On December 13, 2016, President Obama signed the 21st Century Cures Act (“Cures Act”), Pub. L. 114-255, which aims to expand medical research and expedite the approvals of drug therapies for patients. The Cures Act also contains several provisions related to the HIPAA Privacy and Security Rules. None of these provisions make substantive changes to the HIPAA regulations at this time; in several instances, they direct the Secretary of Health and Human Services (“HHS”) to study whether the HIPAA regulations should be revised or clarified to remove any potential barriers to optimal patient care and communication or to the availability of patient information for medical research.
Tom Price, the Republican representative from Georgia, has been tapped by President-elect Trump as the new Secretary for the Department of Health and Human Services (HHS). Rep. Price is himself an orthopedic surgeon and comes from a family of doctors and, as a result, is focused closely on the ways in which government regulations burden the doctor-patient relationship. At an American Enterprise Institute event this past June, Rep. Price criticized the Affordable Care Act for allowing the government, rather than doctors and patients, to control the manner in which healthcare is offered.
We have followed (here and here) the adoption of the Interstate Medical Licensure Compact (“IMLC”) by various states and the subsequent formation of a commission under the IMLC. We believe that the IMLC presents one promising avenue for the proliferation of telemedicine. In this post, we explore another initiative designed to encourage the development of telemedicine; parity laws.
Telemedicine parity laws require reimbursement for telemedicine services in the same manner and at the same reimbursement amount as for analogous in-person medical treatment. According to the American Telemedicine Association, 7 States have proposed or pending parity legislation, 31 States have already enacted some kind of parity law and 48 States have implemented parity in their Medicaid programs through regulation or legislation.
While these laws have spread quickly, there are many important distinctions among them. Some of these distinctions are worth careful consideration. For example, some States have adopted laws or policies that apply only to Medicaid. Other States have passed legislation that binds private payers as well.
There are plenty of advocates on both sides of the private payer issue. Many telemedicine proponents argue that parity legislation ought to apply to private payers because parity requirements will spur development of cheaper and more effective delivery of services. Critics point out that market forces make such legislation unnecessary; if telemedicine is actually more effective, private payers would have their own incentives to pay as much or more for it, and if telemedicine services are not as effective but are attractive mainly for their cost-saving potential, private payers should be able to adjust the reimbursement and reap the savings accordingly. While this fight continues to rage, most States have concluded that parity, at least with respect to Medicaid, makes sense.
Some States have also adopted separate requirements for obtaining informed patient consent (Michigan is set to become the most recent). Since telemedicine is a relatively new way for patients to obtain care, some States have mandated that patients receive information about what to expect prior to treatment. Proponents of these laws describe them in terms of consumer protection and laud the transparency that they create. Critics tend to argue that state-wide disclosure requirements stifle innovation by implementing a one-size-fits-all regime that places telemedicine at a competitive disadvantage to in-person care, which does not have to meet additional informed consent requirements. They argue that creating this kind of advantage for in-person care might inappropriately slow the implementation of telemedicine solutions.
In March, Florida inched toward telemedicine parity by creating the Telehealth Advisory Council to recommend ways to “increase the use of accessibility of services provided by telehealth.” The Council, which has already begun to hold meetings, will base its recommendations on research conducted by the Agency for Health Care Administration and other regulators into the types, prevalence, cost savings, and reimbursement practices of telemedicine services. While Florida created a council to analyze the issue before enacting substantive legislation, many states adopted legislation without studying the issue or studied it more informally. Florida’s approach is not entirely new, as Indiana completed a one-year pilot program before enacting permanent legislation this year.
States also vary in their methods of regulation. Some States have treated the regulation of telemedicine as an element of preexisting medical regulations, while others have conceptualized it as wholly new and requiring its own regulatory paradigm. For example, while Indiana empowered its existing State Licensing Board to develop regulations to implement the legislation, Idaho created a new Telehealth Council for the same purpose. This example illustrates the difficult balance States will need to create as they integrate telemedicine regulation with preexisting practice rules and try to address the wholly new problems and opportunities that it presents.
On November 29, 2016, the Senate unanimously passed the Expanding Capacity for Health Outcomes Act (the ECHO Act). This legislation seeks to expand the use of technology to connect underserved communities with critical health care services.
In July of 2015 we noted that nine states had enacted laws to join the Interstate Medical Licensure Compact. We described this cooperative program intended to allow physicians to obtain expedited licenses to practice in multiple states. This would facilitate the delivery of telemedicine across state lines; physicians are generally prohibited from practicing, even remotely, in states in which they are not licensed.
In our last post, we noted that enough states had approved the Compact for an Interstate Medical Licensure Compact Commission (Commission) to be formed to promulgate bylaws for licensure. Since then, nine more states have enacted legislation joining the IMLC including, most recently, Pennsylvania. As more states joined, a Commission was indeed formed.
