Return of the Hall Monitor0

Say Hello to the Chief Compliance Officer at a Pharmaceutical Company Near You

This article first appeared in Pharmaceutical Compliance Monitor on February 11, 2013.

As any teenager will tell you, nobody likes a snitch. When it comes to the antics of the adolescent, rarely is unwanted disclosure or unsolicited intervention met with appreciation.  And yet, in observing the conduct displayed recently throughout many fields in our nation’s business sector, similar sentiment rang true across corporate America, and the moral “high road” was rarely found to intersect with the path most traveled. The health care industry was no different, and any strict constructionist interpretation of the Hippocratic Oath usually limited “do no harm” to the delivery of patient care in its most literal sense, foregoing the machinations conspiring behind the scenes to keep a hospital’s doors open in the face of a souring economic climate.

Now Is the Time for Compliance

The ethical transformation in health care that gained momentum one score and seven years ago has its origins in a law signed on March 2, 1863, by the president famous for the words “four score and seven years ago” uttered that same year.  The False Claims Act (the “FCA”), also known as “Lincoln’s Law” and the “Informer’s Act,” has evolved considerably since its enactment to become the “primary litigative tool for combating fraud” (see S. Rep. 99-345, at 2 (1986)).  … Read more →

Administrative, Community, Health Care Law, Health Care Reform, Hospitals, News, Regulatory

Modern American Health Care (in 83 slides)1

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.

Administrative, Clinical, Health Care Law, Historical, Hospitals, News, Non Clinical, Regulatory

The Poor Get Poorer: The Fate of Distressed Hospitals Under the Affordable Care Act0

This article, written by Samuel R. Maizel and Craig Garner, first appeared at 2012 No. 12 Norton Bankr. L. Adviser 1 in December 2012. 

Synopsis

Distressed hospitals in America operate on small or non-existent profit margins.3 For many of those hospitals, the federal Medicare program and the individual States’ Medicaid programs are the largest payors. While the Patient Protection and Affordable Care Act of 2010 (the “Affordable Care Act”) was designed in part to increase the number of insured nationwide, the result of which should be positive for hospitals, any cause for celebration must first address the cost containment provisions in the Affordable Care Act that create new concerns for financially distressed hospitals. Included among the multitude of provisions in the Affordable Care Act are an immediate 1% cut in Medicare revenue, phased in reductions in disproportionate share payments to hospitals, future, permanent penalties of up to 1% of Medicare payments for hospitals which perform poorly under the Hospital Value Based Purchasing Program, and additional penalties for hospitals with unacceptable rates of re-admission or too many hospital acquired conditions rates.4 Together these cuts create a daunting challenge for the many financially distressed hospitals in America that simply lack the resources to establish an infrastructure designed to treat Medicare patients in this era of change.

Background

Medicare is the federal program that provides health care coverage to individuals aged 65 or older. Medicaid offers similar access for medical services on a state level for qualifying individuals, many of whom are poor. Medicaid covers 69 million people.5 By 2020, under the Affordable Care Act the number of Medicaid beneficiaries is likely to increase to 93 million.6 Combined, Medicare and Medicaid pay for more than half of the annual hospital bills in America. … Read more →

Clinical, Community, Health Care Law, Health Care Reform, Historical, Hospitals, News, Regulatory, Technology

A Lesson from the Sneetches0

This Practitioner Application to the article “Post Acute Care and Vertical Integration After the Patient Protection and Affordable Care Act” (by Patrick D. Shay and Stephen S. Mick) appeared in the January/February Edition (Volume 58, No. 1) of the Journal of Healthcare Management.

In his classic tale “The Sneetches,” Theodor Seuss Geisel (Dr. Seuss, 1961) created a society divided by entitlement in which the lines of separation were removed, thrusting its members together. A satire about discrimination, “The Sneetches” offers children an early introduction to the arbitrary walls that those forces governing society can build and destroy at their whim.

