Category: Blog

In July 2015, the FDA proposed a rule that would update the Nutrition facts label on most food packages to include more information about how much added sugar is in a food product and what the appropriate consumption levels are. Added sugars are sugars and syrups that are added to food or beverages when they are processed or prepared.  Major sources of added sugar include soft drinks, sugars, candy, cakes, cookies, pies and fruit drinks; dairy desserts and milk products (ice cream, sweetened yogurt and sweetened milk); and other grains.

The proposed rule will require declaration of the “percent daily value” for added sugars. Presently, it is recommended that daily calories from added sugars not exceed 10 percent of a 2000-calorie diet. In a 2000-calorie-a-day diet, that works out to a daily maximum of about 200 calories a day or 12 teaspoons of added sugar. Currently, added sugar is presented in grams on nutrition fact labels. One gram of sugar contains about 4 calories. http://www.npr.org/sections/thesalt/2015/07/24/425908798/no-more-hidden-sugar-fda-proposes-new-label-rule

Food companies throughout the United States add sweeteners to their products, which increases calories but provides no nutritional value. Also, consuming too much added sugar leads to weight gain, obesity, Type 2 diabetes, and reduced heart health, and heart disease. Most Americans consume way more sugar than they realize. Sugar is one of the few major food components that doesn’t have a recommended consumption level on U.S. food labels, primarily because FDA hasn’t issued recommended consumption levels. This action by FDA will promote consumer awareness and allow Americans to make informed decisions relating to their sugar intake.

“For the past decade, consumers have been advised to reduce their intake of added sugars, and the proposed percent daily value for added sugars on the Nutrition Facts label is intended to help consumers follow that advice,” wrote Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, in an agency news release.

Currently, the FDA is taking comment on the new proposal for 75 days. Many health activists and consumer advocate groups have applauded the FDA’s efforts to inform consumers about how much added sugar they are actually consuming when they consumer processed foods and beverages. The agency will probably also hear from food companies. The Sugar Association has already weighed in, probing whether the move to constrain added sugars to no more than 10 percent of daily calories is backed by sufficient scientific evidence and studies. Moreover, food companies argue that nutrition fact labels do not influence most consumers and it will be expensive for companies to implement into their products.

This proposed rule is a part of a major overhaul by the Obama administration to modernize nutrition fact labels and inform consumers so they may lead healthier lives.

 

Written by Karina Velez–Fellow Health Law and Policy Brief Junior Blogger

There is a new wave of medicine that has been sweeping across the healthcare world. Telemedicine (also known as “remote healthcare”) is the new modern wave of healthcare. Telemedicine is the use of medical information exchanged from a single site to another via electronic communications to improve a patient’s clinical health status. The original purpose of telemedicine was to extend healthcare’s reach to rural areas to allow patients from these areas to be provided access to healthcare benefits. The technology that has become available after forty years of development now extends to services using two-way video calling, smart phones, and other wireless tools to provide services to the rural population in the United States. Since telemedicine creation the original purpose has expanded to include a variety of resources to both rural and urban patients in addition to the medical community. First, telemedicine provides primary care for those individuals in rural areas that may otherwise not have access to healthcare. Second there is the ability for doctor’s to monitor those patients who live remotely and need to have blood pressure or glucose levels checked on a regular basis. Third, the telemedicine field allows consumers to obtain specialized medical information, have access to discussion groups on health diagnoses, and provides peer support groups in times of need. Finally, telehealth is giving the medical field a makeover in how it shares information because doctors are now able to access more techniques and services through these devices to grow his or her technique in a particular field of study.

There are significant benefits from the expansion of telemedicine; healthcare can now be provided to a wider range of individuals, telemedicine is more cost efficient, improved the quality that as a nation we provide, and lastly there is more patient’s want to use telemedicine because it reduces the stress and time a person has to dedicate to ensuring his or her body is in good health.

As a result of the increase in patients and doctors alike wanting to use telemedicine, Congress would like to restructure how Medicare pays for telehealth. The representatives in support of this idea have proposed the Medicare Telehealth Parity Act of 2015. The act consists of three phases that are to be implemented over a four year period expanding the coverage of telemedicine not only to the members of the rural community but also to urban areas. Phase 1 consists of expanding the rural health centers and adding centers to metropolitan areas with a population less than a 50,000; this phase also includes the expansion of specialists such as diabetes educators and speech therapists. Phase 2 encompasses expanding telehealth sites to include metropolitan areas with populations of 50,000 to 100,000 people. The third and final phase of Congress’ plan is to then extend the telemedicine services to all geographic locations regardless of population size.

