Keeping Your Compliance Program in Pace with Rapidly Expanding TeleHealth Services
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1 Keeping Your Compliance Program in Pace with Rapidly Expanding TeleHealth Services In April 1924, an imaginative cover for the magazine Radio News foreshadowed telemedicine in its depiction of a "radio doctor 1
2 Key Terms otelemedicine is the use of medical information exchanged from one site to another via electronic communications to improve a patient s clinical health status. Key Terms o Telemedicine is the use of medical information exchanged from one site to another via electronic communications to improve a patient s clinical health status. otelemedicine includes a growing variety of applications and services using two way video, , smart phones, wireless tools and other forms of telecommunications technology. Key Terms o Telemedicine is the use of medical information exchanged from one site to another via electronic communications to improve a patient s clinical health status. o Telemedicine includes a growing variety of applications and services using two way video, , smart phones, wireless tools and other forms of telecommunications technology. oata uses the terms TeleHealth and Telemedicine interchangeably 2
3 Brief History of Telemedicine Over 40 years ago hospitals extended care to patients in rural areas Telemedicine has rapidly expanded Integrated into ongoing operations of hospitals Specialty Departments Home Health Agencies Private Physician Offices Consumer s homes and workplaces Issue Spotting Video Conferencing v. Still Images ehealth Patient Portals Remote Monitoring Nursing Call Centers Fraud & Abuse Laws Technology Hardwire Credentialing Privileging Issue Spotting 3
4 Issue Spotting Record Maintenance Physician Licensing Identify Parties Regulatory Overlap Issue Spotting eprescribing Conditions of Participation Billing Paper Transmission & Archival Fraud & Abuse Is the service provided to the patient covered by Medicare or Medicaid? Is the service provided to the patient a DHS? Is the service provided by an entity? Pursuant to a referral? From a physician Does the physician, or physician s family member, have a financial relationship with the entity? If all answers are Yes a Stark exception must apply! 4
5 Fraud & Abuse Anti Kickback Statute (AKS) It is a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce referrals of items or services reimbursable by any federal healthcare program. Safe Harbors protect arrangements from being prosecuted, which would otherwise implicate AKS. New Safe Harbors & Exceptions Related to Telemedicine Apply to situations in which a physician receives free electronic prescribing technology or training, or free electronic health records software, or information technology or training. False Claims Act (FCA) & Civil Monetary Penalties (CMP) AKS & Stark violations are often coupled with FCA & CMP sanctions. FCA prohibits knowingly submitting or causing to be submitted false or fraudulent claims for payment or false statements or certifications to the government. 5
6 FCA & CMP Continued... CMPs apply if a person knowingly presents, or causes to be presented, to a state or federal government employee or agent any false or improper claims. FCA and CMP could apply to telemedicine activities that reach across state lines if appropriate licensure precautions are not taken. FCA & CMP Continued... FCA and CMP could apply to telemedicine activities that reach across state lines if appropriate licensure precautions are not taken. Medicare requires that the practitioner providing services & submitting a claim be licensed to provide the service by the applicable state entity. Don t forget to review State Fraud & Abuse Laws Regulatory Overlap Federal Communications Commission (FCC) Federal Trade Commission (FTC) FDA Office of the Nat l Coordinator for Health Info. Tech. (ONC) Centers for Medicare and Medicaid (CMS) 6
7 FDA Safety & Innovation Act (2012) FDA, FCC, & ONC assigned to provide an outline that will avoid regulatory duplication. April 3, 2014, draft report: Administrative and health management functions posed little risk to patient safety and required either no or limited additional oversight. Medical device health IT functions remain under FDA oversight due to recognized risks. Technology Safe Guards HIPAA, HITECH, Privacy & Security More Difficult With mhealth Encrypted Video Consultations Hardware Based, Hardwired Secure Records Transfer (fax? Mail?) Safeguards Same as In person Care HIPAA, HITECH, Privacy & Security Hosted Solutions Transfers Between Need Technical Specs Care Settings Wireless Hard to Secure Archiving Information on Devices Services Documentation Lost Devices 7
8 HIPAA, HITECH, Privacy & Security Connectivity with EHR Records Maintenance and Responsibility Participating Entities Agreements Monitor & Control Access to Patient Info Are BAAs Needed? Agreements for Privacy/Security Requirements OIG Advisory Opinions Advisory Opinion Important to remember the AOs only address risk associated with AKS not any other risks. AO is characteristic of past telemedicine AOs Although the arrangement could violate the [AKS] if the requisite intent to induce referrals were present, the OIG would not impose sanctions because of the low risk posed by the arrangement and its benefits for patients. OIG Advisory Opinions Telemedicine AOs agree: Unlikely to produce referrals Likely preexisting clinical affiliation Primary beneficiaries of the arrangement are the patients Unlikely to increase costs to federal health programs Reduces transfers Reduces disability due to delayed treatment Compare Advisory Opinions: 98 18, 99 14,
