BILL ANALYSIS Ó AB 415 Page 1 Date of Hearing: May 3, 2011 ASSEMBLY COMMITTEE ON HEALTH William W. Monning, Chair AB 415 (Logue) - As Amended: April 25, 2011 SUBJECT : Healing arts: telehealth. SUMMARY : Revises the Telemedicine Development Act of 1996 (TDA) to update and define terminology, repeals verbal and written informed consent requirements prior to the delivery of health care via telemedicine, requires health care service plans (health plans), including those that contract with the Medi-Cal Program, and health insurers to adopt payment policies to compensate health care providers who provide covered health care services appropriately provided through telehealth. Specifically, this bill : 1)Repeals provisions in the Medical Practice Act (MPA) requiring verbal and written informed patient consent prior to the delivery of health care via telemedicine, and replaces those provisions with the definition of "telehealth," which is defined as the mode of delivering health care services and public health via information and communication technologies to facilitate the diagnosis, consultation, treatment, education, care management, and self-management of a patient's health care while the patient is at the originating site and the health care provider is at a distant site. Defines other relevant terms for the purposes of this bill. 2)Requires all laws regarding the confidentiality of health care information and a patient's rights to his/her medical information to apply to all telehealth interactions. 3)Repeals a prohibition on health plans and disability insurers that prevents them from requiring face-to-face contact between a health care provider and a patient for services appropriately provided through telemedicine, and replaces it with a prohibition on health plans and health insurers from requiring in-person contact between a health care provider and a patient before payment is made for the covered services appropriately provided through telehealth. 4)Requires every health plan, including those contracting with the Medi-Cal Managed Care Program, and every health insurer to AB 415 Page 2 adopt payment policies consistent with 3) above to compensate health care providers who provide covered health care services through telehealth, subject to the terms and conditions of the contract between the enrollee or subscriber and the health plan. 5)Prohibits a health plan, a health insurer, and the Department of Health Care Services (DHCS) from limiting the type of setting where services are provided for the patient or by the health care provider. 6)Repeals a prohibition on health plans and health insurers from being required to pay for consultation provided by the health care provider by telephone or fax. 7)Repeals obsolete provisions affecting the Medi-Cal program regarding billing codes, a 2000 report to the Legislature on the application of telemedicine to provide home health care, emergency care, critical and intensive care, and other services as potential Medi-Cal benefits and a requirement on the DHCS to obtain private or federal funding for an evaluation of the cost-effectiveness and quality of health care provided through telemedicine. 8)Prohibits DHCS from requiring in-person contact between a health care provider and a patient under the Medi-Cal Program for services appropriately provided through telehealth. 9)Authorizes DHCS to implement, interpret, and make specific 5) and 8) above by means of all-county letters, provider bulletins, and similar instructions. 10)Repeals a Medi-Cal requirement in existing law that health care providers comply with the informed consent provisions in the MPA when a patient receives teleophthalmology or teledermatology by store and forward. 11)Deletes the January 1, 2013 sunset date on existing law that authorizes teleophthalmology and teledermatology by store and forward in the Medi-Cal Program. EXISTING LAW : 1)Establishes the Medical Board of California (MBC) to exercise licensing, regulation and disciplinary functions in accordance AB 415 Page 3 with the Medical Practice Act. Defines, in the MPA, telemedicine as the practice of health care delivery, diagnosis, consultation, treatment, transfer of medical data, and education using interactive audio, video, or data communications. 2)Establishes the TDA, which broadly defines telemedicine as the use of information technology to deliver medical services and information from one location to another, and imposes several requirements governing the delivery of health care services through telemedicine. 3)Requires the health care practitioner who has ultimate authority over the care or primary diagnosis of the patient to obtain verbal and written informed consent from the patient or the patient's legal representative prior to the delivery of health care via telemedicine, except when the patient is not directly involved in the telemedicine interaction (e.g., health care practitioners consulting with one another), in an emergency situation when a patient is unable to give informed consent, and the patient is under the jurisdiction of the California Department of Corrections and Rehabilitation (CDCR) or any other correctional facility. 4)Establishes an informed consent procedure (specifically for telemedicine) that requires at least all of the following information be given to the patient or the patient's legal representative verbally and in writing: a) The patient or the patient's legal representative retains the option to withhold or withdraw consent at any time without affecting the right to future care or treatment or program benefits; b) A description of the potential risks, consequences, and benefits of telemedicine; c) All existing confidentiality protections apply; d) All existing laws regarding patient access to medical information and copies of medical information and copies of medical records apply; and, e) Prohibits dissemination of any patient identifiable images or information from the telemedicine interactions to researchers or other entities from occurring without consent. 