On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B [CMS-1784-P] Proposed Rule, which includes proposals related to Medicare physician payment and the Quality Payment Program (QPP). Physicians and other clinicians are once again facing large, proposed cuts of more than 3.36% for CY 2024. While Congress has provided temporary partial fixes to physician payment in the last several years, its latest fix in the Consolidated Appropriations Act, 2023 (CAA, 2023), enacted at the end of 2022, does not offset all the proposed cuts in this rule. In all, the budget neutrality constraints of the fee schedule continue to result in a negative proposed conversion factor (CF) update. Beyond the cut to the CF, CMS proposes significant policies related to telehealth services, updates to the Medicare Shared Savings Program (MSSP), initiatives promoting health equity and other changes to further develop physician quality initiatives.

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KEY TAKEAWAYS FROM THE CY 2024 PFS PROPOSED RULE:

• CF Reduction: Proposes a 2024 CF of $32.7476, representing a 3.36% reduction from the 2023 physician CF of $33.8872, and a 2024 anesthesia CF of $20.4370, representing a 3.26% reduction from the 2023 anesthesia CF of $21.1249
• Add-on Code for Complexity: Would implement a new add-on code for complexity, G2211, that was previously finalized but delayed by Congress until 2024
• Behavioral and Social Needs: Outlines policies to promote behavioral healthcare and services addressing health-related social needs
• Telehealth: Proposes a new process for adding, removing or otherwise changing codes on the Medicare Telehealth Service list, and would create differential payment based on the place of service
• Merit-Based Incentive Payment System (MIPS): Would raise the MIPS performance threshold to 82 points in 2024, from 75 points in both 2022 and 2023
• Appropriate Use Criteria (AUC) Program: Would permanently sunset the AUC program
• MSSP: Proposes changes to the MSSP, including to the financial benchmarking methodology, assignment methodology and more.

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As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access the healthcare services they need in as safe a manner as possible. In order to provide our clients with quick and actionable guidance on the evolving telehealth landscape, Manatt Health has developed a federal and comprehensive 50-state tracker for policy, regulatory and legal changes related to telehealth during the COVID-19 pandemic. Below is the executive summary, which outlines federal developments from the past two weeks, new state-level developments, and older federal developments. The full tracker with details for each state is available through Manatt on Health, Manatt Health’s premium subscription service. 

New Federal Developments – No new federal developments over the last 2 weeks

New State-Level Developments

Note: As indicated in the table below, several states have recently taken action to update, continue, or renew their state of emergencies for COVID-19 in response to the rise of new cases linked with the Omicron variant. These updates are highlighted below because in many states, temporary telehealth flexibilities are tied to the status of state of emergency declarations.

Payment Parity Permanent State Laws and Statutes

Payment Parity requires that health care providers are reimbursed the same amount for telehealth visits as in-person visits. During the COVID-19 pandemic, many states implemented temporary payment parity through the end of the public health emergency. Now, many states are implementing payment parity on a permanent basis. As portrayed in Figure 1, as of April 2022, 21 states have implemented policies requiring payment parity, 5 states have payment parity in place with caveats, and 24 states have no payment parity.

_{Figure 1. Map of States With Laws Requiring Insurers to Implement Payment Parity (as of April 2022)}

Federal Developments More than Two Weeks Old

Executive Branch Activity

Legislative Activity

Relevant Telehealth Data and Reports

RAND Corporation released a report titled “Experiences of Health Centers in Implementing Telehealth Visits for Underserved Patients During the COVID-19 Pandemic”, which evaluated the progress of FQHCs that participated in the Connected Care Acceleration (CCA) initiative by investigating changes in telehealth utilization and health center staff experiences with implementation. The study found that although overall visit volumes remained about the same from the pre-pandemic to the pandemic study periods, the share of audio-only and video visits dramatically increased during the pandemic, and audio-only visits were the leading modality for primary and behavioral health. The study recommends continued study of telehealth trends, particularly regarding equitable access to telehealth.

In March 2022, the American Medical Association released their 2021 Telehealth Survey Report, which aimed to gather insights on the experiences of current and expected future use to inform ongoing telehealth research and advocacy, resource development, and continued support for physicians, practices, and health systems. Data was collected from individuals, state and specialty medical organizations, and members of the American Medical Association Telehealth Immersion Program. The survey indicated that 85% of physicians currently use telehealth, and over 80% of patients said that they receive better access to care since using telehealth. In addition, 54.2% of respondents indicated that telehealth has improved the satisfaction of their work, and 44% said that telehealth has lowered costs.

In March 2022, GAO published a report titled “CMS Should Assess Effect of Increased Telehealth Use on Beneficiaries’ Quality of Care”, which examined the use of telehealth among Medicaid beneficiaries before and during the COVID-19 pandemic across six select states: Arizona, California, Maine, Mississippi, Missouri, Tennessee. The report also explored the states’ experiences with telehealth during the pandemic, future plans for post-PHE telehealth coverage, and CMS’ oversight of quality of care for services delivered via telehealth. GAO found that five of the selected states delivered 32.5 million services via telehealth to approximately 4.9 million beneficiaries between March 2020 and February 2021, up from 2.1 million services delivered to about 455,000 beneficiaries during the same time period in the previous year. Notably, the report highlighted the need for improved data collection and analysis related to the quality of care delivered via telehealth. Based on the results of the study, GAO issued two recommendations to CMS: (1) collect and analyze information about the effect delivering services via telehealth has on the quality of care Medicaid beneficiaries receive, and (2) determine any next steps based on the results of the analysis.

In March 2022, the HHS-OIG released a data brief titled “Telehealth Was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic,” which examined trends in telehealth utilization among Medicare fee-for-service and Medicare Advantage beneficiaries from March 2020 to February 2021.  The data brief indicated that more than 40% of Medicare beneficiaries utilized telehealth during the first year of the pandemic, with use remaining high through early 2021. Beneficiaries used 88 times more telehealth services during the first year of the pandemic as compared to the prior year.

In March 2022, the American Medical Association (AMA) released a physician survey examining experiences with and perceptions of telehealth. Of the 2,232 provider respondents, nearly 85% indicated they currently use telehealth to deliver care to patients, while 70% indicated they plan to continue offering telehealth services. Moreover, 60% of providers surveyed felt telehealth enabled them to provide high quality care, while 80% of respondents indicated patients received better access to care since using telehealth.

In February 2022, the American Medical Association (AMA), in collaboration with Manatt Health, published a report titled “Accelerating and Enhancing Behavioral Health Integration Through Digitally Enabled Care,” which used findings from a diverse working group to highlight solutions that industry stakeholders can apply to address gaps hindering the equitable and sustainable adoption of digitally-enabled behavioral health integration (BHI). Solutions included: increasing BHI training for primary care and behavioral health providers through the incorporation of digitally enabled BHI into standard curricula, encouraging the incorporation of telehealth into BHI by implementing payment parity for behavioral health services delivered via video or audio-only modalities, and passing legislation to remove originating site and geographic restrictions for all telehealth services in Medicare that limit access to care.

In February 2022, Doximity, a provider networking and digital health service, published the second edition of its “State of Telemedicine Report,” which highlighted findings in patient and provider perceptions of telehealth based on surveys conducted between January 2020 and June 2021. Patients overall showed growing trust in telehealth as a mechanism for high-quality care, with 55% reporting that they felt telemedicine provided equal or greater quality of care than in-person visits in 2021, compared to 40% in 2020. In addition, approximately two thirds of physicians indicated that using telemedicine allowed them to build or preserve trust with their patients.

In February 2022, The U.S. Government Accountability Office (GAO) released a report titled, “Defense Health Care: DOD Expanded Telehealth for Mental Health Care during the COVID-19 Pandemic,” which focused on telehealth use in the military. Among active duty servicemembers, pre-pandemic telehealth visits made up 15% of mental health care visits, compared to 33% in April 2021. Department of Defense (DOD) officials highlighted the value of telehealth and its ability to improve access and continuity of care. In addition, officials suggested that telehealth may reduce the stigma of seeking mental health treatment by allowing servicemembers to receive care more privately without the risk of being seen in military treatment facilities.

In February 2022, the HHS Office of the Assistant Secretary for Planning and Evaluation released an issue brief titled “National Survey Trends in Telehealth Use in 2021: Disparities in Utilization and Audio vs. Video Services,” which compared differences in telehealth access for audio-only and video visits between April and October 2021. While overall telehealth utilization was similar across demographic groups, except among the uninsured, there were significant differences in video telehealth use. Rates of video telehealth use were lowest among Latino, Asian and Black individuals, those without a high school degree and adults ages 65 and older.

In October 2021, the HHS-OIG released a data snapshot report titled “Most Medicare beneficiaries received telehealth services only from providers with whom they had an established relationship,” which evaluated the relationship between providers and Medicare patients utilizing telehealth between March and December 2020. Notably, the data snapshot found that 84% of Medicare beneficiaries received telehealth services only from providers with whom they had an established relationship.

In October 2021, JAMA published an study titled “Changes in Virtual and In-Person Health Care Utilization in a Large Health System During the COVID-19 Pandemic,” which sought to assess the association between the growth of virtual care and health care utilization in an integrated delivery network. The study found that while COVID-19 caused in-person visits to decline and virtual services to increase, there was no significant change in the overall volume of healthcare utilization, suggesting that virtual care was substitutive, rather than additive in the ambulatory care setting.

In September 2021, the HHS-OIG released two telehealth reports “States Reported Multiple Challenges With Using Telehealth To Provide Behavioral Health Services to Medicaid Enrollees” and “Opportunities Exist To Strengthen Evaluation and Oversight of Telehealth for Behavioral Health in Medicaid” based on surveys conducted in early 2020. The surveys focused around telemental health delivery though managed care organizations.

In July 2021, AAMC in in partnership with Manatt Health published “Sustaining Telehealth Success: Integration Imperatives and Best Practices for Advancing Telehealth in Academic Health Systems”, conducting extensive interviews with many leading telehealth AMCs across the country (Ochsner, VA, Kaiser, MUSC, UMMC, Intermountain, Jefferson, etc.) and synthesizing best practices through this report.

In July 2021, The National Association of Community Health Centers (NACHC) published “Telehealth During COVID-19 Ensured Patients Were Not Left Behind,” which explores how health centers have utilized telehealth and the implications for health center patients should the PHE flexibilities not be extended. 

In June 2021, the Lucile Packard foundation published “COVID-19 Policy Flexibilities Affecting
Children and Youth with Special Health Care Needs” to identify key flexibilities enacted during the PHE related to children and youth with special health care needs (CYSHCN) and summarize stakeholders’ perspectives about the impact of policy flexibilities on CYSHCN and their families and providers.

In June 2021, the Commonwealth Fund published “States’ Actions to Expand Telemedicine Access During COVID-19 and Future Policy Considerations,” which examined state actions to expand individual and group health insurance coverage of telemedicine between March 2020 and March 2021 in order to better understand the changing regulatory approach to telemedicine in response to COVID-19.. Notably, the report found that twenty-two states “changed laws or policies during the pandemic to require more robust insurance coverage of telemedicine.” Three policy flexibilities that states focused on included: requiring coverage of audio-only services; requiring payment parity between in-person and telemedicine services; and, waiving cost sharing for telemedicine or requiring cost sharing equal to in-person care.

In June 2021, the Substance Abuse and Mental Health and Services Administration (SAMHSA) released “Telehealth for the Treatment of Serious Mental Illness and Substance Use Disorders,” a guide supporting the implementation of telehealth across diverse mental health and substance use disorder treatment settings. The guide examines the current telehealth landscape and includes guidance and resources for evaluating and implementing best practices that will continue to assist treatment providers and organizations seeking to increase access to mental health services via telehealth.

In May 2021, the National Academy for State Health Policy (NASHP) released “States Expand Medicaid Reimbursement of School-Based Telehealth Services” exploring how states are increasing Medicaid coverage of school-based telehealth services during COVID-19, determining which services can effectively be delivered through telehealth, and supporting equitable access to telehealth services for students.

In May 2021, the Kaiser Family Foundation published “Medicare and Telehealth: Coverage and Use During the COVID-19 Pandemic and Options for the Future” analyzing Medicare beneficiaries’ utilization of telehealth using CMS survey data between summer and fall of 2020.

In May 2021, the American Medical Association in partnership with Manatt Health published “Return on Health: Moving Beyond Dollars and Cents in Realizing the Value of Virtual Care”  to articulate the value of digitally enabled care that accounts for ways in which a wide range of virtual care programs can increase the overall health and generate positive impact for patients, clinicians, payors and society.

In March 2021, the Journal of the American Medical Association (JAMA) published “In-Person and Telehealth Ambulatory Contacts and Costs in a Large US Insured Cohort Before and During the COVID-19 Pandemic,” highlighting existing disparities related to the digital divide.

FAIR Health publishes a Monthly Telehealth Regional Tracker to track how telehealth is evolving comparing telehealth: volume of claim lines, urban versus rural usage, the top five procedure codes, and the top five diagnoses.

In February 2021, the Commonwealth Fund published “The Impact of COVID-19 on Outpatient Visits in 2020: Visits Remained Stable, Despite a Late Surge in Cases” tracking trends in outpatient visit volume through the end of 2020 hoping to track what the clinical impacts of the pandemic are and how accessible has outpatient care been, if there are new policies encouraging greater use of telemedicine, and what has been the financial impact of the pandemic on health care providers.

In February 2021, the California Health Care Foundation in partnership with Manatt Health published “Technology Innovation in Medicaid:What to Expect in the Next Decade,” a survey of 200 health care thought leaders in order to learn where health technology in the safety net is expected to go over the next decade.

In February 2021, Health Affairs published “Variation In Telemedicine Use And Outpatient Care During The COVID-19 Pandemic In The United States”, which examined outpatient and telemedicine visits across different patient demographics, specialties, and conditions between January and June 2020. The study found that 30.1% of all visits were provided via telemedicine, and usage was lower in areas with higher rates of poverty.

On December 29, JAMA published an article evaluating whether inequities are present in telemedicine use during the COVID-19 pandemic.  The study found that older patients, Asian patients, and non–English-speaking patients had lower rates of telemedicine use, and older patients, female patients, Black, Latinx, and poorer patients had less video use. The authors conclude that there are inequities that exist and the system must be intentionally designed to mitigate inequity.

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Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19

Since the beginning of the COVID-19 Public Health Emergency, the Trump Administration has issued an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. These temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. The goals of these actions are to 1) expand the healthcare system workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the community or from other states; 2) ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites (also known as CMS Hospital Without Walls); 3) increase access to telehealth in Medicare to ensure patients have access to physicians and other clinicians while keeping patients safe at home; 4) expand in-place testing to allow for more testing at home or in community based settings; and 5) put Patients Over Paperwork to give temporary relief from many paperwork, reporting and audit requirements so providers, health care facilities, Medicare Advantage and Part D plans, and States can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.

Medicare Telehealth

Clinicians can now provide more services to beneficiaries via telehealth so that clinicians can take care of their patients while mitigating the risk of the spread of the virus. Under the public health emergency, all beneficiaries across the country can receive Medicare telehealth and other communications technology-based services wherever they are located. Clinicians can provide these services to new or established patients. In addition, health care providers can waive Medicare copayments for these telehealth and other non-face-to-face services for beneficiaries in Original Medicare.

Under the CARES Act, CMS is waiving the requirements of section 1834(m)(1) of the ACT and 42 CFR § 410.78(a)(3) for use of interactive telecommunications systems to furnish telehealth services, to the extent they require use of video technology, for certain services. This waiver allows the use of audio-only equipment to furnish services described by the codes for audio-only telephone evaluation and management services, and behavioral health counseling and educational services. Unless provided otherwise, other services included on the Medicare telehealth services list must be furnished using, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site.

