telemedicine credentialing and privileging: minimizing liability,...

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Presenting a live 90-minute webinar with interactive Q&A

Telemedicine Credentialing and Privileging:

Minimizing Liability, Protecting Patient

Privacy, Ensuring Quality Care

Today’s faculty features:

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

THURSDAY, OCTOBER 29, 2015

Richard D. Barton, Partner, Procopio Cory Hargreaves & Savitch, San Diego

Alma L. Saravia, Shareholder, Flaster/Greenberg, Cherry Hill, N.J.

Kim C. Stanger, Partner, Holland & Hart, Boise, Idaho

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www.flastergreenberg.com Go Flaster.

Presented by:

Alma L. Saravia, Esq. October 26, 2015

New Jersey | Cherry Hill Linwood

Pennsylvania | Philadelphia

New York | Manhattan Pleasantville

Delaware | Wilmington

Telemedicine Credentialing and Privileging CLE Webinar


Center for Medicare and Medicaid Services (CMS) Telemedicine Credentialing Rules

CMS’ regulations on telemedicine credentialing and privileging were issued on May 5, 2011.

Old rules were “duplicative and burdensome” for physicians and small hospitals which lacked the resources to conduct a traditional credentialing process for the providers who may provide telemedicine services at their hospital.

6


CMS REGULATES TELEMEDICINE SERVICES IN HOSPITALS AND CRITICAL ACCESS HOSPITALS (CAH)

Effective July 5, 2011, hospitals and CAHs which offer telemedicine services (originating site) may rely on the privileges and credentials of the home hospital, also known as the distant-site hospital, which grants privileges to a physician providing telemedicine services.

Rules should permit the “advancement of telemedicine nationwide” and it will benefit patients in small hospitals or rural areas.

Rules provide accountability to patients by assuring that physicians/practitioners are privileged based on competence.

7


What is Telemedicine?

Telemedicine: Delivery of specialty care at a distance via telecommunications using applications that provide direct patient care.

CMS Definition: Telemedicine is the “provision of clinical services to patients by practitioners from a distance via electronic communications.”

American Telemedicine Association Definition:

• Telemedicine is the “use of medical information exchanged from one site to another via electronic communications to improve patients’ health status”.

8


What is Telemedicine? (con’t)

The Joint Commission (JC) Definition:

• Use of medical information exchanged from one site to another via electronic communication to improve patients’ health status. Telemedicine is a subcategory of telehealth.

Federation of State Medical Boards Definition:

• Practice of medicine using electronic communications, information technology or other means between a licensee in one location, and a patient in another location with or without an intervening healthcare provider.

9


What is a distant-site telemedicine entity?

A distant-site telemedicine entity is defined as an entity that:

1. provides telemedicine services;

2. is not a Medicare-participating hospital; and

3. provides contracted services in a manner that enables a hospital or CAH using its services to meet all applicable Conditions of Participation (CoP), particularly those requirements related to the credentialing and privileging of practitioners providing telemedicine services to the patients of the hospital or CAH.

10


Organizations Supporting the New Rules

The JC worked closely with CMS on the rule.

The American Hospital Association said “[t]his wasn't everything we wanted, but it is a big step forward.”

The American Telemedicine Association stated that the rules will help patients receive needed care no matter where they live.

11


Medicare CoP for Hospitals and CAHs

Regulatory modifications to the CoP found at:

• 42 CFR 482.12(a)(8) & (a)(9)

(Hospital Governing Body)

• 42 CFR 482.22(a)(3) & (a)(4) & (a)(6)

(Hospital Medical Staff)

• 42 CFR 485.616(c)

(Critical Access Hospitals)

12


New Credentialing and Privileging Process

The Governing Body of Hospitals and CAHs whose patients are receiving telemedicine services may choose to have its Medical Staff rely on the privileging and credentialing decisions made by a distant-site hospital or distant-site telemedicine entity when granting privileges to practitioners providing telemedicine services, provided there is a written agreement that complies with all specified requirements.

• 42 CFR 482.22(a)(3)

13


What Must be in the Written Agreement

Rules require a distant-site hospital or a telemedicine entity to use a credentialing and privileging process that at least meets the Medicare standards that hospitals have traditionally been required to use.

