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Posts Tagged ‘Telehealth’

Telemedicine IT Donations and the Anti-kickback Statute – OIG Opinion 18-03

Monday, October 29th, 2018

IT Donation to Facilitate Telemedicine Consultations – Low Risk of Fraud says OIG

telemedicine donation it The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 18-03 in support of an arrangement where a federally qualified health center look-alike (the “Provider”) would donate free information technology-related equipment and services to a county health clinic (the “County Clinic”) to facilitate telemedicine encounters with the County Clinic’s patients (the “Proposed Arrangement”).  The OIG concluded that although the Proposed Arrangement could potentially generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law (“CMPL”) with the requisite intent to induce or reward referrals of federal health care programs, the OIG would exercise its discretion and not sanction the Provider or the County Clinic (collectively the “Requestors”).

The OIG’s analysis and conclusion of the Proposed Arrangement provides new insight into the government’s position on these type of donations that facilitate telemedicine encounters.  Specifically, how the government views these type of donations with the continued expansion of coverage and reimbursement of telemedicine services under federal health care programs.  The Advisory Opinion indicates support for the development of collaborative telemedicine affiliations and that the potential remuneration from the future referrals can be outweighed by the access to health care services and benefits actually received by rural or remote communities.

The County Clinic is a division of the County Department of Health that furnishes certain confidential sexually transmitted infection testing, treatment and counseling. The Provider has an existing referral relationship with the County Clinic but the facilities are separated by about 80 miles making it difficult for patients to access the Provider.  Under the Proposed Arrangement, the Provider would donate information technology-related equipment and services to the County Clinic to facilitate telemedicine encounters between the Provider and the County Clinic’s patients for certain HIV prevention and treatment services.  The Provider would cover the costs of the equipment, its set up, and maintenance through grant-funding from the State Department of Health.  The Provider would bill the Medicare program for the professional services delivered in the telemedicine encounters.  The County Clinic would house the equipment and bill the state Medicaid program an originating site fee related to the telemedicine encounters. The originating site is not required to provide any personnel or equipment in order to bill for the facility fee (Q3014) (which is only a coverage requirement to provide the telehealth consult).

 

OIG Analysis

Under the Proposed Arrangement, the County Clinic would receive remuneration of the free equipment and services and the Provider would have the opportunity to bill for the telehealth consultation referred by the County Clinic.  As such, the OIG acknowledged that the Proposed Arrangement could potentially generate prohibited remuneration under the federal AKS with the requisite intent to induce or reward referrals of services payable by a federal health care program.  However, the OIG identified the following factors as minimizing the potential risk of fraud and abuse:

  • There are safeguards in place to prevent patient steering to the Provider for treatment; namely use of technology with any other provider is not restricted and patients are given the option to have either a virtual or in-person consultation
  • Not likely to result in patient steering for prescriptions to any pharmacy operated by the Provider or County Clinic
  • There would be no increased cost to any federal health care program
  • Patients would benefit by having increased access to treatment; making it more likely that patients will seek out and receive such services

It is important to keep in mind that under the Proposed Arrangement the County Clinic would not obtain ownership of the equipment, as the Provider would use grant funds awarded by the State Department of Health to cover the costs of the equipment and services and the state agency would retain title and have the authority to recover the equipment at any time.  This could prove to be an important distinction concerning whether and how donating providers can provide information technology-related equipment and services to referring facilities in the other arrangements.

In prior Advisory Opinions (99-14, 04-07 and 11-12) concerning donations of information technology-related equipment and supplies, the OIG similarly concluded that it would not pursue sanctions; however, those proposed arrangements would not have directly resulted in a service payable by a federal health care program, but rather would only potentially result in other items or services to the patient by the donating provider. Under the Proposed Arrangement, both the County Clinic and the Provider would be in a position to submit claims to a federal health care program as a result of the telemedicine encounter and follow-up services.  Nevertheless, the OIG concluded that there would be no increased cost to any federal health care program because the County Clinic would have performed the preliminary tests and referred clinically appropriate patients for in-person consultations and, potentially, follow-up items and services regardless of the Proposed Arrangement.

