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Teaching Hospital Update - October 26-30, 2009


Email Alert

By Reesa Handelsman*

October 30, 2009

House Democrats Unveil Reform Legislation

House Democrats have unveiled comprehensive healthcare legislation that aims to cover 96% of all Americans and "keeps costs under $900 billion," according to House Speaker Nancy Pelosi (D-CA).

The legislation, estimated to cost $894 billion over ten years and cover an additional thirty-six million Americans, will "expand coverage and implement key insurance reforms," establishing a new health insurance exchange that will include a public option and provide other benefits, such as ending discrimination for people with preexisting conditions, said Pelosi, flanked by members of the Democratic Caucus on the steps of the Capitol Building.

Steep cuts to Medicare, along with a surtax on individuals with incomes of $500,000, or more and couples with incomes of $1 million or more, are expected to foot much of the bill's cost.

New measures to accelerate benefits for those with preexisting conditions and other populations as early as 2010, in addition to a provision to close up Medicare's coverage gap or "doughnut hole" over ten years, have "made the bill more expensive," Rep. Gerald Connolly
(D-VA) told reporters.

A Medicaid expansion to cover individuals with incomes of up to 150% of the federal poverty level is planned. To ease the burden on states that would be called upon to cover more people, the bill would reduce the state Medicaid match rate to 7% from 10%.

Some Democratic lawmakers appeared confident the bill would easily achieve a simple majority--218 votes--to clear the House floor. Others did not seem entirely happy with the bill's last-minute changes, such as the decision to base a public option on negotiated rates instead of Medicare reimbursement rates, claiming that the new approach would not save as much money and would do less to promote insurance industry competition.

The bill still has a few procedural hurdles to clear, allowing time for Congressional Republicans to review it before it is considered on the floor possibly late next week.

In the meantime, a separate bill addressing a fix to Medicare's troubled physician payment formula was released in tandem with the House healthcare reform bill, a measure that was immediately criticized by Republicans. All House members are intent on fixing physician payments to Medicare, but to do so, "it ought to be paid for," said House Republican Leader John Boehner (R-OH), referring to the bill's apparent lack of offsets.

Jennifer Lubell, House Democrats unveil reform legislation, Modern Healthcare's Daily Dose (Oct. 29, 2009) (note: registration is required to view this content).

H1N1 Overwhelms Hospitals; Sebelius Addresses Flu Vaccine Shortage

Hospitals across the country are overwhelmed as waves of flu patients arrive at their doors, doubling their emergency room volume. Just as significant is the effect on intensive care units: a relatively small number of flu patients are requiring intensive care, but some are so ill that they will need round-the-clock care for weeks. Doctors are expecting the number of patients needing hospitalization and intensive care to rise, perhaps eventually forcing some hospitals to cancel services such as elective surgery, they say.

The White House declared a national emergency on Saturday that was designed to give hospitals the flexibility to move patients to satellite facilities if they are overwhelmed in dealing with an outbreak that is now widespread in forty-six states and afflicting millions of people, says Reid Cherlin, an administration spokesman.

Meanwhile, Obama Administration officials sought Monday to explain why so much less H1N1 flu vaccine is available than had been promised, blaming the manufacturers and the vagaries of science for nationwide shortages. Public anxiety has surged as the swine flu sweeps across the country and doctors and clinics are forced to turn away many people. The Obama Administration said in July that 80 to 120 million doses would be produced by mid-October, but only about 16.5 million doses were available at that time. More than twenty-two million doses of swine flu vaccine are available now, and most Americans should soon find it easier to get their dose, U.S. health officials said Tuesday. The slow supply trickle has frustrated Americans, who have stood in line for hours in some parts of the country.

U.S. Department Health and Human Services Secretary (HHS Secretary) Kathleen Sebelius said in television interviews Monday that officials had been "relying on the manufacturers to give us their numbers, and as soon as we got numbers we put them out to the public. It does appear now that those numbers were overly rosy." Sebelius said that eventually there will be enough supplies for everyone. However, Sebelius said she could not predict how widespread the virus will be. Roughly one thousand people have died from it in the United States. But she also said officials do not believe that there is any cause to close down schools and cease other daily activities. Dr. Anne Schuchat, who heads the Immunization and Respiratory Diseases Division of the Centers for Disease Control and Prevention, said it's hard to predict how long the H1N1 wave will continue, so even getting vaccinated a few months from now--when vaccine supplies are more plentiful--will not be too late.

