The COVID-19 pandemic has changed the face of the health care industry on multiple fronts. These range from the multiple blanket 1135 temporary waivers issued by CMS that control how care for federal program beneficiaries could be delivered and by whom, the changing modalities for surveys by regulatory and accreditation agencies, to the relaxation of Stark and Anti-Referral Kickback limitations on physicians. Some of these changes have already been adopted permanently because of the clear benefits to both patients and providers while others will likely expire after the PHE ends. The health care landscape is now vastly different from anything we could have envisioned a year ago. And a year from now, how will these changes be reflected in our work and industry on a more permanent basis?
In recent years, telehealth services had been a small but growing element of healthcare in the US. After the PHE was declared, telehealth services became a critical lifeline for many Americans isolated by COVID-19. Before the PHE, only 15,000 fee-for-service beneficiaries each week received a Medicare telemedicine service. Since the beginning of the pandemic under its 1135 waivers, CMS has added 144 telehealth services such as emergency department visits and inpatient and nursing facility visits that are now covered by Medicare through the end of the PHE. From March through October, 2020, data show that over 24.5 million out of 63 million Medicare beneficiaries received some telemedicine service.
On December 1, 2020, CMS release notice the 2021 Medicare Physician Fee Schedule final rule (PFS) which included changes to the Medicare telehealth payment policy as well as other pandemic-driven changes that will remain in place after the PHE ends.
The final rule has direct impact on Medicare telehealth services in rural areas, allowing rural beneficiaries who are in a medical facility to continue to have continued access to telehealth services on a permanent basis. This rule also extends coverage for certain other services through the end of the calendar year in which the (PHE) ends. However, CMS does not have the statutory authority to pay for telehealth services outside of rural areas after the PHE ends. For the full range of telehealth services currently available to all Medicare beneficiaries during the PHE to be made permanent, congressional action is required.
Other changes enacted by CMS in the 2021 PFS final rule are equally significant. CMS finalized an historic increase in payment rates for many outpatient in-person medical visits to address the increasing demand of increased Medicare enrollment and case complexity. These adjustments ensure CMS is appropriately recognizing types of care where clinicians need to spend more face-to-face time with patients. The PFS also makes permanent several changes related to care by non-physician practitioners, as discussed below in the next section.
Changes in Scope of Practice
After the 1135 waivers went into effect, ancillary provider associations advocated to make the temporary changes to the scopes of practice of their members permanent.
> The American Academy of Physicians Assistants (AAPA) sent a letter in August, 2020 to the CMS Administrator, requesting that these changes be permanent. One 1135 waiver had temporarily removed the requirement that hospitalized Medicare patients must be under the care of a physician, thereby allowing PAs to direct care. Citing the benefits to both patients and the US health care system by allowing PAs increased autonomy to direct care, the association’s letter made its case for the change: “The PA profession remains fully supportive of team-based care. However, care teams don’t always have to be led by physicians. The team should be designed around the patient’s care needs and best interest. Efficient care delivery occurs when PAs, physicians, and other healthcare professionals work together to provide quality care without burdensome or restrictive administrative and regulatory constraints.”
> In August, 2020 the American Association of Nurse Practitioners similarly advocated to prioritize access to care for all patients by enacting legislation that enables NPs to practice at the top of their education and clinical training. “Governors and state elected officials must support our ability to treat patients in more than 1 billion patient visits each year by immediately acting to enable NPs to practice to the top of their education and clinical training. The practice barriers of the past have no place in our current crisis — or in the future of health care” said AANP President Sophia L. Thomas.
Not surprisingly, the American Medical Association opposed these requests. More than 100 physician groups, led by the AMA, informed CMS that, while they supported temporary regulatory relaxations in response to COVID-19, they were strongly opposed to certain rules changes being made permanent. “We urge CMS to sunset the waivers involving scope of practice and licensure when the public health emergency concludes. To our dismay, it is our understanding that some organizations have already been advocating to make the temporary waivers permanent – permanently diminishing physician oversight and supervision of patient care.”
In the 2021 Provider Fee Schedule (PFS) referenced earlier, notwithstanding the noted AMA objections, CMS made permanent certain workforce flexibilities for nurse practitioners and physician assistants. This allows PAs and NPs to supervise performance of diagnostic tests within their scope of practice as they maintain required statutory relationships with supervising or collaborating physicians. New flexibilities were also accorded to physical, speech and occupational therapists.
Physician Practice Arrangements
While the AMA had concerns about making permanent the expanded autonomy of non-physician providers, it fully supported another temporary change that occurred due to the pandemic – the temporary waivers of sanctions under the federal physician self-referral law, commonly referred to as the “Stark Law”. Under these temporary waivers, health systems could offer free use of medical office space to physicians and deploy hospital staff to a physician’s office to assist with care, treatment and care coordination between the hospital and the physician practice. In addition, CMS waived the “fair market value” requirement thereby allowing a hospital to pay a physician either above or below fair market value for their professional services, as well as allowing physicians to pay below market value for rentals of space, equipment and purchases of items or services. These flexibilities were intended to address the sudden and significant changes in relationships between health care entities due to COVID-19 and are scheduled to expire at the conclusion of the PHE.
While CMS has not indicated that the temporary Stark Law waivers will be made permanent, CMS and the OIG recently finalized rules to modernize the Stark Law and modify the AKS. Due to the complexity of the current rules related to Stark and the AKS under the CMS waivers, the OIG recently restated its availability to address specific arrangements being considered by physicians or health systems. Also, CMS may add pandemic-era waivers to its value-based payment (VBP) models as a way to spur increased provider participation in Medicare, CMS Administrator Seema Verma said. “A lot of what we did during COVID could potentially be moved to the value-based care models and provide more flexibility to providers,” Verma said
Changes in Survey Practices
Another consequence of COVID-19 has been the adoption of virtual survey and oversight modalities by state survey agencies and accreditation organizations. Soon after the declaration of the pandemic, CMS suspended all routine survey activities allowing facilities and practitioners to instead focus on the increased volume and complexity of COVID-19 cases. Survey activities to investigate allegations of serious patient safety and quality of care related to COVID-19 care continued but from a safe distance through virtual reviews where possible.
CMS guidance issued in mid-August did not seem supportive of virtual inspections when the agency announced that survey activities at nursing homes were being expanded to include on-site health/safety visits and state inspections where adequate survey staff and protective equipment were available. Whether the virtual inspection/survey process is permitted by CMS after the pandemic ends remains an open question.
HHS Renews Public Health Emergency
On Jan. 7, 2021 the U.S. Department of Health and Human Services (HHS) formally renewed the COVID-19 public health emergency declaration (PHE), effective Jan. 21, for an additional 90 days. This means that waivers and other regulatory actions associated with the PHE may also be extended.
As the COVID-19 pandemic continues to shape health care in 2021, the actions that may be taken at the state and federal levels to meet the challenges of COVID-19 continue to evolve. The flexibilities adopted in 2020 demonstrate the ability of our nation to adopt new modalities in unprecedented circumstances such as this pandemic. While we are clear that certain changes are here to stay, the full impact of the pandemic on our health care system remains unknown. However, it appears quite likely that the pandemic illuminated certain longstanding shortcomings which are now being addressed on a long-term basis due to the current pressures the healthcare industry is facing.