Shay and Mick may be said to describe a similar scenario as they apply provisions of the 2010 Affordable Care Act (ACA ) to post-acute care and vertical integration under the Medicare Shared Savings Program (also known as accountable care organizations or ACOs) and to bundled payment systems. They note that these are the areas in which the influences of the ACA are most apparent. In the process, Shay and Mick remind us that perception is formed largely on the basis of factors lurking beneath the surface that care little for public opinion. For example, much like Dr. Seuss’s Sneetches, Hurricane Sandy, which struck the East Coast shoreline in October 2012, rendered the “haves” and “have nots” almost indistinguishable. Bellevue Hospital, the oldest hospital operating in the United States, was capable of offering roughly as much care during and immediately following the hurricane as it was in 1736, when the New York City Almshouse designated six bedrooms as Bellevue’s first “ward.” … Read more →

Administrative, Children's Health, Clinical, Community, Health Care Law, Health Care Reform, Historical, Hospitals, News, Regulatory

Health Care Reform: Walking the Fine Line Between Epic and Tragic0

This article was first published at California Healthcare News on January 8, 2013.

The recent changes to the core structure of modern American health care are nothing short of epic, rivaled in historic scale only by the introduction of Medicare in 1965. Although each decade over the past 50 years has in some way used government programs and incentives in an attempt to urge health care to undergo recalibration as a means to establish industry stability, by the end of the first decade of the 21st Century it had become evident that health care in the United States was fast becoming unsustainable as it existed. Enter health care reform.

Three years after the Federal Government passed the Affordable Care Act in an attempt to right the sinking ship, we the people are still waiting for the tide to turn. Having survived last summer’s monumental challenge before the United States Supreme Court and a presidential election in November, the Affordable Care Act has not only emerged as the law of the land, it has cemented its place as health care’s blueprint throughout America for decades to come. For California, however, the timing is unjust, as the perfect storm brought about by fiscal cliff/debt ceiling concerns heads straight for Sacramento from the east just as health care’s versions of Scylla and Charybdis approach forebodingly from both north and south. … Read more →

Administrative, Clinical, Community, Health Care Law, Health Care Reform, Historical, Hospitals, News, Regulatory, Technology

The Evolving Relationships Between Hospital, Physician and Patient in Modern American Healthcare0

This article, written by Craig B. Garner and David A. McCabe, was first published in the Journal Health, Culture and Society, Vol. 3, No. 1, on November 16, 2012.

Introduction

Today’s healthcare climate is one of uncertainty, with the longstanding bond between doctor and patient growing ever more tenuous as the nation reacts to fundamental changes within its healthcare structure. Since March 2010, when President Obama signed into law the Patient Protection and Affordable Care Act[1] as amended by the Health Care and Education Reconciliation Act[2] (collectively referred to as the Affordable Care Act or “ACA”), the federal government has continued to release information aimed at clarifying and expanding upon the original 2,700 pages of codified reform. At its core, ACA seeks to prohibit health insurers from denying coverage or refusing claims based on pre-existing conditions, expand Medicaid eligibility, subsidize insurance premiums, provide incentives for businesses to offer healthcare benefits, and increase support for medical research.

As the implementation of these new programs, partnerships, preventative care measures, competitions and grants steals headlines daily, ACA’s ramifications underscore the ways in which the Federal government has increased its presence in healthcare in an effort to ensure that the allocated trillion dollars in federal funding remains accountable. Arguments made by both critics and supporters of ACA have become all too familiar in the ongoing debates, with each side citing the nation’s growing economic crisis as a major factor in ACA’s future.  … Read more →

Administrative, Clinical, Health Care Law, Health Care Reform, Historical, Hospitals, News, Regulatory

Redefining the Valuation Methods of Modern Day Hospital Care1

This article was first published in the New York State Bar Association’s Health Law Journal, Vol. 17, No. 3 (Summer/Fall 2012).

Due to the sensitive nature of the industry it services, the American hospital must rightfully operate under copious federal and state regulations, in addition to volumes of rules and ordinances established by separate, non-governmental entities. Though policing policies such as accreditation, certification and periodic review come from a variety of both public and private sources, the goal is generally consistent: develop uniform standards to ensure that hospitals in the U.S. operate at an acceptable safety level while delivering quality patient care.

The Many Paths to Accreditation

Though its primary function is without question the delivery of accurate and effective medical treatment, health care is also big business.[1] In an attempt to promote constant vigilance among America’s hospitals, any one institution may be subject to accreditation review at any time from private, non-governmental organizations such as the Joint Commission,[2] the Healthcare Facilities Accreditation Program (HFAP),[3] Accreditation Commission for Health Care (ACHC),[4] Community Health Accreditation Program (CHAP),[5] the Compliance Team, Inc.,[6] Healthcare Quality Association on Accreditation (HQAA),[7] or DNV Healthcare, Inc. (DNV),[8] among others.[9]

