Utah Provides Structure to Telehealth, Expands Access to Mental Health in Proposed Bill

Utah is one of the many states that started off 2017 with proposals to change its existing telehealth laws and regulations. Proposed Utah HB 154 (the Proposed Bill), endorsed by Ken Ivory and Allen Christensen, amends the regulatory infrastructure for telehealth, with a focus on mental health. Two of the key components of the Proposed Bill are listed below:

  • The Proposed Bill creates a scope of telehealth practices within the Utah Health Code. Under the scope of practice requirements, any provider using telehealth to provide care will be held to the same standard of care as that applicable to in-person care. In addition, the Proposed Bill stipulates that a provider may not prescribe using telehealth unless the provider has obtained the patient’s relevant clinical history and documented the relevant clinical history and current symptoms. The provider must also be available for follow-up care and familiar with available medical resources near where the patient was located during the telehealth consult.
  • The Proposed Bill enacts a new provision to the Utah Medical Assistance Act specifically enabling the provision of mental health services—treatment of mental conditions that are approved in the DSM-V—via telehealth technologies. This provision of the Proposed Bill is Utah’s attempt to increase access to behavioral and mental healthcare services in Utah. In particular, the DSM-V addresses substance abuse disorders as mental health disorders, and the telehealth provision will enable providers to help treat addiction using telehealth services where treatment facilities may not otherwise be available. Importantly, the Proposed Bill’s Medical Assistance Act amendment applies to any managed care organization that contracts with Medicaid, or any provider who is reimbursed under the Medicaid program, and requires insurers to disclose whether they provide coverage for telehealth services for mental health as part of the price and value comparison requirement under Utah law.

The Proposed Bill was passed by both the Utah House of Representatives and Senate and was enrolled on February 24, 2017. The Proposed Bill now awaits Governor Gary Herbert’s signature. If approved, the Proposed Bill will greatly expand access to health care for the mentally ill in Utah, and additionally provide more guidance to assist in the expanded use of telehealth and telemedicine services within the state.

Texas to Take a Leap Forward in Telehealth – A Proposed Bill Drops the Controversial In-Person Evaluation Requirement

Texas telehealth requirements will significantly change in the near future if Texas Senate Bill 1107 is passed into law, as it removes the controversial “face-to-face” or in-person consultation requirement to establish a physician-patient relationship and lawfully provide telehealth and telemedicine services within the state. This bill comes after a six-year-long battle between telemedicine stakeholders and the Texas Medical Board, and will better align Texas’ regulations with those found in other states.

Read the full article.

Arkansas is at it Again! Telemedicine Regulation in Arkansas Undergoes Additional Change

Arkansas currently has one of the most restrictive telemedicine environments in the country, and was one of the last states to require an in-person examination to form a provider-patient relationship. Prior to September 2016, Arkansas telemedicine laws required an initial in-person encounter to establish a valid physician-patient relationship. In September 2016, the state expanded the formation of a provider-patient relationship to include a face-to-face examination using both real time audio and visual telemedicine technology that provides information at least equivalent to the information that would have been obtained through an in-person examination.

Then, early last month, Arkansas Senate’s Public Health, Welfare and Labor Committee approved Senate Bill 146, which was signed by the Governor and became Arkansas Act 203 on February 20th, which further amended the state’s telemedicine laws to, among other things, enable patients to access telemedicine services from their home or other remote locations. The Act modified the “originating site” location requirement, redefining “originating site” to permit services to be provided wherever the patient is located at the time of the consult.  While this change has the potential to expand the use of telemedicine in Arkansas, the Act added more to its restriction on the formation of a professional relationship through telemedicine, as it states that a professional relationship cannot be formed through an internet questionnaire, email message, patient-generated medical history, audio-only communication, text messaging, fax machine or any combination of these technologies. This provision reaffirms that a patient relationship can only be formed in Arkansas with an Arkansas-licensed provider utilizing both real time audio and visual technology.

