legal/regulatory/compliance covid-19 work team...video-visits may be utilized instead of in-person...

Michelle Frazier, Chief Compliance Officer

Regulatory Waivers

Legal/Regulatory/Compliance COVID-19 Work TeamApril 11, 2020*information subject to change as additional waivers are issued or current waivers are amended

Table of Contents1. General Overview: 32. Out-of-State Providers and In-Person Care: 4-63. Telehealth: 7-134. EMTALA: 14-175. HIPAA Privacy: 18-196. Federal Stark law: 20-247. Post-Acute, Home Health, Hospice & Durable Medical Equipment: 25-338. Alternative Care Sites: 34-369. Additional Regulatory Waivers: 37-4510.Appendices: 47-61

General Overview Section 1135 of the Social Security Act authorizes the Secretary of the Department of Health and Human Services to waive or modify certainMedicare, Medicaid, Children’s Health Insurance Program and HIPAA requirements. 1135 waivers may be granted to ensure in any emergency that(a) sufficient health care items and services are available to meet the needs of individuals in the emergency areas enrolled in the Medicare,Medicaid and CHIP program, and (b) health care providers that furnish such items and services in good faith but that are unable to comply withone or more requirements may be reimbursed for such items and services and exempted from sanctions for noncompliance.

The federal administration has issued an unprecedented array of temporary 1135 waivers to respond to the COVID-19 pandemic, with the goal of:

1. Ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites

2. Remove barriers for physicians, nurses, and other clinicians to be readily hired from the community or from other states so the healthcare system can rapidly expand its workforce

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

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 related to COVID-19

Although the waivers granted during the COVID-19 public emergency have been sweeping, they need to be interpreted in the context of applicable state law and comparable state waivers. Also note that these waivers apply only during the COVID-19 publicemergency. Underlying all waivers is the ongoing expectation that standard levels of care will continue to be provided to patients. Other waiver questions should be directed to the Legal/Regulatory/Compliance COVID-19 Team.

© Aurora Health Care | 3

Out-of-State Providers and In-Person Care

WisconsinOn March 27, 2020, Governor Evers issued an emergency order (which was subsequentlymodified on April 3, 2020) that allows out-of-state licensed Providers to practice in Wisconsin ifall of the following apply:

• The out-of-state license is valid and current, unrestricted and unlimited by the credentialing body, and the Provider is not currently under investigation;

• The Provider only practices within the scope of the out-of-state license;

• The Provider’s practice is necessary for the Facility to provide health care services;

• The Facility’s immediate need prevented the Provider from obtaining a temporary or permanent Wisconsin license before beginning practice; and

• A health care provider must apply for a temporary (or permanent) health care license within 30 days of first working at a health care facility (Provider must complete a Temporary License Application and submit it to DSPS at [email protected]).

• The health care facility must notify DSPS within 10 days of a health care provider practicing at its facility (Facility must complete a Health Care Facility Notification Form and submit it to DSPS at [email protected].)

mailto:[email protected]


IllinoisIDFPR has issued two separate proclamations to temporarily allow out-of-statelicensed physicians, nurses, physician assistants, dieticians, pharmacist, professionalcounselors, physician therapists, social workers, occupational therapists, respiratorycare therapists and other clinicians to provide care to Illinois patients in hospitals, LTCfacilities, or FQHCs (or elsewhere, if specifically directed by a state agency) inresponse to COVID-19. Out-of-state licensees working in Illinois pursuant to thisorder must:• Hold a license from another U.S. jurisdiction and be in good standing;• Practice in accordance with all provisions of the applicable Illinois professional

practice act and rules relating to the standards of care;• Submit the following form to receive a temporary permit:

https://www.idfpr.com/Renewals/Apply/Forms/F2398.pdf; and• Work under the direction of the Illinois Emergency Management Agency and the

Illinois Department of Public Health pursuant to a declared disaster or in a state licensed long-term care facility, hospital, or federally qualified health center.

https://www.idfpr.com/Renewals/Apply/Forms/F2398.pdf

Telehealth

IllinoisOn March 30, 2020, the Illinois Department of Financial and ProfessionalRegulation (IDFPR) issued Guidance for Out-of-State Physicians usingTelehealth Services in Illinois.• It permits an out-of-state health care provider not licensed in Illinois

to continue to provide health care services to an Illinois patient via telehealth where there is a previously established provider/patient relationship.

• IDFPR deems such a provider to be "authorized to practice in the State of Illinois" without further need to obtain licensure in Illinois.

