Category: Blog

On September 2, 2016, the Food and Drug Administration (FDA) issued a press release on the safety and effectiveness of antibacterial soaps, calling for the removal of 19 active ingredients, including the much used triclosan and triclocarban, from over-the-counter antibacterial hand and body washes, determining that the risks of using these products outweigh their benefits. This is perhaps one of the Agency’s boldest steps yet toward fighting the phenomenon of antimicrobial resistant superbugs, an issue of increasing global frustration.

In its official final rule, issued in the Federal Register on September 6, the FDA noted that the investigation into the risk-benefit analysis of antiseptic began in 2013. “New information on potential risks posed by the use of certain consumer antiseptic washes prompted us to reevaluate the data needed for classifying consumer antiseptic wash active ingredients as generally recognized as effective (GRAE). As a result, we proposed that the risk from the use of a consumer antiseptic wash drug product must be balanced by a demonstration—through studies that demonstrate a direct clinical benefit (i.e., a reduction of infection)—that the product is superior to washing with [non-antibacterial] soap and water in reducing infection [].” As a result of considering recommendations from the public, evaluating available literature, data and comments, the FDA determined that “the data and information submitted for these active ingredients are insufficient to demonstrate that there is any additional benefit from the use of these active ingredients in consumer antiseptic wash products compared to [non-antibacterial] soap and water. Consequently, the available data do not support a GRAE determination for these consumer antiseptic wash active ingredients.” Likewise, with regard to safety, the FDA declared that “the available information and published data for the 19 active ingredients . . . are insufficient to establish the safety of long-term, daily repeated exposure to these active ingredients used in consumer wash products,” and thus could not be considered generally recognized as safe (GRAS).

“[W]e have no scientific evidence that [antibacterial washes] are any better than plain soap and water…In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).

This announcement comes at a time when the spread of antibiotic-resistant strains of bacteria, or superbugs, have proliferated, causing international concern. Antibiotic resistance occurs when bacteria evolve, becoming immune to what was used to treat the infections they cause. While a nature occurrence, it is believed that the widespread use of antibacterials, including soaps, exacerbate the problem.

Some bacterial infections once thought to be relatively benign, or at the very least curable, are having much more dire consequences. On July 26, 2016, professional football player Daniel Fells ended a short career with the NFL after contracting an antibiotic resistant strain of MRSA from a cortisone shot for an ankle injury. Further, in earlier this month, gonorrhea patients in Hawaii made up the first known US case cluster in which the sexually transmitted infection showed reduced susceptibility to the only available effective treatment option, the Centers for Disease Control and Prevention said, though their conditions were ultimately positively resolved.

On September 21, heads of state from across the globe convened at the United Nations General Assembly in New York, alongside experts in the field, for a one-day, high-level meeting to address the issue of antibacterial resistance. A rare occurrence, the UN has only met for public health issues three times before for reasons which included the HIV and Ebola pandemics. In a historic agreement, the U.N.’s declaration required nations to develop a two-year plan to protect themselves against antibiotics. After two years, the U.N.’s secretary-general would evaluate each country’s plan and monitor progress.

At this time, hand sanitizers, antibacterial wipes, and antiseptic products used in healthcare settings are not subject to the new regulation, though the FDA has called for additional research.

The effective date of this rule is September 06, 2017.

United States Marine Corps veteran Carri Leigh Goodwin reported that she was raped twice while on active duty with the Marine Corps in 2007. No one was prosecuted. Shortly thereafter, Goodwin received an “other than honorable discharge.” In 2009, Goodwin died of acute alcohol poisoning.

Last August, the New York Times published a letter written by Goodwin’s father, also a U.S. Marine Corps veteran, where he described his daughter’s military sexual trauma and the impediments to veterans who need health benefits but received the same military discharge as his daughter.

