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The FDA has approved the single-pill Plan B One-Step emergency contraceptive for over-the-counter use without age or point-of-sale restrictions, although the two-pill version remains available to girls younger than 17 only by prescription.
The approval -- announced late Thursday -- complies with an April 4 court order by Judge Edward Korman of the U.S. District Court's Eastern District of New York mandating that all restrictions be removed from use of the emergency contraceptives.
In that ruling, Korman left open the possibility that the FDA could remove restrictions for the one-pill version and not the two-pill version if the agency "actually believes there is any significant difference between the one- and two-pill products."
The FDA exercised that option, keeping over-the-counter access to the two-pill version restricted to those 17 and older while loosening restrictions on the one-pill version. Korman accepted the plan last week.
"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," Korman wrote.
The complicated history of Plan B goes back to 1999, when the two-pill version of the levonorgestrel-containing emergency contraceptive was approved as a prescription product. In August 2006, over-the-counter access was granted to women 18 and older, although the product would still not be allowed on open store shelves.
About 2-and-a-half years later, in March 2009, Korman found that politics influenced the decision to restrict over-the-counter access to those 18 and older and ruled that the age cutoff should be dropped to 17, as the manufacturer had requested.
That summer, the FDA approved the single-pill version, which was subject to the same age restrictions.
Two years later, the FDA supported removal of all age restrictions for use of the emergency contraceptives, but Department of Health and Human Services secretary Kathleen Sebelius objected, which left the age restrictions in place.
Lawsuits followed, culminating in Korman's April decision to remove all restrictions, which also cited the influence of politics in decision-making surrounding the Plan B products.
But that wasn't the end of it. In May, just a day after approving a plan to expand over-the-counter access to Plan B One-Step to females as young as 15, the FDA appealed Korman's ruling, questioning the judge's legal powers.
Earlier this month, an appeals court stayed Korman's decision to remove age restrictions from Plan B One-Step but denied a similar motion regarding the two-pill version, effectively leaving the Korman ruling in place.
Days later, on June 10, the Justice Department informed Korman that it would no longer appeal his decision and that the FDA would ask the maker of Plan B One-Step -- Teva Women's Health -- to submit a supplemental application for approval without restrictions, which would be approved upon receipt.
Todd Neale
Senior Staff Writer
Todd Neale, MedPage Today Staff Writer, got his start in journalism at Audubon Magazine and made a stop in directory publishing before landing at MedPage Today. He received a B.S. in biology from the University of Massachusetts Amherst and an M.A. in journalism from the Science, Health, and Environmental Reporting program at New York University.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign UpBy Mary Agnes Carey, Julie Appleby, and Jenny Gold, Kaiser Health News
Testing of computer systems and training of consumer assistance guides are behind schedule, but the Obama administration has met other deadlines in its efforts to open new marketplaces where millions of consumers might shop for insurance starting this fall, according to a Government Accountability Office report released Wednesday.
The federal government expects to operate these marketplaces, also called exchanges, in 34 states that opted not to run their own. Seven of those states are working as partners with the federal government. The other 16 states are setting up marketplaces on their own with federal funding.
The report said that the Centers for Medicare & Medicaid Services, or CMS, "has many key activities remaining to be completed," including those that deal with eligibility and enrollment in the exchanges, development and implementation of a "data hub" that will connect the exchanges with other federal and state agencies to determine applicants' eligibility, and review and certification of the health insurance plans offered to consumers.
"Much remains to be accomplished within a relatively short amount of time" for the exchanges to work properly on Oct. 1, the GAO said. The "still unknown and evolving scope" of activities that CMS must provide in states that have chosen not to participate is problematic, investigators said, as are the "large number of activities remaining to be performed -- some close to the start of enrollment."
While the deadlines missed so far may not affect the law's implementation, "additional missed deadlines closer to the start of enrollment could do so," GAO found.
In a response included in the report, the Department of Health and Human Services said the agency has made progress in establishing exchanges and that the exchanges would be up and running in all states by Oct. 1.
