June 2013—CDC Public Health Law News
In this Edition
Journal article discussing federal legal preparedness tools. The Journal of Law, Medicine & Ethics published Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies, by Brooke Courtney, Susan Sherman, and Matthew Penn. Preparing for and responding to public health emergencies involving medical countermeasures (MCMs) often raise complex legal challenges and questions among response stakeholders at the local, state, and federal levels. In this article, lawyers from the U.S. Department of Health and Human Services' Office of the General Counsel, CDC, and Food and Drug Administration discuss federal legal tools that are critical to enhancing MCM legal preparedness for public health emergencies, with an emphasis on the legal mechanisms that can be used to facilitate the emergency use of countermeasures. Find more information about legal preparedness and read the journal article.
Laboratory Services Mapping Poster. Molly Berkery, legal fellow with CDC's Public Health Law Program, presented the LEI Policy Guide: A Resource on Interstate Laboratory Test Sharing at the 2013 Association of Public Health Laboratories Annual Meeting and Seventh Government Environmental Laboratory Conference. The poster represents one part of a two-part project that includes a legal mapping component and in-depth case studies of test sharing among selected state public health laboratories. Learn more about the Public Health Law Program at CDC and see the poster [PDF - 149KB].
CDC Public Health Law Program director to speak at NACCHO Annual Conference. Matthew Penn, director of the CDC Public Health Law Program, will co-present Good Decision-Making in Real Time: Practical Public Health Ethics for Local and State Health Officials at the NACCHO Annual conference on July 10, 2013. Mr. Penn is one of five experts hosting the workshop. The workshop will provide public health professionals with tools and practical examples to address ethical challenges that commonly arise in the practice of public health and will cover the relationship between public health law and ethics. Find more information about the workshop and the NACCHO Annual Conference.
Public Health Law Research opens 5th call for proposals. Public Health Law Research has released its fifth call for proposals. Approximately $1 million for short-term studies will be awarded under this call for proposals, with eighteen-month awards of up to $150,000 for each study. The program seeks to build the evidence for and strengthen the use of regulatory, legal, and policy solutions to improve public health and help people lead healthier lives. The deadline for submitting full proposals is July 24, 2013 (3 p.m. EST). Find more information about Public Health Law Research and proposal requirements.
Model Aquatic Health Code and National Environmental Health Aquatic Symposium. The first edition of the Model Aquatic Health Code will be released for final comment at the National Environmental Health Aquatic Symposium as a special preconference to the 2013 National Environmental Health Association Annual Educational Conference & Exhibition. The preconference will be held July 8 from 1 to 5 p.m. and is free with any one-day conference registration. The main conference will be held July 9–11 in the Washington, D.C. area. Contact Jill Schnipke at JSchnipke@neha.org to make a reservation for the preconference. Find more information and register for the main conference.
NALBOH Annual Conference. The National Association of Local Boards of Health (NALBOH) is hosting NALBOH 21st Annual Conference, Responsible Governance for a Brighter Public Health Future,which will take place August 14–16, 2013 in Salt Lake City, Utah. The conference will provide board of health members and other public health professionals with information on public health governance functions, engaging citizens, and the role of effective leadership in healthy communities. Find more information about NALBOH and the 21st Annual Conference.
'PHLR: Theory and Methods' now available. Public Health Law Research, a national program of the Robert Wood Johnson Foundation has published a new book, "Public Health Law Research: Theory and Methods." It explores the mechanisms, theories, and models central to public health law research. This new volume, edited by Scott Burris, J.D. and Alexander Wagenaar, Ph.D., describes the many ways laws can affect health. The book covers framing public health law research, understanding how law influences the environment and behavior, identifying and measuring legal variables, and designing public health law evaluations. Find more information about Public Health Law Research and the PHLR: Theory and Methods.
Community benefit state law profiles. The Hilltop Institute has released Community Benefit State Law Profiles (Profiles) which present a comprehensive analysis of each state's community benefit landscape as defined by its laws, regulations, tax exemptions, and, in some cases, policies and activities of state executive agencies. The Profiles organize these state-level legal frameworks by the major categories of federal community benefit requirements found in § 9007 of the Affordable Care Act (ACA), § 501(r) of the Internal Revenue Code. Find more information and access the Profiles.