While the analysis acknowledges the additional reimbursement the County Clinic would receive for serving as the originating site (i.e., the location of the Medicaid beneficiary when the service furnished via a telecommunications system occurs), there is no actual analysis of this facility fee and why it is not considered an increased cost.  To be clear, the County Clinic does not provide the HIV preventative services to be delivered by the Provider via the telemedicine consultation, and therefore, would not have previously received any payments if and when the patient was referred to the Provider for an in-person consultation.

Again, it appears that the OIG is willing to prioritize the health benefits to patients over any secondary or tertiary benefits to the referring provider; especially when such subsequent benefits are unlikely to result in over-utilization and have the potential to decrease costs to federal health care programs.

Telehealth Certification In Wisconsin Mental Health Programs

Tuesday, August 11th, 2015

Process for Telehealth Certification In Wisconsin

Only certified mental health and/or substance abuse programs, or agencies planning to be certified as a mental health and/or substance abuse provider, may apply for telehealth certification. The first step in the process is for the agency to write a plan addressing each section in the attached template. The plan is then sent to the Behavioral Health Certification Section of the Division of Quality Assurance.

Provider’s must demonstrate compliance with their approved plan to the Division of Quality Assurance surveyor(s) during a site review or other unannounced focus visits.

Requirements for Telehealth Certification

There are several requirements that must be met in order to maintain certification.  Many of these requirements will need to be reflected in compliance policies and made operational as part of the telehealth program. These requirements fall in the following areas subject to additional detail in each area:

  • applicable regulatory requirements for the provider’s specific program (Administrative Code DHS 34, 35, 36, 40, 41, 61, 63, and 75)
  • requirements related to clinical supervision/collaboration for program staff who provide treatment services via telehealth, background checks, maintenance of professional liability insurance, documentation into the consumer’s record in a timely manner, and other requirements.
  • requirements regarding the locations for staff other than the main office of certified program or a certified branch office. Patients must receive the telehealth services at the main office or a certified branch office of the certified program.
  • Restriction against providing the telehealth services to consumers who are in-home or in-community.
  • minimum transmission standards established by the American Telemedicine Association (see http://www.americantelemed.org/resources/telemedicine-practice-guidelines/telemedicine-practice-guidelines)
  • compliance with vendor requirements for the telehealth hardware/software to ensure that the telehealth service is of high quality and as close to a face to face visit as possible.
  • orientation and ongoing training to staff on the use of the telehealth equipment, the clinical application of telehealth, safety and security during telehealth visits, privacy and confidentiality, back-up procedures if there is equipment failure, and consumer preparation for telehealth.
  • Assuring that patients are informed about the provision of services provided through telehealth, the history of telehealth, success rate of telehealth services, how telehealth sessions are conducted, and the extent to which the program is able to provide treatment services face-to-face versus via telehealth.
  • an ongoing method for obtaining consumer satisfaction on telehealth visits and evaluating the results of this survey process for quality assurance purposes
  • patient choice of having a face to face visit with a professional or seeing this person via telehealth, to the extent feasible.
  • workspaces must be secure, private, reasonably soundproof, and have a lockable door to prevent unexpected entry.
  • Efforts to ensure privacy so provider discussion cannot be overheard by others outside of the room where the service is provided.
  • If other people are in either the patient or the professional’s room, both the program staff and the consumer must be made aware of the other person and agree to their presence.
  • Program staff must verify for the consumer the identity of the staff member who is providing the treatment services via telehealth and verify for the staff member providing the treatment services theconsumer’s identity.
  • policy/procedure for technology breakdown that causes a disruption of the session.
  • System to Ensure secure upload and download with the vendor’s server.  At least 128 bit encryption software must be used.
  • assure that no information from a transmission of a telehealth services is stored on the vendor’s servers.
  • use of HIPAA Business Associate Agreement if information is transmitted via the vendor’s servers.

How Does Wisconsin Medicaid Reimburse for Telehealth?  Check Out The Article Here: Telemedicine Reimbursement Mental Health Programs

New Memorandum On Telehealth In Mental Health and Substance Abuse Programs

Tuesday, August 11th, 2015

 

On August 5, 2015 the  the Wisconsin Division of Quality Assurance (DQA), issued new DQA Memo 2015-011 (the “Telehealth Memorandum”) to provide background information and update a previous memo (Memo #2004-14, issued in September 2004) on the use of telehealth in certified mental health and substance abuse treatment programs/services in the State of Wisconsin.

