How COVID Changed the Rules: Reappraising the Future of COVID-19 Waivers

• April 08, 2022

• Peter Mellette , Mellette PC
• Elizabeth Dahl Coleman , Mellette PC
• Shannon Porterfield , Wake Forest University School of Law

Update to The Future of CMS 1135 Pandemic Waivers—Will They Survive COVID-19?

In the frenzied early days of the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) introduced dozens of blanket waivers pursuant to Section 1135 of the Social Security Act. The pandemic has highlighted the benefits that many of these waivers have brought to patient care and health care access, resulting in much discussion as to whether these waivers will become permanent following the end of the declared Public Health Emergency (PHE). Two years after the initial declaration of the PHE, what can providers expect? This Briefing contemplates waivers that will likely survive post-pandemic and waivers providers should expect to unravel at the end of the PHE.[1]

Telehealth Is Here to Stay

With the declared PHE ostensibly ending soon, many providers are hopeful that action will be taken to make CMS waivers issued during the pandemic permanent. It is not hard to see why: hospitals and providers have been able to focus on patient care, take greater advantage of technology and its use in providing care, and reduce the burden on patients and staff. Out of the numerous waivers issued during the PHE, telehealth expansion has arguably been the most beneficial to patients and providers alike.

Both patients and providers have found that telehealth is an extremely convenient option for delivering care. Over 28 million Medicare beneficiaries used a telehealth service during the first year of the pandemic. This number represents 43% of the 66 million beneficiaries enrolled in Medicare, or two in five Medicare beneficiaries.[2] Within the first year of the pandemic, Medicare beneficiaries used 88 times more telehealth services than in the preceding year.[3] Since its increased usage during the pandemic, 73% of the population plans to continue utilizing telehealth post-pandemic, up from 58% in 2020.[4]

The telehealth waivers have made it easier for patients to access a wider variety of services from more convenient locations. Prior to the waivers, patients were required to go to a health care facility to initiate a telehealth visit. Now, the majority of telehealth visits occur in patients’ homes.[5]

The waivers have also expanded the types of services covered, enabling access to services that patients might have been reluctant or unable to access before. The waivers especially aided individuals seeking mental health treatment and substance abuse treatment, both areas that have experienced increased use due to pandemic stressors. Behavioral health specialists reported the largest increase in use of telehealth during the pandemic.[6] An 1135 waiver also covers services offered by speech language pathologists, physical therapists, and occupational therapists via telehealth. Recent legislation has eliminated the geography and facility restrictions for behavioral health services and permanently continued coverage of telehealth services from speech language pathologists, physical therapists, and occupational therapists, further suggesting that telehealth will continue to be available for a larger variety of services and without limitation on where the service occurs.[7]

Various health organizations have put pressure on lawmakers to pass legislation that would expand telehealth capabilities permanently. On March 17, 2022, Congress enacted the Consolidated Appropriations Act (CAA), which includes provisions to extend the telehealth waivers for 151 days (approximately five months) following the end of the PHE.[8] During this period, Medicare will continue to cover an array of telehealth services.[9] The CAA also delays the requirement that patients receiving mental health services be examined in person by the provider within six months of starting treatment.[10] While this requirement has been delayed, it appears likely that future legislation will include this requirement as an oversight to telehealth services.

The CAA directs various groups to undertake studies that will provide guidance on utilizing telehealth moving forward. The CAA directs the Medicare Payment Advisory Commission (MedPAC) to conduct a study on the expansion of telehealth services under Medicare as a result of the PHE.[11] MedPAC’s study is expected to analyze: the utilization of telehealth services under the Medicare program; Medicare program expenditures on telehealth services; Medicare payment policy for telehealth services and alternative approaches to this payment policy; and the implications of expanded Medicare coverage of telehealth services on beneficiary access to care and quality of care.[12] The CAA also directs the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to issue a report by June 2023 regarding the program integrity risks associated with Medicare telehealth services.[13] OIG’s report should include recommendations to prevent waste, fraud, and abuse under the Medicare program.[14] The CAA also directs CMS to begin publishing data to its website beginning July 1, 2022 on a quarterly basis regarding the Medicare claims for telemedicine services, including data on utilization and beneficiary characteristics.[15]

Senator Cortez Masto introduced the Telehealth Extension and Evaluation Act on February 7, 2022 in recognition of the benefits and increased usage of telehealth services.[16] This legislation as drafted would extend Medicare reimbursement for telehealth services for two years after the PHE ends in order to allow Congress to establish a study on the efficacy of telehealth and whether broader access should be permanent.[17] The Act would extend geographic and site restrictions to allow beneficiaries to continue to access telehealth at home;[18] expand covered telehealth providers and allow for audio-only telehealth services;[19] create an exception that would allow Drug Enforcement Administration-registered practitioners to prescribe controlled substances without a prior in-person medical evaluation of the patient as long as real time, interactive audio-visual communications are used;[20] extend Coronavirus Aid, Relief, and Economic Security Act flexibilities that allow federally qualified health centers and rural health clinics to serve as distant sites;[21] and require ordering clinicians to conduct in-person exams within 12 months of ordering high-cost lab tests and durable medical equipment products via telehealth.[22]