Notably, the Act also has implications for school-based telemedicine programs, which are increasing in popularity across the country. Arkansas requires school-based telemedicine programs that treat Medicaid recipients to utilize either the minor’s regular pediatrician or other primary care physician; a physician with a cross-coverage arrangement with the regular pediatrician or primary care physician; or have authorization from the regular pediatrician or other primary care physician of the minor.  (In most cases, school-based telemedicine programs require a parent’s consent for telemedicine services, and a child’s pediatrician or other primary care provider is notified after the child treated via telemedicine.) This specific provision is particularly protective of the role of treating physicians, but does not include the requirement that a parent or guardian have the power to consent to the formation of a physician-patient relationship with a minor, which is ordinarily expected.

In sum, while the law will not make Arkansas a leader in expanded access to telemedicine, it will help bring Arkansas into line with the rest of the US.

What You Need to Know about Changes to the Common Rule

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data repositories and use of those repositories for secondary research. All stakeholders involved in federally funded research should be aware of the Final Rule’s changes and prepare to implement them.

Read the full article here.

HHS Finalizes Overhaul of Federal Human Subjects Research Protections

On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.” These are the first revisions to the Common Rule since its original enactment in 1991, and have been in progress since HHS first published an Advanced Notice of Proposed Rulemaking in July 2011. According to the press release accompanying the final rule, HHS made “significant changes” to its most recent proposals (published in September 2015) in response to the 2,100+ public comments they received.

The majority of the Common Rule’s changes and new provisions will go into effect in 2018. We are reviewing the final rule in detail, and a summary of changes and new provisions is forthcoming.

OMB Reviewing Common Rule Overhaul

On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often referred to as the Common Rule, were originally developed in 1991 and have been adopted by multiple federal departments and agencies. OMB review is the last step before final publication and suggests that HHS is trying to release a final rule before President Obama leaves office on January 20, 2017.

Through its Office for Human Research Protections (OHRP), HHS initially published an Advanced Notice of Proposed Rulemaking in July 2011. The Advanced Notice generated significant controversy and OHRP did not publish a notice of proposed rulemaking (Proposed Rule) for over four years, ultimately doing so on September 8, 2015. The Proposed Rule, like its earlier Advanced Notice counterpart, suggested major changes to the Common Rule, including changes to its overall jurisdictional scope, requirements relating to secondary use of biospecimens and individually identifiable information, and the general research review and oversight process.

Since the Proposed Rule’s publication, OHRP has received significant feedback from both industry and expert advisory groups about the proposed changes and their overall impact. While certain proposed changes have been applauded, the Proposed Rule has also generated considerable concern and uncertainty among stakeholders.

The current status of OMB’s review is pending.

The Joint Commission Puts the Brakes on Text Messaging Patient Orders

The Joint Commission (TJC) recently clarified that licensed independent providers (LIPs) or other practitioners may not utilize secure text messaging platforms to transmit patient care orders. TJC’s earlier position provided that use of secure text messaging platforms was an acceptable method to transmit such orders, provided that the use was in accordance with professional standards of practice, law and regulation, and policies and procedures.

TJC identified the rationale for the reinstated prohibition against secure text messaging for patient care orders as one of patient safety—after “weighing the pros and cons” TJC and the Centers For Medicare and Medicaid Services (CMS) concluded that as the impact of the modality on patient safety remained unclear, and determined that approving its use was premature.

Read more here about how this clarification impacts health care organizations.

Digital Health Solutions are Key to Success under Health Care Payment Innovations

Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held devices—is empowering the innovation needed to meet the imperative for a transition from payment based on volume to payment based on value that is evaluated in terms of measurable improvements in care delivery and population health.

ODI post 2

One prominent example is the use of digital health solutions to implement the payment innovation contemplated by the Medicare Access and CHIP Reauthorization Act (known as MACRA)—which directly ties both payment increases and reductions to various, specific efficiency and value measures. The Merit-Based Incentive Payment System (MIPS), one of the two available payment pathways under MACRA, assigns points to clinicians in different performance categories, several of which promote the adoption of digital health solutions. To illustrate:

