By Clinton R. Mikel*
May 22, 2009
Department of Justice, HHS Boosts Number of Investigators, Prosecutors Looking at Medicare, Medicaid Fraud
On Wednesday, May 20, 2009, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) launched the Health Care Fraud Prevention and Enforcement Action Team. The Team is intended to detect and prevent fraud in Medicare and Medicaid. The DOJ also announced plans to establish teams to address fraud in the Medicare Part D program and Children's Health Insurance Program (CHIP). Wednesday's announcement also included a recommendation by President Obama's Administration to include $311 million in the fiscal year 2010 budget to address healthcare fraud, a 50% increase from 2009 fiscal year's budget. According to Attorney General Eric Holder, efforts to combat healthcare fraud will contribute to the Administration's healthcare overhaul plans.
The task force, which will include HHS and DOJ staff members, law enforcement agents, and prosecutors, will meet biweekly. Under the plan, existing enforcement teams in Miami and Los Angeles will be expanded and new teams will be established in Houston and Detroit, where officials say suspicious billing patterns have emerged. In addition, the plan will set up task forces in ten other major cities, which were not named. The enforcement teams will increase site visits to durable medical equipment suppliers. In addition, officials will expand training to help providers identify and prevent fraud or other mistakes. The task force will use electronic claims data to detect unusual billing problems. HHS Secretary Kathleen Sebelius said the task force also intends to simplify billing systems and assist state officials in conducting Medicaid audits. According to Holder, the joint task force will allow officials to share real-time intelligence data on healthcare fraud by monitoring claims payments, billing patterns, and targeted surveillance.
Healthcare fraud costs are estimated by some to cost U.S. taxpayers at least $60 billion annually. In the past, the largest sums recovered by the federal government have resulted from DOJ interventions in lawsuits against pharmaceutical companies filed under the False Claims Act. Tony West, head of DOJ's Civil Division, said, "There is an incredible amount of money that can be recovered and returned to the health care trust fund, and that has a real impact."
Kaiser Daily Health Policy Report, Department of Justice, HHS Boosts Number of Investigators, Prosecutors Looking at Medicare, Medicaid Fraud, Henry J. Kaiser Fam. Fdn. (May 21, 2009).
More Sleep for Residents Could Be Costly
Teaching hospitals would have to spend up to $183 extra per admission to implement Institute of Medicine (IOM) recommendations that residents work fewer hours and get more naps. According to the authors of a study in the New England Journal of Medicine (NEJM), "hospitals are likely to incur losses under the IOM-recommended changes."
The fatigue-reduction strategies outlined in the IOM's 2008 report could cost $1.6 billion a year, but it's not clear whether it would reduce or increase medical errors, said researchers. The issue of resident fatigue drew national attention in 2003, when the Accreditation Council for Graduate Medical Education (ACGME) mandated that residents work no more than eighty hours per week (averaged over a four-week period), and no more than thirty hours straight.
After those rules went into affect, Congress asked the IOM to do a five-year follow-up study on the effects of the ACGME rules. In December 2008 the IOM concluded that the shortened workweek did not reduce fatigue because residents were trying to cram in the same amount of work into less time and, as a result, were severely sleep deprived. The IOM report called for an uninterrupted, five-hour nap for every sixteen-hour shift for residents, a reduced workload, increased supervision, and better managed patient hand-offs.
The cost per major teaching hospital would be $3.2 million per year to pay for mid-level healthcare providers who could take over some duties for the residents, and $3.5 million per year to hire additional residents. Despite the 2003 rules, many residents still spend nine to twenty-four hours per week on "noneducation tasks that lower-level providers can perform," according to the NEJM study. While proponents of the push for less work and more sleep for residents argue that fatigue can lead to workplace errors, studies have yet to pinpoint how many medical errors occur because clinicians didn't get enough sleep. Two national studies found cutting residents' hours did not lead to higher patient mortality rates, but it didn't reduce them either.
