HIV Experience Shaped New AMA President's Views

By David Pittman, Washington Correspondent, MedPage Today

CHICAGO -- The AIDS epidemic hit right around the time Ardis Hoven, MD, started getting heavily involved in organized medicine.

The infectious disease specialist took the insights gained from her front-line experience with the epidemic and used it to influence health policy. When she become a delegate to the American Medical Association's (AMA) policy-making House of Delegates in the early '90s, the organization was developing its policies on covering the uninsured.

"What was happening to these patients, the devastation in their lives, their loss of health insurance became a huge issue for me because I saw the implications of it," Hoven told MedPage Today. "That really empowered me, I think, to speak quite strongly for the uninsured."

She took advantage of leadership opportunities both within her home state of Kentucky and the AMA to fight for those patients and Tuesday night Hove was inaugurated as the AMA's 168th president.

"If you would have told me 20 years ago I would be doing this, I would have thought you were somewhat delusional," said Hoven, who hails from Lexington. "It really wasn't in my long-range plans by any means."

Yet she became the Kentucky Medical Association president in 1993 and served in various AMA leadership roles after that, most recently as Board of Trustees chair from 2010-2011.

But it's her experience in the clinic that most profoundly shapes her work.

"I bring to the table as a voice of the AMA real-life issues that afflict patients, that affect access to care, and affect physicians and how they practice," Hoven said.

In her inaugural address, she encouraged her fellow physicians to take an active role in reform efforts, and not passively sit on the sidelines.

"Change ... can be good," said Hoven, one of five female graduates in her medical school class at the University of Kentucky in Lexington. "Change, though, has to reflect the needs of the patients and the physicians who take care of them."

As AMA president, she will continue to push for established AMA principles, including improving health outcomes for patients and better physician satisfaction.

But physicians have to recognize that the diversity of doctors' practices in the country will take more than a one-size-fits-all model.

"We have to recognize that in Kentucky, for example, in rural eastern Kentucky, a small practice is what is there," Hoven told MedPage Today in a video interview. "It needs to be viable and doing what it needs to do for that community."

Improving medical education is another key topic for the AMA, she said. The AMA needs to help medical schools develop environments that allow students to learn to practice in team-based models, and to practice 21st-century medicine.

"We've got to make sure their education is timely," said Hoven, who wanted to be a plastic surgeon when she first started medical school. "It's competency based and yet when they come out, when they finish, they are ready to practice, they have the tools in hand, they know how to run a medical practice, they know how to do the quality work that needs to be done."

Like her recent predecessors, Hoven said repealing Medicare's sustainable growth rate (SGR) formula is a priority for her. The AMA is helping Congress draft legislation for a physician payment system to supplant the SGR, and progress is being made, she said.

"I am more optimistic now than I've been about this in a long period of time," she said. "We will continue to push on this, and I will be a person at the table frequently to talk about this."

Also on Tuesday, the House of Delegates elected Robert Wah, MD, a reproductive endocrinologist and obstetrician/gynecologist in the Washington area, to be its president-elect, who will take over as president in June 2014.

The 23-year veteran of the U.S. Navy Medical Corps now practices and teaches at Walter Reed National Military Center in Bethesda, Md., and at the National Institutes of Health.

Wah is also a recognized health information technology (IT) expert and former deputy national coordinator of Office of the National Coordinator of Health IT at the Department of Health and Human Services.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

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Distribution of Medicare ACOs Varies Widely

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By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- More than 40% of accountable care organizations (ACOs) formed under Medicare exist in only five states, leaving many states with one or none, according to an analysis by industry experts.

Medicare ACOs are concentrated in states like Florida (32), California (22), and Massachusetts (18) but rural states -- like North Dakota, South Dakota, Utah, Wyoming, Oklahoma, and Kansas -- are devoid of them, according to the analysis by consulting firm MedeAnalytics in Emeryville, Calif. Others like Montana, Idaho, Mississippi each only have one Medicare ACO.

This maldistribution problem needs to be addressed to ensure Medicare is treating the country's sickest patients in a better, more coordinated fashion, Sen. Ron Wyden (D-Ore.), said at the Fourth National ACO Summit here.

"Healthy seniors in Massachusetts can access [several] Medicare ACOs, and more vulnerable older people in Alabama have none," Wyden said, noting Alabama has the highest prevalence of diabetes in the country.

Medicare needs to better address this to help incentivize ACO development and foster care coordination in areas where it is most needed, he said.

"Medicare reimbursement should be reconfigured to target areas with the highest incidence of chronic illness and reward practitioners in those areas to improve care and hold down costs," Wyden said.

States with the highest number of Medicare ACOs -- Florida, California, Massachusetts, Texas, and New York -- all have a high number of either academic medical centers or Medicare beneficiaries, Ken Perez, director of healthcare policy at MedeAnalytics, told MedPage Today in a phone interview. Those five states combine to account for 104 of the 253 Medicare Shared Savings ACOs, he said.

Providers in rural settings will have difficulty making ACOs successful, according to David Howard, PhD, associate professor of health policy and management at Emory University in Atlanta. Most of the cost savings ACOs hope to generate come from specialists, which rural areas don't have and therefore can't integrate into ACOs.

"If patients in a rural area are leaving the area to go to specialists in cities, that's all outside the control of ACOs," Howard told MedPage Today in a video interview.

It is unknown if ACOs backed by commercial payers rather than Medicare operate in some states with few or no ACOs, Perez said. Roughly 300 such commercial ACOs exist nationwide, but MedeAnalytics doesn't track where they exist.

Whereas Medicare has 33 cost measures for its ACOs, private payers can negotiate far fewer in models they set up, giving providers greater options.

While Medicare's Shared Savings model is more rigid and might be too costly or difficult for smaller providers to establish, the program's lesser-utilized Advanced Payment model is lower-cost and lower-risk if physicians are willing to join one.

"There's no excuse for people," Perez said. "It's just they don't have the wherewithal or the population to run an ACO."

Perez noted many physicians are taking a wait-and-see approach to establishing an ACO, but it could be 3 to 5 years before it's truly known if these models will work.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

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Judge OKs FDA's Plan B One-Step Proposal

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By David Pittman, Washington Correspondent, MedPage Today

The federal judge who ordered the FDA to make the emergency contraceptive Plan B One-Step (levonorgestrel) available over the counter to women of all ages on Wednesday approved the agency's plan to comply with that order.

