Category: Blog

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.

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.

For the first time since Congress passed FLSA in 1938, home health aides, also known as domestic service workers, are now eligible for minimum wage and overtime pay. Earlier this month, Chief Justice Roberts denied Home Care Association of America’s request for stay of issuance of mandate in the case Home Care Association of America v. Weil.

Home Care Association made waves across the labor law and health care industry this past August when the D.C. Circuit Court upheld Department of Labor (DOL) regulations that extend minimum wage and overtime protections to home health aides. Home Care Association may still appeal, but legal experts muse that even if the appeal is granted, it is unlikely to prevail.

Labor activists heralded the decision as a momentous occasion for the domestic work industry. The home health aide industry encompasses nearly two million domestic workers—and expanding. It is the fastest-growing occupation in the nation. Domestic workers typically operate behind closed doors in a highly unregulated economy with little workplace protections. As a result, labor trafficking and exploitation are consistent concerns in the industry.

In the decades since its inception in 1938, the Fair Labor Standards Act (FLSA) has left out home care aides and exempted them from wage-and-hour requirements. Some labor activities charge that the exemption is driven by racism against a class of workers largely composed of immigrants and women of color. The FLSA exemption meant that employers were not required to pay domestic workers minimum wage or compensate them for working overtime. The D.C. Circuit Court decision sweeps domestic workers under FLSA—and thereby formalizes the work of a sector that has been historically overlooked.

The Home Care Rule went back into effect on November 12, 2015. Between now and December 31, 2015, the DOL is adopting a relaxed enforcement policy. In a policy statement, the DOL said that it will “exercise prosecutorial discretion” during this period. When making decisions as to whether to bring enforcement actions, the DOL will consider the extent to which States and other entities have “made good faith efforts to bring their home care programs into compliance” with the Home Care ruling. DOL will commence more rigorous enforcement in 2016.

The ease-in period buys more time as home health organizations and hospitals make adjustments. A common source of complaint and frustration is funding. Institutions funded by payers like Medicare and Medicaid are still at a loss as to how they will accommodate the overtime pay mandates into their budgets. In the first industry-led report since the D.C. Circuit Court decision, several membership associations released a set of recommendations outlining potential next-steps for home health providers. The report cautioned states from reacting adversely, such as prohibiting all overtime hours. It also suggested that home health institutions work with state legislators to make more room in their state budgets for home health aide payments.

The D.C. Circuit Court decision is clearly a win for labor rights activities and domestic workers. But with budgetary challenges and a potential Supreme Court appeal on the line, whether and to what extent the Home Care rule will be enforced remain to be seen.

This October the Johns Hopkins Bloomberg School of Public Health released a study linking fracking to adverse pregnancy outcomes, specifically premature births. Fracking, also known as hydraulic fracturing, is the “process of pumping chemical-laced water into shale to extract the oil or gas embedded within.” Fracking is a stimulation process used to access natural gas located 5,000-8,000 feet below the surface that was previously unavailable.

The study found that living within the most active area of fracking (most active quartile of drilling and production) activity was associated with a 40% increase in a woman giving birth prematurely (preterm is considered to be before 37 weeks gestation) and a 30% increase that an obstetrician had labeled their pregnancy high-risk. Of the pregnancies in the study 11% of those resulted in a premature birth with 79% of those preterm births taking place between 32 and 36 weeks.

Premature birth is a serious public health problem because it increases the risk of death and serious disability for children who are born prematurely. Children born prematurely may suffer from numerous health complications including breathing problems, feeding difficulties, cerebral palsy, developmental delay, vision problems, and hearing impairment. Preterm birth is the greatest contributor to infant death and the leading cause of long-term neurological disabilities in children. In 2010, preterm-related deaths accounted for 35% of all infant deaths and in 2005 preterm births cost the U.S. healthcare system 26 billion dollars.

The practice of fracking is a controversial topic for many reasons including other public health dangers fracking might be related to and the potential long-term environmental impact it might have. Preliminary studies conducted on births in Pennsylvania report an increased risk for low birth weight, which can be a sign of developmental problems. A Yale University study found that people living near natural gas wells are more than twice as likely to have respiratory illnesses and skin problems. There is also preliminary research suggesting that fracking is related to water pollution.