WisconsinOn April 1, 2020, the Wisconsin Department of Safety and Professional Services issued a Memorandumproviding Telehealth Guidance (Memo) and Frequently Asked Questions on Emergency Order 16 andRelated Orders (FAQs).

• The Memo states that if someone can practice in Wisconsin via an Emergency Order, a compact, or a temporary or permanent license, that individual can practice telehealth in Wisconsin and provide services to Wisconsin residents to the same extent as similarly licensed Wisconsin practitioners.

• The FAQs state that physicians with a current, unrestricted license from another state may practice telemedicine without obtaining a temporary or permanent Wisconsin license.

• However, the FAQs also state that other providers who wish to provide telehealth services may begin practicing immediately, but they must apply for a temporary or permanent Wisconsin licensewithin thirty days of providing telehealth services, and their employers must notify DSPS within ten days. These providers may practice telehealth within the scope of their licenses in their home states.

General GuidelinesCMS has issued broad telehealth waivers to allow for an expansive use of telehealth during the public emergency. The definition of telehealth has changed,location requirements have changed and billing rules have changed. For specific detail regarding these changes, please contact theLegal/Regulatory/Compliance COVID-19 work team.

In order to serve our communities and facilitate access to care during this state of emergency, Advocate Aurora Health, Inc. (AAH) is expanding the use ofvideo and telephone-only visits available to AAH providers in line with the waivers referenced above. This will allow AAH providers to treat patients withCOVID-19 symptoms, patients with confirmed COVID-19 diagnoses, and patients with other conditions if it is in furtherance of AAH’s goal to minimizepotential exposure and/or transmission of COVID-19 by avoiding in-person visits where possible. Therefore, expanded use of video and telephone-onlyvisits is available to AAH providers until further notice subject to the following guidelines.

When To Utilize

• Video Visits: Video-visits may be utilized instead of in-person visits when the patient has COVID-19 symptoms, a confirmed COVID-19 diagnosis or ifproviding the care via a video-visit would minimize the patient’s potential exposure and/or transmission of COVID-19.

• Telephone-Only Visits: Video-visits are the preferred modality for providing remote patient care. Telephone-only visits should only be utilized ifnecessary when the patient has COVID-19 symptoms, a confirmed COVID-19 diagnosis or if providing the care over the telephone would minimize thepatient’s potential exposure and/or transmission of COVID-19.

• Weigh Options – AAH providers may consider factors such as the patient’s previous care, urgency of the patient’s condition, lack of accessto internet for a video-visit, physical ability, lack of access to a smartphone, difficulty associated with using new technology, and other similarconsiderations when determining whether to conduct a telephone-only visit.

Requirements: Before an AAH provider can provide treatment advice to a new or an established patient via a telephone-only visit or video-visit, the AAHprovider must do the following:

• Clinical Appropriateness – Determine whether it is clinically appropriate, in his/her professional judgment, to provide treatment advice to the patientvia a telephone-only visit (i.e., can the treatment be accomplished given the limits of telephone-only communication) or a video-visit.

• Scope of Practice – Determine whether the treatment advice that may be provided during telephone-only visit or video-visit is consistent with his orher scope of practice. As a reminder, this means that Physician Assistants and Nurse Practitioners need to work within their collaborative agreements.



Issue System Position

IL and WI Licensure AAH is allowing its providers to provide care via telephone-only and video visits in IL/WI even if they are not licensed in that state

Video Visits v. Telephone-Only Visits

Video visits are the preferred modality for providing patient care remotely. Telephone-only visits should only be used under certain circumstances (e.g., patient lacks access to the internet, patients doesn’t have access to smart phone, etc.)

Video Visits with New Patients Video visits should only be conducted with new patients physically located in IL or WI. If the new patient is physically located in state outside of IL or WI, they must be licensed in the state in which the patient is physicially located

Controlled Substances and Telephone-Only Visits

No prescribing (new, refills or adjustments) of controlled substances as part of a telephone only visit for new patients

• Such prescribing is permissible for established patients provided the prescribing practitioner has previously conducted an in-person medical evaluation of the patient and communicate with the patient via telemedicine

Controlled Substances and Video Visits

Prescriptions for controlled substances may be issued, refilled or adjusted for new or established patients via video visit if the provider is licensed in the state in which the patient is located

Non controlled substances and Video Visits/Telephone-Only

Prescriptions for non-controlled substances may be issued to:

• Established patients regardless of location and to ideally be prescribed by a provider licensed in the patient’s state of residence (IL, WI or in another state traveling)