However, some women's rights advocates objected to the FDA's plan, saying it didn't go far enough.

But Judge Edward Korman of the U.S. District Court for the Eastern District of New York called the FDA's plan "sufficient."

After a legal and political battle over the issue, the FDA late Monday told Korman it would comply with his order to allow sales of the one-pill emergency contraceptive without age restrictions or other access limitations.

The agency will, however, continue to restrict OTC sales of the two-pill version, called simply Plan B, to those 17 and up. The FDA said there are fewer data available testing how well young girls understand and follow the instructions of the two-pill Plan B.

Attorneys representing the group who sued the FDA to remove age restrictions on the OTC emergency contraceptive told the judge Wednesday the FDA plan should have included the two-pill Plan B and other emergency contraceptives. Furthermore, the FDA didn't provide details on when it would meet the judge's order.

"More than 12 years have passed since the Citizen Petition was filed," they wrote. "Women and girls have waited long enough for the government to remove the unscientific and politically motivated barriers to emergency contraception."

Korman rejected those thoughts.

"My order ... is clear that the defendants may limit over-the-counter approval to the one-pill product if they 'actually believe' that any such difference exists," the judge wrote. "On the assumption that the Commissioner of Food and Drugs entertains the good-faith belief that the products should be treated differently, the defendants' proposal is sufficient to comply with my order."

The plaintiffs told the judge that without more alternatives to Plan B One-Step, costs would be a barrier to access for buyers.

"Nevertheless, because off-brand versions of the one-pill product are available, it is at best speculative whether the two-pill product will provide a significantly cheaper alternative," Korman wrote. "The real problem relating to cost deals with the potential period of marketing exclusivity that the FDA may grant to Teva."

The FDA late Monday told a federal judge in New York City it would comply with its order to allow sales of the one-pill emergency contraceptive Plan B One-Step without age restrictions or other access limitations. The agency will, however, continue to restrict OTC sales of the two-pill version, called simply Plan B, to those 17 and up.

Korman ruled on April 5 that the FDA had to make available levonorgestrel-based emergency contraceptives without a prescription -- and without point-of-sale or age restrictions -- within 30 days. Later that month, the FDA approved a supplemental application by sponsor Teva Women's Health to make the Plan B One-Step OTC to consumers ages 15 and up, but stopped short of making it available to all ages.

The Justice Department wrote Korman late Monday to say it would drop its appeal of his April 5 ruling following an appeals court stay of that ruling.

Plan B One-Step and Plan B both were previously available over the counter only to women 17 and older; those younger needed a prescription. Reproductive rights advocates said making the contraceptive available only with a prescription limited access for younger patients in need.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

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Britain's NHS Visits D.C. for Some Pointers

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By Ankita Rao, Kaiser Health News

In the contentious debate over healthcare in this country, the United Kingdom's single-payer, government-funded National Health Service has been held up by both sides as a system to be either emulated as an ideal or avoided as an abomination. Neither of those extreme views allows that British health providers might have something to learn from the way things are done on this side of the Atlantic.

But that is just what 20 doctors and nurses from northwest England came to do this week in Washington. The group spent the weekend dodging rain worthy of their home, and each day's schedule made time for tea. The main events were to tour Kaiser Permanente's clinic on Capitol Hill and the Veterans Affairs hospital, two giants in the U.S. healthcare delivery world, and to learn about how they each had achieved certain health outcomes while saving on the cost of care. (Kaiser Health News is not affiliated with Kaiser Permanente.)

"Our culture is different," said Dr. Robert Stead, a pulmonologist based in East Cheshire, England. "The Americans have a social police force and army, but not healthcare. In our country, there is strong national support for our system."

On Tuesday, the British contingent, part of a leadership academy with the National Health Service of Northwest England, left their teacups and saucers on the conference table to tour the Kaiser Permanente Total Health Clinic, starting with an explanation of the company's inception in 1945. Led by the clinic's medical director, Ted Eytan, MD, MS, they landed in front of a video depicting Kaiser's vision for its future, complete with smartphone programs that allow patients to perform "virtual triage" and treat their malady without entering a clinic.

"It's all IT, no new medicine," commented one physician, standing in front of a lime green wall with the words "The Future of Health Care."

"If only we had better electronic medical records," said another, echoing a common sentiment among the group that the U.K. was behind in adopting information technology to share patient information and data.

Eytan led the clinicians through a display of new technology, from a handheld, portable ultrasound to a webcam-like system for consulting doctors remotely. They stopped in between the show-and-tell to talk about the advantages of connecting patients to their doctors and nurses through regular e-mail and phone conversations.

Throughout the two-day sessions, discussion on how to improve the British system turned up buzzwords reminiscent of the U.S. health reform debate: integrated healthcare, patient-centered services, cutting the cost of care. As it turns out, the group wasn't comparing apples and oranges, but rather some sort of fruit salad, where different elements of each system could match or not.

"We're similar -- our government has shifted too, and our whole system has changed," said Deborah Arnot, a director at the NHS Leadership Academy and a nurse. "When they talk about integrated care, we can understand that."

But Arnot said there were marked differences, as well. She thought the treatment of nurses in the U.K. was more progressive -- noting that the director of nursing at their hospitals worked alongside, not under, the director of medicine.

Stead agreed that the American systems seemed more physician-led, which he said could also mean higher costs. He gave the example of how the National Health Service gave midwives more autonomy and responsibility over childbirth, rather than obstetricians, as is common in the U.S.

And the idea of multiple government programs catering to different populations -- veterans, elderly, and poor -- was quite literally a foreign concept to a group raised on the universal health system. In England, everyone has access to a primary care doctor at no cost. And if they need to access emergency care, there is no thinking of medical bills.

But Dr. James Catania, a physician and medical director in Stockport, a city near Manchester, England, said the system has its own shortcomings. General practitioners only have 10 minutes to spend with their patients, discouraging them from asking more questions or spending time talking to specialists. And while the English are happy to have universal healthcare, he said they are "frustrated with the pathways" to access that care.

"Kaiser has successfully achieved one of the foundational principles of the British system," he said.

As their trip came to an end, and with luggage stowed in the clinic, Arnot asked the group how they would like to move forward after returning to the U.K., since team members hoped to expand on some of the ideas they got during the trip. They decided to meet in 6 weeks to regroup and take stock.

