The Future of CMS 1135 Pandemic Waivers—Will They Survive COVID-19?
This Featured Article is contributed by AHLA's Regulation, Accreditation, and Payment Practice Group
- July 24, 2020
- Elizabeth Dahl Coleman , Mellette PC
- Peter Mellette , Mellette PC
When the service delivery and payment rules are relaxed, what long term changes are likely? In response to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) introduced several blanket waivers pursuant to its 1135 waiver authority.[1] These blanket waivers affect a broad swath of providers in different practice areas.[2] The particular waivers issued in response to COVID-19 modify certain requirements for the provision or payment of care in an attempt to allow providers dealing with pandemic conditions to focus on patient care.[3]
Many providers have recognized the ability to deliver the same or improved quality care with greater flexibility and may seek continuation of certain waivers indefinitely following the pandemic. While there are potential benefits to patients and providers by permanently waiving some requirements, loosening certain requirements could negatively impact the quality of patient care or lead to potential abuse. This article highlights certain waivers and their prospects for survival post-pandemic.
Expansion of Telehealth Services
Telehealth waivers are primary candidates to survive the pandemic.[4] Under pre-COVID-19 guidance, CMS covers telehealth services if the individual receiving the service lives in a rural area and receives the telehealth service at a designated clinic, hospital, or other medical facility.[5] Recipients require an audio and visual connection to providers to ensure the services are rendered in “real time.”[6] There are also limitations on what types of providers can render services using telehealth, as well as limitations on the types of services that can be delivered via telemedicine.[7] CMS has traditionally viewed telehealth as a less appropriate way to treat patients compared to in-person services. CMS and state Medicaid programs have primarily restricted the use of telehealth to patients in remote, rural areas with more limited access to physical sites.
However, in recognition of the need to keep potentially infected individuals at home to contain the spread of COVID-19, CMS issued guidance waiving certain eligibility requirements for the provision of telehealth.[8] Providers may now temporarily bill for services rendered to patients regardless of their home location pursuant to these waivers.[9] CMS further expanded the waivers in April to allow rehab providers to offer telehealth services.[10] Patients may remain in their homes or in a health care facility and receive telehealth services, and either audio or video functions are acceptable for telehealth visits.[11] For example, patients in skilled nursing facilities who typically require in-person provider visits may now receive telehealth visits if appropriate.[12] Initial and follow up home health agency assessments of prospective patients also are temporarily allowed.[13] By waiving the more restrictive requirements, providers have been able to continue reaching patients and providing necessary services during the pandemic, without risking the transmission of the virus and preserving precious personal protective equipment (PPE) needed for direct patient contact.
CMS’ increased flexibility in the use of telehealth services allows patients to receive timely, efficacious care. By experimenting during the pandemic, providers have found that virtual care is possible and often works just as well as in-person care. CMS has recognized the phenomenal increase in use of telehealth.[14] Nearly 48% of physicians are now treating patients through telehealth, and a survey found that 59% of patients are more likely to use telehealth now than they were prior to the pandemic.[15] Telehealth has proven appropriate for preventative, routine, and maintenance care, and allows patients who might be anxious about risking infection from inpatient care to access continued care for chronic issues, mental issues, or new health concerns. The provision of remote care decreases risk to providers and other patients of the spread of disease, and this will continue to be true long after the current pandemic recedes.
The telehealth waiver still requires providers to determine that using telehealth is medically appropriate for a patient, and there are certainly instances where physical, in-person examinations will remain necessary. Ultimately, the ease and timely access to services offered through telehealth might even persuade individuals who are typically less likely to seek out care to prioritize their health needs. When certain treatments, such as for chronic conditions, require multiple follow-ups and appointments, the ability to access that service through a computer or phone rather than traveling to a provider location on a frequent basis might be beneficial to patients with limited time or ability to keep such appointments.
Yet drawbacks remain to widespread telehealth implementation. The provider and patient both require reliable access to a secure communication system. Both parties need to be capable of using the modality, and the technical training could be time intensive and potentially challenging to grasp for providers and patients alike. Telehealth continues to raise potential limitations in the efficacy of treatment or gaps in care. Practitioners who can read physical cues in face-to-face visits that are essential to adequately diagnosing and treating a patient might be limited in their ability to do so over a remote connection. In addition, a patient’s ability to reach a broader network of providers might encourage provider shopping, resulting in potential disruptions in continuity of care and effective treatment.
