Iowa Board of Medicine

Iowa Supreme Court says portions of the Iowa Board of Medicine’s rule, not consistent with standards of medical practice, place an unconstitutional burden on a woman’s exercise of her constitutional rights to an abortion.

Planned Parenthood of the Heartland v. Iowa Board of Medicine, No. 14-1415, filed June 19, 2015

The Iowa Supreme Court, on a 6-0 vote, invalidated as unconstitutional those portions of the IBM’s telemedicine medication abortion rule prohibiting physicians from inducing an abortion by providing an abortion-inducing drug without first providing a physical examination of the woman, without being physically present with the woman at the time of abortion-inducing drug is provided, and without scheduling a follow-up appointment with the woman at the same facility where the abortion-inducing drug was provided. In that case, Planned Parenthood of the Heartland v. Iowa Board of Medicine, portions of the IBM rule defining “abortion-inducing drug” and requiring compliance with Iowa’s law on parental notification prior to performing an abortion on a minor were not challenged on appeal and, as such, the Court affirmed them.

The Court looked to the IBM’s stated purposes for adopting its medication abortion rule (found at Iowa Administrative Code (IAC) 653-13.10 but put on hold by the Court pending the outcome of this appeal). The IBM particularly emphasized the need to protect the health and safety of women seeking a drug-induced, or medication, abortion. The Court engaged in extensive discussion of each patient health and safety interest asserted by the IBM for its rule. In doing so, the Court also looked to the IBM’s more recently adopted general standards for telemedicine practice in Iowa (IAC 653-13.11, a rule now in effect and not affected by this decision). The Court noted that physicians are required by the IBM’s general telemedicine rule to “utilize evidence-based telemedicine practice guidelines and standards of practice, to the degree they are available, to ensure patient safety, quality of care, and positive outcomes” and to perform “a physical examination, when medically necessary, sufficient for the diagnosis and treatment of the patient.”

In examining standards of medical practice for medication-induced abortions, the Court looked to practice standards of the American College of Obstetricians and Gynecologists (ACOG) which provide that a physical examination by the physician prior to proceeding with a medication termination of pregnancy is not medically necessary. Rather, ACOG says, the medical information necessary to performing a medication abortion is contained in the patient’s history, blood work, vital signs, and ultrasound images which can be accessed by reviewing the patient’s records remotely or in person. The Court also found that the weight of the evidence indicates that a pelvic examination prior to administering the abortion-inducing medication does not provide any measurable gain in patient safety. The Court further looked to FDA protocol for administration of mifepristone and misoprostol to induce an abortion, noting that FDA approved protocol does not prohibit physicians from using drugs in a different, “off-label,” manner; that additional studies have led to the development of safer and more effective administration protocol; and it is that newer protocol the IBM’s rule is meant to preclude.

The Court found little medical practice or drug regulatory support for the IBM’s asserted interests in adopting its medication abortion rule but substantial challenges for a woman seeking an abortion under the rule’s physician examination and in-person requirements. “It is not disputed the rule would have the effect of prohibiting telemedicine abortions in Iowa.” In balancing the IBM’s purposes in adopting the rule, which are not supported by the medical record, in light of the burdens the rule places upon a woman seeking to exercise her constitutional rights, the resultant consequences for the woman unconstitutionally outweigh the IBM’s asserted interests.

“Most significantly,” the Court went on to say, “the Board has adopted a rule that generally approves the use of telemedicine.” Yet, in its medication abortion rule, “the Board appears to hold abortion to a different medical standard than other procedures.” As such, the Court also hinted at constitutional equal protection issues.

The IBM issued a release on June 19, the same day the Court filed its opinion, noting the Court’s decision and stating that the IBM would discuss ruling at its July 9-10, 2015 meeting.

Licensing Boards with a majority of members actively practicing in the regulated profession are vulnerable under the antitrust laws.

North Carolina State Board of Dental Examiners v. Federal Trade Commission, U.S. Supreme Court No. 13-534 (decided February 25, 2015).

Iowa health professional licensing boards, by law, are comprised of a majority of actively practicing licensed members of their professions appointed by the governor and approved by the Senate. For instance, the Iowa Board of Medicine (IBM) has 10 members, seven (7) of whom must be licensed physicians active in medical practice in this state. The Iowa General Assembly has determined that the expertise of licensed and practicing professionals is critical to informed board decision-making in setting parameters of practice, establishing qualifications for licensure, and determining appropriate grounds for licensee discipline.

Professional licensing boards in Iowa also are agencies of state government. They must exercise their authority and meet their responsibilities consistent with processes and procedures and powers and duties set forth in laws passed by the General Assembly. The legislature grants authority to licensing boards to assure that only appropriately educated, trained and qualified individuals practice in the profession. Periodically, licensing boards like the IBM issue cease and desist orders against persons for unlawfully practicing in the profession absent medical licensure.

A recent case decided by the U.S. Supreme Court examined enforcement actions of a state licensing board for the unlicensed practice of the profession under the microscope of the federal antitrust laws. In North Carolina State Board of Dental Examiners v. FTC, the Court examined the extent to which professional licensing boards enjoy “state action” immunity from federal antitrust liability. The case centered on alleged anticompetitive behaviors of the North Carolina Dental Board against non-licensed providers of teeth whitening services and products.

Dentists had been providing teeth whitening services in North Carolina since the 1990s. Starting in 2003, however, non-licensees began offering these services at prices substantially lower than those charged by dentists. The Dental Board received complaints from its licensees, most of which focused on the lower charges and not on harmful impacts to the public. The Board investigated and then, without adopting a rule, took aggressive action through cease and desist letters issued to non-dentist teeth whitening service providers and product manufactures; letters to shopping malls advising them that kiosk providers of teeth whitening services were in violation of the practice of dentistry; and warnings it convinced the cosmetology licensing board to send its licensees against teeth whitening practice. As a result of the Board’s actions, non-dentists ceased offering teeth whitening services in North Carolina.

The Dental Board is an agency of its state government with eight members, six of whom are actively practicing licensed dentists; one is a licensed dental hygienist; and one is a public member. Members of the dental profession elect the dentist members; dental hygienists elect the dental hygienist member; and the governor appoints the pubic member. Eight of the ten dentists who were members of the Board during the time of this dispute earned substantial fees from teeth whitening services.

