The Medical Staff: Well, Now What? A Snapshot of Today and ... · •Section 1135 Waiver: Allows Temporary Hospital Expansion Locations •Waiver of certain Medicare Hospital Conditions

Presented by:

Ann C. McCullough

John T. Synowick

The Medical Staff:

Well, Now What? A Snapshot of Today and Tomorrow During the Pandemic

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Blog + Resources

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mailto:[email protected]


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Speakers

Ann C. McCullough, JD

Health Care Shareholder

Polsinelli PC, Denver CO

[email protected]

(303) 583-8202

John T. Synowicki, JD

Health Care Shareholder

Polsinelli PC, Dallas TX

[email protected]

(214) 661-5504



Well Now What...?

• Public Health Emergency

• Waivers: Federal, State, Agency• EMTALA• Temporary Expansion Locations• Stark Law• Telemedicine• HIPAA

• Temporary and Disaster Privileging

• Current Challenges

• Peer Review Obstacles and Considerations

• Communication with the Medical Staff

• Virtual Meetings

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A Few Key Data Points for United States

• Centers for Disease Control - COVID-19 (as of July 19) • Approx. 3,700,000 total cases

• Approx. 140,000 deaths

• 549 deaths of health care personnel

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html

• By November 1, 2020, nationwide death toll predictions:• Exceed 239,000 deaths (easing of mask mandates)

• Exceed 182,000 deaths (universal masks)

• Source: Institute for Health Metrics, University of Washington

https://covid19.healthdata.org/united-states-of-america

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https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html

https://covid19.healthdata.org/united-states-of-america

Public Health Emergency

• National Coronavirus Pandemic Public Health Emergency (PHE) under Public Health Services Act, 42 U.S.C. §§ 247d-6d, 247d-6e

• Secretary HHS Declared PHE January 31, 2020

• Presidential Emergency Declaration• Declared March 13, 2020

• Why do Hospitals and Medical Staffs care about Presidential Declaration and the PHE?

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• Must have both PHE and Presidential Emergency Declaration for CMS to enter waivers under Section 1135 of the Social Security Act (SSA) for:

• Medicare

• Medicaid

• Children’s Health Insurance Program (CHIP) and

• Health Insurance Portability and Accountability Act (HIPAA)

• Many State waivers expire upon expiration of the PHE

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• PHE set to expire July 25, 2020

• National Governors Association, American Hospital Association and others urged extension of PHE (and therefore, extension of Section 1135 Waivers)

• Michael Caputo, Department of HHS Spokesperson • If renewed, PHE extends for

90 days (October, 2020)

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What’s Next?

• Termination or expiration of the PHE will require termination / modification of changes, including EMTALA, telehealth, temporary expansion locations, HIPAA, leases and related agreements

• Three stages for Hospitals and Medical Staffs:• Invoke PHE waivers and flexibilities (but unwind or termination should

be part of planning)

• Unwind waivers if PHE expires (possibly on short notice)

• Potential for ongoing need will likely continue beyond termination of federal PHE – ex. COVID-19 patient separation

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Section 1135 Waivers

• “Blanket” (Nation-Wide) Waivers For Hospitals (updated July 9, 2020) https://www.cms.gov/files/document/covid-hospitals.pdf

• “Blanket” (Nation-Wide) Waivers For Health Care Providers (updated June 25, 2020) https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf

• Blanket waivers are retroactive to March 1, 2020

• Blanket waivers terminate upon termination or expiration of PHE and Presidential Declaration

• Individual Section 1135 Waiver requests • May be requested by providers and suppliers (e.g., health systems, hospitals,

trade associations, States, physicians, etc.)

• Terminate upon termination or expiration of PHE and Presidential Declaration

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https://www.cms.gov/files/document/covid-hospitals.pdf

https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf

EMTALA

• Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd (EMTALA)

• Section 1135 Waiver: CMS waived enforcement to allow hospitals to redirect patients to off-site, hospital-controlled COVID-19 screening site for EMTALA Medical Screening Examinations

• Off-site location must not be inconsistent with the State emergency preparedness or emergency plan

• CMS issued State Survey memo (See, March 30 version) https://www.cms.gov/files/document/qso-20-15-hospital-cah-emtala-revised.pdf (Do not review March 9 version, linked in Hospital Waiver)

• CMS issued FAQs April 30. https://www.cms.gov/files/document/frequently-asked-questions-and-answers-emtala-part-ii.pdf

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https://www.cms.gov/files/document/qso-20-15-hospital-cah-emtala-revised.pdf

https://www.cms.gov/files/document/frequently-asked-questions-and-answers-emtala-part-ii.pdf

