On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its Calendar Year (CY) 2022 Physician Fee Schedule (“PFS”) Final Rule. In this post, we sample some key highlights from the Final Rule.
Krusheeta R. Patel
Lessons from the COVID-19 Pandemic: Planning for Disaster Preparedness and Emergency Management in Hospitals
Although the COVID-19 pandemic is still active worldwide, health care industry leaders and regulators have already begun to think about how to implement post-pandemic changes to health care delivery based on lessons learned during the global emergency of the past year and a half. We have reported on some such post-pandemic changes to the health care industry in previous blog posts. For instance, some temporary solutions to challenges presented by COVID-19 are being made permanent due to their proven efficiency or effectiveness. The expansion of telehealth is a primary example of this. We have seen the Centers for Medicare and Medicaid Services (“CMS”), as well as state governors and legislators, expand and extend certain regulatory waivers that were initially designed as temporary solutions to allow for greater access to patient care during the pandemic, but that are becoming permanent fixtures due to their usefulness in innovative patient care delivery generally.
Other post-pandemic changes to the health care delivery landscape will be borne out of sheer necessity rather than innovation.
False Claims Act Spotlight (3 of 3): Changing Landscape of the FCA in the Courts
Over the past few weeks, we have covered recent updates to the False Claims Act (“FCA”), first discussing the recent recension of the “Brand Memo” and the resulting restoration of the Department of Justice’s willingness to use sub-regulatory guidance to bring FCA enforcement actions. In our second post, we outlined S.B. 2428’s proposal to shift the burden of proving materiality to defendants, provide for discovery reimbursement, address deference standards in motions to dismiss brought by the government in qui tam complaints, and extend whistleblower anti-retaliation protections. In this final post of our three-part series, we close out our discussion of the FCA with a review of a recent Seventh Circuit decision endorsing the use of an “objective reasonableness” defense in litigation brought under the FCA. We also highlight other recent court activity affecting enforcement of the FCA.
Where Are We Now? Trends in Telehealth Utilization
Many forces have been driving the growth of telehealth over the past decade, including value-based reimbursement models, population health management trends, and technology advancements. As we have discussed in previous blog posts, the COVID-19 pandemic was the jet fuel that propelled telemedicine utilization into the stratosphere. This growth was, in large part, due to the necessity of limiting in-person contact to avoid widespread COVID-19 transmission. In fact, as COVID-19 began to spread across the United States, the Centers for Disease Control and Prevention (“CDC”) advised health care providers to offer care via telemedicine technologies wherever appropriate. However, not all of this growth in the telehealth space can be attributed to the necessity of social distancing during the pandemic; even as transmission of COVID-19 has slowed in many areas, providers continue to offer telehealth for patient care, and patients continue to utilize it.
OSHA Releases Emergency Temporary Standards to Protect Healthcare Workers from COVID-19 Infection
On June 10, 2021, the U.S. Department of Labor Occupational Safety and Health Administration (“OSHA”) announced “an emergency temporary standard to protect healthcare workers from contracting coronavirus.” The standard focuses on healthcare workers that are on the front lines of the fight against COVID-19, aiming to increase protections for those who “continue to be at high risk of contracting the [disease] . . . while they provide us with critical healthcare services.”
One Year Later: OIG Reports Describe Evolving Challenges Hospitals Have Faced in Pandemic Health Care Delivery
In a report issued by the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) on March 23, 2021 (the “2021 Report”), representatives from 320 hospitals in 45 states, the District of Columbia, and Puerto Rico were interviewed on their experiences responding to the COVID-19 pandemic. Questions were focused on the hospitals’ most difficult challenges in responding to COVID-19, strategies used by the hospitals in addressing or mitigating those challenges, and how the government could best support hospitals responding to COVID-19. This report was a follow-up to a similar OIG pulse survey released about a year ago on April 3, 2020 (the “2020 Report”), which summarized hospitals’ answers to the same questions near the start of the pandemic. The two reports, published one year apart, provide a useful snapshot into how hospital challenges have evolved in responding to the pandemic. Looking at the two reports side-by-side, we compare the challenges hospitals faced in 2020 versus the challenges they are now contending with one year later in 2021.
Federal Vaccination Tracking Raises Privacy Concerns
Although vaccine rollout began slowly in the United States, millions of people are now being vaccinated against COVID-19 per day. As individuals receive the vaccine, states have been collecting personal health data in individual immunization registries. Experts say this data collection is essential to effectively monitor vaccination progress, report adverse reactions, compare vaccine efficacy in cross sections of the population, and keep track of who needs second doses and when.
“Tele-Triage”: The COVID-19 Crisis’s Transformation of Emergency Care and Potential Post-Pandemic Opportunities
During the COVID-19 pandemic, health care providers have faced unique challenges in the delivery of health care. As COVID-19 began to spread across the United States, the CDC advised health care providers, especially in areas with widespread COVID-19 transmission, to offer care via telemedicine technologies where appropriate. As a result, although telemedicine has been emerging as an important player in the delivery of health care over the past several years, the pandemic has caused the use of and access to telemedicine to grow to an unprecedented scale. During the pandemic, telemedicine has materialized as an especially useful tool in triaging patients in emergency care settings. This “tele-triage” model provides significant opportunity for the health care industry.