By Reesa Handelsman*
November 25, 2009
CDC Watching H1N1 Mutation, But No Cause for Alarm
The Centers for Disease Control and Prevention (CDC) is keeping a careful eye on a mutation in some strains of the pandemic H1N1 flu that Norwegian researchers isolated from three patients with severe disease. The mutation has been seen "sporadically" in the United States, according to Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases. However, in the United States the mutation has been associated with mild disease, she said, although the Norwegians isolated it from the first two patients who died of the disease in that country.
The mutation was also found in a third patient who had severe disease, according to a statement from the Norwegian Institute of Public Health. Schuchat told reporters that there are "theoretical reasons" for thinking that the mutation might make it easier for the virus to penetrate to the lower lungs, leading to more severe disease. However, she said in the United States patients have had severe lower respiratory infections caused by strains without the mutation, as well as mild disease caused by strains with the mutation.
"It's just too soon for us to say what this is going to mean long term," Schuchat said. "It's an important finding for the influenza virologists, and they're looking into it." She added that the mutation "has no implications for how good the match of the vaccine is and no implications for treatment with antiviral medicine." "But it's important for us to continue to track influenza viruses and look for changes," she said.
The agency will be watching to see if the mutation spreads and if it is more common in cases of severe disease, she added. Schuchat said influenza-like activity in the United States continues to be high, although the number of states reporting widespread disease has dropped slightly--to forty-three states from forty-six last week. At the same time, she said, some states--such as Maine and Hawaii--are reporting increased activity this week. Overall, flu activity is "much greater than we would ever see at this time of the year," Schuchat said.
The CDC has had reports this week of an additional twenty-one pediatric deaths associated with the flu, fifteen of them confirmed to be H1N1. The other six could not be subtyped but were influenza A and probably H1N1, Schuchat said. Two-thirds of the 171 lab-confirmed H1N1 pediatric deaths have involved children with underlying conditions, such as asthma or cerebral palsy, she said. The vaccine supply is still less than the agency had hoped for, she said, but a total of 54.1 million doses have become available since the beginning of the season. Of those, Schuchat said, states have ordered 93%. She added that vaccine manufacturers have told the CDC that 94.5 million doses of the seasonal flu vaccine have been distributed.
Michael Smith, CDC Watching H1N1 Mutation, But No Cause for Alarm, MedPage Today (Nov. 20, 2009).
Congress Targets Senior Abuse
As part of healthcare overhaul legislation, lawmakers are taking steps that would for the first time establish a federal beachhead in fighting elder abuse. The House healthcare bill would launch a nationwide program of background checks for people who care for the elderly, overhauling a patchwork of state laws that critics say has allowed known offenders to repeatedly end up in positions of trust.
The Senate is considering an even more expansive Elder Justice Act. It would boost federal aid for identifying and investigating elder abuse at the state and local levels, require long term care providers to report possible crimes to federal authorities, and create new oversight within the U.S. Department of Health and Human Services for coordinating state and federal anti-abuse efforts. These provisions, already approved by the Senate Finance Committee, are included in the healthcare legislation that is being prepared for floor debate after Thanksgiving. With broad support in and out of Congress, at least some of the measures appear to have good prospects for being enacted into law. More than 500 advocacy groups have lined up behind the legislation. It still faces opposition on budget grounds, although proponents say the cost of the Elder Justice Act--about $757 million over four years--is pocket change in the context of a near $1 trillion healthcare bill.
The current healthcare bills would require states to conduct comprehensive screening of a wide range of people who are working with the elderly, including those in the burgeoning and unregulated area of home-based care. More than a dozen states, including California and Florida, currently do not regulate those workers. Most states only check the backgrounds of medical workers, such as nurse aides, and only for crimes they committed in their own states.
The legislation also would require states to establish clear criteria for prohibiting employment of applicants with a history of violent crime. It also would mandate the development of appeals processes for individuals who are denied employment, plus systems in which workers who have been checked and cleared, but who subsequently commit a disqualifying crime, would be terminated.
About 11% of people ages sixty and older suffer from some kind of abuse every year, according to a March study for the National Institute of Justice, an arm of the Department of Justice (DOJ). Other studies have shown that elderly victims of abuse, neglect, and exploitation have twice the risk of dying within a year.
Anecdotal evidence of such abuse abounds. A home aide working near Fresno was convicted of involuntary manslaughter last year after giving an eighty-five-year-old woman a lethal overdose of morphine and methadone and ransacking her house. The caregiver had a history of domestic assaults and drug smuggling. Last month, a postal worker in San Diego pleaded guilty to one count of felony financial elder abuse after taking more than $50,000 from elderly women on her delivery route. Financial exploitation of the elderly costs as much as $2.6 billion a year. The problem was highlighted with the October conviction of the son of New York philanthropist Brooke Astor for stealing tens of millions of dollars from his mother while she was suffering from Alzheimer's disease. But advocates for the elderly say such abuse occurs on a lesser scale much more frequently.