In 2010, the Federal Trade Commission (FTC), a federal antitrust enforcement agency, filed an administrative complaint against the Dental Board. After motions and hearings, the FTC concluded that the Dental Board’s enforcement actions against teeth whitening competitors had unreasonably restrained trade in violation of the antitrust laws. The FTC rejected the Board’s public safety justification, saying that a wealth of evidence suggested that tooth whitening by non-dentists is a safe cosmetic procedure. The FTC also rejected the Board’s claims that as an agency of the state, it had state action immunity from federal antitrust liability.

The Board challenged the FTC’s decision in federal court. The 4th Circuit Court of Appeals, however, found in favor of the FTC. The Board then took its case to the U.S. Supreme Court.

A significant fact permeating the Supreme Court’s analysis of state action antitrust immunity for this licensing board was its composition. A majority of member decision makers from among the regulated dental profession created the potential for concerted action against competitors. It seemed to make no difference to the Court that the Dental Board members were elected by other dentists rather than appointed by the governor with approval authority from the legislature, as is the case in Iowa.

The Court explained two ways in which state action immunity from federal antitrust enforcement may attach. The first is immunity afforded to anticompetitive conduct by states acting in a sovereign capacity. In its 1943 case, Parker v. Brown, the Supreme Court explained that state action immunity from antitrust liability is accorded to states without need for further proof so long as the challenged activity is an exercise of the State’s “sovereign” power, such as legislation passed by a state general assembly or decisions entered by a state supreme court. “[T]he Sherman Act confers immunity on the State’s own anticompetitive polices out of respect for federalism.”

The Dental Board argued that as an agency of state government, it could claim Parker state action immunity without need for further proof. The Supreme Court disagreed. “State agencies are not simply by their governmental character sovereign actors for purposes of state-action immunity.” State action immunity for state agencies, the Court said, requires more to ensure that the State sovereign accepts political accountability for the agency’s challenged anticompetitive behavior.

The Court then turned to the second path for claiming state action immunity from federal antitrust liability. A non-sovereign entity, to claim state action protection, must meet a two-part test established by the Supreme Court in its 1980 case, California Retail Liquor Dealers Assn. v. Midcal Aluminum Assoc. The Midcal test requires a non-sovereign actor to prove that 1) the challenged restraint is a clearly articulated and affirmatively expressed state policy which 2) is actively supervised by the State. Successfully meeting this two-pronged test solidifies that the State, in its sovereign capacity, has accepted political accountability for the anticompetitive conduct, thereby justifying state action immunity from antitrust liability for the non-sovereign’s challenged activity.

The Court moved from speaking generally about agencies of state government to focus particularly on those non-sovereign government actors, like the Dental Board, comprised of a majority of active market participants from within the profession. “Limits on state-action immunity are most essential when the State seeks to delegate its regulatory power to active market participants, for established ethical standards may blend with private anticompetitive motives in a way difficult even for market participants to discern.” To claim state action immunity, then, the Dental Board was required to meet the two-pronged Midcal test, thereby showing that it did not act on its own but, rather, was clearly and affirmatively carrying out state policy and, in doing so, was actively supervised by the State.

The FTC did not make an issue of whether the Board’s cease and desist actions against non-licensee teeth whitening providers met the first Midcal test so the Court moved to the second, “active state supervision,” prong. The Dental Board, however, never argued that its cease and desist actions were actively supervised by the State; instead, it unsuccessfully relied on Parker immunity. As such, the Court had no facts to analyze on this point. Even so, it noted that the North Carolina legislature had not defined teeth whitening as a practice requiring a dental license nor had the Board used “any of the powers at its disposal that would invoke oversight by a politically accountable official.”

The Court’s final holding or ruling was narrowly focused: “The Court holds today that a state board on which a controlling number of decisionmakers are active market participants in the occupation the board regulates must satisfy Midcal’s active supervision requirements in order to invoke state-action antitrust immunity.” Whether the test is met depends upon the circumstances of each case. While day-to-day involvement of the State in the agency’s challenged action is not required, “active supervision” calls for State review of the substance of the board’s anticompetitive decision, along with the power to veto or modify that decision.

In addressing the uncomfortable facts in this case, the Court issued a ruling of significant implication for all professional licensing boards. Whether this decision will deter qualified professionals from serving on state licensing boards for fear of antitrust liability remains to be seen. More importantly, however, may be the extent to which licensing boards with majority membership and essential expertise from active participants in the regulated profession will be chilled by this decision in making tough enforcement judgment calls on non-licensee practice of the profession.

The Court gave some counsel. If a licensing board’s enforcement action is supported by specific state law directing what otherwise might be viewed as anticompetitive activity, the board likely meets the Midcal test. Yet, it is not realistic to expect a state legislature to define with specificity all acts that fall within the scope of a regulated profession; indeed, that is one of the functions delegated by the Iowa General Assembly to its licensing boards. Rulemaking, the Court seems to hint, also may provide effective support for licensing board immunity from antitrust challenge under the Midcal test. In Iowa, a licensing board’s proposed rule is subject to review by the Iowa Administrative Rules Review Committee, composed entirely of lawmakers from both the House and the Senate and with authority to delay a rule and refer it to the General Assembly for its review and action.

The behavioral checks imposed by the Supreme Court make sense under the bothersome facts of this case. A strident reading of Midcal by regulators and courts in future licensing board cases, however, risks shifting the pendulum of free market health care practice too far away from the critical role professional licensure plays in assuring quality, competent and safe medical care. In that regard, the consumer the antitrust laws seek to protect is not well served.

The Iowa Board of Medicine (IBM), at its April 3, 2015 meeting, approved a final rule setting forth disciplinary standards applicable to physicians who use telemedicine in diagnosing and treating patients located in Iowa.

That rule also includes standards and prohibitions that all physician licensees must comply with in providing patient care whether by telemedicine or not. The adopted Rule will be published in the April 29 Iowa Administrative Bulletin and then reviewed by the legislature’s Administrative Rules Review Committee at a time yet to be set. The rule is slated to go into effect on June 3, 2015.