New York Times (05/30/2013) Robert Pear
On May 30, 2013, the White House released Early Results: Competition, Choice, and Affordable Coverage in the Health Insurance Marketplace in 2014 [PDF - 200KB], a memorandum describing the three types of health care marketplaces available under the Patient Protection and Affordable Care Act (ACA) and how the individual state marketplaces appear to be opening states, which have historically been serviced by a handful of insurance service providers, to additional insurance providers.
Under the ACA, states may elect to fully run their own marketplace, have the Department of Health and Human Services (HHS) fully run their marketplace, or work with HHS to run their marketplace. In 2014 HHS will fully run 19 marketplaces, 17 states and the District of Columbia will fully run their own marketplace, and 15 states will run their marketplaces in conjunction with HHS.
The memorandum noted that of the states who have elected to have their marketplace run entirely by the federal government, about 75 percent will have at least one new insurance company entering the market. The memorandum further stated that "the majority of states will have new health insurance choices that are not available today" and that most consumers should be able to choose from five or more insurers' health plans.
"The individual insurance market is now up for grabs. Blue Cross plans will face a lot more competition. Many products sold in the insurance exchanges will have more limited networks and hospitals than has been the norm in the employer-based coverage. Consumers will receive federal subsidies based on their income, not the plans they choose. That creates a strong incentive for consumers to seek plans with lower premiums," said Paul B. Ginsburg, president of the nonpartisan Center for Studying Health System Change, of the new marketplaces and the initial data described by the memorandum.
While the initial data is still subject to later changes as the markets develop, such competition is expected to offer more choices for consumers, which could, in turn, encourage insurance companies to push down premium prices.
California: Justices question interests behind requirements for injections in school
Some justices question requiring nurses to give shots in schools
Los Angeles Times (05/29/2013) Maura Dolan
Colorado: Lawmakers struggle to define driving under the influence of marijuana
Redefining 'under the influence' in Colorado
New York Times (06/07/2013) Dan Frosch
Massachusetts: Boston schools policy: condoms, sexual education, and support
Boston schools might offer condoms
Boston Globe (06/08/2013) James Vaznis
Minnesota: New laws ensure trafficked children treated as victims, not criminals
Human rights expert's view: Trafficked children are victims, not criminals
Duluth News Tribune (06/09/2013) Robin Phillips
[Editor's note: Read Minnesota's No Wrong Door Model and child prostitution and Safe Harbor laws.]
Oklahoma: Mayor pushes for ordinance requiring tornado shelters in new homes
Mayor of tornado ravaged town says new law should be mandatory to keep people safe
Oregon: Farmers say FDA-proposed irrigation rules will preclude most surface water
Northwest onion growers sure FDA's proposed rules will sting
Mail Tribune (06/09/2013)
[Editor's note: Read the U.S. Department of Food and Drug Administration's proposed Food Safety Modernization Act rule regarding Standards for the Growing, Harvesting, Packing and holding of Produce for Human Consumption.]
National: Study finds some designated drivers over legal alcohol limit
Designated drivers often drink themselves
NBC12 (06/10/2013) Randy Dotinga
[Editor's note: Find more information and read the study, Breath Alcohol Concentrations of Designated Drivers, published in the July 2013 issue of the Journal of Studies on Alcohol and Drugs.]
National: Lawsuits and restraining orders lead to review of transplant rules
Second child waiting for lung transplant gets judge's reprieve
ABC News (06/08/2013) Sidney Lupkin
[Editor's note: Learn more about organ transplantation rules and the Organ Procurement and Transplantation Network.]
National: Employees eligible for lower premiums, regardless of health improvement
U.S. regulators issue rules on workplace wellness programs
Reuters (05/29/2013) Sharon Begley
[Editor's note: Find more information and read the final rules.]
Russia: Almost 40 percent of Russians smoke; new anti-smoking law could lower rates
Russia tries to kick habit with anti-smoking law
Yahoo! News (06/01/2013) Steve Gutterman
Feature Profile in Public Health Law
Judith Monroe, M.D.
Title: Director CDC Office Of State Tribal Local and Territorial Support (OSTLTS), Deputy Director, CDC
Education: B.A., Eastern Kentucky University; M.D., University of Maryland
Title: Senior Health Care Advisor to the Director of OSTLTS
Education: Master of Public Administration, University of Louisville; Bachelors degrees in Public Health and Nursing, Indiana University
CDC Public Health Law News (PHLN): What sparked your interest in public health?