• 42 CFR 482.12(a) and 42 CFR 482.22(a)

14


Distant-Site Hospital/Telemedicine Entity Responsibilities (con’t)

The distant-site’s Governing Body is responsible for meeting the requirements of

• 42 CFR 482.12(a)(1)-(a)(7) [for hospitals];

• 485.616(c)(1)(i)-(c)(1)(vii) [for CAH]; and

• 42 CFR 482.12(a)(1)-(a)(7) and 482.22(a)(1)-(a)(2) [for Telemedicine Entities].

The requirements are:

1. Determine which categories of practitioners are eligible candidates for appointment to the medical staff;

15


Distant-Site Hospital/Telemedicine Entity Responsibilities (con’t)

2. Appointing members of the medical staff based on the recommendations of the existing medical staff;

3. Assuring that the medical staff maintains and enforces bylaws;

4. Approving all medical staff accountable for quality of care;

5. Ensuring medical staff members are selected based on individual character, competence, training, experience, and judgment; and

6. Ensuring that medical staff member selection is not based solely on the applicant’s certification, fellowship, or membership in a specialty body or society.

16


The Rules Permit Reliance

Permits a hospital’s or CAH’s Governing Body to rely on

credentialing and privileging decisions made by distant-site hospitals or telemedicine entities when making privileging decisions for practitioners who provide telemedicine services, as long as certain conditions are met.

• 42 CFR 482.12(a)(8)-(9); 485.616(c)(2), (4)

17


Written Agreement Must Ensure Privileges Granted

Distant-site hospital or telemedicine entity must grant privileges to the individual telemedicine physicians and practitioners providing telemedicine services.

Distant-site hospital must provide a current list of the physician’s or practitioner’s privileges.

18


Physicians and Practitioners Must be Licensed

Distant-site telemedicine physicians or practitioners must hold a license issued or recognized by the State where the hospital or CAH is located.

This is one of the most controversial aspects of the Rules.

19


Written Agreement Must be Provided if Requested

Hospitals and CAHs using telemedicine services must be provided with the telemedicine service agreement upon request when surveyed.

Originating-site hospital or CAH must send the distant-site hospital information for use in the periodic appraisal of the physician or practitioner (physicians, nurse practitioners, physician assistants, nurse-midwives, clinical nurse specialists, psychologists and clinical social workers, registered dieticians or nutrition professionals).

Adverse events or complaints must be reported.

20


Distant-Site Hospital/Telemedicine Entity Responsibilities

42 CFR 482.22(a)(1) and (a)(2) require the Medical Staff to:

• periodically conduct appraisals of its members.

• examine credentials of candidates for Medical Staff membership and make recommendations to the Governing Body on appointment of candidates.

• in lieu of these requirements a hospital may rely upon the distant-site hospital.

21


Elements of a Written Agreement with a Distant-Site Telemedicine Entity

To rely on the credentialing and privileging decisions by a distant-site telemedicine entity, the hospital or CAH must have a written agreement that establishes the following:

1. The entity’s process and standards for assessing that the qualifications of its physicians/practitioners at least meet those standards set forth in the CoPs.

2. The distant-site practitioner has the experience and expertise as represented by the distant-site telemedicine entity.

22


Elements of a Written Agreement with a Distant-Site Telemedicine Entity (con’t)

3. The practitioner holds a license issued or recognized by the state in which the hospital or CAH is located.

4. The hospital or CAH that credentials and privileges the distant-site practitioner shares the physician’s or practitioner’s performance review information with the entity.

42 CFR 482.22(a)(4); 485.616(c)(4)

23


JC ‘s Reaction to CMS’ Telemedicine Rule

JC worked with CMS to align its telemedicine requirements for hospital and CAH accreditation.

JC made revisions to requirements related to credentialing and privileging of telemedicine practitioners in hospitals and CAHs.

24


JC Requirements

Revisions appear in the Elements of Performance of the Leadership and Medical Staff standards related to the Medicare CoP requirements -

• Element of Performance 23: Requires hospitals that use Joint Commission accreditation for deemed status purposes to have written agreements with distant-site hospitals.

• Leadership Standard: LD.04.03.09 Care, treatment and services provided through contractual agreement must be provided fairly and effectively.