The Telehealth Extension and Evaluation Act would also commission a study on the impact of extending these flexibilities past the PHE and provide guidance as to which telehealth flexibilities should be made permanent.[23] The study would culminate in a report that includes a summary of the utilization of all Medicare services furnished during the PHE, a comparison in utilization of telehealth services before and during the PHE, a breakdown of telehealth utilization by beneficiaries’ demographics, and a description of costs and savings, instances of fraud, privacy concerns, and recommendations.[24]

Any future legislation making these telehealth flexibilities permanent will likely include significant guardrails to ensure that providers do not abuse telehealth flexibilities and that patients continue to receive appropriate care. For example, providers will likely have to see behavioral health patients in person on a six month or annual basis to ensure there is necessary oversight and patient interaction. Program integrity and cost will also be key considerations. CMS will likely require providers to keep precise documentation supporting the use of telehealth and the care given to patients to ensure reimbursement. In addition, health care providers may need to meet additional privacy protections, including Health Insurance Portability and Accountability Act-compliant vendors for video communication products.[25]

Potential Extension of Other Waivers

The future of other waivers is less certain. Health associations have advocated for permanent waivers of “hospital-at-home” programs. These programs allow for approved providers to offer hospital-level care to eligible patients in their homes. According to the American Hospital Association, these programs improve patient safety, increase access to care, result in high patient satisfaction, and alleviate capacity at hospitals while addressing staffing issues.[26] Advocates for permanent waivers suggest that such programs lead to reduced lengths of stay for patients; however, data on the clinical benefits are not concrete. Allowing hospital-level care to be provided in patients’ homes can result in more risk to patients, less oversight, and an inability to ensure quality of care. There is also less immediate access to physicians in the event of an emergency, as the patient is not in the hospital setting.

Another waiver that may potentially result in permanent changes to Medicare payment limits relates to current limitations on provider discharge of hospital patients to skilled nursing facilities (SNFs). The PHE waiver of the three-day hospitalization requirement for Medicare SNF care and other Medicare skilled care access rules was intended to respond to hospital overcrowding and allow appropriate patients to receive subacute care in another location, freeing up hospital beds for more acute and infectious patients. Many commentators have noted the usefulness of loosening these requirements. However, others have cited the strain on Medicare funds resulting from the waiver and warn that continuation of coverage for nonqualifying patients could deplete necessary funds.[27]

Yet, it appears that most agree that the waiver of the “three-day rule” should be made permanent.[28] Prior to the CMS waivers, a patient must have a qualifying three-day hospital stay before they would receive coverage of a stay at a skilled nursing facility. A recently introduced bill, the Improving Access to Medicare Coverage Act,[29] would permanently waive the three-day inpatient hospital stay requirement for Medicare coverage of a skilled nursing stay.[30] The proposed legislation would count the time that Medicare beneficiaries spend in the hospital under “observation status” towards the three-day stay requirement. The bill aims to allow hospitals to reserve beds for severely ill patients by allowing those that could recover at a SNF to be discharged sooner.[31] Patients often are surprised to learn that their skilled nursing stay is not covered because they did not meet the three-day stay requirement, particularly when observation days do not count toward the requirement. This legislation would be consistent with recent efforts to ensure that patients are not subject to surprise billing and receive coverage for necessary care. Making this waiver permanent could lead to improvements in patient care and help reduce cost-sharing for beneficiaries.

Expect to Say Goodbye to These Waivers

During the PHE, CMS temporarily waived licensing requirements to increase the number of providers that could treat patients and to prevent overcrowding of hospitals. As the end of the PHE looms, it is likely that these waivers will expire and will not be made permanent.

For example, licensed practitioners were temporarily able to bill Medicare and Medicaid for patient care in another state without being licensed in that state if the service was being provided pursuant to the PHE.[32] While this was useful to increase the number of available providers during the PHE, it is likely unnecessary when the PHE is over. States are allowed to have varying licensure requirements and ensure that providers practicing in the state meet particular requirements. Licensing requirements will likely resume to guarantee providers maintain a certain level of quality across the board and ensure that there is no unfair competition between local practitioners and out-of-state providers.

Similarly, the medical staff membership waivers that allowed Medicare payment for physicians with expiring privileges to continue practicing or for new physicians to practice before full medical staff review will likely unravel at the end of the PHE. Again, the purpose of these waivers was to increase the number of providers available to treat patients during the pandemic. With the expiration of the PHE, there is less need to bring practitioners on without the full review that allows hospitals to maintain the quality standards of their providers.

Many waivers related to temporary relaxation of required policies and procedures during the PHE, including utilization review and quality assessment and performance improvement programs, are expected to end. These CMS flexibilities allowed hospitals to focus on providing necessary care during the PHE rather than focusing on quality assurance programs. However, at the end of the PHE, CMS likely believes that hospitals should be able to devote necessary time to running these programs and reviews and ensuring that the hospital and its staff are meeting quality standards.