CMS is waiving the requirements of section 1834(m)(4)(E) of the Act and 42 CFR § 410.78 (b)(2) which specify the types of practitioners that may bill for their services when furnished as Medicare telehealth services from the distant site. The waiver of these requirements expands the types of health care professionals that can furnish distant site telehealth services to include all those that are eligible to bill Medicare for their professional services. As a result, a broader

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range of practitioners, such as physical therapists, occupational therapists, and speech language pathologists can use telehealth to provide many Medicare services.

Additionally, we are modifying the process to add services to the Medicare telehealth services list and instead, will consider adding appropriate services as they are requested, on a sub-regulatory basis as practitioners are actively learning how to use telehealth as broadly as possible. A complete list of all Medicare telehealth services can be found here: https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.

To enable services to continue while lowering exposure risk, clinicians can now provide the following additional services by telehealth:

• Emergency Department Visits, Levels 1-5 (CPT codes 99281-99285)
• Initial and Subsequent Observation and Observation Discharge Day Management (CPTcodes 99217-99220; CPT codes 99224-99226; CPT codes 99234-99236)
• Initial hospital care and hospital discharge day management (CPT codes 99221-99223;CPT codes 99238-99239)
• Initial nursing facility visits, All levels (Low, Moderate, and High Complexity) and nursingfacility discharge day management (CPT codes 99304-99306; CPT codes 99315-99316)
• Critical Care Services (CPT codes 99291-99292)
• Domiciliary, Rest Home, or Custodial Care services, New and Established patients (CPTcodes 99327-99328; CPT codes 99334-99337)
• Home Visits, New and Established Patient, All levels (CPT codes 99341-99345; CPTcodes 99347-99350)
• Inpatient Neonatal and Pediatric Critical Care, Initial and Subsequent (CPT codes 99468­99469; CPT codes 99471-99473; CPT codes 99475-99476)
• Initial and Continuing Intensive Care Services (CPT code 99477-994780)
• Care Planning for Patients with Cognitive Impairment (CPT code 99483)
• Group psychotherapy (CPT code 90853)
• Psychological and Neuropsychological Testing (CPT codes 96130-96133; CPT codes96136-96139)

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• Therapy Services, Physical and Occupational Therapy, All levels (CPT codes 97161­97168; CPT codes 97110, 97112, 97116, 97535, 97750, 97755, 97760, 97761, 92521­92524, 92507)
• Radiation Treatment Management Services (CPT codes 77427)

Remote Evaluations, Virtual Check-Ins & E-Visits

• Medicare patients may have a brief communication service with practitioners via anumber of communication technology modalities including synchronous discussion overa telephone or exchange of information through video or image. Clinicians can provideremote evaluation of patient video/images and virtual check-in services (HCPCS codesG2010, G2012) to both new and established patients. These services were previouslylimited to established patients.
• Licensed clinical social workers, clinical psychologists, physical therapists, occupationaltherapists, and speech language pathologists can provide e-visits. E-visits are non-face­to-face communications with their practitioner by using online patient portals. (HCPCScodes G2061-G2063).

Telephone Evaluation, Management/Assessment and Management Services, and Behavioral Health and Education Services

• A broad range of clinicians, including physicians, can now provide certain services bytelephone to their patients.
• Medicare payment for the telephone evaluation and management visits (CPT codes99441-99443) is equivalent to the Medicare payment for office/outpatient visits withestablished patients effective March 1, 2020.
• When clinicians are furnishing an evaluation and management (E/M) service that wouldotherwise be reported as an in-person or telehealth visit, using audio-only technology,practitioners may bill using these telephone E/M codes provided that it is appropriate tofurnish the service using audio-only technology and all of the required elements in theapplicable telephone E/M code (99441-99443) description are met.
• Using new waiver authority, CMS is also allowing many behavioral health and educationservices to be furnished via telehealth using audio-only communications. The full list oftelehealth services notes which services are eligible to be furnished via audio-onlytechnology, including the telephone evaluation and management visits:

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Remote Patient Monitoring

• Clinicians can provide remote patient monitoring services to both new and establishedpatients. These services can be provided for both acute and chronic conditions and cannow be provided for patients with only one disease. For example, remote patientmonitoring can be used to monitor a patient’s oxygen saturation levels using pulseoximetry. (CPT codes 99091, 99457-99458, 99473-99474, 99493-99494)
• Current CPT coding guidance states that the remote physiologic monitoring servicedescribed by CPT code 99454 (device(s) supply with daily recordings or programmedalerts transmission each 30 day(s)), cannot be reported for monitoring of less than 16days. For purposes of treating suspected COVID-19 infections, Medicare will allow theservice to be reported for shorter periods of time than 16 days as long as the other coderequirements are met.

Removal of Frequency Limitations on Medicare Telehealth

To better serve the patient population that would otherwise not have access to clinically appropriate in-person treatment, the following services no longer have limitations on the number of times they can be provided by Medicare telehealth:

• A subsequent inpatient visit can be furnished via Medicare telehealth, without thelimitation that the telehealth visit is once every three days (CPT codes 99231-99233);
• A subsequent skilled nursing facility visit can be furnished via Medicare telehealth,without the limitation that the telehealth visit is once every 30 days (CPT codes 99307­99310)
• Critical care consult codes may be furnished to a Medicare beneficiary by telehealthbeyond the once per day limitation (CPT codes G0508-G0509).

Other Medicare Telemedicine and Remote Patient Care

• For Medicare patients with End Stage Renal Disease (ESRD), clinicians no longer musthave one “hands on” visit per month for the current required clinical examination of thevascular access site.
• For Medicare patients with ESRD, we are exercising enforcement discretion on thefollowing requirement so that clinicians can provide this service via telehealth:individuals must receive a face-to-face visit, without the use of telehealth, at leastmonthly in the case of the initial 3 months of home dialysis and at least once every 3consecutive months after the initial 3 months.

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• To the extent that a National Coverage Determination (NCD) or Local Coverage Determination (LCD) would otherwise require a face-to-face visit for evaluations and assessments, clinicians would not have to meet those requirements during the public health emergency.
• Beneficiary consent should not interfere with the provision of non-face-to-face services. Annual consent may be obtained at the same time, and not necessarily before the time, that services are furnished.
• Physician visits: CMS is waiving the requirement in 42 CFR 483.30 for physicians and non-physician practitioners to perform in-person visits for nursing home residents and allow visits to be conducted, as appropriate, via telehealth options.
• Opioid Treatment Programs: Patient counseling and therapy services can be provided by telephone only in cases where the beneficiary does not have access to two-way interactive audio-video communication technology. Periodic patient assessments can be conducted via two-way interactive audio-video communication technology and may be provided by telephone only in cases where the beneficiary does not have access to two-way interactive audio-video communication technology.

Workforce

• Medicare Physician Supervision Requirements: For services requiring direct supervision by the physician or other practitioner, that physician supervision can be provided virtually using real-time audio/video technology.
• Supervision Requirements for Non-Surgical Extended Duration Therapeutic Services: Direct supervision is not required at the initiation of non-surgical extended duration therapeutic services provided in hospital outpatient departments and critical access hospitals. Instead, a general level of supervision can be provided for the entire duration of these services, so the supervising physician or practitioner is not required to be immediately available.
• Medicare Physician Supervision and Auxiliary Personnel: The physician can enter into a contractual arrangement that meets the definition of auxiliary personnel at 42 CFR 410.26, including with staff of another provider/supplier type, such as a home health agency (defined under § 1861(o) of the Act) or a qualified home infusion therapy supplier (defined under § 1861(iii)(3)(D)), or entities that furnish ambulance services, that can provide the staff and technology necessary to provide care that would ordinarily be provided incident to a physicians’ service (including services that are allowed to be performed via telehealth). In such instances, the provider/supplier would seek payment for any services provided by auxiliary personnel from the billing practitioner and would not submit claims to Medicare for such services.

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• Medicare Advanced Practice Nonphysician Practitioners: Nurse practitioner(NPs), clinical nurse specialists (CNSs), certified nurse-midwives (CNMs), and physician assistants (PAs) can supervise diagnostic tests as authorized under state law and licensure. These practitioners will need to continue the required statutory relationships with supervising or collaborating physicians.
• Physical Therapists and Occupational Therapists: The treating physical or occupational therapist who developed or is responsible for the maintenance program plan may delegate the performance of maintenance therapy services to a therapy assistant when clinically appropriate. This will free up the therapist to furnish other needed services during the PHE requiring his/her evaluative and assessment skills.
• Pharmacists: As auxiliary personnel, pharmacists can provide services incident to the professional services of a physician or nonphysician practitioner who bills Medicare Part B under the Physician Fee Schedule (PFS), if incident to rules are met and payment for the services is not made under Medicare Part D. The services must be provided in accordance with the pharmacist’s scope of practice and applicable state law.
• Teaching Physicians: Under the so-called primary care exception at section 415.174, a teaching physician may meet the requirement to review a visit furnished by a resident remotely using audio/video real time communications technology during the PHE. This flexibility can be helpful in the event that the teaching physician is not available to be present with the resident due to quarantine or social distancing.
• Physician Services: CMS is waiving 482.12(c)(1-2) and (4), which requires that Medicare patients in the hospital be under the care of a physician. This allows hospitals to use other practitioners, such as physician’s assistant and nurse practitioners, to the fullest extent possible. This waiver should be implemented in accordance with a state’s emergency preparedness or pandemic plan.
• National coverage determinations (NCDs) and Local Coverage Determinations (LCDs): To the extent NCDs and LCDs require a specific practitioner type or physician specialty to furnish or supervise a service, during this public health emergency, the Chief Medical Officer or equivalent of a hospital or facility will have the authority to make those staffing decisions.
• CMS is exercising enforcement discretion and will not enforce the current clinical indications in LCDs for therapeutic continuous glucose monitors during this public health emergency. This change is intended to permit more COVID-19 patients with diabetes to better monitor their glucose and adjust insulin doses from home.

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• Practitioner Locations: Temporarily waive Medicare and Medicaid’s requirements that physicians and non-physician practitioners be licensed in the state where they are providing services. State requirements will still apply. CMS waives the Medicare requirement that a physician or non-physician practitioner must be licensed in the State in which s/he is practicing for individuals for whom the following four conditions are met: 1) must be enrolled as such in the Medicare program, 2) must possess a valid license to practice in the State which relates to his or her Medicare enrollment, 3) is furnishing services – whether in person or via telehealth – in a State in which the emergency is occurring in order to contribute to relief efforts in his or her professional capacity, and 4) is not affirmatively excluded from practice in the State or any other State that is part of the 1135 emergency area. A physician or non-physician practitioner may seek an 1135-based licensure waiver from CMS by contacting the provider enrollment hotline for the Medicare Administrative Contractor that services their geographic area. This waiver does not have the effect of waiving State or local licensure requirements or any requirement specified by the State or a local government as a condition for waiving its licensure requirements.
• Modification of 60-day limit for Substitute Billing Arrangements (Locum Tenens): CMS is modifying the 60-day limit in section 1842(b)(6)(D)(iii) of the Social Security Act to allow a physician or physical therapist to use the same substitute for the entire time he or she is unavailable to provide services during the COVID-19 emergency plus an additional period of no more than 60 continuous days after the public health emergency expires. On the 61st day after the public health emergency ends (or earlier if desired), the regular physician or physical therapist must use a different substitute or return to work in his or her practice for at least one day in order to reset the 60-day clock. Without this flexibility, the regular physician or physical therapist generally could not use a single substitute for a continuous period of longer than 60 days, and would instead be required to secure a series of substitutes to cover sequential 60-day periods. The modified timetable applies to both types of substitute billing arrangements under Medicare fee-for-service (i.e., reciprocal billing arrangements and fee-for-time compensation arrangements, formerly known as locum tenens).

Note: Under the Medicare statute, only 1) physicians and 2) physical therapists who furnish outpatient physical therapy services in a health professional shortage area (HPSA), a medically underserved area (MUA), or a rural area can receive Medicare fee-for-service payment for services furnished by a substitute under a substitute billing arrangement. In addition, Medicare can pay for services under a substitute billing arrangement only when the regular physician or physical therapist is unavailable to provide the services. Finally, as provided by law, a regular physician or physical

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therapist who has been called or ordered to active duty as a member of a reserve component of the Armed Forces may continue to use the same substitute for an unlimited time even after the emergency ends.

•Provider Enrollment: CMS has established toll-free hotlines for physicians, non-physicianpractitioners and Part A certified providers and suppliers establishing isolation facilitiesto enroll and receive temporary Medicare billing privileges. CMS is providing thefollowing flexibilities for provider enrollment:

• Waive certain screening requirements.
  • Postpone all revalidation actions.
  • Allow licensed physicians and other practitioners to bill Medicare for servicesprovided outside of their state of enrollment.
  • Expedite any pending or new applications from providers.
  • Allow practitioners to render telehealth services from their home without reportingtheir home address on their Medicare enrollment while continuing to bill from yourcurrently enrolled location.
  • Allow opted-out practitioners to cancel their opt-out status early and enroll inMedicare to provide care to more patients.
• Student Documentation: In the CY 2020 Physician Fee Schedule (PFS) final rule, weadopted simplified medical record documentation requirements for physicians andcertain nonphysician practitioners to allow the billing clinician to review and verify,rather than redocument, information added to the medical record by any member ofthe health care team. During the public health emergency, this principle applies acrossthe spectrum of all Medicare-covered services, and will also apply to therapists so thatthey may review and verify, rather than redocument, notes added to the medical recordby any other member of the health care team, including therapy or other students.

Medicare COVID-19 Diagnostic Testing and Reporting

• COVID-19 Diagnostic Testing: Practitioners can be paid for assessment and specimencollection for COVID-19 testing using the level 1 evaluation and management code CPTcode 99211. In light of the public health emergency, Medicare will recognize this code tobe billed for all patients, not just established patients. This approach helps physicianpractices to operate testing sites during the PHE.

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• Physician or Practitioner Order for COVID-19 tests: Medicare will not require an order from a treating physician or nonphysician practitioner as a condition of Medicare coverage of COVID-19 testing during the PHE. CMS similarly removed these requirements for an influenza virus diagnostic laboratory test and any other diagnostic laboratory test that is necessary to establish or rule out a COVID-19 diagnosis. FDA requirements for a prescription and state requirements around ordering diagnostic tests would still apply. CMS has also removed certain documentation and recordkeeping requirements associated with orders for these COVID-19 diagnostic tests and related tests as these requirements would not be relevant in the absence of an order. CMS still expects laboratories to furnish the results of COVID-19 tests to the beneficiary. Consistent and regular reporting of all testing results to local officials is critical to public health management of the pandemic, we would expect any clinician or laboratory receiving results to report those results promptly consistent with state and local public health requirements, typically within 24 hours.

Patients Over Paperwork

• “Stark Law” Waivers: The physician self-referral law (also known as the “Stark Law”) prohibits a physician from making referrals for certain healthcare services payable by Medicare if the physician (or an immediate family member) has a financial relationship with the entity performing the service. There are statutory and regulatory exceptions, but in short, a physician cannot refer a patient to any entity with which he or she has a financial relationship. On March 30, 2020, CMS issued blanket waivers of certain provisions of the Stark Law regulations. These blanket waivers apply to financial relationships and referrals that are related to the COVID-19 emergency. The remuneration and referrals described in the blanket waivers must be solely related to COVID-19 Purposes, as defined in the blanket waiver document. Under the waivers, CMS will permit certain referrals and the submission of related claims that would otherwise violate the Stark Law. These flexibilities include:

• Hospitals and other health care providers can pay above or below fair market value for the personal services of a physician (or an immediate family member of a physician), and parties may pay below fair market value to rent equipment or purchase items or services. For example, a physician practice may be willing to rent or sell needed equipment to a hospital at a price that is below what the practice could charge another party. Or, a hospital may provide space on hospital grounds at no charge to a physician who is willing to treat patients who seek care at the hospital but are not appropriate for emergency department or inpatient care.
  • Health care providers can support each other financially to ensure continuity of health care operations. For example, a physician owner of a hospital may make a personal loan to the hospital without charging interest at a fair market rate so that the hospital can make payroll or pay its vendors.