25


JC Requirements (con’t)

Hospital’s Medical Staff must recommend which clinical services may be appropriately delivered by licensed independent practitioners through telemedicine.

JC Standard MS.13.01.03

Licensed independent practitioners who are responsible for the care, treatment, and services of the patient via telemedicine link are subject to the credentialing and privileging processes of the originating site.

JC Standard MS.13.01.01

26



Through one of the following mechanisms:

1. Fully privilege and credential practitioner; or

2. Privilege practitioner using credentialing information from distant-site, JC accredited organization; or

3. Use credentialing and privileging decision from distant-site to make final privileging decision if all requirements are met.

27



A distant-site practitioner must have a license that is issued or recognized by the state in which the patient is receiving telemedicine services.

EP 13.01.01

28


Hospital Medical Staff ByLaws: Telemedicine Requirements

Hospital Medical Staff Bylaws must include the following:

• Criteria for determining the privileges to be granted to practitioners.

• The Joint Commission Standard MS.06.01.05; 42 CFR 482.22(c)(6).

• A procedure for applying the criteria to practitioners requesting privileges.

• The Joint Commission Standard MS.01.01.01; 42 CFR 482.22(c)(6).

29


Hospital Medical Staff ByLaws: Telemedicine Requirements (con’t)

Example Language:

Credentialing and privileging providers of telemedicine services may be fulfilled by written agreement with a contracted hospital or telemedicine entity in which the provider has been fully privileged and credentialed in accordance with Medical Staff Bylaws and Policies.

30


Challenges Ahead

• Physician Licensing;

• Physicians must have licenses from each state in which they practice telemedicine;

• State laws are conflicting about the scope of practice; and

• Licensing process is lengthy and expensive.

31


Solutions to Physician Licensing Issues

American Telemedicine Association has advocated for a national telemedicine license.

On April 26, 2014, the Federation of State Medical Boards adopted a Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine (Model Policy).

32

http://library.fsmb.org/pdf/FSMB_Telemedicine_Policy.pdf

http://library.fsmb.org/pdf/FSMB_Telemedicine_Policy.pdf


Federation’s Model Policy

The Model Policy addresses concerns of state medical boards including establishing a physician-patient relationship, appropriate online medical care, HIPAA compliance and patient privacy, and prescribing drugs based on a telemedicine encounter.

State medical boards are not required to adopt the Model Policy.

Boards may use it to guide their thinking on telemedicine even without wholesale adoption.

33


Questions?

Alma L. Saravia, Esq. (856) 661-2290

[email protected]

34

Telemedicine Credentialing and Privileging

II. Impact on Healthcare Facilities, Entrepreneurs, and Practitioners

Richard D. Barton

Partner

Procopio, Cory, Hargreaves & Savitch LLP

[email protected]

II. Impact on Healthcare Facilities,

Entrepreneurs, and Practitioners

•Bylaws and Policies

•Drafting Written Agreements

•Monitoring Performance of Providers

•Protecting Privacy Amid New Technology

36

Revising Medical Staff Bylaws & Creating Hospital Policies

• General Rule- Not all Telemedicine

arrangements are the same!!!

• CoP’s allow for different models

• Providers are creating arrangements to fit

different business needs

• Bylaws and policies must ensure that different

models are accounted for

37

• CMS Final Rule Allows for:

– Distant Site credentialing relied upon by Originating

Site

– Telemedicine entity credentialing relied upon by

Originating Site

– Originating Site credentialing and privileging


(Cont.)

38


(Cont.)

Medical Staff Bylaws Must Include:

•Separate category for Telemedicine providers

•Criteria for determining the privileges to be granted to

individual practitioners

•Procedure for applying the criteria to individuals requesting

privileges

•For Distant Site physicians and practitioners requesting

privileges to furnish Telemedicine services under an

agreement with the hospital, the criteria for determining

privileges and the procedure for applying the criteria are also

subject to the requirements in 42 CFR §§ 482.12(a)(8) and

(a)(9), and §§ 482.22(a)(3) and (a)(4)(d).