According to a report published by the Harvard Law School Veterans’ Legal Clinic, more than 125,000 veterans, including 33,000 who served in combat, were discharged as “other than honorable” after September 11, 2011 up to 2013. This constitutes about seven percent of veterans, the highest rate of such discharges since World War II. Other than being denied access to the GI Bill or Yellow Ribbon educational benefits and employment opportunities, an “other than honorable” discharge means being denied access to vital health care services.

As defined under 38 U.S. Code 1720D, military sexual trauma, [MST], is “psychological trauma, which in the judgment of a Veterans Administration (VA) mental health professional, resulted from a physical assault of a sexual nature, battery of a sexual nature, or sexual harassment which occurred while the Veteran was serving on active duty, active duty for training, or inactive duty training.” According to the VA’s national screening program, 1 in 4 women and 1 in 100 men admit that they have experienced MST. These figures only constitute veterans that have actually sought health care from the VA.

Other than post-traumatic stress disorder, other diagnoses can result from MST. These include depression, mood disorders, and substance use disorders. The Department of Veterans Affairs has also published a list of signs that can determine whether someone has suffered from MST, including worsening work performance.

The VA said that it is committed to ensuring that veterans get the health care they need. Among various services, every VA heath care facility has an MST coordinator and all treatment for physical and mental health conditions that resulted from MST are free of charge. Still, in order to have access to such health care, a veteran must have an “honorable” discharge. While reports of sexual assault in the military have risen by approximately 88 percent between 2007 and 2013, some victims allege that they have faced retaliation for speaking out, namely and most notoriously, by receiving “bad papers”- a “dishonorable” or “other than honorable” discharge.

“Bad papers” are correlated to high rates of suicide. According to former Air Force Chief Prosecutor Colonel Don Christensen, some traumatized service members may take a bad discharge just to escape their perpetrator or because they think it would be easy to upgrade the discharge to an “honorable” one later. Between 2009 and 2012, the Board for Correction of Naval Records, who would have been the final decision-maker in Goodwin’s case, granted just one percent of “other than honorable discharge” upgrade requests. In 2014, Defense Secretary Hagel issued a guideline for review boards to favorably consider discharge upgrade requests for veterans suffering from PTSD. There was no specific mention regarding veterans that suffered personality disorders or MST.

In May 2016, Human Rights Watch recommended that Congress require the Department of Defense to expedite the review of sexual assault cases of veterans who believe they received a wrong type of discharge, and to have greater transparency to the public regarding decisions on such cases.

As for Mr. Goodwin, he wants his daughter’s honor restored. He wants the military to acknowledge that his daughter was the only one that acted honorably by actually reporting her assault.

The Program of All-Inclusive Care for the Elderly, otherwise known as PACE, has a goal to keep America’s elderly living long and happy lives in the comfort of their own homes. To keep people out of costly nursing homes, PACE provides individualized care and services in the home, the community, and PACE centers. The focus of this program is on the participant and the care he or she needs.

The program began as an experiment in 1983, but 14 years later Congress authorized the program as a permanent part of the Centers for Medicare and Medicaid Services (CMS) in the Balanced Budget Act of 1997. To be eligible to join the program, one must be 55 years or older, live in the service area of a PACE organization, be certified by his or her state to need nursing home care, and be able to live safely in the community. Although state eligibility for nursing home care is a requirement to enroll in PACE, only about seven percent of PACE participants in the US reside in a nursing home.

Until recently, for-profit companies were not allowed to run programs like PACE; it was strictly for nonprofit groups. Critics of this aspect question whether or not for-profit companies are well-suited for this line of work considering that the business for caring for seniors is already tainted with abuse. However, according to a pilot study submitted by the Department of Health and Human Services in June 2015, the results showed no difference in quality of care and costs between nonprofit PACE providers and for-profit providers. The hope in expanding to for-profit companies is to encourage states to push for these programs and that these services will develop more rapidly.