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• Hospitals can provide benefits to their medical staffs, such as multiple daily meals, laundry service to launder soiled personal clothing, or child care services while the physicians are at the hospital and engaging in activities that benefit the hospital and its patients.
  • Health care providers may offer certain items and services that are solely related to COVID-19 Purposes (as defined in the waivers), even when the provision of the items or services would exceed the annual non-monetary compensation cap. For example, a home health agency may provide continuing medical education to physicians in the community on the latest care protocols for homebound patients with COVID-19, or a hospital may provide isolation shelter or meals to the family of a physician who was exposed to the novel coronavirus while working in the hospital’s emergency department.
  • Physician-owned hospitals can temporarily increase the number of their licensed beds, operating rooms, and procedure rooms, even though such expansion would otherwise be prohibited under the Stark Law. For example, a physician-owned hospital may temporarily convert observation beds to inpatient beds to accommodate patient surge during the COVID-19 pandemic in the United States.
  • Some of the restrictions regarding when a group practice can furnish medically necessary designated health services (DHS) in a patient’s home are loosened. For example, any physician in the group may order medically necessary DHS that is furnished to a patient by one of the group’s technicians or nurses in the patient’s home contemporaneously with a physician service that is furnished via telehealth by the physician who ordered the DHS.
  • Group practices can furnish medically necessary MRIs, CT scans or clinical laboratory services from locations like mobile vans in parking lots that the group practice rents on a part-time basis.
• National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) on Respiratory Related Devices, Oxygen and Oxygen Equipment, Home Infusion Pumps and Home Anticoagulation Therapy: CMS will not enforce clinical restrictions in certain NCDs and LCDs that would otherwise restrict coverage of these devices and services for COVID-19 patients during the public health emergency. Clinicians will have more flexibility in determining patient needs for respiratory related devices and equipment and the flexibility for more patients to manage their treatments at the home but will need to continue to document those decisions in the medical record.
  • Signature Requirements: CMS is waiving signature and proof of delivery requirements for Part B drugs and Durable Medical Equipment when a signature cannot be obtained because of the inability to collect signatures. Suppliers should document in the medical

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record the appropriate date of delivery and that a signature was not able to be obtained because of COVID-19.

• Changes to MIPS: We have made three updates to the Merit-based Incentive Payment System (MIPS) in the Quality Payment Program. Specifically, we are:

• Modifying the MIPS Extreme and Uncontrollable Circumstances policy – Individual MIPS eligible clinicians who have not submitted any MIPS data by the extended deadline of April 30, 2020 will automatically receive a neutral payment adjustment in 2021 (this automatic policy does not apply to groups or virtual groups). Alternatively, if a MIPS eligible clinician, group, or virtual group has submitted some MIPS data but is unable to complete their 2019 MIPS data submission because they have been adversely affected by the COVID-19 public health emergency, they can submit an application based on extreme and uncontrollable circumstances by April 30, 2020 at 8 p.m. ET to request reweighting of their MIPS performance categories for the 2019 performance year. These are important changes for clinicians who have been impacted by the COVID-19 outbreak and may be unable to submit their MIPS data during the current submission period;
  • Adding one new Improvement Activity for the CY 2020 performance period that, if selected, would provide high-weighted credit for clinicians within the MIPS Improvement Activities performance category. In order to receive credit for this activity, a MIPS eligible clinician must participate in a clinical trial utilizing a drug or biological product to treat a patient with COVID-19 and report their findings through a clinical data repository or clinical data registry for the duration of their study. This would help contribute to a clinician’s overall MIPS final score, while providing important data to help treat patients and address the current COVID­19 pandemic; and
  • Delaying the implementation of the Qualified Clinical Data Registry (QCDR) measure testing and data collection policies by 1 year. Both QCDR measure approval criteria necessitate that QCDRs collect data from clinicians in order to assess the measure, and we anticipate that QCDRs may be unable to collect, and clinicians unable to submit, data on QCDR measures due to prioritizing the care of COVID-19 patients.
• Accelerated/Advance Payments: In order to provide additional cash flow to healthcare providers and suppliers impacted by COVID-19, CMS expanded and streamlined the Accelerated and Advance Payments Program, which provided conditional partial payments to providers and suppliers to address disruptions in claims submission and/or claims processing subject to applicable safeguards for fraud, waste and abuse. Under this program, CMS made successful payment of over $100 billion to healthcare providers and suppliers. As of April 26, 2020, CMS is reevaluating all pending and new

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applications for the Accelerated Payment Program and has suspended the Advance Payment Program, in light of direct payments made available through the Department of Health & Human Services’ (HHS) Provider Relief Fund. Distributions made through the Provider Relief Fund do not need to be repaid. For providers and suppliers who have received accelerated or advance payments related to the COVID-19 Public Health Emergency, CMS will not pursue recovery of these payments until 120 days after the date of payment issuance. Providers and suppliers with questions regarding the repayment of their accelerated or advance payment(s) should contact their appropriate Medicare Administrative Contractor (MAC).

Medicare appeals in Fee for Service, Medicare Advantage (MA) and Part D

• CMS is allowing Medicare Administrative Contractors (MACs) and Qualified Independent Contractor (QICs) in the FFS program 42 CFR 405.942 and 42 CFR 405.962 and MA and Part D plans, as well as the Part C and Part D Independent Review Entity (IREs), 42 CFR 562, 42 CFR 423.562, 42 CFR 422.582 and 42 CFR 423.582 to allow extensions to file an appeal;
• CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and the Part C and Part D IREs to waive requirements for timeliness for requests for additional information to adjudicate appeals; MA plans may extend the timeframe to adjudicate organization determinations and reconsiderations for medical items and services (but not Part B drugs) by up to 14 calendar days if: the enrollee requests the extension; the extension is justified and in the enrollee’s interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization’s decision to deny an item or service; or, the extension is justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee’s interest 42 CFR § 422.568(b)(1)(i), § 422.572(b)(1) and § 422.590(f)(1);
• CMS is allowing MACs and QICs in the FFS program 42 C.F.R 405.910 and MA and Part D plans, as well as the Part C and Part D IREs to process an appeal even with incomplete Appointment of Representation forms 42 CFR § 422.561, 42 CFR § 423.560. However, any communications will only be sent to the beneficiary;
• CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs to process requests for appeal that don’t meet the required elements using information that is available 42 CFR § 422.562, 42 CFR § 423.562.
• CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs, 42 CFR 422.562, 42 CFR

423.562 to utilize all flexibilities available in the appeal process as if good cause requirements are satisfied.

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Additional Guidance

• The Interim Final Rules and waivers can be found at: https://www.cms.gov/about­cms/emergency-preparedness-response-operations/current-emergencies/coronavirus­waivers.
• CMS has released guidance to providers related to relaxed reporting requirements forquality reporting programs at https://www.cms.gov/files/document/guidance-memo­exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.

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Hospitals: CMS Flexibilities to Fight COVID-19

The Trump Administration is issuing an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. Made possible by President Trump’s recent emergency declaration and emergency rule making, these temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. The goals of these actions are to 1) expand the healthcare system workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the community or from other states; 2) ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites (also known as CMS Hospital Without Walls); 3) increase access to telehealth in Medicare to ensure patients have access to physicians and other clinicians while keeping patients safe at home; 4) expand in-place testing to allow for more testing at home or in community based settings; and 5) put Patients Over Paperwork to give temporary relief from many paperwork, reporting and audit requirements so providers, health care facilities, Medicare Advantage and Part D plans, and States can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.

Telehealth

• •Hospital Outpatient Services Accompanying Professional Services Furnished ViaTelehealth: When a physician or nonphysician practitioner who typically furnishesprofessional services in the hospital outpatient department furnishes telehealth servicesduring the COVID-19 PHE, they bill with a hospital outpatient place of service since thatis likely where the services would have been furnished if not for the COVID-19 PHE. Thephysician or practitioner is paid for the service under the PFS at the facility rate, whichdoes not include payment for resources such as clinical staff, supplies, or officeoverhead since those things are usually supplied by the hospital outpatient department.During the COVID-19 PHE, if the beneficiary’s home or temporary expansion site isconsidered to be a provider-based department of the hospital, and the beneficiary isregistered as an outpatient of the hospital for purposes of receiving telehealth servicesbilled by the physician or practitioner, the hospital may bill under the PFS for theoriginating site facility fee associated with the telehealth service.

CMS Hospital Without Walls (Temporary Expansion Sites)

• •Hospitals Able to Provide Care in Temporary Expansion Sites: As part of the CMS HospitalWithout Walls initiative, hospitals can provide hospital services in other healthcarefacilities and sites that would not otherwise be considered to be part of a healthcarefacility; or can set up temporary expansion sites to help address the urgent need toincrease capacity to care for patients. In the absence of waivers, hospitals are requiredto provide services to patients within their hospital departments. Hospitals have sharedconcerns about capacity for treating patients during the COVID-19 PHE, especially thoserequiring ventilator and intensive care services. CMS is providing additional flexibilities

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• for hospitals to create surge capacity by allowing them to provide room and board, nursing, and other hospital services at remote locations or sites not normally considered parts of healthcare facilities, such as hotels or community facilities. This flexibility will allow hospitals to separate COVID-19 positive patients from other non-COVID-19 patients to help efforts around infection control and preservation of personal protective equipment (PPE). For example, for the duration of the COVID-19 PHE, CMS is allowing hospitals to screen patients at offsite locations, and furnish inpatient and outpatient services at temporary expansion sites. Hospitals would still be expected to control and oversee the services provided at an alternative location. CMS also is offering some additional flexibilities to furnish inpatient services under arrangements during the PHE.

• • Under the Hospitals without Walls initiative, CMS relaxed certain conditions of participation (CoPs) and provider-based rules for hospital operations to maximize hospitals ability to focus on patient care. The same initiative also allows currently enrolled ambulatory surgical centers (ASCs), to temporarily enroll as hospitals and to provide hospital services to help address the urgent need to increase hospital capacity to take care of patients. Other interested entities, such as independent licensed emergency departments, could pursue enrolling as a hospital during the PHE. ASCs that wish to enroll to receive temporary billing privileges as a hospital should call the COVID-19 Provider Enrollment Hotline to reach the contractor that serves their jurisdiction, and then will complete and sign an attestation form specific to the COVID-19 PHE. See https://www.cms.gov/files/document/provider-enrollment-relief-faqs-covid-19.pdf for additional information.

• • Off Site Patient Screening: CMS is partially waiving the enforcement of section 1867(a) of the Social Security Act (the Emergency Medical Treatment and Active Labor Act, or EMTALA). This will allow hospitals, psychiatric hospitals, and critical access hospitals (CAHs) to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19, so long as it is not inconsistent with the state emergency preparedness or pandemic plan.

• o 42 CFR §482.13(d)(2) with respect to timeframes in providing a copy of a medical record.
  • 42 CFR §482.13(h) related to patient visitation, including the requirement to have written policies and procedures on visitation of patients who are in COVID-19 isolation and quarantine processes.

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• • Physical Environment: CMS waived certain requirements under the conditions at 42 CFR §482.41 and §485.623 to allow for flexibilities during hospital, psychiatric hospital, and CAH surges. CMS will permit non-hospital buildings/space to be used for patient care and quarantine sites, provided that the location is approved by the State (ensuring safety and comfort for patients and staff are sufficiently addressed). This allows for increased capacity and promotes appropriate cohorting of COVID-19 patients.
  • o Adopting a temporary extraordinary circumstances relocation exception policy for on-campus PBDs and excepted off-campus PBDs that are relocating off-campus during the COVID-19 PHE. Under our existing extraordinary relocation exception policy, only relocating off-campus PBDs are eligible to request this exception.
  • Streamlining the process during the COVID-19 PHE for relocating PBDs to seek the extraordinary circumstances exception so they can start seeing patients and billing for services immediately in the relocated PBD.
  • Allowing PBDs to relocate into more than one PBD location, and allowing PBDs to partially relocate while still maintaining the original location. Hospitals can relocate PBDs to the patient’s home and continue to receive the full OPPS payment amount under the extraordinary circumstances relocation exception policy.

Note regarding Payment for Certain Provider-Based Departments (PBDs) During the PHE: Hospital waivers do not impact the payment rates for covered hospital outpatient items and services, including whether the PBD is paid under the Physician Fee Schedule (PFS)- equivalent rate or under the Outpatient Prospective Payment System (OPPS) under Section 603 of the Bipartisan Budget Act of 2015.

Under section 603 rules, most new off-campus PBDs are typically paid at the Medicare PFS-equivalent rate instead of the rate determined under the OPPS. CMS has determined through rulemaking that the PFS-equivalent rate to be 40% of the OPPS rate. Most PBDs that relocate are also subject to the lower rate, unless they are eligible to seek and are approved for an extraordinary circumstances relocation exception.

CMS has made several changes to support hospitals so they can more effectively respond to the COVID-19 PHE. These changes include: 4/29/2020 4

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Teaching Hospitals, Teaching Physicians and Medical Residents: CMS Flexibilities to Fight COVID-19

Since the beginning of the COVID-19 Public Health Emergency, the Trump Administration has issued an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. These temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. The goals of these actions are to 1) expand the healthcare system workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the community or from other states; 2) ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites (also known as CMS Hospital Without Walls); 3) increase access to telehealth in Medicare to ensure patients have access to physicians and other clinicians while keeping patients safe at home; 4) expand in-place testing to allow for more testing at home or in community based settings; and 5) put Patients Over Paperwork to give temporary relief from many paperwork, reporting and audit requirements so providers, health care facilities, Medicare Advantage and Part D plans, and States can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.

Workforce

• • Application of Teaching Physician Regulations: Under current rules, Medicare payment is made for services furnished by a teaching physician involving residents only if the physician is physically present for the key portion of the service or procedure or the entire procedure, where applicable. During the COVID-19 PHE, teaching physicians may use audio/video real time communications technology to interact with the resident through virtual means, which would meet the requirement that they be present for the key portion of the service, including when the teaching physician involves the resident in furnishing Medicare Telehealth services. Teaching physicians involving residents in providing care at primary care centers can provide the necessary direction, management and review for the resident’s services using audio/video real time communications technology. Residents furnishing services at primary care centers may furnish an expanded set of services to beneficiaries, including levels 4-5 of an office/outpatient evaluation and management (E/M) visit, telephone E/M, care management, and communication technology-based services. These flexibilities do not apply in the case of surgical, high risk, interventional, or other complex procedures, services performed through an endoscope, and anesthesia services. This allows teaching hospitals to maximize their workforce to safely take care of patients.

• • Resident Moonlighting: Under current rules, Medicare considers the services of residents that are not related to their approved graduate medical education programs and performed in the outpatient department or the emergency department of a hospital as separately billable physicians’ services. During the COVID-19 PHE, Medicare

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• also considers the services of residents that are not related to their approved GME programs and furnished to inpatients of a hospital in which they have their training program as separately billable physicians’ services.