39

Bylaws Should Also Include:

•Definition of Telemedicine and scope of privileges

•Categories of privileges and/or membership to be granted

to Distant Site practitioners

•Distant Site providers must meet qualifications for

medical staff appointment

•Responsibilities – Responsible for providing Telemedicine at the request of appointees

to medical staff

– NOT Responsible for attending meetings, etc.

•Prerogatives- e.g., no admitting privileges


(Cont.)

40


(Cont.)

• Must address process for credentialing & privileging

Distant Site practitioners and

• Must keep up with changes & provide adequate

mechanisms for evaluating competence of

Telemedicine provider – Bylaws and policies must allow for adequate evaluation of

applicants

– Burden must be on applicant to provide adequate information for

recommendation

– Challenges with providers associated with medical groups and

Telemedicine entities

– Process should include appropriate medical staff review and

conform to credentialing process

– Ongoing peer review

– Procedural rights

41

Negotiating Written Agreements And Minimizing Risk

Exposure

When an Originating Site is relying upon a Distant Site for

credentialing and privileging, 42 CFR 482.12 and 482.22

contain specific requirements that:

• A written agreement is in place

• The specific provisions that must be included in the written

agreement, e.g.,

– Distant Site medical staff credentialing and privileging

process and standards at least meet the standards at §§

482.12(a)(1) through (a)(7) and §§ 482.22(a)(1) through

(a)(2);

– Distant Site physician or practitioner is privileged at the

Distant Site Telemedicine entity which provides the hospital

with a current list of the Distant Site physician's or

practitioner's privileges at the Distant Site Telemedicine

entity;

42


Exposure (Cont.)

– Distant Site physician is appropriately licensed

– Distant hospital has evidence of an internal review of the

Distant Site physician and sends the performance

information for use in the periodic appraisal of the Distant

Site physician or practitioner. At a minimum, this information

must include:

• All adverse events that result from the Telemedicine services

provided by the Distant Site physician or practitioner to the

hospital's patients, and all complaints the hospital has received

about the Distant Site physician or practitioner.

43


Exposure (Cont.)

• Written agreement must address structure of the arrangement

– Must take into account whether a hospital or entity providing the service

– Subcontractors?

• Representations and warranties must address

– Scope of service and practitioners

– Training and education

– Equipment

• Who provides and maintains on the respective sites

• Process if failure

• Liability for damage or failure

• Guidelines for sharing of information, including credentialing, adverse event &

complaints

• Insurance, defense & indemnification

• Mutual cooperation

• Contractual performance, cure & termination

44

Monitoring Telemedicine Practitioners To Assess Quality

Of Care

• Originating Site hospitals are obligated to monitor Distant

Site practitioners

• 42 CFR § 482.22 mandates sharing of information when

Originating Site relying upon Distant Site for credentialing

• CoP’s less clear when Originating Site assumes

obligations for credentialing and privileging

– Bylaws must accommodate differing models

– Contract should ensure access to quality data from

Distant Site hospital, entity, or practitioner

45

Monitoring Telemedicine Practitioners To Assess Quality

Of Care (Cont.)

Miller v. Imaging on Call 2015 WL 150287 (D. Conn. Jan. 12, 2015)

•Clear designation of responsibilities for:

– Communications with Telemedicine practitioners

– Corrective actions

– Reporting requirements

– Risk & defense

46

Protecting Patient Privacy Amid Technological Advancements

• HIPAA & HITECH

• State Laws

• FTC regulator of information privacy

– Update security risk analyses

– Data management policies

– Procedures for data usage

– Procedures for quality assessments and

communications

47

Richard D. Barton

Partner

Procopio, Cory, Hargreaves & Savitch LLP

(619) 515-3299

[email protected]

48

Additional Compliance and

Implementation Considerations

Tele-health

Kim C. Stanger

State Requirements

Must comply with state laws in addition to COP

telemedicine rules.

• Licensure

• Credentialing

• Remote Prescribing

• Liability Issues

– Standard of care

– Consent

– Patient relationship

– Insurance

– Others

50

Licensure

• Distant site provider must be

authorized to practice in

originating state, e.g.,

– Licensure

– Limited telemedicine license

– Exception to licensure laws,

e.g., consultations

– VA physicians

See www.fsmb.org/pdf/grpol_

telemedicine licensure.pdf

• Consequences:

– Unauthorized practice of

medicine.