• New patients but only if physically located in IL or WI and to ideally be prescribed by a provider licensed in the patient’s state of residence (making an exception for cross-border consistent with AAH’s position above)

Therapy and TelehealthPhysical therapists, occupational therapists and speech-language pathologies are not statutorily authorized to provide “telehealth”• CMS is putting PT/OT/SLP codes on telehealth list for the public health

emergency. But they will only be paid if performed by a physician or practitioner

Residents and TelehealthFor Advocate and Aurora Residency Programs: • ACMGE sped up use of Common Program Requirement for supervision of

telemedicine visits carried out by residents and fellows.• Permits residents/fellows to participate in use of telemedicine for care for patients• Permits supervision to be provided through telecommunications technology

• Residents are encouraged to participate in COVID-19 Call Center. Any orders entered need to be assigned to the program director or preceptor (to be determined by the program director). These actions are not billable

• Virtual clinic visits, if billable, require direct supervision unless it is in a primary care exception clinic in which case indirect supervision is allowed

• It is highly recommended that virtual visits that are not billable are supervised directly as well

EMTALA

EMTALA Waiver• Waiver removed hospital sanctions for limited aspects of medical

screening exams (MSE) and transfers*

• Retroactive to March 1, 2020 and in effect until end of national emergency

• Hospitals with capacity and capabilities must continue to accept transfers from hospitals without capacity and/or capability to stabilize patients

* Note that this waiver applies to ED sites on hospital campuses. See Alternative Care Site section for emergency waivers related to these locations.


EMTALA Waiver• Under the EMTALA Waiver, EDs may:

• Redirect patients to an on-site or off-site location for an MSE• Redirection must be provided by clinical staff (e.g., RN)• Redirection may occur outside of the ED entrance

• Conduct MSEs by telehealth• Must be monitored by third-party clinical team member (e.g. RN)

• Transfer non-stable patients• Transfer must be necessitated by circumstances created due to national

emergency© Aurora Health Care | 16

EMTALA WaiverDespite the Waiver, EDs may not:

• Have non-clinical staff perform redirection to on-site or off-site MSE locations

• Redirect patients that present with an emergency medical condition (EMC)

• Fail to perform a MSE wherever the patient is seen (ED, on or off-site) to determine whether an EMC is present*

• Transfer without:• agreement to accept by receiving hospital • completed transfer form• medical records

* If it is determined the patient does not have an EMC, the EMTALA obligation has ended © Aurora Health Care | 17

HIPAA Privacy

HIPAA Privacy Rule Waivers: During this time of emergency, the following HIPAA Privacy Rule requirements are not enforced. We should still follow our normal practices where reasonable, but should err on the side of patient and team member safety in making that determination:

• Distribution of the Notice of Privacy Practices• Honoring requests to opt-out of the facility directory• Obtaining patient agreement to speak with individuals involved in the patient’s care• Patient’s right to request privacy restrictions• Patient’s right to request confidential communications

Uses and Disclosures of PHI by Business Associates for Public Health and Health Oversight Activities in Response to COVID-19: Business associates may use or disclose, in good faith, PHI for public health activities or health oversight activities, provided the business associate notifies the covered entity within ten (10) calendar days after the use or disclosure occurs. Examples of good faith disclosures include those for or to the: Centers for Disease Control and Prevention (CDC) and Centers for Medicare and Medicaid Services (CMS).

HIPAA Privacy and Security Telehealth Waivers: Health care providers can use non-public facing remote audio or video communication technology platforms to provide telehealth to patients during the COVID-19 nationwide public health emergency even though some of these technologies, and the manner in which they are used may not fully comply with the requirements of the HIPAA rules. Telehealth can be used to examine a patient exhibiting COVID-19 symptoms or treat any other non-COVID medical conditions.

Allowable Non-Public Facing Applications:• AAH Zoom and AmWell are the AAH sanctioned communication methods• Allowance of additional methods of communication may evolve as needed (such products include Apple FaceTime, Facebook Messenger,

video chat, Google Hangouts video, or Skype)

Providers should notify patients that these third-party applications potentially introduce risks, and providers should enable all available encryption and privacy modes when using such applications.