Recognizing that significant technological advances have been made since the earlier memo, the DQA details revisions to the minimum requirements for telehealth certification by mental health and substance abuse programs in the State of Wisconsin.  The new standards for certification purport to permit use of hardware and software that may be less costly and easier to use.  This may result in facilitating broader use of telehealth to benefit patients with the state of Wisconsin.

The Telehealth Memorandum outlines basic certification requirements and references the application form for Mental Health and Substance Abuse Telehealth certification for additional detail.  Specific requirements are outlined  that certified mental health and substance abuse treatment programs must follow in order to use telehealth technology as a means of service provision for counseling, psychotherapy, medication management or related clinical consultation.  Services may include outpatient services, crisis services, community support services, comprehensive community services, day treatment programs, inpatient, and other services.

Some of the requirements that must be met in order to achieve certification of a telehealth program in Wisconsin include the following:

  • All staff employed by these programs may provide services using telehealth technologies provided they have received the necessary training and meet program and telehealth certification standards.
  • The certified program should identify specific staff providing the services in its telehealth plan and policies as required in the certification process.
  • Telehealth services cannot be provided in Wisconsin by narcotic treatment services certified under Chapter DHS 75.15 or mental health inpatient services certified under Chapter DHS 61.71 and Chapter DHS 61.79.
  • Telehealth technology cannot be used in lieu of the face-to-face assessment for continuing use of the restraint/seclusion in an inpatient setting.
  • Telehealth equipment may be used for the purpose of clinical supervision and clinical collaboration.
  • All the requirements for supervision and collaboration continue to apply such as transmission quality, ensuring that the transmitted information is not stored, and other requirements and restrictions outlined in DQA guidance.
  • The memo cautions providers regarding the use of telehealth equipment for clinical supervision for substance abuse counselors which require at least one in-person meeting per month.

Credentialing Rules for Telemedicine Providers

Thursday, April 17th, 2014

Telemedicine Credentialing CMS Credentialing Rules

Credentialing Telemedicine providersAt the present time, CMS conditions of participation are the primary regulatory source governing the process of credentialing telemedicine providers.  The Joint Commission has revised its requirements to be consistent with CMS rules.  In regulations dated May 5, 2011 (effective July 5, 2011), CMS provided final regulations that somewhat streamline the credentialing process and which comply with the Medicare Conditions of Participation.  CMS regulations give providers some options regarding credentialing of telemedicine including:

  • Retaining complete credentialing of all telemedicine providers using the credentialing process that is applicable to all other medical staff members.  The direct credentialing option is still the safest route for hospital’s to take from a liability standpoint.
  • Rely on the credentialing decision of another Medicare certified hospital when granting telemedicine privileges, subject to certain specific conditions including entering into a written agreement with the other facility.
  • Rely on the credentialing decisions of other “telemedicine entities” when granting telemedicine privileges, subject to certain conditions including entering into a written agreement.

In short, provided that all of the specific requirements contained in CMS regulations are met, a receiving hospital is permitted for purposes of Medicare participation to rely on the credentialing decisions that have been made by the “distant-site” telemedicine provider.  Note, however, that when the other facility is located out of state, the provider will still need to independently verify licensure under Wisconsin law.  The credentialing process conducted in a different state may not be a reliable source of assuring Wisconsin licensure.  In most cases, the distant-site provider will require full Wisconsin licensure to perform and permit billing for the applicable service.

ATA Issues Telemedicine Protocols for Mental Health Services

Tuesday, March 26th, 2013

ATA Proposed Telemedicine Protocols – Mental Health Video Services

telemedicine video mental healthThe American Telemedicine Association just issues a request for public comment on a draft policy that it released relative to video-based mental health services. The proposed ATA policies are intended to “detail best-practices for online mental health providers delivering video-based services through personal computers and mobile devices” according to the ATA release.

You can access the ATA proposed practice guidelines at: www.americantelemed.org/standards

You can comment to the proposed practice protocols at the following link:
www.americantelemed.org/comments

For more information regarding legal and regulatory issues affecting telemedicine and telehealth programs, contact John H. Fisher at the Ruder Ware Health Care Focus Group through the contact information on this page.