Reflecting on the past 3 days, the nurses and doctors also picked apart their experiences at the clinics and what they learned. They almost unanimously said they would press the National Health Service to prioritize information technology, regardless of budget cuts. They also doled out the darts and laurels for each system.

"Their track record hasn't always been so rosy," said one member, after a colleague extolled the achievements of the Kaiser Permanente system.

Another clinician said he wanted to focus on turning the resources available into patient-centered care back at home.

"That's what I'm always banging on about," he said.

This article, which first appeared on June 13, 2013, was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.

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FDA Probes Deaths Linked to Long-Acting Zyprexa

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By John Gever, Deputy Managing Editor, MedPage Today

SILVER SPRING, Md. -- Two patients died 3-4 days after injections with the long-acting antipsychotic drug olanzapine pamoate (Zyprexa Relprevv), prompting an FDA investigation.

The agency has not determined whether the drug caused the fatalities. "At this time, FDA is continuing to evaluate these deaths and will provide an update when more information is available," it said in a statement Tuesday.

Both patients received intramuscular injections of the drug at appropriate doses, the FDA said, but tests showed "very high olanzapine blood levels after death."

High doses are known to induce delirium, cardiopulmonary arrest, cardiac arrhythmias, and impaired consciousness ranging from sedation to coma.

The long-acting form of olanzapine was approved with a risk evaluation and mitigation strategy that requires patients to remain in the clinic for a 3-hour monitoring period and to be escorted home afterward. The requirement was imposed after some patients in clinical trials became delirious or lost consciousness shortly after receiving injections.

These events, dubbed post-injection delirium-sedation syndrome (PDSS), were traced to an unexpectedly rapid release of olanzapine into circulation leading to very high blood levels of the drug.

However, all those cases occurred within hours of injection, not days, and no deaths were attributed to the syndrome, the FDA said.

Olanzapine pamoate is approved for injection every 2-4 weeks for treating patients with schizophrenia. It is one of several long-acting formulations of "atypical" antipsychotic drugs currently available. PDSS has not been seen with those other products.

John Gever

Senior Editor

John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!

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AMA Delegates Talk Payment, Contraceptives

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By David Pittman, Washington Correspondent, MedPage Today

CHICAGO -- The notion of basing physician payment on quality measures was one of several topics producing intense debate here Sunday at the American Medical Association's (AMA) annual meeting.

The AMA's policy-making House of Delegates is considering conflicting resolutions on how physicians should be paid in the future -- whether or not compensation should be based on alternative payment models that reward quality and the ability to hold down costs.

One resolution discussed at an AMA reference committee session would have the organization support a fee-for-service model; it drew a great deal of support. The resolution said fee-for-service "has many positive aspects, and should continue to be a viable payment model available to patients and physicians."

Meanwhile, a competing resolution would have AMA policy support models that base physician payment at least in part on certain performance measures as one way -- but not the only way -- to determine physician pay. Opponents noted a need for physicians to maintain their independence.

Ron Kirkland, MD, a Tennessee delegate who authored the second resolution for the American Medical Group Foundation, urged the AMA committee on legislation to allow the resolution to come before the full House of Delegates for a vote.

"The last time we let the Board of Trustees settle an issue like this, we got the Affordable Care Act," Kirkland said.

The AMA's eight reference committees will select which resolutions and reports to recommend for approval by the full House of Delegates, whose session starts Monday afternoon. The House of Delegates closes around midday Wednesday.

A separate resolution would have the AMA support over-the-counter (OTC) sale of all oral contraceptives. While the age restriction on OTC emergency contraceptives was an issue in Washington last week, this resolution dealt with all contraceptives. The AMA already supports the OTC sale of emergency contraceptives.

The resolution drew heated discussion, with testimony for and against the move roughly equal.

The American Congress of Obstetricians and Gynecologists proposed the resolution, saying some currently available OTC products such as acetaminophen are more harmful than prescription contraceptives, and making prescription contraceptives OTC could reduce unintended pregnancies.

Dan DeLoach, MD, who spoke for the Georgia delegation, called the resolution "unnecessary."

"Contraceptives are now readily available through public health departments and through many other programs that exist," DeLoach said. "This just simply offers a duplicative route or alternative for patients to obtain oral contraceptives without medical screening or medical follow-up."

The issue of gun control also caused many delegates to rise to the microphone and give their opinion. However, the discussion focused more around technical wording rather than on the need for AMA backing.

For example, many suggested changing the phrase "gun control" to "gun safety" -- with the latter phrase seen as a less contentious way to frame the issue.

The delegates are considering a spate of issues involving guns, including a resolution that would have the AMA lobby Congress to remove restraints on the collection of data around gun injuries and deaths. Another proposal would force the AMA to educate physicians and patients about the use of gun locks.

Many delegates also -- not so surprisingly -- spoke in favor of a handful of motions against the controversial Maintenance of Certification (MOC) programs.

One resolution supported Sunday would authorize the AMA to advocate against time-limited certification and oppose discrimination against physicians who are not certified in MOC programs. In another, the MOC program is described as "costly, time intensive, and result[ing] in significant disruptions to the availability of physicians."

A third resolution seeks to add transparency to the American Board of Medical Specialties -- which oversees MOC programs -- by having the AMA call for the organization and component specialty boards to release detailed reports on revenue, expenses, and salaries of senior staff and board members.

Leah McCormack, MD, a delegate from New York -- the delegation which offered many of the anti-MOC resolutions -- said the MOC programs were "insulting" to her, as a physician who works on her own to maintain her education.

"We don't feel that this [MOC] is the way for everyone," said McCormack, adding that she attends conferences, reads journals, and completes other continuing medical education programs.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

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Supreme Court Says No Patents on Natural Genes

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By Joyce Frieden, News Editor, MedPage Today

WASHINGTON -- Synthetically created combinations of DNA are not naturally occurring and are therefore patent-eligible, but whole genes such as BRCA1 and BRCA2 occur naturally and can't be patented, the Supreme Court ruled unanimously Thursday.

"The Patent Act permits patents to be issued to '[w]hoever invents or discovers any new and useful ... composition of matter,' but 'laws of nature, natural phenomena, and abstract ideas' are 'basic tools of scientific and technological work' that lie beyond the domain of patent protection," wrote Justice Clarence Thomas in the 9-0 decision.

