Several important pieces of federal telemedicine legislation, introduced in the past 12-18 months, could affect the way medicine and healthcare are practiced through online, virtual, and mobile means.
The American Telemedicine Association tracks federal legislative initiatives in the telemedicine and telehealth industry. Recent ones include:
H.R. 6719 TeleHealth Promotion Act: To promote and expand the application of telehealth under Medicare and other Federal health care programs….and for other purposes. Provisions of this bill including: removing arbitrary restrictions on telehealth from federal care programs; and improving Medicare’s hospital readmission reductions program by including telehealth and remote patient monitoring services.
The removal of limitations on telemedicine has a parity provision, as follows:
An item or service under part A or part B of title XVIII furnished to a Medicare beneficiary by an individual or entity via a telecommunications system shall be covered to the same extent the item or service would be covered if furnished in the same location of the beneficiary, and benefits shall not be denied under either such part solely on the basis that the item or service is being furnished via a telecommunications system.
H.R. 3077 TELE-MED (TELEmedicne for MEDicare) Act of 2013: Amends title XVIII (Medicare) of the Social Security Act to permit certain Medicare providers licensed in a state to provide telemedicine services to Medicare beneficiaries in a different state. Strikingly, this bill purports to remove state licensing requirements that have hampered broader efforts to provide telemedicine:
In the case of a Medicare participating physician or practitioner who is licensed or otherwise legally authorized to provide a health care service in a State, such physician or practitioner may provide such a service as a telemedicine service to a Medicare beneficiary who is in a different State, and any requirement that such physician or practitioner obtain a comparable license or other comparable legal authorization from such different State with respect to the provision of such health care service by such physician or practitioner to such beneficiary shall not apply.
Absent such language, the physician or other licensed health care practitioner would normally have to be licensed in both their home state and the state where the patient is located. (See Telemedicine laws vary by state and Telemedicine issues addressed by regulation, as well as our Telemedicine and E-Health page). Note that the broad legal authorization for telemedicine in this bill only applies in the case of Medicare participating provider or practitioner who is providing a service to a Medicare beneficiary.
The bill requires the Secretary of the U.S. Department of Health & Human Services to “issue guidance to the States for developing a definition of the term telemedicine services for purposes of applying this section.”
The term Medicare participating physician or practitioner is as defined in the Medicare laws, namely: (A) A physician (as defined in section 1861(r)) who is a participating physician or supplier (as defined in section 1842(h)(1)). (B) A practitioner (as defined in section 1842(b)(18)(C)) who is a participating physician or supplier (as defined in section 1842(h)(1)).
H.R. 3306 Telehealth Enhancement Act of 2013: Among other things –
- Authorizes an Accountable Care Organization (ACO) to include coverage of telehealth and remote patient monitoring services as supplemental health care benefits to the same extent as a Medicare Advantage plan is permitted to provide such coverage of such services as supplemental health care.
- Recognizes telehealth services and remote patient monitoring in the national pilot program on payment bundling.
- Includes among originating sites (at which an eligible telehealth individual is located at the time a service is furnished via a telecommunications system), but without receiving payment of a facility fee, any critical access hospitals, sole community hospitals, home telehealth sites, as well as specified others.
- Amends SSA title XIX (Medicaid) to give states the option to provide coordinated care for enrollees with high-risk pregnancies and births.
- Amends the Communications Act of 1934 to specify additional health care providers to which universal telecommunications service support must be provided.
- Requires Federal Communications Commission (FCC) rules for enhancing health care provider access to advanced telecommunications and information services to disregard provider location.
While the federal government contemplates additional legislation to increase telemedicine options for patients, telemonitoring is also increasing across state lines as well as intrastate. While telemedicine involves physician-patient conversations, telemonitoring involves remote collection of vital patient data, without necessarily requiring that the physician and patient interact directly.
Telemedicine, telehealth, telepsychology, telecounseling, e-health, mobile health, mobile apps, and online healthcare are exploding.
State licensing laws applicable to telemedicine are only one set of legal rules that could apply. Additional concerns include:
- Confidentiality, privacy, HIPAA, and cybersecurity
- Liability concerns including standard of care, vicarious as well as direct liability
- Informed consent rules tailored to online and mobile health
- FDA medical device concerns (for example, in the case of mobile medical apps, or any instrument intended to diagnose or treat disease)
- Compliance with other healthcare regulatory requirements
- self-referral and anti-kickback legal issues
When creating a telehealth venture, it’s important to contact experienced legal counsel to help structure the enterprise so as to minimize and manage legal and regulatory risks. Healthcare is pushing the boundaries of the Matrix, but legal rules still define how the organism can grow.