Telemedicine: The Basics And Answers to Ques6ons You Always Had But Never Asked Kelley Evans, Senior Counsel, Dignity Health Kelley.Evans@dignityhealth.org Associa6on of Corporate Counsel Health Law Sec6on November 6, 2012
The Primary Legal Issues Licensure/State Law Creden6aling Medical Staff Bylaws Providing Free Equipment Billing Miscellaneous 2
Licensure Generally prac66oners who provide the telehealth services must be licensed in the State where the services are being provided (based on pa6ent loca6on); regula6ons are State specific. The American Telemedicine Associa6on is a great resource to determine the different laws for each State. Proposed federal legisla6on to create a na6onal telemedicine license has stalled. 3
New California Law California requires the prac66oner providing telemedicine services to have a full, unrestricted California medical license. AB 415, the Telehealth Advancement Act of 2011, went into effect on January 1, 2012. This Act completely changed California Business & Professions Code 2290.5 (the statute governing telemedicine services) mostly for the be_er, and also amended certain other statutes. One of the primary purposes of the Act was to create a parity between telemedicine and other health care delivery modes. The Legislature also, through this Act, changed the term telemedicine to telehealth, and expanded its defini6on. (Please note that CMS s6ll uses the term telemedicine. ) At the last minute, through the help of the California Hospital Associa6on, this Act incorporated the new privileging and creden6aling by proxy or by contract regula6ons promulgated by CMS and Joint Commission (discussed later), which in effect overruled the California Department of Public Health prohibi6on set forth in All Facili6es Le_er (AFL) 11-33 (see AFL 12-05). 4
Telemedicine v. Telehealth Telemedicine was defined as the prac6ce of health care delivery, diagnosis, consulta6on, treatment, transfer or medical data, and educa6on using interac6ve audio, video, or data communica6ons. Neither a telephone conversa6on nor an electronic mail message between a health care prac66oner and pa6ent cons6tutes telemedicine for purposes of this sec6on. Telehealth is now defined as the mode of delivering health care and public health via informa6on and communica6on technologies to facilitate the diagnosis, consulta6on, treatment, educa6on, care management and self- management of a pa6ent s health care while the pa6ent is at the origina6ng site and the health care provider is at a distant site. Telehealth facilitates pa6ent self- management and caregiver support for pa6ents and includes synchronous interac6ons and ascynchronous store and forward transfers. 5
New DefiniCons and InteresCng DeleCons New defini6ons in California law: Origina6ng Site (some6mes called Spoke Hospital ) Distant Site (some6mes called Hub Hospital ) Synchronous Interac6on Asynchronous Store and Forward The old statute included a carve- out that the statute did not apply to the situa6on when the pa6ent is not directly involved in the telemedicine interac6on, for example when one health care prac66oner consults with another health care prac66oner. This carve- out was deleted in the new statute, which has interes6ng ramifica6ons (e.g. teleradiologists). 6
Informed Consent in California AB 415 amended Business & Professions Code 2290.5 to allow verbal informed consent rather than requiring wri_en informed consent (see California Business & Professions Code 2290.5 (b)). Now, in California, prior to the delivery of health care via telehealth, the health care provider at the Spoke Hospital shall verbally inform the pa6ent that telehealth may be used and obtain verbal consent from the pa6ent for this use. The verbal consent shall be documented in the pa6ent s medical record. This consent requirement is subject to the excep6ons to informed consent in California law (e.g. emergency situa6on). 7
California Licensure for Out- of- State PracCConers Per Business & Professions Code 2060, California has an exemp6on from licensure requirements for a prac66oner located outside of California if: the prac66oner is licensed in the State or country where the prac66oner is located, and is in actual consulta6on with a prac66oner licensed in California. The out- of- state prac66oner may not: open an office in California appoint a place to meet pa6ents, receive calls from pa6ents within California, give orders, or have ul6mate authority over the care or primary diagnosis of a pa6ent located in California. 8