• Criminal fines

• Prison

• Administrative penalties

– Denial of payment.

– Negligent credentialing.

– Loss of liability insurance.

– COP violations.

51

Licensure

Hospital conditions of participation (“COPs”).

• “In all cases, healthcare professional must be legally authorized to practice in the state where the hospital is located.”

• “When telemedicine is used and the practitioner and patient are located in different states, the practitioner providing the patient care service must be licensed and/or meet the other applicable standards that are required by the state or local laws in both the state where the practitioner is located and the state where the patient is located.”

(Interpretive Guidelines for 42 CFR 482.11, .12 and .22)

52

Licensure

• Most state Medicaid laws require that practitioner is

licensed within the state as condition for reimbursement.

• “Medicaid guidelines require all providers to practice

within the scope of their State Practice Act. Some states

have enacted legislation that requires providers using

telemedicine technology across state lines to have a valid

state license in the state where the patient is located. Any

such requirements or restrictions placed by the state are

binding under current Medicaid rules.” (http://www.medicaid.gov/Medicaid-CHIP-Program-

Information/By-Topics/Delivery-Systems/Telemedicine.html)

53

Licensure

• Interstate Medical Licensure Compact

– Allows expedited licensure for physicians licensed in another state

that is a member of the compact.

54

Credentialing and

Privileging

• Some states may not allow

credentialing by proxy.

– State statutes or licensing regs may still

require individual credentialing.

– Credentialing by proxy may not represent

the standard of care.

• Potential negligent credentialing

liability.

• Medical staff bylaws may require

individual credentialing.

* Check your state laws and bylaws.

55

Restrictions on Remote

Prescribing or Treating

56

Restrictions on Remote Prescribing

• Early internet pharmacies were prescribing based solely on

online questionnaires or similar methods.

• In response, many states or medical boards require an in-

person physical exam before allowing the practitioner to

prescribe or render treatment.

– Medical practices act

– Statement of medical boards

See http://www.fsmb.org/pdf/InternetPrescribing-

law&policylanguage.pdf.

• Check relevant laws concerning in-person contact.

57

http://www.fsmb.org/pdf/InternetPrescribing-law&policylanguage.pdf



AMA Guidelines for Telemedicine

• American Medical Ass’n (“AMA”) developed recommended

Ethical Guidelines for Telemedicine Services.

– Suggested that patient-physician relationship should be

established through face-to-face examination by:

• in-person contact, or

• real-time audio and video technology.

– Excepts consultations, radiology, and pathology.

• However, AMA’s House of Delegates has currently tabled

the resolution.

61

Liability Issues

• Different procedures

• Practitioner-patient relationship

• Applicable standard of care

• Informed consent

• Patient abandonment

• Liability insurance coverage

• Others

62

Different Procedures

• If crossing state boundaries, may be sued in other state’s

court or federal court under different procedures and

standards.

– Pre-litigation screening panel

– Notice of tort claims

– Pleading punitive damages

– Physician-patient privilege

– Peer review privilege

– Evidentiary rules re experts or others

63

Practitioner-Patient Relationship

• Practitioner-patient relationship may exist even though

there is no direct contact.

• Test: would reasonable patient believe that practitioner-

patient relationship exists?

– Direct contact or communication with patient.

– Contract or agreement to provide care.

– Bills for services.

• Some states may have an exception for “consultations” if

certain standards are satisfied, e.g.,

– No direct contact with patient.

– No bill for services.

64

Malpractice Liability

• Applicable standard of care

– Different community standard may apply.

– Presumably, remote practitioner must comply with the same

standard of care as a practitioner at the originating site.

• Beware:

– Is use of telemedicine appropriate for patient’s care?

– Sufficiency of telemedicine equipment or technology.

– Training and qualifications of users.

– Effect of other laws.

– Vicarious liability for others, including remote practitioner and

originating site personnel.

65

Informed Consent

• Informed consent from patient or representative is critical.

– Know the relevant laws for effective, informed consent.

– Informed consent should include:

• Discussion of risks, benefits, and limitations of telemedicine

services, including availability of services and provider,

technical limitations, etc.

• Identify persons involved in providing care.

