Vital Signs Where's That Infection?

I walked into the emergency room and was confronted immediately. “Twenty-year-old woman, vomiting for 12 hours,” Andreas, my ER resident, told me. “Total body pain, fevers, can barely walk.”

He handed over the nursing note. “Chief complaint: chills, fever, nausea, vomiting.” Surprisingly, the patient’s temperature, pulse, and blood pressure were normal.

“Normal vitals and no fever?” I asked. “Can’t be too sick, can she? Gastroenteritis?”

“She looks pretty bad,” Andreas responded. “And there’s something else. Two weeks ago they treated her for a bladder infection. She finished the antibiotics. A few days later the burning and frequency returned.”

“Let’s say hi,” I suggested. Curled into a ball, the young woman barely looked up as we walked in. Her mother stood by her bedside, holding vigil.

“She won’t stop vomiting, doctor.”

“Any belly pain? Fever?”

With great effort, the daughter turned to face us. “I feel so bad” was all she could say.

“Can I examine your abdomen for a moment?” I asked. Grimacing, she slowly straightened out.

“Any pain here?” I asked, gently probing her thin abdomen. “Here?” She shook her head.

“And are you still having urinary symptoms? Burning?” She nodded.

“They took a culture five days ago,” the mother interjected. “The doctor said he would call if there was a problem, but we haven’t heard anything. I assumed it was OK.”

“Can you sit up for me?” I asked the daughter. She heaved herself upright. Gently, I tapped the lower ribs on the right where one kidney lies.

“That OK?”

“Yup.”

I thumped the left. She winced and arched her back. “Ouch. Yes, that hurts.”

I looked at Andreas. “Pyelo?” Pyelonephritis is Latin for “kidney on fire”; in plain English, it means a kidney infection.

“Problem is, she has no fever,” Andreas said, “and the urinalysis showed no white cells.”

That made no sense. Turning back to mother and daughter, I repeated, “For five days you’ve had burning when you urinate, right?” They nodded.

I turned to Andreas. “Dysuria. Flank pain. Vomiting. Should equal pyelo, no?” He gave a shrug, as if to say, “Don’t you know by now that even the simple stuff isn’t simple?”

“She has a kidney infection,” I announced to the mother. “Some parts of the puzzle are missing, but we’re going to start her on antibiotics right away.”

“Please, doctor,” the mother replied, looking relieved. “This has gone on too long.”

I hailed Steve, the young woman’s nurse. “Let’s repeat the temperature and the urinalysis, OK?”

“Coming up.”

The textbooks say high fever and pyelo nephritis go together like mustard on a hot dog. At this point, with no fever and no infection-fighting white cells in the urine, my diagnosis hinged on little more than the young woman’s story and my fist-tap examination of her side.

Steve walked over. “Temp normal. Ninety-eight even.”

“Let’s hang the antibiotics anyway, OK?”

“You got it.”

Bladder infections, or UTIs (urinary tract infections), are like mosquito bites: common, mostly just annoying, but packing the occasional nasty surprise. In toddlers, UTIs can cause high fevers, and—given the impossibility of getting a two-year-old to pee into a cup—they can drive ER doctors nuts waiting for a sample in order to complete a fever workup. More than half of all women will contract a UTI over their lifetime. Some sexually active young women average one every two years.

Why women? It’s a matter of plumbing: The female urethra’s relative proximity to the rectum gives fecal bacteria—especially the always abundant E. coli—easier access to the urinary system than does the male anatomy. Some women even produce specific proteins on their cell surfaces that bacteria can latch onto.

And no, cranberry juice does not cure UTIs.

Treatment in an otherwise healthy woman is a three-day course of a fluoroquinolone antibiotic like ciprofloxacin. Bactrim (also known as Septra) used to be the standard, but over the past decade resistance has soared. In the western United States more than 20 percent of E. coli strains are now resistant—too high for initial use of the drug as empirical therapy.

Because the symptoms of a bladder infection are so specific—and the bacterial culprits are so predictable—a patient’s reported symptoms and a positive urinalysis are generally enough to prompt treatment. Bacterial cultures are not done in most cases because they are both expensive and redundant.

To dismiss UTIs as either simple or trivial would be a big mistake, however.

UTI is a straightforward diagnosis all doctors love to make, but life-threatening abdominal infections can mimic UTIs. Such infections can cause urinary burning and urgency (and a positive urinalysis) when infected intestines abut and inflame the bladder. The bladder, in that respect, is the canary in the abdominal coal mine. So much so that a young man with urinary symptoms and abdominal discomfort most likely has appendicitis, not a UTI.

