The HHS Long-Term Care Awareness Campaign

The Centers for Medicare & Medicaid Services (“CMS”), the Assistant Secretary for Planning and Evaluation, and the Administration on Aging have announced their plan to partner with Georgia, Massachusetts, Michigan, Nebraska, South Dakota and Texas in implementing the Department of Health and Human Services (“HHS”) “Own Your Future” campaign.  Own Your Future is an education and outreach program intended to encourage and promote long-term care planning among state residents.  Over the next year, program efforts will include mail solicitations to citizens from the governors of the participating states, dissemination of an “Own Your Future” Planning Kit and development of a National Clearinghouse for Long-Term Care Information website in the hopes of increasing citizens’ awareness of long-term care needs and planning.  For more of Medicare’s information on this matter, click here.  For information about the “Own Your Future” campaign, click here.  To access the “Own Your Future” Planning Kit and to view more information on the long-term care awareness campaign, click here.  Anne Sullivan Kimbel

AHRQ Reports Fewer Strokes with “Off-Pump” Cardiac Surgery

According to a new report by the U.S. Department of Health & Human Services’ Agency for Healthcare Research and Quality (“AHRQ”), performing a common heart surgery without bypassing the cardiopulmonary system may cut down on the number of surgery-related strokes and other short-term complications.  Traditionally, coronary artery bypass graft surgery has depended heavily on cardiopulmonary bypass, particularly as its harmful effects have been reduced.  Many surgeons have, in the past few years, become interested in avoiding cardiopulmonary bypass altogether, using a procedure known as “off-pump” surgery.  The report, published in the November issue of the journal Stroke, indicates that off-pump surgery is associated with a lower incidence of stroke, atrial fibrillation, and health care-associated infection.  For more information about this report, see the AHRQ website by clicking here.  Lara Parkin

OIG Issues Report About States’ Provider Safeguards for Medicaid Personal Care Services

On October 25, 2006, the Office of Inspector General (“OIG”) issued a report analyzing individual state requirements for Medicaid-funded personal care service attendants.  The purpose of the report was to determine the requirements the states have established for Medicaid personal care service attendants and state policies for oversight of those requirements.  In general, personal care service attendants enable the elderly, people with disabilities and individuals with chronic or temporary conditions to remain in their homes by assisting with daily activities such as bathing and dressing.  The services provided do not include skilled services, i.e., physical therapy, speech therapy, etc.  Personal care services are provided to Medicaid beneficiaries through individual State plans and waiver programs utilizing three delivery models: (1) agency direction; (2) consumer direction; and (3) the use of independent providers.  Although there are no federal requirements, states are required to develop qualifications or requirements for personal care service attendants to ensure quality of care.  According to the OIG, there was significant variation among the states in the requirements for attendants.  The OIG noted that the six most common requirements among the states include: (1) background checks; (2) training; (3) supervision; (4) age; (5) health; and (6) education/literacy.  The OIG also found that the states defined the same requirements differently.  Similarly, the OIG found that the frequency and level of oversight of those requirements also varied among the states.  The OIG concluded that the report could provide a foundation for future evaluation of Medicaid personal care service attendants and for other home and community based services.  To review the report click here.  Lori-Ann Bellan

FDA Backs Tracking of Medical Devices

The U.S. Food and Drug Administration (“FDA”) plans to meet with medical device manufacturers and health care administrators to determine whether millions of medical devices sold within the U.S. should be tracked through an electronic database.  The FDA currently tracks high-risk devices, such as pacemakers, but the agency now wants to track all medical devices stating that it would make it easier to conduct safety recalls.  Some hospitals support this idea stressing that it would help to reduce medical errors as well as allow them to compare the cost and quality of devices from different manufacturers.  Nonetheless, many device manufacturers are opposed to mandatory tracking, stating that device tracking should remain optional.  For further information, please click here.  India Brim

Global Pandemic Influenza Action Plan to Increase Vaccine Supply

The World Health Organization (“WHO”) has taken a significant step forward in the global effort to prepare for an influenza pandemic by publishing the Global Pandemic Influenza Action Plan to Increase Vaccine Supply.  In developing this plan through a consensus of the world’s experts in influenza, immunization, vaccine research and manufacturing, the WHO has set the world’s sights on the decisive path forward to increase the global capacity to produce pandemic influenza vaccine.  In the past year, the H5N1 strain of avian flu has spread to more than 40 additional countries and has led to the deaths of hundreds of millions of additional birds, which has heightened concern about the possibility of a human flu pandemic.  Furthermore, the number of avian flu cases in humans has more than doubled to more than 250 cases in 10 countries.  Tragically, more than half of those persons infected have died.  To date, H5N1 avian influenza has remained primarily an animal disease, but should the virus acquire the ability for sustained transmission among humans, the potential for an influenza pandemic would have grave consequences for global public health.  For more information, please click here.  Rene Quashie

Surgical Care Improvement Project Offers Consumer Tips for Surgery

Leading consumer advocacy groups have joined with the Surgical Care Improvement Project (“SCIP”) to improve patient safety during surgery and increase communication between patients and their caregivers.  Specifically, SCIP, the AARP and the National Partnership for Women and Families are working to prevent complications in four areas that comprise 40 percent of the most common complications after major inpatient surgery: infection, blood clots, and adverse cardiac and respiratory events.  On October 23, 2006, the coalition introduced a consumer tip sheet intended to provide specific questions patients can ask their physicians and nurses before surgery to ensure they are receiving care that will reduce their risk of having complications.  The tip sheet, “Steps to Safer Surgery,” is available here.  Lara Parkin