EMTALA

• CMS did not waive enforcement or sanctions for transfer of individual who has not been stabilized or other EMTALA requirements

• EMTALA Medical Screening Examination locations:• Governed by EMTALA standards:

• On-campus locations

• Off-campus provider-based dedicated emergency departments

• Not governed by EMTALA standards:• Parking lot drive-through testing

• (More in the nature of triage. Not required to use qualified medical personnel)

• Off-campus provider-based locations that are not dedicated emergency departments

• Off-campus locations that are not provider-based

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Temporary Expansion Locations

• Section 1135 Waiver: Allows Temporary Hospital Expansion Locations

• Waiver of certain Medicare Hospital Conditions of Participation 42 C.F.R. § 482 (CoPs); temporary expansion location must meet the non-waived CoPs

• Waiver of Provider-Based Rules – Allows relocation of on-campus and excepted off-campus PBDs with full OPPS payment

• Empty medical office buildings, patient’s home, etc.

• All non-waived medical staff CoPs apply to the temporary hospital expansion locations

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Temporary Expansion Locations

• Ambulatory Surgery Center (ASC) – Options: • ASC may enroll as a hospital under streamlined enrollment

• All CoPs not otherwise waived still apply, including medical staff CoPs

• ASC may furnish hospital services “under arrangements” • Contractual arrangement under which the Hospital bills for services furnished by

a third party

• Caution regarding Stark Law

• All CoPs not otherwise waived still apply, including medical staff CoPs

• Hospital could also lease ASC space as temporary expansion site • All CoPs not otherwise waived still apply, including medical staff CoPs

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Stark Law

• Stark Law, 42 U.S.C. §1395nn

• Section 1135 Waivers: CMS waived Stark law referral prohibition for financial relationships that are “solely” related to the COVID-19 PHE

• Hospital or physician may pay above or below fair market value (FMV) for:• Personal services

• Rent • Items or services

• Hospital may provide benefits to Medical Staff members (e.g., meals, laundry, child care) while physicians are at the hospital and engaged in activities to benefit the hospital and its patients

• Physician owner may refer to a hospital that was converted from an ASC to a hospital

• Physician-owned hospital may expand facilities • https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf

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https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf

Critical Access Hospitals

• Section 1135 Waivers: CMS waived a number of CoPs and other requirements for Critical Access Hospitals (CAHs)

• CAH surge sites do not need to be in a rural area

• CMS waived 25 bed limit

• CMS waived 96 hour length of stay

• CMS waived the requirement that a physician (MD / DO) be physically “present” to provide medical direction, consultation and services provided in the CAH

• The physician must still be available through “direct radio or telephone communication or electronic communication for consultation, assistance with medical emergencies, or patient referrals. 42 C.F.R. 485.631(b)(2)

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Telemedicine / Telehealth

• Section 1135 Waivers: CMS expands access to telehealth services

• Waived certain CoP elements for telehealth agreements with distant-site hospitals and distant-site telemedicine entities

• Expands coverage beyond rural areas, and allow patients to receive telehealth services from their homes

• Expands they types of health care providers that may bill Medicare for telehealth services from a distant site

• CMS maintains a list of services that may be furnished via Medicare telehealth https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes

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


• Medicare Reimbursement for Telehealth• Telehealth services are paid under the Medicare Physician Fee

Schedule (MFPS) at the same rate as in-person services • Medicare coinsurance and deductible generally apply to telehealth

services but the HHS Office of Inspector General (OIG) provides flexibility for providers to reduce or waive cost sharing for telehealth services

• Reporting of telehealth E/M visits can be based on time or Medical Decision Making (MDM)

• Medicare also pays for certain non-telehealth services that are furnished using telecommunications technology: E-visits, Virtual Check-Ins, and Remote Physiologic Monitoring (RPM)

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• Telehealth technology• CMS requires most telehealth services to be furnished using

telecommunications technology that has audio and video capabilities for two-way, real-time interactive communication

• CMS waiver allows audio-only telephone evaluation and management for certain telehealth services

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• Telehealth Place of Service / Originating Site • Place of service (POS) should be selected based on where the

physician would have been if the service were provided in-person

• During the PHE, Telehealth modifier -95 should be appended to claim lines that describe telehealth services

• Services should only be reported as telehealth when the provider furnishing the service is not at the same location as the patient (“distant site”). If the provider and patient are in the same location but are using telecommunications technology due to exposure risks, the service would not be reported as telehealth but rather reported as the in-person service furnished