Bipartisan members of Congress that support the expansion of telecommunication have tried to introduce legislation that reimburses those companies that support telehealth endeavors. Unfortunately, in both 2013 and 2014 the bills did not leave the House Energy and Commerce Subcommittee on health despite the support the bill received from the Telecommunications Industry Association and American Telemedicine Association. The representatives are now hoping that the bill will get the chance to leave the Committee and that members of the healthcare community will sponsor this bill in order to have healthcare be available to every individual that needs it. This bill is legislation that would allow medicine to be provided to a larger demographic and ultimately benefit society by having healthcare be provided a little closer to home.

While June has undoubtedly been a groundbreaking month for the LGBT community with the Obergefell v. Hodges marriage equality decision, May was an important month as well. In May, the FDA followed through on its promise to reevaluate its current stance on blood donation from men who have sex with other men (MSM) by issuing a draft guidance proposing a 12 month deferral period. The draft guidance bars male donors who have “a history in the past 12 months of sex with another man.” The public will have 60 days to comment on the draft guidance and the FDA will ultimately issue a final guidance after reviewing the comments.

Currently, the FDA imposes a lifetime blood donation ban on “men who have had sex with other men (MSM), at any time since 1977.” he MSM rule was implemented in 1983 at the beginning of the AIDS crisis when the spread of the disease through transfusion was first recognized. The ban was initially created to be an outright ban on gay and bisexual men; however, in 1992 the FDA changed to its current policy to shift the focus from excluding whole populations it believes to be risky to excluding individuals engaging in risky behavior.

While it is FDA policy to limit donors based on risky behavior, the end result of the policy is an essential ban on gay and bisexual men.  If the risky behavior the MSM rule is trying to prevent is unprotected anal sex, then the guidance should not be directed exclusively at men who have sex with men. Women have anal sex, unprotected sex, and unprotected anal sex.

Both the current rule and the proposed guidance, perpetuate the stereotype that “gay sex, particularly anal sex, is deviant, disgusting, and diseased.” The rule also highlights the stereotype that if women engage in anal sex, it is an isolated, discreet, and accidental incident and also enforces the stereotype that heterosexual couples having unprotected sex are in a committed and monogamous relationship. But unprotected sex is seen as routine practice for those who identify as gay or bisexual because it is not possible for them to engage in a healthy, committed, and monogamous relationship since their sexual orientation by nature means they are sexually deviant.

Although a change from a lifetime ban to a 12 month deferral is progress, does it really go far enough? The new guidance will allow for a possibility of gay and bisexual men to donate, but the rule still stigmatizes them as a group. Many human rights and advocacy groups criticize the 12 month deferral for being too long because current tests can detect HIV as early as nine to eleven days after exposure.

The draft guidance also attempts to clarify the FDA’s policy on transgender donors. The note reads, “In the context of the donor history questionnaire, male or female gender is taken to be self-identified and self-reported. In instances where a donor has asserted a change in gender identification, medical directors may exercise discretion with regard to donor eligibility.” The FDA has been silent regarding transgender donors, as no official rule or draft guidance has been issued. As a result, blood donation and plasma centers have been left to create their own policy that has ultimately become a complete ban on transgender donors because blood banks and plasma centers view it as the simplest policy. Currently, there are multiple lawsuits around the country against blood and plasma donation centers for discrimination against transgender individuals. A transgender woman in Minnesota, Lisa Scott, is suing a CSL plasma center after being turned away. In Kent, Washington, Jasmine Kaiser is also pursuing legal action against CSL plasma center for being turned away because she was born biologically male.

Although the proposed guidance is a step in the right direction that will allow some gay and bisexual men to donate, the guidance is extremely lacking in its response to transgender donors.  The guidance is also only one step among many steps that should be taken to ensure equality in the way we screen blood donors. Until the FDA abolishes the MSM rule completely and creates proper policies to address transgender donors, discrimination against the LGBT community will continue.

In March 2014, the largest Ebola epidemic in history broke out in West Africa. It rapidly spread over the region, killing over 10,000 individuals since being declared an international public health concern in August. While projections suggest that the epidemic will end during 2015, there is still a desperate need for a vaccine. Results from a pre-clinical study of an Ebola vaccine out of the University of Texas Medical Branch in Galveston are showing promising results after all three infected monkeys, which received the vaccine, recovered within 28 days with just a single dose. More recently, the World Health Organization (WHO) declared Liberia Ebola-free after 42 days of no new cases. Still, the WHO warns against complacency.

