Monthly Archives: January 2016

Telemedicine: Regulatory Framework & Barriers to Expansion

On November 19, the Health Law and Policy Brief hosted its fall symposium “Telemedicine: Regulatory Framework & Barriers to Expansion.” Telemedicine emerged over 40 years ago and is a rapidly expanding area of healthcare in the United States. The panelists at the symposium discussed the current state of Telemedicine, its regulatory framework, and the barriers to its expansion. Mr. Gary Capistrant, the Chief Policy Advisor to the Telemedicine Association, moderated the panels.

The first panel focused on barriers to the expansion of telemedicine. The speakers on the panel were 1) Ms. Alexis Gilroy, Partner at Jones Day; 2) Ms. Amy F. Lerman, Senior Counsel at Epstein Becker Green; and 3) Mr. Jeffrey Mitchell, Of Counsel at Lukas Nace Gutierrez & Sachs LLP.

These three speakers brought up and discussed several important barriers that need to be addressed for telemedicine to reach its full potential. Ms. Alexis Gilroy emphasized that regulation of telemedicine is state by state. Regulators are dealing with a huge number of rules that vary, and there is yet another layer of regulation once telemedicine moves outside of the United States. In some ways, regulators can supervise telemedicine more directly, but varying rules complicate that. A potential solution is to create a federal system of regulation, but that would take away power from states, which raises another host of issues. Ms. Amy Lerman focused on barriers regarding payment. The question from all telemedicine clients is how they are going to get paid. The various state regulatory regimes also have varying reimbursement schemes, which seriously hinder telemedicine, which cannot move forward if they are not paid. Finally, Mr. Jeffrey Mitchell questioned the idea of “universal service.” While technology has made magnificent advances in the last two decades, there is still the problem of affordable access to phones and the Internet in rural areas, which are usually in greater need of telemedicine. Even if rural areas do have access to phones and the Internet, connectivity is constantly an issue. A solution is to subsidize rural phones by overcharging urban businesses, however that comes with its own problems that have yet to be adequately addressed.

The second panel focused on how the federal government regulates mHealth devices. The speakers on this panel were 1) Mr. Daniel Gottlieb, Associate at Epstein Becker Green; and 2) Mr. Robert Jarrin, Senior Director of Government Affairs at Qualcomm.

Both of these speakers built upon the comments of the speakers on the first panel and further elucidated how involved the government is in regulating telemedicine. Mr. Daniel Gottlieb described the various ways that the federal government regulates mHealth devices. Mr. Gottlieb began by applauding telemedicine saying that clinical data obtained through its programs has immense potential to spur medical advances. He explained that clinical and IT personnel collaborate in telemedicine programs. The Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Federal Communications Commission (FCC) then regulate their efforts. If certain programs work with patients in the European Union (EU), they then also must comply with the EU Data Privacy Directive. His points echoed those of Ms. Gilroy. While careful regulation is necessary for safety purposes, Mr. Gottlieb emphasized a need to streamline the regulation of telemedicine. Mr. Jarrin’s points reiterated the fact that there are several regulatory bodies involved in telemedicine. As the Senior Director of Government Affairs for Qualcomm, Mr. Jarrin emphasized that he is responsible for 1) state and federal laws pertaining to telemedicine; 2) FDA regulatory oversight over mHealth devices; 3) congressional committees’ perspectives; 4) Medicare and Medicaid telehealth reimbursement; and 5) FCC broadband healthcare efforts. Compounding these responsibilities is how much of a risk a device is. The FDA classifies devices in different groups based on risk; however determining risk is a complicated process. Mr. Jarrin called for more guidance and transparency from government agencies, particularly the FDA.

The symposium was a wonderful event, and the AUWCL community was incredibly lucky to have such knowledgeable speakers come and offer their expertise.


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Even with the ACA, is healthcare in America bankrupting its citizens?

A recent New York Times/Kaiser Family Foundation survey found that 1 in 5 insured American’s struggle to pay medical related expenses. On March 23, 2010, President Obama signed the Affordable Care Act, which enacted comprehensive health care reform. The massive law contains countless provisions, with some of the most controversial and contested being the individual and employer mandates. Due in part to the mandates, decreased costs of yearly/monthly premiums, and restrictions on denying coverage for pre-existing conditions, the uninsured rate has dropped 6 percent, from 15.1 percent to 9.2 percent, since the ACA was enacted. Despite the impressive increase in insured American’s, the new NY Times/Kaiser study suggests that insuring more Americans is only one part of solving America’s mounting healthcare problems.

The study suggests that many Americans are taking second jobs, working longer hours, or cutting back on household expenses to pay the costs of medical treatment not covered by their insurance. Margot Sanger-Katz, in a NY Times article summarizing the study, suggests that although insurance premiums are lower, the lower premiums are offset by higher deductibles. The article highlights several examples of Americans that were blindsided by unexpected medical bills, including one individual who lost her home due to extensive medical costs despite being insured. Is there any solution to this growing problem? President Obama’s administration is constantly battling attacks on the ACA. Given Congress’ recent attempt to repeal portions of the ACA, which President Obama not surprisingly repealed on Friday, January 8th , it seems unlikely that Congress will pass any additional legislation to further regulate the insurance industry. What relief do Americans have when it seems that the only way to avoid medical debt is to stay healthy?

The Huffington Post suggests that the situation is not so bleak for at least some sectors of the population. “The data from the Centers for Disease Control and Prevention show that the number of people in households that faced problems paying medical bills decreased by 12 million from the first half of 2011 through the first six months of this year.” The data further suggests that “among the poor, the share of those with problems fell from 32.1 percent to 24.5 percent,” which is an even more significant decrease in problems than their middle-class counterparts.

With the uninsured rate at historic lows, and still many Americans struggling to make ends meet while receiving needed medical treatments, additional health care reform seems necessary. However, given the current political landscape and Congress’ overwhelming disdain for health care reform introduced by the current administration, it seems unlikely that much-needed change will occur. Where does that leave American’s who are facing the life-changing decision of depleting hard-earned savings to have a fighting chance at treatment, surgery or recovery? A recent article from the Las Vegas Review Journal suggests negotiating upfront with hospitals for fair rates can help control mounting medical expenses. However, more often than not, staying healthy is the best way to avoid medical debt and keep hard-earned money in the bank.


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