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By Reesa Benkoff*
February 20, 2009
Obama Signs Economic Stimulus Legislation With Health IT, Medicaid Funding
On February 17, President Obama signed a $787 billion economic stimulus bill (H.R. 1) that includes additional Medicaid funding for the states, federal funding to help physicians and hospitals incorporate healthcare information technology, and money to help workers who have lost their jobs keep their health insurance. At a signing ceremony in Denver, Obama hailed the legislation—the American Recovery and Reinvestment Act—saying it would create or save as many as 3.5 million jobs, and that its healthcare provisions would help modernize the healthcare system and help millions of Americans retain their health coverage. The House approved the measure Jan. 28 by a 246-183 vote. The Senate approved it Feb. 13 by a 60-38 vote.
"Because we know that spiraling health care costs are crushing families and businesses alike, we are taking the most meaningful steps in years towards modernizing our health care system," the president said. "It's an investment that will take the long overdue step of computerizing America's medical records—to reduce the duplication and waste that costs billions of health care dollars and the medical errors that every year cost thousands of lives," Obama said. "Further, thanks to the action we have taken, seven million Americans who lost their health care along with their jobs will continue to get the coverage they need, and roughly
20 million more can breathe a little easier, knowing that their health care won't be cut due to a state budget shortfall. And an historic commitment to wellness initiatives will keep millions of Americans from setting foot in the doctor's office for purely preventable diseases."
"Taken together with the enactment earlier this month of a long-delayed law to extend health care to millions more children of working families, we have done more in 30 days to advance the cause of health reform than this country has done in a decade," Obama said.
On February 4, Obama signed the Children's Health Insurance Program Reauthorization Act of 2009 (Pub. L. No. 111-3), a move that extended coverage to an additional 4 million uninsured children and maintained coverage for nearly 7 million more (18 HLR 185, February 12, 2009). House Republican Minority Leader John Boehner (R-OH) in a Feb. 17 press release said that the economic stimulus legislation would do little to create jobs, and would harm the middle class and the economy. The bill cleared the House without a single Republican vote. "Instead of delivering a responsible, transparent, bipartisan bill to create 'jobs, jobs, jobs,' the Democratic Congress produced a trillion-dollar, special-interest pork-laden, partisan backroom deal that will do little to get our economy back on track," Boehner said.
A fact sheet released by the White House on February 17 said the legislation "will prevent health coverage loss and stabilize the system. It will make key investments now that will lower health spending in the long run." The fact sheet said that the measure's IT provisions will spur adoption of health IT by 2014 and save the federal government $12 billion over ten years. The bill includes about $20 billion in Medicaid and Medicare funding to help providers adopt IT systems. The bill also includes $87 billion in additional Medicaid funding for states, which the White House said will protect about 20 million individuals from losing Medicaid coverage.
The bill also includes $24.7 billion to help workers maintain their health insurance under the Consolidated Omnibus Budget Reconciliation Act (COBRA), which the White House said would help about 7 million workers. The measure provides a 65% subsidy for nine months to help workers who have lost their jobs keep their COBRA coverage. Furthermore, the bill includes $1 billion for clinical preventive services and community-based prevention programs, which the White House said should help the
156 million Americans who go without an influenza shot each year to get vaccinated. The bill also includes $10 billion in additional funding for the National Institutes of Health (NIH), which the White House said could create 70,000 jobs and stimulate the economy in every state because 90% of NIH funding is given to colleges, universities, and research institutions across the nation.
The bill also includes $1.1 billion for comparative effectiveness research. Of the funds, $300 million would go to the Agency for Healthcare Research and Quality; $400 million would be made available to NIH; while another $400 million would be given to the Department of Health and Human Services. The provision came under attack by congressional Republicans for several days. They argued comparative effectiveness research could be used by the federal government to interfere with the clinical decisions of healthcare providers. Democrats have countered that comparative effectiveness research will be used to help determine the best course of treatment for patients. House and Senate conferees in the bill's conference report reiterated that comparative effectiveness research should not be used to "mandate coverage, reimbursement, or other policies for any public or private payer."
"The funding in the conference agreement shall be used to conduct or support research to evaluate and compare the clinical outcomes, effectiveness, risk, and benefits of two or more medical treatments and services that address a particular medical condition," the conference report said. "Further, the conferees recognize that a 'one-size-fits-all' approach to patient treatment is not the most medically appropriate solution to treating various conditions and include language to ensure that subpopulations are considered when research is conducted or supported with the funds provided in the conference agreement," it added.
Obama Signs Economic Stimulus Legislation With Health IT, Medicaid Funding, BNA'S HEALTH L. REP. (Feb. 19, 2009) (note: registration is required to view this content).