The ruling came in a case entitled Association for Molecular Pathology v. Myriad Genetics. The petitioners argued that genes are a product of nature and therefore patents on BRCA1 and BRCA2 genes held by biotechnology firm Myriad Genetics were invalid. Salt Lake City-based Myriad Genetics argued that it could legally patent the genes because once they were isolated from the body, they were no longer a product of nature.

Mutations in BRCA1 and BRCA2 genes raise a woman's risk of developing breast and ovarian cancer.

A district court in 2010 ruled the patents invalid because they were products of nature. The Court of Appeals for the Federal Circuit in 2011 disagreed, setting up the case for the Supreme Court.

During oral arguments at the Supreme Court in April, Chief Justice John Roberts said he disagreed with the appellate court's reasoning. In that court, the judges likened the patents to the patenting of a baseball bat. A tree isn't patent eligible, but a bat -- once extracted from the tree and carved -- is eligible.

"The baseball bat is quite different," Roberts said. "You don't look at a tree and say, 'well, I've cut the branch here and cut it here and all of a sudden I've got a baseball bat.' You have to invent it, if you will."

Justice Stephen Breyer said he supported allowing companies like Myriad to be able to patent the process by which they find and extract certain gene segments -- just not genes themselves.

In its decision invalidating Myriad's patent, the Supreme Court said that "Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes ... Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself" meet the criteria for a patent.

In addition, "Myriad's claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together," Thomas wrote. "The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, they focus on the genetic information encoded in the BRCA1 and BRCA2 genes."

The justices said that it is important to note "what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad's patents ... and are not at issue in this case."

The ruling "is a validation that things that are wrong can be made right," Arupa Ganguly, PhD, one of the original plaintiffs in the case, told MedPage Today in a phone interview. "I'm ecstatic."

Ganguly, a professor of genetics at the University of Pennsylvania in Philadelphia, said her laboratory was asked by Myriad in 1999 to "cease and desist" from doing BRCA1 and BRCA2 tests because of Myriad's patents.

The ruling means a lot for patients because "testing can improve, prices can be controlled, and people can have more access" to the tests, Ganguly said, noting that before the patents were invalidated, researchers could do work on a patient's blood sample but could not share their test results with patients.

The ruling will allow more companies to get into the market for BRCA1 and BRCA2 tests, increasing competition and driving down prices, said Rebecca Nagy, MS, president of the National Society for Genetic Counselors.

The ruling "appears to ... open up the test to other labs as long as the technique they use goes straight from naturally occurring DNA," said Nagy, a certified genetic counselor at Ohio State University in Columbus. "That will have a huge impact on how we practice and on delivering services to these women."

The ruling was "somewhat of a compromise" because it still allows patenting of composite DNA (cDNA), she noted. "If the [genetic] test utilizes genomic DNA -- which many of them now do -- and they don't have to create a step to do cDNA, another lab is free to use that [test]."

Although most genetic tests today use whole DNA, there are some cases in which testing is more complete if cDNA is used, Nagy said.

Some have argued that invalidating the patents will discourage biotechnology firms from developing genetic tests, but Ganguly disagreed. "The commercial research is not about the natural [gene] sequence," she said. "The commercial interest is what you do with that gene sequence. Do you design something new? Or find a new pathway to target for therapy? That will go on just like before."

Joyce Frieden

News Editor

Joyce Frieden began her career in medical journalism 26 years ago at Harcourt Brace Jovanovich, working as a news editor for Physician’s Management, Modern Medicine, Hospital Formulary, and several other medical magazines. Since then, her byline has appeared in Business & Health magazine, Internal Medicine News, Family Practice News, Pediatric News, Clinical Psychiatry News, Skin and Allergy News and ObGyn News. Her freelance clients have included Physician’s Weekly, UPI, WebMD, Reuters Health, Drug Topics, the Washington Post, and Washingtonian magazine. She is the recipient of a Jesse H. Neal award presented for editorial excellence by American Business Media, and is co-coordinator of the Washington chapter of the Association of Health Care Journalists.

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Students, Docs in Training Boost AMA Rolls

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By David Pittman, Washington Correspondent, MedPage Today

CHICAGO -- The American Medical Association's membership rolls grew by nearly 7,000 in 2012, and almost two-thirds of the new members were either students or residents, reports revealed.

There were 2,6oo new medical student members in 2012 and more than 1,800 new residents, according to the membership report presented at the AMA policy-making House of Delegates meeting here. The two classes of members represent 22.2% and 17% of AMA membership, respectively.

Overall in 2012, AMA membership ticked upward by 3.2% to 224,503 by the end of last year.

Membership growth was more modest among older physicians. The number of members ages 65 and older went up by about 650. About 1,400 members between ages 40 and 65 joined. Around 750 doctors under age 40, or in their first 8 years of practice, became members.

James Madara, MD, AMA executive vice president, noted that the organization has undertaken multiple membership initiatives in the past year. For example, the AMA has a policy that if the leaders of an academic organization join, everybody in the organization receives a discount on membership fees.

"To what degree any of that or all of that had an impact is hard to separate out," Madara told MedPage Today.

The 2012 increase marks the second straight year membership has gone up, following a nearly 5% loss from 2009 to 2010. Nearly 12,000 of doctors allowed their dues to lapse during that time, citing the AMA's backing of the Affordable Care Act as their reason for pulling out of the organization.

Despite being the nation's largest physician group, the AMA has been criticized for not representing a larger percentage of doctors.

Just under 19% of the 1.2 million physicians and medical students were AMA members in 2012, according to the group's membership report for that year. In comparison, national medical specialty societies can count about 80% of eligible physicians as members.

The 2009-2010 decline came after just a brief uptick in membership, which fell for 10 straight years until it stopped in 2005. The group called 244,005 individuals as members that year, 20,000 more than in 2012.

The bump in 2012 membership translated to more money in the AMA coffers.

Dues revenue in 2012 -- at $1.2 million -- matched the 3.2% growth in membership. Gross revenue was $38.9 million in 2012.

Dues for medical students are $20 a year; they are $45 a year for residents. Physicians in their first year of practice pay $210 in dues, those in their second year pay $315. Dues are $420 for a regular membership.

The AMA's Board of Trustees recommended no changes in the dues structure for 2014.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

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Supreme Court Split on Pharma ‘Pay for Delay’ Deals

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By Joyce Frieden, News Editor, MedPage Today

So-called "pay-for-delay" arrangements between generic and brand-name drug companies are not inherently legal, and each instance must be considered on a case-by-case basis, the Supreme Court ruled Monday.