While telehealth has been used effectively on a large scale, concerns surrounding privacy and appropriate safeguarding of patient records and treatment remain. With recent technology concerns,[16] providers will need to continue to establish secure and safe connections and modalities to render services via telehealth.
Adjusting payment schedules and avoiding fraudulent uses of telehealth services are additional considerations. Under the current waivers, providers can bill for telehealth services as if they were performed in person. Any continuation of these measures will likely require cost savings adjustments and recognition that the provision of telehealth services might be less costly than an in-person visit. The use of telehealth also may allow providers to effect schemes to order unnecessary treatments or medical supplies for patients without sufficient oversight that would not occur in an in-patient setting.[17]
CMS’ continuation of pandemic telehealth provisions indefinitely will require assurances that telehealth services are secure enough and can provide the same type and quality of comprehensive care to patients. Providers will likely need protocols for determining when a service is efficiently rendered through telehealth, and CMS will need audit pathways to prevent fraudulent use of telehealth services. CMS will also need to examine the potential for different reimbursement strategies in recognition of the potential cost savings afforded through telemedicine. A newly introduced congressional bill would mandate the Department of Health and Human Services undertake a study on the use of telehealth during the pandemic, including the number of telehealth visits, types of services provided, and the facilities that offered these services.[18] The results of such study may be useful in determining the extent to which telehealth services may be covered under future CMS guidelines.
Requirement of a Three-Day Hospital Stay for Skilled Nursing Facility Coverage
Among the many CMS blanket waivers issued in response to the pandemic are those related to the provision of skilled nursing services following a hospital stay. CMS has long required that a patient have a medically necessary three-day consecutive prior hospitalization prior to being admitted to a skilled nursing facility (SNF) to be eligible for coverage.[19] The patient must be admitted for SNF care within 30 days of a hospital stay.[20]
CMS is currently waiving the three-day requirement, and patients may be eligible for coverage regardless of a prior hospital stay.[21] This waiver is intended to eliminate barriers to treatment or coverage. Medicare beneficiaries often fail to have their SNF stay covered due to hospitalization trends resulting in shorter inpatient stays and longer overnight observations in outpatient status.[22] Continuation of this waiver could improve patient care and reduce cost sharing for beneficiaries who do not meet this requirement and would otherwise need to cover their own necessary stay in an SNF for extended care.
Of course, a qualifying three-day stay ensures Medicare payment is reserved for those who truly need continued medical treatment after a hospital stay.[23] Without this prerequisite, Medicare may pay for stays that are unnecessary or where other care, such as home care, could be more appropriate. CMS’ predominant concern with continuing the waiver is the likely increase in claims and a corresponding increase in Medicare costs from more eligible SNF stays.
Hospitals’ Ability to Provide SNF Care
CMS has also allowed previously ineligible hospitals to now offer long term care swing beds for COVID-19 and other patients who meet SNF care criteria. Prior to the issuance of this waiver, hospitals were only able to offer swing beds in the facility if they met certain requirements, including being in a “rural” area and having less than 100 beds.[24] Thus, patients who needed additional care but not acute care would have to be transferred out of the hospital, to facilities such as SNFs. However, SNFs are not obligated to accept patients with COVID-19. In the interest of addressing potential refusals and reducing facility transfers of patients to minimize viral spread, CMS has waived bed size and location eligibility requirements, letting hospitals establish SNF swing beds and receive payment under the SNF Prospective Payment System.[25]
Hospitals using this waiver must comply with all conditions of participation and the SNF provisions at 42 C.F.R. § 482.58(b).[26] The hospital must also attest that it made a good faith effort to exhaust all other options, there are no SNFs within the hospital’s catchment area that are able or willing to accept patients, and the hospital has a plan to discharge patients as soon as a SNF bed becomes available.[27]
A continued waiver of these eligibility requirements and the ability for more hospitals to establish swing beds within the hospital facility would allow patients to receive care in one setting without being discharged and transferred elsewhere. Some patients who do not need acute care might still need some level of base care to build up independence before going home, such as through limited wound care or occupational therapy. As the swing beds approved under this waiver do not have to be in a specific area of the hospital or a certain type of bed, the hospital can designate the bed that a patient is already in as a swing bed once the patient no longer needs acute care. Patients would potentially receive better outcomes by remaining in one place for the duration of their care rather than going through the process of transferring to a new SNF.
