rule scheduled to be published July 29, 2022 detailing proposed policy changes for Medicare payments under the Physician Fee Schedule (PFS), and other Medicare Part B issues. The aim of the Proposed Rule is to significantly expand access to behavioral health services, Accountable Care Organizations (“ACOs”), cancer screening, and dental care, particularly in rural and underserved areas.

The proposed CY 2023 PFS conversion factor is $33.08, which amounts to a decrease of $1.53 from the CY 2022 PFS conversion factor of $34.61. Among other things related to the above mentioned areas covered by the Proposed Rule, CMS is proposing the following changes:

  • To allow licensed professional counselors, marriage and family therapists, and other types of behavioral health practitioners to provide behavioral health services under general supervision, as opposed to direct supervision
  • To pay for clinical psychologists and licensed clinical social workers to provide integrated behavioral health services as part of a patient’s primary care team
  • To bundle certain chronic pain management and treatment services into new monthly payments in order to improve patient access to team-based comprehensive chronic pain treatment
  • To cover opioid treatment and recovery services from mobile units, such as vans, to increase access for people who are homeless or live in rural areasCMS released a Press Release and a Fact Sheet in connection with the Proposed Rule.

CMS Announces Launch of Enhancing Oncology Model

In connection with President Biden’s Cancer Moonshot Initiative, the Centers for Medicare & Medicaid Services (“CMS”) has announced the launch of its Enhancing Oncology Model (“EOM”). The EOM will run for five years from July 2023 to June 2028.

Per the Fact Sheet for the EOM issued by CMS, the health equity strategy for EOM will include, among other things, the following:

  • Requiring oncology practices to screen for health-related social needs
  • Introducing data reports on expenditure and utilization patterns of their patient population to help health care professionals identify and address health disparities
  • Offering an additional payment for the provision of “Enhanced Services” to patients who are dually eligible for Medicare and Medicaid

An overarching goal of CMS for the EOM is for “participants to be incentivized to consider the whole patient and engage with them proactively, during and between appointments,” using many of the lessons learned from the previous Oncology Care Model that was tested between July 1, 2016 and June 30, 2022.

CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F) Takes Effect

CMS’s CY 2023 Medicare Advantage and Part D Final Rule (87 FR 27704) went into effect on June 28, 2022 revising the Medicare Advantage (“MA”) and Part D regulation related to marketing and communications and the criteria used to review applications for new or expanded MA and Part D plans, including changes to the following areas:

  • Compliance with MA provider network adequacy requirements
  • Quality ratings for MA and Part D plans
  • Medical loss ratio reporting
  • Special requirements during disasters or public emergencies
  • How MA organizations calculate attainment of the maximum out-of-pocket (“MOOP”) limit for Parts A and B services
  • The use of pharmacy price concessions to reduce beneficiary out-of-pocket costs for prescription drugs under Part D

CMS has issued a Fact Sheet detailing each aspect of the Rule.

HHS Issues Guidance on HIPAA and Audio-Only Telehealth

On June 13, the Department of Health and Human Services issued guidance governing how health care providers and health plans can use remote communication technologies to provide audio-only telehealth services under certain circumstances. The guidance permits covered entities to use remote communication technologies for audio-only telehealth when doing so in compliance with the HIPAA Privacy, Security and Breach Notification Rules.

The HIPAA Privacy Rule requires that covered entities apply reasonable safeguards to protect the privacy of protected health information (PHI) from impermissible uses or disclosures, including when providing telehealth services. The HIPAA Security Rule applies to electronic protected health information (ePHI), which is PHI transmitted by, or maintained in, electronic media. In the context of audio-only telehealth services, the HIPAA Security Rule applies to current electronic technologies, such as VoIP and mobile devices with cellular or internet access, but does not apply to standard telephone lines.

Additionally, under the guidance, a covered entity communicating with patients via telephone is not required to enter into a business associate agreement with a telecommunication service provider. A business associate agreement is required only when the vendor is acting as a business associate to the covered entity, such as by assuming a role in creating, receiving, or maintaining PHI on behalf of the covered entity.

Our Team

Khaled John Klele

Khaled John Klele
Partner

​Ryan M. Magee

​Ryan M. Magee
Partner

Ryan Lee O'Neill

Ryan Lee O'Neill
Partner

Labinot Alexander Berlajolli

Labinot Alexander Berlajolli
Associate

Connor Bradford Breza

Connor Bradford Breza
Associate

William R. Meiselas

William R. Meiselas
Associate

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