Nevada Nevada permits physicians prac6cing telemedicine to hold a special purpose license (NRS 630.261(e)), provided the physician: Holds a full and unrestricted license to prac6ce medicine in another State Has not had any disciplinary or other ac6on taken against him/her by any State or other jurisdic6on Is cer6fied by a specialty board of the American Board of Medical Special6es or its successor Any physician who holds a Nevada Special Purpose Medical License may not physically prac6ce medicine within Nevada 9
Arizona Physicians in Arizona who read or interpret medical records and radiology films must hold an Arizona license But Arizona Revised Statute 32-1421(B) states that physicians residing in another State who are authorized to prac6ce medicine in that other State are not required to hold an Arizona license if the physician engages in actual single or infrequent consulta6on with an MD licensed in Arizona and if the consulta6on regards a specific pa6ent(s). 10
Texas An out- of- state telemedicine prac66oner may provide episodic consulta6ons without a Texas medical license (Tex. Occ. Code 151.056; Tex. Admin. Code 174.12); otherwise, must have Texas medical license. No6ce to Pa6ents (Tex. Admin. Code 174.5): Prior to providing telemedicine services, physicians must give no6ce regarding telemedicine medical services, including (a) the risks and benefits of being treated by telemedicine, and (b) how to receive follow- up care or assistance in the event of an adverse reac6on to the treatment, or in the event of an inability to communicate as a result of a technological equipment failure Informed Consent (Tex. Occ. Code 111.002): The trea6ng physician or health professional who provides or facilitates the use of telemedicine medical services shall ensure that the informed consent of the pa6ent, or another appropriate individual, is obtained in advance. 11
Privileging and CredenCaling Hospitals must have a privileging and creden6aling process for ALL physicians and prac66oners, including telemedicine prac66oners. Usually Medical Staffs have a special category for telemedicine privileging. Historically, creden6aling has been performed by each Spoke Hospital duplica6ve and burdensome process. The Joint Commission (TJC) and CMS now permit creden6aling by proxy, also known as creden6aling by contract i.e. the Spoke Hospitals may now rely on the creden6aling and privileging of telehealth prac66oners by the Hub Hospital. Creden6aling by contract is not mandatory; it is just a flexible alterna6ve. It is an6cipated many will take advantage of it. Such flexibility was promoted by Presiden6al Execu6ve Order 13563 (January 18, 2011). Also adopted by California Legislature (as stated above). 12
CredenCaling by Contract Joint Commission Standard Per MS.13.01.01, the Spoke Hospital fully privileges and creden6als the prac66oner according to standards MS.06.01.03 through MS.06.01.13, or The Spoke Hospital may privilege prac66oners using the creden6aling and privileging informa6on from the Hub Hospital if all of the following requirements are met: The Hub Hospital is a TJC accredited hospital; The prac66oner is privileged at the Hub Hospital for those services to be provided at the Spoke Hospital, and the Hub Hospital provides the Spoke Hospital with a current list of such privileges; and The Spoke Hospital (a) has evidence of an internal review of the prac66oner s performance of those privileges and (b) sends to the Hub Hospital informa6on useful to assess the prac66oner s quality of care, treatment and services for use in privileging and performance improvement. Such informa6on includes at a minimum all adverse outcomes related to sen6nel events considered reviewable by TJC that result from telemedicine services provided by the prac66oner and complaints about the prac66oner from pa6ents, licensed prac66oners or staff at the Spoke Hospital. 13