Left untreated, bacteria can escape the bladder by two routes: via capillaries into the bloodstream or up the ureters into the kidneys. The bloodstream route bedevils older, and especially diabetic, patients, many of whom never feel the telltale symptoms of a bladder infection. Instead they present with full-blown sepsis: fever, confusion, vomiting, and low blood pressure. In younger patients the kidney usually takes the first hit: Flank pain strikes like a baseball bat, with fever and vomiting following close behind.

Years ago pyelonephritis mandated hospitalization, blood cultures, and IV antibiotics—all driven by the fear that recurrent infections can permanently scar the kidney. With the advent of fluoroquinolone drugs, outpatient treatment is now routine: a prescription for oral antibiotics, and presto.

My patient’s second microscopic urinalysis showed white cells in the urine, though not a ton. Fever or no fever, this was definitely pyelo.

“What do you think?” I asked Andreas. “A routine course of cipro at home?”

“Her serum white count’s pretty high,” he replied. “And you can’t take pills if you’re vomiting.”

“OK,” I agreed. “And if the admitting team squawks about no fever, too bad.”

I pulled the mother aside. “She’ll be fine,” I said. “I just want to keep her overnight, give her antibiotics by vein, and make sure the vomiting settles down.”

“Just a day?”

I smiled. “No promises. But most likely yes.”

Two days later I was visiting another patient in the intensive care unit when a familiar form passed by. The mother.

My throat tightened. Only critically ill patients end up in the ICU.

“What happened?” I sputtered.

“Her blood pressure went down the next morning,” she said, her voice raspy and tired. “They rushed her up here. Pumped her full of fluid and more antibiotics. The infection had gotten into her bloodstream.”

I hurried into her room. My patient looked wan but OK. The monitor showed a normal blood pressure—and I started breathing again.

“I feel better today,” the daughter said, wearing the expression survivors of high-speed rollovers get. I racked my brain for what we could have done differently. Andreas had given her plenty of fluid. We’d started antibiotics right away. But apparently the bacteria had begun their invasion of her bloodstream before we even saw her. And I had almost sent her home.

“How do we make sure that this never happens again?” the mother asked.

Glad to change the subject, I explained: “Prevention is key. You should keep antibiotics on hand and start them at the first sign of trouble. You know your body. With UTIs, your symptoms are straightforward. In women who get them very frequently, it’s an accepted practice.”

The mother’s face brightened, knowing that next time she and her daughter could find treatment without having to wait for a doctor’s help.

Tony Dajer is chairman of the department of emergency medicine at New York Downtown Hospital in Manhattan. The cases described in Vital Signs are real, but names and certain details have been changed.

Greater Louisville Medical Society President's eVoice August 2009

An article by Atul Gawande, MD, is all the rage throughout Washington, D.C. It is described as "must reading" by President Obama and it may help shape the discussion on health care reform. Dr. Gawande is a surgeon and a writer, and a staff member of Brigham and Women's Hospital. Many of his works were written during his residency (perhaps with an 80 hour work week, I could have done that, too, yeah, right). I have read many of his works including two books, "Complications: A Surgeon's Notes on an Imperfect Science" and "Better: A Surgeon's Notes on Performance" as well as one of his older articles in The New Yorker, "The Bell Curve" where he talks about how there is a bell curve for everything, even physician performance. He wonders where he is on the curve, which of course makes all of us wonder the same (and everyone cannot be above average). Anyway, I have always found his books and articles fun to read, provocative and usually, right on. His June 1, 2009, article in The New Yorker entitled, "The Cost Conundrum" is certainly making the rounds within the reform debate. In it, he talks about a Texas town, McAllen, which is one of the most expensive healthcare markets in the country. On average, Medicare spending is twice the national average in McAllen, Texas as compared to almost anywhere else in the country. And yet, people are not healthier, the quality isn't better, and the malpractice wasn't worse (actually it was better, as Texas had passed caps on malpractice). However, the folks in this town had more specialist visits, more tests, and more surgeries than patients in other parts of the country. Why? You need to read the entire article, but it comes down to culture and incentives. The information that Dr. Gawande is referring to comes from the Dartmouth Atlas Study (www.dartmouthatlas.com) which looked at Medicare spending in the last two years (and also in the last six months) of a patient's life. With the endpoint being death, it served as a nice risk adjustment (none of the "our patients are sicker than theirs" argument as they all died within those timeframes). You can look at any state or area and compare nationally the rate of Medicare spending, including the number of physician visits in the last two years or 6 months of life, the number of tests, the utilization of ICU beds, and other spending. Not surprisingly, places like Mayo Clinic provide high quality care at some of the lowest costs, even on their Florida campus. Overall, Louisville is just above the national average in most categories, but there is much variation between hospitals throughout the state. President Obama and all the lawmakers in Washington have all read Dr. Gawande's article. While much of the current debate seems to center on expanding coverage, whether or not to offer a public option, create a health insurance exchange, or tax insurance benefits, one thing is for sure...quality will start to take center stage, over quantity.

