This article was first published in the Los Angeles Daily Journal on December 16, 2013.
“Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.” — Sir Winston Leonard Spencer Churchill
The countdown to 2014 has begun. In the days to come, millions of Americans will choreograph exactly where to be at midnight on New Year’s Eve, full of resolutions and expectations for the coming year. This January 1 holds a special significance for our country, as the dropping of that massive 11,875-pound ball in New York City’s Times Square represents what many have for four years hoped to be the heralding of an epic transformation in our nation’s health care. Though unable to predict the future as in fairy tales of old, the descent of that Waterford crystal ball marks the coming of age of the Affordable Care Act, still shrouded in controversy and fighting for a foothold on which to support itself. Continue reading →
This article first appeared at Pharmaceutical Compliance Monitor on October 14, 2013.
“The more sand that has escaped from the hourglass of our life, the clearer we should see through it.” –Jean-Paul Sartre
When discussing the prospect of change to the structure of the American health care system, a little background is in order. Historically, the pharmaceutical industry has yielded to certain cyclical patterns that emerge when a new drug or treatment is introduced to the marketplace or new regulations come into effect, resulting in an initial surge followed in time by greater restraints imposed from both the federal and state level. Since its inception in 2010, the Affordable Care Act has in many ways preempted these cycles as it seeks to provide a nearly universal health care blanket by constructing a new foundation made of regulatory building blocks aimed at shifting emphasis from a cost based to a performance driven philosophy that it believes will reduce fraud and waste, thereby lowering costs across the board. Within its folds exist a number of pharmaceutical specific studies and programs designed to more accurately police the industry as the federal government attempts to curtail spending. With the emergence of the ACA, today’s pharmaceutical companies find themselves in an all too familiar situation, overlooking a vast new horizon of potentiality while beset by a host of new rules, where the prospect of greater market opportunity grapples with the restrictions that accompany increased regulation. Continue reading →
This article first appeared August 5, 2013, in the Daily Journal.
Friedrich Nietzsche wrote: “When we are tired, we are attacked by ideas we conquered long ago.”
More than three years deep into the Affordable Care Act, 13 months since the U.S. Supreme Court confirmed its constitutionality, and almost 10 months after the American public approved reform through the Electoral College, modern American health care is now poised to shine or make its claim as a historical disaster. As the nation prepares for the health insurance exchange, the next few months shall prove critical in determining the trajectory — and thus the fate — of our health care system, and we would be remiss not to notice the storm clouds forming overhead. Continue reading →
This article was first published at Pharmaceutical Compliance Monitor on July 17, 2013.
The world is full of obvious things which nobody by any chance ever observes.”
–Sir Arthur Conan Doyle
As the field of modern American healthcare continues to flex its newly grown muscles under the Affordable Care Act, the need for commitment to corporate integrity becomes ever more apparent. In a perfect world, the question of whether such leadership should come through an edict from the Federal Government or be provided as a matter of course within each individual company should not be a subject of debate, and yet recent failures on the part of of certain corporate giants within the health care community have forced the issue to the forefront, making those tasked with compliance ask the question “where does compliance begin?” The unnerving truth is that in today’s age of regulatory enforcement, the existence of an integrity agreement is little more than a necessary prerequisite, and its effectiveness suffers greatly as a result.
Most compliance officers agree that pharmaceutical companies should have a robust compliance program, yet at the same time, these same individuals may hold vastly different viewpoints about the infrastructure necessary to allow such programs to function in a corporate environment. With an eye on company revenues and private sector profits, pharmaceutical companies should never see a thoughtful and effective compliance program as simple counterbalance, though this is often the case. To do so may lead a company into the path of wary and watchful government regulators equipped with newfound investigative strengths. While not always a foregone conclusion, a pharmaceutical or biotechnological company would be wise to fear the impact of a mandated corporate integrity agreement (“CIA”), especially when it comes at the heels of a state or federal investigation. Continue reading →
The article was first published on June 24, 2013, at CorporateComplianceInsights.com.
“’What is the use of a book,’ thought Alice, ‘without pictures or conversations?’”
–Lewis Carroll, Alice in Wonderland
When it comes to federal regulations, there is an unfortunate dearth of illustrations. Instead, promulgation comes solely through the written word, as it did recently on the first business day in June 2013, when the Federal Register published volume 78, Number 108. Born from an act of Congress known as the “Federal Register Act” (49 Stat. 500-503 (July 26, 1935)), the Federal Register will be 78 years old this summer and boasts its own international standard serial number (ISSN 0097-6326). By its own admission, “[t]he Federal Register provides a uniform system for making available to the public regulations and legal notices issued by federal agencies. These include Presidential proclamations and Executive Orders, federal agency documents having general applicability and legal effect, documents required to be published by act of Congress, and other federal agency documents of public interest.”
The value of the Register is beyond measure. To be sure, regulatory transparency is a fundamental tenet upon which industry leaders must rely, and health care compliance professionals are certainly no exception. Continue reading →
This article first appeared in the 2012 Annual Review of the State Bar of California, Business Law News.
By 2014, the Affordable Care Act will rely heavily upon Medicaid as the program continues to evolve from its humble origins in 1965 to become part of the new foundation of a restructured American health care system. In the three short years since the passage of the Affordable Care Act, Medicaid has become the “dark horse” successor to Medicare in its attempt to reform a rapidly failing system while at the same time expanding health care to the nation’s estimated 50 million uninsured. Nearly five decades since its creation by an act of Congress, Medicaid is at last poised to steal the spotlight away from Medicare and change the course of modern American health care for decades to come. Continue reading →
This article was first published at Michigan Business Professional Association on April 30, 2013.
When it comes to health care, our nation has reached a crossroads. President Obama’s fledgling Affordable Care Act is a multifaceted, aggressive program designed to overhaul the delivery of health care by effectively restructuring its foundations from the inside out. In doing so, it seeks to reduce the number of uninsured patients who have for so long been a burden to a struggling health care system that must provide medical care as a service while also turning a profit as a business. But such a far-reaching plan has little chance of success if it is forced to evolve while fettered with the restrictions placed upon providers by certain grandfathered programs, most notably the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH). As a result, we as a nation must now consider whether the ACA’s fundamental mission or patient privacy should rule the day. Continue reading →
This presentation provides an overview of the Affordable Care Act three years after its passage. It explains how the landmark legislation evolved, what provisions are in place today, and what can we expect in the years to come. The implications for patients, providers and payers are massive, and this presentation is designed to provide a comprehensive overview for anyone interested to learn about health care reform.
A breakdown of Senate Bill 863 and what the new law means for devices used in complex spinal surgery.