CredenCaling by Contract CMS Standard The new CMS standard is found in 42 CFR 482.12(a)(8) and 482.22 (see also 42 CFR 485.616 for creden6aling for Cri6cal Access Hospitals). The Hub Hospital must meet exis6ng privileging and creden6aling requirements for its prac66oners providing telemedicine services. The Spoke Hospital may rely upon the creden6aling decisions of the Hub Hospital and may grant privileges based on the privileging decisions of the Hub Hospital, provided certain language is included in a wri_en agreement between Hub Hospital and Spoke Hospital. 14
CredenCaling by Contract WriTen Agreement In order to use creden6aling by contract, CMS requires the following language in the agreement: The Hub Hospital is a Medicare- par6cipa6ng hospital, and its governing body meets the exis6ng Medicare Condi6ons of Par6cipa6on (i.e. 42 CFR 482.12(a)(1) through (a)(7)). Alterna6vely, if instead the Distant- Site telemedicine en6ty is not a Medicare- par6cipa6ng hospital, the telemedicine en6ty agrees that it is a contractor of services to the Spoke Hospital, and thus, in accordance with 42 CFR 482.12(e), agrees to furnish telemedicine services in a manner that permits the Spoke Hospital to comply with all applicable condi6ons of par6cipa6on for the contracted services, including 42 CFR 482.12(a)(1) through (a)(7). The Distant- Site telemedicine en6ty also needs to agree that its medical staff creden6aling and privileging process and standards meets the standards of 42 CFR 482.12(a)(1) through (a)(7) and 482.22(a)(1) through (a)(2). 15
CredenCaling by Contract WriTen Agreement Required language (con6nued): The Hub Hospital telemedicine prac66oner is privileged at the Hub Hospital, which provides a current list of the Hub Hospital prac66oner s privileges at the Hub Hospital. The telemedicine prac66oner holds a license issued or recognized by the State where the Spoke Hospital is located. Once the telemedicine prac66oner obtains privileges at the Spoke Hospital, the Spoke Hospital shall have evidence of an internal review of the Hub Hospital prac66oner s performance and shall send this informa6on to the Hub Hospital. At a minimum, this informa6on must include all adverse events that result from telemedicine services provided by the Hub Hospital prac66oner to the Spoke Hospital s pa6ents and all complaints received by the Spoke Hospital about the telemedicine prac66oner. These three provisions above also apply to Distant- Site telemedicine en66es that are not Medicare- par6cipa6ng hospitals. 16
CredenCaling by Contract WriTen Agreement Likewise, TJC requires the following language: The Hub Hospital is a contractor of services to the Spoke Hospital; The Hub Hospital furnishes telemedicine services in a manner that permits the Spoke Hospital to comply with the Medicare Condi6ons of Par6cipa6on; The creden6aling and privileging processes at Hub Hospital meet at a minimum the standards of 42 CFR 482.12(a)(1) through (a)(9) and 482.22(a)(1) through (a)(4); The Hub Hospital s governing body has a process that is consistent with TJC creden6aling and privileging requirements MS.06.01.01 through MS.06.01.13; and The Spoke Hospital grants privileges to the Hub Hospital prac66oner based on the Spoke Hospital s medical staff recommenda6ons, which rely on informa6on provided by the Hub Hospital. 17
CredenCaling by Contract WriTen Agreement Addi6onal language not part of CMS/TJC Standards (con6nued): Confiden6ality and privacy elements in sharing data (protec6on of peer review informa6on and other legal requirements) Indemnifica6on considera6ons 18
Medical Staff Bylaws Medical Staff Bylaws are required to include: Criteria for determining privileges to be granted to individual prac66oners Procedure to apply the criteria to individuals reques6ng privileges Medical Staff Bylaws should also address: Category for distant- site telemedicine prac66oners Level of involvement, if any, for telemedicine prac66oners in medical staff commi_ees Procedural rights of telemedicine prac66oners Hospitals should at the very least include provisions that mirror Joint Commission MS 13.01.01 to permit creden6aling by proxy. 19
Providing Free Equipment A Hub Hospital may provide laptops to physicians providing telemedicine services, even if the laptops have browser func6onality, without charge. This is based, in part, on the Community- wide Health Informa6on Systems Excep6on to Stark (42 CFR 411.357(u)) that permits an en6ty to provide IT items or services to a physician that allow access to and sharing of health informa6on in order to enhance the community s overall health. Tax exempt issues. 20