Monroe: I didn't plan a career in public health, but when then Indiana Governor Mitch Daniels asked me to be the Indiana State Health Commissioner in 2005, I had to accept. I had practiced medicine for several years and became increasingly concerned about the number of patients with preventable diseases caused by environmental and behavioral factors beyond the walls of my office. I saw public health as the avenue to make a difference.
Staley: I've always been interested in helping people improve their health. I was working in clinical nursing for a number of years and then when I took an epidemiology class at the university, it suddenly dawned on me that I could help improve the health of entire populations of people by working in public health as opposed to few people at a time working in clinical care. Later my public health work evolved to policy as I believe it to be the most sustainable of the public health interventions.
PHLN: Please describe your respective career paths.
Monroe: I started my career as a medical technologist working in blood banking and then kidney transplant at Walter Reed Army Medical Center in Washington, D.C. Although I loved the laboratory and working at the cellular level, I soon learned that I liked working with people more, so I went to the University of Maryland for medical school.
Following my residency in family medicine at the University of Cincinnati, I served a four-year National Health Service Corps obligation in rural Tennessee practicing frontline medicine. From there I entered academia and served as the clinic director in the Department of Family Medicine at Indiana University and then residency program director for Family Medicine and director of the Primary Care Center at St. Vincent Hospital in Indianapolis before the governor called me to public service. After five years as state health commissioner, I took on the challenge of being a deputy director for CDC and directing the new Office of State, Tribal, Local and Territorial Support (OSTLTS).
Staley: As a registered nurse, my career started out working in clinical acute care for several years and began working as a case manager with the health insurance plans in managed care, then the Medicare and Medicaid programs for the state of Indiana. I completed my graduate education and worked for a time as a federal grant manager in local public health.
I started working for CDC in Atlanta in 2003, first in the National Center for Environmental Health and later in the Office of the Associate Director for Policy on implementation issues related to the Affordable Care Act. In 2013, I moved to OSTLTS to continue to work on Affordable Care Act issues; specifically on issues related to the intersection of health care delivery system and public health.
Today, my role is senior healthcare advisor to the director of OSTLTS, Dr. Judy Monroe. My work focuses on furthering the integration of state and local public health and the health care delivery system through partnership and policy development and training.
PHLN: Please describe your respective programs and your roles and responsibilities within your respective programs.
Monroe: As OSTLTS director, I provide leadership and guidance for supporting and revitalizing the public health system. Integral to that leadership is strengthening relationships and communication among CDC staff, health officials at all levels, public health partners, and broader health system stakeholders. OSTLTS' mission is to advance U.S. public health agency and system performance, capacity, agility, and resilience. OSTLTS focuses on improving health department capacity and performance; developing assessment and capacity building tools; and engaging state, tribal, local, and territorial health officials with CDC. OSTLTS is CDC's primary connection to health officials and leaders of state, tribal, local, and territorial public health agencies, as well as other government leaders who impact health departments at all levels.
The Institute of Medicine and others have identified that one way the health system needs to be improved is through greater connection and collaboration between public health and health care. Therefore, in 2012, OSTLTS developed the Primary Care and Public Health Initiative (PCPHI). Through this initiative CDC works with clinical educators to develop public health educational resources that can be delivered in residency training programs and to foster the relationship between residency programs and their health departments.
Staley: The CMS is an operational division of the US Health and Human Services (HHS) agency. The division provides the system for health care coverage for the elderly, disabled, and low-income adults, children, and women.
The CMMI was created under section 3021 of the Affordable Care Act [PDF - 200KB] to test innovations in health care delivery and financing. Most interestingly included in the legislation is the authority given to the HHS secretary to scale successful innovation nation-wide outside of the traditional rule-making process.
PHLN: How does CMMI's work relate to OSTLTS and CDC's Office for Prevention through Healthcare (OPTH)?
Stately: OSTLTS and OPTH provide technical assistance to CMMI in preventive services and defining population health. In addition, many innovations tested at the Center involve OSTLTS constituents, primarily state and local public health agencies, and linking the services they provide to the broader health care system.
PHLN: What are State Innovation Models (SIMs)?
