Category: Blog

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.

On Monday, March 30, GNC reached an agreement with the New York Attorney General requiring testing standards for their “Herbal Plus” supplements that exceed current Food and Drug Administration (FDA) requirements. This agreement comes almost two months after the NY Attorney General sent letters to GNC, Walmart, Walgreens, and Target for allegedly selling store brand herbal supplements with ingredients that could not be verified or ingredients that were not listed on the labels.

GNC has been fighting lawsuits that have resulted from the New York Attorney General’s announcement because the company believes the lawsuits to be “without merit.” Despite this, GNC reached the agreement with the New York Attorney General to give its consumers “even greater confidence” in its products.

Under the agreement, GNC will perform DNA barcode testing on all “active” plant ingredients listed on labels, and will test for contamination with allergens before and after production. GNC will also make these tests standard procedure before placing their products on any of their stores nationwide. Furthermore, the company will introduce new policies over the next 18 months and submit semi-annual safety reports to the New York Attorney General’s office. The agreement confirms that GNC’s products are in full compliance the FDA’s Current Good Manufacturing Practices. Finally, the agreement recognizes GNC’s full cooperation with the attorney general. As a result of its updated testing, GNC has restored its “Herbal Plus” products to its shelves.

This move is a major shift in the lightly-regulated market for herbal supplements. The herbal supplement industry is estimated to be worth $60 billion worldwide. However, herbal supplements are not subject to the same level of scrutiny as drugs are by the FDA.

The New York Attorney General’s actions have not only caused GNC to pay attention, but have caused other Attorney Generals to take note as well. In fact, on April 2, a group of 14 state Attorneys General asked the U.S. Congress to investigate the herbal supplements industry. The Attorneys General sent their letter to Kansas Senator Jerry Moran and Pennsylvania Representative Joe Pitts, chairmen of subcommittees on product safety and health. The Attorneys General asked the subcommittees to work with the FDA to determine whether the agency should develop enhanced quality assurance programs and other safety requirements. The attorneys general stated “we believe the safety and efficacy of these supplements is a matter of deep public concern across the country,” and they urged “swift action.”

While industry officials and others say the industry is already sufficiently regulated on a federal level, it is time to re-think federal regulation of herbal supplements. Consumers have a right to know what they are purchasing and putting in their bodies. Most importantly, consumers deserve to know that the claims on these products are validated and that these products are safe.

On March 4, 2015, the Supreme Court participated in a divided and heated argument addressing the issue of whether the Internal Revenue Service (IRS) may permissibly promulgate regulations to extend tax-credit subsidies to coverage purchased through exchanges established by the federal government under Section 1321 of the Patient Protection and Affordable Care Act.

The Affordable Care Act (ACA) is also known as Obamacare, which is a law enacted to ensure access to affordable health insurance for all Americans. To achieve this, Obamacare offers consumer discounts, or tax credits, on government-sponsored health insurance plans by expanding Medicaid to include more consumers who cannot afford health care. To receive discounts, one’s household income must be between one and four times the Federal Poverty Level, a government regulated number used to determine the minimum amount of money needed for basic living expenses. These credits can be applied to premiums to lower monthly insurance bills or they can be declared on tax returns at the end of the year. For individuals whose income does not fall within that range, the option to purchase a plan on the federal insurance marketplace or through state exchanges is still available, but he or she will not get any discounts.

King v. Burwell, the case addressing this issue, centers on the language of the ACA. The statute approved federal subsidies to help Americans purchase health insurance on state exchanges. Instead of setting up their own exchanges, some states permitted the federal government to do so for their residents. Conservatives, contesting Obamacare, argue that those states are now being illegally subsidized, because the statute’s language specifically applies to state exchanges. Liberals, supporting Obamacare, argue that the law contains a typo regarding this provision, and the subsidies should continue.

After eighty minutes of controversial debate at the Supreme Court, it seemed that Obamacare’s future could depend on what was conveyed to the states when the Act was passed, whether tax credits could be offered in state and federal exchanges, or only in state exchanges. Under the first interpretation, the statute survives. Under the second interpretation, the law could still survive if the Supreme Court judges find that interpretation unconstitutionally coercive.