The IBM, in the final rule, made several changes to its proposed telemedicine practice rule.  Those changes reflect the IBM’s responses to public comments on its originally noticed proposed rule and its next draft.  Changes, for the most part, bring clarity to the rules and their expectations.

The final rule primarily addresses requirements for physicians who use telemedicine. Those requirements are substantial. Failure to satisfy any of these requirements subject the physician using telemedicine to IBM discipline. Failure to comply with the rules also might be claimed by plaintiffs alleging medical negligence in the delivery of telemedical care.

It is critical that physicians using telemedicine understand the IBM’s substantial expectations of them. The fact that a hospital or other telemedicine site ordinarily is operationally responsible for certain of the IBM’s proposed requirements (i.e., equipment compliance with safety codes, HIPAA privacy and security compliance), standing alone, does not relieve the telemedicine physician from assuring compliance with such requirements as set forth in the IBM’s telemedicine rule. The final rule made changes to reflect this concern, yet physicians continue to face discipline for non-compliance on each of the final rule requirements.

The following is a summary of the IBM’s final rule. Click here to read the final rule.

The IBM defines telemedicine by clarifying what telemedicine means and includes as well what it does not include for purposes of this rule.

  • Telemedicine means the practice of medicine using electronic audio-visual communications and information technologies or other means, including interactive audio with asynchronous store and forward transmission, between a physician licensee in one location and a patient in another location with our without an intervening health care provider. Telemedicine includes store-and-forward technologies, remote monitoring, and real-time interactive services, including tele-radiology and tele-pathology.
  • Telemedicine does not include the provision of medical services only through an audio-only telephone, email messages, facsimile transmissions, mail service, or any combination thereof.

For physicians using telemedicine, the rule makes it clear that –

  • Physicians using telemedicine will be held to the same standards of care and professional ethics as physicians using traditional in-person encounters with patients.
  • Physicians using telemedicine must do so within the physician’s scope of practice and the physician’s education, training, experience, ability, and licensure/certification.
  • Physicians using telemedicine in the diagnosis and treatment of a person located in Iowa must have an active Iowa medical license consistent with federal and state law (unless an exception to licensure already provided in the IBM’s licensure rules applies) regardless of the in-state or out-of-state site from which the physician provides those telemedicine services.
  • Physicians using telemedicine must utilize evidence-based telemedicine practice guidelines and standards of practice to the degree they are available.

Physicians using telemedicine must establish a valid physician-patient relationship with the person who receives telemedicine services. For purposes of this rule —

  • The physician-patient relationship begins when 1) a person with a health-related matter seeks assistance from a physician; 2) the physician agrees to undertake diagnosis and treatment of that person; and 3) the person agrees to be treated by the physician even if there has not yet been an in-person encounter between the physician and that person.
  • A valid physician-patient relationship may be established in one of three ways: 1) an in-person encounter with an in-person medical interview and physical exam where standards of care would require an in-person encounter; 2) consultation with another physician or other health care provider who has an established relationship with the patient and who agrees to participate in or supervise the patient’s care; or 3) a telemedicine encounter if standards of care do not require an in-person encounter and consistent with evidence-based telemedicine practice guidelines.
  • An “in-person encounter” is defined to mean the physician and the patient are in the physical presence of each other and in the same physical location during the physician-patient encounter.

Further, physicians using telemedicine must –

  • Ensure that systems are in place to ensure that non-physician health care providers whom the physician relies upon or delegates to in the provision of a telemedical service are qualified and trained to provide such service within the non-physician’s scope of licensed practice; further, the physician must be available either in-person or electronically to consult with non-physician health care providers, particularly in the event of an injury or an emergency in the course of telemedicine service delivery.
  • Verify the identity of the patient receiving the telemedicine services and ensure the patient can verify the identity, licensure status, certification and credentials of all health care providers involved in providing the telemedical service prior to the provision of that care.
  • Ensure the patient is interviewed to collect the patient’s relevant medical history, receives a physical examination when medically necessary, sufficient for diagnosis and treatment prior to providing treatment via telemedicine, including issuing a prescription electronically or otherwise. The medical interview and physical examination need not be in-person if the telemedical encounter is sufficient to establish an informed diagnosis as though the medical interview and physical exam had been performed in-person.  A static Internet questionnaire alone cannot suffice for the medical interview and physical exam prior to treatment, including issuing a prescription either electronically or otherwise.  “Static” is defined in the rule.
  • Ensure that patient informed consent is provided, including consent for the use of telemedicine, and that such consent is timely documented in the patient’s medical record.
  • Identify and provide the patient’s medical record to the patient’s treating physician and/or medical home, when available and medically appropriate, where in-person medical services can be delivered in coordination with the telemedicine services the patient receives.
  • Have access to or adequate knowledge of local medical resources for appropriate follow-up care.
  • Refer a patient receiving telemedical services to an acute care facility or emergency department in the event of an emergency or for the safety of the patient.
  • Ensure complete, accurate, and timely medical records, as appropriate, including notation of when telemedicine is used and other matters set forth in the rule, and, further, ensure that the patient and other health care providers have timely access to such information and that the patient, upon request, receives a timely summary of each telemedical encounter.
  • Ensure that all telemedicine encounters comply with HIPAA privacy and security measures.  Written protocol must be established and periodically reviewed, addressing measures specified by the IBM in its proposed rule to assure the confidentiality and integrity of patient-identifiable information.
  • Equipment and technology used in the telemedical encounter must comply with safety laws and codes and are of sufficient quality/size/resolution/clarity to safely and effectively provide the telemedicine service.
  • Ensure that information is disclosed to the patient re: the type of services to be provided via telemedicine; contact information, identity and credentials of all health care providers involved in the provision of the telemedical service; limitations, if any, on drugs and services as provided via telemedicine; fees/costs sharing if different than in an in-person encounter; financial interests, if any; limitations on the use of the telemedicine technology; and other information as detailed in the proposed rule.
  • Ensure the patient’s ability to amend their patient information, to provide feedback on the quality of the telemedical encounter, and to register complaints.