Sincerely, Lynn Simon, MD GLMS President

Vaccine Production Is Horribly Outdated. Here Are 3 Ways to Fix It.

From the day it was first reported in Mexico, swine flu took less than four months to become a full-fledgedworldwide pandemic. So what’s the most effective way to stop the virus from infecting most of the globe? Widespread vaccination—which is why U.S. health officials are debating a nationwide swine flu vaccination program that would mandate the creation of 600 million immunizations, more than five times the 115 million vaccines administered each year to battle the seasonal flu.

Because of the flu virus’s notorious ability to mutate, a large-scale immunization program would require manufacturers to quickly produce vast quantities of vaccine.

Unfortunately for all of us, it’s unlikely that current vaccine production methods—which have been in use for more than half a century—could produce the quantity of vaccine that would be necessary in an emergency. Today’s vaccine production is so slow, costly, and inefficient that the U.S. Department of Health and Human Services allotted $1 billion in 2006 toward the development of new techniques.

With the first trials for a swine flu vaccine currently underway in Australia, the question of how to produce huge quantities of vaccine quickly has never been more pressing. In particular, three new techniques under development could be the answer should another pandemic occur.

Vaccines work by exposing the body to particles called antigens, which trigger an immune response. In most modern vaccines, antigens come in the form of bits of deactivated virus. When the body senses these particles, it kick-starts specialized immune defenses, including the production of immune cells known as lymphocytes, which learn to recognize and attack viral DNA. Once the body eliminates the invaders, it stores a "memory" of that particular invader for years, guarding against future infections.

The traditional way to produce vaccines involves injecting live viruses into a fertilized chicken egg, then letting the egg incubate and become infected with the virus. Afterwards, the liquid inside the egg is removed and mixed with an embalming fluid called formalin. It renders the virus incapable of causing an infection but still provokes the immune response that will protect vaccine recipients against future infections. Not all vaccines are produced using the same antiquated system; for example, the HPV vaccine known as Gardasil, which was approved by the FDA in 2006, is made in yeast cells. But flu vaccines are still produced within eggs.

Unfortunately, this process is fraught with problems: It’s slow (the eggs typically need to incubate for about half a year), inefficient (on average, it takes one to two eggs to yield a single dose of vaccine), and unreliable: Not only can the eggs spoil, but they may also produce the virus at varying rates. As a result, the serum they yield may be too weak or impure to provide immunity with the lowest possible incidence of side effects.

For these reasons, scientists are working on new methods to combat these problems. Of course, often the new methods present problems of their own, which the researchers must iron out before the techniques become ready for wide-scale production.

You Can't Have Dessert Till You Eat Your Vaccines
One technique involves genetically modifying edible plants to produce vaccine antigens. Scientists have already developed a potato that boosts immunity against Hepatitis B, and are working on vaccine-producing peanuts.Rakesh Tuli, of India’s National Botanical Research Institute in Lucknow, is developing antigen-spiked nuts to protect against cholera and rabies. He says that because the nut crop is high in protein, it produces vaccine antigens more efficiently than does a leafy plant. In fact, his analysis indicates that a football-sized field plot could yield 450 million doses of vaccine. “Two acres of land is enough to vaccinate a population the size of India,” Tuli says.

Unfortunately, although these plants show promise, it’s questionable whether these edible vaccines will ever be mass-produced for flu or any other disease. The technique remains highly controversial among environmentalists, despite the enthusiasm of researchers like Tuli. “In the last few years, we’ve decided that it’s probably not a good idea to produce [vaccines] in food products,” says Hugh Mason, an Arizona State University vaccine researcher who helped develop the first edible vaccine. “No matter how careful you are, even if you establish regulations, there’s always a chance that someone would not follow the guidelines,” thereby contaminating wild plants or food crops with genetically engineered ones, he explains. If modified plants escape into the natural environment, they could contaminate water supplies, irreversibly alter wild species, or even enter the human food chain, which nearly happened in 2002.

There’s also the matter of antigen regulation. Because many of these genetically modified vaccines are meant to be eaten, it can be difficult to regulate exactly how much antigen a half-cup of potato or a handful of peanuts delivers. “Ultimately, an edible vaccine might lose its antigenic activity,” Mason says.

Still, some scientists maintain their faith in plant-produced vaccines, saying that the plants could be grown in a greenhouse to make sure modified plant material remains separate from wildlife. “We are talking about isolated, protected cultivation to make sure that vaccine plants will not get mixed up with non-vaccine plants,” says Tuli, who believes the cost of an acre-large greenhouse would be small compared to the efficiency and savings of the new method.

