Telehealth Archives - Page 19 of 33

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The Joint Commission Puts the Brakes on Text Messaging Patient Orders

by Sandra M. DiVarco | Dec 28, 2016 | Data Privacy, General Interest, Telehealth, Text Messaging, Uncategorized

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

by McDermott Will & Emery, Bernadette M. Broccolo and Lisa Mazur | Dec 20, 2016 | General Interest, Mobile Apps, Telehealth

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.

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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.

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Digital Health’s Perfect Storm of Regulators

by McDermott Will & Emery, Bernadette M. Broccolo and Lisa Mazur | Dec 19, 2016 | General Interest, Telehealth

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.

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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

by Daniel F. Gottlieb, Jennifer S. Geetter, Karen S. Sealander, Lisa Mazur and Scott Weinstein | Dec 13, 2016 | Consumer Protection, Data Privacy, Telehealth

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.

Congress Continues to Focus on Integrating Telehealth Solutions into Healthcare Delivery

by McDermott Will & Emery, Lisa Mazur and Marshall E. Jackson, Jr. | Dec 7, 2016 | Telehealth

On December 6, 2016, the House passed the Expanding Capacity for Health Outcomes Act (S. 2873) (the ECHO Act), which was unanimously passed by the Senate on November 29, 2016. The ECHO Act seeks to expand the use of health care technology and programming to connect underserved communities and populations with critical health care services.

The ECHO Act builds upon the University of New Mexico’s world-renowned Project ECHO by encouraging the broader development and use of technology-enabled collaborative learning and care delivery models by connecting specialists with multiple other health care professionals through simultaneous interactive videoconferencing for the purpose of facilitating case-based learning, disseminating best practices, and evaluating outcomes.

The ECHO Act requires the Secretary of the Department of Health and Human Services (HHS) to study technology-enabled collaborative learning and capacity building models, and the impact of those models on (1) certain health conditions (i.e., mental health and substance use disorders, chronic diseases, prenatal and maternal health, pediatric care, pain management, and palliative care), (2) health care workforce issues (e.g., specialty care shortages) and (3) public health programs.

Within two years of the enactment of the ECHO Act, the Secretary of HHS must submit a publically available report to Congress that:

Analyzes the impact of technology-enabled collaborative learning and capacity building models, including, but not limited to, the impact on health care provider retention, quality of care, access to care and barriers faced by healthcare providers;
Lists the technology-enabled collaborative learning and capacity building models funded by HHS over the past five years;
Describes best practices used in adopting these models;
Describes barriers to adoption of these models and recommends ways to reduce those barriers and opportunities to increase use of these models; and
Issues recommendations regarding the role of technology-enabled collaborative learning and capacity building models in continuing medical education and lifelong learning, including the role of academic medical centers, provider organizations and community providers in such education and lifelong learning.

The recommendations made in HHS’s report may be used to integrate the Project ECHO model into health systems across the country.

Bipartisan Legislation Proposes Telehealth Solutions for Effective Chronic Disease Management

by Dale C. Van Demark, Lisa Mazur and Marshall E. Jackson, Jr. | Nov 28, 2016 | General Interest, Telehealth

Collaborative efforts between congressional offices and various health care stakeholders, as well as the feedback provided in response to the Bipartisan CHRONIC Care Working Group Policy Options Document released in December of 2015, have driven the Senate Finance Committee to introduce a draft of bipartisan legislation known as the CHRONIC Care Act, which seeks to modernize Medicare payment policies to improve the management and treatment of chronic diseases using telehealth.

Read the full article.

Commercial Insurers Urge Congressional Budget Office to Consider their Telemedicine Data

by Lisa Mazur | Oct 28, 2016 | General Interest, Telehealth

In hopes of expanding reimbursement opportunities for telemedicine services in the Medicare program, representatives of eleven payers, including Aetna, Anthem, Blue Cross Blue Shield of Tennessee, Cambia Health Solutions and Humana, asked CBO director Keith Hall in a public letter to consider their data when evaluating the impact of Medicare coverage of telemedicine services.

Medicare reimbursement for telemedicine is currently limited to very narrow set of circumstances. Section 1834(m) of the Social Security Act provides that telehealth services are covered only if the Medicare patient is seen: (a) at an approved “originating site” (e.g., physician offices, hospitals, skilled nursing facilities) that is located within a rural Health Professional Shortage Area (HPSA) that is either outside of a Metropolitan Statistical Area (MSA) or in a rural census tract, or a county outside of a MSA; (b) by an approved provider (e.g., physicians, nurse practitioners, clinical psychologists); (c) for a defined set of services, including consultations, office visits, pharmacological management, and individual and group diabetes self-management training services; and (d) using certain telecommunications technologies.

There are bipartisan efforts currently underway to expand Medicare reimbursement for telemedicine services by easing or eliminating some of these requirements. One example is the CONNECT for Health Act. Because coverage of telemedicine services in Medicare’s fee-for-service program is limited, there is limited Medicare data available for the CBO to consider when reviewing the potential financial impact of such legislation. In light of this lack of data, the insurers advise that the CBO should consider the effects that telemedicine’s expansion in the commercial market. The insurers’ letter to the CBO also points out that new alternative, quality-based payment models rely upon telemedicine as a means of meeting certain performance measures, and other government agencies, such as the US Department of Defense and the Veterans Administration, are using telemedicine services to provide better quality care.