While the latest developments are encouraging, public distrust of vaccines, along with misinformation about Ebola and inadequate healthcare infrastructure, have led to the need for a different approach for moving forward post-Ebola and addressing future outbreaks. Ebola has certainly served as a wake-up call for the potential global disaster of a similar outbreak in the future, but it is easy to see that the world needs a better global response system for outbreaks. The WHO, which has a Global Outbreak Alert and Response Network, is currently under both an internal and external review for its Ebola response. The organization is also working to implement reforms in light of the failures of this response; however, whether this will be enough for a future outbreak remains unseen. Some have suggested that the answer may lie, not only in the innovative technological and biomedical advances developing in light of this disaster, but in building trust in our global health systems. Others have suggested that this epidemic exposed a divide between the objectives of global health officials and the reality of infectious disease control, which needs addressing in order to better react to similar situations in the future. While Ebola is unique in its lethality, when a contagious virus meets health care systems undermined by internal conflict and chronic poverty, it is a short jump from rural villages to crowded cities.

Unlike previous Ebola outbreaks, which were contained quickly, the scale of the latest Ebola epidemic demonstrated deep, fundamental flaws with the health systems of affected states. Institutional weakness of the affected countries led to overwhelmed (rudimentary) health systems and, when paired with clearly ill-equipped and slow to respond multilateral institutions, a problem with our international response system is displayed. Critics worldwide have placed the blame on the WHO, using it as a global scapegoat. In its defense, the agency may have been set up to fail from the start, its lackluster performance more a reflection of the unreasonable expectations placed on it[1], especially when considered in light of the modest resources at its discretion. If the global health system expects the WHO to cope with similar global public health emergencies then it must empower it to respond to transnational health threats. Better still, the world may potentially be improved by addressing the underlying deficiencies in the multilateral framework infrastructure. Incorporating health into post-conflict reconstruction could be the key to preventing another rapid spread of Ebola or a future outbreak of the same degree (or, god forbid, one of greater magnitude.) Similarly, the development of, and the continued support of, a global health fund or contingency fund for the WHO would empower the global health system to react earlier and more efficiently to emergencies.

[1] Years of budget cuts and subsequent staff cuts weakened the WHO’s ability to respond in the magnitude required by the Ebola epidemic. While the WHO is responsible for responding to global health issues, decreasing financial contributions have arguably created unrealistic expectations given the world’s health needs.

By: Stuart I. Silverman, Esq.

On March 30, 2015, the U.S. Supreme Court declined to grant a writ of certiorari in an appeal of the Ninth Circuit’s decision in Nick Coons and Eric N. Novack, M.D. v. Jacob L. Lew, et al.,[i] rendered by the appellate court on August 7, 2014. The Ninth Circuit affirmed the lower court’s decision dismissing constitutional challenges to the individual mandate under the Patient Protection and Affordable Care Act (PPACA). The court of appeals also vacated the district court’s decision and remanded with instructions to dismiss a constitutional challenge brought against the Independent Payment Advisory Board (IPAB) enacted as part of PPACA. The Supreme Court denied certiorari, without explanation as is its usual practice.

Plaintiffs brought suit in the U.S. District Court for the District of Arizona, contending that the individual mandate enacted as part of the PPACA violated their constitutional rights to medical autonomy and informational privacy, asserting substantive due process protections under the U.S. Constitution. Plaintiff’s also sought a declaratory judgment that the Arizona Health Care Freedom Act was not preempted by the PPACA. That Arizona statute amended the State’s constitution, and made it lawful for individuals to decline to purchase health insurance without the payment of penalty for doing so. Lastly, in their complaint, plaintiffs argued that the IPAB was an impermissible delegation of legislative authority, and thus violated Article I. § 1 of the U.S. Constitution. The district court[ii] dismissed the counts pertaining to the substantive due process challenges, and also ruled that the Arizona Health care Freedom Act was preempted by PPACA. The lower court ruled on the plaintiffs’ challenge to the IPAB on the merits, concluding that the provision for the IPAB under the PPACA did not run afoul of the “anti-delegation doctrine” and thus, withstood scrutiny as a legitimate exercise of Congress’ legislative powers. The Ninth Circuit affirmed the district court’s judgment in favor or the defendants, except as it related to the court’s decision on the IPAB. Regarding plaintiffs’ count challenging the IPAB, the court of appeals concluded that the lower court lacked jurisdiction to hear the case.

