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Teaching Hospital Update - September 1-5, 2008

By Reesa N. Benkoff*

Public Health Emergency Declared for Gulf States

In declaring a public health emergency in states affected by Hurricane Gustav, HHS is waiving certain program requirements for providers to ensure that beneficiaries in public health programs continue to receive healthcare items and services. The declaration was issued on August 31, 2008, and applies to individuals enrolled in Medicare, Medicaid, and the State Children's Health Insurance Program in Alabama, Louisiana, Mississippi, and Texas.

"Many of the agency's normal operating procedures will be temporarily relaxed so healthcare services will continue to be provided to the elderly, people with disabilities and vulnerable children as they leave the areas affected by the hurricane," said acting CMS Administrator Kerry Weems in a written statement.

Critical access hospitals, for example, will be allowed to take in more patients than the statutory limit set at twenty-five patients. Also, critical access hospitals will not be required to count the expected longer lengths of stay for evacuated patients against the required ninety-six hour average. In addition, skilled nursing facilities will be able to waive the three-day prior hospitalization requirement for admission for evacuated patients, and long-term, acute care hospitals will not be required to count evacuated patients when determining compliance with the twenty-five day average length-of-stay requirement. Other exceptions were made for inpatient rehabilitation facilities, as well. CMS also expanded the definition of "home" to allow Medicare beneficiaries receiving home-health services to receive services in alternative sites.

Jennifer Lubell, Public health emergency declared for Gulf states, Modern Healthcare's Daily Dose (Sep. 2, 2008) (note: registration is required to view this content).

Whistle-Blower Lawsuits Helped Recover at Least $9.3 Billion from Healthcare Providers Accused of Defrauding States and Federal Government

Whistle-blowers have helped the Department of Justice (DOJ) recover at least $9.3 billion from healthcare providers and pharmaceutical companies that allegedly defrauded states and the federal government, according to a report published recently in the Annals of Internal Medicine.

In the 1990s, the DOJ began to use whistle-blowers in efforts to fight healthcare fraud. Whistle-blowers currently initiate 90% of such cases for the DOJ. In such cases, whistle-blowers file sealed complaints in federal court, and DOJ investigates the allegations and may join the lawsuits, while whistle-blowers receive 15%-25% of the amount recovered by DOJ in such cases.

The report analyzes DOJ records from 379 healthcare fraud cases between 1996 and 2005, although researchers only had information pertaining to three-quarters of those cases. According to the report, the number of healthcare fraud cases has decreased in recent years, while the amount that DOJ recovers has increased. The researchers cited the need to conduct additional research on whistle-blower lawsuits to determine which types of cases are more likely to lead to recoveries in order to allow DOJ to expedite such cases.

Kaiser Daily Health Policy Report, Whistle-Blower Lawsuits Helped Recover At Least $9.3B From Health Care Providers Accused of Defrauding States, Federal Government, Analysis Finds, Henry J. Kaiser Fam. Fdn. (Sep. 2, 2008).

Safety-Net Hospitals File Lawsuit to Stop CMS Drug Reporting Regulation

On August 21, 2008, a group of safety-net hospitals filed a lawsuit alleging that a federal reporting regulation concerning physician-administered drugs does not apply to hospitals under federal law and is unreasonably burdensome (University Medical Center of Southern Nevada v. Leavitt, D.D.C., No. 1:08-cv-01456, filed 8/21/08). The University Medical Center of Southern Nevada and Safety Net Hospitals for Pharmaceutical Access said in their complaint that the reporting regulation, which took effect July 1, 2008, would cost them millions of dollars and its implementation would be burdensome.

The CMS regulation (72 Fed. Reg. 39141) requires physicians to submit national drug code (NDC) identifiers with their Medicaid claims, so that the program can apply for rebates from drug manufacturers. CMS applies the regulation to physicians in outpatient hospital settings, while the hospitals argue federal law prohibits rebate collection on drugs administered in hospitals that meet certain criteria, such as having their own formulary. The hospitals also argue that the regulation would require a drastic overhaul of their billing and payment systems, a financial and logistical obstacle that has prevented some states from implementing the regulation. For example, UMCSN estimates that it faces a $5 million impact by the end of 2008 in order to comply with the regulation, and the American Society of Health System Pharmacists estimates that compliance with the requirement would add $10 to the cost of each prescription. In addition, the hospitals say that many of the drugs are part of treatments involving "compounds of many different drugs in quantities and forms that are not easily associated with a specific NDC" and so are difficult to report.

The lawsuit also alleges that safety net hospitals, such as the more than 400 represented by SNHPA, are likely to be hit particularly hard by the regulation because it will not allow those who participate in a discount drug purchasing program known as 340B to bill for more than their basic drug acquisition costs, therefore excluding costs such as transport or storage. The hospitals assert that they depend on the benefit they receive from participating in the 340B drug discount program to enable them to provide medical services to individuals who are uninsured and unable to pay the costs of their own healthcare. For such hospitals, the CMS physician administered drug rule—if broadly applied as CMS now intends—means not only the administrative and financial burden of reconfiguring and overhauling their computerized billing systems, but also the loss of much of the financial benefit that permits them to provide access to crucial pharmaceuticals for the most needy, the hospitals claimed. The hospitals seek a permanent injunction against the rule as well as confirmation that hospital physician-administered drugs are exempt from it.

