The Struggle to Find a Home in the Affordable Care Act and a Place in History0
This article first appeared in the 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. … Read more →
PBS’s ‘This Emotional Life’: Eye on the Elderly: Helping Seniors in the Hospital Setting
This article was previously published on the Huffington Post.
“All diseases run into one, old age.”
–Ralph Waldo Emerson
Finding oneself in the hospital can be trying at any age. But for the elderly such an experience comes with a host of separate issues, both mental and physical, that need to be addressed in conjunction with prompt and professional care for their ailment. As our nation’s baby boomers begin to retire and medical advances increase life span, the average patient age continues to rise, a trend that appears to have no end in sight. In our efforts to assist an aging friend, relative or loved one, it is important to keep in mind that patience and perspective rule the day.
In this fast-paced modern age, when a young or middle-aged person gets sidelined through illness or accident, his or her thoughts often refer to the quotidian: school or work responsibilities, upcoming social events and family obligations. While the elderly entertain these thoughts as well, in many instances their priorities and focus will differ considerably. What may seem trivial to a 25-year-old may be of great importance to a patient of 85, be it paying the phone bill, watering the plants or feeding the cat. As a result, one of the most helpful things we can do when visiting sick, elderly patients is to ask them what they feel needs to be done. Through the simple act of listening, the caregiver or friend offers the understanding that the patient is not alone, and the needs of their life outside the hospital are being met. This frees them to focus their attention on the illness at hand and offsets the feelings of loneliness and helplessness that come with any hospital stay. … Read more →
Proceed With Caution: Matters to Consider for Business Lawyers Transitioning into Health Care0
This article first appeared in the NY Business Law Journal in November 2012.
When venturing into areas of law outside their usual practice, attorneys should be mindful of state-specific standards to which they are held. Rule 3-110 of the California Rules of Professional Conduct sets the standard on the west coast, just as Rule 1.1 of the New York Rules of Professional Conduct applies on the east. Absent the requisite skill to accommodate a client’s needs, an attorney may still engage and adhere to the statutory definition of competence by “associating with or, where appropriate, professionally consulting another lawyer reasonably believed to be competent” or “by acquiring sufficient learning and skill before performance is required.”[1] In 2003, a California Appellate Court explained: “Attorneys are expected ‘to possess knowledge of those plain and elementary principles of law which are commonly known by well informed attorneys, and to discover those additional rules of law which, although not commonly known, may readily be found by standard research techniques.’”[2]
However, due to the sheer volume and complexity of information generated regularly in the wake of reform, modern health care law exists in a league of its own. … Read more →
The Familiar Path of Health Care Reform0
This article first appeared in the Daily Journal on August 5, 2013.
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. … Read more →
Managing Integrity in Deed by Clarity of Word0
This article was first published in the 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 health care 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. … Read more →
Don’t Fear the Federal Register0
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. … Read more →
Roadblocks to Reform: The Influence of HIPAA and HITECH on the Affordable Care Act0
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. … Read more →
Taxing Health Care Reform0
Benjamin Franklin said: “In this world nothing can be said to be certain, except death and taxes.”
For almost 60 years, April 15 has meant “Tax Day,” or the day when individuals must submit their income tax returns to the Federal Government. The Sixteenth Amendment to the United States Constitution establishes Congressional “power to lay and collect taxes on incomes, from whatever source derived, without apportionment among the several States, and without regard to any census or enumeration.”
Three years since its passage, the Affordable Care Act (ACA) has become inextricably connected to the laws of federal taxation. The following overview explains some key points of intersection: … Read more →