The Independent Payment Advisory Board

The provision for the IPAB is codified at 42 U.S.C. § 1395kkk. By establishing the IPAB as part of the PPACA, Congress established an administrative board with the duties to monitor the growth of Medicare spending. The provision specifies a scheme with designated roles for government officials. If actual growth exceeds projected growth, then the IPAB is directed to develop recommendations to reduce the growth rate to meet the “savings target” set by the Chief Actuary of the Centers for Medicare & Medicaid Services.[iii] It is the duty of the Chief Actuary, in the first instance, to determination when the actual growth exceeds projected growth of Medicare spending. Where the Chief Actuary makes such determination, then the IPAB must make recommendations to reduce the rate of growth for a given year that the Secretary of Health and Human Services (“Secretary”) is mandated to put into effect in the absence of congressional veto. In the event that the IPAB does not make the required recommendations, then the Secretary must assume the responsibility to do so. Recommendations made by the IPAB under section 1395kkk are to be submitted to Congress and the President. In the event that the Secretary makes recommendations, then they are submitted to the President. The President must then submit them to Congress within two days. Section 1395kkk also provides for Congress to consider and vote on the recommendations, or enact superseding legislation. Where Congress does not enact superseding legislation, then the Secretary is bound to implement the recommendations submitted to Congress and the President.

The Challenge to the Independent Payment Advisory Board

In the lawsuit, plaintiffs mounted a facial constitutional challenge against the IPAB. They contended that the establishment of the IPAB under the PPACA violated the non-delegation principle under Article I § 1 of the U.S. Constitution. Article I § 1 reads: “All legislative Powers herein granted shall be vested in a Congress of the United States.”

The Ninth Circuit explained that it needed to first address whether the constitutional claims pressed by the plaintiffs satisfied the requirement of ripeness and plaintiffs’ standing to sue under Article III. The court of appeals viewed the analysis of ripeness and standing as “essentially the same.”[iv] On these points, the court of appeals determined that the court lacked jurisdiction to entertain plaintiffs’ challenge against the IPAB. One of the plaintiffs, Dr. Eric N. Novack, is a physician whose practice consists of Medicare patients for whom he receives reimbursement under that federal healthcare program. Dr. Novack argued that the authority vested in the IPAB, to make recommendations on Medicare reimbursement rates, will lead to financial harm against his interests. The Ninth Circuit was not convinced that the legal challenged pressed against the IPAB met the requirements of Article III. It was on that basis that the court of appeals found that there was no court jurisdiction to entertain the challenge against the IPAB. For Article III purpose, the court of appeals wrote that there needs to be an injury that is “concrete, particularized, and actual or imminent. . .   .”[v] The Ninth Circuit concluded that the alleged harm to Dr. Novack’s financial interests was simply too speculative, and too remote, to past scrutiny under the commands of Article III. It was observed that the challenge lodged against the IPAB was based on speculation about potential rate reductions “wholly contingent upon. . .unforeseeable events.” Additionally, citing 42 U.S.C. § 1395 kkk(c)(2)(A)(iii), the court of appeals observed that under the statutory scheme, the IPAB could not render a recommendation to reduce Medicare rates until after 2019.

Accordingly, district court’s judgment on the merits that upheld the IPAB as constitutionally permissible was vacated and remanded, with instructions to dismiss the court challenge for lack of court jurisdiction.

[i] 762 F.3d 891 (9^th Cir. 2014).

[ii] 2012 U.S. Dist. LEXIS 180306 (D. Ariz. Dec. 19, 2012)

[iii] The statute also directs the IPAB to consider, as part of its recommendations, other issues “to the extent feasible,” including, but not limited to, issues (i) to extend Medicare solvency; (ii) to improve delivery of health care via various models that would lead to enhanced efficiencies and health outcomes; and (iii) to protect and improve access to evidence-based items and services. 42 U.S.C. § 1395kkk(c)(2)(B).

[iv] 762 F.3d 891, 897.

[v] Id.

Biography of Stuart Silverman, Esq.

Stuart Silverman is an attorney with the Medicaid Fraud Control Unit in the District of Columbia Office of the Inspector General (OIG). He has been designated as a Special Assistant United States Attorney and a Special Assistant Attorney General for the District of Columbia. Mr. Silverman is also an Adjunct Professor with the Washington College of Law. Mr. Silverman has practiced health care law for most of his professional life. Prior to joining the OIG, Mr. Silverman was in private practice with Greenberg Traurig, and was also with the Office of the General Counsel for the U.S. Department of Health and Human Services (HHS). During his law firm association, Mr. Silverman provided counsel to health care clients on fraud and abuse, managed care, Medicare reimbursement as well as long term care issues. While with HHS, he represented the Health Care Financing Administration in federal court and before administrative tribunals on issues arising under the Medicare and Medicaid programs. Early in his career, Mr. Silverman was an attorney with the U.S. Environmental Protection Agency, and a Special Assistant United States Attorney for the Eastern District of Virginia.

Disclaimer

The views and opinions expressed herein by the author are his own, and cannot be attributed to the Office of the Inspector General for the District of Columbia Government.