• • Counting of Resident Time at Alternate Locations: Existing regulations have specific rules on when a hospital may count a resident for purposes of Medicare direct graduate medical education (DGME) payments or indirect medical education (IME) payments. Normally, if the resident is performing activities with the scope of his/her approved program in his/her own home, or a patient’s home, the hospital may not count the resident. During the PHE, a hospital that is paying the resident’s salary and fringe benefits for the time that the resident is at home or in a patient’s home, but performing duties within the scope of the approved residency program and meets appropriate physician supervision requirements can claim that resident for IME and DGME purposes. This allows medical residents to perform their duties in alternate locations, including their own home or a patient’s home, so long as such activities meet appropriate physician supervision requirements.
• • Graduate Medical Education (GME) Residents Training in Other Hospitals: During the COVID-19 PHE, a teaching hospital that sends residents to other hospitals will be able to continue to claim those residents in the teaching hospital’s IME and DGME FTE resident counts, if certain requirements are met. Those requirements include that 1) the teaching hospital sends the resident to the other hospital in response to the COVID-19 pandemic; 2) the time spent by the resident training at the other hospital is in lieu of time that would have been spent training at the sending hospital; and 3) the time that the resident spent training immediately prior to and/or subsequent to the time frame that the COVID-19 PHE was in effect was included in the FTE count for the sending hospital. Moreover, the presence of residents in non-teaching hospitals will not trigger establishment of IME and/or DGME FTE resident caps at those non-teaching hospitals. Specifically, for DGME, the presence of residents in non-teaching hospitals will not trigger establishment of PRAs at those non-teaching hospitals.

• • IME Payments Held Harmless for Temporary Increase in Beds: During the COVID-19 PHE, CMS will hold teaching hospitals harmless from a reduction in IME payments due to beds temporarily added during the COVID-19 PHE by not considering such beds when determining IME payments.

• • Inpatient Psychiatric Facilities (IPFs) Teaching Status Adjustment Payments: To ensure that teaching IPFs can alleviate bed capacity issues by taking patients from the inpatient acute care hospitals without being penalized by lower teaching status adjustments, we are freezing the IPFs’ teaching status adjustment payments at their values prior to the PHE. For the duration of the COVID-19 PHE, a teaching IPF’s teaching status adjustment payments will be the same as they were on the day before the COVID-19 PHE was declared.

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• • Sterile Compounding: CMS is waiving hospital sterile compounding requirements to allow used face masks to be removed and retained in the compounding area to be re-donned and reused during the same work shift in the compounding area only. This will conserve scarce face mask supplies. CMS will not be reviewing the use and storage of facemasks under these requirements.

• • Medical Staff Requirements: CMS is waiving the Medical Staff requirements at 42 CFR §482.22(a)(1)-(4) to allow for physicians whose privileges will expire to continue practicing at the hospital and for new physicians to be able to practice in the hospital before full medical staff/governing body review and approval to address workforce concerns related to COVID-19.

• • Physician services: CMS is waiving 482.12(c)(1)–(2) and §482.12(c)(4), which requires that Medicare patients be under the care of a physician, and that a physician be on call at all times. This allows hospitals to use other practitioners, such as physician’s assistant and nurse practitioners, to the fullest extent possible. This waiver should be implemented so long as they are not inconsistent with a state’s emergency preparedness or pandemic plan.

• • Anesthesia services. CMS is waiving the requirements at 42 CFR 482.52(a)(5),42 CFR 485.639(c)(2), and 42 CFR 416.42 (b)(2) that a certified registered nurse anesthetist (CRNA) is under the supervision of a physician. CRNA supervision will be at the discretion of the hospital or Ambulatory Surgical Center (ASC), and state law. This waiver applies to hospitals, CAHs, and ASCs. These waivers will allow CRNAs to function to the fullest extent of their licensure, and should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan.

• • Respiratory care services: We are waiving the requirement at 42 CFR 482.57(b)(1) that hospitals designate in writing the personnel qualified to perform specific respiratory care procedures and the amount of supervision required for personnel to carry out specific procedures. These flexibilities should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan. Not being required to designate these professionals in writing will allow qualified professionals to operate to the fullest extent of their licensure and training in providing patient care for respiratory illnesses.

• • CAH Personnel qualifications: CMS is waiving the minimum personnel qualifications for clinical nurse specialist, nurse practitioners, and physician assistants described at 42 CFR 485.604 (a)(2), 42 CFR 485.604 (b)(1-3), and 42 C.F.R 485.604 (c)(1-3). Clinical Nurse Specialists, Nurse Practitioners, and Physician Assistants will still have to meet state requirements for licensure and scope of practice, but not additional Federal requirements that may exceed State requirements. This will give States and facilities more flexibility in using clinicians in these roles to meet increased demand. These

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• flexibilities should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan.

• • CAH staff licensure: CMS is deferring to staff licensure, certification, or registration to State law by waiving the requirement at 42 CFR 485.608(d) that staff of the CAH be licensed, certified, or registered in accordance with applicable Federal, State, and local laws and regulations. The CAH and its staff must still be in compliance with applicable Federal, State and Local laws and regulations, and all patient care must be furnished in compliance with State and local laws and regulations. This waiver would defer all licensure, certification, and registration requirements for CAH staff to the state, which would add flexibility where Federal requirements are more stringent. These flexibilities should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan.

CMS Hospital Without Walls (Temporary Expansion Sites)

• • Hospitals Able to Provide Inpatient Care in Temporary Expansion Sites: As part of the CMS Hospital Without Walls initiative, hospitals can provide hospital services in other healthcare facilities and sites not currently considered to be part of a healthcare facility or set up temporary expansion sites to help address the urgent need to increase capacity to care for patients. Previously, hospitals were required to provide services to patients within their hospital departments, and have shared concerns about capacity for treating patients during the COVID-19 Public Health Emergency, especially those requiring ventilator and intensive care services. CMS is providing additional flexibilities for hospitals to create surge capacity by allowing them to provide room and board, nursing, and other hospital services at remote locations or sites not considered part of a healthcare facility such as hotels or community facilities. This flexibility will allow hospitals to separate COVID-19 positive patients from other non-COVID-19 patients to help efforts around infection control and preservation of personal protective equipment (PPE). For example, for the duration of the Public Health Emergency, CMS is allowing hospitals to screen patients at offsite locations, furnish inpatient and outpatient services at temporary expansion sites. Hospitals would still be expected to control and oversee the services provided at an alternative location.

• • Relaxing Conditions of Participation. Under an additional initiative, CMS is relaxing certain conditions of participation (CoPs) for hospital operations to maximize hospitals ability to focus on patient care. The same initiative will also allow currently enrolled ambulatory surgical centers (ASCs), to temporarily enroll as hospitals and to provide hospital services to help address the urgent need to increase hospital capacity to take care of patients. Other interested entities, such as freestanding emergency departments, could pursue enrolling as an ASC and then pursue converting their enrollment to hospital during the PHE. ASCs that wish to enroll to receive temporary billing privileges as a hospital should call the COVID-19 Provider Enrollment Hotline to reach the contractor that serves their jurisdiction, and then will complete and sign an

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• attestation form specific to the COVID-19 PHE. This document will be made available shortly. See https://www.cms.gov/files/document/provider-enrollment-relief-faqs-covid-19.pdf for additional information.

• • Off Site Patient Screening: CMS is waiving the enforcement of section 1867(a) of the Social Security Act (the Emergency Medical Treatment and Labor Act, or EMTALA). This will allow hospitals, psychiatric hospitals, and critical access hospitals (CAHs) to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19, so long as it is not inconsistent with the state emergency preparedness or pandemic plan.

• o 42 CFR §482.13(d)(2) with respect to timeframes in providing a copy of a medical record.
  • 42 CFR §482.13(h) related to patient visitation, including the requirement to have written policies and procedures on visitation of patients who are in COVID-19 isolation and quarantine processes.

• • Physical Environment: CMS is waiving certain requirements under the conditions at 42 CFR §482.41 and §485.623 to allow for flexibilities during hospital, psychiatric hospital, and CAH surges. CMS will permit non-hospital buildings/space to be used for patient care and quarantine sites, provided that the location is approved by the State (ensuring safety and comfort for patients and staff are sufficiently addressed). This allows for increased capacity and promotes appropriate cohorting of COVID-19 patients.
• • Temporary Expansion Sites. For the duration of the PHE related to COVID-19, CMS is waiving certain requirements under the Medicare conditions of participation at 42 CFR §482.41 and §485.623 (as noted above) and the provider-based department requirements at 42 CFR §413.65 to allow hospitals to establish and operate as part of the hospital any location meeting the conditions of participation for hospitals in operation during the PHE. This waiver also allows hospitals to change the status of their current provider-based department locations to the extent necessary to address the needs of hospital patients as part of the State or local pandemic plan. This waiver will enable hospitals to meet the needs of Medicare beneficiaries. CMS also is offering some additional flexibilities to furnish inpatient services under arrangements.

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• • Critical Access Hospital Length of Stay: CMS is waiving the Medicare requirements that Critical Access Hospitals (CAHs) limit the number of beds to 25, and that the length of stay be limited to 96 hours under the Medicare conditions of participation regarding number of beds and length of stay at 42 CFR §485.620.

• • CAH Status and location: CMS is waiving the requirement at 485.610(b) that the CAH be located in a rural area or an area being treated as rural, allowing the CAHs flexibility in the establishment of surge site locations. Waiving the requirement at 485.610(e) regarding off-campus and co-location requirements allows the CAH flexibility in establishing off-site locations. In an effort to facilitate the establishment of CAHs without walls, these waivers will remove restrictions on CAHs regarding their rural location and their location relative to other hospitals and CAHs. These flexibilities should be implemented so long as they are not inconsistent with State or emergency or pandemic plan.

• • Housing Acute Care Patients in Excluded Distinct Part Units: CMS is waiving requirements to allow acute care hospitals to house acute care inpatients in excluded distinct part units, where the distinct part unit’s beds are appropriate for acute care inpatients. The Inpatient Prospective Payment System (IPPS) hospital should bill for the care and annotate the patient’s medical record to indicate the patient is an acute care inpatient being housed in the excluded unit because of capacity issues related to the disaster or emergency.

• • Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital: CMS is waiving requirements to allow acute care hospitals with excluded distinct part inpatient psychiatric units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part psychiatric unit to an acute care bed and unit. The hospital should continue to bill for inpatient psychiatric services under the Inpatient Psychiatric Facility Prospective Payment System (IPF PPS) for such patients and annotate the medical record to indicate the patient is a psychiatric inpatient being cared for in an acute care bed because of capacity or other exigent circumstances related to the COVID-19 Public Health emergency. This waiver may be utilized where the hospital’s acute care beds are appropriate for psychiatric patients and the staff and environment are conducive to safe care. For psychiatric patients, this includes assessment of the acute care bed and unit location to ensure those patients at risk of harm to self and others are safely cared for.

• • Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a Hospital: CMS is waiving requirements to allow acute care hospitals with excluded distinct part inpatient Rehabilitation units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part rehabilitation unit to an acute care bed and unit. The hospital should continue to bill for inpatient rehabilitation services under the Inpatient Rehabilitation Facility Prospective Payment System for such

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• patients and annotate the medical record to indicate the patient is a rehabilitation inpatient being cared for in an acute care bed because of capacity or other exigent circumstances related to the disaster or emergency. This waiver may be utilized where the hospital’s acute care beds are appropriate for providing care to rehabilitation patients and such patients continue to receive intensive rehabilitation services.

• • Telemedicine: CMS is waiving the provisions related to telemedicine for hospitals and CAHs at 42 CFR 482.12(a)(8)-(9) and 42 CFR 485.616(c), making it easier for telemedicine services to be furnished to the hospital’s patients through an agreement with an off-site hospital. This allows for increased access to necessary care for hospital and CAH patients, including access to specialty care.

Patients Over Paperwork

• o Hospitals and other health care providers can pay above or below fair market value for the personal services of a physician (or an immediate family member of a physician), and parties may pay below fair market value to rent equipment or purchase items or services. For example, a physician practice may be willing to rent or sell needed equipment to a hospital at a price that is below what the practice could charge another party. Or, a hospital may provide space on hospital grounds at no charge to a physician who is willing to treat patients who seek care at the hospital but are not appropriate for emergency department or inpatient care.
  • Health care providers can support each other financially to ensure continuity of health care operations. For example, a physician owner of a hospital may make a personal loan to the hospital without charging interest at a fair market rate so that the hospital can make payroll or pay its vendors.
  • Hospitals can provide benefits to their medical staffs, such as multiple daily meals, laundry service to launder soiled personal clothing, or child care services while the

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• • Health care providers may offer certain items and services that are solely related to COVID-19 Purposes (as defined in the waivers), even when the provision of the items or services would exceed the annual non-monetary compensation cap. For example, a home health agency may provide continuing medical education to physicians in the community on the latest care protocols for homebound patients with COVID-19, or a hospital may provide isolation shelter or meals to the family of a physician who was exposed to the novel coronavirus while working in the hospital’s emergency department.
  • Physician-owned hospitals can temporarily increase the number of their licensed beds, operating rooms, and procedure rooms, even though such expansion would otherwise be prohibited under the Stark Law. For example, a physician-owned hospital may temporarily convert observation beds to inpatient beds to accommodate patient surge during the COVID-19 pandemic in the United States.
  • Some of the restrictions regarding when a group practice can furnish medically necessary designated health services (DHS) in a patient’s home are loosened. For example, any physician in the group may order medically necessary DHS that is furnished to a patient by one of the group’s technicians or nurses in the patient’s home contemporaneously with a physician service that is furnished via telehealth by the physician who ordered the DHS.
  • Group practices can furnish medically necessary MRIs, CT scans or clinical laboratory services from locations like mobile vans in parking lots that the group practice rents on a part-time basis.

• • Verbal Orders: CMS is waiving the requirements of 42 CFR §482.23, §482.24 and §485.635(d)(3) to allow for additional flexibilities related to verbal orders where read-back verification is still required but authentication may occur later than 48 hours. This will allow for more efficient treatment of patients in a surge situation.

• • Reporting Requirements: CMS is waiving reporting requirements at §482.13(g) (1)(i)-(ii) which require hospitals to report patients in an intensive care unit whose death is caused by their disease process but who required soft wrist restraints to prevent pulling tubes/IVs may be reported later than close of business next business day, provided any death where the restraint may have contributed is continued to be reported within standard time limits. Due to current hospital surge, we are waiving this requirement to ensure that hospitals are focusing on increased care demands and patient care.

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• • Limit Discharge Planning for Hospital and CAHs: To allow hospitals and CAHs more time to focus on increasing care demands, discharge planning will focus on ensuring that patients are discharged to an appropriate setting with the necessary medical information and goals of care. CMS is waiving detailed regulatory requirements to provide information regarding discharge planning, as outlined in 42 CFR §482.43(a)(8), §482.61(e), and 485.642(a)(8). The hospital, psychiatric hospital, and CAH must assist patients, their families, or the patient’s representative in selecting a post-acute care provider by using and sharing data that includes, but is not limited to, home health agency (HHA), skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), and long term care hospital (LTCH) data on quality measures and data on resource use measures. The hospital must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences. During this public health emergency, a hospital may not be able to assist patients in using quality measures and data to select a nursing home or home health agency, but must still work with families to ensure that the patient discharge is to a post-acute care provide that is able to meet the patient’s care needs.

• • Modify Discharge Planning for Hospitals: Patients must continue to be discharged to an appropriate setting with the necessary medical information and goals of care. To address the COVID-19 pandemic, CMS is waiving certain requirements related to hospital discharge planning for post-acute care services at 42 CFR §482.43(c), so as to expedite the safe discharge and movement of patients among care settings, and to be responsive to fluid situations in various areas of the country. CMS is waiving certain requirements for those patients discharged home and referred for HHA services, or for those patients transferred to a SNF for post-hospital extended care services, or transferred to an IRF or LTCH for specialized hospital services. For example, a patient may not be able to receive a comprehensive list of nursing homes in the geographic area, but must still be discharged to a nursing home that is available to provide the care that is need by the patient.