In the 5-3 decision overruling the 11th Circuit Court of Appeals, Justice Stephen Breyer, writing for the majority, listed five reasons why the appellate court erred in giving blanket immunity to pay-for-delay agreements, in which brand-name drugmakers pay or compensate generic drug companies in exchange for a later entry date of the cheaper generic version of a drug: "A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects""One who makes such a payment may be unable to explain and to justify it""Such a firm or individual may well possess market power derived from the patent""A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent""Parties may well find ways to settle patent disputes without the use of reverse payments"

"In our view, these considerations, taken together, outweigh the single strong consideration -- the desirability of settlements -- that led the Eleventh Circuit to provide near-automatic antitrust immunity to reverse payment settlements," Breyer wrote.

Justice Samuel Alito recused himself from the vote.

The case, known as Federal Trade Commission vs. Actavis, involved Solvay Pharmaceuticals, which was granted a patent for AndroGel -- a topical testosterone medication for hypogonadism -- in 2003, 3 years after getting FDA approval for the drug. Later that year, generic drugmaker Actavis filed an Abbreviated New Drug Application for a generic version of the drug, as did Paddock Laboratories. Solvay then sued Activas and Paddock but settled with them in 2006 under a pay-for-delay agreement.

Under the settlement, Actavis agreed not to market its generic until the end of August, 2015, 65 months prior to the expiration of Solvay's patent. In return, Solvay agreed to pay Actavis $19-30 million a year for 9 years. Solvay made similar agreements with Paddock and with a third company, Par Pharmaceutical, which had joined forces with Paddock to litigate the patent claim.

The Federal Trade Commission (FTC) -- which claims that such pay-for-delay agreements cost American consumers $3.5 billion a year in the form of higher drug prices -- sued Solvay in 2009, claiming the settlement violated antitrust laws. The Eleventh Circuit rejected the FTC's arguments, ruling that as long as the settlement didn't extend beyond the patent expiration it was legal and not an antitrust violation.

"In our view ... reverse payment settlements such as the agreement alleged in the complaint before us can sometimes violate the antitrust laws," Breyer wrote for the court. "We consequently hold that the Eleventh Circuit should have allowed the FTC's lawsuit to proceed."

On the other hand, the justices said they refused to automatically designate all pay-for-delay settlements as illegal.

"The likelihood of a reverse payment bringing about anticompetitive effects depends upon its size, its scale ... and the lack of any other convincing justification," Breyer wrote. "The existence and degree of any anticompetitive consequence may also vary as among industries. These complexities lead us to conclude that the FTC must prove its case as in other rule-of-reason cases."

"The rationale behind a payment of this size cannot in every case be supported by traditional settlement considerations," he continued. "The payment may instead provide strong evidence that the patentee seeks to induce the generic challenger to abandon its claim with a share of its monopoly profits that would otherwise be lost in the competitive market."

In their dissent, Justices Antonin Scalia and Clarence Thomas, led by Chief Justice John Roberts, argued that patents represent exceptions to antitrust laws.

"The correct approach should therefore be to ask whether the settlement gives Solvay monopoly power beyond what the patent already gave it," Roberts wrote for the dissenting justices. "The Court, however, departs from this approach, and would instead use antitrust law's amorphous 'rule of reason' to inquire into the anticompetitive effects of such settlements. This novel approach is without support in any statute, and will discourage the settlement of patent litigation."

In carving out this new approach, "the majority today departs from the settled approach separating patent and antitrust law, weakens the protections afforded to innovators by patents, frustrates the public policy in favor of settling, and likely undermines the very policy it seeks to promote by forcing generics who step into the litigation ring to do so without the prospect of cash settlements," Roberts concluded. "I would keep things as they were and not subject basic questions of patent law to an unbounded inquiry under antitrust law."

Joyce Frieden

News Editor

Joyce Frieden began her career in medical journalism 26 years ago at Harcourt Brace Jovanovich, working as a news editor for Physician’s Management, Modern Medicine, Hospital Formulary, and several other medical magazines. Since then, her byline has appeared in Business & Health magazine, Internal Medicine News, Family Practice News, Pediatric News, Clinical Psychiatry News, Skin and Allergy News and ObGyn News. Her freelance clients have included Physician’s Weekly, UPI, WebMD, Reuters Health, Drug Topics, the Washington Post, and Washingtonian magazine. She is the recipient of a Jesse H. Neal award presented for editorial excellence by American Business Media, and is co-coordinator of the Washington chapter of the Association of Health Care Journalists.

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Firmer Breast Implant Gets FDA Nod

Crystal Phend

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Crystal Phend joined MedPage Today in 2006 after roaming conference halls for publications including The Medical Post, Oncology Times, Doctor's Guide, and the journal IDrugs. When not covering medical meetings, she writes from Silicon Valley, just south of the San Francisco fog.

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Public Citizen's Wolfe Still Needling FDA

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By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- Sidney Wolfe, MD, can talk for as long as you let him about how he got his start in consumer health advocacy.

Wolfe was in his mid-30s in March 1971. He had just finished his residency and was doing hematology research at the National Institutes of Health when he received a call from a fellow resident.

The physician was concerned that the FDA and CDC weren't recalling contaminated intravenous fluids that had caused severe bacterial infections and dozens of deaths. Neither Wolfe nor his colleague considered the CDC recommendation to keep administering the fluids unless patients developed an infection to be correct.

After some research proving a direct link between the IV fluids and infections -- and verifying with some hospitals that a recall wouldn't cause a shortage -- Wolfe sent the FDA a letter demanding that the agency get the manufacturer to recall the fluids, and went on a media campaign with the evidence.

Two days later, the fluids were recalled.

The work was so fulfilling and satisfying that it made him shift career goals entirely, thus beginning the work of what he calls "research-based advocacy."

"I was just tracked to be in academic medicine, to be an internist, take care of patients," Wolfe told MedPage Today during an interview at his Washington office. "And it just changed my career."

That career took a turn -- but isn't over -- when Wolfe stepped down early last week as director of Public Citizen's Health Research Group, an organization that has been a leading public interest voice in health policy. He'll remain on board as the group's "founder and senior adviser." Wolfe's deputy of 3 years, Mike Carome, MD, will take over leadership.