Telemedicine Resources On The Internet

Tuesday, February 12th, 2013

Sources of Telemedicine Information on the World Wide Web

Because telemedicine is a developing field, many of the legal issues regarding telemedicine are

undeveloped. As courts and legislatures attempt to tackle these issues, experts will want to stay informed of these developments. Fortunately, there are a number of useful World Wide Web sites that address telemedicine and the attendant legal issues. Some of the most useful and informative sites are:

 US Government Resources

Federal Telemedicine Gateway

http://www.tmgateway.org/

Office for the Advancement of Telehealth

US Department of Health & Human Services

http://telehealth.hrsa.gov/

Telemedicine-Related Activities Report

US Food and Drug Administration

http://www.fda.gov/cdrh/telemed.html

Telemedicine Report to Congress, January 31, 1997

US Department of Commerce and Department of Health & Human Services http://www.ntia.doc.gov/reports/telemed/cover.htm

US Department of Defense Telemedicine

http://www.matmo.org/

 

Telemedicine Associations

American Telemedicine Association – atawiki – contains an abundance of telemedicine services in Wiki format.

American Medical Informatics Association

http://www.amia.org/

American Telemedicine Association

http://www.atmeda.org

MedWeb Plus: Telemedicine (1999).

http://www.medwebplus.com/subject/Telemedicine.html

 

Telemedicine Publications

Telehealth Magazine

http://www.telemedmag.com

Telemedicine Information Exchange

http://208.129.211.51/

http://tie.telemed.org

Telemedicine Today, http://www.telemedtoday.com

Telemedicine and Telehealth Networks, http://www.telemedmag.com

Indian Health Service http://www.ihs.gov

Telemedicine Links, http://www.jma.com.au/telelink.htm#networks

Telemedicine Information Exchange, http://208.129.211.51/

United States Department of Commerce and United States Department of Health and Human Services (1997).

State Telemedicine Programs and Resources

East Carolina University School of Medicine’s Telemedicine Page

http://www.telemed.med.ecu.edu/

Emergency Medicine and Primary Care Home Page

http://www.embbs.com/

MedWeb: Telemedicine Emory University

http://WWW.MedWeb.Emory.Edu/MedWeb/

Telemedicine Links John Mitchell & Associates

http://www.jma.com.au/telelink.htm#networks Includes links to telemedicine networks, telemedicine projects, telemedicine organizations, telematics, telemedicine journals, books, articles, bibliographies, terminology.

Rural Alabama Health Alliance Telemedicine

http://www.tmgateway.org/gateway/agencies/rus/501/

University of Iowa’s Virtual Hospital

http://vh.radiology.uiowa.edu/

University of Kansas Telemedicine

http://www2.kumc.edu/telemedicine/index.asp

University of Vermont Telemedicine

http://www.vtmednet.org./telemedicine/

Health Information Tennessee

http://web.utk.edu/~chrg/hit/index.htm

Other Useful Links

Prevention

http://www.cdc.gov/cdc.html

Healthcare on the Internet Index/Abstract

http://www.personal.psu.edu/faculty/e/p/epd103/hci/

National Center for Injury Prevention and Control

http://www.cdc.gov/ncipc/osp/mortdata.htm

Sig Med Pulse, ASIS Medical Informatics Newsletter

http://www.asis.org/SIG/SIGMED/newsletter/pulsev1n3.html

Telemedicine Report to Congress, January 31, 1997, http://www.ntia.doc.gov/reports/telemed/

United States Food and Drug Administration (1997).

Telemedicine-Related Activities Report, http://www.fda.gov/cdrh/telemed.html

United States Government (1998)

The Federal Telemedicine Gateway, http://www.tmgateway.org/gateway/

Online Telemedicine Resource Links

Telemedicine Resources • Http://telehealth.hrsa.gov (OAT)

• http:www.atmeda.org (Am. Telemedicine Assn.)

 • http://telehealth.hrsa.gov/jwgt/jwgt.htm

http://transition.fcc.gov/wcb/tapd/ruralhealth/

 http://www.rurdev.usda.gov/UTP_DLTResources.html

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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