For all physicians, whether in the course of using telemedicine or otherwise, the final rule –

  • Sets forth several circumstances under which standards of medical care may not require a physician licensee to personally examine a patient. Circumstances include where the physician prescribes medications on a short-term basis for a new patient and has scheduled or is in the process of scheduling an appointment to personal examine the patient; call or cross-coverage situations in which a physician licensee is taking call or is covering for the other physician licensee who has an established physician-patient relationship with the patient; situations in which the patient has been examined in person by an advanced registered nurse practitioner or physician assistant or other licensed practitioner with whom the physician licensee has a supervisory or collaborative relationship; and other circumstances set forth in the rule.
  • Prohibits physician licensees from prescribing based solely on an Internet request or an Internet questionnaire. An internet questionnaire is defined to mean a static questionnaire provided to a patient to which the patient responds with a static set of answers, in contrast to an adaptive, interactive and responsive online interview.
  • Prohibits physician licensees from prescribing based solely on a telephonic evaluation for any person absent a valid physician-patient relationship.

See our page dedicated to Telemedicine for all related articles.

UPDATE: Subsequent to this post the IBM has adopted the Telemedicine Rule. See our page dedicated to Telemedicine for all related articles, including our most current post.

The Iowa Board of Medicine Amends Its Proposed Telemedicine Rule – Final Adoption Slated for the IBM’s April 3 Pubic Meeting

The Iowa Board of Medicine (IBM) has made several changes to its proposed disciplinary rule for physicians using telemedicine in Iowa. Those changes reflect the IBM’s responses to public comments on its originally noticed proposed rule. The IBM will accept comments on its amendments but no public hearing or comment period has been scheduled nor is the IBM required to do so.  The IBM expects to adopt a final telemedicine practice rule at its April 3, 2015, public meeting. The rule’s effective date, once adopted, will be set in the final rule.

While there are provisions in this proposed rule that apply to all physicians, for the most part the rule as amended remains focused on standards of practice for physicians who use telemedicine. The requirements of the rule are substantial. Failure to satisfy any of these requirements subject the physician using telemedicine to IBM discipline. Failure to comply with the rules also might be claimed by plaintiffs alleging medical negligence in the delivery of telemedical care.

It is critical that physicians using telemedicine in diagnosing or treating a patient located in Iowa understand the IBM’s substantial expectations of them. The fact that a hospital or other telemedicine site ordinarily is operationally responsible for certain of the IBM’s proposed requirements (i.e., equipment compliance with safety codes, emergency protocols, HIPAA privacy and security compliance), standing alone, does not relieve the telemedicine physician from assuring compliance with such requirements as set forth in the IBM’s telemedicine rule.

The following summary addresses the IBM’s proposed telemedicine disciplinary rule as now amended. Click here to read the amended proposed rule. The IBM has invited feedback on the draft amendments so further changes are possible prior to the IBM’s April 3 vote on adoption of the rule.

The IBM’s definition of telemedicine was amended to clarify what telemedicine means and includes as well as to affirm what it does not include for purposes of this rule.

• Telemedicine means the practice of medicine using electronic audio-visual communications and information technologies or other means, including interactive audio with asynchronous store and forward transmission, between a physician licensee in one location and a patient in another location with our without an intervening health care provider. Telemedicine includes store-and-forward technologies, remote monitoring, and real-time interactive services, including tele-radiology and tele-pathology.

• Telemedicine does not include the provision of medical services only through an audio-only telephone, email messages, facsimile transmissions, mail service, or any combination thereof.

For physicians using telemedicine, the proposed rule makes it clear that –

• Physicians using telemedicine will be held to the same standards of care and professional ethics as physicians using traditional in-person encounters with patients.

• Physicians using telemedicine must do so within the physician’s scope of practice and the physician’s education, training, experience, ability, and licensure/certification.

• Physicians using telemedicine in the diagnosis and treatment of a person located in Iowa must have an active Iowa medical license consistent with federal and state law (unless an exception to licensure already provided in the IBM’s licensure rules applies) regardless of the in-state or out-of-state site from which the physician provides those telemedicine services.

• Physicians using telemedicine must utilize evidence-based telemedicine practice guidelines and standards of practice to the degree they are available.

For physicians using telemedicine, the amended proposed rule requires a valid-physician patient relationship with the person who receives telemedicine services. For purposes of this rule —

• The physician-patient relationship begins when 1) a person with a health-related matter seeks assistance from a physician; 2) the physician agrees to undertake diagnosis and treatment of that person; and 3) the person agrees to be treated by the physician even if there has not yet been an in-person encounter between the physician and that person.

• A valid physician-patient relationship is established in one of three ways: 1) an in-person encounter with an in-person medical interview and physical exam where standards of care would require an in-person encounter; 2) consultation with another physician or other health care provider who has an established relationship with the patient and who agrees to participate in or supervise the patient’s care; or 3) a telemedicine encounter if standards of care do not require an in-person encounter and consistent with evidence-based telemedicine practice guidelines.

• An in-person encounter means the physician and the patient are in the physical presence of each other and in the same physical location during the physician-patient encounter.

Further, physicians using telemedicine must –

• Ensure that systems are in place to ensure that non-physician health care providers whom the physician relies upon or delegates to in the provision of a telemedical service are qualified and trained to provide such service within the non-physician’s scope of licensed practice; further, the physician must be available electronically to consult with non-physician health care providers, particularly in the event of an injury or an emergency in the course of telemedicine service delivery.

• Verify the identity of the patient receiving the telemedicine services and ensure the patient can verify the identity, licensure status, certification and credentials of all health care providers involved in providing the telemedical service prior to the provision of that care.

• Ensure the patient is interviewed to collect the patient’s relevant medical history receives a physical examination, when medically necessary, sufficient for diagnosis and treatment prior to providing treatment via telemedicine, including issuing a prescription electronically or otherwise. The medical interview and physical examination need not be in-person if the telemedical encounter is sufficient to establish an informed diagnosis on par with an in-person medical interview and physical exam. An Internet questionnaire alone cannot suffice for the medical interview and physical exam prior to treatment, including issuing a prescription either electronically or otherwise.