Infecting a Plant to Save a Human
To avoid the problems that come with altering plant genes, other researchers are investigating a plant-based technique that does not fundamentally change a plant’s DNA. Instead, this method combines a small amount of DNA from a human-infecting virus, like influenza, with a plant virus known as tobacco mosaic virus. This hybrid virus then infects a plant, eventually killing it—but not before the virus replicates, producing scads of vaccine proteins in the process. In this technique, the DNA of the human virus is not incorporated into the plant’s genes, so it isn’t present in the seeds or pollen. Additionally, the plant containing the hybrid virus can be easily incinerated.

“As the virus kills the plant, we harvest the vaccine before the plant withers and falls apart,” says Charles Arntzenof Arizona State University, who worked with Hugh Mason on plant vaccines. “The virus tries to behave like a virus, replicating and reproducing its genes. But instead of making a virus, it makes the proteins we’re interested in.” Extracting the vaccine would be simple; manufacturers could squeeze the bright green juice from the tobacco leaves, harvest the human viral DNA, and then destroy any remaining traces of the genetically mixed virus.

“Because [the tobacco virus] kills the host it’s in, it’s not going to spread and appear someplace else,” Arntzen says. “From an environmental standpoint, it’s a dead-end genetic mechanism, but one that we can exploit to manufacture what we’re interested in.” This method may be more viable than edible vaccines for two reasons: The tobacco plants see no permanent genetic alteration, which means a much lower risk of an environmental impact, and the vaccines are extracted in a liquid and then administered as injections, meaning no rotten potatoes or unpredictable vaccine doses.

One Pest to Get Rid of Another
The third way researchers hope to galvanize vaccine production doesn’t involve plants, and it could be the method that is the closest to filling a syringe near you. In this technique, researchers inject a strip of viral DNA into the gene sequence of E. coli bacteria, then allow this hybridized cell to multiply and produce the desired antigen. It takes only a day to grow enough of these bacteria to fill a 1,000-liter tank—enough to provide about 400 million influenza vaccinations. That’s two-thirds of the dosages that would be necessary if U.S. health officials go forward with their immunization campaign. It’s also a stark contrast to today’s egg-based technology, which takes about six months to produce a mere 100 million doses, according to Alan Shaw, CEO of VaxInnate, a company at the forefront of bacteria-based vaccine production.

The bacteria process requires low-tech equipment and fewer person-hours to produce a high number of dosages, meaning cheaper vaccines than the egg-based method. The method is relatively new, but far bacteria-based vaccines have proven effective: A seasonal flu vaccine produced by VaxInnate successfully protected humans in clinical trials, and the company’s recently tested swine flu vaccine immunized mice against the virus.

Still, experts can’t say whether vaccines produced with any one of these new techniques will be ready to displace the egg method in the near future. Plus, even if we convert to bacteria- or plant-based vaccine production, it’s difficult to predict whether lower manufacturing costs will transfer to the consumer—when it comes to pharmaceuticals, the price of producing a vaccine or drug is just one variable among many that ultimately determine how much you’ll pay at the doctor’s office.

But necessity may bring progress. As new disease strains continue to develop, and globalization and travel make it easier to pass disease across geographical borders, the ability to whip up huge quantities of effective vaccine is becoming increasingly important. “One of the things I think we humans will find ourselves facing on an ever greater frequency,” Shaw says, “is some kind of an emerging pathogen that pops somewhere.” And while the death count is nothing to celebrate, a pandemic like swine flu may be just what’s needed to boost these new technologies, and carry our outdated vaccine production methods into the 21st century.

Obama Is Taking an Active Role in Talks on Health Care Plan

WASHINGTON — In pursuing his proposed overhaul of the health care system, President Obama has consistently presented himself as aloof from the legislative fray, merely offering broad principles. Prominent among them is the creation of a strong, government-run insurance plan to compete with private insurers and press for lower costs.

Behind the scenes, however, Mr. Obama and his advisers have been quite active, sometimes negotiating deals with a degree of cold-eyed political realism potentially at odds with the president’s rhetoric.

Early last month, for example, hospital officials were poised to appear at the White House to announce a deal limiting their industry’s share of the costs of the overhaul proposal when a wave of jitters swept through the group. Senator Max Baucus, the Finance Committee chairman and a party to the deal, had abruptly pulled out of the event. Was he backing away from his end of the deal?

Not to worry, Jim Messina, the deputy White House chief of staff, told the hospital lobbyists, according to White House officials and lobbyists briefed on the call. The White House was standing behind the deal, Mr. Messina told them, capping the industry’s costs at a maximum of $155 billion over 10 years in exchange for its political support.