Opponents of the health law said the report proves the measure won't work as intended and that Americans will suffer. "News of delays and missed deadlines are now just as prevalent as reports of Obamacare's broken promises and the looming rate shock in store for millions of Americans," House Energy and Commerce Committee Chairman Fred Upton, R-Mich., said in a statement.
Upton, along with Rep. Darrell Issa, R-Calif., who chairs the House Oversight and Investigations Committee, and Sen. Orrin Hatch, R-Utah, who is the top Republican on the Senate Finance Committee, requested the study.
The GAO reports that CMS is behind schedule on consumer assistance activities to the states with federal exchanges. For example, CMS was 2 months late in announcing funds to "navigators" -- community organizations and nonprofits that will hire and train people to help consumers sign up for health insurance. CMS had planned to issue the funding announcement in February, allowing enough time for two rounds of awards in July and September. Instead, the agency did not announce the grants until April, leaving time for only one round of awards, which is expected on Aug. 15.
The navigator grants will total up to $54 million for the federally run marketplaces -- "a drop in the bucket," according to Stan Dorn, a senior fellow at the nonpartisan Urban Institute. Some states received as little as $600,000. That's far less than states running their own marketplaces. California, for example, is spending $50 million to fund in-person help for consumers.
All navigators are expected to complete a web-based training and certification course. CMS had expected to begin training by July, but the course may not be ready until August.
Nonetheless, CMS officials indicated that the navigators would be available by Oct. 1, when enrollment for 2014 plans begins, according to the GAO report.
Insurers that want to sell health coverage on the exchanges had to apply by May 3, and CMS, along with help from a contractor, expects to evaluate and certify those plans by July 31, according to the GAO report. Information about those plans is expected to be available on the exchange website by Sept. 15.
The GAO analysis also took a close look at the status of the complicated technology that will be needed for the exchanges. GAO said that some limited testing has begun of the information technology systems needed to determine whether consumers seeking coverage in the marketplaces are eligible for federal subsidies and to enroll them in health coverage. But it noted that much more needs to be done before October.
"While CMS has met project schedules, several critical tasks, such as final testing with federal and state partners, remain to be completed," the report said.
Critics said the report shows that CMS and other agencies are falling behind, but others said the conclusion was that much progress has been made.
"It is the GAO's job to outline problems that could occur," said Dan Mendelson of the private consulting firm Avalere Health, but the report's conclusions are "getting spun through this lens of political discontent, so as a result, everyone is freaking out about it."
States, he said, are rightly concerned that delays in the income and eligibility information technology might not operate efficiently at first.
"That would force them to do manual enrollment -- get on the phone with people -- and that's expensive," said Mendelson, who oversaw health programs at the Office of Management and Budget during the Clinton administration.
Mark McClellan, who was in charge of the rollout of the Medicare drug benefit in 2006 for the George W. Bush administration, said testing of some IT systems for that project began not long after the law was passed in 2003. But, he said, work continued right up to and even after the program began. That rollout was initially marked by glitches that included enrollment problems, and some seniors who qualified for subsidized coverage were mistakenly told they didn't have it when they showed up at pharmacy counters.
"You are limited in what you can test ahead of time," said McClellan. Once real data starts flowing through a system, unexpected problems crop up because real data is always messier than test data sets, he said.
While the Obama administration still has time to get the testing done, McClellan said, he cautioned that "it is tight."
The GAO report also states that CMS has spent $394 million from fiscal year 2010 through March 31 of this year on various activities to get the federal funded exchanges established and listed the major contracts. CMS officials said the totals did not include agency salaries or other administrative costs.
The report on the federal insurance marketplaces was one of two on health law implementation released by GAO Wednesday. The other report looked at federal and state efforts to establish the Small Business Health Options Programs (SHOPS) in which small employers can buy coverage for their workers. In that report, GAO found that "CMS and states have made progress in establishing SHOPS, although many activities remain to be completed and some were behind schedule."
This article, which first appeared June 19, 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.