The authors of the latest study acknowledge that the effects of the IOM recommendations are unknown. In the best-case scenario, they wrote, making sure residents are well-rested and not overworked could reduce errors by 11.3%—the magic number at which the cost of implementing the IOM recommendations would be neutral. But they noted that the additional hand-offs that would occur if residents were given more breaks could actually lead to a 10% increase in errors. Studies have shown hand-offs are linked to adverse events and longer hospital stays.
Melvin Blanchard, MD, Kenneth Polonksy, MD, of Washington University School of Medicine, and David Meltzer, MD, PhD, of the University of Chicago said that effects of the IOM recommendation on resident education must be considered. They noted that clinicians who train residents often set an example by showing an "overriding consideration" for patients. "The proposed system will signify to our trainees that the overriding consideration is the duration of their shift," the doctors wrote, adding that it would be a constant "ethical" dilemma to decide to hand-off a patient because an "arbitrary time limit" has been met. The requirement for days off and naps will hinder residents' ability to follow patients through the entire clinical process, they said.
The ACGME will decide whether to implement the IOM recommendations. The group has commissioned an independent, outside literature review of studies related to duty hours, fatigue, and the resident learning environment, said an ACGME spokesperson.
Emily P. Walker, More Sleep for Residents Could Be Costly, MedPage Today (May 20, 2009).
California Hospitals Fined for Quality and Safety Lapses
The California Department of Public Health fined thirteen hospitals on
May 21, 2009, for violating health codes that endangered patients. Three of the hospitals had left foreign objects inside patients. Each violation carries a $25,000 fine.
Some of the hospitals were fined for not properly following surgical procedures, resulting in patients having to undergo additional surgeries. Other violations include restraining a patient for radiological exams and failing to assess and intervene when a patient's condition declined.
The violations occurred in 2007 and 2008. All cited hospitals are required to submit a plan of correction to the state, which addresses their violations.
California Hospitals Fined for Quality and Safety Lapses, Modern Healthcare's Daily Dose (May 21, 2009) (note: registration is required to view this content).
Women Still Drinking During Pregnancy
Despite the Surgeon General's warning that alcohol can affect unborn children, pregnant women haven't changed their drinking habits much over the past two decades, the Center for Disease Control and Prevention (CDC) said. The average annual percentage of pregnant women who drank remained relatively stable at about 12% for any alcohol use and 2% for binge drinking.
The U.S. Surgeon General has consistently advised women against drinking alcohol during pregnancy. National prevalence of fetal alcohol syndrome is around 0.5 to 2.0 cases per 1,000 births, but the other fetal alcohol spectrum disorders occur about three times as often. The prevalence of any alcohol use and binge drinking among pregnant and non-pregnant women did not change substantially between 1991 and 2005. The average annual proportion of pregnant women who used any alcohol was 12.2%, while 1.9% reported binge drinking.
Women with the highest rates of drinking during pregnancy were older, college graduates, employed, and unmarried. While it's not well understood why drinking habits differ across certain aspects of social status, researchers had a few possible explanations. It could be that older women may be more alcohol dependent and have more difficulty abstaining from alcohol while pregnant, they speculated. Also, they said, more educated women and employed women might have more discretionary money to spend on alcohol. Finally, unmarried women might attend more social occasions where alcohol is served, researchers said.
Researchers emphasized that healthcare providers should routinely ask women of childbearing age about their alcohol use and inform them of the risks of drinking during pregnancy. Alcohol use levels before pregnancy are a strong predictor of alcohol use during pregnancy, the researchers said. Many women who use alcohol continue to do so during the early weeks of gestation because they don't realize they're pregnant, as about half of all births are unplanned. About 40% of women realize they're pregnant at four weeks' gestation, a critical period for fetal organ development, the researchers noted.
Kristina Fiore, Women Still Drinking During Pregnancy, MedPage Today (May 21, 2009).
Republicans Introduce Health Reform Plan that Would Provide Tax Credits to Purchase Health Coverage, Establish State Insurance Exchanges
Republican Senators Richard Burr (NC), Lamar Alexander (TN), and Tom Coburn (OK) and Republican Representatives Devin Nunes (CA), and Paul Ryan (WI) introduced the Patients' Choice Act (S. 1099, H.R. 2520) on Wednesday as counter proposal to Democratic healthcare reform plans.