• Ensure that patient informed consent is provided, including consent for the use of telemedicine, and that such consent is timely documented in the patient’s medical record.

• Identify and provide the patient’s medical record to the patient’s treating physician and/or medical home, when available and medically appropriate, where in-person medical services can be delivered in coordination with the telemedicine services the patient receives.

• Have access to or adequate knowledge of local medical resources for appropriate follow-up care.

• Establish written protocols for referral of a patient receiving telemedical services to an acute care facility or emergency department in the event of an emergency or for the safety of the patient.

• Ensure complete, accurate, and timely medical records, as appropriate, including notation of when telemedicine is used and other matters set forth in the rule, and, further, ensure that the patient and other health care providers have timely access to such information and that the patient, upon request, receives a timely summary of each telemedical encounter.

• Ensure that all telemedicine encounters comply with HIPAA privacy and security measures and, further, establish written protocols, which shall be periodically reviewed, addressing measures specified by the IBM in its proposed rule to assure the confidentiality and integrity of patient-identifiable information.

• Ensure that the equipment and technology used in the telemedical encounter comply with safety laws and codes and are of sufficient quality/size/resolution/clarity to safely and effectively provide the telemedicine service.

• Disclose clearly to the patient the type of services to be provided via telemedicine; contact information, identity and credentials of all health care providers involved in the provision of the telemedical service; limitations, if any, on drugs and services as provided via telemedicine; fees/costs sharing if different than in an in-person encounter; financial interests, if any; limitations on the use of the telemedicine technology; and other information as detailed in the proposed rule.

• Ensure the patient’s ability to amend their patient information, to provide feedback on the quality of the telemedical encounter, and to register complaints.

For all physicians, whether in the course of using telemedicine or otherwise, the proposed rule, as amended –

• Sets forth several circumstances under which standards of medical care may not require a physician licensee to personally examine a patient. Circumstances include where the physician prescribes medications on a short-term basis for a new patient and has scheduled or is in the process of scheduling an appointment to personal examine the patient; call or cross-coverage situations in which a physician licensee designated by the patient or other physician licensee is taking call or is covering for the other physician licensee who has an established physician-patient relationship with the patient; situations in which the patient has been examined in person by an advanced registered nurse practitioner or physician assistant or other licensed practitioner with whom the physician licensee has a supervisory or collaborative relationship; and other circumstances set forth in the rule.

• Prohibits physician licensees from prescribing based solely on an Internet request or an Internet questionnaire. An internet questionnaire is defined to mean a static questionnaire provided to a patient to which the patient responds with a static set of answers, in contrast to an adaptive, interactive and responsive online interview.

• Prohibits physician licensees from prescribing based solely on a telephonic evaluation for any person absent a valid physician-patient relationship.

Iowa Board of Medicine to adopt a final telemedicine disciplinary rule in April – House Energy and Commerce Committee considers legislation to expand Medicare recognition of telemedicine – IBM pursues Interstate Medical Licensure by Compact to, among other things, facilitate telemedicine practice in Iowa

The Iowa Board of Medicine (IBM) has reviewed public comments received on its proposed disciplinary rule for physicians using telemedicine in Iowa and, in light of those comments, has elected to make changes to those rules. Once drafting is complete, the IBM will post the rule as amended for public comment on the changes. The IBM intends to adopt a final rule at its April 2-3, 2015 meeting.

On the national front, the House Energy and Commerce Committee is looking at draft legislation that would expand upon current geographic and technological parameters for Medicare payment of telehealth services. Medicare now pays for a very limited number (75 service codes) of Part B medical services delivered via telecommunications and only if the system used is real-time interactive audio and video and only if the patient receiving the services is at an originating site located in a rural Health Professional Shortage Area (HPSA) either outside of a Metropolitan Statistical Area (MSA) or in a rural census tract or in a county outside of a MSA (unless a Medicare telemedicine demonstration project).  Originating sites in recognized geographic areas can be in the offices of a physician or other practitioner; a hospital or critical access hospital (CAH); a rural health clinic; a federally qualified health center (FQHC); a hospital/CAH-based renal dialysis center; a skilled nursing facility (SNF); or a community mental health center (CMHC). The following practitioners are recognized by Medicare as providers of telehealth services: physicians; nurse practitioners, nurse-midwives, clinical nurse specialists and CRNAs; physician assistants; clinical psychologists and clinical social workers (subject to limitations); and registered dieticians or nutrition professionals.

The “Advancing Telehealth Opportunities in Medicare” is one section (Section 4181) of the “21st Century Cures Act,” a 400-page bipartisan legislative proposal under discussion in the House. The telehealth portion directs HHS to develop a Medicare telehealth payment methodology that does not increase program costs and gives HHS authority under specified conditions to relax current geographic, site, and practitioner limitations for payment for telehealth services provided to Medicare beneficiaries.

The House Energy and Commerce Committee accepted testimony regarding this draft telehealth proposal in January with a goal of introducing legislation sometime in February. While commenters generally supported the draft’s intent, many suggested that the bill proposal did not go far enough to ease current geographic and site limitations and embrace a broader range of “store and forward” and other telecommunication technologies.

About compact medical licensure in Iowa

The IBM has introduced legislation into the General Assembly seeking authorization for Iowa’s participation in an interstate medical licensure system via compact. Compact medical licensure allows a physician licensed in a “home” state to become licensed in other compact signatory states via the compact process. Senate Study Bill 1019 and House Study Bill 20, companion bills to approve Iowa’s participation in the compact, are now under subcommittee review in their respective legislative chambers.

The design for interstate medical licensure by compact was developed by the Federation of State Medical Boards (FSMB); the IBM was a participant in that process. The compact licensure process is similar in many respects to expedited licensure currently provided for in IBM rules.

At least seven (7) states must pass legislation authorizing participation for the compact to effective. The FSMB reports that in addition to Iowa, ten (10) states have introduced compact legislation: Minnesota, Montana, Nebraska, Oklahoma, South Dakota, Texas, Utah, Vermont, West Virginia, and Wyoming.  An interstate medical licensure compact commission would administer the compact; each signatory state would have two (2) representatives on the commission. Actual licensure and discipline of physicians in compact states remains with the licensing boards.