In related news, two top senators overseeing the national response to the swine flu are sharply questioning the government's handling of the vaccination program, in one of the first indications that it could become a political issue for the Obama Administration. In a letter sent Tuesday to Sebelius, Senators Joseph Lieberman (I-CT) and Susan Collins (R-ME) praised the government's initial steps on the H1N1 swine flu, but said they now have "strong concerns" about the fallout from faulty estimates for how much vaccine would be available. "Unfortunately, these missteps in estimating available doses of H1N1 vaccine have effects beyond just growing public frustration; they have the potential to critically undermine our vaccine distribution efforts, which depend on accurate estimates of vaccine availability," the senators wrote. The letter requests that Sebelius "answer 13 questions, including when HHS knew that vaccine supplies would fall short of its projections, and why officials did not narrow their list of target recipients to make sure those at highest risk got the limited supplies first."

Kaiser Daily Health Policy Report, CDC: H1N1 Vaccine Supplies On The Rise, Henry J. Kaiser Fam. Fdn. (Oct. 28, 2009).

Kaiser Daily Health Policy Report, H1N1 Overwhelms Hospitals; Sebelius Addresses Flu Vaccine Shortage, Henry J. Kaiser Fam. Fdn. (Oct. 27, 2009).

HHS Secretary May Waive Some Rules to Help Hospitals Treat H1N1 Patients

To help hospitals treat a rapid influx of patients infected with the H1N1 virus, HHS Secretary Sebelius may exempt hospitals from complying with certain requirements of five major laws and programs in the event of a national health emergency, HHS said October 24, 2009. Under Section 1135 of the Social Security Act, the HHS Secretary may issue waivers for requirements related to Medicare, Medicaid, or Children's Health Insurance Program (CHIP), Emergency Medical Treatment and Active Labor Act (EMTALA), and the Health Insurance Portability and Accountability Act (HIPAA).

In a statement explaining the national emergency declaration related to the H1N1 flu pandemic, HHS said that some requirements under the five laws and programs, if not waived, "may impede the ability of health care facilities to fully implement disaster operations plans that enable appropriate care during emergencies." HHS said: "Waivers are permitted only to the extent they ensure that sufficient health care items and services are available to meet the needs of Medicare, Medicaid, and CHIP beneficiaries in the emergency area during the emergency period. The 'emergency area' and the 'emergency period' are the geographic area, in which, and the time period, during which, the dual declarations exist." Some waivers would allow hospitals to establish another screening location away from the hospital and to "facilitate transfer of patients between ERs and inpatient wards between hospitals," HHS said. Both actions would require waivers of EMTALA and HIPAA requirements.

While the HIPAA privacy rule is not suspended during a national health emergency, the HHS Secretary may waive a patient's right to request privacy restrictions or confidential communications and the provision requiring doctors to obtain permission from the patient to speak with family members or friends. Privacy rule waivers only would apply to emergency areas for the duration of the emergency period stated in the national emergency declaration, hospitals operating under an emergency protocol, and up to seventy-two hours after implementation of a disaster protocol, according to HHS.

"The H1N1 epidemic is moving rapidly," HHS said in explaining its use of waivers. "By the time regions or health care systems recognize they are becoming overburdened, they need to implement disaster plans quickly." "[Section] 1135 Waivers still require specific requests be submitted to HHS and processed, and some state laws may need to be addressed as well," it said. "Adding a potential delay while waiting for a National Emergency Declaration is not in the best interest of the public."

Section 1135 waivers have been used in previous disaster events including Hurricane Katrina in 2005, Hurricanes Ike and Gustav in 2008, and as a precautionary step during the 2009 presidential inauguration.

HHS Secretary May Waive Some Rules To Help Hospitals Treat H1N1 Patients, BNA'S HEALTH L. REP. (Oct. 29, 2009) (note: registration is required to view this content).

Flu Vaccine Benefits Pregnant Women and Babies

For pregnant women, an influenza vaccination leads to bigger babies and infants who are less likely to get the flu, according to three studies presented below. Experts said the findings--presented at the Infectious Diseases Society of America annual meeting--might help persuade pregnant women who are reluctant to get a flu shot. It might also bring the issue to the attention of obstetricians, who typically do not raise the notion of a flu shot with their patients, said William Schaffner, MD, of Vanderbilt University Medical Center in Nashville.