• • Medical Records: CMS is waiving 42 CFR §482.24(a) through (c), which cover the subjects of the organization and staffing of the medical records department, requirements for the form and content of the medical record, and record retention requirements. CMS is waiving these requirements under 42 CFR §482.24(c)(4)(viii) and §485.638(a)(4)(iii) related to medical records to allow flexibility in completion of medical records within 30 days following discharge and for CAHs that all medical records must be promptly completed. This flexibility will allow clinicians to focus on the patient care at the bedside during the pandemic.

• • Flexibility in Patient Self Determination Act Requirements (Advance Directives): CMS is waiving the requirements at section 1902(a)(58) and 1902(w)(1)(A) for Medicaid, 1852(i) (for Medicare Advantage), and 1866(f) and 42 CFR 489.102 for Medicare, which require hospitals and CAHs to provide information about its advance directive policies to

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• patients. We are waiving this requirement to allow for staff to more efficiently deliver care to a larger number of patients.

• • Extension for Inpatient Prospective Payment System (IPPS) Wage Index Occupational Mix Survey Submission: CMS collects data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program. CMS is currently granting an extension for data submission for hospitals nationwide affected by COVID-19 until August 3, 2020. If hospitals encounter difficulty meeting this extended deadline date, hospitals should communicate their concerns to CMS via their MAC, and CMS may consider an additional extension if CMS determines it is warranted.

• • Utilization review. CMS is waiving these requirements at 42 CFR §482.1(a)(3) and 42 C.F.R §482.30 that requires that hospitals participating in Medicare and Medicaid to have a utilization review plan that meets specified requirements. CMS is waiving the entire Utilization Review CoP at §482.30, which requires that a hospital must have a utilization review (UR) plan with a UR committee that provides for review of services furnished to Medicare and Medicaid beneficiaries to evaluate the medical necessity of the admission, duration of stay, and services provided. These flexibilities should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan. Removing these administrative requirements will allow hospitals to focus more resources on providing direct patient care.
• • Quality assessment and performance improvement program. CMS is waiving 482.21(a)-(d) and (f), and 485.641(a), (b), and (d), which provide details the scope of the program, the incorporation, and setting priorities for the program’s performance improvement activities, and integrated QAPI programs (for hospitals that are a part of a hospital system). These flexibilities, which apply to both hospitals and CAHs, should be implemented so long as they are not inconsistent with a state’s emergency preparedness or pandemic plan. We expect any improvements to the plan to focus on the Public Health Emergency. While this waiver decreases burden associated with the development of a hospital or CAH QAPI program, the requirement that hospitals and CAHs maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program will remain. This waiver applies to both hospitals and CAHs.

• • Nursing services: CMS is waiving the provision at 42 CFR 482.23(b)(4), 42 CFR 482.23(b)(7), and 485.635(d)(4), which requires the nursing staff to develop and keep current a nursing care plan for each patient, and the provision that requires the hospital to have policies and procedures in place establishing which outpatient departments are not required under to have a registered nurse present. These waivers allow nurses increased time to meeting the clinical care needs of each patient and allows for the provision of nursing care to an increased number of patients. In addition, we expect that

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• hospitals will need relief for the provision of inpatient services and as a result, the requirement to establish nursing-related policies and procedures for outpatient departments is likely unnecessary. These flexibilities apply to both hospitals and CAHs, and should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan.

• • Food and dietetic service: CMS is waiving the requirement at 42 CFR 482.28(b)(3) to have a current therapeutic diet manual approved by the dietitian and medical staff readily available to all medical, nursing, and food service personnel. Such manuals would not need to be maintained at surge capacity sites. These flexibilities should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan. Removing these administrative requirements will allow hospitals to focus more resources on providing direct patient care.

• • Written policies and procedures for appraisal of emergencies at off campus hospital departments: CMS is waiving 482.12(f)(3) related to Emergency services, with respect to the surge facility(ies) only, such that written policies and procedures for staff to use when evaluating emergencies are not required for surge facilities. This removes the burden on facilities to develop and establish additional policies and procedures at their surge facilities or surge sites related to the assessment, initial treatment and referral of patients. These flexibilities should be implemented so long as they are not inconsistent with a state’s emergency preparedness or pandemic plan.
• • Emergency preparedness policies and procedures: CMS is waiving 482.15(b) and 485.625(b), which requires the hospital and CAH to develop and implement emergency preparedness policies and procedures, and 482.15(c)(1)-(5) and 485.625(c)(1)-(5) which requires that the emergency preparedness communication plans for hospitals and CAHs to contain specified elements with respect to the surge site. The requirement under the communication plan requires hospitals and CAHs to have specific contact information for staff, entities providing services under arrangement, patients’ physicians, other hospitals and CAHs, and volunteers. This would not be an expectation for temporary expansion site. This waiver removes the burden on facilities to establish these policies and procedures for their surge facilities or surge sites.
• • Signature Requirements: CMS is waiving signature and proof of delivery requirements for Part B drugs and Durable Medical Equipment when a signature cannot be obtained because of the inability to collect signatures. Suppliers should document in the medical record the appropriate date of delivery and that a signature was not able to be obtained because of COVID-19.
• • Accelerated/Advance Payments: In order to provide additional cash flow to healthcare providers and suppliers impacted by COVID-19, CMS expanded and streamlined the Accelerated and Advance Payments Program, which provided conditional partial

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• payments to providers and suppliers to address disruptions in claims submission and/or claims processing subject to applicable safeguards for fraud, waste and abuse. Under this program, CMS made successful payment of over $100 billion to healthcare providers and suppliers. As of April 26, 2020, CMS is reevaluating all pending and new applications for the Accelerated Payment Program and has suspended the Advance Payment Program, in light of direct payments made available through the Department of Health & Human Services’ (HHS) Provider Relief Fund. Distributions made through the Provider Relief Fund do not need to be repaid. For providers and suppliers who have received accelerated or advance payments related to the COVID-19 Public Health Emergency, CMS will not pursue recovery of these payments until 120 days after the date of payment issuance. Providers and suppliers with questions regarding the repayment of their accelerated or advance payment(s) should contact their appropriate Medicare Administrative Contractor (MAC).

• • Cost Reporting: CMS is delaying the filing deadline of certain cost report due dates due to the COVID-19 outbreak. We are currently authorizing delay for the following fiscal year end (FYE) dates. CMS will delay the filing deadline of FYE 10/31/2019 cost reports due by March 31, 2020 and FYE 11/30/2019 cost reports due by April 30, 2020. The extended cost report due dates for these October and November FYEs will be June 30, 2020. CMS will also delay the filing deadline of the FYE 12/31/2019 cost reports due by May 31, 2020. The extended cost report due date for FYE 12/31/2019 will be July 31, 2020.

• • Provider Enrollment: CMS has established toll-free hotlines for all providers as well as the following flexibilities for provider enrollment:

• o Waive certain screening requirements.
• o Postpone all revalidation actions.
• o Expedite any pending or new applications from providers.

Medicare appeals in Fee for Service, Medicare Advantage (MA) and Part D

• • CMS is allowing Medicare Administrative Contractors (MACs) and Qualified Independent Contractor (QICs) in the FFS program 42 CFR 405.942 and 42 CFR 405.962 and MA and Part D plans, as well as the Part C and Part D Independent Review Entity (IREs), 42 CFR 562, 42 CFR 423.562, 42 CFR 422.582 and 42 CFR 423.582 to allow extensions to file an appeal;
• • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and the Part C and Part D IREs to waive requirements for timeliness for requests for additional information to adjudicate appeals; MA plans may extend the timeframe to adjudicate organization determinations and reconsiderations for medical items and services (but not Part B drugs) by up to 14 calendar days if: the enrollee requests the extension; the extension is justified and in the enrollee’s interest due to the need for

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• additional medical evidence from a noncontract provider that may change an MA organization’s decision to deny an item or service; or, the extension is justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee’s interest 42 CFR § 422.568(b)(1)(i), § 422.572(b)(1) and § 422.590(f)(1);

• • CMS is allowing MACs and QICs in the FFS program 42 C.F.R 405.910 and MA and Part D plans, as well as the Part C and Part D IREs to process an appeal even with incomplete Appointment of Representation forms 42 CFR § 422.561, 42 CFR § 423.560. However, any communications will only be sent to the beneficiary;
• • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs to process requests for appeal that don’t meet the required elements using information that is available 42 CFR § 422.562, 42 CFR § 423.562.
• • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs, 42 CFR 422.562, 42 CFR 423.562 to utilize all flexibilities available in the appeal process as if good cause requirements are satisfied.

Additional Guidance

• • The Interim Final Rules and waivers can be found at: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers .

• • CMS has released guidance to describe standards of practice and flexibilities within the current regulations for hospitals (including critical access hospitals and psychiatric hospitals) at https://www.cms.gov/files/document/qso-20-13-hospitalspdf.pdf-2.

• • CMS guidance also addresses hospital flexibilities under the Emergency Medical Treatment and Labor Act (EMTALA) to establish alternate testing and triage sites to address the pandemic at https://www.cms.gov/files/document/qso-20-15-hospitalcahemtala.pdf.

• • CMS has released guidance to providers related to relaxed reporting requirements for quality reporting programs at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf

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Long Term Care Facilities (Skilled Nursing Facilities and/or Nursing Facilities): CMS Flexibilities to Fight COVID-19

Since the beginning of the COVID-19 Public Health Emergency, the Trump Administration has issued an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. These temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. The goals of these actions are to 1) expand the healthcare system workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the community or from other states; 2) ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients; this includes temporary expansion sites (also known as CMS Hospital Without Walls); 3) increase access to telehealth in Medicare to ensure patients have access to physicians and other clinicians while keeping patients safe at home; 4) expand in-place testing to allow for more testing at home or in community based settings and establish data reporting vehicles that are critical to addressing the pandemic; and 5) put Patients Over Paperwork to give temporary relief from many paperwork, reporting and audit requirements so providers, health care facilities, Medicare Advantage and Part D plans, and States can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.

Patients Over Paperwork

• • Physical Environment: Provided that the State has approved the location as one that sufficiently addresses safety and comfort for patients and staff, CMS is waiving requirements under 42 CFR §483.90 to allow for a non-SNF/NF building to be temporarily certified as and available for use by a SNF in the event there are needs for isolation processes for COVID-19 positive residents which may not be feasible in the existing SNF structure to ensure care and services during treatment for COVID-19 is available while protecting other vulnerable adults. CMS believes this will also provide another measure that will free up inpatient care beds at hospitals for the most acute patients while providing beds for those still in need of care. CMS will waive certain conditions of participation and certification requirements for opening a SNF/NF if the state determines there is a need to quickly stand up a temporary COVID-19 isolation and treatment location. To assist with isolation needs, CMS is also temporarily allowing for rooms in a long-term care facility not normally used as a resident’s room, to be used to accommodate beds and residents for resident care in emergencies and situations needed to help with surge capacity. Rooms that may be used for this purpose include activity rooms, meeting/conference rooms, dining rooms, or other rooms, as long as residents can be kept safe, comfortable, and other applicable requirements for participation are met. This can be done so long as it is not inconsistent with a state’s emergency preparedness or pandemic plan, or as directed by the local or state health department.

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• • 3- Day Prior Hospitalization: Using the waiver authority under Section 1812(f) of the Social Security Act, CMS is temporarily waiving the requirement for a 3-day prior hospitalization for coverage of a skilled nursing facility (SNF) stay. This waiver provides temporary emergency coverage of SNF services without a qualifying hospital stay. In addition, for certain beneficiaries who exhausted their SNF benefits, it authorizes renewed SNF coverage without first having to start and complete a 60-day “wellness period” (that is, the 60-day period of non-inpatient status that is normally required in order to end the current benefit period and renew SNF benefits). This waiver will apply only for those beneficiaries who have been delayed or prevented by the emergency itself from commencing or completing the 60-day “wellness period” that would have occurred under normal circumstances. By contrast, if the patient has a continued skilled care need (such as a feeding tube) that is unrelated to the COVID-19 emergency, then the beneficiary cannot renew his or her SNF benefits under the Section 1812(f) waiver, as it is this continued skilled care in the SNF rather than the emergency that is preventing the beneficiary from beginning the 60-day “wellness period.”
• • Reporting Minimum Data Set: CMS is waiving 42 CFR §483.20 to provide relief to SNFs on the timeframe requirements for Minimum Data Set assessments and transmission.

• • Staffing Data Submission: CMS is waiving 42 CFR 483.70(q) to provide relief to long term care facilities on the requirements for submitting staffing data through the Payroll-Based Journal system.

• • Waive Pre-Admission Screening and Annual Resident Review (PASRR): CMS is allowing states and nursing homes to suspend these assessments for new residents for 30 days. After 30 days, new patients admitted to nursing homes with a mental illness (MI) or intellectual disability (ID) should receive the assessment as soon as resources become available.

• • Resident Groups: CMS is waiving the requirements at §483.10(f)(5) to allow for residents to have the right to participate in-person in resident groups. This waiver would only permit the facility to restrict having in-person meetings during the national emergency given the recommendations of social distancing and limiting gatherings of more than ten people. Refraining from in-person gatherings will help prevent the spread of COVID-19.

• • Quality Assurance and Performance Improvement (QAPI). CMS is modifying certain requirements in 42 CFR §483.75, which requires long-term care facilities to develop, implement, evaluate, and maintain an effective, comprehensive, data-driven QAPI program. Specifically, CMS is modifying §483.75(b)–(d) and (e)(3) to the extent necessary to narrow the scope of the QAPI program to focus on adverse events and infection control. This will help ensure facilities focus on aspects of care delivery most closely associated with COVID-19 during the PHE.

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• • In-Service Training: CMS is modifying the nurse aide training requirements at §483.95(g)(1) for SNFs and NFs, which requires the nursing assistant to receive at least 12 hours of in-service training annually. In accordance with section 1135(b)(5) of the Act, we are postponing the deadline for completing this requirement throughout the COVID-19 PHE until the end of the first full quarter after the declaration of the PHE concludes.
• • Detailed Information Sharing for Discharge Planning for Long-Term Care (LTC) Facilities. CMS is waiving the discharge planning requirement in §483.21(c)(1)(viii), which requires LTC facilities to assist residents and their representatives in selecting a post-acute care provider using data, such as standardized patient assessment data, quality measures and resource use. This temporary waiver is to provide facilities the ability to expedite discharge and movement of residents among care settings. CMS is maintaining all other discharge planning requirements, such as but not limited to, ensuring that the discharge needs of each resident are identified and result in the development of a discharge plan for each resident; and involving the interdisciplinary team, as defined at 42 CFR §483.21(b)(2)(ii), in the ongoing process of developing the discharge plan address the resident’s goals of care and treatment preferences.
• • Clinical Records. Pursuant to section 1135(b)(5) of the Act, CMS is modifying the requirement at 42 CFR §483.10(g)(2)(ii) which requires long-term care (LTC) facilities to provide a resident a copy of their records within two working days (when requested by the resident). Specifically, CMS is modifying the timeframe requirements to allow LTC facilities ten working days to provide a resident’s record rather than two working days.

• • Provider Enrollment: CMS has established toll-free hotlines for all providers and Part A certified providers and suppliers establishing isolation facilities to enroll and receive temporary Medicare billing privileges. In addition, the following flexibilities are provided for provider enrollment:

• o Waive certain screening requirements.
• o Postpone all revalidation actions.
• o Expedite any pending or new applications from providers.