Organizations in support of Iowa’s legislation include the Iowa Medical Society; the Iowa Hospital Association; the Iowa Academy of Family Physicians; the Iowa Chapter of the American Academy of Pediatrics; the Iowa Psychiatric Society; the Iowa Osteopathic Medical Association; and several health systems, including Unity Point, Mercy Network, Cedar Rapids PHO, Genesis Health System, and Gunderson Lutheran Health. The American Medical Association endorsed the compact in November. The draft federal “21st Century Cures” legislation discussed above includes a “Sense of Congress” provision encouraging compact medical licensure to facilitate multistate practice and the provision of telehealth services across state lines.

See our page dedicated to Telemedicine for all related articles.

Iowa Board of Medicine’s proposed telemedicine rule has been filed – hearing and public comments set for January 15

At its December meeting, the Iowa Board of Medicine (IBM) voted to formally file its proposed rule establishing standards of practice for physicians who use telemedicine. A public hearing on the proposed rule will be held on January 15, 2015, at 1:00 pm in the Wallace State Office Building Auditorium, 502 E. 9th St, Des Moines. Written comments are due by 4:30 pm on January 15, 2015. The text of the proposed rule, filed as ARC 1769C, is available from the IBM’s website at http://www.medicalboard.iowa.gov/iowa_code/proposed%20rules/ARC%201769C.html. That site also provides a means for submitting comments electronically and for reviewing all comments received by the IBM on the proposed rule. To read Brick Gentry’s web postings regarding the many requirements of the proposed rule, click on ­­­­this blog’s topic “Telemedicine.”

The October 24, 2014 posting (last in this series) addresses practical considerations for physicians using telemedicine, in meeting several of the proposed rule’s requirements as well as the proposed rule’s specific requirements re: financial interests, links to internet sites, prohibited relationships with preferred pharmacies, and prohibited internet transactions for prescribing controlled substances.

Requirements (standards) for physicians – practical considerations.

Proposed rule 653-13.11(10) – Informed consent

Proposed rule 653-13.11(11) – Coordination of care

Proposed rule 653-13.11(12) – Follow-up care

Proposed rule 653-13.11(14) – Medical records

Summary. Physicians using telemedicine must (1) obtain and document the patient’s informed consent including consent for the use of telemedicine; (2) identify the patient’s medical home and/or treating physician and provide them a copy of the medical record; (3) be knowledgeable of local resources for providing follow-up care and ensure the patient has access to appropriate follow-up care following a telemedicine encounter; and (4) ensure a complete, accurate, and timely medical record for the patient when appropriate and, further, ensure the patient and/or the physician designated by the patient has timely access to all information obtained during the telemedicine encounter, including timely providing the patient with a summary of each telemedicine encounter upon request.

Considerations. These matters are appropriate activities for physicians in managing a patient’s care. As regulatory standards, however, it is important to determine if and how the specific requirements of these provisions can be satisfied by the physician using telemedicine. AMA policy H-480-946 on “Coverage and Payment for Telemedicine” addresses each of these components as appropriate to telemedicine delivery without ascribing specific responsibility for them to the physician using telemedicine. Can a physician meet the obligations of these rules through protocol adopted by, for instance, a hospital offering telemedicine services? It is important to confirm that actual practices now in place would – or would not – satisfy these proposed standards before the Iowa Board of Medicine (IBM) adopts them. The physician using telemedicine will be held accountable for meeting each requirement.

Financial interests – links to internet sites – relationships with preferred pharmacies prohibited.

Proposed rule 653-13.11(19)

Summary. Advertising or promotion of goods or products from which a physician licensee receives direct remuneration, benefits, or incentives (other than fees for medical services) is prohibited.

A physician licensee should not benefit from internet links they provide to patients for purposes of general health information; when providing links, physicians should be aware of implied endorsements offered from such sites.

Physicians may not have preferred relationships with any pharmacy. Physician licensees shall not transmit prescriptions to a specific pharmacy or recommend a pharmacy in exchange for any type of consideration or benefit from the pharmacy.

Considerations. These prohibitions, filed by the IBM as part of its proposed telemedicine, are generally applicable to all physician licensees and are not addressed to “physicians who use telemedicine.” These prohibitions are taken directly from the Federation of State Medical Board’s “Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine,” adopted by the FSMB in April 2014. These policies, to become disciplinary rules if adopted by the IBM, are matters that stand on their own. The IBM might consider filing separate notice of rulemaking on these specific provisions to assure fair notice of and full discussion on their impact upon all licensees, not only licensees using telemedicine.

Prescribing controlled substances – prohibited internet transactions.

Proposed rule 653-13.11(21)

Summary. Prescribing controlled substances to a patient based solely on an internet request, internet questionnaire, or a telephonic evaluation is prohibited.

Considerations. All physician licensees are subject to this proposed regulatory prohibition. Too, specific issues directed to online medical services merit focused discussion of their own. This provision should be separately noticed by the IBM to allow fair notice and opportunity for comment. Internet-based diagnostic and treatment services for low-risk medical conditions are now being promoted and seemingly well received in other states.

This prohibition addresses only prescribing controlled substances. Is it permissible, then, to prescribe non-controlled medications based solely on an internet request, internet questionnaire, or telephonic evaluation? How does this provision relate to proposed rule 13.11(8) which generally states that an internet questionnaire alone does not constitute an acceptable medical interview and physical exam for providing treatment, including issuing prescriptions, electronically or otherwise?

This prohibition on physician licensees very well may be appropriate. However, a proposed rule prohibiting this practice may be better evaluated on its own merits and not within the context of this already detailed rulemaking applicable to physicians using telemedicine.

This article is the final posting in this series on the Iowa Board of Medicine’s proposed standards of medical practice for physicians using telemedicine. We hope our comments foster discussion and, as may be appropriate, alternative approaches for these proposed physician disciplinary standards.

Telemedicine offers tremendous potential for increased access by Iowans to a wide range of highly skilled medical care as well as a dynamic environment for enhanced care communication and medical education. Many entities share responsibility for safe, competent, high quality telemedicine delivery. All parties, regardless of their positions on the proposed rules, want telemedicine to work well in Iowa.