NOTE: AAH-employed clinicians may use personal devices for video visits, but they must use the AAH-approved platform on these devices. While it may be acceptable under current regulatory waivers to use non-public facing platforms, such as Facetime, Skype and Facebook Messenger, for patient-care video visits, it is not acceptable for AAH-employed clinicians to do so. AAH has a platform that is fully functional and meets all pre-COVID-19 regulatory and privacy requirements. No other platforms will be supported by the IT department. © Aurora Health Care | 19

Stark & Anti-KickbackPhysician Compensation

CMS has waived sanctions for Stark noncompliance and to be covered under thewaiver, remuneration and referrals must be:• Directly between the entity and (a) the physician or the physician’s organization or (b) the

physician’s immediate family member• Furnished in good faith absent a government finding of fraud and abuse• Solely related to COVID-19 purposes in the United States (can be directly or tangentially

related)

For purposes of this waiver, COVID-19 purposes means:

1. Diagnosis or medically necessary treatment of COVID-19 for any patient or individual, whether or not the patient orindividual is diagnosed with a confirmed case of COVID-19

2. Securing the services of physicians and other health care practitioners and professionals to furnish medicallynecessary patient care services, including services not related to the diagnosis or treatment of COVID-19, in responseto the COVID-19 outbreak

3. Ensuring the ability of health care providers to address patient and community needs due to the COVID-19 outbreak

4. Expanding the capacity of health care providers to address patient and community needs due to the COVID-19outbreak

5. Shifting the diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak

6. Addressing medical practice or business interruption due to the COVID-19 outbreak in order to maintain theavailability of medical care and related services for patients and the community


Specifically, the blanket Stark waivers remove sanctions for referrals and claims related to the following 18 categories:1. Remuneration from an entity to a physician that is above or below fair market value for services personally performed by the physician to the entity

2. Rental charges paid by an entity to a physician that are below fair market value for the entity’s lease of office space from the physician

3. Rental charges paid by an entity to a physician that are below fair market value for the entity’s lease of equipment from the physician

4. Remuneration from an entity to a physician that is below fair market value for items or services purchased by the entity from the physician

5. Rental charges paid by a physician to an entity that are below fair market value for the physician’s lease of office space from the entity

6. Rental charges paid by a physician to an entity that are below fair market value for the physician’s lease of equipment from the entity

7. Remuneration from a physician to an entity that is below fair market value for the use of the entity’s premises or for items or services purchased by the physician from the entity

8. Remuneration from a hospital to a physician in the form of medical staff incidental benefits that exceed current limits

9. Remuneration from a entity to a physician in the form of nonmonetary compensation that exceeds current limits

10. Remuneration from an entity to a physician resulting from a loan to the physician with an interest rate below fair market value or on terms that are unavailable from a lender that is not a recipient of the physician’s referrals or business generated by the physician

11. Remuneration from a physician to an entity resulting from a loan to the entity with an interest rate below fair market value or on terms that unavailable from a lender that is not in a position to generate business for the physician

12. The referral by a physician owner of a hospital that temporarily expands its facility capacity above the number of operating rooms, procedure rooms and beds for which the hospital was licensed on March 23, 2010 without prior application or approval of the expansion of facility capacity

13. Referrals by a physician owner of hospital that converted from a physician-owned ambulatory surgical center to a hospital on or after March 1, 2020, under certain circumstances

14. The referral by a physician of a Medicare beneficiary for the provision of designated health services to a home health agency under specific circumstances

15. The referral by a physician in a group practice for medically necessary designated health services furnished by the group practice in a location that does not qualify as a “same building” or “centralized building”

16. The referral by a physician in a group practice for medically necessary designated health services furnished by the group practice to a patient in his/her private home, an assisted living facility or independent living facility where the referring physician’s principal medical practice does not consist of treating patients in their private homes

17. The referral by a physician to an entity with which the physician’s immediate family member has a financial relationship if the patient who is referred resides in a rural area

18. Referrals by a physician to an entity with whom the physician has a compensation arrangement that does not satisfy the writing or signature requirements of an applicable exception but satisfies each other requirement of the applicable exception, unless such requirement is waived above

Examples of allowable arrangements under this waiver include, but are not limited to:

• Compensation of physicians above previously contracted rates for providing professional services to COVID-19 patients in challengingenvironments

• Hospital providing free use of medical office space on the hospital campus to allow the physicians to timely treat patients who present at thehospital but do not need inpatient care

• Entity providing free telehealth equipment to a physician practice to facilitate telehealth visits during a social distancing, isolation or quarantineperiod

• Entity selling or providing PPE to a physician, or permitting a physician to use space, including a makeshift location, at below FMV rates or evenat no charge

• Hospital lending money to a physician practice that provides exclusive anesthesia services at the hospital to offset lost income resulting fromthe cancellation of elective procedures to ensure capacity to deal with COVID-19 needs

• Hospital providing non-monetary compensation to a physician in excess of yearly limit of $423, such as CME related to COVID-19, supplies,food or other grocery items, hotel rooms for isolation or respite needs, child care or transportation