Study Finds Central-Line-Associated MRSA Infections Declined by 50% in Hospital Intensive Care Units Over Ten Years
The rate of intravenous tube-related methicillin-resistant Staphylococcus (MRSA) aureus infections in hospital intensive care units dropped by nearly 50% over ten years, according to a recent Centers for Disease Control and Prevention (CDC) report published Wednesday in the Journal of the American Medical Association. For the report, CDC researchers examined the rate of IV tube-related infections of MRSA in more than 1,600 ICUs from 1997 to 2007. Researchers found that in 1997 there were an estimated forty-three MRSA infections per 100,000 ICU patients who were hooked up to IV tubes for at least one day, compared with the 2007 rate of twenty-one MRSA infections per 100,000 intensive-care unit (ICU) patients with the tubes. Researchers also found that rates of more treatable staph infections in ICUs declined during the ten-year study period. Researchers attributed the declines to increased prevention efforts—frequent hand-washing, instrument sterilization, and other measures—by physicians and nurses.
Researchers also found that during the ten-year period, MRSA became a more common cause of the ICU infections examined than more easily treated staph infections. Nearly 2,500 MRSA infections were linked to IV tubes during the time period, accounting for nearly 8% of all bloodstream infections associated with the IV tubes. More treatable types of staph infections accounted for less than 5%. Lead author Deron Burton of CDC said that despite the study's limitations, "We think that this is still a very important success story."
In an editorial that accompanied the report, Michael William Climo, an infectious disease specialist at a Hunter Holmes McQuire Veterans Affairs Medical Center in Richmond, VA, wrote that the report shows substantial but limited progress because MRSA became a more common cause of the ICU infections examined than more easily treated staph infections. In addition, the study only examined MRSA infections in ICUs, not in all hospital departments.
Kaiser Daily Health Policy Report, Central-Line-Associated MRSA Infections Declined by 50% in Hospital Intensive Care Units Over 10 Years, According to Study, Henry J. Kaiser Fam. Fdn. (Feb. 18, 2009).
Cigna, WellPoint Drop Flawed Reimbursement Database
On February 18, both WellPoint and Cigna agreed to end their use of the Ingenix database that was found to be intentionally underestimating usual-and-customary fees used to reimburse out-of-network care. Health insurers pay for a certain percentage of the usual and customary rates for services provided by out-of-network doctors, based on an estimate of the cost for such procedures in the same geographic area. Ingenix, a subsidiary of UnitedHealth Group, operates the Prevailing Healthcare Charges System, a database most health insurers use to determine the usual and customary rates. The database contains information on more than 1 billion claims from more than 100 health insurers. Health insurers compare out-of-network claims with those found in the database, and reduce the claim to a "reasonable" amount before they reimburse healthcare providers or members.
The database was the target of an investigation by New York Attorney General Andrew Cuomo. Investigators found that Ingenix had systematically understated market rates by as much as 28%. Cuomo said that the database is "defective and manipulated" and has prompted health insurers to underpay for out-of-network medical services. In addition, he said that the database had a "virtual monopoly" because all major health insurers used the system and no alternatives existed.
Cigna and WellPoint have each agreed to contribute $10 million toward the creation of an independent database to determine reimbursement rates that will be transparent to patients and run by a nonprofit organization. This action follows similar steps taken by UnitedHealth, which agreed to pay $50 million, and Aetna, which agreed to pay
$20 million in January. Cuomo, who reached similar agreements with a total of five other health insurers earlier this year, said that his office hopes to have the new database operational in six months and estimated that the effort will cost about $100 million.
Shortly after settling with Cuomo, UnitedHealth agreed to pay $350 million to settle a class-action lawsuit initiated in 2000 by the American Medical Association (AMA) and state medical societies in New York and Missouri. "In the wake of these agreements, the AMA calls on all health insurers to reject the fatally flawed Ingenix database," said AMA president Nancy Nielsen, MD.
But after acknowledging the current settlement, Dr. Nielsen said that past grievances still need to be dealt with. The AMA is involved in unsettled class-action lawsuits against Cigna and Aetna. "While the new, independent database is a major step forward in reforming the health insurance industry, serious damages resulting from Cigna's prior use of the flawed Ingenix database still need to be addressed," Dr. Nielsen said. "The AMA intends to continue its role in a pending class-action to obtain relief for physicians who were seriously harmed by Cigna through the insurer's long-term use of the flawed Ingenix database," she said.
Todd Neale, Another Insurer Drops Flawed Reimbursement Database, MedPage Today (Feb. 18, 2009).
Kaiser Daily Health Policy Report, WellPoint Reaches Agreement To End Use of Database To Determine Payments for Out-of-Network Medical Services, Henry J. Kaiser Fam. Fdn. (Feb. 19, 2009).
Report Finds FDA Has Reduced Enforcement of Standards for Medical Device Laboratories
The Center for Devices and Radiological Health (CDRH) at FDA in recent years has reduced enforcement of "good laboratory practices" for facilities that develop medical devices, according to a report released on Wednesday by the Project on Government Oversight. According to the report, CDRH has decreased inspections of labs that conduct clinical trials of medical devices on specialized machines or animals to ensure that the facilities comply with the standards.