The act would require states to separately establish health insurance exchanges made up of private health insurers through which individuals could pick their coverage. The legislation would provide $5,700 in tax credits to families and $2,200 in tax credits to individuals to subsidize coverage premiums. An additional $5,000 tax credit would be provided to low-income families. The credits would be funded by taxing employer-provided health benefits.
Under the plan, states would be allowed to shift state residents covered by Medicaid into private coverage. The measure would also establish a system of health coverage auto-enrollment at emergency departments, motor vehicle departments, and through employers. The plan does not establish any new government healthcare programs. The bill's sponsors hope to achieve universal coverage for U.S. residents. According to the bill's sponsors, the plan is budget neutral.
Burr said he plans to offer the bill as an alternative amendment on the Senate floor to the healthcare overhaul bills to be proposed by Democrats on the Senate Finance Committee and the Senate Health, Education, Labor and Pensions Committee. Burr said, "We decided to construct what we decided was the best policy for health care. And then, hopefully, it's obvious," adding, "We're going to introduce it to the American people and let them voice an opinion on whether they want real health care reform.
. . . If the American people want it, we're in the game."
The plan has little chance of passage because of the Democratic majority in both chambers; it reflects, however, some Republican lawmakers' growing dissatisfaction with Democrat's approach towards the healthcare system.
Kaiser Daily Health Policy Report, Republicans Introduce Health Reform Plan That Would Provide Tax Credits To Purchase Health Coverage, Establish State Insurance Exchanges, Henry J. Kaiser Fam. Fdn.
(May 21, 2009).
ONC, CMS Recovery Act Work Plans Indicate Statutory Mandate Challenges
On May 18, 2009, the Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare and Medicaid Services (CMS) released their plans for implementing the health information technology provisions of the economic stimulus act. The plans suggest that the agencies have concerns about their ability to deliver desired results as quickly as Congress intended.
The documents are the latest indication that a rapid and successful replacement of all paper medical records with electronic health records (EHRs), as called for in the American Recovery and Reinvestment Act (ARRA), is a major and perhaps impossible challenge. On May 15, after some of his outside advisers decried the ARRA timeline, National Coordinator David Blumenthal said Congress was not aware of how long it will take to make the transformation.
The CMS implementation plan includes a section listing barriers to effective implementation of ARRA's Health Information Technology for Economic and Clinical Health Act. "There are a number of critical factors that will create barriers to effective implementation if not implemented early enough," CMS said. The listed challenges include: (i) establishment of health information exchanges in the "near term" over which electronic health records will travel between provider institutions; (ii) development of privacy, security, and technology standards, as well as processes for certifying that EHR systems meet those standards, in time for vendors to produce and market compliant systems; and (iii) development of the definition of what "meaningful use" of EHR systems by providers means in time for ONC and CMS to demonstrate its use over a health information exchange.
Brian Wagner, government affairs director for the E-Health Initiative, stated that he expects ONC to propose a definition for "meaningful use" within the next month. The HITECH Act requires ONC to issue an interim final definition of meaningful use by December 31, 2009. Blumenthal recently told his advisory committee on HIT policy that an interagency workgroup is developing a draft proposal. ONC's implementation plan states that there are "a number of complex issues" to be considered about the HIT adoption effort, including the need to do the "foundational work required to support" the tens of billions dollars in payment incentives to be made to doctors making "meaningful use" of EHRs for Medicare and Medicaid patients as of 2011.
Noting that Blumenthal began work at ONC only in mid-April, the implementation plan states, without providing dates, that decisions "will be made" about how best to address: (i) IT standards development and harmonization; (ii) the certification and testing processes; (iii) privacy and security policy development; and (iv) issues around governance, workforce training, and education for healthcare providers and consumers.
ONC, CMS Recovery Act Work Plans Indicate Statutory Mandate Challenges, BNA'S HEALTH L. REP. (May 21, 2009) (note: registration is required to view this content).
*We would like to thank Clinton R. Mikel, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's update.
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.