• Hospital providing meals, comfort items (for example, a change of clothing), or onsite child care with a value greater than $36 per instance tomedical staff physicians who spend long hours at the hospital during the public emergency

• With state approval (if required), a physician-owned hospital temporarily converts observation beds to inpatient beds or otherwise increases itsinpatient bed count to accommodate patient surge during the COVID-19 outbreak

• Physician compensation arrangement that commences prior to the required documentation of the arrangement in writing and the signatures ofthe parties, but that satisfies all other requirements under the exception, for example:

• Physician provides call coverage services to a hospital before the arrangement is documented and signed by the parties

• Physician with in-office surgical capability delivers masks and gloves to the hospital before the purchase arrangement is documented andsigned by the parties

• Physician establishes an office in a medical office building owned by the hospital and begins treating patients who present at the hospital forhealth care services but do not need hospital level care before the lease agreement is documented and signed by the parties

Anti-Kickback StatuteOIG will exercise its enforcement discretion not to impose administrative sanctions under the anti-kickback statute for arrangements covered by the Stark waivers. • Applies to COVID-19 related financial relationships and referrals • Still an intent based statute

Effective April 3, 2020, expiring at the same time of Stark waivers

Post-Acute, Home Health, Hospice & DME

Post-AcuteDischarge Planning for Hospitals. 42 C.F.R. §482.43(c) CMS has waived the following requirements related to post-acutecare services for patients discharged home and referred for HHAservices or transferred to a SNF, IRF or LTCH, that the Hospital:• Include in the discharge plan a list of HHAs, SNFs, IRFs, or

LTCHs available to the patient• Inform the patient of their freedom to choose among

participating Medicare providers and suppliers of post-dischargeservices; and

• Identify any HHA or SNF to which the patient is referred in whichthe hospital has a disclosable financial interest.

Post-AcuteDischarge Planning for Hospitals:

Impact of waivers: These waivers will facilitate discharges in the event there is a shortage of facilities able or willing to accept transfers from hospitals of patients during the COVID 19 pandemic. Despite the waivers, best practices would require that to the extent possible, the hospital continue to work with a patient or substitute decision maker to meet patient choice provided patient needs are met.

How to proceed: If a patient does not have a HHA or SNF preference, refer patients (a) for home care to Advocate Home Health in Illinois and Aurora At Home in Wisconsin or (b) to SNFs participating in the Post-Acute Care Network.

Post Acute Reporting Requirements: CMS has waived the requirement toprovide detailed information regarding discharge planning asoutlined in 42 C.F.R. §482.43(a)(8), §482.61(e), and485.642(a)(8), described below:• Assisting patients/families in selecting a post-acute care

provider by using and sharing data that includes, but is notlimited to, HHA, SNF, IRF, or LTCH data on quality measures anddata on resource use measures. The hospital must ensure thatthe post-acute care data on quality measures and data onresource use measures is relevant and applicable to thepatient's goals of care and treatment preferences


Home Health OASIS

• Extends the 5-day completion requirement for the comprehensive assessment (OASIS)

• Waives the 30-day OASIS submission requirement

Initial Assessments- 42 C.F.R. § 484.55(a): initial assessments and determination of homebound status may be completed remotely or by record review.

Homebound definition expanded:

A beneficiary is considered homebound when their physician advises them not to leave theirhome because of a confirmed or suspected COVID-19 diagnosis or if the patient has acondition that makes them more susceptible to contract COVID-19. As a result, if abeneficiary is homebound due to COVID-19 and needs skilled services, an HHA can providethose services under the Medicare Home Health benefit.


Home HealthPlan of Care and Certifying/Recertifying Eligibility: discretion being used re: section 409.43 and 424.22 to allow NP/CNS, working within state law, to:

• Order home health services

• Establish/review POC

• Certify/re-certify eligibility

HHS will not audit to insure only physician orders for these services.

Onsite visits for Aide Supervision in 484.80(h):

• Waived requirements that:• A nurse conduct an onsite visit every two weeks• A nurse/other professional conducts an onsite visit every two weeks to evaluate if aides are providing care consistent with the care plan.

• 2-week aide supervision requirement by a RN for HHAs, is temporarily suspended, but virtual supervision is encouraged during the period of thewaiver.

• State waived in person supervisory visits every 2 weeks. Visits may be made via electronic or telephonic means, where available.