ONC Establishes State Alliance for E-Health

The HHS Office of the National Coordinator for Health Information Technology (“ONC”) has entered into a one year, $1.99 million contract with the National Governors Association’s (“NGA”) Center for Best Practices to establish the State Alliance for e-Health (“State Alliance.”)  The ONC is hoping that the State Alliance will serve as a forum in which state-level consensus-based solutions can be developed to address key challenges to interoperable health information exchange, such as: (1) state-level privacy and security issues; (2) state-law practice of medicine barriers; and (3) state-level health information organization issues in governance and sustainable financial models.  In addition, the ONC is hoping the State Alliance increases the efficiency and effectiveness of the various states’ health Information Technology initiatives.  The collaborative process will include various state-level decision makers and will also allow for the appropriate inputs of subject matter experts.  For more information about this program and other ONC initiatives, please click here.  Scott Strickland

Medicare Proposes to Improve Care Through Learning from Prescription Drug Data

CMS seeks public input on a proposed regulation on using Medicare Part D claims data for research and quality initiatives that will improve the health care and health of seniors and persons with a disability.  Medicare drug claims would be linked to other Medicare information on patient care such as hospitalizations and physician visits, and made available to researchers and Federal agencies for studies only with appropriate privacy protections and safeguards, as required by the Privacy Act and HIPAA regulations.  CMS issued a proposed regulation that will allow the Department of Health and Human Services and CMS to use Part D claims data to: 1) report on and evaluate the impact of drug use in the Medicare prescription drug program, including the interaction between prescription drug coverage and the services and utilization under traditional Medicare (Parts A & B) and the Medicare Advantage Program (Part C); and 2) conduct demonstration projects to evaluate the impact of drug coverage and make recommendations for improving the economy, efficiency or effectiveness of the Medicare program.  For more information, please click here.  Rene Quashie

Medicare Adds Performance-Based Payments For Physicians

CMS announced a new initiative to pay physicians for the quality of the care they provide to seniors and disabled beneficiaries with chronic conditions, reflecting the Administration’s ongoing commitment to reward innovative approaches to get better patient outcomes for the health dollar.  As the next step in its efforts to make higher payments for better quality, CMS announced the implementation of a new demonstration aimed at physicians practicing in solo or small to medium sized group practices.  CMS has already implemented several other “pay-for- performance” demonstrations, including the Premier Hospital Quality Incentives Demonstration which involves acute care hospitals and the Physician Group Practice demonstration which involves 10 large multi-specialty group practices across the country.  For more information, please click here.  Rene Quashie

Health Care Associations File Amicus Brief in United States Supreme Court Challenging False Claim Act Interpretations

On October 26, the American Hospital Association was joined by the Federation of American Hospitals, the Association of American Medical Colleges, and the American Health Care Association in filing a brief amici curiae in a pending case, Rockwell International Corp v. U.S.ex rel Stone.  The Federal False Claim Act requires an individual bringing an action to be an “original source” of the information upon which the allegations are based.  The brief challenges the United States Court of Appeal for the Tenth Circuit’s interpretation of the “original source” rule under the False Claims Act.  The brief argues that the Tenth Circuit has weakened the congressional intent of the “original source” rule by allowing relators “to invoke the original source exception to the public disclosure bar merely by demonstrating direct and independent knowledge of a potential statutory or regulatory violation” without direct or actual knowledge of the fraud being alleged.  The brief also argues that allowing these expansions of the jurisdictional bars of the False Claims Act would have severe consequences on the health care industry.  The Supreme Court has set the case for argument on December 5, 2006.  For more information, see the AHA website here and the brief here.  Lesley Reynolds

Senator Baucus Announces Hiring of Senate Finance Committee Health Counsel

On October 26, Ranking Minority Member, Senator Baucus announced that William Wynne has been hired as Health Counsel on the Senate Finance Committee Health and Welfare Team.  For more information on William Wynne's background, please see the press release by clicking here.  Lesley Reynolds

Senators Criticize “Medicare & You Handbook” Distributed to Seniors

On October 25, Senator Baucus, joined by ranking Democrats on the Senate Finance Committee, House Ways and Means Committee, and House Energy and Commerce Committee, sent a letter to HHS Secretary Michael Leavitt criticizing the “Medicare & You Handbook” Handbook distributed to seniors as bias.  The letter stressed that the 2007 Medicare Handbook “should be an objective guide to Medicare benefits,” and criticized the guide as presenting “a misleading and biased view of Medicare coverage and options.”  Among other criticisms the letter indicated the Handbook was unclear as to differences in benefits and cost-sharing provisions between Medicare Advantage plans and Medicare fee-for-service options.  For more information, please see the press release by Senator Baucus with accompanying letter by clicking here.   Lesley Reynolds 

New California Adverse Events Reporting Requirements and Increased Fines for Patient Safety Violations

With the adoption of Senate Bill 1301, sponsored by Sen. Elaine Alquist, California has become one of the few states that require health facilities to report “Never 27” adverse events – first identified by the National Quality Forum in its 2002 report, “Serious Reportable Events in Healthcare.”  These new reporting requirements are in addition to existing reporting requirements regarding reportable diseases and unusual occurrences.  Senate Bill 1312, also sponsored by Sen. Alquist, requires the California Department of Health Services (“DHS”) to perform expanded inspections of health facilities and, for the first time, allows DHS to levy significant fines on health facilities for violations of state law. To learn more, please click here.  Mark A. Kadzielski

Upcoming Events

On Tuesday, November 14th, 2006, Fulbright & Jaworski L.L.P. will host the Healthcare Businesswomen’s Association Mid-Atlantic Program entitled

“Navigating Drug and Device Safety in a Complex Regulatory Environment.”

Fulbright attorney Rene Quashie will be moderating and Joel Slomoff will be a featured panelist.  For more information on the event contact Lesley Reynolds or click here.