The complaint is available online.

Safety Net Hospitals File Lawsuit To Stop CMS Drug Reporting Regulation, BNA HEALTH L. REP. (Sep. 4, 2008) (note: registration is required to view this content).

Humana Completes Acquisition of Metcare Health

Early in the week, Humana completed its acquisition of Metcare Health Plans, a Medicare Advantage plan in West Palm Beach, FL, for $14 million. Metcare has 7,300 members in thirteen Florida counties through AdvantageCare, its Medicare Advantage product.

Metropolitan Health Networks of West Palm Beach, FL, sold Metcare to Humana on the condition that its core provider network, Metcare of Florida, retain its provider risk agreement with current and future AdvantageCare members in those thirteen Florida counties. The deal received approval from the CMS and the Florida Office of Insurance Regulation. Humana, based in Louisville, KY, has approximately 11.5 million members.

Rebecca Vesely, Humana completes acquisition of Metcare Health, Modern Healthcare's Daily Dose (Sep. 2, 2008) (note: registration is required to view this content).

Early Growth Linked to Adult Blood Pressure

According to a recent study, the rate of weight gain in infants' first five months of life may help predict blood pressure in their mid-twenties. The study found that infants who put on weight the fastest during the postnatal period had significantly higher systolic and diastolic blood pressure at approximately age twenty-five compared with those who gained weight at a normal pace. Also, the rate of weight gain from ages nineteen months through five years was associated with higher systolic blood pressure later in life. The findings were independent of birth weight. Also, consistent with previous studies, low birth weight was associated with higher systolic—but not diastolic—blood pressure in adulthood.

"When trying to understand why some people get high blood pressure in later life," researcher Dr. Ben-Shlomo said, "we need to consider a life course approach that considers early life as well as adult life risk factors such as dietary salt and obesity." Parents should not necessarily, however, be concerned if their child gains weight at a rapid rate, he said, because the results cannot be applied on an individual basis. "It is more important to ensure children eat a healthy diet … and to encourage your children to be involved in regular exercise so that they establish sensible habits which they can maintain into their adult lives," Dr. Ben-Shlomo explained.

Although it has been well established that low birth weight is associated with higher systolic blood pressure later in life, the researchers said, few studies have examined the relationship between early growth and blood pressure. This prompted Dr. Ben-Shlomo and colleagues to follow up with participants of the Barry Caerphilly Growth Study, which tracked growth in children in two small Welsh towns from birth through age five years in the 1970s. The mean age of the participants for the current study was twenty-five.

Data were available for 362 men and 318 women who completed a questionnaire and had their blood pressure taken. The men were significantly heavier at each time point from birth through age five years. They also had higher systolic and diastolic blood pressure in adulthood. Birth length and height were also associated with later blood pressure, in addition to the associations found with birth weight and weight gain through the first five months of life. Height gain in the first five months of life, as well as from age nineteen months through five years, was associated with higher systolic blood pressure at approximately twenty-five years. Height gain from ages five months through eighteen months was also associated with higher diastolic blood pressure in adulthood. However, gestational age was not predictive of either systolic or diastolic blood pressure.

Researchers say that the study "adds further evidence that both birth weight and postnatal growth are associated with systolic blood pressure in support of both the fetal origins and growth acceleration hypotheses." According to the growth acceleration hypothesis, the catch-up growth related to nutritional supplementation following birth is more important than fetal development to the association with blood pressure. The researchers said the mechanism behind the associations was unclear, "but it has been argued that abnormal patterns of growth, both prenatally and in the immediate postnatal period, may have long-term effects on the ratio of elastin to collagen fibers in the arterial wall." In addition, they said, the mechanisms "may reflect a common genetic effect whereby genes that regulate postnatal growth themselves determine blood pressure" or "may be the influence of postnatal environmental factors" or may be a combination of the two.

They acknowledged that the study was limited by the lack of growth data from age six through twenty-four and by lack of follow-up. The researchers concluded that the study "demonstrates the importance of research into the mechanisms linking early growth and adult blood pressure."

This study is available online:
Y. Ben-Shlomo, et al., Immediate postnatal growth is associated with blood pressure in young adulthood: the Barry Caerphilly Study, 108 Hypertension J. of the Am. Heart Assn. 114256 (2008).

The Federation of American Hospitals Names Director of Healthcare Policy and Research

The Federation of American Hospitals (FAH) named Samantha Burch as its Director of Healthcare Policy and Research, a new position for the lobby group for investor-owned hospitals. According to FAH, Burch, who will turn twenty-six this month, will research and write commentaries and proposals for the federation, represent it at public forums and meetings and support its member committees.

In accepting the FAH directorship, Burch is leaving the office of Congressman Al Green (D-TX), for whom she served as healthcare aide, legislative assistant, and press secretary. Burch has also worked for the American Cancer Society and as a policy fellow with the Ohio Department of Health.

"Samantha has a great background in both healthcare policy and communications," said Chip Kahn, president of the federation. "Her experience on the Hill gives her a wonderful grasp of healthcare policy development."

Vince Galloro, FAH hires director of healthcare policy, research, Modern Healthcare's Daily Dose (Sep. 2, 2008) (note: registration is required to view this content).

*We would like to thank Reesa N. Benkoff, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.

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