Telehealth: Can provide more services to beneficiaries using telehealth within the 30 day episode of care, so long as it’s part of the patient’s plan of careand does not replace needed in-person visits as ordered on the plan of care. CMS acknowledges that the use of such technology may result in changes tothe frequency or types of in-persons visits outlined on existing or new plans of care.

Medicaid: Non-physician practitioners may order medical equipment, supplies and appliances, home health nursing and aide services, and PT, OT or speechservices in accordance with state scope of practice laws.


Hospice Comprehensive Assessments: Timeframes for updates to the comprehensive assessment (§418.54(d)) is extended from 15 to 21 days

Non-Core Services: Requirement for hospices to provide certain non-core hospice services during the national emergency, including PT, OT, and speech-language pathology (§418.72) is waived

Onsite visits for HHA and Hospice & Aide Supervision in 42 CFR 418.76 (h):

• Waived requirements:

• A nurse conduct an onsite visit every two weeks

• A nurse/other professional to conduct an onsite visit every two weeks to evaluate if aides are providing care consistent with the care plan

• Waived 2-week aide supervision requirement by a RN for HHAs, but virtual supervision is encouraged during the period of the waiver


HospiceTelehealth: • Hospice providers can provide services to a Medicare patient receiving

routine home care through telehealth, if it is feasible and appropriate to do so.

• Face-to-face encounters for purposes of patient recertification for the Medicare hospice benefit can now be conducted via telehealth.

Use of Volunteers: requirement for hospices to use volunteers is waived (including at least 5% of patient care hours) (42 CFR §418.78(e))


Durable Medical EquipmentLost/damaged replacement: Where Durable Medical Equipment Prosthetics, Orthotics, andSupplies (DMEPOS) is lost, destroyed, irreparably damaged, or otherwise rendered unusable,contractors have the flexibility to waive replacement requirements such that the face-to-facerequirement, a new physician’s order, and new medical necessity documentation are notrequired. Suppliers must still include a narrative description on the claim explaining thereason why the equipment must be replaced and are reminded to maintain documentationindicating that the DMEPOS was lost, destroyed, irreparably damaged or otherwise renderedunusable or unavailable as a result of the emergency

Signature Requirements: Signature and proof of delivery requirements are waived for PartB drugs and Durable Medical Equipment when a signature cannot be obtained because of theinability to collect signatures. Suppliers should document in the medical record theappropriate date of delivery and that a signature was not able to be obtained because ofCOVID-19


Alternative Care Sites

Generally, CMS has waived certain regulations to allow for surge sites or alternative care sites. A work grouphas been dedicated to the designation of the sites for Advocate Aurora. The following are some specificwaivers that apply to these sites, but to ensure consistency, please contact the Legal/Regulatory/Compliancework team with questions before moving forward with the establishment of such sites.

Physical Environment: CMS has waived certain requirements 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, providedthat the location is approved by the State (ensuring safety and comfort for patients and staff are sufficiently addressed)and so long as it is not inconsistent with a state’s emergency preparedness or pandemic plan. This allows for increasedcapacity and promotes appropriate co-horting of COVID-19 patients.

Temporary Expansion Locations: For the duration of the public health emergency related to COVID-19, CMS has waivedcertain requirements under the Medicare conditions of participation and the provider based department requirements toallow hospitals to establish and operate as part of the hospital any location meeting those conditions of participation forhospitals that continue to apply during the PHE. This waiver also allows hospitals to change the status of their currentprovider-based department locations to the extent necessary to address the needs of hospital patients as part of the stateor local pandemic plan. This extends to any entity operating as a hospital (whether a current hospital establishing a newlocation or an Ambulatory Surgical Center (ASC) enrolling as a hospital during the PHE pursuant to a streamlinedenrollment and survey and certification process) so long as the relevant location meets the conditions of participation andother requirements not waived by CMS. This waiver will enable hospitals to meet the needs of Medicare beneficiaries.


Written Policies and Procedures for Appraisal of Emergencies at Off Campus HospitalDepartments Serving As Surge Sites. CMS has waived the requirement that for emergencyservices, with respect to surge facilities only, such that written policies and procedures for staff touse when evaluating emergencies are not required for surge facilities. This removes the burden onfacilities to develop and establish additional policies and procedures at their surge facilities or surgesites related to the assessment, initial treatment and referral of patients. These flexibilities may beimplemented so long as they are not inconsistent with a state’s emergency preparedness orpandemic plan.

