Chair's Column: A Bridge Over Troubled Water
By David H. Johnson, Bannerman & Johnson, P.A.,
Not long ago, I had dinner with my friend Beth Schermer, who related her experiences in being recruited by then-Arizona governor Janet Napolitano to assist in bringing divergent forces together to establish a new four-year medical school in Phoenix. The interested parties included the two major state universities, numerous hospitals and medical groups, research organizations, and foundations - all with their own vision, priorities and needs. Multiple obstacles were encountered en route to a resolution. To Beth the project was both challenging and exhilarating. It led her to rethink the role of leaders and lawyers in navigating conflict and bringing many parties to a single goal, and ultimately led to her refocusing her efforts from the traditional practice of law to business consulting.
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Drug Shortages in the United States
By Rina Shah, U.S. Office of Personnel Management on National Healthcare Operations, Washington, DC
According to the American Society of Health System Pharmacists (“ASHP”), there are currently about 200 drug shortages, ranging from the Acetazolamide Injection to the Zoster Vaccine Live. A recent study claimed that these numerous drug shortages are not as bad as they seem because they are limited to a few disease areas and generic injectables. Despite the purportedly limited scope, drugs that are vital to treating major diseases such as childhood leukemia and breast cancer are part of the current shortages. Due to concerns about delays in treatment, increased morbidity and mortality, and higher healthcare costs, manufacturers and the government have been attempting to remedy the issue. As government legislation is still pending and other responses are fairly recent, there has not been any reliable information to indicate whether these strategies are working.
CMS Launches New Demonstration Programs
By Andrew B. Wachler and Jessica C. Lange,
Wachler & Associates, P.C., Royal Oak, MI
On November 15, 2011, the Centers for Medicare & Medicaid Services (“CMS”) announced three demonstration programs, directed to “…strengthen Medicare by aiming at eliminating fraud and abuse.” The three demonstration programs are the Part A to Part B Rebilling Demonstration Program (“AB Rebilling Demonstration”), the Recovery Audit Pre-Payment Review Demonstration Program and the Prior Authorization and Pre-Payment Review of Power Mobility Devices (“PMD”s). The demonstration programs stem from Executive Orders announced by President Obama. The first order was announced on November 23, 2009 with the purpose of reducing improper payments and waste in federal programs.
Food and Drug Administration (“FDA”) Regulation of Mobile Health
By Catherine Barrett, Federal Working Group, Washington, DC
The consumer electronics, IT and telecommunications industries are carefully monitoring the Food and Drug Administration’s (“FDA”) interest in creating a new body of regulations designed to govern the use and marketability of certain hardware, software applications, mobile medical apps, mobile phones and accessories. On July 21, 2011 the FDA released draft guidance entitled “Mobile Medical Applications.” The purpose of the draft guidance is to “inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (“mobile applications” or ‘‘mobile apps’’).”
Risk-Bearing under the MSSP ACO Final Rule
By Gregory W. Bee, Taft Stettinius & Hollister LLP, Cincinnati, OH
and Catherine T. Dunlay, Taft Stettinius & Hollister LLP, Columbus, OH
On October 20, 2011, The Centers for Medicare & Medicaid Services (“CMS”) released a final rule (the “Final Rule”) for accountable care organizations (“ACOs”) under the Medicare Shared Savings Program (the “MSSP”). The Final Rule was promulgated pursuant to the 2010 Patient Protection and Affordable Care Act. The Final Rule contains a number of changes from the proposed rule (the “Proposed Rule”) that, taken together, lessen downside financial risks to participants and, therefore, lower some of the barriers to entry for smaller and less experienced providers. This article provides an overview of the changes affecting risk-bearing by participating ACOs.
Supreme Court to Decide the Fate of the Obama Administration’s Landmark Healthcare Reform Act
By Michelle Browning Coughlin, Holland N. (“Quint”) McTyeire, V, and Peter L. Thurman, Jr., Bingham Greenebaum Doll LLP, Louisville, KY
On Monday, November 14, 2011, the United States Supreme Court granted certiorari to hear arguments regarding the constitutionality of the Patient Protection and Affordable Care Act (“PPACA”). Cases challenging PPACA have been moving through courts across the United States. In general, the cases filed have examined whether a mandate requiring individuals to purchase health insurance exceeds Congress’s power under the Commerce Clause of the United States Constitution.
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