Some Democrats and industry lobbyists now argue that, in negotiating deals through Mr. Baucus’s committee with powerful health care interests, the White House was tacitly signaling as early as last spring that it might end up accepting something more modest than the government insurer the president has said he prefers.

The Finance Committee, for example, appears to be coalescing around the idea of nonprofit insurance cooperatives instead of a government-run plan. It is a proposal the health care industry prefers, but many liberal Democrats oppose, in both cases because cooperatives are likely to have less leverage over health care prices.

Rahm Emanuel, the White House chief of staff, disputed that the administration had elevated the work of the Senate finance panel above the four other committees that have all approved strong government insurers.

“They are an important committee,” Mr. Emanuel said. “They have a bipartisan process. The president would like that to work, just as he is proud that the other committees have done their work. They don’t get an exalted status over everybody else.”

But he also acknowledged the political realities that have made the Finance Committee’s still-unfinished cooperative plan a center of attention.

“We have heard from both chambers that the House sees a public plan as essential for the final product, and the Senate believes it cannot pass it as constructed and a co-op is what they can do,” Mr. Emanuel said. “We are cognizant of that fact.”

Asked whether the president would accept the weaker co-op, Mr. Emanuel declined to comment. “I am not going to fast-forward the process,” he said.

Industry lobbyists and moderate Democrats in both chambers, though, argue that the White House’s actions behind the scenes show a recognition that the finance panel’s anticipated compromise is the most likely template for any final legislation.

“The House has largely been a sideshow,” said Representative Jim Cooper of Tennessee, a member of the so-called Blue Dog caucus of conservative Democrats. “The Senate Finance Committee is where it really matters. That’s the bottleneck.”

Members and staff of the four other committees working on health care say the White House has generally stayed on the sidelines of their work. “They have been — what is a good way to put it? — available for consultation,” Mr. Cooper said. “They haven’t been hands-off, but they haven’t been hands-on.”

Mr. Obama and his top aides have immersed themselves in the Senate Finance Committee process. The president talks to Mr. Baucus several times a week, people briefed on their conversations say. Mr. Obama has also held a few calls with the panel’s ranking Republican, Senator Charles E. Grassley of Iowa.

In addition, Mr. Obama invited both senators to a private lunch at the White House early in the summer and met with six panel members for another White House session last week. White House advisers have held long evening and weekend meetings with Finance Committee staff members, even poring over copies of the Tax Code together.

Nancy-Ann DeParle, charged with leading the White House health effort, has a standing biweekly meeting with Mr. Baucus, while Peter R. Orszag, the White House budget director, has spent so much time in the senator’s office that he helps himself to the Coke Zeros tucked away in Mr. Baucus’s personal refrigerator.

Lobbyists for both the drug and hospital industries say that, as early as June, White House officials directed them to work out cost-saving deals with Mr. Baucus’s committee.

Drug industry lobbyists said they negotiated a deal to contribute $80 billion over 10 years toward the cost of an overhaul with Mr. Baucus, under White House supervision, before taking it to the president for final approval. House lawmakers have said they were caught by surprise when it was announced.

Hospital industry lobbyists, speaking on condition of anonymity for fear of alienating the White House, say they negotiated their $155 billion in concessions with Mr. Baucus and the administration in tandem. House staff members were present, including for at least one White House meeting, but their role was peripheral, the lobbyists said.

Several hospital lobbyists involved in the White House deals said it was understood as a condition of their support that the final legislation would not include a government-run health plan paying Medicare rates — generally 80 percent of private sector rates — or controlled by the secretary of health and human services.

“We have an agreement with the White House that I’m very confident will be seen all the way through conference,” one of the industry lobbyists, Chip Kahn, director of the Federation of American Hospitals, told a Capitol Hill newsletter.

Mr. Emanuel and liberal Democrats argued that the White House had worked more closely with the Senate Finance Committee because it was stepping in to break up legislative logjams. In the same way, they said, Mr. Obama and Mr. Emanuel had personally interceded to resolve a last-minute revolt by conservative House Democrats that threatened to derail a bill in the House Energy and Commerce Committee at the end of July.

Representative Henry A. Waxman, the California Democrat who is chairman of the Energy and Commerce Committee, said the president had personally assured House members that he did not intend to let the Senate Finance Committee determine the final legislation.

“This is going to be a genuine conference with give and take,” Mr. Waxman said. “The president has said that personally to the senators, and he has said it personally to us.”

He added: “The president has said he wants a public option to keep everybody honest. He hasn’t said he wants a co-op as a public option.”

