Page 32 - Mar2019_BarJournal

BarJournal HEALTH CARE LAW

JULY/AUGUST 2015
fEaTUrE Considerations In

Telemedicine Contracting

BY DAVID E. SCHWEIGHOEFER

he use of remote-based technology meets one of the exceptions listed in Paragraph § 411.357(p); and (viii) electronic health records
in the delivery of healthcare services D of the rule, then the answer is “yes”). items and services (42 C.F.R. § 411.357(w)).
has grown dramatically in recent You may wish to visit the Ohio State Medical It is always advisable when considering a
years. Of interest to providers is Board website to review their position statement potential arrangement under the Stark Law
Tthe expansion of telemedicine as a on telemedicine, and their recently released FAQs. whether a financial relationship exists, either direct
delivery method. This is due in part to the growing or indirect, between a physician (or immediate
provider shortage, rising healthcare costs, increased Fraud and Abuse Issues family member of a physician) in a position to
focus on accessibility, and payments based on Healthcare attorneys should review relevant refer patients to an entity for the provision of DHS
quality rather than quantity. As interest in these facts in any telemedicine arrangement to ensure payable by Medicare or Medicaid.
remote-based delivery models becomes more compliance with relevant fraud and abuse Additionally, review the relevant portions of
prevalent in the universe of providers, and as statutes, exceptions and safe harbors. Under the Civil Monetary Penalties Law, restrictions
consumers become more familiar and comfortable the Federal Anti-Kickback Statute (42 U.S.C. on beneficiary inducement, the preventative
with the use of this technology, healthcare § 1320a-7b(b)) the most common safe harbors care exceptions, financial need exceptions, and
attorneys are increasingly involved in crafting utilized in telehealth arrangements involve (i) promoting access to care exceptions. And as always,
such arrangements. Accordingly, it may be helpful space rental; (ii) equipment rental; (iii) personal don’t be remiss in reviewing Ohio specific statutes
to develop a checklist of considerations to serve services and management contracts; (iv) the in these areas.
as guideposts as you construct the arrangements. bona fide employment safe harbor; and (v) the The OIG has issued several Advisory Opinions
managed care safe harbor. on various telehealth arrangements, and these too
The Rules When constructing a telehealth arrangement, are useful in evaluating compliance (see: AO 98-18;
As the provision of telemedicine services has consider: AO 99-14; and AO 11-12).
grown in terms of categories of providers, sites • Whether the arrangement can be constructed
of service, and institutional definitions, so has the to satisfy the applicable safe harbor; Consent
regulatory framework grown. Ohio has several • If the parties are potential referral sources Securing patient consent is an important aspect
relevant Revised Code and Administrative Code to one another; of the delivery model. Often providers do not
rules that are worthy of review prior to proceeding • Is remuneration moving from one party to realize that a general consent to treatment is
(see ORC 4731.296 regarding the telemedicine another; not sufficient for telemedicine services. An
certificate; new rules on prescribing to patients not • Are the services reimbursable by a federal excellent guide to state-level requirements for
seen by the physician, OAC 4731-11-09; and OAC health care program; consent to telemedicine is to check The National
7331-11-09 for definitions). • How the marketing costs of the service are Telehealth Policy Resource Center’s state map.
As one might expect, the rules have many allocated; and When assisting a provider in drafting a compliant
nuances that may be relevant to your client • Will the parties refer patients for other consent policy, best practices include:
arrangement. A few examples: services. • Informing patients of their rights when receiving
• OAC 4730-1-06 states that all rules in chapter Telehealth arrangements between a physician telemedicine, including the right to stop or refuse
4731-11 are applicable to physician assistants. (or immediate family member of a physician) treatment;
See ORC 4730.42 so that your supervising and a DHS entity to which that physician refers • Informing patients of their individual
physician does not grant physician-delegated for DHS payable by Medicare must be carefully responsibilities when receiving telemedicine
authority to a physician assistant in a manner examined to ensure that an exception to the treatment; and
exceeding the supervising physician’s Stark Law (42 U.S.C. §§1395nn, et seq.) applies. • Establish a formal complaint or grievance
prescriptive authority. Commonly used exceptions are: (i) rental of procedure process to resolve any potential
• Is there a difference between prescribing office space (42 C.F.R § 411.357(a); (ii) rental equipment failure during telemedicine sessions
controlled medications versus non-controlled of equipment (42 C.F.R. § 411.357(b); (iii) and include a contingency plan.
medication to a patient under Rule 4731-11- bona fide employment relationships (42 C.F.R. See hub.americantelemed.org/thesource/resources/
09? (hint: yes) § 411.357(c); (iv) personal service arrangements telemedicine-forms for examples of well-written
• Can a psychiatrist prescribe Schedule II (42 C.F.R.§ 411.357(d)(1); (v) fair market value consent and authorization forms.
controlled stimulants to a patient who is remote compensation (42 C.F.R. § 411.357(l); (vi) pre- Attorneys may wish to guide clients to review
and who has not had an in-person examination? paid plan exception (42 C.F.R. § 411.355(c); (vii) and utilize pre-existing platforms for telemedicine
(in general, no, unless the prescribing situation indirect compensation arrangements (42 C.F.R software. Doxey.me is one such platform. It is
32 | Cleveland Metropolitan Bar Journal clemetrobar.org