Staley: Through its SIM Initiative, CMMI is providing $300 million to support cooperative agreements with twenty-five states through their governors' offices to develop, test, and implement SIMs. The SIMs Initiative is the funding mechanism for states to create SIMs. The purpose of the SIMs effort is to redesign the health care delivery and financing system, moving from an episodic, fee-for-service model to one that is more coordinated, value-based, and patient centered. SIMs are intended to be an all-payer approach, including Medicare, Medicaid, CHP, as well as commercial health insurance plans and other purchasers.
PHLN: How are the SIMs integrally related to public health law?
Staley: Because SIMs are intended to be innovative, SIM states will need to consider what laws and policies are already in place that support or enable the model, whether existing laws and policies need to be updated, or whether and what kinds of new laws or policies might be needed for the model to be implemented and successful. For example, the state is responsible for Medicaid program authorities and waivers, health provider and facility licensure, healthcare governance structures, and other legal aspects of the state health care delivery and financing mechanism, including healthcare budgeting. That is why the governors' offices were chosen to lead the efforts in individual states.
PHLN: Can you describe the three types of SIM awards that are currently funded?
Staley: There are three types of SIM awards: model design, model pre-testing, and model testing. CMMI funded twenty-five states in the first round of funding as follows:
Sixteen states—California, Connecticut, Delaware, Hawaii, Idaho, Illinois, Iowa, Maryland, Michigan, New Hampshire, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, and Utah—received funding to design a state innovation model within six months. The start date for all awards was April 1, 2013.
Three states—Colorado, New York, and Washington—received funding to pre-test their SIMs over six months. These three states had plans which were already near completion, but needed additional development.
Six states—Arkansas, Maine, Massachusetts, Minnesota, Oregon, and Vermont—received a three-year award to test their state innovation models.
PHLN: What are the SIMs' main goals?
Staley: A major goal of the SIM is for the states to move a preponderance of the health care delivered within the state from the episodic, fragmented, volume-based fee-for-service basis to a value-based system that rewards quality and health improvement.
PHLN: How are SIMs related to health care transformation and the integration of primary care and public health?
Staley: The SIMs provide additional knowledge for transforming the health system through design and testing of new models. The integration of primary care (now thought of more broadly as clinical care) and public health will support that transformation by incorporating the core functions of public health, namely, assessment, policy development, and assurance of population health into the health care delivery system.
PHLN: What is the "three-part aim" with regard to the SIMs?
Staley: The three-part aim developed by the Institute for Healthcare Improvement has been widely adopted as guiding principles for health system transformation. The three-part aim includes 1) better health care, i.e., improved quality of care; 2) better health, i.e., improved health outcomes, population health; and 3) lower costs, i.e., decreasing the costs of care with provision of "the right care at the right time in the right place."
While the SIMs have autonomy to create models that are unique to their individual needs, SIMs should be based, to some extent, on these goals.
PHLN: Do you expect any particular, themes, strategies, or community goals to be presented in the Innovation Models? If so, can you please give an example and describe how such a strategy could be implemented?
Staley: There are three major strategies evident in the current state transformation plans. The first involves the patient-centered medical home (PCMH). In this model, the patient is provided more comprehensive care that extends to services that take place outside the clinical setting. More responsibility is given to the provider to coordinate the care and the patient is more involved in developing his or her care plan. Many states are beginning to develop or expand PCMH models.
Second, Accountable Care Organizations are an increasingly used model. This is a business model where providers, including hospitals, enter into a financial risk arrangement based on the quality of care, health outcomes and cost of care for their assigned population.
Third, there are different coordinated care models being organized that involve assessing the health needs of the community, either locally or regionally, and in many cases, then coordinating and delivering the health care support community services in collaboration with the providers. I think these organizations offer great opportunity to achieve the three-part aim, and I think are where public health can integrate and be impactful in the health system transformation effort.
PHLN: What kind of legal strategies and considerations do you expect the SIMs grantees to grapple with?
Staley: Because Medicaid programs are governed in large part by state law, states may need to seek amendments to those enabling authorities. Depending on the scope of services to be offered under their SIMs, states may also need to seek Medicaid 1115 and other waivers as appropriate. Another legal consideration is whether states want to create whole new healthcare governance structures as was done in Oregon's coordinated care organizations. There are licensure issues with providers and facilities, and the roles and standards of care for non-physician providers, such as community health workers and nurse practitioners may need to be addressed. In addition, with the expansion of electronic health records and health information exchanges, data privacy concerns will need to be considered.