Early OIG Opinions OIG 98-18 concerned an ophthalmologist subleasing imaging equipment to an optometrist at fair market value, and providing telemedicine consulta6ons for the optometrist s pa6ents for free. Neither the ophthalmologist nor the optometrist would charge the pa6ent for the telemedicine consulta6on, and there would be no adver6sing of the telemedicine consulta6ons. OIG concluded that the lease fit within the equipment rental safe harbor, and that the telemedicine consulta6ons were of minimum value to the optometrist because there was no charge and no adver6sing. 21
Early OIG Opinions OIG 99-14 involved a health system that was opera6ng a telehealth network pursuant to a federal grant, but that wanted to develop, operate, administer and fund the network arer the grant had expired. The OIG determined that the arrangement would benefit physicians with subsidized line charges, free equipment and addi6onal opportuni6es to earn fees, but that such remunera6on was outweighed by the fact that the arrangement furthered congressional intent to promote telehealth networks in rural communi6es (thus improved access and decreased costs). OIG 04-07 involved an arrangement where health system physicians would provide free telemedicine consulta6ons at no charge for school- based clinics in low- income rural areas. OIG felt that the provision of non- reimbursable screening services that were not 6ed to reimbursable services would not violate the federal prohibi6on on inducements. 22
OIG Advisory Opinion 11-12 OIG Advisory Opinion 11-12 (issued August 29, 2011) in which the OIG stated that it would not impose administra6ve sanc6ons where a Hub Hospital, at its own expense, provided the following to certain community hospitals in the Hub Hospital s service area: Neuro- emergency telemedicine technology Neuro- emergency clinical consulta6ons Acceptance of neuro- emergency transfers Neuro- emergency clinical protocols, tracking and medical educa6on Stated purposes of the arrangement were to: reduce mortality and morbidity rates of stroke in Hub Hospital s metropolitan area, and to lower costs associated with transfer of stroke cases that could be managed at local community hospitals. 23
OIG Advisory Opinion 11-12 Agreement between the Hub Hospital and the community Spoke Hospitals stated that Hub Hospital would provide equipment and services, and in return Spoke Hospitals would agree not to par6cipate in any other neuro- emergency telemedicine service without Hub Hospital s prior approval. Neither the con6nued transfer of stroke pa6ents to the Hub Hospital nor the value or volume of any other business generated between the par6es would be a condi6on of par6cipa6on in the arrangement. Neither the Hub Hospital nor the Spoke Hospital would bill any pa6ent or third- party payor for the cost of the telemedicine technology. 24
OIG Advisory Opinion 11-12 OIG stated that this arrangement implicated the An6- Kickback Statute, and that the safe harbor for personal services and management contracts was not applicable because use of the telemedicine program would be on an as- needed basis. In order to have safe harbor protec6on, an agreement for services to be provided on a periodic or sporadic basis must specify the schedule of such intervals, their precise length and the exact charge for such intervals. 25
OIG Advisory Opinion 11-12 The OIG concluded it would not subject Hub Hospital to administra6ve sanc6ons based on the following: Hub Hospital would be unlikely to generate appreciable referrals as there was no requirement or encouragement to refer pa6ents to Hub Hospital. Neither the volume or value of the Spoke Hospital s previous or an6cipated referrals, nor the volume or value of any other business generated between the par6es would be a condi6on of par6cipa6on in the arrangement. Primary beneficiaries of the proposed arrangement would be the stroke pa6ents treated at the Spoke Hospitals through telemedicine. Such treatment would be more 6mely and effec6ve through telemedicine than transferring these pa6ents to Hub Hospital. 26