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• State telehealth waivers and flexibilities • Commercial payer policies vary by state. Some states have issued

emergency rules requiring state-regulated plans to pay for telehealth / telemedicine at the same rate as an in-person visit

• Many states have issued licensure waivers allowing out-of-state providers to furnish care via telehealth / telemedicine without obtaining a state license

• Some states have waived modality requirements and allow audio-only telehealth visits

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• Seema Verma, HHS: Health Affairs Blog, July 15, 2020 • More than 9 million Medicare patients had used telehealth in the period

between mid-March and mid-June

• More than 3 million of those had audio-only visits

• About 22 percent of rural Medicare patients used telehealth, compared to about 30 percent of those in urban areas

• https://www.healthaffairs.org/do/10.1377/hblog20200715.454789/full/?source=email

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https://www.healthaffairs.org/do/10.1377/hblog20200715.454789/full/?source=email


• What’s Next?• Waivers and flexibilities are currently temporary and will expire with the

PHE

• HHS reviewing possible permanent expansions of telehealth

• CMS has some authority to expand virtual care coverage, broader changes to Medicare require legislative action.

• FY2021 Medicare Physician Fee Schedule (MPFS) • Expected release July 2020

• Potential extension of telehealth waivers and flexibilities

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HIPAA

• Health Insurance Portability and Accountability Act, 42 USC 1320d (HIPAA)

• HIPAA Rules were not waived in their entirety. Waiver is limited to:• Obtaining a patient’s agreement to speak with family members or friends

involved in the patient’s care (45 C.F.R. § 164.510(b))

• Honoring a request to opt out of the facility directory (45 C.F.R. § 164.510(a))

• Distributing a notice of privacy practices (45 C.F.R. § 164.520)

• Honoring a patient’s right to request privacy restrictions (45 C.F.R. §164.522(a))

• Honoring the patient’s right to request confidential information (45 C.F.R. §164.522(b))

• All other HIPAA Rules remain in full force and effect

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HIPAA and Telehealth

• Office of Civil Rights (OCR) is exercising its enforcement discretion to not impose penalties for noncompliance with the HIPAA Rules in connection with the good faith provision of telehealth using such non-public facing audio or video communication products during the COVID-19 nationwide PHE

• Applies to telehealth provided for any reason

• Applies to all non-public facing audio or video applications

• Does not apply to public-facing applications

• Does not apply to business associates

• Should ensure all available encryption and privacy modes are enabled

• Should provide notice of privacy risks and enter into a BAA, when possible

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Telehealth and The Joint Commission

• In a recent FAQ, TJC confirmed that during a disaster, licensed independent practitioners who are currently credentialed may furnish the same services for which they are granted privileges via a telehealth link.

• This does not require any additional credentialing or privileging.

• The Medical Staff, however, must determine which services are appropriate for delivery through a telehealth link.

• And the practitioners should be trained in the use of the telehealth link and protections for privacy of patient health information under HIPAA.

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How Did We Get Here?

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Current Challenges – Snapshot

Snapshot and Current Challenges

• Temporary and disaster privileges

• NPDB reporting

• The “new normal” for medical staff operations

• Extension of current privileges

• Adjusting to the pandemic

• Call coverage

• Behavioral concerns

• Investigations and suspensions

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Current Challenges - Privileges

Privileging

• Temporary Privileges

• Disaster privileges

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Current Challenges – Temporary Privileges

Temporary Privileges

• Two circumstances where they are allowed:

1. To fulfill an important patient care, treatment, and service need, or

2. When an applicant for new privileges* with a complete application that raises no concerns is awaiting review and approval by the Medical Executive Committee (MEC) and the governing body

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Temporary Privileges – New Privileges

* “Applicant for new privileges” includes:

1. an individual applying for the first time;

2. current practitioner requesting additional privileges; and

3. an individual who is in the reappointment process and is requesting one or more additional privileges

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Temporary Privileges – Important Patient Care Need

• The second basis for temporary privileges

• The need must be documented in the credentials file at the time privileges are granted

• The need could also appear in a statement by the CEO as to the reason for granting the temporary privilege(s)

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Examples from TJC:

• The care of a patient requires specialized skills that no currently privileged practitioner possesses;

• Locum tenems need; and

• Patient care volume exceeds the level that can be handled by currently privileged practitioners

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• Failure to timely process a practitioner's reappointment application is not a reason for the use of 'important patient care need' temporary privileges

• In that situation, the hospital would need to justify and document that requiring the practitioner to stop practicing at the time of reappointment for failure to submit the application in a timely manner – or failure to process the application in a timely manner – would result in an important patient care need situation