The plaintiff, challenger of Obamacare, argued that the issue rests on statutory interpretation, and the statute’s language does not include federal exchanges in its provision addressing the application of tax credits. The Supreme Court’s liberal wing responded by asserting that they do not just look at a few words, but the whole text to provide context. Justice Scalia then responded that the law “means what it says” even if that generates negative consequences.

Justice Kennedy, whose vote may decide the case, acknowledges that the plain reading of the statute may support the argument that tax subsidies are only permissible in state exchanges, but that that interpretation may be unconstitutional. Suggesting that the statute may be ambiguous enough to give the IRS deference to allow tax credits in federal health exchanges, Kennedy also recognized that authorizing the IRS that power might be a “drastic step” since billions of dollars is at risk.

Perhaps the statute should be expanded to include federal exchanges because the purpose of Obamacare is to make health insurance more affordable for those less fortunate. By refusing to incorporate federal exchanges, many citizens will not be able to participate in tax credits only because their state decided not to set up its own exchanges. However, if federal exchanges are included, the government may not be able to afford to offer everyone tax credits. The court’s decision is expected by late June, and will decide whether seven million low and middle-income people in around forty states will continue to receive discounts to aid them in affording health insurance. If the Supreme Court rules that the subsidies in federal exchanges were not authorized by the Act, most of those people will no longer be able to purchase health insurance, which could cause insurance markets in those states to downfall.

On January 20, 2015, in his State of the Union Address, President Obama launched a new Precision Medicine Initiative. This research initiative is a bold new effort to improve how we treat disease and how we cure diseases like cancer and diabetes. The Precision Medicine Initiative will pioneer a new model of patient-powered research that aims to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients. Personalized medicine is often described as providing “the right patient with the right drug at the right dose at the right time.”

Currently, medical practitioners follow a trial-and-error approach when treating patients. In other words, if a patient has a disease, his or her doctor will prescribe a treatment plan based on general information, and re-assess after a few weeks. If the treatment is not working, the doctor will change some variable in the plan, and wait a few more weeks to see if there is any improvement. This approach can lead to patient dissatisfaction, adverse drug responses and interactions, and poor adherence to treatment regimens by the patient. While this may seem bleak, there have been rapid developments in a variety of medical fields like genomics, medical imaging, and computational biology that are making it possible for scientists and doctors to personalize diagnosis and treatment of diseases. Precision medicine gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective. I believe the Precision Medicine Initiative is just what is needed to continue encouraging creative approaches to precision medicine and build the evidence base necessary to guide clinical practices.

The main objectives of this initiative are:

• An increase in better cancer treatments: The National Cancer Institute (NCI) will accelerate the design and testing of effective, tailored treatments for cancer by expanding genetically based clinical cancer trials, exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network,” that will generate and share new knowledge to fuel scientific discovery and guide treatment decisions.
• Creation of a voluntary national research cohort: The National Institute of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of one million or more Americans who volunteer to participate in research. Participants will be involved in the design of the initiative and will have the opportunity to contribute diverse sources of data – including (but not limited to) medical records, profiles of patient genes, chemical makeup, and environmental and lifestyle data.
• Commitment to protecting privacy: The White House will launch a multi-stakeholder process with Health and Human Services (HHS) and other Federal agencies to solicit input from patient groups, bioethicists, privacy and civil liberties advocates, technologists, and other experts to identify and address any legal and technical issues related to the privacy and security of patient data.
• Regulatory modernization: The Initiative will review the current regulatory landscape and work with the Food and Drug Administration (FDA) to determine whether changes are needed to support the development of this new research and care model.
• Public-private partnerships: The Obama Administration will forge strong partnerships with existing research cohorts, patient groups, and the private sector to develop the infrastructure that will be needed to expand cancer genomics, and to launch a voluntary million-person cohort.