Establish data reporting vehicle critical to addressing the pandemic

• • Required Facility Reporting: Under the new §483.80(g), CMS is requiring facilities to report COVID-19 cases in their facility to the CDC National Health Safety Network (NHSN) on a weekly basis. CDC and CMS will use information collected through the new NHSN Long-term Care COVID-19 Module to strengthen COVID-19 surveillance locally and nationally; monitor trends in infection rates; and help local, state, and federal health authorities get help to nursing homes faster. Nursing home reporting to the CDC is a critical component of the national COVID-19 surveillance system and to efforts to

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• reopen America. The information will also be posted online for the public to be aware of how the COVID-19 pandemic is affecting nursing homes.

Facilities are also required to notify residents, their representatives, and families of residents in facilities of the status of COVID-19 in the facility, which includes any new cases of COVID-19 as they are identified. This action supports CMS’ commitment to transparency so that individuals know important information about their environment, or the environment of a loved one.

Payment

• • Accelerated/Advance Payments: In order to provide additional cash flow to healthcare providers and suppliers impacted by COVID-19, CMS expanded and streamlined the Accelerated and Advance Payments Program, which provided conditional partial payments to providers and suppliers to address disruptions in claims submission and/or claims processing subject to applicable safeguards for fraud, waste and abuse. Under this program, CMS made successful payment of over $100 billion to healthcare providers and suppliers. As of April 26, 2020, CMS is reevaluating all pending and new applications for the Accelerated Payment Program and has suspended the Advance Payment Program, in light of direct payments made available through the Department of Health & Human Services’ (HHS) Provider Relief Fund. Distributions made through the Provider Relief Fund do not need to be repaid. For providers and suppliers who have received accelerated or advance payments related to the COVID-19 Public Health Emergency, CMS will not pursue recovery of these payments until 120 days after the date of payment issuance. Providers and suppliers with questions regarding the repayment of their accelerated or advance payment(s) should contact their appropriate Medicare Administrative Contractor (MAC).

Medicare appeals in Fee for Service, Medicare Advantage (MA) and Part D

• • CMS is allowing Medicare Administrative Contractors (MACs) and Qualified Independent Contractor (QICs) in the FFS program 42 CFR 405.942 and 42 CFR 405.962 and MA and Part D plans, as well as the Part C and Part D Independent Review Entity (IREs), 42 CFR 562, 42 CFR 423.562, 42 CFR 422.582 and 42 CFR 423.582 to allow extensions to file an appeal;

• • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and the Part C and Part D IREs to waive requirements for timeliness for requests for additional information to adjudicate appeals; MA plans may extend the timeframe to adjudicate organization determinations and reconsiderations for medical items and services (but not Part B drugs) by up to 14 calendar days if: the enrollee requests the extension; the extension is justified and in the enrollee’s interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization’s decision to deny an item or service; or, the extension is justified due to

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• extraordinary, exigent, or other non-routine circumstances and is in the enrollee’s interest 42 CFR § 422.568(b)(1)(i), § 422.572(b)(1) and § 422.590(f)(1);

• • CMS is allowing MACs and QICs in the FFS program 42 C.F.R 405.910 and MA and Part D plans, as well as the Part C and Part D IREs to process an appeal even with incomplete Appointment of Representation forms 42 CFR § 422.561, 42 CFR § 423.560. However, any communications will only be sent to the beneficiary;

• • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs to process requests for appeal that don’t meet the required elements using information that is available 42 CFR § 422.562, 42 CFR § 423.562.

• • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs, 42 CFR 422.562, 42 CFR 423.562 to utilize all flexibilities available in the appeal process as if good cause requirements are satisfied.

Cost Reporting

• • CMS is delaying the filing deadline of certain cost report due dates due to the COVID-19 outbreak; 42 CFR § 413.24(f)(2)(ii) allows this flexibility. CMS will delay the filing deadline of FYE 10/31/2019 cost reports due by March 31, 2020 and FYE 11/30/2019 cost reports due by April 30, 2020. The extended cost report due dates for these October and November FYEs will be June 30, 2020. CMS will also delay the filing deadline of the FYE 12/31/2019 cost reports due by May 31, 2020. The extended cost report due date for FYE 12/31/2019 will be July 31, 2020.

CMS Facility without Walls (Temporary Expansion Sites)

• • Transfers of COVID -19 Patients: A long term care (LTC) facility can temporarily transfer its COVID-19 positive resident(s) to another facility, such as a COVID-19 isolation and treatment location, with the provision of services “under arrangements.” The transferring LTC facility need not issue a formal discharge in this situation, as it is still considered the provider and should bill Medicare normally for each day of care. The transferring LTC facility is then responsible for reimbursing the other provider that accepted its resident(s) during the emergency period. This is consistent with recent CDC guidance, and helps residents with COVID-19 by placing them into facilities that are prepared to care for them. It also helps residents without COVID-19 by placing them in facilities without other COVID-19 residents, thus helping to protect them from being infected.

If the LTC facility does not intend to provide services under arrangement, the COVID-19 isolation and treatment facility is the responsible entity for Medicare billing purposes. The SNF should follow the procedures described in 40.3.4 of the Medicare Claims 4/29/202020 6

Processing Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c06.pdf) to submit a discharge bill to Medicare. The COVID-19 isolation and treatment facility should then bill Medicare appropriately for the type of care it is providing for the beneficiary. If the COVID-19 isolation and treatment facility is not yet an enrolled provider, the facility should enroll through the provider enrollment hotline for the Medicare Administrative Contractor that services their geographic area to establish temporary Medicare billing privileges.

• • Resident Transfer and Discharge: CMS is waiving requirements in 42 CFR 483.10(c)(5); 483.15(c)(3), (c)(4)(ii), (c)(5)(i) and (iv), (c)(9), and (d); and § 483.21(a)(1)(i), (a)(2)(i), and (b) (2)(i) (with some exceptions noted below) to allow a long term care facility to transfer or discharge residents to another LTC facility solely for the following cohorting purposes:

1. Transferring residents with symptoms of a respiratory infection or confirmed diagnosis of COVID-19 to another facility that agrees to accept each specific resident, and is dedicated to the care of such residents;

2. Transferring residents without symptoms of a respiratory infection or confirmed to not have COVID-19 to another facility that agrees to accept each specific resident, and is dedicated to the care of such residents to prevent them from acquiring COVID-19, as well as providing treatment or therapy for other conditions as required by the resident’s plan of care; or

• o These requirements are only waived in cases where the transferring facility receives confirmation that the receiving facility agrees to accept the resident to be transferred or discharged. Confirmation may be in writing or verbal. If verbal, the transferring facility needs to document the date, time, and person that the receiving facility communicated agreement.
  • In § 483.10, we are only waiving the requirement, under § 483.10(c)(5), that a facility provide advance notification of options relating to the transfer or discharge to another facility. Otherwise, all requirements related to § 483.10 continue to apply. Similarly, in § 483.15, we are only waiving the requirement, under § 483.15(c)(3), (c)(4)(ii), (c)(5)(i) and (iv), and (d), for the written notice of transfer or discharge to be provided before the transfer or discharge. This notice must be provided as soon as practicable.

Exceptions: 4/29/202020 7

• o In § 483.21, we are only waiving the timeframes for certain care planning requirements for residents who are transferred or discharged for the purposes explained in 1–3 above. Receiving facilities should complete the required care plans as soon as practicable, and we expect receiving facilities to review and use the care plans for residents from the transferring facility, and adjust as necessary to protect the health and safety of the residents they apply to.
  • o These requirements are also waived when the transferring residents to another facility, such as a COVID-19 isolation and treatment location, with the provision of services “under arrangements,” as long as it is not inconsistent with a state’s emergency preparedness or pandemic plan, or as directed by the local or state health department. In these cases, the transferring LTC facility need not issue a formal discharge, as it is still considered the resident’s provider and should bill Medicare normally for each day of care. The transferring LTC facility is then responsible for reimbursing the other provider that accepted its resident(s) during the emergency period. o If the LTC facility does not intend to provide services under arrangement, the COVID-19 isolation and treatment facility is the responsible entity for Medicare billing purposes. The LTC facility should follow the procedures described in 40.3.4 of the Medicare Claims Processing Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c06.pdf) to submit a discharge bill to Medicare. The COVID-19 isolation and treatment facility should then bill Medicare appropriately for the type of care it is providing for the beneficiary. If the COVID-19 isolation and treatment facility is not yet an enrolled provider, the facility should enroll through the provider enrollment hotline for the Medicare Administrative Contractor that services their geographic area to establish temporary Medicare billing privileges.
  •  
  •  

We remind LTC facilities that they are responsible for ensuring that any transfers (either within a facility, or to another facility) are conducted in a safe and orderly manner, and that each resident’s health and safety is protected. We also remind states that under 42 CFR 488.426(a)(1), in an emergency, the State has the authority to transfer Medicaid and Medicare residents to another facility.

• • Resident Roommates and Grouping: CMS is waiving the requirements in 42 CFR 483.10(e)(5), (6), and (7) solely for the purposes of grouping or cohorting residents with respiratory illness symptoms and/or residents with a confirmed diagnosis of COVID-19, and separating them from residents who are asymptomatic or tested negative for COVID-19. This action waives a facility’s requirements, under 42 CFR 483.10, to provide for a resident to share a room with his or her roommate of choice in certain circumstances, to provide notice and rationale for changing a resident’s room, and to

4/29/202020 8

• provide for a resident’s refusal a transfer to another room in the facility. This aligns with CDC guidance to preferably place residents in locations designed to care for COVID-19 residents, to prevent the transmission of COVID-19 to other residents.
• • Inspection, Testing & Maintenance (ITM) under the Physical Environment Conditions of Participation: CMS is waiving certain physical environment requirements for Hospitals, CAHs, inpatient hospice, ICF/IIDs, and SNFs/NFs to reduce disruption of patient care and potential exposure/transmission of COVID-19. The physical environment regulations require that facilities and equipment be maintained to ensure an acceptable level of safety and quality. CMS will permit facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment.

Specific Physical Environment Waiver Information:

• o 42 CFR §482.41(d) for hospitals, §485.623(b) for CAH, §418.110(c)(2)(iv) for inpatient hospice, §483.470(j) for ICF/IID; and §483.90 for SNFs/NFs all require these facilities and their equipment to be maintained to ensure an acceptable level of safety and quality. CMS is temporarily modifying these requirements to the extent necessary to permit these facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment.
• o 42 CFR §482.41(b)(1)(i) and (c) for hospitals, §485.623(c)(1)(i) and (d) for CAHs, §482.41(d)(1)(i) and (e) for inpatient hospices, §483.470(j)(1)(i) and (5)(v) for ICF/IIDs, and §483.90(a)(1)(i) and (b) for SNFs/NFs require these facilities to be in compliance with the Life Safety Code (LSC) and Health Care Facilities Code (HCFC). CMS is temporarily modifying these provisions to the extent necessary to permit these facilities to adjust scheduled ITM frequencies and activities required by the LSC and HCFC. The following LSC and HCFC ITM are considered critical are not included in this waiver:
• • Sprinkler system monthly electric motor-driven and weekly diesel engine-driven fire pump testing.
• • Portable fire extinguisher monthly inspection.
• • Elevators with firefighters’ emergency operations monthly testing.
• • Emergency generator 30 continuous minute monthly testing and associated transfer switch monthly testing.
• • Means of egress daily inspection in areas that have undergone construction, repair, alterations or additions to ensure its ability to be used instantly in case of emergency.
• o 42 CFR §482.41(b)(9) for hospitals, §485.623(c)(7) for CAHs, §418.110(d)(6) for inpatient hospices, §483.470(e)(1)(i) for ICF/IIDs, and §483.90(a)(7) for SNFs/NFs require these facilities to have an outside window or outside door in every sleeping room. CMS will permit a waiver of these outside window and outside door

4/29/202020 9

• requirements to permit these providers to utilize facility and non-facility space that is not normally used for patient care to be utilized for temporary patient care or quarantine.

Workforce

• o Physician Delegation of Tasks in SNFs: 42 CFR 483.30(e)(4). CMS is waiving the requirement in § 483.30(e)(4) that prevents a physician from delegating a task when the regulations specify that the physician must perform it personally. This waiver gives physicians the ability to delegate any tasks to a physician assistant, nurse practitioner, or clinical nurse specialist who meets the applicable definition in 42 CFR 491.2 or, in the case of a clinical nurse specialist, is licensed as such by the State and is acting within the scope of practice laws as defined by State law. We are temporarily modifying this regulation to specify that any task delegated under this waiver must continue to be under the supervision of the physician. This waiver does not include the provision of § 483.30(e)(4) that prohibits a physician from delegating a task when the delegation is prohibited under State law or by the facility’s own policy.
  • Physician Visits: 42 CFR 483.30(c)(3). CMS is waiving the requirement at § 483.30(c)(3) that all required physician visits (not already exempted in § 483.30(c)(4) and (f)) must be made by the physician personally. We are modifying this provision to permit physicians to delegate any required physician visit to a nurse practitioner (NPs), physician assistant, or clinical nurse specialist who is not an employee of the facility, who is working in collaboration with a physician, and who is licensed by the State and performing within the state’s scope of practice laws.
  • Note to Facilities: These actions will assist in potential staffing shortages, maximize the use of medical personnel, and protect the health and safety of residents during the PHE. We note that we are not waiving the requirements for the frequency of required physician visits at § 483.30(c)(1). As set out above, we have only modified the requirement to allow for the requirement to be met by an NP, physician assistant, or clinical nurse specialist, and via telehealth or other remote communication options, as appropriate. In addition, we note that we are not waiving our requirements for physician supervision in § 483.30(a)(1), and the requirement at § 483.30(d)(3) for the facility to provide or arrange for the provision of physician services 24 hours a day, in case of an emergency. It is important that the physician be available for consultation regarding a resident’s care.

• • Training and Certification of Nurse Aides: CMS is waiving the requirements at 42 CFR §483.35(d), (except for 42 CFR §483.35(d)(1)(i)), which require that a SNF and NF may

4/29/202020 10

• not employ anyone for longer than four months unless they met the training and certification requirements under §483.35(d). CMS is waiving these requirements to assist in potential staffing shortages seen with the COVID-19 pandemic. To ensure the health and safety of nursing home residents, CMS is not waiving §483.35(d)(1)(i), which requires facilities to not use any individual working as a nurse aide for more than four months, on a full-time basis, unless that individual is competent to provide nursing and nursing related services. We further note that we are not waiving §483.35(c), which requires facilities to ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents’ needs, as identified through resident assessments, and described in the plan of care. Achieving adequate staffing levels may be a concern for SNFs and NFs during the public health emergency. CMS is temporarily waiving these requirements so they do not present barriers for SNFs and NFs to hire staff; the temporary waiver will help these facilities provide adequate levels of staffing for the duration of the COVID-19 pandemic.

Medicare Telehealth

• • Physician visits in skilled nursing facilities/nursing facilities: CMS is waiving the requirement in 42 CFR 483.30 for physicians and non-physician practitioners to perform in-person visits for nursing home residents and allow visits to be conducted, as appropriate, via telehealth options.

Additional Guidance

• • The Interim Final Rule and waivers can be found at: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers .

• • CMS has released guidance to describe standards of practice for infection control and prevention of COVID-19 at https://www.cms.gov/files/document/qso-20-14-nh-revised.pdf

• • CMS has released guidance to providers related to relaxed reporting requirements for quality reporting programs at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf

The post CMS Flexibilities to Fight COVID-19 – Long Term Care Facilities (Skilled Nursing Facilities and/or Nursing Facilities) appeared first on mTelehealth.

Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs): CMS Flexibilities to Fight COVID-19

Since the beginning of the COVID-19 Public Health Emergency, the Trump Administration has issued an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. These temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. The goals of these actions are to 1) expand the healthcare system workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the community or from other states; 2) ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites (also known as CMS Hospital Without Walls); 3) increase access to telehealth in Medicare to ensure patients have access to physicians and other clinicians while keeping patients safe at home; 4) expand in-place testing to allow for more testing at home or in community based settings; and 5) put Patients Over Paperwork to give temporary relief from many paperwork, reporting and audit requirements so providers, health care facilities, Medicare Advantage and Part D plans, and States can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.