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Current Challenges

Disaster Privileges v. Emergency Situation

• In an emergency, TJC permits any medical staff member with clinical privileges to provide any type of patient care necessary as a life-saving measure or to prevent serious harm—regardless of his or her medical status or clinical privileges—as long as the care, treatment, and services provided are within the scope of the individuals license

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Current Challenges


• E.g., if a major storm isolated a small hospital and a patient suddenly needed a specialized surgical procedure or would die, the hospital could grant emergency privileges to a general surgeon, even if he or she is not usually privileged to perform that particular procedure

• TJC Standard MS.06.01.13

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Current Challenges


• Often described in the Bylaws or Credentials Policy:

1. Define “emergency situation” – condition which could result in serious or permanent harm to a patient if any delay in treatment;

2. Permits practitioner to administer treatment to the extent permitted by his or her license; and

3. When the emergency situation ends, the patient will be assigned to an appropriate practitioner

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Current Challenges – Disaster Privileges

• Disaster privileges can only be granted to volunteer licensed independent practitioners when the organization’s Emergency Operations Plan has been activated

• A disaster is an emergency that, due to its complexity, scope, or duration, threatens the organization’s capabilities and requires outside assistance to sustain patient care, safety, or security functions

• Intended for imminent emergencies (e.g., Katrina)

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Before granting emergency privileges, the organization must:

1. Obtain a valid, government-issued photo ID, and

2. At least one of the following:• Photo ID from a health care organization that identifies professional

designation;

• A current license to practice;

• Primary source verification of licensure;

Cont’d…

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• ID indicating that the person is a member of a Disaster Medical Assistance Team (DMAT), the Medical Reserve Corps (MRC), the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP), or other recognized state or federal response organization or group;

• Identification indicating that the individual has been granted authority by a government entity to provide patient care, treatment, or services in disaster circumstances; or

• Confirmation by a licensed independent practitioner currently privileged by the hospital or by a staff member with personal knowledge of the volunteer practitioner’s ability to act as a licensed independent practitioner during a disaster

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• Once identification has been confirmed, disaster privileges are granted per the medical staff bylaws

• Oversight by the medical staff is required

• 72 hours – document reevaluation

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• Disaster privileges are valid right away

• Primary source verification occurs as soon as the disaster is under control or within 72 hours

• If over 72 hours, must be done ASAP

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• Provided as a courtesy only, and can be withdrawn by the Hospital at any time

• Disaster privileges are in place for as long as the emergency exists, but note that bylaws often limit them to 120 days

• Tip – reevaluate thereafter, and document basis for continuing disaster privileges

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Temporary Privileges

• Fulfill important patient care need

• Documented in records

• Complete application with no concerns

• NPDB

Disaster Privileges• Hospital’s emergency operations plan has

been activated• Valid, government-issued photo ID (e.g.

driver’s license, passport), • NPDB, and, • At least one of the following:• A current picture identification card from a

health care organization that clearly identifies professional designation;

• A current license to practice;• Member of Disaster Medical Assistance Team• Other government authority to provide disaster

medical care• Recommended by other member of the staff

with privileges 44

Current Challenges

Temporary Privileges – NPDB Reporting

• NPDB makes no distinction between temporary clinical privileges (including emergency and disaster clinical privileges) and clinical privileges

• However, if temporary privileges are awarded to a physician for a specific amount of time, with no opportunity for renewal, and the temporary privileges expire while the practitioner is under investigation, a report should not be submitted to the NPDB

NPDB Guidebook, E-37-38.

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Current Challenges

What does the new normal look like for medical staff?

• Has your hospital changed how it operates going forward?

• Are the changes temporary or permanent?

• How else might your hospital be affected if COVID19 rates decline?

• What if there’s a second wave in the fall?

• Are visitors allowed?

• Surrogate decision-makers – how are they consulted?• Concerns and difficulties in video conferencing

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Current Challenges – Credentialing

Credentialing Providers

• TJC permits extensions beyond 2 years, if:

1. A national emergency has officially been declared;

2. The organization has activated its emergency management plan; and

3. Extending the duration of providers’ privileges during an emergency is NOT prohibited by State Law

• Cont’d…

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Current Challenges – Peer Review

• Certain matters need to continue in the process (e.g., suspension, investigations, hearings)

• Certain matters are delayed or need to be postponed• Be careful not to delay too long

• Do you have the ability to meet as a committee? Perform an investigation?

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• The duration of the extension cannot exceed 60 days after the declared state of emergency has ended

• The organization determines how the extension will be documented

• Note – NPDB Querying

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• Our recommendation has been to try to avoid extensions

• Facility is responsible for tracking and implementing

• Try to keep up!