By David Pittman, Washington Correspondent, MedPage Today
WASHINGTON -- Medicaid programs and health insurance companies are hindering access to FDA-approved drugs that treat opioid addiction, according to a report released Thursday by the American Society of Addiction Medicine (ASAM).
The 216-page report -- called the "most comprehensive" on addiction medications to date -- showed wide variation in state coverage of opioid addiction medications, with many Medicaid programs requiring other treatments to fail before covering addiction drugs.
Furthermore, private insurance companies use techniques like prior authorization to restrict access to drugs like buprenorphine (Probuphine), methadone, and naltrexone (Vivitrol), the Chevy Chase, Md. group said.
The restrictions come at a time when the CDC has declared prescription opioid abuse and addiction an epidemic, with nearly 4 million Americans addicted to prescription opioids.
"We have effective ways of treating these devastating illnesses," Tom McLellan, PhD, chief executive and founder of the Treatment Research Institute -- the organization that conducted the study -- said at a press conference here. "Let's start using them."
A little more than half of state Medicaid programs (28) cover all three drugs, the report found. "However, it is important to note that the extent of coverage varies greatly among the states, and access requirements attached to any or all of these medications differ from one state to another," the authors wrote.
For example, prior authorization is required by Medicaid in 42 states for buprenorphine. Coverage limits for lifetime benefits and daily doses are also common.
The study of private insurance carriers found similar barriers in their health plans, with spotty coverage of products such as buprenorphine/naloxone (Suboxone) and injectable naltrexone.
The report shows that "we could be saving lives and effectively treating the disease of addiction if state governments and insurance companies remove roadblocks to the use of these medications," ASAM president Stuart Gitlow said at the press conference.
Removing those roadblocks, however, may be difficult for states and health plans.
Congressional limits exist on the number of patients physicians can prescribe to at once. "I have 100, and I have a waiting list of 270," Gitlow said. "I'm not coming anywhere near meeting the need, and those patients have nowhere else to go because the only other docs prescribing are full."
Also, prescribers also need a special Drug Enforcement Administration waiver created by the Drug Addiction Treatment Act of 2000 to prescribe certain opioid addiction drugs.
The FDA subjects buprenorphine-containing products to a rigorous risk evaluation and mitigation strategy (REMS) with several elements to assure safe use, including patient monitoring and prescriber certification programs. The agency has deemed the risk-benefit profile of such products unfavorable enough to try to restrict their access.
The report also examined studies that evaluated buprenorphine, methadone, injectable naltrexone, and oral naltrexone and concluded a benefit in patient outcomes as well as costs.
"I can say with no hint of opinion here, it's simple fact, they are all effective," McLellan said. "They're effective not just in reducing opioid use, they're effective in so many other ways that are important to societies and families."
He called these medications "underutilized," saying about 30% of treatment programs use such drugs and about half of the patients in those programs receive such medication.
Gitlow and McLellan called on growing a coalition of interested parties, including the various addiction medicine groups, to raise awareness on the issue and educate the public and policymakers about their needs.
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.
By David Pittman, Washington Correspondent, MedPage Today Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania
CHICAGO -- The American Medical Association's policymaking House of Delegates wrapped up its annual meeting with votes on a wide variety of subjects, from ICD-10 to sugar-sweetened drinks to gun control.
A key concern for the House is the move to ICD-10. Delegates voted that the association should lobby Congress and Medicare to ask that they require health insurers to give physicians flexibility for the first 2 years after implementation of the ICD-10 coding system, scheduled for October 2014.
During that time, according to the resolution, payers should not be allowed to deny payments to physicians for coding errors and should be required to provide feedback on why claims were denied.
Many payers have said they won't pay for unspecified codes -- a common practice if a diagnosis has not yet been determined -- or miscoded visits.
Doctors have bemoaned the switch to ICD-10 -- short for International Classification of Diseases, version 10 -- because of the tremendous increase in complexity from the current ICD-9. The number of diagnostic codes will increase from nearly 14,000 to about 69,000. The number of procedure codes will jump from around 3,000 to roughly 87,000.