Still, industry lobbyists say they are not worried. “We trust the White House,” Mr. Kahn said. “We are confident that the Senate Finance Committee will produce a bill we fully can endorse.”

Study: Tamiflu Too Risky & Ineffective for Use by Children

Antiviral treatments such as Tamiflu should not be administered to children under the age of 12 because the risks of the drugs outweigh the possible benefits in lessening symptoms of swine flu, according to a studypublished in the British Medical Journal.

Although antiviral drugs can shorten the duration of the flu in children by an average of 1.5 days, they fail to fight certain effects of the infection, having little effect on the risk of asthma flare-ups, for instance. In fact, the drugs can bring dangerous side effects like vomiting, which can be dangerous because it puts children at risk of dehydration. In the research review, scientists looked at four trials of 1,766 children treated with antivirals, including 1,243 with confirmed flu, and three trials of 863 who were exposed to flu but didn’t exhibit symptoms and were treated with antivirals preventively. Only one trial looked at children with asthma [CBC]. Overuse of antivirals can also increase the risk of viral strains that become resistant to such treatments.

Although the study was based on clinical data collected from children with the seasonal flu, not swine flu, co-author Matthew Thompson said there was no reason to think the conclusions would not also apply to the current relatively mild outbreak of swine flu [Reuters]. The most common side effects of Tamiflu were vomiting, nausea, and abdominal pain, while Relenza, an antiviral that is inhaled, most often caused nausea and headache, according to the study.

In regards to using the drugs to prevent the spread of swine flu, the researchers found that 13 people need to be treated to prevent one additional case, meaning antivirals reduce transmission by 8% [BBC], according to the study, a rather small effect. That indicates that antivirals should not be used prophylactically, but rather to alleviate symptoms in severe cases of flu in adults.

Related Content:
80beats: Swine Flu Vaccine Trials Begin in Australia; U.S. Up Soon
80beats: Killer Flu Strains Lurk & Mutate for Years Before They Go Pandemic
80beats: How the Federal Government is Preparing for Possible Swine Flu Emergency

AMA ADVOCACY UPDATE

July 31, 2009

House Energy and Commerce Committee mark up resumes

Yesterday, the House Committee on Energy and Commerce resumed its mark up of H.R. 3200, the American Affordable Health Choices Act of 2009, working late into the night considering amendments. Key amendments of particular interest to physicians were voted on during the debate on the following issues:

Comparative effectiveness:

An amendment offered by Rep. Michael Rogers (R-Mich.) was adopted to clarify that comparative effectiveness research could not be used by the federal government to deny or ration care. A second amendment was adopted, sponsored by Rep. Phil Gingrey, MD (R-Ga.), stating that the Centers for Medicare and Medicaid Services may not use federally-funded clinical comparative effectiveness research data to make Medicare coverage determinations on the basis of cost. A third amendment authored by Rep. Chris Murphy (D-Conn.) was adopted specifying that the work performed by the Center for Comparative Effectiveness must be based on consultation with, and review by, appropriate trade associations and professional membership societies.

Medicaid and Children’s Health Insurance Program (CHIP):

The Committee adopted an amendment offered by Rep. Murphy to ensure adequate Medicaid payment rates. Rep. Jerry McNerney (D-Calif.) and Rep. Murphy offered an amendment, which was adopted, specifying that coverage waiting periods under the CHIP program do not apply to children who lose health insurance coverage, who are under 2 years of age, or for whom health insurance coverage is unaffordable. An amendment offered by Reps. Joe Barton (R-Texas) and Nathan Deal (R-Ga.) to allow CHIP and Medicaid funds to be used to purchase private health insurance coverage was defeated.

Medical home:

Rep. Donna Christensen, MD (D-VI) successfully offered two amendments to provisions related to a community-based medical home pilot program requiring the Secretary to: (1) seek to eliminate racial, ethnic, gender, and geographic health disparities through the pilots; and (2) select one of the U.S. territories as a pilot location.

Medicare physician payment

: Rep. Michael Burgess, MD (R-Texas) offered an amendment, which was defeated, that would have replaced the sustainable growth rate (SGR) system with Medicare physician payment updates based on the Medicare Economic Index.

©

American Medical Association 2009 1

Public health insurance option:

An amendment offered by Rep. Burgess, requiring provider payment rates under a public plan option to be negotiated and not based on rates paid by another public program, was defeated. This issue is expected to be considered again in an upcoming vote on the compromise agreement reached between committee chair Henry Waxman and members of the Blue Dog Coalition. A second amendment offered by Rep. Burgess to eliminate the public plan option was also defeated.