There are now 34,000 older adults enrolled in PACE organizations in 31 states, and as of August 2016, the program will be getting its first major update in a decade. The Office of the Federal Register published a proposed rule on August 16, 2016. The proposed rule revises and updates requirements including: strengthening protections and improving care for recipients; and providing administrative flexibility and supervisory relief for PACE organizations. Under the former, the interdisciplinary team that is fundamental to the coordinated care participants receive will be able to participate more in other roles than the one role currently allowed. The hope is that this will assist in providing more efficient and individualized care to the PACE participants. In regards to the administrative flexibility, the proposal is more contemporary and simplified administration and operational rules to augment PACE organizations’ ability to do a number of things more easily, including a more automated application process to speed up and tailor services to participants. CMS believes these changes will make PACE regulations more consistent, transparent, and comprehensible, which leads to better care for all program participants.

As of 2015, there were 116 PACE programs operational throughout 32 states. Andy Slavitt, Acting Administrator for CMS, hopes to see this number continue to grow so that the US can continue to provide our aging population with the care they need and deserve.

Comments on the rule are due October 17, 2016.

Second Annual WCL National Health Law Writing Competition

American University Washington College of Law is pleased to announce its Second Annual National Health Law Writing Competition. This competition is designed to encourage law students to write scholarly papers on current topics of interest relevant to health law.

Cash prizes, sponsored by Corrine Propas Parver, WCL alumna, will be awarded as follows:

First Place: $1000 | Second Place: $500

Health law encompasses aspects of almost every area of law. Papers may address any area of the law as applied to the health care industry (e.g., antitrust, criminal, corporate, ERISA, among others) or areas of law unique to health care (e.g., fraud and abuse, reimbursement, privacy, access to health care, pharmaceutical/drug law, among others). Entries will be considered for publication in the WCL Health Law and Policy Brief.

Competition entries are due by November 30, 2016. Prize winners will be announced by February 28, 2017. Submissions must include an Official Entry Form and comply with all Competition Rules and Requirements. All questions should be directed to Professor Asha Scielzo at scielzo@wcl.american.edu. Please go to the following link to enter the competition: https://www.wcl.american.edu/health/writing/

 

LL.M. Health Law Specialization

Law and Government LL.M. students who are interested in health law and policy are eligible to earn a Health Law Specialization Certificate. The Specialization is a rigorous program designed to prepare lawyers for successful careers in the dynamic field of health law.

To fulfill the Specialization, students must complete a minimum of 12 credits from a list of approved courses and must write either two twenty to twenty-five page papers on health law topics or write one such paper and complete one externship in the field of health law. Students who specialize in health law are encouraged to complete Health Law (4 credits) and Administrative Law (3 credits), in addition to a selection of the wide range of specialized health law courses offered both during the academic year and in our innovative Health Law & Policy Summer Institute. Students meet regularly with the Associate Director of the Program on Law & Government and the Health Law & Policy Fellow to design a curriculum that meets their individualized needs and objectives and to ensure that they are on track to meet their goals.

Students specializing in Health Law are encouraged to earn academic credit through experiential learning. Washington, D.C. offers students a wide range of health law externships. These externships enable students to make valuable professional connections and to translate their classroom efforts into practical experience. The Program on Law and Government encourages LL.M. students to explore the many externship opportunities available in the nation’s capital and is committed to helping students find externships that are tailored to each student’s interests and goals.

In addition to regular academic year offerings, students are encouraged to participate in the Health Law & Policy Summer Institute. This flexible one-week program provides students and practitioners with training on a broad spectrum of cutting edge health law and policy topics. Custom-developed courses taught by prominent health lawyers from private practice, health care organizations, government, and nongovernmental organizations provide an intensive learning experience. Academic credits earned in the Health Law and Policy Summer Institute may be used toward the LL.M. Health Law Specialization.

For more information about Health Law & Policy at WCL, the LL.M. Health Law Specialization and/or the Health Law & Policy Summer Institute, please contact Health Law & Policy Fellow, Professor Asha Scielzo at scielzo@wcl.american.edu.