• May not be possible for all providers

• Understandable that certain hospitals are not providing timely responses or peer references are not coming in

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Adjusting to the Pandemic

• Peer review changes• Phone/teleconference meetings

• Confidentiality concerns

• Cross-credentialing of providers

• Conducting physician interviews• Invite the physician to the meeting room at the Hospital

• Have someone bring the physician into the room with a webcam

• Attend telephonically

• The person at the meeting can confirm once the physician has left the room

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Questions

• Do the bylaws permit telephonic/webcam attendance?

• Do the bylaws prohibit telephonic/webcam attendance?

• Is a resolution required to permit telephonic/webcam meetings?

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• Virtual meetings work

• Confidentiality Statement

• Access without print capability

• Use the chat box for recognition and questions

• Record minutes in the same way but note virtual meeting

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• Note – If your medical staff does not want to permit telephonic meetings post-COVID19 world, consider permitting them only when the emergency protocol for the Hospital has been implemented or when a State of Emergency/National Emergency has been declared

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Call Coverage

• What about physicians who refuse to cover call?

• Is Peer Review appropriate?

• Advance notice?

• Is the physician performing other cases at the hospital?

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Behavior issues

• How do we deal with disruptive physicians at this time?• What caused the disruptive behavior?

• Is there a history of this type of behavior?

• If the physician is placed on a PIP or a Behavior Contract, what are the terms of the agreement?

• PACE, Vanderbilt, KSTAR – Is the physician required to fly and attend?

• How long does the physician have to comply?

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Formal Investigations

• Are the resources available?

• Is an Ad Hoc Investigating Committee feasible?

Suspension

• If the investigation is slowed by COVID19, is a report required?

• What if it goes beyond 30 days due to investigation logistics?

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Adjusting to the Pandemic – NPDB

Is It Reportable?

• Question: My organization is extremely busy due to the COVID-19 pandemic and is unable to fully conduct investigations and hearings. If we summarily suspend a practitioner's privileges during this time, will the NPDB allow us to hold off on submitting the report until we are able to complete a full investigation?

• NPDB Insights, May 2020

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Adjusting to the Pandemic – NPDB

Answer: We recognize that these are unprecedented times and hospitals and other health care entities are facing challenges never before encountered. Similarly, there has never been a more critical moment for accurate and timely NPDB information than the current one. We remain committed to ensuring the dependability of the NPDB as a valuable workforce tool and as such will not be pausing the reporting of any required information. Health care entities are statutorily required to report any professional review action that adversely affects the clinical privileges of a physician or dentist for more than 30 days. Hence, a summary suspension meeting this statutory requirement is reportable to the NPDB. On a later date, after the investigation has been completed, if the reporting organization determines no action should have been taken and the practitioner's summary suspension is vacated, the reporting organization should void the report. However if the summary suspension is upheld and a subsequent action is taken, a revision to the action should be submitted. If you wish, you may add language to the narrative section of the report indicating an investigation relating to the summary suspension has yet to be conducted due to competing matters.

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Plan Ahead

• Did you extend physicians as allowed by TJC? Do you have a plan to get them processed once this lifts?

• Have peer review matters been pushed off – get back on track!

• Be proactive – if details are missed now, they may not be addressed later.

• Be flexible– this situation has evolved and changed and will continue to do so.

• When will this end?

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Polsinelli COVID-19 Resources

Contact

For COVID-19 legal advice across a spectrum of

issues impacting an array of industries and legal

areas, our team is available and connected

nationally and in the communities in which you

operate.

Contact us with questions at:

[email protected]

Polsinelli’s cross-disciplinary COVID-19 blog

provides companies tools and information needed

to effectively and lawfully protect their employees

and business.

Visit our blog:


Blog + Resources

61



Polsinelli provides this material for informational purposes only. The material provided herein is general and is not intended to be legal advice. Nothing herein should be relied upon or used without consulting a lawyer to consider your specific circumstances, possible changes to applicable laws, rules and regulations and other legal issues. Receipt of this material does not establish an attorney-client relationship.

Polsinelli is very proud of the results we obtain for our clients, but you should know that past results do not guarantee future results; that every case is different and must be judged on its own merits; and that the choice of a lawyer is an important decision and should not be based solely upon advertisements.

© 2020 Polsinelli PC. In California, Polsinelli LLP.

Polsinelli is a registered mark of Polsinelli PC

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Documents

The Medical Staff: Well, Now What? A Snapshot of Today and ... · •Section 1135 Waiver: Allows Temporary Hospital Expansion Locations •Waiver of certain Medicare Hospital Conditions