"This is powerful information for obstetricians and pregnant women to have," said Schaffner, who moderated a news conference at which the studies were discussed. The findings are all the more persuasive, he said, because different investigators using varied methods "all came out with the same answer."

The issue is important, according to Marietta Vazquez, MD, of Yale University, because the proportion of pregnant women who are vaccinated against the flu is "dismal"--fewer than one in four, she and others said. Vazquez and colleagues conducted a continuing case-control study of infants admitted to their hospital starting in 2000. Infants with confirmed flu were the cases, and they each were matched with two controls who were admitted for other reasons. The study's goal is to compare the mothers--using both questionnaires and medical records--to see if they were vaccinated during their pregnancy, Vazquez said. For the 119 women with complete medical records available and an infant with the flu, only 5% had been vaccinated, the researchers found. By contrast, of the 172 mothers of control infants, 16% had been vaccinated. The difference suggested that flu vaccine given to mothers during pregnancy is effective in preventing hospitalization of their infants, Vazquez said. Vazquez said the results might help persuade more women to get vaccinated. "If they're not getting vaccinated for themselves," she said, "maybe they'll do it for their babies."

In a second study, researchers led by Saad Omer, MBBS, PhD, of Emory University in Atlanta, looked at prematurity and gestational weight in Georgia from June 2004 through September 2006. During that time, Omer said, there were 6,410 births, and 15% of the mothers had received the flu vaccine during pregnancy. Logistic regression analysis showed that--when flu was at least locally active--unvaccinated mothers were 56% more likely to have a premature baby. If flu was widespread, the risk rose to 72%. In periods of widespread flu activity, unvaccinated women were 69% more likely to have a child small for its gestational age. Neither effect was seen outside the flu season, he said. Although the findings need to be replicated, Omer said, the flu vaccine "may be an important tool for addressing the problem of immaturity."

In a similar finding, vaccinated mothers in a study in Bangladesh had babies who were 215 grams heavier, on average, than those born to unvaccinated women, according to Mark Steinhoff, MD, of Cincinnati Children's Hospital Medical Center. As in the Georgia study, the effect was seen only during the flu season, Steinhoff said. "It's a fairly specific effect," he said, that is both large and significant. The finding comes from a randomized trial whose primary finding, Steinhoff said, was that the flu vaccine reduced cases of influenza in babies by 63% and reduced febrile respiratory illness in babies by 29% and by 36% in mothers. "It shows again that when you prevent flu in a pregnant woman, you benefit the mother, you benefit the infant, and, we think, this also shows that you benefit the fetus," Steinhoff said.

Omer and colleagues reported earlier this month in the American Journal of Obstetrics & Gynecology that a review of existing literature shows that pregnant women are at elevated risk of flu-related complications. On the other hand, they said, the risk of vaccine side effects is small. "There is substantial evidence that vaccination is not only safe for pregnant women," Omer said in a statement, "but that it is critical for protecting women and their infants against serious complications from the flu."

Michael Smith, IDSA: Flu Vaccine Benefits Moms and Babies, MedPage Today (Oct. 29, 2009).

HCFAC Report Says Agencies Recovered Nearly $2.3 Billion for Programs in 2008

The federal government recovered nearly $2.3 billion in fiscal year (FY) 2008 for the Medicare and Medicaid programs, HHS and the Department of Justice (DOJ) said in a joint annual report on the Health Care Fraud and Abuse Control (HCFAC) Program. Approximately $1 million in the recoveries were from judgments and settlements in healthcare fraud cases, with additional funds coming from administrative impositions, according to the report required by Congress under HIPAA, which established the HCFAC program. The recoveries included more than
$344 million for the federal Medicaid program, the report said.

The HCFAC program provides federal funding to the HHS Officer of the Inspector General, DOJ, Centers for Medicare & Medicaid Services, and the Federal Bureau of Investigation to coordinate federal and state enforcement activities to combat healthcare fraud. According to the FY 2008 report, the program has recovered $4 for every $1 of funding from the HIPAA-created HCFAC account. In 2008, federal prosecutors opened more than 950 criminal healthcare fraud investigations, involving more than 1,600 defendants, the report said. During the same year, DOJ opened more than 840 civil healthcare fraud investigations and had more than 1,300 cases pending.

HCFAC Report Says Agencies Recovered Nearly $2.3 Billion for Programs in 2008, BNA'S HEALTH L. REP. (Oct. 29, 2009) (note: registration is required to view this content).

*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.

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