5)Requires a patient or the patient's legal representative to AB 415 Page 4 sign a written statement prior to the delivery of health care via telemedicine, indicating that the patient or the patient's legal representative understands the written information provided pursuant to 4) above and that this information has been discussed with the health care practitioner, or his or her designee. 6)Makes the patient's written consent statement part of the patient's medical record. 7)Makes failure to comply with 3) to 6) above unprofessional conduct, but not a misdemeanor, as specified. 8)Establishes procedures for physicians to obtain verbal and/or written informed consent for specified treatments and procedures, such as hysterectomies, psychosurgery, electroconvulsive therapy, and assisted oocyte production. 9)Prohibits health plans and health insurers from requiring face-to-face contact between a health care provider and a patient for services appropriately provided through telemedicine, subject to all terms and conditions of the contract agreed upon between the enrollee or subscriber and the plan or insurer. Applies this prohibition to health plan contracts with the Medi-Cal Managed Care Program only to the extent telemedicine services are covered by and reimbursed under the Medi-Cal fee-for-service program, and Medi-Cal contracts with health plans are amended to add coverage of telemedicine services and make any appropriate capitation rate adjustments. 10)Prohibits health plans and health insurers from being required to pay for consultation provided by the health care provider by telephone or facsimile machines. 11)Defines, for the purposes of Medi-Cal, "teleophthalmology and teledermatology by store and forward" as transmission of medical information to be reviewed at a later time and at a distant site by a physician who is trained in ophthalmology or dermatology, where the physician at the distant site reviews the medical information without the patient being present in real time. 12)Prohibits, under the Confidentiality of Medical Information Act, licensed or certified health care professionals, clinics AB 415 Page 5 and health facilities, health plans, and contracting entities, as defined, from disclosing or using a patient's medical information for any purpose not necessary to provide health care services to the patient and related administrative functions, without first obtaining authorization from the patient or the patient's representative, as specified, with exceptions. EXISTING FEDERAL LAW : 1)Prohibits, under federal regulations implementing the federal Health Insurance Portability and Accountability Act, a health plan, health care clearinghouse or a health care provider, who transmits health information in electronic form (covered entity), from using or disclosing protected health information, for purposes other than medical treatment or payment, or health care operations, as defined, without written authorization of the patient, with exceptions. 2)Requires covered entities, and their business associates, to provide notice of medical privacy breaches involving the unauthorized acquisition, access, use, or disclosure of protected health information to each individual whose information has been subject to a breach within 60 days of the discovery of the breach. 3)Provides that if a law enforcement official determines that notice of a medical privacy breach would impede a criminal investigation or cause damage to national security, the notice shall be delayed, in a specified manner. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1)PURPOSE OF THIS BILL . According to the author, in 1996 California was the first state to pass legislation (the TDA) that, among other things, established telemedicine as a legitimate means of receiving health care services, and provided parameters for reimbursement in both private and public health coverage plans. When first passed in 1996, telemedicine was still an unknown entity to many. With almost two decades of experience utilizing telemedicine in California and nationwide, the Veteran's Administration has been one of AB 415 Page 6 the most prolific users of this mode of health care, some of the concerns in 1996 no longer apply. The provisions of the original TDA and its subsequent amendments are outdated and may inhibit the full adoption of telehealth in this state and the potential benefits such as reducing costs, increasing access and improving the quality of care it can offer. In 2010, the Center for Connected Health Policy (CCHP) convened a diverse work group of 25 prominent health care and policy professionals to participate in a Telehealth Model Statute Work Group. This group examined the barriers to the integration of telehealth as a tool into California's health care delivery system. A report that contained thirteen recommendations was issued in March 2011. This bill picks up some of the thirteen workgroup recommendations, and will clean up parts of current law that have provided barriers in adopting the advances and changes made in the last 15 years in addition to reducing the duplicative administrative work and barriers regarding telehealth. 