Medicare Telehealth

• https://www.cms.gov/Medicare/Medicare-General-Information/ Telehealth/Telehealth-Codes.

Workforce

2

• • CMS is waiving the requirement in the second sentence of 42 CFR §491.8(a)(6) that a nurse practitioner, physician assistant, or certified nurse-midwife be available to furnish patient care services at least 50 percent of the time the RHC and FQHC operates. CMS is not waiving the first sentence of §491.8(a)(6) that requires a physician, nurse practitioner, physician assistant, certified nurse-midwife, clinical social worker, or clinical psychologist to be available to furnish patient care services at all times the clinic or center operates. This will assist in addressing potential staffing shortages by increasing flexibility regarding staffing mixes during the PHE.
  • We are modifying the requirement at 42 C.F.R. 491.8(b)(1) that physicians must provide medical direction for the clinic’s or center’s health care activities and consultation for, and medical supervision of, the health care staff, only with respect to medical supervision of nurse practitioners, and only to the extent permitted by state law. The physician, either in person or through telehealth and other remote communications, continues to be responsible for providing medical direction for the clinic or center’s health care activities and consultation for the health care staff, and medical supervision of the remaining health care staff. This allows RHCs and FQHCs to use nurse practitioners to the fullest extent possible and allows physicians to direct their time to more critical tasks.

Patients Over Paperwork

• • The physician self-referral law (also known as the “Stark Law”) prohibits a physician from making referrals for certain healthcare services payable by Medicare if the physician (or an immediate family member) has a financial relationship with the entity performing the service. There are statutory and regulatory exceptions, but in short, a physician cannot refer a patient to any entity with which he or she has a financial relationship. On March 30, 2020, CMS issued blanket waivers of certain provisions of the Stark Law regulations. These blanket waivers apply to financial relationships and referrals that are related to the COVID-19 emergency. The remuneration and referrals described in the blanket waivers must be solely related to COVID-19 Purposes, as defined in the blanket waiver document. Under the waivers, CMS will permit certain referrals and the submission of related claims that would otherwise violate the Stark Law. These flexibilities include: Hospitals and other health care providers can pay above or below fair market value for the personal services of a physician (or an immediate family member of a physician), and parties may pay below fair market value to rent equipment or purchase items or services. For example, a physician practice may be willing to rent or sell needed equipment to a hospital at a price that is below what the practice could charge another party. Or, a hospital may provide space on hospital grounds at no charge to a physician who is willing to treat patients who seek care at the hospital but are not appropriate for emergency department or inpatient care.

3

• • CCMS has established toll-free hotlines for all providers as well as the following flexibilities for provider enrollment: Waive certain screening requirements.

Payment

4

1. In order to provide additional cash flow to healthcare providers and suppliers impacted by COVID-19, CMS expanded and streamlined the Accelerated and Advance Payments Program, which provided conditional partial payments to providers and suppliers to address disruptions in claims submission and/or claims processing subject to applicable safeguards for fraud, waste and abuse. Under this program, CMS made successful payment of over $100 billion to healthcare providers and suppliers. As of April 26, 2020, CMS is reevaluating all pending and new applications for the Accelerated Payment Program and has suspended the Advance Payment Program, in light of direct payments made available through the Department of Health & Human Services’ (HHS) Provider Relief Fund. Distributions made through the Provider Relief Fund do not need to be repaid. For providers and suppliers who have received accelerated or advance payments related to the COVID-19 Public Health Emergency, CMS will not pursue recovery of these payments until 120 days after the date of payment issuance. Providers and suppliers with questions regarding the repayment of their accelerated or advance payment(s) should contact their appropriate Medicare Administrative Contractor (MAC).

Medicare appeals in Fee for Service, Medicare Advantage (MA) and Part D

5

Cost Reporting

Additional Guidance

• https://www.cms.gov/about-cms/ emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.
• https://www.cms.gov/medicareprovider-enrollment-and-certi ficationsurveycertificationgeninfopolicy-and-memos-states-and/guidance-infection-control-and-prevention-coronavirus-disease-covid-19-outpatient-settings-faqs.

The post CMS Flexibilities to Fight COVID-19 – Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) appeared first on mTelehealth.

Long Term Care Hospitals & Extended Neoplastic Disease Care Hospitals: CMS Flexibilities to Fight COVID-19

04/29/20202

Since the beginning of the COVID-19 Public Health Emergency, the Trump Administration has issued an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. These temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. The goals of these actions are to 1) expand the healthcare system workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the community or from other states; 2) ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites (also known as CMS Hospital Without Walls); 3) increase access to telehealth in Medicare to ensure patients have access to physicians and other clinicians while keeping patients safe at home; 4) expand in-place testing to allow for more testing at home or in community based settings; and 5) put Patients Over Paperwork to give temporary relief from many paperwork, reporting and audit requirements so providers, health care facilities, Medicare Advantage and Part D plans, and States can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.

• As required by section 3711(b) of the CARES Act, during the Public Health Emergency (PHE) due to COVID-19, certain provisions of section 1886(m)(6) of the Social Security Act have been waived relating to certain site neutral payment rate provisions for long-term care hospitals (LTCHs). Section 3711(b)(1) of the CARES Act waives the payment adjustment under section 1886(m)(6)(C)(ii) of the Act for LTCHs that do not have a discharge payment percentage (DPP) for the period that is at least 50 percent during the COVID-19 public health emergency period. Under this provision, for the purposes of calculating an LTCH’s DPP, all admissions during the COVID-19 public health emergency period will be counted in the numerator of the calculation. In other words, LTCH cases that were admitted during the COVID-19 public health emergency period will be counted as discharges paid the LTCH PPS standard Federal payment rate.

11 04/29/20202 21

Patients Over Paperwork

• Patient Stay Requirements: CMS will count patient stays where an LTCH admits or discharges patients in order to meet the demands of the emergency as compliant with the 25-day average length of stay requirement, which allows these facilities to be paid as LTCHs. In addition, during the applicable waiver time period, we would also apply this policy to facilities not yet classified as LTCHs, but seeking classification as an LTCH.
  • The physician self-referral law (also known as the “Stark Law”) prohibits a physician from making referrals for certain healthcare services payable by Medicare if the physician (or an immediate family member) has a financial relationship with the entity performing the service. There are statutory and regulatory exceptions, but in short, a physician cannot refer a patient to any entity with which he or she has a financial relationship. On March 30, 2020, CMS issued blanket waivers of certain provisions of the Stark Law regulations. These blanket waivers apply to financial relationships and referrals that are related to the COVID-19 emergency. The remuneration and referrals described in the blanket waivers must be solely related to COVID-19 Purposes, as defined in the blanket waiver document. Under the waivers, CMS will permit certain referrals and the submission of related claims that would otherwise violate the Stark Law. These flexibilities include: Hospitals and other health care providers can pay above or below fair market value for the personal services of a physician (or an immediate family member of a physician), and parties may pay below fair market value to rent equipment or purchase items or services. For example, a physician practice may be willing to rent or sell needed equipment to a hospital at a price that is below what the practice could charge another party. Or, a hospital may provide space on hospital grounds at no charge to a physician who is willing to treat patients who seek care at the hospital but are not appropriate for emergency department or inpatient care.

04/29/20202 31

04/29/20202 41

• CMS has established toll-free hotlines for all providers as well as the following flexibilities for provider enrollment: Waive certain screening requirements.

Medicare Appeals in Fee-for-Service, Medicare Advantage (MA) and Part D

• CMS is allowing Medicare Administrative Contractors (MACs) and Qualified Independent Contractor (QICs) in the FFS program 42 CFR 405.942 and 42 CFR 405.962 and MA and Part D plans, as well as the Part C and Part D Independent Review Entity (IREs), 42 CFR 562, 42 CFR 423.562, 42 CFR 422.582 and 42 CFR 423.582 to allow extensions to file an appeal;
•  
• CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and the Part C and Part D IREs to waive requirements for timeliness for requests for additional information to adjudicate appeals; MA plans may extend the timeframe to adjudicate organization determinations and reconsiderations for medical items and services (but not Part B drugs) by up to 14 calendar days if: the enrollee requests the extension; the extension is justified and in the enrollee’s interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization’s decision to deny an item or service; or, the extension is justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee’s interest 42 CFR § 422.568(b)(1)(i), § 422.572(b)(1) and § 422.590(f)(1);
• CMS is allowing MACs and QICs in the FFS program 42 C.F.R 405.910 and MA and Part D plans, as well as the Part C and Part D IREs to process an appeal even with incomplete Appointment of Representation forms 42 CFR § 422.561, 42 CFR § 423.560. However, any communications will only be sent to the beneficiary;
  • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs to process requests for appeal that don’t meet the required elements using information that is available 42 CFR § 422.562, 42 CFR §
  •  
  • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs, 42 CFR 422.562, 42 CFR 423.562 to utilize all flexibilities available in the appeal process as if good cause requirements are satisfied.

Cost Reporting

1. CMS is delaying the filing deadline of certain cost report due dates due to the COVID-19 outbreak. We are currently authorizing delay for the following fiscal year end (FYE) dates. CMS will delay the filing deadline of FYE 10/31/2019 cost reports due by March 31, 2020 and FYE 11/30/2019 cost reports due by April 30, 2020. The extended cost report due dates for these October and November FYEs will be June 30, 2020. CMS will also delay the filing deadline of the FYE 12/31/2019 cost reports due by May 31, 2020. The extended cost report due date for FYE 12/31/2019 will be July 31, 2020.

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Additional Guidance

1. The Interim Final Rules and waivers can be found at: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.
2. CMS has released guidance to providers related to relaxed reporting requirements for quality reporting programs at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.

The post CMS Flexibilities to Fight COVID-19 – Long Term Care Hospitals & Extended Neoplastic Disease Care Hospitals appeared first on mTelehealth.

4/29/2020

Inpatient Rehabilitation Facilities: CMS Flexibilities to Fight COVID-19

Since the beginning of the COVID-19 Public Health Emergency, the Trump Administration has issued an

unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare

system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. These

temporary changes will apply immediately across the entire U.S. healthcare system for the duration of

the emergency declaration. The goals of these actions are to 1) expand the healthcare system workforce

by removing barriers for physicians, nurses, and other clinicians to be readily hired from the community

or from other states; 2) ensure that local hospitals and health systems have the capacity to handle a

potential surge of COVID-19 patients through temporary expansion sites (also known as CMS Hospital

Without Walls); 3) increase access to telehealth in Medicare to ensure patients have access to physicians

and other clinicians while keeping patients safe at home; 4) expand in-place testing to allow for more

testing at home or in community based settings; and 5) put Patients Over Paperwork to give temporary

relief from many paperwork, reporting and audit requirements so providers, health care facilities,

Medicare Advantage and Part D plans, and States can focus on providing needed care to Medicare and

Medicaid beneficiaries affected by COVID-19.

Medicare Telehealth

• Telehealth may be used to fulfill the requirement for physicians to conduct the required face-toface

visits at least 3 days a week for the duration of a Medicare Part A fee-for-service patient’s stay

in an inpatient rehabilitation facility.

Patients Over Paperwork

• “Stark Law” Waivers: The physician self-referral law (also known as the “Stark Law”) prohibits

a physician from making referrals for certain healthcare services payable by Medicare if the

physician (or an immediate family member) has a financial relationship with the entity performing

the service. There are statutory and regulatory exceptions, but in short, a physician cannot refer

a patient to any entity with which he or she has a financial relationship. On March 30, 2020, CMS

issued blanket waivers of certain provisions of the Stark Law regulations. These blanket waivers

apply to financial relationships and referrals that are related to the COVID-19 emergency. The

remuneration and referrals described in the blanket waivers must be solely related to COVID-19

Purposes, as defined in the blanket waiver document. Under the waivers, CMS will permit certain

referrals and the submission of related claims that would otherwise violate the Stark Law. These

flexibilities include:

o Hospitals and other health care providers can pay above or below fair market value for

the personal services of a physician (or an immediate family member of a physician), and

parties may pay below fair market value to rent equipment or purchase items or services.

For example, a physician practice may be willing to rent or sell needed equipment to a

hospital at a price that is below what the practice could charge another party. Or, a hospital

may provide space on hospital grounds at no charge to a physician who is willing to treat

patients who seek care at the hospital but are not appropriate for emergency department or

inpatient care.

o Health care providers can support each other financially to ensure continuity of health care

operations. For example, a physician owner of a hospital may make a personal loan to the

hospital without charging interest at a fair market rate so that the hospital can make payroll

or pay its vendors.

4/29/2020

2

o Hospitals can provide benefits to their medical staffs, such as multiple daily meals, laundry

service to launder soiled personal clothing, or child care services while the physicians are at

the hospital and engaging in activities that benefit the hospital and its patients.

o Health care providers may offer certain items and services that are solely related to

COVID-19 Purposes (as defined in the waivers), even when the provision of the items or

services would exceed the annual non-monetary compensation cap. For example, a home

health agency may provide continuing medical education to physicians in the community

on the latest care protocols for homebound patients with COVID-19, or a hospital may

provide isolation shelter or meals to the family of a physician who was exposed to the novel

coronavirus while working in the hospital’s emergency department.

o Physician-owned hospitals can temporarily increase the number of their licensed beds,

operating rooms, and procedure rooms, even though such expansion would otherwise be

prohibited under the Stark Law. For example, a physician-owned hospital may temporarily

convert observation beds to inpatient beds to accommodate patient surge during the

COVID-19 pandemic in the United States.

o Some of the restrictions regarding when a group practice can furnish medically necessary

designated health services (DHS) in a patient’s home are loosened. For example, any

physician in the group may order medically necessary DHS that is furnished to a patient by

one of the group’s technicians or nurses in the patient’s home contemporaneously with a

physician service that is furnished via telehealth by the physician who ordered the DHS.

o Group practices can furnish medically necessary MRIs, CT scans or clinical laboratory services

from locations like mobile vans in parking lots that the group practice rents on a part-time

basis.

• Intensity of Therapy Requirement (“3-Hour Rule”): The Coronavirus Aid, Relief, and

Economic Security (CARES) Act requires the Secretary to waive § 412.622(a)(3)(ii)

(commonly referred to as the “3-hour rule”), the criterion that patients treated in inpatient

rehabilitation facilities generally receive at least 15 hours of therapy per week. The waiver

of this requirement for all beneficiaries treated in a hospital-based or freestanding IRF

provides flexibility for IRFs to provide care for patients during the PHE for the COVID-19

pandemic. IRFs should strive to provide typical IRF levels of care for beneficiaries admitted

during the COVID-19 crisis who require and can benefit from the IRF levels of care.

• Standards to Rehabilitate Patients: Medicare payment regulations require IRFs to meet certain

standards to rehabilitate patients, including ensuring that admitted patients are stable enough

for rehabilitation therapy, need at least two types of therapy, and develop plans of care. During

the PHE, these standards do not have to apply to patients who are admitted to freestanding IRFs

solely for surge capacity reasons in a state that is currently in Phase 1 or has not yet entered Phase

1 of the White House’s Guidelines for Opening Up America Again, but would continue to apply

to patients who are admitted for the IRFs’ standard rehabilitative services. We anticipate that

freestanding IRFs will take advantage of these flexibilities for some of their beneficiaries (those

who are surge patients from inpatient hospitals), while continuing to provide standard IRF-level

care for those beneficiaries who would benefit from IRF-level care and would otherwise receive

such care in the absence of the PHE.

