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.

iStock_000023873789Small copyFriedrich 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 →

Medicaid Expansion: Tracing the True Value of a Free Lunch0

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. … 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 →

Navigating The Rapids of Health Care Reform Without a Paddle0

 This article first appeared in Corporate Compliance Insights on March 28, 2013.

“The only fence against the world is a thorough knowledge of it.”  – John Locke, philosopher (1632-1704)

In its bid to restructure the nation’s health care system, the 2010 Patient Protection and Affordable Care Act (the “ACA”) has created both challenges and opportunities in the areas of corporate compliance, governance and risk communities. In three short years, myriad regulatory clarifications have swollen this 906-page statutory giant into a 70,000-page behemoth whose might has been enough to overcome the judicial and electoral challenges of 2012, eliminating any doubts as to whether reform is here to stay.

At its core, the ACA means different things to different people. Patients typically focus on the promise of new guarantees and protections for health insurance for the populace, as well as the penalties for those who remain without coverage. But the ACA has also captured the attention of health care providers as they shift from a formerly cost-based system toward one that gauges success or failure primarily on patient experience. Even the insurance industry must yield to the new law and wend its way through a changing landscape complete with medical loss ratio requirements, the end of lifetime limitations, challenges to any increase in premiums over a certain percentage, and the soon to be introduced Health Insurance Exchanges.

While the infusion of elements such as innovation, preventative care and overall wellness provide the Federal Government with a new and as yet untested backup plan to ensure the success of health care reform, plenty of room still exists within the ACA to combat health care fraud, abuse and waste. The False Claims Act stands at the forefront in the government’s battle to preserve the integrity of health care resources, although the law has evolved considerably since first signed into effect by President Lincoln in 1863.  By ensuring the legacy of the FCA for future generations, however, the ACA has also created several compliance risks for companies across the nation.  Here are the top five: … Read more →

The Affordable Care Act: A Not-So-Little Train That Must0

This article was first published in the Los Angeles Daily Journal on February 25, 2013.

“Things do not change. We change.”  – Henry David Thoreau

Finally free from the uncertainty of looming elections or Supreme Court decisions questioning constitutionality, modern American health care can now be compared to a speeding train serving infinite destinations, with conductors and passengers alike learning the routes along the way. Public transportation is usually forgiving, as the tardy or confused passenger always has the opportunity to catch the next train, but such is not always true in matters of public health.  Whether fan or foe of the Affordable Care Act (the ACA), this epic codification of health care reform is something that America cannot afford to miss.

At the time the ACA was passed in March 2010, by a margin of seven of the collective 431 Congressional votes, few of those involved had any real working knowledge of the 10,909 sections contained within the Patient Protection and Affordable Care Act, which were quickly adjusted and finalized by congressional changes the following week in the form of the Health Care and Education Reconciliation Act. Weighing in at over 900 pages, hindsight makes it clear that the ACA was only the beginning of the federal government’s plan to restructure the nation’s health care system, a fact that has been compounded by an estimated 70,000 pages of further regulations in the three years since President Barack Obama signed the ACA into law. … Read more →