Emergency Preparedness Policies and Procedures at Surge Sites: CMS has waived therequirement that hospitals and critical access hospitals develop and implement emergencypreparedness policies and procedures and the requirement that the emergency preparednesscommunication plans for hospitals and critical access hospitals to contain specified elements withrespect to the surge site. The requirement under the communication plan requires hospitals andcritical access hospitals to have specific contact information for staff, entities providing services underarrangement, patients’ physicians, other hospitals and volunteers. This would not be an expectationfor a surge site.


Additional Regulatory Waivers

Telehealth cost-sharing: Office of Inspector General has waivedenforcement of Federal anti-kickback statute, civil monetary penaltyand exclusion laws related to kickbacks for waiver of cost-sharingamounts associated with telehealth, such as coinsurance anddeductibles.• Can, but need not, collect• Private plans are inconsistent in their position on this

Transportation: OIG has issued a message on minimizing burdenson providers and maximizing flexibility so that providers are able tofocus on the delivery of patient care during the public healthemergency. Given this message and the cost-sharing flexibility above,it is the system’s position that payment for transportation upondischarge may be provided during the public emergency.


Replacement Prescription Fills: Medicare payment may bepermitted for replacement prescription fills (for a quantity up tothe amount originally prescribed) of covered Part B drugs incircumstances where dispensed medication has been lost orotherwise rendered unusable or unavailable due to theemergency

Sterile Compounding: Allows used face masks to be removedand retained in the compounding area to be re-donned andreused during the same work shift in the compounding areaonly


Verbal Orders. CMS has waived requirements to allow for additional flexibilities relatedto verbal orders where read- back verification is still required but authentication mayoccur later than 48 hours.

Specifically, the following requirements are waived:• §482.23(c)(3)(i)- If verbal orders are used for the use of drugs and biologicals

(except immunizations), they are to be used infrequently• §482.24(c)(2) - All orders, including verbal orders, must be dated, timed, and

authenticated promptly by the ordering practitioner or by another practitioner whois responsible for the care of the patient

• §482.24(c)(3)- Hospitals may use pre-printed and electronic standing orders, ordersets, and protocols for patient orders

• §485.635(d)(3)- Although the regulation requires medication administration bebased on a written, signed order, this does not preclude the CAH from using verbalorders. A practitioner responsible for the care of the patient must authenticate theorder in writing as soon as possible after the fact


Reporting Requirements. CMS has waived the requirements which requirehospitals to report patients in an intensive care unit whose death is caused by theirdisease process but who required soft wrist restraints to prevent pulling tubes/IVsmay be reported later than close of business next business day, provided any deathwhere the restraint may have contributed is continued to be reported withinstandard time limits.

Patient Rights. CMS has waived requirements only for hospitals which areconsidered to be impacted by a widespread outbreak of COVID-19. Hospitals thatare located in a State which has widespread confirmed cases (i.e., 6-50 or moreconfirmed cases)would not be required to meet the following requirements:• 42 C.F.R. §482.13(d)(2) with respect to timeframes in providing a copy of a medical

record

• 42 C.F.R. §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

• 42 C.F.R. §482.13(e)(1)(ii) regarding seclusion© Aurora Health Care | 41

Medical Staff. 42 C.F.R. §482.22(a) and §485.627(a).CMS has waived theserequirements to allow for physicians whose privileges will expire to continuepracticing at the hospital or CAH and for new physicians to be able to practice in thehospital or CAH before full medical staff/governing body review and approval

Medical Records Timing. 42 C.F.R. §482.24(c)(4)(viii) and §485.638(a)(4)(iii). CMShas waived these requirements related to medical records to allow flexibility incompletion of medical records within 30 days following discharge and for CAHs thatall medical records must be promptly completed

Flexibility in Patient Self Determination Act Requirements (AdvanceDirectives): CMS has waived the requirements which require hospitals and CAHs toprovide information about its advance directive policies to patients. This would notapply to the requirements at §482.13(a) for hospitals and at §485.608(a) for CAHs toreceive information about the presence of a policy regarding the facility’s recognitionof advanced directives


Physician Services. CMS has waived requirements under 42 CFR §482.12(c)(1)–(2) and§482.12(c)(4), which requires that Medicare patients be under the care of a physician.

Anesthesia Services. CMS has waived requirements under 42 CFR §482.52(a)(5),§485.639(c) (2), and §416.42 (b)(2) that a certified registered nurse anesthetist (CRNA) isunder the supervision of a physician. CRNA supervision will be at the discretion of thehospital and state law. This waiver applies to hospitals, CAHs, and Ambulatory SurgicalCenters (ASCs). These waivers will allow CRNAs to function to the fullest extent of theirlicensure, and may be implemented so long as they are not inconsistent with a state’semergency preparedness or pandemic plan.