• Whether you will record telemedicine sessions.

• Privacy or security of data communications system, especially if

use open network.

– Disclaim responsibility for entities that are not your

agents.

66

Patient Abandonment

• May be liable for abandoning patient if fail to give patient

sufficient time to transfer care.

– Tort liability for patient abandonment

– Medical Practices Act violation

• To avoid potential abandonment claim:

– Ensure patient understands scope and limits of

practitioner’s involvement in care.

• Informed consent

• Written agreement or notice

– Give patient adequate notice and time to transfer care

before terminating relationship.

67

Liability Insurance Coverage

• Liability insurance may require proper license for coverage.

• Liability insurance policies may exclude:

– Injuries from services other than face-to-face encounter.

– Injuries from unauthorized practice of medicine.

– Legal actions due to unauthorized practice of medicine.

• Administrative or licensure actions

• Criminal actions

– Practice medicine in another state.

– Regulatory violations resulting from telemedicine, e.g.,

HIPAA violation, FDA violation.

* Check your malpractice insurance coverage.

68

Reimbursement

• Medicare: slowly expanding.

– Bills routinely submitted.

– Coverage for limited services.

– Must comply with specific requirements.

• Medicaid: states determine coverage.

– Most provide some coverage for telemedicine.

• Private payers

– 27 states require private insurers to cover telemedicine

service to the same extent as face-to-face

consultations.

69

Other

Regulations

• Food and Drug Administration (“FDA”)

• Federal Communications Commission (“FCC”)

• Federal Trade Commission (“FTC”)

• Office of National Coordinator for Health

Information Technology

70

New Guidance and Guidelines

• National organizations continue to issue guidance, e.g.,

– Federation of State Medical Boards (“FSMB”)

• Model Policy for the Appropriate Use of Telemedicine Technologies.

• Interstate Licensure.

– American Medical Ass’n (“AMA”)

• Telemedicine Policy

– American Telemedicine Ass’n (“ATA”)

• Clinical Guidelines for Tele-ICU Operations

• Core Operational Guidelines for Telehealth Services Involving Provider-

Patient Interaction

– Food and Drug Administration (“FDA”)

• Guidance on Mobile Medical Applications

• Safety Communication on Cybersecurity for Medical Devices and Hospital

Networks

71

New Guidance and Guidelines

• New guidance may help to—

– Encourage change in existing statutes and regulations.

– Provide guidance for implementing telemedicine.

– Modify the standard of care in telemedicine cases.

• But we’re not there yet!

– Guidance is good, but the law is still the law.

72

Implementing Telemedicine

• Review the proposed technology and providers to ensure it

is appropriate and providers are qualified.

– Equipment

– Providers

– Technician

– Patients

– Reimbursement

• Is the use of telemedicine consistent with the applicable

standard of care?

• Need

• Cost

• Indications for use

• Limitations or restrictions

• Maintenance

• Risks

• Compliance

73


• Appoint a telemedicine program manager.

• Ensure secure communication channels.

• Build in redundancy and backup for critical applications.

• Create appropriate policies, procedures and protocols

similar to non-telemedicine.

• Educate and train personnel re appropriate use of

telemedicine.

• Have ready access to qualified IT personnel.

• Develop quality improvement process to identify needed

improvements and react to changes.

74


Available at

https://www.healthit.gov

/sites/default/files/teleh

ealthguide_final_0.pdf

75

https://www.healthit.gov/sites/default/files/telehealthguide_final_0.pdf




Available at

http://www.telehealth

resourcecenter.org/site

s/main/files/file-

attachments/complete-

program-developer-kit-

2014-web1.pdf

76

http://www.telehealthresourcecenter.org/sites/main/files/file-attachments/complete-program-developer-kit-2014-web1.pdf
















Contracting with Vendors

• Protect against liability for equipment failure.

• Ensure access to continued support services.

• Obtain representations and warranties concerning

compliance with regulatory requirements, e.g.,

– HIPAA

– FDA medical devices

– Other

• Business associate agreement if vendor creates,

maintains, accesses or transmits PHI.

• Other terms. 77

Questions?

Kim C. Stanger

Holland & Hart LLP

[email protected]

(208) 383-3913

78

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