Additionally, fracking is a public health concern because its use and prevalence has rapidly expanded in the United States when much is still unknown about the dangers and long-term effects. The process of fracking dates back as early as the 1940s, while large scale use did not occur until 2003. It was around 2003 that “energy companies began actively expanding natural gas exploration with an emphasis in shale formations in Texas, Pennsylvania, West Virginia, Wyoming, Utah and Maryland.” Specifically, the expansion was supported by an EPA study released in 2004 announcing that fracturing posed no risk to the underground water supply. Shortly afterwards in 2005, fracking was exempted from the Safe Water Drinking Act in the Energy Policy Act of 2005 by the Bush administration. Fracking began in just a couple of states, but the practice has rapidly expanded and is now used in over fifteen states.

Although this study is not definitive, it shows that there are some public health risks associated with fracking and that more studies are needed. It is also a sign that the fracking industry should proceed with caution. Because fracking has relatively recently gained widespread usage, much is still unknown about the environmental consequences and the public health dangers fracking might cause.

Planned Parenthood Foundation provides easily accessible and affordable birth control, preventive health care measures, including breast and cervical cancer screenings, and medically safe and legal abortions resulting in vast improvements to the health of millions of women and children. The controversies surrounding Planned Parenthood does not negate the evidence that women, men, children, and families have reaped great benefits to their health since the Supreme Court’s decision in Roe v. Wade.

The Center for Medical Progress, an anti-abortion group based in California, released eight videos alleging Planned Parenthood violated federal law; first, selling fetal organs and tissues and, second, manipulating abortion procedures to procure intact fetuses. This conservative, anti-abortion group hired actors to go undercover as pro-choice, record and interview Dr. Deborah Nucatola, Senior Director of Medical Services at Planned Parenthood Foundation. David Daleiden led this manipulative deceitful attack as another attempt to terminate the foundation’s federal funding.

The Partial-Birth Abortion Ban Act of 2003 prohibits partial-birth abortions procured by intact dilation and extraction, (“intact D&E”). Under this law, 18 U.S.C. §1531,”Any physician who, in or affecting interstate or foreign commerce, knowingly performs a partial-birth abortion and thereby kills a human fetus shall be fined under this title or imprisoned not more than 2 years, or both.” In the Supreme Court decision of Gonzales v. Carhart, Justice Kennedy wrote the majority opinion upholding the Partial-Ban Abortion Act solely when the physician intends to perform an intact D&E, not the more common partial-birth abortion.

Differences exist between the more common partial-birth procedure known as dilation and evacuation and the illegal intact dilation and extraction method. The former first ensures fetal death has occurred before beginning the surgical abortion procedure. Whereas, the latter, “the person performing the abortion deliberately and intentionally vaginally delivers a living fetus until, in the case of a head-first presentation, the entire fetal head is outside the body of the mother, or, in the case of breech presentation, any part of the fetal trunk past the navel is outside the body of the mother.”

Congress’s intention behind the Act is that no partial-birth abortion exists that is medically necessary and consequently cannot put the safety of a mother first. However, the Supreme Court in Gonzales v. Carhart, only upheld the Partial-Ban Act solely to intact dilation and extraction and, furthermore, left open the possibility of an as-applied challenge if rendered medically necessary.

The paramount goal of an abortion is safety and care for the mother and her health. Mr. Daleiden alleges that Planned Parenthood is performing illegal partial-birth abortions. In one of the videos, Dr. Nucatola explains their success in receiving fetal organ tissue because the doctors perform abortions by using ultrasounds to ascertain the best location to grab the fetus with forceps. Any diversion of an abortion procedure for the purpose of gaining organ research is extremely unethical and it would defeat the primary purpose of the foundation providing safe, legal abortions.

Mr. Daleiden also alleges, “Planned Parenthood’s criminal conspiracy to make money off of aborted baby parts.” It is against federal law to sell fetal tissue. The foundation claims it makes no profit, but rather, the actual costs, including the cost to transport tissue to research centers, are reimbursed, which is standard across the medical field. Dawn Lagues, Planned Parenthood Executive Vice President, stated, “this was always about one thing – honoring the desire of women to contribute to lifesaving research. It was never about money.” Participating in this not-for-profit research is a voluntary and legal way to contribute towards creating successful vaccinations for diseases including Parkinson’s, polio, rubella, and chicken pox.

Irrespective of Planned Parenthood’s letter to Congress that proves the videos are heavily edited and inaccurate, the foundation announced they no longer will accept legal reimbursements from research in hopes to end another political anti-abortion attack.

Federal funding is imperative to Planned Parenthood providing women access to preventive care, life-saving screenings, and family planning services. While Federal funding is prohibited from paying for any abortions, these anti-abortion attacks on such an honorable and respected foundation will have devastating impacts. Restricting woman’s right to access medically safe, legal abortions and accessible preventive health screenings jeopardizes the health of women, their families, and our nation.