Continuation of the swing bed waiver post-pandemic would concern long term care providers. A hospital’s certification that no SNF option be available is difficult to audit and enforce, as the availability of SNF beds elsewhere could change day-to-day. Without a way to accurately monitor the availability of dedicated SNF beds, hospitals might be unnecessarily keeping patients in swing beds where a transfer could be less costly and more appropriate for their care.
Hospitals’ Ability to Provide Care at Different Locations
CMS also waived the requirements under the provider conditions of participation at 42 C.F.R. §§ 482.41 and 485.623. The waiver of these provisions allows hospitals to establish and operate as part of the hospital any location meeting the conditions of participation for hospitals.[28] By continuing this waiver, hospitals would have the autonomy to identify the need for overflow or surge capacity and the flexibility to temporarily develop those care sites.
However, CMS does not necessarily have the capability to determine the appropriateness of establishing temporary alternate care sites. In some states, appropriateness for approval of a new site is tied directly to state plans that establish guidelines.[29] Allowing hospitals to establish permanent authorized sites at will under these waivers is likely to increase costs, fuel unnecessary competition, and lead to potential waste of resources. Establishment of alternate care sites could also give providers a path to higher reimbursement rates, despite no actual need for surge capacity or for alternate care sites. As a result, CMS is unlikely to extend such waivers beyond the pandemic.
Waivers to Certain Supervision Requirements
Certain CMS provisions require that practitioners, like nurse practitioners and physician assistants, be supervised by a physician and limit the types of actions or care that can be provided by practitioners other than a physician. The recent CMS blanket waivers remove these requirements and allow practitioners to practice and provide care to the full extent of their licensure, consistent with state law.[30]
CMS has temporarily waived the requirement that all Medicare patients must be under the care of a physician[31] and that a certified registered nurse anesthetist be under the supervision of a physician.[32] In addition, CMS has waived the requirements that critical access hospitals must have a Doctor of Medicine or Osteopathy physically present to provide medical direction, consultation, and supervision for services provided,[33] and modified the requirement that a physician must provide medical direction for a rural health clinic and federally qualified health center health care activities and supervise the facility’s nurse practitioners.[34] CMS also has waived the requirement that hospitals designate in writing personnel that are qualified to perform specific respiratory care procedures and the supervision required for personnel to carry out specific procedures.[35]
These waivers essentially increase the number of available providers who can safely render care to patients, to the extent possible and in accordance with state law. The waivers allow licensed providers to operate to the fullest extent of their licensure, especially in states where nurse practitioners are given the opportunity for autonomous practice. Some of the waivers still require limited supervision or the ability to contact a supervising physician. A positive aspect of these waivers is that they allow hospitals and other providers to use their practitioners more effectively and ensure the availability of individuals to care for patients.
However, continuation of these waivers raises concerns about patient care and CMS’ ability to assure quality controls across all enrolled providers. The requirements for physician oversight provide additional assurance that hospitals and providers are offering a certain standard of care. These requirements ensure oversight by someone with extensive, general training who can direct and coordinate patient care. Without supervision, some providers might perform tasks outside the scope of their training or fail to follow the protocols that are typically overseen and monitored by a supervising physician. In addition, there are different licensure requirements across states, which might result in some providers that are able to practice under this waiver having less experience than required by another state.
By ensuring physician supervision, CMS can establish a basic level of care that is consistently offered across all enrolled providers. However, given the states’ historic role in licensing, CMS may well rely on states to continue care supervision by continuing the waiver after the pandemic.
Delegation of Duties in Long Term Care Facilities
Under pre-pandemic rules, a physician following a SNF resident may not delegate a task if the regulations specify that the physician must perform it personally.[36] CMS typically requires certain physician visits to be made by the attending physician.[37] During the pandemic, CMS has waived these requirements.[38]
To the extent allowed by state law, nurse practitioners, physician assistants, or clinical nurse specialists may now perform delegated duties as determined to be appropriate by the physician.[39] Physicians also may delegate visits as appropriate to a nurse practitioner, physician assistant, or clinical nurse specialist working with the physician.[40] The waivers still require supervision by the physician and do not allow the delegation of duties where specifically prohibited. Arguably, these waivers allow for more efficient use of staff and provision of care to patients. Long term care facilities are typically more reliant on nursing staff and may encounter staffing shortages that can impact the timely provision of care. The waiver of requirements resulting in the physicians’ ability to more efficiently delegate tasks to individuals who are also able to perform these duties frees up physician time and takes the strain of reporting back to the physician off certain practitioners.