The waivers allowing for temporary expansion of locations and bed/service size will also likely end. These waivers allowed flexibility for existing providers to expand their service locations to meet Medicare beneficiaries’ needs in recognition of the large numbers of patients who required care. With the end of the PHE and patient numbers stabilizing, providers will be expected to serve patients in their approved locations and seek necessary CMS and state authorizations for expansions, including any other distinct locations.

Other waivers of note include flexibilities in the use and authentication of verbal orders by waiving requirements related to the frequency of verbal orders for the use of drugs and biologicals; the prompt dating, timing, and authentication of verbal orders; limits on hospital use of standing orders; and signed written order requirements for medication administration.[33] With the end of the PHE, circumstances that keep physicians from having quick physical access to patients’ medical records should cease, likely eliminating the need to continue these waivers.

Many waivers related to long term care and home health will also likely end.[34] For example, the extended deadlines by which facilities had to produce medical records to residents[35] will likely be lifted, as patients should be afforded quick access to their medical records and facilities should have the resources and time to ensure that quick access. Requirements that limited the delegation of tasks by a physician[36] were also waived during the PHE, allowing nurse practitioners, physician assistants, and clinical nurse specialists to perform delegated duties as deemed appropriate by a resident’s physician.[37] While the waivers did not suspend supervision requirements, it is unlikely that CMS will permit increased delegation of duties to continue absent more study. Physicians are uniquely situated to care for residents, and ad hoc delegation of tasks could result in resident harm. Finally, there will be a return of standard onsite annual surveys and revisits that were paused during the pandemic in efforts to minimize exposure to residents, staff, and surveyors and to focus surveys on infection control and abuse.[38] With the end of the PHE, the focus on emergent surveys will end as well, and routine oversight practices, including surveys, will resume.

During the PHE, CMS temporarily waived the requirement that all Medicare patients be under the care of a physician.[39] These waivers essentially increased the number of providers who could render care to patients under state law; however, now that the PHE is likely ending, physicians are ready for these waivers to cease.[40] Physicians point to their increased education and clinical experience as to why physicians are uniquely qualified to lead health care teams and care for their patients, in addition to claiming that these waivers undermine the physician-patient relationship.[41] While the waivers allowed nurse practitioners and physician assistants the expanded ability to practice,[42] CMS will likely leave it to individual states to determine whether such expanded scope of practice is appropriate under state licensing laws. This waiver was enacted to respond to an overworked health system by employing an “all hands on deck” approach that is less necessary following the end of the PHE.

Finally, CMS issued blanket waivers to requirements of the Physician Self-Referral Law (Stark Law), providing protection from the Stark Law for financial relationships that pertained to a COVID-19 purpose.[43] These waivers allow for certain arrangements for remuneration and referrals that would typically violate the Stark Law, including allowing entities to pay physicians for services above or below fair market value (FMV), permitting entities to offer benefits or gifts that exceed the monetary limits under the Stark Law, allowing loans between physicians and health care entities with an interest rate below FMV, and allowing physicians to refer beneficiaries to a home health agency that does not qualify as a rural provider and in which the physician has an ownership or investment interest.[44] In recognition of the fact that many arrangements allowed under the CMS blanket waivers could also violate the federal Anti-Kickback Statute, OIG issued a policy statement during the PHE that it would exercise its enforcement discretion to not impose administrative sanctions under the federal Anti-Kickback Statute for remuneration related to the PHE.[45] Pursuant to this policy, certain arrangements that satisfy the permissible forms of remuneration under the CMS waivers to the Stark Law are exempt from the Anti-Kickback Statute. These waivers are primarily intended to assist providers in working together to meet the needs of patients during the pandemic, but importantly do not offer exemptions to relationships that create fraud and abuse concerns. Following the pandemic, renewed enforcement of violations of the Stark Law and Anti-Kickback Statute is anticipated.

CMS intended the majority of waivers granted during the PHE to be time-limited and to allow providers to pivot their focus to providing necessary care, through bringing on more staff and expanding their facilities to accommodate the increased patient loads. While some of the waivers highlighted more efficient ways for moving forward, many of the waivers temporarily suspended quality checks and balances that were never intended to be permanently waived. With the end of the PHE comes the expectation that hospitals and other covered providers will have the time and resources to again follow these conditions for participation related to quality assurance and reporting requirements.

Conclusion

It has been over two years since the PHE began, straining the capacity of the health care system to meet care needs. Challenges in treating unusual numbers of infectious patients required quick thinking and new approaches to effectively provide care. In response, CMS issued numerous blanket waivers so providers could focus on providing care, whether by loosening licensing requirements or allowing care to be provided through new channels and in new locations. While some waivers proved that there were more efficient and convenient ways to serve Medicare beneficiaries, other waivers were only intended to temporarily relieve some of the administrative burdens on providers during the PHE. With an expected declaration ending the PHE to come, providers should refamiliarize themselves with CMS requirements of participation and billing, some of which CMS and its contractors have waived over the past two years. HHS has indicated that it will provide 60 days’ notice of the end of the PHE, but providers should begin taking steps now to comply with CMS’ requirements of participation to ensure no disruption in delivery and payment of services when the PHE ends.

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