We acknowledge the critical role the IBM plays in helping to assure competent and safe telemedicine delivery of medical care. At the same time, physicians subject to regulatory disciplinary standards must know what is required of them; must be reasonably capable of meeting regulatory expectations; and must not be inappropriately impeded by complex or confusing regulatory directives in pursuing this legitimate form of patient care delivery. The IBM’s rule proposal provides an excellent forum for understanding, discussion and debate in this evolving arena of health care delivery.

See our page dedicated to Telemedicine for all related articles, including our most current post.

The October 23, 2014 post addresses the proposed rule’s requirement for disclosures and functionality of telemedicine services and other provisions of the proposed rule that may be less the responsibility of physicians who use telemedicine and more the responsibilities of entities that purchase, offer and maintain telemedicine equipment and services.

Disclosures and functionality of telemedicine services.

Proposed rule 653-13.11(17)

Summary. The physician using telemedicine must clearly disclose to the patient the types of services to be provided; contact information for the physician; identity, licensure, board-certification, credentials, and qualifications of all health care providers providing the telemedicine service; limitations on drugs and services that can be provided via telemedicine; fees and cost sharing responsibilities; financial interests; appropriate uses and limitations of the technologies; uses and response times for emails, electronic messages, and other communications transmitted via telemedicine; to whom patient information may be disclosed and for what purposes; rights of patients with respect to patient information; and information collected and passive tracking mechanisms utilized.

Considerations. The disclosure responsibilities set forth in this proposed provision are many. The language of this provision is taken by the Iowa Board of Medicine (“IBM”) directly from the Federation of State Medical Board’s recently adopted “Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine.” The IBM, however, goes one step further by proposing this policy statement as a disciplinary requirement for physicians using telemedicine.

The disclosure requirements may be appropriate for and within the capabilities of an entity offering telemedicine services. To impose this obligation upon the individual physician using telemedicine goes too far. This model policy language might more appropriately be part of a similarly adopted model policy of the IBM and/or others to guide telemedicine delivery in Iowa. This disclosure provision as currently drafted, however, is not a medical standard nor is it an appropriate matter for physician discipline.

Requirements (standards) for physicians – facility or physician responsibility?

Proposed rule 653-13.11(13) – Emergency Services

Proposed rule 653-13.11(15) – Privacy and Security

Proposed rule 653-13.11(18) – Patient Access and Feedback

Proposed rule 653-13.11(16) – Technology and equipment

Summary. The physician using telemedicine must: (1) establish written protocol for referral of a patient to an acute care facility or emergency department when necessary for the safety of the patient in case of an emergency; (2) ensure that all telemedicine encounters comply with HIPAA’s privacy and security measures and establish written protocols addressing matters such as health care personnel authorized to process messages, types of transactions to be transmitted electronically, quality oversight mechanisms, and archival and retrieval, which protocol must be evaluated periodically; (3) ensure the patient has access to mechanisms for accessing, supplementing, or amending patient-provided personal health information, giving feedback on the quality of the telemedicine services provided, and registering complaints, including how to file complaints with the IBM; and (4) ensure that technology and equipment used for telemedicine service delivery comply with relevant safety laws and technical safety codes, are of sufficient quality, size, resolution, and clarity needed to provide the medical services, and are compliant with HIPAA.

Considerations. Telemedicine service delivery generally involves physicians, hospitals and others, each of whom have roles and responsibilities for safe and effective telemedicine care. Many of the requirements imposed by these specific provisions  as “standards of practice” for physicians more appropriately are expectations for hospitals or other entities that purchase, maintain, and offer telemedicine services. It seems neither reasonable nor appropriate to place such regulatory expectations, subject to discipline for non-compliance, upon the individual telemedicine physician.

To illustrate, AMA policy H-480.946 on telemedicine says that “physicians, health professionals, and entities that deliver telemedicine services” must establish protocols for referrals and emergency services. The Federation of State Medical Boards addresses these issues within its “Model Policies for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine,” (adopted in April 2014). The FSMB policy on referrals for emergency services says that an emergency plan is required; it does not say the physician is singularly responsible for its development. The physician, however, must be prepared to implement that plan if a referral to an acute care facility or ER is necessary. By way of contrast, the IBM’s proposed rule on emergency services requires the physician who uses telemedicine to establish written protocol for referral of the patient to an acute care facility or emergency department.

Language in a disciplinary rule is important. These specific provisions call for further examination and drafting consideration before adoption. As noted above, these matters of telemedicine delivery of care might be better addressed as model policies or principles for telemedicine delivery in our State particularly in the absence of specific legislative directions from the Iowa General Assembly on telemedicine regulation. The IBM should not attempt to regulate all matters of telemedicine delivery through imposed disciplinary standards on physicians.

The October 24, 2014 posting (last in this series) addresses practical implications for physicians in meeting several of the proposed rule’s requirements  as well as the proposed rule’s specific requirements re: financial interests, links to internet sites, prohibited relationships with preferred pharmacies, and  prohibited internet transactions for prescribing controlled substances.

See our page dedicated to Telemedicine for all related articles, including our most current post.

This October 22, 2014 posting addresses the proposed telemedicine rule’s requirement that physicians using telemedicine must personally assess the education, training, experience and abilities of each non-physician health care provider who requires physician supervision.

Non-physician health care providers requiring physician supervision – qualifications and scope – electronic availability of the physician

Proposed rule 653-13.11(9)

Summary. If a physician who uses telemedicine relies upon or delegates medical services to a non-physician health care provider who requires physician supervision, the physician must ensure that each non-physician health care provider is qualified and competent to safely perform each medical service being provided by personally assessing each non-physician health care provider’s education, training, experience, and ability. The physician must further ensure that services being provided by each such non-physician health care provider are within their respective scopes of practice, including their education, training, experience, ability, licensure and certification. The physician must be available electronically to consult with the non-physician health care provider, particularly in cases of injury or emergency.