'Gadfly' to Pharma, Organized Medicine

In his more than 40 years at Public Citizen, Wolfe has gone on to be a "thorn in the side of organized medicine," as some have called him. Former President George W. Bush referred to him as a "gadfly" to the pharmaceutical industry.

Public Citizen's Health Research Group -- which Wolfe formed with consumer advocate Ralph Nader -- was officially formed 8 months after the IV fluid recall, as they petitioned the FDA to ban Red Dye #2, which was believed to cause cancer.

Wolfe's group has asked the FDA to ban 35 drugs in the 40-plus years of its work, "not a whole lot," he said. But the agency has followed through on 25 of the group's requests -- about a 70% success rate.

He has questioned the FDA's ability to oversee the safety of drugs since Nixon was in the White House.

"Other people do research, and I had done plenty of research by then," Wolfe said. "But the next step is what do you do with this. In some cases, you're just learning things and there really isn't anything to do. In other cases, you're learning that there is a problem that the FDA ... isn't doing anything about, and what can you do to try to change that?"

At the end of his first year with Public Citizen, Wolfe had enjoyed his work so much that he told Nader, "This will be the last job I ever have."

He was then 36. He turned 76 this week.

But he doesn't have a single favorite piece of work. Asked what he is most proud of, he lists among his successes his warning about rofecoxib (Vioxx) years before it was taken off the market. The FDA also acted on Public Citizen's request to ban valdecoxib (Bextra). Wolfe's group got a warning against Reye's syndrome put on the side of aspirin bottles, and got silicone breast implants restricted.

"I just think about what's at the end," Wolfe said. "Are these people getting something that isn't even reasonably likely to cause any benefit beyond other things that are safe?"

Wolfe also said he has few regrets. He points to individual drugs like celecoxib (Celebrex), rosuvastatin (Crestor), or lorcaserin (Belviq) that Public Citizen pushed against approval of, but are still on the market. "There are individual regrets like that, but mainly not very much."

Aside from the drug world, Wolfe has probed state medical boards, questioning why some are slow to take action on physicians and why others give relative slaps on the wrist. His book "Questionable Doctors" listed every doctor in the U.S. who had been disciplined over 10 years.

What's Next?

While Wolfe is leaving as director and handling the day-to-day operations, he isn't stopping his work with Public Citizen. He considers himself in good health mentally and physically but wants to cut back to a 40- or 45-hour work week -- something he hasn't had in decades.

One of the projects he hopes to take on involves a deeper look at the role the Prescription Drug User Fee Act (PDUFA) has played in the agency's approving drugs with questionable safety issues.

"Too many times now, a drug comes up, there's a safety problem, and they say, 'Well, there's a safety question, but we need to make the PDUFA deadline. We'll approve it and do the study afterward,'" Wolfe told MedPage Today in a video interview. "It clearly has an impact."

He referenced a 1998 survey of FDA medical officers which found that of the nearly one-third who responded, about half had a decision not to approve a drug overturned by a higher authority at the agency. More had been told not to express very negative views about a drug at an advisory committee.

With a lighter work week, Wolfe may also have a chance to spend more time at his grand piano -- a result of his 1990 MacArthur Foundation "genius grant" of $320,000. The rest went to helping pay off debts incurred for his daughters' education.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

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Berwick Enters Mass. Governor's Race

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By Joyce Frieden, News Editor, MedPage Today

Former acting Medicare chief Donald Berwick, MD, has announced that he is running for governor of Massachusetts.

"I feel proud of and grateful to this state, and I want to find the best way to give back," Berwick said in an announcement posted Monday on his campaign website.

"As a doctor, an educator, an innovator and someone who has dedicated his professional career to making things work better and to helping people -- I am ready to lead. That is why I am announcing today that I am a candidate for Governor of Massachusetts."

Berwick, 66, served as acting administrator of the Centers for Medicare and Medicaid Services (CMS) from July 2010 to December 2011. He left after it became clear that President Obama, who had named Berwick to the position in a recess appointment, would be unable to have his nomination as permanent administrator approved by the Senate.

During his tenure, Berwick was lauded for his commitment to patient safety. He also urged health insurers to work more closely with CMS to implement health reform.

Berwick was criticized by Senate Republicans for making statements praising aspects of the British healthcare system, which is government-run -- statements Republicans cited as proof that he favored rationing healthcare. Berwick denied wanting to ration care and said he thinks the solution to America's healthcare woes should be uniquely American and not modeled on any other country.

Berwick was succeeded as acting administrator by Marilyn Tavenner, who was recently confirmed by the Senate.

On his campaign website, Berwick, who is running as a Democrat, praises Massachusetts' system of universal health coverage. "Massachusetts should be proud that ours was the first state in the nation to make healthcare a human right," the site says.

"But that is not going to be sustainable without major changes and improvements in healthcare delivery -- improvements that Don has been working on worldwide for the last 3 decades. The best route to sustainable care is to improve care, and that is a cornerstone of Don's agenda. But that means helping our amazing healthcare organizations navigate through a difficult change to team-based, integrated, truly patient-centered care, with an emphasis on prevention and healing."

Prior to his stint at CMS, Berwick founded and led the Institute for Healthcare Improvement, which focuses on sharing "best practices" among physicians to improve healthcare delivery. Berwick is a graduate of Harvard Medical School and also worked at the Harvard Community Health Plan.

Joyce Frieden

News Editor

Joyce Frieden began her career in medical journalism 26 years ago at Harcourt Brace Jovanovich, working as a news editor for Physician’s Management, Modern Medicine, Hospital Formulary, and several other medical magazines. Since then, her byline has appeared in Business & Health magazine, Internal Medicine News, Family Practice News, Pediatric News, Clinical Psychiatry News, Skin and Allergy News and ObGyn News. Her freelance clients have included Physician’s Weekly, UPI, WebMD, Reuters Health, Drug Topics, the Washington Post, and Washingtonian magazine. She is the recipient of a Jesse H. Neal award presented for editorial excellence by American Business Media, and is co-coordinator of the Washington chapter of the Association of Health Care Journalists.

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CDC: Cut Back on Doxycycline Use

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By Cole Petrochko, Staff Writer, MedPage Today

A continuing shortage of doxycycline means the drug should be used only for conditions that have no alternative treatments, the CDC advised this week.

