by Vickie Yates Brown, Frost Brown Todd LLC, Louisville, KY
The Section held its annual Washington Healthcare Summit November 17-18 at the Pentagon City Ritz-Carlton in Arlington, Virginia. As always, the chance to hear from our colleagues in government and leaders in our field was particularly engaging as well as timely. Though the two-day event covered a wide-range of speakers and topics, I have highlighted two seminar presentations, which captured the Summit’s most prominent themes.
The Wait is Over, the Patient Safety and Quality Improvement Act Final Rule is Published
by Bill Hopkins, Brown McCarroll LLP, Austin, TX
On November, 21, 2008, the U.S. Department of Health and Human Services (HHS), published the final rule implementing the Patient Safety and Quality Improvement Act (PSQIA). Under the Final Rule, effective on January 19, 2009, healthcare providers can establish internal patient safety evaluation systems to collect and analyze patient safety events and voluntarily report such events within a legally secure environment of privilege and confidentiality protections to a Patient Safety Organization (PSO). PSOs will be certified by the Agency for Healthcare Research and Quality (AHRQ) and charged with collecting patient safety data from all participating providers, aggregating the data, and performing detailed analysis of the data to identify patterns of failures in the healthcare system and propose measures to eliminate patient safety risks as a means to improve patient outcomes. Under this system, providers will now have a comfort zone to fully disclose detailed patient safety information to a PSO without the concern of whether that information will be subject to disclosure or discovery in a future regulatory or liability action. The providers will also benefit on the back-end of the transaction as PSOs will also in a position to provide expert advice to healthcare providers regarding best practices derived from analyzing patient safety event data.
Issues to Consider in the Planning Stages of a Medical-Legal Partnership
by Jessica Barth, Wishard Health Services, Indianapolis, IN and Chad Priest, and Erin Lewis, Baker & Daniels, LLP, Indianapolis, IN
It is by now a truism that social, economic, and environmental factors contribute to poor health. For example, stress, poor diet, and exposure to workplace dangers and environmental toxins all play a role in illness. Healthcare providers are in an excellent position to recognize these social, economic, and environmental causes of illness, but may not feel equipped to help their patients address them. The medical-legal partnership (MLP) model evolved to provide healthcare providers with access to legal help for their patients, with the ultimate goal of improving patient and public health.
Moratorium on Medicaid Rules
by Priscilla Keith, Health and Hospital Corporation of Marion County, Indianapolis, IN
On June 30, 2008, the President signed into law the Supplemental Appropriations Act of 2008 (Public Law 110-252, HR 2642), which included provisions to extend the moratoria currently set on six Medicaid regulations. The effective date for the regulations is now extended until April 1, 2009. The proposed regulations were issued by the Centers for Medicare and Medicaid Services (“CMS”) in an effort to generate greater fiscal accountability and transparency in the Medicaid process.The Governmental Accountability Office (“GAO”) and the Office of Inspector General (“OIG”) recently performed studies that highlighted areas where the fiscal integrity of the Medicaid system needed improvement. The Congressional Budget Office (“CBO”) reports that the moratorium on the regulations would increase direct spending to $1.8 billion over the 2008-2013 period and $1.9 billion over the 2008-2013 period, as a result of the delays in implementing the regulations. The overall net impact of savings would be $3 million over both the 2008-2013 and 2008-2018 periods, respectively. As such, the intent of the proposed regulations were to reduce the amount of Medicaid reimbursements in areas dealing with rehabilitative services, intergovernmental transfers, graduate medical education, case management services, school based administrative and transportation services, and provider taxes.
Should Drug and Device Manufacturers Be Immunized Against State Tort Law Liability If Their Products Have Been Approved by the FDA? No
by Marilyn Mann, U.S. Securities and Exchange Commission, Washington, DC
In the November 2008 issue of eSource, Jeffrey D. Zigler wrote to oppose the enactment of federal legislation that would overturn a recent Supreme Court decision that held that the preemption clause of the Medical Device Amendments of 1976 bars common-law claims challenging the safety or efficacy of a medical device marketed in a form that has received pre-market approval from the Food and Drug Administration (FDA). Mr. Zigler, a consultant to the medical device industry, argues that the legislation, the Medical Device Safety Act of 2008, should be opposed because (1) the legislation would be disadvantageous to the medical device industry,and (2) the FDA premarket approval process for medical devices sufficiently protects consumers.
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Public Health & Policy Interest Group
The Public Health & Policy Interest Group provides leadership to the ABA Health Law Section, and the ABA at large, in the area of public health and policy matters.
The IG is led by Chair Priscilla D. Keith, Health & Hospital Corporation of Marion County, Indianapolis, IN and Vice-Chairs Michael DeLucia, Department of Justice of the State of New Hampshire, Concord, NH; Howard Kaufman, Boca Raton, FL and Clifford M. Rees, Santa Fe, NM
If you would like to join the Interest Group, continue by clicking the following link: Health Law Section IG Sign-up Form.
ABA eSource Editorial Board
The ABA Health eSource Editorial Board is led by Chair Lisa Genecov, Locke Lord Bissell and Liddell LLP, Dallas, TX and Editor Marla Durben Hirsch, Potomac, MD. Editorial board members Michael E. Clark, Hamel Bowers & Clark LLP, Houston, TX; Adrienne Dresevic, Wachler & Associates, P.C., Royal Oak, MI; and Conrad Meyer, Chaffe McCall, LLP, New Orleans, LA.
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|The opinions expressed are those of the authors and shall not be construed to represent the policies or positions of the ABA or the ABA Health Law Section. |