Considerations. This rule imposes significant responsibilities upon individual physicians that now do not exist at this level of detail when the physician provides the same medical care services in-person, for instance, in a hospital or other facility setting. Is it realistic and necessary to require an individual physician using telemedicine to personally assess the qualifications of each such non-physician provider the physician relies upon or delegates medical services to? Physicians should be able to reasonably rely upon the credentialing functions and employment decisions of those facilities in which they practice and which offer telemedicine services the physician uses unless circumstances would dictate otherwise.

AMA policy H-480.946, “Coverage of and Payment for Telemedicine,” adopted by the June 2014 House of Delegates, does not include a provision such as this one as a safeguard for telemedicine delivery of care. The Federation of State Medical Boards (FSMB), in its “Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine (adopted in April 2014), says that physicians who provide medical care, electronically or otherwise, should properly supervise non-physician clinicians. The FSMB report does not suggest or require personal assessment of each non-physician clinician’s credentials by the telemedicine physician.

The intent of this proposed provision is a good one: any non-physician health care provider engaged in telemedicine must be qualified, competent, and licensed or certified to do so. It is inarguable that a physician must delegate medical services only to medical personnel competent and qualified to provide those medical services. The question here is the extent to and circumstances under which a physician using telemedicine should be required by IBM rule to personally assess those such criteria for each non-physician health care provider requiring physician supervision. This provision seems to suggest that the physician must personally credential the individual non-physician provider.

Failure to comply with the micro-details of this proposed standard can result in licensee discipline by the IBM and potentially serve as evidence of a misstep in a professional liability case alleging negligent delegation or supervision. Redrafting of this particular provision could bring appropriate focus and establish fair and reasonable expectations of physicians who rely upon other medical practitioners in providing medical services via telemedicine. In its current form, this proposed standard appears neither reasonable nor workable.

The October 23, 2014 posting will addresses the proposed rule’s requirement for disclosures and functionality of telemedicine services and other provisions of the proposed rule that may be less the responsibility of physicians who use telemedicine and more the responsibility of entities that purchase, offer and maintain telemedicine equipment and services used by the physician.

See our page dedicated to Telemedicine for all related articles, including our most current post.

Medical history and physical examination – requirements – internet questionnaires not adequate. 

Proposed rule 653-13.11(8) Medical history and physical examination.

Proposed rule 653-13.11(20) Circumstances when a physician may not personally examine a patient.

Proposed rule 653-13.11(22) Medications or treatment regimens that can only be administered by a physician.

Summary. A physician licensee using telemedicine shall ensure that the patient receiving the medical service is interviewed for relevant medical history and receives a physical examination, when medically necessary, sufficient for the diagnosis and treatment of the patient prior to providing treatment, including issuing prescriptions, electronically or otherwise. Generally, the physician shall perform the in-person medical interview and physical exam. However, the medical interview and physical exam may not be in-person if the technology utilized in the telemedicine encounter is sufficient to establish an informed diagnosis as if the medical interview and physical exam had been performed in-person.

An internet questionnaire, alone, does not constitute an acceptable medical interview or physical exam for providing treatment, including issuing prescriptions electronically or otherwise.

In a separate section, the proposed rule lists limited instances in which it may be suitable for a physician to treat a patient even though the physician has not personally interviewed, examined and diagnosed that patient. Listed circumstances include, among others, when a physician licensee prescribes medications on a short term basis for a new patient and has scheduled an appointment to personally examine the patient; or where the physician is on call for another physician who has an established physician-patient relationship with the patient; or where the patient has been examined in-person by an advanced registered nurse practitioner or physician assistant with whom the physician licensee has a supervisory or collaborative relationship.

Considerations. This proposed rule is consistent with that provision of AMA policy H-480.946 which calls for collection of the patient’s medical history as part of the provision of any telemedicine service. The proposed rule’s requirement for a physical exam is not specifically set out in this AMA policy. Physicians reviewing this proposed provision should particularly note that ordinarily the IBM expects the telemedicine physician to perform the medical interview and physical examination of the patient in person. Yet, the provision only calls for the physical examination “when medically necessary” and recognizes that the physical exam and medical interview may not be performed in person if the telemedicine technology is sufficient to meet this obligation as if the exam and interview had been conducted in person. Finally, the rule lists several limited instances in which a personal exam of a patient may not be required (a provision that appears to be generally applicable to the practice of medicine, not only to telemedicine).

Careful review of this requirement and its exceptions is important to assure quality medical service delivery via telemedicine while also assessing the feasibility and necessity of this provision’s requirements, especially for a physical exam, in the various instances of telemedicine care. Again, physicians stand to be disciplined for non-compliance with this provision. A physician using telemedicine but not performing an in-person medical interview and physical exam would need to show compliance with a stated exception in not doing so. Further clarity may be needed.

Special note might be made of the specific applicability of a prior medical interview and physician exam, if medically necessary, prior to issuing a prescription. Further, physicians may not rely upon an internet questionnaire for a medical interview and physical exam prior to treatment, including issuing a prescription. It appears that the requirements of these provisions are generally applicable to all prescriptions and to all physicians, not just in instances of medical services provided via telemedicine. This may be a drafting issue. If meant, however, to have broad application, the IBM might consider providing separate notice of these proposed provisions to assure adequate review, questions, and comments by physicians.

Note re: the IBM’s current rule on drug-induced abortions via telemedicine. On a related matter, the IBM specifically states in a separate provision in this proposed rulemaking (653-13.11(22)), that nothing in the proposed rule is meant to contradict or supersede the IBM’s already adopted rule 653-13.10 on standards for physicians who prescribe or administer abortion-inducing drugs. That rule requires the physician using telemedicine to provide this specific service to perform a physical examination of the woman to determine and document the gestational age and intrauterine location of the pregnancy. The IBM’s telemedicine abortion rule was legally challenged and upheld in its entirety by a ruling of the Polk County District Court entered August 18, 2014. That case is now on appeal before the Iowa Supreme Court. The Supreme Court has stayed the effective date of the rule, putting it on hold until a decision on appeal has been entered.

The October 22, 2014 posting will address the proposed rule’s requirement that physicians using telemedicine must personally assess the education, training, experience and abilities of each non-physician health care provider who requires physician supervision.

See our page dedicated to Telemedicine for all related articles, including our most current post.