CDRH in 2008 conducted only one such inspection, compared with seven in 2007 and thirty-three in 2005, the report found. In addition, CDRH has scheduled no inspections for 2009, according to the report. The report also found that several FDA officials have left the agency because of the reduction in enforcement of the standards. The report did not determine whether the reduction in enforcement of the standards resulted in injuries to patients. The report also does not indicate when CDRH decided to reduce enforcement of the standards, but traced the practice to as early as 2006.
The report states, "The decision . . . to not enforce (lab standards) is stunning in its contempt for the protection of patients." In addition, the report states, "At present, if a manufacturer knowingly violates the GLP regulation and falsely asserts compliance with GLP, that manufacturer is safe—safe from discovery, safe from disciplinary action by the FDA, safe from prosecution."
In a statement, FDA spokesperson Siobhan DeLancey said, "In recent years, we have not conducted as many inspections specific to GLP as we have in the past," adding, "We continue to review our inspectional plans, and (the agency) maintains the authority to request additional information on GLP adherence from a manufacturer and inspect any facility for GLP compliance."
Kaiser Daily Health Policy Report, FDA Has Reduced Enforcement of Standards for Medical Device Laboratories, Report Finds, Henry J. Kaiser Fam. Fdn. (Feb. 18, 2009).
Three Nursing Unions Announce Merger
Three of the largest nursing unions in the U.S.—the Massachusetts Nurses Association (MNA), the California Nurses Association (CNA), and United American Nurses (UAN)—on Wednesday announced that they will merge into a single association that will be more active in the national debate over healthcare reform. The new 150,000-member group will be called the United American Nurses-National Nurses Organizing Committee. The group will be affiliated with AFL-CIO.
In a joint statement, the groups said that "RNs should be represented by an RN union." The new group said it seeks to "provide a powerful national voice for RN rights" and will pursue minimum nurse-to-patient ratios. In addition, the group will seek to "organize all nonunion direct care RNs," and provide a national voice for nurses' rights, safe nursing practices, and nurses' health plans. Rose Ann DeMoro, executive director of CNA, said the organization will support congressional efforts to establish a single-payor healthcare system in the U.S. Debra Berger, president of CNA, said that the three unions will keep their individual identities. CNA represents 75,000 registered nurses in five states, while Maryland-based UAN represents members in twelve states, and MNA represents members in Massachusetts and has organizing campaigns in New Hampshire and Connecticut.
Michelle Ringuette—a spokesperson for the Service Employees International Union, which also represents nurses and other healthcare workers—said of the merger, "We haven't seen the details and are looking forward to learning more about it," adding, "We're encouraged by the organization's stated goal to organize nonunion direct care RNs, and by its expression of solidarity with other nurse and allied unions." Ringuette said, "We're hopeful that this will move us closer to our ultimate goal—which is to have all nurse unions working together to organize the 85% of RNs who don't yet have a union voice."
Kaiser Daily Health Policy Report, Three Nursing Unions Announce Merger, Henry J. Kaiser Fam. Fdn. (Feb. 19, 2009).
Prescription Pain Medicine Spending by Outpatients Soars Over Ten Years
Outpatient spending on prescription painkillers more than tripled in a decade, rising to $13.2 billion in 2006 from $4.2 billion in 1996, researchers reported recently. More outpatients have been using painkillers during that period, Marie N. Stagnitti, MPA, of the Agency for Healthcare Research and Quality, wrote in a statistical brief.
In 2006, the average price of each prescription for a painkiller was $57, compared with $26 a decade earlier, the brief found. This led to an annual expense for such patients of $232, up from $83. There was no difference in the proportion of men or women purchasing at least one outpatient prescription analgesic when comparing the years 1996 and 2006. When comparing the years 1996 and 2006 and the proportion of the population purchasing at least one outpatient prescription analgesic by race/ethnicity, there was an increase in the proportion of black non-Hispanics purchasing at least one analgesic, which increased from 16.5% to 19.1%.
Some 230.7 million patients in 2006 filled at least one prescription compared with 163.6 million in 1996. Still, the proportion of the population filling a painkiller prescription remained steady at 19% for both years. The researcher did not look into the conditions that led to the painkiller prescriptions. Yet the health of the outpatient population taking analgesics is changing, Stagnitti said. Fewer patients taking analgesics reported being in excellent or very good health in 2006 than they did in 1996. Only 10.4% reported excellent health, down from 11.8%; 15.8% reported very good health, down from 17.2%.
The analysis was part of the Medical Expenditure Panel Survey, a longitudinal collection of information on healthcare utilization and expenditures, health insurance, health status, and socio-demographic characteristics. The survey is co-sponsored by the Agency for Healthcare Research and Quality and the National Center for Health Statistics.
Kristina Fiore, Prescription Pain Medicine Spending by Outpatients Soars Over 10 Years, MedPage Today (Feb. 13, 2009).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.
*We would like to thank Reesa Benkoff, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for writing this email alert.