Medical liability:

Rep. Burgess offered an amendment that would have implemented federal medical liability tort reforms, including a $250,000 cap on noneconomic damages. This amendment was defeated. A second amendment, offered by Rep. Deal, that would have provided liability protections to physicians who transfer EMTALA patients to more appropriate health care facilities was also defeated. Rep. Bart Gordon (D-Texas) is expected to offer three additional medical liability amendments for the committee’s consideration today.

The committee is scheduled to resume its mark up of H.R. 3200 at 10:00 ET this morning. Please go to

www.energycommerce.house.gov to track amendments and votes throughout this process.

Senate Finance Committee mark up postponed until fall. Physicians groups need to work Senate offices on Medicare physician payment issue

Bipartisan negotiations between members of the Senate Finance Committee are ongoing, and committee chair Max Baucus (D-Mont.) announced yesterday that the panel would be unable to mark up a bill before Congress returns from its summer recess in September. He pledged that negotiators will continue to meet during the month of August to resolve their differences.

Details of agreements that have been reached thus far began to emerge this week, although no information is available in writing. It has been reported that negotiators have scaled back the Medicare physician payment relief in the compromise package to a one-year temporary halt to the payment cuts being produced by the SGR formula. Currently, the committee proposal would provide a 0.5 percent Medicare physician payment update in 2010, in lieu of a scheduled 21.5% cut. The AMA and its coalition partners will be working over the August recess on strategies to secure a repeal of the irrational Medicare physician payment formula this year. This includes laying the ground work for a Senate floor amendment to replace the SGR. As previously reported, the House health reform package (H.R. 3200) would erase the SGR debt and establish a new Medicare physician payment formula. The Obama Administration has taken a number of steps this year to facilitate efforts to replace the SGR with a new payment formula. During August, physician groups will need to educate Senators on the need to scrap the SGR instead of creating another temporary "patch."

AMA eVoice® Alert

Aug. 1, 2009

House Energy and Commerce Committee concludes health system reform mark up

The House Energy and Commerce Committee met throughout the day on Friday to mark up H.R. 3200, the “American Affordable Health Choices Act of 2009,” completing its work at 9:00 p.m. last night. The bill was approved by a vote of 31 to 28, with five Democrats voting against it.

The long anticipated Blue Dog agreement was adopted late in the day as an amendment offered by Rep. Mike Ross (D-Ark.). Highlights of that agreement include:

• Public Plan Option: Requires the Secretary of Health and Human Services (HHS) to negotiate payment rates in the public plan, so that they would not be lower than Medicare or higher than the average rates paid by private plans in the Health Insurance Exchange. Requirements for physicians and other providers to opt-out of participating in the public plan are specified.
• CO-OP: Establishes a Consumer Operated and Oriented Plan (CO-OP) program, through which grants and loans will be made for the creation and initial operation of not-for-profit, member-run health insurance co-ops that provide insurance through the exchange.
• Subsidies and mandates: Those who are offered insurance by their employers would be ineligible for subsidies (affordability credits) in the exchange unless their premiums equal more than 12 percent of their income. More small businesses would be exempt from the pay-or-play mandate.
• Medicaid: Reduces federal responsibility payments (FMAP) for required Medicaid expansions from 100 percent to 90 percent beginning in 2015.
• End-of-life planning: Provides for dissemination of information on end-of-life planning by qualified health benefits plan (QHBP) entities, including option to establish advanced directives and physicians’ orders for life-sustaining treatment. Specifies that the QHBP entity shall not promote suicide, assisted suicide or the active hastening of death (consistent with state law) and that the information shall not presume the withdrawal of treatment. Prohibits promotion of assisted suicide.
• Center for Medicare and Medicaid Payment Innovation: A Center for Medicare and Medicaid Payment Innovation would be established to test the effect of payment models on spending and quality of life under the Medicare and Medicaid programs. The Secretary may implement the model on a nationwide basis if it improves quality without increasing spending and/or reduces spending without reducing quality.

Descriptions of other amendments of interest that were considered yesterday follow. (The list is not exhaustive.)

