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FTC Issues Policy Statement Expanding Interpretation of Health Breach Notification Rule’s Scope

On September 15, 2021, the Federal Trade Commission (FTC) voted 3–2 along party lines (with Republican commissioners dissenting) to issue a policy statement announcing an expansive interpretation of the FTC’s Health Breach Notification Rule, 16 CFR Part 318 (the Rule). According to the policy statement, the Rule applies to health apps and connected devices that are not subject to the Health Insurance Portability and Accountability Act (HIPAA) but are capable of drawing information from multiple sources—for example, through a combination of consumer inputs and application programming interfaces (APIs).

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Vaccine Requirements in the Workplace

As more and more private and public companies require vaccinations, employees are finding it increasingly difficult to avoid these mandates. In this BBC Radio 5 Live interview, McDermott Partner Michelle Strowhiro noted that US employers have a right to mandate vaccination for any employee that is in an employer’s office.

“As such, if an employee is violating that policy and is coming into an office unvaccinated, an employer can take action and terminate that employee,” Strowhiro said.

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50-State Survey | Rules Governing Telehealth Modalities and Patient-Provider Relationships

Telehealth’s state-by-state regulatory patchwork means that healthcare providers must navigate a variety of regulations that govern which types of care can be provided by virtual means, and even what modalities can be used in different care settings. McDermott’s recent 50-state survey explores the standard and requirements that physicians and nurse practitioners must follow when prescribing non-controlled substances or ordering tests via a telemedicine encounter. Key issues addressed in the survey include:

  • In what states are asynchronous solutions permitted?
  • What are state rules governing prescriptions when a physician-patient relationship does not exist prior to the telehealth encounter?
  • What are state rules on prescribing via audio-visual encounters or audio-only encounters?
  • Under what state regulations can a questionnaire be sufficient to create a physician-patient or advance practice registered nurse-patient relationship?

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CMS Proposes Heightened Penalties and Additional Requirements Under the Hospital Price Transparency Rule

On July 19, 2021, US President Joe Biden’s administration released a proposed rule that would increase penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1, 2022. According to McDermott’s Emily Jane Cook and Steven J. Schnelle, the proposed rule also provides certain potentially burdensome clarifications and requests comment on further rulemaking activity relating to the Hospital Price Transparency Rule.

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Just How Many Employers Will Mandate Vaccines?

An August Willis Towers Watson poll found that 52% of 961 surveyed companies intend to implement at least one vaccine mandate by 2021’s fourth quarter. In a poll in May, 72% of respondents said they had no plans to require vaccines.

To encourage vaccination, some employers—like Delta Air Lines—are introducing or considering company healthcare plan surcharges for unvaccinated employees. However, in this article published via Advisory Board, McDermott Partner Judith Wethall said few employers have actually “pulled the trigger” on such a move.

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Protecting the Telehealth Consumer: FTC and State-Based Considerations

Telemedicine in the United States is facing an important crossroads. While telehealth services have demonstrated their value as an integral part of care delivery, federal and state waivers instituted during the COVID-19 pandemic are likely to expire soon. As lawmakers and agency officials consider updated or expanded digital health rules, regulators are expected to intensify their scrutiny of providers.

In this webinar, McDermott partners Jiayan Chen and Brian J. Boyle explore consumer protections for telehealth consumers, including the following:

  • Privacy considerations beyond the Health Insurance Portability and Accountability Act of 1996, including Federal Trade Commission requirements;
  • How to prepare for the Health Breach Notification Rule;
  • The ins and outs of advertising telehealth, including claims, endorsements and social media;
  • Strategies for engaging with users in the digital environment; and
  • Increased fraud enforcement.

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Red Tape, Legal Risk Douse Fervor for Surcharges on Unvaccinated

Companies curious about a major airline’s unvaccinated healthcare premium surcharge are discovering that it may be too complex to copy. The airline recently announced that unvaccinated employees enrolled in the company’s health plan would see a $200 monthly surcharge. In this Bloomberg Law article, McDermott Partner Judith Wethall said the compliance hurdles are “tricky and kind of dilute the message.”

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CMS Addresses Virtual Care Expansion in CY 2022 Medicare Physician Fee Schedule Proposal

The Centers for Medicare & Medicaid Services recently published its annual proposed changes to the Medicare Physician Fee Schedule, which include several key telehealth and other virtual care-related proposals. The proposals address long-standing restrictions that have historically limited the use of telehealth and virtual care, including geographic and originating site restrictions, and limitations on audio-only care, as well as coverage extensions for some services added during the COVID-19 public health emergency.

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Leniency on Implementation Timetables for Surprise Billing and Insurer Price Transparency

The Biden administration is giving insurers more time to follow the insurer price transparency rule and the ban on surprise billing. Federal regulators will delay enforcement of machine-readable file provider rates until July 1, rather than the start of 2022. In this article published in Modern Healthcare, McDermott Partner Kate McDonald noted that the initial timeline was “very aggressive.”

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Companies Eye Financial Penalties for Unvaccinated Workers

As companies consider whether or not to introduce vaccine mandates for employees, there is interest among some employers to increase health care premiums or impose financial penalties on employees who refuse vaccination. One major airline, for example, recently announced that unvaccinated employees enrolled in the company’s health plan would see a $200 monthly surcharge. However, according to McDermott Partner Judith Wethall in The Hill, financial penalties for the unvaccinated are legally complicated, and vaccine mandates likely pose less regulatory issues for employers to impose.

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