Health Law and Policy Commons^™

Keynote Address, Recent Fda Hct/P Guidance: Help Or Hindrance?, Mary Ann Chirba

Mary Ann Chirba

The Aca, The Supreme Court And The Race For The White House: Does Anyone Understand Health Care Finance And Delivery?, Mary Ann Chirba

Mary Ann Chirba

The Aca: Where Did It Come From And Where Is It Going?, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

King V. Burwell - The Supreme Court Upholds Federal Subsidies For State And Federal Health Insurance Exchanges, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

King V. Burwell: Reflections On The Long And Bumpy Road To Aca Implementation, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Fda Regulation Of Adult Stem Cell Therapies As Used In Sports Medicine, Mary Ann Chirba, Berkly Sweetapple, Charles P. Hannon, John A. Anderson

Mary Ann Chirba

In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its “Human Cells, Tissues, and Cellular and Tissue-Based Products” regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented …

Regulatory Updates To Health Care Reform: Law And Practice, Mary Ann Chirba, Alice Noble, Michael Maddigan

Mary Ann Chirba

No abstract provided.

Panelist, The Contraceptive Mandate, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Moderator, "New Regulatory Models Ensuring Safety And Accelerating Treatments", Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Health Care Reform: Law And Practice, Mary Ann Chirba, Alice Noble, Michael Maddigan

Mary Ann Chirba

On March 23, 2010, President Obama signed comprehensive health reform, the Patient Protection and Affordable Care Act (PPACA) and commonly referred to as "Obamacare" or the Affordable Care Act (ACA), into law. With the passage of the ACA, Congress put an end to the century-long quest to secure coverage for all Americans facing steadily rising costs for increasingly sophisticated health care. In closing the book on that struggle, however, the law opened another. Health Care Reform: Law and Practice is designed to assist health care and legal professionals who need to understand what the law says, how it works, and …

Evolving Global Regulation Of Adult Stem Cell Therapies And Technologies, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

The Aca’S Tobacco Use Rating: Implementation, Inconsistencies And Ironies, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

As the Affordable Care Act continues toward full implementation, the law’s complexity is on full display. As we have noted in earlier writings, the ACA continues the federal tradition of using a fragmented approach to allocating oversight responsibilities among federal and state regulators, while maintaining the role of private actors in health care insurance and delivery systems. The result is a dizzying array of plan types (self-insured, fully insured, small market, individual market, large market, grandfathered) subject to an equally dizzying blend of ACA, ERISA, and individual state requirements.

Erisa Preemption Of State “Play Or Pay” Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba

Mary Ann Chirba

From the introduction: Although ERISA preemption was ranked among the top "eight pertinent issues" that needed to be addressed in order to achieve comprehensive health care reform, Congress opted to avoid it when it passed the Patient Protection and Affordable Health Care Act on March 23, 2010, and the Health Care and Education Reconciliation Act just one week later ("PPACA" or the "Act", collectively). Currently 180 million Americans receive employer-sponsored health benefits, and millions more will do so once PPACA takes full effect over the next few years. This expansion of employer based coverage, coupled with what the Act does …

Medical Malpractice, The Affordable Care Act And State Provider Shield Laws: More Myth Than Necessity?, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, …

The Supreme Court On The Affordable Care Act: What We Are Waiting For, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

From the introduction: With the U.S. Supreme Court poised to rule on the Affordable Care Act (ACA) it is worth reminding ourselves of what, exactly, we have been waiting for. We await a judicial opinion that could deliver a decisive blow to all or part of a massive piece of legislation and the hard-fought battles that led to its enactment, or salvage the near-century-old quest for health care reform. At the same time we await an opinion that may reshape our fundamental understanding of the Court, the power of Congress, and long-standing principles of federalism.

The Supreme Court Upholds The Individual Mandate: But Who Are We Talking About?, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

From the introduction: While the Affordable Care Act’s individual mandate survived constitutional scrutiny in NFIB v. Sebelius, a Republican president and/or changes in the House or Senate this fall could lead to its demise. As campaigns shift into high gear, the law’s opponents will undoubtedly draw on the strident and jointly authored dissent of Justices Scalia, Kennedy, Thomas, and Alito. Despite the value of robust debate, relying on the dissent may be problematic due to its misperceptions about the ACA and the realities of health care. Thus, while we considered what we were waiting for in the weeks before the …

Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated …

A Decade’S Quest For Safer Drugs: Congressional Committee Green Lights Regulation Of Drug Supply Chains And Compounding Manufacturers, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died …

In Search Of Regulatory Consistency: The Role Of Ivf Regulations In Improving Fda Oversight Of Autologous Stem Cell Therapies, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Regulation Vs. The Practice Of Medicine, Mary Ann Chirba

Mary Ann Chirba

Professor Chirba presented on the impact of federal and cross-border regulation on the development and delivery of adult stem cell therapies and other emerging forms of regenerative medicine. She also participated on a panel of researchers and clinicians to discuss practical strategies for attaining regulatory reform.

Individual And Group Coverage Under The Aca: More Patches To The Federal-State Crazy Quilt, Mary Ann Chirba

Mary Ann Chirba

From the introduction: Throughout the 2012 Presidential campaign, Republican contenders criticized the Affordable Care Act (ACA) as a “federal take-over of health care” for its promotion of national uniformity in health coverage and access. Yet long before passage, the architects of the ACA quickly rejected a federal single payor system, or even a federal public plan to complement the private sector plans due to forceful opposition to national reform. Instead, they traveled the only politically viable road to reform: maintaining the fragmented and complex system of health care coverage, where federal and state governments as well as the private sector …

Challenges In Teaching Legal Analysis: When Courts & Facts Collide: Scotus, Obamacare’S Individual Mandate, & “Facts”, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Panelist, Adult Adipose Stem Cell Therapies: Advances And Challenges, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Adult Stem Cell Therapies: Regulatory Pathways, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

The Supreme Court And Election Year Politics: Myths Vs. Reality In The Healthcare Debate, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

A Healthy Debate – The Affordable Care Act And The State Of Healthcare In America, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Physician Reimbursement And Other Payment Reforms Under The Affordable Care Act, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Drawing Lines In Shifting Sands: The U.S. Supreme Court's Mixed Messages On Erisa Preemption Imperil Health Care Reform, Mary Ann Chirba

Mary Ann Chirba

This article explains how and why the U.S. Supreme Court’s increasingly erratic preemption jurisprudence has fueled a health care system that routinely harms patients, frustrates health care providers, and derails state reform efforts. It begins by describing the mechanics of ERISA preemption, and then analyzes the Court’s 30 year odyssey from no preemption of state law claims against managed care payers, to broad preemption, retreating to limited preemption and, for now at least, trending again toward broad preemption. This is an extremely unstable area of the law which, at this point, demands not just an update but a thorough overview. …

An Uncertain Risk And An Uncertain Future: Assessing The Legal Implications Of Mercury Amalgram Fillings., Mary Ann Chirba-Martin, Carolyn M. Welshhans

Mary Ann Chirba

Trying to buy a mercury thermometer at the local pharmacy these days will result in a deluge of information regarding the risks of mercury and the proper disposal protocol for mercury thermometers as hazardous waste. Yet, inquiring about the risks of placing mercury in one’s mouth, in the form of a dental filling, is likely to meet with resounding assurances of safety from the dental profession. While such comforting disclaimers are meant to ease patient concerns, many continue to worry about the safety of dental mercury. This article will begin by describing the many safety concerns that surround the use …

Life Is A Highway: Severability Of The Affordable Care Act, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

No abstract provided.