2)TELEMEDICINE/TELEHEALTH . Telehealth services consist of diagnosis, treatment, assessment, monitoring, communications, and education. Telehealth includes telemedicine, which is the diagnosis and treatment of illness or injury. Telehealth medical services are delivered in three ways: video conferencing, which is used for real-time patient-provider consultations, provider-to-provider discussions, and language translation services; patient monitoring, in which electronic devices transmit patient health information to health care providers; and, store and forward technologies, which electronically transmit pre-recorded videos and digital images, such as X-rays, video clips, and photos, between primary care providers and medical specialists. 3)CCHP RECOMMENDATIONS . In February 2011, CCHP issued a report with 13 recommendations to update California's Telemedicine Development Act. The revisions to existing law that this bill contemplates are based on the following recommendations from the CCHP report: a) Update the term "telemedicine" used in current law to "telehealth," to reflect changes in technologies, settings, and applications for medical and other purposes; b) Include the asynchronous application of technologies in the definition of telehealth and remove the 2013 sunset AB 415 Page 7 date for Medi-Cal reimbursement of teledermatology, teleophthalmology, and teleoptometry services; c) Remove restrictions in the current telemedicine definition that prohibit telehealth-delivered services provided via email and telephone; d) Eliminate the current Medi-Cal requirement to document a barrier to an in-person visit for coverage of services provided using telehealth; e) Require private health care payers and Medi-Cal to cover encounters between licensed health practitioners and enrollees irrespective of the setting of the enrollee and providers; and, f) Remove the requirement necessitating an additional informed consent waiver be obtained prior to any telehealth services being rendered. According to the author, no changes have been made to the definition of telemedicine since the TDA was first enacted in 1996. The current law did not take into consideration technological advances and the changing health and policy landscape. Restrictions on email and phone do not reflect current practices by private payers who have utilized these options in order to deliver care in a more efficient and effective manner. The CCHP indicates that telehealth is a mode of providing services (not a treatment or procedure) but is treated similarly in California law as these highly invasive procedures. By eliminating the required written informed consent, more expedient choices are created for patients; a delay to obtain written consent can be avoided. 4)REIMBURSEMENT POLICIES . Public and private (CalPERS) programs reimburse for different aspects of Telemedicine services. Medicare and Medi-Cal offer reimbursement. According to a 2008 report by the California Telemedicine and eHealth Center, in California, Medi-Cal recognizes physician consultations (medical and mental health) when furnished using interactive video teleconferencing. Payment is on a fee-for-services basis, which is the same as the reimbursement for covered services furnished in the conventional face-to-face manner. Both consulting and referring providers can be reimbursed for Telemedicine at both the hub and spoke sites. Medi-Cal only covers store and forward for teledermatology, teleophthalmology and teleoptometry, which is set to sunset on January 1, 2013. According to the CCHP report, coverage for specific services vary by a payer, but a AB 415 Page 8 clearer more consistent policy context concerning the delivery of those services through telehealth should lead to increased provider reimbursement. 5)RELATED LEGISLATION . AB 386 (Galgiani), pending in the Assembly, requires CDCR to have an operational telemedicine services program at all adult institutions, as specified, by January 1, 2016. AB 386 was approved in the Assembly Committee on Health and referred to the Assembly Committee on Public Safety where amendments will be adopted to replace "telemedicine" with "telehealth." SB 946 (Committee on Health) incorporates some of the same terminology changes proposed in this bill and is pending in the Senate. 6)PREVIOUS LEGISLATION . a) AB 175 (Galgiani), Chapter 419, Statutes of 2010, for the purposes of Medi-Cal reimbursement, expands, until January 1, 2013, the definition of "teleophthalmology and teledermatology by store and forward" to include services of an optometrist who is trained to diagnose and treat eye diseases. b) AB 2120 (Galgiani), Chapter 260, Statutes of 2008, extends the Medi-Cal telemedicine reimbursement authorization until January 1, 2013. c) AB 329 (Nakanishi), Chapter 386, Statutes of 2007, authorizes MBC to establish a pilot program to expand the practice of telemedicine, and to convene a working group. AB 329 specifies that the purpose of the pilot program is to develop methods, using a telemedicine model, of delivering health care to those with chronic diseases and delivering other health information, and requires MBC to make recommendations regarding its findings to the Legislature within one calendar year of the commencement date of the pilot program. MBC reports that this pilot program is currently commencing. d) AB 1224 (Hernández), Chapter 507, Statutes of 2007, adds optometrists to the list of health care providers covered under laws governing telemedicine services. AB 415 Page 9 e) AB 354 expands telemedicine provisions by providing that, from July 1, 2006 through December 31, 2008, face-to-face contact between a health care provider and a patient shall not be required for the Medi-Cal program for "store and forward" teleophthalmology and teledermatology services. f) SB 1665 (Thompson), Chapter 864, Statutes of 1996, establishes TDA to set standards for the use of telemedicine by health care practitioners and insurers. TDA specifies, in part, that face-to-face contact between a health care provider and a patient shall not be required under the Medi-Cal Program for services appropriately provided through telemedicine, when those services are otherwise covered by the Medi-Cal program, and requires a health care practitioner to obtain verbal and written consent prior to providing services through telemedicine. 