PHLN: How are OSTLTS and OPTH supporting and interacting with SIMs?
Staley: OSTLTS and OPTH work with other CDC Centers, Institutes and Offices (CIOs), particularly the National Center for Chronic Disease Prevention and Health Promotion, to support the SIMs. OPTH provides the overall policy leadership and direction; OSTLTS works with OPTH and other CDC CIOs, developing and coordinating comprehensive technical assistance. CDC is part of the CMMI SIM team and participates in meetings, calls, and webinars. CDC encourages understanding and appreciation of the important contributions public health brings to health care transformation efforts.
PHLN: How can individuals and healthcare professionals connect with the SIMs effort in their states and play a role in the state health system transformation and learn more about health system transformation, generally?
Staley: Stakeholders, individuals, and health professionals located in the SIM states can engage in the development or implementation of the SIM. Information can be obtained through the state's governor's office. The OSTLTS website, the "STLT Gateway," will include teleconferences and other information related to health system transformation.
PHLN: Do you have any hobbies you would care to share?
Monroe: As for hobbies, I'm trying to get back into oil painting. I thought in high school that I would pursue art, but my love of science and working with people won the day. I love to bike, hike, and kayak whenever possible, and gardening is a growing passion.
PHLN: Have you read any good books lately?
Staley: Yes, "Thomas Jefferson, The Art of Power," by Jon Meacham. I've read several Jefferson biographies and I'm always intrigued by his personal character (not perfect), but a great leader. I also, read, "If We Can Put a Man on the Moon: Getting Big Things Done in Government," by William Eggers and John O'Leary. Very apropos for thinking about what I believe to be the greatest challenge and thrill of my career: participating in the efforts to transform of the US health care delivery and financing system).
Monroe: I just read "Girl with a Pearl Earring" and "Home Front." Both are fiction but give insight into history, which I find enjoyable and insightful.
PHLN: Is there anything else you'd like to add?
Staley: It's an exciting time to be part of the US health system! This is huge! I'm glad this opportunity occurred during my career.
Iowa: Board of Nursing, Dep't of Public Health authority to change supervisory rules
Iowa Medical Society v. Iowa Board of Nursing [PDF - 260KB]
Supreme Court of Iowa
Case No. 11-1977
Opinion by Justice Thomas D. Waterman
South Carolina: Hospital employee who refused flu shot was not discharged for cause
AnMed Health v. South Carolina Dep't of Employment and Work Force [PDF - 56KB]
South Carolina Court of Appeals
Case No. 2013-207906
Opinion by Justice John C. Few
North Carolina: Dental Board violated antitrust law in ousting non-dentists
North Carolina State Board of Dental Examiners v. FTC [PDF - 81KB]
United States Court of Appeals, Fourth Circuit
Case No. 12-1172
Opinion by Judge Dennis W. Shedd
Federal: EEOC files and settles first genetic information discrimination lawsuit
EEOC v. Fabricut, Inc. [PDF - 267KB]
United States District Court for the Northern District of Oklahoma
Case No. 13-CV-248-CVE-PJC
Joint Motion for Entry of Agreed Consent Decree filed 05/07/2013
[Editor's note: Find more information about the lawsuit and genetic information discrimination.]
Federal: U.S. Supreme Court says genes are not patentable
Ass'n for Molecular Pathology v. Myriad Genetics, Inc.
Supreme Court of the United States
Case No. 12-398
Opinion by Justice Clarence Thomas
Quotation of the Month
Paul B. Ginsburg, president of the nonpartisan Center for Studying Health System Change
"The individual insurance market is now up for grabs. Blue Cross plans will face a lot more competition. Many products sold in the insurance exchanges will have more limited networks and hospitals than has been the norm in the employer-based coverage. Consumers will receive federal subsidies based on their income, not the plans they choose. That creates a strong incentive fore consumers to seek plans with lower premiums," said Paul B. Ginsburg, president of the nonpartisan Center for Studying Health System Change, of the new health marketplaces created under the ACA.
About Public Health Law News
The CDC Public Health Law News is published the third Thursday of each month except holidays, plus special issues when warranted. It is distributed only in electronic form and is free of charge.
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- Page last updated: June 19, 2013
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