Recently, the Commission issued a proposed rule for “expedited licensure” and met to set a target goal of January 2017 for the finalization and implementation of that rule. Although the Commission has not yet finalized the rule, because the implementation date is fast approaching, we have summarized the likely procedure for expedited licensure.
Most importantly, the Commission plans to create an online application for expedited licensure. The Commission will then transmit that information to the relevant state(s). In addition, the proposed rule describes the requirements to receive an expedited license, which include licensing and educational standards. Applicants who have been convicted of various kinds of misconduct will not be eligible for expedited licensure.
In order to apply for an expedited license from a new state, an applicant will simply submit an online application (including service fees) to the Commission and then submit a fingerprint packet or other biometric data sample and provide a sworn statement attesting to the truthfulness of all of the information provided to the state in which the applicant is currently licensed. The Commission will request that the state in which the applicant is licensed issue a letter of qualification to the applicant and the Commission. Upon receipt of the letter of qualification, the Commission will issue a full and unrestricted license to the applicant to practice in participating states.
Physicians who would like to engage in practice outside of the states where they are currently licensed should check to see if the IMLC applies in the states in which they are licensed and in the states where they would also like to practice. This procedure will probably be available soon and will probably make applications for licensing significantly easier. It is also worth noting that there are many states still considering adopting the IMLC, including Michigan which has active legislation on the topic.
The Department of Health and Human Services (HHS) recently published guidance on HIPAA requirements governing the use of cloud computing entities, specifically cloud services providers (CSPs).
In this guidance, HHS explains that CSPs that create, receive, maintain, or transmit protected health information (PHI) on behalf of a covered entity or business associate are considered business associates under HIPAA, and are therefore subject to HIPAA’s requirements. HHS expressly rejects the idea that CSPs are analogous to “conduits”(such as internet service providers) that provide transmission-only services. Rather, HHS explains that CSPs store and maintain PHI and thus have ongoing and routine access.
We have discussed this guidance on the Inside Medical Devices blog. Covered entities and business associates that rely on CSPs should take steps to ensure that they are in compliance with HIPAA’s requirements.
Last month, the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) released a new guide for prospective buyers of Electronic Health Record systems (EHRs). ONC provides detailed information and suggestions that merit the serious consideration of anyone that contracts or plans to contract with an EHR vendor.
ONC begins with a broad introduction that explains what kinds of options exist and offers advice on how to select an appropriate system. Then, ONC provides detailed advice on a number of important topics, including safety and security, system performance, data rights, interoperability, IP, risk management, dispute resolution, and transitions. For each of these topics, ONC identifies common pitfalls and provides buyer friendly form contract language. Sprinkled throughout the guide are descriptions of common pitfalls and advice about how to avoid them. Some of these points are worth further emphasis.
ONC notes that some buyers have complained about inconsistencies between vendor demonstrations and their actual products. It is important to remember that marketing materials and demonstrations are not necessarily reliable. ONC suggests requiring that any such materials presented to a buyer be attached and incorporated into the final EHR contract. Furthermore, core service and performance obligations should be memorialized with express warranties. This should provide some security against falling victim to a bait and switch.
Earlier this week the Government Accountability Office released a report critiquing the U.S. Department of Health and Humana Services’ (HHS) oversight of and guidance related to health information security and privacy. (The report is available here.)
GAO cited the increasing incidence of hacking and other breaches, which affected over 113 million health records in 2015, as a key reason to ensure that HHS provides appropriate guidance to and oversight of covered entities and business associates. Hacking and other breaches may result in identify theft, fraud, disruption of health care services, and even national security threats.
GAO’s concerns fell into two primary categories: those related to HHS’s guidance to covered entities and business associates, and those related to oversight efforts. Continue Reading
Last month, the Office of Management and Budget (“OMB”) began its review of the much-discussed new Health IT Certification regulations, which include enhanced oversight of Electronic Health Records (“EHRs”) technology by the Office of the National Coordinator for Health Information Technology (“ONC”).
A research letter published this month in the Journal of the American Medical Association reported that only a small fraction of seniors in the United States use digital health technology. The authors applied statistical analysis to data gleaned from a nationally representative sample of Medicare beneficiaries age 65 and older. In 2011, 16% of seniors obtained health information, 8% filled prescriptions, 7% contacted clinicians, and 5% handled insurance using digital health technology. For comparison, 64% of seniors used computers and 43% used the internet. By 2014, among the respondents who survived and could be reached for follow up, the numbers remained largely constant (with none increasing by more than a few percentage points).
The study thus shows that digital health “is not reaching most seniors” and accordingly is not improving health care quality, cost, and safety as much as possible. “Future innovations,” the authors conclude, “should focus on usability, adherence, and scalability to improve the reach and effectiveness of digital health for seniors.”