Author Archives: admin

Zika Virus: Global Emergency?

By: Karina Velez

Zika virus is a mosquito-borne disease currently spreading throughout Central and South America. Since March 2014, 14 countries and territories of the Americas reported cases of Zika infection. People with Zika infection usually suffer from fever, skin rash, muscle and joint pain, malaise, headache, and conjunctivitis. These symptoms usually last less than one week and are mild. Four out of five people with Zika virus have no symptoms, according to the World Health Organization (WHO). Most cases of Zika infection require no specific treatment, but a growing concern is the effect of Zika virus on pregnant women and their newborn babies. In November 2015, the Ministry of Health of Brazil noted a marked increase in microcephaly (in which the head circumference of newborns is smaller than expected) that coincided with Zika virus circulation in the country. Zika virus is affecting multiple counties in Latin America. The number of Zika cases among travelers visiting or returning to the United States will likely increase and the virus is expected to spread to North America. Currently, affected regions are advising women to avoid getting pregnant due to the link to birth defects. Additionally, pregnant women are being advised not to travel to affected areas. Experts say that Zika may rise to the level of a global threat because there is no vaccine or treatment available.

Preventative measures that people in affected areas can take include avoiding mosquito bites by using Environmental Protection Agency (EPA)-registered insect repellant (which are all evaluated for effectiveness); wearing long-sleeved shirts and long pants; staying in places with air conditioning or that use window and door screens to keep mosquitoes outside; and sleeping under a mosquito bed net. In the upcoming weeks, WHO and other organizations will monitor the development of the virus. WHO is concerned that this year’s El Nino could cause the virus to spread further through an increase in mosquito populations. El Nino typically brings warmer temperatures and shifting precipitation patterns, creating ideal breeding conditions for mosquito populations to thrive in. Reduction of standing water is necessary to interrupt the mosquito breeding patterns.

WHO could declare a global emergency when it meets on Monday, Feb 1st 2016. If WHO makes such a declaration, it will essentially be issuing a “a global Amber Alert for public health,” as stated by Susan Kim, a deputy director of Georgetown University’s O’Neill Institute for National and Global Health Law in Washington. This declaration will shine a light on the virus and generate a worldwide response. This is a sensitive matter for WHO because it has only issued global emergencies during three other health endemics: the H1N1 swine flu in 2009, the Ebola outbreak in 2014, and the reappearance of polio in Syria and other countries in 2014. WHO officials want to make sure that nations don’t take inappropriate steps to limit travel or trade because of the virus, said Bruce Aylward, assistant director-general of the WHO. Nonetheless, a strong response erring on the side of precaution is necessary because this virus is an inchoate infection and we have very little knowledge about it. Individuals are being exposed to it and they have no immunity to the infection and therefore more unknown affects and symptoms may arise and cause a serious pandemic.

Leave a Comment

Filed under Uncategorized

Depression Screenings During and After Pregnancy

By: Alexandra McLeod

Recently, an influential government appointed panel solicited by Human and Health Services (HHS) gave screening for postpartum depression during and after pregnancy a “B” rating in the Journal of the American Medical Association.  This new rating, if accepted, means that the Affordable Care Act would have to cover the screening of mothers during and after pregnancy for depression. As research has developed about this issue it has been found that postpartum depression can occur during pregnancy and if left untreated the mood disorder can negatively impact the child. Some individuals are curious as to why depression may occur in expectant mothers and the answer to that question is still unclear. The postpartum depression may stem from a mother not being able to bond with her child during or after birth or it is sometimes found to be genetic. In more recent years, research demonstrated more mothers suffer from postpartum depression after giving birth to their children. It is said that one of every seven mothers experiences the feeling of depression and only more recently have these mothers felt comfortable to talk to their doctors about these concerns.

Several healthcare providers (ex: obstetricians) have said that women have fears of hurting their children or themselves or concerns about the child’s welfare that is out of the mother’s control. This leads to mothers sometimes not being proactive with their prenatal health and if continued to go untreated a mother’s mental illness could affect the child’s well being. Previously, doctors were concerned with the risks of treating depression during pregnancy through a low dose or medication or screening because of the impact the protocols may have on the baby. However, as a result of growth within the medical field there is greater access to mental health facilities, safer ways to screen mothers for depression, and lower dosage anti-depressant medication that mothers can take that do not negatively impact the baby. It is important that women take advantage of these services to allow every mother the opportunity to play an active and positive role in her child’s life. Mayor Bill de Blasio of New York announced a goal to include universal screenings in women’s routine care.

While there is a large push to enact legislation for depression screenings during and after pregnancy the panel did not request a certain number of screenings for the expectant mothers during pregnancy and after birth to ensure that all mothers are receiving the proper care. The number of screenings can be determined upon future research and doctors’ opinions on the subject matter to protect their patients. This type of legislation is important because of the increasing number of expectant mothers that seem to be experiencing racing or suicidal thoughts. There is not better way to protect these women than being proactive and making sure the care that expectant mothers need is provided for these women through the new Affordable Care Act. A strong and loving motherly influence is important in a child’s life and the new depression screening guidelines will help make this possible.

Leave a Comment

Filed under Uncategorized

Congratulations to our new Fall 2015 staffers!

HLPB New Members Fall 2015

Leave a Comment

Filed under Uncategorized

Health Law & Policy Brief 2015-2016 Applications

Health Law & Policy Brief 2015-2016 Applications

The Health Law & Policy Brief (HLPB) is accepting applications for new members! We encourage 1Ls, 2Ls, 3Ls, and LLMs to apply.

The Health Law & Policy Brief covers a broad range of topics including: health care, food & drug, disability law, administrative law, and business law; both domestic and internationally. HLPB is entirely online. We publish long academic articles by students, professors, and practitioners. We plan to have two issues in the coming year – a Fall 2015 issue and a Spring 2016 issue. HLPB also has a blog component, which features short pieces on new and developing topics. The blog​ ​is located at​ ​http://www.healthlawpolicy.org/ ​and​ ​is updated every month.

We are primarily seeking multiple staff members to “spade” (edit) our academic articles. If selected as a staff member, you will receive training and advance notice before getting a spading assignment. You will be supervised by a more experienced Articles Editor. You will not receive more than one spading assignment per semester.​ ​We are also seeking one Marketing Director​.​

To apply, please email the HLPB Editor-in-Chief, Mohammad Mesbahi, at mohammadh.mesbahi@gmail.com with the​ ​​​subject line “LAST NAME – HLPB Application.”​ ​​Please briefly explain your interest in joining the HLPB, and if applicable, any interest or prior experience in health law, food and drug law, or disability law. Please also attach a current resume (GPA not required).
​​
Application deadline: Friday, October 2, 2015 at 11:59am (noon). ​​ We look forward to receiving your application!

​​Applicants who are selected ​to become members of HLPB ​should try to attend the HLPB Spading and Blogging Training on Saturday, October 3, 2015 from 1:00 PM – 4:00 PM in WCL Room 526.​ ​Those who cannot attend would be expected to notify the HLPB Editor-in-Chief and will be allowed to meet at a later time with the HLPB Editor-in-Chief.​ ​ Those attending this meeting should bring a laptop and their Bluebook.

Leave a Comment

Filed under Uncategorized

Supreme Court Declines To Hear Appeal Challenging the Independent Payment Advisory Board

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 (9th 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.

Leave a Comment

Filed under Uncategorized