7)SUPPORT . The California State Rural Health Association states in support of this bill that telehealth and other health information technologies are critical tools for our rural healthcare safety net, increase health care access, quality, and cost-effectiveness of care in rural communities, especially for specialty care. Telehealth and other health information technologies can ensure that rural patients receive timely care that otherwise would be unavailable to them. Lack of adequate care increases the costs of rural health care and other economic costs in rural communities. Telehealth allows rural communities to care for patients in their home community rather than requiring them to travel to distant cities and it allows more health care dollars to be spent in the rural community where the patient's home is located. Telehealth and other advanced health information technology applications can alleviate chronic shortages of specialty care and increase the ability of rural communities to attract and retain health care providers. The Children's Partnership (TCP) supports this bill because low-income children living in medically underserved areas - both rural and parts of urban areas - face geographic and economic barriers to accessing health care. TCP states that telehealth helps overcome these barriers - such as health care provider shortages, transportation costs, and lost time from work and school - by using technology to bring the care to AB 415 Page 10 where the children are located. According to the University of California (UC), which supports this bill, there are three major initiatives underway to expand the use of telehealth technologies and expertise throughout the state. The first is the California Telehealth Network (CTN), a recent statewide broadband initiative to provide managed broadband access to hundreds of primarily rural health care facilities throughout California. The CTN expects to link more than 800 qualified sites, including the five UC academic health systems, Stanford University, University of Southern California, and Loma Linda University into a peer-to-peer network which will be one of the largest in the nation. A second enables the expansion of existing telemedicine programs at UC medical school campuses to provide facilities and state-of-the art equipment to expand telemedicine across the state. Lastly, the Specialty Care Safety Net Initiative is a collaborative effort between UC medical school specialty departments and safety net clinics in California. The initiative seeks to identify barriers to adoption and sustainability of telehealth programs in high-need specialties such as dermatology, endocrinology, hepatology, neurology, orthopedics and psychiatry. One proponent of this bill requested consideration for including telepsychiatry among the specialties where store and forward technology should be reimbursed without a sunset or expiration date. 8)OPPOSE UNLESS AMENDED . The Western Center on Law and Poverty (Western Center) opposes this bill unless it is amended to require informed consent of Medi-Cal enrollees who are about to receive health care services via telemedicine. Western Center doesn't oppose telemedicine or telehealth, but is concerned with the elimination of basic consumer protections in health care delivery. 9)DRAFTING CONCERNS . a) This bill is intended to assure reimbursement for telehealth services provided at a distant site (where a health care provider is located) while using a telecommunications system to deliver services to an originating site (where a patient is located or where asynchronous store and forward transfer occurs). This bill attempts to address this as follows: The (health care service plan/health insurer/DHCS) shall not limit the AB 415 Page 11 type of setting where services are provided for the patient or by the health care provider. As constructed, these provisions could be interpreted to apply more broadly than is intended. The author may wish to clarify these provisions to apply only in situations where telehealth services are provided subject to the terms and conditions of the contract between the enrollee or subscriber and the health care service plan. b) This bill should clarify that telehealth is covered by health care service plans, health insurers, and DHCS when appropriately provided at the discretion of the health care provider. 10)TECHNICAL AMENDMENTS . a) Page 8, lines 1-3 should be revised as follows: (e)The requirements of this subdivision shall also be operative for health care service plan contracts with the department pursuant to Article 2.7 (commencing with Section 14087.3), Article 2.8 (commencing with Section 14087.5), Article 2.81 (commencing with Section 14087.96), Article 2.91(commencing with Section 14089), or Chapter 8(commencing with Section 14200)Medi-Cal managed care program.REGISTERED SUPPORT / OPPOSITION : Support California State Rural Health Association (sponsor) AgeTech California California Association of Physician Groups California Center for Rural Policy at Humboldt State University California Medical Association Kings View Corporation Rural Health Sciences Institute in northern California The Children's Partnership University of California Opposition None on file. AB 415 Page 12 Analysis Prepared by : Teri Boughton / HEALTH / (916) 319-2097