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Round Two: Significant Telehealth Expansion Re-Proposed in Bipartisan Senate Bill

On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the legislation in early 2016 and referred to the Senate Committee on Finance. As we previously reported on February 29, 2016, this iteration of the proposed bill also focuses on promoting cost savings and quality care under the Medicare program through the use of telehealth and remote patient monitoring (RPM) services, and incentivizing such digital health technologies by expanding coverage for them under the Medicare program—albeit using different terminology. Chiefly, the CONNECT Act of 2017 serves as a way to expand telehealth and RPM for Medicare beneficiaries, makes it easier for patients to connect with their health care providers and helps reduce costs for patients and providers. As with the previous iteration, the CONNECT Act of 2017 has received statements of support from over 50 organizations, including the American Medical Association, American Telemedicine Association, Healthcare Information and Management Systems Society, Connected Health Initiative, Federation of State Medical Boards, National Coalition on Health Care and an array of vendors and health systems. (more…)




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OIG Reports More Than $731 Million in Inappropriate Medicare Meaningful Use Payments

The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US Department of Health and Human Services (OIG) describing inappropriate payments to physicians under the program. The report follows on the heels of a high-profile settlement under the False Claims Act between the US Department of Justice and an EHR vendor related to certified electronic health record technology (CEHRT) used in the EHR Incentive Program (which we’ve previously discussed in-depth).

The OIG reviewed payments to 100 eligible professionals (EPs) who received EHR incentive payments between May 2011 and June 2014 and identified 14 inappropriate payments. OIG extrapolated the results of the review to the 250,470 total EPs who received incentive payments during that time period and estimated that CMS made approximately $729 million in inappropriate EHR incentive payments out of a total of just over $6 billion in such payments during the review period. (more…)




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Texas Changes its Tone on Telemedicine

As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been actively monitoring Texas’ approach to telemedicine regulation and the related Teladoc case. Texas has eliminated its most restrictive requirement for delivering care via telemedicine in Texas, increasing opportunities for providers to reach patients using technology.  Senate Bill 1107 was passed on May 11, 2017, and the House added an amendment in passing Senate Bill 1107, which was approved in the Senate on May 18.  The bill was signed into law by Governor Abbott last weekend.

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Recent $2.5 Million OCR Settlement Is a Warning to Wireless Health Service Providers

On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on the impermissible disclosure of unsecured electronic protected health information (ePHI) by a provider of remote mobile monitoring, with a focus on patients who are at risk for cardiac arrhythmias.

In January 2012, the remote monitoring company reported that a workforce member’s laptop containing the ePHI of over a thousand individuals was stolen from a parked vehicle outside of the employee’s home. A little over one year later, the same company reported a second breach that compromised the ePHI of twice as many individuals (details regarding this breach were not provided by OCR).

OCR’s investigation revealed that the company allegedly had insufficient risk analysis and risk management processes in place at the time of the theft. Additionally, the company’s draft policies and procedures implementing the standards of the HIPAA Security Rule had never been implemented, and the company was also unable to produce final versions of any policies or procedures regarding the implementation of safeguards for ePHI, including those for mobile devices.

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More Federal Legislation Aimed at Expanding Medicare Coverage of Telehealth Services

Late last month, Senator Cory Gardner (R-CO) and Senator Gary Peters (D-MI) introduced Senate Bill 787, the Telehealth Innovation and Improvement Act (Telehealth Improvement Act), which is focused on expanding Medicare’s currently limited coverage of telehealth services and opportunities for innovation.

The Telehealth Improvement Act would require the Center for Medicare and Medicaid Innovation (CMMI) to test the effect of including telehealth services in Medicare health care delivery reform models. More specifically, the Act would require CMMI to assess telehealth models for effectiveness, cost and quality improvement, and if the telehealth model meets these criteria, then the model will be covered through the Medicare program. (more…)




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New York AG Settlement with App Developers Serves as a Warning for the Need for Evidence-Backed Commercial Claims

On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims. This settlement highlights for mHealth app developers the importance of systematically gathering sufficient evidence to support their commercial claims.

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The TCPA: An Unexpected Deterrent to Patient Engagement Tools

In an age where providers are increasingly taking the management of their patient’s health online and out of the doctor’s office, the creation of scalable and nimble patient engagement tools can serve to improve patient experience, health care outcomes and health care costs. While the level of enthusiasm for these tools is at an all-time high, there is a growing concern about the unexpected deterrent to the adoption of these tools from an unlikely source: the Telephone Consumer Protection Act of 1991 (TCPA).

Many professionals in the health industry have come to share two misconceptions about the TCPA: first, that the TCPA only applies to marketing phone calls or text message “spam,” and second, that the TCPA does not apply to communications from HIPAA covered entities to their patients/health plan members. These misconceptions can be costly mistakes for covered entities that have designed their patient engagement outreach programs without include a TCPA compliance strategy.

Compliance Challenges

As discussed in a previous post, the TCPA was originally intended to curb abusive telemarketing calls. When applying the law to smarter and increasingly innovative technologies (especially those that we see in the patient engagement world), the TCPA poses significant compliance challenges for the users of these tools that arguably threaten to curb meaningful progress on important public health and policy goals.

Despite its initial scope of addressing robocalls, the TCPA also applies to many automated communications between health care providers and their patients, and between plans and their members. There is a diverse array of technical consent requirements that apply depending on what type of phone call you make. For instance, most auto-dialed marketing calls to cell phones require prior express written consent, meaning that the caller must first obtain written consent before making the call. To make compliance more compliance, callers remain responsible for proving consent and the accuracy of the numbers dialed.

Indeed, the TCPA presents a serious challenge for patient engagement tools, especially when violations of the TCPA can yield statutory damages of up to $1,500 per call or text message. While Federal Communications Commission orders over the past several years have added some clarity and a “safe harbor” for HIPAA-covered entities to help entities achieve compliance, there is still no “free pass” from the TCPA’s requirements. Therefore, covered entities and the business associates who work for them should not assume that compliance with HIPAA offers any security of defense against a successful claim under the TCPA.

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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.




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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.

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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.




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