Earlier this year, the CBO and MedPAC received a letter from over 20 different health care providers similarly urging it to consider alternative data sources, such as data from the commercial sector, when analyzing the costs and benefits associated with the use of telemedicine in the Medicare program.

FTC Weighs-in on Telehealth, Comments on Delaware’s Occupational Therapy Practice Rule

by McDermott Will & Emery, Ashley Fischer, Lisa Mazur and Marshall E. Jackson, Jr. | Sep 15, 2016 | General Interest, Mobile Apps, Telehealth

On August 3, 2016, the Federal Trade Commission (FTC) staff submitted public comments regarding the Delaware Board of Occupational Therapy Practice’s proposed regulation for the provision of occupational therapy services via telehealth in Delaware (the Proposed Regulation). The FTC’s comments to the Proposed Regulation follow its comments to Alaska’s telehealth legislation earlier this year and evidence its continued focus on telehealth’s ability to foster flexibility in health care delivery by increasing practitioner supply; encouraging competition; and improving access to affordable, quality health care.

By way of background, in 2015, Delaware amended its Insurance and Professions and Occupations Code (the Code) to include the regulation of telehealth and telemedicine services, including the delivery of occupational care remotely under existing, in-person standards of care. Consistent with the Code, the Delaware Board of Occupational Therapy Practice (the Board) revised its rules and regulations to address telehealth services. The Proposed Regulation defines telehealth as “the use of electronic communications to provide and deliver a host of health-related information and health care services, including occupational therapy related information and services, over electronic devices. Telehealth encompasses a variety of occupational therapy promotion activities, including consultation, education, reminders, interventions, and monitoring of interventions.”

The Proposed Regulation gives Occupational Therapist and Occupational Therapist Assistant licensees’ (Licensees) discretion in assessing and determining the appropriate level and type of care for an individual patient, provided that certain requirements are satisfied. Specifically, under the Proposed Regulation, Licensees that provide treatment through telehealth must have an active Delaware license in good standing to practice telehealth in the state of Delaware. In addition to obtaining informed consent and complying with confidentiality requirements, the licensee must also: (1) be responsible for determining and documenting that telehealth is an appropriate level of care for the patient; (2) comply with the Board’s rules and regulations and all current standards of care requirements applicable to onsite care; (3) limit the practice of telehealth to the area of competence in which proficiency has been gained through education, training and experience; (4) determine the need for the physical presence of an occupational therapy practitioner during any interactions with patients, if he/she is the Occupational Therapist who screens, evaluates, writes or implements the plan of care; (5) determine the amount and level of supervision needed during the telehealth encounter; and (6) document in the file or record which services were provided remotely. (24 Del. Admin. Code § 2000-4.2.)

Staff of the FTC’s Office of Policy Planning and its Bureaus of Competition and Economics, responding to the Board’s request for public comments, stated that by not imposing rigid and unwarranted in-person care and supervision requirements, the Proposed Regulation could have various positive impacts, including: (1) improving access to cost-effective, quality care, especially for patients with limited mobility; (2) reducing Medicaid’s transportation expenditures as well as individuals’ pecuniary and time costs; (3) addressing anticipated workforce shortages in the health care sector by increasing practitioner supply and facilitating care of an aging population; and (4) enhancing competition, consumer choice and access to [...]

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Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

by Michael G. Morgan | Aug 8, 2016 | Consumer Protection, Cybersecurity, Data Privacy, Email/Spam, Telehealth

On July 28, 2016, US Department of Health and Human Services (HHS) issued guidance (guidance) under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and recover from ransomware attacks. Ransomware attacks can also trigger concerns under state data breach notification laws.

The HIPAA Security Rule requires covered entities and business associates to implement security measures. It also requires covered entities and business associates to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic protected health information (ePHI) the entities create, receive, maintain or transmit and to implement security measures sufficient to reduce those identified risks and vulnerabilities to a reasonable and appropriate level. The HIPAA Security Rule establishes a floor for the security of ePHI, although additional and/or more stringent security measures are certainly permissible and may be required under state law. Compliance with HIPAA’s existing requirements provides covered entities and business associates with guidance on how to prevent and address breaches that compromise protected health information. The new HIPAA guidance specific to ransomware reinforces how the existing requirements can help an entity protect sensitive information.

Read the full article here.

Guidance on Low Risk General Wellness Devices Is Finalized

by McDermott Will & Emery, Michael W. Ryan and Vernessa T. Pollard | Aug 4, 2016 | Consumer Protection, General Interest, Mobile Apps, Telehealth

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to the policies articulated in its January 2015 draft guidance. Notably, however, the Final Guidance added and refined several examples to illustrate the products that are subject to FDA’s enforcement discretion and ultimately outside FDA’s intended scope of regulatory oversight.

Read the full article, FDA Finalizes Guidance on Low Risk General Wellness Devices here.