The AMA will continue its fight to bypass ICD-10 completely, and go directly to ICD-11.
SGR Repeal
Another key concern for the delegates -- as it has been in previous years -- was repeal of Medicare's sustainable growth rate (SGR) formula, which determines the way physicians are paid in the program.
Doctors should be free to determine the basic method of payment that best fits their practice as the AMA lobbies for a replacement to Medicare's physician payment formula, delegates said. The AMA's policy should be to "reflect and preserve the diversity of physician-led practice models."
Lawmakers in Congress are wrestling with the issue -- payment models that reward value, quality, and efficiency have been proposed.
Delegates also voted to amend AMA policy as regards to the Affordable Care Act, calling on the organization to track the ACA's impact on health costs, coverage, and physician practice as the law moves toward full implementation starting next year.
Sugar-Sweetened Drink Ban
The AMA should work to remove sugar-sweetened beverages from the federal Supplemental Nutrition Assistance Program (SNAP), delegates voted.
"It's been shown that over half of children's intake of bad calories -- 53% to 55% -- come from the beverages they drink," Texas delegate Gary Floyd, MD, said. "We need to set this as a good example."
Some delegates complained that removing such beverages from federal aid programs would cause an undue burden on families, a point others strongly rejected.
"The point of SNAP is to provide nutritionally healthy food to these children," American Academy of Pediatrics delegate Sam Rosman, MD, said. "If they're spending those SNAP benefits on sugar-sweetened beverages they're getting empty calories and not getting the core nutrients these kids need."
The AMA House also voted to support a ban on high-energy stimulant drinks to children under age 18.
Gun-Control Measures
In another vote, the House of Delegates directed the AMA to lobby Congress to study gun-related deaths by funding and using state and national firearm injury databases, including the National Violent Data Reporting System.
Physicians should also be free to have open communication with patients about firearm safety and gun locks in their homes, according to House resolutions.
The measures were passed by unanimous consent with no debate.
A number of gun-control measures introduced were pulled from consideration just before the start of the meeting.
Pharmacy Questions
Another resolution -- labeling inquiries from pharmacies to verify the medical rationale behind prescriptions, diagnoses, and treatment plans to be interference with physician practice -- was a reflection of the extra work such requests demand as well as a stand for practice autonomy.
Pharmacies -- mostly chains -- have increasingly been querying doctors' offices to double-check the validity of prescriptions before filling them. The practice is primarily in response to a Drug Enforcement Administration crackdown on pharmacy dispensing of narcotics.
A resolution passed by the House deems these pharmacy calls "inappropriate" and directs AMA staff to voice physician concerns to pharmacies, the DEA, and other federal and state regulators.
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.
By David Pittman, Washington Correspondent, MedPage Today
WASHINGTON -- Medicare violated its own rules for its durable medical equipment (DME) bidding program by granting bids to unlicensed suppliers, according to a lawsuit filed by a durable medical equipment company and a trade group.
The American Association for Homecare -- along with Home Mediservice, a home DME supplier based in Havre de Grace, Md. -- sued the Department of Health and Human Services Wednesday seeking to stop round 2 of Medicare's competitive bidding program from starting July 1. The suit, known as American Association for Homecare et. al. v. Sebelius, was filed in the U.S. District Court for the District of Columbia.
HHS sent letters to unlicensed-yet-successful bidders in Tennessee last week, saying the department would remove all awards issued to unlicensed bidders, the Washington-based DME trade group said in its lawsuit.
"This action, however, will not put all properly licensed bidders in Tennessee in the position they would have been if the secretary had, as she was required to have done, rejected the bids submitted by unlicensed bidders," the complaint read.
They go on to say they are unaware of this happening in other states but have reason to believe it occurred.
The complaint seeks "to require the secretary to redetermine successful bidders, and recalculate the payment amount, in every state where the secretary accepted bids from unlicensed bidders, after eliminating all contracts and bids from unlicensed bidders."