9 Physician Licensure & Portability Traditionally the Physician must be licensed in the state where the patient resides State licensure laws differ & are difficult to change Multi state licensure is possible but time consuming & costly Most States have some type of Consultation Exception Physician Licensure & Portability Proposed options/models to increase portability Consulting Exceptions Endorsement Limited Licensure Reciprocity Mutual Recognition/Compact Physician Licensure & Portability Proposed options/models to increase portability Mutual Recognition/Compact Partial Preemption by Federal Laws & Regulations National Licensure Federal Licensure 9
10 Common Provisions in State Laws & Rules Requires in person physical exam (20) Requires preexisting relationship (18) Allows physical exam & relationship to be established via telehealth (48) Requires in person follow up (3) Informed consent (15) Requires Telepresenter (6) Specifies type of provider (4) California Comparison Applicable Provisions: Requires initial in person exam Requires existing relationship Allows physical exam via telehealth (after initial exam) Verbal consent required by distant site Telepresenter must facilitate written consent onsite w/ patient Teleconsultation Exemption Applies Florida Comparison Applicable Provisions: Requires pre existing relationship Allows only MD, DO, PA Allows physical exam via telehealth (once relationship is established) Consultations for FL physicians allowed by any physician licensed in another state/country 10
11 New York Comparison Applicable Provisions: Requires existing relationship Allows physical exam via telehealth (once relationship is established) Verbal consent required by distant site Allows bordering state physician to provide telehealth to NY residents Consultation Exemption Texas Comparison Applicable Provisions: Requires initial in person exam (except when patient is located at a medical site) Requires existing relationship Allows physical exam via telehealth after initial in person exam and requires an inperson F/U visit every year Requires written consent Telepresenter required except mental health Licensed MD, DO, PA, & NP Billing, Coding and Payment Medicare Subject to restrictions Geographic Service Expansion efforts continue Recent changes in coverage CMS added to the list of covered telehealth services (Oct 2014) 11
12 Billing, Coding and Payment Medicaid Generally more restrictive than Medicare Varies by State Special programs Specific areas of need are targeted American Telemedicine Association provides State by State policy information Billing, Coding and Payment Private Payors Coverage varies greatly Changes are small but frequent Opportunities Monitor changes to Medicare and Medicaid coverage Establish communication channels with major payors in your area to stay up to date with coverage policies Look for opportunities outside of normal payment relationships Billing, Coding and Payment Checklist for new services Where is the patient (originating site)? Where is the provider (distant site)? Medical record documentation Where will it be located (system/physical storage)? Does the CPT code require a time component? Provider should document that the services were provided through the use of telemedicine. 12
13 Billing, Coding and Payment Checklist for new services Who are the licensed/unlicensed providers at each site? Are state licensing laws and practice standards met? Is the provider eligible and appropriately credentialed and privileged? Is there a process for authorization or pre certification? Auditing and Monitoring Monitoring documentation to ensure accurate payment Track each project on a timeline Identify the start date Review charts to ensure documentation is complete At 60 to 90 days from start date Review small sample size, expanding as needed Auditing and Monitoring Monitoring documentation to ensure accurate payment Additional reviews are scheduled dependent upon results Review Clinical documentation Billing data 13
14 CMS approved CoPs & Joint Commission Standards The Joint Commission s final revision to Telemedicine Standards Approved by CMS Relates to credentialing and privileging of telemedicine practitioners in hospitals and critical access hospitals CMS approved CoPs & Joint Commission Standards Originating site has a written agreement with the distant site credentialing and privileging Both hospitals and CAHs are permitted to rely upon the credentialing and privileging decisions made by the distant site hospital or telemedicine entity (effective July 2011) 14
15 Case Study No. 1 Medical Center uses mobile technologies for in home patient care for chronic conditions that require ongoing IV catheters. ipads are used for video conferencing, data exchange, and real time intervention. The tablets give patients access to evidence based interventions, step by step home caregiving algorithms, videos illustrating home IV procedures, and infection control procedures. Case Study No. 2 Hospital provides specialty care using secure online and video based consultations including access to specialists for women s health, cancer care, and ENT. In addition, the hospital offers video based consultations using PCbased webcams and off the shelf video services. Case Study No. 3 Hospital has stroke protocol using neurologists from an on call specialists group. Immediately after patient CT scan, the Specialist, via interactive video, conducts a complete neuro assessment attending nurse helps. The neurologist explains findings, suggests treatments, oversees administration of tpa & other procedures, and periodically checks in on the patient. 15
16 Marcie R. Swenson, Regional Compliance Administrator, Intermountain Healthcare Suzie Draper, VP Business Ethics & Compliance, Intermountain Healthcare Tricia Hansen, Director of Compliance & Ethics, Intermountain Healthcare 16
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