In the final weeks of summer, a new villain emerged in the eyes of many Americans- Mylan Pharmaceuticals.  Mylan Pharmaceutical Company raised the prices of the EpiPen to over $600 for a pack of two pens, a 400% increase since Mylan took on the project in 2007. The CEO of Mylan, Heather Bresch, had to explain to the nation why the steep hike in price was necessary. Bresch defended the increase, saying that it was mostly caused by the heavier use of high-deductible plans, which caused higher out of pocket costs, increasing the wholesale cost of EpiPen. However, this explanation did little to appease most EpiPen users, parents of children with severe allergies, or the American public at large, because it became obvious that much of the cost came from other factors that had nothing to do with the drug itself.

There were a number of factors other than high-deductible costs that the media and law-makers quickly pointed to as the reasons for the increase in EpiPen’s price. First, as the price of the EpiPen increased, so did the salaries of top executives at Mylan. Bresch earned just under $2.5 million when Mylan first acquired the EpiPen. Her salary is now $19 million, a 600% increase in the eight years since Mylan acquired the Epipen. Secondly, it became clear that the $600 price tag was not the result of production and other costs because, amid heavy criticism, Mylan offered a $300 generic alternative to the EpiPen. Finally, Mylan has quickly gained a monopoly over emergency auto-injectors when its only competitor Sanofi’s Auvi-Q recalled its entire supply last fall, leaving Mylan to increase the price without fear of consumers switching to another product. This dominance in the market has been the subject of a call by Senator Blumenthal (D-CT) and Senator Klobuchar (D-MN) for the FTC to investigate Mylan. While this extreme episode of drug pricing points to a number of more serious problems in the pharmaceutical world there is a more immediate question about how the FDA should react.

The FDA’s Mission is to protect the public’s health by ensuring the safety, efficiency, and security of human drugs. The FDA is also responsible for advancing public health by helping to speed innovations that make medicines more effective, safer, and more affordable. So the question becomes, in the face of price gauging, does the FDA have an obligation to accelerate generic drug applications? The FDA has worked since 2012 to reduce its 2,868 generic drug application backlog and has to some degree. The FDA approved 1,551 generic applications since 2012, but many applications have also been rejected for “major deficiencies”, a response received by Teva Pharmaceuticals. In March, the FDA rejected a generic version of the EpiPen created by Teva Pharmaceuticals. The FDA rejected the application due to “major deficiencies” in the application, which will delay the release of the drug until at least 2017.

However, accelerating drug applications more than FDA already has may be difficult if the agency does not have the money or personnel to evaluate the applications, which in the area of generic drugs has tripled in the last ten years. Additionally, the FDA has already made serious policy efforts to accelerate certain generic drug applications, particularly “sole-source” application vouchers. Sole-source generic drugs are those applications in which there is currently only one manufacturer on the market.  The FDA is making a concerted effort to get competition out onto the market, but as the FDA’s mission statement also requires it to approve safe and effective drugs.

Although accelerated applications can be beneficial to create more options for consumers, the FDA also has to be aware of safety consequences. This is exactly the argument made by Progressive think-tank, American Progress, who warns that faster drug approvals will only help pharmaceutical companies, not patients. The organization’s report on this issue, released last March, states “this approach would lead to additional drugs entering the market with little evidence to support safety and effectiveness.”  It also states that the FDA’s drug approval process is actually one of the fasted in the world, therefore putting the blame on FDA is a faulty argument.

It is clear there have been efforts by the FDA to get more competition out on the market, but it has to do so cautiously because availability isn’t the only concern. Also, it’s clear that even if backlogged applications are part of the drug pricing problem, it’s a small part. The FDA should continue to employ the methods it is already using to decrease its generic drug backlog. However, as more generic drug applications continue to come into the FDA, it should be careful not to bow to the pressure of the generic drug companies and politicians to lower safety standards in order to increase efficiency.