Bidding instructions from April 2007 say bids will be disqualified if a bidder doesn't meet all state licensure requirements, the complaint states, adding 30 of the 98 contract suppliers in Tennessee are unlicensed. Another third of successful bidders in Maryland were unlicensed.
Round two of Medicare's competitive bidding program for durable medical equipment is slated to launch July 1 unless the court acts.
The Medicare Modernization Act -- the same law that created the program's Part D prescription drug program -- allows the Centers for Medicare and Medicaid Services to create a competitive bidding program for medical equipment. The move came in response to several government watchdog reports finding Medicare's fee schedule for medical equipment at times too high.
Initial bidding started on nine products in 2009 and is set to expand to an additional 91 products on July 1.
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.
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!
By David Pittman, Washington Correspondent, MedPage Today
More than 150 physicians and other healthcare professionals have published an open letter to President Obama asking him to allow independent physicians -- not military doctors -- to visit hunger strikers at Guantanamo Bay.
More than 100 detainees at the American military base in Cuba are believed to be starving themselves to protest their detention without a trial. Saying they don't trust military physicians, the detainees have requested independent doctors be allowed access to their medical records and granted entry to Guantanamo to treat them.
"We endorse their request, and are prepared to visit them under appropriate conditions, to assist in their recovery and release, and certify when we are confident it is medically safe for them to fly," stated the letter to Obama, which was published Tuesday in The Lancet. "We have the deepest sympathy for the hunger strikers, the military doctors, and your predicaments. We offer our services to visit, examine and advise them, and to assist in any way that is acceptable to all parties."
The letter was signed by American and international healthcare providers.
Medical professionals -- including the American Medical Association -- have expressed concern in recent weeks that the detainees aren't receiving the standard of medical care by military physicians.
The British newspaper The Guardian published a letter late last month from 13 of the detainees to their military doctor. In it, they said their doctors in Cuba have force-fed them and treated them against their will.
"As you should know, I am competent to make my own decisions about medical treatment. When I try to refuse the treatments you offer; you force them upon me, sometimes violently," the detainees wrote. "For those reasons, you are in violation of the ethics of your profession, as the American Medical Association and World Medical Association have made clear."
Outgoing AMA President Jeremy Lazarus wrote to Defense Secretary Chuck Hagel in late April to say that force-feeding prisoners against their will violates tenets of medical ethics.
"Every competent patient has the right to refuse medical intervention, including life-sustaining interventions," Lazarus said. "The AMA has long endorsed the World Medical Association Declaration of Tokyo, which is unequivocal on the point: 'Where a prisoner refuses nourishment and is considered by the physician as capable of forming an unimpaired and rational judgment concerning the consequences of such a voluntary refusal of nourishment, he or she shall not be fed artificially.'"
The AMA House of Delegates backed patients' right to refuse medical intervention in resolutions passed in 2005 and 2009.
Susan Dorr Goold, MD, incoming chair of the AMA's Council on Ethical and Judicial Affairs, noted that the issue becomes tricky in some situations, such as when detainees go on hunger strikes but then allow others to feed them. In this case, in which the detainees are just asking to allow independent doctors to visit them, "I personally think that's a very reasonable thing to do," Goold told MedPage Today at the AMA annual meeting.
AMA delegate and Air Force physician Paul Friedrichs, MD, said it was difficult for him to comment given he wasn't familiar with letter to Obama published in The Lancet.
That letter noted that since military physicians take orders from Obama -- the same man detaining them in Cuba -- it's natural for detainees not to trust military doctors.
"Without trust, safe and acceptable medical care of mentally competent patients is impossible," the letter in The Lancet stated. "Since the detainees do not trust their military doctors, they are unlikely to comply with current medical advice."
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.
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.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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!
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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.
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.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up 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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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.
By David Pittman, Washington Correspondent, MedPage Today Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania
By Ankita Rao, Kaiser Health News 
By David Pittman, Washington Correspondent, MedPage Today