• Public health plan: Rep. Cliff Stearns (R-Fla.) successfully offered an amendment that would prohibit taxpayer bailouts to subsidize the public plan. An amendment offered by Rep. George Radanovich (R-Calif.) that would have required the public plan to be subject to state taxes and other requirements was defeated. An amendment by Rep. Joe Barton (R-Tex.) was rejected that would have, in lieu of a public health insurance option, expanded state reinsurance programs and state high risk pool programs for those with pre-existing or other high risk conditions, and an amendment by Anthony Weiner (D-N.Y.) was withdrawn that would have established a single payer health care system.
• Medical liability reform: Rep. Doyle (D-Pa.) offered and the committee adopted a block of amendments (not available for review this morning) that included language drafted by Rep. Bart Gordon (D-Tenn.) that provides financial incentives to states that enact certificate of merit and/or early offers programs in medical liability cases.
• Health savings accounts: An amendment to clarify that health savings accounts are qualified health benefits plans that may be offered through the Health Insurance Exchange, sponsored by Rep. Michael Rogers (R-Mich.) was defeated.
• Insurance reforms: An amendment by Rep. Betty Sutton (D-Ohio) was adopted addressing limitations on preexisting condition exclusions in group and individual coverage. The committee rejected an amendment by Rep. Steve Buyer (R-Ind.) that would have allowed providers and health insurers to offer premium discounts, rebates, or modified copayments or deductibles to individuals who participate in health promotion or disease prevention programs.
• Health Benefits Advisory Committee: An amendment by Rep. Greg Walden (R-Ore.) was adopted that would require at least 25 percent of the members of the Health Benefits Advisory Committee to be health care practitioners who practice in a rural area and have done so for at least the previous five years. It also requires that the proportion of Medicare Payment Advisory Commission members who represent rural providers be proportional to the total number of Medicare beneficiaries who reside in rural areas.
• Medicaid and CHIP: Rep. Zack Space (D-Ohio) sponsored an amendment, which was adopted, that prohibits payments under Medicaid and the Children’s Health Insurance Program (CHIP) for undocumented immigrants. An amendment by Rep. Lois Capps (D-Calif.) was adopted that would eliminate copayments for certain Medicaid preventive services. Rep. Eliot Engel (D-N.Y.) successfully offered an amendment to ensure Medicaid coverage of non-emergency transportation to medical necessary services. An amendment by Rep. Peter Welch (D-Vt.) was adopted that would allow a limited exception to the maintenance of effort requirement for Medicaid. An amendment by Rep. Anna Eshoo (D-Calif.) was adopted to clarify Medicaid coverage for citizens of freely associated states (Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau). Another amendment authored by Rep. Donna Christensen (D-V.I.) that would have increased Medicaid payments to the U.S. territories was withdrawn.
• Medicare benefits: Rep. Gene Greene (D-Tex.) offered a block of amendments, all of which were adopted, addressing certain Medicare benefits. One amendment addressed payment for post-mastectomy external breast prosthesis garments. A second amendment adds "presence of impairments" to the assessments for patient-centered and population-based quality measures. The Greene amendments also require the HHS Secretary to report to Congress on Medicare barriers to abdominal aortic aneurysm screening and other preventive services approved by the U.S. Preventive Services Task Force. In addition, the Secretary would be required to make the education of physicians and patients about the risk factors for abdominal aortic aneurysm a priority.
• Medicare payments: An amendment by Rep. Ed Whitfield (Ky.) was adopted to place a moratorium on Medicare payment reductions for several interventional pain management procedures covered under the ambulatory surgery center fee schedule.
• Pharmaceuticals: An amendment by Rep. Bobby Rush (D-Ill.) was adopted that would prohibit current settlement agreements between brand-name and generic pharmaceutical companies where brand companies pay a significant sum to the first generic company that files to challenge the brand company's patent. The Federal Trade Commission would be conferred with enforcement authority to regulate such agreements. Another amendment, offered by Rep. Anna Eshoo (D-Calif.), was adopted that would confer the FDA with authority to establish an abbreviated pathway to approve biosimilars for market.
• Affordability and cost containment: Amendments offered by Rep. Janice Schakowsky (D-Ill.) and Tammy Baldwin (D-Wis.) were adopted to require savings generated through various provisions in the bill to be used to make premiums more affordable for lower income people in the exchange. The amendment offered by Rep. Baldwin would also require the Secretary of HHS to adopt operating rules for specified electronic transactions and to establish a unique health plan identifier system, and would mandate the use of electronic funds transfers under Medicare by 2015. An amendment by Rep. Phil Gingrey, MD (R-Ga.) that was rejected would have required the Secretary to develop a methodology that ensures that any savings to Medicare resulting from the Medicaid and Medicare Improvements included in the bill and amendments shall be used solely for the purpose of improving the affordability of health care for Medicare beneficiaries.AMA
• Physician hospital ownership: Rep. Joe Barton (R-Tex.) offered and withdrew an amendment that would have struck the bill’s restrictions on physician-owned hospitals. After considerable discussion, Committee Chairman Henry Waxman pledged to work with Rep. Barton to develop compromise language for later incorporation into the legislation.

View all the amendments offered during the committee debate.

The Energy and Commerce Committee is the third panel in the House to mark up H.R. 3200. Over the August recess, the three committee products will be combined into a single bill for consideration on the House floor.

For the latest developments on health system reform legislative activities and AMA advocacy efforts, please go to www.ama-assn.org/go/reform.