The False Claims Act (FCA), 31 U.S.C. §§ 3729-3733, was enacted during the time of the Civil War to combat  fraud committed by the suppliers of  goods to the Union army. What made the False Claims Act different from other fraud and abuse laws was the inclusion of the qui tam provision that allowed private citizens/whistleblowers (“relators”) to bring a lawsuit against companies and individuals who were defrauding the government. Over the years, the FCA has had many changes, but more recently, the FCA has become the primary tool in combatting federal healthcare fraud and abuse.

Healthcare spending is skyrocketing in United States. As of the recent data, published by the Center of Medicare and Medicaid services on December 3, 2015, health spending accounted for 17.5 percent of the nation’s Gross Domestic Product (GDP). In 2014, U.S. health care spending grew 5.3 percent, reaching $3.0 trillion. It is no surprise that, with this gargantuan amount of healthcare cost, there is a renewed attention to expose health care fraud and abuse. False certification is an archetypal example of fraud and abuse perpetrated by healthcare providers.

False certification is when hospitals, physicians, and healthcare providers misrepresent to government health care programs through non-compliance with all the regulations and obligations under their contracts with government. For example, when providers misrepresent non-covered treatments as medically necessary for the purpose of obtaining payments from federal healthcare program.  However, in legal terms there are two categories of certification: 1) express false certification and 2) implied false certification. Express false certification theory applies when a government payee, “falsely certifies compliance with a particular statute, regulation or contractual term, where compliance is a prerequisite to payment.” United States. ex rel. Conner v. Salina Reg’l Health Ctr., Inc., 543 F.3d 1211, 1217 (10th Cir. 2008). While express false certification may not seem too hard to understand on its face, circuit courts across the country have been split on the application of the implied certification theory of liability. Government and qui tam plaintiffs have argued that just submitting a claim for reimbursement alone implies compliance with federal rules, and the implied false certification theory can be a basis for liability. On the other hand, defense counsels have argued that implied certification creates an excessive burden on defendants, especially when defendants have to pay treble damages for noncompliance of a contractual or regulatory terms as conditions of payment.

On June 16, 2016, the  Supreme Court in Universal Health Services v. United States ex. rel. Escobar, 136 S. Ct. 1989 (2016) unanimously held that implied certification theory, can be a basis for FCA liability,  thus resolving a  circuit split. Under the Universal Healthcare decision, “when a defendant submitting a claim makes specific representations about the goods or services provided, but fails to disclose noncompliance with material statutory, regulatory, or contractual requirements that make those representations misleading with respect to those goods or services” 136 S. Ct. at 1994.

However, the Supreme Court limited the wide application of the implied certification theory. First, when government payee submits a claim for government payment, the claim must not “merely request payment,” but also makes “specific representation about the goods or services provides.” Second, the Supreme Court applied the common-law rule to misrepresentation, where “half-truth representations that state the truth . . . . while omitting critical qualifying information- can be actionable misrepresentation.” 136 S. Ct. at 1994. In a footnote, Justice Thomas gave examples of tort law, contract law and securities law to demonstrate the example of common law misrepresentation, which is very much the same in understanding misrepresentation in the FCA context. Third, the Supreme Court pronounced that the materiality standard is demanding. The Court further went on to state that when assessing materiality under FCA, it’s not dispositive that every violation of express condition of payment can trigger liability. Id. at 2003. The Supreme Court identified additional situations on what can trigger materiality, and in sum, it is dependent on specific context.

The much-anticipated Universal Health Services decision resolved the circuit split, and at the same time would thwart attempts by plaintiffs and the government to bring cases for a “garden variety of breaches of contract or regulatory violation.” Overall, this decision is a win for plaintiffs and government because a healthcare provider can still be facing implied certification liabilities under FCA for making a fraudulent claim for payment from the federal healthcare programs, but at the same time defense counsels have an assurance in light of this decision that minor regulatory and contract violations would not result in huge liabilities. Lower courts will determine what lies ahead in the wake of this decision, whether qui tam plaintiffs will have difficulty pleading facts sufficient to prove the test outlined by the Universal Health Services court or whether the defense community have these new guardrails to shield them from unsubstantiated implied false certification liability.