• IRF Teaching Status Adjustment Payments: To ensure that teaching IRFs can alleviate bed capacity

issues by taking patients from the inpatient acute care hospitals without being penalized by lower

teaching status adjustments, we are freezing the IRFs’ teaching status adjustment payments at

4/29/2020

3

their values prior to the PHE. For the duration of the COVID-19 PHE, an IRF’s teaching status

adjustment payments will be the same as they were on the day before the COVID-19 PHE was

declared.

• IRF Quality Reporting Program: We are delaying the compliance dates for collecting and

reporting of the Transfer of Health Information quality measures and certain standardized patient

assessment data elements (SPADEs) adopted for the IRF Quality Reporting Program. IRFs will

be required to begin collecting the Transfer of Health Information quality measures and certain

SPADEs on October 1st of the year that is at least one fiscal year after the end of the public health

emergency.

• Post Admission Evaluations: Physicians are no longer required to conduct and document postadmission

evaluations for Medicare patients admitted to an IRF during the PHE. The postadmission

evaluation covers much of the same information as continues to be included in the preadmission

screening of the patient and the patient’s plan of care. This reduction in burden gives

more time for physicians to take care of patients.

• Flexibility for Inpatient Rehabilitation Facilities Regarding the “60 Percent Rule”: CMS is waiving

requirements to allow IRFs to exclude patients from the IRF freestanding hospital’s or unit’s

inpatient population for purposes of calculating the applicable thresholds associated with the

requirements to receive payment as an IRF (commonly referred to as the “60 percent rule”) if an

IRF admits a patient solely to respond to the emergency and the patient’s medical record properly

identifies the patient as such. In addition, during the applicable waiver time period, we would

also apply the exception to facilities not yet classified as IRFs, but that are attempting to obtain

classification as an IRF.

• Freestanding IRFs are able to work with acute care hospitals under arrangements to provide surge

capacity for the community.

• Provider Enrollment: CMS has established toll-free hotlines for all providers as well as the following

flexibilities for provider enrollment:

o Waive certain screening requirements.

o Postpone all revalidation actions.

o Expedite any pending or new applications from providers.

Medicare appeals in Fee for Service, Medicare Advantage (MA) and Part D

• CMS is allowing Medicare Administrative Contractors (MACs) and Qualified Independent

Contractor (QICs) in the FFS program 42 CFR 405.942 and 42 CFR 405.962 and MA and Part D

plans, as well as the Part C and Part D Independent Review Entity (IREs), 42 CFR 562, 42 CFR

423.562, 42 CFR 422.582 and 42 CFR 423.582 to allow extensions to file an appeal;

• CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and

the Part C and Part D IREs to waive requirements for timeliness for requests for additional

information to adjudicate appeals; MA plans may extend the timeframe to adjudicate organization

determinations and reconsiderations for medical items and services (but not Part B drugs) by up

to 14 calendar days if: the enrollee requests the extension; the extension is justified and in the

enrollee’s interest due to the need for additional medical evidence from a noncontract provider

that may change an MA organization’s decision to deny an item or service; or, the extension is

justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee’s

interest 42 CFR § 422.568(b)(1)(i), § 422.572(b)(1) and § 422.590(f)(1);

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4

• CMS is allowing MACs and QICs in the FFS program 42 C.F.R 405.910 and MA and Part D plans,

as well as the Part C and Part D IREs to process an appeal even with incomplete Appointment of

Representation forms 42 CFR § 422.561, 42 CFR § 423.560. However, any communications will only

be sent to the beneficiary;

• CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and

MA and Part D plans, as well as the Part C and Part D IREs to process requests for appeal that

don’t meet the required elements using information that is available 42 CFR § 422.562, 42 CFR §

423.562.

• CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA

and Part D plans, as well as the Part C and Part D IREs, 42 CFR 422.562, 42 CFR 423.562 to utilize all

flexibilities available in the appeal process as if good cause requirements are satisfied.

Cost Reporting

• CMS is delaying the filing deadline of certain cost report due dates due to the COVID-19

outbreak. We are currently authorizing delay for the following fiscal year end (FYE) dates. CMS

will delay the filing deadline of FYE 10/31/2019 cost reports due by March 31, 2020 and FYE

11/30/2019 cost reports due by April 30, 2020. The extended cost report due dates for these

October and November FYEs will be June 30, 2020. CMS will also delay the filing deadline of the

FYE 12/31/2019 cost reports due by May 31, 2020. The extended cost report due date for FYE

12/31/2019 will be July 31, 2020.

• Accelerated/Advance Payments: In order to provide additional cash flow to healthcare providers

and suppliers impacted by COVID-19, CMS expanded and streamlined the Accelerated and

Advance Payments Program, which provided conditional partial payments to providers and

suppliers to address disruptions in claims submission and/or claims processing subject to

applicable safeguards for fraud, waste and abuse. Under this program, CMS made successful

payment of over $100 billion to healthcare providers and suppliers. As of April 26, 2020, CMS

is reevaluating all pending and new applications for the Accelerated Payment Program and has

suspended the Advance Payment Program, in light of direct payments made available through the

Department of Health & Human Services’ (HHS) Provider Relief Fund. Distributions made through

the Provider Relief Fund do not need to be repaid. For providers and suppliers who have received

accelerated or advance payments related to the COVID-19 Public Health Emergency, CMS will not

pursue recovery of these payments until 120 days after the date of payment issuance. Providers

and suppliers with questions regarding the repayment of their accelerated or advance payment(s)

should contact their appropriate Medicare Administrative Contractor (MAC).

Additional Information

• The Interim Final Rules can be found at: https://www.cms.gov/about-cms/emergencypreparedness-

response-operations/current-emergencies/coronavirus-waivers .

• CMS has released guidance to providers related to relaxed reporting requirements for quality

reporting programs at https://www.cms.gov/files/document/guidance-memo-exceptions-andextensions-

quality-reporting-and-value-based-purchasing-programs.pdf.

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End Stage Renal Disease (ESRD) Facilities: CMS Flexibilities to Fight COVID-19

04/29/2020

Since the beginning of the COVID-19 Public Health Emergency, the Trump Administration has issued an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. These temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. The goals of these actions are to 1) expand the healthcare system workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the community or from other states; 2) ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites (also known as CMS Hospital Without Walls); 3) increase access to telehealth in Medicare to ensure patients have access to physicians and other clinicians while keeping patients safe at home; 4) expand in-place testing to allow for more testing at home or in community based settings; and 5) put Patients Over Paperwork to give temporary relief from many paperwork, reporting and audit requirements so providers, health care facilities, Medicare Advantage and Part D plans, and States can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.

CMS is providing additional flexibilities under the Medicare program related to training and audits, preventive maintenance, emergency preparedness, patient assessment, care planning, home visits, home dialysis machine designation, Special Purpose Renal Dialysis Facilities (SPRDF) designation, dialysis patient care technician certification, physician credentialing, and payment and reimbursement.

Patients Over Paperwork

• CMS is waiving the requirement at §494.40(d) related to the condition on Water & Dialysate Quality, specifically that on-time periodic audits for operators of the water/dialysate equipment are waived to allow for flexibilities.
• CMS is waiving requirements at §494.60(b) and §494.60(d) to reduce non-essential people entering the facility to reduce risk of exposure to the virus. These waivers are intended to ensure that dialysis facilities are able to focus on the operations related to the Public Health Emergency.
• CMS is waiving the requirements at §494.62(d)(iv) which requires ESRD facilities to demonstrate as part of their Emergency Preparedness Training and Testing Program, that staff can demonstrate that, at a minimum, its patient care staff maintains current CPR certification. CMS is waiving the requirement for maintenance of CPR certification during the COVID-19 emergency due to the limited availability of CPR classes.

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1. To ensure that dialysis facility staff can focus on the increased care demands related to the COVID-19 pandemic, CMS is waiving certain requirements at §494.80(b) related to the frequency of assessment for patients admitted to the dialysis facility. CMS is waiving the “on-time” requirements for the initial and follow up comprehensive assessments within the specified timeframes as noted below. This waiver applies to assessments conducted by members of the interdisciplinary team, including: registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. CMS is not waiving subsections (a) or (c) of 42 CFR §494.80. We maintain expectations for conducting the assessment, ensuring the adequacy of the dialysis treatment, and assessing the patient’s needs when there is a change in condition. Specifically, CMS is waiving: §494.80(b) (1): An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.
   1. The ESRD Conditions for Coverage (CfCs) do not explicitly require that each home dialysis patient have their own designated home dialysis machine. The dialysis facility is required to follow FDA labeling and manufacturer’s directions for use to ensure appropriate operation of the dialysis machine and ancillary equipment. Dialysis machines must be properly cleaned and disinfected to minimize the risk of infection based on the requirements at 42 CFR 494.30 Condition: Infection Control if used to treat multiple patients.
   1. In order to provide additional cash flow to healthcare providers and suppliers impacted by COVID-19, CMS expanded and streamlined the Accelerated and Advance Payments Program, which provided conditional partial payments to providers and suppliers to address disruptions in claims submission and/or claims processing subject to applicable safeguards for fraud, waste and abuse. Under this program, CMS made successful payment of over $100 billion to healthcare providers and suppliers. As of April 26, 2020, CMS is reevaluating all pending and new applications for the Accelerated Payment Program and has suspended the Advance Payment Program, in light of direct payments made available through the Department of Health & Human Services’ (HHS) Provider Relief Fund. Distributions made through the Provider Relief Fund do not need to be repaid. For providers and suppliers who have received accelerated or advance payments related to the COVID-19 Public Health Emergency, CMS will not pursue recovery of these payments until 120 days after the date of payment issuance. Providers and suppliers with questions regarding the repayment of their accelerated or advance payment(s) should contact their appropriate Medicare Administrative Contractor (MAC).

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• CMS has established toll-free hotlines for all providers and Part A certified providers and suppliers establishing isolation facilities to enroll and receive temporary Medicare billing privileges. In addition, the following flexibilities are provided for provider enrollment: Waive certain screening requirements.

Medicare appeals in Fee for Service, Medicare Advantage (MA) and Part D

• • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs to process requests for appeal that don’t meet the required elements using information that is available 42 CFR § 422.562, 42 CFR §
    •  
    • CMS is allowing MACs and QICs in the FFS program 42 CFR 405. 950 and 42 CFR 405.966 and MA and Part D plans, as well as the Part C and Part D IREs, 42 CFR 422.562, 42 CFR 423.562 to utilize all flexibilities available in the appeal process as if good cause requirements are satisfied.

Cost Reporting

• CMS is delaying the filing deadline of certain cost report due dates due to the COVID-19 outbreak. We are currently authorizing delay for the following fiscal year end (FYE) dates. CMS will delay the filing deadline of FYE 10/31/2019 cost reports due by March 31, 2020 and FYE 11/30/2019 cost reports due by April 30, 2020. The extended cost report due dates for these
• October and November FYEs will be June 30, 2020. CMS will also delay the filing deadline of the
• FYE 12/31/2019 cost reports due by May 31, 2020. The extended cost report due date for FYE
• 12/31/2019 will be July 31, 2020.
•  

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Medicare Telehealth for ESRD

• CMS is modifying two requirements related to care planning, specifically: §494.90(b)(2): CMS is modifying the requirement which requires the dialysis facility to implement the initial plan of care within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This modification will also apply to the requirement for monthly or annual updates of the plan of care within 15 days of the completion of the additional patient assessments. CMS is waiving the time requirement for plan of care implementation during the time period of the national emergency.
  • CMS is modifying the requirement which requires the ESRD dialysis facility to ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist, or physician’s assistant providing ESRD care at least monthly, and periodically while the hemodialysis patient is receiving in-facility dialysis. CMS is waiving the requirement for a monthly in-person visit if the patient is considered stable and also recommend exercising telehealth flexibilities, e.g. phone calls, to ensure patient safety.
  • CMS is waiving the requirement at 494.100(c)(1)(i) which requires the periodic monitoring of the patient’s home adaptation, including visits to the patient’s home by facility personnel. For more information on existing flexibilities for in-center dialysis patients to receive their dialysis treatments in the home, or long-term care facility, reference QSO-20-19-ESRD.

CMS Facility without Walls (Temporary Expansion Sites)

• Special Purpose Renal Dialysis Facilities (SPRDF) designation expanded: CMS authorizes the establishment of SPRDFs to address access to care issues due to COVID-19 and the need to mitigate transmission among this vulnerable population. This will not include the normal determination regarding lack of access to care as this standard has been met during the period of the national emergency. Approval as Special Purpose Renal Dialysis Facility does not require Federal survey prior to providing services.
• Furnishing dialysis services on the main premises: ESRD requirements at § 494.180(d) require dialysis facilities to provide services directly on its main premises or on other premises that are contiguous with the main premises. CMS is waiving this requirement to allow dialysis facilities to provide service to its patients in the nursing home or skilled nursing facility. CMS continues to require that services provided to these nursing home residents are under the direction of the same governing body and professional staff as the resident’s usual Medicare-certified dialysis facility. Further, in order to ensure that care is safe, effective and is provided by trained and qualified personnel, CMS requires that the dialysis facility staff: furnish all dialysis care and services, provide all equipment and supplies necessary, maintain equipment and supplies in the nursing home, and complete all equipment maintenance, cleaning and disinfection using appropriate infection control procedures and manufacturer’s instructions for use.

04/29/202 0 5 1

• Clarification for billing procedures: Typically, ESRD beneficiaries are transported from a SNF/NF to an ESRD facility to receive renal dialysis services. In an effort to keep patients in their SNF/NF and decrease their risk of being exposed to COVID-19, ESRD facilities may temporarily furnish renal dialysis services to ESRD beneficiaries in the SNF/NF instead of the offsite ESRD facility. The in-center dialysis center should bill Medicare using Condition Code 71 (Full care unit. Billing for a patient who received staff-assisted dialysis services in a hospital or renal dialysis facility). The in-center dialysis center should also apply condition code DR to claims if all the treatments billed on the claim meet this condition or modifier CR on the line level to identify individual treatments meeting this condition. The ESRD provider would need to have their trained personnel administer the treatment in the SNF/NF. In addition, the provider must follow the CFCs. In particular, under the CFCs is the requirement that to use a dialysis machine, the FDA-approved labeling must be adhered to (§ 494.100) and it must be maintained and operated in accordance with the manufacturer’s recommendations (§ 494.60) and follow infection control requirements at (§ 494.30).

Workforce

• Dialysis Patient Care Technician certification: CMS is modifying the requirement at § 494.140(e)(4) for patient care dialysis technicians which requires certification under a State
• certification program or a national commercially available certification program within 18
• months of being hired as a dialysis patient care for newly employed dialysis patient care
• technicians. We are aware of the challenges that technicians are facing with the limited
• availability and closures of testing sites during the time of this crisis. CMS will allow patient care
• technicians to continue working even if they have not achieved certification within 18 months or
• have not met on time renewals.
•  
• Transferability of physician credentialing: CMS is modifying the requirement at §494.180(c)(1) which requires that all medical staff appointments and credentialing are in accordance with State law, including attending physicians, physician assistants, nurse practitioners, and clinical nurse specialists. CMS will allow physicians that are appropriately credentialed at a certified dialysis facility to provide care at designated isolation locations (or separate COVID-19 only facilities designed to mitigate transmission of the virus) without separate credentialing at that facility. This should be implemented so long as it is not inconsistent with a state’s emergency preparedness or pandemic plan.

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Additional Guidance

• The Interim Final Rules and waivers can be found at: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.
• CMS has released guidance to providers related to relaxed reporting requirements for quality reporting programs at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
• CMS has released guidance to describe standards of practice for infection control and prevention of COVID-19 in dialysis facilities. We also described additional flexibilities for dialysis facilities to mitigate transmission and expand home dialysis options. https://www.cms.gov/files/document/qso-20-19-esrd.pdf.

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