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The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently issued new guidance (Guidance) on the use of remote communication technologies to deliver audio-only telehealth in accordance with HIPAA. Per OCR, the Guidance is intended to ensure continued access for patients to audio-only telehealth in a secure and compliant manner, particularly once OCR’s notification of enforcement discretion (previously discussed here) tied to the COVID-19 pandemic is rescinded (i.e., once the HHS-declared COVID-19 public health emergency is ended).…

Continue Reading HHS Issues HIPAA Guidance to Support Audio-Only Telehealth Services

Certain COVID-19 emergency declaration blanket waivers are being phased out by the federal government, and health care providers should take steps to determine whether current arrangements are compliant. As background, in response to the COVID-19 public health emergency CMS previously enacted extensive temporary COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers. However, the Centers for Medicare and Medicaid Services (CMS) have now determined that various regulatory requirements must be restored in order to protect the health and safety of residents in long-term care facilities.…

Continue Reading NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD Facilities

On April 27, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-08 (Advisory Opinion) in which it declined to impose sanctions against a federally qualified health center (Requestor) for an arrangement involving the loaning of smartphones to patients to allow those patients to receive telehealth services from the Requestor. The OIG concluded that although the arrangement would constitute prohibited remuneration under the Federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Monetary Penalties Law (CMP), the limited scope of the arrangement and the safeguards in place did not warrant the imposition of sanctions.
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Continue Reading Advisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth Services

OSHA has partially reopened the rulemaking record and scheduled an informal public hearing to seek comments on several topics relating to the development of a final standard to protect healthcare and healthcare support service workers from workplace exposure to COVID-19. In June of last year, OSHA issued an Emergency Temporary Standard (ETS) to protect workers in healthcare settings from occupational exposure to the virus. This ETS also served as a proposed rule and focused on healthcare workers most likely to have contact with people infected with the virus.
Continue Reading OSHA Taking Comments on Proposed Permanent Healthcare COVID-19 Standard

The federal Office of Inspector General (OIG) recently published a report (OIG Report) as part of a series of analyses of the expansion and utilization of telehealth in response to the COVID-19 public health emergency.  In its report, the OIG concludes that telehealth was “critical for providing services to Medicare beneficiaries during the first year of the pandemic” and that the utilization of telehealth “demonstrates the long-term potential of telehealth to increase access to health care for beneficiaries.” The OIG’s conclusions are notable because they come at a time when policymakers and health care stakeholders are determining whether and how to make permanent certain expansions of telehealth for patients nationwide.
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Continue Reading OIG: Telehealth “Critical” to Maintaining Access to Care Amidst COVID-19

On March 8, 2022, OSHA released an enforcement memorandum detailing a new initiative involving a short-term increase in highly focused inspections directed at hospitals and skilled nursing care facilities that treat or handle COVID-19 patients. The goal of this initiative is to ensure continued mitigation to control the spread of COVID-19 and future variants of the SARS-CoV-2 virus and protect the health and safety of healthcare workers who are at heightened risk for contracting the virus. This short-term initiative is a supplement to OSHA’s targeted enforcement under the COVID-19 National Emphasis Program (NEP), focusing on follow-up and monitoring inspections of hospitals and skilled nursing care facilities previously inspected or investigated by OSHA. It is also coming as yet-to-be released proposed permanent OSHA regulations to protect health-care workers from COVID-19 are under review at the White House’s Office of Information and Regulatory Affairs, which is typically one of the last steps before regulations are enacted.
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Continue Reading OSHA Announces COVID-19 Enforcement Initiative for Hospitals and Nursing Care Facilities

Effective February 3, 2022, the Massachusetts Board of Registration in Medicine (BoRM), which oversees physician licensure and the practice of medicine, updated its “Policy on Telemedicine in the Commonwealth” (Policy) to provide more guidance for licensed physicians on utilization of telemedicine in practice. BoRM initially issued this Policy in 2020 in connection with the onset of COVID-19 and the significant corresponding expansion of telemedicine and other telehealth care delivery models for patients and providers.
Continue Reading Massachusetts Updates State Telemedicine Guidance for Physicians

In a February 14, 2022, press release, The Joint Commission (Joint Commission) announced that it began surveying affected facilities for compliance with the Centers for Medicare and Medicaid Services (CMS) interim final rule entitled “Omnibus COVID-19 Health Care Staff Vaccination,” published on November 5, 2021, with guidance following on December 28, 2021 (see our previous analysis here and here). Among other things, the rule required eligible staff in affected facilities to be vaccinated against COVID-19. Joint Commission surveying began on January 27, 2022, in states that did not challenge CMS’s interim final rule, and the Joint Commission will begin surveying the remaining states (except Texas) on February 14, 2022. It is not clear when surveys will begin in Texas, as the deadlines for compliance with the interim final rule differ from the other 49 states.
Continue Reading The Joint Commission Announces COVID-19 Vaccine Surveys Have Begun

The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic. Below is an overview of these actions and related COVID-19 vaccine information:

Full Approval of the Moderna COVID-19 Vaccine for 18+

On January 31, 2022, the FDA announced its full approval (licensing) of the Moderna COVID-19 Vaccine for individuals 18 and older. The Moderna vaccine had been administered under an Emergency Use Authorization (EUA) from the FDA since December 18, 2020.  This is the second COVID-19 vaccine to be approved by the FDA following approval of Pfizer-BioNTech’s COVID-19 vaccine on August 23, 2021. Notably, the approved Moderna COVID-19 vaccine will be marketed and known as the ‘Spikevax.’…

Continue Reading COVID-19 Vaccine Update – February 2022

In a per curiam decision issued January 13, 2022, the U.S. Supreme Court upheld the federal health care worker vaccine mandate rule, finding that the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid Services was authorized by law to issue the rule.  See our previous analyses of the rule and subsequent litigation here and here for more background information on the stakes of this case.
Continue Reading U.S. Supreme Court Upholds Health Care Worker Vaccine Mandate