The spread of COVID-19 across the world brought unprecedented challenges to the US healthcare system. The strain on resources, the pressure on frontline workers and the financial risks to provider organizations demanded wide-scale changes take place at a rapid pace. In response, state and federal health regulation roll-backs were announced almost weekly, all with the goal of improving safety and access to care. These roll-backs included:
- On March 20th, the Food and Drug Administration (FDA) issued updated regulations for digital remote monitoring equipment. This change was designed to address the struggles some healthcare organizations faced in integrating electronic health records with their software packages. The FDA hoped to expand both the availability and the capabilities of non-invasive remote patient monitoring to reduce patient and provider contact during the COVID-19 crisis.
- In order to support overwhelmed physicians, CMS is now permitting physicians whose privileges will expire to continue practicing at a hospital, and allowed new physicians to begin working, prior to a full governing body review or approval. CMS has also waived paperwork requirements to allow physicians to utilize verbal orders and cut down the time spent processing written medical orders.
- To help ease the financial burdens created by the pandemic, CMS expanded its Advanced Payment Program to provide qualifying physicians an upfront payment of up to three months’ Medicare payments. While physicians will need to repay this advance, CMS extended their repayment window to give physicians 201 days from the date of payment.
- To address pharmacy shortages, the FDA is now allowing compounding pharmacies to make and sell drugs to hospitals when those drugs are not available through the traditional hospital supply chain. Additionally, the FDA is now allowing outsourcing facilities to sell drugs to hospitals.
- To help support patient care during a time of social distancing, CMS changed how they cover remote patient monitoring (RPM), making both changes to address needs during the pandemic and making permanent adjustments. CMS will now allow RPM to be utilized for new patients, as well as established patients and will only require consent annually for the duration of the pandemic. Going forward, CMS will allow RPM to be used for both acute care patients and patients with chronic conditions.
- On April 21st, HHS implemented enforcement discretion on its final interoperability rules. The regulations were put in place on March 9th to ensure that patients have access to their healthcare data during the COVID-19 crisis and to ensure that the data is protected and accurate.
- To support struggling rural facilities, CMS has waived federal minimum personnel qualifications for clinical nurse specialists, nurse practitioners and physician assistants, allowing them to work at rural hospitals as long as they meet state licensure requirements. Additionally, federal privacy regulations are now relaxed and payment policies are expanding to support the utilization of Telehealth services. Medicare Telehealth coverage now includes office visits utilizing Telehealth services and HHS is waiving Medicare’s cost-sharing requirements for COVID-19 treatment that is delivered via Telehealth.
- CMS now allows physicians and non-physician practitioners to utilize Telehealth services to provide care for patients located in long-term care facilities to help protect both the patients and providers and to adhere to social distancing guidelines.
Reinstating Regulations
While these changes have demonstrated a unified effort to support patients, providers and healthcare industry personnel, for many executives, these measures have also created a number of questions. Some of the most pressing questions for healthcare leaders include:
Will all of the roll-backs be reversed?
This question will not have a clear answer for a long time to come. While some roll-backs are designed to support specific areas of healthcare during this challenging time, other changes to regulations will have long-term impacts. There is reason to believe that measures taken to support the expansion of Telehealth, AI and RPM initiatives will continue to advance as the industry moves forward.
Who will be impacted by the change in regulations?
Each day on the front lines, the roll-backs are having an impact at all levels. Patients, providers, executives and payers are finding new ways to work together and are exploring new care innovations. Once the COVID-19 crisis is contained and the country begins to re-open, there will be opportunities to provide input at the local, state and national levels that will help guide how the roll-backs and the reinstatement of regulations impact the industry.
What date will the roll-backs expire?
At this time, CMS and other regulatory bodies are not offering specific timelines or plans, but rather allowing themselves to remain flexible in this unchartered territory. CMS in particular has stated that it will continue to monitor and review the impact of the pandemic on clinicians, facilities, programs and providers, and will update regulations and guidance as needed.
Preparing a Post-Pandemic Plan
Hospital leadership will have a great deal to contend with in managing new regulations, new IT possibilities and new care practices, as well as opportunities to innovate clinically, financially and operationally. It is becoming clear that a “new normal” will emerge in the post-COVID-19 era; however, it is still unclear what exactly that new normal will look like. Many executives predict that the more costly functions and processes in the healthcare ecosystem will be replaced on a permanent basis by more personal attention and more pre-emptive care, such as remote patient monitoring and digital therapies.
Additionally, many executives believe the push for change within the system will come from patients and their adjusted vision of what care delivery should look like after COVID-19.
The evolution of healthcare and its regulatory environment after the COVID-19 crisis is contained will have ramifications that extend outside the industry as well. With a greater focus on digital adoption and potentially more flexible regulations that support the use of new technologies, nontraditional healthcare players will have the opportunity to build new, creative partnerships within the healthcare industry to support innovation and improvements.