OIG Advisory Opinion 11-12 Addi6onal ra6onale behind OIG decision: Neither the Hub Hospital not any of the Spoke Hospitals would be required to engage in any marke6ng ac6vi6es, and each party would be responsible for the costs associated with its own marke6ng. The telemedicine program was unlikely to result in increased costs to the federal healthcare programs because few, if any, of the consulta6ons would be billable to Medicare. Also, the program was designed to reduce the volume of transfers of stroke pa6ents to Hub Hospital, and thus reduce the costs associated with such transfers. 27
Providing Free Home Health Equipment OIG Advisory Opinion 03-04 concerned a home health agency that proposed to provide emergency alert pagers and monitors to pa6ents served by the home health agency. The es6mated value to the pa6ents was $20-30 per month. OIG concluded that this was not an impermissible inducement. Provision of this service was reasonably related to the delivery of home health services and fostered efficiency and quality of care. 28
Billing Medicare will only reimburse for telehealth services for Medicare pa6ents that present for treatment in a Spoke Hospital that is located in a Health Professional Shortage Area (HPSA) or in a county outside of a Metropolitan Sta6s6cal Area (MSA) Medicare, however, will not currently reimburse for telehealth services delivered into the home, although Medicare does have CPT codes for remote monitoring. 29
Billing Medicaid reimbursement is managed at the State level. In California, Medi- Cal has no geographic restric6ons like Medicare. New California law states that in- person contact between the provider and the pa6ent is not required under Medi- Cal when the service is appropriately provided by telehealth (see Welfare & Ins6tu6ons Code 14132.72 and 14132.725). However, Medi- Cal Provider Manual (Oct 2008) states that there must be evidence of a barrier to receiving the services in- person (threshold for barrier is low). Under Medi- Cal, Hub Hospital bills the appropriate codes with modifier GT for live video services; Spoke Hospital only receives reimbursement if it is medically necessary for par6cipa6on of provider at pa6ent- site. Hub Hospital may also bill appropriate codes with GQ modifier for Store and Forward services (i.e. reviewed later in 6me) for teleopthalmology and teledermatology. 30
Billing Arizona Health Care Cost Containment System ( AHCCCS ) covers telemedicine services delivered either in real 6me or store and forward. Both California Medi- Cal and AHCCCS cover home health telehealth. Nevada Medicaid does not cover telemedicine services (per American Telemedicine Associa6on). Texas Medicaid covers telemedicine services provided the equipment meets minimum technical specifica6on standards, and the pa6ent being treated is located in a state hospital, a state school, or in a rural or underserved area. 31
Billing Some commercial health plans pay for telehealth services and some do not pay. Depends on contract. However, California law mandates that health plans cover services that can be adequately provided through telemedicine (Health & Safety Code 1374.13). Poten6al legisla6on at federal and State levels to change reimbursement structure. CMS has proposed adding telemedicine coverage for certain HCPCS codes in its 2013 Medicare fee schedule 32
Miscellaneous Physician- Pa6ent Rela6onship Include in agreement language when Hub Hospital provider is responsible for pa6ent care and handover back to Spoke Hospital New growing areas that present interes6ng issues: Teleobserving Teleproctoring Telementoring Telepreceptor 33
Telehealth ModaliCes InTouch Health Emerge M.D. Care Innova6ons Polycom Others 34
InTouch Health Technology 35
Mercy Telehealth Network Mercy General Hospital and Mercy San Juan Medical Center act as the Hub Hospitals or Distant Site Hospitals. The hospital receiving the telehealth services is referred to as the Spoke Hospital or OriginaCng Site Hospital. The medical services are provided by Dignity Health Medical Founda6on (DHMF) through Medical Clinic of Sacramento, Inc. (MCS). 36
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39 Services Acute Stroke Care Acute Rehabilita6on Consulta6ons Other services: Cri6cal Care/ICU Perinatal Surgical (Thoracic) Psychiatry Home Health MS Clinic (outpa6ent) Telenephrology
Conclusion My interest is in the future because I am going to spend the rest of my life there. Charles Ke*ering, American engineer and inventor of the electric starter, 1876-1958
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