Opponents say that they are concerned about runaway federal spending and stepping on the toes of state and local governments. Others question the expense and efficacy of background checks when even proponents acknowledge that most abuse is perpetrated by people who are already well known to the victims.
Supporters say elder abuse should be addressed in healthcare overhaul legislation because it pushes up healthcare costs and because financial exploitation of the elderly leaves many destitute and reliant on public assistance. "This is prevention, which is a healthcare issue," says Robert Blancato, who heads the Elder Justice Coalition, an umbrella group for more than 500 groups that support the legislation. They include AARP, the American Bar Association, and industry groups representing nursing homes and long term care providers, among others. "The universal lack of resources, the enormous variation across jurisdictions and the low priority given to elder abuse and neglect make it difficult to see how significant progress can be made without federal standards and financial support," concluded researchers at Texas A&M University in a report prepared for DOJ last month.
Rick Schmitt, Congress Targets Senior Abuse, Henry J. Kaiser Fam. Fdn. (Nov. 23, 2009).
GAO Cites "Pervasive Deficiencies" in CMS Controls
The Centers for Medicare & Medicid Services' (CMS') "pervasive deficiencies" in its internal control of contractors expose the agency to increased risk of improper payments and waste, the U.S. Government Accountability Office (GAO) concludes in a new report. Based on a random sample of contract awards and modifications, the report projected that at least 84% of the fiscal year 2008 actions lacked one or more key control required by federal regulations, and at least 37% lacked three or more controls. For example, according to the report, CMS entered contracts obligating the government to reimburse costs without first ensuring the contractor had an adequate accounting system.
The GAO describes a "weak overall control environment" with poor planning and inaccurate data on "the nature and extent of its contracting." The study is a sequel to a 2007 review of certain CMS contracts, and the new report finds that the CMS "has not substantially" addressed seven of its nine earlier recommendations. Acting CMS Administrator Charlene Frizzera wrote in a response to the GAO that its review is specific to just eleven of "literally hundreds" of internal controls required for federal contracting and "does not provide a complete picture" of the controls established by CMS.
Gregg Blesch, GAO Cites "Pervasive Deficiencies" in CMS Controls, Modern Healthcare's Daily Dose (Nov. 24, 2009) (note: registration is required to view this content).
New Medicare Rules on Home-Oxygen Affect Patients
New Medicare rules designed to reduce waste and fraud in medical-equipment reimbursements are driving some home-oxygen suppliers out of business and leaving patients scrambling to find new providers. The new payment rules, effective January 1, 2010, affect the more than one million people who rely on Medicare to pay for oxygen services, which relieve the symptoms of conditions such as emphysema and chronic obstructive pulmonary disease.
Under the new rules, Medicare pays suppliers at the prevailing rate--an average of $200 a month, paid 80% by Medicare, 20% by patients--for the first three years after a patient begins coverage. Suppliers are then required to continue providing oxygen services to patients for an additional two years, but at a sharply reduced payment rate. After that, patients are entitled to receive new equipment, and Medicare will resume paying suppliers at the higher rate.
The changes are part of broader efforts by Congress and the Centers for Medicare and Medicaid Services (CMS) to address waste and fraud in reimbursements for so-called durable medical equipment, which includes things like home-oxygen machines, wheelchairs, and walkers. CMS says it expects to save about $220 million in the fiscal year that began last month. The agency says it had been paying too much for oxygen equipment and that payments for the first three years should cover service costs for the two-year gap.
Suppliers say those calculations don't account for how much it actually costs to provide services, such as delivering oxygen tanks. Some are balking at accepting new patients who are near or have already reached the three-year limit on full payments. The companies would have to provide oxygen services for the next two years while getting minimal payments for follow-up visits and other services.
Some smaller, independent oxygen providers, which account for much of the industry's business, say they are being driven out by separate Medicare rules that took effect October 1, 2009, and require durable medical-equipment suppliers to be accredited and to post a surety bond. The changes are supported by many in the industry, but some small suppliers say they cannot afford them. It costs $2,500-$3,500 for a company to go through an accreditation survey, says Wayne Stanfield, president of the National Association of Independent Medical Equipment Suppliers. But a supplier may spend tens of thousands of dollars to comply with the stringent requirements.
Amy Merrick, Oxygen Rules Pinching Patients, WALL STREET JOURNAL, Nov. 24, 2009.
*We would like to thank Reesa N. Handelsman, Esquire (Hall Render Killian Heath & Lyman PC, 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.