Utilization Review. CMS has waived certain requirements under 42 CFR §482.1(a)(3)and 42 CFR §482.30 which address the statutory basis for hospitals and includes therequirement that hospitals participating in Medicare and Medicaid must have a utilizationreview plan that meets specified requirements.

CMS has waived the entire utilization review condition of participation Utilization Review(UR) at §482.30, which requires that a hospital must have a UR plan with a UR committeethat provides for a review of services furnished to Medicare and Medicaid beneficiaries toevaluate the medical necessity of the admission, duration of stay, and services provided.


Quality Assessment and Performance Improvement Program. CMS has waived 42 CFR §482.21(a)–(d) and (f), and §485.641(a), (b), and (d), which provide details on the scope of the program, the incorporation, and setting priorities for the program’s performance improvement activities, and integrated Quality Assurance & Performance Improvement programs (for hospitals that are part of a hospital system). This waiver applies to both hospitals and CAHs

Nursing Services. CMS has waived the requirements at 42 CFR §482.23(b)(4), which requires the nursing staff to develop and keep current a nursing care plan for each patient, and §482.23(b)(7), which requires the hospital to have policies and procedures in place establishing which outpatient departments are not required to have a registered nurse present. These flexibilities apply to both hospitals and CAHs §485.635(d)(4)

Food and Dietetic Services. CMS has waived the requirement at paragraph 42 CFR §482.28(b) (3), which requires providers 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.

Respiratory Care Services. CMS has waived the requirements at 42 CFR §482.57(b)(1) that require hospitals to 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.


Practitioner Enrollment

Non-Waiver CMS Action: CMS has a toll-free hotline for physicians and non-physician practitioners and Part A certified providers and suppliers establishing isolation facilities to enroll and receive temporary Medicare billing privileges.

Waive the following screening requirements:• Application Fee – (to the extent applicable).• Criminal background checks associated with fingerprint-based criminal background

checks (FCBC) (to the extent applicable) – 42 CFR §424.518.• Site visits (to the extent applicable) – 42 CFR §424.517.

Postpone all revalidation actions.

Allow licensed providers to render services outside of their state of enrollment.

Expedite any pending or new applications from providers.

Allow physicians and other practitioners to render telehealth services from their home without reporting their home address on their Medicare enrollment while continuing to bill from their currently enrolled location.

Allow opted-out physicians and non-physician practitioners to terminate their opt-out status early and enroll in Medicare to provide care to more patients.


Thank YOU for Listening• We continue to receive outstanding suggestions through

the inbox• We have a team looking at all of these ideas and we are

getting them to the appropriate teams who are working on specific items

• We will continue to do these provider briefings to keep you up to speed on this fluid situation.

[email protected]


Appendix ATelehealthMalpractice Insurance

Definitions Description Policy LimitsWI Physician Policy Covers physicians practicing in WI with separate policy limits $1M per occurrence / $3M aggregate

WI Entity Policy Shared policy limits covering all other clinical providers, including but not limited to NP’s, PA’s, RN’s, Techs, et al.

$1M per occurrence / $3M aggregate

Injured Patients & Families Compensation Fund (Fund)

State operated excess malpractice insurance that provides coverage in excess of the WI policies above

Unlimited

IL Hospital Policy Covers all providers practicing in a hospital setting in Illinois. Includes separate limits for physicians.

$1M per claim / $3M aggregate

IL Captive Policy Covers physicians and clinicians providing services outside of the hospital. $1M per claim / $3M aggregate

Physician State Service Type Patient State Malpractice InsuranceWI Inpatient IL WI Physician Policy & Fund

WI Tele/Video IL WI Physician Policy & Fund

IL Inpatient WI WI Physician Policy & Fund

IL Tele/Video WI IL Captive Policy

Non-Physician Provider State Service Type Patient State Primary InsuranceWI Inpatient IL IL Hospital Policy

WI Tele/Video IL WI Entity Policy

IL Inpatient WI WI Entity Policy & Fund

IL Tele/Video WI IL Captive Policy

Appendix BTelehealthBilling and Coding

Billing and CodingThe following guide applies to professional billing. For hospital billing on the UB04, there currently is no mechanism to capture a facility fee. CMS has indicated that it looking into this and there may be coverage issued in the near future. An exception is that outpatient anti-coagulation clinics may charge a facility fee when the patient is counseled by a pharmacist by phone.


List of Medicare Telehealth Services

legal/regulatory/compliance covid-19 work team...video-visits may be utilized instead of in-person...

Documents