Manufacturing issues and increased demand have resulted in drug shortages of some formulations of doxycycline -- including doxycycline hyclate and doxycycline monohydrate -- since Jan. 18, 2013, according to an agency statement. The drug is available from most manufacturers currently, but healthcare professionals may need to find new contacts to order supplies.

Additionally, the intravenous formulation of doxycycline hyclate and the oral suspension doxycycline calcium have not been subject to the shortage.

The CDC recommended that healthcare professionals limit use of the short-supply drugs to the following uses: Treatment of rickettsial infectionsProphylaxis against Lyme disease following a tick biteProphylaxis and treatment of malaria, "according to the standard recommendations"

The agency also noted that alternative treatments exist for STDs and Lyme disease and that providers "should use clinical judgment in making treatment and prophylactic decisions."

In rickettsial infections, such as Rocky Mountain spotted fever and anaplasmosis, patients of all ages should receive doxycycline to prevent severe morbidity and mortality. The CDC warned that delaying treatment until test results are in is "highly contraindicated." Other broad-spectrum antibiotics are ineffective at treating such conditions. Chloramphenicol should be used as an alternative only if a patient has a specific, life-threatening contraindication to doxycycline.

Although there are no other drugs that act as an effective prophylaxis against Lyme disease, the agency noted that alternatives for treatment of the disease include amoxicillin and cefuroxime axetil.

To determine the best course for prevention and treatment of malaria, the CDC referred healthcare professionals to its website, noting that there are several drugs that are effective prophylactics and treatments for the condition.

"Healthcare professionals should ensure they have access to doxycycline for the listed indications, and advance planning is essential to ensure treatment is not delayed," the agency said, adding that sites that cannot access supplies or that find prices raised during the shortage seek alternate distributors, contact manufacturers directly, or contact state health officials.

Updates on drug shortages are available on the American Society of Health-System Pharmacists website.

Cole Petrochko

Staff Writer

Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today's Little Falls, N.J. Headquarters.

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D.C. Week: Surgeon General to Leave in July

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By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- The woman holding the position known as "America's doctor" took to Twitter this week to make it known she was stepping down.

Regina Benjamin Bows Out as Surgeon General

Surgeon General Regina Benjamin, MD, announced late Wednesday she will leave her post in July after 4 years on the job.

No reason was immediately given about why the sudden announcement came, but she indicated she wanted to spend time this summer volunteering at the rural health clinic in South Alabama she helped to found, a Department of Health and Human Services (HHS) spokeswoman said.

"She has served as America's doctor since 2009 and has impacted the health and lives of Americans across the country," HHS spokeswoman Dori Salcido said in a statement. "We are grateful for her leadership and service."

Court Says No to Human Gene Patents

Synthetically created combinations of DNA are not naturally occurring and are therefore patent-eligible, but whole genes such as BRCA1 and BRCA2 occur naturally and can't be patented, the Supreme Court ruled unanimously Thursday.

The Association for Molecular Pathology argued that patents on BRCA1 and BRCA2 genes held by biotechnology firm Myriad Genetics were invalid because they are a product of nature. Salt Lake City-based Myriad argued it could legally patent the genes because once they were isolated from the body, they were no longer a product of nature.

Mutations in BRCA1 and BRCA2 genes raise a woman's risk of developing breast and ovarian cancer.

FDA Drops Age Limits on Plan B One-Step OTC Sales

The federal judge who ordered the FDA to make the emergency contraceptive Plan B One-Step (levonorgestrel) available over the counter to women of all ages on Wednesday approved the agency's plan to comply with that order.

After a legal and political battle over the issue, the FDA late Monday told Korman it would comply with his order to allow sales of the one-pill emergency contraceptive without age restrictions or other access limitations.

Physician groups on Tuesday were generally supportive of the FDA decision to expand over-the-counter OTC access to Plan B One-Step.

Medicare to Pay for More FDG-PET Scans

Up to three scans using 18F-fluorodeoxyglucose-enhanced positron emission tomography (FDG-PET) technology can be covered by Medicare for oncology treatment planning, the Centers for Medicare and Medicaid Services (CMS) announced Tuesday.

The agency's final decision expands significantly on its earlier proposal, which would have allowed reimbursement for only a single FDG-PET scan and excluded prostate cancer as a covered indication.

Both limitations were dropped in CMS' final coverage determination. The agency said it now agrees with numerous comments it received on the draft proposal, which argued that FDG-PET scans are valuable in treatment planning in prostate cancer as they are for other tumor types.

Medicare Advantage Plans Keep Growing

More Medicare beneficiaries than ever are enrolled in a Medicare Advantage plan, despite concerns that payment cuts to the plans made by the Affordable Care Act would cause providers to drop out and enrollment to drop.

Medicare Advantage plans enrolled a record 14.4 million customers in 2013, up nearly 10% from last year, a Kaiser Family Foundation analysis said Monday.

Medicare Advantage enrollment has grown nearly 30% since 2010.

Senator Praises CMS Fraud Rewards

Senate Special Committee on Aging Chairman Bill Nelson (D-Fla.) wrote late Monday to CMS to support a proposed rule that would increase rewards for individuals who report suspected Medicare fraud.

The proposed rule would increase the cap on potential reward payouts from $1,000 to $9.9 million.

Nelson urged CMS Administrator Marilyn Tavenner to pay rewards in a timely manner and to make sure that the program is properly managed.

Lawmakers Want Review of Federal Mental Health Programs

Members of the Energy and Commerce Oversight and Investigations Subcommittee want the Government Accountability Office (GAO) to ensure taxpayer dollars to treat the mentally ill are being used effectively.

The subcommittee's top Republican and Democrat asked the GAO on Friday to investigate how federal departments and agencies support mental illness programs and how they oversee those programs.

They also asked the GAO to investigate the nearly $1 billion in grants the Substance Abuse and Mental Health Services Administration administers through its Center for Mental Health Services.

Next Week

On Tuesday, the Senate Finance Committee will hold a hearing on healthcare price transparency.

On Thursday, the House Ways and Means Health Subcommittee will hold a hearing on the recently released Medicare trust fund report.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

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Undocumented Immigrants' Share of Health Bill Relatively Small

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By Charles Bankhead, Staff Writer, MedPage Today

Healthcare for unauthorized immigrants accounted for 1.4% of all healthcare spending in the U.S. over the past decade, according to an analysis of government data.