By and large, each private entity governs through its own set of rules.  For example, the Joint Commission surveys hospitals by following more than 276 standards and reviewing 1,612 elements of performance.  HFAP does largely the same thing pursuant to its 1,100 or more individual standards.  Focusing on home medical equipment as well as durable medical equipment, prosthetics, orthotics and supplies (“DMEPOS”), HQAA has developed a review process consistent with federal standards.[10] … Read more →

Administrative, Clinical, Community, Health Care Law, Historical, Hospitals, Miscellaneous, News, Regulatory, Surgery

The Supreme Court Opens the Road to Health Care Reform, But Will California Meet the Challenge?0

This article, by Craig B. Garner, Esq. and Julie A Simer, Esq., first appeared in the Business Law News of the State Bar of California (Issue 3 2012).

Almost 28 months after President Barack Obama signed the Affordable Care Act (“ACA”)[1] into law, the United States Supreme Court upheld the constitutionality of health care reform.[2]  Though the underlying arguments set forth in the 59-page majority slip opinion venture deep into the labyrinth of constitutional law and test the traditional boundaries of federalism, the holding itself is clear and concise: (1) the ACA’s individual mandate is constitutional;[3] and (2) the Medicaid expansion provisions found within the ACA survive, but the Federal Government is prohibited from penalizing “[s]tates that choose not to participate in [the Medicaid expansion] by taking away their existing Medicaid funding.”[4]   The decision promises to have a dramatic effect on California, as the country’s most populous state.

In ruling that the individual mandate is constitutional, the Court rejected the Commerce Clause[5] and the Necessary and Proper Clause[6] in the Constitution as bases for upholding the mandate. The Court held that the Commerce Clause failed to provide a sufficient nexus between the requirement to purchase health insurance and its anticipated effect on interstate commerce to validate the individual mandate:

No matter how “inherently integrated” health insurance and health care consumption may be, they are not the same thing: They involve different transactions, entered into at different times, with different providers.  And for most of those targeted by the mandate, significant health care needs will be years, or even decades, away.  The proximity and degree of connection between the mandate and the subsequent commercial activity is too lacking to justify an exception . . . .[7]

Chief Justice Roberts noted that the Commerce Clause does not give Congress the authority to compel an individual “to become active in commerce by purchasing a product, on the ground that … failure to do so affects interstate Commerce.” [8]  Likewise, the Court rejected the Necessary and Proper Clause as a means to sustain the individual mandate, finding it was not “an essential component of the insurance reforms.”[9] The Court distinguished previous decisions upholding laws under the Necessary and Proper Clause, because the laws at issue in those cases “involved exercises of authority derivative of, and in service to, a granted power.”   Whereas, the individual mandate would give Congress the ability to create the “necessary predicate to the exercise of an enumerated power.” The Court added:  “Even if the individual mandate is ‘necessary’ to the Act’s insurance reforms, such an expansion of federal power is not a ‘proper’ means for making those reforms effective.[10] … Read more →

Administrative, Community, Health Care Law, Health Care Reform, Historical, Hospitals, News, Regulatory

60 Days to Pay – Has Medicare Reached the Point of No Return?0

This article first appeared in the September 2012 issue of Compliance Today, a publication of the Health Care Compliance Association.

In February the Centers for Medicare & Medicaid Services (“CMS”) clarified an oft quoted existing rule: Providers must return overpayments to Medicare within 60 days “after the date on which the overpayment was identified,” or in the alternative, “the date any corresponding cost report is due, if applicable.”[1]  For providers of any size, failure to report and return Medicare overpayments pursuant to these temporal requirements may result in potential liability under the Federal False Claims Act[2], resulting in substantial monetary penalties and the risk of being denied future claims for reimbursement.

Dating back to the American Civil War, the False Claims Act (FCA) has over time become the “primary litigative tool for combating fraud” for both federal and state governments.[3] At its core, the FCA imposes liability on anyone who “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval.”[4]  While most providers have worked within a similar time frame after identifying an overpayment, it appears that the statutory requirements under the 2010 Patient Protection and Affordable Care Act [5], as amended by the Health Care and Education Reconciliation Act[6] (collectively referred to as the Affordable Care Act or health care reform) were not enough.[7] In reaction, the February 2012 regulations now leave nothing to chance, imposing upon the health care industry detailed definitions with numerous examples to assist providers in determining exactly when the 60-day clock begins.[8] … Read more →

Administrative, Clinical, Community, Health Care Law, Health Care Reform, Hospitals, News, Regulatory, Technology

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