  • The Quality category requires six measures to be reported, many of which may be leveraged through the use of digital health tools. For example, the Maternity Care: Post-Partum Follow-Up and Care Coordination measure tracks the percentage of patients who were seen for post-partum care within eight weeks of giving birth who received particular evaluations, screening and education. Obstetricians, gynecologists and family medicine practitioners could earn points under this measure by using telemedicine technologies, like videoconferencing platform, to engage in virtual patient visits with post-partum patients to answer the patient’s questions, provide education on the recovery process and assess the patient’s physical and mental health status, including the performance of mandatory post-partum depression screenings.
  • The Advancing Care Information category requires the use of certified electronic health record technology to coordinate care through patient engagement (g., secure messaging). The implementation of patient portals with integrated messaging platforms facilitate communication between the patient and health care practitioner, providing additional functionalities like sending reminders, engaging in dialogue about follow-up care, encouraging preventative action and distributing educational materials. These portals typically also give the patient access to timely and informative data, like test results, that allow the patient to play a role in decision making and (hopefully) empower the well-informed consumption of care.
  • The Clinical Practice Improvement category is perhaps the best opportunity for digital health integration. Activities that improve beneficiary engagement, population management, expanded practice access and care coordination—among others—are assigned points and weighted. Here, mobile apps have the capability to enable e-visits via videoconference as an alternative method to an in-person visit; facilitate questionnaire reporting; and send reminders, materials and other notifications to alert and educate patients about services due. The apps also provide opportunities to generally inform the delivery of care for the specific patient by sending alerts to providers to indicate that it’s time for a visit or that a problematic symptom was noted on a questionnaire. Further, clinical practices could leverage app-sourced data to gain information about patient trends, clinical areas of concern or successes related to digital health tool utilization.

For additional examples and insights on how digital health tools will be necessary for a successful transition to alternative payment schemes, please read Managing the Transition to Transformation: Digital Health Solutions: Essential Ingredients in Alternative Health Care Delivery and Payment Innovations.

Digital Health’s Perfect Storm of Regulators

Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the numerous regulatory bodies responsible for overseeing different aspects of digital health. The following illustration identifies the numerous regulatory bodies that have been increasingly focused on the use of technology in healthcare and are expected to continue their focus and enforcement activities in the coming years.

ODI blog

Because innovation is moving faster than the law in this area, in-house counsel and compliance officers must be prepared to identify and manage the myriad compliance and liability risk considerations arising from participation in and use of digital health tools. This will require an understanding of how each of these regulatory bodies oversees and regulates digital health today and close monitoring of how that evolves and changes in the future.

Health care providers, patients and consumers should approach the selection and use of digital health advancements with a reasonable degree of caution. As AMA CEO James L. Madara, MD, advised in his address at the recently concluded 2016 AMA Annual Meeting, “…. Appearing in disguise among these positive products are other digital so-called advancements that do not have an appropriate evidence base … or that just do not work well or that actually impede care, confuse patients and waste our time … from ineffective electronic health records to an explosion of direct-to-consumer digital health products to apps, some of which are of poor quality.” In this regard, providers would be well served by performing sufficient “due diligence” to determine whether the functionality of the digital health tool effectively meets their specific clinical and operational needs, as well as the needs of their patients, and to evaluate the developer’s compliance with applicable laws and regulations.

End of Year Attention to Health IT and Digital Health Tools in 21st Century Cures

On December 7, 2016, the US Congress approved the 21st Century Cures Act (Cures legislation), which is intended to accelerate the “discovery, development and delivery” of medical therapies by encouraging public and private biomedical research investment, facilitating innovation review and approval processes, and continuing to invest and modernize the delivery of health care. The massive bill, however, also served as a vehicle for a variety of other health-related measures, including provisions relating to health information technology (HIT) and related digital health initiatives.  President Barack Obama has expressed support for the Cures legislation and is expected to sign the bill this month.

The HIT provisions of the Cures legislation in general seek to:

  • Reduce administrative and regulatory burdens associated with providers’ use of electronic health records (EHRs)
  • Advance interoperability
  • Promote standards for HIT
  • Curb information blocking
  • Improve patient care and access to health information in EHRs

As public and private payers increasingly move from fee-for-service payments to value-based payment models, with a focus on maximizing health outcomes, population health improvement, and patient engagement, HIT—including EHRs and digital health tools—will be increasingly relied upon to collect clinical data, measure quality and cost effectiveness; assure continuity of care between patients and providers in different locations; and develop evidence-based clinical care guidelines.

Read the full article.

LexBlog