Total healthcare spending for immigrants -- unauthorized, legal, and naturalized -- from 2000 to 2009 amounted to $96.5 billion. Unauthorized immigrants accounted for $15.4 billion of the total.

During the same time period, U.S. natives rang up more than $1 trillion in healthcare spending, as reported online in Health Affairs.

"Our study found that unauthorized immigrants have lower healthcare expenditures and higher rates of receiving uncompensated care than legal residents, naturalized citizens, and U.S. natives," Jim P. Stimpson, PhD, of the University of Nebraska in Omaha, and coauthors concluded. "This finding is largely attributed to a history of policies that block access to healthcare for this population."

Ongoing debate regarding immigration reform and implementation of the Affordable Care Act provides opportunities to address immigrants' access to healthcare, "assuming that there is the political will to do so," they added.

Several recent studies have examined healthcare expenditures by residency status, and all found lower spending on healthcare among immigrants than among people born in the US. At least one study found that the proportion of unauthorized immigrants without health insurance has increased in recent years, the authors noted in their introduction.

Collectively, the findings from recent studies imply that restricted access to health insurance among unauthorized immigrants may lead to higher out-of-pocket health spending and higher rates of uncompensated care for providers. However, the potential results have yet to be established by research, the authors continued.

To add to the knowledge base regarding residency status and healthcare spending, Stimpson and colleagues analyzed data from the Medical Expenditure Panel Survey (MEPS) for 2000 to 2009. The MEPS population comprises a random sample of participants in the National Health Interview Survey. Key findings from the MEPS analysis included: 60% of unauthorized immigrants had healthcare expenditures during any 12-month period compared with 72% for legal residents, 83% of naturalized citizens, and 87% of U.S. nativesU.S. natives accounted for 91.4% of healthcare expenditures annually during the study period, versus 4.7% for naturalized citizens, 2.5% for legal residents, and 1.4% for unauthorized immigrantsPer-capita annual healthcare spending averaged about $500 for unauthorized immigrants, about $1,000 for legal residents, $2,300 for naturalized citizens, and $2,500 for U.S. nativesProviders' uncompensated care averaged 5.9% among unauthorized immigrants, 4.7% for legal residents, 2.3% for naturalized citizens, and 2.8% for U.S. natives

The study showed that 7.9% of unauthorized immigrants received publicly funded healthcare, averaging $140 per person per year. That compared with 30.1% of U.S. natives, at $1,385 per person per year. For each dollar of public spending for healthcare, unauthorized immigrants had almost $8 from private sources, as compared with $1.76 for U.S. natives.

The findings are consistent with those of another recent study showing that immigrants pay more to Medicare than they receive. In 2009, immigrants accounted for 14.7% of contributions to the Medicare trust fund versus 7.9% of expenditures.

Potential policy solutions related to healthcare for unauthorized immigrants could include extending coverage for prevention and treatment of infectious diseases or granting access to the ACA's insurance market, the authors suggested.

The authors reported no relevant disclosures.

Charles Bankhead

Staff Writer

Working from Houston, home to one of the world's largest medical complexes, Charles Bankhead has more than 20 years of experience as a medical writer and editor. His career began as a science and medical writer at an academic medical center. He later spent almost a decade as a writer and editor for Medical World News, one of the leading medical trade magazines of its era. His byline has appeared in medical publications that have included Cardio, Cosmetic Surgery Times, Dermatology Times, Diagnostic Imaging, Family Practice, Journal of the National Cancer Institute, Medscape, Oncology News International, Oncology Times, Ophthalmology Times, Patient Care, Renal and Urology News, The Medical Post, Urology Times, and the International Medical News Group newspapers. He has a BA in journalism and MA in mass communications, both from Texas Tech University.

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Project Expands Reach of Mental Health Providers

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By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- A video teleconference system that connects specialists with community health providers to provide better care for patients in underserved areas is expanding to mental health, thanks to a grant announced Friday.

The GE Foundation will provide $4.6 million to the University of New Mexico Health Sciences Center in Albuquerque to expand its Project ECHO to increase access to mental health and addiction services.

The Project ECHO model -- ECHO is short for Extension for Community Healthcare Outcomes -- allows specialists at a center like the university's to electronically connect with community providers to discuss complex cases and help those providers better treat their patients.

Backers of the movement hope others will catch on to the model to better integrate mental health specialists into primary care.

Once a week, providers at these community clinics link via videoconferencing to specialists in order to present and discuss more challenging cases. Over time, the primary care providers in that community setting become more adept at handling these complex cases, Sanjeev Arora, MD, founder of Project ECHO at New Mexico, said at an event here.

Unlike with traditional telemedicine, however, there is no patient interaction.

Arora started the work to treat hepatitis C patients, finding 5% of those needing treatment in New Mexico were actually getting it. Now, 15 centers come together weekly to discuss complex cases.

"After hepatitis C, we found out the second biggest problem was this issue of addiction and mental health," Arora said. "There were no psychiatrists in rural New Mexico."

The $4.6 million from the GE Foundation will provide this program to eight community health centers, which will use the money to recruit nurse practitioners and community health workers to focus specifically on treating addictions and mental health.

They will work with higher-level providers to identify patients in need, develop a treatment plan, and implement that plan.

The Project ECHO model could help with all underserved areas, supporters say, and could work in both rural and urban areas.

Bob Corcoran, president of the GE Foundation, said 85% of mental healthcare shortcomings are in rural areas.

Because patients are not seen from electronic face to an electronic face like with traditional telemedicine, it has been difficult to get payers to reimburse this type of telehealth effort.

"That's the mindset that we need to get over as a country that there are other ways to care for the patient than having the patient and doctor look at each other in real time," Coleen Kivlahan, MD, senior director of healthcare affairs at the Association of American Medical Colleges, said, adding she hopes payers will catch on.

John Lumpkin, MD, senior vice president and director of the Health Care Group at the Robert Wood Johnson Foundation -- which is also helping to fund the Project ECHO expansion -- said a push to more coordinated care and efforts by payers to incentivize lowering spending will force providers to develop methods like Project ECHO to care for difficult, hard-to-reach patients.

"As we begin to see these integrated care systems develop, how do you get the expertise out to the docs who are doing the ambulatory care?" he asked. "ECHO. You can begin to bake it into these integrated care delivery systems."

Lumpkin noted the Department of Veterans Affairs has piloted a nationwide program with Project ECHO, and the Defense Department has done the same with a global chronic pain management program.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

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