Yet, these CMS provisions were likely put in place to ensure that a physician could oversee the care of a patient and ensure continuity of the care plan. By delegating duties and patient checks to less trained providers, an aspect of the patient’s care might be overlooked and potentially result in patient harm. Given the number of COVID-19 deaths in long term care facilities during the pandemic, CMS is unlikely to increase nursing facility flexibility by continuing the waivers.
Patient Access to Records in Long Term Care Facilities and Home Health Agencies
Patients and residents are entitled to access their care records in a reasonable time frame. While some states give providers a 30-day limit to produce records, CMS has required different time limits for producing records for patients in long term care and home health agencies as part of the residents’ rights.[41] CMS modified the requirement that long term care facilities provide a resident a copy of the patient records within two working days to allow up to ten working days for the facility to produce a copy of the records.[42] Home health agencies have had their time to produce records extended from four business days to ten business days.[43]
Providers likely find this extension beneficial and more reasonable, especially during this public health crisis, as they can prioritize care rather than rushing to collect and produce records within a short time period. However, resident-focused care should enable residents to participate in their own care by accessing their records, and providers increasingly using electronic health records should be able to turn over complete electronic records quickly. While post-pandemic changes to the deadlines are possible, continuation of this waiver is unlikely.
Use of Focus Surveys in Long Term Care
Another change that might impact long term care facilities moving forward is the updates to regular surveys of nursing facilities. CMS is currently prioritizing complaint or facility-reported incident surveys, targeted infection control surveys, and self-assessments.[44] Standard surveys and revisits are suspended for the time being to minimize facility resident, staff, and surveyor exposure and to focus surveys on infection control and abuse.[45]
The benefits of these waivers are that facilities can prioritize addressing the most serious incidents while continuing to focus on providing patient care. Making the surveys more focused on specific incidents also could allow facilities to better prepare for the survey. However, the concern with limited focus surveys is that it shifts the focus to emergent surveys, potentially putting routine practices that ensure facility compliance with CMS standards and industry protocols on the back burner. Traditional surveys may uncover situations that, upon discovery and correction, might avoid a future emergency.
While some long term changes and modifications to the survey process could be beneficial to facilities in terms of workload and ability to prioritize care, the need remains to ensure oversight of facilities and to identify and fix problems that might exist before they escalate to patient harm.
Other Blanket Waivers
There are other blanket waivers not discussed above that are of likely interest to health care attorneys and their clients; for example, the waivers applicable to the federal Anti-Kickback Statute and Stark Law.[46] The Department of Health and Human Services Office of Inspector General issued a policy statement confirming that it will exercise discretion in issuing sanctions pursuant to the Anti-Kickback Statute for certain services provided in response to COVID-19.[47] CMS also issued blanket waivers of certain requirements under the Stark Law.[48] These exceptions to enforcement do not necessarily affect state analogs and will not continue indefinitely; however, they will likely provide some fodder for future modifications of the Stark Law and Anti-Kickback Statute.
Conclusion
The need for 1135 waivers highlights the complexity of CMS certification and payment requirements. The pandemic caused CMS to rethink the purpose of certain regulatory requirements on a short-term basis and has created an experiment period where the requirements do not exist. Certain requirements may be permanently removed as a result. Waivers relating to telehealth and remote care are most likely to become standard practice, provided there is evidence of the efficacy of such telehealth services. Patients and providers alike have noticed the ease of relying on this technology to improve services and make treatment more accessible.
Relaxed supervision and delegation requirements also have shown how providers can more effectively utilize practitioners and ensure that patients are receiving timely, yet quality, care. However, given differing state licensure requirements across CMS enrolled-providers, continued physician supervision allows CMS to set standards of care and requirements for payment.
Many waivers will not continue indefinitely. CMS waivers extending necessary reporting requirements, waiving quality program requirements, and relaxing training and site-of-service delivery requirements will likely lapse. These quality protocols and reporting requirements are necessary for ensuring that patients are safe and properly cared for, as are the training requirements to ensure that providers are qualified to provide this care. Site-of-service expansions are not consistent with recent changes to provider-based payment rules.
CMS, and potentially lawmakers, will need to weigh the quality and efficiency benefits against risks in retaining any of these waivers and take into consideration how the waivers can improve the timely and effective provision of care to patients across the country while reducing patient and payer costs. In turn, providers who recognize significant waiver-related benefits in the provision of care will need to advocate for changes that they feel are necessary, while addressing the potential concerns.