Key Investments to Launch the Precision Medicine Initiative:

1. $130 million to NIH
2. $70 million to NCI
3. $10 million to FDA
4. $5 million to The Office of the National Coordinator for Health Information Technology (ONC)

In sum, the Precision Medicine Initiative is a great endeavor and its greatest benefits will likely be seen many years in the future. However, this initiative will revolutionize the practice of medicine, and give patients a better chance at good health than they have ever had.

 

On February 3, the New York State Attorney General’s Office accused four major retailers of selling fraudulent and potentially dangerous herbal supplements, demanding that they cease the sale of these products. Law enforcement officials investigated herbal supplements sold at GNC, Target, Walgreens and Wal-Mart. The investigation found that four out of five products tested did not contain any of the herbs on their labels. The pills only contained cheap fillers like powdered rice, asparagus, and houseplants. In some cases, the supplements consisted of common allergens, such as wheat-products.

Health experts welcomed the investigation, having long complained about the quality and safety of dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) of 1994 exempts substances from the requirements to demonstrate safety and effectiveness and from the Food and Drug Administration’s (FDA) pre-market approval. In contrast, the European Union regulates dietary supplements and requires a demonstration of safety before they can be sold. On the other hand, the FDA strictly regulates pharmaceuticals. Under 21 U.S.C. § 355, a provision of the Federal Food, Drug, and Cosmetic Act, the FDA requires that new drugs demonstrate safety and effectiveness through scientific evidence before receiving market approval.

In the past, the FDA has issued warning letters to manufacturers of dangerous supplements requiring them to either change the recipe of their supplement or remove their product from the market. In the majority of these cases, the FDA has received several reports of adverse events from consumers. For example, in November 2014, the FDA issued a warning letter to V26 Slimming Coffee because it contained sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons. Consumers may look at the FDA’s Consumer Updates web site for updates on recalls and alerts. However, this move by the New York State Attorney General’s Office is the first time a law enforcement agency has threatened the biggest retail and drugstore chains with legal action for selling “deliberately misleading herbal products.”

Some of the investigation’s findings at these retailers included:

1. Walgreens: store brand of ginseng pills contained only powdered garlic and rice;
2. Walmart: ginkgo biloba contained no ginkgo biloba, but radish, wheat, rice, and mustard;
3. Target: six herbal products tested negative for the herbs on their labels but did contain powdered rice, beans, peas and wild carrots; and,
4. GNC: pills contained unlisted ingredients used as fillers like powdered peanuts and soybeans.

Regulating supplements has been hotly debated in Congress. Senator Orrin Hatch (R-UT), the sponsor of DSHEA, has successfully opposed potential amendments that would require supplement makers to register their products with the FDA. In 2013, Senators Richard Blumenthal (D-CT) and Richard Durbin (D-IL) introduced the Dietary Supplement Labeling Act, which would require dietary supplement manufacturers to register their products with the FDA and to disclose known risks of any ingredients on their labels. However, this bill remains in the Committee on Health, Education, Labor, and Pensions (HELP).

Industry representatives dispute the testing methods used in the investigation, arguing that only a handful of fringe companies have caused these problems. However, New York’s investigations targeted store generic brands at national drugstores and retail giants, suggesting that these problems are pervasive and extensive. Dr. Pieter Cohen, an assistant professor at Harvard Medical School and an expert on supplement safety, stated, “If this data is accurate, then it is an unbelievably devastating indictment of the industry.”

Currently, tests are being conducted to confirm the results of New York’s investigation. Until the results are released, the debate continues. Consumers should be wary that the supplements they are taking may not contain the ingredient listed on their labels. James Hamblin, a physician and senior editor at The Atlantic, notes that even if these supplements do not contain their listed ingredients, there may be a legitimate placebo effect to taking these supplements. However, it is better for the public to know what’s in their supplements, rather than letting this “apparent institutionalized fraud” continue. Consumers have a right to know what is in their products, what they are putting in their bodies, and what they are spending their money on. The Dietary Supplement Labeling Act is a commendable step in the right direction, and the Senate HELP Committee should move it forward.